PROXY STATEMENT FOR 2016 ANNUAL MEETING OF STOCKHOLDERS
ABOUT THIS DOCUMENT
Synta Pharmaceuticals Corp., which we refer to herein as the "Company," "Synta," "we," "our," or "us," is providing these proxy
materials in connection with the solicitation by our board of directors of proxies to be voted at our annual meeting of stockholders to be held at 9:00 am, local time, on July 21, 2016,
at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Center, Boston, MA 02111, or at any adjournment or postponement thereof, or Annual Meeting. This proxy statement
and the enclosed proxy card will be mailed to each stockholder entitled to notice of, and to vote at, the Annual Meeting commencing on or about June 13, 2016.
You
should rely only on the information contained in or incorporated by reference into this proxy statement. No one has been authorized to provide you with information that is different
from that
contained in or incorporated by reference into this proxy statement. This proxy statement is dated June 8, 2016. You should not assume that the information contained in this proxy statement is
accurate as of any other date, nor should you assume that the information incorporated by reference into this proxy statement is accurate as of any date other than the date of such incorporated
document. The mailing of this proxy statement to our stockholders will not create any implication to the contrary.
Except
where specifically noted, the following information and all other information contained in this proxy statement does not give effect to the proposed reverse stock split described
in Proposal No. 2, beginning on page 156 in this proxy statement.
This proxy statement does not constitute an offer to sell, or a solicitation of an offer to buy, any securities, or the solicitation of a proxy, in any
jurisdiction in which or from any person to whom it is unlawful to make any such offer or solicitation in such jurisdiction.
REFERENCES TO ADDITIONAL INFORMATION
This proxy statement incorporates important business and financial information about Synta that is not included in or delivered with
this document. You may obtain this information without charge through the Securities and Exchange Commission (the "SEC") website (www.sec.gov) or upon your written or oral request by contacting the
Wendy E. Rieder, Senior Vice President, General Counsel of Synta Pharmaceuticals Corp., 125 Hartwell Avenue, Lexington, MA 02421 or by calling (781) 274-8200.
You
may also request information from The Proxy Advisory Group, LLC, Synta's proxy solicitor, at the following address and telephone number:
The Proxy Advisory Group, LLC
Shareholders Call Toll Free: (888) 337-7699, or 888-33PROXY
For
additional details about where you can find information about Synta, please see the section entitled "Where You Can Find More Information" in this proxy statement.
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QUESTIONS AND ANSWERS ABOUT THE MERGER
Except where specifically noted, the following information and all other information contained in this proxy statement does not give
effect to the proposed reverse stock split described in Proposal No. 2, beginning on page 156 of this proxy statement.
The
following section provides answers to frequently asked questions about the merger. This section, however, provides only summary information. Please refer to the more detailed
information contained elsewhere in this proxy statement and the annexes to and the documents referred to or incorporated by references in this proxy statement.
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Q.
-
Why am I receiving this proxy statement?
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A:
-
You are receiving this proxy statement because you have been identified as a stockholder of Synta as of the
record date for the 2016 annual meeting of stockholders, or the Annual Meeting. You are being asked to vote at the Annual Meeting to approve, among other things, the issuance of shares of Synta common
stock as contemplated by the Merger Agreement. This document serves as a proxy statement of Synta used to solicit proxies for the Annual Meeting.
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Q:
-
What is the merger?
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A:
-
Synta and Madrigal Pharmaceuticals, Inc., or Madrigal, have entered into an Agreement and Plan of
Merger and Reorganization, dated as of April 13, 2016, which we refer to as the Merger Agreement. The Merger Agreement contains the terms and conditions of the proposed business combination of
Synta and Madrigal. Under the Merger Agreement, Saffron Merger Sub, Inc., a wholly-owned subsidiary of Synta, or Saffron Merger Sub, will merge with and into Madrigal, with Madrigal surviving
as a wholly-owned subsidiary of Synta. Thereafter, Synta will change its corporate name to "Madrigal Pharmaceuticals, Inc." as required by the Merger Agreement. This transaction is referred to
as "the merger."
At
the effective time of the merger, each share of Madrigal common stock outstanding immediately prior to the effective time of the merger will be converted into the right to receive 5.5740 shares of
Synta common stock, subject to adjustment to account for the proposed reverse stock split to be implemented prior to the closing of the merger.
As
a result, immediately following the completion of the merger, Madrigal's current securityholders would own in the aggregate approximately 64% of the combined company's outstanding common stock
(with Bay City Capital, LLC, or Bay City Capital, and its affiliates, Madrigal's largest securityholder, owning approximately 52.5% of the combined company's outstanding shares of common stock) and
Synta's current holders of common stock and restricted stock units (together referred to as Synta's equityholders) would own in the aggregate approximately 36% of the combined company's outstanding
common stock. This calculation does not contemplate outstanding Synta option awards, which will remain outstanding under their existing terms following the merger, nor does it include equity awards in
the amount of 20,825,936 shares of common stock of the combined company that are expected to be granted immediately after the completion of the merger to Paul A. Friedman, M.D., and Rebecca
Taub, M.D., as executive officers of the combined company.
For
a more complete description of what Madrigal stockholders will receive in the merger, please see the section entitled "The Merger AgreementMerger Consideration" beginning on
page 99.
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Q:
-
What will happen to Synta if, for any reason, the merger does not close?
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A:
-
If, for any reason, the merger does not close, the Synta board of directors may elect to, among other things,
attempt to complete another strategic transaction like the merger, attempt to sell or
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otherwise
dispose of the various assets of Synta or continue to operate the business of Synta. If Synta decides to dissolve and liquidate its assets, Synta would be required to pay all of its debts
and contractual obligations and to set aside certain reserves for potential future claims, and there can be no assurances as to the amount or timing of available cash left to distribute to
stockholders after paying the debts and other obligations of Synta and setting aside funds for reserves in the event of such a liquidation.
If
Synta were to continue its business, it would need to re-evaluate its strategic direction relating to STA-12-8666, including potentially submitting an Investigational New Drug Application, or IND,
for STA-12-8666, and may need to identify, acquire and develop other products or product candidates. In addition, as of June 1, 2016, the Synta workforce was comprised of nine employees, most
of whom are involved in general and administrative roles. Synta has only one employee currently engaged in development and regulatory activities. If Synta decides to re-evaluate its current business
alternatives, Synta may need to hire managerial and other personnel to lead and staff a variety of necessary functions, including in particular research, development and commercialization.
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Q:
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Why are the two companies proposing to merge?
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A:
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Madrigal and Synta believe that the merger will result in a financially strong pharmaceutical company focused
on the development of novel small-molecule drugs addressing major unmet needs in cardiovascular, metabolic and liver diseases. Madrigal and Synta expect that the combined company will have the
resources to fund the development of MGL-3196, a Phase 2-ready, once-daily, oral, liver-directed, selective thyroid hormone receptor-ß, or THR-ß, agonist for the
treatment of non-alcoholic steatohepatitis, or NASH, heterozygous familial hypercholesterolemia, or HeFH, and homozygous familial hypercholesterolemia, or HoFH, through Phase 2 clinical studies
in NASH, HeFH and HoFH. For a discussion of Synta's reasons for the merger, please see the sections entitled "The MergerBackground of the Merger" beginning on page 67 and "The
MergerReasons for the Merger" beginning on page 76.
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Q:
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How much cash will Synta have at the closing of the merger?
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A:
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It is a closing condition of the Merger Agreement that Synta have net cash of at least $28.5 million
at the closing of the merger. The actual amount of net cash will depend mostly on the timing of the closing.
-
Q:
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What is required to complete the merger?
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A:
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To complete the merger, Synta stockholders must approve the issuance of Synta common stock to Madrigal
securityholders by virtue of the merger as contemplated by the Merger Agreement and the amendment to the restated certificate of incorporation of Synta effecting the reverse stock split.
The
approval of the Merger Agreement, the merger and the issuance of shares of Synta common stock requires the affirmative vote of a majority of the votes cast on this proposal at the Annual Meeting.
The approval of the reverse stock split requires the affirmative vote of the holders of a majority of the outstanding shares of Synta common stock entitled to vote on the record date for the Annual
Meeting. The approval of the reverse stock split is required in order to authorize Synta's issuance of the shares of its common stock pursuant to the Merger Agreement and to maintain the listing of
Synta common stock on The NASDAQ Global Market or The NASDAQ Capital Market. However, if the requisite number of stockholders of Synta approve the Merger Agreement, the merger and the issuance of
shares of Synta common stock but do not approve the reverse stock split, the merger will not be completed.
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In
addition to the requirement of obtaining such stockholder approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.
Also,
certain Synta stockholders who, in the aggregate, own approximately 18.2% of the outstanding shares of Synta common stock, are parties to voting agreements with Synta and Madrigal whereby the
stockholders agreed to vote in favor of the issuance of Synta common stock in the merger as contemplated by the Merger Agreement.
For
a more complete description of the closing conditions under the Merger Agreement, you are urged to read the section entitled "The Merger AgreementConditions to Completion of the
Merger" beginning on page 110 of this proxy statement.
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Q:
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Are there any federal or state regulatory requirements that must be complied with or federal or state regulatory approvals or
clearances that must be obtained in connection with the merger?
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A:
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Neither Synta nor Madrigal is required to make any filings or obtain any approvals or clearances from any
antitrust regulatory authorities in the United States or other countries to consummate the merger. In the United States, Synta must comply with applicable federal and state securities laws and The
NASDAQ Stock Market's rules and regulations in connection with the issuance of the shares in connection with the merger, including the filing with the SEC, of this proxy statement. Synta has filed an
initial listing application with The NASDAQ Global Market or The NASDAQ Capital Market pursuant to The NASDAQ Stock Market's "change of control" rules. If such application is accepted, Synta
anticipates that Synta's common stock will be listed on The NASDAQ Global Market or The NASDAQ Capital Market following the closing of the merger under the trading symbol "MDGL."
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Q:
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Will holders of the Synta common shares issued in the merger be able to trade those
shares?
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A:
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The shares of Synta common stock issued as consideration in the merger will be issued in transactions exempt
from registration under the Securities Act of 1933 as amended, or the Securities Act, in reliance on Section 4(a)(2) of the Securities Act, and Regulation D promulgated thereunder and
may not be offered or sold by the holders of those shares absent registration or an applicable exemption from registration requirements. As a general matter, holders of such shares will not be able to
transfer any of their shares until at least six months after receiving shares of Synta common stock, which is when the shares would first be eligible to be sold under Rule 144 promulgated under
the Securities Act, assuming the conditions thereof are otherwise satisfied. In connection with the merger, however, Synta has agreed to file with the SEC a registration statement on Form S-3
to register the shares of Synta common stock received in the merger for resale in the public markets. Upon such registration statement being declared effective by the SEC, such shares shall become
freely tradeable subject to certain limitations for stockholders deemed to be affiliates of the combined company.
However,
all securityholders of Madrigal, and each director and executive officer of Madrigal, have agreed to certain transfer restrictions on all of their Synta shares from April 13, 2016
until 180 days after
the closing date of the merger. See the section in this proxy statement entitled "Agreements Related to the MergerLock-Up Agreements" for more detail.
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Q:
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Who will be the directors of Synta following the completion of the merger?
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A:
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The combined company's board of directors will initially be fixed at seven members, consisting of
(i) one member designated by Synta, Keith R. Gollust, the current Chairman of the board of directors of Synta, (ii) one member to be mutually agreed upon by Synta and Madrigal meeting
the SEC and NASDAQ independence requirements, and (iii) five members designated by Madrigal, namely Paul A. Friedman, M.D., who will be the Chairman; Rebecca Taub, M.D.;
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Fred Craves,
Ph.D., who will be the lead director and who currently is the founder and managing director of Bay City Capital (which together with its affiliates will own approximately 52.5% of
the combined company's outstanding shares of common stock immediately following the closing of the merger); Kenneth M. Bate and one additional Madrigal designee who meets the SEC and NASDAQ
independence requirements. The staggered structure of the current Synta board of directors will remain in place for the combined company following the completion of the merger, provided that Keith R.
Gollust will be re-appointed as a Class III director.
Pursuant
to the terms of the Merger Agreement, it is anticipated the director classes of the combined company board of directors will be as follows:
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-
Class I directors (term ending 2017): Paul A. Friedman, M.D. and Kenneth M. Bate;
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Class II directors (term ending 2018): Rebecca Taub, M.D. and Fred Craves, Ph.D.; and
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Class III directors (term ending 2019): Keith R. Gollust, one mutual designee and one Madrigal designee.
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Q:
-
Who will be the executive officers of Synta immediately following the completion of the
merger?
-
A:
-
Immediately following the completion of the merger, the executive management team of Synta is expected to be
composed of Paul A. Friedman, M.D., serving as the Chief Executive Officer and Chairman of the Board of the combined company, Rebecca Taub, M.D., serving as Chief Medical Officer, Executive Vice
President, Research & Development and Director of the combined company, and Marc R. Schneebaum serving as Chief Financial Officer of the combined company.
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Q:
-
Am I entitled to appraisal rights?
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A:
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Holders of Synta common stock are not entitled to appraisal rights in connection with the merger.
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Q:
-
Have Madrigal's stockholders adopted the Merger Agreement and approved the merger?
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A:
-
Yes. On April 13, 2016, all of Madrigal's stockholders adopted the Merger Agreement and approved the
merger and related transactions. Accordingly, no appraisal rights are available to Madrigal stockholders in connection with this transaction.
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Q:
-
What are the material U.S. federal income tax consequences of the merger to Synta
stockholders?
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A:
-
Each of Synta and Madrigal intends the merger to qualify as a reorganization within the meaning of
Section 368(a) of the Internal Revenue Code of 1986, as amended, or the Code. Since Synta stockholders will continue to own and hold their existing shares of Synta common stock following the
merger, the merger generally will not result in U.S. federal income tax consequences to Synta stockholders.
However,
tax matters are very complicated and the tax consequences to a particular Synta stockholder will depend on such stockholder's circumstances. Accordingly, you should consult your tax advisor
for a full understanding of the tax consequences of the merger and reverse stock split to you, including the applicability and effect of federal, state, local and foreign income and other tax laws.
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Q:
-
Do persons involved in the merger have interests that may conflict with mine as a Synta
stockholder?
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A:
-
Yes. When considering the recommendation of the Synta board of directors, you should be aware that certain
members of the Synta board of directors and named executive officers of Synta have interests in the merger that may be different from, or in addition to, interests they may have as
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Synta
stockholders. The Synta board of directors was aware of the following interests and considered them, among other matters, in its decision to approve the Merger Agreement.
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Continued Service with Combined Company
At
the effective time of the merger, the officers of the combined company will include:
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Paul A. Friedman, M.D., a director of Synta from March 2014 until his resignation on April 13, 2016 concurrent
with the announcement of the merger with Madrigal, who will be the Chief Executive Officer and Chairman of the combined company;
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Rebecca Taub, M.D., a current executive officer of Madrigal who will be the Chief Medical Officer, Executive Vice
President, Research & Development and Director, of the combined company; and
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-
Marc R. Schneebaum, the current Chief Financial Officer of Synta, who will continue as the Chief Financial Officer of the
combined company.
Additionally,
Keith R. Gollust, currently a director of Synta, will continue as a director of the combined company after the effective time of the merger.
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-
Synta Director Paul A. Friedman's Relationship with Madrigal and the Combined Company
Dr. Friedman
has personal interests both in Madrigal and the combined company. These interests were fully disclosed to and known by the Synta board of directors and corporate governance
measures were taken to address them, including Dr. Friedman's exclusion from Synta board of director proceedings with respect to Madrigal, as described more fully in "The
MergerBackground of the Merger." These interests are:
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-
The current Chief Executive Officer of Madrigal, Rebecca Taub, M.D. and Dr. Friedman are married.
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Upon the closing of the merger, Dr. Friedman and Dr. Taub will be employed as executive officers of the
combined company as described above.
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Dr. Friedman and Dr. Taub have irrevocably committed to loan approximately $5 million to Madrigal in
the form of promissory notes that will convert into 25,905,930 shares of Synta common stock as part of the merger closing.
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-
Dr. Friedman and Dr. Taub will have significant beneficial ownership interests in the combined company due
in part to the post-closing entity's equity compensation arrangements with Dr. Friedman and Dr. Taub. Assuming the full vesting and exercise of options to purchase 14,875,669 shares of
common stock and the vesting 5,950,267 shares of restricted stock, and based on the projected number of shares of Synta common stock to be outstanding immediately after the closing,
Dr. Friedman and Dr. Taub would have a pro forma stock ownership of 60,493,023 shares of the combined company, or approximately 14.5% immediately after the closing of the merger.
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Other
Upon
a termination of employment in connection with the merger, Synta's named executive officers may receive cash severance payments and other benefits with a total value of approximately
$3.2 million (collectively, not individually, and including the value of the accelerated vesting of unvested restricted stock awards and the vesting of restricted stock unit awards).
See
"The MergerBackground of the Merger" beginning on page 67 and "The MergerInterests of the Synta Directors and Executive Officers in the Merger" beginning on
page 90.
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Q:
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Why is Synta seeking stockholder approval of the merger and the issuance of shares of common stock issuable upon the
merger?
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A:
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Because our common stock is listed on The NASDAQ Capital Market, we are subject to The NASDAQ Stock Market
Listing Rules. Rule 5635(a) of The NASDAQ Stock Market listing standards requires stockholder approval with respect to issuances of Synta common stock, among other instances, when the shares to
be issued are being issued in connection with the acquisition of the stock of another company and are equal to 20% or more of Synta's outstanding common stock before the issuance. Rule 5635(b)
of the The NASDAQ Stock Market listing standards requires stockholder approval when any issuance or potential issuance will result in a change of control of the issuer. Although The NASDAQ Stock
Market has not adopted any rule on what constitutes a "change of control" for purposes of Rule 5635(b), The NASDAQ Stock Market has previously indicated that the acquisition of, or right to
acquire, by a single investor or affiliated investor group, as little as 20% of the common stock (or securities convertible into or exercisable for common stock) or voting power of an issuer could
constitute a change of control.
In
addition, Rule 5635(d) of The NASDAQ Stock Market Listing Rules requires stockholder approval if a listed company issues common stock or securities convertible into or exercisable for common
stock in a private placement equal to 20% or more of the common stock or 20% or more of the voting power outstanding before the issuance for less than the greater of book or market value of the stock.
Following
the closing of the merger, the current Madrigal securityholders are expected to own approximately 64% of the aggregate number of shares of Synta common stock (with Bay City Capital and its
affiliates, Madrigal's largest securityholder, owning approximately 52.5% of the combined company's outstanding shares of common stock) and the Synta equityholders as of immediately prior to the
effective time of the merger are expected to own approximately 36% of the aggregate number of shares of Synta common stock. This calculation does not contemplate outstanding Synta option awards, which
will remain outstanding under their existing terms following the merger, nor does it include equity awards in the amount of 20,825,936 shares of common stock of the combined company that are expected
to be granted immediately after the completion of the merger to Paul A. Friedman, M.D. and Rebecca Taub, M.D., as executive officers of the combined company.
-
Q:
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As a Synta stockholder, how does the Synta board of directors recommend that I
vote?
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A:
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After careful consideration, the Synta board of directors unanimously recommends that Synta stockholders vote
"FOR" Proposal Nos. 1 through 8. For a detailed description of each of Proposal Nos. 1 through 8, see the section entitled "Matters Being Submitted to a Vote of Synta Stockholders"
beginning on page 155.
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Q:
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What risks should I consider in deciding whether to vote in favor of the merger?
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A:
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You should carefully review the section of this proxy statement entitled "Risk Factors," beginning on
page 26, which sets forth certain risks and uncertainties related to the merger, risks and uncertainties to which the combined company's business will be subject, and risks and uncertainties to
which each of Synta and Madrigal, as an independent company, is subject.
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Q:
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What is "golden parachute" compensation and why I am being asked to vote on it?
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A:
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The SEC has adopted rules that require Synta to seek an advisory (non-binding) vote on "golden parachute"
compensation. "Golden parachute" compensation is compensation that is tied to or based on the merger and that will or may be paid by Synta to its named executive officers in connection with the
merger.
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-
Q:
-
When do you expect the merger to be completed?
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A:
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Synta and Madrigal anticipate that the merger will occur soon after the Annual Meeting, which is expected to
occur in the third quarter of 2016, but Synta cannot predict the exact timing. For more information, please see the section entitled "The Merger AgreementConditions to Completion of the
Merger" beginning on page 110.
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Q:
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What do I need to do now?
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A:
-
You are urged to read this proxy statement carefully, including its annexes, and to consider how the merger
affects you.
You
may provide your proxy instructions by mailing your signed proxy card in the enclosed return envelope, vote by Internet or telephone, or vote in person at the Annual Meeting. Please provide your
proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the Annual Meeting.
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Q:
-
What constitutes a quorum at the Annual Meeting?
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A:
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The presence at the Annual Meeting, in person or by proxy, of the holders of a majority of the shares of
Synta common stock issued and outstanding on the record date for the Annual Meeting will constitute a quorum for the transaction of business at the Annual Meeting.
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Q:
-
What happens if I abstain?
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A:
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Shares abstaining from voting on a matter will be counted for the purpose of determining whether a quorum
exists for the Annual Meeting, but are treated as having not voted. Abstentions will have the same effect as voting against Proposal Nos. 1 and 2, but will have no impact on the outcome of the
vote for Proposal Nos. 3, 4, 5, 6, 7 and 8.
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Q:
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If my Synta shares are held in "street name" by my broker, will my broker vote my shares for
me?
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A:
-
Unless your broker has discretionary authority to vote on certain matters, your broker will not be able to
vote your shares of Synta common stock without instructions from you. Brokers are not expected to have discretionary authority to vote for Proposal Nos. 1, 3, 4, 5, 6 or 8. To make sure that
your vote is counted, you should instruct your broker to vote your shares, following the procedures provided by your broker.
-
Q.
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How Do I Vote?
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A.
-
Whether you plan to attend the Annual Meeting or not, we urge you to vote by proxy. All shares represented by
valid proxies that we receive through this solicitation, and that are not revoked, will be voted in accordance with your instructions on the proxy card or as instructed via Internet or telephone. You
may specify whether your shares should be voted for the nominee for director and whether your shares should be voted for, against or to abstain with respect to each of the other proposals. If you
properly submit a proxy without giving specific voting instructions, your shares will be voted in accordance with the board of directors' recommendations as noted below. Voting by proxy will not
affect your right to attend the Annual Meeting. If your shares are registered directly in your name through our stock transfer agent, Computershare Trust Company, N.A., or you have stock certificates
registered in your name, you may vote:
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By
mail.
If you received a proxy card by mail, you can vote by mail by completing, signing, dating and returning the proxy card as
instructed on the card. Your proxy will be voted in accordance with your instructions. If you sign the proxy card but do not specify how you want your shares voted, they will be voted as recommended
by our board of directors below.
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-
By Internet or by
telephone.
Follow the instructions on the proxy card to vote by Internet or telephone.
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-
In person at the
meeting.
If you attend the meeting, you may deliver your completed proxy card in person or you may vote by completing a ballot, which
will be available at the meeting.
Telephone
and Internet voting facilities for stockholders of record will be available 24-hours a day and will close at 1:00 a.m., Central Time, on July 21, 2016.
If
your shares are held in "street name" (held in the name of a bank, broker or other holder of record), you will receive instructions from the holder of record. You must follow the instructions of
the holder of record in order for your shares to be voted. Telephone and Internet voting also will be offered to stockholders owning shares through certain banks and brokers.
-
Q:
-
May I vote in person at the Annual Meeting?
-
A:
-
If your shares of Synta common stock are registered directly in your name with the Synta transfer agent, you
are considered to be the stockholder of record with respect to those shares, and the proxy materials and proxy card are being sent directly to you by Synta. If you are a Synta stockholder of record,
you may attend the Annual Meeting and vote your shares in person. Even if you plan to attend the Annual Meeting in person, Synta requests that you sign and return the enclosed proxy to ensure that
your shares will be represented at the Annual Meeting if you are unable to attend. If your shares of Synta common stock are held in a brokerage account or by another nominee, you are considered the
beneficial owner of shares held in "street name," and the proxy materials are being forwarded to you by your broker or other nominee together with a voting instruction card. As the beneficial owner,
you are also invited to attend the Annual Meeting. Because a beneficial owner is not the stockholder of record, you may not vote these shares in person at the Annual Meeting unless you obtain a proxy
from the broker, trustee or nominee that holds your shares, giving you the right to vote the shares at the meeting.
-
Q:
-
When and where is the Annual Meeting being held?
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A:
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The Annual Meeting will be held at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.,
One Financial Center, Boston, MA 02111, at 9:00 am, local time, on July 21, 2016. Subject to space availability, all Synta stockholders as of the record date, or their duly appointed proxies,
may attend the Annual Meeting.
-
Q:
-
May I change my vote after I have submitted a proxy or provided proxy
instructions?
-
A:
-
Synta stockholders of record, other than those Synta stockholders who are parties to voting agreements, may
revoke their proxy at any time before their proxy is voted at the Annual Meeting in one of three ways. First, a stockholder of record of Synta can send a written notice to the Secretary of Synta
stating that it would like to revoke its proxy. Second, a stockholder of record of Synta can submit new proxy instructions on a new proxy card. Third, a stockholder of record of Synta can attend the
Annual Meeting and vote in person. Attendance alone will not revoke a proxy. If a Synta stockholder of record or a stockholder who owns Synta shares in "street name" has instructed a broker to vote
its shares of Synta common stock, the stockholder must follow directions received from its broker to change those instructions.
-
Q:
-
Who is paying for this proxy solicitation?
-
A:
-
Synta will bear its own expenses in printing and filing this proxy statement and the proxy card. Arrangements
will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Synta common stock for the forwarding of solicitation
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materials
to the beneficial owners of Synta common stock. Synta will reimburse the brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with
the forwarding of solicitation materials to beneficial owners of Synta common stock. We have engaged The
Proxy Advisory Group, LLC to advise us on certain proposals in this proxy statement. We have engaged The Proxy Advisory Group, LLC to assist in the solicitation of proxies and provide
related advice and informational support, for a services fee and the reimbursement of customary disbursements that are not expected to exceed $25,000 in the aggregate.
-
Q:
-
Who can help answer my questions?
-
A:
-
If you are a Synta stockholder and would like additional copies, without charge, of this proxy statement or
if you have questions about the merger, including the procedures for voting your shares, you should contact:
Synta Pharmaceuticals Corp.
125 Hartwell Avenue
Lexington, MA 02421
Tel: (781) 274-8200
Attn: Wendy E. Rieder, Senior Vice President, General Counsel
You
may also request information from The Proxy Advisory Group, LLC, Synta's proxy solicitor, at the following address and telephone number:
The Proxy Advisory Group, LLC
Shareholders Call Toll Free: (888) 337-7699, or 888-33PROXY
10
Table of Contents
SUMMARY
This summary highlights selected information from this proxy statement and may not contain all of the
information that is important to you. To better understand the merger and the
proposals being considered at the Annual Meeting, you should read this entire proxy statement carefully, including the Merger Agreement attached as Annex A, the opinion of Roth Capital
Partners, LLC attached as Annex B and the other annexes to which you are referred herein. For more information, please see the section entitled "Where You Can Find More Information"
beginning on page 247.
The Companies
Synta Pharmaceuticals Corp.
125
Hartwell Avenue
Lexington, MA 02421
(781) 274-8200
Synta
is a company that has been historically focused on research, development and commercialization of novel oncology medicines with the potential to change the lives of cancer
patients. In October 2015, Synta announced the decision to terminate for futility the Phase 3 GALAXY-2 trial of its novel heat shock protein 90 (Hsp90) inhibitor, ganetespib, and docetaxel in
the second-line treatment of patients with advanced non-small cell lung adenocarcinoma. Based on the review of a pre-planned interim analysis, the study's Independent Data Monitoring Committee (IDMC)
concluded that the addition of ganetespib to docetaxel was unlikely to demonstrate a statistically significant improvement in overall survival, the primary endpoint of the study, compared to docetaxel
alone. Synta continues to conduct limited activities with respect to ganetespib and the drug candidates from its proprietary Hsp90 inhibitor Drug Conjugate, or HDC program, including STA-12-8666.
Madrigal Pharmaceuticals, Inc.
500
Office Center Drive, Suite 400
Fort Washington, PA 19034
(610) 527-6790
Madrigal
is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutic candidates for the treatment of cardiovascular,
metabolic and liver diseases. Madrigal's lead product candidate, MGL-3196, is a proprietary, liver-directed, selective thyroid hormone receptor-ß, or THR-ß, agonist that can
potentially be used to treat a number of disease states with high unmet medical need. Madrigal is developing MGL-3196 for non-alcoholic steatohepatitis, or NASH, and is planning to conduct a
Phase 2 clinical trial in this indication. Madrigal is also developing MGL-3196 for dyslipidemia, particularly genetic dyslipidemias such as familial hypercholesterolemia, or FH, including both
homozygous and heterozygous forms of the disease. Madrigal is planning to conduct two Phase 2 clinical trials in FH, one in heterozygous FH patients and one a proof-of-concept clinical trial in
homozygous FH patients. MGL-3196 is a once-daily oral pill that has been studied in three completed Phase 1 trials in a total of 115 subjects. MGL-3196 appeared to be safe and well-tolerated in
these trials, which included a single ascending dose trial, a multiple ascending dose trial, and a drug interaction trial with a statin.
Saffron Merger Sub, Inc.
Saffron Merger Sub, Inc., or Saffron Merger Sub, is a wholly-owned subsidiary of Synta, and was formed solely for the purposes
of carrying out the merger.
11
Table of Contents
The Merger
(see page 67)
If
the merger is completed, Saffron Merger Sub will merge with and into Madrigal, with Madrigal surviving as a wholly-owned subsidiary of Synta.
At
the effective time of the merger, each share of Madrigal common stock outstanding immediately prior to the effective time of the merger will be converted into the right to receive
5.5740 shares of Synta common stock, subject to adjustment to account for the reverse stock split to be implemented prior to the closing of the merger.
Following
the completion of the transactions contemplated by the Merger Agreement, the current securityholders of Madrigal and current equityholders of Synta are expected to own 64% and
36% of the combined company, respectively. This calculation does not contemplate outstanding Synta option awards, which will remain outstanding under their existing terms following the merger, nor
does it include equity awards in the amount of 20,825,936 shares of common stock of the combined company that are expected to be granted immediately after the completion of the merger to Paul A.
Friedman, M.D., and Rebecca Taub, M.D., as executive officers of the combined company.
Each
share of Synta common stock issued and outstanding at the time of the merger will remain issued and outstanding and those shares will be unaffected by the merger. Synta stock
options and other equity awards that are outstanding immediately prior to the effective time of the merger will also remain outstanding and be unaffected by the merger. Please see "The
MergerStock Options" beginning on page 96.
The
merger will be completed as promptly as practicable after all of the conditions to completion of the merger are satisfied or waived, including the approval of the stockholders of
Synta. Synta and Madrigal are working to complete the merger as quickly as practicable and expect that the merger will be completed during the third quarter of 2016. However, Synta and Madrigal cannot
predict the exact timing of the completion of the merger because it is subject to various conditions. After completion of the merger, Synta will be renamed "Madrigal Pharmaceuticals, Inc."
Reasons for the Merger
(see pages 67 and
76)
Synta's
board of directors considered numerous factors in reaching its conclusion to approve the merger and to recommend that the Synta stockholders approve
the issuance of shares of Synta common stock in the merger, including those discussed under the sections entitled "The MergerBackground of the Merger" beginning on page 67 and "The
MergerReasons for the Merger" beginning on page 76 of this proxy statement.
Opinion of Roth Capital Partners, LLC as Synta's Financial Advisor
(see page 78)
Roth
Capital Partners, LLC, or Roth, the financial advisor of Synta, delivered to the board of directors of Synta a written opinion dated
April 13, 2016, addressed to the board of directors of Synta, as of that date and subject to and based on the assumptions made, procedures followed, matters considered, limitations of the
review undertaken and qualifications contained in the written opinion, as to the fairness, from a financial point of view, to Synta of the merger consideration to be paid by Synta in the merger
pursuant to the Merger Agreement. The full text of this written opinion provided to the Synta board of directors, which describes, among other things, the assumptions made, procedures followed,
factors considered, qualifications and limitations on the review undertaken, is attached as Annex B to this proxy statement and is incorporated by reference in its entirety. Holders of Synta
common stock are encouraged to read the opinion carefully in its entirety.
The Roth opinion was provided to the board of directors of Synta in connection with its evaluation of
the consideration provided for in the merger. It does not address any other aspect of the merger or any alternative to the
12
Table of Contents
merger and does not constitute a recommendation as to how any stockholders of Synta should vote or act in connection with the merger or otherwise.
Overview of the Merger Agreement
Merger Consideration
(see page 99)
At
the effective time of the merger each outstanding share of common stock of Madrigal immediately prior to the effective time of the merger will automatically
be converted into the right to receive 5.5740 shares of Synta common stock, subject to adjustment to account for the reverse stock split to be implemented prior to the closing of the merger.
As
a result, following the completion of the merger, Madrigal's current securityholders would own in the aggregate approximately 64% of the combined company's outstanding common stock
(with Bay City Capital and its affiliates, Madrigal's largest securityholder, owning approximately 52.5% of the combined company's outstanding shares of common stock) and Synta's equityholders would
own in the aggregate approximately 36% of the combined company's outstanding common stock. This calculation does not contemplate outstanding Synta option awards, which will remain outstanding under
their existing terms following the merger, nor does it include equity awards in the amount of 20,825,936 shares of common stock of the combined company that are expected to be granted immediately
after the completion of the merger to Paul A. Friedman, M.D., and Rebecca Taub, M.D., as executive officers of the combined company.
The
Merger Agreement does not include a price-based termination right, so there will be no adjustment to the total number of shares of Synta common stock that Madrigal stockholders will
be entitled to receive for changes in the market price of Synta common stock. Accordingly, the market value of the shares of Synta common stock issued pursuant to the merger will depend on the market
value of the shares of Synta common stock at the time the merger closes, and could vary significantly from the market value on the date of this proxy statement.
Conditions to Completion of the Merger
(see page 110)
To
complete the merger, Synta stockholders must approve the issuance of shares of Synta common stock to Madrigal stockholders by virtue of the merger and an
amendment to the restated certificate of incorporation of Synta effecting the proposed reverse stock split. In addition to obtaining such stockholder approvals, each of the other closing conditions
set forth in the Merger Agreement must be satisfied or waived.
No Solicitation
(see page 105)
The
Merger Agreement contains provisions prohibiting Synta and Madrigal from seeking a competing transaction, subject to specified exceptions described in the
Merger Agreement. Under these "no solicitation" provisions, each of Synta and Madrigal has agreed, subject to specified exceptions, that neither it nor its subsidiaries, nor any of its officers,
directors, employees, representatives, affiliates, advisors or agents will directly or indirectly:
-
-
initiate, solicit, seek or knowingly encourage or support any inquiries, proposals or offers that constitute or may reasonably be
expected to lead to any competing proposal;
-
-
engage or participate in, or knowingly facilitate, any discussions or negotiations regarding, or furnish any nonpublic information to
any person in connection with, any inquiries, proposals or offers that constitute, or may reasonably be expected to lead to, a competing proposal;
13
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-
-
enter into any letter of intent, agreement in principle or other similar type of agreement relating to a competing proposal, or enter
into any agreement or agreement in principle requiring either Synta or Madrigal, as the case may be, to abandon, terminate or fail to complete the merger; or
-
-
resolve, propose or agree to do any of the foregoing.
Termination of the Merger Agreement
(see page 113)
Either
Synta or Madrigal can terminate the Merger Agreement under certain circumstances, which would prevent the merger from being completed.
Termination Fee
(see page 113)
The
Merger Agreement provides that, upon termination of the Merger Agreement under specified circumstances, Synta may be required to pay Madrigal a termination
fee of $1.25 million, or reimburse Madrigal for up to $250,000 in certain transaction-related expenses, or Madrigal may be required to pay Synta a termination fee of $1.0 million.
Madrigal Private Placement
(see pages 115 and 224)
On
April 13, 2016, Madrigal entered into an amended and restated senior secured note purchase agreement, or the 2016 purchase agreement, with certain
investors, including Bay City Capital, pursuant to which Madrigal agreed to issue, and the investors agreed to purchase, $9 million in aggregate principal amount of convertible notes before or
concurrent with the completion of the merger, which we refer to as the new notes. The new notes bear interest at a rate of 8% per annum. Pursuant to the 2016 purchase agreement, Bay City Capital
agreed to waive all accrued interest on the $36.9 million of convertible notes issued by Madrigal to Bay City Capital pursuant to (i) a note purchase agreement dated September 16,
2011 and (ii) an assignment and issuance agreement dated September 14, 2011, which we refer to as the old notes, through the date of the 2016 purchase agreement. Bay City Capital also
agreed that no interest will accrue on the old notes from the date of the 2016 purchase agreement through the date on which either the merger is consummated or the Merger Agreement is terminated. The
other investor parties to the 2016 purchase agreement also agreed that no interest will accrue on the new notes issued thereunder from the date of the 2016 purchase agreement through the date on which
either the merger is consummated or the Merger Agreement is terminated. In addition, all of the old notes and new notes will convert into common stock of Madrigal pursuant to their terms immediately
prior to completion of the merger. The 2016 purchase agreement and accompanying new notes contain customary events of default, which, if uncured, entitle each noteholder to accelerate the due date of
the unpaid principal amount of, and all accrued and unpaid interest on, the new notes.
Voting Agreements
(see page 115)
In
connection with the execution of the Merger Agreement, certain securityholders of Madrigal entered into voting agreements with Synta and Madrigal under
which such securityholders have agreed to vote in favor of the merger and against any alternative acquisition proposal, agreement or transaction. As of May 2, 2016, these individuals and
entities own in the aggregate, approximately 100% of the voting power of Madrigal on an as-converted to common stock basis. These voting agreements grant Synta irrevocable proxies to vote or give
consent with respect to any shares of Madrigal stock over which such securityholder has voting power in favor of each of the Madrigal proposals described elsewhere in this proxy statement and against
any alternative acquisition proposal, agreement or transaction. The stockholders of Madrigal approved the merger on April 13, 2016.
In
connection with the execution of the Merger Agreement, certain stockholders of Synta, who in the aggregate, own approximately 18.2% of Synta's outstanding shares, also entered into
voting agreements with Synta and Madrigal under which such stockholder has agreed to vote in favor of the
14
Table of Contents
proposals
that relate to the merger described elsewhere in this proxy statement and against any alternative acquisition proposal, agreement or transaction. Each of these voting agreements grant
Madrigal irrevocable proxies to vote any shares of Synta common stock over which such stockholder has voting power in favor of each of the proposals described elsewhere in this proxy statement and
against any alternative acquisition proposal, agreement or transaction.
Each
stockholder executing a voting agreement has made representations and warranties to Synta and Madrigal, as applicable, regarding ownership and unencumbered title to the shares
thereto, such stockholder's power and authority to execute the voting agreement, and due execution and enforceability of the voting agreement. Unless otherwise waived, all of these voting agreements
prohibit the sale, assignment, transfer or other disposition by the stockholder of their respective shares of Synta or Madrigal stock, or the entrance into an agreement or commitment to do any of the
foregoing, except for transfers by will or by operation of law, in which case the voting agreement will bind the transferee. Each stockholder executing a voting agreement has also waived its statutory
appraisal rights in connection with the merger.
The
voting agreements will terminate at the earlier of the effective time of the merger, termination of the Merger Agreement in accordance with its terms or upon mutual written consent
of such stockholder, Synta and Madrigal.
Lock-Up Agreements
(see page 116)
As
a condition to the closing of the merger, the Madrigal securityholders who entered into voting agreements also entered into lock-up agreements, pursuant to
which the securityholders have agreed not to, except in limited circumstances, sell, assign, transfer, tender, or otherwise dispose of, any Madrigal securities and shares of Synta common stock,
including, as
applicable, shares received in the merger and issuable upon exercise of certain options, from April 13, 2016, the date the lock-up agreements were executed, until 180 days after the
closing date of the merger.
The
Madrigal securityholders who have executed lock-up agreements own in the aggregate approximately 100% of the outstanding shares of Madrigal stock on an as-converted to common stock
basis.
Management Following the Merger
(see
page 216)
Effective
as of the closing of the merger, Synta's executive officers are expected to be composed of Paul A. Friedman, M.D., serving as the Chief Executive
Officer and Chairman of the Board, Rebecca Taub, M.D., serving as the Chief Medical Officer, Executive Vice President, Research & Development, and Marc R. Schneebaum, serving as Chief Financial
Officer.
Interests of Certain Directors, Officers and Affiliates of Synta
(see pages 90 and 223)
In
considering the recommendation of the Synta board of directors with respect to issuing shares of Synta common stock pursuant to the Merger Agreement and the
other matters to be acted upon by Synta stockholders at the Annual Meeting, Synta stockholders should be aware that certain members of the Synta board of directors and named executive officers of
Synta have interests in the merger that may be different from, or in addition to, interests they have as Synta stockholders. The Synta board of directors was aware of the following interests and
considered them, among other matters, in its decision to approve the Merger Agreement.
15
Table of Contents
Additionally,
Keith R. Gollust, currently a director of Synta, will continue as a director of the combined company after the effective time of the merger.
-
-
Synta Director Paul A. Friedman's Relationship with Madrigal and the Combined Company
Dr. Friedman
has personal interests both in Madrigal and the combined company. These interests were fully disclosed to and known by the Synta board of directors and corporate governance
measures were taken to address them, including Dr. Friedman's exclusion from Synta board of director proceedings with respect to Madrigal, as described more fully in "The
MergerBackground of the Merger." These interests are:
-
-
The current Chief Executive Officer of Madrigal, Rebecca Taub, M.D. and Dr. Friedman are married.
-
-
Upon the closing of the merger, Dr. Friedman and Dr. Taub will be employed as executive officers of the
combined company as described above.
-
-
Dr. Friedman and Dr. Taub have irrevocably committed to loan approximately $5 million to Madrigal in
the form of promissory notes that will convert into 25,905,930 shares of Synta common stock as part of the merger closing.
-
-
Dr. Friedman and Dr. Taub will have significant beneficial ownership interest in the combined company due
in part to the post-closing entity's equity compensation arrangements with Dr. Friedman and Dr. Taub. Assuming the full vesting and exercise of options to purchase 14,875,669 shares of
common stock and the vesting 5,950,267 shares of restricted stock, and based on the projected number of shares of Synta common stock to be outstanding immediately after the closing,
Dr. Friedman and Dr. Taub would have a pro forma stock ownership of 60,493,023 shares of the combined company, or approximately 14.5% immediately after the closing of the merger.
-
-
Other
Upon
a termination of employment in connection with the merger, Synta's named executive officers may receive cash severance payments and other benefits with a total value of approximately
$3.2 million (collectively, not individually, and including the value of the accelerated vesting of unvested restricted stock awards and the vesting of restricted stock unit awards).
16
Table of Contents
Material U.S. Federal Income Tax Consequences of the
Merger
(see page 97)
Each
of Synta and Madrigal intends the merger to qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986,
as amended, or the Code.
Since
Synta stockholders will continue to own and hold their existing shares of Synta common stock following the merger, the merger generally will not result in U.S. federal income tax
consequences to Synta stockholders.
Synta
stockholders who are also stockholders of Madrigal should consult their tax advisor as to the tax consequences to them of participating in the merger as a Madrigal stockholder.
Risk Factors
(see page 26)
Both
Synta and Madrigal are subject to various risks associated with their businesses and their industries. In addition, the merger, including the possibility
that the merger may not be completed, poses a number of risks to each company and its respective stockholders, including the following risks:
-
-
the market price of Synta common stock following the completion of the merger may decline as a result of the transaction;
-
-
the anticipated benefits of the merger may not be realized;
-
-
synta stockholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the
combined company following the completion of the merger;
-
-
synta stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in
connection with the merger;
-
-
failure to complete the merger may adversely affect the common stock price of Synta and future business and operations of Synta and
Madrigal;
-
-
during the pendency of the merger, Synta and Madrigal may not be able to enter into a business combination with another party at a
favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses;
-
-
provisions of the Merger Agreement may discourage third parties from submitting alternative acquisition proposals, including proposals
that may be superior to the merger;
-
-
the lack of a public market for Madrigal shares makes it difficult to determine the fair value of Madrigal, and the merger
consideration to be issued to Madrigal securityholders may exceed the actual value of Madrigal;
-
-
synta and Madrigal will incur substantial transaction-related costs in connection with the merger;
-
-
a failure by Synta to comply with the continued and initial listing standards of The NASDAQ Global Market or The NASDAQ Capital Market
may subject its stock to delisting from The NASDAQ Stock Market, which listing is a condition to the completion of the merger;
-
-
synta and Madrigal may become involved in securities class action litigation or shareholder derivative litigation that could divert
management's attention and harm the combined company's business and insurance coverage may not be sufficient to cover all costs and damages;
-
-
synta may not be able to complete the merger and may elect to pursue another strategic transaction similar to the merger, which may
not occur on commercially reasonably terms or at all;
17
Table of Contents
-
-
if the merger is not completed, Synta may elect to liquidate its remaining assets, and there can be no assurances as to the amount of
cash available to distribute to stockholders after paying its debts and other obligations; and
-
-
if the merger is not completed, and Synta fails to advance STA-12-8666 or acquire or develop other products or product candidates on
commercially reasonable terms, or at all, Synta may be unable to conduct a viable operating business.
These
risks and other risks are discussed in greater detail under the section entitled "Risk Factors" beginning on page 26. Synta and Madrigal both encourage you to read and
consider all of these risks carefully.
Regulatory Approvals
(see
page 109)
Synta
must comply with applicable federal and state securities laws and the rules and regulations of The NASDAQ Stock Market in connection with the issuance of
shares of Synta common stock and the filing of this proxy statement with the SEC.
NASDAQ Stock Market Listing
(see pages 97
and 110)
Synta
has filed an initial listing application with The NASDAQ Global Market or The NASDAQ Capital Market pursuant to The NASDAQ Stock Market's "change of
control" rules. If such application is accepted, Synta anticipates that Synta's common stock will be listed on The NASDAQ Global Market or The NASDAQ Capital Market following the closing of the merger
under the trading symbol "MDGL."
Anticipated Accounting Treatment
(see
page 98)
Synta
currently expects to treat the merger as a purchase by Madrigal of Synta under accounting principles generally accepted in the United States, or GAAP.
Under the purchase method of accounting, the assets and liabilities of Synta will be recorded, as of the completion of the merger, at their respective fair values, in the financial statements of
Madrigal. The financial statements of Madrigal issued after the completion of the merger will reflect these values, but will not be restated retroactively to reflect the historical financial position
or results of operations of Synta.
Appraisal Rights and Dissenters' Rights
Holders of Synta common stock are not entitled to appraisal rights in connection with the merger.
18
Table of Contents
SELECTED HISTORICAL AND UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL DATA
The following tables present summary historical financial data for Synta and Madrigal, summary unaudited pro
forma condensed combined financial data for Synta and Madrigal, and comparative historical and unaudited pro forma per share data for Synta and Madrigal. The following tables do not give effect to the
proposed reverse stock split described in Proposal No. 2 of this proxy statement.
Selected Historical Financial Data of Synta
The following table summarizes Synta's consolidated financial data as of the dates and for each of the periods indicated. The selected
financial data as of December 31, 2015 and 2014 and for the years ended December 31, 2015, 2014 and 2013 are derived from the Synta audited consolidated financial statements and notes
thereto appearing in Synta's Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 15, 2016 and amended April 29, 2016, or the
Synta 10-K, which is incorporated by reference in this proxy statement. The selected financial data as of December 31, 2013, 2012, and 2011 and for the years ended December 31,
2012 and 2011 are derived from Synta's audited consolidated financial statements for the respective periods, which are not included or incorporated by reference in this proxy statement. The selected
financial data as of March 31, 2016 and for the three months ended March 31, 2016 and 2015 are derived from the Synta unaudited financial statements and related notes appearing in
Synta's Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the SEC on May 10, 2016, or the Synta 10-Q, which is incorporated by reference in this proxy
statement. This financial data should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the financial statements and notes thereto
appearing in the Synta 10-K and the Synta 10-Q. Synta's historical results are not necessarily indicative of the results that may be expected in the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31
|
|
Three Months Ended
March 31,
|
|
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2016
|
|
2015
|
|
|
|
(in thousands, except per share data)
|
|
|
|
|
|
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone revenue(1)
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
6,731
|
|
$
|
|
|
$
|
|
|
Grant revenue
|
|
|
|
|
|
|
|
|
|
|
|
147
|
|
|
853
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
|
|
|
|
|
|
147
|
|
|
7,584
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
54,218
|
|
|
68,205
|
|
|
71,860
|
|
|
49,412
|
|
|
41,464
|
|
|
3,407
|
|
|
16,182
|
|
General and administrative
|
|
|
13,392
|
|
|
15,746
|
|
|
15,699
|
|
|
11,676
|
|
|
11,552
|
|
|
3,040
|
|
|
4,150
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
67,610
|
|
|
83,951
|
|
|
87,559
|
|
|
61,088
|
|
|
53,016
|
|
|
6,447
|
|
|
20,332
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(67,610
|
)
|
|
(83,951
|
)
|
|
(87,559
|
)
|
|
(60,941
|
)
|
|
(45,432
|
)
|
|
(6,447
|
)
|
|
(20,332
|
)
|
Other expense, net
|
|
|
(1,061
|
)
|
|
(2,210
|
)
|
|
(2,633
|
)
|
|
(1,849
|
)
|
|
(1,948
|
)
|
|
(77
|
)
|
|
(375
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(68,671
|
)
|
$
|
(86,161
|
)
|
$
|
(90,192
|
)
|
$
|
(62,790
|
)
|
$
|
(47,380
|
)
|
|
(6,524
|
)
|
|
(20,707
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$
|
(0.53
|
)
|
$
|
(0.87
|
)
|
$
|
(1.27
|
)
|
$
|
(1.06
|
)
|
$
|
(1.00
|
)
|
$
|
(0.05
|
)
|
$
|
(0.19
|
)
|
Basic and diluted weighted average number common shares outstanding
|
|
|
128,595
|
|
|
98,489
|
|
|
70,977
|
|
|
59,411
|
|
|
47,198
|
|
|
137,362
|
|
|
108,376
|
|
-
(1)
-
In
December 2008, Synta entered into an agreement with Hoffman-La Roche, or Roche, for its CRACM inhibitor program. Roche provided written notification of
termination in November 2011,
19
Table of Contents
resulting
in accelerated recognition of $2.1 million of previously deferred revenue in the fourth quarter of 2011.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
Three Months
Ended
March 31,
2016
|
|
|
|
Year ended December 31,
|
|
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
|
|
(in thousands)
|
|
|
|
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
66,574
|
|
$
|
97,690
|
|
$
|
91,476
|
|
$
|
100,599
|
|
$
|
39,725
|
|
$
|
52,042
|
|
Working capital
|
|
|
49,987
|
|
|
68,457
|
|
|
60,034
|
|
|
77,899
|
|
|
25,138
|
|
|
43,957
|
|
Total assets
|
|
|
68,195
|
|
|
100,675
|
|
|
95,203
|
|
|
103,017
|
|
|
42,324
|
|
|
52,970
|
|
Capital lease obligations, net of current portion
|
|
|
|
|
|
43
|
|
|
85
|
|
|
1
|
|
|
14
|
|
|
33
|
|
Term loans, current portion
|
|
|
4,607
|
|
|
9,214
|
|
|
9,451
|
|
|
7,924
|
|
|
4,234
|
|
|
2,299
|
|
Term loans, net of current portion
|
|
|
|
|
|
4,607
|
|
|
13,820
|
|
|
4,464
|
|
|
12,388
|
|
|
|
|
Common stock and additional paid-in capital
|
|
|
756,647
|
|
|
702,705
|
|
|
600,486
|
|
|
536,284
|
|
|
413,201
|
|
|
757,095
|
|
Accumulated deficit
|
|
|
(706,244
|
)
|
|
(637,573
|
)
|
|
(551,412
|
)
|
|
(461,220
|
)
|
|
(398,430
|
)
|
|
(712,768
|
)
|
Total stockholders' equity
|
|
|
50,407
|
|
|
65,136
|
|
|
49,091
|
|
|
75,066
|
|
|
14,774
|
|
|
44,331
|
|
Selected Historical Financial Data of Madrigal
The following table summarizes Madrigal's selected financial data as of the dates and periods indicated. The selected financial data as
of December 31, 2015 and 2014 and for the years ended December 31, 2015 and 2014 are derived from the Madrigal audited financial statements prepared using GAAP, which are included in
this proxy statement. The audit report on the financial statements for the years ended December 31, 2015 and 2014, which appears elsewhere herein, includes an explanatory paragraph related to
Madrigal's ability to continue as a going concern. The selected financial data as of March 31, 2016 and for the three months ended March 31, 2016 and 2015 are derived from Madrigal's
unaudited financial statements and related notes, which are included in this proxy statement. The financial data should be read in conjunction with "Madrigal Management's Discussion and Analysis of
Financial Condition and Results of Operations" beginning on page 206 and
20
Table of Contents
the
Madrigal financial statements and related notes appearing elsewhere in this proxy statement. The historical results are not necessarily indicative of results to be expected in any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended March 31,
|
|
Year Ended
December 31,
|
|
|
|
2016
|
|
2015
|
|
2015
|
|
2014
|
|
|
|
(In thousands,
except per share
data)
|
|
|
|
|
|
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
516
|
|
$
|
344
|
|
$
|
2,427
|
|
$
|
777
|
|
General and administrative
|
|
|
222
|
|
|
196
|
|
|
806
|
|
|
548
|
|
Loss from operation
|
|
|
(738
|
)
|
|
(540
|
)
|
|
(3,233
|
)
|
|
(1,326
|
)
|
Interest expense, net
|
|
|
(975
|
)
|
|
(843
|
)
|
|
(3,612
|
)
|
|
(3,166
|
)
|
Net loss
|
|
$
|
(1,713
|
)
|
$
|
(1,382
|
)
|
$
|
(6,845
|
)
|
$
|
(4,492
|
)
|
Basic and diluted net loss per common share
|
|
$
|
(1.55
|
)
|
$
|
(1.28
|
)
|
$
|
(6.38
|
)
|
$
|
(4.30
|
)
|
Basic and diluted weighted average number of common shares outstanding
|
|
|
1,106
|
|
|
1,080
|
|
|
1,073
|
|
|
1,045
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
Three Months
Ended
March 31,
2016
|
|
Year Ended
December 31,
|
|
|
|
2015
|
|
2014
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
618
|
|
$
|
306
|
|
$
|
148
|
|
Total assets
|
|
|
770
|
|
|
364
|
|
|
194
|
|
Convertible promissory notes payablerelated party
|
|
|
50,315
|
|
|
48,595
|
|
|
42,193
|
|
Total liabilities
|
|
|
51,396
|
|
|
49,277
|
|
|
42,263
|
|
Accumulated deficit
|
|
|
(50,632
|
)
|
|
(48,920
|
)
|
|
(42,069
|
)
|
Total stockholders' deficit
|
|
|
(50,626
|
)
|
|
(48,913
|
)
|
|
(42,069
|
)
|
Selected Unaudited Pro Forma Condensed Combined Financial Data of Synta and Madrigal
The following selected unaudited pro forma condensed combined financial data is intended to show how the merger might have affected
historical financial statements. Synta and Madrigal unaudited pro forma condensed combined balance sheet data assume that the merger took place on March 31, 2016 and combine the Synta and
Madrigal historical balance sheets at March 31, 2016. Synta and Madrigal unaudited pro forma condensed combined statement of operations data assume that the merger took place on each of
January 1, 2016 and January 1, 2015, and combine the historical results of Synta and Madrigal for the three months ended March 31, 2016 and the year ended December 31,
2015. The following should be read in conjunction with the section entitled "Unaudited Pro Forma Condensed Combined Financial Statements" beginning on page 227, Synta's audited financial statements
and notes thereto included in the Synta 10-K, Synta's unaudited financial statements and notes thereto included in the Synta 10-Q, Madrigal's audited and unaudited historical financial statements and
the notes thereto beginning on page F-1, the sections entitled "Synta Management's Discussion and Analysis of Financial Condition and Results of Operations" beginning on page 203 and "Madrigal
Management's Discussion and Analysis of Financial Condition and Results of Operations" beginning on page 206 and the other information contained in this proxy statement. The following information does
not give effect to the proposed reverse stock split of Synta common stock described in Proposal No. 2.
21
Table of Contents
The
unaudited pro forma condensed combined financial statements were prepared in accordance with the regulations of the SEC. The pro forma adjustments reflecting the completion of the
merger are based upon the application of the acquisition method of accounting in accordance with GAAP and upon the assumptions set forth in the unaudited pro forma condensed combined financial
statements.
The
historical financial data has been adjusted to give pro forma effect to events that are (i) directly attributable to the merger, (ii) factually supportable and
(iii) with respect to the statements of
operations, expected to have a continuing impact on the combined results. The pro forma adjustments are preliminary and based on management's estimates of the fair value and useful lives of the assets
acquired and liabilities assumed and have been prepared to illustrate the estimated effect of the acquisition and certain other adjustments.
The
unaudited pro forma condensed combined financial data is presented for illustrative purposes only and is not necessarily indicative of the financial condition or results of
operations of future periods or the financial condition or results of operations that actually would have been realized had the entities been combined during the periods presented. In addition, as
explained in more detail in the accompanying notes to the unaudited pro forma condensed combined financial statements (see the section entitled "Unaudited Pro Forma Condensed Combined Financial
Statements" beginning on page 227), the preliminary acquisition-date fair value of the identifiable assets acquired and liabilities assumed reflected in the unaudited pro forma condensed
combined financial statements is subject to adjustment and may vary from the actual amounts that will be recorded upon completion of the merger.
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
2016
|
|
Year Ended
December 31,
2015
|
|
|
|
(in thousands except
per share amounts)
|
|
Unaudited Pro Forma Condensed Combined Statements of Operations Data:
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
|
4,137
|
|
|
57,501
|
|
General and administrative
|
|
|
3,230
|
|
|
15,958
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
7,367
|
|
|
73,459
|
|
Net loss
|
|
$
|
(7,444
|
)
|
$
|
(74,520
|
)
|
Basic and diluted net loss per share
|
|
$
|
(0.02
|
)
|
$
|
(0.19
|
)
|
|
|
|
|
|
|
|
As of
March 31,
2016
|
|
|
|
(In thousands)
|
|
Unaudited Pro Forma Condensed Combined Balance Sheet Data:
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
60,410
|
|
Working capital
|
|
|
45,582
|
|
Total assets
|
|
|
79,161
|
|
Term loans and capital lease obligations
|
|
|
2,332
|
|
Accumulated Deficit
|
|
|
(50,818
|
)
|
Stockholders' equity
|
|
|
63,627
|
|
Comparative Historical and Unaudited Pro Forma Per Share Data
The information below reflects the historical net loss and book value per share of Synta common stock and the historical net loss and
book value per share of Madrigal common stock in comparison
22
Table of Contents
with
the unaudited pro forma net loss and book value per share after giving effect to the merger of Synta with Madrigal. The unaudited pro forma net loss and book value per share does not give effect
to the proposed reverse stock split of Synta common stock described in Proposal No. 2.
You
should read the tables below in conjunction with the audited and unaudited financial statements of Synta incorporated by reference in this proxy statement and the audited and
unaudited financial statements of Madrigal included elsewhere in this proxy statement and the related notes and the unaudited pro forma condensed combined financial information and notes related to
such financial statements included elsewhere in this proxy statement.
SYNTA
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
2016
|
|
Year Ended
December 31,
2015
|
|
Historical Per Common Share Data:
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.05
|
)
|
$
|
(0.53
|
)
|
Book value per share
|
|
|
0.32
|
|
|
0.37
|
|
MADRIGAL
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
2016
|
|
Year Ended
December 31,
2015
|
|
Historical Per Common Share Data:
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(1.55
|
)
|
$
|
(6.38
|
)
|
Book value per share
|
|
|
(45.78
|
)
|
|
(44.23
|
)
|
SYNTA AND MADRIGAL
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
2016
|
|
Year Ended
December 31,
2015
|
|
Historical Per Common Share Data:
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.02
|
)
|
$
|
(0.19
|
)
|
Book value per share
|
|
|
0.16
|
|
|
|
|
23
Table of Contents
MARKET PRICE AND DIVIDEND INFORMATION
On June 2, 2016, Synta received approval from The NASDAQ Stock Market to transfer its listing from The NASDAQ Global Market to
The NASDAQ Capital Market effective as of June 3, 2016. Synta common stock is currently listed on The NASDAQ Capital Market under the symbol "SNTA." The following table presents, for the
periods indicated, the range of high and low per share sales prices for Synta common stock as reported on The NASDAQ Global Market for each of the periods set forth below. Madrigal is a private
company and its common stock is not publicly traded. These per share sales prices do not give effect to the proposed reverse stock split of Synta common stock to be implemented prior to the closing of
the merger.
Synta Common Stock
|
|
|
|
|
|
|
|
|
|
High
|
|
Low
|
|
Year Ended December 31, 2014
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
7.22
|
|
$
|
4.07
|
|
Second Quarter
|
|
$
|
4.60
|
|
$
|
3.91
|
|
Third Quarter
|
|
$
|
4.97
|
|
$
|
2.94
|
|
Fourth Quarter
|
|
$
|
3.44
|
|
$
|
2.54
|
|
Year Ended December 31, 2015
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
2.98
|
|
$
|
1.85
|
|
Second Quarter
|
|
$
|
3.17
|
|
$
|
1.91
|
|
Third Quarter
|
|
$
|
2.37
|
|
$
|
1.57
|
|
Fourth Quarter
|
|
$
|
2.08
|
|
$
|
0.29
|
|
Year Ended December 31, 2016
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
0.36
|
|
$
|
0.15
|
|
Second Quarter (until June 2, 2016)
|
|
$
|
0.45
|
|
$
|
0.23
|
|
The
closing price of Synta common stock on April 13, 2016, the last trading day prior to the public announcement of the merger, was $0.24 per share and the closing price of Synta
common stock on April 14, 2016 was $0.41 per share, in each case as reported on The NASDAQ Global Market.
Because
the market price of Synta common stock is subject to fluctuation, the market value of the shares of Synta common stock that Madrigal stockholders will be entitled to receive in
the merger may increase or decrease.
Assuming
successful application for initial listing with The NASDAQ Global Market or The NASDAQ Capital Market, following the completion of the merger, Synta common stock will be listed
on The NASDAQ Global Market or The NASDAQ Capital Market and will trade under Synta's new name, "Madrigal Pharmaceuticals, Inc.," and new trading symbol "MDGL."
As
of May 31, 2016, the record date for the Annual Meeting, Synta had approximately 39 holders of record of its common stock. As of May 31, 2016, Madrigal had three
holders of record of its common stock.
Dividends
Synta has never paid or declared any cash dividends on its common stock and Synta is currently prohibited from making any dividend
payment under the terms of the Merger Agreement. Synta currently intends to retain all available funds and any future earnings to fund the development and expansion of its business, and Synta does not
anticipate paying any cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of Synta's board of directors and will depend on Synta's financial
condition, results of operations, contractual restrictions, capital requirements, and other factors that Synta's board of directors deems relevant.
24
Table of Contents
Madrigal
has never paid or declared any cash dividends on its common stock. If the merger does not occur, Madrigal does not anticipate paying any cash dividends on its common stock in
the foreseeable future, and Madrigal intends to retain all available funds and any future earnings to fund the development and expansion of its business. Any future determination to pay dividends will
be at the discretion of Madrigal's board of directors and will depended upon a number of factors, including its results of operations, financial condition, prospects, contractual restrictions,
restrictions imposed by applicable law and other factors Madrigal's then-current board of directors deems relevant.
25
Table of Contents
RISK FACTORS
The combined company will be faced with a market environment that cannot be predicted and that involves
significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement, you should carefully consider the material risks described below
before deciding how to vote your shares of Synta common stock. In addition, you should read and consider the risks associated with the business of Synta because these risks may also affect the
combined companythese risks can be found in Synta's 10-K, as updated by Synta's 10-Q, both of which are filed with the SEC. You should also read and consider the other information in this
proxy statement and the other documents incorporated by reference into this proxy statement. Please see the section entitled "Where You Can Find More Information" on page 247 in this proxy
statement.
Risks Related to the Merger
The number of shares that Madrigal securityholders will receive is not adjustable based on the
market price of Synta common stock, so the merger consideration at the closing may have a greater or lesser value than the market price at the time the Merger Agreement was signed.
The Merger Agreement has set the exchange ratio formula for Madrigal common stock, subject to adjustment based on the proposed reverse
stock split to be implemented prior to the closing of the merger. Any changes in the market price of Synta common stock before the completion of the merger will not affect the number of shares
Madrigal securityholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the merger the market price of Synta common stock declines from the market
price on the date of the Merger Agreement, then Madrigal securityholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the merger, the
market price of Synta common stock increases from the market price on the date of the Merger Agreement, then Madrigal securityholders could receive merger consideration with substantially more value
for their shares of Madrigal capital stock than the parties had negotiated for in the establishment of the exchange ratio. The Merger Agreement does not include a price-based termination right.
The announcement and pendency of the merger could have an adverse effect on Synta's business,
financial condition, results of operations, or business prospects.
While there have been no significant adverse effects to date, the announcement and pendency of the merger could disrupt Synta's
businesses in the following ways, among others:
-
-
third parties may seek to terminate and/or renegotiate their relationships with Synta as a result of the merger, whether pursuant to
the terms of their existing agreements with Synta or otherwise; and
-
-
the attention of Synta's management may be directed toward the completion of the merger and related matters and may be diverted from
the day-to-day business operations of Synta, including from other opportunities that might otherwise be beneficial to Synta.
Should
they occur, any of these matters could adversely affect Synta's financial condition, results of operations, or business prospects.
The market price of Synta's common stock following the merger may decline as a result of the
transaction.
The market price of Synta's common stock may decline as a result of the merger for a number of reasons, including
if:
-
-
investors react negatively to the combined company's business and prospects; or
26
Table of Contents
-
-
the performance of the combined company's business or its prospects are not consistent with the expectations of financial or industry
analysts.
Even if the merger is consummated, Synta and Madrigal may fail to realize the anticipated benefits
of the merger.
The success of the merger will depend on, among other things, the combined company's ability to achieve its business objectives,
including the successful development of its product candidates. If the combined company is not able to achieve these objectives, the anticipated benefits of the merger may not be realized fully, may
take longer to realize than expected, or may not be realized at all.
Synta
and Madrigal have operated and, until the completion of the merger, will continue to operate independently. Following the completion of the merger, it is possible that the
integration process could result in the loss of key employees, the disruption of each company's ongoing business, an adverse impact on the value of its assets, or inconsistencies in standards,
controls, procedures or policies that could adversely affect Synta's ability to comply with reporting obligations as a public company, to satisfy its obligations to third parties or to achieve the
anticipated benefits of the merger. Integration efforts between the two companies will also divert management's attention and resources. Any delays in the integration process or inability to realize
the full extent of the anticipated benefits of the merger could have an adverse effect on Synta's business and the results of its operations. Such an adverse effect on the business may affect the
value of the shares of the combined company's common stock after the completion of the merger.
Potential
difficulties that may be encountered in the integration process include the following:
-
-
using the combined company's cash and other assets efficiently to develop the business of the combined company;
-
-
appropriately managing the liabilities of the combined company;
-
-
potential unknown or currently unquantifiable liabilities associated with the merger and the operations of the combined company; and
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-
performance shortfalls at one or both of the companies as a result of the diversion of management's attention caused by completing the
merger and integrating the companies' operations.
In
addition, Madrigal could be materially adversely affected prior to the closing of the merger, which could have a material adverse effect on the combined company if Synta is required
to complete the merger. For example, Synta is required under the Merger Agreement to complete the merger despite any changes in general economic or political conditions or the securities market in
general, to the extent they do not disproportionately affect Madrigal; any changes in or affecting the industries in which Madrigal operates, to the extent they do not disproportionately affect
Madrigal in any material respect; any changes, effects or circumstances resulting from the announcement or pendency of the Merger Agreement or the completion of the contemplated transactions or
compliance with the terms of the Merger Agreement; and continued losses from operations or decreases in cash balances of Madrigal. If any such adverse changes occur and the merger is still completed,
the combined company's stock price may suffer. This in turn may reduce the value of the merger to Synta's stockholders.
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Some Synta executive officers and directors have interests in the merger that are different from, or
in addition to, yours and that may influence them to support or approve the issuance of shares of Synta common stock in connection with the merger and the related matters to be acted upon by Synta's
stockholders at the Annual Meeting.
Certain executive officers and directors of Synta participate in arrangements that provide them with interests in the merger that are
different from, or in addition to, yours, including, among others, affiliate ownership of equity in Madrigal, the continued service as an executive officer or director of the combined company,
severance benefits, the acceleration of stock options restricted stock and restricted stock unit vesting and continued indemnification.
For
example, Synta has entered into certain employment and severance benefits agreements with each of its named executive officers that may result in the receipt by such named executive
officers of cash severance payments and other benefits with a total value of approximately $3.2 million (collectively, not individually, and including the value of the accelerated vesting of
unvested restricted stock awards and the vesting of restricted stock units awards), based on data available as of May 2, 2016, the latest practicable date prior to the filing of this proxy
statement, and assuming a covered termination of employment of each named executive officer's employment as of such date. The closing of the merger
will also result in the vesting of 3,300,000 restricted stock unit awards, whether or not there is a covered termination of such named executive officer's employment. The value of these awards is
included in the total value of cash severance payments and other benefits described above.
By
way of further example, at the effective time of the merger, the officers of the combined company will include Paul A. Friedman, M.D., former director of Synta, who will be the Chief
Executive Officer and Chairman of the combined company, and Rebecca Taub, M.D., a current executive officer of Madrigal who will be the Chief Medical Officer, Executive Vice President,
Research & Development and Director, of the combined company. Dr. Friedman is the spouse of Dr. Taub. Dr. Friedman and Dr. Taub will have significant beneficial
ownership interests in the combined company due in part to the post-closing entity's equity compensation arrangements with Dr. Friedman and Dr. Taub. Assuming the full vesting and
exercise of options to purchase 14,875,669 shares of common stock and the vesting 5,950,267 shares of restricted stock, and based on the projected number of shares of Synta common stock to be
outstanding immediately after the closing, Dr. Friedman and Dr. Taub would have a pro forma stock ownership of 60,493,023 shares of the combined company, or approximately 14.5%
immediately after the closing of the merger. Additionally, Marc R. Schneebaum is currently the Chief Financial Officer of Synta and will continue as the Chief Financial Officer of the combined
company after the effective time of the merger and Keith R. Gollust is currently a director of Synta and will continue as a director of the combined company after the effective time of the
merger. As further discussed under the heading "Background of the Merger," Dr. Friedman was excluded from certain discussions of Synta's board of directors involving its consideration of the
potential merger with Madrigal and was excluded at the time Synta's board of directors voted in favor of the transaction contemplated by the Merger Agreement.
These
interests, among others, may have influenced or may influence the officers and directors of Synta to support or approve the issuance of shares of Synta common stock in connection
with the merger and the related matters to be acted upon by Synta's stockholders at the Annual Meeting. For more information concerning the interests of Synta executive officers and directors, see the
section entitled "The MergerInterests of the Synta Directors and Executive Officers in the Merger" beginning on page 90 of this proxy statement.
Synta's stockholders will have a reduced ownership and voting interest in, and will exercise less
influence over the management of, the combined company following the completion of the merger.
After the completion of the merger, the current stockholders of Synta will own a significantly smaller percentage of the combined
company than their ownership of Synta prior to the merger. At the
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effective
time of the merger, Synta's equityholders will collectively own approximately 36% of the outstanding shares of the combined company, assuming no future, unanticipated issuances of Synta or
Madrigal capital stock prior to closing of the merger. This calculation does not contemplate outstanding Synta option awards, which will remain outstanding under their existing terms following the
merger, nor does it include equity awards in the amount of 20,825,936 shares of common stock of the combined company that are expected to be granted immediately after the completion of the merger to
Paul A. Friedman, M.D., and Rebecca Taub, M.D., as executive officers of the combined company. In addition, the seven-member board of directors of the combined company will initially be comprised of
five Madrigal directors, one current Synta director and one additional director mutually agreed to by Synta and Madrigal. Consequently, Synta's stockholders will be able to exercise less influence
over the management and policies of the combined company than they currently exercise over the management and policies of Synta.
Synta's stockholders may not realize a benefit from the merger commensurate with the ownership
dilution they will experience in connection with the merger.
If the combined company is unable to realize the full strategic and financial benefits anticipated from the merger, Synta's
stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the
combined company is able to realize only part of the strategic and financial benefits currently anticipated from the merger.
Failure to complete the merger may adversely affect Synta's common stock price and future business
and operations.
If the merger is not completed, Synta is subject to the following risks:
-
-
if the Merger Agreement is terminated under certain circumstances, Synta will be required to pay Madrigal a termination fee of
$1.25 million, or to reimburse Madrigal for up to $250,000 in certain transaction expenses;
-
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the attention of Synta's management will have been diverted to the merger instead of being directed solely to Synta's own operations
and the pursuit of other opportunities that may have been beneficial to Synta;
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the loss of Synta's time and resources;
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the price of Synta's stock may decline and remain volatile; and
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costs related to the merger, such as legal, accounting and transaction agent fees, some of which must be paid even if the merger is
not completed.
In
addition, if the Merger Agreement is terminated and Synta's board of directors determines to seek another business combination, there can be no assurance that Synta will be able to
find a transaction that is superior or equal in value to the merger.
The conditions under the Merger Agreement to Madrigal's consummation of the merger may not be
satisfied at all or in the anticipated timeframe.
The obligation of Madrigal to complete the merger is subject to certain conditions, including the approval by Synta's stockholders of
certain matters and other customary closing conditions, including, among other things, the accuracy of the representations and warranties contained in the Merger Agreement, subject to certain
materiality qualifications, compliance by the parties with their respective covenants under the Merger Agreement and no law or order preventing the merger and related transactions. Synta also intends
to pursue all required approvals in accordance with the Merger Agreement. However, no assurance can be given that the required approvals will be obtained and, even
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if
all such approvals are obtained, no assurance can be given as to the terms, conditions and timing of the approvals or that they will satisfy the terms of the Merger Agreement.
During the pendency of the merger, Synta may not be able to enter into a business combination with
another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their businesses.
Covenants in the Merger Agreement generally prohibit Synta and Madrigal from entering into certain extraordinary transactions with any
third party, including mergers, purchases or sales of assets, or other business combinations, subject to certain exceptions relating to fiduciary duties, or from completing other transactions that are
not in the ordinary course of business pending completion of the merger, including transactions that may be favorable to the companies or their stockholders. As a result, if the merger is not
completed, Synta's stockholders may be adversely affected by its inability to pursue other beneficial opportunities during the pendency of the merger.
Provisions of the Merger Agreement may discourage third parties from submitting alternative
acquisition proposals, including proposals that may be superior to the merger.
The terms of the Merger Agreement prohibit Synta from soliciting alternative takeover proposals or cooperating with persons making
unsolicited takeover proposals, except in limited circumstances when its board of directors determines in good faith, after consultation with its outside legal counsel and financial advisors, that an
unsolicited bona fide written competing proposal constitutes, or would reasonably be expected to lead to, a superior competing proposal, and that failure to pursue such proposal would be considered a
breach of the board's fiduciary duties. If Synta terminates the Merger Agreement because it enters into an alternative superior transaction, Synta would be required to pay a termination fee of
$1.25 million to Madrigal. Such termination fee may discourage third parties from submitting competing takeover proposals to Synta, and may cause the board of directors to be less inclined to
recommend a competing proposal.
The lack of a public market for Madrigal shares makes it difficult to determine the fair market
value of Madrigal, and the merger consideration to be issued to Madrigal securityholders may exceed the actual value of Madrigal.
The outstanding capital stock of Madrigal is privately held and is not traded on any public market, which makes it difficult to
determine the fair market value of Madrigal. There can be no assurances that the merger consideration to be issued to Madrigal securityholders will not exceed the actual value of Madrigal.
Synta and the combined company will incur substantial transaction-related costs in connection with
the merger.
Synta has incurred, and expects to continue to incur, a number of non-recurring transaction-related costs associated with completing
the merger and combining the two companies. These fees and costs have been, and will continue to be, substantial. Non-recurring transaction costs include, but are not limited to, fees paid to legal,
financial and accounting advisors, severance and benefit costs, filing fees and printing costs. Additional unanticipated costs may be incurred in the integration of Synta's business with Madrigal's
business, which may be higher than expected and could have a material adverse effect on the combined company's financial condition and operating results.
A failure by the combined company upon the completion of the merger to comply with the initial
listing standards of The NASDAQ Global Market or The NASDAQ Capital Market may subject its stock to delisting from The NASDAQ Stock Market.
Upon completion of the merger, Synta will be required to meet the initial listing requirements to maintain the listing and continued
trading of its shares on The NASDAQ Global Market or The
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NASDAQ
Capital Market. These initial listing requirements are more difficult to achieve than the continued listing requirements under which Synta is now trading. Based on information currently
available to Synta, Synta anticipates that its stock will be unable to meet the $4.00 minimum bid price initial listing requirement at the closing of the merger unless it effects a reverse stock
split. If Synta is unable to satisfy these requirements, The NASDAQ Stock Market may notify Synta that its stock will be subject to delisting from The NASDAQ Capital Market. Pursuant to the Merger
Agreement, Synta agreed to use its commercially reasonable efforts to cause the shares of Synta common stock being issued in the merger to be approved for listing on The NASDAQ Global Market (or such
other NASDAQ market which Synta's common stock then trades) at or prior to the effective time of the merger. Madrigal agreed to use its commercially reasonable efforts to provide the information
required for an initial listing application pursuant to NASDAQ Stock Market Rule 5110 and to fully cooperate and participate in preparing such application and obtaining such listing. In
addition, often times a reverse stock split will not result in a trading price for the affected common stock that is proportional to the ratio of the split. Synta believes that the proposed reverse
stock split will be in the best interest of the combined company and its stockholders. However, Synta cannot assure you that the implementation of the reverse stock split will have a positive impact
on the price of its common stock.
The shares of Synta common stock issuable in the merger constitute restricted securities under
federal securities laws and are subject to additional restrictions on transfer. As a result, the shares will not be freely tradable following the merger, and stockholders receiving them may never be
able to achieve liquidity.
The shares of Synta common stock issued as consideration in the merger will not immediately be registered under the Securities Act. The
shares of Synta common stock will constitute "restricted stock" under the Securities Act and, therefore, such shares may not be sold unless the shares are registered or unless an exemption from the
registration and prospectus delivery requirements of the Securities Act is available. As a general matter, holders of such shares will not be able to transfer any of their shares until at least six
months after receiving shares of Synta common stock, which is when the shares would first be eligible to be sold under Rule 144 promulgated under the Securities Act, assuming the conditions
thereof are otherwise satisfied.
Pursuant
to the Merger Agreement, within 60 days of the closing date of the merger, Synta is obligated to file with the SEC a registration statement on Form S-3 (or if
Form S-3 is not available, such other form as may provide for a resale of the shares of Synta common stock issued pursuant to the merger), covering the resale of the shares of Synta common
stock received in exchange for shares of Madrigal capital stock pursuant to the merger. Synta is also obligated to use commercially reasonable efforts to cause such registration statement to be
declared effective as soon as possible following the filing of the registration statement and remain effective.
Stockholders
receiving such Synta shares in the merger will not be able to achieve liquidity with respect to their shares of Synta common stock until the time that a registration
statement covering the resale of such shares is declared effective and, as a result, holders of such shares may be required to bear the financial risks of this investment until that time.
The success of the proposed business combination of Synta and Madrigal will depend in part on
relationships with third parties, which relationships may be affected by third-party preferences or public attitudes about the merger. Any adverse changes in these relationships could adversely affect
Synta's or Madrigal's business, financial condition, or results of operations.
The success of the merger will be in part dependent on the combined entity's ability to maintain and renew the business relationships
of both Synta and Madrigal and to establish new business relationships. There can be no assurance that the management of either Synta or Madrigal will be able to maintain such business relationships,
or enter into or maintain new business contracts and other business relationships, on acceptable terms, if at all. The failure to maintain important business
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relationships
could have a material adverse effect on the business, financial condition, or results of operations of Synta and Madrigal.
Synta or the combined company may become involved in securities class action litigation that could
divert management's attention and harm the combined company's business, and insurance coverage may not be sufficient to cover all costs and damages.
In the past, securities class action or shareholder derivative litigation often follows certain significant business transactions, such
as the sale of a business division or announcement of a merger. The combined company may become involved in this type of litigation in the future. Litigation often is expensive and diverts
management's attention and resources, which could adversely affect the combined company's business.
Risks Related to the Proposed Reverse Stock Split
The reverse stock split may not increase the combined company's stock price over the long-term.
The principal purpose of the reverse stock split is to increase the per-share market price of Synta's common stock. It cannot be
assured, however, that the reverse stock split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of common
stock will proportionally increase the market price of Synta's common stock, it cannot be assured that the reverse stock split will increase the market price of its common stock by a multiple of the
proposed reverse stock split ratio, or result in any permanent or sustained increase in the market price of Synta's common stock, which is dependent upon many factors, including the combined company's
business and financial performance, general market conditions, and prospects for future success. Thus, while the stock price of the combined company might meet the continued listing requirements for
The NASDAQ Global Market or The NASDAQ Capital Market initially, it cannot be assured that it will continue to do so.
The reverse stock split may decrease the liquidity of the combined company's common stock.
Although the Synta board of directors believes that the anticipated increase in the market price of the combined company's common stock
could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding
after the reverse stock split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for Synta's common stock.
The reverse stock split may lead to a decrease in the combined company's overall market
capitalization.
Should the market price of the combined company's common stock decline after the reverse stock split, the percentage decline may be
greater, due to the smaller number of shares outstanding, than it would have been prior to the reverse stock split. A reverse stock split may be viewed negatively by the market and, consequently, can
lead to a decrease in the combined company's overall market capitalization. If the per share market price does not increase in proportion to the reverse stock split ratio, then the value of the
combined company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to
pre-reverse split levels, and accordingly, it cannot be assured that the total market value of Synta's common stock will remain the same after the reverse stock split is effected, or that the reverse
stock split will not have an adverse effect on Synta's stock price due to the reduced number of shares outstanding after the reverse stock split.
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Risks Related to Synta
Synta may not be able to complete the merger and may elect to pursue another strategic transaction
similar to the merger, which may not occur on commercially reasonably terms or at all.
Synta cannot assure you that it will complete the merger in a timely manner or at all. The Merger Agreement is subject to many closing
conditions and termination rights. Synta's assets currently consist primarily of cash, cash equivalents and marketable securities, and its listing on The NASDAQ Capital Market. If Synta does not
complete the merger, its board of directors may elect to attempt to complete another strategic transaction similar to the merger. Such attempts will likely be costly and time consuming, and Synta
cannot make any assurances that a future strategic transaction will occur on commercially reasonable terms or at all.
If the merger is not completed, Synta may elect to liquidate its remaining assets, and there can be
no assurances as to the amount of cash available to distribute to stockholders after paying its debts and other obligations.
If Synta does not complete the merger, the board of directors may elect to take the steps necessary to liquidate all of its remaining
assets. The process of liquidation may be lengthy and Synta cannot make any assurances regarding the timing of completing such a process. In addition, Synta would be required to pay all of its debts
and contractual obligations, and to set aside certain reserves for potential future claims. There can be no assurance as to the amount of cash that will be available to distribute to stockholders
after paying Synta's debts and other obligations and setting aside funds for reserves, nor as to the timing of any such distribution.
Synta has a substantial accumulated deficit and expects to continue to incur losses for future
periods.
As of March 31, 2016, Synta had an accumulated deficit of $712.8 million. Synta had a net loss of $6.5 million for
the quarter ended March 31, 2016, and net losses of $68.7 million and $86.2 million for the years ended December 31, 2015 and December 31, 2014, respectively.
Synta's losses for other periods have historically resulted principally from costs incurred in connection with Synta's research and development activities, including clinical trials, and from general
and administrative expenses associated with its operations. Synta expects to continue to incur losses for future periods, including periods following completion of the merger. As a result, following
the completion of the merger, the combined company will need to generate significant revenues to achieve profitability in the future or, if it does achieve profitability for any particular period, to
sustain or grow its profitability on a quarterly or annual basis. Synta derived a substantial portion of its revenue in past years from its strategic alliances and collaborations, which have all
terminated. Synta does not currently have any source of product revenue.
Risks Related to Synta's Common Stock
The market price of Synta's common stock has historically been highly volatile and the merger may
result in significant stock price and trading volume fluctuations.
The trading price of Synta's common stock has historically been highly volatile, and the merger may result in significant stock price
and trading volume fluctuations. Synta cannot predict precisely the impact the announcement, pendency or completion of the merger will have on its stock price. Additionally, the stock market in
general has experienced extreme price and volume fluctuations. The market prices of securities of pharmaceutical, biopharmaceutical and biotechnology companies in particular have been extremely
volatile and have experienced fluctuations that have often been unrelated or disproportionate to operating performance.
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If Synta fails to continue to meet all applicable NASDAQ Capital Market requirements and The NASDAQ
Stock Market determines to delist its common stock, the delisting could adversely affect the market liquidity of Synta's common stock, impair the value of your investment, harm Synta's business, and
impair its ability to complete the merger.
Synta's common stock is currently listed on The NASDAQ Capital Market. In order to maintain that listing, Synta must satisfy minimum
financial and other requirements. On December 3, 2015, Synta received notice from the Listing Qualifications Department of The NASDAQ Stock Market that its common stock had not met the $1.00
per share minimum bid price requirement for the last 30 consecutive business days pursuant to NASDAQ Stock Market Listing Rule 5450(a)(1) and that, if Synta were unable to demonstrate
compliance with this requirement during the applicable grace periods, its common stock would be delisted after that time. The notification letter stated that pursuant to NASDAQ Stock Market Listing
Rule 5810(c)(3)(A) Synta would be afforded 180 calendar days, or until May 31, 2016, to regain compliance with the minimum bid price requirement. In order to regain compliance, shares of
Synta's common stock must maintain a minimum closing bid price of at least $1.00 per share for a minimum of ten consecutive business days. However, Synta was eligible for an additional 180 day
grace period because it satisfied all of the requirements, other than
the minimum bid price requirement, for listing on The NASDAQ Capital Market set forth in NASDAQ Stock Market Listing Rule 5505. Accordingly, on June 2, 2016, Synta's listing was
transferred from The NASDAQ Global Market to The NASDAQ Capital Market. If Synta does not regain compliance by November 28, 2016, The NASDAQ Stock Market will provide written notification to it
that its common stock will be delisted. At that time, Synta may appeal The NASDAQ Stock Market's delisting determination to a NASDAQ Stock Market Listing Qualifications Panel. The closing bid price of
Synta's common stock on The NASDAQ Capital Market was $0.38 on June 6, 2016.
While
Synta intends to engage in efforts to regain compliance, including by effecting the proposed reverse stock split, and thus maintain its listing, there can be no assurance that it
will be able to regain compliance during the applicable time periods set forth above. If Synta fails to continue to meet all applicable NASDAQ Capital Market requirements in the future and The NASDAQ
Stock Market determines to delist its common stock, the delisting could substantially decrease trading in Synta's common stock and adversely affect the market liquidity of Synta's common stock;
adversely affect Synta's ability to obtain financing on acceptable terms, if at all, for the continuation of its operations; and harm Synta's business. Additionally, the market price of Synta's common
stock may decline further and stockholders may lose some or all of their investment.
A small number of Synta's stockholders beneficially own a substantial amount of Synta's common stock
and have substantial control over Synta; therefore, your ability to influence corporate matters may be limited.
Certain stockholders affiliated with Synta's officers and directors collectively beneficially own or control approximately 18.8% of
Synta's outstanding common stock as of May 2, 2016 and acting together, may have the ability to affect matters submitted to Synta's stockholders for approval, including the approval of
significant transactions, like the merger. This concentration of ownership may have the effect of delaying, deferring or preventing a strategic transaction, even if such a transaction would benefit
other stockholders.
Fluctuations in Synta's operating results could adversely affect the price of Synta's common stock.
Synta's operating results are likely to fluctuate significantly from quarter to quarter and year to year. These fluctuations could
cause Synta's stock price to decline. Some of the factors that may cause Synta's operating results to fluctuate on a period-to-period basis include:
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whether Synta pursues and completes any merger, acquisition or other significant corporate transaction, and, if it does, the
associated terms in each case;
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restructuring costs;
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implementation or termination of collaborations, licensing, manufacturing or other material agreements with third parties, and any
non-recurring revenue or expenses under any such agreement;
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the extent of Synta's general and administrative expenses;
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general and industry-specific economic conditions; and
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general conditions in the pharmaceutical, biopharmaceutical or biotechnology industries or in the U.S. or global credit or financial
markets.
Due
to fluctuations in Synta's operating results, a period-to-period comparison of Synta's results of operations may not be meaningful, and investors should not rely on them as a good
indication of Synta's future performance. Fluctuations in Synta's operating results may not meet the expectations of securities analysts or investors. Failure to meet these expectations may cause the
price of Synta's common stock to decline.
These
and other external factors may cause the market price and demand for Synta's common stock to fluctuate substantially, which may limit or prevent investors from readily selling its
shares of common stock and may otherwise negatively affect the liquidity of Synta's common stock. In addition, in the past, when the market price of a stock has been volatile, holders of that stock
have instituted securities class action litigation against the company that issued the stock. If any of Synta's stockholders brought a lawsuit against Synta, it could incur substantial costs defending
the lawsuit. Such a lawsuit could also divert the time and attention of Synta's management.
If Synta's stockholders sell a substantial number of shares of Synta's common stock in the public
market, Synta's stock price may decline.
Synta's current trading volumes are modest, and sales of a substantial number of shares of its common stock in the public market, or
the perception that these sales could occur, could cause the market price to decline. Such sales also might make it more difficult for Synta to sell equity securities in the future at a time and at a
price that it deems appropriate. If there are more shares of Synta's common stock offered for sale than buyers are willing to purchase, the market price of Synta's common stock may decline to a market
price at which buyers are willing to purchase the offered shares and sellers remain willing to sell the shares. The number of shares of Synta's common stock owned by its stockholders and available for
sale in the public market is limited only to the extent provided under applicable federal securities laws. In addition, Synta may, in the future, issue additional shares of its common stock as
compensation to its employees, directors or consultants, in connection with strategic alliances, collaborations, acquisitions or other transactions or to raise capital. Accordingly, sales of a
substantial number of shares of Synta's common stock in the public market could occur at any time.
Provisions of Synta's charter, bylaws, and Delaware law may make an acquisition of Synta or a change
in its management more difficult.
Certain provisions of Synta's restated certificate of incorporation and restated bylaws could discourage, delay, or prevent a merger,
acquisition, or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions also
could limit the price that investors might be willing to pay in the future for shares of Synta's common stock, thereby depressing the market price of its common stock. Stockholders who wish to
participate in these transactions may not have the opportunity to do so. Furthermore, these provisions could prevent or frustrate attempts by Synta's stockholders to replace or remove Synta's
management.
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These
provisions:
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allow the authorized number of directors to be changed only by resolution of Synta's board of directors;
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establish a classified board of directors, providing that not all members of the board of directors be elected at one time;
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authorize Synta's board of directors to issue without stockholder approval blank check preferred stock that, if issued, could operate
as a "poison pill" to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that is not approved by Synta's board of directors;
-
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require that stockholder actions must be effected at a duly called stockholder meeting and prohibit stockholder action by written
consent;
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establish advance notice requirements for stockholder nominations to Synta's board of directors or for stockholder proposals that can
be acted on at stockholder meetings;
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limit who may call stockholder meetings; and
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require the approval of the holders of 80% of the outstanding shares of Synta's capital stock entitled to vote in order to amend
certain provisions of Synta's restated certificate of incorporation and restated bylaws.
In
addition, because Synta is incorporated in Delaware, it is governed by the provisions of Section 203 of the Delaware General Corporation Law, or DGCL, which may, unless certain
criteria are met, prohibit large stockholders, in particular those owning 15% or more of Synta's outstanding voting stock, from merging or combining with Synta for a prescribed period of time.
Synta does not anticipate paying cash dividends, and accordingly, Synta's stockholders must rely on
stock appreciation for any return on their investment.
Synta currently intends to retain its future earnings, if any, to fund the development and growth of its business. In addition, Synta
is currently prohibited from making a dividend payment under the terms of the Merger Agreement. As a result, capital appreciation, if any, of Synta's common stock will be the sole source of gain on an
investment in Synta's common stock for the foreseeable future.
Risks Related to Madrigal's Business
Madrigal has a limited operating history, has incurred significant operating losses since inception
and expects to incur significant operating losses for the foreseeable future. Madrigal may never become profitable or, if achieved, be able to sustain profitability.
To date, Madrigal has funded its operations primarily through private placement offerings of debt and equity securities. From
September 16, 2011 through March 31, 2016, Madrigal received net proceeds of approximately $15.5 million from the issuance of convertible notes. In addition, on April 13,
2016, concurrent with the execution of the Merger Agreement, certain securityholders of Madrigal agreed to invest $9.0 million of gross proceeds in Madrigal prior to the consummation of the
merger, which is referred to herein as the Private Placement. As of March 31, 2016, Madrigal had cash and cash equivalents of $0.6 million. Madrigal has incurred significant operating
losses since its inception and expects to incur significant losses for the foreseeable future as Madrigal continues its clinical trial and development programs for MGL-3196 and other future product
candidates. In the future, Madrigal intends to continue to conduct research and development, clinical testing, regulatory compliance and, if MGL-3196 or other future product candidates are approved,
sales and marketing activities that, together with anticipated general and administrative expenses, will likely result in Madrigal incurring further significant losses for the foreseeable future.
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Madrigal
currently generates no revenue from product sales, and may never be able to commercialize MGL-3196 or other future product candidates. Madrigal does not currently have the
required approvals to market MGL-3196 or any other future product candidates, and Madrigal may never receive them. Madrigal may not be profitable even if it or any of its future development partners
succeed in commercializing any of Madrigal's product candidates. Because of the numerous risks and uncertainties associated with developing and commercializing Madrigal's product candidates, Madrigal
is unable to predict the extent of any future losses or when it will become profitable, if at all.
Madrigal's business depends on the success of MGL-3196, which is still in clinical development. If
Madrigal is unable to obtain regulatory approval for or successfully commercialize MGL-3196, its business will be materially harmed.
To date, the sole focus of Madrigal's product development has been MGL-3196, a liver-directed selective thyroid hormone receptor beta
agonist for potential use in NASH and FH. Successful continued development and ultimate regulatory approval of MGL-3196 for NASH or genetic dyslipidemias, such as FH, is critical to the future success
of its business. Madrigal has invested, and will continue to invest, a significant portion of its time and financial resources in the
clinical development of MGL-3196. Madrigal will need to raise sufficient funds to successfully complete its clinical development program for MGL-3196 in NASH and FH. The future regulatory and
commercial success of MGL-3196 is subject to a number of risks, including the following:
-
-
Madrigal may not have sufficient financial and other resources to complete the necessary clinical trials for MGL-3196, including but
not limited to Phase 2 clinical trials and, later, registrational clinical trials to obtain drug approval;
-
-
the mechanism of action of MGL-3196 is complex and Madrigal does not know the degree to which it will translate into a therapeutic
benefit, if any, in NASH, FH or any other indication, and Madrigal does not know the degree to which the complex mechanism of action may contribute to long term safety issues or adverse events, if
any, when MGL-3196 is taken for prolonged periods such as in the treatment of NASH, FH or any other indication;
-
-
Madrigal may not be able to obtain adequate evidence from clinical trials of efficacy and safety for MGL-3196 in NASH, FH or any other
indication;
-
-
Madrigal does not know the degree to which MGL-3196 will be accepted as a therapy by physicians, patients and payors, even if
approved;
-
-
in its clinical programs for MGL-3196, Madrigal may experience variability in patients, adjustments to clinical trial procedures and
the need for additional clinical trial sites, which could delay its clinical trial progress;
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-
the results of its clinical trials may not meet the level of statistical or clinical significance required by the United States Food
and Drug Administration, or FDA, or comparable foreign regulatory bodies for marketing approval;
-
-
patients in Madrigal's clinical trials may die or suffer other adverse effects for reasons that may or may not be related to MGL-3196,
which could delay or prevent further clinical development;
-
-
the standards implemented by clinical or regulatory agencies may change at any time;
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-
the FDA or foreign clinical or regulatory agencies may require efficacy endpoints for a Phase 3 clinical trial for the
treatment of NASH or FH that differ from the endpoints of Madrigal's current or future trials, which may require Madrigal to conduct additional clinical trials;
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if approved for NASH, MGL-3196 will likely compete with the off-label use of currently marketed products and other therapies in
development that may reach approval for NASH prior to MGL-3196;
-
-
if approved for FH, MGL-3196 will likely compete with currently approved and marketed products and other therapies in development that
may reach approval for FH prior to MGL-3196; and
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-
Madrigal may not be able to obtain, maintain or enforce its patents and other intellectual property rights.
Of
the large number of drugs in development in the pharmaceutical industry, only a small percentage results in the submission of a new drug application, or NDA, to the FDA and even fewer
are approved for commercialization. Furthermore, even if Madrigal does receive regulatory approval to market MGL-3196, any such approval may be subject to limitations on the indicated uses or patient
populations for which Madrigal may market the products. Accordingly, even if Madrigal is able to obtain the requisite financing to continue to fund its development programs, Madrigal may be unable to
successfully develop or commercialize MGL-3196. If Madrigal or any of its future development partners are unable to develop, or obtain regulatory approval for, or, if approved, successfully
commercialize MGL-3196, Madrigal may not be able to generate sufficient revenue to continue its business.
The results of preclinical studies and early clinical trials are not always predictive of future
results. Any product candidate that Madrigal advances into clinical trials, including MGL-3196, may not have favorable results in later clinical trials or receive regulatory approval.
Drug development has inherent risk. Madrigal will be required to demonstrate through adequate and well-controlled clinical trials that
its product candidates are safe and effective, with a favorable benefit-risk profile, for use in their target indications before Madrigal can seek regulatory approvals for their commercial sale.
Clinical studies are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. Delay or failure can occur at any stage of development, including
after commencement of any of Madrigal's clinical trials. In addition, success in early clinical trials does not mean that later clinical trials will be successful, because later-stage clinical trials
may be conducted in broader patient populations and involve different study designs. For instance, Madrigal's Phase 1 results may not be predictive of any future Phase 2 results.
Furthermore, Madrigal's future trials will need to demonstrate sufficient safety and efficacy in larger patient populations for approval by regulatory authorities. Companies frequently suffer
significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results. In addition, only a small percentage of drugs under development result in the
submission of an NDA to the FDA and even fewer are approved for commercialization.
Madrigal
cannot be certain that any of its ongoing or future clinical trials will be successful, and any safety concerns observed in any one of its clinical trials in its targeted
indications could limit the prospects for regulatory approval of its product candidates in those and other indications.
If Madrigal encounters difficulties enrolling patients in its clinical trials, its clinical
development activities could be delayed or otherwise adversely affected.
Madrigal may not be able to initiate, continue, or complete clinical trials required by the FDA or foreign regulatory agencies for
MGL-3196 if it is unable to locate and enroll a sufficient number of eligible patients to participate in these clinical trials. Patient enrollment, a significant factor in the timing to conduct and
complete clinical trials, is affected by many factors, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the
design of the clinical trial, competing clinical trials, and clinicians' and patients' perceptions as to
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the
potential advantages and disadvantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications Madrigal is
investigating. In the proposed clinical trials, patient willingness to undergo a liver biopsy in Madrigal's NASH trials, and identification of patients willing to participate in Madrigal's FH trials
due to the rarity of the disease, are also risk factors. Potential patients for MGL-3196 may not be adequately diagnosed or identified with the diseases which Madrigal is targeting or may not meet the
entry criteria for Madrigal's studies.
The
FDA typically requires sponsors of lipid-lowering product candidates to conduct drug-drug interaction studies with statins because statins may have increased safety risks when
administered together with other drug therapies that affect their pharmacokinetic profile. Accordingly, shortly after Madrigal submitted an IND for MGL-3196, the FDA placed a partial clinical hold on
MGL-3196 with respect to clinical dosing of MGL-3196 with statins. Madrigal conducted its planned clinical dose escalation trials and, later, upon submitting a request to the FDA, the FDA advised
Madrigal that conducting clinical drug interaction studies between MGL-3196 and statins might be sufficient to address the partial clinical hold. Madrigal has completed one clinical drug interaction
study between MGL-3196 and two statins, and is currently conducting a second similar drug interaction study between MGL-3196 and a third statin, the results of which will be submitted, along with
other information, to the FDA in support of Madrigal's request to the FDA that it remove the partial clinical hold. The timing of the FDA's response may affect the timing or enrollment of clinical
trials in which MGL-3196 is dosed concomitantly with statins, including the FH Phase 2 clinical trial and, to a lesser extent, the NASH Phase 2 clinical trial.
Madrigal
will be required to identify and enroll a sufficient number of patients for each of its ongoing and planned clinical trials of MGL-3196 for NASH and FH indications,
respectively. Madrigal also may encounter difficulties in identifying and enrolling NASH patients and FH patients with a stage of disease appropriate for its ongoing or future clinical trials.
Madrigal may not be able to initiate or
continue clinical trials if it is unable to locate a sufficient number of eligible patients to participate in the clinical trials required by the FDA or other foreign regulatory agencies. In addition,
the process of finding and diagnosing patients may prove costly. Madrigal's inability to enroll a sufficient number of patients for any of its clinical trials would result in significant delays or may
require Madrigal to abandon one or more clinical trials.
If clinical trials or regulatory approval processes for Madrigal's product candidates are prolonged,
delayed or suspended, Madrigal may be unable to commercialize its product candidates on a timely basis, which would require Madrigal to incur additional costs and delay Madrigal's receipt of any
revenue from potential product sales.
Madrigal cannot predict whether it will encounter problems with any of its completed, ongoing or planned clinical trials that will
cause Madrigal or any regulatory authority to delay or suspend those clinical trials or delay the analysis of data derived from them. A number of events, including any of the following, could delay
the completion of Madrigal's ongoing and planned clinical trials and negatively affect its ability to obtain regulatory approval for, and to market and sell, a particular product
candidate:
-
-
conditions imposed on Madrigal by the FDA or other regulatory authorities regarding the scope or design of its clinical trials;
-
-
insufficient supply of Madrigal product candidates or other materials necessary to conduct and complete its clinical trials;
-
-
slow enrollment and retention rate of subjects in its clinical trials; and
-
-
serious and unexpected drug-related side effects related to the product candidate being tested.
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Commercialization
of Madrigal's product candidates may be delayed by the imposition of additional conditions on its clinical trials by the FDA or any other applicable foreign regulatory
authority or the requirement of additional supportive studies by the FDA or such foreign regulatory authority.
Madrigal
does not know whether Madrigal's clinical trials will begin as planned, will need to be restructured, or will be completed on schedule, if at all. Delays in the initiation,
enrollment or completion of Madrigal's clinical trials will result in increased development costs for its product candidates, and its financial resources may be insufficient to fund any incremental
costs. In addition, if Madrigal's clinical trials are delayed, its competitors may be able to bring products to market before it does and the commercial viability of its product candidates could be
limited.
If Madrigal fails to obtain the capital necessary to fund its operations, Madrigal will be unable to
successfully develop and commercialize MGL-3196 and other future product candidates.
Although Madrigal believes that the net cash of Synta available at the closing of the merger, together with Madrigal's existing cash
and cash equivalents and the proceeds from the Private Placement, will be sufficient to fund Madrigal's current operations through at least the third quarter of 2017, Madrigal will require substantial
additional future working capital in order to complete the remaining clinical development for MGL-3196 and Madrigal's other product candidates through potential regulatory approval and through
potential commercialization of these product candidates. In particular, in order to initiate its Phase 3 clinical program for MGL-3196 in NASH, Madrigal will need to collaborate with a
strategic partner or raise significant financing. Madrigal expects its spending levels to increase in connection with its clinical trials of MGL-3196 as well as other corporate activities. The amount
and timing of any expenditure needed to implement Madrigal's development and commercialization programs will depend on numerous factors, including:
-
-
the type, number, scope, progress, expansion costs, results of and timing of Madrigal's ongoing or future clinical trials or the need
for additional clinical trials of MGL-3196 for NASH and FH or any other product candidates which Madrigal is pursuing or may choose to pursue in the future;
-
-
the costs of obtaining, maintaining and enforcing its patents and other intellectual property rights;
-
-
the costs and timing of obtaining or maintaining manufacturing for MGL-3196 for NASH and FH and any other product candidates,
including commercial manufacturing if any product candidate is approved;
-
-
the costs and timing of establishing sales, marketing and reimbursement capabilities and enhanced internal controls over financial
reporting;
-
-
the terms and timing of establishing and maintaining collaborations, license agreements and other partnerships;
-
-
costs associated with any new product candidates that Madrigal may develop, in-license or acquire;
-
-
the effect of competing technological and market developments;
-
-
the costs associated with being a public company; and
-
-
the costs of obtaining regulatory approval.
Some
of these factors are outside of Madrigal's control. Madrigal does not expect its existing capital resources, together with the net cash of Synta at the closing of the merger and the
proceeds from the Private Placement, to be sufficient to enable it to fund the completion of its clinical trials and
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commercialization
of its product candidates. Madrigal expects that it will need to raise substantial additional funds in the future.
Madrigal
has not sold any products, and it does not expect to sell or derive revenue from any product sales for the foreseeable future. Madrigal may seek additional funding through
future debt financings and potentially dilutive equity financings, as well as potential additional collaborations or strategic partnerships with other companies or through non-dilutive financings.
Additional funding may not be available to Madrigal on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of Madrigal's stockholders.
In addition, the issuance of additional shares by Madrigal, or the possibility of such issuance, may cause the market price of Madrigal's shares to decline.
If
Madrigal is unable to obtain additional funding on a timely basis, Madrigal may be unable to complete planned clinical trials for MGL-3196 for NASH and FH and any of its other product
candidates, and Madrigal may be required to significantly curtail some or all of its activities. Madrigal also could be required to seek funds through arrangements with collaborative partners or
otherwise that may require Madrigal to relinquish rights to its product candidates or otherwise agree to terms unfavorable to Madrigal.
Madrigal's product candidates will remain subject to ongoing regulatory review even if they receive
marketing approval, and if Madrigal fails to comply with continuing regulations, Madrigal could lose these approvals and the sale of any approved Madrigal commercial products could be suspended.
Even if Madrigal receives regulatory approval to market a particular product candidate, the manufacturing, labeling, packaging, adverse
event reporting, storage, advertising, promotion, and record keeping related to the product will remain subject to extensive regulatory requirements. If Madrigal fails to comply with the regulatory
requirements of the FDA and other applicable domestic and foreign regulatory authorities, or previously unknown problems with any
approved product, manufacturer, or manufacturing process are discovered, Madrigal could be subject to administrative or judicially imposed sanctions,
including:
-
-
restrictions on the products, manufacturers, or manufacturing processes;
-
-
warning letters;
-
-
civil or criminal penalties;
-
-
fines;
-
-
injunctions;
-
-
product seizures or detentions;
-
-
pressure to initiate voluntary product recalls;
-
-
suspension or withdrawal of regulatory approvals; and
-
-
refusal to approve pending applications for marketing approval of new products or supplements to approved applications.
Madrigal's industry is highly competitive, and its product candidates may become obsolete.
Madrigal is engaged in a rapidly evolving field. Competition from other pharmaceutical companies, biotechnology companies and research
and academic institutions is intense and likely to increase. Many of those companies and institutions have substantially greater financial, technical and human resources than Madrigal. Those companies
and institutions also have substantially greater experience in developing products, conducting clinical trials, obtaining regulatory approval and in manufacturing and
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marketing
pharmaceutical products. Madrigal's competitors may succeed in obtaining regulatory approval for their products more rapidly than it does. Competitors have developed or are in the process of
developing technologies that are, or in the future may be, the basis for competitive products. Some of these competitive products may have an entirely different approach or means of accomplishing the
desired therapeutic effect than products being developed by Madrigal. Madrigal's competitors may succeed in developing products that are more effective and/or cost competitive than those it is
developing, or that would render its product candidates less competitive or even obsolete. In addition, one or more of Madrigal's competitors may achieve product commercialization or patent protection
earlier than Madrigal, which could materially adversely affect Madrigal's business.
If the FDA or other applicable regulatory authorities approve generic products that compete with any
of Madrigal's or any of its partners' product candidates, the sales of Madrigal's product candidates would be adversely affected.
Once an NDA or marketing authorization application outside the United States is approved, the product covered thereby becomes a "listed
drug" that can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application in the United
States. Agency regulations and other applicable regulations and policies provide incentives to manufacturers to create modified, non-infringing versions of a drug to facilitate the approval of an
abbreviated new drug application or other application for generic substitutes in the United States and in nearly every pharmaceutical market around the world. These manufacturers might only be
required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use, or labeling, as
Madrigal's product and that the generic product is bioequivalent to Madrigal's product, meaning it is absorbed in the body at the same rate and to the same extent as Madrigal's product. These generic
equivalents, which must meet the same quality standards as branded pharmaceuticals, would be significantly less costly than Madrigal's product to bring to market, and companies that produce generic
equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product are typically
lost to the generic product. Accordingly, competition from generic equivalents to Madrigal's product or any of its partners' future products, if any, would materially adversely affect Madrigal's
future revenue, profitability and cash flows and substantially limit its ability to obtain a return on the investments Madrigal has made and expects to make in its or any of its partners' product
candidates, including MGL-3196.
If physicians and patients do not accept Madrigal's future products or if the market for indications
for which any product candidate is approved is smaller than expected, Madrigal may be unable to generate significant revenue, if any.
Even if any of Madrigal's product candidates obtain regulatory approval, they may not gain market acceptance among physicians,
patients, and third-party payers. Physicians may decide not to recommend its treatments for a variety of reasons including:
-
-
timing of market introduction of competitive products;
-
-
demonstration of clinical safety and efficacy compared to other products;
-
-
cost-effectiveness;
-
-
limited or no coverage by third-party payers;
-
-
convenience and ease of administration;
-
-
prevalence and severity of adverse side effects;
-
-
restrictions in the label of the drug;
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other potential advantages of alternative treatment methods; and
-
-
ineffective marketing and distribution support of its products.
If
any of Madrigal's product candidates are approved, but fail to achieve market acceptance or such market is smaller than anticipated, Madrigal may not be able to generate significant
revenue and its business would suffer.
As Madrigal evolves from a company that is primarily involved in clinical development to a company
that is also involved in commercialization, it may encounter difficulties in expanding its operations successfully.
As Madrigal advances its product candidates through clinical trials, it will need to expand its development, regulatory, manufacturing,
and marketing and sales capabilities and may need to further contract with third parties to provide these capabilities. As its operations expand, Madrigal likely will need to manage additional
relationships with such third parties, as well as additional collaborators, distributors, marketers and suppliers.
Maintaining
third party relationships for these purposes will impose significant added responsibilities on members of its management and other personnel. Madrigal must be able to
effectively manage its development efforts; recruit and train sales and marketing personnel, effectively manage its participation in the clinical trials in which its product candidates are involved
and improve its managerial, development, operational and finance systems, all of which may impose a strain on Madrigal's administrative and operational infrastructure.
If
Madrigal enters into arrangements with third parties to perform sales, marketing or distribution services, any product revenues that it receives, or the profitability of these product
revenues to Madrigal, are likely to be lower than if Madrigal were to market and sell any products that it develops without the involvement of these third parties. In addition, Madrigal may not be
successful in entering into arrangements with third parties to sell and market its products or in doing so on terms that are favorable to Madrigal. Madrigal likely will have little control over such
third parties, and any of them may fail to devote the necessary resources and attention to sell and market its products effectively. If Madrigal does not establish sales and marketing capabilities
successfully, either on its own or in collaboration with third parties, Madrigal will not be successful in commercializing its products.
The uncertainty associated with pharmaceutical reimbursement and related matters may adversely
affect Madrigal's business.
Market acceptance and sales of any one or more of Madrigal's product candidates will depend on reimbursement policies and may be
affected by future healthcare reform measures in the United States and in foreign jurisdictions. Government authorities and third-party payers, such as private health insurers and health maintenance
organizations, decide which drugs they will cover and establish payment levels. Madrigal cannot be certain that reimbursement will be available for any of Madrigal's product candidates. Also, Madrigal
cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, Madrigal products. If reimbursement is not available or is available on a limited basis, Madrigal
may not be able to successfully commercialize any product candidates that it develops.
In
the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the Medicare Modernization Act, or MMA, changed the way Medicare covers and
pays for pharmaceutical products. The legislation established Medicare Part D, which expanded Medicare coverage for outpatient prescription drug purchases by the elderly but provided authority
for limiting the number of drugs that will be covered in any therapeutic class. The MMA also introduced a new reimbursement methodology based on average sales prices for physician-administered drugs.
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The
United States and several foreign jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways
that could affect its ability to sell its products profitably. Among policy makers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare
systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of
these efforts and has been significantly affected by major legislative initiatives. Madrigal expects to experience pricing pressures in connection with the sale of any products that it develops due to
the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative proposals.
In
March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, ACA, became law in the
United States. The goal of ACA is to reduce the cost of healthcare and substantially change the way healthcare is financed by both government and private insurers. While Madrigal cannot predict what
impact on federal reimbursement policies this legislation will have in general or on Madrigal's business specifically, the ACA may result in downward pressure on pharmaceutical reimbursement, which
could negatively affect market acceptance of, and the price Madrigal may charge for, any products it develops that receive regulatory approval. Madrigal also cannot predict the impact of ACA on
Madrigal as many of the ACA reforms require the promulgation of detailed regulations implementing the statutory provisions, which have not yet been fully implemented.
If any product liability lawsuits are successfully brought against Madrigal or any of its
collaborative partners, Madrigal may incur substantial liabilities and may be required to limit commercialization of its product candidates.
Madrigal faces an inherent risk of product liability lawsuits related to the testing of its product candidates in seriously ill
patients and will face an even greater risk if product candidates are approved by regulatory authorities and introduced commercially. Product liability claims may be brought against Madrigal or its
partners by participants enrolled in Madrigal's clinical trials,
patients, healthcare providers or others using, administering or selling any of Madrigal's future approved products. If Madrigal cannot successfully defend itself against any such claims, it may incur
substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
-
-
decreased demand for any of Madrigal's future approved products;
-
-
injury to Madrigal's reputation;
-
-
withdrawal of clinical trial participants;
-
-
termination of clinical trial sites or entire trial programs;
-
-
significant litigation costs;
-
-
substantial monetary awards to or costly settlements with patients or other claimants;
-
-
product recalls or a change in the indications for which products may be used;
-
-
loss of revenue;
-
-
diversion of management and scientific resources from Madrigal's business operations; and
-
-
the inability to commercialize Madrigal's product candidates.
If
any of Madrigal's product candidates are approved for commercial sale, Madrigal will be highly dependent upon consumer perceptions of Madrigal and the safety and quality of its
products. Madrigal could be adversely affected if it is subject to negative publicity. Madrigal could also be adversely affected if any of its products or any similar products distributed by other
companies prove to be, or
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are
asserted to be, harmful to patients. Also, because of Madrigal's dependence upon consumer perceptions, any adverse publicity associated with illness or other adverse effects resulting from
patients' use or misuse of Madrigal's products or any similar products distributed by other companies could have a material adverse impact on Madrigal's results of operations.
Madrigal
does not currently hold product liability insurance coverage. Prior to commercialization of its product candidates, Madrigal will need to purchase insurance coverage. As a
result, Madrigal may be unable to maintain or obtain sufficient insurance at a reasonable cost to protect Madrigal against losses that could have a material adverse effect on its business. These
liabilities could prevent or interfere with Madrigal's product development and commercialization efforts. A successful product liability claim or series of claims brought against Madrigal,
particularly if judgments exceed Madrigal's insurance coverage, could decrease Madrigal's cash resources and adversely affect its business, financial condition and results of operations.
Madrigal's employees, contractors and partners may engage in misconduct or other improper
activities, including noncompliance with regulatory standards and requirements and insider trading.
Madrigal is exposed to the risk of fraud or other misconduct by its employees, contractors or partners. Misconduct by these parties
could include failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial
information or data timely, completely or accurately, or to disclose unauthorized activities to Madrigal. In particular, sales, marketing and business arrangements in the healthcare industry are
subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range
of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Third-party misconduct could also involve the improper use of
information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to Madrigal's reputation. It is not always possible to identify and deter misconduct,
and the precautions Madrigal takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Madrigal from governmental
investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against Madrigal resulting from this misconduct and
Madrigal is not successful in defending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition of significant fines or other sanctions.
Madrigal enters into various contracts in the normal course of its business in which Madrigal
indemnifies the other party to the contract. In the event Madrigal has to perform under these indemnification provisions, it could have a material adverse effect on its business, financial condition
and results of operations.
In the normal course of business, Madrigal periodically enters into academic, commercial, service, collaboration, licensing, consulting
and other agreements that contain indemnification provisions. With respect to Madrigal's academic and other research agreements, Madrigal typically indemnifies the institution and related parties from
losses arising from claims relating to the products, processes or services made, used, sold or performed pursuant to the agreements for which Madrigal has secured licenses, and from claims arising
from Madrigal's or its potential sublicensees' exercise of rights under the agreement. With respect to Madrigal's commercial agreements, Madrigal indemnifies its vendors from any third-party product
liability claims that could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual property right by a third party.
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Should Madrigal's obligation under an indemnification provision exceed applicable insurance coverage or if Madrigal were denied insurance coverage, Madrigal's
business, financial condition and results of operations could be adversely affected. Similarly, if Madrigal is relying on a collaborator to indemnify Madrigal and the collaborator is denied insurance
coverage or the indemnification obligation exceeds the applicable insurance coverage, and if the collaborator does not have other assets available to indemnify Madrigal, its business, financial
condition and results of operations could be adversely affected.
Because MGL-3196 has not yet received regulatory approval for any indication, it is difficult to
predict the time and cost of development and Madrigal's ability to successfully complete clinical development and obtain the necessary regulatory approvals for commercialization.
MGL-3196 has not yet received regulatory approval for the treatment of NASH, FH or any other indication, and unexpected problems may
arise that could cause Madrigal to delay, suspend or terminate its development efforts in any or all indications. Further, MGL-3196 has
not yet demonstrated efficacy in patients with NASH or FH, and the long-term safety consequences of a liver-directed thyroid hormone receptor beta agonist are not known. Regulatory approval of new
product candidates such as MGL-3196 can be more expensive and take longer than approval for candidates for the treatment of more well-understood diseases with previously approved products.
Any product candidate in Madrigal's current or future clinical trials may cause unacceptable adverse
events or have other properties that may delay or prevent its regulatory approval or commercialization or limit its commercial potential.
Unacceptable adverse events caused by any of Madrigal's product candidates in current or future clinical trials could cause Madrigal or
regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications
and markets. This in turn could prevent Madrigal from completing development of or commercializing the affected product candidate and generating revenue from its sale. If any of Madrigal's product
candidates cause unacceptable adverse events in clinical trials, Madrigal may not be able to obtain regulatory approval or commercialize such product candidate.
If Madrigal fails to develop and commercialize other product candidates, Madrigal may be unable to
grow its business.
Although the development and commercialization of MGL-3196 is Madrigal's primary focus, as part of its longer-term growth strategy,
Madrigal plans to evaluate the development and commercialization of other therapies related to thyroid hormone, orphan and other diseases. Madrigal will evaluate internal opportunities from its
compound libraries, and also may choose to in-license or acquire other product candidates as well as commercial products to treat patients suffering from thyroid hormone, orphan or other disorders
with high unmet medical needs and limited treatment options. These other product candidates may require additional, time-consuming development efforts prior to commercial sale, including preclinical
studies, clinical trials and approval by the FDA and/or applicable foreign regulatory authorities. All product candidates are prone to the risks of failure that are inherent in pharmaceutical product
development, including the possibility that the product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, Madrigal cannot assure
you that any such products that are approved will be manufactured or produced economically, be successfully commercialized, be widely accepted in the marketplace, or be more effective than other
commercially available alternatives.
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Risks Related to Madrigal's Intellectual Property
Madrigal's rights to develop and commercialize its product candidates are subject in part to the
terms and conditions of a license to MGL-3196 granted to Madrigal by Roche.
Madrigal entered into a research, development and commercialization agreement, or the Roche Agreement, with Hoffmann-La Roche
Pharmaceutical Company Limited, or Roche, on December 18, 2008. Pursuant to the terms of the Roche Agreement, Madrigal assumed control of all development and commercialization of MGL-3196 and
will own exclusive worldwide rights for all potential indications. Roche assigned all patent rights relating to MGL-3196 to Madrigal and granted Madrigal an exclusive license to use certain know-how
relating to MGL-3196 in exchange for consideration consisting of an upfront payment, milestone payments tied to the achievement of product development and regulatory milestones, and royalty payments
based on net sales of products containing MGL-3196, subject to certain reductions. Madrigal must use commercially reasonable efforts to conduct clinical and commercial development programs for
products containing MGL-3196. If Madrigal determines that it is not reasonable to continue clinical trials or other development of MGL-3196, it may elect to cease further development and Roche may
terminate the license. If Madrigal determines not to pursue the development or commercialization of MGL-3196 in certain jurisdictions, including the United States, Roche may terminate the license for
such territories. The Roche Agreement will expire, unless earlier terminated pursuant to other provisions of the agreement, on the last to occur of (i) the expiration of the last valid claim of
a licensed patent covering the manufacture, use or sale of products containing MGL-3196, or (ii) ten years after the first sale of a product containing MGL-3196.
Madrigal
does not have, nor has Madrigal had, any material disputes with Roche regarding the Roche Agreement. However, if there is any future dispute between Madrigal and Roche regarding
the parties' rights under the Roche Agreement, Madrigal's ability to develop and commercialize MGL-3196 may be materially harmed. Any uncured, material breach under the Roche Agreement could result in
Madrigal's loss of exclusive rights to MGL-3196 and may lead to a complete termination of the Roche Agreement and force Madrigal to cease product development efforts for MGL-3196.
Madrigal may fail to comply with any of its obligations under agreements pursuant to which it
licenses rights or technology, which could result in the loss of rights or technology that are material to Madrigal's business.
Madrigal may enter into license agreements from time to time. Licensing of intellectual property is important to Madrigal's business
and involves complex legal, business and scientific issues. Disputes may arise regarding intellectual property subject to a licensing agreement, including but not limited
to:
-
-
the scope of rights granted under the license agreement and other interpretation-related issues;
-
-
the extent to which Madrigal's technology and processes infringe on intellectual property of the licensor that is not subject to the
licensing agreement;
-
-
the sublicensing of patent and other rights;
-
-
Madrigal's diligence obligations under the license agreement and what activities satisfy those diligence obligations;
-
-
the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Madrigal and its
licensors and collaborators; and
-
-
the priority of invention of patented technology.
If
disputes over intellectual property and other rights that Madrigal has licensed or acquired from third parties prevent or impair Madrigal's ability to maintain its current licensing
arrangements on acceptable terms, Madrigal may be unable to successfully develop and commercialize the affected product candidates.
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Madrigal's success depends on its ability to protect its intellectual property and its proprietary
technologies.
Madrigal's success depends on its ability to protect its intellectual property and its proprietary technologies. Madrigal's commercial
success depends in part on its ability to obtain and maintain patent protection and trade secret protection for its product candidates, proprietary technologies, and their uses, as well as its ability
to operate without infringing upon the proprietary rights of others.
Madrigal
can provide no assurance that its patent applications or those of its licensors will result in additional patents being issued or that issued patents will afford sufficient
protection against competitors with similar technologies, nor can Madrigal provide any assurance that the patents issued will not be infringed, designed around or invalidated by third parties. Even
issued patents may later be found unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for
Madrigal's proprietary rights is uncertain. Only limited protection may be available and may not adequately protect Madrigal's rights or permit Madrigal to gain or keep any competitive advantage. This
failure to properly protect the intellectual property rights relating to Madrigal's product candidates could have a material adverse effect on its financial condition and results of operations.
Composition-of-matter patents on the biological or chemical active pharmaceutical ingredients are generally considered to offer the strongest protection of intellectual property and provide the
broadest scope of patent protection for pharmaceutical products, as such patents provide protection without regard to any method of use or any method of manufacturing. While Madrigal owns and has
licensed rights to issued composition-of-matter patents in the United States and other jurisdictions for MGL-3196, Madrigal cannot be certain that the claims in issued composition-of-matter patents
will not be found invalid or unenforceable if challenged. Madrigal cannot be certain that the claims in owned and licensed patent applications covering its product candidates will be considered
patentable by the United States Patent and Trademark Office, or USPTO, and valid by courts in the United States or by the patent offices and courts in foreign jurisdictions. Even if Madrigal's owned
and licensed patent applications covering its product candidates do issue as patents, the patents may not be enforced against competitors. For
example, a formulation patent will not be enforced against those making and marketing a product that has the same active pharmaceutical ingredient in a different formulation that is not claimed in the
formulation patent. Method-of-use patents protect the use of a product for the specified method or for treatment of a particular indication. This type of patent may not be enforced against competitors
making and marketing a product that has the same active pharmaceutical ingredient but is used for a method not claimed in the patent. Moreover, even if competitors do not actively promote their
product for Madrigal's targeted indications, physicians may prescribe these products "off-label." Although off-label prescriptions may infringe or contribute to the infringement of method-of-use
patents, the practice is common and such infringement is difficult to prevent or prosecute.
Madrigal's
licensed composition-of-matter patent from Roche for MGL-3196 is expected to expire in the United States in 2026. Madrigal's owned patents and pending patent applications that
cover solid form, method of manufacturing, and use of MGL-3196 to treat various indications are expected to expire in 2033. While patent term adjustments or patent term extensions could result in
later expiration dates for each of these patents, there can be no assurances that Madrigal will receive any patent adjustments or patent term extensions. The patent application process and patent
maintenance and enforcement are subject to numerous risks and uncertainties, and there can be no assurance that Madrigal or any of its future development partners will be successful in protecting
Madrigal's product candidates by obtaining and defending patents. These risks and uncertainties include the following:
-
-
the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment
and other provisions during the patent process and after a patent has issued. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application,
resulting in partial or complete loss of
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In
addition, Madrigal relies on the protection of its trade secrets and proprietary know-how. Although Madrigal has taken steps to protect its trade secrets and unpatented know-how,
including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants and advisors, Madrigal cannot provide any
assurances that any of these parties would not breach the agreements to disclose any proprietary information, including trade secrets, and Madrigal may not be able to obtain adequate remedies for such
breaches. Further, third parties may still obtain this information by other means, such as breaches of Madrigal's physical or computer security systems. Enforcing a claim that a party illegally
disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. Moreover, third parties may come upon this or similar information lawfully and
independently. Madrigal would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with Madrigal. Further, intellectual property
rights have limitations and do not necessarily address all potential threats to Madrigal's competitive position. If any of these events occurs or if Madrigal otherwise loses protection for its trade
secrets or proprietary know-how, Madrigal's business may be harmed.
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Madrigal may not be able to protect its intellectual property rights throughout the world.
While Madrigal has licensed from Roche issued composition-of-matter patents directed at MGL-3196 in the United States and other
countries, filing, prosecuting and defending patents on MGL-3196 in all countries throughout the world would be prohibitively expensive, and Madrigal's intellectual property rights in some countries
outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries may not protect intellectual property rights to the same extent as
federal and state laws in the United States. Consequently, Madrigal may not be able to prevent third parties from practicing its inventions in all countries outside the United States, or from selling
or importing products made using its inventions in and into the United States or other jurisdictions. Competitors may use Madrigal's technologies in jurisdictions where it has not obtained patent
protection to develop their own products and, further, may export otherwise infringing products to territories where Madrigal has patent protection but enforcement is not as strong as that in the
United States. These products may compete with MGL-3196, and Madrigal's patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many
companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries,
particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it
difficult for Madrigal to stop the infringement of its patents or marketing of competing products in violation of its proprietary rights generally. Proceedings to enforce Madrigal's patent rights in
foreign jurisdictions could result in substantial costs and divert Madrigal's efforts and attention from other aspects of its business, could put its patents at risk of being invalidated or
interpreted narrowly and its patent applications at risk of not issuing, and could provoke third parties to assert claims against Madrigal. Madrigal may not prevail in any lawsuits that it initiates,
and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Madrigal's efforts to enforce its intellectual property rights around the world may be inadequate to
obtain a significant commercial advantage from the intellectual property that it develops or licenses.
Risks Related to Madrigal's Development, Commercialization and Regulatory Approval
If Madrigal is unable to obtain required regulatory approvals, it will be unable to market and sell
its product candidates.
Madrigal's product candidates are subject to extensive governmental regulations relating to development, clinical trials,
manufacturing, oversight of clinical investigators, recordkeeping and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory review and approval process are
required to be successfully completed in the United States and in each foreign jurisdiction in which Madrigal offers its products before a new drug can be sold in such jurisdictions. Satisfaction of
these and other regulatory requirements is costly, time consuming, uncertain, and subject to unanticipated delays. The time required to obtain approval by the FDA, or the regulatory authority in such
other jurisdictions is unpredictable and often exceeds five years following the commencement of clinical trials, depending upon the complexity of the product candidate.
In
connection with the clinical development of its product candidates, Madrigal faces risks that:
-
-
the product candidate may not prove to be safe and efficacious;
-
-
patients may die or suffer serious adverse effects for reasons that may or may not be related to the product candidate being tested;
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-
Madrigal may fail to maintain adequate records of observations and data from its clinical trials, to establish and maintain sufficient
procedures to oversee, collect data from, and manage clinical
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Only
a small percentage of product candidates for which clinical trials are initiated receive approval for commercialization. Furthermore, even if Madrigal does receive regulatory
approval to market a product candidate, any such approval may be subject to limitations such as those on the indicated uses for which Madrigal may market a particular product candidate.
If Madrigal loses key management personnel, or if Madrigal fails to recruit additional highly
skilled personnel, its ability to identify, develop and commercialize products will be impaired.
Madrigal is highly dependent on its current Chief Executive Officer, Rebecca Taub, M.D., who will transition to the role of Chief
Medical Officer and Executive Vice President, Research and Development, of the combined company following the merger. Dr. Taub has significant pharmaceutical industry experience. The loss of
Dr. Taub or any other key member of Madrigal's staff would impair Madrigal's ability to identify, develop and market new products. The loss of the services of these key personnel, or the
inability to attract and retain additional qualified personnel, could result in delays to development or approval, loss of sales and diversion of management resources. In addition, Madrigal depends on
its ability to attract and retain other highly skilled personnel. Competition for qualified personnel is intense, and the process of hiring and integrating such qualified personnel is often lengthy.
Madrigal may be unable to recruit such personnel
on a timely basis, if at all, which would negatively affect Madrigal's development and commercialization programs.
Additionally,
Madrigal does not currently maintain "key person" life insurance on the lives of Dr. Taub or any other key personnel and does not expect to maintain such a policy
for Dr. Taub or Paul A. Friedman, M.D. who is expected to serve as the Chief Executive Officer and Chairman of the combined company following the merger. This lack of insurance means that
Madrigal may not receive adequate compensation for the loss of the services of these individuals.
Madrigal currently has no marketing, sales or distribution infrastructure with respect to its
product candidates. If Madrigal is unable to develop its sales, marketing and distribution capability on its own or through collaborations with marketing partners, Madrigal will not be successful in
commercializing its product candidates.
Madrigal currently has no marketing, sales or distribution capabilities and has limited sales or marketing experience within its
organization. If Madrigal's product candidate, MGL-3196, is approved, Madrigal intends either to establish a sales and marketing organization with technical expertise and supporting distribution
capabilities to commercialize MGL-3196, or to outsource this function to a third party. Either of these options would be expensive and time consuming. Some or all of these costs may be incurred in
advance of any approval of MGL-3196. In addition, Madrigal may not be able to hire a sales force in the United States that is sufficient in size or has adequate expertise in the medical markets that
Madrigal intends to target. Any failure or delay in the development of Madrigal's internal sales, marketing and distribution capabilities would adversely affect the commercialization of MGL-3196 and
other future product candidates.
With
respect to Madrigal's existing and future product candidates, Madrigal may choose to collaborate with third parties that have direct sales forces and established distribution
systems, either to augment its own sales force and distribution systems or as an alternative to Madrigal's own sales force
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and
distribution systems. To the extent that Madrigal enters into co-promotion or other licensing arrangements, Madrigal's product revenue may be lower than if it directly marketed or sold any
approved products. In addition, any revenue Madrigal receives will depend in whole or in part upon the efforts of these third parties, which may not be successful and are generally not within
Madrigal's control. If Madrigal is unable to enter into these arrangements on acceptable terms or at all, Madrigal may not be able to successfully commercialize any approved products. If Madrigal is
not successful in
commercializing any approved products, either on its own or through collaborations with one or more third parties, Madrigal's future product revenue will suffer and it may incur significant additional
losses.
Even if Madrigal obtains FDA approval of MGL-3196 or any other future product candidate, Madrigal or
its partners may never obtain approval or commercialize its products outside of the United States, which would limit Madrigal's ability to realize their full market potential.
In order to market any products outside of the United States, Madrigal must establish and comply with numerous and varying regulatory
requirements of other countries regarding clinical trial design, safety and efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and
regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries and can involve additional product testing and
validation and additional administrative review periods. Seeking foreign regulatory approvals could result in significant delays, difficulties and costs for Madrigal and may require additional
preclinical studies or clinical trials which would be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of
Madrigal's products in those countries. Satisfying these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. In addition, Madrigal's failure to
obtain regulatory approval in any country may delay or have negative effects on the process for regulatory approval in other countries. Madrigal and its partners do not have any product candidates
approved for sale in any jurisdiction, including international markets, and Madrigal does not have experience in obtaining regulatory approval in international markets. If Madrigal or its partners
fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, Madrigal's target market will be reduced and its ability to realize the full market
potential of its products will be harmed.
If Madrigal does not obtain protection under the Hatch-Waxman Amendments and similar foreign
legislation by extending the term of patents covering each of Madrigal's product candidates, Madrigal's business may be materially harmed.
Depending upon the timing, duration and conditions of FDA marketing approval of Madrigal's product candidates, one or more of
Madrigal's United States patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments.
The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and
the FDA regulatory review process. However, Madrigal may not receive an extension if it fails to apply within applicable deadlines, fails to apply prior to expiration of relevant patents or otherwise
fails to satisfy applicable requirements. Moreover, the length of the extension could be less than Madrigal requests. If Madrigal is unable to obtain patent term extension or the term of any such
extension is less than Madrigal requests, the period during which Madrigal can enforce its patent rights for that product may not extend beyond the current patent expiration dates and Madrigal's
competitors may obtain approval
to market competing products sooner. As a result, Madrigal's revenue could be potentially materially reduced.
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If Madrigal or its partners market products in a manner that violates fraud and abuse and other
healthcare laws, or if Madrigal or its partners violate government price reporting laws, Madrigal or its partners may be subject to administrative civil and/or criminal penalties.
In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare laws,
including those commonly referred to as "fraud and abuse" laws, have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. These laws include, among
others, false claims and anti-kickback statutes. At such time, if ever, as Madrigal or any of its partners market any of its future approved products, it is possible that some of the business
activities of Madrigal and/or its partners could be subject to challenge under one or more of these laws.
Federal
false claims, false statements and civil monetary penalties laws prohibit, among others, any person from knowingly presenting, or causing to be presented, a false claim for
payment to the federal government or knowingly making, or causing to be made, a false statement to get a false claim paid. The federal healthcare program anti-kickback statute prohibits, among other
things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any
healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are several statutory exceptions and regulatory safe harbors protecting certain common
activities from prosecution, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to
scrutiny if they do not qualify for an exception or safe harbor.
In
addition, Madrigal and/or its partners may be subject to data privacy and security regulation, including the Health Insurance Portability and Accountability Act of 1996, as amended by
the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, which impose specified requirements relating to the privacy, security and
transmission of individually identifiable health information.
Most
states also have statutes or regulations similar to these federal laws, which may apply to items such as pharmaceutical products and services reimbursed by private insurers.
Madrigal and/or its partners may be subject to administrative, civil and criminal sanctions for violations of any of these federal and state laws. Pharmaceutical and other healthcare companies have
been prosecuted under these laws for a variety of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other monetary benefits to
prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion; and submitting
inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates.
Risks Related to Madrigal's Reliance on Third Parties
If the third parties on which Madrigal relies for the conduct of its clinical trials and results do
not perform Madrigal's clinical trial activities in accordance with good clinical practices and related regulatory requirements, Madrigal may be unable to obtain regulatory approval for or
commercialize its product candidates.
Madrigal uses third-party service providers to conduct and/or oversee the clinical trials of its product candidates and expects to
continue to do so for the foreseeable future. Madrigal relies heavily on these parties for successful execution of its clinical trials. Nonetheless, Madrigal is responsible for confirming that each of
its clinical trials is conducted in accordance with FDA requirements and Madrigal's general investigational plan and protocol.
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The FDA requires Madrigal and its third-party service providers to comply with regulations and standards, commonly referred to as good clinical practices, or GCP,
for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate, and that the trial participants are adequately protected.
Madrigal's reliance on third parties that it does not control does not relieve Madrigal of these responsibilities and requirements. Third parties may not complete activities on schedule or may not
conduct Madrigal's clinical trials in accordance with regulatory or GCP requirements or the respective trial plans and protocols. In addition, third parties may not be able to repeat their past
successes in clinical trials. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of Madrigal product candidates or
result in enforcement action against Madrigal.
Madrigal has relied on, and expects to continue to rely on, third-party manufacturers to produce its
product candidates.
Madrigal does not own or operate manufacturing facilities for the production of clinical or commercial quantities of its product
candidates, and Madrigal lacks the
resources and the capabilities to do so. As a result, Madrigal currently relies, and expects to rely for the foreseeable future, on third-party manufacturers to supply its product candidates. Reliance
on third-party manufacturers entails risks to which Madrigal would not be subject if Madrigal manufactured its product candidates or products itself,
including:
-
-
reliance on third-parties for manufacturing process development, regulatory compliance and quality assurance;
-
-
limitations on supply availability resulting from capacity and scheduling constraints of third-parties;
-
-
the possible breach of manufacturing agreements by third-parties because of factors beyond Madrigal's control; and
-
-
the possible termination or non-renewal of manufacturing agreements by third-parties, at a time that is costly or inconvenient to
Madrigal.
If
Madrigal does not maintain its key manufacturing relationships, Madrigal may fail to find replacement manufacturers or develop its own manufacturing capabilities, which could delay or
impair Madrigal's ability to obtain regulatory approval for its products and substantially increases its costs or deplete profit margins, if any. If Madrigal does find replacement manufacturers,
Madrigal may not be able to enter into agreements with them on terms and conditions favorable to it and there could be a substantial delay before new facilities could be qualified and registered with
the FDA and other foreign regulatory authorities.
The
FDA and other foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding foreign regulators also inspect these facilities to
confirm compliance with current good manufacturing practices, or cGMPs. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays
or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA, European Medicines Agency,
or EMA, and comparable foreign regulatory requirements could adversely affect Madrigal's
clinical research activities and Madrigal's ability to develop its product candidates and market its products following approval.
Madrigal's
current and anticipated future dependence upon others for the manufacture of its product candidates may adversely affect its future profit margins and its ability to develop
its product candidates and commercialize any products that receive regulatory approval on a timely basis.
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Madrigal's reliance on third parties requires it to share its trade secrets, which increases the
possibility that a competitor will discover them or that Madrigal's trade secrets will be misappropriated or disclosed.
Because Madrigal relies on third parties to conduct its clinical trials and to produce its product candidates, Madrigal must, at times,
share trade secrets with them. Madrigal seeks to protect its proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting
agreements or other similar agreements with its third party contractors and consultants prior to disclosing proprietary information. These agreements typically limit the rights of the third parties to
use or disclose Madrigal's confidential information, including its trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other
confidential information increases the risk that such trade secrets become known by Madrigal's competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in
violation of these agreements. Given that Madrigal's proprietary position is based, in part, on its know-how and trade secrets, a competitor's discovery of Madrigal's trade secrets or other
unauthorized use or disclosure would impair Madrigal's competitive position and may have a material adverse effect on its business.
Risks Related to the Combined Company
The combined company will incur losses for the foreseeable future and might never achieve
profitability.
The combined company may never become profitable, even if the combined company is able to complete clinical development for one or more
product candidates and eventually commercialize such product candidates. The combined company will need to successfully complete significant research, development, testing and regulatory compliance
activities that, together with projected general and administrative expenses, is expected to result in substantial increased operating losses for at least the next several years. Even if the combined
company does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis.
The combined company will need to obtain additional funding necessary to support its operations.
Synta and Madrigal do not know when, or if, the combined company will generate any revenue, and both parties do not expect to generate
significant revenue unless and until the combined company obtains regulatory approval of and commercializes one of its current or future product candidates. It is anticipated that the combined company
will continue to incur losses for the foreseeable future, and that losses will increase as the combined company continues the development of, and seeks regulatory approvals for, its product
candidates, and begins to commercialize any approved products. Based upon current operating plans, it is expected the proceeds from Madrigal's private placement, along with net cash held by Synta upon
consummation of the merger, will be able to fund the operations of the combined company through the fourth quarter of 2017. The combined company will require additional capital to complete the
development and commercialization of MGL-3196, if approved, and may also need to raise additional funds to pursue other development activities related to additional product candidates.
Until
such time, if ever, as the combined company can generate substantial revenues, it expects to finance its cash needs through a combination of equity or debt financings,
collaborations, strategic partnerships or licensing arrangements. However, additional capital may not be available on reasonable terms, if at all. To the extent that the combined company raises
additional capital through the sale of stock or convertible debt securities, the ownership interest of its stockholders will be diluted, and the terms of these securities may include liquidation or
other preferences that adversely affect the rights of its common stockholders. Debt financing, if available, may involve agreements that include increased fixed payment obligations and covenants
limiting or restricting the combined company's ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends,
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selling
or licensing intellectual property rights, and other operating restrictions that could adversely affect its ability to conduct its business. If the combined company raises additional funds
through collaborations, strategic partnerships, or licensing arrangements with third parties, it may have to relinquish valuable rights to MGL-3196 or its other product candidates, including its other
technologies, future revenue streams, or research programs, or grant licenses on terms that may not be favorable to it. If the combined company is unable to raise additional funds when needed, it may
be required to delay, limit, reduce, or terminate its product development or future commercialization efforts or grant rights to develop and commercialize MGL-3196 or its other product candidates even
if it would otherwise prefer to develop and commercialize such product candidates itself.
Synta and Madrigal expect Synta's stock price to be volatile, and the market price of its common
stock may drop following the merger.
The market price of Synta common stock following the merger could be subject to significant fluctuations. Market prices for securities
of early-stage pharmaceutical, biopharmaceutical, and other life sciences companies have historically been particularly volatile. Some of the factors that may cause the market price of Synta common
stock to fluctuate include:
-
-
the ability of the combined company to obtain regulatory approvals for MGL-3196 or other product candidates, and delays or failures to
obtain such approvals;
-
-
failure of any of the combined company's product candidates, if approved, to achieve commercial success;
-
-
issues in manufacturing the combined company's approved products, if any, or product candidates;
-
-
the results of the combined company's current and any future clinical trials of its product candidates;
-
-
the entry into, or termination of, key agreements, including key commercial partner agreements;
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-
the initiation of, material developments in, or conclusion of litigation to enforce or defend any of the combined company's
intellectual property rights or defend against the intellectual property rights of others;
-
-
announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant
contracts, commercial relationships or capital commitments;
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-
adverse publicity relating to the NASH markets, including with respect to other products and potential products in such markets;
-
-
adverse publicity relating to the FH markets, including with respect to other products and potential products in such markets;
-
-
the introduction of technological innovations or new therapies that compete with potential products of the combined company;
-
-
the loss of key employees;
-
-
changes in estimates or recommendations by securities analysts, if any, who cover the combined company's common stock;
-
-
general and industry-specific economic conditions that may affect the combined company's research and development expenditures;
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changes in the structure of healthcare payment systems; and
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-
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period-to-period fluctuations in the combined company's financial results.
Moreover,
the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market
fluctuations may also adversely affect the trading price of the combined company's common stock.
In
the past, following periods of volatility in the market price of a company's securities, stockholders have often instituted class action securities litigation against those companies.
Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm the combined company's profitability and
reputation.
The failure to integrate successfully the businesses of Madrigal and Synta in the expected timeframe
could adversely affect the future results of the combined company following the completion of the merger.
The success of the merger will depend, in large part, on the ability of the combined company following the completion of the merger to
realize the anticipated benefits from combining the businesses of Synta and Madrigal. The continued operation of the two companies will be complex.
The
failure to integrate successfully and to manage successfully the challenges presented by the integration process may result in the combined company's failure to achieve some or all
of the anticipated benefits of the merger.
Potential
difficulties that may be encountered in the integration process include the following:
-
-
using the combined company's cash and other assets efficiently to develop the business of Madrigal;
-
-
appropriately managing the liabilities of the combined company;
-
-
potential unknown or currently unquantifiable liabilities associated with the merger and the operations of the combined company;
-
-
potential unknown and unforeseen expenses, delays or regulatory conditions associated with the merger; and
-
-
performance shortfalls at one or both of the companies as a result of the diversion of management's attention caused by completing the
merger and integrating the companies' operations.
The combined company will incur costs and demands upon management as a result of complying with the
laws and regulations affecting public companies.
The combined company will incur significant legal, accounting and other expenses that Madrigal did not incur as a private company,
including costs associated with public company reporting requirements. The combined company will also incur costs associated with corporate governance requirements, including requirements under the
Sarbanes-Oxley Act and rules and regulations promulgated by the SEC and The NASDAQ Stock Market. These rules and regulations are expected to increase the combined company's legal and financial
compliance costs and to make some activities more time-consuming and costly. For example, not all members of the combined company's management team have previously managed and operated a public
company. The executive officers and other personnel of the combined company will need to devote substantial time to gaining expertise regarding operations as a public company and compliance with
applicable laws and regulations. These rules and regulations may also make it difficult and expensive for the combined company to obtain directors' and officers' liability insurance. As a result, it
may be more difficult for the combined company to attract and retain qualified individuals to serve on the combined company's board of directors or as executive officers of the combined company, which
may adversely affect investor
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confidence
in the combined company and could cause the combined company's business or stock price to suffer.
Anti-takeover provisions in the combined company's charter documents and under Delaware law could
make an acquisition of the combined company more difficult and may prevent attempts by the combined company stockholders to replace or remove the combined company management.
Provisions in the combined company's certificate of incorporation and bylaws, which are identical to Synta's certificate of
incorporation and bylaws, may delay or prevent an
acquisition or a change in management. These provisions include a classified board of directors. In addition, because the combined company will be incorporated in Delaware, it is governed by the
provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of the outstanding combined company voting stock from merging or combining with the combined company.
Although Synta and Madrigal believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with the combined company's board
of directors, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by the combined company's
stockholders to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors, which is responsible for appointing members of
management.
Synta and Madrigal do not anticipate that the combined company will pay any cash dividends in the
foreseeable future.
The current expectation is that the combined company will retain its future earnings to fund the development and growth of the combined
company's business. As a result, capital appreciation, if any, of the common stock of the combined company will be your sole source of gain, if any, for the foreseeable future.
The pro forma financial statements are presented for illustrative purposes only and may not be an
indication of the combined company's financial condition or results of operations following the completion of the merger.
The pro forma financial statements contained in this proxy statement are presented for illustrative purposes only and may not be an
indication of the combined company's financial condition or results of operations following the merger for several reasons. The pro forma financial statements have been derived from the historical
financial statements of Synta and Madrigal and adjustments and assumptions have been made regarding the combined company after giving effect to the merger. The information upon which these adjustments
and assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with accuracy. Moreover, the pro forma financial statements do not reflect all costs
that are expected to be incurred by the combined company in connection with the merger. For example, the impact of any incremental costs incurred in integrating the two companies is not reflected in
the pro forma financial statements. As a result, the actual financial condition of the combined company following the merger may not be consistent with, or evident from, these pro forma financial
statements. The assumptions used in preparing the pro forma financial information may not prove to be accurate, and other factors may affect the combined company's financial condition following the
transaction. See "Unaudited Pro Forma Condensed Combined Financial Statements" beginning on page 226 of this proxy statement.
Future sales of shares by existing stockholders could cause the combined company's stock price to
decline.
If existing stockholders of Synta and Madrigal sell, or indicate an intention to sell, substantial amounts of the combined company's
common stock in the public market after the post-merger lock-up and other legal restrictions on resale discussed in this proxy statement lapse, the trading price of the common stock of the combined
company could decline. Upon completion of the merger, the combined
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company
is expected to have outstanding a total of approximately 396.7 million shares of common stock. As of immediately following the closing of the merger, approximately 117.7 million
shares of common stock will be freely tradable, without restriction, in the public market.
The
lock-up agreements entered into between each of Synta and Madrigal and certain of each other's securityholders provide that the shares subject to the lock-up restrictions will be
released from such restrictions 180 days from the closing date of the merger. Based on shares outstanding as of April 13, 2016 and assuming that a registration statement covering the
resale of the shares of Synta common stock issuable in connection with the merger is in effect, up to an additional approximately 253.9 million shares of common stock will be eligible for sale
in the public market. Nearly all of these shares will be held by directors, executive officers of the combined company and other affiliates and will be subject to volume limitations under
Rule 144 under the Securities Act.
The ownership of the combined company's capital stock will be highly concentrated, which may prevent
other stockholders from influencing significant corporate decisions and may result in conflicts of interest that could cause the combined company's stock price to decline.
Investment entities and individuals affiliated with Bay City Capital, LLC, or Bay City Capital, of which Dr. Craves, an
anticipated director of the combined company, is a managing director, are expected to beneficially own or control approximately 52.5% of the outstanding shares of the combined company's outstanding
common stock following the completion of the merger. Accordingly, Bay City Capital will exert substantial influence over the combined company and the outcome of corporate actions requiring stockholder
approval, including the election of directors, any merger, consolidation or sale of all or substantially all of the combined company's assets or any other significant corporate transactions. This
stockholder may also delay or prevent a change of control of the combined company, even if such a change of control would benefit the other stockholders of the
combined company. The significant concentration of stock ownership may adversely affect the trading price of the combined company's capital stock due to investors' perception that conflicts of
interest may exist or arise.
Even if the combined company's product candidates are successful in clinical trials, the combined
company may not be able to successfully commercialize them, which may adversely affect the combined company's future revenues and financial condition.
Madrigal has dedicated substantially all of its resources to the research and development of its product candidates. At present,
Madrigal is focusing its resources on MGL-3196 while strategically conducting development activities on the remainder of its other future product candidates. Madrigal's primary product candidate,
MGL-3196, is currently in the early stages of clinical development. The combined company may not develop any product candidates suitable for commercialization.
Prior
to commercialization, each product candidate will require significant additional research, development and preclinical testing and extensive clinical investigation before
submission of any regulatory application for marketing approval. Potential products that appear to be promising at early stages of development may not reach the market for a number of reasons,
including that they may:
-
-
be found ineffective or cause harmful side effects during clinical trials;
-
-
fail to receive necessary regulatory approvals;
-
-
be difficult to manufacture on a large scale;
-
-
be uneconomical to produce;
-
-
fail to achieve market acceptance; or
-
-
be precluded from commercialization by proprietary rights of third parties.
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The
combined company's product development efforts or the combined company's collaborative partners' efforts may not be successfully completed for any product candidate, and the combined
company may not obtain any required regulatory approvals or successfully commercialize a product candidate even if clinical development for such product candidate is successfully completed. Any
products, if introduced, may not be successfully marketed nor achieve customer acceptance, which may adversely affect the combined company's future revenues and financial condition.
Because the merger will result in an ownership change under Section 382 of the Internal
Revenue Code, or the Code, for Synta, Synta's pre-merger net operating loss carryforwards and certain other tax attributes will be subject to limitations. The net operating loss carryforwards and
other tax attributes of Madrigal and of the combined company may also be subject to limitations as a result of ownership changes.
If a corporation undergoes an "ownership change" within the meaning of Section 382 of the Code, the corporation's net operating
loss carryforwards and certain other tax attributes arising from before the ownership change are subject to limitations on use after the ownership change. In general, an ownership change occurs if
there is a cumulative change in the corporation's equity ownership by certain stockholders that exceeds fifty percentage points over a rolling three-year period. Similar rules may apply under state
tax laws. The merger will result in an ownership change for Synta and, accordingly, Synta's net operating loss carryforwards and certain other tax attributes will be subject to limitations (or
disallowance) on their use after the merger. Madrigal's net operating loss carryforwards may also be subject to limitation as a result of prior shifts in equity ownership and/or the merger. Additional
ownership changes in the future could result in additional
limitations on Synta's, Madrigal's and the combined company's net operating loss carryforwards. Consequently, even if the combined company achieves profitability, it may not be able to utilize a
material portion of Synta's, Madrigal's or the combined company's net operating loss carryforwards and other tax attributes, which could have a material adverse effect on cash flow and results of
operations.
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FORWARD-LOOKING STATEMENTS
This proxy statement and the documents incorporated by reference into this proxy statement contain forward-looking statements relating
to Synta, Madrigal and the merger. These forward-looking statements are based on current expectations and beliefs and involve numerous risks and uncertainties that could cause actual results to differ
materially from expectations. These forward-looking statements should not be relied upon as predictions of future events as we cannot assure you that the events or circumstances reflected in these
statements will be achieved or will occur. You can identify forward-looking statements by the use of forward-looking terminology including "believes," "expects," "may," "will," "should," "seeks,"
"intends," "plans," "pro forma," "estimates," or "anticipates" or the negative of these words and phrases or other variations of these words and phrases or comparable terminology. All statements other
than statements of historical fact are statements that could be deemed forward-looking statements. For example, forward-looking statements include any statements regarding the strategies, prospects,
plans, expectations or objectives of management of Synta or Madrigal for future operations, the progress, scope or duration of the development of product candidates or programs, the benefits that may
be derived from product candidates or the commercial or market opportunity in any target indication, the ability of Synta or Madrigal to protect intellectual
property rights, the anticipated operations, financial position, revenues, costs or expenses of Synta, Madrigal or the combined company, statements regarding future economic conditions or performance,
statements of belief and any statement of assumptions underlying any of the foregoing. Forward looking statements may also include any statements regarding the approval and closing of the merger,
including the timing of the merger, Synta's ability to solicit a sufficient number of proxies to approve the merger, other conditions to the completion of the merger, the expected benefits of the
merger, and any statement of assumptions underlying any of the foregoing.
For
a discussion of the factors that may cause Synta, Madrigal or the combined company's actual results, performance or achievements to differ materially from any future results,
performance or achievements expressed or implied in such forward-looking statements, or for a discussion of risk associated with the ability of Synta and Madrigal to complete the merger and the effect
of the merger on the business of Synta, Madrigal and the combined company, see "Risk Factors" beginning on page 26. Additional factors that could cause actual results to differ materially from
those expressed in the forward-looking statements are discussed in reports filed with the SEC by Synta. See "Where You Can Find More Information" beginning on page 247. There can be no
assurance that the merger will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of the merger will be realized.
If any of these risks or uncertainties materializes or any of these assumptions proves incorrect, the results of Synta, Madrigal or the combined company could
differ materially from the forward-looking statements. All forward-looking statements in this proxy statement are current only as of the date on which the statements were made. Synta and Madrigal do
not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any statement is made or to reflect the occurrence of
unanticipated events.
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THE ANNUAL MEETING OF SYNTA STOCKHOLDERS
Date, Time and Place
The Annual Meeting will be held on July 21, 2016, at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One
Financial Center, Boston, MA 02111, commencing at 9:00 am, local time. Synta is sending this proxy statement to its stockholders in connection with the solicitation of proxies by the Synta board of
directors for use at the Annual meeting and any adjournments or postponements of the Annual Meeting. This proxy statement is first being sent to stockholders of Synta on or about June 13, 2016.
Purposes of the Annual Meeting
The purposes of the Annual Meeting are:
-
1)
-
To
approve the Merger Agreement, by and among Synta, Saffron Merger Sub and Madrigal, a copy of which is attached as Annex A to this proxy statement,
and the issuance of shares of Synta common stock to Madrigal stockholders by virtue of the merger contemplated by the Merger Agreement;
-
2)
-
To
approve a certificate of amendment to Synta's restated certificate of incorporation to effect a reverse stock split of Synta's issued and outstanding
shares of common stock, in the form attached as Annex C to the accompanying proxy statement pursuant to which any whole number of outstanding shares between and including twenty (20) and
thirty-five (35), such whole number to be determined by the Synta board of directors, would be combined and reclassified into one share of Synta common stock;
-
3)
-
To
approve an amendment to the 2015 Stock Plan to increase the total number of shares of Synta common stock currently available for issuance under the 2015
Stock Plan by 40,000,000 shares prior to giving effect to the proposed reverse stock split, in the form attached as Annex D to this proxy statement;
-
4)
-
To
elect one Class III director to Synta's board of directors for a term of three years, provided, however, that if the merger is completed, the Synta
board of directors will be reconstituted as provided in the Merger Agreement;
-
5)
-
To
approve, on an advisory basis, the compensation of Synta's named executive officers as disclosed in this proxy statement, pursuant to the compensation
disclosure rules of the SEC;
-
6)
-
To
approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to Synta's named executive officers as disclosed in
this proxy statement;
-
7)
-
To
ratify the appointment of Ernst & Young LLP as Synta's independent registered public accounting firm for the fiscal year ending
December 31, 2016;
-
8)
-
To
consider and vote on a proposal to adjourn the Annual Meeting, if necessary, to solicit additional proxies, in the event that there are not sufficient
votes at the time of the Annual Meeting to approve Proposal Nos. 1, 2 and 3; and
-
9)
-
To
consider such other business as may properly come before the stockholders at the Annual Meeting or any adjournment or postponement thereof.
Proposal
Nos. 1 and 2 are being submitted to stockholders pursuant to the terms of the Merger Agreement. Proposal No. 3 is conditioned upon the approval of Proposal
Nos. 1 and 2.
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Recommendation of the Synta Board of Directors
The Synta board of directors has determined and believes that the Merger Agreement and the issuance of shares of Synta common stock by
virtue of the merger is advisable to and in the best interests of, Synta and its stockholders and has approved such items. The Synta board of directors unanimously recommends that Synta stockholders
vote "FOR" Proposal No. 1 to approve the Merger Agreement and the issuance of shares of Synta common stock by virtue of the merger.
The
Synta board of directors has determined and believes that it is advisable to, and in the best interests of, Synta and its stockholders to approve the amendment to the restated
certificate of incorporation of Synta effecting the proposed reverse stock split, as described in this proxy statement. The Synta board of directors unanimously recommends that Synta stockholders vote
"FOR" Proposal No. 2 to approve the amendment to the restated certificate of incorporation of Synta effecting the proposed reverse stock split, as described in this proxy statement.
The
Synta board of directors has determined and believes that it is advisable to, and in the best interests of, Synta and its stockholders to approve the amendment to the 2015 Stock Plan
to increase the total number of shares of Synta common stock currently available for issuance under the 2015 Stock Plan, as described in this proxy statement. The Synta board of directors unanimously
recommends that Synta stockholders vote "FOR" Proposal No. 3 to approve the amendment to the 2015 Stock Plan to increase the total number of shares of Synta common stock currently available for
issuance under the 2015 Stock Plan, as described in this proxy statement.
The
Synta board of directors has determined and believes that the election of Bruce Kovner as a Class III director for a three-year term to expire at the 2019 Synta annual
stockholders meeting is advisable to, and in the best interests of, Synta and its stockholders and has approved and adopted the proposal. The Synta board of directors unanimously recommends that Synta
stockholders vote "FOR" Proposal No. 4 to elect one Class III director, Bruce Kovner, for a three-year term to expire at the 2019 Synta annual stockholders meeting provided, however,
that, if the merger is completed, the Synta board of directors will be reconstituted as provided in the Merger Agreement.
The
Synta board of directors has determined and believes that it is advisable to, and in the best interests of, Synta and its stockholders to approve, on an advisory basis, the
compensation of Synta's named executive officers. The Synta board of directors unanimously recommends that Synta stockholders vote "FOR" Proposal No. 5 to approve the compensation of Synta's
named executive officers as disclosed in this proxy statement.
The
Synta board of directors has determined and believes that it is advisable to, and in the best interests of, Synta and its stockholders to approve, on an advisory basis, the golden
parachute compensation that may be paid or become payable to Synta's named executive officers. The Synta board of directors unanimously recommends that Synta stockholders vote "FOR" Proposal
No. 6 to approve the golden parachute compensation of Synta's named executive officers as disclosed in this proxy statement.
The
Synta board of directors has determined and believes that the ratification of the selection of Ernst & Young LLP as Synta's independent registered public accounting
firm for the fiscal year ending December 31, 2016 is advisable to, and in the best interests of, Synta and its stockholders and has approved such ratification. The Synta board of directors
unanimously recommends that Synta stockholders vote "FOR" Proposal No. 7 to ratify the selection of Ernst & Young LLP as Synta's independent registered public accounting firm for
the fiscal year ending December 31, 2016.
The
Synta board of directors has determined and believes that adjourning the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of
Proposal Nos. 1, 2 and 3 is advisable to, and in the best interests of, Synta and its stockholders and has approved and adopted the proposal. The Synta board of directors unanimously recommends
that Synta stockholders vote
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"FOR"
Proposal No. 8 to adjourn the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 and 3.
Record Date and Voting Power
Only holders of record of Synta common stock at the close of business on the record date, May 31, 2016, are entitled to notice
of, and to vote at, the Annual Meeting. There were approximately 39 holders of record of Synta common stock at the close of business on the record date. At the close of business on the record date,
137,806,441 shares of Synta common stock were issued and outstanding. Each share of Synta common stock entitles the holder thereof to one vote on each matter submitted for stockholder approval. See
the section entitled "Principal Stockholders of Synta" beginning on page 239 for information regarding persons known to the management of Synta to be the beneficial owners of more than 5% of
the outstanding shares of Synta common stock.
Voting and Revocation of Proxies
The proxy accompanying this proxy statement is solicited on behalf of the board of directors of Synta for use at the Annual Meeting.
If
you are a stockholder of record of Synta as of the record date referred to above, you may vote in person at the Annual Meeting or vote by proxy using the enclosed proxy card. Whether
or not you plan to attend the Annual Meeting, Synta urges you to vote by proxy to ensure your vote is counted. You may still attend the Annual Meeting and vote in person if you have already voted by
proxy. As a stockholder of record you may vote:
-
-
By
mail.
If you received a proxy card by mail, you can vote by mail by completing, signing, dating and returning the proxy card as
instructed on the card. Your proxy will be voted in accordance with your instructions. If you sign the proxy card but do not specify how you want your shares voted, they will be voted as recommended
by Synta's board of directors below.
-
-
By Internet or by
telephone.
Follow the instructions on the proxy card to vote by Internet or telephone.
-
-
In person at the
meeting.
If you attend the meeting, you may deliver your completed proxy card in person or you may vote by completing a ballot, which
will be available at the meeting.
Telephone
and Internet voting facilities for stockholders of record will be available 24-hours a day and will close at 1:00 a.m., Central Time, on July 21, 2016.
If
your Synta shares are held by your broker as your nominee, that is, in "street name," you should receive voting instructions from the bank, broker or other nominee that holds your
shares. If you do
not give instructions to your broker, your broker can vote your Synta shares with respect to "discretionary" items but not with respect to "non-discretionary" items. Discretionary items are proposals
considered routine under the rules of The New York Stock Exchange on which your broker may vote shares held in "street name" in the absence of your voting instructions. On non-discretionary items for
which you do not give your broker instructions, the Synta shares will be treated as broker non-votes.
-
-
To vote by mail, you should follow the instructions included on that proxy card regarding how to instruct your broker to vote your
Synta shares.
-
-
To vote in person at the meeting, you will need to contact the bank, broker or other nominee that is the stockholder of record for
your shares to obtain a broker's proxy card and then bring the proxy card, an account statement or a letter from the stockholder of record indicating that you beneficially owned the shares as of the
record date and a form of government issued picture identification to the meeting. If you have all of (1) a broker's proxy card, (2) an account
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statement
or letter indicating beneficial ownership as of the record date and (3) a government issued picture identification, you may vote by completing a paper proxy card or a ballot, which
will be available at the meeting. If not, you will not be able to vote at the meeting.
-
-
To vote over the Internet or by telephone, if you are permitted and wish to do so, you should receive instructions from your bank,
broker or other nominee and follow those instructions.
All
properly executed proxies that are not revoked will be voted at the Annual Meeting and at any adjournments or postponements of the Annual Meeting in accordance with the instructions
contained in the proxy. If a holder of Synta common stock executes and returns a proxy and does not specify otherwise, the shares represented by that proxy will be voted "FOR" Proposal No. 1 to
approve the Merger Agreement and the issuance of shares of Synta common stock in the merger; "FOR" Proposal No. 2 to approve the amendment to the restated certificate of incorporation of Synta
effecting the proposed reverse stock split described in this proxy statement; "FOR" Proposal No. 3 to approve the amendment to the 2015 Stock Plan to increase the total number of shares of
Synta common stock currently available for issuance; "FOR" Proposal No. 4 to elect Bruce Kovner as a Class III director for a three-year term to expire at the 2019 Synta annual
stockholders meeting, provided, however, that, if the merger is completed, the Synta board of directors will be reconstituted as provided in the Merger Agreement; "FOR" Proposal No. 5 to
approve, on an advisory basis, the compensation of Synta's named executive officers; "FOR" Proposal No. 6 to approve, on an advisory basis, the golden parachute compensation that may be paid or
become payable to Synta's named executive officers; "FOR" Proposal No. 7 to ratify the selection of Ernst & Young LLP as Synta's independent registered public accounting firm for
the year ending December 31, 2016; and "FOR" Proposal No. 8 to adjourn the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of
Proposal Nos. 1, 2 and 3 in accordance with the recommendation of the Synta board of directors.
Unless
you are a Synta stockholder who executed a voting agreement, you may change your vote or revoke your proxy at any time before your proxy is voted at the Annual Meeting in any one
of the following ways:
-
-
if you have signed and returned a paper proxy card, by signing a new proxy card bearing a later date and submitting it as instructed
above;
-
-
if you have voted by Internet or telephone, by casting a new vote over the Internet or by telephone as instructed above;
-
-
by notifying Synta's Corporate Secretary in writing before the Annual Meeting that you have revoked your proxy; or
-
-
by attending the meeting in person and voting in person as provided above. Merely attending the meeting in person is not sufficient to
revoke a previously submitted proxy. You must specifically request at the meeting that it be revoked.
The
vote that you submit latest and still timely is the vote that will be counted.
If
you are a Synta stockholder of record or a stockholder who owns Synta shares in "street name" and have instructed a broker to vote your shares of Synta common stock, you must follow
directions received from your broker to change your vote or revoke your proxy.
Required Vote
The presence, in person or represented by proxy, at the Annual Meeting of the holders of a majority of the shares of Synta common stock
outstanding and entitled to vote at the Annual Meeting is necessary to constitute a quorum at the meeting. Abstentions and broker non-votes will be counted towards a quorum. Approval of Proposal
Nos. 1 (with abstentions having the same effect as votes against Proposal No. 1), 3, 5, 6, 7 and 8 requires the affirmative vote of the holders of a majority of the
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shares
of Synta common stock present in person or represented by proxy at the Annual Meeting and entitled to vote on the proposal. Approval of Proposal No. 2 requires the affirmative vote of
holders of a majority of the Synta common stock outstanding on the record date for the Annual Meeting. For Proposal No. 4, directors are elected by a plurality of the affirmative votes cast by
those shares present in person, or represented by proxy, and entitled to vote at the Annual Meeting. The nominees for director receiving the highest number of affirmative votes will be elected.
Votes
will be counted by the inspector of election appointed for the meeting, who will separately count "FOR" and "AGAINST" votes, abstentions and broker non-votes. Abstentions will be
counted towards the vote total for each proposal and will have the same effect as "AGAINST" votes for Proposal Nos. 1 and 2, but will have no effect on Proposal Nos. 3, 4, 5, 6, 7 and 8.
Broker non-votes will have the same
effect as "AGAINST" votes for Proposal No. 2, but will have no effect on Proposal Nos. 1, 3, 4, 5, 6, 7 and 8.
The
directors, executive officers and several major stockholders of Synta, owning a combined 18.2% of the shares of Synta common stock entitled to vote at the Annual Meeting, are subject
to voting agreements. Each stockholder that entered into a voting agreement has agreed to vote all shares of Synta common stock owned by such stockholders as of the record date in favor of the
issuance of Synta common stock in the merger as contemplated by the Merger Agreement, the adoption of the Merger Agreement if submitted for adoption, the approval of any proposal to adjourn or
postpone the meeting to a later date, if there are not sufficient votes for the issuance of Synta as contemplated by the Merger Agreement on the date on which such meeting is held, and any other
matter necessary to complete the transactions contemplated by the Merger Agreement that are considered and voted upon by Synta's stockholders and against any "acquisition proposal," as defined in the
Merger Agreement. Synta and Madrigal are not aware of any affiliate of Madrigal, other than Drs. Friedman and Taub, owning any shares of Synta common stock entitled to vote at the Annual Meeting.
Solicitation of Proxies
In addition to solicitation by mail, the directors, officers, employees and agents of Synta may solicit proxies from Synta stockholders
by personal interview, telephone, telegram or otherwise. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Synta common stock
for the forwarding of solicitation materials to the beneficial owners of Synta common stock. Synta will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket
expenses they incur in connection with the forwarding of solicitation materials. We have engaged The Proxy Advisory Group, LLC to advise us on certain proposals in this proxy statement. We have
engaged The Proxy Advisory Group, LLC to assist in the solicitation of proxies and provide related advice and informational support, for a services fee and the reimbursement of customary
disbursements that are not expected to exceed $25,000 in the aggregate.
Report of Audit Committee
The audit committee of the Synta's board of directors, which consists entirely of directors who meet the independence and experience
requirements of The NASDAQ Stock Market, has furnished the following report:
The
audit committee assists the Board in overseeing and monitoring the integrity of our financial reporting process, compliance with legal and regulatory requirements and the quality of
internal and external audit processes. This committee's role and responsibilities are set forth in a charter adopted by the Board, which is available on our website at www.syntapharma.com. This
committee reviews and reassesses our charter annually and recommends any changes to the Board for approval. The audit committee is responsible for overseeing our overall financial reporting process,
and for the appointment, compensation, retention, and oversight of the work of our independent registered public accounting firm. In fulfilling its responsibilities for the financial statements for
the fiscal year ended December 31, 2015, the audit committee took the following actions:
-
-
Reviewed and discussed the audited financial statements for the fiscal year ended December 31, 2015 with management and
Ernst & Young LLP, our independent registered public accounting firm;
-
-
Discussed with Ernst & Young LLP the matters required to be discussed in accordance with Auditing Standard No
16-
Communications with Audit Committees
; and
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-
-
Received written disclosures and the letter from Ernst & Young LLP regarding its independence as required by the
applicable requirements of the Public Company Accounting Oversight Board regarding Ernst &Young LLP's communications with the audit committee and the audit committee further discussed
with Ernst & Young LLP their independence. The audit committee also considered the status of pending litigation, taxation matters and other areas of oversight relating to the financial
reporting and audit process that the committee determined appropriate.
Based
on the audit committee's review of the audited financial statements and discussions with management and Ernst & Young LLP, the audit committee recommended to the
Board that the audited financial statements be included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 for filing with the SEC.
|
|
|
|
|
MEMBERS OF THE AUDIT COMMITTEE
|
|
|
William S. Reardon, C.P.A. (Chairman)
Keith R. Gollust
Robert N. Wilson
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Vote Required
The affirmative vote of a majority of the shares cast affirmatively or negatively at the Annual Meeting is required to ratify the
appointment of the independent registered public accounting firm.
If
Synta's stockholders ratify the selection of Ernst & Young LLP, the audit committee may still, in its discretion, decide to appoint a different independent registered
public accounting firm at any time during the year ending December 31, 2016, if it concludes that such a change would be in the best interests of Synta and its stockholders. If Synta's
stockholders fail to ratify the selection, the Audit Committee will reconsider, but not necessarily rescind, the appointment.
THE SYNTA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT SYNTA STOCKHOLDERS VOTE "FOR" RATIFICATION OF THE APPOINTMENT OF ERNST & YOUNG LLP AS OUR
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM, AND PROXIES SOLICITED BY THE BOARD WILL BE VOTED IN ACCORDANCE WITH THE BOARD'S RECOMMENDATION UNLESS A STOCKHOLDER INDICATES OTHERWISE ON THE
PROXY.
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PROPOSAL NO. 8:
APPROVAL OF POSSIBLE ADJOURNMENT OF THE ANNUAL MEETING
If Synta fails to receive a sufficient number of votes to approve Proposal Nos. 1, 2 and 3, Synta may propose to adjourn the
Annual Meeting for a period of not more than 30 days, for the purpose of soliciting additional proxies to approve Proposal Nos. 1, 2 and 3. Synta currently does not intend to propose
adjournment at the Annual Meeting if there are sufficient votes to approve Proposal Nos. 1, 2 and 3.
Vote Required
The affirmative vote of a majority of the shares of Synta common stock present in person or represented by proxy at the Annual Meeting
and entitled to vote on the proposal is required to adjourn the Annual Meeting for the purpose of soliciting additional proxies to approve Proposal Nos. 1, 2 and 3.
Recommendation of Synta Board of Directors
THE SYNTA BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT SYNTA STOCKHOLDERS VOTE "FOR" THE POSSIBLE ADJOURNMENT
OF THE ANNUAL MEETING, IF NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF PROPOSAL NOS. 1, 2 AND 3. EACH OF PROPOSAL NOS. 1, 2 AND 3 ARE CONDITIONED UPON EACH
OTHER AND THE APPROVAL OF EACH SUCH PROPOSAL IS REQUIRED TO CONSUMMATE THE MERGER.
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SYNTA BUSINESS
Overview
Synta Pharmaceuticals Corp., or Synta is a company that has been historically focused on research, development and commercialization of
novel oncology medicines that have the potential to change the lives of cancer patients. In October 2015, we announced the decision to terminate for futility the Phase 3 GALAXY-2 trial of our
novel heat shock protein 90 (Hsp90) inhibitor, ganetespib, and docetaxel in the second-line treatment of patients with advanced non-small
cell lung adenocarcinoma. Based on the review of a pre-planned interim analysis, the study's Independent Data Monitoring Committee concluded that the addition of ganetespib to docetaxel was unlikely
to demonstrate a statistically significant improvement in overall survival, the primary endpoint of the study, compared to docetaxel alone.
We
have also been evaluating several candidates from our proprietary Hsp90 inhibitor Drug Conjugate, or HDC, program, which leverages the preferential accumulation of Hsp90 inhibitors in
tumors to selectively deliver a wide array of anti-cancer payloads. We are currently conducting preclinical studies for our first clinical candidate from the HDC program, STA-12-8666, in anticipation
of potentially submitting an investigational new drug application, or IND, for STA-12-8666. While we have determined not to pursue an IND submission for STA-12-8666 in the immediate future, we may
determine to do so at a later date.
Following
termination of the GALAXY-2 trial in October 2015, we initiated a comprehensive review of our strategy. In November 2015, we committed to a restructuring that consisted
primarily of a workforce reduction to better align our workforce to our revised operating plans, which included support of key ongoing ganetespib investigator-sponsored studies and continued effort on
the development of candidates from our HDC program, in particular our lead HDC candidate, STA-12-8666. As announced in March 2016, in order to conserve cash while we continue to evaluate strategic
alternatives to maximize value for stockholders, we committed to a further restructuring in February 2016 that consisted primarily of a workforce reduction of 23 positions, including 19 research and
development positions, to a total of 10 remaining positions. In connection with this restructuring, we discontinued a substantial portion of our research and development activities. We continue to
conduct limited activities with respect to ganetespib and the drug candidates from our HDC program, including STA-12-8666, as detailed below.
We
currently do not have any drugs that are commercially available and none of our drug candidates have obtained the approval of the U.S. Food and Drug Administration, or FDA, or any
similar foreign regulatory authority.
We
have a clinical-stage drug candidate in oncology (ganetespib) and a novel, proprietary small molecule cancer drug development program (the HDC program).
Ganetespib (Hsp90 Inhibitor)
Summary
Ganetespib is a novel, potent, small molecule inhibitor of Hsp90, a molecular chaperone which is required for the proper folding and
activation of many cancer-promoting proteins. Inhibition of Hsp90 by ganetespib leads to the simultaneous degradation of many of these client proteins and the subsequent death or cell cycle arrest of
cancer cells dependent on those proteins. A number of Hsp90 client proteins are also involved in the resistance of cancer cells to other anti-cancer treatments, such as chemotherapy. The ability to
reduce cancer-cell drug resistance suggests that the combination of ganetespib with chemotherapies or other anti-cancer agents may provide greater benefit than those agents administered alone. In
preclinical studies, ganetespib has shown potent anti-cancer activity against a broad range of solid and hematologic cancers, both as a monotherapy and in combination
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with
a variety of anti-cancer treatment approaches including chemotherapy, radiation, targeted therapy and immunotherapy.
Ganetespib Mechanism of Action
Hsp90 is required for the structural and functional maturation of numerous client proteins, many of which play critical roles in cell
growth, differentiation and survival. Preclinical results have shown that ganetespib is a selective inhibitor of Hsp90. Relative to their normal counterparts, cancer cells are more reliant on the
active Hsp90 complex. Recent published work has shown that cancer cells overexpress a modified form of Hsp90 that preferentially binds Hsp90 inhibitors. This preferential binding provides a possible
explanation for the observed anticancer activity and lack of severe toxicity of Hsp90 inhibitors.
Ongoing Ganetespib Clinical Trials
We plan to continue to support the clinical trials in ovarian cancer and sarcoma described below by providing ganetespib drug supply
and required safety and regulatory oversight until each of these respective studies conclude. We are also currently conducting limited preclinical activities with ganetespib.
GANNET53 TrialGanetespib in ovarian cancer
GANNET53, a Seventh Framework Programme (FP7) research project funded by the European Commission, is a pan-European randomized trial
designed to evaluate the combination of ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients with metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer. Preclinical
models have shown that mutant p53 is critical to the growth and proliferation of these cancers. Many mutations render p53 unable to fold appropriately, leaving the protein highly dependent on Hsp90
for stability. Inhibition of Hsp90 destroys the complex between Hsp90 and mutant p53, leading to the degradation of the protein and cancer cell death. We believe this hypothesized mechanism is further
supported by results detailed in a July 2015 Nature publication, Improving survival by exploiting tumor dependence on stabilized mutant p53 for treatment, by E.M. Alexandrova, et al. Mice harboring
mutant p53 treated with ganetespib had prolonged survival as compared to treated p53 null mice, and this activity is correlated with degradation of mutant p53 and tumor apoptosis. In the aggregate, we
believe these data suggest the potential of mutated p53 to serve as a predictive biomarker for Hsp90 inhibitors such as ganetespib.
Hsp90
inhibition has also been shown to sensitize mutant p53 cancer cells to treatment with chemotherapies, as has been seen in preclinical studies evaluating ganetespib in other tumor
types, supporting the planned trial design evaluating the combination of ganetespib and paclitaxel vs. paclitaxel alone.
Enrollment
of the safety lead-in Phase 1 portion of GANNET53 in centers in Austria, Belgium, France, and Germany began in July 2014 and is now complete. Initial results from the
Phase 1 portion were presented in June 2015 at the American Society of Clinical Oncology (ASCO) Annual Meeting, and these results demonstrated the feasibility and tolerability of combining
ganetespib and paclitaxel in this treatment setting. In June 2015, we announced that the first patient was enrolled into the randomized Phase 2 portion of the trial.
We
expect that enrollment in the Phase 2 portion of this trial will continue and be completed in 2017; however, as GANNET53 is an investigator-sponsored trial, we do not
ultimately control the enrollment timeline for the study.
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SARC 023Ganetespib in Sarcoma
SARC 023, a clinical trial sponsored by the Sarcoma Alliance for Research through Collaboration (SARC), is an open label Phase 1/2
clinical trial of ganetespib in combination with the mTOR inhibitor sirolimus in patients with refractory sarcoma, including malignant peripheral nerve sheath tumors (MPNSTs). The Pediatric
Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) reviewed the design of SARC 023, as well as pre-clinical data demonstrating the scientific rationale for studying this combination in a
clinical trial. The Phase 1 portion of the clinical trial, which is currently ongoing, is designed to assess the safety, tolerability, and maximum tolerated/recommended dose of the combination.
We
expect completion of enrollment in the Phase 1 portion of this clinical trial to occur in 2017; however, as SARC 023 is an investigator-sponsored trial, we do not ultimately
control the enrollment timeline for the study.
Our
expectation is that no additional patients will be enrolled on ganetespib containing treatment arms of clinical studies other than the ovarian cancer and sarcoma trials described
above. Our intent is to wind down the ganetespib containing arms in all other remaining investigator-sponsored trials by mid-2016.
HDC Program
In September 2013, we announced the launch of a novel, proprietary small molecule cancer drug development program: Hsp90 inhibitor drug
conjugate, or HDC, program.
Our
HDC program is based on the observation that small molecule inhibitors of Hsp90 are retained in tumors for as much as 20 times longer than in blood or normal tissue. Preclinical
experiments have shown that following intravenous administration in animals, ganetespib can persist in tumor cells for over a week, while it is cleared from blood and normal tissues in a matter of
hours. Similar results demonstrating this characteristic have been published by others using first-generation Hsp90 inhibitors such as 17-AAG and its derivatives, as well as other classes of Hsp90
inhibitors.
HDCs
are drug candidates consisting of an Hsp90 inhibitor (targeting moiety) joined to an anti-cancer agent (payload) via a cleavable chemical linker optimized for controlled release of
payload drug inside cancer cells. HDCs are small molecules that do not rely on cell surface antigens for targeting and internalization for cellular uptake. Upon cell entry, typically via small
molecule uptake (passive diffusion and possibly active transport), HDCs can bind intracellular Hsp90 that is present in significant amounts in a wide range of cancers.
Upon
systemic administration HDCs have the potential to achieve significantly higher concentrations of active anticancer drugs (payloads) in tumors than the concentrations achieved when
such anticancer drugs are given in their original, unconjugated form. It is important to note that such high concentrations are sustained over prolonged periods of time, thus significantly increasing
the exposure of tumors to the anticancer drug relative to the exposure that can be achieved when such anticancer drugs are given in their original, unconjugated form.
Our
lead drug candidate from our HDC program is STA-12-8666, a conjugate of an Hsp90 inhibitor bound to SN-38, the highly potent active metabolite of the widely used chemotherapy
irinotecan. We have decided not to pursue an IND submission for STA-12-8666 in the immediate future. However, we are currently conducting preclinical studies for STA-12-8666 to support an IND
submission, if we determine to pursue such a submission at some point in the future.
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Other Programs
Elesclomol (Mitochondria-Targeting Agent)
In January 2016, we entered into an asset purchase agreement with a third party to further develop our drug candidate, elesclomol. We
will no longer be performing research activities on this drug candidate and, as part of the arrangement, we will receive a minority interest and Board representation in the third party, payments based
on achievement of certain development milestones and product royalties upon commercialization.
CRACM Ion Channel Inhibitors
In May 2014, we entered into a license arrangement for our CRACM program, including two lead candidates and the associated intellectual
property portfolio, with PRCL Research Inc. (PRCL), a company funded by TVM Life Science Venture VII and the Fonds de Solidarité des Travailleurs du Québec, based
in Montreal, Canada. PRCL's plans were to develop one of the two lead candidates licensed from us to proof-of-concept. We have recently been informed that PRCL has selected one of these
candidates to move forward into IND enabling studies.
We
hold a minority interest in PRCL and a seat on PRCL's board of directors. We are not required to provide any research funding or capital contributions to PRCL, and we
are not required to perform any research activities related to these candidates. We are reimbursed by PRCL for intellectual property management costs in connection with the contributed intellectual
property. If and when proof-of-concept is reached with either drug candidate, Eli Lilly and Company, which is an investor in TVM, will help manage the development program through one of its divisions
and will have an option to acquire PRCL or its assets at the then fair value.
Manufacturing and Supply
For a description of Synta's historical manufacturing and supply capabilities, please refer to the section entitled "Manufacturing and
Supply" included in the description of Synta's business in Part I, Item 1 of the Synta 10-K, which section is incorporated by reference herein.
Competition
For a description of Synta's competition, please refer to the section entitled "Competition" included in the description of Synta's
business in Part I, Item 1 of the Synta 10-K, which section is incorporated by reference herein.
Patents and Proprietary Rights
For a description of Synta's patents and propriety rights, please refer to the section entitled "Patents and Proprietary Rights"
included in the description of Synta's business in Part I, Item 1 of the Synta 10-K, which section is incorporated by reference herein.
Government Regulation
For a description of certain healthcare regulations encountered by Synta, please refer to the section entitled "Government Regulation"
included in the description of Synta's business in Part I, Item 1 of the Synta 10-K, which section is incorporated by reference herein.
Employees
As of June 1, 2016, Synta had nine full-time employees, principally in general and administrative functions. Synta's employees
are not represented by any collective bargaining agreement.
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Properties
For a description of Synta's properties, please refer to the section entitled "Properties" in Part I, Item 2 of the Synta
10-K, which section is incorporated by reference herein. Additionally, in April 2016, we entered into a Lease Termination Agreement (the "Termination") with Duffy Hartwell, LLC (the "Landlord")
which terminated the lease, dated as of November 4, 1996, by and between us and the Landlord, pursuant to which we leased 34,250 square feet of the building located at 45 Hartwell Avenue,
Lexington, MA 02421 (as amended, the "Lease"). The Lease was initially scheduled to expire on November 30, 2016. Pursuant to the Termination, the Lease was terminated early, effective as of the
date we vacated the premises and the Landlord received the final termination payment of approximately $213,000, both of which were required to occur prior to May 1, 2016 (the "Termination
Date"). Following the Termination Date, we have no further rent obligations to the Landlord pursuant to the Lease.
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MADRIGAL BUSINESS
Overview
Madrigal is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutic
candidates for the treatment of cardiovascular, metabolic and liver diseases. Madrigal's lead product candidate, MGL-3196, is a proprietary, liver-directed, selective thyroid hormone
receptor-ß, or THR-ß, agonist that can potentially be used to treat a number of disease states with high unmet medical need. THR-ß is known to regulate cholesterol
and triglyceride metabolism, which Madrigal believes suggests potential therapeutic benefits for patients suffering from hypercholesterolemia, genetic dyslipidemias and diseases resulting from
accumulation of fat in liver tissue, such as non-alcoholic steatohepatitis, or NASH. Based on scientific publications in human and animal studies, Madrigal believes that human NASH livers have a
deficiency in THR-ß activity that leads to features of NASH including fatty liver, inflammation and fibrosis, and that treatment with MGL-3196 may potentially replace this hormone
deficiency and be an effective NASH treatment.
Madrigal
believes that MGL-3196 is a first-in-class, highly selective, liver-directed THR-ß agonist. Madrigal is developing MGL-3196 for NASH and is planning to conduct a
Phase 2 clinical trial in this indication. Madrigal is also developing MGL-3196 for dyslipidemia, particularly genetic dyslipidemias such as familial hypercholesterolemia, or FH, including both
homozygous and heterozygous forms of the disease. Madrigal is planning to conduct two Phase 2 clinical trials in FH, one in heterozygous FH, or HeFH, patients and one a proof-of-concept
clinical trial in homozygous FH, or HoFH, patients. MGL-3196 is a once-daily oral pill that has been studied in three completed Phase 1 trials in a total of 115 subjects. MGL-3196 appeared to
be safe and well-tolerated in these trials, which included a single ascending dose trial, a multiple ascending dose trial, and a drug interaction trial with a statin.
In
the multiple ascending dose Phase 1 clinical trial in healthy volunteers with mildly elevated low-density lipoprotein cholesterol, or LDL-C, the administration of MGL-3196 in
once daily doses of up to 200 mg per day for 14 days demonstrated statistically significant reductions of LDL-C, apolipoprotein B, or apoB, and non-high density lipoprotein cholesterol, or
HDL-C, of up to 30%, and a reduction of triglycerides, or TG, of up to 60%. Increased levels of LDL-C, commonly known as "bad cholesterol", apoB and non-HDL-C are each strongly associated with
increased risk of heart disease. The lipid parameter reductions observed with MGL-3196 treatment occurred rapidly in the trial, becoming apparent within the first few days of dosing.
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The
following chart summarizes the status of Madrigal's product candidate development programs for MGL-3196 and MGL-3745, a preclinical compound which has similar thyroid receptor
selectivity to MGL-3196 and is thus a potential backup compound for MGL-3196:
Lead Product CandidateMGL-3196
Active thyroid hormone, known as T3, interacts with two nuclear receptors, THR-
a
, which is the
predominant receptor expressed in most human tissues, including heart and bone, and THR-
b
, which has more restricted tissue expression, and is the predominant
receptor responsible for metabolic actions in the liver, including both cholesterol- and TG lowering. Selective activation of the THR-ß receptor in liver tissue is believed to favorably
affect cholesterol and lipoprotein levels via multiple mechanisms, which may be complementary to those of other lipid-lowering therapies such as statin drugs. Madrigal believes that these
characteristics of THR-
b
activation by MGL-3196 will in turn lead to clinically meaningful reductions in LDL-C, plasma and liver TGs.
Madrigal
believes that MGL-3196 is the first selective small molecule THR-
b
agonist compound. MGL-3196, along with other
THR-
b
-selective small molecules, such as MGL-3745, a potential backup compound to MGL-3196, was discovered at Hoffmann-La Roche, or Roche, in Nutley, New Jersey,
by utilizing a novel functional assay that, unlike a simple receptor binding assay, assessed the functional activity of compounds which interacted with thyroid hormone receptors. In a published study
by Madrigal and Roche in the Journal of Medicinal Chemistry using this functional assay, MGL-3196 was shown to be highly selective for the THR-ß receptor, with almost no effect on
THR-
a
, unlike other compounds purported in published studies to be
b
-selective based on binding affinity, but which were
shown to equally activate THR-
a
and THR-
b
in the novel functional assay.
Madrigal
believes that the ß-selectivity and liver-targeting properties of MGL-3196 are critically important for its beneficial metabolic actions in the liver, and enable
avoidance of safety issues associated with THR-
a
activation by thyroid hormone and/or less selective THR agonists in tissues such as heart and bone. In a variety
of preclinical animal model studies, MGL-3196 showed enhanced safety relative to T3 or other thyroid agonists. In animal models, MGL-3196 demonstrated cholesterol lowering, liver triglyceride
lowering, and reduction of markers of NASH-related liver inflammation and fibrosis at drug levels similar to those that lowered LDL-C in human clinical trials, providing data to support the
advancement of MGL-3196 into NASH and FH clinical trials. In chronic animal toxicology studies in dogs and rats, no effects on bone or cartilage histology were seen at any MGL-3196 dose in either
species.
Madrigal
believes that MGL-3196 may be the first product candidate in development for NASH or FH that selectively targets the THR-ß pathway and has shown a lack of liver
enzyme elevations in
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Phase 1
clinical studies as well as an absence of bone and cartilage histologic findings in chronic animal toxicology studies.
MGL-3196 Clinical and Non-Clinical Development Program
To date, Madrigal has completed a series of Phase 1 clinical studies, Phase 2-enabling preclinical GLP toxicology
studies, and drug manufacturing studies to support further clinical development, including API manufacturing and drug product development studies, drug metabolism studies, acute, subchronic and
chronic animal toxicology studies, and other safety pharmacology and toxicology studies.
Madrigal
has completed Phase 1 studies with MGL-3196 in a total of 115 subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of MGL-3196.
Madrigal's Phase 1 studies included randomized, placebo-controlled, double-blind, single and 14-day multiple-dose escalation studies, as well as a drug-interaction study in healthy volunteers.
In Phase 1 studies, MGL-3196 appeared safe and was well-tolerated at all doses tested. The results of these studies suggest that MGL-3196 has pharmacokinetic properties suitable for once-daily
oral dosing.
In
the multiple ascending dose study, lipid parameters were assessed as initial markers of MGL-3196 pharmacodynamic activity (Atherosclerosis 230:373-380, 2013). As illustrated in the
figure below, daily doses of MGL-3196 ranging from 50 to 200 mg showed highly statistically significant reductions relative to placebo of up to 30% for LDL-C (range, p=.05- <0.0001), 28%
for non-HDL-C (range, p =0.027- p<0.0001) and 24% for apoB (range, p =0.008-0.0004), and statistical trends of up to 60% reduction in TG (range, p =0.13-0.016). The near maximal lipid
effects were observed at a MGL-3196 dose of 80 mg once-daily. MGL-3196 was well-tolerated at all doses, with no dose-related adverse events or liver enzyme, electrocardiography or vital-sign changes.
At the highest dose of MGL-3196 (200 mg), there was a reversible reduction of 20% in the level of a precursor hormone to T3, free T4, which was significantly different from placebo (p <
0.0001) that may be explained by increased liver metabolism of free T4. There was no change in thyrotropin, a pituitary hormone that regulates the level and production of thyroid hormone by the
thyroid gland or T3, or other evidence of central thyroid axis dysfunction at any dose of MGL-3196.
Change in Lipids After 14 Days
Change from Baseline (CFB) by mean % CFB calculated for each individual subject 24th after 14th dose; baseline value obtained just prior
to first dose; ApoB, apolipoprotein B; Chal, total cholesterol; LDL-C, LDL cholesterol directly measured; Non-HDL-C, non-HDL cholesterol; TG, triglycerides (median %CFB)
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While Madrigal is encouraged by these results, they are based on a small number of patients in early-stage clinical trials and are not necessarily
predictive of results in later-stage clinical trials with larger and more diverse patient populations. In addition, the FDA typically requires sponsors of lipid-lowering product candidates to conduct
drug-drug interaction studies with statins because statins may have increased safety risks when administered together with other drug therapies that affect their pharmacokinetic profile. Accordingly,
shortly after Madrigal submitted an IND for MGL-3196 in 2011, the FDA placed a partial clinical hold on MGL-3196 that requires Madrigal to provide the FDA with
certain information on dosing of MGL-3196 concomitantly with statins before the partial clinical hold can be removed. Madrigal has since received guidance from the FDA that the results from drug
interaction studies between MGL-3196 and several statins conducted in healthy volunteers and other supportive information could enable the removal of the partial clinical hold on dosing MGL-3196 in
patients taking statins. Madrigal has completed one clinical drug interaction study of MGL-3196 and two statins in 25 normal healthy volunteers, which showed MGL-3196 to have a favorable safety
profile and to be well-tolerated. Madrigal is currently conducting a second drug-interaction study of MGL-3196 with a third statin. After completion of the second study, Madrigal intends to submit the
data to the FDA from the drug interaction studies of MGL-3196 with statins and other supportive data as a complete response to the partial clinical hold that the FDA placed on MGL-3196. If, following
the submission, the FDA removes the partial clinical hold, Madrigal will dose MGL-3196 in patients who are taking statins in the planned Phase 2 clinical trials.
Target Indications
Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis
NASH is a serious inflammatory form of non-alcoholic fatty liver disease, or NAFLD. NAFLD has become the most common liver disease in
the United States and other developed countries and is characterized by an accumulation of fat in the liver with no other apparent causes. The rising worldwide prevalence of obesity-related disorders
has contributed to a rapid increase in the global prevalence of NASH and NAFLD. In the United States, NAFLD is estimated to affect approximately 27% to 34% of the population, or an estimated
86 million to 108 million people, and approximately 10% to 20% of those will progress from NAFLD to NASH. Current estimates place NASH prevalence at approximately 9 million to
15 million people in the United States, or 3% to 5% of the population, with similar prevalence in Europe and Asia. The prevalence of NASH is also increasing in developing regions due to the
adoption of a more sedentary lifestyle and a diet consisting of processed foods with high fat and fructose content.
In
addition to the accumulation of fat in the liver, NASH is characterized by inflammation and cellular damage with or without fibrosis, the first stage of liver scarring, which may
ultimately progress to cirrhosis. NASH is a severe condition that can lead to fibrosis and eventually progress to cirrhosis, portal hypertension, esophageal varices, ascites, liver cancer and liver
failure. NASH is strongly associated with cardiovascular disease, or CVD, and the most common cause of death in NASH patients is CVD. Progression to cirrhosis and other late-stage complications can
occur within 5 to 10 years after an initial NASH diagnosis. NASH patients with type-2 diabetes have a heightened risk of NASH disease progression. Once the disease advances beyond NASH to such
life-threatening conditions as liver cancer and failure, then liver transplantation is the only treatment alternative.
The
Centers for Disease Control and Prevention projects the prevalence of obesity to increase from 34% of the United States population to 42% of the United States population by 2030.
Driven by this epidemic of obesity, NASH is projected to become the leading cause of liver transplants by 2020. Given the extremely limited availability of organ donors and high transplant costs, NASH
patients who require transplantation will place a significant economic burden on the healthcare system. As such,
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there
is a significant unmet medical need for well-tolerated oral treatments for NASH. Because there are currently no therapeutic products approved for the treatment of NASH, the market size is
difficult to estimate. However, based on Madrigal's analysis of multiple market assessments, it estimates that the addressable NASH population is several million patients worldwide, and that NASH
could become a multi-billion dollar market able to support multiple approved drug products.
Madrigal is developing MGL-3196 for NASH. Based on the scientific literature in human and animal studies, Madrigal believes that NASH
livers in humans frequently have a deficiency in THR-ß activity that leads to features of NASH, including fatty liver, inflammation and fibrosis, and that treatment with MGL-3196 will
replace this hormone deficiency and be an effective NASH treatment. Madrigal believes that MGL-3196 is an excellent candidate for the chronic treatment of NASH because of its safety and tolerability
profile observed to date in healthy subjects, its effects in reducing cardiovascular risk factors such as LDL-C and TGs in early-stage clinical trials, and its multiple beneficial effects in animal
models of NASH. CVD is the most common cause of death in patients with NASH. Madrigal has completed multiple studies in animal models of metabolic diseases, dyslipidemia and NASH in which MGL-3196
demonstrated a statistically significant reduction in liver TGs, insulin resistance, liver enzymes (which may be elevated in NASH), and markers
of inflammation and fibrosis (Figures). The figures below show the beneficial effects of MGL-3196 to reduce these parameters in NASH animal models. Madrigal believes that MGL-3196 will treat the
underlying lipotoxicity that drives the inflammation and liver cell damage observed in NASH patients, and after the underlying lipotoxicity is treated, NASH-related liver fibrosis will resolve as the
liver regenerates.
Upper panels: 24d study in 17 wk old DIO mice (po, qd) on high fat diet (HFD) 13 wks;
lower panels: 24d study in 40 wk old DIO mice on HFD 35 wks
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MGL-3196 Preclinical NASH Animal Model Gene Expression Study
25 week study in DIO, lean control mice and HFD mice treated with 0.1 to 3 mg/kg
MGL-3196 or Rosiglitazone (3mg/kg)
"HFD", lane 1 mean HFD gene expression normalized to mean Lean; Lanes (2-7) mean gene expression normalized to mean of DIO; "Rosi"
(rosiglitazone, 3 mg/kg, 24 weeks) TIMP1 tissue inhibitor metalloproteinase; CTGF connective tissue growth factor; SMA smooth muscle actin; SAA serum amyloid A; CRP C-reactive protein
Red, higher expression; blue decreased expression
Madrigal plans to conduct a Phase 2 proof of concept clinical trial in approximately 100 patients with liver biopsy documented
NASH. The proposed study is a randomized, 1:1:1, double-blind, placebo-controlled, three-arm study of two doses of once-daily MGL-3196 versus placebo in patients with NASH, including those with type-2
diabetes, for six or nine months (the duration currently under discussion) of treatment. The study will be conducted in the United States. The primary endpoint will be to evaluate the efficacy of
MGL-3196 as measured by the reduction of liver fat at 12 weeks, and the secondary endpoint will be to evaluate the efficacy of MGL-3196 as measured by a reduction of NASH, which will be
assessed by liver biopsy, at 24 weeks. Other secondary and exploratory endpoints will include safety and tolerability, and effects on serum biomarkers at 12 and 24 weeks, lipid
parameters, and biomarker measures of insulin sensitivity. Madrigal expects to reach
its top-line analysis of the primary endpoint in mid-2017 and its top-line analysis of the secondary endpoint (NASH assessment on liver biopsy) by the end of 2017.
In
September 2013, the American Association for the Study of Liver Disease and the FDA conducted a joint workshop focused on trial designs and endpoints in drug and diagnostic
development for liver disease secondary to NAFLD, including NASH. In December 2014, the journal Hepatology accepted for publication a manuscript summarizing the workshop output, including potentially
acceptable surrogate endpoints for clinical studies supporting the approval of agents for NASH and liver fibrosis. Madrigal believes that its Phase 2 NASH study design incorporates surrogate
endpoints that may form the basis for demonstrating efficacy required for approval based on the published workshop summary and feedback from FDA in response to Madrigal's NASH pre-IND submission in
2014.
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Familial Hypercholesterolemia
FH is a genetic disorder characterized by aggressive and early onset of CVD. In people with FH, genetic mutations make the liver
incapable of metabolizing or removing excess LDL-C, causing very high LDL-C levels in the blood. There are two forms of FH: HoFH, a less common condition where mutation is inherited from both parents,
and HeFH, a more common
condition where mutation is inherited from just one parent. The vast majority of the cholesterol circulating in a person's body is produced by the liver. Cholesterol is a necessary component in the
structure and function of human cells. Individuals with FH are unable to recycle this natural supply of cholesterol that their bodies are constantly producing. Therefore, the cholesterol levels of an
individual with FH are exceedingly high. Over time, the elevated blood cholesterol can lead to blockages in the arteries of the heart and/or brain. The longer a person experiences high LDL-C, the more
likely he or she will be to experience a cardiovascular event (i.e., heart attack or stroke).
HoFH
has an estimated worldwide prevalence of 1 in 160,000 to 1 in 1,000,000 and is a life-threatening condition characterized by markedly elevated levels of LDL-C. This is predominantly
due to inactivating mutations in the LDL receptor, with onset of atherosclerotic CVD in childhood to early adulthood. HeFH, more common than HoFH, has an estimated worldwide prevalence of 1 in
200 to 1 in 500 and is characterized by early onset CVD in middle age, typically caused by an inactivating mutation in one of the two LDL receptor genes. While HeFH patients have a range of
disease severity, Madrigal believes approximately 10% of the HeFH population can be characterized as having severe FH, with higher baseline LDL-C levels (>309 mg/dL; 8 mmol/L) than those of a majority
of the HeFH population. Despite multiple therapeutics currently available for the treatment of HoFH, including statins, ezetimibe, and newer agents such as lomitapide, mipomersen, and anti-PCSK9
antibodies, Madrigal believes that the treatment target goal to reduce LDL-C to recommended levels is rarely achieved. In HeFH, with the recent addition of anti-PCSK9 antibodies to the treatment
regimen, Madrigal believes that LDL-C target treatment goals (<100 mg/dL; < 70 mg/dL in patients with CVD or diabetes) may be achieved in > 50% of the patients; however, many
HeFH patients, particularly those with severe FH or who cannot tolerate treatment with high-dose statins, are not at goal and are in need of additional lipid-lowering therapies beyond current
therapeutic approaches. In addition, elevation of lipoprotein(a), or Lp(a), a severely atherogenic lipoprotein particle, which is frequently elevated in FH patients, is not effectively lowered by
current therapeutic approaches. In 2014, an estimated $16.6 billion was spent on drug therapy in the United States, five major European Union markets, and Japan to treat dyslipidemias,
according to Datamonitor.
Madrigal is developing MGL-3196 for FH and potentially other genetic dyslipidemias. Madrigal believes that experimental results from
various sources, including itself, academic groups and other pharmaceutical companies, support targeting the THR-ß pathway as a potential novel approach to lipid-lowering in FH. Madrigal
believes that MGL-3196 has a unique and complementary lipid-lowering profile that will bring an added benefit to the standard of care treatment of FH patients, particularly those with severe HeFH
(~10% of FH patients with high baseline LDL-C, typically >309 mg/dL) and those with HoFH who do not achieve LDL-C target levels with current therapies. Specifically, in preclinical animal studies
MGL-3196 lowered LDL-C in a variety of species as a monotherapy and also when dosed in combination with statins. MGL-3196 also showed the potential to lower Lp(a), a severely atherogenic particle that
is frequently elevated in patients with FH. A previous THR agonist, eprotirome, demonstrated clinical proof of concept for the THR target in Phase 2 and Phase 3 FH clinical trials by
significantly lowering LDL-C and Lp(a) in patients with HeFH who were on standard treatments such as statins and ezetimibe. The development of eprotirome
ceased during the Phase 3 FH trial due to liver toxicity observed in the trial as well as eprotirome-induced cartilage damage seen
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chronic toxicology studies in dogs. Because of its high level of THR-ß selectivity, its liver-targeting properties, and its absence of findings in chronic animal toxicology studies,
Madrigal believes that MGL-3196 will avoid the toxicity issues of previous THR agonist compounds and may be a beneficial treatment for FH patients.
Madrigal plans to conduct a Phase 2 clinical trial in approximately 100 patients with HeFH. The proposed study is a randomized
1:1:1, double-blind, placebo-controlled, three-arm study of two daily doses of MGL-3196 or placebo in patients with HeFH. The study will be conducted primarily in the United States with additional
sites in Europe. In this 12 week clinical trial, the primary endpoint will be to evaluate the efficacy of MGL-3196 as measured by the percent reduction in LDL-C as compared with placebo.
Secondary endpoints will include safety and tolerability, and evaluate the efficacy of MGL-3196 to reduce a variety of lipid parameters, including non-HDL-C, apoB, TGs, Lp(a), apoA/B, and lipoprotein
particles. Based on interim efficacy and safety data obtained from this HeFH study, Madrigal plans to conduct a proof of concept open-label Phase 2 study of 6-8 patients with HoFH at sites in
the United States and Europe. Madrigal expects that topline results of the HeFH and HoFH clinical trials will be available in the second half of 2017.
Collaborations
VIA Pharmaceuticals, Inc., or VIA, entered into a research, development and commercialization agreement, or the Roche Agreement,
with Hoffmann-La Roche Pharmaceutical Company Limited, or Roche, on December 18, 2008. Madrigal subsequently assumed all of VIA's rights in, to and under, and all of VIA's obligations under,
the Roche Agreement pursuant to an asset purchase agreement dated September 14, 2011, as described in more detail under the heading "General Corporate Information" below. Pursuant to the terms
of the Roche Agreement, Madrigal, as successor-in-interest to VIA, assumed control of all development and commercialization of MGL-3196 and will own exclusive worldwide rights for all potential
indications. Roche assigned all patent rights
relating to MGL-3196 to Madrigal and granted Madrigal an exclusive license to use certain know-how relating to MGL-3196 in exchange for consideration consisting of an upfront payment, milestone
payments, the remainder of which total $10.8 million and are tied to future commencement of Phase 2 and Phase 3 clinical trials and regulatory approval in the United States and
Europe of a product developed from MGL-3196, and single-digit royalty payments based on net sales of products developed from MGL-3196, subject to certain reductions. In 2011, Madrigal commenced
Phase 1 clinical trials and subsequently paid Roche a related milestone payment. To date, Madrigal has not achieved any additional product development or regulatory milestones under the Roche
Agreement.
Pursuant
to the Roche Agreement, Madrigal must use commercially reasonable efforts to conduct clinical and commercial development programs for products containing MGL-3196. If Madrigal
determines that it is not reasonable to continue clinical trials or other development of MGL-3196, it may elect to cease further development and Roche may terminate the license. If Madrigal determines
not to pursue the development or commercialization of MGL-3196 in certain jurisdictions, including the United States, Roche may terminate the license for such territories. The Roche Agreement will
expire, unless earlier terminated pursuant to other provisions of the agreement, on the last to occur of (i) the expiration of the last valid claim of a licensed patent covering the
manufacture, use or sale of products containing MGL-3196, or (ii) ten years after the first sale of a product containing MGL-3196.
Competition
The development and commercialization of new drugs is highly competitive. Madrigal will face competition with respect to all product
candidates Madrigal may develop or commercialize in the future from pharmaceutical and biotechnology companies worldwide. The key factors affecting the
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of any approved product will be its efficacy, safety profile, drug interactions, method of administration, pricing, reimbursement and level of promotional activity relative to those of
competing drugs.
Madrigal's
potential competitors may have substantially greater financial, technical, and personnel resources than Madrigal. In addition, many of these competitors have significantly
greater commercial infrastructures. Madrigal's ability to compete successfully will depend largely on its ability to leverage its collective experience in drug discovery, development and
commercialization to:
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discover and develop medicines that are differentiated from other products in the market,
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obtain patent and/or proprietary protection for Madrigal's products and technologies;
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obtain required regulatory approvals;
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obtain a commercial partner;
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commercialize its drugs, if approved; and
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attract and retain high-quality research, development and commercial personnel.
There
are currently no therapeutic products approved for the treatment of NASH. There are several commercially available products that are currently used off-label for NASH, such as
vitamin E, an antioxidant, insulin sensitizers, such as pioglitazone, anti-hyperlipidemic agents, such as gemfibrozil, pentoxifylline, ursodiol and others. In addition, there are numerous drugs in
development for the treatment of NASH. Madrigal is aware of several companies that have product candidates in clinical development for the treatment of NASH, including Intercept
Pharmaceuticals, Inc., Gilead Sciences, Inc., Galectin Therapeutics, Inc., Tobira Pharmaceuticals, Galmed Medical Research Ltd., Genfit Corp., Novartis AG, Novo Nordisk
A/S, Takeda, Immuron Ltd., Shire plc, Boehringer Ingelheim GmbH, and Conatus Pharmaceuticals Inc., and there are other companies with candidates in earlier stages of
development. Given MGL-3196's actions on the underlying biological pathways across the spectrum of early to late stages of NASH, its CV beneficial effects, and its complementary mechanism to other
therapies, Madrigal believes that MGL-3196 has the potential to be used alone or in combination with some of these potential NASH products.
There
are several marketed products, both generic and proprietary, available for the treatment of HoFH and HeFH. Madrigal believes that MGL-3196 has the potential to be used in
combination with several of these products. Available marketed products include: various statins, Merck's ezetimibe, Aegerion's lomitapide, Ionis' mipomersen, Amgen's evolocumab and Sanofi/Regeneron's
alirocumab. In addition, there are multiple drugs in development for the treatment of FH, including Gemphire's gemcabene, Merck's anacetrapib, Esperion's ETC-1002, and drugs at an earlier stage of
development. Given MGL-3196's pleotropic lipid-lowering actions, its complementary mechanism to statins and other lipid-lowering drugs, and its potential for lowering Lp(a), Madrigal believes that
MGL-3196 has the potential to be used in combination with the standard of care to treat patients with HoFH and HeFH.
Sales and Marketing
Because Madrigal is focused on discovery and development of its product candidates, it currently has no sales, marketing or
distribution capabilities in order to commercialize any approved product candidates. If Madrigal's product candidates are approved, Madrigal intends either to establish a sales and marketing
organization with technical expertise and supporting distribution capabilities to commercialize its products, or to outsource this function to a third party.
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Manufacturing
Madrigal does not own or operate, and currently has no plans to establish, any manufacturing facilities. Madrigal currently relies, and
expects to rely, on third-party contract manufacturers, or CMOs, for the manufacture of any product candidates that it may develop for larger-scale preclinical and clinical testing, as well as for
commercial quantities of any drug candidates that are approved.
Research and Development
Research and development expenses primarily consist of costs associated with Madrigal's research activities, including the preclinical
and clinical development of Madrigal's product candidates. Madrigal's research and development expenses were $2.4 million for the year ended December 31, 2015 compared to
$0.8 million for the same period in 2014. The large increase in reseach and development expenses was primarily due to continuation of the preclinical studies initiated by Madrigal in 2014,
further API manufacturing studies and the completion of a Phase 1 clinical study in 2015. Madrigal expects research and development expenses to increase over time as it advances its clinical
and preclinical development programs for MGL-3196.
Employees
As of June 1, 2016, Madrigal had no full-time employees and four full-time equivalent consultants and multiple part-time
consultants. Immediately following the completion of the merger, the executive management team of Madrigal is expected to be composed of Paul A. Friedman, M.D., serving as the Chief Executive Officer
and Chairman of the Board of the combined company, Rebecca Taub, M.D., serving as Chief Medical Officer, Executive Vice President, Research & Development and a director of the combined company,
and Marc R. Schneebaum serving as Chief Financial Officer of the combined company.
Intellectual Property
Madrigal will be able to protect its technology and products from unauthorized use by third parties only to the extent it is covered by
valid and enforceable patents or such knowledge is effectively maintained as trade secrets. Patents and other proprietary rights are thus an essential element of Madrigal's business. Madrigal also
relies on trade secrets, know-how, continuing technological innovation and licensing opportunities to develop and maintain its competitive position.
Madrigal's
success will depend in part on its ability to obtain and maintain patent and other proprietary protection for its current and future product candidates, technology and
know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing its proprietary rights. Madrigal seeks to protect its proprietary position by, among
other methods, filing United States and foreign patent applications related to its proprietary technology, inventions and improvements that are important to the development of its business.
Madrigal
owns or has exclusive rights to four United States and 70 foreign issued patents and allowed patent applications, and one United States and 26 foreign pending patent
applications, relating to composition-of-matter of MGL-3196 and its use in the treatment of key disease indications. Madrigal's current patent portfolio broadly covers the United States and other
jurisdictions worldwide.
Issued
United States patents which cover MGL-3196 will expire between 2026 and 2033, excluding any patent term extensions that might be available following the grant of marketing
authorizations. Issued patents outside of the United States directed to MGL-3196 will expire between 2026 and 2033. Madrigal has pending patent applications for MGL-3196 that, if issued, would expire
in the United States and in countries outside of the United States between 2026 and 2033, excluding any patent term
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that might be available following the grant of the patent and any patent term extensions that might be available following the grant of marketing authorizations.
In
addition, pursuant to the Roche Agreement, Roche granted Madrigal an exclusive license to certain patents and know-how relating to MGL-3196. The Roche Agreement imposes various
diligence, milestone payment, royalty payment, insurance, indemnification, and other obligations on Madrigal.
Madrigal's
trademarks are protected under the common law and/or by registration in the United States and other countries. Madrigal seeks to protect its proprietary processes, in part, by
confidentiality agreements and invention assignment agreements with its personnel, including consultants and commercial partners. These agreements are designed to protect Madrigal's proprietary
information.
Orphan Drug Designation
Some of MGL-3196's target disease indications are rare diseases or may be designated rare diseases, including HoFH and severe HeFH, and
Madrigal plans to pursue orphan drug designation where possible. If granted, each such designation might provide for regulatory exclusivity for seven years in the United States and ten years in the
European Union from the date of product approval for individual indications.
Government Regulation
Government Regulation and Product Approval
Government authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among
other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and
import of products such as those Madrigal is developing. A new drug must be approved by the FDA through the new drug application, or NDA, process and a new biologic must be approved by the FDA through
the biologics license application, or BLA, process before it may be legally marketed in the United States The animal and other non-clinical data and the results of human clinical trials performed
under an Investigational New Drug application, or IND, and under similar foreign applications will become part of the NDA or BLA.
United States Drug Development Process
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and in the case of biologics,
also under the Public Health Service Act, or PHSA, and implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and
foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the product
development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA's refusal to approve pending
applications, withdrawal of an approval, a clinical hold, warning letters, requesting product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines,
refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required
by the FDA before a drug or biologic may be marketed in the United States generally involves the following:
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completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices or other
applicable regulations;
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submission to the FDA of an IND which must become effective before human clinical trials may begin;
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performance of adequate and well-controlled human clinical trials according to Good Clinical Practices to establish the safety and
efficacy of the proposed drug for its intended use;
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submission to the FDA of an NDA or BLA;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess
compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity; and
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FDA review and approval of the NDA or BLA.
Once
a pharmaceutical candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity
and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND.
The sponsor will also include a protocol detailing, among other things, the objectives of the first phase of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness
criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective
30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold or a partial clinical hold. In such a case, the IND sponsor and the
FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during studies due to safety concerns or
non-compliance.
All
clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with good clinical practice regulations. They must be conducted under
protocols detailing the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted
to the FDA as part of the IND, and progress reports detailing the results of the clinical trials must be submitted at least annually. In addition, timely safety reports must be submitted to the FDA
and the investigators for serious and unexpected adverse events. An institutional review board, or IRB, at each institution participating in the clinical trial must review and approve each protocol
before a clinical trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal
representative, monitor the study until completed and otherwise comply with IRB regulations.
Human
clinical trials are typically conducted in three sequential phases that may overlap or be combined:
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Phase I:
The product candidate is initially
introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening
diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
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Phase II:
This phase involves studies in a limited
patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and
optimal dosage.
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Phase III:
Clinical trials are undertaken to
further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall
risk-benefit ratio of the product candidate and provide, if appropriate, an adequate basis for product labeling.
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The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed
to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's
requirements or if the drug has been associated with unexpected serious harm to patients. Phase I, Phase II, and Phase III testing may not be completed successfully within any
specified period, if at all.
During
the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND, at the end of
Phase II, and before an NDA or BLA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered
to date, for the FDA to provide advice, and for the sponsor and FDA to reach agreement on the next phase of development. Sponsors typically use the end of Phase II meeting to discuss their
Phase II clinical results and present their plans for the pivotal Phase III clinical trial that they believe will support approval of the new drug.
Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the
drug and finalize
a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the
product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate packaging must be
selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
United States Review and Approval Processes
The results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process,
analytical tests conducted on the chemistry of the drug, proposed labeling, and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market the product.
The submission of an NDA or BLA is subject to the payment of user fees; a waiver of such fees may be obtained under certain limited circumstances. The FDA reviews all NDAs and BLAs submitted to ensure
that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept a NDA or BLA for filing. In this event, the
NDA or BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review. FDA may refer the NDA or BLA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and
under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The approval process is lengthy and often difficult, and the
FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. Even if such data and information is
submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data
differently than Madrigal interprets the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that must be met in
order to secure final approval of the NDA or BLA, or an approval letter following satisfactory completion of all aspects of the review process. The FDA reviews an NDA to determine, among other things,
whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product's identity, strength, quality and purity. The FDA
reviews a BLA to determine, among other things whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held
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standards designed to assure the product's continued safety, purity and potency. Before approving an NDA or BLA, the FDA will inspect the facility or facilities where the product is
manufactured.
NDAs
or BLAs receive either standard or priority review. A drug representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review.
Priority review for an NDA for a new molecular entity and original BLAs will be six months from the date that the NDA or BLA is filed. In addition, products studied for their safety and effectiveness
in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate
and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a
clinical endpoint that can be measured earlier than irreversible morbidity or mortality, or IMM, that is reasonably likely to predict an effect on IMM or other clinical benefit. As a condition of
approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. Priority review and accelerated approval do
not change the standards for approval, but may expedite the approval process.
If
a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could
restrict the commercial value of the product. In addition, the FDA may require a sponsor to conduct Phase IV testing which involves clinical trials designed to further assess a drug's safety
and effectiveness after NDA or BLA approval, and may require testing and surveillance programs to monitor the safety of approved products which have been commercialized.
The
Food and Drug Administration Safety and Innovation Act, or FDASIA, which was enacted in 2012, made permanent the Pediatric Research Equity Act, or PREA, which requires a sponsor to
conduct pediatric studies for most drugs and biologics, for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration. Under PREA, original NDAs, BLAs
and supplements thereto, must contain a pediatric assessment unless the sponsor has received a deferral or waiver. The required assessment must assess the safety and effectiveness of the product for
the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The sponsor or FDA
may request a deferral of pediatric studies for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug or biologic is ready for
approval for use in adults before pediatric studies are complete or that additional safety or effectiveness data needs to be collected before the pediatric studies begin. After April 2013, the FDA
must send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.
Patent Term Restoration and Marketing Exclusivity
Depending upon the timing, duration and specifics of FDA approval of Madrigal's product candidates, some of Madrigal's United States
patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984,
referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA
regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product's approval date. The patent term restoration
period is generally one-half the time between the effective date of an IND, and the submission date of an NDA or BLA, plus the time between the submission date of an NDA or BLA and the approval of
that application, except that the period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved drug is eligible for the
extension, and the extension must be applied
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prior to expiration of the patent. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
Pediatric
exclusivity is another type of marketing exclusivity available in the United States. The FDASIA made permanent the Best Pharmaceuticals for Children Act, or BPCA, which
provides for an additional six months of marketing exclusivity if a sponsor conducts clinical trials in children in response to a written request from the FDA, or a Written Request. If the Written
Request does not include studies in neonates, the FDA is required to include its rationale for not requesting those studies. The FDA may request studies on approved or unapproved indications in
separate Written Requests. The issuance of a Written Request does not require the sponsor to undertake the described studies.
Biologics Price Competition and Innovation Act of 2009
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act which included the Biologics
Price Competition and Innovation Act of 2009, or BPCIA. The BPCIA amended the PHSA to create an abbreviated approval pathway for two types of "generic" biologicsbiosimilars and
interchangeable biologic products, and provides for a twelve-year exclusivity period for the first approved biological product, or reference product, against which a biosimilar or interchangeable
application is evaluated; however if pediatric studies are performed and accepted by the FDA, the twelve-year exclusivity period will be extended for an additional six months A biosimilar product is
defined as one that is highly similar to a reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between
the biological product and the reference product in terms of the safety, purity and potency of the product. An interchangeable product is a biosimilar product that may be substituted for the reference
product without the intervention of the healthcare provider who prescribed the reference product.
The
biosimilar applicant must demonstrate that the product is biosimilar based on data from (i) analytical studies showing that the biosimilar product is highly similar to the
reference product; (ii) animal studies (including toxicity); and (iii) one or more clinical studies to demonstrate safety, purity and potency in one or more appropriate conditions of use
for which the reference product is approved. In addition, the applicant must show that the biosimilar and reference products have the same mechanism of action for the conditions of use on the label,
route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity and potency.
An
application for a biosimilar product may not be submitted until four years after the date on which the reference product was first approved. The first approved interchangeable
biologic product will be granted an exclusivity period of up to one year after it is first commercially marketed, but the exclusivity period may be shortened under certain circumstances.
The
FDA has issued a number of final and draft guidances in order to implement the law. On April 28, 2015, the FDA issued the following three final guidances: "Scientific
Considerations in Demonstrating Biosimilarity to a Reference Product," "Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product," and
"Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry." The draft guidances include "Formal Meetings between
the FDA and Biosimilar Biological Product Sponsors or Applicants" issued March 29, 2013, "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product" issued
May 13, 2014, "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act" issued August 4, 2014, and "Biosimilars: Additional Questions and
Answers Regarding Implementation of the Price Competition and Innovation Act of 2009," issued May 12, 2015. The guidance documents
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provide
FDA's current thinking on approaches to demonstrating that a proposed biological product is biosimilar to a reference product. The FDA intends to issue additional guidance documents in the
future. Nevertheless, the absence of final guidance documents covering all biosimilars issues does not prevent a sponsor for seeking licensure of a biosimilar under the BPCIA, and the FDA recently
approved the first biosimilar application in the United States.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is
generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable
expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug. Orphan
drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed
publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. If a product that has orphan drug designation
subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any
other applications to market the same drug for the same indication, except in very limited circumstances, for seven years. Orphan drug exclusivity, however, also could block the approval of one of
Madrigal's product candidates for seven years if a competitor obtains approval of the same drug as defined by the FDA or if Madrigal's product candidate is determined to be contained within the
competitor's product for the same indication or disease.
The
FDA also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials to support the approval of drugs, biologics, medical
devices, and medical foods for rare diseases and conditions. A product does not have to be designated as an orphan drug to be eligible for the grant program. An application for an orphan grant should
propose one discrete clinical study to facilitate FDA approval of the product for a rare disease or condition. The study may address an unapproved new product or an unapproved new use for a product
already on the market.
Fast Track Designation and Accelerated Approval
FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or
life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the
sponsor of a new drug candidate may request that FDA designate the drug candidate for a specific indication as a fast track drug concurrent with, or after, the filing of the IND for the drug
candidate. FDA must ermine if the drug candidate qualifies for fast track designation within 60 days of receipt of the sponsor's request.
Under
the fast track program, FDA may designate a drug for fast-track status if it is intended to treat a serious or life-threatening illness and nonclinical or clinical data demonstrate
the potential to address an unmet medical need. Similarly, the agency may designate a drug for accelerated approval if it treats a serious condition and generally provides meaningful therapeutic
benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than
irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or
prevalence of the condition and the availability or lack of alternative treatments.
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In
clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels,
functions, or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug candidate approved on this basis is subject to rigorous post-marketing
compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies,
or confirm a clinical benefit during post-marketing studies, will allow FDA to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under
accelerated regulations are subject to prior review by FDA.
In
addition to other benefits such as the ability to use surrogate endpoints and engage in more frequent interactions with FDA, FDA may initiate review of sections of a fast track drug's
BLA before the application is complete. This rolling review is available if the applicant provides, and FDA approves, a schedule for the submission of the remaining information and the applicant pays
applicable user fees. However, FDA's time period goal for reviewing an application does not begin until the last section of the BLA is submitted. Additionally, the fast track designation may be
withdrawn by FDA if FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
In
FDASIA, Congress encouraged the FDA to utilize innovative and flexible approaches to the assessment of products under accelerated approval. The law required the FDA to issue related
draft guidance within a year after the law's enactment and also promulgate confirming regulatory changes. In May 2014, the FDA published a Guidance for Industry entitled, "Expedited Programs for
Serious Conditions-Drugs and Biologics" which provides guidance on FDA programs that are intended to facilitate and expedite development and review of new drugs as well as threshold criteria generally
applicable to concluding that a drug is a candidate for these expedited development and review programs. In addition to the Fast Track, accelerated approval and priority review programs discussed
above, the FDA also provided guidance on a new program for Breakthrough Therapy designation. A request for Breakthrough Therapy designation should be submitted concurrently with, or as an amendment to
an IND. FDA has already granted this designation to over 30 new drugs and has approved several.
Post-Approval Requirements
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory standards is not maintained or if problems
occur after the product reaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the
market. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and
approval. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies,
and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws and regulations. Madrigal relies, and expects to continue to rely, on
third parties for the production of clinical and commercial quantities of its product candidates. Future inspections by the FDA and other regulatory agencies may identify compliance issues at the
facilities of Madrigal's contract manufacturers that may disrupt production or distribution, or require substantial resources to correct.
Any
drug products manufactured or distributed by Madrigal pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping
requirements, reporting of adverse experiences with the drug, providing the FDA with updated safety and efficacy information, drug sampling and distribution requirements, complying with certain
electronic records and signature requirements, and complying with FDA promotion and advertising requirements. FDA strictly regulates labeling, advertising, promotion and other types of information on
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products
that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label.
From
time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing
of products regulated by the FDA. It is impossible to predict whether further legislative changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such
changes, if any, may be.
Foreign Regulation
In addition to regulations in the United States, Madrigal will be subject to a variety of foreign regulations governing clinical trials
and commercial sales and distribution of its products. Whether or not Madrigal obtains FDA approval for a product, Madrigal must obtain approval by the comparable regulatory authorities of foreign
countries or economic areas, such as the 28-member European Union, before Madrigal may commence clinical trials or market products in those countries or areas. The approval process and requirements
governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval.
Under
European Union regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized procedure. The centralized procedure, which
is compulsory for medicinal products produced by biotechnology or those medicinal products containing new active substances for specific indications such as the treatment of AIDS, cancer,
neurodegenerative disorders, diabetes, viral diseases and designated orphan medicines, and optional for other medicines which are highly innovative. Under the centralized procedure, a marketing
application is submitted to the EMA where it will be evaluated by the Committee for Medicinal Products for Human Use and a favorable opinion typically results in the grant by the European Commission
of a single marketing authorization that is valid for all European Union member states within 67 days of receipt of the opinion. The initial marketing authorization is valid for five years, but
once renewed is usually valid for an unlimited period. The decentralized procedure provides for approval by one or more "concerned" member states based on an assessment of an application performed by
one member state, known as the "reference" member state. Under the decentralized approval procedure, an applicant submits an application, or dossier, and related materials to the reference member
state and concerned member states. The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within
90 days of receiving the reference member state's assessment report, each concerned member state must decide whether to approve the assessment report and related materials. If a member state
does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whose decision is binding on all member states.
When
conducting clinical trials in the EU, Madrigal must adhere to the provisions of the EU Clinical Trials Directive and the laws and regulations of the EU Member States implementing
them. These provisions require, among other things, that the prior authorization of an Ethics Committee and the submission and approval of a clinical trial authorization application be obtained in
each Member State be obtained before commencing a clinical trial in that Member State.
As
in the United States, it may be possible in foreign countries to obtain a period of market and/or data exclusivity that would have the effect of postponing the entry into the
marketplace of a competitor's generic product. For example, in the EU, if any of Madrigal's products receive marketing approval in the European Economic Area, or EEA which is comprised of the 28
member states of the
EU plus Norway, Iceland and Liechtenstein, Madrigal expects that it will benefit from eight years of data exclusivity and an additional two years of marketing exclusivity. An additional one-year
extension
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of
marketing exclusivity is possible if during the data exclusivity period, Madrigal obtains an authorization for one or more new therapeutic indications that is deemed to bring a significant clinical
benefit compared to existing therapies. The data exclusivity period begins on the date of the product's first marketing authorization in the EU and prevents biosimilars from relying on the holder of
the marketing authorization for the reference biological medicine's pharmacological, toxicological and clinical data for a period of eight years. After eight years, a biosimilar product application
may be submitted and the sponsoring companies may rely on the marketing authorization holder's data. However, a biosimilar medicine cannot launch until 2 years later (or a total of ten years
after the first marketing authorization in the EU of the innovator product), or 3 years later (or a total of eleven years after the first marketing authorization in the EU of the innovator
product) if the marketing authorization holder obtains marketing authorization for a new indication with significant clinical benefit within the eight year data exclusivity period.
As
in the United States, a sponsor may apply for designation of a product as an orphan drug for the treatment of a specific indication in the EU before the application for marketing
authorization is made. Orphan drugs in Europe enjoy economic and marketing benefits, including up to ten years of market exclusivity for the approved indication unless another applicant can show that
its product is safer, more effective or otherwise clinically superior to the orphan-designated product.
Reimbursement
Sales of pharmaceutical products depend in significant part on the availability of third-party reimbursement. Third-party payors
include government healthcare programs, managed care providers, private health insurers and other organizations. These third-party payors are increasingly challenging the price and examining the
cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products. Madrigal may need to conduct
expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of its products. Madrigal's product candidates may not be considered cost-effective. It is time consuming and
expensive to seek reimbursement from third-party payors. Reimbursement may not be available or sufficient to allow Madrigal to sell its products on a competitive and profitable basis.
In
addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from
country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide
reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or
indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for
pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Madrigal's products. Historically, products launched in the European Union do not follow price structures
of the United States and generally tend to be significantly lower.
General Corporate Information
Madrigal was incorporated in Delaware in September 2011. On September 14, 2011, Madrigal entered into an asset purchase
agreement with Via (assignment for the benefit of creditors), LLC, or Via LLC, as assignee for the benefit of creditors of VIA, and an assignment and issuance agreement with investment
entities affiliated with Bay City Capital, whereby Via LLC transferred ownership of all right, title and interest in and to all tangible and intangible assets of VIA to Madrigal in exchange for
Madrigal's assumption of $23.4 million of outstanding convertible notes of VIA. Madrigal's principal executive offices are located at 500 Office Center Drive, Suite 400, Fort Washington,
PA 19034. Madrigal's website address is www.madrigalpharma.com. No portion of Madrigal's website is incorporated by reference into this proxy statement.
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SYNTA MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
For Synta's management's discussion and analysis of financial condition and results of operations, please refer to Item 7 set
forth in the Synta 10-K and Item 2 set forth in the Synta 10-Q, which sections are incorporated by reference herein. The discussion and analysis of financial condition and results of operations
sections should be read together with the section entitled
"Selected Historical and Unaudited Pro Forma Condensed Combined Financial DataSelected Historical Financial Data of Synta" in this proxy statement and the consolidated financial
statements of Synta and accompanying notes appearing in the Synta 10-K and Synta 10-Q.
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK OF SYNTA
For quantitative and qualitative disclosures about Synta's market risk, please refer to Item 7A set forth in the Synta 10-K and
Item 2 set forth in the Synta 10-Q, which sections are incorporated by reference herein.
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MADRIGAL MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of financial condition and results of operations should be read together
with Madrigal's financial statements and the related notes appearing elsewhere in this proxy statement. In addition to historical information, the following discussion contains forward-looking
statements that involve risks and uncertainties. Please see "Forward-Looking Statements" on page 61 for additional factors relating to such statements, and see "Risk Factors" beginning on
page 26 for a discussion of certain risk factors applicable to Madrigal's business, financial condition and results of operation. Operating results are not necessarily indicative of results
that may occur in future periods.
Overview
Madrigal is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutic
candidates for the treatment of cardiovascular, metabolic and liver diseases. Madrigal's lead product candidate, MGL-3196, is a proprietary, liver-directed, selective THR-ß agonist that
can potentially be used to treat a number of disease states with high unmet medical need. Madrigal is developing MGL-3196 for NASH and is planning to conduct a Phase 2 clinical trial in this
indication. Madrigal is also developing MGL-3196 for dyslipidemia, particularly genetic dyslipidemias such as FH, including both homozygous and heterozygous forms of the disease. Madrigal is planning
to conduct a Phase 2 clinical trial in HeFH patients and to conduct a proof-of-concept clinical trial in HoFH patients. MGL-3196 is a once-daily oral pill that has been studied in three
completed Phase 1 trials in a total of 115 subjects. MGL-3196 appeared to be safe and well-tolerated in these trials, which included a single ascending dose trial, a multiple ascending dose
trial, and a drug interaction trial with a statin.
Madrigal
has no products approved for commercial sale and has not generated any revenues from product sales since its inception in 2011. From inception to March 31, 2016, Madrigal
has raised net cash proceeds of approximately $15.5 million to fund operations, primarily from private placement offerings of debt and equity securities.
Madrigal
has never been profitable and has incurred significant operating losses in each year since inception. Net losses for the three months ended March 31, 2016 and 2015 were
$1.7 million and $1.4 million, respectively, and net losses for the years ended December 31, 2015 and 2014 were $6.8 million and $4.5 million, respectively.
Substantially all of Madrigal's operating losses resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its
operations. As of March 31, 2016, Madrigal had a working capital deficit of $50.6 million, consisting primarily of approximately $50.3 million of principal and accrued, but
unpaid, interest under outstanding convertible notes, $23.4 million of which Madrigal assumed from VIA pursuant to an assignment and issuance agreement dated September 14, 2011 between
Madrigal and investment entities affiliated with Bay City Capital. Madrigal expects to continue to incur significant expenses and increasing operating losses for at least the next several years as it
continues the clinical development of, and seeks regulatory approval for, MGL-3196 and other product candidates Madrigal may develop. Accordingly, Madrigal will continue to require substantial
additional capital to continue its clinical development and potential commercialization activities. The amount and timing of Madrigal's future funding requirements will depend on many factors,
including the timing and results of its clinical development efforts.
Recent Developments
On April 13, 2016, Madrigal entered into the Merger Agreement pursuant to which it will merge with Synta in an all-stock
transaction. Subject to the terms and conditions of the Merger Agreement, at the closing of the transaction, Synta will be renamed "Madrigal Pharmaceuticals, Inc."
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Concurrent
with the execution of the Merger Agreement, a Madrigal related party investor syndicate committed to invest $9.0 million in Madrigal prior to the closing of the Merger.
Madrigal expects the proceeds from this financing, along with net cash that Synta expects to have upon consummation of the merger, to fund the combined company's operations through the fourth quarter
of 2017. Madrigal plans to conduct two approximately 100 patient Phase 2 clinical trials commencing in the third quarter of 2016 that will extend into mid- to late 2017, one clinical trial in
patients with NASH and one clinical trial in patients with HeFH. Madrigal is also planning a smaller proof-of-concept trial in HoFH. Madrigal will conduct parallel studies in manufacturing and
toxicology in accordance with standard pharmaceutical development requirements.
On
a pro forma basis, based upon the number of shares of Synta common stock to be issued in the merger, Synta equityholders will own approximately 36% of the combined company and
Madrigal securityholders will own approximately 64% of the combined company (with Bay City Capital and its affiliates, Madrigal's largest securityholder, owning approximately 52.5% of the combined
company's outstanding shares of common stock immediately following the closing of the merger). The transaction has been approved by the board of directors of both companies and by the stockholders of
Madrigal. The merger is expected to close in the third quarter of 2016, subject to the approval of the stockholders of Synta and other customary closing conditions, as detailed in the Merger
Agreement.
In
connection with the merger, Madrigal will be deemed to be the accounting acquirer because the stockholders of Madrigal will effectively control the combined company following the
merger. The merger will be treated as a reverse acquisition.
Basis of Presentation
Research and Development Expenses
Research and development expenses primarily consist of costs associated with Madrigal's research activities, including the preclinical
and clinical development of Madrigal's product candidates. Madrigal expenses research and development expenses as incurred. Madrigal contracts with clinical research organizations to manage its
clinical trials under agreed upon budgets for each study, with oversight by its clinical program managers. Madrigal accounts for nonrefundable advance payments for goods and services that will be used
in future research and development activities as expenses when the service has been performed or when the goods have been received. Manufacturing expense includes costs associated with drug
formulation development and clinical drug production. Madrigal does not track employee and facility related research and development costs by project, as it typically uses its employee and
infrastructure resources across multiple research and development programs. Madrigal believes that the allocation of such costs would be arbitrary and not be meaningful.
Madrigal's
research and development expenses consist primarily of:
-
-
external expenses paid to clinical trial sites, contract research organizations, laboratories, database software and consultants that
conduct clinical trials;
-
-
expenses related to development and the production of nonclinical and clinical trial supplies, including fees paid to contract
manufacturers;
-
-
expenses related to preclinical studies;
-
-
expenses related to compliance with drug development regulatory requirements; and
-
-
other allocated expenses, which include direct and allocated expenses for depreciation of equipment and other supplies.
Madrigal
expects to continue to incur substantial expenses related to its development activities for the foreseeable future as it conducts its Phase 2 clinical program,
manufacturing and toxicology studies.
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Product
candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and
duration of later-stage clinical trials, additional drug manufacturing requirements, and later stage toxicology studies such as carcinogenicity studies. Madrigal's research and development expenses
increased between 2014 and 2015, and Madrigal expects that its research and development expenses will increase substantially in the future. The process of conducting preclinical studies and clinical
trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate is affected by numerous factors, including preclinical data, clinical
data, competition, manufacturing capability and commercial viability. Accordingly, Madrigal may never succeed in achieving marketing approval for any of its product candidates.
Completion
dates and costs for Madrigal's clinical development programs as well as its research program can vary significantly for each current and future product candidate and are
difficult to predict. As a result, Madrigal cannot estimate with any degree of certainty the costs it will incur in connection with development of its product candidates at this point in time.
Madrigal anticipates it will make determinations as to which programs and product candidates to pursue and how much funding to direct to each program and product candidate on an ongoing basis in
response to the scientific success of early research programs, results of ongoing and future clinical trials, its ability to enter into
collaborative agreements with respect to programs or potential product candidates, as well as ongoing assessments as to each current or future product candidate's commercial potential.
Research
and development expenses by major programs or categories were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
2015
|
|
2014
|
|
Clinical studies(1)
|
|
$
|
544
|
|
$
|
22
|
|
Preclinical studies(1)
|
|
|
1,029
|
|
|
498
|
|
Contract manufacturing
|
|
|
456
|
|
|
30
|
|
Internal and unallocated research and development expense
|
|
|
398
|
|
|
227
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2,427
|
|
$
|
777
|
|
-
(1)
-
Clinical
and preclinical studies reflect expenditures for a series of Phase 1 clinical studies, Phase 2-enabling preclinical GLP toxicology
studies and drug manufacturing studies to support further clinical development, including API manufacturing and drug product development studies, drug metabolism studies, acute, subchronic and chronic
animal toxicology studies and other safety pharmacology and toxicology studies.
General and Administrative Expenses
General and administrative expenses consist primarily of the costs associated with management costs, obtaining and maintaining
Madrigal's patent portfolio, professional fees for accounting, auditing, consulting and legal services, and allocated overhead expenses.
Madrigal
expects that its general and administrative expenses may increase in the future as it expands its operating activities, maintains and expands its patent portfolio and incurs
additional costs associated with the pending merger, the preparation of becoming a merged public company and maintaining compliance with exchange listing and SEC requirements. Madrigal expects these
potential increases will likely include management costs, legal fees, accounting fees, directors' and officers' liability insurance premiums and expenses associated with investor relations.
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Other Income (Expense), Net
Other income (expense), net consists primarily of interest expense resulting from Madrigal's convertible debt. Interest expense
consists of non-cash interest expense related to Madrigal's convertible notes.
Income Taxes
Madrigal has incurred net losses and has not recorded any U.S. federal or state income tax benefits for the losses as they have been
offset by valuation allowances.
As
of December 31, 2015 and 2014, Madrigal had federal and state tax net operating loss carryforwards of approximately $19.2 million and $12.2 million, respectively,
which begin to expire in 2031 for federal and 2035 for state unless previously utilized. As of December 31, 2015, Madrigal had federal research and development tax credit carryforwards of
approximately $0.5 million. The federal research and development tax credit carryforwards will expire in 2032.
Madrigal
expects the future utilization of net operating loss and tax credit carryforwards to be limited due to changes in ownership and to the current development-stage nature of
Madrigal. In general, if Madrigal experiences a greater than 50% aggregate change in ownership of certain significant stockholders or groups over a three-year period, or a Section 382 ownership
change, utilization of its pre-change net operating loss carryforwards would be subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended, and similar
state laws. The annual limitation generally is determined by multiplying the value of Madrigal stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term
tax-exempt rate. Such limitations may result in expiration of a portion of Madrigal operating loss carryforwards before it can use them and may be substantial. Madrigal has recorded a valuation
allowance on all of its deferred tax assets, including its deferred tax assets related to its net operating loss and research and development tax credit carryforwards as it is currently more likely
than not that Madrigal will not be able to realize its deferred tax assets.
Critical Accounting Policies and Significant Judgments and Estimates
Madrigal's management's discussion and analysis of its financial condition and results of operations are based on its financial
statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires Madrigal to make estimates and
judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities at the date of the financial statements. On an ongoing basis,
Madrigal evaluates its estimates and judgments, including those related to accrued research and development expenses. Madrigal bases its estimates on historical experience, known trends and events,
and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that
are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.
While
Madrigal's significant accounting policies are described in more detail in the notes to its financial statements appearing elsewhere in this proxy statement, Madrigal believes the
following accounting policies are the most critical for fully understanding and evaluating its financial condition and results of operations.
Research and Development Expenses
Madrigal recognizes research and development expenses as incurred, typically estimated based on an evaluation of the progress to
completion of specific tasks using data such as patient enrollment,
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clinical
site activations, manufacturing steps completed, or information provided by vendors on their actual costs incurred. Madrigal determines the estimates by reviewing contracts, vendor agreements
and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to
be paid for such services. These estimates are made as of each balance sheet date based on facts and circumstances
known to Madrigal at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, Madrigal will adjust the estimate accordingly. Nonrefundable
advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities,
are capitalized as prepaid expenses and recognized as expense in the period that the related goods are consumed or services are performed.
Madrigal
may pay fees to third-parties for clinical, non-clinical and manufacturing services that are based on contractual milestones that may result in uneven payment flows. There may
be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the research and development expense.
Deferred Tax Assets & Valuation Allowance
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the
deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary
differences become deductible. As there is no assurance of future taxable income, a full valuation allowance has been established to offset the deferred tax assets. Changes in the deferred tax asset
are recorded as an income tax benefit or expense in the statements of operations.
The
Internal Revenue Code, or IRC, limits the amounts of net operating loss carryforwards that a company may use in any one year in the event of certain cumulative changes in ownership
over a three-year period as described in Section 382 of the IRC. Such change in ownership could be triggered by subsequent sales of securities by Madrigal or its stockholders and could limit
Madrigal's utilization of the net operating loss carryforwards. The deferred tax asset related to the net operating loss carryforwards reflected in the financial statements could be affected by this
limitation.
Results of Operations
Comparison of Three Months Ended March 31, 2016 and 2015
The following table sets forth the key components of Madrigal's results of operations for the three months ended March 31, 2016
and 2015 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
|
|
Increase/
(Decrease)
|
|
|
|
2016
|
|
2015
|
|
Research and Development Expenses
|
|
$
|
516
|
|
$
|
344
|
|
$
|
172
|
|
General and Administrative Expenses
|
|
|
222
|
|
|
196
|
|
|
26
|
|
Interest Expense
|
|
|
975
|
|
|
843
|
|
|
132
|
|
Research and Development Expenses.
Madrigal's research and development expenses were $0.5 million for the three months ended
March 31,
2016 compared to $0.3 million for the same period in 2015. The increase in research and development expenses of $0.2 million in 2016 was primarily due to increased expenses for
Madrigal's clinical and preclinical development programs for MGL-3196. Madrigal expects its research and development expenses to increase over time as Madrigal advances its clinical and preclinical
development programs for MGL-3196.
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General and Administrative Expenses.
General and administrative expenses were $0.2 million for the three months ended
March 31, 2016
which was only slightly higher than the same period in 2015. The modest increase in general and administrative expenses in 2016 resulted from increased expenditures for legal, finance, accounting and
information management services relating to the merger with Synta. Madrigal believes general and administrative expenses may increase over time as it advances its programs,
increases its headcount and operating activities and incurs expenses associated with being a public company.
Interest Expense.
Interest expense increased from $0.8 million for the three months ended March 31, 2015 to $1.0 million
for the
same period in 2016. The increase in interest expense of $0.1 million was due to an increase in interest associated with the issuance of $2.5 million in convertible notes during the
period from April 1, 2015 to March 31, 2016 and incremental interest on previously outstanding convertible notes. All of the convertible notes issued by Madrigal will be converted into
common stock pursuant to their terms immediately prior to completion of the merger.
Comparison of the Years Ended December 31, 2015 and 2014
The following table sets forth the key components of Madrigal's results of operations for the years ended December 31, 2015 and
2014 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
|
|
Increase/
(Decrease)
|
|
|
|
2015
|
|
2014
|
|
Research and Development Expenses
|
|
$
|
2,427
|
|
$
|
777
|
|
$
|
1,650
|
|
General and Administrative Expenses
|
|
|
806
|
|
|
548
|
|
|
257
|
|
Interest Expense
|
|
|
3,612
|
|
|
3,166
|
|
|
446
|
|
Research and Development Expenses.
Madrigal's research and development expenses were $2.4 million for the year ended
December 31, 2015
compared to $0.8 million for the same period in 2014. The increase in research and development expenses of $1.7 million in 2015 was primarily due to continuation of the preclinical
studies initiated by Madrigal in 2014, further API manufacturing studies and the completion of a Phase 1 clinical study in 2015. Madrigal expects research and development expenses to increase
over time as it advances its clinical and preclinical development programs for MGL-3196.
General and Administrative Expenses.
General and administrative expenses were $0.8 million for the year ended December 31,
2015
compared to $0.5 million for the same period in 2014. The increase in general and administrative expenses of $0.2 million in 2015 resulted from increased expenditures for a new patent,
additional legal and information management fees. Madrigal believes general and administrative expenses may increase over time as it advances its programs, increases its headcount and operating
activities and incurs expenses associated with being a public company.
Interest Expense, Net.
Interest expense increased from $3.2 million for the year ended December 31, 2014 to $3.6 million
for the
same period in 2015. The increase in interest expense of $0.4 million was due to an increase in interest associated with the issuance of $2.8 million in convertible notes and advances of
$0.5 million from a related party in 2015 and incremental interest on previously outstanding convertible notes. All of the convertible notes issued by Madrigal will be converted into common
stock pursuant to their terms immediately prior to completion of the merger.
Income Taxes
Madrigal has incurred net losses and has not recorded any United States federal or state income tax benefits for losses as valuation
allowances were deemed necessary.
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Liquidity and Capital Resources
Madrigal has incurred losses since inception and negative cash flows from operating activities for the three months ended
March 31, 2016 and 2015 and for the years ended December 31, 2015 and 2014. As of March 31, 2016, Madrigal had a working capital deficit of $50.6 million, consisting
primarily of approximately $50.3 million of principal and accrued, but unpaid, interest under outstanding convertible notes, $23.4 million of which Madrigal assumed from VIA as described
elsewhere in this section. Madrigal anticipates that it will continue to incur net losses for the foreseeable future as it continues research and development efforts of its product candidates, hires
additional staff, including clinical, scientific, operational, financial and management personnel, and incurs additional costs associated with being a public company.
Madrigal
has funded its operations primarily through private placement offerings of its debt and equity securities and cash advances. During the three months ended March 31, 2016
and 2015, Madrigal received net proceeds of $0.8 million and $1.1 million from the issuance of convertible notes. During the years ended December 31, 2015 and 2014, Madrigal
received net proceeds of $2.8 million and $1.4 million, respectively, from the issuance of convertible notes and $0.5 million and $0, respectively of cash advances from a related
party. As of March 31, 2016, Madrigal had cash and cash equivalents of $0.6 million. Madrigal's independent registered public accounting firm included an explanatory paragraph in its
report on Madrigal's financial statements as of and for the year ended December 31, 2015, describing the existence of substantial doubt about Madrigal's ability to continue as a going
concern. This uncertainty arose from its results of operations and financial condition and the conclusion that it did not have sufficient cash to operate for 12 months from year-end.
Madrigal
plans to continue to fund its research and development and other operating expenses, and the associated losses from operations, through working capital obtained upon
consummation of the merger, future issuances of debt and equity securities and potential collaborations or strategic partnerships with other entities. The capital raises from issuances of convertible
debt and equity securities could result in additional dilution to Madrigal's stockholders. In addition, Madrigal's incurrence of additional debt could result in debt service obligations and operating
and financing covenants that would restrict its operations. Madrigal can provide no assurance that financing will be available in the amounts it needs or on terms acceptable to it, if at all. If
Madrigal is not able to secure adequate additional working capital when it becomes needed, Madrigal may be required to make reductions in spending, extend payment terms with suppliers, liquidate
assets where possible and/or suspend or curtail planned research programs. Any of these actions could materially harm Madrigal's business.
Concurrent
with the execution of the Merger Agreement, a Madrigal related party investor syndicate committed to invest $9.0 million in Madrigal. Madrigal expects the proceeds from
this financing, along with net cash held by Synta upon consummation of the merger, to fund operations of the combined company through the fourth quarter of 2017.
Cash Flows
The following table provides a summary of the net cash flow activity for each of the periods set forth below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Month
Ended
March 31,
|
|
Year Ended
December 31,
|
|
|
|
2016
|
|
2015
|
|
2015
|
|
2014
|
|
Net cash used in operating activities
|
|
$
|
(438
|
)
|
$
|
(483
|
)
|
$
|
(3,142
|
)
|
$
|
(1,397
|
)
|
Net cash provided by financing activities
|
|
|
750
|
|
|
1,050
|
|
|
3,300
|
|
|
1,375
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
312
|
|
|
567
|
|
|
158
|
|
|
(22
|
)
|
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Comparison of the Three Months Ended March 31, 2016 and 2015
Cash used in operating activities for the three months ended March 31, 2016 consisted of a net loss of $1.7 million,
which was offset primarily by non-cash items such as PIK interest expense on convertible notes of $1.0 million and an increase in accounts payable of $0.4 million. Cash used in operating
activities for the three months ended March 31, 2015 consisted of a net loss of
$1.4 million, which was offset primarily by non-cash items such as PIK interest expense on convertible notes of $0.8 million. Net cash provided by financing activities for the three
months ended March 31, 2016 consisted of net proceeds from the issuance of $0.8 million of related party convertible notes. Net cash provided by financing activities for the three months
ended March 31, 2015 consisted of net proceeds from the issuance of $1.1 million of related party convertible notes.
Comparison of the Years Ended December 31, 2015 and 2014
Cash used in operating activities for the year ended December 31, 2015 consisted of a net loss of $6.8 million, which was
offset primarily by non-cash items such as PIK interest expense on convertible notes of $3.6 million. Cash used in operating activities for the year ended December 31, 2014 consisted of
a net loss of $4.5 million, which was offset primarily by non-cash items such as PIK interest expense on convertible notes of $3.2 million. Net cash provided by financing activities for
the year ended December 31, 2015 consisted of net proceeds from the issuance of $2.8 million of related party convertible notes and $0.5 million in advances from a related party.
Net cash provided by financing activities for the year ended December 31, 2014 consisted of net proceeds from the issuance of $1.4 million of related party convertible notes.
Operating Capital Requirements
To date, Madrigal has not generated any revenues, and does not have any approved products. Madrigal does not know when, or if, it will
generate any revenue. Madrigal does not expect to generate significant revenue unless and until we obtain regulatory approval of and commercialize one of its current or future product candidates.
Madrigal anticipates that it will continue to incur losses for the foreseeable future, and it expects the losses to increase as it continues the development of, and seeks regulatory approvals for, its
product candidates, and begins to commercialize any approved products. Madrigal is subject to all of the risks incident to the development of new therapeutic products, and it may encounter unforeseen
expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. Upon closing of the merger, Madrigal expects to incur additional costs associated with
operating as a public company.
Based
upon Madrigal's operating plans, Madrigal does not currently have sufficient working capital to fund planned operating expenses through the fourth quarter of 2016 without
additional cash. However, on April 13, 2016, certain of Madrigal's investors have committed $9.0 million of financing before or concurrent with the completion of the merger. Madrigal
expects the proceeds from this financing, along with net cash held by Synta upon consummation of the merger, to fund the operations of the combined company through the fourth quarter of 2017. Madrigal
will require additional capital to complete the
development and commercialization of MGL-3196, if approved, and may also need to raise additional funds to pursue other development activities related to additional product candidates.
Until
such time, if ever, as Madrigal can generate substantial revenues, it expects to finance its cash needs through a combination of equity or debt financings, collaborations,
strategic partnerships or licensing arrangements. In any event, Madrigal does not expect to achieve revenue prior to the use of cash resulting from the financing and combined company cash. Madrigal
does not have any committed external sources of funds other than the $9 million commitment described above. Additional capital may not be available on reasonable terms, if at all. To the extent
that Madrigal raises additional capital through the sale of stock or convertible debt securities, the ownership interest of its stockholders will
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be
diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of its common stockholders. Debt financing, if available, may involve
agreements that include increased fixed payment obligations and covenants limiting or restricting Madrigal's ability to take specific actions, such as incurring additional debt, making capital
expenditures, declaring dividends, selling or licensing intellectual property rights and other operating restrictions that could adversely impact its ability to conduct its business. If Madrigal
raises additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, it may have to relinquish valuable rights to MGL-3196 or its other product
candidates, including its other technologies, future revenue streams or research programs, or grant licenses on terms that may not be favorable to it. If Madrigal is unable to raise additional funds
when needed, it may be required to delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and commercialize MGL-3196 or its other
product candidates even if it would otherwise prefer to develop and commercialize such product candidates itself.
Contractual Obligations and Commitments
Convertible Notes
As of March 31, 2016, Madrigal had aggregate principal amount of $36.9 million plus accrued and unpaid interest on
convertible notes issued by Madrigal to related party investment entities affiliated with Bay City Capital, totaling $50.3 million with a maturity date of December 31, 2016. On
April 13, 2016, Madrigal entered into an amended and restated note purchase agreement, or the 2016 purchase agreement, with certain of Madrigal's investors, including Bay City Capital, whereby
such investors committed $9.0 million of financing before or concurrent with the completion of the merger. Pursuant to the 2016 purchase agreement, Bay City Capital agreed to waive all accrued
interest on the $36.9 million of convertible notes incurred prior to April 13, 2016. Bay City Capital also agreed that no interest shall accrue on such convertible notes from the date of
the 2016 purchase agreement through the date on which either the merger is consummated or the Merger Agreement is terminated, and the other investor parties to the 2016 purchase agreement agreed that
no interest shall accrue on the convertible notes issued thereunder from the date of the 2016 purchase agreement through the date on which either the merger is consummated or the Merger Agreement is
terminated. In addition, all of the convertible notes issued by Madrigal will be converted into common stock pursuant to their terms immediately prior to completion of the merger. As of
April 13, 2016, the total convertible notes outstanding amounted to $39.5 million.
Contractual Arrangements
In December 2008, VIA entered into a research, development and commercialization agreement with Roche. As described elsewhere in this
proxy statement, Madrigal subsequently assumed all of VIA's rights in, to and under, and all of VIA's obligations under, the agreement. Under the agreement, Roche assigned all patent rights relating
to MGL-3196 to Madrigal, as successor-in-interest to VIA, and granted Madrigal an exclusive license to use certain know-how relating to MGL-3196 in exchange for consideration consisting of an upfront
payment, milestone payments, the remainder of which total $10.8 million and are tied to the future commencement of Phase 2 and Phase 3 clinical trials and future regulatory
approval in the United States and Europe of a product developed from MGL-3196, and single-digit royalty payments based on net sales of products developed from MGL-3196, subject to certain reductions.
In 2011, Madrigal commenced Phase I clinical trials and subsequently paid Roche a related milestone payment. To date, Madrigal has not achieved any additional product development or regulatory
milestones under the Roche Agreement.
Madrigal
enters into contracts in the normal course of business with contract research organizations and clinical sites for the conduct of clinical trials, preclinical and clinical
studies, professional consultants and other vendors for clinical supply manufacturing or other services. These
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contracts
generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments.
Off-Balance Sheet Arrangements
Madrigal does not have any off-balance sheet arrangements as defined in the rules and regulations of the SEC.
Quantitative and Qualitative Disclosures about the Market Risk of Madrigal
Interest Rate Risk
Madrigal's cash and cash equivalents as of March 31, 2016 consisted of readily available checking and money market funds.
Madrigal's primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the short-term nature of the
instruments in Madrigal's portfolio, a sudden change in market interest rates would not be expected to have a material impact on Madrigal's financial condition and/or results of operations. Madrigal
does not believe that its cash or cash equivalents have significant risk of default or illiquidity. While Madrigal believes its cash and cash equivalents do not contain excessive risk, Madrigal cannot
provide absolute assurance that in the future its investments will not be subject to adverse changes in market value. In addition, Madrigal maintains significant amounts of cash and cash equivalents
at one or more financial institutions that are in excess of federally insured limits.
Effects of Inflation
Inflation generally affects Madrigal by increasing its clinical trial costs. Madrigal does not believe that inflation and changing
prices had a significant impact on its results of operations for any periods presented herein.
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MANAGEMENT FOLLOWING THE MERGER
Executive Officers and Directors
Termination of Current Executive Officers of Synta
The employment of the current executive officers of Synta, other than Marc R. Schneebaum, is expected to be terminated immediately
prior to the completion of the merger, however, if necessary, certain executive officers may provide transitional services to the combined company following the completion of the merger.
Executive Officers and Directors of the Combined Company Following the Merger
The combined company's board of directors will initially be fixed at seven (7) members, consisting of (i) one member
designated by Synta, Keith R. Gollust, the current Chairman of the board of directors of Synta, (ii) one member to be mutually agreed upon by Synta and Madrigal meeting the SEC and NASDAQ Stock
Market independence requirements, and (iii) five members designated by Madrigal, namely Paul A. Friedman, M.D., who will be the Chairman, Rebecca Taub, M.D., Fred Craves, Ph.D., who will be the
lead director and who currently is the founder and a managing director of Bay City Capital (which it and its affiliates will own approximately 52.5% of the combined company's outstanding shares of
common stock immediately following the closing of the merger); Kenneth M. Bate and one additional Madrigal designee who meets the SEC and NASDAQ Stock Market independence requirements. The staggered
structure of the current Synta board of directors will remain in place for the combined company following the completion of the merger, provided that Keith R. Gollust will be re-appointed as a
Class III director.
The
following table lists the names and ages as of May 2, 2016 and positions of the individuals who are expected to serve as executive officers and directors of the combined
company upon completion of the merger:
|
|
|
|
|
|
Name
|
|
Age
|
|
Position(s)
|
Executive Officers
|
|
|
|
|
|
Paul A. Friedman, M.D.
|
|
|
73
|
|
Chief Executive Officer, Chairman of the Board and Class I Director
|
Rebecca Taub, M.D.
|
|
|
64
|
|
Chief Medical Officer, Executive Vice President, Research & Development and Class II Director
|
Marc R. Schneebaum
|
|
|
62
|
|
Chief Financial Officer
|
Non-Employee Directors
|
|
|
|
|
|
Fred B. Craves, Ph.D.
|
|
|
70
|
|
Lead Director and Class II Director
|
Keith R. Gollust
|
|
|
70
|
|
Class III Director
|
Kenneth M. Bate
|
|
|
65
|
|
Class I Director
|
Executive Officers
Paul A. Friedman, M.D.
, served as a member of Synta's board of directors from March
2014 until April 2016. Dr. Friedman served as the Chief Executive Officer and a Director of Incyte Corporation from November 2001 until his retirement in January 2014. From 1994 to 1998,
Dr. Friedman served as President of Research & Development for the DuPont-Merck Pharmaceutical Company; and from 1998 to 2001 as President of DuPont Pharmaceuticals Research
Laboratories, a
wholly-owned subsidiary of the DuPont Company. From 1991 to 1994, he served as Senior Vice President at Merck Research Laboratories. Prior to his tenures at Merck and DuPont, Dr. Friedman was
an Associate Professor of Medicine and Pharmacology at Harvard Medical School. Dr. Friedman is a diplomat of the American Board of Internal Medicine and a member of the American Society of
Clinical Investigation. Dr. Friedman currently sits on the board of directors of Cerulean Pharma Inc., a publicly traded
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pharmaceutical
company, Verastem, Inc., a publicly traded pharmaceutical company, Incyte Corporation, a publicly traded pharmaceutical company, and Gliknik, Inc. He has previously served
on the board of directors of Auxilium Pharmaceuticals Inc., a publicly traded pharmaceutical company, and Durata Therapeutics, Inc., a publicly traded pharmaceutical company.
Dr. Friedman received his A.B. in Biology from Princeton University and his M.D. from Harvard Medical School. We believe that Dr. Friedman is qualified to serve as the Chief Executive
Officer and Chairman of the board of the combined company due to his management, research and development experience and his experience as an executive and director of life sciences companies.
Rebecca Taub, M.D.
, has served as a member of Madrigal's board of directors and as Chief Executive Officer since Madrigal was founded in
September 2011. Prior to joining Madrigal, Dr. Taub served as Senior Vice President, Research and Development of VIA Pharmaceuticals from 2008 to 2011 and as Vice President, Research, Metabolic
Diseases at Hoffmann-La Roche from 2004 to 2008. In those positions, Dr. Taub oversaw clinical development and drug discovery programs in cardiovascular and metabolic diseases including the
conduct of a series of Phase I and II proof of conduct clinical trials. Dr. Taub led drug discovery including target identification, lead optimization and advancement of preclinical
candidates into clinical development. From 2000 through 2003, Dr. Taub worked at Bristol-Myers Squibb Co. and DuPont Pharmaceutical Company, in a variety of positions, including
Executive Director of CNS and metabolic diseases research. Before becoming a pharmaceutical executive, Dr. Taub was a tenured Professor of Genetics and Medicine at the University of
Pennsylvania, and remains an adjunct professor. Dr. Taub is the author of more than 120 research articles. Before joining the faculty of the University of Pennsylvania, Dr. Taub served
as an Assistant Professor at the Joslin Diabetes Center of Harvard Medical School, Harvard University and an associate investigator with the Howard Hughes Medical Institute. Dr. Taub received
her M.D. from Yale University School of Medicine and B.A. from Yale College. We believe that Dr. Taub is qualified to serve as Chief Medical Officer, Executive Vice Preseident, Research and
Development and a member of the board of the combined company due to her extensive experience as a pharmaceutical executive heading up major development programs in NASH.
Non-Employee Directors
Fred Craves, Ph.D.
, has served as a member of Madrigal's board of directors since
Madrigal was founded in September 2011. Dr. Craves is an investment partner, Managing Director and co-founder of Bay City Capital, and has served as a member of the board of directors and
Chairman of the executive committee of Bay City Capital since June 1997. Prior to founding Bay City Capital in 1996, Dr. Craves founded Burrill & Craves, a merchant bank focused on
biotechnology and emerging pharmaceutical companies, in 1994. Dr. Craves served as Executive Vice President of Schering Berlin, Inc., a pharmaceutical company, and Chief Executive
Officer and President of Berlex Laboratories, Inc., a research, development and manufacturing organization, from 1990 to 1993. Dr. Craves was also the founding Chairman and Chief
Executive Officer of Codon, Inc. and co-founder of Creative Biomolecules, both biotechnology companies. Dr. Craves is a member of the board of directors of several privately held
companies. Dr. Craves currently serves as a member of the board of directors of Dermira, Inc. and has previously served as a member of the board of directors of VIA
Pharmaceuticals, Inc. from August 2004 to September 2011 and Poniard Pharmaceuticals, Inc. from June 1993 to September 2013. He also serves as a member of the J. David Gladstone
Institutes' Advisory Council and is a member of the board of trustees of Loyola Marymount University in Los Angeles. Dr. Craves earned a B.S. degree in biology from Georgetown University, an
M.S. in biochemical pharmacology from Wayne State University and a Ph.D. in pharmacology and experimental toxicology from the University of California, San Francisco. We believe that Dr. Craves
is qualified to serve as a member of the board of the combined company due to his investment experience and extensive knowledge of the life sciences industry.
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Table of Contents
Keith R. Gollust
, has served as a member of Synta's board of directors since July 2002 and has been the Chairman since September 2002.
Mr. Gollust is a private investor and President of Gollust Management, Inc., the general partner of Wyandanch Partners, an investment partnership. In the past, Mr. Gollust has
served as a director of numerous public and private companies. Mr. Gollust currently serves as a director of CastleLine Holdings, LLC, an insurance holding company and Script
Relief, LLC, a discount prescription drug company. He also is a member of the Board of Trustees of the Julliard School. Mr. Gollust received a B.A. from Princeton University and an
M.S.I.A. from Carnegie Mellon University. We believe that Mr. Gollust is qualified to serve as a member of the board of the combined company due to his experience as managing general partner of
various investment partnerships which have given him the responsibility for investing over $1 billion as a fiduciary.
Kenneth M. Bate
, will serve as a director of the combined company following the effective time of the merger. He currently works as an
independent consultant. Previously, Mr. Bate was the president and chief executive officer of Archemix Corp., a privately held biopharmaceutical company, a position he held from April 2009
through December 2011. From 2006 to April 2009, he served in various positions
at NitroMed, Inc., a public pharmaceutical company, most recently as President and Chief Executive Officer. From 2002 to 2005, Mr. Bate served as head of commercial operations and chief
financial officer at Millennium Pharmaceuticals, Inc., a biopharmaceutical company. Prior to joining Millennium Pharmaceuticals, Mr. Bate co-founded JSB Partners, LLC, a banking
and advisory services firm for biopharmaceutical and life sciences companies. From 1990 to 1996, Mr. Bate was employed with Biogen, Inc., a public biotechnology company, first as its
chief financial officer and then as head of the commercial organization responsible for launching its multiple sclerosis business. Mr. Bate currently serves on the board of AVEO
Pharmaceuticals, Inc., Catabasis Pharmaceuticals, Inc., Vanda Pharmaceuticals Inc., Genocea Biosciences, Inc. and Epizyme, Inc., each a public biopharmaceutical company and serves
on the board of TransMedics Inc., a privately held medical device company. During the last five years, Mr. Bate also served as chairman of the board of Cubist
Pharmaceuticals, Inc. and as a director of BioMarin Pharmaceutical Inc., each a public biopharmaceutical company. He holds a B.A. in Chemistry from Williams College and an M.B.A. from
The Wharton School of the University of Pennsylvania. We believe Mr. Bate's qualifications to serve on our board of directors include his operating, finance, commercial, transactional and
senior management experience in the industry, such as his experience as chief executive officer of Archemix and NitroMed, as head of commercial operations and chief financial officer at Millennium
Pharmaceuticals, and as chief financial officer and vice president of sales and marketing at Biogen, as well as his experience serving on the board of directors of other public companies in the life
sciences industry.
Controlled Company
For purposes of the NASDAQ Stock Market rules, it is expected that the combined company may qualify as a "controlled company," but we
do not intend to take advantage of any exemptions afforded to controlled companies. Controlled companies under NASDAQ rules are companies of which more than 50% of the voting power for the election of
directors is held by an individual, a group or another company. Bay City Capital may continue to control more than 50% of the combined voting power of our common shares upon completion of the merger
and may continue to have the right to designate a majority of the members of our board of directors for nomination for election and the voting power to elect such directors following this offering. A
controlled company may take advantage of certain exemptions from corporate governance requirements provided in the NASDAQ rules. Specifically, as a controlled company, the combined company would not
be required to have (i) a majority of independent directors, (ii) a nominating/corporate governance committee composed entirely of independent directors, or (iii) a compensation
committee composed entirely of independent directors. The controlled company exemption does not modify the independence requirements for the combined company's audit committee.
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Table of Contents
Board of Directors of the Combined Company Following the Merger
In accordance with Synta's certificate of incorporation and bylaws, Synta's board of directors currently consists of seven directors
divided into three staggered classes, with one class to be elected at each Annual Meeting to serve for a three-year term. The staggered structure of the board of directors will remain in place for the
combined company following the completion of the merger. At Synta's most recent annual stockholders meeting, held in 2015, Class II directors were elected. As a result, the term of the
Class I directors of the combined company is set to expire upon the election and qualification of successor directors at the Synta annual stockholders meeting in 2017, and the terms of the
Class III and Class I directors will expire upon the election and qualification of successor directors at the annual stockholders meetings in 2016 and 2018, respectively.
The
director classes for Synta are currently as follows:
-
-
Class I directors (term ending in 2017): Chen Schor, Donald W. Kufe, M.D. and William S. Reardon, C.P.A.;
-
-
Class II directors (term ending in 2018): Keith R. Gollust, Scott Morenstein and Robert N. Wilson; and
-
-
Class III director (term ending in 2016): Bruce Kovner
The
combined company's board of directors will initially be fixed at 7 (seven) members, consisting of (i) one member designated by Synta, Keith R. Gollust, the current Chairman of
the board of directors of Synta, (ii) one member to be mutually agreed upon by Synta and Madrigal meeting the SEC and NASDAQ Stock Market independence requirements, and (iii) five
members designated by Madrigal, namely Paul A. Friedman, M.D., who will be the Chairman, Rebecca Taub, M.D., Fred Craves, Ph.D., who will be the lead director and who currently is the founder and a
managing director of Bay City Capital (which it and its affiliates will own approximately 52.5% of the combined company's outstanding shares of common stock immediately following the closing of the
merger); Kenneth M. Bate and one additional Madrigal designee who meets the SEC and NASDAQ Stock Market independence requirements. The staggered structure of the current Synta board of directors will
remain
in place for the combined company following the completion of the merger, provided that Keith R. Gollust will be re-appointed as a Class III director.
Pursuant
to the terms of the Merger Agreement, it is anticipated that these directors will be appointed to the three staggered director classes of the combined company board of directors
as follows:
-
-
Class I directors (term ending 2017): Paul A. Friedman, M.D. and Kenneth M. Bate;
-
-
Class II directors (term ending 2018): Rebecca Taub, M.D. and Fred Craves, Ph.D.; and
-
-
Class III directors (term ending 2019): Keith R. Gollust, one mutual designee and one Madrigal designee.
There
are no family relationships among any of the current Synta directors and executive officers, and there are no family relationships, other than Dr. Friedman being the spouse
of Dr. Taub, as previously discussed, among any of the proposed combined company directors and officers. There are no arrangements or understandings with another person under which the
directors and executive officers of the combined company was or is to be selected as a director or executive officer. Additionally, no director or executive officer of the combined company is involved
in legal proceedings which require disclosure under Item 401 of Regulation S-K.
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Director Independence
NASDAQ's listing standards and Synta's Corporate Governance Guidelines require that the Synta board of directors consist of a majority
of independent directors, as determined under the applicable NASDAQ listing standard.
The
Synta board of directors believes that each of Kenneth M. Bate, Fred B. Craves, Ph.D. and Keith R. Gollust will qualify as an independent director following the completion of the
merger.
Committees of the Board of Directors
The Synta board of directors currently has, and following the completion of the merger will continue to have, the following committees:
an audit committee, a compensation committee, and a nominating and governance committee.
Audit Committee
The audit committee's role and responsibilities are set forth in the audit committee's written charter and include the authority
to:
-
-
approve and retain the independent auditors to conduct the annual audit of the company's books and records;
-
-
review the proposed scope and results of the audit;
-
-
review and pre-approve the independent auditor's audit and non-audit services rendered;
-
-
approve the audit fees to be paid;
-
-
review accounting and financial controls with the independent auditors and the company's financial and accounting staff;
-
-
review and approve transactions between the company and its directors, officers and affiliates;
-
-
recognize and prevent prohibited non-audit services;
-
-
establish procedures for complaints received by the company regarding accounting matters;
-
-
oversee internal audit functions, if any; and
-
-
prepare the report of the audit committee that the rules of the SEC require to be included in the company's annual meeting proxy
statements.
The
audit committee of the combined company is expected to retain these duties and responsibilities following the completion of the merger.
In
connection with the closing of the merger, the combined company's board of directors is expected to select members of the audit committee. To qualify as independent to serve on the
combined company's audit committee, the NASDAQ Stock Market listing standards and the applicable rules of the SEC require that a director does not accept any consulting, advisory, or other
compensatory fee from the combined company, other than for service as a director, or be an affiliated person of the combined company. Synta and Madrigal believe that, following completion of the
merger, the functioning of the combined company's audit committee will comply with the applicable requirements of the rules and regulations of The NASDAQ Stock Market. The audit committee financial
expert will be Kenneth M. Bate.
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Table of Contents
Compensation Committee
The compensation committee's role and responsibilities are set forth in the compensation committee's written charter and include the
authority to:
-
-
review and establish the compensation arrangements for management, including the compensation for the company's President and Chief
Executive Officer;
-
-
establish and review general compensation policies with the objective to attract and retain superior talent, to reward individual
performance and to achieve the company's financial goals;
-
-
administer the company's equity incentive plans;
-
-
review the Compensation Discussion and Analysis, or CD&A, prepared by management, discuss the CD&A with management and, based on such
review and discussions, recommend to the company's board of directors that the CD&A be included in the company's Annual Report on Form 10-K, annual meeting proxy statement, or any other
applicable filing as required by the SEC; and
-
-
prepare the report of the compensation committee that SEC rules require to be included in the company's annual meeting proxy
statement.
The
compensation committee of the combined company is expected to retain these duties and responsibilities following the completion of the merger.
In
connection with the closing of the merger, the combined company's board of directors is expected to select members of the compensation committee. To qualify as independent to serve on
the combined company's compensation committee, The NASDAQ Stock Market listing standards require a director not to accept any consulting, advisory, or other compensatory fee from the combined company,
other than for service on the combined company's board of directors, and that the combined company's board of directors consider whether a director is affiliated with the combined company and, if so,
whether such affiliation would impair the director's judgment as a member of the compensation committee. Synta and Madrigal believe that, after the completion of the merger, the composition of the
compensation committee will meet the requirements for independence under, and the functioning of such compensation committee will comply with any applicable requirements of the rules and regulations
of The NASDAQ Stock Market and of the SEC.
Nominating and Goverance Committee
The nominating and governance committee's role and responsibilities are set forth in the nominating and governance committee's written
charter and include the authority to:
-
-
identify and nominate members of the board of directors;
-
-
develop and recommend to the board of directors a set of corporate governance principles applicable to the company; and
-
-
oversee the evaluation of the board of directors and management.
Synta
and Madrigal believe that, after the completion of the merger, the composition of the nominating and governance committee will meet the requirements for independence under, and the functioning
of such nominating and governance committee will comply with any applicable requirements of the rules and regulations of The NASDAQ Stock Market.
Employment Arrangements with Dr. Friedman and Dr. Taub
Paul A. Friedman, M. D.
On April 13, 2016, Madrigal entered into a contingent employment agreement, or the Friedman Letter
Agreement, with
Paul A. Friedman, M. D. for the position of
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Table of Contents
Chairman
and Chief Executive Officer of the combined company following, and contingent upon, the completion of the merger. Under the terms of the Friedman Letter Agreement, Dr. Friedman will
receive an annual base salary of $400,000, an annual performance-based bonus of up to 50% of his base salary, and equity awards based upon the issued and outstanding shares of common stock of the
combined company, including 4,958,556 shares of restricted common stock and 9,917,113 stock options to purchase shares of common stock. The repurchase right relating to the foregoing shares of
restricted stock will lapse as to 25% of the shares on the business day immediately following the closing of the merger and the repurchase right on the remaining shares will lapse annually on the
first, second and third anniversaries of the closing of the merger. The foregoing stock options will vest as to 25% of the shares on the business day immediately following the closing of the merger
and then annually on the first, second and third anniversaries of the closing of the merger.
Dr. Friedman
is also entitled to severance benefits if terminated without "Cause" or if there is resignation for "Good Reason," consisting
of:
-
-
a severance payment equal 12 months of Dr. Friedman's then-current base salary and target bonus, and payable
(i) in a lump sum for such a Qualifying Separation if it occurs following a Change of Control (not including the merger with Synta) and (ii) in 12 equal monthly payments for all other
Qualifying Separations;
-
-
full vesting of restricted stock and stock options held by Dr. Friedman upon a Qualifying Separation (the mere occurrence of a
Change of Control is not enough to trigger this acceleration; a Qualifying Separation must occur); and
-
-
reimbursement of continuation of medical benefits for 12 months following a Qualifying Separation.
Dr. Friedman
has also entered into a customary indemnification agreement with Madrigal with respect to his service as an officer and director of Madrigal.
Rebecca Taub, M.D.
On April 13, 2016, Madrigal entered into a contingent employment agreement, or the Taub Letter Agreement, with
Rebecca
Taub, M. D., Madrigal's founder and current Acting Chief Executive Officer, for the position of Chief Medical Officer and Executive Vice President, Research & Development, of the combined
company following, and contingent upon, the completion of the merger. Under the terms of the Taub Letter Agreement, Dr. Taub will receive an annual base salary of $370,000, an annual
performance based bonus of up to 40% of her base salary and equity awards based upon the issued and outstanding shares of common stock of the combined company, including 991,711 shares of restricted
common stock and 4,958,556 stock options to purchase shares of common stock. The repurchase right relating to the shares of restricted stock will lapse as to 25% of the shares on the business day
immediately following the closing of the merger and the repurchase right on the remaining shares will lapse annually on the first, second and third anniversaries of the closing of the merger. The
stock options will vest as to 25% of the shares on the business day immediately following the closing of the merger and then annually on the first, second and third anniversaries of the closing of the
merger.
Dr. Taub
is also entitled to severance benefits if terminated without "Cause" or if there is resignation for "Good Reason" on the same terms as described above for
Dr. Friedman and has also entered into a customary indemnification agreement with Madrigal with respect to her service as an officer and director of Madrigal.
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RELATED PARTY TRANSACTIONS OF DIRECTORS AND EXECUTIVE
OFFICERS OF THE COMBINED COMPANY
Described below are the transactions and series of similar transactions since January 1, 2015 in
which:
-
-
the amounts involved exceeded or will exceed $120,000; and
-
-
any of the directors, executive officers, holders of more than 5% of capital stock (sometimes refer to as 5% stockholders below) or
any member of their immediate family had or will have a direct or indirect material interest.
For
information on members of the Synta board of directors and executive officers of Synta that have interests in the merger that may be different from stockholders of Synta, see "The
MergerInterests of the Synta Directors and Executive Officers in the Merger" beginning on page 90 of this proxy statement.
Synta Transactions
For a description of Synta's related party transactions, please refer to the section entitled "Certain Relationships and Related
Transactions" included in the description of Synta's business in Part III, Item 13 of the Synta 10-K, which is incorporated by reference herein.
Indemnification Agreements
Synta has entered into indemnification agreements with each of its executive officers and directors. Pursuant to the indemnification
agreements, Synta has agreed to indemnify and hold harmless these directors and officers to the fullest extent permitted by the DGCL. The agreements generally cover expenses that a director or officer
incurs or amounts that a director or officer becomes obligated to pay because of any proceeding to which he or she is made or threatened to be made a party or participant by reason of his or her
service as a current or former director, officer, employee or agent of Synta. The agreements also provide for the advancement of expenses to the directors and officers subject to specified conditions.
There are certain exceptions to Synta's obligation to indemnify the directors and officers, including any intentional malfeasance or act where the director or officer did not in good faith believe he
or she was acting in Synta's best interests, with
respect to "short-swing" profit claims under Section 16(b) of the 1934 Act and, with certain exceptions, with respect to proceedings that he or she initiates.
Change of Control and Severance Benefits Agreements
See "The MergerGolden Parachute Compensation" for a description of these agreements.
Policy for Approval of Related Person Transactions
Pursuant to the written charter of our audit committee, the audit committee is responsible for reviewing and approving, prior to our
entry into any such transaction, all transactions in which we are a participant and in which any of the following persons has or will have a direct or indirect material
interest:
-
-
our executive officers;
-
-
our directors;
-
-
the beneficial owners of more than 5% of our securities;
-
-
the immediate family members of any of the foregoing persons; and
-
-
any other persons whom the board of directors determines may be considered related persons.
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Table of Contents
For
purposes of these procedures, "immediate family members" means any child, stepchild, parent, stepparent, spouse, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law,
brother-in-law, or sister-in-law, and any person (other than a tenant or employee) sharing the household with the executive officer, director or 5% beneficial owner.
In
reviewing and approving such transactions, the audit committee shall obtain, or shall direct our management to obtain on its behalf, all information that the committee believes to be
relevant and important to a review of the transaction prior to its approval. Following receipt of the necessary information, a discussion shall be held of the relevant factors if deemed to be
necessary by the committee prior to approval. If a discussion is not deemed to be necessary, approval may be given by written consent of the committee. This approval authority may also be delegated to
the chairman of the audit committee in some circumstances. No related person transaction shall be entered into prior to the completion of these procedures.
The
audit committee or its chairman, as the case may be, shall approve only those related person transactions that are determined to be in, or not inconsistent with, the best interests
of Synta and its stockholders, taking into account all available facts and circumstances as the committee or the chairman determines in good faith to be necessary. These facts and circumstances will
typically include, but not be limited to, the benefits of the transaction to Synta; the impact on a director's independence in the event the related person is a director, an immediate family member of
a director or an entity in which a director is a partner, stockholder or executive officer; the availability of other sources for comparable products or services; the terms of the transaction; and the
terms of comparable transactions that would be available to unrelated third parties or to employees generally. No member of the audit committee shall participate in any review, consideration or
approval of any related person transaction with respect to which the member or any of his or her immediate family members is the related person.
Madrigal Transactions
2015 Bridge Notes
During 2015, Madrigal issued convertible promissory notes in the aggregate principal amount of $2.8 million investment entities
affiliated with Bay City Capital, or the Bay City Funds. The Bay City Funds are the principal stockholders of Madrigal. Fred B. Craves, Ph.D., a director of Madrigal, is a managing director of Bay
City Capital. The table below sets forth the convertible promissory notes with aggregate principal in excess of $120,000 that were purchased in 2015 by Madrigal's directors, executive officers and
holders of more than 5% of its capital stock.
|
|
|
|
|
Name of 2015 Bridge Note Holder
|
|
Outstanding
Principal
Purchased in 2015
|
|
Bay City Capital Fund IV, L.P.
|
|
$
|
2,740,920
|
|
Bay City Capital Fund IV Co-Investment Fund, L.P.
|
|
$
|
59,080
|
|
2015 Working Capital Advances
On June 29, 2015 and July 30, 2015, respectively, Madrigal and Dr. Craves entered into reimbursement agreements,
pursuant to which Dr. Craves agreed to make available up to $500,000 in the aggregate to Madrigal for working capital purposes. All amounts advanced under the agreements accrue interest rate of
4% interest per annum compounded annually.
Madrigal Private Placement in Connection with Merger
In connection with signing of the merger agreement, certain funds associates with Bay City Capital, Madrigal's largest stockholder;
Fred Craves, Ph.D., the founder and a managing director of Bay City
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Table of Contents
Capital,
and an investment entity affiliated with Dr. Taub and Dr. Friedman called SQN, LLC (of which they are the sole members) irrevocably committed to provide Madrigal funding
during the pendency of the merger. This arrangement was made pursuant to an amended and restated senior secured note purchase agreement between the investors and Madrigal dated April 13, 2016.
Specifically, these investors agreed to invest $9 million in the form of convertible promissory notes pursuant to a funding schedule correlating to Madrigal's anticipated clinical
activity/funding needs, with the last scheduled funding date being July 15, 2016. Upon the closing of the merger, the principal amount outstanding of these convertible notes will automatically
convert into shares of the Synta common stock. Assuming the merger closes on or after July 15, 2016, the aggregate principal amount then outstanding would convert into an aggregate of
approximately 46,630,674 shares of Synta common stock. Synta has third-party beneficiary rights with respect to this contractual commitment between the investors and Madrigal,
including the right to enforce, or cause Madrigal to enforce, the obligation of the investors to lend the funds to Madrigal pursuant to the schedule and other terms of the agreement.
The
table below shows the aggregate amount that each lender is committed to loan and the number of shares of Synta common stock that such convertible notes will convert into upon the
closing:
|
|
|
|
|
|
Name of 2016 Bridge Note Lender
|
|
Principal
Amount
Committed
to Fund
|
|
Conversion into
Number of
Synta Shares
|
Bay City Affiliated Funds
|
|
$
|
1,999,875
|
|
10,362,372 shares
|
Fred Craves, Ph.D.
|
|
$
|
1,999,875
|
|
10,362,372 shares
|
SQN, LLC
|
|
$
|
5,000,250
|
|
25,905,930 shares
|
Total
|
|
$
|
9,000,000
|
|
46,630,674 shares
|
On
March 1, 2016 and April 13, 2016, respectively, pursuant to the above arrangement, Madrigal issued convertible notes in the aggregate principal amount of
$3.4 million to certain investors, including the Bay City Funds and an investment entity affiliated with Dr. Taub and Dr. Friedman, SQN, LLC. The table below sets forth the
convertible notes with aggregate principal in excess of $120,000 that were purchased in 2016 by Madrigal's directors, executive officers and holders of more than 5% of its capital stock.
|
|
|
|
|
Name of 2016 Bridge Note Holder
|
|
Outstanding
Principal
Purchased in 2016
|
|
Bay City Capital Fund IV, L.P.
|
|
$
|
734,175
|
|
Bay City Capital Fund IV Co-Investment Fund, L.P.
|
|
$
|
15,825
|
|
SQN, LLC
|
|
$
|
1,875,000
|
|
Fred Craves, Ph.D.(1)
|
|
$
|
750,000
|
|
-
(1)
-
$500,000
of this amount is evidenced by the funds contributed to Madrigal by Dr. Craves pursuant to the reimbursement agreements described above and
deemed contributed by Dr. Craves in exchange for $500,000 in convertible notes as of April 13, 2016. Dr. Craves also contributed $250,000 in cash as of April 13, 2016.
Madrigal Change in Control Bonus Plan
Madrigal has a Change in Control Bonus Plan, or the Madrigal CoC Bonus Plan, pursuant to which certain Madrigal key service providers
will be awarded bonuses in the event there is a change in control, as defined, of Madrigal. The purpose of the Madrigal CoC Bonus Plan is to compensate certain key service providers of Madrigal for
past services, and secure, to a limited extent, their continued services to the company. In accordance with the Madrigal CoC Bonus Plan, up to 10% of the net proceeds will be paid to eligible
participants based upon their participation agreement, which
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Table of Contents
will
be funded out of the consideration actually provided to Madrigal and/or the stockholders of Madrigal in connection with a change of control transaction and will be the same form of consideration
actually transferred. In connection with the merger, it is expected that an aggregate of approximately 19,973,473 shares of Synta common stock to which the following Madrigal securityholders would
otherwise be entitled to receive in connection with the merger will be allocated to certain Madrigal service providers under the Madrigal CoC Bonus Plan, including 14,144,635 shares of Synta common
stock to be allocated to Dr. Taub:
|
|
|
|
|
Name of Madrigal Securityholder Allocating Shares to the Madrigal CoC Bonus Plan
|
|
Number of Shares
of Synta Common
Stock Allocated to
the Madrigal
CoC Bonus Plan
|
|
Bay City Capital Affiliated Funds
|
|
|
19,584,884
|
|
SQN, LLC
|
|
|
388,589
|
|
Total
|
|
|
19,973,473
|
|
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Table of Contents
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
The following information and all other information contained in this proxy statement does not give effect to
the proposed reverse stock split described in Proposal No. 2 of this proxy statement.
The
following unaudited pro forma condensed combined financial statements were prepared using the acquisition method of accounting under existing U.S. generally accepted accounting
principles, or GAAP, and give effect to the merger between Madrigal and Synta. For accounting purposes, Madrigal is considered to be acquiring Synta in the merger. Madrigal was determined to be the
accounting acquirer based upon the terms of the Merger Agreement and other factors including: (i) Madrigal security holders are expected to own approximately 64% of the voting interests of the
combined company immediately following the closing of the merger; (ii) directors appointed by Madrigal will hold
a majority of board seats in the combined company; and (iii) Madrigal management will hold a majority of the key positions in the management of the combined company.
The
unaudited pro forma condensed combined balance sheet as of March 31, 2016 assumes that the merger took place on March 31, 2016 and combines the historical balance
sheets of Synta and Madrigal as of March 31, 2016. The unaudited pro forma condensed combined statement of operations for the three months ended March 31, 2016 assumes that the merger
took place as of January 1, 2016, and combines the historical results of Synta and Madrigal for the three months ended March 31, 2016. The unaudited pro forma condensed combined
statement of operations for the year ended December 31, 2015 assumes that the merger took place as of January 1, 2015, and combines the historical results of Synta and Madrigal for the
year ended December 31, 2015. The historical financial statements of Synta and Madrigal have been adjusted to give pro forma effect to events that are (i) directly attributable to the
merger, (ii) factually supportable, and (iii) with respect to the statements of operations, expected to have a continuing impact on the combined results.
Because
Madrigal will be treated as the accounting acquirer, Madrigal's assets and liabilities will be recorded at their precombination carrying amounts and the historical operations
that are reflected in the financial statements will be those of Madrigal. Synta's assets and liabilities will be measured and recognized at their fair values as of the transaction date, and
consolidated with the assets, liabilities and results of operations of Madrigal after the consummation of the merger.
The
unaudited pro forma condensed combined financial statements are based on the assumptions and adjustments that are described in the accompanying notes. The application of the
acquisition method of accounting is dependent upon certain valuations and other studies that have yet to be completed. Accordingly, the pro forma adjustments are preliminary, subject to further
revision as additional information becomes available and additional analyses are performed, and have been made solely for the purpose of providing unaudited pro forma condensed combined financial
statements. Differences between these preliminary estimates and the final acquisition accounting, expected to be completed after the closing of the merger, will occur and these differences could have
a material impact on the accompanying unaudited pro forma condensed combined financial statements and the combined company's future results of operations and financial position. The actual amounts
recorded as of the completion of the merger may differ materially from the information presented in these unaudited pro forma condensed combined financial statements as a result of the amount, if any,
of capital raised by Madrigal between entering the Merger Agreement and closing of the merger; the amount of cash used by Synta's operations between the signing of the Merger Agreement and the closing
of the merger; the timing of closing of the merger; Synta's stock price at the closing of the merger; the results of certain valuations and other studies that have yet to be completed; and other
changes in Synta's assets and liabilities that occur prior to the completion of the merger.
The
unaudited pro forma condensed combined financial statements do not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or
other savings or expenses that may be associated with the integration of the two companies. The unaudited
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Table of Contents
pro
forma condensed combined financial statements have been prepared for illustrative purposes only and are not necessarily indicative of the financial position or results of operations in future
periods or the results that actually would have been realized had Madrigal and Synta been a combined company during the specified period.
The
unaudited pro forma condensed combined financial statements, including the notes thereto, should be read in conjunction with the separate Madrigal and Synta historical financial
statements, and their respective management's discussion and analysis of financial condition and results of operations. Madrigal's historical unaudited financial statements for three months ended
March 31, 2016 and historical audited financial statements for the year ended December 31, 2015 are included elsewhere in this proxy statement. Synta's historical unaudited condensed
consolidated financial statements for the three months ended March 31, 2016 are included in its Quarterly Report on Form 10-Q as filed with the SEC on May 10, 2016 and its
historical audited consolidated financial statements for the year ended December 31, 2015 are included in its Annual Report on Form 10-K as filed with the SEC on March 15, 2016.
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Table of Contents
Unaudited Pro Forma Condensed Combined Balance Sheet
March 31, 2016
(
in thousands
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synta
Pharmaceuticals
Corp.
|
|
Madrigal
Pharmaceuticals
Corp.
|
|
Pro Forma
Merger
Adjustment
|
|
|
|
Pro Forma
Combined
|
|
Assets
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
42,815
|
|
$
|
618
|
|
|
7,750
|
|
A
|
|
|
51,183
|
|
Marketable securities
|
|
|
9,227
|
|
|
|
|
|
|
|
|
|
|
9,227
|
|
Prepaid expenses and other current assets
|
|
|
554
|
|
|
152
|
|
|
|
|
|
|
|
706
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
52,596
|
|
|
770
|
|
|
7,750
|
|
|
|
|
61,116
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
374
|
|
|
|
|
|
|
|
|
|
|
374
|
|
Goodwill
|
|
|
|
|
|
|
|
|
17,671
|
|
F
|
|
|
17,671
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
52,970
|
|
$
|
770
|
|
|
25,421
|
|
|
|
$
|
79,161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity (Deficit) Current liabilities
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
744
|
|
|
470
|
|
|
|
|
|
|
|
1,214
|
|
Accrued contract research costs
|
|
|
2,737
|
|
|
|
|
|
|
|
|
|
|
2,737
|
|
Other accrued liabilities
|
|
|
2,826
|
|
|
97
|
|
|
6,328
|
|
D
|
|
|
9,251
|
|
Capital lease obligations
|
|
|
33
|
|
|
|
|
|
|
|
|
|
|
33
|
|
Term loans
|
|
|
2,299
|
|
|
|
|
|
|
|
|
|
|
2,299
|
|
Convertible promissory notes payablerelated party
|
|
|
|
|
|
50,315
|
|
|
8,250
|
|
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,429
|
)
|
B
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(45,136
|
)
|
B
|
|
|
|
|
Advances payable-related party
|
|
|
|
|
|
514
|
|
|
(500
|
)
|
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14
|
)
|
B
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
8,639
|
|
|
51,396
|
|
|
(44,501
|
)
|
|
|
|
15,534
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
8,639
|
|
|
51,396
|
|
|
(44,501
|
)
|
|
|
|
15,534
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity (deficit)
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
14
|
|
|
|
|
|
4
|
|
B
|
|
|
40
|
|
|
|
|
|
|
|
|
|
|
3
|
|
C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14
|
)
|
E
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33
|
|
F
|
|
|
|
|
Additional paid-in capital
|
|
|
757,081
|
|
|
6
|
|
|
45,132
|
|
B
|
|
|
114,405
|
|
|
|
|
|
|
|
|
|
|
12,282
|
|
C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750
|
|
D
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(759,364
|
)
|
E
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,518
|
|
F
|
|
|
|
|
Accumulated other comprehensive income
|
|
|
4
|
|
|
|
|
|
(4
|
)
|
E
|
|
|
|
|
Accumulated deficit
|
|
|
(712,768
|
)
|
|
(50,632
|
)
|
|
13,443
|
|
B
|
|
|
(50,818
|
)
|
|
|
|
|
|
|
|
|
|
(12,285
|
)
|
C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,078
|
)
|
D
|
|
|
|
|
|
|
|
|
|
|
|
|
|
718,502
|
|
E
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders' equity (deficit)
|
|
|
44,331
|
|
|
(50,626
|
)
|
|
69,922
|
|
|
|
|
63,627
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity (deficit)
|
|
$
|
52,970
|
|
|
770
|
|
|
25,421
|
|
|
|
$
|
79,161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
229
Table of Contents
Unaudited Pro Forma Condensed Combined Statement of Operations
For the Three Months Ended March 31, 2016
(
in thousands, except share and per share data
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synta
Pharmaceuticals
Corp.
|
|
Madrigal
Pharmaceuticals
Corp.
|
|
Pro Forma
Merger
Adjustment
|
|
|
|
Pro Forma
Combined
|
|
Revenues:
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
3,407
|
|
$
|
516
|
|
|
214
|
|
G
|
|
|
4,137
|
|
General and administrative
|
|
|
3,040
|
|
|
222
|
|
|
(32
|
)
|
G, H
|
|
|
3,230
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
6,447
|
|
|
738
|
|
|
182
|
|
|
|
|
7,367
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(6,447
|
)
|
|
(738
|
)
|
|
(182
|
)
|
|
|
|
(7,367
|
)
|
Interest expense, net
|
|
|
(77
|
)
|
|
(975
|
)
|
|
975
|
|
I
|
|
|
(77
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,524
|
)
|
$
|
(1,713
|
)
|
$
|
793
|
|
|
|
$
|
(7,444
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$
|
(0.05
|
)
|
$
|
(1.55
|
)
|
|
|
|
|
|
$
|
(0.02
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of common shares outstanding
|
|
|
137,362,260
|
|
|
1,105,820
|
|
|
258,167,903
|
|
J, K
|
|
|
396,575,163
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Pro Forma Condensed Combined Statement of Operations
For the Year Ended December 31, 2015
(
in thousands, except share and per share data
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synta
Pharmaceuticals
Corp.
|
|
Madrigal
Pharmaceuticals
Corp.
|
|
Pro Forma
Merger
Adjustment
|
|
|
|
Pro Forma
Combined
|
|
Revenues:
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
54,218
|
|
$
|
2,427
|
|
|
856
|
|
G
|
|
|
57,501
|
|
General and administrative
|
|
|
13,392
|
|
|
806
|
|
|
1,760
|
|
G, H
|
|
|
15,958
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
67,610
|
|
|
3,233
|
|
|
2,616
|
|
|
|
|
73,459
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(67,610
|
)
|
|
(3,233
|
)
|
|
(2,616
|
)
|
|
|
|
(73,459
|
)
|
Interest expense, net
|
|
|
(1,061
|
)
|
|
(3,612
|
)
|
|
3,612
|
|
I
|
|
|
(1,061
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(68,671
|
)
|
$
|
(6,845
|
)
|
$
|
996
|
|
|
|
$
|
(74,520
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$
|
(0.53
|
)
|
$
|
(6.38
|
)
|
|
|
|
|
|
$
|
(0.19
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of common shares outstanding
|
|
|
128,594,835
|
|
|
1,073,351
|
|
|
258,184,823
|
|
J, K
|
|
|
387,824,658
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
230
Table of Contents
NOTES TO THE UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
1. Description of Transaction and Basis of Presentation
The unaudited pro forma condensed combined financial statements were prepared in accordance with GAAP and pursuant to the rules and regulations of SEC
Regulation S-X, and present the pro forma financial position and results of operations of the combined companies based upon the historical data of Synta and Madrigal.
Description of Transaction
On April 13, 2016, Synta and Madrigal entered into an Agreement and Plan of Merger and Reorganization pursuant to which Saffron
Merger Sub Inc., a wholly owned subsidiary of Synta, will merge with and into Madrigal, with Madrigal surviving as a wholly owned subsidiary of Synta (the merger). Following the completion of
the merger, Synta will be renamed Madrigal Pharmaceuticals, Inc. Under the terms of the merger, Synta will acquire all outstanding shares of common stock of Madrigal in exchange for
approximately 253.9 million newly issued shares of Synta's common stock. Immediately following the closing of the merger, the stockholders of Synta will own approximately 36% of the voting
interests of the combined company and the former Madrigal stockholders will own approximately 64% of the voting interests of the combined company. The merger is expected to close in the third quarter
of 2016, subject to customary closing conditions, including the approval of the merger by Synta's stockholders, Synta having a minimum net cash amount of $28.5 million, Madrigal raising an
aggregate of $9.0 million in the form of convertible promissory notes, and Madrigal's extinguishment of all convertible promissory notes, including the conversion of the principal portion to
shares of common stock of Madrigal and the waiver of the corresponding accrued interest.
On
April 13, 2016, Madrigal entered into contingent employment agreements ("Letter Agreements") with Paul A. Friedman, M. D. for the position of Chairman and Chief Executive
Officer ("CEO") and with Rebecca Taub, M. D., Madrigals's founder and current Chief Executive Officer, for the position of Chief Medical Officer and Executive Vice President Research &
Development ("CMO"). These employment agreements are contingent on the closing of the merger. Under the terms of the Letter Agreement for the CEO position, Dr. Friedman will receive an annual
base salary of $400,000, an annual performance-based bonus of up to 50% of his base salary, and equity awards based upon the issued and outstanding shares of common stock of the combined company,
including 4,958,556 shares of restricted common stock and 9,917,113 stock options to purchase shares of common stock. Under the terms of the Letter Agreement for the CMO position, Dr. Taub will
receive an annual base salary of $370,000, an annual performance-based bonus of up to 40% of her base salary and equity awards based upon the issued and outstanding shares of common stock of the
combined company, including 991,711 shares of restricted common stock and 4,958,556 stock options to purchase shares of common stock. The repurchase right relating to these shares of restricted stock
will lapse as to 25% of the shares on the business day immediately following the closing of the merger and the repurchase right on the remaining shares will lapse annually on the first, second and
third anniversaries of the date of the merger. The stock options will vest as to 25% of the shares on the business day immediately following
the closing of the merger and then annually on the first, second and third anniversaries of the date of the merger.
Basis of Presentation
Madrigal has preliminarily concluded that the merger represents a business combination pursuant to Financial Accounting Standards Board
Accounting Standards Codification Topic 805,
Business Combinations
. Madrigal has not yet completed a valuation analysis of the fair market value of
Synta's
231
Table of Contents
assets
to be acquired and liabilities to be assumed. Using the total consideration for the merger, Madrigal has estimated the allocations to such assets and liabilities. This preliminary purchase
price allocation has been used to prepare pro forma adjustments in the unaudited pro forma condensed combined balance sheet. The final purchase price allocation will be determined when Madrigal has
completed the detailed valuations and other studies and necessary calculations. The final allocation could differ materially from the preliminary allocation used to prepare the pro forma adjustments.
The final allocation may include (1) changes in fair values of property and equipment, (2) changes in allocations to intangible assets and goodwill based on the results of certain
valuations and other studies that have yet to be completed and (3) other changes to assets and liabilities.
Madrigal
and Synta did not record any provision or benefit for income taxes during the three months ended March 31, 2016 or during the year ended December 31, 2015 because
each company expects to incur a pre-tax loss in 2016 and incurred a pre-tax loss in 2015 and each company maintains a full valuation allowance on its deferred tax assets. Accordingly, no tax effects
have been provided for the pro forma adjustments described in Note 3, "Pro Forma Adjustments."
Treatment of Stock Options, Restricted Stock and Restricted Stock Units in the Merger
Prior to the closing of the merger, Madrigal does not have any outstanding stock options.
Synta
equity awards issued and outstanding at the time of the merger will remain issued and outstanding. For accounting purposes, Synta equity awards will be assumed to have been
exchanged for equity awards of Madrigal, the accounting acquirer. As of March 31, 2016, Synta had 409,786 shares of unvested restricted common stock, 5,000,000 unvested restricted stock units,
and 7,335,500 outstanding stock options to purchase shares of common stock, of which 3,895,204 stock options were exercisable at a weighted average exercise price per option of $5.68. The portion of
the acquisition-date fair value of the Synta equity awards, including restricted common stock and restricted stock units, that is attributable to precombination service to Synta will be treated as a
component of the purchase price. All of Synta's stock options have an exercise price in excess of the closing price of Synta's common stock on May 2, 2016, the most recent practicable date, and
the basis for estimating the preliminary purchase price for purposes of the unaudited pro forma condensed combined financial statements. As a result, the acquisition date fair value of Synta's stock
option awards is not significant to the determination of the purchase price. See Note 2, "Preliminary Purchase Price."
Madrigal Change in Control Bonus Plan
Madrigal has a Change in Control Bonus Plan, or the Madrigal CoC Bonus Plan, pursuant to which certain Madrigal key service providers
will be awarded bonuses in the event there is a change in control, as defined, of Madrigal. The merger between Madrigal and Synta meets this definition of a change in control. The purpose of the
Madrigal CoC Bonus Plan is to compensate certain key service providers of Madrigal for past services, and secure, to a limited extent, their continued services to the company. In accordance with the
Madrigal CoC Bonus Plan, up to 10% of the net proceeds will be paid to eligible participants based upon their participation agreement, which will be funded out of the consideration actually provided
to Madrigal and/or the stockholders of Madrigal in connection with a change of control transaction and will be the same form of consideration actually transferred. In connection with the merger, it is
expected that an aggregate of approximately 19,973,473 shares of Synta common stock to which certain Madrigal securityholders would otherwise be entitled to receive in connection with the merger will
be allocated to certain Madrigal service providers under the Madrigal CoC Bonus Plan, including 14,144,635 shares of Synta common stock to be allocated to Dr. Taub.
232
Table of Contents
2. Preliminary Purchase Price
Pursuant to the Merger Agreement, at the closing of the merger, Synta will issue to Madrigal stockholders a number of shares of Synta common stock representing
approximately 64% of the outstanding shares of common stock of the combined company. The estimated preliminary purchase price, which represents the consideration transferred to Synta stockholders in
the reverse merger is calculated based on the number of shares of common stock of the combined company that Synta stockholders will own as of the closing of the merger. The accompanying unaudited pro
forma condensed combined financial statements reflect an estimated purchase price of approximately $58.6 million, which consists of the following:
|
|
|
|
|
|
|
(in thousands,
except share
and per share
amounts)
|
|
Estimated number of shares of the combined company to be owned by Synta stockholders(1)
|
|
|
142,806,441
|
|
Multiplied by the assumed price per share of Synta common stock(2)
|
|
$
|
0.41
|
|
|
|
|
|
|
Estimated purchase price
|
|
$
|
58,551
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
(1)
-
Represents
the number of shares of common stock of the combined company that Synta stockholders would own as of the closing of the merger pursuant to the
Merger Agreement, including restricted stock awards and common stock underlying outstanding restricted stock units attributed to precombination services rendered by certain Synta employees and
directors. This amount is calculated, for purposes of these unaudited pro forma condensed combined financial statements, as 137,806,441 shares of Synta common stock outstanding as of March 31,
2016, including 409,786 shares of unvested restricted common stock, plus 5,000,000 shares of Synta common stock issuable pursuant to restricted stock units that would vest immediately upon closing of
the merger.
The
number of shares of common stock Synta will issue to Madrigal stockholders, for purposes of these unaudited pro forma condensed combined financial statements, is calculated pursuant to the terms
of the Merger Agreement based on Synta's common stock outstanding as of March 31, 2016, as follows:
|
|
|
|
|
Shares of Synta common stock outstanding as of March 31, 2016
|
|
|
137,806,441
|
|
Shares of Synta common stock subject to outstanding Synta restricted stock units
|
|
|
5,000,000
|
|
|
|
|
|
|
Adjusted outstanding shares of Synta common stock
|
|
|
142,806,441
|
|
Divided by the assumed percentage of Synta ownership of combined company
|
|
|
36
|
%
|
Estimated adjusted total shares of common stock of combined company
|
|
|
396,684,558
|
|
Multiplied by the assumed percentage of Madrigal ownership of combined company
|
|
|
64
|
%
|
Estimated shares of Synta common stock issued to Madrigal upon closing of merger
|
|
|
253,878,117
|
|
-
(2)
-
For
pro forma purposes, the fair value of Synta common stock used in determining the purchase price was $0.41 per share based on the closing price of Synta
common stock on May 2, 2016, the most recent practicable date. The pro forma information is illustrative only and the total purchase price at closing of the merger will be adjusted based upon
the actual closing price of the common stock of Synta. A $0.01 increase (decrease) in the per share stock price would increase (decrease) the total purchase price by approximately $1.4 million.
233
Table of Contents
Under
the acquisition method of accounting, the total purchase price is allocated to the acquired tangible and intangible assets and assumed liabilities of Synta based on their estimated
fair values as of the merger closing date. The excess of the purchase price over the fair value of assets acquired and liabilities assumed, if any, is allocated to goodwill.
The
allocation of the total preliminary estimated purchase price to the acquired assets and liabilities assumed of Synta based on the estimated fair values as of March 31, 2016 is
as follows (in thousands):
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
52,042
|
|
Prepaid expenses and other currents assets
|
|
|
554
|
|
Property and equipment, net
|
|
|
374
|
|
Goodwill
|
|
|
17,671
|
|
Accounts payable, accrued expenses and other liabilities
|
|
|
(9,758
|
)
|
Term loans and capital lease obligations
|
|
|
(2,332
|
)
|
|
|
|
|
|
Net assets acquired
|
|
$
|
58,551
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
application of the acquisition method of accounting is dependent upon certain valuations and other studies that have yet to be completed. The purchase price allocation will remain
preliminary until Madrigal management determines the fair values of assets acquired and liabilities assumed. The final determination of the purchase price allocation is anticipated to be completed as
soon as practicable after completion of the merger and will be based on the fair values of the assets acquired and liabilities assumed as of the merger closing date. The final amounts allocated to
assets acquired and liabilities assumed could differ significantly from the amounts presented in the unaudited pro forma condensed combined financial statements. The final allocation may include
(1) changes in fair values of property and equipment, (2) changes in allocations to intangible assets and goodwill based on the results of certain valuations and other studies that have
yet to be completed and (3) other changes to assets and liabilities.
-
3.
-
Pro Forma Adjustments
The
unaudited pro forma condensed combined financial statements include pro forma adjustments that are (i) directly attributable to the merger, (ii) factually supportable,
and (iii) with respect to the unaudited pro forma condensed combined statements of operations, expected to have a continuing impact on the results of operations of the combined company.
Based
on Madrigal management's review of Synta's summary of significant accounting policies, the nature and amount of any adjustments to the historical financial statements of Synta to
conform to the accounting policies of Madrigal are not expected to be significant.
The
unaudited pro forma condensed combined financial statements do not reflect the effect of the anticipated Synta reverse stock split.
The
pro forma adjustments, based on preliminary estimates that may change significantly as additional information is obtained, are as follows:
-
A
-
To
reflect Madrigal's issuance of $9.0 million of convertible promissory notes prior to the closing of the merger, as required pursuant to the Merger
Agreement. The remaining net proceeds are approximately $7.8 million, reflective of the approximate $0.7 million issuance of convertible promissory notes on March 1, 2016 and the
conversion of $0.5 million in related party advances payable into convertible promissory notes on April 13, 2016.
-
B
-
To
reflect the conversion of the principal portion of Madrigal's convertible promissory notes of approximately $45.1 million to Madrigal common stock
and the extinguishment of the
234
Table of Contents
235
Table of Contents
DESCRIPTION OF SYNTA CAPITAL STOCK
Description of Common Stock
Synta is authorized to issue 200,000,000 shares of common stock, par value $0.0001 per share. As of May 31, 2016, we had
137,806,441 shares of common stock outstanding and approximately 39 stockholders of record.
The
following summary of certain provisions of our common stock does not purport to be complete. You should refer to our restated certificate of incorporation and our restated bylaws,
both of which have been filed with the Securities and Exchange Commission. The summary below is also qualified by provisions of applicable law.
General
Holders of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the stockholders,
and do not have cumulative voting rights. Subject to preferences that may be applicable to any outstanding shares of preferred stock, holders of common stock are entitled to receive ratably such
dividends, if any, as may be declared from time to time by our board of directors out of funds legally available for dividend payments. The holders of common stock have no preferences or rights of
conversion, exchange, pre-emption or other subscription rights. There are no redemption or sinking fund provisions applicable to the common stock. In the event of any liquidation, dissolution or
winding-up of our affairs, holders of common stock will be entitled to share ratably in our assets that are remaining after payment or provision for payment of all of our debts and obligations and
after liquidation payments to holders of outstanding shares of preferred stock, if any.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Computershare Trust Company, N.A.
NASDAQ Capital Market
Our common stock is listed for quotation on The NASDAQ Capital Market under the symbol "SNTA."
Description of Preferred Stock
We are authorized to issue 5,000,000 shares of preferred stock, par value $0.0001 per share. As of May 31, 2016, no shares of
our preferred stock were outstanding or designated. The following summary of certain provisions of our preferred stock does not purport to be complete. You should refer to our restated certificate of
incorporation and our restated bylaws, both of which have been filed with the Securities and Exchange Commission. The summary below is also qualified by provisions of applicable law.
General
Our board of directors may, without further action by our stockholders, from time to time, direct the issuance of shares of preferred
stock in series and may, at the time of issuance, determine the rights, preferences and limitations of each series, including voting rights, dividend rights and redemption and liquidation preferences.
Satisfaction of any dividend preferences of outstanding shares of preferred stock would reduce the amount of funds available for the payment of dividends on shares of our common stock. Holders of
shares of preferred stock may be entitled to receive a preference payment in the event of any liquidation, dissolution or winding-up of our company before any payment is made to the holders of shares
of our common stock. In some circumstances, the issuance of shares of preferred stock may render more difficult or tend to discourage a merger, tender offer or proxy
236
Table of Contents
contest,
the assumption of control by a holder of a large block of our securities or the removal of incumbent management. Upon the affirmative vote of our board of directors, without stockholder
approval, we may issue shares of preferred stock with voting and conversion rights which could adversely affect the holders of shares of our common stock.
Anti-Takeover Provisions of our Certificate of Incorporation and Bylaws
In addition to the board of directors' ability to issue shares of preferred stock, our restated certificate of incorporation and
restated bylaws contain other provisions that are intended to enhance the likelihood of continuity and stability in the composition of the board of directors and which may have the effect of delaying,
deferring or preventing a future takeover or change in control of our company unless such takeover or change in control is approved by our board of directors.
These
provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking
to acquire control of us to first negotiate with our board of directors. We believe that the benefits of increased protection of our potential ability to negotiate with the proponent of an unfriendly
or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.
Classified board of directors; removal of directors for cause.
Our restated certificate of incorporation and restated bylaws provide for
our board of
directors to be divided into three classes serving staggered terms. At each annual meeting of stockholders, directors elected to succeed those directors whose terms expire are elected for a three-year
term of office. All directors elected to our classified board of directors will serve until the election and qualification of their respective successors or their earlier resignation or removal. The
board of directors is authorized to create new directorships and to fill such positions so created and is permitted to specify the class to which any such new position is assigned. The person filling
such position would serve for the term applicable to that class. The board of directors (or its remaining members, even if less than a quorum) is also empowered to fill vacancies on the board of
directors occurring for any reason for the remainder of the term of the class of directors in which the vacancy occurred. Members of the board of directors may only be removed for cause and only by
the affirmative vote of 80% of our outstanding voting stock. These provisions are likely to increase the time required for stockholders to change the composition of the board of directors. For
example, in general, at least two annual meetings will be necessary for stockholders to effect a change in a majority of the members of the board of directors. The provision for a classified board
could prevent a party who acquires control of a majority of our outstanding common stock from obtaining control of our board of directors until our second annual stockholders meeting following the
date the acquirer obtains the controlling stock interest. The classified board provision could have the effect of discouraging a potential acquirer from making a tender offer or otherwise attempting
to obtain control of us and could increase the likelihood that incumbent directors will retain their positions.
Advance notice provisions for stockholder proposals.
Our restated bylaws establish an advance notice procedure for stockholder
proposals to be
brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors, as well as procedures for including proposed nominations at
special meetings at which directors are to be elected. Stockholders at our annual meeting may only consider proposals or nominations specified in the notice of meeting or brought before the meeting by
or at the direction of our board or by a stockholder who was a stockholder of record on the record date for the meeting, who is entitled to vote at the meeting and who has given to our secretary
timely written notice, in proper form, of the stockholder's intention to bring that business before the meeting, and who has complied with the procedures and requirements set forth in the bylaws.
Although our bylaws do not give our board of directors the power to approve or disapprove stockholder nominations of candidates or proposals
237
Table of Contents
regarding
other business to be conducted at a special or annual meeting, our bylaws may have the effect of precluding the conduct of some business at a meeting if the proper procedures are not
followed or may discourage or defer a potential acquirer from conducting a solicitation of proxies to elect its own slate of directors or otherwise attempting to obtain control of us.
Special meetings of stockholders.
Special meetings of the stockholders may be called only by our board of directors pursuant to a
resolution adopted
by a majority of the total number of authorized directors. Stockholders are not permitted to call a special meeting or to require our board of directors to call a special meeting.
No stockholder action by written consent.
Our restated certificate of incorporation and restated bylaws do not permit our stockholders
to act by
written consent. As a result, any action to be effected by our stockholders must be effected at a duly called annual or special meeting of the stockholders.
Super-majority stockholder vote required for certain actions.
The DGCL provides generally that the affirmative vote of a majority of
the shares
entitled to vote on any matter is required to amend a corporation's certificate of incorporation or bylaws, unless the corporation's certificate of incorporation or bylaws, as the case may be,
requires a greater percentage. Our restated certificate of incorporation requires the affirmative vote of the holders of at least 80% of our outstanding voting stock to amend or repeal certain
provisions of our restated certificate of incorporation. This 80% stockholder vote would be in addition to any separate class vote that might in the future be required pursuant to the terms of any
preferred stock that might then be outstanding. In addition, an 80% vote is also required for any
amendment to, or repeal of, our restated bylaws by the stockholders. Our restated bylaws may be amended or repealed by a vote of a majority of the total number of authorized directors.
Provisions of Delaware Law Governing Business Combinations
We are subject to the "business combination" provisions of Section 203 of the DGCL. In general, such provisions prohibit a
publicly held Delaware corporation from engaging in any "business combination" transactions with any "interested stockholder" for a period of three years after the date on which the person became an
"interested stockholder," unless:
-
-
prior to such date, the board of directors approved either the "business combination" or the transaction which resulted in the
"interested stockholder" obtaining such status; or
-
-
upon consummation of the transaction which resulted in the stockholder becoming an "interested stockholder," the "interested
stockholder" owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding (but not
the outstanding voting stock owned by the "interested stockholder") those shares owned by (a) persons who are directors and also officers and (b) employee stock plans in which employee
participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
-
-
at or subsequent to such time the "business combination" is approved by the board of directors and authorized at an annual or special
meeting of stockholders, and not by written consent, by the affirmative vote of at least 66
2
/
3
% of the outstanding voting stock which is not owned by the "interested stockholder."
A
"business combination" is defined to include mergers, asset sales and other transactions resulting in financial benefit to a stockholder. In general, an "interested stockholder" is a
person who, together
with affiliates and associates, owns 15% or more of a corporation's voting stock or within three years did own 15% or more of a corporation's voting stock. The statute could prohibit or delay mergers
or other takeover or change in control attempts with respect to us and, accordingly, may discourage attempts to acquire us.
238
Table of Contents
Stockholder Proposals
To be considered for inclusion in the proxy statement relating to our 2017 Annual Meeting of Stockholders, we must receive stockholder
proposals no later than February 13, 2017. To be considered for presentation at the 2017 Annual Meeting, although not included in the proxy statement, proposals must be received no earlier than
March 30, 2017 and no later than April 29, 2017; provided, however, that in the event that the date of the 2017 Annual Meeting is more than thirty (30) days before or more than
thirty (30) days after the anniversary date of the preceding year's Annual Meeting, notice by the stockholder to be timely must be so delivered not earlier than the close of business on the
ninetieth (90th) day prior to such Annual Meeting and not later than the close of business on the later of the sixtieth (60th) day prior to such Annual Meeting or the tenth (10th) day following the
day on which we make a public announcement of the date of such meeting.
Proposals
that are not received in a timely manner will not be voted on at the 2017 Annual Meeting. If a proposal is received on time, the proxies that management solicits for the
meeting may still exercise discretionary voting authority on the proposal under circumstances consistent with the proxy rules of
the SEC. All stockholder proposals should be marked for the attention of Secretary, Synta Pharmaceuticals Corp., 125 Hartwell Avenue, Lexington, MA 02421.
WHERE YOU CAN FIND MORE INFORMATION
Synta files annual, quarterly and special reports, proxy statements and other information with the SEC. You may read and copy any
reports, statements or other information that Synta files at the SEC public reference room in at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further
information on the public reference rooms. Synta SEC filings are also available to the public from commercial document retrieval services and on the website maintained by the SEC at
http://www.sec.gov.
Synta
has supplied all information contained in this proxy statement relating to Synta, and Madrigal has supplied all information contained in this proxy statement relating to Madrigal.
In
addition, the SEC allows Synta to disclose important information to you by referring you to other documents filed separately with the SEC. This information is considered to be a part
of this proxy statement, except for any information that is superseded by information included directly in this proxy statement or incorporated by reference subsequent to the date of this proxy
statement as described below.
This
proxy statement incorporates by reference the documents listed below that Synta has previously filed with the SEC (other than, in each case, documents or information deemed to have
been furnished and not filed in accordance with SEC rules). They contain important information about Synta and its financial condition.
247
Table of Contents
To
the extent that any information contained in any report on Form 8-K, or any exhibit thereto, was furnished to, rather than filed with, the SEC by the Company, such information
or exhibit is specifically not incorporated by reference.
In
addition, Synta incorporates by reference any future filings it may make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this proxy
statement and before the date of the Annual Meeting (excluding any current reports on Form 8-K to the extent disclosure is furnished and not filed). Those documents are considered to be a part
of this proxy statement, effective as of the date they are filed. In the event of conflicting information in these documents, the information in the latest filed document should be considered correct.
If
you would like to request documents from Synta or Madrigal, please send a request in writing or by telephone to either Synta or Madrigal at the following addresses:
|
|
|
Synta Pharmaceuticals Corp.
|
|
Madrigal Pharmaceuticals, Inc.
|
125 Hartwell Avenue
|
|
500 Office Center Drive, Suite 400
|
Lexington, MA 02421
|
|
Fort Washington, PA 19034
|
Attn: Chief Financial Officer
|
|
Attn: Chief Executive Officer
|
TRADEMARK NOTICE
Synta®, Synta Pharmaceuticals and the GALAXY trial are trademarks of Synta Pharmaceuticals Corp. in the United States and
other jurisdictions. "Madrigal," the Madrigal logo and other trademarks, service marks, and trade names of Madrigal are registered and unregistered marks of Madrigal Pharmaceuticals, Inc. Other
third-party logos and product/trade names are registered trademarks or trade names of their respective companies.
248
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and
Stockholders of Madrigal Pharmaceuticals, Inc.
We
have audited the accompanying balance sheets of Madrigal Pharmaceuticals, Inc. (the "Company") as of December 31, 2015 and 2014, and the related statements of
operations, changes in stockholders' deficit, and cash flows for the years then ended. The Company's management is responsible for these financial statements. Our responsibility is to express an
opinion on these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to
obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances,
but not for the purpose of expressing an opinion on the effectiveness of the company's internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In
our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2015 and 2014, and
the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As described in Note 2 to the financial statements, the
Company has sustained recurring losses from operations, has not yet generated any revenues, and has a working capital deficiency of approximately $48,913,000 at December 31, 2015. These
conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans regarding these matters are also described in Note 2. The financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
/s/
Friedman LLP
East
Hanover, NJ
April 12, 2016
F-2
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Balance Sheets
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2015
|
|
2014
|
|
Assets
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
Cash
|
|
$
|
306,249
|
|
$
|
148,066
|
|
Other receivablerelated party
|
|
|
7,332
|
|
|
46,155
|
|
Prepaid expense
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
363,581
|
|
|
194,221
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
363,581
|
|
$
|
194,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Deficit
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
Convertible promissory notes payablerelated party
|
|
$
|
48,595,166
|
|
$
|
|
|
Advances payablerelated party
|
|
|
500,000
|
|
|
|
|
Accrued interestrelated party
|
|
|
9,278
|
|
|
|
|
Accounts payable
|
|
|
102,293
|
|
|
15,210
|
|
Accrued expenses
|
|
|
70,203
|
|
|
55,000
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
49,276,940
|
|
|
70,210
|
|
Convertible promissory notes payablerelated party
|
|
|
|
|
|
42,192,513
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
49,276,940
|
|
|
42,262,723
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
Stockholders' deficit
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 30,000,000 shares authorized, 0 shares issued and outstanding
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 35,000,000 shares authorized, 1,105,820 and 1,045,000 shares, respectively, issued and outstanding
|
|
|
111
|
|
|
105
|
|
Additional paid-in capital
|
|
|
6,120
|
|
|
6,120
|
|
Accumulated deficit
|
|
|
(48,919,590
|
)
|
|
(42,074,727
|
)
|
|
|
|
|
|
|
|
|
Total stockholders' deficit
|
|
|
(48,913,359
|
)
|
|
(42,068,502
|
)
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' deficit
|
|
$
|
363,581
|
|
$
|
194,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements
F-3
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Statements of Operations
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2015
|
|
2014
|
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
2,427,170
|
|
$
|
777,371
|
|
General and administrative
|
|
|
805,762
|
|
|
548,321
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,232,932
|
)
|
|
(1,325,692
|
)
|
|
|
|
|
|
|
|
|
Other income (expenses)
|
|
|
|
|
|
|
|
Other income
|
|
|
|
|
|
1,704
|
|
Interest expense
|
|
|
(3,611,931
|
)
|
|
(3,167,952
|
)
|
|
|
|
|
|
|
|
|
|
|
|
(3,611,931
|
)
|
|
(3,166,248
|
)
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,844,863
|
)
|
$
|
(4,491,940
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements
F-4
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Statements of Changes in Stockholders' Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
Number of
Shares
|
|
Amount
|
|
Additional
Paid-in Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Deficit
|
|
Balance at January 1, 2014
|
|
|
1,045,000
|
|
$
|
105
|
|
$
|
6,120
|
|
$
|
(37,582,787
|
)
|
$
|
(37,576,562
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
(4,491,940
|
)
|
|
(4,491,940
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2014
|
|
|
1,045,000
|
|
|
105
|
|
|
6,120
|
|
|
(42,074,727
|
)
|
|
(42,068,502
|
)
|
Issuance of restricted stock
|
|
|
60,820
|
|
|
6
|
|
|
|
|
|
|
|
|
6
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
(6,844,863
|
)
|
|
(6,844,863
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2015
|
|
|
1,105,820
|
|
$
|
111
|
|
$
|
6,120
|
|
$
|
(48,919,590
|
)
|
$
|
(48,913,359
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements
F-5
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2015
|
|
2014
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,844,863
|
)
|
$
|
(4,491,940
|
)
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
|
|
|
2,582
|
|
PIK interest expense on convertible promissory notes payablerelated party
|
|
|
3,602,653
|
|
|
3,167,952
|
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
Other receivablerelated party
|
|
|
38,823
|
|
|
(40,156
|
)
|
Prepaid expenses
|
|
|
(50,000
|
)
|
|
|
|
Accounts payable
|
|
|
87,083
|
|
|
(49,082
|
)
|
Accrued expenses
|
|
|
15,203
|
|
|
13,160
|
|
Accrued interestrelated party
|
|
|
9,278
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
3,703,040
|
|
|
3,094,456
|
|
|
|
|
|
|
|
|
|
Net cash used in operations
|
|
|
(3,141,823
|
)
|
|
(1,397,484
|
)
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
Proceeds from convertible notesrelated party
|
|
|
2,800,000
|
|
|
1,375,000
|
|
Proceeds from advancesrelated party
|
|
|
500,000
|
|
|
|
|
Proceeds from the issuance of restricted stock
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flows provided by financing activities
|
|
|
3,300,006
|
|
|
1,375,000
|
|
|
|
|
|
|
|
|
|
Net change in cash
|
|
|
158,183
|
|
|
(22,484
|
)
|
Cashbeginning of year
|
|
|
148,066
|
|
|
170,550
|
|
|
|
|
|
|
|
|
|
Cashending of year
|
|
$
|
306,249
|
|
$
|
148,066
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements
F-6
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements
December 31, 2015 and 2014
1. Organization and Nature of Business
Madrigal Pharmaceuticals, Inc. (the "Company") was incorporated on August 19, 2011 and commenced operations in September 2011. On September 14, 2011, the Company
entered into an Assignment and Issuance agreement in which the Company was assigned the rights, title and interest in the tangible and intangible assets owned by Bay City Capital Fund IV, L.P.
("Lender A") and Bay City Capital Fund IV Co-Investment Fund, L.P ("Lender B"), collectively BCC in exchange for convertible promissory notes including accrued interest in the amount of approximately
$23,400,000 (See Note 4). Assets contributed to the company were primarily intangible assets related to several drug development programs of VIA Pharmaceuticals, Inc. ("VIA"), which was
an investee company of BCC.
The
underlying assets of VIA that were transferred to BCC and subsequently contributed to Company were notionally valued at $3 million. BCC credit bid $3 million for the
VIA assets as part of an assignment for the benefit of creditors ("ABC") process. Due to the common control nature of the transaction and in accordance with GAAP, the assigned assets and liabilities
were recorded by the
Company at their respective carryover basis which was zero for the tangible and intangible assets and $23.4 million for the assigned debt. In 2012, Madrigal entered into a transaction with
Tallikut Pharmaceuticals, Inc. ("Tallikut") whereby Madrigal sold certain assets to Tallikut in exchange for the assumption of $2 million of convertible promissory notes.
The
Company is developing novel, high-quality small-molecule drugs addressing major unmet needs in cardiovascular and metabolic diseases. The lead compound MGL-3196 is Phase-2 ready and
is being advanced for indications in dyslipidemia, particularly LDL-cholesterol lowering, and non-alcoholic steatohepatitis, a liver disease that commonly affects people with metabolic diseases such
as obesity and diabetes.
The
Company is subject to risks common to emerging companies in the drug development and pharmaceutical industry including, but not limited to, uncertainty of product development and
commercialization, lack of marketing and sales history, dependence on key personnel, uncertainty of market acceptance of products and product reimbursement, product liability, uncertain protection of
proprietary technology, potential inability to raise additional financing necessary for development and commercialization, if applicable, and compliance with the U.S. Food and Drug Administration and
other government regulations.
2. Liquidity and Ability to Continue as a Going Concern
The financial statements have been prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company as a going concern. The Company has
incurred losses since inception, including approximately $6,845,000 in the year ended December 31, 2015, resulting in an accumulated deficit of approximately $48,913,000 as of
December 31, 2015. Management expects to incur losses for the foreseeable future and has a working capital deficit of approximately $48,913,000 at December 31, 2015. The Company has
funded itself primarily through the issuance of convertible debt with a maturity date of December 31, 2016.
The
Company will be required to obtain additional financing and capital and expects to satisfy its cash needs primarily from the additional issuance of convertible debt in order to
sustain operations until it can achieve profitability and positive cash flows, if ever. The Company may also be required to obtain other sources of funding to sustain its current operations and meet
its development objectives.
F-7
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
2. Liquidity and Ability to Continue as a Going Concern (Continued)
During
2016, the Company commenced negotiations to effect a reverse merger concurrently with a private financing. There can be no assurances, however, that the reverse merger transaction or additional
funding, either through the issuance of convertible debt or other sources, will be available on favorable terms, or at all. If adequate funds are not available, the Company may be required to delay,
significantly modify or terminate its research and development programs.
All
of the above matters raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
3. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to
make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenues and expenses during the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under
the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash
equivalents. The Company maintains its cash in a bank account, which at times, exceeds Federal Deposit Insurance Corporation ("FDIC") insured limits.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing
research and development activities, including internal costs, costs for consultants, associated with the Company's preclinical and clinical programs. In particular, Madrigal has conducted safety
studies in animals, optimized and implemented the API manufacturing, and conducted Phase 1 clinical trials, all of which are considered research and development expenditures.
Patents
Costs to secure and defend patents are expensed as incurred and are classified as general and administrative expense in the Company's
statements of operations. Patent expenses were approximately $62,300 and $0 for the years ended December 31, 2015 and 2014, respectively.
Income Taxes
The Company uses the asset and liability method to account for income taxes. Deferred tax assets and liabilities are determined based
on the expected future tax consequences of temporary differences
F-8
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
3. Summary of Significant Accounting Policies (Continued)
between
the Company's financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are
expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized.
Recent Accounting Pronouncements
In August, 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU")
No. 2014-15Presentation of Financial Statements, Disclosures of Uncertainties about an Entity's ability to Continue as a Going Concern. The ASU requires Management to evaluate
whether there are conditions and events that raise substantial
doubt about the Company's ability to continue as a going concern within one year after the financial statements are issued and if Management's plans will alleviate that doubt. Management will be
required to make this evaluation for both annual and interim periods. The accounting guidance is effective beginning in the first quarter of 2016.
In
April 2015, the FASB issued an Accounting Standards Update which requires that debt issuance costs be presented in the balance sheet as a direct reduction to the carrying amount of
the associated debt liability, consistent with debt discounts. Currently debt issuance costs are recognized as an asset. The ASU is effective for the Company in the first quarter of 2016 and is
required to be applied retrospectively. Early adoption is permitted. The Company does not expect the adoption of this standard to have a material impact on its results of operations, financial
position, and cash flows.
In
November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes, which amends the guidance requiring companies to
separate deferred income tax liabilities and assets into current and non-current amounts in a classified statement of financial position. This accounting guidance simplifies the presentation of
deferred income taxes, such that deferred tax liabilities and assets be classified as non-current in a classified statement of financial position. This determination is still required to be performed
at a jurisdiction-by-jurisdiction basis. The accounting guidance is effective beginning in the first quarter of 2017.
4. Convertible Promissory NotesRelated Party
-
A)
-
September 14, 2011 Notes
On
September 14, 2011, the Company was assigned (See Note 1) convertible promissory notes ("the September 14, 2011 Notes") pursuant to an Assignment and Issuance
Agreement, with Lender A and Lender B or collectively the "Lender(s)". Lender A and Lender B are stockholders of the Company. Interest on the outstanding principal accrues and compounds monthly at 8%
per annum. Accrued and unpaid interest shall either be paid upon repayment or converted with the outstanding principal amount. The notes are collateralized by all assets of the Company. The initial
maturity date was the earliest of December 31, 2012 or an event of default as defined in the agreement. The September 14, 2011 Notes have been amended on various dates with each
amendment extending the
F-9
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
4. Convertible Promissory NotesRelated Party (Continued)
maturity
date. The current maturity date is December 31, 2016. The September 14, 2011 Notes can be converted as follows:
-
(a)
-
Optional
ConversionThird Party Financing
. At any time following the closing of a preferred equity financing by the
Company led by an outside investor ("Third Party"), all outstanding principal and interest ("Accreted Value") may, at the option of the Lenders, be converted into equity securities of the Company,
having the same rights, preferences and privileges as the securities issued in the Third Party financing ("Third Party Led Securities"). The numbers of shares of Third Party Led Securities to be
issued upon such conversion shall be equal to the quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) eighty percent (80%) of the per share purchase
price of the Third Party Led Securities.
-
(b)
-
Optional
ConversionSeries A Preferred Stock.
At any time, all Accreted Value may, at the option of the
Lenders, be converted into shares of the Company's Series A Preferred Stock. The number of shares of Series A Preferred Stock to be issued upon such conversion shall be equal to the
quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) The original issue prices of the Series A Preferred Stock.
-
(c)
-
Optional
ConversionCommon Stock.
At any time, Lenders may convert all or any portion of the Accreted Value of the
Note into common shares of the Company with the number of common shares issuable upon such conversion to equal the quotient obtained by dividing (a) the Accreted Value on the date of conversion
by (b) 14.29759. Any Third Party Led Securities and Series A Preferred Stock issued to the Lenders shall be convertible at any time at the option of Lenders into common stock of the
Company.
-
(d)
-
Mandatory
Conversion
. If the principal and interest of the convertible note has not been repaid in full by the maturity date,
the Accreted Value shall automatically convert into common stock of the Company. The conversion price shall be a price per share equal to the per share value of the Company's common stock at the time
of conversion.
ASC
815 requires that a conversion feature should be accounted for as a derivative when specific criteria are met. The Company has determined that the conversion features do not meet the
criteria for derivative accounting as the underlying stock cannot be readily converted into cash due to the lack of an active market. This assessment will be made on an ongoing basis throughout the
contracts life.
-
B)
-
September 16, 2011 Notes
On
September 16, 2011, the Company entered into a Note Purchase Agreement with Lender A and Lender B in which the Company agrees to sell and issue to the Lenders secured
convertible promissory notes ("the September 16, 2011 Notes"). Interest on the outstanding principal accrues and compounds monthly at 8% per annum. Accrued and unpaid interest shall either be
paid upon repayment or converted with the outstanding principal amount. The notes are collateralized by all assets of the Company. The initial maturity date was the earliest of October 31, 2012
or an event of default as defined in the agreement. The September 16, 2011 notes have been amended on various
F-10
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
4. Convertible Promissory NotesRelated Party (Continued)
dates
with each amendment extending the maturity date. The current maturity date is December 31, 2016. The September 16, 2011 notes can by converted as
follows:
-
(a)
-
Optional
ConversionThird Party Financing
. At any time following the closing of a preferred equity financing by the
Company led by Third Party, all Accreted Value may, at the option of the Lenders, be converted into equity securities of the Company, having the same rights, preferences and privileges as the
securities issued in the Third Party financing. The numbers of shares of Third Party Led Securities to be issued upon such conversion shall be equal to the quotient obtained by dividing (a) the
Accreted Value on the date of conversion by (b) eighty percent (80%) of the per share purchase price of the Third Party Led Securities.
In
addition, the Company shall issue to each Lender, upon conversion of such Lender's note, a warrant to purchase from the Company up to the number of fully paid and nonassessable shares of Third
Party Led Securities sold in such Third Party Financing that equals the quotient obtained by dividing (a) ten percent (10%) of the original principal amount of the notes issued to such Lenders
pursuant to the Note Purchase Agreement by (b) the per share purchase price of the Third Party Led Securities. The Company has not issued any warrants to date or during the years ended
December 31, 2015 and 2014.
-
(b)
-
Optional
ConversionSeries A Preferred Stock.
At any time, all Accreted Value may, at the option of the
Lenders, be converted into shares of the Company's Series A Preferred Stock. The number of shares of Series A Preferred Stock to be issued upon such conversion shall be equal to the
Quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) 14.29759.
ASC
815 requires that a conversion feature should be accounted for as a derivative when specific criteria are met. The Company has determined that the conversion features do not meet the
criteria for derivative accounting as the underlying stock cannot be readily converted into cash due to the lack of an active market. This assessment will be made on an ongoing basis throughout the
contracts life.
The
original issue amount, outstanding principal and interest balance (Accreted Value) by the Lenders are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Original Issue
Amount
|
|
Balance at
12/31/2015
|
|
Balance at
12/31/2014
|
|
September 14, 2011 Notes
|
|
Lender A
|
|
$
|
22,892,829
|
|
$
|
32,258,925
|
|
$
|
29,786,654
|
|
September 14, 2011 Notes
|
|
Lender B
|
|
|
493,451
|
|
|
695,336
|
|
|
642,047
|
|
September 16, 2011 Note Purchase Agreement
|
|
Lender A
|
|
|
12,480,975
|
|
|
15,310,882
|
|
|
11,515,596
|
|
September 16, 2011 Note Purchase Agreement
|
|
Lender B
|
|
|
268,935
|
|
|
330,023
|
|
|
248,216
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
36,136,190
|
|
$
|
48,595,166
|
|
$
|
42,192,513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5. Advances PayableRelated Party
On June 29, 2015 and July 30, 2015 a related party agreed to advance the Company $250,000 and $250,000 to be used for working capital requirements. The advances accrue
interest at a rate of four
F-11
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
5. Advances PayableRelated Party (Continued)
percent
(4%) per annum compounded annually. Accrued and unpaid interest shall be paid upon repayment of the advance. The advances consisted of the following:
|
|
|
|
|
|
|
|
|
|
Balance at
12/31/2015
|
|
Accrued
Interest at
12/31/15
|
|
7/30/2015
|
|
$
|
250,000
|
|
$
|
4,222
|
|
6/29/2015
|
|
|
250,000
|
|
|
5,056
|
|
|
|
|
|
|
|
|
|
|
|
$
|
500,000
|
|
$
|
9,278
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Stockholders' Equity
The Company's Certificate of Incorporation as amended on September 1, 2011 authorizes the Company to issue 35,000,000 shares of Common Stock, $0.0001 par value per share ("Common
Stock"), and 30,000,000 shares of Preferred Stock, $0.0001 par value per share ("Series A Preferred Stock"). Holders of Preferred Stock accrue dividends at 8% per annum. Preferred Stock has
certain rights, preferences and privileges to include preferential payment in liquidation, voting and conversion. In the event of liquidation, dissolution or winding up of the Company, the holders of
Series A Preferred Stock, would be paid an amount per share equal to 14.29759 times the original issue price, plus accruing dividends prior to payment to common stock holders. Each share of
Series A Preferred Stock is entitled to cast the number of votes equal to the whole shares of Common Stock into which the shares of Series A Preferred Stock held are convertible. At
December 31, 2015 and December 31, 2014, the Company had not issued any shares of Preferred Stock.
Issued
and outstanding Common Stock is held solely by Lender A, Lender B and the Company's Acting Chief Executive Officer. Shares of common stock may not be sold, assigned, transferred,
encumbered or disposed of without written agreement between the Company and the stockholder.
7. Income Taxes
At December 31, 2015, the Company had federal net operating loss ("NOL") carryforwards of approximately $19,176,000 and state operating loss carryforwards of
approximately $12,197,000, available to reduce future taxable income, which expire between 2031 and 2035. The Company has unused federal research and development carryforwards of approximately
$456,000. These will begin to expire in 2032.
The
Internal Revenue Code ("IRC") limits the amounts of NOL carryforwards that a Company may use in any one year in the event of certain cumulative changes in ownership over a three-year
period as described in Section 382 of the IRC. Such change in ownership could limit the Company's utilization of the NOL, and could be triggered by subsequent sales of securities by the Company
or stockholders. The deferred tax asset related to the NOL reflected on the financial statements could be affected by this limitation. We have not performed a detailed analysis to determine whether an
ownership change has occurred.
In
assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the deferred tax assets will not be realized. The
ultimate realization of
F-12
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
7. Income Taxes (Continued)
deferred
tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. As there is no assurance of future taxable
income, a full valuation allowance has been established to offset the deferred tax assets. The valuation allowance increased $1,986,500 and increased $862,600 for the years ended December 31,
2015 and 2014, respectively. Changes in the deferred tax asset will be recorded as an income tax benefit or expense on the accompanying statements of operations.
Entities
are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions
and has concluded that as of December 31, 2015 there were no uncertain positions. The 2011 through 2015 tax returns are open to review by the IRS and state taxing authorities. Interest and
penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. There was no income tax related interest and penalties included in the income tax provision for
2015.
Temporary
differences that give rise to deferred tax assets and liabilities are as follows:
|
|
|
|
|
|
|
|
|
|
12/31/2015
|
|
12/31/2014
|
|
Current
|
|
|
|
|
|
|
|
Charitable Contributions
|
|
|
609
|
|
|
|
|
Stock Compensation
|
|
|
228
|
|
|
228
|
|
Other Accruals
|
|
|
|
|
|
22,326
|
|
Valuation Allowance
|
|
|
(837
|
)
|
|
(22,554
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Term
|
|
|
|
|
|
|
|
Intangibles
|
|
|
930,647
|
|
|
1,017,456
|
|
Property, Plant & Equipment
|
|
|
322
|
|
|
904
|
|
Net Operating Losses
|
|
|
7,324,215
|
|
|
5,310,210
|
|
R&D Credit
|
|
|
456,496
|
|
|
374,855
|
|
Valuation Allowance
|
|
|
(8,711,680
|
)
|
|
(6,703,425
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Differences
between the effective income tax rate and the US statutory rate were as follows:
|
|
|
|
|
|
|
|
|
|
2015
|
|
2014
|
|
Federal statutory rate
|
|
|
34.0
|
%
|
|
34.0
|
%
|
Non-deductible interest expenses
|
|
|
10.9
|
%
|
|
15.4
|
%
|
Deferred state income tax expense
|
|
|
4.5
|
%
|
|
0.3
|
%
|
Change in valuation allowance
|
|
|
28.8
|
%
|
|
19.2
|
%
|
Research and development credit
|
|
|
1.2
|
%
|
|
0.9
|
%
|
|
|
|
|
|
|
|
|
Effective Tax Rate
|
|
|
0.0
|
%
|
|
0.0
|
%
|
F-13
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
8. Related Party Transactions
Related party financing
Lender A and B have provided financing to the Company since its inception. For the years ended December 31, 2015 and
December 31, 2014 the Lenders have provided in convertible promissory note financing $2,800,000 and $1,375,000, respectively. For the years ended December 31, 2015 and
December 31, 2014, the Company has incurred approximately $3,603,000 and $3,168,000, respectively in interest expense to the Lenders on outstanding convertible promissory notes payable. At
December 31, 2015 and December 31, 2014, the Company has approximately $48,595,000 and $42,193,000, respectively of convertible promissory notes payable to the Lenders as more fully
described in Note 4.
Travel and legal expenses
The Company has reimbursed Lender A for certain travel expenses in the amounts of approximately $31,000 and $13,500 for the years ended
December 31, 2015 and December 31, 2014, respectively. The Company reimbursed Lender A $41,300 in the year ending December 31, 2015, for certain legal expenses paid on behalf of
the Company for corporate legal matters.
Consulting agreement
The Company has a consulting agreement with its Chief Executive Officer ("CEO"), who is also a stockholder of the Company. The
consulting agreement automatically renews monthly until it is terminated. The consulting agreement can be terminated upon fifteen (15) day notice by the Company or the CEO. The consulting
agreement is in lieu of employment. For the year ended December 31, 2015 and 2014, the Consultant was paid $165,000 in each year.
9. Commitment and contingencies
The Company has a Research, Development and Commercialization Agreement with Hoffmann-La Roche ("Roche") which grants to the Company a sole and exclusive license to develop, use, sell,
offer for sale and import any Licensed Product as defined by the agreement.
The
Company entered Phase 1 clinical trials in 2011 and paid the related milestone payment to Roche on October 12, 2011. The agreement requires future milestone payments to
Roche, the remainder of which total $10.8 million and are earned by the commencement of Phase 2 and Phase 3 clinical trials as well as future regulatory approval in the United States and Europe
of a product developed from MGL-3196. A single-digit royalty payment range is based on net sales of products developed from MGL-3196, subject to certain reductions. The Company has not achieved any
additional product development or regulatory milestones to date and has no Licensed Product sales for the years ending December 31, 2015 and 2014.
The
Company has a Change in Control Bonus Plan ("Bonus Plan") in which certain key service providers of the Company, will be awarded bonuses in the event there is a change in control, as
defined. The purpose of the Bonus Plan is to compensate for past services, and secure to a limited extent, continued services of certain key service providers of the Company. In accordance with the
Bonus Plan, up to 10% of the net proceeds will be paid to eligible participants based upon their participation agreement which will be funded out of the consideration actually provided to the
F-14
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Financial Statements (Continued)
December 31, 2015 and 2014
9. Commitment and contingencies (Continued)
Company
and or the Stockholders of the Company in connection with a change of control transaction and will be the same form of consideration actually transferred.
10. Subsequent Events
On March 1, 2016, the Company entered into a Note Purchase Agreement with Lender A and Lender B in which the Company agrees to sell and issue to the Lenders secured convertible
promissory notes ("the March 1, 2016 Notes"). Interest on the outstanding principal accrues and compounds monthly at 8% per annum. Accrued and unpaid interest shall either be paid upon
repayment or converted with the outstanding principal amount. The Notes have a maturity date of December 31, 2016. The notes can be converted as defined in the March 1, 2016 Note
Purchase Agreement. On March 1, 2016, the Company issued notes to Lender A in the amount of $734,175 and to Lender B in the amount of $15,825.
F-15
Table of Contents
Contents
F-16
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Condensed Balance Sheets
(Unaudited)
|
|
|
|
|
|
|
|
|
|
March 31,
2016
|
|
December 31,
2015
|
|
Assets
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
Cash
|
|
$
|
617,907
|
|
$
|
306,249
|
|
Other receivablerelated party
|
|
|
|
|
|
7,332
|
|
Prepaid expenses
|
|
|
152,532
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
770,439
|
|
|
363,581
|
|
Total assets
|
|
$
|
770,439
|
|
$
|
363,581
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Deficit
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
Convertible promissory notes payablerelated party
|
|
$
|
50,315,161
|
|
$
|
48,595,166
|
|
Advances payablerelated party
|
|
|
500,000
|
|
|
500,000
|
|
Accrued interest on advancesrelated party
|
|
|
14,222
|
|
|
9,278
|
|
Accounts payable
|
|
|
470,130
|
|
|
102,293
|
|
Accrued expenses
|
|
|
96,819
|
|
|
70,203
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
51,396,332
|
|
|
49,276,940
|
|
Total liabilities
|
|
|
51,396,332
|
|
|
49,276,940
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
Stockholders' deficit
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 30,000,000 shares authorized, 0 shares issued and outstanding
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 35,000,000 shares authorized, 1,105,820 shares, issued and outstanding
|
|
|
111
|
|
|
111
|
|
Additional paid-in capital
|
|
|
6,120
|
|
|
6,120
|
|
Accumulated deficit
|
|
|
(50,632,124
|
)
|
|
(48,919,590
|
)
|
|
|
|
|
|
|
|
|
Total stockholders' deficit
|
|
|
(50,625,893
|
)
|
|
(48,913,359
|
)
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' deficit
|
|
$
|
770,439
|
|
$
|
363,581
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements
F-17
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Condensed Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2016
|
|
2015
|
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
515,835
|
|
$
|
343,930
|
|
General and administrative
|
|
|
221,759
|
|
|
195,629
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(737,594
|
)
|
|
(539,559
|
)
|
|
|
|
|
|
|
|
|
Other expenses
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(974,940
|
)
|
|
(842,526
|
)
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,712,534
|
)
|
$
|
(1,382,085
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements
F-18
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Condensed Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2016
|
|
2015
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,712,534
|
)
|
$
|
(1,382,085
|
)
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
PIK interest expense on convertible promissory notes payablerelated party
|
|
|
969,995
|
|
|
842,526
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
Other receivablerelated party
|
|
|
7,332
|
|
|
|
|
Prepaid expenses
|
|
|
(102,532
|
)
|
|
(50,000
|
)
|
Accounts payable
|
|
|
367,837
|
|
|
65,764
|
|
Accrued expenses
|
|
|
26,616
|
|
|
41,250
|
|
Accrued interestrelated party
|
|
|
4,944
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments
|
|
|
1,274,192
|
|
|
899,540
|
|
|
|
|
|
|
|
|
|
Net cash used in operations
|
|
|
(438,342
|
)
|
|
(482,545
|
)
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
Proceeds from convertible notesrelated party
|
|
|
750,000
|
|
|
1,050,000
|
|
|
|
|
|
|
|
|
|
Net cash flows provided by financing activities
|
|
|
750,000
|
|
|
1,050,000
|
|
|
|
|
|
|
|
|
|
Net change in cash
|
|
|
311,658
|
|
|
567,455
|
|
Cashbeginning of period
|
|
|
306,249
|
|
|
148,066
|
|
|
|
|
|
|
|
|
|
Cashending of period
|
|
$
|
617,907
|
|
$
|
715,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements
F-19
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(Unaudited)
1. Organization and Nature of Business
Madrigal Pharmaceuticals, Inc. (the "Company") was incorporated on August 19, 2011 and commenced operations in September 2011. On September 14, 2011, the Company
entered into an Assignment and Issuance Agreement in which the Company was assigned the rights, title and interest in and to the tangible and intangible assets owned by Bay City Capital Fund
IV, L.P. ("Lender A") and Bay City Capital Fund IV Co-Investment Fund, L.P ("Lender B" and together with Lender A, "BCC"), in exchange for the assumption of outstanding convertible promissory
notes, including accrued interest, in the amount of approximately $23,400,000 (See Note 4). Assets contributed to the Company were primarily intangible assets related to several drug
development programs of VIA Pharmaceuticals, Inc. ("VIA"), which was an investee company of BCC.
The
underlying assets of VIA that were transferred to BCC and subsequently contributed to the Company were notionally valued at $3 million. BCC credit bid $3 million for
the VIA assets as part of an assignment for the benefit of creditors process. Due to the common control nature of the transaction and in accordance with accounting principles generally accepted in the
United States of America ("GAAP"), the assigned assets and liabilities were recorded by the Company at their respective carryover basis which was zero for the tangible and intangible assets and
$23.4 million for the assumed debt. In 2012, Madrigal entered into a transaction with Tallikut Pharmaceuticals, Inc. ("Tallikut") whereby Madrigal sold certain assets to Tallikut in
exchange for the assumption of $2 million of convertible promissory notes.
The
Company is developing novel, high-quality small-molecule drugs addressing major unmet needs in cardiovascular and metabolic diseases. The lead compound MGL-3196 is Phase-2 ready and
is being advanced for indications in dyslipidemia, particularly LDL-cholesterol lowering, and non-alcoholic steatohepatitis, a liver disease that commonly affects people with metabolic diseases such
as obesity and diabetes.
The
Company is subject to risks common to emerging companies in the drug development and pharmaceutical industry including, but not limited to, uncertainty of product development and
commercialization, lack of marketing and sales history, dependence on key personnel, uncertainty of
market acceptance of products and product reimbursement, product liability, uncertain protection of proprietary technology, potential inability to raise additional financing necessary for development
and commercialization, if applicable, and compliance with the U.S. Food and Drug Administration and other government regulations.
Certain
information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States
(U.S. GAAP) have been condensed or omitted. However, we believe that the disclosures included in these financial statements are adequate to make the information presented not misleading. The
unaudited condensed financial statements included in this document have been prepared on the same basis as the annual financial statements, and in our opinion reflect all adjustments, which include
normal recurring adjustments necessary for a fair presentation in accordance with GAAP regulations for interim financial statements. The results for the three months ended March 31, 2016 are
not necessarily indicative of the results that we will have for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited consolidated
financial statements and the notes to those statements for the year ended December 31, 2015.
F-20
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
2. Liquidity and Ability to Continue as a Going Concern
The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP") which contemplate continuation of the
Company as a going concern. The Company has incurred losses since inception, including approximately $1,713,000 in the quarter ended March 31, 2016, resulting in an accumulated deficit of
approximately $50,632,000 as of March 31, 2016. Management expects to incur losses for the foreseeable future and has a working capital deficit of approximately $50,626,000 at March 31,
2016. To date, the Company has funded its operations primarily through the issuance of convertible debt with a maturity date of
December 31, 2016. As of March 31, 2016 the Company had approximately $618,000 of cash which will not be sufficient to fund the operations of the Company and make the contractual debt
payments under the convertible promissory note agreements. This raises substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
On
April 13, 2016, the Company amended and restated the terms of its March 1, 2016 Note Purchase Agreement to increase the principal amount of the notes available to
$9,000,000 (see Note 4). The maturity date of the Amended notes is the earliest of December 31, 2016 or an event of default as defined in the agreement. The Company amended and restated
the March 1, 2016 Note Purchase Agreement in order to provide funds to the Company for working capital and general corporate purposes through the date of the anticipated merger discussed below.
In addition, the September 16, 2011 and March 1, 2016 note purchase agreements were amended in April 2016 to add mandatory conversion features to the underlying notes whereby the
principal on the notes will automatically convert into shares of common stock of the Company at $1.00 and $1.07581 per share, respectively, upon the consummation of the merger.
On
April 13, 2016, the Company entered into an Agreement and Plan of Merger and Reorganization with Synta Pharmaceuticals Corp. ("Synta") (see Note 9). Consummation of the
merger is subject to certain closing conditions including, among other things, approval by the stockholders of Synta, and is expected to be completed in the third quarter of 2016. The working capital
obtained through the merger together with the proceeds from the issuance of notes under the Amended and Restated Note Purchase Agreement, the waiver of accrued interest under all convertible
promissory notes of the Company and the conversion of all outstanding convertible notes (see Note 4 and Note 9) is anticipated to fund the Company's operations for at least the next
twelve months from the balance sheet date. However, there can be no assurances that the merger will be consummated or other sources of funding will be available on favorable terms, or at all. If
adequate funds are not available, the Company may be required to delay, significantly modify or terminate its research and development programs, all of which would have a material effect on the
Company.
3. Summary of Significant Accounting Policies
Condensed Interim Financial Statements
The accompanying unaudited condensed financial statements have been prepared in accordance with GAAP. Certain information and note
disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. We believe the disclosures included in these financial statements are adequate to
prevent the information presented from being misleading. The results for the three months ended March 31, 2016 are not necessarily indicative of the
F-21
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
3. Summary of Significant Accounting Policies (Continued)
results
that we will have for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those financial
statements for the year ended December 31, 2015.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect
certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during
the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates
are recorded in the period in which they become known. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash
equivalents. The Company maintains its cash in a bank account, which at times, exceeds Federal Deposit Insurance Corporation ("FDIC") insured limits.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing
research and development activities, including internal costs, costs for consultants, associated with the Company's preclinical and clinical programs. In particular, Madrigal has conducted safety
studies in animals, optimized and implemented the API manufacturing, and conducted Phase 1 clinical trials, all of which are considered research and development expenditures.
Patents
Costs to secure and defend patents are expensed as incurred and are classified as general and administrative expense in the Company's
statements of operations. Patent expenses were approximately $6,500 and $45,800 for the quarter ended March 31, 2016 and 2015, respectively.
Income Taxes
The Company uses the asset and liability method to account for income taxes. Deferred tax assets and liabilities are determined based
on the expected future tax consequences of temporary differences between the Company's financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected
to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be
realized.
F-22
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
4. Convertible Promissory NotesRelated Party
September 14, 2011 Notes
On September 14, 2011, the Company was assigned (See Note 1) convertible promissory notes (the "September 14, 2011
Notes") pursuant to an Assignment and Issuance Agreement, with Lender A and Lender B or collectively the "Lender(s)". Lender A and Lender B are stockholders of the Company. Interest on the outstanding
principal accrues and compounds monthly at 8% per annum. Accrued and unpaid interest shall either be paid upon principal repayment or converted with the outstanding principal amount. The notes are
collateralized by all assets of the Company. The initial maturity date was the earliest of December 31, 2012 or an event of default as defined in the agreement. The September 14, 2011
Notes have been amended on various dates with each amendment extending the maturity date. The current maturity date is December 31, 2016. The September 14, 2011 Notes can be converted as
follows:
-
(a)
-
Optional
ConversionThird Party Financing.
At any time following the closing of a preferred equity financing with
an outside investor ("Third Party"), all outstanding principal and interest ("Accreted Value") may, at the option of the Lenders, be converted into equity securities of the Company, having the same
rights, preferences and privileges as the securities issued in the Third Party financing ("Third Party Led Securities"). The numbers of shares to be issued upon such conversion shall be equal to the
quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) eighty percent (80%) of the per share purchase price of the Third Party Led Securities.
-
(b)
-
Optional
ConversionSeries A Preferred Stock.
At any time, all Accreted Value may, at the option of the
Lenders, be converted into shares of the Company's Series A Preferred Stock. The number of shares of Series A Preferred Stock to be issued upon such conversion shall be equal to the
quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) the original issue prices of the Series A Preferred Stock.
-
(c)
-
Optional
ConversionCommon Stock.
At any time, Lenders may convert all or any portion of the Accreted Value of the
Note into common shares of the Company with the number of common shares issuable upon such conversion to equal the quotient obtained by dividing (a) the Accreted Value on the date of conversion
by (b) 14.29759. Any Third Party Led Securities and Series A Preferred Stock issued to the Lenders shall be convertible at any time at the option of Lenders into common stock of the
Company.
-
(d)
-
Mandatory
Conversion.
If the principal and interest of the convertible note has not been repaid in full by the maturity date,
the Accreted Value shall automatically convert into common stock of the Company. The conversion price shall equal to the per share value of the Company's common stock at the time of conversion.
ASC
815 requires that a conversion feature be accounted for as a derivative when specific criteria are met. The Company has determined that the conversion features do not meet the
criteria for derivative accounting as the underlying stock cannot be readily converted into cash due to the lack of an active market. This assessment will be made on an ongoing basis throughout the
contract's life.
F-23
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
4. Convertible Promissory NotesRelated Party (Continued)
September 16, 2011 Notes
On September 16, 2011, the Company entered into a Note Purchase Agreement with Lender A and Lender B in which the Company agrees
to sell and issue to the Lenders secured convertible promissory notes ("the September 16, 2011 Notes"). Interest on the outstanding principal accrues and compounds monthly at 8% per annum.
Accrued and unpaid interest shall either be paid upon principal repayment or converted with the outstanding principal amount. The notes are
collateralized by all assets of the Company. The initial maturity date was the earliest of October 31, 2012 or an event of default as defined in the agreement. The September 16, 2011
notes have been amended on various dates with each amendment extending the maturity date. The current maturity date is December 31, 2016. The September 16, 2011 notes can by converted as
follows:
-
(a)
-
Optional
ConversionThird Party Financing.
At any time following the closing of a preferred equity financing with a
Third Party, all Accreted Value may, at the option of the Lenders, be converted into equity securities of the Company, having the same rights, preferences and privileges as the securities issued in
the Third Party financing. The numbers of shares to be issued upon such conversion shall be equal to the quotient obtained by dividing (a) the Accreted Value on the date of conversion by
(b) eighty percent (80%) of the per share purchase price of the Third Party Led Securities.
In
addition, the Company shall issue to each Lender, upon conversion of such Lender's note, a warrant to purchase up to the number of shares of Third Party Led Securities sold in such Third Party
Financing that equals the quotient obtained by dividing (a) ten percent (10%) of the original principal amount of the notes issued to such Lenders pursuant to the Note Purchase Agreement by
(b) the per share purchase price of the Third Party Led Securities. The Company has not issued any warrants to date.
-
(b)
-
Optional
ConversionSeries A Preferred Stock.
At any time, all Accreted Value may, at the option of the
Lenders, be converted into shares of the Company's Series A Preferred Stock. The number of shares of Series A Preferred Stock to be issued upon such conversion shall be equal to the
Quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) 14.29759.
ASC
815 requires that a conversion feature be accounted for as a derivative when specific criteria are met. The Company has determined that the conversion features do not meet the
criteria for derivative accounting as the underlying stock cannot be readily converted into cash due to the lack of an active market. This assessment will be made on an ongoing basis throughout the
contract's life.
March 1, 2016 Notes
On March 1, 2016, the Company entered into a Note Purchase Agreement with Lender A and Lender B in which the Company agreed to
sell and issue to the Lenders secured convertible promissory notes ("the March 1, 2016 Notes") in the amount of up to $2,000,000. Interest on the outstanding principal accrues and compounds
monthly at 8% per annum. Accrued and unpaid interest shall either be paid upon repayment or converted with the outstanding principal amount. The notes are collateralized by all assets of the Company.
The maturity date is the earliest of December 31, 2016 or
F-24
Table of Contents
MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
4. Convertible Promissory NotesRelated Party (Continued)
an
event of default as defined in the agreement. On March 1, 2016, the first closing date, $750,000 aggregate principal amount was issued. The March 1, 2016 notes can by converted as
follows:
-
(a)
-
Optional
ConversionThird Party Financing.
At any time following the closing of a preferred equity financing by the
Company led by a Third Party, all Accreted Value may, at the option of the Lenders, be converted into equity securities of the Company, having the same rights, preferences and privileges as the
securities issued in the Third Party financing . The numbers of shares to be issued upon such conversion shall be equal to the quotient obtained by dividing (a) the Accreted Value on the date
of conversion by (b) the per share purchase price of the Third Party Led Securities.
-
(b)
-
Optional
ConversionSeries A Preferred Stock.
At any time, all Accreted Value may, at the option of the
Lenders, be converted into shares of the Company's Series A Preferred Stock. The number of shares of Series A Preferred Stock to be issued upon such conversion shall be equal to the
Quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) the original issue price of the Series A Preferred Stock.
-
(c)
-
Optional
ConversionCommon Stock.
At any time, Lenders may convert all of the Accreted Value of the Note into
common shares of the Company with the number of common shares issuable upon such conversion to equal the quotient obtained by dividing (a) the Accreted Value on the date of conversion by
(b) the then per share fair market value of Common Stock. Any Third Party Led Securities and Series A Preferred Stock issued to the Lenders shall be convertible at any time at the option
of Lenders into common stock of the Company.
ASC
815 requires that a conversion feature be accounted for as a derivative when specific criteria are met. The Company has determined that the conversion features do not meet the
criteria for derivative accounting as the underlying stock cannot be readily converted into cash due to the lack of an active market. This assessment will be made on an ongoing basis throughout the
contract's life.
The
original issue amount, outstanding principal and interest balance (Accreted Value) by the Lenders are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Original Issue
Amount
|
|
Balance at
March 31, 2016
|
|
Balance at
December 31, 2015
|
|
September 14, 2011 Notes
|
|
Lender A
|
|
$
|
22,892,829
|
|
$
|
32,899,454
|
|
$
|
32,258,925
|
|
September 14, 2011 Notes
|
|
Lender B
|
|
|
493,451
|
|
|
709,142
|
|
|
695,336
|
|
September 16, 2011 Note Purchase Agreement
|
|
Lender A
|
|
|
12,480,975
|
|
|
15,614,893
|
|
|
15,310,882
|
|
September 16, 2011 Note Purchase Agreement
|
|
Lender B
|
|
|
268,935
|
|
|
336,576
|
|
|
330,023
|
|
March 1, 2016 Note Purchase Agreement
|
|
Lender A
|
|
|
734,175
|
|
|
739,163
|
|
|
|
|
March 1, 2016 Note Purchase Agreement
|
|
Lender B
|
|
|
15,825
|
|
|
15,933
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
36,886,190
|
|
$
|
50,315,161
|
|
$
|
48,595,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
4. Convertible Promissory NotesRelated Party (Continued)
Subsequent Convertible Promissory Note Amendments:
Effective April 13, 2016, the Lenders collectively waived all accrued interest under the September 14 and
September 16, 2011, and March 1, 2016 convertible note issuances. The total accrued and waived interest amounted to $13,680,000. No additional interest on these notes will be accrued
through the date on which the Merger Agreement with Synta (see Note 9) is consummated or terminated, as defined in the agreement. Upon consummation of the Merger, the September 14 and
September 16, 2011, and March 1, 2016 convertible note issuances outstanding will be converted to common stock of the Company.
September 14, 2011 Notes (Amended and Restated April 13, 2016)
On April 13, 2016, the Company amended and restated the terms of the September 14, 2011 Assignment and Issuance Agreement
to modify the conversion terms of the September 14, 2011 notes to include the following:
-
(a)
-
Optional
ConversionCommon Stock.
At any time following the date on which the Merger Agreement is terminated as
defined in the agreement, Lenders may convert all of the Accreted Value of the Note into common shares of the Company with the number of common shares issuable upon such conversion to equal the
quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) 1.00.
-
(b)
-
Mandatory
Conversion Upon a Merger with Synta.
If Merger is consummated prior to the maturity date all Accreted Value will
automatically be converted into shares of Common Stock of the Company. The number of shares of Common Stock to be issued upon such conversion shall be equal to the quotient obtained by dividing
(a) the Accreted Value on the date of conversion by (b) 1.00.
September 16, 2011 Notes (Amended and Restated April 13, 2016)
On April 13, 2016, the Company amended and restated the terms of its September 16, 2011 Note Purchase Agreement to modify
the conversion terms of the September 16, 2011 notes to include the following :
-
(c)
-
Optional
ConversionCommon Stock.
At any time following the date on which the Merger Agreement is terminated as
defined in the agreement, Lenders may convert all of the Accreted Value of the Note into common shares of the Company with the number of common shares issuable upon such conversion to equal the
quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) 1.00.
-
(d)
-
Optional
ConversionSeries A Preferred Stock.
At any time following the date on which the Merger Agreement
is terminated as defined in the agreement, Lenders may convert all of the Accreted Value of the Note into Series A Preferred Stock of the Company, $0.0001 par value per share ("Series A
Preferred Stock") with the number of Series A Preferred Stock issuable upon such conversion to equal the quotient obtained by dividing (a) the Accreted Value on the date of conversion by
(b) the original issue price of the Series A Preferred Stock, as adjusted for splits, dividends and the like.
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
4. Convertible Promissory NotesRelated Party (Continued)
-
(e)
-
Mandatory
Conversion Upon a Merger with Synta.
If Merger is consummated prior to the maturity date all Accreted Value will
automatically be converted into shares of Common Stock of the Company. The number of shares of Common Stock to be issued upon such conversion shall be equal to the quotient obtained by dividing
(a) the Accreted Value on the date of conversion by (b) 1.00.
March 1, 2016 Notes (Amended and Restated April 13, 2016)
On April 13, 2016, the Company amended and restated the terms of its March 1, 2016 Note Purchase Agreement to increase
the principal amount of notes available for issuance to $9,000,000, to be funded at specific dates in accordance with a funding schedule, and to add two additional related party lenders ("Lender C"
and "Lender D"). The notes are collateralized by all assets of the Company and are senior in right of payment to all outstanding indebtedness of the Company. The maturity date is the earliest of
December 31, 2016, the date the Merger Agreement is terminated (see Note 9), or an event of default as defined in the agreement. The conversion terms of the March 1, 2016 notes
were amended to include the following:
-
(a)
-
Optional
Conversion-Qualified Financing.
At any time following the closing of a preferred equity financing of the Company (a
"Qualified Financing"), all Accreted Value may, at the option of the Lenders, be converted into equity securities of the Company of the same class and having the same rights, preferences and
privileges as the securities issued in the Qualified Financing (the "Qualified Financing Securities"). The number of shares of Qualified Financing Securities to be issued upon such conversion shall be
equal to the quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) the product of 0.85 times the lowest per share purchase price of the Qualified
Financing Securities paid by the other investors in the Qualified Financing.
-
(b)
-
Optional
ConversionSeries A Preferred Stock.
At any time following the date on which the Merger Agreement
is terminated as defined in the agreement, all Accreted Value may, at the option of the Lenders, be converted into shares of the Company's Series A Preferred Stock. The number of shares of
Series A Preferred Stock to be issued upon such conversion shall be equal to the Quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) the original
issue price of the Series A Preferred Stock.
-
(c)
-
Optional
ConversionCommon Stock.
At any time following the date on which the Merger Agreement is terminated as
defined in the agreement, Lenders may convert all of the Accreted Value of the Note into common shares of the Company with the number of common shares issuable upon such conversion to equal the
quotient obtained by dividing (a) the Accreted Value on the date of conversion by (b) 1.07581.
-
(d)
-
Mandatory
Conversion Upon a Merger with Synta.
If Merger is consummated prior to the maturity date all Accreted Value will
automatically be converted into shares of Common Stock of the Company. The number of shares of Common Stock to be issued upon such conversion shall be equal to the quotient obtained by dividing
(a) the Accreted Value on the date of conversion by (b) 1.07581.
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
4. Convertible Promissory NotesRelated Party (Continued)
On
April 13, 2016, the Company issued two notes in the amounts of $1,875,000 to Lender C and $750,000 to Lender D in accordance with terms of the March 1, 2016 Amended and
Restated Note Purchase Agreement. The note issued to Lender D includes $500,000 of prior Advances Payable which was deemed contributed by Lender D to the Company in exchange for $500,000 in notes as
of April 13, 2016. The Company also received $250,000 in cash from Lender D. On May 17, 2016, the Company issued three notes in the amounts of $435,040, $9,360 and $1,111,200 to Lender
A, Lender B and Lender C, respectively, in accordance with the terms of the March 1, 2016 Amended and Restated Note Purchase Agreement.
As
of April 13, 2016, these convertible notes total $39.5 million will be converted into 39,273,451 shares of common stock of the Company. Additional convertible notes
issued under the March 1, 2016 Amended and Restated Note Purchase Agreement will convert into shares of common stock of the Company in accordance with the terms noted above.
5. Advances PayableRelated Party
On June 29, 2015 and July 30, 2015 a related party agreed to advance the Company $250,000 and $250,000 to be used for working capital requirements. The advances accrue
interest at a rate of four percent (4%) per annum compounded annually. Accrued and unpaid interest shall be paid upon repayment of the advance. Unpaid accrued interest as of March 31, 2016 and
December 31, 2016 was $14,222 and $9,278, respectively. On April 13, 2016, these advances were exchanged for $500,000 in convertible promissory notes payable and all accrued interest was
waived (see Note 4).
6. Stockholders' Equity
The Company's Certificate of Incorporation as amended on September 1, 2011 authorizes the Company to issue 35,000,000 shares of Common Stock, $0.0001 par value per share ("Common
Stock"), and 30,000,000 shares of Preferred Stock, $0.0001 par value per share ("Series A Preferred Stock"). Holders of Preferred Stock accrue dividends at 8% per annum. Preferred Stock has
certain rights, preferences and privileges to include preferential payment in liquidation, voting and conversion. In the event of liquidation, dissolution or winding up of the Company, the holders of
Series A Preferred Stock, would be paid an amount per share equal to 14.29759 times the original issue price, plus accruing dividends
prior to payment to common stock holders. Each share of Series A Preferred Stock is entitled to cast the number of votes equal to the whole shares of Common Stock into which the shares of
Series A Preferred Stock held are convertible. At March 31, 2016 and December 31, 2015, the Company had not issued any shares of Preferred Stock.
Issued
and outstanding Common Stock is held solely by Lender A, Lender B and the Company's Chief Executive Officer. Shares of common stock may not be sold, assigned, transferred,
encumbered or disposed of without written agreement between the Company and the stockholder.
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
7. Related Party Transactions
Related party financing
Lenders A and B have provided financing to the Company since its inception. Lenders A, B, C and D have agreed to provide funding under
the April 13, 2016 amended and restated March 1, 2016 agreement. For the quarters ended March 31, 2016 and March 31, 2015 Lenders A and B have provided convertible
promissory note financing of $750,000 and $1,050,000, respectively. For the quarters ended March 31, 2016 and March 31, 2015, the Company has incurred
approximately $970,000 and $842,000, respectively in interest expense to these Lenders A and B which was subsequently waived. At March 31, 2016 and December 31, 2015, the Company has
approximately $50,315,000 and $48,595,000 respectively of convertible promissory notes payable to the Lenders as more fully described in Note 4.
Travel expenses
The Company has reimbursed Lender A for travel expenses in the amounts of approximately $8,600 and $0 for the quarters ended
March 31, 2016 and March 31, 2015, respectively.
Consulting agreement
The Company has a consulting agreement with its Chief Executive Officer ("CEO"), who is also a stockholder of the Company. The
consulting agreement automatically renews monthly until it is terminated. The consulting agreement can be terminated upon fifteen (15) day notice by the Company or the CEO. For the quarters
ended March 31, 2016 and 2015, the consultant was paid $41,250 in each quarter.
8. Commitment and contingencies
The Company has a Research, Development and Commercialization Agreement with Hoffmann-La Roche ("Roche") which grants to the Company a sole and exclusive license to develop, use, sell,
offer for sale and import any Licensed Product as defined by the agreement.
The
Company entered Phase 1 clinical trials in 2011 and paid the related milestone payment to Roche on October 12, 2011. The agreement requires future milestone payments to
Roche, the remainder of which total $10.8 million and are earned by the commencement of Phase 2 and Phase 3 clinical trials as well as future regulatory approval in the United
States and Europe of a product developed from MGL-3196. A single-digit royalty payment range is based on net sales of products developed from MGL-3196, subject to certain reductions.
The
Company has not achieved any additional product development or regulatory milestones to date and has no Licensed Product sales for the quarter ending March 31, 2016 and 2015.
The
Company has a Change in Control Bonus Plan ("Bonus Plan") in which certain key service providers of the Company, will be awarded bonuses in the event there is a change in control, as
defined. The purpose of the Bonus Plan is to compensate for past services, and secure to a limited extent, continued services of certain key service providers of the Company. In accordance with the
Bonus Plan, up to 10% of the net proceeds, as defined, will be paid to eligible participants based upon their participation agreement which will be funded out of the consideration actually provided to
the
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
8. Commitment and contingencies (Continued)
Company
and or the Stockholders of the Company in connection with a change of control transaction and will be the same form of consideration actually transferred.
The
Company is party to an agreement with a financial advisor under which the Company will be required to pay a success fee of 1.5% of consideration received, as defined in the
agreement, upon the consummation of a definitive strategic transaction with a third party.
9. Subsequent Events
Merger Agreement
On April 13, 2016, the Company, Synta Pharmaceuticals Corp. ("Synta"), and Saffron Merger Sub, Inc., a wholly owned
subsidiary of Synta ("Merger Sub "), entered into an Agreement and Plan of Merger and Reorganization (the "Merger Agreement "), pursuant to which, among other things, subject to the satisfaction or
waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Madrigal, with Madrigal becoming a wholly-owned subsidiary of Synta and the surviving corporation of the
merger (the "Merger"). The transaction was approved by the Board of Directors of both Synta and Madrigal, and has received the requisite stockholder approval of the Madrigal stockholders. Consummation
of the Merger is subject to certain
closing conditions, including, among other things, approval by the stockholders of Synta, and is expected to be completed in the third quarter of 2016.
Subject
to the terms and conditions of the Merger Agreement, at the closing of the Merger, each outstanding share of Madrigal common stock will be converted into the right to receive
5.5740 shares of common stock of the Post-Merger Company. Immediately following the effective time of the Merger, the former stockholders of Madrigal are expected to own approximately 64% of the
outstanding capital stock of the Post-Merger Company.
The
Merger Agreement contains certain termination rights for both Synta and Madrigal, and further provides that, upon termination of the Merger Agreement under specified circumstances,
Synta may be required to pay Madrigal a termination fee of $1.25 million or up to $250,000 in expense reimbursements.
Madrigal
has entered into a bridge financing agreement with certain investors that have committed to invest up to $9 million in Madrigal prior to the closing of the Merger (See
Note 4). The combined company intends to use these proceeds, in addition to Synta's cash balance at the closing of the Merger, to fund the development of MGL-3196 through Phase 2
clinical studies in non-alcoholic steatohepatitis (NASH) and heterozygous and homozygous familial hypercholesterolemia (HeFH, HoFH).
Upon
consummation of the Merger, the September 14, 2011, September 16, 2011, March 1, 2016 convertible note issuances outstanding totaling $39.5 million will
be converted into 39,273,451 shares of common stock of the Company.
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MADRIGAL PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Continued)
(Unaudited)
9. Subsequent Events (Continued)
Amendment to the Articles of Incorporation
On April 13, 2016, the Company amended and restated its articles of incorporation to increase the number of shares which the
Company shall have the authority to issue to 50,000,000 shares of Common Stock, par value $0.0001 and 45,000,000 shares of Preferred Stock, $0.0001 par value.
Employment agreements
On April 13, 2016 the Company entered into a contingent employment agreement for the positions of the Chairman and Chief
Executive Officer ("CEO") and the Chief Medical Officer, Executive Vice President Research & Development ("CMO"). The employment agreements are contingent on the closing of the Merger
Agreement. Under the terms of the agreement the CEO will receive a base salary of $400,000 plus bonus potential up to 50% of the base salary based upon the achievement of certain corporate targets. In
addition, the CEO will receive restricted stock awards representing 1.25% of the issued and outstanding common stock of the Company and nonqualified stock option to purchase an additional 2.5% of the
issued and outstanding stock of the Company both calculated on a fully-diluted basis. Under the terms of the agreement the CMO will receive a base salary of $370,000 plus bonus potential up to 40% of
the base salary based upon the achievement of certain corporate targets. In addition, the CMO will receive restricted stock awards representing 0.25% of the issued and outstanding common stock of the
Company and nonqualified stock option to purchase an additional 1.25% of the issued and outstanding stock of the Company both calculated on a fully-diluted basis. Restricted stock awards and
nonqualified stock awards for both executives will vest 25% on the completion of the Merger Agreement and 25% at each of the first, second and third anniversary date of the Merger Agreement.
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Annex A
Execution Version
AGREEMENT AND PLAN OF MERGER
AND REORGANIZATION
among:
SYNTA PHARMACEUTICALS CORP.,
a Delaware corporation;
SAFFRON MERGER SUB, INC.
a Delaware
corporation; and
MADRIGAL PHARMACEUTICALS, INC.
a Delaware corporation
Dated as of April 13, 2016
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AGREEMENT AND PLAN OF MERGER AND REORGANIZATION
THIS AGREEMENT AND PLAN OF MERGER AND REORGANIZATION
(this
"
Agreement
") is made and entered into as of April 13, 2016, by and among Synta Pharmaceuticals Corp., a Delaware corporation
("
Saffron
"); Saffron Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Saffron ("
Merger
Sub
"); and Madrigal Pharmaceuticals, Inc., a Delaware corporation (the "
Company
"). Certain capitalized terms used in this
Agreement are defined in
Exhibit A
.
RECITALS
A. Saffron
and the Company intend to merge Merger Sub with and into the Company (the "
Merger
") in accordance with this
Agreement and the DGCL. Upon consummation of the Merger, Merger Sub will cease to exist, and the Company will become a wholly-owned subsidiary of Saffron.
B. For
U.S. federal income tax purposes, Saffron, Merger Sub and the Company intend that the Merger, together with the issuance of shares of Saffron Common Stock to the
stockholders of the Company, will qualify as a "reorganization" within the meaning of Section 368(a) of the Code, that this Agreement will constitute a "plan of reorganization" for purposes of
Section 354 and 361 of the Code, and that Saffron, Merger Sub and the Company will each be a "party to the reorganization" within the meaning of Section 368(b) of the Code.
C. The
Board of Directors of Saffron by unanimous vote of all directors participating in the vote has (i) determined that the Merger is advisable and in the best
interests of Saffron and its stockholders, (ii) approved this Agreement, the Merger, the issuance of shares of Saffron Common Stock to the stockholders of the Company pursuant to the terms of
this Agreement, and the other actions contemplated by this Agreement and has deemed this Agreement advisable and (iii) determined to recommend that the stockholders of Saffron vote to approve
the issuance of shares of Saffron Common Stock to the stockholders of the Company pursuant to the terms of this Agreement, and such other actions as contemplated by this Agreement.
D. The
Board of Directors of Merger Sub has unanimously (i) determined that the Merger is advisable and in the best interests of Merger Sub and its sole stockholder,
(ii) approved this Agreement, the Merger, and the other actions contemplated by this Agreement and has deemed this Agreement advisable and (iii) determined to recommend that the
stockholder of Merger Sub vote to approve the Merger and such other actions as contemplated by this Agreement.
E. The
Board of Directors of the Company has unanimously (i) determined that the Merger is advisable and in the best interests of the Company and its stockholders,
(ii) has approved this Agreement, the Merger and the other actions contemplated by this Agreement and has deemed this Agreement advisable and (iii) approved and determined to recommend
the approval and adoption of this Agreement and the approval of the Merger to the stockholders of the Company.
F. In
order to induce Saffron and Merger Sub to enter into this Agreement and to cause the Merger to be consummated, the Company has entered into a definitive agreement with
certain investors irrevocably committing such investors to complete a private placement of convertible notes of the Company raising an aggregate of $9,000,000 of gross proceeds for the Company in
multiple tranches, including a tranche of $750,000 of gross proceeds received by the Company on March 1, 2016 and a tranche of $2,625,000 of gross proceeds to be received by the Company
concurrently with or prior to the signing of this Agreement (the "
Company Private Placement
").
G. In
order to induce the Company to enter into this Agreement and to cause the Merger to be consummated, certain stockholders of Saffron listed on
Schedule I-A
hereto, are executing voting agreements in
favor of the Company concurrently with the execution and delivery of this Agreement in
the form substantially attached hereto as
Exhibit B
(the "
Saffron Voting Agreements
").
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H. In
order to induce Saffron and Merger Sub to enter into this Agreement and to cause the Merger to be consummated, certain stockholders of the Company listed on
Schedule I-B
hereto, are executing
voting agreements in favor of Saffron concurrently with the execution and delivery of this Agreement in
substantially the form attached hereto as
Exhibit C
(the "
Company Voting Agreements
" and,
together with the Saffron Voting Agreements, the "
Voting Agreements
").
I. In
order to induce Saffron and Merger Sub to cause the Merger to be consummated, each of the Company's executive officers, directors and holders of shares of Company
Capital Stock listed on
Schedule I-C
will execute lock-up agreements in favor of Saffron prior to the Closing relating to sales and certain other
dispositions of shares of Saffron Common Stock or certain other securities in substantially the form attached hereto as
Exhibit D
(the
"
Lock-up Agreements
").
AGREEMENT
The parties to this Agreement, intending to be legally bound, agree as follows:
Section 1. DESCRIPTION OF TRANSACTION
1.1 Structure of the Merger
.
Upon the terms and subject to the conditions set forth in this Agreement, at the Effective Time (as defined in
Section 1.3
), Merger
Sub shall be merged with and into the Company, and the separate existence of Merger Sub shall cease. The Company will continue as the surviving corporation in the Merger (the
"
Surviving Corporation
").
1.2 Effects of the Merger
.
The Merger shall have the effects set forth in this Agreement and in the applicable provisions of the DGCL. As a result of the Merger, the Company will become a wholly-owned subsidiary
of Saffron.
1.3 Closing; Effective Time
.
Unless this Agreement is earlier terminated pursuant to the provisions of
Section 9.1
of this Agreement, and subject to the
satisfaction or waiver of the conditions set forth in
Section 6
,
Section 7
and
Section 8
of
this Agreement, the consummation of the Merger (the "
Closing
") shall take place at
the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Center, Boston, MA 02111, as promptly as practicable (but in no event later than the second Business Day following the
satisfaction or waiver of the last to be satisfied or waived of the conditions set forth in
Section 6
,
Section 7
and
Section 8
, other than those conditions that by their nature are to be
satisfied at the Closing, but subject to the satisfaction or waiver of each of such conditions), or at such other time, date and place as Saffron and the Company may mutually agree in writing,
provided
that if all the conditions set forth in
Section 6
,
Section 7
and
Section 8
shall not have
been satisfied or waived on such second Business
Day, then the Closing shall take place on the first subsequent Business Day on which all such conditions shall have been satisfied or waived. The date on which the Closing actually takes place is
referred to as the "
Closing Date
." At the Closing, the Parties hereto shall cause the Merger to be consummated by executing and filing with the
Secretary of State of the State of Delaware a Certificate of Merger with respect to the Merger, satisfying the applicable requirements of the DGCL and in a form reasonably acceptable to Saffron and
the Company. The Merger shall become effective at the time of the filing of such Certificate of Merger with the Secretary of State of the State of Delaware (the "
Certificate of
Merger
"), or at such later time as may be specified in such Certificate of Merger with the consent of Saffron and the Company (the time as of which the Merger becomes effective
being referred to as the "
Effective Time
").
1.4 Certificate of Incorporation and Bylaws; Directors and Officers.
At
the Effective Time:
(a) the
Certificate of Incorporation of the Company shall be amended and restated in its entirety to read as set forth on
Exhibit E
, and as so amended and restated, shall be the Certificate of
Incorporation of the Surviving Corporation, until thereafter amended as
provided by the DGCL and such Certificate of Incorporation;
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(b) the
Certificate of Incorporation of Saffron shall be the Saffron Charter immediately prior to the Effective Time, until thereafter amended as provided by the DGCL and
such Certificate of Incorporation;
provided
,
however
, that at the Effective Time, Saffron shall file an
amendment to its certificate of incorporation to change the name of Saffron to "Madrigal Pharmaceuticals, Inc.";
(c) the
Bylaws of the Company shall be amended and restated in their entirety to read identically to the Bylaws of Merger Sub as in effect immediately prior to the Effective
Time, and as so amended and restated, shall be the Bylaws of the Surviving Corporation until thereafter amended as provided by the DGCL and such Bylaws;
(d) the
directors and officers of Saffron shall be as set forth in
Section 5.11
; and
(e) the
directors and officers of the Surviving Corporation, each to hold office in accordance with the Certificate of Incorporation and Bylaws of the Surviving Corporation,
shall be the directors and officers of Saffron as set forth in
Section 5.11
.
1.5 Conversion of Shares.
(a) At
the Effective Time, by virtue of the Merger and without any further action on the part of Saffron, Merger Sub, the Company or any stockholder of the Company:
(i) any
shares of Company Common Stock or Company Preferred Stock held as treasury stock prior to the Effective Time shall be canceled and retired and shall cease to exist,
and no consideration shall be delivered in exchange therefor; and
(ii) subject
to
Section 1.5(c)
, each share of Company Common Stock outstanding immediately prior to the Effective Time
(excluding shares to be canceled pursuant to
Section 1.5(a)(i)
and excluding Dissenting Shares) shall be converted solely into the right to
receive a number of shares of Saffron Common Stock equal to the Exchange Ratio (the "
Merger Shares
").
(b) If
any shares of Company Common Stock outstanding immediately prior to the Effective Time are unvested or are subject to a repurchase option or the risk of forfeiture or
under any applicable restricted stock purchase agreement or other agreement with the Company (other than those shares (if any) which, as a result of the Merger, shall, by the terms of the agreements
applicable thereto, vest or for which any such repurchase options or other such restrictions or risks of forfeiture shall lapse), then the shares of Saffron Common Stock issued in exchange for such
shares of Company Common Stock will to the same extent be unvested and subject to the same repurchase option or risk of forfeiture, and the certificates representing such shares of Saffron Common
Stock shall accordingly be marked with appropriate legends. The Company shall take all action that may be necessary to ensure that, from and after the Effective Time, Saffron is entitled to exercise
any such repurchase option or other right set forth in any such restricted stock purchase agreement or other agreement in accordance with its terms.
(c) No
fractional shares of Saffron Common Stock shall be issued in connection with the Merger as a result of the conversion provided for in
Section 1.5(a)(ii)
, and no certificates or scrip for any such
fractional shares shall be issued. Any holder of Company Common Stock who would
otherwise be entitled to receive a fraction of a share of Saffron Common Stock (after aggregating all fractional shares of Saffron Common Stock issuable to such holder) shall, in lieu of such fraction
of a share and upon surrender of such holder's Company Stock Certificate(s) (as defined in
Section 1.6
), be entitled to receive, from Saffron in
accordance with the provisions of this
Section 1.5
, in lieu of such fractional shares and upon surrender of such Company Stock Certificate(s), a
cash payment rounded up to the nearest cent in an amount determined by multiplying (i) the closing price per share of Saffron Common Stock on the NASDAQ Global Market (or such other NASDAQ
market on which the Saffron Common Stock then trades), as reported in
The Wall Street Journal
(or, if not reported thereby, as reported in another
authoritative source), on the Closing Date by (ii) the fraction of a share of Saffron Common Stock (after aggregating all shares represented by Company Stock Certificates
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delivered
by such holder rounded up to the nearest one thousandth when expressed in decimal form) to which such holder would otherwise be entitled (the "
Fractional Share Cash
Amount
"). The Parties acknowledge that payment of the Fractional Share Cash Amount was not separately bargained-for consideration but merely represents a mechanical rounding
off for purposes of avoiding the expense and inconvenience to Saffron that would otherwise be caused by the issuance of fractional shares.
(d) Each
share of Common Stock, $0.0001 par value per share, of Merger Sub issued and outstanding immediately prior to the Effective Time shall be converted into and
exchanged for one validly issued, fully paid and nonassessable share of Common Stock, $0.0001 par value per share, of the Surviving Corporation. Each stock certificate of Merger Sub evidencing
ownership of any such shares shall, as of the Effective Time, evidence ownership of such shares of Common Stock of the Surviving Corporation.
(e) If,
between the date of this Agreement and the Effective Time, the outstanding shares of Company Capital Stock or Saffron Common Stock shall have been changed into, or
exchanged for, a different number of shares or a different class, by reason of any stock dividend, subdivision, reclassification, recapitalization, split, combination or exchange of shares, the
Exchange Ratio shall be correspondingly adjusted to provide the holders of Company Common Stock and Company Preferred Stock the same economic effect as contemplated by this Agreement prior to such
event.
(f) The
certificates representing shares of Saffron Common Stock issuable in the Merger hereunder, or any other securities issued in respect of such shares upon any stock
split, stock dividend, recapitalization, merger, consolidation or similar event, shall bear the following legends (along with any other legends that may be required under applicable state and federal
corporate and securities laws):
THE
SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR UNDER STATE SECURITIES LAWS AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT
WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE, DISTRIBUTION OR OTHER TRANSFER, PLEDGE OR HYPOTHECATION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION
STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL SATISFACTORY TO THE ISSUER THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933 OR APPLICABLE STATE SECURITIES LAWS.
1.6 Closing of the Company's Transfer Books
.
At the Effective Time, the stock transfer books of the Company shall be closed with respect to all shares of Company Common Stock and Company Preferred Stock outstanding immediately
prior to the Effective Time. No further transfer of any such shares of Company Common Stock or Company Preferred Stock shall be made on such stock transfer books after the Effective Time. If, after
the Effective Time, a valid certificate previously representing any shares of Company Common Stock or Company Preferred Stock outstanding immediately prior to the Effective Time (a
"
Company Stock Certificate
") is presented to Saffron or the Surviving Corporation, such Company Stock Certificate shall be canceled and shall be
exchanged as provided in
Sections 1.5
and
1.7
.
1.7 Surrender of Certificates.
(a) Promptly
after the Effective Time (and in any event within three (3) Business Days thereafter), Saffron shall mail to the Persons who were record holders of
Company Stock Certificates immediately prior to the Effective Time: (i) a letter of transmittal in customary form and containing such provisions as Saffron and the Company shall reasonably
agree (including (A) a provision confirming that delivery of Company Stock Certificates shall be effected, and risk of loss and title to Company Stock Certificates shall pass, only upon
delivery of such Company Stock Certificates to Saffron and (B) a general release of all claims against the Company and Saffron); and (ii) instructions
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for
use in effecting the surrender of Company Stock Certificates in exchange for certificates representing Saffron Common Stock and the Fractional Share Cash Amount. Upon surrender of a Company Stock
Certificate to Saffron for exchange, together with a duly executed letter of transmittal and such other documents as may be reasonably required by Saffron: (A) the holder of such Company Stock
Certificate shall be entitled to receive in exchange therefor a certificate representing the number of whole shares of Saffron Common Stock that such holder has the right to receive (and the
Fractional Share Cash Amount) pursuant to the provisions of
Section 1.5
; and (B) the Company Stock Certificate so surrendered shall be
canceled. Until surrendered as contemplated by this
Section 1.7(b)
, each Company Stock Certificate shall be deemed, from and after the Effective
Time, to represent only the right to receive shares of Saffron Common Stock (and the Fractional Share Cash Amount). If any Company Stock Certificate shall have been lost, stolen or destroyed, Saffron
may, in its discretion and as a condition precedent to the delivery of any shares of Saffron Common Stock, require the owner of such lost, stolen or destroyed Company Stock Certificate to provide an
applicable affidavit with respect to such Company Stock Certificate and post a bond indemnifying Saffron against any claim suffered by Saffron related to the lost, stolen or destroyed Company Stock
Certificate or any Saffron Common Stock issued in exchange therefor as Saffron may reasonably request. If any certificates evidencing shares of Saffron Common Stock are to be issued in a name other
than that in which the surrendered Company Stock Certificate is registered, it shall be a condition of the issuance thereof that the Company Stock Certificate so surrendered shall be properly endorsed
or accompanied by an executed form of assignment separate from the Company Stock Certificate and otherwise in proper form for transfer, and that the Person requesting such exchange pay to Saffron any
transfer or other tax required by reason of the issuance of a new certificate for shares of Saffron Common Stock in any name other than that of the registered holder of the Company Stock Certificate
surrendered or otherwise establish to the satisfaction of Saffron that such tax has been paid or is not payable.
(b) No
dividends or other distributions declared or made with respect to Saffron Common Stock with a record date after the Effective Time shall be paid to the holder of any
unsurrendered Company Stock Certificate with respect to the shares of Saffron Common Stock that such holder has the right to receive in the Merger until such holder surrenders such Company Stock
Certificate (or complies with the lost stock provisions) in accordance with this
Section 1.7
(at which time such holder shall be entitled,
subject to the effect of applicable abandoned property, escheat or similar Laws, to receive all such dividends and distributions, without interest).
(c) Each
of Saffron, Merger Sub, the Company and the Surviving Corporation shall be entitled to deduct and withhold, from any consideration payable or otherwise deliverable
under this Agreement to any holder of record of any Company Capital Stock immediately prior to the Effective Time or any other Person who is entitled to receive merger consideration pursuant to this
Agreement, such amounts as are required to be withheld or deducted under the Code or any other state, local or foreign Tax Law with respect to the making of such payment and shall be entitled to
request any reasonably appropriate Tax forms, including Form W-9 (or the appropriate Form W-8, as applicable) from any recipient of merger consideration hereunder. To the extent that
amounts are so withheld or deducted, such withheld or deducted amounts shall be treated for all purposes of this Agreement as having been paid to the Person(s) to whom such amounts would otherwise
have been paid.
(d) No
party to this Agreement shall be liable to any holder of any Company Stock Certificate or to any other Person with respect to any shares of Saffron Common Stock (or
dividends or distributions with respect thereto) or for any cash amounts, delivered to any public official pursuant to any applicable abandoned property Law, escheat Law or similar Law.
1.8 Appraisal Rights.
(a) Notwithstanding
any provision of this Agreement to the contrary, shares of Company Capital Stock that are outstanding immediately prior to the Effective Time and which
are held by stockholders
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who
have exercised and perfected appraisal rights or dissenters' rights for such shares of Company Capital Stock in accordance with the DGCL (collectively, the "
Dissenting
Shares
") shall not be converted into or represent the right to receive the per share amount of the merger consideration described in
Section 1.5
attributable to such
Dissenting Shares. Such stockholders shall be entitled to receive payment of the appraised value of such shares
of Company Capital Stock held by them in accordance with the DGCL, unless and until such stockholders fail to perfect or effectively withdraw or otherwise lose their appraisal rights under the DGCL.
All Dissenting Shares held by stockholders who shall have failed to perfect or who effectively shall have withdrawn or lost their right to appraisal of such shares of Company Capital Stock under the
DGCL shall thereupon be deemed to be converted into and to have become exchangeable for, as of the Effective Time, the right to receive the per share amount of the merger consideration attributable to
such Dissenting Shares upon their surrender in the manner provided in
Section 1.7
.
(b) The
Company shall give Saffron prompt written notice of any demands by dissenting stockholders received by the Company, withdrawals of such demands and any other
instruments served on the Company and any material correspondence received by the Company in connection with such demands and Saffron shall have the right to participate in all negotiations and
proceedings with respect to such demands. Except with the prior written consent of Saffron, or to the extent required by applicable law, the Company shall not make any payment with respect to, or
offer to settle or settle, any such demands.
1.9 Further Action
.
If, at any time after the Effective Time, any further action is determined by the Surviving Corporation to be necessary or desirable to carry out the purposes of this Agreement or to
vest the Surviving Corporation with full right, title and possession of and to all rights and property of the Company, then the officers and directors of the Surviving Corporation shall be fully
authorized, and shall use their commercially reasonable efforts (in the name of the Company, in the name of Merger Sub and otherwise) to take such action.
Section 2. REPRESENTATIONS AND WARRANTIES OF THE COMPANY
The
Company represents and warrants to Saffron and Merger Sub as follows, except as set forth in the written disclosure schedule delivered by the Company to Saffron (the
"
Company Disclosure Schedule
"). The Company Disclosure Schedule shall be arranged in parts and subparts corresponding to the numbered and lettered
Sections and subsections contained in this
Section 2
. The disclosures in any part or subpart of the Company Disclosure Schedule shall qualify
other Sections and subsections in this
Section 2
only to the extent it is clear from the face of the disclosure that such disclosure is
applicable to such other Sections and subsections.
2.1 Organization.
(a) The
Company is a corporation, duly organized, validly existing and in good corporate standing under the Laws of the State of Delaware. The Company has all requisite
corporate power and authority to own, lease and operate all of its properties and assets and to carry on its business as it is now being conducted. The Company is duly licensed or qualified to do
business and is in corporate good standing in each jurisdiction in which the nature of the business conducted by it or the character or location of the properties and assets owned, leased, or operated
by it makes such licensing or qualification necessary, except where the failure to be so licensed or qualified and in corporate good standing would not, either individually or in the aggregate,
reasonably be expected to have a Company Material Adverse Effect. The certificate of incorporation of the Company (the "
Company Charter
") and the bylaws
of the Company (the "
Company Bylaws
"), copies of which have previously been made available to Saffron, are true, correct and complete copies of such
documents as currently in effect and the Company is not in violation of any provision thereof. Other than the Company Charter and the Company Bylaws, the Company is not a party to or bound by or
subject to any stockholder agreement
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or
other agreement governing the affairs of the Company or the relationships, rights and duties of stockholders and is not subject to a stockholder rights plan or similar plan.
(b) The
Company does not have, and has never had, any Subsidiaries.
2.2 Capitalization.
(a) The
authorized capital stock of the Company consists of 50,000,000 shares of Company Common Stock and 45,000,000 shares Company Preferred Stock. As of the date hereof,
there are 1,105,820 shares of Company Common Stock issued and outstanding (of which 60,820 are shares of restricted stock of the Company) and no shares of Company Preferred Stock issued and
outstanding. As of the date hereof, there are no shares of Company Common Stock and no shares of Company Preferred Stock held in the treasury of the Company. As of the date hereof, there is
$39,511,280 aggregate principal amount of Convertible Debt outstanding, which is convertible into an aggregate of 39,273,451 shares of Company Common Stock. The Company has no shares of Company Common
Stock or Company Preferred Stock reserved for issuance other than as described above. The outstanding shares of Company Common Stock and Company Preferred Stock have been duly authorized and are
validly issued, fully paid and nonassessable, and were not issued in violation of the material terms of any agreement or understanding binding upon the Company at the time at which they were issued
and were issued in compliance with the Company Charter and Company Bylaws and all applicable Laws. The Company does not have and is not bound by any outstanding subscriptions, options, warrants,
calls, commitments, rights agreements, or agreements of any character calling for the Company to issue, deliver, or sell, or cause to be issued, delivered, or sold any shares of Company Common Stock
or any other equity security of the Company or any securities convertible into, exchangeable for, or representing the right to subscribe for, purchase, or otherwise receive any shares of Company
Common Stock or any other equity security of the Company or obligating the Company to grant, extend, or enter into any such subscriptions, options, warrants, calls, commitments, rights agreements, or
any other similar agreements. There are no registration rights, repurchase or redemption rights, anti-dilutive rights, voting agreements, voting trusts, preemptive rights or restrictions on transfer
relating to any capital stock of the Company.
Section 2.2(a)
of the Company Disclosure Schedule sets forth the pro forma capitalization of
Saffron following the Merger.
(b)
Section 2.2(b)
of the Company Disclosure Schedule sets forth a true, correct and complete list, as of the date
hereof, of all issued and outstanding shares of Company Common Stock and shares of Company Preferred Stock, on a holder-by-holder basis.
(c) The
Company does not have any equity compensation plans or any individual compensation arrangements with respect to Company Common Stock. To the extent the Company ever
had any such arrangements outstanding,
Section 2.2(c)
of the Company Disclosure Schedule lists such arrangements and provides evidence of the
termination of such arrangements, including releases.
2.3 Authority
. The Company has all requisite corporate power and authority to
execute and deliver this Agreement and to consummate the Contemplated Transactions and perform its respective obligations hereunder, subject only to obtaining the Company Stockholder Approval. The
adoption, execution, delivery and performance of this Agreement and the approval of the consummation of the Contemplated Transactions have been recommended by, and have been duly and validly adopted
and approved by a unanimous vote of, the Board of Directors of the Company. No other approval or consent of, or action by, the holders of the outstanding securities of the Company, other than the
Company Stockholder Approval, is required in order for the Company to execute and deliver this Agreement and to consummate the Contemplated Transactions and perform its obligations hereunder. The
Board of Directors of the Company has declared this Agreement advisable, has directed that this Agreement be submitted to the Company Stockholders for adoption and approval and has recommended that
the Company Stockholders adopt and approve this Agreement. Except for the Company Stockholder Approval and the filing of the Certificate of Merger with the Secretary of State
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of
the State of Delaware, no other corporate proceeding on the part of the Company is necessary to authorize the adoption, execution, delivery and performance of this Agreement or to consummate the
Merger and the other Contemplated Transactions. This Agreement has been duly and validly executed and delivered by the Company and (assuming due authorization, execution and delivery by the other
parties hereto), constitutes the legal, valid and binding obligations of the Company, enforceable against the Company in accordance with its terms, subject to applicable bankruptcy, insolvency,
reorganization, moratorium, or other similar Laws relating to creditors' rights and general principles of equity. All other documents required to be executed by the Company on or prior to the date
hereof in connection with the Contemplated Transactions have been duly and validly executed and delivered by the Company and (assuming due authorization, execution and delivery by the other parties
thereto) constitute the legal, valid and binding obligations of the Company, enforceable against the Company in accordance with their respective terms, subject to applicable bankruptcy, insolvency,
reorganization, moratorium, or other similar Laws relating to creditors' rights and general principles of equity.
2.4 Non-Contravention; Consents.
(a) Except
as set forth in
Section 2.4(a)
of the Company Disclosure Schedule, the execution and delivery of this
Agreement by the Company does not, and the consummation by the Company of the Contemplated Transactions will not, (i) conflict with, or result in any violation or breach of, any provision of
the Company Charter or the Company Bylaws, (ii) conflict with, or result in any violation or breach of, or constitute (with or without notice or lapse of time, or both) a default (or give rise
to a right of termination, cancellation or acceleration of any obligation or loss of any material benefit) under, require a consent or waiver under, constitute a change in control under, require the
payment of a penalty under or result in the imposition of any Encumbrance on the Company's assets under, any of the terms, conditions or provisions of any Company Material Contract or other agreement,
instrument or obligation to which the Company is a party or by which it or any of its properties or assets may be bound, or (iii) subject to obtaining the Company Stockholder Approval and
subject to the consents, approvals and authorizations specified in clauses (i) through (v) of
Section 2.4(b)
having been obtained
prior to the Effective Time and all filings and notifications described in
Section 2.4(b)
having been made, conflict with or violate any Law
applicable to the Company or any of its properties or assets, except in the case of clause (iii) of this
Section 2.4(a)
for any such
conflicts or violations, that have not had, and would not reasonably be expected to result in, a Company Material Adverse Effect.
(b) No
consent, approval, license, permit, order or authorization of, or registration, declaration, notice or filing with, any Governmental Authority is required by or with
respect to the Company in connection with the execution and delivery of this Agreement by the Company or the consummation by the Company of the Contemplated Transactions, except for
(i) obtaining the Company Stockholder Approval, (ii) the filing of the Certificate of Merger with the Delaware Secretary of State and appropriate corresponding documents with the
appropriate authorities of other states in which the Company is qualified as a foreign corporation to transact business, (iii) any filings required to be made with the SEC in connection with
this Agreement and the Contemplated Transactions (including (A) the filing of the Proxy Statement with the SEC in accordance with the Exchange Act and (B) the filing of a Form D
Notice of Exempt Offering of Securities or other related filings in reliance on an exemption provided in Regulation D of the Securities Act), (iv) such consents, approvals, orders,
authorizations, registrations, declarations, notices and filings as may be required under applicable state securities Laws, the rules and regulations of the NASDAQ Global Market, and (v) such
other consents, licenses, permits, orders, authorizations, filings, approvals and registrations which, if not obtained or made, have not had, and would not reasonably be expected to result in, a
Company Material Adverse Effect.
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2.5 Financial Statements.
(a)
Section 2.5(a)
of the Company Disclosure Schedule includes true and complete copies of the Company's consolidated
balance sheet as of December 31, 2015 and December 31, 2014, and the related consolidated statements of operations, cash flows and stockholders equity for the twelve months ended
December 31, 2015 and December 31, 2014, together with the notes thereto (collectively, the "
Company Preliminary Financial Statements
").
The Company Preliminary Financial Statements (i) complied, or will comply as to form in all material respects prior to the filing of the Proxy Statement, with the published rules and
regulations of the SEC with respect thereto, (ii) were prepared in accordance with GAAP applied on a consistent basis (unless otherwise noted therein) throughout the periods indicated and
(iii) fairly present, in all material respects, the financial condition and operating results of the Company as of the dates and for the periods indicated therein. The balance sheet of the
Company as of December 31, 2015 included in
Section 2.5(a)
of the Company Disclosure Schedule is hereinafter referred to as the
"
Company Balance Sheet
."
(b) The
Company maintains adequate disclosure controls and procedures designed to ensure that material information relating to the Company is made known to the Chief
Executive Officer or President and the Chief Financial Officer of the Company by others within those entities.
(c) None
of the Company or, to the Knowledge of the Company, any director, officer, employee, or internal or external auditor of the Company has received or otherwise had or
obtained actual knowledge of any substantive material complaint, allegation, assertion or claim, whether written or oral, that the Company has engaged in questionable accounting or auditing practices.
(d) The
Company maintains a system of internal accounting controls designed to provide reasonable assurance that: (i) transactions are executed in accordance with
management's general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset
accountability; (iii) access to assets is permitted only in accordance with management's general or specific authorization; and (iv) the recorded accountability for assets is compared
with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences;
provided
,
however
, that the Company has
not adopted or conducted an evaluation of compliance of the Company's internal accounting controls with, the Internal
Control Framework developed by the Committee of Sponsoring Organizations of the Treadway Commission. Since January 1, 2014, the Company has maintained internal control over financial reporting
that provides reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP and there have been no
instances of fraud, whether or not material, involving the management of the Company or other employees of the Company who have a significant role in the internal control over financial reporting of
the Company.
2.6 Absence of Changes
.
Since the date of the Company Balance Sheet, the Company has conducted its businesses in all material respects in the Ordinary Course of Business consistent with its past practices.
Except as set forth on
Section 2.6
of the Company Disclosure Schedule, after the date of the Company Balance Sheet and on or before the date
hereof:
(a) there
has not been any change, event, circumstance or condition to the Knowledge of the Company that, individually or in the aggregate, has had, or would reasonably be
expected to have, a Company Material Adverse Effect;
(b) there
has been no split, combination or reclassification of any of the outstanding shares of the capital stock of the Company, and the Company has not declared or paid
any dividends on or made any other distributions (in either case, in stock or property) on or in respect of the outstanding shares of the capital stock of the Company;
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(c) the
Company has not allotted, reserved, set aside or issued, authorized or proposed the allotment, reservation, setting aside or issuance of, or purchased or redeemed or
proposed the purchase or redemption of, any shares in its capital stock or any class of securities convertible or exchangeable into, or rights, warrants or options to acquire, any such shares or other
convertible or exchangeable securities;
(d) except
as required as a result of a change in applicable Laws or GAAP, there has not been any material change in any method of accounting or accounting practice by the
Company;
(e) the
Company has not (i) acquired or sold, pledged, leased, encumbered or otherwise disposed of any material property or assets or agreed to do any of the
foregoing or (ii) incurred or committed to incur capital expenditures in excess of $100,000, in the aggregate;
(f) there
has been no transfer (by way of a license or otherwise) of, or agreement to transfer to, any Person's rights to any of the Company Intellectual Property;
(g) there
has been no notice delivered to the Company of any claim of ownership by a third party of any of the Company Intellectual Property owned or developed by the
Company, or of infringement by the Company of any Third Party Intellectual Property;
(h) there
has not been any: (i) grant of any severance or termination pay to any employee of the Company; (ii) entry into any employment, deferred
compensation, severance or other similar plan or agreement (or any amendment to any such existing agreement) with any new or current employee of the Company; (iii) change in the compensation,
bonus or other benefits payable or to become payable to its directors, officers, employees or consultants, except in the Ordinary Course of Business consistent with past practice, or as required by
any pre-existing plan or arrangement set forth in
Section 2.6
of the Company Disclosure Schedule; or (iv) termination of any of the
officers or key employees of the Company; and
(i) there
has not been any agreement to do any of the foregoing.
2.7 Title to Assets
.
The Company owns, and has good and valid title to, or, in the case of leased properties and assets, valid leasehold interests in, all tangible properties or assets and equipment used or
held for use in its business or operations or purported to be owned by it. All of said assets are owned by the Company free and clear of any Encumbrances, except for: (i) any lien for current
Taxes not yet due and payable or for Taxes that are being contested in good faith and for which adequate reserves have been made on the Company Balance Sheet; (ii) minor liens that have arisen in the
Ordinary Course of Business and that do not (in any case or in the aggregate) materially detract from the value of the assets subject thereto or materially impair the operations of the Company; and
(iii) Encumbrances described in
Section 2.7
of the Company Disclosure Schedule.
2.8 Properties.
(a)
Section 2.8(a)
of the Company Disclosure Schedule identifies (x) the street address of each parcel of
Company Leased Real Property, (y) the identification of the Company Lease and the Company Ancillary Lease Documents and (z) the identity of the lessor, lessee and current occupant (if
different than the lessee) of each such parcel of Company Leased Real Property. With respect to each Company Lease, except as would not, individually or in the aggregate, have a Company Material
Adverse Effect:
(i) the
Company Leases and the Company Ancillary Lease Documents are valid, binding and, subject to applicable bankruptcy, insolvency, reorganization, moratorium or other
similar Laws relating to creditors' rights and general principles of equity, enforceable and in full force and effect and have not been modified or amended, and the Company holds a valid and existing
leasehold interest under such Company Leases free and clear of any Encumbrances except Permitted Encumbrances. The Company has delivered to Saffron full, complete and accurate copies of each
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of
the Company Leases and all Company Ancillary Lease Documents described in
Section 2.8(a)(i)
of the Company Disclosure Schedule;
(ii) none
of the Company Leased Real Property is subject to any Encumbrance other than a Permitted Encumbrance;
(iii) the
Company Leases and all Company Ancillary Lease Documents shall continue to be legal, valid, binding, enforceable and in full force and effect on identical terms
following the Closing;
(iv) with
respect to each of the Company Leases, the Company has not exercised or given any notice of exercise, nor has any lessor or landlord exercised or received any
notice of exercise, of any option, right of first offer or right of first refusal contained in any such Company Lease or Company Ancillary Lease Document, including any such option or right pertaining
to purchase, expansion, renewal, extension or relocation;
(v) none
of the Company, nor, to the Knowledge of the Company, any other party to any Company Leases or Company Ancillary Lease Documents is in breach or default, and, to
the Knowledge of the Company, no event has occurred which, with notice or lapse of time, would constitute such a breach or default or permit termination, modification or acceleration under the Company
Leases or any Company Ancillary Lease Documents;
(vi) no
party to the Company Leases has repudiated any provision thereof and there are no disputes, oral agreements or forbearance programs in effect as to the Company
Leases; and
(vii) the
Company has not assigned, transferred, conveyed, mortgaged, deeded in trust or encumbered any of its rights and interest in the leasehold or subleasehold under any
of the Company Leases or any Company Ancillary Lease Documents.
(b) The
Company owns good title, free and clear of all Encumbrances, to all personal property and other non-real estate assets, in all cases excluding the Company
Intellectual Property, necessary to conduct the Company Business, except for Permitted Encumbrances. The Company, as lessee, has the right under valid and subsisting leases to use, possess and control
all personal property leased by the Company as now used, possessed and controlled by the Company.
(c) The
Company Leased Real Property constitutes all of the real property used or occupied by the Company in connection with the conduct of the Company Business.
(d) The
Company does not have any Company Owned Real Property, nor is the Company a party to or bound by or subject to any agreement, contract or commitment, or any option
to purchase, any real or immovable property.
2.9 Intellectual Property.
(a)
Section 2.9(a)
of the Company Disclosure Schedule contains a complete and accurate list of all (i) Patents
owned by the Company or used or held for use by the Company in the Company Business ("
Company Patents
"), registered and material unregistered Marks
owned by the Company or used or held for use by the Company in the Company Business ("
Company Marks
") and registered and material unregistered
Copyrights owned by the Company or used or held for use by the Company in the Company Business ("
Company Copyrights
"), (ii) licenses, sublicenses
or other agreements under which the Company is granted rights by others in the Company Intellectual Property ("
Company Licenses-In
") (other than
commercial off the shelf software or materials transfer agreements), and (iii) licenses, sublicenses or other agreements under which the Company has granted rights to others in the Company
Intellectual Property ("
Company Licenses-Out
").
(b) With
respect to the Company Intellectual Property (i) purported to be owned by the Company, the Company exclusively owns such Company Intellectual Property and
(ii) licensed to the
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Company
by a third party (other than commercial off the shelf software or materials transfer agreements), such Company Intellectual Property are the subject of a written license or other agreement; in
the case of the foregoing clauses (i) and (ii) above, free and clear of all Encumbrances, other than Encumbrances resulting from the express terms of a Company License-In or Company
License-Out or Permitted Encumbrances granted by the Company.
(c) All
Company Intellectual Property owned by, and, to the Knowledge of the Company, all Company Intellectual Property exclusively licensed to the Company that have been
issued by, or registered with, or are the subject of an application filed with, as applicable, the U.S. Patent and Trademark Office, the U.S. Copyright Office or any similar office or agency anywhere
in the world are currently in compliance with formal legal requirements (including without limitation, as applicable, payment of filing, examination and maintenance fees, inventor declarations, proofs
of working or use, timely post-registration filing of affidavits of use and renewal applications), and, to the Knowledge of the Company, all Company Patents, Company Marks and Company Copyrights, and
all intellectual property rights and/or proprietary rights relating to any of the foregoing, that are owned by or exclusively licensed to the Company are valid and enforceable.
(d) To
the Knowledge of the Company, each Company Patent that has been issued by, or registered with, or is the subject of an application filed with, as applicable, the U.S.
Patent and Trademark Office or any similar office or agency anywhere in the world was issued, registered, or filed, as applicable, with the correct inventorship and there has been no known misjoinder
or nonjoinder of inventors.
(e) No
Company Patent is now involved in any interference, reissue, re-examination or opposition proceeding; to the Knowledge of the Company, there is no patent or patent
application of any third party that potentially interferes with a Company Patent; all products made, used or sold under the Company Patents have been marked with the proper patent notice.
(f) There
are no pending or, to the Knowledge of the Company, threatened claims against the Company or any of its employees alleging that any of the operation of the Company
Business or any activity by the Company, or the manufacture, sale, offer for sale, importation, and/or use of any Company Product infringes or violates (or in the past infringed or violated) the
rights of others in or to any Intellectual Property ("
Third Party Intellectual Property
") or constitutes a misappropriation of (or in the past
constituted a misappropriation of) any subject matter of any Intellectual Property of any person or entity or that any Company Intellectual Property is invalid or unenforceable.
(g) To
the Knowledge of the Company, neither the operation of the Company Business, nor any activity by the Company, nor manufacture, use, importation, offer for sale and/or
sale of any Company Product infringes or violates (or in the past infringed or violated) any Third Party Intellectual Property or constitutes a misappropriation of (or in the past constituted a
misappropriation of) any subject matter of any Third Party Intellectual Property.
(h) The
Company has no obligation to compensate any person for the use of any Intellectual Property; the Company has not entered into any agreement to indemnify any other
person against any claim of infringement or misappropriation of any Intellectual Property; there are no settlements, covenants not to sue, consents, judgments, or orders or similar obligations that:
(i) restrict the rights of the Company to use any Intellectual Property, (ii) restrict the Company Business, in order to accommodate a third party's Intellectual Property, or
(iii) permit third parties to use any Company Intellectual Property.
(i) All
former and current employees, consultants and contractors of the Company have executed written instruments with the Company that assign to the Company, all rights,
title and interest in and to any and all (i) inventions, improvements, discoveries, writings and other works of authorship, and information relating to the Company Business or any of the
products or services being researched,
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developed,
manufactured or sold by the Company or that may be used with any such products or services and (ii) Intellectual Property relating thereto; in each case where a Company Patent is
held by the Company by assignment, the assignment has been duly recorded with the U.S. Patent and Trademark Office and all similar offices and agencies anywhere in the world in which foreign
counterparts are registered or issued.
(j) To
the Knowledge of the Company, (i) there is no, nor has there been any, infringement or violation by any person or entity of any Company Intellectual Property
or the rights of the Company therein or thereto and (ii) there is no, nor has there been any, misappropriation by any person or entity of any Company Intellectual Property or the subject matter
thereof.
(k) The
Company has taken reasonable security measures to protect the secrecy, confidentiality and value of all Trade Secrets owned by the Company or used or held for use by
the Company in the Company Business (the "
Company Trade Secrets
"), including, without limitation, requiring each employee and consultant of the Company
and any other person with access to Company Trade Secrets to execute a binding confidentiality agreement, copies or forms of which have been provided to Saffron and, to the Knowledge of the Company,
there has not been any breach by any party to such confidentiality agreements.
(l) Following
the Effective Time, the Surviving Corporation will have the same rights and privileges in the Company Intellectual Property as the Company had in the Company
Intellectual Property immediately prior to the Effective Time.
2.10 Material Contracts
.
Section 2.10
of the Company Disclosure Schedule is a correct and complete list of each currently effective Company Contract:
(a) the
Company Leases and the Company Ancillary Lease Documents;
(b) for
the purchase of materials, supplies, goods, services, equipment or other assets for annual payments by the Company of, or pursuant to which in the last year the
Company paid, in the aggregate, $100,000 or more;
(c) for
the sale of materials, supplies, goods, services, equipment or other assets for annual payments to the Company of, or pursuant to which in the last year the Company
received, in the aggregate, $100,000 or more;
(d) that
relates to any partnership, joint venture, strategic alliance or other similar Contract;
(e) relating
to Indebtedness for borrowed money or the deferred purchase price of property (whether incurred, assumed, guaranteed or secured by any asset), except for
Contracts relating to Indebtedness in an amount not exceeding $100,000 in the aggregate;
(f) severance
or change-in-control Contracts;
(g) which
by its terms limits in any material respect (i) the localities in which all or any significant portion of the business and operations of the Company or,
following the consummation of the Contemplated Transactions, the business and operations of the Surviving Corporation, Saffron or any Affiliate of Saffron, is or would be conducted, or (ii) the
scope of the business and operations of the Company;
(h) in
respect of any Company Intellectual Property that provides for annual payments of, or pursuant to which in the last year the Company paid or received, in the
aggregate, $100,000 or more;
(i) containing
any royalty, dividend or similar arrangement based on the revenues or profits of the Company;
(j) with
any Governmental Authority;
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(k) any
Contract with (a) an executive officer or director of the Company or any of such executive officer's or director's immediate family members, (b) an
owner of more than five percent (5%) of the voting power of the outstanding capital stock of the Company or (c) to the Knowledge of the Company, any "related person" (within the meaning of
Item 404 of Regulation S-K under the Securities Act) of any such officer, director or owner (other than the Company);
(l) any
agreement that gives rise to any material payment or benefit as a result of the performance of this Agreement or any of the other Contemplated Transactions;
(m) relating
to the acquisition or disposition of any material interest in, or any material amount of, property or assets of the Company or for the grant to any Person of
any preferential rights to purchase any of its assets, other than in the Ordinary Course of Business; or
(n) any
other agreement (or group of related agreements) the performance of which requires aggregate payments to or from the Company in excess of $100,000.
The
Company has delivered or made available to Saffron accurate and complete (except for applicable redactions thereto) copies of all material written Company Contracts, including all
amendments thereto. There are no material Company Contracts that are not in written form. Except as set forth on
Section 2.10
of the Company
Disclosure Schedule, neither the Company nor, to the Knowledge of the Company, any other party to a Company Material Contract (as defined below), has breached, violated or defaulted under, or received
notice that it has breached, violated or defaulted under, any of the terms or conditions of any of the agreements, contracts or commitments to which the Company is a party or by which it is bound of
the type described in clauses (a) through (n) above or any Company Contract listed in
Section 2.14
or
Section 2.15
of the Company
Disclosure Schedule (any such agreement, contract or commitment, a "
Company Material
Contract
") in such manner as would permit any other party to cancel or terminate any such Company Material Contract, which has had or would reasonably be expected to have a
Company Material Adverse Effect. As to the Company, as of the date of this Agreement, each Company Material Contract is valid, binding, enforceable and in full force and effect, subject to: (i) Laws
of general application relating to bankruptcy, insolvency and the relief of debtors; and (ii) rules of Law governing specific performance, injunctive relief and other equitable remedies. The
consummation of the Contemplated Transactions will not (either alone or upon the occurrence of additional acts or events) result in any material payment or payments becoming due from the Company or
the Surviving Corporation to any Person under any Company Material Contract or give any Person the right to terminate or alter the provisions of any Company Material Contract. No Person is
renegotiating any material amount paid or payable to the Company under any Company Material Contract or any other material term or provision of any Company Material Contract.
2.11 Absence of Undisclosed Liabilities
.
The Company has no liability, Indebtedness, obligation, expense, claim, deficiency, guaranty or endorsement of any kind, whether accrued, absolute, contingent, matured, unmatured or
other (whether or not required to be reflected in the financial statements in accordance with GAAP) (each a "
Liability
"), individually or in the
aggregate, except for: (a) Liabilities identified as such in the "liabilities" column of the Company Balance Sheet; (b) normal and recurring current Liabilities that have been incurred
by the Company since the date of the Company Balance Sheet in the Ordinary Course of Business and which are not in excess of $100,000 in the aggregate; (c) Liabilities for performance of
obligations of the Company under Contracts (other than for breach thereof); (d) Liabilities described in
Section 2.11
of the Company
Disclosure Schedule; and (e) Liabilities incurred in connection with the Contemplated Transactions.
2.12 Compliance with Laws; Regulatory Compliance.
(a) The
Company is in compliance with all Laws or Orders, except where any such failure to be in compliance has not had, or would not reasonably be expected to have,
individually or in the
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aggregate,
a Company Material Adverse Effect. No investigation, inquiry, proceeding or similar action by any Governmental Authority with respect to the Company is pending or, to the Knowledge of the
Company, threatened in writing, nor has any Governmental Authority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a material and
adverse impact on the Company.
(b) Except
as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and its employees
and agents hold all permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and approvals from the U.S. Food and Drug Administration (the
"
FDA
") and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Company
Products (any such Governmental Authority, a "
Company Regulatory Agency
") necessary for the lawful operating of the businesses of the Company as
currently conducted (the "
Company Permits
"), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended
(the "
FDCA
"), and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the
"
PHSA
"), and the regulations of the FDA promulgated thereunder. Notwithstanding the foregoing, it is acknowledged that no Company Product is a marketed
product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and/or approvals will be required
before any Company Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Company
Permits are valid, and in full force and effect. Since January 1, 2015, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving
to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has not had, and would not reasonably be expected to
have, individually or in the aggregate, a Company Material Adverse Effect. The Company is in compliance in all material respects with the terms of all Company Permits, and no event has occurred that,
to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Company Permit, except as has not had, and would not
reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) None
of the Company nor, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or
failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Agency to invoke its policy with respect to "Fraud, Untrue Statements of
Material Facts, Bribery, and Illegal Gratuities," as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. None of the Company nor, to the Knowledge of the Company, any
director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care Laws (including without limitation the
U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), False Claims Act (31 U.S.C.
§§ 3729
et seq
.), Health Insurance Portability and Accountability Act (42 U.S.C. § 1320d
et seq
.), as amended by the Health
Information, Technology for Economic and Clinical Health Act of 2009, the civil monetary penalty laws (42 U.S.C.
§ 1320a-7a), the FDCA, the PHSA and any comparable state or foreign Laws), or the regulations promulgated pursuant to such Laws (each, a "
Health Care
Law
"). There is no civil, criminal, administrative or other proceeding, notice or demand pending, received or, to the Knowledge of the Company, threatened in writing against
the Company that relates to an alleged violation of any Health Care Law. None of the Company nor, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, has
been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. sec. 335a(b) or any similar
Law. There are no consent decrees (including plea agreements) or similar
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actions
to which the Company or, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, are bound or which relate to Company Products.
(d) The
Company is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other
Company Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Company Products. All required pre-clinical toxicology studies
conducted by or, to the Knowledge of the Company, on behalf of the Company and Company-sponsored clinical trials (or clinical trials sponsored by the Company) conducted or, to the Knowledge of the
Company, being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable
requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. The results of any such
studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to Saffron. Each clinical trial conducted by or, to the Knowledge of
the Company, on behalf of the Company with respect to Company Products has been conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable
Laws, including FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211 and 312. The Company has filed all required
notices (and made available to Saffron copies thereof) of adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of the Company with respect to such Company
Products.
(e) All
applications, submissions, information and data utilized by the Company as the basis for, or submitted by or on behalf of the Company in connection with any and all
requests for a Company Permit relating to the Company, when submitted to the FDA or other Company Regulatory Agency, were true, correct and complete in all material respects as of the date of
submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Company
Regulatory Agency.
(f) None
of the Company nor, to the Knowledge of the Company, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any written
notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug
Application sponsored by the Company or otherwise restrict the pre-clinical research or clinical study of any Company Product or any drug product being developed by any licensee or assignee of the
Company Intellectual Property based on such intellectual property, or to recall, suspend or otherwise materially restrict the development or manufacture of any Company Product. The Company is not in
receipt of written notice of, and is not subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand,
claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Company Products. To the Knowledge of the Company, there is no act, omission, event or circumstance
that would reasonably be expected to give rise to any such action.
(g) The
Company has made available to Saffron true, correct and complete copies of any and all applications, approvals, licenses, written notices of inspectional
observations, establishment inspection reports and any other documents received from the FDA or other Company Regulatory Agency, including documents that indicate or suggest lack of compliance with
the Laws of the FDA or other Company Regulatory Agency. The Company has made available to Saffron for review all correspondence to or from the FDA or other Company Regulatory Agency, minutes of
meetings, written reports of phone conversations, visits or other contact with the FDA or other Company Regulatory Agency, notices of inspectional observations, establishment inspection reports, and
all other documents concerning communications to or from the FDA or other Company Regulatory Agency, or prepared by the FDA or other Company Regulatory Agency or which bear in any way on the Company's
compliance with the Laws of the FDA or any other Company Regulatory Agency, or on the likelihood or timing of approval of any Company Products.
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2.13 Taxes and Tax Returns.
(a) Each
material Tax Return required to be filed by, or on behalf of, the Company has been timely filed (taking into account any valid extensions). Each such Tax Return is
true, correct and complete in all material respects.
(b) The
Company (i) has paid (or has had paid on its behalf) all material Taxes due and owing, whether or not shown as due on any Tax Return, except to the extent
that any such Taxes are being contested in good faith and for which adequate reserves have been made on the Company Balance Sheet, and (ii) has withheld and remitted to the appropriate Taxing
Authority, or properly set aside, all material Taxes required to be withheld and paid in connection with any amounts paid or owing to or collected from any employee, independent contractor, supplier,
creditor, stockholder, partner, member or other third party, and all Forms W-2 and 1099 required with respect thereto have been properly completed and timely filed.
(c) The
unpaid Taxes of the Company (i) did not, as of December 31, 2015, exceed the aggregate reserve for Tax liability (rather than any reserve for deferred
Taxes established to reflect timing differences between book and Tax income) set forth on the face of the Company Balance Sheet (rather than in any notes thereto) and (ii) will not exceed that
reserve as adjusted for operations and transactions through the Closing Date in accordance with the past custom and practice of the Company in filing its Tax Returns.
(d)
Section 2.13(d)
of the Company Disclosure Schedule lists all federal, state, local and foreign Tax Returns filed
with respect to the Company for all taxable periods ending prior to the Closing Date that are still open to examination under all applicable statutes of limitations, indicates those Tax Returns that
have been audited, and indicates those Tax Returns that currently are the subject of audit. The Company has delivered to Saffron correct and complete copies of all U.S. federal income Tax Returns,
examination reports, and statements of deficiencies assessed against, or agreed to by the Company for all taxable periods ending prior to the Closing Date that are still open to examination under all
applicable statutes of limitations.
(e) There
are no liens for Taxes (other than Taxes not yet due and payable) upon any of the assets of the Company.
(f) The
Company is not currently the beneficiary of any extension of time within which to file any material Tax Return or with respect to any material Tax assessment or
deficiency.
(g) The
Company has not waived any statute of limitations with respect to any material Taxes or agreed to any extension of the period for assessment or collection of any
Taxes.
(h) There
is no material Tax claim, audit, suit, or administrative or judicial Tax proceeding now pending or presently in progress or threatened in writing with respect to a
material Tax Return of the Company.
(i) The
Company has not received notice in writing of any proposed material deficiencies from any Taxing Authority.
(j) The
Company has not distributed stock of a corporation, or has had its stock distributed, in a transaction purported or intended to be governed in whole or in part by
Sections 355 or 361 of the Code.
(k) The
Company is not a party to or has any obligation under any Tax sharing agreement (whether written or not) or any Tax indemnity or other Tax allocation agreement or
arrangement (other than any such agreement entered into in the Ordinary Course of Business and the primary purpose of which does not relate to Taxes).
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(l) The
Company (A) is not nor has ever been a member of a group of corporations that files or has filed (or has been required to file) consolidated, combined, or
unitary Tax Returns or (B) has no liability for the Taxes of any person under Treasury Regulations Section 1.1502-6 (or any similar provision of state, provincial, local or foreign Law),
as a transferee or successor, by contract or otherwise.
(m) The
taxable year of the Company for all income Tax purposes is the fiscal year ended December 31, and the Company uses the accrual method of accounting for income
Tax purposes.
(n) The
Company has not been a United States real property holding corporation within the meaning of Section 897(c)(2) of the Code at any time during the applicable
period specified in Section 897(c)(1)(A)(ii) of the Code.
(o) The
Company has not participated in a listed transaction within the meaning of Treasury Regulations Section 1.6011-4 (or any predecessor provision).
(p) The
Company will not be required to include any material item of income in, or exclude any material item of deduction from, taxable income for any taxable period (or
portion thereof) ending after the Closing Date as a result of any:
(i) change
in method of accounting or use of an improper method of accounting for a taxable period ending on or prior to the Closing Date;
(ii) "closing
agreement" as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign income Tax Law) executed prior
to the Closing;
(iii) installment
sale or open transaction disposition made prior to the Closing;
(iv) prepaid
amount received prior to the Closing Date;
(v) election
with respect to income from the discharge of indebtedness under Section 108(i) of the Code; or
(vi) any
similar election, action, or agreement that would have the effect of deferring any Liability for income Taxes of the Company from any taxable period ending on or
before the Closing Date to any taxable period ending after such period.
(q) No
written claim has been made by any Taxing Authority that the Company is or may be subject to Tax or required to file a Tax Return in a jurisdiction where it
does not file Tax Returns, which could reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
2.14 Employee Benefit Programs.
(a)
Section 2.14(a)
of the Company Disclosure Schedule sets forth a list of every Employee Program maintained by the
Company (the "
Company Employee Programs
").
(b) Each
Company Employee Program that is intended to qualify under Section 401(a) of the Code has received a favorable determination or approval letter from the IRS
with respect to such qualification, or may rely on an opinion letter issued by the IRS with respect to a prototype plan adopted in accordance with the requirements for such reliance, or has time
remaining for application to the IRS for a determination of the qualified status of such Company Employee Program for any period for which such Company Employee Program would not otherwise be covered
by an IRS determination. To the Knowledge of the Company, no event or omission has occurred that would reasonably be expected to cause any Company Employee Program to lose its qualification or
otherwise fail to satisfy the relevant requirements to provide tax-favored benefits under the applicable Code Section (including without limitation Code Sections 105, 125, 401(a) and
501(c)(9)).
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(c) The
Company does not know, nor should it reasonably know, of any material failure of any party to comply with any Laws applicable with respect to the Company Employee
Programs. Except as would not, individually or in the aggregate, have a Company Material Adverse Effect, with respect to any Company Employee Program, there has been no (i) "prohibited
transaction," as defined in Section 406 of ERISA or Code Section 4975, (ii) failure to comply with any provision of ERISA, other applicable Laws, or any agreement, or
(iii) non-deductible contribution. No litigation or governmental administrative proceeding (or investigation) or other proceeding (other than those relating to routine claims for benefits) is
pending or, to the Knowledge of the Company, threatened with respect to any such Company Employee Program. All payments and/or contributions required to have been made (under the provisions of any
agreements or other governing documents or applicable Laws) with respect to all Company Employee Programs, for all periods prior to the Closing Date, either have been made or have been accrued.
(d) No
Company Employee Program is subject to Title IV of ERISA and/or Code Section 412, including a Multiemployer Plan and the Company does not have any liability
for any Employee Program maintained, contributed to, or required to be contributed to by an ERISA Affiliate that is subject to Title IV of ERISA. None of the Company Employee Programs provides health
care or any other non-pension benefits to any employees after their employment is terminated (other than as required by part 6 of subtitle B of title I of ERISA or state continuation Laws
(whether or not the Company subsidizes the premiums for such legally-required coverage) or to which the former employee pays all required premiums).
(e) Each
Company Employee Program may be amended, terminated, or otherwise discontinued by Saffron after the Effective Time in accordance with its terms without material
liability to the Company, Saffron or any of their respective Subsidiaries.
(f) The
Company is not a party to any written (i) agreement with any stockholders, director, or employee of the Company (A) the benefits of which are
contingent, or the terms of which are materially altered, upon the occurrence of a transaction involving the Company of the nature of any of the Contemplated Transactions, (B) providing any
guaranteed period of employment or compensation guarantee, or (C) providing severance benefits after the termination of employment of such director or employee; or (ii) agreement or plan
binding the Company, including any stock option plan, stock appreciation right plan, restricted stock plan, stock purchase plan, or severance benefit plan, any of the benefits of which shall be
increased, or the vesting of the benefits of which shall be accelerated, by the occurrence of any of the Contemplated Transactions or the value of any of the benefits of which shall be calculated on
the basis of any of the Contemplated Transactions.
(g) There
is no contract, agreement, plan or arrangement covering any individual that, by itself or collectively, would give rise to any parachute payment subject to
Section 280G of the Code, nor has Company made any such payment, and the consummation of the transactions contemplated herein shall not obligate Company or any other entity to make any
parachute payment that would be subject to Section 280G of the Code.
(h) Each
Company Employee Program that is a "nonqualified deferred compensation plan" within the meaning of Section 409A of the Code has been operated and maintained
in compliance with Section 409A of the Code in all material respects.
(i) For
purposes of this
Section 2.14
:
(i) An
entity "maintains" an Employee Program if such entity sponsors, contributes to, or provides benefits under or through such Employee Program, or has any obligation
(by agreement or under applicable Laws) to contribute to or provide benefits under or through such Employee Program, or if such Employee Program provides benefits to or otherwise covers or has covered
employees of such entity (or their spouses, dependents, or beneficiaries).
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(ii) An
entity is an "ERISA Affiliate" of Company if it would have ever been considered a single employer with Company under ERISA Section 4001(b) or part of the same
"controlled group" as Company for purposes of ERISA Section 302(d)(3).
2.15 Labor and Employment Matters.
(a) The
Company is not a party to, or otherwise bound by, any collective bargaining agreement, contract, or other written agreement with a labor union or labor organization.
To the Knowledge of the Company, the Company is not subject to, and during the past three (3) years there has not been, any charge, demand, petition, organizational campaign, or representation
proceeding seeking to compel, require, or demand it to bargain with any labor union or labor organization nor is there pending or threatened any labor strike or lockout involving the Company.
(b) Except
as would not, individually or in the aggregate, have a Company Material Adverse Effect, (i) the Company is in compliance with all applicable Laws
respecting labor, employment, fair employment practices, work safety and health, terms and conditions of employment, and wages and hours, including, but not limited to Title VII of the Civil Rights
Act of 1964, as amended, the Equal Pay Act of 1967, as amended, the Age Discrimination in Employment Act of 1967, as amended, the Americans with Disabilities Act, as amended, the Fair Labor Standards
Act, as amended, and its state law equivalents, and the related rules and regulations adopted by those federal agencies responsible for the administration of such Laws, and other than normal accruals
of wages during regular payroll cycles, there are no arrearages in the payment of wages; (ii) the Company is not delinquent in any payments to any employee or to any independent contractors,
consultants, temporary employees, leased employees or other servants or agents employed or used with respect to the operation of the Company Business and classified by the Company as other than an
employee or compensated other than through wages paid by the Company through its respective payroll department ("
Company Contingent Workers
"), for any
wages, salaries, commissions, bonuses, fees or other direct compensation due with respect to any services performed for it to the date hereof or amounts required to be reimbursed to such employees or
Company Contingent Workers; (iii) there are no grievances, complaints or charges with respect to employment or labor matters (including, without limitation, allegations of employment
discrimination, retaliation or unfair labor practices) pending or, to the Knowledge of the Company, threatened against the Company in any judicial, regulatory or administrative forum, under any
private dispute resolution procedure; (iv) none of the employment policies or practices of the Company is currently being audited or investigated, or to the Knowledge of the Company, subject to
imminent audit or investigation by any Governmental Authority; (v) the Company is not, and within the last three (3) years has not been, subject to any order, decree, injunction or
judgment by any Governmental Authority or private settlement contract in respect of any labor or employment matters; (vi) the Company is in material compliance with the requirements of the
Immigration Reform Control Act of 1986 and any similar Laws regarding employment of workers who are not citizens of the country in which services are performed; (vii) all employees of the
Company are employed at-will and no such employees are subject to any contract with the Company or any policy or practice of the Company providing for right of notice of termination of employment or
the right to receive severance payments or similar benefits upon the termination of employment by the Company; (viii) to the extent that any Company Contingent Workers are employed, the Company
has properly classified and treated them in accordance with applicable Laws and for purposes of all employee benefit plans and perquisites; (ix) the Company has not experienced a "plant
closing," "business closing," or "mass layoff" as defined in the Worker Adjustment and Retraining Notification Act (the "
WARN Act
") or any similar Law
affecting any site of employment of the Company or one or more facilities or operating units within any site of employment or facility of the Company, and, during the ninety (90)-day period preceding
the date hereof, no employee has suffered an "employment loss," as defined in the WARN Act, with respect to the Company; (x) the Company has properly classified its employees as exempt or
non-exempt under the Fair Labor Standards Act, as amended, its state law equivalents, and all other
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relevant
Laws; and (xi) there are no pending or, to the Knowledge of the Company, threatened or reasonably anticipated claims or actions against the Company under any workers' compensation
policy or long-term disability policy.
2.16 Environmental Matters
.
Except as would not, individually or in the aggregate, have a Company Material Adverse Effect:
(a) the
Company is in compliance with all Environmental Laws applicable to their operations and use of the Company Leased Real Property;
(b) the
Company has not generated, transported, treated, stored, or disposed of any Hazardous Material, except in material compliance with all applicable Environmental Laws,
and there has been no Release or threat of Release of any Hazardous Material by the Company at or on the Company Leased Real Property that requires reporting, investigation or remediation by the
Company pursuant to any Environmental Law;
(c) the
Company has not (i) received written notice under the citizen suit provisions of any Environmental Law or (ii) been subject to or, to the Knowledge of
the Company, threatened with any governmental or citizen enforcement action with respect to any Environmental Law; and
(d) to
the Knowledge of the Company, there are no underground storage tanks, landfills, current or former waste disposal areas or polychlorinated biphenyls at or on the
Company Leased Real Property that require reporting, investigation, cleanup, remediation or any other type of response action by the Company pursuant to any Environmental Law.
2.17 Insurance
. The Company has delivered or made available to Saffron accurate
and complete copies of all material insurance policies and all material self-insurance programs and arrangements relating to the business, assets, liabilities and operations of the Company. Each of
such insurance policies is in full force and effect and the Company is in compliance with the terms thereof. Other than customary end of policy notifications from insurance carriers, since
January 1, 2015, the Company has not received any notice or other communication regarding any actual or possible: (i) cancellation or invalidation of any insurance policy;
(ii) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy; or (iii) material adjustment in the amount of the premiums
payable with respect to any insurance policy. There is no pending workers' compensation or other claim under or based upon any insurance policy of the Company. All information provided to insurance
carriers (in applications and otherwise) on behalf of the Company was, as of the date of such provision, accurate and complete. The Company has provided timely written notice to the appropriate
insurance carrier(s) of each Legal Proceeding pending or threatened against the Company, and no such carrier has issued a denial of coverage or a reservation of rights with respect to any such Legal
Proceeding, or informed the Company of its intent to do so.
2.18 Books and Records
.
Each of the minute and record books of the Company has been made available to Saffron and contains complete and accurate minutes of all meetings of, and copies of all bylaws and
resolutions passed by, or consented to in writing by, the directors (and any committees thereof) and stockholders of the Company, since its formation and which are required to be maintained in such
books under applicable Laws; all such meetings were duly called and held and all such bylaws and resolutions were duly passed or enacted. Each of the stock certificate books, registers of stockholders
and other corporate registers of the Company comply in all material respects with the provisions of all applicable Laws and are complete and accurate in all material respects.
2.19 Government Programs
.
No agreements, loans, funding arrangements or assistance programs are outstanding in favor of the Company from any Governmental Authority, and, to the Knowledge of the Company, no basis
exists for any Governmental Authority to seek payment or repayment from the Company of any amount or benefit received, or to seek performance of any obligation of the Company, under any such program.
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2.20 Transactions with Affiliates
.
Section 2.20
of the Company Disclosure Schedule describes any material transactions or relationships, since January 1, 2012,
between, on one hand, the Company and, on the other hand, any (a) executive officer or director of the Company or any of such executive officer's or director's immediate family members,
(b) owner of more than five percent (5%) of the voting power of the outstanding capital stock of the Company or (c) to the Knowledge of the Company, any "related person" (within the
meaning of Item 404 of Regulation S-K under the Securities Act) of any such officer, director or owner (other than the Company) in each of the case of (a), (b) or (c) that
is of the type that would be required to be disclosed under Item 404 of Regulation S-K under the Securities Act.
2.21 Legal Proceedings; Orders.
(a) Except
as set forth in
Section 2.21
of the Company Disclosure Schedule, there is no pending in writing Legal
Proceeding, and (to the Knowledge of the Company) no Person has threatened in writing to commence any Legal Proceeding: (i) that involves the Company, any director or officer of the Company (in
his or her capacity as such) or any of the material assets owned or used by the Company; or (ii) that challenges, or that may have the effect of preventing, delaying, making illegal or
otherwise interfering with, the Merger or any of the other Contemplated Transactions. To the Knowledge of the Company, no event has occurred, and no claim, dispute or other condition or circumstance
exists, that will, or that would reasonably be expected to, give rise to or serve as a basis for the commencement of any such Legal Proceeding. With regard to any Legal Proceeding set forth on
Section 2.21
of the Company Disclosure Schedule, the Company has provided Saffron or its counsel all pleadings and material written
correspondence related to such Legal Proceeding, all insurance policies and material written correspondence with brokers and insurers related to such Legal Proceedings and other information material
to an assessment of such Legal Proceeding. The Company has an insurance policy or policies that is expected to cover such Legal Proceeding and has complied with the requirements of such insurance
policy or policies to obtain coverage with respect to such Legal Proceeding under such insurance policy or policies.
(b) There
is no order, writ, injunction, judgment or decree to which the Company, or any of the material assets owned or used by the Company, is subject. To the Knowledge of
the Company, no officer or other key employee of the Company is subject to any order, writ, injunction, judgment or decree that prohibits such officer or other employee from engaging in or continuing
any conduct, activity or practice relating to the Company Business or to any material assets owned or used by the Company.
2.22 Illegal Payments
.
The Company (including any of its officers or directors) has not taken or failed to take any action which would cause it to be in material violation of the Foreign Corrupt Practices Act
of 1977, the U.K. Anti-Bribery Act of 2010, the Unfair Competition Prevention Act of Japan or any similar anti-bribery or anti-corruption Law of any similar Law of any other jurisdiction, in each case
as amended, or any rules or regulations thereunder. None of the Company or, to the Knowledge of the Company, any third party acting on behalf of the Company, has offered, paid, promised to pay, or
authorized, or will offer, pay, promise to pay, or authorize, directly or indirectly, the giving of money or anything of value to any Official, or to any other Person while knowing or being aware of a
high probability that all or a portion of such money or thing of value will be offered, given or promised, directly or indirectly, to any Official, for the purpose of: (i) influencing any act
or decision of such Official in his, her or its official capacity, including a decision to fail to perform his, her or its official duties or functions; or (ii) inducing such Official to use
his, her or its influence with any Governmental Authority to affect or influence any act or decision of such Governmental Authority, or to obtain an improper advantage in order to assist the Company
or any other Person in obtaining or retaining business for or with, or directing business to, the Company. For purposes of this Agreement, an "
Official
"
shall include any appointed or elected official, any government employee, any political
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party,
party official, or candidate for political office, or any officer, director or employee of any Governmental Authority.
2.23 Inapplicability of Anti-takeover Statutes
.
The Board of Directors of the Company has taken and will take all actions necessary to ensure that the restrictions applicable to business combinations contained in Section 203 of
the DGCL are, and will be, inapplicable to the execution, delivery and performance of this Agreement and to the consummation of the Merger and the other Contemplated Transactions. No other state
takeover statute or similar Law applies or purports to apply to the Merger, this Agreement, or any of the other Contemplated Transactions.
2.24 Vote Required
.
The affirmative vote (or action by written consent) of (i) the holders of a majority of the Company Common Stock and Company Preferred Stock, voting together as a single class (on
an as-converted to Company Common Stock basis) (the "
Company Stockholder Approval
"), is the only vote or consent of the holders of any class or series
of Company Capital Stock necessary to adopt or approve this Agreement, and approve the Merger, the Contemplated Transactions and the other matters set forth in
Section 5.2(a)
of this Agreement.
2.25 No Financial Advisor
.
Except as set forth on
Section 2.25
of the Company Disclosure Schedule, no broker, finder or investment banker is entitled to any
brokerage fee, finder's fee, opinion fee, success fee, transaction fee or other fee or commission in connection with the Merger or any of the other Contemplated Transactions based upon arrangements
made by or on behalf of the Company.
2.26 Disclosure; Company Information
.
The information in the Proxy Statement relating to the Company (including any Company Final Financial Statements) will not, on the date the Proxy Statement is first mailed to the Saffron
Stockholders or at the time of the Saffron Stockholder Meeting, contain any untrue statement of any material fact, or omit to state any material fact required to be stated therein or necessary in
order to make the statements therein not false or misleading at the time and in light of the circumstances under which such statement is made. Notwithstanding the foregoing, no representation is made
by the Company with respect to the information that has been or will be supplied by Saffron and Merger Sub or any of their Representatives for inclusion in the Proxy Statement.
Section 3. REPRESENTATIONS AND WARRANTIES OF SAFFRON AND MERGER SUB
Saffron
and Merger Sub represent and warrant to the Company as follows, except as set forth in (x) the Saffron SEC Reports filed prior to the date hereof or (y) the written
disclosure schedule delivered by Saffron to the Company (the "
Saffron Disclosure Schedule
"). The Saffron Disclosure Schedule shall be arranged in parts
and subparts corresponding to the numbered and lettered sections and subsections contained in this
Section 3
. The disclosures in any part or
subpart of the Saffron Disclosure Schedule shall qualify other Sections and subsections in this
Section 3
only to the extent it is clear from the
face of the disclosure that such disclosure is applicable to such other Sections and subsections.
3.1 Organization.
(a) Saffron
is a corporation, duly organized, validly existing and in good corporate standing under the Laws of the State of Delaware. Saffron has all requisite corporate
power and authority to own, lease and operate all of its properties and assets and to carry on its business as it is now being conducted. Saffron is duly licensed or qualified to do business and is in
corporate good standing in each jurisdiction in which the nature of the business conducted by it or the character or location of the properties and assets owned, leased, or operated by it makes such
licensing or qualification necessary, except where the failure to be so licensed or qualified and in corporate good standing would not, either individually or in the aggregate, reasonably be expected
to have a Saffron Material Adverse Effect. The Saffron Charter and Saffron Bylaws, copies of which have previously been made available to the Company, are true, correct and complete copies of such
documents as currently in effect and Saffron is
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not
in violation of any provision thereof. Other than the Saffron Charter and Saffron Bylaws, Saffron is not a party to or bound by or subject to any stockholder agreement or other agreement governing
the affairs of Saffron or the relationships, rights and duties of stockholders and is not subject to a stockholder rights plan or similar plan.
(b) Merger
Sub is a corporation duly incorporated, validly existing and in good corporate standing under the Laws of the State of Delaware. Merger Sub was formed solely for
the purpose of engaging in the Contemplated Transactions. All of the issued and outstanding capital stock of Merger Sub, which consists of 100 shares of Common Stock, $0.0001 par value, is validly
issued, fully paid and non-assessable, and is owned, beneficially and of record, by Saffron, free and clear of any claim, lien, Encumbrance, or agreement with respect thereto. Except for obligations
and liabilities incurred in connection with its incorporation and the Contemplated Transactions, Merger Sub has not, and will not have, incurred, directly or indirectly, any obligations or liabilities
or engaged in any business activities of any type or kind whatsoever or entered into any agreements or arrangements with any Person. The Certificate of Incorporation and Bylaws of Merger Sub, copies
of which have previously been made available to the Company, are true, correct and complete copies of such documents as currently in effect and Merger Sub is not in violation of any provision thereof.
(c) Each
of Saffron's Subsidiaries is a corporation or legal entity, validly existing and, if applicable, in good standing under the Laws of the jurisdiction of its
organization. Each of Saffron's Subsidiaries has all requisite corporate power or other power and authority to own, lease and operate all of its properties and assets and to carry on its business as
it is now being conducted. Each of Saffron's Subsidiaries is duly licensed or qualified to do business in each jurisdiction in which the nature of the business conducted by it or the character or
location of the properties and assets owned, leased, or operated by it makes such licensing or qualification necessary, except where the failure to be so licensed or qualified and in good standing
would not, either individually or in the aggregate, reasonably be expected to have a Saffron Material Adverse Effect. The certificate of incorporation and bylaws or equivalent organizational documents
of each of Saffron's Subsidiaries (other than Merger Sub), copies of which have previously been made available to the Company, are true, correct and complete copies of such documents as currently in
effect and such Subsidiaries of Saffron are not in violation of any provision thereof.
3.2 Capitalization.
(a) As
of the date hereof, the authorized capital stock of Saffron consists of 200,000,000 shares of Saffron Common Stock and 5,000,000 shares Saffron Preferred Stock. As of
March 31, 2016, there are 137,806,441 shares of Saffron Common Stock issued and outstanding (of which 409,786 were shares of restricted stock of Saffron) and no shares of Saffron Preferred
Stock issued and outstanding. As of the date hereof, there are no shares of Saffron Common Stock and no shares of Saffron Preferred Stock held in the treasury of Saffron. Saffron has no shares of
Saffron Common Stock or Saffron Preferred Stock reserved for issuance other than as described above or as set forth in
Sections 3.2(b)
or
3.2(c)
below. The outstanding shares of Saffron Common Stock have been duly authorized, validly issued, fully paid and nonassessable, and were not
issued in violation of the material terms of any agreement or understanding binding upon Saffron at the time at which they were issued and were issued in compliance with the Saffron Charter and
Saffron Bylaws and all applicable Laws. Except for the Saffron Stock Option Plans and the Saffron Warrants, Saffron does not have and is not bound by any outstanding subscriptions, options, warrants,
calls, commitments, rights agreements, or agreements of any character calling for Saffron to issue, deliver, or sell, or cause to be issued, delivered, or sold any shares of Saffron Common Stock or
any other equity security of Saffron or any Subsidiary of Saffron or any securities convertible into, exchangeable for, or representing the right to subscribe for, purchase, or otherwise receive any
shares of Saffron Common Stock or any other equity security of Saffron or any Subsidiary of Saffron or obligating Saffron or any such Subsidiary to grant, extend, or enter into any such subscriptions,
options, warrants, calls, commitments, rights agreements, or any other similar agreements. There are no registration rights, repurchase or redemption rights, anti-dilutive rights, voting agreements,
voting trusts, preemptive rights or restrictions on transfer relating to any capital stock of Saffron.
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(b) As
of March 31, 2016, there are 7,335,500 shares of Saffron Common Stock issuable upon exercise of all outstanding Saffron Stock Options, subject to adjustment on
the terms set forth in the Saffron Stock Option Plans.
Section 3.2(b)
of the Saffron Disclosure Schedule sets forth a true, correct and complete
list, as of the date hereof, of (i) the name of the holder of each Saffron Stock Option, (ii) the date each Saffron Stock Option was granted, (iii) the number, issuer and type of
securities subject to each such Saffron Stock Option, (iv) the expiration date of each such Saffron Stock Option, (v) the vesting schedule of each such Saffron Stock Option,
(vi) the price at which each such Saffron Stock Option (or each component thereof, if applicable) may be exercised, (vii) the number of shares of Saffron Common Stock issuable upon the
exercise of such, or upon the conversion of all securities issuable upon the exercise of such, Saffron Stock Options and (viii) whether and to what extent the exercisability of each Saffron
Stock Option will be accelerated upon consummation of the Contemplated Transactions or any termination of employment thereafter.
(c) As
of March 31, 2016, there are 409,786 shares of Saffron Common Stock subject to lapsing forfeiture rights under outstanding Saffron Restricted Stock Awards and
5,000,000 shares of Saffron Common Stock subject to outstanding Saffron Restricted Stock Unit Awards.
Section 3.2(c)
of the Saffron Disclosure
Schedule sets forth each Saffron Restricted Stock Award and Saffron Restricted Stock Unit Award outstanding as of the date hereof and the number of shares of Saffron Common Stock subject to the award.
(d)
Section 3.2(d)
of the Saffron Disclosure Schedule lists each Subsidiary of Saffron, other than Merger Sub, as of
the date hereof and indicates for each such Subsidiary as of such date (i) the percentage and type of equity securities owned or controlled, directly or indirectly, by Saffron and
(ii) the jurisdiction of incorporation or organization. No Subsidiary of Saffron has or is bound by any outstanding subscriptions, options, warrants, calls, commitments, rights agreements, or
agreements of any character calling for it to issue, deliver, or sell, or cause to be issued, delivered, or sold any of its equity securities or any securities convertible into, exchangeable for, or
representing the right to subscribe for, purchase or otherwise receive any such equity security or obligating such Subsidiary to grant, extend or enter into any such subscriptions, options, warrants,
calls, commitments, rights agreements, or other similar agreements. There are no outstanding contractual obligations of any Subsidiary of Saffron to repurchase, redeem, or otherwise acquire any of its
capital stock or other equity interests. All of the shares of capital stock of each of the Subsidiaries of Saffron (A) have been duly authorized and are validly issued, fully paid (to the
extent required under the applicable governing documents) and nonassessable, (B) are owned by Saffron free and clear of any claim, lien, Encumbrance (other than Permitted Encumbrances), or
agreement with respect thereto, (C) were not issued in violation of the material terms of any agreement or understanding binding upon Saffron or any of its Subsidiaries at the time at which
they were issued and (D) were issued in compliance with the applicable governing documents and all applicable Laws.
(e) The
Saffron Common Stock to be issued in the Merger will, when issued in accordance with the provisions of this Agreement, have been duly authorized, and be validly
issued, fully paid and nonassessable.
3.3 Authority
. Each of Saffron and Merger Sub has all
requisite corporate power and authority to execute and deliver this Agreement and to consummate the Contemplated Transactions and perform its respective obligations hereunder, subject only to
obtaining Saffron Stockholder Approvals. The adoption, execution, delivery and performance of this Agreement and the approval of the consummation of the Contemplated Transactions have been duly and
validly adopted and approved by each of the boards of directors of Saffron and Merger Sub by unanimous vote of the directors participating in such votes. The Board of Directors of Saffron has
recommended that the stockholders of Saffron approve the Saffron Stockholder Proposals at the Saffron Stockholder Meeting. The Board of Directors of Merger Sub has declared this Agreement advisable
and has recommended that the sole stockholder of Merger Sub adopt this Agreement and approve the Merger. Except for Saffron
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Stockholder
Approvals and the filing of the Certificate of Merger with the Secretary of State of the State of Delaware, no other corporate proceeding on the part of Saffron or Merger Sub is necessary
to authorize the adoption, execution, delivery and performance of this Agreement or to consummate the Merger and the other Contemplated Transactions. This Agreement has been duly and validly executed
and delivered by Saffron and Merger Sub, and (assuming due authorization, execution and delivery by
the other parties hereto), constitutes the legal, valid and binding obligations of Saffron and Merger Sub, enforceable against Saffron and Merger Sub in accordance with its terms, subject to
applicable bankruptcy, insolvency, reorganization, moratorium, or other similar Laws relating to creditors' rights and general principles of equity. All other documents required to be executed by
Saffron and Merger Sub on or prior to the date hereof in connection with the transactions contemplated herein have been duly and validly executed and delivered by Saffron and Merger Sub and (assuming
due authorization, execution and delivery by the other parties thereto) constitute the legal, valid and binding obligations of Saffron and Merger Sub, respectively, enforceable against each of them in
accordance with their respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium, or other similar Laws relating to creditors' rights and general principles of equity.
3.4 Non-Contravention; Consents.
(a) The
execution and delivery of this Agreement by Saffron and Merger Sub does not, and the consummation by Saffron and Merger Sub of the Contemplated Transactions will
not, (i) conflict with, or result in any violation or breach of, any provision of the Saffron Charter or Saffron Bylaws or of the charter, bylaws, or other organizational document of any
Subsidiary of Saffron, (ii) conflict with, or result in any violation or breach of, or constitute (with or without notice or lapse of time, or both) a default (or give rise to a right of
termination, cancellation or acceleration of any obligation or loss of any material benefit) under, require a consent or waiver under, constitute a change in control under, require the payment of a
penalty under or result in the imposition of any Encumbrances on Saffron's or any of its Subsidiaries' assets under, any of the terms, conditions or provisions of any Saffron Material Contract or
other agreement, instrument or obligation to which Saffron or any of its Subsidiaries is a party or by which any of them or any of their properties or assets may be bound, or (iii) subject to
obtaining Saffron Stockholder Approval and subject to the consents, approvals and authorizations specified in clauses (i) through (v) of
Section 3.4(b)
having been obtained prior to the
Effective Time and all filings and notifications described in
Section 3.4(b)
having been made, conflict with or violate any Law applicable to Saffron or any of its Subsidiaries or any of its or
their
properties or assets, except in the case of clauses (ii) and (iii) of this
Section 3.4(a)
for any such conflicts, violations,
breaches, rights of termination, Encumbrances, penalties, defaults, terminations, cancellations, accelerations or losses that have not had, and would not reasonably be expected to result in, a Saffron
Material Adverse Effect.
(b) No
consent, approval, license, permit, order or authorization of, or registration, declaration, notice or filing with, any Governmental Authority is required by or with
respect to Saffron or any of its Subsidiaries in connection with the execution and delivery of this Agreement by Saffron and Merger Sub or the consummation by Saffron and Merger Sub of the
Contemplated Transactions, except for (i) obtaining the Saffron Stockholder Approval, (ii) the filing of the Certificate of Merger with the Delaware Secretary of State and appropriate
corresponding documents with the appropriate authorities of other states in which Saffron is qualified as a foreign corporation to transact business, (iii) any filings required to be made with
the SEC in connection with Saffron Stockholder Meeting, this Agreement and the Contemplated Transactions (including (A) the filing of the Proxy Statement with the SEC in accordance with the
Exchange Act and (B) the filing of a Form D Notice of Exempt Offering of Securities or other related filings in reliance on an exemption provided in Regulation D of the Securities
Act), (iv) such consents, approvals, orders, authorizations, registrations, declarations, notices and filings as may be required under applicable state securities Laws, the rules and
regulations of the NASDAQ Global Market, and (v) such other consents, licenses, permits, orders, authorizations, filings,
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approvals
and registrations which, if not obtained or made, have not had, and would not reasonably be expected to result in, a Saffron Material Adverse Effect.
3.5 SEC Filings; Financial Statements.
(a) Saffron
has filed or furnished, as applicable, on a timely basis all forms, statements, certifications, reports and documents required to be filed or furnished by it
with the SEC under the Exchange Act or the Securities Act since January 1, 2012 (the forms, statements, reports and documents filed or furnished since January 1, 2012 and those filed or
furnished subsequent to the date hereof, including any amendments thereto, the "
Saffron SEC Reports
"). Each of the Saffron SEC Reports, at the time of
its filing or being furnished complied in all material respects with the applicable requirements of the Securities Act, the Exchange Act and the Sarbanes-Oxley Act, and any rules and regulations
promulgated thereunder applicable to the Saffron SEC Reports, or, if not yet filed or furnished, will to the Knowledge of Saffron comply in all material respects with the applicable requirements of
the Securities Act, the Exchange Act and the Sarbanes-Oxley Act, and any rules and regulations promulgated thereunder applicable to the Saffron SEC Reports. As of their respective dates (or, if
amended prior to the date hereof, as of the date of such amendment), the Saffron SEC Reports did not contain any untrue statement of a material fact or omit to state a material fact required to be
stated therein or necessary to make the statements made therein, in light of the circumstances in which they were made, not misleading, and any Saffron SEC Reports filed or furnished with the SEC
subsequent to the date hereof will not to Saffron's knowledge, contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the
statements made therein, in light of the circumstances in which they were made, not misleading.
(b) As
of the date of this Agreement, Saffron has timely responded to all comment letters of the staff of the SEC relating to the Saffron SEC Reports, and the SEC has not
advised Saffron that any final responses are inadequate, insufficient or otherwise non-responsive. Saffron has made available to the Company true, correct and complete copies of all comment letters,
written inquiries and enforcement correspondence between the SEC, on the one hand, and Saffron and any of its Subsidiaries, on the other hand, occurring since January 1, 2015 and will,
reasonably promptly following the receipt thereof, make available to the Company any such correspondence sent or received after the date hereof. To the Knowledge of Saffron, as of the date of this
Agreement, none of the Saffron SEC Reports is the subject of ongoing SEC review or outstanding SEC comment.
(c) (i)
Each of the consolidated financial statements (including, in each case, any notes or schedules thereto) included in or incorporated by reference into the Saffron SEC
Reports fairly present, in all material respects, the consolidated financial position of Saffron and its consolidated Subsidiaries as of its date, or, in the case of the Saffron SEC Reports filed
after the date hereof, will fairly present, in all material respects, the consolidated financial position of Saffron and its consolidated Subsidiaries as of its date and each of the consolidated
statements of income, changes in stockholders' equity (deficit) and cash flows included in or incorporated by reference into the Saffron SEC Reports (including any related notes and schedules) fairly
presents in all material respects, the results of operations, retained earnings (loss) and changes in financial position, as the case may be, of such companies for the periods set forth therein
(except as indicated in the notes thereto, and in the case of unaudited statements, as may be permitted by the rules of the SEC, and subject to normal year-end audit adjustments that will not be
material in amount or effect), in each case in accordance with GAAP consistently applied during the periods involved, except as may be noted therein, or in the case of Saffron SEC Reports filed after
the date hereof, will fairly present, in all material respects, the results of operations, retained earnings (loss) and changes in financial position, as the case may be, of such companies for the
periods set forth therein (except as indicated in the notes thereto, and in the case of unaudited statements, as may be permitted by the rules of the SEC, and subject to normal year-end audit
adjustments that will not be material in amount or effect), in each case in accordance with GAAP
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consistently
applied during the periods involved, except as may be noted therein (the "
Saffron Financial Statements
").
(d) Saffron
has designed and maintains a system of internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act)
sufficient to provide reasonable assurance regarding the reliability of financial reporting, and, to the Knowledge of Saffron, such system is effective in providing such assurance. Saffron
(i) maintains disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) designed to ensure that information required to be disclosed by Saffron
in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC's rules and forms and, to the Knowledge of
Saffron, such disclosure controls and procedures are effective (ii) has disclosed, based on the most recent evaluation of its chief executive officer and its chief financial officer prior to
the date hereof, to Saffron's auditors and the Audit Committee of the Board of Directors of Saffron (and made summaries of such disclosures available to the Company) (A) (i) any significant
deficiencies in the design or operation of internal control over financial reporting that would adversely affect in any material respect Saffron's ability to record, process, summarize and report
financial information and (ii) any material weakness in internal control over financial reporting, and (B) any fraud, whether or not material, that involves management or other employees
who have a significant role in Saffron's internal controls over financial reporting. Each of Saffron and its Subsidiaries have materially complied with or substantially addressed such deficiencies,
material weaknesses or fraud. Saffron is in compliance in all material respects with all effective provisions of the Sarbanes-Oxley Act.
(e) Each
of the principal executive officer of Saffron and the principal financial officer of Saffron (or each former principal executive officer of Saffron and each former
principal financial officer of Saffron, as applicable) has made all certifications required by Rule 13a-14 or 15d-14 under the Exchange Act or Sections 302 and 906 of the Sarbanes-Oxley
Act and the rules and regulations of the SEC promulgated thereunder with respect to the Saffron SEC Reports, and the statements contained in such certifications were true and correct on the date such
certifications were made. For purposes of this
Section 3.5(e)
, "principal executive officer" and "principal financial officer" has the meanings
given to such terms in the Sarbanes-Oxley Act. None of Saffron or any of its Subsidiaries has outstanding, or has arranged any outstanding, "extensions of credit" to directors or executive officers in
violation of Section 402 of the Sarbanes-Oxley Act.
(f) Neither
Saffron or any of its Subsidiaries nor, to the Knowledge of Saffron, any director, officer, employee, or internal or external auditor of Saffron or any of its
Subsidiaries has received or otherwise had or obtained actual Knowledge of any substantive material complaint, allegation, assertion or claim, whether written or oral, that Saffron or any of its
Subsidiaries has engaged in questionable accounting or auditing practices.
3.6 Absence of Changes
.
Since December 31, 2015, Saffron and each of its Subsidiaries have conducted their respective businesses in all material respects in the Ordinary Course of Business consistent
with their past practices. Except as set forth (x) in Saffron SEC Reports and (y) on
Section 3.6
of the Saffron Disclosure
Schedule, after December 31, 2015 and on or before the date hereof:
(a) there
has not been any change, event, circumstance or condition to the Knowledge of Saffron that, individually or in the aggregate, has had, or would reasonably be
expected to have, a Saffron Material Adverse Effect;
(b) there
has been no split, combination or reclassification of any of the outstanding shares of Saffron's capital stock, and Saffron has not declared or paid any dividends
on or made any other distributions (in either case, in stock or property) on or in respect of the outstanding shares of Saffron's capital stock;
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(c) Saffron
has not allotted, reserved, set aside or issued, authorized or proposed the allotment, reservation, setting aside or issuance of, or purchased or redeemed or
proposed the purchase or redemption of, any shares in its capital stock or any class of securities convertible or exchangeable into, or rights, warrants or options to acquire, any such shares or other
convertible or exchangeable securities;
(d) except
as required as a result of a change in applicable Laws or GAAP, there has not been any material change in any method of accounting or accounting practice by
Saffron or any of its Subsidiaries;
(e) neither
Saffron nor any of its Subsidiaries has (i) acquired or sold, pledged, leased, encumbered or otherwise disposed of any material property or assets or
agreed to do any of the foregoing or (ii) incurred or committed to incur capital expenditures in excess of $100,000, in the aggregate;
(f) there
has been no transfer (by way of a license or otherwise) of, or agreement to transfer to, any Person's rights to any Saffron Intellectual Property;
(g) there
has been no notice delivered to Saffron or any of its Subsidiaries of any claim of ownership by a third party of any Saffron Intellectual Property owned or
developed by Saffron or any of its Subsidiaries, or of infringement by Saffron or any of its Subsidiaries of any third party's Intellectual Property;
(h) there
has not been any (i) grant of any severance or termination pay to any employee of Saffron; (ii) entry into any employment, deferred compensation,
severance or other similar plan or agreement (or any amendment to any such existing agreement) with any new or current employee of Saffron or any of its Subsidiaries; (iii) change in the
compensation, bonus or other benefits payable or to become payable to its directors, officers, employees or consultants, except in the Ordinary Course of Business consistent with past practice, or as
required by any pre-existing plan or arrangement set forth in
Section 3.6(h)
of the Saffron Disclosure Schedule; or (iv) termination of
any officers or key employees of Saffron or any of its Subsidiaries; or
(i) there
has not been any agreement to do any of the foregoing.
3.7 Title to Assets
.
Each of Saffron and its Subsidiaries owns, and has good and valid title to, or, in the case of leased properties and assets, valid leasehold interests in, all tangible properties or
assets and equipment used or held for use in its business or operations or purported to be owned by it. All of said assets are owned by Saffron or a Saffron Subsidiary free and clear of any
Encumbrances, except for: (i) any lien for current Taxes not yet due and payable or for Taxes that are being contested in good faith and for which adequate reserves have been made on Saffron's
audited consolidated balance sheet at December 31, 2015; (ii) minor liens that have arisen in the Ordinary Course of Business and that do not (in any case or in the aggregate) materially
detract from the value of the assets subject thereto or materially impair the operations of Saffron and its Subsidiaries, taken as a whole; and (iii) Encumbrances described in
Section 3.7
of
the Saffron Disclosure Schedule.
3.8 Properties.
(a)
Section 3.8(a)
of the Saffron Disclosure Schedule identifies (x) the street address of each parcel of
Saffron Leased Real Property, (y) the identification of the Saffron Lease and the Saffron Ancillary Lease Documents and (z) the identity of the lessor, lessee and current occupant (if
different than the lessee) of each such parcel of Saffron Leased Real Property. With respect to each Saffron Lease, except as would not, individually or in the aggregate, have a Saffron Material
Adverse Effect:
(i) the
Saffron Leases and the Saffron Ancillary Lease Documents are valid, binding and, subject to applicable bankruptcy, insolvency, reorganization, moratorium or other
similar Laws relating to creditors' rights and general principles of equity, enforceable and in full force and effect
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and
have not been modified or amended, and Saffron or a Subsidiary of the Saffron, as applicable, holds a valid and existing leasehold interest under such Saffron Leases free and clear of any
Encumbrances except Permitted Encumbrances. The Saffron and its Subsidiaries have delivered to Saffron full, complete and accurate copies of each of the Saffron Leases and all Saffron Ancillary Lease
Documents described in
Section 3.8(a)(i)
of the Saffron Disclosure Schedule;
(ii) none
of the Saffron Leased Real Property is subject to any Encumbrance other than a Permitted Encumbrance;
(iii) the
Saffron Leases and all Saffron Ancillary Lease Documents shall continue to be legal, valid, binding, enforceable and in full force and effect on identical terms
following the Closing;
(iv) with
respect to each of the Saffron Leases, none of Saffron or its Subsidiaries has exercised or given any notice of exercise, nor has any lessor or landlord exercised
or received any notice of exercise, of any option, right of first offer or right of first refusal contained in any such Saffron Lease or Saffron Ancillary Lease Document, including any such option or
right pertaining to purchase, expansion, renewal, extension or relocation;
(v) none
of Saffron or its Subsidiaries, nor, to the Knowledge of Saffron, any other party to any Saffron Leases or Saffron Ancillary Lease Documents is in breach or
default, and, to the Knowledge of Saffron, no event has occurred which, with notice or lapse of time, would constitute such a breach or default or permit termination, modification or acceleration
under the Saffron Leases or any Saffron Ancillary Lease Documents;
(vi) no
party to the Saffron Leases has repudiated any provision thereof and there are no disputes, oral agreements or forbearance programs in effect as to the Saffron
Leases; and
(vii) none
of Saffron or its Subsidiaries has assigned, transferred, conveyed, mortgaged, deeded in trust or encumbered any of its rights and interest in the leasehold or
subleasehold under any of the Saffron Leases or any Saffron Ancillary Lease Documents.
(b) Saffron
and its Subsidiaries own good title, free and clear of all Encumbrances, to all personal property and other non-real estate assets, in all cases excluding the
Saffron Intellectual Property, necessary to conduct the Saffron Business, except for Permitted Encumbrances. Saffron and its Subsidiaries, as lessees, have the right under valid and subsisting leases
to use, possess and control all personal property leased by Saffron and its Subsidiaries as now used, possessed and controlled by Saffron or its Subsidiaries, as applicable.
(c) The
Saffron Leased Real Property constitutes all of the real property used or occupied by Saffron and its Subsidiaries in connection with the conduct of the Saffron
Business.
(d) None
of Saffron or its Subsidiaries has any Saffron Owned Real Property, nor is Saffron or any of its Subsidiaries a party to or bound by or subject to any agreement,
contract or commitment, or any option to purchase, any real or immovable property.
3.9 Intellectual Property.
(a)
Section 3.9(a)
of the Saffron Disclosure Schedule contains a complete and accurate list of all (i) Patents
owned by Saffron or any of its Subsidiaries or used or held for use by Saffron or any of its Subsidiaries in the Saffron Business ("
Saffron Patents
"),
registered and material unregistered Marks owned by Saffron or any of its Subsidiaries or used or held for use by Saffron or any of its Subsidiaries in the Saffron Business
("
Saffron Marks
") and registered and material unregistered Copyrights owned by Saffron or any of its Subsidiaries or used or held for use by Saffron or
any of its Subsidiaries in the Saffron Business ("
Saffron Copyrights
"), (ii) licenses, sublicenses or other agreements under which Saffron or any
of its Subsidiaries is granted rights by others in the Saffron Intellectual Property ("
Saffron Licenses-In
") (other than commercial off the shelf
software or materials transfer
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agreements),
and (iii) licenses, sublicenses or other agreements under which Saffron or any of its Subsidiaries has granted rights to others in the Saffron Intellectual Property
("
Saffron Licenses-Out
").
(b) With
respect to the Saffron Intellectual Property (i) purported to be owned by Saffron or any of its Subsidiaries, Saffron or one of its Subsidiaries exclusively
owns such Saffron Intellectual Property and (ii) licensed to Saffron or any of its Subsidiaries by a third party (other than commercial off the shelf software or materials transfer agreements),
such Saffron Intellectual Property are the subject of a written license or other agreement; in the case of the foregoing clauses (i) and (ii) above, free and clear of all Encumbrances,
other than Encumbrances resulting from the express terms of a Saffron License-In or Saffron License-Out or Permitted Encumbrances granted by Saffron or one of its Subsidiaries.
(c) All
Saffron Intellectual Property owned by and, to the Knowledge of Saffron, all Saffron Intellectual Property owned by or exclusively licensed to Saffron or any of its
Subsidiaries that have been issued by, or registered with, or are the subject of an application filed with, as applicable, the U.S. Patent and Trademark Office, the U.S. Copyright Office or any
similar office or agency anywhere in the world are currently in compliance with formal legal requirements (including without limitation, as applicable, payment of filing, examination and maintenance
fees, inventor declarations, proofs of working or use, timely post-registration filing of affidavits of use and renewal applications), and, to the Knowledge of Saffron, all Saffron Patents, Saffron
Marks and Saffron Copyrights, and all intellectual property rights and/or proprietary rights relating to any of the foregoing, that are owned by or exclusively licensed to Saffron or any of its
Subsidiaries are valid and enforceable.
(d) To
the Knowledge of Saffron, each Saffron Patent that has been issued by, or registered with, or is the subject of an application filed with, as applicable, the U.S.
Patent and Trademark Office or any similar office or agency anywhere in the world was issued, registered, or filed, as applicable, with the correct inventorship and there has been no known misjoinder
or nonjoinder of inventors.
(e) No
Saffron Patent is now involved in any interference, reissue, re-examination or opposition proceeding; to the Knowledge of Saffron, there is no patent or patent
application of any third party that potentially interferes with a Saffron Patent; all products made, used or sold under the Saffron Patents have been marked with the proper patent notice.
(f) There
are no pending or, to the Knowledge of Saffron, threatened claims against Saffron or any of its Subsidiaries or any of their employees alleging that any of the
operation of the Saffron Business or any activity by Saffron or its Subsidiaries, or the manufacture, sale, offer for sale, importation, and/or use of any Saffron Product infringes or violates (or in
the past infringed or violated) any Third Party Intellectual Property or constitutes a misappropriation of (or in the past constituted a misappropriation of) any subject matter of any Intellectual
Property of any person or entity or that any Saffron Intellectual Property is invalid or unenforceable.
(g) To
the Knowledge of Saffron, neither the operation of the Saffron Business, nor any activity by Saffron or any of its Subsidiaries, nor manufacture, use, importation,
offer for sale and/or sale of any Saffron Product infringes or violates (or in the past infringed or violated) any Third Party Intellectual Property or constitutes a misappropriation of (or in the
past constituted a misappropriation of) any subject matter of any Third Party Intellectual Property.
(h) None
of Saffron or any of its Subsidiaries has any obligation to compensate any person for the use of any Intellectual Property; neither Saffron nor any of its
Subsidiaries has entered into any agreement to indemnify any other person against any claim of infringement or misappropriation of any Intellectual Property; there are no settlements, covenants not to
sue, consents, judgments, or orders or similar obligations that: (i) restrict Saffron's or any of its Subsidiaries' rights to use any Intellectual Property, (ii) restrict the Saffron
Business, in order to accommodate a third party's Intellectual Property, or (iii) permit third parties to use any Saffron Intellectual Property.
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(i) All
former and current employees, consultants and contractors of Saffron and its Subsidiaries have executed written instruments with Saffron or one or more of its
Subsidiaries that assign to Saffron all rights, title and interest in and to any and all (i) inventions, improvements, discoveries, writings and other works of authorship, and information
relating to the Saffron Business or any of the products or services being researched, developed, manufactured or sold by Saffron or any of its Subsidiaries or that may be used with any such products
or services and (ii) Intellectual Property relating thereto; in each case where a Saffron Patent is held by Saffron or any of its Subsidiaries by assignment, the assignment has been duly
recorded with the U.S. Patent and Trademark Office and all similar offices and agencies anywhere in the world in which foreign counterparts are registered or issued.
(j) To
the Knowledge of Saffron, (i) there is no, nor has there been any, infringement or violation by any person or entity of any Saffron Intellectual Property or
the rights of Saffron or any of its Subsidiaries therein or thereto and (ii) there is no, nor has there been any, misappropriation by any person or entity of any Saffron Intellectual Property
or the subject matter thereof.
(k) Saffron
and each of its Subsidiaries has taken reasonable security measures to protect the secrecy, confidentiality and value of all Trade Secrets owned by Saffron or
any of its Subsidiaries or used or held for use by Saffron or any of its Subsidiaries in the Saffron Business (the "
Saffron Trade Secrets
"), including,
without limitation, requiring each employee of Saffron and its Subsidiaries and each consultant of Saffron and its Subsidiaries and any other person with access to Saffron Trade Secrets to execute a
binding confidentiality agreement, copies or forms of which have been provided to the Company and, to Saffron's knowledge, there has not been any breach by any party to such confidentiality
agreements.
(l) Following
the Effective Time, the Surviving Corporation will have the same rights and privileges in the Saffron Intellectual Property as Saffron had in the Saffron
Intellectual Property immediately prior to the Effective Time.
3.10 Material Contracts
.
Section 3.10
of the Saffron Disclosure Schedule is a correct and complete list of each currently effective Saffron Contract:
(a) relating
to the lease of real property by Saffron or any of its Subsidiaries;
(b) for
the purchase of materials, supplies, goods, services, equipment or other assets for annual payments by Saffron or any of its Subsidiaries of, or pursuant to which in
the last year Saffron or any of its Subsidiaries paid, in the aggregate, $100,000 or more;
(c) for
the sale of materials, supplies, goods, services, equipment or other assets for annual payments to Saffron or any of its Subsidiaries of, or pursuant to which in the
last year Saffron or any of its Subsidiaries received, in the aggregate, $100,000 or more;
(d) that
relates to any partnership, joint venture, strategic alliance or other similar Contract;
(e) relating
to Indebtedness for borrowed money or the deferred purchase price of property (whether incurred, assumed, guaranteed or secured by any asset), except for
Contracts relating to Indebtedness in an amount not exceeding $100,000 in the aggregate;
(f) severance
or change-in-control Contracts;
(g) which
by its terms limits in any material respect (i) the localities in which all or any significant portion of the business and operations of Saffron or its
Subsidiaries or, following the consummation of the Contemplated Transactions, the business and operations of Surviving Corporation, Saffron or any Affiliate of Saffron, is or would be conducted, or
(ii) the scope of the business and operations of Saffron and its Subsidiaries, taken as a whole;
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(h) in
respect of any Saffron Intellectual Property that provides for annual payments of, or pursuant to which in the last year Saffron or any of its Subsidiaries paid or
received, in the aggregate, $100,000 or more;
(i) containing
any royalty, dividend or similar arrangement based on the revenues or profits of Saffron or any of its Subsidiaries;
(j) with
any Governmental Authority;
(k) any
Contract with (a) an executive officer or director of Saffron or any of its Subsidiaries or any of such executive officer's or director's immediate family
members, (b) an owner of more than five percent (5%) of the voting power of the outstanding capital stock of Saffron or (c) to the Knowledge of Saffron, any "related person" (within the
meaning of Item 404 of Regulation S-K under the Securities Act) of any such officer, director or owner (other than Saffron or its Subsidiaries);
(l) any
agreement that gives rise to any material payment or benefit as a result of the performance of this Agreement or any of the other Contemplated Transactions;
(m) relating
to the acquisition or disposition of any material interest in, or any material amount of, property or assets of Saffron or any of its Subsidiaries or for the
grant to any Person of any preferential rights to purchase any of their assets, other than in the Ordinary Course of Business; or
(n) any
other agreement (or group of related agreements) the performance of which requires aggregate payments to or from Saffron or any of its Subsidiaries in excess of
$100,000.
Saffron
has delivered or made available to the Company accurate and complete (except for applicable redactions thereto) copies of all material written Saffron Contracts, including all
amendments thereto. There are no material Saffron Contracts that are not in written form. Except as set forth on
Section 3.10
of the Saffron
Disclosure Schedule, neither Saffron nor any Subsidiary of Saffron has, nor to the Knowledge of Saffron, has any other party to a Saffron Material Contract (as defined below), breached, violated or
defaulted under, or received notice that it has breached, violated or defaulted under, any of the terms or conditions of any of the agreements, contracts or commitments to which Saffron or its
Subsidiaries is a party or by which it is bound of the type described in clauses (a) through (n) above or any Saffron Contract listed in
Section 3.14
or
Section 3.15
of the Saffron Disclosure Schedule (any such agreement,
contract or commitment, a "
Saffron Material Contract
") in such manner as would permit any other party to cancel or terminate any such Saffron Material
Contract, which has had or would reasonably be expected to have a Saffron Material Adverse Effect. As to Saffron and its Subsidiaries, as of the date of this Agreement, each Saffron Material Contract
is valid, binding, enforceable and in full force and effect, subject to: (i) Laws of general application relating to bankruptcy, insolvency and the relief of debtors; and (ii) rules of
Law governing specific performance, injunctive relief and other equitable remedies. The consummation of the Contemplated Transactions will not (either alone or upon the occurrence of additional acts
or events) result in any material payment or payments becoming due from Saffron, any Subsidiary of Saffron, or the Surviving Corporation to any Person under any Saffron Material Contract or give any
Person the right to terminate or alter the provisions of any Saffron Material Contract. No Person is renegotiating any material amount paid or payable to Saffron or any of its Subsidiaries under any
Saffron Material Contract or any other material term or provision of any Saffron Material Contract.
3.11 Absence of Undisclosed Liabilities
.
As of the date hereof, neither Saffron nor any Subsidiary of Saffron has any Liability, individually or in the aggregate, except for: (a) Liabilities identified as such in the
"liabilities" column of Saffron's audited consolidated balance sheet at December 31, 2015; (b) normal and recurring current Liabilities that have been incurred by Saffron since the date
of Saffron's audited consolidated balance sheet at December 31, 2015 in the Ordinary Course of Business; (c) Liabilities for performance of obligations of Saffron or any Subsidiary of
Saffron under Contracts (other than for breach thereof), (d) Liabilities described in
Section 3.11
of the Saffron Disclosure Schedule and
(e) Liabilities incurred in connection with the Contemplated Transactions.
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3.12 Compliance with Laws; Regulatory Compliance.
(a) Each
of Saffron and each of its Subsidiaries is in compliance with all Laws or Orders, except where any such failure to be in compliance has not had, or would not
reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect. No investigation, inquiry, proceeding or similar action by any Governmental Authority with respect
to Saffron or any of its Subsidiaries is pending or, to the Knowledge of Saffron, threatened in writing, nor has any Governmental Authority indicated in writing an intention to conduct the same which,
in each case, would reasonably be expected to have a material and adverse impact on Saffron or any of its Subsidiaries.
(b) Except
as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect, each of Saffron and its
Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and approvals from the FDA and any other
Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Saffron Products (any such Governmental Authority, a
"
Saffron Regulatory Agency
") necessary for the lawful operating of the businesses of Saffron and each of its Subsidiaries as currently conducted (the
"
Saffron Permits
"), including all authorizations required under the FDCA and the regulations of the FDA promulgated thereunder, and the PHSA and the
regulations of the FDA promulgated thereunder. Notwithstanding the foregoing, it is acknowledged that no Saffron Product is a marketed product or has received marketing approval and, therefore, that
further permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and/or approvals will be required before any Saffron Product may be marketed. Except as has not had,
and would not reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect, all such Saffron Permits are valid, and in full force and effect. Since
January 1, 2015, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or
cancellation of, with or without notice or lapse of time or both, any Saffron Permit except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Saffron
Material Adverse Effect. Each of Saffron and each of its Subsidiaries is in compliance in all material respects with the terms of all Saffron Permits, and no event has occurred that, to the Knowledge
of Saffron, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Saffron Permit, except as has not had, and would not reasonably be
expected to have, individually or in the aggregate, a Saffron Material Adverse Effect.
(c) None
of Saffron or its Subsidiaries nor, to the Knowledge of Saffron, any director, officer, employee, agent or Representative thereof, has committed any act, made any
statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Saffron Regulatory Agency to invoke its policy with respect to "Fraud, Untrue
Statements of Material Facts, Bribery, and Illegal Gratuities," as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. None of Saffron or its Subsidiaries nor, to the
Knowledge of Saffron, any director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under any Health Care Law. There is no civil, criminal, administrative or
other proceeding, notice or demand pending, received or, to the Knowledge of Saffron, threatened in writing against Saffron or any of its Subsidiaries that relates to an alleged violation of any
Health Care Law. None of Saffron or any of its Subsidiaries nor, to the Knowledge of Saffron, any director, officer, employee, agent or Representative thereof, has been convicted of any crime or
engaged in any conduct for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. sec. 335a(b) or any similar Law. There are no consent
decrees (including plea agreements) or similar actions to which Saffron or any of its Subsidiaries or, to the Knowledge of Saffron, any director, officer, employee, agent or Representative thereof,
are bound or which relate to Saffron Products.
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(d) Each
of Saffron and each of its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and
orders of the FDA and any other Saffron Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Saffron Products. All required
pre-clinical toxicology studies conducted by or, to the Knowledge of Saffron, on behalf of Saffron or its Subsidiaries and Saffron-sponsored clinical trials (or clinical trials sponsored by Saffron or
any other Subsidiary) conducted or, to the Knowledge of Saffron, being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses
and Laws, including, without limitation, the applicable requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54,
56, 58, 210, 211, and 312. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Company.
Each clinical trial conducted by or, to the Knowledge of Saffron, on behalf of Saffron or any of its Subsidiaries with respect to Saffron Products has been conducted in accordance with its clinical
trial protocol, and in compliance in all material respects with all applicable Laws, including FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R.
Parts 50, 54, 56, 58, 210, 211, and 312. Each of Saffron and its Subsidiaries has filed all required notices (and made available to the Company copies thereof) of serious adverse drug
experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Saffron or any of its Subsidiaries with respect to such Saffron Products.
(e) All
applications, submissions, information and data utilized by any Saffron or any of its Subsidiaries as the basis for, or submitted by or on behalf of Saffron or any
of its Subsidiaries in connection with any and all requests for a Saffron Permit relating to Saffron or any of its Subsidiaries, when submitted to the FDA or other Saffron Regulatory Agency, were
true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required
under applicable Laws have been submitted to the FDA or other Saffron Regulatory Agency.
(f) None
of Saffron or its Subsidiaries nor, to the Knowledge of Saffron, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any
written notice that the FDA or any other Saffron Regulatory Agency has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug
Application sponsored by Saffron or any of its Subsidiaries or otherwise restrict the pre-clinical research or clinical study of any Saffron Product or any drug product being developed by any licensee
or assignee of the Saffron Intellectual Property based on such intellectual property, or to recall, suspend or otherwise materially restrict the development or manufacture of any Saffron Product. None
of Saffron or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal
proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Saffron Products. To the Knowledge of Saffron, there is no act,
omission, event or circumstance that would reasonably be expected to give rise to any such action.
(g) Saffron
and its Subsidiaries have made available to the Company true, correct and complete copies of any and all applications, approvals, licenses, written notices of
inspectional observations, establishment inspection reports and any other documents received from the FDA or other Saffron Regulatory Agency, including documents that indicate or suggest lack of
compliance with the Laws of the FDA or other Saffron Regulatory Agency. Saffron and its Subsidiaries have made available to the Company for review all correspondence to or from the FDA or other
Saffron Regulatory Agency, minutes of meetings, written reports of phone conversations, visits or other contact with the FDA or other Saffron Regulatory Agency, notices of inspectional observations,
establishment inspection reports, and all other documents concerning communications to or from the FDA or other Saffron Regulatory Agency, or prepared by the FDA or other Saffron Regulatory Agency or
which bear in any way on
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Saffron's
or any of its Subsidiaries' compliance with the Laws of the FDA or any other Saffron Regulatory Agency, or on the likelihood or timing of approval of any Saffron Products.
3.13 Taxes and Tax Returns.
(a) Each
material Tax Return required to be filed by, or on behalf of, Saffron or any of its Subsidiaries, and each material Tax Return in which Saffron or any of its
Subsidiaries was required to be included, has been timely filed (taking into account any valid extensions). Each such Tax Return is true, correct and complete in all material respects.
(b) Saffron
and each of its Subsidiaries (i) has paid (or has had paid on its behalf) all material Taxes due and owing, whether or not shown as due on any Tax Return,
except to the extent that any such Taxes are being contested in good faith and for which adequate reserves have been made on the condensed balance sheet dated as of December 31, 2015 included
in the Saffron Financial Statements (the "
Saffron Balance Sheet
"), and (ii) has withheld and remitted to the appropriate Taxing Authority, or
properly set aside, all material Taxes required to be withheld and paid in connection with any amounts paid or owing to or collected from any employee, independent contractor, supplier, creditor,
stockholder, partner, member or other third party, and all Forms W-2 and 1099 required with respect thereto have been properly completed and timely filed.
(c) The
unpaid Taxes of Saffron and its Subsidiaries (A) did not, as of December 31, 2015, exceed the reserve for Tax liability (rather than any reserve for
deferred Taxes established to reflect timing differences between book and Tax income) set forth on the face of the Saffron Balance Sheet (rather than in any notes thereto) and (B) will not
exceed that reserve as adjusted for operations and transactions through the Closing Date in accordance with the past custom and practice of Saffron and its Subsidiaries in filing their Tax Returns.
(d)
Section 3.13(d
) of the Saffron Disclosure Schedule lists all federal, state, local, and foreign Tax Returns filed
with respect to Saffron or any of its Subsidiaries for taxable periods ending prior to the Closing Date that are still open to examination under all applicable statutes of limitations, indicates those
Tax Returns that have been audited, and indicates those Tax Returns that currently are the subject of audit. Saffron has delivered to the Company correct and complete copies of all U.S. federal income
Tax Returns, examination reports, and statements of deficiencies assessed against, or agreed to by Saffron or any of its Subsidiaries for all taxable periods ending prior to the Closing Date that are
still open to examination under all applicable statutes of limitations.
(e) There
are no liens for Taxes (other than Taxes not yet due and payable) upon any of the assets of Saffron or any of its Subsidiaries.
(f) None
of Saffron or any of its Subsidiaries is currently the beneficiary of any extension of time within which to file any material Tax Return or with respect to any
material Tax assessment or deficiency.
(g) None
of Saffron or any of its Subsidiaries has waived any statute of limitations with respect to any material Taxes or agreed to any extension of the period for
assessment or collection of any Taxes.
(h) There
is no material Tax claim, audit, suit, or administrative or judicial Tax proceeding now pending or presently in progress or threatened in writing with respect to a
material Tax Return of Saffron or any of its Subsidiaries.
(i) None
of Saffron or any of its Subsidiaries has received notice in writing of any proposed material deficiencies from any Taxing Authority.
(j) None
of Saffron or any of its Subsidiaries has distributed stock of a corporation, or has had its stock distributed, in a transaction purported or intended to be
governed in whole or in part by Sections 355 or 361 of the Code.
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(k) None
of Saffron or any of its Subsidiaries is party to or has any obligation under any Tax sharing agreement (whether written or not) or any Tax indemnity or other Tax
allocation agreement or arrangement (other than any such agreement entered into in the Ordinary Course of Business and the primary purpose of which does not relate to Taxes).
(l) None
of Saffron or any of its Subsidiaries (A) is or has ever been a member of a group of corporations that files or has filed (or has been required to file)
consolidated, combined, or unitary Tax Returns, other than a group the common parent of which was Saffron or (B) has any liability for the Taxes of any person (other than Saffron or any of its
Subsidiaries) under Treasury Regulations Section 1.1502-6 (or any similar provision of state, local or foreign Law), as a transferee or successor, by contract or otherwise.
(m) The
taxable year of Saffron and each of its Subsidiaries for all income Tax purposes is the fiscal year ended December 31, and Saffron and each of its
Subsidiaries uses the accrual method of accounting for income Tax purposes.
(n) None
of Saffron or any of its Subsidiaries has been a United States real property holding corporation within the meaning of Section 897(c)(2) of the Code at any
time during the applicable period specified in Section 897(c)(1)(A)(ii) of the Code.
(o) No
Subsidiary of Saffron which is a foreign corporation (i) shall have recognized a material amount of "subpart F income" as defined in Section 952
of the Code during a taxable year of such Subsidiary that includes but does not end on the Closing Date, (ii) is a resident of any jurisdiction other than that of its incorporation, or
(iii) is engaged in a U.S. trade or business.
(p) None
of Saffron or any of its Subsidiaries has participated in a listed transaction within the meaning of Treasury Regulations Section 1.6011-4 (or any
predecessor provision).
(q) None
of Saffron or any of its Subsidiaries will be required to include any material item of income in, or exclude any material item of deduction from, taxable income for
any taxable period (or portion thereof) ending after the Closing Date as a result of any:
(i) change
in method of accounting or use of an improper method of accounting for a taxable period ending on or prior to the Closing Date;
(ii) "closing
agreement" as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign income Tax Law) executed prior
to the Closing;
(iii) installment
sale or open transaction disposition made prior to the Closing;
(iv) prepaid
amount received prior to the Closing Date;
(v) election
with respect to income from the discharge of indebtedness under Section 108(i) of the Code; or
(vi) any
similar election, action, or agreement that would have the effect of deferring any Liability for income Taxes of Saffron or any of its Subsidiaries from any taxable
period ending on or before the Closing Date to any taxable period ending after such period.
(r) No
written claim has been made by any Taxing Authority that Saffron or any of its Subsidiaries is or may be subject to Tax or required to file a Tax Return in a
jurisdiction where it does not file Tax Returns, which could reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect.
3.14 Employee Benefit Programs.
(a)
Section 3.14(a)
of the Saffron Disclosure Schedule sets forth a list of every Employee Program maintained by
Saffron or any of its Subsidiaries (the "
Saffron Employee Programs
").
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(b) Each
Saffron Employee Program which is intended to qualify under Section 401(a) of the Code has received a favorable determination or approval letter from the IRS
with respect to such qualification, or may rely on an opinion letter issued by the IRS with respect to a prototype plan adopted in accordance with the requirements for such reliance, or has time
remaining for application to the IRS for a determination of the qualified status of such Saffron Employee Program for any period for which such Saffron Employee Program would not otherwise be covered
by an IRS determination. To the Knowledge of Saffron no event or omission has occurred which would reasonably be expected to cause any Saffron Employee Program to lose its qualification or otherwise
fail to satisfy the relevant requirements to provide tax-favored benefits under the applicable Code Section (including without limitation Code Sections 105, 125, 401(a) and 501(c)(9)).
(c) Neither
Saffron nor any Subsidiary of Saffron knows, nor should any of them reasonably know, of any material failure of any party to comply with any Laws applicable with
respect to the Saffron Employee Programs. Except as would not, individually or in the aggregate, have a Saffron Material Adverse Effect, with respect to any Saffron Employee Program, there has been no
(i) "prohibited transaction," as defined in Section 406 of ERISA or Code Section 4975, (ii) failure to comply with any provision of ERISA, other applicable Laws, or any
agreement, or (iii) non-deductible contribution. No litigation or governmental administrative proceeding (or investigation) or other proceeding (other than those relating to routine claims for
benefits) is pending or, to the Knowledge of Saffron, threatened with respect to any Saffron Employee Program. All payments and/or contributions required to have been made (under the provisions of any
agreements or other governing documents or applicable Laws) with respect to all Saffron Employee Programs, for all periods prior to the Closing Date, either have been made or have been accrued.
(d) No
Saffron Employee Program is subject to Title IV of ERISA and/or Code Section 412, including a Multiemployer Plan and Saffron does not have any liability for
any Employee Program maintained, contributed to, or required to be contributed to by an ERISA Affiliate that is subject to Title IV of ERISA. None of the Saffron Employee Programs provides health care
or any other non-pension benefits to any employees after their employment is terminated (other than as required by part 6 of subtitle B of title I of ERISA or state continuation Laws (whether
or not Saffron subsidizes the premiums for such legally-required coverage) or to which the former employee pays all required premiums).
(e) Each
Saffron Employee Program may be amended, terminated, or otherwise discontinued by Saffron after the Effective Time in accordance with its terms without material
liability to Saffron, the Company or any of their respective Subsidiaries.
(f) Neither
Saffron nor any of its Subsidiaries is a party to any written (i) agreement with any stockholders, director, or employee of Saffron or any of its
Subsidiaries (A) the benefits of which are contingent, or the terms of which are materially altered, upon the occurrence of a transaction involving Saffron or any of its Subsidiaries of the
nature of any of the Contemplated Transactions, (B) providing any guaranteed period of employment or compensation guarantee, or (C) providing severance benefits after the termination of
employment of such director or employee; or (ii) agreement or plan binding Saffron or any of its Subsidiaries, including any stock option plan, stock appreciation right plan, restricted stock
plan, stock purchase plan, or severance benefit plan, any of the benefits of which shall be increased, or the vesting of the benefits of which shall be accelerated, by the occurrence of any of the
Contemplated Transactions or the value of any of the benefits of which shall be calculated on the basis of any of the Contemplated Transactions.
(g) There
is no contract, agreement, plan or arrangement covering any individual that, by itself or collectively, would give rise to any parachute payment subject to
Section 280G of the Code, nor has Saffron made any such payment, and the consummation of the transactions contemplated herein shall
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not
obligate Saffron or any other entity to make any parachute payment that would be subject to Section 280G of the Code.
(h) Each
Saffron Employee Program that is a "nonqualified deferred compensation plan" within the meaning of Section 409A of the Code has been operated and maintained
in compliance with Section 409A of the Code in all material respects. No stock option granted under any Saffron Stock Option Plan has any exercise price that was less than the fair market value
of the underlying stock as of the date the option was granted, or has any feature for the deferral of compensation other than the deferral of recognition of income until the later of exercise or
disposition of such option.
(i) For
purposes of this
Section 3.14
:
(i) An
entity "
maintains
" an Employee Program if such entity sponsors, contributes to, or provides benefits under or through
such Employee Program, or has any obligation (by agreement or under applicable Laws) to contribute to or provide benefits under or through such Employee Program, or if such Employee Program provides
benefits to or otherwise covers or has covered employees of such entity (or their spouses, dependents, or beneficiaries).
(ii) An
entity is an "
ERISA Affiliate
" of Saffron if it would have ever been considered a single employer with Saffron under
ERISA Section 4001(b) or part of the same "controlled group" as Saffron for purposes of ERISA Section 302(d)(3).
3.15 Labor and Employment Matters.
(a) None
of Saffron or any of its Subsidiaries is a party to, or otherwise bound by, any collective bargaining agreement, contract, or other written agreement with a labor
union or labor organization. To the Knowledge of Saffron, neither Saffron nor any of its Subsidiaries is subject to, and during the past three (3) years there has not been, any charge, demand,
petition, organizational campaign, or representation proceeding seeking to compel, require, or demand it to bargain with any labor union or labor organization nor is there pending or threatened any
labor strike or lockout involving Saffron or any of its Subsidiaries.
(b) Except
as would not, individually or in the aggregate, have a Saffron Material Adverse Effect, (i) Saffron and its Subsidiaries are in compliance in all material
respects with all applicable Laws respecting labor, employment, fair employment practices, work safety and health, terms and conditions of employment, wages and hours, including, but not limited to
Title VII of the Civil Rights Act of 1964, as amended, the Equal Pay Act of 1967, as amended, the Age Discrimination in Employment Act of 1967, as amended, the Americans with Disabilities Act, as
amended, the Fair Labor Standards Act, as amended, and its state law equivalents, and the related rules and regulations adopted by those federal agencies responsible for the administration of such
Laws, and other than normal accruals of wages during regular payroll cycles, there are no arrearages in the payment of wages; (ii) neither Saffron nor any of its Subsidiaries is delinquent in
any payments to any employee or to any independent contractors, consultants, temporary employees, leased employees or other servants or agents employed or used with respect to the operation of the
Saffron Business and classified by Saffron or any of its Subsidiaries as other than an employee or compensated other than through wages paid by Saffron or any of its Subsidiaries through its
respective payroll department ("
Saffron Contingent Workers
"), for any wages, salaries, commissions, bonuses, fees or other direct compensation due with
respect to any services performed for it to the date hereof or amounts required to be reimbursed to such employees or Saffron Contingent Workers; (iii) there are no grievances, complaints or
charges with respect to employment or labor matters (including, without limitation, allegations of employment discrimination, retaliation or unfair labor practices) pending or, to the Knowledge of
Saffron, threatened against Saffron or any of its Subsidiaries in any judicial, regulatory or administrative forum, under any private dispute resolution procedure; (iv) none of the employment
policies or practices of Saffron or any of its Subsidiaries is currently being audited or investigated, or to the Knowledge of Saffron, subject to
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imminent
audit or investigation by any Governmental Authority; (v) neither Saffron nor any of its Subsidiaries is, or within the last three (3) years has been, subject to any order,
decree, injunction or judgment by any Governmental Authority or private settlement contract in respect of any labor or employment matters; (vi) Saffron and each of its Subsidiaries is in
material compliance with the requirements of the Immigration Reform Control Act of 1986 and any similar Laws regarding employment of workers who are not citizens of the country in which services are
performed; (vii) all employees of Saffron and each of its Subsidiaries are employed at-will and no such employees are subject to any contract with Saffron or any of its Subsidiaries or any
policy or practice of Saffron or any of its Subsidiaries providing for right of notice of termination of employment or the right to receive severance payments or similar benefits upon the termination
of employment by Saffron or any of its Subsidiaries; (viii) to the extent that any Saffron Contingent Workers are employed, Saffron and each of its Subsidiaries has properly classified and
treated them in accordance with applicable Laws and for purposes of all employee benefit plans and perquisites; (ix) neither Saffron nor any of its Subsidiaries has experienced a "plant
closing," "business closing," or "mass layoff" as defined in the WARN Act or any similar Law affecting any site of employment of Saffron or any of its Subsidiaries or one or more facilities or
operating units within any site of employment or facility of Saffron or any of its Subsidiaries, and, during the ninety (90)-day period preceding the date hereof, no employee has suffered an
"employment loss," as defined in the WARN Act, with respect to Saffron or any of its Subsidiaries; and (x) there are no pending or, to the Knowledge of Saffron, threatened or reasonably
anticipated claims or actions against Saffron or its Subsidiaries under any workers' compensation policy or long-term disability policy.
3.16 Environmental Matters
.
Except as would not, individually or in the aggregate, have a Saffron Material Adverse Effect:
(a) Saffron
and its Subsidiaries are in compliance with all Environmental Laws applicable to their operations and use of the Saffron Leased Real Property;
(b) none
of Saffron or any of its Subsidiaries has generated, transported, treated, stored, or disposed of any Hazardous Material, except in material compliance with all
applicable Environmental Laws, and there has been no Release or threat of Release of any Hazardous Material by Saffron or its Subsidiaries at or on the Saffron Leased Real Property that requires
reporting, investigation or remediation by Saffron or its Subsidiaries pursuant to any Environmental Law;
(c) none
of Saffron or any of its Subsidiaries has (i) received written notice under the citizen suit provisions of any Environmental Law or (ii) been subject
to or, to the Knowledge of Saffron, threatened with any governmental or citizen enforcement action with respect to any Environmental Law; and
(d) to
the Knowledge of Saffron, there are no underground storage tanks, landfills, current or former waste disposal areas or polychlorinated biphenyls at or on the Saffron
Leased Real Property that require reporting, investigation, cleanup, remediation or any other type of response action by Saffron or its Subsidiaries pursuant to any Environmental Law.
3.17 Insurance
. Saffron has made available to the Company accurate and complete
copies of all material insurance policies and all material self-insurance programs and arrangements relating to the business, assets, liabilities and operations of Saffron and each Subsidiary of
Saffron. Each of such insurance policies is in full force and effect and Saffron and each Subsidiary of Saffron are in compliance with the terms thereof. Other than customary end of policy
notifications from insurance carriers, since January 1, 2015, neither Saffron nor any Subsidiary of Saffron has received any notice or other communication regarding any actual or possible:
(i) cancellation or invalidation of any insurance policy; (ii) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy; or
(iii) material adjustment in the amount of the premiums payable with respect to any insurance policy. There is no pending workers' compensation or other claim under or
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based
upon any insurance policy of Saffron or any Subsidiary of Saffron. All information provided to insurance carriers (in applications and otherwise) on behalf of Saffron and each of its
Subsidiaries was, as of the date of such provision, accurate and complete. Saffron and each of its Subsidiaries has provided timely written notice to the appropriate insurance carrier(s) of each Legal
Proceeding pending or threatened in writing against Saffron or any Subsidiary of Saffron, and no such carrier has issued a denial of coverage or a reservation of rights with respect to any such Legal
Proceeding, or informed Saffron or any Subsidiary of Saffron of its intent to do so.
3.18 Books and Records
.
Each of the minute and record books of Saffron contains complete and accurate minutes of all meetings of, and copies of all bylaws and resolutions passed by, or consented to in writing
by, the directors (and any committees thereof) and stockholders of Saffron, since January 1, 2012 and which are required to be maintained in such books under applicable Laws; all such meetings
were duly called and held and all such bylaws and resolutions were duly passed or enacted. Each of the stock certificate books, registers of stockholders and other corporate registers of Saffron
comply in all material respects with the provisions of all applicable Laws and are complete and accurate in all material respects.
3.19 Government Programs
.
No agreements, loans, funding arrangements or assistance programs are outstanding in favor of Saffron or any of its Subsidiaries from any Governmental Authority, and, to the Knowledge of
Saffron, no basis exists for any Governmental Authority to seek payment or repayment from Saffron or any of its Subsidiaries of any amount or benefit received, or to seek performance of any obligation
of Saffron or any of its Subsidiaries, under any such program.
3.20 Transactions with Affiliates
.
Except as set forth in the Saffron SEC Reports filed prior to the date of this Agreement, since the date of Saffron's last proxy statement filed in 2015 with the SEC, no event has
occurred that would be required to be reported by Saffron pursuant to Item 404 of Regulation S-K promulgated by the SEC.
Section 3.20
of the Saffron Disclosure Schedule identifies each
Person who is (or who may be deemed to be) an "affiliate" (as that term is used
in Rule 12b-2 under the Exchange Act) of Saffron as of the date of this Agreement.
3.21 Legal Proceedings; Orders.
(a) Except
as set forth in
Section 3.21
of the Saffron Disclosure Schedule, there is no pending in writing Legal
Proceeding, and (to the Knowledge of Saffron) no Person has threatened in writing to commence any Legal Proceeding: (i) that involves Saffron, any Subsidiary of Saffron or any director or
officer of Saffron (in his or her capacity as such) or any of the material assets owned or used by Saffron and/or any Subsidiary; or (ii) that challenges, or that may have the effect of
preventing, delaying, making illegal or otherwise interfering with, the Merger or any of the other Contemplated Transactions. To the Knowledge of Saffron, no event has occurred, and no claim, dispute
or other condition or circumstance exists, that will, or that would reasonably be expected to, give rise to or serve as a basis for the commencement of any such Legal Proceeding. With regard to any
Legal Proceeding set forth on
Section 3.21
of the Saffron Disclosure Schedule, Saffron has provided the Company or its counsel all pleadings and
material written correspondence related to such Legal Proceeding, all insurance policies and material written correspondence with brokers and insurers related to such Legal Proceedings and other
information material to an assessment of such Legal Proceeding. Saffron has an insurance policy or policies that is expected to cover such Legal Proceeding and has complied with the requirements of
such insurance policy or policies to obtain coverage with respect to such Legal Proceeding under such insurance policy or policies.
(b) There
is no order, writ, injunction, judgment or decree to which Saffron or any Subsidiary of Saffron, or any of the assets owned or used by Saffron or any Subsidiary of
Saffron, is subject. To the Knowledge of Saffron, no officer or other key employee of Saffron or any Subsidiary of Saffron is subject to any order, writ, injunction, judgment or decree that prohibits
such officer or other employee from engaging in or continuing any conduct, activity or practice relating to the Saffron Business or to any material assets owned or used by Saffron or any Subsidiary of
Saffron.
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3.22 Illegal Payments
.
None of Saffron or any of its Subsidiaries (including any of its respective officers or directors) has taken or failed to take any action which would cause it to be in material violation
of the Foreign Corrupt Practices Act of 1977, the U.K. Anti-Bribery Act of 2010, the Unfair Competition Prevention Act of Japan or any similar anti-bribery or anti-corruption Law of any similar Law of
any other jurisdiction, in each case as amended, or any rules or regulations thereunder. None of Saffron or any of its Subsidiaries or, to the Knowledge of Saffron, any third party acting on behalf of
Saffron or any of its Subsidiaries, has offered, paid, promised to pay, or authorized, or will offer, pay, promise to pay, or authorize, directly or indirectly, the giving of money or anything of
value to any Official, or to any other Person while knowing or being aware of a high probability that all or a portion of such money or thing of value will be offered, given or promised, directly or
indirectly, to any Official, for the purpose of: (i) influencing any act or decision of such Official in his, her or its official capacity, including a decision to fail to perform his, her or
its official duties or functions; or (ii) inducing such Official to use his, her or its influence with any Governmental Authority to affect or influence any act or decision of such Governmental
Authority, or to obtain an improper advantage in order to assist Saffron, any of its Subsidiaries or any other Person in obtaining or retaining business for or with, or directing business to, Saffron
or any of its Subsidiaries.
3.23 Inapplicability of Anti-takeover Statutes
.
The Boards of Directors of Saffron and Merger Sub have taken and will take all actions necessary to ensure that the restrictions applicable to business combinations contained in
Section 203 of the DGCL are, and will be, inapplicable to the execution, delivery and performance of this Agreement and the Saffron Voting Agreements and to the consummation of the Merger and
the other Contemplated Transactions. No other state takeover statute or similar Law applies or purports to apply to the Merger, this Agreement, the Saffron Voting Agreements or any of the other
Contemplated Transactions.
3.24 Vote Required
.
The affirmative vote of (i) the holders of a majority of the shares of Saffron Common Stock having voting power representing a majority of the outstanding Common Stock and
(ii) the holders of a majority of the votes properly cast at the Saffron Stockholder Meeting are the only votes of the holders of any class or series of Saffron's capital stock necessary to
approve the Saffron Stockholder Proposals (the "
Saffron Stockholder Approval
").
3.25 No Financial Advisor
.
Except as set forth on
Section 3.25
of the Saffron Disclosure Schedule, no broker, finder or investment banker is entitled to any
brokerage fee, finder's fee, opinion fee, success fee, transaction fee or other fee or commission in connection with the Merger or any of the other Contemplated Transactions based upon arrangements
made by or on behalf of Saffron or any Subsidiary of Saffron.
3.26 Disclosure; Saffron Information
.
The information relating to Saffron or its Subsidiaries to be contained in the Proxy Statement will not, on the date the Proxy Statement is first mailed to Saffron Stockholders or at the
time of the Saffron Stockholder Meeting, contain any untrue statement of any material fact, or omit to state any material fact required to be stated therein or necessary in order to make the
statements therein not false or misleading at the time and in light of the circumstances under which such statement is made. The Proxy Statement will comply in all material respects as to form with
the requirements of the Exchange Act and the rules and regulations thereunder. Notwithstanding the foregoing, no representation is made by Saffron or Merger Sub with respect to the information that
has been or will be supplied by the Company, any of its Subsidiaries or any of their respective Representatives for inclusion in the Proxy Statement.
Section 4. CERTAIN COVENANTS OF THE PARTIES
4.1 Access and Investigation
.
Subject to the terms of the Confidentiality Agreement which the Parties agree will continue in full force following the date of this Agreement, during the period commencing on the date
of this Agreement and ending at the earlier of the date of termination of this Agreement and the Effective Time (the "
Pre-Closing Period
"), upon
reasonable notice, each Party
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shall,
and shall use commercially reasonable efforts to cause such Party's Representatives to: (a) provide the other Party and such other Party's Representatives with reasonable access during
normal business hours to such Party's Representatives, personnel and assets and to all existing books, records, Tax Returns, work papers and other documents and information relating to such Party and
its Subsidiaries; (b) provide the other Party and such other Party's Representatives with such copies of the existing books, records, Tax Returns, work papers, product data, and other documents
and information relating to such Party and its Subsidiaries, and with such additional financial, operating and other data and information regarding such Party and its Subsidiaries as the other Party
may reasonably request; and (c) permit the other Party's officers and other employees to meet, upon reasonable notice and during normal business hours, with the chief financial officer and
other officers and managers of such Party responsible for such Party's financial statements and the internal controls of such Party to discuss such matters as the other Party may deem necessary or
appropriate in order to enable the other Party to satisfy its obligations under the Sarbanes-Oxley Act and the rules and regulations relating thereto. Without limiting the generality of any of the
foregoing, during the Pre-Closing Period, each Party shall promptly make available to the other Party with copies of:
(i) the
unaudited monthly consolidated balance sheets of such Party as of the end of each calendar month and the related unaudited monthly consolidated statements of
operations, statements of stockholders' equity and statements of cash flows for such calendar month, which shall be delivered within thirty (30) days after the end of such calendar month, or
such longer periods as the Parties may agree to in writing;
(ii) all
material operating and financial reports prepared by such Party for its senior management, including sales forecasts, marketing plans, development plans, discount
reports, write-off reports, hiring reports and capital expenditure reports prepared for its management;
(iii) any
written materials or communications sent by or on behalf of a Party to all of its stockholders;
(iv) any
material notice, document or other communication sent by or on behalf of a Party to any party to any Saffron Material Contract or Company Material Contract, as
applicable, or sent to a Party by any party to any Saffron Material Contract or Company Material Contract, as applicable (other than any communication that relates solely to routine commercial
transactions between such Party and the other party to any such Saffron Material Contract or Company Material Contract, as applicable, and that is of the type sent in the Ordinary Course of Business);
(v) any
notice, report or other document filed with or otherwise furnished, submitted or sent to any Governmental Authority on behalf of a Party in connection with the
Merger or any of the Contemplated Transactions;
(vi) any
non-privileged notice, document or other communication sent by or on behalf of, or sent to, a Party relating to any pending or threatened Legal Proceeding involving
or affecting such Party; and
(vii) any
material notice, report or other document received by a Party from any Governmental Authority.
Notwithstanding
the foregoing, any Party may restrict the foregoing access (A) to the extent that any Law applicable to such party requires such Party to restrict or prohibit
access to any such properties or information or as may be necessary to preserve the attorney-client privilege under any circumstances in which such privilege may be jeopardized by such disclosure or
access or (B) to the extent that such Party reasonably believes that allowing such access or furnishing such information would otherwise result in the disclosure of any trade secrets of third
parties or violate any obligations existing on the date hereof with respect to confidentiality to any third party or otherwise breach, contravene or violate any effective Contract existing on the date
hereof.
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4.2 Operation of Saffron's Business.
(a) Except
as set forth on
Section 4.2
of the Saffron Disclosure Schedule, during the Pre-Closing Period:
(i) Saffron shall conduct its business and operations: (A) in the Ordinary Course of Business; and (B) in compliance with all applicable Laws and the requirements of all Contracts
that constitute Saffron Material Contracts; and (ii) Saffron shall promptly notify the Company of: (A) any notice or other communication from any Person alleging that the consent of such
Person is or may be required in connection with any of the Contemplated Transactions; and (B) any Legal Proceeding against, relating to, involving or otherwise affecting Saffron that is
commenced, or, to the Knowledge of Saffron, threatened in writing against, Saffron after the date of this Agreement.
(b) During
the Pre-Closing Period, Saffron shall promptly notify the Company in writing, by delivering an updated Saffron Disclosure Schedule, of: (i) the discovery
by Saffron of any event, condition, fact or circumstance that occurred or existed on or prior to the date of this Agreement and that caused or constitutes a material inaccuracy in any representation
or warranty made by Saffron in this Agreement; (ii) any event, condition, fact or circumstance that occurs, arises or exists after the date of this Agreement and that would cause or constitute
a material inaccuracy in any representation or warranty made by Saffron in this Agreement if: (A) such representation or warranty had been made as of the time of the occurrence, existence or
discovery of such event, condition, fact or circumstance; or (B) such event, condition, fact or circumstance had occurred, arisen or existed on or prior to the date of this Agreement;
(iii) any material breach of any covenant or obligation of Saffron; and (iv) any event, condition, fact or circumstance that could reasonably be expected to make the timely satisfaction
of any of the conditions set forth in
Section 6
,
Section 7
and
Section 8
impossible or
materially less likely. Without limiting the generality of the foregoing, Saffron shall promptly advise the Company in
writing of any Legal Proceeding or material, written claim threatened with respect Saffron. No notification given to the Company pursuant to this
Section 4.2(b)
shall change, limit or otherwise
affect any of the representations, warranties, covenants or obligations of Saffron contained in
this Agreement or the Saffron Disclosure Schedule for purposes of
Section 8.1
.
4.3 Operation of the Company's Business.
(a) Except
as set forth on
Section 4.3
of the Company Disclosure Schedule, during the Pre-Closing Period:
(i) the Company shall conduct its business and operations: (A) in the Ordinary Course of Business; and (B) in compliance with all applicable Laws and the requirements of all
Contracts that constitute Company Material Contracts; (ii) the Company shall use commercially reasonable efforts preserve intact its current business organization, keep available the services
of its current key employees, officers and other employees and maintain its relations and goodwill with all suppliers, customers, landlords, creditors, licensors, licensees, employees and other
Persons having business relationships with the Company; and (iii) the Company shall promptly notify Saffron of: (A) any notice or other communication from any Person alleging that the
consent of such Person is or may be required in connection with any of the Contemplated Transactions; and (B) any Legal Proceeding against, relating to, involving or otherwise affecting the
Company that is commenced, or, to the Knowledge of the Company, threatened against, the Company.
(b) During
the Pre-Closing Period, the Company shall promptly notify Saffron in writing, by delivery of an updated Company Disclosure Schedule, of: (i) the discovery
by the Company of any event, condition, fact or circumstance that occurred or existed on or prior to the date of this Agreement and that caused or constitutes a material inaccuracy in any
representation or warranty made by the Company in this Agreement; (ii) any event, condition, fact or circumstance that occurs, arises or exists after the date of this Agreement and that would
cause or constitute a material inaccuracy in any representation or warranty made by the Company in this Agreement if: (A) such representation or warranty had been made as of the time of the
occurrence, existence or discovery of such event, condition, fact or circumstance; or (B) such event, condition, fact or circumstance had occurred, arisen
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or
existed on or prior to the date of this Agreement; (iii) any material breach of any covenant or obligation of the Company; and (iv) any event, condition, fact or circumstance that
could reasonably be expected to make the timely satisfaction of any of the conditions set forth in
Section 6
,
Section 7
and
Section 8
impossible or materially less likely. Without limiting the
generality of the foregoing, the Company shall promptly advise Saffron in writing of any Legal Proceeding or material, written claim threatened in writing with respect to the Company. No notification
given to Saffron pursuant to this
Section 4.3(b)
shall change, limit or otherwise affect any of the representations, warranties, covenants or
obligations of the Company contained in this Agreement or the Company Disclosure Schedule for purposes of
Section 7.1
.
(c)
Section 4.3(c)
of the Company Disclosure Schedule sets forth a high-level operating budget for the Company for the
Pre-Closing Period. The Company shall use commercially reasonable efforts to apply the proceeds of the Company Private Placement as specified therein.
4.4 Negative Obligations.
(a) Except
(i) as expressly required by this Agreement, (ii) as set forth in
Section 4.4(a)
of the
Saffron Disclosure Schedule or (iii) with the prior written consent of the Company, at all times during the Pre-Closing Period, Saffron shall not, nor shall it cause or permit any Subsidiary of
Saffron to, do any of the following:
(i) declare,
accrue, set aside or pay any dividend or make any other distribution in respect of any shares of capital stock; or repurchase, redeem or otherwise reacquire
any shares of capital stock or other securities (except for shares of Saffron Common Stock from terminated employees of Saffron);
(ii) except
for contractual commitments in place at the time of this Agreement and disclosed in
Section 4.4(a)(ii)
of
the Saffron Disclosure Schedule, and other than as contemplated by the Contemplated Transactions, sell, issue or grant, or authorize the issuance of: (i) any capital stock or other security
(except for Saffron Common Stock issued upon the valid exercise of outstanding Saffron Stock Options); (ii) any option, warrant or right to acquire any capital stock or any other security; or
(iii) any instrument convertible into or exchangeable for any capital stock or other security;
(iii) amend
the certificate of incorporation, bylaws or other charter or organizational documents of Saffron or any Subsidiary of Saffron, or effect or be a party to any
merger, consolidation, share exchange, business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction except as related to the Contemplated
Transactions;
(iv) form
any new Subsidiary or acquire any equity interest or other interest in any other Person;
(v) other
than in the Ordinary Course of Business, lend money to any Person; incur or guarantee any Indebtedness for borrowed money; issue or sell any debt securities or
options, warrants, calls or other rights to acquire any debt securities; or guarantee any debt securities of others;
(vi) other
than in the Ordinary Course of Business, (A) adopt, establish or enter into any Saffron Employee Program; (B) cause or permit any Saffron Employee
Program to be amended other than as required by Law or in order to make amendments for the purposes of Section 409A of the Code, subject to prior review and approval (with such approval not to
be unreasonably withheld) by the Company; (C) hire any new employee or consultant, (D) grant, make or pay any severance, bonus or profit-sharing or similar payment to, or increase the
amount of the wages,
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salary,
commissions, fringe benefits or other compensation or remuneration payable to, any of its directors, employees or consultants;
(vii) acquire
any material asset nor sell, lease or otherwise irrevocably dispose of any of its material assets or properties, nor grant any Encumbrance with respect to such
assets or properties, except in the Ordinary Course of Business;
(viii) make,
change or revoke any material Tax election; file any material amendment to any Tax Return; adopt or change any accounting method in respect of Taxes; change any
annual Tax accounting period; enter into any Tax allocation agreement, Tax sharing agreement or Tax indemnity agreement, other than commercial contracts entered into in the Ordinary Course of Business
and the primary purpose of which does not relate to Taxes; enter into any closing agreement with respect to any material Tax Liability; settle or compromise any claim, notice, audit report or
assessment in respect of any material Tax Liability; apply for or enter into any ruling from any Tax authority with respect to Taxes; surrender any right to claim a refund of a material amount of
Taxes; or consent to any extension or waiver of the statute of limitations period applicable to any material Tax claim or assessment;
(ix) enter
into, amend or terminate any Saffron Material Contract;
(x) commence
a lawsuit other than (A) for routine collection of bills, (B) in such cases as Saffron in good faith determines that failure to commence such
lawsuit would result in the material impairment of a valuable aspect of Saffron's and/or any Subsidiary of Saffron's business or (C) for a breach of this Agreement;
(xi) fail
to make any material payment with respect to any of Saffron's accounts payable or Indebtedness in a timely manner in accordance with the terms thereof and
consistent with past practices;
(xii) except
as permitted by
Section 4.5(b)
, participate in negotiations for, or initiate, solicit, seek or knowingly
encourage or support, any inquiries, proposals or offers relating to, any potential transaction or series of transactions involving any acquisition of an equity interest in any Person, or the purchase
or license of any assets or properties; or
(xiii) agree
to take, take or permit any Subsidiary of Saffron to take or agree to take, any of the actions specified in clauses (i) through (xii) of this
Section 4.4(a)
.
(b) Except
(i) as expressly required by this Agreement, (ii) as set forth in
Section 4.4(b)
of the
Company Disclosure Schedule or (iii) with the prior written consent of Saffron, at all times during the Pre-Closing Period, the Company shall not do any of the following:
(i) declare,
accrue, set aside or pay any dividend or make any other distribution in respect of any shares of capital stock; or repurchase, redeem or otherwise reacquire
any shares of capital stock or other securities (except for shares of Company Common Stock from terminated employees of the Company);
(ii) amend
the Company Charter, Company Bylaws or other charter or organizational documents of the Company, or effect or be a party to any merger, consolidation, share
exchange, business combination, recapitalization, reclassification of shares, stock split, reverse stock split or similar transaction except as related to the Contemplated Transactions or the Company
Private Placement;
(iii) except
for contractual commitments in place at the time of this Agreement and disclosed in
Section 4.4(b)(iii)
of the Company Disclosure Schedule, sell, issue or grant, or authorize the issuance of, or make any commitments to do any of the foregoing, other than as contemplated by the Contemplated Transactions:
(i) any capital stock or other security; (ii) any option, warrant or
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right
to acquire any capital stock or any other security; or (iii) any instrument convertible into or exchangeable for any capital stock or other security;
(iv) form
any Subsidiary or acquire any equity interest or other interest in any other Person;
(v) other
than in the Ordinary Course of Business, lend money to any Person; incur or guarantee any Indebtedness for borrowed money; issue or sell any debt securities or
options, warrants, calls or other rights to acquire any debt securities; guarantee any debt securities of others; or make any capital expenditure or commitment in excess of $100,000;
(vi) other
than in the Ordinary Course of Business, and in observance of common practice for a similarly-situated company: (i) adopt, establish or enter into any
Company Employee Program; (ii) cause or permit any Company Employee Program to be amended other than as required by Law; or (iii) pay any bonus or made any profit-sharing or similar
payment to, or increase the amount of the wages, salary, commissions, fringe benefits or other compensation or remuneration payable to, any of its directors, officers or employees;
(vii) acquire
any material asset nor sell, lease or otherwise irrevocably dispose of any of its assets or properties, nor grant any Encumbrance with respect to such assets
or properties, except in the Ordinary Course of Business;
(viii) make,
change or revoke any material Tax election; file any material amendment to any Tax Return; adopt or change any accounting method in respect of Taxes; change any
annual Tax accounting period; enter into any Tax allocation agreement, Tax sharing agreement or Tax indemnity agreement, other than commercial contracts entered into in the Ordinary Course of Business
and the primary purpose of which does not relate to Taxes; enter into any closing agreement with respect to any material Tax Liability; settle or compromise any claim, notice, audit report or
assessment in respect of any material Tax Liability; apply for or enter into any ruling from any Tax authority with respect to Taxes; surrender any right to claim a refund of a material amount of
Taxes; or consent to any extension or waiver of the statute of limitations period applicable to any material Tax claim or assessment;
(ix) enter
into, amend or terminate any Company Material Contract;
(x) commence
a lawsuit other than (A) for routine collection of bills, (B) in such cases as the Company in good faith determines that failure to commence such
lawsuit would result in the material impairment of a valuable aspect of the Company's business or (C) for a breach of this Agreement;
(xi) fail
to make any material payment with respect to any of the Company's accounts payable or Indebtedness in a timely manner in accordance with the terms thereof and
consistent with past practices; or
(xii) agree
to take or take any of the actions specified in clauses (i) through (xi) of this
Section 4.4(b)
.
4.5 Mutual Non-Solicitation.
(a)
No Solicitation by the Company
.
(i) Except
as permitted by this
Section 4.5(a)
, during the Pre-Closing Period, none of the Company or any
Representative of the Company shall directly or indirectly (A) initiate, solicit, seek or knowingly encourage or support any inquiries, proposals or offers that constitute or may reasonably be
expected to lead to, a Company Acquisition Proposal (as defined below), (B) engage or participate in, or knowingly facilitate, any discussions or negotiations regarding, or furnish any
nonpublic information to any Person in connection with, any inquiries, proposals or offers that constitute, or may reasonably be expected to lead to, a Company Acquisition Proposal (other than,
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solely
in response to an unsolicited inquiry, to refer the inquiring person to this
Section 4.5
and to limit its conversation or other
communication exclusively to such referral), or (C) enter into any letter of intent, agreement in principle or other similar type of agreement relating to a Company Acquisition Proposal, or
enter into any agreement or agreement in principle requiring Company to abandon, terminate or fail to consummate the transactions contemplated hereby or resolve, propose or agree to do any of the
foregoing;
provided
,
however
, that prior to the earlier of the time that the Company Stockholders adopt
and approve this Agreement pursuant to the Company Stockholder Written Consent or the termination of this Agreement in accordance with
Section 9
,
the Company may take the
following actions in response to an unsolicited bona fide written Company Acquisition Proposal received after the date hereof that the Board of Directors of the Company has determined, in good faith,
after consultation with its outside counsel and financial advisors, constitutes, or would reasonably be expected to lead to, a Company Superior Offer: (1) furnish nonpublic information
regarding Company to the third party making the Company Acquisition Proposal (a "
Company Qualified Bidder
") and (2) engage in discussions or
negotiations with the Company Qualified Bidder and its representatives with respect to such Company Acquisition Proposal;
provided
that (w) the
Company receives from the Company Qualified Bidder an executed confidentiality agreement the terms of which are not less restrictive to such Person than those contained in the Confidentiality
Agreement, and containing additional provisions that expressly permit the Company to comply with the terms of this
Section 4.5
(a
"
Company Acceptable Confidentiality Agreement
") (a copy of such Company Acceptable Confidentiality Agreement shall promptly, and in any event within
twenty-four (24) hours, be provided to Saffron for informational purposes only), (x) the Company contemporaneously supplies to Saffron any such nonpublic information or access to any
such nonpublic information to the extent it has not been previously provided or made available to Saffron, (y) the Company has not breached this
Section 4.5
, and (z) the Board of
Directors of the Company determines in good faith, after consultation with its outside legal counsel and
financial advisors, that taking such actions would be required to comply with the fiduciary duties of the Board of Directors of the Company under applicable Laws.
(ii) For
purposes of this Agreement,
(A) "
Company Acquisition Proposal
" means any proposal, indication of interest or offer for (i) a merger, tender offer,
recapitalization, reorganization, business combination, share exchange, arrangement or consolidation, or any similar transaction involving the Company, (ii) a sale, lease, exchange, mortgage,
pledge, transfer or other acquisition of fifteen percent (15%) or more of the assets of the Company in one or a series of related transactions, or (iii) a purchase, tender offer or other
acquisition (including by way of merger, consolidation, share exchange, arrangement, consolidation or otherwise) of beneficial ownership (the term "beneficial ownership" for purposes of this Agreement
having the meaning assigned thereto in Section 13(d) of the Exchange Act and the rules and regulations thereunder) of securities representing fifteen percent (15%) or more of the voting power
of the Company (including securities of the Company currently beneficially owned by such Person);
provided
,
however
, that the term "Company Acquisition
Proposal" shall not include the Merger or the other transactions contemplated by this Agreement; and
(B) "
Company Superior Offer
" shall mean an unsolicited bona fide Company Acquisition Proposal (with all references to
"fifteen percent (15%)" in the definition of Company Acquisition Proposal being treated as references to "one hundred percent (100%)" for these purposes) made by a third party that the Board of
Directors of the Company determines in good faith, after consultation with its outside legal counsel and financial advisor, and after taking into account all financial, legal, regulatory, and other
aspects of such Company Acquisition Proposal, (1) is more favorable from a financial point of view to the Company
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Stockholders
than as provided hereunder (including any changes to the terms of this Agreement proposed by Saffron in response to such Company Superior Offer pursuant to and in accordance with
Section 4.5(a)(iv)
,
or otherwise), (2) is not subject to any financing condition (and if financing is required, such financing is then
fully committed to the third party), (3) is reasonably capable of being completed on the terms proposed without unreasonable delay and (4) includes termination rights exercisable by the
Company on terms no less favorable to the Company than the terms set forth in this Agreement, all from a third party capable of performing such terms.
(iii) Except
as otherwise provided in
Section 4.5(a)(iv)
, neither the Board of Directors of the Company nor any
committee of the Board of Directors of the Company shall fail to make, withhold, withdraw, amend, change or publicly propose to withhold, withdraw, amend or change in a manner adverse to Saffron, the
Company Board Recommendation, knowingly make any public statement inconsistent with such recommendation, fail to recommend against acceptance of a tender offer within ten (10) Business Days
after commencement, propose publicly to approve, adopt or recommend any Company Acquisition Proposal, or make any public statement inconsistent with its recommendation (any action described in this
sentence being referred to as a "
Company Change of Recommendation
").
(iv) Nothing
in this
Section 4.5
shall prohibit the Board of Directors of the Company from making any disclosure to
the Company Stockholders, if, in the good faith judgment of the Board of Directors of the Company, after consultation with its outside legal counsel, such disclosure would be required to comply with
its fiduciary duties under applicable Law.
(b)
No Solicitation by Saffron
.
(i) Except
as permitted by this Section 4.5(b), during the Pre-Closing Period, none of Saffron, its Subsidiaries or any Representative of Saffron or any of its
Subsidiaries shall directly or indirectly (A) initiate, solicit, seek or knowingly encourage or support any inquiries, proposals or offers that constitute or may reasonably be expected to lead
to, a Saffron Acquisition Proposal (as defined below), (B) engage or participate in, or knowingly facilitate, any discussions or negotiations regarding, or furnish any nonpublic information to
any Person in connection with, any inquiries, proposals or offers that constitute, or may reasonably be expected to lead to, a Saffron Acquisition Proposal, or (C) enter into any letter of
intent, agreement in principle or other similar type of agreement relating to a Saffron Acquisition Proposal, or enter into any agreement or agreement in principle requiring Saffron to abandon,
terminate or fail to consummate the transactions contemplated hereby or resolve, propose or agree to do any of the foregoing (other than, solely in response to an unsolicited inquiry, to refer the
inquiring person to this
Section 4.5
and to limit its conversation or other communication exclusively to such referral);
provided
,
however
, that prior to the earlier of the approval of the Saffron Stockholder
Proposals at the Saffron Stockholder Meeting or the termination of this Agreement in accordance with
Section 9
, Saffron may take the following
actions in response to an unsolicited bona fide written Saffron Acquisition Proposal received after the date hereof that the Board of Directors of Saffron has determined, in good faith, after
consultation with its outside counsel and financial advisors, constitutes, or would reasonably be expected to lead to, a Saffron Superior Offer: (1) furnish nonpublic information regarding
Saffron to the third party making the Saffron Acquisition Proposal (a "
Saffron Qualified Bidder
"); and (2) engage in discussions or negotiations
with the Saffron Qualified Bidder and its representatives with respect to such Saffron Acquisition Proposal;
provided
that (w) Saffron receives
from the Saffron Qualified Bidder an executed confidentiality agreement the terms of which are not less restrictive to such Person than those contained in the Confidentiality Agreement, and containing
additional provisions that expressly permit Saffron to comply with the terms of this
Section 4.5
(a "
Saffron Acceptable
Confidentiality Agreement
") (a copy of such Saffron Acceptable Confidentiality Agreement shall promptly, and in any event within twenty-four
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(24) hours,
be provided to the Company for informational purposes only), (x) Saffron contemporaneously supplies to the Company any such nonpublic information or access to any such
nonpublic information to the extent it has not been previously provided or made available to the Company, (y) Saffron has not breached this
Section 4.5
, and (z) the Board of Directors of
Saffron determines in good faith, after consultation with its outside legal counsel, that
taking such actions would be required to comply with the fiduciary duties of the Board of Directors of Saffron under applicable Laws.
(ii) For
purposes of this Agreement,
(A) "
Saffron Acquisition Proposal
" means any proposal, indication of interest or offer for (i) a merger, tender offer,
recapitalization, reorganization, business combination, share exchange, arrangement or consolidation, or any similar transaction involving Saffron or its Subsidiaries, (ii) a sale, lease,
exchange, mortgage, pledge, transfer or other acquisition of fifteen percent (15%) or more of the assets of Saffron and its Subsidiaries, taken as a whole, in one or a series of related transactions,
or (iii) a purchase, tender offer or other acquisition (including by way of merger, consolidation, share exchange, arrangement, consolidation or otherwise) of beneficial ownership (the term
"beneficial ownership" for purposes of this Agreement having the meaning assigned thereto in Section 13(d) of the Exchange Act and the rules and regulations thereunder) of securities
representing fifteen percent (15%) or more of the voting power of Saffron (including securities of Saffron currently beneficially owned by such Person);
provided
,
however
, that the term "Saffron Acquisition Proposal" shall not include the Merger or the
other transactions contemplated by this Agreement, the transactions set forth on
Schedule 4.5(b)(ii)
; and
(B) "
Saffron Superior Offer
" shall mean an unsolicited bona fide Saffron Acquisition Proposal (with all references to
"fifteen percent (15%)" in the definition of Saffron Acquisition Proposal being treated as references to "one hundred (100%)" for these purposes) made by a third party that the Board of Directors of
Saffron determines in good faith, after consultation with its outside legal counsel and financial advisor, and after taking into account all financial, legal, regulatory, and other aspects of such
Saffron Acquisition Proposal, (1) is more favorable from a financial point of view to the Saffron Stockholders than as provided hereunder (including any changes to the terms of this Agreement
proposed by Company in response to such Saffron Superior Offer pursuant to and in accordance with
Section 4.5(b)(v)
or otherwise), (2) is
not subject to any financing condition (and if financing is required, such financing is then fully committed to the third party), (3) is reasonably capable of being completed on the terms
proposed without unreasonable delay and (4) includes termination rights exercisable by Saffron on terms no less favorable to Saffron than the terms set forth in this Agreement, all from a third
party capable of performing such terms.
(iii) Except
as otherwise provided in
Section 4.5(b)(iv)
, neither the Board of Directors of Saffron nor any committee
of the Board of Directors of Saffron shall fail to make, withhold, withdraw, amend, change or publicly propose to withhold, withdraw, amend or change in a manner adverse to Company, the Saffron
Recommendation, knowingly make any public statement inconsistent with such recommendation, fail to recommend against acceptance of a tender offer within ten (10) Business Days after
commencement, propose publicly to approve, adopt or recommend any Saffron Acquisition Proposal, or make any public statement inconsistent with its recommendation (any action described in this sentence
being referred to as a "
Saffron Change of Recommendation
").
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(iv) Notwithstanding
the foregoing, provided that Saffron shall not have breached in a material respect its obligations under Section 4.5(b), the Board of Directors
of Saffron may effect a Saffron Change of Recommendation if:
(A) the
Board of Directors of Saffron determines in good faith, after consultation with outside legal counsel and financial advisors, that a Saffron Change of Recommendation
is required in order to comply with its fiduciary duties under applicable Laws either based upon (1) an Intervening Event or (2) receipt of a Saffron Acquisition Proposal that the Board
of Directors of Saffron determines in good faith, after consultation with outside legal counsel and financial advisors, constitutes a Saffron Superior Offer, but in each case only at a time that is
prior to the approval of the Saffron Stockholder Proposals at the Saffron Stockholder Meeting and is after 11:59 pm, New York City time, on the third Business Day following the Company's receipt of
written notice (a "
Saffron Change of Recommendation Notice
") advising the Company that the Board of Directors of Saffron desires to effect a Saffron
Change of Recommendation (and the manner and timing in which it intends to do so, and in the case of an Intervening Event, specifying the reasons therefor in reasonable detail) (such three Business
Day period, the "
Notice Period
"); and
(B) Saffron
provides the Company with a reasonable opportunity to make adjustments in the terms and conditions of this Agreement and negotiates in good faith with the
Company with respect thereto during the Notice Period, in each case as would enable the Board of Directors of Saffron or committee thereof to conclude that (1) the Intervening Event is no
longer a basis for any Saffron Change of Recommendation or (2) the Saffron Acquisition Proposal that was determined to be a Saffron Superior Offer is no longer a Saffron Superior Offer.
Any material changes to the financial terms or any material change to other material terms of such Saffron Superior Offer occurring prior to the Board of
Directors of Saffron's effecting a Saffron Change of Recommendation pursuant to this
Section 4.5(b)(iv)
shall require Saffron to provide to the
Company a new Saffron Change of Recommendation Notice and a new Notice Period and to comply with the requirements of this
Section 4.5(b)(iv)
with
respect to each such Saffron Change of Recommendation Notice, except that the references to the "third Business Day" shall be deemed to be the "second Business Day." Any Saffron Change of
Recommendation shall not change the approval of this Agreement or any other approval of the Board of Directors of Saffron, including in any respect that would have the effect of causing any state
(including Delaware) corporate takeover statute or other similar statute to be applicable to the transactions contemplated hereby or thereby, including the Merger.
(v) Nothing
in this
Section 4.5
shall prohibit Saffron from complying with Rule 14e-2 or Rule 14d-9
promulgated under the Exchange Act with regard to a Saffron Acquisition Proposal, respectively, or from the Board of Directors of Saffron making any disclosure to the Saffron Stockholders if, in the
good faith judgment of the Board of Directors of Saffron, after consultation with its outside legal counsel, that taking such action or making such disclosure would be required to comply with its
fiduciary duties under applicable Laws.
(c) Both
the Company and Saffron shall notify the other no later than twenty-four (24) hours after receipt of any inquiries, discussions, negotiations, proposals or
expressions of interest with respect to a Company Acquisition Proposal or Saffron Acquisition Proposal, respectively, and any such notice shall be made orally and in writing and shall indicate in
reasonable detail the terms and conditions of such proposal, inquiry or contact, including price, and the identity of the offeror. Both the Company and Saffron shall keep the other informed, on a
current basis, of the status and material developments (including any changes to the terms) of such Company Acquisition Proposal or Saffron Acquisition Proposal, respectively.
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(d) The
Company and Saffron shall, and shall cause each of their respective Subsidiaries and their respective Representatives to, immediately cease and cause to be
terminated any and all existing activities, discussions or negotiations with any Person conducted heretofore with respect to, or that may reasonably be expected to lead to, a Company Acquisition
Proposal or Saffron Acquisition Proposal.
Section 5. ADDITIONAL AGREEMENTS OF THE PARTIES
5.1 Disclosure Documents.
(a) As
promptly as practicable after the date of this Agreement, Saffron shall prepare and file with the SEC a proxy statement relating to the Saffron Stockholder Meeting to
be held in connection with the Merger (together with any amendments thereof or supplements thereto, the "
Proxy Statement
"). Each of Saffron and the
Company shall use their commercially reasonable efforts: (i) to cause the Proxy Statement to comply with the applicable rules and regulations promulgated by the SEC; and (ii) to promptly
notify the other of, cooperate with each other with respect to and respond promptly to any comments of the SEC or its staff. Each of Saffron, Merger Sub and the Company shall furnish all information
concerning itself and their Subsidiaries, as applicable, to the other parties as the other parties may reasonably request in connection with such actions and the preparation of the Proxy Statement. As
promptly as practicable after the date of this Agreement, and in no event later than thirty (30) days after the date of this Agreement, the Company shall (i) furnish to Saffron all such
information concerning the Company to be included in the Proxy Statement, and (ii) cooperate with Saffron to file the Proxy Statement with the SEC within such thirty (30) day period.
Saffron shall use commercially reasonable efforts to cause the Proxy Statement to be mailed to its stockholders as promptly as practicable, and in no event later than five (5) Business Days,
following clearance of the Proxy Statement by the SEC. Each of the Company and Saffron shall use commercially reasonable efforts to cause all information that it is responsible for providing for
inclusion in documents filed with the SEC in connection with the Contemplated Transactions to comply as to form and substance in all material respects with the applicable requirements of the
Securities Act and the Exchange Act. If Saffron, Merger Sub or the Company become aware of any event or information that, pursuant to the Securities Act or the Exchange Act, should be disclosed in an
amendment or supplement to the Proxy Statement, as the case may be, then such party, as the case may be, shall promptly inform the other parties thereof and shall cooperate with such other parties in
filing such amendment or supplement with the SEC and, if appropriate, in mailing such amendment or supplement to the Saffron stockholders.
(b) Notwithstanding
anything to the contrary stated above, prior to filing and mailing, as applicable, the Proxy Statement (or any amendment or supplement thereto) or
responding to any comments of the SEC with respect thereto, or making or disseminating any other communication to its stockholders regarding the Contemplated Transactions, Saffron shall provide the
Company a reasonable opportunity to review and comment on such document or response and shall discuss with the Company and include in such document or response, comments reasonably and promptly
proposed by the Company. Saffron will advise the Company, promptly after Saffron receives notice thereof, of the clearance of the Proxy Statement by the SEC or any supplement or amendment has been
filed, of the issuance of any stop order or the suspension of the qualification of Saffron Common Stock for offering or sale in any jurisdiction, of the initiation or threat of any proceeding for any
such purpose, or of any request by the SEC for the amendment or supplement of the Proxy Statement or for additional information.
(c) Within
sixty (60) days following the Closing Date, Saffron will prepare and file with the SEC a registration statement on Form S-3 (or if Form S-3
is not available, such other form as may provide for a resale of the shares of Saffron Common Stock issued pursuant to Section 1.5(a) but with such registration obligations otherwise consistent
with the requirements of this Section 5.1(c)), covering the resale of the shares of Saffron Common Stock issued pursuant to Section 1.5(a) (together with all
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amendments
and supplements thereto, including post-effective amendments, all exhibits thereto and all material incorporated by reference therein, the "
Registration
Statement
"). Saffron will use commercially reasonable efforts to cause the Registration Statement to be declared effective as soon as possible following the filing of the
Registration Statement and be maintained effective until the earliest to occur of: (i) the second anniversary of the date the Registration Statement is first declared effective, or
(ii) the date that all of the shares of Saffron Common Stock issued pursuant to Section 1.5 have actually been sold. For not more than sixty (60) consecutive days or for a total
of not more than one hundred twenty (120) days in any twelve (12) month period, Saffron may suspend the use of any prospectus included in the Registration Statement if Saffron's Board of
Directors determines in good faith that such suspension is necessary to (x) delay the disclosure of material non-public information concerning Saffron, the disclosure of which at the time is
not, in the good faith opinion of Saffron's Board of Directors, in the best interests of Saffron and its stockholders, or (y) amend or supplement the Registration Statement or the related
prospectus so that the Registration Statement or prospectus will not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make
the statements therein, in the case of the prospectus in light of the circumstances under which they were made, not misleading.
5.2 Stockholder Approval.
(a)
Stockholders' Consent
.
(i) During
the Pre-Closing Period, the Company shall take all action necessary in accordance with this Agreement, the DGCL, the Company Charter and the Company Bylaws to
obtain, within twenty-four (24) hours after this Agreement is executed by the Parties, the Company Stockholder Written Consent executed by the Company Minimum Holders and sufficient for the
Company Stockholder Approval in lieu of a meeting pursuant to Section 228 of the DGCL, for purposes of (A) adopting this Agreement and approving the Merger and all other transactions
contemplated hereby, including the conversion of the Company Preferred Stock into Company Common Stock, (B) acknowledging that such adoption and approval of the Merger and the conversion of the
Company Preferred Stock into Company Common Stock given thereby is irrevocable and that such stockholder is aware it may have the right to demand appraisal for its shares pursuant to
Section 262 of the DGCL, a copy of which was attached thereto, and that such stockholder has received and read a copy of Section 262 of the DGCL, and (C) acknowledging that by its
approval of the Merger it is not entitled to appraisal or dissenters' rights with respect to its
shares in connection with the Merger and thereby waives any rights to receive payment of the fair value of its capital stock under the DGCL. Under no circumstances shall the Company assert that any
other approval or consent is necessary by its stockholders to approve the Merger or the conversion of the Company Preferred Stock into Company Common Stock or this Agreement. The Company shall use its
commercially reasonable efforts to obtain the Company Stockholder Written Consent executed by the Company Minimum Holders, sufficient for the Company Stockholder Approval and in compliance with all
applicable Laws, and shall use commercially reasonable efforts to cause such Company Stockholder Written Consent not to be waived or revoked.
(ii) The
Company agrees that (A) the Company's Board of Directors shall unanimously recommend that the holders of Company Common Stock and Company Preferred Stock
take action by written consent to approve the Merger and shall use commercially reasonable efforts to solicit such approval within the timeframe set forth in
Section 5.2(a)(i)
above, (B) the
statement or information provided to the holders of Company Common Stock and Company Preferred Stock
shall include a statement to the effect that the Board of Directors of the Company recommends that the Company's stockholders take action by written consent to approve the Merger (the recommendation
of the Company's Board of Directors that the Company's stockholders approve the Merger being referred to as the "
Company Board Recommendation
"); and
(C) the Company Board Recommendation shall not be withdrawn or modified in a manner adverse to Saffron, and
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no
resolution by the Board of Directors of the Company or any committee thereof to withdraw or modify the Company Board Recommendation in a manner adverse to Saffron shall be adopted or proposed.
(iii) The
Company's obligation to solicit the consent of its stockholders to sign the Company Stockholders Written Consent in accordance with
Section 5.2(a)
shall not be limited or otherwise affected by the
commencement, disclosure, announcement or submission of any Company Superior
Offer or other Company Acquisition Proposal.
(iv) In
connection with the solicitation of the Company Stockholder Written Consent from its stockholders to adopt this Agreement and approve the Merger, the Company shall
furnish to Saffron, as promptly as possible, and in any event within twenty-four (24) hours after this Agreement is executed by the Parties, a copy of such executed Company Stockholder Written
Consent.
(v) Promptly
after the date hereof, and in no case later than ten (10) days after obtaining the Company Stockholder Approval, the Company shall deliver (in any manner
permitted by applicable Laws to each Company Stockholder notice of the Company Stockholders' approval and adoption of this Agreement and the consummation of the Contemplated Transactions, in
compliance with Sections 228(e) and 262 of the DGCL. Thereafter, the Company shall provide to its stockholders who did not execute a Company Stockholders Written Consent applicable and
appropriate notices regarding their appraisal or dissenters' rights under Section 262 of the DGCL, which notice shall comply with all applicable Laws.
(b)
Saffron Stockholder Meeting
.
(i) Saffron
shall take all action necessary in accordance with applicable Laws and the Saffron Charter and Saffron Bylaws to call, give notice of, convene and hold a
meeting of the Saffron Stockholders (the "
Saffron Stockholder Meeting
") to consider and vote on proposals to adopt this Agreement, the issuance of the
shares of Saffron Common Stock by virtue of the Merger and an amendment to the Saffron Charter to effect the Reverse Stock Split (collectively, the "
Saffron Stockholder
Proposals
"). The Saffron Stockholder Meeting shall be held (on a date selected by Saffron in consultation with the Company) as promptly as practicable, and in any event not
later than forty-five (45) days after the date that the definitive Proxy Statement is filed with the SEC. If on the scheduled date of the Saffron Stockholder meeting Saffron has not obtained
the Saffron Stockholder Approvals, Saffron shall have the right to adjourn or postpone the Saffron Stockholder Meeting to a later date or dates, such later date or dates not to exceed thirty
(30) days from the original date that the Saffron Stockholder Meeting was scheduled for the approval of the Saffron Stockholder Proposals.
(ii) Subject
to the provisions of
Section 4.5
hereof, the Board of Directors of Saffron shall recommend that the
Saffron Stockholders approve the Saffron Stockholder Proposals (the "
Saffron Recommendation
") and Saffron shall include such Saffron Recommendation in
the Proxy Statement.
(c) Saffron
shall use its commercially reasonable efforts to solicit from the Saffron Stockholders proxies in favor of the Saffron Stockholder Proposals and shall take all
other action necessary or advisable to secure the Saffron Stockholder Approvals.
5.3 Regulatory Approvals
.
Each Party shall use commercially reasonable efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports and other
documents reasonably required to be filed by such Party with or otherwise submitted by such Party to any Governmental Authority with respect to the Merger and the other Contemplated Transactions, and
to submit promptly any additional information requested by any such Governmental Authority. Without limiting the generality of the foregoing, the Parties shall, promptly after the date of
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this
Agreement, prepare and file any notification or other document required to be filed in connection with the Merger under any applicable foreign Law relating to antitrust or competition matters.
The Company and Saffron shall respond as promptly as is practicable to respond in compliance with: (i) any inquiries or requests received from the Federal Trade Commission or the Department of
Justice for information or documentation; and (ii) any inquiries or requests received from any state attorney general, foreign antitrust or competition authority or other Governmental Authority
in connection with antitrust or competition matters.
5.4 Net Cash Schedule
.
Saffron shall prepare and deliver to the Company three (3) Business Days prior to the Closing, a schedule (the "
Net Cash Schedule
")
setting forth, in reasonable detail, Saffron's good faith estimate of Net Cash to be held by Saffron as of the Closing, together with the work papers and back-up materials used in preparing such Net
Cash Schedule. After delivery of the Net Cash Schedule by Saffron, the Company shall have an opportunity to review the Net Cash Schedule and Saffron shall provide the Company and its Representatives
with access to the books and records, books of account, accountant's work papers, and personnel and accountants of Saffron and its Subsidiaries and shall cause the employees and accountants of Saffron
and its Subsidiaries to cooperate with the Company and its Representatives at reasonable times and upon reasonable notice in connection with their review of such documents and information.
5.5 Indemnification of Officers and Directors.
(a) Saffron
and Merger Sub agree that all rights to indemnification, exculpation or advancement of expenses now existing in favor of, and all limitations on the personal
liability of each present and former director, officer, employee, fiduciary, or agent of Saffron or the Company provided for in the respective organizational documents in effect as of the date hereof,
shall continue to be honored and in full force and effect for a period of six (6) years after the Effective Time;
provided
,
however
, that all rights
to indemnification in respect of any claims asserted or made within such period shall continue until the disposition of such
claim. The certificate of incorporation of the Surviving Corporation will contain provisions with respect to indemnification, exculpation from liability and advancement of expenses that are at least
as favorable as those currently in the Company Charter and Company Bylaws and during such six (6) year period following the Effective Time, Saffron shall not and shall cause the Surviving
Corporation not to amend, repeal or otherwise modify such provisions in any manner that would materially and adversely affect the rights thereunder of individuals who at any time prior to the
Effective Time was a director, officer, employee, fiduciary, or agent of the Company in respect of actions or omissions occurring at or prior to the Effective Time, unless such modification is
required by applicable Laws. From and after the Effective Time, Saffron and the Surviving Corporation also agree, jointly and severally, to indemnify and hold harmless the present and former officers,
directors, employees, fiduciaries and agents of the Company in respect of acts or omissions occurring prior to the Effective Time to the extent (i) provided in any written indemnification
agreements listed in
Section 5.5(a)
of the Company Disclosure Schedule between the Company and such individuals or (ii) required by the
Company Charter or the Company Bylaws, in each case as in effect immediately prior to the Effective Time.
(b) The
Company shall purchase a six-year "tail" policy under the Company's existing directors' and officers' liability insurance policy, with an effective date as of the
Closing.
(c) The
provisions of this
Section 5.5
are intended to be for the benefit of, and shall be enforceable by, each of the
Persons indemnified hereby, and his or her heirs and Representatives, and may not be amended, altered or repealed without the written consent of any such Person affected by such amendment, alteration
or repeal. The provisions in this
Section 5.5
are intended to be in addition to the rights otherwise available to the current directors,
officers, employees, fiduciaries and/or agents of the Company by Laws, charters, bylaws or agreements.
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(d) If
Saffron or the Surviving Corporation or any of the successors or assigns of Saffron or the Surviving Corporation (i) consolidates with or merges into any other
Person and shall not be the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers or conveys all or substantially all of its properties and assets to
any Person, then, and in each such case, to the extent necessary, proper provision shall be made so that the successors and assigns of Saffron or the Surviving Corporation, as the case may be, shall
assume the obligations set forth in this
Section 5.5
.
5.6 Additional Agreements.
(a) Subject
to
Section 5.6(b)
, the Parties shall use commercially reasonable efforts to cause to be taken all actions
necessary to consummate the Merger and make effective the other Contemplated Transactions. Without limiting the generality of the foregoing, but subject to
Section 5.6(b)
, each Party to this
Agreement: (i) shall make all filings and other submissions (if any) and give all notices (if any)
required to be made and given by such Party in connection with the Merger and the other Contemplated Transactions; (ii) shall use commercially reasonable efforts to obtain each consent (if any)
reasonably required to be obtained (pursuant to any applicable Law or Contract, or otherwise) by such Party in connection with the Merger or any of the other Contemplated Transactions or for such
Contract to remain in full force and effect; (iii) shall use commercially reasonable efforts to lift any injunction prohibiting, or any other legal bar to, the Merger or any of the other
Contemplated Transactions; and (iv) shall use commercially reasonable efforts to satisfy the conditions precedent to the consummation of this Agreement.
(b) Notwithstanding
anything to the contrary contained in this Agreement, no Party shall have any obligation under this Agreement: (i) to dispose of or transfer or
cause any of its Subsidiaries to dispose of or transfer any assets; (ii) to discontinue or cause any of its Subsidiaries to discontinue offering any product or service; (iii) to license
or otherwise make available, or cause any of its Subsidiaries to license or otherwise make available to any Person any Intellectual Property; (iv) to hold separate or cause any of its
Subsidiaries to hold separate any assets or operations (either before or after the Closing Date); (v) to make or cause any of its Subsidiaries to make any commitment (to any Governmental
Authority or otherwise) regarding its future operations; or (vi) to contest any Legal Proceeding or any order, writ, injunction or decree relating to the Merger or any of the other Contemplated
Transactions if such Party determines in good faith that contesting such Legal Proceeding or order, writ, injunction or decree might not be advisable.
5.7 Disclosure
. Without limiting any of either Party's obligations under the
Confidentiality Agreement, each Party shall not, and shall not permit any of its Subsidiaries or any Representative of such Party to, issue any press release or make any disclosure (to any customers
or employees of such Party, to the public or otherwise) regarding the Merger or any of the other Contemplated Transactions unless: (a) the other Party shall have approved such press release or
disclosure in writing; or (b) such Party shall have determined in good faith, upon the advice of outside legal counsel, that such disclosure is required by applicable Laws and, to the extent
practicable, before such press release or disclosure is issued or made, such Party advises the other Party of, and consults with the other Party regarding, the text of such press release or
disclosure;
provided
,
however
, that each of the Company and Saffron may make any public statement in
response to specific questions by the press, analysts, investors or those attending industry conferences or financial analyst conference calls, so long as any such statements are consistent with
previous press releases, public disclosures or public statements made by the Company or Saffron in compliance with this
Section 5.7
.
5.8 Listing
. At or prior to the Effective Time, Saffron shall use its commercially
reasonable efforts to cause the shares of Saffron Common Stock being issued in the
Merger to be approved for listing (subject to notice of issuance) on the NASDAQ Global Market (or such other NASDAQ market which the Saffron Common Stock then trades) at or prior to the Effective Time
and the Company shall use its commercially reasonable efforts to provide the information required for an initial listing
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application
pursuant to NASDAQ Rule 5110 and to fully cooperate and participate in preparing such application and obtaining such listing.
5.9 Tax Matters
.
(a) Saffron,
Merger Sub and the Company shall use their respective commercially reasonable efforts to cause the Merger, together with the issuance of shares of Saffron
Common Stock to the stockholders of the Company, to qualify, and agree not to, and not to permit or cause any affiliate or any subsidiary to, take any actions or cause any action to be taken that
would or could reasonably be expected to prevent or impede the Merger, together with the issuance of shares of Saffron Common Stock to the stockholders of the Company, from qualifying as a
"reorganization" under Section 368(a) of the Code.
(b) This
Agreement is intended to constitute, and the parties hereto hereby adopt this Agreement as, a "plan of reorganization" within the meaning Treasury Regulation
Sections 1.368-2(g) and 1.368-3(a). Saffron, Merger Sub and the Company shall treat, and shall not take any tax reporting position inconsistent with the treatment of, the Merger, together with
the issuance of shares of Saffron Common Stock to the stockholders of the Company, as a "reorganization" within the meaning of Section 368(a) of the Code for U.S. federal, state and other
relevant Tax purposes, unless otherwise required pursuant to a "determination" within the meaning of Section 1313(a) of the Code.
5.10 Cooperation
. Each Party shall cooperate reasonably with the other Party and
shall provide the other Party with such assistance as may be reasonably requested for the purpose of facilitating the performance by each Party of their obligations under this Agreement and to enable
the combined entity to continue to meet its obligations following the Closing.
5.11 Directors.
(a) Subject
to any legal requirement, at and immediately after the Effective Time, the initial size of the Board of Directors of Saffron shall be seven (7) and the
initial directors to serve on the Board of Directors of Saffron shall be Paul A. Friedman, M.D., who shall be the Chairman, and Fred Craves, Ph.D., who shall be the lead director, Rebecca Taub, M.D.,
Keith Gollust, two additional individuals to be selected by the Company, and one additional individual to be mutually agreed upon by Saffron and the Company, each until their respective successors are
duly elected or appointed and qualified or their earlier death, resignation or removal. At and immediately after the Effective Time, the officers of Saffron and the director classification shall be
specified in
Schedule 5.11
.
(b) Effective
immediately following the Effective Time, Saffron and the Surviving Corporation shall cause the size and composition of the board of directors of the Surviving
Corporation to be identical in size and composition to the board of directors of Saffron after taking into account the requirements and actions set forth in
Section 5.11(a)
, except that the board
of directors of the Surviving Corporation shall not be classified.
5.12 Stockholder Litigation
.
Until the earlier of the termination of this Agreement in accordance with its terms or the Effective Time, Saffron, on the one hand, and the Company, on the other hand, shall give the
other Party the opportunity to participate in the defense or settlement of any stockholder litigation relating to this Agreement or any of the Contemplated Transactions, and shall not settle any such
litigation without the other Party's written consent, which will not be unreasonably withheld, conditioned or delayed. Prior to or as promptly as practicable following the date hereof, Saffron and its
Board of Directors shall amend the Saffron Bylaws to include a provision requiring that the Court of Chancery of the State of Delaware shall be the exclusive forum for any disputes involving Saffron
stockholders' rights with respect to Saffron.
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5.13 Section 16 Matters
.
Prior to the Closing, the Board of Directors of Saffron shall use all reasonable efforts to approve in advance in accordance with the procedures set forth in Rule 16b-3
promulgated under the Exchange Act and the Skadden, Arps, Slate, Meagher & Flom LLP SEC No-Action Letter (January 12, 1999) any acquisitions and/or dispositions of equity
securities of Saffron resulting from the Contemplated Transactions by each Person who is subject to Section 16 of the Exchange Act (or who will become subject to Section 16 of the
Exchange Act as a result of the Contemplated Transactions) with respect to equity securities of Saffron.
5.14 Securityholder List
.
At least two (2) Business Days prior to the Effective Time, the Company shall deliver to Saffron a true, correct and complete list, as of that date, of all issued and outstanding
shares of the capital stock of the Company on a holder-by-holder basis.
5.15 Reverse Split
.
Saffron shall submit to the Saffron Stockholders at the Saffron Stockholder Meeting a proposal to approve and adopt an amendment to the Saffron Charter to authorize the Board of
Directors of Saffron to effect a reverse stock split of all outstanding shares of Saffron Common Stock at a reverse stock split ratio in the range mutually agreed to by the Company and Saffron (the
"
Reverse Stock Split
"), and shall take such other actions as shall be reasonably necessary to effectuate the Reverse Stock Split.
5.16 Preferred Stock and Convertible Debt
.
The Company shall take all action required to effect the conversion of all outstanding Company Preferred Stock and Convertible Debt into no more than the number of shares of Company
Common Stock set forth in
Section 5.16
of the Company Disclosure Schedule pursuant to the Company Stockholder Written Consent effective
immediately prior to the Effective Time, and the Company will provide Saffron with evidence of such conversion to the sole satisfaction of Saffron. The Company shall not prepay any Convertible Debt.
5.17 Validity of Private Placement for Merger Shares
.
In connection with the solicitation of the Company Stockholder Approval, the Company shall deliver to each holder of Company Capital Stock or any securities convertible into,
exchangeable for, or representing the right to subscribe for, purchase, or otherwise receive any shares of Company Capital Stock or any other equity security of the Company, a standard form of
accredited investor questionnaire. In reliance on such accredited investor questionnaires, Saffron and the Company shall take such action as reasonably necessary to ensure that the issuance of shares
of Saffron Common Stock in the Merger shall validly qualify for an exemption from the registration and prospectus delivery requirements of the Securities Act and the equivalent state "blue-sky" laws.
5.18 Forfeiture of Restricted Shares
.
The Company shall take all action required to ensure that the restricted shares of Company Common Stock set forth in
Section 5.18
of the Company Disclosure Schedule are forfeited to the Company and are no longer outstanding immediately prior to the Effective Time, and the Company will provide Saffron with evidence of such
conversion to the sole satisfaction of Saffron.
5.19 Company Final Financial Statements
.
The Company shall use reasonable best efforts to deliver to Saffron, (i) no later than April 15, 2016, true and complete copies of the Company's audited consolidated
balance sheet as of December 31, 2015 and December 31, 2014, and the related consolidated statements of operations, cash flows and stockholders equity for the twelve months ended
December 31, 2015 and December 31, 2014, together with the notes thereto and the reports and opinions of Friedman LLP relating thereto (the "
Company
Audited Financial Statements
"), and (ii) as soon as practicable but no later than April 29, 2016, true and complete copies of the Company's unaudited consolidated
balance sheet as of March 31, 2016 and the related unaudited consolidated statements of operations, cash flows and stockholders equity for the three months ended March 31, 2016, together
with the notes thereto (the "
Company Interim Financial Statements
", and together with the Company Audited Financial Statements, the
"
Company Final Financial Statements
"). The Company represents and warrants that (A) the Company Audited Financial Statements will not
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materially
differ from the Company Preliminary Financial Statements, and (B) the Company Final Financial Statements (i) will comply as to form in all material respects prior to the
filing of the Proxy Statement, with the published rules and regulations of the SEC with respect thereto, (ii) will be prepared in accordance with GAAP applied on a consistent basis (unless
otherwise noted therein) throughout the periods indicated and (iii) will fairly present, in all material respects, the financial condition and operating results of the Company as of the dates
and for the periods indicated therein.
Section 6. CONDITIONS PRECEDENT TO OBLIGATIONS OF EACH PARTY
The
obligations of each Party to effect the Merger and otherwise consummate the transactions to be consummated at the Closing are subject to the satisfaction or, to the extent permitted
by applicable Law, the written waiver by each of the Parties, at or prior to the Closing, of each of the following conditions:
6.1 No Restraints
.
No temporary restraining order, preliminary or permanent injunction or other order preventing the consummation of the Merger shall have been issued by any court of competent jurisdiction
or other Governmental Authority and remain in effect, and there shall not be any Law which has the effect of making the consummation of the Merger illegal.
6.2 Stockholder Approval
.
This Agreement, the Merger, the conversion of the Company Preferred Stock into Company Common Stock and the other Contemplated Transaction shall have been duly adopted and approved by
the Company Stockholder Approval, and the Saffron Stockholder Proposals shall have been duly approved by the Saffron Stockholder Approval.
6.3 No Governmental Proceedings Relating to Contemplated Transactions or Right to Operate Business
.
There shall not be any Legal Proceeding pending, or overtly threatened in writing, by an official of a Governmental Authority in which such Governmental Authority indicates that it
intends to conduct any Legal Proceeding or taking any other action: (a) challenging or seeking to restrain or prohibit the consummation of the Merger; (b) relating to the Merger and
seeking to obtain from Saffron, Merger Sub or the Company any damages or other relief that may be material to Saffron or the Company; or (c) seeking to prohibit or limit in any material and
adverse respect a Party's ability to vote, transfer, receive dividends with respect to or otherwise exercise ownership rights with respect to the stock of Saffron.
6.4 Proxy Statement
.
No stop order prohibiting the issuance of the Merger Shares shall have been issued and no proceedings for that purpose shall have been initiated or threatened by the SEC or any other
Governmental Authority and no similar proceeding in respect of the Proxy Statement shall have been initiated or threatened by the SEC or any Governmental Authority.
6.5 Blue Sky Laws
.
The actions set forth on Schedule 6.6 (relating to the state securities laws that must be complied with in connection with the Merger) will have been complied with and any
approval, consent, ratification, permission, waiver or authorization issued by any Governmental Authority related thereto will be in full force and effect.
Section 7. ADDITIONAL CONDITIONS PRECEDENT TO OBLIGATIONS OF SAFFRON AND MERGER SUB
The
obligations of Saffron and Merger Sub to effect the Merger and otherwise consummate the transactions to be consummated at the Closing are subject to the satisfaction or the written
waiver by Saffron, at or prior to the Closing, of each of the following conditions:
7.1 Accuracy of Representations
.
The representations and warranties of the Company contained in this Agreement (X) (a) shall have been true and correct as of the date of this Agreement, except for those
representations and warranties which address matters only as of a particular date (which representations shall have been true and correct as of such particular date) and (b) shall be true and
correct on and as of the Closing Date with the same force and effect as if made on the Closing Date,
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except
in each case where the failure to be true and correct has not had, and would not reasonably be expected to have, a Company Material Adverse Effect, and (Y) the representation and
warranties of the Company contained in
Section 2.2
hereof shall be true and correct as of the date hereof and as of the Closing Date, except
(a) to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct as of such date
and (b) for de minimis inaccuracies. For purposes of determining the accuracy of such representations and warranties, any update of or modification to the Company Disclosure Schedule made or
purported to have been made after the date of this Agreement shall be disregarded.
7.2 Performance of Covenants
.
Each of the covenants and obligations in this Agreement that the Company is required to comply with or to perform at or prior to the Closing shall have been complied with and performed
by the Company in all material respects.
7.3 Consents
.
(a) All
of the consents set forth on
Section 7.3(a)
of the Company Disclosure Schedule shall have been obtained and
shall be in full force and effect.
(b) Any
Permit or other consent required to be obtained by the Company under any applicable antitrust or competition Law or regulation or other Law shall have been obtained
and shall remain in full force and effect.
7.4 Officers' Certificate
.
Saffron shall have received a certificate executed by the Chief Executive Officer and Chief Financial Officer of the Company confirming that the conditions set forth in
Sections 7.1
,
7.2
, and
7.3
have been duly
satisfied.
7.5 No Company Material Adverse Effect
.
Since the date of this Agreement, there shall not have occurred any Company Material Adverse Effect.
7.6 Preferred Stock and Convertible Debt Conversion
.
The Company Preferred Stock and Convertible Debt shall cease to be outstanding and shall have been converted into no more than the number of shares of Company Common Stock set forth in
Section 5.16
of the Company Disclosure Schedule and the Company shall have provided Saffron with evidence of such conversion to the sole
satisfaction of Saffron.
7.7 Employment Agreements
.
Employment agreements shall have been executed with Paul A. Friedman, M.D. and Rebecca Taub, M.D., to the sole satisfaction of Saffron.
7.8 Company Private Placement
.
The Company Private Placement shall have been consummated and the Company shall have received an aggregate of $9,000,000 of gross proceeds, including a tranche of $750,000 of gross
proceeds received by the Company on March 1, 2016 and a tranche of $2,625,000 of gross proceeds to be received by the Company concurrently with or prior to the signing of this Agreement, on the
terms and conditions thereof.
7.9 Restricted Shares
.
The restricted shares of Company Common Stock set forth in
Section 5.18
of the Company Disclosure Schedule shall have been
forfeited to the Company and shall no longer be outstanding, and the Company shall have provided evidence of such forfeiture to the sole satisfaction of Saffron.
7.10 Company Indebtedness
.
All Indebtedness of the Company, including without limitation the Indebtedness set forth in
Section 7.10
of the Company Disclosure
Schedule, shall have been repaid, settled or extinguished, and the Company shall have provided evidence of the repayment, settlement or extinguishment of such Indebtedness to the sole satisfaction of
Saffron.
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Section 8. ADDITIONAL CONDITIONS PRECEDENT TO OBLIGATION OF THE COMPANY
The
obligations of the Company to effect the Merger and otherwise consummate the transactions to be consummated at the Closing are subject to the satisfaction or the written waiver by
the Company, at or prior to the Closing, of each of the following conditions:
8.1 Accuracy of Representations
.
The representations and warranties of Saffron and Merger Sub contained in this Agreement (a) shall have been true and correct as of the date of this Agreement except for those
representations and warranties which address matters only as of a particular date (which representations shall have been true and correct as of such particular date) and (b) shall be true and
correct on and as of the Closing Date with the same force and effect as if made on the Closing Date, except in each case where the failure to be true and correct has not had, and would not reasonably
be expected to have, a Saffron Material Adverse Effect, it being understood that, for purposes of determining the accuracy of such representations and warranties, any update of or modification to the
Saffron Disclosure Schedule made or purported to have been made after the date of this Agreement shall be disregarded.
8.2 Performance of Covenants
.
All of the covenants and obligations in this Agreement that Saffron or Merger Sub is required to comply with or to perform at or prior to the Closing shall have been complied with and
performed in all material respects.
8.3 Consents
.
(a) All
the consents set forth on
Section 8.3
of the Saffron Disclosure Schedule shall have been obtained and shall be
in full force and effect.
(b) Any
Permit or other consent required to be obtained by Saffron under any applicable antitrust or competition Law or regulation or other Law shall have been obtained and
shall remain in full force and effect.
8.4 Officers' Certificates
.
The Company shall have received (a) a certificate executed by the Chief Executive Officer of Saffron confirming that the conditions set forth in
Sections 8.1
,
8.2
and
8.3
have been duly
satisfied and (b) three (3) days prior to the Closing, a certificate executed by the Chief Financial Officer of Saffron certifying that the contents of the Net Cash Schedule, as well as
the work papers and back-up materials provided therewith, are true and correct in all material respects and that the Net Cash Condition has been satisfied.
8.5 No Saffron Material Adverse Effect
.
Since the date of this Agreement, there shall not have occurred any Saffron Material Adverse Effect.
8.6 Minimum Net Cash
.
The Net Cash of Saffron at the Closing shall not be less than $28,500,000 (the "
Net Cash Condition
").
Section 9. TERMINATION
9.1 Termination
. This Agreement may be terminated prior to the Effective Time
(whether before or after adoption of this Agreement by the Company's stockholders and whether before or after approval of the Merger and issuance of Saffron Common Stock in the Merger by Saffron's
stockholders, unless otherwise specified below):
(a) by
mutual written consent of Saffron and the Company duly authorized by the Boards of Directors of Saffron and the Company;
(b) by
either Saffron or the Company if the Merger shall not have been consummated by September 30, 2016;
provided
,
however
, that the right to terminate this
Agreement under this
Section 9.1(b)
shall not be
available to any Party whose action or failure to act has been a principal
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cause
of the failure of the Merger to occur on or before such date and such action or failure to act constitutes a breach of this Agreement;
(c) by
either Saffron or the Company if a court of competent jurisdiction or other Governmental Authority shall have issued a final and nonappealable order, decree or
ruling, or shall have taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the Merger;
(d) by
Saffron if the Company Stockholder Approval shall not have been obtained within twenty-four (24) hours after this Agreement is executed by the Parties;
(e) by
either Saffron or the Company if (i) the Saffron Stockholder Meeting (including any adjournments and postponements thereof) shall have been held and completed
and Saffron's stockholders shall have taken a final vote on the Merger, the Contemplated Transactions and the issuance of shares of Saffron Common Stock in the Merger and (ii) the Merger, such
transactions or any of the issuance of Saffron Common Stock in the Merger and Reverse Stock Split shall not have been approved at the Saffron Stockholder Meeting (and shall not have been approved at
any adjournment or postponement thereof) by the Saffron Stockholder Approval;
provided
,
however
, that
the right to terminate this Agreement under this
Section 9.1(e)
shall not be available to Saffron where the failure to obtain the Saffron
Stockholder Approval shall have been caused by the action or failure to act of Saffron and such action or failure to act constitutes a material breach by Saffron of this Agreement;
(f) by
the Company (at any time prior to the approval of the issuance of Saffron Common Stock in the Merger by the Saffron Stockholder Approval) if a Saffron Change of
Recommendation shall have occurred or Saffron fails to include the Saffron Recommendation in the Proxy Statement;
(g) by
the Company, upon a breach of any representation, warranty, covenant or agreement on the part of Saffron or Merger Sub set forth in this Agreement, or if any
representation or warranty of Saffron or Merger Sub shall have become inaccurate, in either case such that the conditions set forth in
Section 8.1
or
Section 8.2
would not be satisfied as of the time of such breach or as of
the time such representation or warranty shall have become inaccurate,
provided
that if such inaccuracy in Saffron's or Merger Sub's representations and
warranties or breach by Saffron or Merger Sub is curable by Saffron or Merger Sub, then this Agreement shall not terminate pursuant to this
Section 9.1(g)
as a result of such particular breach or
inaccuracy until the earlier of (i) the expiration of a 30 day period
commencing upon delivery of written notice from Saffron or Merger Sub to the Company of such breach or inaccuracy and (ii) Saffron or Merger Sub (as applicable) ceasing to exercise commercially
reasonable efforts to cure such breach (it being understood that this Agreement shall not terminate pursuant to this
Section 9.1(g)
as a result
of such particular breach or inaccuracy if such breach by Saffron or Merger Sub is cured prior to such termination becoming effective);
(h) by
Saffron, upon a breach of any representation, warranty, covenant or agreement on the part of the Company set forth in this Agreement, or if any representation or
warranty of the Company shall have become inaccurate, in either case such that the conditions set forth in
Section 7.1
or
Section 7.2
would not
be satisfied as of the time of such breach or as of the time such representation or warranty shall have become inaccurate,
provided
that if such inaccuracy in the Company's representations and
warranties or breach by the Company is curable by the Company then this Agreement
shall not terminate pursuant to this
Section 9.1(h)
as a result of such particular breach or inaccuracy until the earlier of (i) the
expiration of a 30 day period commencing upon delivery of written notice from the Company to Saffron of such breach or inaccuracy and (ii) the Company ceasing to exercise commercially
reasonable efforts to cure such breach (it being understood that this Agreement shall not terminate pursuant to this
Section 9.1(h)
as a result
of such particular breach or inaccuracy if such breach by the Company is cured prior to such termination becoming effective);
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(i) by
Saffron in connection with Saffron entering into a definitive agreement to effect a Saffron Superior Offer; or
(j) by
the Company if, at any time after the date hereof and prior to the Closing, Saffron's Net Cash has fallen below $28,500,000 such that the Net Cash Condition would not
be satisfied as of such time, and such deficiency is not likely to be cured prior to the Closing Date.
9.2 Effect of Termination
.
In the event of the termination of this Agreement as provided in
Section 9.1
, this Agreement shall be of no further force or
effect;
provided
,
however
, that (i) this
Section 9.2
,
Section 9.3
, and
Section 10
shall survive the termination of this Agreement and shall remain in full force and effect, and (ii) the termination of this
Agreement shall not relieve any Party from any liability for any material breach of any representation, warranty, covenant, obligation or other provision contained in this Agreement.
9.3 Expenses; Termination Fees
.
(a) Except
as set forth in this
Section 9.3
, all fees and expenses incurred in connection with this Agreement and the
Contemplated Transactions shall be paid by the Party incurring such expenses, whether or not the Merger is consummated.
(b) If
this Agreement is terminated by Saffron or the Company, as applicable, pursuant to
Section 9.1(e)
or
Section 9.1(j)
, Saffron shall pay to the
Company within two (2) Business Days after termination of the Agreement an amount equal to the
total documented expenses incurred by the Company or the Company's stockholders in connection with the negotiation and execution of this Agreement and the Contemplated Transactions, not to exceed
$250,000 in the aggregate.
(c) (i) If
this Agreement is terminated by Saffron or the Company pursuant to
Section 9.1(f)
or
9.1(i)
, Saffron shall pay to the Company, within ten
(10) Business Days after termination of the Agreement, a nonrefundable fee in an amount
equal to $1,250,000.
(ii) If
this Agreement is terminated by Saffron pursuant to
Section 9.1(d)
, the Company shall pay to Saffron, within
ten (10) Business Days after termination of the Agreement, a nonrefundable fee in an amount equal to $1,000,000.
(d) If
either Party fails to pay when due any amount payable by such Party under
Section 9.3(a)
,
9.3(b)
, or 9.3(c) then (i) such Party shall reimburse
the other Party for reasonable costs and expenses (including reasonable fees and
disbursements of counsel) incurred in connection with the collection of such overdue amount and the enforcement by the other Party of its rights under this
Section 9.3
, and (ii) such Party
shall pay to the other Party interest on such overdue amount (for the period commencing as of the date
such overdue amount was originally required to be paid and ending on the date such overdue amount is actually paid to the other Party in full) at a rate per annum equal to the "prime rate" (as
announced by Bank of America or any successor thereto) in effect on the date such overdue amount was originally required to be paid.
Section 10. MISCELLANEOUS PROVISIONS
10.1 Non-Survival of Representations and Warranties
.
The representations and warranties of the Company, Merger Sub and Saffron contained in this Agreement or any certificate or instrument delivered pursuant to this Agreement shall
terminate at the Effective Time, and only the covenants that by their terms survive the Effective Time and this
Section 10
shall survive the
Effective Time.
10.2 Amendment
. This Agreement may be amended with the approval of the respective
Boards of Directors of the Company and Saffron at any time (whether before or after the adoption and approval of this Agreement by the Company's stockholders or before or after the approval of the
Merger or issuance of shares of Saffron Common Stock in the Merger);
provided
,
however
, that after any
such adoption and approval of this Agreement by a Party's stockholders, no amendment shall be
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made
which by Law requires further approval of the stockholders of such Party without the further approval of such stockholders. This Agreement may not be amended except by an instrument in writing
signed on behalf of each of the Company and Saffron.
10.3 Waiver
.
(a) No
failure on the part of any Party to exercise any power, right, privilege or remedy under this Agreement, and no delay on the part of any Party in exercising any
power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or
remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy.
(b) No
Party shall be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such
claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of such Party; and any such waiver shall not be applicable or have any
effect except in the specific instance in which it is given.
10.4 Entire Agreement; Counterparts; Exchanges by Facsimile
.
This Agreement and the other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among
or between any of the Parties with respect to the subject matter hereof and thereof;
provided
,
however
,
that the Confidentiality Agreement shall not be superseded and shall remain in full force and effect in accordance with its terms. This Agreement may be executed in several counterparts, each of which
shall be deemed an original and all of which shall constitute one and the same instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all Parties by facsimile or
electronic transmission via ".pdf" shall be sufficient to bind the Parties to the terms and conditions of this Agreement.
10.5 Applicable Law; Jurisdiction
.
This Agreement shall be governed by, and construed in accordance with, the Laws of the State of Delaware, regardless of the Laws that might otherwise govern under applicable principles
of conflicts of Laws. In any action or proceeding between any of the parties arising out of or relating to this Agreement or any of the Contemplated Transactions, each of the parties:
(i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Court of Chancery of the State of Delaware or to the extent such court does not have
subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, (ii) agrees that all claims in respect of such action
or proceeding shall be heard and determined exclusively in accordance with clause (i) of this
Section 10.5
, (iii) waives any
objection to laying venue in any such action or proceeding in such courts, (iv) waives any objection that such courts are an inconvenient forum or do not have jurisdiction over any party, and
(v) agrees that service of process upon such party in any such action or proceeding shall be effective if notice is given in accordance with
Section 10.8
of this Agreement.
10.6 Attorneys' Fees
.
In any action at Law or suit in equity to enforce this Agreement or the rights of any of the parties under this Agreement, the prevailing Party in such action or suit shall be entitled
to receive a reasonable sum for its attorneys' fees and all other reasonable costs and expenses incurred in such action or suit.
10.7 Assignability
. This Agreement shall be binding upon, and shall be enforceable
by and inure solely to the benefit of, the parties hereto and their respective successors and assigns;
provided
,
however
, that neither this Agreement nor
any of a Party's rights or obligations hereunder may be assigned or delegated by such Party without the prior
written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by such Party without the other Party's prior written consent
shall be void and of no effect. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person (other than: (a) the parties hereto;
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and
(b) the directors and officers of the Company referred to in
Section 5.5(a)
to the extent of their respective rights pursuant to
Section 5.5
) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
10.8 Notices
. Any notice or other communication required or permitted to be
delivered to any Party under this Agreement shall be in writing and shall be deemed properly delivered, given and received when delivered by hand, by registered mail, by courier or express delivery
service or by facsimile to the address or facsimile telephone number set forth beneath the
name of such Party below (or to such other address or facsimile telephone number as such Party shall have specified in a written notice given to the other parties hereto):
if
to Saffron or Merger Sub:
Synta
Pharmaceuticals Corp.
45 Hartwell Avenue
Lexington, MA 02421
Telephone: (781) 274-8200
Fax: (781) 274-8228
Attention: Chief Executive Officer
with
a copy to:
Mintz,
Levin, Cohn, Ferris, Glovsky & Popeo, P.C.
One Financial Center
Boston, Massachusetts 02111
Fax: (617) 542-2241
Attention: Matthew J. Gardella, Esq.
if
to the Company:
Madrigal
Pharmaceuticals, Inc.
500 Office Center Drive, Suite 400
Fort Washington, PA 19034
Telephone: (267) 327-4424
Fax: (949) 725-4100
Attention: Chief Executive Officer
with
a copy to:
Stradling
Yocca Carlson & Rauth, P.C.
660 Newport Center Drive, Suite 1600
Newport Beach, CA 92660
Telephone: (949) 725-4000
Fax: (949) 725-4100
Attention: Lawrence B. Cohn, Esq.
Michael L. Lawhead, Esq.
10.9 Cooperation
. Each Party agrees to cooperate fully with the other Party and to
execute and deliver such further documents, certificates, agreements and instruments and to take such other actions as may be reasonably requested by the other Party to evidence or reflect the
Contemplated Transactions and to carry out the intent and purposes of this Agreement.
10.10 Severability
. Any term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the
offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction
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declares
that any term or provision of this Agreement is invalid or unenforceable, the Parties hereto agree that the court making such determination shall have the power to limit such term or
provision, to delete specific words or phrases or to replace such term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this Agreement shall be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence,
the Parties hereto agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and
other purposes of such invalid or unenforceable term or provision.
10.11 Other Remedies; Specific Performance
.
Except as otherwise provided herein, any and all remedies herein expressly conferred upon a Party will be deemed cumulative with and not exclusive of any other remedy conferred hereby,
or by Law or equity upon such Party, and the exercise by a Party of any one remedy will not preclude the exercise of any other remedy. The Parties hereto agree that irreparable damage would occur in
the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the Parties shall be
entitled to seek an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having
jurisdiction, this being the addition to any other remedy to which they are entitled at Law or in equity.
10.12 Construction
.
(a) For
purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the
feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.
(b) The
Parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting Party shall not be applied in the
construction or interpretation of this Agreement.
(c) As
used in this Agreement, the words "include" and "including," and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be
followed by the words "without limitation."
(d) Except
as otherwise indicated, all references in this Agreement to "Sections," "Exhibits" and "Schedules" are intended to refer to Sections of this Agreement and
Exhibits and Schedules to this Agreement, respectively.
(e) The
bold-faced headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred
to in connection with the construction or interpretation of this Agreement.
[Remainder of page intentionally left blank]
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IN WITNESS WHEREOF
, the parties have caused this Agreement to be executed as of the date first above written.
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SYNTA PHARMACEUTICALS CORP.
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By:
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/s/ CHEN SCHOR
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Name:
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Chen Schor
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Title:
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President and Chief Executive Officer
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SAFFRON MERGER SUB, INC.
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By:
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/s/ CHEN SCHOR
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Name:
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Chen Schor
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Title:
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President
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MADRIGAL PHARMACEUTICALS, INC.
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By:
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/s/ REBECCA TAUB
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Name:
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Rebecca Taub, M.D.
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Title:
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Acting Chief Executive Officer
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[Signature Page to Agreement and Plan of Merger and Reorganization]
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EXHIBIT A
Definitions
"
Affiliate
" means with respect to any Person, any other Person controlling, controlled
by, or under common control with such Person. As used in this definition, "control" (including, with its correlative meanings, "controlled by" and "under common control with") means the possession,
directly or indirectly, of power to direct or cause the direction of the management and policies of a Person whether through the ownership of voting securities, by contract or otherwise.
"
Agreement
" has the meaning set forth in the Preamble and shall include the Exhibits and Schedules annexed hereto or referred to herein.
"
Business Day
" means any day other than (a) a Saturday or Sunday, or (b) a day on which banking and savings and loan
institutions are authorized or required by Laws to be closed in the Commonwealth of Massachusetts.
"
Certificate of Merger
" has the meaning set forth in
Section 1.3
"
Closing
" has the meaning set forth in
Section 1.3
.
"
Closing Date
" has the meaning set forth in
Section 1.3
.
"
Code
" means the Internal Revenue Code of 1986, as amended.
"
Company
" has the meaning set forth in the Preamble.
"
Company Acceptable Confidentiality Agreement
" has the meaning set forth in
Section 4.5(a)
.
"
Company Acquisition Proposal
" has the meaning set forth in
Section 4.5(a)(ii)(A)
.
"
Company Ancillary Lease Documents
" means all subleases, overleases and other ancillary agreements or documents pertaining to the tenancy
at each such parcel of the Company Leased Real Property that materially affect or may materially affect the tenancy at any Company Leased Real Property.
"
Company Balance Sheet
" has the meaning set forth in
Section 2.5(a)
.
"
Company Board Recommendation
" has the meaning set forth in
Section 5.2(a)(ii)
.
"
Company Business
" means the business of the Company as currently conducted.
"
Company Bylaws
" has the meaning set forth in
Section 2.1(a)
.
"
Company Capital Stock
" means the Common Stock and Preferred Stock of the Company.
"
Company Change of Recommendation
" has the meaning set forth in
Section 4.5(a)
.
"
Company Charter
" has the meaning set forth in
Section 2.1(a)
.
"
Company Common Stock
" means the common stock, $0.0001 par value per share, of the Company.
"
Company Contingent Workers
" has the meaning set forth in
Section 2.15(b)
.
"
Company Contract
" means any Contract together with any amendments, waivers or other modifications thereto, to which the Company is a
party.
"
Company Copyrights
" has the meaning set forth in
Section 2.9(a)
.
"
Company Disclosure Schedule
" has the meaning set forth in
Section 2
.
"
Company Employee Program
" has the meaning set forth in
Section 2.14(a)
.
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Table of Contents
"
Company Audited Financial Statements
" has the meaning set forth in
Section 5.19
.
"
Company Final Financial Statements
" has the meaning set forth in
Section 5.19
.
"
Company Interim Financial Statements
" has the meaning set forth in
Section 5.19
.
"
Company Preliminary Financial Statements
" has the meaning set forth in
Section 2.5(a)
.
"
Company Intellectual Property
" means all Intellectual Property owned by the Company or used or held for use by the Company in the Company
Business and all Company Products. "Company Intellectual Property" includes, without limitation, Company Products, Company Patents, Company Marks, Company Copyrights and Company Trade Secrets.
"
Company Lease
" means the lease, license, sublease or other occupancy agreements and all amendments, modifications, supplements, and
assignments thereto, together with all exhibits, addenda, riders and other documents constituting a part thereof for each parcel of the Company Leased Real Property.
"
Company Leased Real Property
" means the real property leased, subleased or licensed by the Company that is related to or used in
connection with the Company Business, and the real property leased, subleased or licensed by the Company as tenant, subtenant, licensee or other similar party, together with, to the extent leased,
licensed or owned by the Company, all buildings and other structures, facilities or leasehold improvements, currently or hereafter located thereon.
"
Company Licenses-In
" has the meaning set forth in
Section 2.9(a)
.
"
Company Licenses-Out
" has the meaning set forth in
Section 2.9(a)
.
"
Company Marks
" has the meaning set forth in
Section 2.9(a)
.
"
Company Material Adverse Effect
" means any change, circumstance, condition, development, effect, event, occurrence, result or state of
facts that, individually or when taken together with any other such change, circumstance, condition, development, effect, event, occurrence, result or state of facts, has or would reasonably be
expected to (a) have a material adverse effect on the business, financial condition, assets, liabilities or results of operations of the Company, except that none of the following shall be
taken into account in determining whether there has been a Company Material Adverse Effect: (i) changes in general economic or political conditions or the securities market in general (whether
as a result of acts of terrorism, war (whether or not declared), armed conflicts or otherwise) to the extent they do not disproportionately affect the Company; (ii) changes in or affecting the
industries in which the Company operates to the extent they do not disproportionately affect the Company in any material respect; (iii) changes, effects or circumstances resulting from the
announcement or pendency of this Agreement or the consummation of the Contemplated Transactions or compliance with the terms of this Agreement; (iv) any specific action taken at the written
request of Saffron or Merger Sub or expressly required by this Agreement; and (v) continued losses from operations or decreases in cash
balances of the Company; or (b) prevent or materially delay the ability of Company to consummate the Contemplated Transactions.
"
Company Material Contract
" has the meaning set forth in
Section 2.10.
"
Company Minimum Holders
" means the holders of at least a majority of the outstanding shares of Company Capital Stock voting together as a
single class and on an as-converted basis.
"
Company Owned Real Property
" means the real property in which the Company has any fee title (or equivalent).
"
Company Patents
" has the meaning set forth in
Section 2.9(a)
.
"
Company Permits
" has the meaning set forth in
Section 2.12(b)
.
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Table of Contents
"
Company Preferred Stock
" means the preferred stock, $0.0001 par value per share, of the Company.
"
Company Private Placement
" has the meaning set forth in the Recitals.
"
Company Products
" means MGL-3196, MGL-3745 and the other products described in (i) the Company Patents, (ii) that certain
Research, Development and Commercialization Agreement, dated December 18, 2008, by and between Hoffman-La Roche, Inc. and F. Hoffman-La Roche Ltd, on the one hand, and the VIA
Pharmaceuticals, Inc., on the other hand (pertaining to R04923659-000) and (iii) that certain Research, Development and Commercialization Agreement, dated December 18, 2008, by
and between Hoffman-La Roche, Inc. and F. Hoffman-La Roche Ltd, on the one hand, and the VIA Pharmaceuticals, Inc., on the other hand (pertaining to R05131723).
"
Company Qualified Bidder
" has the meaning set forth in
Section 4.5(a)(i)
.
"
Company Regulatory Agency
" has the meaning set forth in
Section 2.12(b)
.
"
Company Stock Certificate
" has the meaning set forth in
Section 1.6
.
"
Company Stockholder Approval
" has the meaning set forth in
Section 2.24
.
"
Company Stockholder Written Consent
" means (a) the irrevocable adoption of this Agreement and approval of the Merger and
(b) specified undertakings, representations, warranties, releases and waivers, pursuant to a written consent in substantially the form attached hereto as
Exhibit F
and otherwise reasonably
acceptable to Saffron, signed by the Company Minimum Stockholders, pursuant to and in accordance with the
applicable provisions of the DGCL and the Company Charter..
"
Company Stockholders
" shall mean the holders of the capital stock of the Company immediately prior to the Effective Time.
"
Company Superior Offer
" has the meaning set forth in
Section 4.5(a)(ii)(B)
.
"
Company Trade Secrets
" has the meaning set forth in
Section 2.9(k)
.
"
Company Voting Agreements
" has the meaning set forth in the Recitals.
"
Confidentiality Agreement
" means that certain confidential disclosure agreement, dated as of October 23, 2015, by and between the
Company and Saffron.
"
Contemplated Transactions
" means the transactions proposed under this Agreement, including the Merger and Reverse Stock Split.
"
Contract
" means any loan or credit agreement, bond, debenture, note, mortgage, indenture, lease, supply agreement, license agreement,
development agreement or other contract, agreement, arrangement, understanding, obligation, commitment or instrument that is legally binding, whether written or oral.
"
Convertible Debt
" means outstanding convertible promissory notes issued by the Company to certain lenders pursuant to the Company Private
Placement, that certain Note Purchase Agreement, dated as of September 16, 2011, as amended, and that certain Assignment and Issuance Agreement, dated as of September 14, 2011.
"
DGCL
" means the Delaware General Corporation Law.
"
Dissenting Shares
" has the meaning set forth in
Section 1.8(a)
.
"
Effective Time
" has the meaning set forth in
Section 1.3
.
"
Employee Program
" means (A) all employee benefit plans within the meaning of ERISA Section 3(3), including, but not limited
to, multiple employer welfare arrangements (within the meaning
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of
ERISA Section 3(40)), plans to which more than one unaffiliated employer contributes and employee benefit plans (such as foreign or excess benefit plans) which are not subject to ERISA; and
(B) all equity compensation, retention, bonus, incentive, severance, deferred compensation, supplemental income, vacation, profit sharing, executive compensation, change in control, material
fringe benefit, vacation, retiree benefit, health or other medical, dental, life, disability or other insurance plan, program, agreement or arrangement and all other written employee benefit plans,
agreements, and arrangements not described in (A) above, including without limitation, any arrangement intended to comply with Code Section 120, 125, 127, 129 or 137. In the case of an
Employee Program funded through a trust described in Code Section 401(a) or an organization described in Code Section 501(c)(9), or any other funding vehicle, each reference to such
Employee Program shall include a reference to such trust, organization or other vehicle.
"
Encumbrance
" means any mortgage, deed of trust, pledge, security interest, attachment, hypothecation, lien (statutory or otherwise),
violation, charge, lease, license, option, right of first offer, right of first refusal, encumbrance, servient easement, deed restriction, adverse claim, reversion, reverter, preferential arrangement,
restrictive covenant, condition or restriction of any kind or charge of any kind (including, without limitation, any conditional sale or title retention agreement or lease in the nature thereof) or
any agreement to file any of the foregoing, any sale of receivables with recourse against either the Company or Saffron, as the case may be, or any subsidiary, stockholder or Affiliate thereof, and
any filing or agreement to file any financing statement as debtor under the Uniform Commercial Code or any similar statute.
"
Environment
" means soil, surface waters, groundwater, land, stream sediments, surface or subsurface strata and ambient air and biota
living in or on such media.
"
Environmental Laws
" means Laws relating to protection of the Environment or the protection of human health as it relates to the
Environment, including, without limitation, the federal Comprehensive Environmental Response, Compensation and Liability Act, the Resource Conservation and Recovery Act, the Clean Air Act, the Clean
Water Act, the Toxic Substances Control Act, the Endangered Species Act and similar foreign, federal, state and local Laws as in effect on the Closing Date.
"
ERISA
" means the Employee Retirement Income Security Act of 1974, as amended.
"
ERISA Affiliate
" has the meaning ascribed thereto in
Sections 2.14(h)(ii)
and
3.14(h)(ii)
hereof, as applicable.
"
Exchange Act
" means the Securities Exchange Act of 1934, as amended.
"
Exchange Ratio
" shall be equal to 5.5740.
"
FDA
" has the meaning set forth in
Section 2.12(b)
.
"
FDCA
" has the meaning set forth in
Section 2.12(b)
.
"
Fractional Share Cash Amount
" has the meaning set forth in
Section 1.5(c)
.
"
GAAP
" means generally accepted accounting principles and practices in effect from time to time within the United States applied
consistently throughout the period involved.
"
Governmental Authority
" means any U.S. or foreign, federal, state, or local governmental commission, board, body, bureau, or other
regulatory authority, agency, including courts and other judicial bodies, or any self-regulatory body or authority, including any instrumentality or entity designed to act for or on behalf of the
foregoing.
"
Hazardous Material
" means any pollutant, toxic substance, hazardous waste, hazardous materials, hazardous substances, petroleum or
petroleum-containing products as defined in, or listed under, any Environmental Law.
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"
Health Care Law
" has the meaning set forth in
Section 2.12(c)
.
"
HSP Assets
" means any and all assets relating to Saffron's development of oncology medicines, including, but not limited to, any and all
assets relating to the ganetespib, STA-12-8666 and HSP90 compounds.
"
Indebtedness
" means Liabilities (a) for borrowed money, (b) evidenced by bonds, debentures, notes or similar instruments,
(c) upon which interest charges are customarily paid (other than obligations accepted in connection with the purchase of products or services in the ordinary course of business), (d) of
others secured by (or which the holder of such Liabilities has an existing right, contingent or otherwise, to be secured by) any Encumbrance or security interest on property owned or acquired by the
Person in question whether or not the obligations secured thereby have been assumed, (e) under leases required to be accounted for as capital leases under GAAP, or (f) guarantees
relating to any such Liabilities.
"
Intellectual Property
" means any and all of the following, as they exist throughout the world: (A) patents, patent applications of
any kind, patent rights, inventions, discoveries and invention disclosures (whether or not patented) (collectively, "
Patents
"); (B) rights in
registered and unregistered trademarks, service marks, trade names, trade dress, logos, packaging design, slogans and Internet domain names, and registrations and applications for registration of any
of the foregoing (collectively, "
Marks
"); (C) copyrights in both published and unpublished works, including without limitation all compilations,
databases and computer programs, manuals and other documentation and all copyright registrations and applications, and all derivatives, translations, adaptations and combinations of the above
(collectively, "
Copyrights
"); (D) rights in know-how, trade secrets, confidential or proprietary information, research in progress, algorithms,
data, designs, processes, formulae, drawings, schematics, blueprints, flow charts, models, strategies, prototypes, techniques, Beta testing procedures and Beta testing results (collectively,
"
Trade Secrets
"); (E) any and all other intellectual property rights and/or proprietary rights relating to any of the foregoing; and
(F) goodwill, franchises, licenses, permits, consents, approvals, and claims of infringement and misappropriation against third parties.
"
Intervening Event
" means any event, change, effect, development, condition or occurrence that (a) does not relate to any Saffron
Acquisition Proposal and (b) is not known and was not reasonably foreseeable to the Board of Directors of Saffron as of the date hereof.
"
IRS
" means the Internal Revenue Service of the United States.
"
Knowledge of Saffron
" means the actual knowledge of the chief executive officer and chief financial officer of Saffron, after due inquiry
by each such individual of each such individual's direct reports.
"
Knowledge of the Company
" means the actual knowledge of Fred Craves, Ph.D. and Rebecca Taub, M.D. after due inquiry by each such
individual of each such individual's direct reports.
"
Law
" or "
Laws
" means any federal, state, local, municipal, foreign (including foreign
political subdivisions) or other law, Order, statute, constitution, principle of common law or equity, resolution, ordinance, code, writ, edict, decree, consent, approval, concession, franchise,
permit, rule, regulation, judicial or administrative ruling, franchise, license, judgment, injunction, treaty, convention or other governmental certification, authorization or requirement issued,
enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Authority, and the term "applicable" with respect to such Laws and in the context
that refers to one or more Persons means that such Laws apply to such Person or Persons or its or their business, undertaking, property or security and put into effect by or under the authority of a
Governmental Authority having jurisdiction over the Person or Persons or its or their business, undertaking, property or security.
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"
Legal Proceeding
" means any action, arbitration, cause of action, claim, complaint, criminal prosecution, demand letter, governmental or
other examination or investigation, hearing, inquiry, administrative or other proceeding, or notice by any Person alleging potential liability.
"
Liability
" has the meaning set forth in
Section 2.11
.
"
Merger
" has the meaning set forth in the Recitals.
"
Merger Shares
" has the meaning set forth in
Section 1.5
.
"
Merger Sub
" has the meaning set forth in the Preamble.
"
Multiemployer Plan
" means an employee pension benefit plan or welfare benefit plan described in Section 4001(a)(3) of ERISA.
"
Net Cash
" means, as of any particular time, (x) Saffron's cash and cash equivalents, short-term investments, net and restricted
cash,
plus
(y) accounts receivable,
minus
(z) the aggregate of the following obligations
and liabilities of Saffron, calculated without duplication:
(i) All
accounts payable and severance payments;
(ii) All
Indebtedness of Saffron for borrowed money or in respect of capitalized leases or the purchase of assets of Saffron (including all principal, accrued interest
thereon (and if such Indebtedness is not prepayable, all remaining interest to be paid or accrued through maturity thereof)), and any other amounts payable to the holders of such Indebtedness as a
result of or in connection with, the consummation of the Contemplated Transactions);
(iii) All
out-of-pocket closing or transactional costs in connection with the Contemplated Transactions (excluding any stockholder litigation relating to this Agreement or
any of the Contemplated Transactions and excluding the Fractional Share Cash Amount), including amounts payable to financial advisors (including investment banks), attorneys, accountants or proxy
solicitors that are paid, incurred or expected to be incurred, payable or subject to reimbursement by Saffron; and
(iv) Only
those accrued expenses not already contemplated by clauses (i), (ii) and (iii) above, resulting from any incurred but yet unbilled
professional fees, clinical costs, preclinical costs or operational costs pertaining to goods or services previously provided to Saffron as of the month end date prior to the Closing.
"
Net Cash Condition
" has the meaning set forth in
Section 8.6
.
"
Net Cash Schedule
" has the meaning set forth in
Section 5.4
.
"
Notice Period
" has the meaning set forth in
Section 4.5(b)(iv)
.
"
Official
" has the meaning set forth in
Section 2.22
.
"
Ordinary Course of Business
" means with respect to a Party, the ordinary and usual course of normal day-to-day operations of such Party,
except that with respect to Saffron and its Subsidiaries, "Ordinary Course of Business" means the ordinary and usual course of normal day-to-day operations of Saffron and its Subsidiaries from and
after March 1, 2016 and/or consistent with the operating plans delivered to the Company.
"
Order
" means any judgment, order, writ, injunction, ruling, decision or decree of, or any settlement under the jurisdiction of, any Court
or Governmental Authority.
"
Party
" or "
Parties
" means Saffron, Merger Sub and the Company.
"
Permit
" means any franchise, authorization, approval, Order, consent, license, certificate, permit, registration, qualification or other
right or privilege.
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"
Permitted Encumbrances
" means (i) Encumbrances for Taxes or other governmental charges, assessments or levies that are not yet due
and payable or being contested in good faith by appropriate proceedings, (ii) statutory landlord's, mechanic's, carrier's, workmen's, repairmen's or other similar Encumbrances arising or
incurred in the ordinary course of business, the existence of which does not, and would not reasonably be expected to, materially impair the marketability, value or use and enjoyment of the asset
subject to such Encumbrances, and (iii) Encumbrances and other conditions, easements and reservations of rights, including rights of way, for sewers, electric lines, telegraph and telephone
lines and other similar purposes, and affecting the fee title to any real property leased by the Company and being transferred to Saffron or Merger Sub at Closing which are of record as of the date of
this Agreement and the existence of which does not, and would not reasonably be expected to, materially impair use and enjoyment of such real property, and (iv) with respect to Leased Real
Property only, Encumbrances (including Indebtedness) encumbering the fee title interested in any Leased Real Property which are not attributable to the Company. Notwithstanding the foregoing, any
Encumbrances for Indebtedness of the Company as of the Closing will not be a Permitted Encumbrance.
"
Person
" means any individual, corporation, firm, partnership, joint venture, association, trust, company, Governmental Authority,
syndicate, body corporate, unincorporated organization, or other legal entity, or any governmental agency or political subdivision thereof.
"
PHSA
" has the meaning set forth in
Section 2.12(b)
.
"
Pre-Closing Period
" has the meaning set forth in
Section 4.1
.
"
Proxy Statement
" has the meaning set forth in
Section 5.1(a)
.
"
Registration Statement
" has the meaning set forth in
Section 5.1
.
"
Release
" means any releasing, disposing, discharging, injecting, spilling, leaking, pumping, dumping, emitting, escaping or emptying of a
Hazardous Material into the Environment.
"
Representatives
" means the directors, officers, employees, Affiliates, investment bankers, financial advisors, attorneys, accountants,
brokers, finders or representatives of the Company, Merger Sub, Saffron or any of their respective Subsidiaries, as the case may be.
"
Reverse Stock Split
" has the meaning set forth in
Section 5.15
.
"
Saffron
" has the meaning set forth in the Preamble.
"
Saffron Acceptable Confidentiality Agreement
" has the meaning set forth in
Section 4.5(b)
.
"
Saffron Acquisition Proposal
" has the meaning set forth in
Section 4.5(b)(ii)(A)
.
"
Saffron Ancillary Lease Documents
" means all subleases, overleases and other ancillary agreements or documents pertaining to the tenancy
at each such parcel of the Saffron Leased Real Property that materially affect or may materially affect the tenancy at any Saffron Leased Real Property.
"
Saffron Balance Sheet
" has the meaning set forth in
Section 3.13(b)
.
"
Saffron Business
" means the business of Saffron and any Subsidiary as currently conducted and currently proposed to be conducted.
"
Saffron Bylaws
" means the Restated By-laws of Saffron, as amended and in effect on the date hereof.
"
Saffron Change of Recommendation
" has the meaning set forth in
Section 4.5(b)(iii)
.
"
Saffron Change of Recommendation Notice
" has the meaning set forth in
Section 4.5(b)(iv)
.
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"
Saffron Charter
" means the Restated Certificate of Incorporation of Saffron, as amended and in effect on the date hereof.
"
Saffron Common Stock
" means the common stock, par value $0.001 per share, of Saffron.
"
Saffron Contract
" means any Contract together with any amendments, waivers or other modifications thereto, to which Saffron is a party.
"
Saffron Copyrights
" has the meaning set forth in
Section 3.9(a)
.
"
Saffron Contingent Workers
" has the meaning set forth in
Section 3.15(b)
.
"
Saffron Disclosure Schedule
" has the meaning set forth in
Section 3
.
"
Saffron Employee Programs
" has the meaning set forth in
Section 3.14(a)
.
"
Saffron Financial Statements
" has the meaning set forth in
Section 3.5(c)
.
"
Saffron Intellectual Property
" means all Intellectual Property owned by Saffron or any of its Subsidiaries or used or held for use by
Saffron or any of its Subsidiaries in the Saffron Business and all Saffron Products. "Saffron Intellectual Property" includes, without limitation, Saffron Products, Saffron Patents, Saffron Marks,
Saffron Copyrights and Saffron Trade Secrets.
"
Saffron Leased Real Property
" means the real property leased, subleased or licensed by Saffron, or any Subsidiary thereof, that is
related to or used in connection with the Saffron Business, and the real property leased, subleased or licensed by Saffron or any Subsidiary thereof, in each case, as tenant, subtenant, licensee or
other similar party, together with, to the extent leased, licensed or owned by Saffron or any Subsidiary thereof, all buildings and other structures, facilities or leasehold improvements, currently or
hereafter located thereon.
"
Saffron Leases
" means the lease, license, sublease or other occupancy agreements and all amendments, modifications, supplements, and
assignments thereto, together with all exhibits, addenda, riders and other documents constituting a part thereof for each parcel of Saffron Leased Real Property.
"
Saffron Licenses-In
" has the meaning set forth in
Section 3.9(a)
.
"
Saffron Licenses-Out
" has the meaning set forth in
Section 3.9(a)
.
"
Saffron Marks
" has the meaning set forth in
Section 3.9(a)
.
"
Saffron Material Adverse Effect
" means any change, circumstance, condition, development, effect, event, occurrence, result or state of
facts that, individually or when taken together with any other such change, circumstance, condition, development, effect, event, occurrence, result or state of facts, has or would reasonably be
expected to (a) have a material adverse effect on the business, financial condition, assets, liabilities or results of operations of Saffron and its Subsidiaries, taken as a whole, except that
none of the following shall be taken into account in determining whether there has been a Saffron Material Adverse Effect: (i) changes in general economic or political conditions or the
securities market in general (whether as a result of acts of terrorism, war (whether or not declared), armed conflicts or otherwise) to the extent they do not disproportionately affect Saffron and its
Subsidiaries, taken as a whole; (ii) changes in or affecting the industries in which Saffron operates to the extent they do not disproportionately affect Saffron and its Subsidiaries, taken as
a whole, in any material respect;
(iii) changes, effects or circumstances resulting from the announcement or pendency of this Agreement or the consummation of the Contemplated Transactions or compliance with the terms of this
Agreement; (iv) any specific action taken at the written request of the Company or expressly required by this Agreement; (v) any changes in or affecting research and development,
clinical trials or other drug development activities conducted by or on behalf of Saffron or its Subsidiaries in respect of Saffron Products or any other product candidates; (vi) continued
losses from operations or decreases in cash balances of Saffron or any of its Subsidiaries or on a consolidated basis among Saffron and its
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Subsidiaries;
and (vii) any reductions, either voluntary or involuntary, in Saffron's workforce; or (b) prevent or materially delay the ability of Saffron and Merger Sub to consummate
the Contemplated Transactions, in each case when viewed on a long-term or short-term basis. No change, circumstance, condition, development, effect, event, occurrence, result or state of facts
relating to the HSP Assets shall be taken into account in determining whether there has been a Saffron Material Adverse Effect.
"
Saffron Material Contract
" has the meaning set forth in
Section 3.10
.
"
Saffron Owned Real Property
" means the real property in which Saffron or any of its Subsidiaries has any fee title (or equivalent).
"
Saffron Patents
" has the meaning set forth in
Section 3.9(a)
.
"
Saffron Permits
" has the meaning set forth in
Section 3.12(b)
.
"
Saffron Preferred Stock
" means the preferred stock, par value $0.001 per share, of Saffron.
"
Saffron Products
" means ganetespib, STA-12-8666 and the other products described in the Saffron Patents.
"
Saffron Qualified Bidder
" has the meaning set forth in
Section 4.5(b)(i)
.
"
Saffron Recommendation
" has the meaning set forth in
Section 5.2(b)(ii)
.
"
Saffron Regulatory Agency
" has the meaning set forth in
Section 3.12(b)
.
"
Saffron Restricted Stock Award
" or "
Saffron Restricted Stock Awards
" means awards of
restricted stock issued under any of the Saffron Stock Option Plans.
"
Saffron Restricted Stock Unit Award
" or "
Saffron Restricted Stock Unit Awards
" means
awards of restricted stock units issued under any of the Saffron Stock Option Plans.
"
Saffron SEC Reports
" has the meaning set forth in
Section 3.5(a)
.
"
Saffron Stock Option Plans
" means Saffron's 2015 Stock Plan, Amended and Restated 2006 Stock Plan and 2001 Stock Plan.
"
Saffron Stock Options
" means options to purchase Saffron Common Stock issued under any of the Saffron Stock Option Plans.
"
Saffron Stockholder Approval
" has the meaning set forth in
Section 3.24
.
"
Saffron Stockholder Meeting
" has the meaning set forth in
Section 5.2(b)(i)
.
"
Saffron Stockholder Proposals
" has the meaning set forth in
Section 5.2(b)(i)
.
"
Saffron Stockholders
" shall mean the holders of the capital stock of Saffron immediately prior to the Effective Time.
"
Saffron Superior Offer
" has the meaning set forth in
Section 4.5(b)(ii)(B)
.
"
Saffron Trade Secrets
" has the meaning set forth in
Section 3.9(k)
.
"
Saffron Voting Agreements
" has the meaning set forth in the Recitals.
"
Sarbanes-Oxley Act
" means the Sarbanes-Oxley Act of 2002.
"
SEC
" means the Securities and Exchange Commission.
"
Securities Act
" means the Securities Act of 1933, as amended.
"
Subsidiary
" or "
Subsidiaries
" means, when used with reference to a party, any corporation
or other organization, whether incorporated or unincorporated, of which such party or any other
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subsidiary
of such party is a general partner (excluding partnerships the general partnership interests of which held by such party or any subsidiary of such party do not have a majority of the voting
interests in such partnership) or serves in a similar capacity, or, with respect to such corporation or other organization, at least 50% of the securities or other interests having by their terms
ordinary voting power to elect a majority of the board of directors or others performing similar functions is directly or indirectly owned or controlled by such party or by any one or more of its
subsidiaries, or by such party and one or more of its subsidiaries.
"
Surviving Corporation
" has the meaning set forth in
Section 1.1
.
"
Tax
" or "
Taxes
" means any and all taxes, customs, duties, tariffs, deficiencies,
assessments, levies, or other like governmental charges, including, without limitation, taxes based upon or measured by income, gross receipts, excise, real or personal property, ad valorem, value
added, estimated, alternative minimum, stamp, sales, withholding, social security (or similar), unemployment, disability, occupation, premium, windfall, use, service, service use, license, net worth,
payroll, pension, franchise, environmental (including taxes under Section 59A of the Code), severance, transfer, capital stock and recording taxes and charges, imposed by the IRS or any other
taxing authority (whether domestic or foreign including, without limitation, any state, county, local, or foreign government or any subdivision or taxing agency thereof (including a United States
possession)), whether computed on a separate, consolidated, unitary, combined, or any other basis; and such term shall include any interest, fines, penalties, or additional amounts attributable to, or
imposed upon, or with respect to, any such amounts,
whether disputed or not, and shall also include any obligations to indemnify or otherwise assume or succeed to the tax liability of any other Person.
"
Taxing Authority
" means any Governmental Authority responsible for the imposition of any Tax.
"
Tax Return
" means any report, return, document, declaration, election, schedule or other information or filing, or any amendment thereto,
required to be supplied to any taxing authority or jurisdiction (foreign or domestic) with respect to Taxes, including, without limitation, information returns and any documents with respect to or
accompanying payments of estimated Taxes or requests for the extension of time in which to file any such report, return, document, declaration, or other information.
"
Third Party Intellectual Property
" has the meaning set forth in
Section 2.9(f)
.
"
Voting Agreements
" has the meaning set forth in the Recitals.
"
WARN Act
" has the meaning set forth in
Section 2.15(b)
.
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EXHIBIT B
VOTING AGREEMENT
among:
SYNTA PHARMACEUTICALS CORP.,
a Delaware corporation;
MADRIGAL PHARMACEUTICALS, INC.,
a Delaware
corporation; and
the undersigned Stockholder
Dated as of
[
·
]
, April 2016
Table of Contents
TABLE OF CONTENTS
AB-i
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VOTING AGREEMENT
THIS VOTING AGREEMENT
("
Agreement
"),
dated as of [
·
], 2016, is made by and among Synta Pharmaceuticals Corp., a Delaware corporation
("
Synta
"), Madrigal Pharmaceuticals, Inc., a Delaware corporation (the "
Company
"), and the
undersigned holder ("
Stockholder
") of shares of capital stock (the "
Shares
") of Synta.
WHEREAS
, Synta, Saffron Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Synta
("
Merger Sub
"), and the Company, have entered into an Agreement and Plan of Merger and Reorganization, dated of even date herewith (in the form in
effect on the date hereof and attached hereto as
Exhibit A
or as amended pursuant to
Section 24
, the "
Merger
Agreement
"), providing for the merger of Merger Sub with and into the
Company (the "
Merger
");
WHEREAS
, Stockholder beneficially owns and has sole or shared voting power with respect to the number of Shares, and holds stock options
or other rights to acquire the number of Shares indicated opposite Stockholder's name on
Schedule 1
attached hereto;
WHEREAS
, as an inducement and a condition to the willingness of Synta, Merger Sub and the Company to enter into the Merger Agreement, and
in consideration of the substantial expenses incurred and to be incurred by them in connection therewith, Stockholder has agreed to enter into and perform this Agreement; and
WHEREAS
, all capitalized terms used in this Agreement without definition herein shall have the meanings ascribed to them in the Merger
Agreement.
NOW, THEREFORE
, in consideration of, and as a condition to, Synta's, Merger Sub's and the Company's entering into the Merger Agreement and
proceeding with the transactions contemplated thereby, and in consideration of the expenses incurred and to be incurred by them in connection therewith, Stockholder, Synta and the Company agree as
follows:
1.
Agreement to Vote Shares.
Stockholder agrees that, prior to the Expiration Date
(as defined in
Section 2
below), at any meeting of the stockholders of Synta or any adjournment or postponement thereof, or in connection with
any written consent of the stockholders of Synta, with respect to approval of the Merger as contemplated by the Merger Agreement and adoption of the Merger Agreement or any Saffron Acquisition
Proposal, Stockholder shall:
(a) appear
at such meeting or otherwise cause the Shares and any New Shares (as defined in
Section 3
below) to be
counted as present thereat for purposes of calculating a quorum; and
(b) vote
(or cause to be voted), or deliver a written consent (or cause a written consent to be delivered) covering all of the Shares and any New Shares that such
Stockholder shall be entitled to so vote: (i) in favor of (A) the adoption of the Merger Agreement and the approval of the Merger, including without limitation the issuance of the shares
of Saffron Common Stock by virtue of the Merger as contemplated by the Merger Agreement, and (B) an amendment to the Saffron Charter to effect the Reverse Stock Split; (ii) against any
action, proposal, transaction or agreement that, to the knowledge of Stockholder, would reasonably be expected to result in a breach in any material respect of any covenant, representation or warranty
or any other obligation or agreement of Synta under the Merger Agreement or that would reasonably be expected to result in any of the conditions to Synta's, Merger Sub's or the Company's obligations
under the Merger Agreement not being fulfilled; and (iii) against any Saffron Acquisition Proposal, or any agreement, transaction or other matter that is intended to, or would reasonably be
expected to, impede, interfere with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger and all other transactions contemplated by the Merger Agreement.
Stockholder shall not take or commit or agree to take any action inconsistent with the foregoing.
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2.
Expiration Date.
As used in this Agreement, the term
"
Expiration Date
" shall mean the earlier to occur of (a) the Effective Time, (b) such date and time as the Merger Agreement shall be
terminated pursuant to
Section 9
thereof or otherwise, or (c) upon mutual written agreement of the parties to terminate this Agreement.
Upon termination or expiration of this Agreement, no party shall have any further obligations or liabilities under this Agreement;
provided, however
,
such termination or expiration shall not relieve any party from liability for any willful breach of this Agreement or acts of bad faith prior to termination hereof.
3.
Additional Purchases.
Stockholder agrees that any shares of capital stock or
other equity securities of Synta that Stockholder purchases or with respect to which Stockholder otherwise acquires sole or shared voting power after the execution of this Agreement and prior to the
Expiration Date, whether by the exercise of any stock options or otherwise ("
New Shares
"), shall be subject to the terms and conditions of this
Agreement to the same extent as if they constituted the Shares.
4.
Agreement to Retain Shares.
From and after the date hereof until the Expiration
Date, Stockholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, offer, exchange, assign, pledge or otherwise dispose of (including, without limitation, by the creation
of any Liens (as defined in
Section 5(c)
below) on) any Shares, (b) deposit any Shares into a voting trust or enter into a voting
agreement or similar arrangement with respect to such Shares or grant any proxy or power of attorney with respect thereto (other than this Agreement), (c) enter into any contract, option,
commitment or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens
on) any Shares, or (d) take any action that would make any representation or warranty of Stockholder contained herein untrue or incorrect or have the effect of preventing or disabling
Stockholder from performing Stockholder's obligations under this Agreement. Notwithstanding the foregoing, Stockholder may make (a) transfers by will or by operation of law or other transfers
for estate-planning purposes, in which case this Agreement shall bind the transferee and transferee shall sign a voting agreement in substantially the form hereof, (b) with respect to such
Stockholder's Saffron Stock Options which expire on or prior to the Expiration Date, transfers, sale, or other disposition of Shares to Synta as payment for the (i) exercise price of such
Stockholder's Saffron Stock Options and (ii) taxes applicable to the exercise of such Stockholder's Saffron Stock Options, (c) if Stockholder is a partnership or limited liability
company, a transfer to one or more partners or members of Stockholder or to an affiliated corporation, trust or other business entity under common control with Stockholder, or if Stockholder is a
trust, a transfer to a beneficiary, provided that in each such case the applicable transferee has signed a voting agreement in substantially the form hereof relating to the transferred Shares,
(d) any transfer to another holder of the capital stock of the Company that has signed a voting agreement in substantially the form hereof relating to the transferred Shares, (e) any
transfer to a person if, as a condition precedent to the transfer, such person executes and delivers to the Company an agreement containing voting and transfer provisions with respect to the Shares so
transferred that are substantially identical in all material respects to those set forth in this Agreement; and (f) as the Company may otherwise agree in writing in its sole discretion.
5.
Representations and Warranties of Stockholder.
Stockholder hereby represents and
warrants to Synta and the Company as follows:
(a) Stockholder
has the full power and authority to execute and deliver this Agreement and to perform Stockholder's obligations hereunder;
(b) this
Agreement has been duly executed and delivered by or on behalf of Stockholder and assuming this Agreement constitutes a valid and binding agreement of the Company
and Synta, constitutes a valid and binding agreement with respect to Stockholder, enforceable against Stockholder in accordance with its terms, except as enforcement may be limited by general
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principles
of equity whether applied in a court of law or a court of equity and by bankruptcy, insolvency and similar laws affecting creditors' rights and remedies generally;
(c) except
as set forth on
Schedule 1
, Stockholder beneficially owns the number of Shares indicated opposite such
Stockholder's name on
Schedule 1,
and will own any New Shares, free and clear of any liens, claims, charges or other encumbrances or restrictions
of any kind whatsoever other than repurchase rights of the Company with respect to Saffron Restricted Stock Awards and Saffron Restricted Stock Unit Awards
("
Liens
"), and has sole or shared, and otherwise unrestricted, voting power with respect to such Shares and none of the Shares is subject to any voting
trust or other agreement, arrangement or restriction with respect to the voting of the Shares, except as contemplated by this Agreement;
(d) the
execution and delivery of this Agreement by Stockholder does not, and the performance by Stockholder of his or her obligations hereunder and the compliance by
Stockholder with any provisions hereof will not, violate or conflict with, result in a material breach of or constitute a default (or an event that with notice or lapse of time or both would become a
material default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Liens on any Shares pursuant to, any agreement,
instrument, note, bond, mortgage, contract, lease, license, permit or other obligation or any order, arbitration award, judgment or decree to which Stockholder is a party or by which Stockholder is
bound, or any law, statute, rule or regulation to which
Stockholder is subject or, in the event that Stockholder is a corporation, partnership, trust or other entity, any bylaw or other organizational document of Stockholder; and
(e) the
execution and delivery of this Agreement by Stockholder does not, and the performance of this Agreement by Stockholder does not and will not, require any consent,
approval, authorization or permit of, or filing with or notification to, any governmental or regulatory authority by Stockholder except for applicable requirements, if any, of the Exchange Act, and
except where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, would not prevent or delay the performance by Stockholder of his or
her obligations under this Agreement in any material respect.
6.
Irrevocable Proxy.
Subject to the penultimate sentence of this
Section 6
, by execution
of this Agreement, Stockholder does hereby appoint the Company with full power of substitution and resubstitution, as
Stockholder's true and lawful attorney and irrevocable proxy, to the fullest extent of the undersigned's rights with respect to the Shares, to vote, or give consent with respect to, each of such
Shares solely with respect to the matters set forth in
Section 1
hereof until the earlier of (a) the Expiration Date or (b) the
date on which any term or provision of the Merger Agreement described in
Section 24(a)
hereof is amended, waived or otherwise modified (the
"
Proxy Termination Date
"). Stockholder intends this proxy to be irrevocable and coupled with an interest hereunder until the Proxy Termination Date and
hereby revokes any proxy previously granted by Stockholder with respect to the Shares. Stockholder shall take such further action or execute such other instruments as may be necessary to effectuate
the intent of this proxy. Notwithstanding anything contained herein to the contrary, this irrevocable proxy shall automatically terminate upon the Proxy Termination Date. The Stockholder hereby
revokes any proxies previously granted and represents that none of such previously-granted proxies are irrevocable.
7.
No Solicitation
. From and after the date hereof until the Expiration Date,
Stockholder shall not (a) initiate, solicit, seek or knowingly encourage or support any inquiries, proposals or offers that constitute or may reasonably be expected to lead to, a Saffron
Acquisition Proposal, (b) engage or participate in, or knowingly facilitate, any discussions or negotiations regarding any inquiries, proposals or offers that constitute, or may reasonably be
expected to lead to, a Saffron Acquisition Proposal, (c) furnish to any Person other than the Company any non-public information that could reasonably be
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expected
to be used for the purposes of formulating any Saffron Acquisition Proposal, (d) enter into any letter of intent, agreement in principle or other similar type of agreement relating to
a Saffron Acquisition Proposal, or enter into any agreement or agreement in principle requiring Synta to abandon, terminate or fail to consummate the transactions contemplated hereby,
(e) initiate a stockholders' vote or action by consent of the Synta's stockholders with respect to a Saffron Acquisition Proposal, (f) except by reason of this Agreement, become a member
of a "group" (as such term is
defined in Section 13(d) of the Exchange Act) with respect to any voting securities of Synta that takes any action in support of a Saffron Acquisition Proposal or (g) propose or agree to
do any of the foregoing. In the event that Stockholder is a corporation, partnership, trust or other entity, it shall not permit any of its Subsidiaries or Affiliates to, nor shall it authorize any
officer, director or representative of Stockholder, or any of its Subsidiaries or Affiliates to, undertake any of the actions contemplated by this
Section 7
.
8.
Release; No Legal Actions.
The undersigned Stockholder acknowledges that the
release of certain claims by stockholders of Synta against the Company, Synta, Merger Sub and their respective affiliates constitutes a material inducement for the completion of the transactions
contemplated by the Merger Agreement and that the Company, Synta and Merger Sub would not enter into the Merger Agreement without being released from such claims by the undersigned Stockholder.
Effective as of the Effective Time, the undersigned Stockholder, and, to the extent within the undersigned's control, each of the undersigned's equity holders and each of their respective
subsidiaries, affiliates, employees, agents, advisors, heirs, legal representatives, successors and assigns (each, a "
Releasor
"), hereby completely
releases, acquits and forever discharges, to the fullest extent permitted by law Synta and its respective affiliates (including the Company, as the surviving company) and each of its current, former
and future officers, directors, employees, agents, advisors, successors and assigns (each, a "
Releasee
"), from any and all losses, liabilities, suits,
actions, debts or rights, whether fixed or contingent, known or unknown, matured or unmatured (collectively, "
Losses
"), arising out of, relating to, or
in any manner connected with any facts, events or circumstances, or any actions taken, at or prior to the Effective Time (the "
Release Date"
) that any
Releasor ever had or now has against the Releasees ("
Released Matters
"), excluding any Losses arising out of, relating to, or in any manner connected
with the Merger Agreement and the transactions contemplated thereby. Notwithstanding anything to the contrary in this Agreement, nothing herein shall release the Company or any of its Affiliates of
obligations to the undersigned Stockholder with respect to (A) any employment or consulting agreement, (B) any other employment-related obligations of the Company or any of its
Affiliates, (C) vested retirement benefits, (D) any rights that cannot be waived as a matter of law, (E) any indemnification obligations to the undersigned Stockholder under the
Company's or any of its Affiliates' bylaws, certificate of incorporation, or other organizational documents, or under Delaware law or otherwise, or (F) any rights relating to the undersigned's
relationship with the Company or any of its Affiliates (other than as a stockholder). The undersigned hereby waives the provisions of section 1542 of the California Civil Code, or any successor
thereto, which currently states: "A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if
known by him or her must have materially affected his or her settlement with the debtor." Effective as of the Release Date, the undersigned Stockholder shall not, and, to the extent within the
undersigned's control, shall not cause or permit its equity holders or any of their respective Subsidiaries, Affiliates, employees, agents, advisors, heirs, legal representatives, successors and
assigns, to assert any claims against the Releasees in respect of any Released Matters. The undersigned Stockholder acknowledges that it would be difficult to fully compensate Synta or any of its
Affiliates (including the Surviving Company) for damages resulting from any breach by him/her/it of the provisions of this release. Accordingly, in the event of any actual or threatened breach of such
provisions, Synta and its Affiliates (including the Surviving Company) shall (in addition to any other remedies which it may have) be entitled to seek temporary and/or permanent injunctive relief to
enforce such provisions and recover attorneys' fees and costs for same. The undersigned Stockholder
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further
acknowledges that this release constitutes a material inducement to Synta to complete the transactions contemplated by the Merger Agreement and Synta will be relying on the enforceability of
this release in completing such transactions contemplated by the Merger Agreement.
9.
Other Remedies; Specific Performance.
Except as otherwise provided herein, any
and all remedies herein expressly conferred upon a party will be deemed cumulative with, and not exclusive of, any other remedy conferred hereby, or by Law or equity upon such party, and the exercise
by a party of any one remedy will not preclude the exercise of any other remedy. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement
were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches
of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being the addition to any other remedy to which
they are entitled at Law or in equity.
10.
Directors and Officers.
This Agreement shall apply to Stockholder solely in
Stockholder's capacity as a stockholder of Synta and/or holder of options to purchase shares of Saffron Common Stock and not in such Stockholder's capacity as a director, officer or employee of Synta
or any of its Subsidiaries or in such Stockholder's capacity as a trustee or fiduciary of any employee benefit plan or trust. Notwithstanding any provision of this Agreement to the contrary, nothing
in this Agreement shall (or require Stockholder to attempt to) prohibit, limit, prevent, preclude or restrict a director and/or officer of Synta in the exercise of his or her fiduciary duties
consistent with the terms of the Merger Agreement as a director and/or officer of Synta or in his or her capacity as a trustee or fiduciary of any employee benefit plan or trust or prevent or be
construed to create any obligation on the part of any director and/or officer of Synta or any trustee or fiduciary of any employee benefit plan or trust from taking any action in his or her capacity
as such director, officer, trustee and/or fiduciary.
11.
No Ownership Interest.
Nothing contained in this Agreement shall be deemed to
vest in the Company any direct or indirect ownership or incidence of ownership of or with respect to any Shares. All rights, ownership and economic benefits of and relating to the Shares shall remain
vested in and belong to Stockholder, and the Company does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of Synta or
exercise any power or authority to direct Stockholder in the voting of any of the Shares, except as otherwise provided herein.
12.
Termination.
This Agreement shall terminate and shall have no further force or
effect as of the Expiration Date. Notwithstanding the foregoing, nothing set forth in this
Section 12
or elsewhere in this Agreement shall
relieve either party hereto from any liability, or otherwise limit the liability of either party from any liability for any intentional breach of any obligation or other provision contained in this
Agreement.
13.
Further Assurances.
Stockholder shall, from time to time, execute and deliver,
or cause to be executed and delivered, such additional or further consents, documents and other instruments as the Company or Synta may reasonably request for the purpose of effectively carrying out
the transactions contemplated by this Agreement and the Merger Agreement.
14.
Disclosure.
Stockholder hereby agrees that Synta and the Company may publish
and disclose in the Proxy Statement, any prospectus filed with any regulatory authority in connection with the Merger and any related documents filed with such regulatory authority and as otherwise
required by Law, such Stockholder's identity and ownership of Shares and the nature of such Stockholder's commitments, arrangements and understandings under this Agreement and may further file this
Agreement as an exhibit to the Proxy or prospectus or in any other filing made by Synta or the Company as required by Law or the terms of the Merger Agreement, including with the SEC or other
regulatory authority, relating to the Merger.
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15.
Notice.
All notices and other communications hereunder
shall be in writing and shall be deemed given if delivered personally or sent by overnight courier (providing proof of delivery) or by facsimile transmission (providing confirmation of transmission)
to the Company or Synta, as the case may be, in accordance with
Section 10.8
of the Merger Agreement and to each Stockholder at its address set
forth on
Schedule 1
attached hereto (or at such other address for a party as shall be specified by like notice).
16.
Severability.
Any term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the
offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is
invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such
term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall
be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term
or provision with
a valid and enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.
17.
Assignability.
This Agreement shall be binding upon, and shall be enforceable
by and inure solely to the benefit of, the parties hereto and their respective successors and assigns;
provided, however
, that neither this Agreement
nor any of a party's rights or obligations hereunder may be assigned or delegated by such party without the prior written consent of the other parties hereto, and any attempted assignment or
delegation of this Agreement or any of such rights or obligations by such party without the other party's prior written consent shall be void and of no effect. Nothing in this Agreement, express or
implied, is intended to or shall confer upon any Person (other than the parties hereto) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
18.
No Waivers.
No waivers of any breach of this Agreement extended by the Company
or Synta to Stockholder shall be construed as a waiver of any rights or remedies of the Company or Synta, as applicable, with respect to any other stockholder of Synta who has executed an agreement
substantially in the form of this Agreement with respect to Shares held or subsequently held by such stockholder or with respect to any subsequent breach of the Stockholder or any other such
stockholder of Synta. No waiver of any provisions hereof by any party shall be deemed a waiver of any other provisions hereof by any such party, nor shall any such waiver be deemed a continuing waiver
of any provision hereof by such party.
19.
Applicable Law; Jurisdiction.
This Agreement shall be governed by, and
construed in accordance with, the Laws of the State of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of Laws. In any action or proceeding
between any of the parties arising out of or relating to this Agreement, each of the parties: (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of
the Court of Chancery of the State of Delaware or to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court
for the District of Delaware, (ii) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (i) of this
Section 19
, (iii) waives any objection to laying venue in any such action or proceeding in such courts, (iv) waives any objection
that such courts are an inconvenient forum or do not have jurisdiction over any party, and (v) agrees that service of process upon such party in any such action or proceeding shall be effective
if notice is given in accordance with
Section 15
of this Agreement.
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20.
Waiver of Jury Trial.
The parties hereto hereby waive any right to trial by
jury with respect to any action or proceeding related to or arising out of this
Agreement, any document executed in connection herewith and the matters contemplated hereby and thereby.
21.
No Agreement Until Executed.
Irrespective of negotiations among the parties or
the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a contract, agreement, arrangement or understanding between the parties hereto unless and until
(a) the Synta Board has approved, for purposes of any applicable anti-takeover laws and regulations and any applicable provision of the Saffron Charter, the transactions contemplated by the
Merger Agreement, (b) the Merger Agreement is executed by all parties thereto, and (c) this Agreement is executed by all parties hereto.
22.
Entire Agreement; Counterparts; Exchanges by Facsimile.
This Agreement and the
other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the parties with
respect to the subject matter hereof and thereof. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same
instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all parties by facsimile or electronic transmission via ".pdf" shall be sufficient to bind the parties to the
terms and conditions of this Agreement.
23.
Amendment.
This Agreement may not be amended, supplemented or modified, and no
provisions hereof may be modified or waived, except by an instrument in writing signed on behalf of each party hereto.
24.
Definition of Merger Agreement.
For purposes of this Agreement, the term
"
Merger Agreement
" may include such agreement as amended or modified as long as such amendments or modifications (a) do not constitute an
amendment, waiver or modification of Section 1.5 (Conversion of Shares), or otherwise to the form of consideration, Exchange Ratio, whether or not such sections are actually amended, waived or
modified; or (b) have been agreed to in writing by Stockholder.
25.
Construction
.
(a) For
purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the
feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.
(b) The
parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the
construction or interpretation of this Agreement.
(c) As
used in this Agreement, the words "include" and "including," and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be
followed by the words "without limitation."
(d) Except
as otherwise indicated, all references in this Agreement to "Sections," "Exhibits" and "Schedules" are intended to refer to Sections of this Agreement and
Exhibits and Schedules to this Agreement, respectively.
(e) The
bold-faced headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred
to in connection with the construction or interpretation of this Agreement.
[
Remainder of Page has Intentionally Been Left Blank
]
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EXECUTED as of the date first above written.
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STOCKHOLDER
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By:
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Name:
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Title:
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[Signature
Page to Voting Agreement]
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EXECUTED
as of the date first above written.
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SYNTA PHARMACEUTICALS CORP.
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By:
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Name:
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Title:
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MADRIGAL PHARMACEUTICALS, INC.
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By:
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Name:
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Title:
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[Signature
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SCHEDULE 1
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Name and Address of Stockholder
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Shares
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Options
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Restricted Stock Units
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List of Signatories
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Chen Schor
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Marc Schneebaum
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Wendy Rieder
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Keith R. Gollust
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Keith R. Gollust IRA
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Wyandanch Partners, L.P.
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Bruce Kovner
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OB Select Opportunities
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SK2 Holdings, LLC
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SFK Master GRAT
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KFO Holding LLC
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Kovner 2015-A Investment Trust
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Kovner 2012 Family Trust B
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Donald W. Kufe, M.D.
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Scott Morenstein
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William S. Reardon, C.P.A.
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Robert N. Wilson
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EXHIBIT C
VOTING AGREEMENT
among:
MADRIGAL PHARMACEUTICALS, INC.,
a Delaware corporation;
SYNTA PHARMACEUTICALS CORP.,
a Delaware
corporation; and
the undersigned Stockholder
Dated as of April [
·
], 2016
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AC-i
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VOTING AGREEMENT
THIS VOTING AGREEMENT
("
Agreement
"),
dated as of April [
·
], 2016, is made by and among Synta Pharmaceuticals Corp., a Delaware corporation
("
Synta
"), Madrigal Pharmaceuticals, Inc., a Delaware corporation (the "
Company
"), and the
undersigned holder ("
Stockholder
") of shares of capital stock (the "
Shares
") of the Company.
WHEREAS
, Synta, Saffron Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Synta
("
Merger Sub
"), and the Company, have entered into an Agreement and Plan of Merger and Reorganization, dated of even date herewith (the
"
Merger Agreement
"), providing for the merger of Merger Sub with and into the Company (the "
Merger
");
WHEREAS
, Stockholder beneficially owns and has sole or shared voting power with respect to the number of Shares, and holds stock options
or other rights to acquire the number of Shares indicated opposite Stockholder's name on
Schedule 1
attached hereto;
WHEREAS
, as an inducement and a condition to the willingness of Synta, Merger Sub and the Company to enter into the Merger Agreement, and
in consideration of the substantial expenses incurred and to be incurred by them in connection therewith, Stockholder has agreed to enter into and perform this Agreement; and
WHEREAS,
all capitalized terms used in this Agreement without definition herein shall have the meanings ascribed to them in the Merger
Agreement.
NOW, THEREFORE
, in consideration of, and as a condition to, Synta's, Merger Sub's and the Company's entering into the Merger Agreement and
proceeding with the transactions contemplated thereby, and in consideration of the expenses incurred and to be incurred by them in connection therewith, Stockholder, Synta and the Company agree as
follows:
1.
Agreement to Vote Shares.
Stockholder agrees that, prior to the Expiration Date
(as defined in
Section 2
below), at any meeting of the stockholders of the Company or any adjournment or postponement thereof, or in connection
with any written consent of the stockholders of the Company, with respect to the Merger, the Merger Agreement or any Company Acquisition Proposal, Stockholder shall:
(a) appear
at such meeting or otherwise cause the Shares and any New Shares (as defined in
Section 3
below) to be
counted as present thereat for purposes of calculating a quorum; and
(b) vote
(or cause to be voted), or deliver a written consent (or cause a written consent to be delivered) covering all of the Shares and any New Shares that such
Stockholder shall be entitled to so vote: (i) in favor of adoption of the Merger Agreement and the approval of the Merger; (ii) against any action, proposal, transaction or agreement
that, to the knowledge of Stockholder, would reasonably be expected to result in a breach in any material respect of any covenant, representation or warranty or any other obligation or agreement of
the Company under the Merger Agreement or that would reasonably be expected to result in any of the conditions to Synta's, Merger Sub's or the Company's obligations under the Merger Agreement not
being fulfilled; and (iii) against any Company Acquisition Proposal, or any agreement, transaction or other matter that is intended to, or would reasonably be expected to, impede, interfere
with, delay, postpone, discourage or materially and adversely affect the consummation of the Merger and all other transactions contemplated by the Merger Agreement. The Stockholder shall not take or
commit or agree to take any action inconsistent with the foregoing.
2.
Expiration Date.
As used in this Agreement, the term
"
Expiration Date
" shall mean the earlier to occur of (a) the Effective Time, (b) such date and time as the Merger Agreement shall be
terminated pursuant to
Section 9
thereof or otherwise, or (c) upon mutual written agreement of the parties to terminate this Agreement.
Upon termination or expiration of this Agreement, no party shall
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have
any further obligations or liabilities under this Agreement; provided, however, such termination or expiration shall not relieve any party from liability for any willful breach of this Agreement
or acts of bad faith prior to termination hereof.
3.
Additional Purchases.
Stockholder agrees that any shares of capital stock or
other equity securities of the Company that Stockholder purchases or with respect to which Stockholder otherwise acquires sole or shared voting power after the execution of this Agreement and prior to
the Expiration Date, whether by the exercise of any stock options or otherwise ("
New Shares
"), shall be subject to the terms and conditions of this
Agreement to the same extent as if they constituted the Shares.
4.
Agreement to Retain Shares.
From and after the date hereof until the Expiration
Date, Stockholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, offer, exchange, assign, pledge or otherwise dispose of (including, without limitation, by the creation
of any Liens (as defined in
Section 5(c)
below) on) any Shares, (b) deposit any Shares into a voting trust or enter into a voting
agreement or similar arrangement with respect to such Shares or grant any proxy or power of attorney with respect thereto (other than this Agreement), (c) enter into any contract, option,
commitment or other arrangement or understanding with respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens
on) any Shares, or (d) take any action that would make any representation or warranty of Stockholder contained herein untrue or incorrect or have the effect of preventing or disabling
Stockholder from performing Stockholder's obligations under this Agreement. Notwithstanding the foregoing, Stockholder may make (a) transfers by will or by operation of law or other transfers
for estate-planning purposes, in which case this Agreement shall bind the transferee and transferee shall sign a voting agreement in substantially the form hereof, (b) with respect to such
Stockholder's Company Options which expire on or prior to the Expiration Date, transfers, sale, or other disposition of Shares to the Company as payment for the (i) exercise price of such
Stockholder's Company Options and (ii) taxes applicable to the exercise of such Stockholder's Company Options, (c) if Stockholder is a partnership or limited liability company, a
transfer to one or more partners or members of Stockholder or to an affiliated corporation, trust or other business entity under common control with Stockholder, or if Stockholder is a trust, a
transfer to a beneficiary, provided that in each such case the applicable transferee has signed a voting agreement in substantially the form hereof relating to the transferred Shares, (d) any
transfer to another holder of the capital stock of the Company that has signed a voting agreement in substantially the form hereof relating to the transferred Shares, and (e) as Synta may
otherwise agree in writing in its sole discretion.
5.
Representations and Warranties of Stockholder.
Stockholder hereby represents and
warrants to Synta and the Company as follows:
(a) Stockholder
has the full power and authority to execute and deliver this Agreement and to perform Stockholder's obligations hereunder;
(b) this
Agreement has been duly executed and delivered by or on behalf of Stockholder and, assuming this Agreement constitutes a valid and binding agreement of the Company
and Synta, constitutes a valid and binding agreement with respect to Stockholder, enforceable against Stockholder in accordance with its terms, except as enforcement may be limited by general
principles of equity whether applied in a court of law or a court of equity and by bankruptcy, insolvency and similar laws affecting creditors' rights and remedies generally;
(c) except
as set forth on
Schedule 1
, Stockholder beneficially owns the number of Shares indicated opposite such
Stockholder's name on
Schedule 1
, and will own any New Shares, free and clear of any liens, claims, charges or other encumbrances or restrictions
of any kind whatsoever ("
Liens
"), and has sole or shared, and otherwise unrestricted, voting power with respect to such Shares and none of the Shares is
subject to any voting trust or other agreement, arrangement or restriction with respect to the voting of the Shares, except as contemplated by this Agreement;
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(d) the
execution and delivery of this Agreement by Stockholder does not, and the performance by Stockholder of his or her obligations hereunder and the compliance by
Stockholder with any provisions hereof will not, violate or conflict with, result in a material breach of or constitute a default (or an event that with notice or lapse of time or both would become a
material default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, or result in the creation of any Liens on any Shares pursuant to, any agreement,
instrument, note, bond, mortgage, contract, lease, license, permit or other obligation or any order, arbitration award, judgment or decree to which Stockholder is a party or by which Stockholder is
bound, or any law, statute, rule or regulation to which Stockholder is subject or, in the event that Stockholder is a corporation, partnership, trust or other entity, any bylaw or other organizational
document of Stockholder; and
(e) the
execution and delivery of this Agreement by Stockholder does not, and the performance of this Agreement by Stockholder does not and will not, require any consent,
approval, authorization or permit of, or filing with or notification to, any governmental or regulatory authority by Stockholder except for applicable requirements, if any, of the Exchange Act, and
except where the failure to obtain such consents, approvals, authorizations or permits, or to make such filings or notifications, would not
prevent or delay the performance by Stockholder of his or her obligations under this Agreement in any material respect.
6.
Irrevocable Proxy.
Subject to the penultimate sentence of this Section 6,
by execution of this Agreement, Stockholder does hereby appoint Synta with full power of substitution and resubstitution, as Stockholder's true and lawful attorney and irrevocable proxy, to the
fullest extent of the undersigned's rights with respect to the Shares, to vote, or give consent with respect to, each of such Shares solely with respect to the matters set forth in
Section 1
hereof. Stockholder intends this proxy to be irrevocable and coupled with an interest hereunder until the Expiration Date and hereby
revokes any proxy previously granted by Stockholder with respect to the Shares. Stockholder shall take such further action or execute such other instruments as may be necessary to effectuate the
intent of this proxy. Notwithstanding anything contained herein to the contrary, this irrevocable proxy shall automatically terminate upon the Expiration Date of this Agreement. The Stockholder hereby
revokes any proxies previously granted and represents that none of such previously-granted proxies are irrevocable.
7.
No Solicitation
. From and after the date hereof until the Expiration Date,
Stockholder shall not (a) initiate, solicit, seek or knowingly encourage or support any inquiries, proposals or offers that constitute or may reasonably be expected to lead to, a Company
Acquisition Proposal, (b) engage or participate in, or knowingly facilitate, any discussions or negotiations regarding any inquiries, proposals or offers that constitute, or may reasonably be
expected to lead to, a Company Acquisition Proposal, (c) furnish to any Person other than the Company any non-public information that could reasonably be expected to be used for the purposes of
formulating any Company Acquisition Proposal, (d) enter into any letter of intent, agreement in principle or other similar type of agreement relating to a Company Acquisition Proposal, or enter
into any agreement or agreement in principle requiring the Company to abandon, terminate or fail to consummate the transactions contemplated hereby, (e) initiate a stockholders' vote or action
by consent of the Company's stockholders with respect to a Company Acquisition Proposal, (f) except by reason of this Agreement, become a member of a "group" (as such term is defined in
Section 13(d) of the Exchange Act) with respect to any voting securities of the Company that takes any action in support of a Company Acquisition Proposal or (g) propose or agree to do
any of the foregoing. In the event that Stockholder is a corporation, partnership, trust or other entity, it shall not permit any of its Subsidiaries or Affiliates to, nor shall it authorize any
officer, director or representative of Stockholder, or any of its Subsidiaries or Affiliates to, undertake any of the actions contemplated by this
Section 7
.
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8.
Waiver of Appraisal Rights; Release; No Legal Actions
.
(a) The
Stockholder hereby waives, and agrees not to exercise or assert, any appraisal rights under applicable law, including Section 262 of the DGCL in connection
with the Merger.
(b) The
undersigned Stockholder acknowledges that the release of certain claims by stockholders of the Company against the Company, Synta, Merger Sub and their respective
affiliates constitutes a material inducement for the completion of the transactions contemplated by the Merger Agreement and that the Company, Synta and Merger Sub would not enter into the Merger
Agreement without being released from such claims by the undersigned Stockholder. The undersigned Stockholder, and, to the extent within the undersigned's control, each of the undersigned's equity
holders and each of their respective subsidiaries, affiliates, employees, agents, advisors, heirs, legal representatives, successors and assigns (each, a
"
Releasor
"), hereby completely releases, acquits and forever discharges, to the fullest extent permitted by law, the Company, Synta, Merger Sub, the
Surviving Corporation and their respective affiliates and each of their respective current, former and future officers, directors, employees, agents, advisors, successors and assigns (each, a
"
Releasee
"), from any and all losses, liabilities, suits, actions, debts or rights, whether fixed or contingent, known or unknown, matured or unmatured,
arising out of, relating to, or in any manner connected with any facts, events or circumstances, or any actions taken, at or prior to the effective time of the Merger (the
"
Effective Time
") that any Releasor ever had or now has against the Releasees ("
Released Matters
"),
excluding any rights of the Releasor under the Merger Agreement. Notwithstanding anything to the contrary in this Agreement, nothing herein shall release the Company or any of its Affiliates of
obligations to the undersigned Stockholder with respect to (A) any employment or consulting agreement, (B) any other employment-related obligations of the Company or any of its
Affiliates, (C) vested retirement benefits, (D) any rights that cannot be waived as a matter of law, (E) any indemnification obligations to the undersigned Stockholder under the
Company's or any of its Affiliates' bylaws, certificate of incorporation, or other organizational documents, or under Delaware law or otherwise, or (F) any rights relating to the undersigned's
relationship with the Company or any of its Affiliates (other than as a stockholder). The undersigned hereby waives the provisions of section 1542 of the California Civil Code, or any successor
thereto, which currently states: "A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if
known by him or her must have materially affected his or her settlement with the debtor." Effective as of the Effective Time, the undersigned Stockholder shall not, and, to the extent within the
undersigned's control, shall not cause or permit its equity holders or any of their respective Subsidiaries, Affiliates, employees, agents, advisors, heirs, legal representatives, successors and
assigns, to assert any claims against the Releasees in respect of any Released Matters. The undersigned Stockholder acknowledges that it would be difficult to fully compensate Synta or any of its
Affiliates (including the Surviving Corporation) for damages resulting from any breach by him/her/it of the provisions of this release. Accordingly, in the event of any actual or threatened breach of
such provisions, Synta and its Affiliates (including the Surviving Corporation) shall (in addition to any other remedies which it may have) be entitled to seek temporary and/or permanent injunctive
relief to enforce such provisions and recover attorneys' fees and costs for same. The undersigned Stockholder further acknowledges that this release constitutes a material inducement to Synta to
complete the transactions contemplated by the Merger Agreement and Synta will be relying on the enforceability of this release in completing such transactions contemplated by the Merger Agreement.
(c) The
Stockholder will not in its capacity as a stockholder of the Company bring, commence, institute, maintain, prosecute or voluntarily aid any Legal Proceeding which
(i) challenges the validity or seeks to enjoin the operation of any provision of this Agreement or (ii) alleges that the execution and delivery of this agreement by the Stockholder,
either alone or
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together
with the other voting agreements and proxies to be delivered in connection with the execution of the Merger Agreement, or the approval of the Merger Agreement by the Board of Directors of the
Company, constitutes a breach of any fiduciary duty of the Board of Directors of the Company or any member thereof.
9.
Other Remedies; Specific Performance.
Except as otherwise provided herein, any
and all remedies herein expressly conferred upon a party will be deemed cumulative with, and not exclusive of, any other remedy conferred hereby, or by Law or equity upon such party, and the exercise
by a party of any one remedy will not preclude the exercise of any other remedy. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement
were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches
of this Agreement and to enforce specifically the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being the addition to any other remedy to which
they are entitled at Law or in equity.
10.
Directors and Officers.
This Agreement shall apply to Stockholder solely in
Stockholder's capacity as a stockholder of the Company and/or holder of options to purchase shares of Company Common Stock and/or holder of securities convertible into shares of Company Common Stock
and not in such Stockholder's capacity as a director, officer or employee of the Company or any of its Subsidiaries or in such Stockholder's capacity as a trustee or fiduciary of any employee benefit
plan or trust. Notwithstanding any provision of this Agreement to the contrary, nothing in this Agreement shall (or require Stockholder to attempt to) limit or restrict a director and/or officer of
the Company in the exercise of his or her fiduciary duties consistent with the terms of the Merger Agreement as a director and/or officer of the Company or in his or her capacity as a trustee or
fiduciary of any employee benefit plan or trust or prevent or be construed to create any obligation on the part of any director and/or officer of the Company or any trustee or fiduciary of any
employee benefit plan or trust from taking any action in his or her capacity as such director, officer, trustee and/or fiduciary.
11.
No Ownership Interest.
Nothing contained in this Agreement shall be deemed to
vest in Synta any direct or indirect ownership or incidence of ownership of or with respect to any Shares. All rights, ownership and economic benefits of and relating to the Shares shall remain vested
in and belong to Stockholder, and Synta does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of the Company or exercise
any power or authority to direct Stockholder in the voting of any of the Shares, except as otherwise provided herein.
12.
Termination.
This Agreement shall terminate and shall have no further force or
effect as of the Expiration Date. Notwithstanding the foregoing, nothing set forth in this
Section 12
or elsewhere in this Agreement shall
relieve either party hereto from any liability, or otherwise limit the liability of either party from any liability for any intentional breach of any obligation or other provision contained in this
Agreement.
13.
Further Assurances.
Stockholder shall, from time to time, execute and deliver,
or cause to be executed and delivered, such additional or further consents, documents and other instruments as the Company or Synta may reasonably request for the purpose of effectively carrying out
the transactions contemplated by this Agreement and the Merger Agreement.
14.
Disclosure.
Stockholder hereby agrees that Synta and the Company may publish
and disclose in the Proxy Statement, any prospectus filed with any regulatory authority in connection with the Merger and any related documents filed with such regulatory authority and as otherwise
required by Law, such Stockholder's identity and ownership of Shares and the nature of such Stockholder's commitments, arrangements and understandings under this Agreement and may further file this
Agreement as an exhibit to the Proxy or prospectus or in any other filing made by Synta or the Company as required by Law or the terms of the Merger Agreement, including with the SEC or other
regulatory authority, relating to the Merger.
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15.
Notice.
All notices and other communications hereunder
shall be in writing and shall be deemed given if delivered personally or sent by overnight courier (providing proof of delivery) or by facsimile transmission (providing confirmation of transmission)
to the Company or Synta, as the case may be, in accordance with
Section 10.8
of the Merger Agreement and to each Stockholder at its address set
forth on
Schedule 1
attached hereto (or at such other address for a party as shall be specified by like notice).
16.
Severability.
Any term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions of this Agreement or the validity or enforceability of the
offending term or provision in any other situation or in any other jurisdiction. If a final judgment of a court of competent jurisdiction declares that any term or provision of this Agreement is
invalid or unenforceable, the parties hereto agree that the court making such determination shall have the power to limit such term or provision, to delete specific words or phrases or to replace such
term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall
be valid and enforceable as so modified. In the event such court does not exercise the power granted to it in the prior sentence, the parties hereto agree to replace such invalid or unenforceable term
or provision with a valid and
enforceable term or provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term or provision.
17.
Assignability.
This Agreement shall be binding upon, and shall be enforceable
by and inure solely to the benefit of, the parties hereto and their respective successors and assigns; provided, however, that neither this Agreement nor any of a party's rights or obligations
hereunder may be assigned or delegated by such party without the prior written consent of the other parties hereto, and any attempted assignment or delegation of this Agreement or any of such rights
or obligations by such party without the other party's prior written consent shall be void and of no effect. Nothing in this Agreement, express or implied, is intended to or shall confer upon any
Person (other than the parties hereto) any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
18.
No Waivers.
Except as set forth in
Section 23
, no waivers of any breach of this
Agreement extended by the Company or Synta to Stockholder shall be construed as a waiver of any
rights or remedies of the Company or Synta, as applicable, with respect to any other stockholder of the Company who has executed an agreement substantially in the form of this Agreement with respect
to Shares held or subsequently held by such stockholder or with respect to any subsequent breach of the Stockholder or any other such stockholder of the Company. No waiver of any provisions hereof by
any party shall be deemed a waiver of any other provisions hereof by any such party, nor shall any such waiver be deemed a continuing waiver of any provision hereof by such party.
19.
Applicable Law; Jurisdiction.
This Agreement shall be governed by, and
construed in accordance with, the Laws of the State of Delaware, regardless of the Laws that might otherwise govern under applicable principles of conflicts of Laws. In any action or proceeding
between any of the parties arising out of or relating to this Agreement, each of the parties: (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of
the Court of Chancery of the State of Delaware or to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court
for the District of Delaware, (ii) agrees that all claims in respect of such action or proceeding shall be heard and determined exclusively in accordance with clause (i) of this
Section 19
, (iii) waives any objection to laying venue in any such action or proceeding in such courts, (iv) waives any objection
that such courts are an inconvenient forum or do not have jurisdiction over any party, and (v) agrees that service of process upon such party in any such action or proceeding shall be effective
if notice is given in accordance with
Section 15
of this Agreement.
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20.
Waiver of Jury Trial.
The parties hereto hereby waive any right to trial by
jury with respect to any action or proceeding related to or arising out of this
Agreement, any document executed in connection herewith and the matters contemplated hereby and thereby.
21.
No Agreement Until Executed.
Irrespective of negotiations among the parties or
the exchanging of drafts of this Agreement, this Agreement shall not constitute or be deemed to evidence a contract, agreement, arrangement or understanding between the parties hereto unless and until
(a) the Board of Directors of the Company has approved, for purposes of any applicable anti-takeover laws and regulations and any applicable provision of the Company Charter, the transactions
contemplated by the Merger Agreement, (b) the Merger Agreement is executed by all parties thereto, and (c) this Agreement is executed by all parties hereto.
22.
Entire Agreement; Counterparts; Exchanges by Facsimile.
This Agreement and the
other agreements referred to in this Agreement constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among or between any of the parties with
respect to the subject matter hereof and thereof. This Agreement may be executed in several counterparts, each of which shall be deemed an original and all of which shall constitute one and the same
instrument. The exchange of a fully executed Agreement (in counterparts or otherwise) by all parties by facsimile or electronic transmission via ".pdf' shall be sufficient to bind the parties to the
terms and conditions of this Agreement.
23.
Amendment.
This Agreement may not be amended, supplemented or modified, and no
provisions hereof may be modified or waived, except by an instrument in writing signed on behalf of each party hereto. In the event that securities held by any other holder (the
"
Other Holder
") subject to a similar voting agreement in connection with the Merger is released from the restrictions of such voting agreement, the
Shares held by the Stockholder shall likewise automatically be released from the restrictions contained herein in the same proportion as those securities released for the Other Holder.
24.
Definition of Merger Agreement.
For purposes of this Agreement, the term
"
Merger Agreement
" may include such agreement as amended or modified as long as such amendments or modifications (a) do not (i) change the
form of consideration or (ii) change the Exchange Ratio in a manner adverse to Stockholder, or (b) have been agreed to in writing by Stockholder.
25.
Construction.
(a) For
purposes of this Agreement, whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the
feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter gender shall include masculine and feminine genders.
(b) The
parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the
construction or interpretation of this Agreement.
(c) As
used in this Agreement, the words "include" and "including," and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be
followed by the words "without limitation."
(d) Except
as otherwise indicated, all references in this Agreement to "Sections," "Exhibits" and "Schedules" are intended to refer to Sections of this Agreement and
Exhibits and Schedules to this Agreement, respectively.
(e) The
bold-faced headings contained in this Agreement are for convenience of reference only, shall not be deemed to be a part of this Agreement and shall not be referred
to in connection with the construction or interpretation of this Agreement.
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EXECUTED as of the date first above written.
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STOCKHOLDER
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EXECUTED
as of the date first above written.
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SYNTA PHARMACEUTICALS CORP.
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Title:
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MADRIGAL PHARMACEUTICALS, INC.
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By:
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SCHEDULE 1
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Name and Address of Stockholder
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Shares
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Options
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Other Rights
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List of Signatories
Fred
Craves, Ph.D.
Rebecca Taub, M.D.
Bay City Capital Fund IV, L.P.
Bay City Capital Fund IV Co-Investment Fund, L.P.
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EXHIBIT D
LOCK-UP AGREEMENT
Synta
Pharmaceuticals Corp.
45 Hartwell Avenue
Lexington, MA 02421
Madrigal
Pharmaceuticals, Inc.
500 Office Center Drive, Suite 400
Fort Washington, PA 19034
Ladies
and Gentlemen:
In
connection with the proposed acquisition of Madrigal Pharmaceuticals, Inc. (the "
Company
") by Synta Pharmaceuticals Corp.
("
Synta
") whereby Saffron Merger Sub, Inc. ("
Merger Sub
"), a wholly-owned subsidiary of Synta,
will merge with and into the Company (the "
Merger
"), and in consideration of Synta, Merger Sub and the Company entering into the Agreement and Plan of
Merger and Reorganization dated on or about April [
·
], 2016 (the "
Merger
Agreement
;" all capitalized terms used in this Lock-Up Agreement without definition herein shall have the meanings ascribed to them in the Merger Agreement), the receipt and
sufficiency of such consideration being hereby acknowledged and accepted, and in order to induce Synta and the Company each to close the Merger, the undersigned
("
Securityholder
"), a holder of shares of Company Capital Stock and/or Convertible Debt (the "
Company
Securities
") who will receive shares of Saffron Common Stock in exchange for his, her or its shares of Company Securities hereby agrees with Synta and the Company as follows:
1. During
the Lock-Up Period (as defined below), Securityholder shall not, directly or indirectly, (a) sell, assign, transfer, tender, or otherwise dispose of
(whether by actual disposition or effective economic disposition due to cash settlement or otherwise, including, without limitation, by the creation of any liens, claims, charges or other encumbrances
or restrictions of any kind whatsoever ("
Liens
") on) any (i) Company Securities and (ii) shares of Saffron Common Stock and any securities
convertible into, exchangeable for or that represent the right to receive shares of Saffron Common Stock, in each case whether now owned or hereinafter acquired, owned directly by the Securityholder
(including holding as a custodian) or with respect to which the Securityholder has beneficial ownership within the rules and regulations of the Securities and Exchange Commission (collectively, the
"
Locked-Up Securities
"), (b) effect any short sale or enter into any contract, option, commitment or other arrangement or understanding with
respect to the direct or indirect sale, transfer, assignment or other disposition of (including, without limitation, by the creation of any Liens or by establishing or increasing a put equivalent
position or liquidating or decreasing a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended (the "
Exchange
Act
"), and the rules and regulations of the Securities and Exchange Commission promulgated thereunder with respect to, any Locked-Up Securities, or publicly announce an
intention to effect any such transaction, during the Lock-Up Period) any Locked-Up Securities, or (c) take any action that would make any representation or warranty of Securityholder contained
herein untrue or incorrect or have the effect of preventing or disabling Securityholder from performing Securityholder's obligations under this Lock-Up Agreement. Notwithstanding the foregoing, and
provided that transfers described in (a) through (f) of this sentence
are not required to be reported in any public report or filing with the Securities and Exchange Commission (other than (i) a filing at any time on a Form 5 or (ii) a filing after
the expiration of the Lock-Up Period on a Schedule 13D or Schedule 13G (or Schedule 13D/A or Schedule 13G/A), Securityholder may make (a) transfers as a
bona fide
gift or gifts
(b) transfers by will or by operation of law or other transfers for estate-planning purposes, in which case this Lock-Up
Agreement shall bind the transferee, (c) with respect to such Securityholder's Company Options which expire on or prior to the Expiration Date, transfers, sale, or other disposition of
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Locked-Up
Securities to the Company as payment for the (i) exercise price of such Securityholder's Company Options and (ii) taxes applicable to the exercise of such Securityholder's
Company Options or (d) if Securityholder is a partnership or limited liability company, a transfer to one or more partners or members of Securityholder or to an affiliated corporation, trust or
other business entity under common control with Securityholder, or if Securityholder is a trust, a transfer to a beneficiary, provided that in each such case the applicable transferee has signed a
lock-up agreement in substantially the form hereof, (e) any transfer to another holder of the capital stock of the Company that has signed a lock-up agreement in substantially the form hereof
relating to the transferred Shares and (f) transfers of shares acquired on the open market following the Closing Date. In the event that any securities held by any other holder (the
"
Other Holder
") subject to a similar lock-up agreement in connection with the Merger are released from the restrictions of such lock-up agreement, the
Locked-Up Securities held by the undersigned Securityholder shall likewise automatically be released from the restrictions contained herein in the same proportion as those securities released for the
Other Holder.
2. As
used in this Lock-Up Agreement, the term "
Lock-Up Period
" shall mean from and after the date hereof until the earlier
to occur of (a) 180 days after the Closing Date or (b) such date and time as the Merger Agreement shall be terminated pursuant to
Section 9
thereof or otherwise. Upon termination or
expiration of this Lock-Up Agreement, no party shall have any further obligations or
liabilities under this Lock-Up Agreement;
provided
,
however
, such termination or expiration shall not
relieve any party from liability for any willful breach of this Lock-Up Agreement or acts of bad faith prior to termination hereof.
3. Securityholder
also agrees and consents to the entry of stop transfer instructions with Synta's transfer agent and registrar against the transfer of Securityholders'
Locked-Up Securities, except in compliance with this Lock-Up Agreement. In furtherance of the foregoing, Synta and its transfer agent are hereby authorized to decline to make any transfer of
securities if such transfer would constitute a violation or breach of this Lock-Up Agreement.
4. Securityholder
understands that Synta, the Company and Merger Sub will proceed with the Merger in reliance on this Lock-Up Agreement. Moreover, Securityholder understands
and agrees that Synta, Merger Sub and the Company are relying upon the accuracy, completeness, and truth of Securityholder's representations, warranties, agreements, and certifications contained in
this Lock-Up Agreement.
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Date: ,
2016
If
an individual, please sign here:
If
a corporation, a limited partnership or other legal entity, please sign here:
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Date: ,
2016
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SYNTA PHARMACEUTICALS CORP.
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MADRIGAL PHARMACEUTICALS, INC.
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EXHIBIT E
RESTATED CERTIFICATE OF INCORPORATION
OF
[SURVIVING CORPORATION]
FIRST
: The name of the corporation (hereinafter called the "Corporation") is
[SURVIVING CORPORATION]
SECOND
: The address, including street, number, city, and county, of the registered office of the Corporation in the State of Delaware is
2711
Centerville Road, Suite 400, City of Wilmington, County of New Castle, Delaware 19808; and the name of the registered agent of the Corporation in the State of Delaware is Corporation Service
Company.
THIRD
: The nature of the business to be conducted and the purposes of the Corporation are to engage in any lawful act or activity or
carry on any
business for which corporations may be organized under the Delaware General Corporation Law or any successor statute.
FOURTH
: The total number of shares of all classes of stock which the Corporation shall have authority to issue is One Thousand (1,000),
consisting of
1,000 shares of Common Stock, $.0001 Par Value per share (the "Common Stock").
FIFTH
: The Corporation is to have perpetual existence.
SIXTH
: For the management of the business and for the conduct of the affairs of the Corporation, and in further definition and not in
limitation of
the powers of the Corporation and of its directors and of its stockholders or any class thereof, as the case may be, conferred by the State of Delaware, it is further provided that:
A. The
management of the business and the conduct of the affairs of the Corporation shall be vested in its Board of Directors. The number of directors which shall constitute
the whole Board of Directors shall be fixed by, or in the manner provided in, the By-Laws. The phrase "whole Board" and the phrase "total number of directors" shall be deemed to have the same meaning,
to wit, the total number of directors which the Corporation would have if there were no vacancies. No election of directors need be by written ballot.
B. After
the original or other By-Laws of the Corporation have been adopted, amended or repealed, as the case may be, in accordance with the provisions of Section 109
of the General Corporation Law of the State of Delaware, and, after the Corporation has received any payment for any of its stock, the power to adopt, amend, or repeal the By-Laws of the Corporation
may be exercised by the Board of Directors of the Corporation.
C. The
books of the Corporation may be kept at such place within or without the State of Delaware as the By-Laws of the Corporation may provide or as may be designated from
time to time by the Board of Directors of the Corporation.
SEVENTH
: The Corporation shall, to the fullest extent permitted by Section 145 of the General Corporation Law of the State of
Delaware, as the
same may be amended and supplemented from time to time, indemnify and advance expenses to, (i) its directors and officers, and (ii) any person who at the request of the Corporation is or
was serving as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, from and against any and all of the expenses, liabilities, or other
matters referred to in or covered by said section as amended or supplemented (or any successor), provided, however, that except with respect to proceedings to enforce rights to indemnification, the
By-Laws of the Corporation may provide that the Corporation shall
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indemnify
any director, officer or such person in connection with a proceeding (or part thereof) initiated by such director, officer or such person only if such proceeding (or part thereof) was
authorized by the Board of Directors of the Corporation. The Corporation, by action of its Board of Directors, may provide indemnification or advance expenses to employees and agents of the
Corporation or other persons only on such terms and conditions and to the extent determined by the Board of Directors in its sole and absolute discretion. The indemnification provided for herein shall
not be deemed exclusive of any other rights to which those indemnified may be entitled under any By-Law, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in
their official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased to be a director, officer, employee, or agent and shall inure
to the benefit of the heirs, executors and administrators of such a person.
EIGHTH
: No director of this Corporation shall be personally liable to the Corporation or its stockholders for monetary damages for
breach of
fiduciary duty as a director except to the extent that exemption from liability or limitation thereof is not permitted under the General Corporation Law of the State of Delaware as in effect at the
time such liability or limitation thereof is determined. No amendment, modification or repeal of this Article shall apply to or have any effect on the liability or alleged liability of any director of
the Corporation for or with respect to any acts or omissions of such director occurring prior to such amendment, modification or repeal. If the General Corporation Law of the State of Delaware is
amended after approval by the stockholders of this Article to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the
Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law of the State of Delaware, as so amended.
NINTH
: Whenever a compromise or arrangement is proposed between this Corporation and its creditors or any class of them and/or between
this
Corporation and its stockholders or any class of them, any court of equitable jurisdiction within the State of Delaware may, on the application in a summary way of this Corporation or of any creditor
or stockholder thereof or on the application of any receiver or receivers appointed for this Corporation under the provisions of Section 291 of Title 8 of the Delaware Code or on the
application of trustees in dissolution or of any receiver or receivers appointed for this Corporation under the provisions of Section 279 of Title 8 of the Delaware Code, order a meeting of the
creditors or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, to be summoned in such manner as the said court directs. If a majority in
number representing three-fourths (
3
/
4
) in value of the creditors or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be,
agree to any compromise or arrangement and to any reorganization of this Corporation as consequence of such compromise or arrangement, the said compromise or arrangement and the said reorganization
shall, if sanctioned by the court to which the said application has been made, be binding on all the creditors or class of creditors, and/or on all the stockholders or class of stockholders, of this
Corporation, as the case may be, and also on this Corporation.
TENTH
: From time to time any of the provisions of this Restated Certificate of Incorporation may be amended, altered or repealed, and
other
provisions authorized by the laws of the State of Delaware at the time in force may be added or inserted in the manner and at the time prescribed by said laws, and all rights at any time conferred
upon the stockholders of the Corporation by this Restated Certificate of Incorporation are granted subject to the provisions of this Article.
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EXHIBIT F
ACTION BY WRITTEN CONSENT
OF THE STOCKHOLDERS OF
MADRIGAL PHARMACEUTICALS, INC.,
a Delaware corporation
April 13, 2016
In accordance with Section 228(a) and Section 251(c) of the Delaware General Corporation Law (the
"
DGCL
"), the Certificate of Incorporation and the Bylaws of Madrigal Pharmaceuticals, Inc., a Delaware corporation (the
"
Corporation
"), the undersigned, constituting the holders (the "
Stockholders
") of all of the outstanding
shares of capital stock of the Corporation ("
Common Stock
"), do hereby adopt the following recitals and resolutions by written consent, which action
shall be as valid and legal and of the same force and effect as though taken at a meeting duly and validly noticed and held.
Adoption of the Merger Agreement and Approval of the Merger
WHEREAS, the Corporation has entered into an Agreement and Plan of Merger and Reorganization, dated April 13, 2016 attached
hereto as
Exhibit A
(the "
Merger Agreement
"), by and among Synta Pharmaceuticals, Inc., a
Delaware corporation ("
Synta
"), Merger Sub, a Delaware corporation and wholly owned subsidiary of Synta ("
Merger
Sub
"), and the Corporation, under which Merger Sub will merge with and into the Corporation, with the Corporation surviving as a wholly-owned subsidiary of Synta (the
"
Merger
"), upon the terms and subject to the conditions set forth in the Merger Agreement (each capitalized term used but not otherwise defined herein
having the meaning ascribed to such term in the Merger Agreement);
WHEREAS,
subject to the terms of the Merger Agreement, each share of capital stock of the Corporation (other than dissenting shares) shall be cancelled and automatically converted into
the right to receive a number of shares of Synta common stock equal to the Exchange Ratio (the "
Merger Shares
");
WHEREAS,
the board of directors of the Corporation (the "
Board
") has unanimously resolved that the Merger is fair to, advisable and in the
best interests of the Corporation and its Stockholders and, as such, has adopted the Merger Agreement (including all such other agreements, exhibits, schedules, documents and certificates proposed to
be delivered in connection therewith, including the ancillary
agreements to which the Corporation is a party, if any (the "
Ancillary Agreements
" and together with the Merger Agreement, the
"
Transaction Documents
") and has approved the Merger and recommended that the Stockholders adopt and approve the same;
WHEREAS,
each of the undersigned has (i) been furnished with, or provided access, to all information requested by such Stockholder relating to the Merger Agreement, the Merger and
the other transactions contemplated therein and had the opportunity to ask questions and obtain answers from the Corporation and (ii) reviewed the terms of the Merger Agreement and such other
information as such Stockholder believes to be necessary to make an informed decision in connection therewith, and has had the opportunity to consult withhis, her or its own legal, tax and financial
advisors regarding the consequences to such Stockholder of the Merger, the Merger Agreement, the execution of these resolutions, and the consummation of the transactions contemplated thereby and
hereby; and
WHEREAS,
after carefully considering all of the foregoing factors (including the interests of the officers, directors, and their affiliates in the transactions contemplated by the Merger
Agreement), each of the undersigned Stockholders believes it to be in the best interests of the Corporation and its
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Stockholders
to adopt the Merger Agreement and approve the Merger and the other transactions contemplated by the Merger Agreement.
NOW,
THEREFORE, BE IT RESOLVED, that the undersigned Stockholders hereby consent to, ratify and adopt the form, terms and provisions of the Merger Agreement and such other Transaction
Documents;
RESOLVED
FURTHER, that the undersigned Stockholders hereby consent to and ratify the execution, delivery and performance of the Merger Agreement and such other Transaction Documents; and
RESOLVED
FURTHER, that the undersigned Stockholders hereby approve the Merger and the other transactions contemplated by the Merger Agreement and the other Transaction Documents.
Approval of Certificate of Amendment of Amended and Restated Certificate of Incorporation
WHEREAS, the
Board
has recommended to the undersigned that the Corporation adopt a
Certificate of Amendment of Amended and Restated Certificate of Incorporation, in substantially the form attached hereto as
Exhibit B
and
incorporated herein by reference (the "
Certificate of Amendment
"), which provides for an increase in the authorized number of shares of Common Stock
from an aggregate of 35,000,000 to 50,000,000, all as more fully set forth in the Certificate of Amendment; and
WHEREAS,
the Board has approved the Certificate of Amendment and deems it to be advisable and in the best interests of the Corporation and its Stockholders that the Stockholders approve
the Certificate of Amendment.
NOW
THEREFORE, BE IT RESOLVED, that the form, terms and provisions of the Certificate of Amendment, and any other documents to be executed and delivered in connection therewith, be, and
the same hereby are, approved and adopted.
Release of Claims Relating to Information Statement
WHEREAS, in connection with the Merger, and pursuant to the DGCL, the undersigned are entitled to an information statement setting
forth certain items relating to the Merger; and
WHEREAS,
each of the undersigned acknowledge that approval of this Written Consent will constitute a waiver of his, her, or its rights to receive such an information statement.
NOW,
THEREFORE, BE IT RESOLVED, that the undersigned hereby irrevocably waives his, her, or its rights to receive an information statement in connection with the Merger;
RESOLVED
FURTHER, that the undersigned agrees to release all claims against the Corporation of every nature and kind, known or unknown, suspected or unsuspected, arising from or
attributable to the omission of receiving an information statement.
Ratification of Interested Party Transaction
WHEREAS, each of the undersigned is aware that (i) Rebecca Taub
("
Dr. Taub
"), a director and officer of the Corporation, currently holds shares of the Corporation's capital stock and Notes (as defined below)
that may convert into shares of the Corporation's capital stock and will be receiving a portion of the Merger Shares in connection with the Merger and a bonus payment payable upon the successful
consummation of the Merger; (ii) Fred Craves ("
Dr. Craves
"), a director of the Corporation, is affiliated with and has a material
financial interest in Bay City Capital Fund IV, L.P. and Bay City Capital Fund IV Co-Investment Fund, L.P., which currently hold shares of the Corporation's capital stock and Notes that
may convert into shares of the Corporation's capital stock and such entities will
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be
receiving a portion of the Merger Shares in connection with the Merger; and (iii) Lionel Carnot ("
Mr. Carnot
"), a director of the
Corporation, is affiliated with and has a material financial interest in Bay City Capital Fund IV, L.P. and Bay City Capital Fund IV Co-Investment Fund, L.P., which currently hold shares
of the Corporation's capital stock and Notes that may convert into shares of the Corporation's capital stock and such entities will be receiving a portion of the Merger Shares in connection with the
Merger, in each case upon the successful consummation of the Merger (any such contract or transaction in clauses (i) - (iii) is referred to herein as an
"
Interested Directors' and Officer's Transaction
") and that, accordingly, Dr. Taub, Dr. Craves, and Mr. Carnot are "interested
directors" and Dr. Taub is an "interested officer" as described in Subdivision (a) of Section 144 of the DGCL;
WHEREAS,
Section 144 of the DGCL provides that a transaction between a corporation and one or more of its directors or officers or a corporation and another entity in which one or
more of its directors or officers has a financial interest or is an officer or director shall not be void or voidable provided that either: (i) the material facts of that transaction are
disclosed or known to the board of directors and the board of directors authorizes the transaction by a majority of the disinterested directors of the board; (ii) the material facts of that
transaction are disclosed or known to the stockholders and the stockholders authorize the transaction by a vote of the stockholders; or (iii) the transaction is fair to the corporation as of
the time it is authorized, approved or ratified by the board of directors, a committee thereof or the stockholders of a corporation;
WHEREAS,
the undersigned have been fully apprised of all of the material facts relevant to the Interested Directors' and Officer's Transaction; and
WHEREAS,
the undersigned Stockholders have reviewed the terms and conditions of the Merger Agreement and deem the Merger Agreement and the Merger to be fair to, advisable and in the best
interests of the Corporation and all of its Stockholders.
NOW,
THEREFORE, BE IT RESOLVED, that the undersigned Stockholders have been fully apprised of all of the material facts of the Interested Directors' and Officer's Transaction and upon
thorough review and consideration of the terms and conditions of the Merger, the Merger Agreement, and the transactions contemplated thereby, and the relationship between the Corporation and each of
the interested directors and the interested officer, has determined that the Interested Directors' and Officer's Transactions are advisable, fair to and in the best interests of the Corporation and
its Stockholders and as such, ratifies the same.
General Authority and Ratification of Past Actions
RESOLVED, that the officers of the Corporation be, and each of them hereby is, authorized, empowered and directed, in the name and on
behalf of the Corporation, to prepare, execute, deliver and file or cause to be prepared, executed, delivered and filed such further agreements, certificates, instruments and documents, to pay all
expenses and to take such actions as contemplated by the Merger Agreement and the other Transaction Documents or as such officer or officers deem necessary, appropriate or advisable to carry out the
intent of the foregoing resolutions, including, but not limited to, to effect the Merger;
RESOLVED
FURTHER, that the officers of the Corporation be, and each of them hereby is, authorized to approve such changes or modifications to any of the documents and agreements
authorized or approved in the foregoing resolutions, as such officer or officers may deem necessary or advisable, such approval to be conclusively evidenced by the execution or delivery thereof;
RESOLVED
FURTHER, that any and all actions taken by any director or officer of the Corporation prior to the adoption of the foregoing resolutions intended to carry out the intent or
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accomplish
the purposes of the foregoing resolutions be, and hereby are, ratified, confirmed, approved and adopted in all respects;
RESOLVED
FURTHER, that the officers of the Corporation be, and each of them hereby is, authorized to certify and deliver a copy of these resolutions, or any one or more of them, to such
persons, firms or corporations as may be deemed necessary or advisable;
RESOLVED
FURTHER, that any officer of the Corporation be, and hereby is, authorized and directed to file these resolutions with the minutes of the proceedings of the Stockholders of the
Corporation and to file it with the Corporation's corporate records; and
RESOLVED
FURTHER, that these resolutions adopted by the undersigned may be executed in counterparts, including electronically transmitted counterparts, and each such counterpart shall be
deemed an original, and all of which, when taken together, shall constitute but one and the same instrument.
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IN WITNESS WHEREOF
, the undersigned Stockholders of the Corporation hereby consent, with respect to all shares of the Corporation's
capital stock held by the undersigned, to the foregoing resolutions and actions and direct that this Action by Written Consent be filed with the minutes of the Corporation. Said resolutions and
actions shall have the same force and effect as if they were adopted at a meeting at which the undersigned were personally present.
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Rebecca Taub, M.D.
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By:
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BAY CITY CAPITAL FUND IV, L.P.
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By:
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Bay City Capital Management IV LLC
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Its:
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General Partner
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By:
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Bay City Capital LLC
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Its:
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Manager
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By:
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Name:
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Fred Craves
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Title:
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Managing Director
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BAY CITY CAPITAL FUND IV CO-INVESTMENT FUND, L.P.
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By:
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Bay City Capital Management IV LLC
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Its:
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General Partner
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By:
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Bay City Capital LLC
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Its:
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Manager
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By:
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Name:
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Fred Craves
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Title:
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Managing Director
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Annex B
April 13,
2016
Board
of Directors
Synta Pharmaceuticals Corp.
45 Hartwell Avenue
Lexington, Massachusetts 02421
Dear Sirs:
You
have requested our opinion as to the fairness, from a financial point of view, to Synta Pharmaceuticals Corp. ("Synta") of the Consideration (as defined
below) to be paid by Synta pursuant to the terms of the proposed Agreement and Plan of Merger and Reorganization (the "Merger Agreement") to be entered into by and among Synta, Saffron Merger
Sub, Inc. ("Merger Sub") and Madrigal Pharmaceuticals, Inc. (the "Company").
As
more specifically set forth in the Merger Agreement, and subject to the terms, conditions and adjustments set forth therein, the Merger Agreement provides for the acquisition of the
Company through the merger of Merger Sub with and into the Company with Synta as the surviving entity thereof (the "Merger"). By virtue of the Merger, each share of common stock, par value $0.0001 per
share, of the Company issued and outstanding immediately prior to the effective time of the Merger (other than shares held in the Company's treasury and any Dissenting Shares (as defined in the Merger
Agreement)) will be converted into the right to receive a number of shares of common stock, par value $0.001 per share, of Synta ("Synta Common Stock") equal to the exchange ratio set forth in the
Merger Agreement. The total number of shares of Synta Common Stock issued by Synta in the Merger is referred to herein as (the "Consideration").
In
connection with our review of the proposed Merger, and in arriving at our opinion, we have: (i) reviewed a draft of the Merger Agreement dated April 8, 2016 (the "Draft
Merger Agreement"); (ii) reviewed the proposed terms of the concurrent Company Private Placement described in the Merger Agreement; (iii) reviewed certain information, including
financial forecasts, relating to the business, earnings, cash flow, assets, liabilities and prospects of Synta and the Company that were furnished to us by Synta; (iv) conducted discussions
with members of senior management and representatives of Synta and the Company concerning the matters described in clauses (ii) and (iii); (v) discussed the past and current operations
and financial condition and the prospects of Synta and the Company with members of senior management of Synta and of the Company, respectively; (vi) reviewed the financial terms, to the extent
publicly available, of certain acquisition and financing transactions that we deemed relevant; and (vii) performed such other analyses and considered such other factors as we deemed appropriate
for the purpose of rendering our opinion.
We
have relied upon and assumed, without assuming liability or responsibility for independent verification, the accuracy and completeness of all information that was publicly available
or was furnished, or otherwise made available, to us or discussed with or reviewed by or for us. We have further assumed that the financial information provided has been prepared on a reasonable basis
in accordance with industry practice, and that management of Synta is not aware of any information or facts that would make any information provided to us incomplete or misleading. Without limiting
the generality of the foregoing, for the purpose of this opinion, we have assumed that with respect to financial forecasts, estimates and other forward-looking information reviewed by us, that such
information has been reasonably prepared based on assumptions reflecting the best currently available
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estimates
and judgments of the management of Synta as to the expected future combined results of operations and financial condition of the Synta and the Company after giving effect to the Merger. We
express no opinion as to any such financial forecasts, estimates or forward-looking information or the assumptions on which they were based.
In
connection with our opinion, we have assumed and relied upon, without independent verification, the accuracy and completeness of all of the financial, legal, regulatory, tax,
accounting and other information provided to, discussed with or reviewed by us. Our opinion does not address any legal, regulatory, tax or accounting issues.
In
arriving at our opinion, we have assumed that the executed Merger Agreement will be in all material respects identical to the Draft Merger Agreement reviewed by us, including the
terms of the concurrent Company Private Placement. We have relied upon and assumed, without independent verification, that (i) the representations and warranties of all parties set forth in the
Merger Agreement and all related documents and instruments that are referred to therein are true and correct, (ii) each party to the Merger Agreement will fully and timely perform all of the
covenants and agreements required to be performed by such party, (iii) the Merger will be consummated pursuant to the terms of the Merger Agreement without amendments thereto, and
(iv) all conditions to the consummation of the Merger will be satisfied without waiver by any party of any conditions or obligations thereunder. Additionally, we have assumed that all the
necessary regulatory approvals and consents required for the Merger, including the approval of the stockholders of Synta and the Company, will be obtained in a manner that will not adversely affect
Synta or the Company or the contemplated benefits of the Merger.
In
arriving at our opinion, we have not performed any appraisals or valuations of any specific assets or liabilities (fixed, contingent or other) of Synta or the Company, and have not
been furnished or provided with any such appraisals or valuations. Without limiting the generality of the foregoing, we have undertaken no independent analysis of any pending or threatened litigation,
regulatory action,
possible unasserted claims or other contingent liabilities, to which Synta, the Company or any of their respective affiliates is a party or may be subject, and at the direction of Synta and with its
consent, our opinion makes no assumption concerning, and therefore does not consider, the possible assertion of claims, outcomes or damages arising out of any such matters.
This
opinion is necessarily based upon the information available to us and facts and circumstances as they exist and are subject to evaluation on the date hereof; events occurring after
the date hereof could materially affect the assumptions used in preparing this opinion. We are not expressing any opinion herein as to the price at which shares of Synta Common Stock may trade
following announcement of the Merger or at any future time. We have not undertaken to reaffirm or revise this opinion or otherwise comment upon any events occurring after the date hereof and do not
have any obligation to update, revise or reaffirm this opinion.
We
have been engaged by Synta to act as its financial advisor and we will receive a fee from Synta for providing such services, including the provision of this opinion. Our fee is not
contingent upon the consummation of the Merger. Synta has also agreed to indemnify us against certain liabilities and reimburse us for certain expenses in connection with our services. In March 2015,
we acted as a co-manager of a public offering by Synta of shares of its common stock and received substantial fees in connection therewith. In the future, we may also provide other financial advisory
and investment banking services to Synta and its affiliates for which we would expect to receive compensation. In addition, in the ordinary course of our business, we and our affiliates may actively
trade securities of Synta for our own account or the account of our customers and, accordingly, may at any time hold a long or short position in such securities.
Consistent
with applicable legal and regulatory requirements, Roth Capital Partners, LLC has adopted policies and procedures to establish and maintain the independence of our
research
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departments
and personnel. As a result, our research analysts may hold views, make statements or investment recommendations and/or publish research reports with respect to Synta, the Company and/or
the Merger that differ from the views of our investment banking personnel.
This
opinion has been prepared solely for the information of the Board of Directors of Synta for its use in connection with its consideration of the Merger and is not intended to be and
does not constitute a recommendation to any stockholder of Synta as to how such stockholder should vote on any matter relating to the Merger or any other matter. Except with respect to the inclusion
of this opinion in Synta's proxy statement relating to the Merger in accordance with our engagement letter with Synta, this opinion shall not be disclosed, referred to, published or otherwise used (in
whole or in
part), nor shall any public references to us be made, without our prior written approval. This opinion has been approved for issuance by the Roth Capital Partners, LLC Fairness Opinion
Committee.
This
opinion addresses only the fairness, from a financial point of view, to Synta of the proposed Consideration to be paid by Synta in the Merger and does not address the relative
merits of the Merger or any alternatives to the Merger, Synta's underlying decision to proceed with or effect the Merger, or any other aspect of the Merger. This opinion does not address the fairness
of the Merger to the holders of any class of securities, creditors or other constituencies of Synta. This opinion is not a valuation of Synta or the Company or their respective assets or any class of
their securities. We are not experts in, nor do we express an opinion on, legal, tax, accounting or regulatory issues. We do not express an opinion about the fairness of the amount or nature of any
compensation payable or to be paid to any of the officers, directors or employees, of the Company, whether or not relative to the Merger.
Based
upon and subject to the foregoing, it is our opinion that, as of the date hereof, the Consideration to be paid by Synta in the Merger is fair, from a financial point of view, to
Synta.
Sincerely,
Roth
Capital Partners, LLC
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Annex C
CERTIFICATE OF AMENDMENT OF
RESTATED CERTIFICATE OF INCORPORATION
OF
SYNTA PHARMACEUTICAL CORP.
(Pursuant to Section 242 of the
General
Corporation Law of the State of Delaware)
It
is hereby certified that:
-
1.
-
The
name of the corporation (hereinafter called the "Corporation") is Synta Pharmaceuticals Corp.
-
2.
-
The
Restated Certificate of Incorporation filed on February 9, 2007, as amended, is hereby further amended as follows:
-
A.
-
To
change the capitalization of the Corporation by adding the following paragraph to Article FOURTH, Section A of the Restated Certificate of
Incorporation immediately following the paragraph set forth in Article FOURTH, Section A of the Restated Certificate of Incorporation:
"Upon
the effectiveness of the Certificate of Amendment of Restated Certificate of Incorporation, to effect a plan of recapitalization of the Common Stock by effecting a
[ ]-for-1 reverse stock split with respect to the issued and outstanding shares of the Common Stock (the "Reverse Stock Split"), without any change in the powers,
preferences and rights or qualifications, limitations or restrictions thereof, such that, without further action of any kind on the part of the Corporation or its stockholders, every
[ ] ([ ]) shares of Common Stock outstanding or held by the Corporation in its treasury on the date of the filing of the
Certificate of Amendment (the "Effective Date") shall be changed and reclassified into one (1) share of Common Stock, $0.0001 par value per share, which shares shall be fully paid and
nonassessable shares of Common Stock. There shall be no fractional shares issued. A holder of record of Common Stock on the Effective Date who would otherwise be entitled to a fraction of a share
shall, in lieu thereof, be entitled to receive a cash payment in an amount equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing price of the Common
Stock, as reported in the Wall Street Journal, on the last trading day prior to the Effective Date (or if such price is not available, the average of the last bid and asked prices of the Common Stock
on such day or other price determined by the Corporation's board of directors)."
-
3.
-
The
Amendment of the Restated Certificate of Incorporation, as amended, herein certified has been duly adopted in accordance with the provisions of
Section 242 of the General Corporation Law of the State of Delaware.
EXECUTED,
this day of [ ] 2016.
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Synta Pharmaceuticals Corp.
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By:
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Chen Schor
President and Chief Executive Officer
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Annex D
SYNTA PHARMACEUTICALS CORP.
AMENDED 2015 STOCK PLAN
-
1.
-
DEFINITIONS
.
Unless
otherwise specified or unless the context otherwise requires, the following terms, as used in this Synta Pharmaceuticals Corp. Amended 2015 Stock Plan, have the following
meanings:
Administrator
means the Board of Directors, unless it has delegated power to act on its behalf to the Committee, in which case the Administrator means
the Committee.
Affiliate
means a corporation which, for purposes of Section 424 of the Code, is a parent or subsidiary of the Company, direct or indirect.
Agreement
means an agreement between the Company and a Participant pertaining to a Stock Right delivered pursuant to the Plan, in such form as the
Administrator shall approve.
Board of Directors
means the Board of Directors of the Company.
Cause
means, with respect to a Participant (a) dishonesty with respect to the Company or any Affiliate, (b) insubordination, substantial
malfeasance or non-feasance of duty, (c) unauthorized disclosure of confidential information, (d) breach by a Participant of any provision of any employment, consulting, advisory,
nondisclosure, non-competition or similar agreement between the Participant and the Company or any Affiliate, and (e) conduct substantially prejudicial to the business of the Company or any
Affiliate; provided, however, that any provision in an agreement between a Participant and the Company or an Affiliate, which contains a conflicting definition of Cause for termination and which is in
effect at the time of such termination, shall supersede this definition with respect to that Participant. The determination of the Administrator as to the existence of Cause will be conclusive on the
Participant and the Company.
Change of Control
means the occurrence of any of the following events:
-
(i)
-
Ownership.
Any "Person" (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the "Beneficial Owner" (as defined in
Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing 50% or more of the total voting power represented by the Company's then outstanding voting
securities (excluding for this purpose any such voting securities held by the Company or its Affiliates or by any employee benefit plan of the Company) pursuant to a transaction or a series of related
transactions which the Board of Directors does not approve; or
-
(ii)
-
Merger/Sale
of Assets. (A) A merger or consolidation of the Company whether or not approved by the Board of Directors, other than a merger or
consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into
voting securities of the surviving entity or the parent of such corporation) more than 50% of the total voting power represented by the voting securities of the Company or such surviving entity or
parent of such corporation, as the case may be, outstanding immediately after such merger or consolidation; or (B) the sale or disposition by the Company of all or substantially all of the
Company's assets in a transaction requiring shareholder approval; or
-
(iii)
-
Change
in Board Composition. A change in the composition of the Board of Directors, as a result of which fewer than a majority of the directors are
Incumbent Directors.
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"Incumbent
Directors" shall mean directors who either (A) are directors of the Company as of the date of adoption of the Plan, or (B) are elected, or nominated for election, to the Board
of Directors with the affirmative votes of at least a majority of the Incumbent Directors at the time of such election or nomination (but shall not include an individual whose election or nomination
is in connection with an actual or threatened proxy contest relating to the election of directors to the Company).
provided,
that if any payment or benefit payable hereunder upon or following a Change of Control would be required to comply with the limitations of Section 409A(a)(2)(A)(v) of the Code in
order to avoid an additional tax under Section 409A of the Code, such payment or benefit shall be made only if such Change in Control constitutes a change in ownership or control of the
Company, or a change in ownership of the Company's assets in accordance with Section 409A of the Code
Code
means the United States Internal Revenue Code of 1986, as amended including any successor statute, regulation and guidance thereto.
Committee
means the committee of the Board of Directors to which the Board of Directors has delegated power to act under or pursuant to the provisions
of the Plan, the composition of which shall at all times satisfy the provisions of Section 162(m) of the Code.
Common Stock
means shares of the Company's common stock, $.0001 par value per share.
Company
means Synta Pharmaceuticals Corp., a Delaware corporation.
Consultant
means any natural person who is an advisor or consultant that provides bona fide services to the Company or its Affiliates, provided that
such services are not in connection with the offer or sale of securities in a capital raising transaction, and do not directly or indirectly promote or maintain a market for the Company's or its
Affiliates' securities.
Disability
or
Disabled
means permanent and total disability as defined in Section 22(e)(3) of the
Code.
Employee
means any employee of the Company or of an Affiliate (including, without limitation, an employee who is also serving as an officer or director
of the Company or of an Affiliate), designated by the Administrator to be eligible to be granted one or more Stock Rights under the Plan.
Exchange Act
means the Securities Exchange Act of 1934, as amended.
Fair Market Value
of a Share of Common Stock means:
(1) If
the Common Stock is listed on a national securities exchange or traded in the over-the-counter market and sales prices are regularly reported for the Common Stock,
the closing or, if not applicable, the last price of the Common Stock on the composite tape or other comparable reporting system for the trading day on the applicable date and if such applicable date
is not a trading day, the last market trading day prior to such date;
(2) If
the Common Stock is not traded on a national securities exchange but is traded on the over-the-counter market, if sales prices are not regularly reported for the
Common Stock for the trading day referred to in clause (1), and if bid and asked prices for the Common Stock are regularly reported, the mean between the bid and the asked price for the Common
Stock at the close of trading in the over-the-counter market for the trading day on which Common Stock was traded on the applicable date and if such applicable date is not a trading day, the last
market trading day prior to such date; and
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(3) If
the Common Stock is neither listed on a national securities exchange nor traded in the over-the-counter market, such value as the Administrator, in good faith, shall
determine in compliance with applicable laws.
ISO
means an option intended to qualify as an incentive stock option under Section 422 of the Code.
Non-Qualified Option
means an option which is not intended to qualify as an ISO.
Option
means an ISO or Non-Qualified Option granted under the Plan.
Participant
means an Employee, director or Consultant of the Company or an Affiliate to whom one or more Stock Rights are granted under the Plan. As
used herein, "Participant" shall include "Participant's Survivors" where the context requires.
Performance-Based Award
means a Stock Grant or Stock-Based Award which vests based on the attainment of written Performance Goals as set forth in
Paragraph 9 hereof.
Performance Goals
means performance goals based on one or more of the following criteria: (i) pre-tax income or after-tax income;
(ii) income or earnings including operating income, earnings before or after taxes, interest, depreciation, amortization, and/or extraordinary or special items; (iii) net income
excluding amortization of intangible assets, depreciation and impairment of goodwill and intangible assets and/or excluding charges attributable to the adoption of new accounting pronouncements;
(iv) earnings or book value per share (basic or diluted); (v) return on assets (gross or net), return on investment, return on capital, return on invested capital or return on equity;
(vi) return on revenues; (vii) cash flow, free cash flow, cash flow return on investment (discounted or otherwise), net cash provided by operations, or cash flow in excess of cost of
capital; (viii) economic value created; (ix) operating margin or profit margin; (x) stock price or total shareholder return; (xi) income or earnings from continuing
operations; (xii) cost targets, reductions and savings, expense management, productivity and efficiencies; (xiii) operational objectives, consisting of one or more objectives based on
achieving progress in research and development programs or achieving regulatory milestones related to development and/or approval of products; and (xiv) strategic business criteria, consisting
of one or more objectives based on meeting specified market penetration or market share of one or more products or customers, geographic business expansion, customer satisfaction, employee
satisfaction, human resources management, supervision of litigation, information technology, and goals relating to acquisitions, divestitures, joint ventures and similar transactions. Where
applicable, the Performance Goals may be expressed in terms of a relative measure against a set of identified peer group companies, attaining a specified level of the particular criterion or the
attainment of a percentage increase or decrease in the particular criterion, and may be applied to one or more of the Company or an Affiliate of the Company, or a division or strategic business unit
of the Company, all as determined by the Committee. The Performance Goals may include a threshold level of performance below which no Performance-Based Award will be issued or no vesting will occur,
levels of performance at which Performance-Based Awards will be issued or specified vesting will occur, and a maximum level of performance above which no additional issuances will be made or at which
full vesting will occur. Each of the foregoing Performance Goals shall be evaluated in an objectively determinable manner in accordance with Section 162(m) of the Code and in accordance with
generally accepted accounting principles, where applicable, unless otherwise specified by the Committee, and shall be subject to certification by the Committee. The Committee shall have the authority
to make equitable adjustments to the Performance Goals in recognition of unusual or non-recurring events affecting the Company or any Affiliate or the financial statements of the Company or any
Affiliate, in response to changes in applicable laws or regulations, or to account for items of gain, loss or expense determined to be
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extraordinary
or unusual in nature or infrequent in occurrence or related to the disposal of a segment of a business or related to a change in accounting principles provided that any such change shall
at all times satisfy the provisions of Section 162(m) of the Code.
Plan
means this Synta Pharmaceuticals Corp. Amended 2015 Stock Plan.
Securities Act
means the Securities Act of 1933, as amended.
Shares
means shares of the Common Stock as to which Stock Rights have been or may be granted under the Plan or any shares of capital stock into which
the Shares are changed or for which they are exchanged within the provisions of Paragraph 3 of the Plan. The Shares issued under the Plan may be authorized and unissued shares or shares held by
the Company in its treasury, or both.
Stock-Based Award
means a grant by the Company under the Plan of an equity award or an equity based award which is not an Option or a Stock Grant, which
the Committee may, in its sole discretion, structure to qualify in whole or in part as "performance-based compensation" under Section 162(m) of the Code.
Stock Grant
means a grant by the Company of Shares under the Plan, which the Committee may, in its sole discretion, structure to qualify in whole or in
part as "performance-based compensation" under Section 162(m) of the Code.
Stock Right
means a right to Shares or the value of Shares of the Company granted pursuant to the Planan ISO, a Non-Qualified Option, a
Stock Grant or a Stock-Based Award.
Survivor
means a deceased Participant's legal representatives and/or any person or persons who acquired the Participant's rights to a Stock Right by
will or by the laws of descent and distribution.
-
2.
-
PURPOSES
OF THE PLAN
.
The
Plan is intended to encourage ownership of Shares by Employees and directors of and certain Consultants to the Company and its Affiliates in order to attract and retain such people,
to induce them to work for the benefit of the Company or of an Affiliate and to provide additional incentive for them to promote the success of the Company or of an Affiliate. The Plan provides for
the granting of ISOs, Non-Qualified Options, Stock Grants and Stock-Based Awards.
-
3.
-
SHARES
SUBJECT TO THE PLAN
.
(a) The
number of Shares which may be issued from time to time pursuant to this Plan shall be the sum of: (i) 48,741,000 shares of Common Stock or the equivalent of
such number of Shares after the Administrator, in its sole discretion, has interpreted the effect of any stock split, stock dividend, combination, recapitalization or similar transaction in accordance
with Paragraph 25 of this Plan and (ii) any shares of Common Stock that are represented by awards granted under the Company's 2006 Amended and Restated Stock Plan that are forfeited,
expire or are cancelled without delivery of shares of Common Stock or which result in the forfeiture of shares of Common Stock back to the Company on or after the date of adoption of the Plan;
provided, however, that no more than 8,995,000 Shares shall be added to the Plan pursuant to this subsection (ii).
(b) If
an Option ceases to be outstanding, in whole or in part (other than by exercise), or if the Company shall reacquire (at not more than its original issuance price) any
Shares issued pursuant to a Stock Grant or Stock-Based Award, or if any Stock Right expires or is forfeited, cancelled, or otherwise terminated or results in any Shares not being issued, the unissued
or reacquired Shares which were subject to such Stock Right shall again be available for issuance from time to time pursuant to this Plan. Notwithstanding the foregoing, if a Stock Right is exercised,
in whole or in part, by tender of
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Shares
or if the Company or an Affiliate's tax withholding obligation is satisfied by withholding Shares, the number of Shares deemed to have been issued under the Plan for purposes of the limitation
set forth in Paragraph 3(a) above shall be the number of Shares that were subject to the Stock Right or portion thereof, and not the net number of Shares actually issued. However, in the case
of ISOs, the foregoing provisions shall be subject to any limitations under the Code.
-
4.
-
ADMINISTRATION
OF THE PLAN.
The
Administrator of the Plan will be the Board of Directors, except to the extent the Board of Directors delegates its authority to the Committee, in which case the Committee shall be
the Administrator. Notwithstanding the foregoing, the Board of Directors may not take any action that would cause any outstanding Stock Right that would otherwise qualify as performance-based
compensation under Section 162(m) of the Code to fail to so qualify.
Subject
to the provisions of the Plan, the Administrator is authorized to:
-
a.
-
Interpret
the provisions of the Plan and all Stock Rights and to make all rules and determinations which it deems necessary or advisable for the
administration of the Plan;
-
b.
-
Determine
which Employees, directors and Consultants shall be granted Stock Rights;
-
c.
-
Determine
the number of Shares for which a Stock Right or Stock Rights shall be granted; provided, however, that in no event shall Stock Rights with respect
to more than 20,000,000 Shares be granted to any Participant in any fiscal year;
-
d.
-
Specify
the terms and conditions upon which a Stock Right or Stock Rights may be granted;
-
e.
-
Determine
Performance Goals no later than such time as required to ensure that a Performance-Based Award which is intended to comply with the requirements of
Section 162(m) of the Code so complies;
-
f.
-
Amend
any term or condition of any outstanding Stock Right, other than reducing the exercise price or purchase price, provided that (i) such term or
condition as amended is not prohibited by the Plan; (ii) any such amendment shall not impair the rights of a Participant under any Stock Right previously granted without such Participant's
consent or in the event of death of the Participant the Participant's Survivors; and (iii) any such amendment shall be made only after the Administrator determines whether such amendment would
cause any adverse tax consequences to the Participant, including, but not limited to, the annual vesting limitation contained in Section 422(d) of the Code and described in
Paragraph 6(b)(iv) below with respect to ISOs and pursuant to Section 409A of the Code;
-
g.
-
Make
any adjustments in the Performance Goals included in any Performance-Based Awards provided that such adjustments comply with the requirements of
Section 162(m) of the Code; and
-
h.
-
Adopt
any sub-plans applicable to residents of any specified jurisdiction as it deems necessary or appropriate in order to comply with or take advantage of
any tax or other laws applicable to the Company, any Affiliate or to Participants or to otherwise facilitate the administration of the Plan, which sub-plans may include additional restrictions or
conditions applicable to Stock Rights or Shares issuable pursuant to a Stock Right;
provided,
however, that all such interpretations, rules, determinations, terms and conditions shall be made and prescribed in the context of not causing any adverse tax consequences
under Section 409A of the Code and preserving the tax status under Section 422 of the Code of those Options which are designated as ISOs and in accordance with Section 162(m) of
the Code for all other Stock Rights to which the Committee has determined Section 162(m) is applicable. Subject to the
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foregoing,
the interpretation and construction by the Administrator of any provisions of the Plan or of any Stock Right granted under it shall be final, unless otherwise determined by the Board of
Directors, if the Administrator is the Committee. In addition, if the Administrator is the Committee, the Board of Directors may take any action under the Plan that would otherwise be the
responsibility of the Committee.
To
the extent permitted under applicable law, the Board of Directors or the Committee may allocate all or any portion of its responsibilities and powers to any one or more of its members
and may delegate all or any portion of its responsibilities and powers to any other person selected by it. The Board of
Directors or the Committee may revoke any such allocation or delegation at any time. Notwithstanding the foregoing, only the Board of Directors or the Committee shall be authorized to grant a Stock
Right to any director of the Company or to any "officer" of the Company as defined by Rule 16a-1 under the Exchange Act.
-
5.
-
ELIGIBILITY
FOR PARTICIPATION.
The
Administrator will, in its sole discretion, name the Participants in the Plan, provided, however, that each Participant must be an Employee, director or Consultant of the Company or
of an Affiliate at the time a Stock Right is granted. Notwithstanding the foregoing, the Administrator may authorize the grant of a Stock Right to a person not then an Employee, director or Consultant
of the Company or of an Affiliate; provided, however, that the actual grant of such Stock Right shall be conditioned upon such person becoming eligible to become a Participant at or prior to the time
of the execution of the Agreement evidencing such Stock Right. ISOs may be granted only to Employees who are deemed to be residents of the United States for tax purposes. Non-Qualified Options, Stock
Grants and Stock-Based Awards may be granted to any Employee, director or Consultant of the Company or an Affiliate. The granting of any Stock Right to any individual shall neither entitle that
individual to, nor disqualify him or her from, participation in any other grant of Stock Rights or any grant under any other benefit plan established by the Company or any Affiliate for Employees,
directors or Consultants.
-
6.
-
TERMS
AND CONDITIONS OF OPTIONS.
Each
Option shall be set forth in writing in an Option Agreement, duly executed by the Company and, to the extent required by law or requested by the Company, by the Participant. The
Administrator may provide that Options be granted subject to such terms and conditions, consistent with the terms and conditions specifically required under this Plan, as the Administrator may deem
appropriate including, without limitation, subsequent approval by the shareholders of the Company of this Plan or any amendments thereto. The Option Agreements shall be subject to at least the
following terms and conditions:
-
A.
-
Non-Qualified Options
: Each Option intended to be a Non-Qualified Option shall be subject to the
terms and conditions which the Administrator determines to be appropriate and in the best interest of the Company, subject to the following minimum standards for any such Non-Qualified
Option:
-
a.
-
Exercise Price
: Each Option Agreement shall state the exercise price (per share) of the Shares
covered by each Option, which exercise price shall be determined by the Administrator and shall be at least equal to the Fair Market Value per share of Common Stock on the date of the grant of the
Option.
-
b.
-
Number of Shares
: Each Option Agreement shall state the number of Shares to which it pertains.
-
c.
-
Vesting
: Each Option Agreement shall state the date or dates on which it first is exercisable
and the date after which it may no longer be exercised, and may provide that
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-
B.
-
ISOs
: Each Option intended to be an ISO shall be issued only to an Employee who is deemed to be
a resident of the United States for tax purposes, and shall be subject to the following terms and conditions, with such additional restrictions or changes as the Administrator determines are
appropriate but not in conflict with Section 422 of the Code and relevant regulations and rulings of the Internal Revenue Service:
-
a.
-
Minimum standards
: The ISO shall meet the minimum standards required of Non-Qualified Options,
as described in Paragraph 6(A) above, except clause (a) and (e) thereunder.
-
b.
-
Exercise Price
: Immediately before the ISO is granted, if the Participant owns, directly or by
reason of the applicable attribution rules in Section 424(d) of the Code:
-
i.
-
Ten
percent (10%)
or less
of the total combined voting power of all classes of stock of the Company or an
Affiliate, the exercise price per share of the Shares covered by each ISO shall not be less than the Fair Market Value per share of the Common Stock on the date of grant of the Option; or
-
ii.
-
More
than ten percent (10%) of the total combined voting power of all classes of stock of the Company or an Affiliate, the exercise price per share of the
Shares covered by each ISO shall not be less than 110% of the Fair Market Value per share of the Common Stock on the date of grant of the Option.
-
c.
-
Term of Option
: For Participants who own:
-
i.
-
Ten
percent (10%)
or less
of the total combined voting power of all classes of stock of the Company or an
Affiliate, each ISO shall terminate not more than ten (10) years from the date of the grant or at such earlier time as the Option Agreement may provide; or
-
ii.
-
More
than ten percent (10%) of the total combined voting power of all classes of stock of the Company or an Affiliate, each ISO shall terminate not more
than five (5) years from the date of the grant or at such earlier time as the Option Agreement may provide.
-
d.
-
Limitation on Yearly Exercise
: The Option Agreements shall restrict the amount of ISOs which may
become exercisable in any calendar year (under this or any other ISO plan of the Company or an Affiliate) so that the aggregate Fair Market Value (determined on the
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-
7.
-
TERMS
AND CONDITIONS OF STOCK GRANTS.
Each
Stock Grant to a Participant shall state the principal terms in an Agreement, duly executed by the Company and, to the extent required by law or requested by the Company, by the
Participant. The Agreement shall be in a form approved by the Administrator and shall contain terms and conditions which the Administrator determines to be appropriate and in the best interest of the
Company, subject to the following minimum standards:
-
(a)
-
Each
Agreement shall state the purchase price (per share), if any, of the Shares covered by each Stock Grant, which purchase price shall be determined by
the Administrator but shall not be less than the minimum consideration required by the Delaware General Corporation Law, if any, on the date of the grant of the Stock Grant;
-
(b)
-
Each
Agreement shall state the number of Shares to which the Stock Grant pertains; and
-
(c)
-
Each
Agreement shall include the terms of any right of the Company to restrict or reacquire the Shares subject to the Stock Grant, including the time period
or attainment of Performance Goals or such other performance criteria upon which such rights shall accrue and the purchase price therefor, if any.
-
8.
-
TERMS
AND CONDITIONS OF OTHER STOCK-BASED AWARDS.
The
Administrator shall have the right to grant other Stock-Based Awards based upon the Common Stock having such terms and conditions as the Administrator may determine, including,
without limitation, the grant of Shares based upon certain conditions, the grant of securities convertible into Shares and the grant of stock appreciation rights, phantom stock awards or stock units.
The principal terms of each Stock-Based Award shall be set forth in an Agreement, duly executed by the Company and, to the extent required by law or requested by the Company, by the Participant. The
Agreement shall be in a form approved by the Administrator and shall contain terms and conditions which the Administrator determines to be appropriate and in the best interest of the Company. Each
Agreement shall include the terms of any right of the Company including the right to terminate the Stock-Based Award without the issuance of Shares, the terms of any vesting conditions, Performance
Goals or events upon which Shares shall be issued. Under no circumstances may the Agreement covering stock appreciation rights (a) have an exercise price (per share) that is less than the Fair
Market Value per share of Common Stock on the date of grant or (b) expire more than ten years following the date of grant.
The
Company intends that the Plan and any Stock-Based Awards granted hereunder be exempt from the application of Section 409A of the Code or meet the requirements of
paragraphs (2), (3) and (4) of subsection (a) of Section 409A of the Code, to the extent applicable, and be operated in accordance with Section 409A so that
any compensation deferred under any Stock-Based Award (and applicable investment earnings) shall not be included in income under Section 409A of the Code. Any ambiguities in the Plan shall be
construed to effect the intent as described in this Paragraph 8.
-
9.
-
PERFORMANCE-BASED
AWARDS.
Notwithstanding
anything to the contrary herein, during any period when Section 162(m) of the Code is applicable to the Company and the Plan, Stock Rights granted under
Paragraph 7 and Paragraph 8 may be granted by the Committee in a manner which is deductible by the Company under Section 162(m) of the Code ("Performance-Based Awards"). A
Participant's Performance-Based Award shall be determined based on the attainment of written Performance Goals, which must be objective
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and
approved by the Committee for a performance period of between one and five years established by the Committee (I) while the outcome for that performance period is substantially uncertain
and (II) no more than 90 days after the commencement of the performance period to which the Performance Goal relates or, if less, the number of days which is equal to 25% of the relevant
performance period. The Committee shall determine whether, with respect to a performance period, the applicable Performance Goals have been met with respect to a given Participant and, if they have,
to so certify and ascertain the amount of the applicable Performance-Based Award. No Performance-Based Awards will be issued for such performance period until such certification is made by the
Committee. The number of shares issued in respect of a Performance-Based Award to a given Participant may be less than the amount determined by the applicable Performance Goal formula, at the
discretion of the Committee. The number of shares issued in respect of a Performance-Based Award determined by the Committee for a performance period shall be paid to the Participant at such time as
determined by the Committee in its sole discretion after the end of such performance period. Nothing in this Section shall prohibit the Company from granting Stock-Based Awards subject to performance
criteria that do not comply with this Paragraph.
-
10.
-
EXERCISE
OF OPTIONS AND ISSUE OF SHARES.
An
Option (or any part or installment thereof) shall be exercised by giving written notice to the Company or its designee (in a form acceptable to the Administrator, which may include
electronic notice), together with provision for payment of the aggregate exercise price in accordance with this Paragraph for the Shares as to which the Option is being exercised, and upon compliance
with any other condition(s) set forth in the Option Agreement. Such notice shall be signed by the person exercising the Option (which signature may be provided electronically in a form acceptable to
the Administrator), shall state the number of Shares with respect to which the Option is being exercised and shall contain any representation required by the Plan or the Option Agreement. Payment of
the exercise price for the Shares as to which such Option is being exercised shall be made (a) in United States dollars in cash or by check; or (b) at the discretion of the
Administrator, through delivery of shares of Common Stock held for at least six months (if required to avoid negative accounting
treatment) having a Fair Market Value equal as of the date of the exercise to the aggregate cash exercise price for the number of Shares as to which the Option is being exercised; or (c) at the
discretion of the Administrator, by having the Company retain from the Shares otherwise issuable upon exercise of the Option, a number of Shares having a Fair Market Value equal as of the date of
exercise to the aggregate exercise price for the number of Shares as to which the Option is being exercised; or (d) at the discretion of the Administrator, in accordance with a cashless
exercise program established with a securities brokerage firm, and approved by the Administrator; or (e) at the discretion of the Administrator, by any combination of (a), (b), (c) and
(d) above or (f) at the discretion of the Administrator, by payment of such other lawful consideration as the Administrator may determine. Notwithstanding the foregoing, the
Administrator shall accept only such payment on exercise of an ISO as is permitted by Section 422 of the Code.
The
Company shall then reasonably promptly deliver the Shares as to which such Option was exercised to the Participant (or to the Participant's Survivors, as the case may be). In
determining what constitutes "reasonably promptly," it is expressly understood that the issuance and delivery of the Shares may be delayed by the Company in order to comply with any law or regulation
(including, without limitation, state securities or "blue sky" laws) which requires the Company to take any action with respect to the Shares prior to their issuance. The Shares shall, upon delivery,
be fully paid, non-assessable Shares.
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-
11.
-
ACCEPTANCE
OF STOCK GRANTS AND STOCK-BASED AWARDS AND ISSUE OF SHARES.
Any Stock Grant or Stock-Based Award requiring payment of a purchase price for the Shares as to which such Stock Grant or Stock-Based Award is being granted shall
be made (a) in United States dollars in cash or by check; or (b) at the discretion of the Administrator, through delivery of shares of Common Stock held for at least six months (if
required to avoid negative accounting treatment) and having a Fair Market Value equal as of the date of payment to the purchase price of the Stock Grant or Stock-Based Award; or (c) at the
discretion of the Administrator, by any combination of (a) and (b) above; or (d) at the discretion of the Administrator, by payment of such other lawful consideration as the
Administrator may determine.
The
Company shall when required by the applicable Agreement, reasonably promptly deliver the Shares as to which such Stock Grant or Stock-Based Award was made to the Participant (or to
the
Participant's Survivors, as the case may be), subject to any escrow provision set forth in the applicable Agreement. In determining what constitutes "reasonably promptly," it is expressly understood
that the issuance and delivery of the Shares may be delayed by the Company in order to comply with any law or regulation (including, without limitation, state securities or "blue sky" laws) which
requires the Company to take any action with respect to the Shares prior to their issuance.
-
12.
-
RIGHTS
AS A SHAREHOLDER.
No
Participant to whom a Stock Right has been granted shall have rights as a shareholder with respect to any Shares covered by such Stock Right, except after due exercise of an Option or
issuance of Shares as set forth in any Agreement, tender of the aggregate exercise or purchase price, if any, for the Shares being purchased and registration of the Shares in the Company's share
register in the name of the Participant.
-
13.
-
ASSIGNABILITY
AND TRANSFERABILITY OF STOCK RIGHTS.
By
its terms, a Stock Right granted to a Participant shall not be transferable by the Participant other than (i) by will or by the laws of descent and distribution, or
(ii) as approved by the Administrator in its discretion and set forth in the applicable Agreement provided that no Stock Right may be transferred by a Participant for value. Notwithstanding the
foregoing, an ISO transferred except in compliance with clause (i) above shall no longer qualify as an ISO. The designation of a beneficiary of a Stock Right by a Participant, with the prior
approval of the Administrator and in such form as the Administrator shall prescribe, shall not be deemed a transfer prohibited by this Paragraph. Except as provided above, during the Participant's
lifetime a Stock Right shall only be exercisable by or issued to such Participant (or his or her legal representative) and shall not be assigned, pledged or hypothecated in any way (whether by
operation of law or otherwise) and shall not be subject to execution, attachment or similar process. Any attempted transfer, assignment, pledge, hypothecation or other disposition of any Stock Right
or of any rights granted thereunder contrary to the provisions of this Plan, or the levy of any attachment or similar process upon a Stock Right, shall be null and void.
-
14.
-
EFFECT
ON OPTIONS OF TERMINATION OF SERVICE OTHER THAN FOR CAUSE OR DEATH OR DISABILITY
.
Except
as otherwise provided in a Participant's Option Agreement in the event of a termination of service (whether as an Employee, director or Consultant) with the Company or an
Affiliate before the Participant has exercised an Option, the following rules apply:
-
a.
-
A
Participant who ceases to be an Employee, director or Consultant of the Company or of an Affiliate (for any reason other than termination for Cause,
Disability, or death for which events there are special rules in Paragraphs 15, 16, and 17, respectively), may exercise any
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-
15.
-
EFFECT
ON OPTIONS OF TERMINATION OF SERVICE FOR CAUSE
.
Except
as otherwise provided in a Participant's Option Agreement, the following rules apply if the Participant's service (whether as an Employee, director or Consultant) with the Company
or an Affiliate is terminated for Cause prior to the time that all his or her outstanding Options have been exercised:
-
a.
-
All
outstanding and unexercised Options as of the time the Participant is notified his or her service is terminated for Cause will immediately be forfeited.
-
b.
-
Cause
is not limited to events which have occurred prior to a Participant's termination of service, nor is it necessary that the Administrator's finding of
Cause occur prior to termination. If the Administrator determines, subsequent to a Participant's termination of service but prior to the exercise of an Option, that either prior or subsequent to the
Participant's termination the Participant engaged in conduct which would constitute Cause, then the right to exercise any Option is forfeited.
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-
16.
-
EFFECT
ON OPTIONS OF TERMINATION OF SERVICE FOR DISABILITY
.
Except
as otherwise provided in a Participant's Option Agreement:
-
a.
-
A
Participant who ceases to be an Employee, director or Consultant of the Company or of an Affiliate by reason of Disability may exercise any Option granted
to such Participant to the extent that the Option has become exercisable but has not been exercised on the date of the Participant's termination of service due to Disability;
-
b.
-
In
the event rights to exercise the Option accrue periodically, to the extent of a pro rata portion through the date of the Participant's termination of
service due to Disability of any additional vesting rights that would have accrued on the next vesting date had the Participant not become Disabled. The proration shall be based upon the number of
days accrued in the current vesting period prior to the date of the Participant's termination of service due to Disability;
-
c.
-
A
Disabled Participant may exercise the Option only within the period ending one year after the date of the Participant's termination of service due to
Disability, notwithstanding that the Participant might have been able to exercise the Option as to some or all of the Shares on a later date if the Participant had not been terminated due to
Disability and had continued to be an Employee, director or Consultant or, if earlier, within the originally prescribed term of the Option; and
-
d.
-
The
Administrator shall make the determination both of whether Disability has occurred and the date of its occurrence (unless a procedure for such
determination is set forth in another agreement between the Company and such Participant, in which case such procedure shall be used for such determination). If requested, the Participant shall be
examined by a physician selected or approved by the Administrator, the cost of which examination shall be paid for by the Company.
-
17.
-
EFFECT
ON OPTIONS OF DEATH WHILE AN EMPLOYEE, DIRECTOR OR CONSULTANT
.
Except
as otherwise provided in a Participant's Option Agreement:
-
a.
-
In
the event of the death of a Participant while the Participant is an Employee, director or Consultant of the Company or of an Affiliate, such Option may be
exercised by the Participant's Survivors to the extent that the Option has become exercisable but has not been exercised on the date of death;
-
b.
-
In
the event rights to exercise the Option accrue periodically, to the extent of a pro rata portion through the date of death of any additional vesting
rights that would have accrued on the next vesting date had the Participant not died. The proration shall be based upon the number of days accrued in the current vesting period prior to the
Participant's date of death; and
-
c.
-
If
the Participant's Survivors wish to exercise the Option, they must take all necessary steps to exercise the Option within one year after the date of death
of such Participant, notwithstanding that the decedent might have been able to exercise the Option as to some or all of the Shares on a later date if he or she had not died and had continued to be an
Employee, director or Consultant or, if earlier, within the originally prescribed term of the Option.
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-
18.
-
EFFECT
OF TERMINATION OF SERVICE ON STOCK GRANTS AND STOCK-BASED AWARDS
.
In
the event of a termination of service (whether as an Employee, director or Consultant) with the Company or an Affiliate for any reason before the Participant has accepted a Stock
Grant, or Stock-Based Award and paid the purchase price, if required, such grant shall terminate.
For
purposes of this Paragraph 18 and Paragraph 19 below, a Participant to whom a Stock Grant or a Stock-Based Award has been issued under the Plan who is absent from work
with the Company or with an Affiliate because of temporary disability (any disability other than a Disability as defined in Paragraph 1 hereof), or who is on leave of absence for any purpose,
shall not, during the period of any such absence, be deemed, by virtue of such absence alone, to have terminated such Participant's employment, director status or consultancy with the Company or with
an Affiliate, except as the Administrator may otherwise expressly provide.
In
addition, for purposes of this Paragraph 18 and Paragraph 19 below, any change of employment or other service within or among the Company and any Affiliates shall not be
treated as a termination of employment, director status or consultancy so long as the Participant continues to be an Employee, director or Consultant of the Company or any Affiliate.
-
19.
-
EFFECT
ON STOCK GRANTS AND STOCK-BASED AWARDS OF TERMINATION OF SERVICE OTHER THAN FOR CAUSE, DEATH OR DISABILITY
.
Except
as otherwise provided in a Participant's Agreement, in the event of a termination of service for any reason (whether as an Employee, director or Consultant), other than
termination for Cause, death or Disability for which there are special rules in Paragraphs 20, 21, and 22 below, before all forfeiture provisions or Company rights of repurchase shall have
lapsed, then the Company shall have the right to cancel or repurchase that number of Shares subject to a Stock Grant or Stock-Based Award as to which the Company's forfeiture or repurchase rights have
not lapsed.
-
20.
-
EFFECT
ON STOCK GRANTS AND STOCK-BASED AWARDS OF TERMINATION OF SERVICE "FOR CAUSE"
.
Except
as otherwise provided in a Participant's Agreement, the following rules apply if the Participant's service (whether as an Employee, director or Consultant) with the Company or an
Affiliate is terminated for Cause:
-
a.
-
All
Shares subject to any Stock Grant or Stock-Based Award that remain subject to forfeiture provisions or as to which the Company shall have a repurchase
right shall be immediately forfeited to the Company as of the time the Participant is notified his or her service is terminated for Cause.
-
b.
-
Cause
is not limited to events which have occurred prior to a Participant's termination of service, nor is it necessary that the Administrator's finding of
Cause occur prior to termination. If the Administrator determines, subsequent to a Participant's termination of service, that either prior or subsequent to the Participant's termination the
Participant engaged in conduct which would constitute Cause, then all Shares subject to any Stock Grant or Stock-Based Award that remained subject to forfeiture provisions or as to which the Company
had a repurchase right on the date of termination shall be immediately forfeited to the Company.
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Table of Contents
-
21.
-
EFFECT
ON STOCK GRANTS AND STOCK-BASED AWARDS OF TERMINATION OF SERVICE FOR DISABILITY
.
Except as otherwise provided in a Participant's Agreement, the following rules apply if a Participant ceases to be an Employee, director or Consultant of the
Company or of an Affiliate by reason of Disability: to the extent the forfeiture provisions or the Company's rights of repurchase have not lapsed on the date of Disability, they shall be exercisable;
provided, however, that in the event such forfeiture provisions or rights of repurchase lapse periodically, such provisions or rights shall lapse to the extent of a pro rata portion of the Shares
subject to such Stock Grant or Stock-Based Award through the date of Disability as would have lapsed had the Participant not become Disabled. The proration shall be based upon the number of days
accrued prior to the date of Disability.
The
Administrator shall make the determination both as to whether Disability has occurred and the date of its occurrence (unless a procedure for such determination is set forth in
another agreement
between the Company and such Participant, in which case such procedure shall be used for such determination). If requested, the Participant shall be examined by a physician selected or approved by the
Administrator, the cost of which examination shall be paid for by the Company.
-
22.
-
EFFECT
ON STOCK GRANTS AND STOCK-BASED AWARDS OF DEATH WHILE AN EMPLOYEE, DIRECTOR OR CONSULTANT
.
Except
as otherwise provided in a Participant's Agreement, the following rules apply in the event of the death of a Participant while the Participant is an Employee, director or
Consultant of the Company or of an Affiliate: to the extent the forfeiture provisions or the Company's rights of repurchase have not lapsed on the date of death, they shall be exercisable; provided,
however, that in the event such forfeiture provisions or rights of repurchase lapse periodically, such provisions or rights shall lapse to the extent of a pro rata portion of the Shares subject to
such Stock Grant or Stock-Based Award through the date of death as would have lapsed had the Participant not died. The proration shall be based upon the number of days accrued prior to the
Participant's date of death.
-
23.
-
PURCHASE
FOR INVESTMENT
.
Unless
the offering and sale of the Shares shall have been effectively registered under the Securities Act, the Company shall be under no obligation to issue Shares under the Plan unless
and until the following conditions have been fulfilled:
-
a.
-
The
person who receives a Stock Right shall warrant to the Company, prior to the receipt of Shares, that such person is acquiring such Shares for his or her
own account, for investment, and not with a view to, or for sale in connection with, the distribution of any such Shares, in which event the person acquiring such Shares shall be bound by the
provisions of the following legend (or a legend in substantially similar form) which shall be endorsed upon the certificate evidencing the Shares issued pursuant to such exercise or such grant:
"The
shares represented by this certificate have been taken for investment and they may not be sold or otherwise transferred by any person, including a pledgee, unless (1) either (a) a
Registration Statement with respect to such shares shall be effective under the Securities Act of 1933, as amended, or (b) the Company shall have received an opinion of counsel satisfactory to
it that an exemption from
registration under such Act is then available, and (2) there shall have been compliance with all applicable state securities laws."
-
b.
-
At
the discretion of the Administrator, the Company shall have received an opinion of its counsel that the Shares may be issued in compliance with the
Securities Act without registration thereunder.
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Table of Contents
-
24.
-
DISSOLUTION
OR LIQUIDATION OF THE COMPANY
.
Upon
the dissolution or liquidation of the Company, all Options granted under this Plan which as of such date shall not have been exercised and all Stock Grants and Stock-Based Awards
which have not been accepted, to the extent required under the applicable Agreement, will terminate and become null and void; provided, however, that if the rights of a Participant or a Participant's
Survivors have not otherwise terminated and expired, the Participant or the Participant's Survivors will have the right immediately prior to such dissolution or liquidation to exercise or accept any
Stock Right to the extent that the Stock Right is exercisable or subject to acceptance as of the date immediately prior to such dissolution or liquidation. Upon the dissolution or liquidation of the
Company, any outstanding Stock-Based Awards shall immediately terminate unless otherwise determined by the Administrator or specifically provided in the applicable Agreement.
-
25.
-
ADJUSTMENTS
.
Upon
the occurrence of any of the following events, a Participant's rights with respect to any Stock Right granted to him or her hereunder shall be adjusted as hereinafter provided,
unless otherwise specifically provided in a Participant's Agreement:
A.
Stock Dividends and Stock Splits.
If (i) the shares of Common Stock shall be subdivided or combined
into a greater or smaller number of shares or if the Company shall issue any shares of
Common Stock as a stock dividend on its outstanding Common Stock, or (ii) additional shares or new or different shares or other securities of the Company or other non-cash assets are
distributed with respect to such shares of Common Stock, each Stock Right and the number of shares of Common Stock deliverable thereunder shall be appropriately increased or decreased proportionately,
and appropriate adjustments shall be made including, in the exercise or purchase price per share to reflect such events. The number of Shares subject to the limitations in Paragraphs 3(a) and
4(c) shall also be proportionately adjusted upon the occurrence of such events and the Performance Goals applicable to outstanding Performance-Based Awards.
B.
Corporate Transactions.
If the Company is to be consolidated with or acquired by another entity in a
merger, consolidation, or sale of all or substantially all of the Company's assets
other than a transaction to merely change the state of incorporation (a "Corporate Transaction"), the Administrator or the board of directors of any entity assuming the obligations of the Company
hereunder (the "Successor Board"), shall, as to outstanding Options, either (i) make appropriate provision for the continuation of such Options by substituting on an equitable basis for the
Shares then subject to such Options either the consideration payable with respect to the outstanding shares of Common Stock in connection with the Corporate Transaction or securities of any successor
or acquiring entity; or (ii) upon written notice to the Participants, provide that such Options must be exercised within a specified number of days of the date of such notice, at the end of
which period such Options which have not yet been exercised shall terminate (all Options shall for purposes of this clause (ii) be made fully vested and exercisable immediately prior to their
termination); or (iii) terminate such Options in exchange for payment of an amount equal to the consideration payable upon consummation of such Corporate Transaction to a holder of the number
of shares of Common Stock into which such Option would have been exercisable (all Options shall for purposes of this clause (iii) be made fully vested and immediately exercisable immediately
prior to their termination)
less the aggregate
exercise price thereof. For purposes of determining the payments to be made pursuant to
Subclause (iii) above, in the case of a Corporate Transaction the consideration for which, in whole or in part, is other than cash, the consideration other than cash shall be valued at the fair
value thereof as determined in good faith by the Board of Directors.
With
respect to outstanding Stock Grants, the Administrator or the Successor Board, shall either (i) make appropriate provision for the continuation of such Stock Grants on the
same terms and
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conditions
by substituting on an equitable basis for the Shares then subject to such Stock Grants the securities of any successor or acquiring entity in the Corporate Transaction or (ii)provide that,
upon consummation of the Corporate Transaction, each outstanding Stock Grant shall be terminated in exchange for payment of an amount equal to the consideration payable upon consummation of such
Corporate Transaction to a holder of the number of shares of Common Stock comprising such Stock Grant (all forfeiture and repurchase rights being waived upon such Corporate Transaction).
In
taking any of the actions permitted under this Paragraph 25(B), the Administrator shall not be obligated by the Plan to treat all Stock Rights, all Stock Rights held by a
Participant, or all Stock Rights of the same type, identically.
C.
Recapitalization or Reorganization.
In the event of a recapitalization or reorganization of the Company,
other than a Corporate Transaction, pursuant to which securities of the Company or of another
corporation are issued with respect to the outstanding shares of Common Stock, a Participant upon exercising an Option or accepting a Stock Grant after the recapitalization or reorganization shall be
entitled to receive for the price paid upon such exercise or acceptance, if any, the number of replacement securities which would have been received if such Option had been exercised or Stock Grant
accepted prior to such recapitalization or reorganization.
D.
Adjustments to Stock-Based Awards.
Upon the happening of any of the events described in
Subparagraphs A, B or C above, any outstanding Stock-Based Award shall be appropriately adjusted to
reflect the events described in such Subparagraphs. The Administrator or the Successor Board shall determine the specific adjustments to be made under this Paragraph 25, including, but not
limited to the effect of any Corporate Transaction and Change of Control and, subject to Paragraph 4, its determination shall be conclusive.
E.
Modification of Options.
Notwithstanding the foregoing, any adjustments made pursuant to
Subparagraph A, B or C above with respect to Options shall be made only after the
Administrator determines whether such adjustments would (i) constitute a "modification" of any ISOs (as that term is defined in Section 424(h) of the Code) or (ii) cause any
adverse tax consequences for the holders of Options, including, but not limited to, pursuant to Section 409A of the Code. If the Administrator determines that such adjustments made with respect
to Options would constitute a modification or other adverse tax consequence, it may refrain from making such adjustments, unless the holder of an Option specifically agrees in writing that such
adjustment be made and such writing indicates that the holder has full knowledge of the consequences of such "modification" on his or her income tax treatment with respect to the Option. This
paragraph shall not apply to the acceleration of the vesting of any ISO that would cause any portion of the ISO to violate the annual vesting limitation contained in Section 422(d) of the Code,
as described in Paragraph 6(B)(d).
F.
Modification of Performance-Based Awards.
Notwithstanding the foregoing, with respect to any
Performance-Based Award that is intended to comply as "performance based compensation" under
Section 162(m) of the Code, the Committee may adjust downwards, but not upwards, the number of Shares payable pursuant to a Performance-Based Award, and the Committee may not waive the
achievement of the applicable Performance Goals except in the case of death or disability of the Participant.
G.
Change of Control.
In the event of either
(A) a
Corporate Transaction that also constitutes a Change of Control, where outstanding Options are assumed or substituted in accordance with the first paragraph of
Subparagraph B clause (i) above and, with respect to Stock Grants, in accordance with the second paragraph of Subparagraph B clause (i); or
(B) a
Change of Control that does not also constitute a Corporate Transaction,
D-16
Table of Contents
if
within six months after the date of such Change of Control, (i) a Participant's service is terminated by the Company or an Affiliate for any reason other than Cause; or (ii) a
Participant terminates his or her service as a result of being required to change the principal location where he or she renders services to a location more than 50 miles from his or her location of
employment or consultancy immediately prior to the Change of Control; or (iii) the Participant terminates his or her service after there occurs a material adverse change in a Participant's
duties, authority or responsibilities which causes such Participant's position with the Company to become of significantly less responsibility or authority than such Participant's position was
immediately prior to the Change of Control,
then
all of such Participant's (i) Options outstanding under the Plan shall become fully vested and immediately exercisable as of
the date of termination of such Participant, unless in any such case the Option has otherwise expired or been terminated pursuant to its terms or the terms of the Plan and (ii) any forfeiture
or repurchase rights of the Company with respect to outstanding Stock Grants that have not lapsed or expired prior to such Change of Control shall terminate as of the date of termination of such
Participant.
-
26.
-
ISSUANCES
OF SECURITIES
.
Except
as expressly provided herein, no issuance by the Company of shares of stock of any class, or securities convertible into shares of stock of any class, shall affect, and no
adjustment by reason thereof shall be made with respect to, the number or price of shares subject to Stock Rights. Except as expressly provided herein, no adjustments shall be made for dividends paid
in cash or in property (including without limitation, securities) of the Company prior to any issuance of Shares pursuant to a Stock Right.
-
27.
-
FRACTIONAL
SHARES
.
No
fractional shares shall be issued under the Plan and the person exercising a Stock Right shall receive from the Company cash in lieu of such fractional shares equal to the Fair Market
Value thereof.
-
28.
-
CONVERSION
OF ISOs INTO NON-QUALIFIED OPTIONS; TERMINATION OF ISOs
.
The
Administrator, at the written request of any Participant, may in its discretion take such actions as may be necessary to convert such Participant's ISOs (or any portions thereof)
that have not been exercised on the date of conversion into Non-Qualified Options at any time prior to the expiration of such ISOs, regardless of whether the Participant is an Employee of the Company
or an Affiliate at the time of such conversion. At the time of such conversion, the Administrator (with the consent of the Participant) may impose such conditions on the exercise of the resulting
Non-Qualified Options as the Administrator in its discretion may determine, provided that such conditions shall not be inconsistent with this Plan. Nothing in the Plan shall be deemed to give any
Participant the right to have such Participant's ISOs converted into Non-Qualified Options, and no such conversion shall occur until and unless the Administrator takes appropriate action. The
Administrator, with the consent of the Participant, may also terminate any portion of any ISO that has not been exercised at the time of such conversion.
D-17
Table of Contents
-
29.
-
WITHHOLDING
.
In the event that any federal, state, or local income taxes, employment taxes, Federal Insurance Contributions Act ("F.I.C.A.") withholdings or other amounts are
required by applicable law or governmental regulation to be withheld from the Participant's salary, wages or other remuneration in connection with the issuance of a Stock Right or Shares under the
Plan or for any other reason required by law, the Company may withhold from the Participant's compensation, if any, or may require that the Participant advance in cash to the Company, or to any
Affiliate of the Company which employs or employed the Participant, the statutory minimum amount of such withholdings unless a different withholding arrangement, including the use of shares of the
Company's Common Stock or a promissory note, is authorized by the Administrator (and permitted by law). For purposes hereof, the fair market value of the shares withheld for purposes of payroll
withholding shall be determined in the manner set forth under the definition of Fair Market Value provided in Paragraph 1 above, as of the most recent practicable date prior to the date of
exercise. If the Fair Market Value of the shares withheld is less than the amount of payroll withholdings required, the Participant may be required to advance the difference in cash to the Company or
the Affiliate employer. The Administrator in its
discretion may condition the exercise of an Option for less than the then Fair Market Value on the Participant's payment of such additional withholding.
-
30.
-
NOTICE
TO COMPANY OF DISQUALIFYING DISPOSITION
.
Each
Employee who receives an ISO must agree to notify the Company in writing immediately after the Employee makes a "Disqualifying Disposition" of any Shares acquired pursuant to the
exercise of an ISO. A Disqualifying Disposition is defined in Section 424(c) of the Code and includes any disposition (including any sale or gift) of such Shares before the later of
(a) two years after the date the Employee was granted the ISO, or (b) one year after the date the Employee acquired Shares by exercising the ISO, except as otherwise provided in
Section 424(c) of the Code. If the Employee has died before such Shares are sold, these holding period requirements do not apply and no Disqualifying Disposition can occur thereafter.
-
31.
-
TERMINATION
OF THE PLAN
.
The
Plan will terminate on April 23, 2025 the date which is ten (10) years from the
earlier
of the date of its adoption by
the Board of Directors and the date of its approval by the shareholders of the Company. The Plan may be terminated at an earlier date by vote of the shareholders or the Board of Directors of the
Company; provided, however, that any such earlier termination shall not affect any Agreements executed prior to the effective date of such termination. Termination of the Plan shall not effect any
Stock Rights theretofore granted.
-
32.
-
AMENDMENT
OF THE PLAN AND AGREEMENTS
.
The
Plan may be amended by the shareholders of the Company. The Plan may also be amended by the Administrator, including, without limitation, to the extent necessary to qualify any or
all outstanding Stock Rights granted under the Plan or Stock Rights to be granted under the Plan for favorable federal income tax treatment as may be afforded incentive stock options under
Section 422 of the Code (including deferral of taxation upon exercise), and to the extent necessary to qualify the Shares issuable under the Plan for listing on any national securities exchange
or quotation in any national automated quotation system of securities dealers; and in order to continue to comply with Section 162(m) of the Code; provided that any amendment approved by the
Administrator which the Administrator determines is of a scope that requires shareholder approval shall be subject to obtaining such shareholder approval. Other than as set forth in
Paragraph 25 of the Plan, the Administrator may not
without shareholder approval reduce the exercise price of an Option or cancel any outstanding Option in exchange for a replacement option having a lower exercise price, any Stock Grant, any other
D-18
Table of Contents
Stock-Based
Award or for cash. In addition, the Administrator not take any other action that is considered a direct or indirect "repricing" for purposes of the shareholder approval rules of the
applicable securities exchange or inter-dealer quotation system on which the Shares are listed, including any other action that is treated as a repricing under generally accepted accounting
principles. Any modification or amendment of the Plan shall not, without the consent of a Participant, adversely affect his or her rights under a Stock Right previously granted to him or her. With the
consent of the Participant affected, the Administrator may amend outstanding Agreements in a manner which may be adverse to the Participant but which is not inconsistent with the Plan. In the
discretion of the Administrator, outstanding Agreements may be amended by the Administrator in a manner which is not adverse to the Participant. Nothing in this Paragraph 32 shall limit the
Administrator's authority to take any action permitted pursuant to Paragraph 25.
-
33.
-
EMPLOYMENT
OR OTHER RELATIONSHIP
.
Nothing
in this Plan or any Agreement shall be deemed to prevent the Company or an Affiliate from terminating the employment, consultancy or director status of a Participant, nor to
prevent a Participant from terminating his or her own employment, consultancy or director status or to give any Participant a right to be retained in employment or other service by the Company or any
Affiliate for any period of time.
-
34.
-
SECTION 409A
.
If
a Participant is a "specified employee" as defined in Section 409A of the Code (and as applied according to procedures of the Company and its Affiliates) as of his separation
from service, to the extent any payment under this Plan or pursuant to the grant of a Stock-Based Award constitutes deferred compensation (after taking into account any applicable exemptions from
Section 409A of the Code), and to the extent required by Section 409A of the Code, no payments due under this Plan or pursuant to a Stock-Based Award may be made until the earlier of:
(i) the first day of the seventh month following the Participant's separation from service, or (ii) the Participant's date of death; provided, however, that any payments delayed during
this six-month period shall be paid in the
aggregate in a lump sum, without interest, on the first day of the seventh month following the Participant's separation from service.
The
Administrator shall administer the Plan with a view toward ensuring that Stock Rights under the Plan that are subject to Section 409A of the Code comply with the requirements
thereof and that Options under the Plan be exempt from the requirements of Section 409A of the Code, but neither the Administrator nor any member of the Board, nor the Company nor any of its
Affiliates, nor any other person acting hereunder on behalf of the Company, the Administrator or the Board shall be liable to a Participant or any Survivor by reason of the acceleration of any income,
or the imposition of any additional tax or penalty, with respect to a Stock Right, whether by reason of a failure to satisfy the requirements of Section 409A of the Code or otherwise.
-
35.
-
INDEMNITY
.
Neither
the Board nor the Administrator, nor any members of either, nor any employees of the Company or any parent, subsidiary, or other Affiliate, shall be liable for any act, omission,
interpretation, construction or determination made in good faith in connection with their responsibilities with respect to this Plan, and the Company hereby agrees to indemnify the members of the
Board, the members of the Committee, and the employees of the Company and its parent or subsidiaries in respect of any claim, loss, damage, or expense (including reasonable counsel fees) arising from
any such act, omission, interpretation, construction or determination to the full extent permitted by law.
D-19
Table of Contents
-
36.
-
CLAWBACK
Notwithstanding
anything to the contrary contained in this Plan, the Company may recover from a Participant any compensation received from any Stock Right (whether or not settled) or
cause a Participant to forfeit any Stock Right (whether or not vested) in the event that the Company's Clawback Policy then in effect is triggered.
-
37.
-
GOVERNING
LAW
.
This
Plan shall be construed and enforced in accordance with the law of the State of Delaware.
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NNNNNNNNNNNN . NNNNNNNNNNNNNNN C123456789 000004 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext ENDORSEMENT_LINE SACKPACK Electronic Voting Instructions You can vote by Internet or telephone! Available 24 hours a day, 7 days a week! Instead of mailing your proxy, you may choose one of the two voting methods outlined below to vote your proxy. VALIDATION DETAILS ARE LOCATED BELOW IN THE TITLE BAR. Proxies submitted by the Internet or telephone must be received by 1:00 a.m., Central Time, on July 21, 2016. Vote by Internet Go to www.investorvote.com/SNTA Or scan the QR code with your smartphone Follow the steps outlined on the secure website MR A SAMPLE DESIGNATION (IF ANY) ADD 1 ADD 2 ADD 3 ADD 4 ADD 5 ADD 6 Vote by telephone Call toll free 1-800-652-VOTE (8683) within the USA, US territories & Canada on a touch tone telephone Follow the instructions provided by the recorded message Using a black ink pen, mark your votes with an X as shown in this example. Please do not write outside the designated areas. q IF YOU HAVE NOT VOTED VIA THE INTERNET OR TELEPHONE, FOLD ALONG THE PERFORATION, DETACH AND RETURN THE BOTTOM PORTION IN THE ENCLOSED ENVELOPE. q Proposals The Board of Directors recommends a vote FOR the nominee listed and FOR Proposals 1, 2, 3, 5, 6, 7 and 8. + For Against Abstain 4. Election of Director (or if nominee is not available for election, such substitute as the Board of Directors may designate). For Withhold 1. Proposal to approve the Agreement and Plan of Merger and Reorganization, dated April 13, 2016, by and among Synta, Saffron Merger Sub, Inc. and Madrigal Pharmaceuticals, Inc., and the issuance of shares of Synta common stock to Madrigal stockholders by virtue of the merger contemplated by the Merger Agreement: 2. Proposal to approve a certificate of amendment to Syntas restated certificate of incorporation to effect a reverse stock split of Syntas issued and outstanding shares of common stock, pursuant to which any whole number of outstanding shares between and including twenty (20) and thirty-five (35), such number to be determined by the Synta board of directors, would be combined and reclassified into one share of Synta common stock. 01 - Bruce Kovner ForAgainst Abstain 5. Proposal to approve, on an advisory basis, the compensation of the Companys named executive officers, as disclosed pursuant to the compensation disclosure rules of the Securities and Exchange Commission. 6. Proposal to approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to Syntas executive officers in connection with the merger identified in Proposal No. 1. 7. Proposal to ratify the election of Ernst & Young LLP as Syntas independent registered public accounting firm for the fiscal year ending December 31, 2016 . 3. Proposal to approve an amendment to the 2015 Stock Plan that would, among other things, the aggregate number of shares for which share awards may be granted under the 2015 Stock Plan by 40,000,000 shares. 8. Proposal to approve an adjournment of the 2016 Annual Meeting, if necessary, if a quorum is present, to solicit additional proxies if there are not sufficient votes in favor of Synta Proposal Nos. 1, 2 and 3. Authorized Signatures This section must be completed for your vote to be counted. Date and Sign Below Please sign exactly as name(s) appears hereon. Joint owners should each sign. When signing as attorney, executor, administrator, corporate officer, trustee, guardian, or custodian, please give full title as such. Date (mm/dd/yyyy) Please print date below. Signature 1 Please keep signature within the box. Signature 2 Please keep signature within the box. NNNNNNNC 1234567890 J N T MR A SAMPLE (THIS AREA IS SET UP TO ACCOMMODATE 140 CHARACTERS) MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND + 1 U P X2 8 4 1 0 1 1 02DVVA NNNNNNNNN B A Annual Meeting Proxy Card1234 5678 9012 345 X IMPORTANT ANNUAL MEETING INFORMATION
. q IF YOU HAVE NOT VOTED VIA THE INTERNET OR TELEPHONE, FOLD ALONG THE PERFORATION, DETACH AND RETURN THE BOTTOM PORTION IN THE ENCLOSED ENVELOPE. q + Proxy SYNTA PHARMACEUTICALS CORP. 125 HARTWELL AVENUE LEXINGTON, MA 02421 PROXY FOR ANNUAL MEETING OF STOCKHOLDERS - JULY 21, 2016 SYNTA PHARMACEUTICALS CORP. BOARD OF DIRECTORS SOLICITS THIS PROXY The undersigned, revoking any previous proxies relating to these shares, hereby acknowledges receipt of the Notice and Proxy Statement in connection with the Annual Meeting of Stockholders to be held at 9:00 a.m. ET on Friday, July 21, 2016 at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. at One Financial Center, Boston, MA 02111 and hereby appoints Chen Schor and Marc Schneebaum (with full power to act alone) the attorneys and proxies of the undersigned, with power of substitution, to vote all shares of the Common Stock of Synta Pharmaceuticals Corp. registered in the name provided in this Proxy which the undersigned is entitled to vote at the 2016 Annual Meeting of Stockholders, and at any adjournments of the meeting, with all the powers the undersigned would have if personally present at the meeting. Without limiting the general authorization given by this Proxy, the proxy is instructed to vote or act as follows on the proposals set forth in the Proxy. This Proxy, when executed, will be voted in the manner directed herein. If you do not specify below how you want your shares to be voted, this Proxy will be voted FOR the election of the Director and FOR Proposals 1, 2, 3, 5, 6, 7 and 8. In his discretion, the proxy is authorized to vote upon such other business as may properly come before the meeting. If you wish to vote in accordance with the Board of Directors recommendations, just sign on the reverse side. You need not mark any boxes. Mark, sign and date your proxy card and return it promptly in the enclosed envelope. PLEASE CAST YOUR VOTE AS SOON AS POSSIBLE! Non-Voting Items Change of Address Please print new address below. + IF VOTING BY MAIL, YOU MUST COMPLETE SECTIONS A - C ON BOTH SIDES OF THIS CARD. C