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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): November 22, 2023
MODULAR MEDICAL, INC. |
(Exact name of registrant as specified in its charter) |
Nevada |
|
001-41277 |
|
87-0620495 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
10740 Thornmint Road, San Diego, California |
|
92127 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone
number, including area code: (858) 800-3500
(Former name or former
address, if changed since last report)
Check the appropriate
box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
|
Trading symbol(s) |
|
Name of each exchange on which registered |
Common Stock |
|
MODD |
|
The Nasdaq Stock Market LLC |
Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into a Material Definitive Agreement.
On November 22,
2023, Modular Medical, Inc. (the “Company”) entered into a Sales Agreement (the “ATM Agreement”) with Leerink
Partners LLC (“Leerink”) under which the Company may offer and sell, from time to time at its sole discretion, shares of the
Company’s common stock, par value $0.001 per share (the “Common Stock”), for aggregate gross proceeds of up to $6,500,000
through an “at the market offering” program under which Leerink will act as sales agent or principal.
Under the ATM Agreement, the Company will set
the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to
be made, limitations on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be
made. Subject to the terms and conditions of the ATM Agreement, Leerink may sell the shares by methods deemed to be an “at the market
offering”, as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.
The ATM Agreement provides that Leerink will be
entitled to compensation for its services equal to 3.0% of the gross proceeds from sales of any shares of common stock under the ATM Agreement.
The Company has no obligation to sell any shares under the ATM Agreement and may, at any time, suspend solicitation and offers under the
ATM Agreement.
The shares will be issued pursuant to the Company’s
shelf registration statement on Form S-3 (File No. 333-264193). The Company filed a prospectus supplement, dated November 22, 2023
with the Securities and Exchange Commission (the “SEC”) in connection with the offer and sale of the shares pursuant to the
ATM Agreement (the “Prospectus Supplement”).
The foregoing description of the material terms
of the ATM Agreement is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this
Current Report on Form 8-K and is incorporated herein by reference.
The legal opinion of Lucosky Brookman LLP relating
to the shares of Common Stock that may be sold pursuant to ATM Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.
This Current Report on Form 8-K shall not constitute
an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or
sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such state.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
MODULAR MEDICAL, INC. |
|
|
|
Date: November 22, 2023 |
By: |
/s/ James E. Besser |
|
|
James E. Besser |
|
|
Chief Executive Officer |
Exhibit 1.1
MODULAR MEDICAL, INC.
Shares of Common Stock
($0.001 par value per share)
SALES AGREEMENT
November 22, 2023
LEERINK PARTNERS LLC
1301 Avenue of the Americas, 12th Floor
New York, New York 10019
Ladies and Gentlemen:
Modular Medical, Inc., a Nevada corporation (the
“Company”), confirms its agreement (this “Agreement”) with Leerink Partners LLC (the
“Agent”), as follows:
1. Issuance
and Sale of Shares. The Company agrees that, from time to time during the term of this Agreement, on the terms and subject to the
conditions set forth herein, it may issue and sell through or to the Agent shares of common stock, $0.001 par value per share, of the
Company (the “Common Stock”), subject to the limitations set forth in Section 5(c) (the “Placement
Shares”). Notwithstanding anything to the contrary contained herein, the parties hereto agree that compliance with the limitation
set forth in this Section 1 on the aggregate gross sales price of Placement Shares that may be issued and sold under this Agreement from
time to time shall be the sole responsibility of the Company, and that the Agent shall have no obligation in connection with such compliance.
The issuance and sale of Placement Shares through or to the Agent will be effected pursuant to the Registration Statement (as defined
below) filed by the Company with the Securities and Exchange Commission (the “Commission”) April 8, 2022, amended
on April 15, 2022 and initially declared effective by the Commission on April 19, 2022, although nothing in this Agreement shall be construed
as requiring the Company to issue any Placement Shares.
The Company has prepared and filed, in accordance
with the provisions of the Securities Act of 1933, as amended, and the rules and regulations thereunder (collectively, the “Securities
Act”), with the Commission a registration statement on Form S-3 (File No. 333-264193), including a base prospectus, relating
to certain securities, including the Common Stock, to be issued from time to time by the Company, and which incorporates by reference
documents that the Company has filed or will file in accordance with the provisions of the Securities Exchange Act of 1934, as amended,
and the rules and regulations thereunder (collectively, the “Exchange Act”). The Company has prepared a prospectus
supplement to the base prospectus included as part of such registration statement at the time the registration statement became effective,
which prospectus supplement specifically relates to the Placement Shares to be issued from time to time pursuant to this Agreement (the
“Prospectus Supplement”). The Company will furnish to the Agent, for use by the Agent, copies of the base prospectus
included as part of such registration statement at the time it became effective, as supplemented by the Prospectus Supplement. Except
where the context otherwise requires, such registration statement, including all documents filed as part thereof or incorporated by reference
therein, and including any information contained in a Prospectus (as defined below) subsequently filed with the Commission pursuant to
Rule 424(b) under the Securities Act or deemed to be a part of such registration statement pursuant to Rule 430B or Rule 462(b) under
the Securities Act, is herein called the “Registration Statement.” The base prospectus, including all documents
incorporated therein by reference, included in the Registration Statement, as it may be supplemented by the Prospectus Supplement, in
the form in which such prospectus and/or Prospectus Supplement have most recently been filed by the Company with the Commission pursuant
to Rule 424(b) under the Securities Act, together with any “issuer free writing prospectus” (as used herein, as defined in
Rule 433 under the Securities Act (“Rule 433”)), relating to the Placement Shares that (i) is required
to be filed with the Commission by the Company or (ii) is exempt from filing pursuant to Rule 433(d)(5)(i), in each case, in the
form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records
pursuant to Rule 433(g), is herein called the “Prospectus.”
Any reference herein to the Registration Statement,
the Prospectus Supplement, the Prospectus or any issuer free writing prospectus shall be deemed to refer to and include the documents,
if any, that are or are deemed to be incorporated by reference therein (the “Incorporated Documents”), including,
unless the context otherwise requires, the documents, if any, filed as exhibits to such Incorporated Documents. Any reference herein to
the terms “amend,” “amendment” or “supplement” with respect to the Registration Statement, the Prospectus
Supplement, the Prospectus or any issuer free writing prospectus shall be deemed to refer to and include the filing of any document under
the Exchange Act on or after the most-recent effective date of the Registration Statement, or the respective dates of the Prospectus Supplement,
Prospectus or such issuer free writing prospectus, as the case may be, and incorporated therein by reference. For purposes of this Agreement,
all references to the Registration Statement, the Prospectus or any amendment or supplement thereto shall be deemed to include the most
recent copy filed with the Commission pursuant to its Electronic Data Gathering Analysis and Retrieval System or, if applicable, the Interactive
Data Electronic Application system when used by the Commission (collectively, “EDGAR”).
2. Placements.
Each time that the Company wishes to issue and sell any Placement Shares through or to the Agent hereunder (each, a “Placement”),
it will notify the Agent by email notice (or other method mutually agreed to in writing by the parties) (each such notice, a “Placement
Notice”) containing the parameters in accordance with which it desires such Placement Shares to be sold, which at a minimum
shall include the maximum number or amount of Placement Shares to be sold, the time period during which sales are requested to be made,
any limitation on the number or amount of Placement Shares that may be sold in any one Trading Day (as defined in Section 3) and any minimum
price below which sales may not be made, a form of which containing such minimum sales parameters is attached hereto as Schedule
1. The Placement Notice must originate from one of the individuals authorized to act on behalf of the Company and set forth on
Schedule 2 (with a copy to each of the other individuals from the Company listed on such Schedule 2), and
shall be addressed to each of the recipients from the Agent set forth on Schedule 2, as such Schedule 2 may
be updated by either party from time to time by sending a written notice containing a revised Schedule 2 to the other party
in the manner provided in Section 12 (including by email correspondence to each of the individuals of the Company set forth on Schedule
2, if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than
via auto-reply). The Placement Notice shall be effective upon receipt by the Agent unless and until (i) in accordance with the notice
requirements set forth in Section 4, the Agent declines to accept the terms contained therein for any reason, in its sole discretion,
within two Trading Days of the date the Agent receives the Placement Notice, (ii) in accordance with the notice requirements set forth
in Section 4, the Agent suspends sales under the Placement Notice for any reason in its sole discretion, (iii) the entire amount of the
Placement Shares has been sold pursuant to this Agreement, (iv) in accordance with the notice requirements set forth in Section 4,
the Company suspends sales under or terminates the Placement Notice for any reason in its sole discretion, (v) the Company issues a subsequent
Placement Notice and explicitly indicates that its parameters supersede those contained in the earlier dated Placement Notice or (vi)
this Agreement has been terminated pursuant to the provisions of Section 11. The amount of any discount, commission or other compensation
to be paid by the Company to the Agent in connection with the sale of the Placement Shares effected through or to the Agent shall be calculated
in accordance with the terms set forth in Schedule 3. It is expressly acknowledged and agreed that neither the Company nor
the Agent will have any obligation whatsoever with respect to a Placement or any Placement Shares unless and until the Company delivers
a Placement Notice to the Agent and the Agent does not decline such Placement Notice pursuant to the terms set forth above, and then only
upon the terms specified therein and herein. In the event of a conflict between the terms of this Agreement and the terms of a Placement
Notice, the terms of the Placement Notice will control with respect to the matters covered thereby.
3. Sale
of Placement Shares by the Agent. On the basis of the representations and warranties herein contained and subject to the terms and
conditions herein set forth, including Section 5(c), upon the Agent’s acceptance of the terms of a Placement Notice as provided
in Section 2, and unless the sale of the Placement Shares described therein has been declined, suspended or otherwise terminated in accordance
with the terms of this Agreement, the Agent, for the period specified in the Placement Notice, will use its commercially reasonable efforts
consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the
Nasdaq Capital Market (“Nasdaq”) to sell such Placement Shares up to the number or amount specified in, and
otherwise in accordance with the terms of, such Placement Notice. The Agent will provide written confirmation to the Company (including
by email correspondence to each of the individuals of the Company set forth on Schedule 2, if receipt of such correspondence
is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) no later than the opening of
the Trading Day (as defined below) immediately following the Trading Day on which it has made sales of Placement Shares hereunder setting
forth the number or amount of Placement Shares sold on such Trading Day, the volume-weighted average price of the Placement Shares sold
and the Net Proceeds (as defined below) payable to the Company. Unless otherwise specified by the Company in a Placement Notice, the Agent
may sell Placement Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of
the Securities Act. Notwithstanding the provisions of Section 6(tt), except as may be otherwise agreed by the Company and the Agent, the
Agent shall not purchase Placement Shares on a principal basis pursuant to this Agreement unless the Company and the Agent enter into
a separate written agreement setting forth the terms of such sale. The Company acknowledges and agrees that (i) there can be no assurance
that the Agent will be successful in selling Placement Shares, (ii) the Agent will incur no liability or obligation to the Company or
any other person or entity if it does not sell Placement Shares for any reason other than a failure by the Agent to use its commercially
reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations
and the rules of Nasdaq to sell such Placement Shares as required under this Agreement and (iii) the Agent shall be under no obligation
to purchase Placement Shares on a principal basis pursuant to this Agreement unless the Company and the Agent enter into a separate written
agreement setting forth the terms of such sale. For the purposes hereof, “Trading Day” means any day on which
the Common Stock is purchased and sold on Nasdaq.
4. Suspension
of Sales.
(a) The
Company or the Agent may, upon notice to the other party in writing (including by email correspondence to each of the individuals of the
other party set forth on Schedule 2, if receipt of such correspondence is actually acknowledged by any of the individuals
to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by email correspondence to each of the individuals
of the other party set forth on Schedule 2), suspend any sale of Placement Shares; provided, however, that
such suspension shall not affect or impair either party’s obligations with respect to any Placement Shares sold hereunder prior
to the receipt of such notice. Each of the parties agrees that no such notice under this Section 4 shall be effective against the other
party unless notice is sent by one of the individuals named on Schedule 2 hereto to the other party in writing (including
by email correspondence to each of the individuals of the other party set forth on Schedule 2, if receipt of such correspondence
is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply).
(b) Notwithstanding
any other provision of this Agreement, during any period in which the Company is, or could be deemed to be, in possession of material
non-public information, the Company and the Agent agree that (i) no sale of Placement Shares will take place, (ii) the Company shall not
request the sale of any Placement Shares and shall cancel any effective Placement Notices instructing the Agent to make any sales and
(iii) the Agent shall not be obligated to sell or offer to sell any Placement Shares.
5. Settlement
and Delivery of the Placement Shares.
(a) Settlement
of Placement Shares. Unless otherwise specified in the applicable Placement Notice, settlement for sales of Placement Shares will
occur on the second Trading Day (or such earlier day as is industry practice or as is required for regular-way trading) following the
date on which such sales are made (each, a “Settlement Date”). The amount of proceeds to be delivered to the
Company on a Settlement Date against receipt of the Placement Shares sold (the “Net Proceeds”) will be equal
to the aggregate gross sales price received by the Agent at which such Placement Shares were sold, after deduction of (i) the Agent’s
commission, discount or other compensation for such sales payable by the Company pursuant to Section 2 hereof, (ii) any other amounts
due and payable by the Company to the Agent hereunder pursuant to Section 7(g) hereof and (iii) any transaction fees imposed by any governmental
or self-regulatory organization in respect of such sales.
(b) Delivery
of Placement Shares. On or before each Settlement Date, the Company will issue the Placement Shares being sold on such date and will,
or will cause its transfer agent to, electronically transfer such Placement Shares by crediting the Agent’s or its designee’s
account (provided the Agent shall have given the Company written notice of such designee prior to the Settlement Date) at The Depository
Trust Company through its Deposit and Withdrawal at Custodian System (“DWAC”) or by such other means of delivery
as may be mutually agreed upon by the parties hereto, which in all cases shall be duly authorized, freely tradeable, transferable, registered
shares of Common Stock in good deliverable form. On each Settlement Date, the Agent will deliver the related Net Proceeds in same day
funds to an account designated by the Company on or prior to the Settlement Date. The Agent shall be responsible for providing DWAC instructions
or other instructions for delivery by other means with regard to the transfer of the Placement Shares being sold. In addition to and in
no way limiting the rights and obligations set forth in Section 9(a) hereto, the Company agrees that if the Company or its transfer agent
(if applicable), defaults in its obligation to deliver duly authorized, freely tradeable, transferable, registered Placement Shares in
good deliverable form by 2:30 P.M., New York City time, on a Settlement Date (other than as a result of a failure by the Agent to provide
instructions for delivery), the Company will (i) take all necessary action to cause the full amount of any Net Proceeds that were delivered
to the Company’s account with respect to such settlement, together with any costs incurred by the Agent and/or its clearing firm
in connection with recovering such Net Proceeds, to be immediately returned to the Agent or its clearing firm no later than 5:00 P.M.,
New York City time, on such Settlement Date, by wire transfer of immediately available funds to an account designated by the Agent or
its clearing firm, (ii) indemnify and hold the Agent and its clearing firm harmless against any loss, claim, damage, or expense (including
reasonable legal fees and expenses), as incurred, arising out of or in connection with such default by the Company or its transfer agent
(if applicable) and (iii) pay to the Agent any commission, discount or other compensation to which it would otherwise have been entitled
absent such default. Certificates for the Placement Shares, if any, shall be in such denominations and registered in such names as the
Agent may request in writing one Business Day (as defined below) before the applicable Settlement Date. Certificates for the Placement
Shares, if any, will be made available by the Company for examination and packaging by the Agent in New York City not later than 12:00
P.M., New York City time, on the Business Day prior to the applicable Settlement Date.
(c) Limitations
on Offering Size. Under no circumstances shall the Company cause or request the offer or sale of any Placement Shares if, after giving
effect to the sale of such Placement Shares, the aggregate number or gross sales proceeds of Placement Shares sold pursuant to this Agreement
would exceed the lesser of: (i) the number or dollar amount of shares of Common Stock registered pursuant to, and available for offer
and sale under, the Registration Statement pursuant to which the offering of Placement Shares is being made, (ii) the number of authorized
but unissued shares of Common Stock of the Company (less shares of Common Stock issuable upon exercise, conversion or exchange of any
outstanding securities of the Company or otherwise reserved from the Company’s authorized capital stock), (iii) the number or dollar
amount of shares of Common Stock permitted to be offered and sold by the Company under Form S-3 (including General Instruction I.B.6.
thereof, if such instruction is applicable), (iv) the number or dollar amount of shares of Common Stock that the Company’s
board of directors or a duly authorized committee thereof is authorized to issue and sell from time to time, and notified to the Agent
in writing, or (v) the dollar amount of shares of Common Stock for which the Company has filed the Prospectus Supplement. Under no circumstances
shall the Company cause or request the offer or sale of any Placement Shares pursuant to this Agreement at a price lower than the minimum
price authorized from time to time by the Company’s board of directors or a duly authorized committee thereof, and notified to the
Agent in writing. Notwithstanding anything to the contrary contained herein, the parties hereto acknowledge and agree that compliance
with the limitations set forth in this Section 5(c) on the number or dollar amount of Placement Shares that may be issued and sold under
this Agreement from time to time shall be the sole responsibility of the Company, and that the Agent shall have no obligation in connection
with such compliance.
6. Representations
and Warranties of the Company. The Company represents and warrants to, and agrees with, the Agent that as of the date of this Agreement,
and as of (i) each Representation Date (as defined in Section 7(m)), (ii) each date on which a Placement Notice is given, (iii) the date
and time of each sale of any Placement Shares pursuant to this Agreement and (iv) each Settlement Date (each such time or date referred
to in clauses (i) through (iv), an “Applicable Time”):
(a) The
Company and the transactions contemplated by this Agreement meet the requirements for and comply with the conditions for the use of Form
S-3 (including General Instructions I.A and I.B.1.) under the Securities Act. The Registration Statement has been filed with the Commission
and has been declared effective by the Commission under the Securities Act prior to the issuance of any Placement Notices by the Company.
At the time the Registration Statement originally became effective and at the time the Company’s most recent Annual Report on Form
10-K was filed with the Commission, the Company met the then-applicable requirements for use of Form S-3 (including General Instructions
I.A and I.B.6.) under the Securities Act. The Registration Statement meets, and the offering and sale of Placement Shares as contemplated
hereby comply with, the requirements of Rule 415(a)(1)(x) under the Securities Act. The Agent is named as the agent engaged by the Company
in the section entitled “Plan of Distribution” in the Prospectus Supplement. The Company has not received, and has no notice
from the Commission of, any notice pursuant to Rule 401(g)(1) under the Securities Act objecting to the use of the shelf registration
statement form. No stop order of the Commission preventing or suspending the use of the base prospectus, the Prospectus Supplement or
the Prospectus, or the effectiveness of the Registration Statement, has been issued, and no proceedings for such purpose are pending before
or, to the knowledge of the Company, threatened by the Commission. At the time of the initial filing of the Registration Statement, the
Company paid the required Commission filing fees relating to the securities covered by the Registration Statement, including the Shares
that may be sold pursuant to this Agreement, in accordance with Rule 457(o) under the Securities Act. Copies of the Registration Statement,
the Prospectus, any such amendments or supplements to any of the foregoing and all Incorporated Documents that were filed with the Commission
on or prior to the date of this Agreement have been delivered, or are available through EDGAR, to the Agent and its counsel.
(b) Each
of the Registration Statement and any post-effective amendment thereto, at the time it became or becomes effective, at each deemed effective
date with respect to the Agent pursuant to Rule 430B(f)(2) under the Securities Act and as of each Applicable Time, complied, complies
and will comply in all material respects with the requirements of the Securities Act and did not, does not and will 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 therein
not misleading, except that the representations and warranties set forth in this sentence do not apply to Agent’s Information (as
defined below). The Prospectus and any amendment or supplement thereto, when so filed with the Commission under Rule 424(b) under the
Securities Act, complied, complies and as of each Applicable Time will comply in all material respects with the requirements of the Securities
Act, and each Prospectus Supplement, Prospectus or issuer free writing prospectus (or any amendments or supplements to any of the foregoing)
furnished to the Agent for use in connection with the offering of the Placement Shares was identical to the electronically transmitted
copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T. Neither the Prospectus nor
any amendment or supplement thereto, as of its date and as of each Applicable Time, included, includes or will include an untrue statement
of a material fact or omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in the light
of the circumstances under which they were made, not misleading, except that the representations and warranties set forth in this sentence
do not apply to Agent’s Information. Each Incorporated Document heretofore filed, when it was filed (or, if any amendment with respect
to any such document was filed, when such amendment was filed), conformed in all material respects with the requirements of the Exchange
Act and were filed on a timely basis with the Commission, and any further Incorporated Documents so filed and incorporated after the date
of this Agreement will be filed on a timely basis and, when so filed, will conform in all material respects with the requirements of the
Exchange Act; no such Incorporated Document when it was filed (or, if an amendment with respect to any such document was filed, when such
amendment was filed), contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein
or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and
no such Incorporated Document, when it is filed, will contain an untrue statement of a material fact or will omit to state a material
fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they
were made, not misleading.
(c) (i)
At the time of filing the Registration Statement and (ii) at the time of the execution of this Agreement (with such date being used as
the determination date for purposes of this clause (ii)), the Company was not and is not an “ineligible issuer” (as defined
in Rule 405), without taking account of any determination by the Commission pursuant to Rule 405 that it is not necessary that the Company
be considered an ineligible issuer.
(d) [Intentionally
omitted].
(e) Each
issuer free writing prospectus, as of its issue date and as of each Applicable Time, did not, does not and will not include any information
that conflicted, conflicts or will conflict with the information contained in the Registration Statement or the Prospectus, including
any Incorporated Document deemed to be a part thereof that has not been superseded or modified. Each issuer free writing prospectus that
the Company has filed, or is required to file, pursuant to Rule 433 or that was prepared by or on behalf of or used by the Company complies
or will comply in all material respects with the requirements of the Securities Act.
(f) The
Company has not distributed and, prior to the later to occur of each Settlement Date and completion of the Agent’s distribution
of the Placement Shares under this Agreement, will not distribute any offering material in connection with the offering and sale of the
Placement Shares other than the Registration Statement, the Prospectus or any Permitted Free Writing Prospectus (as defined below).
(g) The
interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement and the
Prospectus fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s
rules and guidelines applicable thereto.
(h) The
Company is subject to and in compliance in all material respects with the reporting requirements of Section 13 or Section 15(d) of the
Exchange Act. The Common Stock is registered pursuant to Section 12(b) of the Exchange Act and is listed on Nasdaq, and the Company has
taken no action designed to, or reasonably likely to have the effect of, terminating the registration of the Common Stock under the Exchange
Act or delisting the Common Stock from Nasdaq, nor has the Company received any notification that the Commission or Nasdaq is contemplating
terminating such registration or listing. The Company is in compliance with the current listing standards of Nasdaq. The Company has filed
a Notification of Listing of Additional Shares with Nasdaq with respect to the Placement Shares.
(i) No
person (as such term is defined in Rule 1-02 of Regulation S-X promulgated under the Securities Act) has the right to act as an underwriter
or as a financial advisor to the Company in connection with the offer and sale of the Placement Shares hereunder, whether as a result
of the filing or effectiveness of the Registration Statement or the sale of the Placement Shares as contemplated hereby or otherwise.
Except for the Agent, there is no broker, finder or other party that is entitled to receive from the Company or any of its Subsidiaries
(as defined below) any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this
Agreement.
(j) The
Company has been duly organized and is validly existing as a corporation in good standing under the laws of the State of Nevada, with
full corporate power and authority to acquire, own, lease and operate its properties, and to lease the same to others, and to conduct
its business as described in the Registration Statement and the Prospectus and to enter into and perform its obligations under this Agreement.
The Company is duly qualified to transact business as a foreign corporation and is in good standing in the State of Delaware and under
the laws of each other jurisdiction that requires such qualification, whether by reason of the ownership or leasing of property or the
conduct of business, except to the extent that the failure to be so qualified or in good standing could not reasonably be expected, individually
or in the aggregate, to have a material adverse effect on the condition (financial or otherwise), earnings, results of operations, business,
properties, operations, assets, liabilities or prospects of the Company and its Subsidiaries, taken as a whole, whether or not arising
from transactions in the ordinary course of business (a “Material Adverse Effect”).
(k) Each
of the Company’s “subsidiaries” (for purposes of this Agreement, as defined in Rule 405 under the Securities Act) (each,
a “Subsidiary” and collectively, the “Subsidiaries”) has been duly organized and is
validly existing in good standing (where such concept exists) under the laws of the jurisdiction of its organization and has full power
and authority to acquire, own, lease and operate its properties, and to conduct its business as described in the Registration Statement
and the Prospectus. Each Subsidiary is duly qualified to transact business and is in good standing (where such concept exists) under the
laws of each jurisdiction that requires such qualification, whether by reason of the ownership or leasing of property or the conduct of
business, except to the extent that the failure to be so qualified or in good standing could not reasonably be expected, individually
or in the aggregate, to have a Material Adverse Effect. All of the issued and outstanding share capital or other equity or ownership interests
of each Subsidiary has been duly authorized and validly issued, is fully paid and nonassessable, has been issued in compliance with federal
state and securities laws and is owned by the Company, directly or through other wholly-owned Subsidiaries, free and clear of any security
interest, mortgage, pledge, lien, encumbrance or adverse claim. The Company does not own or control, directly or indirectly, any corporation,
association or other entity, other than the Subsidiaries listed on Exhibit 21.1 to the Company’s most recent Annual Report on Form
10-K filed with the Commission. No Subsidiary is prohibited or restricted, directly or indirectly, from paying dividends to the Company,
from making any other distribution with respect to such Subsidiary’s equity securities, from repaying to the Company or any other
Subsidiary any amounts that may from time to time become due under any loans or advances to such Subsidiary from the Company or from transferring
any property or assets to the Company or to any other Subsidiary.
(l) The
Company has the authorized and outstanding capitalization as set forth in the Company’s annual report on Form 10-K for the most
recent fiscal year or, if later, the Company’s quarterly report on Form 10-Q for the most recent fiscal quarter, as of the dates
referred to therein (subject, in each case, to the issuance of Placement Shares under this Agreement, the issuance of shares of Common
Stock upon exercise of share options and warrants disclosed as outstanding as of the date hereof in the Registration Statement and the
Prospectus and the grant of options under existing share option plans described in the Registration Statement and the Prospectus). The
Common Stock conforms in all material respects to the description thereof contained in the Registration Statement and the Prospectus,
including under the heading “Description of Capital Stock.” All of the issued and outstanding share capital or other equity
or ownership interest of the Company (including the Common Stock) has been duly authorized and validly issued and is fully paid and nonassessable,
has been issued in compliance with all federal, state and local securities laws and is free and clear of any security interest, mortgage,
pledge, lien, encumbrance or adverse claim. None of the outstanding shares of capital stock of the Company were issued in violation of
any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase securities of the Company. There are
no authorized or outstanding options, warrants, preemptive rights, rights of first refusal or other rights to purchase or subscribe for,
or equity or debt securities convertible into or exchangeable or exercisable for, any share capital of the Company or any of its Subsidiaries
or to which the Company or any of its Subsidiaries is a party or by which any of them may be bound. The descriptions of the Company’s
equity incentive plan, stock option plans and other stock plans or arrangements described in the Prospectus and in effect as of the date
hereof (collectively, the “Stock Plans”) and the options or other rights granted thereunder, set forth in the
Registration Statement and the Prospectus accurately and fairly present the information required to be shown with respect to such Stock
Plans and the options or other rights granted thereunder.
(m) The
Placement Shares have been duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by the Company
against payment therefor pursuant to this Agreement, will be validly issued, fully paid and nonassessable and will conform in all material
respects to the description thereof contained in the Prospectus. The issuance and sale of the Placement Shares as contemplated hereby
shall not be subject to any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase the Placement
Shares. When issued and delivered by the Company against payment therefor pursuant to this Agreement, the purchasers of the Placement
Shares issued and sold hereunder will acquire good, marketable and valid title to such Placement Shares, free and clear of all pledges,
liens, security interests, charges, claims or encumbrances. The issuance and sale of the Placement Shares as contemplated hereby will
not cause any holder of any share capital, securities convertible into or exchangeable or exercisable for share capital or options, warrants
or other rights to purchase share capital or any other securities of the Company to have any right to acquire any preferred shares of
the Company. There are no restrictions upon the voting or transfer of the Common Stock under the Company’s amended and restated
certificate of incorporation or amended and restated bylaws or any agreement or other instrument to which the Company is a party or otherwise
filed as an exhibit to the Registration Statement.
(n) There
is no statute, regulation, contract, agreement or other document required to be described in the Registration Statement, Prospectus or
in any Incorporated Document, or to be filed as an exhibit to the Registration Statement or any Incorporated Document which is not described
or filed as required. The statements set forth or incorporated by reference in the Prospectus, insofar as they purport to constitute summaries
of the terms of the statutes, regulations, contracts, agreements or other documents described and filed, constitute accurate summaries
of the terms thereof in all material respects. The statements set forth or incorporated by reference in the Prospectus under the headings
“Risk Factors,” “Business—Intellectual Property,” “Business—Government Regulation,” “Legal
Proceedings,” and “Description of Capital Stock,” insofar as such statements summarize legal matters, agreements, documents
or proceedings discussed therein, are accurate and fair summaries of such legal matters, agreements, documents or proceedings. Neither
the Company nor any of its Subsidiaries has sent or received any communication regarding termination of, or intent not to renew or render
performance under, any of the contracts or agreements referred to or described in the Prospectus or any free writing prospectus, or referred
to or described in, or filed as an exhibit to, the Registration Statement, or any Incorporated Document, and no such termination or non-renewal
has been threatened by the Company or any of its Subsidiaries or, to the Company’s knowledge, any other party to any such contract
or agreement, which threat of termination or non-renewal has not been rescinded as of the date hereof.
(o) This
Agreement has been duly and validly authorized, executed and delivered by the Company and constitutes a valid and legally binding obligation
of the Company, enforceable against the Company in accordance with its terms, except as enforceability, including rights of indemnification,
may be limited by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting
creditors’ rights generally and by general principles of equity. This Agreement conforms in all material respects to the descriptions
thereof in the Registration Statement and the Prospectus.
(p) The
Company is not and, after giving effect to the offering and sale of the Placement Shares and the application of the proceeds thereof as
described in the Prospectus, will not be an “investment company” as defined in the Investment Company Act of 1940, as amended.
(q) No
consent, approval, license, permit, qualification, authorization or other order or decree of, or registration or filing with, any court
or other governmental, taxing or regulatory authority or agency, is required for the Company’s execution, delivery and performance
of this Agreement or consummation of the transactions contemplated hereby or by the Registration Statement and the Prospectus (including
the issuance and sale of the Placement Shares hereunder), except such as have been already obtained or made or as may be required under
the Securities Act, applicable state securities or Blue Sky laws, applicable rules of Nasdaq, or Rule 5110 of the Financial Industry Regulatory
Authority, Inc. (“FINRA”).
(r) Neither
the execution and delivery by the Company of, nor the performance of the Company of its obligations under, this Agreement will conflict
with, result in a breach or violation of, or result in the creation or imposition of any lien, charge or encumbrance upon any property
or assets of the Company or any of its Subsidiaries pursuant to: (i) the certificate or articles of incorporation, charter, bylaws, articles
of association, limited liability company agreement, certificate or agreement of limited or general partnership or other similar organizational
documents, as the case may be, of such entity, (ii) the terms of any indenture, contract, license, lease, mortgage, deed of trust, note
agreement, agreement or other instrument, obligation, condition, covenant or instrument to which it is a party or bound or to which its
property or assets is subject or (iii) any statute, law, rule, regulation, judgment, order or decree applicable to the Company or any
of its Subsidiaries of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction
over the Company, any of its Subsidiaries or any of their respective properties or assets, as applicable, except, in the case of clauses
(ii) and (iii) above, for any such conflict, breach, violation or default that would not, individually or in the aggregate, have a Material
Adverse Effect.
(s) Subsequent
to the respective dates as of which information is given in the Registration Statement and the Prospectus: (i) there has been no material
adverse change, or any development that could reasonably be expected to result in a material adverse change, in the condition (financial
or otherwise), earnings, results of operations, business, properties, operations, assets, liabilities or prospects of the Company and
its Subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business; (ii) neither the Company
nor its Subsidiaries has (A) incurred any material liability or obligation, indirect, direct or contingent, including without limitation
any losses or interference with its business from fire, explosion, flood, earthquakes, accident or other calamity, whether or not covered
by insurance, or from any strike, labor dispute or court or governmental action, order or decree, that are material, individually or in
the aggregate, to the Company and its Subsidiaries, considered as one entity, (B) entered into any material transactions not in the ordinary
course of business or (C) issued or granted any shares of the Company’s capital stock or securities convertible into or exchangeable
or exercisable for or that represent the right to receive shares of the Company’s capital stock other than under the Stock Plans;
and (iii) there has not been any material decrease in the share capital or any material increase in any short-term or long-term indebtedness
of the Company or any of its Subsidiaries and there has been no dividend or distribution of any kind declared, paid or made by the Company
or, except for dividends paid to the Company or another Subsidiary, by any Subsidiary on any class of shares, or any repurchase or redemption
by the Company or any of its Subsidiaries of any class of shares.
(t) There
are no persons (as such term is defined in Rule 1-02 of Regulation S-X promulgated under the Securities Act) with registration or other
similar rights to have any equity or debt securities of the Company registered for sale under the Registration Statement or included in
the offering contemplated by this Agreement, except for such rights as have been duly waived in a writing previously furnished to the
Agent.
(u) The
financial statements included or incorporated by reference in the Registration Statement and the Prospectus, together with the related
notes and schedules, present fairly the consolidated financial position of the Company and the Subsidiaries as of the dates indicated
and the consolidated results of operations, cash flows and changes in stockholders’ equity of the Company and the Subsidiaries for
the periods specified and have been prepared in compliance with the requirements of the Securities Act and Exchange Act and in conformity
with United States generally accepted accounting principles (“GAAP”) applied on a consistent basis during the
periods involved. To the extent applicable, any pro forma financial statements, information or data included or incorporated by reference
in the Registration Statement and the Prospectus comply with the requirements of Regulation S-X of the Securities Act, including, without
limitation, Article 11 thereof, fairly present the information set forth herein, and the assumptions used in the preparation of such pro
forma financial statements and data are reasonable, the pro forma adjustments used therein are appropriate to give effect to the circumstances
referred to therein and the pro forma adjustments have been properly applied to the historical amounts in the compilation of those statements
and data. The other financial data set forth or incorporated by reference in the Registration Statement and the Prospectus is accurately
and fairly presented and prepared on a basis consistent with the financial statements and books and records of the Company. There are
no financial statements (historical or pro forma) that are required to be included or incorporated by reference in the Registration Statement
or the Prospectus that are not included or incorporated by reference therein as required. The Company and the Subsidiaries do not have
any material liabilities or obligations, direct or contingent (including any off-balance sheet obligations or any “variable interest
entities” as that term is used in Accounting Standards Codification Paragraph 810-10-25-20), not disclosed in the Registration Statement
and the Prospectus. All disclosures contained in the Registration Statement or the Prospectus that contain “non-GAAP financial measures”
(as such term is defined by the rules and regulations of the Commission) comply, in all material respects, with Regulation G under the
Exchange Act and Item 10 of Regulation S-K under the Securities Act, to the extent applicable. The statistical, industry-related and market-related
data included or incorporated by reference in the Registration Statement and the Prospectus were obtained or derived from sources which
the Company reasonably and in good faith believes are reliable and accurate, such data agree with the sources from which they are derived,
and the Company has obtained the written consent to the use of such data from such sources to the extent required. To the Company’s
knowledge, no person who has been suspended or barred from being associated with a registered public accounting firm, or who has failed
to comply with any sanction pursuant to Rule 5300 promulgated by the Public Company Accounting Oversight Board (“PCAOB”),
has participated in or otherwise aided the preparation of, or audited, the financial statements, supporting schedules or other financial
data filed with the Commission as a part of the Registration Statement and the Prospectus.
(v) There
are no actions, suits, claims, investigations or proceedings pending or, to the Company’s knowledge, threatened to which the Company
or any of the Subsidiaries is or would be a party, or of which any of the respective properties or assets of the Company and the Subsidiaries
is or would be subject, at law or in equity, before any court or arbitral body or by or before any federal, state, local or foreign governmental
or regulatory commission, board, body, authority or agency, that (i) are required to be described in the Registration Statement or the
Prospectus and are not so described, (ii) could reasonably be expected to have a material adverse effect on the ability of the Company
to perform its obligations under this Agreement or on the consummation of any of the transactions contemplated hereby or (iii) could reasonably
be expected to have a Material Adverse Effect. The aggregate of all pending legal or governmental proceedings to which the Company or
any of its Subsidiaries is a party or of which any of their respective properties or assets is the subject which are not described in
the Prospectus, including ordinary routine litigation incidental to the Company’s business, could not reasonably be expected to
(A) result in a Material Adverse Effect or (B) have a material adverse effect on the ability of the Company to perform its obligations
under this Agreement or the consummation of any of the transactions contemplated hereby.
(w) The
Company owns or leases all such real properties as are necessary to the conduct of its operations as presently conducted in all material
respects.
(x) Neither
the Company nor any Subsidiary is in violation or default of (i) any provision of its certificate or articles of incorporation, charter,
bylaws, articles of association, limited liability company agreement, certificate or agreement of limited or general partnership, or other
similar organizational documents, as the case may be, of such entity, (ii) the terms of any indenture, contract, lease, mortgage, deed
of trust, note agreement, loan agreement or other agreement, obligation, condition, covenant or instrument to which it is a party or bound
or to which its property or assets is subject, or (iii) any statute, law, rule, regulation, judgment, order or decree of any court, regulatory
body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company, any of its Subsidiaries
or any of their respective properties or assets, as applicable, except, in the case of clauses (ii) and (iii) above, for any such default
or violation that would not, individually or in the aggregate, have a Material Adverse Effect.
(y) Farber
Hass Hurley LLP, whose report on the consolidated financial statements of the Company is filed with the Commission as part of the Company’s
most recent annual report on Form 10-K filed with the Commission and incorporated by reference in the Registration Statement and the Prospectus,
is (i) an independent registered public accounting firm as required by the Securities Act, the Exchange Act and the rules of the PCAOB,
(ii) in compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X under
the Securities Act and (iii) a registered public accounting firm as defined by the PCAOB whose registration has not been suspended or
revoked and who has not requested such registration to be withdrawn. Farber Hass Hurley LLP has not been engaged by the Company to perform
any “prohibited activities” or provided to the Company any “non-audit services” (as defined in Section 10A of
the Exchange Act).
(z) There
are no transfer taxes or other similar fees or charges under federal law, the laws of any state, any foreign law, or any political subdivision
thereof, required to be paid in connection with the execution and delivery of this Agreement or the issuance by the Company or sale by
the Company of the Placement Shares.
(aa) All United States federal income tax returns
of the Company and its Subsidiaries required by law to be filed have been filed or extensions thereof have been requested, and all taxes
shown by such returns or otherwise assessed, which are due and payable, have been paid, except assessments that are being contested in
good faith and as to which adequate reserves have been provided under GAAP. The Company has no knowledge of any material tax deficiency
which has been or is likely to be threatened or asserted against the Company or its Subsidiaries. Each of the Company and its Subsidiaries
has filed all foreign, state, provincial, local or other tax returns that are required to have been filed pursuant to applicable foreign,
state, provincial, local or other law except insofar as the failure to file such returns would not, individually or in the aggregate,
reasonably be expected to result in a Material Adverse Effect, and paid all taxes due pursuant to such returns or pursuant to any assessment
received by the Company and its Subsidiaries, except for such taxes, if any, as are being contested in good faith and as to which adequate
reserves have been provided and except for such taxes or assessments the nonpayment of which would not, individually or in the aggregate,
reasonably be expected to result in a Material Adverse Effect. The charges, accruals and reserves on the books of the Company and its
Subsidiaries in respect of any income or other tax liability for any years not finally determined are adequate to meet any assessments
or re-assessments for additional tax for any years not finally determined, except to the extent of any inadequacy that would not reasonably
be expected to result in a Material Adverse Effect. All material taxes which the Company and its Subsidiaries are required by law to withhold
or to collect for payment have been duly withheld and collected and have been paid to the appropriate governmental authority or agency
or have been accrued, reserved against and entered on the books of the Company and its Subsidiaries.
(bb) No labor dispute with the employees of
the Company or any of its Subsidiaries exists or, to the Company’s knowledge, is threatened or imminent, and the Company is not
aware of any existing, threatened or imminent labor disturbance by the employees of any of its or any of its Subsidiaries’ principal
suppliers, manufacturers, contractors or customers, in each case that would have a Material Adverse Effect. None of the employees of the
Company or any of its Subsidiaries is represented by a union and, to the knowledge of the Company, no union organizing activities are
taking place. Neither the Company nor any of its Subsidiaries has violated (or received notice of any violation of) any federal, state
or local law or foreign law relating to the discrimination in hiring, promotion or pay of employees, nor any applicable wage or hour laws,
or the rules and regulations thereunder, or analogous foreign laws and regulations, which would, individually or in the aggregate, reasonably
be expected to result in a Material Adverse Effect.
(cc) Each of the Company and its Subsidiaries
are insured by recognized and reputable institutions with policies in such amounts and with such deductibles and covering such risks as
are generally deemed adequate and customary for their businesses including, but not limited to, policies covering real and personal property
owned or leased by the Company and its Subsidiaries against theft, damage, destruction, acts of vandalism and earthquakes and policies
covering the Company and its Subsidiaries for clinical trial liability claims. The Company has no reason to believe that it or any of
its Subsidiaries will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain comparable
coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that could
not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has been denied any material
insurance coverage which it has sought or for which it has applied.
(dd) The Company and each of its Subsidiaries
has good and marketable title in fee simple to all real property owned by them and good and marketable title to all personal property
owned by them that is material to their business (except with respect to intellectual property, which is addressed exclusively in Section
6(pp) and Section 6(ggg) below), in each case free and clear of all liens, encumbrances and defects except such as do not materially affect
the value of such property and do not interfere with the use made and proposed to be made of such property by the Company or any Subsidiary;
and any real property and buildings held under lease by the Company or any of its Subsidiaries are held by them under valid, subsisting
and enforceable leases (subject to the effects of (A) bankruptcy, insolvency, fraudulent conveyance, fraudulent transfer, reorganization,
moratorium or other similar laws relating to or affecting the rights or remedies of creditors generally; (B) the application of general
principles of equity (including, without limitation, concepts of materiality, reasonableness, good faith and fair dealing, regardless
of whether enforcement is considered in proceedings at law or in equity); and (C) applicable law and public policy with respect to rights
to indemnity and contribution) with such exceptions as are not material and do not interfere with the use made and proposed to be made
of such property and buildings by the Company or such Subsidiary.
(ee) The Company and its Subsidiaries possess
and are operating in compliance with such valid and current material certificates, authorizations or permits required by United States
federal, state or foreign regulatory agencies or bodies to conduct their respective businesses as currently conducted and as described
in the Registration Statement and the Prospectus (collectively, “Permits”). Neither the Company nor any of its
Subsidiaries is in violation of, or in default under, any of the Permits or has received any written notice of proceedings relating to
the revocation or modification of, or non-compliance with, any such certificate, authorization or permit, which, individually or in the
aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse
Effect.
(ff) The Company and each of its Subsidiaries
make and keep accurate books and records and maintain a system of internal accounting controls sufficient to provide reasonable assurance
that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions
are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain accountability for assets;
(iii) access to assets is permitted only in accordance with management’s general or specific authorization; (iv) the recorded accountability
for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences; and
(v) the interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement
and the Prospectus fairly presents the information called for in all material respects and is prepared in accordance with the Commission’s
rules and guidelines applicable thereto.
(gg) The Company and each of its Subsidiaries
have established and maintain disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which
(i) are designed to ensure that information relating to the Company, including its consolidated Subsidiaries, is made known to the Company’s
principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which
the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness
as of the end of the Company’s most recent fiscal quarter; and (iii) are effective in all material respects to perform the functions
for which they were established. Since the end of the Company’s most recent audited fiscal year, there has been no material weakness
in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal
control over financial reporting, including any corrective actions with regard to significant deficiencies or material weaknesses. The
Company is not aware of any change in its internal control over financial reporting that has occurred during its most recent fiscal quarter
that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
(hh) Neither the Company, nor any of its Subsidiaries,
nor to the knowledge of the Company, any of its or their respective directors, officers or controlling persons has taken, directly or
indirectly, without giving effect to any actions taken by the Agent, (i) any action designed to or that might constitute or reasonably
be expected to cause or result in, under the Exchange Act or otherwise, stabilization or manipulation of the price of any security of
the Company to facilitate the sale or resale of the Placement Shares or (ii) any action designed to or that might constitute or reasonably
be expected to cause or result in a violation of Regulation M under the Exchange Act.
(ii) Except
as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect: (i) neither the Company nor
any of its Subsidiaries is in violation of any United States federal, state or local, or any foreign, statute, law, rule, regulation,
ordinance, code, policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative
order, consent, decree or judgment, relating to pollution or protection of human health, the environment (including, without limitation,
ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations
relating to the emissions, discharges, release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances,
hazardous substances, petroleum or petroleum products (collectively, “Hazardous Materials”) or otherwise related
to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively,
“Environmental Laws”), which violation includes, but is not limited to, noncompliance with any permits or other
governmental authorizations required for the operation of the business of the Company or any of its Subsidiaries under applicable Environmental
Laws, or noncompliance with the terms and conditions thereof, nor has the Company or any of its Subsidiaries received any written communication,
whether from a governmental authority, citizens group, employee or otherwise, that alleges that the Company or any of its Subsidiaries
is in violation of any Environmental Law; (ii) the Company and its Subsidiaries have all material permits, authorizations and approvals
required under any applicable Environmental Laws and are in compliance with their requirements; (iii) there are no pending or, to the
Company’s knowledge, threatened administrative, regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices
of noncompliance or violation, investigation or proceedings relating to any Environmental Law against the Company or any of its Subsidiaries,
or any investigation with respect to which the Company or any of its Subsidiaries has received written notice or any written notice by
any person or entity alleging potential liability for investigatory costs, cleanup costs, governmental responses costs, natural resources
damages, property damages, personal injuries, attorneys’ fees or penalties arising out of, based on or resulting from the presence,
or release into the environment, of any Hazardous Materials at any location owned, leased or operated by the Company or any of its Subsidiaries,
now or in the past; and (iv) to the Company’s knowledge, there are no past or present actions, activities, events, conditions, incidents
or circumstances that might reasonably be expected to result in a violation of any Environmental Law or form the basis of an order for
clean-up or remediation, or an action, suit, investigation or proceeding by any private party or governmental body or agency, against
or affecting the Company or any of its Subsidiaries relating to Hazardous Materials or any Environmental Laws.
(jj) The Company and any “employee benefit
plan” (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published interpretations
thereunder (collectively, “ERISA”)) established or maintained by the Company, or its “ERISA Affiliates”
(as defined below) are in compliance in all material respects with ERISA. “ERISA Affiliates” means, with respect to the Company,
any member of any group of organizations described in Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended,
and the regulations and published interpretations thereunder (the “Code”) of which the Company is a member.
No “reportable event” (as defined under ERISA) has occurred or is reasonably expected to occur with respect to any “employee
benefit plan” established or maintained by the Company, or any of its ERISA Affiliates. No “employee benefit plan” established
or maintained by the Company or any of its ERISA Affiliates, if such “employee benefit plan” were terminated, would have any
“amount of unfunded benefit liabilities” (as defined under ERISA). Neither the Company nor any of its ERISA Affiliates has
incurred or reasonably expects to incur any liability under (i) Title IV of ERISA with respect to termination of, or withdrawal from,
any “employee benefit plan” or (ii) Sections 412, 4971, 4975 or 4980B of the Code. Each “employee benefit plan”
established or maintained by the Company or any of its ERISA Affiliates that is intended to be qualified under Section 401(a) of the Code
is so qualified and nothing has occurred, whether by action or failure to act, which would cause the loss of such qualification.
(kk) The Company is in compliance with, and
there is and has been no failure on the part of the Company and, to the Company’s knowledge, any of the Company’s directors
or officers, in their capacities as such, to comply with, any provision of the Sarbanes-Oxley Act of 2002 and all rules and regulations
promulgated thereunder or implementing the provisions thereof (the “Sarbanes-Oxley Act”) and the rules and regulations
promulgated in connection therewith, including Section 402 relating to loans.
(ll) Neither the Company, any of its Subsidiaries,
nor, to the knowledge of the Company, any of their respective directors, officers, agents, employees or affiliates, has taken or will
take any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the unlawful payment or giving of
money, property, gifts or anything else of value, directly or indirectly, to any “government official” (including any officer
or employee of a government or government-owned or controlled entity or of a public international organization, or any person acting in
an official capacity for or on behalf of any of the foregoing, or any political party or party official or candidate for political office)
to influence official action or secure an improper advantage; and the Company, each of its Subsidiaries and, to the Company’s knowledge,
each of their respective affiliates have conducted their businesses in compliance with applicable anti-corruption laws.
(mm) None of the Company, any Subsidiary, affiliate,
director, officer or employee thereof or, to the best of the Company’s knowledge, any agent, representative or other person acting
on behalf of the Company or any of its Subsidiaries or affiliates, is aware of or has taken any action, directly or indirectly, that would
result in a violation by such persons of any applicable anti-corruption laws, including the Foreign Corrupt Practices Act of 1977, as
amended, and the rules and regulations thereunder (the “FCPA”), including, without limitation, making use of
the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization
of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign
official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign
political office or otherwise took any action (or failed to fully disclose any action) in contravention of the FCPA; and the Company,
its Subsidiaries and each of their respective affiliates have conducted their businesses in compliance with the FCPA and have instituted
and maintain, and will continue to maintain, policies and procedures designed to ensure, and which are reasonably expected to continue
to ensure, continued compliance therewith.
(nn) The operations of the Company and its Subsidiaries
are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements and the money
laundering statutes and the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered
or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit, investigation
or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its Subsidiaries
with respect to the Money Laundering Laws is pending or, to the best of the Company’s knowledge, threatened.
(oo) Neither
the Company nor any of its Subsidiaries, nor any director or officer thereof, nor, to the Company’s knowledge, any employee, agent,
affiliate or representative of the Company or any of its Subsidiaries, is currently or is owned or controlled by an individual or entity
that is subject to any sanctions administered or enforced by the United States government (including, without limitation, the Office of
Foreign Assets Control of the United States Department of the Treasury), the United Nations Security Council, the European Union, His
Majesty’s Treasury or other relevant sanctions authority (collectively, “Sanctions”) or is located, organized
or resident in a country or territory that is the subject or target of Sanctions; and the Company will not directly or indirectly use
the proceeds of the sale of the Placement Shares, or lend, contribute or otherwise make available such proceeds to any Subsidiary, or
any joint venture partner or other person or entity, for the purpose of financing or facilitating the activities of or business of any
person or entity, or in any country or territory, that currently or at the time of such financing or facilitation is the subject of any
Sanctions or in any other manner that will result in a violation by any person or entity (including any person participating in the transactions
contemplated by this Agreement) of any Sanctions. For the past five years, the Company and its Subsidiaries have not knowingly engaged
in and are not now knowingly engaged in any dealings or transactions with any person or entity, or in any country or territory, that at
the time of the dealing or transaction is or was the subject of Sanctions.
(pp) The Company and its Subsidiaries own or
possess the right to use all inventions, patent applications, patents, trademarks, trade names, service names, domain names, copyrights,
trade secrets, know-how and other intellectual property (collectively, “Intellectual Property”) as are (i) necessary
or material for the conduct of their respective businesses as currently conducted or as currently proposed to be conducted and as described
in the Registration Statement and the Prospectus and (ii) necessary or material for the commercialization of the products described in
the Registration Statement and the Prospectus as being under development. There is no pending or, to the Company’s knowledge, threatened
(i) action, suit, proceeding, or claim by others challenging the rights of the Company or any of its Subsidiaries in or to any such Intellectual
Property that, if decided adversely to the Company or such Subsidiary would, individually or in the aggregate, have a Material Adverse
Effect, and the Company is unaware of any facts which would form a reasonable basis for any such claim; (ii) action, suit, proceeding,
or claim by others that the Company or any of its Subsidiaries infringes, misappropriates, or otherwise violates any Intellectual Property
of others that, if decided adversely to the Company or such Subsidiary would, individually or in the aggregate, have a Material Adverse
Effect, and the Company is unaware of any facts which would form a reasonable basis for any such claim; or (iii) action, suit, proceeding,
or claim by others challenging the validity, scope, or enforceability of any such Intellectual Property owned or licensed by the Company
or its Subsidiaries and the Company is unaware of any facts which would form a reasonable basis for any such claim. To the best of the
Company’s knowledge, the operation of the business of the Company and its Subsidiaries as now conducted, and as described in the
Prospectus, and in connection with the development and commercialization of the products described in the Prospectus does not infringe,
misappropriate, conflict with or otherwise violate any claim of any patent or published patent application of any other person or entity.
There is no prior art of which the Company or any of its Subsidiaries is aware that may render any patent owned or licensed by the Company
or its Subsidiaries invalid or any patent application owned or licensed by the Company or its Subsidiaries unpatentable which has not
been disclosed to the applicable government patent office. The Company’s granted or issued patents, registered trademarks and registered
copyrights have been duly maintained and are in full force and effect, and none of the patents, trademarks and copyrights have been adjudged
invalid or unenforceable in whole or in part. The Company knows of no infringement, misappropriation or violation by others of any Intellectual
Property owned or licensed by the Company or its Subsidiaries which would reasonably be expected to have a Material Adverse Effect. Neither
the Company nor any of its Subsidiaries is a party to or bound by any options, licenses or agreements with respect to the Intellectual
Property of any other person or entity that are required to be set forth in the Prospectus and that are not described therein in all material
respects. The Company and its Subsidiaries have taken all reasonable steps necessary to secure their interests in the Intellectual Property
of the Company and its Subsidiaries from their employees and contractors and to protect the confidentiality of all of their confidential
information and trade secrets. None of the technology or intellectual property used by the Company and its Subsidiaries in its business
has been obtained or is being used by the Company or its Subsidiaries in violation of any contractual obligation binding on the Company
or its Subsidiaries, or, to the Company’s knowledge, any of its officers, directors or employees or otherwise in violation of the
rights of any persons. No third party has been granted by the Company or its Subsidiaries rights to the Intellectual Property of the Company
or its Subsidiaries, including any rights that, if exercised, could enable such party to develop products competitive to those of the
Company as described in the Registration Statement and the Prospectus. All Intellectual Property owned or exclusively licensed by the
Company or its Subsidiaries are free and clear of all liens, encumbrances, defects or other restrictions (other than non-exclusive licenses
granted in the ordinary course of business), except those that could not reasonably be expected, individually or in the aggregate, to
have a Material Adverse Effect. The Company and its Subsidiaries are not subject to any judgment, order, writ, injunction or decree of
any court or any federal, state, local, foreign or other governmental department, commission, board, bureau, agency or instrumentality,
domestic or foreign, or any arbitrator, nor has it entered into or is it a party to any agreement made in settlement of any pending or
threatened litigation, which materially restricts or impairs their use of any Intellectual Property.
(qq) The Company and each of its Subsidiaries
(i) are and have at all times been in full compliance with all laws, statutes, rules, regulations or guidance applicable to the Company
and its Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising,
labeling, promotion, sale, offer for sale, storage, import, export or disposal of any pharmaceuticals or biohazardous substances, materials
or any other products developed, manufactured or distributed by the Company (including, without limitation, from the United States Food
and Drug Administration (“FDA”), European Medicines Agency (“EMA”) and any local or
other governmental or regulatory authority performing functions similar to those performed by the FDA or EMA) (collectively, “Applicable
Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect,
(ii) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or
any other federal, state or foreign governmental authority having authority over the Company, any of its Subsidiaries or their activities
alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits
and supplements or amendments thereto required by any such Applicable Laws (collectively, the “Governmental Permits”),
(iii) have made all filings with, the appropriate local, or other governmental or regulatory agencies or bodies that are necessary for
the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Registration Statement
and the Prospectus, except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse
Effect, (iv) possess all material Governmental Permits necessary to conduct their respective businesses as described in the Registration
Statement and the Prospectus, and such Governmental Permits are valid and in full force and effect and are not in violation of any term
of any such Governmental Permits, (v) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments as required by any Applicable Laws or Governmental Permits and that all such
reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct
in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), and (vi) are not a party to
any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by
any governmental authority. All Governmental Permits are valid and in full force and effect, except where the validity or failure to be
in full force and effect would not, singularly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any Subsidiary
has received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of
any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed. Neither the
Company, any of its Subsidiaries nor, to the Company’s knowledge, any of their respective directors, officers, employees or agents
has been convicted of any crime under any Applicable Laws or has been the subject of an FDA debarment proceeding. Neither the Company
nor any of its Subsidiaries has been nor is now subject to the FDA’s Application Integrity Policy. To the Company’s knowledge,
neither the Company, any of its Subsidiaries nor any of its directors, officers, employees or agents has made, or caused the making of,
any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements
of the FDA or any other governmental authority.
(rr) There is no legal or governmental proceeding
to which the Company or any of its Subsidiaries is a party or of which any property or assets of the Company or any of its Subsidiaries
is the subject, including any proceeding before the FDA, the EMA or any foreign, local, national or other governmental agency (“Health
Regulatory Agency”) with jurisdiction over the types of products being developed by the Company that is required to be described
in the Registration Statement or the Prospectus and is not described therein, or which, singularly or in the aggregate, if determined
adversely to the Company or any of its Subsidiaries, could reasonably be expected to have a Material Adverse Effect; and no such proceedings
are threatened or contemplated by governmental or regulatory authorities or threatened by others. The Company and its Subsidiaries (i)
have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from
any governmental authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Governmental
Permits and have no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration,
action, suit, investigation or proceeding and (ii) have not received notice that any governmental authority has taken, is taking or intends
to take action to limit, suspend, modify or revoke any Governmental Permits and the Company has no knowledge that any such governmental
authority is considering such action.
(ss) The research, non-clinical pre-clinical
studies and clinical studies and tests conducted or being conducted by or on behalf of the Company or any of its Subsidiaries or in which
any of their respective product candidates have participated and, to the Company’s knowledge, the preclinical studies and clinical
trials directed or sponsored by the Company’s collaborators (collectively, the “Studies”) that are described
in, or the results of which are referred to in, the Registration Statement and the Prospectus were and, if still pending, are being conducted
with reasonable care and in all material respects in accordance with the protocols, procedures and controls pursuant to all Applicable
Laws and Governmental Permits and with standard medical and scientific research procedures; each description of the results of such Studies
is accurate and complete in all material respects and fairly presents the data derived from such Studies, and the Company and its Subsidiaries
have no knowledge of any other research, non-clinical studies or tests the results of which are inconsistent with, or otherwise call into
question, the results described or referred to in the Registration Statement and the Prospectus; the Company and its Subsidiaries have
made all such filings and obtained all such approvals as may be required by the EMA, the FDA or any committee thereof or from any other
United States or foreign government agency with jurisdiction over the types of products being developed by the Company; neither the Company
nor any of its Subsidiaries has received any notice of, or correspondence from, any governmental authority requiring the termination,
suspension or modification of any Study; and the Company and its Subsidiaries have each operated and currently are in compliance in all
material respects with all applicable rules, regulations and policies of all governmental authorities. There have been no material serious
adverse events resulting from any Study. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers
are operated in compliance in all material respects with all Applicable Laws and Governmental Permits.
(tt) The manufacture of the Company’s
products by the Company or, to the knowledge of the Company, on behalf of the Company, is being conducted in compliance with all applicable
Health Care Laws pertaining to the manufacture and post market surveillance of Drugs, Devices, and Biologics, including, without limitation,
the FDA’s current good manufacturing practice regulations pertaining to drugs (21 CFR Parts 210 and 211 et seq.), and, to the extent
applicable, the respective counterparts governing manufacturing operations promulgated by other Health Regulatory Agencies. Except as
disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether
owned by the Company or, to the knowledge of the Company, that of a third party manufacturer of the Company’s products) subject
to an FDA or other Health Regulatory Agency consent decree, seizure, import alert, or export prohibition, nor received any FDA or other
Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance
with any applicable Health Care Laws, requests to make material changes to the Company’s products, processes or operations from
the FDA or other Health Regulatory Agency, other than those that have been satisfactorily addressed and/or closed with the FDA or other
Health Regulatory Agency. To the knowledge of the Company, none of the FDA or any other Health Regulatory Agency is considering such action.
(uu) The Company acknowledges and agrees that
the Agent has informed the Company that the Agent may, to the extent permitted under the Securities Act and the Exchange Act, purchase
and sell shares of Common Stock for its own account while this Agreement is in effect; provided, that (i) no such purchase or sales
shall take place while a Placement Notice is in effect (except to the extent the Agent may engage in sales of Placement Shares purchased
or deemed purchased from the Company as a “riskless principal” or in a similar capacity) and (ii) the Company shall not be
deemed to have authorized or consented to any such purchases or sales by the Agent, except as may be otherwise agreed by the Company and
the Agent.
(vv) The Company is not a party to any agreement
with an agent or underwriter for any other “at the market” or continuous equity transaction.
(ww) The Company is not required to register
as a “broker” or “dealer” in accordance with the provisions of the Exchange Act and does not, directly or indirectly
through one or more intermediaries, control or have any other association with (within the meaning of Article I of the By-laws of FINRA)
any member firm of FINRA. No relationship, direct or indirect, exists between or among the Company, on the one hand, and the directors,
officers or shareholders of the Company, on the other hand, which is required by the rules of FINRA to be described in the Registration
Statement and the Prospectus, which is not so described. All of the information (including, but not limited to, information regarding
affiliations, security ownership and trading activity) provided to the Agent or its counsel by the Company, its officers and directors
and the holders of any securities (debt or equity) or warrants, options or rights to acquire any securities of the Company in connection
with the filing to be made and other supplemental information to be provided to FINRA pursuant to FINRA Rule 5110 in connection with the
transactions contemplated by this Agreement is true, complete and correct.
(xx) As
of the close of trading on Nasdaq on November 21, 2023, the aggregate market value of the outstanding voting and non-voting common equity
(as defined in Rule 405) of the Company held by persons other than affiliates of the Company (pursuant to Rule 144 of the Securities Act,
those that directly, or indirectly through one or more intermediaries, control, or are controlled by, or are under common control with,
the Company) (the “Non-Affiliate Shares”), was approximately $19,752,589 (calculated by multiplying (x) the
price at which the common equity of the Company was last sold on Nasdaq on October 31, 2023 by (y) the number of Non-Affiliate Shares
outstanding on November 21, 2023). The Company is not a shell company (as defined in Rule 405) and has not been a shell company for at
least 12 calendar months previously.
(yy) Neither the issuance, sale and delivery
of the Placement Shares nor the application of the proceeds thereof by the Company as described in the Registration Statement and the
Prospectus will violate Regulation T, U or X of the Board of Governors of the Federal Reserve System or any other regulation of such Board
of Governors.
(zz) Each of the independent directors (or independent
director nominees, once appointed, if applicable) named in the Registration Statement and Prospectus satisfies the independence standards
established by Nasdaq and, with respect to members of the Company’s audit committee, the enhanced independence standards contained
in Rule 10A-3(b)(1) promulgated by the Commission under the Exchange Act.
(aaa) Neither the Company nor, to the Company’s
knowledge, any of its affiliates (within the meaning of Rule 144 under the Securities Act) has, prior to the date hereof, made any offer
or sale of any securities which could be “integrated” (within the meaning of the Securities Act) with the offer and sale of
the Placement Shares hereunder.
(bbb) Neither the Company nor any of its Subsidiaries
has (i) failed to pay any dividend or sinking fund installment on preferred stock or (ii) defaulted on any installment or payment due
on indebtedness for borrowed money or on any rental on one or more long-term leases, which defaults, individually or in the aggregate,
could reasonably be expected to result in a Material Adverse Effect.
(ccc) Each financial or operational projection
or other “forward-looking statement” (as defined by Section 27A of the Securities Act or Section 21E of the Exchange Act)
contained in the Registration Statement or the Prospectus (i) was so included by the Company in good faith and with reasonable basis after
due consideration by the Company of the underlying assumptions, estimates and other applicable facts and circumstances and (ii) as required,
is accompanied by meaningful cautionary statements identifying those factors that could cause actual results to differ materially from
those in such forward-looking statement. No such statement was made with the knowledge of a director or senior manager of the Company
that was false or misleading.
(ddd) There are no relationships, direct or
indirect, or related party transactions involving the Company or any of its Subsidiaries or any other person (including any director,
officer, stockholder, customer or supplier of the Company or any of its Subsidiaries) required to be described in the Registration Statement
or the Prospectus that have not been described as required. There are no material outstanding loans, advances (except normal advances
for business expenses in the ordinary course of business) or guarantees of indebtedness by the Company or any of its Subsidiaries to or
for the benefit of any of the officers or directors of the Company or any of its Subsidiaries, or any of the family members of any of
such persons.
(eee) The Company is not in or subject to a
bankruptcy or insolvency proceeding in any jurisdiction.
(fff) The Company and its Subsidiaries (i) are
in compliance, in all material respects, with any and all applicable foreign, federal, state and local laws, rules, regulations, treaties,
statutes and codes promulgated by any and all governmental authorities (including pursuant to the Occupational Health and Safety Act)
relating to the protection of human health and safety the workplace (“Occupational Laws”); (ii) have received
all material permits, licenses or other approvals required of it under applicable Occupational Laws to conduct their respective businesses
as currently conducted; and (iii) are in compliance, in all material respects, with all terms and conditions of such permit, license or
approval. No action, proceeding, revocation proceeding, writ, injunction or claim is pending or, to the Company’s knowledge, threatened
against the Company or any of its Subsidiaries relating to Occupational Laws, and the Company does not have knowledge of any facts, circumstances
or developments relating to its operations or cost accounting practices that could reasonably be expected to form the basis for or give
rise to such actions, suits, investigations or proceedings.
(ggg) No director or officer of the Company
or any of its Subsidiaries is subject to any non-competition agreement or non-solicitation agreement with any employer or prior employer
which could materially affect each director’s or officer’s ability to be and act in the capacity of a director or officer
of the Company or a Subsidiary.
(hhh) The Company has duly and properly filed
or caused to be filed with the U.S. Patent and Trademark Office (the “PTO”) and applicable foreign and international
patent and trademark authorities all patents, trademarks, copyrights and applications relating to the same owned by the Company and its
Subsidiaries (the “Company Patent and Trademark Applications”). To the knowledge of the Company, the Company
has complied with the PTO’s duty of candor and disclosure for the Company Patent and Trademark Applications and has made no material
misrepresentation in the Company Patent and Trademark Applications. To the Company’s knowledge, the Company Patent and Trademark
Applications disclose patentable subject matter. The Company has not been notified of any inventorship challenges nor has any interference
been declared or provoked nor is any material fact known by the Company that would preclude the issuance of patents with respect to the
Company Patent and Trademark Applications or would render such patents, if issued, invalid or unenforceable. Except as would not have
a Material Adverse Effect, neither the Company nor any of its Subsidiaries has breached and is currently in breach of any provision of
any license, contract or other agreement governing the use by the Company or its Subsidiaries of Intellectual Property owned by third
parties (collectively, the “Licenses”) and no third party has alleged any such breach and the Company is unaware
of any facts that would form a reasonable basis for such a claim. To the Company’s knowledge, no other party to the Licenses has
breached or is currently in breach of any provision of the Licenses. Each of the Licenses is in full force and effect and constitutes
a valid and binding agreement between the parties thereto, enforceable in accordance with its terms, and there has not occurred any breach
or default under any such Licenses or any event that, with the giving of notice or lapse of time, would constitute a breach or default
thereunder. Except as would not have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has been and is currently
involved in any disputes regarding the Licenses. To the Company’s knowledge, all patents licensed to the Company pursuant to the
Licenses are valid, enforceable and being duly maintained. To the Company’s knowledge, all patent applications licensed to the Company
pursuant to the Licenses are being duly prosecuted.
Any certificate signed by any officer of the Company
and delivered to the Agent or its counsel in connection with the offering of the Placement Shares shall be deemed a representation and
warranty by the Company, as to matters covered thereby, to the Agent.
7. Covenants
of the Company. The Company covenants and agrees with the Agent that:
(a) Registration
Statement Amendments. After the date of this Agreement and during any period in which the Prospectus relating to any Placement Shares
is required to be delivered by the Agent under the Securities Act (including in circumstances where such requirement may be satisfied
pursuant to Rule 172 under the Securities Act or a similar rule); (i) the Company will notify the Agent promptly of the time when any
subsequent amendment to the Registration Statement, other than Incorporated Documents, has been filed with the Commission and/or has become
effective or any subsequent supplement to the Prospectus, other than Incorporated Documents, has been filed and of any request by the
Commission for any amendment or supplement to the Registration Statement or Prospectus or for additional information; (ii) the Company
will prepare and file with the Commission, promptly upon the Agent’s request, any amendments or supplements to the Registration
Statement or Prospectus that, in the Agent’s reasonable opinion, may be necessary or advisable in connection with the distribution
of the Placement Shares by the Agent (provided, however, that the failure of the Agent to make such request shall not relieve the Company
of any obligation or liability hereunder, or affect the Agent’s right to rely on the representations and warranties made by the
Company in this Agreement and provided, further, that the only remedy the Agent shall have with respect to the failure by the Company
to make such filing (but without limiting the Agent’s rights under Section 9 hereof) will be to cease making sales under this Agreement
until such amendment or supplement is filed); (iii) the Company will not file any amendment or supplement to the Registration Statement
or Prospectus, other than Incorporated Documents, relating to the Placement Shares or a security convertible into or exchangeable or exercisable
for the Placement Shares unless a copy thereof has been submitted to the Agent within a reasonable period of time before the filing and
the Agent has not reasonably objected thereto (provided, however, that the failure of the Agent to make such objection shall not relieve
the Company of any obligation or liability hereunder, or affect the Agent’s right to rely on the representations and warranties
made by the Company in this Agreement and provided, further, that the only remedy the Agent shall have with respect to the Company’s
making such filing notwithstanding the Agent’s objection (but without limiting the Agent’s rights under Section 9 hereof)
will be to cease making sales under this Agreement) and the Company will furnish to the Agent at the time of filing thereof a copy of
any Incorporated Document, except for those documents available via EDGAR; and (iv) the Company will cause each amendment or supplement
to the Prospectus, other than Incorporated Documents, to be filed with the Commission as required pursuant to the applicable paragraph
of Rule 424(b) of the Securities Act and, in the case of any Incorporated Document, to be filed with the Commission as required pursuant
to the Exchange Act, within the time period prescribed.
(b) Notice
of Commission Stop Orders. The Company will advise the Agent, promptly after it receives notice or obtains knowledge thereof, of the
issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement, of the
suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction or of the initiation or threatening of
any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent the issuance of any stop
order or to obtain its withdrawal if such a stop order should be issued. The Company will advise the Agent promptly after it receives
any request by the Commission for any amendments to the Registration Statement or any amendment or supplements to the Prospectus or for
additional information related to the offering of the Placement Shares or for additional information related to the Registration Statement
or the Prospectus.
(c) Delivery
of Prospectus; Subsequent Changes. During any period in which the Prospectus relating to the Placement Shares is required to be delivered
by the Agent under the Securities Act with respect to the offer and sale of the Placement Shares (including in circumstances where such
requirement may be satisfied pursuant to Rule 172 under the Securities Act or a similar rule), the Company will comply with all requirements
imposed upon it by the Securities Act, as from time to time in force, and will file on or before their respective due dates (taking into
account any extensions available under the Exchange Act) all reports and any definitive proxy or information statements required to be
filed by the Company with the Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other provision of or under the Exchange
Act. If during such period any event occurs as a result of which the Prospectus as then amended or supplemented would include an untrue
statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances
then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration Statement or Prospectus
to comply with the Securities Act, the Company will promptly notify the Agent to suspend the offering of Placement Shares during such
period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of the Company) so as
to correct such statement or omission or effect such compliance. If the Company has omitted any information from the Registration Statement
pursuant to Rule 430B under the Securities Act, it will use its best efforts to comply with the provisions thereof and make all requisite
filings with the Commission pursuant to said Rule 430B and to notify the Agent promptly of all such filings if not available on EDGAR.
(d) Listing
of Placement Shares. During any period in which the Prospectus relating to the Placement Shares is required to be delivered by the
Agent under the Securities Act with respect to the offer and sale of the Placement Shares (including in circumstances where such requirement
may be satisfied pursuant to Rule 172 under the Securities Act or a similar rule), the Company will use its commercially reasonable efforts
to cause the Placement Shares to be listed on Nasdaq. The Company will timely file with Nasdaq all material documents and notices required
by Nasdaq of companies that have or will issue securities that are traded on Nasdaq.
(e) Delivery
of Registration Statement and Prospectus. The Company will furnish to the Agent and its counsel (at the expense of the Company) copies
of the Registration Statement, the Prospectus (including all Incorporated Documents) and all amendments and supplements to the Registration
Statement or Prospectus that are filed with the Commission during any period in which the Prospectus relating to the Placement Shares
is required to be delivered under the Securities Act (including all Incorporated Documents filed with the Commission during such period),
in each case as soon as reasonably practicable and in such quantities as the Agent may from time to time reasonably request and, at the
Agent’s request, will also furnish copies of the Prospectus to each exchange or market on which sales of the Placement Shares may
be made; provided, however, that the Company shall not be required to furnish any document (other than the Prospectus) to
the Agent to the extent such document is available on EDGAR.
(f) Earnings
Statement. The Company will make generally available to its security holders and to the Agent as soon as practicable, but in any event
not later than 15 months after the end of the Company’s current fiscal quarter, an earnings statement covering a 12-month period
that satisfies the provisions of Section 11(a) of and Rule 158 under the Securities Act.
(g) Expenses.
The Company, whether or not the transactions contemplated hereunder are consummated or this Agreement is terminated in accordance with
the provisions of Section 11 hereunder, will pay all expenses incident to the performance of its obligations hereunder, including expenses
relating to (i) the preparation, printing and filing of the Registration Statement and each amendment and supplement thereto, of the Prospectus
and of each amendment and supplement thereto and of this Agreement and such other documents as may be required in connection with the
offering, purchase, sale, issuance or delivery of the Placement Shares, (ii) the preparation, issuance, sale and delivery of the Placement
Shares and any taxes due or payable in connection therewith, (iii) the qualification of the Placement Shares under securities laws in
accordance with the provisions of Section 7(w) of this Agreement, including filing fees (provided, however, that any fees or disbursements
of counsel for the Agent in connection therewith shall be paid by the Agent except as set forth in clauses (vii) and (viii) below), (iv)
the printing and delivery to the Agent and its counsel of copies of the Prospectus and any amendments or supplements thereto, and of this
Agreement, (v) the fees and expenses incurred in connection with the listing or qualification of the Placement Shares for trading on Nasdaq,
(vi) the filing fees and expenses, if any, owed to the Commission or FINRA and the fees and expenses of any transfer agent or registrar
for the Shares, (vii) the fees and associated expenses of the Agent’s outside legal counsel for filings with the FINRA Corporate
Financing Department in an amount not to exceed $15,000 (excluding FINRA filing fees referred to in clause (vi) above and in addition
to the fees and disbursements referred to in clause (viii) below), and (viii) the reasonable fees and disbursements of the Agent’s
outside legal counsel (A) in an amount not to exceed $75,000 arising out of executing this Agreement and the Company’s delivery
of the initial certificate pursuant to Section 7(m) and (B) in an amount not to exceed $15,000 in connection with each Representation
Date (as defined below) on which the Company is required to provide a certificate pursuant to Section 7(m) (in addition to the fees and
associated expenses referred to in clause (vii) above).
(h) Use
of Proceeds. The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use of Proceeds.”
(i) Notice
of Other Sales. Without the prior written consent of the Agent, the Company will not, directly or indirectly, offer to sell, sell,
contract to sell, grant any option to sell or otherwise dispose of any shares of Common Stock (other than the Placement Shares offered
pursuant to this Agreement) or securities convertible into or exchangeable or exercisable for shares of Common Stock, warrants or any
rights to purchase or acquire shares of Common Stock during the period beginning on the fifth Trading Day immediately prior to the date
on which any Placement Notice is delivered to Agent hereunder and ending on the second Trading Day immediately following the final Settlement
Date with respect to Placement Shares sold pursuant to such Placement Notice (or, if the Placement Notice has been terminated or suspended
prior to the sale of all Placement Shares covered by a Placement Notice, the date of such suspension or termination); and will not directly
or indirectly in any other “at the market offering” or continuous equity transaction offer to sell, sell, contract to sell,
grant any option to sell or otherwise dispose of any shares of Common Stock (other than the Placement Shares offered pursuant to this
Agreement) or securities convertible into or exchangeable or exercisable for shares of Common Stock, warrants or any rights to purchase
or acquire, shares of Common Stock prior to the later of the termination of this Agreement and the sixtieth day immediately following
the final Settlement Date with respect to Placement Shares sold pursuant to such Placement Notice; provided, however, that
such restrictions will not be required in connection with the Company’s issuance or sale of (i) shares of Common Stock, options
to purchase shares of Common Stock, other securities under the Company’s existing equity incentive plans, or shares of Common Stock
issuable upon the exercise of options or vesting of other securities, pursuant to any employee or director stock option or benefits plan,
stock ownership plan or dividend reinvestment plan (but not shares of Common Stock subject to a waiver to exceed plan limits in its dividend
reinvestment plan) of the Company whether now in effect or hereafter implemented, (ii) shares of Common Stock issuable upon conversion
of securities or the exercise of warrants, options or other rights in effect or outstanding, and disclosed in filings by the Company available
on EDGAR or otherwise in writing to the Agent and (iii) shares of Common Stock or securities convertible into or exchangeable for
shares of Common Stock as consideration for mergers, acquisitions, other business combinations or strategic alliances occurring after
the date of this Agreement which are not issued for capital raising purposes.
(j) Change
of Circumstances. The Company will, at any time during a fiscal quarter in which the Company intends to tender a Placement Notice
or sell Placement Shares, advise the Agent promptly after it shall have received notice or obtained knowledge of any information or fact
that would alter or affect in any material respect any opinion, certificate, letter or other document provided or required to be provided
to the Agent pursuant to this Agreement.
(k) Due
Diligence Cooperation. During the term of this Agreement, the Company will cooperate with any reasonable due diligence review conducted
by the Agent, its affiliates agents and counsel from time to time in connection with the transactions contemplated hereby, including providing
information and making available documents and senior corporate officers, during regular business hours and at the Company’s principal
offices, as the Agent may reasonably request.
(l) Required
Filings Relating to Placement of Placement Shares. The Company agrees that on or prior to such dates as the Securities Act shall require,
the Company will (i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under the Securities
Act, which prospectus supplement will set forth, within the relevant period, the number or amount of Placement Shares sold through or
to the Agent, the Net Proceeds to the Company and the compensation payable by the Company to the Agent with respect to such Placement
Shares, and (ii) deliver such number of copies of each such prospectus supplement to each exchange or market on which such sales were
effected as may be required by the rules or regulations of such exchange or market; provided, that, unless a prospectus supplement
containing such information is required to be filed under the Securities Act, the requirement of this Section 7(l) may be satisfied by
Company’s inclusion in the Company’s Form 10-K or Form 10-Q, as applicable, of the number or amount of Placement Shares sold
through or to the Agent, the Net Proceeds to the Company and the compensation payable by the Company to the Agent with respect to such
Placement Shares during the relevant period.
(m) Representation
Dates; Certificate. On or prior to the date on which the Company first delivers a Placement Notice pursuant to this agreement (the
“First Placement Notice Date”) and each time the Company:
(i) amends
or supplements the Registration Statement or the Prospectus relating to the Placement Shares (other than a prospectus supplement filed
in accordance with Section 7(l) of this Agreement) by means of a post-effective amendment, sticker or supplement but not by means of incorporation
of document(s) by reference into the Registration Statement or the Prospectus relating to the Placement Shares;
(ii) files
an annual report on Form 10-K under the Exchange Act (including any Form 10-K/A containing amended financial information or a material
amendment to the previously filed Form 10-K);
(iii) files
a quarterly report on Form 10-Q under the Exchange Act; or
(iv) files a current report on Form 8-K
containing amended financial information (other than an earnings release that is “furnished” pursuant to Item 2.02 or
Item 7.01 of Form 8-K) under the Exchange Act (each date of filing of one or more of the documents referred to in clauses (i)
through (iv) shall be a “Representation Date”), the Company shall furnish the Agent (but in the case of
clause (iv) above only if (1) a Placement Notice is pending or in effect and (2) the Agent requests such certificate within three
Business Days after the filing of such Form 8-K with the Commission) with a certificate, in the form attached hereto as Exhibit
7(m) (modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented),
within two Trading Days of any Representation Date. The requirement to provide a certificate under this Section 7(m) shall be waived
for any Representation Date occurring at a time at which no Placement Notice is pending or in effect, which waiver shall continue
until the earlier to occur of (1) the date the Company delivers a Placement Notice hereunder (which for such calendar quarter shall
be considered a Representation Date) and (2) the next occurring Representation Date. Notwithstanding the foregoing, if the Company
subsequently decides to sell Placement Shares following a Representation Date on which the Company relied on the waiver referred to
in the previous sentence and did not provide the Agent with a certificate under this Section 7(m), then before the Company delivers
a Placement Notice or the Agent sells any Placement Shares pursuant thereto, the Company shall provide the Agent with a certificate,
in the form attached hereto as Exhibit 7(m), dated the date of such Placement Notice. Within two Trading Days of
each Representation Date, the Company shall have furnished to the Agent such further information, certificates and documents as the
Agent may reasonably request.
(n) Legal
Opinions. On or prior to the First Placement Notice Date and on any date which the Company is obligated to deliver a certificate pursuant
to Section 7(m) for which no waiver is applicable, the Company shall cause to be furnished to the Agent the written opinion and negative
assurance letter of Lucosky Brookman LLP, counsel to the Company, or such other counsel satisfactory to the Agent (“Company
Counsel”), in form and substance satisfactory to the Agent and its counsel, dated the date that the opinion and negative
assurance letter are required to be delivered, modified, as necessary, to relate to the Registration Statement and the Prospectus as then
amended or supplemented; provided, however, that in lieu of such opinion and negative assurance letter for subsequent Representation
Dates, Company Counsel may furnish the Agent with a letter to the effect that the Agent may rely on a prior opinion or negative assurance
letter delivered by such counsel under this Section 7(n) to the same extent as if it were dated the date of such letter (except that statements
in such prior opinion or negative assurance letter shall be deemed to relate to the Registration Statement and the Prospectus as amended
or supplemented at such Representation Date).
(o) Intellectual
Property Opinion. On or prior to the First Placement Notice Date and on any date which the Company is obligated to deliver a certificate
pursuant to Section 7(m) for which no waiver is applicable, the Company shall cause to be furnished to the Agent the written opinion of
Schmeiser Olsen & Watts LLP, counsel for the Company with respect to intellectual property matters, or such other intellectual property
counsel satisfactory to the Agent (“Intellectual Property Counsel”), in form and substance satisfactory to the
Agent and its counsel, dated the date that the opinion letter is required to be delivered, modified, as necessary, to relate to the Registration
Statement and the Prospectus as then amended or supplemented; provided, however, that in lieu of such written opinion for
subsequent Representation Dates, Intellectual Property Counsel may furnish the Agent with a letter to the effect that the Agent may rely
on a prior opinion letter delivered by such counsel under this Section 7(o) to the same extent as if it were dated the date of such opinion
letter (except that statements in such prior opinion letter shall be deemed to relate to the Registration Statement and the Prospectus
as amended or supplemented at such Representation Date).
(p) Comfort
Letter. On or prior to the First Placement Notice Date and on any date which the Company is obligated to deliver a certificate pursuant
to Section 7(m) for which no waiver is applicable, the Company shall cause its independent registered public accounting firm (and any
other independent accountants whose report is included in the Registration Statement or the Prospectus) to furnish the Agent letters (the
“Comfort Letters”), dated the date the Comfort Letter is delivered, which shall meet the requirements set forth
in this Section 7(p); provided, that if requested by the Agent, the Company shall cause a Comfort Letter to be furnished to the
Agent within 10 Trading Days of the occurrence of any material transaction or event that necessitates the filing of additional, pro forma,
amended or revised financial statements (including any restatement of previously issued financial statements). Each Comfort Letter shall
be in form and substance satisfactory to the Agent and each Comfort Letter from the Company’s independent registered public accounting
firm shall (i) confirm that they are an independent registered public accounting firm within the meaning of the Securities Act and the
PCAOB, (ii) state, as of such date, the conclusions and findings of such firm with respect to the financial information and other matters
ordinarily covered by accountants’ “comfort letters” to underwriters in connection with registered public offerings
(the first such letter, the “Initial Comfort Letter”) and (iii) update the Initial Comfort Letter with any information
that would have been included in the Initial Comfort Letter had it been given on such date and modified as necessary to relate to the
Registration Statement and the Prospectus, as amended and supplemented to the date of such letter.
(q) Market
Activities. The Company will not, directly or indirectly, and will cause its officers, directors and Subsidiaries not to (i) take
any action designed to cause or result in, or that constitutes or might reasonably be expected to constitute, the stabilization or manipulation
of the price of any security of the Company to facilitate the sale or resale of shares of Common Stock or (ii) sell, bid for, or purchase
shares of Common Stock in violation of Regulation M, or pay anyone any compensation for soliciting purchases of the Placement Shares other
than the Agent; provided, however, that the Company may bid for and purchase shares of Common Stock in accordance with Rule
10b-18 under the Exchange Act.
(r) Insurance.
The Company and its Subsidiaries shall maintain, or cause to be maintained, insurance in such amounts and covering such risks as is reasonable
and customary for the business for which it is engaged.
(s) Compliance
with Laws. The Company and each of its Subsidiaries shall maintain, or cause to be maintained, all material environmental certificates,
authorizations or permits required by federal, state and local law in order to conduct their businesses as described in the Prospectus
(collectively, “Permits”), and the Company and each of its Subsidiaries shall conduct their businesses, or cause their
businesses to be conducted, in substantial compliance with such Permits and with applicable Environmental Laws, except where the failure
to maintain or be in compliance with such Permits could not reasonably be expected to result in a Material Adverse Effect.
(t) Investment
Company Act. The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it nor any of its Subsidiaries
will be or become, at any time prior to the termination of this Agreement, an “investment company,” as such term is defined
in the Investment Company Act.
(u) Securities
Act and Exchange Act. The Company will use its best efforts to comply with all requirements imposed upon it by the Securities Act
and the Exchange Act as from time to time in force, so far as necessary to permit the sales of, or dealings in, the Placement Shares as
contemplated by the provisions hereof and the Prospectus.
(v) No
Offer to Sell. Other than a free writing prospectus (as defined in Rule 405 under the Securities Act) approved in advance by the Company
and the Agent, neither the Agent nor the Company (including its agents and representatives, other than the Agent in its capacity as agent)
will make, use, prepare, authorize, approve or refer to any written communication (as defined in Rule 405 under the Securities Act), required
to be filed with the Commission, that constitutes an offer to sell or solicitation of an offer to buy Placement Shares hereunder.
(w) Blue
Sky and Other Qualifications. The Company will use its commercially reasonable efforts, in cooperation with the Agent, to qualify
the Placement Shares for offering and sale, or to obtain an exemption for the Placement Shares to be offered and sold, under the applicable
securities laws of such states and other jurisdictions (domestic or foreign) as the Agent may designate and to maintain such qualifications
and exemptions in effect for so long as required for the distribution of the Placement Shares (but in no event for less than one year
from the date of this Agreement); provided, however, that the Company shall not be obligated to file any general consent to service
of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or
to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject. In each jurisdiction
in which the Placement Shares have been so qualified or exempt, the Company will file such statements and reports as may be required by
the laws of such jurisdiction to continue such qualification or exemption, as the case may be, in effect for so long as required for the
distribution of the Placement Shares (but in no event for less than one year from the date of this Agreement).
(x) Sarbanes-Oxley
Act. The Company will maintain and keep accurate books and records reflecting its assets and maintain internal accounting controls
in a manner designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with GAAP and including those policies and procedures that (i) pertain to the maintenance
of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company, (ii)
provide reasonable assurance that transactions are recorded as necessary to permit the preparation of the Company’s financial statements
in accordance with GAAP, (iii) that receipts and expenditures of the Company are being made only in accordance with management’s
and the Company’s directors’ authorization, and (iv) provide reasonable assurance regarding prevention or timely detection
of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on its financial statements.
The Company will maintain such controls and other procedures, including, without limitation, those required by Sections 302 and 906 of
the Sarbanes-Oxley Act, and the applicable regulations thereunder that are designed to ensure that information required to be disclosed
by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within
the time periods specified in the Commission’s rules and forms, including, without limitation, controls and procedures designed
to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated
and communicated to the Company’s management, including its principal executive officer and principal financial officer, or persons
performing similar functions, as appropriate to allow timely decisions regarding required disclosure and to ensure that material information
relating to the Company is made known to it by others within the Company, particularly during the period in which such periodic reports
are being prepared.
(y) Emerging
Growth Company. The Company will promptly notify the Agent if the company ceases to be an Emerging Growth Company at any time prior
to the completion of the Agent’s distribution of the Placement Shares pursuant to this Agreement.
(z) Renewal
of Registration Statement. If, immediately prior to the third anniversary of the initial effective date of the Registration Statement
(the “Renewal Date”), any of the Placement Shares remain unsold and this Agreement has not been terminated,
the Company will, prior to the Renewal Date, file a new shelf registration statement or, if applicable, an automatic shelf registration
statement relating to the Common Stock that may be offered and sold pursuant to this Agreement (which shall include a prospectus reflecting
the number or amount of Placement Shares that may be offered and sold pursuant to this Agreement), in a form satisfactory to the Agent
and its counsel, and, if such registration statement is not an automatic shelf registration statement, will use its best efforts to cause
such registration statement to be declared effective within 180 days after the Renewal Date. The Company will take all other reasonable
actions necessary or appropriate to permit the public offer and sale of the Placement Shares to continue as contemplated in the expired
registration statement and this Agreement. From and after the effective date thereof, references herein to the “Registration Statement”
shall include such new shelf registration statement or such new automatic shelf registration statement, as the case may be.
(aa) General Instruction I.B.1. of Form S-3.
If, from and after the date of this Agreement, the Company becomes eligible to use Form S-3 pursuant to General Instruction I.B.1. and
files a new prospectus supplement, and at such later date is no longer eligible to use Form S-3 pursuant to General Instruction I.B.1.
at the time it files with the Commission an annual report on Form 10-K or any post-effective amendment to the Registration Statement,
then it shall promptly notify the Agent and, within two Business Days after the date of filing of such annual report on Form 10-K or amendment
to the Registration Statement, the Company shall file a new prospectus supplement with the Commission reflecting the number of shares
of Common Stock available to be offered and sold by the Company under this Agreement pursuant to General Instruction I.B.6. of Form S-3;
provided, however, that the Company may delay the filing of any such prospectus supplement for up to 30 days if, in the
reasonable judgment of the Company, it is in the best interest of the Company to do so, provided that no Placement Notice is in effect
or pending during such time. Until such time as the Company shall have corrected such misstatement or omission or effected such compliance,
the Company shall not notify the Agent to resume the offering of Placement Shares.
(bb) Tax Indemnity. The Company will
indemnify and hold harmless the Agent against any documentary, stamp or similar issue tax, including any interest and penalties, on the
issue and sale of the Placement Shares.
(cc) Transfer Agent. The Company has
engaged and will maintain, at its sole expense, a transfer agent and registrar for the Common Stock.
8. Conditions
to the Agent’s Obligations. The obligations of the Agent hereunder with respect to a Placement will be subject to the continuing
accuracy and completeness of the representations and warranties made by the Company herein, to the due performance by the Company of its
obligations hereunder, to the completion by the Agent of a due diligence review satisfactory to the Agent in its reasonable judgment,
and to the continuing satisfaction (or waiver by the Agent in its sole discretion) of the following additional conditions:
(a) Registration
Statement Effective. The Registration Statement shall be effective and shall be available for all offers and sales of Placement Shares
(i) that have been issued pursuant to all prior Placement Notices and (ii) that will be issued pursuant to any Placement Notice.
(b) Prospectus
Supplement. The Company shall have filed with the Commission the Prospectus Supplement pursuant to Rule 424(b) under the Securities
Act not later than the Commission’s close of business on the second Business Day following the date of this Agreement.
(c) No
Material Notices. None of the following events shall have occurred and be continuing: (i) receipt by the Company or any of its Subsidiaries
of any request for additional information from the Commission or any other federal or state governmental authority during the period of
effectiveness of the Registration Statement, the response to which would require any post-effective amendments or supplements to the Registration
Statement or the Prospectus; (ii) the issuance by the Commission or any other federal or state governmental authority of any stop order
suspending the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt by the
Company or any of its Subsidiaries of any notification with respect to the suspension of the qualification or exemption from qualification
of any of the Placement Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (iv)
the occurrence of any event that makes any material statement made in the Registration Statement or the Prospectus or any material Incorporated
Document untrue in any material respect or that requires the making of any changes in the Registration Statement, the Prospectus or Incorporated
Documents so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or omit to state
any material fact required to be stated therein or necessary to make the statements therein not misleading and, in the case of the Prospectus,
so that it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or
necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.
(d) No
Misstatement or Material Omission. The Agent shall not have advised the Company that the Registration Statement or Prospectus, or
any amendment or supplement thereto, contains an untrue statement of fact that in the Agent’s opinion is material, or omits to state
a fact that in the Agent’s opinion is material and is required to be stated therein or is necessary to make the statements therein
not misleading.
(e) Material
Changes. Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission, there shall
not have been any material adverse change, on a consolidated basis, in the authorized capital stock of the Company or any Material Adverse
Effect or any development that could reasonably be expected to result in a Material Adverse Effect, or any downgrading in or withdrawal
of the rating assigned to any of the Company’s securities (other than asset backed securities), if any, by any rating organization
or a public announcement by any rating organization that it has under surveillance or review its rating of any of the Company’s
securities (other than asset backed securities), if any, the effect of which, in the judgment of the Agent (without relieving the Company
of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering
of the Placement Shares on the terms and in the manner contemplated in the Prospectus.
(f) Company
Counsel Legal Opinions. The Agent shall have received the opinions and negative assurance letters, as applicable, of Company Counsel
and Intellectual Property Counsel required to be delivered pursuant to Section 7(n) and Section 7(o), as applicable, on or before the
date on which such delivery of such opinions and negative assurance letters are required pursuant to Section 7(n) and Section 7(o),
as applicable.
(g) Agent’s
Counsel Legal Opinion. The Agent shall have received from Duane Morris LLP, counsel for the Agent, such opinion or opinions, on or
before the date on which the delivery of the Company Counsel legal opinion is required pursuant to Section 7(n), with respect to such
matters as the Agent may reasonably require, and the Company shall have furnished to such counsel such documents as they may request to
enable them to pass upon such matters.
(h) Comfort
Letter. The Agent shall have received the Comfort Letter required to be delivered pursuant to Section 7(p) on or before the date on
which such delivery of such Comfort Letter is required pursuant to Section 7(p).
(i) Representation
Certificate. The Agent shall have received the certificate required to be delivered pursuant to Section 7(m) on or before the date
on which delivery of such certificate is required pursuant to Section 7(m).
(j) Secretary’s
Certificate. On or prior to the First Placement Notice Date, the Agent shall have received a certificate, signed on behalf of the
Company by the Secretary of the Company and attested to by an executive officer of the Company, dated as of such date and in form and
substance satisfactory to the Agent and its counsel, certifying as to (i) the amended and restated certificate of incorporation of the
Company, (ii) the amended and restated bylaws of the Company, (iii) the resolutions of the board of directors of the Company or duly authorized
committee thereof authorizing the execution, delivery and performance of this Agreement and the issuance and sale of the Placement Shares
and (iv) the incumbency of the officers of the Company duly authorized to execute this Agreement and the other documents contemplated
by this Agreement (including each of the officers set forth on Schedule 2).
(k) No
Suspension. The Common Stock shall be duly listed, and admitted and authorized for trading, subject to official notice of issuance,
on Nasdaq. Trading in the Common Stock shall not have been suspended on, and the Common Stock shall not have been delisted from, Nasdaq.
(l) Other
Materials. On each date on which the Company is required to deliver a certificate pursuant to Section 7(m), the Company shall have
furnished to the Agent such appropriate further information, opinions, certificates, letters and other documents as the Agent may have
reasonably requested. All such information, opinions, certificates, letters and other documents shall have been in compliance with the
provisions hereof. The Company shall have furnished the Agent with conformed copies of such opinions, certificates, letters and other
documents as the Agent may have reasonably requested.
(m) Securities
Act Filings Made. All filings with the Commission required by Rule 424(b) or Rule 433 under the Securities Act to have been filed
prior to the issuance of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing
by Rule 424(b) (without reliance on Rule 424(b)(8) of the Securities Act) or Rule 433, as applicable.
(n) Approval
for Listing. Either (i) the Placement Shares shall have been approved for listing on Nasdaq, subject only to notice of issuance, or
(ii) the Company shall have filed an application for listing of the Placement Shares on Nasdaq at, or prior to, the First Placement Notice
Date and Nasdaq shall have reviewed such application and not provided any objections thereto.
(o) FINRA.
FINRA shall have raised no objection to the terms of the offering contemplated hereby and the amount of compensation allowable or payable
to the Agent as described in the Prospectus.
(p) No
Termination Event. There shall not have occurred any event that would permit the Agent to terminate this Agreement pursuant to Section
11(a).
9. Indemnification
and Contribution.
(a) Company
Indemnification. The Company agrees to indemnify and hold harmless the Agent, its affiliates and their respective partners, members,
directors, officers, employees and agents, and each person, if any, who (i) controls the Agent within the meaning of Section 15 of the
Securities Act or Section 20 of the Exchange Act or (ii) is controlled by or is under common control with the Agent, in each case from
and against any and all losses, claims, liabilities, expenses and damages (including any and all investigative, legal and other expenses
reasonably incurred in connection with, and any and all amounts paid in settlement (in accordance with this Section 9), any action, suit,
investigation or proceeding between any of the indemnified parties and any indemnifying parties or between any indemnified party and any
third party (including any governmental or self-regulatory authority, or otherwise, or any claim asserted or threatened), as and when
incurred, to which the Agent, or any such other person may become subject under the Securities Act, the Exchange Act or other federal
or state statutory law or regulation, at common law or otherwise, insofar as such losses, claims, liabilities, expenses or damages arise
out of or are based, directly or indirectly, on (x) any untrue statement or alleged untrue statement of a material fact contained
in the Registration Statement or the Prospectus (or any amendment or supplement to the Registration Statement or the Prospectus) or in
any free writing prospectus or in any application or other document executed by or on behalf of the Company or based on written information
furnished by or on behalf of the Company filed in any jurisdiction in order to qualify the Common Stock under the securities laws thereof
or filed with the Commission, (y) the omission or alleged omission to state in any such document a material fact required to be stated
therein or necessary to make the statements therein (solely with respect to the Prospectus, in light of the circumstances under which
they were made) not misleading or (z) any breach by any of the indemnifying parties of any of their respective representations, warranties
or agreements contained in this Agreement; provided, however, that this indemnity agreement shall not apply to the extent
that such loss, claim, liability, expense or damage arises from the sale of the Placement Shares pursuant to this Agreement and is caused,
directly or indirectly, by an untrue statement or omission, or alleged untrue statement or omission, made in reliance upon and in conformity
with the Agent’s Information. This indemnity agreement will be in addition to any liability that the Company might otherwise have.
(b) Agent
Indemnification. The Agent agrees to indemnify and hold harmless the Company and its directors and each officer of the Company who
signed the Registration Statement, and each person, if any, who (i) controls the Company within the meaning of Section 15 of the
Securities Act or Section 20 of the Exchange Act or (ii) is controlled by or is under common control with the Company against any and
all loss, liability, claim, damage and expense described in the indemnity contained in Section 9(a), as incurred, but only with respect
to untrue statements or omissions, or alleged untrue statements or omissions, made in the Registration Statement (or any amendments thereto)
or the Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with the Agent’s Information.
(c) Procedure.
Any party that proposes to assert the right to be indemnified under this Section 9 will, promptly after receipt of notice of commencement
of any action against such party in respect of which a claim is to be made against an indemnifying party or parties under this Section
9, notify each such indemnifying party of the commencement of such action, enclosing a copy of all papers served, but the omission so
to notify such indemnifying party will not relieve the indemnifying party from (i) any liability that it might have to any indemnified
party otherwise than under this Section 9 and (ii) any liability that it may have to any indemnified party under the foregoing provision
of this Section 9 unless, and only to the extent that, such omission results in the forfeiture of substantive rights or defenses by the
indemnifying party. If any such action is brought against any indemnified party and it notifies the indemnifying party of its commencement,
the indemnifying party will be entitled to participate in and, to the extent that it elects by delivering written notice to the indemnified
party promptly after receiving notice of the commencement of the action from the indemnified party, jointly with any other indemnifying
party similarly notified, to assume the defense of the action, with counsel reasonably satisfactory to the indemnified party, and after
notice from the indemnifying party to the indemnified party of its election to assume the defense, the indemnifying party will not be
liable to the indemnified party for any other legal expenses except as provided below and except for the reasonable costs of investigation
subsequently incurred by the indemnified party in connection with the defense. The indemnified party will have the right to employ its
own counsel in any such action, but the fees, expenses and other charges of such counsel will be at the expense of such indemnified party
unless (1) the employment of counsel by the indemnified party has been authorized in writing by the indemnifying party, (2) the indemnified
party has reasonably concluded (based on advice of counsel) that there may be legal defenses available to it or other indemnified parties
that are different from or in addition to those available to the indemnifying party, (3) a conflict or potential conflict exists (based
on advice of counsel to the indemnified party) between the indemnified party and the indemnifying party (in which case the indemnifying
party will not have the right to direct the defense of such action on behalf of the indemnified party) or (4) the indemnifying party has
not in fact employed counsel reasonably satisfactory to the indemnified party to assume the defense of such action within a reasonable
time after receiving notice of the commencement of the action, in each of which cases the reasonable fees, disbursements and other charges
of counsel will be at the expense of the indemnifying party or parties. It is understood that the indemnifying party or parties shall
not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable fees, disbursements
and other charges of more than one separate firm (plus local counsel) admitted to practice in such jurisdiction at any one time for all
such indemnified party or parties. All such fees, disbursements and other charges will be reimbursed by the indemnifying party promptly
after the indemnifying party receives a written invoice relating to such fees, disbursements and other charges in reasonable detail. An
indemnifying party will not, in any event, be liable for any settlement of any action or claim effected without its written consent. No
indemnifying party shall, without the prior written consent of each indemnified party, settle or compromise or consent to the entry of
any judgment in any pending or threatened claim, action or proceeding relating to the matters contemplated by this Section 9 (whether
or not any indemnified party is a party thereto), unless such settlement, compromise or consent (1) includes an unconditional release
of each indemnified party, in form and substance reasonably satisfactory to such indemnified party, from all liability arising out of
such claim, action or proceeding and (2) does not include a statement as to or an admission of fault, culpability or a failure to act
by or on behalf of any indemnified party.
(d) Settlement
Without Consent if Failure to Reimburse. If an indemnified party shall have requested an indemnifying party to reimburse the
indemnified party for reasonable fees and expenses of counsel for which it is entitled to be reimbursed under this Section 9, such indemnifying
party agrees that it shall be liable for any settlement of the nature contemplated by Section 9(a) effected without its written consent
if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the aforesaid request, (ii) such
indemnifying party shall have received notice of the terms of such settlement at least 30 days prior to such settlement being entered
into and (iii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to
the date of such settlement.
(e) Contribution.
In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in the foregoing paragraphs
of this Section 9 is applicable in accordance with its terms but for any reason is held to be unavailable or insufficient from the Company
or the Agent, the Company and the Agent will contribute to the total losses, claims, liabilities, expenses and damages (including any
investigative, legal and other expenses reasonably incurred in connection with, and any amount paid in settlement of, any action, suit,
investigation or proceeding or any claim asserted, but after deducting any contribution received by the Company from persons other than
the Agent, such as persons who control the Company within the meaning of the Securities Act, officers of the Company who signed the Registration
Statement and directors of the Company, who also may be liable for contribution) to which the Company and the Agent may be subject in
such proportion as shall be appropriate to reflect the relative benefits received by the Company on the one hand and the Agent on the
other hand. The relative benefits received by the Company on the one hand and the Agent on the other hand shall be deemed to be in the
same proportion as the total Net Proceeds from the sale of the Placement Shares (before deducting expenses) received by the Company bear
to the total compensation received by the Agent from the sale of Placement Shares on behalf of the Company. If, but only if, the allocation
provided by the foregoing sentence is not permitted by applicable law, the allocation of contribution shall be made in such proportion
as is appropriate to reflect not only the relative benefits referred to in the foregoing sentence but also the relative fault of the Company,
on the one hand, and the Agent, on the other hand, with respect to the statements or omission that resulted in such loss, claim, liability,
expense or damage, or action, suit, investigation or proceeding in respect thereof, as well as any other relevant equitable considerations
with respect to such offering. Such relative fault shall be determined by reference to, among other things, whether the untrue or alleged
untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company
or the Agent, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such
statement or omission. The Company and the Agent agree that it would not be just and equitable if contributions pursuant to this Section
9(e) were to be determined by pro rata allocation or by any other method of allocation that does not take into account the equitable
considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, liability, expense
or damage, or action, suit, investigation or proceeding in respect thereof, referred to above in this Section 9(e) shall be deemed to
include, for the purpose of this Section 9(e), any legal or other expenses reasonably incurred by such indemnified party in connection
with investigating or defending any such action, suit, investigation, proceeding or claim to the extent consistent with this Section 9.
Notwithstanding the foregoing provisions of this Section 9(e), the Agent shall not be required to contribute any amount in excess of the
commissions received by it under this Agreement and no person found guilty of fraudulent misrepresentation (within the meaning of Section
11(f) of the Securities Act) will be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.
For purposes of this Section 9(e), any person who controls a party to this Agreement within the meaning of Section 15 of the Securities
Act or Section 20 of the Exchange Act, any affiliates of the Agent, any partners, members, directors, officers, employees and agents of
the Agent and each person that is controlled by or under common control with the Agent will have the same rights to contribution as that
party, and each officer and director of the Company who signed the Registration Statement will have the same rights to contribution as
the Company, subject in each case to the provisions hereof. Any party entitled to contribution, promptly after receipt of notice of commencement
of any action against such party in respect of which a claim for contribution may be made under this Section 9(e), will notify any such
party or parties from whom contribution may be sought, but the omission to so notify will not relieve that party or parties from whom
contribution may be sought from any other obligation it or they may have under this Section 9(e) except to the extent that the failure
to so notify such other party materially prejudiced the substantive rights or defenses of the party from whom contribution is sought.
Except for a settlement entered into pursuant to the last sentence of Section 9(c) hereof or pursuant to Section 9(d) hereof, no party
will be liable for contribution with respect to any action or claim settled without its written consent if such consent is required pursuant
to Section 9(c) hereof.
10. Representations
and Agreements to Survive Delivery. The indemnity and contribution agreements contained in Section 9 of this Agreement and all representations
and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of their respective dates, regardless
of (i) any investigation made by or on behalf of the Agent, any controlling persons, or the Company (or any of their respective officers,
directors, employees or controlling persons), (ii) delivery and acceptance of the Placement Shares and payment therefor or (iii) any termination
of this Agreement.
11. Termination.
(a) The
Agent shall have the right, by giving notice as hereinafter specified, at any time to terminate this Agreement if (i) any Material Adverse
Effect, or any development that could reasonably be expected to result in a Material Adverse Effect, has occurred that, in the judgment
of the Agent, may materially impair the ability of the Agent to sell the Placement Shares hereunder, (ii) the Company shall have failed,
refused or been unable to perform any agreement on its part to be performed hereunder; provided, however, in the case of
any failure of the Company to deliver (or cause another person to deliver) any certification, opinion or letter required under Section
7(m), Section 7(n), Section 7(o) or Section 7(p), the Agent’s right to terminate shall not arise unless such failure to deliver
(or cause to be delivered) continues for more than 15 calendar days from the date such delivery was required, (iii) any other condition
of the Agent’s obligations hereunder is not fulfilled, (iv) any suspension or limitation of trading in the Placement Shares or in
securities generally on Nasdaq shall have occurred, (v) a general banking moratorium shall have been declared by any of United States
federal or New York authorities, or (vi) there shall have occurred any outbreak or escalation of national or international hostilities
or any crisis or calamity, or any change in the United States or international financial markets, or any substantial change or development
involving a prospective substantial change in United States or international political, financial or economic conditions that, in the
judgment of the Agent, may materially impair the ability of the Agent to sell the Placement Shares hereunder or to enforce contracts for
the sale of securities. Any such termination shall be without liability of any party to any other party except that the provisions of
Section 7(g), Section 9, Section 10, Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such
termination. If the Agent elects to terminate this Agreement as provided in this Section 11(a), the Agent shall provide the required notice
as specified in Section 12.
(b) The
Company shall have the right, by giving 10 days’ prior notice as hereinafter specified, to terminate this Agreement in its sole
discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party
except that the provisions of Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 hereof shall remain in full
force and effect notwithstanding such termination.
(c) The
Agent shall have the right, by giving 10 days’ prior notice as hereinafter specified, to terminate this Agreement in its sole discretion
at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party except that
the provisions of Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 hereof shall remain in full force
and effect notwithstanding such termination.
(d) Unless
earlier terminated pursuant to this Section 11, this Agreement shall automatically terminate upon the issuance and sale of all of the
Placement Shares through or to the Agent on the terms and subject to the conditions set forth herein; provided that the provisions
of Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding
such termination.
(e) This
Agreement shall remain in full force and effect unless terminated pursuant to Sections 11(a), (b), (c), or (d) above or otherwise by mutual
agreement of the parties; provided, however, that any such termination by mutual agreement shall in all cases be deemed
to provide that Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 shall remain in full force and effect.
(f) Any
termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however, that such
termination shall not be effective until the close of business on the date of receipt of such notice by the Agent or the Company, as the
case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such Placement Shares shall
settle in accordance with the provisions of this Agreement. Upon termination of this Agreement, the Company shall not be required to pay
to the Agent any discount or commission with respect to any Placement Shares not otherwise sold by the Agent under this Agreement; provided,
however, that the Company shall remain obligated to reimburse the Agent’s expenses pursuant to Section 7(g).
12. Notices.
All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of this Agreement
shall be in writing, unless otherwise specified in this Agreement, and if sent to the Agent, shall be delivered to:
Leerink Partners LLC
1301 Avenue of the Americas, 12th Floor
New York, New York 10019
Attention: Peter M. Fry
E-mail: peter.fry@leerink.com
with a copy (which shall not constitute notice) to:
Leerink Partners LLC
1301 Avenue of the Americas, 12th Floor
New York, New York 10019
Attention: Legal Department
E-mail: LegalNotice@leerink.com
and if to the Company, shall be delivered to:
Modular Medical, Inc.
10740 Thornmint Road
San Diego, CA 92127
Attention: James Besser
E-mail: jbesser@mgfund.com
with copies (which shall not constitute notice) to:
Lucosky Brookman LLP
101 Wood Avenue South
Woodbridge, NJ 08830
Attention: Lawrence Metelitsa
E-mail: lmetelitsa@lucbro.com
Each party to this Agreement may change such address for notices by
sending to the parties to this Agreement written notice of a new address for such purpose. Each such notice or other communication shall
be deemed given (i) when delivered personally on or before 4:30 P.M., New York City time, on a Business Day, or, if such day is not a
Business Day, on the next succeeding Business Day, (ii) by Electronic Notice as set forth in the next paragraph, (iii) on the next Business
Day after timely delivery to a nationally-recognized overnight courier or (iv) on the Business Day actually received if deposited in the
U.S. mail (certified or registered mail, return receipt requested, postage prepaid). For purposes of this Agreement, “Business
Day” shall mean any day on which the Nasdaq and commercial banks in the City of New York are open for business.
An electronic communication (“Electronic Notice”)
shall be deemed written notice for purposes of this Section 12 if sent to the electronic mail address specified by the receiving party
in Section 12. Electronic Notice shall be deemed received at the time the party sending Electronic Notice receives actual acknowledgment
of receipt from the person whom the notice is sent, other than via auto-reply. Any party receiving Electronic Notice may request and shall
be entitled to receive the notice on paper, in a nonelectronic form (“Nonelectronic Notice”), which shall be
sent to the requesting party within 10 days of receipt of the written request for Nonelectronic Notice.
13. Successors
and Assigns. This Agreement shall inure to the benefit of and be binding upon the Company and the Agent and their respective successors
and the affiliates, controlling persons, officers, directors and other persons referred to in Section 9 hereof. References to any of the
parties contained in this Agreement shall be deemed to include the successors and permitted assigns of each such party. Nothing in this
Agreement, express or implied, is intended to confer upon any party other than the parties hereto, the persons referred to in the preceding
sentence and their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of
this Agreement, except as expressly provided in this Agreement. Neither party may assign its rights or obligations under this Agreement
without the prior written consent of the other party; provided, however, that the Agent may assign its rights and obligations hereunder
to an affiliate of the Agent without obtaining the Company’s consent, so long as such affiliate is a registered broker-dealer.
14. Adjustments
for Share Splits. The parties acknowledge and agree that all share-related numbers contained in this Agreement shall be adjusted to
take into account any share split, share dividend or similar event effected with respect to the Common Stock.
15. Entire
Agreement; Amendment; Severability; Waiver. This Agreement (including all schedules (as amended pursuant to this Agreement) and exhibits
attached hereto and Placement Notices issued pursuant hereto) constitutes the entire agreement and supersedes all other prior and contemporaneous
agreements and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Agreement
nor any term hereof may be amended except pursuant to a written instrument executed by the Company and the Agent; provided, however,
that Schedule 2 of this Agreement may be amended by either party from time to time by sending a notice containing a revised
Schedule 2 to the other party in the manner provided in Section 12 and, upon such amendment, all references herein to Schedule
2 shall automatically be deemed to refer to such amended Schedule 2. In the event that any one or more of the provisions
contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable as written by a court of competent
jurisdiction, then such provision shall be given full force and effect to the fullest possible extent that it is valid, legal and enforceable,
and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal or unenforceable term or provision
was not contained herein, but only to the extent that giving effect to such provision and the remainder of the terms and provisions hereof
shall be in accordance with the intent of the parties as reflected in this Agreement. No implied waiver by a party shall arise in the
absence of a waiver in writing signed by such party. No failure or delay in exercising any right, power, or privilege hereunder shall
operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise
of any right, power, or privilege hereunder.
16. GOVERNING
LAW AND TIME; WAIVER OF JURY TRIAL. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF
NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAWS. SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME. EACH PARTY HEREBY
IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING
OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
17. Consent
to Jurisdiction. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the
City of New York, Borough of Manhattan, for the adjudication of any dispute hereunder or in connection with any of the transactions contemplated
hereby, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally
subject to the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum, or that the venue
of such suit, action or proceeding is improper. Each party hereby irrevocably waives personal service of process and consents to process
being served in any such suit, action or proceeding by mailing a copy (certified or registered mail, return receipt requested) to such
party at the address in effect for notices under Section 12 of this Agreement and agrees that such service shall constitute good and sufficient
notice of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner
permitted by law.
18. Construction.
(a) The
section and exhibit headings herein are for convenience only and shall not affect the construction hereof.
(b) Words
defined in the singular shall have a comparable meaning when used in the plural, and vice versa.
(c) The
words “hereof,” “hereto,” “herein” and “hereunder” and words of similar import, when used
in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.
(d) Wherever
the word “include,” “includes” or “including” is used in this Agreement, it shall be deemed to be
followed by the words “without limitation.”
(e) References
herein to any gender shall include each other gender.
(f) References
herein to any law, statute, ordinance, code, regulation, rule or other requirement of any governmental authority shall be deemed to refer
to such law, statute, ordinance, code, regulation, rule or other requirement of any governmental authority as amended, reenacted, supplemented
or superseded in whole or in part and in effect from time to time and also to all rules and regulations promulgated thereunder.
19. Permitted
Free Writing Prospectuses. Each of the Company and the Agent represents, warrants and agrees that, unless it obtains the prior written
consent of the other party, which consent shall not be unreasonably withheld,
conditioned or delayed, it has not made and will not make any offer relating to the Placement Shares that would constitute an issuer free
writing prospectus, or that would otherwise constitute a free writing prospectus (as defined in Rule 405), required to be filed with the
Commission. Any such free writing prospectus consented to by the Agent or
by the Company, as the case may be, is hereinafter referred to as a “Permitted Free Writing Prospectus.” The
Company represents and warrants that it has treated and agrees that it will treat each Permitted Free Writing Prospectus as an issuer
free writing prospectus, and that it has complied and will comply with the requirements of Rule 433 applicable to any Permitted Free Writing
Prospectus, including timely filing with the Commission where required, legending and record keeping.
20. Absence
of Fiduciary Relationship. The Company acknowledges and agrees that:
(a) the
Agent has been retained to act as sales agent in connection with the sale of
the Placement Shares, the Agent has acted at arms’ length and no
fiduciary or advisory relationship between the Company or any of its respective affiliates, stockholders (or other equity holders), creditors
or employees or any other party, on the one hand, and the Agent, on the
other hand, has been or will be created in respect of any of the transactions contemplated by this Agreement, irrespective of whether
the Agent has advised or is advising the Company on other matters and
the Agent has no duties or obligations to the Company with respect to
the transactions contemplated by this Agreement except the obligations expressly set forth herein;
(b) the
Company is capable of evaluating, and understanding and understands and accepts, the terms, risks and conditions of the transactions contemplated
by this Agreement;
(c) neither
the Agent nor its affiliates have provided any legal, accounting, regulatory
or tax advice with respect to the transactions contemplated by this Agreement and it has consulted its own legal, accounting, regulatory
and tax advisors to the extent it has deemed appropriate;
(d) the
Company has been advised and is aware that the Agent and its affiliates
are engaged in a broad range of transactions which may involve interests that differ from those of the Company and that the Agent
and its affiliates have no obligation to disclose such interests and transactions
to the Company by virtue of any fiduciary, advisory or agency relationship or otherwise; and
(e) the
Company waives, to the fullest extent permitted by law, any claims it may have against the Agent or
its affiliates for breach of fiduciary duty or alleged breach of fiduciary duty in connection with the transactions contemplated by this
Agreement and agrees that the Agent and its affiliates shall have no liability
(whether direct or indirect) to the Company in respect of such a fiduciary claim or to any person asserting a fiduciary duty claim on
behalf of or in right of the Company, including stockholders (or other equity holders), creditors or employees of the Company.
21. Recognition
of the U.S. Special Resolution Regimes. In the event that the Agent is a Covered Entity and becomes subject to a proceeding under
a U.S. Special Resolution Regime, the transfer from the Agent of this Agreement, and any interest and obligation in or under this Agreement,
will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and
any such interest and obligation, were governed by the laws of the United States or a state of the United States.
In the event that the Agent is a Covered Entity
and the Agent or a BHC Act Affiliate of the Agent becomes subject to a proceeding under a U.S. Special Resolution Regime, Default Rights
under this Agreement that may be exercised against the Agent are permitted to be exercised to no greater extent than such Default Rights
could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States or a state
of the United States.
For purposes of this Agreement, (A) “BHC
Act Affiliate” has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12
U.S.C. § 1841(k); (B) “Covered Entity” means any of the following: (i) a “covered entity” as that term is
defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b); (ii) a “covered bank” as that term is defined
in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or (iii) a “covered FSI” as that term is defined in, and
interpreted in accordance with, 12 C.F.R. § 382.2(b); (C) “Default Right” has the meaning assigned to that term in, and
shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable; and (D) “U.S. Special Resolution
Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the
Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
22. Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Delivery of an executed Agreement by one party to the other may be made by facsimile or electronic
transmission. Counterparts may be delivered via facsimile, electronic mail (including any electronic signature covered by the U.S.
federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g.,
www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered
and be valid and effective for all purposes.
23. Use
of Information. The Agent may not provide any information gained in connection with this Agreement and the transactions contemplated
by this Agreement, including due diligence, to any third party other than its legal counsel advising it on this Agreement and the transactions
contemplated by this Agreement unless expressly approved by the Company in writing.
24. Agent’s
Information. As used in this Agreement, “Agent’s Information” means solely the following information
in the Registration Statement and the Prospectus: the first and third sentences of the eighth paragraph and the tenth paragraph under
the heading “Plan of Distribution” in the Prospectus Supplement.
All references in this Agreement to the Registration
Statement, the Prospectus or any amendment or supplement to any of the foregoing shall be deemed to include the copy filed with the Commission
pursuant to EDGAR. All references in this Agreement to financial statements and schedules and other information that is “contained,”
“included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import)
shall be deemed to mean and include all such financial statements and schedules and other information that is incorporated by reference
in the Registration Statement or the Prospectus, as the case may be.
All
references in this Agreement to “supplements” to the Prospectus shall include any supplements, “wrappers” or similar
materials prepared in connection with any offering, sale or private placement of any Placement Shares by the Agent outside
of the United States.
[Remainder of Page Intentionally Blank]
If
the foregoing correctly sets forth the understanding between the Company and the Agent,
please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between the
Company and the Agent.
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Very truly yours, |
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MODULAR MEDICAL, INC. |
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By: |
/s/ James E Besser |
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Name: |
James E Besser |
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Title: |
CEO |
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ACCEPTED as of the date |
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first-above written: |
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LEERINK PARTNERS LLC |
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By: |
/s/ Peter M. Fry |
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Name: |
Peter M. Fry |
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Title: |
Head of Alternative Equities |
SCHEDULE 1
FORM OF PLACEMENT NOTICE
From: |
[ ] |
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[TITLE] |
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Modular Medical, Inc. |
Cc: |
[ ]
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To: |
Leerink Partners LLC |
Subject: |
Leerink Partners —At the Market Offering—Placement Notice |
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Ladies and Gentlemen:
Pursuant to the terms and subject to the conditions
contained in the Sales Agreement, dated November 22, 2023 (the “Agreement”), by and between Modular Medical,
Inc., a Nevada corporation (the “Company”), and Leerink Partners LLC (“Leerink Partners”),
I hereby request on behalf of the Company that Leerink Partners sell up to [ ] shares of common stock, $0.001 par value per share, of
the Company (the “Shares”), at a minimum market price of $ per share[; provided
that no more than [ ] Shares shall be sold in any one Trading Day (as such term is defined in Section 3 of the Agreement)]. Sales should
begin [on the date of this Placement Notice] and end on [DATE] [until all Shares that are the subject of this Placement Notice are sold].
SCHEDULE 2
The Company |
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James Besser |
jbesser@mgfund.com |
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Leerink Partners |
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Michael Giaquinto |
michael.giaquinto@leerink.com |
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atm@leerink.com |
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SCHEDULE 3
Compensation
The
Company shall pay Leerink Partners compensation in cash equal to
3.0% of the gross proceeds from the sales of Placement Shares pursuant to the terms of the Sales Agreement of which this Schedule
3 forms a part.
Exhibit 7(m)
OFFICERS’ CERTIFICATE
Each of [●],
the duly qualified and elected Chief Executive Officer of Modular Medical, Inc., a Nevada corporation (the “Company”),
and [●], the duly qualified and elected Chief Financial Officer of the Company, does hereby certify in such individual’s respective
capacity and on behalf of the Company, pursuant to Section 7(m) of the Sales Agreement, dated November 22, 2023 (the “Sales
Agreement”), by and between the Company and Leerink Partners LLC,
that, after due inquiry, to the best of the knowledge of the undersigned:
(i) The
representations and warranties of the Company in Section 6 of the Sales Agreement (A) to the extent such representations and warranties
are subject to qualifications and exceptions contained therein relating to materiality or Material Adverse Effect, are true and correct
on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof, and (B) to the extent such
representations and warranties are not subject to any qualifications or exceptions relating to materiality or Material Adverse Effect,
are true and correct in all material respects as of the date hereof as if made on and as of the date hereof with the same force and effect
as if expressly made on and as of the date hereof.
(ii) The
Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied pursuant to the Sales Agreement
at or prior to the date hereof.
(iii) As
of the date hereof, (A) the Registration Statement complies in all material respects with the requirements of the Securities Act and does
not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order
to make the statements therein not misleading, (B) the Prospectus complies in all material respects with the requirements of the Securities
Act does not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary
in order to make the statements therein, in light of the circumstances under which they were made, not misleading and (C) no event has
occurred as a result of which it is necessary to amend or supplement the Registration Statement or the Prospectus in order to make the
statements therein not untrue or misleading or for clauses (A) and (B) above, to be true and correct.
(iv) There
has been no material adverse change, or any development that could reasonably be expected to result in a material adverse change, in the
condition (financial or otherwise), earnings, results of operations, business, properties, operations, assets, liabilities or prospects
of the Company and its Subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business, since
the date as of which information is given in the Prospectus, as amended or supplemented to the date hereof.
(v) The
Company does not possess any material non-public information.
(vi) The
maximum amount of Placement Shares that may be sold pursuant to the Sales Agreement has been duly authorized by the Company’s board
of directors or a duly authorized committee thereof pursuant to a resolution or unanimous written consent in accordance with the Company’s
amended and restated articles of incorporation, amended and restated bylaws and applicable law.
Capitalized terms used but not defined herein shall
have the meanings ascribed to them in the Sales Agreement.
IN WITNESS WHEREOF, each of the undersigned, in
such individual’s respective capacity as Chief Executive Officer or Chief Financial Officer of the Company, has executed this Officers’
Certificate on behalf of the Company.
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By: |
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Name: |
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Title: |
Chief Executive Officer |
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Date: |
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By: |
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Name: |
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Title: |
Chief Financial Officer |
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Date: |
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[Company Signature Page to Officers’ Certificate]
Exhibit 5.1
November 22, 2023
Modular Medical, Inc.
10740 Thornmint Road
San Diego, CA 92127
RE: |
Registration Statement on Form S-3 |
Ladies
and Gentlemen:
We
have acted as counsel to Modular Medical, Inc., a Nevada corporation (the “Company”), in connection with the
above-referenced registration statement (the “Registration Statement”), the base prospectus dated April 19, 2022
(the “Base Prospectus”) and the prospectus supplement (the “Prospectus Supplement”) dated
November 22, 2023 (the Base Prospectus and the Prospectus Supplement, collectively, the “Prospectus”), relating
to the offering and sale by the Company of shares (the “Shares”) of common stock of the Company, par value $0.001
per share (the “Common Stock”), having an aggregate offering price of up to $6,500,000, pursuant to that certain
Sales Agreement (the “Sales Agreement”) dated November 22, 2023, between the Company and Leerink Partners
LLC. The Shares are covered by the Registration Statement and we understand that the Shares
are to be offered and sold in the manner described in the Prospectus. This opinion is being delivered at the request of the Company
and in accordance with the requirements of Item 601(b)(5) of Regulation S-K promulgated by the Commission.
For purposes of this opinion, we have examined
such documents and reviewed such questions of law as we have considered necessary and appropriate for the purposes of our opinion set
forth below. In rendering our opinion, we have assumed the authenticity of all documents submitted to us as originals, the genuineness
of all signatures and the conformity to authentic originals of all documents submitted to us as copies. We have also assumed the legal
capacity for all purposes relevant hereto of all natural persons and, with respect to all parties to agreements or instruments relevant
hereto other than the Company, that such parties had the requisite power and authority (corporate or otherwise) to execute, deliver and
perform such agreements or instruments, that such agreements or instruments have been duly authorized by all requisite action (corporate
or otherwise), executed and delivered by such parties and that such agreements or instruments are the valid, binding and enforceable obligations
of such parties. As to questions of fact material to our opinions, we have relied upon certificates of officers of the Company and of
public officials.
Based upon and subject to the foregoing, we
are of the opinion that the Shares have been duly authorized and, when issued and sold by the Company and delivered by the Company against
receipt of the purchase price therefor, in the manner contemplated by the Prospectus and the Sales Agreement, will be validly issued,
fully paid and non-assessable.
The
opinions expressed herein are limited to the laws of the Nevada Revised Statute of the State of Nevada and the laws of the State of New
York, as currently in effect, and no opinion is expressed with respect to any other laws or any effect that such other laws may have on
the opinions expressed herein.
We consent to the filing of this opinion with
the SEC as Exhibit 5.1 to the Company’s Current Report on Form 8-K filed on November 22, 2023, which is incorporated by reference
in the Prospectus. We also consent to the reference of our firm under the caption “Legal Matters” in the Prospectus and in
each case in any amendment or supplement thereto. In giving this consent, we do not thereby admit that we are in the category of persons
whose consent is required under Section 7 and Section 11 of the Securities Act of 1933, as amended, or the rules and regulations of the
Securities and Exchange Commission promulgated thereunder.
|
Very Truly Yours, |
|
|
|
/s/ Lucosky Brookman LLP |
|
Lucosky Brookman LLP |
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