Current Report Filing (8-k)
January 23 2023 - 8:46AM
Edgar (US Regulatory)
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2023-01-18
2023-01-18
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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): January 18, 2023
RESPIRERX
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
1-16467 |
|
33-0303583 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S
Employer
Identification
No.) |
126
Valley Road, Suite C
Glen
Rock, New Jersey |
|
07452 |
(Address of principal
executive offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code: (201) 444-4947
(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)) |
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
RespireRx
Pharmaceuticals Inc. (OTC Markets: RSPI) and the Board of Trustees of University of Illinois, a body corporate and politic of the State
of Illinois, have agreed to a second amendment (“Second Amendment”) to their Exclusive License Agreement (“License
Agreement”). The License Agreement is effective June 27, 2014 and was amended on August 2, 2017. The Second Amendment is effective
December 15, 2022 and was signed by RespireRx and UIL on January 3, 2023 and January 18, 2023 respectively.
The
parties entered into the Second Amendment in order to add new definitions for and payment obligations related to Deferred Compensation
Annual Net Sales Payments and Deferred Compensation Annual Minimum Payment(s) with an extension of the term of the License in consideration
for modifying financial terms and timelines.
Summarizing
the above: (i) the definition of Product now includes
any product or process that would have been enforceable under the Patent after the Patent Rights have expired, (ii) Deferred Compensation
Annual Net Sales Payments means those payment obligations calculated on Net Sales as set forth in Schedule 2, as amended, but which only
become due and payable after the expiration of the Patent Rights and shall not be due and payable while any of the Patent Rights have
not yet expired and (iii) Deferred Compensation Minimum Payment(s) means those annual payment obligations set forth in Schedule 2 as
amended, which shall only become due and payable after the expiration of the Patent Rights and shall not be due and payable while any
of the Patent Rights have not yet expired.
The
logic behind extending certain financial obligations is based in part on the filing by the Company of a new patent application that was
considered for, but not incorporated into the License. In lieu of incorporating the new patent into the License, the parties agreed to
the new definitions described in (ii) and (iii) above but limited to eight (8) years after the Patent Rights have expired. Therefore,
the new patent is not part of the definition of Patent Rights but the amendment does provide the potential for a similar economic
benefit to the Licensor as if the new patent were assigned to the Licensor and became part of the License.
A
number of additional changes, deletions and additions were made to various sections of the License.
Selected
portions of Schedule 2 that were amended are summarized below:
|
- |
Elimination
of the $100,000 annual payments due by the Company to the Licensor from December 31, 2021 and later. That means that the unpaid amount
of $100,000 for the calendar year 2021 is no longer due and payable and that no payment for 2022 is due and payable |
|
- |
Addition
of 4% royalty with respect to Net Sales by Licensee or Sublicensee as Deferred Compensation Annual Net Sales Payments |
|
- |
The
$150,000 amount that would have been due upon application for regulatory approval has now been eliminated, and
instead replaced with a $350,000 amount
due the first year
with a market approval from the US FDA or
a foreign equivalent and every year thereafter, until first commercial sale of a Product |
|
- |
The
$250,000 annual minimum amount that would have been due the first year of commercial sale of a Product and every year thereafter
is now $400,00. The annual minimum amounts may be satisfied in part or in whole with royalty payments |
|
- |
The
original $75,000 milestone payment that was originally due upon the dosing of a 1st patient with a Product in a Phase
II study not sponsored by the Licensor or the dosing of a 1st patient in a Phase II study with a low dose reformulation
of dronbaninol, has been amended to a $10,000 payment due after the dosing of the 1st patient with a Product in a Phase
II study anywhere in the world |
|
- |
The
$350,000 milestone payment that would have due upon dosing of the 1st patient with a Product in a Phase III study is now
two payments totaling $500,000, $150,000 of which is due upon the dosing of a 1st patient in a Phase III study anywhere
in the world and $350,000 due upon the earlier of enrolling 80% of the patients with a Product in the Phase III study or one year
after the initiation of the Phase III study or the termination of the Phase III study |
|
- |
The
$500,000 and $1,000,000 milestones due after the first NDA and within twelve months of commercial sale respectively remain unchanged |
|
- |
Royalty
stacking provisions remain unchanged. |
The
above is a summary of what the Company believes are key the provisions of the Second Amendment. A copy of the entirety of the Second
Amendment is filed as Exhibit 10.1 to this Current Report on Form 8-K. The above summary is qualified in its entirety by the Current
Report of Form 8-K including the copy of the Second Amendment filed as Exhibit 10.1 to such report.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
A
list of exhibits that are furnished and filed as part of this report is set forth in the Exhibit Index, which follows, and is incorporated
herein by reference.
EXHIBIT
INDEX
*
Filed herewith.
**
Furnished herewith.
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 hereunto duly authorized.
Date:
January 23, 2023 |
RESPIRERX PHARMACEUTICALS INC. |
|
(Registrant) |
|
|
|
By: |
/s/
Jeff E. Margolis |
|
|
Jeff E. Margolis |
|
|
SVP, CFO, Secretary
and Treasurer |
RespireRx Pharmaceuticals (CE) (USOTC:RSPI)
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