TherapeuticsMD, Inc. 10-Q [txmd-10q_093020.htm]

Exhibit 10.5

 

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS
NOT

MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY

DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.

EXECUTION VERSION

 

AMENDMENT NO. 1 TO THE COMMERCIAL SUPPLY AGREEMENT BETWEEN

THERAPEUTICSMD, INC. AND CATALENT PHARMA SOLUTIONS, LLC

(Estradiol and Progesterone softgel capsules)

This Amendment No. 1 (the "First Amendment") by and between THERAPEUTICSMD, INC.
("TXMD") and CATALENT PHARMA SOLUTIONS, LLC ("CATALENT"), to the Agreement (as
defined below), is made as of this 1st day of December, 2017 (the "First
Amendment Effective Date"). TXMD and CATALENT are sometimes herein referred to
individually as a "Party" and collectively as the "Parties".

Unless otherwise defined herein, capitalized terms used in this First Amendment
shall have the meaning provided to such terms in the Agreement.

The following sets forth the background for this First Amendment:

WHEREAS, TXMD and CATALENT entered into that certain Commercial Supply
Agreement, dated June 24, 2016 (the "Agreement"); and

WHEREAS, TXMD and CATALENT wish to amend the Agreement as provided herein.

NOW THEREFORE, in consideration of the foregoing premises and the mutual
covenants and obligations set forth in this First Amendment, the Parties hereby
agree as follows:

1.    The foregoing recitals are hereby incorporated into this First Amendment
and made a part hereof. Capitalized terms used and not otherwise defined herein
shall have the meanings ascribed to them in the Agreement.

2.    The following definitions shall be added to the Agreement.

"Qualification Conditions" shall mean that (A) each Access Fee Payment has been
made by the earlier of (i) June 30, 2018 or (ii) within sixty (60) days of
invoice date for such Access Fee Payment, (B) the Summary Report Payment is made
within sixty (60) days of invoice for such payment, and (C) the Qualification
Quote has not been terminated prior to completion of, or payment for, all Access
Fee Payments and the Summary Report Payment listed in Section 3.1 of the
Qualification Quote. For the avoidance of doubt, the Access Fee Payments do not
include the Summary Report Payment.

"Access Fee Payment(s)" shall mean all Manufacturing Process Development Access
Fee payments listed in Section 3.1 of the Qualification Quote and all costs,
fees and expenses payable by Client pursuant to, or incurred by Client under,
the Qualification Quote.

"Summary Report Payment" shall mean the payment listed in Section 3.1 of the
Qualification Quote that is due upon completion of the Summary Report.

 

 

EXECUTION VERSION

"Qualification Quote" shall mean Quotation SPQ-TIZ-2310.00, between the Parties
and dated as of October 19, 2017, and attached hereto as Attachment C.

3.       Section 4.1 shall be amended by adding the following sentence at the
end of the section:

"If the Qualification Conditions have not been met, the Minimum Requirements set
forth in Attachment B shall revert to the minimum amounts in place prior to the
First Amendment Effective Date."

4.       The following language shall be added to the Agreement as Section 4.8:

"4.8 Additional Equipment. Subject to the terms of the Qualification Quote,
Catalent shall procure, at its sole expense, any additional equipment required
to ensure that it is capable of providing to Client [***] ([***]) softgels of
Product (in the aggregate across all strengths) per Contract Year; provided,
however, that such [***] ([***]) annual figure assumes that Purchase Orders for
Product shall be spread out across the Contract Year."

5.       Section 7.2 of the Agreement is amended by replacing the following PPI
calculation language:

"The initial base period for comparison shall be the twelve (12) month period
ending on the date most closely preceding July 1, 2017, but which allows enough
time for Catalent to provide to Client the notice required by this Section 7.2."

With the following language:

"The initial base period for comparison shall be the twelve (12) month period
ending on the date most closely preceding the effective date of the first price
increase, but which allows enough time for Catalent to provide to Client the
notice required by this Section 7.2."

6.       Section 7.2 of the Agreement is amended by adding the following
language at the end of the section:

"If the Qualification Conditions have been met, the first annual price
adjustment shall be effective on July 1, 2018. If any Product is sold by
Catalent to Client at the Unit Pricing set forth in Attachment B, and the
Qualification Conditions are not met, then Catalent shall have the right to
retroactively increase the Unit Pricing for Product, effective July 1, 2017, and
invoice Client for any additional amounts that Client would have had to pay for
such Product if the retroactively increased pricing had been in effect at the
time of original invoice for such Product."

7.       The MINIMUM REQUIREMENT table in Attachment B of the Agreement is
hereby deleted and replaced with the following:

 

 

EXECUTION VERSION

MINIMUM REQUIREMENT Contract Year Product Minimum Requirement* Contract Year 1
Across all three strengths [***] Softgels Contract Year 2 Across all three
strengths [***] Softgels Contract Year 3 Across all three strengths [***]
Softgels Contract Year 4 Across all three strengths [***] Softgels Contract Year
5 Across all three strengths [***] Softgels Each additional Contract Year Across
all three strengths [***] Softgels

 

*Softgels shipped per Contract Year qualify towards the Minimum Requirement

8.       Exhibit 1 attached to this First Amendment shall be attached to the
Agreement as Attachment C.

9.       This First Amendment shall be governed by the laws of the State of
Delaware, as such laws are applied to contracts entered into and to be performed
within such state as though made and to be fully performed therein without
regard to conflict of laws principles.

10.   The Parties hereby agree that, except as expressly modified herein, all
terms and provisions of the Agreement shall remain unmodified and in full force
and effect.

11.   This First Amendment may be executed in facsimile counterparts, each of
which shall be deemed an original but all of which shall constitute the same
First Amendment.

[SIGNATURE PAGE ON NEXT PAGE]

 

 

 

 

IN WITNESS WHEREOF, the parties have caused this First Amendment to be executed
by their duly authorized representatives as of the day and year first indicated
above.

 

  THERAPEUTICSMD, INC.           By: /s/ John Milligan     Name: John Milligan  
Title: President                     CATALENT PHARMA SOLUTIONS, LLC          
By: /s/ Aris Gennadios, Ph.D     Name: Aris Gennadios, Ph.D   Title: President,
Softgel Technologies