Document:

TherapeuticsMD,
Inc. 10-Q

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 TechnologiesTherapeuticsMD,
Inc. 10-Q

Exhibit
10.6

 

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. 2 TO THE COMMERCIAL SUPPLY AGREEMENT BETWEEN 

THERAPEUTCSMD, INC. AND CATALENT PHARMA SOLUTIONS, LLC

(Estradiol
softgel capsules)

 

This
Amendment No. 2 to the Commercial Supply Agreement (“Second Amendment”) is made as of this 29th
day of September, 2020 (“Second Amendment Effective Date”) by and between TherapeuticsMD, Inc., a Nevada corporation,
with a place of business at 951 Yamato Road, Suite 220, Boca Raton, Florida 33431 (“Client”), and Catalent
Pharma Solutions, LLC, a Delaware limited liability company, having a place of business at 14 Schoolhouse Road, Somerset, New
Jersey 08873 (“Catalent”).

WHEREAS,
Client and Catalent entered into that certain Commercial Supply Agreement dated April 20, 2016, as amended (the “Agreement”).

WHEREAS,
Client and Catalent desire to amend the Agreement as more fully set forth herein.

NOW,
THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows:

1.                Capitalized Terms. All capitalized terms used in this Second Amendment and not otherwise defined
herein shall have the meanings given to them in the Agreement. For clarity, the term “Agreement” as used in the Agreement
and herein shall mean the Agreement as amended hereby.

 

2.               Section 1.53 of the Agreement, is hereby deleted and replaced with the following:

 

“Territory”
means worldwide, except shall not include countries that are targeted by the comprehensive sanctions, restrictions or embargoes
administered by the United Nations, European Union, United Kingdom, or the United States. Catalent shall not be obliged to Process
Products for sale in any of such countries if it is prevented from doing so, or would be required to obtain or apply for special
permission to do so, due to any restrictions (such as embargoes) imposed on it by any governmental authorities, including without
limitation, those imposed by the U.S. Office of Foreign Asset Control.

    	 

    	 

    
 

EXECUTION VERSION

 

“ROW”
means any country in the Territory excluding the United States, Canada, and Israel.

3.            
The following definition shall be added to Section 1 of the Agreement:

 

“Authorized
Generic(s)” means any drug sold, licensed, or marketed under the Product’s New Drug Application that is marketed,
sold or distributed under a different labeler code, product code, trade name, trademark, or packaging (other than repackaging
the listed drug for use in institutions) than the Product.

4.            
Section 2.1 of the Agreement is hereby amended by adding the following to the end of the Section:

 

“Client
and its Affiliates shall purchase exclusively from Catalent all of Client’s and its Affiliates’ requirements of Product
for sale in the United States, Canada, and Israel. In the event Client or its Affiliate(s), alone or in partnership with a third
party, launches an Authorized Generic, then Client and its Affiliates shall purchase exclusively from Catalent all of Client’s
and Client’s Affiliate’s requirements of the Authorized Generic in the Territory so long as Catalent’s pricing
for the Authorized Generic is competitive with the pricing requirements for the Authorized Generic.”

5.             Section 4.1 of the Agreement, as amended, is hereby deleted in its entirety and replaced with the following: 

Minimum
Requirement. During each Contract Year, Client shall purchase the minimum number of units of Product set forth on Attachment
B (“Minimum Requirement”). If Client does not purchase such Minimum Requirement during any Contract Year, then
within [***] ([***]) days after the end of such Contract Year, Client shall pay Catalent [***] percent ([***]%) of the difference
between (A) the total amount Client would have paid to Catalent if the Minimum Requirement had been fulfilled for the Product
and (B) the sum of all purchases of Product from Catalent during such Contract Year.

6.           
Article 2 of the Agreement is hereby amended by adding the following as a new Section 2.5:

    	 

    	 

    

EXECUTION VERSION

 

Stability
Studies. During the Term, Catalent shall have the right, but not the obligation, to perform all annual stability studies (including
testing and storage) for Product to be sold in the United States at the pricing set forth on Attachment D. If Catalent is unable
to perform the annual stability studies, Client may contract with a Third Party for the performance of the annual stability studies.
Price increases for such stability services shall not exceed [***] percent ([***]%) per year.

7.             Section 7.1 of the Agreement is hereby amended by including the following as a new subsection D:

 

Beginning
January 1, 2021, Client shall pay Catalent the annual Hormone Suite Occupancy fees set forth on Attachment B. Catalent shall submit
an invoice to Client for such fees on January 1, 2021 and each January 1st thereafter during the Term.

8.              Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

Unit
Pricing Increase. The Unit Pricing shall be adjusted on an annual basis, effective on each July 1st (with the first
Unit Pricing adjustment to be effective on July 1, 2017), upon sixty (60) days' prior written notice from Catalent to Client,
to reflect increases in labor, utilities and overhead and shall be in an amount equal to the change in the Producer Price Index
("PPI"), "Pharmaceutical Preparation Manufacturing" (Series ID: PCU325412325412), not seasonally adjusted,
as published by the U.S. Department of Labor, Bureau of Labor Statistics; provided that beginning July 1, 2021 the annual increase
to the Unit Pricing for the PPI for Product to be sold in the United States, Canada, and Israel shall be capped at [***] percent
([***]%) per year. 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 Unit Pricing increase, but which allows enough time for Catalent to provide to Client
the notice required by this Section 7.2. In addition, notwithstanding the foregoing, price increases for raw materials, and components
shall be passed through to Client annually.

9.             Section 16.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

Term.
This Agreement shall commence on the Effective Date and shall continue until through July 22, 2028, unless earlier terminated in
accordance with Section 16.2 (as may be extended in accordance with this Section, the “Term”). The Term shall
automatically be extended for successive two (2)-year periods unless and until one party gives the other party at least twelve
(12) months’ prior written notice of its desire to terminate as of the end of the then-current Term.

    	 

    	 

    
 

EXECUTION VERSION

 

10.             
Attachment B of the Agreement, as amended, is hereby deleted in its entirety and replaced with the revised Attachment B, attached
hereto.

 

11.             
The Agreement is hereby amended by adding Attachment D, attached hereto.

 

12.             
Governing Law. This Second Amendment shall be governed by and construed under the laws of Delaware, USA, excluding its
conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to
this Second Amendment.

 

13.             
No Other Variations. Except as specifically amended herein, all other terms and conditions of the Agreement remain in full
force and effect and shall apply to the construction of this Second Amendment.

 

14.             
Counterparts. This Second Amendment may be executed in one or more counterparts, each of which will be deemed an original
but all of which together will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of
the executed Second Amendment shall constitute an original.

 

IN
WITNESS WHEREOF, the parties have caused their respective duly authorized Representatives to execute this Second Amendment
effective as of the Second Amendment Effective Date.

 

	CATALENT
PHARMA SOLUTIONS, LLC	 	THERAPEUTICSMD, INC.
	 	 	 
	 	 	 
	By:	/s/ Louis B. Weiner	 	By:	 /s/ James D’Arecca
	 	 	 
	Name:	 Louis B. Weiner	 	Name:	James D’Arecca
	 	 	 
	Title:	VP Business Development, NA Softgel	 	Title:	 Chief Financial Officer

 

 

    	 

    	 

    
 

EXECUTION VERSION

 

ATTACHMENT
B

UNIT
PRICING, FEES AND MINIMUM REQUIREMENT FOR US MARKET*

	UNIT**
                                         PRICING Effective through June 30, 2021

        Theoretical
        Batch Size of [***] softgels
        per strength

	Product	Unit
    Strength	Unit
                                         Pricing 

        per
        [***] softgels
        (USD)

	Estradiol
    Softgel Ovule	Estradiol
    10 mcg	$[***]
	Estradiol
    Softgel Ovule	Estradiol
    4 mcg	$[***]
	 	 	 

	 
	UNIT**
                                         PRICING Effective Through June 30, 2021

        Theoretical
        Batch Size of [***]
        softgels per strength 

	Tier
    1 Volume: [***] to [***] Total Softgels Shipped between July 1, 2020 and June 30, 2021
	Product	Unit
    Strength	Unit
    Pricing per 1,000 softgels (USD)
	Estradiol
    Softgel Ovule	Estradiol
    10 mcg	$[***]
	Estradiol
    Softgel Ovule	Estradiol
    4 mcg	$[***]
	Tier
    2 Volume: [***] and over Total Softgels Shipped between July 1, 2020 and June 30, 2021
	Product	Unit
    Strength	Unit
    Pricing per [***] softgels
    (USD) for all incremental volume over [***] softgels
	Estradiol
    Softgel Ovule	Estradiol
    10 mcg	$[***]
	Estradiol
    Softgel Ovule	Estradiol
    4 mcg	$[***]

*
For ROW markets, initial Unit Pricing and annual Unit Pricing increases will be negotiated in good faith between Catalent and
Client to be less than or equal to the Unit Pricing for the United States as required by the Client’s licensee partner’s
pricing requirements for the ROW markets. For the Canada and Israel markets, initial Unit Pricing and annual Unit Pricing increases
will be negotiated in good faith between Catalent and Client to be less than or equal to the Unit Pricing for the United States
as required by the Client’s licensee partner’s pricing requirements for the Canada and Israel markets.

**
One unit is [***] softgel capsules. Unit Pricing includes full API release testing, cost of Processed softgels, Product full release
testing and bulk packaging. Unit Pricing does not include cost of API, tooling or other Product-specific capital items, artwork,
shipping, insurance or duty.

    	 

    	 

    
 

EXECUTION VERSION

 

Unit
Pricing also does not include any testing, retesting or testing supplies other than as expressly set forth in the Specifications.
Unit Pricing is based on certain assumptions as to manufacturing processes, storage conditions, etc. Accordingly, Unit Pricing
is subject to adjustment in the event any such assumptions are subject to revision in connection with the validation of the Product.

	MINIMUM
    REQUIREMENT 
	Contract
    Year	Product	Minimums
    Requirement
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths 	[***]
    capsules 
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules
	[***]	Across
    all strengths	[***]
    capsules

	 
	 
	ADDITIONAL
    FEES
	Type
    of Fee	Amount	Payable
	Product
    Maintenance Fee	$[***]
    for the first strength; $[***] for each additional strength	[***]
	Hormone
    Suite Occupancy Fee	$[***]	[***]

 

    	 

    	 

    

 

EXECUTION VERSION

ATTACHMENT
D

STABILITY
STUDY PRICING

[***]

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