Document:

acor-ex1051_357.htm

Exhibit 10.51

 

Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks [*****].

CONFIDENTIAL

 

FIRST AMENDMENT TO MANUFACTURING SERVICES AGREEMENT

 

THIS FIRST AMENDMENT to the MANUFACTURING SERVICES AGREEMENT (the “First Amendment”) is made and entered into on this 28th day of October 2021 (the “First Amendment Effective Date”), by and between Acorda Therapeutics, Inc. (“Acorda”), a Delaware corporation, and Catalent Massachusetts, LLC (“Manufacturer”), a Delaware limited liability company.

 

RECITALS

 

WHEREAS, Acorda and Manufacturer entered into a Manufacturing Services Agreement (the “Agreement”) having an effective date of 10 February 2021, pursuant to which Manufacturer provides manufacturing and related services to Acorda; and

 

WHEREAS, the Parties desire to amend the Agreement as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, have agreed to amend the terms of the Agreement as follows: 

 

	
1.
	
Definitions.  Capitalized terms used and not otherwise defined in this First Amendment shall have the meaning assigned to them in the Agreement. 

 

	
2.
	
Amendments.

 

	
 
	
i.
	
The following definitions shall be added to Section 1.1 of the Agreement:

 

“Agents” means (a) [*****] who require access to Lock Down Information for a Purpose; and (b) [*****] who require access to Lock Down Information for [*****]. 

 

“Purpose” means, in the case of Product Personnel or Agents [*****]. 

 

	
 
	
ii.
	
The second sentence of Section 2.1(i) of the Agreement shall be deleted and replaced with the following (new language in bold italics):

 

In the event that Acorda should notify Manufacturer that it wishes to add an Acorda product to the definition of “Marketed Product” pursuant to clause (c) of such definition, the Parties shall meet promptly after Manufacturer’s receipt of such notice to determine any amendments to the terms of this Agreement or the Quality Agreement (including in respect of the consideration to be paid by Acorda to Manufacturer hereunder and the applicability, if any, of the sections of this Agreement relating to Lock Down Information (including, but not limited to, 

 

CONFIDENTIAL

 

Sections 10.1(e)(iv), 11.2, 11.3 and Schedules 7 and 8)) that may be required by the inclusion of the product(s) proposed by Acorda in the definition of “Marketed Product” and shall [*****].  

 

	
 
	
iii.
	
Section 2.4 of the Agreement shall be deleted in its entirety and replaced with the following (new language in bold italics):

 

Access to Acorda Intellectual Property and Know-How.  Only Product Personnel, and Agents who have been trained per Schedule 7 shall receive, be involved in or otherwise participate in any [*****] regarding the Supplied Product(s) or otherwise have access to the Acorda Intellectual Property, including [*****].  Manufacturer shall use reasonable efforts to minimize the work of the Product Personnel and Agents on the development of [*****] and shall comply with its ethical wall policy. 

 

	
 
	
iv.
	
Sections 11.2(b), (c), (d), (e), and (f) of the Agreement shall be deleted in its entirety and replaced with the following (new language in bold italics; deleted text shown with strikethrough):

 

(b) Insofar as Manufacturer personnel (which is understood for purposes of this Section 11.2 to include Manufacturer employees and agents and Manufacturer subcontractors and their employees and agents) are concerned, Manufacturer shall provide or permit access to Lock Down Information to only Product Personnel [*****].

 

 

(c) Manufacturer shall inform all Product Personnel and Agents that they are prohibited from providing or disclosing to, or sharing or discussing with, any Manufacturer personnel person who is are not Product Personnel or an Agent engaged in a Purpose any Lock Down Information and shall provide appropriate training (promptly following the Effective Date, in the case of current Product Personnel and Agents, and promptly after reasonable determination of the need for access to Lock Down Information, in the case of any other Product Personnel or Agents) and with reasonable refresher training to all Product Personnel and then-current Agents as to Manufacturer’s obligations in respect of the protection of the confidentiality and use of Lock Down Information under this Agreement, the obligations of the Product Personnel to Manufacture and Agents to perform their duties consistent with an applicable Purpose in that regard, and best practices, to be followed by Product Personnel and Agents (including after they cease to qualify as Product Personnel or Agents), for protecting the confidentiality and use of Lock Down Information as required by this Agreement.  Without limitation, such training shall address those matters set forth on Schedule 8.

  

(d) Manufacturer shall [*****].  Manufacturer shall be responsible for and directly liable to Acorda for any breach of the provisions of this Section 11.2 occasioned by the acts or omissions of Product Personnel or Agents (including after such individuals cease to qualify as Product Personnel or Agents).

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CONFIDENTIAL

 

 

(e) Acorda may request that Manufacturer [*****].

 

(f) Manufacturer shall, and shall cause each of its Affiliates to, implement appropriate access and other restrictions on its internal databases and electronic networks to prevent Manufacturer personnel, third-party contractors, employees, and persons other than Product Personnel and Agents from accessing Lock Down Information.

 

	
 
	
v.
	
The following shall be added to the Manufacturing Services Agreement as Section 11.2(i):

 

Manufacturer shall maintain an accurate and complete list of [*****]. Upon Acorda’s reasonable written request, but not more than twice per calendar year unless Acorda has a good faith belief that (i) it needs the information in connection with a protection or enforcement of its rights against a third party or (ii) there may have been unauthorized access to the  Lock Down Information, Manufacturer shall provide the current [*****] to Acorda.  

 

	
 
	
vi.
	
Schedule 7 to Manufacturing Services Agreement shall be deleted in its entirety and replaced with the following (new language in bold italics):

 

[*****]

 

	
3.
	
No Other Variation.  Except as expressly provided in this First Amendment, all the terms, conditions and provisions of the Agreement (including the rights, duties, liabilities and obligations of the Parties thereunder) remain in full force and effect and shall apply to the construction of this First Amendment.  

 

	
4.
	
Entire Agreement.  This First Amendment and the Agreement, including its attachments, constitute the entire agreement between the Parties relating to the subject matter hereof and thereof, and may not be varied except in writing signed by a duly authorized representative of each Party.  In case of inconsistency between the terms and conditions of the Agreement and this First Amendment, this First Amendment shall prevail to the extent of such inconsistency but no further.  This First Amendment shall be governed in all respects by the terms for resolution of any controversy, dispute or claim provided in the Agreement.

 

	
5.
	
Counterparts.  This First Amendment may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

 

IN WITNESS WHEREOF, the Parties have executed this First Amendment as of the First Amendment Effective Date above written.

 

		
	
Catalent Massachusetts, LLC 
	
Acorda Therapeutics, Inc.

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CONFIDENTIAL

 

		
	
 

Signature: /s/Jonathan Arnold
	
 

Signature: /s/Ron Cohen

	
Name: Jonathan Arnold
	
Name:  Ron Cohen

	
Title: President Oral & Specialty Delivery
	
Title: President & Chief Executive Officer

 

Page 4 of 4acor-ex1052_356.htm

Exhibit 10.52

 

Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks [*****].

EXECUTION VERSION

CONFIDENTIAL

 

SECOND AMENDMENT TO MANUFACTURING SERVICES AGREEMENT

 

THIS SECOND AMENDMENT to the MANUFACTURING SERVICES AGREEMENT (the “Second Amendment”) is made and entered into on this 31st day of December 2021 (the “Second Amendment Effective Date”), by and between Acorda Therapeutics, Inc. (“Acorda”), a Delaware corporation, and Catalent Massachusetts, LLC (“Manufacturer”), a Delaware limited liability company.

 

RECITALS

 

WHEREAS, Acorda and Manufacturer entered into a Manufacturing Services Agreement (the “MSA”) having an effective date of 10 February 2021, as amended by First amendment effective as of 28 October 2021 (collectively with the MSA the “Agreement”) pursuant to which Manufacturer provides manufacturing and related services to Acorda; and

 

WHEREAS, the Parties desire to amend the Agreement as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, have agreed to amend the terms of the Agreement as follows: 

 

	
1.
	
Definitions.  Capitalized terms used and not otherwise defined in this Second Amendment shall have the meaning assigned to them in the Agreement. 

 

	
2.
	
Amendments. 

 

	
 
	
i.
	
The Parties acknowledge and agree that the erroneous reference to Section 7.7(a)(v) in Section 2.7(a)(iv). Credit for Shortfall, of the Agreement shall be removed and replaced with a corrected reference to Section 2.7(a)(v).

 

	
 
	
ii.
	
The reference to Schedule 4 contained in Section 3.1(a) shall be subject to the modifications contained in this Section 2(ii) of this Second Amendment. The distinction in Schedule 4 for the Product Fees between capsules provided for sale in the United States/Japan and other territories shall not apply for the Firm Batches (defined below) Manufactured in Q3 and Q4 of 2021 and Q1 and Q2 of 2022; instead, Acorda shall pay (a) $[*****]/capsule for [*****] demo Batches contained in the Firm Batches and (b) $[*****]/capsule (regardless of volume) for the [*****] commercial Batches contained within the Firm Batches, regardless of whether the commercial Firm Batches are to be sold in the United States or elsewhere. In no event shall total payments for the Product Fees for the Firm Batches Manufactured through June 30, 2022 and any payments previously made in 2021 exceed $23,177,777.77 (for clarity, this spending limit does not include other fees set forth in the Agreement, including, but not limited to, testing fees, storage fees, and fees for Product Maintenance Services).  In addition, the Net Sales calculation set forth in the second sentence of Section 3.1(a), the Minimum Commitment set forth in Section 1.1, and the True-Up for Minimum Commitment set forth in Section 3.1(c) will not 

 

 

	
 
		
apply during these same four (4) Quarters (Q3 and Q4 of 2021 and Q1 and Q2 of 2022). For clarity, (a) in the event that that the Agreement is terminated by Acorda after the temporary four Quarter suspension and Section 8.4(a)(iii) applies, Acorda will be deemed to have satisfied the Minimum Commitment during the temporary four Quarter suspension under this Second Amendment; and (b)  any resulting reduction in the total amount Acorda pays or would have paid to Manufacturer if the Minimum Commitment had been fulfilled for the Supplied Product shall not be added to the Minimum Commitment of the last Year of the Initial Term as set forth in the definition of Minimum Commitment in Section 1.1. 

 

	
 
	
iii.
	
The Parties agree to the following:

 

Acorda will issue an updated monthly two-year forecast, which will include a total of [*****] Batches ([*****] commercial Batches and [**] demo Batches) through Q2 of 2022 (“Firm Batches”), which the Parties have agreed is a Firm Commitment.  Acorda shall issue Purchase Orders for the Firm Batches in accordance with the Agreement.  Acorda shall only be responsible for paying the fixed per capsule price set forth in Section 2(ii) of this Second Amendment for each Firm Batch upon tender of delivery.  

 

	
 
	
iv.
	
The following shall be added to Section 3.2(b), Payments, Invoicing, of the Agreement: 

 

If, after completion of Acorda’s review of Batch records and release of Supplied Product for delivery in accordance with the Quality Agreement, Acorda fails to take delivery of any Supplied Product and such failure is not due to Manufacturer Defective Manufacturing, Manufacturer shall be permitted to invoice Acorda for the Batch upon placement into storage.  Further, for all Batches Manufactured in December 2021, Manufacturer may invoice Acorda following release of the Supplied Product; provided, however, that such invoicing shall have no bearing on Acorda’s right to inspect Batch records or make determinations of deviations from the Compliant Product Requirements in accordance with the Agreement and the Quality Agreement. 

 

	
 
	
v.
	
Catalent shall be permitted to invoice Acorda for any Firm Batches Manufactured through the end of Q2 2022 (even if released by Acorda subsequent to the end of Q2 2022), and will be paid subject to Acorda’s right to inspect Batch records or make determinations of deviations from the Compliant Product Requirements in accordance with the Agreement and the Quality Agreement and expiration of any applicable review periods specified therein.

 

	
 
	
vi.
	
The provisions of Section 6.1 of the Agreement shall not apply to Firm Batches.

 

	
 
	
vii.
	
Section 5.2, Storage Fees, of the Agreement shall be deleted in its entirety and replaced with the following:

 

Storage Fees.  If, after completion of Acorda’s review of Batch records and release of Supplied Product for delivery in accordance with the Quality Agreement, Acorda fails to take delivery of any Supplied Product and such failure is not due to Manufacturer Defective Manufacturing, to the extent that space is available, Manufacturer shall store such Supplied Product and have the right to invoice Acorda monthly for reasonable administration and storage costs. 

 

	
 
	
viii.
	
Manufacturer has agreed to pay for the installation and qualification of the PSD7 as referenced in Schedule 4 to the Agreement.  The Parties agree that commencing on the later of January 1, 

 

 

	
 
		
2024 or the first Quarter following qualification and approval for use of the PSD7 by the FDA, Acorda shall pay to Manufacturer the sum of $375,000.00 per Quarter for a total of four (4) successive Quarters. For purposes of clarity, the foregoing aggregate payment of  $1.5 million shall not impact the Minimum Commitment.

 

	
 
	
ix.
	
Manufacturer and Acorda agree to negotiate in good faith with respect to [*****], taking into consideration the provisions of Section 2.1 of the Agreement and [*****], with the goal of providing a cost-effective solution for [*****]; provided, however, that nothing contained herein shall limit Acorda’s rights under Section 2.5 of the Agreement.

 

	
3.
	
No Other Variation.  Except as expressly provided in this Second Amendment, all the terms, conditions and provisions of the Agreement (including the rights, duties, liabilities and obligations of the Parties thereunder) remain in full force and effect and shall apply to the construction of this Second Amendment.  

 

	
4.
	
Entire Agreement.  This Second Amendment and the Agreement, including its attachments, constitute the entire agreement between the Parties relating to the subject matter hereof and thereof, and may not be varied except in writing signed by a duly authorized representative of each Party.  In case of inconsistency between the terms and conditions of the Agreement and this Second Amendment, this Second Amendment shall prevail to the extent of such inconsistency but no further.  This Second Amendment shall be governed in all respects by the terms for resolution of any controversy, dispute or claim provided in the Agreement.

 

	
5.
	
Counterparts.  This Second Amendment may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.  A facsimile or other reproduction of this Second Amendment may be executed by the Parties and may be delivered by facsimile or similar electronic transmission device pursuant to which the signature(s) can be seen, and such execution and delivery shall be considered valid, binding and effective for all purposes.  

 

IN WITNESS WHEREOF, the Parties have executed this Second Amendment as of the Second Amendment Effective Date above written.

 

		
	
Catalent Massachusetts, LLC 
	
Acorda Therapeutics, Inc.

	
 

Signature: /s/Jonathan Arnold
	
 

Signature: /s/Ron Cohen

	
Name: Jonathan Arnold
	
Name:  Ron Cohen

	
Title: President Oral & Specialty Delivery
	
Title: President & Chief Executive Officer

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