srpt-ex104_218.htm



Exhibit 10.4

 

FOURTH Amendment to License, Collaboration, and Option Agreement

This FOURTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT (this “Fourth Amendment”) is made and entered into as of June 23, 2021 (the “Fourth Amendment Effective Date”) between Sarepta Therapeutics Three LLC, a limited liability company organized and existing under the laws of the State of Delaware, United States of America, with its principal offices at 215 First Street, Cambridge, MA, 02142  (“Sarepta”) and F. Hoffmann-La Roche Ltd, a company organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, 4070 Basel, Switzerland (“Roche”).  Sarepta and Roche may be referred to herein individually as a “Party” and collectively as the “Parties.”

WHEREAS, Sarepta and Roche entered into that certain License, Collaboration, and Option Agreement executed on December 21, 2019 and effective as of February 4, 2020 and amended October 23, 2020, October 28, 2020, and February 4, 2021 (the “Original Agreement”); and

WHEREAS, the Parties desire to make certain further amendments to the Original Agreement;

NOW, THEREFORE, in consideration of the promises and covenants contained in this Amendment, and intending to be legally bound, the Parties hereby agree as follows:


	
1.
	
Interpretation.  Capitalized terms not defined in this Fourth Amendment have the meanings given such terms in the Original Agreement. References to Sections and Schedules herein will be to Sections and Schedules of the Original Agreement, except as otherwise noted.





	
2.
	
Amendments.





	
 
	
a.
	
Section 8.6.1 shall be deleted and replaced by the following:




Development Supply Agreement.  Unless otherwise agreed by the Parties, no later than (a) August 31, 2021, with regards to the Lead Product, and (b) no later than nine months following the effective date of exercise of the Option with regards to every other Licensed Product to which this Article 8 (Manufacturing and Supply) applies in accordance with Section 8.1, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a supply agreement on reasonable and customary terms for the supply of such Licensed Product by Sarepta to Roche in the Roche Territory at the Supply Price (the “Development Supply Agreement”), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of such Licensed Product for Development purposes. The Parties may choose to combine into a single agreement the Development Supply Agreement and the Commercial Supply Agreement for a Licensed Product.  


	
 
	
b.
	
Section 8.6.2 shall be deleted and replaced by the following: 




Commercial Supply Agreement.  Unless otherwise agreed by the Parties, no later than (a) August 31, 2021, with regards to the Lead Product, and (b) no later than twelve (12) months following the effective date of the Option Exercise with regards to every other Licensed Product to which this Article 8 (Manufacturing and Supply) applies in accordance with Section 8.1, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a commercial supply agreement on reasonable and customary terms for the commercial-grade supply of such Licensed Product by Sarepta to Roche in the Roche Territory at the Supply Price (the “Commercial Supply Agreement” and 

 

1



 

together with the Development Supply Agreement, the “Supply Agreements”), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing and supply of such Licensed Product for Commercialization purposes.  As noted above, the Parties may choose to combine into a single agreement the Development Supply Agreement and the Commercial Supply Agreement for a Licensed Product, 


	
3.
	
Effect on Original Agreement.  Except as specifically amended by this Fourth Amendment, the Original Agreement will remain in full force and effect and is hereby ratified and confirmed.  Each future reference to the Original Agreement will refer to the Original Agreement as amended by this Fourth Amendment.  To the extent a conflict arises between the terms of the Original Agreement and this Fourth Amendment, the terms of this Fourth Amendment shall prevail but only to the extent necessary to accomplish their intended purpose.





	
4.
	
Incorporation.  Article 17 of the Original Agreement is hereby incorporated mutatis mutandis into this Amendment.





	
5.
	
Binding Effect. This Fourth Amendment will be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.





	
6.
	
Authority. As of the Fourth Amendment Effective Date, each Party hereby represents and warrants that (a) it has the power and authority to execute and deliver this Fourth Amendment, (b) the execution, delivery, and performance of this Fourth Amendment by it has been duly authorized by all requisite corporate action, and (c) this Fourth Amendment has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against it in accordance with its terms.





	
7.
	
Governing Law. This Fourth Amendment and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties, will be construed under and governed by the laws of the State of New York, United States, exclusive of its conflicts of laws principles.





	
8.
	
Amendments. This Fourth Amendment may not be modified or amended, except by another agreement in writing executed by duly authorized signatories of each Party.





	
9.
	
Counterparts.  This Fourth Amendment may be executed in two or more counterparts, all of which taken together will be regarded as one and the same instrument.  Each Party may execute this Fourth Amendment in AdobeTM Portable Document Format (PDF) sent by electronic mail.  PDF signatures of authorized signatories of the Parties will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this Fourth Amendment. 




[Signatures Follow]

 

 

 

2



 

 

IN WITNESS WHEREOF, the Parties have executed this Fourth Amendment to License, Collaboration, and Option Agreement through their duly authorized representatives.

 


	
Sarepta Therapeutics Three, LLC 

	
By:  /s/ Adam Hopkin

	
Name:  Adam Hopkin

	
Title:  Manager




 


	
F. HOFFMANN-LA ROCHE LTD
	
 

	
By:  /s/ Claire Steers
	
By:  /s/ Dr. Franziska Bachler

	
Name:  Claire Steers
	
Name:  Dr. Franziska Bachler

	
Title:  Global Alliance Director
	
Title:   Legal Counsel




 

 

[Signature Page To Fourth Amendment To License, Collaboration, and Option Agreement]