Fifth Amendment to License, Collaboration, and Option Agreement between Sarepta Therapeutics Three LLC and F. Hoffmann-La Roche Ltd
This amendment updates the existing License, Collaboration, and Option Agreement between Sarepta Therapeutics Three LLC and F. Hoffmann-La Roche Ltd. It revises the terms and deadlines for negotiating and entering into supply agreements for certain products, specifying new timelines for both development and commercial supply agreements. The amendment confirms that all other terms of the original agreement remain in effect, and it is legally binding on both parties. The agreement is governed by New York law and requires written consent for any further changes.
EXHIBIT 10.1
FIFTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT
This FIFTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT (this
“Fifth Amendment”) is made and entered into as of August 31, 2021 (the “Fifth 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, February 4, 2021, and June 23, 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:
Development Supply Agreement. Unless otherwise agreed by the Parties, no later than
Commercial Supply Agreement. Unless otherwise agreed by the Parties, no later than
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and 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,
(a) it has the power and authority to execute and deliver this Fifth Amendment, (b) the execution, delivery, and performance of this Fifth Amendment by it has been duly authorized by all requisite corporate action, and (c) this Fifth 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.
[Signatures Follow]
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IN WITNESS WHEREOF, the Parties have executed this Fifth 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
Name: Claire Steers
Title: Global Alliance Director
By: /s/ Barbara Schroeder de Castro Lopes
Name: Barbara Schroeder de Castro Lopes
Title: Authorized Signatory
[Signature Page To Fifth Amendment To License, Collaboration, and Option Agreement]
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