Fourteenth 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 deadlines and terms for negotiating and entering into supply agreements for certain products, specifying when development and commercial supply agreements must be finalized. The amendment confirms that all other terms of the original agreement remain in effect, and clarifies that, in case of conflict, the terms of this amendment will prevail. The agreement is governed by New York law and is binding on both parties and their successors.
Exhibit 10.74
FOURTEENTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT
This FOURTEENTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION
AGREEMENT (this “Fourteenth Amendment”) is made and entered into as of October 31, 2022 (the “Fourteenth 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, June 23, 2021, August 31, 2021, November 30, 2021, January 5, 2022,
January 28, 2022, March 23, 2022, May 31, 2022, June 23, 2022, July 28, 2022 and August 31, 2022 (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 Fourteenth 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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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 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,
[Signatures Follow]
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IN WITNESS WHEREOF, the Parties have executed this Fourteenth 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/ Hannah Boehm
Name: Hannah Boehm
Title: Legal Counsel