AMENDMENT TO
THE AMENDED AND RESTATED COMMERCIALIZATION AGREEMENT
This Amendment to the Amended and Restated Commercialization Agreement (the “Amendment”), is entered into as of March 31, 2025 (the “Amendment Effective Date”), by and between Atara Biotherapeutics, Inc. (“Atara”) and Pierre Fabre Medicament (“Partner”). Atara and Partner are referred to in this Amendment individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Atara and Partner entered into that certain Amended and Restated Commercialization Agreement, dated as of October 31, 2023, and effective as of December 19, 2023 (the “Agreement”);
WHEREAS, pursuant to the Agreement, Atara granted to Partner and its Affiliates an exclusive, worldwide, remuneration-bearing license, including the right to commercialize the Product (for which Atara submitted a BLA to the U.S. Food and Drug Administration on May 20, 2024) in the United States;
WHEREAS, in connection with such BLA, the FDA issued a Complete Response Letter on January 15, 2025, raising concerns with respect to the manufacturing of the Product at the Atara Manufacturing Facility owned and operated by CRL, located in Memphis, Tennessee and following receipt of such Complete Response Letter from the FDA, Atara and Partner mutually desire to collaborate with each other to establish and implement a plan for remediation of such Atara Manufacturing Facility (such remediation, the “Remediation”) for the purposes of resubmitting such BLA for the Product;
WHEREAS, the Parties have mutually agreed to amend the Agreement as follows, in accordance with Section 16.3 of the Agreement;
NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, and on the terms and subject to the conditions set forth herein, the Parties hereby agree as follows:
AMENDMENT
“CRL” means Charles River Laboratories.