AMENDMENT NO. 5 TO COMMERCIAL MANUFACTURING SERVICES AGREEMENT
Exhibit 10.1
AMENDMENT NO. 5 TO COMMERCIAL MANUFACTURING SERVICES AGREEMENT
This Amendment No. 5 to the Commercial Manufacturing Services Agreement (“Fifth Amendment”) is made, entered into and effective as of September 27, 2023 (the “Fifth Amendment Effective Date”) by and between ATARA BIOTHERAPEUTICS, INC., a Delaware corporation with offices at 0000 Xxxxxx Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx Xxxx, XX 00000 (“Atara”); and XXXXXXX RIVER LABORATORIES, INC. (successor in interest to COGNATE BIOSERVICES INC.), a Delaware corporation with offices at 0000 Xxxx Xxxxxx Xxxxx, Xxxxx 000, Xxxxxxx, XX 00000 (“Manufacturer”). Each of Atara and Manufacturer are referred to in this Fifth Amendment as a “Party” and together, the “Parties.” All capitalized terms used, but not otherwise defined herein, shall have the same meaning ascribed to them in the Commercial Services Agreement (as defined below).
BACKGROUND
WHEREAS, the Parties have entered into that certain Commercial Manufacturing Services Agreement, effective as of January 1, 2020 (as previously amended by that certain First Amendment, dated as of September 1, 2021; by that certain Second Amendment, dated as of May 25, 2022; by that certain Third Amendment, dated as of August 1, 2022, and by that Fourth Amendment effective as of January 30, 2023, the “Commercial Services Agreement”), pursuant to which Atara engaged Manufacturer to perform certain commercial manufacturing services in relation to Atara’s products, as further described in individual work orders entered into thereunder;
WHEREAS, the Parties desire to amend the Commercial Services Agreement and certain Work Orders thereto as set forth in this Fifth Amendment; and
WHEREAS, Section 15.7 of the Commercial Services Agreement provides that the Commercial Services Agreement may only be modified by a writing signed by authorized representatives of each Party.
NOW, THEREFORE, the Parties desire, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, to amend the Commercial Services Agreement as set forth in this Fifth Amendment as of the Fifth Amendment Effective Date.
“14.1 Term. This Agreement will take effect as of the Effective Date and, unless earlier terminated pursuant to this Article 14, will expire on the earlier of: (i) December 31, 2023; or (ii) Delivery of the final Remaining Batch and final PBMC Batch ordered during the Remaining Period in accordance with the Quality Agreement (the earlier of such dates, the “Final Date” and such period between February 1, 2023 and the Final Date, the “Remaining Period”). Notwithstanding the termination or expiration of this Agreement, the terms and conditions of this Agreement shall continue to apply to any active or in progress Work Orders (including Delivery of the final Remaining Batches and any PBMC Batches ordered during the Remaining Period) until each such Work Order has been completed, expired or otherwise terminated in accordance with the terms herein or therein.”
“8.9 Amended Pricing and Work Orders. Notwithstanding anything in this Agreement or in any Work Order to the contrary:
“The parties agree to negotiate in good faith a new commercial manufacturing agreement by [[***]], and if the parties are unable to finalize such new agreement prior to [[***]], the parties shall mutually agree upon an extension of the Remaining Period, which will include payment of applicable Suite Fees and new Batch commitments to ensure continuity of supply of Product until such new agreement is executed.”
“3.6. Stability Study Planning and Coordination. Manufacturer Representative and Atara Representative, or their respective designees, shall discuss the performance of stability study Services at the weekly operational meeting, including updates on appropriate training, planning, materials, issues and open action items, which may be escalated to the appropriate governance forums as needed.”
[SIGNATURE PAGE TO FOLLOW]
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IN WITNESS WHEREOF, the undersigned have executed this Fifth Amendment as of the Fifth Amendment Effective Date.
By: /s/ Xxxxxx Xxxxxxx Xxxxx Name: Xxxxxx Xxxxxxx Xxxxx: President & CEO Date: 9/29/2023 |
XXXXXXX RIVER LABORATORIES, INC. By: /s/ Xxxxxxx Xxxxx Xxxxx Name: Xxxxxxx Xxxxx Xxxxx: CSVP Global Biologics Testing Solutions Date: 29-Sep-2023
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EXHIBIT A
SUITE FEES
[[***]]
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EXHIBIT B
UPDATED PRODUCTION FORECAST STARTS
[[***]]
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EXHIBIT C
[[***]]
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