Company: ATRA
Filing Date: 2025-03-07
Form Type: 10-K
Source: 0000950170-25-035507
Chunk: 12

Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-03-07
Form: 10-K
Item: Item 1
Chunk 12
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 costs related to the remediation of the third party manufacturing facility to address the FDA’s requests in order to lift the clinical hold and to support resubmission of the BLA for tab-cel.  As part of these discussions, we expect to agree to reduce the amount of certain future potential regulatory and commercial milestone payments relating to tab-cel in the Additional Territory. Any delays in completing the manufacturing transfer to Pierre Fabre will result in us being responsible for supplying tab-cel to Pierre Fabre until the completion of the transfer which will cause us to incur additional costs in order to meet our supply obligations.

In August 2024, we sold certain intermediates used in the manufacture of Ebvallo to Pierre Fabre for $15.5 million, transferring title and risk of loss to these intermediates in advance of the Manufacturing Transition Date. We received payment for these intermediates in September 2024.

We have also entered into research collaborations with leading academic institutions such as Memorial Sloan Kettering Cancer Center (MSK) and the Council of the Queensland Institute of Medical Research (QIMR Berghofer) pursuant to which we acquired rights to novel and proprietary technologies and programs.

Our research facilities in Thousand Oaks, California (ARC) and Aurora, Colorado contain our translational and preclinical sciences, analytical development, and process science functions. These facilities support our product pipeline, process development and leverage our allogeneic cell therapy platform to drive innovation. 

We and FUJIFILM Diosynth Biotechnologies California, Inc. (FDB) entered into a Master Services and Supply Agreement (Fujifilm MSA), which became effective in April 2022 and could extend for up to ten years. Pursuant to the Fujifilm MSA, FDB will supply us with specified quantities of our cell therapy products (if approved) and product candidates, manufactured in accordance with cGMP standards. The Fujifilm MSA does not obligate us to purchase products and product candidates exclusively from FDB. 

7

We also worked with Charles River Laboratories (CRL) pursuant to a Commercial Manufacturing Services Agreement (CRL MSA) that we entered into in December 2019. CRL provided manufacturing services for our product and certain intermediates under the CRL MSA.  The CRL MSA expired on August 31, 2024 and we are currently in negotiations with CRL for a statement of work to support an orderly wind-down of manufacturing activities at CRL, transition of manufacturing