Company: ATRA
Filing Date: 2025-03-07
Form Type: 10-K
Source: 0000950170-25-035507
Chunk: 109

Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-03-07
Form: 10-K
Item: Item 1A
Chunk 109
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ization Agreement, from Atara to Pierre Fabre have been completed to the reasonable satisfaction of both parties, or ii) December 31, 2025, throughout the remainder of the term of the A&R Commercialization Agreement. Pierre Fabre and we are to use commercially reasonable efforts to achieve this prior to the earlier transfer date from Atara to Pierre Fabre of the first marketing authorization in the Additional Territory or the first BLA. We are in active discussions with Pierre Fabre on accelerating the progressive transfer of all operational activities related to tab-cel, except the BLA sponsorship, to be completed as early as the end of the first quarter of 2025, as well as assumption by Pierre Fabre of certain 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 increase our costs in order to meet our supply obligations and adversely impact our ability to develop our product candidates, and any reduction in amounts of future potential regulatory or commercial milestone payments may impact our future cash flows. 

We also depend on Pierre Fabre to comply with all applicable laws relative to the commercialization of tab-cel in the Additional Territory. The failure of Pierre Fabre to devote sufficient time and effort to the commercialization of tab-cel; to meet their obligations to us, including for future royalty and milestone payments; to adequately deploy business continuity plans in the event of a crisis; and/or to satisfactorily resolve significant disagreements with us or address other factors could have an adverse impact on our financial results and operations. In addition, if Pierre Fabre violates, or are alleged to have violated, any laws or regulations during the performance of their obligations for us, it is possible that we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences. 

Any termination, breach or expiration of the A&R Commercialization Agreement or ancillary agreements, could have a material adverse effect on our financial position, and our obligations under the HCRx Agreement with respect to the Initial Territory, by reducing or eliminating our right to receive fees, milestones and royalties. In such an event, we may be required to devote additional efforts and to incur additional costs associated with the transfer of regulatory approvals