Delay in Performance by XOMA. If Onyx has not materially breached its obligations to assist XOMA or enable XOMA's performance under this Agreement, then Onyx may terminate this Agreement without penalty or further obligation to XOMA (except as otherwise stated in this Section 11.3) upon at least ninety (90) days prior written notice if: (i) XOMA has not initiated manufacture of Drug Substance (defined as thawing a vial of cells in preparation for manufacturing a Batch of Drug Substance) in the Suite by [*]; (ii) XOMA has not manufactured and supplied to Onyx or its designee a Batch of Drug Substance meeting the Specifications (as in existence on the Effective Date) at the [*]L Development Scale (or greater scale) by [*], provided that Onyx has not significantly delayed the timelines for the Project due to Onyx's decisions based on changed needs for ONYX-015 for clinical trials or on implementation of process changes; (iii) XOMA has not manufactured and supplied to Onyx or its designee a Batch of Drug Substance at [*]L Commercial Scale meeting the then-current Specifications by [*], provided that Onyx has not significantly delayed the timelines for the Project due to Onyx's decisions based on changed needs for ONYX-015 for clinical trials on implementation of process changes; or (iv) after the Attainment of Commercial Scale, XOMA fails to successfully manufacture the number of Batches of Drug Substance ordered by Onyx in compliance with its guaranteed minimum annual number of Batches in any applicable twelve (12) month period under Section 5.2. If Onyx's actions, inactions (e.g. Onyx's failure to provide raw materials, etc., pursuant to Section 2.1(b)) or decisions cause a delay in achievement of the target dates in this Section 11.3(a), Onyx and XOMA will in good faith agree upon an extension of the target dates. If Onyx terminates this Agreement pursuant to this Section 11.3(a), Onyx will reimburse XOMA for all appropriate costs under this Agreement incurred by XOMA to the date of notice of termination by Onyx for services performed, for commitments that cannot be canceled, and for resources that cannot be reallocated, and for all other costs that XOMA incurs in transferring the technology to Onyx or a Third Party at Onyx's request pursuant to Section 7.1(b). XOMA will use diligent, commercially reasonable efforts to minimize any costs or obligations that cannot be canceled and to reallocate any resources that were dedicated to the Project.
Appears in 1 contract
Sources: Process Development and Manufacturing Agreement (Xoma LTD)
Delay in Performance by XOMA. If Onyx has not materially breached its obligations to assist XOMA or enable XOMA's performance under this Agreement, then Onyx may terminate this Agreement without penalty or further obligation to XOMA (except as otherwise stated in this Section 11.3) upon at least ninety (90) days prior written notice if:
(i) XOMA has not initiated manufacture of Drug Substance (defined as thawing a vial of cells in preparation for manufacturing a Batch of Drug Substance) in the Suite by [*[ * ];
(ii) XOMA has not manufactured and supplied to Onyx or its designee a Batch of Drug Substance meeting the Specifications (as in existence on the Effective Date) at the [*[ * ]L Development Scale (or greater scale) by [*[ * ], provided that Onyx has not significantly delayed the timelines for the Project due to Onyx's decisions based on changed needs for ONYX-015 for clinical trials or on implementation of process changes;; [ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(iii) XOMA has not manufactured and supplied to Onyx or its designee a Batch of Drug Substance at [*[ * ]L Commercial Scale meeting the then-current Specifications by [*[ * ], provided that Onyx has not significantly delayed the timelines for the Project due to Onyx's decisions based on changed needs for ONYX-015 for clinical trials on implementation of process changes; or
(iv) after the Attainment of Commercial Scale, XOMA fails to successfully manufacture the number of Batches of Drug Substance ordered by Onyx in compliance with its guaranteed minimum annual number of Batches in any applicable twelve (12) month period under Section 5.2. If Onyx's actions, inactions (e.g. Onyx's failure to provide raw materials, etc., pursuant to Section 2.1(b)) or decisions cause a delay in achievement of the target dates in this Section 11.3(a), Onyx and XOMA will in good faith agree upon an extension of the target dates. If Onyx terminates this Agreement pursuant to this Section 11.3(a), Onyx will reimburse XOMA for all appropriate costs under this Agreement incurred by XOMA to the date of notice of termination by Onyx for services performed, for commitments that cannot be canceled, and for resources that cannot be reallocated, and for all other costs that XOMA incurs in transferring the technology to Onyx or a Third Party at Onyx's request pursuant to Section 7.1(b). XOMA will use diligent, commercially reasonable efforts to minimize any costs or obligations that cannot be canceled and to reallocate any resources that were dedicated to the Project.
Appears in 1 contract
Sources: Process Development and Manufacturing Agreement (Onyx Pharmaceuticals Inc)