CMC Services Sample Clauses
The CMC Services clause defines the scope and nature of services provided by a Contract Manufacturing Company (CMC) under the agreement. It typically outlines the specific manufacturing, packaging, quality control, and related support activities the CMC will perform for the client, often including timelines, deliverables, and compliance requirements. By clearly delineating the responsibilities and expectations for both parties, this clause ensures that the manufacturing process meets agreed standards and helps prevent misunderstandings or disputes regarding service obligations.
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CMC Services. In accordance with the plan and budget set forth in Appendix 2, AbbVie shall (i) prepare comparability reports, suitable for filing with the FDA and EMA as applicable, relating to changes in the processes for manufacture of Drug Substance and Drug Product as supplied hereunder in comparison with processes employed by AbbVie under the existing IND for ABT-308 for Phase 1 and Phase 2 clinical supply prior to the Development Agreement Effective Date; and (ii) in the event that ***; and (iii) subject to mutual written agreement of the Parties ***, AbbVie shall perform formulation development services and related services in support of chemistry, manufacturing and controls all in preparation for a first Phase 3 trial ((i)-(iii) collectively, “CMC Services”). The JDC shall oversee the performance of the CMC Services.
CMC Services. Following completion of the Development Plan Study, AbbVie shall continue to perform the CMC Services with respect to chemistry, manufacturing and controls with respect to Drug Substance and Drug Product and in support of any associated filings with applicable Regulatory Authorities until the expiration or termination of its obligations to perform the Additional Phase III Supply Services.
CMC Services. Upon AstraZeneca’s reasonable request, Nektar shall use commercially reasonable efforts to provide any CMC services requested by AstraZeneca at Nektar’s [***], to the extent Nektar has the required expertise and experience, and provided that the Parties shall reasonably cooperate to minimize interference with Nektar’s other business commitments.
CMC Services. ACEA shall use Commercially Reasonable Efforts to provide to Sorrento with Chemistry, Manufacturing and Controls (CMC) services, including CMC maintenance, CMC improvement and any other CMC-related services, sufficient to facilitate successful achievement of Regulatory Approval in the Territories, including but not limited to U.S., Europe and Japan, for the Licensed Products, including satisfaction of any and all applicable FDA and European Union registration requirements (collectively, the “CMC Services”). Without limiting the foregoing, the Parties will discuss in good faith and agree on a list of CMC Services, to include descriptions of the scope and details of such CMC Services, within a reasonable period of time after the Effective Date, which list will be attached hereto as Exhibit C and shall not be deemed to limit the foregoing obligations set forth in this Section 3.1(c). From time to time, the Parties may update Exhibit C by mutual written agreement. In consideration of the CMC Services and unless ACEA is in breach of its obligations under this Section 3.1(c), Sorrento will pay to ACEA a monthly fee of [...***...] (the “CMC Services Fee”) up to a total, aggregate amount of [...***...] (the “CMC Services Fee Cap”) during the term of this Agreement. For clarity, in the event that Sorrento has paid CMC Service Fees totalling the CMC Services Fee Cap in the aggregate, ACEA shall continue to provide and perform the CMC Services at no additional cost until Sorrento has successfully achieved Regulatory Approval in the U.S. and Europe for the Licensed Products, including satisfaction of any and all applicable FDA and European Union registration requirements