CMC Activities definition

CMC Activities means the activities necessary or useful for generating the Information related to the chemistry, manufacturing and controls of any Compound or Licensed Product required for the Regulatory Approval of Licensed Products, as specified by the FDA or other applicable Regulatory Authority.

CMC Activities means those Manufacturing activities and regulatory activities designed to support preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval.

CMC Activities has the meaning set forth in Section 4.6(c).

Examples of CMC Activities in a sentence

• BEAUFOUR IPSEN INDUSTRIE S.A.S. APPENDIX A CMC Activities for BA058 Phase III Radius / Ipsen 1 Stability Batches at Xxxxxx · Component Supply for 1.5ml Cartridge with new crimp cap + current bromobutyl stopper · Stoppers available as standard stock item in Xxxxxx.

• Upon Lumena’s exercise of the Compound Manufacturing Option, as between the Parties, Lumena shall assume sole responsibility for performing CMC Activities with respect to Compound and for the manufacture of Compounds, subject to any Supply Agreement still in effect at such time.

• In the event of any inconsistency between the terms of the Supply Agreements and the terms of this Agreement, the terms of this Agreement shall prevail unless otherwise expressly provided in the Supply Agreements with respect to matters related to manufacture and supply of Compounds or performance of CMC Activities.

• The Manufacture of the Compounds and Collaboration Products, including all process and formulation development in connection therewith, including CMC Activities, shall be overseen and coordinated by the JMC and conducted pursuant to the Manufacturing plan included in the Development Plan and the Commercialization Plan.

• Each Party shall have day-to-day operational control over the Collaboration CMC Activities allocated to it in the CMC Development Plan.

More Definitions of CMC Activities

CMC Activities means the activities conducted to generate the chemistry, manufacturing and controls section of an IND or application for Regulatory Approval.

CMC Activities means any activity related to the manufacturing, management or disposition of the inventory related to raw materials, starting materials, intermediate materials, drug substance or drug product related to the Company Products, including maintenance and closeout of stability studies and storage.

CMC Activities means the chemistry, manufacturing, control and other activities necessary or useful for generating the CMC Information required for Marketing Approval of the Product, including Manufacture of validation and/or clinical trial materials, which are necessary or useful to obtain Marketing Approval of the Product.

CMC Activities means, with respect to a Research Product, product Directed to a ROFN Target, Licensed Compound or Licensed Product, all Manufacturing CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. activities (including the generation of all CMC Data) necessary to support the development or commercialization of such Research Product, product Directed to a ROFN Target, Licensed Compound or Licensed Product, as applicable, at the applicable stage of development, including formulation, process development, process qualification and validation, scale-up, analytic development, product characterization, stability testing, quality assurance and quality control.

CMC Activities means, with respect to Development Candidate drug substance, the activities necessary to generate the chemistry, manufacturing and controls section of a US IND or equivalent filing.

CMC Activities is defined in Section 3.2.2.

CMC Activities means the activities specified in Section 3.1.2.