CMC Activities definition

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 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

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

• Ironwood will be responsible for Ironwood’s internal costs, calculated at the FTE Rate, for CMC Activities that are performed by Ironwood for the first 12 months after the date that Astellas first requests in writing that Ironwood commence such CMC Activities, after which such costs will be reimbursed by Astellas by payment within 60 days of quarterly invoices from Ironwood to Astellas.

• I intend this Release to apply in connection with any CMC Activities at any time and anywhere in the world.

• Biocon shall maintain complete and accurate records of the performance of all IND-Enabling Studies and IND-Enabling CMC Activities, including all Data, Inventions and other Information generated or made in the course of such performance, which records shall be maintained in accordance with Biocon’s standard practices and shall in any event be maintained in a manner sufficient for Equillium’s filing of INDs for Product in the Equillium Territory.

• Lumena and/or its Third Party manufacturer shall use the Sanofi Manufacturing Know-How solely for the purpose of manufacturing Compounds and Licensed Products and performing the CMC Activities, in accordance with the terms and conditions of this Agreement, and for no other purpose.

More Definitions of CMC Activities

CMC Activities is defined in Section 3.2.2.

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, with respect to a Research Product, product Directed to a ROFN Target, Licensed Compound or Licensed Product, all Manufacturing 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 chemistry manufacturing controls and related activities in support of Regulatory Filings and Regulatory Approvals for the Product.

CMC Activities has the meaning set forth in Section 7.2(b).

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 means the activities with respect to Licensed Product #1 set out in the CMC Development Plan (or, for the purposes of Section 2.8.3, 2.8.4 and 2.8.5, the activities with respect to Licensed Product #1 proposed to be included in the CMC Development Plan).