CMC Activities definition

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.

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

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.

• 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.

• Upon Lumena’s exercise of the Compound Manufacturing Option, Lumena itself, or through a Third Party contract manufacturer, shall assume responsibility for CMC Activities with respect to Compound and for the manufacture of Compound.

• 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 conduct by Sanofi of any CMC Activities pertaining to Additional Existing Materials that are not described in Exhibit 4.3 shall be subject to the execution and terms and conditions of the Pre-Commercial Supply Agreement.

More Definitions of CMC Activities

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 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/or closeout of stability studies and storage.

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 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.