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 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
GCC shall have the right to conduct preclinical, IND-enabling studies and CMC Activities for the Product (the “Preclinical Studies”) and the first-in-human (FIH) clinical trial of the Product in the Republic of Korea (the “Korean Phase 1a/1b Trial”) in accordance with the Development Plan.
More Definitions of CMC Activities
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 the activities conducted to generate the chemistry, manufacturing and controls section of an IND or application for Regulatory Approval.
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.