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 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.

Examples of CMC Activities in a sentence

If CMC Activities are completed prior to the end of the CMC Estimated Timeline, the total CMC Fee related to the CMC Activities will still be payable to Paragon.
If Damora requests any material changes to the scope of the CMC Activities, and Paragon, in its sole discretion, agrees to such changes, or if the Parties otherwise agree to changes to the scope of any CMC Activities, then the Parties shall, through the JDC, mutually agree on any amendment to the applicable Research Plan, which shall include such changes, and any adjustments to the CMC Fee (and corresponding CMC Monthly Fee) to account for the impact of such changes on Paragon’s costs.
Paragon may update Exhibit D on a bi-annual basis by providing written notice thereof to Damora at least [***] prior to the end of the [***], and such updated Exhibit D shall only apply to new CMC Activities (i.e., CMC Activities for a Research Program that has not previously been the subject of CMC Activities, or CMC Activities for a CMC Substitution Project Antibody).
If Paragon does not agree to proceed with CMC Activities for the CMC Substitution Project Antibody, the Parties shall amend the applicable Research Plan so that it does not require the performance of any CMC Activities or further payment of the CMC Fee.
If ▇▇▇▇▇▇▇ agrees, in its sole discretion, to perform the CMC Activities for the CMC Substitution Project Antibody, the Parties shall update the applicable Research Plan, a new CMC Fee and CMC Estimated Timeline shall apply to such CMC Activities, and any unpaid portion of the CMC Fee for the CMC Activities for the original CMC Project Antibody shall be waived.

More Definitions of CMC Activities

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

CMC Activities means the activities specified in Section 3.1.2.

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 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.