1.45 “Liability” has the meaning set forth in Section 14.2.1.
1.46 “Manufacture,” “Manufactured,” or “Manufacturing” means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.
1.47 “Manufacturer’s Release” or “Release” has the meaning ascribed to such term in the Clinical Quality Agreement.
1.48 “Manufacturing Costs” has the meaning set forth in Section 6.12.
1.49 “Manufacturing Site” means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.
1.50 “Merck” has the meaning set forth in the preamble.
1.52 “Merck Compound” means pembrolizumab, a humanized anti-human PD-1 monoclonal antibody [*]
1.53 “Merck Inventions” is defined in Section 10.3.
1.54 “NDA” means a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.
1.55 “Non-Conformance” means, with respect to a given unit of Compound, (i) a deviation from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or a circumstance that requires an investigation to assess impact to the quality of the applicable Compound or (ii) that such Compound failed to meet the applicable representations and warranties set forth in Section 2.3. Classification of the Non-Conformance is detailed in the Clinical Quality Agreement.
1.56 “Non-Filing Party” has the meaning set forth in Section 10.1.3.
1.57 “Opting-out Party” has the meaning set forth in Section 10.1.3.
1.58 “Other Party” has the meaning set forth in Section 14.2.3.
1.59 “Party/Parties” has the meaning set forth in the preamble.
1.60 “PD-1 Antagonist” means any small or large molecule that [*].
1.61 “Permitted Use” has the meaning set forth in Section 3.7.
1.62 “Person” means any individual, sole proprietorship, partnership, corporation, business trust, joint stock company, trust, unincorporated organization, association, limited liability company, institution, public benefit corporation, joint venture, entity or governmental entity.