definiens: means Intellectual Property generated, acquired or derived by : ( i ) [ * * * ] or ( ii ) [ * * * ] ; means those Components supplied or to be supplied by or on behalf of Client ; means, collectively, all packaging components, raw materials, ingredients, and other materials ( including labels, product inserts and other labelling for the Products ) required to manufacture or package Product in accordance with the Processing Instructions, other than the API ; has the meaning specified in Section 11.1 ; means the Dru g Enforcement Administration of the United States Department of Justice ; has the meaning specified in Section 6.1(a)(i ) ; means in relation to each batch of Product the scheduled date by which the Product will be released by [COMPANY] ’s quality department ( by confirmation or certification, as agreed in the Quality Agreement ) and made available for shipment, and as confirmed by [COMPANY] upon receipt of a Firm Order ; means, collectively, the Master Agree ment for Pharmaceutical Development Services between [COMPANY] and Client dated January 12, 2016 ( the ) and any related Project Proposals issued under the Master Agreement ; means any pharmaceutical research or develop ment service for the Product, including the manufacture of Product validation batches, performed by [COMPANY] for Client before or after the Effective Date and throughout the Term under the Development Agreement ; has the meaning specified in Section 11.1 ; has the meaning specified in Section 6.1(b)(ii ) ; means the European Medicines Agency ; means the United States Food and Drug Administration ; means the United States Federal Food, Drug, and Co smetic Act, 21 USC § § 301 et seq . ; has the meaning specified in Section 5.1(d ) ; means the department of the Canadian Government known as Health Canada and includes, among other relevant branches, the Therapeutic Products Direct orate and the Health Products and Food Branch Inspectorate ; has the meaning specified in Section 10.5 ; has the meaning specified in Section 10.5 ; May 18, 2020 Manufacturing Services Agreement between [COMPANY] and [COMPANY], Inc