definiens: means, as applicable, all current good Manufacturin g practices and standards relating to the manufacture of chemicals, intermediates, bulk produ cts and finished pharmaceutical or biologic products for human use ( as appropriate ) as required by : ( a ) Parts 210 and 211 of Title 21 of the United States ’ Code of Federal Regulations ; ( b ) EC Directive 2003/94 / EC together with guidance in Volume 4 ( ) of the “ Rules Governing Medicinal Products in the European Union ) ( as the same may be amended from time to time ) ; ( c ) Division 2 of Part C of the Food and Drug Regulations ( Canada ) ; ( d ) Law 9782 of 26 th January 1999 and subsequent resolutions . ( Brazil ) ; and ( e ) The equivalent Law in any other relevant country, - 6 - Master Manufacturing Services Agreement together with the latest Health Canada, FDA and EMA guidance documents pertaining to Manufacturing and quality control practice, all as updated, amended and revised from time to time and, in each case, as applicable to the relevant Manufac turing Site or the Product or both in accordance wi th the relevant Product Agreement ; means Intellectual Property generated or derived b y Client or its Affiliates before entering into this Agreement, or by [COMPANY] while performing any Manufacturing Services or otherwise generated or derived by Pathe on in its business which Intellectual Property is specific to, or dependent upon, Client ’s Active Mat erial or Product ; has the meaning specified in Section 8.3(a)(vi ) ; means those Components to be supplied by Client or that have been supplied by Client ; means, with respect to the endeavours ( including f inancial spend ) to be expended by a Party to achieve any obj ective, all reasonable, diligent commercial efforts to accomplish such objective that a person with operat ions of a similar scale and standing in the pharmaceutical industry would normally use when con ducting an on - going business for its own benefit to accomplish a similar objective under similar cir cumstances ; means, collectively, all packaging components, raw materials, ingredients, tangible biological materials, cells, reference standards, a ssays and media, intermediates, excipients, process ing aids and other materials ( including labels, product inserts and other labelling for the Products ) requ ired to Manufacture the Products in accordance with the Specifications, other than any Active Materials ; has the meaning specified in Section 11.1 ; means Product that complies in all respects, at th e time of Delivery to the Client in accordance with this Agreement with the a pplicable Specifications ; cGMPs ; Firm Order(s ) ; Manufacturing Licences ; Marketing Authorisations or INDs, the quality requirements set out in the Quality Agreement ; Applicable Laws, and all other r epresentations and warranties regarding the Product and the Manufacturing Services in this Agre ement ; means the Price for performing the Manufacturing S ervices excluding the cost of Components ( including any Client Supplied Component s ) and the cost of Active Materials ; has the meaning specified in Section 7.8(c ) ; has the meaning specified in Section 2.1(f ) ; means Product that is not Conforming Product