definiens: means : ( a ) a business entity which owns, directly or ind irectly, a controlling interest in a party ; or ( b ) a business entity which is controlled by a pa rty, either directly or indirectly ; or ( c ) a business entity, the controlling interest of whic h is directly or indirectly common to the majority ownership of a party ; For this definition, means the lawful rig ht to determine ( by ownership of shares or otherwis e ) the election of the majority of directors ( or equiv alent managers ) of a business entity ; means, for the purpose of the Price, [COMPANY] ’s as sumed minimum volume of Product to be manufactured in any Year as set out in the section of Schedule A of the applicable Product Agreement ; means the active materials listed in the applicab le Product Agreement ( references to or in documents forming part of this Agreement or of a Product Agreement will mean ) ; Master Manufacturing Services Agreement Page 4 of 35 means the value of the API for certain purposes o f this Agreement, as set out in the applicable Product Agreement ; means : ( i ) for [COMPANY], the Laws of the jurisdict ion where the Manufacturing Site is located ; and ( ii ) for Client and the Product, th e Laws of all jurisdictions where Product is manufactured, distributed, and marketed as these ar e agreed by the parties in the Product Agreement ; means any governmental or regulatory authority, d epartment, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal, with competent jurisdiction over a party, the Manufacturing Services, or the relevant Produ ct ( or its use ) ; means a day other than a Saturday, Sunday or a da y that is a statutory holiday in [COMPANY] ’s resident jurisdiction, Client ’s resident jurisdiction, or the jurisdiction where the Manufacturing Site is located ; means the separate agreement that the parties may enter into that addresses the rights and responsibilities of the pa rties regarding capital equipment and facility modifications that may be required to perform the M anufacturing Services under a particular Product Agreement ; means, as applicable, current good manufacturing practices as described in : ( a ) Parts 210 and 211 of Title 21 of the United S tates ' Code of Federal Regulations ; ( b ) Commission Directive ( EU ) 2017/1572 ( art . 2 ) ; and ( c ) Division 2 of Part C of the Food and Drug Reg ulations ( Canada ) ; together with current final industry - accepted Healt h Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control pra ctice, all as updated, amended and revised from tim e to time ; means Intellectual Property ( i ) generated, acquir ed or derived by Client, or any developments thereof generated, acquired or derived by Client, at any time separate and apart from the performance of Manufacturing Services, or ( ii ) by [COMPANY] while performing any Manufacturing Services which Intellectual Property is specific to, or dependent upon, the Product ; means those Components supplied or to be supplied by or on behalf of Client as identified in Schedule A of a Product Agreement ; means, collectively, all packaging components, ra w materials, ingredients, and other materials ( including labels, product inserts and ot her labelling for the Products ) required to manufac ture or package Product in accordance with the Processin g Instructions, other than the API ; has the meaning specified in Section 11.1 ; Master Manufacturing Services Agreement Page 5 of 35 means the Drug Enforcement Administration of the United States Department of Justice ; has the meaning specified in Section 6.1(a ) ; has the meaning specified in Section 11.1 ; means the European Medicines Agency ; means the United States Food and Drug Administrat ion ; has the meaning specified in Section 5.1(d ) ; means the department of the Canadian Government k nown as Health Canada and includes, among other relevant branches, the Therap eutic Products Directorate and the Health Products and Food Branch Inspectorate ; has the meaning specified in Section 8.1 ; includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade - names, In ventions, copyrights, industrial designs, trade secrets, and know how ; means information about any innovation, improveme nt, development, discovery, computer program, device, trade secret, method, process, tec hnique or the like, whether or not written or other wise fixed in any form or medium, regardless of the medi a on which it is contained and whether or not patentable or copyrightable ; means, at a point in time, all inventories of Com ponents and work - in - process under [COMPANY] ’s care or control used for the manufacture or packaging of Product ; means all laws, statutes, ordinances, regulations, rules, by - laws, judgments, decrees or orders of any Authority ; has the meaning specified in Appendix 4 ; has the meaning specified in Section 5.1(a ) ; means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set ou t in the relevant Product Agreement, for the manufacture of Product for distribution in the Terr itory ; means the facility identified in a Product Agreem ent where the Manufacturing Services will be performed ; has the meaning specified in Section 2.1 ; means, for each manufacturing campaign ordered, t he minimum number of units or batches of a Product that Client must p urchase, as set out in Schedule A of the applicable Product Agreement ; Master Manufacturing Services Agreement Page 6 of 35 has the meaning specified in Section 5.2(b ) ; means a business that derives greater than 50 % of its revenues from performing contract pharmaceutical or biopharmaceutical develo pment or commercial manufacturing services ; means Intellectual Property generated or derived by [COMPANY] or its Affiliates before performing any Manufacturing Serv ices, developed by [COMPANY] while performing the Manufacturing Services, or otherwise generated or d erived by [COMPANY] in its business which Intellectua l Property is not specific to, or dependent upon, the Product including, without limitation, Inventions and Intellectual Property which may apply to manufactur ing processes or the formulation or development of drug products or drug delivery systems unrelated to the specific requirements of the Product ; means the fees to be charged by [COMPANY] for : ( a ) performing the Manufacturing Services ; ( b ) the cost of Components ( other than Client - Sup plied Components ) ; and ( c ) any separate cost items and other fees, as set out in Schedule A of the applicable Product Agreement ; means the agreed file, for each Product, which co ntains documents relating to the Product, including, without limitation : ( a ) quality control testing methods for API and C omponents ; ( b ) manufacturing instructions, directions, and p rocesses ; ( c ) any storage requirements for the API, Compone nts, or Product ; ( d ) all environmental, health and safety information fo r the Product including material safety data sheets ; and ( e ) the finished Product quality control testing methods, packaging instr uctions and shipping requirements for the Product ; means a product listed in Schedule A of a Product Agreement ; means the agreement between [COMPANY] and Client ( o r their applicable Affiliates ) substantially in the form set out in Appendix 1 und er which [COMPANY] will perform Manufacturing Services ; has the meaning specified in Section 6.1(a ) ; means a separate agreement that sets out the qual ity assurance standards for the Manufacturing Services ; Master Manufacturing Services Agreement Page 7 of 35 has the meaning specified in Section 6.2(a ) ; has the meaning specified in Section 11.1 ; has the meaning specified in Section 7.5(a ) ; means the FDA, EMA, and Health Canada and any oth er foreign regulatory agencies competent to grant marketing approvals for pharmaceutical or biopharmaceutical products, including the Products, in the Territory ; means in relation to each batch of Product the sc heduled date by which the Product will be released by [COMPANY] ’s quality department ( by con firmation or certification ) as agreed in the Qualit y Agreement and made available for shipment, and as c onfirmed by [COMPANY] in a Firm Order ; means, a party ’s directors, officers, employees, advisers, agents, consultants, subcontractors, service partners or professional ad visors ; has the meaning specified in Section 5.1(b ) ; has the meaning specified in Appendix 2 ; means the geographic area described in a Product Agreement where Product manufactured by [COMPANY] will be distributed by or on behalf of C lient ; means the Intellectual Property of any third part y ; has the meaning specified in Section 13.14 ; and means in the first year of this Agreement or a Pr oduct Agreement, the time from the Effective Date up to and including December 31 of the same ca lendar year, and after that will mean a calendar year