definiens: ) is an Affiliate of [COMPANY] under this Agreement ; means, for the purpose of the Price, Patheon ’s assumed volume of Product to be manufactured in any Year as set out inthe section of Appendix 1 ; means the active pharmaceutical ingredient for vadadustat ( references to or indocuments forming part of this Agreement will mean ) ; [ * * ] means : ( a ) for Patheon, the Laws of the jurisdiction where the Manufacturing Site is located ; and ( b ) for Client and theProduct, the Laws of all jurisdictions where Product is manufactured, distributed, marketed and sold as these are agreed by the parties in thisAgreement ; means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or othersimilar body, whether federal, state, provincial, county or municipal, with competent jurisdiction over a party, the Manufacturing Services, orthe relevant Product ( or its use ) ; means a day other than a Saturday, Sunday or a day that is a statutory holiday in Patheon ’s resident jurisdiction, Client’sresident jurisdiction, or the jurisdiction where the Manufacturing Site is located ; Month DD, 20YYManufacturing Services Agreement between Patheon and AkebiaConfidentialPage 2 of 33 means the separate agreement that the parties may enter into that addresses the rights andresponsibilities of the parties regarding capital equipment and facility modiﬁcations that may be required to perform the ManufacturingServices under this Agreement ; means, as applicable, current good manufacturing practices as described in : ( a)Parts 210 and 211 of Title 21 of the United States ' Code of Federal Regulations ; ( b)Commission Directive ( EU ) 2017/1572 ( art . 2 ) ; and ( c)Division 2 of Part C of the Food and Drug Regulations ( Canada);together with current ﬁnal industry - accepted Health Canada, FDA and EMA guidance documents pertaining to manufacturing and qualitycontrol practice, all as updated, amended and revised from time to time ; means Intellectual Property generated or derived by Client, or by Patheon while performing any ManufacturingServices 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 Appendix 1 ; means, collectively, all packaging components, raw materials, ingredients, and other materials ( including labels, productinserts and other labelling for the Products ) required to manufacture or package Product in accordance with the Processing Instructions, otherthan the API ; has the meaning specified in Section 11.1 ; 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 date of last signature of the parties executing this Agreement ; means the European Medicines Agency ; means the United States Food and Drug Administration ; has the meaning specified in Section 5.1(d ) ; Month DD, 20YYManufacturing Services Agreement between Patheon and AkebiaConfidentialPage 3 of 33 means an government, or other acts such as war, riot, crime, or strike, earthquake, hurricane, tornado orflooding, caused by facts or circumstances which a party could not reasonably foresee or which, if foreseeable, they could not reasonablyavoid [ * * ] ; means the department of the Canadian Government known as Health Canada and includes, among other relevantbranches, the Therapeutic 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, Inventions, copyrights, industrial designs, trade secrets, and know how ; means information about any innovation, improvement, development, discovery, computer program, device, trade secret, method, process, technique or the like, whether or not written or otherwise ﬁxed in any form or medium, regardless of the media on which it iscontained and whether or not patentable or copyrightable that are conceived, discovered, invented, developed, created, made or reduced topractice during the provision of the Manufacturing Services ; means, at a point in time, all inventories of Components and work - in - process under Patheon ’s care or control used for themanufacture or packaging of Product ; [ * * ]