definiens: has the meaning specified in Appendix 3 ; has the meaning specified in Section 5.1(a ) ; means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, asset out in this Agreement, for the manufacture of Product for distribution in the Territory ; means the facility of Patheon located at [ * * ] where the Manufacturing Services will be performed ; has the meaning specified in Section 2.1 ; means, for each manufacturing campaign ordered, the minimum number of units or batches of a Product thatClient must purchase, as set out in Appendix 1 ; has the meaning specified in Section 5.2(b ) ; [ * * ] ; Month DD, 20YYManufacturing Services Agreement between Patheon and AkebiaConfidentialPage 4 of 33 means Intellectual Property generated or derived by Patheon or its Aﬃliates before performing anyManufacturing Services, developed by Patheon while performing the Manufacturing Services, or otherwise generated or derived by Patheon inits business, which Intellectual Property is not speciﬁc to, or dependent upon, the Product including, without limitation, Inventions andIntellectual Property which may apply to manufacturing processes or the formulation or development of drug products or drug delivery systemsunrelated to the specific requirements of the Product ; means the fees to be charged by Patheon for:[**]as set out in Appendix 1 ; means the agreed ﬁle for the Product which contains documents relating to the Product, including, withoutlimitation : ( a)the Specifications ( b)quality control testing methods for API and Components ; ( c)any storage requirements for the API, Components, or Product ; ( d)all environmental, health and safety information for the Product including material safety data sheets ; and ( e)the finished Product quality control testing methods ; means a product listed in Appendix 1 of this Agreement ; has the meaning specified in Section 6.1(a ) ; means a separate agreement that sets out the quality assurance standards for the Manufacturing Services ; 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 other foreign regulatory agencies competent to grant marketingapprovals for pharmaceutical or biopharmaceutical products, including the Products, in the Territory ; Month DD, 20YYManufacturing Services Agreement between Patheon and AkebiaConfidentialPage 5 of 33 means in relation to each batch of Product the scheduled date by which the Product will be released by Patheon ’s qualitydepartment ( by conﬁrmation or certiﬁcation ) and conﬁrmed by Client ’s quality department, as agreed in the Quality Agreement, and madeavailable for shipment ; means, a party ’s directors, oﬃcers, employees, advisers, agents, consultants, subcontractors, service partners, legalrepresentatives, or other professional advisors ; has the meaning specified in Section 5.1(b ) ; means the ﬁle for the Product, which is approved by Client in accordance with the procedures listed in this Agreement andthe Quality Agreement including, without limitation : ( a)specifications for API and Components ; ( b)manufacturing specifications, directions, and processes ; ( c)all environmental, health and safety information for each Product including material safety data sheets ; and ( d)the finished Product specifications, packaging specifications and shipping requirements for each Product;all as updated, amended and revised from time to time in accordance with the terms of this Agreement and the Quality Agreement ; has the meaning specified in Section 13.17 ; means worldwide ; means the Intellectual Property of any third party ; means, in the ﬁrst year of this Agreement, the time from the Eﬀective Date up to and including December 31 of the same calendaryear, and after that will mean a calendar year