definiens: means Intellectual Property that does not constitute Client Intellectual Property and is ( i ) [ * * * ], or ( ii ) [ * * * ] ; means the fees to be charged by [COMPANY] for : ( a ) the Product as set out in Appendix 1 ; and ( b ) the cost of Components ( other than Client -Supplied Components ) as set out in Appendix 1 ; and ( c ) any separate cost items and other fees for services requested by Client and specif ically excluded from the cost of the Product, as may be subject to an additional written work order or written agreement that is expressly made subject to the terms and conditions of this Agreement ; means the agreed file, for the applicable strength of Product, which contains documents relating to the Product, including, without limitation : ( a ) quality control testing methods for API and Components ; ( b ) master batch, production and control records, manufacturing instructions, directions, and processes ; ( 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, packaging instructions and shipping requirements for the Product ; means the product listed in Appendix 1, in each case manufactured and packaged in accordance with the Processing Instructions and the Specifications ; has the meaning specified in Section 3.3 ; has the meaning specified in Section 6.1(b)(i ) ; 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 7.6(a ) ; means the FDA, EMA, and Health Canada and any other foreign regulator y agencies competent to grant marketing approvals for pharmaceutical or biopharmaceutical products, including the Products, in the Territory ; May 18, 2020 Manufacturing Services Agreement between [COMPANY] and [COMPANY], Inc