definiens: 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 regulatoryagencies with the legal authority to grant marketing approvals for pharmaceutical or biopharmaceuticalproducts, including the Products, in the applicable country or jurisdiction in the Territory ; means, in relation to a particular batch of Product manufactured under a particular ProductAgreement, the scheduled date by which the Product will be released by [COMPANY] ’s quality department ( byconfirmation or certification ) as agreed in the Quality Agreement and made available for shipment, and asconfirmed by [COMPANY] in a Firm Order ; means, as to a Party, all the directors, officers, employees, legal advisers, agents, consultants, subcontractors ( excluding the other Party and its Affiliates ), service partners, professionaladvisors, or legal representatives of such Party or its Affiliate ; has the meaning specified in Section 5.1(b ) ; has the meaning specified in Appendix 2 ; means, as to a particular Product, the geographic area described in the relevant ProductAgreement where such Product manufactured by [COMPANY] will be distributed by or on behalf of Client or itsAffiliate or licensees or distributors ; means the Intellectual Property of any third party ; has the meaning specified in Section 13.14 ; and means, with respect to this Agreement or a particular Product Agreement : ( a ) in the first year of thisAgreement or such Product Agreement, the time from the effective date of the applicable agreement up toand including December 31 of the same calendar year, and ( b ) after that will mean a calendar year