definiens: 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 United States ; means the Intellectual Property of any third part y ; and means in the first year of this Agreement, the ti me from the Effective Date up to and including December 31 of the same calendar year, and after th at will mean a calendar year