1.11 “Calendar Year” means the period beginning on the Closing Date and ending on December 31 of the calendar year in which the Closing Date falls, and thereafter each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, that, the final Calendar Year shall end on the last day of the Term.
1.12 “cGMP” means applicable current Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Union Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the International Conference on Harmonization’s Q7 guidelines, and (d) the Applicable Laws in any relevant country or region corresponding to (a) through (c) above, each as may be amended and applicable from time to time.
1.13 “Clinical Data” means any and all data (together with all clinical trial reports and the results of analyses thereof) derived or generated in any Clinical Trial conducted by or on behalf of a Party or its Affiliates, the Ex-Territory Partner, or (with respect to Jazz) sublicensees.
1.14 “Clinical Trial” means any human clinical trial of a Licensed Product in the Field.
1.15 “Closing Date” means November 28, 2022.
1.16 “Combination Product” means a Licensed Product that comprises the Licensed Antibody, co-formulated, co-packaged or otherwise combined with one or more other Active Ingredients (each, an “Additional Active”) and sold for a single price.
1.17 “Commercialization” or “Commercialize” means any and all activities directed to the offering for sale and sale of Licensed Product, including (a) marketing, promoting, advertising, exhibiting, distributing, detailing, selling (and offering for sale or contracting to sell) or otherwise commercially exploiting a Licensed Product in the Field in the Territory (including importing and exporting activities in connection therewith); (b) order processing, handling of returns and recalls, booking of sales and transporting such Licensed Product for commercial sale; (c) the conduct of any post-approval Clinical Trials involving such Licensed Product; (d) interacting with Regulatory Authorities regarding the above; and (e) seeking and obtaining pricing approvals and reimbursement approvals (as applicable) for that Licensed Product in the Territory. For clarity, Commercialization does not include manufacture of Licensed Product.
1.18 “Commercially Reasonable Efforts” means [***].
1.19 “Companion Diagnostic” means companion or complementary diagnostic products to be used in connection with Licensed Products.
1.20 “Competing Product” means, with respect to Jazz, a Jazz Competing Product, and with respect to Zymeworks, a Zymeworks Competing Product.
1.21 “Confidential Information” of a Party (a “Disclosing Party”) means, subject to Section 10.2, all Know-How, which is generated by or on behalf of such Disclosing Party under this Agreement or any and any other information, including technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information, that is disclosed by a Disclosing Party or its
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