definiens: means, with respect to any Product in any country inthe Territory, the date of the first sale, transfer or disposition by [COMPANY], an Affiliate of [COMPANY] orSublicensee, to a Third Party in that country after Marketing Authorization for the Product hasbeen received in that country ; provided that the following shall not constitute a First CommercialSale : ( a ) any sale, transfer or disposition of a Product at no more than a de minimis charge foracademic research, preclinical, clinical, or regulatory purposes ; ( b ) any sale, transfer ordisposition of a Product in connection with any patient assistance programs or for a bona fidecharitable purpose, including compassionate use or or to physicians orhospitals for promotional purposes ( including free samples to a level and in an amount which iscustomary in the industry or which is reasonably proportional to the market for such Product ) ; or(c ) any sale, transfer or disposition of a Product for use in Clinical Trials, pre - clinical studies orother Research or Development activities . shall have correlativemeaning . For purposes of the definition of only, these definitions shallapply to a Competing Generic as if it were a Product under this Section 1.65 ( and subject toadjusting the references from to the applicable Third Party ), mutatis mutandis