definiens: means, with respect to an SPC-3649 Product in a c ountry in the Territory, the first sale, transfer or disposition for value by [COMPANY], its Affil iates or Sublicensees to an end user of an SPC-3649 Product in such country;provided, that, the following shall not constitute a First Commer cial Sale : ( a ) any sale to an Affiliate, Founding C ompany orSublicensee unless the Affiliate, Founding Company or Sublicensee is the last entity in the distributi on chain the SPC-3649Product, ( b ) any use of SPC-3649 or an SPC-3649 Pro duct in Clinical Studies, pre - clinical studies or o ther research ordevelopment activities, or disposal or transfer of SPC-3649 or an SPC-3649 Product for a bona fide cha ritable purpose,(c ) compassionate use, ( d ) so called and and ( e ) use unde r the ATU system inFrance and/or the International Pharmi system in Eu rope