definiens: means, with respect to an S PC-3649 Product in a country in the Territory, the first sale, transfer or disposition for value b y Santaris, its Affiliates or Sublicensees to an en d userof an SPC-3649 Product in such country ; provided, t hat, the following shall not constitute a FirstCommercial Sale : ( a ) any sale to an Affiliate, Foun ding Company or Sublicensee unless the Affiliate, Founding Company or Sublicensee is the last entity in the distribution chain the SPC-3649 Product,(b ) any use of SPC-3649 or an SPC-3649 Product in C linical Studies, pre - clinical studies or otherresearch or development activities, or disposal or transfer of SPC-3649 or an SPC-3649 Product for abona fide charitable purpose, ( c ) compassionate use, ( d ) so called and and ( e ) use under the ATU system in France and/or the International Pharmi system inEurope