definiens: means, with respect to any Licensed Product in any country or region, the first sale of such Licensed Product, by or on behalf of Licensee ( including by any of its Affiliates or Sublicensees),in an arms - length transaction to a Third Party ( other than a Sublicensee ) for distribution, use, or consumption in suchcountry or region after receipt of Regulatory Approval for such Licensed Product in such country or region . For theavoidance of doubt, excludes any transfers of Licensed Product to Third Parties for testingpurposes, any expanded access program, any compassionate sales or use program ( including named patient programor single patient program ), or any indigent program ; provided that, in each case, such Licensed Product is provided atno charge and not sold in connection ( e.g., as a bundle or another type of direct or indirect bundling arrangement ) withany other product of Licensee, its Affiliates or Sublicensees in which consideration is charged for such LicensedProduct