definiens: means, with respect to a Licensed Product, a product sold by a Third Party in the Territory that(a ) contains buprenorphine as its sole API, ( b ) has been declared a bioequivalent of such Licensed Product pursuantto section C.08.004(4 ) of the Canadian Food and Drug Regulations or any successor legislation or regulation thereto, as stated on the applicable Notice of Compliance, ( c ) is approved for use for one or more of the same clinicalindications approved for such Licensed Product under an abbreviated new drug submission submitted pursuant tosection C.08.002.1 of the Canadian Food and Drug Regulations or any successor legislation or regulation thereto inwhich such Licensed Product is the reference listed drug, ( d ) is freely substitutable in the provinces of Ontario andQuebec by the pharmacist for such Licensed Product when filling a prescription written for such Licensed Productwithout having to seek authorization to do so from the physician writing such prescription, and ( e ) is not sold pursuantto a sublicense granted under this Agreement to such Third Party by Purdue, its Affiliates, or Sublicensees withrespect to such Licensed Product ( i.e., is not an ) or any rights related thereto