definiens: means, with respect to the Product in a given country, a product sold in such country by aThird Party ( other than a sublicensee of KHK or any other Third Party authorized to sell such product by, or otherwisein the chain of distribution of, KHK or a KHK Affiliate or Sublicensee ) that ( a ) contains the same active ingredient(s)as the Product, or any base form, salt form, prodrug form, ester, ether, isomer, crystalline polymorph, hydrate orsolvate of such active ingredients ( but no more pharmaceutically active ingredients than is contained in the Product),and ( b ) is approved or registered for use in such country pursuant to any drug approval process based solely on(A ) ( x ) reference to a Regulatory Approval for such Product held by KHK, Syndax, or one of their respective Affiliatesor licensees, whether in such country or in another country, and/or ( y ) reference to other publicly available clinical datawith respect to such Product generated by KHK, Syndax, or one of their respective Affiliates or licensees, and ( B ) ademonstration of bioequivalence to such Product