definiens: means, with respect to a Licensed Product and a c ountry in the Territory, a pharmaceutical product that ( a ) contains the same a ctive pharmaceutical ingredients ( and no other acti ve pharmaceutical ingredients ) as such Licensed Produc t or any base form, salt form, pro - drug form, ester, ether, isomer, crystalline polymorph, hydrate or solvate o f such active pharmaceutical ingredients, ( b ) is ap proved by the applicable Regulatory Authority in such country bas ed on reference to data contained in an earlier Reg ulatory Approval for such Licensed Product, and ( c ) is sold by a Third Party that is not a Sublicensee and suc h Third Party did not purchase such product or its active pharmac eutical ingredients from Licensee or its Affiliates or Sublicensees . With respect to a Licensed Product th at is a Combination Product, a Generic Product must, for purposes of this paragraph, contain as active pharm aceutical ingredients the same 5 combined active pharmaceutical ingredients as such Licensed Product, or any salt, ester, metabolite, o r pro - drug thereof, and meet the conditions defined in ( b ) and ( c ) above