definiens: shall mean, with respect to a Product, on a country - by - country basis, apharmaceutical product that : ( a ) is sold in a given country by a Third Party, other than Purchaser, any of its Affiliates, any Licensee, or any other Person in a chain of distribution originating fromPurchaser, any of its Affiliates or any Licensee ; ( b ) contains the same Compound ( and, if suchProduct is a fixed - dose combination that also contains any other active pharmaceuticalingredient that is not a Compound, the same other active ingredient(s ) ) as such Product in thesame dosage form as such Product ; and ( c ) has been approved for marketing by the relevantRegulatory Authority in such country ( or by the EMA, if applicable, in the case of an EU Country)in reliance on the Marketing Approval for such Product in such country ( or by the EMA, ifapplicable, in the case of an EU Country ), including any such pharmaceutical product that hasbeen approved for marketing ( i ) in the United States, pursuant to Section 505(b)(2 ) or Section505(j ) of the Act ( 21 U.S.C. § 355(b)(2 ) or 21 U.S.C. § 355(j ), respectively ), ( ii ) in the EU or an EUCountry, as a pursuant to Article 10 of Parliament and CouncilDirective 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament andCouncil Regulation ( EC ) No 726/20043that relies for its content on any such provision ), or ( iii ) in any other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the approvalof such pharmaceutical product is based on reference to the Marketing Approval for such Productin such country or jurisdiction and a demonstration of bio - equivalence to such Product and whichmay be substituted for the Product without any action by the physician or health care practitioner