definiens: means, on a country by country basis with respect to a Product, any generic product such as a product that contains the Compound as an active ingredient ; and is approved in reliance, in whole or in part, on the prior approval ( or on safety or efficacy data submitted in support of the prior approval ) of such Product as determined by the applicable Regulatory Authority, including any product authorized for sale ( i ) in the U.S. pursuant to Section 505(b)(2 ) or Section 505(j ) of the FFDCA ( 21 U .S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respectively ), ( ii ) in the E.U. pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament and Council Regulat ion ( EC ) No 726/2004 that relies for its content on any such provision ), or ( iii ) in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the subsections ( i ) throu gh ( iii ) thereto . A Product marketed under the same Drug Approval Application as that of BII or any of its Affiliates but with the same or different trade name ( i.e., commonly known as an authorized generic product ) will not constitute a Generic Product