definiens: means, with respect to a Product, any pharmaceutical product that ( a ) is sold by a Third Party that is not a licensee or sublicensee of [COMPANY] or its Affiliates, or any of their licensees or sublicensees ; ( b ) contains the same active pharmaceutical ingredient as such Product ; and ( c ) is approve d 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 FD&C Act ( 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 ( in cluding an application under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such provision ), or ( iii ) in any other country or jurisdiction pursuant to any equivalent of such provisions