definiens: means, with respect to any Product, any product that ( a ) is sold by a third party ( i.e., other thanRedHill or its Affiliates ) that is not a Sublicensee of RedHill, under a Regulatory Approval granted by a RegulatoryAuthority to a third party ; ( b ) is approved for one or more indications that are the same ( or substantially the same ) asone or more of the indications for which the Product is approved ; and ( c ) is approved in reliance, in whole or in part, onthe prior approval ( or on safety or efficacy data submitted in support of the prior approval ) of the Product asdetermined by the applicable Regulatory Authority, including any product authorized for sale in the U.S. pursuantto Section 505(b)(2 ) or Section 505(j ) of the Act ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respectively ), in theEuropean Union pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC asamended ( including an application under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that reliesfor its content on any such provision ), or in any other country or jurisdiction pursuant to all equivalents of suchprovisions . A product licensed or produced by RedHill or its Affiliates ( i.e., an authorized generic product ) will notconstitute a Generic Product