definiens: means, with respect to a Licensed Product, any product that ( i ) is sold by a ThirdParty that is not a licensee or Sublicensee of [COMPANY] or its Affiliates, or any of their licensees or Sublicensees, undera Drug Approval Application granted by a Regulatory Authority to a Third Party ; ( ii ) contains the Licensed Compoundas an active ingredient ; and ( iii ) is approved in reliance, in whole or in part, on the prior approval ( or on safety orefficacy data submitted in support of the prior approval ) of such Licensed Product as determined by the applicableRegulatory Authority, including any product authorized for sale ( A ) in the U.S. pursuant to Section 505(b)(2 ) orSection 505(j ) of the Act ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respectively ), ( B ) in the EU pursuant to a provisionof Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC as amended ( including an application underArticle 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such provision ), or(C ) in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments andsuccessor statutes with respect to the subsections ( A ) through ( C ) thereto . A Licensed Product licensed or producedby [COMPANY] ( i.e., an authorized generic product ) will not constitute a Generic Product