definiens: means, with respect to a Licensed Product, any product that ( a ) is sold by a ThirdParty that is not a licensee or Sublicensee of OnCore or its Affiliates, or any of their licensees or Sublicensees, ( b)contains the Licensed Compound as an active ingredient, and ( c ) is approved in reliance, in whole or in part, on theprior approval ( or on safety or efficacy data submitted in support of the prior approval ) of such Licensed Product asdetermined by the applicable Regulatory Authority, including any product authorized for sale ( i ) in the U.S. pursuant toSection 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 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 ( iii ) in any other country or jurisdiction pursuant to all equivalents of suchprovisions, including any amendments and successor statutes with respect to the subsections ( i ) through ( iii ) thereto