definiens: means, with respect to a Licensed Product, any product that ( i ) is sold by a Third Partythat is not a licensee or Sublicensee of [COMPANY] or its Affiliates, or any of their licensees or Sublicensees, under aDrug Approval Application granted by a Regulatory Authority to a Third Party, ( ii ) contains the Licensed Compound asan active ingredient, and ( iii ) is approved in reliance, in whole or in part, on the prior approval ( or on safety or efficacydata submitted in support of the prior approval ) of such Licensed Product as determined by the applicable RegulatoryAuthority, including any product authorized for sale ( a ) in the U.S. pursuant to Section 505(b)(2 ) or Section 505(j ) ofthe FFDCA ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respectively ), ( b ) in the E.U. pursuant to a provision of Articles10, 10a or 10b of Parliament and Council Directive 2001/83 / EC as amended ( including an application under Article 6.1of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such provision ), or ( c ) in anyother country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successorstatutes with respect to the subsections ( a ) through ( c ) thereto . A Licensed Product licensed or produced by AbbVieor one of its Affiliates ( i.e., an authorized generic product ) will not constitute a Generic Product