definiens: means, with respect to a Licensed Product, any productthat ( a ) is sold by a Third Party that is not a licensee or Sublicensee of [COMPANY] or its Affiliates, or any of their licenseesor Sublicensees, under a Regulatory Marketing Approval granted by a Regulatory Authority to a Third Party ; ( b ) isapproved for one or more indications that are the same ( or substantially the same ) as one or more of the indicationsfor which the Licensed Product is approved ; and ( c ) is approved 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 Licensed Product as determined bythe applicable Regulatory Authority, including any product authorized for sale in the U.S. pursuant to 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 the European Union pursuantto a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC as amended ( including anapplication under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on anysuch provision ), or in any other country or jurisdiction pursuant to all equivalents of such provisions