definiens: means, with respect to a Licensed Product in any countryin the Partner Territory, any pharmaceutical product that contains the Licensed Compound andthat- 4 - is distributed by a Third Party under a Marketing Approval approved by a Regulatory Authority inreliance, in whole or in part, on the prior approval ( or on safety or efficacy data submitted insupport of the prior approval ) of such Licensed Product, including any product authorized forsale in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and CouncilDirective 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament andCouncil Regulation ( EC ) No 726/2004 that relies for its content on any such provision ) or in anyother country or jurisdiction pursuant to all equivalents of such provisions ; provided, however, that a product licensed or produced by Partner or its Affiliates or Sublicensee(s ) ( i.e