definiens: means, with respect to a Licensed Product, ( a ) an y product th at is sold by a Third Party under a Regulatory Approval granted by a Regu latory Authority to a Third Party, which Third Party has not obtained the right to market or sell such product from AZ ( including as a Sublicensee, subcontractor, or Distributor of AZ or any of its Affiliates ) and [ * * * ] and ( b ) is appr oved in reliance, in whole or in part, on the prior approval ( or on data supporting safety or efficacy data submitted in su pport of the prior approval ) of such Licensed Product as determined by the applic able Regulatory Authority, including but not limited to any product authorized for sale ( i ) in the U.S. pursuant to Section 505(b ) ( 2 ) or Section 505(j ) of the FD&C Act ( 21 U.S.C. 355(b ) ( 2 ) and 21 U.S.C. 355(j ), respectively ), ( ii ) in th e E.U. pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83 / EC as amended ( including an application under Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such pr ovision ), or ( iii ) i n any other country or jurisdiction pursuant to the equivalents of such provisions, inc luding any amendments and successor statutes with respect to the subsections ( i ) through ( iii )