definiens: means any pharmaceutical product that is distribu ted by a Third Party ( that is not licensed or otherwise permitted by KKC or its Affil iates or its Sublicensees ) in a country ( a ) under a Regulatory Approval approved by a Regulatory Authority in reli ance, in 9 Confidential EXECUTION VERSION whole or in part, on the Regulatory Approval for th e Product, including any product authorized for sal e ( i ) in the United States pursuant to Section 505(b)(2 ) or 505 ( j ) of the FD&C Act ( 21 U.S.C. 355(b)(2 ) and 355(j ), respectively ), ( ii ) in the EU pursuant to Article 1 0 of Directive 2001/83 / EC as amended, or ( iii ) in o ther countries in the Territories all equivalents of suc h provisions in ( i ) and ( ii ), and ( b ) which product ( i ) contains the same active pharmaceutical ingredient(s ) as the Pro duct, ( ii ) is approved based in significant part up on clinical data generated and used for obtaining Regulatory Ap proval of the Product and ( iii ) is approved for at least one of the same Indication(s ) as the Product in such count ry