definiens: means with respect to a Licensed Product, any pharmaceutical product that ( a ) is sold by a Third Party that is not aSublicensee ( or any of its Aﬃliates ) under a Marketing Authorisation granted by a Regulatory Authority to a Third Party ; ( b ) contains as anactive ingredient the same compound as a Licensed Product ; and ( c ) ( i ) in the United States, is approved in reliance on the prior approval ofsuch Licensed Product as determined by the applicable Regulatory Authority in the United States pursuant to Section 505(j ) of the UnitedStates Food, Drug and Cosmetic Act ( 21 U.S.C. 355(j ) ), ( ii ) in the EEA, is authorised as a as deﬁned in Article 10(2)(b ) of Parliamentand Council Directive 2001/83 / EC as amended, or ( iii ) in any other country or jurisdiction, is approved pursuant to all equivalents of theprovision described in ( c)(i ) or ( c)(ii ) above . A Licensed Product licensed or produced by a Sublicensee in compliance with its sublicenseagreement will not constitute a Generic Product