definiens: means, with respect to a particular Product in th e Field, any product that ( a ) is sold by a Third Party that is not a Sublicensee of Company or its Affiliates, or any of their Sublicen sees, ( b ) contains a Compound as an active ingredient, an d ( c ) is approved in reliance, in whole or in part, on the prior approval ( or on safety or efficacy data submitted i n support of the prior approval ) of such Product as determined by the applicable Regulatory Authority, including a ny product authorized for sale ( i ) in the U.S. purs uant to Section 505(b)(2 ) or Section 505(j ) of the FFDCA ( 2 1 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respective ly ), ( ii ) in the European Union pursuant to a provision of Ar ticles 10, 10a or 10b of Parliament and Council Dir ective 2001/83 / EC as amended ( including an application und er Article 6.1 of Parliament and Council Regulation ( EC ) No 726/2004 that relies for its content on any such provision ), or ( iii ) in any other country or juris diction pursuant to all equivalents of such provisions, inc luding any amendments and successor statutes with r espect to the subsections ( i ) through ( iii ) thereto . A produc t produced by or on behalf of or authorized by Comp any, its Affiliates, or its Sublicensees will not constitute a Generic Product ( e.g., an authorized generic pro duct )