definiens: means, with respect to a Product, any pharmaceuti cal product that : ( a ) is sold by a Third Party under a Drug Approval Application gra nted by a Regulatory Authority to such Third Party, which Third Party is not a licensee or sublicensee of one of the Parties or their Affiliates, or any of thei r licensees or sublicensees, and has not obtained such Product fro m a chain of distribution including one of the Part ies, its Affiliates or any of their licensees or sublicensee s, ( b ) contains the applicable New Collaboration Co mpound as an active pharmaceutical ingredient ( or the same ac tive moiety ) ; and ( c ) is approved in reliance, in w hole or in part, on the prior approval of such Product as dete rmined by the applicable Regulatory Authority ( purs uant to 21 U.S.C. 355(b)(2 ), an ANDA, a separate NDA, compendi a listing, other drug approval application or other wise, including foreign equivalents of the foregoing ) . A Product licensed or produced by one of the Parties ( i.e., an authorized generic product ) will not constitute a G eneric Product