definiens: shall mean, with respect to a Licensed Product, a ny pharmaceutical product that : ( i ) is sold by a Third Party under a Drug Approval Application granted by a Regulatory Authority to su ch Third Party, which Third Party is not a licensee or Subli censee of Licensee or its Affiliates, or any of the ir licensees or sublicensees, and has not obtained such Licensed Pr oduct from a chain of distribution including Licens ee, its Affiliates or any of their licensees or sublicensee s, and ( ii ) contains the applicable Licensed Compou nd as an active pharmaceutical ingredient ; and ( iii ) is appr oved in reliance, in whole or in part, on the prior approval of such Licensed Product as determined by the applicab le Regulatory Authority ( pursuant to 21 U.S.C. 355 ( b)(2 ), an ANDA, a separate NDA, compendia listing, other d rug approval application or otherwise, including fo reign equivalents of the foregoing ) . A Licensed Product l icensed or produced by Licensee ( i.e., an authorized generic product ) will not constitute a Generic Product