definiens: means, with respect to a Product and country, any pharmaceutical product that ( a ) issold by a Third Party under a Regulatory Approval A pplication granted by a Regulatory Authority to suc h Third Party, which Third Party is not a licensee or Sublicensee of a Party or its Affiliates, or any of their licen sees orSublicensees, and has not obtained such Product fro m a chain of distribution including a Party, its Af filiates or any oftheir licensees or Sublicensees, ( b ) contains the a pplicable Licensed Compound as an active pharmaceut icalingredient, and ( c ) is approved in reliance, in who le or in part, on the prior approval of such Produc t as determined bythe applicable Regulatory Authority ( pursuant to 21 U.S.C. 355(b)(2 ), 21 U.S.C. 355(j ), a separate Reg ulatory ApprovalApplication, compendia listing, other drug approval application or otherwise, including foreign equiva lents of theforegoing ) . A Product licensed or produced by one o f the Parties or their respective Affiliates ( i.e., an authorizedgeneric product ) will not constitute a Generic Prod uct