definiens: means, with respect to a Product in a particular regulatoryjurisdiction, any pharmaceutical product that ( a ) ( i ) contains the same active pharmaceuticalingredients as such Product, in the same formulation and dosage form as such Product and for thesame route of administration as such Product and is approved by the Regulatory Authority in suchcountry ( for an indication for which such Product obtained Regulatory Approval from theapplicable Regulatory Authority in such jurisdiction ) ; or ( ii ) is approved by the Regulatory Authorityin such country as a substitutable generic for such Product ( for an indication for which suchProduct obtained Regulatory Approval from the applicable Regulatory Authority in suchjurisdiction ) on an expedited or abbreviated basis in a manner that relied on or incorporated datasubmitted by MTPC or its Affiliate or Sublicensee in connection with the Regulatory Approval forthe Product in such jurisdiction ; and ( b ) is sold in such jurisdiction by a Third Party that is not aSublicensee and did not purchase such product in a chain of distribution that included any ofMTPC or its Affiliates or Sublicensees