definiens: means, with respect to aLicensed Product in a particular country, any pharmaceutical product that ( A)(1 ) contains at leastone of the same API as such Licensed Product and is approved by the Regulatory Authority insuch country for an indication for which such Licensed Product obtained Regulatory Approvalfrom the applicable Regulatory Authority in such jurisdiction ; or ( 2 ) is approved by the RegulatoryAuthority in such country as a substitutable generic for such Licensed Product, for an indicationfor which such Licensed Product obtained Regulatory Approval from the applicable RegulatoryAuthority in such country, on an expedited or abbreviated basis in a manner that relied on orincorporated data submitted by Licensee or its Affiliate or sublicensee in connection with theRegulatory Approval for the Licensed Product in such jurisdiction ; and ( B ) is sold in such countryby a Third Party that is not a sublicensee of Licensee and did not purchase such product in achain of distribution that included Licensee or its Affiliates or any sublicensees of Licensee