definiens: means, with respect to the Product in a particular country, regulatory jurisdiction, orregion, any pharmaceutical product that ( a ) ( i ) contains the same APIs as the Product for the same route ofadministration as the Product and is approved by the Regulatory Authority in such country, regulatory jurisdiction, orregion ( for an Indication for which the Product obtained Regulatory Approval from the applicable Regulatory Authorityin such country, regulatory jurisdiction or region ) ; or ( ii ) is approved by the Regulatory Authority in such country, regulatory jurisdiction or region as a substitutable generic for the Product ( for an Indication for which the Productobtained Regulatory Approval from the applicable Regulatory Authority in such country, region or jurisdiction ) inaccordance with applicable regulations of such Regulatory Authority ; and ( b ) is sold in such country, regulatoryjurisdiction or region by [COMPANY], its Affiliates or a Third Party ( excluding any Third Party that is a Sublicensee)who did not purchase such pharmaceutical product in a chain of distribution that included any of VIT or its Affiliates orSublicensees