definiens: means, with respect to any Product, any pharmaceutical product that : ( a ) issold by a Third Party under a Regulatory Approval granted by a Regulatory Authority to such Third Party, which Third Party is not a licensee or sublicensee of HGS or its Affiliates, or any of their licensees orsublicensees, and has not obtained such Product from a chain of distribution including HGS or any of itsAffiliates, licensees or sublicensees or further sublicensees ; ( b ) contains the Compound applicable to suchProduct as an Active Ingredient ; and ( c ) is approved as a biologics equivalent of an A / B rated generics inreliance, in whole or in part, on the prior approval of such Product as determined by the applicableRegulatory Authority . does not include any Product licensed or produced by HGS orany of its Affiliates or sublicensees ( i.e