definiens: means in a particular c ountry with respect to a Product, any pharmaceutica l product that : ( A ) ( a ) has received all necessary ap provals by the applicable Regulatory Authorities in such country to market and sell such product as a pharmaceutical product ; ( b ) is marketed or sold by a Third Party that has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor of Apollo or any of its Affiliates, licensees or sublicensees with respect to such product ; and ( c ) is approved as a or or similar designatio n by the Regulatory Authorities in such country of such Product, with respect to which such Product is the for use in such country pursua nt to an expedited regulatory approval process governing app roval of generic biologics based on the then - curren t standards for regulatory approval in such country ( e.g., any CFDA equivalent to the Biologics Price Competition and Innovation Act of 2009 or an equivalent under forei gn law ) and where such regulatory approval was base d in significant part upon clinical data generated by Ap ollo ( or its Affiliate or Sublicensee ) with respect to such Product, or ( B ) is a product including one or more DNA plasm ids with greater than 90 % homology ( as measured by amino acid identity for the antigen coded for ) to the DNA plasmids included in VGX-3100 that is commercializ ed in the Field and in the Territory