definiens: means, in a particular country with respect to a particular Licensed Product, any biopharmaceutical product that : ( a ) has receive d all necessary approvals by the applicable Regulat ory Authorities in such country to market and sell such product as a biopharmaceutical product ; ( b ) is mar keted or sold by a Third Party that either ( i ) has not obtained t he rights to market or sell such product as a Subli censee or as a distributor of Kite or any of its Affiliates or Sub licensees, in each case with respect to such Licens ed Product or ( ii ) received the right to market or sell such prod uct pursuant to a license or settlement, in each ca se in connection with litigation with Kite, its Affiliate or a Subli censee under the Biologics Price Competition and In novation Act of 2009 or an equivalent under foreign law ; and ( c ) is approved as ( i ) a ( in the United S tates ) of such Licensed Product, ( ii ) a ( in the EU ) with respect to which such Licensed Product is the, or ( i ii ) if not in the US or EU, the foreign equivalent of a or of such L icensed Product ; in each case for use in such count ry pursuant to an expedited regulatory approval process governi ng approval of generic biologics based on the then- current standards for regulatory approval in such country ( e.g., the Biologics Price Competition and Innovatio n Act of 2009 or an equivalent under foreign law ) and where such regulatory approval was based in part upon cli nical data generated by a Party or any of its Affiliates, lice nsees or sublicensees with respect to such Licensed Product