definiens: means, with respect to a Licensed Product in a particular country, any pharmaceutical product that : ( a ) has received all necessary approvals by the applicable Regulatory Authorities in such country to market and sell such product as a pharmaceutica l product, including all required pricing and reimbursement approvals ; ( 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 Five Prime or Zai or any of their r espective Affiliates, licensees or sublicensees with respect to such Licensed Product ; and ( c ) is approved as ( i ) a ( in the United States ) of such Licensed Product, ( ii ) a ( in the EU ) with respect to whic h such Licensed Product is the, or ( iii ) if not in the US or EU, the foreign equivalent of a or of such Licensed Product ; in each case for use in such country pursuant to an expedited regulatory approval process governing approval of generic biologics based on the then -current standards for regulatory approval in such country ( e.g., the Biologics Price Competition and Innovation Act of 2009 or an equivalent under foreign law ) and where such regulatory approval was based in significant part upon clinical data generated by Five Prime, Zai or their respective Affiliates or sublicensees with respect to such Licensed Product