definiens: means in a particular country with respect to a Licensed Productthat contains a Licensed Antibody, any pharmaceutical product that : ( a ) has received all necessary approvals bythe applicable Regulatory Authorities in such country to market and sell such product as a pharmaceuticalproduct ; ( b ) is marketed or sold by a Third Party that has not obtained the rights to market or sell such product asa licensee, sublicensee or distributor of [COMPANY] or any of its Affiliates, licensees or sublicensees with respect tosuch product ; and ( c ) is approved as ( i ) a ( in the United States ) of such Licensed Product, ( ii ) a ( in the EU ) with respect to which 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 expeditedregulatory approval process governing approval of generic biologics based on the then - current standards forregulatory approval in such country ( e.g