definiens: means in a particular country with respect to a Product that contains a Compoundthat is a protein or peptide, any pharmaceutical product that : ( a ) has received all necessary approvals by theapplicable Regulatory Authorities in such country to market and sell such product as a pharmaceutical product ; ( b ) ismarketed 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 [COMPANY] or any of its Affiliates, licensees or sublicensees with respect to such product ; and(c ) is approved as a ( i ) ( in the United States ) of such Product, ( ii ) as a ( in the EU ) with respect to which such Product is the or ( iii ) if not the US or EU, as the foreign equivalent of a or of such Product ; in each case foruse in such country pursuant to an expedited regulatory approval process governing approval of generic biologicsbased on the then - current standards for regulatory approval in such country ( e.g