definiens: means, on a country - by - country basis, with respect to a Licensed Product, any product that ( a ) has received allRegulatory Approvals in such country to market and sell such product as a pharmaceutical product ; ( b ) is marketed or sold by a Third Party that has notobtained the rights to market or sell such product as a licensee, sublicensee or distributor of [COMPANY] or any of its Affiliates, licensees or sublicensees withrespect to such product ; and ( c ) is approved ( i ) as a or ( in the United States ) of such Licensed Product, ( ii ) as a ( in the EU ) with respect to which such Licensed Product is the or ( iii ) if not the US or EU, asthe foreign equivalent of a or of such Licensed Product . Biosimilar Products do notinclude any Licensed Products licensed, marketed, sold, manufactured, or produced by [COMPANY], its Affiliates or Sublicensees