definiens: means, in a particular country wi th respect to a Product any pharmaceutical product that : ( 1 ) c ontains a compound that has the same active ingredi ent as the Resulting Compound in such Product ; ( 2 ) has receive d all necessary approvals by the applicable Regulat ory Authorities authorizing the marketing and sale of s uch product as a pharmaceutical product ; ( 3 ) is mar keted or sold by a Third Party that has not obtained the rig hts to market or sell such product as a licensee, s ublicensee or distributor of [COMPANY] or any of its Affiliates, licens ees or sublicensees with respect to such product ; a nd ( 4 ) is approved for use in such country pursuant to an abb reviated regulatory approval process governing appr oval of generic drug products based on the then - current sta ndards for regulatory approval in such country ( e.g., an abbreviated new drug application, or a relevant equ ivalent under foreign law ) and where such regulator y approval was based in significant part upon clinica l data generated by [COMPANY] ( or its Affiliate or Sublic ensee ) with respect to such Product, and ( B ) means in a - 54 - Table of Contents particular country with respect to a Product that c ontains a Resulting Compound, any pharmaceutical pr oduct that : ( 1 ) has received all necessary approvals by t he applicable Regulatory Authorities in such countr y to market and sell such product as a pharmaceutical product ; ( 2 ) is marketed or sold by a Third Party that has n ot obtained the rights to market or sell such product as a lice nsee, sublicensee or distributor of [COMPANY] or any of i ts Affiliates, licensees or sublicensees with respect to such prod uct ; and ( 3 ) is approved as a ( I ) ( in the U.S. ) of such Product, ( II ) as a ( in the European Union ) with respect to which such Product is the o r ( III ) if not the U.S. or European Union, as the f oreign equivalent of a or of such Product ; in each case ( ( 1)-(3 ) ), for use in such country pursuant to an abbreviated regu latory approval process governing approval of biosi milars 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 equiva lent under foreign law ) and where such regulatory a pproval was based in significant part upon clinical data ge nerated by [COMPANY] ( or its Affiliate or sublicensee ) wi th respect to such Product