definiens: means, with respect to a particular Product in a country, a pharmaceutical productthat ( a ) contains an analytically comparable or identical active ingredient(s ) as such Product, ( b ) contains a non - natural amino acid, ( c ) is approved for use in such country pursuant to a regulatory approval process governingapproval of generic, interchangeable or biosimilar biologics based on the then - applicable standards for regulatoryapproval in such country, whether or not such regulatory approval was based in whole or in part upon clinical datagenerated by the Parties pursuant to this Agreement or was obtained using some other type of abbreviated orexpedited approval process and ( d ) is sold in the same country as such Product by any Third Party that is not aSublicensee of [COMPANY] or its Affiliates and did not purchase such product in a chain of distribution that included any ofBMS or any of its Affiliates or its Sublicensees