definiens: means, with respect to a Licensed Product in a pa rticular country in the Territory, any pharmaceutical product that : ( a ) has received all necessary approvals by the applicable Regulatory Authorities in such country to market and sell such product as a pharmaceutical product, including any and all required pricing and reimbursement approvals ; ( b ) i s marketed or sold in the Field by a Third Party th at has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor of Zymewo rks or [COMPANY] or any of their respective Affiliates, licensees or sublicensees with respect to such Licensed Product ; and ( c ) is approved as ( i ) a or ( in the United States ) of such Licensed Product, ( ii ) a ( in the EU ) with resp ect to which such Licensed Product is the, or ( iii ) if not in the US or EU, the fore ign equivalent of a or or of such Licensed Produc t ; in each case for use in such country pursuant to an expedited regulatory approval process governing approval of g eneric biologics based on the then - current standard s for regulatory approval in such country ( e.g., the Biologics Price Competition and Innovation Ac t of 2009 or an equivalent under foreign law ) and where such regula tory approval was based in significant part upon Cl inical Data generated by [COMPANY], [COMPANY] or their respective Affiliates or sublicensees with respect to such Li censed Product . For purposes of clarity, such a pharmaceut ical product will be deemed to be Biosimilar Produc t for purposes of this definition if a Licensed Product i s used as the reference product in the 1 Competitive Information – Technical Information