definiens: means, with respect to a Product that is being so ld in a country or regulatory jurisdiction in the Territory ( the ), any biopharmaceutical product that ( a ) contains the same or ( as such term is used in 42 U.S .C. § 262(i)(2 ) or analogous laws and regulations o utside the U.S. ) active ingredient as such Reference Product ; ( b ) is marketed or sold in such country or jurisdic tion by a Third Party that ( i ) has not obtained the rights to marke t or sell such product as a Sublicensee or distribu tor of [COMPANY] or any of its Affiliates or Sublicensees, including pursuant to a license or settlement in connection with litigation with [COMPANY], its Affiliate or a Sublicensee under the Biologics Price Competition and Innovation Act of 2009 or an equivalent under foreign law and ( ii ) did not pu rchase such product in a chain of distribution that included [COMPANY] or any of its Affiliates or Sublicensees ; and ( c ) has obtained Regulatory Approval ( with all references in the definition Regulatory Approval to to be deemed references to such biopharmaceutical prod uct ) in such country or jurisdiction through reference to t he MAA and Regulatory Approval of the Reference Pro duct pursuant to an expedited or abbreviated approval pa thway established by the Regulatory Authorities in such country or jurisdiction pursuant to applicable Laws, including any such product that ( i ) with respect to such product in the U.S., has been approved or licensed as a bio similar or interchangeable product by FDA pursuant to Section 351(k ) of the Public Health Service Act ( 42 U.S.C. § 262(k ) ) or any subsequent or superseding law, sta tute or regulation, ( ii ) with respect to such product subje ct to the regulatory jurisdiction of the EMA, has b een approved as a similar biological medicine product by EMA as described in CHMP/437/04, issued 30 October 2005 or any subsequent or superseding law, statute or regulatio n, and ( iii ) with respect to such product outside t he U.S. and in a country which is not subject to the regulatory ju risdiction of the EMA, has obtained Regulatory Appr oval ( with all references in such definition to to b e deemed references to such biopharmaceutical produ ct ) by Regulatory Authorities in such other jurisdictions under analogous laws and regulations as those descr ibed the foregoing subsections ( i ) or ( ii )