definiens: means, with respect to a Product that is being sold in a country or regulatory jurisdiction in the Territory ( the ), a biopharmaceutical product sold by a Third Party ( other than a Third Party acting on behalf of or in concert with Pfizeror any [COMPANY] Affiliate or Sublicensee ) in such country or regulatory jurisdiction in the Territory that through reference to the RegulatoryApproval of the Reference Product, is eligible for and has achieved Regulatory Approval in such country or regulatory jurisdiction pursuant toan abbreviated follow - on biological approval pathway established by the Regulatory Authority in such country or regulatory jurisdictionpursuant to the applicable Law, or otherwise is approved for marketing and sale in such country or regulatory jurisdiction by an abridgedprocedure in reliance, in whole or in part, on the prior Regulatory Approval of the Reference Product or on the safety and efficacy datagenerated for the prior Regulatory Approval ( in such country or regulatory jurisdiction ) of the Reference Product, including any suchbiopharmaceutical product that ( i ) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar orinterchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, ( ii ) with respect to such biopharmaceuticalproduct subject to the regulatory jurisdiction of the EMA, has been approved as a similar biological medicine product by EMA as described inCHMP/437/04, issued 30 October 2005, as may be amended, or any subsequent or superseding law, statute or regulation or ( iii ) with respectto such biopharmaceutical product outside the United States and in a country which is not subject to the regulatory jurisdiction of the EMA, has otherwise obtained Regulatory Approval from a Regulatory Authority pursuant to similar statutory or regulatory requirement as thatdescribed in the foregoing subsections ( i ) and ( ii ) in such other country or regulatory jurisdiction in the Territory