definiens: means, with respect to any Customer Product that is being sold in a country or regulatory jurisdiction ( the ), any biopharmaceutical product sold by a third party ( other than a third party acting on behalf of or in concert with Customer, any ofits aﬃliates, any Licensee, or any sublicensee or assignee of any of the foregoing ) in such country or jurisdiction, that through reference tothe Regulatory Approval of the Reference Product, is eligible for and has achieved regulatory approval in such country or jurisdiction pursuantto an abbreviated follow - on biological approval pathway established by the Regulatory Authority in such country or jurisdiction pursuant to theApplicable Laws, or otherwise is approved for marketing and sale in such country or jurisdiction by an abridged procedure in reliance, inwhole or in part, on the prior Regulatory Approval of the Reference Product or on the safety and eﬃcacy data included in the prior RegulatoryApproval ( in such country or jurisdiction ) of the Reference Product, including any such biopharmaceutical product that ( i ) with respect to suchbiopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42U.S.C. § 262 of the Public Health Service Act, or ( ii ) with respect to such biopharmaceutical product in any country or regulatory jurisdiction, has otherwise obtained Regulatory Approval from a Regulatory Authority pursuant to similar statutory or regulatory requirement as thatdescribed in the foregoing clause ( i ) in such other country or jurisdiction