definiens: means, with respect to a Product that is being sold in a country or regulatory jurisdiction worldwide ( the ), a biopharmaceutical product sold by a Third Party ( other than a Third Party acting on behalf of or in concert with Purchaser or Dynavax or any Affiliate or sublicensee or assignee of Dynavax or Purchaser ) in such country or regulatory jurisdiction worldwide that through reference to the regulatory approval of the Reference Product, is eligible for and has achieved regulatory approval in such country or regulatory jurisdiction pursuant to an abbreviated foll ow - on biological approval pathway established by the regulatory authority in such country or regulatory jurisdiction pursuant to the applicable law, or otherwise is approved for marketing and sale in such country or regulatory jurisdiction by an abridged p rocedure in reliance, in whole or in part, on the prior regulatory approval of the Reference Product or on the safety and efficacy data generated for the prior regulatory approval ( in such country or regulatory jurisdiction ) of the Reference Product, inclu ding any such biopharmaceutical product that ( i ) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, ( ii ) with respect to such biopharmaceutical product subject to the regulatory jurisdiction of the EMA, has been approved as a similar biological medicine product by EMA as described in CHMP/437/04, issued 30 October 2005, as may be amended, or any subsequent o r superseding law, statute or regulation or ( iii ) with respect to 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 that described in the foregoing subsections ( i ) and ( ii ) in such other country or regulatory jurisdiction