definiens: means, with respect to a Licensed Product in a country, a biological product that is sold in such country by a Third Party that ( a ) has been licensed as a biosimilar or interchangeable biological product by the FDA pursuant to section 351(k ) of the PHSA, or any subsequent or superseding law, statute, or regulation, and for which a Licensed Product is the reference product, as defined by s ection 351(i)(4 ) of the PHSA, ( b ) incorporates, cites, cross -references, or relies upon in any way any data or information contained in any Regulatory Submission for a Licensed Compound or Licensed Product in order to obtain or maintain any Regulatory Appr oval or Reimbursement Approval for such product, ( c ) has been granted a marketing authorization as a similar biological medicinal product by the European Union pursuant to Directive 2001/83 / EC and Parliament and Council Regulation No . ( EC ) 726/2004, each a s may be amended, or any subsequent or superseding law, statute or regulation, and for which a Licensed Product is the reference medicinal product as defined by Article 10(2)(A ) of Directive 2001/83 / EC, or ( d ) has achieved analogous regulatory marketing ap proval from a Regulatory Authority in another jurisdiction in reliance on the fact of, or the data supporting, the prior approval of such Licensed Product by such Regulatory Authority