definiens: means, with respect to a Licensed Product in a co untry or jurisdiction specified below, any product sold by a Third Party that ( a)(i ) in the United States, is subject to a l icense by the FDA under Section 351(k ) of the PHSA as a product t hat is ( as defined in Section 351(i)(2 ) of the PHSA ) to, or ( as defined in Secti on 351(i)(3 ) of the PHSA ) with, such Licensed Produ ct, ( ii ) in the EU, has been licensed as a similar biol ogical medicinal product by the EMA pursuant to Dir ective 2001/83 / EC, as may be amended, or any subsequent or superseding law, statute or regulation, or ( iii ) i n any country outside the United States and the EU, has r eceived Regulatory Approval in an abbreviated licen sure procedure as a biogeneric, biosimilar or interchang eable product from the applicable Regulatory Author ity in such country or jurisdiction, in reliance upon the prior Regulatory Approval ( or data therein ) of such Licensed Product ; and ( b ) is not an Authorized Biosimilar Ve rsion of such Licensed Product ; where means any product that ( 1 ) is sold under the BLA filed by [COMPANY] or its Affiliate or Sublicensee for such Licensed Product, and ( 2 ) is n ot sold under the product trademark under which suc h Licensed Product is sold by [COMPANY], its Affiliate o r Sublicensee, as applicable