definiens: means, with respect to a P roduct in a given country, any generic or biosimila r product sold by a Third Party not licensed or other wise authorized by or on behalf of [COMPANY] or a ny of its Affiliates or Sublicensees ( a ) that is a ( as defined in Section 351(i)(1 ) of the PHSA ) that is subject to a license for administration to humans u nder Section 351(a ) or 351(k ) of the PHSA and ( i ) c ontains an active ingredient that is the same as the active in gredient of such Product ( including any mRNA Constr ucts therein ) or ( ii ) is ( as defined in Sec tion 351(i)(2 ) of the PHSA ) or ( a s defined in Section 351(i)(3 ) of the PHSA ) to the Product ; or ( b ) that has received analogous Regulatory Approval from the applicable Regulatory Authority by referencing Regu latory Filings ( and data therein ) of such Product