definiens: means, with respect to a Licensed Product in [ * * * ], any generic, biosimilar or interchangeable product sold by a Third Party that ( a ) has been licensed ( i ) as a biosimilar ( as defined inSection 351(i)(2 ) of the PHSA ) or interchangeable ( as defined in Section 351(i)(3 ) of the PHSA ) biological product bythe FDA pursuant to Section 351(a ) or 351(k ) of the PHSA or ( ii ) a generic product under Section 505(b)(2 ) or 505(j ) ofthe FD&C Act or any subsequent or superseding law, statute or regulation, ( b ) has been licensed as a similarbiological medicinal product by EMA pursuant to Directive 2001/83 / EC, as may be amended, or any subsequent orsuperseding law, statute or regulation or ( c ) has otherwise received Regulatory Approval as a generic, biosimilar orinterchangeable product from another applicable Regulatory Authority in such country, where in the case of each ofclauses ( a ), ( b ) or ( c ) above, such Licensed Product is the reference product for purposes of determining biosimilarityor interchangeability of the Third Party product