definiens: shall mean any formulation containing as an active constituent ( i ) a humanizedimmunoglobulin having complementarity determining regions, as disclosed in U.S. Patent No . 5,840,299 ( or anyfunctionally equivalent modification thereof ), and heavy and light chain variable frameworks from predominantly humanacceptor immunoglobulin ; ( ii ) an antigen - binding fragment of such humanized immunoglobulin having at least ten(10 ) amino acids ; or ( iii ) any such immunoglobulin or fragment as described in ( i ) and ( ii ) or any other fragmentcomprising the complementarity determining region of such humanized immunoglobulin, fused to another polypeptidefragment or another monomeric or polymeric compound, in each case under clauses ( i ), ( ii ), and ( iii ), which specificallybinds to an Alpha-4 Integrin and which has a molecular weight greater than 2,000 Daltons . The term Licensed Productshall, as applicable, include TYSABRI