definiens: NBE'sNCE " ) or ( b ) a new, novel and innovator biological substance derived from a living organism or a DNA or RNA mechanism ( ), in each case, ( a ) and ( b ), ( i ) . in any therapeutic class and for all human and animal prophylactic and therapeutic uses in all formulations and dosage forms and for any and all indications, ( ii ) which have not been developed as of the Closing Date and which could not be commercialized in the United States without first filing a New Drug Application ( liNDABLA " ), as the case may be, and obtaining the approval of the FDA to such NDA or BLA, as the case may be, and ( iii ) which upon obtaining such approval of the FDA to such NDA or BLA, as the case may be, has been granted, or could reasonably be expected to be granted, at least 3 ( three ) years of data or market exclusivity from the appropriate Governmental Authority