definiens: means a marketing exclusivity right conferred as a result of ( a ) a designation as a drug for rare diseases or conditions under Sections 525 et seq . of 5 NYH7J29982 CONFIDENTIAL T"EATMENT REQUESTED PURSUANT TO 5 USC § 552 AND 17 C.F.R .. § § 240.12(b)(4 ) AND 200.83 BY LETTER FROM MILBANK . TWEED . HADLEY & McCLOY LLP DATED MARCH 12.2004 CONFIDENTIAL TREATMENT REQUESTED the FDC Act or EU Regulation No . 14112000, or ( b ) the completion of pediatric studies requested by the FDA under Section SOSA(a ) of the FOC Act and, in each of the foregoing, the equivalent rights in any other country which confer marketing exclusivity rights