definiens: means an indication for which the FDA has granted orphan status as defined in 21 C.F.R. Pt . 316, as may be amended from time to t ime . As of the Execution Date, such term is defined in 21 C.F.R. Pt . 316 as a rare disease or condition withi n the Permitted Indications which : ( a ) affects less than 200,000 persons in the U.S. or ( b ) affects more than 200,00 0 persons in the U.S. but for which there is no rea sonable expectation that the cost of developing and making available in the U.S. a drug for such disease or co ndition will be recovered from sales in the United States of suc h drug, as further defined in and for which Orphan Drug designation may be sought under the Orphan Drug Act of 1983