Orphan Drug
Orphan Drug. Shall mean a Product that is protected (a) by "Orphan Drug" status under the U.S. Orphan Drug Act, (b) by a Supplementary Protection Certificate, as such term is defined in Council Regulation (EU) No. 1768/92, or (c) by a similar status granted under similar statutory provisions of another jurisdiction granting exclusive marketing rights in such jurisdiction.
Orphan Drug. Shall mean any drug designated by the U.S. Food and Drug Administration as an approved orphan drug under the Orphan Drug Act (Pub. L. 97-414). 1.7.
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