Orphan Drug Status

Orphan Drug Status. Means, with respect to a Licensed Product, that (i) the Secretary of the FDA has (1) approved an application filed pursuant to section 505(b) of the Federal Food, Drug and Cosmetic Act ("FD&C Act"), (2) issued a certification under section 507 of the FD&C Act, or (3) issued a license under section 351 of the Public Health Service Act for such Licensed Product designated under section 526 of the FD&C Act for a rare disease or condition, and (ii) the Licensed Product has obtained market... exclusivity under section 505A of the Food and Drug Administration Modernization Act of 1997. View More