Registration or Pivotal Study definition
Registration or Pivotal Study means a Phase III Clinical Study, a combined Phase II Clinical Study/Phase III Clinical Study, or any Phase II Clinical Study in lieu of a Phase III Clinical Study, or any well-controlled study intended to provide the substantial evidence of efficacy necessary and sufficient to support an NDA filing. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.