Fundamental Circumstance definition
Fundamental Circumstance means the existence of material safety or efficacy concerns related to a Covered Product that does not constitute an Alternative Covered Product that would reasonably be expected to make the production and sale of such Covered Product, or receipt of applicable Regulatory Approvals for the treatment of transfusional iron overload in hemoglobinopathies, impracticable without substantially altering such Covered Product.
Examples of Fundamental Circumstance in a sentence
In the event that Parent believes that a Fundamental Circumstance has occurred, Parent shall promptly provide notice thereof to the Equityholders’ Representative together with reasonable detail (based upon the information then possessed by Parent) of the material facts known to Parent giving rise to such belief.