Definition of Post-Approval Commitments

  1. Post-Approval Commitments means any human clinical study or other test or study, including a Phase 4 Trial that is required or other obligation, including an obligation to develop a risk evaluation and mitigation strategy or similar safety program, that is imposed with respect to an Initial Product by a Regulatory Authority as a condition of obtaining or maintaining NDA Approval for such Initial Product for an indication, to be performed following NDA Approval of such Licensed Product for such indication.

Definition of Post-Approval Commitments in License and Collaboration Agreement

Post-Approval Commitments means any human clinical study or other test or study, including a Phase 4 Trial that is required or other obligation, including an obligation to develop a risk evaluation and mitigation strategy or similar safety program, that is imposed with respect to an Initial Product by a Regulatory Authority as a condition of obtaining or maintaining NDA Approval for such Initial Product for an indication, to be performed following NDA Approval of such Licensed Product for such indication.