Definition of Post-Approval Clinical Trial

  1. Post-Approval Clinical Trial means (i) any Clinical Trial conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval and (ii) any Clinical Trial conducted after the first Regulatory Approval in the same indication for which the Licensed Product received Regulatory Approval in the Territory.

Definition of Post-Approval Clinical Trial in License and Collaboration Agreement

Post-Approval Clinical Trial means (i) any Clinical Trial conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval and (ii) any Clinical Trial conducted after the first Regulatory Approval in the same indication for which the Licensed Product received Regulatory Approval in the Territory.


Definition of Post-Approval Clinical Trial in Collaboration License and Option Agreement

Post-Approval Clinical Trial means (i) any Clinical Trial conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval and (ii) any Clinical Trial conducted after the first Regulatory Approval in the same disease state for which the Licensed Compound or Licensed Product received Regulatory Approval in the Territory.