Definition of Positive Phase 3 Trial Results

  1. Positive Phase 3 Trial Results means a Phase 3 Trial that meets its primary end-point as defined in the study protocol for such Phase 3 Trial, and the safety profile supports continued clinical testing in the applicable Indication and/or filing of an application for Marketing Approval.

Definition of Positive Phase 3 Trial Results in License and Collaboration Agreement

Positive Phase 3 Trial Results means a Phase 3 Trial that meets its primary end-point as defined in the study protocol for such Phase 3 Trial, and the safety profile supports continued clinical testing in the applicable Indication and/or filing of an application for Marketing Approval.