Definition of Pre-Approval Clinical Trial

  1. Pre-Approval Clinical Trial means a controlled clinical trial of a Licensed Product in humans that (a) is prospectively designed to demonstrate statistically whether such Licensed Product is effective and safe for use in a particular disease or condition in a manner sufficient to file an application for Marketing Authorization for such Licensed Product, and (b)

Definition of Pre-Approval Clinical Trial in License Agreement

Pre-Approval Clinical Trial means a controlled clinical trial of a Licensed Product in humans that (a) is prospectively designed to demonstrate statistically whether such Licensed Product is effective and safe for use in a particular disease or condition in a manner sufficient to file an application for Marketing Authorization for such Licensed Product, and (b)