Definition of Post-Approval Clinical Study


Post-Approval Clinical Study means any clinical study in humans with respect to any Licensed Product that is within or in support of, or intended to expand, the Product Labeling for any Licensed Product.
Sample 1

Examples of Post-Approval Clinical Study in a sentence

For clarity, inclusion of any Non-Required Post-Approval Clinical Study in the Development Plan shall be subject to approval by the Joint Development Committee in accordance with Section 3.5(b).
Neither Party shall conduct, and each Party shall cause its Affiliates and sublicensees not to conduct, any Non-Required Post-Approval Clinical Study except in accordance with the Development Plan.
If either Party, or its Affiliates or sublicensees wishes to conduct a Non-Required Post-Approval Clinical Study, such Party shall propose such Non-Required Post-Approval Clinical Study to the Joint Development Committee for potential inclusion in the Development Plan.