Key Trials definition

Key Trials means either (a) the 301 Study and the 302 Study or, (b) [***] of the studies in (a) fails to meet its primary endpoints as determined in accordance with the statistical plan agreed upon by MAP and the FDA with respect to such failed study, then the study in (a) that met its primary endpoints, along with [***] that is conducted pursuant to the Initial Development Plan, as may be amended for such additional Phase III Clinical Trial, after the Effective Date.
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Examples of Key Trials in a sentence

  • If AstraZeneca believes that the Lead Licensed Product has failed to meet the Target Product Characteristics in the Key Trials conducted pursuant to the Initial Development Plan, as may be amended for any additional Phase III Clinical Trial, then AstraZeneca shall notify MAP in writing of such conclusions prior to the filing of the Drug Approval Application for the Lead Licensed Product in the United States.

Related to Key Trials

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.