Post-Approval Clinical Trial means any clinical trial conducted in an Indication after the Regulatory Approval of such Indication.
Post-Approval Clinical Trial means (a) any Clinical Trial conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval and (b) 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.
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.
More Definitions of Post-Approval Clinical Trial
Post-Approval Clinical Trial means any Clinical Trial for use of a [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Collaboration Product in an indication, other than a Phase III Clinical Trial or Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication.
Post-Approval Clinical Trial has the meaning set forth in the Financial Exhibit.
Post-Approval Clinical Trial means any clinical trial for use of a Product in an indication, other than a Phase III or Phase IV clinical trial, to be conducted after a Regulatory Approval which approves selling and/or marketing such Product for such indication.
Post-Approval Clinical Trial means any Clinical Trial for use of a Collaboration Product in an indication, other than a Phase III Clinical Trial or Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication. Post-Approval Clinical Trial shall also include investigator- sponsored studies in approved indications and indications for which regulatory approval has not yet been granted. To the extent there is a pre-clinical component of a Post-Approval Clinical Trial, the pre-clinical work will be considered part of the Post-Approval Clinical Trial.
Post-Approval Clinical Trial means any Clinical Trial for use of a
Post-Approval Clinical Trial means any Clinical Study in an indication for an Eisai Collaboration Product, other than a Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication.
Post-Approval Clinical Trial means a clinical trial of a Product that is completed after receipt of Regulatory Approval of such Product and that is not required by the applicable Regulatory Authority as a condition to receiving such Regulatory Approval. A Post-Approval Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Momenta Pharmaceuticals, Inc. studies, and investigator-sponsored clinical trials studying Product that are approved by the JSC and that otherwise fit the foregoing definition.