Definition of Post-Approval Marketing Studies


Post-Approval Marketing Studies means a human clinical trial or other test or study with respect to the Product for use in the Field in the Territory, which test or study is conducted on a voluntary basis by a Party (rather than under a mandate from a Regulatory Authority in the applicable country in the Territory in order to obtain or maintain Regulatory Approval for the Licensed Product in the Field in such country in the Territory) after the MAA for the Licensed Product in the Field in such country in the Territory has been approved by the Regulatory Authority in such country in the Territory. Any human clinical study that is intended to expand the label for the Licensed Product for use in the Field in such country in the Territory shall be a Clinical Study. Subject to the foregoing, Post-Approval Marketing Studies may include clinical studies conducted in support of pricing or reimbursement for the Licensed Product in the Field in such country in the Territory, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing studies, investigator sponsored studies, and health economic studies.
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Examples of Post-Approval Marketing Studies in a sentence

The Parties, through the JDC, shall develop policies and procedures (the "Publication Policies") for any publication with respect to the results of Clinical Studies and Post-Approval Marketing Studies for a Product in the Field in the Territory, including disclosure applicable to clinical trial registries, which policies and procedures shall be consistent with the Parties' respective policies and procedures for publication and disclosure of the results of human clinical trials consistently applied.
All abstracts, manuscripts and presentations (including information to be presented verbally) that disclose results of Clinical Studies or Post-Approval Marketing Studies for a Product shall be reviewed and approved by the JDC in accordance with the Publication Policies.
All abstracts, manuscripts and presentations (including information to be presented verbally) that disclose results of Clinical Studies or Post-Approval Marketing Studies for a Product in the Field in the Territory shall be reviewed and approved by the JDC in accordance with the Publication Policies.
After Regulatory Approval, the Parties shall meet to discuss in good faith the cost of Product for Post-Approval Marketing Studies.
Clinical Study(ies) means Phase I Study, Phase II Study, Phase III Study, Phase IV Study conducted anywhere in the world, or such other tests or studies in humans conducted anywhere in the world, that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for the Product in the Field in the Territory, but excluding Post-Approval Marketing Studies.