Definition of Post-Marketing Study


Post-Marketing Study means a non-human or human clinical study of a Collaboration Product initiated after receipt of Regulatory Approval for such Collaboration Product in a country or territory, that is required by the Regulatory Authority in such country or territory to maintain the Regulatory Approval for such Collaboration Product in such country or territory, but excluding any Secondary Indication Study.
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Examples of Post-Marketing Study in a sentence

For any such Joint Post-Marketing Study described in clause (a), the Parties will collaborate on the drafting of a detailed plan and budget for such Post-Marketing Study, which sets forth the responsibilities of each Party with respect to such study (Study Plan).
Upon the Parties mutual agreement on the Study Plan, the Development Plan shall be amended to add such Study Plan, and the study described therein will be designated as a Joint Post-Marketing Study, the costs of which will be shared in accordance with Section 3.7(b).
The term "Post-Marketing Study" shall mean a non-human or human clinical study of a Licensed Product initiated after receipt of Regulatory Approval for such Licensed Product in a country or territory, which is required by the Regulatory Authority in such country or territory to maintain the Regulatory Approval for such Licensed Product in such country or territory.
The term "Clinical Study" shall mean any Phase I Study, Phase II Study, Phase III Study, Pivotal Study, Post-Marketing Study, Supplemental Study or other study in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product, as applicable.
In relation to the Territory, Astellas shall [***] for any Post-Marketing Study and shall present it to the JDC [***].