Post-Marketing Study definition

Post-Marketing Study means 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, that 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, but excluding any Supplemental Study.

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Post-Marketing Study means a product support clinical trial of a Licensed Product that is commenced after receipt of Regulatory Approval in the country where such trial is conducted. Post-Marketing Studies may include epidemiological studies, modeling and pharmacoeconomic studies, “post-marketing surveillance trials” and investigator-sponsored clinical trials studying a Licensed Product.

Post-Marketing Study means a product support clinical trial of a Licensed Product that is commenced after receipt of Regulatory Approval in the country where such trial is conducted. Post-Marketing Studies may include epidemiological studies, modeling and pharmacoeconomic studies, “post- marketing surveillance trials” and investigator-sponsored clinical trials studying a Licensed Product.

Examples of Post-Marketing Study in a sentence

• In relation to the Territory, Astellas shall [***] for any Post-Marketing Study and shall present it to the JDC [***].

• 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”).

• BSC’s Urology & Women’s Health Safety Team will perform medical safety functions for the Business’ Prolieve Post-Marketing Study (A Multi-Center, Post-Marketing Device Study to Assess the Long Term Safety and Efficacy of the Study Device in Patients with Benign Prostatic Hyperplasia (BPH)), including: • Complaint processing; • Independent Medical Reviewer management; and • Participate in Clinical Trial Safety Review meetings.

• 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).

• In relation to the countries outside Territory other than in the ▇▇▇▇ Territory, Optimer shall first prepare a protocol for any such Post-Marketing Study and present it to the JSC for comment.

• Genzyme shall be responsible for one hundred percent (100%) of the Development Costs incurred in accordance with a Development Plan in the conduct of (a) clinical trials specifically required to obtain Marketing Approval in the Genzyme Territory that are not required to obtain Marketing Approval in the Osiris Territory, and (b) any Commercial Post-Marketing Study of a Product for an Indication in the Genzyme Territory.

• If a Post-Marketing Study in the Takeda Territory is required by the applicable Regulatory Authority or the Parties agree that such a Post- Marketing Study is necessary or reasonably useful, Takeda shall be responsible for such Post- Marketing Study in the Takeda Territory.

• This Agreement and Schedule I hereto are the only agreement and understanding between the parties, and supersedes all prior and contemporaneous agreements, summaries of agreements, descriptions of compensation packages, discussions, negotiations, understandings, representations or warranties, whether verbal or written, between the parties pertaining to such subject matter.

• For clarity, if a Party desires to conduct a Post-Marketing Study that has not been approved by the Parties for inclusion under the applicable Development Plan under Section 4.2.5(e) above, such Party may perform such Post-Marketing Study, at its own expense.

• If the Regulatory Authority requires that a Post-Marketing Study for the Licensed Product be conducted in the Licensed Territory, or if the Parties mutually agree that a Post-Marketing Study for the Licensed Product in the Licensed Territory is necessary (such agreement not to be unreasonably withheld, conditioned, or delayed), Zai shall be responsible for conducting such Post-Marketing Study for the Licensed Product in the Licensed Territory, including [***].

More Definitions of Post-Marketing Study

Post-Marketing Study means any study conducted with respect to a Product after submission of an application for Regulatory Approval for such Product, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a drug’s risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of the disease, or studies of the use of the drug over a longer period of time. For clarity, Post-Marketing Studies shall not include studies designed to determine the efficacy of a drug for an Indication for which Regulatory Approval has not been granted or studies that are otherwise required to obtain or maintain Regulatory Approval.

Post-Marketing Study means any study conducted by or for Takeda in the Takeda Territory with respect to a Vaccine after submission of an application for Regulatory Approval for such Vaccine, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a Vaccine’s risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the Vaccine in other patient populations or other stages of the disease, or studies of the use of the Vaccine over a longer period of time, but, in any case, excluding any study that is necessary to be completed in order to obtain Regulatory Approval.

Post-Marketing Study means any study conducted by or for Zai in the Licensed Territory with respect to the Licensed Product after submission of a Regulatory Approval Application for the Licensed Product, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a drug’s risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of the disease, or studies of the use of the drug over a longer period of time, but, in any case, excluding any study that is necessary to be completed in order to obtain Regulatory Approval.

Post-Marketing Study has the meaning set forth in the Master Agreement.

Post-Marketing Study means any study conducted by or for Zai in the Licensed Territory with respect to the Licensed Product after submission of a Regulatory Approval Application for the Licensed Product, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a drug’s risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of the disease, or studies of the use of the drug over a longer period of time, but, in any case, excluding any study that is necessary to be completed in order to obtain Regulatory Approval.