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.
Upon completion of the Transition Plan and subject to Article 4.6(a) with respect to Ongoing Clinical Studies and Post-Approval Marketing Studies to be sponsored by Licensor in accordance with Article 4.1(b), Licensee or its Affiliates (or if required by applicable Law, its Sublicensees) shall own all regulatory submissions, including all applications, for Marketing Approvals for the Product in the Field in the Licensee Territory.
For the avoidance of doubt, any Clinical Studies other than Post-Approval Marketing Studies and Phase IV Studies performed by Takeda shall be included in the Development Plan.
After Regulatory Approval, the Parties shall meet to discuss in good faith the cost of Product for Post-Approval Marketing Studies.
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.
With respect to any Ongoing Clinical Studies or Post-Approval Marketing Studies to be performed in accordance with Article 4.1(b), the Parties and their Affiliates shall cooperate fully so that the Party which is the sponsor of such Ongoing Clinical Study or Post-Approval Marketing Study, as applicable, in the Licensee Territory, may make the necessary and appropriate Regulatory Filings and submissions and undertaking such regulatory interactions.
Each Party also shall have the right to require that any of its Confidential Information (but not the results of the Clinical Studies or Post-Approval Marketing Studies for a Licensed Product in the Field in the applicable country in the Territory that have been approved for disclosure pursuant to the Publication Policies) that is disclosed in any such proposed publication or presentation be deleted prior to such publication or presentation.
For the avoidance of doubt, any Post-Approval Marketing Studies and Phase IV Studies shall be included in the Commercialization Plan.
At each meeting of the JSC, each Party will report on its Development activities of the Product in the Field that such Party and its Affiliates has performed or caused to be performed since the last meeting of the JSC, and evaluate the work performed with respect to any Ongoing Clinical Studies, and Post-Approval Marketing Studies, and provide such other information as may be reasonably requested by the JSC with respect to such Development activities.
Xxxxxx shall fund, conduct and direct any Post-Approval Marketing Studies determined by the JCC provided that such Post-Approval Marketing Studies shall not negatively impact: (a) Sucampo’s marketing of the Product outside of the Territory or (b) Sucampo’s marketing of the Product for Other Indications in the Territory.