Operational Authority of Sponsoring Party Generally Sample Clauses

Operational Authority of Sponsoring Party Generally. The Sponsoring Party, as designated in the Clinical Obligations Schedule of the Study Plan for each Combined Therapy Study, shall, subject to the oversight of the JDC as provided in Sections 2.3 and 2.4, the terms of the Protocol and the terms and conditions of this Agreement: (i) manage and be primarily responsible for conducting the Combined Therapy Study; (ii) be responsible for regulatory interactions with respect to the Combined Therapy Study; and (iii) be responsible for the following with respect to the Combined Therapy Study: (1) the selection and management of the Study Sites from the CRO/Study Site List (including budget negotiations with vendors, timelines and contingency planning), (2) conducting clinical study start-up activities (including engaging the CRO(s), communicating with and obtaining approval from institutional review boards (each an “IRB”) and/or ethics committees, as applicable, and drafting for JDC approval the template ICF and CRF for the Combined Therapy Study), (3) subject recruitment and retention activities, (4) ongoing site monitoring and quality assurance audits, (5) subject to the terms of the Pharmacovigilance Agreement, management of safety reporting by contract research organizations and clinical Study Sites, (6) ongoing medical monitoring, (7) management, monitoring and audits of contract research organizations (“CRO”) in connection with each CRO Agreement , and (8) inquiries from clinical study subjects ((1)-(8), collectively, the “Operational Matters”). The JDC shall set up a mechanism for the Other Party or a working team of the JDC to be informed and updated on a periodic basis regarding Operational Matters, so that if the Other Party has any concerns or disagreements regarding same, the matter can be escalated to the JDC for review. The Sponsoring Party shall provide the Other Party with access to the Study Data in accordance with the terms and conditions of this Agreement.
Sample 1
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Operational Authority of Sponsoring Party Generally. The Sponsoring Party, as designated in the Clinical Obligations Schedule of the Study Plan for each Combined Therapy Study, shall, subject to the terms of the Protocol, and the terms and conditions of this Agreement:
Sample 1

Related to Operational Authority of Sponsoring Party Generally

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  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

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