Review and Oversight. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, the CDC IRB will provide:
Review and Oversight. The Relying Institution will also oversee the safe and appropriate conduct of the Expanded Access IND at its institution and will ensure compliance with applicable federal, state, local or institutional requirements related to the protection of human subjects, which may include investigating and managing any incidence, experience, or outcome that may rise to the level of an unanticipated problem and/or serious or continuing noncompliance. Should any such requirements conflict with the decisions or requirements of the CDC IRB, the Relying Institution must raise those conflicts for consideration by the CDC IRB. The Relying Institution will also provide all information about conduct of the Expanded Access IND at the Relying Institution that the CDC IRB requires to meet its review and reporting requirements. The Relying Institution will establish a mechanism that allows human subjects and others to report concerns about the conduct of the Expanded Access IND.
Review and Oversight. All responsibilities under this Article 7 shall be subject to the review and oversight of the Joint Project Team and the Joint Steering Committee as set forth in Article 5.
Review and Oversight. Other than with respect to Section 6.2.1, which shall be in the sole discretion of Sandoz, all responsibilities of the Parties with respect to Commercialization of the Product shall be subject to the oversight and review of the Joint Project Team and the Joint Steering Committee as set forth in Article 5. Notwithstanding Section 5.8 or any other provision of this Agreement, Sandoz and its Affiliates (or, with respect to Section 11.6.1, Momenta, its Affiliates and sublicensees) shall have the sole discretion and exclusive authority to set the prices for the Product sold to Third Parties. The Parties shall agree upon the trademark to be used for the Product, which shall not include any trademark or tradename or a part thereof that uses the name "Novartis" or "Sandoz" or a derivative thereof or any other trademark or part or derivative thereof that is the name or derivative of a name of any other Sandoz Affiliate.
Review and Oversight. The reviewing IRB shall conduct initial and continuing reviews, and shall review amendments to approve protocols and reports of unanticipated problems and serious and/or continuing noncompliance. The reviewing IRB shall have the authority to suspend or terminate the research. The reviewing HRPP shall notify the relying HRPP of any determinations of unanticipated problems, serious or continuing noncompliance, and suspensions and terminations.
Review and Oversight. 8. IWAC will regularly report on its activities to the Meeting of the Parties to the Convention, and, as relevant, to the Protocol’s Meeting of the Parties and to their working groups, and will be guided by the recommendations of these bodies in its further work.
Review and Oversight. Perform initial and continuing reviews of submitted Research; reviews of amendments; reviews of unanticipated problems that may involve risks to subjects or others; reviews of potential noncompliance with applicable federal animal research regulations or policies (including but not limited to PHS Policy, the Animal Welfare Act, the Guide for Care and Use), with the requirements or determinations of the Reviewing Institution and associated OLAW reporting, as relevant; and reviews of other documents, requests, or information related to the approval and continuing oversight of the Research, as applicable. The review and oversight of the Research by the Reviewing Institution will be performed in accordance with applicable federal animal research regulations and policies.
Review and Oversight. Applications for catastrophic illness leave will be reviewed by a task force comprised of three (3) classified employees appointed by the CFCE and the Manager of Benefits and the Vice Chancellor of Human Resources or his/her designee. • The task force will recommend approval or denial of catastrophic leave to an employee. • To safeguard privacy, neither the name of the individual requesting the time nor the diagnosis will be shared with the full committee. Rather the Manager of Benefits will receive the applications and doctor’s verification and will present the relevant facts to the full committee for review and approval/denial.
Review and Oversight. The TOC will designate a panel for review, oversight and interpretation of the research and monitoring program. The purpose of this panel is to:
Review and Oversight. The Reviewing IRB shall conduct initial and continuing reviews, and shall review amendments to approved protocols and reportable events, all in accordance with applicable state and federal laws, regulations, guidance, and rulings related to the protection of human subjects. The Reviewing IRB shall have the authority to suspend or terminate IRB approval of research subject to this MOU, and shall notify the Relying IRB in writing of all determinations resulting from review of unanticipated problems, serious or continuing noncompliance, and other noncompliance with approved protocols. In the event that the Reviewing IRB receives an inquiry from any governmental official related to research for which the Reviewing IRB is acting as IRB of Record for the Relying Institution, the Reviewing IRB shall inform the Relying IRB immediately, and shall provide any new information to the Relying IRB during the course of such an inquiry.
