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. In accordance with 21 CFR parts 50, 56, and 312 and any other applicable requirements, CDC IRB will provide:
a. initial and continuing review of materials related to the Expanded Access IND;
b. review of amendments to materials related to the Expanded Access IND;
c. review of local context considerations as provided by the Relying Institution;
d. review of potential unanticipated problems involving risk to subjects or others as reported to the CDC IRB;
e. review of serious or continuing noncompliance as reported to the CDC IRB; and
f. oversight of the conduct of the Expanded Access IND to include the informed consent process.
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 approved 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 HRPP of the reviewing IRB shall notify relying HRPPs of any determinations of unanticipated problems, serious or continuing noncompliance, and suspensions and terminations.
Review and Oversight. (1) At least once every 72 hours, the security dorm supervisor or designee must speak with each youth admitted to the security unit on a self-referral.
(2) If a youth has not requested or agreed to a release within 72 hours after admission to the security unit on self-referral, the security dorm supervisor must consult with the facility administrator or designee to discuss reintegration strategies, service delivery and counseling activities, youth behavior, and possible dorm or facility transfer. This consultation is required every 24 hours thereafter.
(3) If a youth has not requested or agreed to a release within five calendar days after admission to the security unit on self-referral, the facility administrator must consult with the division director over residential services or designee to discuss reintegration strategies, service delivery and counseling activities, youth behavior, and possible dorm or facility transfer. This consultation is required at least once every 72 hours thereafter until the youth is released from the security unit.
(4) The youth’s multi-disciplinary team must monitor each youth’s pattern of self-referrals to the security unit for indications of ongoing or unresolved issues. The multi-disciplinary team must address these issues through case plan objectives, clinical referrals, reports to facility management, or other appropriate interventions.
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. All responsibilities under this Article 7 shall be subject to the review and oversight of the Committees as set forth in Article 5.
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. Other than with respect to Section 6.2, which activities shall be in the sole discretion of Sandoz, but subject to Section 5.2, all responsibilities of the Parties with respect to Commercialization of the Products shall be subject to the oversight and review of the JSC as set forth in Article 5. Notwithstanding Sections 1.89, 13.2, or any other provision of this Agreement (other than Section 5.2), Sandoz or its sublicensees shall have the right to set all of the prices for the sale of Products to Third Parties which are their immediate customers in the relevant Territories; provided, that, with respect to the Collaboration Products, such prices are generally consistent with the pricing strategy set therefor by the JSC, although the Parties recognize that Sandoz shall have the flexibility to change such prices in order to respond to specific market conditions, and, with respect to the Glycoprotein Products, the JSC shall discuss pricing strategy for such prices. Sandoz or its sublicensees shall be responsible for the distribution and sale of the Products and for invoicing and booking sales of the Products in the relevant Territories. The name of each Collaboration Product shall be the generic name of the compound it contains unless the Parties mutually agree that its name shall include a trademark or tradename or be protected as a trademark (a “Branded Collaboration Product”). For each Branded Collaboration Product, Sandoz may name such Product; provided, that such name shall not include any trademark or tradename or a part thereof that uses the name “Momenta”, “Sandoz” or a derivative of the foregoing or any other trademark or part or derivative thereof that is the name or derivative of a name of any Momenta Affiliate or Sandoz Affiliate, without the prior approval of Momenta. Once Sandoz, its Affiliate or sublicensee begins selling a particular Product in a particular country in the relevant Territory, Sandoz shall use Commercially Reasonable efforts to sell such Product in such country in such Territory, itself or through its Affiliates or sublicensees, unless Sandoz makes a Commercially Reasonable decision to cease selling such Product in such country.
