JSC Oversight Sample Clauses

JSC Oversight. In addition to Section 3.2(a), (b) and (c) above with respect to Regulatory Filings and meetings with Regulatory Authorities, Shionogi’s Development and Commercialization activities, including the content and subject matter of, and strategy for, any MAA, all correspondence submitted to Regulatory Authorities related to clinical trial design, all proposed labeling and labeling discussions and decisions with Regulatory Authorities, and all post-Marketing Approval labeling discussions and decisions with Regulatory Authorities (including the final approved labeling), and post-Marketing Approval labeling changes or expansions, in each case relating in any way to Licensed Product, shall be subject to reasonable oversight by the JSC.
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JSC Oversight. All safety and pharmacovigilance matters arising out of the Arvinas Clinical Trial Activities shall be performed in a coordinated manner under the oversight of the JSC. The JSC shall facilitate timely information sharing, analysis, discussions and alignment with respect to all safety and pharmacovigilance issues arising out of the Arvinas Clinical Trial Activities. The Parties acknowledge that they shall strive for consensus on safety and pharmacovigilance matters within the purview of the JSC; provided, that Arvinas will have the right to promptly take any reasonable and appropriate actions necessary (e.g., safety-related decisions and submissions and interactions with health authorities relating to its sponsor responsibilities) to ensure the safety of study participants in the event that any serious safety issues requiring an Urgent Safety Measure arise in connection with the performance of the Arvinas Clinical Trial Activities; provided, however, that in such event Arvinas shall notify Novartis and the JSC as soon as possible (and in any event within [**]).
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Related to JSC Oversight

  • Oversight The Licensing Officer shall oversee the quality of the services provided by the Licensee and the reasonableness of the prices charged. The Licensing Officer may advise the Licensee from time to time of any source of dissatisfaction and request correction.

  • Board Oversight Within 60 days of this Agreement, the board of directors of the Bank shall submit to the Reserve Bank a written plan to strengthen board oversight of the management and operations of the Bank. The plan shall, at a minimum, address, consider, and include:

  • Oversights If failure to pay any premium due or to perform any other act required by this Agreement is unintentional and is caused by misunderstanding or oversight, the Reinsured and the Reinsurer will adjust the situation to what it would have been had the misunderstanding or oversight not occurred.

  • Supervision and Oversight The Contractor shall be solely responsible for providing supervision and oversight to all the Contractor’s personnel that are assigned to the Agency properties pursuant to this contract.

  • OVERSIGHT SERVICES Oversight services for the Fund provided by Price Associates shall include all oversight of BNY Mellon, Delegates and service providers that provide accounting, administrative, and tax support services and not specifically provided for under each Fund’s Investment Management Agreement. Price Associates provides all accounting, administrative, tax and oversight services to the Funds listed on Exhibit A2, including the below. Accounting Services provided by Price Associates shall include, among other things: · oversight of quality control, including processing results related to fund accounting services provided by Delegates or other third party service providers relating to pricing. Such oversight includes, but is not limited to, review of (a) NAV calculations and fund valuations, (b) securities pricing and resolution of pricing exceptions, and (c) calculation and preparation of any financial information or schedules; · end-of-day INAV oversight for ETFs that provide INAV · determining accounting and valuation policies, instructing Delegates and/or other service providers, and/or providing it with such advice that may be reasonably necessary, to properly account for all financial transactions and to maintain the Fund’s accounting procedures and records so as to ensure compliance with generally accepted accounting principles and tax practices and rules; and · calculating and authorizing expense accruals and payments; annual fund expense budgets; accrual analysis; rollforward calculations; payment of expenses; fees for payment to service providers; · facilitating on behalf of the Fund resolution and remediation of fund accounting issues escalated by Delegates and/or other service providers; · preparing daily NAV calculations, including all necessary component services such as valuation and particularly private company investment valuation, corporate actions processing, trade processing, and performing month-end and fiscal-period-end close processes; · recordkeeping as required; and · such other accounting services as agreed to by the parties not otherwise performed by Price Associates under the Investment Management Agreement. Administrative Services provided by Price Associates shall include, among other things: · ensuring maintenance for the Fund of all records that may be reasonably required in connection with the audit performed by the Fund’s independent registered public accountants, or by the Securities and Exchange Commission (“SEC”), the Internal Revenue Service (“IRS”) or such other Federal or state regulatory agencies; · cooperating with the Fund’s independent registered public accountants and taking all reasonable action in the performance of its obligations under the Agreement to assure that the necessary information is made available to such accountants for the expression of their opinion without any qualification as to the scope of their examination including, but not limited to, their opinion included in the Fund’s annual report on Form N-CSR and annual amendment to Form N-1A; · implementing and maintaining the systems, data storage and reporting necessary to perform services outlined herein; · all efforts concerning financial reporting services, including shareholder reports and financial information in regulatory filings; N-PORT and N-CEN; and other financial reporting services as necessary; · determining financial reporting policies, maintaining adequate controls over financial reporting to provide complete and accurate financial information and disclosures that are certified by officers of the Funds. Providing sub-certifications, as requested by officers of the Funds, for the adequacy of such controls and the completeness and accuracy of information included in Form N-CSR or any other form that may require certification; · periodic testing of Internal Revenue Code qualification requirements; · prepare and furnish fund performance information; · prepare and disseminate vendor survey information; · prepare and file Rule 24f-2 notices and payment; and · such other administrative services as agreed to by the parties, not otherwise performed by Price Associates under the Investment Management Agreement.

  • Joint Union/Management Committee It shall be appropriate for either the Union or the University to request that a Joint Union/Management committee be convened, with Environmental Health and Safety as a participating member, to discuss health and safety concerns and to explore options for addressing those concerns through appropriate training or other approaches.

  • Labour Management Committee (a) Where the parties mutually agree that there are matters of mutual concern and interest that would be beneficial if discussed at a Labour Management Committee Meeting during the term of this Agreement, the following shall apply. (b) An equal number of representatives of each party as mutually agreed shall meet at a time and place mutually satisfactory. A request for a meeting hereunder will be made in writing prior to the date proposed and accompanied by an agenda of matters proposed to be discussed, which shall not include matters that are properly the subject of grievance or negotiations for the amendment or renewal of this agreement. Any representative(s) attending such meetings during their regularly scheduled hours of work shall not lose regular earnings as a result of such attendance. (c) It is agreed that the topic of a rehabilitation program for drug and alcohol abuse is an appropriate topic for the Labour-Management Committee. It is also agreed that the topic of the utilization of full-time and part-time staff is an appropriate topic for the Labour-Management Committee. The committee shall have access to work schedules and job postings upon request. (d) It is understood that joint meetings with other Labour-Management Committees in the Hospital may be scheduled concerning issues of mutual interest if satisfactory to all concerned. (e) Where two or more agreements exist between a Hospital and CUPE the Committee may be a joint one representing employees under both agreements, unless otherwise agreed.

  • Development Committee Arcadia and Xxxxxx shall establish a development committee (the “Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and Xxxxxx. The Development Committee shall be chaired by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of Xxxx Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR as provided in Section 12(a).

  • JOINT LABOUR MANAGEMENT COMMITTEE A Joint Labour Management Committee shall be established to attend to those matters which are of mutual interest. To ensure its effectiveness the Committee shall be separate and apart from the grievance procedure.

  • Professional Development Committee There shall be a Professional Development Committee composed of two (2) members of the Association one of whom shall be the Bargaining Unit President or designate and two (2) representatives of the Hospital one of whom shall be the Chief Nursing Officer or designate and one human resources representative.

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