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 (consistent with Section 2.1(c)) and management of the Study Sites (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 (each, a “CRO”) and clinical Study Sites, (6) ongoing medical monitoring, (7) management, monitoring and audits of CROs 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 (including via JDC meetings) 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 Section 5.1(a)(xv) and other applicable terms and conditions of this Agreement.
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Related to Operational Authority of Sponsoring Party Generally

  • Authority of General Partner The General Partner shall have sole authority to manage the business and affairs of the Partnership, which authority shall be delegated as provided in this Agreement. Subject to the limitations in this Agreement, the General Partner shall have the authority to take any action it deems to be necessary or appropriate in connection with the business and affairs of the Partnership, including without limitation the power and authority to: 8.1.1 acquire by purchase, lease, or otherwise, any real or personal property, tangible or intangible and to deal with, purchase, sell, mortgage, transfer, assign or otherwise dispose of any and all of the assets of the Partnership; 8.1.2 construct, operate, maintain, finance, and improve, and to own, sell, convey, assign, mortgage, or lease any real estate and any personal property; 8.1.3 sell, dispose, trade, or exchange Partnership assets in the ordinary course of the Partnership’s business; 8.1.4 enter into agreements and contracts and to give receipts, releases, and discharges; 8.1.5 purchase liability and other insurance to protect the Partnership’s properties and business; 8.1.6 execute or modify leases with respect to any part or all of the assets of the Partnership; 8.1.7 prepay, in whole or in part, refinance, amend, mod­ify, or extend any mortgages, trust deeds or security agreements which may affect any asset of the Partnership and in connection therewith to exe­cute for and on behalf of the Partnership any extensions, renewals, or modifications of such mortgages, trust deeds or security agreements; 8.1.8 execute any and all other instruments and docu­ments which may be necessary or in the opinion of the General Partner desirable to carry out the intent and purpose of this Agreement, including, but not limited to, documents whose operation and effect extend beyond the term of the Partnership; 8.1.9 make any and all expenditures which the General Partner, in its sole discretion, or in the discretion of the parties to whom the General Partner has delegated the authority to act for the Partnership as provided for above, deems necessary or appropriate in connection with the management of the affairs of the Partnership and the carrying out of its obligations and responsibilities under this Agreement, including, without limitation, all legal, accounting and other related expenses incurred in connection with the organization and financing and operation of the Partnership; 8.1.10 enter into any kind of activity necessary to, in con­nection with, or incidental to, the accomplishment of the purposes of the Partnership; 8.1.11 invest and reinvest Partnership reserves in short-term instruments or money market funds; 8.1.12 take any and all other action which is permitted under law or which is customary or reasonably related to the operation, management or conducting of the business or affairs of the Partnership, subject to the limitations expressly stated in this Agreement; and the enumeration of powers in this Agreement shall not limit the general or implied powers of the General Partner or any additional powers provided by law; 8.1.13 take any and all action required to guarantee the indebtedness of Xxxxxxx Xxxx, Inc and/or its subsidiaries; and 8.1.14 delegate any or all of its authority and powers as manager of the Partnership to the Management Committee.

  • Statewide HUB Program Statewide Procurement Division Note: In order for State agencies and institutions of higher education (universities) to be credited for utilizing this business as a HUB, they must award payment under the Certificate/VID Number identified above. Agencies, universities and prime contractors are encouraged to verify the company’s HUB certification prior to issuing a notice of award by accessing the Internet (xxxxx://xxxxx.xxx.xxxxx.xx.xx/tpasscmblsearch/index.jsp) or by contacting

  • E1 Authority Data E1.1 The Contractor shall not delete or remove any proprietary notices contained within or relating to the Authority Data.

  • Required Consents; Authority All consents, approvals, authorizations and orders necessary for the execution and delivery by such Selling Stockholder of this Agreement and the Power of Attorney (the “Power of Attorney”) and the Custody Agreement (the “Custody Agreement”) hereinafter referred to, and for the sale and delivery of the Shares to be sold by such Selling Stockholder hereunder, have been obtained; and such Selling Stockholder has full right, power and authority to enter into this Agreement, the Power of Attorney and the Custody Agreement and to sell, assign, transfer and deliver the Shares to be sold by such Selling Stockholder hereunder; this Agreement, the Power of Attorney and the Custody Agreement have each been duly authorized, executed and delivered by such Selling Stockholder.

  • 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.

  • EMPLOYER AUTHORITY 5.1 The Employer retains the full and unrestricted right to operate and manage all human resources, facilities, and equipment; to establish functions and programs; to set and amend budgets; to determine the utilization of technology; to establish and modify the organizational structure; to select, direct and determine the number of personnel; to establish work schedules; and to perform any inherent managerial function not specifically limited by this agreement. 5.2 Any term and condition of employment not specifically established or modified by this agreement shall remain solely within the discretion of the Employer to modify, establish, or eliminate.

  • Developer Authority Consistent with Good Utility Practice and this Agreement, the Developer may take whatever actions or inactions with regard to the Large Generating Facility or the Developer Attachment Facilities during an Emergency State in order to (i) preserve public health and safety, (ii) preserve the reliability of the Large Generating Facility or the Developer Attachment Facilities, (iii) limit or prevent damage, and (iv) expedite restoration of service. Developer shall use Reasonable Efforts to minimize the effect of such actions or inactions on the New York State Transmission System and the Connecting Transmission Owner’s Attachment Facilities. NYISO and Connecting Transmission Owner shall use Reasonable Efforts to assist Developer in such actions.

  • Authority Data The Contractor shall use the Authority Data only as necessary for the performance of its obligations under this Contract unless otherwise authorised in writing by the Authority.

  • Territorial application This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.

  • Grievance Commissioner System This is to confirm the discussion of the parties during collective bargaining that they are committed to encouraging early discussion and resolution of labour relations issues at the local level and seek to resolve grievances in a timely and cost efficient manner. To that end, this is to confirm that pursuant to Article 8, the parties agree that the Employer and Union at individual nursing homes may agree to utilize the following process in order to resolve a particular grievance through the utilization of a joint mediation-arbitration procedure:

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