REMS Sample Clauses

REMS. FDA has determined that a Risk Evaluation and Mitigation Strategy (“REMS”) is necessary to assure safe use of the Product. The Product is currently subject to the FDA-approved single shared system Vigabatrin REMS Program. EVL will have sole discretion over the evaluation and management of the Vigabatrin REMS Program. The REMS Payments will not include any historical setup fee for the REMS Program. The Parties shall each bear half of the incremental setup cost that either Party bears that are specific to the Product as a part of the Further Development Work.
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Related to REMS

  • PROCUREMENT CARD The State has entered into an agreement for purchasing card services. The Purchasing Card enables Authorized Users to make authorized purchases directly from a Contractor without processing Purchase Orders or Purchase Authorizations. Purchasing Cards are issued to selected employees authorized to purchase for the Authorized User and having direct contact with Contractors. Cardholders can make purchases directly from any Contractor that accepts the Purchasing Card. The Contractor shall not process a transaction for payment through the credit card clearinghouse until the purchased Products have been shipped or services performed. Unless the cardholder requests correction or replacement of a defective or faulty Product in accordance with other Contract requirements, the Contractor shall immediately credit a cardholder’s account for Products returned as defective or faulty.

  • Procurement All goods, works and services required for the Project and to be financed out of the proceeds of the Financing shall be procured in accordance with the provisions of Section III of Schedule 2 to the Financing Agreement.

  • Reconnection The Parties shall cooperate with each other to restore the Small Generating Facility, Interconnection Facilities, and the New York State Transmission System and Distribution System to their normal operating state as soon as reasonably practicable following a temporary disconnection.

  • Procurement Planning Prior to the issuance of any invitations to bid for contracts, the proposed procurement plan for the Project shall be furnished to the Association for its review and approval, in accordance with the provisions of paragraph 1 of Appendix 1 to the Guidelines. Procurement of all goods and works shall be undertaken in accordance with such procurement plan as shall have been approved by the Association, and with the provisions of said paragraph 1.

  • Contract Changes Changes may not be made in the terms and conditions of this contract without the agreement and written permission of the Director of Housing.

  • ADB’s Review of Procurement Decisions 11. All contracts procured under international competitive bidding procedures and contracts for consulting services shall be subject to prior review by ADB, unless otherwise agreed between the Borrower and ADB and set forth in the Procurement Plan. SCHEDULE 5 Execution of Project and Operation of Project Facilities; Financial Matters

  • Procurement Regulations The contract shall be governed by the applicable provisions of the Mississippi Personal Service Contract Review Board Rules and Regulations, a copy of which is available at 000 Xxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxxxx 00000 for inspection, or downloadable at xxxx://xxx.xxxx.xx.xxx.

  • Grooming The parties agree that the agency shall have the right to set reasonable and professional grooming standards for its employees. The agency and state agree to consult with the Association in the development of said grooming standards.

  • Problem Solving Employees and supervisors are encouraged to attempt to resolve on an informal basis, at the earliest opportunity, a problem that could lead to a grievance. If the matter is not resolved by informal discussion, or a problem-solving meeting does not occur, it may be settled in accordance with the grievance procedure. Unless mutually agreed between the Employer and the Union problem-solving discussions shall not extend the deadlines for filing a grievance. The Union Xxxxxxx or in their absence, the Local Union President, or Area Xxxxxxx, or Chief Xxxxxxx, either with the employee or alone, shall present to the appropriate supervisor a written request for a meeting. If the supervisor agrees to a problem- solving meeting, this meeting shall be held within fourteen (14) calendar days of receipt of the request. The supervisor, employee, Union Xxxxxxx, and up to one (1) other management person shall attempt to resolve the problem through direct and forthright communication. If another member of management is present that person will not be hearing the grievance at Step Two, should it progress to that Step. The employee, the Union Xxxxxxx or in their absence, the Local Union President, or Area Xxxxxxx, or Chief Xxxxxxx, may participate in problem-solving activities on paid time, in accordance with Article 31, Union Rights, Section 1H.

  • Processing Grievances The grievant shall be granted reasonable time off with pay from regularly scheduled duty hours to process a grievance, provided that the time off will be devoted to the prompt and efficient investigation and handling of grievances, subject to the following:

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