REMS Program definition

REMS Program means the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.
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REMS Program means the Company’s Risk Evaluation and Mitigation Strategies program for the Product Ravicti.
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REMS Program means the XYREM REMS Program, as approved by the FDA, and as described in the XYREM REMS Documents.
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Examples of REMS Program in a sentence

  • ESSDS is strictly prohibited from selling, utilizing, or transferring REMS Program Items to any third-party under any circumstances not contemplated by this Agreement.

  • REMS Program Items shall be marked as property of Jazz Pharmaceuticals.

  • ESSDS shall not utilize or distribute REMS Program Items for any purpose other than as set forth in this Agreement and the Work Orders hereunder.

  • ESSDS shall furnish and maintain a suitable place for storage of REMS Program Items.

  • From the Effective Date of this Agreement, Jazz Pharmaceuticals shall provide REMS Program Items to ESSDS of the type and quantities to be reasonably determined by Jazz Pharmaceuticals for performance of REMS Pharmacy Services.

  • Legal title to all REMS Program Items shall remain with Jazz Pharmaceuticals.

  • US Bio shall provide certain support services relating to (i) the sale and use of the Product in the Field in the Territory and (ii) the REMS Program (collectively, the “Hub Services”).

  • Furthermore, in the event that Jazz Pharmaceuticals chooses to engage another pharmacy for commercial, non-clinical trial Product in addition to ESSDS, ESSDS shall maintain the right to continue to provide Services to any Patients enrolled in the REMS Program as of the date that ESSDS no longer maintains its exclusive pharmacy status.

  • Without limiting the scope of the foregoing, US Bio agrees that any promotional, educational or other materials delivered to Specialty Pharmacy Customers and/or Patients in connection with this Agreement shall be preceded or accompanied by the medication guide, the healthcare provider letter and/or any other materials required by the REMS Program, as applicable, and in accordance with the provisions of the REMS Program.

  • US Bio shall distribute Product, perform the Hub Services, and otherwise conduct all activities under this Agreement in accordance with the REMS Program and any additional policies Dyax implements and provides in writing to US Bio.


More Definitions of REMS Program

REMS Program means the XYREM REMS Program, as approved by the FDA, or any successor entity thereto as approved by FDA, including successor entities including additional oxybate formulations, and as described in the REMS Documents.
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REMS Program means a Risk Evaluation and Mitigation Strategy Program according to the FDA Amendments Act of 2007 (FDAAA).
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REMS Program means the single shared REMS program developed under this agreement to meet the requirements of section 505-1 of the FD&C Act for [DRUG NAME] Drug(s) and submitted for approval or approved by the FDA.
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REMS Program means the Company’s Risk Evaluation and Mitigation Strategies program for the Product Ravicti. “Services” has the meaning set forth in Section 5(b).
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REMS Program means the Risk Evaluation and Mitigation Strategy required to be implemented under Section 505-1 of the FFDCA in connection with the Regulatory Approval of the Product by the FDA.
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Related to REMS Program

  • PEBB program means the program within the HCA that administers insurance and other benefits for eligible employees (as described in WAC 182-12-114), eligible retired employees (as described in WAC 182-12-171 and 182-12-180), eligible survivors (as described in WAC 182-12-180, 182-12-250, and 182-12-265), eligible dependents (as de- scribed in WAC 182-12-250 and 182-12-260) and others as defined in RCW 41.05.011.

  • AML Program has the meaning ascribed thereto in Schedule 2.1(F)(8) hereof.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.