Xyrem Success Program definition

Xyrem Success Program means the program for patients taking Xyrem for which CuraScript and ESSDS shall perform the Covered Services hereunder, and which, as between the parties, is Jazz Pharmaceuticals’ property and proprietary information. The Xyrem Success Program was created for the purpose of complying with FDA-mandated requirements relating to Product.
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Examples of Xyrem Success Program in a sentence

  • Jazz Pharmaceuticals may, without restriction, use any language referring to the Xyrem Success Program, as well as any references to “pharmacy” in, or in conjunction with, any written materials that ESSDS is not requested by Jazz Pharmaceuticals to send to Patients or any other party; provided that Jazz Pharmaceuticals shall not use ESSD’s or CuraScript’s name in connection with such references, except where necessary or appropriate under law or regulation.

  • Upon termination or expiration of this 2011 Master Services Agreement, for whatever reason, Jazz Pharmaceuticals shall have the right to transfer all Xyrem Success Program SOPs and Business Rules and the toll free Xyrem telephone number to another specialty pharmacy and/or distributor of its choice, and CuraScript and ESSDS shall cooperate with Jazz Pharmaceuticals in the transfer of such items to another qualified specialty pharmacy and/or distributor.

  • The Xyrem Success Program is a proprietary program to ensure the safe use of Xyrem and minimize the risk of abuse, misuse, and diversion of sodium oxybate.

  • Xyrem is available only by prescription from physicians enrolled in the Xyrem Success Program and is distributed through a single central pharmacy directly to patients.

  • Jazz Pharmaceuticals requires certain Patient Confidential Information in connection with the Xyrem Success Program.

  • As a condition of approval of Xyrem, the FDA mandated that we maintain a risk management and controlled distribution system, which we refer to as the Xyrem Risk Management Program, that was implemented at the time Xyrem was approved, which includes parts of the Xyrem Success Program, to ensure the safe distribution of Xyrem and minimize the risk of misuse, abuse and diversion of sodium oxybate.

  • If, during the term of this Agreement, the FDA no longer mandates single central pharmacy administration of the Xyrem Success Program and Orphan chooses to engage another distributor in addition to SDS (thus making SDS’ distributorship hereunder non-exclusive), Orphan shall provide SDS one hundred eighty (180) days written notice thereof.

  • The Xyrem Account Director will be designed as the single point of contact for Jazz Pharmaceuticals and will be responsible for optimizing the effectiveness of the enhanced Xyrem Success Program.

  • Specifically at issue is whether ANDAs referencing Xyrem must contain such information regarding those aspects of the Xyrem Success Program that constitute labeling and/or conditions of use.

  • Furthermore, in the event that Jazz Pharmaceuticals chooses to engage another distributor for commercial, non- clinical Product in addition to ESSDS (other than an Affiliate of ESSDS or CuraScript), CuraScript and ESSDS shall maintain the right to continue to provide Covered Services to any Patients enrolled in the Xyrem Success Program as of the date that CuraScript and ESSDS no longer maintain its exclusive pharmacy/distributor status.

Related to Xyrem Success Program

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