CRMA Services definition

CRMA Services means the collection and analysis by Medtronic pursuant to Sections 5.1-5.3 of this Agreement of cardiac rhythm data collected from patients while they are enrolled in the Phase 2B or Phase 3 portion of the GENETIC-AF trial through the use of Medtronic Devices implanted by physicians.
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Examples of CRMA Services in a sentence

  • If ARCA conducts the Phase 3 Portion of GENETIC-AF, Medtronic shall provide the CRMA Services for the Phase 3 Portion, subject to all the applicable terms and conditions of this Agreement, with the following modifications.

  • Medtronic, however, agrees to file and prosecute any regulatory application or submission that in Medtronic’s sole judgment is required by any Regulatory Authority in order for Medtronic to perform the CRMA Services required by this Agreement.

  • Notwithstanding the foregoing, each Party shall notify the other Party of any oral or written communications to or from the FDA on matters relating to the CRMA Services, and shall provide the other Party with copies of any such communications reasonably promptly and give the other Party the right to review and participate in any response to any such communications.

  • The Parties shall negotiate in good faith to agree on the specific elements of the ▇▇ ▇▇▇▇▇▇ Substudy and the CRMA Services for the ▇▇ ▇▇▇▇▇▇ Substudy to be provided by Medtronic (“▇▇ ▇▇▇▇▇▇ Substudy Protocol”), which shall be signed by the parties and appended to this Agreement as Appendix B by August 15, 2013.

  • The CRMA Committee may have up to eight members and may add, as appropriate, representatives of any Third Party vendor (if any) retained by Medtronic to assist in the CRMA Services under this Agreement.

  • Medtronic has no obligation to provide CRMA Services in connection with Competitive Devices.

  • Unless otherwise agreed- to by the Parties, the Protocol, the ▇▇ ▇▇▇▇▇▇ Substudy Protocol, and the CRMA Services shall contain the relevant elements set forth in this Article V.

  • Medtronic Canada does not have the ability to provide the collection and analysis services contemplated by the CRMA Services with respect to study subjects enrolled by investigational sites in Canada, though Medtronic does have that ability per the Collaboration Agreement, including with respect to study subjects enrolled by Canadian investigational sites.

  • Medtronic will consult with, and allow participation by ARCA on a reasonable basis regarding the content of any submissions to the FDA related to the CRMA Services, and will provide ARCA with the opportunity to attend or participate in all substantial contacts, including meetings and conference calls, between Medtronic and the FDA related to the CRMA Services.