Phase 2B Study Design; CRMA Services Sample Clauses

Phase 2B Study Design; CRMA Services. The Parties shall meet as soon as reasonably practical, but no less than 120 days prior to enrollment of the first patient in the GENETIC-AF trial to discuss the GENETIC-AF trial Protocol and the design of the Phase 2B Study, including a substudy to monitor and analyze XX Xxxxxx (the “XX Xxxxxx Substudy”). The Parties shall negotiate in good faith to agree on the specific elements of the XX Xxxxxx Substudy and the CRMA Services for the XX Xxxxxx Substudy to be provided by Medtronic (“XX Xxxxxx Substudy Protocol”), which shall be signed by the parties and appended to this Agreement as Appendix B by August 15, 2013. It is not bad faith for Medtronic to refuse to agree to undertake obligations in the XX Xxxxxx Substudy Protocol that materially exceed the obligations it agrees to undertake in this Agreement. Unless otherwise agreed- to by the Parties, the Protocol, the XX Xxxxxx Substudy Protocol, and the CRMA Services shall contain the relevant elements set forth in this Article V. Once agreed upon by the Parties, the XX Xxxxxx Substudy Protocol, and the applicable elements of the GENETIC-AF trial Protocol shall not be varied without the agreement of Medtronic; provided, that the Steering Committee at all times retains discretion over the conduct of GENETIC-AF, including the discretion to make changes to the Protocol, the XX Xxxxxx Substudy Protocol, or the conduct of GENETIC-AF whenever it deems such changes advisable for any reason.
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Related to Phase 2B Study Design; CRMA Services

  • Development Plan As defined in Section 3.2(a).

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

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  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

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