CMC Plan Sample Clauses

CMC Plan. Subject to the terms and conditions of this Agreement, Denali shall also use [***] to perform all manufacture process development work required for Denali to Manufacture (or have Manufactured) the Option Products that Denali is obligated to supply under Section 8.2.1 (Supply Requirements). Denali shall perform such manufacture process development activities for each Option Program pursuant to, and contingent upon, a written manufacture process development plan [***] that sets forth all material process development work to be conducted for each Option Product, the timeline for performance thereof, and the Specifications (each, a “CMC Plan”). The CMC Plans shall include all process development activities required for the Manufacture of [***] for the first Option Product that is subject to each Option Program for which Biogen has exercised its Option. Each CMC Plan shall also set forth (a) a detailed budget for such process development work, including both internal costs (at the FTE Rate) and out-of-pocket costs (each, a “CMC Budget”) and (b) the quantities of the applicable Option Product to be ordered by Biogen and the estimated delivery date for such Option Product, which shall be consistent with the forecast provided by Biogen in accordance with a forecasting schedule to be agreed by the Parties in the Supply Agreement. The Parties shall collaboratively prepare the CMC Plan (including the CMC Budget) for such Option Program in accordance with Section 5.1 (Development and Manufacturing Activities during the Option Term) and in any case no later than [***].
Sample 1
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CMC Plan. The CMC Plan in effect as of the Restatement Date is attached hereto as Schedule 1.60. Either Party, directly or through its representatives on the JDC, may propose amendments to the CMC Plan from time to time as appropriate, including in light of changed circumstances.
Sample 1

Related to CMC Plan

  • 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.

  • Drug Plan 42.01 The parties agree to the continuation of the Drug Care plan as follows:

  • 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.

  • Meal Plan The Student who resides in a university residence hall is required to purchase a full residential dining plan (commuter plans are not acceptable). The Student who resides in Bobcat Village may choose either a residential or a commuter plan, but is not obligated to make a dining plan purchase due to availability of kitchen in each apartment unit.

  • Profit Sharing Plan Under the Northrim BanCorp, Inc. Profit Sharing Plan (the “Plan”), Executive shall be eligible to receive an annual profit share based on performance as defined by the Board of Directors. Executive will be classified in the Executive tier under the Plan’s Responsibility Factors. If Employer is required to prepare an accounting restatement due to “material noncompliance of the Employer,” the Employer will recover from the Executive any incentive compensation during the three (3) years prior to the date of the restatement, in excess of what would have been paid under the restatement. Executive’s signature on this Agreement authorizes Employer to offset or deduct from any compensation Employer may owe Executive, any excess payments (in whole or in part) that Executive may owe Employer due to such restatement(s).

  • Section 125 Plan The Trustees shall continue the Section 125 plan to allow pretax treatment of the employee’s share of health and dental insurance premiums. The plan will be available as soon as practicable, but no later July 1, 1998. The plan will be amended to include a medical reimbursement account and a dependent care reimbursement account to be available for enrollment no earlier than July 1, 2003, but no later than December 31, 2003.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Transition Plan In the event of termination by the LHIN pursuant to this section, the LHIN and the HSP will develop a Transition Plan. The HSP agrees that it will take all actions, and provide all information, required by the LHIN to facilitate the transition of the HSP’s clients.

  • HEALTH AND WELFARE PLAN 16.01 The Employer agrees to pay the amount as set out in the Wage Schedules for all hours worked for each employee towards the Insurance Plan administered by the CLAC Health and Welfare Trust Fund.

  • Plan The Award and all rights of the Participant under this Agreement are subject to the terms and conditions of the provisions of the Plan, incorporated herein by reference. The Participant agrees to be bound by the terms of the Plan and this Agreement. The Participant acknowledges having read and understanding the Plan, the Prospectus for the Plan, and this Agreement. Unless otherwise expressly provided in other sections of this Agreement, provisions of the Plan that confer discretionary authority on the Board or the Administrator do not (and shall not be deemed to) create any rights in the Participant unless such rights are expressly set forth herein or are otherwise in the sole discretion of the Board or the Administrator so conferred by appropriate action of the Board or the Administrator under the Plan after the date hereof.

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