Co-Development Plan Sample Clauses

Co-Development Plan. 3.1 The parties to this Agreement hereby agree to cooperate in the development and commercialization of PB. BTP will be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable USA and Canadian regulatory authorities, and all regulatory filings in the USA and Canada will be in the name of BTP. BOP will be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable regulatory authorities other than in the USA and Canada and all such filings shall be in the name of BOP.
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Co-Development Plan. The initial Co-Development Plan shall be approved by the Steering Committee within sixty (60) days after the Effective Date and shall be attached hereto as Exhibit B. The Co-Development Plan shall describe the comprehensive worldwide development plan and budget for the Co-Development Product in the Field, including, without limitation, the overall plan for clinical trials, regulatory approvals and commercialization activities, and shall be consistent with Clause 2.2 below. As part of the budget, the Steering Committee shall agree on an annual budget for development and Marketing of the Co-Development Product in the CAT Territory and Dyax Territory, and, neither CAT nor Dyax shall expend Co-Development Costs for development and Marketing in excess of one hundred and ten percent (110%) of the amount budgeted, without the prior written approval of the Steering Committee.
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Co-Development Plan. The Parties accept that each Co-Development Plan will change and develop as the applicable Joint Selected Candidate progresses through development, Clinical Trials and to Regulatory Approval. The JDC shall be responsible for reviewing and amending each Co-Development Plan as necessary, however it is understood that Lilly will be responsible for preparation of any amendments (including such amendments as may result from proposals initially made by Immunocore either directly to Lilly or through the JDC). Lilly will update each Co-Development Plan (including the budget set out therein) in accordance with Lilly’s standard internal budgeting procedures, but in any event to cover the anticipated costs of the next phase of Clinical Trials. Such budget will be discussed at the JDC and approved at the JDC. Both Parties will use Commercially Reasonable Efforts to progress the Co-Development Plan and to develop at least one Joint Selected Candidate in each Co-Development Plan through Clinical Trials and through to commercialization. On a Co-Development Plan by Co-Development Plan basis, at any point during the Co-Development Term, Lilly may decide in its discretion to add a new Indication to the Co-Development Plan. Prior to such introduction, Lilly will discuss with Immunocore addition of such new Indication and associated changes to the Co-Development Plan and this Agreement, if any (it being understood by the Parties that neither Party has an obligation to amend this Agreement).
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Co-Development Plan. 5.1.1 Within *** after the Acceptance Date (or such longer time as mutually agreed by the Parties in writing) with respect to a given Selected Target, the JPT shall draft and agree upon a Co-Development Plan for the generation of Candidates directed to each Party’s Selected Target, which plan is intended to generate the data necessary to support an IND filing for such Party’s Joint Selected Candidate. No activities will be performed in connection with a proposed Co-Development Plan (and accordingly, no costs will be incurred under Clause 10.2) before the applicable JPT has agreed upon such Co-Development Plan. Each of the two Co-Development Plans shall:
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Co-Development Plan. All references to the “Development Plan” and “Development Plan Budget” in the Agreement, unmodified by this Exhibit A, shall apply solely with respect to the Jazz Territory. In addition, except with respect to the definitions of “Development Plan” and Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Related to Co-Development Plan

  • 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.

  • 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.

  • 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.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

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

  • Marketing Plan (1) No later than six (6) months prior to the date rehabilitation of the Development is projected to be complete, Borrower shall submit to the County for approval its plan for marketing the Development to income-eligible households as required by this HOME Regulatory Agreement (the "Marketing Plan"). The Marketing Plan must include information on affirmative marketing efforts and compliance with fair housing laws and 24 C.F.R. 92.351(a).

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members.

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

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