Research and Development Plan. The RESEARCH AND DEVELOPMENT PLAN (Attachment A to this SCHEDULE) contains: • Research and evaluation activities to be performed by each Party in detail, including locations for such activities • Timelines of such activities • Goals, expected results and deliverables • Milestones and go/no-go decision points, if applicable • FTEs
Research and Development Plan. Attached hereto as Exhibit C is the initial version of the Research and Development Plan (as it may be modified from time to time, the “Research and Development Plan”) that sets forth the plan for the Research activities expected to be performed by each Party pursuant to this Agreement. The Research and Development Plan may be amended by the ERC from time to time in accordance with the provisions of Article 6.
Research and Development Plan. To commercialization: Overall research and development requirements for commercial sale Key milestones and projected dates Estimated total development time and expenditure For the next 12 months: Annual research and development objectives Annual timeline and budget, including to whom activities will be sublicensed or subcontracted Milestones for annual research and development and projected dates
Research and Development Plan. Within sixty (60) days following execution of this Agreement, LICENSEE shall provide to FHCRC a written research and development plan and business plan for introducing LICENSED PRODUCTS into commercial use.
Research and Development Plan. The Research and Development Plan shall (a) include a broad non-binding overview of the first [***] of the planned Development program (specifying in reasonable detail all material Development activities) to generate the preclinical, clinical, CMC, regulatory and other information required for submitting a marketing authorization application for Regulatory Approval for the Candidate or Product and to achieve such Regulatory Approval for the Candidate or Product in one or more selected country(ies) of the Territory; (b) include a more detailed and binding part of the plan for the initial binding period described in Section 6.1, which will be updated in accordance with Section 6.1; and (c) set forth those obligations assigned to each Party with respect to the performance of the Development activities contemplated by such Research and Development Plan.
Research and Development Plan. The initial plan for the research and Development of the Product in the Field in the Licensed Territory, which includes a responsibility matrix allocating responsibility between the Parties, is attached hereto as Exhibit C (such plan, as amended from time to time as provided herein the “Research and Development Plan”). The JSC shall oversee the Development of the Product in the Field in the Licensed Territory according to the Research and Development Plan. The Research and Development Plan shall provide generally for a budget for the internal costs and out-of-pocket expenses to be incurred by Visterra in conducting activities under the Research and Development Plan and agreed upon by the Parties (including any reimbursements to be paid by either Party) and assignment of responsibilities between the Parties for the various activities to be undertaken under the Research and Development Plan, including the following: [**]. During the Term, the JSC shall review the Research and Development Plan at least [**] and comment upon such Research and Development Plan on an ongoing basis as necessary and the Parties will amend such Research Plan to the extent necessary. The then-current Research and Development Plan shall at all times contain at least that level of detail and cover at least the same matters (to the extent applicable) as the initial Research and Development Plan.
Research and Development Plan. The Research and Development Plan sets forth the plan for the Research activities expected to be performed by each Party pursuant to this Agreement. The Research and Development Plan may be amended by the ARC from time to time in accordance with the provisions of Article 6.
Research and Development Plan. As soon as practicable after the Effective Date but no later than June 30, 2004, Defiante shall deliver or have delivered to RegeneRx a written tentative outline of the activities that Defiante plans to undertake with respect to the research and development activities and clinical trials associated with the development of any Finished Products, and in anticipation of the Sales and eventual production of any Finished Products, whenever appropriate. The outline shall be updated annually on the Effective Date during the Term or at such other times, such as but not limited to the Management Meetings under Section 6.9, as the parties may mutually agree.
Research and Development Plan. The Research and Development Plan for the Product (including tasks, allocation of responsibilities, estimated development timelines, and estimated development budgets) is set forth on Exhibit A. The Parties may periodically modify the Research and Development Plan, within the scope of and in a manner consistent with this Agreement, further detail the responsibilities of each Party within the general scope of responsibilities set forth herein, and revise the Research and Development Plan accordingly. The Parties acknowledge that the timelines, dates and budgeted costs set forth in the Research and Development Plan are good faith estimates. However, in the event that an estimated development timeline will not be met, the Party with responsibility for meeting that timeline shall notify the other Party and the Parties shall work together in good faith to bring the project back on schedule. Each Party shall be responsible for its own cost overruns, if any.
Research and Development Plan. (a) An initial Research and Development Plan, attached hereto as Exhibit D, sets forth certain Development (including Manufacturing) activities to be performed by each of the Parties during the Research Term directed to one or more Compounds identified as part of the Current Lead Series on Exhibit G attached hereto (such Compounds may be referred to herein as the “Current Lead Series”). Following the Effective Date and during the Research Term, the Parties shall mutually agree on any additional Development activities to be performed by the Parties beyond those necessary for the Current Lead Series to attain the Development Candidate Selection Criteria, which Development activities shall be included in the Research and Development Plan. Such additional activities may include the Development of companion diagnostics and biomarkers as the Parties deem appropriate. Subject to EPIZYME’s exercise of the applicable Profit-Sharing Option and the terms of any applicable Joint Development and Commercialization Agreement, the Research and Development Plan shall set forth, and EISAI will have the sole right and responsibility for, all Development activities following the end of the Research Term unless the Parties otherwise mutually agree.
