Co-Development Plan definition

Co-Development Plan means a written Development plan intended to support Development and Regulatory Approval of [***] Molecules and [***] Products after the Opt-In in the Field worldwide, as may be updated and amended periodically in form and substance approved by the JSC in accordance with Section 5.1(a)(ii).
Co-Development Plan shall have the meaning set forth in Section 4.1.
Co-Development Plan means the annual Co-Development plan for the VEGF Products approved by the Joint Steering Committee, including the related Co-Development Budget.

Examples of Co-Development Plan in a sentence

  • Unless otherwise specified in a Co-Development Plan and Budget amounts reflected for a full year shall be deemed budgeted in equal amounts for each calendar quarter of such year.

  • Upon Sunesis’ exercise of the Co-Funding Option, the Parties shall form a product team with respect to each Co-Funded Product that shall report to the JDC, comprised of Biogen Idec and Sunesis personnel that will implement the further development and regulatory affairs with respect to that Co-Funded Product (each a “Product Team”) in accordance with the Co-Development Plan and Budget.

  • Each such further elaborated and refined Co-Development Plan shall be deemed a part of, and is hereby incorporated by reference in, this Agreement.

  • Such Co-Development Plan and Budget shall be comprehensive and shall fully describe at least the proposed activities related to ongoing preclinical studies, formulation, process development, clinical studies and regulatory plans, and other activities and timelines directed to obtaining the initial and subsequent Regulatory Approvals in each applicable country.

  • Such Co-Development Plan and Budget shall be comprehensive (as of the time of preparation and delivery hereunder) and shall fully describe at least the proposed activities and data related to [ * ], and other activities and timelines directed to obtaining the initial and subsequent Regulatory Approvals in each applicable country.


More Definitions of Co-Development Plan

Co-Development Plan means the plan for the performance of development and commercialization activities by the Parties in the Field, as may be amended from time to time by the Steering Committee, which plan, including all amendments, shall be attached hereto as Exhibit B.
Co-Development Plan means the world-wide plan prepared and managed by the JRDC and approved by the Parties for the Preclinical and the Clinical Development Period of Development Compounds as set forth in Section 11.1.
Co-Development Plan means a plan that details the Development activities to be conducted by OncoMed pursuant to this Agreement with respect to Biologic Collaboration Compounds included in a given Class as they arise during the Term after OncoMed elects to co-Develop a given Biologic Collaboration Compound pursuant to Section 3.8, and may include without limitation the following anticipated Development activities or events: [***]. The Co-Development Plan will include, without limitation, [***], and will be subject to Section 3.8.
Co-Development Plan means a program of work for the development of a Joint Selected Candidate; provided, that, for clarity, a “Co-Development Plan” will only be deemed to have been terminated, abandoned, or otherwise no longer being pursued in the event that Lilly has ceased, or taken a decision to cease, all, without any intention to resume any, activities with respect to all Research Compounds directed at the same Selected Target as the Joint Selected Candidate referred to in such plan prior to receipt of first Regulatory Approval for a Product that was the subject of such plan, regardless of whether Lilly describes a given Co-Development Plan as being “abandoned” or “replaced” by a subsequent plan for CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. one or more Research Compounds directed at the same Selected Target as the Joint Selected Candidate referred to in such plan; Co-Development Term is defined in Clause 7.6.1;
Co-Development Plan means, with respect to each Co-Developed Product, the written plan describing the joint Development activities to be carried out by both Parties over each Contract Year commencing with the date of exercise of the Co-Development Option in Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. accordance with Section 5.1.1 for each Co-Developed Product, broken down by Calendar Quarters, and which shall contain, inter alia, (a) the specific Development objectives, projected milestones, resource allocation requirements and activities to be performed over such period; (b) the Party responsible for such activities; (c) a timeline for such activities; (d) an estimate of the expected Co-Development Costs to be incurred over such period; (e) the expected Regulatory Filings to be required and prepared, and the expected timetable to budget for making such Regulatory Filings; (f) the manufacturing strategy, budget and proposed timelines for manufacturing scale-up, formulation, filling and/or shipping for each such Licensed Product, MAY Compound and Linker; and (g) a Co-Development clinical development plan. The Co-Development Plan shall be set forth in a written document jointly prepared by the Parties and approved by the JDC. Each amendment and/or update to the Co-Development Plan shall be set forth in a written document prepared by the Parties and approved by the JDC, shall specifically state that it is an amendment, modification or update to the Co-Development Plan and shall be attached to the minutes of the meeting of the JDC at which such amendment, modification or updated is approved by the JDC. Without limiting the nature or frequency of any other amendments or updates of the Co-Development Plan that may be approved by the JDC, the Co-Development Plan shall be updated at least once prior to the end of each Contract Year to describe the Co-Development activities to be carried out by each Party during the next Contract Year pursuant to this Agreement.
Co-Development Plan means the detailed work-plan agreed to by the Parties for the Phase II Clinical Study and related Co-Development with allocation of responsibilities between the Parties with respect to Co-Development under this Agreement and the agreed Budget therefor. The Co-Development Plan shall include specific anticipated costs, number and designation of FTES, and expected decision points and timelines of the Phase II Clinical Study and related Co-Development.
Co-Development Plan means a plan that details the Development activities to be conducted by OncoMed pursuant to this Agreement with respect to Biologic [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Collaboration Compounds included in a given Class as they arise during the Term after OncoMed elects to co-Develop a given Biologic Collaboration Compound pursuant to Section 3.8, and may include without limitation the following anticipated Development activities or events: [***]. The Co-Development Plan will include, without limitation, [***], and will be subject to Section 3.8.