Celgene Co-Co Development Plan definition

Celgene Co-Co Development Plan means, on a Co-Co Product-by-Co-Co Product basis, the plan for the Development of such Co-Co Product (and corresponding the Co-Co Candidate and if applicable Co-Co Diagnostic Products) in the Territory, as prepared by Celgene for Co-Co Product for ROW Administration and U.S. Administration and approved by the JSC in accordance with Section 2.3.1.
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Examples of Celgene Co-Co Development Plan in a sentence

  • The JSC will set the required form and contents of the Celgene Co-Co Development Plan, and will review and approve each Celgene Co-Co Development Plan.

  • Promptly after the Celgene Lead Effective Date, and concurrently with the preparation of the Celgene Co-Co Development Plan pursuant to Section 2.3.4, the Parties shall cooperate to prepare the Celgene Co-Co Development Budget.

  • Subject to subsection (a) and Sections 2.3.2, 2.3.3 and 2.3.5, all reasonable Direct Costs (including Out-of-Pocket Costs) arising from either Party’s conduct of Development with respect to the Celgene Co-Co Program in accordance with the Celgene Co-Co Development Plan and the Celgene Co-Co Development Budget shall be included as a Worldwide Development Cost and be subject to the Development Cost Share in accordance with Schedule 2.3.4.

  • Each Party, directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Develop and Commercialize Co-Co Products in the Field for U.S. Administration and otherwise perform its obligations under the Celgene Co-Co Development Plan in the United States.

  • In addition, either Party may reasonably request at any time that the JSC consider and approve other updates to the Celgene Co-Co Development Plan for Development activities to support Regulatory Approval on a global basis, including any Celgene Co-Co Additional Study that the Parties agree to conduct pursuant to Section 2.3.2(c)(1).

  • Subject to the Development Lead Party’s right to make a final decision pursuant to Section 4.2.5 of the Master Collaboration Agreement, the Celgene Co-Co Development Plan shall incorporate any reasonable comments made by Jounce in relation to the Development of Co-Co Products either within or outside the United States.

  • Within [***] days after the end of each Calendar Quarter following the Celgene Lead Effective Date (or the determination by the JSC of the scope of Development activities to be conducted by the Parties under the Celgene Co-Co Development Plan, if later), each Party shall submit its Development Cost Report for the previous Calendar Quarter to the JSC.

  • Promptly following the Celgene Lead Effective Date, the JSC shall agree upon a form of cost report to be prepared and submitted by each Party to the JSC on a Calendar Quarterly basis setting forth the costs incurred by each Party in conducting Development activities in accordance with the Celgene Co-Co Development Plan and the Research budget in the previous Calendar Quarter (the “Development Cost Report”).

  • Sublicensees, will use Commercially Reasonable Efforts to Develop and Commercialize Co-Co Products in the Field for ROW Administration and otherwise to perform its obligations under the Celgene Co-Co Development Plan in the ROW Territory.

  • Within [***] days following the end of each Calendar Quarter, each Party shall provide the other Party a report of actual Worldwide Development Costs incurred by such Party during such Calendar Quarter in accordance with the Celgene Co-Co Development Plan, together with reasonable supporting evidence of such Worldwide Development Costs.

Related to Celgene Co-Co Development Plan

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Plans has the meaning set forth in Section 3.2.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Program means the implementation of the development plan.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Development Phase means the period before a vehicle type is type approved.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.