Common use of Development Plan and Budget Clause in Contracts

Development Plan and Budget. As of the Effective Date, the Parties have agreed on an initial Development Plan and Development Budget (each as defined below), which is set forth in Exhibit J of the Correspondence. After the Effective Date, for the Development Candidate listed in Exhibit J of the Correspondence, and at the time any other SHP2 Inhibitor is designated as a Development Candidate by the JRDC, the JRDC shall prepare and approve a Development plan for Products containing such SHP2 Inhibitor through Regulatory Approval of the Product from the FDA, EMA, or PMDA, as applicable, that includes the items described below (the “Development Plan”). The Development Plan for each Product shall set forth the timeline and details of: (i) all clinical Development activities to be conducted by the Parties that are designed to generate data sufficient to present to the FDA, EMA, and PMDA or other Regulatory Authority at the Pre-Registrational Meetings; (ii) the protocol synopsis for each Clinical Trial included in such Development Plan; (iii) a Manufacturing plan for the Manufacturing of the Product for such Clinical Trials; (iv) all additional clinical Development activities to be conducted by the Parties that are designed to generate data sufficient to seek Regulatory Approval of the Product from the FDA, EMA, or PMDA, as applicable, for the indication(s) to be pursued; (v) any other Development activities to be performed in order to obtain Regulatory Approval by the FDA, EMA, PMDA or the Regulatory Authority of any other jurisdiction; (vi) a detailed budget setting forth the estimated RevMed R&D Costs to be incurred in connection with such activities (the “Development Budget”); and (vi) the Party responsible for conducting each Development activity under such Development Plan.

Development Plan and Budget. As (a) The Development of all Collaboration Compounds shall be governed by a development plan that describes the Effective Dateproposed overall program of Development, including (i) an allocation of responsibilities between the Parties have agreed on an initial Development Plan for implementation; (ii) the criteria by which the JSC will identify Backup Compounds for further study and Development Budget possible Development; (each as defined below), iii) the criteria by which is set forth in Exhibit J of the Correspondence. After the Effective DateJSC will, for the Development Candidate listed in Exhibit J of the Correspondenceeach Backup Compound submitted for evaluation by Archemix, and at the time any other SHP2 Inhibitor is designated determine whether to either designate it as a Development Candidate by the JRDCCompound in accordance with Section 4.5 or reject such Backup Compound for Development at that time, the JRDC shall prepare and approve a (iv) detailed provisions for all authorized Development plan for Products containing such SHP2 Inhibitor through Regulatory Approval of the Product from the FDA, EMA, or PMDA, as applicable, that includes the items described below Costs to be incurred (the “Development PlanPlan and Budget”). The Development Plan for each Product and Budget shall set forth the timeline and details include a description of, without limitation: (i) all clinical major Development activities tasks to be conducted by the Parties that are designed to generate data sufficient to present to the FDA, EMA, and PMDA or other before submission of filings for Regulatory Authority at the Pre-Registrational MeetingsApproval of a Collaboration Product for a particular indication; (ii) the protocol synopsis for each Clinical Trial included in such key Development Planobjectives, expected associated resources, risk factors, timelines, manufacturing plans, go/no go decision points and relevant decision criteria; and (iii) a Manufacturing plan anticipated clinical trials to the extent known. (i) Before payment of the ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ is the designated “Lead Development Party” for each Collaboration Compound subject to Section 2.4(a). The JSC may decide to assign the other Party as Lead Development Party at any time. The Lead Development Party shall be responsible for preparing and submitting each Development Plan and Budget for approval by the JSC, and directing the performance under the Development Plan and Budget. (ii) After payment of the Phase 2 Milestone, the JSC shall assign one of the Parties as the Lead Development Party for each Collaboration Compound. The Party assigned as the Lead Development Party shall prepare and submit for approval by the JSC the Development Plan and Budget for the Manufacturing Collaboration Compound so assigned. The Lead Development Party shall also oversee performance under the Development Plan and Budget for the assigned Collaboration Compound. The JSC shall decide upon, pursuant to Section 2.4, the responsibilities, procedures and Development Costs outlined in the Development Plan and Budget submitted by the Lead Development Party. (b) Each Party shall be responsible for carrying out its assigned activities in accordance with the approved Development Plan and Budget. (c) The detailed description of all authorized Development Costs to be incurred, as described in the Development Plan and Budget, plus a permitted overrun of 10% thereof, shall constitute the maximum Development Costs to be incurred thereunder in each calendar year. If at any time while conducting the assigned activities in accordance with the approved Development Plan and Budget, either Party determines that the authorized Development Costs to be incurred for a particular calendar quarter or calendar year are expected to exceed the costs set forth in the Development Plan and Budget for such budget quarter or budget year by ten percent (10%) or more, the identifying Party shall convene immediately a special meeting of the Product for such Clinical Trials; JSC to review the matter and make a decision thereon, pursuant to Section 2.4. (ivd) all additional In addition to the approval of the annual Development Plan and Budget, the JSC shall specifically approve, pursuant to Section 2.4, each clinical trial before its Commencement, including without limitation its design, size, entry criteria, endpoints, and data collection procedures. (e) The Initial Development Plan and Budget shall set forth: (i) the Development activities to be conducted by the Parties that are designed to generate data sufficient to seek Regulatory Approval of the Product from the FDA, EMA, or PMDA, as applicable, for the indication(syear 2004; and (ii) the Development Costs for the year 2004. Starting in the year 2004, the Lead Development Party shall prepare and submit to be pursued; (v) any other the Parties, by September 1 of each calendar year, an updated Development Plan and Budget, that includes a detailed description of all Development activities to be performed in order to obtain Regulatory Approval by during the FDAfollowing calendar year, EMA, PMDA or the Regulatory Authority of any other jurisdiction; (vi) and a detailed budget setting forth the estimated RevMed R&D description of all authorized Development Costs to be incurred in connection during the following calendar year. The Party receiving such draft Development Plan and Budget shall provide comments on each such updated Development Plan and Budget within 30 days following its submission to them. The JSC shall then meet and confer as necessary to decide on the final Development Plan and Budget for the forthcoming calendar year, with such activities (the “Development Budget”); and (vi) the Party responsible for conducting each Development activity under such Development Planobjective of reaching that decision no later than November 15.

Development Plan and Budget. As (a) The Parties shall conduct all Development of Products in the Field in the Territory in accordance with a written plan prepared by the Committee (each such plan, as updated or amended from time to time in accordance with Section 4.6,“a "Development Plan and Budget"). (b) Attached as Schedule C is the Parties’ initial non-binding working development plan for the first ninety (90) days after the Effective Date, which may be modified or amended by the Parties have agreed on Parties. The initial Development Plan and Budget for the first Product for the Initial Indication, which includes the Development strategy, allocation of responsibility, and Development Costs in connection therewith to be conducted will be prepared and approved by the JSC within ninety (90) days following the Effective Date. The JSC shall prepare an initial Development Plan and Budget for other Products at a time mutually agreed by the Parties. (c) Each Development Plan and Budget will set out: (each as defined below), which is set forth in Exhibit J i) the identity of the Correspondence. After the Effective Date, Product and each indication for Development; (ii) a coordinated Development strategy for the Development Candidate listed in Exhibit J of the Correspondence, and at the time any other SHP2 Inhibitor is designated as a Development Candidate by the JRDC, the JRDC shall prepare and approve a Development plan for Products containing such SHP2 Inhibitor Product through Regulatory Approval in the Territory, including a timeline and reasonably detailed description of the Product from Development program; (iii) the FDA, EMA, or PMDA, as applicable, that includes allocation of responsibility between the items described below (the “Development Plan”). The Development Plan Parties for each Product shall set forth the timeline and details of: (i) all clinical Development activities to be conducted by that the Parties that are designed agree to generate data sufficient to present to the FDA, EMA, and PMDA or other Regulatory Authority at the Pre-Registrational Meetings; conduct for such Product; (ii) the protocol synopsis for each Clinical Trial included in such Development Plan; (iiiiv) a Manufacturing plan for clinical supply of such Product until receipt of Regulatory Approval; which shall provide, among other things, that GreenLight, if it so elects, is the sole and exclusive manufacturer for any Manufacturing of the activities needed with respect to any such Product for such (each, a “Clinical TrialsManufacturing and Supply Plan”); (iv) all additional clinical Development activities to be conducted by the Parties that are designed to generate data sufficient to seek Regulatory Approval of the Product from the FDA, EMA, or PMDA, as applicable, for the indication(s) to be pursued; and (v) any other a good faith estimated budget for all Development activities to be performed in order to obtain Regulatory Approval activities, including the Development Costs for such Product and the number of FTEs committed by the FDA, EMA, PMDA or the Regulatory Authority of any other jurisdiction; (vi) a detailed budget setting forth the estimated RevMed R&D Costs to be incurred in connection with such activities (the “Development Budget”); each Party and (vi) the Party responsible for conducting each Development activity under such Development Plananticipated Out-of-Pocket Costs.