Common use of Development Plan and Budget Clause in Contracts

Development Plan and Budget. The CDRSC shall develop an annual development plan, which shall include preclinical and clinical plans and a budget (a "Development Plan") in respect of the Products consistent with the terms of this Agreement for each Year during the Co-Promotion Term. The CDRSC shall meet to discuss the first Development Plan within ninety (90) days after the Execution Date. A description of the overall development programs for development of the AMD Product and DME Product is attached as Exhibit 5.1(a), and a summary of the budgets for agreed upon Development Costs for such programs (respectively, the "AMD Agreed Development Costs" and the "DME Agreed Development Costs") are attached as Exhibit 5.1(b) to this Agreement. Each annual Development Plan may be updated throughout the Year as deemed appropriate by the CDRSC. Cumulative Development Costs for each of the AMD Product and DME Product shall not exceed the AMD Agreed Development Costs and the DME Agreed Development Costs, respectively, for such Products absent mutual consent of the Parties. The Parties' respective obligations with respect to Development Costs shall be as set forth in Section 8.1, provided that, unless otherwise agreed by the Parties, neither Party shall be obligated to pay for any Development Costs in excess of the AMD Agreed Development Costs or the DME Agreed Development Costs, respectively, except to the extent a Party exercises its final decision-making authority in accordance with Article 3 to approve such excess Development Costs over the objection of the other Party or otherwise unilaterally incurs such excess Development Costs, in which case the Party exercising such final decision-making authority or unilaterally incurring excess Development Costs shall be solely responsible for such excess Development Costs. The Parties acknowledge that the budgets set forth in Exhibit 5.1(b) do not cover preclinical Development Costs for periods after the end of 2003 and do not cover Development Costs for manufacturing process development and optimization. With respect to such Development Costs not covered by the budgets set forth in Exhibit 5.1(b), the Parties shall discuss reasonably necessary preclinical Development Costs for subsequent periods and Development Costs for manufacturing process development and optimization, and amend Exhibit 5.1(b) to cover such additional Development Costs.

Development Plan and Budget. The CDRSC shall develop an annual Attached hereto as Exhibit A is a preliminary development plan. Within [**] after the Effective Date, which shall include preclinical and clinical plans and a budget (a "Development Plan") in respect of the Products consistent with the terms of this Agreement for each Year during the Co-Promotion Term. The CDRSC Steering Committee shall meet to discuss develop and approve (i) a more detailed plan based on the first preliminary development plan for the Development Activities (the "DEVELOPMENT PLAN"), which sets forth (A) the tests, studies and other activities to be performed by the Parties through each Clinical Decision Point, (B) the Party responsible for each such activity, and (C) the period in which each such activity is expected to be started and completed, and (ii) a detailed budget for the Development Activities (the "DEVELOPMENT BUDGET"), which sets forth the projected costs and expenses for the Development Activities. The Parties currently contemplate that certain Development Activities and clinical trials will be conducted at New York Presbyterian Hospital/Cornell Medical Center with certain involvement of New Drug Associates, Inc., subject to Millennium's and Cornell Medical Center's respective internal policies, the guidelines and requirements of the FDA and all other Applicable Law. The Steering Committee shall review the Development Plan within ninety (90) days after and Development Budget at least annually and shall have the Execution Dateright to make such modifications or updates to the Development Plans and Development Budgets that it deems appropriate. A description No changes shall be made to a Development Plan or a Development Budget without the prior written approval of the overall development programs for development of Steering Committee. Notwithstanding the AMD Product and DME Product is attached as Exhibit 5.1(a)foregoing, and a summary of [**] performing the budgets for agreed upon Development Costs for such programs (respectivelyActivities, the "AMD Agreed Development Costs" and the "DME Agreed Development Costs") are attached as Exhibit 5.1(b) to this Agreement. Each annual Development Plan may be updated throughout the Year as deemed appropriate by the CDRSC. Cumulative Development Costs for each of the AMD Product and DME Product shall not exceed the AMD Agreed Development Costs and the DME Agreed Development Costs, respectively, for such Products absent mutual consent of the Parties. The Parties' respective obligations with respect to Development Costs shall be as set forth in Section 8.1a Development Plan or otherwise, provided thatwith respect to the [**] through the Clinical Decision Point for the [**] Product, unless otherwise agreed by Millennium expressly agrees otherwise; PROVIDED, HOWEVER, that the Parties, neither Party cost of such Development Activities shall be obligated to pay for any Development Costs in excess of the AMD Agreed Development Costs or the DME Agreed Development Costs, respectively, except to the extent a Party exercises its final decision-making authority in accordance with Article 3 to approve such excess Development Costs over the objection of the other Party or otherwise unilaterally incurs such excess Development Costs, in which case the Party exercising such final decision-making authority or unilaterally incurring excess Development Costs shall be solely responsible for such excess Development Costsnot exceed [**] Dollars ($[**]). The Parties acknowledge and agree that BZL's Development Activities shall be performed by Dr. Neil Bander and New Drug Associates, Inc. pursuant xx xxx XXX Agreement as assigned to Millennium pursuant to Section 3.3(c) and that the budgets complete cost and expense of NDA's performance of such activities and the other development work set forth in Exhibit 5.1(b) do not cover preclinical Development Costs for periods after the end of 2003 and do not cover Development Costs for manufacturing process development and optimization. With respect to such Development Costs not covered by the budgets this Agreement is set forth in Exhibit 5.1(b)the NDA Agreement. New Drug Associates, Inc. shall not devote more than [**] hours per Calendar Year during the Parties shall discuss reasonably necessary preclinical term of the NDA Agreement to the Development Costs Activities for subsequent periods and Development Costs for manufacturing process development and optimization, and amend Exhibit 5.1(b) to cover such additional Development Coststhe Radiolabel Product.

Development Plan and Budget. The CDRSC Development shall develop an annual be governed by a development plan, which and associated budget, that describes the proposed overall program of Development (the “Development Plan and Budget”). The Development Plan and Budget shall include preclinical a description of, without limitation: (i) all major Development tasks to be conducted before submission of filings for Regulatory Approval of a Collaboration Product for the Initial Indications; (ii) key Development objectives, expected associated resources, risk factors, timelines, manufacturing plans, go/no go decision points and relevant decision criteria; (iii) anticipated clinical plans trials to the extent known; and (iv) a reasonably detailed annual budget for the activities covered by such Development Plan and Budget. All Development Plans and Budgets (a "Development Plan"including without limitation the budgetary portion thereof) in respect of the Products must be consistent with the applicable Overall Plan and with the express terms and conditions of this Agreement. If any Development Plan and Budget is inconsistent with the applicable Overall Plan or the express terms and conditions of this Agreement, the express terms and conditions of this Agreement for each Year during or the Co-Promotion Termapplicable Overall Plan (as applicable) shall prevail. The CDRSC shall meet to discuss the first Lead Development Plan within ninety (90) days after the Execution Date. A description of the overall development programs for development of the AMD Product and DME Product is attached as Exhibit 5.1(a), and a summary of the budgets for agreed upon Development Costs for such programs (respectively, the "AMD Agreed Development Costs" and the "DME Agreed Development Costs") are attached as Exhibit 5.1(b) to this Agreement. Each annual Development Plan may be updated throughout the Year as deemed appropriate by the CDRSC. Cumulative Development Costs for each of the AMD Product and DME Product shall not exceed the AMD Agreed Development Costs and the DME Agreed Development Costs, respectively, for such Products absent mutual consent of the Parties. The Parties' respective obligations with respect to Development Costs shall be as set forth in Section 8.1, provided that, unless otherwise agreed by the Parties, neither Party shall be obligated determine whether to pay for allocate any Development Costs in excess of the AMD Agreed Development Costs or the DME Agreed Development Costs, respectively, except responsibilities to the extent a Party exercises its final decision-making authority in accordance with Article 3 to approve such excess Development Costs over the objection of the other Party or otherwise unilaterally incurs such excess Development Costsunder this Agreement, in which case but shall have no obligation to allocate any responsibilities to the Party exercising such final decision-making authority or unilaterally incurring excess Development Costs shall be solely responsible for such excess Development Costsother Party. The Parties acknowledge other Party shall have no obligation to participate directly in Development except with its consent, which it may withhold in its sole discretion. As used throughout this Agreement, “consistent with the (applicable) Overall Plan” means that the budgets particular plan and budget being compared to the applicable Overall Plan (i) describes only activities directed at Development for the Indications specified in the applicable Overall Plan, and (ii) contains a budget that, on an indication-by-indication basis, is within the budgetary limits set forth in Exhibit 5.1(bby the applicable Overall Plan for the phases(s) do not cover preclinical of Development Costs for periods after the end of 2003 and do not cover Development Costs for manufacturing process development and optimization. With respect to such Development Costs not covered by the plan and budget for the particular indication specified in the Overall Plan (considered together with plans and budgets set forth in Exhibit 5.1(bfor other years covering activities for the same stage of Development for such indication), the Parties shall discuss reasonably necessary preclinical Development Costs for subsequent periods and Development Costs for manufacturing process development and optimization, and amend Exhibit 5.1(b) to cover such additional Development Costs.