Development Plan and Budget. The development plan (the "Development Plan") and the development budget (the "Development Budget") for the Development Activities relating to propofol are attached hereto as Exhibit B and Exhibit C, respectively. The Development Committee shall review the Development Plans and the Development Budgets at least monthly and shall have the right to make such modifications or updates to the Development Plans or Development Budgets that it deems appropriate. The Parties acknowledge and agree that the amounts set forth in the Development Budgets are estimates and, given the unpredictability of the Development Activities, there can be no assurances that the Development Activities can be completed within the Development Budgets, provided, however, that the Parties agree to use their Commercially Reasonable Efforts to adhere to the Development Budgets.
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. 12 4.4 Promotional Materials involving BioNumerik and Labeling...................................... 13 5.
Development Plan and Budget. The initial Development Plan and initial Budget agreed to by the Parties will be developed by the Parties with final review and approval by the Alliance Steering Committee. The Development Plan and Budget will be updated by the Alliance Steering Committee on at least a quarterly basis. Prior to the start of each calendar year, the Alliance Steering Committee shall meet to review and approve a Development Plan and Budget for the following calendar year. No material deviations (e.g., major changes in clinical study design, patient populations, clinical trial endpoints, or the analysis of such endpoints) from the Development Plan or Budget will occur without prior approval by the Alliance Steering Committee. The Development Plan will include the following elements: (a) a clinical trial program for the Product(s) in the Territory, (b) a Product Registration Plan, (c) a Publication Plan, and (d) a Distribution, Selling and Marketing Plan for the Product(s). No company sponsored clinical trial shall be commenced for the Product(s) in the Territory without the approval of the Alliance Steering Committee. The Budget detail will contain specific estimates of allocation of administrative and finance costs, country or region-specific allocation of "sales force time and effort" (as defined in Section 5.6), and country specific-profit and loss estimates.
Development Plan and Budget. 37 5.2 AMD Product and DME Product Development............................................................. 38 5.3 Development of Products for Additional Indications in the Field..................................... 38 ARTICLE 6 LAUNCH, CO-PROMOTION AND DETAILING................................................................. 39
Development Plan and Budget. Tenant shall prepare the initial Development Plan and Budget in connection with the Development (as may be modified from time to time hereunder, the “Development Plan and Budget”). Tenant will consult with Landlord in connection with the preparation of the initial Development Plan and Budget. Following Landlord’s approval of the initial Development Plan and Budget, Landlord and Tenant shall attach the same as Exhibit C to this Agreement. During the Term of this Agreement, Tenant shall use commercially reasonable efforts to comply with the terms and conditions of the Development Plan and Budget. Notwithstanding the foregoing, Tenant may exceed the line item amount allocated to any such expenditure as set forth in the Development Plan and Budget, without the approval by Landlord, provided the following conditions are satisfied: (a) such expenditure does not exceed the applicable line item (determined on an aggregate basis), by more than One Hundred Thousand Dollars ($100,000.00), or thirty percent (30%), whichever is less; (b) Tenant has recognized cost savings in other categories of the Development Plan and Budget of equal or greater amounts thereby resulting in no net overall increase in the Development Plan and Budget; and (c) any such expenditure or cost savings does not result in a material modification of the conceptual plan for the Improvements as set forth in the Development Plan and Budget.
Development Plan and Budget. During the Term, Receptos shall use Commercially Reasonable Efforts to Develop ABT-308 in accordance with the Development Plan and Budget and in compliance with the terms and conditions set forth in this Agreement. Any material changes to the Development Plan and Budget, including any material change to a clinical study protocol included thereunder, shall require prior written approval by AbbVie. In the event of a conflict between the Development Plan and Budget and this Agreement, the terms and conditions set forth in this Agreement shall govern.
Development Plan and Budget. If either Party (or its licensees or Sublicensees) wishes to Conduct one or more Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product in a Licensed Indication in the Licensee Territory and the United States or related Party Development Activities (other than the Initial Development Activities, or, in the case of a Collaboration Compound, other than the Development activities under the applicable Collaboration Candidate Development Plan and Budget), then such Party, through its representatives on the JDC, shall provide the other Party with a written summary of such proposed Clinical Study and related Party Development Activities and any Information with respect thereto. Each Party shall only propose such Clinical Studies that it believes in good faith are scientifically reasonable. If both Parties are interested in conducting such Clinical Studies and related Party Development Activities, then the Parties, through their representatives on the JDC, shall use good faith efforts to agree on a Development Plan and Budget with respect thereto, which plan shall assign responsibility for such Clinical Studies and related Party Development Activities between the Parties (such activities, “Joint Development Activities”). It is contemplated that all Joint Development Activities shall be structured so as to support the filing of Drug Approval Applications for the Licensed Product both in the Major Markets and the United States. The Parties shall Conduct Joint Development Activities in accordance with the terms and conditions of this Agreement and the applicable Development Plan and Budget. If only one Party is interested in Conducting specific Clinical Studies in support of obtaining or maintaining Regulatory Approval of a Licensed Product in the Licensee Territory or the United States or related Party Development Activities, or the Parties are not able to agree on a Development Plan and Budget with respect thereto, then the interested Party, or in the absence of agreement each Party, shall have the right to Conduct such Clinical Studies or related Party Development Activities as Unilateral Activities as and to the extent provided in Section 3.7.1.
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. Within 90 days of the Effective Date, the Development Committee shall approve the first annual Development Budget for the Development Program and define the specific tasks of each Party under the Development Program, which tasks shall be set forth in the "Development Plan." This first Development Budget shall set forth a budget through the end of the initial calendar year and through the end of the first twelve (12) month period of the Agreement. Thereafter, the Development Budget shall run on a calendar year basis. ** The Development Plan may be amended or modified by the Development Committee as necessary. MoliChem shall manage and control the production, purification and formulation of Moli1901 under the direction of the Development Committee. The Development Committee will agree upon the good manufacturing practices process and specifications of the final commercial product. The Development Committee shall manage and conduct all pre-clinical trials, trials supporting IND requirement and clinical trials, including adequate and well controlled Phase III clinical trials for Moli1901 for each of the countries where such studies are required for regulatory approval in such country. Other than as provided for in Section 3.5 of this Agreement, the Development Committee shall also manage all regulatory negotiations with all regulatory authorities in all countries worldwide.
