Development Plan and Development Budget. Promptly following the designation of a Collaboration Lead Compound pursuant to Section 3(b), the JDC shall initiate preparation of the development plan for the Development (the "Development Plan") and a budget (the "Development Budget") for proposed Development Costs (as defined in Section 3(f)). The initial Development Plan shall set time lines and priorities for the various Development activities through [ * ] and identify which Party, or whether a Third Party, is to be responsible for each activity. The budget for each development program shall include a detailed short-term budget covering all proposed Development Costs of [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Development Plan and Development Budget. Promptly following the designation of a Collaboration Lead Compound pursuant to Section 3(b), the JDC shall initiate preparation of the development plan for the Development (the "Development Plan") and a budget (the "Development Budget") for proposed Development Costs (as defined in Section 3(f)). The initial Development Plan shall set time lines and priorities for the various Development activities through [ * ] and identify which Party, or whether a Third Party, is to be responsible for each activity. The budget for each development program shall include a detailed short-term budget covering all proposed Development Costs of the program expected during the subsequent [ * ] (the "Short-Term Budget Period") of the Development process. Both Parties recognize that the Development Plan and the Development Budget represent projections only and will be subject to frequent changes. Each such Development Plan and Development Budget shall be updated as deemed appropriate by the JDC, but in no event less frequently than [ * ] and approved by the JDC not later than thirty (30) days prior to each [ * ] of each applicable calendar year.
Development Plan and Development Budget. Prior to commencing the Work (including any site work), Developer shall prepare a proposed development plan and development budget (as approved by the CRA, the Development Plan) for the Project and submit the same to the CRA for its approval, which approval may be granted or withheld by the CRA in its sole but reasonable discretion. The Development Plan shall include the following information, if not previously provided to CRA: (a) a description in reasonable detail of the development requirements; (b) a line item budget for the estimated cost of the construction of the Work based upon the eighty percent (80%) Construction Documents (as approved by the CRA, the “Development Budget”); (c) a construction schedule which shall be updated throughout construction and shall encompass design and engineering, and all of the trades necessary for the construction of the Work; (d) a description of the Developer Equity (including sources thereof and proof of funds); (e) such other information as the CRA may reasonably request; and (f) any relevant information provided by the CRA to the Developer. As used in this Agreement, the term Development Plan shall also include the approved Development Budget.
Development Plan and Development Budget. (a) The Development of the Product shall be governed by a global Development plan (“Development Plan”), and the costs and expenses relating to the Development of the Product shall be governed by a Development budget (“Development Budget”), the initial forms of which are attached as Exhibits 4.2(a)(i) and 4.2(a)(ii), respectively. Updates thereto made pursuant to Section 4.2(b) shall be prepared by the GPT, for approval by the JSC. Each Development Plan shall include without limitation details of all Clinical Trials to be conducted by the Parties to support Regulatory Approval in the Territory, and related time lines, as well as other material activities necessary for Development of the Product in the Territory, and shall describe the proposed overall program of Development for the Product in each applicable country, including without limitation all preclinical studies, toxicology, pharmacology studies, formulation, process development, clinical studies, and regulatory plans and other elements of obtaining Regulatory Approval in each applicable country. The Development Plan and the Development Budget shall be updated at least once (1) per year and shall cover the following three (3) year period. The Parties have prepared a portion of the initial Development Plan specifically relating to the Device and a portion of the initial Development Budget relating to the Device (“Device Budget”) as well as a portion of the initial Development Plan specifically relating to Formulated Amikacin and a portion of the initial Development Budget relating to Formulated Amikacin (“Drug Budget”), respectively, as of the Effective Date, which initial budgets are attached as Exhibits 4.2(a)(iii) and 4.2(a)(iv), respectively.
(b) The GPT shall, on an annual basis, propose updates to the Development Plans and Development Budgets (including, for clarity, the Device Budget and the Drug Budget) for the following calendar year. The GPT shall submit such updated Development Plans and Development Budgets to the JSC (with such Development Budgets first being submitted to the JFC for review and endorsement), for review and approval by September 30 of each calendar year for the following calendar year. The JSC shall provide comments on each such updated Development Plan or Development Budget, as applicable, within fifteen (15) days following their submission. Within thirty (30) days following such original submission, the JSC shall either approve the Development Plan and Development Budget ...
Development Plan and Development Budget. The Development of the Licensed Products shall be governed by a global development plan (“Development Plan”), and costs and expenses relating to the Development of Licensed Products shall be governed by a development budget (“Development Budget”). Within [***] after the Effective Date, AstraZeneca shall submit the Initial Development Plan and Development Budget to the DCC for approval in accordance with the terms of Section 3.4, Section 3.6
Development Plan and Development Budget. As early as necessary in each year beginning with the first full Fiscal Year after the Effective Date, the Parties shall update and prepare the U.S. Development Plan and Development Budget for the Product for the following Fiscal Year to take into account completion, commencement or cessation of U.S. Development activities not contemplated by the then-current U.S. Development Plan, and submit such proposed U.S. Development Plan to the JSC no later than November 1 of such year, as follows: (a) Affymax, in consultation with Takeda, shall update the U.S. Development Plan for Regulatory Approval of the Product in the Renal Indications; and (b) Takeda shall update the U.S. Development Plan for Regulatory Approval of the Product in the Oncology Indications in consultation with Affymax. The JSC shall have the right to approve updates to the U.S. Development Plan and Development Budget, subject to the final decision-making authority described in Section 2.5(c) above. The JSC shall endeavor to finalize its approval of each updated U.S. Development Plan by December 15 of each year.
Development Plan and Development Budget. (a) The Development of each Collaboration Product in the Co-Promotion Territory for each Development Indication and Additional Indication, if any, shall be governed by a development plan ("Development Plan") and development budget ("Development Budget"), which shall provide for Development of Collaboration Products for Development Indications and Additional Indications, if any, in the Co-Promotion Territory and, together with updates, shall (except as provided in Section 5.04) be prepared by CTI after discussion and consultation with ORTHO and the JCC, for Development Budget approval by the Steering Committee. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.)
(b) The Parties have agreed upon and approved the Initial Development Plan and Budget. After the completion of the Phase II AML Trial, CTI shall provide ORTHO with all of the raw data related to the Phase II AML Trial and a draft clinical trial report (which shall be compiled from a secured and audited database and shall include patient listing statistics, methods and procedures) prepared by CTI with respect to the Phase II AML Trial (such data and report being collectively referred to herein as the "AML Trial Information"). The AML Trial Information shall be accompanied by a draft revised Development Plan and Development Budget for the AML Indication. ORTHO shall have the right, exercisable upon delivery of written notice to CTI not later than sixty (60) days following the date that the AML Trial Information is presented to ORTHO, to continue Development of Collaboration Products for an AML Indication hereunder for the period after June 30, 1997. In the event that ORTHO makes such election, it shall pay to CTI an amount equal to sixty percent (60%) of all expenses that were incurred by CTI in connection with the Development of Collaboration Products for an AML Indication on or after the Effective Date to the date of determination, other than any such amounts that were included in the Initial Development Plan and Budget and previously paid on a 60% basis by ORTHO, plus interest on such amount at an annual rate equal to *****. If ORTHO elects to exercise its option pursuant to this Section 4.05(b) to continue Development of Collaboration Products for an AML Indication, then ORTHO shall make the AML Milestone Payments to CTI pursuant to Section 3.02(b) hereof as provided therein. If any of ...
Development Plan and Development Budget. Promptly following acceptance of a Designated Shared Compound, the Steering Committee, which, for this purpose and for the purposes set forth in Sections 3.8-3.10 and 3.23, shall also include an equal number of financial personnel from each party, shall initiate preparation of the development plan for the Pre-Clinical Development and Development of such Designated Shared Compound and Development of any resulting Shared Product (the DEVELOPMENT PLAN) and a budget (the DEVELOPMENT BUDGET) for proposed Development Costs therefor. The initial Development Plan for a Designated Shared Compound shall set time lines and priorities for the various Pre-Clinical Development and Development activities through Phase I Clinical Trials or Phase IIa Clinical Trials and identify which party, or whether a third party, is to be responsible for each activity. The Development Budget shall include a detailed short-term budget covering all proposed Development Costs of the Development Plan expected during the initial two (2) years of implementation of the Development Plan. Each Development Plan and Development Budget shall be approved by the Steering Committee [*]. Both parties recognize that the Development Plan and the Development Budget represent projections only and will be subject to frequent changes during the Pre-Clinical Development and Development process. Each such Development Plan and Development Budget shall be updated as deemed appropriate by the Steering Committee, but in no event less frequently than semi-annually, and approved, [*], by the Steering Committee not later than thirty (30) days prior to each January 1 and July 1 of each applicable calendar year.
Development Plan and Development Budget. Palvella will conduct the activities set forth in the Development plan set forth on Appendix C (the “Development Plan”) in accordance with the Development budget set forth on Appendix D (the “Development Budget”). Palvella may update or modify in good faith the Development Plan and the Development Budget from time to time in its sole discretion without Ligand’s consent, provided that such amendments or modifications relate to reasonable and customary Development activities and do not result, in the aggregate, in additional expenditures in excess of [***] of, or result in a reduction in expenditures by more than [***] of, the aggregate amount of expenditures set forth in the Development Budget set forth on Appendix D as of the Effective Date. Otherwise, Palvella must obtain Ligand’s consent before amending or modifying the Development Budget, with such consent not to be unreasonably withheld, delayed, or conditioned. Palvella will use the Upfront Payment solely to fund activities in accordance with the Development Plan and the Development Budget, each of which may be amended from time to time in accordance with this Section 2.2. Without limiting any other remedies available, if all Development of Product(s) in the Field in the Territory is ceased, Palvella will pay to Ligand an amount equal to [***].
Development Plan and Development Budget. The initial Development Plan and Development Budget through the end of 2009 that have been agreed to by the Parties as of the Execution Date are attached to this Agreement as Exhibit A and Exhibit B, respectively. The Parties acknowledge and agree that the Development Plan and Development Budget as of the Execution Date will need to be updated and augmented by the JDC on a quarterly basis and also from time to time in the discretion of the JDC. The purpose of the Development Plan is to (a) set forth a strategy and plan for development, manufacturing and Approval for the Product, (b) detail the responsibilities and activities of Isis and Genzyme with respect to the development of the Product and (c) specify the expected timing of such activities, including the estimated dates of the initiation and completion of such activities. The Development Budget contains the estimated costs associated with the tasks outlined in the Development Plan. The JDC (or directly by the written mutual agreement of the authorized representatives of the Parties) may amend the Development Plan and Development Budget at any time, but, in any event, the JDC will review and update the Development Plan and Development Budget by agreeing to a Development Budget for each calendar year during the Term not later than November 15th of the prior calendar year and prior to the commencement of each successive [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. calendar quarter during such calendar year. Any update or amendment to the Development Plan or Development Budget must be in writing. After the JDC has disbanded, if requested by either Party, Genzyme and Isis will meet as necessary at least annually on a mutually agreed schedule to review and evaluate progress under the Development Plan and expenditures relative to the Development Budget and to develop updates or amendments to the Development Plan and Development Budget, with decisions made by the Parties consistent with the principles contemplated for JDC decision making in Section 4.1.4 (Decision Making and Dispute Resolution).
