Development Plan Updates. The JSC shall periodically (or at the request of one of the Parties) review the then-current Development Plan, and if the JSC determines an amendment is needed to the then-current Development Plan, the designated member(s) of the JSC shall collaborate to prepare an amendment to the then-current Development Plan, for review, comment and approval by the JSC. Such amended Development Plan will reflect any changes to the Development of a Product in the Field. Once approved by the JSC in writing or by approved meeting minutes, the amended Development Plan becomes effective and supersedes the previous Development Plan as of the date of such approval.
Development Plan Updates. From time to time during the Term, but no less frequently than [***], the JSC will review and, if needed or reasonable to do so, will update the Development Plan (including each Development Budget set forth therein), including to contemplate the performance of additional clinical trials or additional Development or Manufacturing activities under the Development Plan for the Selected Antibodies. Each such update to a Development Plan will take into account, as applicable, emerging data, regulatory input, and other issues that may arise during the course of performance of activities under such Development Plan. The JSC will review, discuss, and determine whether to approve each such update, and upon the JSC’s approval thereof, each update to a Development Plan or Development Budget will be documented in writing and signed by each Party’s representatives to the JSC. Thereafter, such updated Development Plan and Development Budget will be deemed to supersede the prior version.
Development Plan Updates. Following the initiation of a Development Plan for a Product for an Indication, the Development Plan shall be amended or updated on at least an annual basis no later than October 1 of the relevant calendar year, and more often as the Steering Committee may reasonably determine, during a Development Plan Term. Each amended or updated Development Plan shall cover the three (3) calendar year period following its approval by the Steering Committee. All updated or amended Development Plans shall be filed with the minutes of the Steering Committee upon approval by the Steering Committee. Until a new or amended Development Plan is approved by the Steering Committee, the previous Development Plan shall remain in effect.
Development Plan Updates. In addition to updates to the Development Plan as described in Section 4.2, the Development Plan will be updated from time to time by the JDT, but not less than annually, to incorporate any activities as may be required in order to achieve the purpose of the Development collaboration described in Section 4.1. Neither Party shall unreasonably withhold, condition or delay approval with respect to amendments to the Development Plan required by the EMA. Each update to the Development Plan shall contain at least the following information with respect to the Product within the Field for the Territory:
Development Plan Updates. At least two (2) weeks in advance of the first meeting of the JSC in each calendar year, Nuance shall provide Verona with a written update of the Development Plan, including any amendments thereof. Any updates or amendment of the Development Plan shall be submitted to and approved by the JSC under Section 3.02(a).
Development Plan Updates. The Development Plan as of the Effective Date contains (i) an outline and overview of CoTherix’s anticipated Product Development program for the Territory, (ii) descriptions of each step (or potential series of steps) and an estimated time-line for each such step anticipated to be achieved by CoTherix and its Affiliates and Sublicensees with respect to the Development of, and obtaining Regulatory Approval for, each Product in the Territory in the upcoming year and (iii) an outline and overview of each anticipated Clinical Trial in the upcoming year (including, without limitation, approximate ranges of the total number of subjects, anticipated control comparative drug(s), approximate ranges of dosage and dose regimen, general descriptions of anticipated subject diagnosis and main criteria for inclusion, and anticipated endpoints (primary, secondary)). The initial Development Plan reflects the Parties’ expectations as of the Effective Date of the major elements of a Commercially Reasonable program for Development of each Product within the Territory. However, the Parties recognize and agree that as greater data is obtained, as CoTherix proceeds with the program, and as outside factors (such as the intellectual property landscape, the regulatory standards and framework, and the competitive landscape) evolve, the Development Plan may come to no longer reflect a practicable, Commercially Reasonable plan, it may need to be updated. In that case, either Party may propose an update or amendment to the Development Plan to the Joint Technical Committee. (To be clear, this possibility to update shall not be used to make the Development Plan more detailed; instead this possibility to update is intended to be used to respond to the circumstances and the greater information that has been obtained since the Effective Date.) The Joint Technical Committee shall promptly discuss any proposed updates or amendments. It is understood by the Parties that any amendment or update to the Development Plan shall be done only if the Joint Technical Committee determines such an amendment or update is desirable or necessary.
Development Plan Updates. At least [***] in advance of the first meeting of the JSC in each calendar year, Arctic Vision shall provide Clearside with a written update of the Development Plan, including any amendments thereof.
Development Plan Updates. (a) Subject to the control and good faith consideration rights with respect to clinical studies as described in Section 4.08, updates to the Development Plan will be prepared by the Parties under the guidance of the JCD/RS, and the JOC will be responsible for approving such updates on at least an annual basis until the completion of the Development activities covered by the Development Plan.
Development Plan Updates. In the course of the performance of the Development Program, the Project Team will update the applicable Development Plan as it deems necessary and appropriate. In addition, the Project Team will update the budget for Development Expenses set forth in the applicable Development Plan in order to reflect the changes to the Development Plan. Any changes to a Development Plan, including changes to the budget for Development Expenses, are subject to approval by the Steering Committee.
Development Plan Updates. The JDC shall review the Development Plan [****] for the purpose of considering appropriate amendments thereto, including revisions to existing Development activities and the addition of new Development activities. In addition, either Party, through its representatives on the JDC, may propose amendments to the Development Plan at any time. Any proposed amendment to the Development Plan shall be reviewed by the JDC. Any amendment to the Development Plan will not be binding on either Party until approved by the JDC [****] and upon such approval by the JDC [****], the updated Development Plan shall be deemed to be incorporated into this Agreement. With respect to any amendment to the Development Plan to add new Development activities (including any Development activities that are required to be conducted by a Regulatory Authority to support Regulatory Approval of a Licensed Product in a given jurisdiction) or modify any Development activities in a manner that would change the cost of such activities, such amendment shall include a corresponding amendment to the Budget for the Development Plan; [****].
