Initial Development Plan means the initial development plan prepared by representatives of Symphony Dynamo and Dynavax prior to the Closing Date, and attached to the Amended and Restated Research and Development Agreement as Annex C thereto.
Initial Development Plan means the initial Development Plan (including the Development budget) attached hereto as Schedule 1.33 covering the initial Development activities, as the same may be amended from time to time in accordance with the terms hereof.
Initial Development Plan means, with respect to any Program, a plan that describes the plan for conducting Development with respect to each Drug Candidate, including by specifying clinical and nonclinical studies and activities to be conducted and anticipated Development activities for each Drug Candidate (including the following anticipated activities or events: a description of the indication targeted, timelines, phasing of Development, study treatments, major inclusion and exclusion criteria, primary endpoints, study size, timelines for data preparation and filing of regulatory submissions, toxicology and a plan for selecting appropriate species for toxicology studies, ADME, and pharmacology studies and manufacturing process development). The Initial Development Plan will include drug design and Development activities that are in keeping with the Parties’ current drug design and Development practices and that are reasonably calculated to result in the Development of the Drug Candidates that may be progressed through to Commercialization. The Initial Development Plan as of the Effective Date is set forth on Exhibit 1.68, which may be amended from time to time in accordance with Section 3.2.5.
Examples of Initial Development Plan in a sentence
The first Master Plan for the Airport must be consistent with the Initial Development Plan and must incorporate the Mandatory Capital Projects.
During the implementation of Stage 1 and Stage 2 of the Initial Development Plan, as subsequently reflected in the Master Plan, the JVC will seek to achieve steady improvements in performance over time.
Any significant deviations from the Initial Development Plan must be fully explained.
The Initial Development Plan shall serve as the Development Plan for the first full Calendar Year of this Agreement and the period from the Effective Date through the end of the initial partial Calendar Year.
After the Effective Date, as between the Parties, except as set forth in the Initial Development Plan (as the same may be amended in accordance with Section 3.1.2) and Section 3.8.1, Adapt shall be solely responsible for Development of the Products.
More definitions of Initial Development Plan
Initial Development Plan means the initial development plan for the Product, as outlined in Schedule 2 attached hereto.
Initial Development Plan means the plan (including timeline and budget) covering preliminary Development activities to be completed by Ultragenyx and Takeda (to the extent expressly provided in such plan) for a Licensed [***] Product in the Licensed Field attached
Initial Development Plan means the Development Plan agreed by the Parties for the purposes of the FDA Development Meeting, a draft of which is attached to this Agreement as Schedule 8 as it exists at the Effective Date.
Initial Development Plan means the initial version of the Development Plan, which shall include at least (i) the study outline for each of the Initial Studies, (ii) plans for the performance of the Initial Studies, including timelines, (iii) a description of the activities related to the clinical pharmacology, toxicology and Chemistry, Manufacturing and Control (CMC) that are critical to support clinical plans for each of the ESRD Study and the CKD Study, and which shall be prepared and provided pursuant to Section 4.2. An outline of the material items to be described in the Initial Development Plan is attached hereto as Exhibit A.
Initial Development Plan means: (i) the initial Development Plan for the initial Licensed Product having a Monovalent Ad26 ZEBOV Vector and a Multivalent MVA-BN Vector; and/or (ii) the initial Development Plan for the initial Licensed Product having a Multivalent Ad26 Vector and a Multivalent MVA-BN Vector; each as described in Section 4.2 attached as Annex F and “Initial Development Plans” shall means each aforementioned Initial Development Plan collectively.