Examples of Initial Global Development Plan in a sentence
The Parties acknowledge that the Initial Global Development Plan is preliminary and provides high-level Work Plans for initial Development activities.
The Initial Global Development Plan as of the Effective Date (attached hereto as Exhibit C) includes: (a) the Work Plan for the Initial Study; (b) the Work Plan for each Ongoing Study that will continue (if any); (c) the Work Plan for each Ongoing Study that will be wound down; and (d) the Work Plan for any other clinical study of Licensed Products.
Each Party will conduct, and ensure that each of its Affiliates and Third Parties engaged by such Party conducts, all of its and their activities with respect to the development, registration, manufacture, distribution, promotion and Commercialization of the Product in accordance with this Agreement, the Initial Global Development Plan, the Global Development Plan, the Global Pricing Policy, the Quality and Compliance Standards, Proper Conduct Practices, and all Applicable Law.
The initial global development plan and corresponding budget for the Licensed Compounds and Licensed Products is set forth on Schedule 5.2 (Initial Global Development Plan and Budget) (such global development plan attached as of signing, the “Initial Global Development Plan” and as it may be modified in accordance with the terms and conditions of this Agreement, the “Global Development Plan” and such corresponding budget, the “Global Development Budget”).
The initial Global Development Budget is attached hereto in Schedule 4.4.1 (Initial Global Development Plan and Initial Global Development Budget).
As promptly as possible following the Execution Date, Novartis shall (a) sponsor, communicate with Regulatory Authorities, initiate, operationalize and conduct […***…] in accordance with the Initial Global Development Plan and under an IND prepared and filed by Novartis and (b) sponsor, initiate, operationalize and conduct […***…]; provided, that, […***…].
The Initial Global Development Plan, which is attached hereto as Exhibit A, includes a detailed Clinical Trial plan which describes (a) the Initial Global Studies being conducted by XxxXxxx, (b) the Novartis-Initiated Trials conducted by Novartis, and (c) all other Clinical Trials, including data-generation Clinical Trials, to be conducted by Novartis.
List of Exhibits: Exhibit A: Chemical Structure of cabozantinib Exhibit B: Exelixis Patents Exhibit C: Approved Distributors Exhibit D: Initial Global Development Plan and Budget Exhibit E: Press Release [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.
During the Term, the JDC shall review, discuss and approve potential amendments to the Initial Global Development Plan, at least […***…].
The initial Global Development Plan (including the initial Global Development Budget) is attached hereto as Schedule 4.4.1 (Initial Global Development Plan and Initial Global Development Budget).