Initial Global Development Plan definition
Examples of Initial Global Development Plan in a sentence
All Clinical Trials that are included in the Initial Global Development Plan and/or the Additional Global Development Plan that are conducted by a Party during the Option Period shall be sponsored, initiated, operationalized and conducted under such Party’s IND.
The mutually agreed initial Global Development Plan for the Licensed Products (the “Initial Global Development Plan”) is attached hereto as Schedule 4.3.2 (Initial Global Development Plan).
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 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.
On and after […***…], the Parties may, subject to mutual written agreement, prepare amendments to the Initial Global Development Plan to include additional Clinical Trials as part of the Initial Global Development Plan.
In addition, each Party shall promptly make available to the other Party such information about its material activities under the Initial Global Development Plan and Co-Detail and Field Medical Liaison Plan as may be reasonably requested by the other Party.
The Work Plans and Development Budgets for the Ongoing Studies and Initial Studies as of the Effective Date are part of the CDP under the Initial Global Development Plan.
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 Parties have agreed either to wind-down and terminate each Ongoing Study or at ▇▇▇▇▇▇▇’▇ election to continue it, in each case as part of the Initial Global Development Plan as set forth on Exhibit K.
QLT and Novartis shall share in accordance with the Funding Formula all Development Expenses for the interim Development activities for the period from July 1, 1994 through to the commencement of the Initial Global Development Plan, expected to be no later than December 31, 1995.