Initial GDP definition
Examples of Initial GDP in a sentence
For clarity, the Clinical Studies included in the Initial GDP (as such Clinical Studies may be modified or amended in accordance with this Agreement following the Effective Date) are deemed to have been approved by the JDC for purposes of this Section 4.2.1. [***] pursuant to this Agreement without [***].
Unless otherwise agreed by the Parties, such comprehensive GDP shall be consistent with the Initial GDP.
Promptly following the Effective Date, the JDC will prepare and the JSC shall approve a comprehensive GDP that includes all Development activities that are reasonably necessary to support Marketing Approval and Commercialization of such Product for each indication in the Initial GDP in the U.S., ▇▇▇▇▇▇▇ Territory and Greater China.
For clarity, each Clinical Study described in the Initial GDP is a Clinical Study of the Initial Product for the Field.
The Initial GDP is attached hereto as Exhibit 1.44 (which also includes the complete initial Development Budget as described in Section 4.2.
The Initial GDP is attached hereto as Exhibit 1.58 (which also includes overall total budget figures for the initial Development Budget as described in Section 4.2.3, and budget forecasts for subsequent periods as described in Section 4.2.5(b)).
The budget amounts indicated in the Initial GDP will constitute the initial Development Budget.