Long-Term Development Plan definition
Examples of Long-Term Development Plan in a sentence
Once any Decision Points and Success Criteria have been approved for a given indication as provided above, they shall not be subject to change or supplementation except as the Parties may mutually agree in the Long-Term Development Plan through Joint Committee Consent of the JEC or otherwise by mutual Party Written Consent.
Any and all Decision Points and Success Criteria for any Additional Indications and Additional Formulations shall be set forth in an amendment to the then existing Long-Term Development Plan for the applicable Product.
Subject to the terms of this Agreement, the JJDC shall be charged with taking any action and making any decision necessary to implement the binding portion of the Long-Term Development Plan and each approved strategy in cooperation with the Existing Committees, the JJCC, JJFC, and the JJMC, as applicable.
If the actual total Development Costs for a Clinical Trial (over the life of such trial) provided for in the Long-Term Development Plan (as amended in accordance with Section 3.2(c)) exceed those set forth in the budget for such [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.
Since then, Croatia has adopted two strategic documents which identify the situation in the defence sector, point out to desirable reforms and map the new vision of the Armed Forces – the Strategic Defence Review and the Long-Term Development Plan.
The Long-Term Development Plan and the Parties’ efforts to Develop the Collaboration Compounds are intended to focus initially on the Initial Product.
It is contemplated that each Long-Term Development Plan will include, among other things, all matters of strategic importance related to the Development of the applicable Collaboration Compound and Product for all indications included in the Collaboration and other material clinical and regulatory matters.
The Long-Term Development Plan for the Initial Product as of the Execution Date is attached hereto as Exhibit H.
The SCJ shall determine and approve the strategic development related process flows and Clinical Trial instructions, including those relating to bulk drug substance and Final Product supply shipment, handling, testing, data query generation, resolution and Master Database (defined in Section 3.6(a) below) for each Clinical Trial required to be conducted under the Long-Term Development Plan or Annual Development Plan and Budget.
The SCJ may amend or supplement the Long-Term Development Plan, and make any decision necessary to fulfill the Long-Term Development Plan in accordance with this Agreement.