Initial Development Plan Clause Samples
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Initial Development Plan. The Parties have agreed upon an Initial Development Plan setting forth the design, costs, protocols, roles and responsibilities, and timelines of the Development activities to be undertaken with the objective of obtaining Regulatory Approval for the Product in the Development Indication by the FDA, Health Canada and EMA, as further set forth in this Section 5.1. The clinical and regulatory strategy contemplated by the agreed Initial Development Plan will be submitted to the FDA in advance of the FDA Development Meeting, which meeting will be held as soon as practicable after the Effective Date but in any event the Parties shall endeavor to schedule such FDA Development Meeting to occur within [*] Calendar Months after the Effective Date. Following the FDA Development Meeting:
(a) If no material changes or alterations of the Initial Development Plan (including the JDC-Approved Development Budget) are required, then it shall be deemed a JSC approved Development Plan, and, subject to the satisfaction of the conditions set out in Section 2.2, the Parties shall commence Development of the Product in the Development Indication in the Development Territory in accordance with such Development Plan as soon as practicable thereafter;
(b) If either Party believes that any decision, recommendation or other feedback from the FDA requires amendment of the Initial Development Plan, the JDT shall promptly meet and decide how to implement such amendment. Except as otherwise set forth in Section 5.1(c), if the JDC approves such proposed amendment by the JDT, then the Initial Development Plan (including the JDC-Approved Development Budget contained in such Development Plan, which shall be amended accordingly in a manner that minimizes any increase in such JDC-Approved Development Budget whilst still giving effect to such JDC approved amendment) shall be amended accordingly and shall, subject to JSC approval, be deemed to be the Development Plan and the new JDC-Approved Development Budget, and, subject to the satisfaction of the conditions set out in Section 2.2, the Parties shall commence Development of the Product in the Development Indication in the Development Territory in accordance with such Development Plan as soon as practicable thereafter;
(c) If any amendment to the Initial Development Plan (including the JDC-Approved Development Budget therein) required to address such FDA feedback will (i) significantly increase the costs of Development, and/or (ii) extend the pro...
Initial Development Plan. Not later than [**] days following the Effective Date, Licensee shall provide Merck with the initial Development plan for the Licensed Product in the Field in the Territory (the “Development Plan”).
Initial Development Plan. The initial Development Plan has been prepared and approved by the Parties and reflects the Development activities of Licensee anticipated at the Effective Date in order to establish proof of concept of the Product in the Initial Two Indications. Licensee agrees to update the Development Plan, as set forth below, to reflect all additional Development activities (with corresponding timelines) to be undertaken by Licensee in connection with the Development of the Product.
Initial Development Plan. Licensee shall carry out all development activities with respect to the Licensed Product in the Territory in accordance with a development plan as agreed upon in writing by the Parties (the “Development Plan”).
Initial Development Plan. The Development Plan previously provided by Producer to Service Provider and identified as the initial Development Plan and attached as Exhibit B.
Initial Development Plan. The Development Plan provided by Producer to Gatherer and identified as the initial Development Plan.
Initial Development Plan. The initial Development Plan, along with the associated Development Budget, describing (among other things) the planned development of the Product for the CKD Indications for the U.S., is attached hereto as Exhibit H (the “Initial Development Plan”). The Initial Development Plan includes and shall be integrated with those Phase 3 Clinical Trials that are currently being conducted by FibroGen or Astellas under the U.S. and EU plan for conducting Phase 3 Clinical Trials of the Product for the CKD Indications under the Astellas EU Agreement (the “Transatlantic Clinical Development Plan” or the “TCDP”). FibroGen shall notify AstraZeneca, via the JDC, of all material updates and material changes to the TCDP. The Initial Development Plan shall further outline such additional Phase 3 Clinical Trials as the Parties have agreed to conduct (i.e. in addition to those being conducted under the TCDP). Within thirty (30) days after the Effective Date, the JPT will initiate implementation of the Initial Development Plan.
Initial Development Plan. A draft of the initial Development Plan, together with associated initial Development Budget, for TRU-016 is attached hereto as Exhibit B (the “Initial Development Plan”). The Parties shall make good faith efforts to agree upon the definitive Initial Development Plan and have it appropriately approved by the JSC within [ * ] after the Signing Date.
Initial Development Plan. The Development Plan attached hereto as Exhibit D. Interruptible Production. Production that is accorded the lowest priority on the Gathering System with respect to capacity allocations, interruptions, or curtailments. Interruptible Production will be the first Production removed from the Gathering System in the event of an interruption or curtailment. Liquids Gathering Fee. As defined in Section 5.1(a)(iv).
Initial Development Plan. The initial Development Plan for the Product shall be prepared by the Parties following the Parties’ consultation with the applicable Regulatory Authorities in the EU pursuant to Section 5.2.1(b). To the extent that future “national meetings” with the Regulatory Authorities in a specific country or territory within the Territory provide guidance with respect to the risk management plan or Development Activities in such country or territory, the Parties shall consider such guidance in updating and amending the Development Plan pursuant to Section 4.3.3.