Initial Development Plans. It is the intention of the Parties that those Development activities in Part A of the Initial Development Plan for the Licensed Product having the Monovalent Ad26 ZEBOV Vector and the Multivalent MVA-BN Vector and Part B of the Initial Development Plan for the Licensed Product having at least the Multivalent Ad26 Vector and the Multivalent MVA-BN Vector shall be funded in whole or in part by the United States National Institutes of Health (NIH) or other governmental or external bodies. In the event that such NIH funding and/or other governmental and/or external funding is not obtained, Crucell shall assume full responsibility for paying the budgeted costs as set forth in the Development Plan for those Development activities in Part A as well as those Development activities in Part B of the Initial Development Plan for the Licensed Product to the extent those activities are not covered by said United States National Institutes of Health (NIH) or other governmental or external bodies. Crucell anticipates that funding will be obtained from the United States government to support the activities contemplated by this Agreement, BN agrees to be bound by those FAR (Federal Acquisition Regulation) clauses that are incorporated into the agreements providing or resulting from any such US government funding arrangements. Those clauses will be incorporated herein with the same force and effect as imposed upon Crucell or its Affiliates due to the United States government funding arrangements.
Initial Development Plans. An initial development plan for the Compound and XenoPort Products is attached to this Agreement as Exhibit 4.1 ("XenoPort Product Development Plan") and sets forth the development activities to be conducted in the Territory and, to the extent permitted in accordance with Section 2.1, the development activities to be conducted outside the Territory for the Compound and XenoPort Products. Within [**] following the Effective Date, Xanodyne shall provide to XenoPort an initial development plan for the Xanodyne Product, which shall set forth the development activities to be conducted for the Xanodyne Product ("Xanodyne Product Development Plan"). Upon receipt by XenoPort, the Xanodyne Product Development Plan shall be deemed to be incorporated into this Agreement and, upon request by either party, Exhibit 4.1 shall be updated to include the initial Xanodyne Product Development Plan. For the purposes of this Agreement, the XenoPort Product Development Plan and the Xanodyne Product Development Plan shall be referred to collectively as the "Development Plan".
Initial Development Plans. For each Development Candidate under a Collaboration Program, within [***] days after designation of such Development Candidate, the applicable Neurology JDC will agree on an appropriate clinical development plan for such Development Candidate through completion of the first PoC Trial (each, an “Initial Development Plan”). With respect to each ALS Collaboration Program and each Biogen Conducted Non-ALS Collaboration Program, Biogen shall propose the initial draft of such Initial Development Plan to the Neurology JDC for review, comment and approval. With respect to each Collaboration Program that is not an ALS Collaboration Program or a Biogen Conducted Non-ALS Collaboration Program, Ionis shall propose the initial draft of such Initial Development Plan to the Neurology JDC for review, comment and approval. In each case, any such initial draft of an Initial Development Plan shall include the information set forth on Schedule 1.10.2(d). If the Neurology JDC cannot agree upon the Initial Development Plan for a particular Collaboration Program, the matter will be referred to the CSC for resolution. If the CSC cannot agree on the Initial Development Plan within [***] days after the matter is so referred, [***] will have final decision-making authority with respect to the contents of the Initial Development Plan. In addition, prior to the Initiation of the first Clinical Study under the Initial Development Plan for a Collaboration Program, the Parties will endeavor to mutually agree on a communication plan regarding the public disclosure of data and results arising from such Collaboration Program; provided, that if the Parties cannot agree on such a communication plan, then [***] will have final decision-making authority regarding any such communications occurring prior to the License Effective Date with respect to a Collaboration Program.
19 (i) The Party responsible for conducting the Clinical Studies under a Collaboration Program will file and maintain the IND and other communications with Regulatory Authorities for each Collaboration Program consistent with Section 5.2.1. Notwithstanding the foregoing, with respect to each Collaboration Program for which Biogen is responsible for conducting the Clinical Studies, including each ALS Collaboration Program and each Biogen Conducted Non-ALS Collaboration Program, Ionis shall provide such reports and/or data as reasonably requested by Biogen generated from Ionis’ activities performed under the applicable Initial ...
Initial Development Plans. The Initial Development Program shall be conducted pursuant to two (2) Initial Development Plans, one (1) for XEN901 and one (1) for the two (2) DTCs designated as Development Candidates. If the terms of an Initial Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. From time to time (and no less frequently than once per calendar quarter), as set forth in Section 3.1(j), the JSC shall review each of the Initial Development Plans and, as appropriate, and to the extent necessary, prepare and approve amendments thereto. Upon JSC approval of any amendment or modification to an Initial Development Plan, the JSC will attach such amended or modified Initial Development Plan to the minutes of the JSC meeting at which the same is approved and provide a copy of such minutes to each Party within [†] days.
Initial Development Plans. Attached. [***]
Initial Development Plans. The initial Development Plans for Plicera, Amigal and AT2220 are attached hereto as Appendix 4.
Initial Development Plans. On or before Closing, POCI shall submit to ------------------------- PGP and CEPI a plan for the development of the Antelope Creek Field from Closing to December 31, 1996 (the "Initial Plan"). On or before October 31, 1996, POCI shall submit to PGP and CEPI a plan for the development of the Antelope Creek Field from January 1, 1997, through such date as the parties will have jointly contributed Twenty Million Five Hundred Ninety-Three Thousand Dollars ($20,593,000) in project costs to the development of the Antelope Creek Field, as provided in section 1 above (the "Secondary Plan"). POCI shall consult with CEPI and PGP in formulating the Initial Plan and Secondary Plan. POCI shall, at least thirty (30) days before the end of each month, submit to PGP and CEPI an estimate of expenses to be incurred during the following month in carrying out the Initial Plan and the Secondary Plan. PGP and CEPI shall pay their respective shares of such expenses to POCI by the first day of the month in which the expenses are to be incurred.
Initial Development Plans. An Initial CNS Development Plan and CNS Development Budget, as well as an Initial Peripheral Development Plan are attached to this Agreement as Schedule 1.73, Schedule 1.74 and Schedule 1.75, respectively.
Initial Development Plans. Tango shall provide to Gilead, in each Opt-In Data Package other than where the Clinical POC Opt-In Point has been achieved for the applicable Target, a proposed development plan detailing the discovery or development efforts to be undertaken by Tango with respect to such Target until the next Opt-In Point if Gilead elects to Extend such Target. The JSC shall meet to discuss such development plan, including any modifications thereto requested by Gilead, prior to the expiration of the applicable Opt-In Period and, upon Extension of such Target by Gilead pursuant to Section 2.7 or Section 2.8.4 and approval of such development plan (as may be so modified) by the JSC, such development plan shall be deemed the initial Development Plan for such Extended Target.
Initial Development Plans
