Development Plan and Activities Clause Samples
Development Plan and Activities. (a) The JDC (defined below) shall oversee a development plan (as such plan may be amended from time to time by the JDC) pertaining to the development of the Existing Licensed Product for the First Indication, a copy of which, in initial form, together with the associated budgets and timelines is attached hereto as Exhibit D and incorporated herein (the “First Indication Development Plan”). Otsuka shall not be entitled to use its deciding vote on JDC or JCC so as to derogate from the right of GW Pharma to manage and conduct the development activities under the First Indication Development Plan. Following the Closing Date, the Parties shall prepare a development plan for the Second Indication, which shall be presented for consideration and approval by the JDC (the “Second Indication Development Plan”). Under the Second Indication Development Plan and other future development plans for Additional Indications activities will primarily be managed and conducted by Otsuka at its own cost and expense save that GW Pharma shall be responsible for the generation of all relevant CMC Data at its own cost and expense. The Parties acknowledge their respective regulatory responsibilities set forth in Article 8 and elsewhere herein, and agree otherwise to work together to develop the Existing Licensed Product for the First Indication in accordance with the Development Plan and for the Second Indication in accordance with the Second Indication Development Plan. The First Indication Development Plan sets forth, and the Second Indication Development Plan and other Development Plans will set forth, the activities to be undertaken in connection therewith by each of the Parties including pre-clinical and clinical activities, as well as the budgets and timelines therefor. All activities carried out in relation to any Development Plan (other than generation of the CMC Data) will be financed by Otsuka including all activities to be managed and conducted by GW Pharma in accordance with such Development Plan. No development activities shall be carried out by either Party in relation to a Licensed Product in the Territory under this Agreement save under a Development Plan approved and governed by JDC.
(b) GW Pharma shall, in consultation with Otsuka through the JDC and/or the JCC, design and prepare a plan for Phase II Clinical Studies and Phase III Clinical Studies along with any other pre-approval studies required as a condition for Full Regulatory Approval for the Licensed Product ...
Development Plan and Activities. The Parties will jointly be responsible for all Development activities with respect to the Licensed Compounds and Licensed Products (as further described below) for the Territory, and such activities will be conducted in accordance with the Global Development Plan/Budget (as defined below).
Development Plan and Activities. At all times during the Term prior to the Option Effective Date, Licensor shall conduct its Development efforts under a development plan (as may be amended pursuant to this Agreement from time to time, the “Development Plan”), which shall contain, at a minimum, all activities reasonably necessary to generate the Option Exercise Data Package and a reasonably itemized budget for such activities, including (a) all activities reasonably necessary to complete the Phase II SLE Clinical Study, (b) all non-clinical toxicology activities of the Licensed Compound reasonably necessary to conduct the other activities set forth in the Development Plan and (c) all CMC activities reasonably necessary to result in the Successful Completion of the [†] (subject to Section 1.95 (“Late Phase Development Activities”), such activities, along with any other activities under the Development Plan, the “Development Activities”). Notwithstanding the foregoing, the performance of the Late Phase Development Activities shall only be initiated, conducted and completed by Licensor upon request by AbbVie, in its sole discretion. The Parties have agreed upon an initial version of such Development Plan (and topline budget), which is set forth as of the Effective Date on Schedule 2.1.1 (Initial Development Plan) (such initial Development Plan, the “Initial Development Plan”). Licensor shall (i) perform all activities set forth in the Development Plan and any updated or amended versions thereof (except to the extent any such activity relies on the success or other outcome of a prior activity and such prior activity was not successful or did not achieve such outcome) and (ii) use Commercially Reasonable Efforts to (A) achieve the objectives set forth in the Development Plan and (B) achieve such objectives set forth in the Development Plan on the applicable timelines set forth therein, in each case ((A)-(B)), at Licensor’s sole cost and expense, subject to Section 2.1.4 (Budget Increases) and at all times in accordance with the terms of this Agreement and the Development Plan; provided that, with respect to cost allocation, [†]. The JGC shall review the Development Plan [†] for the purpose of review and comment in order to evaluate whether any amendments to the Development Plan should be approved; provided that the JGC shall also review the Development Plan to evaluate whether any amendments to the Development Plan should be approved promptly following receipt of key datasets from the Developme...
Development Plan and Activities. The JGC shall discuss any such proposed amendment in good faith, and each Party shall ensure that its JGC representatives reasonably consider any concerns and opinions of the other Party’s JGC representatives in good faith when deciding whether to approve such proposed amendment to the Development Plan. If the JGC cannot, or does not, reach consensus on such amendment, such dispute shall be subject to the dispute resolution provisions set forth in Section 3.1.5 (Dispute Resolution). Without limiting any other provision in this Agreement, including this Section 2.1.2 (Amendments to Development Plan) and Section 3.1 (Joint Governance Committee), if the FDA requests that Licensor amend, or Licensor reasonably determines as a result of feedback provided by the FDA that it is necessary to amend, the clinical portion of the Development Plan, then Licensor shall promptly notify AbbVie of the need for such amendment, keep AbbVie reasonably informed during the period when Licensor is making such amendment and, for the avoidance of doubt, Licensor shall consider any comments of AbbVie to such amendment in good faith.
Development Plan and Activities