Common use of Development Plan and Activities Clause in Contracts

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 for the First Indication in the Territory together with the preparation of all final study reports in support of the NDA in order to maximize market potential. Otsuka shall reasonably cooperate in such activities. (c) GW Pharma shall be the owner of the IND for the First Indication for the Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies and Phase IIIb Clinical Studies and any subsequent INDs covering Licensed Product for the Second Indication and Additional Indications, until such time as Otsuka has filed in its own name the NDA covering Licensed Product for the First Indication. Once Otsuka has filed the NDA covering Licensed Product for the First Indication, GW Pharma shall promptly transfer to Otsuka any IND, if held, covering Licensed Product for the Second Indication and Additional Indications and Otsuka shall assume responsibility for filing, in its own name, any subsequent INDs for the Second Indication or Additional Indications, as appropriate. Otsuka shall be the owner of the NDA and the subsequent FDA Regulatory Approval covering Licensed Product for the First Indication and for the NDA and subsequent FDA Regulatory Approval for the Second Indication and Additional Indications. Otsuka shall pay the maintenance fees for all FDA Regulatory Approvals and any DEA Regulatory Approvals irrespective of which party owns the same. Otsuka shall be responsible for the design and conduct of all clinical studies in support of the Second Indication and any Additional Indications. Regulatory affairs shall otherwise be governed by Article 8. (d) GW Pharma shall develop all CMC Data necessary for submission of an NDA for the Licensed Products for any indication, which for the First Indication and Second Indication shall be at the cost of GW Pharma and which for Additional Indications and other Licensed Products to be agreed by the JDC but no such proposal for GW Pharma to develop CMC Data for Additional Indications or such other Licensed Products shall obligate GW Pharma to incur the costs thereof without its consent.