Examples of Core Development Plan in a sentence
The Core Development Plan will be updated by VERTEX annually thereafter to describe the Core Development Activities that VERTEX then intends will be conducted during the subsequent year and the remainder of the development period.
Such Core Development Plan will be provided to the JDC within [***] days of the date that the JDC will conduct one of its quarterly or semi-annual meetings.
Each Party shall prepare and deliver to the other Party a [***] report detailing its Development Costs incurred during such period with respect to activities covered by the Core Development Plan.
UGNX shall keep KHK reasonably informed of its anticipated requirements of the Licensed Products for Core Development Activities and Non-Core Development Activities through the JDC and the Core Development Plan and Non-Core Development Plan by providing a good faith estimate of such requirements on a [***] basis, the first [***] months of which shall be binding, to be updated [***], (collectively, the “UGNX Forecast”).
The Core Development Plan will be considered Confidential Information of VERTEX subject to the confidentiality obligations of Article IX.
The JDC shall have the right to review and comment on the Core Development Plan within [***] days of its receipt.
Without limiting the generality of the foregoing, neither the JSC nor any subcommittee will have any power to amend, modify or waive compliance with this Agreement (without limiting the right of the JSC to approve amendments to the Core Development Plan) and the JSC and subcommittees are otherwise subject to the express terms and conditions of this Agreement.
Within a reasonable period of time after the Effective Date and in accordance with the Core Development Plan, KHK shall provide to UGNX (a) the data (tables, listings and figures) and final report on completed Clinical Trial, (b) the interim data (tables, listings and figures) on Phase 1/2 extension study (KRN23-INT-002), and (c) the final reports on completed non-clinical studies related to the Licensed Products.
Upon mutual written agreement by the Parties to Develop such indication(s), the JDC shall update the Core Development Plan to include such indication consistent with Section 4.2. Until the Profit Share Territory Transition Date, UGNX shall use Commercially Reasonable Efforts to Develop at least one additional indication mutually agreed-upon by the Parties pursuant to the foregoing sentence (each such indication, an “Additional Indication”) and shall complete any On-Going Clinical Trials.
All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3.