Core Development Plan Clause Samples
Core Development Plan. 4.2.1 The Parties shall prepare in writing an overall Development plan and budget (as such plan and budget may be amended from time to time in accordance with this Agreement, the “Core Development Plan”) covering the entire Development period and the Development activities and costs required in order to obtain and maintain the Marketing Approvals and (if applicable) the Pricing and/or Reimbursement Approvals for the Licensed Products (including Phase 4 Clinical Trials, if applicable) for the First Indication in the Profit Share Territory and the European Territory (such activities, collectively, “Core Development Activities”). The Parties acknowledge and agree that it is their intent to seek Marketing Approval in the First Indication for a label that is as broad as reasonably possible (including, for clarity, broad use by age), taking into account, among other things, the requirements of Applicable Laws and the interest in making Licensed Products in the Field commercially available in a timely manner. In addition to Clinical Trial(s) designed to obtain Marketing Approval for pediatric patients from the age of five (5) through the age of eighteen (18), unless otherwise agreed upon in writing by the Parties, the Core Development Plan shall include a Clinical Trial for pediatric patients below the age of 5. For clarity, the Core Development Plan and Core Development Activities shall cover the 001 and 002 Studies. The initial Core Development Plan has been mutually agreed in writing by the Parties as of the date of signing this Agreement, and shall be the operative Core Development Plan until amended with the approval of the JSC.
4.2.2 With the exception of the 2013 and 2014 Budgets (each as defined below), each year by [***], the Parties shall prepare and approve a detailed annual plan and budget covering the portion of the Core Development Plan and Core Development Activities that will be performed during the [***] months of the following Calendar Year. The detailed annual plan and budget covering the portion of the Core Development Plan and Core Development Activities that will be performed for the period from the Effective Date until December 31, 2013 and that has been agreed upon by the Parties in writing as of the Effective Date (the “2013 Budget”). The detailed annual plan and budget covering the portion of the Core Development Plan and Core Development Activities that will be performed during Calendar Year 2014 (the “2014 Budget”) shall be prepared an...
Core Development Plan. As soon as practicable after the Effective Date, VERTEX will prepare a development plan for the conduct of the Core Development Activities (the “Core Development Plan”), including an accompanying budget, and will provide a copy of such Plan to the JDC. 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. 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. Within such [***] day period, the JDC shall also (i) confirm that the Core Development Activities described therein fall within the scope of such definition and (ii) agree upon the protocols for non-clinical studies, which agreement shall not be unreasonably withheld or delayed. In the event that the JDC cannot reach consensus with respect to a matter described in either clause (i) or (ii) above, such matter shall be referred to the Joint Steering Committee for resolution in accordance with the terms of Sections 10.2.1 and [***] Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Core Development Plan. The Parties have agreed on the initial Development plan for the Licensed Product in the Core Indications in the Field in the Territory (as may be amended in accordance with this Agreement, the “Core Development Plan”), a copy of which is attached hereto as Exhibit A.
Core Development Plan. UGNX will be the lead Party for all Development activities for the Licensed Product, except as otherwise provided in this Article 4. For any Licensed Product, the Development activities to obtain Marketing Approvals for such Licensed Product for the first adult Indication and the first pediatric Indication in the U.S. and the EEA respectively shall be set forth in a reasonably detailed development plan (as may updated as provided herein, the “Core Development Plan”), which shall include a description of the Development activities, expected timelines, clinical Development, non-commercial Manufacturing (including the CMO(s) used for clinical Manufacturing), process development and CMC to support manufacturing scale-up for commercial supply, regulatory activities including preparation and submission of Regulatory Filings, as well as product risk assessment for planned activities, all as necessary to enable creation of a Core Dossier. The Core Development Plan shall also include all on-going Clinical Trials conducted by or on behalf of Mereo for the Licensed Product existing as of the Effective Date (“Existing Studies”). UGNX shall be primarily responsible for the activities set forth in the Core Development Plan, provided that, (a) Mereo shall be responsible for conducting all Existing Studies, provided, however, that Mereo shall not make any material changes to such Existing Studies without UGNX’s prior written approval; (b) upon UGNX’s reasonable request and Mereo’s reasonable acceptance, Mereo will provide specific support for the site management, patient enrollment or other supportive activities for Clinical Trials set forth in the Core Development Plan (“Supportive Development Activities”). The Core Development Plan shall include a reasonably detailed description of the schedule of work activity and the allocation of responsibility therefor. As the circumstances may require, either Party may propose from time to time, through the JDC and the JSC, amendments to the Core Development Plan, subject to UGNX’s final decision-making authority pursuant to Section 3.1.9(c) following good faith discussion of the proposed amendment by the JDC and JSC pursuant to Section 3.1.5(a) and Section 3.1.3(b)(ii), respectively. To the extent permitted under applicable Laws, UGNX shall have the right to reference and use any data generated from Development activities under the Core Development Plan for Development and Commercialization of the Licensed Product in the UGNX Terr...