Development Plan. The Parties’ respective responsibilities for the Development of the Collaboration Compounds and the Products are set forth in this Article 4. As of the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduc...
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.
Development Plan. The Parties will undertake the Development of the Licensed Product in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Licensed Product in the Territory under this Agreement will be governed by a written development plan (the “Development Plan”), as such Development Plan may be revised from time to time in accordance with this Section 5.2. The Development Plan will contain in reasonable detail the major Development activities and the timelines for achieving such activities. As of the Effective Date, the Parties have agreed to the initial Development Plan, which is attached hereto as Schedule 5.2 (the “Initial Development Plan”). From time to time, but at least every 12 months, Zai will propose updates or amendments, if any, to the Development Plan in consultation with Paratek and submit such proposed updated or amended plan to the JSC for review, discussion, and approval. In accordance with Section 3.2(b), the JSC will review and approve any updates or amendments to the Development Plan.
Development Plan. As defined in Section 3.2(a).
Development Plan. The term “
Development Plan. Within two (2) Years following the declaration of a Commercial Discovery, the Contractor shall submit to the CNH for its approval the corresponding Development Plan. The Development Plan shall: (i) cover the entire Development Area; (ii) include at a minimum the information required by Annex 8; (iii) foresee the use of adequate methods and processes to obtain the maximum ultimate recovery factor for the Reserves, complying with Industry Best Practices, as well as (iv) include the corresponding program for the efficient use of Natural Gas and the mechanism for the measurement of the production of Hydrocarbons. The CNH will grant or deny its approval of the proposed Development Plan in a period not to exceed one hundred twenty (120) Days following its receipt of the necessary information pursuant to the terms of the Applicable Laws. In the event the CNH does not issue a decision during the provided term, it will be deemed to have made a favorable decision.
Development Plan. The Initial Development Plan shall be provided by Licensee to Mount Sinai within thirty (30) days of the Effective Date and become a part of this Agreement upon the written consent of the Parties. With respect to each Calendar Year following the Effective Date, Licensee shall deliver to Mount Sinai an annual updated Development Plan in accordance with Section 6.5, which shall set forth in reasonable detail the planned Development activities for such Calendar Year and the subsequent Calendar Year, as well as the anticipated timeline and budget for such activities. Such updated Development Plan shall replace the prior Development Plan and become incorporated into and a part of this Agreement only upon written approval of Mount Sinai of such updated Development Plan. Licensee has not fulfilled its obligations under this Section 3.1 until such approval of Mount Sinai of such updated Development Plan is provided. Licensee will promptly provide additional information as reasonably requested by Mount Sinai.
Development Plan. Development shall be limited to the authorized area and improvements specified in the approved development plan or subsequent modifications approved by the AO. The Lessee is responsible for accurately siting development and operations within the authorized area. Any proposed revisions to the development plan must be approved in writing by the AO before the change in use or development occurs.
Development Plan. During the Term, Developer agrees that it shall perform and comply with each and all of the terms and provisions of the Development Plan and not suffer or permit any default or breach of any such terms or provisions of the Development Plan.
Development Plan. The Development of the Licensed Product(s) in the ZAI Territory shall be conducted by ZAI pursuant to a Development plan that will include a description of the Development activities to be performed in support of the Regulatory Approval of the Licensed Product(s) in the ZAI Territory, including projected timelines for completion of such activities (the “Development Plan”). The initial Development Plan agreed to by the Parties is attached hereto as Exhibit D. Any material changes to the Development Plan shall be drafted by ZAI and shared with TESARO, including the addition of any clinical trial protocols or any material changes thereto, and shall require the approval of TESARO (such approval not to be unreasonably withheld). In the event of any proposed change to the Development Plan as a result of any interaction with any Regulatory Authority, the JSC shall meet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Development Plan.