Development Plan Clause Examples

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 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. The term “

Development Plan. (a) The Development Plan shall include the scientific, experimental, process development, non-clinical, clinical and regulatory activities, goals and timelines for the development of the Licensed Product for the coming Year in the Territory (in the case of PHARMAENGINE) and the Retained Territory (in the case of HERMES). The Development Plan shall be updated annually and be finalized only after review by JDC. The Development Plan in all other provisions under this Agreement shall mean the finalized Development Plan reviewed by JDC. The annual Development Plan of each of the Parties shall be submitted to JDC for discussion and review prior to [**] in each Year (the deadline for submitting the initial Development Plan may be determined by JDC if necessary). (b) Under the auspices of each of the Parties, the Parties shall have the following responsibilities: (1) Each of the Parties shall be responsible for the preparation of all protocols and the conduct of all activities for which such Party is designated as the Party responsible for such activities in the Development Plan or the determination of JDC; (2) PHARMAENGINE shall be responsible for preparing all necessary applications for regulatory approval of the Licensed Products in the countries in the Territory for which PHARMAENGINE is designated as the Party responsible for such preparation in the Development Plan or the determination of JDC, and PHARMAENGINE shall also be responsible to conduct all communications with the regulatory authorities in the Territory during the registration process. HERMES shall be responsible for preparing all necessary applications for regulatory approval of the Licensed Products in the Retained Territory for which HERMES is designated as the Party responsible for such preparation in the Development Plan or the determination of JDC, and HERMES shall also be responsible to conduct all communications with the Regulatory Authorities in the Retained Territory during the registration process; and (3) Each of the Parties shall provide all technical data and support necessary to assist the responsible Party to prepare such applications. (c) PHARMAENGINE shall use its best efforts to implement the development of the Licensed Product in the Territory in accordance with the timeline(s) approved by JDC or set forth in the Development Plan and in accordance with the terms of this Agreement. PHARMAENGINE shall further require its Sub-licensee in the Territory to use its best efforts to dev...

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. Those drawings identified on the attached Exhibit A prepared by ▇▇▇▇▇▇ Associates, Inc., together with all details and notes shown thereon, and all specifications referred to therein (including all amendments and revisions to date as well as any amendments and revisions lawfully adopted hereafter) are incorporated into this agreement by reference and are sometimes collectively referred to hereafter as the “Development Plan(s)”. With respect to the Development Plan, the Developer agrees upon request of the Town to furnish any supplemental information in connection therewith. Within ninety (90) days of the completion of the construction of each underground facility and testing thereof to the Town’s satisfaction the Developer shall deliver “as built” drawings with respect thereto to the Town. If not delivered within ninety days the Developer shall pay to the Town a penalty of $100.00 per day for each day beyond said period that the drawings are not delivered, the total amount of the penalty to be a charge against the bond required by paragraph 5 and failure to pay said penalty within thirty (30) days of the date when the drawings are delivered shall constitute an act of default entitling the Town to exercise the remedies set forth in paragraph 11. In the event of any conflict or inconsistency between one part of the Development Plan and any other part of the Development Plan or between said Development Plan and any specifications, standard details, development guidelines of the Town of Mount Airy, the subdivision regulations, landscape manual and ordinances of the Town of Mount Airy, or between any of them and this Agreement, then, in that event, such conflict or inconsistency shall be interpreted in the light most favorable to the Town and in the event of any dispute between the parties concerning such interpretations then the determination with respect to such dispute shall be made by the Town Engineer whose decision shall be final and conclusive upon the parties. Developer shall be bound by all of the applicable provisions of the zoning and subdivision regulations and all ordinances of the Town whether or not mentioned herein.

Development Plan. (i) The Development of the CD38 Product under this Agreement shall be conducted pursuant to a development plan to be implemented by or on behalf of I-Mab or its Affiliates or sublicensees to obtain Regulatory Approval of the CD38 Product in the Field in the Territory (the “Development Plan”). The Development Plan shall be consistent with I-Mab’s obligation under the MorphoSys License with respect to the Development of the CD38 Product. The Development Plan shall also include a detailed budget (the “Development Budget”) for such Development activities. As of the Effective Date, the Parties have agreed on the initial Development Plan, attached hereto as Exhibit B. Pursuant to the initial Development Plan, the Development of CD38 Product shall be [completed] by December 31, 2024 (“Development Complete Date”) with a total budget of US$200,000,000 (the “Initial Development Budget”). Such Initial Development Budget shall be inclusive of all costs and expenses to be incurred by or on account of I-Mab and Everest under the initial Development Plan, but shall not include and shall be in addition to any payments (including upfront payments, development milestone payments, and any other payments) made by I-Mab under the License and Collaboration Agreement by and between I-Mab and MorphoSys AG (“Morphosys”), dated November 30, 2017 (the “Morphosys Agreement”). (ii) From time to time, I-Mab shall prepare amendments and updates to the then-current Development Plan and Development Budget and submit such amendments and updates to the JSC for review and approval. Once approved by the JSC, such revised Development Plan and Development Budget shall replace or supplement, as appropriate, the prior Development Plan and Development Budget. (iii) Upon the Listing of I-Mab, if I-Mab proposes to increase the Initial Development Budget or the then applicable Development Budget (as determined in accordance with this Article 3.2(a)(ii) and/or (iii)) (such amendment, “Material Development Plan Amendment” and such incremental increase of the Initial Development Budget, the “Increased Amount”), in addition to the approval by the JSC as required under Article 3.2(a)(ii), I-Mab shall comply with the applicable rules of the stock exchange on which its securities are listed (“Applicable Listing Rules”) and submit such Material Development Plan Amendment for the approval of its shareholders who are not otherwise connected with Everest (to be determined by the Applicable Listing Rules) (the “...

Development Plan. (a) The initial Development plan for the Development of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the “Development Plan”). The Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activities; and (f) FTE estimates. (b) On no less than an annual basis, the JSC shall review the Development Plan and recommend any amendments or changes to the Development Plan and approve any such amendments or changes. (c) The Development of Products shall be conducted by Parties pursuant to good clinical practices (“GCP”) and good laboratory practices (“GLP”). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that t...

Development Plan. (1) Production of petroleum shall not commence until a Development Plan for the effective exploitation of the Unit Reservoirs, which has been submitted by the Unit Operator and contains a programme and plans agreed in accordance with Joint Venturers’ Agreements, has been approved by the Regulatory Authorities. The Unit Operator shall submit copies of the Development Plan to the Regulatory Authorities for approval. (2) The Commission may review, and make recommendations to the Regulatory Authorities with regard to, a Development Plan. (3) The Regulatory Authorities shall approve the Development Plan where: (a) the project is commercially viable; (b) the contractor or licensee possesses the competence and resources needed to exploit the reservoir to the best commercial advantage; (c) the contractor or licensee is seeking to exploit the reservoir to the best commercial advantage consistent with good oilfield practice; (d) the contractor or licensee could reasonably be expected to carry out the exploitation of the reservoir during the specified period; (e) the contractor or licensee has entered into contracts for the sale of gas from the project which are consistent with arm’s length transactions. (4) The Regulatory Authorities shall specify their reasons for not approving a Development Plan including identification of the criteria in paragraph (2) that the contractor or licensee has failed to meet. (5) The Regulatory Authorities shall ensure that the exploitation of the Unit Area shall be in accordance with the Development Plan. (6) The Unit Operator may at any time submit, and if at any time the Regulatory Authorities so decide may be required to submit, proposals to bring up to date or otherwise amend the Development Plan. All amendments or additions to the Development Plan require the prior approval of the Regulatory Authorities. (7) Where the Unit Operator has been notified by either Regulatory Authority that the Development Plan or an amendment to the Development Plan has not been approved, the Regulatory Authorities shall consult with each other and with the Unit Operator with a view to reaching agreement. (8) The Regulatory Authorities shall require the Sunrise Joint Venturers not to change the status or function of any Unit Installation in the Unit Area in any way except in accordance with an amendment to the Development Plan in accordance with paragraph (2). (9) Where a Sunrise Joint Venturer has entered into contracts for the sale of gas from the pr...