Development Plan Sample Clauses

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 Concession 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. (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...

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. Genentech shall use Commercially Reasonable and Diligent Efforts to create a Development Plan (which shall be attached as Exhibit E hereto) within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For avoidance of doubt, the Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the JSC in the written minutes of the applicable JSC meeting; anything not approved by the JSC in such written minutes shall be deemed to be excluded from the Development Plan.

Development Plan. Within thirty (30) days after the Effective Date, Anji Pharma shall prepare an initial Development plan, setting forth the non-clinical and clinical Development activities with respect to the Product pursuant to this Agreement, and deliver such Development plan to LipimetiX. The Parties shall promptly discuss and endeavor to finalize such initial Development plan within thirty (30) days thereafter, which upon mutual acceptance by the Parties, shall be deemed effective (the “Initial Development Plan”). During the Term, except as may be expressly set forth in this Agreement and the Development Plan agreed to by the Parties, the Anji Pharma Related Parties shall have sole authority over, and control of, the Development of Compounds and Products in the Territory, including the Manufacture of Compounds and Products for such Development, and shall bear all costs and expenses of such Development. Prior to January 1 of each calendar year during the Term, an Anji Pharma Related Party shall prepare an updated Development Plan for the following calendar year and submit such revised Development Plan to LipimetiX. Anji Pharma may from time to time, at its election and sole discretion, revise the Development Plan between annual updates; provided, however, that Anji Pharma will provide to LipimetiX such revised Development Plan in the event of any material changes to the Development Plan along with an explanation of the reasons for any such material changes. Notwithstanding the foregoing, (a) any modification to the Development Plan that materially increases the costs or obligations of LipimetiX shall require the prior written approval of LipimetiX, (b) the Development Plan shall summarize the Development activities of the Anji Pharma Related Parties in sufficient detail to enable LipimetiX to determine Anji Pharma’s compliance with its diligence obligations hereunder, and (c) the Development Plan shall always include (i) a program of Development activities and (ii) reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development for the Compounds and Products. Any revised Development Plan shall be deemed to be agreed to upon submission to LipimetiX or, if subject to LipimetiX’s approval rights in the immediately preceding sentence, upon written approval of LipimetiX. If LipimetiX believes that a change to the Development Plan would be reasonably expected to have a material adverse effect on Development or Commercialization activities for t...

Development Plan. The term “