Development Plans Sample Clauses

Development Plans. The term “Development Plans” as used herein means the Site Plan, Preliminary Plat, Final Plat, Construction Plans, Subdivision Hardscape and Landscape Plans, Amenity Plans, Lot Grading Plans, and Lot Utility Layout, in the forms approved by Buyer and Seller in accordance with this Agreement and approved by the applicable Governmental Authorities. All Development Plans for the Sections shall be prepared in accordance with the development specifications attached hereto as Exhibit B-1 (the “Development Scope and Specifications”) and all Governmental Requirements. Seller shall be responsible for all costs and expenses related to the preparation and submission of the Development Plans. The “Development Plans” shall include all obligations and requirements applicable to the Section contained within any instrument disclosed by the Title Commitment or Survey.

Development Plans. The plat shall be developed in accordance with the following plans. The plans shall not be attached to this contract. If the plans vary from the written terms of this contract, the written terms shall control. The plans are: Plan A - Plat Plan B - Final Grading, Drainage and Erosion Control Plan Plan C - Tree Preservation and Reforestation Plan Plan D - Plans and Specifications for Public Improvements Plan E - Street Lighting Plan Plan F - Landscape Plan Plan G - Permanent Traffic Control Plan

Development Plans. For the First Licensed Compound, the initial Development Plans through and including one Phase 2a Clinical Trial with respect thereto are attached hereto as Exhibit C and Exhibit D (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith estimates of Development activities and the timing, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the further Development of the relevant First Licensed Compound or following the approval for advancement into Development of any subsequent Licensed Compound, SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The Development Plan shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) key objectives, (b) Development and related Manufacturing activities to be performed with respect to a Licensed Compound, including Initiation of Clinical Trials, (c) the Party responsible for performance of an activity, (d) the number and types of FTEs to be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred under the Development Plans (the “Budget”) for the applicable twelve (12) month period, and (f) Development timelines. For the sake of clarity, neither the initial Development Plans attached hereto, nor any subsequent Development Plan once agreed by the Parties, may be amended except by mutual agreement of the Parties.

Development Plans. 253. A nurse may be placed on a developmental plan when there is a demonstrated, documented departure from standards of competence, which include the skills, knowledge and behaviors specific to the performance criteria. The developmental plan shall be proposed not more than eight (8) weeks after either the Performance Appraisal or the documented incident(s) indicating such departure. The developmental plan shall include specific, measurable goals with a specific time lines of not more than three months to completion. A plan may be extended by agreement, in writing, executed by the nurse, the Union and the supervisor. For implementing a developmental plan, shift assignments for a given nurse may be changed without regard to seniority for up to three months. The Department shall not arbitrarily or capriciously change the shift assignment of nurse pursuant to a developmental plan. If a nurse’s shift is changed, the nurse shall continue to receive any applicable home shift differential for the duration of the Developmental Plan. The decision requiring a developmental plan arising out of a written performance evaluation may be appealed to the appropriate Associate Administrator. The nurse may have, on request, a representative of choice at the appeal, which will be held no later than five (5) days before implementing the plan. The decision requiring a developmental plan shall not be subject to the grievance procedure.

Development Plans. During the Term, Licensee will conduct all Development activities in connection with the TAK-385 Licensed Compound or any TAK-385 Licensed Product in accordance with the terms and conditions set forth in this Article 5 (Development) and the plan for Development activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products (as such plan may be amended from time to time pursuant to this Section 5.3 (Development Plans) (with respect to the TAK-385 Development Plan), a “TAK-385 Development Plan”). [***]. The TAK-385 Development Plan will include reasonably detailed descriptions of: (a) all material Development activities reasonably anticipated to be undertaken by Licensee to obtain Regulatory Approval of the one or more TAK-385 Licensed Products in the Field in the Licensee Territory and in the Men’s Health Field in the Takeda Territory, (b) all Licensee Development Activities in the Takeda Territory, (c) all Initial Development Activities, (d) estimated dates on which Licensee expects to achieve each Development Milestone Event, including the filing of an NDA in each country in the Licensee Territory in which Licensee is Developing a TAK-385 Licensed Product, and (e) an estimate of costs and expenses associated with the activities set forth in the TAK-385 Development Plan. The initial TAK-385 Development Plan is attached hereto as Schedule 5.3 (TAK-385 Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (i) [***]; and (ii) [***], in each case consistent with the activities described in the initial TAK-385 Development Plan attached hereto as Schedule 5.3 (TAK-385 Development Plan). Licensee will prepare an update to the TAK-385 Development Plan at least annually. Licensee may amend the TAK-385 Development Plan as reasonable or necessary at any time during the Term; provided that all annual updates and any material amendments must be reviewed, discussed, and, solely with respect to any Development activities in the Takeda Territory, approved, by the JRC in accordance with Section 2.2.2(a) (Establishment; Responsibilities), and provided, further, that all such updates or material amendments to the TAK-385 Development Plan must be in accordance with the requirements of this Article 5 (Development). No update or amendment to the TAK-385 Development Plan related to Development activities in the Takeda Territory will be effective unless approved by the JRC in accordance with Arti...

Development Plans. (a) Coal Party and Gas Party acknowledge and agree that for the period from the Effective Time until the date Gas Party receives Coal Party’s Life of Mine Plan for a Mine, all operations of Gas Party throughout the Cooperation Area shall be deemed outside of any Mine Area. Coal Party shall, within sixty (60) days following the acquisition or permitting of any Mine, provide the pertinent Gas Party Representative with a Life of Mine Plan for such Mine; and Gas Party shall, within sixty (60) days following receipt of such Life of Mine Plan, provide the pertinent Coal Party Representative with a three (3) year plan generally describing the anticipated drilling and development activities of Gas Party (the “Gas Development Plan”) within the Mine Area of such Mine. (b) Other than with respect to calendar year 2017, each calendar year, with respect to each Mine in which Coal Party holds Coal Interests and in which Gas Party holds Gas Interests: (i) On or before October 1st of each calendar year, Coal Party will submit to the Coordination Committee (A) an update to the Life of Mine Plan for such Mine to extend such plan for an additional calendar year and to include any updates with respect to the calendar years already included in the Life of Mine Plan and (B) a plan for the anticipated mining activities of Coal Party during the following calendar year in such Mine Area, which shall include, with respect to each Mine, an accurate map of its current and completed mining areas, all then-permitted or planned Pillar Permit Areas for Gas Party’s well locations, line projections to designate its planned and proposed mining development headings and full extraction mining areas, and the proposed timing of such mining activities within such Mine Area, together with the location of Gas Party’s then-existing or planned ▇▇▇▇▇ or facilities as set forth in the most recent Annual Gas Development Plan that would reasonably be expected to be impacted by Coal Party’s mining operations in the Mine Area within the next six (6) years (the “Annual Coal Development Plan”); (ii) On or before October 1st of each calendar year, Gas Party will submit to the Coordination Committee (A) an update to the Gas Development Plan for such Mine to extend such plan for an additional calendar year and to include any updates with respect to the calendar years already included in the Gas Development Plan and (B) a plan generally describing the anticipated drilling and development activities of Gas Party...

Development Plans. 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication. 4.3.2 Each Development Plan will cover the next two years, and will include future development activities to be undertaken by Licensee, its Affiliates, or any Sublicensees during the next reporting period under Section 4.4 relating directly to the Licensed Product, Licensee’s strategy to bring the Licensed Product to commercialization, and projected timeline for completing the necessary tasks to accomplish the goals of the strategy. 4.3.3 Following receipt by Licensor of each Development Plan, Licensor will promptly notify Licensee of any comments or requested revisions, and the Parties will thereupon negotiate any appropriate revisions in good faith.

Development Plans. As soon as practicable after formation of the JDC, the JDC shall prepare and approve the initial Development Plan for Development of the Licensed Product for the Initial Indication in the formulation existing as of the Effective Date in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Development Plan is consistent with the general Development Plan outline set forth in Exhibit B attached hereto and incorporated herein (the “General Development Plan Outline”). The JDC shall prepare and approve a separate Development Plan for Development of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Development of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Development Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Development activities not contemplated by the then-current Development Plan. Amendments and revisions to the Development Plan shall be reviewed and discussed, in advance, by the JDC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Development Plan. Any amendment or revision to the Development Plan that provides for an increase or decrease in the number of FTEs as compared to the previous version of the Development Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Development Plan, or that moves forward the timetable for activities reflected in the Development Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Development activities to the amended or revised Development Plan. Each Development Plan shall identify the goals of the Development program contemplated thereunder and shall address Development activities related to the Licensed Compound or the Licensed Product (including, if applicable, any Other Indication Product or New Formulation), including: (i) the budget for Development Costs (and costs of Phase 4 Clinical Trials, if any) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted, including the number of FTEs (subject to Section 4.2) and the applicable FTE Rate and ou...

Development Plans. A Development Plan and budget for each Candidate for the balance of the Calendar Year during which the Compound or ▇▇▇▇▇▇ Compound is designated by the JSC as a Candidate shall be prepared by ▇▇▇▇▇▇ and submitted to the JSC promptly after the designation of such Compound or ▇▇▇▇▇▇ Compound as provided in Sections 2.1.4(h) and 3.6. Thereafter, for each Calendar Year during the Development Program, an updated Development Plan and budget for each Candidate shall be prepared by ▇▇▇▇▇▇ and submitted to the JSC as provided in Section 2.1.4(a) or (b), as applicable. To the extent JSC approval is required, the Parties shall manage the preparation of each Development Plan and budget in a manner designed to obtain such JSC approval no later than [*****] days prior to the end of the then-current Calendar Year. Each Development Plan and amendment thereto shall: (a) set forth (i) the Development objectives, activities, priorities, timelines, budget and resources for the Calendar Year covered by the Development Plan with reasonable specificity, (ii) the Development objectives and activities to be performed for each Calendar Year period covered by the Development Plan with reasonable specificity, broken down by Calendar Quarters, (iii) the Party that shall be responsible for performing such activities, (iv) a timeline for such activities and (v) the expected Development Costs over such Calendar Year; and (b) be consistent with the other terms of this Agreement.