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Phase III Plan Sample Clauses

Phase III Plan. (1) If both Parties’ JDC representatives agree that a Product Candidate under a Joint Phase IIb Plan is ready for Phase III Clinical Studies in an Indication, then the JDC shall prepare a written Development plan and budget for the Phase III Development of such Product Candidate for such Indication with the goal of obtaining Regulatory Approval for the U.S./Europe/Japan Region and the ROW Region, which shall include a clinical plan and a protocol for such Phase III Clinical Study(ies) based on the EOP2 Meeting briefing package, incorporating any feedback received from each Regulatory Authority, as well as all other Development activities, including Non-Clinical Studies and CMC Development, that are required to support Regulatory Approval of the Product containing such Product Candidate in such Indication for the U.S./Europe/Japan Region and the ROW Region, and which Development plan shall assign responsibility for such Development activities between the Parties, and shall include the timeline and budget for such Development activities (the “Phase III Plan”). (2) If the JDC cannot agree on such Phase III Plan within [***] days after both Parties’ JDC representatives agree that such Product Candidate is ready for Phase III Clinical Studies in an Indication, the matter shall be referred to the JEC for resolution. If the JEC cannot agree on such Phase III Plan within a [***]-day period, then such matter shall be referred to the Senior Officers of the Parties for resolution. If such Senior Officers cannot agree on such Phase III Plan within a [***]-day period, then [***].
Phase III Plan. If both Parties’ JDC representatives agree that a Product Candidate under a Joint Phase IIb Plan is ready for Phase III Clinical Studies in an Indication, then the JDC shall prepare a written Development plan and budget for the Phase III Development of such Product Candidate for such Indication with the goal of obtaining Regulatory Approval for the U.S./Europe/Japan Region and the ROW Region, which shall include a clinical plan and a protocol for such Phase III Clinical Study(ies) based on the EOP2 Meeting briefing package, incorporating any feedback received from each Regulatory Authority, as well as all other Development activities, including Non-Clinical Studies and CMC Development, that are required to support Regulatory Approval of the Product containing such Product Candidate in such Indication for the U.S./Europe/Japan Region and the ROW Region, and which Development plan shall assign responsibility for such Development activities between the Parties, and shall include the timeline and budget for such Development activities (the “ Phase III Plan ”).
Phase III Plan. As the first step of Phase III, the AOL Project -------------- Manager and the Purchase Pro Project Manager shall form a planning team for Phase III which shall proceed to prepare a detailed plan for the specifications, design, implementation, launch and operation of the Phase III Version ("Phase III Plan"). Such planning team shall consist of the AOL Project Manager, the Purchase Pro Project Manager, the equivalent of a total of approximately five (5) full-time personnel from AOL and five (5) full-time personnel from Purchase Pro, and such other personnel from AOL and Purchase Pro as each of them shall designate. The planning process shall commence at such time as AOL and Purchase Pro shall mutually agree but shall commence prior to completion of Phase II. The parties shall use commercially reasonable efforts to complete the Phase III Plan within thirty (30) days after commencement thereof. Any dispute or deadlock relating to the contents of the Phase III Plan that are to be mutually determined by AOL and Purchase Pro shall be resolved pursuant to the procedure set forth in Section 13.1 below. The Phase III Plan shall set forth the following: (a) The specifications for and the technical standards to be supported by the Phase III Version of the Platform, which shall be mutually determined by AOL and Purchase Pro. (b) The specifications for and the anticipated features and functionality of the Phase III Version of the AOL Exchange, which shall be designated by AOL (consistent with the specifications and features, functions, technical standards and capability or capacity of the Platform determined under Section 4.2(a)). (c) The Purchase Pro Technology to be included in or used with the Phase III Version and the Platform, which shall be designated by AOL in consultation with Purchase Pro and licensed to AOL by Purchase Pro under Section 7.1

Related to Phase III Plan

  • 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 Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Phase 2 Phase 2 is expected to consist of Member Nodes and a select number of Nodes operated by non-Members. The non-Member Nodes will be required to comply with Node hosting terms as set forth by the Council, which may be amended from time to time (the “General Node Terms”).

  • Commercialization Plan At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved by the JGC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as part of the U.S. Development & Commercialization Program. (d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Development Plans Customer has provided Provider with a report attached hereto as Exhibit D (the “Current Development Plan”) describing in detail, as of January 1, 2017, the planned development, drilling, production, processing, treating, marketing and other activities to take place with respect to Dedicated Production and Customer Injected NGLs for the applicable Development Period. The information contained in the Current Development Plan is, with respect to the first three Years covered by the Current Development Plan, on a Quarter-by-Quarter basis, and with respect to the remaining Years covered by the Current Development Plan, on a Year-by-Year basis. The Current Development Plan attached hereto has been approved by the Parties. (a) From time to time during each Year of the Term, the Parties shall meet to discuss the planned development, drilling, production, processing, treating, marketing and other activities that Customer expects to take place with respect to Dedicated Production and Customer Injected NGLs for the then-applicable Development Period. Customer and Provider shall each make their respective representatives available to participate in such meetings and discussions. No later than August 1 of each such Year, Customer shall provide (or cause to be provided) to Provider a proposed update of the then-currently agreed Development Plan, prepared on the same basis as the Current Development Plan and describing in detail the planned development, drilling, production, processing, treating, marketing and other activities to take place with respect to Dedicated Production and Customer Injected NGLs for the then-applicable Development Period (any such update, an “Updated Development Plan” and, together with the Current Development Plan, each, a “Development Plan”). (b) Each proposed Development Plan shall include information as to the following, in each case, broken out, with respect to the first three Years covered by such Development Plan, on a Quarter-by-Quarter basis, and, with respect to the remaining Years covered by such Development Plan, on a Year-by-Year basis: (i) forward-looking production estimates for the applicable time period covered by such Development Plan for all Customer Gas and Customer Injected NGLs (A) that Customer reasonably and in good faith believes will become owned or Controlled by Customer during the time period covered by such Development Plan, and/or (B) that will be produced from (I) in the aggregate, all Xxxxx then-existing and (II) in the aggregate, all Xxxxx that are expected to be drilled during the time period covered by such Development Plan (each such Well reflected in such Development Plan, a “Planned Well” and, such collective estimates described in subsections (A) and (B), both with respect to a particular Quarter and an entire Year, the “Dedicated Production Estimates”); TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). (ii) (A) each new receipt point (including the location thereof) proposed by Customer with respect to the Dedicated Production Estimate reflected in such Development Plan (each such receipt point, a “Planned Receipt Point”), (B) each Receipt Point at which Customer expects to Tender Customer Gas or Customer Injected NGLs reflected in such Development Plan into the TGP System, and (C) the estimated portion of the Dedicated Production Estimate contained in such Development Plan that Customer expects to Tender at each such Receipt Point and Planned Receipt Point; (iii) (A) each new delivery point (including the location thereof) proposed by Customer with respect to the Dedication Production Estimate reflected in such Development Plan (each such delivery point, a “Planned Delivery Point”), (B) each Delivery Point at which Customer expects to Nominate Customer Residue Gas or Customer NGLs produced from the Dedicated Production Estimate reflected in such Development Plan to be redelivered to Customer, and (C) the estimated volumes of Customer Residue Gas and Customer NGLs produced from the Dedication Production Estimate contained in such Development Plan that Customer expects to Nominate to each such Delivery Point; (iv) the earliest date on which each Planned Receipt Point and Planned Delivery Point included in the Development Plan is required by Customer to be placed into service, which date shall not be earlier than three Months after the January 1st that is immediately subsequent to the date that the Development Plan that initially reflected such Planned Receipt Point or Planned Delivery Point was delivered to Provider hereunder; (v) the anticipated characteristics of the production from the Xxxxx and Planned Xxxxx reflected in such Development Plan (including liquids content and gas and liquids composition) and the projected production volumes and production pressures applicable thereto; provided that Customer may utilize the existing and historical production information from similarly situated Xxxxx; (vi) any (A) proposed revision to the then-existing Dedicated Area and/or any then-existing Dedicated Contract and/or (B) any new contract that Customer proposes to be a Dedicated Contract; and (vii) other information reasonably requested by Provider that is relevant to the design, construction, and operation of the TGP System, including (A) any applicable Plant Expansion or Facilities Modification proposed by Customer, (B) the relevant Receipt Point and Planned Receipt Point facilities applicable to such Development Plan, and (C) the relevant Delivery Point and Planned Delivery Point facilities applicable to such Development Plan. TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**).

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • PHASE is a distinct portion of the Work to be provided under this Agreement, as specified in the Statement Of Work.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Program Budget A) Contractor will expend funds received for operation of its program and services according to Contractor’s annual operating budget. The portions of said budget, which reflect services performed or money paid to Contractor pursuant to this Agreement shall be subject to the approval of the Human Services Agency. B) In the event Contractor determines a reasonable business necessity to transfer funding between personnel and operating expenses specified in the budget submitted to the Human Services Agency the following will apply: 1. Contractor will notify the Human Services Agency of transfers that in the aggregate are between ten percent (10%) and twenty percent (20%) of the maximum contract amount.