Development Transition Plan Clause Samples

Development Transition Plan. Promptly following the Merck Participation Election Date for a given Program, Moderna will prepare and provide to Merck a draft plan for the transition of any Development activities then being conducted by or on behalf of Moderna or its Affiliates from Moderna to Merck for such Program (including with respect to the PCV Program, Clinical Studies for Collaboration PCV Products) (a “Development Transition Plan”), which Development Transition Plan will be reviewed by the JDC and subject to the approval of the JSC. If and to the extent applicable, the Development Transition Plan will require Moderna to perform the following activities (provided that, for clarity, the Development Transition Plan shall not include any obligations for Moderna to provide to Merck any information or materials previously provided to Merck or to re-perform any activities that have already been transitioned to Merck), on the timeline set forth in the Development Transition Plan: (i) transfer and assign to Merck or its designee [***]; (ii) transfer to Merck [***]; (iii) deliver to Merck copies of all [***]; (iv) (A) with respect to the PCV Program, to the extent it is determined pursuant to [***] that [***] should be [***], at Merck’s request, reasonably assist Merck in [***] and (B) with respect to each Joint SAV Program, to the extent it is determined pursuant to [***] that [***] should be [***], at Merck’s request, reasonably assist Merck in [***]; and (v) deliver to Merck, in an electronic format (the form of which shall be agreed upon by the Parties), [***]. Each Party will use Commercially Reasonable Efforts to perform the obligations assigned to it under the Development Transition Plan in accordance with the timelines set forth therein. All costs and expenses incurred by or on behalf of the Parties (or their Affiliates) in connection with the conduct of the Development Transition Plan shall be considered Allowable Development Costs.
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Development Transition Plan. During the period from the Restated Effective Date until the completion of the transfer of Development activities from ARIAD to MERCK, ARIAD and MERCK shall each exercise Commercially Reasonable Efforts to expeditiously perform all activities set forth in the Development Transition Plan attached hereto as Schedule 4 within [***] ([***]) days after the Restated Effective Date. The Development Transition Plan may not be modified or amended without the written agreement of representatives of both Parties with responsibility for implementation of the Development Transition Plan, or the relevant portion thereof. Without limitation of the foregoing, ARIAD shall (A) as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan, transfer to MERCK all of its right, title and interest in all Regulatory Filings, Drug Approval Applications, Regulatory Approvals and DMFs then in its name applicable to Products in the Territory, if any; and all data bases and Confidential Information Controlled by ARIAD relating to such Regulatory Filings, Drug Approval Applications, Regulatory Approvals and DMFs; (B) as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan, notify the applicable Regulatory Authorities in the Territory and take any other action reasonably necessary to effect such transfer; (C) as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan, provide MERCK with copies of all correspondence between ARIAD and such Regulatory Authorities relating to such Regulatory Filings, Drug Approval Applications, Regulatory Approvals and DMFs; (D) unless expressly prohibited by any Regulatory Authority, as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan transfer control to MERCK of all Clinical Trials of such Product being conducted by or on behalf of ARIAD as of the Restated Effective Date and continue to conduct such trials, at MERCK’s sole discretion and expense to enable such transfer to be completed without interruption of any such trial; (E) as soon as reasonably practical following the Restated Effective Date, or as otherwise set forth in the Development Transition Plan, and subject to the remaining provisions of this Section 3.3.1, assign (or cause its Affiliates to assign) to ...
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Related to Development Transition Plan

  • Transition Plan In the event of termination by the LHIN pursuant to this section, the LHIN and the HSP will develop a Transition Plan. The HSP agrees that it will take all actions, and provide all information, required by the LHIN to facilitate the transition of the HSP’s clients.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • 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 ▇▇▇▇▇ then-existing and (II) in the aggregate, all ▇▇▇▇▇ 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 ▇▇▇▇▇ and Planned ▇▇▇▇▇ 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 ▇▇▇▇▇; (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 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.

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.