Regulatory Transition Plan Clause Samples

Regulatory Transition Plan. 5.4.1 Licensor shall transfer the regulatory, clinical and operational responsibilities of the Existing Clinical Trial in accordance with the regulatory transition plan set forth in Schedule 5.4.1 with respect to the Existing Product (the “Regulatory Transition Plan”), which outlines the Parties’ responsibilities with respect to the Existing Clinical Trial. The Regulatory Transition Plan may be amended by the mutual written agreement of the Parties. Each Party shall conduct its responsibilities in accordance with the Regulatory Transition Plan and shall use best efforts to achieve the timelines set forth therein. 5.4.2 Notwithstanding Section 5.2, until the transfer of sponsorship and control of the Existing Clinical Trial to Company pursuant to the Regulatory Transition Plan, Licensor shall be responsible for any communications and interactions with Regulatory Authorities with respect to the Existing Clinical Trial in accordance with Section 5.2. Notwithstanding the foregoing, Licensor shall provide a copy of (a) any communications, notices, or other materials received from any Regulatory Authorities with respect to the Existing Clinical Trial, (b) any interim or final data or results from the Existing Clinical Trial, and (c) any proposed communications with, or submissions to, any Regulatory Authority reasonably in advance of submission and, with respect to clause (c), shall incorporate all of Company’s comments thereto in good faith (provided incorporation of such comments does not, upon the advice of ▇▇▇▇▇▇▇▇’s outside counsel, violate Law). 5.4.3 Prior to the transfer of all regulatory documentation for the Existing Clinical Trial held or filed by or on behalf of Licensor or its Affiliates prior to the Effective Date in accordance with the Regulatory Transition Plan (the “Existing Regulatory Documentation”), Licensor (or its designee) shall file, maintain, and hold title to such Existing Regulatory Documentation. Licensor shall not assign, license, or grant any right of reference or use to the Existing Regulatory Documentation except as expressly set forth in the Regulatory Transition Plan.
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Regulatory Transition Plan. Attached hereto as Schedule 3.3 is a regulatory transition plan (the “Regulatory Transition Plan”) agreed to by the Parties setting forth the activities to be performed by the Parties pursuant to this Agreement to effect the transfer and delivery of Governmental Permits and certain other Regulatory Products Rights to Cardiome, or to an entity designated by Cardiome in writing, and the target timelines therefor. The Parties acknowledge that the various submission dates set forth in Regulatory Transition Plan represent guidelines for timing of the relevant submissions that have been agreed to by the Parties and which the Parties will use commercially reasonable efforts to achieve, but are not intended to represent deadlines or binding commitments. Each Party shall promptly notify the other Party in the event that it determines that the activities and/or timelines set forth in the Regulatory Transition Plan require modification. The Transition Team shall be responsible for periodically reviewing and approving any changes to the Regulatory Transition Plan that are proposed by a Party and/or that are necessary to address any requests or requirements that may be imposed by Regulatory Authorities with respect to the transfer to Cardiome, or to an entity designated by Cardiome in writing, of the Governmental Permits. In each such event, the Parties shall use good faith efforts to agree upon a mutually acceptable means to address the relevant issues.
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Regulatory Transition Plan. [Redacted – list of regulatory activities and timelines] 6▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇.▇. ▇▇▇ ▇▇▇ Tel: 6▇▇-▇▇▇-▇▇▇▇ Fax: 6▇▇-▇▇▇-▇▇▇▇ Cardiome Announces worldwide sales and marketing of brinavess™ Vancouver, Canada, April xx, 2013 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has taken on responsibility for worldwide sales, marketing, and promotion of BRINAVESS™ (vernakalant IV) pursuant to a Transition Agreement signed with Merck, known as MSD outside the United States and Canada. Under the agreement, worldwide sales and marketing rights will transfer to Cardiome immediately. Pursuant to this agreement, Cardiome will continue to receive relevant royalties on worldwide sales. Cardiome will also receive an undisclosed promotional services fee. Regulatory product rights and product distribution responsibility are expected to transfer to Cardiome on or about July 15, 2013, following which Cardiome will recognize all BRINAVESS™ revenue and Merck will cease paying royalties or any promotional services fee. Merck will either terminate or transfer Sponsor responsibility for each relevant clinical study to Cardiome by September 15, 2013. “Executing this transition agreement with Merck and commencing direct worldwide commercial sales activities in support of BRINAVESS™, ahead of schedule, is a critical milestone in Cardiome’s history,” stated W▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D., President and CEO of Cardiome. “Outreach activities to physicians and caregivers who rely on BRINAVESS™ have resumed in select countries, which will enable us to gain valuable insight and experience in treating patients and help ensure a smooth transition of the product.”
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Regulatory Transition Plan. LICENSOR shall use Commercially Reasonable Efforts to ensure that ALZA or its Affiliates use Transitional Commercially Reasonable Efforts to complete the activities by the various dates set forth in a regulatory transition plan (“Regulatory Transition Plan”). LICENSEE shall promptly notify LICENSOR and ALZA in the event that LICENSEE determines that the activities and/or timelines set forth in the Regulatory Transition Plan require modification. LICENSOR shall use Commercially Reasonable Efforts to (a) ensure that ALZA or its Affiliates notify LICENSEE in the event that ALZA determines that the activities and/or timelines set forth in the Regulatory Transition Plan require modification and (b) notify LICENSEE in the event that LICENSOR determines that the activities and/or timelines set forth in the Regulatory Transition Plan require modification. The Transition Team shall be responsible for periodically reviewing and approving any changes to the Regulatory Transition Plan that are proposed by LICENSOR, LICENSEE or ALZA and/or that are necessary to address any requests or requirements that may be imposed by Regulatory Authorities in the Territory with respect to the transfer to LICENSEE of any Product Registrations or Regulatory Submissions. In such event, the Transition Team shall use good faith efforts to agree upon a mutually acceptable means to address the relevant issues. Notwithstanding anything to the contrary, the Regulatory Transition Plan shall be amended as agreed upon in writing by LICENSEE, LICENSOR, and ALZA.
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Regulatory Transition Plan. The Transition Team will agree on a regulatory transition plan (the “Regulatory Transition Plan”) setting forth the timelines and activities to be performed by the Parties and/or their Affiliates and/or Sublicensees pursuant to this Agreement to effect the transfer and delivery of all Governmental Permits, ALZA Regulatory Submissions, and certain other Product Rights to GENUPRO. The Parties shall use Commercially Reasonable Efforts to complete the activities by the various dates set forth in the Regulatory Transition Plan. Each Party shall promptly notify the other Party in the event that it determines that the activities and/or timelines set forth in the Regulatory Transition Plan require modification. The Transition Team shall be responsible for periodically reviewing and approving any changes to the Regulatory Transition Plan that are proposed by a Party and/or that are necessary to address any requests or requirements that may be imposed by Regulatory Authorities in the Territory with respect to the transfer to GENUPRO or its Affiliates and/or Sublicensees of any Governmental Permits or ALZA Regulatory Submissions. In such event, the Transition Team shall use good faith efforts to agree upon a mutually acceptable means to address the relevant issues.
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Regulatory Transition Plan 
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Related to Regulatory Transition Plan

  • 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.

  • 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.

  • Organizational Transition Local Church shall take all steps necessary to close and/or dissolve any legal entities of the Local Church and to settle, liquidate, or transfer all assets and obligations of such entities, or to establish any new legal entities, or to modify its current organizing documents as needed to effectuate its disaffiliation from The United Methodist Church, to the satisfaction of Annual Conference.

  • 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 (**).

  • Proposal of Corrective Action Plan In addition to the processes set forth in the Contract (e.g., service level agreements), if the Department or Customer determines that there is a performance deficiency that requires correction by the Contractor, then the Department or Customer will notify the Contractor. The correction must be made within a time-frame specified by the Department or Customer. The Contractor must provide the Department or Customer with a corrective action plan describing how the Contractor will address all performance deficiencies identified by the Department or Customer.