Regulatory Transition Plan Sample Clauses

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 Xxxxxxxx’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] 6000 Xxxxxxxx Xxxx, Xxxxx 000 Xxxxxxxxx, X.X. X0X 0X0= Tel: 600-000-0000 Fax: 600-000-0000 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 Wxxxxxx Xxxxxx, 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. 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. 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 
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Related to Regulatory Transition Plan

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • 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.

  • Development Plans Shipper has provided Gatherer with a report attached hereto as Exhibit D (the “Current Development Plan”) describing in detail, as of January 1, 2017, the planned development, drilling, and production activities to take place with respect to Dedicated Production for the applicable Development Period. The information contained in the 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 (**). Current Development Plan is broken out on a Subsystem-by-Subsystem basis and, 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, and production activities that Shipper expects to take place with respect to Dedicated Production for the then-applicable Development Period. Shipper and Gatherer shall each make their respective representatives available to participate in such meetings and discussions. No later than August 1 of each such Year, Shipper shall provide (or cause to be provided) to Gatherer 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, and production activities to take place with respect to Dedicated Production for the then-applicable Development Period (any such update, an “Updated Development Plan” and, together with the Current Development Plan, each, a “Development Plan”). Notwithstanding anything herein to the contrary, in no event shall Gatherer be required to agree to any Updated Development Plan and corresponding updated Gathering System Plan that contains a Committed Build-Out that (i) has a corresponding Target Completion Date that occurs after the end of the Initial Term, and (ii) Gatherer, in its sole discretion, does not wish to approve. (b) Each proposed Development Plan shall include information as to the following, in each case, broken out on a Subsystem-by-Subsystem basis and, 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) all Xxxxx that, as of the date such Development Plan was delivered, are currently in existence and (A) the production therefrom is being delivered into the Gathering System, or (B) are awaiting connection to the Gathering System; (ii) the 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 the estimated timing of the drilling of such Planned Xxxxx; (iii) forward-looking production estimates for the applicable time period covered by such Development Plan for all Shipper Gas (A) that Shipper reasonably and in good faith believes will become owned or Controlled by Shipper 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, any Planned Xxxxx included in such Development Plan (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 (**). (iv) forward-looking estimates for the applicable time period covered by such Development Plan of the aggregate volumes of those Shipper Injected Liquids that Shipper intends to Tender to the Injection Points hereunder to receive the System Services (such estimates, both with respect to a particular Quarter and an entire Year, the “System Liquids Estimates” and, together with the Dedicated Production Estimates, the “System Production Estimates”); (v) (A) each new receipt point (including the location thereof) proposed by Shipper with respect to the System Production Estimate reflected in such Development Plan (each such receipt point, including those located at the site of a Planned Well, a “Planned Receipt Point”), (B) each Receipt Point at which Shipper expects to Tender Shipper Gas and/or Shipper Injected Liquids reflected in such Development Plan into the Gathering System, and (C) the estimated portion of the System Production Estimate contained in such Development Plan that Shipper expects to Tender at each such Receipt Point and Planned Receipt Point; (vi) the earliest date on which each Planned Well included in the Development Plan is estimated to be completed and producing, 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 Well was delivered to Gatherer hereunder; (vii) 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 Shipper may utilize the existing and historical production information from similarly situated Xxxxx; (viii) (A) each new delivery point (including the location thereof) proposed by Shipper with respect to the System Production Estimate reflected in such Development Plan (each such delivery point, a “Planned Delivery Point”), (B) each Delivery Point at which Shipper expects Shipper Gas produced from the Xxxxx and Planned Xxxxx reflected in such Development Plan to be redelivered to Shipper, (C) each Delivery Point at which Shipper expects any Drip Liquids allocated to Shipper in accordance with this Agreement and/or Shipper Injected Liquids to be redelivered to Shipper, and (D) the estimated portion of the System Production Estimate contained in such Development Plan that Shipper expects to be redelivered to Shipper at each such Delivery Point and Planned Delivery Point; (ix) any (A) proposed revision to the then-existing Dedicated Area and/or any then-existing Dedicated Contract and/or (B) any new contract that Shipper proposes to be a Dedicated Contract; and (x) other information reasonably requested by Gatherer that is relevant to the design, construction, and operation of the Gathering System, including (A) any Subsystem Extension proposed by Shipper, (B) the relevant Receipt Point, Planned Receipt Point, Delivery Point and Planned Delivery Point facilities applicable to such 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, and (C) any treating, processing, or liquids handling facilities proposed by Shipper that may be required for any Shipper Gas and/or Shipper Injected Liquids to meet applicable Downstream Facility specifications at the Delivery Points.

  • Implementation Plan The Authority shall cause to be prepared an Implementation Plan meeting the requirements of Public Utilities Code Section 366.2 and any applicable Public Utilities Commission regulations as soon after the Effective Date as reasonably practicable. The Implementation Plan shall not be filed with the Public Utilities Commission until it is approved by the Board in the manner provided by Section 4.9.

  • Transition Planning The AGENCY will be responsible for the development of the student’s Transition Plan, which begins upon entry and is completed prior to the student’s exit.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Marketing Plans Contractor and the Exchange recognize that Enrollees and other health care consumers benefit from efforts relating to outreach activities designed to increase heath awareness and encourage enrollment. The parties shall share marketing plans on an annual basis and with respect to periodic updates of material changes. The marketing plans of each of the Exchange and Contractor shall include proposed marketing approaches and channels and shall provide samples of any planned marketing materials and related collateral as well as planned, and when completed, expenses for the marketing budget. The Contractor shall include this information for both the Exchange and the outside individual market. The Exchange shall treat all marketing information provided under this Section as confidential information and the obligation of the Exchange to maintain confidentiality of this information shall survive termination or expiration of this Agreement.

  • Staffing Plan The Board and the Association agree that optimum class size is an important aspect of the effective educational program. The Polk County School Staffing Plan shall be constructed each year according to the procedures set forth in Board Policy and, upon adoption, shall become Board Policy.

  • 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.

  • Option Plans There is no share option plan or similar plan to acquire any additional shares or units or other equity interests, as the case may be, of IEM or securities convertible or exercisable into or exchangeable for, or which otherwise confer on the holder thereof any right to acquire, any such additional shares or units or equity interests, as the case may be.

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