Regulatory Transition Plan definition

Regulatory Transition Plan shall have the meaning set forth in Section 3.3.
Sample 1Sample 2
Regulatory Transition Plan means the written plan attached hereto as Exhibit D, which will set forth the Regulatory Transition Activities to be conducted by Imara and Cardurion pursuant to Section 2.7.4, as such written plan may be amended, modified or updated from time-to-time in accordance with the terms of this Agreement.
Sample 1Sample 2Sample 3
Regulatory Transition Plan means the written plan to be prepared by the JRFT no later than […***…] after the Execution Date, as such period may be extended by mutual agreement of the Parties, which will set forth the Regulatory Transition Activities to be conducted by BeiGene and Novartis pursuant to Section 4.2.2, as such written plan may be amended, modified or updated by the mutual agreement of the Parties or, after the License Effective Date, the JDC.
Sample 1

Examples of Regulatory Transition Plan in a sentence

  • 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 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 conduct its responsibilities in accordance with the Regulatory Transition Plan and shall use best efforts to achieve the timelines set forth therein.

  • Within 15 days following the Effective Date, the Parties will exchange contact information for their respective local regulatory personnel in certain Countries and hereby agree to permit direct communications between such local regulatory personnel in such Countries in order to facilitate planning and implementation of certain aspects of the Regulatory Transition Plan.

  • The Regulatory Transition Plan may be amended by the mutual written agreement of the Parties.

  • Until the date of transfer of sponsorship and control of the Existing Clinical Trial to Company pursuant to the Regulatory Transition Plan in ​ accordance with Section 5.4, Licensor shall have the exclusive right and obligation to conduct the Existing Clinical Trial at Company’s cost.

  • 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.

  • On and after the date of transfer sponsorship and control of the Existing Clinical Trial to Company pursuant to the Regulatory Transition Plan in accordance with Section 5.4, as between the Parties, Company shall have the exclusive right to conduct the Existing Clinical Trial.

  • Prior to the transfer of any Regulatory Materials for the Licensed Compound held or filed by or on behalf of BeiGene or its Affiliates prior to the Effective Date (the “Existing Regulatory Materials”) in accordance the Regulatory Transition Plan, BeiGene (or its designee) shall, subject to Section 4.1, have the sole right to file, maintain, and hold title to such Existing Regulatory Materials.

  • Imara shall transfer to Cardurion, at Imara’s sole cost and expense, all Assigned Know-How, in accordance with the protocols and timeframes listed in the Regulatory Transition Plan; provided, that, Imara shall not be obligated to create any tangible embodiments of any such Assigned Know-How.


More Definitions of Regulatory Transition Plan

Regulatory Transition Plan means the written plan which will set forth the Regulatory Transition Activities to be conducted by Eisai and Pharmavant pursuant to Section 3.2.3, as such written plan may be amended, modified or updated from time-to-time in accordance with the terms of this Agreement.
Sample 1
Regulatory Transition Plan has the meaning set forth in Section 5.3 below.
Sample 1
Regulatory Transition Plan has the meaning set forth in Section 4.2.1 (Transfer of Regulatory Submissions).
Sample 1
Regulatory Transition Plan shall have the meaning set forth in Section 6.4 of this Agreement.
Sample 1

Related to Regulatory Transition Plan

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Transition Plan means a transition plan, acceptable to the LHIN that indicates how the needs of the HSP’s clients will be met following the termination of this Agreement and how the transition of the clients to new service providers will be effected in a timely manner; and

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Development Plans has the meaning set forth in Section 3.2.

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Regulatory Agreement means the regulatory agreement between HPD and the Owner establishing certain controls upon the operation of the Exemption Area during the term of the Exemption.

  • Parent Plan has the meaning set forth in Section 7.8(b).

  • Implementation Plan means the schedule included in the Statement of Work setting forth the sequence of events for the performance of Services under the Statement of Work, including the Milestones and Milestone Dates.

  • Technology Transfer Plan will have the meaning set forth in Section 4.1.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Company 401(k) Plan has the meaning set forth in Section 6.4(e).

  • EHC plan means an Education, Health and Care plan made under sections 37(2) of the Children and Families Act 2014.

  • Parent Plans has the meaning set forth in Section 6.4(c).

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Development Plan has the meaning set forth in Section 3.2.

  • Benchmark Transition Start Date means, in the case of a Benchmark Transition Event, the earlier of (a) the applicable Benchmark Replacement Date and (b) if such Benchmark Transition Event is a public statement or publication of information of a prospective event, the 90th day prior to the expected date of such event as of such public statement or publication of information (or if the expected date of such prospective event is fewer than 90 days after such statement or publication, the date of such statement or publication).

  • Company Superior Proposal shall have the meaning set forth in Section 7.4(b).

  • State implementation plan or “SIP” means the plan adopted by the state of Iowa and approved by the Administrator which provides for implementation, maintenance, and enforcement of such primary and secondary ambient air quality standards as they are adopted by the Administrator, pursuant to the Act.

  • service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • RBC plan means a comprehensive financial plan containing the elements specified in K.S.A. 40-2c06, and amendments thereto. If the commissioner rejects the RBC plan, and it is revised by the insurer, with or without the commissioner's recommendation, the plan shall be called the "revised RBC plan."

  • Benchmark Transition Event means the occurrence of one or more of the following events with respect to the then-current Benchmark: