Cooperation, Consultation and Review Sample Clauses

Cooperation, Consultation and Review. The Parties shall cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate and responsive manner and shall assist the other Party as reasonably requested in connection with the preparation and filing of Regulatory Materials in the Licensed Field, whether in or outside of the Territory. The Parties shall establish a joint regulatory working group to manage Licensed Product regulatory activities and issues. It is the intention of the Parties that the joint regulatory working group shall meet (in person or via teleconference) on an as-needed basis after the Effective Date and throughout the Term, but at a minimum on a quarterly basis. The Parties agree and acknowledge that the activities of Ultragenyx with respect to (i) Licensed [***] Products in the Ultragenyx Field and (ii) Licensed Analog Products in the Licensed Field and the activities of Takeda with respect to (A) Licensed [***] Products in the Takeda Field and (B) Licensed Products outside of the Licensed Field, shall be coordinated such that they are consistent with the overall objective of facilitating Regulatory Approvals.
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Cooperation, Consultation and Review. The Parties shall cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate and responsive manner and shall assist the other Party as reasonably requested in connection with the preparation and filing of Regulatory Materials in the Field. Each Party shall assist the other Party, as is reasonably necessary, in order for such Party to obtain and maintain the Product INDs and the Product NDAs, including in connection with the preparation and filing of Regulatory Materials necessary to maintain such Product INDs and Product NDAs.
Cooperation, Consultation and Review. (a) The Parties shall cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate and responsive manner and shall assist the other Party as reasonably requested in connection with the preparation and filing of Regulatory Materials in the Licensed Field, whether in or outside of the Territory. The Parties shall establish a joint regulatory working group to manage Licensed Product regulatory activities and issues. It is the intention of the Parties that the joint regulatory working group shall meet (in person or via teleconference) on an as-needed basis after the Effective Date and throughout the Term, but at a minimum on a quarterly basis. The Parties agree and acknowledge that the activities of Ultragenyx with respect to (i) Licensed [***] Products in the Ultragenyx Field and (ii) Licensed Analog Products in the Licensed Field and the activities of Takeda with respect to (A) Licensed [***] Products in the Takeda Field and (B) Licensed Products outside of the Licensed Field, shall be coordinated such that they are consistent with the overall objective of facilitating Regulatory Approvals. (b) The other Party shall assist the Lead Regulatory Party, as is reasonably necessary, in order for the Lead Regulatory Party to obtain and maintain the Product INDs and the Product Regulatory Approvals, including in connection with the preparation and filing of Regulatory Materials necessary to maintain such Product INDs and Product Regulatory Approvals.
Cooperation, Consultation and Review. The Parties shall establish a joint regulatory working group and shall cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate and responsive manner. Each Party shall assist the other Party as such other Party may reasonably request in connection with the preparation and filing of all Regulatory Materials contemplated in this Article 5. Each Party shall provide the other Party with copies of any proposed Regulatory Materials to be submitted by such Party (other than routine correspondence) and shall reasonably consider any comments thereto provided by the other Party to the extent practicable.
Cooperation, Consultation and Review. Through the JD&RC, the Parties shall cooperate with each other to achieve the regulatory objectives with respect to the Vaccine in the 94065460_6 Novavax Territory and the Takeda Territory in a timely, accurate and responsive manner. Each Party shall provide the other Party with copies of any proposed Regulatory Materials to be submitted by such Party (other than routine correspondence) in its own Territory in the world (i.e. Novavax in the Novavax Territory and Takeda in the Takeda Territory), as applicable, and shall reasonably consider any comments thereto provided by the other Party to the extent practicable. Novavax shall assist Takeda, as Takeda may reasonably request, in connection with the preparation and filing of all Regulatory Materials with Regulatory Authorities in the Takeda Territory as contemplated in this ARTICLE 6. Takeda shall assist Novavax, as Novavax may reasonably request, in connection with the preparation and filing of all Regulatory Materials with Regulatory Authorities in the Novavax Territory as contemplated in this ARTICLE 6. Within [***] after receipt of an invoice, the requesting Party will reimburse the assisting Party for all reasonable and documented expenses incurred by the assisting Party in connection with this Section 6.3.

Related to Cooperation, Consultation and Review

  • Cooperation and Coordination The Parties acknowledge and agree that it is their mutual objective and intent to minimize, to the extent feasible and legal, taxes payable with respect to their collaborative efforts under this Agreement and that they shall use all commercially reasonable efforts to cooperate and coordinate with each other to achieve such objective.

  • Notification and Consultation 1. A Party shall promptly notify the other Party in writing upon: (a) initiating a bilateral safeguard proceeding under this Section; (b) applying a provisional bilateral safeguard measure; and (c) taking a final decision to apply or extend a bilateral safeguard measure. 2. A Party shall provide to the other Party a copy of the public version of the report of its competent investigating authority in accordance with Article 8.4.1. 3. Upon request of a Party whose good is subject to a bilateral safeguard proceeding under this Section, the Party conducting that proceeding shall enter into consultations with the requesting Party to review a notification under paragraph 1 or any public notice or report that the competent investigating authority has issued in connection with the proceeding. 4. All notifications during any bilateral safeguard investigation shall be exchanged in English.

  • INFORMATION AND CONSULTATION 8.1 You are entitled under the General Data Protection Regulation to access personal data we hold on you in our housing files. We will provide you with a copy of any such information we hold within one calendar month of your request. You may have other rights under the General Data Protection Regulation in relation to your personal data, which we will honour. You are entitled to check information you have provided in connection with your housing application free of charge. 8.2 We will publish an annual report on our housing management performance which, you may obtain from us on request. We will give you information about our complaints procedure. 8.3 On request, we will provide you with free information relating to: ▪ The terms of your tenancy; ▪ Our policy and procedures on setting rent and service charges; ▪ Our policy and rules about; o Admission to the housing lists; o Allocations; o Transfer of tenants between houses; o Exchanges of houses between our tenants, and tenants of other landlords; o Repairs and maintenance; o Our tenant participation strategy; o Our arrangements for taking decisions about housing management and services. 8.4 We will consult you about making or changing: ▪ Policies regarding housing management, repairs and maintenance if the proposal is likely to significantly affect you; ▪ Proposals for changes in rent and service charges where they affect all or a class of tenants (and you are to be affected); ▪ Proposals for the sale or transfer of your house to another landlord; ▪ Decisions about the information to be provided relating to our standards of housing management and performance; ▪ Performance standards or targets in relation to housing management repairs and maintenance; ▪ Our tenant participation strategy. We will take into account any views that you have before making a final decision. Any consultation with you will include giving you comprehensive information in an accessible form and reasonable time to express views.

  • Implementation and Review The Parties shall consult annually, or as otherwise agreed, to review the implementation of this Chapter and consider other matters of mutual interest affecting trade in services. (10) 10 Such consultations will be addressed under Article 170 (Free Trade Commission) of Chapter 14 (Administration of the Agreement).

  • Union Consultation The Union is entitled to consult the Employer or its representative, whenever it is alleged that Employees are required to work unreasonable amounts of overtime.

  • JOINT CONSULTATION 25.01 The parties acknowledge the mutual benefits to be derived from joint consultation and will consult on matters of common interest. 25.02 The subjects that may be determined as appropriate for joint consultation will be by mutual agreement of the parties. 25.03 Wherever possible, the Council shall consult with representatives of the Professional Institute at the appropriate level about contemplated changes in conditions of employment or working conditions not governed by this Agreement.

  • Examination and Review (i) After receipt of the Closing Working Capital Statement, Seller will have *** (***) days from the date on which Buyer has provided to Seller all access and information reasonably requested for such purposes (the “Review Period”) to review the Closing Working Capital Statement. During the Review Period, Seller and its accountants will have full access to the relevant books and records of Buyer, the personnel of, and work papers prepared by, Buyer and/or Buyer’s accountants to the extent that they relate to the Closing Working Capital Statement and to such historical financial information (to the extent in Buyer’s possession) relating to the Closing Working Capital Statement as Seller may reasonably request for the purpose of reviewing the Closing Working Capital Statement and to prepare a Statement of Objections. (ii) On or prior to the last day of the Review Period, Seller may object to the Closing Working Capital Statement by delivering to Buyer a written statement setting forth Seller’s objections in reasonable detail, indicating each disputed item or amount and the basis for Seller’s disagreement therewith (the “Statement of Objections”). If Seller fails to deliver the Statement of Objections before the expiration of the Review Period, then the Closing Working Capital Statement and the Post-Closing Adjustment, as the case may be, reflected in the Closing Working Capital Statement will be deemed to have been accepted by Seller. If Seller delivers the Statement of Objections before the expiration of the Review Period, Buyer and Seller will negotiate in good faith to resolve such objections within *** (***) days after the delivery of the Statement of Objections (the “Resolution Period”), and, if the same are so resolved within the Resolution Period, then the Post-Closing Adjustment and the Closing Working Capital Statement with such changes as may have been previously agreed in writing by Buyer and Seller, will be final and binding.

  • Consultation 10.1 The Employer agrees to consult the Employee timeously where the exercising of its powers will have amongst others- 10.1.1 A direct effect on the performance of any of the Employee’s functions; 10.1.2 Commit the Employee to implement or to give effect to a decision made by the Employer; and 10.1.3 A substantial financial effect on the Employer. 10.2 The Employer agrees to inform the Employee of the outcome of any decisions taken pursuant to the exercise of powers contemplated in clause 12.1 as soon as is practicable to enable the Employee to take any necessary action with delay.

  • Consultation Services The company hereby employs the consultant to perform the following services in accordance with the terms and conditions set forth in this agreement: The consultant will consult with the officers and employees of the company concerning matters relating to the management and organization of the company, their financial policies, the terms and conditions of employment, and generally any matter arising out of the business affairs of the company.

  • Technical Consultations If a Party has a significant concern with respect to food safety, plant health, or animal health, or an SPS measure that the other Party has proposed or implemented, that Party may request technical consultations with the other Party. The Party that is the subject of the request should respond to the request without undue delay. Each Party shall endeavour to provide the information necessary to avoid a disruption to trade and, as the case may be, to reach a mutually acceptable solution.

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