Agreement/Safety Data Exchange Agreement Sample Clauses

Agreement/Safety Data Exchange Agreement. Prior to initiation of the first Clinical Study for each Product, the Parties shall negotiate in good faith and enter into an agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to such Product (each, a “Pharmacovigilance Agreement”). When executed, the Pharmacovigilance Agreement shall remain a stand-alone document, independent from this Agreement to enable amendment thereto as required independently of this Agreement. The Parties acknowledge that the prompt exchange of safety data is important to support the Parties’ regulatory reporting obligations, and therefore, the Pharmacovigilance Agreement shall contain provisions to ensure that adverse event and other pharmacovigilance information is exchanged in accordance with, and in a manner enabling both Parties to fulfill, all local, national, and regional regulatory reporting obligations under Applicable Laws. For clarity, the Pharmacovigilance Agreement shall continue to apply to Collaboration Indications for which a Party has exercised its Opt-Out Option.
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Related to Agreement/Safety Data Exchange Agreement

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  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • DISTRIBUTION OF CONTRACTOR PRICE LIST AND CONTRACT APPENDICES Contractor shall provide Authorized Users with electronic copies of the Contract, including price lists and Appendices, upon request. Contract Updates will be handled as provided in Appendix C – Contract Modification Procedures.

  • Client Agreement We are not required to enter into a written agreement complying with the Code relating to the services that are to be provided to you.

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  • FRAMEWORK AGREEMENT MANAGEMENT The Parties shall manage this Framework Agreement in accordance with Schedule 14 (Framework Management).

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  • Change Orders and Contract Amendments 33.1 The Procuring Entity may at any time order the Supplier through notice in accordance GCC Clause 8, to make changes within the general scope of the Contract in any one or more of the following: a) drawings, designs, or specifications, where Goods to be furnished under the Contract are to be specifically manufactured for the Procuring Entity; b) the method of shipment or packing; c) the place of delivery; and d) the Related Services to be provided by the Supplier. 33.2 If any such change causes an increase or decrease in the cost of, or the time required for, the Supplier's performance of any provisions under the Contract, an equitable adjustment shall be made in the Contract Price or in the Delivery/Completion Schedule, or both, and the Contract shall accordingly be amended. Any claims by the Supplier for adjustment under this Clause must be asserted within twenty-eight (28) days from the date of the Supplier's receipt of the Procuring Entity's change order. 33.3 Prices to be charged by the Supplier for any Related Services that might be needed but which were not included in the Contract shall be agreed upon in advance by the parties and shall not exceed the prevailing rates charged to other parties by the Supplier for similar services.

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