Common use of Pharmacovigilance Agreement Clause in Contracts

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.

Pharmacovigilance Agreement. Subject to the terms of this Agreement, and at a date to be determined by within [****]* after the JDCEffective Date, Facet BMS and Trubion PDL (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the actions responsibilities the Parties shall employ to protect patients and promote their well-being in a written agreement Agreement (hereinafter hereafter 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 and their Affiliates to fulfill, local and national regulatory reporting obligations to Governmental Authoritiesgovernment 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 * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDCBMS. 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 Sublicensees to comply with such obligations.

Pharmacovigilance Agreement. Subject to the terms of this Agreement, and at a date to be determined by within [ * ] after the JDCEffective Date, Facet BMS and Trubion Exelixis (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define re-define, re-state and finalize the actions responsibilities the Parties shall employ to protect patients and promote their well-being as initially stated in a written agreement the Pharmacovigilance Agreement dated as of August 13, 2008 (hereinafter hereafter referred to as the “Pharmacovigilance Agreement”)) for BMS-833923/XL139, including the addition of XL184, XL281 and any future Collaboration Compounds. 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 such Product. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and national regulatory reporting obligations to Governmental Authoritiesgovernment authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH International Council for Harmonisation (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 JDCBMS. 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 Sublicensees to comply with such obligations.