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. Without limitation of Section 5.4, the Parties shall meet, as soon as practical following the Effective Date, but in no event later than four (4) weeks after the Effective Date of this Agreement, to commence good faith negotiations to establish a detailed pharmacovigilance agreement relating to the Product, which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions/adverse events sufficient to permit each Party to comply with its regulatory and other legal obligations within applicable timeframes.
Pharmacovigilance Agreement. The term “
Pharmacovigilance Agreement. To the extent required by Applicable Law, the Parties shall execute a safety data exchange or other applicable pharmacovigilance agreement.
Pharmacovigilance Agreement. Within [**] after the Effective Date, the Parties (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) will define and finalize the Parties’ responsibilities with respect to pharmacovigilance activities in a written Pharmacovigilance Agreement. Such Pharmacovigilance Agreement will provide for the receipt, investigation, recording, communication, and exchange by the Parties of information that a Party becomes aware of in the Territory and globally concerning adverse events in or involving a research patient or subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Such guidelines and procedures will be in accordance with, and will enable each Party and its Affiliates to fulfill, local and international regulatory reporting obligations to Regulatory Authorities. Subject to compliance with Applicable Law, each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement (as the Parties may agree to modify it from time-to-time) and to cause its Affiliates and licensees and permitted sublicensees (as applicable) to comply with such obligations. It is understood that each Party and its Affiliates or licensee or permitted sublicensees (as applicable) will have the right to disclose Safety Data if such disclosure is reasonably necessary to comply with Applicable Laws and regulations and requirements of Regulatory Authorities within the Territory (or outside of the Territory with respect to Akebia) with respect to its filings and activities related to the Licensed Product.
Pharmacovigilance Agreement. Within [***] after the Effective Date, BMS and the Company (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in connection with the use of the Licensed Compound(s) until such time that all pharmacovigilance responsibilities have transferred from BMS to Company. 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 Licensed Compound(s). Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities. Furthermore, such agreed procedures shall be consistent with relevant International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the Party responsible for pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound(s) subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting obligations are fulfilled. Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Pharmacovigilance Agreement. The Parties mutually agree to execute a separate Pharmacovigilance Agreement as deemed applicable by the Parties specifying the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of each Product and Licensed Product and their related activities.
Pharmacovigilance Agreement. Either Party may terminate a particular Study under this Agreement immediately upon written notice to the other Party if (a) the Parties do not execute a Pharmacovigilance Agreement for such Study within the timeframe set forth in Section 4.5 or (b) the terminating Party determines in good faith that such Study represents an unjustified risk to the safety of patients in the applicable Study Field.
Pharmacovigilance Agreement. Prior to the MA Transfer Date, and in time to ensure that all regulatory requirements are met, the Parties shall enter into a Pharmacovigilance Agreement for one of the Products, namely Visken, which will be attached hereto as Annex 7 after execution.
Pharmacovigilance Agreement. Details regarding the management of information of adverse events related to the clinical development and the use of the Licensed Product in the Licensed Territory and the SGI Territory will be delineated in a separate pharmacovigilance agreement that shall be agreed to by the Parties prior to the earlier of (a) Commercialization of the Licensed Product in any country in the Territory or (b) the preparation of any Regulatory Materials by MPI (the “Pharmacovigilance Agreement”). Each Party will be primarily responsible for submission of all required reports with respect to adverse events where such Party is obligated to do so under applicable Law. As of the Effective Date, the Parties acknowledge SGI maintains the global safety database for the Licensed Product. The Parties shall discuss which Party should maintains the database and, if the Parties mutually agree that such database shall be maintained by MPI, the Parties shall cooperate to transition such database to MPI. The maintaining [***] included in such database.
