Pharmacovigilance Agreement Clause Samples
A Pharmacovigilance Agreement is a contractual provision that outlines the responsibilities and procedures for monitoring, reporting, and managing the safety of pharmaceutical products between collaborating parties, such as a manufacturer and a distributor. This clause typically details how adverse event information will be shared, the timelines for reporting safety data, and the roles each party plays in ensuring regulatory compliance. Its core function is to ensure that both parties coordinate effectively to meet legal obligations for drug safety monitoring, thereby protecting patient safety and minimizing regulatory risk.
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Pharmacovigilance Agreement. The Parties will execute the Pharmacovigilance Agreement prior to MSD Delivering MSD Compound to Collaborator hereunder. The Pharmacovigilance Agreement will: (i) include safety data exchange procedures; (ii) facilitate appropriate safety reviews; (iii) govern the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or related to the use of the MSD Compound and Collaborator Compound in the MSD Compound Study; and (iv) enable the Parties and their Affiliates to fulfill local and international regulatory reporting obligations to Regulatory Authorities, all of the foregoing in accordance with Applicable Law. For the avoidance of doubt, the obligations to provide safety data under the Pharmacovigilance Agreement will be independent of any obligations to provide safety data pursuant to this Agreement.
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. The Parties shall cooperate with respect to the reporting and handling of safety information involving or relating to the Licensed Products to the extent required by Applicable Laws. To the extent required by Applicable Laws or any Regulatory Authority, the Parties shall enter into a written agreement containing customary terms that will govern the exchange of Adverse Events and other safety information reporting obligations relating to the Licensed Products (the “Pharmacovigilance Agreement”) to ensure that such Adverse Events and other safety information is exchanged and reported to the relevant Regulatory Authorities in compliance with Applicable Laws and the requirements of Regulatory Authorities. In the event that a Pharmacovigilance Agreement is not so required, if requested by Novartis in writing, the Parties shall enter into a high-level written agreement that will govern the exchange of validated safety signals for the Licensed Products, which agreement shall be entered into [***]. (b) Transfer of Legacy Safety Data. Legacy safety data (including Serious Adverse Event Reports, pregnancy reports and Investigator Notifications) arising out of the Licensor Clinical Trial Activities shall be transferred from Licensor to Novartis in accordance with the Data Protection Laws. The Parties acknowledge that transfer of such legacy safety data will require mutual cooperation between the Parties and the Parties will use reasonable efforts to complete such transfer as soon as possible and in time for Novartis to submit or hold its first IND for the Licensed Products. In the event that any IND or Clinical Trial authorization is transferred from Licensor to Novartis, Licensor shall continue to be liable for and indemnify, defend and hold harmless Novartis and its Affiliates from and against all and any Losses arising out of, or in connection with: (i) any failure of Licensor to perform its obligations related to all safety data arising out of the Licensor Clinical Trial; and (ii) any related safety issues reported as individual case safety reports (“ICSRs”) during the period in which Licensor held such IND. Licensor represents and warrants that all safety data with respect to the Licensor Clinical Trial has been properly collected in accordance with Applicable Laws and that all ICSRs and other required regulatory safety reports (e.g., Development Safety Update Reports (“DSURs”)), as well as any safety issues with respect to the Licensor Clinical Trial have been ...
Pharmacovigilance Agreement. To the extent required by Applicable Law, the Parties shall execute a safety data exchange or other applicable pharmacovigilance agreement.
Pharmacovigilance Agreement. The Parties shall execute a separate pharmacovigilance agreement if required specifying the procedures and timelines for compliance with applicable Laws and regulations pertaining to safety reporting or Products and their related activities.
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. 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.