PV Agreement. If requested by Bayer the Parties will enter into an Agreement setting forth the specific procedures to be used by the Parties to coordinate the investigation and exchange of reports of adverse drug experiences and product complaints with respect to Licensed GT Products to ensure timely communication to Regulatory Authorities and compliance with Laws.
PV Agreement. Not later than *** after the Effective Date, the Parties shall use commercially reasonable efforts to enter into a separate pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse drug reactions, adverse events, medical inquires with safety concerns, and other relevant drug safety matters with respect to Products during the Term.
PV Agreement. Prior to initiation by SymBio of any clinical trial of Product, the Parties shall negotiate in good faith and enter into a pharmacovigilance/safety data exchange agreement for Products (the “PV Agreement”), which shall set forth standard operating procedures governing the collection, investigation, reporting, and exchange of information concerning adverse drug reactions or experiences sufficient to permit each Party to comply with its regulatory and other legal obligations within the applicable timeframes. The PV Agreement’s terms and conditions shall be no less stringent than U.S., Japan and ICH guidelines, such that each Party shall be able to comply with all regulatory and legal requirements regarding the management of safety data by providing for the exchange of relevant information in appropriate format within applicable timeframes. Subject to the foregoing, each Party shall be responsible for monitoring all clinical experiences with respect to Product in the course of its own Product development activities and filing all required reports with respect thereto in its respective field (i.e., with respect to SymBio, in the Field, and with respect to Chimerix, in the Excluded Indication).
PV Agreement. Immix, as the sponsor of the Study, shall be, as between the Parties, responsible, with BeiGene’s reasonable assistance, for compliance with the applicable laws and regulations pertaining to safety reporting and related activities. All serious adverse event (“SAE”) reports arising from any aspect of the Study where a patient has been exposed to the BeiGene Product and/or Immix Compound shall be handled in accordance with the terms of a pharmacovigilance agreement (“PV Agreement”) to be executed by the Parties within ninety (90) days of the Effective Date. The PV Agreement shall include safety data exchange procedures governing 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 BeiGene Product and/or the Immix Compound in the Study, and any other safety information arising from nonclinical or other clinical studies with the BeiGene Product and/or the Immix Compound, consistent with applicable law, rules and regulations. In the event of any inconsistency between this Agreement and the PV Agreement pertaining to pharmacovigilance matters, the PV Agreement shall control and in all other circumstances this Agreement shall control. For clarity, where an issue is addressed in either this Agreement or the PV Agreement and not addressed in the other, there is no inconsistency.
PV Agreement. Not later than *** after the Effective Date, the Parties shall use *** to enter into a separate pharmacovigilance agreement (the “PV Agreement”) containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse drug reactions, adverse events, medical inquires with safety concerns, and other relevant drug safety matters with respect to Products during the Term. Menarini acknowledges that its obligations under the PV Agreement shall include collecting and monitoring adverse events in the Menarini Territory and providing VIVUS with information on such adverse events in a format and on a timeline specified in the PV Agreement, which format shall be consistent with regulatory obligations under Applicable Law (including any obligations imposed on VIVUS or Menarini, as the case may be, as the holder of the Product Marketing Authorization). Any failure to comply with the PV Agreement by Menarini in any material respect shall be deemed to be a material breach of this Agreement, giving rise to VIVUS’s right to terminate this Agreement pursuant to Section 12.2(a).
PV Agreement. The Parties agree that the PV Agreement solely as it applies (or would apply) to Program Compounds and Products for the PD-1/VISTA Licensed Program is hereby terminated as of the Fourth Amendment Date.
PV Agreement. Within *** of the Effective Date, the Parties shall use commercially reasonable efforts to enter into a separate pharmacovigilance agreement (the “PV Agreement”), containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse drug reactions, adverse events, medical inquires with safety concerns, and other relevant drug safety matters with respect to Products during the Term. From the Effective Date until the date that the Parties have entered into the PV Agreement, but in no event for any period longer than *** following the Effective Date, VIVUS shall handle medical inquiries, complaints and adverse experience reporting for the Product in the United States in accordance with VIVUS’ customary practice for handing such activities and using VIVUS’ existing resources (including call centers).
PV Agreement. Within thirty (30) days of the Effective Date, the Parties shall use commercially reasonable efforts to enter into a separate pharmacovigilance agreement (the “PV Agreement”), containing the specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse drug reactions, adverse events, medical inquires with safety concerns, and other relevant drug safety matters with respect to Products during the Term. From the Effective Date until the date that the Parties have entered into the PV Agreement, but in no event for any period longer than thirty (30) days following the Effective Date, VIVUS shall handle medical inquiries, complaints and adverse experience reporting for the Product in the United States in accordance with VIVUS’ customary practice for handing such activities and using VIVUS’ existing resources (including call centers).
PV Agreement. Within [***] days of the Effective Date, the Parties shall agree in good faith and execute a pharmacovigilance agreement to govern the exchange of safety data with respect to the PM8002 Licensed Compound and PM8002 Licensed Product. Following the PM8003 Option Exercise Date or the Preclinical Multispecific Option Exercise Date, if BioNTech determines that a pharmacovigilance agreement should be executed between the Parties to govern the exchange of safety data with respect to the PM8003 Licensed Compound and PM8003 Licensed Product or a Preclinical Multispecific Licensed Compound and Preclinical Multispecific Licensed Product as applicable, BioNTech will notify Biotheus and the Parties shall agree in good faith and execute such agreement within [***] days following such notification.
PV Agreement. The Parties shall enter into a Pharmacovigilance Agreement, within [***] days following the Effective Date or such other period as agreed by the Parties.
