Clinical Safety Reporting; Pharmacovigilance. Prior to the Option Exercise Date, as between the Parties, Xencor shall be responsible for the timely reporting of all adverse drug events and safety data relating to the Compound and Products and similar matters to the appropriate Regulatory Authorities. Subsequent to the Option Exercise Date, as between the Parties, Amgen shall be responsible for the reporting of all new adverse drug events in compliance with the required timeframes in the Territory and safety data that arise or occur with respect to activities conducted by Amgen after such Option Exercise Date. Amgen shall also be responsible for the reporting of all new information related to previously reported adverse drug events by Xencor that are have not been resolved prior to the Option Exercise Date, other than such reporting required to be undertaken by Xencor under Applicable Law. In connection with the foregoing, upon request by either Party on or after the Option Exercise Date, the Parties shall promptly enter into a reasonable pharmacovigilance agreement concerning such operating procedures and related obligations to enable each Party to comply with Applicable Laws regarding adverse event and safety reporting.
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory Authority relating to any safety issue with respect to Licensed Products in the Field, Alcon shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) all such matters in accordance with applicable laws, rules and regulations. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws, rules and regulations. Such operating procedures and any material revisions to them shall be provided to the Coordination Committee for review and comment. The Parties agree to implement prior to the initiation of the first clinical trial for a Licensed Product in the Field, a separate agreement setting forth the responsibilities and procedures for clinical safety information exchange and reporting. In addition, the Parties agree to implement prior to the first launch of a Licensed Product in the Field, a separate agreement setting forth the pharmacovigilance responsibilities and procedures for safety information exchange and reporting. Such agreements shall include provisions requiring each Party promptly communicate to the other Party any correspondence related to the safety of Licensed Products in the Field to or from any Regulatory Authority. Such agreements shall also include coordination of reporting and correspondence related to safety matters with respect to products incorporating Development Compounds for applications outside of the Field. Without limiting the foregoing, the strategy and content of all responses to any questions from any such Regulatory Authority related to such matters received by either Party shall be subject to review and comment by the Coordination Committee (to the extent practical given the time-frames involved).
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory Authority relating to any safety issue with respect to Collaboration Products in the Field, Galderma shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) in the Galderma Territory and NovaBay shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) in the NovaBay Territory, in each case all in accordance with applicable Law and in close coordination with the other Party. Such operating procedures shall include any measures necessary for each Party to fully comply with such Laws and establish Galderma as responsible for establishing and maintaining the world-wide database for reporting for Collaboration Products in the Field. Such operating procedures and any material revisions to them shall be provided to the Coordination Committee for review and comment. The Parties agree to implement prior to the initiation of the first clinical trial for a Collaboration Product in the Field, a separate agreement setting forth the responsibilities and procedures for clinical safety information exchange and reporting. In addition, the Parties agree to implement prior to the first commercial sale of a Collaboration Product in the Field in the Galderma Territory or NovaBay Territory, a separate agreement setting forth the pharmacovigilance responsibilities and procedures for safety information exchange and reporting. Such agreements shall include provisions requiring each Party promptly communicate to the other Party any correspondence related to the safety of Collaboration Products in the Field to or from any Regulatory Authority. Such agreements shall also include coordination of reporting and correspondence related to safety matters with respect to products incorporating Multiple-Field Compounds for applications outside of the Field. Without limiting the foregoing, the strategy and content of all responses to any questions from any such Regulatory Authority related to such matters received by either Party shall be subject to review and comment by the Coordination Committee (to the extent practical given the time-frames involved).
Clinical Safety Reporting; Pharmacovigilance. Within ninety (90) days after the Effective Date, the Parties shall discuss in good faith and enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, and shall include customary terms and conditions governing safety data sharing, adverse events reporting and prescription events monitoring sufficient to permit Eagle, Cephalon, and their respective Affiliates and (sub)licensees to comply with their respective legal obligations, including in accordance with applicable Law inside and outside of the Territory (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement will provide for Cephalon’s support of Eagle with respect to such pharmacovigilance matters. Eagle will be solely responsible for establishing and will establish appropriate operating and other procedures reasonably sufficient to report to the appropriate Regulatory Authority(ies) all adverse event reports, safety reports and similar matters in accordance with the Pharmacovigilance Agreement.
Clinical Safety Reporting; Pharmacovigilance. The Parties agree that Coroando shall be responsible for the establishment of the global safety database for the Licensed Products in the Territory and the monitoring of all clinical experiences and submission of all required reports throughout clinical Development and Commercialization of the Licensed Products in the Territory, and that Licensor shall have primary responsibility for the monitoring of all clinical experiences and submission of all required reports concerning the Licensed Products outside the Territory. In each Party’s respective territory, such Party will be obligated, as part of their monitoring of all clinical experiences, to obtain follow-up information on any incomplete safety reports generated throughout the non-clinical and clinical Development and Commercialization of the Licensed Products. The Parties hereby agree to report to each other all Adverse Events and/or Serious Adverse Events with respect to the Licensed Products (whether occurring in any clinical trial conducted with regard to the Licensed Products or in connection with the commercialization of the Licensed Products in any country), within timeframes consistent with its reporting obligations under applicable Laws and in any event, if either Party is actively conducting a clinical trial under its own IND or commercializing the Licensed Products, then the other Party shall report such events no later than three (3) business days for Serious Adverse Event, and quarterly for Adverse Events, which report shall, in each case, include the circumstances and nature of such Serious Adverse Event or Adverse Event as required for reporting under applicable Laws. In addition, to the extent requested by either Party, the other Party shall promptly provide to the requesting Party any other information or materials that the requesting Party may require to provide to any Regulatory Authority with respect to any such Adverse Event or Serious Adverse Event. All disclosures made under this Section 4.5 shall be deemed Confidential Information of the disclosing Party; provided, that, the Party receiving such disclosures may, upon written notice to the disclosing Party, report the occurrence, circumstances and nature of such Adverse Event and/or Serious Adverse Event to any Regulatory Authority solely insofar as such reporting is required to comply with applicable Laws. For purposes of this section: “Adverse Event” means any untoward medical occurrence in a human clinical trial subject or in a...
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory
Clinical Safety Reporting; Pharmacovigilance. With respect to any Adverse Drug Reaction, safety reports under any Regulatory Filing or similar obligation to report to any Regulatory Authority relating to any Product safety issue, the Parties shall establish operating procedures to report to the appropriate Regulatory Authority(ies) all such matters in accordance with the Laws. Such operating procedures shall include any measures necessary for each Party to fully comply with such Laws. The Parties agree to implement prior to the Initiation of the first clinical trial for a Product, a separate agreement (with first draft to be provided by Astellas) setting forth (i) the responsibilities and procedures for clinical safety information exchange and reporting and (ii) the pharmacovigilance responsibilities and procedures for safety information exchange and reporting. Such agreements shall be updated from time to time as required by applicable Law or determined by the Parties and shall include provisions requiring each Party promptly communicate to the other Party any correspondence related to Product safety to or from any Regulatory Authority. The strategy and content of all responses to any questions from any such Regulatory Authority related to such matters received by either Party shall be subject to review and comment by the Parties, depending on the stage of Development or Commercialization of such Product (to the extent practical given the time-frames involved). For purposes of this Section 6.2.4, “Adverse Drug Reaction” has the meaning as defined in the then-current guidelines and regulations promulgated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and shall include any “Adverse Drug Experience” as defined in the then-current 21 CFR Sections 312.32 and 314.80.
Clinical Safety Reporting; Pharmacovigilance. The Parties shall establish reasonable processes and procedures for tracking, reporting, and otherwise addressing adverse events and reactions, safety issues, IND safety reports and similar obligation that each Party may have to any Regulatory Authority or otherwise under applicable law relating to any Collaboration Product. Such operating procedures and any material revisions to them, shall be reasonably coordinated between the Parties across jurisdictions.
Clinical Safety Reporting; Pharmacovigilance. At all times subsequent to the Amgen Option Effective Date, Amgen shall be solely responsible for establishing *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. and shall establish operating and other procedures reasonably sufficient to report to the appropriate Regulatory Authority(ies) all adverse event reports, safety reports and similar matters, unless otherwise determined by the JDC in accordance with the Laws in the Territory (and CK outside the Territory). Promptly following the Amgen Option Effective Date, the safety personnel of Amgen and CK will develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to Compounds (including with respect to pregnancies), product quality and product complaints involving adverse events with respect to Compounds, sufficient to permit each Party, its Affiliates and licensees to comply with their legal obligations, including to the extent applicable, those obligations contained in FDA regulations. Each Party shall further provide the other Party any assistance reasonably requested by the other Party in connection with safety reporting and fulfilling its obligations to Regulatory Authorities with respect thereto, and the requesting Party shall reimburse the other Party [***] costs incurred in connection therewith.
Clinical Safety Reporting; Pharmacovigilance
