Common use of Adverse Event Reporting; Pharmacovigilance Agreement Clause in Contracts

Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) Cue shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the Cue Territory; and (b) LGC shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the LGC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Cue shall be responsible for preparing, reporting and maintaining global pharmacovigilance system and the core safety data sheet. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each Party shall be solely responsible for all costs it incurs to conduct its respective pharmacovigilance responsibilities. Within one hundred eighty (180) days after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to Collaboration Compounds and Collaboration Products worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data.

Adverse Event Reporting; Pharmacovigilance Agreement. Fosun acknowledges that Palatin has agreed with AMAG Pharmaceuticals, Inc., (“AMAG”) Palatin’s exclusive licensee for North America, that AMAG shall be solely responsible for maintaining the global safety database for Products. Fosun agrees to negotiate in good faith and enter into such pharmacovigilance agreements as are reasonably necessary in further of AMAG maintaining the global safety database for Products. […***…]. As between the Parties: (a) Cue Fosun shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, product Product quality, product Product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in the Cue Territory; and (b) LGC AMAG and Palatin shall be responsible for the pharmacovigilance surveillance and timely reporting of all relevant adverse drug reactions/experiences, product Product quality, product Product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products any Compound, Product, Pharmaceutical Product or Product Delivery Device to the appropriate Regulatory Authorities in outside the LGC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Cue shall be responsible for preparing, reporting and maintaining global pharmacovigilance system and the core safety data sheetapplicable Laws. The Parties shall cooperate with each other and with AMAG with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each each Party shall be solely responsible for all costs it incurs relating to conduct its respective pharmacovigilance responsibilities. Within one hundred eighty (180) days after , except to the Effective Date, extent agreed otherwise by the Parties in writing. […***…], Fosun and AMAG (or, at Palatin’s option, Fosun, Palatin and AMAG) shall enter into a pharmacovigilance agreement agreement, pursuant to which AMAG will maintain the global safety database for Products, on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to Collaboration Compounds all Compounds, Products, Pharmaceutical Products and Collaboration Products Product Delivery Devices worldwide within appropriate timeframes and in an appropriate format to enable each Party Party, as applicable, and AMAG to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.

Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) Cue [***] shall be responsible for the timely reporting of all relevant adverse drug reactions/experiencesquality issues, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in outside the Cue TerritoryPediatrix Territory and shall timely report to [***] the content of the report made to the Regulatory Authorities; and (b) LGC except as otherwise agreed in writing by the Parties, [***] shall be responsible for the timely reporting of all relevant adverse drug reactions/experiencesquality issues, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate relevant Regulatory Authorities in the LGC Pediatrix Territory, in each case in accordance with Applicable Laws of the relevant countries or jurisdictions and Regulatory Authorities. Cue In addition, [***] shall be responsible for preparingresponding to technical and medical questions from all sources in the Pediatrix Territory relating to the use and functioning of the Products, reporting and maintaining global pharmacovigilance system shall also serve as the batch release, product defect and recall contact in the core safety data sheetPediatrix Territory, for which [***] shall provide reasonably necessary assistance. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each each Party shall be solely responsible for all its costs it incurs relating to conduct its respective pharmacovigilance responsibilities. Within one hundred eighty (180) days after the Effective Date, the The Parties shall negotiate in good faith and enter into into, in timely manner, a mutually acceptable pharmacovigilance agreement on terms that comply with ICH guidelinesrespect to the Products, including: (i) providing detailed procedures regarding pursuant to which ARS shall hold and control the maintenance of core global safety information database for the Products. Until such pharmacovigilance agreement is established, [***] shall report quality issues, complaints and the exchange of Safety Data relating to Collaboration Compounds and Collaboration Products worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated clinical trials in the ICH guidelinesPediatrix Territory up until the submission of the application to regulatory authorities in the Pediatrix Territory. Unless otherwise mutually agreed, such pharmacovigilance agreement shall cover the exchange of safety information and all applicable regulatory and legal requirements regarding the appropriate management of Safety Datapharmacovigilance activities to fulfill all legal and regulatory requirements both inside and outside of the Pediatrix Territory.

Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) Cue shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the Cue Territory; and (b) LGC shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the LGC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Cue shall be responsible for preparing, reporting and maintaining global pharmacovigilance system and the core safety data sheet. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each Party shall be solely responsible for all costs it incurs to conduct its respective pharmacovigilance responsibilities. Within one hundred eighty (180) days As soon as reasonably practicable after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that setting forth the pharmacovigilance procedures for the Parties with respect to the Product, such as Safety Data sharing, adverse events reporting, and safety signal and risk management (the “Pharmacovigilance Agreement”), which agreement shall be amended by the Parties [ * ] to comply with any changes in Applicable Laws or any guidance received from Regulatory Authorities. Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws (including, to the extent applicable, those obligations contained in ICH guidelines) to monitor patients’ safety. (b) Rigel has established, including: and shall continue to hold (ieither by itself or through a vendor engaged by Rigel) providing detailed procedures regarding the maintenance of core global safety information database for the Product, and shall maintain such global safety database for so long as such Product is under Development or Commercialization by the exchange of Safety Data relating to Collaboration Compounds Parties. Rigel shall [ * ] such database and Collaboration Products worldwide within appropriate timeframes and in an appropriate format to enable preparing such reports. Rigel will ensure that each Party is able to access the data from the global safety database in order to meet both expedited legal and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis obligations. Grifols shall maintain its own safety database for the reporting of Product in the Grifols Territory and shall provide all Safety Data Data, including adverse event reports, in such database to Rigel in accordance with standards stipulated in this Section ‎5.4 and the ICH guidelinesPharmacovigilance Agreement. Grifols shall [ * ] such database for the Grifols Territory and preparing reports for the Grifols Territory. (c) Each Party shall be primarily responsible for reporting quality complaints, adverse events, and Safety Data related to the Product to any necessary Regulatory Authorities, and responding to safety issues and to all applicable regulatory requests of Regulatory Authorities related to the Product under any MAA or Regulatory Approval for the Product held by such Party and legal requirements regarding filed with such Regulatory Authorities, [ * ]. Each Party agrees to comply with its respective obligations under the management of Safety DataPharmacovigilance Agreement and to cause its Affiliates, licensees, and sublicensees to comply with such obligations.

Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) Cue shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products A reasonable time prior to the appropriate Regulatory Authorities initiation of any Development work in the Cue Beijing SL Territory; and (b) LGC shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the LGC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Cue shall be responsible for preparing, reporting and maintaining global pharmacovigilance system and the core safety data sheet. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each Party shall be solely responsible for all costs it incurs to conduct its respective pharmacovigilance responsibilities. Within one hundred eighty (180) days after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as Safety Data sharing, adverse events reporting, and safety signal and risk management (the “Pharmacovigilance Agreement”), which agreement shall be amended by the Parties from time to time as necessary to comply with any changes in Applicable Laws or any guidance received from Regulatory Authorities. Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws (including, to the extent applicable, those obligations contained in ICH guidelines) to monitor patients’ safety. Gemphire shall maintain (either by itself or through a vendor engaged by Gemphire) the global safety database in English for the Licensed Products, including: (i) providing detailed procedures regarding and shall maintain such global safety database for so long as such Licensed Product is under Development or Commercialization by the maintenance of core Parties. The Parties will collaboratively agree on data cut points for periodic aggregate safety information reports and Gemphire will author such reports; the exchange of Parties will jointly review and approve such reports before submission to worldwide Regulatory Authorities as required. Each Party shall bear their own costs associated with maintaining such database and preparing such reports. Gemphire shall ensure that Beijing SL is able to access the data from the global safety database in order to meet legal and regulatory obligations. Beijing SL shall be responsible for reporting to Gemphire in English all quality complaints, adverse events, and Safety Data relating related to Collaboration Compounds and Collaboration the Licensed Products worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable any Regulatory Authorities on a worldwide basis in the Beijing SL Territory, and responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products under any MAA or Regulatory Approval for the reporting of Safety Data in accordance Licensed Product held by Beijing SL and filed with standards stipulated such Regulatory Authorities in the ICH guidelinesBeijing SL Territory, in each case at its own cost. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees, and all applicable regulatory and legal requirements regarding the management of Safety Datasublicensees to comply with such obligations.

Adverse Event Reporting; Pharmacovigilance Agreement. Endoceutics shall be solely responsible for maintaining the global safety database for the Product [***]. [***] and provide any and all safety information to Endoceutics for it to meet its obligations of keeping the global safety database for the Product as set forth in the previous sentence. As between the Parties: (a) Cue Endoceutics shall be responsible for the pharmacovigilance surveillance, timely reporting of all relevant adverse drug reactions/experiences, product Product quality, product Product complaints and Safety Data relating to Collaboration Compounds the Compound and Collaboration Products the Product to the appropriate Regulatory Authorities in outside the Cue Territory; and (b) LGC except as otherwise agreed in writing by the Parties, AMAG shall be responsible for the pharmacovigilance surveillance, timely reporting of all relevant adverse drug reactions/experiences, product Product quality, product Product complaints and Safety Data relating to Collaboration Compounds the Compound and Collaboration Products the Product in the Field to the appropriate Regulatory Authorities in the LGC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Cue shall be responsible for preparing, reporting and maintaining global pharmacovigilance system and the core safety data sheet. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each each Party shall be solely responsible for all costs it incurs relating to conduct its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. Within one hundred eighty (180) days [***] after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that comply with ICH guidelines, including: (i) providing detailed procedures regarding the maintenance of core safety information and the exchange of Safety Data relating to Collaboration Compounds the Compound and Collaboration Products the Product worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis for the reporting of Safety Data in accordance with standards stipulated in the ICH guidelines, and all applicable regulatory and legal requirements regarding the management of Safety Data.

Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) Cue shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the Cue Territory; and (b) LGC shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Collaboration Compounds and Collaboration Products to the appropriate Regulatory Authorities in the LGC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. Cue shall be responsible for preparing, reporting and maintaining global pharmacovigilance system and the core safety data sheet. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and LGC shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the Cue Territory and Cue shall comply with all pharmacovigilance requirements necessary to support Development and Commercialization of Collaboration Products in the LGC Territory. Each Party shall be solely responsible for all costs it incurs to conduct its respective pharmacovigilance responsibilities. Within one hundred eighty (180) days soon as reasonably practicable after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on terms that setting forth the pharmacovigilance procedures for the Parties with respect to the Drug Candidate and Product, such as Safety Data sharing, adverse events reporting, and safety signal and risk management (the “Pharmacovigilance Agreement”), which agreement shall be amended by the Parties from time to time as necessary to comply with any changes in Applicable Laws or any guidance received from Regulatory Authorities. Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws (including, to the extent applicable, those obligations contained in ICH guidelines) to monitor patients’ safety. Viracta has established, including: and shall continue to hold (i) providing detailed procedures regarding the maintenance of core either by itself or through a vendor engaged by Viracta), a global safety information and the exchange of Safety Data relating to Collaboration Compounds and Collaboration Products worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; and (ii) ensuring compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis database for the reporting of Drug Candidate and Products, and shall maintain such global safety database for so long as the Drug Candidate is under Development or Commercialization by the Parties. Viracta shall bear the costs associated with maintaining such database and preparing reports for outside the Territory. Salubris shall maintain, and bear the costs associated with maintaining, its own safety database for the Drug Candidate and Products in the Territory and shall provide all Safety Data Data, including adverse event reports, in such database to Viracta in accordance with standards stipulated the Pharmacovigilance Agreement. Viracta shall ensure that each Party is able to access the data from the global safety database in the ICH guidelinesorder to meet legal and regulatory obligations. Each Party shall be primarily responsible for reporting quality complaints, adverse events, and Safety Data related to the Drug Candidate and Product to any necessary Regulatory Authorities in its territory, and responding to safety issues and to all applicable regulatory requests of Regulatory Authorities related to the Drug Candidate and legal requirements regarding Product, in each case at its own cost. Each Party agrees to comply with its respective obligations under the management of Safety DataPharmacovigilance Agreement and to cause its Affiliates, licensees, and sublicensees to comply with such obligations.