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. As between the Parties: (a) Aptose shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to Licensed Compounds and Products to the appropriate Regulatory Authorities in the Licensed Territory; and (b) CG shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Safety Data relating to Licensed Compounds and Products to the appropriate Regulatory Authorities in the Retained Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. Prior to Aptose’s first filing of an IND for a Product, 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 Licensed Compounds and Products worldwide within appropriate timeframes and in an appropriate format to enable each Party to meet both expedited and periodic regulatory reporting requirements; (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; and (iii) providing for a global safety database to be established and maintained by Aptose at its cost.
Adverse Event Reporting; Pharmacovigilance Agreement. Within sixty (60) days after the Effective Date, but in any case prior to transfer of the marketing authorization, the Parties shall enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the 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 [ * ] 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 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and national regulatory reporting obligations under Applicable Laws (including to the extent applicable, those obligations contained in ICH guidelines, E2A, X0X, X0X, X0X and E2F) to monitor the patients’ safety. Exelixis has established and shall continue to hold at its costs and expenses the global safety database for the Products, and shall maintain such global safety database for so long as such Product is under Development and/or Commercialization by the Parties. The Parties will collaboratively agree on data cut points for periodic aggregate safety reports and Exelixis will author such reports; the Parties will jointly review and approve such reports before submission to worldwide Regulatory Authorities as required. Exelixis shall bear one hundred percent (100%) of the cost and expense for establishing and maintaining such global database and the preparation of periodic aggregate safety reports (“PV Costs”) from the Effective Date through [ * ]. After such date, and subject to Section 4.5(a), Exelixis shall bear [ * ] percent ([ * ]%) and Licensee shall bear [ * ] percent ([ * ]%) of PV Costs. Exelixis will ensure that each Party and any Future Exelixis Licensee are able to access the data, if necessary indirectly, from the global safety database in order to meet legal and regulatory obligations. The Parties agree that Exelixis shall not transfer the responsibility or holding of the global safety database to any CRO, sublicensee, Future Exelixis Licensee or any Third Party without Licensee’s prior written consent and approval, which shall not be unreasonably withheld, conditi...
Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) Neurocrine shall be responsible for the timely reporting of all quality, complaints and Safety Data relating to Compounds and Products to the appropriate Regulatory Authorities outside the MTPC Territory; and (b) except as otherwise agreed in writing by the Parties, MTPC shall be responsible for the timely reporting of all quality, complaints and Safety Data relating to Compounds and Products to the relevant Regulatory Authorities in the MTPC Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and each Party shall be solely responsible for costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. The Parties shall negotiate in good faith and enter into, in timely manner, a mutually acceptable pharmacovigilance agreement with respect to the Compound and Product. Unless otherwise mutually agreed, such pharmacovigilance agreement shall cover the exchange of safety information and appropriate management of pharmacovigilance activities to fulfill all legal and regulatory requirements both inside and outside of the MTPC Territory.
Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) HanAll shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Licensed Product quality, Licensed Product complaints and Safety Data
Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) XOMA shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Products (including the XOMA Antibodies and Zydus IL-2 contained therein) to the appropriate Regulatory Authorities in the XOMA Territory; and (b) Zydus shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, product quality, product complaints and Safety Data relating to Products (including the XOMA Antibodies and Zydus IL-2 contained therein) to -22 of 63- [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed.
Adverse Event Reporting; Pharmacovigilance Agreement. CytoDyn shall be responsible for all adverse event reporting, including any and all Serious Adverse Events with respect to all Licensed Products for all indications in the Territory. CytoDyn shall maintain the unified worldwide adverse event database for the Licensed Products. Within ninety (90) days of the Effective Date the Parties will enter into the Pharmacovigilance Agreement, setting forth guidelines and procedures for the receipt, investigation, recording, review, post-marketing surveillance, communication, reporting and exchange between the Parties of adverse event reports, technical complaints and any other information concerning the safety of the Licensed Products. Vyera shall be responsible for promptly (and in any event in sufficient time to permit CytoDyn to comply with its legal and regulatory reporting obligations) providing to CytoDyn any and all information relating to adverse events, including, without limitation, Serious Adverse Events, that comes into its possession.
Adverse Event Reporting; Pharmacovigilance Agreement. As between the Parties: (a) ARS shall be responsible for the timely reporting of all quality issues, complaints and Safety Data relating to Products to the appropriate Regulatory Authorities outside the ALFRESA Territory and shall timely report to ALFRESA the content of the report made to the Regulatory Authorities; and (b) except as otherwise agreed in writing by the Parties, ALFRESA shall be responsible for the timely reporting of all quality issues, complaints and Safety Data relating to Products to the relevant Regulatory Authorities in the ALFRESA Territory, in each case in accordance with Applicable Laws of the relevant countries and Regulatory Authorities. The Parties shall cooperate with each other with respect to their respective pharmacovigilance responsibilities, and each Party shall be solely responsible for its costs relating to its respective pharmacovigilance responsibilities, unless agreed otherwise by the Parties in writing. The Parties shall negotiate in good faith and enter into, in timely manner, a mutually acceptable pharmacovigilance agreement with respect to the Products. Until such pharmacovigilance agreement is established, ARS shall report quality issues, complaints and Safety Data relating to clinical trials in the ALFRESA Territory up until the submission of the application to regulatory authorities in the ALFRESA Territory. Unless otherwise mutually agreed, such pharmacovigilance agreement shall cover the exchange of safety information and appropriate management of pharmacovigilance activities to fulfill all legal and regulatory requirements both inside and outside of the ALFRESA Territory.
Adverse Event Reporting; Pharmacovigilance Agreement. As soon as reasonably practicable after the Effective Date, the Parties shall enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the 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 [*] 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. Rigel has established, and shall continue to hold (either by itself or through a vendor engaged by Rigel) the global safety database for the Products, and shall maintain such global safety database for so long as such Product is under Development or Commercialization by the Parties. The Parties will collaboratively agree on data cut points for periodic aggregate safety reports and Rigel will author such reports; the Parties will jointly review and approve such reports before submission to worldwide Regulatory Authorities as required. Rigel shall [*] such database and preparing such reports. Kissei shall maintain its own safety database for the Product in the Kissei Territory and shall provide all Safety Data, including adverse event reports, in such database to Rigel in accordance with this Section 5.4 and the Pharmacovigilance Agreement. Kissei shall [*] such database for the Kissei Territory and preparing reports in the Kissei Territory. Rigel will ensure that each Party is able to access the data from the global safety database in order to meet legal and regulatory obligations. The JSC shall establish a safety subcommittee, and all Safety Data, including adverse event reports, shall be submitted to such safety subcommittee and Rigel concurrently so that Rigel may update the global safety database accordingly. Such safety subcommittee shall coordinate with respect to any Safety Data reporting for the Products to the Regulatory Authorities in the Kissei Territory, but each Party shall be primarily responsible for reporting quality complaints, adverse events, and Safety Data related to the Products to any necessary Regulatory Authorities, and responding to safety issues and to all requests of Regula...
Adverse Event Reporting; Pharmacovigilance Agreement
