Common use of Adverse Events Reporting Clause in Contracts

Adverse Events Reporting. Promptly following the Effective Date and, in any event, as otherwise may be required to satisfy regulatory requirements, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Cytokinetics shall establish the global safety database for the Product, and shall maintain such global safety database for so long as such Product is under Development and/or Commercialization hereunder. The [*] shall be [*]. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Product in its territory to such database and to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Product, in each case [*] and to the extent required by the applicable Law. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

Adverse Events Reporting. Promptly following the Effective Date andDate, but in any event, as otherwise may be required to satisfy regulatory requirementsevent no later than the Initiation of any Clinical Trial of the Product in the Erasca Territory or the Joyo Territory, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable LawsApplicable Law. Cytokinetics Erasca shall establish and maintain the global safety database for the each Product throughout such Product’s lifecycle, and shall maintain such global safety database for so long as such Product is under Development and/or Commercialization hereunder. The [*] shall be [*]including Commercialization. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Product in its territory to such database and to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Product, in each case [*] at its own cost and to the extent required by the applicable Applicable Law. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees Affiliates and sublicensees to comply with such obligations.

Adverse Events Reporting. Promptly following the Effective Date and, in any event, as otherwise may be required to satisfy regulatory requirementsDate, the Parties shall will enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the ProductLicensed Products, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable LawsApplicable Law. Cytokinetics shall The Pharmacovigilance Agreement will provide that Climb will establish and maintain the global safety database for the each Licensed Product throughout such Licensed Product’s lifecycle, including Commercialization, and Mabworks shall maintain have access to such global safety database for so long as such Product is under Development and/or Commercialization hereunder. The [*] shall be [*]database. Each Party shall will hold the primary responsibility for reporting reporting, and will report, quality complaints, adverse events events, and safety data related to the Product Licensed Products in its territory Territory to such database and to the applicable Regulatory Authorities in its territoryTerritory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory Territory related to the ProductLicensed Products, in each case [*] and case, to the extent required by the applicable Applicable Law. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees Affiliates and sublicensees Sublicensees to comply with such obligations.