Common use of Adverse Event Reporting and Safety Data Exchange Clause in Contracts

Adverse Event Reporting and Safety Data Exchange. No later than [***] prior to the targeted filing date reasonably set by Licensee of an IND for any Product in the Field and in the Territory, the Parties shall enter into a commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include customary guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product, including any and all Safety Data. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for Products in the Territory to be maintained by Licensee [***]. Licensee shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. No later than [*** * *] prior to after the targeted filing date reasonably set by Licensee of an IND the first NDA for any Product in the Field Product, Catalyst or Catalyst’s sublicensee(s) (if applicable) and in the Territory, the Parties ISU shall enter into a commercially reasonable pharmacovigilance agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall include customary guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product, including any and all Safety Data. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on Harmonisation, except where such guidelines may conflict with existing local regulatory reporting or safety reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for Products in the Territory to be maintained by Licensee [***]Catalyst at its expense. Licensee Catalyst shall be responsible for reporting quality complaints, adverse events and safety data related to Products to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Products in the Territory. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. No later than [*****] prior to days after the targeted filing date reasonably set by Licensee of an IND for any Product in the Field and in the TerritoryEffective Date, the Parties shall enter into a commercially reasonable written pharmacovigilance agreement (the “Pharmacovigilance Agreement”)) for any products (including any Initial Products) containing SDX. The Pharmacovigilance Agreement These responsibilities shall include customary mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (exchange, as between the Parties) , of adverse event reports, pregnancy reports, and any other information concerning the safety of any Product, including any and all Safety Datasuch products. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant guidelines of the International Conference on HarmonisationICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting or safety reporting requirementsrequirement, in which case the local reporting requirements requirement shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event a global safety database for all products containing SDX, including any Initial Products in the Territory containing SDX, to be maintained by Licensee Company [*****]. Licensee As between the Parties, Company shall be responsible for preparing and filing with Regulatory Authorities in the Territory all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to such products in the Territory. KemPharm shall be responsible for reporting quality complaints, adverse events and safety data related to such Initial Products to applicable Regulatory Authorities Company for inclusion in the Territory, as well as responding to global safety issues and to all requests of Regulatory Authorities relating to Products in the Territorydatabase. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and permitted sublicensees licensees and Sublicensees, as applicable, to comply with such obligations.