Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. Within [***] after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for reporting quality complaints, Adverse Events, and safety data related to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Landos will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [***] after the Effective Date, the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible for reporting quality complaints, Adverse Events, and safety data related to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Landos Licensor will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos Licensor at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within [***] Subject to the terms of this Agreement, as needed, within three (3) months after the Effective Execution Date, or notification to the Pharmacovigilance Departments of the execution date, the Parties will negotiate in good faith (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall define and finalize the actions that responsibilities the Parties will shall employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (connection with the “Pharmacovigilance Agreement”)use of the Licensed Compound or Licensed Product. These responsibilities will shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports reports, pregnancy reports, and any other information concerning the safety of any Licensed Compound or Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and national international regulatory reporting obligations under applicable Lawto government authorities. Furthermore, such agreed procedure will procedures shall be consistent with relevant ICH International Council for Harmonization (ICH) guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will requirements shall prevail. Lian will be Until such guidelines and procedures are set forth in a written agreement between the Parties (hereafter referred to as the “Pharmacovigilance Agreement”), the party responsible for Pharmacovigilance prior to execution of this Agreement shall have sole Pharmacovigilance responsibility for the Licensed Compound or Licensed Product subject to all applicable regulations and guidelines. In the event that this Agreement is terminated, the Parties agree to implement the necessary procedures and practices to ensure that any outstanding pharmacovigilance reporting quality complaints, Adverse Eventsobligations are fulfilled. Any regulatory commitments relating to BMS’ prior development activities regarding the Licensed program in the Partner Territory prior to the Effective Date will remain the responsibility of BMS, and safety promptly after the Effective Date, BMS shall provide ZAI with pharmacovigilance data related that is set forth in the Pharmacovigilance Agreement for the Licensed Product(s) obtained prior to the Licensed Products in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Landos will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will comply with its respective obligations under such Pharmacovigilance Agreement and will cause its Affiliates and Sublicensees and contractors to comply with such obligationsEffective Date.

Pharmacovigilance. Within [***] after the Effective Date, the Parties Company and Licensee will negotiate in good faith and finalize the actions that the Parties Company and Licensee will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the PartiesCompany and Licensee) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties Company and Licensee to fulfill, local and national regulatory reporting obligations under applicable LawLaws. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian Licensee will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to the Licensed Products Product in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory; provided that Licensee will conduct such activities (1) in its own name, if Licensee is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Field in the Territory or (2) as the express and authorized regulatory agent of record for Company in the Field in the Territory, if Company is the legal and beneficial owner of the Regulatory Approvals for the Licensed Products in the Territory, under which situation such actions will be taken on behalf of Company and for the benefit of Licensee in the Field in the Territory. Landos Company will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to Licensed Product to applicable Regulatory Authorities outside the Field in the Territory and outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Field in the Territory and outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos Company at its sole cost and expense, to which Licensee shall contribute data in such form and format, and on such other terms, as provided in the Pharmacovigilance Agreement and which worldwide safety database will be accessible by Lian and Licensee, its Affiliates, Sublicensees and contractors to the full extent necessary for Lian Licensee to exercise its rights under this Agreement, comply with its obligations under this Agreement Agreement, and comply with all applicable LawLaws. Each Party will of Company and Licensee hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and will to cause its Affiliates and Sublicensees its and their sublicensees and contractors to comply with such obligations.

Pharmacovigilance. Within No later than [***] after days following the Effective Date, but in any event [***], the Parties will negotiate in good faith and finalize shall enter into a pharmacovigilance agreement setting forth the actions that worldwide pharmacovigilance procedures for the Parties will employ with respect to the Licensed Products to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities , which agreement will include mutually acceptable guidelines provide for coordination and procedures for sharing of relevant safety information related to the receipt, investigation, recordation, communication, and exchange (as Licensed Products between the Parties) Parties in order to facilitate prompt filing of Adverse Event accurate and consistent reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be to Regulatory Authorities in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable compliance with Applicable Law. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian will be responsible Each Party shall hold the primary responsibility for reporting quality complaints, Adverse Events, adverse events and other safety data related to the Licensed Products in its territory to the Field to applicable Regulatory Authorities in the Territoryits territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating in its territory related to the Licensed Products, in each case, at its own cost and to the extent required by Applicable Laws. ReViral shall be responsible for the establishment and maintenance of a global safety database at its own cost and expense. Licensee may, at its own cost and expense, establish and maintain its own local safety database to store the safety information generated from the Development of the Licensed Products in the Field Territory, and to assure regulatory reporting compliance in the Territory. Landos will be responsible for reporting quality complaints, Adverse Events, and safety data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos at its sole cost and expense, which worldwide safety database will be accessible by Lian and its Affiliates, Sublicensees and contractors to the full extent necessary for Lian to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Law. Each Party will agrees to comply with its respective obligations under such the Pharmacovigilance Agreement and will to cause its Affiliates Affiliates, licensees and Sublicensees and contractors to comply with such obligations. Each Party will notify the other Party of any new planned Clinical Trials for any Licensed Product and the Parties will update the Pharmacovigilance Agreement to the extent necessary to comply with any applicable requirements set forth under Applicable Law or of any Regulatory Authorities related to adverse event reporting, drug safety, patient safety, pharmacovigilance, and risk management. Notwithstanding anything to the contrary in this Agreement or the Pharmacovigilance Agreement, each Party and its Affiliates, licensees, and Sublicensees will have the right to disclose information related to the safety of the Compounds or Licensed Products to the extent that such disclosure is required for such Party to comply with its obligations under Applicable Law or the safety requirements of the applicable Regulatory Authorities. To the extent that there is a conflict between the terms of this Agreement and the terms of the Pharmacovigilance Agreement, the terms of the Pharmacovigilance Agreement will govern with respect to the subject matter set forth therein.

Pharmacovigilance. Within [***] after the Effective Date], the Parties will negotiate in good faith and finalize the actions that the Parties will employ with respect to the Licensed Products Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable LawLaws. Furthermore, such agreed procedure will be consistent with relevant ICH guidelines, except where such said guidelines may conflict with existing local regulatory reporting safety reporting requirements, in which case local reporting requirement will prevail. Lian Licensee will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to the Licensed Products Product in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Landos Company will be responsible for reporting quality complaints, Adverse Events, Events and safety data related to Licensed Product to applicable Regulatory Authorities outside the TerritoryTerritory or outside the Field, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the TerritoryTerritory or outside the Field. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Landos Company at its sole cost and expense, which worldwide safety database will be accessible by Lian and Licensee, its Affiliates, Sublicensees and contractors to the full extent necessary for Lian Licensee to exercise its rights under this Agreement, comply with its obligations under this Agreement Agreement, and comply with all applicable LawLaws. Each Party will hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and will to cause its Affiliates Affiliates, Affiliated Entities (to the extent applicable) and Sublicensees permitted sublicensees and contractors to comply with such obligations.