Adverse Event Reporting; Pharmacovigilance Agreement. ​ 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 event 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. Ovid has established, and shall continue to hold (either by itself or through a vendor engaged by Ovid) 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 envision that Ovid will separately maintain the Product global safety database and Licensee will maintain its own Product safety database with respect to the Licensee Territory and the Parties will synchronize the Product databases in accordance with the Pharmacovigilance Agreement so that they each maintain all Product safety data; however, the Parties agree that the Ovid global safety database will be the source for all periodic reports. Ovid shall ​ from its database and Licensee will maintain ​ its own Product safety database. The CGB shall establish a safety subcommittee to draft the Pharmacovigilance Agreement to define the process for exchanging adverse event reports using the Ovid global safety database, as well as periodic reports, regulatory communication, and other key elements. The Parties will collaboratively agree on data cut points for periodic safety reports and Ovid will review and approve all such reports. The Parties will jointly review and approve such reports before submission to Regulatory Authorities in the Licensee Territory as required. Such safety subcommittee shall implement the Pharmacovigilance Agreement and coordinate with respect to any Safety Data reporting for the Products to the Regulatory Authorities in the Licensee Territory including, responding to safety issues, communicating with Regulatory Authorities related to the Products under any MAA or Regulatory Approval for the Product held by such Party and filed with such Regulatory Authorities, including maintaining the qualified person for Pharmacovigilance and individual case safety report processing, 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 Sublicensees to comply with such obligations.

Adverse Event Reporting and Safety Data Exchange. No later than ​ before the Initiation of a Clinical Trial with respect to the Development of any Licensed Product in the [[3D Medicines:Organization]] Territory, the Parties shall define and finalize the actions that the Parties shall employ with respect to such Licensed Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) for the Development of the Licensed Product globally. Further, no later than ​ before the anticipated launch date of any Licensed Product in the [[3D Medicines:Organization]] Territory, the Parties shall enter into a separate Pharmacovigilance Agreement for the Commercialization of the Licensed Product. Each of the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Licensed Product, and other routine pharmacovigilance reporting requirements. 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 ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for the Licensed Products in the Field in the [[3D Medicines:Organization]] Territory to be maintained by [[3D Medicines:Organization]] at [[3D Medicines:Organization]]’ expense, and a global safety database for the Licensed Products to be maintained by [[Aravive:Organization]] at [[Aravive:Organization]]’s expense. As between the Parties, [[3D Medicines:Organization]] shall be responsible for preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Field in the [[3D Medicines:Organization]] Territory, and [[3D Medicines:Organization]] shall be responsible for filing such reports and responses with Regulatory Authorities in the [[3D Medicines:Organization]] Territory. As between the Parties, [[3D Medicines:Organization]] shall also be responsible for reporting any quality complaints, adverse events and safety data related to Licensed Products in the Field in the [[3D Medicines:Organization]] Territory to [[Aravive:Organization]] for inclusion in the global safety database. 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 Events Reporting; Quality. At least ​ prior to the expected initiation of the first Clinical Trial under this Agreement, 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:Organization]] shall establish and maintain the global safety database for the Product and conduct overall signal detection and benefit risk evaluation of the Product. 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 Laws. [[Cytokinetics:Organization]] agrees to support Ji Xing on safety issues or safety request related to the Product when output from global safety database is required. At least ​ prior to the expected initiation of the first Clinical Trial under this Agreement, the Parties shall enter into a clinical quality agreement for the Territory (the “Clinical Quality Agreement”). Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and Clinical Quality Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

Pharmacovigilance. At least ​ (​) ​ prior to the First Commercial Sale for any Licensed Product (​), the Parties shall define and finalize the actions that the Parties shall employ with respect to such Licensed Product (​) to protect patients and promote their well‑being in a written pharmacovigilance agreement (Pharmacovigilance Agreement), with Bioeq as the global safety database holder. These responsibilities set forth in the Pharmacovigilance Agreement shall 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 the Licensed Products (​). Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfil, local and national regulatory reporting obligations under Applicable Law and regulations. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates to comply with such obligations. Bioeq will maintain its global safety databases pursuant to its own policies and as necessary to comply with Applicable Law governing adverse experiences.

Pharmacovigilance. No later than ​ prior to # ​ or # ​, 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. Lyra 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 Lyra 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 and Adverse Event Reporting. The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in accordance with the Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. For each Licensed Product, GSK will be responsible for all processing of information related to any adverse events for such Licensed Product. Each Party will provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a Licensed Product in a timely manner. The drug safety departments from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information and timelines within ​ days of the Effective Date, which pharmacovigilance agreement will provide for the transfer of ITEOS’s then-current safety database for Licensed Products to GSK, including the timing for such transfer. Such written pharmacovigilance agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its Sublicensees or designees) to comply with all Applicable Laws. GSK will own and maintain the global safety database for all Licensed Products.

Pharmacovigilance and Adverse Event Reporting. The Parties shall execute, within ​, a separate pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to specify details of the Parties’ obligations with respect to reporting any adverse events associated with any Product, exchanging adverse event and other safety information relating to the Products, and any other pharmacovigilance obligations.

Promptly following the Effective Date, but in no event later than ​ days thereafter, Zai and TPTX shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Pharmacovigilance Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Pharmacovigilance Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.9, Section 6.10, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.

Adverse Events Reporting. Promptly following the Effective Date, but in no event later than ​ thereafter, Alexion and Eidos shall develop and agree in a written agreement to worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to Licensed Products and sufficient to permit each Party and its Affiliates, Third Party Licensees and Sublicensees to comply with its legal obligations with respect thereto. The Pharmacovigilance Agreement shall be promptly updated if required by changes in Applicable Law. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, Third Party Licensees and Sublicensees to comply with such obligations. Without limiting the foregoing, Eidos will be responsible for maintaining a global adverse event database for all Clinical Trials conducted in the Territory and the ROW Territory, ​.