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.

Pharmacovigilance Agreement. ​ the Parties will execute a pharmacovigilance agreement ​ that will provide, among other things, ​ guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports and any other information as determined by the Parties. Such guidelines and procedures shall be in accordance with, and enable the Parties to comply with and fulfill, all Applicable Laws and all local and national regulatory reporting obligations to Regulatory Authorities and other Governmental Authorities.

Pharmacovigilance and Adverse Event Reporting. The Parties shall cooperate with regard to the reporting and handling of safety information involving the [[Unknown Identifier]] Co-Co Products in accordance with the Applicable Laws, regulatory requirements, and regulations on pharmacovigilance and clinical safety. The Lead Regulatory Party for a [[Unknown Identifier]] Co-Co Product in a given country shall be responsible for all processing of information related to any adverse events for such [[Unknown Identifier]] Co-Co Product for such country. Each Party shall provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a [[Unknown Identifier]] Co-Co Product within such time to ensure that all regulatory requirements and timelines are met in the respective Territories. No later than ​ prior to the first IND submission, unless mutually agreed in writing by the Parties, the Parties shall negotiate in good faith and enter into one or more (as appropriate) written Pharmacovigilance Agreements for the [[Unknown Identifier]] Co-Co Products, which agreements shall define the pharmacovigilance responsibilities of the Parties and include safety data exchange procedures governing the exchange of information affecting the [[Unknown Identifier]] Co-Co Products (e.g., serious adverse events, emerging safety issues) to enable each Party to comply with all of its legal and regulatory obligations related to such [[Unknown Identifier]] Co-Co Products (each a “Pharmacovigilance Agreement”). Between the execution of this Agreement and the execution of the Pharmacovigilance Agreement, each Party shall provide to the other Party within ​, any and all known information that may impact human safety with respect to the [[Unknown Identifier]] Research Program and [[Unknown Identifier]] Co-Co Products. Acadia shall own and maintain, and be responsible for, the global safety database for each [[Unknown Identifier]] Co-Co Product. In the event of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, the terms of this Agreement shall prevail and govern, except to the extent such conflicting terms relating directly to the pharmacovigilance responsibilities of the Parties (including the exchange of safety data), in which case the terms of the Pharmacovigilance Agreement shall prevail and govern.

Pharmacovigilance Within ​ after the Effective Date, the Parties shall enter into a pharmacovigilance agreement pursuant to which the Parties will mutually exchange adverse events or other safety data within and outside of the Territory as required for each Party to fulfill the relevant requirements in accordance with Applicable Law.

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 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.

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.

Safety Issues. The Parties will enter into a pharmacovigilance agreement (“Pharmacovigilance Agreement”), at a mutually agreed date, at least ​ days prior to ​. The Pharmacovigilance Agreement will govern the procedure for the mutual exchange of safety information within appropriate timeframes and in an appropriate format to enable the Parties to comply with any local and international regulatory reporting obligations and to facilitate appropriate safety reviews.

Pharmacovigilance. Not later than the date on which the first IND with respect to a Product is submitted to a Regulatory Authority, the Parties will discuss and enter into, as appropriate, a pharmacovigilance agreement on reasonable and customary terms that will provide, among other things, guidelines and responsibilities for # the receipt, investigation, recording, review, communication, reporting, and exchange between the Parties of Adverse Event reports and other safety information relating to the Products, # appropriate reconciliation procedures to ensure adequate and compliant exchange of safety data related to the Products, and # contact with Regulatory Authorities with respect to the foregoing, in each case ((a)-(c)), in accordance with Applicable Law (each, a “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement will contain terms no less stringent than those required by ICH Guidelines or other applicable guidelines in order to allow the Parties to meet the applicable regulatory and legal requirements regarding the management of safety data under Applicable Law throughout the Territory.