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 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.