Safety Information Exchange; Pharmacovigilance Agreement. (i) The Parties shall cooperate to develop methods and/or procedures for sharing information relating to the clinical experiences in accordance with safety reporting requirements of the respective Regulatory Authorities and as necessary for a Party to comply with Applicable Laws. Specific details regarding the management of safety information including adverse events reports related to the Development and the Commercialization of the Products will be delineated in a separate global pharmacovigilance agreement (the “PVA”) that shall be agreed to by the Parties as soon as reasonably practicable, but in any event not later than [***] of the Effective Date. The Lead Regulatory Party shall be responsible for the compliance and filing of all required safety reports to the Regulatory Authorities in the Territory, including annual safety reports, throughout the Term.
Appears in 4 contracts
Samples: Confidential Treatment Requested (Ultragenyx Pharmaceutical Inc.), Confidential Treatment Requested (Ultragenyx Pharmaceutical Inc.), Confidential Treatment Requested (Ultragenyx Pharmaceutical Inc.)
