Safety Event Reporting Clause Samples
The Safety Event Reporting clause requires parties to promptly document and communicate any incidents or adverse events that may impact the safety of individuals involved in a project or activity. Typically, this involves establishing clear procedures for identifying, recording, and notifying relevant stakeholders or authorities about safety-related occurrences, such as accidents, injuries, or near-misses. By mandating systematic reporting, the clause ensures that safety risks are quickly addressed, regulatory obligations are met, and future incidents can be prevented through timely intervention and corrective action.
Safety Event Reporting. Additionally, each Party shall provide to the other Party prompt written notice of any material safety events pertaining to Therapies of which it becomes aware including any SUSARs or other material events which might have general applicability to the use of Candidates, TCRs or Therapies to treat patients. The Parties shall enter into a pharmacovigilance agreement on commercially reasonable terms to facilitate the reporting of such events.
Safety Event Reporting. Additionally, each Party shall provide to the other Party prompt written notice of any material safety events pertaining to any Product, including a Product developed by any third party, of which it becomes aware including any SUSARs, SAEs or other material events which [***]; provided, however, that nothing under this Section 6.3 shall require any Party to breach its obligations to any Regulatory Authority under Applicable Law and/or its confidentiality obligations to any third party under non-disclosure agreements or other similar agreements.
Safety Event Reporting. Additionally, each Party shall provide to the other Party prompt written notice of any material safety events pertaining to any Product of which it becomes aware, including any SUSARs, SAEs or other material events which might have general applicability to the development of any Product or the use of the Alpine Technology to develop any Product. The Parties will agree to the terms of a pharmacovigilance agreement if reasonably required to facilitate such safety event reporting.