Common use of Vigilance System Clause in Contracts

Vigilance System. Medica shall handle any and all international product complaints and vigilance reporting that results from the use of Nephros product. A monthly trending report shall be issued to Nephros Quality Assurance detailing the aforementioned complaints and vigilance incidents and corrective action activities. The following statements outline the responsibilities for the handling and reporting of complaints and vigilance reportable incidents: a) All vigilance reports shall be communicated to Nephros Quality Assurance within 24 to 48 hours of evaluation and confirmation. b) All individual complaints shall be communicated to Nephros for evaluation and confirmation. c) Complaints shall be evaluated for confirmation both by Medica upon receipt and by Nephros following communication from Medica. d) Complaint investigations shall be a shared process between Medica (QA, Manufacturing, and Engineering) and Nephros (QA and R&D). e) All investigation reports shall be issued jointly and in a timely manner to satisfy the requirements for vigilance reporting (when necessary). f) When a complaint is determined to be a vigilance reportable event then Medica shall be responsible for administering and reporting Nephros product related vigilance incidents to the necessary competent authorities within 10 days or as outlined in the Nephros Quality System. g) Any vigilance reportable complaint shall be forwarded to the Nephros Authorized Representative for reporting to the appropriate Competent Authority h) Medica shall copy Nephros Quality Assurance within 24-48 hours on all and any vigilance reporting, including health outcome, relationship between the incidents, and timeliness of reporting the vigilance incident to the Competent Authorities.

Vigilance System. Medica shall handle any and all international ---------------- product complaints and vigilance reporting that results from the use of Nephros product. A monthly trending report shall be issued to Nephros Quality Assurance detailing the aforementioned complaints and vigilance incidents and corrective action activities. The following statements outline the responsibilities for the handling and reporting of complaints and vigilance reportable incidents: a) All vigilance reports shall be communicated to Nephros Quality Assurance within 24 to 48 hours of evaluation and confirmation. b) All individual complaints shall be communicated to Nephros for evaluation and confirmation. c) Complaints shall be evaluated for confirmation both by Medica upon receipt and by Nephros following communication from Medica. d) Complaint investigations shall be a shared process between Medica (QA, Manufacturing, and Engineering) and Nephros (QA and R&D). e) All investigation reports shall be issued jointly and in a timely manner to satisfy the requirements for vigilance reporting (when necessary). f) Medica will serve as the Authorized Representative for Complaint and Vigilance handling and reporting for Nephros a. The Medica name shall appear in small print on the Nephros product label as contact information regarding complaint and vigilance reporting. g) When a complaint is determined to be a vigilance reportable event then Medica shall be responsible for administering and reporting Nephros product related vigilance incidents to the necessary competent authorities within 10 days or as outlined in the Nephros Medica Quality System. gh) Any vigilance reportable complaint shall be forwarded to the Nephros Authorized Representative Medica for reporting to the appropriate Competent Authority. hi) Medica shall copy Nephros Quality Assurance within 24-48 hours on all and any vigilance reporting, including health outcome, relationship between the incidents, and timeliness of reporting the vigilance incident to the Competent Authorities.