Introduction

Ceribell, Inc. (“Ceribell”) is committed to establishing and maintaining a comprehensive and effective compliance program in accordance with California Health & Safety Code §§ 119400 – 119402, based on its good faith understanding of the statutory provisions as they may apply to a medical device manufacturer, the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, and other relevant regulatory guidance.

Compliance Program Overview

Ceribell’s Compliance Program, applied in conjunction with its Healthcare Professional Engagement Policy (“HCP Engagement Policy”), is tailored to Ceribell’s size, organizational structure, available resources, and the nature of its business as a medical device manufacturer. The AdvaMed Code is a voluntary ethical code substantially similar to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the “PhRMA Code”). The AdvaMed Code was developed with a primary focus on the unique interactions between medical device manufacturers and healthcare professionals, however, and is thus more uniquely suited to Ceribell’s compliance needs. The Compliance Program includes the following key components:

• General Counsel and Compliance Manager: Ceribell’s Compliance Program has been developed by Ceribell’s General Counsel and Compliance Manager and is jointly managed by them. They oversee the day-to-day operations and implementation of compliance policies and procedures.
• Reporting to the Board of Directors: The General Counsel provides regular reports on the status of the Compliance Program to the Audit Committee of the Board of Directors.

Written Standards

• Ceribell has established written policies and procedures, including the Code of Conduct and Business Ethics, to ensure compliance with relevant laws, regulations, and industry codes. Adherence to these standards is a condition of employment.

 Promotional Spending Limitation

• In accordance with California law, Ceribell has established an annual limit on promotional spending of $2,500 per California medical and health professional, which includes people licensed by California to prescribe prescription products, medical students, and members of drug formulary committees. This limit covers promotional materials, or items or activities that Ceribell may provide to a medical or healthcare professional in California (other than training or educational materials). This limit represents a spending cap and not an average or target, and in most instances the amount spent per physician will be substantially less than this annual limit.
• The annual limit excludes non-promotional spending such as: samples or demonstration units; financial support for continuing medical education forums or health education scholarships if provided in accordance with Ceribell policy; fair market value compensation for bona fide professional services, and any meals or other expenses related to the provision of such services; training programs necessary for the safe and effective use of Ceribell products; and items of nominal value with a retail value of less than $10.

Training and Education

• All employees receive comprehensive compliance training applicable to their job function and responsibilities, including training on the Compliance Program and Ceribell policies. Regular updates and specialized training are provided as needed.

Compliance Communications Internal Lines of Communication

• Ceribell encourages open dialogue between management and employees and maintains a “speak up” culture. Employees are encouraged to seek guidance and are required to report potential violations through multiple channels, including a  hotline, which allows anonymous notification and discussion of suspected or actual noncompliance without retaliation.

Auditing and Monitoring

• Ceribell conducts regular auditing and monitoring assessments to evaluate the effectiveness of the Compliance Program. Results are reported to the Legal Department and senior management to guide continuous improvement efforts.

Investigating and Responding to Potential Violations

• Ceribell promptly investigates reported or detected violations of law or company policy and takes appropriate disciplinary action and corrective measures to address potential gaps and prevent future violations.

Corrective Action

• Clear disciplinary policies are in place to address violations of law or company policy. Ceribell assesses whether disciplinary action is appropriate and takes action to prevent future violations, up to and including termination.

Conclusion

Ceribell declares, in good faith and to the best of its knowledge, that as of January 2024, it is in substantial compliance with its Comprehensive Compliance Program, which incorporates the principles articulated in the California Health and Safety Codes §§ 119400 – 119402, the AdvaMed Code of Ethics, and other relevant regulatory guidance. The Compliance Program is a fluid and ever-changing program designed to meet the evolving regulatory and legislative climate. It will be assessed on an annual basis to ensure its continued effectiveness and alignment with industry best practices.

Contact Information

For a copy of Ceribell’s Comprehensive Compliance Program Policy, please contact us at:

Compliance Hotline: 855-387-4431

Email: compliance@ceribell.com