Compliance is a Priority at Sentynl Therapeutics

Comprehensive Compliance Program


Annual Declaration of Compliance

July 1, 2016

Based upon a good faith understanding of the applicable statutory requirements, Sentynl Therapeutics, Inc. (“Sentynl” or the “Company”) believes that its Compliance Program meets or exceeds the requirements of California Health & Safety Code §§119400-119402. Sentynl also believes that it complies with its Compliance Program in all material respects. Copies of this statement may be downloaded by clicking on the link at the bottom of this page, by calling (877) 767-2656 or by sending an email request to Compliance@Sentynl.com.

Sentynl has established an annual dollar limit of $2,500 on certain transfers of value to individuals licensed to prescribe drugs to human patients, medical students, or members of formulary committees in any fiscal year in accordance with California law.  This dollar limit represents a spending cap, not a goal or average, and typically the amount spent per physician is anticipated to be substantially less than this maximum amount.  Drug samples for patients and professional service fees that conform to the HHS-OIG Guidance and PhRMA Code are excluded from this limit.

I.  Introduction

Sentynl is committed to implementing and maintaining an effective Compliance Program in accordance with all applicable laws, policies, and industry standards. Sentynl’s Compliance Program is also consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers, published in 2003 by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”) and the Code on Interactions with Healthcare Professionals created by the Pharmaceutical Research and Manufacturers of America (“PhRMA Code”).

Sentynl’s Compliance Program and corporate culture are designed to promote proper legal and ethical conduct by all employees. In the event of noncompliance with applicable laws, industry standards, and/or company policy, Sentynl will investigate in a timely manner and, where appropriate, enforce disciplinary action and establish corrective measures to prevent future violations. The fundamental elements of Sentynl’s Compliance Program are described below. Sentynl’s Compliance Program is regularly reviewed and enhancements are continuously made.

II. Overview of Compliance Program

1.       Leadership and Structure

Chief Compliance Officer: The Chief Compliance Officer is responsible for overseeing the development and implementation of policies, procedures, and practices designed to ensure compliance with applicable laws.  Additionally, the Chief Compliance Officer is responsible for the Company’s day-to-day compliance activities, including overseeing internal and external compliance audits and investigations. The Chief Compliance Officer is a member of Sentynl’s senior management, reports directly to the Chief Executive Officer, and has direct access to Sentynl’s Board of Directors.

Compliance Committee: The Compliance Committee is chaired by the Chief Compliance Officer and is composed of senior individuals representing multiple business units and disciplines across the Company.  Members of the Committee are empowered to effectuate change within each department with respect to compliance related matters. The Compliance Committee supports the Chief Compliance Officer in fulfilling his responsibilities and provides input into Sentynl’s compliance policies.

2.       Written Standards

Sentynl has implemented written policies and procedures that provide employees with the necessary guidance to act ethically and in compliance with all applicable laws, regulations and industry guidelines when conducting business on behalf of the Company.

3.       Education and Training

Sentynl is committed to providing its employees with the education and training they need to carry out their responsibilities in an ethical manner and consistent with all applicable laws, regulations, and industry standards. All employees complete training on the Company’s written policies and procedures, which includes testing and follow-up education as necessary. Additionally, more specific training is provided to employees regarding the policies and procedures of their respective departments. The content for all training is reviewed annually at a minimum and updated in accordance with changes in applicable legal and ethical guidelines, or for other purposes.

4.       Internal Lines of Communication

Each Sentynl employee is required to report any circumstances that the employee believes in good faith may constitute a violation of the Company’s written policies and procedures, as well as other laws and policies. To foster this open line of dialogue, Sentynl has developed a corporate culture that emphasizes open-door communication with employees of all levels.

5.       Auditing and Monitoring

Sentynl performs regular auditing and monitoring of its business activities to assess compliance with its policies and procedures. In accordance with the HHS-OIG Guidance, the nature, extent and frequency of compliance monitoring and auditing varies according to a number of factors, including an assessment of the relative risks, new regulatory requirements, changes in business practices, and other considerations. The Chief Compliance Officer is responsible for internal and external audits and investigations.

6.       Response to Potential Violations

As the HHS-OIG Guidance recognizes, the implementation of a compliance program cannot guarantee that improper conduct will be entirely eliminated. Sentynl’s policies provide that any individual who becomes aware of or suspects a compliance violation has occurred must promptly contact the individual’s supervisor, Sentynl’s Human Resources Department, the Chief Compliance Officer or the anonymous compliance hotline.  Sentynl prohibits retaliation against any individual who reports a known or suspected violation in good faith.

The Chief Compliance Officer will determine, depending on the nature of the incident, the appropriate individual or department to handle the investigation. All Sentynl personnel must cooperate with any investigation of a known or suspected violation and answer all inquiries truthfully. Any Sentynl employee who withholds information or attempts to mislead or misdirect an investigation is subject to disciplinary action, up to and including termination.

The Chief Compliance Officer will ensure that prompt disciplinary action is taken, up to and including termination, against any individuals who commit violations of applicable laws, regulations, industry standards or Company policies.  Sentynl will also assess whether and to what extent violations are attributable to gaps in the Company’s policies and procedures, and if so, take appropriate corrective action to prevent future violations.