Dextera Surgical Incorporated
State of California
Comprehensive Compliance Program
November 4, 2016
Adopted in accordance with California law, this Comprehensive Compliance Program (“CCP”) reflects the commitment of Dextera Surgical Incorporated (“Dextera Surgical” or “Company”) to act in accordance with the highest standards of corporate conduct and ethics. Dextera Surgical believes that adherence to applicable laws, regulations, and industry standards is critical to the Company’s operations and success.
As of the date above, Dextera Surgical declares that, to the best of its knowledge and based on a good faith understanding of the requirements of the statute, it is in compliance with this CCP and with California Health & Safety Code §119402 in all material respects.
The Company has developed this CCP in accordance with the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”), the California Health and Safety Code §§119400 et. seq., the Anti-Kickback Statute, the Physician Payments Sunshine Act, and other applicable state, federal, and international laws. Consistent with the OIG Guidance, Dextera Surgical has adopted a CCP that is designed to fit the size and structure of the company.
This CCP is designed to meet requirements relevant to a medical device manufacturer. The medical device industry has established the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the “AdvaMed Code”), which is substantially equivalent to the PhRMA Code referenced in California Health & Safety Code §119402, but which reflects the unique interactions between medical device companies and healthcare professionals. Accordingly, our CCP includes policies for compliance with the current AdvaMed Code of Ethics on Interactions with Health Care Professionals.
The Compliance Program is designed to prevent and detect violations of applicable law, compliance standards, and Company policies. It is our expectation that every Dextera Surgical employee meets ethical standards, and that interactions between Dextera Surgical employees and healthcare professionals and others are conducted with appropriate transparency and in compliance with applicable laws, regulations and government guidance.
As part of this CCP, and consistent with California Health & Safety Code §119402, Dextera Surgical has established an annual per-practitioner spending limit of $1500 for gifts, promotional materials, items, and activities directed toward “individual medical and healthcare professionals” in the State of California.
The elements of Dextera Surgical’s CCP are described below.
Dextera Surgical has appointed a Compliance Officer who reports to the Chief Financial Officer. The Compliance Officer is responsible for establishing and overseeing the CCP, and for providing interpretive guidance with regard to applicable laws and ethical standards. The Chief Compliance Officer makes periodic reports to the Board of Directors, and is empowered to communicate to the Board any compliance or ethical matters that require Board attention.
Written Policies, Procedures and Training
This CCP includes the Code of Business Conduct and Ethics and the Employee Handbook. The Code of Business Conduct and Ethics is available on the Company’s website at ir.dexterasurgical.com.
Dextera Surgical periodically trains its employees on the provisions of this CCP, particularly employees who interact with healthcare professionals. The Company maintains records of this training.
Communication Regarding Compliance Matters
Dextera Surgical has adopted confidentiality and non-retaliation policies, as set forth in the Code of Business Conduct and Ethics and the Employee Handbook, to encourage employees to report any potential violations of this CCP. Dextera Surgical provides an anonymous, confidential reporting system that includes a toll-free, 24-7 telephone service to allow employees and others to ask questions and/or report possible violations of this CCP, without fear of retaliation, anonymously if desired.
Employees are encouraged to ask questions of and/or report concerns to their immediate supervisor, to any member of management, or to the Chief Compliance Officer. There will be no retaliation against anyone who has reported a concern or a suspected violation in good faith.
Corrective or Preventive Action
The Company will assess whether any violation of the CCP is a result of gaps in policies, practices, training, internal controls, or individual acts, and will take action to prevent future violations. If improper conduct is detected, Dextera Surgical will address it with corrective action that includes, as appropriate, disciplinary action against individuals.
Monitoring and Periodic Review
Dextera Surgical makes ongoing efforts to monitor, audit and assess compliance with this CCP. The CCP is regularly reviewed to ensure that it still meets applicable legal and ethical requirements.
A hardcopy of this CCP can be obtained by printing this webpage from your browser, or by calling our toll-free number at (888) 544-7194.