Proove Biosciences (“Proove” or the “Company”) has adopted a Comprehensive Compliance Program (“Compliance Program”), summarized below and consistent with guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”). Proove’s Compliance Program is intended to promote the prevention and resolution of actual or apparent conflicts of interest, appropriate disclosure in Company reports and public communications, compliance with applicable laws and regulations, accountability and prompt reporting of violations of Company policy relating to the sale and marketing of Proove’s products. It is Proove’s expectation that all employees, officers, directors, agents, representatives, consultants and distributors shall comply with Company policies and procedures as well as all of the laws, rules and regulations of the U.S. and other countries, and the states, counties, cities and other jurisdictions, applicable to the Company’s sale or marketing of its products. The strategic objectives of our Compliance Program are:
- To promote an organizational culture that encourages a passion to make a difference in the world, engage in ethical conduct, a commitment to integrity and quality, and compliance with applicable laws and regulations.
- To exercise due diligence to prevent, detect and correct potential violations of the Compliance Program, applicable federal and state law, and Company policy.
- To provide a comprehensive approach to identifying, managing and mitigating organizational risk.
COMPREHENSIVE COMPLIANCE PROGRAM SUMMARY
The OIG advises that an effective compliance program is comprised of seven elements. Proove has used these seven elements as a basis for its Compliance Program. Fundamental elements of our compliance program are summarized below.
- Written Policies and Procedures: Proove has adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals as the Company’s primary statement of policies for assuring compliance with applicable laws, regulations and standards governing the marketing and promotion of Proove products. To the best of its ability and consistent with the OIG’s guidance regarding tailoring compliance programs to the nature of Proove’s business.
- Compliance Leadership: The Company has appointed a Compliance Committee headed by the Vice President and Chief Legal Officer, Laura Hunter, to help the Company meet legal and regulatory requirements applicable to the Company.
- Education and Training: The Company trains appropriate employees on their legal and ethical obligations and Proove’s policies and procedures concerning marketing and promotional activities relevant to Proove products. Proove regularly reviews and updates its training programs as needed. The Compliance Committee will work with other employees to implement or update appropriate training programs, including specialized training as needed, as well as documenting and maintaining records of such training.
- Communication: Proove encourages employees to talk to supervisors, managers, the Compliance Officer, any member of the Compliance Committee or other appropriate personnel about suspected illegal or unethical conduct or violations of Proove’s policies. Proove has adopted open-door, confidentiality (to the extent possible) and non-retaliation policies in the event an employee is concerned about a potential violation. Employees may also use the Company’s anonymous Hotline at 844-420-0044 (English
REPORTING OF VIOLATIONS; NO RETALIATION
Any employee who suspects a violation of the Company policy, financial fraud, accounting irregularities, or auditing issues should promptly contact the the Compliance Committee, the Legal Department or Human Resources. Any employee wishing to make an anonymous report regarding suspected illegal behavior or financial fraud of any type may do so by calling the Company’s anonymous hotline at 844-420-0044 (English speaking USA and Canada) or 800-216-1288 (Spanish speaking North America). The anonymous hotline is intended only for reporting potential financial fraud, concerns regarding accounting controls or irregularities, auditing issues or illegal or unethical behavior in violation of Proove’s policies. For other workplace issues, employees should contact their manager or Human Resources. The Company will investigate and treat confidentially (to the extent possible) all reported potential violations. All employees are expected to cooperate in any internal or external investigations of possible violations of Company policy. The Company will not permit retaliation of any kind by, or on behalf of, the Company or its employees against good faith reports or complaints of potential violations involving financial irregularities, violations of Company policy or other illegal or unethical behavior.
Adopted: March 17, 2017
Last revised: March 17, 2017
Code of Business Conduct & Ethics Program
INTRODUCTION
Purpose
Proove Biosciences, Inc. (“
Proove”) is committed to conducting all business affairs in an honest, fair, ethical and legal manner. As a representative of Proove, you are expected to conduct yourself in a similar manner. The purpose of this Code of Business Conduct and Ethics (the “
Code”) is to set forth the guidelines for conducting Proove’s business consistent with the highest standards of business ethics and the law. All references to Proove, “we,” “our” and “us” in this document include any subsidiaries of Proove Biosciences, Inc.
Applicability
This Code applies to all members of Proove’s Board of Directors, and all officers and employees of Proove, wherever they are located and whether they work for Proove on a full- or part-time basis. We also expect that anyone conducting work on Proove’s behalf in any consulting or advisory capacity will adhere to the provisions of this Code in the course of such work. Therefore, all vendors, service providers, temporary workers, independent contractors and consultants (the “
trade”) who provide services to Proove and who we designate will be provided with a copy of this Code and will be expected to abide by it. All persons covered by this Code are referred to as “
Proove employees” or “
employees” in the Code whether or not you fall into the trade category above. Such designation in no way implies or creates a contract for employment between you and us.
Seeking Help and Information
The Code is just one element of our overall effort to ensure lawful and ethical conduct in all aspects of Proove’s business. The Code is not intended to be a comprehensive document that addresses every situation that you may face while working at, for or with Proove. In fact, there are many policies and procedures not covered by the Code, such as those covered in our detailed employee handbook. These and similar policies, while not a part of the Code, provide additional guidance on acceptable standards of conduct to be observed in the representation of Proove. The Code does not take the place of or modify other more detailed written policies. Rather, this Code establishes key standards and general guidelines that Proove expects all employees to follow.
If you are faced with a difficult business decision that is not addressed by the Code, you should ask yourself the following questions:
- Is it legal?
- Is it honest and fair?
- Is it in the best interests of Proove?
- Would I feel comfortable if an account of these actions were published with my name on the front page of the newspaper?
If your answer to any of these questions is “no” then don’t do it. If you aren’t sure about the answer to any of these questions or still feel uncomfortable about a situation, please seek help. We urge you to contact your supervisor for help. If your supervisor cannot answer your question, or if you are not comfortable discussing the situation with your supervisor or with your supervisor’s answer, feel free to contact the Chief Legal Officer.
Chief Legal Officer
The Company’s Chief Legal Officer is responsible for monitoring performance under the Code, assuring compliance with all other applicable local, state and federal laws and regulations, and resolving concerns or questions relating to ethics. The Chief Legal Officer can be reached at 855-776-6832,
lhunter@proove.com or Proove Biosciences, Inc., 15326 Alton Parkway, Irvine, CA 92618. In the absence of the Chief Legal Officer, you can contact the President and Chief Executive Officer, who has established an “open door policy” for all employees, at 855-776-6832 or
bmeshkin@proove.com.