Posted on 08/31/17
Pernix Therapeutics Holdings, Inc. Comprehensive Compliance Program
This Comprehensive Compliance Program for Sales and Marketing Activities (the “Compliance Program”) of Pernix Therapeutics Holdings, Inc. (“Pernix”) is a program to promote compliance with applicable laws, rules, and regulations and to promote ethical and responsible decision making in the sale and marketing of Pernix’s pharmaceutical products.
Pernix will review and update this Compliance Program from time to time as it reasonably deems appropriate.
B. Compliance Officer and Compliance Committee
Pernix has designated a Compliance Officer to ensure the integrity of and to implement Pernix’s Compliance Program. In addition, Pernix has designated a Compliance Committee consisting of senior management and other personnel to provide compliance oversight to Pernix and to support the Compliance Officer.
C. Written Standards of Conduct, Policies, and Procedures
Pernix has developed written policies and procedures addressing compliance issues in connection with its interactions with medical and other healthcare professionals and related activities. These policies and procedures are designed to ensure compliance with the recommendations set forth in the “Compliance Program Guidance for Pharmaceutical Manufacturers” of the United States Department of Health and Human Services’ Office of the Inspector General, and in the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (commonly known as the “PhRMA Code”). The Compliance Committee is responsible for approving such written policies and procedures and will periodically review and revise certain policies and procedures as it deems appropriate.
Pernix’s compliance policies and procedures are distributed to all employees. All Pernix personnel are required to participate in training relevant to their positions as a condition of their employment and certify in writing as to their participation in such training. All employees are required to undergo additional periodic training as deemed necessary by the Compliance Committee.
E. Monitoring of Sales and Marketing Programs
From time to time, Pernix will select certain sales and marketing programs to review in order to confirm that the selected programs are being carried out in accordance with the relevant Pernix policies and procedures, as well as all applicable laws, regulations and rules. Each such review will be conducted by or under the supervision of the Compliance Officer, and will be documented and reported to the Compliance Committee.
F. Procedures for Reporting Violations
Pernix employees are encouraged to report any known or suspected compliance violations to their supervisor, to the Compliance Officer or to the Legal Department. Pernix has also established an Ethics Helpline that is available 24 hours a day, seven days a week at (800) 826-6762 or https://pernixtx.alertline.com. Employees may submit anonymous reports through the Ethics Helpline. All reports will be documented and reported to the Compliance Committee.
G. Investigations, Corrective Actions and Disciplinary Policies
In the event that Pernix becomes aware of any known or suspected compliance violation, through either the routine monitoring of its sales and marketing programs or a reported violation, designees of the Compliance Committee and/or the Audit Committee of Pernix’s Board of Directors will investigate the circumstances surrounding the known or suspected violation and will take appropriate corrective action, which may involve disciplinary action, up to and including termination.
H. Annual Dollar Limit on Gifts or Incentives Provided to Medical or Health Professionals in California
As required by, and in accordance with the definitions set forth in, California Health and Safety Code §119402(d)(1), Pernix has established an annual dollar limit on gifts, promotional materials, or items or activities that Pernix may give or otherwise provide to an individual medical or health care professional in the state of California, subject to the exclusions set forth in California Health and Safety Code §119402(d)(2)-(3).
I. Copies of Compliance Program and Annual Declaration
As part of Pernix’s commitment to uphold the highest standards of integrity in the conduct of its business, and in accordance with California Health and Safety Code sections 119400 and 119402, based on Pernix’s good faith knowledge, Pernix believes that it is in substantial compliance with its Compliance Program and the requirements set forth in California Health and Safety Code sections 119400 and 119402. This Declaration is effective as of September 1, 2017 for the January 1, 2016 through December 31, 2016 declaration period.
Copies of Pernix’s Compliance Program and Annual Declaration of Compliance can be downloaded from the Pernix website at www.pernixtx.com and can also be requested through Pernix’s Compliance Hotline at (800) 826-6762 or https://pernixtx.alertline.com.