Assertio Holdings, Inc. Comprehensive Compliance Program for Sales and Marketing Activities in Accordance with California Law
This Comprehensive Compliance Program for Sales and Marketing Activities (the “Compliance Program”) of Assertio Holdings, Inc. (“Assertio”) has been adopted by the Compliance Committee of Assertio, effective as of the date set forth below. The purpose of this Compliance Program is to promote compliance with applicable laws, rules, and regulations and to promote ethical and responsible decision making in the sale and marketing of its products. Assertio will review and update this Compliance Program from time to time as it reasonably deems appropriate.
B. Compliance Officer and Compliance Committee
Assertio has designated a Compliance Officer to ensure the integrity of and to implement Assertio’s Compliance Program. In addition, Assertio has designated a Compliance Committee consisting of senior management and other personnel to provide compliance oversight to Assertio and to support the Compliance Officer.
C. Written Standards of Conduct, Policies, and Procedures
Assertio 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 by the United States Department of Health and Human Services’ Office of the Inspector General, and in the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals. The Compliance Officer and/or 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.
D. 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 §§ 119400-119402, Assertio has established an annual dollar limit of $2,500 on meals associated with educational presentations, educational items, promotional materials and other items of value that Assertio may provide to an individual medical or health care professional in California.
Assertio’s compliance policies and procedures are distributed to all employees. Assertio personnel are required to participate in training relevant to their positions and certify in writing as to their participation in such training. All employees are required to undergo additional periodic training as deemed necessary to meet the objectives of the Compliance Program.
F. Monitoring of Sales and Marketing Programs
From time to time, Assertio 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 Assertio policies and procedures, as well as all applicable laws, regulations and rules.
G. Procedures for Reporting Violations
Assertio employees are encouraged to report any known or suspected compliance violations to their supervisor, to the Compliance Officer or to the Legal Department. Assertio has also established a Confidential Alertline that is available 24 hours a day, seven days a week at 1-800- 779-3381. Employees may submit anonymous reports through the Alertline. Confidential reports may also be made online at: https://assertiocompliancereport.alertline.com/gcs/welcome. All reports will be documented and reported to the Compliance Officer.
H. Investigations, Corrective Actions and Disciplinary Policies
In the event that Assertio 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 Officer 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.
I. Copies of Compliance Program and Annual Declaration
Copies of this Compliance Program and Assertio’s Annual Declaration of Compliance for California can be requested by calling the Confidential Alertline at 1-800-779-3381 or from Assertio’s website at www.Assertiotx.com.
Effective Date: As adopted on July 1, 2012. Updated May 20, 2020.