CORPORATE RESPONSIBILITY STATEMENT
At Assertio Holdings, Inc. (“Assertio”), we approach corporate responsibility
in the same manner as we approach our business and our compliance program –
with an approach that is based on our four core principles (“Core Principles”) and the three
pillars (“Pillars”) that support our Core Principles.
Our Core Principles, each of which is further defined below, serve as the touchstones that
we expect to guide our employees’ actions on behalf of the Company, including with regard to
compliance with applicable laws and regulations. The Core Principles form the foundation of our
business and guide the daily interactions of all employees, including sales representatives.
Further, our sense of corporate responsibility is pursued with integrity in accordance with
applicable industry standards, laws and regulations.
The core principles that form the foundation of our business and guide the daily
interactions of all employees, including sales representatives, are as follows:
Ethically Promote Our Products
We are committed to promoting our products in an ethical manner. To ensure
compliance with this Core Principle, all sales representatives who are involved in the promotion
of a particular Company product are expected to know and understand the information in the
product’s label, and must successfully complete Company product training and compliance
training consistent with the Company’s comprehensive compliance program. In promotional
interactions with healthcare professionals (“HCPs”), consumers, or any other external party,
sales representatives are expected to communicate truthful, on-label information about Company
products, and all discussions are required to be consistent with the Company’s comprehensive
To facilitate ethical promotion of Company products, we provide thorough training to our
sales representatives to educate them on the legal and ethical principles that apply to product
promotion. We use a variety of media and communication strategies to enhance the
effectiveness of our training program. Our sales representatives are expected to comply with the
training they receive.
Preserve the Relationship between Healthcare Professionals and Patients
We believe that patient care should be based on patient needs and a HCP’s medical
knowledge and experience, and that patient care should not be improperly influenced by
individuals or entities outside of the HCP/patient relationship. Therefore, we believe our
interactions with HCPs should be focused on informing HCPs about our products, providing
scientific and educational information, and supporting medical research and education. To
ensure the integrity of medical decisions, we do not offer or provide improper inducements or
rewards to HCPs or consumers.
Ensure Patient Safety and Access to Company Products
We are committed to ensuring the safe use of our products. Safe use of medical products
may require instruction, education, training and technical support. In such instances, we provide
HCPs with educational programs and training related to our products. We also provide support
to independent external organizations that provide important educational opportunities to HCPs.
Patient access to physician prescribed medical products can be challenging. The cost of
medical products can also be financially burdensome for many patients. We support programs to
help reduce such barriers to access so patients may get the medicines their physicians determine
is most appropriate based on their medical condition.
Protect Patient Privacy
We recognize the importance of protecting patient privacy and have established policies
and requirements to avoid affirmative contact with confidential patient information (unless
patient consent is received) and to ensure appropriate handling of any confidential patient
information that our sales representatives inadvertently receive. Any business activities
involving patients or consumers are expected to be conducted in accordance with applicable
industry standards, laws, and regulations, and the Company’s comprehensive compliance
Our commitment to corporate responsibility, both in our business and in our compliance
program, is supported by the Pillars described below. Our training programs and
organizational structures have been developed to enable everyone to understand the Pillars and
how to implement them to support our Core Principles.
We are inspired by patients. This inspiration motivates us to develop and make available
high-quality medicines that help people live longer, healthier lives. We continually challenge
ourselves to meet and exceed the highest standards of performance, integrity and compliance.
By endeavoring to always putting patients first, we believe we can ensure that we can meet the
high standards we aspire to achieve.
Ethical and Responsible Interactions with Healthcare Professionals
Ethical and responsible relationships with HCPs are critical to our mission of helping
patients by developing and marketing needed medicines. In order for HCPs to make the right
choices for their patients and achieve positive health outcomes, we believe it is important that
HCPs understand the attributes of available treatment options. An important part of achieving
our mission is to ensure that in our interactions with HCPs, we provide information about the
risks and benefits of our products and their role in patient healthcare. We have developed
compliance policies and employee training programs that provide guidance on appropriate
interactions with HCPs and emphasize adherence to applicable laws and regulations for all
employees who market our products.
Tone at the Top
Our leaders and managers are responsible for establishing and maintaining our culture
and integrating that culture into everything we do. The tone at the top reinforces our guiding
values and ethical culture. Properly nurtured, we believe that this corporate value is the
foundation upon which the culture of our company is built.
We are committed to conducting business with the highest degrees of integrity,
professionalism and social responsibility. We are also committed to complying with all of the
laws, regulations, and industry codes of conduct that apply to our business.
Annual Declaration of Compliance pursuant to California Health and Safety Code §§ 119400 – 119402 Assertio Holdings, Inc. (Assertio)
Assertio has established and maintains a comprehensive Compliance Program that is consistent with the requirements of California Health and Safety Code sections 119400 and 119402. As required by California Health and Safety Code section 119402, with specific reference to the provision of gifts, promotional material, or items or activities that a pharmaceutical company may provide to an individual medical or healthcare professional, Assertio has established an aggregate, annual dollar limit of $2,500 on promotional items and/or meals directed to an individual medical or healthcare professional who resides or practices in California. The dollar limit is a maximum only. Assertio declares that, to the best of our knowledge, and based on our good faith understanding of the statutory requirements of the California Health & Safety Code sections 119400 and 119402, we are in compliance with our comprehensive Compliance Program. Copies of this declaration and the Comprehensive Compliance Program for Sales and Marketing Activities may be obtained by calling Assertio’s Confidential Alertline at 1-800-779- 3381 or from Assertio’s website at www.assertiotx.com.
Date: July 1, 2020
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.
Assertio’s Action Plan
Over the last few weeks, we have merged the strengths of our two organizations. I have been humbled by messages of hope and excitement shared by many of you for the future of Assertio. For our company, these truly are exciting times, however the start of our organization comes at a time of incredible turmoil in our country. While we’ve been navigating the impact of Covid-19 and the subsequent unprecedented economic headwinds, the more tragic issue of racism against the Black community and individuals with a much longer history needs to be addressed.
The senseless killing of George Floyd and too many others before him are grotesque examples of racism and the injustices that still exist in our country today. Like all of you, I feel a flood of emotions: anger, sadness, frustration, and an unending struggle to process how this continues to happen in our country. As a father, brother and son, I think about the devastation experienced by his family. As a volunteer advocate for kids in the foster system over the past three years, I have seen first-hand how prevalent and devastating racism and inequalities are. I pray that swift justice will be served which may provide a small measure of closure for the Floyd family, but a significant stain on our nation will remain.
If we let another civil rights catastrophe unfold with leaders sharing hollow words without action, it will be a larger insult to a tragic event. For those who do not yet know me well, you will find out that I fundamentally believe that any words I share must be accompanied by action, no matter the issue or circumstances. Over the last several days, I have worked with our executive team, HR colleagues and others to determine what we can do to meaningfully augment Assertio’s commitment to the principles of diversity and inclusion. We have the opportunity – the responsibility – to define the culture of our newly formed company; this is essential to our success as a business and more importantly as colleagues forming our community.
While the foundational elements of our policy are sound, we are forming an inclusion and diversity team comprised of a cross-section of our employees to consider ways to improve our programs and actions. Sarah Longoria, our head of HR, will benchmark what best-in-class organizations and companies have adopted. Our team will meet with leadership regularly and will help develop, review and adopt policies and initiatives consistent with building the culture and community we can be proud of at Assertio. Please feel free to share any thoughts, suggestions, concerns or examples, I look forward to hearing and learning from everyone.
Another step we are taking immediately is to give all Assertio employees a day of service to give back to our community through volunteering, activism and community engagement. This will be a permanent additional day that employees can use when needed. I’m excited to hear how each of you use this day.
As a company, we will continue to support important local community efforts in Lake County through our sponsorship of United Way and Court Appointed Special Advocates (CASA), two organizations that are primarily focused on early childhood education, economic empowerment and advocating for abused and neglected children or those marginalized within the juvenile court system. We have made an additional donation to CASA to further help their cause at this time when many community organizations are struggling with fund raising due to Covid-19.
We should never give up hope and recognize that we are all leaders who can make a difference. As Martin Luther King Jr. said, “we will remember not the words of our enemies, but the silence of our friends.” I look forward to working together in creating a stronger company—one that consistently and equitably values all our employees and is a force for good in our communities.
Todd Smith, President & Chief Executive Officer