Compliance & Transparency
Compliance & Transparency
At ImmunityBio, we act with integrity in all that we do so that we can fulfill our mission: to continuously pursue new therapies that kill disease, not the immune system.
Our mission guides us in making the right decisions ethically and responsibly so that our business can meet our patients’ needs. Our colleagues are expected to take personal ownership of compliance as we strive to positively impact patients’ lives and support them in their fight against cancer.
Our Compliance Program is designed to help achieve our mission by promoting ethical behavior, accountability, and proactive risk management that is embedded throughout our business.
Our program incorporates 7 fundamental elements based on industry best practices and government statements and expectations on effective risk management. We continuously enhance our Compliance Program, taking into consideration current and emerging business strategies and practices, benchmarking, and the external environment. The program supports ImmunityBio’s commitment to enable an ethical, responsible, and transparent business model to advance our mission, drive innovation, and deliver positive impact to patients.
The Audit Committee of the ImmunityBio Board of Directors oversees the Compliance Program and the Company’s Chief Compliance Officer. The intent of the Board and Company officers is to set the tone for the ethical behavior expected of all Directors, officers, employees, and business partners.
The Chief Compliance Officer has primary responsibility for strategic program planning related to the Compliance Program including ensuring that training, policies and procedures, communications, auditing and monitoring, and corrective action processes are developed, in place, and modified as needed.
ImmunityBio’s Code of Conduct & Business Ethics and Compliance Manual (including all compliance policies, procedures, and/or processes) are integrated across the organization with department specific procedures or guidance as needed. Among other things, our policies and procedures address the PhRMA Code and gifts to medical or health professionals. ImmunityBio Directors, officers, and employees are expected to comply with all of the Company’s compliance policies, procedures, and processes. The total value of all gifts, promotional materials of monetary value, and incentives that may be provided to any individual medical or healthcare professional during any calendar year shall not exceed $2,500.00. For the avoidance of doubt, the amounts paid for bona fide services provided to ImmunityBio and similar payments permitted under the PhRMA Code are excluded from this calculation. This annual limit shall be monitored and subject to periodic review by the Compliance department.
Education is a key element of our Compliance Program. Upon hire, all employees receive training on the Code of Conduct. Specialized training occurs in specific departments and across the Company for issues where compliance risks might be greater or where a need for additional training has been identified. The specialized training may include, but is not limited to, modules related to: privacy, the marketing and sales of prescription drugs, and compliance generally. In addition, the trainers and sales managers periodically address compliance issues at regional and national sales meetings. Training is updated as needed for reasons that may include changes in the law, new risk areas, and changes to the PhRMA Code or other regionally specific codes or laws.
Our Program includes education and training of our Directors, officers, and employees on the Company’s Compliance Program and compliance related activities, risks, and laws.
ImmunityBio is committed to maintaining the awareness of the Program through communication to its employees. ImmunityBio distributes communications to employees through a variety of methods including but not limited to the following: all-hands meetings, broadcast emails, and letters. ImmunityBio also maintains a toll-free hotline for reporting of compliance concerns and a process for investigating and documenting concerns.
ImmunityBio – Web Intake Site URL’s, Mobile Intake Site, & Phone Number:
-Direct URL https://secure.ethicspoint.com/domain/media/en/gui/94078/index.html
-Mobile Intake Site: https://immunitybiomobile.ethicspoint.com/
-Toll-free Telephone Number: 833-765-8563
ImmunityBio encourages Directors, officers, and employees to promptly report suspected or actual violations of our Program and laws and regulations governing our business. Our toll-free hotline allows for anonymous reporting (except where prohibited by law) and is monitored by the Compliance Officer.
Auditing and Monitoring
As part of the Compliance Program, ImmunityBio conducts auditing and monitoring activities designed to assess compliance with the Program policies, procedures, and processes, identify potential training needs and identify policy, procedure, or process needs.
Investigations & Corrective Action
ImmunityBio takes reports of known or suspected violations of company policies and applicable law seriously; our goal is to respond promptly to all questions and reported concerns. We aim to identify and address potential inappropriate conduct as early as possible, prevent future recurrences, and inform continuous improvement. We investigate all referable compliance issues — significant potential, suspected, or actual violations of law or policy.
For referable compliance issues where there is a substantiated violation, we institute individual discipline where appropriate and analyze root cause. After investigation, we work with accountable stakeholders to implement corrective and preventive actions, and we also consider such actions throughout the investigation as appropriate. ImmunityBio has a process to escalate certain significant matters to the Executive Committee and/or the Audit Committee of the Board.
Transparency
ImmunityBio recognizes that ethical relationships with healthcare professionals and organizations are critical to its mission of helping patients by developing and marketing new medicines. Our interactions with healthcare professionals and organizations are professional exchanges intended to enhance the practice of medicine for the benefit of patients, and we follow the highest standards of integrity, ethical conduct, and full compliance with the laws, regulations and applicable codes of marketing practice, including the PhRMA Code on Interactions with Healthcare Professionals. Additionally, we also comply with applicable disclosure and declaration requirements related to interactions and transfers of value provided to reportable recipients, such as the U.S. Sunshine Act.
The Physician Payment Sunshine Act (Sunshine Act) was passed as part of healthcare reform in March 2010 and was in effect as of August 1, 2013. The Sunshine Act, also referred to as “Open Payments,” requires pharmaceutical manufacturers such as ImmunityBio, medical device companies, and group purchasing organizations (GPOs) to track and report certain ownership interests, payments and transfers of value, including meals, refreshments, educational items and fee-for-service compensation provided to U.S. physicians and teaching hospitals.
ImmunityBio complies with the disclosure requirements and encourages individuals to reference the Open Payments website, which is managed by the Centers for Medicaid and Medicare Services (CMS), for additional information.
If there are any questions or inquiries related to data submitted by ImmunityBio, please contact our Transparency team at Transparency team at compliance@immunitybio.com
DECLARATION OF COMPLIANCE FOR CALIFORNIA
Click the documents below for a description of ImmunityBio’s Comprehensive Compliance Program pursuant to the California Marketing Practices Act:
Read our Declaration of Compliance for CA.
Read more about the ImmunityBio Compliance Program for CA.