STATE OF CALIFORNIA COMPREHENSIVE COMPLIANCE PROGRAM
Adopted in accordance with California law, this Comprehensive Compliance Program (“Compliance Program,”) reflects the commitment of lvantis, Inc. (“lvantis” or “Company”) to the highest ethical standards and responsible decision-making in its interactions with healthcare professionals. lvantis believes that adherence to all applicable laws, regulations, and industry standards are critical to the Company’s operations and success. The Compliance Program is designed to prevent and detect violations of applicable law, compliance standards, and other Company policies.
lvantis has adopted a Policy and Procedure for Interactions with Healthcare Professionals (the “Policy”). The principles in the Policy are based on legal requirements and applicable guidance, including industry guidance (e.g., the AdvaMed Code of Ethics on Interactions with Health Care Professionals and the Medical Device Manufacturers Association Revised Code of Conduct on Interactions with Healthcare Providers) and guidance from the U.S. Department of Health & Human Services Office of Inspector General. The term “Healthcare Professionals” includes all individuals and entities involved in the purchase or use of Company products, including those in a position to recommend or arrange for the purchase or use of Company products.
In response to California Health & Safety Code §§119400 et seq., lvantis has established an annual spending limit of $2,500 for gifts, promotional materials, items or activities directed toward “individual medical and healthcare professionals” in California.
COMPLIANCE OFFICER AND COMPLIANCE COMMITTEE
lvantis has appointed a Compliance Officer who is responsible for providing interpretive guidance in applying the Policy and related policies to specific situations and for generally overseeing implementation and enforcement of the Compliance Program. In addition, lvantis has designated a Compliance Committee consisting to provide compliance oversight to lvantis and to support the Compliance Officer. The Compliance Officer and/or his/her designee(s) conduct and/or monitor investigations into alleged violations of law and/or Company policies or procedures, including the Company’s Code of Conduct and the Policy. As a result of these investigations, the Compliance Officer, and others as appropriate, determines appropriate corrective, preventative and/or disciplinary actions to be taken and monitors to ensure that such actions are taken.
TRAINING & EDUCATION
lvantis recognizes that training and education are key parts of an effective compliance program. Employees who interact directly or indirectly with Healthcare Professionals receive training on the Policy. Additional ethics and compliance education and training programs are provided on an ongoing basis as required by an individual’s job responsibilities and by changes in the laws and Company policies and procedures. Training records are maintained in accordance with Company policy.
REPORTING VIOLATIONS OF THE COMPLIANCE PROGRAM
Employees customers, suppliers and others are encouraged to contact the Compliance Officer with questions or concerns. Concerns may also be reported anonymously by letter addressed to 38 Discovery, Suite 150, Irvine, California 92618 to the attention of the CEO, the Board of Directors, or the Compliance Officer. Information regarding reporting violations is included in the Company’s Code of Conduct. Employees may also ask questions of, or report concerns to, supervisors and other members of management. There will be no retaliation against anyone who has reported a suspected violation or concern in good faith. The Company encourages anyone who reports information to identify themselves when making such a report in order to facilitate investigation of the possible violations (subject to compliance with local laws), but reports may also be made anonymously.
CORRECTIVE OR PREVENTIVE ACTION
The Compliance Program is designed to prevent and detect conduct that may be inconsistent with the requirements of applicable law or regulations or the Policy. If improper conduct is detected, lvantis will address it promptly and responsibly with corrective action including, but not limited to, appropriate disciplinary measures. The Company will assess whether violations of the Compliance Program, including the Policy, are a result of gaps in policies, practices, training, internal controls or individual acts, and will take action to prevent future violations.
MONITORING AND PERIODIC REVIEW
The Compliance Officer and/or the Compliance Officer’s designee(s), with support from the Compliance Committee, will monitor the implementation and administration of the Compliance Program, including monitoring the activities of sales and marketing personnel. As part of that oversight, the Compliance Officer and/or his designee(s) and the Compliance Committee will review Company operations and industry developments, to identify new and emerging risk factors for the Company in its relationships with Healthcare Professionals. The Compliance Officer and/or his designee(s) will report on a regular basis to the Board of Directors and to the Compliance Committee as to the status of the Compliance Program, including its implementation and an assessment of its effectiveness and areas that may need improvement.
COPIES OF COMPLIANCE PROGRAM AND ANNUAL DECLARATION OF COMPLIANCE
Copies of this Compliance Program, the Code of Conduct, and lvantis’s Annual Declaration of Compliance can be obtained by calling lvantis’s toll-free number at 1-866-IVANTIS or sending us an email stating your request to ComplianceOfficer@ivantisinc.com.
DECLARATION OF COMPLIANCE
As of the date of this declaration, lvantis declares that, to its knowledge, it is in compliance with its Compliance Program and with California Health and Safety Code § 119402, in all material respects.