Compliance & Ethics

Vertos Medical Inc. (“Vertos Medical”) is committed to complying with all applicable laws governing the sale and marketing of, and price reporting for, our products, and to maintaining the privacy of patient health information. Accordingly, Vertos Medical has established a Comprehensive Compliance Program which enables Vertos Medical to ethically and legally promote its products and to avoid activities that may be viewed as improper inducements to increase the purchase or use of its products.

Statement regarding compliance with California Health & Safety Code § 119402

Pursuant to California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”), which requires pharmaceutical companies (and medical device companies) to adopt a compliance program in accordance with the Office of Inspector General (“OIG”) for the United States Department of Health and Human Services April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Program Guidance”) and policies for compliance with the Advanced Medical Technology Association “Code of Ethics on Interactions with U.S. Health Care Professionals” (“AdvaMed Code”) and Medical Device Manufacturers Association “Revised Code of Conduct on Interactions with Healthcare Providers” (“MDMA Code”) within six months of any update or revision of the AdvaMed Code or MDMA Code. The AdvaMed Code was revised and restated effective January 1, 2020. The MDMA Code was revised and adopted by the Medical Device Manufacturers Association on October 23, 2019.

Vertos Medical has established a Healthcare Compliance Program in accordance with the OIG Compliance Program Guidance and has policies in place to foster compliance with the AdvaMed Code and MDMA Code. Consistent with the requirements of the California Compliance Law and as part of the Healthcare Compliance Program, Vertos Medical has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that Vertos Medical may give or otherwise provide to an individual medical or health professional in California on an annual basis from January 1 to December 31. The $2,000 limit does not include the value of items expressly excluded by California law, including product samples given to physicians and healthcare professionals intended for free distribution to patients.

The items and activities covered by the law and Vertos Medical policy are primarily directed to the dissemination or communication of medical and scientific information as a resource for health professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Vertos Medical website. This limit represents a spending maximum, and the amount spent per medical or health professional may be significantly less than the maximum amount. Vertos Medical has established an internal monitoring system designed to help ensure compliance with the annual spending limit in California as well as other spending limits across the United States.

Annual Declaration (June 2020)

Vertos Medical is committed to conducting business activities in compliance with applicable laws, rules and regulations, and following the highest ethical standards in its interactions with all medical and health professionals and organizations. It is the policy of Vertos Medical that all interactions with medical and health professionals and organizations that are made on behalf of Vertos Medical are consistent with ethical business practices and socially responsible industry conduct. Vertos Medical’s Healthcare Compliance Program and related policies and procedures are an expression of this core value, and are intended to provide guidelines for complying with the law for all Vertos Medical personnel and agents.

To the best of its knowledge and based on a good faith understanding of the statutory requirements, Vertos Medical has established a Healthcare Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. Vertos Medical has tailored its Healthcare Compliance Program to meet the specific needs of Vertos Medical and continuously assesses the effectiveness of the Healthcare Compliance Program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and other similar spending limits across the United States. Therefore, subject to the limitations described above, Vertos Medical declares that, based upon current tracking and monitoring systems, Vertos Medical is materially in compliance with its Healthcare Compliance Program and applicable law, including the established annual spending limits in California for the period of January 1, 2019, through December 31, 2019.

For a written copy of Vertos Medical’s Healthcare Compliance Program description or this declaration, please contact us. To report compliance questions or potential compliance concerns, Vertos Medical encourages you to please contact our independent compliance division.

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