California Compliance Statement
Statement regarding compliance with California Health & Safety Code §119402
Pursuant to California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”), which requires the adoption of a comprehensive 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”).
Covis Pharma US, Inc. and its applicable affiliates(“Covis”) has established a Healthcare Compliance Program in accordance with the OIG Compliance Program Guidance and has policies in place to foster compliance with government and applicable industry code requirements and expectations. Consistent with the requirements of the California Compliance Law and as part of the Healthcare Compliance Program, Covis has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that Covis may give or otherwise provide to an individual medical or healthcare 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 other healthcare professionals intended for free distribution to patients.
The items and activities covered by the law and Covis 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 Covis website. This limit represents a spending maximum, and the amount spent per medical, or healthcare professional may be significantly less than the maximum amount. Covis 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 (July 2023)
Every day, we at Covis strive to operate with integrity and honesty and provide quality products as part of our commitment to our patients, customers, suppliers, and other stakeholders. Our reputation remains our most valuable asset. To protect this asset, it is the policy of Covis that all interactions with medical and healthcare professionals and organizations that are made on behalf of Covis are consistent with ethical business practices and socially responsible industry conduct. Covis 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 Covis personnel and agents.
To the best of its knowledge and based on a good faith understanding of the statutory requirements, Covis has established a Healthcare Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. Covis has tailored its Healthcare Compliance Program to meet the specific needs of Covis and continuously assesses the effectiveness of the Healthcare Compliance Program. Our company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and other similar spend limits across the United States. Therefore, subject to the limitations described above, Covis declares that, based upon current tracking and monitoring systems, Covis is materially in compliance with its Healthcare Compliance Program and applicable law, including the established annual spending limits in California.
For a written copy of Covis’ Healthcare Compliance Program description or this declaration, please contact Covis’ Compliance Department at [email protected].
Covis has established the Covis Compliance Hotline as a way for Covis employees and external stakeholders to report a suspected misconduct or compliance concern. If any employee or person working on behalf of Covis has a good faith belief that a Covis employee or third party has done, is doing, or may be about to do something that violates the Covis Code of Conduct (as amended from time to time) or policies, procedures, local or international laws, regulations, and industry codes, they are encouraged to speak up by clicking the link or, to call 1-844-985-4105 from the United States and Canada or 0-800-890011 internationally.
In addition to the Covis Compliance Hotline, any compliance-related questions or concerns also can be sent to our Compliance Department at [email protected].