Monitor Mask, Inc. conducts its business in accordance with a comprehensive compliance program, and has made reasonable, good faith efforts to make its compliance program conform to the applicable requirements California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400-119402 (the “Statute”), as in effect on June 30, 2018. To the best of our knowledge, Monitor Mask, Inc. is in compliance in all material respects with the requirements of the Statute and AdvaMed Code, based on our good faith understanding of the requirements thereof as applicable to medical device manufacturers.
The Statute requires that we establish a specific maximum annual dollar limit on gifts, promotional materials, or items or activities that we may give or otherwise provide to an individual California medical professional. Our policies prohibit the provision of gifts, entertainment and/or recreational activities to any U.S. medical professional. With respect to educational items, product literature and related items from us, our limit is less than $500 per individual. This dollar limit does not include product samples of our medical devices intended for testing and/or free distribution to patients or payments made for legitimate professional services provided by a California medical professional. Consistent with the AdvaMed Code, this dollar limit also does not include plant visits to observe our quality production facilities, training on the safe and effective uses of our medical devices consistent with approved uses, which for many products is required by the U.S. Food and Drug Administration and/or to help medical providers provide better patient care.
In conjunction with this declaration please note that, from time to time, through audits, our disclosure program, or otherwise, Monitor Mask, Inc. may identify potential or actual violations of provisions of our compliance programs. In those instances, Monitor Mask, Inc. promptly investigates and responds appropriately to any violations consistent with our policies addressing noncompliance or misconduct.