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California 2024 Compliance Policy and Declaration 


As part of ROUTE 92 MEDICAL, Inc. (“ROUTE 92 MEDICAL” or “Company”) ongoing efforts in the area  of compliance, we have developed a Comprehensive Compliance Program that is designed to comply  with applicable federal and state laws and industry standards relating to the marketing and promotion of  our products. To our knowledge as of the date of this declaration, Route 92 Medical is in compliance with  our Comprehensive Compliance Program, as described here, and with California Health & Safety Code  sections 119400-119402. 

Copies of our Comprehensive Compliance Program (“CCP”) and our prior year Annual Declaration of  Compliance can be obtained by calling us at 650-581-1179 or emailing us at [email protected]

Last updated: February 28, 2024 


ROUTE 92 MEDICAL has established a program designed to comply with applicable federal and state  laws and industry standards relating to the marketing and promotion of its products. Additionally, ROUTE  92 MEDICAL recognizes that adherence to these standards can be furthered through a compliance  program that is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers,  published by the Office of Inspector General of the U.S. Department of Health and Human Services (the  “OIG Guidance”). The OIG Guidance advises that effective compliance programs are comprised of seven  elements, which are outlined below. As described below, these elements form the basis of ROUTE 92  MEDICAL program for compliance with the standards regulating the marketing and promotion of its  products. In addition, ROUTE 92 MEDICAL has implemented and maintains a website ( and  a compliance hotline to facilitate communication and requests for information related to California State  requirements. 

Written Policies and Procedures 

ROUTE 92 MEDICAL has written policies and procedures to assure substantial compliance with the  applicable laws, regulations and standards governing the marketing and promotion of our  products. ROUTE 92 MEDICAL follows the AdvaMed Code of Ethics on Interactions with Health Care  Professionals (“AdvaMed Code”). ROUTE 92 MEDICAL has established written policies and procedures  that govern activities involving communicating with health care professionals about the appropriate use of  our products, including appropriate instruction and education required for the safe and effective use of our  products. ROUTE 92 MEDICAL also has policies and procedures governing activities involving the  advancement of scientific and educational activities supporting medical research and education. These  policies and procedures include: 

Policy on Travel Expense Reimbursement for CME, Promotional or Product Training Meetings ROUTE 92 MEDICAL may reimburse attendees for their reasonable travel and lodging expenses  associated with attendance at training meetings conducted by ROUTE 92 MEDICAL. Training meetings  will be conducted in locations conducive to the exchange of information such as educational or  conference settings. Where face-to- face health care professionals training is reasonably necessary for  the safe and effective use of ROUTE 92 MEDICAL products, ROUTE 92 MEDICAL may provide training  at ROUTE 92 MEDICAL facilities, at independent teaching centers such as medical institutions, or in  other appropriate clinical settings. 

Policy on Business Meals 

ROUTE 92 MEDICAL may occasionally offer a modest meal as part of an educational presentation or a  business discussion. Entertainment or recreation at such meetings is not permitted. Attendance by  spouses or guests at such meetings is not permitted unless the spouse or guest has a bona fide reason  for attending, e.g., they are a health care professional interested in the use of a ROUTE 92  MEDICAL product.

Policy on the Provision of Educational and Practice-Related Items 

Subject to approval from the ROUTE 92 MEDICAL Compliance Officer, ROUTE 92 MEDICAL  representatives may provide items that benefit patients or serve a genuine educational function for health  care professionals. 

Total Annual Dollar Limit for California Health Care Professionals  

ROUTE 92 MEDICAL has established an annual limit for meals and educational items that may be  provided to California health care professionals pursuant to the requirements of Cal. Health & Safety  Code § 119402 (S.B. 1765). 

Policy Prohibiting Entertainment 

It is the policy of ROUTE 92 MEDICAL not to provide entertainment (e.g. sporting events, golf outings,  concerts, etc.) to health care professionals. 

Assigned Compliance Officer 

ROUTE 92 MEDICAL has a Compliance Officer. Our Compliance Officer is empowered with appropriate  authority to exercise independent judgment and has free and unencumbered access to senior  management and board of directors. ROUTE 92 MEDICAL has a Compliance Committee. The  committee is comprised of the Company’s Compliance Officer and members of the Company’s  management team. 


ROUTE 92 MEDICAL has an annual Compliance Training process. New employees receive training at  the time of hire and sales and marketing employees receive training annually thereafter. The training  covers applicable guidelines governing our compliance program. Employees are trained on the  consequences of failure to comply with the requirements of the Company’s compliance program. 


ROUTE 92 MEDICAL encourages open and candid discussion between management and employees  regarding any compliance concern. ROUTE 92 MEDICAL employees are encouraged to report their  concerns to their manager or to the Compliance Officer. Employees also have the option to report  potential violations anonymously using the ROUTE 92 MEDICAL Compliance Hotline. 

Auditing and Monitoring 

ROUTE 92 MEDICAL monitors and periodically audits its compliance with its policies and procedures. 

Enforcement and Disciplinary Guidelines 

ROUTE 92 MEDICAL may take disciplinary action, up to and including discharge/termination, in response  to violation of the Company’s compliance policies or procedures. ROUTE 92 MEDICAL may conduct an  investigation of matters that are brought to the Company’s attention in order to ensure the consistent  application of the Company’s standards. 

Responses to Detected Problems and Actions to Correct Issues 

ROUTE 92 MEDICAL requires a prompt and diligent response to potential violations of the Company’s  compliance program, including its standards regulating the marketing and promotion of our products.  Actions in response to detected problems may include improving policies, procedures, training,  communication and monitoring or may require disciplinary action to prevent future violations. 

San Mateo, California, United States of America
Original Date of Issue: 2024-02-28