Paragon BioTeck. Inc. (“Paragon”) aims to conduct our business in an ethical, fair, and lawful manner. We will treat patients, healthcare professionals, providers, government officials, shareholders and vendors with respect and integrity.
Paragon will conduct business in accordance with regulations and guidelines set forth by national, regional, governmental and pharmaceutical organizations that regulate and oversee our industry. It is our goal to meet or exceed all requirements to ensure the smooth operation of our business.
This information and compliance program in accordance with California Health and Safety Code sections 119400 – 119402, the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General (OIG) of the Department of Health and Human Services (April 2003) and the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals,” dated July 1, 2002, as the same may be amended from time to time. Our Compliance Program is one of the key components to make available our program for compliance with applicable federal and state laws and industry standards regulating the marketing and promotion of our products.Paragon BioTeck. Inc. (“Paragon”) has established a program to comply with applicable federal and state laws and industry standards relating to marketing and promotion of its products. Paragon’s senior management and the company’s governing body are committed to support all programs and to foster a culture that promotes the prevention, detection, and resolution of concerns, issues, or problems.
The information below represents the components of Paragon’s program for compliance with the standards regulating the marketing and promotion of its products.
II. OVERVIEW OF COMPLIANCE PROGRAM
1. Policies and Procedures
Educational Grants and Research Grants – Grants will be awarded in support of high quality activities and educational interventions and materials which demonstrate the potential to improve patient care and health outcomes. All grants are awarded at the sole discretion of Paragon. A realistic and comprehensive budget is to be used entirely for the cost of the grant-funded activities. Grants will be issued to support only the costs associated with the development, delivery or evaluation of the educational program, resources, or materials. Grants will not cover costs such as: travel, lodging or personal expenses for attendees: compensation for attendees; lavish venues; or other costs that are neither reasonable nor customary.
Charitable Contributions and Patient Assistance – Paragon will offer charitable contributions and patient assistance as appropriate to offer access to needed healthcare and support within the community. Each request will be reviewed based on need and access. Contributions and assistance are offered with no conditional expectations.
Travel Expense Reimbursement for CME, Promotional or Product Training Meetings – Paragon will not reimburse for travel and lodging expenses of attendees at promotional or educational programs. Paragon may reimburse attendees for reasonable travel and lodging expenses associated with attendance at product training meetings. Meetings will be conducted in locations that are conducive to the exchange of information such as educational or conference settings. Meetings may take place at company facilities, medical institutions, or other appropriate settings.
Business Meals – Paragon may occasionally offer a meal as part of an educational presentation or a business discussion. These activities would be geared to be informational and not intended as entertainment or recreational. Attendance of a guest or spouse is not permitted or reimbursed. Business meal expenses would be judged based on local area standards.
Provision of Educational and Practice-Related Items – Paragon or its representatives may provide patient or practice related items to its customers. Items need to be reasonable in value and related to conditions and practice of profession. Items can include medical texts and anatomical models. Items are not to be given with frequency and repetition.
Total Annual Dollar Limit for Meals, Educational Materials or Practice-Related Items and Expense Reimbursement for Product Training Meetings – Paragon or any designee acting on behalf of Paragon shall spend no more than the annual aggregate of $1,500 on any one healthcare provider in California.
Prohibiting Entertainment During Sales Activities – General entertainment, such as sporting events, golf outings, concerts, etc., for customers and clients is not permitted as part of Paragon’s sales activities.
According to California Health and Safety Code § 119402 (2) there are items that are exempt from the limits if that support is provided in a manner that conforms to the ”Compliance Program Guidance for Pharmaceutical manufacturers” and the “Code on Interactions with Health Care Professionals.” The items are drug samples given to physicians and healthcare professionals intended for free distribution to patients, financial support for continuing medical education forums, and financial support for health educational scholarships.
2. Assigned of Compliance
Paragon has established a Compliance Committee composed of members of the company’s management team to review and monitor all activities of Paragon employees and designated contractors. At minimum they will meet once per calendar quarter.
Paragon has an annual training for all employees to cover all guidelines within the compliance and ethics programs at Paragon. Employees are also informed on the consequences of the failure to comply with the requirements of Paragon’s compliance and ethics programs.
Paragon encourages open and candid dialog between management and employees on all matters of company business including but not limited to compliance concerns. Employees are encouraged to utilize all resources to report their concerns or ask questions to their manger, to Human Resources or to any member of the Compliance Committee. All information will be kept confidential as appropriate.
5. Auditing and Monitoring
Paragon self-assesses and periodically audits its compliance with its current policies and procedures.
6. Enforcement and Disciplinary Guidelines
Paragon takes any violation to the company polices and procedures very seriously. Paragon will take appropriate disciplinary actions in response to such violations. Paragon will conduct a full and detailed investigation of matters that are brought to Paragon’s attention in order to ensure the consistent application of the company standards.
7. Responses to Detected Problems and Actions to Correct Issues
Paragon requires a thorough investigation in a timely manner in response to any potential violation of Paragon’s compliance, including its standards regulating the marketing and promotion of our products. Actions include but are not limited to revision or updating policies, reviewing procedures, training, communication, consistent monitoring or to require disciplinary action to prevent further or future violations.
III. DECLARATION FOR CALIFORNIA COMPLIANCE LAW
Paragon has developed its Comprehensive Compliance Program in accordance with California Health and Safety Code sections 119400 – 119402, the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General (OIG) of the Department of Health and Human Services (April 2003) and the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals,” dated July 1, 2002.
Paragon commits to constantly monitor and comply with applicable federal, state laws and industry standards relating to marketing and promotion of our products. To our knowledge as of the date of this declaration, Paragon is in compliance with our Comprehensive Compliance Program in accordance with California Health and Safety Code sections 119400 – 119402.
Copies of the Comprehensive Compliance Program may be obtained by calling Paragon toll-free at 1-888-424-1192.
