COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION

Nobel Biocare is committed to doing business in accordance with the highest standards of business conduct and ethics. We consider our reputation for ethical and compliant behavior to be a valuable corporate asset. Each employee of Nobel Biocare is charged with the responsibility for safeguarding and strengthening that asset.

Nobel Biocare is dedicated to complying with U.S. federal and state laws and regulations that place certain restrictions and reporting requirements on interactions the Company has with U.S. health care professionals and related organizations. Most notably, the Federal Physician Payment Sunshine Act requires the Company to annually report to the U.S. Centers for Medicare and Medicaid Services information about payments and other transfers of value that are provided to U.S. physicians and teaching hospitals. Payment types that are subject to reporting under this transparency law include, but are not limited to consulting fees, meals, travel, charitable donations, payments related to clinical trials and research, and physician educational materials, The Company is committed to fulfilling its obligations to track and report these payments and transfers of value as required by U.S. law.

In addition to complying with its obligations under U.S. federal and state transparency laws, our Company has established a Compliance Program in accordance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400‐119402 (the “Statute”), based on our good faith understanding of the requirements of the Statute as it may apply to a dental/medical device manufacturer. Our Company has developed a Compliance Program consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers (which is expressly applicable to medical device manufacturers) published by the Office of Inspector General of the U.S. Department of Health and Human Services. Our Compliance Program is tailored to the size, organizational structure, nature of our business as a dental/medical device manufacturer, and resources of our Company. The medical device industry has established, and our Company’s Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”). The AdvaMed Code is a voluntary ethical code established by the medical device industry. It is substantially similar to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, but reflects the unique interactions between medical device manufacturers and health care professionals.

While adoption of appropriate policies does not necessarily guarantee that improper employee conduct will be entirely eliminated, it is our Company’s expectation that employees will comply with our Code of Conduct, healthcare compliance policies and other policies adopted in support of the AdvaMed Code. Furthermore, our Compliance Program has been designed to prevent and detect violations. In the event our Company becomes aware of potential violations of law or Company policy, the Company will, where appropriate, investigate the matter, take disciplinary action, and/or implement corrective measures to prevent future violations. This description of our Compliance Program reflects the plan we have implemented. We will periodically reassess the program to improve it, and may refine the elements as necessary. Our Company is committed to upholding the highest standards of business conduct and ethics in its relationships with customers, employees, shareholders, the business community, and state and federal governments.

Annual Description of Comprehensive Compliance Program
California Health & Safety Code §§ 119400-119402

I.   Overview of Nobel Biocare’s Compliance Program

A.  Leadership and Structure

Our Company Compliance Program has been developed by the Nobel Biocare Compliance Department. Our Company is regularly monitored by a corporate compliance department.

 

B.  Policies and Procedures
Our Company has enacted written policies and procedures implementing its high ethical standards and meeting its healthcare compliance obligations under applicable laws, regulations and industry codes of conduct. These policies apply to all Company employees and compliance with those policies is a condition of employment.

One such policy is the Danaher Code of Conduct, revised and updated in 2011. Each employee is required annually to certify that he/she has read, understands and agrees to comply with the Code of Conduct, and to disclose knowledge of any suspected or actual ethics or compliance issues, concerns or violations.

 

C.  Training and Education
We provide ethics and compliance training to all sales, marketing and research and development associates. We train on our Code of Conduct, company policies and applicable compliance laws, regulations and industry codes. We provide training to new employees, include compliance training in our initial sales training curriculum, and provide both annual and ad hoc compliance training as appropriate. We provide compliance guidance at company meetings and respond to compliance questions from employees.

 

D.  Compliance Communications
Our Company is committed to maintaining a work environment where all individuals encourage and embrace open discussion across both geographical and operational boundaries. Employees are encouraged to seek guidance in resolving ethics and compliance questions. They can do so directly with the Compliance Department. They are required to report suspected or actual unethical or non-compliant conduct, violations of law or regulation and violations of the Code of Conduct or Company policies. Access is provided to an independent, third-party operated, Compliance Helpline where employees and third parties can make such reports anonymously and without retaliation (https://www.danaherintegrity.com/).

 

E.  Auditing and Monitoring
Our Company performs compliance gap analyses, process reviews and data analysis to identify and address potential issues and opportunities to enhance its processes and practices. These are collaborative efforts between the Compliance Department and the business which have generated the development of new and revised policies, new training and communications initiatives and corrective action.

 

F.  Investigating and Responding to Potential Violations
Our Compliance Department monitors company functions and activities for potential violations of law, regulation, industry codes, the Code of Conduct and company policies. Potential violations are promptly and thoroughly investigated and appropriate corrective action taken.

 

G.  Corrective Action
In determining the appropriate response to an established violation, our Company considers various options for corrective action. These options include closing any gaps in policies, practices or training that may have led or contributed to the violation and the imposition of disciplinary action, up to and including termination.

II.   A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.