Compliance & Transparency

KAVO KERR GROUP'S STATEMENT OF COMPLIANCE WITH THE FEDERAL
PHYSICIAN SUNSHINE ACT

The Open Payments/Physician Payments Sunshine Act (“Open Payments”) was signed into law as part of the Affordable Care Act in March 2010. Official guidance on this law can be found on the Centers for Medicare and Medicaid Services (“CMS”) website http://go.cms.gov/openpayments For your convenience, the following was prepared from the official materials published by CMS and does not constitute legal advice.

What is Open Payments (Physician Payment Sunshine Provision)?

Section 6002 of the Federal Affordable Care Act includes the establishment of a transparency program, known as the National Physician Payment Transparency Program (commonly referred to as the Sunshine Act but officially referred to as “Open Payments”). Open Payments requires applicable manufacturers to report annually to CMS certain payments and other transfers of value provided to covered recipients.


Who is a “covered recipient” under Open Payments?

A covered recipient is defined as a physician or teaching hospital. Physician includes doctors of medicine and osteopathy, dentists, dental surgeons, podiatrists, optometrists and chiropractors with an active state license – whether or not they are currently treating patients. Medical residents, students, nurse practitioners and pharmacists are not considered covered recipients.

CMS has committed to publishing a list of teaching hospitals annually. The current list of teaching hospitals can be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Teaching-Hospitals.html


What transfers of value are reportable under Open Payments?

Beginning August 1, 2013, payments made to covered recipients, both directly and indirectly, must be captured and eventually reported to CMS. Reportable payments or transfers of value include, but are not limited to: consulting fees; speaker fees; honoraria and other compensation; gifts; entertainment; food and drinks; travel; lodging reimbursement; educational materials for physician use; research; clinical trial and grant payments; royalty or license payments; charitable contributions made on behalf of a Covered Recipient; fees paid to Teaching Hospitals; and current or prospective ownership or investment interest.


Who is responsible for reporting information under Open Payments to CMS?

Applicable manufacturers (engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply having a physical office in or conducting actives in the United States, or in a territory, possession, or commonwealth of the United States or under common ownership and which provides assistance or support to such entity) of covered products (drugs, devices, biologicals, and medical supplies that are reimbursed or reimbursable under Medicare/Medicaid/CHIP and that require FDA approval, licensure, or clearance) are required to report information to CMS.

Dealers and resellers that take title to a covered product are also generally responsible to report transfers of value under Open Payments.


When are the first reports due to CMS?

On March 31, 2014, aggregate spend reports are due from applicable manufacturers to CMS for the period of August 1 through December 31, 2013. In May, 2014, detailed spend reports are due from applicable manufacturers to CMS for the same time period. These payments will then be made available on a public, searchable website published by CMS on or around September 30, 2014.


Will Covered Recipients have the opportunity to review reported payments made to them?

Yes, Covered Recipients will be able to review any reportable information before the data is made public, and to dispute any data they believe to be inaccurate. CMS is providing a 45-day review and correction period, during which covered recipients may register and then sign into the CMS secure website and review the data submitted by applicable manufacturers on their behalf and choose to dispute certain payments or other transfers of value. As soon as a dispute is initiated, applicable manufacturers may begin resolving the dispute and correcting the data. Following the end of the review and correction period, applicable manufacturers will have an additional 15 days to correct data for purposes of resolving disputes. Undisputed data will be finalized for publication after the close of the annual 45-day review and correction period. The correction and review period will begin no later than August 1, 2014.


What is our company doing to help with the review process?

We are tracking all applicable payments and transfers of value to physicians and teaching hospitals. In order to provide a correct representation of our physicians as well as our company, it is imperative that this data be accurate. Therefore, we are working to create an internal system in which covered recipients can communicate directly with our businesses to confirm or dispute any transactions. Additional information will be provided when this system is live.


Where can additional information be found?

We encourage all healthcare professionals to familiarize themselves with Open Payments and to register with CMS in order to receive updates regarding the program. The link to register with CMS is http://go.cms.gov/openpayments.


Where can I find more information about Open Payments?

Below are some additional reference materials for your convenience:

-Open Payments Final Rule from CMS: The document can be found at
http://go.cms.gov/openpayments

- Frequently Asked Questions: CMS maintained FAQ document pertaining to Open Payments. The document can be found at http://go.cms.gov/openpayments

- CMS Physician Fact Sheet: A summary of Open Payments for physicians directly from the Centers for Medicare and Medicaid Services (CMS), the regulatory agency responsible for implementing this law. The document can be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Physicians.html

- CMS Teaching Hospital Fact Sheet: A summary of Open Payments for teaching hospitals directly from CMS. The document can be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Teaching-Hospitals.html

- AdvaMed Brochure for Physicians: A communication for physicians/dentists/orthodontists that provides more information about Open Payments from a partner and trusted source: https://advamed.box.com/sunshinebrochure-phys-pdf

- AdvaMed Brochure for Teaching Hospitals:A communication for hospitals that provides more information about Open Payments from a partner and trusted source: http://advamed.org/res/61/physician-payments-sunshine-law-brochure-for-teaching-hospitals-spread8-5x14


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


KAVO KERR GROUP'S COMPERHENSIVE
COMPLIANCE PROGRAM DECLARATIONS BY BRAND
COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Allesee Orthodontic Appliances 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 Allesee Orthodontic Appliances is charged with the responsibility for safeguarding and strengthening that asset.

Allesee Orthodontic Appliances 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.

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

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

  1. Overview of Allesee Orthodontic Appliances’ Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Allesee Orthodontic Appliances Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Aribex 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 Aribex is charged with the responsibility for safeguarding and strengthening that asset.

Aribex 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.

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

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

  1. Overview of Aribex’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Aribex Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.

    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION 
July 1, 2013
Axis|SybronEndo 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 Axis|SybronEndo is charged with the responsibility for safeguarding and strengthening that asset.

Axis|SybronEndo 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.

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

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

  1. Overview of Axis|SybronEndo’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Axis|SybronEndo Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $2,500 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.

    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
DCI Equipment 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 DCI Equipment is charged with the responsibility for safeguarding and strengthening that asset.

DCI Equipment 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.

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

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

  1. Overview of DCI Equipment’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the DCI Equipment Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.

    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
DEXIS 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 DEXIS is charged with the responsibility for safeguarding and strengthening that asset.

DEXIS 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.

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

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

  1. Overview of DEXIS’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Dexis Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Gendex 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 Gendex is charged with the responsibility for safeguarding and strengthening that asset.

Gendex 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.

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

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

  1. Overview of Gendex’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Gendex Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
i-CAT 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 i-CAT is charged with the responsibility for safeguarding and strengthening that asset.

i-CAT 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.

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

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

  1. Overview of i-CAT’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the i-CAT Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.

    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Imaging Sciences International 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 Imaging Sciences International is charged with the responsibility for safeguarding and strengthening that asset.

Imaging Sciences International 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.

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

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

  1. Overview of Imaging Sciences International’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Imaging Sciences International Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
KaVo 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 KaVo is charged with the responsibility for safeguarding and strengthening that asset.

KaVo 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.

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

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

  1. Overview of KaVo’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the KaVo Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Kerr 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 Kerr is charged with the responsibility for safeguarding and strengthening that asset.

Kerr 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.

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

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

  1. Overview of Kerr’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Kerr Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Kerr TotalCare 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 Kerr TotalCare is charged with the responsibility for safeguarding and strengthening that asset.

Kerr TotalCare 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.

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

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

  1. Overview of Kerr TotalCare’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Kerr TotalCare Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $1,500 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.

    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Marus 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 Marus is charged with the responsibility for safeguarding and strengthening that asset.

Marus 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.

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

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

  1. Overview of Marus’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Marus Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Metrex 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 Metrex is charged with the responsibility for safeguarding and strengthening that asset.

Metrex 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.

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

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

  1. Overview of Metrex’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Metrex Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $1,500 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Orascoptic 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 Orascoptic is charged with the responsibility for safeguarding and strengthening that asset.

Orascoptic 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.

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

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

  1. Overview of Orascoptic’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Orascoptic Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $1,500 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Ormco 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 Ormco is charged with the responsibility for safeguarding and strengthening that asset.

Ormco 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.

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

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

  1. Overview of Ormco’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Ormco Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
PaloDEx/Instrumentarium 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 PaloDEx/Instrumentarium is charged with the responsibility for safeguarding and strengthening that asset.

PaloDEx/Instrumentarium 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.

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

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

  1. Overview of PaloDEx/Instrumentarium’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the PaloDEx/Instrumentarium Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Pelton & Crane 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 Pelton & Crane is charged with the responsibility for safeguarding and strengthening that asset.

Pelton & Crane 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.

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

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

  1. Overview of Pelton & Crane’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Pelton & Crane Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

      Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.
    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.

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


COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2013
Sorodex 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 Sorodex is charged with the responsibility for safeguarding and strengthening that asset.

Sorodex 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.

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

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

  1. Overview of Sorodex’s Compliance Program
    1. Leadership and Structure
      Our Company Compliance Program has been developed by the Sorodex Compliance Department, and is managed by the President/Chief Compliance Officer (CCO). Our President leads the Company’s Compliance Committee, which meets on a quarterly basis.
    1. 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.

Our Company has sales specialists located in California. Through those sales specialists, and otherwise, the company conducts promotional activities with California healthcare providers. The company has established a $5,000 annual limit on promotional spending per California medical and health professionals, which includes persons licensed by California to prescribe prescription products, medical students, and members of drug formulary committees.

    1. 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.
    1. 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 Hotline where employees and third parties can make such reports anonymously and without retaliation.
    1. 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.
    1. 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.
    1. 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.
A copy of our Company’s Compliance Program and this declaration may be obtained by calling 855-681-1978.

KaVo

Instruments | Treatment Units | CAD/CAM | Lab | Education | Imaging

KaVo is the global leading brand of progressive dental equipment and integrated workflow solutions. Driven by our dedication for excellence we are setting trends that empower our partners and inspire dental professionals.

Kerr

Consumables | Restorative Products

Since 1891, Kerr has been developing and manufacturing dental products and consumables that are used in every dental restorative procedure today. As we advance esthetic dentistry through education and sustainable solutions based on clinician input, the name Kerr has become synonymous with integrity for dental professionals worldwide.

DEXIS

2D Intra-oral Imaging | Software

DEXIS is for every dentist forever. DEXIS delivers innovative, high-quality digital imaging solutions to the dental community. The DEXIS Platinum Digital X-ray System, with its technologically advanced intra-oral sensor and intuitive, easy-to-use imaging software, provides numerous benefits to doctors, practices and patients.

Axis

Rotary Instruments

Axis Dental remains at the forefront of the rapidly changing field of dentistry, as a distributor of logic sets, organization systems, endodontic products, and NTI® Rotary Instruments, our commitment to innovative, quality products and efficiency within the dental practice has been key to the company’s continued success.





SybronEndo

Rotary Instruments

SybronEndo has been an endodontic innovator for more than 100 years and we are constantly developing new dental supplies and techniques to improve and compliment the practice of endodontics. Our founding company, Kerr Endo, was the first manufacturer of endodontic instruments and dental supplies in the world, and the K in K-file was named after Kerr. Many great companies and endodontic industry leaders have come together to make SybronEndo what we are today: a leader in quality endodontic products.

Gendex

Intra-oral/Extra-oral 2D/3D Imaging | Software

Gendex is always by your side. We design dependable and innovative imaging solutions that provide vital information to support accurate diagnosis and predictable treatment planning. From our earliest days, Gendex has stood by the side of general practitioners and specialists, providing comprehensive imaging solutions to advance the quality of dental health care.

i-CAT

3D Cone Beam Imaging System

i-CAT is the most comprehensive 3D treatment solution from the most trusted 3D imaging brand. The i-CAT philosophy is Scan, Plan and Treat featuring clinical control and optimized patient care, comprehensive treatment tools and confidence to treat with greater predictability. Widely recognized as the industry standard in cone beam technology, i-CAT solutions have been installed in more than 3000 sites around the world.

Instrumentarium Dental

2D & 3D Imaging | Software

For the past 50 years, Instrumentarium has been pioneering imaging systems designed for professionals. The Instrumentarium product portfolio consists of a full range of premium quality imaging solutions for intra-oral, extra-oral and 3D imaging.

Kerr TotalCare

Prophylaxis and Infection Control Products

At Kerr TotalCare, we're all about advancing hygiene and empowering people. We are for hygienists and dental professionals worldwide dedicated to improving patient health. Kerr TotalCare is the trusted partner that delivers innovative solutions across the hygienist’s workflow to empower and inspire them to deliver the highest level of care to their patients.

Our trusted brands have protected over 100 Million people every year for more than 25 years. Kerr TotalCare products are sold through leading dental and medical product suppliers around the globe

Nomad by Aribex

Portable Imaging

The family of Aribex NOMAD Dental x-ray systems are the most advanced intraoral dental x-ray machines on the market for dental professionals. The dental x-ray handheld design improves dental radiography speed, convenience, and quality. Aribex offers two products for dental x ray device applications, the NOMAD and NOMAD Pro handheld x-ray systems.

Orascoptic

Loupes | Headlights | Diagnostic

Founded by a dentist in 1981, Orascoptic assists clinicians in delivering better procedural outcomes through superior visualization. We do this by providing magnification with the best resolution, across the widest and through the deepest field of view. We remain committed to establishing enduring customer relationships and our goal is to have customers for life – from residency to retirement.

Ormco

Orthodontic Products and Solutions

For over 50 years, Ormco has partnered with the orthodontic community to manufacture innovative products and solutions to enhance the lives of our customers and their patients. From traditional brackets and wires to advanced digital treatment solutions and educational support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives.

Pelton & Crane

Treatment Units | Cabinetry | Sterilization

Pelton & Crane is your image reflected. We create clinical environments that reflect the standard of care that fits dentists needs and aspirations. Combining a relentless pursuit of continuous improvement and attention to clinical needs, Pelton & Crane delivers ergonomically optimized and aesthetically pleasing environments with award winning chairs, delivery units, lights, cabinetry, and sterilization solutions.

Pentron

Composites | Bonding | Cements | Posts

Since 1967, Pentron has created technologically advanced products that enhance the practice of dentistry. With a focus on post and core, impression materials, composites and bonding agents, Pentron has established a loyal customer following.

SOREDEX

2D & 3D Imaging | Software

SOREDEX has been a leader in providing innovative imaging solutions for demanding professionals. Through continuous evolution and refinement, SOREDEX has set the highest industry standards for quality, reliability and efficiency.

Marus

Treatment Units

Marus is “Practical in Practice”. We are all about delivering practical and reliable solutions. By focusing on the things that matter and with a strong commitment to craftsmanship, Marus delivers simple, reliable, and affordable operatory solutions that ensure dependable dental office operation.

DCI Equipment

Chairs | Lights | Treatment Units

DCI Equipment is handcrafted to be the finest equipment for the value-minded dental professional. DCI offers unmatched features and quality at an affordable price. DCI - Simplicity in action.

Implant Direct

Dental Implant Products

Implant Direct has a 29 year history of innovation in the dental implant industry. Implant Direct's philosophy has always been to provide high quality, innovative dental implants at cost-effective prices. It started with the Core-Vent implant system in 1982, launching the concept of simplified surgical procedures and versatile prosthetic application. In 1986, the self-tapping *Screw-Vent Implant with its internal hex-thread connection was invented and considered to be the cornerstone for modern dental implant designs. Then, in 1997 came the Tapered *Screw-Vent for two-stage surgery and the Tapered *Advent for one-stage surgery, both with the same body design and dimensions allowing insertion with the same set of surgical instruments. In all, Implant Direct has developed a spectrum of seven application specific implants, all with the same body design and dimensions.