Compliancy & 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-Physici...

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-Physici...

- 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-Physici...

- AdvaMed Brochure for Physicians: A communication for physicians/dentists/orthodontists that provides more information about Open Payments from a partner and trusted source: http://advamed.org/res/60/brochure-for-physicians-on-the-sunshine-act

- 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/brochure-for-teaching-hospitals-on-the-sunshin...

KaVo Kerr Group's Comprehensive Compliance Program Declaration

Dental Technologies

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2016
The Dental Technologies companies (“Dental Technologies”) 1
are 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 Dental Technologies is
charged with the responsibility for safeguarding and strengthening that asset.

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

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

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

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

  1. Overview of Dental Technologies' Compliance Program
    1. Leadership and Structure

      Our Company Compliance Program has been developed by the Dental Technologies'
      Compliance Department. Our Company holds regular Compliance Committee meetings
      and is audited and monitored by a corporate compliance department.
    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 professional, 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 Helpline where employees and third
      parties can make such reports anonymously and without retaliation (https://www.danaherintegrity.com/).
    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.

1 Brands include Aribex, Gendex, KaVo, DCI Equipment, i-CAT, Marus,
DEXIS, Imaging Sciences International, Instrumentarium, PaloDEx, Pelton & Crane, and SOREDEX

Kerr Companies

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2016
Kerr Companies 2
are 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 Companies are
charged with the responsibility for safeguarding and strengthening that asset.

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

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

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

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

  1. Overview of Kerr Companies' Compliance Program
    1. Leadership and Structure

      Our Company Compliance Program has been developed by the Kerr Companies'
      Compliance Department. Our Company holds regular Compliance Committee meetings
      and is audited and monitored by a corporate compliance department.
    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 professional, 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 Helpline where employees and third
      parties can make such reports anonymously and without retaliation (https://www.danaherintegrity.com/).
    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.

2 Brands include Kerr Restoratives, Kerr Endodontics, Kerr Rotary, Kerr TotalCare, and Kerr Prevention

Metrex

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2016
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.

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.
      Our Company holds regular Compliance Committee meetings and is audited and monitored
      by a corporate compliance department.
    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 professional, 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 Helpline where employees and third
      parties can make such reports anonymously and without retaliation (https://www.danaherintegrity.com/).
    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.

Orascoptic

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2016
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.

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.
      Our Company holds regular Compliance Committee meetings and is audited and monitored
      by a corporate compliance department.
    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 professional, 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 Helpline where employees and third
      parties can make such reports anonymously and without retaliation (https://www.danaherintegrity.com/).
    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.

Ormco

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2016
Ormco 3 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.

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.

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

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

  1. Overview of Ormco’s Compliance Program
    1. Leadership and Structure

      Our Company Compliance Program has been developed by the Ormco Compliance Department.
      Our Company holds regular Compliance Committee meetings and is audited and monitored
      by a corporate compliance department.
    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 professional, 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 Helpline where employees and third
      parties can make such reports anonymously and without retaliation (https://www.danaherintegrity.com/).
    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.

3 Brands include Allesee Orthodontic Appliances