Ethics & Compliance Program
Nihon Kohden North America, Inc., and its Subsidiaries (collectively, “NKNA” or “the Company”) follow the principles set forth in the Code of Ethics & Conduct, in the Policies and Procedures, and in the Corporate Values, of its Japan-based parent, Nihon Kohden Corporation (“NKC”).
Among other things, the Nihon Kohden Group Global Compliance Program includes Board of Directors oversight; a Global Chief Compliance Officer; a cross-functional Compliance Committee; a Global Compliance Handbook; a Charter of Conduct; a Code of Ethics and Conduct; and various Policies and Procedures relating to Ethics and Compliance.
Within the North American market specifically, NKNA employs an Ethics & Compliance Program designed around the requirements of the United States Sentencing Guidelines (“USSG”), of the United States Department of Justice (“USDOJ”), and of the Department of Health and Human Services - Office of the Inspector General (“HHS-OIG”) with respect to Medical Device companies.
This Program is intended to ensure that all Company Directors, Executives, Employees, and Agents uphold the highest standards of honesty and integrity that the Nihon Kohden Group expects of all of its personnel and that they act in full compliance with all laws, regulations, and codes that apply to Nihon Kohden’s business.
In North America, a Chief Legal and Compliance Officer leads and manages the local Compliance Program, including Risk Assessment; Policy and Procedure; Education, Training, and Communication; Confidential Investigations and Reporting; Disciplinary Incentives and Disincentives; Monitoring and Auditing; Third-Party Due Diligence; and Program Assessment and Effectiveness.
Code of Ethics and Conduct
The principles by which all Nihon Kohden employees and agents conduct themselves are found in the NKC Code of Ethics and Conduct, available here: https://www.nihonkohden.com/sustainability/nk_sustainability/policy/main/00/teaserItems1/02/linkList/02/link/conduct.pdf.
These principles, both aspirational and inspirational, align with and support NKC’s Corporate Values, available here: https://www.nihonkohden.com/sustainability/governance/compliance.html.
Ethics Helpline
In order to help foster an ethical culture and to encourage Employees to “speak up” when they have a question, concern, or complaint, NKNA provides an “Ethics Helpline” for both open and anonymous reporting.
Employees, Agents, and external parties may reach the Ethics Helpline in the following ways:
• Online Web Portal at https://www.nkhelpline.com
• Toll-Free Telephone Helpline: +1-866-440-3672
Sponsorships, Grants, and Donations
Overview of the Program
As a leading global manufacturer of cutting-edge medical devices, NKC is committed to supporting: (1) the advancement of medical education; (2) the enhancement of patient care; (3) public education on relevant health care topics; and (4) other bona fide charitable endeavors that are consistent with the Company’s mission.
In keeping with this commitment, NKNA welcome applications for support from Health Care Organizations (“HCOs”) – and from Health Care Professionals (“HCPs”) seeking to conduct Clinical Research – through NKNA’s Sponsorships, Grants, and Donations Program (“the Program”), as described herein. Examples of HCOs and HCPs qualified to request such support include:
- Academic/Teaching Hospitals, Medical Schools, and Medical Foundations;
- Health Care Professional Organizations, Associations, and Societies;
- Health Care-Related 501(c)(3) (Tax-Exempt) Organizations; and
- HCP Principal Investigators, in connection with Clinical Research at an HCO Site.
The specific types of funding available through the Program are as follows:
- Commercial Sponsorships for Medical, Scientific, Technical, and Policymaking Conferences, Meetings, Symposia, and Congresses;
- Educational Grants for the Advancement of Medical Education;
- Clinical Research Grants; and
- Charitable Donations, including those supporting
- Public Education;
- Patient Education;
- Indigent Care; and
- Bona Fide Local Community Charitable Endeavors
General Program Funding Guidelines
Limited Funding Resources: Please understand that NKNA receives many worthy funding requests but has only limited resources to devote to this purpose. As such, NKNA cannot provide funding to every Applicant, however meritorious the request.
Time Limitation on Requests: In order for NKNA to consider any Application for funding, NKNA must receive the Application at least 90 days before the Applicant needs a decision on the request (i.e., the “Funding Decision Date”).
Specified Funding Criteria and Supporting Documents: Please further understand that NKNA can support funding requests only where Applicants meet all of NKNA’s established criteria set forth, and provide all documents required, in each Application Form.
Proper Purposes Only: NKNA is committed to conducting its business with the utmost ethics and integrity. As such, NKNA will never award a Sponsorship, Grant, or Donation based on past or possible future purchases, uses, orders, or recommendations of Nihon Kohden products. Indeed, NKNA conducts its Program in accordance with guidance from the ACCME Standards for Commercial Support; the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (United States); the MEDEC Code of Conduct (Canada); and related Nihon Kohden policies and procedures. In furtherance of this commitment, the Company will not consider Educational Grants or Charitable Donations to an HCO while a potential commercial deal is pending between any NKNA Subsidiary and the HCO Grant/Donation requester or its affiliates.
Transparency Reporting: NKNA will report all “transfers of value” to any HCO or HCP – including the payment of Commercial Sponsorship, Clinical Research, Educational Grant, and Charitable Donation funds – to the U.S. Government (Centers for Medicare and Medicaid Studies) and to any relevant State Government, as law or regulation may require.
No Gifts, Entertainment, or Recreation: Under no circumstances will NKNA consider funding requests for any gift or for any entertainment or recreational activities (e.g., golf outings, theater, sporting events, or any event where entertainment or recreation is a significant focus) for any HCO or HCP.
Procedure for Requesting NKNA Funding
External parties wishing to apply for a Commercial Sponsorship, Clinical Research Grant, Educational Grant, or Charitable Donation must comply with the following Procedure:
- Complete an Application: Applications for all third-party funding requests reside on NKNA’s public website, from which the Applicant must obtain the relevant Application. NKNA will not accept any other form of Application, including outdated (“non-current”) Forms. Applicants must compete the relevant form fully and accurately before submission to NKNA, including the “Applicant Checklist” on the first page of each Application Form.
- Collect Required Materials: External parties must also carefully review the relevant Application and collect all Supporting Documents that the Application requires (as stated in the Application). NKNA will not approve Applications that are missing required documentation.
- Submit the Application: Upon completion and execution of the relevant Application, external parties must submit the Form, and all Supporting Documents, to the NKNA Ethics & Compliance Department at Ethics&Compliance@NihonKohden.com, or directly through the NK Website (should that option be available).
Permissible Types of Funding Requests
- Advancement of Medical Education for HCPs
NKNA understands the importance of, and need for, highly trained medical professionals who can provide quality patient care in a broad range of settings – including interventional, pre-operative, post-operative, and clinical care – and is committed to providing support for the advancement of medical education in these areas.
As such, NKNA supports the continuing education of HCPs in the areas of Patient Monitoring (including Neurological and Cardiological Monitoring), Respiratory Care, Sleep Science, and Digital Health Solutions. Within these areas, NKNA will consider supporting bona fide, independent educational, scientific, technical, or policymaking events and activities that promote scientific knowledge, medical advances, and the delivery of efficient, effective health care.
- Commercial Sponsorships: In order to qualify as a “Commercial Sponsorship,” the funding request must provide NKNA with a “Fair Market Value” commercial benefit in exchange for its funding support. Where such benefits are not offered, the request must be one for an Educational Grant (see A.2., below).
To request a Commercial Sponsorship, click here Commercial Sponsorship Application Link, and follow the directions on the Application.
- Educational Grants: As noted above, where Fair Market Value commercial benefits are not offered, the request must be one for an Educational Grant.
To request an Educational Grant, click here Educational Grant Application Link, and follow the directions on the Application.
- Clinical Research Grants
NKNA has a strong interest in supporting research that provides valuable scientific and clinical information, improves clinical care, leads to promising new treatments, and promotes improved delivery of health care. As such, NKNA will consider supporting independent medical research that has well-defined objectives relevant to Nihon Kohden’s products and services, as set forth above.
To request a Clinical Research Grant, click here Clinical Research Grant Application Link, and follow the directions on the Application.
- Charitable Donations to Health Care Organizations (HCOs)
NKNA will accept Applications for relevant Charitable Donations directly from Tax-Exempt (e.g., 501(c)(3)) HCOs but not from individual HCPs or from any person or entity submitting the request on behalf of another person or entity.
To request a Charitable Donation, click here Charitable Donation Application Link, and follow the directions on the Application.
General Corporate Giving
NKNA is also proud to support non-HCP organizations (non-HCOs) that work to strengthen our local communities. Through the efforts of our Employee volunteers and our financial contributions, we share our success with our communities by giving back to not-for-profit organizations that address vital social needs, consistent with Nihon Kohden’s Corporate Giving Priorities. As a general proposition, such Priorities include providing modest-dollar, high-impact donations to charitable organizations in the immediate vicinity of NKNA offices and facilities, for the immediate benefit and betterment of groups of individuals in need.
If you are a non-HCP non-profit organization that wishes to apply for General Corporate Giving, please follow the same process for HCO-related Charitable Donations, as set forth above.
For any questions regarding NKNA’s Sponsorships, Grants, and Donations Program, please contact NKNA’s Ethics & Compliance Department at:
NKNA Ethics & Compliance Department
Nihon Kohden North America, Inc.
15615 Alton Parkway, Suite 150
Irvine, California, 92618
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