Code of Conduct and Ethics

Okami Medical’s Business Conduct Standards on Interactions with HealthCare Professionals

INTRODUCTION

Okami Medical recognizes that healthcare professionals (HCPs) are critical partners in our ability to fulfill our purpose.  We collaborate with HCPs to create new products and therapies and to improve existing products.  We provide training and education on the safe and effective use of our products to HCPs.  These interactions are for the ultimate benefit of our patients.

To meet our commitment to integrity and high ethical standards, we have a Comprehensive Compliance Program (“the Program”) designed to detect and prevent behaviors that could harm Okami Medical and the patients we serve.

In no instance will Okami Medical offer or provide a payment to an HCP as an unlawful inducement to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe a product.  We are committed to adhering to applicable laws regarding an HCP’s use of our products and respect their right to make independent medical decisions when treating patients.

Our marketing, medical education and promotional activities are consistent with these commitments, and we comply with governing laws regarding appropriate scientific, educational training and promotion of our products.  The Program is based on recognized state and federal laws and regulations, industry standards, best practices, and guidelines, for example, the Office of Inspector General’s Severn Elements of an Effective Compliance Program, for establishing an effective compliance program outlined as follows:

Leadership

Okami Medical has designated a Compliance Specialist to oversee the Program who reports directly to the Chief Executive Officer.

Written Policies

Our commitment to integrity, compliance and ethics is set forth in our policies and procedures that help us follow relevant laws, regulations, and industry codes and best practices.

Effective Lines of Communication

We promote an environment where employees can raise questions, concerns and/or ask for clarity without the fear of retaliation.  Employees can inquire or report instances of known or suspected non-compliance directly with their manager, Human Resources, or through the company’s Helpline.

Training and Education

We provide appropriate training to educate and help our employees meet their ethical and compliance obligations.

Accountability

Okami Medical supports ethical and compliant behavior and requires every individual to adhere to the policies in the Program as a condition of their employment. We support ethical behavior, evaluating it as part of annual performance reviews, promptly investigating reports of misconduct and, if necessary, timely disciplinary action against those who violate our policies and standards.

Assessment – Auditing and Monitoring

We conduct monitoring and auditing of the Program to evaluate its effectiveness.

Remediation

Results of investigations, audits and monitoring are communicated according to policies and procedures.  When an area for improvement is identified, we take appropriate corrective action.

Code of Conduct and Ethics for Interactions with Healthcare Professionals

It is the policy of Okami Medical, Inc. (“the Company”) that all directors, officers, and employees of the Company, as well as any consultants or vendors who work on behalf of the Company, comply with the Code of Conduct and Ethics for Interactions with Healthcare Professionals (“the Code”).

The Code does not provide an exhaustive discussion of the ethical and legal requirements we must adhere to; rather, it is intended to alert us of the common issues we may confront from time to time in conducting business. The Program includes policies and procedures that contain instructions.  Some of those policies and procedures are referenced in the Code, but employees are responsible for determining when a more specific policy or procedure applies.  If you have any doubt as to the lawfulness of any proposed activity, you should seek advice from your manager or Human Resources before such action is undertaken.

The laws that apply to compliance are complex, far-reaching, and occasionally overlap.  As a result, single acts of misconduct can raise issues under multiple statutes and jurisdictions.  Punishment can be severe, resulting in multi-million-dollar civil penalties and criminal convictions that involve major fines and, in some cases, imprisonment.  In addition, there are government sanctions that can potentially devastate an entire company, and all parties who engage in illegal activity may be held accountable.  This means that our HCP partners, along with our employees, can be prosecuted for violations.  In adhering to the Code, we are protecting our HCP partners, our company, our stakeholders, our patients, and ourselves.

The Code embodies standards to which all directors, officers, and employees are expected to adhere and advocate.  Violations of the Code may result in disciplinary action, up to and including termination of employment.

Employee Responsibilities

As an employee, you are expected to understand the Code and the company’s policies, abide by them, and raise any questions or concerns you may have. You are responsible for reporting perceived or actual wrongdoing should any occur.  If you know or suspect that a policy or law has been broken or the Code has been violated, report it promptly to your manager, Human Resources, or contact the Helpline via Lighthouse Services:

Website:  www.lighthouse-services.com/okamimedical

Toll-Free Telephone: 855.650.0005

Email: reports@lighthouse-services.com

Fax:  215.689.3885

Okami Medical will handle all inquiries discreetly and make every effort to maintain, within the limits allowed by law, the confidentiality of anyone requesting guidance or reporting actual or perceived misconduct or other matters of concern under the Code.

Ethical business conduct is part of everyone’s job.  We do not change our ethics because competitors may behave differently, or our financial goals aren’t met.  There are four questions you may ask yourself if you are approached with new situations, issues, questions, challenges, problems, or temptations while doing your work:

1. Will my action violate any laws or regulations?
2. Will my action violate any company policy or any provision of the Code?
3. Will I be proud of my action if seen by my co-workers, family, friends, regulators, or the media?
4. Will my action be honest, fair, and promote the values of Okami Medical?

Always feel free to discuss any issue with your manager.  We do not permit retaliation of any kind against employees for good faith reports of ethical violations.  In cases where it may not be appropriate or you feel uncomfortable discussing with your manager, you may discuss with Human Resources or contact the Helpline (Lighthouse Services) as indicated above.

If you report an issue or want to ask for clarity regarding a policy and wish to remain anonymous, your identity and the information you share will be provided on a “need to know” basis with those responsible for resolving the concern and/or issue.  You may remain anonymous as permitted by local law, however, if you identify yourself, we will be able to follow up with you for requests and/or provide feedback in a more timely manner.

No one will be punished for asking about possible breaches of law, regulations, or an Okami policy.  We absolutely prohibit retaliation against anyone who raises an issue or helps address a compliance matter in good faith. Any allegation of reprisal will be investigated, and corrective action taken.  It is our policy to protect those who do the right thing.

Management Responsibilities

If you supervise others, you have a responsibility to act and communicate in a manner that is consistent with the Code.  You may be held accountable if your employee breaks the law or violates our policies or the Code.  We rely on you to create a culture of compliance in which your employees understand their responsibilities and feel comfortable raising concerns without fear of retaliation. Encourage ethical conduct by personally leading compliance efforts, taking compliance into consideration when evaluating your employees, and reinforcing the importance of our compliance policies and the Code.  Help your team understand that results are never more important than conduct, that we must respond promptly and adequately to compliance questions and issues and attend compliance training when requested/required to do so.

Managers Lead by Example

Model ethical behavior and follow Okami Medical’s policies and procedures and the Code at all times.  Be proactive in addressing people, policies and procedures that may pose a compliance risk.  Educate your employees about key compliance issues and make yourself available to answer any questions about what is appropriate and what is not.

Maintain Accurate Books and Records

The Sunshine Act (a/k/a Transparency Reporting) is a federal law that requires accurate and timely annual submission of transfers of value to HCPs and Healthcare Organizations.  Carefully review expense reports you are responsible for, check requests and invoices that you approve for payment.  Tell your employees what you expect from them and maintain an open and trusting environment for them to share their questions and concerns. 

Reporting  Non-Compliance and Corrective Actions

Educate your employees about the reporting process stated above.  Make sure your team understands their responsibility to speak up if they see or suspect misconduct.  Do not investigate matters yourself.  Never respond to concerns in a retaliatory manner or allow retaliation by others.

Accountability

We require all employees to adhere to the Program and the Code as a condition of their employment.  We support ethical behavior, evaluating it as part of annual performance reviews, promptly investigating reports of misconduct and, if necessary, timely discipline against those who violate the laws, the Program, the Code, and other Okami policies and procedures as applicable.  Adjudication of non-compliance is managed by Human Resources in collaboration with others as appropriate.

Human Resources (and/or their assignees) is responsible for administering internal fact finding and investigations of suspected or actual violations. We will assign an investigator, including appropriate personnel within Okami Medical as well as outside legal counsel or the audit committee if appropriate and necessary.

Human Resources and/or others as assigned to administer fact finding and investigation will work to determine the facts and recommend corrective action. Whenever possible, the person who raised the concern will receive feedback.  You are expected to cooperate if called upon during any investigation.  Do not compromise the integrity of the investigative process, i.e., do not circumvent the policy and process and conduct your own investigation or fact-finding.

The company will use every reasonable effort to prevent conduct that violates the Code and to stop any misconduct as soon as it is discovered. Employees who fail to comply with laws or regulations governing our business, or who intentionally and/or repeatedly violate the spirit or letter of our policies are subject to disciplinary action up to and including termination of employment and, if warranted, legal proceedings.  Misconduct that may result in discipline includes, but is not limited to, the following:

• Committing – or directing someone else to commit – a violation of law or the Code
• Failing to promptly raise a known or suspected violation
• Failing to cooperate in fact finding or an investigation of possible violations
• Failing to tell the truth during an investigation
• Retaliating against anyone for speaking up in good faith

Medical Device Laws and Regulatory Requirements

We comply with applicable medical device laws and respect and adhere to our regulatory requirements.  Our products are heavily regulated by government agencies.  Regulatory requirements include marketing approvals, clinical study parameters, good manufacturing, design controls, and labeling and advertising controls, among others.

Although HCPs can lawfully prescribe or use products for unapproved (off-label) indications, Okami Medical is restricted in how we communicate with HCPs about these uses.  You have a responsibility to understand and comply with these requirements.

Adherence to Product Labeling – Sales and Marketing Practices

Educational and promotional discussions, communications, and scientifically relevant materials pertaining to Okami’s approved products (as well as unapproved uses of our products), are consistent with the FDA’s guidance and recommendations.

Educational and promotional materials are reviewed and approved prior to external discussions, or distribution. Sales Representatives and other commercial field-based staff undergo training on appropriate practices to ensure any information provided is current, objective, scientifically sound, free from promotional influence and describes the limitations of the device.

HCP Product Training 

Okami Medical has a responsibility to demonstrate the safe and effective use of our products to HCPs. Training is consistent with approved product labeling.  Training venues may include independent teaching facilities such as a hospital or other appropriate clinical settings.

HCPs who have been invited by Okami Medical to attend training sessions may be reimbursed for reasonable travel and modest lodging and meal costs but may not receive other compensation for time spent in training.

Healthcare Professionals

The term Healthcare Professionals (“HCPs”), as used in the Code, encompasses the individuals, institutions, and other entities that prescribe, recommend, purchase, or influence the recommendation or purchase of our products or services.  We conduct our business with honesty and integrity and obey the laws and regulations in conducting our business with HCPs.

Our relationships with HCPs are very important to us and we are firmly committed to complying with the laws and regulations governing our interactions with them.

An interaction with an HCP can be anything from a brief product-related discussion between an employee and a physician – to entering into an agreement with an institution on the terms of a restricted educational grant.  All interactions with HCPs – no matter how brief or informal – must be conducted in accordance with existing laws, industry standards, the Program, and the Code.  The Code defines our commitment as a company – and as individuals – to abide by the laws, industry guidelines (i.e., AdvaMed Code of Ethics), country and region-specific guidelines, and Okami Medical’s policies and procedures that apply to day-to-day interactions with HCPs.

Under no circumstances may an employee engage in any conduct that unlawfully induces (or appears to unlawfully induce) an HCP to purchase, lease, recommend, use, or arrange for the purchase, lease, or use of an Okami Medical product.

Business Interactions with Healthcare Professionals (“HCPs”)

We interact with HCPs in compliance with laws, regulations, applicable industry standards and guidelines.  We keep medical decision-making free of improper industry influence – as an employee, you are prohibited from offering or giving anything of value to an HCP in order to induce or influence that person to prescribe, use, purchase, lease or recommend our product.

Patients undergoing medical treatment share the expectation that decisions made on their behalf are guided by objective medical knowledge and are free of improper influence.  A growing number of laws, guidelines and medical device compliance policies have been introduced to help preserve the independence of medical decision-making.  They regulate giving or offering anything of value to HCPs to avoid improperly influencing choices made in the best interests of patient care.  Industry guidelines (i.e., AdvaMed Code of Ethics on Interactions with HCPs) and our compliance policies also are intended to limit even the appearance of improper influence.

Employees are responsible for knowing Okami’s policies and procedures regarding our activities and interactions with HCPs, including offering and/or providing modest and occasional travel and meals, as well as engaging an HCP for consulting purposes.  You are expected to refer to them and/or reach out to your manager or the company’s designated Compliance Specialist when you are considering (1) use of an HCP as a consultant, (2) sponsoring medical seminars or educational conferences attended in person or virtually by HCPs, (3) requests for restricted educational, research, or fellowship grants, (4) scheduling and hosting speaker programs and paying speaker fees and (5) sponsoring trips for HCPs to medical and/or other business meetings.

Modest and Occasional Business Meals and Travel with HCPs

Okami Medical is expected to adhere to industry standards and the Program for conducting business and providing meals and travel to HCPs and their staff. To avoid even the appearance of improper influence, business meetings with HCPs and their staff are limited to settings conducive to the exchange of information related to our business and products. Okami Medical may offer modest and occasional meals as part of a business discussion about scientific or clinical information related to our products.

Written Arrangements with Healthcare Professionals

Okami Medical is permitted to enter into agreements with HCPs who provide services that are of bona fide value to the company (e.g., consulting, training and education, clinical research, advisory board participation, product development, and speaking engagements).

Services must relate to an area of legitimate, pre-approved business interest to Okami Medical identified on a Business Justification Form.

Compensation is consistent with the fair market value (FMV) methodology and analysis.

The agreement is clearly documented in a signed contract outlining HCP’s responsibilities, the duration of the arrangement, and the terms of the FMV compensation.

HCP speakers can present scientific, educational and non-promotional information pertaining to our products and services and may receive payments consistent with FMV reflected in their consulting agreement.

HCPs may also be reimbursed for modest and occasional meals and reasonable travel and lodging expenses incurred in the fulfillment of their agreements.

Okami is expected to adhere to industry standards and the company’s policies regarding providing hospitality, meals, and educational items to HCPs – whether they are under an agreement with Okami or not – to include, among other things, (1) sales calls and business meetings are limited to settings conducive to exchange of scientific, clinical and educational information, (2) occasional and modest meals may be offered to HCPs as part of business discussions, (3) recreational or entertainment events with HCPs are prohibited, (4) attendance at events by spouse, children or guests of HCP is not permitted and (5) Okami may offer reasonable, necessary, and pre-approved travel and lodging.

Relevant employees will be trained on interactions with HCPs and therefore are responsible for knowing our compliance policies and procedures regarding activities and interactions with HCPs. Refer to the policies and contact the designated Compliance Specialist when you are considering any HCP interaction, including but not limited to:

• Use of an HCP as a consultant
• Sponsoring medical seminars and/or providing restricted educational grants
• Paying an HCP for a one-time service, i.e., speaker at event
• Scheduling a business meal with an HCP

We have adopted the AdvaMed Code of Ethics for Interactions with HCPs to guide our interactions with HCPs, as well as follow similar industry standards and best practices.  Keep in mind, hospitals and clinics may have their own policies regarding their HCPs working with industry, and we also are mindful of other local and national laws may govern HCP relationships.  Okami Medical may work with external healthcare attorneys and other subject matter experts regarding any issues that may arise in various jurisdictions regarding interactions with HCPs.

Anti-Bribery and Anti-Corruption

We do not bribe.  We do not make or receive improper payments, nor do we entertain or offer inappropriate gifts to our HCPs or anyone in a position to purchase or influence the decision to purchase or recommend our products.  We do not participate in illegal or unethical behavior or any corrupt practices, nor do we allow those who work on our behalf to make or offer them.  We keep accurate and transparent books and business records.

All employees and consultants, vendors or other individuals representing Okami Medical must follow the laws of the country in which they operate as well as the U.S. Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act.  These laws are serious and far-reaching, and companies that violate them risk not only damage to their reputation and future success, but also costly lawsuits, substantial fines, and even jail/prison times for individuals.  Remember individual accountability in all interactions.

We are committed to securing business based solely on the quality of our products.  Regardless of local or custom competitive practices, we do not offer, make or authorize, request, agree to receive or receive payment of money or anything of value – including cash, gifts, travel expenses, entertainment, charitable or political contributions, payments, sponsorships, loans or employment offers to influence the judgement or conduct, or to ensure a desired outcome or action of any individual or entity.

WAIVERS AND AMENDMENTS

We will waive application of the policies set forth in the Code only where circumstances warrant granting a waiver.  Waivers for directors and executive officers may be made only by the Board of Directors or a designated committee and must be promptly disclosed as required by law or regulation.