Reporting and Responding to Compliance Issues Policy

1. Policy

1.1. This Policy on Reporting and Responding to Compliance Issues (this “Policy”) applies to all Personnel of Otsuka ICU Medical LLC and its (“Otsuka” or the “Company”) and sets forth the duties and responsibilities of Otsuka Personnel to report and raise Compliance Issues. This Policy also articulates Otsuka’s commitment to prohibit retaliation against or intimidation of any Otsuka Personnel who reports or raises, in good faith, a Compliance Issue or who provides information for an investigation or investigates such matter. This Policy also describes Otsuka’s process for responding to a report of a potential Violation, including processes for tracking, investigating, and taking disciplinary actions, corrective actions and other remedial actions for each matter, as appropriate.

2. Definitions

2.1. For purposes of this Policy, the following terms have the following meanings:

2.1.1. “Compliance Issue” includes any question, concern or issue related to Otsuka’s Code of Conduct and Business Ethics (the “Code”), Otsuka’s policies and procedures, Otsuka’s financial accounting, internal controls and auditing practices, and applicable laws, regulations and industry guidelines.

2.1.2. “Disclosure Program” means Otsuka’s program enabling and encouraging Otsuka Personnel to report and raise Compliance Issues and disclose any potential Violations, including through Otsuka’s Anonymous Reporting Hotline.

2.1.3. “Otsuka Personnel” includes Otsuka officers, directors and full-time, part-time, temporary, and contract employees of Otsuka.

2.1.4. “Violation” means an act or omission that violates the Code, Otsuka’s policies and procedures, Otsuka’s financial accounting, internal controls and auditing practices, and applicable laws, regulations and industry guidelines, including any act or omission that may put Otsuka at risk for regulatory or compliance scrutiny, or legal action.

3. Scope

3.1. This Policy is applicable to all Otsuka Personnel. In addition, Otsuka strongly encourages third parties, including vendors and contractors of Otsuka, to report and raise Compliance Issues.

4. General Requirements

4.1. Reporting Responsibilities

4.1.1. Otsuka Personnel are responsible for promptly reporting and raising any Compliance Issues.

4.2. Culture of Compliance

4.2.1. All Otsuka Personnel who have supervisory or management responsibilities and/or are members of the Human Resources department, Finance department, and the Company’s Board of Directors are expected to foster a culture of compliance and ethics; create a culture that enables Otsuka Personnel to comfortably report and raise any Compliance Issues; and keep an “open-door” policy to encourage Otsuka Personnel to report and raise any Compliance Issues.

4.3. Prohibition Against Retaliation

4.3.1. Otsuka does not permit retaliation against or intimidation of any Otsuka Personnel who has reported or raised, in good faith, any Compliance Issues or any Otsuka Personnel who provides information in an investigation or investigates any potential Violation.

4.4. Oversight by the Audit and Compliance Committee

4.4.1. Otsuka’s Board of Directors is responsible for oversight and governance of compliance-related matters, including oversight over ICU Medical’s Disclosure Program and ensuring prompt and appropriate responses to potential Violations.

5. Procedures

5.1. Reporting Process

5.1.1. Otsuka Personnel may report or raise any Compliance Issues:

5.1.1.1. By calling ICU Medical’s anonymous and confidential toll-free reporting hotline (“ICU Medical’s Anonymous Reporting Hotline”) at 1-844-330-0007;

5.1.1.2. By email to reports@lighthouse-services.com (must include Company’s name in the report);

5.1.1.3. By web submission at https://www.lighthouse-services.com/icumed;

5.1.1.4. By contacting a direct supervisor, a direct supervisor’s manager, a member of the Company’s Human Resources department, or ICU Medical’s Compliance Officer; and

5.1.1.5. ICU Medical Personnel located in EU shall be subject to local applicable laws and their use of ICU Medical’s Anonymous Reporting Hotline should be in accordance with any related privacy notices that may be provided by ICU Medical, Lighthouse-Services or otherwise.

5.1.2. Otsuka discourages the use of social media for reporting or raising any Compliance Issues.

5.1.3. Otsuka shall publicize the existence of the Disclosure Program, including ICU Medical’s Anonymous Reporting Hotline, via periodic e-mails to Otsuka Personnel, posting information on Otsuka’s infonet, posting information in facility common areas, through references in the Code, during compliance training and other means, as appropriate.

5.1.4. All Otsuka Personnel who receive a report of a Compliance Issue, whether verbally or in writing, are required to communicate such report to the Company Human Resources Department.

5.1.5. To the extent allowed by law and as appropriate, Otsuka and/or ICU Medical’s Compliance Officer, as applicable, shall protect the identity of individuals who request anonymity when reporting a Compliance Issue.

5.2. Receipt of Reports

5.2.1. All reports of Compliance Issues through all reporting channels shall be reviewed by the applicable personnel.

5.2.2. Upon receipt of a report, such personnel shall review the report to determine whether further review or investigation should be conducted. Such personnel shall ensure that all substantiated reports of a potential Violation will be investigated.

5.2.3. If a report concerns a Compliance Issue involving an Otsuka officer or director, such personnel shall provide a summary of the report to the Otsuka Board of Directors. The Otsuka Board of Directors may engage outside experts to assist with review, investigation or other actions, as appropriate.

5.3. Investigation Process

5.3.1. Such personnel shall initiate and oversee.

5.3.1.1. Each matter shall be referred to the appropriate department within Otsuka to investigate or assist with investigations, as appropriate. For example:

(a) Reports involving employment/workplace issues shall be sent to the Company Human Resources department;

(b) Reports involving accounting/financial issues shall be sent to the Otsuka Finance and the Otsuka Internal Audit department; and

5.3.1.2. Outside experts, including accounting experts, can be brought in, as needed and appropriate.

5.3.1.3. Depending on the facts and circumstances, including nature and severity of the potential Violation, the Company shall consider using outside legal counsel to assist in conducting an internal investigation under attorney-client privilege.

5.3.2. The nature and scope of the investigation will vary according to the facts and circumstances, but each investigation should be sufficiently detailed to identify the root cause of the concern.

5.3.3. Investigations shall be treated in as confidential a manner as appropriate under the circumstances.

5.3.4. All Otsuka Personnel shall fully cooperate with all compliance investigations and keep the fact that the investigation is being conducted as well as anything discussed confidential.

5.4. Remedial Actions

5.4.1. Disciplinary Actions

5.4.1.1. If Otsuka and/or ICU Medical’s Compliance Officer, as applicable, determines that Otsuka Personnel has committed a Violation, in consultation with the Company Human Resources department, such personnel shall take all appropriate disciplinary action up to and including termination, such as coaching or training; oral or written warning; suspension; demotion; reduction in compensation; and termination.

5.4.1.2. The severity of the disciplinary action will depend on the facts and circumstances, including:

(a) The nature and severity of the Violation;

(b) The authority of the individual involved;

(d) Whether the individual self-reported the conduct; and

(e) Whether the individual cooperated with the investigation.

5.4.2. Corrective Actions

5.4.2.1. If such personnel, determines that there has been a Violation, Otsuka shall take all appropriate corrective actions to correct any deficiencies and prevent similar future Violations, including conducting compliance training, implementing formal corrective action plans and such other appropriate measures to improve or modify performance, processes, or policies and procedures.

5.4.2.2. Business, as appropriate, shall consult with such personnel to develop and implement appropriate corrective action plans.

5.4.3. Additional Remedial Actions

5.4.3.1. Otsuka may take such other remedial actions, as appropriate.

5.4.3.2. If such personnel, determines that there has been a Violation of law, Otsuka shall take remedial actions, including reporting to the governmental and regulatory authorities, as appropriate.

5.5. Prohibition on Retaliation

5.5.1. Otsuka Personnel may not be discharged, demoted, suspended, threatened, harassed or discriminated against for reporting and raising, in good faith, any Compliance Issues, or for providing information in an investigation or assisting in investigating a potential Violation.

5.5.2. Any Otsuka Personnel who believes retaliation or intimidation is occurring or has occurred must report the concern promptly.

5.5.3. Any Otsuka Personnel who engages in retaliation or intimidation in violation of this Policy shall be subject to disciplinary action, as appropriate.

5.6. Reporting to the Company Board of Directors

5.6.1. On a quarterly basis, the Company shall provide a summary report of Compliance Issues, including numbers and types of Compliance Issues reported through all reporting channels, numbers of non-substantiated and numbers of investigated matters, status of investigations, and disciplinary, corrective and other remedial actions taken, to the Company Board of Directors.

5.7. Recordkeeping

5.7.1. The Company shall maintain documentation regarding all reported Compliance Issues, including the following:

5.7.1.1. Log of all reports of Compliance Issues through all reporting channels, including status and disciplinary, corrective or other remedial actions;

5.7.1.2. Scope, findings, and recommendations of investigations;

5.7.1.3. Any work papers, interview notes and other documents generated as part of an investigation; and

5.7.1.4. Any records that are attorney-client privileged, in secure fashion.

6. Documentation

6.1. Otsuka shall maintain all documentation required under this Policy in its records for a period of no less than four (4) years.

7. Auditing and Monitoring

7.1. This Policy, together with supporting documentation and records required by it, is subject to periodic auditing and monitoring.

8. Exceptions

8.1. Any exceptions to the requirements of this Policy must be approved by the Otsuka Executive Team.