Chapter1　Purpose

The purpose of this Global Policy is to define a framework for compliance management, and promote compliance across the ONO Group.

Chapter2　Definition of Terminologies

Article1The terms used in this Global Policy are defined below.

1. “All Policies” mean Global Policies and other Policies (including rules, detailed rules, and other items equivalent to Individual Entity Policies).
2. “Applicable Laws and Regulations” mean all laws, cabinet orders, ministerial ordinances, municipal ordinances, rules, guidelines, policies, notifications, and other public norms related to the business activities of the ONO Group.
3. “Compliance Program” means the organizational structure and framework that enable the ONO Group to operate an effective PDCA cycle for promoting compliance which consists of the establishment of compliance-related policies and measures (Plan), implementation (Do), verification and evaluation of effectiveness (Check), and improvement (Act).
4. “Compliance Supervisory Function” means an organizational unit established within each Ono Group entity that is independent from business‑promoting functions and is responsible for centrally managing all activities related to corporate compliance. Depending on the organizational structure, this role may also be assigned to an individual. Each ONO Group entity may delegate the establishment of its Compliance Supervisory Function to another group entity.
5. “Department” means a department, office, section, or an equivalent organizational unit.
6. “Division” means a Headquarters or any equivalent organizational unit.
7. “Employees” mean directors, officers, regular employees, contract employees, and other employees of the ONO Group, including temporary staff and fixed-term employees.
8. “Global Policy(ies)” mean a fundamental policy or policies formulated by OPHQ which embody ONO Group's principles.
9. “GxP-SOPs” mean written procedures established by each entity to standardize each process of research, development, manufacturing, marketing, distribution and others for pharmaceutical products in accordance with the standards, including, but not limited to GCP, GMP, GVP, required by the laws, regulations, and ministerial ordinances applicable to the pharmaceutical business in each country. GxP-SOPs are managed by each relevant function.
10. “Individual Entity Policy” means basic regulatory requirements, authorities, responsibilities, procedures, and methods of operation, consistent with the principles of the Global Policy, that are established and applied by each entity.
11. “Manual(s)” mean a procedural document or documents other than GxP-SOPs, which describe specific procedures, activities, and implementation guidelines for departments and entities involved in relevant operations when Employees perform their duties.
12. “ONO Group” means Ono Pharmaceutical Co., Ltd. and each of its Subsidiaries.
13. “OPHQ” means a global headquarters function of Ono Pharmaceutical Co., Ltd.
14. “Prior Consultation” means seeking advice and discussion with the OPHQ Compliance Supervisory Function, prior to implementation, regarding matters specified in the Exhibit.
15. “Reporting” means submitting a report to the OPHQ Compliance Supervisory Function, regarding matters specified in the Exhibit.
16. “Subsidiary(ies)” means an entity or entities in which Ono Pharmaceutical Co., Ltd. directly or indirectly holds a majority of voting rights (more than 50%) or otherwise exercises equivalent substantial control. Indirect ownership includes all entities in a continuous chain of control, such as subsidiaries and sub-subsidiaries.

Chapter3　Scope

This Global Policy applies to each ONO Group entity and their Employees. In the event of any discrepancy between this Global Policy and Individual Entity Policy or Manual, the more restrictive provision shall prevail.

Chapter4　Basic Principle

Article1Compliance Management Basic Guideline

ONO Group is committed not only to compliance with Applicable Laws and Regulations, but also to conducting its corporate activities based on the highest ethical standards.
As a fundamental guiding principle to achieve this commitment, the ONO Group hereby establishes the “Compliance Management Basic Guideline,” as set forth in Appendix 1.

Article2Compliance-based Management

ONO Group positions compliance as a pillar of its corporate management and ensures that its Employees approach their work with a strong awareness to prevent any compliance violations.

Article3Organizational Structure and Framework of Compliance Program

1. ONO Group shall establish the organizational structure※1 and framework※2 of the Compliance Program as set forth in Paragraphs 2 through 13 of this Article. Matters stipulated in Paragraphs 2 through 13 may also be addressed jointly with other group entities.
   ※1 Organizational structure:
   Board of Directors, Management Meeting, Sustainability Strategic Meeting, Corporate Officer in charge of Compliance, Group Compliance Committee, Compliance Supervisory Function, Audit & Supervisory Board
   ※2 Framework:
   Establishment of All Policies, Training and Awareness‑Raising, Whistleblowing System, Third Party Due Diligence, Compliance Risk Assessment, Audit by Internal Audit Department
2. Board of Directors
   OPHQ Board of Directors shall make decisions on important matters pertaining to the establishment of the organizational structure or framework of the ONO Group Compliance Program. OPHQ Board of Directors shall receive reports from the Corporate Officer in charge of Compliance and take necessary actions based on such reports.
3. Management Meeting
   OPHQ Management Meeting shall deliberate the appropriateness of the contents of the matters described in the foregoing Paragraph that are subject to the resolution of the Board of Directors before they are presented to the Board of Directors.
4. Sustainability Strategic Meeting
   The OPHQ Sustainability Strategy Committee shall, as necessary, deliberate on the appropriateness of matters to be submitted to the Board of Directors and the Management Meeting regarding the ONO Group’s Compliance Program prior to such submission.
5. Corporate Officer in Charge of Compliance
   In order to promote compliance in the ONO Group, a Corporate Officer in charge of Compliance shall be appointed at OPHQ. The Corporate Officer in charge of Compliance shall oversee the proper establishment and operation of the ONO Group’s Compliance Program, make determinations on specific matters related to the operation of the Compliance Program, and operate the Group Compliance Committee.
6. Group Compliance Committee
   The Group Compliance Committee shall be established at OPHQ and shall be responsible for the proper operation of the Compliance Program. The Group Compliance Committee shall deliberate on and make decisions regarding matters to be submitted to the Board of Directors, Management Meeting, Sustainability Strategic Meeting, or Board of Auditors related to the Compliance Program, as well as the establishment of All Policies and other matters reported or shared by Subsidiaries.
7. Compliance Supervisory Function
   Each ONO Group entity shall establish a Compliance Supervisory Function. The OPHQ Compliance Supervisory Function, under the supervision of the Corporate Officer in Charge of Compliance, shall oversee ONO Group‑wide activities related to the establishment and operation of the Compliance Program.
8. Audit & Supervisory Board
   OPHQ Audit & Supervisory Board shall audit the promotion of compliance within the ONO Group and provide necessary guidance for improvement to the OPHQ directors. OPHQ Audit & Supervisory Board shall also receive regular reports from the Group Compliance Committee.
9. Establishment of All Policies
   Each ONO Group entity shall, based on the Compliance Management Basic Guidelines, establish and maintain the necessary All Policies.
10. Training and Awareness‑Raising
    Each ONO Group entity shall formulate an annual plan for compliance training and awareness‑raising activities for its Employees.
11. Whistleblowing System
    Each ONO Group entity shall establish and operate a whistleblowing system to identify and capture concerns regarding compliance raised by Employees and to enable them to report or consult directly with the Compliance Supervisory Function regarding compliance issues.
12. Third Party Due Diligence
    Each ONO Group entity shall conduct risk-based third‑party due diligence, with a focus on verifying the counterparty’s compliance framework and any past compliance violations, at the start of a business relationship and, as necessary, during the course of the relationship.
13. Compliance Risk Assessment
    Each ONO Group entity shall conduct assessments to identify and evaluate its own compliance risks, assess whether any compliance concerns or issues exist, and consider and implement necessary enhancement or corrective measures as appropriate.
14. Audit by Internal Audit Department
    ONO Group shall ensure that the establishment and operation of the Compliance Program at each ONO Group entity is subject to audits conducted by the OPHQ Internal Audit Department.

Article4Response to Violation and Thorough Prevention of Recurrence

1. Each Ono Group entity shall, if any compliance violation is found, thoroughly investigate the facts and root causes in cooperation with the relevant Department as necessary. Based on the investigated facts, each Ono Group entity shall require the relevant Department to take the necessary actions on behalf of the company, including but not limited to prompt remediation of the violation, disciplinary action for the responsible parties, and measures to prevent recurrence.
2. Each Ono Group entity shall monitor the progress of recurrence prevention measures and verify their degree of implementation and effectiveness of implementations through relevant audits.
3. Notwithstanding the foregoing, Paragraph 1 and 2 of this Article may be implemented together with other group entities.

Article5Framework of Prior Consultation and Reporting

1. Each Ono Group entity shall, in accordance with the provisions set forth in the Exhibit conduct Prior Consultation with or submit Reporting to the OPHQ Compliance Supervisory Function. They shall also report to the reporting channels designated by each entity, as necessary.
2. The responsible person of the OPHQ Compliance Supervisory Function shall report to the Group Compliance Committee on any Prior Consultation or Reporting made pursuant to Paragraph 1 of this Article.
3. Subsidiaries are obliged to conduct Prior Consultation and Reporting even if such requirements are not stipulated in their Individual Entity Policies or Manuals, unless such actions violate Applicable Laws and Regulations. If such actions violate Applicable Laws and Regulations, such Subsidiaries shall discuss and agree on the necessary measures with the OPHQ Compliance Supervisory Function.
4. The OPHQ Compliance Supervisory Function, under the direction of the Corporate Officer in charge of Compliance, shall reach conclusions or determine response policies and communicate the results promptly regarding matters submitted through Prior Consultation by each ONO Group entity. The OPHQ Compliance Supervisory Function shall also provide guidance and advice on Reporting, as necessary.

Exhibit

Article6Compliance Requirements

1. Each ONO Group entity shall, in consultation with the OPHQ Responsible Department, establish its Individual Entity Policy or Manual as necessary, which is consistent with this Global Policy and is in compliance with Applicable Laws and Regulations.
2. Each ONO Group entity may, in consultation with the OPHQ Responsible Department, delegate the establishment of such Individual Entity Policy or Manual to another ONO Group entity or apply a common Individual Entity Policy or Manual together with other ONO Group entities.

Supplementary Provisions

1. This Global Policy was approved by the Management Meeting on February 21st,2023 and shall take effect on March 28, 2023.
2. When revising or abolishing this Global Policy, the proposal shall undergo deliberation and approval by the Board of Directors, followed by submission for Ringi approval.

Revision on July 1st, 2026

Appendix1　“Compliance Management Basic Guideline,”