Chapter 1　Purpose

The purpose of this Global Policy is to appropriately manage various Risk from the perspective of overall optimization to ensure the stable continuation of ONO Group’s business operations. To this end, the ONO Group establish an Enterprise Risk Management (ERM) framework and fulfill its accountability to society regarding Risk Management.

Through these efforts, the ONO Group minimizes losses to the Group and to its stakeholders, including patients, and contributes to strengthening the competitiveness of the ONO Group.

Chapter 2　Definition of Terminologies

Article 1　The terms used in this Global Policy are defined below.

1. “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.
2. “Employee(s)” mean directors, officers, regular employees, contract employees, and other employees of the ONO Group, including temporary staff and fixed-term employees.
3. “ERM” means Enterprise Risk Management, defined as a company-wide framework and process for managing Risk from the perspective of overall optimization to achieve management goals and objectives.
4. “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.
5. “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.
6. “ONO Group” means Ono Pharmaceutical Co., Ltd. and each of Subsidiaries.
7. “OPHQ” means a global headquarters function of Ono Pharmaceutical Co., Ltd.
8. “Risk” means any event or condition that may cause physical, economic, or reputational loss or disadvantage to the ONO Group.
9. “Risk Management” means a series of measures and actions, including avoidance, mitigation, transfer, and other responses taken to minimize losses when Risk materialize and to obtain the best outcomes with minimal cost. This also includes the response actions taken when a Risk actually occurs.
10. "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.

Chapter 3　Scope

This Global Policy applies to each entity of ONO Group and Employees.

Chapter 4　Basic Principle

Article 1　General Principles

1. ONO Group shall promote ERM, whereby Risk is systematically and continuously identified, assessed, and addressed across all business activities under the responsibility of each entity president.
2. ONO Group shall comply with Applicable Laws and Regulations and Individual Entity Policy, and ensure ethical and transparent conduct, and establish the necessary environment to support such conduct.
3. The ONO Group shall make decisions based on Risk considerations and fulfill accountability for the rationale and outcomes of such decisions.
4. The ONO Group shall strive to prevent Risk before it occurs, and if a Risk materializes, shall take measures to minimize the impact, ensure swift recovery, and achieve prompt resolution.
5. The ONO Group shall provide continuous education and training on Risk Management to improve awareness and capabilities.
6. 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 the Applicable Laws and Regulations.
7. Each ONO Group entity may delegate the establishment of such Individual Entity Policy or Manual to another entity, or may apply a common Individual Entity Policy or Manual together with other entities.

Supplementary Provisions

This Global Policy was approved by the Management Committee on April 24, 2019, and shall take effect on May 1, 2019.

Revision on May 1st, 2026