Whistleblowing Global Policy

See here for the Whistleblowing Global Policy.

Chapter 1 Purpose

The purpose of this Global Policy is to establish a Whistleblowing System for ONO Group and to prevent, detect and correct the Misconduct at an early stage, based on the Compliance Global Policy.

Chapter 2 Definitions of Terminologies

Article1The terms used in this Global Policy are as 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. “Employees” mean directors, officers, regular employees, contract employees, and other employees of the ONO Group, including temporary staff and fixed-term employees.
  4. "Global Policy(ies)" means a fundamental policy or policies commonly applied by the entire ONO Group which embody ONO Group's principles.
  5. "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.
  6. “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.
  7. “Investigation Collaborator” means a person who cooperates in interviews and inquiries conducted by the ONO Group's Whistleblowing Response Personnel for the purpose of investigation.
  8. “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.
  9. “Misconduct” means the act set forth in 15(1) and (2) of this Chapter.
  10. “ONO Group” means Ono Pharmaceutical Co., Ltd. and each of Subsidiaries.
  11. “OPHQ” means a global headquarters function of Ono Pharmaceutical Co., Ltd.
  12. “Outside Parties” mean former Employees of each ONO Group entity and external business partners who have business relations with an ONO Group entity.
  13. “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.
  14. “Whistleblower” means a person who has made a Whistleblowing in accordance with this Global Policy.
  15. “Whistleblowing” means reporting or consultation with the Whistleblowing channel as set forth in Article 2 of Chapter 4 regarding any act that falls under, or is suspected of falling under, any of the following: Acts that violate Applicable Laws and Regulations on any entity within the ONO Group. Acts that violate the articles of incorporation, work rules, the ONO Group Code of Conduct, All Policies, GxP-SOPs, and Manual, including but not limited to the foregoing.
  16. “Whistleblowing Response Personnel” means a person who is involved in the Whistleblowing channel and internal Whistleblowing response operations.
  17. “Whistleblowing System” means ONO Group's whistleblowing system.

Chapter 3 Scope

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

Chapter 4 Basic Principle

Article1Responsibility

Employees shall endeavor to address any Misconduct they are aware of and shall actively utilize the Whistleblowing System of each entity as needed.

Article2Whistleblowing Channel

  1. Each ONO Group entity shall establish a Whistleblowing channel for Employees based on Applicable Laws and Regulations and make it known to Employees and operate an internal Whistleblowing channel responsibly. In addition, based on Applicable Laws and Regulations, each ONO Group entity may establish a Whistleblowing channel for Outside Parties as necessary.
  2. Each ONO Group entity may delegate the preparation, maintenance and operation described in the preceding paragraph to another entity.

Article3Prohibition of Reporting for Unauthorized Purposes

The Whistleblowers shall not report for the purpose of personal gain or other improper purpose or deliberately make false or slanderous accusations.

Article4Obligation of Cooperation

Employees shall cooperate in the investigation of Whistleblowing when requested. In addition, in the event that the provision of materials, including emails, documents, or data, is requested in connection with an investigation, relevant Employees shall cooperate to the extent permitted under the Applicable Laws and Regulations. Each ONO Group entity shall strictly comply with Applicable Laws and Regulations and, as permissible, impose disciplinary measures, including sanctions, on any individual who violates this Article.

Article5Corrective Measures and Preventive Measures

Each ONO Group entity shall, upon confirmation of Misconduct through investigation, promptly take corrective measures and preventive measures to the extent deemed necessary or appropriate.

Article6Disposition against Misconduct

  1. Each ONO Group entity shall, upon confirmation of Misconduct through investigation, as permissible, impose disciplinary measures, including sanctions, on the individuals involved, to the extent permitted under Applicable Laws and Regulations.
  2. Each ONO Group entity may, taking Applicable Laws and Regulations into consideration, review the possibility of mitigating disciplinary measures when Employees voluntarily engage in Whistleblowing regarding their own Misconduct or cooperate in investigations related to such Misconduct.

Article7Protection of Whistleblower

  1. Each ONO Group entity shall not dismiss, refuse to renew an employment contract, demote, reduce salary, or otherwise treat Whistleblowers and Investigation Collaborators (who act in good faith) disadvantageously, or retaliate against them on the grounds that Whistleblowers have reported or Investigation Collaborators have cooperated in the investigation.
  2. Each ONO Group entity must take appropriate measures to avoid a deterioration in the working conditions of Whistleblowers or Investigation Collaborators (who act in good faith) because Whistleblowers have reported, or Investigation Collaborators have cooperated with the investigation. In addition, appropriate remedies and recovery measures shall be taken against Whistleblowers or Investigation Collaborators who have received disadvantageous treatment in violation of the preceding paragraph.
  3. Each ONO Group entity shall strictly comply with Applicable Laws and Regulations and, as permissible, impose disciplinary measures, including sanctions, on any individual who engages in adverse treatment against Whistleblowers or Investigation Collaborators who acted in good faith.

Article8Confidentiality

Employees must not, without legitimate reason, leak or make any unauthorized disclosure of the contents of Whistleblowing or any information obtained through investigations to any third party. Each ONO Group entity shall strictly comply with Applicable Laws and Regulations and, as permissible, impose disciplinary measures, including sanctions, on any individual who violates this Article.

Article9Prohibition of Exploration

Employees must not, without legitimate reason, attempt to identify Whistleblowers or Investigation Collaborators in connection with Whistleblowing. Each ONO Group entity shall strictly comply with Applicable Laws and Regulations and, as permissible, impose disciplinary measures, including sanctions, on any individual who violates this Article.

Article10Education and Dissemination

Each ONO Group entity shall educate and inform Employees about the Whistleblowing System and respond to inquiries about the mechanism of the Whistleblowing System and its adverse handling received from Employees.

Article11Reporting to OPHQ Responsible Department

Each ONO Group entity shall report to OPHQ Responsible Department within the period specified in the Compliance Global Policy, to the extent permissible under Applicable Laws and Regulations in the event that the occurrence of the matters subject to reporting as stipulated in the Compliance Global Policy is confirmed by the Whistleblowing System.

Article12Compliance 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 in consistent with this Global Policy and is in compliance with the Applicable Laws and Regulations.
  2. 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.