Chapter 1　Purpose

This Global Policy on Publications (hereinafter referred to as the "Global Policy") aims to declare the fundamental principles for ONO Group to support compliance with Applicable Laws and Regulations and external publication standards when conducting Publications of Clinical Research results through scientific congresses or scientific journals.

Chapter 2　Definitions of Terminologies

Article1The terms used in this Global Policy are defined below.

1. "Applicable Laws and Regulations" means all laws, cabinet orders, ministerial ordinances, municipal ordinances, rules, guidelines, policies, notifications, and other public norms related to the business activities of ONO Group.
2. "Clinical Research" means any medical research involving human subjects, including clinical trials as well as non-interventional studies such as observational studies (both prospective and retrospective), post-marketing surveillance, chart review studies, questionnaire or survey research, real-world database studies, and health economics and outcomes research (HEOR).
3. "Creative Commons Attribution (CC BY) License" means the most open Creative Commons License, which permits the reproduction, distribution, modification, and reuse of copyrighted works for both commercial and non-commercial purposes, provided that proper attribution to the author is given.
4. "Creative Commons License" means an internationally standardized License Type that allows copyright holders to permit the reproduction, distribution, modification, and reuse of their works under predetermined conditions while retaining their copyright.
5. "Employee(s)" means directors, officers, regular employees, contract employees, and other employees of ONO Group, including temporary staff and fixed-term employees.
6. "Ghostwriting" means the act of substantially contributing to the content of Publications without disclosing such involvement and without being appropriately credited in the Publications.
7. "Global Policy(ies)" means a fundamental policy or policies commonly applied by the entire ONO Group which embody ONO Group's principles.
8. "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.
9. "HCPs" mean healthcare professionals, defined as any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of his or her professional activities may prescribe, recommend, purchase, supply, sell or administer a pharmaceutical product.
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. "License Type" means a contract or permission method that stipulates the terms and conditions for the use of copyrighted works granted to Publications.
12. "Manual(s) " means 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.
13. "ONO Group" means Ono Pharmaceutical Co., Ltd. and each of its Subsidiaries.
14. "Open Access" means a model of Publications in which research outputs such as academic articles are made freely accessible to anyone via the Internet and can be reused under appropriate conditions.
15. "Publications" means any form of external scientific disclosure of clinical research sponsored by ONO Group, including but not limited to abstracts, posters, and oral presentations at scientific congresses, as well as original articles, letters to the editor, case studies, and review articles in scientific journals. For the avoidance of doubt, Publications under this Global Policy do not include press releases, corporate websites, social media posts, slide-sharing platforms, promotional/advertising materials, or dissemination of results from investigator-sponsored research (ISR).
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.

Chapter 3　Scope

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

Chapter 4　Basic Principles

Article1General Statements

1. ONO Group is committed to unbiased Publications with scientific integrity, recognizing the importance of sharing clinical research results with researchers, HCPs, and the general public.
2. ONO Group is committed to Applicable Laws and Regulations and the credible, ethical, transparent, and timely development and disclosure of all Publications.
3. Additional requirements and standards shall be governed by and in compliance with Individual Entity Policies and Manuals of each ONO group company.
4. 4. When there is a conflict between this Global Policy and any applicable Individual Entity Policies, the stricter policy will apply.

Article2Compliance with Applicable Laws and Regulations and External Publication Standards

ONO Group adheres to all Applicable Laws and Regulations and external publication standards, including but not limited to:

1. The International Committee of Medical Journal Editors (ICMJE) Recommendations
2. Applicable industry codes for each country
3. The Committee on Publication Ethics (COPE)
4. Good Publication Practice (GPP) guidelines of the International Society for Medical Publication Professionals (ISMPP)
5. Good Practice for Conference Abstracts and Presentations (GPCAP)

Article3Fair Presentation of Clinical Research Results

All Publications of Clinical Research results sponsored by ONO Group must be presented in an unbiased, objective, balanced, and complete manner. Negative results cannot be suppressed, and favorable results cannot be unreasonably emphasized over unfavorable results. Publications must present trial design, strengths, and limitations, as well as the underlying scientific and medical data, analyses, and related information.

Article4Timing of Publications

ONO Group will diligently publish results of completed Clinical Research in a timely manner in compliance with Applicable Laws and Regulations. However, to protect intellectual property (IP) rights such as patents, all Publications must be reviewed by representatives of IP, and Publications may be delayed for a reasonable period.

Article5Authorship and Prohibition on Ghostwriting

1. In ONO Group, authorship credit is based only on the ICMJE criteria: Only those individuals who meet all ICMJE criteria will be named as authors.
2. Employees who meet the ICMJE criteria must be included as authors and disclose their affiliation with ONO Group.
3. ONO Group must not grant Authorship for the purpose of encouraging or rewarding the prescription, referral, or recommendation of ONO Group’s products.
4. ONO Group prohibits Ghostwriting by Employees or any other third party.

Article6Transparency and Disclosure

ONO Group requests authors to disclose any conflict of interest, including financial relationships, such as payments from ONO Group and other companies; and personal relationships that may present a conflict with respect to the Publication.

Article7Prohibitions on Compensation for Publications

ONO Group does not compensate for publication authorship. Reasonable and appropriate travel, accommodation, and registration expenses may be reimbursed for attending scientific meetings to present Publications.

Article8Independence from Promotional Intent

1. To ensure that the publication process remains independent of promotional intent, Employees who are part of marketing and commercial function must not manage, facilitate, or control the draft or approval of the content of Publications.
2. To ensure scientific balance and to avoid promotional tone or content, Employees who are part of the marketing and commercial function must not draft, revise, or approve the content of Publications. Employees who are part of the marketing and commercial function may participate in strategy or planning meetings of Publications, provide non-binding advice, and share insights on medical education gaps that may be addressed through peer-reviewed scientific publications. However, Employees who are part of the marketing and commercial function cannot manage, facilitate, or control the strategy or planning of Publications.
3. Market Access personnel may serve as authors or reviewers in HEOR, patient reported outcome studies, and real-world evidence studies.

Article9Submission to Peer-reviewed Journals, Open Access, and License Type

1. ONO Group recognizes the importance of external review and validation of its research results. To the extent possible, Publications should be presented at scientific congresses and/or submitted to peer-reviewed journals with an editorial board.
2. Whenever possible, ONO Group requests authors to select an Open Access model for journal publications, in order to maximize accessibility and transparency of the research results.
3. Whenever possible, ONO Group requests authors to select the Creative Commons Attribution (CC BY) license or the most permissive License Type available for journal publications, to facilitate broad dissemination and reuse of the research results.

Supplementary Provisions

This global policy was approved by the Management Committee on 24 July 2026 and shall take effect on 1 August 2026.

Established on 1 August 2026