Chapter1　Purpose

The purpose of the Global Policy on Public Disclosure of Clinical Study Data (hereinafter referred to as the “Global Policy ”) is to share the ONO Group's clinical study data and their results with researchers, healthcare professionals, patients, etc.

Chapter2　Definitions of Terminologies

Article1The terms used in this Global Policy are defined below.

1. "Employee(s)" means directors, officers, regular employees, contract employees, and other employees of the ONO Group, including temporary staff and fixed-term employee.
2. "Global Policy(ies)" means a fundamental policy or policies commonly applied by the entire ONO Group which embody ONO Group's principles.
3. "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.
4. "ONO Group" means Ono Pharmaceutical Co., Ltd. and each of Subsidiaries.
5. "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 entity of ONO Group and Employees.

Chapter4　Basic Principle

Article1Sharing of Clinical Study Data

ONO Group believes that sharing clinical study data and results with researchers, healthcare professionals (HCPs), and patients contributes to the promotion of scientific studies and medical research, thereby leading to public benefits. ONO Group shares clinical study data in accordance with the guidelines stipulated in the “IFPMA Principles for Responsible Clinical Trial Data Sharing” presented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) dated January 15, 2018, as well as in compliance with industry guidelines, applicable laws, and regulation.

Article2Sharing Clinical Study Data with Researchers

Upon request of researchers, ONO Group may share data from our sponsored clinical studies in patients, which are included in the new drug application (NDA) documents for our products that have been approved for marketing or additional indications by the US Food and Drug Administration and the European Medicines Agency since January 1, 2014. However, ONO Group does not share clinical study data that does not meet our criteria for sharing clinical study data such as the following: clinical study data that are prohibited from being shared with a third party on the basis of legal issues, agreements with co-development companies, or the consent received from patients; clinical study data with risk of compromise to ONO Group’s commercial position (e.g., interfering with confidential information or intellectual property rights). The clinical study data to be shared is processed so that an individual person cannot be identified directly.
Before the clinical study data is shared, researchers will be reviewed by the review committee composed of third-party specialists. ONO Group provides researchers who pass this review with the network environment that enables them to share the clinical study data.

Article3Disclosure of Clinical Study Protocols and Results

ONO Group discloses protocols for our sponsored clinical studies in patients in clinical study databases that are available to the public. For any of our products that have been approved for marketing or additional indications in Japan or outside Japan since January 1, 2014, ONO Group registers and discloses summaries of the clinical study results that ONO Group has utilized for our NDAs in the clinical study databases. ONO Group also discloses the clinical study protocols and results in accordance with the provisions of applicable laws or regulations, if any, in the respective country.
However, ONO Group does not guarantee the accuracy and up-to-date nature of the information posted in the clinical study database managed by any third party other than the ONO Group. Therefore, ONO Group does not accept any legal responsibility for any issues arising from the use of information obtained from such clinical study databases.

Article4Publication of Clinical Study Results

ONO Group complies with the IFPMA Principles for Responsible Clinical Trial Data Sharing and related guidelines, and proactively strives to present and publish the results from all our sponsored phase 3 clinical trials and any clinical trials of significant medical importance (including those for discontinued investigational drugs) at academic conferences and in peer-reviewed scientific journals in a timely manner regardless of whether the results are positive or negative. However, to protect intellectual property rights such as patents, the publication may be delayed for a reasonable period of time.

Article5Handling of Personal Information

Regarding personal information that is related to the disclosure of clinical study information, ONO Group obtains personal information in compliance with all applicable laws and regulations. ONO Group collects personal information for a legitimate purpose in accordance with all applicable laws and regulations and limits its use of that personal information to the specified purpose. Furthermore, ONO Group takes and maintains risk management, security and organizational measures that are compliant with all applicable laws and regulations. ONO Group provides legal and appropriate responses to all data subjects and third parties in accordance with applicable laws and regulations. For further direction on our handling of personal information, please follow the Privacy Notice published on the official corporate website.

Supplementary Provisions

This Global Policy was approved and enforced on October 1, 2020.

Revision on July 1st, 2026