Compliance

Santen has established the Santen Corporate Code of Practice as our code of conduct which is built on Santen's Core Principle of "Tenki ni sanyo suru". The Code of Conduct requires all corporate executives and employees including contract and temporary staff, to understand the spirit behind Santen's Core Principle and to act with high standards of ethics befitting employees at Santen. CEO, Chief Compliance Officer and other senior leaders continuously provide messages to all Santen employees on the importance of compliance with the "Santen Code of Practice". Tone at the top is key to building a culture of compliance and strict adherence to the code so that we truly earn our customers' trust. Santen has published translations of the Santen Code of Practice, a Code of Conduct, in 13 languages and is received and attested by every employee globally. Additionally, to ensure all employees fully understand the Code of Practice, Santen conducts a variety of awareness activities both locally and globally including new hire training on a regional basis as well as annually designating November as the Awareness Month for Santen's code of practice. This month is dedicated to promoting the Code of Practice to all employees through messages from senior leaders, a mandatory global annual training, and other various corporate informational activities.

Santen has implemented strict measures to deter non-compliance with the Code of Practice through the Speak-up program, incident investigation and corrective actions.

Santen engages with the healthcare industry directly and is connected to people's lives and health. Our business activities involve frequent interactions with government employees and healthcare professionals in all settings, including research and development, manufacturing, and sales. This requires us in the healthcare industry to ensure high transparency in our corporate activities. Given the nature of our unique position, it is essential that integrity and ethics is at the core of all our business activities and interactions.

With this understanding and commitment to integrity and transparency, as well as our determination to comply with applicable laws and regulations, Santen has established the "Santen Global Compliance Policy" based on the Code of Practice of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), of which many of the world's pharmaceutical companies are members.

The Policy is aimed at ensuring that all Santen Group corporate executives and employees comply with laws, regulations and industry codes, and act in a highly ethical and sincere manner, and contribute to a better Quality of Life (QOL) for all patients. The Policy is received by every employee globally through a sign and certify training at the time of new hire, with additional various detailed trainings on its content throughout the year.

The Company has appointed a Chief Compliance Officer and established a Compliance Committee consisting of executives in charge of each region and function. This committee promotes a variety of compliance measures both globally and regionally, including dissemination of the basic philosophy and regulations, fostering a corporate culture of compliance, and responding to compliance issues that may arise. The Company has also assigned a Compliance Head for each region under the Chief Compliance Officer to ensure all employees of their assigned region(s) adhere to Santen Code of Practice, Santen Global Compliance Policy, Standard Operating Procedures, local laws and rules. This is accomplished through regular trainings and compliance checks such as auditing and monitoring, local risk assessments, engagement approvals and other various compliance oversight of activities. Additionally, all compliance heads meet regularly to discuss methods for promoting decisions made by the Compliance Committee, measures for dealing with local and or global compliance issues, new laws and/or guidance, and general compliance information sharing.
 

The Santen Compliance Program is designed to cover all necessary elements to reduce compliance risk and prevent violations. Under Santen Code of Practice and Santen Global Compliance Policy, detailed guidelines and SOPs are established to articulate how to conduct business operations in a right way and compliance check mechanisms are embedded in day-to-day business operations. Also, the compliance department conducts risk assessments based on business plans at the beginning of the year, as well as planning and executing auditing and monitoring. Questionable conduct is investigated and disciplined in accordance with defined procedures, followed by corrective actions. Findings made though this proactive compliance cycle are reflected for the betterment of the compliance program by recognizing potential issues, aligning compliance activities to mitigate potential risk, and fostering an overall culture of compliance within the company.

All employees receive regular compliance trainings both at the time of new hire and throughout the year. All employees must sign and certify their receipt of, and commitment to, complying with the Santen Global Compliance Policy, Santen Code of Practice and all other applicable guidelines and SOPs. Additionally, Santen makes efforts to raise compliance awareness by designating November of each year as Awareness Month for Santen's code of practice. In this month, annually, the compliance department provides all employees with multiple activities such as a global compliance refresher training, strong collaboration with all senior leaders on dissemination of compliance messages and other various activities that promote companywide compliance understanding. Compliance training participation rate is incorporated into non-financial indicators of the employee evaluation and compensation system.

Additionally, Santen has established a global Speak-Up program in which all our employees and customers can anonymously report any potential violations via our Santen Speak-Up Portal online site or toll-free hotline number.

Santen also understands that adherence to our rules and regulations not only apply to our employees but also to the third-parties we contract with. In an effort to ensure our third-party acting on behalf of Santen adhere to Santen Code of Practice and Santen Global Compliance Policy and are free from sanctions and other potential restrictions, third-parties must be vetted through our third-party due diligence process and sign the agreement to comply with the requirements from Santen. All interactions are subject to the auditing and monitoring program to ensure appropriate interactions and payments made. Any violations found are subject to investigation, brought to the Compliance Committee Meetings and could result in corrective actions.

The Company has established an Anti-Bribery and Corruption Policy, reinforcing our global commitment to maintaining fair and high ethical standards in our interactions with government officials, healthcare professionals and the healthcare organization.

Santen prohibits corporate executives and employees from committing acts of bribery by clearly stating in Santen Code of Practice as a Code of Conduct that, "We do not engage in any conduct regarded as bribery or corruption, whether directly or through a third-party, that would violate the applicable laws and regulations of the relevant country, including those of any countries". All employees are trained on this subject annually and must sign and certify that they have received and understood that Santen Global Compliance Policy that lays out our position on ABAC. Furthermore, to mitigate the risk arising from Santen’s contracted third parties, Santen has established a process to conduct anti-bribery and anti-corruption due diligence on those third parties that will interact with government officials, healthcare professionals, and/or patient organizations on our behalf. Santen has also incorporated specific ABAC clauses into the contracts with such third parties.

Santen strictly prohibits the inappropriate use of grants, charitable donations, political contributions, purchasing, facilitation payments and all other forms of funding as a means of corruption in compliance with applicable laws, regulations and industry codes. These such transactions are subject to internal review and appropriate controls such as risk assessments, auditing and monitoring and our third-party due diligence program.

Santen also joined the United Nations Global Compact including its 10th Principle Anti- Corruption, and is committed to preventing corruption, including extortion, bribery, and embezzlement.

The amount of political contributions as well as industry and business association participation fees are disclosed in Governance Data. We do not do allow any lobbying activities.

To ensure a high standard on ethics and compliance, it is highly important to foster an environment that encourages employees to speak up when they feel there is a potential or actual violation to Santen Code of Practice, Santen Global Compliance Policy or other laws and regulations. With that in mind, Santen has set up an independent reporting hotline and web portal called, "Speak Up". This will allow an employee or a third-party, in good faith, to raise concerns online or by phone globally, 24/7, in multiple local languages with the capability to make a report anonymously where permissible by local laws and regulations.

All employees are made aware of the importance of "Speak Up" through communications from HR, Compliance, senior leaders, and other various channels using posters, e-banners, and online resources. Incoming consultations and reports are appropriately investigated and addressed in a sincere manner and are managed in this centralized system both globally and locally, and reports are relayed to the Board of Directors regularly.

In addition, Santen strictly prohibits retaliation against anyone who raises a concern or reports a suspected compliance violation in good faith even if the concern or report is not substantiated after investigation. Santen's compliance rules provide that the company must take appropriate measures to protect internal whistle-blowers in each area where it operates.

The contents of the consultation and reporting are harassment, conflict of interest, personnel/labor relations, financial integrity and others. Of the reports received, those deemed to require investigation are appropriately investigated. Of those cases, those that were found to be in violation of compliance were handled appropriately through disciplinary action.

The cases of consultation and reporting, and disciplinary actions are disclosed in Governance Data.

Santen established "Global Data Privacy Policy" in April 2020. Under this Policy, in order to properly handle and protect the personal information of patients, consumers and employees, Santen takes various measures including training of all corporate executives and employee and is striving globally to enhance our structure for privacy.

The presence or absence of breaches of client data reported to regulators is listed in Governance Data.