Fair Operating Practices

To prevent corruption and corrupt practices and ensure fair competition, the Company promotes business activities in compliance with laws and regulations and high ethical standards together with its business partners.

Compliance

We have established a department to promote and support compliance within each Group company and developed the necessary internal systems, and rules and regulations. The structure we have created facilitates the prompt handling of cases, the formulation of measures to prevent violations, and other measures. This means that officers and employees can engage in corporate activities with peace of mind. To increase awareness of compliance of employees of the Group, we are conducting compliance education for each job level while working to grasp the level of employee awareness through questionnaire surveys and identify points for improvement. In FY2021, we conducted interviews with each department of the Group based on the results of the compliance awareness survey and worked for more thorough compliance by gaining a greater understanding of the current situation, identifying problems, and conducting training and problem solving based on actual conditions. The Group Compliance Promotion Committee has been established to supervise the Group’s efforts toward recognizing and responding to risks that could have a significant impact on Group management and promoting a compliance system that thoroughly complies with laws and corporate ethics.

Whistle-blower System

As a system to reflect the voices of employees in compliance practice, we have established a whistle-blower office, the ASKA Pharmaceutical Holdings’ compliance consulting desk, and have promoted awareness of the desk through education and training programs. In addition to the internal and external contact points that have been in place for some time, we have established a new contact point for consultation and reporting of compliancerelated matters involving officers of the Group. It is staffed by ASKA Pharmaceutical Holdings’ Audit & Supervisory Board members (Audit & Supervisory Board member consulting desk). This contact point, which is independent from senior management, is intended to lower the psychological hurdle forofficers and employees for consultation and reporting of compliance-related matters involving senior management, and to ensure that investigations and corrective measures are carried out in a timely and appropriate manner. Reporting can be also done anonymously, and all cases are handled appropriately. Through this system, we will ensure that whistle-blowers are protected and that compliance-related matters are reported, investigated, and corrective measures are taken in a timely and appropriate manner, in accordance with the spirit of the Whistleblower Protection Act.

ASKA Pharmaceutical Holdings Structure of the Compliance Consulting Desks

Anti-Bribery and Corruption Policy

ASKA Pharmaceutical Holdings Group (the "Group") is committed to preventing bribery and corruption in accordance with the Charter of Corporate Behavior and the Code of Conduct for Compliance.
This policy applies to all officers and employees of the Group. We request the same understanding from all domestic and overseas stakeholders, including those in our supply chain, who are involved in our business activities.

Prohibition of Bribery

In all of its business activities, whether in Japan or overseas, the Group shall engage in fair, transparent, and free competition, and shall maintain sound and normal relationships with medical professionals, related business partners, government agencies, political organizations (individuals), and others. We prohibit the giving or receiving of illegal money or other forms of payment.

Prohibition of Bribery by Business Partners, Agents, etc.

We request that all domestic and overseas stakeholders, including those in our supply chain, involved in our business activities understand the prohibition of bribery.

Anti-Bribery Due Diligence

The Group conducts due diligence on companies with which it intends to enter into new transactions or with which it already does business in order to mitigate risks related to bribery and corrupt practices.

Prohibition of Illegal Political Contributions

The Group prohibits illegal political contributions and other corrupt practices.

Risk Management

The Group Compliance Promotion Committee has been established to supervise the Group’s efforts toward recognizing and responding to risks that could have a significant impact on Group management and promoting a compliance system that thoroughly complies with laws and corporate ethics. A representative director or a senior member of the Board of Directors manages the committee as the Group Compliance Supervisor.

Whistle-blower System

As a system to reflect the voices of employees in compliance practice, we have established a whistle-blower office, the “ASKA Pharmaceutical Holdings’ compliance consulting desk,” and a new contact point for consultation and reporting of compliance-related matters involving its officers, “Audit & Supervisory Board member consulting desk.” It is staffed by ASKA Pharmaceutical Holdings’ Audit & Supervisory Board members.
Anonymous reporting is also accepted, and all cases are handled appropriately. In accordance with the spirit of the Whistleblower Protection Act, the Group protects whistleblowers and ensures that compliance-related matters are collected, investigated, and corrective measures are taken in a timely and appropriate manner.

Education and Training

To increase awareness of compliance of employees of the Group, we are conducting compliance education for each job level while working to grasp the level of employee awareness through questionnaire surveys and identify points for improvement.
We conduct interviews with each department of the Group based on the results of the compliance awareness survey and work for more thorough compliance by gaining a greater understanding of the current situation, identifying problems, and conducting training and problem solving based on actual conditions.

Role of Top Management and Enforcement of this Policy

The top executives and other officers shall take the initiative in taking action to prevent bribery and corruption in accordance with the Charter of Corporate Behavior and the Code of Conduct for Compliance, and shall ensure that all employees are fully aware of these standards.
In addition, we will understand internal and external opinions, build effective governance, and ensure that corporate ethics are thoroughly upheld. In the event of a violation of this policy, top management will take responsibility for resolving the problem, investigating the cause, preventing recurrence, and promptly and accurately disclosing information to the public. In addition, the top management will fulfill its responsibility as a corporation, restore trust in the Company, and take strict disciplinary action, including that of the Board of Directors and officers.

Supply Chain Policy

In order to realize its corporate philosophy, the Group shall engage in fair, transparent, and free competition in all its business activities in Japan and overseas, and shall maintain sound and healthy relationships with its business partners and other related parties.

Supply Chain Management

ASKA Pharmaceutical is taking the following measures for supply chain management both in Japan and overseas in order to ensure a stable supply of high quality pharmaceutical products.

1. Continuous supply chain re-inspection
   Leveraging existing internal systems, we are enhancing and updating supplier information. By centralizing and sharing this information, we are building a system that enables us always to do better business with our suppliers.
2. Supplier assessment and impact visibility
   Based on the aggregated information, we evaluate suppliers, visualize their impact, and clarify priorities as we work to improve issues.
3. Initiatives to maintain a stable supply
   To ensure a stable supply of products, we view it as important to strengthen our production system and improve productivity. ASKA Pharmaceutical manages the entire process from stable procurement of raw materials to commercialization of products, including checking the inventory status of APIs at manufacturing sites. We are also actively engaged in exchanging information with each supplier and collaborating with new suppliers to ensure the continuation of stable supply through planned and efficient production.

Intellectual Property

Intellectual property rights include patent rights, utility model rights, design rights, and trademark rights, which protect creations through intellectual creative activities. We respect the rights of third parties and cooperate with relevant departments to formalize and protect intellectual property rights throughout the Company. In addition to protecting rights related to newly developed products, we maximize value by utilizing intellectual property rights to extend the life cycle of existing products, including new dosage formulations.

Moreover, we are promoting the globalization of our intellectual property activities, and have established a system that enables us to collect and utilize intellectual property information overseas, and are working to strengthen cooperation with our partner companies in terms of intellectual property. With the growing importance of intellectual property, we will further contribute to our business growth through these efforts.

Code of Practice

As a responsible life-related company that handles pharmaceuticals, ASKA Pharmaceutical recognizes the need to ensure a high level of ethics and transparency in its corporate activities. Based on this recognition, in FY2013 we established the ASKA Pharmaceutical Code of Practice as a code of conduct for all officers and employees and their interactions with researchers, medical professionals, patient groups, etc., and we are implementing corporate activities that can be understood by society by ensuring that all officers and employees are fully aware of the code.

Initiatives of the Group in Industry-related Norms (Transparency Guidelines, Guidelines for Sales Information Provision Activities, etc.)

Transparency Policy for Corporate Activities

With the recognition that ASKA’s corporate activities related to prescription pharmaceuticals are conducted under the public medical insurance system, we are fulfilling our accountability to society by ensuring transparency in the provision of funds to medical professionals, medical institutions, patient groups, and others. In accordance with the Transparency Guideline for the Relationship between Corporate Activities and Medical Institutions and Transparency Guideline for the Relationship between Corporate Activities and Patient Groups, we will continue with FY2022 disclosure of information on FY2021’s provision of funds to medical professionals, medical institutions, and patient organizations.

Sales Information Provision Activities Policy

In addition, the Guidelines for Provision of Sales Information on Prescription Drugs (the “Guidelines”) were established by the Ministry of Health, Labour and Welfare to promote the proper use of prescription pharmaceuticals. They are aimed at preventing inappropriate promotional activities (such as recommending off-label use, slandering other companies, and providing misleading information on efficacy and safety). In addition, from 2019 the Guidelines made it the responsibility of management to establish the internal systems necessary for appropriate sales information provision activities and to educate employees.
The department supervising sales information provision activities, as the lead department, reviews materials used by medical representatives (MRs) to ensure that they are properly prepared, and also checks the promotional activities of MRs and others, and with regard to the behaviors that could have been taken as a violation of the Guidelines, the information is shared with the parties concerned as well as the relevant promotion department to raise awareness and prevent violations. In addition, we continuously remind MRs and others of the importance of compliance with the Guidelines and other industry-related norms during training sessions.
As a life-related company, we will continue to work to further improve our ethics, transparency, and credibility while conducting activities to deepen the understanding of medical institutions and medical professionals.

Basic Principles for Improving Access to Health Care and Access to Medicines

ASKA Pharmaceutical Holdings operates its business as a Specialty Pharma Company based on its corporate philosophy “Contribute toward the improvement of people's health and progress in society through the development of innovative products.” In contributing to health and society, we recognize that improving access to healthcare is an important social issue that we need to address.
We are working to improve access to healthcare through our efforts to create innovative products, expand access to healthcare, contribute to women's health, strengthen supply chain management, and promote the proper use of our products, which are also our Group's material issues, as well as through collaborations with external parties.
We are expanding its business with a focus on Asia, and will promote our initiatives in collaboration with local partners.

Creation of innovative products

We strive to research and develop pharmaceuticals that meet unmet medical needs, including those that have been evaluated as highly necessary for medical treatment and those that have been requested by academic societies and by the Ministry of Health, Labour and Welfare for development. We are committed to providing innovative pharmaceuticals by promoting open innovation through collaboration with domestic and overseas companies.

Rare disease initiatives

Fertility treatment initiatives

Perinatal Care Initiatives

Thyroid disease initiatives

Pediatric disease initiatives

Donations and Sponsorships

In order to continue to be a group that coexists with local communities, we provide financial support for disaster recovery, poverty, and environmental issues, both in Japan and abroad. Recently, we have made donations to the Keidanren Nature Conservation Fund, the Japan Association for the World Food Programme, and Save the Children.

Ethical Considerations in Research

We are engaged in research and development of pharmaceutical products to contribute to people's health and animal health.
ASKA Pharmaceutical has established internal regulations that comply with the Act on Welfare and Management of Animals and basic guidelines from the Ministry of Health, Labor and Welfare.*1 As well, the Company conducts ethical experiments using animals. All of our experiments are planned with the 3R*2 principles in mind and are examined by animal ethics committees, receive the approval of the director of the implementing organization, and are conducted in laboratories certified by the Association for Assessment and Accreditation of Laboratory Animal Care International*3 (AAALAC International) respectively. We also perform internal inspections once a year. An ethical review committee has been set up to make judgments on using human tissue and on genetic research that confirm the appropriateness of such research.
ASKA Animal Health develops pharmaceutical products with consideration for animal welfare through ethical and scientifically appropriate animal research that eliminates pain, fear, and anxiety in animals under a breeding environment that takes into account the species and habits of the animals.

• *1Basic guidelines for conducting experiments on animals, etc. at implementing organizations under the jurisdiction of the Ministry of Health, Labour and Welfare.
• *2The 3Rs refer to refinement (minimizing animal distress), replacement (using alternative methods), and reduction (reducing the number of animals used).
• *3A private nongovernmental organization that promotes the humane treatment of animals used in science through voluntary review and certification programs.