Internal Control

Internal Control System

The Company has developed various in-house systems and regulations that provide the basis for internal control, and is working to ensure their proper implementation by promoting Groupwide understanding and adherence. Also, the Company has established a structure to monitor whether business operations are conducted appropriately and efficiently based on laws, ordinances and various in-house systems and regulations. This structure is underpinned by the Audit Division, the Internal Affairs Division, the Legal Division, the Financial Division, and the Quality Assurance Management Section.

In connection with internal control of financial reporting operations, relevant divisions periodically conduct self-assessments, and the Audit Division conducts internal audits. Continuous improvement activities are implemented based on the results of these assessments and audits. In addition, the Company has established the Internal Control Assessment Committee as an advisory body to the representative directors for the purpose of issuing reports in accordance with the internal control reporting system of the Financial Instruments and Exchange Act. This committee evaluates the results of self-assessments and internal audits of the status of development and implementation of internal controls for financial reporting, and issues reports on the results of its evaluations to the representative directors.

Resolution Regarding Basic Policy for Creating an Internal Control System

Resolution of the Board of Directors meeting on April 30, 2015

I. Systems to Ensure the Execution of Duties of Directors Conforms to Laws, Regulations and the Articles of Incorporation (Article 362, Paragraph 4, Item 6 of the Companies Act)

The Company is a holding company responsible for coordinating the activities of the group of companies (hereinafter the “Group”) comprising the Company and its subsidiaries (the latter hereinafter collectively referred to as “Group companies”) while also performing management-related administration and supervisory functions. For greater success in achieving its full range of objectives, the Company, as a whole, will make efforts to increase its corporate value while considering its corporate social responsibilities and relationships with shareholders and other stakeholders. Based on this approach, the Company will establish a system, in line with the following, to ensure that the execution of duties by directors of the Company complies with laws, regulations and the Articles of Incorporation.

  1. The Board of Directors shall decide the Group’s basic management policies and be responsible for supervising the execution thereof. At the same time, the directors shall execute their duties in accordance with these policies, and in compliance with laws and regulations with due care and diligence. While noting the roles and responsibilities of each internal body and the coordination thereof, the directors shall share information within the Group and shall provide proper disclosure of information to shareholders and society at large.
  2. The directors shall implement the Group’s corporate mission, which is “to contribute to society by creating and offering superior pharmaceuticals and health-related products as well as healthcare-related information and services in socially responsible ways that enrich people’s lives by improving health and beauty”; the Declaration of Corporate Conduct, which sets forth principles of conduct based on the long-held tradition of shinsho (“gentlemanly business”), a hallmark of the Company’s corporate culture; and the Code of Conduct, which provides specific guidelines with respect to the above principles.
  3. In accordance with the above, the Board of Directors shall develop systems that ensure effective and efficient internal controls throughout both the Company and Group companies, from the standpoint of legal compliance, ensuring the reliability of financial reporting, raising operating efficiency, and preserving the value of assets, among other priorities.

II. Systems for Ensuring the Efficient Execution of Duties by Directors (Article 100, Paragraph 1, Item 3 of the Ordinance for Enforcement of the Companies Act)

The Company shall adopt a management team of a scale sufficient to facilitate agile responses to changes in the Group’s business environment, management strategies and economic conditions as well as laws, regulations and other rules. The Board of Directors shall decide on the Group’s basic management policies and strategies, as well as important matters related to business execution. The Company shall strive to centralize and raise the efficiency of directors’ execution of duties by assigning and coordinating roles among corporate bodies such that directors responsible for operations fulfill an executive role in those operations. Furthermore, the Company will endeavor to raise the efficiency of the execution of duties by having directors perform duties according to organizational rules and rules on job roles and responsibilities.

III. Systems Concerning Storage and Management of Information Related to the Execution of Duties by Directors (Article 100, Paragraph 1, Item 1 of the Ordinance for Enforcement of the Companies Act)

The Company properly stores and manages information regarding decision-making processes at shareholders’ meetings, Board of Directors meetings, and other important meetings and the execution of important decisions. This is accomplished by recording and storing information in writing or electronic recording media based on a system of rules including rules on document management and digitization of information. The Company also conducts training and monitoring of employees, among other measures. In addition, the Company requires subsidiaries to properly store and manage documents, including electronic recording media, concerning the execution of duties by directors in the same manner as the Company, and assists with this process.

IV. Systems to Ensure the Execution of Duties by Employees Conforms with Laws, Regulations and the Articles of Incorporation (Article 100, Paragraph 1, Item 4 of the Ordinance for Enforcement of the Companies Act)

  1. The Chief Executive Officer shall formulate the Group’s Declaration of Corporate Conduct and Code of Conduct, clearly stating the Company’s basic policy on compliance with laws and regulations. Moreover, the Company shall establish a compliance structure as described below to ensure that the execution of duties by employees conforms with laws, regulations and the Articles of Incorporation.
    1. (1)By formulating the Compliance Rules, the Company shall clarify the organizational structure and operational procedures for compliance activities. The Company shall implement guidance and training on the Compliance Rules within the scope of responsibility of the divisional managers. The Company shall also assess and investigate whether compliance activities are properly implemented and work to make improvements.
    2. (2)In cases where the conformity of business execution processes with laws, ordinances, regulations, rules, the Articles of Incorporation and so forth is in question, all employees shall be permitted to consult with the Legal Division or to obtain legal advice as necessary. In order to enhance the effectiveness of compliance, the Company shall also establish internal and external compliance hotlines via telephone, electronic means, or in writing to field compliance consultations and to function as a whistleblower system.
    3. (3)The Company shall continue to make improvements to the aforementioned Declaration of Corporate Conduct, Code of Conduct and other internal rules of the Group in areas that require correction without delay. At the same time, to ensure continued compliance therewith, the Company shall implement compliance education and training activities.
  2. In regard to anti-social forces, the Company shall establish a division responsible for responding to such entities, closely cooperate with external specialist agencies and other organizations, and gather information related to anti-social forces. In this manner, the Company shall develop a system for resolutely rejecting any illegitimate and unlawful requests while ensuring there are no relations with anti-social forces.

V. Rules Concerning the Management of the Risk of Losses and Other Related Systems (Article 100, Paragraph 1, Item 2 of the Ordinance for Enforcement of the Companies Act)

To ensure the ability to respond to the risk of losses, the Company’s Risk Management Coordination Section shall establish a rule-based system to coordinate and manage the divisions of the Company.

  1. The Board of Directors and Management Advisory Committee of the Company shall respond to those risks of losses that concern management, and shall manage and assist various divisions in this respect.
  2. The Company’s Risk Management Coordination Section shall take the lead in developing a risk management framework addressing all risks of the Company other than (1) above that could have a material impact on the Group, as well as major natural disasters, major accidents, and similar risks.
  3. The headquarters and divisions shall develop a risk management framework for those risks other than (1) and (2) above that can reasonably be addressed by headquarters and divisions, after identifying, assessing and examining each type of risk. The Risk Management Coordination Section shall inspect, advise and provide guidance on such activities.
  4. In the event that the risk of losses materializes, the divisions involved with the relevant risk shall respond in a cooperative manner.
  5. With respect to risks associated with violations of laws and regulations, product quality, information security, leaks of confidential information (including personal information), collection of accounts receivable, and the environment and risk of losses stemming from foreign laws, regulations and other rules, the relevant divisions and other entities responsible for each area shall develop and implement response measures to each risk based on the advice and guidance of each company’s Risk Management Coordination Section. In addition, each division shall establish rules, guidelines and so forth for each field, while passing these down to all employees through education and training programs as well as the distribution of manuals and through other means.

VI. Systems to Ensure Proper Operations by the Group of Companies Comprising the Relevant Company as well as Its Parent Company and Subsidiaries (Article 100, Paragraph 1, Item 5 of the Ordinance for Enforcement of the Companies Act)

  1. The Company shall establish rules for the management of Group companies. Based on these rules, while giving consideration to the scale and attributes of each subsidiary such as whether the subsidiary is publicly listed on a stock exchange, whether the subsidiary is based in Japan or overseas, and the Company’s investment ratio, the Company will establish a system to ensure proper operations for the Group as a whole, as follows:
    1. (1)In cases where subsidiaries are classified as large companies as stipulated by the Companies Act, an internal control system equivalent to that of the Company shall be established at the relevant subsidiary. Regarding other companies in the Group, the extent of control by the Company, the nature of each company’s business operations, and the details of laws and regulations applicable to each company shall be examined closely, and a system for ensuring proper operations shall be considered for each relevant company.
    2. (2)Based on this process, the Company shall clearly identify which aspects shall be managed in a unified manner as a holding company, and which aspects shall be managed separately. To ensure proper operations throughout the Group, the Company shall establish a system mainly focused on enhancing communication channels and audit systems.
    1. (1)System for reporting to the group of companies comprising the relevant company about items regarding the execution of duties by the directors and others of subsidiaries
      The Company will establish a system between subsidiaries according to the scale and attributes of each subsidiary to report the overall business content and content of important individual duties to subsidiaries, and to hold meetings and prepare reports on a regular basis or whenever necessary.
    2. (2)Rules concerning the management of the risk of losses of subsidiaries and other systems
      To ensure the ability to respond to the risk of losses related to the Group overall, the Company shall establish a rule-based system as the Group’s management to enable the Company’s Risk Management Coordination Section to coordinate and manage the risk management divisions of subsidiaries. Moreover, it shall establish a system that in the event that a risk of losses materializes, the divisions of the Company and its subsidiaries involved with the relevant risk shall respond in a cooperative manner.
    3. (3)System to ensure the efficient execution of duties by the directors and others of subsidiaries
      The Company shall formulate policies for the business execution of the Group overall, and the Company shall advance the specialization of work duties through a framework of collaboration, and strive to centralize and raise the efficiency of the business execution by assigning and coordinating roles among Group companies such that each subsidiary executes business in line with this policy. Moreover, for relevant targets, the specialized divisions of the Company shall cooperate with the directors and others of subsidiaries in raising the efficiency and improving detailed business execution in each field of responsibility.
    4. (4)System to ensure the execution of duties by directors and others of subsidiaries conforms with laws, regulations and the Articles of Incorporation
    1. a.In the course of subsidiaries’ business operations and in an effort to prevent the occurrence of violations of various business-related laws, regulations, guidelines or other standards, the Company shall cooperate in establishing an effective compliance system for subsidiaries, and in accordance with the attributes of and necessity for the subsidiaries, shall collect and provide data, administer business inspections, monitor and provide other necessary assistance.
    2. b.In regard to anti-social forces, the Company shall manage and assist all subsidiaries to develop systems identical to those at the Company for resolutely rejecting any anti-social forces.

VII. Items Concerning Employees Assigned to Assist with the Duties of Audit & Supervisory Board Members at the Request of Audit & Supervisory Board Members (Article 100, Paragraph 3, Item 1 of the Ordinance for Enforcement of the Companies Act)

The Company shall establish the Audit & Supervisory Board Members’ Office and an operational support system for the Audit & Supervisory Board members and the Audit & Supervisory Board, such as by assigning dedicated employees to assist with the duties of Audit & Supervisory Board members.

VIII. Items Concerning the Independence of Employees Described in Section VII Above from the Directors (Article 100, Paragraph 3, Item 2 of the Ordinance for Enforcement of the Companies Act)

To ensure the independence of employees assisting with the duties of the Audit & Supervisory Board members from the directors, the Company shall assign the relevant dedicated employees after discussing the matter with the Audit & Supervisory Board members based on the rules of the Audit & Supervisory Board Members’ Office, and the opinions of the Audit & Supervisory Board members concerning personnel considerations, personnel transfers and disciplinary measures of the relevant employees shall be respected.

IX. Items to Ensure the Effectiveness of Instructions from Audit & Supervisory Board Members to the Employees Described in Section VII Above (Article 100, Paragraph 3, Item 3 of the Ordinance for Enforcement of the Companies Act)

To ensure the effectiveness of the instructions of Audit & Supervisory Board members given to employees who are assisting the Audit & Supervisory Board members’ duties, Audit & Supervisory Board members shall lead and supervise the relevant employees, who shall observe the stipulations of laws, regulations, rules, the Articles of Incorporation and other guidelines, as prescribed by the rules of the Audit & Supervisory Board Members’ Office. Moreover, in the case of addressing improvements in the actions of relevant employees, directors and employees shall do this through the Audit & Supervisory Board members.

X. 1) Systems to Ensure Reporting to the Audit & Supervisory Board Members by Directors and Employees, 2) Systems to Ensure Reporting to the Audit & Supervisory Board Members by Directors, Audit & Supervisory Board Members and Employees of Subsidiaries and Those Who Have Received Reports from These People and 3) Other Systems Concerning Reporting to the Audit & Supervisory Board Members (Article 100, Paragraph 3, Item 4 of the Ordinance for Enforcement of the Companies Act)

Based on the Rules for Communication and Reporting to the Audit & Supervisory Board Members and Audit & Supervisory Board, the Company shall establish a system for the directors and employees to report to the Audit & Supervisory Board members.

  1. System for the directors and employees of the Company and the directors, Audit & Supervisory Board members and employees of its subsidiaries to report to the Audit & Supervisory Board or the Audit & Supervisory Board members of the Company, and for the directors and employees of the Company who have received reports from the directors, Audit & Supervisory Board members and employees of its subsidiaries to report to the Audit & Supervisory Board or the Audit & Supervisory Board members of the Company.
  2. The Company shall also establish a system that governs the responses of directors, Audit & Supervisory Board members and employees in the event that Audit & Supervisory Board members of the Company ask directors and employees of the Company or directors, Audit & Supervisory Board members and employees of its subsidiaries questions or request the submission of documents and reports.
  3. The Company shall also establish a system that governs audits and attendance in meetings when such attendance in internal meetings, etc., of the Company is deemed necessary by the Audit & Supervisory Board members and enables the viewing of minutes of those meetings.

Moreover, the Audit & Supervisory Board members shall endeavor to cooperate and share information within the necessary scope with the accounting auditors and their assistants as well as the Audit Division and others.

XI. Systems to Ensure That People Who Reported under Section X Above Do Not Receive Unfavorable Treatment as a Result of These Reports (Article 100, Paragraph 3, Item 5 of the Ordinance for Enforcement of the Companies Act)

To discover misconduct or suchlike at an early stage and rectify it, the Company shall prohibit the dismissal, demotion, salary reduction, cancellation of temporary work contracts, and any other forms of unfair treatment or harassment to ensure that people who reported under section X above do not suffer because of these reports, and the Company and its subsidiaries shall rigorously punish anyone who conducts such harassment or similar actions in accordance with employment regulations.

XII. Items Related to Policies Regarding the Prepayment of Expenses Incurred by Audit & Supervisory Board Members in the Execution of Their Duties and Regarding the Treatment of Expenses or Loans Generated by the Execution of Redemption Procedures and Other Relevant Duties (Article 100, Paragraph 3, Item 6 of the Ordinance of Enforcement of the Companies Act)

With the aim of contributing to the smooth and effective operation of the Audit & Supervisory Board members’ audits, the Company has arranged that the Audit & Supervisory Board members independently conduct surveys and other measures that are deemed appropriate at the Company’s expense. Moreover, the Audit & Supervisory Board members may obtain the opinions of lawyers, certified public accountants and other external experts at the Company’s expense, except when such advice is not deemed necessary to their auditing duties.

XIII. Other Systems to Ensure the Effective Implementation of Audits by Audit & Supervisory Board Members (Article 100, Paragraph 3, Item 7 of the Ordinance for Enforcement of the Companies Act)

To ensure the effective implementation of audits by the Audit & Supervisory Board members, the Company shall establish a system to ensure that the Audit & Supervisory Board members of the Company have adequate access to the Company and its subsidiaries as well as receive adequate communication and reporting from the directors and employees of the Company and the directors, Audit & Supervisory Board members and employees of its subsidiaries with respect to the following information and facts, based on the Rules for Communication and Reporting, to the Audit & Supervisory Board Members and Audit & Supervisory Board.

  1. Situations where the Group is likely to incur substantial losses, or the relevant facts when such losses have materialized
  2. Situations where violations of laws, regulations or the Articles of Incorporation or misconduct may occur, or the relevant facts when such violations have occurred
  3. Situations where product safety, information security, environmental or other issues may occur, or the relevant facts when such issues have occurred
  4. Other situations in which events equivalent to those in items (1) to (3) above may occur, or the relevant facts when such events have occurred