SUSTAINABILITY

Corporate Governance

Basic Approach to Corporate Governance

Putting that management philosophy to work means leveraging our pharmaceutical development know-how and technologies to achieve the birth and growth of new disease prevention and treatment technologies. That includes not only developing new drugs but partnering with biotechnology ventures, pharmaceutical companies, medical device manufacturers, and other healthcare companies as well as medical institutions around the globe to help bring medical care to new heights, all with a view to turning the hopes of individual patients and society as a whole into reality.

Since our business activities impact people's lives, we demand our officers and employees possess not only professional expertise but also the highest ethical standards to ensure thorough compliance with all laws and regulations as well as our own Code of Conduct. On top of that, we are committed to enhancing our internal controls and ensuring that our operations are sound as well as transparent in order to grow and improve our corporate value.

Overview of Corporate Governance Structure

Linical has built an organizational framework that incorporates an Audit and Supervisory Committee pursuant to the Companies Act of Japan. This will ensure management transparency, strengthen supervisory functions and improve sustainable corporate value through the acceleration of decision-making in business.

In addition, aiming for more rapid decision-making, Linical has also introduced an executive officer system.

Moreover, to ensure the objectivity, transparency and fairness of procedures related to the nomination and remuneration of Directors, etc., and to enhance corporate governance, Linical has established the optional Nomination Committee and Remuneration Committee as advisory bodies.

Board of Directors

Board of Directors

Our Board of Directors comprises a total of twelve members, nine Directors (who are not members of the Audit and Supervisory Board) (including two Outside Directors) and three Directors who are members of the Audit and Supervisory Board (all of whom are Outside Directors), and holds regular meetings monthly, with special meetings of the Board held from time to time as required. The Board is responsible for decision-making involving management policies, annual budgets and other important matters. It also oversees business execution and the business performance of each director through reports on monthly budget management and other important matters. In addition, the two Outside Directors (who are not members of the Audit and Supervisory Board) with extensive knowledge and experience of finance, accounting and the law, and the three Directors who are members of the Audit and Supervisory Board who serve on the Board help ensure sound and effective management.

Audit and Supervisory Committee

Audit and Supervisory Committee

The Audit and Supervisory Committee is comprised of three full-time Directors (all Outside Directors), and holds meetings once a month in principle, and at appropriate times as required. The Audit and Supervisory Committee establishes the division of duties for each member of the Audit and Supervisory Committee, and deliberates on the establishment and operation of the group’s corporate governance and internal control systems, as well as evaluations of the accounting auditor, etc., as its main considerations. In addition, the full-time members of the Audit and Supervisory Committee also attend important meetings, such as meetings of the Management Committee, and conduct audits related to the execution of business, etc.

Management Committee

Management Committee

The Management Committee, whose members are the President and CEO, the Executive Vice Presidents, the Executive Directors and internal Directors, and with Executive Officers and the Directors who are full-time members of the Audit and Supervisory Committee as observers, meets at least once a month. In addition to providing timely solutions to various issues that arise in the execution of business, the Management Committee is intended to deliberate on and communicate with regard to other important management matters, the state of progress of business initiatives and other issues.

Optionally Established Committee Nomination Committee

Optionally Established Committee Nomination Committee

Linical has established a Nomination Committee to ensure appropriate opportunities for Outside Directors to participate in and advise on matters including decision-making regarding the nomination of Directors at meetings of the Board of Directors, to improve objectivity, transparency and fairness of the decision-making process, and to further enhance the corporate governance structure. The Nomination Committee is composed of three or more members who are Directors, the majority of whom are appointed from among the independent Outside Directors, and the chair is appointed from among the independent Outside Directors. Based on inquiries from the Board of Directors, the Nomination Committee deliberates on the appointment and removal of Directors, the selection and removal of Representative Directors and Executive Directors, succession planning and other important matters, and makes recommendations.

Remuneration Committee

Remuneration Committee

Linical has established a Remuneration Committee to ensure appropriate opportunities for Outside Directors to participate in and advise on matters including decision-making regarding the remuneration of Directors at meetings of the Board of Directors, to improve objectivity, transparency and fairness of the decision-making process, and to further enhance the corporate governance structure. The Remuneration Committee is composed of three or more members who are Directors, the majority of whom are appointed from among the independent Outside Directors, and the chair is appointed from among the independent Outside Directors.
Based on inquiries from the Board of Directors, the Remuneration Committee deliberates on the policy and procedures for determining the remuneration, etc., of Directors, the details of the remuneration of individual Directors and other important matters, and makes recommendations.

The members and roles of each committee are as follows.

SCROLL OVER
Title
Name
Board of Directors
Audit & Supervisory Board
Nomination Committee
Compensation Committee
Management Committee
President & CEO & Representative Executive Director
Kazuhiro Hatano
Executive Vice President and Executive Director
Keigo Tsujimoto
Executive Vice President and Executive Director
Jun Kawai
Executive Vice President and Executive Director
Akihiro Takahashi
Executive Vice President and Executive Director
Masaya Miyazaki
Executive Director
Isao Sakamoto
Executive Director
Shiori Yamaguchi
Outside Executive Director
Eri Sugiyama
Outside Executive Director
Satoko Nishimura
Outside Executive Director
Yoshiaki Nakashima
Outside Executive Director
Yuichi Murakami
Outside Executive Director
Yoshimitsu Ando
Senior Executive Officer
Hideshi Ideno
Senior Executive Officer
Satoru Toyota
Senior Executive Officer
Akiko Inomata
Senior Executive Officer
Toshiaki Nagafuji
Executive Officer
Kosuke Yoshida
Executive Officer
Fumihisa Tajima
Executive Officer
Masayoshi Tokuno
CHAIR
MEMBER
OBSERVER

Reasons for Employing a Corporate Governance Structure

As described above, Linical has adopted this structure for the sustainable improvement of the group’s corporate value by ensuring management transparency and the acceleration of decision-making.

The following is a schematic diagram of Linical's corporate governance structure.

Other Matters Related to Corporate Governance

1) Development of an Internal Control System

Linical has established a basic policy as follows with regard to its internal control system, namely the system to ensure that the execution of duties by Directors complies with the law and the Articles of Incorporation, and to ensure the appropriateness of other business of the limited liability company and the corporate group made up of its subsidiaries. The Board of Directors has passed a resolution on this basic policy.

A. Systems to ensure that the execution of duties by Directors and employees complies with the law and the Articles of Incorporation

A. Systems to ensure that the execution of duties by Directors and employees complies with the law and the Articles of Incorporation

  • Linical has established a “Code of Conduct” and provides education on and promotes this code so that Directors and employees can carry out their activities in compliance with the law, the Articles of Incorporation and internal regulations. In addition, Directors and employees sign a document stating that they pledge to comply with the “Code of Conduct” and submit it to the company each year.
  • The President and CEO of the company appoints a Director as the general manager responsible for the compliance system, and this Director promotes and supervises compliance within the organization and strives to ensure compliance with the law and the company’s policies, etc.
  • In addition to the Board of Directors, members of Linical’s Audit and Supervisory Committee participate in important internal meetings to develop the compliance system and confirm the state of its operation.
  • Linical has established an Internal Audit Department as an organization under the direct control of the President and CEO, and this department works with the Audit and Supervisory Committee to monitor the state of compliance with the law and various regulations, and reports to the Board of Directors.
  • Linical has established and operates internal controls related to financial reporting in accordance with standards generally recognized to be fair and appropriate, and evaluates their effectiveness appropriately to ensure the reliability of financial reporting.
  • Linical has established an internal reporting contact based on the “Internal Reporting Manual” to prevent and detect promptly misconduct resulting from violation of the law or other wrong-doing, and strives to ensure public trust. When a report is made, Linical provides thorough protection so that the reporter is not treated disadvantageously due to making the report.
  • In accordance with the “Code of Conduct” and the “Manual for Responding to Anti-Social Forces,” Linical does not respond to unfair or unwarranted demands from anti-social forces, organizations or groups, takes a resolute approach and cuts off all relationships.
  • Linical has established a Nomination Committee and a Remuneration Committee, the majority of whose members are independent Outside Directors, to improve transparency and objectivity related to the nomination of candidates for Director and the determination of the remuneration of Directors and Executive Officers.

B. System for the storage and management of information related to the execution of duties by Directors

B. System for the storage and management of information related to the execution of duties by Directors

Linical records information related to the execution of duties by Directors in documents such as minutes and circulated requests for approval and stores them appropriately in accordance with internal regulations such as the “Board of Directors Regulations,” the “Management Committee Regulations,” the “Business Approval Regulations,” the “Regulations on Administrative Authority,” the “Regulations on the Division of Duties,” the “Regulations on Circulated Requests for Approval” and the “Information Security Management Regulations.” Directors are able to view these documents at all times.

C. Regulations and other systems related to the management of risk of loss

C. Regulations and other systems related to the management of risk of loss

  • Linical anticipates the risks that could affect its business activities and strives to prevent the occurrence of problems. The Risk Management Committee formulates risk management policies and plans for all risks that may affect our corporate activities. Each division identifies risks, looks into risk control measures and responses, and evaluates them every fiscal year. The Risk Management Committee confirms the results of evaluations and reports to the Board of Directors. In addition, with regard to business opportunity risks such as environmental changes and lost opportunities that interfere with sustainable business growth, the President and CEO leads the determination of countermeasures and instructed by the President and CEO, each unit, division, etc., implements measures and reports on their status to the Management Committee. The Management Committee is consulted with regard to important decisions, which are made finally by the Board of Directors.
  • Linical has established a Sustainability Committee to monitor the state of action taken in response to important issues concerning sustainability and report to the Management Committee and the Board of Directors.
  • In the event that a serious risk materializes, we will set up a task force headed by the President and CEO to take measures to minimize damage in accordance with the “Crisis Response Regulations.” In the event of any other significant problem, the Crisis Response Committee will work to resolve the problem.

 

D. Systems to ensure that the duties of Directors are carried out efficiently

D. Systems to ensure that the duties of Directors are carried out efficiently

  • Linical has clarified the administrative authority of Directors and the submission standards for meeting bodies through internal regulations such as the “Board of Directors Regulations,” the “Management Committee Regulations,” the “Business Approval Regulations,” the “Regulations on Administrative Authority,” the “Regulations on the Division of Duties” and the “Regulations on Circulated Requests for Approval” to realize more efficient and appropriate decision-making.
  • In principle, Linical holds a meeting of the Board of Directors once a month, and also holds special meetings of the Board of Directors from time to time as required. In addition, Linical holds meetings of the Management Committee at least once a month to accelerate decision-making by fully considering matters to be submitted to the Board of Directors in advance and making advance decisions on matters to be reported to the Board of Directors.

E. Systems to ensure the appropriateness of business in the corporate group consisting of Linical and group companies

E. Systems to ensure the appropriateness of business in the corporate group consisting of Linical and group companies

  • Linical and its group companies share the “Code of Conduct” and an Ethics and Compliance Program as a basic compliance policy to ensure compliance across the group. In addition, the Compliance Committee implements activities to guarantee that the Linical Group executes business with a high level of ethics and sincerity.
  • Linical and its group companies implement internal controls related to financial reporting in accordance with the Financial Instruments and Exchange Act to ensure the reliability of financial reporting.
  • Linical and its group companies establish risk management systems in accordance with regulations related to risk management.
  • Linical clarifies the objectives to be achieved by the company and its group companies in management plans, and evaluates and manages the state of business execution.
  • Based on the “Regulations on the Management of Affiliates,” Linical receives reports on the operating results and financial data of group companies as well as other important information regularly to grasp their situations.

F. Matters related to employees required by the Audit and Supervisory Committee to assist with its duties

F. Matters related to employees required by the Audit and Supervisory Committee to assist with its duties

Linical’s Board of Directors may, in consultation with the Audit and Supervisory Committee, appoint an employee to assist the Audit and Supervisory Committee if the committee requests an employee to assist with its duties. In addition, if that employee has received instructions from the Audit and Supervisory Committee in relation to their duties, Linical ensures the effectiveness of those instructions.

G. Matters relating to the independence from Directors of the employee of the preceding item (excluding directors who are members of the Audit and Supervisory Committee)

G. Matters relating to the independence from Directors of the employee of the preceding item (excluding directors who are members of the Audit and Supervisory Committee)

The appointed employee is independent from the Directors (excluding directors who are members of the Audit and Supervisory Committee) with regard to the duties designated by the Audit and Supervisory Committee to assist it, and executes those duties under the instructions of the Audit and Supervisory Committee.

H. Systems for Directors (excluding directors who are members of the Audit and Supervisory Committee) and employees to report to the Audit and Supervisory Committee, and other systems for reporting to the Audit and Supervisory Committee

H. Systems for Directors (excluding directors who are members of the Audit and Supervisory Committee) and employees to report to the Audit and Supervisory Committee, and other systems for reporting to the Audit and Supervisory Committee

  • Linical’s Directors report immediately to the Audit and Supervisory Committee if they discover any fact that may cause substantial harm to the company or a subsidiary.
  • Linical’s Directors and employees report on business regularly and as requested by the Audit and Supervisory Committee.
  • Linical’s Directors and employees report important internal communications to the Audit and Supervisory Committee regularly and as required.
  • Linical protects people who report to the Audit and Supervisory Committee so that they are not treated disadvantageously for reason of making such reports.

I. Procedures for advance payment or reimbursement of expenses incurred in connection with the execution of duties by members of the Audit and Supervisory Committee, and other matters concerning policies related to the processing of expenses incurred in connection with the execution of those duties or their reimbursement

I. Procedures for advance payment or reimbursement of expenses incurred in connection with the execution of duties by members of the Audit and Supervisory Committee, and other matters concerning policies related to the processing of expenses incurred in connection with the execution of those duties or their reimbursement

If a member of the Audit and Supervisory Committee requests the advance payment, etc., of expenses required for the execution of their duties, Linical processes such expenses or debts promptly.

J. Other systems to ensure that audits by the Audit and Supervisory Committee are implemented effectively

J. Other systems to ensure that audits by the Audit and Supervisory Committee are implemented effectively

  • Members of the company’s Audit and Supervisory Committee may attend important meetings such as meetings of the Management Committee or the Board of Directors, view important documents related to the execution of business such as circulated requests for approval, and request explanations from Directors and employees in order to grasp important decision-making processes and the state of execution of business. Directors and employees may not block these requests.
  • Linical’s Audit and Supervisory Committee ensures the effectiveness of audits through its independence and authority based on the “Audit and Supervisory Committee Regulations” and the “Audit and Supervisory Committee Standards,” and works closely with Internal Audit Department to ensure the effectiveness of audits by the Audit and Supervisory Committee.

2) Risk Management

The company has established a Risk Management Committee, which is chaired by the Executive Vice President and General Manager of the Administrative Unit to anticipate risks that may affect corporate activities, strive to prevent problems from occurring and deal appropriately with any that do occur. By doing so, we evaluate the risks of business execution, such as disasters, fraud and information leaks, and consider and implement workarounds and countermeasures. In addition, under the direction of President and Representative Executive Director, each business unit and division evaluates business opportunity risks such as environmental changes and lost opportunities that impede sustainable business growth, and considers and implements countermeasures.

The Board of Directors, the Management Committee and the Sustainability Committee also share information with regard to consideration of the above risks, and the Sustainability Committee develops priority measures related to sustainability for the company as a whole, rolls them out internally and monitors their progress, thereby strengthening risk management throughout the company.

Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

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