The CMIC Group defines important rules, principles, and management responsibilities for the entire group as Policies. These Policies applies to all officers, employees and dispatched employees within the CMIC Group. In addition, all or part of these also apply to agents, consultants, contractors, and other third parties working on behalf of CMIC Group, as specified in the contract.

CMIC Group Quality Policy CMIC Group Top Management has defined the following Quality Policy, to demonstrate commitment to establish and implement an integrated Quality Management System. CMIC Group aims to provide continually high quality services and products to our customers in order to meet their expectations.

  • Ensure our customers’ needs and expectations are continually monitored
  • Set our Quality Objectives
  • Establish effective and efficient operating processes
  • Ensure continual improvement in our processes and procedures
  • Enhance competence of all employees

Established March 1, 2020

Introduction
The Mission of the CMIC Group (“We”) is ” CMIC is an innovative and unique provider of high-quality solutions for the healthcare industry. We create value by accelerating the access to therapies that improve patients’ lives.”

In accomplishing this mission, we will comply with the fundamental principles of conduct set forth in the CMIC Group Code of Conduct and observe the following items with respect to ethics, labor, safety, health, environment and related management systems in accordance with the Pharmaceutical Industry Principles for Responsible Supply Chain Management (the “Principles”).

Ethics
We conduct our business ethically and act with integrity. The Ethics elements include:

1. ANTI-BRIBERY AND CORRUPTION
All forms of bribery, corruption*, extortion and embezzlement are prohibited. We do not pay or accept bribes or participate in other illegal inducements in business or government relationships, or through the use of intermediaries. We ensure that we have adequate systems in place to prevent bribery and comply with applicable laws.

2. FAIR COMPETITION
We conduct our business consistent with fair and vigorous competition and in compliance with all applicable anti-trust laws. We employ fair business practices including accurate and truthful advertising.

3. ANIMAL WELFARE
Animals shall be treated humanely with pain and stress minimized. Animal testing should be performed after consideration to replace animals, to reduce the numbers of animals used, or to refine procedures to minimize distress. Alternatives should be used wherever these are scientifically valid and acceptable to regulators.

4. DATA PRIVACY AND SECURITY
We safeguard and make only proper use of confidential information to ensure that company, worker, patient, subject* and donor* privacy rights are protected. We comply with applicable privacy and data protection laws and ensure the protection, security and lawful use of personal data.

5. PATIENT SAFETY AND ACCESS TO INFORMATION
We ensure that adequate management systems are in place to minimize the risk of adversely impacting on the rights of patients, subjects and donors, including their rights to health and to access information directly.

6. CONFLICTS OF INTEREST
We take reasonable care to avoid and manage conflicts of interest.

Human Rights and Labor
We are committed to uphold the human and employment rights of workers and to treat them with dignity and respect. The Labor elements include:

1. FREELY CHOSEN EMPLOYMENT
We do not use forced, bonded or indentured labor or involuntary prison labor. No worker shall pay for a job or be denied freedom of movement.

2. CHILD LABOR AND YOUNG WORKERS
We do not use child labor. The employment of young workers below the age of 18 shall only occur in non-hazardous work and when young workers are above a country’s legal age for employment or the age established for completing compulsory education.

3. NON-DISCRIMINATION
We provide a workplace free from discrimination. There shall be no discrimination for reasons such as race, color, age, pregnancy, gender, sexual orientation, ethnicity, disability, religion, political affiliation, union membership or marital status.

4. FAIR TREATMENT
We provide a workplace free of harassment, harsh and inhumane treatment, including any sexual harassment, sexual abuse, corporal punishment, mental or physical coercion or verbal abuse of workers and no threat of any such treatment.

5. WAGES, BENEFITS AND WORKING HOURS
We pay workers according to applicable wage laws, including minimum wages, overtime hours and mandated benefits.

We communicate with the worker the basis on which they are being compensated in a timely manner. We are also expected to communicate with the worker whether overtime is required and the wages to be paid for such overtime. Overtime shall be consistent with applicable national and international standards.

6. FREEDOM OF ASSOCIATION
Open communication and direct engagement with workers to resolve workplace and compensation issues is encouraged.

We respect the rights of workers, as set forth in local laws, to associate freely, join or not join labor unions, seek representation and join workers’ councils. Workers shall be able to communicate openly with management regarding working conditions without threat of reprisal, intimidation or harassment.

Health and Safety
We provide a safe and healthy working environment, including – where applicable – for any company-provided living quarters. Health and Safety measures shall extend to contractors and subcontractors on supplier sites. The Health and Safety elements include:

1. WORKER PROTECTION
We protect workers from over exposure to chemical, biological, physical hazards and physically demanding tasks in the workplace and in any company provided living quarters. We ensure appropriate housekeeping and provide workers with access to potable water.

2. PROCESS SAFETY
We have management processes in place to identify the risks from chemical and biological processes and to prevent or respond to catastrophic release of chemical or biological agents.

3. EMERGENCY PREPAREDNESS AND RESPONSE
We identify and assess emergency situations in the workplace and any company provided living quarters, and to minimize their impact by implementing emergency plans and response procedures.

4. HAZARD INFORMATION
Safety information relating to hazardous materials – including pharmaceutical compounds and pharmaceutical intermediate materials – shall be available to educate, train, and protect workers from hazards.

Environment
We operate in an environmentally responsible and efficient manner to minimize adverse impacts on the environment. We are encouraged to conserve natural resources, to avoid the use of hazardous materials where possible and to engage in activities that reuse and recycle. The Environmental elements include:

1. ENVIRONMENTAL AUTHORIZATIONS AND REPORTING
We comply with all applicable environmental regulations. All required environmental permits, licenses, information registrations and restrictions shall be obtained, and their operational and reporting requirements followed.

2. WASTE AND EMISSIONS
We have systems in place to ensure the safe handling, movement, storage, disposal, recycling, reuse, or management of waste, air emissions and wastewater discharges. Any waste, wastewater or emissions with the potential to adversely impact human or environmental health shall be appropriately managed, controlled and treated prior to release into the environment. This includes managing releases of active pharmaceuticals into the environment (PiE).

3. SPILLS AND RELEASES
We have systems in place to prevent and mitigate accidental spills and releases to the environment and adverse impacts on the local community.

4. RESOURCE USE
We take measures to improve efficiency and reduce the consumption of resources.

5. SUSTAINABLE SOURCING AND TRACEABILITY
We carry out due diligence on the source of critical raw materials to promote legal and sustainable sourcing.

Management Systems
We use management systems to maintain business continuity, facilitate continual improvement and compliance with the expectations of these Principles. The Management System elements include:

1. COMMITMENT AND ACCOUNTABILITY
We demonstrate commitment to the concepts described in this document by allocating appropriate resources and identifying senior responsible personnel.

2. LEGAL AND CUSTOMER REQUIREMENTS
We identify and comply with applicable laws, regulations, standards and relevant customer requirements.

3. RISK MANAGEMENT
We have mechanisms to determine and manage risks in all areas addressed by these Principles.

4. DOCUMENTATION
We maintain documentation necessary to demonstrate conformance with these Principles and compliance with applicable regulations.

5. TRAINING AND COMPETENCY
We have a training program that achieves an appropriate level of knowledge, skills and abilities in management and workers to address the expectations in these Principles.

6. CONTINUAL IMPROVEMENT
We are expected to continually improve by setting performance objectives, executing implementation plans and taking necessary corrective actions for deficiencies identified by internal or external assessments, inspections, and management reviews.

7. IDENTIFICATION OF CONCERNS
All workers shall be encouraged to report concerns, illegal activities or breaches of these Principles in the workplace without threat of or actual reprisal, intimidation or harassment. We investigate and take corrective action if needed.

8. COMMUNICATION
We have effective systems to communicate these Principles to workers, contractors and suppliers.

CMIC Group complies with laws and regulations, etc. concerning the prohibition of bribery and corruption applicable to the countries and regions in which our businesses are being operated, and establishes a system, and thereby executes our businesses under highly ethical standards properly.

  1. Prohibition of Bribery
    In the process of business activities, we will neither directly or indirectly, to obtain business benefit or secured, offer, promise, or provide money, gifts, recreation and other benefit to any other parties including public officers and medical personnel. We will not act in a way that would cause suspicion of such actions as well.
  2. Prohibition of Acceptance of Bribes
    We will not use our business positions to demand, promise to accept, or receive money, gifts, entertainment, or other benefits, either directly or indirectly, that have been intended to exert an unjust influence on our judgments or acts nor in return for making unjustifiable judgments or doing improper acts. We will not act in a way that would cause suspicion of such actions as well.
  3. Measures to Prevent Bribery
    By implementing the following measures, an act of bribery will be prevented:
    1. Dissemination of the Policy to Executives and Employees, and thorough and periodic review of compliance
    2. Implementation of education and training to prevent bribes
    3. Implementation of monitoring
    4. Proper reports of and responses to bribery type acts

The trading partners who are involved in the CMIC Group’s business also should be asked to take the above actions as well.

CMIC Group complies with the laws, regulations, and guidelines related to animal welfare and applies the “3R” practice explained below in regard to tests using animals bred or managed at the facilities of CMIC Group, based on the spirit of animal welfare. In addition, as a “Plus 1R,” the test manager or the breeding manager is accountable for the test or breeding management.

CMIC Group obtains and maintains full certification from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), so our performance will be verified by a third party.

3R Practice

  1. Replacement

We look at scientific and technological information that is advancing day by day and adopt alternative test methods as much as possible.

  1. Reduction

We will not carry out unnecessary experiments, will set an appropriate number of animals based on science and technology, and will reduce the number of animals used.

  1. Refinement

During the breeding period, we will strive to reduce stress on the animals by providing a comfortable breeding environment, formulate an appropriate experimental plan, and not cause unnecessary pain to the animals.

Plus 1R

  1. Responsibility

The test manager will prepare a plan and obtain approval from an Institutional Animal Care and Use Committee (IACUC) whenever using animals. The breeding manager will report to IACUC on the situation and improvement of the breeding environment.

CMIC Group Top Management has established the following Information Security Policy to safeguard and properly utilize its information resources so as to continuously grow as trusted partner to our customers.

  1. Establishment of Information Security Management System
    CMIC Group Top Management will assume the ownership of information resources and take leadership in the establishment and operation of information security management systems.
  2. Compliance Measures
    All employees of CMIC Group will comply not only with the applicable laws and regulations but also with socially accepted ethical norms, and appropriately manage and utilize information resources by ensuring confidentiality, integrity, and availability.
  3. Periodical Evaluation of Information Security Measures
    CMIC Group will continuously update and improve the information security measures through periodical evaluations by internal audit and management review.
  4. Raising Awareness of Information Security
    CMIC Group Top Management will continuously promote raising awareness of information security in all employees.
  5. Partnership
    CMIC Group respects its partnership with its customers, and will respond honestly and with good faith to customers by making efforts to continuously improve information security measures.

CMIC Group
Kazuo Nakamura, CEO

CMIC Group Top Management has recognized the importance of personal data dealt with in our business development scene and will protect the personal data according to the following principles.

1. Collection of Personal Data

Personal data is collected in a legal and fair manner.

In CMIC Group, we collect personal data in legal and fair manner as well as obtaining prior consent by notifying or publicly announce of our purpose.

2. Use of Personal Data and Purpose Specification

Personal data is used within the range of the explicit purpose of usage.

In CMIC Group, the collected personal data is used within the range of the purpose notified or announced in advance. For cases to exceed the range, the prior consent shall be obtained.

3. Data Quality and Security Safeguards of Personal Data

Rational security countermeasures are taken in order to maintain the accuracy of personal data and to secure safety.

In CMIC Group, we will endeavor to keep personal data accurate and up to date. For cases we delegate handling of personal data to the external vendors, we select vendors who can follow our personal data protection guideline stipulated in advance and also confirm the management status.

4. Control of Personal Data Principle

In-house structure/system for controlling personal data is maintained and adequately functioning.

In CMIC Group, we clarify the responsible person and also establish the system structure in order to handle the personal data is adequately managed. With the managing system, we handle the request from the individuals such as to providing the collected fact, location, purpose of the usage, information of the responsible personnel a personal information of the individuals.

5. Compliance with Local Regulations relating to the Personal Data Protection Principle

Personal data is handled in compliance with applicable national legislation like Laws, Ordinances, and other Regulations of each country.

In each company in CMIC Group, we follow regulations regarding personal data in each country. We also comply with regulations applicable beyond the countries or regions like GDPR. (Click here to read our GDPR compliance policy >>)

CMIC Group complies with laws and regulations relating to Conflict of Interest, or various rules relating to the business, applicable to the countries and regions in which our businesses are being operated, and establishes a system, and thereby executes our businesses under highly ethical standards properly.

  1. Conflict of Interest Management
    “Conflict of Interest” means the state in which the personal interests of Executives and Employees exist that damage or pose a risk of damaging the legitimate interests of the business of CMIC Group. All of the Executives and Employees understand and recognize these Conflicts of Interest actually arise or could arise, and in cases when such Conflicts of Interest arise, they should appropriately manage and deal with them, and avoid Conflicts of Interest.
  1. Appropriate Reporting, Consultation, and Management
    By implementing the following measures, CMIC Group shall endeavor to understand, manage, deal with and avoid Conflicts of Interest:
    1. Dissemination of the Policy to Executives and Employees, and thorough and periodic review of compliance
    2. Implementation of education and training on Conflicts of Interest
    3. Implementation of monitoring
    4. Proper reports of and responses to Conflicts of Interest

In CMIC’S CREED, our corporate philosophy, the CMIC Group is committed to bring innovation to healthcare so that all people, regardless of age, gender or race, can live their one and only lives according to their own will. To achieve this, we shall respect the human rights of all stakeholders.

  1. Basic Approach to Human Rights
    We understand that our business activities may affect human rights and promise to respect them. To this end, we will support and respect the following international norms.

    • International Bill of Human Rights, which stipulates the fundamental human rights of all people (Universal Declaration of Human Rights, International Covenant on Civil and Political Rights, International Covenant on Economic, Social and Cultural Rights)
    • ILO Declaration on Fundamental Principles and Rights at Work (including the core labor standards of prohibition of child labor, prohibition of forced and compulsory labor, elimination of discrimination and recognition of the right to freedom of association and collective bargaining) of the International Labor Organization (ILO), which provides for fundamental rights at work
    • Convention on the Rights of Workers, including Wages and Working Hours
    • United Nations Declaration on the Rights of Indigenous Peoples
    • United Nations Global Compact Ten Principles
    • “Ethical Principles of Medical Research for Human Subjects (Declaration of Helsinki)”
  2. Comply with national laws and regulations
    We will comply with the human rights laws of each country and regions in which we operate. In addition, if the laws and regulations of the relevant country do not correspond to international norms, we will comply with higher standards, and if there is a conflict, we will seek ways to find common ground.
  3. Human rights in the workplace
    We will respect diversity, prohibit all forms of discrimination and harassment, and comply with laws and labor practices domestically and internationally. In addition, we will promote diversity and inclusion and create a safe and rewarding work environment so that employees can work with peace of mind.
  4. Training on human rights
    Regular educational sessions are provided to all directors and employees. Separate training sessions for management are also provided.
  5. Human rights remedies
    In the event of a human rights breach in connection with our business activities, we will take remedial measures by grasping the situation and taking appropriate measures.

We seek the understanding of our human rights philosophy among our business partners who are involved in the business of the CMIC Group.

CMIC Group recognizes that corporate activities that preserve the environment and ensure the health and safety of employees (Environment, Health, and Safety, hereinafter called “EHS”) are vital management issues for carrying out the mission of the CMIC Group, and will take the initiative in establishing an EHS system.

  1. Basic Attitude toward Activities
    Through all our business activities, we place top priority on environmental preservation and employee health and safety, and are committed to systematic and continuous efforts for this purpose.
  2. Compliance with Laws and Regulations
    We comply with local laws, regulations, and regional agreements on EHS to meet stakeholder expectations.
  3. Clarification of Responsibilities and Continuous Improvement
    We clarify our roles and responsibilities for the organization to promote environmental preservation and ensure the health and safety of employees, and make continuous improvements to them.
  4. Dissemination and Education
    We make the activities for EHS known to all employees through providing education and information.
  5. Information Disclosure
    We will actively disclose information relating to environmental and health and safety activities and endeavor to improve society’s trust in us.

The trading partners who are involved in the CMIC Group’s business also should be asked to take the above actions as well.

All information provided on this Web site is not intended to solicit purchase or selling of the shares of CMIC HOLDINGS Co., Ltd.

Neither the Company nor the informant will accept any liability for any loss whatsoever arising from the use of this information.

Each recipient of the information shall be solely responsible for making its own investment decision.

Please be aware that information will not necessarily reflect the latest situation.

Basic Disclosure Policy

The Company discloses important information such as management decisions, corporate events and information related to earning results that will affect investment decisions, in compliance with the regulation of timely disclosure set by the Tokyo Stock Exchange.

The Company’s basic disclosure policy is to fairly, promptly and extensively disclose information, including ones that are not required by this regulation, to satisfy investors and security analysts.

The Method of Disclosure

Important information that applies to the regulation of timely disclosure set by Tokyo Stock Exchange will be registered in the TDnet system provided by the TSE, in compliance with the regulation.

After the registration, the Company will provide the same information to the news media as well as posting it on the Company’s Web site.

When disclosing information that does not apply to the regulation of timely disclosure, the Company makes special considerations to ensure that information will be delivered as fairly as possible through the Web site and news media.

Timely Disclosure of Important Information

In compliance with Articles 2, 3 and 4 of the regulation on timely disclosure set forth by the Tokyo Stock Exchange, the Company will disclose in a timely manner information regarding management decisions, corporate events, financial results, or when the Company receives inquiries by the TSE, or when there are important changes or cancellations in corporate data already disclosed.

Voluntary Disclosure Items

The Company actively discloses information that does not apply to the regulation of timely disclosure but is determined by the Company to be useful for investment decisions.

Specifically, the Company discloses such information as mid-to long-term management strategies, supplementary data and presentation materials from results briefings, etc.

In addition to earning results disclosures through semi-annual earnings briefings, the Company also discloses quarterly reports on consolidated earning results in compliance with the regulation on timely disclosure.

Earnings Forecast and Relevant Materials

The Company occasionally provides the outlook on future earnings in addition to the earnings forecast contained in earnings briefings.

Press reports, results briefings, various materials and Q&A may include a forecast or view on future earnings.

In any case, all forward-looking information is based on the Company’s decision at the time of its creation under certain assumptions.

Therefore, information on the future earnings will be subject to change without advance notice due to changes in assumptions, and actual earnings may differ materially from the forecast due to various factors.