Maruho Code of Compliance Standards

Maruho Co., Ltd. hereby establishes this Code of Compliance Standards, and its officers and employees shall comply with this Code in their own conduct and their activities conducted as company business.

Ⅰ. Fundamental Policy

1. Basic stance

  • (1) Our mission, as one who handles pharmaceutical products, i.e. products that impact health and life, is to contribute to a high quality of life and the health of people. For that purpose, in carrying out business activities, we shall comply with general laws and regulations such as civil codes, corporate laws and anti-monopoly laws, as well as the various business-related laws and regulations such as pharmaceutical laws, GLP, GCP, GMP, GQP, GVP and GPSP. Moreover, we shall act with high ethical standards, including bioethics, and good sense, and each individual shall conduct him/herself with self-awareness and an understanding of one’s own mission.
  • (2) When we commission work to group companies or outside vendors in regards to various processes, such as product research, development, manufacturing and sales, we shall be aware that we are the ones that bear the ultimate responsibility, and shall handle situations with a sense of unity with the group company or outside vendor.

2. Contributing to Social Participation and Development

  • (1) We shall appropriately and in a timely manner disclose information necessary to society, and shall listen attentively to the voice of society and strive to communicate with society.
  • (2) We shall strive for transparency in our business activities, demonstrate respect and a spirit of integrity and fairness in our dealings with patients, medical professionals and business partners, and shall work to provide products and services in response to needs.
  • (3) We shall strive to strengthen corporate governance and establish internal control systems to ensure proper business operations and compliance with laws and regulations, aiming to create a company that develops together with its shareholders.
  • (4) In carrying our business activities, we shall strive to harmonize with our operations in light of the cultures, religions, traditions and other characteristics of local residents and communities. We will work to win the mutual trust of our stakeholders, cooperate and collaboration with them, and to contribute to the development of society.
  • (5) We support the volunteer activities of our employees.

3. Compliance with our articles of incorporation and internal rules

We shall adequately understand and comply with the gist and contents of our company’s articles of incorporation, corporate activity charter, the Maruho Code of Compliance Standards and internal rules.

4.Internal Reporting

  • (1) If a violation is discovered or suspected of any relevant laws and regulations in Japan and overseas, voluntary codes of the industry, and internal regulations, we will promptly notify the supervisor of the department to which we belong to of such violation or alleged violation, by making inquiries, consulting with, or reporting to the compliance hotline contact.
  • (2) We shall respond appropriately to inquiries, inquiries, reports, or internal reports about violations of or suspected violations of applicable laws and regulations in Japan and overseas, voluntary codes of the industry, and internal regulations. In addition, the Group does not treat whistleblowers, etc. as disadvantageous due to the fact that they did not search for anyone and cooperated in reporting and investigations, etc
  • (3) We respond in good faith to any inquiries, consultations, or reports from retirees or business partners regarding internal reports.

Ⅱ. Business Activities

5. Drug Discovery Research

  • (1) We shall actively engage in research of new medical products and pharmaceutical technology in order to overcome illnesses and to maintain and improve healthy lifestyles for people, as well as to make high quality contributions to the progress of medical care. In addition, we shall ascertain needs in fields lacking appropriate treatment drugs and needs for clinically-necessary medical products, and keep that in mind as we conduct investigations and research activities.
  • (2) We shall always confirm whether or not substances synthesized by drug discovery research processes or obtained externally are regulated by applicable laws or regulations, such as for poisonous and toxic substances, radioactive materials, narcotic or psychotropic drugs, or stimulants, and shall then handle these substances as prescribed by such laws and regulations.
  • (3) When using genetic data or tissue from human subjects, we shall comply with all relevant laws, regulations and internal rules taking all possible measures to protect the privacy of individuals. In addition, in recombinant gene experiments, we shall comply with applicable laws and regulations and thoroughly manage safety so as to prevent the genetically modified organisms from impacting wildlife and such.
  • (4) We shall comply with the Infectious Diseases Act and the Livestock Infectious Diseases Prevention Act to prevent accidents with biohazards caused by disease agents.

6. Use of test animals

In our research and development of medical products and such, when we conduct experiments using animals, we shall be aware of precious sacrifices made for the sake of these experiments, and shall comply with applicable laws and regulations regarding the breeding, protection and management of the animals, from the perspective of science and animal welfare.
In addition, we shall strive to give utmost consideration to the 3 Rs – Replacement (use of alternative methods), Reduction (minimizing the number of animals use) and Refinement (alleviation of pain) - that are the fundamental philosophy of animal testing.

7. Development

  • (1) In conducting preclinical trials, we shall comply with our internal rules and applicable laws and regulations, including pharmaceutical laws, reliability standards and GLP, and shall obtain accurate data by which effectiveness, safety and quality can be judged properly and objectively from a scientific perspective.
    In addition, we shall give sufficient based on the data obtained in preclinical trials warrants conducting clinical trials on this drug.
  • (2) In conducting clinical trials, we shall comply with our internal rules and applicable laws and regulations, including pharmaceutical laws, reliability standards and GCP and other relevant laws and internal regulations, create objective and accurate data on effectiveness and safety, and never engage in falsification or concealment of such data. In addition, we shall not require any contractors or joint research institutions to commit such improper conduct.
  • (3) We shall give the utmost respect to the human rights when conducting clinical trials and appropriately convey necessary information to medical institutions. In the unlikely event it is determined that there is a safety issue, we shall immediately re-examine the protocol and make a proper determination as to whether or not to continue the clinical trial. In addition, we shall establish an internal system in the unlikely event of harm to the health of a test subject, and shall make the safety of test subjects the top priority in handling matters.
  • (4) In accordance with voluntary industry codes, we will appropriately disclose information on clinical trial information and the costs incurred in conducting clinical trials in order to improve transparency.

8. Approval applications

In applying for approval to manufacture and sell pharmaceutical products (including partial change approval applications and minor change notifications), we shall comply with applicable laws and regulations and internal procedures, the application documents shall be accurately prepared based on the results of investigations or tests conducted in compliance with related laws, regulations and internal rules. In addition, when the results of surveys that suspect the quality, efficacy, or safety of the pharmaceutical products submitted for the application are obtained, the results are reviewed and evaluated, and the results are recorded in the application materials, and any falsification, replacements, concealment, or other improper conduct is not undertaken. In the event such trials are conducted by group companies or external vendors, we shall adequately supervise the implementation of the trials and shall ensure that the implementation of the trials and the collection of data are carried out properly.

9. Supply Chain

  • (1) We shall be aware that our products are life-related products and shall ensure a stable supply of medical institutions and patients.
  • (2) In the manufacture of products, we shall comply with applicable laws and regulations, including pharmaceutical laws, GMP and GQP, and with our internal rules, and strive for safe operations that prevent accidents and accidents, as well as conducting appropriate manufacturing management and quality control throughout the entire manufacturing process (including at Group companies or contract manufacturers). In the unlikely event a problem arises with respect to the manufacturing and quality of products, we will take measures to respect human life and promptly investigate the root cause and prevent recurrence.
  • (3) We shall comply with all relevant laws, regulations and lawfully distribute, import and export products, raw materials, equipment, instruments, software and such.

10. Exchange with Healthcare Parties (Pharmaceutical Information Activities.)

  • (1) We shall engage in fair and transparent information activities through exchanges with healthcare professionals (medical information activities, etc.), complying with relevant laws and regulations, voluntary industry codes and our internal rules, we shall practice fair and transparent informational activities, without defaming or slandering other businesses or their products.
  • (2) We shall acquire the medical and pharmaceutical knowledge necessary for interaction with healthcare professionals, and will appropriately provide and collect information on pharmaceuticals, etc. in order to improve and improve the health of patients and the general public in accordance with relevant laws and regulations
  • (3) We shall comply with the rules established by the medical institutions we visit when exchanging with healthcare professionals.
  • (4) In relationships with medical personnel of national or public medical institutions etc., we shall maintain sound relationships that do not violate, and do not give rise to suspicion of violations of, criminal law bribery prohibition provisions, the national public service ethics act or other ethics-related laws and regulations.

11. Management of safety measures and investigations after manufacture and sales

  • (1) We shall comply with the conduct ]post-marketing safety control operations and post-marketing surveillance in compliance with the Pharmaceuticals and Medical Devices Law, GVPs, GPSP, and other related laws and regulations, as well as in-house regulations, In order to establish proper use methods for pharmaceutical products after manufacturing and sales, we shall comply with the Pharmaceuticals and Medical Devices Act, related laws and regulations such as GVP and GPSP, industry voluntary standards and internal regulations, etc. We shall also implement post-manufacturing and sales safety management tasks and post-manufacturing and sales investigations.
  • (2) In the event that we suspect that an adverse event has occurred due to our products, we promptly report it to the relevant authorities in accordance with relevant laws and internal regulations, and take safety measures as necessary.
  • (3) We shall comply with applicable laws and regulations, voluntary industry codes, and our internal rules to collect and create re-examination or re-examination evaluation materials, and shall implement investigations, trials and post marketing surveys for pharmaceutical products, etc.

12. Clinical Research

  • (1) In supporting clinical research, we shall comply with the Clinical Research Law, the Ethical Guidelines for Human Medical Research, the Fair Competition Code and other relevant laws, industry voluntary codes, and internal regulations. In doing so, we will fully examine the value of supporting clinical research based on data from research and development.
  • (2) We shall strive to improve the transparency of our operations by paying attention to conflicts of interest and disclosing information on funding in an appropriate manner in accordance with the Clinical Research Law and the industry's voluntary standards.

Ⅲ. Ensuring Proper Trade and Reliability of Financial Reporting

13. Relationship with Public Officials

  • (1) We shall not provide, offer or promise illegal benefits (such as money, goods, entertainment or benefits) to public officials, those deemed to be public officials or those designated by special laws. In addition, we shall firmly reject any request to provide such benefits.
  • (2) We shall not provide, offer or promise illegal benefits to foreign public officials or civil employees, in violation of foreign and domestic related laws and regulations and applicable laws such as Japan’s Unfair Competition Prevention Act. In addition, we shall firmly reject any request to provide such benefits.
  • (3) We shall not allow our agents, subcontractors, or others acting on our behalf to be involved in the acts described above.

14. Outsourcing to Healthcare Providers

When we retain outside experts, including physicians and pharmacology personnel, as consultants or advisors or such, we shall take care to not violate applicable laws and regulations and shall always execute a contract in writing. The consultant fees or advisor fees shall be in accordance with the internal rules of the organization to which the counterparty belongs, an amount appropriate to the services received by us, and a description of those services shall be recorded in writing.

15. Contributions to medical institutions and external societies

When we make contributions to medical institutions, Universities, external societies or such, we shall confirm that such donations are not illegal, and shall make the contribution as a true donation or subsidies, with no demand for anything in return and we do not use them as a means to induce transactions. In addition, in cases where the Federation of Pharmaceutical Manufacturers’ Association of Japan or such is making a contribution, we shall not make separate contributions.

16. Relationship with patient groups

  • (1) We shall maintain high ethical standards and respect the independence of patient groups in all forms of cooperation with patient groups. We shall also strive to deepen mutual understanding of objectives and content of collaboration with patient groups.
  • (2) We shall strive to ensure transparency and improve reliability of the financial and other support we provide to patient groups in order to gain a broad understanding of the contribution of these activities to the activities and development of patient groups.

17. Relations with government and public agencies

  • (1) We shall strive to build sound, fair and transparent relations with government and administrative agencies (including public facilities, public research organizations and public medical institutions), and shall not engage in any conduct giving rise to suspicions of corruption nor make any illegal donations.
  • (2) We shall respond with integrity to audits and inspections by administrative agencies and such.

18. Fair trade

  • (1) In our relations with medical institutions, competitors, customers, suppliers, vendors, etc., we shall conduct our fair trade, in accordance with the rules, such as anti-trust laws, the fair competition code, the pharmaceutical association code of practice, and sub-contracting laws.
  • (2) We shall not exchange information with competitors regarding product price, production volumes, customer selections or other competitive conditions, nor shall we reach any agreements that would affect these competitive conditions.

19. Management of Conflicts of Interest

  • (1) We shall not act contrary to the interests of the company, nor shall we perform transactions for the sake of personal gain of its officers and employees, at the expense of the company.
  • (2) We shall maintain fair and sound relationships with suppliers, suppliers, etc., and will not accept, demand, or promise to receive illegal profits (money, goods, entertainment, benefits, etc.) by taking advantage of our position and authority.

20. Prohibition of illegal benefits to shareholders

We shall comply with regulations set forth in the Companies Act that prohibit payoffs to shareholders.

21. Regarding the reliability of financial reporting

  • (1) We shall comply with laws and regulations and internal rules and such in our corporate accounting. In addition, we shall accurately prepare accounting records in accordance with accounting principles and practices.
  • (2) We shall not engage in fraudulent accounting, window dressing, or other acts of account settlement. We will comply with domestic and foreign tax laws and pay taxes in an appropriate manner.

Ⅳ. Personnel and Labor

22. Worker-friendly Work Environment

  • (1) We shall comply with laws and regulations related to health and safety, from the Industrial Safety and Health Act. In addition, the company shall create a workplace environment that is easy to work in and takes health and safety into consideration, and shall strive to prevent work-related accidents and maintain both the physical and mental health of employees.
  • (2) We shall promote work-life balance and support employees so that they can work and live while maximizing their abilities and experience.

23. Prohibition of Discrimination and Harassment

  • (1) Both within and outside the company, we shall not engage in any including employment, treatment or promotion due to race or harassment on the basis of race, nationality, ethnicity, gender, age, religion, beliefs, ideas, sexual orientation and self-perception, educational background, disability, illness, social status or such.
  • (2) We shall not engage in any harassment, such as sexual harassment and power harassment. In addition, we shall prevent and eliminate harassment in the workplace, and maintain a comfortable workplace environment.

24. Fair Human Resources

  • (1) We shall comply with the Labor Standards Law and the Employment-Related Law, as well as internal regulations, and we will promote the appropriate placement and exchange of personnel.
  • (2) We shall strive to provide employees with opportunities to realize their potential and achieve self-fulfillment. We shall evaluate work achievements fairly, according to evaluation criteria clarified in advance, and shall properly promote transparent and convincing personnel evaluations.
  • (3) In employment, evaluations, transfers, promotions and salary increases, we shall not accord special treatment to any individual due to a personal relationship with oneself or an officer or employee.

25. Enriched training and education

We shall implement training and education regarding compliance on an ongoing basis. In addition, we shall actively and fairly provide employees with training and education opportunities in order to foster professional human resources.

26. Guarantee of civil rights

We guarantee the freedom to exercise civil rights.

27. Safe driving

We shall always attempt to drive safely and in particular, shall not drive when intoxicated, nor allow others to do so.

Ⅴ. Management of Assets and Information

28. Prohibition of Private Use of Corporate Assets

  • (1) We shall use company funds, goods and other assets solely for the purpose of carrying out our assigned duties, and shall not use them for illegal purposes, such as illegal entertainment or bribery, or use them for personal gain or the benefit of a third party. We shall not use our rank or authority to improperly claim expenses or embezzle money or goods.
  • (2) We do not use the company's personal computers or other information systems for purposes other than business activities. In addition, we will not install software, etc. that is not permitted in business on the company's personal computers and other information systems without the approval, or connect it to an external network, etc.

29. Handling of intellectual property

  • (1) We shall recognize that the fruits of research, development and other work (including inventions, devices, ideas, patent rights, utility model rights, trademarks, designs, copyrights, know-how and technical information) are important assets (intellectual property) of the company, and shall actively work to obtain rights for these fruits. In addition, we will develop the Rules for Employee Inventions, encourage employees to invent, and effectively utilize the Company's intellectual property for the performance of their duties.
  • (2) We shall respect the intellectual property rights of third parties and comply with related laws and regulations. In addition, we shall not, in the course of carrying out our work, wrongly infringe intellectual property rights held by third parties.

30. Handling of Confidential Information

  • (1) We shall recognize the importance of the information assets possessed by the company, and shall appropriately manage the information, from the perspective of information confidentiality, completeness and availability, in accordance with our internal rules such as our Information Security Policy.
  • (2) When an information asset is confidential information, whether during our employment or after retirement, we shall not disclose the information outside the company without first following proper procedures, and shall not improperly use the information for personal gain or the benefit of any third party. Within the company, we shall not disclose the information to persons needing the information in the course of their work without first following proper procedures.
  • (3) We shall not improperly obtain, use or disclose the confidential information of any third party, either directly or indirectly. In addition, the Company will not illegally use or disclose confidential information of third parties obtained through employment or on loan for the Company.
  • (4) In regards to confidential information disclosed to us, we shall keep the information separate from our own company’s information and shall strictly control the information in the same manner as for our own confidential information.
  • (5) We shall appropriately control information assets stored as electronic information in the same manner as written information assets.

31. Handling of personal information

  • (1) We shall recognize the importance of protecting personal information and privacy, shall lawfully and properly obtain and handle personal information in accordance with applicable laws and regulations and our internal rules, and shall not disclose an individual’s information to those outside the company without the consent of that individual. Even within the company, we shall not disclose the information to anyone other than persons needing the information in the course of their work.
  • (2) We shall appropriately construct and operate personal information management systems in order to prevent loss, leakage and improper access of personal information held by the company.

32. Compliance with insider trading regulations

We shall comply with insider trading regulations set forth in the Financial Instruments and Exchange Act and other insider trading regulations stipulated in overseas laws and regulations. If in the course of our duties, such as in a contract with a business partner that issues listed securities, we learn of material facts relating to that company, we shall not trade those securities either on our own account or on behalf of the company until after such facts are publicly disclosed through due procedures. In addition, we shall not communicate information or recommend transactions to third parties with respect to such material facts.

33. Corporate Communication Activities

  • (1) When providing information via our website or conducting digital communication using social media, we comply with relevant laws and regulations, industry voluntary codes, and internal regulations, etc., in order not to advertise ethical drugs to people other than healthcare parties. In addition, when we plan and support digital communication using social media, etc., we will be responsible for confirming whether or not there is inappropriate information such as use of our own pharmaceuticals, etc. outside the approval, or slander of other companies' products, etc., in relation to the posting by a third party.
  • (2) We shall be aware that transmitting information on social media can reflect on the company’s image and can be troublesome to the company and third parties, and shall always be conscious of responsibility for our words and actions. We shall not say or do anything to harm the reputation or credibility of people inside or outside the company.

34. Management of contracts and documents

  • (1) When executing contracts (including memorandums of understanding, written agreements, and letters of confirmation) with a business partner or such, we shall discuss the matter with relevant departments, and then fairly and appropriately study and negotiate the matter from the perspective of compliance with relevant laws and regulations, the interests of our company and reasonableness. Affixing the company seal to contracts and such shall be done after following the proper procedures, in accordance with our internal rules.
  • (2) We shall comply with applicable laws and regulations and with internal rules to appropriately create, handle, store, save and destroy all business documents, printed matter and all other records (including electronic documents) such as contracts, minutes, written requests for managerial decision, correspondence, reports and vouchers.

Ⅵ. Good Corporate Citizenship

35. Compliance with human rights, treaties and overseas laws and regulations

  • (1) We shall understand and respect human rights, the diverse values, personalities, and personalities of each other, and will not discriminate or harass people on the basis of race, nationality, ethnicity, beliefs, sex, social status, physical disability, appearance, etc. We shall also express our respect for human rights in the supply chain and seek their understanding.
  • (2) In our international business activities, we shall not only comply with international conventions and other international norms and local laws and regulations, but also respect local cultures and customs. We will also ask Group companies and affiliated companies in Japan and overseas to do the same.

36. Environmental preservation

We shall comply with environmental laws and regulations and our internal rules, and as a life-related company, shall conduct our business activities while always considering the impact on the earth’s environment and local societies and to the preservation of the biodiversity. In addition, we shall actively work to preserve the environment, stressing environmental impact, such as global warming, ozone layer destruction and acid rain. In other words, we shall promote energy savings, resource savings, reduction of industrial waste, recycling activities and environmentally-friendly product production in all our activities from research and development to production and sales.

37. Disaster prevention efforts

We shall think safety first and try to prevent accidents and fire disasters. We shall strive to build a system for business continuity in preparation for emergencies such as natural disasters and fires.

38. Prohibition of illegal drug use and gambling

We shall be conscious of take care in regards to legal compliance in all aspects of our workplace and other work activities, and shall not engage in illegal drug use or gambling (including so-called "friendly wagers" or other casual betting).

39. Response to anti-social forces and groups

We shall not have any relationships, firmly reject and adamantly oppose demands for money or other benefits by means of false claims masquerading as product claims, blackmail, extortion, or harassment by anti-social forces or groups that threaten the order and safety of civil society, such as crime syndicates.