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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. Relationships with stakeholders

  • (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 out our business activities, we shall strive to act in harmony with local residents and local societies, and to contribute to the development of society.

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, the Maruho Code of Compliance Standards and internal rules.

4. Dealing with violations

  • (1) If a violation is discovered or suspected of any relevant Maruho Code of Compliance Standards or other related applicable law, we shall notify the head of the department, other management, internal/external compliance hotlines, etc.
  • (2) We shall promptly investigate violations or suspected violations of which they are notified, and shall, as needed, take appropriate corrective action which may include some form of penalty.
  • (3) We shall forbid any retaliatory action against any employee who raises a concern in good faith.

Ⅱ. Business Activities

5. 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) We shall demonstrate the utmost respect for human rights and the dignity of life when conducting genome drug discovery research such as human gene research. 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.

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 consideration to whether 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. In addition, in order to try to speedily bring safe and effective products to market, we shall implement clinical trials in conjunction with physicians and experts, create reports (materials) accurately reflecting the data obtained, and give sufficient consideration to safety and effectiveness.
  • (3) We shall give the utmost respect to the human rights of the subjects participating in 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 cases where we ask a medical institution to conduct a clinical trial, we shall execute a contract in writing, shall be clear as to the payment of expenses to the medical institution, and shall not make any payments of grant contributions or manuscript fees etc. which are different from actual service(s) performed. Also, contracts with national or public medical institutions, etc. shall comply with the “Implementation Guidelines for Joint Research by Industry and Universities”.
  • (5) 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.

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, shall use as application materials only materials that accurately record facts and data based on trials conducted with the assurance of scientific quality and reliability of results, and shall never engage in improper conduct such as the use of data based on trials that deviate from internal procedures or applicable laws and regulations or the falsification, replacement or concealment of data. 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. Manufacture and import/export

  • (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 shall adequately control quality across all manufacturing processes, including processes as group companies and external manufacturing sub-contractors. In the unlikely event a question arises as to the effectiveness, safety or quality of products, we shall respond promptly, by issuing recalls or such, with respect for human life being the top priority, and we shall strive to discover the cause in order to prevent recurrence.
  • (3) We shall properly and lawfully distribute, import and export products, raw materials, equipment, instruments, software and such.

10. Pharmaceutical informational activities

  • (1) In our pharmaceutical informational activities directed at medical institutions, we shall comply with pharmaceutical laws, the fair competition code for the manufacture and sales of prescription drugs, the medical equipment industry fair competition code, the Japan Pharmaceutical Manufacturers Association’s Promotion Code for Prescription Drugs and our internal rules, and 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 pharmaceutical informational activities, and shall properly collect and provide information regarding pharmaceutical products in order to improve and elevate the health of patients and the general population, in accordance with applicable laws and regulations such as pharmaceutical laws.
  • (3) In our pharmaceutical informational activities, we shall comply with rules established by the medical institutions we visit.
  • (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. Sales, marketing and advertising activities

  • (1) In our sales, marketing and information distribution activities, we shall comply with applicable laws and regulations and shall practice fair business operations in accordance with corporate ethics.
  • (2) We shall comply with applicable laws such as pharmaceutical laws and with our internal rules in the creation and use of publicity and advertising materials. In addition, our basic policy shall be fair content and expression so as to avoid lies, exaggerations, social discrimination and human rights infringements.

12. Safety measures and investigations after manufacture and sales

  • (1) In regards to our products, we shall comply with applicable laws and regulations and our internal rules, and shall put effort into safety measures such as collecting and studying information of proper use and implementation of measures to ensure safety.
  • (2) We shall comply with the various ministerial ordinance and our internal protocols in order to establish proper use methods for pharmaceutical products after manufacturing and sales, and shall implement post-manufacturing and sales safety management tasks and post-manufacturing and sales investigations.
  • (3) We shall comply with applicable laws and regulations and our internal rules to collect and create re-examination or re-examination evaluation materials, and shall implement investigations or trials.

Ⅲ. Ensuring Proper Trade and Reliability of Financial Reporting

13. Prohibition against entertaining 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 or others acting on our behalf to be involved in the acts described above.

14. Use of consultants

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 an amount appropriate to the services received by us, and a description of those services shall be recorded in writing.
In addition, if an organization to which the retained party belongs has any internal rules regarding consultants and advisors, we shall comply with those rules.

15. Contributions to medical institutions and academic societies

When we make contributions to medical institutions or academic societies or such, we shall confirm that such donations are not illegal, and shall make the contribution as a true donation, with no demand for anything in return. In addition, in cases where the Federation of Pharmaceutical Manufacturers’ Association of Japan or the Osaka Pharmaceutical Manufacturers Association or such is making a contribution, we shall give priority to contributions by that route, and shall not make separate contributions.

16. 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.

17. Fair trade

  • (1) In our relations with medical institutions, competitors, customers, suppliers, vendors, etc., we shall conduct our business activities fairly and legally, in accordance with the rules, such as anti-trust laws, the fair competition code for the manufacture and sales of prescription drugs, the Japan Pharmaceutical Manufacturers Association’s Promotion Code for Prescription Drugs and sub-contracting laws.
  • (2) We shall have fair and sound relationships with our suppliers, vendors, etc. and shall not use our job rank or authority to receive, demand or promise improper benefits (money, goods, entertainment or any other benefits).
  • (3) 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.

18. Prohibition of conflicts with personal interests

We shall not act contrary to the interests of the company, nor shall we perform transactions for the sake of personal gain, at the expense of the company.

19. Prohibition of illegal benefits to shareholders

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

20. Accuracy of accounting records and compliance with tax laws

  • (1) We shall comply with accounting-related 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 always be conscious of and comply with foreign and domestic tax laws in our business activities.

Ⅳ. Personnel and Labor

21. Labor law compliance and efforts on behalf of safety and health

  • (1) We shall comply with employment-related laws and regulations, such as the Labor Standards Act.
  • (2) 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.
  • (3) We shall understand the gist of the Health Promotion Act, and shall promote measures to prevent passive smoking.

22. Prohibition of unfair discrimination, sexual harassment and power harassment

  • (1) Both within and outside the company, we shall not engage in any unfair discrimination or other discriminatory handling or harassment on the basis of race, nationality, ethnicity, gender, age, religion, beliefs, ideas, sexual orientation, 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 such as sexual harassment and power harassment, and maintain a comfortable workplace environment.

23. Implementation of fair personnel evaluations

  • (1) 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.
  • (2) 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.

24. 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.

25. Promotion of work-life balance

We shall support employees so as to enable them to make the best use of their abilities and experience while balancing their “work” and “life”.

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.

28. Prohibition of deceptive contracting

We shall not act to disguise the use of dispatched workers as sub-contracting, commissioning of work or secondment (deceptive contracting, deceptive secondment).

Ⅴ. Management of Assets and Information

29. Prohibition of personal use and provision for illegal purposes of company funds and assets

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.

30. 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. The company’s intellectual property should, of course, be utilized effectively to carry out our work, shall be handled with care and shall not be improperly used for personal gain or the benefit of a third party.
  • (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.

31. Handling of information assets

  • (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.
  • (4) In regards to confidential information disclosed to us by others under a confidentiality agreement, 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.
  • (6) We shall not use company computers or other information systems for any purpose other than business activities. We shall not install software, etc. not authorized for work on company computers or other information systems nor connect to networks, etc. outside the company without permission.

32. 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.

33. Compliance with insider trading regulations

We shall comply with insider trading regulations set forth in the Financial Instruments and Exchange Act. 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, nor shall we disclose such material facts to any third party.

34. Proper use of social media

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.

35. 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

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

In our international business activities, we shall respect human rights such as race, nationality, ethnicity and gender. We shall comply with international rules such as treaties and with local related laws and regulations, and shall respect local culture and customs.

37. 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 giving consideration to 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.

38. 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.

39. 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).

40. Response to anti-social forces and groups

We shall 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. In addition, we shall strive to eliminate all relations, including ordinary business transactions, with such groups.

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