NIPRO Code of Practice
NIPRO Compliance Action Guidelines

1Introduction

Revision of the NIPRO Compliance Action Guidelines
Since our founding in 1954, under the Corporate
Creed of “Willingness” and the concept of medical
technology and creative innovation, we have been
sincerely conducting businessactivities in order.
to contribute to society and improve people’s healthand well-being by stably providing products andservices to people who need them around the world.
Currently, the NIPRO Group conducts a wide
range of life and health-related business activities,
mainly the manufacture and sale of medical
devices, pharmaceuticals, and regenerative medical
products. In steering the management of theentire Group,
I believe it is my responsibility to gain and maintainthe trust of patients, healthcare professionals,
other medical personnel, research institutes,
business partners, and all other stakeholders.

In recent years, the global business environmenthas been undergoing significant change.
For example, in Japan, the Ministry of Health,Labour and Welfare has revised the Pharmaceuticals
and Medical Devices Act to require companies
in the medical industries to establish a legal
compliance system. In April 2019, the Ministry
also established and began applying the Guidelines
for Providing Information on Prescription Drugs
in Sales Activities in order to enhance people’s
health and hygiene. These rules strongly request
medical product companies to establish andappropriately operate an internal self-inspection
and management system to prevent the inappropriate provision of information in sales activities.
In response, trade associations in the medical
industries have drastically revised their action

Management Philosophy
In looking toward our future as a truly global comprehensive
medical manufacturer,
we believe our current and future responsibility to society is todevelop innovative,
value-added products and technologies that improve patient
outcomes and healthcare worldwide.

1

guidelines to discipline the behaviors, attitudes,
and morals of people engaged in life and medical
business activities.
An attitude that emphasizes measuring the successof a business just by financial results needs to be
severely questioned. Companies with low awareness of corporate social responsibility are putting
their existence at risk. In the first place, each andevery member of a company needs to have astrong awareness of their role as a member ofsociety and comply with laws and regulations
and corporate ethics.
Under this social environment, we revised the
NIPRO Compliance Action Guidelines and the
NIPRO Code of Product Promotion to ensure ourcompliance with laws, regulations, and corporate

ethics. Priority must be placed on acting correctly
as a member of society, perceiving the truth,
distinguishing right from wrong, keeping to ourbeliefs. Each of us, including myself, employees,
and officers, must follow these Action Guidelines.
We strictly adhere to these Action Guidelines inour daily operations and keep to the policy toquickly and accurately meet the expectations andtrust of people worldwide who need our medical
expertise and technology. I believe that these efforts
will bring us dramatic growth and development
and make us a truly global company that
contributes to society.

Yoshihiko Sano

NIPRO Corporation President

2

NIPRO Code of Practice
Relevant Department ALL S Sales M Manufacturing

R R&D

L Logistics

A Administration

NIPRO Compliance Action Guidelines Table of Contents

Ⅰ. Essential Responsibilities as a Life-Related Business Company

5

Ⅱ. Responsibilities of Top Management

6

Ⅲ. Principles of Corporate Activities

7

1. Compliance with laws, regulations, and corporate ethics

ALL

7

Creation and provision of excellent products and services and ensuring their safety

8Compliance with laws and ethics in other countries and respect for local culture and customs

9S

2. Actions towards people having an interest in the Company

A

10

Customers

10

Shareholders

10

Social engagement and contribution to social development

11

Disclosure through the mass media

12
ALL 13

3. Sound and fair relationships
Sound and fair relationships with politicians and government officials

13

Proper relationships with patient groups

14

Refusal of favors to antisocial forces and organizations

14

Compliance with the regulations on insider trading andthe regulations on trading of treasury shares by officers

15R

4. Testing, research, and development of products

A

16

Testing, research, and development

16

Care and use of laboratory animals

18

Conducting clinical trials

18S

5. Manufacturing and sales activities

19
19

Provision of products

6. Post-marketing safety measures and surveillance

S

A

20

Post-marketing safety measures

20

Application for approval

21

7. Clinical research
8. Manufacture, import, and export of products

M

R

A

21

L

A

22

Manufacturing

22

Import23

Export24

9. Stable product supply
10. Intellectual property rights

3

7Compliance with laws and regulations and corporate ethics applicable to businesses

M

L

A

24

R

A

26

11. Environmental conservation

ALL

26

12. Product information activities

S

28

S

A

29

R

A

31

15. Engagement with public officials

S

R

32

16. Outsourcing to healthcare professionals

S

R

33

17. Donations

S

R

34

13. Sales, publicity, and advertising
14. Fair and proper transactions

S

18. Avoidance of conflicts of interest and separation of private matters from business ALL 34
19. Accuracy of accounting records

A36

20. Proper use of company assets

ALL

36

A

37

ALL

38

21. Compliance with tax laws
22. Network systems and information management

23. Handling of confidential information and respect for third party confidential information ALL 39
24. Handling of personal information
25. Working environment

A

40

ALL

41

Conclusion and fulfillment of proper contracts and promotion of health andsafety in the workplace41

No favoritism

43

Support for people with physical, mental, or intellectual difficulties

43

Objective and fair evaluations and a comfortable working environment

44

No inappropriate speech or behavior

45

26. Respect for human rights and fair and equitable treatment

ALL

46

No discriminatory treatment

46

Respect for and securing children’ s rights

47

No improper recruitment activities

49

27. Self-restraint and prohibition of improper acts in private life

ALL

49

No use of illegal drugs

49

No drunk driving

50
51

No criminal acts, misdemeanors, or violation of ordinances, laws, or regulations

28. Handling of whistleblowing and grievances

ALL

51

29. Criteria for compliance with the Articles of Incorporation,internal regulations, and external charters and guidelines

ALL

52

Compliance with the Articles of Incorporation, internal regulations, and other rules

52

Criteria for complying with external charters and guidelines

53

30. Compliance with international rules and local laws andregulations and contribution to local communities

ALL

53

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NIPRO Compliance Action Guidelines

With NIPRO’s corporate mission in mind, we haveestablished and sincerely comply with the following
Action Guidelines for our engagement with customers,
employees, business partners, shareholders, industries,
government officials, local communities, and thegeneral public.

Ⅰ Essential Responsibilities as a Life-Related Business Company－The Company and its group companies conduct business activities as life-related
business companies under the public health insurance programs. Given thisbackground, we reaffirm our essential responsibilities to comply with thefollowing philosophies:[Philosophies]○ In conducting business activities, we make it our top priority to contribute topeople’s health and life and act with a high sense of ethics, including bioethics, notto mention compliance with laws and regulations.
○ NIPRO has established internal transparency guidelines based on the Transparency
Guidelines for the Relationship Between Corporate Activities and Medical

5Institutions “Transparency(
Guidelines”) published by the Japan Pharmaceutical
Manufacturers Association. In conducting business activities, we follow theseinternal guidelines to ensure the transparency of our engagement and appropriately
fulﬁll our accountability to society.
○ To contribute to the advancement of medicine and pharmacy and the developmentof life science, and promote appropriate industry-academia collaboration, we build
relationships of trust with researchers, healthcare professionals, and patient groups.
We also fulﬁll our corporate social responsibilities, recognizing that our existence as
a company builds on contributing to environmental protection, sustainable developmentof local communities, improvement of people’s lives, and other social issues.

[Reference Laws and Regulations]Japan Business Federation Charter of Corporate Behavior; Code of Ethics;
Compliance Program; and others

Ⅱ Responsibilities of Top Management－The top management of the Company and each group company executes thefollowing duties:○ It is the role of the top management to fulﬁll the Essential Responsibilities of a
Life-Related Company stated above. Recognizing this, the top management, whichis responsible for the acts of all oﬃcers and employees, takes the lead in practicing
these Guidelines and thoroughly disseminates them to related parties, and develops
an internal system.
○ If any situation that violates the spirit of these Guidelines occurs, the top management
will take responsibility for resolving the issue, investigate the cause, and prevent a
recurrence.
○ We respect the spirit of these Guidelines when conducting business activities at all
business divisions and subsidiaries in Japan and overseas.
○ We announce the basic principles of these Guidelines to business partners andallied companies and ask for their understanding.

6

NIPRO Compliance Action Guidelines

Ⅲ Principles of Corporate Activities－We faithfully conduct our business in compliance with laws, regulations, andrules applicable to our research, development, manufacturing, sales, management,
and other business activities. If an emergency occurs, such as a large-scale disasteror the spread of a new type of infectious disease, we will take flexible, appropriate
measures and responses, putting the priority on human life.

1. Compliance with laws, regulations, and corporate ethics Compliance with laws,
regulations, and corporate ethics－With our corporate mission in mind, we strive to achieve the SDGs and comply
with the guidelines established by trade organizations, laws, regulations,industrial policies, ethical standards enforced in Japan and overseas, and ourinternal regulations and rules in all of our business activities.

Compliance with laws and regulations and corporate ethics applicable tobusinesses
1. Life-related companies like ours, which handle products directly connected topeople’s lives and health, are strictly regulated by laws and regulations,
including the Pharmaceuticals and Medical Devices Act. We strongly recognize
the reason for our existence as a Public Organ of Society that should meet the
expectations and trust of society when conducting business.
2. In conducting business activities, we respect the spirit of the Constitution,comply with general laws and regulations such as the Civil Code, theCompanies Act, and the Penal Code, business-speciﬁc laws and regulations,general internal regulations (hereinafter referred to collectively as“laws andregulations”), and corporate ethics. We discipline ourselves with a high aim andsense of ethics to serve society with a high level of ethics and transparency.

7

3. We act responsibly, recognizing that violations of laws and regulations andcorporate ethics may result in punishment.

[Reference Laws and Regulations]
Constitution; Civil Code; Companies Act; Penal Code; Pharmaceuticals and Medical
Devices Act; Antimonopoly Act; and others－We contribute to people’s health and the future of medicine.
Creation and provision of excellent products and services and ensuring theirsafety1. We contribute to people’s health and the future of medicine by creating great
products and providing eﬀective and safe products and services.
2. If it is found that any product or service we supply causes damage or danger
to people’s health or the environment, we will act promptly and appropriately
to investigate the cause and prevent the spread of the damage and a recurrence.
We will also faithfully disclose correct and precise information regarding suchan incident widely to the public.

[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; Basic Act on Consumer Protection;
Consumer Contract Act; Product Liability Act (PL); and others

8

NIPRO Compliance Action Guidelines－When we do business overseas, we use sound judgment in compliance with local
laws and regulations and local ethical values.

Compliance with laws and ethics in other countries and respect for local
culture and customs
1. With the rapid progress of globalization and a borderless world, Japanesecompanies are operating across borders. In our overseas business activities,
we comply with local laws, regulations, and ethical values and respect local
culture and customs with a view of the international community.
2, If no compliance Code has been established by any trade organization in acountry, we will comply with the compliance Code established by theInternational Federation of Pharmaceutical Manufacturers & Associations(IFPMA).
3. If practicing any part of these Guidelines is contrary to any local law or ethicalvalue of a country, we will have consultations between the person in charge ofcompliance and corporate ethics of the local group company, lawyers, andother professionals to determine the right action based on sound judgment.

9

2. Actions towards people having an interest in the Company－We create and do business from the customer’s point of view.
Customers
For a company to be accepted into the market, it must gain the trust of consumers,
users, business partners, distributors, contractors, and other customers (hereinaftercollectively referred to as“customers”).
We always engage with our customers with faith and fairness and provide
products and services that satisfy their proper requests.

[Reference Laws and Regulations]
Basic Act on Consumer Protection; and Consumer Contract Act－We disclose our corporate information to shareholders and investors in a timely,
appropriate and fair manner, promote their understanding of our corporate activities,
and strive to gain trust as a company open to stakeholders and the public.
Shareholders
1. We manage the Company by properly understanding and fulﬁlling thefunctions and duties of general meetings of shareholders, the Board of
Directors, directors and audit & supervisory board members, and otherinternal organs stipulated by law.
2. We establish internal control systems to ensure the appropriateness of ourbusiness operations.
3. We place importance on public relations activities for shareholders and10事業継続計画（BCP）
NIPRO Compliance Action Guidelines

investors, disclose meaningful and reliable information in a timely manner, andstrive for full accountability to gain stakeholders’understanding of ourmanagement and business activities.

[Reference Laws and Regulations]Companies Act (Relationship between directors and the Company, Duty of care of agood manager, Duty of loyalty of directors, Responsibility of directors to the Company,
Shareholders’representative action, Responsibility of audit & supervisory board
members to the Company); Financial Instruments and Exchange Act (Prohibition of
insider transactions by interested persons within the company); and others[Reference External Standards]
Rules of Financial Instruments Exchanges (Timely disclosure)[Reference Internal Regulations]
Articles of Incorporation; and Board of Directors Regulations－We conduct business activities with an awareness of our responsibility as amember of the local community.
Social engagement and contribution to social development
1. The relationship with the community in which we do business and where our
employees and customers live is essential for our existence as an enterprise.
2. We actively communicate with local communities, respecting local culture,religion, and tradition, and cooperate with a wide range of stakeholders,11including NPOs, NGOs, local communities, and governments.
3. We support our employees’volunteer activities.

[Reference Laws and Regulations]
Labor Standards Act; and others[Reference External Standards]
United Nations Volunteers Programme (UN); Universal Declaration on Volunteering(International Association for Volunteer Eﬀort [IAVE]); JPMA Code of Practice (Japan
Pharmaceutical Manufacturers Association); and others－We always disclose information in an appropriate and timely manner.
Disclosure through the mass media
We disclose information on our management policies, business activities,
products, and other information in an appropriate and timely manner, and strive
to gain the trust of people both in Japan and overseas as a transparent company
open to the stakeholders and the public.
We do not spread false or uncertain information for the purpose of manipulating
the market price.

12

事業継続計画（BCP）
NIPRO Compliance Action Guidelines[Reference Laws and Regulations]
Constitution (Freedom of expression, freedom of the press); Financial Instruments
and Exchange Act (Prohibition of the spreading of rumors and the use of fraudulentmeans, and disclosure); Order for Enforcement of the Financial Instruments andExchange Act (Public announcement measures); and others[Reference External Standards]
Rules of Financial Instruments Exchanges (Timely disclosure)

3. Sound and fair relationships－We maintain sound, open, and fair relationships with politicians and government
officials.
Sound and fair relationships with politicians and government officials
We ensure the fairness of any payment to political parties, political organizations,or any other similar groups, regardless of the title of the payment. We maintainsound and fair relationships with politicians and government oﬃcials (including
public facilities, public educational and research institutes) and refrain from any
act that may be suspected as corruption, including illegal political donations or
improper provision of favors.

[Reference Laws and Regulations]
Penal Code (Giving and receiving bribes, passing of bribes to a third party, andinﬂuence peddling); National Public Service Act; Local Public Service Act; PublicOﬃces Election Act; Political Funds Control Act; National Public Service Ethics Act;
National Public Service Ethics Code; Unfair Competition Prevention Act (Foreign
public servants); Act on Punishment of Public Oﬃcials’Proﬁting by Exerting Inﬂuence;and others

13[Reference External Standards]
Code of ethics of local public organizations and facilities; and U.S. FCPA

[Reference Internal Regulations]
NIPRO Bribery Prevention Guidelines; and Guidelines for Engagement withgovernment oﬃcials in Japan－We maintain transparent and proper relationships with patient groups.
Proper relationships with patient groups
With a high sense of ethics, we respect the independence of patient groups.
When we provide ﬁnancial support to patient groups, to gain a broad understandingthat our activities contribute to the activities and development of the patientgroups, we clarify our involvement and agree in writing on the purpose and content
of the support, and ensure transparency by keeping records. For this reason,
when we provide ﬁnancial support to a patient group, we will formulate andcomply with our own rules.

[Reference External Standards]
Code of Practice; and others－We are never involved with antisocial forces or organizations that pose a threat
to the order and safety of society.
Refusal of favors to antisocial forces and organizations
1. Just one compromise with or use of an antisocial force or organization may
result in the loss of the Company’s reputation and credibility. We refuse any

14事業継続計画（BCP）
NIPRO Compliance Action Guidelines

engagement with these organizations, including business relationships.
2. We systematically respond to and ﬁrmly refuse unreasonable demands fromantisocial forces.
3. We strictly comply with the provisions of the Companies Act prohibiting theprovision of beneﬁts to shareholders, and we ﬁrmly refuse relationships withcorporate racketeers.

[Reference Laws and Regulations]Companies Act (Prohibition of provision of beneﬁts to shareholders, A crime ofbribery to corporate racketeers); Act on Punishment of Physical Violence and Others;
Act on Prevention of Unjust Acts by Organized Crime Group Members; Ordinances
for the Elimination of Organized Crime Groups; and others[Reference External Standards]
Guidelines for Preventing Victimization by Antisocial Forces; Initiatives to Eliminate
Antisocial Forces; and others－We comply with the regulations on insider trading and the regulations on tradingof treasury shares.
Compliance with the regulations on insider trading and the regulations on
trading of treasury shares by officers
1. If any person inside the Company obtains important undisclosed information
related to the business of the Company, subsidiaries, or business partners,
he/she shall refrain from trading these securities by himself/herself or as theCompany until the information is made public through prescribed procedures.
2. Trading treasury shares by company oﬃcers is regulated by law.

15

[Reference Laws and Regulations]
Financial Instruments and Exchange Act (Obligation to report trading by oﬃcers,
Return of gains from short-term trading by oﬃcers, Prohibition of short-selling ofcompany stocks, Prohibition of insider trading by company insiders); and others[Reference Internal Regulations]
Insider Trading Regulations

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4. Testing, research, and development of products－We comply with bioethics, laws and regulations, and corporate ethics when
researching and developing products.
Testing, research, and development
To contribute to people’s health, welfare and medicine, we research and develop
high-quality and low-cost products while taking into account the safety andconvenience of healthcare professionals.
We always strive for creative innovation and technological improvement andobserve the following matters in research and development to realize high-quality
medicine.
1. In research and development, we comply with laws and regulations related totesting, research, and development, and corporate ethics, including bioethics.
We also carefully consider environmental conservation and the safety ofpeople engaged in research and development activities, and people in theneighborhood.
2. In conducting quality tests and the like at the product development stage, we

16

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

work together with healthcare professionals to ensure safety and scientiﬁcfairness. We also create, record, and store reproducible and accurate data incompliance with laws and regulations, including the Pharmaceuticals andMedical Devices Act and the Standards of Reliability of Application Data.
3. We properly use and store compounds and dangerous and harmful substances
handled in research and development activities, always conﬁrming whether
they are poisonous, harmful substances, narcotics or psychotropic drugs,
stimulants, or other substances regulated by law.
4. Research and development costs incurred for testing and research, andacademic research subsidies are subject to disclosure in accordance with theTransparency Guidelines. We appropriately fulﬁll our accountability for thesecosts.

[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; Ministerial Ordinance on Standards for
Conducting Nonclinical Trials on the Safety of Medical Devices and Pharmaceuticals(Good Laboratory Practice, GLP); Ministerial Ordinance on Standards for Conducting
Clinical Trials of Medical Devices and Pharmaceuticals (Good Clinical Practice, GCP);
Ministerial Ordinance on Post-marketing Safety Management Standards for Medical
Devices and Pharmaceuticals (Good Vigilance Practice, GVP); Ministerial Ordinanceon Standards for Post-marketing Studies and Testing of Medical Devices andPharmaceuticals (Good Post-marketing Study Practice, GPSP); Transparency
Guidelines; and others

17

－We treat laboratory animals with care and keep them responsibly.
Care and use of laboratory animals
1. We take care of laboratory animals with gratitude. When using them for testing
and research, we give due consideration to the dignity of animal life.
2. We keep laboratory animals responsibly and take measures to prevent theirinvasion or pollution of the human living environment.
3. We establish research and development systems that ensure the voluntaryand proper management of laboratory animals used for development from theviewpoint of animal welfare.

[Reference Laws and Regulations]
Act on Welfare and Management of Animals; and others[Reference external standards]
Standards for the Care and Management of Laboratory Animals－When conducting clinical trials, we respect the human rights of the subjects.
When outsourcing the clinical trial to a third party, we conclude a written
contract with the third party.
Conducting clinical trials
1. When conducting clinical trials, we comply with all applicable laws, regulations,and guidelines, including the Pharmaceuticals and Medical Devices Act, theMinisterial Ordinance on the Standards for Conducting Clinical Trials; Clinical
Trials Act; and Ethical Guidelines for Life Science and Medical Research
Involving Human Subjects.

18

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

2. When conducting clinical trials, we respect subjects’human rights to thefullest from an ethical point of view.
3. When we outsource clinical trials to a medical institution, we conclude a written
contract. We do not pay any improper compensation or any other beneﬁt that
may appear like bribery violating the bribery provisions of the Penal Code or
the Fair Competition Rules.

[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; GCP Ministerial Ordinance; Clinical Trials
Act; and others[Reference External Standards]
Ethical Guidelines for Life Science and Medical Research Involving Human Subjects;
and“Guidelines for Compensation for Health Hazards of Subjects”published by theJapan Pharmaceutical Industry Legal Aﬀairs Association[Reference Internal Standards]
Compensation Procedure

5. Manufacturing and sales activities－In providing products to customers, we comply with the Pharmaceuticals andMedical Devices Act, these Guidelines and the Codes of Practice and ensure theexcellent quality and stable supply of products manufactured and sold.
Provision of products
1. As a manufacturer and seller of products, we operate our businessappropriately and smoothly in compliance with applicable laws and regulations
under the supervision of general manufacturing and sales managers.

19

2. In assuring the quality of our products, we comply with the Ministerial Ordinanceon Standards for Quality Assurance (GQP Ministerial Ordinance). If any quality
problem occurs in one of our products, we promptly take action, including
voluntary recalls prioritizing human life, reporting to the authorities, andinvestigating the causes to prevent a recurrence.

6. Post-marketing safety measures and surveillance－ We thoroughly implement safety measures for products and conduct proper
post-marketing surveillance and testing
Post-marketing safety measures
1. After marketing products, we constantly collect safety information, promptly
evaluate and review the collected information, report it appropriately to theauthorities, and provide it to healthcare professionals.
2. In collecting data to create revaluation materials, we comply with the
Ministerial Ordinance for the Post-Marketing Surveillance and Testing ofPharmaceuticals to ensure the safety and eﬀectiveness of products.

[Reference Laws and Regulations]
Act on Securing Quality, Eﬃcacy, and Safety of Products Including Pharmaceuticals
and Medical Devices; and others[Reference External Standards]
GVP Ministerial Ordinance; GPSP Ministerial Ordinance; and Regulations for
Enforcing the Fair Competition Rules

20事業継続計画（BCP）
NIPRO
Compliance Action Guidelines－When applying for product manufacturing and sales approval, we ensure thereliability of scientific quality and test results and use objective and reliable test
data appropriately.
Application for approval
When applying for manufacturing and sales approval, we comply with relevantlaws, regulations, and internal rules, use only scientiﬁcally accurate data, and do
not conduct any fraudulent activities, such as stealing, falsifying, replacing, orconcealing materials and data.

7. Clinical trials－In supporting clinical trials, we comply with applicable regulations, including theClinical Trials Act and other relevant ethical guidelines, pay attention to conflictsof interest, and pursue transparency.
Conducting clinical research
1. When conducting clinical trials ourselves or jointly with any other laboratory or
by outsourcing them to a third party by providing funds, we observe theClinical Trials Act, the Ethical Guidelines for Life Science and Medical Research
Involving Human Subjects, and other relevant rules.
2. When conducting clinical trials, we clarify each laboratory’s obligations andresponsibilities, pay attention to the subjects’human rights, conclude written
contracts, and ensure the transparency and fairness of the funds provided forthe trials.
3. When providing any beneﬁt or labor for clinical trials, we pay attention to conﬂicts
of interest and avoid any doubt about the reliability of the results of clinical trials.

21

[Reference Laws and Regulations]
Clinical Trials Act; and others[Reference External Standards]
Ethical Guidelines for Life Science and Medical Research Involving Human Subjects;
Fair Competition Rules; Transparency Guidelines for the Relationship between
Corporate Activities and Medical Institutions; and others[Reference Internal Standards]
Research Ethics Examination Regulations; Clinical Ethics Examination Rules; andothers

8. Manufacture, import, and export of products－When manufacturing products, we use the approved manufacturing methods andperform good manufacturing management and quality management.
Manufacturing
1. We comply with applicable laws and regulations, ISO, internal regulations, andcorporate ethics including GMP and PIC/S GMP guidelines when manufacturing
products.
2. If a problem occurs or is suspected to have occurred in the quality of a
product, we thoroughly investigate the facts and causes and promptly takeaction to solve the problem. At the same time, in accordance with theapplicable law, we appropriately report the problem and our actions tosupervisory authorities and issue a press release.
3. We consider environmental conservation and the safety of manufacturing
workers and people in the community.

22

NIPRO
Compliance Action Guidelines
事業継続計画（BCP）[Reference laws and regulations]Pharmaceuticals and Medical Devices Act; Ministry Ordinance on Standards for
Manufacturing and Quality Management of Medical Devices and Pharmaceuticals(GMP); PIC/S GMP Guidelines; Ministerial Ordinance on Standards for Quality
Management of Medical Devices and Pharmaceuticals (GQP); laws and regulations for
medical devices and pharmaceuticals of other countries where we do business; andothers[Reference External Standards]
ISO 9000 Series; and ISO 13485－When importing products manufactured at overseas sites, we ensure thatthey are manufactured in accordance with local and international laws andregulations and by approved manufacturing methods.
ImportProducts manufactured and imported from overseas are also subject to laws
and regulations in Japan applicable to medical devices and pharmaceuticals. We
import products manufactured overseas by following proper procedures,
including compliance with the Customs Act, and adequately manage them in thesame way as products manufactured in Japan.

[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; Narcotics and Psychotropics Control Act;
Customs Act; and others

23

－When exporting products, we follow appropriate procedures in compliance withapplicable laws and regulations in Japan and overseas.
ExportWhen exporting products, we follow appropriate procedures after fully conﬁrmingthat they are not subject to strategic goods or strategic technology controls, orother export regulations.

[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; Narcotics and Psychotropics Control Act,
Maritime Transportation Act; Customs Act; Foreign Exchange and Foreign Trade Act;
Export and Import Transaction Act; and others.

[Reference External Standards]
U.S. OFAC regulations; and others.

9. Stable product supply－We ensure stable and timely product supply in an appropriate manner, keeping in
mind that our products are essential for people’ s health and life.
Stable supply
Since our products are life-related, if they are not available or have defects,
patients cannot receive proper medical treatment. To avoid this inconvenience,
we strive to secure stocks of ﬁnished goods and raw materials, formulate andimplement business continuity plans, and maintain solid sales and logistics systems.

[Reference External Standards]
Ministry of Health, Labour and Welfare’s circular notice and action plan; Stable
Supply Guidelines; and others.

24

NIPRO Compliance Action Guidelines

10. Intellectual property rights－We recognize that inventions, utility models, designs, trademarks, and otherintellectual property rights are important assets of business operators.
Respect for intellectual property
Enterprises are always on a mission to develop and provide innovative technologies
and products to compete internationally.
We observe the following rules, recognizing that the results of research,development, and other operations (including inventions, utility models, designs,
new varieties of vegetation, copyrighted works, trademarks, know-how, andtechnical information; hereinafter referred to as“Results”) are essential assets(intellectual property) of a company.
1. We correctly record and manage Results and never disclose or divulge them toanyone wrongfully without going through the prescribed procedures. Employees
do not use the Company’s Results for their own or any third party’s interest,
whether during employment by the Company or after resignation.
2. When an employee has obtained Results belonging to the scope of theCompany’s business, he/she immediately notiﬁes the Company and properly andpromptly handles them. The Company promptly and appropriately applies forregistration of Results belonging to the Company to secure its right to the
Results.
3. We respect the intellectual property rights of other companies. We never25attempt to obtain Results or conﬁdential information of any other party
wrongfully. We never use any other party’s Results for our own research,development, or other business activities without the consent of the rightholder, even if we have obtained such Results or information lawfully.

[Reference Laws and Regulations]
Patent Act; Utility Model Act; Design Act; Trademark Act; Copyright Act; Unfair
Competition Prevention Act; and others[Reference Internal Standards]
Invention and Design Handling Regulations

patent

11. Environmental conservation－Recognizing the importance of environmental issues, we act responsibly as alife-related company.
Environment
1. In addition to global environmental issues such as global warming, ozone
depletion, and acid rain, environmental risks such as waste, water pollution,
and air pollution are critical issues worldwide.
2. To contribute to the preservation and improvement of the global environment,
we pay keen attention to the environmental impact of all our operations̶not
only manufacturing but also R&D and marketing activities. We strive to use
resources and energy eﬃciently, reduce emissions, promote recycling, andprovide thorough education. We evaluate the environmental impacts of our
products and production processes and take action to reduce them,promoting the development and use of environmental technologies.

26

NIPRO Compliance Action Guidelines

3. If any incident or condition occurs that has caused or has a risk of causing harmto the environment, we promptly take proper action to remove the risk or alleviate
the condition. We also cooperate with local communities in environmental
conservation activities and provide correct and proper information.
4. Employees are encouraged to take environment-friendly actions in their daily
lives whenever possible, such as recycling waste and turning oﬀ unnecessary
lights, to reduce the environmental burden.

[Reference Laws and Regulations]
Basic Environment Act; Basic Act on Establishing a Sound Material-Cycle Society; Acton the Settlement of Environmental Pollution Disputes; Act on Compensation for
Pollution-related Health Damage; Air Pollution Control Act; Water Pollution Control Act;
Noise Regulation Act; Oﬀensive Odor Control Act; River Act; Puriﬁcation Tank Act;
Sewerage Act; Waste Management and Public Cleansing Act; Basic Act on Biodiversity;
Act on Promotion of Global Warming Countermeasures; Factory Location Act; Act on
the Rationalization etc. of Energy Use; Act on Prevention of Marine Pollution andMaritime Disaster; Act on the Promotion of Eﬀective Utilization of Resources; Act on
Securing the Recovery and Destruction of Fluorocarbons Contained in Speciﬁed
Products; Act on Special Measures against Dioxins; Act on Conﬁrmation, etc. of
Release Amounts of Speciﬁc Chemical Substances in the Environment and Promotionof Improvements to the Management Thereof (PRTR Act); Act on the Regulation of
Manufacture and Evaluation of Chemical Substances; Act on the Promotion of Sorted
Collection and Recycling of Containers and Packaging (Containers/Packaging
Recycling Act); Act on Asbestos Health Damage Relief; Ordinance on Prevention of
Health Impairment due toAsbestos; United Nations
Framework Convention on
Climate Change; ISO14001;
and others2712. Product information activities－We conduct fair and transparent information activities when providing
information to medical institutions and other organizations.
Activities to provide information
1. When conducting activities to provide product information to medical institutions
and others (provision, transmission, and collection of information), we comply
with the Code of Practice, the Fair Competition Rules, the Guidelines for
Providing Information on Prescription Drugs in Sales Activities to ensure fairness
and transparency in our information activities.
2. We acquire the medical and pharmaceutical knowledge necessary for providing
information. We provide appropriate product information to enhance andimprove the health of patients and the general public in accordance with theapplicable laws and regulations.
3. We provide information on our products to healthcare professionals within thescope of manufacturing and sales approval acquired for the product.
4. When conducting product information activities, we maintain a soundrelationship with doctors, pharmacists, and other healthcare professionals so
as not to violate or be suspected of violating the bribery provisions of thePenal Code, the National Public Service Ethics Act, the Fair Competition Rules,
and other ethics-related laws, regulations, and standards.

28

NIPRO Compliance Action Guidelines[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; Antimonopoly Act; the Ministerial
Ordinance on Post-marketing Safety Management Standards for Medical Devices andPharmaceuticals (GVP); Ministerial Ordinance on Standards for Post-marketing
Studies and Testing of Medical Devices and Pharmaceuticals (GPSP); and others[Reference External Standards]
Fair Competition Rule; Code of Practice; Creation of Guidelines for Providing
Academic Information on Oﬀ-label Use; and others[Reference internal regulations]
Code of Promotion; and others

13. Sales, publicity, and advertising－We conduct publicity and advertising activities with correct information andexpression.
Publicity and advertising
1. When providing information in sales, publicity, and advertising activities, we
comply with applicable laws and regulations and corporate ethics to ensure
the adequacy of these activities. We use correct and objective information andexpressions that are free of falsities, exaggerations, social discrimination, andhuman rights infringements.
2. When conducting activities to provide information to patients, investors,
audiences, and any other non-healthcare professionals, in addition to commercials
and press releases, we also carefully check the content of the information in theplanning stage so that it should not appear as advertising or publicity targeting
the general public.
3. We oﬀer only appropriate giveaways (such as prizes and awards) in compliancewith applicable laws and regulations and corporate ethics.
4. We maintain sound and fair relationships with advertising agencies, production
companies, and media companies.

29

5. When we use social media or other digital communications, we take full
responsibility for the content. We make sure that all related parties, including
subsidiaries, the parent company, aﬃliates, planning companies, agents, andemployees, understand and comply with this Code of Conduct. In particular,
we keep the following in mind:(1) We comply with the provisions of the Pharmaceuticals and Medical Devices
Act, the restrictions on advertising stipulated in the Standard for Appropriate
Advertising of Pharmaceuticals, and the Code of Promotion.
(2) When planning and supporting social media or any other similar online
communication means, we conﬁrm the appropriateness of the publication’scontent, including content posted by third parties. We take appropriate action
to prevent the posting of inappropriate content, such as the use of our productfor unapproved purposes, defamation or slander, or adverse events aﬀecting
competitors’
products.
(3) When we publish information, the appropriate department and an external
expert, as necessary, thoroughly examine the content.
(4) When we sponsor any social media, we explicitly display our company name.

[Reference Laws and Regulations]Pharmaceuticals and Medical Devices Act; Antimonopoly Act; Act against Unjustiﬁable
Premiums and Misleading Representations; Unfair Competition Prevention Act; andothers[Reference External Standards]
Fair Competition Rules; Standard for Appropriate Advertising of Pharmaceuticals;
Code of Promotion; Code of Practice; and others.
[Reference internal regulations]
Code of Promotion; and others30

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

14. Fair and proper transactions－We compete fairly and freely in the market.
Fair and free market competition
In both Japan and internationally, private monopolizing and unfair trade, which
impede fair and free competition in the market, is strictly prohibited by law.
These laws aim to protect consumer interests through fair and free competitionof companies and ensure the sound development of the economy.
In conducting business activities, we compete fairly and freely in the market incompliance with the local competition laws of each country.
1. We do not make arrangements with competitors to agree on bid prices orarrangements that aﬀect the selling prices or selling terms of products. We
refrain from participating in any organization or meeting that is suspected ofhaving an intent to make such arrangements.
2. We do not impose restrictions on wholesalers, distributors, or any otherbusiness partners for the purpose of maintaining the resale price of our
products, nor ask them to impose such restrictions on the transaction.
3. We do not solicit transactions by oﬀering illegal or inappropriate gifts,
entertainment, rebates, or any other similar favors to healthcare professionals,
or employees or oﬃcers of business partners.
4. We do not unreasonably restrict the business activities conducted by the otherparty to whom we provide technology or with whom we conduct joint researchand development beyond the scope of the legitimate purpose.

[Reference Laws and Regulations]
Antimonopoly Act; Act against Unjustiﬁable Premiums and Misleading Representations;
Penal Code; National Public Service Act; National Public Service Ethics Code,Companies Act; and others[Reference External Standards]
Guidelines for Distribution and Trading Practices under the Antimonopoly Act;
Guidelines for Patents and Know-How License Agreements under the Antimonopoly

31Act; Guidelines for Joint Research and Development under the Antimonopoly Act; theJapan Fair Trade Commission’s“Guidelines for Administrative Directive”; Fair
Competition Rules; and others

15. Engagement with public officials－We do not give or receive bribes in violation of laws and regulations.
Prohibition of bribery
Bribes to public oﬃcials are prohibited and are strictly regulated in many
countries.
We do not give, oﬀer, or promise bribery (money, goods, entertainment, favor,
and any other kind of beneﬁt) to public oﬃcials, deemed public oﬃcials, or otherpersons who are subject to the charge of bribery under special laws (hereinaftercollectively referred to as“public oﬃcials”).
We do not provide, oﬀer, or promise money or any other beneﬁts to foreign
public oﬃcials in violation of the local laws and regulations of the country and theJapanese Unfair Competition Prevention Act.

[Reference Laws and Regulations]
Penal Code (Giving and receiving bribery, Passing of bribes to a third party, andInﬂuence peddling); Unfair Competition Prevention Act (Prohibition against theProvision of Wrongful Gains to Foreign Public Oﬃcials); National Public Service Ethics
Act; National Public Service Ethics Code; National University Corporation Act; Act on
the National Hospital Organization, Independent Administrative Agency; OECD32

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

Convention on Combating Bribery of Foreign Public Oﬃcials in International BusinessTransactions; Federal Foreign Corrupt Practices Act (FCPA); and others[Reference External Standards]
Guidelines for Preventing Bribery to Foreign Public Oﬃcials (Ministry of Economy,
Trade and Industry, Jul. 30, 2015)[Reference Internal Regulations]
Guidelines for Engagement with Foreign
Government Oﬃcials; and NIPRO Bribery
Prevention Guidelines

16. Outsourcing to healthcare professionals－When outsourcing certain work to healthcare professionals, we conclude awritten contract with them and pay the appropriate amount of compensation.
Appropriate and fair relationships with healthcare professionals
1. When we appoint healthcare professionals as consultants, advisors, advisoryboard members, or to any other similar position, we conclude a written contract
with each of them to specify the details of the work to be entrusted, thecompensation, the delivery of work results, and other conditions.
2. The compensation paid for the work performed by healthcare professionals, suchas consultant fees and advisory fees, should be equivalent to fair market prices
according to the work entrusted to them.

33

17. Donations－ When donating to medical institutions, research institutes, academicorganizations, or other similar organizations, we confirm that the donation is
lawful. We offer money or items as a pure donation and do not request
anything in return from the recipient.
Donations to healthcare professionals and research institutes
1. Donations to medical institutions, research institutes, and academicorganizations must aim to advance medicine, pharmacy, or other public
interest. Even if money is given in the form of a donation, if the contributor
demands a favor in return, such as inappropriate solicitation of a transaction,
it is never acceptable because it violates the Fair Competition Rules.
2. If such inappropriate intent is suspected, we resolutely refuse the request fora donation to maintain an appropriate relationship.

[Reference Laws and Regulations]
Penal Code; and others[Reference External Standards]
Fair Competition Rules; and others

contribute

18. Avoidance of conflicts of interest and separation of private matters frombusiness－We avoid situations where the interests of the Company and the personal

interests of officers and employees may conflict. We do not pursue the interestsof customers or business partners at the expense of the Company’s interests
or receive illegal or wrongful benefits from customers or business partners.

34

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

Avoidance of conflicts of interest
1. If an oﬃcer or employee receives excessive personal entertainment or gifts
from a supplier, contractor, or customer, they may be biased towards giving
more favorable treatment to such business partner over other business
partners.
2. Gifts or entertainment within a socially acceptable range may not be seen as
illegal or inappropriate. However, conducting unfair transactions with business
partners against the Company’s interest may cause the oﬃcer or employee tobe accused of embezzlement, breach of trust, conﬂict of interest transaction,
aggravated breach of trust, or other crime.
3. Engaging in the business of another company or personal business competingwith the Company’s business may lead to unfair provision of proﬁts to suchcompeting business or hinder the proper performance of the Company’sbusiness.
4. We avoid acts that conﬂict with the Company’s interests, receive beneﬁts frombusiness partners, or engage in the business of a competitor, being aware thatit harms the Company’s interests and may constitute a violation of the law.

35

19. Accuracy of accounting records－We keep correct and accurate accounting books and records.

Appropriate bookkeeping and accounting records and compliance withlaws and regulations
1. In corporate accounting, we keep accurate accounting books and records of
the Company’s transactions in accordance with generally accepted accounting
principles and practices.
2. We establish and operate internal controls to ensure the reliability of securities
reports and other disclosures.

[Reference Laws and Regulations]Companies Act (Accounting books, Financial statements, Crime of an aggravatedbreach of trust by incorporators and oﬃcers, Crimes that put company property atrisk, Illegal dividends, and others); Financial Instruments and Exchange Act; Corporate
Accounting Principles; Rules for Consolidated Financial Statements; and others[Reference Internal Regulations]
Accounting Regulations[Reference External Standards]
Standards for Evaluation and Auditing ofInternal Control Over Financial Reporting

20. Proper use of company assets－We use the Company’s money and assets only to perform our duties.

No unauthorized use of Company money, goods, or other property
1. We use Company money, goods, and other property only to perform theassigned duties and do not embezzle them or use them for private purposesor for a third party.

36

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

2. Employees do not make false expense claims or use their position or authority
to beneﬁt themselves or a third party wrongfully. We follow any internal rules
and procedures established for the use of company assets.

[Reference Laws and Regulations]
Penal Code (Theft, Breach of trust, Embezzlement, Embezzlement on business);
Companies Act (Crime of an aggravated breach of trust by incorporators and oﬃcers,
crimes that put company property at risk); and others

21. Compliance with tax laws
－We comply with tax laws.
Compliance with tax laws
In our business activities, we always understand and comply with tax laws inJapan and overseas.

[Reference Laws and Regulations]
Constitution (Obligation to pay tax); General Act of National Taxes; National Tax
Collection Act; Income Tax Act; Corporation Tax Act; Local Tax Act; Consumption Tax
Act; Act on Special Measures concerning Taxation, Stamp Duty Act, Registration andLicense Tax Act; Customs Act; and others

3722. Network systems and information management－We properly manage and use internal and external network systems and do notillegally access these network systems or illegally create, share, leak, or tamper
with electronic information.

Proper use of network systems and digital devices
1. We use computers and other internal information processing systems
appropriately and eﬀectively, and do not use them for illegal purposes.
2. We properly manage electronic data and do not illegally acquire or reproduce
such data. We also take measures to protect sensitive information fromleakage, theft, destruction, viruses, and other damage.
3. If an employee suspects such damage, he/she reports it to the appropriate
department and takes action in accordance with internal procedures.

[Reference Laws and Regulations]
Penal Code (Unauthorized creation of electronic or magnetic records, Obstruction ofbusiness by damaging a computer, Computer fraud); and others[Reference Internal Regulations]
Information Security Policy Regulations

Network38

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

23. Handling of confidential information and respect for third party
confidential information－We strictly keep the confidentiality of information collected through our businessactivities and never disclose it to any unauthorized parties.
Strict confidentiality of information
1. Recognizing that the information possessed by the Company is criticalproperty, we do not disclose, provide, or leak it carelessly.
2. Understanding that we have an obligation to keep conﬁdential all conﬁdential
information of customers, shareholders, and other business partners, we do
not disclose it to anyone other than those who need to know it for performing
their duties.
3. Leakage or unauthorized disclosure of conﬁdential information of a business
partner may result in loss of trust from the business partner and society all at
once, and may result in civil and/or criminal actions against us. With thisunderstanding, we strictly follow applicable laws and the conﬁdentiality
agreement with the business partner when we acquire, use, manage, orotherwise handle their conﬁdential information.
4. We create, store, use, dispose of, and handle business documents (including
electromagnetic records) properly in accordance with laws and regulations
and internal regulations.

[Reference Laws and Regulations]
Penal Code; Unfair Competition Prevention Act; Financial Instruments and ExchangeAct; and others

Confidentiality39

24. Handling of personal information－We properly handle and store the personal information we possess.
Proper handling of personal information
1. Employees strictly keep conﬁdential and adequately handle all personal
information maintained at the Company during their employment and after
resignation in accordance with laws and regulations, internal regulations, and
the Privacy Policy.
2. We adequately follow the personal information handling procedures stipulated
by law, including proper acquisition, notiﬁcation and publication of purpose ofuse, prohibition of use for unauthorized purposes, safety management measures,
employee education, restrictions on disclosure to third parties, and response
to disclosure requests.

[Reference Laws and Regulations]
Penal Code (Unlawful disclosure of conﬁdential information by contractors);
Pharmaceuticals and Medical Devices Act (Obligation of conﬁdentiality of persons
undergoing reexamination, The obligation of conﬁdentiality of sponsors of clinical
trials, and others); Unfair Competition Prevention Act (Wrongful acquisition, use or
disclosure of trade secrets of other parties); Act on the Protection of Personal
Information; METI Guidelines for Economic and Industrial Sector regarding the Act on
the Protection of Personal Information; MHLW Guidelines for the Proper Handling of
Personal Information in Employee Management; Ethical Guidelines for Life Scienceand Medical Research Involving Human Subjects (Ministry of Health, Labour andWelfare Ministry of Education); Considerations for Handling Health Information in
Employee Personal Information Management (Ministry of Health, Labour and Welfare);
Guidance for Proper Handling of Personal Information by Health Insurance
Associations (Ministry of Health, Labour and Welfare); and others[Reference Internal Regulations]
Personal Information Handling Regulations

40

事業継続計画（BCP）
NIPRO
Compliance Action Guidelines

25. Working environment－We maintain a favorable working environment, improve employees’ health,comply with labor laws and regulations, and maintain a safe and hygienic
workplaces.
Conclusion and fulfillment of proper contracts and promotion of health andsafety in the workplace
1. We conclude labor contracts that are adequate for the jobs to be performed
to prevent the illegal dispatch of temporary staﬀ or ﬁctitious contracts.
2. We take necessary action to ensure that employees fully understand the termsof employment contracts.
3. We do not abuse our power, including disciplinary punishment, or give
unfavorable treatment to employees unilaterally.
4. We do not treat part-timers or other non-regular employees unfairly or
discriminatorily.
5. We comply with laws, regulations, and internal regulations related to healthand safety. We thoroughly manage safety and health in the workplace underthe basic policy of eliminating occupational accidents, preventing diseases, andmaintaining and promoting employees’health.
6. We always consider the physical and mental health of employees. We prevent
passive smoking at workplaces, in meeting rooms, in company cars, at
employees’social gatherings, and on other occasions in accordance with the
purposes of the Health Promotion Act.
7. We pay attention to the promotion of the physical and mental health of
employees and create a favorable working environment, which we continually
strive to improve.

[Reference Laws and Regulations]
Labor Standards Act; Labor Contract Act; Industrial Safety and Health Act; Act onChildcare Leave, Caregiver Leave, and Other Measures for the Welfare of Workers
Caring for Children or Other Family Members; Act for Securing the Proper Operationof Worker Dispatching Undertakings and Improved Working Conditions for41

Dispatched Workers; and others[Reference Internal Regulations]Childcare and Family Care Leave (Work) Regulations, and others－We guarantee workers’ freedom of association and right to collective bargaining,and build and maintain a healthy labor-management environment.
According to international norms and the local laws of each country, the unions
and the management of the Company work together faithfully to build good
relationships, improve the working environment and conditions, and maintain an
organization where people have trust and motivation.

[Reference Laws and Regulations]
Constitution; Labor Union Act; Labor Contract Act; Labor Standards Act; and others[Reference External Standards]
ILO Charter; standards; collective agreements; labor-management agreements; andothers42

NIPRO
Compliance Action Guidelines
事業継続計画（BCP）－We conduct transparent, fair, and objective personnel management.
No favoritism
We conduct transparent and fair personnel management. We do not discriminate
against people in hiring, performance evaluations, transfers, promotions,education, or other personnel aﬀairs on the ground of their relationship with any
oﬃcer, the person who manages personnel aﬀairs, or any other employee of theCompany.

－We support people with disabilities.
Support for people with physical, mental, or intellectual disabilities
We promote the employment of persons with physical, mental, or intellectual
disabilities.

[Reference Laws and Regulations]
Basic Act for Persons with Disabilities; Act on Employment Promotion etc. of Persons
with Disabilities; and others

43

－We evaluate the performance of employees objectively and fairly and create acomfortable workplace environment.
Objective and fair evaluations and a comfortable working environment
1. We objectively and fairly evaluate the performance of individual employees.
2. We create an environment where people can demonstrate their fullest abilities
in their work.
3. When accepting temporary employees dispatched by staﬃng agencies, webuild appropriate employment relationships in accordance with applicable laws
and regulations.
4. Upon leaving the Company, employees shall not inappropriately encourageothers to leave the Company to harm the continuation of employment or solicit
others to leave the Company and work with them.

[Reference Laws and Regulations]
Labor Standards Act; Act for Securing the Proper Operation of Worker Dispatching
Undertakings and Improved Working Conditions for Dispatched Workers; Unfair
Competition Prevention Act; and others[Reference Internal Regulations]
Employees Regulations, Professional Qualiﬁcation Regulations, and others

44

NIPRO Compliance Action Guidelines－We create a workplace free of harassment.
No inappropriate speech or behavior
Harassment hurts the personality and dignity of others, lowers the motivation ofothers, and impairs the workplace environment. We never tolerate harassment.
We never support harassers.
Harassing speech and behavior may directly lead to crimes. A harasser may besubject to civil and criminal liability. Fully understanding this, we strive toeradicate harassment by complying with the following rules:
1. Never touch the body of another person, repeatedly stalk someone or force asexual relationship. Never treat people unfavorably because they have refusedor reported such harassing acts.
2. Never exploit your superior position to deny the other person’s dignity byinappropriate speech or behavior, including violence, repeated reprimands orinsults, or ignoring the other person.
3. Never harass or treat employees who take leave for childbirth, childcare, orfamily care unfavorably.
4. Even if speech or behavior are not direct insults or do not fall under any of theharassment referred to in Items 1. to 3. above, they constitute harassment as longas they were intended to annoy or impose mental pressure on the other person.

[Reference Laws and Regulations]
Labor Standards Act; Equal Employment Opportunity Act; Act on Childcare Leave,
Caregiver Leave, and Other Measures for the Welfare of Workers Caring for Children
or Other Family Members; Revised Act on Comprehensive Promotion of Labor
Measures, and Stabilization of Employment of Employees, and Enrichment of Their
Working Lives (Power Harassment Prevention Act); and others[Reference External Standards]
Guidelines for Employee Management by Business Owners for Handling Problems
Arising from Sexual Conduct at Workplace; and others[Reference Internal Regulations]
Working Regulations; Harassment Policy; and others

45

26. Respect for human rights and fair and equitable treatment－We respect the human rights, values, personalities, and character of people weengage with and do not discriminate against them unfairly.
No discriminatory treatment
1. People around the world are quite diverse, including in terms of race,
nationality, ethnicity, gender, age, religion, creed and thought, social status,
sexual orientation, educational background, occupation, disability, healthconditions, and appearance. With solid awareness of our social responsibility
to contribute to the health and life of diverse people worldwide throughmedicine, we never tolerate unfair discrimination, harassment, or bias. We do
not treat workers unfairly and indiscriminately when hiring them or determining
the working conditions.
2. We comply with international norms on human rights. We respect the values
and personalities of each person, do not discriminate against them in any
situation, and treat them equally as a person regardless of their position orrole.
3. We never allow human traﬃcking and the resulting slave labor, forced labor to
repay debts, debt labor with limited freedom to quit, inhumane prisoner forcedlabor under harsh conditions, or organ transplants or traﬃcking contrary to
laws.

46

NIPRO Compliance Action Guidelines

4. We do not use conﬂict minerals such as tantalum, tin, tungsten, or gold fromthe Democratic Republic of the Congo (DRC) and its neighboring countries inAfrica because these minerals are the funding source for armed groups inthese countries where there are the problems of severe forced labor andinhumane trade.
5. We also declare the policy referred to above to our partners in the supply
chain and seek their understanding.

[Reference Laws and Regulations]
Constitution; Basic Act for Persons with Disabilities; Labor Standards Act; Equal
Employment Opportunity Act; Act for Securing the Proper Operation of Worker
Dispatching Undertakings and Improved Working Conditions for Dispatched Workers(Worker Dispatching Act); Equal Employment Opportunity Act for Men and Women;
Act on Organ Transplantation; and others[Reference External Standards]
Universal Declaration of Human Rights; International Covenants on Human Rights; UN
Guiding Principles on Business and Human Rights; OECD Guidelines for Multinational
Enterprises; ILO Tripartite Declaration of Principles concerning Multinational
Enterprises and Social Policy; U.K. Modern Slavery Act; OECD Due Diligence
Guidance for Responsible Supply Chains of Minerals from Conﬂict-Aﬀected andHigh-Risk Areas; U.S. Dodd-Frank Act, EU Conﬂict Minerals Regulation; and others[Reference Internal Regulations]
Working Regulations; Harassment Policy; and others

Respect for and securing children’s rights
1. We respect every child as a human being with fundamental human rights,
personalities, values, and character, regardless of race, nationality, ethnicity,
gender, age, mental or physical disability, or birth background, and regardlessof the social status, property ownership, criminal record, and any other statusof their legal guardians. We never tolerate any discrimination or prejudiceagainst children.

47

2. We give full consideration to children’s rights to ensure that no child isarbitrarily or unlawfully interfered with in their private life, family, residence, orcommunications, or unlawfully attacked on their dignity or fame, whether
mentally or physically, abused, neglected, or separated from their parents andthat every child can express their will freely.
3. In any circumstances, children must not be subject to economic exploitation orsexual objectiﬁcation or be forced to undertake labor or dangerous work
against their will. Children must not be placed in conﬁnement, be subject to or
shown cruel, inhumane speech or behavior, or unjustly deprived of theirfreedom. We declare this policy to interested parties and business partners inour supply chain and work with them to eliminate the infringement ofchildren’s rights.
4. We give full consideration to the support necessary for the medical care,education, and life of children so that all children can live with peace of mind
and grow up healthily and dream of a bright future for themselves.

[Reference Laws and Regulations]
Constitution; Act on the Prevention, etc. of Child Abuse; Child Welfare Act; Act on
Regulation and Punishment of Acts Relating to Child Prostitution and Child
Pornography, and the Protection of Children; Act on Advancement of Comprehensive
Service Related to Education, Child Care, etc. of Preschool Children; Labor Standards
Act; and others[Reference External Standards]
Convention on the Rights of the Child; Geneva Declaration on The Rights of the Child;Children’s Charter; Convention on the Rights of the Child; Declaration on the Rights of
the Child; International Covenant on Human Rights; and others

48

NIPRO Compliance Action Guidelines

No improper recruitment activities
1. When we use a recruiter who is not an employee of the Company, we use an
authorized recruiting agency and pay the appropriate range of compensation
permitted by law.
2. Such third-party recruiters must not receive money under any name from job
applicants or prospective new hires when oﬀering jobs on behalf of theCompany. We do not use such third-party recruiters.
3. When we decide on a new hire or accept a transferred employee, we neverreceive or demand payment or deposit of money under any name from job
applicants or prospective employees.

[Reference Laws and Regulations]
Employment Security Act; Act for Securing
the Proper Operation of Worker Dispatching
Undertakings and Improved Working
Conditions for Dispatched Workers; Labor
Standards Act; and others

27. Self-restraint and prohibition of improper acts in private life
－In our private life, we do not conduct acts that annoy other people or harm ourphysical and mental health.
No use of illegal drugs
We never possess, provide, receive, use, import, export, manufacture, orotherwise handle stimulants, unregulated dangerous drugs, or any other illegal
drugs.

49

[Reference Laws and Regulations]
Narcotics and Psychotropics Control Act; Cannabis Control Act; Stimulants Control
Act; Road Traﬃc Act; and others

No drunk driving
1. Fully recognizing that drunk driving can cause death or injury, we never drink
and drive, even in small quantities, under any circumstances. We also neverencourage drivers to drink alcohol and never ride a car knowing that thedriver is drunk.
If an employee is arrested for drunk driving or involved in a car accident
resulting in injury or property damage, he/she should promptly report it to theCompany.
2. We observe traﬃc rules when driving, including not using a mobile phone whiledriving, fastening seat belts, no illegal parking, no speeding, no driving in afatigued condition, and no dangerous driving.
3. Knowing our driving skills, we drive safely and smoothly, follow the traﬃc rules,
and give consideration to other cars and pedestrians.

50

事業継続計画（BCP）
NIPRO Compliance Action Guidelines

No criminal acts, misdemeanors, or violation of ordinances, laws, or regulations
1. The following acts are not permissible for any reason: assault, extortion,
intimidation, theft, embezzlement, fraud, vandalism, stalking, domestic
violence, abuse, abandonment, holding an unauthorized secondary job,groping, camera or video voyeurism, immoderate gambling, excessive drinking,having sensitive conversations in public, telling conﬁdential or undisclosed
material information to family members, leaking company conﬁdential
information on social media, and the like.
2. If an employee is arrested or punished or may be punished by the police or
any other judicial agency for any of the acts above, and if such dispositionaﬀects their work at the Company, the employee must promptly report theincident to the Company and follow its instructions.

28. Handling of whistleblowing and grievances－When we find any violation or suspected violation of laws and regulations, we
promptly report it to the Company.
The Company responds appropriately to reports of misconduct and never treatsa reporting person unfavorably because of such whistleblowing.
Proper handling of internal reports and no unfavorable treatment of whistleblowers
1. If an employee ﬁnds or receives a report from a subordinate about any
violation or suspected violation of laws and regulations, the employee must notconceal or neglect it but promptly report it to the Company to receive

51

instructions and take action accordingly.
2. Upon receipt of any inquiry, consultation, or internal report, the Company
responds promptly and appropriately, paying attention to the privacy of theparties concerned and handling the information.
3. We never treat employees unfavorably because of their reporting or
consultation under any circumstances.

[Reference Laws and Regulations]
Whistleblower Protection Act; Labor Standards Act; and others[Reference External Standards]
Guidelines for Private Enterprises Regarding the Development and Operation ofInternal Reporting Systems Based on the Whistleblower Protection Act (Consumer
Aﬀairs Agency)[Reference Internal Regulations]Management Risk Management Regulations; Whistleblowing Handling Regulations; andGrievance Consultation Oﬃce Management Rules

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29. Criterial for compliance with the Articles of Incorporation, internal regulations,and external charters and guidelines－We comply with internal regulations.
Compliance with the Articles of Incorporation, internal regulations, and other rules
We comply with the Articles of Incorporation, internal regulations and rules,
handling standards, and other procedures established through proper internal
procedures.

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NIPRO Compliance Action Guidelines－We also respect external charters and guidelines.
Criteria for complying with external charters and guidelines
We comply with the Japan Business Federation Charter of Corporate Behavior,and charters, guidelines, standards, and other rules established by other tradeorganizations with which the Company has direct or indirect relationships,
including the Japan Federation of Medical Devices Associations, the Medical
Technology Association of Japan (MTJAPAN), the Federation of Pharmaceutical
Manufacturers’Associations of JAPAN, and the Japan Pharmaceutical
Manufacturers Association.

30. Compliance with international rules and local laws and regulations andcontribution to local communities－We comply with international rules and the laws and regulations of each country
and respect local cultures and customs in our overseas business activities.
Compliance with international rules and respect for local cultures and customs
In conducting international business with a global view, we must not only befamiliar with and comply with domestic laws and regulations but also understandinternational treaties, local laws and regulations, and legal systems based on local

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cultures and customs, and pay attention to ethical values.
In our industry, international uniﬁcation of pharmaceutical laws and regulations
has been promoted. At the same time, competition laws are strictly applied, andsanctions (penalties) against infringement of the legal interests of otherbusinesses and individuals are often more severe than we think. Under thesecircumstances, we fully understand and realize that we must steer our business
management rooted in each region and comply with applicable local rules.

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NIPRO Code of Practice Handbook

NIPRO Compliance Action Guidelines Table of Contents
1st Edition : published
NIPRO CORPORATIONAll rights reserved2021