Doing Business with Integrity

THE SHIRE CODE OF ETHICS

Doing Business with Integrity

06-100GL v. 2.0

CEO letterDear Colleagues:

Ours is a business with many complex dimensions, so being alert to those situations that pose an ethical question requires an understanding of our underlying values, culture and policies. While we are always striving to deliver strong business results, how we achieve those results is as, if not more, important. Our work affects people’s lives, and this immense responsibility should always be top of mind. It is for all these reasons that we must always ask ourselves, “what’s the right thing to do and what’s the right way to do it?”

While fundamentally we trust that Shire employees understand the imperative to always exercise good judgment, sometimes what is right isn’t always clear. This Code of Ethics is designed to help you understand the aspects of our business where there may be an ethical dimension, and provide help in making the right decision. Of course no code or policy can answer every question or eventuality in a business like ours, so please speak to your manager if you are in doubt as to what to do.

By following the spirit of this Code and behaving in a manner consistent with our values, we will continue to earn the trust and respect of those with whom we work, and those we serve.

Sincerely,

DOING BUSINESS WITH INTEGRIT Y The Shire Code of Ethics2

Flemming Ornskov, MD Chief Executive Officer

July 2015

Section 1: IntroductionDoing Business with Integrity 5

The Importance of the Code of Ethics 5

Section 2: Our Code of EthicsOUR WORK ENVIRONMENT 7

Providing Equal and Fair Opportunities 8

Demonstrating Respect for Others 8

Maintaining a Safe and Secure Workplace 9

THE MARKETPLACE 10

Doing Business Free from Corrupt Activities 11

Protecting Fair Competition 12

Gathering Competitive Intelligence 13

Fair Treatment of Suppliers and Procurement 14

Protecting Privacy and Personal Information 14

PERSONAL INTEGRITY 16

Appropriate Use of Gifts and Entertainment 17

Avoiding Conflicts of Interest 19

Proper Handling of Inside Information 20

Responding to Investor and Media Inquiries 21

Responding to Government Officials 22

Conduct of Political Activities by Employees 22

OUR PRODUCTS 23

Providing Full and Fair Information about our Products 24

Global Trade Compliance 25

Product Quality and Adverse Events 26

PROTECTING COMPANY ASSETS 27

Keeping Accurate Books and Records 28

Protecting the Integrity of Company Technology 28

Safeguarding Intellectual Property 29

Protecting Confidential Company Information 29

Good Records Management Principles 30

OUR COMMUNITY 31

Respecting the Environment 32

Supporting Patient Groups/Organizations 32

Section 3: Being Brave Means Speaking Up

How to Raise Concerns 35

Company Resources 35

Contents

3DOING BUSINESS WITH INTEGRIT Y The Shire Code of Ethics

Introduction

4

DOING BUSINESS WITH INTEGRIT Y The Shire Code of Ethics

Doing Business with Integrity An important part of our Brave culture is recognizing that doing business with integrity is a shared responsibility for all of us at Shire.

Every person working at Shire, whether as an employee, consultant, contractor or in any other capacity, has a responsibility to act with integrity. How do you do this?

� Be honest in all of your dealings on behalf of Shire.

� Know and follow the laws, regulations and policies that affect your job.

� Seek advice whenever you’re unsure about what to do in a situation that seems to pose an ethical issue.

� Make ethical decisions.

� Speak up if you see ethical or legal problems, policy violations or other behaviors that concern you.

The Importance of the Code of EthicsWhy do we have a Code?As we strive to deliver strong business results, we want to make sure we achieve those results in the right way. Our business has many complex dimensions. It is absolutely fundamental that everyone working for or on behalf of Shire understands our values, culture and policies.

How should I use the Code?While we trust you to exercise good judgment, sometimes what is “right” isn’t always clear. This Code of Ethics is designed to help you make the right decisions, providing guidance in situations that may pose difficult ethical

questions or require difficult judgments.

What if the Code doesn’t answer my question?No single code or policy can answer every question or address every situation. Please speak to your manager or one of our compliance resources if you ever are in doubt as to what to do. You can access additional compliance resources by contacting one or more of Compliance, Legal, Human Resources, Internal Audit, Quality (supporting both R&D and manufacturing operations) and the Global Compliance Helpline.

What happens if someone violates the Code? Anyone who breaches the Code may be subject to corrective and/or disciplinary action. In serious cases, this may include dismissal or reporting to the appropriate authorities for action.

Do managers have additional responsibilities under the Code?Managers are usually the first people employees turn to with questions and concerns. Every Shire manager is expected to know this code, model ethical behavior on a day-to-day basis and make sure employees know what’s expected of them. When employees raise questions or concerns, managers should listen to the concerns objectively and address them effectively, including escalating certain issues to one of the appropriate compliance resources noted above.

What is Shire’s commitment to compliance?Shire is committed to marketing, selling, promoting, researching, developing, providing information about, and advertising the products it commercializes throughout the world in full compliance with applicable laws, regulations and codes. Specifically in the United States these include:

� Federal healthcare requirements

� Food & Drug Administration requirements

� Requirements of Shire’s Corporate Integrity Agreement

Back to Contents

5

Section 2: Our Code of Ethics

6

Our Work EnvironmentWe strive to create a work environment

where all people are valued so that they

can maximize their contribution to Shire’s

Vision and reach their full potential.

7DOING BUSINESS WITH INTEGRIT Y Our Work Environment

Providing Equal and Fair Opportunities

Our success is driven by diverse employee talent around

the world. We embrace and value all the things that make

us unique individuals.

YOUR ROLE

� Contribute to a supportive work environment that values different perspectives and ensures that everyone’s voice is heard.

� Speak up if you see someone being treated unfairly.

� If you hire anyone or make any employment-related decisions, make sure your evaluation is based on ability, skills, knowledge, work experience and job performance (when such information is available).

� Make sure you work with HR and Legal to understand what local labor and employment laws require in the areas where you do business.

ADDITIONAL RESOURCES

� Equal Employment Opportunity/Affirmative Action Policy 05-105US (US scope)

� Equality Policy 05-164UK (Outside US scope)

Demonstrating Respect for Others

Our employees, patients, business and society benefit when

we show respect, consideration and inclusion of different

perspectives in our work every day. The same applies to

our interactions with external business partners. Each of us

should contribute to a work environment that is free from

harassment and intimidation. Disrespectful behavior will not

be tolerated.

YOUR ROLE

� Never take actions that are intended to intimidate or harm someone.

� Avoid actions that could be considered harassment—even if meant as a joke.

� If you witness behavior that you believe is harassment, report it.

Wha

t to

Wat

ch O

ut F

or

Here are some examples of behavior that our Code prohibits:

� Jokes or slurs related to race, religion, ethnic origin or other personal characteristics

� Sexually explicit conversations, questions, stories or communications

� Teasing that causes someone to feel humiliated

� Unwelcome flirting or sexual advances

� Displays of inappropriate material

� Bullying or “ganging up” on someone

� Violence or threats of violence

What is harassment ?Typically, harassment is behavior the recipient

finds insulting, demeaning, hurtful, threatening,

or exclusionary. Harassment takes many forms

and can include words, gestures, or acts.

Be aware that behavior that is “acceptable” in your

home country may not be acceptable elsewhere.

? Q&A

DOING BUSINESS WITH INTEGRIT Y Our Work Environment8

Maintaining a Safe and Secure Workplace

We strive to help employees stay healthy and safe. We work together to

maintain a safe, secure and pleasant work environment, prevent injury and

accidents, and promote healthy lifestyles. The unsafe use of alcohol, drugs or

medication is prohibited, since this can lessen an employee’s ability to perform

their role and compromise the safety and well-being of fellow employees and

the public.

YOUR ROLE

� Always operate in a safe manner and avoid actions that you know could be dangerous or harmful.

� Never sell, purchase, possess or use illegal drugs.

� Never abuse alcohol or drugs while at work.

� Follow all building security procedures for your site.

� Report any threatening or potentially violent situations to HR or Corporate Security immediately.

� Report any unsafe acts or conditions right away.


� Please refer to the Health, Safety & Environment web page for additional guidance.

Shire reserves the right,

subject to local laws and

practices, to test applicants

and current employees and

contractors for illegal drugs,

alcohol or abuse of doctor

prescribed drugs.

If you or another employee

is struggling with substance

abuse, we have resources that

can help. Contact HR for more

information.

Back to Contents

9DOING BUSINESS WITH INTEGRIT Y Our Work Environment

The MarketplaceWe operate openly and fairly, understanding that our behavior and

business practices underpin our reputation. We observe both the

letter and spirit of the laws and regulations that govern our industry

in the global economy.

DOING BUSINESS WITH INTEGRIT Y The Marketplace

Doing Business Free from Corrupt Activities

We conduct business responsibly, ethically and free of any form of bribery or

corruption—regardless of local practice or custom.

Shire does not buy business. We prohibit bribery by employees, contractors or

any third parties acting on our behalf—regardless of local custom or practice.

YOUR ROLE

You are responsible for knowing and following Shire’s policies and procedures.

You must comply with anti-bribery and corruption laws.

� Be honest and transparent about the money you spend and the purpose for which it is spent. Never attempt to conceal or misrepresent a payment.

� Do not offer, give or promise anything of value for the purposes of influencing someone in a position of authority to make favorable decisions about our business.

� Oversee the work of third parties carefully. Make sure they do not engage in activity that is or could be perceived as, bribery or corruption as part of their work for Shire.

� Record all payments and expenditures accurately and honestly in the company’s books and records. The establishment of “off books” arrangements or “slush funds” is prohibited.


� Anti-Bribery and Corruption Policy 06-106GL

What is a bribe? Bribery is the act of offering,

promising or giving a financial

or other advantage to another

person with the intent to induce

improper performance of a

business or public function. We

tolerate neither giving nor re-

ceiving bribes. Anti-bribery laws

have severe penalties and often

apply outside of the countries

that have passed them.

? Q&A

11DOING BUSINESS WITH INTEGRIT Y The Marketplace

Protecting Fair Competition

Shire strives to win business based on superior products, service and

performance. We comply with competition laws, which prohibit agreements

between competitors that undermine the principles of fair competition.

We will not tolerate any behavior that prevents, restricts or distorts free and

fair competition, including:

� Agreeing with competitors to fix prices.

� Abusing a dominant market position (e.g., forcing a small player out of a market).

� Working with competitors to divide markets, customers or territories.

Competition laws are complex, global in reach, and operate differently in

different parts of the world. For specific guidance in your area, contact your

Legal or Compliance representative.

Free and fair competition

benefits patients and society

everywhere by providing

choice and competition.

Competition laws protect

patients and society by

encouraging free, fair and

open markets.

Wha

t to

Wat

ch O

ut F

or A bribe can be anything of value. For example:

� Gifts, entertainment or hospitality that is excessive, lavish or disproportionate

� Offers of employment being extended to a friend or family member

� Requests for donations to otherwise legitimate charities as a means to secure support for a business transaction

� Paying travel expenses or accommodation for an individual when there is otherwise no legitimate business purpose

� Use of Shire’s assets or equipment for activities unrelated to its business

� Accepting a gift, payment or other form of ‘kickback’ in exchange for directing business in a certain way

� Providing goods or services free of charge as a means to secure support for a business transaction

� Payment of so-called “facilitation” or “grease” payments to government officials to influence routine governmental actions – such as paying money to speed up processing of a visa

Offering or requesting a bribe is illegal in most countries—even if the transaction never takes place.


YOUR ROLE

� Never coordinate with a competitor or anyone else to fix prices or to take action that could lead to such a perception.

� Do not discuss or exchange information about Shire’s business with competitors (e.g., our sensitive commercial strategies, launch plans, pricing formulas, credit terms, promotions, discounts or allowances).

� Do not talk to competitors about dividing markets, customers or territories.

� Do not talk to competitors about placing restrictions on output or limits on production.

� Never take actions to manipulate a competitive bidding process or boycott a supplier, customer or distributor.

Gathering Competitive Intelligence

Shire gathers competitive intelligence ethically. Do not accept information if

you suspect it was obtained inappropriately.

YOUR ROLE

� It is acceptable to use public sources like websites, published articles and advertisements to gather information about competitors.

� Never engage in misrepresentation, deception, theft, spying, industrial espionage, piracy or bribery to obtain information. (See also Protecting Fair Competition)

� Seek guidance from Legal if you have any questions or concerns.


� The Shire Information Protection e-Guide

Wha

t to

Wat

ch O

ut F

or

Trade association meetings:

Make sure you clearly under-

stand the rules about discus-

sions with competitors. If

anyone starts to talk about

confidential business informa-

tion (e.g., price, markets, future

business plans), identify who

you work for and, if necessary,

leave the conversation.

Friends in the industry: While

it’s fine to maintain personal

friendships in our industry, be

very careful not to exchange

confidential business infor-

mation with a competitor or

someone who might repeat the

information to a competitor.

13DOING BUSINESS WITH INTEGRIT Y The Marketplace

Fair Treatment of Suppliers and Procurement

Shire deals fairly, responsibly and ethically with our contractors,

vendors and suppliers. We expect that they will do the same

in return. Procurement decisions must be based on customary

commercial considerations. We encourage and welcome

diversity in our supplier base, just as we do in our own business.

YOUR ROLE

� Deal fairly, responsibly and ethically with all of our contractors and suppliers.

� Award work to business partners on the basis of customary commercial considerations only.

� Do not take unfair advantage of others by deliberately manipulating, concealing or abusing information or misrepresenting material facts.

� Do not seek or accept special favors, gifts or arrangements with suppliers or customers.

� Make sure your supplier safeguards our information and physical assets. We expect our suppliers to keep our confidential information secure and we do the same for them.


� Supplier Selection Policy GPS-01

� Responsible Supply Chain Management Policy GPS-10

Protecting Privacy and Personal Information

Shire respects the privacy and safeguards the security

of the personal information we collect. Protecting it is

fundamental to our commitment to patients, healthcare

professionals, external business partners, employees and

the communities we serve.

YOUR ROLE

� Respect and maintain the privacy and security of the personal information collected by or for Shire.

� Never collect more personal information than is needed or keep it for longer than needed.

� Make sure that individuals have consented to Shire holding and processing the information.

� Know and comply with all applicable privacy laws and Shire privacy policies.

� Report any privacy breaches to [email protected].


� US-EU-Swiss Safe Harbor Policy


Most of the countries where Shire does business have laws that require us to protect and secure

the personal information of others that we collect or control. These laws are meant to protect the

personal data entrusted to us and generally require the following:

1) We give notice that we are collecting personal

information and explain how and why we use it.

2) We provide choices about its collection, use

and disclosure.

3) We provide access to individuals so their personal

information can be corrected, amended or deleted

upon request.

4) We maintain the integrity of the information so it is

reliable for its intended use and we retain it only for

as long as needed.

5) We limit access to and disclosure of the information

to third parties.

6) We use appropriate security safeguards to protect it.

7) We provide the means for individuals to ask

questions or register complaints about how we

handle their personal information.

Back to Contents

15DOING BUSINESS WITH INTEGRIT Y The Marketplace 15

Personal integrity underlies all of our efforts to

enable people with life altering conditions to

lead better lives.

Personal Integrity

16 DOING BUSINESS WITH INTEGRIT Y Personal Integrity

Appropriate Use of Gifts and Entertainment

We do not give or accept gifts, entertainment or hospitality that could

raise questions about our integrity or appear to generate an improper

business advantage.

Small gifts and meals are often used to create goodwill and build appropriate

business relationships. While these exchanges may be appropriate in many

business settings, they can also create real or perceived concerns about

personal integrity and undue influence—even when offered or accepted with

the purest of motives.

Whether or not a gift or offer of entertainment is appropriate will depend on

the circumstances. Be alert to what others, including competitors, might think

if the gift, entertainment or hospitality were made public. (See also Doing

Business Free from Corrupt Activities)

PLEASE NOTE: Specific gift, entertainment and hospitality rules apply to

our interactions with healthcare professionals which may differ by country

and location. Shire has specific policies covering such interactions in most

jurisdictions. You must familiarize yourself with local rules on interactions with

healthcare professionals. Severe penalties apply for violations in many places.

Even where permissible, all

gifts, entertainment and

hospitality must:

� Be modest and infrequent

� Be appropriate to the occasion

and not go beyond common

courtesy and accepted local

business practices

� Not consist of cash or cash

equivalents like gift cards or

gift certificates

� Keep within the bounds of good

taste—avoid inappropriate or

culturally insensitive forms of

gifts, entertainment or hospitality

� Not be in violation of the rules

of Shire or the recipient’s

organization

� Never be conditioned upon,

or be a reward for purchasing,

prescribing or promoting Shire

products and services

17DOING BUSINESS WITH INTEGRIT Y Personal Integrity

YOUR ROLE

Please follow these general guidelines to avoid both real and perceived

concerns about inappropriate exchange of gifts, entertainment or hospitality:

� Do not solicit gifts, entertainment or hospitality.

� Know and follow the local laws, codes and Shire policies, as there are some circumstances under which even modest meals, entertainment or gifts are prohibited.

� Exercise good judgment and moderation when providing or accepting business gifts, meals or items of value and seek advice if you are unsure.

� Maintain accurate and complete records of events where you provide anything of value.


� Please refer to the Global Compliance and Risk Management web page for additional guidance.

What do you mean by inappropriate or culturally insensitive forms of entertainment or hospitality? Certain venues or activities are not in good taste—for instance

gentleman’s clubs, venues that exclude women, hospitality

involving excessive luxury, and illegal activities. This is true

whether a Shire employee initiates the event or someone else

does. Always consider how your activities could reflect on Shire

if they were made public.

? Q&A


Avoiding Conflicts of Interest

Your personal interests must not influence your decisions or cloud your

professional judgment.

A “conflict of interest” exists when your personal, social, financial, civic or

charitable activities could conflict with Shire’s interests or compromise your

objectivity. Be aware that the activities of your relatives and close associates

can also create conflicts of interest.

Even the appearance of a conflict of interest can be damaging to you and to

Shire. The first step to address any real or perceived conflict of interest is to

disclose the issue to your manager. Many conflicts can be resolved quickly

and easily, in a way that is acceptable to both you and Shire.

YOUR ROLE

� Do not use your position with Shire to benefit yourself, your relatives or close associates.

� Be alert to situations in which your objectivity may be compromised. This includes situations in which your interests or the interests of your family or associates conflict with the interests of Shire.

� Know how to recognize a conflict of interest and watch for potential conflicts of interest in your work at Shire.

� If you think you may have a conflict, raise it with your manager right

away and work to resolve the conflict.


� Employment of Relatives Policy 05-117GL

Wha

t to

Wat

ch O

ut F

or

The following are just a few

examples of the many different sit-

uations where a conflict of interest

may arise; there are many others:

� Making procurement decisions when a family member or close friend stands to benefit personally, financially or otherwise, from the decision

� Hiring or managing relatives or close friends

� Working as a consultant, advisor, director or officer for a company that does business with Shire or is in the same business as Shire

� Taking personal advantage of opportunities you learned about as part of your role at Shire

� Using Shire property or information for a business opportunity that is not related to your role at Shire

� Competing with Shire’s business for personal gain

Thinking of joining an external

board where a conflict of interest

with Shire may exist? Please

consult with your manager before

making a commitment.


Proper Handling of Inside Information

We protect inside information and prohibit violations of

insider trading laws. Such violations are a serious offense

and can result in criminal prosecution.

Inside information, broadly, is information relating to

securities which is not in the public domain but which

an investor would consider important in making an

investment decision.

If you are in possession of inside information whether about

Shire or any other company as a result of your work at

Shire, you must keep that information confidential and you

must not trade in the relevant securities until the information

has been made public.

Also, you must not share this information with anyone else

who then buys or sells securities, including friends and

family members.

YOUR ROLE

� You must understand and comply with all applicable insider trading laws and Shire’s securities dealing policy.

� Never trade in securities when you have inside information. This includes inside information about companies other than Shire that you have learned about in the course of your employment at Shire.

� If you have any doubt as to whether you have inside information, consult with Legal.


� Securities Dealing Policy 06-105GL

What is Inside Information?Inside information is material, non-public information

which investors would consider relevant to making an

investment decision. Some examples include:

� Approval of new products

� Earnings statements or forecasts

� Negotiation of a merger, acquisition, licensing or

similar transaction

� Entry into significant new contracts

� Sales of assets or subsidiaries

� Changes in management

� Major developments in litigation or expected

governmental actions

� Clinical trial results

� Any information you obtained about Shire or another

company or entity on a confidential basis during the

course of your work

What are Securities?Securities include ordinary shares, American

Depository Shares (“ADS”), Stock Appreciation Rights

(“SAR”), or any other transferable financial instrument.

? Q&A


Responding to Investor and Media Inquiries

Take care not to speak for Shire—either inadvertently or on purpose.

As a company whose shares and other securities are traded on a stock

exchange, we are subject to rules and guidelines about when and how we

communicate certain types of information. To ensure clarity and a consistent

message, Shire has designated certain individuals to speak on the

company’s behalf to the media, financial analysts and investors.

YOUR ROLE

� Refer any external inquiries to Corporate Communications or Investor Relations. This includes questions from the investment community (e.g., shareholders, brokers, investment analysts, etc.) or the media.

� Do not make any statement to the press, radio or television about Shire’s business unless you have been specifically authorized to do so.

� Do not disclose unreleased financial information or any other non-public information to anyone outside the company.

� If you believe non-public information has been—or is about to be—wrongly disclosed, report it to your manager immediately.


� Media, Legal and Government Inquiries Policy 01-165GL

I've been asked to participate in a public forum on topics related to Shire's business. Can I participate?Check with your manager first.

In fact, you should check with

your manager before agreeing to

participate in any public event

related to Shire’s business.

? Q&A


Responding to Government Officials

It is Shire’s policy to cooperate fully with government

authorities in connection with requests for information,

site visits and investigations. Because these types of

inquires carry the risk of potential legal exposure or

financial liability to the company, they require the immediate

involvement of Legal or another appropriate department

depending on the nature of the inquiry.

YOUR ROLE

If you are contacted by a government agency or authority

regarding a non-routine request for information or a site

visit, you should obtain the name of the government official

seeking information and the agency they represent as well

as their contact information and then immediately contact

Legal, Regulatory, Compliance or another appropriate

department for guidance. The appropriate department

will coordinate any response to the government to ensure

that accurate information is provided, consistent with

legal requirements.

PLEASE NOTE: Shire attorneys are obligated to act in

the best interest of Shire and cannot serve as personal

attorneys for individual employees.


� Media, Legal and Government Inquiries Policy 01-165GL

Conduct of Political Activities by Employees

Shire supports the right of its employees to engage in

personal political activities outside of work. However,

personal political activity must remain separate from your

job responsibilities at Shire.

If you engage in the political process, make sure to do

it on your own time, with your own resources and avoid

suggesting that Shire has provided support.

YOUR ROLE

� Keep your work and political activities separate.

� Do not make political contributions, directly or indirectly, on Shire’s behalf.

� Do not lobby on behalf of Shire unless authorized by senior management.

� Do not use Shire’s company name, your job title, property or equipment, including e-mail, for personal political activities.

� While at work, do not solicit donations or try to persuade others to support political parties or candidates.


� If you have any questions about participation in political activities please speak to your manager or a member of our Government Relations team.

Back to Contents


We research, develop, manufacture and sell our

products understanding the responsibilities we have to

patients, health care professionals, payors and those

who regulate us. We know that our scientific methods

and business practices underpin our reputation.

Our Products

23DOING BUSINESS WITH INTEGRIT Y Our Products

Providing Full and Fair Information about our Products

Shire strives to provide balanced, fair and understandable

information about the safety and efficacy of our products

and their appropriate uses. We respect the need for

healthcare professionals to make unbiased clinical

judgments free from any inappropriate influence from

pharmaceutical manufacturers. (See also Appropriate Use

of Gifts, Entertainment & Hospitality)

Our marketing and educational activity is intended to

provide healthcare professionals, payors, and where

appropriate, patients with relevant medical and scientific

information so that they can make informed and

independent decisions about prescribing and using

our products.

Our promotional interactions and messages must always:

� Seek to educate but not interfere with unbiased clinical judgment.

� Be consistent with the approved label.

� Appropriately balance the risks and benefits of the treatment.

� Be truthful and not misleading.

� Be compliant with all Shire policies, applicable laws

and industry codes of conduct.

PLEASE NOTE: Specific rules apply to our communications

with healthcare professionals which may differ by country

and location. Shire has specific policies covering such

communications in most jurisdictions. You must familiarize

yourself with local rules on communications with healthcare

professionals. Severe penalties apply for violations in

many places.

YOUR ROLE

� You must conduct all communications with healthcare professionals about our products, including those relating to sales, marketing and scientific and medical information, in accordance with our principles and in compliance with all Shire policies, applicable laws and industry codes of conduct.


� Please refer to the Global Compliance and Risk Management web page for additional guidance.

24 DOING BUSINESS WITH INTEGRIT Y Our Products

Global Trade Compliance

Shire is committed to importing, exporting and engaging

in all forms of trade in a legal and ethical manner. As a

company we must comply with laws, regulations, licensing

requirements and boycotts or other embargos that have

been approved by recognized national and international

authorities, including the United Nations, the European

Union, the United Kingdom and the United States.

Such requirements may relate to, but are not limited

to, chemicals, biological materials, equipment, finished

products, and software and technology.

YOUR ROLE

� Provide accurate, truthful information about our products and other items to Customs and other relevant authorities.

� Refuse to engage in prohibited restrictive trade practices.

� Do not conduct business with parties subject to recognized trade restrictions.

� When in doubt, consult with your Global Trade Distribution, Legal or Compliance contacts.

? Q&A

What are Trade Restrictions?Trade restrictions, including

sanctions or embargos, seek

to prevent or omit trading with

one or more specific countries,

persons or entities.

A boycott is a country’s refusal to

do business or to prohibit others

from doing business with one or

more countries.

25DOING BUSINESS WITH INTEGRIT Y Our Products

Product Quality and Adverse Events

Shire is responsible for protecting patient safety by

ensuring its products are manufactured, stored and

distributed in accordance with all applicable quality

standards and by ensuring that any adverse events

experienced by patients using our products are promptly

reported to the appropriate authorities.

YOUR ROLE

� Know how to identify a product quality complaint or adverse event report.

� Recognize the information that you will need to collect when documenting a product quality complaint or adverse event report.

� Report any product quality complaint to the Quality Assurance department in accordance with the applicable policy.

� Pass on any adverse event report to the Pharmacovigilance department in accordance with the applicable policy.


� Reporting of Adverse Events Policy PV-001

� Reporting of Product Quality Complaints Policy QA-001

Wha

t to

Wat

ch O

ut F

or

Product quality complaints can include:

� Damaged tablets, capsules, vials

� Faulty packaging – inadequate closure/seal, missing/incorrect/misleading label, poor quality printing on packaging

� Contamination - foreign objects in pack/bottle/vial or packaging

� Overfilled/underfilled/empty capsules

� Product Mix (“rogues” within a pack/bottle)

� Wrong product (label and contents are different products)

� A product quality defect

Adverse event reports can include:

� Any unfavorable and unintended sign, symptom or disease associated with use of the product

� Exposure during pregnancy or lactation

� Misuse, abuse or overdose

� Withdrawal

� Diversion

� Lack of effect

� An unintended benefit

Back to Contents

26 DOING BUSINESS WITH INTEGRIT Y Our Products

We operate in the best interests of the company and its shareholders, protecting company assets and operating in compliance with the laws and regulations of the communities where we operate.

Protecting Company Assets

27DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets

Keeping Accurate Books and Records

Shire’s financial records must fairly represent our financial

condition and operations. As a company whose shares

and other securities are traded on a stock exchange, we

must abide by laws, regulations and accounting standards

for reporting and disclosing financial information, including

those set by the U.S. Securities and Exchange Commission,

the London Stock Exchange and the NASDAQ.

Operating in accordance with these standards ensures that

we can stand behind the integrity of the information that we

supply to shareholders, investors and governments.

YOUR ROLE

Shire’s Board of Directors and Financial Controller are

legally responsible for the information contained in

financial documents filed with Government agencies and

stock exchanges.

� To support them in their obligations, it is essential that everyone at Shire works to ensure the integrity and prompt, accurate reporting of business information. Never falsify records or misrepresent any facts in order to conceal the true nature of a transaction. Doing so may constitute fraud and may subject you and the company to criminal prosecution.

Protecting Company Technology

We use good judgment and follow company policies

when using company technology. All Shire employees are

responsible for helping to protect our hardware, software,

networks, mobile devices and information—assets that

are critical to our business success. Your use of Shire’s

technology should be appropriate, secure and primarily

for business purposes.

Do not assume that communications sent using company

technology are private. Subject to local law, Shire may have

the right to access, monitor and review all communications,

records and information created at work or with company

resources. In certain countries, you may need to produce

this information in the event of a lawsuit or investigation.

YOUR ROLE

� Do not download unauthorized software or other programs.

� Be reasonable and professional when using Shire technology. Don’t create, send or download content or communications that could be considered offensive, derogatory, defamatory, harassing, obscene or vulgar.

� Keep personal use to a minimum. Never use Shire computers for illegal activities or in ways that interfere with your work or the work of others.

� Do not use Shire computers or other assets in connection with an outside business.

� Take precautions to protect the security of computer systems, including corporate data, electronic communications and application software.


� Corporate Information Security Policy DOC-GBL-02

Other Government Reporting Requirements

In addition to our legal and accounting responsibilities, all

financial and non-financial arrangements with customers

must be properly recorded so that Shire can abide by all

government contracting and reporting requirements in

the US and other countries, as applicable.

28 DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets

Safeguarding Intellectual Property

Intellectual property rights are a key business asset.

Shire’s business is the discovery, development and

commercialization of innovative treatments and therapies.

Shire’s efforts are protected by intellectual property rights that

prevent others from copying and profiting from our work.

Intellectual property includes patents, trademarks,

copyrights, registered designs, trade secrets and domain

names (e.g. shire.com). We take steps to protect Shire’s

intellectual property rights. We respect the intellectual

property rights of others and we do not knowingly infringe

on any valid third party patents.

YOUR ROLE

� Respect and help preserve Shire’s intellectual property rights.

� Protect Shire’s business secrets by not speaking openly about or disclosing confidential business material to third parties.

� Document and make the company aware of new ideas, including technological or medical advances or unique solutions to business problems. Shire can then take steps to protect these new works under intellectual property laws.

� Please contact Legal without delay if you become aware of:

» New work that could benefit from intellectual

property protection.

» Any copying or misuse of Shire’s intellectual property.

» Suspected infringement of a third party’s intellectual

property by Shire.

Protecting Confidential Company Information

Confidential company information is a key business asset

that must be protected.

The products, services, ideas, concepts and other information

that Shire produces are a product of our hard work. They

require significant investment and are important and valuable

company assets. Shire owns this confidential or proprietary

information just as it does other kinds of property.

Shire employees at all levels have access to information

that is confidential or proprietary to the organization. We

all share an obligation to protect that information. The loss

or theft of Shire’s confidential information is a significant

risk to the company. We must also take care to respect

confidential information that belongs to people and

companies outside of Shire.

Examples of Confidential Information

Sales, marketing and other corporate databases

� Marketing strategies and plans

� Pricing information

� Customer and employee records Manufacturing

techniques

� Research and technical data

� New product development, ideas or projects

� Inventions, trade secrets and know-how

� Salary, wage and benefits data and all other

personnel information

29DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets

YOUR ROLE

� Respect your confidentiality obligations to Shire.

� Share confidential information only with other Shire employees who need to know it to perform their jobs.

� Make a habit of securing your workstation.

� Don’t discuss confidential business in public areas or work on it where others might be able to view the information.

� Before disclosing confidential information to outsiders, obtain prior approval from your manager and check to see if the recipient needs to sign a confidentiality agreement.

� Be aware of competitive intelligence activities by our competitors. Careless conversations can seriously damage Shire’s interests.

� Always respect the confidentiality and proprietary information of other companies and individuals, including physicians, scientists and patients.

� Report the loss or theft of Company laptops, devices or information to the Shire Global IT Service Desk immediately.

Good Records Management Principles

We manage our records and information in compliance with

laws and regulations.

Shire’s business is heavily regulated and its records and

information are essential company assets. We must meet

multiple requirements when we create, use, store and

dispose of company records and information. We may

face legal proceedings that require us to hold and preserve

relevant records and information. Failing to meet any of these

requirements can result in serious consequences including

loss or corruption of the assets, or sanctions and fines

against the company.

YOUR ROLE

� Be familiar with the Records and Information Management Policy plus any relevant recordkeeping policies or procedures applicable to your functional area. These procedures apply to records and information in any format, including electronic or hard copy.

� Be familiar with the Hold Orders issued by Legal if you are asked to preserve relevant records or information relating to a particular dispute or investigation. You must not alter or destroy records or information that are identified by Legal Hold Orders.

� If you have any questions, consult the Records & Information Management group at [email protected].


� Records and Information Management Policy

Back to Contents

30 DOING BUSINESS WITH INTEGRIT Y Protecting Company Assets

Our CommunityWe care about who we are and the legacy we leave behind. As a leader in many of the areas in which we operate, we have social and environmental responsibilities to ensure our position of strength is a positive force in society. This includes how we engage with our communities and how we manage our relationship with the environment.

31DOING BUSINESS WITH INTEGRIT Y Our Community

Respecting the Environment

We operate as an environmentally sustainable

organization, taking steps to protect the environment

wherever we conduct our activities. We strive to meet

or exceed regulatory requirements and maintain a high

level of environmental performance in the specialty

biopharmaceutical industry.

This means we:

� Promote the sustainable and efficient use of natural resources, waste minimization, recycling, energy efficiency and responsible product stewardship in our business activities.

� Integrate environmentally-sound principles and

practices into our day-to-day activities.

Good performance in this area is achieved by the

collaborative efforts of all employees.

YOUR ROLE

� Familiarize yourself with our environmental policy and adhere to its standards.

� Respect the environment and actively seek ways to help reduce our environmental impacts.


� Global Health, Safety & Environment Policy HSE-GP-01

Supporting Patient Groups/Organizations

Shire’s giving through grants and sponsorships to advocacy,

health and therapeutic-related organizations is guided by

our commitment to patients and the therapeutic areas in

which we work. Decisions about which patient organizations

to support and at what level are made in consultation with

our R&D and Medical Education units, ensuring that the

investments we make help patients and their families.

As part of our commitment to transparency and openness,

we disclose publicly on shire.com the patient groups we

support, along with a short explanation of how the funding

is intended to be used. In some countries, Shire is required

by law to disclose the amount and related details of the

financial support.

YOUR ROLE

� Know and follow the applicable policies to your business and region.

� Do not make donations, grants or sponsorships to Patient Groups or other organizations, directly or indirectly, on Shire’s behalf unless properly authorized.

� Make sure that any donations, grants or sponsorships to Patient Groups or other organizations are properly recorded and reported.

Back to Contents

32 DOING BUSINESS WITH INTEGRIT Y Our Community

Section 3: Being Brave Means Speaking Up

33

You are expected to speak up if you have questions

or if you see ethical or legal problems, policy violations

or other behaviors that concern you. When you

communicate honestly about how we are conducting

business, you show respect for your colleagues and

the patients who depend on Shire products and

provide us with an opportunity to address or correct

problems before they become significant.

34

How do I raise a concern?

In most cases you should contact your manager first and

ask for guidance. Shire expects managers to listen to your

concerns objectively and address them effectively. If you’re

uncomfortable talking to your manager or if your concern

involves your manager, please consult one of the additional

compliance resources listed below.

Could raising a concern hurt my job?

No. Shire does not tolerate any form of retaliation against

employees who report concerns or issues in good faith. For more

information please see our Whistle Blowing Policy 01-100GL.

Can I remain anonymous when contacting the Global Compliance Helpline?

Certain countries have laws regarding the use of company

helplines but in many cases you can remain anonymous*.

Why do we have a Global Compliance Helpline?

The purpose of the Global Compliance Helpline is to provide

a safe, secure way to ask questions or report concerns about

ethical problems, legal violations or violations of Shire policies or

procedures. If you are uncomfortable speaking to your manager

or one of the additional compliance resources available to you,

please contact the Global Compliance Helpline.

What types of issues can I report to the Global Compliance Helpline?

The Helpline can be used to report issues such as:*

� Fraudulent financial reporting

� Misconduct regarding sales and marketing policies

� Insider trading

� Data privacy breaches

� Disclosure of confidential information

� Environment, health and safety issues

� Harassment or discrimination

� Any other violations of Shire’s Code of Ethics

Compliance ResourcesThere are many resources available to assist you in making the right decisions and to report

concerns or violations, including:

� Your manager

� Compliance

� Legal

� Human Resources

� Internal Audit

� Quality (supporting both R&D

and manufacturing operations)

� Global Compliance Helpline

35

How do I contact the Global Compliance Helpline?

ON THE WEB

File a report online 24/7 in your native language at

www.Shire.Ethicspoint.com

BY PHONE

Call our trained specialists 24/7 to ask questions or discuss

concerns (translation services available):

� US & Canada: 1-866-747-4473

� UK: 0-800-032-8483 then dial 1-866-747-4473

� Other Countries: visit www.Shire.Ethicspoint.com for international dialing instructions

What happens after I contact the Global Compliance Helpline?

When filing a report with the Helpline, you’ll receive a

reference number for checking on a report’s status and will be

notified of any follow up actions taken. If there are questions

or more details are needed, a response will be posted on the

Helpline website under your reference number.

Other Questions?

If you have any additional questions about the

Helpline please email the Global Compliance team at

[email protected]

* Certain countries have laws regarding the use of company helplines. Please find additional details below.

FOR US EMPLOYEES:

Federal and state governments have enacted laws to prevent, detect

and punish health care fraud and abuse. At the federal level, these laws

include (but are not limited to) the Federal Anti-Kickback Statute (42

U.S.C. §1320a-7(b)), Federal Civil False Claims Act (31 U.S.C. §3729-

33), Federal False Statements Act (18 U.S.C. §1001) and administrative

penalty provisions under 31 U.S.C. §3801-12. Many states have enacted

similar laws. The federal FCA provides civil penalties of up to $11,000

for each false claim submitted to the government. Pharmaceutical sales

and marketing activities that might violate the FCA include (but are not

limited to) submitting false claims for government payment, fraudulently

reporting false pricing information to government agencies and similar

activities. The federal FCA, and some state FCAs, also include provisions

under which individual citizens with evidence of fraud against the

government may sue on behalf of the government to recover the lost

funds. These laws also prohibit retaliation against persons who file

whistleblower suits.

FOR EUROPEAN EMPLOYEES:

In most countries you may submit reports anonymously. In certain

European Economic Area (EEA) countries, however, laws may restrict

submitting anonymous reports and may limit the topics on which you can

report (for example, to bribery).

In such cases, reports should be made to your manager or you can

contact Human Resources, Legal or Global Compliance directly.

Further details are available on www.Shire.Ethicspoint.com.

Back to Contents

36

Last updated: 04/2015 06-100GL

Documents

Doing Business with Integrity