Code of Conductand Corporate Integrity

Boehringer Ingelheim USA Corporation and Its Subsidiaries

Boehringer Ingelheim Chemicals, Inc.

Boehringer Ingelheim Vetmedica, Inc.

Boehringer Ingelheim Roxane, Inc.and Roxane Laboratories, Inc.

Ben Venue Laboratories, Inc.and Bedford Laboratories™

Boehringer Ingelheim Pharmaceuticals, Inc.

CommunicationsCommunica-

WHAT IT MEANS TO WORK ATBOEHRINGER INGELHEIM

At Boehringer Ingelheim, we deliver Value through Innovationby living our fundamental principles of Lead & Learn.

We have high expectations for our employees. We require employeesat all levels of the organization to take initiative, stay connected,

grow together, and achieve outstanding results.

To enable high performance, we provide opportunitiesfor personal growth, a collaborative and inclusive work environment

and exceptional employee benefits.

We reward high achievement with recognition,opportunities and competitive pay.

We hold ourselves to the highest standard of excellence andcount on each other to go the extra mile in everything we do.

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Am I taking the initiative?

Are we taking the initiative?

Are we growing together?

Am I growing with others?

Am I actively implementing our ethicalvalues in my daily work?

Are we proactively incorporating our corevalues into our daily business activities?Are we ensuring that these concepts arethe foundation of our business plan?

Are we fostering a work environmentthat is committed to meeting our ethicalstandards – to performing with integrity?

Do I strive to contribute positively to mywork environment? Do I encourage othersto perform with integrity?

Letter from Our President and CEO

Dear Colleagues,

For nearly 125 years, Boehringer Ingelheim has remained focused on furthering science tobenefit the health of patients and their families. BI is a family company with a long historyof doing the right thing — for our patients, communities, customers and fellow employees.Patients and customers trust in the quality and safety of our products, employees trust thatthey will be treated with fairness and respect, and our business partners trust in our fair andhonest business conduct. We earn this trust every day by Performing with Integrity in every-thing we do — in our workplace, in the markets where we compete, at our Company, in ourcommunities and with the public.

This Code of Conduct and Corporate Integrity (“Code”) is designed to help ensure that wenever make ethical compromises and that we always act and make decisions in ways thatare honest and ethical. Each of us is responsible for reading this Code and ensuring that weunderstand and follow the principles it outlines. While it cannot anticipate every situationyou may encounter, our Code provides guidance for indentifying issues, getting advice andmaking ethical decisions.

If you ever suspect a violation of this Code, you must report it. If you have questions or wantadditional information, talk to your manager or reach out to any of the other resources out-lined in this document and listed in the “Resources” section at the end of this Code. Whenyou raise a compliance concern through any of these channels, you can be confident that youwill not face retribution or reprisal.

Our continued success depends on you — through both the decisions you make and theactions you take. As we move forward, I want to thank you for your continued commitmentto Performing with Integrity. It’s been the path of our success to date and will be for thefuture.

Sincerely,

J. Martin CarrollPresident and Chief Executive OfficerBoehringer Ingelheim Corporation

Table of Contents

Letter fromOur President and CEO

Notes About Our Code 1

Introduction 2

Making Ethical Decisions 3

Seeking Guidance and Reporting Violations 3

At-Will Employment 4

Performing with Integrity in the Workplace 5

Diversity and Inclusion 5

Discrimination and FairTreatment 5

Harassment–Free Workplace 5

Health, Safety and Environmental Protection 7

Employee Data Privacy 7

Performing with Integrity in the Marketplace 8

Compliance with Laws 8

Antitrust and Competitive Practices 8

Product Quality and Safety 9

U.S. Healthcare Laws 10

Marketing Integrity 11

Importation, Exportation and Interactions with Foreign Governments 11

Third-Party Interactions 12

Performing with Integrity at BI 15

Avoiding Conflicts of Interest 15

Confidential Information and Intellectual Property 16

Use of BI Electronic Communications Equipment and Systems 17

InsiderTrading 17

Records Management and Retention 17

Accuracy of Records 18

Ethical Research 18

Media and Public Relations 19

Performing with Integrity in our Communities and with the Public 20

Political Activity and Contributions 20

Boehringer Ingelheim Cares Foundation 21

Environmental Stewardship 22

Resources 23

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Notes About Our Code

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Throughout our Code, Boehringer Ingelheim andits Operating Units (OPUs) are collectively referredto as “BI” or “our Company.”

Laws and regulations are complex and subject tochange, and may vary from one site to the next.Company policies may also be subject to change,and may vary by job function. For these reasons,we must take care to familiarize ourselves with thepolicies, procedures and laws that apply to ourparticular jobs. If you wish to see the full text of allof our Company policies and procedures, visitWebBI or your local OPU intranet website.

Our Code is designed to communicate ourCompany’s commitment to complying with all ofthe laws and regulations that govern the manyaspects of our businesses. Not all of the laws,regulations or policies discussed in our Code mayapply specifically to your business or site. If youhave a question about how any aspect of our Codemay apply to your site or daily work, please contactyour manager or Corporate Compliance and Ethics.

Our Code provides guidance on BI’s standardsand information on key areas. However, nodocument can cover every situation that you mayencounter or every policy that may apply to youor your work. For the full text of all of ourCompany policies and procedures, visit WebBI orreference your local OPU policies andprocedures. It’s your responsibility to read,understand and follow the policies andprocedures that apply to your work. In theunlikely event of a difference between our Codeand our policies and procedures, follow ourpolicies.

Introduction

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Over the years, our Company has achievedsuccess and established trust with our patients,communities, customers, business partners andemployees through Performing with Integrity.At BI, Performing with Integrity means carryingout our Company’s ethical commitments andcompliance requirements on a daily basis. As BIemployees, we’re all expected to uphold thesecommitments in all of our business actions anddecisions.

Our Code forms the foundation of our ethicsand compliance program and shows us how tobetter Perform with Integrity. It guides us in ourday-to-day work by explaining BI’s high ethicalstandards and our legal responsibilities, as well asby providing concrete guidance for the behaviorsexpected of us.

Performing with Integrity is everyone’sresponsibility, regardless of position, location orlevel of seniority. This means that, whether you arean officer, director or other employee, you have aresponsibility to:

• Take the initiative to educate yourself about thepolicies and procedures that apply to your work

• Carefully read, understand and comply with ourCode, policies and procedures

• Ask questions if you are unsure or need guidance

• Report (and never ignore) any known orsuspected violations of our Code, the law,Company policy or other requirements

• Annually acknowledge and certify that you haveread, understand and will comply with our Code

• Participate in any required training

Regardless of your position or level at BI, youshould lead by example, demonstrate integrityand promote compliance with our Code at all times.If you are a manager, you have additionalresponsibilities to:

• Act as a role model by demonstrating acommitment to BI’s culture of ethics, integrityand trust

• Be an approachable, trusted and open resourcefor colleagues

• Ensure colleagues have access to the informationand training necessary to perform their work incompliance with our Code

• Respond promptly and follow through on anyconcerns raised by colleagues

• Be appreciative and supportive to those whoraise issues and concerns in an honest manner

• Uphold BI’s commitment to compliance byenforcing our Code and implementingappropriate corrective action or discipline formisconduct

Introduction

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Seeking Guidance and Reporting

Violations

If you reasonably suspect a potential violationof law or Company policy, you owe it to yourcolleagues and our Company to report yourconcern to any of the following individuals orgroups:

• Your manager

• Local management

• Our compliance and ethics resources

• Corporate Compliance and Ethics

• Our Legal Department

• Our Human Resources Department

• Our Compliance and Ethics Helpline at(800) 958-9704 or online atwww.boehringer-ingelheim.alertline.com

For your convenience, these resources are listedand explained in the “Resources” section at theend of our Code. You may choose to report anony-mously by contacting the Compliance and EthicsHelpline. The Compliance and Ethics Helpline isavailable any time by phone or online. Throughthe Helpline, you can:

• Report concerns or violations

• Seek guidance on ethical issues

• Request clarification on policies

• Communicate with our Company anonymously

Making Ethical Decisions

There are times when you may be unsure what todo, and there are some issues that may not beimmediately apparent or clear. In these situations,ask yourself the following questions to identifyand work through the issue:

1. Why is this bothering me?What is it that I’mconcerned about? Am I really unsure about whatto do, or am I just afraid to do what I know is right?

2. Who else matters?Who else will be affectedby the outcomes of any decision I make? Who elseshould be informed about and/or involved inmaking the decision?

3. Is it my responsibility?What is my role? Whatare my obligations? Do I have an opportunity tomake a difference?

4. What is the ethical concern? Is there somethingthat may be inconsistent with our Code, policiesand procedures, Lead and Learn, or Performingwith Integrity?

5. What do others think?Who should I ask foradvice and input? Even if others disagree with myjudgment, is there something I could learn fromthem?

6. Am I being true to myself?Would I feel proudto share my decision or actions with my family orhave them reported in the newspaper or eveningnews?

These questions, along with the training on ethicaldecision-making BI provides, will guide you inmaking ethical decisions. However, you shouldnever feel that you need to make a decision onyour own. If you are ever unsure about what to do,or have a sense that something may not be quiteright, ask questions and seek guidance from any ofthe resources listed in the next section, “SeekingGuidance and Reporting Violations.”

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The Helpline is managed by a third party. Whenyou contact the Helpline by phone, a representa-tive will listen to your concerns, ask you questionsand then review the information with you toensure it’s accurate. Helpline reports are providedto Corporate Compliance and Ethics within onebusiness day. When you contact the Helplineonline, you will be prompted for specific informa-tion relating to your concern. Whether you contactthe Helpline by phone or online, you will beassigned a confidential identification number thatallows you to retrieve a response or continue toexchange information with Corporate Complianceand Ethics.

Regardless of whether you report anonymously,both your identity and the fact that a report hasbeen made will be kept confidential to the extentpossible while still allowing a thoroughinvestigation. For more information about howthe Compliance and Ethics Helpline works, seethe Compliance and Ethics Helpline website onWebBI or on your local OPU intranet.

Non-Retaliation Policy

We must all be committed to creating an environ-ment where our colleagues can report a suspectedviolation, participate in the investigation processand engage in any other legally protected activitieswithout fear of retribution or retaliation. That’swhy BI has a strict “non-retaliation” policy, whichstates that no one may retaliate against us forraising an ethical or legal concern or for participat-ing in an investigation of such a concern in goodfaith. Acting in “good faith” means that you havegiven all the information you have and have madea sincere report — it doesn’t mean that your reportmust be validated. Please note that failure tofollow this policy may subject you to disciplinaryaction, up to and including termination.

If you feel you or someone else is being retaliatedagainst, report the situation immediately to yourmanager or any other communication channelidentified in BI’s Non-Retaliation Policy or yourlocal OPU policy.

At-Will Employment

Employment at BI is “at-will.” This means that,subject to applicable employment laws, nothingcontained in our Code and policies should beconstrued as creating any rights to employment forany specific duration or subject to any particularterms. BI reserves the right to modify, revise oralter any policy, procedure or condition related toemployment at its sole discretion and at any time,without notice and without revision of our Code.

Q: When I call the Compliance and EthicsHelpline, who is on the other end of thephone line?

A: The Helpline is managed by a third-partyvendor. Trained professionals employed bythe vendor answer the calls. They record theinformation in writing and send a copy toCorporate Compliance and Ethics for investi-gation or response. Helpline operatorsdo not answer questions or make any repre-sentations on behalf of BI.

Obligation to Report

If you are aware of an actual or suspectedviolation of law or Company policy, you arerequired to report it. By bringing potential viola-tions to BI’s attention, you help our Companytake action and resolve actual issues.

Investigations and Disciplinary Action

We have a duty to fully cooperate with anyinvestigation when asked. “Full cooperation”means that we are truthful and forthcoming withany information we have. BI reviews, evaluatesand responds to every concern, question andallegation of wrongdoing, regardless of how it’sreported, in a prompt and professional way thatrespects the rights of everyone concerned.Disciplinary action will be taken, up to andincluding termination, whenever warranted.

Performing with Integrityin the Workplace

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Performing with Integrityin the Workplace

The diversity and skill of our people is key to oursuccess. In order to foster a workplace thatattracts the best possible candidates andencourages innovation, we must treat each otherwith courtesy and respect. We conduct ourselvesethically and honestly at all times. This is thefoundation of Performing with Integrity in theworkplace.

Diversity and Inclusion

Our strength and competitive advantage lie in ourdiverse workforce. A diverse workforce helpsfoster fresh thinking and creative problem solving,and therefore enables us to compete moresuccessfully. We value our colleagues for boththeir similarities and their differences, ensuringthe continued presence of unique perspectives atBoehringer Ingelheim. Our vision is to continue toachieve an inclusive, highly diverse, flexible workenvironment that values and respects each of us.This environment promotes value throughinnovation, as well as higher levels of productivityand engagement.

Discrimination and FairTreatment

We are committed to providing a workplace freeof discrimination and one where all of ourcolleagues are treated fairly and with respect.This means we provide equal opportunity to allemployees and candidates for employment.

We do not discriminate on the basis of race,religious creed, color, national origin, ancestry, sex,marital status, sexual orientation, age, mental orphysical disability, gender identity, veteran status,pregnancy, childbirth or any related medicalcondition, or any other class or characteristicprotected by federal or state law.

Our commitment to fair treatment applies in allphases of the employment process. This includesactivities related to recruiting, hiring, promoting,training, compensating and other events. Pleaserefer to BI’s Equal Employment OpportunityCompliance Policy or your local OPU policy formore information.

Harassment–Free Workplace

We are expected to behave professionally and treateach other with respect in the workplace. BI doesnot tolerate harassment in the workplace or in anyother work-related setting, regardless of whether itis physical, visual or verbal. Generally speaking,“harassment” is any form of unwelcome behaviortoward another person that has the purpose oreffect of creating an intimidating, hostile oroffensive work environment, such as unwantedsexual conduct, threats and offensive comments.Regardless of who is involved (whether a manager,colleague, customer, vendor, job applicant,contractor or other third party), harassment isinappropriate and won’t be tolerated. ReferenceBI’s Sexual/Workplace Harassment Policy or yourlocal OPU policy for more details.

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Q: A colleague confides in me that she feelspressured by another colleague to go on adate. She tells me that the overtures are sofrequent that she feels uncomfortable evencoming to work. She doesn’t report to me.Do I need to take any action?

A: Yes. Though she doesn’t report to you,you still have a responsibility to report apossible violation of Company policy to anyof the resources identified in the “SeekingGuidance and Reporting Violations” sectionof this Code. You should also encourage herto raise her concerns by using any of theseresources. Remember that our Company willnot tolerate retaliation against anyone whoraises a concern or reports a Code violation.

Because it can be difficult for us to discuss andraise harassment concerns, BI provides multipleresources, including anonymous reporting throughthe Compliance and Ethics Helpline. Remember,you will not face retaliation for making a good faithreport of actual or potential violations.

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Health, Safety and Environmental

Protection

Each of us has a role to play in providing a healthyand safe workplace, complying with all applicablesafety laws and protecting our environment. To doso, we must be sure to do all of the following:

• Attend required safety and environmentaltraining programs

• Learn and comply with the rules and practicesof our job designed to promote safety andprotect the environment

• Use all required safety devices and protectiveclothing and equipment

• Learn and follow building evacuationinstructions and procedures

• Understand how to properly handle anyhazardous materials in our work area

• Refrain from all acts and threats of violence

• Be aware of your surroundings

• Follow all rules relating to workplace alcoholand drug use

• Report all safety, health, fire or environmentalhazards or suspected releases to managementor the Environmental Health and SafetyDepartment

If you are aware of a safety or environmental issueor have a concern, address it immediately even ifit’s outside your area of responsibility. Failure toreport a safety or environmental issue can exposeour Company, and even you, to legal liability.

Employee Data Privacy

As employees, we entrust our personal informationto BI and certain of our colleagues. Through ourwork, we may have access to our colleagues’personal information, and it is our responsibility tosafeguard this information to the best of our abilityat all times. We may only access this informationwhen we are authorized to do so, and we may onlyshare it with those who have a legitimate businessneed to know it.

Performing with Integrityin the Marketplace

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Our industry is highly regulated and there aremany complex laws that govern our business.Performing with Integrity in the marketplaceensures that we follow not only the letter, but alsothe spirit, of the law. We do the right thing andput our customers, patients and the safety of ourproducts above all else.

Compliance with Laws

BI is committed to complying with all applicablelaws and regulations, including those governingthe discovery, development, manufacture and saleof pharmaceuticals. These laws and regulationsrelate to every aspect of our business, includingresearch, development, clinical, manufacturing,marketing, sales and distribution. Dependingupon your position, you may also be required tolearn about and follow current applicableregulations established for our industry by thePhRMA Code, the Food and Drug Administrationand international regulatory agencies, such asthose supporting international productregistrations.

We must all take our commitment to complyingwith all laws and regulations governing ourindustry seriously. Failing to follow these laws maysubject us to legal penalties, including fines andimprisonment. They may also result in damage toour Company’s reputation, loss of trust, loss ofbusiness and, most importantly, a compromise ofpatient safety.

Antitrust and Competitive Practices

We compete aggressively in the marketplace,but do so honestly, fairly and in accordance withall applicable antitrust and fair competition laws.These laws are designed to promote free and faircompetition in the United States and around theworld, prohibiting illegal agreements that restricttrade. We fully support and comply with U.S.antitrust laws, which are among the most compre-hensive set of laws affecting our business.

We must remember that almost any agreementwith a competitor, whether written or verbal, canhave consequences resulting in legal action underantitrust laws. When interacting with competitors,proceed with caution and only with the advice ofour Legal Department. When, from time to time,we enter into alliances with other organizations,we must be cognizant of fair competition laws.

You should be particularly careful in situationswhere interactions with competitors are likely tooccur. This includes events such as trade shows,conventions, or professional or trade associationmeetings. Avoid any activity that might createeven the impression of conspiring with acompetitor. Remember, sometimes even the mostinnocent conversations or actions can be misinter-preted. It’s best to excuse yourself orimmediately terminate a conversation if it turns tothe sharing of specific business practices.In addition, be sure that you only gather competi-tive business intelligence, such as clinical trialdata, in a legal and ethical manner. If you receiveunauthorized or confidential competitor informa-tion that you suspect may have been disclosed toyou inadvertently, do not use or disclose thisinformation. Instead, notify our Legal Departmentof the situation immediately.

Performing with Integrityin the Marketplace

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Product Quality and Safety

Our continued success depends on our ability toprovide effective products that improve the healthof the patients we serve. Customers and patientstrust in the quality and safety of our products, andwe monitor our products to ensure the level ofquality and safety they expect. If you becomeaware of any real or potential safety concernrelated to one of our products, you must report iton the day you learn of the event.

Product issues generally fall in one of two areas—adverse events or product complaints. Thedistinction is important for reporting procedures,discussed in the following sections.

Adverse Events

In general, an “adverse event” is defined as anyunexpected medical reaction associated with theuse of a drug in humans, whether or not it isconsidered drug-related. It could involve use of adrug product in professional practice, a drugoverdose (whether accidental or intentional), drugwithdrawal, or a drug working differently thanexpected. You must report any suspected adverseevent on the same day you learn of it.

Q: After a trade show, I ran into a salesrepresentative for a competitor at the bar. Wetalked about our families over a drink, butthen the discussion turned to the market. Thesales rep pulled out his company’s price listand showed it to me. He pointed at apharmaceutical product and said, “If youagree to not sell your version of this drugbelow this price over the next year, I’ll give youmy word that we won’t charge less for ours.”What should I have done?

A:Making even an informal agreement is anantitrust violation and could subject youand our Company to serious consequences.If you find yourself in such a situation, turningdown the sales rep’s offer is not enough.You should also end the conversationimmediately and report it to our LegalDepartment right away.

Adverse Event Reporting:For BIUSA/BIPI Products – Call (800) 542-6257(select #4),email druginfo.rdg@boehringer-ingelheim.comor fax to (203) 791-6225

For Roxane Laboratories –Call the Roxane Technical Product InformationDepartment at (800) 962-8364

For Bedford Laboratories – Call (800) 521-5169

For BI Vetmedica – Call (866) 638-2226

Q: I learned of an adverse event in the field,but the doctor does not want me to report it.She can’t attribute the event 100 percent toour drug. Should I report the event anywayand risk harming my relationship with thedoctor?

A: Yes. You must report any adverse event onthe same working day that you learn of it,regardless of whether the physician wantsyou to or not. This is a matter of patientsafety, and we must take all potential eventsseriously.

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Product ComplaintsIf you receive or personally know about a productcomplaint, report it as soon as you become awareof it.

Product complaints are categorized as:

• Any change in physical appearance,such as broken capsules, tablets or vials,or discoloration

• Functionality issues with dosing devices,such as:

- Metered-dose inhalers (MDIs) or a Spiriva®HandiHaler®

- Failure to deliver the labeled number of doses

- Adhesion difficulties with transdermalpatches

• Product mix-up

• Labeling issue

• Product tampering or adulteration

• Counterfeit product

No matter the type or source of the complaintor the manner in which it is made, BI takes allproduct complaints seriously and investigatesthem quickly and thoroughly.

U.S. Healthcare Laws

As part of the U.S. healthcare industry, we areregulated by many laws designed to prevent,detect and punish fraud and abuse. This includessuch laws and regulations as the Federal Anti-Kickback Statute, Federal Civil False Claims Act(FCA) and Federal False Statements Act.In general, these laws seek to:

• Prevent false or fraudulent claims in federalhealthcare programs, such as Medicare andMedicaid

• Ensure that decisions made by healthcareproviders about patient treatment or productuse aren’t influenced by personal gain

• Support patients by reducing the cost ofhealthcare and promoting the quality ofhealthcare services

As a leading pharmaceutical company, we fullysupport and comply with these federal laws as partof our commitment to Performing with Integrity.We also comply with all applicable state laws thatseek to prevent fraud and abuse in healthcare atthe local level.

BI strives to prevent, detect and report violationsof U.S. healthcare laws. We must all assist in thiseffort by reporting any known or suspectedviolations. Please note that U.S. healthcare lawsencourage reporting violations, such as byaffording whistleblowers certain protections underthe law. For instance, the FCA specifically allowsindividuals to file “whistleblower” suits if theyhave evidence of fraud against the government.Covered employers are prohibited from retaliatingagainst an employee based on lawful actions as awhistleblower.

Product Complaint Reporting:For products marketed under the BI label –Contact Technical Product Informationimmediately via phone at (800) 542-6257or via email attechprod.rdg@boehringer-ingelheim.com

For Roxane Laboratories’ products –Call the Roxane Technical Product InformationDepartment at (800) 962-8364

For Ben Venue Laboratory’s products –Call (800) 521-5769

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Marketing Integrity

We have a responsibility to ensure that all of ourmarketing and promotional materials contain abalanced and accurate discussion of the risks andbenefits of our products. This means we will notmisrepresent our products, services or prices, orthose of our competitors. We must base our salesand marketing material only on facts anddocumented research, and include all legallyrequired information. For more information,please see BI’s Product Promotion Guidance forField Representatives Policy.

We follow all laws related to reporting productpricing information. The way in which state andfederal governments reimburse and track the pricesof pharmaceuticals requires us to report our pricinginformation to the government. To avoid problemsin this area, it is Company practice to review anddocument all discounted pricing to customers.

Importation, Exportation and

Interactions with Foreign Governments

The United States, along with many countrieswhere we operate, has laws controlling the importand export of goods. For example, it is illegal totrade with countries where there is a U.S. embargo,to comply with boycotts not sanctioned by theUnited States or to trade with certain individuals ororganizations outlawed by the U.S. government.

If you are involved in importing or exporting,you need to be aware of the requirements andprocedures that apply to your job. Be sure tofollow all rules regarding classification, valuation,country of origin markings, documentation,declarations to local government agencies and theobtaining of government licenses.

As part of our commitment to integrity, we maynever make, accept or offer any form of improperpayment while conducting business on BI’s behalf.We abide by the U.S. Foreign Corrupt Practices Act(FCPA) and all applicable international laws,treaties and regulations that forbid bribery ofgovernment officials. We must follow these lawswherever we do business, regardless of local law orcustom. This means we may never offer, attemptto offer, authorize or promise any sort of bribe orkickback to a foreign government official for thepurpose of obtaining or retaining business or anunfair advantage. A bribe includes anything ofvalue, including gifts, cash and favors. “Govern-ment officials” include any elected official or anyfederal, state or local government employee orcontractor. Keep in mind that in some cases,employees of state university hospitals may alsobe considered state employees.

We also cannot attempt to circumvent these rulesby retaining a third party to engage in prohibitedactivities on our behalf. If you have any questionsabout whether a payment violates the FCPA,contact our Legal Department.

You should take special care when handling drugsamples. If your job involves the handling ofhuman pharmaceutical drug samples, you mustknow and comply with the requirements of thePrescription Drug Marketing Act (PDMA), as wellas Company policies regarding thehandling, storage and distribution of samples.Accurate documentation regarding the processof providing samples is critical. You may notdistribute product samples outside of theapproved PDMA process.

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Third-Party Interactions

While gifts, meals and entertainment are oftenexchanged as common business courtesies, thisactivity is highly regulated in the healthcareindustry. It’s important to be aware of what isright and wrong when exchanging such courtesies.As a general rule of thumb, don’t accept or offerany gift, meal or entertainment if it will (or evenmight) be perceived as intended to create any typeof obligation or influence.

Healthcare ProvidersThe rules governing interactions with healthcareproviders are critical to the way we do business.Healthcare providers (HCPs) are people or entitiesthat can influence the prescribing, purchasing,selling or utilization of a prescription drug.Examples include, but are not limited to,physicians, physicians’ assistants, managed carepersonnel, nurses, nurse practitioners, pharma-cists, pharmacy directors, medical associations,laboratory personnel, respiratory therapists orothers who influence the use of our products.Essentially, interactions must be professional innature and intended to provide education thatbenefits patient care.

We adhere to all applicable federal or state laws,as well as any ethics policies enacted by anyinstitutions, hospitals or managed careorganizations related to sales and marketingactivities and the acceptance of gifts. OurPremium Items Policy, Educational Items toHealthcare Professionals Policy and local OPUpolicies on gifts and giveaways to HCPs set outour responsibilities in detail.

BIPI has voluntarily adopted the Pharma-ceutical Research and Manufacturers ofAmerica (PhRMA) Code on Interactions withHealthcare Professionals. Building ethicalrelationships with healthcare professionals iscritical to BI’s success and our mission ofhelping patients. By adopting the PhRMA Code,BIPI has publicly reaffirmed its belief that ahealthcare professional’s care of patients shouldbe based — and should be perceived as beingbased — solely on each patient’s medical needsand the healthcare professional’s medicalknowledge and education.

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Here are a few key guidelines:

Payments: Payments to HCPs by pharmaceuticalmanufacturers are highly scrutinized by thegovernment. We therefore must closely monitorall fees and compensation paid for consulting orother services or advice. We must avoid any andall appearance of inappropriate influence.Payments for services must be pursuant to acontract, reasonable and at fair market value.In the case of continuing education programs orprofessional meetings, payments must beprovided to the organizer with no rules aroundtheir use.

Gifts: Depending on state laws, we mayoccasionally provide items of nominal value (nogreater than $100) that are designed primarily forthe education of patients or healthcare providers(such as wall charts or medical books). However,you may only provide them without obligationand they must have no value to the HCP outsideof his or her professional responsibilities. If anitem does not serve an educational purpose,even if it’s a pen or a coffee mug, it is notpermitted at all.

Meals: Depending on state laws, we mayoccasionally provide modest meals in a way that isconducive to sharing educational information.The meal may occur in the place of business (suchas a physician’s office or a clinic) or at a modestrestaurant that does not appear lavish and isconducive to conducting a business discussion.This means we should not entertain in sports barsor other venues that combine dinner andentertainment. Sales reps may only offer mealsin an in-office setting.

Recreation and Entertainment: Providingrecreation and entertainment, including ticketsto the theater or a sporting event, sportingequipment, or leisure or vacation trips, is notallowed. This holds true even for HCPs who servein speaker or consultative roles with us and even ifthe recreation is secondary to an educational

Q: Why must we record our spend to HCPs?

A: The pharmaceutical industry can offer greatbenefit to the medical community and thepatients it serves. However, we must becareful to avoid the appearance thatfinancial relationships between thepharmaceutical industry and the medicalcommunity might affect the independenceand integrity of the medical community.BI engages in various financial relationshipswith the medical community and providesit funding, directly and indirectly, throughgrants, sponsorships, continuing medicaleducation and charitable contributions.We need to record and disclose all suchpayments. In so doing, we retain publicconfidence in our Company and enable BIto develop its products to improve the livesof patients.

purpose. We must document in our internalsystem any payments or items of value tohealthcare providers provided by our col-leagues, customers or vendors on behalf ofour Company. This enables us to comply withcertain reporting requirements and provide amore complete picture of our spendactivities as a Company.

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PatientsThe rules set forth in interactions with “HealthcareProviders” can also extend to patients. Such rules,where applicable, make it illegal to provide any-thing intended to influence a patient to purchaseor request a product that is paid for by a federal orstate program. This includes programs orinitiatives involving Medicare Part D andMedicaid participants.

Government EmployeesGiving gifts or gratuities to government employeesis an area that is strictly regulated by law. Laws ongifts and gratuities vary by location, so it isimportant to know the law in the jurisdictionwhere you work. You must obtain prior approvalfrom management before offering or providing agift or gratuity to a government employee. Neveroffer a gift or gratuity that is unreasonable in valueor is requested by the government employee.Please note that the rules governing gifts andgratuities for foreign government employees areeven stricter than those governing our interactionswith U.S. government employees.

Q: The FDA is conducting a routine inspectionof our facilities, and we’re working throughlunch. Is it okay to purchase lunch for theinspectors?

A: No. Meals are considered “gifts” undergovernment ethics standards. However,you may certainly escort the governmentemployees to a place within your facilitywhere they can purchase refreshments forthemselves.

Performing with Integrityat Boehringer Ingelheim

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We have worked hard to earn the trust andrespect of all of our stakeholders. We haveaccomplished this by operating with the highestethical standards as we conduct our business,manage our business records and information,and report on our progress. This is how wePerform with Integrity at BI.

Avoiding Conflicts of Interest

We are committed to upholding BI’s reputationof integrity and trustworthiness by makingbusiness decisions with honesty and objectivity.We must therefore be free from any actual orpotential conflict of interest. In fact, we mustavoid even the appearance of a conflict of interestwhen dealing with other businesses or individualson behalf of BI. A “conflict of interest” occurswhen our judgment and loyalty are dividedbetween our responsibilities to our Company andto an outside interest, or when we perform abusiness action for our personal benefit or thebenefit of a family member or close friend.

To avoid conflicts of interest, follow these generalguidelines:

• Never let your personal interests interfere withyour duty to work in the best interests of BI

• Never accept any gifts of cash or cashequivalents

• If in doubt, ask yourself, “Would a fair personreasonably believe that my actions aremotivated by reasons other than myresponsibilities to BI?” If the answer is anythingbut “no,” chances are a conflict of interest exists

• Seek your manager’s advice promptly if youthink there is any potential conflict of interest

The best way to avoid a conflict of interest is todeal with our vendors, customers and otherbusiness partners in an objective, professionaland fair manner. If you are presented with apotential conflict of interest, disclose the situationto your manager immediately. If you need furtherguidance, consult BI’s Avoiding Conflicts ofInterest Policy or your local OPU policy.

Situations in which a conflict of interest couldpotentially arise include:

• Taking advantage of business opportunities foryour own personal benefit

• Accepting payments or fees for activities as acondition of doing business

• Accepting expensive gifts or entertainment frompeople or firms doing business with us

• Conducting Company business with a familymember or close friend

• Having a financial interest in a customer, vendoror other industry-related business

Performing with Integrityat Boehringer Ingelheim

Remember, the important thing is to informyour manager any time you are presented with apotential conflict of interest. Many times theseissues can be easily resolved through disclosure.

Q: At an offsite meeting, a vendor who hasbeen providing services to BI for severalmonths invites me to lunch. I accept andallow him to pay for the meal. Are myactions okay?

A: Occasional meals and nominal gifts areordinarily acceptable, so long as they don’traise a question about your objectivity.Evaluate the setting and cost of the meal, thefrequency of the vendor’s invitations, andwhether you have other potential businesspending with the vendor. When in doubt, erron the side of caution.

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Confidential Information and

Intellectual Property

We classify information based on its level ofsensitivity and potential impact to our Companyand our business partners. We must handleinformation classified as confidential with care.“Confidential” information is that which we arerequired by law to keep confidential or whereunauthorized use or disclosure could harm ourCompany or its business partners. This includesthird-party information that our Company hasagreed to handle in a confidential manner.Examples include sensitive business, technical orscientific information; information that is subjectto legal restrictions; negotiations with strategicbusiness partners; and information generated instrategic planning.

If you have access to confidential information,you are responsible for managing it carefully andtreating it according to BI’s Information Protectionand Inventions Policy or your local OPU policy.These policies outline how you should manageconfidential information, including its use andstorage, labeling requirements and encryption foranything sent over the Internet. Your obligation toabide by applicable information protectionpolicies continues even after your employmentwith BI ends.

The following guidelines give practical advice forprotecting our confidential information:

• Be extremely cautious when discussing orhandling confidential information in publicplaces and follow the “information protectionprinciples” found in our Information ProtectionManual when handling confidentialinformation

• When discussing projects or issues with formercolleagues, be mindful to avoid disclosingconfidential information. If you ever feel theyare trying to extract sensitive information,call our Legal Department immediately forassistance

• Do not discuss confidential Companyinformation in public places, such as airports.Remember, you never know who might belistening. Take care to guard your laptop andother electronic devices from view

• Never use personal email accounts to exchangeCompany confidential information

Our information protection policies also coverthe protection of BI’s intellectual property.“Intellectual property” means any inventions,discoveries or other works that give BI acompetitive advantage or could be destructiveto our Company’s reputation if disclosed. Allintellectual property that we make, invent ordiscover through or in association with our workfor BI is our Company’s property. We must alsorespect the intellectual property rights (includingcopyright, patents and trademarks) of others andnever infringe on these rights in any way.

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InsiderTrading

While working on behalf of BI, we may becomeaware of material nonpublic information about apublicly traded company, such as one of ourvendors. Material nonpublic information (alsoknown as “inside information”) is informationabout a company that is not known to the generalpublic and that could influence a typical investor’sdecision to buy, sell or hold that company’ssecurities. Buying or selling securities of acompany while you possess material nonpublicinformation (otherwise known as “insidertrading”), or sharing that information with some-one else who trades on it (otherwise known as“tipping”), is a criminal offense in many countriesand is prohibited by Company policy.

Records Management and Retention

It is extremely important that we manage ourbusiness records properly. There are manyregulatory and legal guidelines that dictate how weshould maintain, store and destroy employment,tax and other business records. You are expectedto be familiar with the record retention proceduresapplicable to your department’s activities. Theseprocedures govern all of our records anddocuments in any format, including electronic,paper and audio, wherever applicable. For moreinformation, please see BI’s Records ManagementPolicy. If you have any questions, consult theInformation Management Group. RecordsManagement procedures and requirements mayvary at OPU facilities, so check your local intranetor consult with your local OPU Legal Departmentfor details.

In addition, when you know of a legal requestfor documents or are notified by our LegalDepartment orTax Department of a disputeinvolving information you hold, you may not alteror destroy that information in any way—even ifthe document retention policy or procedure other-wise requires destruction. We must cooperatefully with all government investigations, as well asinternal and external audits.

Use of BI Electronic CommunicationsEquipment and Systems

Our Company has entrusted us with certain toolsto help us work more efficiently. These mayinclude computers, personal digital assistants,access to the Internet or BI’s intranet, printers,fax machines, telephones, voicemail or otherequipment. These tools belong to our Company,and there are some important rules you mustfollow when using them:

• You may make limited personal use of thisequipment, so long as your use does notinterfere with your job or our business activity

• All communications over the Company networkare subject to monitoring by our Companywithout prior notice

• Anything transmitted, received or stored on theCompany network or IT equipment is Companyproperty

• Don’t use Company email systems in anymanner that violates our Code or any Companypolicy, including sending or knowingly receivingoffensive, harassing or improper messagescontaining racial, religious, ethnic, porno-graphic or vulgar language or depictions

BI’s Electronic Communications Policy contains acomprehensive list of rules for proper usage.

Passwords: User passwords should berandom combinations of letters and numbers.Don’t share your password or write it down.Do change your password regularly.

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As a Company, we have also adopted a fourth“R”: Responsibility. Animal welfare is the respon-sibility of everyone involved in the research anddevelopment process. Each of us must takeappropriate actions to promote and support thewelfare of our laboratory animals. This concertedand united effort is essential to achieve, maintainand constantly improve the highest standards ofanimal care.

We recognize that humane animal care andeffective animal research directly correlate todata integrity and scientific discovery, which formthe foundation for developing safe and effectivetherapeutic options for patients in need.

Accuracy of Records

Our commitment to Performing with Integrityincludes our obligation to maintain complete andaccurate business records. Our records serve asthe basis for managing our business and help usmeet our obligations for accurate, timely andunderstandable disclosures and communicationsto colleagues, government agencies and thepublic. We are each responsible for preparing andmaintaining documents, reports and other recordsaccurately and honestly.

Incomplete or inaccurate information damages ourreputation, and falsifying or creating misleadinginformation can constitute fraud. If you becomeaware of any inaccurate or incomplete reports orrecords, report them immediately.

Ethical Research

We strive to contribute to a better and healthierworld by discovering and developing productswith high therapeutic value. None of theseadvances could be achieved without the use oflaboratory animals. So long as the use of animalsin research is scientifically necessary, we willcontinue to ensure that we are in full compliancewith the Animal Welfare Act and other applicableregulations and standards that uphold the humanecare and use of animals.

Our goal is to adopt the industry-recognizedprinciples of the three “R’s” (Replacement,Reduction and Refinement) within our researchand development programs. To achieve this,wherever possible we:

• Use non-animal scientific methodologies

• Continue to work to decrease the number ofanimals used

• Use techniques and procedures that eliminateor minimize the pain or distress of animalsubjects

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Media and Public Relations

We at BI have worked hard to build a reputationof integrity and trust. The news media and othersoutside our Company depend on us to provideconsistent, accurate and responsiblecommunications. We have processes in place toensure that we provide timely and accurateinformation on important business issues to ourmany constituencies. These include ourcolleagues, our customers, the media, patients,government agencies, our industry and the generalpublic.

If you receive a request for information fromoutside our Company, don’t respond. Instead,refer the request to the Public Affairs andCommunications team. Only members of thePublic Affairs and Communications team, or otherauthorized spokespersons, are permitted to issuestatements to the media and the public.

Q: Our Company has begun a recall of aparticular product. Because you haveworked extensively on the product,a reporter’s telephone call is referred toyou. The reporter asks if he can get somesimple background information. Shouldyou talk to him?

A: No. You should refer even simple back-ground questions to the Public Affairs andCommunications team. You may not speakto reporters on behalf of our Company,even if the reporter portrays the inquiry asroutine.

Performing with Integrityin our Communities and with the Public

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We pride ourselves in being responsible corporatecitizens. We give back to the communities inwhich we work and live, support those in need,and act as good stewards of the environment.That’s Performing with Integrity in our communi-ties and with the public — a commitment we allshare.

Political Activity and Contributions

BI respects and supports our right as individualsto participate in political activities. This includesactivities such as exercising our right to vote andsupporting political candidates, parties and causeswith our own time and funds. However, you mustensure that any political activities you undertakeare done with your own resources and on yourown time. Also, make certain that your personalpolitical activities, such as holding local office,do not give rise to a conflict of interest (or theappearance of one). Consult BI’s AvoidingConflicts of Interest Policy or your local OPUpolicy for more information.

Complex federal and state restrictions govern thetypes of political contributions companies canmake. In fact, corporate political contributionsaren’t allowed in some states at all. For thisreason, you should never undertake activities tosupport any candidates or political committeeson behalf of BI unless you are a member of BIGovernment Affairs. This means we may not makepolitical contributions on behalf of our Companyor use any Company resources, such astelephones, copying machines, postage meters,stationery, offices or vehicles, to engage in politicalactivities.

Q: I am very active in politics in my personallife, and I volunteer for a politicalfoundation. May I use my Company email tourge my friends, family and colleagues tosupport the foundation?

A: No. While BI encourages your personalinvolvement in political activity, it is notappropriate to use Company email or otherresources (including Company-suppliedcomputers and work time) for politicalactivities that are unrelated to Companybusiness.

Performing with Integrityin our Communities and with the Public

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mobile laboratories deliver hands-on bioscienceexperiments to students throughoutConnecticut each year.

• Patient Assistance Programs: Our PatientAssistance Program (PAP) provides our brandname prescription drugs free of charge to U.S.citizens and legal residents who meet theeligibility requirements and low-income criteria.We are continuously working to expand our PAPby introducing new offerings to those in need.

• Product Donations:We have built partnershipswith a number of domestic and internationalnonprofit organizations to distribute ourprescription drugs and over-the-counterproducts to those who are less fortunate.We are also active in global organizationsdedicated to raising the standards for medicalproduct donations.

• Charitable Contributions: BICARES Foundationmakes charitable contributions to local 501(c)3organizations that are aligned with the founda-tion’s philanthropic mission (e.g., access tohealthcare and math and science education)and that meet funding criteria.

• Employee Volunteerism:We have a reputationfor providing leadership in volunteer communityprojects and for working side-by-side withneighbors, local businesses, schools andgovernments to improve the quality of life forthe citizens in our communities. We encourageand support this type of activity in all of ourlocations.

Boehringer Ingelheim Cares Foundation

The Boehringer Ingelheim Cares Foundation, Inc.improves lives through philanthropic contributionsand donations of healthcare products andresources. The work of the Foundationdemonstrates our commitment to being a goodcorporate citizen. It also shows our commitmentto continuing to find innovative ways to provideaccess to our products for those in need.Improving access to healthcare and furtheringmath and science education for public schoolchildren have been the core foci of theFoundation’s philanthropic initiatives since itsinception. Some of the initiatives include:

• AmeriCares Free Clinic: We are a majorsupporter of AmeriCares, which provides qualityhealthcare to uninsured residents in an atmos-phere of dignity and respect. Our supportincludes sponsorship of the BoehringerIngelheim Free Clinic of Danbury, CT, the MobileMedical Unit that brings much needed servicesto home bound people and underserved areasof the community, as well as product donations.

• Science Education: We bring the lab to publicschool children through our sponsorship of amobile science laboratory with the ConnecticutUnited for Research Excellence (CURE)organization, an education nonprofit. Outfittedwith the latest in bioscience equipment andtechnology, these 40-foot, custom-designed

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Environmental Stewardship

“In all our activities, we will protect ouremployees, facilities and the environmentfrom harmful influences, conserve naturalresources and promote environmentalawareness.”

This statement demonstrates BI’s commitmentto ensuring that our business is not onlyeconomically viable, but also socially responsibleand acting in an ecologically sustainable manner.We have made a firm commitment to safety,quality and environmental protection. We act oncore, worldwide corporate principles to upholdthis commitment. We continuously work to adaptand improve the way in which we operate,minimizing environmental, safety and health risksand fostering an open and constructive dialoguewith organizations and individuals.

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• Legal Department: Your local OPU LegalDepartment can provide guidance withquestions concerning laws, regulations,Company policies and acceptable businesspractices.

• Human Resources Department: HumanResources personnel are available to addressmany issues and concerns, particularly thoseinvolving discrimination, harassment or otherinterpersonal issues.

• Compliance and Ethics Helpline: Contactthe Helpline to anonymously report concernsor instances of suspected non-compliance, seekguidance on ethical issues, request clarificationon policy-related questions and provideinformation to Corporate Compliance andEthics. You may either identify yourself or makean anonymous report. You can reach theCompliance and Ethics Helpline by phone(800) 958-9704 or emailwww.boehringer-ingelheim.alertline.com

• BI Company Policies and Procedures Website:The Policies and Procedures website providesaccess to Company policies, procedures, SOPsand guidelines, as well as announcements ofnew or recently revised policies and procedures.

Resources

When you have a question or are seekingadditional information or guidance on any ofthe information in our Code, there are manyresources available to help you. It’s always a goodidea to start with your manager, but if you aren'tcomfortable doing so or this option isn't availableto you, you can contact any of the followingresources:

• Local Management: If you are unable toaddress your questions/concerns with yourmanager, reach out to a member of your localmanagement team.

• Compliance and Ethics Resources: Local orCorporate Compliance and Ethics resources areavailable to answer your questions and provideguidance. The Compliance and Ethics websiteprovides additional information, training andlinks to other resources and the online Helpline.

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