the way to compliance Novo Nordisk Inc. U.S. Code of Business Conduct

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1 the way to compliance Novo Nordisk Inc. U.S. Code of Business Conduct

2 U.S. Code of Business Conduct fifth edition patients ambitious accountable innovation open & honest

3 Table of Contents Compliance Contact Numbers 4 From the President 5 U.S. Code of Business Conduct 6 Purpose 6 Scope 7 The Novo Nordisk Way 7 Corporate Compliance Program 8 Compliance Organization 8 Program Objectives 8 Reporting Compliance Concerns 9 The Marketplace 10 Healthcare Laws, Regulations, and Guidance 10 Marketing of Our Products 10 Interactions with Healthcare Professionals and Organizations 11 Transparency 11 Payments to Healthcare Professionals for Bona Fide Services 12 Meals, Gifts, and Entertainment 12 Product Samples 12 Clinical Research 13 Interactions with Patients 13 Product Safety and Adverse Event Reporting 13 Community and Patient Health Education Grants 14 Grants for Third-Party Educational or Scientific Meetings 14 Grants for Research 14 Antitrust and Competition Laws 15 Bribery 15 Fraud 15 Our Company and Co-Workers 16 Equal Employment Opportunity and Anti-Harassment 16 Anti-Retaliation Policy 17 Open Door Policy 17 Conflicts of Interest 17 Gratuities, Gifts, Entertainment, and Other Things of Value 18 Competitive Intelligence 18 Enforcement and Discipline 18 Confidentiality, Privacy, and Security 19 Insider Trading 19 Company Records and Document Retention 20 Intellectual Property 20 Information Technology 21 The Public and the Community 22 Our Triple Bottom Line 22 Social Responsibility 23 Environment, Health, and Safety 24 External Communications with the Media and the Public 25 Interactions with Government Representatives and Investigators 25 Appendix A: Healthcare Laws, Regulations, and Guidance 26 Appendix B: Contact Information 29

4 The Novo Nordisk Inc. U.S. Code of Business Conduct and the policies and procedures stated and referenced herein are not to be interpreted as a contract for employment (real or implied) between Novo Nordisk Inc. and its employees. Novo Nordisk Inc. maintains the right to change or terminate the U.S. Code of Business Conduct and its policies and procedures at any time, with or without notice. Nothing in the Code is meant to change the status of an employee s employment with Novo Nordisk Inc. Novo Nordisk subscribes to an employment at will practice. This means that an employee can terminate his or her employment at any time and that the Company can decide to end the employment relationship at any time and for any reason, so long as the reason is not discriminatory and does not otherwise violate the law. Nothing in the Code is meant to change the at will status of an employee s employment with Novo Nordisk Inc. For additional information, please consult the policies and procedures referenced throughout the Code. Compliance Inquiries Compliance Inquiry Helpline (609) Compliance Inquiry Novo Nordisk Compliance Intranet Internal: NNI Compliance Assistance External: NNIComplianceassist@novonordisk.com legal/pages/legalintellectualcompliance.aspx Reporting Compliance Concerns Line Management Incident Reporting Hotline (Toll-Free 24/7) Incident Reporting Intranet Website (anonymous) Novo Nordisk Inc. Human Resources, Legal, and Compliance Departments If possible, first consult your line manager (888) (calls may be made anonymously) NNIComplianceassist@novonordisk.com (609) (main number) The online version of the Novo Nordisk Inc. U.S. Code of Business Conduct residing on the Novo Nordisk Inc. Intranet Compliance Website ( supersedes any other electronic or print version of this Code. Furthermore, the governing version of every Novo Nordisk Inc. policy or procedure accessed through this Code resides on ISOtrain or the Novo Nordisk Inc. Intranet. 4 Novo Nordisk Inc. U.S. Code of Business Conduct

5 From the President Dear Novo Nordisk Inc. Colleagues: Over the past few years, Novo Nordisk Inc. has grown well beyond the dreams of many. The size of our sales force has increased dramatically and the number of employees at the home office has grown proportionately. Throughout this time of growth, our values have remained consistent. Novo Nordisk Inc. is committed to strictly complying with all applicable laws and regulations and adhering to the highest ethical standards in all of its activities. The U.S. Code of Business Conduct is designed to help you represent the Company in accord with our values and to understand the relevant legal and regulatory parameters. It is important to remember that while the U.S. Code of Business Conduct addresses most of the issues that arise in the course of business, it is not possible to cover every scenario. Therefore, every employee is expected to ask questions and express concerns through the appropriate channels, as needed, to ensure that our values are upheld. It is only through this open dialogue that the Company can maintain the trust of internal and external stakeholders. Our values have helped to shape our reputation. Let s reinforce our commitment to our values as we continue to grow and meet the needs of patients. Sincerely, Jesper Høiland President, Novo Nordisk Inc. Novo Nordisk Inc. U.S. Code of Business Conduct 5

6 patients We create value by having a patient centred business approach. ambitious We set ambitious goals and strive for excellence. U.S. Code of Business Conduct At Novo Nordisk Inc. (Novo Nordisk, or the Company), defeating diabetes is our vision, our passion, and our social responsibility. In doing so, we are committed to the highest ethical standards of business conduct. Purpose Our U.S. Code of Business Conduct states the ethical and compliance principles that guide our company, our employees and the interactions we have with our stakeholders. Our Code ensures that our values are reflected in daily work and that we enhance the transparency of our activities for all stakeholder groups. It informs and directs business practices as outlined by our Corporate Compliance Program and corporate philosophies and reflects the Novo Nordisk Way our global commitment to patients, our employees and our shareholders. Novo Nordisk is committed to compliance with all federal healthcare program and Food and Drug Administration (FDA) requirements in all of our activities, including the way we market, sell, promote, research, develop, provide information about, and advertise our products. Finally, our employees must understand that failure to adhere to the Code could impact Novo Nordisk s global reputation and have financial and legal consequences outside of the U.S. What if I am not sure how or if the Code applies in a situation? If you are uncertain about how the Code applies to a particular situation, or if there is a situation that does not seem to be covered by any policy or procedure, you should discuss the issue with your line manager. If you have met with your line manager and feel you need additional information, consult the Human Resources, Legal, or Compliance Department. 6 Novo Nordisk Inc. U.S. Code of Business Conduct

7 Scope The Code governs the business conduct of every Novo Nordisk employee. This includes all home office and field employees, the Executive Team, and the U.S. Board of Directors. Everyone is expected to comply with the Code, federal healthcare programs and FDA requirements, and all Novo Nordisk policies and procedures. Novo Nordisk makes the promotion of, and adherence to, the Code of Conduct an element in evaluating the performance of all employees. When Novo Nordisk hires outside business partners, such as vendors, agencies, or other service providers, they must adhere to the Code, federal healthcare programs and FDA requirements, and all Novo Nordisk policies and procedures in all dealings on our behalf. The employee responsible for a project must ensure that such business partners are aware of these standards and laws. The Novo Nordisk Way The Novo Nordisk Way describes who we are, where we want to go, and the values that characterize our company. The Novo Nordisk Way connects our history and our future. It sets direction for and applies to all employees in Novo Nordisk no matter what you do or where you work. It is a promise we make to each other and our external stakeholders. Use the Novo Nordisk Way to guide the decisions you make and the actions you take. Make the Novo Nordisk Way your way. In 1923, our Danish founders began a journey to change diabetes. Today, we are thousands of employees across the world with the passion, the skills and the commitment to continue this journey to prevent, treat, and ultimately cure diabetes. Every day we must make difficult choices, always keeping in mind what is best for patients, our employees and our share- holders in the long run. It s the Novo Nordisk Way Our ambition is to strengthen our leadership in diabetes. We aspire to change possibilities in hemophilia and other serious chronic conditions where we can make a difference. Our key contribution is to discover and develop innovative biological medicines and make them accessible to patients throughout the world. Growing our business and delivering competitive financial results is what allows us to help patients live better lives, offer an attractive return to our shareholders, and contribute to our communities. Our business philosophy is one of balancing financial, social, and environmental considerations we call it The Triple Bottom Line. We are open and honest, ambitious and accountable, and treat everyone with respect. We offer opportunities for our people to realize their potential. We never compromise on quality and business ethics. Reference: The Novo Nordisk Way of Management ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 7

8 corporate compliance program Compliance Organization The Chief Compliance Officer oversees the Corporate Compliance Program. A compliance team assists in implementation of the Program. In addition, a group of Novo Nordisk Executive Team members, along with the Chief Compliance Officer, makes up the Compliance Committee, which supports the development, operation, and monitoring of the Corporate Compliance Program. The Chief Compliance Officer reports directly to the President of Novo Nordisk Inc. He has direct access to the Compliance Committee and the Board of Directors. The Chief Compliance Officer exercises independent judgment and has the authority to lead change in the organization regarding compliance activities. Program Objectives Novo Nordisk is committed to upholding the highest standards of business conduct and ethics. In all of its activities, Novo Nordisk seeks to promote the core principles of good citizenship and integrity. The objectives of our Compliance Program are: Support the development, review, implementation of, and adherence to the U.S. Code of Business Conduct and associated policies and procedures Support the development and implementation of effective education and training programs related to compliance Report on the status of compliance at Novo Nordisk to the Compliance Committee, President, and Board of Directors Maintain effective communication channels with each of the departments within Novo Nordisk Monitor and audit adherence to Novo Nordisk policies and procedures Investigate compliance issues and questions submitted to the Compliance Department Recommend appropriate corrective activities, which may include training, preventive measures, and, when appropriate, disciplinary action 8 Novo Nordisk Inc. U.S. Code of Business Conduct

9 Reporting Compliance Concerns Employees are encouraged to discuss any questions they may have regarding this Code of Conduct and/or any Company policies and procedures with their line manager. Everyone is required to report compliance issues, including suspected violations of this Code of Conduct, any federal healthcare program or FDA requirement, and/or any Company policies and procedures to the Compliance, Legal or Human Resources Department, or to line management. In addition, employees may make anonymous reports to the Novo Nordisk Compliance Incident Reporting Hotline via telephone or intranet. Managers or other departments who learn of compliance issues are required to immediately report such issues to the Contact the Compliance Department 24 hours a day, 7 days a week Compliance Incident Reporting Hotline (reports may be made anonymously) Phone: (888) Intranet: Compliance Helpline Phone: (609) NNIComplianceassist@novonordisk.com Compliance or Legal Department. In fact, being aware of wrongful conduct and not reporting it is a violation of company policy. Novo Nordisk will treat the information received in a confidential manner, to the extent possible. It is important to note that Novo Nordisk does not tolerate retaliation of any kind against employees who have reported a compliance concern or participated in a compliance-related investigation If I have a concern about an activity but am not sure whether it violates Company policy, what should I do? If possible, first discuss the issue with your line manager. If you do not feel your concern has been addressed or if you need further clarification, contact the Human Resources, Legal, or Compliance Department. What should I do if I am not comfortable reporting a compliance issue to my line manager because I am worried that submitting a complaint will affect my upcoming performance evaluation? Report the issue to the person responsible for the overall management of your department or division. You can also report it by calling the Incident Reporting Hotline, visiting the Incident Reporting Intranet Website, or contacting the Human Resources, Legal, or Compliance Department. Company policy prohibits retaliation for reporting a compliance concern. Reference: Anti-Retaliation ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 9

10 accountable We are accountable for our financial, environmental and social performance. innovation We provide innovation to the benefit of our stakeholders. the marketplace for more information Summary of Relevant Laws, Regulations, and Guidance Appendix A: Healthcare Laws, Regulations, and Guidance Healthcare Laws, Regulations, and Guidance The pharmaceutical industry is subject to an array of legal and ethical standards that govern the conduct of research, manufacturing, marketing, and promotion. Novo Nordisk has policies in place to ensure compliance with applicable laws and standards. for more information Contact Medical Information if you have questions about handling unsolicited requests for product information Intranet: MedOp/MedInfo/Pages/MedInfo.aspx Phone: To reach Medical Information by phone, contact Customer Care at (800) (select option #1, then option #4, and ask for Medical Information) Marketing of Our Products Our marketing and promotional activities must meet the highest ethical, medical, and scientific standards and present a balanced discussion of our products and services. To ensure compliance with the foregoing, all marketing and promotional materials are reviewed by the Medical, Regulatory, and Legal Departments. Employees are prohibited from proactively discussing information about unapproved new products or information that is not consistent with an approved product label. Requests for such information must be referred to the Medical Information Department or the appropriate field medical employee using the electronic product information request (epir) form in One Stop Shop (OSS) A healthcare professional that I call on has an urgent unsolicited question about an off-label use and has requested an immediate response. How should I respond? Because this is an urgent question, you should provide the healthcare professional with the Customer Care phone number (800) and instruct him/her to call to request the information directly. Customer Care will transfer the HCP to a medical information scientist who will promptly provide a verbal response to the healthcare professional s unsolicited question. References: Promotional Material Review Process ( Doc ). Business Ethics: Interactions with U.S. Healthcare Professionals and Healthcare Institutions ( Doc ). Unsolicited Requests for Medical Information ( Doc ). 10 Novo Nordisk Inc. U.S. Code of Business Conduct

11 for more information PhRMA Code on Interactions with Healthcare Professionals Intranet: novonordisk.com/services/legal/ pages/policiesprocedures.aspx Printed copy: contact the Compliance Department Interactions with Healthcare Professionals and Organizations As a pharmaceutical manufacturer, Novo Nordisk is subject to federal and state healthcare fraud and abuse laws. These laws prohibit giving or offering anything of value to influence prescribing or purchasing decisions. Additionally, they prohibit the submission of false claims or statements to federal or state healthcare programs. Healthcare professionals and healthcare organizations are also subject to laws and professional ethical standards when prescribing and making treatment decisions. Novo Nordisk has implemented written policies and procedures that provide guidance to employees on interacting appropriately with healthcare professionals and healthcare organizations Transparency Novo Nordisk is committed to compliance with the provisions of the Patient Protection and Affordable Care Act to report our financial relationships with healthcare professionals and institutions. We are striving to enhance the transparency of our interactions with healthcare professionals and institutions related to our payments, prescription drug samples, clinical trial support, and grants and charitable gifts that we provide to various organizations. What is the purpose of the PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code)? Does Novo Nordisk adhere to it? The PhRMA Code is intended to help ensure that our industry s sales and marketing practices adhere to high ethical standards and that companies are committed to marketing their products in a manner that benefits patients and enhances the practice of medicine. Novo Nordisk is a member of PhRMA and has committed to adhere to the PhRMA Code, which is integrated into our Company policies. References: Business Ethics: Interactions with U.S. Healthcare Professionals and Healthcare Institutions ( Doc ). Advisory Boards: Review and Implementation ( Doc ). Field Medical Employee and Field Sales Interactions ( Doc ). Field Medical Employee Conduct ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 11

12 Payments to Healthcare Professionals for Bona Fide Services Novo Nordisk may enter into contracts with healthcare professionals or other customers for services, such as research, marketing advisory services, or speaking engagements. Such arrangements are permissible provided they require the performance of genuine services for Novo Nordisk, compensation is consistent with fair market value and is not related to prescribing or purchasing volume or formulary treatment, and the services to be performed are documented in a written contract. The venue for meetings with consultants or speakers must be modest and conducive to the services provided Meals, Gifts, and Entertainment Employees are prohibited from giving, offering, or promising to give anything of value to influence the purchasing or prescribing of Novo Nordisk products or services. The only items that may be provided to healthcare professionals are those for the education of patients or healthcare professionals. Educational items must be of modest value, may only be given on an occasional basis, and must always be approved by the home office. Occasional meals may be provided in accordance with Company policy. Recreation and entertainment activities are prohibited for more information FFE Support & Samples Department Phone: (877) Intranet: novonordisk.com/sites/nnisample AccountabilityandCompliance/ default.aspx Product Samples Novo Nordisk has established sampling programs that provide drug samples and devices to licensed practitioners with practices encompassing the approved indication for the sampled drug through our sales representatives and direct-to-physician programs. Samples are not intended to be sold, purchased, and/or traded and should not be provided on the condition, or with a mutual understanding, that the customer will purchase, prescribe, or recommend Novo Nordisk products. Our FFE Support & Samples Department oversees the sampling process and has established policies and procedures to monitor compliance with the Prescription Drug Marketing Act (PDMA), state regulations, and Novo Nordisk policies and procedures. The Department strives to improve sample effectiveness through training programs, business processes, and management tools Where can I go to get clarification about educational items that may be appropriate to provide to healthcare professionals? Certain educational items are made available through the home office that may be distributed to healthcare professionals on an occasional basis. Consult the Business Ethics: Interactions with U.S. Healthcare Professionals policy for more information. References: Business Ethics: Interactions with U.S. Healthcare Professionals and Healthcare Institutions ( Doc ). Drug Sample Distribution ( Doc ). 12 Novo Nordisk Inc. U.S. Code of Business Conduct

13 Clinical Research The vision of our Clinical Trials Management team is to build a customerfocused culture of excellence, innovation, and collaboration where everyone is empowered and held accountable for managing clinical trials in support of the best therapeutic options for our patients. Novo Nordisk designs and conducts ethical clinical trials and provides diligent regulatory support for our products. We have developed policies and guidelines to comply with the applicable laws and regulations when conducting clinical research. Novo Nordisk publicly communicates all significant clinical research results in an accurate and balanced manner. Interactions with Patients Federal and state laws regulate the manner in which Novo Nordisk and those acting on behalf of the Company may interact with patients or use certain patient health information. Novo Nordisk has policies and procedures in place to ensure compliance with such laws Phone*: (Monday Friday; 8:30am 6pm EST) Customer Care: (800) (select appropriate option and ask for Product Safety) Rep Help Service Line: (field only) REP-7057 (select option #4) (24/7) Internal: NNI PS_NNI External: NNIPSNNI@novonordisk.com Fax: (24/7) (609) or (609) * After hours and weekend adverse events should be reported using either the or fax option. Product Safety and Adverse Event Reporting Novo Nordisk understands the importance of collecting safety information relating to its products and has policies and procedures in place to ensure that information is reported, documented, and handled in accordance with applicable laws and regulations. Employees are required to report product complaints or information from any source regarding an adverse event suffered by a patient who is currently using or who recently used a Novo Nordisk product to the Product Safety Group within 24 hours of receiving the information I learned of an adverse event experienced by a patient who is using one of our products. How do I make the report? If you learn of an adverse event, from any source, experienced by a patient using one of our products, you are required to transmit the report to the Product Safety Group using the contact information provided in the box above. References: Interactions with Patients in the Field ( Doc ). Internal Routing and Reporting of Customer Complaints and Adverse Events at Novo Nordisk ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 13

14 for more information Grants and Philanthropy Department Hotline: (866) Fax: (609) Internet: novonordiskgrants.com Community and Patient Health Education Grants Novo Nordisk may provide support for certain healthcare-related activities. Employees may never give, offer, or promise anything of value to anyone in order to influence purchasing, prescribing, or treatment decisions in favor of Novo Nordisk products. All healthcare-related funding requests must be referred to the Grants and Philanthropy Department. Employees are prohibited from promising grant funding. All decisions regarding grant funding will be made by the appropriate grants committee. Novo Nordisk has policies and procedures in place to ensure that our grant-making activities are in accordance with the federal and state laws designed to prevent healthcare fraud and abuse Grants for Third-Party Educational or Scientific Meetings Novo Nordisk may provide grant funding to support medical education meetings, seminars, and conferences designed to communicate the most current scientific information to healthcare professionals and to support independent scientific exchange. In accordance with Novo Nordisk policy, such programs remain independent and non-promotional in nature. Grants for Research Physicians or representatives of institutions sometimes request assistance from Novo Nordisk in the form of free products or funding for independent research. Even though these studies are not part of the Company s clinical program and Novo Nordisk is not the sponsor of these studies, we may decide to provide support for such studies. A doctor that I call on has asked me to request funding from Novo Nordisk for an educational grant. Am I allowed to complete the request? No. You should refer the doctor to the Novo Nordisk Grants Website at novonordiskgrants.com or the Grants Hotline at (866) References: Healthcare Professional Education Grants ( Doc ). Community and Patient Health Education Grants ( Doc ). 14 Novo Nordisk Inc. U.S. Code of Business Conduct

15 Antitrust Laws Antitrust laws are designed to ensure effective and open competition in the marketplace. Antitrust laws impact virtually every aspect of Novo Nordisk dealings: our relationships with suppliers, distributors, and other customers and, of course, our relationships with competitors. It is the policy of Novo Nordisk to make certain that our practices comply at all times with all applicable rules and regulations. This is critical to maintain the reputation of Novo Nordisk and to ensure that Novo Nordisk or its employees are not subjected to sanctions for antitrust law-related violations. Bribery Novo Nordisk employees may not offer, promise, give, or receive any bribe. A bribe is any item of value or advantage that is promised, offered, or given, directly or indirectly, to a government employee or agent in violation of any federal, state or local law or regulation (including the laws of U.S. commonwealths and territories). Facilitation payments minor payments made to a private or public official for the purpose of expediting or facilitating the performance of a routine action are also prohibited. As a general rule, because the relevant laws vary widely, any employee who is unsure whether or not an action may be a bribe should consult with their line manager or an attorney in the Legal Department. Fraud Novo Nordisk is committed to preventing and detecting fraud against the Company. Fraud involves deliberate and deceptive acts with the intention of obtaining an unauthorized benefit, such as money, property or services. Novo Nordisk employees are never allowed to use Company assets for personal gain. Forgery of Company documents is strictly forbidden What should I do if an employee of a competitor approaches me to discuss prices or market conditions? Such discussions should be avoided. You should inform the competitor s employee that you will not engage in any such discussions and promptly contact an attorney in the Legal Department who will assist you in taking any other steps that might be advisable to protect you and the Company. References: Business Ethics ( Doc ). Giving and Receiving Gratuities, Gifts, Entertainment and Other Things of Value: Bribery ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 15

16 stakeholders We provide innovation to the benefit of our stakeholders. respect We treat everyone with respect. our company and co-workers Equal Employment Opportunity and Anti-Harassment At Novo Nordisk, we are committed to providing a discrimination-free working environment for all applicants and employees. Our policies prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, marital or familial status, national origin or citizenship, ancestry, pregnancy, military service or affiliation, actual or perceived physical or mental disability, medical condition, genetic information, or any other basis protected under federal, state, or local law. Our policies also prohibit harassing conduct by any employee, including co-workers, managers, and officers, as well as by any person doing business with or for the Company, including outside vendors, business partners, customers, and service providers A co-worker has spoken to me in a way I believe is inappropriate, and it has made me uncomfortable. What should I do? You should promptly respond by politely but firmly confronting the individual and asking the person to stop the behavior immediately and by also reporting the behavior to: Your Human Resources business partner Human Resources: Employee Relations Department Human Resources: AskHR ( [external] or x5290 [internal]) Compliance Department (Chief Compliance Officer) Legal Department Your manager or your manager s manager Vice president of your department Reference: Equal Employment Opportunity (EEO) and Anti-Harassment ( Doc ). 16 Novo Nordisk Inc. U.S. Code of Business Conduct

17 development We focus on personal performance and development. healthy We have a healthy and engaging working environment. Anti-Retaliation Policy Novo Nordisk is committed to providing a workplace that is free from unlawful retaliation. We encourage employees to report concerns about discrimination, harassment, retaliation, fraud, violation of company policy, illegal activities, or other wrongdoing in the workplace, and to participate in investigations into such allegations, without fear of retaliation, reprisal, or other adverse consequences directly related to his or her reporting or participation. Open Door Policy At Novo Nordisk, we encourage an open door policy. This means that every manager s door is open to every employee. The purpose of an open door policy is to support open communication, feedback, and discussion about any matter. Employees are encouraged to provide feedback and ask questions about policies, procedures, and guidelines. Conflicts of Interest All Novo Nordisk business decisions should be based on and promote the best interests of the Company. A conflict of interest occurs when an employee has competing professional and personal interests that may impact the employee s ability to perform her job objectively and without bias. Employees must refrain from engaging in any action or relationship that creates a conflict of interest. Employees who have engaged in any action or relationship that creates an actual or potential conflict of interest must immediately report the issue to the attention of line management or the Human Resources Department. Failure to do so may result in disciplinary action What are examples of potential conflicts of interest? Examples of potential conflicts of interest include, but are not limited to: Contracts with a company controlled by an employee Employment with a second employer Decisions that will affect an employee s financial circumstances or those of a close relative Decisions that will otherwise affect the interests of an employee or close relative Loans or other benefits to an employee Employment of a close relative in the same department as a current employee Sexual or romantic relationships between managers and employees whom they directly or indirectly supervise References: Anti-Retaliation ( Doc ). Business Ethics ( Doc ). Employment of Relatives ( Doc ). Conflicts of Interest ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 17

18 Gratuities, Gifts, Entertainment, and Other Things of Value A gratuity is anything of monetary value given by an employee to a non-novo Nordisk business associate or received by an employee from a non-novo Nordisk business associate for personal use or enjoyment. Gratuities include, but are not limited to, cash, gifts, meals, and entertainment. Employees should avoid giving gifts that might be perceived to have undue influence on business decisions and should not accept any gratuity if doing so may influence business decisions Competitive Intelligence Collecting and analyzing publicly available business information is an important and valuable activity. However, employees shall not unlawfully use, seek to obtain, or acquire trade secrets and other confidential and proprietary information of other companies, including competitors and companies where employees may have previously been employed. Employees should not use information improperly obtained or disclose it to other employees, even if it is for the benefit of Novo Nordisk. Enforcement and Discipline Novo Nordisk will promptly investigate complaints and take appropriate corrective action in the event noncompliant conduct occurs. Failure to adhere to the U.S. Code of Business Conduct, applicable laws and regulations, and Company policies and procedures may result in disciplinary action, up to and including termination I have inadvertently come into possession of non-public competitor materials. What should I do with this information? You should forward the materials to the Legal Department immediately. You must not open, retain, or otherwise transfer confidential information from a competitor. The Legal Department will return the materials to the owner. References: Giving and Receiving Gratuities, Gifts, Entertainment and Other Things of Value: Bribery ( Doc ). Competitive Intelligence ( Doc ). Disciplinary/Termination ( Doc ). 18 Novo Nordisk Inc. U.S. Code of Business Conduct

19 Confidentiality, Privacy, and Security The Company s confidential information is important to Novo Nordisk. Every Novo Nordisk employee has access to confidential and proprietary information about Novo Nordisk and its affiliates. Examples of confidential or proprietary information include but are not limited to financial information, business and marketing plans, sales training materials, and product research and development. Employees are required to maintain the privacy of the Company s confidential and proprietary information. Insider Trading As an employee of Novo Nordisk, you may be exposed to inside information which has not yet been made available to the public. This information may include financial information, product information, or litigation. It is illegal to purchase or sell a security of any issuer on the basis of material, non-public information. If you have material, non-public information, you must refrain from trading Novo Nordisk A/S securities and refrain from passing the information to others who may wish to trade. When in doubt as to whether you should trade, you should seek guidance from the Novo Nordisk Legal Department. for more information Guidelines Related to Insiders and the Insider Registry Phone: Legal Department (609) (Novo Nordisk Main Number) Intranet: Legal/shares_governance/Trading_shares/ InsiderRegister/Pages/default.aspx What are examples of material, non-public information? Examples may include: Current information regarding U.S. sales revenue for a particular Novo Nordisk product which has not been released to the public Information regarding the initiation of a government investigation which has not been released to the public Information regarding the license of a late-stage development product which has not been released to the public Novo Nordisk Inc. U.S. Code of Business Conduct 19

20 Company Records and Document Retention Managing the documents we create has become more complex due to increased legal and regulatory requirements. Novo Nordisk has policies and procedures related to maintaining documentation and information and it is the responsibility of each employee to comply with these policies. for more information Documents and Records Management Phone: (609) (Novo Nordisk Main Number) Intranet: legal/nnidocumentmanagement/default.aspx for more information Intellectual Property Department Phone: (609) (Novo Nordisk Main Number) Intranet: Pages/LegalIntellectualCompliance.aspx/patent/patenthome.asp Intellectual Property To remain competitive in the marketplace, Novo Nordisk must protect its intellectual property. Intellectual property includes any invention, patent, trademark, copyright, and business and technical knowledge, including know-how and trade secrets. Additionally, it is critical that we respect the intellectual property rights of others. Novo Nordisk has policies in place to assist the Company whenever possible, to identify, acquire, and maintain the most valuable intellectual property rights possible in connection with our innovations and business opportunities, enable Novo Nordisk to use and enforce these intellectual property rights, and to protect us from risk of liability arising from infringement or misuse of thirdparty intellectual property rights. Employees must contact the Intellectual Property Department whenever they believe there is an opportunity or issue involving intellectual property rights. Furthermore, any business activity involving intellectual property rights belonging to either Novo Nordisk or others must be conducted with the approval of the Intellectual Property Department. What is a trade secret and how does it apply to me? A trade secret is confidential information that gives Novo Nordisk a competitive advantage or other actual or potential independent economic value. Trade secrets may include, but are not limited to, marketing strategies, forecasts, customer lists, and pricing information. Failure to protect Novo Nordisk trade secrets and other confidential information can result in serious consequences for everyone. Are patents limited to inventions that are only made in a laboratory? No. Patentable inventions can include nearly any process or product that is new, nonobvious, and useful. Patents may be granted for new ways of treating or diagnosing patients and even some business methods. References: Document and Record Retention at Novo Nordisk ( Doc ). Documents Catalogue for Regions and International Sites ( Doc ). 20 Novo Nordisk Inc. U.S. Code of Business Conduct

21 Information Technology Novo Nordisk makes available many technology resources to help employees do their jobs. These resources include , voice mail, desktop/laptop computers, fax machines, copiers, computer servers and networks, Internet and Intranet access, and other electronic devices and services. Access to Novo Nordisk information technology (IT) systems is a privilege given to each user for the express purpose of gathering business-related information and corresponding with customers, vendors, and other business associates. Novo Nordisk employees are required to adhere to our corporate information technology security policy, IT Security Procedure, and to the IT Corporate Code of Conduct as well as the computer, network, and usage requirements detailed in the Computer Systems Acceptable Use Policy and the Internet Posting By Employees Policy. Failure to adhere to these policies can result in loss of valuable proprietary or personal information as well as a compromise to the security or integrity of Novo Nordisk systems, networks, and data for more information Information Technology Service Desk (Technology Support) Phone: (609) (home office employees) (866) (field employees) IT Service Portal: services/it/pages/computersphonesitservice.aspx For questions related to Information Technology policies and procedures, contact an attorney in the Novo Nordisk Legal Department at (609) References: Computer Systems Acceptable Use Policy ( Doc ). Internet Posting By Employees ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 21

22 optimize We optimize the way we work and strive for simplicity. quality We never compromise on quality and business ethics. the public and the community Our Triple Bottom Line At Novo Nordisk, sustainable development has been an integral part of the way we do business for more than a decade. Our way of translating it into practice is the Triple Bottom Line. In all of our work, we strive to be economically viable, socially responsible, and environmentally sound. Balancing the Triple Bottom Line is about considering each of these elements when making business decisions. In this way, we not only manage a sound business, but we also demonstrate our commitment to driving sustainable development both locally and globally. 22 Novo Nordisk Inc. U.S. Code of Business Conduct

23 for more information Grants and Philanthropy Department Hotline: (866) novonordisk.com Fax: (609) Internet: novonordiskgrants.com Social Responsibility Novo Nordisk supports activities within our local communities through sponsorships and charitable contributions. Our Grants and Philanthropy Department provides charitable donations and funds for philanthropic programs that are consistent with the Novo Nordisk Triple Bottom Line values of being recognized as a socially responsible, good corporate citizen in the communities in which we work and live. Novo Nordisk employees spend many hours each year donating their time to organizations in support of our mission What should I do if an organization requests a charitable donation from Novo Nordisk? You should refer the organization to the Novo Nordisk Grants Website at novonordiskgrants.com or the Grants Hotline at (866) References: Charitable Gifts ( Doc ). Sponsorship ( Doc ). Corporate Giving at Novo Nordisk Inc. ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 23

24 Environment, Health, and Safety Novo Nordisk continuously strives to reduce its environmental impact and to create a safe and healthy working environment for all employees. Novo Nordisk has an environmental policy and an occupational health and safety policy to comply with environmental and safety laws and regulations. Both policies are part of the Novo Nordisk Way. We have also instituted programs to motivate and educate employees to be accountable in all matters regarding occupational health and safety. 24 Novo Nordisk Inc. U.S. Code of Business Conduct

25 External Communications with the Media and the Public Novo Nordisk is committed to providing the most accurate and dependable information to the media and to the public. To ensure that our message is both consistent and compliant with our policies and our legal obligations, employees are prohibited from making any comments to the media regarding Novo Nordisk unless expressly authorized to do so by the Communications and Public Affairs Department. If contacted, employees should politely decline and refer the journalist to the Media Hotline at (609) The Communications and Public Affairs Department will determine the appropriate response to the inquiry Interactions with Government Representatives and Investigators It is Novo Nordisk policy to fully cooperate with all valid requests for information from government entities. During any government inspection or investigation, employees should never destroy or alter any Novo Nordisk documents, lie, or make misleading statements to a government investigator, attempt to cause another employee to fail to provide accurate information, and/or obstruct, mislead, or delay the communication of information or records to any government entity. Novo Nordisk employees shall at all times observe the Company s high ethical standards when interacting with government entities for more information Novo Nordisk Media Hotline: (609) Communications and Public Affairs Department Intranet: aboutnni/commctr_pc/pages/newsfront.aspx What type of inquiries should be referred to the Communications and Public Affairs Department? Any inquiry from a newspaper, television, radio, magazine, Internet, or other medium should be submitted to Communications and Public Affairs. What should I do if I receive an inquiry from a government entity? These inquiries are often time sensitive. Explain that Novo Nordisk policy requires submission of all inquires of this type to the Legal Department. In order to ensure that Novo Nordisk handles such requests appropriately, you are required to immediately forward the information to your line manager and the Legal Department. Contact the home office at (609) and ask to speak to an attorney in the Legal Department. References: News Media Contact with Employees of Novo Nordisk ( Doc ). Government Entity Contact Policy ( Doc ). Novo Nordisk Inc. U.S. Code of Business Conduct 25

26 appendix A healthcare laws, regulations, and guidance Federal and State Healthcare Laws Law Anti-Kickback Laws (Federal and State) Description Anti-kickback laws prohibit anyone from offering, paying, soliciting, or receiving anything of value (including a kickback, bribe, or rebate) in return for referring an individual for an item or service reimbursed under a federal or state healthcare program. Violations of the laws can lead to severe penalties, including: criminal and/or civil fines for Novo Nordisk, individual employees, and the healthcare professionals (HCPs) involved in an improper arrangement, imprisonment of individuals, and possible exclusion of Novo Nordisk products from eligibility for reimbursement under Medicare and Medicaid. The False Claims Act The Foreign Corrupt Practices Act Medicaid Drug Rebate Statute Physician Payment Sunshine Provisions Federal and state laws prohibit the submission of false or fraudulent claims or information for payment or approval to the United States government and healthcare programs. These laws include providing false information to customers related to coding, pricing, or submission of claims for government programs and the promotion of products for unapproved uses. The Foreign Corrupt Practices Act prohibits corrupt payments to foreign officials for the purpose of obtaining or keeping business. The Medicaid Drug Rebate Statute allows for states to receive federal funding for outpatient drugs dispensed to Medicaid patients. To participate in the program, drug manufacturers enter into a rebate agreement with the Secretary of the Department of Health and Human Services. The drug rebate program is administered by the Centers for Medicare and Medicaid Services and Center for Medicaid and State Operations. The Physician Payment Sunshine Provisions of H.R were signed as federal law as part of the Patient Protection and Affordable Care Act (PPACA). The law requires pharmaceutical manufacturers to annually report and publicly disclose to the Department of Health and Human Services (DHHS) payments and other transfers of value provided to covered recipients. 26 Novo Nordisk Inc. U.S. Code of Business Conduct

27 Federal and State Healthcare Laws Law Prescription Drug Marketing Act Prescription Drug Sample Transparency Safe Harbors State Healthcare Professional Licensing Laws State Marketing and Advertising Laws Description The provision of samples to licensed prescribers is regulated by the U.S. Food and Drug Administration and codified in the Pharmaceutical Drug Marketing Act (PDMA). This act makes it unlawful for a pharmaceutical representative to provide samples to an unlicensed person and also sets standards for ensuring sample accountability. The Prescription Drug Sample Transparency Provisions of H.R were signed as federal law as part of the PPACA. The law requires pharmaceutical manufacturers and authorized distributors of applicable drugs to annually submit to DHHS the identity and quantity of drug samples requested, and the identity and quantity of drug samples distributed. The anti-kickback statute provides safe harbors as exceptions for payment and business practices that are implicated by law from criminal and civil prosecution under the statute. As outlined by the Department of Health and Human Services Office of the Inspector General (OIG), to be protected by a safe harbor, an arrangement must fit squarely in the safe harbor. State professional licensing laws provide for license revocation or other disciplinary action to be taken against an HCP who engages in unprofessional conduct, such as soliciting or receiving remuneration in return for referrals or for ordering or promoting products or conducting unnecessary medical procedures. Several states (including CA, DC, ME, MN, NV, VT, MA, WV) have enacted laws that require pharmaceutical manufacturers to annually disclose to state regulatory bodies marketing costs and financial expenditures to physicians, purchasers, and dispensers of prescription drugs. This information often includes the value, nature, and purpose of the payment. Novo Nordisk Inc. U.S. Code of Business Conduct 27

28 appendix A healthcare laws, regulations, and guidance cont. Regulatory and Industry Guidance Law Food and Drug Administration (FDA) Restrictions on Promotion OIG Compliance Program Guidance for Pharmaceutical Manufacturers PhRMA Code on Interactions with Healthcare Professionals Description The FDA regulates the labeling and advertising of Novo Nordisk products. A product s labeling includes all information on the drug package, the prescribing information, and any other written, printed, or graphic materials provided by Novo Nordisk about the product. All materials used to promote Novo Nordisk products, such as advertisements, brochures, and detail aids, must be consistent with the approved labeling. Promotional materials that are false, lacking fair balance, or otherwise misleading violate FDA rules. Guidelines provided by The Office of Inspector General (OIG) of the Department of Health and Human Services (DHHS) for pharmaceutical manufacturers to consider when developing, implementing, or evaluating a compliance program. The guidance is intended to assist with the development and implementation of internal controls and procedures that promote adherence to applicable statutes, regulations, and requirements of the federal healthcare programs. The Pharmaceutical Research and Manufacturers of America (PhRMA) has issued the PhRMA Code on Interactions with Healthcare Professionals (the PhRMA Code). This voluntary code for member companies focuses on interactions between pharmaceutical company representatives and healthcare professionals. The Code provides guidance on marketing medicines to healthcare professionals and developing relationships focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education. 28 Novo Nordisk Inc. U.S. Code of Business Conduct

29 appendix B contact information Communications and Public Affairs Department Media Hotline: (609) Intranet: CommCtr_PC/Pages/newsfront.aspx Compliance Inquiries Helpline: (609) NNI Compliance Assistance (internal address) NNIComplianceassist@novonordisk.com (external address) Intranet: legal/pages/legalintellectualcompliance.aspx Copy of the PhRMA Code on Interactions with Healthcare Professionals Intranet: legal/pages/policiesprocedures.aspx Printed copy: Contact the Compliance Department Documents and Records Management Phone: (609) (Novo Nordisk Main Number) Intranet: NNIDocumentManagement/default.aspx FFE Support & Samples Department Phone: (877) Intranet: NNISampleAccountabilityandCompliance/default.aspx Grants and Philanthropy Department Hotline: (866) GrantsOffice@novonordisk.com Fax: (609) Internet: novonordiskgrants.com Guidelines Related to Insiders and the Insider Registry (Legal Department) Phone: (609) (Novo Nordisk Main Number) Intranet: shares_governance/trading_shares/insiderregister/ Pages/default.aspx Human Resources Department Phone: (609) (Novo Nordisk Main Number) Information Technology Service Desk (Tech Support) Phone: (609) (home office employees) (866) (field employees) IT Service Portal: services/it/pages/computersphonesitservice.aspx Intellectual Property Department Phone: (609) (Novo Nordisk Main Number) Intranet: Pages/LegalIntellectualCompliance.aspx/patent/patenthome.aspx Legal Department Phone: (609) (Novo Nordisk Main Number) Medical Information and epir Questions Phone: Customer Care: (800) (select option #1, then option #4, and ask for Medical Information) Intranet: MedOp/MedInfo/Pages/MedInfo.aspx Report an Adverse Event Phone (M F 8:30am 6pm EST): Customer Care: (800) (select appropriate option and ask for Product Safety) Rep Help Service Line (field only): REP-7057 (option #4) (24/7): NNI PS_NNI (internal address) NNIPSNNI@novonordisk.com (external address) Fax (24/7): (609) or (609) Reporting Compliance Concerns Line Management: If possible, first consult your line manager Incident Reporting Hotline (Toll-Free 24/7): (888) (calls may be made anonymously) Incident Reporting Intranet Website (anonymous): NNIComplianceassist@novonordisk.com (external address) Novo Nordisk Inc. U.S. Code of Business Conduct 29

30 stakeholders respect healthy optimize quality