Code of Business Conduct and Ethics
Eagle Pharmaceuticals, Inc. (the “Company”) is committed to maintaining the highest standards of business conduct and ethics. This Code of Business Conduct and Ethics (the “Code”) reflects the business practices and principles of behavior that support this commitment. We expect every employee, officer and director to read and understand the Code and its application to the performance of his or her business responsibilities. References in the Code to employees are intended to cover officers and, as applicable, directors.
Officers, managers and other supervisors are expected to develop in employees a sense of commitment to the spirit, as well as the letter, of the Code. Supervisors are also expected to ensure that all agents and contractors conform to Code standards when working for or on behalf of the Company. The compliance environment within each supervisor’s assigned area of responsibility will be a factor in evaluating the quality of that individual’s performance. In addition, any employee who makes an exemplary effort to implement and uphold our legal and ethical standards may be recognized for that effort in his or her performance review. Nothing in the Code alters the at-will employment policy of the Company.
This Code cannot possibly describe every practice or principle related to honest and ethical conduct. The Code addresses conduct that is particularly important to proper dealings with the people and entities with whom we interact, but reflects only a part of our commitment. From time to time we may adopt additional policies and procedures with which our employees, officers and directors are expected to comply, if applicable to them. However, it is the responsibility of each employee to apply common sense, together with his or her own highest personal ethical standards, in making business decisions where there is no stated guideline in the Code. You can contact the Compliance Officer at 201-746-8207 for guidance in any situation.
Action by members of your family, significant others or other persons who live in your household (referred to in the Code as “family members”) also may potentially result in ethical issues to the extent that they involve the Company’s business. For example, acceptance of inappropriate gifts by a family member from one of our suppliers could create a conflict of interest and result in a Code violation attributable to you. Consequently, in complying with the Code, you should consider not only your own conduct, but also that of your family members, significant others and other persons who live in your household.
You should not hesitate to ask questions about whether any conduct may violate the Code, voice concerns or clarify gray areas. Section 3 below details the compliance resources available to you. In addition, you should be alert to possible violations of the Code by others and report suspected violations, without fear of any form of retaliation, as further described in Section 3. Violations of the Code will not be tolerated. Any employee who violates the standards in the Code may be subject to disciplinary action, which, depending on the nature of the violation and the history of the employee, may range from a warning or reprimand up to and including termination of employment and, in appropriate cases, civil legal action or referral for regulatory or criminal prosecution.
1. Honest and Ethical Conduct
It is the policy of the Company to promote high standards of integrity by conducting our affairs in an honest and ethical manner and in accordance with Eagle’s Vision, Values and Operating Principles. This includes all interactions with government agencies, health care professionals, customers, patients, clinical trial subjects, vendors and advocacy groups. The integrity and reputation of the Company depends on the honesty, fairness and integrity brought to the job by each person associated with us. Unyielding personal integrity is the foundation of corporate integrity.
At Eagle, we are committed to developing innovative drugs that result in meaningful improvements in patients’ lives. We will develop and commercialize our drugs with honor and integrity while acting in a socially responsible manner.
- Respect: Every person is entitled to dignity and respect. We will value the skills, work ethic and creativity of all our employees.
- Commitment: We will remain equally committed to our employees and to those people in need whose lives are enriched by our products.
- Teamwork: Success or failure belongs to all of us. We will prosper in the name of patient care because of the Genuity of our employees and the collective commitment of the Eagle Team.
- Honesty & Integrity: Our collaborative efforts will be marked by honesty and fair dealings. The integrity of our effort will be proven in both word and deed.
- Innovation: We are a company committed to continuous learning, and will endeavor to remain on the cutting edge of innovation. Our patients deserve nothing less.
- We simplify the complicated and we do not complicate the simple.
- We value, respect and trust our employees and peers.
- We are humbled and honored to serve our patients, customers, business partners, families, and community to advance the greater good.
- We value intellect, imagination, innovation, hard work, commitment and passion which lead to stakeholder value.
- We step out of the ordinary and rise to every occasion.
2. Legal Compliance
Obeying the law, both in letter and in spirit, is the foundation of this Code. Our success depends upon each employee operating within legal guidelines and cooperating with local, national and international authorities. We expect employees to understand the legal and regulatory requirements applicable to their business units and areas of responsibility. We hold or provide access to periodic training sessions or relevant education in order to ensure that all employees comply with the relevant laws, rules and regulations associated with their employment, including laws prohibiting insider trading (which are discussed in further detail in Section 4 below). While we do not expect you to memorize every detail of these laws, rules and regulations, we want you to be able to determine when to seek advice from others. If you do have a question in the area of legal compliance, it is important that you not hesitate to seek answers from your supervisor or the Compliance Officer.
Disregard of the law will not be tolerated. Violation of domestic or foreign laws, rules and regulations may subject an individual, as well as the Company, to civil and/or criminal penalties. You should be aware that conduct and records, including emails, are subject to internal and external audits, and to discovery by third parties in the event of a government investigation or civil litigation. It is in everyone’s best interests to know and comply with our legal and ethical obligations.
3. Compliance Standards and Procedures
The Company has established a Corporate Compliance Program to facilitate compliance with laws, relevant industry codes, this Code, and Company policies and procedures. The Company’s Corporate Compliance Program has been designed to incorporate the principles described in the OIG Compliance Program for Pharmaceutical Manufacturers (May 2003) and the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (2009) (PhRMA Code).
To facilitate compliance with this Code, we have implemented a program of Code awareness, training and review that is part of our broader compliance program overseen by our Compliance Committee. Consistent with the guidance contained in the OIG’s Compliance Program for Pharmaceutical Manufacturers, our Compliance Program consists of the following elements designed to ensure its effectiveness:
- Implementing written policies, procedures and standards of conduct;
- Designating a compliance officer and compliance committee;
- Conducting effective training and education;
- Developing effective lines of communication;
- Conducting internal monitoring and auditing;
- Enforcing standards through well-publicized disciplinary guidelines; and
- Responding promptly to detected offenses and undertaking corrective action.
We have established the position of Compliance Officer to oversee this program. The Compliance Officer is a person to whom you can address any questions or concerns related to this Code or any other matters relating to legal or regulatory compliance. The Compliance Officer can be reached at (201) 746-8207.
In addition to fielding questions or concerns with respect to potential violations of this Code or any other matters relating to legal or regulatory compliance, the Compliance Officer is responsible for:
- overseeing a comprehensive approach to establishing a culture of accountability and compliance within the Company;
- developing and managing the Compliance Department, including direct reports responsible for the following functions: training, policy, internal investigations, transparency, monitoring and auditing;
- implementing and overseeing the Compliance Program, including:
- setting the strategic direction for Eagle’s compliance activities and overseeing the execution of these efforts through an annual risk assessment and work plan
- directing and coordinating the development and implementation of compliance training
- overseeing and monitoring the Company’s adherence to the Compliance Program
- collaborating with other functional groups to develop controls, goals, and/or metrics that foster a culture of compliance by establishing accountability throughout each functional area
- determining appropriate and consistent disciplinary or corrective action in response to compliance issues
- regularly reviewing reports of new compliance developments throughout the industry;
- approving various internal and external certifications of compliance and transparency disclosure requirements as required by business practice, regulation, and/or law (e.g., state certifications, PhRMA Code, transparency postings, etc.); and
- providing regular updates to the Board of Directors and the Corporate Compliance & Ethics Committee.
Your most immediate resource for any matter related to the Code is your supervisor. He or she may have the information you need, or may be able to refer the question to another appropriate source. There may, however, be times when you prefer not to go to your supervisor. In these instances, you should feel free to discuss your concern with the Compliance Officer. If you are uncomfortable speaking with the Compliance Officer because he/she works in your department or is one of your supervisors, please contact the Chief Executive Officer. You also may report a matter anonymously to Eagle’s compliance hotline at 855-679-2699 (telephone), or by submitting a message through the Secure Web Form found at: http://www.openboard.info/EGRX/ (website).
Employees are required to conduct initial compliance training within thirty days of hire and within thirty days of a relevant change event (e.g., a new job function). Employees are also required to complete the Company’s annual compliance training requirements within the time period specified by the Company. All employees must receive a passing score on any associated training assessments conducted.
Clarifying Questions and Concerns; Reporting Possible Violations
If you encounter a situation or are considering a course of action and its appropriateness is unclear, discuss the matter promptly with your supervisor, the Compliance Officer or Eagle’s compliance hotline 855-679-2699 (telephone), or by submitting a message through the Secure Web Form found at: http://www.openboard.info/EGRX/ (website). Even the appearance of impropriety can be very damaging and should be avoided.
If you are aware of a suspected or actual violation of Code standards by others, you have a responsibility to report it. You are expected to promptly provide a compliance resource with a specific description of the violation that you believe has occurred, including any information you have about the persons involved and the time of the violation. The Company and applicable law prohibit any form of retaliation for raising concerns in good faith or for assisting in the investigation of misconduct. Whether you choose to speak with your supervisor or the Compliance Officer, or report your concern to Eagle’s compliance hotline, you should do so without fear of any form of retaliation. No director, officer or employee who, in good faith, raises a concern, or reports a violation or suspected violation, will be subject to harassment, retaliation or other adverse consequences. Eagle will take prompt disciplinary action against any director, officer or employee who retaliates against you, up to and including termination of employment.
Supervisors must promptly report any complaints or observations of Code violations to the Compliance Officer. If you believe your supervisor has not taken appropriate action, you should contact the Compliance Officer directly. The Compliance Officer will investigate all reported possible Code violations promptly and with the highest degree of confidentiality that is possible under the specific circumstances. Neither you nor your supervisor may conduct any preliminary investigation, unless authorized to do so by the Compliance Officer. Your cooperation in the investigation will be expected. As needed, the Compliance Officer will consult with Human Resources, Legal, outside legal counsel or consulting vendors, and/or the Compliance Committee. It is our policy to employ a fair process by which to determine violations of the Code.
All employees are required to fully cooperate with compliance investigations. Employees are expected to answer all questions honestly and with complete candor. Employees also are expected to be forthcoming with information related to the investigation. Making false statements or otherwise impeding an investigation will result in disciplinary action, up to and including termination of employment.
With respect to any complaints or observations of Code violations that relate to accounting, internal accounting controls or auditing concerns, the Compliance Officer shall promptly inform the chair of the Audit Committee, and the Audit Committee or such other persons as the Audit Committee determines to be appropriate under the circumstances shall be responsible for supervising and overseeing the inquiry and any investigation that is undertaken. In addition, any matters involving accounting, internal accounting controls and auditing concerns that are reported via the compliance hotline (855-679-2699 (telephone), or by submitting a message through the Secure Web Form found at: http://www.openboard.info/EGRX/ (website) shall be routed to both the Compliance Officer and the Audit Committee.
If any investigation indicates that a probable violation of the Code has occurred, we will take such action as we believe to be appropriate under the circumstances. If we determine that an employee is responsible for a Code violation, he or she will be subject to disciplinary action up to, and including, termination of employment and, in appropriate cases, civil legal action or referral for regulatory or criminal prosecution. Appropriate action may also be taken to deter any future Code violations.
4. Insider Trading
Employees who have access to confidential (or “inside”) information are not permitted to use or share that information for stock trading purposes or for any other purpose except to conduct our business. All non-public information about the Company or about companies with which we do business is considered confidential information. To use material non-public information in connection with buying or selling securities, including “tipping” others who might make an investment decision on the basis of this information, is not only unethical, it is illegal. Employees must exercise the utmost care when handling material inside information.
We have adopted a separate Insider Trading Policy with which you will be expected to comply as a condition of your employment with the Company. In addition, we have adopted a Window Period Policy that applies to our officers, directors and employees. You should consult our Insider Trading Policy and, if applicable, our Window Period Policy, for more specific information on the definition of “inside” information and on buying and selling our securities or securities of companies with which we do business.
5. Research and Development Compliance
The research and development of pharmaceutical products is subject to a number of legal and regulatory requirements, including standards related to ethical research procedures and proper scientific conduct. We expect employees to comply with all such requirements.
Patient Safety and Product Quality / Adverse Event Reporting
Patient health and safety is our top priority. All employees are responsible for the quality and safety of our products, regardless of the products’ stage in the product life cycle. This means complying with manufacturing quality regulations (such as FDA good manufacturing practice regulations in the U.S.), engaging in research and development activities in an ethical manner and applying the highest scientific standards. All data and other information regarding our products should be accurate and not misleading.
All employees, officers and directors must raise quality or safety questions or concerns, including reports of adverse events. This duty to report adverse events arises regardless of how, where or when you learned about the information. Adverse events must be reported immediately to: email@example.com. Product Quality complaints must be reported immediately to: firstname.lastname@example.org. Medical inquiries must be forwarded to: email@example.com.
Patient rights, safety and well-being are paramount. The Company complies with all laws and regulations related to the conduct of clinical trials and follows the principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. The Company also follows the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (2009) and the Principles for Responsible Clinical Trial Data Sharing (2013).
Transparency of Clinical Trial Data
The Company discloses and communicates its scientific data and results in a timely and accurate manner. This includes listing clinical trial protocols, as applicable, on the www.ClinicalTrials.gov website. The Company reviews and verifies data from all study sites to ensure the accuracy and integrity of the data that is reported.
Privacy of Patient Information
The Company is committed to respecting the privacy of patients that participate in clinical trials for our products. When legitimate activities related to the clinical trial require collecting, reviewing or using this personal information, care will be taken to prevent inappropriate use or release of this information.
6. Good Promotional Practices
Our products and activities are heavily regulated by the U.S. government and authorities globally. All employees must comply with the laws and regulations applicable to the health care and pharmaceutical industries including, but not limited to, the Federal Food, Drug, and Cosmetic Act; the Anti-Kickback Statute; the Stark laws; the False Claims Act; the Health Insurance Portability and Accountability Act and similar state laws. Violations of these laws and their implementing regulations can be the subject of very serious criminal and civil sanctions against the company and the individuals involved. Employees should seek guidance from Legal or Compliance regarding these laws and regulations.
Off-Label Promotion Prohibited
No employee may promote a product in a manner that is inconsistent with that product’s FDA-approved labeling. All information and materials used in the promotion of products must be pre-approved for such use by the company’s Medical, Legal and Regulatory Committee (MLR). Employees may not create their own promotional materials or change, alter or modify materials that have been approved by the company. All information presented in the promotion of our products must be truthful, accurate, supported by scientific data, and fair-balanced. No product may be promoted prior to its approval by relevant regulatory authorities.
7. Interacting with Health Care Professionals
Strict laws and regulations govern our interactions with health care professionals, which include physicians, nurses, hospital or medical office staff, and anyone involved in prescribing, administering, purchasing or recommending our products. We must ensure compliance with these rules and never interfere with a health care professional’s independent medical judgment. In the U.S., the Anti-Kickback Statute (and similar state laws) prohibit offering or providing anything of value to induce someone to prescribe, furnish, or recommend a product reimbursed by a federal health care program, such as Medicare or Medicaid. Certain arrangements involving the exchange of value with health care professionals, such as carefully-designed consulting or other personal services agreements, can be appropriate under the law. No employee may provide a health care professional with anything of value including, but not limited to, a gift, grant, consulting arrangement, speaking engagement, clinical study support, meals, entertainment, or cash or cash-equivalents, or payment of any kind, unless consistent with a written company policy governing the particular situation or prior approval from Legal or Compliance. Certain state laws also prohibit these items.
The Company is committed to compliance with all state, federal and international laws and regulations and industry standards regarding transparency related to our interactions with health care professionals. This includes the disclosure of payments, gifts, meals and other transfers of value provided to health care professionals. All employees, officers and directors are expected to comply with Company policies and procedures to ensure that all information that must be reported by the Company in connection with these transparency laws is captured accurately and completely.
8. Health Care Debarment and Exclusion
The Company is required to ensure that it does not work with individuals or companies that have been debarred by the FDA, excluded from participating in federal health care programs or otherwise are ineligible to contract with government agencies. All employees, officers and directors must certify at the time of employment and annually thereafter that they have not been debarred or excluded, or been convicted of a crime that may lead to debarment or exclusion.
9. International Business Laws
Our employees are expected to comply with the applicable laws in all countries to which they travel, in which they operate and where we otherwise do business, including laws prohibiting bribery, corruption or the conduct of business with specified individuals, companies or countries. The fact that in some countries certain laws are not enforced or that violation of those laws is not subject to public criticism will not be accepted as an excuse for noncompliance. In addition, we expect employees to comply with U.S. laws, rules and regulations governing the conduct of business by its citizens and corporations outside the U.S.
These U.S. laws, rules and regulations, which extend to all our activities outside the U.S., include:
- The Foreign Corrupt Practices Act, which prohibits directly or indirectly giving anything of value to a government official to obtain or retain business or favorable treatment, and requires the maintenance of accurate books of account, with all company transactions being properly recorded;
- U.S. Embargoes, which generally prohibit U.S. companies, their subsidiaries and their employees from doing business with, or traveling to, certain countries subject to sanctions imposed by the U.S. government (currently, Cuba, Iran, North Korea, Sudan and Syria), as well as specific companies and individuals identified on lists published by the U.S. Treasury Department;
- U.S. Export Controls, which restrict exports from the U.S. and re-exports from other countries of goods, software and technology to many countries, and prohibit transfers of U.S.-origin items to denied persons and entities; and
- Antiboycott Regulations, which prohibit U.S. companies from taking any action that has the effect of furthering or supporting a restrictive trade practice or boycott imposed by a foreign country against a country friendly to the U.S. or against any U.S. person.
If you have a question as to whether an activity is restricted or prohibited, seek assistance before taking any action, including giving any verbal assurances that might be regulated by international laws.
Antitrust laws are designed to protect the competitive process. These laws are based on the premise that the public interest is best served by vigorous competition and will suffer from illegal agreements or collusion among competitors. Antitrust laws generally prohibit:
- agreements, formal or informal, with competitors that harm competition or customers, including price fixing and allocations of customers, territories or contracts;
- agreements, formal or informal, that establish or fix the price at which a customer may resell a product; and
- the acquisition or maintenance of a monopoly or attempted monopoly through anti-competitive conduct.
- Certain kinds of information, such as pricing, production and inventory, should not be exchanged with competitors, regardless of how innocent or casual the exchange may be and regardless of the setting, whether business or social.
Antitrust laws impose severe penalties for certain types of violations, including criminal penalties and potential fines and damages of millions of dollars, which may be tripled under certain circumstances. Understanding the requirements of antitrust and unfair competition laws of the various jurisdictions where we do business can be difficult, and you are urged to seek assistance from your supervisor or the Compliance Officer whenever you have a question relating to these laws.
11. Environmental Compliance
Federal law imposes criminal liability on any person or company that contaminates the environment with any hazardous substance that could cause injury to the community or environment. Violation of environmental laws can involve monetary fines and imprisonment. We expect employees to comply with all applicable environmental laws.
It is our policy to conduct our business in an environmentally responsible way that minimizes environmental impacts. We are committed to minimizing and, if practicable, eliminating the use of any substance or material that may cause environmental damage, reducing waste generation and disposing of all waste through safe and responsible methods, minimizing environmental risks by employing safe technologies and operating procedures, and being prepared to respond appropriately to accidents and emergencies.
We respect the rights of our employees to manage their personal affairs and investments and do not wish to impinge on their personal lives. At the same time, employees should avoid conflicts of interest that occur when their personal interests may interfere in any way with the performance of their duties or the best interests of the Company. A conflicting personal interest could result from an expectation of personal gain now or in the future or from a need to satisfy a prior or concurrent personal obligation. We expect our employees to be free from influences that conflict with the best interests of the Company or might deprive the Company of their undivided loyalty in business dealings. Even the appearance of a conflict of interest where none actually exists can be damaging and should be avoided. Whether or not a conflict of interest exists or will exist can be unclear. Conflicts of interest are prohibited unless specifically authorized as described below.
If you have any questions about a potential conflict or if you become aware of an actual or potential conflict, and you are not an officer or director of the Company, you must discuss the matter with your supervisor or the Compliance Officer (as further described in Section 3). Supervisors may not authorize conflict of interest matters or make determinations as to whether a problematic conflict of interest exists without first seeking the approval of the Compliance Officer and providing the Compliance Officer with a written description of the activity. If the supervisor is involved in the potential or actual conflict, you should discuss the matter directly with the Compliance Officer. Officers and directors must seek any authorizations and determinations from the Compliance Committee, depending on the nature of the conflict of interest.
Factors that may be considered in evaluating a potential conflict of interest are, among others:
- whether it may interfere with the employee’s job performance, responsibilities or morale;
- whether the employee has access to confidential information;
- whether it may interfere with the job performance, responsibilities or morale of others within the organization;
- any potential adverse or beneficial impact on our business;
- any potential adverse or beneficial impact on our relationships with our customers or suppliers or other service providers;
- whether it would enhance or support a competitor’s position;
- the extent to which it would result in financial or other benefit (direct or indirect) to the employee;
- the extent to which it would result in financial or other benefit (direct or indirect) to one of our customers, suppliers or other service providers or others who may use our products (e.g., physicians); and
- the extent to which it would appear improper to an outside observer.
Although no list can include every possible situation in which a conflict of interest could arise, the following are examples of situations that may, depending on the facts and circumstances, involve problematic conflicts of interests:
- Employment by (including consulting for) or service on the board of a competitor, customer or supplier or other service provider. Activity that enhances or supports the position of a competitor to the detriment of the Company is prohibited, including employment by or service on the board of a competitor. Employment by or service on the board of a customer or supplier or other service provider is generally discouraged and you must seek authorization in advance if you plan to take such a position.
- Owning, directly or indirectly, a significant financial interest in any entity that does business, seeks to do business or competes with us.In addition to the factors described above, persons evaluating ownership in other entities for conflicts of interest will consider the size and nature of the investment; the nature of the relationship between the other entity and the Company; the employee’s access to confidential information; and the employee’s ability to influence the Company’s decisions. If you would like to acquire a financial interest of that kind, you must seek approval in advance.
- Soliciting or accepting gifts, favors, loans or preferential treatment from any person or entity that does business or seeks to do business with us. See Section 16 for further discussion of the issues involved in this type of conflict.
- Soliciting contributions to any charity or for any political candidate from any person or entity that does business or seeks to do business with us.
- Taking personal advantage of corporate opportunities. See Section 13 for further discussion of the issues involved in this type of conflict.
- Conducting our business transactions with your family member or a business in which you have a significant financial interest.Related-person transactions covered by our Related-Person Transactions Policy must be reviewed in accordance with such policy and will be publicly disclosed to the extent required by applicable laws and regulations.
- Exercising supervisory or other authority on behalf of the Company over a co-worker who is also a family member. The employee’s supervisor and/or the Compliance Officer will consult with Human Resources to assess the advisability of reassignment.
- Loans to, or guarantees of obligations of, employees or their family members by the Company could constitute an improper personal benefit to the recipients of these loans or guarantees, depending on the facts and circumstances. Some loans are expressly prohibited by law, and applicable law requires that our Board of Directors approve all loans and guarantees to employees. As a result, all loans and guarantees by the Company must be approved in advance by the Board of Directors or the Audit Committee.
12. Corporate Opportunities
You may not take personal advantage of opportunities for the Company that are presented to you or discovered by you as a result of your position with us or through your use of corporate property or information, unless authorized by your supervisor, the Compliance Officer or the Audit Committee, as described in Section 3. Even opportunities that are acquired privately by you may be questionable if they are related to our existing or proposed lines of business.
Participation in an investment or outside business opportunity that is directly related to our lines of business must be pre-approved. You may not use your position with us or corporate property or information for improper personal gain, nor should you compete with us in any way.
13. Maintenance of Corporate Books, Records, Documents and Accounts; Financial Integrity; Public Reporting
The integrity of our records and public disclosure depends upon the validity, accuracy and completeness of the information supporting the entries to our books of account. Therefore, our corporate and business records should be completed accurately and honestly. The making of false or misleading entries, whether they relate to financial results or test results, is strictly prohibited. Our records serve as a basis for managing our business and are important in meeting our obligations to customers, suppliers, creditors, employees and others with whom we do business. As a result, it is important that our books, records and accounts accurately and fairly reflect, in reasonable detail, our assets, liabilities, revenues, costs and expenses, as well as all transactions and changes in assets and liabilities. We require that:
- no entry be made in our books and records that intentionally hides or disguises the nature of any transaction or of any of our liabilities, or misclassifies any transactions as to accounts or accounting periods;
- transactions be supported by appropriate documentation;
- the terms of sales and other commercial transactions be reflected accurately in the documentation for those transactions and all such documentation be reflected accurately in our books and records;
- employees comply with our system of internal controls; and
- no cash or other assets be maintained for any purpose in any unrecorded or “off-the-books” fund.
Our accounting records are also relied upon to produce reports for our management, stockholders and creditors, as well as governmental agencies. In particular, we rely upon our accounting and other business and corporate records in preparing periodic and current reports that we file with the Securities and Exchange Commission (“SEC”). Securities laws require that these reports provide full, fair, accurate, timely and understandable disclosure and fairly present our financial condition and results of operations. Employees who collect, provide or analyze information for or otherwise contribute in any way in preparing or verifying these reports should strive to ensure that our financial disclosure is accurate and transparent and that our reports contain all of the information about the Company that would be important to enable stockholders and potential investors to assess the soundness and risks of our business and finances and the quality and integrity of our accounting and disclosures.
- no employee may take or authorize any action that would intentionally cause our financial records or financial disclosure to fail to comply with generally accepted accounting principles, the rules and regulations of the SEC or other applicable laws, rules and regulations;
- all employees must cooperate fully with our Accounting Department, as well as our independent public accountants and counsel, respond to their questions with candor and provide them with complete and accurate information to help ensure that our books and records, as well as our reports filed with the SEC, are accurate and complete; and
- no employee should knowingly make (or cause or encourage any other person to make) any false or misleading statement in any of our reports filed with the SEC or knowingly omit (or cause or encourage any other person to omit) any information necessary to make the disclosure in any of our reports accurate in all material respects.
Any employee who becomes aware of any departure from these standards has a responsibility to report his or her knowledge promptly to a supervisor, the Compliance Officer, the Audit Committee, or one of the other compliance resources described in Section 3.
14. Fair Dealing
We strive to outperform our competition fairly and honestly through superior performance and not through unethical or illegal business practices. Acquiring proprietary information from others through improper means, possessing trade secret information that was improperly obtained, or inducing improper disclosure of confidential information from past or present employees of other companies is prohibited, even if motivated by an intention to advance our interests. If information is obtained by mistake that may constitute a trade secret or other confidential information of another business, or if you have any questions about the legality of proposed information gathering, you must consult your supervisor or the Compliance Officer, as further described in Section 3.
You are expected to deal fairly with our suppliers, employees and anyone else with whom you have contact in the course of performing your job. Be aware that the Federal Trade Commission Act provides that “unfair methods of competition in commerce, and unfair or deceptive acts or practices in commerce, are declared unlawful.” It is a violation of the Federal Trade Commission Act to engage in deceptive, unfair or unethical practices, and to make misrepresentations in connection with sales activities.
Employees involved in procurement have a special responsibility to adhere to principles of fair competition in the purchase of products and services by selecting suppliers based exclusively on normal commercial considerations, such as quality, cost, availability, service and reputation, and not on the receipt of special favors.
15. Gifts and Entertainment
Business gifts and entertainment are meant to create goodwill and sound working relationships and not to gain improper advantage with current or potential suppliers, vendors or partners or facilitate approvals from government officials. Unless express permission is received from a supervisor, the Compliance Officer or the Audit Committee, gifts and entertainment cannot be offered, provided or accepted by any employee.
Unless consistent with customary business practices and not excessive in value.However, separate, more restrictive guidelines apply to interactions with healthcare professionals (see the Gifts, Meals, Entertainment & State Law Compliance Policy). This principle applies to our transactions everywhere in the world, even where the practice is widely considered “a way of doing business.” Employees should not accept gifts or entertainment that may reasonably be deemed to affect their judgment or actions in the performance of their duties. Our customers, suppliers and the public at large should know that our employees’ judgment is not for sale.
Under some statutes, such as the U.S. Foreign Corrupt Practices Act (further described above in Section 9), giving anything of value to a government official to obtain or retain business or favorable treatment is a criminal act subject to prosecution and conviction. Discuss with your supervisor or the Compliance Officer any proposed entertainment or gifts if you are uncertain about their appropriateness.
16. Protection and Proper Use of Company Assets
All employees are expected to protect our assets and ensure their efficient use. Theft, carelessness and waste have a direct impact on our financial condition and results of operations. Our property, such as office supplies, computer equipment, products, laboratory supplies, and office or laboratory space are expected to be used only for legitimate business purposes, although incidental personal use may be permitted.You may not, however, use our corporate name, any brand name or trademark owned or associated with the Company or any letterhead stationery for any personal purpose.
You may not, while acting on behalf of the Company or while using our computing or communications equipment or facilities, either:
- access the internal computer system (also known as “hacking”) or other resource of another entity without express written authorization from the entity responsible for operating that resource; or
- commit any unlawful or illegal act, including harassment, libel, fraud, sending of unsolicited commercial email (also known as “spam”) in violation of applicable law, trafficking in contraband of any kind, or espionage.
If you receive authorization to access another entity’s internal computer system or other resource, you must make a permanent record of that authorization so that it may be retrieved for future reference, and you may not exceed the scope of that authorization.
Unsolicited commercial email is regulated by law in a number of jurisdictions. If you intend to send unsolicited commercial email to persons outside of the Company, either while acting on our behalf or using our computing or communications equipment or facilities, you should contact your supervisor or the Compliance Officer for approval.
All data residing on or transmitted through our computing and communications facilities, including email and word processing documents, is the property of the Company and subject to inspection, retention and review by the Company, with or without an employee’s or third party’s knowledge, consent or approval, in accordance with applicable law. Any misuse or suspected misuse of our assets must be immediately reported to your supervisor or the Compliance Officer.
One of our most important assets is our confidential information. As an employee of the Company, you may learn of information about the Company that is confidential and proprietary. You also may learn of information before that information is released to the general public. Employees who have received or have access to confidential information should take care to keep this information confidential. Confidential information includes non-public information that might be of use to competitors or harmful to the Company or its suppliers, vendors or partners if disclosed, such as business, marketing and service plans, financial information, product development, scientific data, manufacturing, laboratory results, designs, databases, customer lists, pricing strategies, personnel data, personally identifiable information pertaining to our employees, patients or other individuals (including, for example, names, addresses, telephone numbers and social security numbers), and similar types of information provided to us by our customers, suppliers and partners. This information may be protected by patent, trademark, copyright and trade secret laws.
In addition, because we interact with other companies and organizations, there may be times when you learn confidential information about other companies before that information has been made available to the public. You must treat this information in the same manner as you are required to treat our confidential and proprietary information. There may even be times when you must treat as confidential the fact that we have an interest in, or are involved with, another company.
You are expected to keep confidential and proprietary information confidential unless and until that information is released to the public through approved channels (usually through a press release, an SEC filing or a formal communication from a member of senior management, as further described in Section 19. Every employee has a duty to refrain from disclosing to any person confidential or proprietary information about us or any other company learned in the course of employment here, until that information is disclosed to the public through approved channels. This policy requires you to refrain from discussing confidential or proprietary information with outsiders and even with other Company employees, unless those fellow employees have a legitimate need to know the information in order to perform their job duties. Unauthorized use or distribution of this information could also be illegal and result in civil liability and/or criminal penalties.
You should also take care not to inadvertently disclose confidential information. Materials that contain confidential information, such as memos, notebooks, computer disks and laptop computers, should be stored securely. Unauthorized posting or discussion of any information concerning our business, information or prospects on the Internet is prohibited. You may not discuss our business, information or prospects in any “chat room,” regardless of whether you use your own name or a pseudonym. Be cautious when discussing sensitive information in public places like elevators, airports, restaurants and “quasi-public” areas within the Company or in and around the Company’s facilities. All Company emails, voicemails and other communications are presumed confidential and should not be forwarded or otherwise disseminated outside of the Company, except where required for legitimate business purposes.
18. Media/Public Discussions
It is our policy to disclose material information concerning the Company to the public only through specific limited channels to avoid inappropriate publicity and to ensure that all those with an interest in the Company will have equal access to information. All inquiries or calls from the press and financial analysts should be referred to our Chief Executive Officer. We have designated our Chief Executive Officer as our official spokesperson for questions concerning the financial performance, strategic direction or operating performance of the Company, and operational issues such a research and development, regulatory developments, sales and marketing, etc. Unless a specific exception has been made by the Chief Executive Officer, he or she is the only person who may communicate with the press on behalf of the Company. You also may not provide any information to the media about us off the record, for background, confidentially or secretly, including, without limitation, by way of postings on internet websites, chat rooms or “blogs”.
Any waiver of this Code for executive officers (including, where required by applicable laws, our principal executive officer, principal financial officer, principal accounting officer or controller (or persons performing similar functions)) or directors may be authorized only by our Board of Directors or, to the extent permitted by the rules of The NASDAQ Stock Market, a committee of the Board and will be disclosed as required by applicable laws, rules and regulations.