October 2003
[COMPANY NAME]
Code of Conduct
1. Who is responsible for the Company’s reputation and business ethics?
ALL of us are responsible for the Company’s reputation. One single employee’s act can have a very damaging effect on our reputation.
The Company’s reputation is based on our individual business conduct. Every interaction, both inside and outside the Company, is an opportunity for us to demonstrate our integrity. Ethical business conduct is a part of everyone’s job. We do not change our standards because competitors, suppliers, or customers behave differently, or in order to meet financial goals.
Each employee, officer, and director is responsible for the integrity of his or her own work. This Code of Conduct outlines the Company’s expected behaviors and practices. If we fail to comply with the Code, we risk being disciplined or terminated, and if we have broken a law, we may also be personally liable for that violation.
Initially, all employees, officers, and directors will be provided a copy of the Code Of Conduct, and will be asked to confirm that they have read and understand it. Subsequently, all new employees, officers and directors will be required to do the same. Following the initial provision and understanding of the Code, all employees, officers, and directors will be provided with all revisions to the Code and will be required to affirm their compliance with the code annually. This affirmation will be obtained from a simple form such as the one provided along with the code.
Each manager is responsible for ensuring that their employees understand and comply with the Code, for discussing business practice situations with their employees, and for responding promptly to concerns raised by any employee. Managers and supervisors are responsible for their employees’ actions, and are subject to discipline or dismissal if they participate in, direct, or approve an employee’s improper actions, or are or become aware of such actions and do not act appropriately to correct them.
We all are also individually responsible for reporting wrongdoing. If a Standard or law has been broken, report it promptly to your supervisor or manager, or another appropriate Company representative as described below.
2. What should you do if you have a concern about business practices and the Code?
All employees, officers or directors should report any violation or suspected violation of this Code to the appropriate Company personnel.
The Company’s efforts to ensure observance of, and adherence to, the goals and policies outlined in this Code mandate that employees, officers, and directors bring any instance, occurrence or practice that they, in good faith, believe is inconsistent with or in violation of this Code to the attention of their supervisors, managers, or other appropriate personnel. The following is an approach to dealing with potential problem situations. At all times maintain a professional demeanor when dealing with such situations.
3. Compliance with Laws, Rules and Regulations
The Company seeks to comply with both the letter and spirit of all applicable laws and regulations in all countries in which it operates.
The Company is committed to full compliance with the laws of the cities,
states and countries in which it operates. This includes, for example, those
relating to antitrust and promoting fair competition, preventing bribery,
illicit payments and corruption, insider trading , and labor practices, among
others. When faced with situations that require some knowledge of the law,
employees should seek advice from supervisors, managers, or other appropriate
personnel.
4. Corporate Opportunities
Employees, officers, and directors owe a duty to the Company to advance its
legitimate interests when the opportunity to do so arises.
Examples of prohibited conduct by employees with respect to corporate opportunities
include, but are not limited to:
If an employee has any doubt concerning his or her obligations with respect to any opportunity that presents itself to the employee, the employee should seek advice from supervisors, managers or other appropriate personnel.
5. Fair Dealing
Our goal is to be regarded as a company that does business with integrity.
Each employee, officer, and director should endeavor to deal fairly with the Company’s customers, suppliers, competitors, and employees. Under federal and state laws, the Company is prohibited from engaging in unfair methods of competition, and unfair or deceptive acts and practices. No employee should take unfair advantage of anyone through manipulation, concealment, abuse of confidential information, misrepresentation of material facts, or any other unfair-dealing practice.
Examples of prohibited conduct include, but are not limited to:
A. Bribery or payments:
C. Acquiring a competitor's trade secrets through bribery or theft;
D. Making false, deceptive or disparaging claims or comparisons about competitors or their products or services;
E. Mislabeling products or services; or
F. Making affirmative claims about the Company’s products and services without having a reasonable basis for doing so.
In addition, any public statements by or on behalf of the Company should always be accurate and have a reasonable basis in fact. Public statements may include such things as advertising, promotional activities and sales presentations.
6. Compliance with Accounting and Disclosure Control Policy
Our goal is to maintain accurate financial reports, and to keep our investors informed about the Company.
All employees and officers shall abide by all Accounting and Disclosure Controls set forth in the policy. This policy is formulated to ensure that all financial data is properly gathered, tabulated and reported in the Company’s records and that information from all areas of the Company that might be of interest to investors is forwarded to management for consideration for inclusion in public disclosure. A standing Disclosure Committee is established, consisting of officers and department heads, to review the Company’s proposed disclosure, and make any additions or modifications that each member deems to be of such potential interest. The members also certify their submissions.
7. Insider Trading
Employees, officers, and directors should never trade securities on the basis of confidential information acquired through their employment relationship.
Federal law and Company policy prohibit employees, officers, and directors, directly or indirectly, from purchasing or selling Company stock through the use of confidential information concerning the Company. All non-public information about the Company should be considered confidential information. No employee, officer, or director should buy or sell “options” in Company stock.
This same prohibition applies to trading in the stock of other publicly held companies, such as existing or potential customers or suppliers, on the basis of confidential information. The “tipping” of others who might make an investment decision on the basis of this information is also illegal.
If you have a question concerning appropriateness or legality of a particular securities transaction, it is imperative that you consult with the Company’s Chief Financial Officer.
8. Conflicts of Interest
An employee, officer, or director should avoid any situation in which his or her personal interests conflict or might appear to conflict with the Company’s interests.
Employees, officers, and directors should avoid entering into situations in which their personal, family or financial interests may conflict with those of the Company, unless the potential conflict situation is reviewed and expressly approved in writing, in advance, by the Board of Directors. The following are examples of potential conflicts:
Directors shall disclose to the Compliance Officer and the Chairman of the Corporate Governance and Nominating Committee any business relationship with any competitor, customer, or supplier of the company, or any other potential conflict of interest.
Conflicts are not always clear-cut. If an employee, officer, or director becomes aware of a conflict, potential conflict, or has a question as to a potential conflict, the employee, officer, or director should consult with higher levels of management or the Company’s Chief Financial Officer and/or follow the procedures described in Section 17 of the Code. If an employee becomes involved in a situation that gives rise to an actual conflict, the employee must inform higher levels of management and the Company’s Chief Financial Officer of the conflict.
9. Confidentiality
All confidential information concerning the Company obtained by employees, officers, and directors is the property of the Company and must be protected.
Confidential information includes all non-public information that might be of use to competitors, or harmful to the Company, its customers, or its suppliers, if disclosed. Employees, officers, and directors must maintain the confidentiality of such information entrusted to them by the Company, its customers and its suppliers, except when the Company authorizes disclosure or when required by law. The obligation to keep this information confidential applies even to communications with family members.
Examples of confidential information include, but are not limited to: the Company’s trade secrets; business trends and projections; information about financial performance; new product or marketing plans; research and development ideas or information; manufacturing processes; information about potential acquisitions, divestitures and investments; stock splits, public or private securities offerings or changes in dividend policies or amounts; and existing or potential major contracts, orders, suppliers, customers or finance sources or the loss thereof.
The obligations of employees, officers and directors with respect to confidential information of the Company continue even after their employment relationship with the Company terminates.
10. Protection and Proper Use of Company Assets
All employees, officers, and directors should protect the Company’s assets and ensure their proper use.
Company assets are to be used only for legitimate business purposes of the Company and only by authorized employees or their designees. This includes both tangible and intangible assets. Intangible assets include, but are not limited to: intellectual property such as trade secrets, patents, trademarks and copyrights; business, marketing and service plans; engineering and manufacturing ideas; designs; databases; Company records; salary information; and any unpublished financial data and reports. Unauthorized alteration, destruction, use, disclosure or distribution of these assets violates Company policy and this Code. Any such action, as well as theft or waste of, or carelessness in using these assets have a direct adverse impact on the Company's operations and profitability and will not be tolerated.
The Company provides computers, voice mail, electronic mail (e-mail), and internet access to certain employees for the purpose of achieving the Company’s business objectives. As a result, the Company has the right to access, reprint, publish, or retain any information created, sent or contained in any of the Company’s computers or e-mail systems of any Company machine. Employees may not use e-mail, the internet or voice mail for any illegal purpose or in any manner that is contrary to the Company’s policies or the standards embodied in this Code.
No employee, officer, or director should make copies of, or resell or transfer (externally or internally), copyrighted publications, including software, manuals, articles, books, and databases being used in the Company that were created by another entity and licensed to the Company unless he or she is authorized to do so under the applicable license agreement or by the "fair use" doctrine, such as for "backup" purposes. If you should have any question as to what is permitted in this regard, please consult with the Company's Information Systems Manager, or in his absence, the Chief Financial Officer.
11. Gifts and Gratuities
No employee, officer, or director may solicit a gratuity or gift from an associate or supplier in conjunction with negotiating business on behalf of the Company. Honorariums given as a part of a scientific award or presentation are allowed. If a gift is received, unsolicited, use the following as a guide:
Gifts to government employees are strictly forbidden by both federal and state governments. All other Company gifts require the prior approval of the President or the Chief Financial Officer.
12. Employment Practices
A. Drug/Alcohol-Free Workplace.
The Company recognizes the importance of maintaining a safe and healthy work
environment for its staff and visitors. In addition, the federal Drug-Free
Workplace Act of 1988 requires the Company to certify that it will provide
a drug-free workplace and take specific steps to meet the standards of the
law. Being under the influence of any drug and/or alcoholic beverage on the
job creates serious risks to the health and safety of all personnel.
The unlawful manufacture, distribution, dispensation, possession or use of a controlled substance or illegal drug by any person is prohibited in the workplace. In addition, no personnel shall report to work or perform any Company business including but not limited to the operation of any vehicle on company business whose appearance or odor reflects the illegal consumption of alcoholic beverages or illegal drugs.
Personnel who are found to be in violation of this policy are engaged in serious misconduct and may be subject to disciplinary action up to and including discharge.
Further, given reasonable cause* to suspect any person’s use of illegal drugs and/or alcoholic beverages, the Company reserves the right to have such person tested for such use. The results of such tests shall be used to determine whether or not a violation of this policy has occurred and may be used to ascertain the extent of disciplinary action warranted by such violation, when appropriate. Any person who does not consent to and cooperate fully with the drug and/or alcohol testing procedure will be in violation of this policy.
* Reasonable cause shall exist if a person has been involved in a workplace accident or an incident resulting in personal injury or damage to property, and/or a supervisory employee has a reasonable suspicion that a person is under the influence or impaired by drugs and/or alcohol based on any objective symptoms, such as factors related to the person’s appearance, speech and/or other facts.
As a condition of working for the Company, all Personnel will:
(a) abide by the terms of this Drug/Alcohol-Free Workplace Policy, and
(b) notify the Human Resources Office, in writing, of his/her criminal drug
conviction no later than 5 days after such conviction.
For purposes of this policy, “controlled substance” means a controlled
substance in Schedules I through V of Section 202 of the Controlled Substances
Act (21 U.S.C. 812), and as further defined by regulation at 21 CFR 1308.11
through 1308.15, and “illegal drug” means any drug (a) which
is not legally obtainable or (b) which is legally obtainable but has not
been legally obtained. The term includes prescribed drugs not legally obtained
and prescribed drugs not being used for prescribed purposes.
B. Equality of Opportunity
The Company is committed to provide equal opportunity throughout the Company
without regard to race, color, age, religion, national origin, height, weight
or sex, and with affirmative action consideration for the handicapped and
Vietnam veterans.
This policy applies to all employees, officers, and applicants for employment in connection with: hiring, placement, upgrading, transfer or demotion, recruitment, advertising or solicitation for employment, rates of pay or other forms of compensation, selection for training and layoff or termination.
All employees and officers are expected to respect this Company policy in their daily interactions with other employees, customers, suppliers, and individuals who have dealings with Company.
C. Policy Against Harassment
Our workplace is where we come to achieve and to create, and to be respected
for our achievements and creations. Company will endeavor to provide a
workplace free of the tensions that would be caused by ethnic, sexual,
racial, religious, age-related, or other inappropriate remarks, slurs or
jokes as well as animosity or unwelcome sexual advances or requests for
sexual favors.
Harassment can be words or actions that seem to be based on, race, sex, religion, color, weight, age, national origin, linguistic and language differences, sexual orientation, socio-economic status, handicap, or veteran status.
Sexual harassment is a form of sex discrimination that violates Title VII of the Civil Rights Act of 1964 and includes unwelcome sexual advances, requests for sexual favors, and other inappropriate verbal or physical conduct of a sexual nature when submission to or rejection of this conduct explicitly or implicitly affects an individual’s employment, unreasonably interferes with an individual’s work performance or creates an intimidating, hostile or offensive work environment.
Any employee who alleges harassment by another employee is encouraged to follow these steps:
• Deal with it directly and inform the harasser
that the conduct is unwelcome and must stop, and
• Contact your supervisor, a department Vice President, or Human Resources
and report the complaint.
Complaints of harassment shall be investigated promptly and a determination will be made from the facts on a case-to-case basis. Confidentiality shall be maintained to the extent possible for both the complainant and the accused. A substantiated charge against an employee shall result in disciplinary action, which may include discharge, of the employee conducting inappropriate behavior. An employee will not be retaliated against for bringing inappropriate conduct by others to the Company’s attention.
13. Quality and Regulatory Compliance
The Company is subject to numerous international, federal and state laws concerning the design, clinical development, manufacture, distribution and promotion of its products. The Federal Food, Drug, and Cosmetic Act (“FDC Act”) is the primary regulatory statute governing the Company's activities. The FDC Act is implemented by the Food and Drug Administration (“FDA”) through the promulgation of regulations and by the issuance of guidelines and other informal notices regarding compliance requirements. FDA regulations applicable to medical devices, biologics and pharmaceuticals encompass a wide variety of activities including: product clearance; labeling, advertising, and promotion; reporting requirements; establishment registration and product listing; current good manufacturing practices; preclinical studies, and clinical studies. Other federal agencies also have applicable laws, regulations and guidelines, as do individual state governments. The Company has established policies and procedures to ensure that our activities are conducted in compliance with the federal and state laws and regulations pertaining to FDA-regulated products.4
In addition to legal compliance, the Company is committed to maintaining the highest ethical and scientific standards in researching and developing its products. The Company will be scrupulously accurate in data submitted to FDA, publications, or any other party. The Company will adhere to all standards and procedures necessary to ensure rigorous scientific inquiry and will interact with federal and state agencies in a forthright manner designed to ensure the safe and effective use of its products. Additionally, it is the Company's objective to manufacture its products in a manner designed to ensure their safety, integrity, and suitability for patients, and to market and sell its products in an honest and balanced manner that provides health professionals with the information necessary to use its products appropriately. Clinical studies will be conducted in such a fashion as to safeguard the welfare of subjects and ensure the scientific integrity of the research.
Compliance with FDA regulations requires that we maintain accurate and complete records of all data related to FDA-regulated products. This work includes research and development, preclinical and clinical studies, manufacturing, marketing, quality control and quality assurance, regulatory and other activities as determined by our Quality Systems and Regulatory Affairs department. As part of the Company's quality system, maintenance of reliable documentation is expected and will be monitored. Each employee is responsible for the complete and accurate preparation of documents related to compliance with FDA regulations and the filing of those documents in accordance with Company policies and procedures. The accuracy of data in our records, including full disclosure, lack of material omission, and integrity of the data is a priority of every employee of Company.
Any employee who alters or falsifies data, destroys or fails to maintain product related data, or omits data from records that are needed to provide full information regarding a commercial or development stage product is acting in violation of this Code of Ethics. Any employee aware of or who suspects a violation of data integrity in the accuracy and completeness of records should report this concern. No adverse action shall be taken or permitted against anyone for communicating legitimate concerns through the reporting process specified below.
14. Sales and Marketing Practices
We must preserve the Company’s reputation as a responsible supplier whose products and services are desired for their features, innovation, quality and value and whose people are respected for performance and integrity. Our long-term success depend on building trusting relationships with our customers. We must conduct our business responsibly, fairly, honestly, and in accordance with applicable laws and regulations.
15. Advertising, Sales, and Labeling
We must honestly describe the Company’s products and service features. All advertising, labeling , literature, and public statements must be true. We must not misstate facts or create misleading impressions. We must not unfairly criticize a competitor’s products or services. Some countries prohibit all comments about competitor as well as their products and services. If unsure about a particular instance, consult the CFO or our corporate counsel (Gray Cary) to learn about any applicable laws, before making comments.
We must not promote a product before it is approved or for a use other than that specified in official product literature. When describing products or services, consider the message’s total impression. Omitting important facts or wrongly emphasizing material may be misleading.
16. Clinical Consultants, Grants, Honoraria, and Sponsored Trips
Marketing increases knowledge of products, services or facilities, and enhances the level of medical practice. Marketing practices may include:
Clinical Consultants
Clinical consultants are used to help customers and business partners effectively use our products. Clinical consultants also assist the Company in understanding the marketplace and the current state of medical and scientific research. Sometimes the consultants help the Company understand how our customers and patients use our products.
Many countries have laws restricting payments to medical practitioners, including payments through consulting arrangements. Before establishing any relationship with a clinical consultant, review all applicable laws, regulations, and ethical codes in the countries involved as well as in the United States. The CFO or corporate counsel (Gray Cary) and controllers can help make sure the relationship complies with applicable rules and is properly documented.
Giving Grants or Honoraria or Sponsoring Trips
Giving grants or honoraria or sponsoring trips are marketing activities that can be used to build awareness of the Company and its products and services if all of the following conditions are met:
Accepting Speaking Invitations, Consulting Engagements, Honoraria, or Sponsored Trips
Participation in sponsored events helps our company build positive working relationships. It also enhances the Company’s reputation. Employees may accept invitations to speak at meeting or seminars, consulting engagements, honoraria, or sponsored trips if all of the following conditions are met:
17. Publication of the Code of Business Conduct and Ethics
A copy of the most current version of the Company’s Code of Business Conduct and Ethics will be maintained on the Company’s website. From time to time, the Company will sponsor employee-training programs in which the Code and other Company policies and procedures will be discussed.
18. Waivers of the Code of Business Conduct and Ethics
Any waiver of this Code may be made only by the Board and will be promptly
disclosed to shareholders.
19. Compliance Procedures
The Company has established this Code of Business Conduct and Ethics as part
of its overall policies and procedures. The Code applies to all Company employees
in all locations, and to all officers and directors. The Code is based on
the Company’s core values, good business practices and applicable law.
The existence of a Code, however, does not ensure that directors, officers
and employees will comply with it or act in a legal and ethical manner. To
achieve optimal legal and ethical behavior, the individuals subject to the
Code must know and understand the Code as it applies to them and as it applies
to others. All employees must champion the Code and assist others in knowing
and understanding it.
Provided By DLA Piper