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AdvaMed Code of Ethics on Interactions with Healthcare Professionals
Outcomeus is dedicated to upholding the highest ethical, quality and compliance standards consistent with applicable policies, standards and laws. Outcomeus operates in a highly complex and regulated business environment. Outcomeus's reputation for integrity and doing the right thing for the right reason is an intangible asset that is highly valued by Outcomeus and its employees. Our reputation gives us credibility, and creates value for each of our stakeholders - patients, physicians, employees, contractors, Board of Directors, shareholders, regulators, policy makers, payers, and the community.
Outcomeus (“Outcomeus” or the “Company”) has adopted a Comprehensive Compliance Program (“Compliance Program”), summarized below and consistent with guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”). Outcomeus's Compliance Program is intended to promote the prevention and resolution of actual or apparent conflicts of interest, appropriate disclosure in Company reports and public communications, compliance with applicable laws and regulations, accountability and prompt reporting of violations of Company policy relating to the sale and marketing of Outcomeus's products. It is Outcomeus's expectation that all employees, officers, directors, agents, representatives, consultants and distributors shall comply with Company policies and procedures as well as all of the laws, rules and regulations of the U.S. and other countries, and the states, counties, cities and other jurisdictions, applicable to the Company's sale or marketing of its products. The strategic objectives of our Compliance Program are:
  • To promote an organizational culture that encourages a passion to make a difference in the world, engage in ethical conduct, a commitment to integrity and quality, and compliance with applicable laws and regulations.
  • To exercise due diligence to prevent, detect and correct potential violations of the Compliance Program, applicable federal and state law, and Company policy.
  • To provide a comprehensive approach to identifying, managing and mitigating organizational risk.
The OIG advises that an effective compliance program is comprised of seven elements. Outcomeus has used these seven elements as a basis for its Compliance Program.
Fundamental elements of our compliance program are summarized below.
Written Policies and Procedures:
Outcomeus has adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals as the Company's primary statement of policies for assuring compliance with applicable laws, regulations and standards governing the marketing and promotion of Outcomeus products. To the best of its ability and consistent with the OIG's guidance regarding tailoring compliance programs to the nature of Outcomeus's business.
Compliance Leadership:
The Company has appointed a Compliance Committee headed by the Chief People Officer, Lisa Beggs, to help the Company meet legal and regulatory requirements applicable to the Company.
Education and Training:
The Company trains appropriate employees on their legal and ethical obligations and Outcomeus's policies and procedures concerning marketing and promotional activities relevant to Outcomeus products. Outcomeus regularly reviews and updates its training programs as needed. The Compliance Committee will work with other employees to implement or update appropriate training programs, including specialized training as needed, as well as documenting and maintaining records of such training.
Outcomeus encourages employees to talk to supervisors, managers, the Compliance Officer, any member of the Compliance Committee or other appropriate personnel about suspected illegal or unethical conduct or violations of Outcomeus's policies. Outcomeus has adopted open-door, confidentiality (to the extent possible) and non-retaliation policies in the event an employee is concerned about a potential violation. Employees may also use the Company's anonymous Hotline at 844-420-0044 (English speaking USA and Canada) or 800-216-1288 (Spanish speaking North America). All reports will be referred to the Compliance Officer for review and for submission, as appropriate, to the Compliance Committee or other appropriate committee.
Auditing and Monitoring:
The Compliance Committee and other members of Outcomeus's senior management, are responsible for auditing and monitoring compliance with Company policies and procedures. The Compliance Committee will work with other employees to audit and monitor compliance, as well as to document and maintain records of such audits.
Enforcement and Appropriate Disciplinary Action:
All reported potential violations shall be forwarded to a member of the Compliance Committee. A member of the Compliance Committee or an appointed delegate will, when possible, confirm receipt of the report to the individual making such report unless such report was made anonymously. The Compliance Committee member or delegate also will investigate reports of suspected violations brought to the Company's attention and, with input from other members of the Compliance Committee, will take appropriate disciplinary action to address inappropriate conduct and deter future violations by employees or third parties with whom the Company does business.
Corrective Action Procedures:
As needed and on an ongoing basis, the Compliance Committee will assess the need to revise policies, procedures, training, communication or other elements of Outcomeus's Compliance Program to improve its content or address gaps, if any.
Any employee who suspects a violation of the Company policy, financial fraud, accounting irregularities, or auditing issues should promptly contact the Compliance Committee, the Legal Department or Human Resources. Any employee wishing to make an anonymous report regarding suspected illegal behavior or financial fraud of any type may do so by calling the Company's anonymous hotline at 844-420-0044 (English speaking USA and Canada) or 800-216-1288 (Spanish speaking North America). The anonymous hotline is intended only for reporting potential financial fraud, concerns regarding accounting controls or irregularities, auditing issues or illegal or unethical behavior in violation of Outcomeus's policies. For other workplace issues, employees should contact their manager or Human Resources. The Company will investigate and treat confidentially (to the extent possible) all reported potential violations. All employees are expected to cooperate in any internal or external investigations of possible violations of Company policy. The Company will not permit retaliation of any kind by, or on behalf of, the Company or its employees against good faith reports or complaints of potential violations involving financial irregularities, violations of Company policy or other illegal or unethical behavior.
Adopted: August 31, 2023
Last revised: August 31, 2023
Code of Business Conduct & Ethics
Outcomeus, Inc. (“Outcomeus”) is committed to conducting all business affairs in an honest, fair, ethical and legal manner. As a representative of Outcomeus, you are expected to conduct yourself in a similar manner. The purpose of this Code of Business Conduct and Ethics (the “Code”) is to set forth the guidelines for conducting Outcomeus's business consistent with the highest standards of business ethics and the law. All references to Outcomeus, “we,” “our” and “us” in this document include any subsidiaries of Outcomeus, Inc.
This Code applies to all members of Outcomeus's Board of Directors, and all officers and employees of Outcomeus, wherever they are located and whether they work for Outcomeus on a full- or part-time basis. We also expect that anyone conducting work on Outcomeus's behalf in any consulting or advisory capacity will adhere to the provisions of this Code in the course of such work. Therefore, all vendors, service providers, temporary workers, independent contractors and consultants (the “trade”) who provide services to Outcomeus and who we designate will be provided with a copy of this Code and will be expected to abide by it. All persons covered by this Code are referred to as “Outcomeus employees” or “employees” in the Code whether or not you fall into the trade category above. Such designation in no way implies or creates a contract for employment between you and us.
Seeking Help and Information
The Code is just one element of our overall effort to ensure lawful and ethical conduct in all aspects of Outcomeus's business. The Code is not intended to be a comprehensive document that addresses every situation that you may face while working at, for or with Outcomeus. In fact, there are many policies and procedures not covered by the Code, such as those covered in our detailed employee handbook. These and similar policies, while not a part of the Code, provide additional guidance on acceptable standards of conduct to be observed in the representation of Outcomeus. The Code does not take the place of or modify other more detailed written policies. Rather, this Code establishes key standards and general guidelines that Outcomeus expects all employees to follow.
If you are faced with a difficult business decision that is not addressed by the Code, you should ask yourself the following questions:
Is it legal?
Is it honest and fair?
Is it in the best interests of Outcomeus?
Would I feel comfortable if an account of these actions were published with my name on the front page of the newspaper?
If your answer to any of these questions is “no” then don't do it. If you aren't sure about the answer to any of these questions or still feel uncomfortable about a situation, please seek help. We urge you to contact your supervisor for help. If your supervisor cannot answer your question, or if you are not comfortable discussing the situation with your supervisor or with your supervisor's answer, feel free to contact the Chief People Officer.
Chief People Officer
The Company's Chief People Officer is responsible for monitoring performance under the Code, assuring compliance with all other applicable local, state, and federal laws and regulations, and resolving concerns or questions relating to ethics. The Chief People Officer can be reached at compliance@Outcomeusgenomics.com. In the absence of the Chief People Officer, you can contact the President and Chief Executive Officer, who has established an “open door policy” for all employees, at ceo@Outcomeus.com.
Supplies, equipment, proprietary products, formulas, customer and supplier mailing lists and any and all company documents produced by Outcomeus employees or contracted third parties, belong to Outcomeus and are to be used solely for Outcomeus's benefit. Employees and all of our outside third-party vendors or service providers should protect Outcomeus's assets and ensure that they are used efficiently and for legitimate business purposes. Outcomeus property must not be taken for personal use or gain, or given away, sold or traded without proper corporate authorization. Furthermore, Outcomeus property should never be used for any improper or unlawful purpose.
To ensure the protection of Outcomeus's assets, you should:
  • Exercise reasonable care to prevent loss, damage, theft, carelessness or waste of Outcomeus property;
  • Promptly report any actual or suspected theft, damage or misuse of Outcomeus property to a supervisor or a member of the Compliance Committee;
  • Safeguard all electronic programs, data, communications and written materials from inadvertent access by others; and
  • Use Outcomeus's communications systems, services, written materials and other property primarily for business-related purposes (see “Communication Systems” below).
Communications Systems
We provide or contract for the communications services and equipment necessary to promote the efficient and effective conduct of our business. These services and equipment include, but are not limited to, e-mail, computers, computer applications, computer networks, Internet, facsimile, telephone systems, voice mail, cellular phones, video equipment and tapes, tape recorders and recordings, and Company bulletin boards. Use of these services and equipment should be primarily for business purposes; personal use should be kept to a minimum and any improper use of these services and equipment (e.g., hacking, pirating software, sending harassing, offensive, demeaning or sexually suggestive e-mails or communications, accessing inappropriate web sites, etc.) is prohibited.
You should be aware that all Outcomeus communications services and equipment, including the messages and documents transmitted or stored by them, are the sole property of Outcomeus. You should not have any expectation of privacy when using these services and equipment. To the extent permitted by law, Outcomeus has the ability and reserves the right to access and monitor employee communications and files at any time, without notice and at Outcomeus's sole discretion.
For further information on our policies regarding communications services and equipment, see the “Communications Systems Policy” in the employee handbook.
Confidential Information
It is Outcomeus's policy that the internal business affairs of the organization, particularly confidential information and trade secrets, represent proprietary assets that each employee or contracted vendor or service provider has a continuing obligation to protect.
As an Outcomeus employee, vendor or service provider, you must:
  • Never reveal to any person, unless authorized to do so by Outcomeus, any confidential information;
  • Protect Outcomeus confidential information and use it only for appropriate and authorized purposes;
  • Not allow others to misappropriate Outcomeus confidential information; and
  • Disclose promptly to Outcomeus all ideas, discoveries, developments, and improvements, whether patentable or not, which have been made or conceived by you while working for or on behalf of Outcomeus.
For more information on what constitutes “confidential information” and our policies regarding use and disclosure of confidential information, see the “Confidential Records and Information Policy” in your employee handbook. You should also refer to the “Confidentiality and Invention Assignment Agreement” or similar agreement between you and Outcomeus. Please note that your obligations to protect Outcomeus's confidential information continue even after you leave Outcomeus. Any ideas, discoveries, developments, and improvements, whether patentable or not, which have been made or conceived by you while working for or on behalf of Outcomeus shall at all times be the property of Outcomeus and shall not entitle you to any additional compensation upon termination of your relationship with Outcomeus.
Corporate Travel Policy
We recognize that many employees may incur travel expenses to further our business objectives. Outcomeus's policy is to reimburse employees for any reasonable and necessary expenses incurred in connection with the performance of company business. For further information on our travel policies, please refer to the “Employee Travel and Expense Reimbursement Policy” in the employee handbook.
Accurate and reliable records are essential to Outcomeus's business. Our records form the basis for our financial reports and other public disclosures, and are the source of critical data that guides management's decision-making and strategic planning. Our records include sales and booking information, employee records, payroll, timecards, expense reports, accounting and financial data, production and performance records, electronic data files, e-mails, research and development records, manufacturing records, distribution information and all other records kept in the ordinary course of our business.
Employees responsible for financial records and employees who prepare other company records and reports are obligated, ethically and legally, to assure that such documents are accurate, complete, safeguarded against loss or destruction, retained for specified periods as may be established by Outcomeus or otherwise required by law, and maintained in confidence. There is no valid reason for making or allowing others to make false or misleading entries in our records. With regard to all Outcomeus books and records, there must be full and candid communication by all employees responsible for keeping the books and records with upper management, internal auditing personnel, independent auditors and, if appropriate, legal counsel for Outcomeus.
Financial Records and Controls
Outcomeus employees who are responsible for receiving or disbursing money have a special obligation to follow established procedures to ensure proper use and recording of all funds. Compliance with generally accepted accounting principles, rules and controls is necessary at all times and no deviation from those standards will be tolerated. All Outcomeus records must reflect accurately and properly describe the transactions they record.
All assets, liabilities, revenues and expenses of Outcomeus are to be recorded in our regular books. Whenever possible, any employee approving an expense must be separate from the employee(s) that approves the payment of such expense. In this regard, and without limitation, employees responsible for keeping Outcomeus's books must refrain from all of the following: Maintaining or establishing undisclosed or unrecorded funds, assets or accounts of Outcomeus for any purposes; Making false or artificial entries in the books and records for any reason (no employee shall engage in any arrangement that results in such improper entries or records); and Making or approving any disbursement for expenses with the intention of paying for something other than that described in documents supporting the payment or anything prohibited by law. Research and Development, Compliance and Clinical Affairs Records Further, because the pharmaceutical industry is regulated, and to assure the continued quality of Outcomeus's products, it is important that all record keeping by employees conforms to the highest standards of scientific research and the standards established by governmental regulatory agencies, such as the Officer of Inspector General (“OIG”). This is especially true for all records kept in connection with the research and development, lab compliance and clinical affairs activities related to the creation and use of our testing profiles.
All documents must include at a minimum a list of the following: · Author's first initial and last name · Published Date (P) · Retention Date (R)** · Creator's initials · File Path** · ** Will be required upon implementation of new document management system and release of revised document retention and destruction policy.
The submission of false or inaccurate data or other information in any government filing or submission may subject you and/or Outcomeus to civil and criminal sanctions. Thus, each employee involved in government filings and submissions must exercise the highest degree of diligence to assure the accuracy of the data and information contained in such submissions.
Employees must not willfully or knowingly falsify, alter, remove or destroy any Outcomeus records required to be maintained by law or by Outcomeus policy.
Identifying a Conflict of Interest
A conflict of interest may occur when you, or one of your family members, has a private interest that interferes, or appears to interfere, with the interests of Outcomeus. In that situation, your loyalties may be divided, which could make it difficult for you to perform your work objectively and effectively and to act in the best interests of Outcomeus. Accordingly, conflicts of interest are prohibited unless they are specifically waived as described in the section entitled “Compliance with the Code—Waivers of the Code” below. The following are just a few examples of situations that could lead to a conflict of interest:
  • Outside Employment — Provision by you or any family member of any services to a company that is engaged in a business that is the same as or similar to the business of Outcomeus, or any business that Outcomeus is engaged in developing, or to any material customer or supplier of Outcomeus. Please note that any outside employment, whether or not to a company identified above, requires prior written approval from your supervisor.
  • Service on Boards or Committees — Service by you or a family member on the board of directors or trustees or committee of any entity (whether not-for-profit or profit) whose interests could reasonably be expected to conflict with those of Outcomeus.
  • Receipt of Improper Personal Benefits — The receipt by you or any family member of improper personal benefits or favors from others as a result of your position with Outcomeus.
  • Investments — The holding by you or any family member of a significant financial interest in any company that is a competitor or a material customer or supplier of Outcomeus.
  • Loans or Other Financial Transactions — The receipt by you or any family member of a loan or guarantee of a personal obligation or entry into any financial transaction with a company that is a competitor or a material customer or supplier of Outcomeus.
This list does not identify every possible conflict of interest that may occur. If you are unsure whether a situation presents a conflict of interest, discuss it with your supervisor or the Chief People Officer.
Disclosure of Conflicts of Interest
You must fully disclose any situation that reasonably could be expected to give rise to or be perceived as a conflict of interest to your supervisor or the Chief People Officer. Your supervisor or the Chief People Officer will work with you to determine whether a conflict of interest exists and, if so, how best to address it.
Corporate Opportunities
As a Outcomeus employee, you should advance the interests of Outcomeus whenever you have an opportunity to do so. If, through the use of Outcomeus property, information or because of your position with Outcomeus, you discover or are presented with a business opportunity that is related to Outcomeus's business, you must immediately disclose it to your supervisor or the Chief People Officer. Your supervisor or the Chief People Officer will discuss the opportunity with the appropriate members of management to determine whether the situation is a corporate opportunity and, if so, whether Outcomeus would like to pursue it. Any officer or member of the Board of Directors of Outcomeus who wishes to pursue a business opportunity that is related to Outcomeus's business must first fully present the opportunity to the Board of Directors. If Outcomeus decides not to pursue the opportunity, then you may pursue it on the same terms and conditions as originally proposed, provided that your conduct is consistent with the other guidelines set forth in this Code.
We understand that the giving and receiving of gifts and other business courtesies is a common practice. However, gifts, entertainment or any other payment to a third party should never compromise, or even appear to compromise, your ability to make objective and fair business decisions.
Outcomeus's policy is that employees may not give any gift or present to a customer, supplier or any other person valued at more than $75.00 – other than as stated in the AdvaMed Code of Conduct which has previously been distributed to you. In addition, business and entertainment expenses must be customary and reasonable and must be properly authorized. When dealing with healthcare professionals, any more restrictive limits imposed by the AdvaMed Code of Conduct MUST be followed. Full disclosure of gifts and entertainment must always be recorded in writing, using Outcomeus's expense reimbursement forms, and approved by a supervisor or senior manager. For further guidance, please consult the “Employee Travel and Expense Reimbursement Policy” in the employee handbook. Gifts or any other forms of remuneration to any employee of a local, state, federal, or international government are strictly prohibited.
Conversely, employees are prohibited from soliciting gifts, entertainment or favors, directly or indirectly, from anyone doing business with Outcomeus. Our purchasing decisions should be based solely on what is right for product quality and value. Accordingly, relations with suppliers should always be objective, free from the influence of gifts or favors. Nominal gifts valued at less than $75.00 or reasonable entertainment may be accepted from suppliers only within established guidelines and with the full knowledge of the appropriate managers. You should make every effort to refuse or return a gift that is beyond these permissible guidelines. If it would be inappropriate to refuse the gift, or you are unable to do so, then you should promptly report the gift to your supervisor or the Chief People Officer, who will help determine the appropriate course of action.
Additionally, if you conduct business in countries other than the United States, you must be particularly careful that gifts and entertainment are not construed as bribes, kickbacks or other improper payments. See “Compliance with Other Laws and Regulations —Bribery and the Foreign Corrupt Practices Act” below for a more detailed discussion of our policies regarding giving or receiving gifts related to business transactions in other countries. In other transactions or dealings with independent, non‑employee commercial agents, consultants or other third parties for any purpose, payments must be limited to reasonable compensation for services and reimbursements for reasonable expenses, and must not include any extraordinary gifts, commissions or fees. Employees must review all contracts and agreements with consultants and third parties with the Finance Department before committing to the agreement. The Chief People Officer must approve all contracts before they are entered into. No consultants or other third parties may be used to make an indirect payment that would be prohibited by this Code if made directly.
If you have any questions about whether to is acceptable to receive or give a gift or something else of value, contact your supervisor or the General Counsel for additional guidance
It is our policy that no corporate funds may be used to make political contributions of any kind to any candidate or political party, unless specifically approved by the Compliance Committee. This prohibition covers not only direct contributions but also indirect assistance or support of candidates or political parties through the purchase of tickets to special dinners or other fund-raising events, and the furnishing of any other goods, services or equipment to political parties or committees. Political contributions or activities by individuals on their own behalf are, of course, permissible. However, when you participate in political affairs, you should be careful to make it clear that your views and actions are your own and are not expressed or made on behalf of Outcomeus. For instance, Outcomeus letterhead should not be used to send out personal letters in connection with political activities. No person may be reimbursed directly or indirectly by the company for any political contribution or for the cost of attending any political event.
Outcomeus is a determined but fair competitor. All Outcomeus employees are required to deal fairly with customers, suppliers, competitors, other third parties and, of course, with fellow employees.
Relationships with Customers Our success depends upon our ability to form and maintain lasting customer relationships. Outcomeus is committed to dealing with all customers fairly, honestly and with integrity. When dealing with customers, you should always remember that the information we provide customers must be current, accurate and truthful to the best of your knowledge; you must never deliberately misrepresent information to a customer. In addition, you should not refuse to sell or provide services to a customer simply because that customer is buying products from another supplier. You should never provide gifts, entertainment or other benefits to a customer that could be viewed as an inducement or reward for their purchase decisions. See “Gifts, Entertainment and Other Forms of Payments to Third Parties” above for additional guidelines. Any promises or arrangements regarding discounts, credits, rebates or other price adjustments must be promptly communicated to Outcomeus's sales and finance management personnel.
Relationships with Suppliers Outcomeus's relationships with suppliers are based on price, quality of service and reputation. Payments to suppliers must be commensurate with the services or products being provided. You should not accept or solicit any personal benefit from a supplier or potential supplier that might compromise your objective assessment of that supplier's products or prices. See the sections of this Code entitled “Conflicts of Interests” and “Gifts, Entertainment and Other Forms of Payments to Third Parties” above for further guidance.
Relationships with Competitors Outcomeus competes vigorously, but fairly. You should avoid any actions that could be viewed as being anti-competitive, monopolistic or otherwise contrary to laws that govern competitive practices in the marketplace, including federal and state antitrust laws. You should not obtain or give competitive information to others by unethical or illegal means. Further, it is improper to make false or misleading statements about a competitor. If you are in a position to speak on behalf of Outcomeus, you must ensure that your statements are accurate and you should try to refrain from commenting on another company's reputation or financial or legal situations. See “Compliance with Antitrust Laws” below for further information on this topic.
The U.S. and other countries have adopted antitrust laws to protect consumers and competitors against unfair business practices and to promote fair competition in the marketplace. Outcomeus is fully committed to complying with antitrust, monopoly, competition and cartel laws in the U.S. and any other countries, states or localities in which we compete.
Actions that Violate U.S. Antitrust Laws All employees should be familiar with the general principles of the U.S. antitrust laws. The following is a summary of some of the actions that violate U.S. antitrust laws: Price Fixing. Outcomeus may not agree with competitors to raise, lower or stabilize prices or any elements of price, including discounts or credit terms. Limiting Supply. We may not agree with competitors to limit production or restrict the supply of products or services. Allocating Business. We may not agree with competitors to divide or allocate sales, markets, territories or customers. Boycotting. We may not agree with competitors to refuse to sell or purchase products from third parties. We also may not prevent a customer from purchasing or using non-Outcomeus products or services. Tying. We may not require a customer to purchase a product that it does not want as a condition to the sale of a different product that the customer does wish to purchase. Foreign Antitrust Laws
Numerous other countries, including virtually all other major commercial countries, have adopted antitrust laws that prohibit many of the same activities that are prohibited in the U.S. However, you should be aware that there may be differences in those laws. For example, in some countries the government fixes the price at which a pharmaceutical product may be sold to the public. It is your responsibility to understand and comply with all laws and regulations that are relevant to your job.
Getting Additional Guidance Violations of antitrust laws can result in serious consequences that may expose Outcomeus and you to substantial civil damages, criminal fines and, in the case of individuals, potential prison terms. Therefore, if you have any questions regarding whether a course of action may be considered anti-competitive, please contact your supervisor or the Chief People Officer for further guidance.
Outcomeus is committed to providing a safe and healthy work environment for all employees. We also strive to avoid or minimize any negative impact we may have on the environment and the communities in which we operate. As a Outcomeus employee, you are expected to comply with all applicable environmental, health and safety laws and regulations, as well as Outcomeus policies. It is your responsibility to understand and adhere to the laws, regulations and policies that are relevant to your job. Any failure to comply may result in civil and/or criminal liability against you and Outcomeus, as well as disciplinary action by Outcomeus, up to and including termination of your employment. If you have any questions about the laws, regulations or policies that apply to you, please contact your supervisor or the Compliance Committee.
Environment You should make every effort to conserve resources and reduce waste through recycling and other energy conservation measures. You are required to promptly report any known or suspected violation of environmental laws or any practices or events that may lead to the discharge or emission of hazardous materials. Employees engaged in manufacturing should be particularly careful to safeguard the environment, paying special attention to the storage, transportation and disposal of waste and handling of potentially toxic materials.
Health & Safety All Outcomeus employees are required to comply with any health and safety laws, regulations or policies that are relevant to their jobs. If you have a concern about a condition or task that you believe may present a risk to the safety of yourself or others, please report it immediately to your supervisor or the Human Resources Department.
We are committed to treating all employees and applicants with honesty, fairness and respect. We expect our employees to treat each other and those with whom they have business or professional relationships in the same manner. The following sets forth a summary of some of our most important employment policies and practices. You are expected to comply with these policies and practices, as well as with all applicable employment and labor laws. It is your responsibility to become familiar with and understand all laws, regulations and policies that are relevant to your job and the jobs of those you supervise. Failure to comply with employment and labor laws could subject you and Outcomeus to civil and/or criminal liability, as well as disciplinary action by Outcomeus, up to and including termination of your employment. Employment and labor laws may vary depending on where you are located. You should contact your supervisor, Human Resources or the Chief People Officer if you have any questions about these laws or policies.
Discrimination Outcomeus's policy is to provide equal opportunity to all employees or applicants for employment, regardless of race, color, religion, gender, national origin, ancestry, age, physical or mental disabilities, medical conditions, veteran status, marital status, sexual orientation or other characteristic protected by law. Unlawful discrimination in the recruiting, hiring, training, promotion, retention, development, termination or treatment of employees will not be tolerated. Please refer to Outcomeus's “Discrimination Policy” in our employee handbook for further guidelines on what is considered impermissible discrimination.
Harassment We are committed to providing a workplace free of harassment, including sexual harassment (such as harassment based on gender, pregnancy, childbirth or related medical conditions) or harassment based on factors such as race, color, religion, gender, national origin, ancestry, age, physical or mental disabilities, medical conditions, veteran status, marital status, sexual orientation or another basis protected by law. Harassment can take the form of verbal or physical conduct, displays of offensive objects or pictures, or any other action that creates a hostile work environment. Outcomeus prohibits harassment in any form by any manager, supervisor or employee. For further information on our policies regarding harassment, please refer to the “Harassment Policy” in our employee handbook.
Alcohol and Drugs All Outcomeus employees are expected to comply with our policies regarding the use of alcohol and possession, sale or use of illegal substances in the workplace. Drinking of alcoholic beverages is prohibited while on duty or on Outcomeus's premises, except at specified company-sanctioned events. The possession, sale or use of illegal drugs or other controlled substances is strictly prohibited under all circumstances while on duty or on Outcomeus property. Likewise, you may not report to work, drive a company vehicle or drive any vehicle while conducting Outcomeus business while under the influence of alcohol or any illegal drug or controlled substance. Failure to comply with these policies will subject you to disciplinary action by Outcomeus, up to and including termination of your employment.
Prevention of Violence and Weapons The safety and security of our employees is of utmost importance to us. Outcomeus prohibits the use of violence or threats of violence in or related to the workplace. If you experience, witness or otherwise become aware of a violent or potentially violent situation on Outcomeus's premises or related to our business, please report it immediately to your supervisor, the Human Resources, or the Compliance Committee.
Weapons of any kind are prohibited at Outcomeus and in any Outcomeus vehicle while on the job or off-site conducting Outcomeus business. This policy applies even if you have legal permits to carry weapons. The only exception to this policy applies to security personnel who are specifically authorized by Outcomeus's management to carry weapons.
We do not authorize, condone or tolerate business activities that are not within both the letter and spirit of the law. All employees are expected to comply with the laws and regulations of the U.S. and any state, city or other jurisdiction in which we operate. This includes, but is not limited to, laws relating to unfair competition, antitrust prohibitions, the development, testing, approval, manufacturing, marketing and distribution of pharmaceutical and cosmetic products, environmental hazards, occupational health and safety, and employment discrimination or harassment discussed above, as well as laws covering bribery and kickbacks, foreign corrupt practices, insider trading, public disclosures, patents, copyrights, trademarks and trade secrets, information privacy, and the misuse of corporate assets. You are expected to understand and comply with all laws, rules and regulations that apply to your job. If you have questions about whether an action is legal, please do not hesitate to ask your supervisor, Human Resources or the Chief People Officer.
Bribery and the Foreign Corrupt Practices Act Outcomeus forbids payments of any kind to any person to obtain an advantage in selling products or to advance our interests with government authorities. Any such payment, made anywhere in the world, violates Outcomeus's policies. In addition, the Foreign Corrupt Practices Act forbids the making, offering or promise of payment or anything else of value to a government official (and in the U.S., to foreign political parties and candidates) to win or retain business or influence an official act. For this reason, no payments, gifts or services should be given to any government official.
Outcomeus also prohibits “commercial bribery,” which violates the laws of many countries. Commercial bribery refers to the providing of something of value to an intermediary (e.g., an employee of a customer) without his or her supervisor's knowledge, with the intent to influence the supervisor's commercial conduct.
Public Communications What is written or said about Outcomeus in the news media and investment community directly impacts our reputation and credibility. Accordingly, announcements of company information may only be made by persons specifically authorized by Outcomeus to make such announcements. If you receive an inquiry about the company from a reporter, investor, potential investor, analyst or anyone else from the financial community, you should decline to comment and refer the person to our CEO, Chief Communications Officer or Chief People Officer. Laws and regulations govern the nature and timing of our announcements to outsiders or the public and an unauthorized disclosure could result in substantial liability for you and Outcomeus. For further information, please refer to the “Corporate Disclosure Policy” in your employee handbook.
Government Submissions You may not knowingly alter or submit false data or information to any government organization. Submission of such information not only subjects you and Outcomeus to the possibility of severe civil and criminal sanctions, but is extremely damaging to our reputation among consumers, suppliers and regulators.
Patents, Trademarks and Copyrights In addition to protecting Outcomeus's intellectual property—including our patents, trade secrets, copyrights, trademarks, technical knowledge and know-how—you are expected to respect the valid intellectual property rights of others. Unauthorized use of the intellectual property rights of others could expose Outcomeus to civil lawsuits and damages. Similarly, the theft or misappropriation of another's intellectual property could result in significant fines and criminal penalties against Outcomeus and/or you.
Other Laws Governing Our Business Privacy issues are a growing, global concern. Rapidly developing technology for data use and transfer presents new challenges to maintaining the confidentiality of personal information. In addition, different cultures have different expectations regarding what types of information should be protected. Many countries have recently enacted or strengthened their privacy laws to protect personal information. Employees who work with personal information regarding Outcomeus employees or persons participating in research or clinical studies involving our products should be familiar and comply with all such applicable laws.
Outcomeus's products are also distributed in numerous foreign countries. As a result, Outcomeus must comply with all laws governing international trade with foreign companies and countries, including licensing, shipping documentation and reporting and record retention requirements. Employees who are engaged in international sales or distribution have an additional responsibility to understand and comply with all applicable laws.
Reporting Violations of the Code As an Outcomeus employee, you have a duty to report any known or suspected violation of this Code, including any laws, rules, regulations or policies that apply to Outcomeus. You should not consider reporting a known or suspected violation of the Code as an act of disloyalty, but rather as an action to protect our reputation and the reputation of our employees.
Anyone wishing to report a violation or suspected violation of the Code may present it to his or her supervisor or directly to the Chief People Officer (whose contact information appears on page 2 of the Code) or any member of the Compliance Committee. In the absence of the Chief People Officer or a member of the Compliance Committee, reports may be made to the President and Chief Executive Officer (whose contact information also appears on page 2 of the Code). If you wish to report an issue related to Outcomeus's accounting, internal controls or auditing practices or policies, you should contact the Audit Committee of the Board of Directors. Please see the “Whistleblower Policy” in our employee handbook for information regarding how to contact the Audit Committee. You may also report any such violations If you wish, you may submit your report anonymously through our anonymous hotline maintained by Lighthouse at www.Lighthouse-Services.com/Outcomeus. However, please keep in mind that you should try to provide as much information as possible in your report to enable Outcomeus to conduct a thorough investigation of the matter. Reports of alleged violations should be factual, rather than speculative or conclusory, and should contain as much specific detail as possible to allow for proper assessment. All reports of known or suspected violations of the Code, whether or not they were submitted anonymously, will be treated with sensitivity and discretion and kept in strict confidence to the extent possible, consistent with Outcomeus's need to conduct an adequate investigation. For further information on reporting violations of the Code and the process for the investigation and resolution of reports, please refer to our “Whistleblower Policy.”
Enforcement of the Code Failure to comply with the standards contained in this Code can be cause for disciplinary action that may include, but is not limited to, a written warning, suspension from work, referral for criminal prosecution, reimbursement for any losses or damages resulting from the violation, and termination of your employment. Violation of standards established by law may also result in civil or criminal liability. We are committed to flexibility in our disciplinary policy. No single set of disciplinary options is appropriate in every case. We, therefore, retain sole discretion to structure disciplinary sanctions as the circumstances may warrant.
Policy Against Retaliation Outcomeus employees should feel confident to report violations or suspected violations of the Code or to assist in an investigation of an alleged violation. We will not tolerate retaliation or discrimination of any kind against any employee who in good faith reports, or assists in the investigation, of a violation or suspected violation of the Code. Anyone who does so retaliate against an employee will be subject to disciplinary action, up to and including termination of employment.
Waivers of the Code Waivers of the Code may be granted on a case-by-case basis. Waivers must be made in writing and may be made only by the Chief Executive Officer and Chief People Officer, acting together, for any employee of Outcomeus who is not an executive officer. Any waiver of the Code for an executive officer or member of the Board of Directors may only be made by our Board of Directors or the appropriate committee of the Board of Directors.
Note: The Code is not a contract. Employment with Outcomeus is at-will and can be terminated at any time for any reason, with or without cause, and with or without notice. The at-will nature of the employment relationship can only be superseded by a written document signed by the President and CEO. Violation of the Code or any other personnel policies are taken quite seriously and can result in discipline, up to and including termination.
At Outcomeus, quality is central to our commitment to provide superior personalized medicine testing. Our comprehensive quality program incorporates the International Council for Harmonisation (ICH) E6: Guideline for Good Clinical Practice (GCP); Electronic Records, Electronic Signatures (21 CFR Part 11); Protection of Human Subjects (Informed Consent) (21 CFR Part 50); Financial Disclosure by Clinical Investigators (21 CFR Part 54); Institutional Review Boards (21 CFR Part 56); International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences (CIOMS 2016); The general principles arising out of the Declaration of Helsinki (World Medical Association) and the United States (US) Belmont Report (1979); Lean Six Sigma; Baldrige Performance Excellence Framework and ISO Standards including ISO 15189/ISO 9001. Outcomeus is committed to providing the highest quality services in full compliance with all federal, state, and local laws and regulations. At Outcomeus, however, we pride ourselves in going beyond merely complying with minimum requirements. We strive for the highest achievable level of quality and performance excellence. Outcomeus's Quality Program is aimed at achieving excellence for the entire business, by climbing to the top of the quality continuum. Our investment in quality and continuous improvement isn't required but is a commitment we make because our patients and clients count on us.
Adopted: August 31, 2023
Last revised: August 31, 2023