Our Responsibility as Employees
URL Pharma is committed to providing excellent service to patients, customers, employees, and owners, by providing beneficial high-quality products to the pharmaceutical market. We fulfill this commitment while upholding the highest level of ethical conduct and meeting our responsibilities as good corporate citizens.
Each URL Pharma employee shares responsibility and is accountable for:
- Adhering to the highest ethical standards when interacting with healthcare professionals;
- Adhering to Company standards for safe operation of facilities and equipment, for production of safe
- products, and for protection of the environment;
- Treating all customers, suppliers and co-workers in an honest and fair manner;
- Conducting the Company’s business with integrity and operating in compliance with all applicable laws;
- Avoiding situations where personal interests are or appear to be in conflict with Company interests;
- Safeguarding and properly using Company proprietary information, assets, and resources;
- Maintaining confidentiality of nonpublic information and not acting on such information for personal gain or the gain of another company or individual.
Underlying these responsibilities is a philosophy that we must maintain respect and dignity for the individual and ensure that each person is treated fairly.
This Code establishes standards that govern all of our business practices and should be treated as essential. To maintain our standard of excellence and integrity in the business community, it is imperative that each employee comply with these standards of business conduct and the policies that are established to complement them. If any aspect of this Code is unclear to you or if you are uncertain whether any individual situation adheres to our business policies overall, it is your responsibility to seek clarification from your manager or URL Pharma legal counsel.
Healthcare Compliance Committee (HCC)
To further the understanding and execution of compliance and ethical practices, URL Pharma has established a Healthcare Compliance Committee (HCC) to oversee and monitor implementation of the Company’s Healthcare Compliance Program, which includes elements recognized by the Office of Inspector General (OIG) for the Department of Health and Human Services as pertinent to an effective compliance program. The HCC is comprised of senior managers from various functions and disciplines within the Company, such as Regulatory Affairs, Medical Affairs, Sales and Marketing, Clinical Operations, Legal, and Finance.
The HCC is responsible for developing healthcare compliance policies, coordinating compliance training and education programs for URL Pharma employees, investigating reports of misconduct or compliance violations, and following up with prompt investigation and in some cases, disciplinary action. The HCC is also responsible for coordinating periodic auditing and monitoring for compliance with the Company’s Healthcare Compliance Policies.
Reporting Suspected Violations
Every employee has a duty to report any suspected violation promptly and candidly. In general, you should address the matter within your department or function first with your direct manager, your Healthcare Compliance Committee contact, your Human Resources contact, or the URL Pharma Legal Department. However, you may confidentially report by calling the Compliance Hotline at 888-309-1553. You may provide information to the Hotline with or without identifying yourself.
Non-Retaliation and Open Door Policy
URL Pharma affirmatively protects the rights of its employees to report in good faith any suspected violations of Company policies or applicable law. Employees are strongly encouraged to report such issues through the Company’s internal reporting procedures and may do so anonymously through the Company’s Hotline at 888-309-1553.
Understanding that employees or third parties may be reluctant to report concerns for fear of retaliation, URL Pharma enforces a non-retaliatory environment, making it safe for employees and other stakeholders to raise ethics and compliance concerns in good faith. URL Pharma’s senior management actively supports and strictly enforces the non-retaliation policy. Retaliation against an employee or a third-party for reporting a concern in good faith is prohibited, and will result in discipline, up to and including termination.
Compliance with Applicable Healthcare Laws and Regulations
URL Pharma is committed to full compliance with all applicable laws, regulations, and ethical standards in conducting its marketing, promotional, research, educational and other activities. URL Pharma employees should be familiar with the relevant U.S. federal and state laws and regulations that affect our business. While not an exhaustive list, below are summaries of key laws, regulations, and industry standards that apply to our primary activities. All employees are expected to become familiar with and abide by the commitments URL Pharma has made as part of the Compliance Program.
Federal and State Anti-Kickback Laws
Healthcare treatment decisions should not be motivated by personal gain or enrichment. Federal and state anti- kickback laws prohibit improper influences by making it illegal to pay anything of value to induce someone to purchase, prescribe, or recommend a product that is reimbursed under federal or state government healthcare programs (e.g., Medicare or Medicaid). Some state laws are broader and apply to all items and services, even those not reimbursed under a government program.
FDA Laws and Regulations
The U.S. Food and Drug Administration (FDA) regulates URL Pharma product research, development, manufacture, distribution, and promotion activities. These rules govern all written and verbal communications to prescribers, patients, and other external third parties by URL Pharma employees, affiliates, and agents, including speakers, consultants, and advisors. Generally, these communications must not be false or misleading, lack fair balance of safety and effectiveness information, make unsubstantiated claims, or promote uses not described in the FDA-approved product labeling.
Federal and State False Claim Laws
Federal and state laws prohibit submitting—or causing to be submitted—false claims to government programs or private insurers. California and other states have enacted similar laws modeled after the federal False Claims Act. Examples of sales and marketing activities that might violate these laws include submitting fraudulent claims for government payment, reporting false pricing information to government agencies, and off-label promotion. These laws also provide a means for whistleblower (qui tam) complaints and their protection from retaliation.
Federal and State Privacy Laws
URL Pharma may handle certain personal health information that may be protected by federal and state laws. Company personnel must treat such information carefully and in compliance with privacy laws. These laws include the Health Insurance Portability and Accountability Act of 1996 (HIPAA), among others.
Federal and State Consumer Protection and Licensing Laws
The Federal Trade Commission protects consumers from unfair and deceptive marketing practices and requires that those who endorse products disclose if they have material connections with the seller. Company employees should not use the Internet or other outlets such as blogging to recommend or endorse the Company’s products. In addition, many state laws protect consumers from inappropriate sales and marketing practices, which have been construed to include off-label promotion. Professional licensing laws provide for disciplinary action against practitioners who engage in unprofessional conduct. Although not directed at companies, URL Pharma will not engage in activities that could cause practitioners to violate their professional and ethical obligations.
The Prescription Drug Marketing Act of 1987 (“PDMA”)
The PDMA requires controls and tracking for prescription drug samples. The PDMA was designed to improve the distribution and the dispensing of prescription drug samples by providing a “closed” system for legitimate handlers of these drugs. Such a closed system should reduce the widespread diversion of these samples out of legitimate channels. Under the PDMA, it is a violation to:
- Sell, barter or trade prescription drug samples;
- Deliver prescription drug samples to anyone who is not licensed to prescribe prescription drugs;
- Deliver prescription drug samples to a retail pharmacy;
- Deliver prescription drug samples without a written request from the practitioner.
PhRMA Code on Interactions with Healthcare Professionals
The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted, and recently updated, the PhRMA Code to ensure that pharmaceutical companies’ interactions with healthcare professionals benefit patients and enhance the practice of medicine. Certain state laws require companies to adopt policies that comply with the PhRMA Code.
Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers
The OIG of the U.S. Department of Health and Human Services has issued the Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidelines”) to define the specific elements that pharmaceutical manufacturers should consider when developing and implementing an effective compliance program. The OIG Guidelines addresses the public and private sectors’ mutual goals of preventing and reducing fraud and abuse in federal healthcare programs.
Conflicts of Interest
As employees, our commitment to URL Pharma extends beyond the daily performance of our duties. Any actual or apparent conflict of interest between personal and professional relationships must be avoided. A conflict of interest occurs when a person’s private interest interferes or even appears to interfere with the interests of the Company or our duties to the Company. We must conduct our business and personal affairs in a manner that avoids entering into any situation that creates, or even appears to create, a conflict between the Company and our own self-interest (whether personal or financial). Furthermore, this obligation may also extend to the interests of family members since their activities, in certain circumstances, could also compromise our ability to perform our responsibilities for the Company.
Examples of conflicts of interest:
- Consulting with or employment by a competitor, supplier, or customer of URL Pharma;
- Holding a substantial equity, debt, or other financial interest in any competitor, supplier, or customer;
- Having a financial interest in any transaction involving the purchase or sale by URL Pharma of any products, materials, equipment, services, or property, other than Company-sponsored programs;
- Accepting any cash, gifts, entertainment, or benefits from any competitor, supplier, or customer, unless specifically approved by the President. The only exceptions are certain meals as set forth by the President and items of de minimis value such as pens, note pads and post-it notes that are then used for the benefit of URL Pharma and not used for the benefit of any particular employees.
Conflicts of interest may not always be clear; if you have any questions, you should consult with the URL Pharma Legal Department. If you become aware of a conflict or other potential conflict, you should bring it to the attention of the Legal Department.
Regulation of advertising and promotion directly affects our customer relationships. All URL Pharma employees should understand the basic rules URL Pharma follows to ensure compliance with the laws and regulations regarding promotional activities and interactions with healthcare practitioners.
URL Pharma’s policy is that all promotional materials and communications must be:
- Consistent with FDA-approved product labeling;
- Accurate and not misleading;
- Balanced, substantiated and scientifically rigorous; and
- Compliant with applicable federal and state laws and regulations and applicable policies issued by the Company
Interactions with Healthcare Professionals (HCPs)
URL Pharma strives to ensure that interactions with healthcare professionals (HCPs) are lawful and consistent with the highest standards of ethics and good business practices. To that end, all interactions with HCPs and organizations must be intended to ensure the effective use of our products and to enhance patient care. This can include advancing medical research, enhancing medical knowledge, or gathering necessary feedback about our products.
URL Pharma will engage the services of HCPs and organizations when they are legitimately needed, and will not pay more than an appropriate fair market value for the services provided.
URL Pharma will not enter into business relationships or offer or provide gifts, hospitality, or anything else of value to induce or reward favorable decisions about our products.
URL Pharma employees must always provide information about the Company’s products to healthcare professionals and organizations in accordance with the relevant provisions of this Code and supporting Healthcare Compliance policies.
Health Care-Related Grants and Contributions
URL Pharma employees must never give, offer, or promise anything of value to anyone in order to improperly influence that person or institution regarding the prescribing, recommending, dispensing, promoting, purchasing, placing on a formulary, reimbursing, or facilitating access to URL Pharma products. Educational and charitable funding and other donation requests must be reviewed and responded to in accordance with URL Pharma Healthcare Compliance policies. Only personnel who are authorized may participate in the evaluation process and make decisions regarding the funding of these requests.
Clinical and Regulatory Affairs
URL Pharma products are heavily regulated by governmental agencies. Every employee is responsible for compliance with product regulation requirements, including marketing approvals, good clinical practice requirements, good manufacturing practice requirements, design controls, labeling and advertising controls, and any other product regulations and controls promulgated by government agencies.
Confidential and Proprietary Information
Confidential information is any data which has not been disclosed to the public that you encounter as an employee of the Company. This includes customer lists, marketing or strategic plans, prices, specifics regarding deals offered to individual customers, research reports, and acquisition plans. It also includes business proprietary or trade secret data such as chemical formulas and engineering drawings.
Confidential and business proprietary information are the property of URL Pharma, not of any individual employee, and may only be used to further the interests of URL Pharma. Therefore, you may not disclose confidential or business proprietary information to anyone who does not work within URL Pharma without first receiving the proper authority to do so. This information should be shared with other employees only on a need-to-know basis; you should not share this information with other employees unless they require it to perform their own jobs. Employees are required to sign and comply with the Company’s Employee Proprietary Information and Invention Agreement.
Honesty and Fair Dealing
URL Pharma personnel are expected to deal fairly, honestly and ethically with the Company and its customers, suppliers, competitors, employees, the government and other stakeholders. You should never take advantage of anyone through manipulation, abuse of privileged information, misrepresentation of facts or any other unfair dealing.
Standards of Documentation: Internal Controls
All of URL Pharma’s book, records, accounts, and financial statements must be maintained in reasonable detail, must appropriately reflect URL Pharma’s transactions and conform to applicable legal and accounting requirements and to URL Pharma’s system of internal controls.
All transactions and records shall be documented in a manner that:
- Clearly describes and identifies the nature of business transactions, assets, liabilities, or equity;
- Classifies and records, in a proper and timely manner, accounting entries that conform with generally accepted accounting principles and applicable tax regulations; and
- Accurately records manufacturing, laboratory and clinical data consistent with applicable regulatory requirements.
URL Pharma requires honest and accurate recording and reporting of information in order to make responsible business decisions. All Company financial reports, accounting records, research reports, sales reports, expense accounts, time sheets and other documents must accurately and clearly represent the relevant facts or the true nature of a transaction. Improper or fraudulent accounting, documentation, or financial reporting are contrary to Company policy and may also be in violation of applicable laws. Such violations potentially involve personal liability, both civil and criminal, as well as sanctions against URL Pharma.
URL Pharma is committed to compliance with antitrust and fair competition laws. These laws are designed so that customers enjoy the benefit of open competition among suppliers and sellers benefit from open competition among purchasers. Violation of antitrust laws can lead to civil or criminal liability for corporations and individuals.
These laws are complex, and consequently, employees may not take any collaborative action with a competitor, or take any action that could have an improper anti-competitive effect, without prior advice for URL Pharma Legal Counsel. Examples of prohibited conduct include:
- Agreements or understandings with competitors, either directly or through others, to fix prices, divide customers or territories, or restrict sales;
- Exchange of pricing or other proprietary information with competitors; and
- Illegal tying, illegal price discrimination or refusals to deal.
URL Pharma supports your right to participate actively in the political process. However, solicitations made during work hours or on URL Pharma property on behalf of any political party, candidate committee or other election fund are subject to the Company’s general policy prohibiting solicitations or distributions of literature during working time or in working areas.
No corporate political contributions of any kind shall be made without the approval of the board of Directors and unless in compliance with applicable laws.
No direct or indirect pressure is to be directed toward employees to make any political contribution or support a political party or candidacy of any person.
URL Pharma prohibits its employees or anyone acting on the Company’s behalf from making, offering, or promising any payment or benefit to any person or entity to improperly influence a government official or gain an unfair business advantage.
Federal and state anti-kickback laws prohibit improper influences by making it illegal to pay anything of value to induce someone to purchase, prescribe, or recommend a product that is reimbursed under federal or state government healthcare programs (e.g., Medicare or Medicaid). This is to ensure that a healthcare provider’s treatment recommendation is not motivated or influenced by personal gain.
URL Pharma relies on its network of suppliers to produce quality products for our customers. It is critical that all URL Pharma suppliers share our commitment to conducting business with integrity. When engaging or dealing with a supplier, employees are required to:
- Clearly define requirements and engage in fair and open competition;
- Ensure suppliers are reputable and qualified;
- Ensure the engagement of a supplier does not create an actual or apparent conflict of interest;
- Evaluate and approve suppliers before any materials, components, products or services are purchased from them in accordance with URL Pharma’s Supplier Quality Standard and other requirements;
- Incorporate into any written agreement URL Pharma’s Ethics and Compliance Standards for Suppliers or the supplier’s own ethics and compliance standards when those standards meet URL Pharma’s expectations; and
- Obtain approval from Corporate prior to any public endorsement of a business partner.
URL Pharma does not discriminate at any level on the basis of race, gender, age, ethnicity, national origin, sexual orientation, marital status, disability, or religious beliefs. This ethical standard demands respect for all individuals and consideration of the interests of all those affected by and involved in our business.
Equal Employment Opportunity
It is URL Pharma’s policy to provide equal employment opportunities and to treat applicants and employees without regard to personal characteristics such as race, color, religion, gender, sexual orientation, age, gender identity or gender expression, national origin, marital status, disability, veteran status or other characteristics protected by applicable laws.