supplier code of conduct
Effective Date: April 15, 2024
INTRODUCTION
The success of FHI Clinical Inc. is built on excellence, and on its high ethical standards that reflect its values. FHI Clinical is committed to conducting business ethically and expects that services provided by its suppliers, subcontractors, vendors, and consultants (hereinafter “Suppliers”) will be conducted in compliance with all applicable laws, rules, and regulations and with the standard of care customary in the contract research organization industry.
This Supplier Code of Conduct (hereinafter the “Code”) sets out FHI Clinical’s standards of ethical behavior and professional conduct expectations for all FHI Clinical Suppliers.
CODE COMPLIANCE AND ENFORCEMENT
Upholding the values reflected in this Code is crucial to the success of FHI Clinical’s work. Unethical conduct undermines our ability to do, support and facilitate high quality research that impacts our participants and advances science. The documented breach of any one of these principles may result in remediation actions up to, and including, termination for material breach.
BUSINESS INTEGRITY
Business and Financial Records
Suppliers are expected to maintain accurate records of their business and financial activities. Such records should be compliant with all applicable laws, regulations, and contract requirements. Suppliers shall ensure adequate internal controls and processes are in place to comply with its obligations under this section.
Anti-Corruption
It is the policy of FHI Clinical to conduct every business transaction with the highest regard for moral and ethical business practices and business integrity. All Suppliers must ensure that their conduct is in strict compliance with both the letter and the spirit of the laws and regulations that apply to FHI Clinical. FHI Clinical is committed to full compliance with the letter and spirit of the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act and other national, federal, state, and local laws in all jurisdictions in which FHI Clinical procures supplies or services. All Suppliers of FHI Clinical shall refrain from any acts that are prohibited by any applicable anti-corruption laws and the FCPA. Suppliers suspecting violations must report their concerns to the FHI Clinical Point of Contact (POC) noted in this Code.
Anti-Trafficking
FHI Clinical supports the global fight to end human trafficking in all forms, and as such, has adopted a zero-tolerance policy on human trafficking. FHI Clinical complies with, and requires all of its Suppliers to comply with, the requirements outlined in FAR 52.222-50 – Combating Trafficking in Persons (48 CFR 52.222-50). FHI Clinical will include appropriate language reflecting the applicable requirements in Supplier contracts, subcontracts, and subawards. If any Supplier fails to comply with applicable requirements, FHI Clinical will take appropriate action, up to and including termination of Supplier contract for material breach, to remediate the violation and prevent future violations.
Debarment
Suppliers must not at any time use, in any capacity, in connection with the supply of its goods and/or performance of its services, the services of any person debarred or proposed for debarment under 21 U.S.C. § 335(a) or (b); or Subsection 306(a) or (b) of the Federal Food, Drug and Cosmetic Act, otherwise disqualified or suspended from performing clinical research studies, excluded from participation in any Federal health care program or otherwise subject to any restrictions or sanctions by the U.S. Food & Drug Administration or any other regulatory authority or professional body with respect to the performance of scientific or clinical investigations.
Suppliers will not use any person in any capacity to perform any services for FHI Clinical if such person appears on any Government Restriction Lists, including the OIG “List of Excluded Individuals/Entities” and the U.S. General Service Administration “Excluded Parties List System”. Suppliers shall screen all personnel that work on FHI Clinical clinical trials to ensure compliance with the above requirements. Confirmation of these processes shall be made available upon reasonable request by FHI Clinical.
Wages, Benefits, and Working Hours
Suppliers shall pay workers according to applicable employment laws, including minimum wages, overtime hours and mandated benefits. Working hours for employees will not exceed the maximum set by applicable law or regulation.
Supplier Fraud and/or Theft
FHI Clinical has a zero tolerance policy with respect to certain acts that threaten the safety and security of staff, the integrity of the organization, or represent a breach of trust. Acts of theft and fraud against FHI Clinical, its partner organizations or clients affect the integrity of the organization, and any act of theft or fraud will be addressed promptly and, if proven, will be considered a material breach of contract terms. Acts of theft or fraud are not only violations of FHI Clinical policy but are criminal offenses and may also be reported immediately to the appropriate authorities as applicable. Suppliers doing business with FHI Clinical have an obligation to interact honestly in the provision of their services to FHI Clinical and to report allegations of fraud and/or theft.
Supplier Third Party Providers
Suppliers are expected to require their third-party providers to comply with all relevant terms and conditions in Supplier’s contract and the principles set forth in this Supplier Code of Conduct.
PROFESSIONAL STANDARDS
Clinical Trials
When Suppliers are directly engaged in providing goods and services for FHIC clinical trials, all relevant Supplier conduct must be in accordance with the global standards of Good Practices (i.e., Clinical, Laboratory/Clinical Laboratory, Manufacturing, etc.), applicable local regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Conflicts of Interest
A potential conflict of interest exists when a Supplier’s interests interfere with or are contrary to the interests of FHI Clinical. In all dealings with or on behalf of FHI Clinical, Suppliers may not, under any circumstances, allow their interests to adversely affect or interfere with FHI Clinical’s interests.
Acceptance of Gifts
FHI Clinical selects and does business with suppliers and other parties based on objective performance and business criteria. Suppliers are not to provide or offer any material gifts, favors or hospitality that might influence or give the appearance of influencing FHI Clinical’s decision making or compromise their judgment in actions affecting FHI Clinical. No gift, favor, hospitality, or entertainment should be provided or offered if it will create a feeling of obligation, compromise judgment, or appear to improperly influence a business relationship.
FHI Clinical Confidential Information
Suppliers are responsible for appropriately protecting confidential or proprietary information belonging either to FHI Clinical or entrusted to it by third parties. Such information may include work product, trade secrets, research, program and other technical information, pricing policies, business plans, budgets, employee information, and information entrusted to FHI Clinical by third parties. Suppliers receiving confidential information from FHI Clinical are required to sign non-disclosure agreements before information is exchanged.
Harassment-Free Workplace
FHI Clinical believes that all employees are entitled to work in an environment free from harassment, intimidation, and coercion, allowing each employee to reach their full potential. Suppliers shall ensure employees are treated fairly by providing a workplace that is free from any form of harassment based on race, color, religion, sex, pregnancy, national origin, disability, age, sexual orientation, gender identity, veteran status, genetic information or other characteristic or activity protected by federal, state or local law. Maintenance of a harassment free workplace is an expectation of all suppliers regardless of the geographic areas in which they operate.
ENVIRONMENTAL, HEALTH AND SAFETY
FHIC expects Suppliers to provide a healthy and safe working environment, and to be environmentally responsible to minimize any adverse impacts of operations on the environment.
Emergency Management Plan
Suppliers shall have an Emergency Management Plan in place in the event of an emergency. The Emergency Management Plan shall include appropriate processes in place to identify, prevent and mitigate any risk of an event that would pose a threat to worker safety and/or to the environment and the actions to be taken should such an event occur.
Business Continuity/Disaster Recovery
Suppliers shall have a Business Continuity/Disaster Recovery (BC/DR) Plan in place so that, if an unforeseen event occurs which impacts Supplier’s ability to conduct ongoing business operations, such BC/DR Plan may be immediately implemented to minimize disruptions to the Supplier and its customers, including FHI Clinical. The plan shall include appropriate processes to identify, prevent, and/or mitigate any risk of an event that would pose a threat to continued business operations should such an event occur. The primary objective of this Disaster Recovery Plan is to ensure the continued operation of identified business critical systems (see Critical Systems list) in the event of a disaster. Specifically, this plan should: limit the extent of disruption and damage, minimize the economic impact of the interruption, establish alternative means of operation in advance, train personnel in emergency procedures, provide for smooth and rapid restoration of service, and minimize interruptions to normal operations.
Management Systems
Suppliers are required to have appropriate and effective management systems to ensure compliance with applicable legal requirements and demonstrate adherence to this Code.
REPORTING AND INVESTIGATION CODE VIOLATIONS
If Suppliers have information that they, their employees, suppliers or subcontractors have possible violations of this Code, they are required to provide prompt written notice to the point of contact listed below. Suppliers who violate this Code are subject to disciplinary action that may include suspension or termination of FHI Clinical’s relationship with Supplier. A substantiated breach of this Code shall be considered a material breach of contract terms and may be subject to immediate termination for cause. In addition, certain Code violations may also violate applicable laws and regulations. Suppliers who commit such offenses may be subject to fines, penalties, and criminal or civil liability.
Questions or Notices should be directed to:
FHI Clinical
Attn: Christopher Mikaelian
Global Head, Contracts & Legal Affairs
359 Blackwell Street, Suite 200
Durham, NC 27701
Email: cmikaelian@fhiclinical.com
With a copy to: Legal@fhiclinical.com
