Orphan Poland

Code of Conduct

Introduction

At Orphan Poland sp. z o.o. ("Orphan Poland" or the "Company"), we are committed to conducting our business with the highest ethical standards. As a company dedicated to supporting patients with rare diseases, we value integrity, transparency, responsibility, and care in everything we do.

This Third Party Code of Conduct (the “Code”) sets out the expectations we have of our external partners, including suppliers, vendors, agents, subcontractors, co-promote partners and other third parties (collectively referred to as “Third Party Representatives”). Compliance with this Code is a condition for initiating and maintaining business relationships with Orphan Poland.

General Responsibilities

Third Party Representatives are expected to:

  • Operate in full compliance with applicable laws, regulations, and ethical standards
  • Respect privacy and confidentiality
  • Maintain safe, fair, and inclusive workplaces
  • Act with honesty and integrity in all business dealings
  • Support environmental sustainability and human rights

Business Conduct & Ethics

Anti-Bribery/Anti-Corruption (ABAC):

Orphan Poland maintains a zero-tolerance policy toward bribery and corruption. Third Party Representatives must never engage in bribery, facilitation payments, or kickbacks—whether dealing with public officials or private individuals. Compliance with applicable anti-corruption and anti-money laundering laws, including but not limited to the U.S. FCPA and the UK Bribery Act, is mandatory.

Antitrust and Fair Competition:

Third Party Representatives must comply with antitrust and competition laws in all jurisdictions where they operate. Business must be conducted fairly and without unlawful collusion or market manipulation.

Business and Financial Records:

All financial records must be accurate, complete, and maintained in compliance with applicable laws. Invoices must reflect actual transactions, be supported by documentation, and not be manipulated to avoid review or approval procedures.

Confidentiality:

Third Party Representatives must protect confidential and proprietary information of Orphan Poland and not disclose it without prior written authorization.

Intellectual Property:

Respect for intellectual property rights is essential. Third Party Representatives must protect both Orphan Poland’s IP and that of other entities (e.g., patents, trademarks, copyrights, trade secrets).

Marketing and Promotional Practices:

All marketing and promotional materials must be truthful, evidence-based, and in compliance with applicable laws. The use of Orphan Poland’s name, trademarks, or product references requires prior written consent.

Data Privacy:

Third Party Representatives must comply with all applicable privacy and data protection laws. They are required to implement adequate safeguards to protect personal information against unauthorized access, disclosure, or misuse.

Subcontractors:

Partners must ensure that their subcontractors and supply chain also adhere to the standards set forth in this Code. Appropriate due diligence and oversight mechanisms must be in place.

Trade Sanctions, Export Controls, and Competition:

Third Party Representatives must comply with relevant trade laws, including EU, U.S., and Swiss sanctions and export control regulations. Business practices should promote fair competition and avoid abuse of dominant positions.

Quality Standards & Assurance

Orphan Poland expects all products and services provided by Third Party Representatives to meet mutually agreed-upon quality standards and to comply with Good Distribution Practices (GDP), relevant ISO standards, and applicable national regulations.

Third Party Representatives must operate under a quality management system and ensure appropriate communication with Orphan Poland regarding compliance, deviations, and improvements.

Labor Standards

Third Party Representatives must:

  • Prohibit forced labor, human trafficking, and involuntary work
  • Avoid child labor and only employ young workers under safe, legal conditions
  • Ensure fair wages, benefits, and working hours aligned with local law
  • Provide a workplace free of discrimination, harassment, and abuse
  • Respect workers' rights to association and collective bargaining

Health, Safety, and Environment

Worker Health and Safety:

Third Party Representatives must ensure:

  • Hazard information and training are provided to workers
  • Systems are in place to identify, assess, and control workplace risks
  • Proper emergency preparedness and response plans exist
  • Safe working environments free from chemical, biological, or physical hazards

Environmental Stewardship:

Partners must:

  • Comply with environmental laws and obtain necessary permits
  • Minimize waste, emissions, and environmental impact
  • Promote resource efficiency and sustainability (e.g., water, energy)
  • Have systems in place to prevent and mitigate environmental incidents

Management System

Third Party Representatives must implement and maintain management systems to ensure ongoing compliance with this Code, including:

  • Commitment of adequate resources and leadership to ethical practices
  • Risk assessment and internal control processes
  • Proper financial documentation and controls (e.g., no “off-the-books” records)
  • Allowing audits or assessments by Orphan Poland when reasonably requested
  • Training employees on ethics and compliance standards

Reporting Concerns

If you suspect any unethical behavior or potential violation of this Code, please report it to: compliance@orphanpoland.pl. Reports may be made anonymously. Orphan Poland is committed to confidentiality and non-retaliation for good faith disclosures.