Compliance
Program

Building a Culture of Integrity: Introduction to Our Compliance Program

At Accord BioPharma, we are committed to conducting business with the highest ethical standards consistent with all applicable laws, rules and regulations.

We have invested significant time and resources to develop the policies, procedures and processes that make up our Comprehensive Compliance Program (the Program). The Program has been designed in accordance with our good faith interpretation of the U.S. Department of Health and Human Services, Office of Inspector General’s (“OIG”) “Compliance Program Guidance for Pharmaceutical Manufacturers” and “General Compliance Program Guidance” published November 2023 (collectively “OIG Compliance Guidance”), the Pharmaceutical Research and Manufacturers of America Code (“PhRMA Code”), and other applicable rules and regulations.

This Program serves as a foundation for our daily decision-making, guiding our interactions with colleagues, clients, and the communities we serve. We further proactively strive to ensure that our employees and contractors adhere to our Program. In the event we become aware of any violations of law or the Program we are committed to investigating and taking appropriate corrective/disciplinary action.

Why is Compliance Important?

Compliance goes beyond simply following rules. It’s about fostering a culture of ethical behavior, minimizing legal and reputational risks, and building trust with stakeholders. Our program ensures we adhere to all applicable laws, regulations, and industry standards.

What Does This Program Encompass?

This program is a comprehensive framework with several key components:

  • Clearly Defined Policies and Procedures: We provide clear, written policies and procedures that guide employee conduct in various situations. These policies cover topics such as anti-corruption, data privacy, financial controls, and workplace safety.
  • Comprehensive Training and Education: We offer ongoing training programs to educate employees at all levels on their compliance obligations. This training equips them to identify and avoid ethical dilemmas.
  • Open Communication Channels: We foster an environment where employees feel comfortable raising concerns or reporting suspected misconduct. This includes a confidential reporting hotline and open communication channels with management.
  • Effective Monitoring and Auditing: We have established processes to regularly monitor and audit our compliance practices. This allows us to identify and address any potential issues proactively.
  • Disciplinary Action and Enforcement: We take a firm stance on non-compliance. Our program outlines a clear disciplinary action process to ensure accountability and deter misconduct.

Benefits of a Strong Compliance Program:

By actively implementing this program, we gain numerous advantages:

  • Reduced Legal and Financial Risk: Compliance helps us avoid costly legal penalties and financial sanctions.
  • Enhanced Reputation: Demonstrating commitment to ethical conduct strengthens our reputation and builds trust with stakeholders.
  • Improved Decision-Making: Clear guidelines ensure ethical and responsible decision-making throughout the organization.
  • Positive Work Environment: A culture of compliance fosters a positive work environment where employees feel secure and valued.

Employee Role in Compliance:

Every employee plays a crucial role in upholding our compliance program. We encourage all employees to:

  • Read and understand our Program thoroughly.
  • Participate in compliance training programs.
  • Raise concerns or report suspected misconduct through the designated channels.
  • Ask questions if you are unsure about the ethical implications of a situation.

This program is a continuous journey. We will periodically review and update it to ensure its effectiveness. Together, we can build a strong foundation of ethical conduct and ensure Accord BioPharma remains a leader in responsible business practices.

California (+)

Annual Declaration of Compliance with California Health and Safety Code §119402

Accord BioPharma (“Company”) hereby declares its commitment to ethical marketing and promotion of its pharmaceutical products in the State of California. This declaration fulfills the requirements set forth in California Health and Safety Code §119402 (SB 1765).

Comprehensive Compliance Program

The Company has established and maintains a Comprehensive Compliance Program (“CCP”) designed to ensure compliance with applicable federal and state laws and regulations governing interactions with healthcare professionals (“HCPs”). This CCP is based on the following guidelines:

  • OIG Guidance: The “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the U.S. Department of Health and Human Services Office of Inspector General (OIG) and the General Compliance Program Guidance published by OIG in November 2023.
  • PhRMA Code: The Pharmaceutical Research and Manufacturers of America’s “Code on Interactions with Health Care Professionals”.

Annual Spending Limit on Gifts and Promotional Items to HCPs

In accordance with the Company’s CCP and consistent with the OIG Guidance and PhRMA Code, the Company has established a specific annual aggregate dollar limit of $2,000 on gifts, promotional materials, or items or activities that the Company may provide to an individual HCP in California.
This limit excludes:

  • Drug samples intended for free distribution to patients.
  • Financial support for independent medical education programs or scholarships for HCPs.
  • Payments for legitimate professional services provided by HCPs, based on fair market value

The Company maintains a system to track and monitor its expenditures related to interactions with HCPs in California to ensure compliance with this annual spending limit.

Availability of the Comprehensive Compliance Program

The provisions of the Company’s CCP are available for review by the public upon request: LegalNotices@intaspharma.com or 1-866-941-7875.

Conclusion

The Company is committed to conducting its business in a manner that complies with all applicable laws and regulations and fosters ethical interactions with HCPs. This Annual Declaration of Compliance serves as a testament to that commitment.