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Compliance

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Declaration Under Cal. Health & Safety Code §§ 119400-119402

CMP Pharma is committed to compliance with applicable regulations and authorities in the promotion, distribution and marketing of its products. In order to achieve these goals, CMP Pharma has implemented a Comprehensive Compliance Program (CCP) consistent with Cal. Health & Safety Code § § 119400-119402, based on its good faith understanding of the statutory requirements.

As recommended in the OIG Guidance, CMP Pharma’s CCP has been tailored to the unique characteristics and needs of the Company. While the OIG Guidance recognizes that even an effective compliance program may not completely eliminate all misconduct by individuals, CMP Pharma’s CCP is designed to prevent and detect violations. CMP Pharma’s expectation is that all employees will adhere to company policies with regard to Federal and state regulations and will implement disciplinary and corrective actions when misconduct is identified.

In accordance with California requirements, CMP Pharma has established an annual spending limit of two thousand dollars ($2,000) per California licensed Health Care Professional (HCP) and intends to monitor employee activities to ensure compliance. Additionally, CMP Pharma’s CCP is available to individuals who request it by contacting [email protected] or 1-800-227-6637.

CMP Pharma’s CCP includes annual audits and assessments for purposes of this declaration. This declaration is being made on 15 August 2024 for calendar year 2024.

CMP Third Party Code of Conduct

Purpose

This Code of Conduct outlines the standards and expectations for third-party service providers providing services to or on behalf of CMP (“Service Providers”). It is designed to ensure ethical behavior and compliance with applicable laws.

Compliance with Laws and Regulations

Service Providers must comply with all applicable federal laws, regulations, and guidelines, including but not limited to those governing business in the pharmaceutical industry, anti-competitive behavior, and interactions with healthcare providers.

Ethical Business Practices

Service Providers are expected to conduct their business with integrity and transparency. This includes:

  • Avoiding conflicts of interest;
  • Prohibiting any form of bribery or corruption; and
  • Ensuring accurate and truthful communication in all business dealings.

Human Rights and Labor Practices

The Service Provider commits to identifying, preventing, and mitigating any risks of human rights violations, including child labor, human trafficking, and forced labor, within its operations and supply chain. The Service Provider shall ensure compliance with applicable laws and international standards, maintain transparent and ethical labor practices, and collaborate with the CMP to address and remediate any identified issues promptly. Regular monitoring, due diligence, and corrective actions are expected to uphold these commitments and promote a responsible supply chain.

Interactions with Healthcare Providers

Interactions with healthcare providers must be conducted ethically, in compliance with federal regulations, and in alignment with the PhRMA Code for Interactions with Healthcare Providers. Service Providers should:

  • Follow established processes for interacting with healthcare providers;
  • Ensure that any engagement with healthcare providers is transparent and documented; and
  • Avoid any actions that could be perceived as influencing medical decisions improperly.

Confidentiality and Data Protection

Service Providers must take reasonable steps to protect the confidentiality of sensitive information, including patient data and proprietary information of CMP. This includes:

  • Implementing appropriate security measures to safeguard data;
  • Complying with all relevant data protection laws and regulations; and
  • Adhering to any terms and conditions of confidentiality or nonuse in place with CMP.

Anti-Competitive Behavior

Service Providers must avoid any actions that could be considered anti-competitive. Laws regulating competition and trade practices vary around the world, but certain activities, such as price fixing or agreeing with a competitor to allocate customers, are almost always illegal. Third parties must understand and ensure compliance with all competition and trade practices laws or restrictions that apply in connection with their business activities.

REPORTING AND ACCOUNTABILITY

Service Providers are required to report any violations of this Code of Conduct or applicable laws which may impact CMP. This includes:

  • Establishing mechanisms for reporting unethical behavior; and
  • Cooperating with any investigations into reported violations.

Service Providers may choose to report concerns to the CMP Compliance Hotline through any of the following paths:

  • https://report.syntrio.com/cmppharma
  • English-speaking USA and Canada: 866-694-6966
  • Spanish-speaking USA and Canada: 800-216-1288
  • [email protected] (Please indicate that the report is being made in connection with CMP.)

TRAINING AND AWARENESS

Service Providers must ensure that their employees and representatives are aware of and trained in this Code of Conduct. This includes:

  • Regular training sessions on ethical business practices and compliance requirements; and
  • Providing resources and support for employees to understand and adhere to the Code.

MONITORING AND ENFORCEMENT

Compliance with this Code of Conduct will be monitored, and any violations will be addressed promptly. This includes:

  • Regular audits and assessments of compliance; and
  • Implementing corrective actions for any identified violations.

SANCTIONS AND WATCHLISTS

By providing services to or on behalf of CMP, Service Provider represents and warrants that it, its owners, directors, officers, employees, contractors, and agents are not currently, and will not during the term of this Agreement become:

  • Listed on any sanctions, exclusion, debarment, or watch lists maintained by any U.S. federal agency or authority, including but not limited to:
    • The Office of Foreign Assets Control Specially Designated Nationals and Blocked Persons List;
    • The System for Award Management Excluded Parties List;
    • The Department of Health and Human Services Office of Inspector General List of Excluded Individuals/Entities;
    • The Food and Drug Administration Debarment List; or
    • Any other similar list maintained by a U.S. federal agency.
  • Excluded, debarred, suspended, or otherwise ineligible to participate in federal healthcare programs, federal procurement or non-procurement programs, or pharmaceutical industry activities.

CONCLUSION

Adherence to this Code of Conduct is applicable to Service Providers for CMP. By following these guidelines, Service Providers will contribute to a fair, ethical, and compliant business environment.

 

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