ABB/Con-Cise Optical Group LLC
2025 Annual Declaration of Compliance
California Health and Safety Code 119400-119402
1. Introduction
Purpose of the Declaration

This Annual Declaration of Compliance is crafted to affirm ABB/Con-Cise Optical Group's (ABB) unwavering commitment to ethical conduct and adherence to both state and federal laws, as well as contractual obligations. This declaration specifically addresses compliance with the California Health and Safety Code Sections 119400-119402, which mandates the establishment of a Comprehensive Compliance Program (CCP) for pharmaceutical companies operating within the state. Our declaration serves as a testament to our dedication to maintaining the highest standards of integrity and transparency in all our operations.

Importance of Compliance

Compliance with legal and regulatory requirements is not merely a legal obligation but a cornerstone of our corporate philosophy. It ensures that we operate within the legal frameworks designed to protect public health and safety, foster trust with stakeholders, and uphold our reputation as a responsible corporate entity. By adhering to these standards, we contribute to the broader goal of promoting ethical practices within the pharmaceutical industry.

2. Background Summary
Overview of California's Comprehensive Compliance Program (CCP)

California's Comprehensive Compliance Program (CCP) is a regulatory framework that requires pharmaceutical companies to establish and maintain a compliance program that aligns with the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. California law also requires that CCPs include a specific dollar limit on gifts, promotional materials, and items or activities that companies may provide to an individual medical or health care professional. The CCP is designed to prevent, detect, and address violations of law, regulations, and company policies, thereby promoting an ethical culture within the organization.

Summary of California Health and Safety Code 119400-119402

The California Health and Safety Code Sections 119400-119402, often referred to as the "California Compliance Law," mandates that pharmaceutical companies adopt a CCP that is consistent with federal guidelines. This law requires companies to implement measures that ensure compliance with applicable laws and regulations, particularly those related to the marketing and promotion of pharmaceutical products. The code emphasizes the importance of transparency, accountability, and ethical conduct in all business practices.

3. Corporate Compliance Program Overview
Structure and Implementation

ABB's Corporate Compliance Program is structured to ensure comprehensive oversight and effective implementation of compliance measures across all levels of the organization. The program is overseen by a dedicated Compliance & Privacy Officer, supported by a Compliance Committee, which includes representatives from key departments such as legal, finance, and operations. This structure ensures that compliance is integrated into the fabric of our corporate culture.

Key Policies and Procedures

Our compliance program is underpinned by a robust set of policies and procedures designed to guide employee conduct and decision-making. These include:

  • Code of Conduct: A comprehensive document outlining the ethical standards and expectations for all employees.
  • Anti-Bribery and Corruption Policy: Measures to prevent and address bribery and corruption in all business dealings.
  • Data Privacy and Security Policy: Protocols to safeguard sensitive information and ensure compliance with data protection laws.
  • Whistleblower Policy: Mechanisms for employees to report unethical behavior without fear of retaliation.
4. Seven Essential Elements of OIG's Effective Compliance Program
Element 1: Standards and Procedures

We have established clear standards and procedures that define acceptable conduct and ensure compliance with applicable laws and regulations. These standards are communicated to all employees and are regularly reviewed to ensure relevance and effectiveness.

Element 2: Oversight Responsibilities

Our Compliance Officer, supported by the Compliance Committee, is responsible for overseeing the implementation and effectiveness of the compliance program. This includes regular reporting to the Board of Directors and senior management.

Element 3: Education and Training

We provide comprehensive education and training programs to ensure that all employees understand their compliance obligations. Training sessions are conducted regularly and are tailored to address specific compliance risks relevant to different roles within the organization.

Element 4: Monitoring and Auditing

We conduct regular monitoring and auditing activities to assess compliance with our policies and procedures. These activities are designed to identify potential compliance issues and ensure timely corrective action.

Element 5: Reporting and Investigation

We have established a confidential reporting system that allows employees to report suspected violations of law or company policy. All reports are thoroughly investigated, and appropriate action is taken to address any confirmed violations.

Element 6: Enforcement and Discipline

We enforce our compliance standards through a consistent disciplinary process that addresses violations of law or company policy. Disciplinary actions are proportionate to the severity of the violation and are applied consistently across the organization.

Element 7: Response and Prevention

We are committed to responding promptly to identified compliance issues and implementing measures to prevent their recurrence. This includes revising policies and procedures, enhancing training programs, and strengthening internal controls.

5. Attestation Statement
Commitment to Compliance

ABB hereby attests to its commitment to maintaining a comprehensive compliance program that aligns with the requirements of the California Health and Safety Code Sections 119400-119402 and all other applicable laws and regulations. We are dedicated to fostering an ethical culture and ensuring that our business practices reflect the highest standards of integrity.

Assurance of Adherence to Laws

We assure all stakeholders that we adhere to all applicable state and federal laws, as well as contractual obligations. Our compliance program is designed to prevent, detect, and address any violations, thereby safeguarding the interests of our stakeholders and the public.

6. Conclusion
Summary of Compliance Efforts

In conclusion, ABB remains steadfast in its commitment to ethical conduct and compliance with all applicable laws and regulations. Our comprehensive compliance program is a testament to our dedication to maintaining the highest standards of integrity and transparency in all our operations. For more information regarding ABBs compliance program please contact us by:

Phone:1-800-852-8089
Email: PrivacyOfficer@abboptical.com

Future Compliance Goals

Looking ahead, we are committed to continuously enhancing our compliance program to address emerging risks and regulatory changes. We will continue to invest in training, monitoring, and auditing activities to ensure that our compliance efforts remain effective and aligned with best practices.

This Annual Declaration of Compliance reflects our ongoing commitment to ethical conduct and compliance with the California Health and Safety Code Sections 119400-119402, as well as all other applicable laws and regulations.