I. Introduction
Knoa Pharma LLC and its subsidiaries (the “Company”) are committed to establishing and maintaining an effective pharmaceutical compliance program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). Our Ethics & Compliance Program is a key component of our commitment to the highest standards of pharmaceutical corporate responsibility.
The purpose of our Ethics & Compliance Program is two-fold: to prevent, detect, and remediate violations of law, regulations, and/or Company policies, and to promote a culture of the highest ethics within the organization. It is our Company’s expectation that employees will comply with our Code of Ethics (the “Code”) and supporting policies, as well as our Healthcare Law Compliance Policies and our Injunction. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be eliminated. If the Company becomes aware of violations of laws, regulations, the terms of our Injunction, or our Company policies, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
The fundamental elements of our Ethics & Compliance Program are listed below. As called for in the HHS-OIG Guidance, we have tailored our Ethics & Compliance Program to fit the unique environment of our organization. Moreover, our Ethics & Compliance Program is dynamic; we regularly review and enhance our Ethics & Compliance Program to meet our organization’s evolving compliance needs.
Our Company is committed to conducting business in a lawful and ethical manner. We do not tolerate human rights abuses within our own business operations, and we expect all of our business partners, including suppliers, to engage in sound human rights practices, to treat workers fairly and with dignity and respect.
II. Overview of Ethics & Compliance Program
- Leadership and Structure.
- Vice President, Chief Compliance Officer. Margaret K. Feltz is our Vice President, Chief Compliance Officer, and serves as the primary contact for compliance activities. We strive to ensure that Ms. Feltz has the ability to exercise independent judgment and effectuate change within the organization as needed. Ms. Feltz has the responsibility of developing, operating, and monitoring the Ethics & Compliance Program. She reports to the Company’s Chief Legal Officer, is a member of the Company’s Executive Committee, and has direct access to both the Company’s Chief Executive Officer and the Audit Committee of the Board of Directors.
- Compliance Committees. We have established an Enterprise Compliance and Risk Management (ECRMC) Committee to advise the Vice President, Chief Compliance Officer and assist in the implementation of the Ethics & Compliance Program. This ECRMC and other working groups meet regularly to identify and manage areas of risk and critical focus for our organization.
- Written Standards.
- The Company’s Code of Ethics is our statement of ethical and compliance principles guiding our daily operations. The Code establishes our expectation that management, employees, and certain agents of the Company act in accordance with all laws, regulations, and Company policies. The Code articulates our fundamental principles and values, providing a framework for action within our organization.
- We have published our Healthcare Law Compliance Policies to help address industry compliance risks and to train our employees to act in accordance with these policies.
- We have established annual spending limits for certain promotional activities directed toward healthcare professionals (“HCPs”)who prescribe or may influence prescribing in California. At the present time our annual spending limit is $1000.00 per HCP. Examples of items that fall within this spending limit are infrequent, modest, in-service meals for HCPs and their staff; infrequent, modest meals in connection with product specific and non-product educational programs; and items of use to HCPs in their practice or to their patients. This amount does not include cash payments or honoraria paid to HCPs pursuant to contracts for bona fide consulting or other services. Our Company does not and will not provide any item of value to any HCP with the intent of influencing that HCP’s prescribing habits.
- Education and Training. A critical element of our Ethics & Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable state and federal healthcare programs. Our Company will effectively communicate our standards and procedures and will regularly review and update our training programs.
- Internal Lines of Communication. Our Company actively fosters dialogue among management and employees. Our goal is that all employees should know who to turn to when seeking answers to questions or reporting possible Code violations and should be able to do so without fear of retaliation. To that end, we have adopted open-door policies, as well as confidentiality and non-retaliation policies. We have a confidential, toll-free Integrity Helpline (1-877-787-3831) through which employees and persons outside of our Company may report any concerns or suspected violations of law, regulation, Company policies or our Injunction.
- Auditing and Monitoring. Our Ethics & Compliance Program includes efforts to monitor, audit, and evaluate adherence to compliance policies and procedures. In accordance with the HHS-OIG Guidance, the nature, extent, and frequency of our compliance monitoring and auditing may vary according to new regulatory requirements, changes in business practices, and other considerations.
- Responding to Potential Violations. Our Company sets forth clear, disciplinary consequences of violating a law or Company policies. While each situation will be considered on a case-by-case basis, we will utilize disciplinary action to address inappropriate conduct and deter future violations.
- Corrective Action Procedures. A compliance program increases the likelihood of identifying and preventing unlawful and unethical behavior. However, HHS-OIG recognizes that even an effective compliance program may not prevent all violations. As such, our Ethics & Compliance Program requires us to respond promptly to potential violations of law, regulation, our Injunction, and/or Company policies. Then we can assess whether the violation is due to gaps in our policies, practices, or internal controls, take appropriate disciplinary action, and work to prevent future violations.
Declaration Clause for California, as of July 1, 2025
Our Company hereby declares that to the best of its knowledge and based on our good faith understanding of the statutory requirements, we have established a Comprehensive Compliance Program (CCP) compliant with the requirements of California Health and Safety Code §§ 119400-119402. The Company is committed to conducting our business according to the highest ethical standards. While we cannot eliminate the possibility that an individual employee will violate these standards, our Ethics & Compliance program is reasonably designed to detect and prevent violations of state and federal laws as well as our own internal policies and procedures. As of July 1, 2005, the above-referenced compliance program was in place, and we are continually reassessing our Ethics & Compliance Program to improve it.