Mahana Therapeutics, Inc. (“Mahana”) develops digital treatments for people living with chronic health conditions. Our mission at Mahana is to provide clinically validated and FDA cleared programs that offer expanded access and individualized therapy to empower all patients seeking to manage chronic conditions, such as IBS.
Mahana’s Code of Ethics and Conduct (“Code”) reflects our commitment to conducting business with high standards of ethical behavior. The Code is applicable to all personnel at Mahana and its affiliates. All directors, officers, employees and contractors (“personnel”) are expected to act with integrity and to make ethical decisions consistent with the Code.
Mahana is committed to establishing and maintaining an effective compliance and ethics program that promotes conducting business with integrity and complying with the laws applicable to Mahana and its operations. Our compliance and ethics program is based on the elements described in the "Compliance Program Guidance for Pharmaceutical Manufacturers" issued by the Office of Inspector General of the U.S. Department of Health and Human Services (the "OIG Guidance"), the U.S. Department of Justice’s “Evaluation of Corporate Compliance Programs” (the “DOJ Guidance”), and the "Code of Ethics on Interactions with Healthcare Professionals" issued by the Advanced Medical Technology Association (“AdvaMed Code”).
Mahana’s compliance and ethics program is designed, implemented and operated with the goal of preventing, detecting and responding to potential or actual instances of non-compliance. All Mahana personnel are required to comply with the Code, company policies, and applicable laws. However, as acknowledged by the OIG Guidance, the implementation of a comprehensive compliance program does not guarantee that there will be no misconduct. If Mahana becomes aware of potential violations of law, the Code or company policy, the matters will be investigated. As appropriate, disciplinary and corrective actions will be implemented to prevent future violations. Additionally, Mahana continuously assesses the effectiveness of its compliance program to enable it to implement necessary adjustments or refinements to the program.
Following is an overview of Mahana’s comprehensive compliance and ethics program which will be reviewed and updated periodically to meet changing regulatory, legal and compliance requirements.
Leadership and Oversight
Mahana has a Chief Compliance Officer who is responsible for developing, operating, and monitoring the compliance and ethics program. The Compliance Officer reports directly to the CEO. Mahana’s Compliance Officer has the ability to effectuate change within the organization and to exercise independent judgment.
The Compliance Officer works closely with leaders on the Regulatory, Finance, Human Resources, Privacy and Security teams (collectively, “Compliance Leadership”) to provide leadership and support for the company’s compliance and ethics program, assist Mahana’s leadership team in managing the compliance and ethics program, and to provide assistance and guidance in assessing and verifying the effectiveness of the compliance and ethics program to promote our ethical business culture and compliant operating environment. These leaders use various tools and workflows to oversee and communicate regarding Mahana’s comprehensive compliance and ethics program.
In addition to the Code, Mahana is developing and implementing compliance policies and procedures to help ensure compliance with applicable laws and to support ethical decision-making. These policies and procedures are being developed under the direction and supervision of the Chief Compliance Officer and the Compliance Leadership. Mahana’s written standards address the key areas of potential risk for medical device manufacturers identified in the OIG Guidance. All Mahana personnel and representatives are required to adhere to the company’s policies and procedures.
Mahana’s relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Informational presentations and discussions by company representatives and others speaking on behalf of Mahana provide valuable scientific and educational benefits. In connection with such presentations or discussions, Mahana may offer occasional meals and items designed primarily for the education of patients and healthcare professionals in accordance with the AdvaMed Code.
With respect to business activities in California, Mahana has established "a specific annual dollar limit on educational items and promotional activities [personnel] may give or otherwise provide to an individual medical or healthcare professional." Mahana has established an annual maximum dollar limit of $1,000, effective as of January 1, 2022. Mahana will evaluate this limit on an annual basis and make any necessary adjustments consistent with any operational or practical issues related to compliance with the statute. The annual limit does not include expenditures for the following:
Financial support for continuing medical education programs
Financial support for health educational scholarships
Payments for legitimate professional services, and any meals or expenses associated with the provision of such services
Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition
Education and Training
All Mahana commercial employees in the U.S. receive appropriate compliance training which includes education on the OIG Guidance, the AdvaMed Code, anti-kickback laws and anticorruption, the federal False Claims Act, and requirements related to product promotion, privacy, conflicts of interest, and other applicable federal, state, and industry rules and guidelines. Mahana will regularly review and revise its compliance training and seek to identify new areas of training that may be needed to educate employees on compliance matters and the laws and requirements applicable to Mahana.
Internal Lines of Communication
Mahana encourages open communication and maintains an open reporting environment. The company has adopted and reinforces its policy against retaliation. Mahana’s Code and policies require employees to report any actual or suspected violations of the Code, company policies or applicable law. Each reported matter will be appropriately investigated and addressed. Personnel can raise concerns or report potential misconduct in a number of ways including managers and Compliance Leadership or the third-party operated reporting tool. Personnel may raise concerns without fear of retaliation. In addition, Mahana’s Compliance team will use an internal website on which compliance-related policies, guidance and information can be found.
Auditing and Monitoring
Mahana only recently initiated its first commercial product launch. In the near future, its comprehensive compliance and ethics program includes an auditing and monitoring plan to assess whether policies and procedures which address compliance risk areas have been implemented and communicated and are followed. The areas for monitoring and auditing are being reviewed and will be updated over time to reflect evolving compliance concerns, new regulatory requirements, changes in business practices, and other considerations. The results of auditing and monitoring activities will be considered in adapting and improving existing compliance policies, procedures and training.
Responding to Potential Violations
Personnel are required to adhere to the Code and company policies. Any violations can subject an employee to serious disciplinary measures, including possible termination of employment. Although the disciplinary and corrective actions for each situation will be determined on a case-by-case basis, Mahana will seek to ensure consistent and appropriate disciplinary and corrective actions are taken in response to violations.
Mahana will conduct investigations of potential violations of the Code and company policies in accordance with its written investigations and corrective action protocol to ensure timely, complete, and objective investigations. In accordance with the OIG and DOJ Guidances, the exact nature and level or thoroughness of the internal investigation will vary according to the circumstances. Once an internal investigation is completed, corrective action and preventative measures are determined and implemented as appropriate.
This description is effective as of January 1, 2022. Mahana will assess its compliance program at least annually, for the purpose of declaring compliance with California Health and Safety Codes §§ 119400-119402.
California Declaration of Compliance
Mahana Therapeutics, Inc. (“Mahana”) is committed to establishing and maintaining an effective compliance and ethics program that promotes conducting business with integrity and complying with the laws applicable to Mahana and its operations. Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Mahana hereby declares that, to the best of its knowledge, as of January 1, 2022, Mahana is in material compliance with its comprehensive compliance and ethics program and the requirements of the California Health & Safety Code §§ 119400-119402. It is Mahana’s expectation that all employees and representatives comply with its compliance and ethics program and all policies that support this program. Mahana is committed to assessing ongoing compliance with its compliance program, which is designed to prevent, detect and respond to potential or actual instances of non-compliance.
A copy of this Declaration may be obtained by contacting Mahana at firstname.lastname@example.org.