Part of Cytokinetics’s value of We > Me includes maintaining an effective and comprehensive corporate compliance program. Cytokinetics has adopted a compliance program to address areas covered by the May 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”), which was developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”). The OIG Guidance provides insight to manufacturers in the development, design and definition of scope of an effective compliance program.
Cytokinetics’s Comprehensive Compliance Program may be referred to as our “Compliance Program” throughout this description. Our Compliance Program applies to our officers and employees in their activities on behalf of Cytokinetics.
Our Compliance Program’s purpose is to assist Cytokinetics in maintaining compliance with the laws, regulations, directives, and guidance that apply to our products, to train our employees on these matters, and to prevent, detect, and correct instances of non-compliance. Cytokinetics expects that our officers, employees and agents will comply with all applicable Cytokinetics directives, policies, and guidance, as well as the related laws, regulations, and health plan program requirements. In the event that Cytokinetics becomes aware of non-compliance, we will investigate the matter and, where appropriate, take disciplinary action, up to and including employee termination, and implement corrective measures to prevent future non-compliance.
Cytokinetics’s Compliance Program is described below. Our Compliance Program is dynamic; we intend to regularly review and modify our Compliance Program to meet our evolving compliance needs. Accordingly, the Compliance Program may be amended or revised by Cytokinetics from time to time.
1. Leadership and Structure
Cytokinetics’s Chief Compliance Officer has overall responsibility for oversight of Cytokinetics’s Compliance Program. This includes oversight of the development and operation of the Compliance Program. The Chief Compliance Officer has been vested with the authority relating to compliance within the organization and shall exercise independent judgment concerning these matters. In this role, the Chief Compliance Officer reports to the Chief Executive Officer and the Board of Directors, and they are responsible for overseeing the healthcare compliance policies and program.
2. Written Standards
Cytokinetics has adopted the Company’s U.S. Pharma Code of Conduct which helps to guide our daily operations and reflects the unique business and regulatory environment in which we operate. Our U.S. Pharma Code of Conduct reflects our consideration of the OIG Guidance.
Annual Spending Limit
Cytokinetics also has established guidance regarding appropriate interactions with health care professionals. It is Cytokinetics’s policy to comply with the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals,” dated September 2023, which includes limits on gifts, meals and other activities with health care professionals.
For purposes of complying with the California Health and Safety Code 119402, Cytokinetics has established, commencing January 1, 2026, a maximum annual dollar limit of $2,000 for allowable transfers of value such as meals incident to an appropriate engagement, promotional materials or activities provided to California health care professionals. This limit is exclusive of certain other permissible transfers of value, such as clinical trial payments or certain other associated honoraria. This dollar limit represents a spending cap, and typically the amount spent per physician is anticipated to be substantially less than this maximum amount. Waiver of the limit requires the approval of the Chief Compliance Officer.
On occasion, Cytokinetics may provide medically-relevant and patient-oriented items to HCPs that conform to the PhRMA Code. Some examples include anatomical models, patient education charts or patient friendly information that is useful for patients in understanding or managing their condition and/or treatment.
3. Education and Training of Cytokinetics Staff
A critical element of our Compliance Program is education and training. Cytokinetics is committed to implementing programs to effectively and timely communicate our directives and guidance to affected personnel. New personnel will receive compliance training as part of their initial onboarding and existing personnel are expected to receive compliance training on at least an annual basis. Moreover, Cytokinetics will review and update its training programs periodically, as well as identify additional areas of training on an ongoing basis.
4. Internal Lines of Communication
We expect Cytokinetics employees, officers and directors to promptly report suspected, planned or actual violations of our directives and guidelines and/or laws which govern our commercialization activities. We encourage reports to be made to a supervisor, manager, or directly to the Chief Compliance Officer. If these individuals are not available or if the reporter prefers, reports of violations, including those from outside the company, may be made on an anonymous basis via EthicsPoint, Cytokinetics’s Compliance and Ethics toll-free phone line. EthicsPoint is available 24 hours a day, 7 days a week by calling toll-free in the US (800) 789-5095. Reports may also be made online and global toll-free access numbers are available at cytokinetics.ethicspoint.com.
We encourage our employees, officers, and agents to ask questions about any activity where they are unclear about a potential violation or application of our Compliance Program. Questions may be posed through any of the established channels.
Cytokinetics has a strict no-retaliation policy. Any employee, officer, or agent who raises a compliance concern (potential, suspected, planned or actual violation) will not be retaliated against for raising that good faith compliance concern.
5. Auditing and Monitoring
The Chief Compliance Officer develops the plan for auditing and monitoring the Cytokinetics’s Compliance Program and the implementation of related directives and guidelines. Auditing and monitoring is designed to identify potential or existing areas of concern and to apply corrective action measures appropriately.
6. Responding to Potential Violations
The Chief Compliance Officer, or their designee, also oversees the review of non-compliance reports, incidents, and investigations. When deemed necessary, the Chief Compliance Officer, or a designee, will conduct an investigation into potentially non-compliant activity to determine whether a violation of Cytokinetics’s directives and guidelines has occurred.
7. Corrective Action Procedures
The Chief Compliance Officer is accountable for overseeing corrective and preventative actions in response to non-compliance with Cytokinetics’s policies, procedures, and guidelines. Corrective actions will take into account any reviews, auditing, and monitoring and may include appropriate and consistent disciplinary action (up to and including termination), assessing whether enhancements should be made to our policies, practices, training, or internal controls, and taking action to prevent future non-compliance.
Cytokinetics is committed to compliance and continually strives to monitor and improve compliance with respect to Cytokinetics’s directives and guidelines.
Declaration
As part of Cytokinetics’s continuing commitment to corporate compliance, Cytokinetics declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code sections 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. As of the date of this declaration, Cytokinetics believes it is in compliance with its Compliance Program in all material respects.
Consistent with Cytokinetics’s understanding of the California statute, this declaration is limited to those activities undertaken by Cytokinetics that are directed to California. Cytokinetics makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design, and definition of the scope of compliance programs.
Copies of this declaration and the Compliance Program may be obtained by emailing [email protected] or calling (650) 554-9945.
Dated: January 1, 2026