California Declaration
Jaeger Medical Comprehensive Compliance Program and Compliance Declaration
Jaeger Medical is committed to doing business in accordance with the highest standards of business conduct and ethics. Jaeger Medical’s Compliance Program reflects our commitment to compliance with the laws and regulations that apply to our business, including the California Health and Safety Code §§ 119400‐119402 (the “California Act”).
I. INTRODUCTION
Our Compliance Program is organized around the seven elements of an effective compliance program as set forth in the voluntary standards “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Services (“HHS‐OIG Guidance”). Our Compliance Program also incorporates voluntary industry guidelines, including the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”). Our Compliance Program is tailored to Jaeger Medical’s size, organizational structure, available resources, and the nature of our business as a medical device manufacturer.
The purpose of our Compliance Program is to prevent and detect violations of law or company policy. The HHS‐OIG Guidance recognizes that the implementation of such a program cannot guarantee the complete elimination of improper employee conduct. Jaeger Medical’s expectation, however, is that employees will comply with our Code of Conduct and our policies established in support of such Code. Jaeger Medical will investigate any violation of law or company policy and where appropriate take disciplinary action and institute measures to avoid future violations. The following is a description of Jaeger Medical’s Compliance Program.
II. DESCRIPTION OF COMPLIANCE PROGRAM
A. Leadership and Structure
Our Compliance Program was established by our Board of Directors in conjunction with Jaeger Medical Senior Leadership. The VP, Chief Compliance Officer is responsible for the management and operation of the Compliance and Ethics Department and the development and ongoing enhancement of the compliance program. The VP, Chief Compliance Officer makes regular reports to the Compliance Committee of the Board of Directors.
Jaeger Medical’s executive Compliance and Ethics Committee supports the Compliance Program and assists in preventing, detecting, and reacting to instances of non‐compliance.
B. Written Standards
Jaeger Medical’s Code of Conduct and compliance policies provide a guide of individual and collective obligations for responsible business conduct. Our Code of Conduct is a foundational document outlining our policies and providing the ethical framework to guide our business operations in accordance with law and company policies. The Code of Conduct applies to all Jaeger Medical employees and each of our key business partners working on our behalf. It specifically provides a clear and consistent standard to do our jobs in a manner which reflects Jaeger Medical’s values and serves our shared purpose. Among other important topics, our compliance policies address potential risk areas for medical device organizations to implement our high ethical standards and meet our healthcare compliance obligations under applicable laws and regulations. These policies apply to all employees and compliance with these policies is a condition of employment.
C. Training and Education
Jaeger Medical’s Compliance Program is supported by ongoing education and training of our employees on Jaeger Medical’s Code of Conduct and compliance policies. Training and education programs for employees increase their awareness of our Code’s guidelines and the legal and ethical implications of their actions and behaviors. New employees receive compliance training as part of their initial training, and Jaeger Medical provides ongoing compliance training and updates for its existing employees. Jaeger Medical will regularly review and update its training programs, and identify additional areas of compliance training as appropriate. All employees are required to train on Jaeger Medical’s Code of Conduct annually.
D. Communication
Jaeger Medical is committed to maintaining a work environment where all individuals encourage and embrace open discussion across both geographical and operational boundaries. Employees are encouraged to seek guidance in resolving compliance and ethics questions. They are required to report suspected or actual unethical or non‐compliant conduct, violations of law or regulation, and violations of internal company policies. Jaeger Medical maintains a reporting hotline which allows anonymous reporting of suspected or actual noncompliance without retaliation.
E. Auditing and Monitoring
Jaeger Medical self‐assesses and will periodically audit its compliance with its policies and procedures to identify and address potential issues and opportunities to enhance its processes and practices.
F. Investigating and Responding to Potential Violations
Our Compliance and Ethics Department monitors company functions and activities for potential violations of law, regulation, the Code of Conduct and company policies. Potential violations are promptly and thoroughly investigated and appropriate corrective action taken.
G. Corrective Action
In determining the appropriate response to an established violation, Jaeger Medical considers various options for corrective action. These options include remediation to evaluate current practices and close any gaps in policies, practices or training that may have led or contributed to the violation, as well as the imposition of disciplinary action up to and including termination.
III. CALIFORNIA ACT DECLARATION
In accordance with the California Act, Jaeger Medical has established a specific annual dollar limit of $1,500, which applies to promotional materials, items, and activities provided by an employee of Jaeger Medical to covered recipients in California. In addition, the following expenses are excluded from the limit: expenses that are directly associated with payments statutorily excluded from the limit (e.g., meals for consultants), items provided to health care professionals that are ultimately intended for patients or consumers, and receptions at third party educational or professional meetings.
To the best of its knowledge and based upon our good faith understanding of the statutory requirements, Jaeger Medical declares that it is in all material respects in compliance with the requirements of the California Act.
A copy of this description of Comprehensive Compliance Program and Compliance Declaration may be obtained by calling 1‐833‐327‐3284.
Information for California Residents:
The CCPA provides consumers (California residents) with specific rights regarding their personal information. This section describes your CCPA rights and explains how to exercise those rights.
- Right to know – Consumers may request that businesses disclose what personal information is collected, used, shared or sold by the business, in both categories and specific pieces of information;
- Right to delete — Consumers may request that a business delete the consumer’s personal information held by both the business and by extension, the business’s service providers;
- Right to opt-out — Consumers may direct a business to cease the sale of the consumer’s personal information. As required by the law, businesses must provide a “Do Not Sell” information link on their websites or mobile apps;
- Rights for minors regarding opt-in consent — Children under the age of 16 must provide opt-in consent, with a parent or guardian consenting for children under 13; and
- Right to non-discrimination — Businesses may not discriminate against consumers in terms of price or service when a consumer exercises a privacy right under CCPA.
Emailing us at: privacy@jaegerrdx.com
Contacting us at the following address:
Leibnizstrasse 7
97204 Hoechberg, Germany
Last Updated: June 2025