Corporate Compliance & Policy Statement

American Regent, Inc. has implemented a Corporate Compliance Program developed based on the fundamental elements described in the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidance”). Our Corporate Compliance Program is a key component of our commitment to the highest standards of corporate conduct. The Corporate Compliance Program is reasonably designed to foster compliance with applicable laws and regulations; the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (“PhRMA Code”); and other requirements relevant to our business.
The fundamental elements of our Corporate Compliance Program are described in greater detail below. Because our Corporate Compliance Program is dynamic, we review and enhance the Corporate Compliance Program to meet evolving compliance standards.

1. Compliance Officer & Compliance Committee 
American Regent, Inc. has a Chief Ethics & Compliance Officer responsible for implementing, operating, and monitoring the Corporate Compliance Program. American Regent, Inc. also has established a Corporate Ethics & Compliance Committee charged with assisting the Chief Ethics & Compliance Officer and overseeing the operation of the Corporate Compliance Program.

2. Written Standards 
American Regent, Inc.’s US Standards of Business Conduct is our statement of ethical and compliance principles that guide our daily operations. The US Standards of Business Conduct and the Standards of Business Conduct to& Ethics for Third Parties also establish our expectation that management, employees, vendors, contractors, and agents of American Regent, Inc. act in accordance with applicable laws, regulations, guidelines, and company policies and procedures. The US Standards of Business Conduct is supplemented by policies, procedures and other guidelines that address compliance risk areas, including areas identified in the OIG Guidance and PhRMA Code.

Standards of Business Conduct (SOBC) PDF 

Standards of Business Conduct & Ethics for Third Parties

3. Education and Training
American Regent, Inc. is committed to communicating our standards, policies, procedures, and guidelines to our employees. We provide education and training to new and current employees on a variety of compliance-related topics. Training programs are updated periodically, and additional areas of training are added from time to time.

4. Internal Lines of Communication
American Regent, Inc. is committed to fostering open communication between management and our employees, vendors, contractors, and agents. To that end, American Regent, Inc. has contracted with an independent third party to operate a confidential hotline available to all employees, vendors, customers, contractors, agents and the public designed to encourage them to ask questions or report concerns without fear of retaliation or retribution. The number is 1-877-48-ALERT or reports can be made at ari.ethicspoint.com. American Regent, Inc. also encourages employees to bring questions or concerns directly to their manager, Human Resources, the Legal Affairs Department, or the Corporate Compliance Department.

5. Auditing and Monitoring 
American Regent, Inc. reviews and assesses business activities for compliance with applicable laws, regulations, guidelines, and company policies and procedures. Corrective action plans are developed to address concerns identified through these reviews.

6. Disciplinary Guidelines 
American Regent, Inc. takes disciplinary action in response to violations of applicable laws, regulations, guidelines and company policies and procedures. Disciplinary action may include warnings, suspension, termination, and other sanctions, as appropriate.

7. Corrective Action
American Regent, Inc. responds appropriately to address issues that are identified or reported. Appropriate corrective action may be taken, including disciplinary action, training, and improvement of policies and procedures.

CALIFORNIA HEALTH & SAFETY CODE §§ 119400-119402 
American Regent, Inc. has established an annual dollar limit of $2,500.00 for applicable spending on individual health care professionals licensed by the state of California in accordance with California Health & Safety Code §§ 119400-119402. This dollar limit represents a spending maximum and not an average or goal. American Regent, Inc. reserves the right to change this limit at any time.

For a copy of our Corporate Compliance Program and/or annual written declaration of compliance with California Health & Safety Code §§ 119400-119402, please call 1-800-398-1496.

JULY 1, 2025 DECLARATION OF COMPLIANCE WITH CALIFORNIA HEALTH & SAFETY CODE §§ 119400-119402
To our knowledge and based on our good faith understanding of the statutory requirements, American Regent, Inc. declares that it complies in all material respects with our Corporate Compliance Program and the requirements of California Health & Safety Code §§ 119400-119402.

California Transparency in Supply Chains Act:

Corporate Disclosure in Compliance with SB 657 California Transparency in Supply Chains Act (Human Trafficking and Anti-Slavery)

The California Transparency in Supply Chains Act (the “Act”) requires large retailers and manufacturers doing business in California to disclose on their websites their “efforts to eradicate slavery and human trafficking from [their] direct supply chain for tangible goods offered for sale.” The Act applies to any company (defined as retail sellers or manufacturers) doing business in the State of California that has annual worldwide gross receipts of more than $100 million dollars (U.S.).

While American Regent, Inc. has its own Policies and Procedures that cover the Act, we fall under the jurisdiction of our parent company, Daiichi Sankyo, Inc., which discloses its Daiichi Sankyo Group Human Rights Policy.

Verification: All new vendors must complete a Human Rights questionnaire. Our existing vendors will complete this questionnaire retroactively.

Auditing: We institute a risk-based audit program to evaluate supplier compliance with our Company’s standards for labor and human rights.

Certification: Beyond requiring suppliers to abide by the Standards of Business Conduct and Ethics for Third Parties (all required vendor users and new required vendor users as part of the mandatory compliance training) and complete the Human Rights questionnaire, we do not currently require any additional certifications.

Internal Accountability: At our Company, all employees are responsible for: 1) adhering to the values and standards set forth in our own U.S. Standards of Business Conduct (SOBC); 2) complying with all relevant Company polices; and 3) raising compliance concerns. Employees may raise concerns to their supervisor, Human Resources, Legal or Corporate Compliance. They are also encouraged to Speak Up at ari.ethicspoint.com to report concerns. We investigate all reported allegations of misconduct. Violations of the SOBC or policies may result in a variety of corrective actions and in some cases may result in disciplinary action up to and including termination of employment.

Training: We train all employees on the SOBC through a series of compliance training courses. We also provide training on how to evaluate, escalate and mitigate potential supplier risks for labor and human rights to those that have responsibility for supplier selection and management.

Vendor Resources

American Regent Policies for Third Parties

View American Regent Polices and related documents.