Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 54

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 54
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, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk
of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors.
Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the regulations of
the FDA and other similar foreign regulatory authorities, provide true, complete and accurate information to the FDA and other similar
foreign regulatory authorities, comply with manufacturing standards we have established, comply with healthcare fraud and abuse laws
in the United States and similar foreign fraudulent misconduct laws or report financial information or data accurately or to disclose
unauthorized activities to us. If we obtain FDA approval of any of our product candidates and begin commercializing those products in
the United States, our potential exposure under such laws and regulations will increase significantly, and our costs associated with
compliance with such laws and regulations are also likely to increase. These laws may impact, among other things, our current activities
with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular,
the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry,
are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations
may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer
incentive programs and other business arrangements generally. For more information, see the section entitled “Business– Healthcare Laws and Regulations.”

The distribution of biotechnology
and biopharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing,
storage and security requirements intended to prevent the unauthorized sale of biotechnology and biopharmaceutical products.

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The scope and enforcement
of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of
the lack of applicable precedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as responding
to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention
from other aspects of its business.

It is not always possible
to identify and deter employee misconduct, and our code of ethics and the other precautions we take to detect and prevent inappropriate
conduct may