Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 180

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 180
---
 financial condition and increase our costs and expenses. Our ability to obtain clinical supplies of our product candidates could be
disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.

Our employees, 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.

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