Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 81

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 81
---
 a competitive product that is the same drug or a similar medicinal product as our
product candidate is shown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained will not
block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that
is the same drug as our product candidates if the FDA finds that we cannot assure the availability of sufficient quantities of the drug
to meet the needs of the persons with the disease or condition for which the drug was designated. If one or more of these events occur,
it could have a material adverse effect on our company.

<div align='center'>40</div>

We are subject to stringent and changing privacy laws, regulations and standards as well as policies, contracts and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to enforcement or litigation (that could result in fines or penalties), a disruption of clinical trials or commercialization of products, reputational harm, or other adverse business effects.

In the ordinary course of
business, we will collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of,
transmit and share (collectively, processing) personal data and other sensitive information, including, but not limited to, proprietary
and confidential business information, trade secrets, intellectual property, and information we collect about patients in connection
with clinical trials. Accordingly, we are, or may become, subject to numerous federal, state, local and international data privacy and
data security laws, regulations, guidance, and industry standards as well as external and internal privacy and data security policies,
contracts and other obligations that apply to our processing of personal data and the processing of personal data on our behalf.

In the United States,
federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws,
personal data privacy laws, consumer protection laws and other similar laws (e.g., unfair or deceptive acts or practices pursuant to
Section 5(a) of the Federal Trade Commission Act). For example, HIPAA, as amended by the Health Information Technology for
Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, imposes requirements relating
to the privacy, security and transmission of protected health information. Among other things, HITECH, through its implementing regulations,
makes certain of HIPAA’s privacy and security standards directly applicable to business associates, defined as a person