Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1655

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1655
---
 may not prevent the FDA from approving other
competing products.

Regulatory authorities may
designate drugs for relatively small patient populations as “orphan” drugs. Generally, if a product with an orphan drug designation
subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a
period of market exclusivity, which, subject to certain exceptions, precludes the FDA from approving another marketing application for
the same drug for the same indication for that time period. The applicable market exclusivity period is seven years in the United States.

Obtaining orphan drug exclusivity
for our product candidates may be important to our commercial strategy. If a competitor obtains orphan drug exclusivity for and approval
of a product with the same indication as our product candidates before we do, and if the competitor’s product is the same drug or
a similar medicinal product as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity after FDA approval,
we may not be able to maintain it. For example, if 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.

67

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.
According