Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 215

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 215
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 distribute any product candidates for which we obtain marketing approval.
In addition, we may be subject to physician payment transparency laws and patient privacy and security regulation by the U.S. federal
government and by the states and foreign jurisdictions in which we conduct our business. For more information, see the section of this
report titled “Business – Healthcare Laws and Regulations.”

Because of the breadth of
these laws and the narrowness of their exceptions and safe harbors, it is possible that our business activities can be subject to challenge
under one or more of such laws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current
environment of healthcare reform. Federal and state enforcement bodies have continued their scrutiny of interactions between healthcare
companies and healthcare providers, which has led to a number of significant investigations, prosecutions, convictions and settlements
in the healthcare industry.

Efforts to ensure that our
internal operations and future business arrangements with third parties will comply with applicable healthcare laws and regulations will
involve substantial costs. If our operations are found to be in violation of any of these laws or any other governmental regulations that
may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages,
monetary fines, imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare
programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations
if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment
or restructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy. If
any of the physicians or other healthcare providers or entities with whom we expect to do business, including future collaborators, are
found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions
from participation in government healthcare programs, which could also affect our business.

72

If we fail to comply with environmental,
health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse
effect on the success of our business. 

We are subject to numerous
environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage,
treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including