Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 204

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 204
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 may be subject to state laws that
require pharmaceutical companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance
guidelines, state laws that require drug and biologics manufacturers to report information related to payments and other transfers of
value to physicians and other healthcare providers or marketing expenditures, as well as state and foreign laws governing the privacy
and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA. Additionally,
to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty
exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. In the United States
and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part,
on the extent to which third-party payors provide coverage, and establish adequate reimbursement levels for such drug products. In the
United States, third-party payors include federal and state healthcare programs, government authorities, private managed care providers,
private health insurers and other organizations.

Third-party payors are increasingly
challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical drug products and medical services,
in addition to questioning their safety and efficacy. Such payors may limit coverage to specific drug products on an approved list, also
known as a formulary, which might not include all of the FDA-approved drugs for a particular indication. We may need to conduct expensive
pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs
required to obtain the FDA approvals. Nonetheless, our product candidates may not be considered medically necessary or cost-effective.
Moreover, the process for determining whether a third-party payor will provide coverage for a drug product may be separate from the process
for setting the price of a drug product or for establishing the reimbursement rate that such a payor will pay for the drug product. A
payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further,
one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for
the drug product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize
an appropriate return on our investment in product development.

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