Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 147

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 147
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 1, 2025. This new framework fundamentally changes the previous system under
the Northern Ireland Protocol, including with respect to the regulation of medicinal products in the United Kingdom. In particular, the
MHRA is now responsible for approving all medicinal products destined for the United Kingdom market (i.e., Great Britain and Northern
Ireland), and the EMA no longer has any role in approving medicinal products destined for Northern Ireland under the European Union centralized
procedure. A single United Kingdom-wide MA will be granted by the MHRA for all novel medicinal products to be sold in the United Kingdom,
enabling products to be sold in a single pack and under a single authorization throughout the United Kingdom. In addition, the new arrangements
require all medicines placed on the UK market to be labelled “UK only”, indicating they are not for sale in the European Union.

The MHRA has introduced changes
to national licensing procedures, including procedures to prioritize access to new medicines that will benefit patients, an accelerated
assessment procedure and new routes of evaluation for novel products and biotechnological products. On January 1, 2024, the MHRA put in
place an international recognition framework under which the MHRA may have regard to decisions on the approval of MAs made by the EMA
and certain other regulators when determining an application for a new Great Britain MA.

There is now no pre-MA orphan
designation in the UK. Instead, the MHRA reviews applications for orphan designation in parallel to the corresponding MAA. The criteria
are essentially the same, but have been tailored for the UK market, i.e., the prevalence of the condition in UK (rather than the European
Union) must not be more than five in 10,000. Should an orphan designation be granted, the period or market exclusivity will be set from
the date of first approval of the product in the UK.

32

Healthcare Laws and Regulations

Sales of our product candidate,
if approved, or any other future product candidate, will be subject to healthcare regulation and enforcement by the federal government
and the states and foreign governments in which we might conduct our business. The healthcare laws and regulations that may affect our
ability to operate include the following:

●The federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully,
directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business,
including the purchase, order, lease of