Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 202

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 202
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 European Union will enact legislative measures to bring it into law. On June 9, 2023, the MHRA announced that the
medicines aspects of the Windsor Framework will apply from January 1, 2025.

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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 a new 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 Great Britain. 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 Great Britain market, i.e., the prevalence of the condition in Great
Britain (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 Great Britain or the European Union, wherever is earliest.

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 any good, 
 facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. The term    
 “remuneration” has been broadly interpreted to include anything of value;                                                             |

| ● | Federal false claims, and                                                                                                               
 false statement laws, including the federal civil False Claims Act, and Civil Monetary Penalties Law, prohibits, among other things,    
 any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval