Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 198

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 198
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 may be referenced, but no medicinal product
can be marketed until the expiration of the market exclusivity. The overall ten-year period will be extended to a maximum of eleven years
if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications
which, during the scientific evaluation prior to authorization, is held to bring a significant clinical benefit in comparison with currently
approved therapies. There is no guarantee that a product will be considered by the EMA to be a new chemical entity, and products may
not qualify for data exclusivity. Even if a product is considered to be a new chemical entity so that the innovator gains the prescribed
period of data exclusivity, another company could nevertheless also market another version of the product if such company obtained an
MA based on an MAA with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials.

The criteria for designating
an “orphan medicinal product” in the European Union are similar in principle to those in the United States. Under Article 3
of Regulation (EC) 141/2000, a medicinal product may be designated as an orphan medicinal product if it is intended for the diagnosis,
prevention, or treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 persons
in the European Union when the application is made. In addition, orphan designation can be granted if the product is intended for a life
threatening, seriously debilitating, or serious and chronic condition in the European Union and, without incentives, it is unlikely that
sales of the product in the European Union would be sufficient to justify the necessary investment in its development. Orphan designation
is only available if there is no other satisfactory method approved in the European Union of diagnosing, preventing, or treating the
applicable orphan condition, or if such a method exists, the proposed orphan medicinal product will be of significant benefit to patients
affected by such condition, as defined in Regulation (EC) 847/2000.

Orphan designation provides
opportunities for fee reductions, protocol assistance, and access to the centralized procedure. Fee reductions are limited to the first
year after an MA, except for small and medium enterprises. In addition, if a product which has an orphan designation subsequently receives
a centralized MA for the indication for which it has such designation, the product is entitled to orphan market exclusivity, which means
the EMA may not approve any other