Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 144

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 144
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 by the EMA to be a new active substance, and products may
not qualify for data exclusivity. Even if 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 is granted, 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 application to market a similar medicinal product for the same indication as the authorized
orphan product for a period of ten years. A “similar medicinal product” is defined as a medicinal product containing a similar
active substance or substances as contained in an authorized orphan medicinal product, and which is intended for the same therapeutic
indication. The exclusivity period may be reduced to six years if, at the end of the fifth year, it is shown that the designation criteria
are no longer met, including where it is shown that the product is sufficiently