Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 199

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 199
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 application to market a similar medicinal product for the same indication 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 profitable not to justify maintenance of market exclusivity. Additionally, an MA may be granted
to a similar medicinal product for the same indication as an authorized orphan product at any time if:

| ● | the second applicant can establish that its product,                                                   
 although similar to the authorized product, is safer, more effective or otherwise clinically superior; |

| ● | the MA holder of the authorized product consents to 
 a second orphan medicinal product application; or   |

| ● | the MA holder of the authorized product cannot supply 
 enough orphan medicinal product.                      |

A pediatric investigation
plan (“PIP”) in the European Union is aimed at ensuring that the necessary data are obtained to support the authorization
of a medicine for children, through studies in children. All applications for MAs for new medicines have to include the results of studies
as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when an MA
holder wants to add a new indication, pharmaceutical form, or route of administration for a medicine that is already authorized and covered
by intellectual property rights. Several rewards and incentives for the development of pediatric medicines for children are available
in the European Union. Medicines authorized across the European Union with the results of studies from a PIP included in the product
information are eligible for an extension of their supplementary protection certificate (“SPC”) by six months (provided
an application for such extension is made at the same time as filing the SPC application for the product, or at any point up to two years
before the SPC expires). This is the case even when the studies’ results are negative. For orphan medicinal products, the incentive
is an additional two years of market exclusivity. Scientific advice and protocol assistance at the EMA are free of charge for questions
relating to the development of pediatric medicines. Medicines developed specifically for children that are already authorized but are
not protected by a patent or supplementary protection certificate are eligible for a pediatric-use MA (“P