Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 223

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 223
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 by third parties,
exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more
patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others.
Moreover, it is not always clear to industry participants, including us, which patents cover various types of drugs, products or their
methods of use or manufacture. Thus, because of the large number of patents issued and patent applications filed in our fields, there
may be a risk that third parties allege they have patent rights encompassing our product candidates, technologies or methods.

Third parties may assert
that we are employing their proprietary technology without authorization. Generally, conducting preclinical and clinical trials and other
development activities in the United States is not considered an act of infringement. If CER-1236 or another product candidate is cleared/approved
by the FDA, a third party may then seek to enforce its patent by filing a patent infringement lawsuit against us. While we do not believe
that any patent claims that could have a materially adverse effect on the commercialization of our product candidates are valid and enforceable,
we may be incorrect in this belief, or we may not be able to prove it in litigation. In this regard, patents issued in the United States
by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened
standard of proof. There may be issued third-party patents of which we are currently unaware with claims to compositions, formulations,
methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Patent applications can take
many years to issue. There may be currently pending patent applications which may later result in issued patents that our product candidates
may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these
patents. Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable, exhausted,
or not infringed by our activities. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing
process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any final product itself,
the holders of any such patents may be able to block our ability to commercialize the product candidate unless we were to obtain a license
under the applicable patents, or until such patents expire or they are finally determined to