Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 178

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 178
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 current Good Manufacturing Practice (“cGMP”) requirements.

Lentivirus containing CER-1236
will be produced following a cGMP process using cGMP plasmids.

We have entered into a contract
manufacturing agreement related to the production of drug product for our clinical trials, and we anticipate entering into similar arrangements
regarding plasmid, viral vector and final drug product manufacture for drug product to be used in subsequent clinical trial phases in
the future. We intend to advance related process development work both internally and with our contract manufacturing organization (“CMO”)
partners. In the event a product candidate receives regulatory approval, we anticipate entering into contract manufacturing agreements
with one or more CMOs to support product launch and commercial manufacture.

Intellectual Property

Intellectual property is
of vital importance in our field and in biotechnology generally. Our commercial success will depend in part on obtaining and maintaining
patent protection for our current and future product candidates. We seek to protect and enhance proprietary technology, inventions, and
improvements that are commercially important to the development of our business by seeking, maintaining, and defending our patent rights.
When available to expand market exclusivity, our strategy is to obtain or license additional intellectual property related to current
or contemplated development platforms, core elements of technology, and/or clinical candidates. We will also seek to rely on regulatory
protection afforded through inclusion in expedited development and review, data exclusivity, market exclusivity, and patent term extensions,
where available. In addition to patent protection, we also may rely on trademark registration, trade secrets, know-how, other proprietary
information, and continuing technological innovation to develop and maintain our competitive position. We seek to protect and maintain
the confidentiality of proprietary information to protect aspects of our business that are not amenable to, or that we do not consider
appropriate for, patent protection.

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The term of individual patents
depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, including
the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the
United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative
delays by the U.S. Patent and Trademark Office (“USPTO”) in examining and granting a patent, or may be shortened if
a patent is termin