Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1640

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1640
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. We expect to have to negotiate budgets and contracts
with CROs, trial sites and CDMOs which may result in delays to our development timelines and increased costs. We will rely heavily on
these third parties over the course of our clinical trials and we control only certain aspects of their activities. As a result, we have
less direct control over the conduct, timing and completion of these clinical trials and the management of data developed through clinical
trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that each
of our studies is conducted in accordance with applicable protocol, legal and regulatory requirements and scientific standards and our
reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with
GCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in
clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators
and trial sites. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in our
clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional
clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities will
determine that any of our clinical trials comply with the GCP regulations. In addition, our clinical trials must be conducted with biological
product produced under cGMP regulations, including current good tissue practice (“cGTP”) regulations, and will require a large
number of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient
number of patients may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business
may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare
privacy and security laws.

58

Any third parties conducting
our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with such third
parties, we cannot control whether or not they devote sufficient time and resources to our product candidates. These third parties may
also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials
or other drug development activities, which could affect their performance on our behalf. If these third parties do not