Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 13

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 13
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 associated with our clinical assets
could result in injury to a patient or even death. We cannot offer any assurance that we will not face product liability suits in the
future, nor can we assure investors that our insurance coverage will be sufficient to cover our liability under any such cases. In addition,
a liability claim may be brought against us even if our clinical assets merely appear to have caused an injury. Product liability claims
may be brought against us by consumers, health care providers, pharmaceutical companies, or others selling or otherwise coming into contact
with our clinical assets, among others. If we cannot successfully defend ourselves against product liability claims, we will incur substantial
liabilities and reputational harm. 

37

We
currently rely on, and expect to continue to rely on, third-party CROs and other third parties to conduct and oversee our clinical trials
and other aspects of product development. If these third parties do not meet our requirements or otherwise conduct the trials as required,
we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize, our clinical assets when
expected or at all.

We
have in the past relied and expect to continue to rely on third-party CROs to conduct and oversee our clinical trials and other aspects
of product development. We also rely upon various medical institutions, clinical investigators, and contract laboratories to conduct
our trials in accordance with our clinical trial protocols and all applicable regulatory requirements, including the FDA’s regulations
and GCPs, which are an international standard meant to protect the rights and health of patients and to define the roles of clinical
trial sponsors, administrators and monitors, and state regulations governing the handling, storage, security, and recordkeeping for drug
and biologic products. These CROs and other third parties play a significant role in the conduct of these trials and the subsequent collection
and analysis of data from the clinical trials. We rely heavily on these parties for the execution of our clinical trials and preclinical
studies, and control only certain aspects of their activities. We, our CROs, and other third-party contractors are required to comply
with GCP, GLP, and GACP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities
for products in clinical development. Regulatory authorities enforce these GCP, GLP, and GACP requirements 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,