Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 17

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 17
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 commercialize our approved products on a timely basis, or at all.

In
addition, these contract manufacturers are engaged with other companies to supply and manufacture materials or products for such companies,
which also exposes our suppliers and manufacturers to regulatory risks for the production of such materials and products. As a result,
failure to meet the regulatory requirements for the production of those materials and products may also affect the regulatory clearance
of a contract supplier’s or manufacturer’s facility. If the FDA or a comparable foreign regulatory agency does not approve
these facilities for the supply or manufacture of our clinical assets, or if it withdraws its approval in the future, we may need to
find alternative supply or manufacturing facilities, which would negatively impact our ability to develop, obtain regulatory approval
of, or market our clinical assets, if approved. 

39

If
any of our third-party contractors terminate their involvement in the supply, manufacture, or distribution of clinical drug supplies
for us for any reason, we may not be able to enter into arrangements with alternative third party-contractors, or do so on commercially
reasonable terms. In addition, if our relationship with such third-party contractors is terminated, we may experience a negative impact
to the respective licenses on which we rely and, therefore, on our ability to obtain regulatory approval for, or commercialize, our clinical
assets when expected or at all.

Our
reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access to their
facilities, will have access to and may misappropriate our trade secrets or other proprietary information.

In
addition, the manufacturing facilities of certain of our suppliers are located outside of the U.S. This may give rise to difficulties
in importing our products or clinical assets or their components into the U.S. or other countries as a result of, among other things,
regulatory agency approval requirements or import inspections, incomplete or inaccurate import documentation, or defective packaging.

We
currently rely on agreements with third parties for the purpose of licensing our clinical assets. In the near-term, we intend to rely
on third parties for the licensing of clinical assets and those which may arise through future partnerships.

We
currently rely on agreements with third parties for the purpose of licensing clinical assets from large pharmaceutical companies. For
example, we have agreements with AstraZeneca pursuant to which we license clinical assets from AstraZeneca. If we are in breach of the
agreements, the termination of such agreement(s) could materially