Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 15

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 15
---
 connection with such services. If these relationships and any related compensation result in perceived
or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be questioned by the FDA.

38

We
rely completely on third-party contractors to supply, manufacture, and distribute clinical drug supplies for our clinical assets, including
certain sole-source suppliers and manufacturers. We intend to rely on third parties for commercial supply, manufacturing, and distribution
if any of our clinical assets receive regulatory approval and we expect to rely on third parties for supply, manufacturing, and distribution
of preclinical, clinical, and commercial supplies of any future clinical assets.

We
do not currently have, nor do we plan to acquire, the infrastructure or capability to supply, manufacture, or distribute preclinical,
clinical, or commercial quantities of drug substances or products. Our ability to develop our clinical assets depends and our ability
to commercially supply our products will depend, in part, on our ability to successfully obtain the raw materials and APIs and other
substances and materials used in our clinical assets from third parties and to have finished products manufactured by third parties in
accordance with regulatory requirements and in sufficient quantities for preclinical and clinical testing and commercialization. If we
fail to develop and maintain supply relationships with these third parties, we may be unable to continue to develop or commercialize
our clinical assets.

We
rely and will continue to rely on certain third parties as the sole source of the materials they supply or the finished products they
manufacture. Any of our existing suppliers or manufacturers may:

    ●
    fail
    to supply us with product on a timely basis or in the requested amount due to unexpected damage to or destruction of facilities or
    equipment or otherwise;

    ●
    fail
    to increase manufacturing capacity and produce drug product and components in larger quantities and at higher yields in a timely
    or cost-effective manner, or at all, to sufficiently meet our commercial needs;

    ●
    be
    unable to meet our production demands due to issues related to their reliance on sole-source suppliers and manufacturers;

    ●
    supply
    us with product that fails to meet regulatory requirements;

    ●
    become
    unavailable through business interruption or financial insolvency;

    ●
    lose
    regulatory status as an approved source;

    ●
    be
    unable or unwilling to renew current supply agreements when such agreements expire on a timely basis, on acceptable terms or at all;
    or