Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 82

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 82
---
 for our drug candidates must meet applicable cGMP requirements to the FDA’s or comparable international
regulatory authorities’ satisfaction before any product is approved and our commercial products can be manufactured. We rely, and
expect to continue to rely, on third parties for the production of clinical and commercial quantities of our candidates in accordance
with cGMP regulations. These manufacturers must comply with cGMP regulations that require, among other things, quality control and quality
assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers
and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the
FDA and certain state agencies and are subject to periodic prescheduled or unannounced inspections by the FDA and certain state agencies
for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production
and quality control to maintain cGMP compliance. Future inspections by the FDA and other regulatory agencies may identify compliance issues
at the facilities of our contract manufacturing organizations (“CMOs”) that may disrupt production or distribution or require
substantial resources to correct. In addition, the discovery of conditions that violate these rules, including failure to conform to cGMPs,
could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product,
manufacturer or holder of an approved NDA, including voluntary recall and regulatory sanctions as described below.

20

Once an approval or clearance of a drug is granted, the FDA may withdraw
the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches
the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency,
or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved
labeling to add new safety information; imposition of post-market or clinical trials to assess new safety risks; or imposition of distribution
or other restrictions under a REMS program.

Other potential consequences include, among other
things:

●Restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

●Fines, warning letters or other enforcement-related letters, or clinical holds on post-approval clinical trials;

●Refusal of the FDA to approve pending marketing applications or supplements to approved marketing authorizations, or suspension or
revocation of product approvals;

●