Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 39

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 39
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 may result in restrictions on the product’s marketing or even complete withdrawal
of the product from the market. Further, the failure to maintain compliance with regulatory requirements may result in administrative
or judicial actions, such as fines, untitled or warning letters, holds on clinical trials, product seizures, product detention or refusal
to permit the import or export of products, refusal to approve pending applications or supplements, restrictions on marketing or manufacturing,
injunctions, or consent decrees, or civil or criminal penalties, or may lead to voluntary product recalls.

Patent Term Restoration and Marketing Exclusivity

Because drug approval can take
an extended period of time, there may be limited remaining life for the patents covering the approved drug, meaning that the company has
limited time to use the patents to protect the sponsor’s exclusive rights to make, use and sell that drug. In such a case, U.S. patents
may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984,
commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation
for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend
the remaining term of a patent beyond a total of 14 years from the product’s approval date.

In addition, the FDCA provides
a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA
for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same
active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may
not accept for review an abbreviated new drug application (“ANDA”) or a 505(b)(2) Application submitted by another company
for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.

In the future, if appropriate,
we intend to apply for restorations of patent term and/or marketing exclusivity for some of our products; however, there can be no assurance
that any such extension or exclusivity will be granted to us.

Disclosure of Clinical Trial Information

Sponsors of clinical trials
of the FDA-regulated products, including drugs are required to register and disclose certain clinical trial information, which is publicly