Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 44

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 44
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 to orphan drug exclusivity, which means the FDA may not approve any other application
to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical
superiority over the product with orphan exclusivity.

In the EU, orphan medicinal product designation
also entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity is granted
following drug or biological product approval. This period may be reduced to six years if, at the end of the fifth year, it is established
that the orphan designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to
justify maintenance of market exclusivity.

Orphan drug designation must be requested before
submitting an application (NDA/BLA) for marketing approval. Orphan drug designation does not convey any advantage in, or shorten the duration
of, the regulatory review and approval process.

Other Healthcare Laws and Compliance Requirements

Manufacturing, sales, promotion and other activities
following product candidate approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including
the Centers for Medicare & Medicaid Services, other divisions of the Department of Health and Human Services, the U.S. Department
of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration,
the Environmental Protection Agency and state and local governments.

We will also be subject to various federal and
state laws targeting fraud and abuse in the healthcare industry. These laws may impact, among other things, our proposed sales, marketing
and educational programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in
which we conduct our business. The laws that may affect our ability to operate include:

| ● | The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either (1) the referral of an individual to a person for furnishing any item or service for which payment is available under a federal health care program, or (2) the purchase, lease, order or recommendation thereof of any good, facility, service or item for which payment is available under a federal health care program; |

| ● | The False Claims Act and civil monetary penalty laws, which prohibit, among