Company: SUPN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0001356576-25-000017
Chunk: 447

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 447
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 legal fees;

•Court rulings prohibiting us from selling our products or product candidates, unless the third party licenses its rights to us, which it is not required to do;

•If a license is available from a third party, we may have to pay substantial royalties, fees or grant cross-licenses to our intellectual property rights; and

•Incurring the costs and expending the time necessary to defend against such litigation; and 

•Redesigning our products or product candidates so they do not infringe. This may not be possible or may require substantial monetary expenditures and time.

We face potential litigation and product liability exposures. If successful claims are brought against us, we may incur substantial liabilities.

In recent years, the volume and variety of claims and the amount of damages claimed in litigation against the pharmaceutical industry have increased. For example, in recent years we or our subsidiaries have been involved in litigations alleging violation of federal and state false claims acts and antitrust laws. For more information, refer to Part I, Item 3 - Legal Proceedings contained in this Annual Report Form 10-K. While we strive to conduct our business in accordance with applicable laws, we nevertheless remain exposed to litigation risk. We could be sued by many different parties, including, for example, consumers, healthcare providers, or others selling or otherwise coming into contact with our products and product candidates. Lawsuits or investigations that we may become involved in could be very expensive. These claims may be highly damaging to our reputation, even if the underlying claims are without merit, thereby adversely affecting our business.

The use of our product candidates in clinical trials and the commercial sale of any of our products expose us to the risk of product liability claims. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities. In addition, product liability claims may result in:

•Decreased demand for a commercial product; 

•Impairment of our business reputation and exposure to adverse publicity;

•Withdrawal of bioequivalence and/or clinical trial participants;

•Initiation of investigations by regulators;

•Costs related to litigation;

•Distraction of management's attention from our primary business;

•Substantial monetary awards to patients or other claimants;

•Loss of revenues; and

•Our inability to commercialize products for which we are obtaining marketing approval.

Our product liability insurance coverage for our clinical trials is limited to $30 million per claim and $30 million in the aggregate. Insurance covers bodily injury and property damage arising from our clinical trials, subject to industry-standard