Seelos may be subject to claims challenging the inventorship of its licensed patents, any future patents Seelos may own and other intellectual
Although Seelos is not currently experiencing any claims challenging the inventorship of its licensed patents or Seelos' licensed or owned intellectual property,
Seelos may in the future be subject to claims that former employees, collaborators or other third parties have an interest in Seelos' licensed patents or other licensed or owned intellectual
property as an inventor or co-inventor. For example, Seelos may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing Seelos'
product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. If Seelos fails in defending any such claims, in addition to paying monetary
damages, Seelos may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse
effect on Seelos' business, financial condition and results of operations. Even if Seelos is successful in defending against such claims, litigation could result in substantial costs and be a
distraction to management and other employees.
If Seelos does not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation extending the terms of Seelos'
licensed patents and any future patents Seelos may own, Seelos' business, financial condition and results of operations may be materially and adversely affected.
Depending upon the timing, duration and specifics of FDA regulatory approval for Seelos' product candidates, one or more of its licensed U.S. patents or future
U.S. patents that Seelos may license or own may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the
Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during drug development and the FDA
regulatory review process. This period is generally one-half the time between the effective date of an investigational new drug application ("IND") (falling after issuance of the
patent), and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application. Patent term restorations, however, cannot extend the
remaining term of a patent beyond a total of 14 years from the date of product approval by the FDA.
The application for patent term extension is subject to approval by the USPTO, in conjunction with the FDA. It takes at least six months to obtain approval of the
application for patent term extension. Seelos may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant
patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than Seelos requests. If Seelos is
unable to obtain patent term extension or restoration or the term of any such extension is less than Seelos requests, the period during which Seelos will have the right to exclusively market its
product will be shortened and Seelos' competitors may obtain earlier approval of competing products, and Seelos' ability to generate revenues could be materially adversely affected.
The market price of Seelos' common stock is expected to be volatile.
The trading price of Seelos' common stock is likely to be volatile. Seelos' stock price could be subject to wide fluctuations in response to a variety of factors,
including the following:
- results from, and any delays in, planned clinical trials for Seelos' product candidates, or any other future product candidates, and the results of trials of competitors
or those of other companies in Seelos' market sector;
- any delay in filing an NDA for any of Seelos' product candidates and any adverse development or perceived adverse development with respect to the FDA's review
of that NDA;
- significant lawsuits, including patent or stockholder litigation;
- inability to obtain additional funding;
- failure to successfully develop and commercialize Seelos' nization's product candidates;
- changes in laws or regulations applicable to Seelos' product candidates;
- inability to obtain adequate product supply for Seelos' product candidates, or the inability to do so at acceptable prices;
- unanticipated serious safety concerns related to any of Seelos' product candidates;
- adverse regulatory decisions;
- introduction of new products or technologies by Seelos' competitors;
- failure to meet or exceed drug development or financial projections Seelos provides to the public;
- failure to meet or exceed the estimates and projections of the investment community;