Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 134

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 134
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 employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by its competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that its proprietary position is based, in part, on its know -howand trade secrets, a competitor’s discovery of its trade secrets or other unauthorized use or disclosure would impair its competitive position and may have a material adverse effect on its business. NLS Risks Related to its Intellectual Property NLS has been granted several issued patents and filed multiple patent applications. There can be no assurance that any of its patent applications will result in issued patents. As a result, its ability to protect its proprietary technology in the marketplace may be limited. NLS has been granted issued patents in countries worldwide. These issued patents cover a range of areas including: the therapeutic use of mazindol for the treatment of ADHD and combination therapies containing mazindol (add -onswith iron or stimulants) in sleep disorders such as narcolepsy or IH. NLS has also filed patent applications in many countries worldwide. Unless and until its pending patent applications are issued, their protective scope is impossible to determine. It is impossible to predict whether or how many of its patent applications will result in issued patents. Even if pending applications are issued, they may be issued with coverage significantly narrower than what NLS currently seek. NLS’s proprietary position for its product candidates currently depends upon patents protecting the method of use, which may not prevent a competitor or other third party from using the same product candidate for another use. The primary patent based intellectual property protection for its product candidates are patents granted on the method of use and formulation. NLS does not have patents or patent applications covering its products as a composition of matter (i.e., compound claims) for all its product candidates. Composition of matter patent claims on the active pharmaceutical ingredient, or API, in pharmaceutical drug products are generally considered to be the favored form of intellectual property protection for pharmaceutical products, as such patents provide protection without regard to any particular method of use, manufacture or formulation of the API used. Method of use patent claims protect the use of a product for the specified method and dosing. These types of patent claims do not prevent a competitor or other third party from making and marketing an identical API for an indication that is outside the scope of the method claims or from developing a different dosing regimen. Moreover, even if competitors or other third parties do not