Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 397

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 397
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 preclinical data from Novartis, with the amount to be reduced to $375,000 in case certain toxicology studies must be repeated; (ii) $2 million following the earlier of FDA marketing authorization of Quilience or Nolazol; (iii) 1% of any upfront and milestone payments, if any, from any sublicensees and (iv) $3 million as a one -timepayment upon NLS’s product candidate reaching $250 million in cumulative sales. Intellectual Property NLS has developed a robust patent portfolio of over 100 patents in over 14 countries including the United States, Canada, Australia, China and Japan, and other European and Latin American countries. NLS’s patent portfolio for Quilience and Nolazol currently includes issued patents in the United States and Europe covering the use of mazindol for treatment of ADHD and patent applications filed in major countries to protect NLS’s proprietary controlled release formulation (Notice of Allowance recently received for Europe and Canada) for treatment of ADHD and narcolepsy. Mazindol ER has been grated a formulation patent in the United States, European Union and other countries, providing protection through March 2037. One of NLS’s patents in the United States covering the use of mazindol for the treatment of ADHD received patent term adjustment, thereby extending the patent term of such patent to August 2028. Additionally, NLS received patent approval in Hong Kong covering the use of mazindol for the treatment of ADHD. This patent is expected to expire no earlier than 2037. NLS has successfully launched NPP and secured additional patent grants, that coupled with successfully entering into other expedited development programs, could allow Quilience to reach the market and patients sooner. This further supports NLS’s global strategy with key patents granted the following major markets: Hong Kong, Japan, South Korea, the U.S., Europe and Canada. Such patents pertain to technology, mechanism of action and application for: (i) sleep disorders, including narcolepsy, idiopathic hypersomnia and Kleine -Levinsyndrome, (ii) ADHD, (iii) neurodegenerative diseases including Lewy body disease, Parkinson’s and Alzheimer’s, and (iv) treatment of CNS indications associated with sleep disorders. The following table provides a description of NLS’s key patents and patent applications and is not intended to represent an assessment of claims, limitations or scope of those patents listed. In some cases, a jurisdiction is listed