Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 395

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 395
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 and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, 192

formulation data and know -howfor all products containing mazindol as an active substance, and all post -marketingclinical studies and periodic safety reports from 1973 onwards. Under the Agreement, NLS has obtained the same rights on a non -exclusivebasis in all territories outside of the U.S, except for Japan, with the right to cross -referencethe Sanorex NDA with non -U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations. As consideration for the license, NLS agreed to pay Novartis $250,000 upon the signing of the agreement with milestone payments due as follows: (i) $750,000 payable following the end of a Phase II meeting with the FDA and subject to the FDA’s review and feedback on the 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