Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 148

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 148
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 event or penalty described above may inhibit its ability to commercialize its product candidates and adversely affect its business, financial condition, results of operations and prospects. The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses. If any of its product candidates are approved and NLS is found to have improperly promoted off -labeluses of those products, NLS may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, if approved. In particular, while the FDA 37 permits the dissemination of truthful and non -misleadinginformation about an approved product, a manufacturer may not promote a product for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If NLS is found to have promoted such off -labeluses, NLS may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off -labeluse and has enjoined several companies from engaging in off -labelpromotion. The FDA has also requested that companies enter into consent decrees, corporate integrity agreements or permanent injunctions under which specified promotional conduct must be changed or curtailed. If NLS cannot successfully manage the promotion of its product candidates, if approved, NLS could become subject to significant liability, which would materially adversely affect its business and financial condition. Obtaining and maintaining regulatory approval of its product candidates in one jurisdiction does not mean that NLS will be successful in obtaining regulatory approval of its product candidates in other jurisdictions. Its failure to obtain regulatory approval in foreign jurisdictions would prevent its product candidates from being marketed abroad, and any approval NLS is granted for its product candidates in the United States would not assure approval of product candidates in foreign jurisdictions. In order to market any products outside of the United States, NLS must establish and comply with numerous and varying regulatory requirements of other countries regarding clinical trial design, safety and efficacy. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drugs is subject to extensive regulation by the FDA in the United States and other regulatory authorities in other countries. These regulations differ from country to country. Even if NLS obtains and maintains regulatory approval of its product candidates in one jurisdiction, such approval does not guarantee that NLS will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others