Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 130

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 130
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 Furthermore, there is a risk of a sole approved manufacturer significantly raising prices. If prices for mazindol or other raw materials were to be significantly increased, its profit margins and sales, if any, would be greatly reduced and, assuming its products were approved for commercialization or marketing, delay product launches, or delay clinical trials at earlier stages of development. Such price increase occurrences could be resolved by the successful FDA approval of an alternate supplier; however, such approval process can be lengthy and costly. There can be no guarantee that a resolution would be reached in the event of a significant price increase by its supplier of mazindol. NLS relies on third parties to conduct its pre-clinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, NLS may not be able to obtain regulatory approval for or commercialize its product candidates and its business could be substantially harmed. NLS has relied upon and plan to continue to rely upon third -partyCROs to monitor and manage data for its ongoing pre -clinicaland clinical programs. NLS relies on these parties for execution of its pre -clinicaland clinical studies, and controls only certain aspects of their activities. Nevertheless, NLS is responsible for ensuring that each of its studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and its reliance on the CROs does not relieve it of its regulatory responsibilities. NLS and its CROs and other vendors are required to comply with current cGMP, Good Clinical Practices, or GCP, quality system requirements, or QSR, and Good Laboratory Practices, or GLP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area, and comparable foreign regulatory authorities for all of its product candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors, principal investigators, study sites and other contractors. If NLS or any of its CROs or vendors fail to comply with applicable regulations, the clinical data generated in its clinical studies may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require it to perform additional clinical studies before approving its marketing applications. NLS cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of its clinical studies comply with GCP regulations. In addition, its clinical studies must be conducted with product candidates which are produced under cG