Company: APXIF
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026339
Chunk: 115

Company: APx Acquisition Corp. I
Filing Date: 2025-03-31
Form: F-4/A
Chunk 115
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 cannot assure you that replacement sequencers and associated reagents will be available or will meet our quality control and performance requirements for our and our partners’ laboratory operations. If we encounter delays or difficulties in securing, reconfiguring or revalidating the equipment and reagents we require for our tests, our business, financial condition, results of operations and reputation could be adversely affected. Our research and development efforts will be hindered if we are not able to obtain samples, enter into contracts with third parties for access to samples, or complete timely enrollment in future clinical studies, or if defects are discovered in our products. Access to human sample types, such as blood, tissue, saliva and stool is necessary for our research and product development. One of our current sources of human samples for research and product development is through clinical validation protocols, where samples are collected specifically for research purposes under appropriate ethical approvals. These protocols are reviewed and approved by an Ethics Committee in Argentina, in accordance with country -specificlaws and regulations. Additionally, during routine clinical testing, patients have the option to provide informed consent 34 at the time of sample collection. This consent permits the use of their anonymized genomic data for future research purposes, ensuring compliance with privacy and ethical standards. For our consumer wellness and preventive health solutions, customers consent to terms and conditions at the time of purchase that specify anonymized data may be used for research purposes. This approach allows us to leverage data responsibly for research while maintaining user privacy. Acquiring samples from individuals with certain profiles, clinical diagnoses or associated clinical outcomes may require additional partnerships, purchases, or specific clinical studies. Lack of available samples can delay development timelines and increase costs of development. Generally, the agreements under which we gain access to human samples are non -exclusive. Other companies may compete with us for access. Additionally, the process of negotiating access to samples can be lengthy and it may involve numerous parties and approval levels to resolve complex issues such as usage rights, institutional review board approval, privacy rights, publication rights, intellectual property ownership, and research parameters. If we are not able to negotiate access to clinical samples with research institutions, hospitals, clinical partners, pharmaceutical companies, or companies developing therapeutics on a timely basis, or at all, or if other laboratories or our competitors secure access to these samples before us, our ability to research, develop and commercialize future products will be limited or delayed. We aimed for high standards in clinical research, which involves following current ethical recommendations and conducting clinical studies under Good Clinical Practices (“GCP”). Any failure in these