Company: APXIF
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026339
Chunk: 168

Company: APx Acquisition Corp. I
Filing Date: 2025-03-31
Form: F-4/A
Chunk 168
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 and validation and additional administrative review periods. Seeking foreign regulatory clearance, authorization or approval could result in difficulties and costs for us and our collaborators and require additional preclinical studies, clinical trials or clinical investigations which could be costly and time -consuming. Regulatory requirements and ethical approval obligations can vary widely from country to country and could delay or prevent the introduction of certain of our products and services in those countries. The foreign regulatory clearance, authorization or approval process involves all of the risks and uncertainties associated with FDA clearance, authorization or approval. If we or our collaborators fail to comply with regulatory requirements in international markets or to obtain and maintain required regulatory clearances, authorizations or approvals in international markets, or if those approvals are delayed, our target market will be reduced and our ability to realize the full market potential of our products and services will be unrealized. Failure to comply with applicable clinical laboratory licensure requirements may result in a range of enforcement actions, including license suspension, limitation, or revocation, directed plan of action, onsite monitoring, civil monetary penalties, criminal sanctions, exclusion from some healthcare systems’ programs, as well as significant adverse publicity. Any sanction imposed could have a material adverse effect on our business, financial condition and results of operations. Even if we were able to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so. The College of American Pathologists, or CAP, maintains a clinical laboratory accreditation program. CAP asserts that its program is “designed to go well beyond regulatory compliance” and helps laboratories achieve the highest standards of excellence to positively impact patient care. While not required to operate a CLIA -certifiedlaboratory, many private insurers require CAP accreditation as a condition to contracting with clinical laboratories to cover their tests. In addition, some countries require CAP accreditation as a condition to permitting clinical laboratories to test samples taken from their citizens. We have CAP accreditations for our laboratories. Failure to maintain CAP accreditation could have a material adverse effect on the sales of our tests, which in turn would negatively affect our business, financial condition, results of operations or growth prospects. We expect to rely on third parties to conduct any future studies of our technologies that may be required by U.S. or foreign regulatory bodies, and those third parties may not perform satisfactorily. We expect to rely on third parties such as contract research organizations, medical institutions and clinical investigators to conduct studies. Our reliance on these third parties for clinical development activities will reduce our control over these activities. We may not be able to secure