Company: APXIF
Filing Date: 2025-01-22
Form Type: F-4
Source: 0001213900-25-005463
Chunk: 167

Company: APx Acquisition Corp. I
Filing Date: 2025-01-22
Form: F-4
Chunk 167
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 and validated through our partner laboratories, such as CIBIC in Argentina, where the laboratory assumes responsibility for ensuring compliance with local regulatory and licensing requirements. For example, CIBIC maintains authorizations from the appropriate local authorities, including the Colegio de Bioquímicos and the Colegio de Médicos, and employs licensed professionals authorized to sign off on diagnostic reports, regardless of whether the test was originally developed by CIBIC or another entity. This ensures that the diagnostic tests meet the required standards for use in each country. If there are issues with third parties like CIBIC who provide these services, then we could face significant disruptions in our operations, which could negatively affect us and our financial results. We work closely with its laboratory partners to ensure that any diagnostic test developed for use in Latin American markets adheres to applicable regulations within that jurisdiction. Our goal is to develop and validate diagnostic tests that meet the local regulatory requirements, enabling the use of these tests in clinical settings for patients within each country. Our compliance strategy includes confirming that all tests developed through our partner laboratories align with the regulatory and legal standards necessary to classify them as diagnostic tools within each specific market. If we are unable to comply with applicable regulations in those jurisdictions, we could face regulatory penalties, damage to our reputation, and a potential loss of market access in those countries. 64 Applicable regulatory approval processes or clearances may be expensive, time -consuming, and uncertain, and our failure to obtain or comply with such approvals and clearances could have an adverse effect on our business, financial condition, or operating results. In addition, changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of our products, which may negatively affect our ability to obtain or maintain comparable regulatory approval of our products, if required, or potentially delay or limit our ability to market these products as diagnostic tools in certain regions. Changes in laws and regulations, including healthcare policy changes, may adversely affect our business, financial condition and results of operations. The clinical laboratory testing industry is highly regulated, and failure to comply with applicable regulatory, supervisory, accreditation, registration or licensing requirements may adversely affect our business, financial condition and results of operations. In particular, the laws and regulations governing the marketing and research of clinical diagnostic testing are extremely complex and in many instances there are no clear regulatory or judicial interpretations of these laws and regulations, increasing the risk that we may be found to be in violation of these laws. In March 2010