Company: APXIF
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065703
Chunk: 177

Company: APx Acquisition Corp. I
Filing Date: 2025-07-18
Form: F-4/A
Chunk 177
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 their own, comparable procedures. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not be able to obtain a required regulatory approval. Our products, if used for the diagnosis of disease, could be subject to government regulation, and the regulatory approval and maintenance process for such products may be expensive, time -consuming , and uncertain both in timing and in outcome. Some of our products, including tests developed for use in clinical settings, such as the ones in our Heritas Diagnostics operating segment, are classified as diagnostic products, which may be subject to various regulatory frameworks depending on the country where they are offered. In Latin America, our diagnostic tests are primarily developed 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. 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