Company: APXIF
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026339
Chunk: 167

Company: APx Acquisition Corp. I
Filing Date: 2025-03-31
Form: F-4/A
Chunk 167
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 increased operational costs or delay the establishment and operation of the hub. Such developments may adversely affect our business operations and financial performance. In countries outside the U.S., existing regulations or those that are under consideration may limit or prevent the sale of direct -to -consumergenetic tests. Regulatory conditions in Latin America could potentially influence our product and service offerings. In some countries, like Australia, regulatory bodies require premarket reviews similar to those mandated by the FDA in the United States. Additionally, countries such as Australia, Germany, France, and 63 Switzerland, for example, require a physician’s prescription for genetic tests that provide health information, limiting our offerings in these markets to ancestry -onlytests. Other regions may mandate genetic counseling prior to testing. If similar regulations are enacted in Latin America, they could constrain the market for our products and services or escalate the costs related to their marketing and distribution, affecting availability in certain areas. If we fail to comply with any of these regulations, we could become subject to enforcement actions or the imposition of significant monetary fines, other penalties, or claims, which could harm our operating results, our ability to conduct our business and our growth prospects. If we fail to comply with certain laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business. We are required to maintain certain laboratory licenses and approvals to conduct testing. We may also be subject to regulation in foreign jurisdictions as we seek to expand international utilization of our tests or such jurisdictions adopt new licensure requirements, which may require review of our tests in order to offer them or may have other limitations such as restrictions on the transport of samples necessary for us to perform our tests that may limit our ability to make our tests available internationally. Complying with licensure requirements in new jurisdictions may be expensive, time -consuming, and subject us to significant and unanticipated delays. In order to eventually market certain of our current or future products and services in any particular foreign jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a jurisdiction -by -jurisdictionbasis regarding quality, safety, performance and efficacy. In addition, clinical trials or clinical investigations conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory clearance, authorization or approval in one country does not guarantee regulatory clearance, authorization or approval in any other country. For example, the performance characteristics of certain of our products and services may need to be validated separately in specific ethnic and genetic populations. Approval processes vary among countries and can involve additional product testing