Company: ARAI
Filing Date: 2025-05-13
Form Type: S-1/A
Source: 0001641172-25-009841
Chunk: 93

Company: Arrive AI Inc.
Filing Date: 2025-05-13
Form: S-1/A
Chunk 93
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 Federal Aviation Administration’s (“FAA”) Beyond Visual Line of Sight (“BVLOS”) requirements. These regulations require operators to demonstrate that their drones can fly beyond the visual line of sight of the pilot or observer and still maintain safe operation. Meeting these requirements has been a significant challenge for many companies seeking to use drones for delivery and has slowed down the pace of adoption. Despite these challenges, many companies are investing heavily in developing and testing delivery drones and robots that can meet the FAA’s BVLOS requirements. As such, Arrive can expect continued progress in the adoption of drones and autonomous robots for delivery, albeit with careful consideration of legal and ethical implications, including compliance with BVLOS requirements.

Also, in our early market focus involving placing our products and providing services to medical facilities, we must also comply with the HIPAA if we handle PHI in the course of our commercial business operations. Please see “ Risk Factors—Risks Related to our Business and Future Commercial Operations – Regulations and Compliance—We will be subject to rapidly changing and increasingly stringent laws, regulations, industry standards, and other obligations relating to privacy, data protection, and data security. The restrictions and costs imposed by these requirements, or our actual or perceived failure to comply with them, could harm our business and commercial operations” for detailed discussion. Despite the need to comply with HIPAA, we are only a provider of intelligent mailboxes and do not and will not manufacture, sell or transport medical or biological products or prescriptions, we are not and will not be subject to any regulations in those areas, for example, the Federal Food, Drug, and Cosmetic Act of 1938 and the Medical Device Amendments of 1976.

Regulations Related to the Transportation of Pharmaceutical and Biomedical Products

Even though we do not and will not manufacture,
sell or transport medical or biological products or prescriptions, there are several regulations related to the transportation of pharmaceutical
and biomedical products and our potential third party service providers may be subject to such regulations, described further below.

Title 21 of the Code of Federal Regulations (CFR)
regulates the shipping, warehousing, distribution, and record keeping of pharmaceuticals. Because of the sensitive nature of some pharmaceutical
products, there are many federal, state, and local laws that dictate how to package and transport the items. There are also several different
federal agencies with oversight, including the Food and Drug Administration (FDA), the FDA’s role is to protect the public’s health
by ensuring that the items to be consumed are safe. Prescription drugs and medical devices