Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 26

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 26
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 recording device” to eavesdrop upon a “confidential
communication” without consent of all parties to the communication. Other countries also have, or are developing, laws governing
the collection, use and transmission of personal information, such as the General Data Protection Regulation (“GDPR”) in
the European Union (the “EU”) that became effective in May 2018 and the Personal Information Protection and Electronic Documents
Act that became effective in Canada in April 2000. Further, several states have enacted more protective and comprehensive pharmacy-related
privacy legislation that not only applies to patient records but also prohibits the transfer or use for commercial purposes of pharmacy
data that identifies prescribers. These regulations impose substantial requirements on covered entities and their business associates
regarding the storage, utilization and transmission of and access to personal health and non-health information. Many of these laws apply
to our business.

International Regulation

If we pursue commercialization
of our branded products and proprietary formulations in countries other than the U.S., then we may need to obtain the approvals required
by the regulatory authorities of such foreign countries that are comparable to the FDA and state boards of pharmacy, and we would be
subject to a variety of other foreign statutes and regulations comparable to those relating to our U.S. operations. Regulatory frameworks
and requirements vary by country and could involve significant additional licensing requirements and product testing and review periods.
We currently partner with companies to sell, market and distribute some of our products in certain foreign countries.

 17 

Environmental and Other Matters

We are or may become subject
to environmental laws and regulations governing, among other things, any use and disposal by us of hazardous or potentially hazardous
substances in connection with our research and preparation of our formulations. In addition, we are subject to work safety and labor
laws that govern certain of our operations and our employee relations. In each of these areas, as described above, the FDA and other
government agencies have broad regulatory and enforcement powers, including, among other things, the ability to levy fines and civil
penalties, suspend or delay issuance of approvals, licenses or permits, seize or recall products, and withdraw approvals, any one or
more of which could have a material adverse effect on our business.

Research and Development Expenses

Our research and development
(“R&D”) expenses incurred in 2023 and 2022 primarily included expenses related to development of intellectual property,
researcher and investigator-initiated evaluations, and formulation development related primarily to our ophthalmic products, formulations