Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 29

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 29
---
 discounting program (beginning in 2025). The IRA permits the Secretary of the Department of Health and Human
Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years. On August 29,
2023, HHS announced the list of the first ten drugs that will be subject to price negotiations, although the drug price negotiation programs
is currently subject to legal challenges. For that and other reasons, it is currently unclear how the IRA will be effectuated.

Moreover,
there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products,
which has resulted in several Congressional inquiries, proposed and enacted legislation and executive orders issued by the President
designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for drug products. Individual states in the United States
have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price
or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency
measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Data
Privacy and Security Laws

Numerous
state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related
and other personal information, and could apply now or in the future to our operations or the operations of our partners. In the United
States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security
laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other
personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance
efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions
on data processing.

Competition

The
pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, government regulation
and a strong emphasis on proprietary products. While we believe that our technology, knowledge and scientific resources provide us with
certain competitive advantages, we face competition from many sources, including foreign and domestic pharmaceutical and biotechnology
companies, academic institutions, governmental agencies and public and