Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 69

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 69
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licensing technologies and products complementary to our programs
or advantageous to our business.

46

The
key competitive factors affecting the success of each of our product candidates, if approved, are likely to be its efficacy, safety,
tolerability, frequency and route of administration, convenience and price, the level of branded and generic competition, market acceptance
by physicians and patients, and the availability of coverage and reimbursement from government and other third-party payors.

Any
product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.

The
Patient Protection and Affordable Care Act, signed into law on March 23, 2010, includes a subtitle called the Biologics Price Competition
and Innovation Act of 2009, or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or
interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be
submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval
of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed.
During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves
a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical
trials to demonstrate the safety, purity and potency of its product.

We
believe that any of our future product candidates approved as a biological product under a BLA should qualify for the 12-year period
of exclusivity. However, there is a risk that this exclusivity could be shortened due to Congressional action or otherwise, or that the
FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for
generic competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, could be substituted for any
one of our reference products in a way that is similar to traditional generic substitution for non-biological products will depend on
a number of marketplace and regulatory factors that are still developing.

Our
future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We
are highly dependent on our current senior management. If we fail to retain current members of our senior management and scientific personnel,