Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 16

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 16
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 if applicable, an additional discount. The additional discount applies if non-FAMP increases more than
inflation (measured by reference to the Consumer Price Index - Urban). We also participate in the Tricare Retail Pharmacy Program, under
which we pay quarterly rebates to DoD for prescriptions of our innovator drugs dispensed to Tricare beneficiaries through Tricare Retail
network pharmacies. The governing statute provides for civil monetary penalties for failure to provide information timely or for knowingly
submitting false information to the government.

 12 

Medicare
Part D provides coverage to enrolled Medicare patients for self-administered drugs (i.e., drugs that are not administered by a physician).
Medicare Part D is administered by private prescription drug plans approved by the U.S. government and, subject to detailed program rules
and government oversight, each drug plan establishes its own Medicare Part D formulary for prescription drug coverage and pricing, which
the drug plan may modify from time to time. The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may
condition formulary placement on the availability of manufacturer discounts. In addition, manufacturers, including us, are required to
provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are
in the coverage gap phase of the Part D benefit design. The IRA includes a sunset provision with respect to the coverage gap discount
program starting in 2025 and replaces it with a new manufacturer discount program. In addition, as of October 2022, the IRA established
a Medicare Part D inflation rebate scheme under which, manufacturers will generally owe additional rebates if the average manufacturer
price of a Part D drug increases faster than the pace of inflation. Failure to timely pay a Part D inflation rebate is subject to a civil
monetary penalty.

Private
payor healthcare and insurance providers, health maintenance organizations, and pharmacy benefit managers in the U.S. are adopting more
aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a
condition to including products on formulary with favorable coverage and copayment/coinsurance. These payors may not cover or adequately
reimburse for use of our products or may do so at levels that disadvantage them relative to competitive products.

Intellectual Property 

Our success and ability to compete
depends upon our ability to protect our intellectual property. We conduct a fulsome analysis of the intellectual property landscape prior
to acquiring rights to formulations and filing patent applications. In addition, as of March