Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 287

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 287
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 obtaining regulatory approval or commercialization for human uses (the “Initial MIRALOGX License Agreement”).
On November 10, 2023, we and MIRALOGX entered into the Amendment No. 1 to the Amended and Restated License Agreement, pursuant to which
the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in
addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and
commercialization of veterinary, in addition to human, therapeutic treatments and uses (together with the “Initial MIRALOGX License
Agreement, the “MIRALOGX License Agreement”). “Licensed Product” is defined in the agreement as a drug product
containing as an active agent 2,4,6-tris(3,4-dihydro-2H-pyrrol-2-yl) pyridine or a pharmaceutically acceptable salt, ester, or solvate
thereof. We also have the right to grant corresponding sublicenses under the licensed patent rights. The MIRALOGX License Agreement provides
for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales of Licensed Products by us or our sublicensees and
on non-royalty bearing milestone revenue. There are no up-front, execution, or milestone payments in the license agreement. Further,
no payments have been made to date under the agreement.

Government
Regulation

The
FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies
involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and
local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness,
labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling
and export and import of our drug candidates.

In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations.
The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes
and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements
at any time during the product development process, approval process or