Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 3

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 3
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of the term effectively lost as a result of the USPTO delay or the FDA regulatory review period (a patent term adjustment or patent term
extension, respectively). The restoration period for FDA delay cannot be longer than five years and the total patent term, including
the restoration period, must not exceed 14 years following FDA approval. The duration of patents outside of the United States
varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest nonprovisional filing
date. However, the actual protection afforded by a patent varies on a product-by-product basis, from country-to-country, and depends
upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the
availability of legal remedies in a particular country, and the validity and enforceability of the patent.

When appropriate, we seek to protect aspects of our technology and
business not amenable to, or that we do not consider appropriate for, patent protection as trade secrets. We seek to protect this intellectual
property, in part, as trade secrets, by entering into confidentiality agreements with those who have access to our confidential information,
including our employees, contractors, consultants, collaborators, and advisors.

3

Vaximm

Vaximm Corporate Overview

Vaximm is developing innovative oral immunotherapies for the treatment
of cancer and immunological disorders. Based on over 20 years of research, Vaximm’s customizable immunotherapy platform has
the potential to be efficiently and effectively adapted to treat various diseases and address specific patient needs. Vaximm currently
has three clinical and pre-clinical drug candidates targeting diseases ranging from glioblastoma to gastrointestinal stromal tumor
to ocular diseases.

Vaximm’s flagship asset, VXM01, is a late clinical-stage (NCT037500701)
immuno-oncology candidate for glioblastoma, which early-stage clinical trials suggest may be a potentially specific and effective
treatment. VXM01 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency
(EMA) for both glioblastoma and pancreatic cancer on August 31, 2017 from FDA and August 23, 2017 from EMA. An Orphan Drug
Designation will permit Vaximm to receive additional years of market exclusivity upon regulatory approval,