Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 48

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 48
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    GDC coil system
     
    Stryker
     
    Detachable Coil system
     
    Embolization of intracranial aneurysms
  
    Axium prime coil system
     
    Medtronic
     
    Detachable Coil system
     
    Embolization of intracranial aneurysms

Manufacturing

We do not have any manufacturing facilities or personnel at this time,
except that Darnatein maintains and uses manufacturing facilities owned by Joint Center for Biosciences, Darnatein’s affiliate and
the Company’s shareholder, for purposes of R&D and clinical and preclinical materials for its sole use. We currently rely on
CMOs for the manufacture of our product candidates for preclinical and clinical testing in non-commercial quantities.

Our product candidates include small molecules, vaccines, and monoclonal
and bispecific antibodies. Several contract manufacturing facilities exist that have expertise in each product type and we anticipate
that our product candidates can be produced by them at scale and in a cost-effective manner. As needed, we also expect to rely on
CMOs for the manufacturing of companion diagnostics, which are assays or tests to identify an appropriate patient population. Depending
on the technology solutions we choose, we may rely on multiple third parties to manufacture and sell a single test.

Vaximm has a master service agreement with Richter-Helm BioLogics
GmbH & Co. KG (“RHB”), a CMO located in Germany, for the manufacture of Vaximm’s product candidates. RHB will
provide cell line development, process development, manufacturing, and related services for Vaximm’s product candidates. The agreement
became effective April 10, 2012, and will remain in effect until terminated by either party. Vaximm pays RHB for services rendered
based on agreed-upon rates specified in individual work orders. Vaximm retains ownership of all intellectual property related to
its product candidates, while RHB owns IP related to manufacturing processes developed under the agreement.

27

Commercialization

We will objectively assess and choose each program’s commercialization
option that maximizes potential value for patients and for our stockholders. We anticipate optimizing commercial value through various
options, including internal advancement, strategic partnerships, and spin-outs or public offerings. If we opt to commercialize a
particular candidate ourselves, we anticipate assembling a commercialization team inclusive of sales and marketing operations to promote