38
We have
also entered into a research and development services agreement
with UBI. Pursuant to this agreement, UBI and
its affiliates
provide research and development services to us. Service fees payable by
us to UBI for research and development projects undertaken
in accordance with the research and development plan
will be determined by a joint steering
committee and set forth in a research and
development plan. The
aggregate services fees payable
by us under
the research and
development services agreement are
subject to a
quarterly cap throughout the term of the agreement. The research and development services agreement expires in August
2026.
Intellectual Property
Our ability to
obtain and maintain
intellectual property protection
for our product
candidates and core
technologies is fundamental
to
the
long-term
success
of
our
business.
We
rely
on
a
combination
of
intellectual
property
protection
strategies,
including
patents,
trademarks, trade secrets, license agreements, confidentiality policies and procedures, nondisclosure agreements, invention assignment
agreements and technical
measures designed to
protect the intellectual
property and commercially
valuable confidential information
and
data used in our business.
In summary, our patent estate includes issued patents and patent applications which claims cover our
Vaxxine
Platform and each of our
product candidates. As of December 31, 2021, our patent estate included ten U.S. issued patents, twelve U.S. patent applications, three
U.S. provisional patent
applications, four pending
Patent Cooperation Treaty
(“PCT”) patent applications,
98 issued non-U.S.
patents
and 194 pending non-U.S. patent applications.
For our
product candidates
targeting the
prevention and
treatment of
neurodegenerative disease,
including claims
covering UB-311,
UB-312, patent rights are provided by patents and patent applications, the majority of which are being prosecuted in the
United States,
Australia,
Brazil,
Canada,
China,
the
EPO,
Hong
Kong,
Indonesia,
India,
Israel,
Japan,
the
Republic
of
Korea,
Mexico,
Russia,
Singapore,
South
Africa,
Taiwan
and
the
United
Arab
Emirates
directed
to
peptide
vaccines
for
the
prevention
and
treatment
of
neurodegenerative diseases.
These issued
patents and
patent applications,
if issued,
are expected
to expire
between 2022
and 2039,
excluding any patent term adjustments or patent term extensions.
For our product candidates directed to peptide immunogens targeting CGRP and formulations thereof
for the prevention and treatment
of migraine, including
UB-313, patent rights
may be provided
by a patent
family being prosecuted
in the United
States, Australia, Brazil,
Canada, China,
India, Indonesia,
Japan, Mexico, Russia,
the Republic
of Korea, Singapore,
Taiwan and the United
Arab Emirates. These
patent applications, if issued, are expected to expire in 2039, excluding any patent term adjustments or patent term extensions.
For
our
product
candidates
targeting
cholesterol
and
cardiovascular
disease,
including
our
anti-PCSK9
product
candidate
targeting
PCSK9
and
formulations
thereof
for
prevention
and
treatment
of
PCSK9-mediated
disorders,
we
are
in
the
process
of
acquiring
a
pending patent application in Taiwan and a pending PCT patent application. This Taiwanese
patent application, if issued, and any U.S.
or non-U.S. patent issuing from this PCT
patent application, if such patent is issued,
is expected to expire in 2041, excluding
any patent
term adjustment or patent term extension.
For our product
candidates targeting SARS-CoV-2,
including UB-612 for
COVID-19, we have
pending patent applications
in Brazil,
Pakistan and Taiwan,
one pending PCT patent
application and three provisional
patent applications in the
United States. These patent
applications, if issued, and any U.S. or
non-U.S. patent issuing from this PCT or
provisional patent application, are expected to expire
between 2041 and 2042, excluding any patent term adjustments or patent term extensions.
For each product candidate utilizing
the Vaxxine
platform, additional patent rights directed
to artificial T helper
cell epitopes and to a
CpG delivery system are provided by
patents and patent applications, the majority
of which are being prosecuted in
the United States,
Australia, Austria,
Belgium, Brazil,
Canada, Chile,
China, Colombia,
Denmark, the
EPO, France,
Germany,
Hong Kong,
Indonesia,
India, Ireland, Israel, Italy, Japan, Mexico, the Netherlands, New Zealand, Peru, Philippines, the Republic of Korea, Russia, Singapore,
South
Africa,
Spain,
Sweden,
Switzerland/Liechtenstein,
Taiwan,
Thailand,
the
United
Arab
Emirates,
the
United
Kingdom
and
Vietnam. These
issued patents and patent
applications, if issued, are
expected to expire between
2023 and 2039, excluding
any patent
term adjustments or patent term extensions.
The term of
individual patents
depends on the
countries in which
they are obtained.
The patent
term is 20
years from the
earliest effective
filing date of a
non-provisional patent application in most
of the countries in
which we file, including the
United States. In the United
States, a
patent’s
term may
be lengthened
by patent
term adjustment,
which compensates
a patentee
for administrative
delays by
the
USPTO in
examining and granting
a patent, or
may be shortened
if a patent
is terminally disclaimed
over an earlier
filed patent. The
term of a patent that
covers a drug or biological product
may also be eligible for patent
term extension when FDA approval is
granted
for a
portion of
the term
effectively lost
as a
result of
the FDA
regulatory review
period, subject
to certain
limitations and
provided
statutory and regulatory requirements are met.
In addition to our reliance on patent protection for our inventions, products and technologies, we also seek to protect
our brand through
the procurement of trademark rights.
We
own registered trademarks and pending
trademark applications for our brands,
including our
“Vaxxinity”, “United Neuroscience” and “COVAXX” brands and
other related names
and logos, in
the United States
and certain
foreign
jurisdictions.