Item 1.01 Entry into a Material Definitive Agreement
On April 1, 2020, Biomerica, Inc. ("Biomerica") entered into two separate
non-exclusive license agreements (the "License Agreements") with the Mount Sinai
Icahn School of Medicine in New York ("Mount Sinai") to license technology from
Mount Sinai that Biomerica intends to use to scale up and manufacture a
laboratory version serological test for SARS-CoV-2 coronavirus. This test uses
the ELISA microplate format that can run on existing open system equipment found
in most hospitals and clinical laboratories in the United States. The
non-exclusive License Agreements provide for royalty payments to Mount Sinai
based on a percentage of gross sales of commercial products manufactured and
sold by Biomerica that incorporate the Mount Sinai technology licensed under the
License Agreements.
While Biomerica believes it will be able to utilize the licensed technology to
make and sell a commercial product, there can be no assurance Biomerica will be
successful at transferring the technology, further developing the technology as
needed for commercialization, incorporating the technology into its products,
utilizing the technology for Biomerica's intended purposes, or manufacturing a
final product that meets market demands or regulatory requirements. Biomerica
intends to apply for expedited clearance with the FDA under the new Emergency
Use Authorization process for this new test format.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor"
for forward-looking statements. Certain information included in this Current
Report on Form 8-K contains statements that are forward-looking, such as
statements relating to Biomerica's expectations of the use of the technology
licensed from Mount Sinai, Biomerica's commercialization and scaling of its
SARS-CoV-2 serological tests, and payments to be made to Mount Sinai related to
the License Agreements. Such forward-looking information involves important
risks and uncertainties that could significantly affect anticipated results in
the future, including, without limitation: Biomerica's ability to transfer,
further develop, integrate and use the licensed technology; Biomerica's ability
to manufacture and scale its commercial products using the licensed technology;
results of studies testing the efficacy of Biomerica's commercial products;
regulatory approvals necessary prior to commercialization of Biomerica's
products; availability of Biomerica's products; capacity, resource and other
constraints on Biomerica's suppliers; dependence on third party supply chain and
manufacturers; dependence on international shipping carriers; governmental
import/export regulations; demand for Biomerica's commercial products;
competition from other similar products and from competitors that have
significantly more financial and other resources available to them; governmental
virus control regulations; and Biomerica's ability to obtain patent protection
and other intellectual property protections on any aspects of its test
technologies or commercial products; and Biomerica's ability to develop and
manufacture certain tests it has not yet finalized and has never previously
manufactured. Accordingly, such results may differ materially from those
expressed in any forward-looking statements made by or on behalf of Biomerica.
Additionally, potential risks and uncertainties include, among others,
fluctuations in Biomerica's operating results due to its business model and
expansion plans, downturns in international and or national economies,
Biomerica's ability to raise additional capital, the competitive environment in
which Biomerica will be competing, and Biomerica's dependence on strategic
relationships. Additional risks and uncertainties associated with market
conditions and Biomerica are discussed in Biomerica's filings with the
Securities and Exchange Commission, including the "Risk Factors" section of
Biomerica's Annual Report on Form 10-K for the year ended May 31, 2019.
Biomerica is under no obligation to update any forward-looking statements after
the date of this Form 8-K.
Item 7.01 Regulation FD Disclosure
On April 2, 2020, Biomerica issued a press release announcing the execution of
the two License Agreements. A copy of Biomerica's press release is furnished
hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated in
this Item 7.01 in its entirety. Both of the License Agreements are non-exclusive
and Mount Sinai is making this technology available to other licensees.
The information contained in, or incorporated into, this Item 7.01 is being
furnished and shall not be deemed "filed" for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by reference
into any registration statement or other filing under the Securities Act of
1933, as amended, except as shall be expressly set forth by specific reference
to such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
Number Description
99.1 Press Release issued April 2, 2020.
2
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