Item 1.01 Entry into a Material Definitive Agreement
On March 13, 2020, the Company's subsidiary, PreCheck Health Services S.A.S.,
entered into a distribution agreement dated March 13, 2020, with Co-Diagnostics
Inc. pursuant to which Co-Diagnostics granted the Company's subsidiary the
exclusive distribution rights to its qPCR infectious disease kits, Logix Smart
COVID-19 PCR diagnostic test and Co-Dx Box™ instrument for Ecuador. The
distribution agreement has a term of one year, but can be terminated by either
party on 30 days' notice. The agreement provides that it is the Company's
responsibility to obtain all necessary licenses and permits for the marketing of
the product in Ecuador. The Company does not have any offices or facilities in
Ecuador and intends to distribute the products through sub-distributors or other
representative.
On March 13, 2020, the Company entered into a marketing agreement dated March
12, 2020 with Co-Diagnosis and Health Tech Innovation Systems, Inc., which is
the distributor for Co-Diagnostics' products in Panama. Pursuant to the
agreement the Company has the right to purchase Logix Smart COVID-19 PCR
diagnostic test and Co-Dx Box instrument from Co-Diagnostics for sale by the
Company to its customers in Panama. The Company is to pay Health Tech Innovation
Systems a fee in connection with any sales by the Company to its customers in
Panama. The marketing agreement has a term of one year, but can be terminated by
any party on 30 days' notice.
The products covered by both agreements are in vitro diagnostic tests, and
Co-Diagnostics has reported in its SEC filings that it has received ISO 13485
certification relating to the design and manufacture of its medical device
products, and that the ISO certification indicates that it meets the standards
required to self-certify certain of its products and affix a CE marking for
sales of its products in countries accepting the CE marking (not in the United
States) with only minimal further governmental approvals in each country, and
its Zika and tuberculosis tests were CE-marked in 2018, its first multiplex test
(Zika, Dengue, and Chikungunya) was CE-marked in 2019, and it received a CE mark
for its Logix Smart Covid-19 test for corona virus in February 2020.
Item 7.01 Regulation FD Disclosure
On March 13, 2020, the Company issued a press release covering the Ecuador
distribution agreement and a purchase order placed by the Company.
In accordance with General Instruction B.2 of Form 8-K, the information in Item
7.01 of this Current Report on Form 8-K, including Exhibit 99.3, shall not be
deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended, or otherwise subject to the liabilities of that section,
and shall not be deemed to be incorporated by reference into any of the
Company's filings under the Securities Act of 1933, as amended, or the
Securities Exchange Act of 1934, as amended, whether made before or after the
date hereof and regardless of any general incorporation language in such
filings, except to the extent expressly set forth by specific reference in such
a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
99.1 Distribution agreement dated March 13, 2020 between co-Diagnostics
Inc. and the Company*
99.2 Marketing agreement dated March 12, 2020 among Co-Diagnostics Inc.,
Health Tech Innovation Systems, Inc. and the Company*
99.3 Press release dated March 13, 2020
________
* Confidential information in this agreement has been omitted.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this Report to be signed on its behalf by the
undersigned hereunto duly authorized.
PreCheck Health Services, Inc.
Date: March 13, 2020 By: /s/ Justin E. Anderson
Justin E. Anderson
Chief Executive Officer
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