Item 1.01 Entry into a Material Definitive Agreement
On March 9, 2020, the Company entered into a distribution agreement with
Co-Diagnostics Inc. pursuant to which Co-Diagnostics granted the Company the
exclusive distribution rights to its qPCR infectious disease kits, Logix Smart
COVID-19 PCR diagnostic test and Co-Dx Box™ instrument for Russia. These
products 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.
The distribution agreement has a term of one year, but can be terminated by
either party at any 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 Russia. The Company does not have any offices or
facilities in Russia and intends to distribute the products through
sub-distributors, who will have the responsibility of obtaining or confirming
any regulatory approval necessary to market the products in Russia.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
99.1 Distribution agreement dated March 9, 2020 between the Company and
Co-Diagnostics Inc.*
___________
* 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 11, 2020 By: /s/ Justin E. Anderson
Justin E. Anderson
Chief Executive Officer
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