CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported):

 

 

 

(Address of Principal Executive Offices)

 

(Registrant’s Telephone number)

 

Copies to:

Asher S. Levitsky PC

Ellenoff Grossman & Schole LLP

1345 Avenue of the Americas, Suite 1100

New York, New York 10105

Phone: (646) 895-7152

Fax: (646) 895-7238

E-mail: alevitsky@egsllp.com

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b))

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by a check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

 

Securities registered pursuant to Section 12(b) of the Act: None

 

 

 

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.

 

 

 

 ___________

* Confidential information in this agreement has been omitted.

 

 

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.