UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 22, 2021

graphic

CHEMBIO DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)

Nevada
0-30379
88-0425691
(State or Other Jurisdiction of Incorporation or Organization)
(Commission File Number)
(I.R.S. Employer Identification No.)

555 Wireless Blvd. Hauppauge, NY 11788
(Address of principal executive offices) (Zip code)

Registrant’s telephone number, including area code:  (631) 924-1135

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:


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

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

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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
 
Trading Symbol
 
Name of each exchange on which registered
Common Stock, $0.01 par value
  CEMI
  The NASDAQ Stock Market LLC

Indicate by 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.

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐



Item 8.01
Other Matters.
 
On November 22, 2021, we issued a press release titled “Chembio Diagnostic Systems Prevails in International Arbitration Against BioSure (UK) Ltd.” A copy of the press release is included as Exhibit 99.1 to this report.

Item 9.01
Financial Statements and Exhibits.
 
(d)
Exhibits.
 
 
Exhibit No.
 
Description
   
Press release of Chembio Diagnostics, Inc., dated November 22, 2021
 
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be filed on its behalf by the undersigned hereunto duly authorized.

 
Chembio Diagnostics, Inc.
   
Dated:  November 22, 2021
By:
/s/ Richard L. Eberly
   
Chief Executive Officer and President




Exhibit 99.1

Chembio Diagnostic Systems Prevails in International Arbitration Against BioSure (UK) Ltd

HAUPPAUGE, N.Y., Nov. 22, 2021 (GLOBE NEWSWIRE) — Chembio Diagnostic Systems Inc. (“Chembio”), a subsidiary of Chembio Diagnostics, Inc. (Nasdaq: CEMI), received an international arbitration award Thursday, November 18, 2021 against BioSure (UK) Ltd, Chembio’s former UK distributor of HIV self-tests.

In April 2014, Chembio and BioSure entered into a distribution agreement under which BioSure was licensed the right to sell bundled products in the UK containing Chembio’s SURE CHECK HIV ½ pouched tests.  The distribution agreement terminated on April 1, 2019.  On September 16, 2019, Chembio initiated arbitration in New York, USA alleging BioSure breached the distribution agreement, misappropriated Chembio’s trade secrets, and engaged in other unlawful conduct.  A final merits hearing was held in April 2021.

In the award, the arbitration tribunal held that BioSure breached various provisions of the distribution agreement, breached its implied covenant of good faith and fair dealing, and misappropriated Chembio’s trade secrets under both federal and New York law.  The tribunal concluded that BioSure’s HIV self-test “is substantially based upon and incorporates Chembio Confidential Information in material breach” of the distribution agreement.  According to the tribunal, BioSure breached its duty of good faith and fair dealing by using SURE CHECK HIV ½ pouched tests and Chembio confidential information to develop a competing HIV test, and by misappropriating goodwill that should have inured to Chembio’s benefit.

The tribunal awarded Chembio damages of $1,013,875.70 and costs and attorneys’ fees of $1,654,161.08.  In total, exclusive of interest, Chembio was awarded $2,668,036.78.

In addition to the monetary award, BioSure has been ordered to immediately:


Stop making, using, offering for sale, or selling the BioSure HIV Self Test.

Transfer all regulatory approvals and filings related to the BioSure HIV Self Test to Chembio.

Stop using the BioSure HIV Self Test name.

Stop making, using, offering for sale, or selling components or other materials developed for the bundled products as defined in the distribution agreement, as well as any other design packaging or labeling associated with the bundled products.

Stop using all marketing and promotional materials in connection with the BioSure HIV Self Test name.

Instruct BioSure’s contract manufacturer to return certain materials to BioSure, including any Chembio confidential information and trade secrets within the manufacturer’s possession.

Return all files and records regarding the BioSure HIV Self Test to Chembio.

Stop using any results, conclusions, or data associated with any studies or performance evaluations related to the BioSure HIV Self Test.

“We are pleased with the arbitration’s outcome and believe the tribunal reached the correct decision,” stated Richard Eberly, President and Chief Executive Officer of Chembio Diagnostics, Inc.  “Chembio’s confidential information and trade secrets are very important to Chembio, and this case was about protecting that information.”


Chembio was represented by Chris Centurelli, Mike Creta, and John Gavin of K&L Gates LLP in the arbitration.

About Chembio Diagnostics
Chembio Diagnostics, Inc. is a leading diagnostics company focused on developing and commercializing point-of-care tests used for the rapid detection and diagnosis of infectious diseases, including sexually transmitted disease, insect vector and tropical disease, COVID-19 and other viral and bacterial infections, enabling expedited treatment.  Coupled with the company’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease.  The company’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers.  Learn more at www.chembio.com.

DPP and SURE CHECK are Chembio’s registered trademarks, and the Chembio logo is Chembio’s trademark. For convenience, these trademarks appear in this release without ® or ™ symbols, but that practice does not mean that Chembio will not assert, to the fullest extent under applicable law, its rights to the trademarks.

Contact:

Philip Taylor

Gilmartin Group

415-937-5406

investor@chembio.com