Prepared By R.R. Donnelley Financial -- Form 8-K
 
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):  03/30/2012
 
GenMark Diagnostics, Inc.
(Exact name of registrant as specified in its charter)
 
Commission File Number:  001-34753
 
Delaware
  
27-2053069
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
5964 La Place Court, Suite 100
Carlsbad, CA 92008
(Address of principal executive offices, including zip code)
 
760-448-4300
(Registrant’s telephone number, including area code)
 
(Former name or former address, if changed since last report)
 
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))
 

 
Item 1.01.    Entry into a Material Definitive Agreement
 
Effective March 30, 2012, GenMark Diagnostics, Inc. ("GenMark"), through its subsidiary Clinical Micro Sensors, Inc., entered into a Heads of Agreement ("Agreement") with Advanced Liquid Logic, Inc. ("ALL"). The Agreement sets forth certain key terms to be contained in one or more definitive agreements to be negotiated and executed by GenMark and ALL, pursuant to which GenMark will be granted certain exclusive and non-exclusive licenses to use ALL's proprietary electro-wetting technology in conjunction with electrochemical detection in the development and commercialization of in-vitro diagnostics products. Following execution of the definitive agreements, GenMark has agreed to pay up to $3,000,000 in license fees, contingent milestone payments, and as part of an equity investment in ALL.

The foregoing description of the Agreement is qualified in its entirety by reference to the actual text of the Agreement, a copy of which GenMark expects to file with its Quarterly Report on Form 10-Q for the quarter ended March 31, 2012.

This Report includes forward-looking statements regarding events, trends and business prospects which may affect our future operating results and financial position, and such statements are subject to risks and uncertainties that could cause our actual performance, operating results and financial position to differ materially. Such forward-looking statements include, but are not limited to, statements concerning if and when definitive agreements with ALL may be negotiated and executed, the development and functionality of our products and the continued development of our technology, including in-vitro diagnostic platforms and assays, the future payment of milestone payments by the Company, the value of any securities to be purchased by Company, and the ability of the Company and its partners to manufacture products in a consistent, timely and cost-effective manner. Some of the risks and uncertainties associated with such forward-looking statements include, but are not limited to, risks related to our history of operating losses, our ability to successfully commercialize our products, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, ability to maintain gross margins, regulatory uncertainties regarding approval or clearance for our products, as well as other risks and uncertainties described under the 'Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

 
 
Item 7.01.    Regulation FD Disclosure
 
The information in 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 or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission.

On April 5, 2012, GenMark Diagnostics, Inc. issued a press release announcing that it entered into a heads of agreement with Advanced Liquid Logic, Inc. A copy of the press release is attached as Exhibit 99.1.

 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits
 

 

SIGNATURES
 
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.
 
           
GenMark Diagnostics, Inc.
 
 
Date: April 05, 2012
     
By:
 
/s/    Matthew Cohen

               
Matthew R. Cohen
               
SVP, General Counsel
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press release
GenMark and Advanced Liquid Logic enter into agreement to develop an all-electronic fully integrated diagnostic platform

GenMark and Advanced Liquid Logic enter into agreement to develop an all-electronic fully integrated diagnostic platform

CARLSBAD, Calif.--(BUSINESS WIRE)-- GenMark Diagnostics, Inc., (NASDAQ: GNMK) and Advanced Liquid Logic, Inc. (ALL) announced today that they have entered into a Heads of Agreement defining the key terms of a collaboration to develop an all-electronic, fully integrated in-vitro diagnostic platform bringing together ALL's proprietary electrowetting technology and GenMark's proprietary electrochemical detection.

"This partnership will allow us to leverage both companies' unique technologies and know-how, to deliver a digital sample-to-answer in-vitro diagnostic platform", said Hany Massarany, President and CEO of GenMark Diagnostic. "Our initial focus on multiplex molecular testing will be followed by efforts in other areas of diagnostics including protein detection and point-of-care testing, as we redefine industry standards for performance, reliability and ease of use with even the most complex of assays".

"We are excited to be working with the GenMark team and technology", said Richard West, President and CEO of Advanced Liquid Logic. "We bring a unique capability in comprehensive, electronically-driven sample preparation and we expect that it will integrate well with GenMark's eSensor® detection technology. This further validates that the fluid-handling flexibility of our platform can be integrated with multiple types of detection for a wide range of applications"

About GenMark Diagnostics, Inc.

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor® XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets three tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. A Respiratory Viral Panel (RVP) has been submitted to the FDA for 510(k) clearance. A number of other tests, including HCV Genotyping and 2C19, versions of which are available for research use only, and KRAS, are in development for IVD use. For more information, visit www.genmarkdx.com.

About Advanced Liquid Logic, Inc.

Advanced Liquid Logic is pioneering the next generation of microfluidics - Digital Microfluidics - with easy-to-use, cost-effective products in newborn screening and genomics sample preparation. Advanced Liquid Logic, a rapidly growing and profitable, privately-held company, also has products in development addressing in-vitro diagnostics and other markets. The Company's proprietary Digital Microfluidics enables precise and flexible manipulation of microdroplets using electrical fields. Advanced Liquid Logic is headquartered in Durham, NC with additional facilities in Grenoble, France. For more information please visit www.liquid-logic.com.

SAFE HARBOR STATEMENT

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding continued growth in sales of our diagnostic tests, the expansion of our diagnostic test menu, the development and functionality of our products and the continued development of our technology, are all subject to risks and uncertainties that could cause our actual performance, operating results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, our ability to successfully commercialize our products, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, ability to maintain gross margins, regulatory uncertainties regarding approval or clearance for our products, as well as other risks and uncertainties described under the "Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.