Document:

Non-Exclusive License Agreement

 EXHIBIT 10.12 

FINAL 
 NON-EXCLUSIVE
LICENSE AGREEMENT 
 BETWEEN 

THE JOHNS HOPKINS UNIVERSITY 

& 

CLINICAL MICRO SENSORS 

DBA OSMETECH MOLECULAR DIAGNOSTICS 

JHU Ref: 9328 
  

					
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	FINAL-JHU-OSMETECH	  	CONFIDENTIAL

  

 NON-EXCLUSIVE LICENSE AGREEMENT 

This Non-exclusive License Agreement (hereinafter referred to as the “Agreement”) is by and between The Johns
Hopkins University (hereinafter referred to as “JHU”), a corporation of the State of Maryland, having a principal place of business at 3400 N. Charles Street, Baltimore, Maryland 21218-2695, and Clinical Micro Sensors (hereinafter referred
to as “Company”), Doing Business As Osmetech Molecular Diagnostics, a corporation incorporated in the State of California, located at 757 South Raymond Avenue., Pasadena, CA 91105. 

 

	1.	 BACKGROUND 

  

	 	1.1	 In the course of a fundamental research program at JHU, a valuable invention entitled “CF Mutations in the CFTR Gene” (JHU Ref. 9328) was
developed by Drs. Haig H. Kazazian, Stylianos E. Antonarakis and Garry R. Cutting (hereinafter referred to as “Inventors”). 

  

	 	1.2	 JHU has acquired all right, title and interest, with the exception of certain retained rights by the United States Government, in said invention but
is without the capacity to commercially develop, manufacture and distribute products and methods which embody the invention. 

  

	 	1.3	 Company is interested in providing such commercial products and methods to third parties on a non-exclusive basis and agrees to comply with the
terms and conditions in this Agreement. 

 NOW THEREFORE, in consideration of the premises and
the mutual promises and covenants contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows: 

 

	2.	 DEFINITIONS 

All references to particular Exhibits and Paragraphs shall mean the Exhibits to, and Paragraphs of, this Agreement, unless
otherwise specified. For the purposes of this Agreement and the Exhibits hereto, the following words and phrases shall have the following meanings: 
  

	 	2.1	 “EFFECTIVE DATE” of this License Agreement shall mean April 11, 2006. 

 

	 	2.2	 “EXECUTION DATE” of this License Agreement shall mean the date the last party has executed this Agreement.

  

	 	2.3	 “JHU MARKER(S)” shall mean as used herein in either singular or plural form, cystic fibrosis genetic markers covered by PATENT
RIGHT(S). 

  

	 	2.4	 “LICENSED FIELD” shall mean bio-electric-microfluidic instrumentation/biochip cartridge for cystic fibrosis molecular diagnostic
market. 

  

					
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	 	2.5	 “LICENSED PRODUCT(S)” as used herein in either singular or plural shall mean any material, composition, JHU MARKER(S), nucleic acid
sequence, nucleic acid probe, nucleic acid primer, in vitro diagnostic test, and kit containing any or all of the above, or any other product, process or method, the manufacture, use or sale of which would constitute, but for the license granted to
Company pursuant to this Agreement, an infringement of a claim of PATENT RIGHT(S) (infringement shall include, but is not limited to, direct, contributory, or inducement to infringe). 

 

	 	2.6	 “LICENSED SERVICE(S)” as used herein in either singular or plural shall mean the performance on behalf of a third party of any
method or the manufacture of any product or the use of any product or composition which would constitute, but for the license granted to Company pursuant to this Agreement, an infringement of a claim of the PATENT RIGHT(S) (infringement shall
include, but not be limited to, direct, contributory or inducement to infringe). 

  

	 	2.7	 “NET SALES” shall mean gross sales revenues and fees billed by Company from the sale of LICENSED PRODUCT(S) less trade discounts
allowed, refunds, returns and recalls, and sales taxes In the event that Company sells a LICENSED PRODUCT(S) in combination with OTHER MARKER(S), the royalty rate for purposes of royalty payments on the combination shall be calculated by multiplying
the royalty rate as defined in Paragraph 4.3 by the fraction A/A+B where A is the number of JHU MARKER(S) and B is the number of OTHER MARKERS. In no event shall the royalty rate used to calculate royalty payments on the combination fall below
            ***%. In the event that Company sells a LICENSED PRODUCT(S) that does not combine OTHER MARKER(S) with JHU MARKER(S), the royalty rate for purposes of royalty payments under
Paragraph 4.3 is as provided in Exhibit A. 

  

	 	2.8	 “OTHER MARKER(S)” shall mean patented cystic fibrosis genetic markers licensed by Company from THIRD PARTY or THIRD PARTIES, and on
which Company must pay a royalty. 

  

	 	2.9	 “NET SERVICE REVENUES” shall mean gross service revenues and fees billed by Company for the performance of LICENSED SERVICE(S) less
sales and/or use taxes imposed upon and with specific reference to the LICENSED SERVICE(S) in combination with OTHER MARKER(S). In the event that Company sells a LICENSED SERVICE(S) in combination with OTHER MARKERS, the royalty rate for purposes of
royalty payments on the combination shall be calculated by multiplying the royalty rate as defined in Paragraph 4.3 by
                ***            . In no event shall the royalty rate used to calculate the royalty payment on
the combination fall below             ***%. In the event that Company sells a LICENSED SERVICE that does not combine OTHER MARKER(S) with JHU MARKER(S), the royalty rate for purposes of
royalty payments under Paragraph 4.3 is as provided in Exhibit A 

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

					
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	 	2.10	 “PATENT RIGHT(S)” shall mean the U.S. Patent No. 5,407,796, issued April 18, 1995 for Cystic Fibrosis Mutation Cluster to
Cutting et al. and any reissues based thereof. 

  

	 	2.11	 “NON-EXCLUSIVE LICENSE” shall mean a grant by JHU to Company of its entire right and interest in the PATENT RIGHT(S) subject to
rights retained by the United States Government, if any, in accordance with the Bayh-Dole Act of 1980 (established by P.L. 96-517 and amended by P.L. 98-620, codified at 35 USC § 200 et. seq. and implemented according to 37 CFR Part 401), and
subject to the retained right of JHU to make, have made, provide and use for its and The Johns Hopkins Health Systems’ purposes LICENSED PRODUCT(S) and LICENSED SERVICE(S), including the ability to distribute any biological material disclosed
and/or claimed in PATENT RIGHT(S) for nonprofit academic research use to non-commercial entities as is customary in the scientific community. 

  

	3.	 GRANT 

  

	 	3.1	 License Granted: Subject to the terms and conditions of this Agreement, JHU hereby grants to Company a non-transferable NON-EXCLUSIVE LICENSE
to make, have made, use, import, offer for sale and sell the LICENSED PRODUCT(S) and the LICENSED SERVICE(S) in the United States under the PATENT RIGHT(S) in the LICENSED FIELD from the EFFECTIVE DATE of this Agreement. Nothing in this Agreement is
intended to preclude the export or the sale for export of LICENSED PRODUCT(S) to be made, used and sold in countries where no subsisting and unexpired claims of PATENT RIGHT(S) exist, and on which royalties shall be paid as provided in Paragraph 4.3
of this Agreement due to the manufacture of LICENSED PRODUCT(S) under any subsisting and unexpired claims of PATENT RIGHT(S). 

  

	 	3.2	 No Sublicensing: Company shall not sublicense to others under this Agreement, nor extend the rights granted hereunder to any affiliated
company. 

  

	 	3.3	 Bulk Sales: Company may make bulk sales of LICENSED PRODUCT(S) only upon written authorization of JHU. Company may not transfer the LICENSED
PRODUCT(S) to third parties, except to a contract party making LICENSED PRODUCT(S) solely for Company’s benefit. 

  

	4.	 PAYMENTS, ROYALTY AND REPORTING 

  

	 	4.1	 Licensing Fee: Company shall pay JHU within thirty (30) days of the EXECUTION DATE a license fee as set forth in Exhibit A. JHU
shall not submit an invoice for the license fee, which is non-refundable and shall not be credited against royalties or other fees. 

  

	 	4.2	 Minimum Annual Royalties: Company shall pay to JHU minimum annual royalties as set forth in Exhibit A. These minimum annual royalties
shall be due, without invoice from JHU, within thirty (30) days of each anniversary of the 

  

					
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EFFECTIVE DATE beginning with the first anniversary. Running royalties accrued under Paragraph 4.3 and paid to JHU during the one year period preceding an anniversary of the EFFECTIVE DATE shall
be credited against the minimum annual royalties due on that anniversary date. 

  

	 	4.3	 Initial Running Royalties: Company shall pay to JHU initial running royalties accrued for each LICENSED PRODUCT(S) sold and each LICENSED
SERVICE(S) provided based on NET SALES and NET SERVICE REVENUES respectively, on and after the EFFECTIVE DATE by Company to the EXECUTION DATE, as set forth in Exhibit A. These initial running royalties shall be due within thirty
(30) days of the EXECUTION DATE and will represent sales of LICENSED PRODUCT(S) or LICENSED SERVICE(S) occurring between the EFFECTIVE DATE to the EXECUTION DATE. All non-US taxes related to LICENSED PRODUCT(S) and LICENSED SERVICE(S) sold
under this Agreement shall be paid by Company and shall not be deducted from royalty or other payments due to JHU. 

  

	 	4.4	 Royalties: Company shall pay to JHU, a running royalty as set forth in Exhibit A, for each LICENSED PRODUCT(S) manufactured or sold
under any subsisting or unexpired claims of PATENT RIGHT(S) on EXECUTION DATE if not previously paid by Company to JHU under Paragraph 4.3 and subsequent to the EXECUTION DATE, such royalty that is based upon NET SALES for the term of this Agreement
and for each LICENSED SERVICE(S) provided by Company based on LICENSED PRODUCT(S) manufactured or sold under any subsisting or unexpired claims of PATENT RIGHT(S), such royalty that is based upon NET-SERVICE REVENUES for the term of this Agreement.
Such payments shall be made quarterly. All non-US taxes related to LICENSED PRODUCT(S) and LICENSED SERVICE(S) sold under this Agreement shall be paid by Company and shall not be deducted from royalty or other payments due to JHU.

  

	 	4.5	 Reporting and Payments: Company shall provide to JHU within thirty (30) days of the EXECUTION DATE of this Agreement, an initial written
report of the amount of LICENSED PRODUCT(S) sold and LICENSED SERVICE(S) provided, the total NET SALES and NET SERVICE REVENUES of such LICENSED PRODUCT(S) and LICENSED SERVICE(S), and the running royalties due to JHU as a result of NET SALES and
NET SERVICE REVENUES by Company after the EFFECTIVE DATE and on and before the EXECUTION DATE of this Agreement. Thereafter, Company shall provide to JHU within thirty (30) days of the end of each calendar quarter after the EFFECTIVE DATE of
this Agreement, a written report to JHU of the amount of LICENSED PRODUCT(S) sold and LICENSED SERVICE(S) provided, the total NET SALES and NET SERVICE REVENUES of such LICENSED PRODUCT(S) and LICENSED SERVICE(S), and the running royalties due to
JHU as a result of NET SALES and NET SERVICE REVENUES by Company. Payment of any such royalties due shall accompany such report. The report of sales and royalties due shall be substantially in the format of the sales and royalty report form given in
Exhibit B. 

  

					
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	 	4.6	 Late Payments: In the event that any payment due hereunder is not made when due, the payment shall accrue interest beginning on the tenth (10
th) day following the due date thereof, calculated at
the annual rate of the sum of (a)*** percent (***%) plus (b) the prime interest rate quoted by The Wall Street Journal on the date said payment is due, the interest being compounded on the last day of each calendar quarter, provided, however,
that in no event shall said annual interest rate exceed the maximum legal interest rate for corporations. Each such royalty payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall
not negate or waive the right of JHU to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment. 

 

	 	4.7	 Records: The Company shall make and retain, for a period of three (3) years following the period of each report required by Paragraph
4.5, true and accurate records, files and books of account containing all the data reasonably required for the full computation and verification of sales and other information required in Paragraph 4.5. Such books and records shall be in accordance
with generally accepted accounting principles consistently applied. The Company shall permit the inspection and copying of such records, files and books of account by JHU or its agents during regular business hours upon ten (10) business
days’ written notice to the Company. Such inspection shall not be made more than once each calendar year. All costs of such inspection and copying shall be paid by JHU, provided that if any such inspection shall reveal that an error has been
made in the amount equal to             *** percent (***%) or more of such payment, such costs shall be borne by the Company. 

 

	 	4.8	 Non-Arms Length Transactions: In order to insure JHU the full royalty payments contemplated hereunder, the Company agrees that in the event
any LICENSED PRODUCT(S) shall be sold to an affiliated company or to a corporation, firm or association with which Company shall have any agreement, understanding or arrangement with respect to consideration (such as, among other things, an option
to purchase stock or actual stock ownership, or an arrangement involving division of profits or special rebates or allowances) the royalties to be paid hereunder for such LICENSED PRODUCT(S) shall be based upon the greater of: 1) the net selling
price at which the purchaser of LICENSED PRODUCT(S) resells such product to the end user, 2) the NET SERVICE REVENUES received from using the LICENSED PRODUCT(S) in providing a service, 3) the fair market value of the LICENSED PRODUCT(S) or 4) the
net selling price of LICENSED PRODUCT(S) paid by the purchaser. 

  

	 	4.9	 Method of Payment: All payments under this Agreement shall be made in U.S. Dollars by either check or wire transfer.

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

					
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	 	4.10	 Payment Information: All payments from Company to JHU shall be sent to: 

Director 

Johns Hopkins Technology Transfer 

The Johns Hopkins University 

100 N. Charles Street 

5th
 Floor Baltimore, MD 21201 
 Attn: Agreement
#3491 
  
 or such other addressee which JHU
may designate in writing from time to time. Checks are to be made payable to “The Johns Hopkins University”. Wire transfers may be made through: 

Bank of America 

NY, NY 

Wire info: 

Johns Hopkins University Central Lockbox 

Transit/Routing/ABA number: *** 

Account number: *** 

Type of account: Depository 

Reference: JHU Tech Transfer 

(JHU Ref. 9328) 

Attn: Financial Manager 

If needed for international wires: 

SWIFT code: *** 

CHIPS ABA number: None 

Company shall be responsible for any and all costs associated with wire transfers. 

 

	5.	 PATENT MATTERS 

  

	 	5.1	 Prosecution & Maintenance: JHU, at its sole option and discretion, shall file, prosecute and maintain all patents specified under
PATENT RIGHT(S). Title to all such patents and patent applications shall reside in JHU. JHU shall have full and complete control over all patent matters in connection therewith under the PATENT RIGHT(S). 

 

	6.	 TERM AND TERMINATION 

  

	 	6.1	 Expiration: The term of this Agreement shall commence on the EFFECTIVE DATE and shall continue until the date of expiration of the last to
expire patent within PATENT RIGHT(S). 

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

					
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	 	6.2	 Termination by Company: Company may terminate this Agreement and the license granted herein, for any reason, upon giving JHU ninety
(90) days written notice. 

  

	 	6.3	 Termination by JHU: JHU, at its option, may terminate this Agreement and the license granted herein if Company 1) has not advertised LICENSED
PRODUCT(S) or LICENSED SERVICE(S) by catalog or on its website as part of a nationwide sales effort in any period of four consecutive quarters or 2) has not made any sales of LICENSED PRODUCT(S) or provided a LICENSED SERVICE in any period of four
consecutive quarters. 

  

	 	6.4	 Unpaid Royalty/Reversion of Rights: Termination or expiration shall not affect JHU’s right to recover unpaid royalties prior to
termination or expiration. Upon termination or expiration, all rights in and to the licensed technology shall revert to JHU at no cost to JHU. 

  

	 	6.5	 Survival: All applicable provisions, including but not limited to Paragraphs 4.1 (Licensing Fee), 6.4 (Unpaid Royalty/Reversion of Rights),
9.3 (Severability), 9.4 (Use of Name), 9.5 (Disclaimer of Warranties), 9.6 (Indemnification), 9.7 (Product Liability), 9.12 (Binding Effect) and 9.13 (Governing Law) shall survive termination or expiration of this Agreement.

  

	7.	 DEFAULT 

  

	 	7.1	 Default & Termination: Upon breach or default of any term or condition of this Agreement by either party, the defaulting party shall
be given written notice of such default in writing by the party not in default. The defaulting party shall have a period of sixty (60) days after receipt of such notice to correct the default or breach. If the default or breach is not corrected
within said sixty (60) day period, the party not in default shall have the right to terminate this Agreement. 

  

	8.	 NOTICES 

  

	8.1	 Notice Information: All notices and/or other communications pertaining to this Agreement shall be in writing and sent certified mail, return
receipt requested, to the parties at the following addresses or such other address as such party shall have furnished in writing to the other party in accordance with this Paragraph 8.1: 

FOR JHU: 

Director 

Johns Hopkins Technology Transfer 

The Johns Hopkins University 

100 N. Charles Street 

5th Floor 

Baltimore, MD 21201 

Attn: JHU Ref.: 9328 
  

					
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 FOR Company: 

Edward O. Kreusser, Esq. 

VP, Intellectual Property and Legal Affairs 

Osmetech Molecular Diagnostics 

757 South Raymond Avenue, 

Pasadena, CA 91105 

Phone: (626) 463-2000 ext. 8017 

Email: ed.kreusser@osmetech.com 
  

	9.	 MISCELLANEOUS 

  

	 	9.1	 Audit: JHU shall have the right to audit any Company records related to this Agreement. 

 

	 	9.2	 Assignment: This Agreement is binding upon and shall inure to the benefit of JHU, its successors and assignees and shall not be assignable to
another party, except that the Company shall have the right to assign this Agreement to another party in the case of the sale or transfer by the Company of all, or substantially all, of its assets relating to the LICENSED PRODUCT(S), LICENSED
SERVICE(S) or PATENT RIGHT(S), to that party. 

  

	 	9.3	 Severability: In the event that any one or more of the provisions of this Agreement should for any reason be held by any court or authority
having jurisdiction over this Agreement, or over any of the parties hereto to be invalid, illegal or unenforceable, such provision or provisions shall be reformed to approximate as nearly as possible the intent of the parties, and if unreformable,
shall be divisible and deleted in such jurisdictions; elsewhere, this Agreement shall not be affected. 

  

	 	9.4	 Use of Name: The Company shall not use the name of The Johns Hopkins University or The Johns Hopkins Health System or any of its constituent
parts, such as the Johns Hopkins Hospital or any contraction thereof or the name of Inventors in any advertising, promotional, sales literature or fundraising documents without prior written consent from an authorized representative of JHU. Company
shall allow at least seven (7) business days notice of any proposed public disclosure for JHU’s review and comment or to provide written consent. 

 

	 	9.5	 Disclaimer of Warranties: JHU does not warrant the validity of any patents or that the practice under such patents, or the manufacture, use,
sale or import of LICENSED PRODUCT(S) or LICENSED SERVICE(S), shall be free from patent infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 9.5, COMPANY AGREES THAT THE PATENT RIGHT(S) IS PROVIDED “AS IS”, AND THAT JHU MAKES NO
REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCT(S) OR LICENSED SERVICE(S) INCLUDING THEIR SAFETY, 

 

					
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EFFECTIVENESS, OR COMMERCIAL VIABILITY. JHU DISCLAIMS ALL WARRANTIES WITH REGARD TO LICENSED PRODUCT(S) AND LICENSED SERVICE(S) UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL
WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF JHU AND INVENTORS, FOR
DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF JHU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR
IN CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE LICENSED PRODUCT(S) AND LICENSED SERVICE(S) UNDER THIS AGREEMENT. COMPANY ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY ANY PRODUCT MANUFACTURED, USED, OR SOLD BY
COMPANY WHICH IS A LICENSED PRODUCT OR LICENSED SERVICE AS DEFINED IN THIS AGREEMENT. 

  

	 	9.6	 Indemnification: JHU and the Inventors will not, under the provisions of this Agreement or otherwise, have control over the manner in which
Company or those operating for its account or third parties who purchase LICENSED PRODUCT(S) or LICENSED SERVICE(S) from any of the foregoing entities, practice the inventions of LICENSED PRODUCT(S) and LICENSED SERVICE(S). The Company shall
indemnify, defend with counsel reasonably acceptable to JHU, and hold JHU, The Johns Hopkins Health Systems, their representatives including but not limited to present and former regents, trustees, officers, Inventors, agents, faculty, employees and
students harmless as against any judgments, fees, expenses, or other costs arising from or incidental to any product liability or other lawsuit, claim, demand or other action brought as a consequence of the practice of said inventions by any of the
foregoing entities, whether or not JHU or said Inventors, either jointly or severally, is/are named as a party defendant in any such lawsuit. Practice of the inventions covered by LICENSED PRODUCT(S) or LICENSED SERVICE(S) by an agent or a third
party on behalf of or for the account of the Company, or by a third party who purchases LICENSED PRODUCT(S) or LICENSED SERVICE(S) from the Company, shall be considered the Company’s practice of said inventions for purposes of this Paragraph
9.6. The obligation of the Company to defend and indemnify as set out in this Paragraph 9.6 shall survive the termination of this Agreement and shall not be limited by any other limitation of liability elsewhere in the Agreement.

  

	 	9.7	 Product Liability: Prior to first commercial sale of any LICENSED PRODUCT(S) or LICENSED SERVICE(S) as the case may be in any particular
country, Company shall establish and maintain, in each country in which Company shall sell LICENSED PRODUCT(S) or LICENSED SERVICE(S), 

 

					
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product liability or other appropriate insurance coverage appropriate to the risks involved in marketing LICENSED PRODUCT(S) and/or LICENSED SERVICE(S) and will annually present evidence to JHU
that such coverage is being maintained. Upon JHU’s request, Company will furnish JHU with a Certificate of Insurance of each product liability insurance policy obtained. JHU shall be listed as an additional insured in Company’s said
insurance policies. If such Product Liability insurance is underwritten on a ‘claims made’ basis, Company agrees that any change in underwriters during the term of this Agreement will require the purchase of ‘prior acts’ coverage
to ensure that coverage will be continuous throughout the term of this Agreement. 

  

	 	9.8	 Compliance: The LICENSED PRODUCT(S) shall not be used in humans and will be stored, used, and disposed of in accordance with applicable law
and regulations. 

  

	 	9.9	 Marking: Company agrees that all package inserts for LICENSED PRODUCT(S) and packaging containing individual or combination LICENSED
PRODUCT(S) sold for the research reagent market by Company will be marked (a) FOR RESEARCH USE ONLY; NOT FOR USE IN DIAGNOSTIC APPLICATIONS and (b) with the number of the applicable patent licensed hereunder in accordance with United
States patent law. Company further agrees that all package inserts for LICENSED PRODUCT(S) and packaging containing individual or combination LICENSED PRODUCT(S) sold for the diagnostic market as analyte specific reagants by Company will be marked
in compliance with applicable regulations for analyte specific reagents (as defined in 21 CFR § 864.4020) and with the number of the applicable patent licensed hereunder in accordance with United States patent law. In the event of FDA approval
of LICENSED PRODUCT(S), Company further agrees that all product labels and package inserts for FDA-approved LICENSED PRODUCT(S) and packaging containing individual or combination LICENSED PRODUCT(S) sold for the diagnostic market by Company will be
marked (a) “FOR IN VITRO DIAGNOSTIC USE” and (b) with the number of the applicable patent licensed hereunder in accordance with United States patent law. 

 

	 	9.10	 Entire Agreement: This Agreement constitutes the entire understanding between the parties with respect to the obligations of the parties with
respect to the subject matter hereof, and supersedes and replaces all prior agreements, understandings, writings, and discussions between the parties relating to said subject matter. 

 

	 	9.11	 Amendment & Waiver: This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument
executed by the authorized officials of the parties or, in the case of a waiver, by the party waiving compliance. The failure of either party at any time or times to require performance of any provision hereof shall in no manner affect its right at
a later time to enforce the same. No waiver by either party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or of any other condition or term.

  

					
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	 	9.12	 Binding Effect: This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their
respective successors and permitted assigns. 

  

	 	9.13	 Governing Law: This Agreement shall be construed, and legal relations between the parties hereto shall be determined, in accordance with the
laws of the State of Maryland applicable to contracts solely executed and wholly to be performed within the State of Maryland without giving effect to the principles of conflicts of laws. Any disputes between the parties to the Agreement shall be
brought in the state or federal courts of Maryland. Both parties agree to waive their right to a jury trial. 

  

	 	9.14	 Duties of the Parties. JHU is not a commercial organization. It is an institute of research and education. Therefore, JHU has no ability to
evaluate the commercial potential of any PATENT RIGHT(S) or LICENSED PRODUCT(S) or other license or rights granted in this Agreement. It is therefore incumbent upon Company to evaluate the rights and products in question, to examine the materials
and information provided by JHU, and to determine for itself the validity of any PATENT RIGHT(S), its freedom to operate, and the value of any LICENSED PRODUCT(S) or LICENSED SERVICE(S) or other rights granted. 

 

	 	9.15	 Headings. Article headings are for convenient reference and are not a part of this Agreement. All Exhibits of this Agreement are herein
incorporated by reference into this Agreement. 

  

	 	9.16	 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which when taken together
shall be deemed but one instrument. 

 IN WITNESS WHEREOF the respective parties hereto have executed this
Agreement by their duly authorized officers on the date appearing below their signatures. 
  

									
	THE JOHNS HOPKINS UNIVERSITY	 		 	 CLINICAL MICRO SENSORS

DBA OSMETECH MOLECULAR
 DIAGNOSTICS

					
	By	 	 /s/ Wesley D. Blakeslee
	 		 	By	 	 /s/ Bruce A. Huebner

		 	Wesley D. Blakeslee	 		 	Name:	 	Bruce A. Huebner
		 	Acting Director	 		 	Title:	 	President
		 	Johns Hopkins Technology Transfer	 		 		 	
					
	Date:	 	12/29/2006	 		 	Date	 	12/20/06

  

					
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 EXHIBIT A. 

LICENSE FEES and ROYALTY 
  

	1.	 The licensing fee due under Paragraph 4.1 is *** dollars ($***). 

 

	2.	 The minimum annual royalty payment due under Paragraph 4.2 is *** dollars ($***). 

 

	3.	 The royalty rate payable under Paragraph 4.3 is: 

*** percent (***%) of NET SALES 

*** percent (***%) of NET SERVICE REVENUES 
  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

					
	LAP-JHU Ref. 9328	  	13 of 14	  	12/20/2006

			
	FINAL-JHU-OSMETECH	  	CONFIDENTIAL

  

 EXHIBIT B. 

QUARTERLY SALES & ROYALTY REPORT 

FOR LICENSE AGREEMENT BETWEEN 

OSMETECH AND THE JOHNS HOPKINS UNIVERSITY 

DATED 

APRIL 11, 2006 

FOR PERIOD OF
                     TO
                     

TOTAL ROYALTIES DUE FOR THIS PERIOD $             

 

													
	 PRODUCT

ID NO.
	 	 PRODUCT

NAME
	 	 *JHU REF.

NO.
	  	1ST COMMERCIAL
SALE DATE	  	TOTAL NET
SALES/
SERVICES	  	ROYALTY
RATE	  	AMOUNT
DUE
		 		 		  		  		  		  	
		 		 		  		  		  		  	
		 		 		  		  		  		  	
		 		 		  		  		  		  	
		 		 		  		  		  		  	
		 		 		  		  		  		  	
		 		 		  		  		  		  	

  

	*	 Please provide the JHU Reference Number 9328 

This report format is to be used to report quarterly royalty statements to JHU. It should be placed on Company letterhead
and accompany any royalty payments due for the reporting period. This report shall be submitted even if no sales are reported. 
  

					
	LAP-JHU Ref. 9328	  	14 of 14	  	12/20/2006License Agreement

 EXHIBIT 10.14 

FINAL – March 1, 2006 

LICENSE AGREEMENT: 

INTRONS AND EXONS OF THE CYSTIC FIBROSIS GENE 

AND MUTATIONS AT VARIOUS POSITIONS OF THE GENE 

This is an Agreement, effective as of the
15th day of March, 2006 (the “Effective Date”),
entered into by Clinical Micro Sensors, Inc., DBA Osmetech Molecular Diagnostics, a corporation incorporated in California, located at 757 S. Raymond Avenue, Pasadena, CA 91105 (including all affiliates licensed hereunder, hereinafter collectively
referred to as “LICENSEE”), and HSC RESEARCH AND DEVELOPMENT LIMITED PARTNERSHIP, a partnership organized and subsisting under the laws of the Province of Ontario, Canada (“RDLP”). LICENSEE and RDLP agree as follows: 

 

	1.	 BACKGROUND. 

  

	1.1	 The Research Institute of The Hospital for Sick Children, Toronto, Ontario, Canada, (“HSC”) has conducted research relating to cystic
fibrosis. As a result of that research, RDLP has developed rights, including potential patent rights, in the “Licensed Patent(s)” that are defined below. 

 

	1.2	 LICENSEE desires to obtain, and RDLP, consistent with its mission of education and research, desires to grant a license of the “Licensed
Patent(s)” on the terms and conditions listed below. 

  

	2.	 DEFINITIONS. 

  

	2.1	 “TECHNOLOGY”, as used in this Agreement, shall mean the information, manufacturing techniques, data, designs or concepts developed by HSC,
covering mutations in the gene for cystic fibrosis and uses thereof as encompassed by the claims of U.S. Patent No. 5,981,178 and U.S. Patent No. 6,001,588 entitled “Introns and Exons of the Cystic Fibrosis Gene and Mutations at
Various Positions of the Gene”. 

  

	2.2	 “Parties”, in singular or plural usage as required by the context, shall mean LICENSEE and/or RDLP. 

 

	2.3	 “Affiliate(s)” shall mean any individual, corporation, partnership, proprietorship or other entity controlled by, controlling, or under
common control with LICENSEE through equity ownership, ability to elect directors, or by virtue of a majority of overlapping directors, and shall include any individual, corporation, partnership, proprietorship or other entity directly or indirectly
owning, owned by or under common ownership with LICENSEE to the extent of fifty percent (50%) or more of the voting shares, including shares owned beneficially by such party. 

 

	2.4	 “Licensed Patent(s)” shall mean U.S. Patent No. 5,981,178, U.S. Patent No. 6,001,588 and PCT Patent Application
No. PCT/CA91/00009 entitled “Introns and Exons of the Cystic Fibrosis Gene and Mutations at Various 

 

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Positions of the Gene” and all foreign equivalent patent applications and Patent Cooperation Treaty filings, and all patents issuing therefrom, in which RDLP has or acquires a property
interest, the current list of such applications is attached herewith as Appendix I. “Licensed Patent(s)” shall also include any divisional, continuation, reissue, reexamination or extension of the above-described patent applications and
resulting patents, along with any extended or restored term, and any confirmation patent, registration patent, or patent of addition. 

  

	2.5	 “Valid Claim(s)” means any claim(s) in an unexpired patent or pending in a patent application included within the Licensed Patents which
has not been held unenforceable, unpatentable, or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid
or unenforceable through reissue or disclaimer. If in any country there should be two or more such decisions conflicting with respect to the validity of the same claim, the decision of the higher or highest tribunal shall thereafter control;
however, should the tribunals be of equal rank, then the decision or decisions upholding the claim shall prevail when the conflicting decisions are equal in number, and the majority of decisions shall prevail when the conflicting decisions are
unequal in number. 

  

	2.6	 “Product(s)” shall mean any product(s) whose manufacture, use or sale in any country would, but for this Agreement, comprise an
infringement, including contributory infringement, of one or more Valid Claims. 

  

	2.7	 “Field of Use” shall refer to the field for which Products may be designed, manufactured, used and/or marketed under this Agreement, and
shall mean solely Products to be used for the research of, diagnosis of and screening for the disease cystic fibrosis. 

  

	2.8	 “Net Sales” shall mean the sum, over the term of this Agreement, of all amounts received and all other consideration received (or, when in
a form other than cash or its equivalent, the fair market value thereof when received) by LICENSEE and its Affiliates from persons or entities due to or by reason of the sale or other distribution of Products, or the use of Products, including any
use by LICENSEE and Affiliates in the performance of services for their customers; less the following deductions and offsets, but only to the extent such sums are otherwise included in the computation of Net Sales, or are paid by LICENSEE and not
otherwise reimbursed: refunds, rebates, replacements or credits actually allowed and taken by purchasers for return of Products; customary trade, quantity and cash discounts actually allowed and taken; excise, value-added, and sales taxes actually
paid by LICENSEE for Products; and shipping and handling charges actually paid by LICENSEE for Products. 

If a Product is intended for the identification of more than one mutation associated with the disease cystic fibrosis,
then the Net Sales of the Product shall 
  

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be multiplied with the factor [a:b] where “a” is number of mutations that are identified by the Product and that are covered by a Valid Claim of the Licensed Patents and “b”
is the total number of mutations that are identified by the Product provided, however, that the maximum reduction in the calculation of Net Sales resulting from the above described multiplication factor shall be
            *** percent (***%). 
  

	2.9	 “Royalty Quarter(s)” shall mean the three-month periods ending on the last day of March, June, September and December of each
year. 

  

	2.10	 “Territory” means all countries of the world. 

 

	2.11	 “First Diagnostic Sale” shall mean the first sale of any Product (including any sale of a service using a Product in the Field of Use) by
LICENSEE or an Affiliate, other than for use in clinical trials being conducted to obtain FDA approval or other government approvals to market Products in accordance with the statutes of any other country, or subdivision thereof, in the Territory.

  

	3.	 GRANT OF LICENSE. 

  

	3.1	 RDLP hereby grants to LICENSEE a non-exclusive license under the Licensed Patents and TECHNOLOGY to make, have made, use (including use in the
performance of services for, by or on behalf of its customers), have used, import, market, and/or sell in the Territory, Products designed and marketed solely for use in the Field of Use. 

 

	3.2	 RDLP reserves the right to license and use all aspects of the TECHNOLOGY and the Licensed Patents for any use or purpose, including the right to
develop and produce Products. 

  

	3.3	 The license granted to LICENSEE herein shall be without the right to sublicense, except that LICENSEE may sublicense Affiliate(s) who agree to be
and are bound in writing to the terms and conditions of this Agreement to the same extent as LICENSEE. LICENSEE agrees to strictly monitor and enforce compliance with the terms and conditions of this Agreement by all Affiliate sublicensees.

  

	4.	 CONSIDERATION. 

  

	4.1	 LICENSEE shall pay to RDLP a one-time, non-creditable, license issue fee of
            *** United States Dollars (U.S. $***) forthwith following the Effective Date. Notwithstanding any other terms of this Agreement, this Agreement and the license granted hereunder
shall not become effective until such issue fee is received by RDLP. 

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

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	4.2	 LICENSEE shall also pay RDLP, with respect to each Royalty Quarter, a royalty equal to
            ***percent (***%) of the Net Sales of Products of LICENSEE and Affiliates during such Royalty Quarter. 

 

	4.3	 The obligation to pay RDLP a royalty under this Article 4 is imposed only once with respect to the same unit of Product regardless of the
number of Valid Claims or Licensed Patents covering the same; however, for purposes of determination of payments due hereunder, whenever the term “Product” may apply to a property during various stages of manufacture, use or sale, Net
Sales, as otherwise defined, shall be derived from the sale, distribution or use of such Product by LICENSEE or Affiliates at the stage of its highest invoiced value to unrelated third parties. 

 

	4.4	 LICENSEE shall pay to RDLP an annual minimum royalty commencing in the calendar year 2006 as follows: 

 

	 	(1)	 In 2006: US$***        ; and 

 

	 	(2)	 In 2007 and each year thereafter during the term of this Agreement: US$***            .

 This annual minimum royalty shall accrue in the Royalty Quarter ending in March of each
calendar year of the years specified above and shall be due and payable and included in the report for that quarter. Notwithstanding the foregoing, for the year 2006, such annual minimum royalty shall be due and payable on June 30, 2006. If
LICENSEE defaults in the payment of any annual minimum royalty, and fails to remedy that default within thirty (30) days after written notice of it by RDLP, then this Agreement and the license rights conveyed herein shall terminate. 

Each annual minimum royalty paid under 4.4 (1) to (2) above may be credited by LICENSEE in full against all
earned royalties otherwise to be paid to RDLP under Paragraph 4.2 for the calendar year in which the specific annual minimum royalty is paid. The year for which such credits under 4.1 (1) to (2) against earned royalties may be taken
includes the Royalty Quarter in which the annual minimum royalty accrues and the next three Royalty Quarters. 
  

	4.5	 If RDLP grants a license under the Licensed Patent(s) and in the Field of Use to any third party which is substantially the same as the license
granted to LICENSEE under Article 3 above, for all or any part of the Territory, but which requires a royalty rate or annual minimum royalty lower than those required of LICENSEE under this Agreement, then RDLP shall offer those terms to
LICENSEE for that part of the Territory, to be effective as of the effective date of the license to that third party. 

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

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	5.	 REPORTS. 

  

	5.1	 Within sixty (60) days after the close of (i) any Royalty Quarter in which the annual minimum royalty under Paragraph 4.4 accrues,
and (ii) each Royalty Quarter following the first Diagnostic Sale during the term of this Agreement (including the close of any Royalty Quarter immediately following any termination of this Agreement), LICENSEE shall report to RDLP all
royalties accruing to RDLP during such Royalty Quarter. Such quarterly reports shall indicate for each Royalty Quarter the gross sales and Net Sales of Products by LICENSEE and Affiliates, and any other revenues with respect to which payments are
due, and the amount of such payments, as well as the various calculations used to arrive at said amounts, including the quantity, description (nomenclature and type designation), country of manufacture and country of sale of Products. In case no
payment is due for any such period, LICENSEE shall so report. 

  

	5.2	 LICENSEE will promptly establish and consistently employ a system of specific nomenclature and type designations for Products so that various types
can be identified and segregated, where necessary, LICENSEE and Affiliates shall consistently employ such system when rendering invoices thereon and henceforth agree to inform RDLP, or its auditors, when requested as to the details concerning such
nomenclature system as well as to all additions thereto and changes therein. 

  

	5.3	 LICENSEE shall keep, and shall require its Affiliates to keep, true and accurate records and books of account containing data reasonably required
for the computation and verification of payments to be made as provided by this Agreement, which records and books shall be open for inspection upon reasonable notice during business hours by an independent certified accountant selected by RDLP.
Said right of inspection will exist for six (6) years from the date of origination of any such record, and this requirement and right of inspection shall survive any expiration or termination of this Agreement for one (1) year. The
independent certified accountant shall provide to RDLP only such information from LICENSEE’s books and records as is necessary to verify the accuracy or degree of inaccuracy of the payments made under this Agreement. RDLP shall be responsible
for all expenses of such inspection, except that if such inspection reveals an underpayment of royalties to RDLP in excess of             *** percent (***%) for any year, then said
inspection shall be at LICENSEE’s expense and such underpayment shall become immediately due and payable to RDLP. 

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

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	6.	 TIMES AND CURRENCIES OF PAYMENTS. 

  

	6.1	 Payments accrued during each Royalty Quarter shall be due and payable in Toronto, Canada on the date each quarterly report is due (as provided in
Paragraph 5.1), shall be included with such report and shall be paid in United States dollars. LICENSEE agrees to make all payments due hereunder to RDLP by direct deposit to account: 

Remit To: Bank of America, New York 

FEDWIRE: ABA        *** 

Fields BBK and BNF must be completed as follows: 

BBK:                  
          *** 
 (Fedwire tag 4100)    
  Canadian Imperial Bank of Commerce 

                    
                  460 University Avenue 

                    
                  Toronto, Ontario, Canada MSG 1V1 

BNF:
                           Beneficiary’s 7 digit account number: *** 

                    
                  Name of Beneficiary: 

                    
                  HSG RESEARCH DEVELOP LTD PART 

(Fedwire tag 4200) 
  

	6.2	 On all undisputed amounts outstanding and payable to RDLP, interest shall accrue from the date such amounts are due and payable at two percentage
points above the prime lending rate as established by the Chase Manhattan Bank, N. A., in New York City, New York, or at such lower rate as may be required by law. 

 

	6.3	 Where Net Sales are generated in foreign currency, such foreign currency shall be converted into its equivalent in United States dollars at the
exchange rate of such currency as reported (or if erroneously reported, as subsequently corrected) in the Wall Street Journal on the day that the sale is made by LICENSEE or Affiliates (or if not reported on that date, as quoted by the Chase
Manhattan Bank, N.A., in New York City, New York). 

  

	6.4	 Except as provided in the definition of Net Sales, all royalty payments to RDLP under this Agreement shall be without deduction for sales, use,
excise, personal property or other similar taxes or other duties imposed on such payments by the government of any country or any political subdivision thereof; and any and all such taxes or duties shall be assumed by and paid by LICENSEE.

  

	6.5	 Notwithstanding Article 6.4 of this Agreement, LICENSEE shall be entitled to withhold from payments and royalties due to RDLP under this
Agreement nonresident withholding taxes to the extent that LICENSEE is obliged by law to withhold in respect of such amounts payable to RDLP, provided that the minimum allowable tax rate as specified by agreement under any applicable international
tax convention is applied to such withholding taxes. The amount of all such taxes withheld shall be included in reports to RDLP under Article 5.1. 

 

	7.	 COMMERCIALIZATION. 

  

	7.1	 It is understood that LICENSEE has the responsibility to do all that is necessary for any governmental approvals to manufacture and/or sell
Products. 

  

	***	 Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

  

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	7.2	 LICENSEE agrees to use reasonable efforts to develop Products, obtain any government approvals necessary, and manufacture and sell Products at the
earliest possible date; and to effectively exploit, market and manufacture in sufficient quantities to meet anticipated customer demand and to make the benefits of the Products reasonably available to the public. 

 

	7.3	 Within forty-five (45) days of the First Diagnostic Sale, LICENSEE shall report by written letter to RDLP the date of that sale.

  

	7.4	 LICENSEE shall promptly inform RDLP of any patent applications or similar applications which cover any invention intended to be practiced through
coincident practice of Licensed Patent(s), filed by or on behalf of LICENSEE or Affiliates anywhere in the world. 

  

	7.5	 It is understood that a separate license agreement from RDLP (and its joint owner) for the technology encompassed by U.S. Patent No. 5,776,677,
divisional of U.S. Patent Application No. 08/123,864 which is a continuation of U.S. patent Application No. 08/401,609 entitled “Cystic Fibrosis Gene”, including all foreign equivalent patent applications and Patent Cooperation
Treaty filings, and all patents issuing therefrom, and any divisional, continuation, (excluding continuations-in-part), reissue, reexamination or extension of the above described patent applications and resulting patents, along with any extended or
restored term and any confirmation patent, or registration patent, may be required to manufacture, use (including use in the performance of services) and/or sell Product(s). 

The parties acknowledge and agree that the definitions of TECHNOLOGY and Licensed Patent(s) in this Agreement are not
intended to encompass the information, manufacturing techniques, data, designs or concepts covering the gene for cystic fibrosis and uses thereof as described by U.S. Patent No. 5,776,677 and all other related patent applications and patents as
described herein. LICENSEE acknowledges that it has thorough familiarity with the specifications and claims of U.S. Patent No. 5,776,677 and all other related patent applications and patents as described herein. The terms and conditions of this
Article 7.5 shall take precedence over all potentially conflicting or inconsistent terms and conditions of this Agreement. 
  

	8.	 PATENT APPLICATIONS AND MAINTENANCE. 

  

	8.1	 RDLP shall control all aspects of filing, prosecuting, and maintaining Licensed Patents, including foreign filings and Patent Cooperation Treaty
filings. RDLP may in its sole discretion decide to refrain from or to cease prosecuting or maintaining any of the Licensed Patents, including any foreign filing or any Patent Cooperation Treaty filing. 

 

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	8.2	 RDLP shall notify LICENSEE of any issuance of any Licensed Patent(s) and the Valid Claims included therein, and any lapse, revocation, surrender,
invalidation or abandonment of any Licensed Patent or Valid Claim. 

  

	9.	 INFRINGEMENT. 

  

	9.1	 If LICENSEE becomes aware of or reasonably suspects infringement of Licensed Patents by third parties, LICENSEE agrees to promptly notify RDLP of
such alleged infringement. 

  

	9.2	 RDLP, at its sole discretion and at its own expense, may initiate proceedings in response to alleged infringement of the Licensed Patent(s) but is
under no obligation to do so. On request by the LICENSEE, RDLP shall inform LICENSEE of any measures being taken in response to any particular event or allegation of infringement. 

 

	10.	 NO WARRANTIES; LIMITATION ON RDLP’S LIABILITY. 

 

	10.1	 RDLP, including its fellows, directors, officers, employees and agents, makes no representations or warranties that any Licensed Patent is or will
be held valid, or that the manufacture, use, sale or other distribution of any Products will not infringe upon any patent or other rights not vested in RDLP. 

 

	10.2	 RDLP AND HSC, INCLUDING THEIR FELLOWS, DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS, MAKE NO REPRESENTATIONS, EXTEND NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ASSUME NO RESPONSIBILITIES WHATEVER WITH RESPECT TO DESIGN, DEVELOPMENT, MANUFACTURE, USE, SALE OR OTHER DISPOSITION
BY LICENSEE OR AFFILIATES OF PRODUCTS. 

  

	10.3	 THE ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, MANUFACTURE, OFFERING FOR SALE, SALE, OR OTHER DISPOSITION AND PERFORMANCE OF PRODUCTS IS ASSUMED BY
LICENSEE AND AFFILIATES. In no event shall RDLP or HSC, including their fellows, directors, officers, employees and agents, be responsible or liable for any direct, indirect, special, incidental, or consequential damages or lost profits to LICENSEE,
Affiliates or any other individual or entity regardless of legal theory. The above limitations on liability apply even though RDLP or HSC, including their fellows, directors, officers, employees or agents, may have been advised of the possibility of
such damage. 

  

	10.4	 LICENSEE shall not, and shall require that its Affiliates do not, make any statements, representations or warranties or accept any liabilities or

  

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responsibilities whatsoever to or with regard to any person or entity which are inconsistent with any disclaimer or limitation included in this Article 10. 

 

	10.5	 REGARDLESS OF ANY RESEARCH OR TESTING THAT MAY HAVE BEEN DONE AT HSC, HSC AND RDLP MAKE NO REPRESENTATIONS REGARDING HOW PRODUCES) CAN OR SHOULD BE
USED IN THE DIAGNOSIS OF AND SCREENING FOR THE DISEASE CYSTIC FIBROSIS. 

  

	10.6	 IT IS UNDERSTOOD THAT THE TECHNOLOGY AND THE LICENSED PATENT(S) DO NOT IDENTIFY THE PRESENCE OF THE CYSTIC FIBROSIS DISEASE IN ALL CASES.

  

	11.	 INDEMNITY; INSURANCE. 

  

	11.1	 LICENSEE shall defend, indemnify and hold harmless and shall require its Affiliates licensed hereunder to defend, indemnify and hold harmless RDLP
and HSC, as well as their fellows, directors, officers, trustees, employees and agents, from and against any and all claims, demands, damages, losses, and expenses of any nature (including attorneys’ fees and other litigation expenses),
resulting from, but not limited to, death, personal injury, illness, property damage, economic loss or products liability arising from or in connection with, any of the following: 

 

	 	(1)	 Any manufacture, use, sale or other disposition by LICENSEE, Affiliates or their transferees of Products; 

 

	 	(2)	 The direct or indirect use by any person of Products made, used, sold or otherwise distributed by LICENSEE or Affiliates;

  

	 	(3)	 The use by LICENSEE or Affiliates of any invention included in the TECHNOLOGY or the Licensed Patents. 

 

	11.2	 RDLP shall be entitled to participate at its option and expense through counsel of its own selection, and may join in any legal actions related to
any such claims, demands, damages, losses and expenses under Paragraph 11.1 above; provided that LICENSEE will retain control over such legal actions, including any settlement discussions. 

 

	11.3	 LICENSEE shall purchase and maintain in effect a policy of product liability insurance covering all claims with respect to diagnostic testing for
cystic fibrosis using a Product and any Products manufactured, used, sold, licensed or otherwise distributed by LICENSEE and Affiliates. Such insurance policy must specifically enumerate and cover the obligations of Licensee in this Agreement to
defend, indemnify and hold RDLP and HSC, including their fellows, directors, officers, trustees, employees and agents harmless (in the policy or by written acknowledgement of the insurer). LICENSEE shall furnish certificate(s) of such insurance to
RDLP upon request. 

  

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	12.	 TERM AND TERMINATION. 

  

	12.1	 This Agreement will become effective on its Effective Date and, unless terminated under another, specific provision of this Agreement, will remain
in effect until and terminate upon the last to expire of Licensed Patents. 

  

	12.2	 Upon any termination of this Agreement, and except as provided herein to the contrary, all rights and obligations of the Parties hereunder shall
cease, except as follows: 

  

	 	(1)	 Obligations to pay royalties and other sums accruing hereunder up to the day of such termination; 

 

	 	(2)	 RDLP’s rights to inspect books and records as described in Article 5, and LICENSEE’s obligations to keep such records for the
required time; 

  

	 	(3)	 Obligations of defense and indemnity under Article 11; 

 

	 	(4)	 Any cause of action or claim of LICENSEE or RDLP accrued or to accrue because of any breach or default by another Party hereunder;

  

	 	(5)	 The general rights, obligations, and understandings of Articles 2, 10, 15, 17, 26 and 27; and 

 

	 	(6)	 All other terms, provisions, representations, rights and obligations contained in this Agreement that by their sense and context are intended to
survive until performance thereof. 

  

	12.3	 If LICENSEE shall at any time default in the payment of any royalty or the making of any report hereunder, or shall make any false report, or shall
commit any material breach of any covenant or promise herein contained, and shall fail to remedy any such default, breach or report within sixty (60) days after written notice thereof by RDLP specifying such default, then RDLP may, at its
option, terminate this Agreement and the license rights granted herein by notice in writing to such effect. Any such termination shall be without prejudice to any Party’s other legal rights for breach of this Agreement.

  

	12.4	 LICENSEE may terminate this Agreement by giving RDLP a notice of termination, which shall include a statement of the reasons, whatever they may be,
for such termination and the termination date established by LICENSEE, which date shall not be sooner than ninety (90) days after the date of the notice. Such notice shall be deemed by the Parties to be final. 

 

	12.5	 In the event LICENSEE shall at any time during the term of this Agreement deal with the TECHNOLOGY or Products in any manner which violates the
laws, regulations or similar legal authority of any jurisdiction including, but not limited to, the public health requirements relating to the TECHNOLOGY or Products or the design, development, manufacture, offering for sale, sale or other
disposition of Products, the license granted herein shall terminate immediately with respect to such Products within the territory encompassed by such jurisdiction; provided that

  

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LICENSEE has failed to take steps to cure such violation within sixty (60) days after receiving written notice from the applicable legal authority. 

 

	13.	 ASSIGNMENT. 

Due to the unique relationship between the Parties, this Agreement shall not be assignable by LICENSEE without the prior
written consent of RDLP, which consent shall not be unreasonably withheld. Any attempt to assign this Agreement without such consent shall be void from the beginning. RDLP shall not unreasonably withhold consent for LICENSEE to assign this Agreement
to a purchaser of all or substantially all of LICENSEE’s business. No assignment shall be effective unless and until the intended assignee agrees in writing with RDLP to accept all of the terms and conditions of this Agreement. Further,
LICENSEE shall refrain from pledging any of the license rights granted in this Agreement as security for any creditor. 
  

	14.	 REGISTRATION AND RECORDATION. 

  

	14.1	 If the terms of this Agreement, or any assignment or license under this Agreement are or become such as to require that the Agreement or license or
any part thereof be registered with or reported to a national or supranational agency of any area in which LICENSEE or Affiliates would do business, LICENSEE will, at its expense, undertake such registration or report. Prompt notice and appropriate
verification of the act of registration or report or any agency ruling resulting from it will be supplied by LICENSEE to RDLP. 

  

	14.2	 Any formal recordation of this Agreement or any license herein granted which is required by the law of any country, as a prerequisite to
enforceability of the Agreement or license in the courts of any such country or for other reasons, shall also be carried out by LICENSEE at its expense, and appropriately verified proof of recordation shall be promptly famished to RDLP.

  

	15.	 LAWS AND REGULATIONS OF CANADA; EXPORT 

  

	15.1	 Activities under this Agreement shall be subject to all appropriate Canadian laws and regulations now or hereafter applicable.

  

	15.2	 LICENSEE shall comply, and shall require its Affiliates to comply, with all provisions of any applicable laws, regulations, rules and orders
relating to the license herein granted and to the testing, production, transportation, export, packaging, labeling, sale or use of Product(s) in Canada, and in all other countries where LICENSEE shall make, have made, use, market or sell Produces),
or otherwise applicable to LICENSEE’S or its Affiliates’ activities hereunder. 

  

	15.3	 LICENSEE shall obtain, and shall require its Affiliates to obtain, such authorization regarding export and re-export of technical data (including
Product(s) made by use of technical data) as may be required by the Department 

  

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of External Affairs, Export Controls Division, and LICENSEE hereby gives written assurances as may be required under those Regulations to RDLP. 

 

	16.	 BANKRUPTCY. 

If during the term of this Agreement, LICENSEE shall make an assignment for the benefit of creditors, or if proceedings in
voluntary or involuntary bankruptcy shall be instituted on behalf of or against LICENSEE, or if a receiver or trustee shall be appointed for the property of LICENSEE, RDLP may, at its option, apply to the bankruptcy court to terminate this Agreement
or revoke the license herein granted. 
  

	17.	 PUBLICITY. 

LICENSEE agrees to refrain from using and to require Affiliates to refrain from using the name of RDLP and HSC in
publicity or advertising without the prior written approval of that entity. RDLP and HSC agree to refrain from using the name of LICENSEE and AFFILIATES in publicity or advertising without the prior written approval of LICENSEE. 

 

	18.	 PRODUCT MARKING. 

LICENSEE agrees to mark, and to require Affiliates to mark, Products with the appropriate U.S. patent notice as listed in
Appendix 1. 
  

	19.	 NOTICES. 

Any notice, request, report or payment required or permitted to be given or made under this Agreement by a Party shall be
given by sending such notice by certified or registered mail, return receipt requested, or by facsimile transmission confirmed by mail, to the address set forth below or such other address as such Party shall have specified by written notice given
in conformity herewith. Any notice not so given shall not be valid unless and until actually received, and any notice given in accordance with the provisions of this Paragraph shall be effective when mailed. 

 

			
	To LICENSEE:	  	 Clinical Micro Sensors, Inc.

DBA Osmetech Molecular Diagnostics
 757 South
Raymond Avenue
 Pasadena, CA 91105 USA
  

Attn: President

  

 12 

 FINAL – March 1, 2006 

 

			
	To RDLP:	  	 HSC RESEARCH AND DEVELOPMENT

LIMITED PARTNERSHIP
 555 University Avenue, Suite
5270
 Toronto, Ontario M5G 1X8
 CANADA

 Attn: President

Tel:  416-813-5982
 Fax: 416-813-5085

  

	20.	 INVALIDITY. 

In the event that any term, provision, or covenant of this Agreement shall be determined by a court of competent
jurisdiction to be invalid, illegal or unenforceable, that term will be curtailed, limited or deleted, but only to the extent necessary to remove such invalidity, illegality or unenforceability, and the remaining terms, provisions and covenants
shall not in any way be affected or impaired thereby. 
  

	21.	 ENTIRE AGREEMENT AND AMENDMENTS. 

This Agreement contains the entire understanding of the Parties with respect to the matter contained herein. The Parties
may, from time to time during the continuance of this Agreement, modify, vary or alter any of the provisions of this Agreement, but only by an instrument duly executed by authorized officials of LICENSEE and RDLP. 

 

	22.	 WAIVER. 

No waiver by a Party of any breach of this Agreement, no matter how long continuing or how often repeated, shall be deemed
a waiver of any subsequent breach thereof, nor shall any delay or omission on the part of a Party to exercise any right, power, or privilege hereunder be deemed a waiver of such right, power or privilege. 

 

	23.	 ARTICLE HEADINGS. 

The Article headings herein are for purposes of convenient reference only and shall not be used to construe or modify
the terms written in the text of this Agreement. 
  

	24.	 NO AGENCY RELATIONSHIP. 

The relationship between the Parties is that of independent contractor and contractees. LICENSEE shall not be deemed to be
an agent of RDLP in connection with the exercise of any rights hereunder, and shall not have any right or authority to assume or create any obligation or responsibility on behalf of RDLP. 

 

 13 

 FINAL – March 1, 2006 

 

	25.	 FORCE MAJEURE. 

No Party hereto shall be deemed to be in default of any provision of this Agreement, or for any failure in performance,
resulting from acts or events beyond the reasonable control of such Party, such as but not limited to, Acts of God, acts of civil or military authority, civil disturbance, war, strikes, fires, power failures, natural catastrophes or other
“force majeure” events. 
  

	26.	 GOVERNING LAW. 

This Agreement and the relationship of the Parties shall be governed in all respects by and construed in accordance with
the law of the Province of Ontario, Canada (notwithstanding any provisions governing conflict of laws under such law to the contrary); except that questions affecting the construction and effect of any patent shall be determined by the law of the
country in which the Licensed Patent has been granted. 
  

	27.	 JURISDICTION AND FORUM. 

LICENSEE hereby consents to the jurisdiction of the courts of the Province of Ontario, Canada over any dispute concerning
this Agreement or the relationship of the Parties. Should LICENSEE bring any claim, demand or other action against RDLP, its fellows, directors, officers, employees or agents, arising out of this Agreement or the relationship between the Parties,
LICENSEE agrees to bring said action only in the courts of the Province of Ontario. 
  

 14 

 FINAL – March 1, 2006 

 

 IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in triplicate
originals by their duly authorized officers or representatives. 
  

					
	FOR LICENSEE	 	
			
	By:	 	 /s/ Bruce A. Huebner
	 	
		 	(authorized representative)

							
				
	Typed Name	 	Bruce A. Huebner	 		 	

							
				
	Title	 	President	 		 	
				
	Date	 	3/16/06	 		 	
			
	FOR HSC RESEARCH AND DEVELOPMENT LIMITED PARTNERSHIP	 		 	
				
	By:	 	 /s/ Stuart D. Howe
	 		 	
		 	(authorized representative)	 		 	

							
				
	Typed Name	 	Stuart D. Howe, Ph.D.	 		 	

							
				
		 	 President
 HSC Research and
Development Limited Partnership
 555 University Avenue
	 		 	
	Title	 	Toronto, Ontario, M5G 1XB	 		 	
				
	Date	 	Mar 28, 06	 		 	

							
			
	FOR HSC RESEARCH AND DEVELOPMENT LIMITED PARTNERSHIP	 		 	 Second Signature not required

				
	By:	 	  
	 		 	 /s/ SDH

		 	(authorized representative)	 		 	

							
				
	Typed Name	 	  
	 		 	

							
				
	Title	 	  
	 		 	
				
	Date	 	  
	 		 	

  

 15 

 FINAL – March 1, 2006 

 

 Appendix I: Patents and Pending Patent Applications 

January 1, 2003 
  

			
	 Title:
	  	 Introns and Exons of the Cystic Fibrosis Gene and Mutations at Various Positions of the Gene

		
	 Inventors:
	  	Tsui, Rommens, Kerem,

 Patents Issued:

  

					
	 Country
	  	Number	  	Date Issued
	 U.S.
	  	5,981,178	  	Nov. 9, 1999
	 U.S.
	  	6,001,588	  	Dec. 14, 1999
	 EPO*
	  	0667900	  	May 23, 2001

  

	*	 includes United Kingdom, Germany and France 

Patent Applications Pending: 
  

					
	 Country
	  	Number	  	Date Issued
	 CDN #1
	  	2007699-2	  	12/01/90
	 CDN #2
	  	2011253-1	  	01/03/90
	 CDN #3
	  	2020817-1	  	10/07/90
	 PCT
	  	CA9100009	  	11/01/91
	 WO
	  	91/10734	  	25/07/91
	 CDN
	  	2073441-8	  	11/01/91

  

 16

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