Document:

Non-Exclusive License Agmt - John Hopkins University

 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 *** 

*** percent (***%) of *** 
  

	***	 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 Agmt - University of Michigan

 EXHIBIT 10.13 

LICENSE AGREEMENT 

MICHIGAN FILE 492p2 TECHNOLOGY 

DIAGNOSTIC PRODUCT DISTRIBUTION LICENSE 

This License Agreement, effective as of the 15th day of March, 2006 (the “Effective Date”), entered into by Clinical Micro
Sensors, DBA Osmetech Molecular Diagnostics, a corporation incorporated in the State of California located at 757 South Raymond Avenue, Pasadena, California 91105, USA (“LICENSEE”), the Regents of the University of Michigan, a
constitutional corporation of the State of Michigan (“MICHIGAN”), and HSC Research and Development Limited Partnership, a partnership organized and subsisting under the laws of the Province of Ontario, Canada (“RDLP”). LICENSEE,
MICHIGAN and RDLP agree as follows: 
  

	1.	 BACKGROUND. 

  

	1.1	 Michigan (in part in the Howard Hughes Medical Institute (“HHMI”) laboratories at MICHIGAN) and the Research Institute of the Hospital for
Sick Children of Toronto, Ontario, Canada, (“HSC”) have conducted research relating to cystic fibrosis. As a result of that research, MICHIGAN arid RDLP have developed rights in the “Licensed Patent(s)” defined below.

  

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

  

	1.3	 MICHIGAN and RDLP have entered into a Memorandum of Agreement covering the Licensed Patent(s), consistent with which MICHIGAN and RDLP are entering
into this License Agreement jointly as the licensor of the Licensed Patent(s). 

  

	2.	 DEFINITIONS. 

  

	2.1	 “TECHNOLOGY”, as used in this Agreement, shall mean the information, manufacturing techniques, data, designs or concepts developed by
MICHIGAN and HSC, covering the gene for cystic fibrosis and uses thereof as covered by the claims of U.S. Patent Nos. 5,776,677 and 6,984,487 entitled “Cystic Fibrosis Gene.” 

 

	2.2	 “Parties”, in singular or plural usage as required by the context, shall mean LICENSEE, MICHIGAN 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 Nos. 5,776,677 and 6,984,487, entitled “Cystic Fibrosis Gene” and all foreign
equivalent patent applications and Patent Cooperation Treaty filings, and all patents issuing therefrom in which Michigan and/or RDLP has or acquires a property interest (currently including the applications listed in the Appendix I attached to this
Agreement). “Licensed Patent(s)” shall also include 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, 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 Patent(s) 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 Product(s) may be designed, manufactured, used and/or marketed under this Agreement, and
shall mean solely Product(s) 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 Product(s), or the use of Product(s), 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 Product(s); customary trade, quantity and cash discounts actually allowed and taken; excise, value-added, and sales taxes
actually paid by LICENSEE for Product(s); and shipping and handling charges actually paid by LICENSEE for Product(s). 

  

	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 or other governmental approvals to market Product(s). 

  

	3.	 GRANT OF LICENSE. 

  

	3.1	 MICHIGAN and RDLP hereby grant to LICENSEE a non-exclusive license under the Licensed Patent(s) 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, Product(s) designed and marketed solely for use in the Field of Use. 

 

	3.2	 MICHIGAN and RDLP reserve the right to license and use all aspects of the TECHNOLOGY and the Licensed Patent(s) for any use or purpose, including
the right to develop and produce Product(s). 

  

	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 MICHIGAN a one-time, non-creditable license issue fee of 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 MICHIGAN. 

  

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

 

	4.3	 The obligation to pay MICHIGAN 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 Patent(s) 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. 

 

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

	4.4	 LICENSEE shall pay to MICHIGAN an annual license maintenance fee. This annual fee shall accrue in the Royalty Quarter ending in March of the years
specified below, and shall be due and payable and included with the report for that quarter. 

If LICENSEE defaults in the payment of any annual license maintenance fee, and fails to remedy that default within sixty
(60) days after written notice of it by MICHIGAN, then this Agreement and the license rights conveyed herein shall terminate. 

The annual license maintenance fees shall be as follows: 

 

	 	(1)	 In 2006 and in each year thereafter during the term of this Agreement up to and including the year in which LICENSEE first obtains FDA approval or
other governmental approval to distribute or use Product(s) in the Field of Use: U.S. $***            . 

Also, notwithstanding (1) above (and in place of the amount therein listed, when applicable): 

 

	 	(2)	 In the first calendar year following the year in which LICENSEE obtains the approval described in (1) above, and in each year thereafter during
the term of this Agreement up to and including the year in which the First Diagnostic Sale occurs: U.S. $ ***        ; 

Also, notwithstanding (1-2) above (and in place of the amounts therein listed, when applicable): 

 

	 	(3)	 In the first calendar year following the First Diagnostic Sale: U.S. $ ***        ;

  

	 	(4)	 In the second year following the First Diagnostic Sale: U.S. $ ***        ; 

 

	 	(5)	 In the third year following the First Diagnostic Sale: U.S. $ ***        ; and 

 

	 	(6)	 In the fourth year following the First Diagnostic Sale, and in each year thereafter during the term of this
Agreement;            ***            . 

Each annual fee paid under (3-6) above may be credited by LICENSEE in full against all earned royalties otherwise to be
paid to MICHIGAN under Paragraph 4.2 for the calendar year in which the specific annual fee is paid. The year for which such credits against royalties may be taken includes the Royalty Quarter in which the annual fee accrues and the next three
Royalty Quarters. 
 Each annual fee paid under (1-2) above may be credited by LICENSEE in full against all
earned royalties otherwise to be paid to MICHIGAN under Paragraph 4.2 after such annual fee is paid. 
  

	4.5	 If LICENSEE takes any license(s), in a given country, under valid third party patents (i.e., those held by a licensor that is not an Affiliate of
LICENSEE) which would be 

  

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

	 	
infringed by the manufacture, use or sale of Product(s) in that country, then LICENSEE can deduct up to             *** percent (***%)
of the royalties otherwise due and payable in each Royalty Quarter under Paragraph 4.2 above for Net Sales in that country, until such time as LICENSEE has recovered an amount equal to
            *** percent (***%) of the royalty paid to such third parties; provided that in no event shall such deducted amounts be applied to reduce or require reimbursement of the annual
fees required under Paragraph 4.4. This Paragraph is not intended to imply an obligation upon MICHIGAN or RDLP to reimburse LICENSEE’S above-described third-party royalties; the rights granted to LICENSEE in this Paragraph shall not exceed the
ability of the above-described mechanism (i.e., a deduction of             ***% of royalties due upon Net Sales in the country in question) to reimburse such expenses. LICENSEE shall make
an accounting to MICHIGAN of all such third-party royalties, and all resulting deductions from royalties otherwise due and payable to MICHIGAN, as part of its reporting obligations under Article 5 below. 

 

	4.6	 If MICHIGAN and RDLP grant 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 license maintenance fees lower than those required of LICENSEE under this Agreement, then MICHIGAN and 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. 

  

	5.	 REPORTS. 

  

	5.1	 Within sixty (60) days after the close of (i) any Royalty Quarter in which a fee 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 MICHIGAN all royalties accruing to MICHIGAN
during such Royalty Quarter. Such quarterly reports shall indicate for each Royalty Quarter the gross sales and Net Sales of Product(s) 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 Product(s). In case no payment is due for any such
period, LICENSEE shall so report. 

  

	5.2	 LICENSEE covenants that it will promptly establish and consistently employ a system of specific nomenclature and type designations for Product(s) 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 MICHIGAN, or its auditors, when requested as to the
details concerning such nomenclature system as well as to all additions thereto and changes therein. 

  

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

	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 MICHIGAN,
for the purpose of verifying the amount of payments due and payable. 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 MICHIGAN shall be responsible for all expenses of such inspection, except that if such inspection reveals an underpayment of royalties to MICHIGAN 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 MICHIGAN.

  

	5.4	 The reports provided for hereunder shall be certified by an authorized representative of LICENSEE to be correct to the best of LICENSEE’S
knowledge and information. 

  

	6.	 TIMES AND CURRENCIES OF PAYMENTS. 

  

	6.1	 Payments accrued during each Royalty Quarter shall be due and payable in Ann Arbor, Michigan on the date each quarterly report is due (as provided
in Paragraph 5.1). LICENSEE will send the report and notice of payment by prepaid, certified or registered mail, return receipt requested, to the address for notices set forth in Article 19 herein. PAYMENTS shall be paid in United States dollars.
LICENSEE shall be responsible for the payment of charges imposed by any bank with respect to payments made to MICHIGAN under this agreement by direct deposit. LICENSEE agrees to make all payments due hereunder to MICHIGAN by direct deposit to
account: 

 ABA/Routing number: *** 

Beneficiary Account Number: *** 

SWIFT Code: *** 

Beneficiary Name: The Regents of the University of Michigan EFT 

Depository Account 

Bank Name: LaSalle Bank 

Bank Address: Troy, MI 48084 

reference: Office of Technology Transfer 
  

	6.2	 On all undisputed amounts outstanding and payable to MICHIGAN, interest shall accrue from the date such amounts are due and payable at
            *** percentage *** 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). 

  

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

	6.4	 Except as provided in the definition of Net Sales, all royalty payments to MICHIGAN 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.

  

	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
Product(s). 

  

	7.2	 LICENSEE agrees to use reasonable efforts to develop Product(s), obtain any government approvals necessary, and manufacture and sell Product(s) 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 Product(s) reasonably available to the public. 

 

	7.3	 Within thirty (30) days of the First Diagnostic Sale, LICENSEE shall report by written letter to MICHIGAN the date of that sale.

  

	8.	 PATENT APPLICATIONS AND MAINTENANCE. 

  

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

  

	8.2	 MICHIGAN 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 Patent(s) by third parties, LICENSEE agrees to promptly notify MICHIGAN
of such alleged infringement. 

  

	9.2	 MICHIGAN and RDLP, at their sole discretion and at their own expense, may initiate proceedings in response to alleged infringement of Licensed
Patent(s), but are under no obligation to do so. 

  

	10.	 NO WARRANTIES: LIMITATION ON MICHIGAN’S AND RDLP’S LIABILITY. 

 

	10.1	 MICHIGAN and RDLP, including their fellows, directors, officers, employees and agents, make 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 Product(s) will not infringe upon any patent or other rights not vested in MICHIGAN or RDLP. 

	10.2	 MICHIGAN, HSC AND RDLP, 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 PRODUCT(S). 

  

	10.3	 THE ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, MANUFACTURE, OFFERING FOR SALE, SALE OR OTHER DISPOSITION, AND PERFORMANCE OF PRODUCT(S) IS
ASSUMED BY LICENSEE AND AFFILIATES. In no event shall MICHIGAN, 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 MICHIGAN, HHMI, 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
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 or MICHIGAN (including HHMI laboratories), HSC, MICHIGAN, and RDLP make no
representations regarding how Product(s) 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, indemnity and hold harmless and shall require its Affiliates licensed hereunder to defend, indemnify and hold harmless
MICHIGAN, RDLP and HSC, as well as their fellows, officers, trustees, directors, 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 transferees of Product(s); 

 

	 	(2)	 The direct or indirect use by any person of Product(s) 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 Patent(s). 

 

	11.2	 MICHIGAN and RDLP shall be entitled to participate at their option and expense through counsel of their 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	 HHMI and its trustees, officers, employees, and agents (collectively, “HHMI Indemnitees”), will be indemnified, defended by counsel
reasonably acceptable to HHMI, and held harmless by the Licensee from and against any claim, liability, cost, expense, damage, deficiency, loss, or obligation, of any kind or nature (including, without limitation, reasonable attorneys’ fees and
other costs and expenses of defense) (collectively, “Claims”), based upon, arising out of, or otherwise relating to this License Agreement, including without limitation any cause of action relating to product liability. The previous
sentence will not apply to any Claim that is determined with finality by a court of competent jurisdiction to result from the gross negligence or willful misconduct of an HHMI Indemnitee. 

 

	11.4	 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 Product(s) manufactured, sold, licensed or otherwise distributed by LICENSEE and Affiliates. Such insurance policy must specify MICHIGAN, HHMI, RDLP and HSC, including their fellows, officers, trustees,
directors, Regents, agents and employees, as an additional insureds. LICENSEE shall furnish certificate(s) of such insurance to MICHIGAN, upon request. 

 

	12.	 TERM AND TERMINATION. 

  

	12.1	 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)	 MICHIGAN’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 MICHIGAN or RDLP accrued or to accrue because of any breach of default by another Party hereunder;

  

	 	(5)	 The general rights, obligations, and understandings of Articles 2, 10, 15, 17, 26, 27, and 28; 

	 	(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. 

  

	12.2	 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 Patent(s). 

  

	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 MICHIGAN specifying such default, then MICHIGAN and RDLP
may, at their 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 MICHIGAN 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 Product(s) 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 Product(s) or the design, development, manufacture, offering for sale, sale or other
disposition of Product(s), the license granted herein shall terminate immediately with respect to such Product(s) within the territory encompassed by such jurisdiction provided that 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 MICHIGAN and RDLP, which consent shall not be unreasonably withheld. Any attempt to assign this Agreement without such consent shall be void from the beginning. MICHIGAN and 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 and MICHIGAN 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 MICHIGAN. 

  

	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 furnished to MICHIGAN.

  

	15.	 LAWS AND REGULATIONS OF THE UNITED STATES AND CANADA; EXPORT. 

 

	15.1	 Activities under this Agreement shall be subject to all appropriate United States and 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), or otherwise applicable to LICENSEE’S or its Affiliates’ activities hereunder.

  

	15.3	 LICENSEE shall obtain, and shall require its Affiliates to obtain, such written assurances regarding export and re-export of technical data
(including Product(s) made by use of technical data) as may be required by the United States Office of Export Administration Regulations, and LICENSEE hereby gives such written assurances as may be required under those Regulations to MICHIGAN.

  

	15.4	 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 of External Affairs, Export Controls Division, or any authorization necessary for export from or import into Canada, 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, MICHIGAN and RDLP may, at their 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 MICHIGAN, HHMI, RDLP and
HSC in publicity or advertising without the prior written approval of that entity. MICHIGAN, HHMI, 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 patent notice as approved by
MICHIGAN or RDLP (when appropriate), such approval not to be unreasonably withheld. By way of example: “[Product Name] is produced and sold under license from the University of Michigan and HSC Research and Development Limited Partnership and
its use is permitted for diagnostic purposes only (U.S. Pat. Nos. 5,776,677 and 6,984,487). Any other use requires a license from the University of Michigan, Office of Technology Transfer, 3003 S. State St., Suite 2071, Ann Arbor, MI 48190-1280 and
HSC Research Development Limited Partnership, 555 University Avenue, Toronto, Ontario, Canada, M5G 1X8.” 
  

	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, 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

DBA Osmetech Molecular Diagnostics

757 South Raymond Avenue
	  	
		  	 Pasadena, CA 91105 USA
	  	
			
		  	 Attn: President
	  	
			
	 To MICHIGAN:
	  	 The University of Michigan

Technology Management Office

Wolverine Tower, Room 2071
	  	
		  	 3003 South State Street

Ann Arbor, MI 48109-1280

U.S.A.
	  	
			
		  	 Attn.: File No. 492p2
	  	

					
	 with a copy to:
	  	 HSC Research and Development

Limited Partnership

555 University Avenue
	  	
		  	 Suite 5270

Toronto, Ontario M5G 1X8

CANADA
	  	
			
		  	 Attn.: President
	  	

  

	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, MICHIGAN, 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 MICHIGAN or 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 MICHIGAN or RDLP. 

 

	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 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 LICENSEE to the other Parties shall be governed in all respects by the law of the
State of Michigan or the Province of Ontario (notwithstanding any provisions governing conflict of laws under such law to the contrary), depending upon the jurisdiction in which any action relating to the Agreement is brought; except that questions
affecting the construction and effect of any patent shall be determined by the law of the country in which the patent has been granted. 
  

	27.	 JURISDICTION AND FORUM. 

LICENSEE hereby consents to the jurisdiction of the courts of the State of Michigan over any dispute concerning this
Agreement or the relationship of the Parties. Should LICENSEE bring any claim, demand or other action against MICHIGAN or RDLP, including their fellows, officers, employees or agents, arising out of this Agreement or the relationship between the
Parties, LICENSEE agrees to bring said action only in an appropriate court of the State or Province of that Party. 
  

	28.	 HHMI THIRD PARTY BENEFICIARY STATUS 

HHMI is not a party to this Agreement and has no liability to any licensee, sublicensee, or user of anything covered by
this License Agreement, but HHMI is an intended third-party beneficiary of this License Agreement and certain its provisions are for the benefit of HHMI and are enforceable by HHMI in it own name. 

 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
	 	 3/22/06

  

													
	 FOR HSC RESEARCH AND

DEVELOPMENT THE LIMITED

PARTNERSHIP
	 	 FOR THE REGENTS OF

 
 UNIVERSITY OF MICHIGAN

					
	 By:
	 	 /s/ Stuart D. Howe
	 		 	 By 
	 	 /s/ Kenneth J. Nisbet

		 	 (authorized representative)
	 		 		 	 (authorized representative)

					
	  
 Typed Name
	 	 Stuart D. Howe, Ph.D.
	 		 	 Typed Name
	 	 Kenneth J. Nisbet

		 		 	 President

HSC Research and Development

Limited Partnership

555 University Avenue
	 		 	  
 Title

 
 Date
	 		 	 Executive Director

UM Technology Transfer
  

3/24/06

	 Title
	 		 	 Toronto, Ontario, M5G 1XB
	 		 		 		 	
						
	 Date
	 	 Mar 28, 06
	 		 		 		 	

 Appendix I: Patents and Fending Patent Applications 

January 16, 2006 
  

			
	 Title:
	  	 Cystic Fibrosis Gene

		
	 Inventors:
	  	 Tsui, Riordan, Collins, Rommens, Iannuzzi, Kerem, Drumm, Buchwald,

		
	 Abstract:
	  	 The cystic fibrosis gene and its gene product are described for both the normal and mutant forms. The genetic and protein information is used in developing
DNA diagnosis, protein diagnosis, carrier and patient screening, drug and gene therapy, cloning of the gene and manufacture of the protein, and development of cystic fibrosis affected animals.

Patent Applications Pending: 
  

					
	 Country
	  	 Number
	  	 Date Filed

			
	 United States
	  	 07/396,894
	  	 abandoned

	 United States
	  	 07/399,945
	  	 abandoned

	 United States
	  	 07/401,609
	  	 31/08/89

	 US Continuation
(6)
	  	 08/123,864
	  	 20/09/93

	 US Divisional
(7)
	  	 08/252,778
	  	 2/06/94

	 US Divisional
(3)
	  	 08/446,866
	  	 6/06/95

	 US Divisional
	  	 08/471,654
	  	 abandoned

	 US Divisional
	  	 08/466,897
	  	 abandoned

	 US Divisional
(5)
	  	 08/469,630
	  	 6/06/95

	 US Divisional
(4)
	  	 08/469,617
	  	 6/06/95

	 Ireland
(2)
	  	 3024/90
	  	 21/08/90

	 PCT
	  	 CA90/00267

WO 91/02796
	  	 20/08/90

7/03/91

	 EPO
(1)
	  	 90912428.1
	  	 20/08/90

	 Japan
	  	 511424/90
	  	 20/08/90

	 Japan Divisional
	  	 029998/04
	  	 5/03/04

	 Canada
	  	 2066204-2
	  	 20/08/90

	 Australia
(2)
	  	 61616/90
	  	 20/08/90

	  	  	 	  	 Date Issued

	
(1) EPO
 *
	  	 0489058
	  	 5/11/03

	
(2) Australia
 granted
	  	 647,408
	  	 25/01/94

	
(3) US
 issued
	  	 5,776,677
	  	 7/07/98

	
(4) US
 issued
	  	 6,201,107
	  	 13/03/01

	
(5) US
 issued
	  	 6,730,777
	  	 4/05/04

	
(6) US
 issued
	  	 6,984,487
	  	 10/01/06

	
(7) US
 issued
	  	 6,902,907
	  	 7/06/05

	
(8) Ireland
 granted
	  	 83911
	  	 6/05/05

  

	 	*	 Designated States include the following countries: Austria, Belgium, Switzerland and Liechtenstein, Germany, Denmark, Spain, France, United Kingdom,
Italy, Luxembourg, Netherlands, Sweden

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