Document:

Amended and Restated Chemically Modified Enzymes Kit Patent License Agreement

 EXHIBIT 10.11 
 AMENDED AND RESTATED CHEMICALLY MODIFIED 
 ENZYMES KIT PATENT
LICENSE AGREEMENT 
 This License Agreement (“Agreement”) is made by and between Roche
Molecular Systems, Inc., a Delaware corporation having an office at 4300 Hacienda Drive, Pleasanton, California 94588, USA and F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland (hereinafter jointly referred to as
“ROCHE”) and Osmetech Molecular Diagnostics, 757 S. Raymond Avenue, Pasadena, CA 91105 (hereinafter referred to as “LCE”) hereafter collectively referred to as “The Parties”. 
 PREAMBLE 
 A. ROCHE owns or
controls certain Licensed Patents relating to chemically modified thermostable DNA polymerases, also known as “Hot Start Enzymes,” for use in polymerase chain reaction (“PCR”) technology. 
 B. LCE wants to incorporate Licensed Products into LCE’s Complete Diagnostic Kits for sale into the Licensed Field. 
 C. LCE wants to convey to End Users with the sale of LCE’s Complete Diagnostic Kits the right to use the Complete Diagnostic Kits in
the Licensed Field. 
 D. ROCHE is willing to grant to LCE a non-exclusive, world-wide license under its Licensed Patents in
order to allow LCE to incorporate Licensed Products into LCE’s Complete Diagnostic Kits for the Licensed Field, and to convey with the sale of such Complete Diagnostic Kits the right to use the Complete Diagnostic Kits in the Licensed Field.

 E. ROCHE and LCE previously entered into two Roche Chemically Modified Enzymes Patent License Agreements effective as of
May 14 and June 1, 2007 (the “Prior Agreements”) which Prior Agreements are each hereby amended, restated and superseded in their entirety by this Agreement. 
  

	1.	 Definitions 

 For the purpose of this Agreement, and solely for that purpose, the terms set forth herein shall be defined as follows: 
  

	1.1.	 “Affiliate” means with respect to a Party: (i) an organization, which directly or indirectly controls such Party; or
(ii) an organization, which is directly or indirectly controlled by such Party; or (iii) an organization, which is controlled, directly or indirectly, by the ultimate parent company of such Party. For purposes of this Section, control is
defined as owning fifty percent (50%) or more of the voting stock of a company or having otherwise the power to govern the financial and the operating policies or to appoint the management of an organization. The term “Affiliate” of
ROCHE shall not include Genentech, Inc., 1 DNA Way, South San Francisco, California 94080-4990, U.S.A. or Chugai Pharmaceutical Co., Ltd, 1-1, Nihonbasshi-Muromachi 2-chome, Chuo-ku Tokyo, 103- 8324, Japan, or the respective subsidiaries of said
companies. 

  

					
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 The term “Affiliate” includes organizations that meet any of the
above criteria at any time during the term of this Agreement and excludes organizations that cease to meet any of the above criteria at any time during the term of this Agreement. 
  

	1.2.	 “Complete Diagnostic Kit” means a LCE manufactured and trademarked kit covered by one or more Valid Claims of the Licensed Patents,
not covered by any ROCHE patents (including, but not limited to, U.S. Patent Nos. 5,210,015; 5,487,972; 5,804,375; 6,214,979; 5,994,056; 6,171,785 and their foreign counterparts) other than the Licensed Patents and dedicated for use for PCR in the
Licensed Field, and which LCE manufactured and trademarked kit is comprised of, at a minimum, the essential active reagents used in the practice of PCR for nucleic acid testing in the Licensed Field. For the avoidance of doubt and for the sake of
clarification, ASRs (Analyte Specific Reagents) are not Complete Diagnostic Kits. 

  

	1.3.	 “Effective Date” means the date on which the last signatory to this Agreement executes the Agreement. 

 

	1.4.	 “End User” means the customers, such as but not limited to doctors, hospitals, testing and research institutions, clinical or other
testing laboratories which perform diagnostic services or diagnostic testing using a Complete Diagnostic Kit. 

  

	1.5.	 “Licensed Field” means the field of use consisting of products or processes for the measurement, observation or determination of a
disease, disease state or genetic predisposition to a disease, by detecting, quantitating, distinguishing and/or monitoring nucleic acids in samples of material originating from a human being for the medical management for that human being, but
excluding (i) human identity testing, and (ii) the following human disease targets: Hepatitis A Virus, Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, Human Papilloma Virus and Parvovirus B19; provided, however, that
the said exclusions for the Human Papilloma Virus and Parvovirus B19 disease targets shall be limited to three (3) years from the Effective Date after which time the Human Papilloma Virus and Parvovirus B19 disease targets shall be included
within the Licensed Field subject to the royalty and other terms and conditions of this Agreement. 

  

	1.6.	 “Licensed Patents” means only the United States patents listed in Schedule A to this Agreement, and any patent issuing from
any divisional, continuation, or continuation-in- part application (but specifically excluding any patent issuing from any continuation-in- part application that has claims directed to subject matter patentably distinct from that disclosed or
claimed in the parent patent or application) of a listed patent; and any reissue, re-examination, extension, and corresponding foreign patents of any of the foregoing. 

  

	1.7.	 “Licensed Product” means a chemically modified thermostable DNA polymerase, the manufacture, use or sale of which is covered by one
or more Valid Claims of the Licensed Patents, sold by ROCHE (directly or through its distributor) or made and sold by a supplier licensed to make and sell the same. 

  

					
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	1.8.	 “Net Sales” means the gross invoice price for sales or transfers by LCE or its Affiliates to End Users of all Complete Diagnostic
Kits less deductions for returns (including withdrawals and recalls), sales rebates (i.e. price reduction), volume (i.e. quantity) discounts, sales taxes and other taxes directly linked to the sales in the countries concerned. In addition to this
above computed adjusted gross invoice price, all other expenses which may occur like custom duties, transportation costs and other direct expenses shall be covered by a lump deduction of
            ***             of the above computed adjusted gross invoice price. 

 In the event LCE or its Affiliates are unable to account for the gross invoice price for sales or transfers of Complete
Diagnostic Kits to End Users, the Net Sales shall be calculated as the gross invoice price for sales or transfers by LCE or its Affiliates to distributors, agents or wholesalers multiplied by 1.35. 
 In the event that (i) a Complete Diagnostic Kit is sold or transferred by LCE in such a way that the gross invoice price
for the sale or transfer of such Complete Diagnostic Kit is less than fair market value or does not fairly represent an actual independent arm’s- length transaction price for such Complete Diagnostic Kit, (ii) LCE transfers any Complete
Diagnostic Kit to an Affiliate which becomes an End User, or (iii) LCE uses any Complete Diagnostic Kit as an End User, then Net Sales shall be determined by reference to the gross invoice price for the Complete Diagnostic Kit sold or
transferred which would be applicable in an arm’s-length transaction with an unrelated third party by applying the average transaction price for Complete Diagnostic Kits in arms-length transactions for the previous twelve (12) month period
or, if no average transaction price of such Complete Diagnostic Kit is available for such period, at a reasonable value based upon the average transaction prices of other products available in the marketplace similar to such Complete Diagnostic Kit.

  

	1.9.	 “Territory” means world-wide. 

  

	1.10.	 “Valid Claim” means, in any country, the claim of an issued patent which (a) has not expired, (b) has not been
disclaimed, or (c) has not been revoked, held invalid or otherwise declared unenforceable by a tribunal of competent jurisdiction over such claim in such country from which no further appeal has or may be taken. Whether a patent claim is a
Valid Claim shall be determined on a country-by-country basis. 

  

	2.	 License 

  

	2.1.	 Subject to the terms and conditions of this Agreement, ROCHE hereby grants to LCE and its Affiliates a non-exclusive and non-transferable royalty
bearing license, without the right to sublicense, under the Licensed Patents in the Territory with the rights to: a) incorporate Licensed Products into LCE’s Complete Diagnostic Kits, b) make, offer to sell and sell such Complete Diagnostic
Kits in the Licensed Field, and c) convey with the sale of such Complete Diagnostic Kits the right to use the Complete Diagnostic Kits under the Licensed Patents in the Licensed Field. LCE and its Affiliate’s right to use

  

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

  

					
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Complete Diagnostic Kits includes the right to perform evaluations and validations of Complete Diagnostic Kits, but specifically does not include the right to use Complete Diagnostic Kits for the
performance of diagnostic services or testing, except that LCE and its Affiliates may use Complete Diagnostic Kits as End Users provided that royalties are paid thereon in accordance with Section 3.2. 

  

	2.2.	 The license granted by ROCHE herein to LCE and its Affiliates may be used solely for the purposes expressed above in Section 2.1. Except for
such grants, no further licenses or rights under the Licensed Patents or other patents owned or controlled by ROCHE are granted or given to LCE, its Affiliates or an End User in or under this Agreement, either expressly or by implication.

  

	3.	 Fees & Royalties 

  

	3.1.	 In consideration of the license granted in Article 2 of this Agreement, LCE has paid to ROCHE a non-creditable, non-refundable license issuance fee
of             ***            , which fee was paid pursuant to the Prior Agreements, the receipt of which is hereby acknowledged.

 The payment required above was made to ROCHE pursuant to the Prior Agreements to the
following account: 
 *** 
 *** 
 *** 
  

	3.2.	 As additional consideration for the rights and license granted herein, LCE shall pay to ROCHE royalties equal to
            ***             of its Net Sales during the term of this Agreement commencing as of the Effective Date of this
Agreement. 

 No royalties shall be paid on sales of Complete Diagnostic Kits between LCE and
its Affiliates, when the Affiliate is not the End User of such Complete Diagnostic Kit, but acts as LCE’s distributor. In such event royalties shall be due and payable on the Net Sales of such Complete Diagnostic Kit by such Affiliates to third
parties. 
  

	4.	 Reports, Payments, and Taxes 

  

	4.1.	 LCE shall, within sixty (60) days after December 31 and June 30 of each year, provide to the trustee mentioned in Schedule B
or another trustee as provided to LCE by ROCHE, a true and accurate royalty report. This report shall be in accordance with the royalty report form attached hereto as Attachment I. This report shall be on a U.S./ex-U.S. basis and shall give
such particulars of the business conducted by LCE during the preceding six (6) calendar months as are pertinent to an accounting for any royalty due under this Agreement, and shall include at least the following: 

 

	 	a)	 Separately itemized quantities of Complete Diagnostic Kits sold or otherwise transferred by LCE and its Affiliates during those six (6) months;

  

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

  

					
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	 	b)	 the cumulative gross invoice price of sales of each Complete Diagnostic Kit; 

  

	 	c)	 the Net Sales of each Complete Diagnostic Kit; and 

  

	 	d)	 the calculation of royalties due to ROCHE. If no royalties are due, it shall be so reported. 

 The correctness and completeness of each such report shall be attested to in writing by a responsible financial officer of
LCE. 
 Simultaneously with the delivery of each such royalty report to the trustee, LCE shall pay to the
trustee the royalty due for the period covered by such a report. Royalties due to ROCHE shall be paid on or before the due date to the address stated in Schedule B or to any address that ROCHE may advise LCE in writing. Each royalty report of LCE
will be released by the trustee to ROCHE after one (1) calendar year following the royalty reporting period. 
  

	4.2.	 Royalties payable hereunder shall be made without any deductions, except for withholding tax or any other fiscal deductions from time to time
required by the government of any country. All such payments shall be made in US Dollars, or in such other currency as ROCHE may from time to time direct (so far as legally permissible). Any necessary currency conversion shall be at the rate for
buying funds as quoted by the Wall Street Journal for the last business day of the period to which such payments relate. 

  

	4.3.	 Withholding tax, if any, levied by a government of any country of the Territory on payments made by LCE to ROCHE hereunder shall be borne by ROCHE.
LCE will pay such withholding tax to the respective taxing authorities and will deduct such amount from the royalty due to ROCHE. LCE shall use its best efforts to enable ROCHE to claim exception therefrom under any double taxation or similar
agreement in force and shall produce to ROCHE proper evidence of payments of all withholding taxes. 

  

	4.4.	 LCE shall keep a complete and accurate set of books and records relating to the quantity of Complete Diagnostic Kits shipped by or for LCE and its
Affiliates and the sales of Complete Diagnostic Kits by LCE and its Affiliates. Such books and records shall contain sufficient detail to substantiate the computation of the Net Sales of Complete Diagnostic Kits and the amount of royalties payable
under this Article 4 as well as all other information in the statement of account provided for herein, and shall be maintained by LCE for a period of not less than three (3) years from the date of such sales. 

  

	4.5.	 ROCHE shall be entitled, upon reasonable notice to LCE, to have such books and records inspected by an independent certified public accounting firm
retained by ROCHE and reasonably acceptable to LCE (which acceptance shall not be unreasonably withheld), provided that any such inspection occurs during LCE’s normal business hours not more than once in any calendar year. ROCHE also shall be
entitled to have the books and records of each of LCE’s Affiliates relating to the quantity of Complete Diagnostic Kits

  

					
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shipped by or for such Affiliate and such Affiliate’s sales of Complete Diagnostic Kits inspected, upon reasonable notice to such Affiliate, by an independent certified public accounting
firm retained by ROCHE and reasonably acceptable to such Affiliate, provided that any such inspection occurs during such Affiliate’s normal business hours not more than once in any calendar year. ROCHE agrees that all inspected information
shall be confidential to LCE and LCE’s Affiliates. 

  

	4.6.	 Any person conducting an inspection on behalf of ROCHE will be required to protect the confidentiality of such information and shall provide to
ROCHE a report only of the ultimate conclusions resulting from such inspection. Except as provided below, LCE shall pay promptly to ROCHE the amount of any royalties determined by such an inspection to be outstanding, along with interest accrued up
to and including the date of payment as provided in this Article 4. The costs of such an inspection shall be borne by ROCHE; provided, however, that, if such inspection determines that the royalties paid by LCE for any period were at least
            ***             less than the royalties otherwise due and payable, then LCE shall reimburse ROCHE for the costs of
such inspection. If such inspection determines that LCE has overpaid the amount of royalties otherwise due and payable for the inspected period, then ROCHE shall credit the amount of such overpayment to LCE against future royalties payable by LCE.

  

	4.7.	 If LCE fails to pay any amount specified under this Agreement after the due date thereof, the amount owed shall bear interest of
            ***             per month from the due date until paid, provided, however, that if this interest rate is held to be
unenforceable for any reason, the interest rate shall be the maximum rate allowed by law at the time the payment is due. 

  

	5.	 Term and Termination 

  

	5.1.	 Upon the execution of this Agreement by The Parties, the license under this Agreement shall commence on the Effective Date and, unless terminated
sooner as provided herein below or by mutual agreement, shall remain in effect until the last Licensed Patent having a Valid Claim will have expired. 

  

	5.2.	 Failure by either Party to this Agreement to comply with any of its obligations and conditions contained herein shall entitle the other Party to
give the Party in default written notice requiring it to cure such default. If the default is not cured within sixty (60) days after receipt of such notice, the notifying Party shall be entitled, without prejudice to any of its other rights
conferred on it by this Agreement, to terminate the entire Agreement by giving notice to take effect immediately. 

  

	5.3.	 Either Party may terminate this Agreement upon thirty (30) days written notice if, at any time, the other Party shall file a petition in
bankruptcy or insolvency before the courts or apply for an arrangement or for the appointment of a receiver or trustee for all of its assets or any part thereof, or if the other Party proposes a written agreement of composition or extension of its
debts or if the other Party shall be served with an

  

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

  

					
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involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after its filing, or if the other Party shall propose or
be a Party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of creditors. 

  

	5.4.	 LCE shall have the right to terminate this Agreement at any time for any reason upon ninety (90) days prior written notice.

  

	5.5.	 Termination of this Agreement for any reason shall be without prejudice to any other remedies to which either Party is or thereafter becomes
entitled hereunder and shall not affect any obligations or rights accrued before termination hereunder, provided however, that LCE shall be obligated to make all payments required by Section 3.1 regardless of the date of any such termination.

  

	5.6.	 Upon early termination of this Agreement, LCE shall notify ROCHE of the stock of Complete Diagnostic Kits LCE and its Affiliates have on hand at the
date of any such termination and LCE shall pay the royalty thereon, upon which LCE shall be entitled to sell the said stock in a period of three (3) months and in accordance with the requirements of Articles 4 and 6.

  

	5.7.	 The following provisions shall survive the expiration or termination of this Agreement: Article 3, Article 4, Section 5.5, and Articles 7, 8,
10, 11 and 12. 

  

	6.	 Labeling 

 LCE agrees that it shall mark conspicuously all Complete Diagnostic Kits made by or for it, and shall cause each of its Affiliates to mark or have marked conspicuously all Complete Diagnostic Kits with
the following legend or such alternative legend as shall be mutually agreed to by The Parties. LCE shall include the following notices or labels on all Complete Diagnostic Kits: 
 THE PURCHASE OF THIS PRODUCT GRANTS THE PURCHASER RIGHTS UNDER CERTAIN ROCHE PATENTS TO USE IT SOLELY FOR PROVIDING HUMAN IN VITRO DIAGNOSTIC SERVICES. NO GENERAL PATENT OR OTHER
LICENSE OF ANY KIND OTHER THAN THIS SPECIFIC RIGHT OF USE FROM PURCHASE IS GRANTED HEREBY. 
  

	7.	 Negation of Warranties and Indemnity 

 Nothing in this Agreement shall be construed as: 
  

	 	a)	 a warranty or representation by ROCHE as to the validity or scope of any Licensed Patent; 

  

	 	b)	 a warranty or representation that the sale of Complete Diagnostic Kits by LCE or its Affiliates and/or the use of such Complete Diagnostic Kits
(including Licensed Products) by LCE’s or its Affiliate’s customers is or will be free from infringement of patents not licensed hereunder; 

  

					
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	 	c)	 an obligation to bring or prosecute actions or suits against third parties for infringement of Licensed Patents; or 

  

	 	d)	 conferring by implication or otherwise any license or rights under any patents, know-how or other industrial property rights of ROCHE other than
expressly granted hereunder. 

  

	8.	 Confidentiality-Publicity 

  

	8.1.	 Information disclosed in the royalty reports to ROCHE by LCE in connection with this Agreement shall be considered confidential and proprietary and
ROCHE shall not disclose the same to any third party, and shall hold them in confidence for a period of five (5) years and will not use them other than as permitted under this Agreement, provided, however, that any information which is orally
disclosed to ROCHE shall not be considered confidential and proprietary. 

  

	8.2.	 The above obligations of confidentiality shall not be applicable to the extent: 

  

	 	a)	 such information is general public knowledge or, after disclosure hereunder, becomes general or public knowledge through no fault of ROCHE;

  

	 	b)	 such information can be shown by ROCHE by its written records to have been in its possession prior to receipt thereof hereunder;

  

	 	c)	 such information is received by ROCHE from any third party for use or disclosure by ROCHE without any obligation to LCE, provided, however, that
information received by ROCHE from any third party funded by LCE (e.g. consultants, subcontractors, etc.) shall not be released from confidentiality under this exception; or 

  

	 	d)	 the disclosure of such information is required or desirable to comply with or fulfill governmental requirements, submissions to governmental bodies,
or the securing of regulatory approvals. 

  

	9.	 Most Favored Licensee 

 If after the Effective Date of this Agreement, ROCHE grants to any unrelated third party, a license of substantially the same scope as granted to LCE herein but under more favorable royalty rates than
those given to LCE under this Agreement, ROCHE shall promptly notify LCE of said more favorable royalty rates, and LCE shall have the right and option to substitute such more favorable royalty rates for the royalty rates contained herein. LCE’s
right to elect said more favorable royalty rates shall extend only for so long as and shall be conditioned on LCE’s acceptance of all the same conditions, favorable or unfavorable, under which such more favorable royalty rates shall be
available to such other third party. Upon LCE’s acceptance of all such terms of said third-party agreement, the more favorable royalty rates shall be effective as to LCE on the effective date of such other third party license agreement.
Notwithstanding the foregoing, in the event that ROCHE shall receive substantial other nonmonetary consideration, for example, such as intellectual property rights, as a part of the consideration for its granting of

  

					
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such license to a third party, then such consideration shall be taken into account for determining whether or not the third party has been granted more favorable royalty rates. 
  

	10.	 Miscellaneous 

  

	10.1.	 This Agreement and the license herein granted are personal to LCE and shall not be assignable or transferable by LCE unless LCE assigns or transfers
its rights or delegates its duties and obligations (in whole and not in part) under this Agreement to any third person which acquires all, or substantially all, of its assets and/or business relating to molecular diagnostics, provided that such
assignee or transferee duly and effectively assumes all of the obligations of LCE by an instrument reasonably satisfactory to ROCHE, and provided further, that in the case of LCE’s assignee or transferee, such assignee or transferee shall be
approved in writing by ROCHE prior to such assignment or transfer, which approval shall not be unreasonably withheld or delayed. Any assignment or transfer in violation of the provisions of this section shall be void and shall constitute a material
breach of this Agreement. 

  

	10.2.	 Effective as of the Effective Date, this Agreement amends, restates and supersedes the Prior Agreements in their entirety, provided however, that
any royalties that may have accrued under the Prior Agreements prior to the Effective Date shall be paid by LCE to ROCHE as provided in the Prior Agreements. This Agreement contains the entire agreement of the parties concerning its subject matter
and supersedes all previous agreements or understandings, whether written or oral, with respect to such subject matter. 

  

	10.3.	 No amendments or alterations of this Agreement shall be binding upon either Party unless in writing and duly signed by The Parties.

  

	10.4.	 All titles and captions in this Agreement are for convenience only and shall not be interpreted as having any substantive meaning.

  

	10.5.	 If any provision of this Agreement is held to be illegal, invalid or unenforceable in a final, unappealable order or judgment or under any present
or future law (such provision to be hereinafter referred to as an “Invalid Provision”), then such Invalid Provision shall be severed from this Agreement and shall be rendered inoperative. The Parties shall promptly negotiate in good
faith a lawful, valid and enforceable provision that is as similar in terms to such Invalid Provision as may be possible while giving effect to the future benefits and burdens accruing to The Parties hereunder; and the remaining provisions of this
Agreement shall remain binding on The Parties hereto. In the event that The Parties cannot agree on a provision to replace an Invalid Provision, then The Parties shall submit such disagreement for resolution in accordance with the procedures set
forth in Article 12 below. It is expressly agreed by The Parties that amounts previously paid by one Party to the other Party under this Agreement shall not be recoverable to the paying Party as part of the replacement of an Invalid Provision unless
this Agreement is invalidated within one (1) year from the Effective Date. 

  

					
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	10.6.	 No failure or delay on the part of either Party in the exercise of any power or right hereunder shall operate as a waiver thereof. No single or
partial exercise of any right or power hereunder shall operate as a waiver of such right or of any other right or power. 

 The waiver by any Party of a breach of any provision of this Agreement shall not operate or be construed as a waiver of any other or subsequent breach hereunder. 
  

	10.7.	 Wherever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean
“including without limitation” and “including but not limited to” (or “includes without limitation” and “includes but is not limited to”) regardless of whether the words “without limitation” or
“but not limited to” actually follow the term “including” (or “includes”). 

  

	10.8.	 Except where the context otherwise requires, wherever used, the singular shall include the plural and the word “or” is used in the
inclusive sense. 

  

	11.	 Notices 

  

	11.1.	 Any notice required or permitted to be given under this Agreement shall be considered properly given, upon receipt, if sent by registered mail or
personal courier delivery to the respective address of each Party as follows: 

  

			
	If to LCE:	  	 Osmetech Molecular Diagnostics
 757 S. Raymond Avenue
 Pasadena, California 91105
 USA
 Attention: General Counsel

		
	If to ROCHE:	  	 F. Hoffman-La Roche Ltd
 Grenzacherstrasse 124
 CH-4070 Basel
 Switzerland
 Attention: Diagnostic Division Licensing

		
	With a copy to:	  	 Roche Molecular Systems, Inc.
 4300 Hacienda Drive
 Pleasanton, California 94588
 USA
 Attention: Legal Department

		
	And a copy to:	  	 Roche Molecular Systems, Inc.
 4300 Hacienda Drive
 Pleasanton, California 94588
 USA
 Attention: Licensing Department

  

					
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	12.	 Arbitration and Governing Law 

  

	12.1.	 This Agreement shall be governed by and enforced in accordance with the laws of Switzerland. 

  

	12.2.	 In the event of any controversy or claim arising out of or relating to any provision of this Agreement or the breach thereof, The Parties shall try
to settle those conflicts amicably between themselves. 

  

	12.3.	 Should The Parties fail to agree, any controversy, dispute or claim which may arise out of or in connection with this Agreement or the breach,
termination or validity thereof shall be settled by final and binding arbitration pursuant to the Rules of Conciliation and Arbitration of the International Chamber of Commerce (Paris) as hereinafter provided: 

  

	 	a)	 The arbitration tribunal shall consist of one (1) or three (3) arbitrators. If The Parties cannot agree on one arbitrator each Party shall
nominate in the request for arbitration and the answer thereto one arbitrator, and the two (2) arbitrators so named will then jointly appoint a third arbitrator as chairman of the arbitration tribunal. If one Party fails to nominate an
arbitrator or, if The Parties’ arbitrators cannot agree on the person to be named as chairman within sixty (60) days, the court of arbitration of the International Chamber of Commerce shall make the necessary appointments for arbitrator or
chairman; 

  

	 	b)	 The arbitration proceedings shall be held in the English language. The place of arbitration shall be Zürich (Switzerland).

 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly
authorized officers as of the Effective Date. 
  

									
	 F. HOFFMAN-LA ROCHE LTD
	 		 		 	
					
	 By:
	 	 /s/ illegible
	 		 	 By:
	 	 /s/ illegible

	 Title:
	 	 Licensing Manager
	 		 	 Title:
	 	 Legal Counsel

	 Date:
	 	 02/26/08
	 		 	 Date:
	 	 02/27/08

			
	 ROCHE MOLECULAR SYSTEMS, INC.
	 		 	 OSMETECH MOLECULAR DIAGNOSTICS

					
	 By:
	 	 /s/ illegible
	 		 	 By:
	 	 /s/ Bruce A. Huebner

	 Title:
	 	 S.V.P. Business
	 		 	 Title:
	 	 President

	 Date:
	 	 2/20/08
	 		 	 Date:
	 	 2/18/08

  

	
	 Apprv’d As To Form
 RMS LAW DEPT.

	
	 /s/ LG

  

					
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	  	11	  	

 SCHEDULE A 
 U.S. Patent No. 5,677,152 — Issued October 14, 1997 (process and kit claims only) Nucleic Acid Amplification Using a Reversibly Inactivated Thermostable Enzyme

 U.S. Patent No. 5,773,258 — Issued June 30, 1998 (process and kit claims only) Nucleic Acid
Amplification Using a Reversibly Inactivated Thermostable Enzyme 
 U.S. Patent No. 6,127,155—Issued: October 3,
2000 (reaction mixture claims only) Stabilized Thermostable Nucleic Acid Polymerase Compositions Containing Non-Ionic Polymeric Detergents 
  

					
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	  	12	  	

 SCHEDULE B 
 At present Treureva AG, Zürich, Switzerland is the appointed trustee. All royalty reports due are to be sent either via mail or fax to the following address: 

Treureva AG 
 Mühlebachstrasse 25

 P.O. Box 131 
 CH-8024 Zürich

 Switzerland 
 To the attention of:
Mr. Reto Kuhl 
 Tel: +41 44 267 1717 
 Fax: +41 44 267 1711 
 E-mail: rkuhl@treureva.ch 
 All royalty payments due to ROCHE shall be wire transferred to the bank account as shown below: 
 *** 
 *** 
 *** 
  

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

  

					
	 Osmetech – Contract No. 17852
	  	13Non-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 
  

					
	LAP-JHU Ref. 9328	  		  	12/20/2006

			
	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)***             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             ***             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 
 *** 
 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: 
 *** 
 *** 
 *** 
 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 
 *** 
 *** 
 *** 

 

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

  

					
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 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	  	12/20/2006

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00170-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00170-of-00352.parquet"}]]