Document:

Amended & Restated License Agmt - Harvard College

 EXHIBIT 10.8 

AMENDED AND RESTATED 

LICENSE AGREEMENT 

BETWEEN 
 PRESIDENT
AND FELLOWS OF HARVARD COLLEGE 
 AND 

CLINICAL MICRO SENSORS, INC 

Effective as of July 14, 1997 

Re: Harvard Case No(s). 1063 and 1339 

In consideration of the mutual promises and covenants set forth below, the parties hereto agree as follows: 

ARTICLE I 

BACKGROUND 

HARVARD has entered into an agreement, effective July 14, 1997 (“the License Agreement”), with LICENSEE
granting LICENSEE certain rights under PATENT RIGHTS. The parties hereto agree that this Amended and Restated License Agreement supercedes and replaces the July 14, 1997 License Agreement. 

ARTICLE II 

DEFINITIONS 

As used in this Agreement, the following terms shall have the following meanings: 

 

	2.1	 AFFILIATE: any company, corporation, or business (a) which owns or controls at least fifty percent (50%) of the voting stock or other
ownership of LICENSEE; or (b) of which LICENSEE owns or controls at least fifty percent (50%) of the voting stock or other ownership. Unless otherwise specified, the term LICENSEE includes AFFILIATES. 

 

	2.2	 EFFECTIVE DATE: shall mean July 14, 1997 

  

	2.3	 FIELD: shall mean all fields of use 

  

	2.4	 HARVARD: President and Fellows of Harvard College, a nonprofit Massachusetts educational corporation having offices at the Office for Technology and
Trademark Licensing, 124 Mt. Auburn Street, Suite 410 South, Cambridge, Massachusetts 02138. 

	2.5	 LICENSED PROCESSES: the processes covered by PATENT RIGHTS. 

 

	2.6	 LICENSED PRODUCTS: products covered by PATENT RIGHTS or products made or services provided in accordance with or by means of LICENSED PROCESSES.

  

	2.7	 LICENSEE: Clinical Micro Sensors, Inc a corporation organized under the laws of California having its principal offices at 101 Waverly Drive,
Pasadena, CA 91105. 

  

	2.8	 NET SALES: the amount billed, invoiced, or received (whichever occurs first) for sales, leases, or other transfers of LICENSED PRODUCTS, less:

  

	 	(a)	 customary trade, quantity or cash discounts and non-affiliated brokers’ or agents’ commissions actually allowed and taken;

  

	 	(b)	 amounts repaid or credited by reason of rejection or return; and 

 

	 	(c)	 to the extent separately stated on purchase orders, invoices, or other documents of sale, taxes levied on and/or other governmental charges made as
to production, sale, transportation, delivery or use and paid by or on behalf of LICENSEE or sublicensees. 

  

	 	(d)	 reasonable charges for delivery or transportation provided by third parties, if separately stated. 

NET SALES also includes the fair market value of any non-cash consideration received by LICENSEE or sublicensees for the
sale, lease, or transfer of LICENSED PRODUCTS. 
  

	2.9	 NON-COMMERCIAL RESEARCH PURPOSES: use of PATENT RIGHTS for academic research or other not-for-profit scholarly purposes which are undertaken at a
non-profit or governmental institution that does not use the PATENT RIGHTS in the production or manufacture of products for sale or the performance of services for a fee. 

 

	2.10	 NON-ROYALTY SUBLICENSE INCOME: Sublicense issue fees, sublicense maintenance fees, sublicense milestone payments, and similar non-royalty payments
made by sublicensees to LICENSEE on account of sublicenses pursuant to this Agreement. 

  

	2.11	 PATENT RIGHTS: United States patents and patent applications listed in Appendix A, including USSN Serial No. 08/312,388 filed 9/26/94, entitled
“Molecular Recognition at Surfaces Derivatized with Self Assembled Monolayers” and United States patent application entitled “Surface-Immobilized Nucleic Acid and Electron-Transfer Devices and Methods”, filed on 1/21/97, the
inventions described and claimed therein, and any divisions, continuations, continuations-in-part to the extent the claims are directed to subject matter 

	 	 
specifically described and dominated by the claims of the existing PATENT RIGHTS, patents issuing thereon or reissues thereof, and any and all foreign patents and patent applications
corresponding thereto, all to the extent owned or controlled by HARVARD. 

  

	2.12	 TERRITORY: Any and all countries for which PATENT RIGHTS exist. 

 

	2.13	 The terms “Public Law 96-517” and “Public Law 98-620” include all amendments to those statutes. 

 

	2.14	 The terms “sold” and “sell” include, without limitation, leases and other transfers and similar transactions.

 ARTICLE III 

REPRESENTATIONS 
  

	3.1	 HARVARD is sole owner by assignment from Drs. C. Bamdad, J. Strominger, G. Sigal and G. Whitesides of their entire right,
title and interest in United States Patent Application Serial No. 08/312,388 filed 9/26/94 entitled ‘Molecular Recognition at Surfaces Derivatized with Self Assembled Monolayers’ (H.U. Case #1063) and from Dr. C. Bamdad of
her entire right title and interest in United States Patent Application entitled ‘Surface-Immobilized Nucleic Acid and Electron Transfer Devices or Methods filed 1/21/97 (HU Case #1339) in the foreign patent applications corresponding thereto,
and in the inventions described and claimed therein. 

  

	3.2	 HARVARD has the authority to issue licenses under PATENT RIGHTS. 

 

	3.3	 HARVARD warrants that all intellectual property rights to HU Case nos. 1063 and 1339 are included in PATENT RIGHTS. 

 

	3.4	 HARVARD is committed to the policy that ideas or creative works produced at HARVARD should be used for the greatest possible public benefit, and
believes that every reasonable incentive should be provided for the prompt introduction of such ideas into public use, all in a manner consistent with the public interest. 

 

	3.5	 LICENSEE is prepared and intends to diligently develop the invention and to bring products to market which are subject to this Agreement.

  

	3.6	 LICENSEE is desirous of obtaining an exclusive license in the TERRITORY and in the FIELD in order to practice the above-referenced invention covered
by PATENT RIGHTS in the United States and in certain foreign countries, and to manufacture, use and sell in the commercial market the products made in accordance therewith, and HARVARD is desirous of granting such a license to LICENSEE in accordance
with the terms of this Agreement. 

 ARTICLE IV 

GRANT OF RIGHTS 
  

	4.1	 HARVARD hereby grants to LICENSEE and LICENSEE accepts, subject to the terms and conditions hereof an exclusive commercial license in the TERRITORY
and in the FIELD under PATENT RIGHTS to make and have made, to use and have used, to sell and have sold the LICENSED PRODUCTS, and to practice the LICENSED PROCESSES, for the life of the PATENT RIGHTS. Such licenses shall include the right to grant
sublicenses, subject to HARVARD’s review. In order to provide LICENSEE with commercial exclusivity for so long as the license under PATENT RIGHTS remains exclusive, HARVARD agrees that it will not grant licenses under PATENT RIGHTS to others
except as required by HARVARD’s obligations in paragraph 3.2(a)or as permitted in paragraph 3.2(b). 

  

	4.2	 The granting and exercise of this license is subject to the following conditions: 

 

	 	(a)	 HARVARD’s “Statement of Policy in Regard to Inventions, Patents and Copyrights,” dated March 17, 1986, Public Law 96-517, Public
Law 98-620, and HARVARD’s obligations under agreements with other sponsors of research. To the best of HARVARD’s knowledge, the only sponsor of the research from which PATENT RIGHTS arise is the federal government. Any right granted in
this Agreement greater than that permitted under Public Law 96-517, or Public Law 98-620, shall be subject to modification as may be required to conform to the provisions of those statutes. 

 

	 	(b)	 HARVARD reserves the right to make and use, and grant to others non-exclusive licenses to make and use for NON-COMMERCIAL RESEARCH PURPOSES the
subject matter described and claimed in PATENT RIGHTS. 

  

	 	(c)	 LICENSEE shall use diligent efforts to effect introduction of the LICENSED PRODUCTS into the commercial market as soon as practicable, consistent
with sound and reasonable business practice and judgment; thereafter, until the expiration of this Agreement, LICENSEE shall endeavor to keep LICENSED PRODUCTS reasonably available to the public. 

 

	 	(d)	 At any time after five (5) years from the EFFECTIVE DATE, HARVARD may terminate or render this license non-exclusive if, in HARVARD’s
reasonable judgment, the Progress Reports furnished by LICENSEE do not demonstrate that LICENSEE: 

  

	 	(i)	 has put the licensed subject matter into commercial use in the country or countries hereby licensed, directly or through a

  

 4 

	 	 
sublicense, and is not keeping the licensed subject matter reasonably available to the public, or 

 

	 	(ii)	 is engaged in research, development, manufacturing, marketing or sublicensing activity appropriate to achieving 3.3(d)(1), and

  

	 	(iii)	 has adhered directly or through a sublicensee to the following performance milestones: 

1. Within five (5) years from the effective date, LICENSEE shall have designed and built at least one prototype
device based on PATENT RIGHTS and shall provide HARVARD with documentation of such. 
 2. Within seven
(7) years from the effective date, LICENSEE shall be manufacturing at least one device based on PATENT RIGHTS and shall provide HARVARD with documentation of such. 

3. Within eight (8) years from the effective date, LICENSEE shall provide HARVARD with documentation of the
commercial sale of at least one device or service based on PATENT RIGHTS. 
 LICENSEE will inform HARVARD
promptly in writing about any material problem, delay or requirement in connection with the commercial, development and/or manufacture, use, sale or marketing of LICENSED PRODUCTS. LICENSEE and HARVARD may modify the above performance milestones
accordingly and as mutually agreed. 
  

	 	(e)	 In all sublicenses granted by LICENSEE hereunder, LICENSEE shall include a requirement that the sublicensee use its best efforts to bring the
subject matter of the sublicense into commercial use as quickly as is reasonably possible. LICENSEE shall further provide in such sublicenses that such sublicenses are subject and subordinate to the terms and conditions of this Agreement, except the
sublicensee may not further sublicense. Copies of all sublicense agreements shall be provided promptly to HARVARD. 

  

	 	(f)	 During the period of exclusivity of this license in the United States, LICENSEE shall cause any LICENSED PRODUCT produced for sale in the United
States to be manufactured substantially in the United States. 

  

	4.3	 All rights reserved to the United States Government and others under Public Law 96-517, and Public Law 98-620, shall remain and shall in no way be
affected by this Agreement. 

 ARTICLE V 

ROYALTIES 
  

	5.1	 LICENSEE has paid to HARVARD a non-refundable license royalty fee in the sum of    *** ($***) dollars.

  

	5.2	 (a) Sales/Sublicenses in the Nucleic Acid Sensor Market: LICENSEE shall pay to HARVARD during the term of this Agreement a royalty
of    *** percent (***%) of NET SALES by LICENSEE and sublicensees. In the case of sublicenses that are based solely on PATENT RIGHTS, LICENSEE shall also pay to HARVARD *** (***%) percent of any NON-ROYALTY SUBLICENSE INCOME.
Such additional payments shall only be due for sublicenses executed prior to the four year anniversary of the EFFECTIVE DATE. For any sublicense agreement concluded after the four year anniversary of the EFFECTIVE DATE, and for any sublicense
agreement that is not based solely on PATENT RIGHTS, there shall be no payments due based on NON-ROYALTY SUBLICENSE INCOME; however LICENSEE shall pay to HARVARD a    *** percent (***%) royalty on sublicensee NET SALES.

 (b) Sales/Sublicenses in the Protein Sensor Market: LICENSEE shall pay to
HARVARD during the term of this Agreement a royalty of    *** percent (***%) of NET SALES by LICENSEE and a royalty of    *** percent (***%) of NET SALES by sublicensees. In the case of sublicenses that are
based solely on PATENT RIGHTS or sublicenses which include both the Nucleic Acid Sensor Field and the Protein Sensor Field, LICENSEE shall also pay to HARVARD    *** percent (***%) of any NON-ROYALTY SUBLICENSE INCOME. In the
case of sublicenses that are not based solely on PATENT RIGHTS, LICENSEE shall pay to HARVARD    *** percent (***%) of any NON-ROYALTY SUBLICENSE INCOME. Such additional payments shall only be due for sublicenses executed prior
to the five year anniversary of the EFFECTIVE DATE. For sublicense agreement executed after the five year anniversary of the EFFECTIVE DATE, there will be no payments based on NON-ROYALTY SUBLICENSE INCOME; however LICENSEE shall pay to HARVARD
a    *** percent (***%) royalty on sublicensee NET SALES. 
 (i) If LICENSEE’s
cumulative NET SALES on any one LICENSED PRODUCT reach    *** dollars ($***), LICENSEE may reduce the royalty due to HARVARD under this Section 5.2(b) from NET SALES of such LICENSED PRODUCT by    ***
percent (***%) to a final royalty of    *** percent (***%). 
 (ii) If LICENSEE is required
to obtain license(s)/sublicense(s) for third party patents infringed as a result of practising the subject matter of PATENT RIGHTS, then royalties due HARVARD under this Section 5.2(b) will be reduced by an amount equivalent to the royalty
payable to such third party(s) (“Infringing Royalty”); however, the royalty due HARVARD will not be reduced by more than    *** percent (***%). 

 

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

 (iii) If royalties are paid by LICENSEE to an entity (other than an
AFFILIATE) for LICENSED PRODUCT OR LICENSED PROCESSES for which royalties are also due to HARVARD under this Section 5.2(b) (“Other Royalties”) and total royalties excluding Infringing Royalty for a LICENSED PRODUCT or LICENSED
PROCESS exceed *** percent (***%) of NET SALES, then the royalties due to HARVARD shall be reduced by *** percent (***%) for each percent above *** percent, but only to the extent that the Other Royalties, which are equal to or greater than the
royalty due to HARVARD, are reduced in a like manner. The royalty due HARVARD shall never be reduced by more than *** percent (***%) in any one year. These reductions may not be accumulated and carried over into future years. 

(iv) In no event may the royalty payable to HARVARD under this Section 5.2(b) be reduced below *** percent (***%) as
a result of all the reductions of Sections 5.2(b) (i)-(iii). 
 (c) Only one royalty for each specific sale of a
LICENSED PRODUCT shall be payable irrespective of the number of patents or patent applications in PATENT RIGHTS covering the manufacture, use or sale of such LICENSED PRODUCTS. 

(d) If the license pursuant to this Agreement is converted to a non-exclusive one and if other non-exclusive licenses in
the same field and territory are granted, the above royalties shall not exceed the royalty rate to be paid by other licensees in the same field and territory during the term of the non-exclusive license. 

(e) On sales between LICENSEE and its AFFILIATES or sublicensees for resale, the royalty shall be paid on the NET SALES of
the AFFILIATE or sublicensee. 
  

	5.3	 No later than sixty (60) days from January 1 of each calendar year after the effective date of this Agreement, LICENSEE shall pay to
HARVARD the following non-refundable license maintenance royalty and/or advance on royalties. Such payments may be credited against running royalties due for that calendar year and Royalty Reports shall reflect such a credit. Such payments shall not
be credited against milestone payments (if any) nor against royalties due for any subsequent calendar year. 

  

									
		 	 February 28,1998
	 	$***	  		  	
		 	 February 28,1999
	 	$***	  		  	
		 	 February 28,2000 and each year thereafter
	 	$***	  		  	

  

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

 ARTICLE VI 

REPORTING 
  

	6.1	 Prior to signing this Agreement, LICENSEE has provided to HARVARD a written research and development plan under which LICENSEE intends to bring the
subject matter of the licenses granted hereunder into commercial use upon execution of this Agreement. 

  

	6.2	 No later than February 28 of each calendar year, LICENSEE shall provide to HARVARD a written annual Progress Report describing progress on
research and development, regulatory approvals, manufacturing, sublicensing, marketing and sales during the preceeding calendar year and plans for the forthcoming year. If multiple technologies are covered by the license granted hereunder, the
Progress Report shall provide the information set forth above for each technology. LICENSEE shall also provide any reasonable additional data HARVARD requires to evaluate LICENSEE’s performance. 

 

	6.3	 LICENSEE shall report to HARVARD the date of first sale of LICENSED PRODUCTS (or results of LICENSED PROCESSES) in each country within thirty
(30) days of occurrence. 

  

	6.4	 (a) LICENSEE shall submit to HARVARD on or before February 28 of each calendar year, a Royalty Report setting forth for such preceeding year at
least the following information: 

  

	 	(i)	 the number of LICENSED PRODUCTS sold by LICENSEE, its AFFILIATES and sublicensees in each country; 

 

	 	(ii)	 total billings for such LICENSED PRODUCTS; 

  

	 	(iii)	 an accounting for all LICENSED PROCESSES used or sold; 

 

	 	(iv)	 deductions applicable to determine the NET SALES thereof; 

 

	 	(v)	 the amount of NON-ROYALTY SUBLICENSE INCOME received by LICENSEE; and 

 

	 	(vi)	 the amount of royalty due thereon, or, if no royalties are due to HARVARD for any reporting period, the statement that no royalties are due.

 Such report shall be certified as correct by an officer of LICENSEE and shall include a
detailed listing of all deductions from royalties. 
  

	(b)	 LICENSEE shall pay to HARVARD with each such Royalty Report the amount of royalty due with respect to such year. If multiple technologies are
covered by the license granted hereunder, LICENSEE shall specify which PATENT RIGHTS 

	 	
are utilized for each LICENSED PRODUCT and LICENSED PROCESS included in the Royalty Report. 

  

	(c)	 All payments due hereunder shall be deemed received when funds are credited to Harvard’s bank account and shall be payable by check or wire
transfer in United States dollars. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States (as reported in the New York Times or the Wall Street Journal) on the last working day of each
royalty period. No transfer, exchange, collection or other charges shall be deducted from such payments. 

  

	(d)	 All such reports shall be maintained in confidence by HARVARD except as required by law; however, HARVARD may include in its usual reports annual
amounts of royalties paid. 

  

	(e)	 Late payments shall be subject to a charge of *** percent (***%) per month, or $***, whichever is greater. 

ARTICLE VII 

RECORD KEEPING 
  

	7.1	 LICENSEE shall keep, and shall require its AFFILIATES and sublicensees to keep, accurate records (together with supporting documentation) of
LICENSED PRODUCTS made, used or sold under this Agreement, appropriate to determine the amount of royalties due to HARVARD hereunder. Such records shall be retained for at least three (3) years following the end of the reporting period to which
they relate. They shall be available during normal business hours for examination by an accountant selected by HARVARD, for the sole purpose of verifying reports and payments hereunder. In conducting examinations pursuant to this paragraph,
HARVARD’s accountant shall have access to all records which HARVARD reasonably believes to be relevant to the calculation of royalties under Article IV. 

 

	7.2	 HARVARD’s accountant shall not disclose to HARVARD any information other than information relating to the accuracy of reports and payments made
hereunder. 

  

	7.3	 Such examination by HARVARD’s accountant shall be at HARVARD’S expense, except that if such examination shows an underreporting or
underpayment in excess of five percent (5%) for any twelve (12) month period, then LICENSEE shall pay the cost of such examination as well as any additional sum that would have been payable to HARVARD had the LICENSEE reported correctly,
plus interest on said sum at the rate of one and one half per cent (11/2%) per month. 

  

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

 ARTICLE VIII 

DOMESTIC AND FOREIGN PATENT FILING AND MAINTENANCE 
  

	8.1	 Within sixty (60) days of the execution of this Agreement, LICENSEE shall reimburse HARVARD for all reasonable expenses HARVARD has incurred
for the preparation, filing, prosecution and maintenance of PATENT RIGHTS. Thereafter, LICENSEE shall reimburse HARVARD for all such future expenses upon receipt of invoices from HARVARD. Late payment of these invoices shall be subject to interest
charges of *** percent (***%) per month. HARVARD shall, in its sole discretion, be responsible for the preparation, filing, prosecution and maintenance of any and all patent applications and patents included in PATENT RIGHTS. HARVARD shall consult
with LICENSEE as to the preparation, filing, prosecution and maintenance of such patent applications and patents and shall furnish to LICENSEE copies of documents relevant to any such preparation, filing, prosecution or maintenance.

  

	8.2	 Upon receipt of LICENSEE’s payment of expenses incurred for the preparation, filing, prosecution and maintenance of PATENT RIGHTS according to
8.1, HARVARD shall provide to LICENSEE copies of the complete file history for all patents and patent applications in PATENT RIGHTS. 

  

	8.3	 HARVARD and LICENSEE shall cooperate fully in the preparation, filing, prosecution and maintenance of PATENT RIGHTS and of all patents and patent
applications licensed to LICENSEE hereunder, executing all papers and instruments or requiring members of HARVARD to execute such papers and instruments so as to enable HARVARD to apply for, to prosecute and to maintain patent applications and
patents in HARVARD’s name in any country. Each party shall provide to the other prompt notice as to all matters which come to its attention and which may affect the preparation, filing, prosecution or maintenance of any such patent applications
or patents. 

  

	8.4	 LICENSEE may elect to surrender its PATENT RIGHTS in any country upon sixty (60) days written notice to HARVARD. Such notice shall not relieve
LICENSEE from responsibility to reimburse HARVARD for patent-related expenses incurred prior to the expiration of the (60)-day notice period (or such longer period specified in LICENSEE’S notice). 

ARTICLE IX 

INFRINGEMENT 
  

	9.1	 With respect to any PATENT RIGHTS that are exclusively licensed to LICENSEE pursuant to this Agreement, LICENSEE shall have the right to prosecute
in its own name and at its own expense any infringement in the FIELD 

  

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

	 	
of such patent, so long as such license is exclusive in the FIELD at the time of the commencement of such action. HARVARD agrees to notify LICENSEE promptly of each infringement of such patents
of which HARVARD is or becomes aware. Before LICENSEE commences an action with respect to any infringement of such patents, LICENSEE shall give careful consideration to the views of HARVARD and to potential effects on the public interest in making
its decision whether or not to sue. 

  

	9.2	 (a) If LICENSEE elects to commence an action as described above, Harvard may, to the extent permitted bylaw, elect to join as a party in that
action. Regardless of whether HARVARD elects to join as a party, HARVARD shall cooperate fully with LICENSEE in connection with any such action. 

  

	 	(b)	 If HARVARD elects to join as a party pursuant to subparagraph (a), HARVARD shall jointly control the action with LICENSEE.

  

	 	(c)	 LICENSEE shall reimburse HARVARD for any costs HARVARD incurs, including reasonable attorneys’ fees, as part of an action brought by LICENSEE,
irrespective of whether HARVARD becomes a co-plaintiff. 

  

	9.3	 If LICENSEE elects to commence an action as described above, LICENSEE may deduct from its royalty payments to HARVARD with respect to the patent(s)
subject to suit an amount not exceeding     *** percent (***%) of LICENSEE’s expenses and costs of such action, including reasonable attorneys’ fees; provided, however, that such reduction shall not
exceed    *** percent (***%) of the total royalty due to HARVARD with respect to the patent(s) subject to suit for each calendar year. If such    *** percent (***%) of LICENSEE’s expenses and costs
exceeds the amount of royalties deducted by LICENSEE for any calendar year, LICENSEE may to that extent reduce the royalties due to HARVARD from LICENSEE in succeeding calendar years, but never by more than    *** percent (***%)
of the total royalty due in any one year with respect to the patent(s) subject to suit. 

  

	9.4	 No settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the prior written consent of HARVARD,
which consent shall not be unreasonably withheld. 

  

	9.5	 Recoveries or reimbursements from actions commenced pursuant to this Article shall first be applied to reimburse LICENSEE and HARVARD for litigation
costs not paid from royalties and then to reimburse HARVARD for royalties deducted by LICENSEE pursuant to paragraph 8.3. Any remaining recoveries or reimbursements shall be shared as follows: 

(i) If the amount is lost profits, LICENSEE shall receive an amount equal to the damages the court determines LICENSEE
has suffered as a result of the infringement less the amount of any royalties that would have been due HARVARD on sales of LICENSED PRODUCTS lost by LICENSEE as a result 

 

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

 
of the infringement had LICENSEE made such sales and HARVARD shall receive    ***    have received if such sales had been made by LICENSEE; or 

(ii) As to awards other than lost profits,     *** (*** %) percent to LICENSEE and
    *** (*** %) percent to HARVARD. 
  

	9.6	 If LICENSEE elects not to exercise its right to prosecute an infringement of the PATENT RIGHTS pursuant to this Article, HARVARD may do so at its
own expense, controlling such action and retaining all recoveries therefrom. LICENSEE shall cooperate fully with HARVARD in connection with any such action. Any reasonable legal expenses incurred by LICENSEE as a direct result of such cooperation
shall be reimbursed from HARVARD’s recoveries. 

  

	9.7	 Without limiting the generality of paragraph 9.6, HARVARD may, at its election and by notice to LICENSEE, establish a time limit of sixty
(60) days for LICENSEE to decide whether to prosecute any infringement of which HARVARD is or becomes aware. If, by the end of such sixty (60)-day period, LICENSEE has not commenced such an action, HARVARD may prosecute such an infringement at
its own expense, controlling such action and retaining all recoveries therefrom. With respect to any such infringement action prosecuted by HARVARD in good faith, LICENSEE shall pay over to Harvard any payments (whether or not designated as
“royalties”) made by the alleged infringer to LICENSEE under any existing or future sublicense authorizing LICENSED PRODUCTS, up to the amount of HARVARD’s unreimbursed litigation expenses (including, but not limited to, reasonable
attorneys’ fees). 

  

	9.8	 If a declaratory judgment action is brought naming LICENSEE as a defendant and alleging invalidity of any of the PATENT RIGHTS, HARVARD may elect to
take over the sole defense of the action at its own expense. LICENSEE shall cooperate fully with HARVARD in connection with any such action. 

  

	9.9	 In the event that an action is brought against LICENSEE or any of its sublicensees alleging direct infringement of a patent right due to the
manufacture, use, offer for sale or sale of LICENSED PRODUCTS, LICENSEE may terminate this Agreement upon giving HARVARD written notice of termination. In the event LICENSEE chooses not to terminate this Agreement, LICENSEE and HARVARD shall consult
and decide uon an appropriate course of action regarding defence of the action and payment of royalties. 

  

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

 ARTICLE X 

TERMINATION OF AGREEMENT 
  

	10.1	 This Agreement, unless terminated as provided herein, shall remain in effect until the last patent or patent application in PATENT RIGHTS has
expired or been abandoned. 

  

	10.2	 HARVARD may terminate this Agreement as follows: 

  

	 	(a)	 If LICENSEE does not make a payment due hereunder and fails to cure such non-payment (including the payment of interest in accordance with paragraph
6.4(e)) within forty-five (45) days after the date of notice in writing of such non-payment by HARVARD. 

  

	 	(b)	 If LICENSEE defaults in its obligations under paragraph 11.3(c)and(d) to procure and maintain insurance. 

 

	 	(c)	 If, at any time after five years from the date of this Agreement, HARVARD determines that the Agreement should be terminated pursuant to paragraph
4.2(d). 

  

	 	(d)	 If LICENSEE shall become insolvent, shall make an assignment for the benefit of creditors, or shall have a petition in bankruptcy filed for or
against it. Such termination shall be effective immediately upon HARVARD giving written to LICENSEE. 

  

	 	(e)	 If an examination by Harvard’s accountant pursuant to Article VII shows a repeated pattern of fraudulent underreporting or underpayment by
LICENSEE in excess of 20% for any twelve (12) month period. 

  

	 	(f)	 If LICENSEE is convicted of a felony and has exhausted its appeals to such conviction relating to the manufacture, use, or sale of LICENSED
PRODUCTS. 

  

	 	(g)	 Except as provided in subparagraphs (a), (b), (c), (d), (e) and (f) above, if LICENSEE defaults in the performance of any obligations
under this Agreement and the default has not been remedied within ninety (90) days after the date of notice in writing of such default by HARVARD. 

 

	10.3	 LICENSEE shall provide, in all sublicenses granted by it under this Agreement, that LICENSEE’s interest in such sublicenses shall at
HARVARD’s option terminate or be assigned to HARVARD upon termination of this Agreement. 

  

	10.4	 LICENSEE may terminate this Agreement by giving ninety (90) days advance written notice of termination to HARVARD. Upon termination, LICENSEE
shall 

	 	
submit a final Royalty Report to HARVARD and any royalty payments and unreimbursed patent expenses invoiced by HARVARD shall become immediately payable. 

 

	10.5	 Paragraphs 7.1, 7.2, 7.3, 8.1, 9.5, 10.4, 10.5, 11.2, 11.3, 11.4, 11.5, 11.8 and 11.9 of this Agreement shall survive termination.

 ARTICLE XI 

GENERAL 
  

	11.1	 HARVARD does not warrant the validity of the PATENT RIGHTS licensed hereunder and makes no representations whatsoever with regard to the scope of
the licensed PATENT RIGHTS or that such PATENT RIGHTS may be exploited by LICENSEE, an AFFILIATE, or sublicensee without infringing other patents. 

  

	11.2	 HARVARD EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED OR EXPRESS WARRANTIES AND MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR
ANY PARTICULAR PURPOSE OF THE PATENT RIGHTS, OR INFORMATION SUPPLIED BY HARVARD, LICENSED PROCESSES OR LICENSED PRODUCTS CONTEMPLATED BY THIS AGREEMENT. 

 

	11.3	 (a) LICENSEE shall indemnify, defend and hold harmless HARVARD and its current or former directors, governing board members, trustees, officers,
faculty, medical and professional staff, employees, students, and agents and their respective successors, heirs and assigns (collectively, the “Indemnitees”), against any liability, damage, loss or expenses (including reasonable
attorneys’ fees and expenses of litigation) incurred by or imposed upon the Indemnitees or any of them in connection with any claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not
limited to, actions in the form of tort, warranty, or strict liability) concerning any product, process or service made, used or sold pursuant to any right or license granted under this Agreement. 

 

	(b)	 LICENSEE shall, at its own expense, provide attorneys reasonably acceptable to HARVARD to defend against any actions brought or filed against any
Indemnitee hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought. 

  

	(c)	 Beginning at the time any such product, process or service is being commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by LICENSEE or by a sublicensee, AFFILIATE or agent of LICENSEE, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $*** per incident and $***
annual aggregate and naming the Indemnitees as additional insureds. During clinical 

  

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

	 	
trials of any such product, process or service, LICENSEE shall, at its sole cost and expense, procure and maintain commercial general liability insurance in such equal or lesser amount as HARVARD
shall require, naming the Indemnitees as additional insureds. Such commercial general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage for LICENSEE’S indemnification
under this Agreement. If LICENSEE elects to self-insure all or part of the limits described above (including deductibles or retentions which are in excess of $*** annual aggregate) such self-insurance program must be acceptable to HARVARD and the
Risk Management Foundation of the Harvard Medical Institutions, Inc. in their sole discretion. The minimum amounts of insurance coverage required shall not be construed to create a limit of LICENSEE’s liability with respect to its
indemnification under this Agreement. 

  

	(d)	 LICENSEE shall provide HARVARD with written evidence of such insurance upon request of HARVARD. LICENSEE shall provide HARVARD with written notice
at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance; if LICENSEE does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, HARVARD shall have
the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods. 

  

	(e)	 LICENSEE shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the
period that any product, process, or service, relating to, or developed pursuant to, this Agreement is being commercially distributed or sold by LICENSEE or by a sublicensee, AFFILIATE or agent of LICENSEE and (ii) a reasonable period after the
period referred to in (e)(i) above which in no event shall be less than fifteen (15) years. 

  

	11.4	 LICENSEE shall not use HARVARD’s name or insignia, or any adaptation of them, or the name of any of HARVARD’s inventors in any
advertising, promotional or sales literature without the prior written approval of HARVARD. 

  

	11.5	 HARVARD shall not use LICENSEE’s name or logos in any advertising or promotional literature without the prior written approval of LICENSEE, nor
may HARVARD disclose the financial terms of this Agreement without LICENSEE’s prior written approval, except as required by law. HARVARD may use LICENSEE’s name and royalty information in its own internal confidential reports.

  

	11.6	 Without the prior written approval of HARVARD in each instance, neither this Agreement nor the rights granted hereunder shall be transferred or
assigned in whole or in part by LICENSEE to any person whether voluntarily or involuntarily, by operation of law or otherwise. This Agreement shall be binding upon the respective successors, legal representatives and assignees of HARVARD and
LICENSEE. 

  

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

	11.7	 The interpretation and application of the provisions of this Agreement shall be governed by the laws of the Commonwealth of Massachusetts.

  

	11.8	 LICENSEE shall comply with all applicable laws and regulations. In particular, it is understood and acknowledged that the transfer of certain
commodities and technical data is subject to United States laws and regulations controlling the export of such commodities and technical data, including all Export Administration Regulations of the United States Department of Commerce. These laws
and regulations among other things, prohibit or require a license for the export of certain types of technical data to certain specified countries. LICENSEE hereby agrees and gives written assurance that it will comply with all United States laws
and regulations controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by LICENSEE or its AFFILIATES or sublicensees, and that it will defend and hold HARVARD harmless in the event of
any legal action of any nature occasioned by such violation. 

  

	11.9	 LICENSEE agrees (i) to obtain all regulatory approvals required for the manufacture and sale of LICENSED PRODUCTS and LICENSED PROCESSES and
(ii) to utilize appropriate patent marking on such LICENSED PRODUCTS. LICENSEE also agrees to register or record this Agreement as is required by law or regulation in any country where the license is in effect. 

 

	11.10	 Any notices to be given hereunder shall be sufficient if signed by the party (or party’s attorney) giving same and either (a) delivered in
person, or (b) mailed certified mail return receipt requested, or (c) faxed to other party if the sender has evidence of successful transmission and if the sender promptly sends the original by ordinary mail, in any event to the following
addresses: 

 If to LICENSEE: 

Jon Faiz Kayyem, PhD 

President and CEO 

Clinical Micro Sensors, Inc 

101 Waverly Drive 

Pasadena, CA 91105 

Fax: 818-584-5900 

If to Harvard to: 

Office for Technology and 

Trademark Licensing 

Harvard University 

124 Mt. Auburn Street, Suite 410 South 

Cambridge, MA 02138 

Fax No.: 617-495-9568 

By such notice either party may change their address for future notices. 

 Notices delivered in person shall be deemed given on the date delivered.
Notices sent by fax shall be deemed given on the date faxed. Notices mailed shall be deemed given on the date postmarked on the envelope. 
  

	11.11	 Should a court of competent jurisdiction later hold any provision of this Agreement to be invalid, illegal, or unenforceable, and such holding is
not reversed on appeal, it shall be considered severed from this Agreement. All other provisions, rights and obligations shall continue without regard to the severed provision, provided that the remaining provisions of this Agreement are in
accordance with the intention of the parties. 

  

	11.12	 This Agreement constitutes the entire understanding between the parties and neither party shall be obligated by any condition or representation
other than those expressly stated herein or as may be subsequently agreed to by the parties hereto in writing. 

 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their
duly authorized representatives. 
  

					
	 PRESIDENT AND FELLOWS OF

HARVARD COLLEGE
	 		 	LICENSEE
			
	 /s/ Joyce Brinton
	 		 	 /s/ Jon Faiz Kayyem

	 Joyce Brinton, Director

Office for Technology and Trademark Licensing
	 		 	Signature
			
		 		 	 Jon Faiz Kayyem, Ph.D.

		 		 	Name
			
		 		 	 President & CEO

		 		 	Title
			
	 1/7/98
	 		 	 January 13, 1998

	Date	 		 	Date

 Appendix A 

The following comprise PATENT RIGHTS: 

US patent application serial no. 08/312,388, filed 9/26/94, entitled “Molecular Recognition at Surfaces Derivatized with Self
Assembled Monolayers” 
 Continuation-in-part of USSN 08/312,388 filed 1/21/97, serial no. 08/786,187 

US patent application entitled “Immobilized Nucleic Acid and Electron Transfer Devices or Methods”, filed 1/21/97, serial no.
08/786,153 (abd) 
 Continuation-in-part of US patent application filed 1/21/97 entitled “Immobilized Nucleic Acid and
Electron Transfer Devices or Methods”, such CIP was filed on 2/24/97 and is entitled “Electronic-Property Probing of Biological Molecules at Surfaces”, serial no. 08/804,883 (abd) 

Continuation-in-part of US patent application filed 1/21/97 entitled “Immobilized Nucleic Acid and Electron Transfer Devices or
Methods”, such CIP was filed on 4/10/97 and is entitled “Electronic-Property Probing of Biological Molecules at Surfaces”, serial no. 08/843,623License Agmt - Marshfield Clinic

 EXHIBIT 10.9 

Agreement No. 07-M0001 

This draft is dated October 18, 2007, and is solely for purposes of negotiation. No contract shall exist until a
final, written agreement is signed by MARSHFIELD CLINIC and an authorized representative of Licensee. This draft shall expire on November 10, 2007. 

EXCLUSIVE LICENSE AGREEMENT 

This Agreement is made effective the
15th day of October, 2007, by and between Marshfield
Clinic (hereinafter called “MARSHFIELD CLINIC”), a nonstock, nonprofit Wisconsin corporation, and Osmetech Molecular Diagnostics (hereinafter called “Licensee”), a corporation organized and existing under the laws of Delaware;

 WHEREAS, MARSHFIELD CLINIC owns certain intellectual property rights to the inventions described in
the “Licensed Patents” defined below, and MARSHFIELD CLINIC is willing to grant a license to Licensee under any one or all of the Licensed Patents and Licensee desires a license under all of them; 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the parties covenant and
agree as follows: 
 Section 1: Definitions. 

For the purpose of this Agreement, the Appendix A definitions shall apply. 

Section 2: Grant. 

A. License and Option. 

(i) MARSHFIELD CLINIC hereby grants to Licensee under the Licensed Patents an exclusive license to make, use and sell
Products in the Licensed Field and Licensed Territory. 
 (ii) MARSHFIELD CLINIC grants to Licensee an
exclusive option to license any warfarin molecular markers identified by inventors of MARSHFIELD CLINIC and solely owned by MARSHFIELD CLINIC that are identified before January 1, 2011. MARSHFIELD CLINIC also grants a non-exclusive option to
non-exclusively license warfarin molecular markers jointly owned by MARSHFIELD CLINIC, provided MARSHFIELD CLINIC is not restricted from doing so by agreement with joint owner. Such offer is conditional on Licensee’s satisfactory progress
towards market launch of Licensed Products, including receiving FDA approval (Appendix E), as determined by MARSHFIELD CLINIC. MARSHFIELD CLINIC shall notify Licensee in writing of any such markers in a timely manner, after such markers are
disclosed by the inventors to MARSHFIELD CLINIC. Upon receipt of notification, Licensee shall have thirty (30) days to provide written notice to MARSHFIELD CLINIC that Licensee desires to exercise such option. Upon MARSHFIELD CLINIC’S
receipt of such notice, MARSHFIELD CLINIC and Licensee shall enter into good faith negotiations regarding the terms of a license agreement and shall have ninety (90) days from the date of notice to negotiate such a license. If MARSHFIELD CLINIC
and Licensee fail to enter a license within such time period, the option granted shall terminate, unless extended by a written agreement signed by both parties, but only with respect to the specific warfarin molecular marker disclosed. 

(iii) In consideration of establishing a long-term collaboration, Licensee agrees to place an Osmetech eSensor XT-8
instrument at MARSHFIELD CLINIC and provide necessary training on or before March 31, 2008. The Licensee retains all rights to the equipment and may terminate the arrangement after a six (6) month advance notice. 

 

					
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 B. Sublicenses. 

(i) Licensee may grant written, nonexclusive sublicenses to third parties. Any agreement granting a sublicense shall
state that the sublicense is subject to the termination of this Agreement. Licensee shall have the same responsibility for the activities of any sublicensee as if the activities were directly those of Licensee. Licensee shall provide MARSHFIELD
CLINIC with the name, contact information and address of each sublicensee, as well as information regarding the number of full-time employees of any such sublicensee to allow MARSHFIELD CLINIC to determine whether it can maintain its small entity
filing status for patent prosecution and maintenance purposes. 
 (ii) With respect to sublicenses granted by
Licensee under this Section 2B, Licensee shall pay to MARSHFIELD CLINIC an amount equal to what Licensee would have been required to pay to MARSHFIELD CLINIC had Licensee sold the amount of Products sold by such sublicensee. In addition,
Licensee shall pay to MARSHFIELD CLINIC    *** percent (***%) of all upfronts, milestone payments, penalties, or other payments in consideration of the sublicense, exclusive of royalties owed. Licensee shall not receive from its
sublicensees anything of value in lieu of cash payments in consideration for any sublicense granted under this Agreement without the express prior written consent of MARSHFIELD CLINIC. 

C. Reservation of Rights. 

MARSHFIELD CLINIC hereby reserves the right to grant non-profit research institutions and governmental agencies
non-exclusive licenses to practice and use the inventions of the Licensed Patents for Non-Commercial Research Purposes. Marshfield Clinic and the inventors of the Licensed Patents shall have the right to publish any information included in the
Licensed Patents. 
 D. License to MARSHFIELD CLINIC. 

(i) Licensee hereby grants, and shall require its sublicensee(s) to grant, to MARSHFIELD CLINIC a nonexclusive,
royalty-free, irrevocable, paid-up license, with the right to grant sublicenses to non-profit research institutions and governmental agencies, to practice and use of the Licensed Patents and “Improvements” for Non-Commercial Research
Purposes. “Improvements” shall mean any patented modification of an invention described in the Licensed Patents that (1) would be infringed by the practice of an invention claimed in the Licensed Patents; or (2) if not for the
license granted under this Agreement, would infringe one or more claims of the Licensed Patents. Licensee shall provide MARSHFIELD CLINIC with a written, enabling disclosure of each such invention, unambiguously identifying it as an invention
governed by this paragraph, within six (6) months of the issuance of a patent thereon. 
 (ii) In the
event that Licensee and its sublicensee(s) discontinue the use or commercialization of the Licensed Patents or any Improvements provided for under this Agreement, Licensee shall grant, and shall require its sublicensee(s) to grant, to MARSHFIELD
CLINIC an option to obtain a nonexclusive, royalty-bearing license, with the right to grant sublicenses, to practice and use said Improvements for commercial purposes. Licensee shall provide to MARSHFIELD CLINIC written notice that Licensee and its
sublicensee(s) intend to discontinue such use or commercialization immediately upon making such a decision. Marshfield Clinic’s option with respect to each Improvement shall expire sixty (60) days after Marshfield Clinic’s receipt of
said written notice from Licensee. The failure of MARSHFIELD CLINIC to timely exercise its option under this paragraph shall be deemed a waiver of Marshfield Clinic’s option, but only with respect to the Improvement so disclosed. 

 

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 Section 3: Development. 

A. Licensee shall diligently develop, manufacture, market and sell Products in each Licensed Field and Licensed Territory
throughout the term of this Agreement. Such activities shall include, without limitation, those activities listed in the Development Plan attached hereto as Appendix E. Licensee agrees that said Development Plan is reasonable and that it shall
take all reasonable steps to meet the development program as set forth therein. 
 B. Beginning in calendar
year 2008 and until the Date of First Commercial Sale, Licensee shall provide MARSHFIELD CLINIC with a written Development Report summarizing Licensee’s development activities since the last Development Report and any necessary adjustments to
the Development Plan. Licensee agrees to provide each Development Report to MARSHFIELD CLINIC on or before thirty (30) days from the end of each semi-annual period ending June 30 and December 31 for which a report is due, and shall
set forth in each Development Report sufficient detail to enable MARSHFIELD CLINIC to ascertain Licensee’s progress toward the requirements of the Development Plan. MARSHFIELD CLINIC reserves the right to audit Licensee’s records relating
to the development activities required hereunder. Such record keeping and audit procedures shall be subject to the procedures and restrictions set forth in Section 6 for auditing the financial records of Licensee. 

C. Licensee agrees to and warrants that it has, or will obtain, the expertise necessary to independently evaluate the
inventions of the Licensed Patents and to develop Products for sale in the commercial market and that it so intends to develop Products for the commercial market. Licensee acknowledges that any failure by Licensee to reasonably implement the
Development Plan, or to make timely submission to MARSHFIELD CLINIC of any Development Report, or the providing of any false information to MARSHFIELD CLINIC regarding Licensee’s development activities hereunder, shall be a material breach of
this Agreement. 
 Section 4: Consideration. 

 

	 	A.	 License Fee. 

License agrees to pay MARSHFIELD CLINIC a    ***     of $*** US within thirty
(30) days of Licensee’s execution of this Agreement. 
  

	 	B.	 Royalty. 

In addition to the Section 4A license fee, Licensee agrees to pay to MARSHFIELD CLINIC as “earned
royalties” a royalty calculated as a percentage of the Selling Price of Products in accordance with the terms and conditions of this Agreement. The royalty is deemed earned as of the earlier of the date the Product is actually sold, leased or
otherwise transferred for consideration, the date an invoice is sent by Licensee, or the date a Product is transferred to a third party for any promotional reasons. The royalty shall remain fixed while this Agreement is in effect at a rate
of     *** percent (***%) of the Selling Price of Products. 
  

	 	C.	 Minimum Royalty. 

Licensee further agrees to pay to MARSHFIELD CLINIC a minimum royalty of $***    per calendar year or
part thereof during which this Agreement is in effect starting in calendar year 2009, against which any earned royalty paid for the same calendar year will be credited provided that MARSHFIELD CLINIC proves clinical utility for its SNP rs2108622 in
the gene CYP4F2 through 
  

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clinical validation studies. Such validation studies are being conducted at MARSHFIELD CLINIC now in partnership with external collaborators. Positive results of such studies will be considered
as proof of clinical validation. Unless and until Marshfield Clinic secures such validation, no obligation will exist for Licensee to pay such minimum royalty. The minimum royalty for a given year shall be due at the time payments are due for the
calendar quarter ending on December 31. It is understood that the minimum royalties will apply on a calendar year basis, and that sales of Products requiring the payment of earned royalties made during a prior or subsequent calendar year shall
have no effect on the annual minimum royalty due MARSHFIELD CLINIC for any other given calendar year. 
 D.
Patent Fees and Costs. 
 MARSHFIELD CLINIC has authorized WiSys Technology Foundation to file, prosecute
and maintain patent coverage of the Licensed Patent or patent application on its behalf. Therefore, WiSys Technology Foundation shall be the contact agency for Licensee regarding all matters described in this Section 4D. 

(i) Licensee also agrees to reimburse MARSHFIELD CLINIC for one hundred percent (100%) of all reasonable costs incurred
by MARSHFIELD CLINIC in filing, prosecuting and maintaining the Licensed Patents in US, EU and Japan. All such costs for each Licensed Patent shall come due only after the applicable patent office has issued a notification of allowance (or its
equivalent), and shall be paid by Licensee within thirty (30) days of receipt of an invoice from MARSHFIELD CLINIC, or WiSys Technology Foundation, acting on behalf of MARSHFIELD CLINIC. 

(ii) MARSHFIELD CLINIC is not obligated to make or maintain any foreign filing of the Licensed Patents other than
agreeing that it shall make and maintain US, EU (7 selected countries in Europe) and Japan filings of the Licensed Patents. If Licensee desires MARSHFIELD CLINIC to make or maintain other foreign filings, Licensee must notify MARSHFIELD CLINIC
in writing three (3) months prior to the expiration of the deadline for making such foreign filings, indicating those countries in which Licensee desires MARSHFIELD CLINIC to pursue foreign patent protection. Licensee agrees to pay all
reasonable patenting costs for additional countries within thirty (30) days of receiving an invoice from MARSHFIELD CLINIC. Any country for which MARSHFIELD CLINIC files for such patent protection at Licensee’s request shall be included in
the Licensed Territory under this Agreement. MARSHFIELD CLINIC reserves the right to file a patent application, at its own expense, in any countries not requested by Licensee pursuant to this Section 4D. Licensee acknowledges that if the United
States Government (through any of its agencies or otherwise) has funded research, during the course of or under which any of the inventions of the Licensed Patents were conceived or made, the United States Government is entitled, as a right, under
the provisions of 35 U.S.C. § 200-212 and applicable regulations of Chapter 37 of the Code of Federal Regulations, to make and maintain foreign filings in those countries not selected by Licensee and/or MARSHFIELD CLINIC. 

 
  

					
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 (iii) MARSHFIELD CLINIC will prosecute all national applications it files
at Licensee’s request pursuant to this Section 4D until MARSHFIELD CLINIC determines that continued prosecution is unlikely to result in the issuance of a patent in that country. If MARSHFIELD CLINIC decides to abandon prosecution or
maintenance of any patent or patent application under the Licensed Patents in a country in which Licensee has requested MARSHFIELD CLINIC to make and maintain such filing, MARSHFIELD CLINIC shall provide Licensee notice of Marshfield Clinic’s
intent to abandon such application. In such event, Licensee shall have the right to continue prosecution of said application, at its own expense, on behalf of MARSHFIELD CLINIC and Licensee, to the extent allowed under applicable law. 

E. Accounting; Payments. 

(i) Amounts owing to MARSHFIELD CLINIC under Sections 2B and 4B shall be paid on a quarterly
basis, with such amounts due and received by MARSHFIELD CLINIC on or before the thirtieth
(30th) day following the end of the calendar quarter
ending on March 31, June 30, September 30 or December 31 in which such amounts were earned. The balance of any amounts which remain unpaid more than thirty (30) days after they are due to MARSHFIELD CLINIC shall accrue
interest until paid at the rate of the lesser of    *** percent (***%) per month or the maximum amount allowed under applicable law. However, in no event shall this interest provision be construed as a grant of permission for any
payment delays. 
 (ii) Except as otherwise directed, all amounts owing to MARSHFIELD CLINIC under this
Agreement shall be paid in U.S. dollars to MARSHFIELD CLINIC at the address provided in Section 16(a). All royalties owing with respect to Selling Prices stated in currencies other than U.S. dollars shall be converted at the rate shown in the
Federal Reserve Noon Valuation - Value of Foreign Currencies on the day preceding the payment. MARSHFIELD CLINIC is exempt from paying income taxes under U.S. law. Therefore, all payments due under this Agreement shall be made without deduction for
taxes, assessments, or other charges of any kind which may be imposed on MARSHFIELD CLINIC by any government outside of the United States or any political subdivision of such government with respect to any amounts payable to MARSHFIELD CLINIC
pursuant to this Agreement. All such taxes, assessments, or other charges shall be assumed by Licensee. 

(iii) A full accounting showing how any amounts owing to MARSHFIELD CLINIC under Sections 2B and 4B have been
calculated shall be submitted to MARSHFIELD CLINIC on the date of each such payment. Such accounting shall be on a per-country and product line, model or trade name basis and shall be summarized on the form shown in Appendix C of this
Agreement. In the event no payment is owed to MARSHFIELD CLINIC, a statement setting forth that fact shall be supplied to MARSHFIELD CLINIC. 

Section 5: Certain Warranties. 

A. MARSHFIELD CLINIC warrants that except as otherwise provided under Section 14 of this Agreement with respect to
U.S. Government interests, it is the owner of the Licensed Patents or otherwise has the right to grant the licenses granted to Licensee in this Agreement. However, nothing in this Agreement shall be construed as: 

(i) a warranty or representation by MARSHFIELD CLINIC as to the validity or scope of any of the Licensed Patents;

  

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 (ii) a warranty or representation that anything made, used, sold or
otherwise disposed of under the license granted in this Agreement will or will not infringe patents of third parties; or 

(iii) an obligation to furnish any know-how not provided in the Licensed Patents or any services other than those
specified in this Agreement. 
 B. MARSHFIELD CLINIC MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH RESPECT TO THE USE, SALE, OR OTHER DISPOSITION BY LICENSEE, ITS SUBLICENSEE(S), OR THEIR VENDEES OR OTHER TRANSFEREES, OF PRODUCTS INCORPORATING OR MADE BY USE OF
INVENTIONS LICENSED UNDER THIS AGREEMENT. 
 C. Licensee represents and warrants that Products produced under
the license granted herein shall be manufactured substantially in the United States as required by 35 U.S.C. § 204 and applicable regulations of Chapter 37 of the Code of Federal Regulations. 

Section 6: Recordkeeping. 

A. Licensee and its sublicensee(s) shall keep books and records sufficient to verify the accuracy and completeness of
Licensee’s and its sublicensee(s)’s accounting referred to above, including, without limitation, inventory, purchase and invoice records relating to the Products or their manufacture. In addition, Licensee shall maintain documentation
evidencing that Licensee is in fact pursuing the development of Products as required herein. Such documentation may include, but is not limited to, invoices for studies advancing the development of Products, laboratory notebooks, internal job cost
records, and filings made to the Internal Revenue Department to obtain tax credit, if available, for research and development of Products. Such books and records shall be preserved for a period not less than six (6) years after they are created
during and after the term of this Agreement. 
 B. Licensee and its sublicensee(s) shall take all steps
necessary so that MARSHFIELD CLINIC may within thirty (30) days of its request review and copy all the books and records at a single U.S. location to allow MARSHFIELD CLINIC to verify the accuracy of Licensee’s royalty reports and
Development Reports and the royalty reports of its sublicensee(s). Such review may be performed by any employee of MARSHFIELD CLINIC as well as by any attorney or registered CPA designated by MARSHFIELD CLINIC, upon reasonable notice and during
regular business hours. 
 C. If a royalty payment deficiency is determined, Licensee and its sublicensee(s), as
applicable, shall pay the royalty deficiency outstanding within thirty (30) days of receiving written notice thereof, plus interest on outstanding amounts as described in Section 4E(i). 

D. If a royalty payment deficiency for a calendar year exceeds the lesser of    *** percent (***%) of
the royalties paid for that year or $***    then Licensee or its sublicensee(s) shall be responsible for paying Marshfield Clinic’s out-of-pocket expenses incurred with respect to such review. 

Section 7: Term and Termination. 

A. The term of this license shall begin on the effective date of this Agreement and continue until this Agreement is
terminated as provided herein or until the earlier of the date that no 
  

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Licensed Patent remains an enforceable patent or the payment of earned royalties under Sections 2B and 4B, once begun, ceases for more than eight (8) calendar quarters. 

B. Licensee may terminate this Agreement at any time by giving at least ninety (90) days written and unambiguous
notice of such termination to MARSHFIELD CLINIC. Such a notice shall be accompanied by a statement of the reasons for termination. 

C. MARSHFIELD CLINIC shall have the right to terminate this Agreement if Licensee fails to offer for sale to the retail
market a diagnostic Product (APPENDIX A) by January 1, 2011 by giving Licensee at least ninety (90) days written notice. 

D. If Licensee at any time defaults in the timely payment of any monies due to MARSHFIELD CLINIC or the timely submission
to MARSHFIELD CLINIC of any Development Report, fails to actively pursue the development plan, or commits any breach of any other covenant herein contained, and Licensee fails to remedy any such breach or default within ninety (90) days after
written notice thereof by MARSHFIELD CLINIC, or if Licensee commits any act of bankruptcy, becomes insolvent, is unable to pay its debts as they become due, files a petition under any bankruptcy or insolvency act, or has any such petition filed
against it which is not dismissed within sixty (60) days, or if Licensee or its sublicensee(s) offer any component of the Licensed Patents to their creditors, MARSHFIELD CLINIC may, at its option, terminate this Agreement by giving notice of
termination to Licensee. 
 E. Upon the termination of this Agreement, Licensee and its sublicensee(s) shall
remain obligated to provide an accounting for and to pay royalties earned up to the date of the termination, and any minimum royalties shall be prorated as of the date of termination by the number of days elapsed in the applicable calendar year.

 F. Waiver by either party of a single breach or default, or a succession of breaches or defaults, shall not
deprive such party of any right to terminate this Agreement in the event of any subsequent breach or default. 

Section 8: Assignability. 

This Agreement may not be transferred or assigned by Licensee without the prior written consent of MARSHFIELD CLINIC,
except upon the sale of substantially all of the Licensee’s assets, in which case no consent for such assignment is required. 

Section 9: Contest of Validity. 

In the event Licensee or its sublicensee(s) contest the validity or enforceability of any Licensed Patent, Licensee and
its sublicensee(s) shall continue to pay royalties with respect to that patent as if such contest were not underway until the patent is adjudicated invalid or unenforceable by a court of last resort. 

Section 10: Enforcement. 

MARSHFIELD CLINIC intends to protect the Licensed Patents against infringers or otherwise act to eliminate infringement
when, in Marshfield Clinic’s sole judgment, such action may be necessary, proper, justified and makes reasonable business sense considering all factors. In the event that Licensee or its sublicensee(s) believe there is infringement of any
Licensed Patent under this Agreement which is to its substantial detriment, Licensee shall provide MARSHFIELD CLINIC with notification and reasonable evidence of such infringement. 

 

					
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 Section 11: Patent Marking. 

Licensee and its sublicensee(s) shall mark all Products or Product packaging with the appropriate patent number reference
in compliance with the requirements of U.S. law, 35 U.S.C. § 287. 
 Section 12: Product Liability;
Conduct of Business. 
 A. Licensee shall, at all times during the term of this Agreement and thereafter,
indemnify, defend and hold MARSHFIELD CLINIC and the inventors of the Licensed Patents harmless against all claims and expenses, including legal expenses and reasonable attorneys fees, arising out of the death of or injury to any person or persons
or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever resulting from the production, manufacture, sale, use, lease, consumption or advertisement of Products arising from any
right or obligation of Licensee or its sublicensee(s) hereunder. MARSHFIELD CLINIC at all times reserves the right to select and retain counsel of its own to defend Marshfield Clinic’s interests. 

B. Licensee warrants that it now maintains and will continue to maintain liability insurance coverage appropriate to the
risk involved in marketing the products subject to this Agreement and that such insurance coverage lists MARSHFIELD CLINIC and the inventors of the Licensed Patents as additional insureds. Within ninety (90) days after the execution of this
Agreement and thereafter annually between January 1 and January 31 of each year, Licensee will present evidence to MARSHFIELD CLINIC that the coverage is being maintained with MARSHFIELD CLINIC and its inventors listed as additional
insureds. In addition, Licensee shall provide MARSHFIELD CLINIC with at least thirty (30) days prior written notice of any change in or cancellation of the insurance coverage. 

Section 13: Use of Names. 

Neither Licensee nor its sublicensee(s) shall use Marshfield Clinic’s name, the name of any inventor of inventions
governed by this Agreement, in sales promotion, advertising, or any other form of publicity without the prior written approval of the entity or person whose name is being used; except that one or more press releases evidencing the existence of this
Agreement may be undertaken by the parties, said releases to be jointly-approved between them prior to release. 

Section 14: United States Government Interests. 

It is understood that if the United States Government (through any of its agencies or otherwise) has funded research,
during the course of or under which any of the inventions of the Licensed Patents were conceived or made, the United States Government is entitled, as a right, under the provisions of 35 U.S.C. §§ 200-212 and applicable regulations of
Chapter 37 of the Code of Federal Regulations, to a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced the invention of such Licensed Patents for governmental purposes. Any license granted under this
Agreement to Licensee or any of its sublicensee shall be subject to such right. 
 Section 15:
Miscellaneous. 
 This Agreement shall be governed by and construed in all respects in accordance with the
laws of the State of Wisconsin. If any provisions of this Agreement are or shall come into conflict with the laws or regulations of any jurisdiction or any governmental entity having jurisdiction over the parties or this Agreement, those provisions
shall be deemed automatically deleted, if such deletion is allowed by relevant law, and the remaining terms and conditions of this Agreement shall remain in full force and effect. If such a deletion is not so allowed or if such a deletion leaves
terms thereby made clearly illogical 
  

					
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or inappropriate in effect, the parties agree to substitute new terms as similar in effect to the present terms of this Agreement as may be allowed under the applicable laws and regulations. The
parties hereto are independent contractors and not joint venturers or partners. 
 Section 16: Notices.

 Any notice required to be given pursuant to the provisions of this Agreement shall be in writing and shall be
deemed to have been given at the earlier of the time when actually received as a consequence of any effective method of delivery, including but not limited to hand delivery, transmission by telecopier, or delivery by a professional courier service
or the time when sent by certified or registered mail addressed to the party for whom intended at the address below or at such changed address as the party shall have specified by written notice, provided that any notice of change of address shall
be effective only upon actual receipt. 
  

			
	 (a)
	  	 WiSys Technology Foundation

		  	 Attn: Contracts Manager

		  	 614 Walnut Street

		  	 Madison, Wisconsin 53726

		
	(b)	  	Licensee Osmetech Molecular Diagnostics Inc.
		  	Attn: Legal Department
		  	757 S. Raymond Ave
		  	Pasadena, CA 91105

 Section
17: Integration. 
 This Agreement constitutes the full understanding between the parties with reference
to the subject matter hereof, and no statements or agreements by or between the parties, whether orally or in writing, except as provided for elsewhere in this Section 17, made prior to or at the signing hereof, shall vary or modify the written
terms of this Agreement. Neither party shall claim any amendment, modification, or release from any provisions of this Agreement by mutual agreement, acknowledgment, or otherwise, unless such mutual agreement is in writing, signed by the other
party, and specifically states that it is an amendment to this Agreement. 
 Section 18: Confidentiality.

 The parties hereto agree to keep any information identified as confidential by the disclosing party
confidential using methods at least as stringent as each party uses to protect its own confidential information. “Confidential Information” shall include Licensee’s development plan and development reports, the Licensed Patents and
all information concerning them and any other information marked confidential or accompanied by correspondence indicating such information is exchanged in confidence between the parties. Except as may be authorized in advance in writing by
MARSHFIELD CLINIC, Licensee shall only grant access to Marshfield Clinic’s Confidential Information to its sublicensee(s) and those employees of Licensee and its sublicensee(s) involved in research relating to the Licensed Patents. Licensee
shall require its sublicensee(s) and all such employees to be bound by terms of confidentiality no less restrictive than those set forth in this Section 18. Licensee and its sublicensee(s) shall not use any Confidential Information to
Marshfield Clinic’s detriment, including, but not limited to, claiming priority to the Licensed Patents in any patent prosecution. The confidentiality and use obligations set forth above apply to all or any part of the Confidential Information
disclosed hereunder except to the extent that: 
  

					
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 (i) MARSHFIELD CLINIC, Licensee or its sublicensee(s) can show by written
record that it possessed the information prior to its receipt from the other party; 
 (ii) the information was
already available to the public or became so through no fault of MARSHFIELD CLINIC, Licensee or its sublicensee(s); 

(iii) the information is subsequently disclosed to MARSHFIELD CLINIC, Licensee or its sublicensee(s) by a third party
that has the right to disclose it free of any obligations of confidentiality; or 
 (iv) five (5) years
have elapsed from the expiration of this Agreement. 
 Section 19: Authority. 

The persons signing on behalf of MARSHFIELD CLINIC and Licensee hereby warrant and represent that they have authority to
execute this Agreement on behalf of the party for whom they have signed. 
 IN WITNESS WHEREOF, the parties
hereto have duly executed this Agreement on the dates indicated below. 
  

					
	 MARSHFIELD CLINIC

			
	 By:
	 	 /s/ Robert A. Carlson
	 	 Date: Oct 20, 2007

  

							
	Name and Office:	 	 /s/ Robert A. Carlson, MD – Director

Applied Sciences
	 	

  

					
	 OSMETECH MOLECULAR DIAGNOSTICS

			
	 By:
	 	 /s/ James White
	 	
Date: 
23rd October, 2007

 

							
	Name and Office:	 	 James White C.E.O.
	 	

					
	  
	 	

  

					
	 Reviewed by Marshfield Clinic’s Attorney:

		
	 /s/ illegible
	 	 Oct. 22, 2007

(Marshfield Clinic’s attorney shall not be deemed a signatory to this Agreement.) 

Marshfield Clinic Ref: Caldwell - M07015US 
  

					
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 APPENDIX A 

A. “Licensed Patents” shall refer to and mean those patents and patent applications listed on Appendix B
attached hereto in countries in the Licensed Territory and any subsequent patent application owned by MARSHFIELD CLINIC in a country in the Licensed Territory but only to the extent it claims priority to an invention claimed in a patent application
listed on Appendix B. This includes but is not limited to continuation applications, continuation-in-part applications to the extent they relate back to a parent Licensed Patent, divisional applications, reissue applications, utility model
applications or registrations, 
 B. “Products” shall refer to and mean any and all products that
employ or are in any way produced by the practice of an invention claimed in the Licensed Patents or that would otherwise constitute infringement of any claims of the Licensed Patents. 

C. “Selling Price” shall mean, in the case of Products that are sold or leased, the invoice price to the end
user of Products (regardless of uncollectible accounts) less any shipping costs, allowances because of returned Products, or sales taxes. The “Selling Price” for a Product that is transferred to a third party for promotional purposes
without charge or at a discount shall be the average invoice price to the end user of that type of Product during the applicable calendar quarter. 

D. “Development Report” shall mean a written account of Licensee’s progress under the development plan
having at least the information specified on Appendix D to this Agreement, and shall be sent to the address specified on Appendix D. 

E. “Licensed Field” shall be limited to the field of human diagnostic and research applications, expressly
excluding any pharmaceutical drug development and therapeutic uses. 
 F. “Licensed Territory”
shall be Worldwide 
 G. “Non-Commercial Research Purposes” shall mean the use of the inventions of
the Licensed Patents and/or Improvements for academic research purposes or other not-for-profit or scholarly purposes not involving the use of the inventions of the Licensed Patents or Improvements to perform services for a fee or for the production
or manufacture of products for sale to third parties. 
  

					
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 APPENDIX B 

LICENSED PATENTS 
  

									
	 REFERENCE NUMBER
	  	COUNTRY	  	PATENT
NUMBER	  	ISSUE
DATE	  	APPLICATION
SERIAL NUMBER
					
	Technology Title (Inventors...)	  		  		  		  	
	
	 M07015US “Test of rs2108622 in the gene CYP4F2 for predicting a patient’s starting dose of warfarin and subsequent dose
adjustments”

	
	 This invention provides a method for improving warfarin dosing and dose adjustment models by adding data from a genetic test about single nucleotide
polymorphism rs2108622 in the gene CYP4F2 (Cytochrome P450 4F2.

					
	 M07015US
	  	 UNITED STATES
	  		  		  	

 A provisional US application will be filed by October 22, 2007. Licensee has instructed WiSys to
file in US, Europe and Japan. US, Europe and Japan applications are included in the “Licensed Patents” 
  

					
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 APPENDIX C 

MARSHFIELD CLINIC ROYALTY REPORT 
  

																	
	Licensee:	 	 	 	 	  	        Agreement No:	  	 	  	 
	Inventor:	 	 	 	 	  	        P#:	  		  	
	Period Covered:From:	 	            /         
   /            	  	         Through
	  	            /       
     /            
	Prepared By:	 	 	 	 	  	        Date:	  	 	  	 	  	 	  	 	  	 
	Approved By:	 	 	 	 	  	        Date:	  	 	  	 	  	 	  	 	  	 

 If license covers several major
product lines, please prepare a separate report for each line. Then combine all product lines into a summary report. 
  

																					
	Report Type:	  	  ̈
	 	 Single Product Line Report:
	  	 
						
		  	  ̈
	 	 Multiproduct Summary Report.     Page 1 of
	 	 	  	 Pages
	  	
								
		  	  ̈
	 	 Product Line Detail. Line:
	  	 	 	 Tradename:
	 	 	 	     Page:
	 	 
					
	Report Currency:	  	  ̈
	 	 U.S. Dollars
	  	  ̈Other
	 	 

  

													
	 	  	 	  	 	  	 	  	 	  	Period Royalty
Amount
	 Country
	  	Gross
Sales	  	* Less:
Allowances	  	Net
Sales	  	Royalty
Rate	  	This Year	  	Last Year
	 U.S.A.
	  		  		  		  		  		  	
	 Canada
	  		  		  		  		  		  	
	 Europe:
	  		  		  		  		  		  	
							
	 Japan
	  		  		  		  		  		  	
	 Other:
	  		  		  		  		  		  	
							
	 TOTAL:
	  		  		  		  		  		  	

  

											
	 Total Royalty:
	 	  
	 	 Conversion Rate:
	 	  
	  	 Royalty in U.S. Dollars:
	  	 $

The following royalty forecast is non-binding and for Marshfield Clinic’s internal planning purposes only: 

 

													
	 Royalty Forecast Under This Agreement:
	  	 Next Quarter:
	  	 	  	 Q2:
	  	 	  	 Q3:
	  	 

													
	 Q4:
	  	 	  		  		  		  		  	

  

	*	 On a separate page, please indicate the reasons for returns or other adjustments if significant. 

Also note any unusual occurrences that affected royalty amounts during this period. 

To assist Marshfield Clinic’s forecasting, please comment on any significant expected trends in sales volume. 

 

					
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 APPENDIX D 

DEVELOPMENT REPORT 
  

	A.	 Date development plan initiated and time period covered by this report. 

 

	B.	 Development Report (4-8 paragraphs). 

  

	 	1.	 Activities completed since last report including the object and parameters of the development, when initiated, when completed and the results.

  

	 	2.	 Activities currently under investigation, i.e., ongoing activities including object and parameters of such activities, when initiated, and projected
date of completion. 

  

	C.	 Future Development Activities (4-8 paragraphs). 

 

	 	1.	 Activities to be undertaken before next report including, but not limited to, the type and object of any studies conducted and their projected
starting and completion dates. 

  

	 	2.	 Estimated total development time remaining before a product will be commercialized. 

 

	D.	 Changes to initial development plan (2-4 paragraphs). 

 

	 	1.	 Reasons for change. 

  

	 	2.	 Variables that may cause additional changes. 

  

	E.	 Items to be provided if applicable: 

  

	 	1.	 Information relating to Product that has become publicly available, e.g., published articles, competing products, patents, etc.

  

	 	2.	 Development work being performed by third parties other than Licensee to include name of third party, reasons for use of third party, planned future
uses of third parties including reasons why and type of work. 

  

	 	3.	 Update of competitive information trends in industry, government compliance (if applicable) and market plan. 

PLEASE SEND DEVELOPMENT REPORTS TO: 

WiSys Technology Foundation 

Attn: Contract Coordinator 

614 Walnut Street 

P.O. Box 7365 

Madison, WI 53707-7365 
  

 

					
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 APPENDIX E 

DEVELOPMENT PLAN 
  

					
	 4F2 Development Plan Activities
	  	 Timing
	  	 Status

	 1. XT-8 System Development
	  		  	
	 a. Assay (2C9 *2 *3 / VKORC1)
	  	Q3 ’07	  	Complete
	 b. Disposable
	  	Q3 ’07	  	Complete
	 c. Instrument
	  	Q3 ’07	  	Complete
	 d. Software
	  	Q3 ’07	  	Complete
	 e. Manufacturing process
	  	Q3 ’07	  	Complete
	 f. 4F2 assay development
	  	Q3 ’07	  	Complete
	 2. Manufacturing certification (ISO 13485:2003)
	  	Q4 ’07	  	Complete
	 3. Licensing
	  		  	
	 a. VKORC1
	  	Q2 ’07	  	Complete
	 b. 4F2
	  	Q4 ’07	  	
	 4. Clinical Trials (US)
	  		  	
	 a. Initiate
	  	Q4 ’07	  	
	 b. Complete
	  	Q1 ’08	  	
	 5. FDA 510K
	  		  	
	 a. Submission
	  	Q1 ’08	  	
	 b. Clearance
	  	Q3 ’08	  	
	 6. Commercial launch
	  		  	
	 a. US
	  	Q3 ’08	  	
	 b. Europe
	  	Q4 ’08	  	
	 c. Japan
	  	TBD*	  	
	 7. Initiate 4F2 sublicense activities
	  		  	
	 a. US
	  	Q1 ’08	  	
	 b. x-US
	  	Q2 ’08**	  	

 Notes: 

	*	 Japan launch based on 2 years post submission for government approval 

	**	 Dependant on Marshfield Clinic filing dates for patent applications in Europe and Japan 

 
  

					
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