Exhibit 10.1

 

AMENDED AND RESTATED

 

LICENSE AGREEMENT

 

BETWEEN

 

THE JOHNS HOPKINS UNIVERSITY

 

&

 

EXACT SCIENCES CORPORATION

 

JHU Ref: DM — 3562

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

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AMENDED AND RESTATED
LICENSE AGREEMENT

 

THIS AMENDED AND RESTATED LICENSE AGREEMENT (the “Agreement”) is entered into
this          day of             , 2003 (the “Effective Date”) by and between
THE JOHNS HOPKINS UNIVERSITY, a Maryland corporation having an address at 111
Market Place, Suite 906, Baltimore, MD 21202 (“JHU”), and EXACT SCIENCES
CORPORATION, a Delaware corporation having an address at 63 Great Road, Maynard,
MA 01754 (hereinafter “EXACT” or the “COMPANY”), with respect to the following:

 

RECITALS

 

WHEREAS, inventions identified by name and JHU reference numbers on Exhibit A
attached hereto and incorporated herein by this reference were developed during
the course of research by Drs. Bert Vogelstein (an employee of the Howard Hughes
Medical Institute, hereinafter “HHMI”), Kenneth W.  Kinzler and C. Giovanni
Traverso (all hereinafter “Inventors”); and

 

WHEREAS, JHU has acquired through assignment all rights, title and interest,
with the exception of certain retained rights by the United States government
and HHMI, in said inventions; and

 

WHEREAS, the COMPANY and JHU entered into a License Agreement effective as of
January 3, 2001 (the “PRIOR LICENSE AGREEMENT”) with regard to certain patent
rights related to JHU Ref.  No.  DM-3562;

 

WHEREAS, the parties now desire to amend and restate the PRIOR LICENSE AGREEMENT
in order to, among other things, modify and amend the terms applicable to the
license grant in respect of the patent application identified by JHU Ref.
No. DM-3562, to grant and establish the terms of a license in respect of
additional patent applications, and generally to establish incentives and to
memorialize the terms and conditions applicable to a long-term relationship
between the respective parties hereto.

 

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:

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.

 

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ARTICLE 1
DEFINITIONS

 

All references to Exhibits, Articles and Paragraphs shall mean the Exhibits to,
and Articles and Paragraphs of, this Agreement, unless otherwise specified.  For
the purposes of this Agreement the following words and phrases shall have the
following meanings in either singular or plural form:

 

1.1          “AFFILIATED COMPANY” SHALL MEAN ANY CORPORATION, COMPANY,
PARTNERSHIP, JOINT VENTURE OR OTHER PERSON OR ENTITY WHICH CONTROLS, IS
CONTROLLED BY OR UNDER COMMON CONTROL WITH, THE COMPANY.  FOR PURPOSES OF THIS
PARAGRAPH 1.1, CONTROL SHALL MEAN THE DIRECT OR INDIRECT OWNERSHIP OF AT LEAST
FIFTY PERCENT (50%) OF THE VOTING OR ECONOMIC INTEREST IN THE ENTITY. 
“AFFILIATE” SHALL HAVE THE CORRELATIVE MEANING.  SUBJECT TO PARAGRAPH 10.18
HEREOF, ALL REFERENCES TO COMPANY OR EXACT HEREIN SHALL BE DEEMED TO INCLUDE
ITS’ AFFILIATES.

 

1.2          “FECAL-BASED TEST” SHALL MEAN AN ASSAY ON A STOOL SAMPLE, FOR
DIAGNOSING COLORECTAL NEOPLASIA.  IN NO EVENT SHALL AN ASSAY THAT IS PERFORMED
FOR RESEARCH PURPOSES BE A FECAL-BASED TEST.

 

1.3          “PRODUCTS” SHALL MEAN ANY MATERIAL, COMPOSITIONS, OLIGONUCLEOTIDE,
REAGENT, INSTRUMENT (AS DEFINED BELOW), OR OTHER PRODUCT, THE MANUFACTURE, USE
OR SALE OF WHICH WOULD CONSTITUTE, BUT FOR THE LICENSE GRANTED TO COMPANY
PURSUANT TO THIS AGREEMENT, AN INFRINGEMENT OF A VALID CLAIM OF THE PATENT
RIGHTS.

 

1.4          “OTHER ITEMS” SHALL MEAN ANY PRODUCT OR SERVICE, OTHER THAN, AND IN
ANY EVENT EXCLUDING, ANY FECAL-BASED TEST.  IN NO EVENT SHALL A PRODUCT OR
SERVICE THAT IS USED FOR RESEARCH PURPOSES BE AN OTHER ITEM.

 

1.5          “FIRST COMMERCIAL SALE” SHALL MEAN THE INITIAL SALE OF A
FECAL-BASED TEST BY OR ON BEHALF OF THE COMPANY OR ANY SUBLICENSEE, IN EXCHANGE
FOR THE PAYMENT OF MONEY.  TRANSFER FOR RESEARCH PURPOSES SHALL NOT CONSTITUTE A
FIRST COMMERCIAL SALE.

 

1.6          “SUBLICENSEE” SHALL MEAN ANY PERSON OR ENTITY, OTHER THAN AN
AFFILIATED COMPANY, TO WHICH COMPANY HAS GRANTED A SUBLICENSE OF THE PATENT
RIGHTS UNDER THIS AGREEMENT.

 

1.7          “MOLECULAR GENETICS LAB” SHALL MEAN THE LABORATORY AT THE JOHNS
HOPKINS UNIVERSITY OPERATED BY BERT VOGELSTEIN, KENNETH KINZLER, OR BOTH, OR
OPERATED BY A SUCCESSOR OF EITHER BERT VOGELSTEIN OR KENNETH KINZLER AS MUTUALLY
AGREED TO BY COMPANY AND JHU.

 

1.8          “TECHNOLOGY” SHALL MEAN ANY MOLECULAR GENETICS LAB TECHNOLOGY THAT
IS USEFUL IN A FECAL BASED TEST (WHERE TECHNOLOGY SHALL BE CONSIDERED “USEFUL IN
A FECAL BASED TEST” IF A PATENT APPLICATION OR A PEER-REVIEWED PUBLICATION FROM
JHU STATES THAT THE TECHNOLOGY IS OR MAY BE USEFUL IN A FECAL BASED TEST, OR
PROVIDES DATA INDICATING SUCH USE) AND WHICH JHU OWNS OR IN WHICH JHU MAINTAINS
RIGHTS OR AN OWNERSHIP

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.

 

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INTEREST BUT IS NOT PROHIBITED FROM LICENSING TO COMPANY BY VIRTUE OF EITHER
(I) AN AGREEMENT EXECUTED PRIOR TO THE EFFECTIVE DATE OF THIS AGREEMENT AND AS
THE SAME MAY BE RENEWED, MODIFIED (BUT NOT TO INCLUDE A SCOPE OF WORK SPECIFIC
TO A FECAL BASED TEST) OR EXTENDED FROM TIME TO TIME, OR (II) ANY MATERIAL
TRANSFER AGREEMENT NOW OR HEREAFTER EXISTING AND TO WHICH JHU IS A PARTY
“TECHNOLOGIES” SHALL HAVE THE CORRELATIVE MEANING.

 

1.9          “COMPANY SALES” SHALL MEAN GROSS REVENUES RECEIVED BY COMPANY OR
ANY AFFILIATED COMPANY, LESS TRADE DISCOUNTS ALLOWED, REFUNDS, RETURNS AND
RECALLS, AND SALES AND USE TAXES.  IN THE EVENT THAT COMPANY OR ANY AFFILIATED
COMPANY SELLS ANY PRODUCT OR SERVICE IN COMBINATION WITH OTHER ACTIVE
INGREDIENTS OR SUBSTANCES, OR WITH OTHER SERVICES OR AS PART OF A KIT, THE
MANUFACTURE, USE, SALE OR IMPORTATION OF WHICH INGREDIENTS OR SUBSTANCES, OR THE
PERFORMANCE OF WHICH SERVICES, IN EACH CASE COMPRISING A PORTION OF THE
COMBINATION OR KIT, WOULD BE NON-INFRINGING (COLLECTIVELY, “OTHER ELEMENTS”),
THE COMPANY SALES ATTRIBUTABLE TO SUCH OTHER PRODUCT OR SERVICE SHALL BE
CALCULATED AS FOLLOWS:

 

(a)                                  If all OTHER ELEMENTS and all PRODUCTS
and/or SERVICES with which the same are combined or kitted are available
separately, the COMPANY SALES applicable thereto will be calculated by
[********].

 

(b)                                 If the combination or kit at issue includes
OTHER ELEMENTS which are not sold separately (but all of the PRODUCTS and/or
SERVICES contained in the combination or kit at issue are available separately),
the COMPANY SALES for purposes of royalty payments will be calculated by
[********].

 

(c)                                  If the PRODUCT and/or SERVICE contained in
the combination are not sold separately, the COMPANY SALES for such combination
shall be COMPANY SALES of such combination as defined in the first sentence of
this Paragraph 1.9, reduced, however by an amount negotiated and agreed to in
good faith by the parties hereto to reflect the relative fair values that the
PRODUCT and/or SERVICE, on the one hand, and the OTHER ELEMENTS, on the other,
as included in the combination or kit at issue, contributes to the overall value
thereof, but in no event shall the COMPANY SALES attributable to such
combination or kit be reduced by greater than [********].

 

The term “OTHER ELEMENTS” does not include solvents, diluents, carriers,
excipients, buffers (other than an EXACT patented buffer, as identified by U.S.
Patent Numbers 6268136, 6406857) or the like used in formulating or delivery of
a PRODUCT, SERVICE or OTHER ITEM.

 

1.10        “SUBLICENSEE SALES” SHALL MEAN GROSS REVENUES RECEIVED BY
SUBLICENSEES FROM THE SALE OR PERFORMANCE OF OTHER ITEMS, LESS TRADE DISCOUNTS
ALLOWED, REFUNDS, RETURNS AND RECALLS, AND SALES AND USE TAXES.  IN THE EVENT
THAT SUBLICENSEE SELLS OTHER ITEMS IN COMBINATION WITH OTHER ELEMENTS, THE
SUBLICENSEE SALES ATTRIBUTABLE TO SUCH OTHER ITEMS SHALL BE CALCULATED AS
FOLLOWS:

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

2

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(a)                                  If all OTHER ELEMENTS and all OTHER ITEMS
with which the same are combined or kitted are available separately, the
SUBLICENSEE SALES will be calculated by [********].

 

(b)                                 If the combination or kit at issue includes
OTHER ELEMENTS which are not sold separately (but all of the OTHER ITEMS
contained in the combination or kit at issue are available separately), the
SUBLICENSEE SALES will be calculated by [********].

 

(c)                                  If the OTHER ITEMS contained in the
combination are not sold separately, the SUBLICENSEE SALES for such combination
shall be SUBLICENSEE SALES of such combination as defined in the first sentence
of this Paragraph 1.10, reduced, however by an amount negotiated and agreed to
in good faith by the parties hereto to reflect the relative fair values that the
OTHER ITEM, on the one hand, and the OTHER ELEMENTS, on the other, as included
in the combination or kit at issue, contributes to the overall value thereof,
but in no event shall the SUBLICENSEE SALES attributable to such combination or
kit be reduced by greater than [********].

 

1.11        “COMPANY ROYALTIES” SHALL MEAN GROSS ROYALTIES RECEIVED BY COMPANY
FROM SUB LICENSEES FROM THE SALE OR PERFORMANCE OF FECAL BASED TESTS (OTHER THAN
AND EXCLUDING OTHER ITEMS).  FOR THE AVOIDANCE OF DOUBT, COMPANY ROYALTIES SHALL
NOT INCLUDE ANY PAYMENTS OTHER THAN ROYALTY PAYMENTS RECEIVED BY COMPANY AND
COMPANY ROYALTIES SHALL EXPRESSLY EXCLUDE ALL OTHER PAYMENTS OF ANY KIND AND
NATURE INCLUDING, WITHOUT LIMITATION, SUBLICENSE ISSUE FEES, MILESTONE PAYMENTS,
MAINTENANCE FEES, ETC.

 

1.12        “ANNUAL LICENSE FEE” SHALL MEAN THE FOLLOWING:

 

1.12.1                  INITIALLY, “ANNUAL LICENSE FEE” SHALL MEAN THE GREATER
OF:

 

(A)                                  [********]; AND

 

(B)                                 THE SUM OF:

 

(I)                                     THE COMBINATION OF:

 

(1)                                  THE GREATER OF [********] OF COMPANY SALES,
OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL BASED TESTS
THAT ARE SOLD AS A PRODUCT, PLUS

 

(2)                                  THE GREATER OF [********] OF COMPANY SALES,
OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL BASED TESTS
THAT ARE SOLD AS A SERVICE, PLUS

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

3

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(3)                                  THE GREATER OF [********] OF COMPANY
ROYALTIES, OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL
BASED TESTS THAT ARE SOLD AS A PRODUCT, PLUS

 

(4)                                  THE GREATER OF [********] OF COMPANY
ROYALTIES, OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL
BASED TESTS THAT ARE SOLD AS A SERVICE,

 

PLUS

 

(II)                                  THE COMBINATION OF:

 

(1)                                  [********] OF COMPANY SALES ATTRIBUTABLE TO
THE SALE OF NON-INFRINGING FECAL BASED TESTS THAT ARE SOLD AS A SERVICE, PLUS

 

(2)                                  THE GREATER OF (X) [********] OF COMPANY
ROYALTIES ATTRIBUTABLE TO THE SALE OF NON-INFRINGING FECAL BASED TESTS THAT ARE
SOLD AS A SERVICE, AND (Y) [********] OF COMPANY ROYALTIES ATTRIBUTABLE TO THE
SALE OF NON-INFRINGING FECAL BASED TESTS THAT ARE SOLD AS A PRODUCT,

 

PLUS

 

(III)                               [********] OF COMPANY SALES AND SUBLICENSEE
SALES ATTRIBUTABLE TO THE SALE OF OTHER ITEMS THAT ARE SOLD AS PRODUCTS OR
SERVICES.

 

For the avoidance of confusion, and by way of example, if the resulting
calculations from 1.12.1(b)i.1-4, 1.12.1(b) ii.1 and 2, and 1.12.1(b)iii, above
are [********], respectively, then the ANNUAL FEE under this section 1.12.1 for
such year would equal [********].  Conversely, if the resulting calculations
from 1.12.1(b)i.1-4, 1.12.1(h) ii.1 and 2, and 1.12.1(b)iii, above are
[********], respectively, then the ANNUAL FEE under this section 1.12.1 for such
year would equal [********] (the amounts due pursuant to 1.12.1(a)).

 

1.12.2                 PROVIDED, HOWEVER, THAT, NOTWITHSTANDING 1.12.1, IF IN
ANY CALENDAR YEAR EXACT OR SUBLICENSEE SELLS TWO OR MORE FECAL BASED TESTS
SIMULTANEOUSLY FOR A PERIOD EXCEEDING NINETY (90) DAYS (AS EVIDENCED BY REGULAR
AND ORDINARY SHIPMENTS OR PERFORMANCE OVER SUCH NINETY (90) DAY PERIOD), THE
SALE OF AT LEAST ONE OF WHICH FECAL BASED TEST WOULD BE INFRINGING AND THE SALE
OF AT LEAST ONE OF WHICH FECAL BASED TESTS IS NON-INFRINGING, THEN THE “ANNUAL
LICENSE FEE” FOR THAT CALENDAR YEAR SHALL INSTEAD MEAN THE GREATER OF:

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS..

 

4

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(A)                                  [********]; AND

 

(B)                                 THE GREATER OF (I) AND (II), IMMEDIATELY
BELOW, PLUS (III):

 

(I)                                     THE COMBINATION OF:

 

(1)                                  THE GREATER OF [********] OF COMPANY SALES,
OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL BASED TESTS
THAT ARE SOLD AS A PRODUCT, PLUS

 

(2)                                  THE GREATER OF [********] OF COMPANY SALES,
OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OR PERFORMANCE OF INFRINGING
FECAL BASED TESTS THAT ARE SOLD AS A SERVICE, PLUS

 

(3)                                  THE GREATER OF [********] OF COMPANY
ROYALTIES, OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL
BASED TESTS THAT ARE SOLD AS A PRODUCT, PLUS

 

(4)                                  THE GREATER OF [********] OF COMPANY
ROYALTIES, OR [********] PER TEST, ATTRIBUTABLE TO THE SALE OF INFRINGING FECAL
BASED TESTS THAT ARE SOLD AS A SERVICE, AND

 

(II)                                  THE COMBINATION OF:

 

(1)                                  [********] OF COMPANY SALES ATTRIBUTABLE TO
THE SALE OF NON-INFRINGING FECAL BASED TESTS THAT ARE SOLD AS A SERVICE, PLUS

 

(2)                                  THE GREATER OF (X) [********] OF COMPANY
ROYALTIES ATTRIBUTABLE TO THE SALE OF NON-INFRINGING FECAL BASED TESTS THAT ARE
SOLD AS A SERVICE, AND (Y) [********] OF COMPANY ROYALTIES ATTRIBUTABLE TO THE
SALE OF NON-INFRINGING FECAL BASED TESTS THAT ARE SOLD AS A PRODUCT

 

PLUS

 

(III)                               [********] OF COMPANY SALES AND SUBLICENSEE
SALES ATTRIBUTABLE TO THE SALE OF OTHER ITEMS THAT ARE SOLD AS PRODUCTS OR
SERVICES.

 

For the avoidance of confusion, and by way of example, if the resulting
calculations from 1.12.2(b)i.1-4, 1.12.2(b)ii.1 and 2, and 1.12.2(b)iii., above
are [********], respectively, then the

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

5

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ANNUAL FEE under this section 1.12.2 for such year would equal [********]. 
Conversely, if the resulting calculations from 1.12.2(b)i.1-4, 1.12.2(b)ii.1 and
2, and 1.12.2(b)iii., above are [********], respectively, then the ANNUAL FEE
under this section 1.12.1 for such year would equal [********] (the amounts due
pursuant to 1.12.1(a)).

 

1.13        “PATENT RIGHTS” SHALL MEAN: THOSE PATENTS AND PATENT APPLICATIONS
IDENTIFIED IN EXHIBIT A ATTACHED HERETO AND THE INVENTIONS DISCLOSED AND CLAIMED
THEREIN; ANY U.S. PATENTS ISSUED FROM THE APPLICATIONS LISTED IN EXHIBIT A, AND
ALL CONTINUATIONS, DIVISIONS, RE-EXAMS AND REISSUES BASED ON ANY OF THE
FOREGOING; CLAIMS OF CONTINUATION-IN-PART APPLICATIONS, PATENTS AND OTHER
INTELLECTUAL PROPERTY RIGHTS WHICH ARE DIRECTED TO SUBJECT MATTER SPECIFICALLY
DESCRIBED IN THE APPLICATIONS LISTED IN EXHIBIT A; AND CLAIMS OF ALL FOREIGN
(X) PATENT APPLICATIONS, (Y) PATENTS, AND (Z) OTHER INTELLECTUAL PROPERTY
RIGHTS, WHICH IN THE CASE OF EACH OF (X), (Y) AND (Z) ABOVE ARE DIRECTED TO
SUBJECT MATTER SPECIFICALLY DESCRIBED IN THE UNITED STATES PATENTS AND/OR PATENT
APPLICATIONS LISTED IN EXHIBIT A.  FOR THE AVOIDANCE OF CONFUSION, PATENT RIGHTS
INCLUDES THE EXACT OVERSEEN PATENT RIGHTS AND THE JHU OVERSEEN PATENT RIGHTS.

 

1.14        “RESEARCH PURPOSES” SHALL MEAN USE OF ANY ASSAY OR OTHER PRODUCT OR
PROCESS, IN BASIC AND APPLIED RESEARCH, OR CLINICAL TRIALS, WHETHER OR NOT
PERFORMED IN CONNECTION WITH THE COMMERCIALIZATION OF ANY PRODUCT OR SERVICE,
REGARDLESS OF THE SETTING IN WHICH SUCH RESEARCH IS CONDUCTED.

 

1.15        “FIELD” SHALL MEAN ALL FIELDS OF USE OR ENDEAVOR WITHOUT ANY
LIMITATION WHATSOEVER.

 

1.16        “EXACT OVERSEEN PATENT RIGHTS” SHALL MEAN ALL NEW CONTINUATIONS AND
DIVISIONS, FOREIGN AND DOMESTIC, THAT, IN EACH CASE, ARE FILED SUBSEQUENT TO THE
EFFECTIVE DATE AND RELATE TO THOSE PATENTS AND PATENT APPLICATIONS INCLUDED
AMONG THE PATENT RIGHTS EXISTING AS OF THE EFFECTIVE DATE, ANY CORRESPONDING
RE-EXAMS AND RE-ISSUES BASED ON ANY OF THE FOREGOING, AND CLAIMS OF
CONTINUATIONS IN PART APPLICATIONS DOMESTIC AND, IF ANY, FOREIGN DIRECTED TO THE
SUBJECT MATTER SPECIFICALLY DESCRIBED IN THOSE PATENTS AND PATENT APPLICATIONS
DESCRIBED IN PATENT RIGHTS EXISTING AS OF THE EFFECTIVE DATE.

 

1.17        “JHU OVERSEEN PATENT RIGHTS” SHALL MEAN ALL OF THE PATENT RIGHTS
OTHER THAN AND IN ANY EVENT EXCLUDING THE EXACT OVERSEEN PATENT RIGHTS.

 

1.18        “MATERIAL TRANSFER AGREEMENT” SHALL MEAN AN AGREEMENT WHICH SETS
FORTH THE TERMS AND CONDITIONS, INCLUDING, WITHOUT LIMITATION, TERMS RELATIVE TO
INTELLECTUAL PROPERTY RIGHTS AND OWNERSHIP, ON THE BASIS OF WHICH JHU, AND THE
MOLECULAR GENETICS LAB SPECIFICALLY, AGREE TO RECEIVE AND ACCEPT BIOLOGICAL AND
OTHER MATERIALS FROM THIRD PARTIES FOR USE IN FURTHERANCE OF RESEARCH AND
DEVELOPMENT WORK UNDERTAKEN OR PERFORMED FROM TIME TO TIME.

 

1.19        “VALID CLAIM” SHALL MEAN A CLAIM OF AN ISSUED AND UNEXPIRED PATENT
INCLUDED IN THE PATENT RIGHTS WHICH HAS NOT BEEN HELD UNENFORCEABLE,
UNPATENTABLE OR INVALID BY A DECISION OF A COURT OR GOVERNMENTAL AGENCY OF
COMPETENT JURISDICTION, UNAPPEALABLE OR UNAPPEALED WITHIN THE TIME SET FORTH FOR
APPEAL, AND WHICH HAS NOT BEEN ADMITTED TO BE INVALID OR

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

6

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UNENFORCEABLE THROUGH REEXAMINATION, REISSUE, DISCLAIMER OR SIMILAR PROCEEDINGS
OR IS NOT SUBJECT TO RESTRICTION BY INJUNCTION.

 

1.20        “INSTRUMENT” SHALL MEAN DEVICES (WHICH MAY OR MAY NOT BE PATENTABLE)
DEVELOPED BY OR FOR COMPANY FOR USE IN RESEARCH AND DIAGNOSTIC TESTING, AND
WHICH DEVICE EMPLOYS ONE OR MORE FECAL BASED TEST OR EMPLOYS ONE OR MORE OTHER
ITEM.

 

1.21        “SERVICE” SHALL MEAN THE PERFORMANCE BY OR 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 THE
COMPANY PURSUANT TO THIS AGREEMENT, AN INFRINGEMENT OF A VALID CLAIM UNDER THE
PATENT RIGHTS.

 

1.22        “INFRINGING” SHALL MEAN THAT, BUT FOR THIS AGREEMENT, THE PRODUCT OR
SERVICE REFERRED TO WOULD INFRINGE A VALID CLAIM OF THE PATENT RIGHTS (AND SHALL
INCLUDE, BUT NOT BE LIMITED TO, DIRECT INFRINGEMENT, CONTRIBUTORY INFRINGEMENT
AND INDUCEMENT TO INFRINGE).  “INFRINGE” AND “INFRINGEMENT” SHALL HAVE
CORRELATIVE MEANINGS.

 

1.23        “NON-INFRINGING” SHALL MEAN THAT, IN THE ABSENCE OF THIS AGREEMENT,
THE PRODUCT OR SERVICE REFERRED TO WOULD NOT INFRINGE A VALID CLAIM OF THE
PATENT RIGHTS.

 

1.24        “REMAINING YEARS” (I) DURING THE FIRST TEN (10) YEARS OF THIS
AGREEMENT’S TERM, SHALL MEAN TWENTY (20) YEARS, MINUS THE NUMBER OF WHOLE YEARS
THAT THIS AGREEMENT HAS BEEN IN EFFECT AS OF THE DATE OF THE RELEVANT
CALCULATION, AND (II) FOLLOWING THE TENTH YEAR AFTER THE EFFECTIVE DATE OF THIS
AGREEMENT SHALL MEAN TEN (10) YEARS.  PAYMENTS BEING MADE TO JHU DURING THE
REMAINING YEARS SHALL NOT CEASE BECAUSE THIS AGREEMENT’S TERM SHALL EXPIRE
(X) IN ACCORDANCE WITH PARAGRAPH 9.1, OR, (Y) IN ACCORDANCE WITH PARAGRAPH
9.2(A) PRIOR TO COMPANY’S COMPLETION OF ALL PAYMENTS DUE OVER THE REMAINING
YEARS.

 

ARTICLE 2
LICENSE GRANT, PRIOR AGREEMENT

 

2.1          GRANT.  SUBJECT TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, AND
EXPRESSLY SUBJECT TO ARTICLE 2.3 HEREIN, JHU HEREBY GRANTS TO COMPANY AN
EXCLUSIVE LICENSE UNDER THE PATENT RIGHTS IN THE FIELD TO MAKE, HAVE MADE, USE,
HAVE USED, SELL, HAVE SOLD, IMPORT, AND HAVE IMPORTED ANY METHOD OR PRODUCT
WORLDWIDE.

 

2.2          SUBLICENSE.  COMPANY MAY SUBLICENSE OTHERS UNDER THIS AGREEMENT SO
LONG AS SUCH SUBLICENSE INCLUDES PROVISIONS FOR THE BENEFIT OF JHU AND HHMI
MATERIALLY CONSISTENT WITH THE FOLLOWING SECTIONS OF THIS AGREEMENT: PARAGRAPH
2.3, 5.2, 6.1, 7.1, ARTICLE 8, 9.4, 10.1, 10.4 AND 10.19.  JHU SHALL HAVE THE
RIGHT TO REVIEW ALL SUCH SUBLICENSES, PRIOR TO EXECUTION, FOR A PERIOD OF UP TO
TEN (10) DAYS (THE “REVIEW PERIOD”) OF RECEIPT OF THE SUBLICENSE FROM COMPANY TO
CONFIRM THAT THE SUBLICENSE CONTAINS THE PROVISIONS REFERENCED ABOVE AND COMPANY
SHALL CONSIDER JHU’S COMMENTS, IF ANY, REGARDING THE CONTENT AND SCOPE OF THE
SUBLICENSE AS DRAFTED.  NOTWITHSTANDING THE FOREGOING, ALTHOUGH COMPANY WILL NOT
ENTER INTO ANY SUBLICENSE PRIOR TO THE EXPIRATION OF THE REVIEW PERIOD,
COMPANY’S RIGHT TO GRANT SUBLICENSES UNDER THE PATENT RIGHTS SHALL NOT BE
CONTINGENT UPON COMPANY’S RECEIPT OF JHU’S PRIOR

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

7

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APPROVAL.  COMPANY AGREES TO PROVIDE JHU WITH A COPY OF EACH EXECUTED SUBLICENSE
AGREEMENT PROMPTLY UPON ITS EXECUTION (AND IN ANY EVENT WITHIN TEN (10) DAYS
THEREAFTER).  EACH SUBLICENSE SHALL SPECIFICALLY REFERENCE AND GIVE RECOGNITION
TO THIS AGREEMENT AND SHALL IN ANY EVENT NOT CONFLICT WITH THE TERMS OF THIS
AGREEMENT NOR EXCEED THE SCOPE OF SUBLICENSING AUTHORITY GRANTED TO COMPANY,
UNDER THIS AGREEMENT.

 

2.3          RETAINED RIGHTS.  THE RIGHT AND LICENSE GRANTED HEREUNDER IN
RESPECT OF THE PATENT RIGHTS AND OTHERWISE, SHALL BE AND IS, ANYTHING HEREIN TO
THE CONTRARY NOTWITHSTANDING, GRANTED AND MADE SUBJECT TO RIGHTS RETAINED BY THE
UNITED STATES GOVERNMENT IN ACCORDANCE WITH P.L. 96-517, AS AMENDED BY P.L.
98-620, AND HHMI’S PAID-UP, NON-EXCLUSIVE, IRREVOCABLE LICENSE TO USE THE PATENT
RIGHTS FOR HHMI’S NON-COMMERCIAL PURPOSES, BUT WITH NO RIGHT TO ASSIGN OR
SUBLICENSE.  THE RIGHT AND LICENSE GRANTED HEREUNDER IN RESPECT OF THE PATENT
RIGHTS AND OTHERWISE, SHALL BE AND IS, FURTHER SUBJECT TO THE RETAINED RIGHT OF
JHU TO USE THE PATENT RIGHTS AND TO MAKE, HAVE MADE, PROVIDE AND USE FECAL BASED
TESTS, AND PRODUCTS AND SERVICES FOR ITS AND ONLY THE JOHNS HOPKINS HEALTH
SYSTEMS’ INTERNAL, NON-PROFIT, NON-COMMERCIAL PURPOSES, INCLUDING THE ABILITY TO
DISTRIBUTE ANY BIOLOGICAL MATERIAL COVERED UNDER ANY PATENT RIGHT FOR NON-PROFIT
ACADEMIC RESEARCH USE TO NON-COMMERCIAL ENTITIES AS IS CUSTOMARY IN THE
SCIENTIFIC ACADEMIC COMMUNITY; AND SUBJECT TO ANY ADDITIONAL LIMITATIONS,
CONDITIONS OR RESTRICTIONS, INCLUDED OR OTHERWISE REFERRED TO HEREIN.

 

2.4          PRIOR LICENSE AGREEMENT.  THIS AGREEMENT AMENDS AND RESTATES IN ITS
ENTIRETY THE PRIOR LICENSE AGREEMENT; PROVIDED, HOWEVER SUCH AMENDMENT AND
RESTATEMENT SHALL NOT RENDER NULL OR VOID THE PRIOR LICENSE AGREEMENT AS
RESPECTS OBLIGATIONS ACCRUING UNDER THE PRIOR LICENSE AGREEMENT PRIOR TO THE
EFFECTIVE DATE.  EXACT REPRESENTS AND WARRANTS THAT, AS OF THE EFFECTIVE DATE,
NO SUBLICENSES HAVE BEEN GRANTED BY EXACT UNDER THE PRIOR LICENSE AGREEMENT OR
UNDER THE PATENT RIGHTS COVERED THEREBY.  EXACT AND JHU REPRESENT AND WARRANT
THAT AS OF THE EFFECTIVE DATE ALL LICENSE FEES, ROYALTIES, MILESTONE PAYMENTS,
SIMILAR AMOUNTS AND MAINTENANCE FEES (THE “FEES”) REQUIRED TO BE PAID FROM EXACT
TO JHU UNDER THE PRIOR LICENSE AGREEMENT HAVE BEEN PAID IN FULL AND NO
ADDITIONAL FEES ARE DUE JHU FROM EXACT RELATING TO THE PRIOR LICENSE AGREEMENT.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

8

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ARTICLE 3
FEES AND PAYMENTS

 

3.1          INITIAL LICENSE FEE.  UPON EXECUTION OF THIS AGREEMENT, COMPANY
SHALL BECOME OBLIGATED TO MAKE PAYMENT TO JHU OF AN INITIAL LICENSE FEE IN THE
AMOUNT OF [********] (THE “INITIAL LICENSE FEE”).  JHU WILL NOT SUBMIT AN
INVOICE FOR THE INITIAL LICENSE FEE, WHICH IS NON-REFUNDABLE AND SHALL NOT BE
CREDITED AGAINST ANY ROYALTIES OR OTHER FEES OTHERWISE ARISING OR BECOMING DUE
UNDER THE TERMS OF THIS AGREEMENT.  PAYMENT OF THE INITIAL LICENSE FEE AS
CONTEMPLATED BY THE IMMEDIATELY PRECEDING SENTENCES SHALL BE MADE IN FOUR
(4) EQUAL INSTALLMENTS OF [********] EACH, THE FIRST OF WHICH SHALL BE DUE AND
PAYABLE ON OR BEFORE MARCH 31, 2003, THE SECOND OF WHICH ON OR BEFORE JUNE 30,
2003, THE THIRD OF WHICH ON OR BEFORE OCTOBER 30, 2003, AND THE FOURTH AND FINAL
OF WHICH WILL BE DUE AND PAYABLE ON OR BEFORE DECEMBER 31, 2003.

 

3.2          CALCULATION OF PAYMENTS DUE.  COMPANY HEREBY AGREES TO PAY THE
ANNUAL LICENSE FEE TO JHU, IN ACCORDANCE WITH THE PAYMENT SCHEDULE IN PARAGRAPH
3.3 BELOW, FOR EACH CALENDAR YEAR IN WHICH THIS AGREEMENT IS IN EFFECT.

 

3.3          PAYMENT SCHEDULE.  PAYMENTS ACCRUING FROM COMPANY TO JHU PURSUANT
TO PARAGRAPH 3.2 SHALL BE PAYABLE IN THE CALENDAR YEAR FOLLOWING THE CLOSE OF
THE CALENDAR YEAR WHICH SERVES AS THE MEASUREMENT YEAR IN RESPECT THEREOF, AND
SUCH PAYMENTS SHALL BE MADE IN TWO (2) EQUAL INSTALLMENTS, WHICH SHALL BE DUE
AND PAYABLE THIRTY (30) DAYS AFTER EACH OF JUNE 30 AND DECEMBER 31,
RESPECTIVELY.  FOR AVOIDANCE OF DOUBT, THE FIRST PAYMENT UNDER PARAGRAPH 3.2
WILL BE DUE AND PAYABLE THIRTY (30) DAYS AFTER JUNE 30, 2004.  THE ANNUAL
LICENSE FEE SHALL BE NON-REFUNDABLE AND SHALL NOT BE CREDITED AGAINST ROYALTIES
OR OTHER FEES ACCRUING UNDER THIS AGREEMENT.

 

3.4          AMENDMENT OF THE ANNUAL LICENSE FEE.  NOTWITHSTANDING ANYTHING TO
THE CONTRARY HEREIN, AT SUCH TIME AS:

 

(A)                                  CUMULATIVE PAYMENTS MADE PURSUANT TO
PARAGRAPH 4.9 BELOW (THE “DEFENSE COSTS”), AND MADE TO JHU PURSUANT TO
PARAGRAPHS 1.12.1(A) AND 1.12.2(A) (THE “MINIMUM JHU PAYMENTS”), AND
1.12.1(B)(II), 1.12.2(B)(II) (THE “PRIMARY JHU PAYMENTS”), TOGETHER REACH
[********] (THE “CUMULATIVE CAP”), THE ANNUAL LICENSE FEE WILL THEREAFTER BE
CALCULATED USING ONLY PARAGRAPHS 1.12.1(A), 1.12.1 (B)(I) 1-4, 1.12.1(B)(III),
1.12.2(A), 1.12.2(B)(I)1-4, AND 1.12.2(B)(III) ABOVE, AS APPLICABLE (THE
PAYMENTS ACCRUING UNDER PARAGRAPHS 1.12.1(A), 1.12.1 (B)(I) 1-4,
1.12.1(B)(III) 1.12.2(A), 1.12.2(B)(I)1-4, AND 1.12.2(B)(III), AS APPLICABLE,
BEING COLLECTIVELY REFERRED TO HEREIN AS THE “SECONDARY JHU PAYMENTS”).

 

and the term ANNUAL LICENSE FEE shall then be deemed amended accordingly;

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.

 

9

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(B)                                 EXACT HAS PAID [********] IN DEFENSE COSTS
(AS DEFINED IN PARAGRAPH 4.9 BELOW), THE ANNUAL LICENSE FEE WILL BE CALCULATED
AS AN AMOUNT EQUAL TO:

 

(I)                                     THE CUMULATIVE CAP, MINUS [********],
MINUS THE MINIMUM JHU PAYMENTS AND THE PRIMARY JHU PAYMENTS THEN PAID TO DATE,
WITH THE RESULT OF THIS CALCULATION THEN DIVIDED BY THE REMAINING YEARS, PLUS

 

(II)                                  IF AND AS ARISING, THE SECONDARY JHU
PAYMENTS FOR THE BALANCE OF THE TERM OF THIS AGREEMENT (EXCEPT THAT PAYMENTS TO
JHU UNDER PARAGRAPHS 1.12.1(A) AND 1.12.2(A) SHALL NOT AGAIN ACCRUE OR BE DUE
JHU UNTIL ALL AMOUNTS DUE JHU UNDER 3.4(B)(I) ABOVE HAVE BEEN PAID IN FULL),
UNLESS, BASED ON CIRCUMSTANCES ARISING PRIOR TO THIS AGREEMENT’S EXPIRATION, AN
ALTERNATE SECTION UNDER THIS PARAGRAPH 3.4 BECOMES APPLICABLE, AT WHICH TIME
SUCH APPLICABLE SECTION SHALL THEN GOVERN,

 

and the term “ANNUAL LICENSE FEE” shall be deemed amended accordingly;

 

(C)                                  EXACT HAS PAID DEFENSE COSTS IN AN AMOUNT
LESS THAN [********] AND EXACT AND ITS SUBLICENSEE(S) ARE PERMANENTLY ENJOINED
IN ALL OF THE UNITED STATES (AND ALL RIGHTS OF APPEAL HAVE EXPIRED OR BEEN
EXHAUSTED) FROM SELLING ALL INFRINGING FECAL BASED TESTS AND OTHER ITEMS, WHICH
EXACT OR AN AFFILIATED COMPANY OR SUBLICENSEE WAS SELLING PRIOR TO BEING
ENJOINED THEREFROM, THEN THE ANNUAL LICENSE FEE SHALL BE CALCULATED AS AN AMOUNT
EQUAL TO:

 

(I)                                     [********], MINUS THE SUM OF THE MINIMUM
JHU PAYMENTS AND PRIMARY JHU PAYMENTS THEN PAID TO DATE, ALL DIVIDED BY THE
REMAINING YEARS, WITH NO ADDITIONAL AMOUNTS ACCRUING TO JHU UNDER THIS
AGREEMENT,

 

and the term “ANNUAL LICENSE FEE” shall be deemed amended accordingly,

 

unless and until such time thereafter as additional TECHNOLOGY (which is not
subject to enjoinment) is included among the PATENT RIGHTS as contemplated by
Paragraph 9.3 hereof, or EXACT or an AFFILIATED COMPANY or SUBLICENSEE again
commence to sell any INFRINGING FECAL BASED TEST or OTHER ITEM, whereupon the
ANNUAL LICENSE FEE shall be calculated as an amount equal to:

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

10

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(II)                                  THE UNPAID AMOUNTS DESCRIBED IN PARAGRAPH
3.4(C)(I) ABOVE WHICH SHALL CONTINUE TO BE PAID OVER THE REMAINING YEARS (IN
LIEU OF FURTHER MINIMUM PAYMENTS), PLUS

 

(III)                               THE PRIMARY JHU PAYMENTS, UNTIL SUCH TIME AS
THE AGGREGATE OF DEFENSE COSTS PAID, PRIMARY JHU PAYMENTS PAID, AND ALL AMOUNTS
FOR WHICH EXACT IS THEN OBLIGATED TO MAKE PAYMENT IN THE FUTURE PURSUANT TO
PARAGRAPHS 3.4(B)(I) AND 3.4(C)(I) ABOVE, EQUAL THE CUMULATIVE CAP, WHEREUPON
PAYMENTS UNDER THE PRIMARY JHU PAYMENTS WILL CEASE; PLUS

 

(IV)                              THE SECONDARY JHU PAYMENTS FOR THE BALANCE OF
THE TERM OF THIS AGREEMENT, EXCEPT THAT PAYMENTS TO JHU UNDER PARAGRAPHS
1.12.1(A) AND 1.12.2(A) SHALL NOT AGAIN ACCRUE OR BE DUE JHU UNTIL ALL AMOUNTS
DUE JHU UNDER 3.4(C)(I) ABOVE HAVE BEEN PAID IN FULL.

 

and the term “ANNUAL LICENSE FEE” shall be deemed amended accordingly;

 

(D)                                 EXACT HAS PAID DEFENSE COSTS IN AN AMOUNT
EQUAL TO LESS THAN [********] AND EXACT, ITS AFFILIATED COMPANIES AND
SUBLICENSEE(S) ARE TEMPORARILY ENJOINED IN ALL OF THE UNITED STATES FOR A PERIOD
OF TIME (THE “RESTRAINED PERIOD”) FROM SELLING ALL INFRINGING FECAL BASED TESTS
AND OTHER ITEMS WHICH EXACT OR AN AFFILIATED COMPANY OR SUBLICENSEE WERE SELLING
PRIOR TO BEING TEMPORARILY ENJOINED THEREFROM, THEN THE ANNUAL LICENSE FEE SHALL
BE CALCULATED AS AN AMOUNT EQUAL TO:

 

(I)                                     [********] PER YEAR WITH NO ADDITIONAL
AMOUNTS DUE JHU UNDER THIS AGREEMENT (INCLUDING THE CESSATION OF ANY AMOUNTS
THEN BEING PAID TO JHU UNDER PARAGRAPH 3.4(C)(I) OR 3.4(B)(I) ABOVE),

 

and the term “ANNUAL LICENSE FEE” shall be deemed amended accordingly,

 

unless and until at any time thereafter:

 

(II)                                  THE TEMPORARY INJUNCTION BECOMES PERMANENT
(AND ALL RIGHTS OF APPEAL HAVE EXPIRED OR BEEN EXHAUSTED) IN ALL OF THE UNITED
STATES, IN WHICH CASE THE PROVISIONS OF PARAGRAPH 3.4(C) ABOVE SHALL GOVERN AND
REPLACE ANY AMOUNTS THEN BEING PAID TO JHU UNDER PARAGRAPH 3.4(D)(I) ABOVE; OR

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

11

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(III)                               THE TEMPORARY INJUNCTION LAPSES OR IS LIFTED
OR REMOVED AND EXACT OR ANY AFFILIATED COMPANY OR SUBLICENSEE IS AGAIN LAWFULLY
ABLE TO SELL IN THE UNITED STATES THE INFRINGING FECAL BASED TESTS AND OTHER
ITEMS THAT EXACT, ITS AFFILIATED COMPANY AND SUBLICENSEE WERE SELLING PRIOR TO
ISSUANCE OF THE TEMPORARY INJUNCTION, AT WHICH TIME THE OBLIGATIONS TO MAKE
PAYMENT OF THE ANNUAL LICENSE FEE SHALL RECOMMENCE AS THOUGH THE TEMPORARY
INJUNCTION HAD NEVER BEEN ISSUED, EXCEPT THAT EXACT SHALL THEN BE OBLIGATED TO
PAY JHU, IN ACCORDANCE WITH THE PAYMENT SCHEDULE SET FORTH IN SECTION 3.3
HEREOF, AN ADDITIONAL ONE TIME PAYMENT IN AN AMOUNT NECESSARY TO MAKE JHU WHOLE
FOR ANY PAYMENTS SUSPENDED DURING THE RESTRICTION PERIOD, AND ANY UNACCRUED
DEFENSE COSTS LESS THAN [********] SHALL THEREAFTER REMAIN AVAILABLE FOR ACCRUAL
AGAINST THE CUMULATIVE CAP FOR PURPOSES OF ANY SUBSEQUENT APPLICATION OF THE
TERMS AND PROVISIONS OF THIS PARAGRAPH 3.4,

 

and the ANNUAL LICENSE FEE shall be deemed amended accordingly;

 

(E)                                  THE MOLECULAR GENETICS LAB SHOULD CEASE TO
OPERATE FOR ANY REASON (INCLUDING THE FAILURE OF COMPANY AND JHU TO CHOOSE A
MUTUALLY AGREED UPON SUCCESSOR TO DRS. BERT VOGELSTEIN AND KENNETH KINZLER
SUBSEQUENT TO SUCH TIME AS NEITHER DR. VOGELSTEIN NOR DR. KINZLER CONTINUED TO
OPERATE THE LAB), EXACT SHALL ONLY HAVE CONTINUING PAYMENT OBLIGATIONS TO JHU
UNDER PARAGRAPHS 1.12.1(A), 1.12.1(B)I, AND 1.12.1(B)III,

 

and the ANNUAL LICENSE FEE shall be deemed amended accordingly.

 

Anything herein to the contrary notwithstanding, if the events giving rise to
the adjustments to the ANNUAL LICENSE FEE pursuant to this Paragraph 3.4 occur
or arise during any given calendar year, as opposed to at the end of the
calendar year, then the adjustment and the application thereof will be
appropriately and equitably apportioned as between the period of the calendar
year prior to the occurrence (as to which period the ANNUAL LICENSE FEE as
applicable prior to the occurrence will apply) and the period subsequent to the
occurrence (as to which period the ANNUAL LICENSE FEE as so adjusted will
apply), in order to assure an equitable result and application of the ANNUAL
LICENSE FEE and all adjustments thereto.

 

For the avoidance of confusion, and by way of example only, should more than one
permanent injunction issue at different times relating to different JHU
TECHNOLOGIES, JHU shall not be entitled to payment pursuant to Paragraphs
3.4(b)(i) or 3.4(c)(i), above, in an amount exceeding [********] in the
aggregate.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

12

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3.5          FORM OF PAYMENT.  ALL PAYMENTS UNDER THIS AGREEMENT SHALL BE MADE
IN U.S.  DOLLARS.  CHECKS ARE TO BE MADE PAYABLE TO “THE JOHNS HOPKINS
UNIVERSITY”.  WIRE TRANSFERS MAY BE MADE THROUGH:

 

[********]

 

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

 

3.6          LATE PAYMENTS.  IN THE EVENT THAT THE COMPANY FAILS TO MAKE ANY
PAYMENT DUE HEREUNDER WITHIN THIRTY (30) DAYS AFTER THE RELEVANT DUE DATE,
INTEREST SHALL ACCRUE UNDER THIS PARAGRAPH 3.6 AT THE ANNUAL RATE OF THE SUM OF
(A) [********] PLUS (B) [********], PROVIDED HOWEVER, THAT IN NO EVENT SHALL
SAID ANNUAL INTEREST RATE EXCEED THE MAXIMUM LEGAL INTEREST RATE FOR
CORPORATIONS.  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 INCLUDING,
BUT NOT LIMITED TO TERMINATION OF THIS AGREEMENT AS SET FORTH IN PARAGRAPH 9.2
BELOW.

 

3.7          NO MULTIPLE ROYALTIES.  NO MULTIPLE ROYALTIES SHALL BE PAYABLE
BECAUSE ANY FECAL BASED TEST OR OTHER ITEM IS COVERED BY MORE THAN ONE VALID
CLAIM OF THE PATENT RIGHTS.  FOR THE AVOIDANCE OF CONFUSION, AND BY WAY OF
EXAMPLE, IF EXACT’S SUBLICENSEE IS SELLING A FECAL BASED TEST AS A PRODUCT FOR
WHICH COMPANY IS OBLIGATED TO PAY JHU [********] OF COMPANY ROYALTIES, AND JHU
SUBSEQUENTLY LICENSES ADDITIONAL TECHNOLOGY (THE “NEW TECHNOLOGY”) TO COMPANY
PURSUANT TO THIS AGREEMENT, COMPANY SHALL BE FREE TO SUBLICENSE THE NEW
TECHNOLOGY TO SUBLICENSEE FOR USE IN CONNECTION WITH THE FECAL BASED TEST SOLD
AS A PRODUCT WITH COMPANY’S PAYMENT OBLIGATION TO JHU REMAINING AT [********] OF
TOTAL COMPANY ROYALTIES RELATED TO SUBLICENSEE’S FECAL BASED TEST PRODUCT
SALES.  ADDITIONALLY, IN NO EVENT SHALL REVENUE THAT IS RECEIVED BY COMPANY FOR
A FECAL BASED TEST OR OTHER ITEM THAT IS PERFORMED FOR RESEARCH PURPOSES BE
INCLUDED IN THE ANNUAL LICENSE FEE.

 

Additionally, under no circumstances shall multiple royalties be applied:

 

(i)            where EXACT generates COMPANY ROYALTIES relating to a
SUBLICENSEE’S sale of a PRODUCT and said SUBLICENSEE sells the PRODUCT to
another SUBLICENSEE for that SUBLICENSEE’s use of the PRODUCT in connection with
a FECAL BASED TEST offered as a SERVICE.  Under such circumstances, EXACT shall
be obligated to pay JHU the greater of the amounts described in subsections
1.12.1(b)(i)3 and 4 above, and, as applicable, the greater of the amounts
described in subsections 1.12.2(b)(i)3 and 4, rather than such subsections being
additive.

 

(ii)           where EXACT generates COMPANY SALES relating to EXACT’s PRODUCT
sale to a SUBLICENSEE for the SUBLICENSEE’s use of the PRODUCT in connection
with a FECAL BASED TEST offered as a SERVICE.  Under such circumstances, EXACT
shall be obligated to pay JHU the greater of the amounts described in
subsections 1.12.1(b)(i)1 and 4 above, and, as applicable, the greater of the
amounts described in subsections 1.12.2(b)(i)1 and 4, rather than such
subsections being additive.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

13

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3.8          THIRD PARTY ROYALTIES.  IN THE EVENT THAT, AFTER THE EFFECTIVE
DATE, COMPANY OR SUBLICENSEE, IS REQUIRED TO MAKE PAYMENT OF ROYALTIES TO
NON-AFFILIATES IN ORDER TO OBTAIN A LICENSE OR SIMILAR RIGHTS FROM SUCH
NON-AFFILIATES, IN THE ABSENCE OF WHICH LICENSE OR RIGHTS THE COMPANY COULD NOT
PRACTICE UNDER THE PATENT RIGHTS, AND WHICH RIGHTS ARE (IN THE REASONABLE
OPINION OF COMPANY’S OR SUBLICENSEE’S COUNSEL) NECESSARY IN ORDER FOR THE
COMPANY OR SUBLICENSEE TO SELL OR PERFORM INFRINGING FECAL BASED TESTS OR OTHER
ITEMS, THEN [********] OF THE AMOUNT OF ANY SUCH THIRD PARTY PAYMENTS SHALL BE
CREDITED AGAINST AMOUNTS OTHERWISE PAYABLE TO JHU HEREUNDER (ONLY IN SUCH
CIRCUMSTANCES WHERE COMPANY COULD NOT PRACTICE THE PATENT RIGHTS); PROVIDED,
HOWEVER, THAT IN NO EVENT SHALL ANY SUCH CREDIT BE APPLIED TO REDUCE THE AMOUNT
PAYABLE HEREUNDER IN RESPECT OF ANY SUCH INFRINGING FECAL BASED TEST OR OTHER
ITEM TO LESS THAN [********] OF THAT AMOUNT WHICH WOULD OTHERWISE HAVE BEEN PAID
OR PAYABLE TO JHU IN RESPECT THEREOF IN ACCORDANCE WITH THE TERMS OF THIS
AGREEMENT AND PRIOR TO ANY CREDIT OTHERWISE AVAILABLE UNDER THIS PARAGRAPH 3.8.

 

ARTICLE 4          
PATENT PROSECUTION

 

4.1          PROSECUTION & MAINTENANCE - GENERAL.  SUBJECT TO AND IN ACCORDANCE
WITH THE TERMS AND CONDITIONS OF THIS AGREEMENT, INCLUDING THIS ARTICLE 4, THE
PARTIES SHALL PREPARE, FILE, PROSECUTE AND MAINTAIN THE PATENT RIGHTS.  TITLE TO
ALL PATENT AND PATENT APPLICATIONS CONSTITUTING OR COMPRISING THE PATENT RIGHTS
SHALL IN ANY EVENT RESIDE WITH JHU, BUT SHALL CONTINUE TO BE LICENSED TO THE
COMPANY AS AND TO THE EXTENT HEREIN PROVIDED.  PURSUANT TO THE PROVISIONS OF
THIS ARTICLE 4, THE PARTIES DESIRE TO ESTABLISH REASONABLE AND APPROPRIATE
PROCEDURES FOR THE MAKING OF ANY AND ALL DETERMINATIONS NECESSARY IN RESPECT OF
THE PREPARATION, FILING, PROSECUTING AND MAINTAINING OF THE PATENT RIGHTS, AND
FOR THE MAKING OF DECISIONS WITH RESPECT THERETO.  IN THAT REGARD, THE PARTIES
SHALL EXERCISE BEST EFFORTS TO KEEP EACH OTHER INFORMED ON THE PROGRESS OF ALL
PATENTS AND PATENT APPLICATIONS RELATED TO THE PATENT RIGHTS FOR WHICH THE
RESPECTIVE PARTIES MAINTAIN RESPONSIBILITY UNDER THIS AGREEMENT, AS HEREIN BELOW
PROVIDED.  AT ALL TIMES DURING WHICH THIS AGREEMENT REMAINS IN EFFECT, ALL COSTS
AND EXPENSES INCURRED IN CONNECTION WITH THE PROSECUTION, FILING OR MAINTENANCE
OF THE PATENT RIGHTS, INCLUDING COSTS AND EXPENSES OF COUNSEL EMPLOYED BY EXACT
OR JHU IN RESPECT OF EITHER THE EXACT OVERSEEN PATENT RIGHTS OR THE JHU OVERSEEN
PATENT RIGHTS, WHETHER IN A PRIMARY OR OVERSIGHT ROLE AS DESCRIBED FURTHER
BELOW, SHALL BE BORNE SOLELY BY EXACT, AND EXACT SHALL PROMPTLY REIMBURSE JHU
FOR ANY EXPENSES INCURRED AND PAID OUT-OF-POCKET BY JHU IN RESPECT THEREOF.

 

4.2          PROSECUTION, MAINTENANCE — EXACT OVERSEEN PATENT RIGHTS.  FOLLOWING
THE EFFECTIVE DATE, EXACT SHALL, AT ITS SOLE COST AND EXPENSE, BE PRIMARILY
RESPONSIBLE FOR DECISIONS RELATING TO, AND OVERSIGHT AND MANAGEMENT OF, THE
PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF THE EXACT OVERSEEN PATENT
RIGHTS, INCLUDING, WITHOUT LIMITATION, THE SELECTION AND RETENTION OF PATENT
COUNSEL TO PREPARE, FILE, PROSECUTE AND MAINTAIN THE EXACT OVERSEEN PATENT
RIGHTS, ALL SUBJECT, HOWEVER, TO THE TERMS AND CONDITIONS OF THIS ARTICLE 4. 
EXACT SHALL EXERCISE ITS BEST EFFORTS TO KEEP JHU INFORMED OF THE PROGRESS OF
ALL PATENTS AND PATENT APPLICATIONS INCLUDED AMONG THE EXACT OVERSEEN PATENT
RIGHTS, AND IN ANY EVENT, BEFORE TAKING OR AUTHORIZING OR ALLOWING THE TAKING OF
ANY MATERIAL ACTION

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

14

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(VERBALLY, ORALLY OR OTHERWISE) WITH RESPECT TO THE EXACT OVERSEEN PATENT RIGHTS
WITH THE UNITED STATES PATENT AND TRADEMARK OFFICE OR ANY FOREIGN EQUIVALENTS
THEREOF, OR OTHERWISE, EXACT WILL, AND WILL CAUSE ITS PATENT COUNSEL TO,
DISCLOSE TO JHU AND ITS DESIGNATED PATENT COUNSEL, IN REASONABLE DETAIL, THE
ACTION OR ACTIONS SO PROPOSED AND WILL PROVIDE JHU, FOR A PERIOD OF THIRTY (30)
DAYS (THE “REVIEW PERIOD”), WITH REASONABLE OPPORTUNITY TO PROVIDE COMMENT TO
COMPANY, AND TO OTHERWISE DISCUSS WITH COMPANY THE SELECTION AND/OR THE CONTENT
AND SCOPE OF CLAIMS, PATENT FILINGS, PATENT STRATEGY AND OTHER MATTERS
REASONABLY RELATED TO THE ACTION OR ACTIONS PROPOSED TO BE TAKEN.  EXACT AGREES
THAT IT WILL COOPERATE WITH JHU DURING THE REVIEW PERIOD AND ALLOW JHU AND ITS
REPRESENTATIVES AND JHU’S OWN PATENT COUNSEL TO PROVIDE ITS OR THEIR INSIGHT,
OPINION, VIEWS AND POSITIONS TO COMPANY AND COMPANY’ S PATENT COUNSEL DURING THE
REVIEW PERIOD, AND ANY AND ALL BASES THEREFOR AND THAT EXACT WILL, AND WILL
CAUSE ITS PATENT COUNSEL TO, REASONABLY AND APPROPRIATELY CONSIDER AND ENGAGE IN
MEANINGFUL DIALOGUE WITH JHU AND ITS DESIGNATED PATENT COUNSEL DURING THE REVIEW
PERIOD REGARDING THE SAME, BEFORE MAKING ANY FINAL DECISION IN RESPECT OF THE
ACTION OR ACTIONS PROPOSED.  EXACT AGREES THAT IT WILL, IF COMPANY DEEMS IT
REASONABLE AND APPROPRIATE, INCORPORATE JHU’S REASONABLE AND APPROPRIATE
COMMENTS INTO PATENT FILINGS AND, IF COMPANY DEEMS IT REASONABLE AND
APPROPRIATE, ACCEPT JHU’S REASONABLE REQUESTS OR SUGGESTIONS OR EMPLOY JHU’S
REASONABLY RECOMMENDED PROSECUTION STRATEGY, AS RESPECTS THE EXACT OVERSEEN
PATENT RIGHTS, UNLESS IN EITHER CASE EXACT DETERMINES, AFTER CONSIDERATION OF
THE POSITIONS DISCUSSED AND RAISED BY JHU DURING THE REVIEW PERIOD, THAT SO
DOING WOULD, IN EXACT’S REASONABLE OPINION, BE MATERIALLY INCONSISTENT WITH
EXACT’S BUSINESS STRATEGY OR OBJECTIVES, IN WHICH CASE EXACT SHALL, FOLLOWING
THE REVIEW PERIOD, MAKE WHATEVER DECISIONS, AND TAKE WHATEVER ACTIONS, COMPANY
DEEMS APPROPRIATE WITH RESPECT TO THE EXACT OVERSEEN PATENT RIGHTS; PROVIDED,
HOWEVER, BEFORE PROCEEDING FURTHER AND IN A MANNER INCONSISTENT WITH THE
POSITIONS VOICED BY JHU OR ITS PATENT COUNSEL, EXACT AGREES TO, AND TO CAUSE ITS
PATENT COUNSEL TO, ENGAGE IN AN ADDITIONAL THIRTY (30) DAY PERIOD OF DISCUSSION
AND NEGOTIATION (THE “SUBSEQUENT REVIEW PERIOD”) WITH JHU AND ITS PATENT COUNSEL
IN AN EFFORT TO RESOLVE THE DIFFERENCES THEN EXISTING AS BETWEEN THE PARTIES
WITH RESPECT TO THE EXACT OVERSEEN PATENT RIGHTS AND THE ACTION OR ACTIONS SO
PROPOSED.  IF, AFTER NEGOTIATING WITH DILIGENCE AND IN GOOD FAITH DURING THE
SUBSEQUENT REVIEW PERIOD, THE PARTIES STILL CANNOT AGREE OR COME TO SOME
REASONABLE CONSENSUS OR COMPROMISE AS TO THE THEIR DIFFERENCES, THEN, WITH
RESPECT TO THE EXACT OVERSEEN PATENT RIGHTS, EXACT SHALL BE FREE TO MAKE THE
ULTIMATE DECISION(S) AS TO THE ACTION OR ACTIONS TO BE TAKEN, AND TO TAKE SUCH
ACTION(S), WITH RESPECT TO THE EXACT OVERSEEN PATENT RIGHTS AND JHU SHALL
COOPERATE AND LEND REASONABLE ASSISTANCE TO COMPANY WITH RESPECT THERETO.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

15

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4.3          PROSECUTION, MAINTENANCE — JHU OVERSEEN PATENT RIGHTS.  FOLLOWING
THE EFFECTIVE DATE, JHU SHALL BE PRIMARILY RESPONSIBLE FOR DECISIONS RELATING
TO, AND OVERSIGHT AND MANAGEMENT OF THE PREPARATION, FILING, PROSECUTION AND
MAINTENANCE OF THE JHU OVERSEEN PATENT RIGHTS, INCLUDING, WITHOUT LIMITATION,
THE SELECTION AND RETENTION OF PATENT COUNSEL TO PREPARE, FILE, PROSECUTE AND
MAINTAIN THE JHU OVERSEEN PATENT RIGHTS, ALL SUBJECT, HOWEVER, TO THE TERMS AND
CONDITIONS OF THIS ARTICLE 4.  JHU SHALL EXERCISE ITS BEST EFFORTS TO KEEP EXACT
INFORMED OF THE PROGRESS OF ALL PATENTS AND PATENT APPLICATIONS INCLUDED AMONG
THE JHU OVERSEEN PATENT RIGHTS, AND IN ANY EVENT, BEFORE TAKING OR AUTHORIZING
THE TAKING OF ANY MATERIAL ACTION (VERBALLY, ORALLY OR OTHERWISE) WITH RESPECT
TO THE JHU OVERSEEN PATENT RIGHTS WITH THE UNITED STATES PATENT AND TRADEMARK
OFFICE OR ANY FOREIGN EQUIVALENTS THEREOF, OR OTHERWISE, JHU WILL, AND WILL
CAUSE ITS PATENT COUNSEL TO, DISCLOSE TO EXACT AND ITS PATENT COUNSEL, IN
REASONABLE DETAIL, THE ACTION OR ACTIONS SO PROPOSED AND WILL PROVIDE EXACT, FOR
A PERIOD OF THIRTY (30) DAYS (THE “REVIEW PERIOD”), WITH REASONABLE OPPORTUNITY
PROVIDED, TO PROVIDE COMMENT TO JHU AND TO OTHERWISE DISCUSS WITH JHU THE
SELECTION AND/OR THE CONTENT AND SCOPE OF CLAIMS, PATENT FILINGS, PATENT
STRATEGY AND OTHER MATTERS REASONABLY RELATED TO THE ACTION OR ACTIONS PROPOSED
TO BE TAKEN.  JHU AGREES THAT IT WILL COOPERATE WITH EXACT DURING THE REVIEW
PERIOD AND ALLOW EXACT AND ITS REPRESENTATIVES AND EXACT’S OWN PATENT COUNSEL TO
PROVIDE ITS OR THEIR INSIGHT, OPINION, VIEWS AND POSITIONS TO JHU AND JHU’S
PATENT COUNSEL DURING THE REVIEW PERIOD, AND ANY AND ALL BASES THEREFOR, AND
THAT JHU WILL, AND WILL CAUSE ITS PATENT COUNSEL TO, REASONABLY AND
APPROPRIATELY CONSIDER AND ENGAGE IN MEANINGFUL DIALOGUE WITH EXACT AND ITS
DESIGNATED PATENT COUNSEL DURING THE REVIEW PERIOD REGARDING THE SAME BEFORE
MAKING ANY FINAL DECISION IN RESPECT OF THE ACTION OR ACTIONS PROPOSED.  JHU
AGREES THAT IT WILL, IF JHU DEEMS IT REASONABLE AND APPROPRIATE, INCORPORATE
EXACT’S REASONABLE AND APPROPRIATE COMMENTS INTO PATENT FILINGS AND, IF JHU
DEEMS IT REASONABLE AND APPROPRIATE, ACCEPT EXACT’S REASONABLE REQUESTS OR
SUGGESTIONS OR EMPLOY EXACT’S REASONABLY RECOMMENDED PROSECUTION STRATEGY, AS
RESPECTS THE JHU OVERSEEN PATENT RIGHTS, UNLESS JHU DETERMINES, AFTER
CONSIDERATION OF THE POSITIONS DISCUSSED AND RAISED BY EXACT DURING THE REVIEW
PERIOD, THAT SO DOING WOULD , OR COULD BE LIKELY TO IN JHU’S REASONABLE OPINION,
BE MATERIALLY INCONSISTENT WITH JHU’S COMMERCIALIZATION STRATEGY OR POLICY OR
MISSION, IN WHICH CASE JHU SHALL, FOLLOWING THE REVIEW PERIOD, MAKE WHATEVER
DECISIONS, AND TAKE WHATEVER ACTIONS, JHU DEEMS APPROPRIATE WITH RESPECT TO THE
JHU OVERSEEN PATENT RIGHTS; PROVIDED, HOWEVER, BEFORE PROCEEDING FURTHER AND IN
A MANNER INCONSISTENT WITH THE POSITIONS VOICED BY EXACT OR ITS PATENT COUNSEL,
JHU AGREES TO, AND TO CAUSE ITS PATENT COUNSEL TO, ENGAGE IN AN ADDITIONAL
THIRTY (30) DAY PERIOD OF DISCUSSION AND NEGOTIATION (THE “SUBSEQUENT REVIEW
PERIOD”) WITH EXACT AND ITS PATENT COUNSEL IN AN EFFORT TO RESOLVE THE
DIFFERENCES THEN EXISTING AS BETWEEN THE PARTIES WITH RESPECT TO THE JHU
OVERSEEN PATENT RIGHTS AND THE ACTION OR ACTIONS SO PROPOSED.  IF, AFTER
NEGOTIATING WITH DILIGENCE AND IN GOOD FAITH DURING THE SUBSEQUENT REVIEW
PERIOD, THE PARTIES STILL CANNOT AGREE OR COME TO SOME REASONABLE CONSENSUS OR
COMPROMISE AS TO THE THEIR DIFFERENCES, THEN, WITH RESPECT TO THE JHU OVERSEEN
PATENT RIGHTS, JHU SHALL BE FREE TO MAKE THE ULTIMATE DECISION(S) AS TO THE
ACTION OR ACTIONS TO BE TAKEN, AND TO TAKE SUCH ACTION(S), WITH RESPECT TO THE
JHU OVERSEEN PATENT RIGHTS AND EXACT SHALL COOPERATE AND LEND REASONABLE
ASSISTANCE TO JHU WITH RESPECT THERETO.  FOR THE AVOIDANCE OF DOUBT, WHILE THIS
AGREEMENT REMAINS IN EFFECT, EXACT SHALL BE RESPONSIBLE FOR ALL COSTS AND
EXPENSES OF JHU’S PATENT COUNSEL, AND ANY OTHER AMOUNTS OR EXPENSES ASSOCIATED
WITH THE PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF ANY PATENT
APPLICATIONS OR PATENTS INCLUDED AMONG THE JHU OVERSEEN PATENT RIGHTS.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

16

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4.4          ELECTION NOT TO PROSECUTE OR MAINTAIN.  EXACT MAY ELECT NOT TO
PREPARE, FILE, PROSECUTE OR MAINTAIN A PATENT OR PATENT APPLICATION UNDER THE
EXACT OVERSEEN PATENT RIGHTS BY PROVIDING WRITTEN NOTICE TO JHU.  UPON SUCH
NOTIFICATION BY EXACT, WHICH SHALL BE IRREVOCABLE WITH RESPECT TO THE SCOPE OF
THE ELECTION, JHU MAY, AT ITS SOLE DISCRETION, ASSUME RESPONSIBILITY FOR THE
PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF THE SPECIFIC PATENT OR
PATENT APPLICATIONS REFERENCED IN EXACT’S NOTICE TO JHU, WITHOUT REGARD TO THE
PROCEDURES SET FORTH IN PARAGRAPH 4.3 ABOVE, AND JHU SHALL PROVIDE EXACT WITH
PROMPT WRITTEN NOTIFICATION OF SUCH ASSUMPTION.  ANY PATENT OR PATENT
APPLICATION FOR WHICH JHU ASSUMES RESPONSIBILITY UNDER THIS PARAGRAPH 4.4 SHALL
NOT REMAIN PART OF THE PATENT RIGHTS HEREUNDER.  EXACT SHALL NOT BE RESPONSIBLE
FOR ANY COSTS AND EXPENSES OF JHU’S PATENT COUNSEL OR ANY OTHER AMOUNTS OR
EXPENSES ASSOCIATED WITH THE PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF
ANY PATENT APPLICATIONS OR PATENTS, ON A THEN GOING FORWARD BASIS FOR WHICH
EXACT ELECTS NOT TO PREPARE, FILE, PROSECUTE OR MAINTAIN OR FOR WHICH JHU
ASSUMES RESPONSIBILITY UNDER THIS PARAGRAPH.

 

4.5          INFRINGEMENT NOTIFICATION.  IF EITHER PARTY BECOMES AWARE THAT A
THIRD PARTY MAY BE INFRINGING OR THREATENING TO INFRINGE ANY OF THE PATENTS
UNDER THE PATENT RIGHTS, THAT PARTY SHALL PROVIDE PROMPT WRITTEN NOTIFICATION OF
SUCH INFRINGEMENT OR THREAT TO THE OTHER PARTY (THE “INFRINGEMENT
NOTIFICATION”).

 

4.6          INFRINGEMENT.  EXCEPT AS SPECIFICALLY PROVIDED OTHERWISE UNDER THIS
PARAGRAPH 4.6, COMPANY SHALL INITIALLY HAVE THE SOLE AND EXCLUSIVE RIGHT, BUT
NOT THE OBLIGATION TO INITIATE AND CARRY ON LEGAL PROCEEDINGS, AT COMPANY’S SOLE
EXPENSE AND IN JHU’S AND HHMI’S NAME, IF SO REQUIRED BY LAW, AGAINST ANY
INFRINGER OR ALLEGED INFRINGER OF ANY PATENT OR PATENT APPLICATION WITHIN PATENT
RIGHTS.  SUCH RIGHT SHALL INCLUDE THE RIGHT TO BRING SUIT AND COLLECT DAMAGES
FOR PAST INFRINGEMENT OF ANY PATENT WITHIN THE PATENT RIGHTS.  COMPANY SHALL
CONTROL ALL ASPECTS OF ANY SUCH PROCEEDING, INCLUDING, WITHOUT LIMITATION, THE
STRATEGY, DEFENSE, AND SETTLEMENT OF SUCH PROCEEDING, AND SHALL DO SO IN A
MANNER CONSISTENT WITH THE TERMS AND PROVISIONS HEREOF.  SUBJECT TO PARAGRAPH
4.8, ANY DAMAGE, COST, AWARD, FEE, RECOVERY, OR COMPENSATION PAID BY ANY THIRD
PARTY IN CONNECTION WITH ANY PROCEEDING INITIATED OR CARRIED ON AT COMPANY’S
EXPENSE (WHETHER BY WAY OF SETTLEMENT OR OTHERWISE) SHALL BE RETAINED BY THE
COMPANY.  THE COMPANY SHALL NOT ENTER INTO ANY SETTLEMENT, CONSENT JUDGMENT, OR
ANY OTHER VOLUNTARY FINAL DISPOSITION OF ANY INFRINGEMENT ACTION UNDER THIS
PARAGRAPH 4.6 WITHOUT THE PRIOR WRITTEN CONSENT OF JHU, WHICH SHALL NOT BE
UNREASONABLY WITHHELD, CONDITIONED OR DELAYED.  COMPANY’S RIGHT TO SUE FOR
INFRINGEMENT HEREUNDER SHALL NOT BE USED IN AN ARBITRARY OR CAPRICIOUS MANNER.

 

If COMPANY elects not to enforce any patent within the PATENT RIGHTS, then it
shall so notify JHU in writing within ninety (90) days of EXACT’s receipt of a
notice of infringement pursuant to Paragraph 4.5, whereupon the right to
initiate and carry on legal proceedings in respect of the particular
infringement shall then vest solely in JHU, and JHU may, in its sole judgment
and at its own expense, in Company’s or its AFFILIATES name if so required by
law, initiate and carry on legal proceedings to enforce any patent and control,
settle, and defend such proceeding in a manner consistent with the terms and
provisions hereof, and recover, for its own account, any damages, awards or
settlements resulting therefrom.  JHU shall not enter into any settlement,
consent judgment, or any other voluntary final disposition of any infringement
action under this Paragraph 4.6 without the prior written consent of the

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

17

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COMPANY, which shall not be unreasonably withheld, conditioned or delayed. 
JHU’s right to sue for infringement hereunder shall not be used in an arbitrary
or capricious manner.

 

4.7          COOPERATION.  IN THE EVENT THAT EITHER PARTY DESIRES TO INITIATE,
INITIATES, OR CARRIES ON ANY LEGAL PROCEEDINGS UNDER PARAGRAPH 4.6 TO ENFORCE OR
PROTECT ANY PATENT UNDER THE PATENT RIGHTS, THE OTHER PARTY SHALL FULLY
COOPERATE WITH AND SHALL SUPPLY ALL ASSISTANCE REASONABLY REQUIRED BY THE
INITIATING PARTY.  TO THAT END, EACH PARTY WAIVES ALL OF ITS RIGHTS TO OPPOSE
JOINDER AS A PARTY TO ANY LEGAL ACTION INITIATED OR CARRIED ON PURSUANT TO
PARAGRAPH 4.6 IN WHICH THE OTHER IS A NAMED PARTY.  IN ANY EVENT, ANY PARTY
INITIATING OR CARRYING ON ANY SUCH LEGAL PROCEEDINGS UNDER PARAGRAPH 4.6 (THE
“INITIATING PARTY”) SHALL HAVE SOLE CONTROL OF THE ACTION AND SHALL BEAR
REASONABLE EXPENSES (EXCLUDING LEGAL FEES) INCURRED BY THE OTHER PARTY (THE
“NON-INITIATING PARTY”) IN COOPERATING WITH OR PROVIDING ANY ASSISTANCE TO THE
INITIATING PARTY.  THE NON-INITIATING PARTY SHALL HAVE THE RIGHT TO PARTICIPATE
IN ANY ACTIONS INITIATED OR CARRIED ON BY THE INITIATING PARTY WITH COUNSEL
SELECTED BY IT, BUT AT ITS OWN EXPENSE.  THE INITIATING PARTY SHALL, AT ALL
TIMES, KEEP THE NON-INITIATING PARTY REASONABLY INFORMED OF THE STATUS OF ANY
ACTION TAKEN UNDER PARAGRAPH 4.6.

 

4.8          RECOVERY.  ANY RECOVERY BY COMPANY, LESS ALL LEGAL FEES AND COSTS,
UNDER PARAGRAPH 4.6 SHALL BE DEEMED TO REFLECT LOSS OF COMMERCIAL SALES, AND
COMPANY SHALL PAY TO JHU [********] OF THE BALANCE OF THE RECOVERY NET OF ALL
REASONABLE COSTS AND EXPENSES ASSOCIATED WITH EACH SUIT OR SETTLEMENT.  IF THE
COST AND EXPENSES EXCEED THE RECOVERY, THEN [********] OF THE EXCESS SHALL BE
CREDITED AGAINST ANNUAL FEES PAYABLE BY COMPANY TO JHU HEREUNDER AND
ATTRIBUTABLE TO SALES IN THE COUNTRY OF SUCH LEGAL PROCEEDINGS, PROVIDED,
HOWEVER, THAT ANY SUCH CREDIT UNDER THIS PARAGRAPH SHALL NOT EXCEED [********]
OF THE ANNUAL FEES OTHERWISE PAYABLE TO JHU WITH REGARD TO SALES IN THE COUNTRY
OF SUCH ACTION IN ANY ONE CALENDAR YEAR, WITH ANY EXCESS CREDIT BEING CARRIED
FORWARD TO FUTURE CALENDAR YEARS.

 

4.9          THIRD PARTY ACTIONS.  IN THE EVENT THAT A THIRD PARTY (A) COMMENCES
LEGAL ACTION AGAINST EXACT, ITS AFFILIATES OR ITS SUBLICENSEE(S) RELATING TO THE
PATENT RIGHTS, OR (B) SEEKS TO ENJOIN EXACT, ITS AFFILIATES OR ITS SUBLICENSEES
FROM MAKING, SELLING, PERFORMING, USING, OR OTHERWISE COMMERCIALIZING IN ANY
WAY, AN INFRINGING FECAL BASED TEST OR OTHER ITEM, (A.  AND B.  ABOVE SHALL BE
REFERRED TO HEREIN AS THE “LEGAL ACTION”), COMPANY SHALL BE OBLIGATED TO
VIGOROUSLY DEFEND THE LEGAL ACTION UNTIL THE SOONER OF (I) COMPANY INCURS
[********] IN LEGAL FEES AND/OR EXPENSES (THE “DEFENSE COSTS”) (INCLUDING, BUT
NOT LIMITED TO, SETTLEMENT AMOUNTS, JUDGMENTS, DAMAGE AWARDS, ETC.),
(II) NOTWITHSTANDING ITS VIGOROUS AND REASONABLE DEFENSE (I.E.  “REASONABLE”
GIVEN THE TIME AVAILABLE TO MOUNT SUCH A DEFENSE PRIOR TO INJUNCTION ISSUANCE),
COMPANY AND ITS AFFILIATED COMPANIES AND SUBLICENSEES ARE PERMANENTLY ENJOINED
(AND ALL RIGHTS OF APPEAL HAVE EXPIRED OR BEEN EXHAUSTED) IN THE UNITED STATES
FROM SELLING ALL SUCH PRODUCTS AND PERFORMING ALL SUCH SERVICES THAT COMPANY,
ANY AFFILIATED COMPANY OR SUBLICENSEE WERE SELLING OR PROVIDING PRIOR TO
ISSUANCE OF THE INJUNCTION, OR (III) JHU PROVIDES WRITTEN NOTICE TO COMPANY,
AUTHORIZING THE COMPANY TO CEASE DEFENDING THE LEGAL ACTION (ALTHOUGH, FOLLOWING
RECEIPT OF SUCH NOTICE FROM JHU, COMPANY SHALL BE ENTITLED (THOUGH NOT
OBLIGATED) TO CONTINUE DEFENDING THE LEGAL ACTION AT COMPANY’S SOLE COST AND
EXPENSE).  NOTWITHSTANDING THE FOREGOING, ALL AMOUNTS INCURRED BY COMPANY
RELATING TO THE DEFENSE COSTS, UP TO BUT NOT EXCEEDING THE [********] AMOUNT,
WILL BE APPLIED AGAINST THE

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

18

--------------------------------------------------------------------------------

 

CUMULATIVE CAP AS DESCRIBED IN PARAGRAPH 3.4 ABOVE.  ANY RECOVERY OF DAMAGES BY
COMPANY FOR EACH SUCH SUIT SHALL BE APPLIED FIRST IN SATISFACTION OF ANY
UNREIMBURSED DEFENSE COSTS OF COMPANY RELATING TO SUCH LEGAL ACTION (AND WHICH
SHALL BE APPLIED TO REINSTATE THE CUMULATIVE CAP BY AN EQUIVALENT AMOUNT) AND
NEXT TOWARD REIMBURSEMENT OF JHU FOR ANY ANNUAL FEE AMOUNTS TO WHICH JHU WOULD
BE ENTITLED UNDER PARAGRAPH 3.4 OF THIS AGREEMENT.

 

4.10        SUBLICENSE OF INFRINGERS.  COMPANY SHALL DURING THE TERM OF THIS
AGREEMENT HAVE THE SOLE RIGHT SUBJECT TO THE TERMS AND CONDITIONS HEREOF TO
SUBLICENSE ANY ALLEGED INFRINGER UNDER THE PATENT RIGHTS, SUBJECT, HOWEVER, TO
THE PROVISIONS OF PARAGRAPH 2.2 HEREOF.

 

4.11        CURRENT PATENT EXPENSES.  WITHIN THIRTY (30) DAYS AFTER THE
EXECUTION OF THIS AGREEMENT, EXACT WILL MAKE PAYMENT TO JHU IN THE AMOUNT OF
TWENTY-THOUSAND DOLLARS ($20,000.00) FOR ALL PREVIOUSLY UNREIMBURSED COSTS AND
EXPENSES INCURRED BY JHU ON OR PRIOR TO THE EFFECTIVE DATE IN CONNECTION WITH
THE PROSECUTION, FILING OR MAINTENANCE OF THE PATENT RIGHTS.

 

ARTICLE 5
OBLIGATIONS OF THE PARTIES

 

5.1          REPORTS.  COMPANY SHALL PROVIDE TO JHU WITHIN THIRTY (30) DAYS
AFTER THE END OF EACH MARCH 31ST, JUNE 30TH, SEPTEMBER 30TH AND DECEMBER 31ST
FOLLOWING THE EFFECTIVE DATE OF THIS AGREEMENT, A WRITTEN REPORT AS RESPECTS THE
PRECEDING THREE (3) MONTH PERIOD PROVIDING DETAIL REASONABLY SATISFACTORY TO JHU
TO CAPTURE THE AMOUNTS DUE JHU HEREUNDER.  JHU AND COMPANY WILL WORK TOGETHER TO
PUT IN PLACE A REPORTING STRUCTURE THAT IS MUTUALLY ACCEPTABLE TO THE PARTIES
AND EACH PARTY AGREES TO WORK WITH THE OTHER TO MODIFY THE REPORTING STRUCTURE,
FROM TIME TO TIME, AS NECESSARY TO BETTER MEET THE REPORTING REQUIREMENTS OF THE
PARTIES HEREUNDER.

 

In addition, EXACT shall provide such other and additional information, data and
reports as may be reasonably necessary in order to allow for a full
determination by JHU of the sums due and owing to JHU hereunder.

 

5.2          RECORDS.  COMPANY SHALL MAKE AND RETAIN, FOR A PERIOD OF THREE
(3) YEARS FOLLOWING THE PERIOD OF EACH REPORT REQUIRED BY PARAGRAPH 5.1, TRUE
AND ACCURATE RECORDS, FILES AND BOOKS OF ACCOUNT CONTAINING ALL DATA AND
INFORMATION REASONABLY REQUIRED FOR FULL DETERMINATION OF THE INFORMATION
REQUIRED IN PARAGRAPH 5.1 ABOVE.  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 COMPANY. 
ABSENT REASONABLY SUFFICIENT AND ARTICULABLE REASON THEREFOR, 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 COMPANY. 
INSOFAR AS IS NECESSARY TO ALLOW FOR THE DELIVERY TO JHU BY THE COMPANY OF THE
INFORMATION REQUIRED TO BE INCLUDED IN THE REPORTS DESCRIBED IN PARAGRAPH 5.1
ABOVE, COMPANY SHALL REQUIRE OF ITS AFFILIATED COMPANIES THAT THEY RETAIN
RECORDS AND PROVIDE TO THE COMPANY ANY AND ALL

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

19

--------------------------------------------------------------------------------

 

SUCH INFORMATION AND DATA, AND THE COMPANY SHALL INCLUDE IN ANY AND ALL
AGREEMENTS WITH SUCH AFFILIATED COMPANIES A PROVISION TO THAT EFFECT AND
ALLOWING FOR THE INSPECTION BY JHU OF SUCH RECORDS.

 

5.3          COMMERCIAL EFFORTS.  COMPANY SHALL EXERCISE COMMERCIALLY REASONABLE
EFFORTS TO DEVELOP AND INTRODUCE FECAL BASED TESTS THAT USE THE PATENT RIGHTS
INTO THE COMMERCIAL MARKET AS SOON AS PRACTICABLE, CONSISTENT WITH SOUND AND
REASONABLE BUSINESS PRACTICE AND JUDGMENT.  COMPANY SHALL ALSO EXERCISE
COMMERCIALLY REASONABLE EFFORTS TO DEVELOP OTHER ITEMS AS SOON AND AS BROADLY AS
PRACTICABLE, CONSISTENT WITH SOUND AND REASONABLE BUSINESS PRACTICE AND
JUDGMENT, THE SOLE REMEDY FOR THE COMPANY’S FAILURE IN SO DOING TO BE
TERMINATION OF THE LICENSE GRANTED HEREON IN A PARTICULAR MARKET AS CONTEMPLATED
BY THE LAST SENTENCE OF PARAGRAPH 5.4 BELOW.

 

5.4          OTHER PRODUCTS.  AFTER JHU PROVIDES COMPANY WITH OBJECTIVE EVIDENCE
(THE “NOTIFICATION”) THAT DEMONSTRATES THE COMMERCIAL PRACTICALITY OF
APPLICATION OF THE PATENT RIGHTS IN A CLEARLY DEFINED PRODUCT OR MARKET SEGMENT
(E.G.  OTHER CANCERS BEYOND COLORECTAL) (THE “MARKET”) WHICH, AS OF THE DATE OF
NOTIFICATION, IS NOT BEING DEVELOPED OR COMMERCIALIZED BY COMPANY, ITS
AFFILIATES OR ITS SUBLICENSEE, COMPANY SHALL EITHER (I) PROVIDE JHU WITH A
REASONABLE DEVELOPMENT PLAN AND START DEVELOPMENT, OR (II) SUBLICENSE THE
PARTICULAR TECHNOLOGY TO A THIRD PARTY, FOR APPLICATION IN THE PARTICULAR
MARKET.  IF WITHIN TWO (2) YEARS AFTER COMPANY’S RECEIPT OF THE NOTIFICATION,
COMPANY HAS NOT (A) INITIATED SUCH DEVELOPMENT EFFORTS, OR (B) SUBLICENSED THE
PARTICULAR MARKET DESCRIBED IN THE NOTIFICATION (WITH SUCH SUBLICENSE AGREEMENT
CONTAINING CONTRACTUAL ASSURANCES THAT THE SUBLICENSEE WILL EXERCISE REASONABLE
EFFORTS TO PURSUE THE PARTICULAR MARKET), THEN JHU MAY TERMINATE THE LICENSE
GRANTED HEREUNDER FOR THE PARTICULAR MARKET.

 

5.5          PATENT ACKNOWLEDGEMENT.  COMPANY AGREES TO MARK ALL APPLICABLE
PRODUCTS OR SERVICES SOLD BY COMPANY WITH THE NUMBER OF THE APPLICABLE
PATENT(S) LICENSED HEREUNDER IN ACCORDANCE WITH EACH COUNTRY’S PATENT LAWS.

 

ARTICLE 6
REPRESENTATIONS

 

6.1          REPRESENTATIONS BY JHU.  JHU WARRANTS THAT IT HAS GOOD AND
MARKETABLE TITLE TO ITS INTEREST IN THE INVENTIONS CLAIMED IN THE PATENT RIGHTS
WITH THE EXCEPTION OF CERTAIN RETAINED RIGHTS OF THE UNITED STATES GOVERNMENT
AND/OR HHMI, BUT DOES NOT WARRANT THE VALIDITY OF ANY PATENTS OR THAT PRACTICE
UNDER SUCH PATENTS SHALL BE FREE OF INFRINGEMENT.  COMPANY AGREES, AND WILL
CAUSE ALL AFFILIATED COMPANIES AND ANY AND ALL SUBLICENSEES TO AGREE FOR THE
BENEFIT OF JHU, AND OTHERS THAT THE PATENT RIGHTS ARE PROVIDED “AS IS”, AND JHU
MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF ANY
PRODUCT OR SERVICE, INCLUDING WITH RESPECT TO SAFETY, EFFECTIVENESS, OR
COMMERCIAL VIABILITY.  JHU DISCLAIMS ALL WARRANTIES WITH REGARD TO THE PATENT
RIGHTS AND WITH REGARD TO ANY AND ALL PRODUCTS, PROCESSES, METHODS OR SERVICES
EMBODYING OR

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

20

--------------------------------------------------------------------------------

 

RELYING UPON THE PATENT RIGHTS, 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, ATTORNEY’S AND EXPERT 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 USE OF THE PATENT RIGHTS OR ANY AND ALL PRODUCTS,
PROCESSES, METHODS OR SERVICES EMBODYING OR RELYING THEREUPON.  COMPANY ASSUMES,
AND WITHOUT LIMITING COMPANY’S OBLIGATIONS HEREUNDER, WILL CAUSE ALL AFFILIATED
COMPANIES AND ANY AND ALL SUBLICENSEES TO ASSUME, ALL RESPONSIBILITY AND
LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT, PROCESS, METHOD OR SERVICE
MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEE OR ANY AFFILIATED
COMPANIES OR EMBODYING OR RELYING UPON THE PATENT RIGHTS WHICH ARE THE SUBJECT
OF THIS AGREEMENT.

 

ARTICLE 7
INDEMNIFICATION

 

7.1          INDEMNIFICATION.  JHU AND THE INVENTORS WILL NOT, UNDER ANY OF THE
PROVISIONS OF THIS AGREEMENT, OR OTHERWISE, HAVE CONTROL OVER THE MANNER IN
WHICH COMPANY, OR ITS AFFILIATED COMPANIES OR ITS SUBLICENSEES, OR THOSE
OPERATING FOR ITS ACCOUNT, OR THIRD PARTIES WHO PURCHASE FECAL BASED TESTS OR
OTHER ITEMS FROM ANY OF THE FOREGOING ENTITIES, PRACTICE THE INVENTIONS OF THE
PATENT RIGHTS LICENSED HEREUNDER, OR PRACTICE OR MAKE USE OF THE FECAL BASED
TESTS OR OTHER ITEMS.  COMPANY AND ITS AFFILIATES SHALL, AND COMPANY SHALL CAUSE
ITS SUBLICENSEES AND AFFILIATES WHO OBTAIN ANY RIGHT OR INTEREST IN RESPECT OF
THE PATENT RIGHTS TO, DEFEND AND HOLD JHU, THE JOHNS HOPKINS HEALTH
SYSTEMS, INC., HHMI, THEIR PRESENT AND FORMER TRUSTEES, OFFICERS, THE INVENTORS
OF PATENT RIGHTS, AGENTS, FACULTY, EMPLOYEES AND STUDENTS, HARMLESS AS AGAINST
ANY JUDGMENT, 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 OR ANY PATENT RIGHTS AGAINST ANY
OF THE FOREGOING INDEMNITIES, WHETHER JHU OR SAID INVENTORS, OR OTHER
INDEMNITIES, EITHER JOINTLY OR SEVERALLY, IS OR ARE NAMED AS A PARTY TO ANY SUCH
LAWSUIT.  PRACTICE OF THE INVENTIONS COVERED BY THE PATENT RIGHTS BY AN
AFFILIATED COMPANY OR AGENT OR SUBLICENSEE, OR A THIRD PARTY ON BEHALF OF OR FOR
ACCOUNT OF COMPANY, OR BY A THIRD PARTY WHO PURCHASES ANY PRODUCT OR SERVICE
FROM THE COMPANY, SHALL ALSO BE CONSIDERED THE COMPANY’S PRACTICE OF SAID
INVENTIONS FOR PURPOSES OF THIS PARAGRAPH 7.1.  HHMI AND ITS TRUSTEES, OFFICERS,
EMPLOYEES, AND AGENTS (COLLECTIVELY, “HHMI INDEMNITEES”), WILL BE INDEMNIFIED,
DEFENDED BY COUNSEL ACCEPTABLE TO HHMI, AND HELD HARMLESS BY COMPANY FROM AND
AGAINST ANY CLAIM, LIABILITY, COST, EXPENSE, DAMAGE, DEFICIENCY, LOSS, OR
OBLIGATION, OF ANY KIND OR NATURE (INCLUDING, WITHOUT LIMITATION, REASONABLE
ATTORNEYS’ FEES AND OTHER COSTS AND EXPENSES OF DEFENSE) (COLLECTIVELY,
“CLAIMS”), BASED UPON, ARISING OUT OF, OR OTHERWISE RELATING TO THIS AGREEMENT,
INCLUDING WITHOUT LIMITATION ANY CAUSE OF ACTION RELATING TO PRODUCT LIABILITY. 

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

21

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THE OBLIGATION OF COMPANY TO DEFEND AND INDEMNIFY AS SET OUT IN THIS PARAGRAPH
7.1 SHALL SURVIVE THE TERMINATION OF THIS AGREEMENT.

 

ARTICLE 8
CONFIDENTIALITY

 

8.1          CONFIDENTIALITY.  DURING THE TERM OF THIS AGREEMENT, THE PARTIES
MAY EXCHANGE INFORMATION, WHICH THEY CONSIDER TO BE CONFIDENTIAL.  “CONFIDENTIAL
INFORMATION” HEREUNDER SHALL, SUBJECT TO PARAGRAPH 8.2, MEAN ANY INFORMATION OR
MATERIALS WHICH ARE DISCLOSED BY ONE PARTY (THE “DISCLOSER”) TO THE OTHER PARTY
(THE “RECIPIENT”), WHETHER ORALLY, VISUALLY, OR IN TANGIBLE FORM, AND ALL COPIES
THEREOF.  TANGIBLE MATERIALS THAT DISCLOSE OR EMBODY CONFIDENTIAL INFORMATION
SHALL BE MARKED BY DISCLOSER AS “CONFIDENTIAL”, “PROPRIETARY” OR THE SUBSTANTIAL
EQUIVALENT THEREOF.  CONFIDENTIAL INFORMATION THAT IS DISCLOSED ORALLY OR
VISUALLY SHALL BE IDENTIFIED BY DISCLOSER AS CONFIDENTIAL AT THE TIME OF
DISCLOSURE AND REDUCED TO A WRITTEN SUMMARY BY DISCLOSER, WHICH SHALL MARK SUCH
SUMMARY AS “CONFIDENTIAL”, “PROPRIETARY” OR THE SUBSTANTIAL EQUIVALENT THEREOF,
AND DELIVER IT TO RECIPIENT BY THE END OF THE MONTH FOLLOWING THE MONTH IN WHICH
DISCLOSURE OCCURS.  SUCH INFORMATION SHALL BE TREATED AS CONFIDENTIAL
INFORMATION PENDING RECEIPT OF SUCH SUMMARY.  NOTWITHSTANDING THE FOREGOING,
THIS AGREEMENT AND THE TERMS OF THIS AGREEMENT SHALL BE CONSIDERED CONFIDENTIAL
INFORMATION OF EACH PARTY HERETO (WITH THE EXCEPTION THAT JHU MAY DISCLOSE THE
TERMS OF THIS AGREEMENT IN CONFIDENCE TO HHMI), AND EACH PARTY SHALL BE DEEMED
BOTH A DISCLOSER AND RECIPIENT THEREOF; AND THE REPORTS AND OTHER INFORMATION
DELIVERED PURSUANT TO PARAGRAPHS 5.1 AND/OR 5.2 HEREOF SHALL ALSO BE
CONFIDENTIAL INFORMATION.  THE RECIPIENT SHALL EMPLOY ALL REASONABLE EFFORTS TO
MAINTAIN THE SECRECY AND CONFIDENTIALITY OF CONFIDENTIAL INFORMATION RECEIVED BY
IT, SUCH EFFORTS TO BE NO LESS THAN THE DEGREE OF CARE EMPLOYED BY THE RECIPIENT
TO PRESERVE AND SAFEGUARD ITS OWN CONFIDENTIAL INFORMATION.  THE CONFIDENTIAL
INFORMATION SHALL NOT BE DISCLOSED OR REVEALED TO ANYONE EXCEPT EMPLOYEES OF THE
RECIPIENT WHO HAVE A NEED TO KNOW THE INFORMATION AND WHO HAVE ENTERED INTO A
SECRECY AGREEMENT WITH THE RECIPIENT UNDER WHICH SUCH EMPLOYEES ARE REQUIRED TO
MAINTAIN CONFIDENTIAL THE PROPRIETARY INFORMATION OF THE RECIPIENT AND SUCH
EMPLOYEES SHALL BE ADVISED BY THE RECIPIENT OF THE CONFIDENTIAL NATURE OF THE
INFORMATION AND THAT THE INFORMATION SHALL BE TREATED ACCORDINGLY.

 

8.2          EXCEPTIONS.  THE RECIPIENT MAY DISCLOSE CONFIDENTIAL INFORMATION
ONLY TO THE EXTENT REQUIRED BY LAW (AS REASONABLY DETERMINED BY THE RECIPIENT’S
COUNSEL), GOVERNMENT REGULATION OR COURT ORDER AND AFTER CONSULTATION WITH, AND
THE AGREEMENT OF THE DISCLOSER (WHICH WILL NOT BE UNREASONABLY WITHHELD,
CONDITIONED OR DELAYED).  THE RECIPIENT’S OBLIGATIONS UNDER PARAGRAPH 8.1 SHALL
NOT EXTEND TO ANY PART OF THE INFORMATION:

 

(A)                                  THAT IS DEMONSTRATED TO HAVE BEEN IN THE
PUBLIC DOMAIN OR PUBLICLY KNOWN PRIOR TO THE DATE OF THE DISCLOSURE; OR

 

(B)                                 THAT IS DEMONSTRATED, BASED UPON THE
RECIPIENT’S CONTEMPORANEOUS WRITTEN RECORDS TO HAVE BEEN IN THE RECIPIENT’S
POSSESSION FROM A SOURCE NOT UNDER OBLIGATION OF SECRECY TO THE DISCLOSER PRIOR
TO THE DISCLOSURE; OR

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

22

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(C)                                  THAT BECOMES PART OF THE PUBLIC DOMAIN OR
PUBLICLY KNOWN BY PUBLICATION OR OTHERWISE, NOT DUE TO ANY UNAUTHORIZED ACT BY
THE RECIPIENT; OR

 

(D)                                 THAT IS DEMONSTRATED FROM CONTEMPORANEOUS
WRITTEN RECORDS TO HAVE BEEN DEVELOPED BY OR FOR THE RECIPIENT WITHOUT REFERENCE
TO CONFIDENTIAL INFORMATION DISCLOSED BY THE DISCLOSER.

 

8.3          INJUNCTION.  IN VIEW OF THE DIFFICULTIES OF PLACING A MONETARY
VALUE ON THE CONFIDENTIAL INFORMATION, IN THE EVENT OF A BREACH OF THIS
ARTICLE 8, THE DISCLOSER SHALL BE ENTITLED TO A PRELIMINARY AND FINAL INJUNCTION
WITHOUT THE NECESSITY OF POSTING ANY BOND OR UNDERTAKING IN CONNECTION THEREWITH
TO PREVENT FURTHER BREACH OF THIS ARTICLE 8 OR FURTHER UNAUTHORIZED USE OF ITS
CONFIDENTIAL INFORMATION.  THIS REMEDY IS SEPARATE FROM ANY OTHER REMEDY THE
DISCLOSER MAY HAVE.

 

8.4          RETURN OF CONFIDENTIAL INFORMATION.  UPON THE EXPIRATION OR
TERMINATION, FOR ANY REASON, OF THIS AGREEMENT, RECIPIENT SHALL RETURN PROMPTLY
TO DISCLOSER OR DESTROY, AT DISCLOSER’S OPTION, ALL TANGIBLE MATERIALS THAT
DISCLOSE OR EMBODY CONFIDENTIAL INFORMATION OF THE DISCLOSER.

 

8.5          RIGHT TO PUBLISH.  PRIOR TO SUBMISSION FOR PUBLICATION OF A
MANUSCRIPT DESCRIBING PATENT RIGHTS, JHU SHALL SEND THE COMPANY A COPY OF SUCH
MANUSCRIPT, AND SHALL ALLOW THE COMPANY SIXTY (60) DAYS FROM THE DATE OF RECEIPT
OF SUCH MAILING TO, AT ITS SOLE DISCRETION, COMMENT ON THE MANUSCRIPT, REMOVE
THE COMPANY’S CONFIDENTIAL INFORMATION AND FILE PATENT APPLICATIONS ON ANY
INVENTIONS RELATED TO THE PATENT RIGHTS AND DISCLOSED THEREIN.  IN NO CASE MAY
JHU PUBLISH COMPANY CONFIDENTIAL INFORMATION WITHOUT THE EXPRESS, WRITTEN
CONSENT OF COMPANY.

 

ARTICLE 9
TERM & TERMINATION

 

9.1          TERM.  SUBJECT TO EARLIER TERMINATION AS HEREIN PROVIDED, THE TERM
OF THIS AGREEMENT SHALL COMMENCE ON THE EFFECTIVE DATE AND SHALL CONTINUE UNTIL
THE LATER TO OCCUR OF (I) THE TWENTY (20) YEAR ANNIVERSARY OF THE EFFECTIVE
DATE, AND (II) THE DATE OF EXPIRATION OF THE LAST TO EXPIRE PATENT INCLUDED
WITHIN PATENT RIGHTS.

 

9.2          TERMINATION BY EITHER PARTY.  THIS AGREEMENT MAY BE TERMINATED BY
EITHER PARTY, IN THE EVENT THAT THE OTHER PARTY (A) FILES OR HAS FILED AGAINST
IT A PETITION UNDER THE BANKRUPTCY ACT, MAKES AN ASSIGNMENT FOR THE BENEFIT OF
CREDITORS, HAS A RECEIVER APPOINTED FOR IT OR A SUBSTANTIAL PART OF ITS ASSETS,
OR OTHERWISE TAKES ADVANTAGE OF ANY STATUTE OR LAW DESIGNED FOR RELIEF OF
DEBTORS OR (B) FAILS TO MATERIALLY PERFORM OR OTHERWISE MATERIALLY BREACHES ITS
OBLIGATIONS HEREUNDER, IF, FOLLOWING THE GIVING OF NOTICE BY THE TERMINATING
PARTY OF ITS INTENT TO TERMINATE AND STATING THE GROUNDS THEREFOR, THE PARTY
RECEIVING SUCH NOTICE SHALL NOT HAVE CURED THE FAILURE OR BREACH WITHIN SIXTY
(60) DAYS OF RECEIPT OF NOTICE (THE “CURE PERIOD”), OR, IF THE BREACH IS
INCAPABLE OF BEING CURED WITHIN THE CURE PERIOD, THE BREACHING PARTY MUST,
DURING THE CURE PERIOD, COMMENCE DILIGENT EFFORTS TO CURE SAID BREACH WHICH MUST
THEN BE CURED WITHIN NINETY

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

23

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(90) DAYS FOLLOWING THE CURE PERIOD IN ORDER TO PREVENT TERMINATION BY THE
NON-BREACHING PARTY.  IN NO EVENT, HOWEVER, SHALL SUCH NOTICE OR INTENTION TO
TERMINATE BE DEEMED TO WAIVE ANY RIGHTS TO DAMAGES OR ANY OTHER REMEDY WHICH THE
PARTY GIVING NOTICE OF BREACH MAY HAVE AS A CONSEQUENCE OF SUCH FAILURE OR
BREACH.

 

9.3          TERMINATION BY COMPANY.  JHU, THROUGH THE MOLECULAR GENETICS LAB,
MAY DISCOVER A NEW TECHNOLOGY DURING THE TERM OF THIS AGREEMENT.  JHU MAY, UPON
GIVING WRITTEN NOTICE TO EXACT, CAUSE THIS AGREEMENT TO BE AMENDED TO INCLUDE
ANY PATENT APPLICATION OR PATENT EMBODYING THE NEW TECHNOLOGY AMONG THE PATENT
RIGHTS AND TO EXTEND THE TERM OF THIS AGREEMENT TO THE DATE OF EXPIRATION OF ANY
PATENT ISSUED THEREON, PROVIDED THAT (I) THE RIGHT AND LICENSE GRANTED TO EXACT
ON THE NEW TECHNOLOGY SHALL BE EXCLUSIVE AND LIMITED TO THE FIELD DESCRIBED AS
FECAL BASED TESTS, THAT IS, A SCREENING ASSAY CONDUCTED ON A STOOL SAMPLE FOR
THE PURPOSE OF DIAGNOSING COLORECTAL NEOPLASIA, AND (II) EXACT AND JHU AGREE TO
NEGOTIATE IN GOOD FAITH ON A REASONABLE INCREASE TO THE AMOUNTS IN PARAGRAPHS
1.12.1(A) AND 1.12.2(A).  EXACT SHALL THEN HAVE THE RIGHT AND OPTION,
EXERCISABLE WITHIN THIRTY (30) DAYS OF SUCH NOTICE, TO REJECT SUCH AMENDMENT AND
THE INCLUSION HEREUNDER OF SUCH NEW TECHNOLOGY AMONG THE PATENT RIGHTS.  IN THE
EVENT THAT JHU DOES NOT CAUSE THIS AGREEMENT TO BE SO AMENDED AND, IN LIEU
THEREOF, LICENSES RIGHTS TO SUCH NEW TECHNOLOGY IN A FIELD THAT INCLUDES FECAL
BASED TESTS FOR COMMERCIAL AND OTHER THAN SOLELY RESEARCH PURPOSES TO A PARTY
OTHER THAN EXACT, THEN EXACT, AT ITS SOLE DISCRETION, SHALL HAVE THE RIGHT AND
OPTION, EXERCISABLE BY WRITTEN NOTICE GIVEN BY EXACT TO JHU WITHIN SIXTY (60)
DAYS AFTER THE CONSUMMATION BY JHU OF THE THIRD PARTY LICENSE (THE CONSUMMATION
OF WHICH JHU SHALL IMMEDIATELY NOTIFY EXACT), EITHER (A) TO TERMINATE THIS
AGREEMENT IMMEDIATELY AND WITHOUT RECOURSE BY JHU, AND WITH NO FURTHER PAYMENTS
DUE FROM EXACT TO JHU UNDER ARTICLE 3 HEREOF FOLLOWING THE DATE OF TERMINATION,
OR (B) TO ELECT NOT TO TERMINATE THIS AGREEMENT AND FOR THIS AGREEMENT TO
INSTEAD BE DEEMED AMENDED TO BECOME A PERPETUAL, EXCLUSIVE, ROYALTY-FREE LICENSE
TO THE PATENT RIGHTS THEN EXISTING IN THE FIELD OF FECAL BASED TESTS, TO EXACT,
WHEREUPON ALL THE PAYMENT OBLIGATIONS OF EXACT TO JHU UNDER ARTICLE 3 SHALL
TERMINATE, EXCEPT THAT EXACT SHALL PAY JHU A LICENSE MAINTENANCE FEE OF
[********] PER CALENDAR YEAR, PAYABLE WITHIN THIRTY (30) DAYS AFTER DECEMBER 31
OF EACH YEAR DURING WHICH THIS AGREEMENT IS IN EFFECT.  NOTWITHSTANDING THE
FOREGOING, IF THIS AGREEMENT IS CONVERTED INTO A PERPETUAL, ROYALTY-FREE,
EXCLUSIVE LICENSE UNDER THE PROVISIONS OF THIS PARAGRAPH 9.3, ALL PROVISIONS OF
THIS AGREEMENT, EXCEPT FOR THE PAYMENT PROVISIONS CONTAINED IN ARTICLE 3 HEREOF,
SHALL REMAIN IN FULL FORCE AND EFFECT TO THE EXTENT THEY ARE NOT INCONSISTENT
WITH THIS SECTION 9.3, AND EXACT SHALL PAY ALL AMOUNTS CURRENTLY DUE PRIOR TO
THE DATE OF SUCH CONVERSION.  FOR THE AVOIDANCE OF DOUBT, IN THE EVENT EXACT
ELECTS TO PROCEED UNDER CLAUSE (B) ABOVE, EXACT SHALL NO LONGER BE REQUIRED TO
PAY JHU ANY AMOUNTS (OTHER THAN THE [********] PER YEAR MAINTENANCE FEE) WHICH
WOULD HAVE OTHERWISE ACCRUED PROSPECTIVELY TO JHU HAD EXACT NOT SO ELECTED.  FOR
THE FURTHER AVOIDANCE OF DOUBT, THIS PARAGRAPH 9.3 SHALL NOT BE CONSTRUED AS A
RIGHT OF FIRST REFUSAL OR FIRST OPTION OR EXCLUSIVE NEGOTIATION BETWEEN JHU AND
EXACT; INSTEAD THIS PARAGRAPH 9.3 OBLIGES JHU TO MAKE NEW TECHNOLOGY AVAILABLE
TO EXACT ON AT LEAST AN EQUAL BASIS WITH ALL OTHER PARTIES, OR FAILING THAT,
GIVES EXACT THE RIGHT TO PROCEED UNDER CLAUSE (A) OR (B) OF THIS PARAGRAPH 9.3.

 

9.4          OBLIGATIONS AND DUTIES UPON TERMINATION.  IF THIS AGREEMENT IS
TERMINATED, BOTH PARTIES SHALL BE RELEASED FROM ALL OBLIGATIONS AND DUTIES
IMPOSED OR ASSUMED HEREUNDER TO THE EXTENT SO TERMINATED, EXCEPT AS EXPRESSLY
PROVIDED TO THE CONTRARY IN THIS AGREEMENT. 

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

24

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TERMINATION OF THIS AGREEMENT, FOR WHATEVER REASON, SHALL NOT AFFECT THE
OBLIGATION OF EITHER PARTY TO MAKE ANY PAYMENTS FOR WHICH IT IS LIABLE PRIOR TO
OR UPON SUCH TERMINATION AND WHICH WERE ORIGINALLY INTENDED TO BE PAID PRIOR TO
THE TERMINATION (I.E.  ANY FLAT FEE AMOUNTS THAT ARE BEING PAID TO JHU PURSUANT
TO ARTICLE 3 SHALL IMMEDIATELY CEASE WITH NO FURTHER AMOUNTS DUE JHU
HEREUNDER).  TERMINATION SHALL NOT AFFECT JHU’S RIGHT TO RECOVER AMOUNTS FOR
WHICH PAYMENT IS PAST DUE (INCLUDING REIMBURSEMENT FOR PATENT EXPENSES INCURRED
PURSUANT TO ARTICLE 4 PRIOR TO TERMINATION).  UPON TERMINATION, COMPANY SHALL
SUBMIT A FINAL ROYALTY REPORT TO JHU TO CONFIRM THE AMOUNTS DUE JHU AS OF THE
DATE OF TERMINATION AND PAYMENT OF SUCH AMOUNTS SHALL BE DUE TO JHU NO LATER
THAN THIRTY (30) DAYS OF THE DATE OF TERMINATION.  FURTHERMORE, UPON TERMINATION
OF THIS AGREEMENT FOR ANY REASON, ALL RIGHTS IN AND TO THE PATENT RIGHTS SHALL
REVERT IMMEDIATELY TO JHU, AT NO COST TO JHU, PROVIDED, HOWEVER, THAT, IN THE
EVENT THIS AGREEMENT TERMINATES DUE TO EXACT’S DISSOLUTION, ALL COMPANY
SUBLICENSES UNDER THE PATENT RIGHTS EXISTING AS OF THE DATE OF TERMINATION SHALL
CONTINUE IN FULL FORCE AND EFFECT, AS A DIRECT LICENSE BETWEEN JHU AND SUCH
SUBLICENSEE, PROVIDED THAT JHU’S OBLIGATIONS AND SAID SUBLICENSEE’ S OBLIGATIONS
UNDER SUCH SUBLICENSES ARE NO GREATER THAN CURRENTLY EXISTING UNDER THIS
AGREEMENT AND THE SUBLICENSE AGREEMENT, RESPECTIVELY.  IN THE EVENT THIS
AGREEMENT SHOULD TERMINATE FOR REASONS OTHER THAN EXACT’S DISSOLUTION, THEN SUCH
SUBLICENSES ENTERED INTO PRIOR TO THIS AGREEMENT’S TERMINATION SHALL REMAIN IN
FULL FORCE AND EFFECT AND COMPANY AND JHU SHALL CONTINUE TO HONOR THEIR
OBLIGATIONS TO EACH OTHER, AS SUCH OBLIGATIONS EXISTED AS OF THE DATE OF SUCH
TERMINATION, ONLY WITH RESPECT TO SUCH SUBLICENSEES.

 

ARTICLE 10
MISCELLANEOUS

 

10.1        USE OF NAME.  NEITHER PARTY SHALL USE THE NAME OF THE OTHER, OR THE
OTHER’S AFFILIATES OR SUBLICENSEES (WHERE “OTHER” IN THE CASE OF JHU MEANS AND
INCLUDES NOT ONLY JHU BUT ALSO THE HOWARD HUGHES MEDICAL INSTITUTE, THE JOHNS
HOPKINS UNIVERSITY OR THE JOHNS HOPKINS HEALTH SYSTEM AND ANY OF THEIR OR ITS
CONSTITUENT PARTS, SUCH AS THE JOHNS HOPKINS HOSPITAL OR ANY CONTRACTION
THEREOF, AS WELL AS THE NAME OF THE INVENTORS OF PATENT RIGHTS), IN ANY
ADVERTISING, PROMOTIONAL, SALES LITERATURE, PRESS RELEASES OR FUNDRAISING
DOCUMENTS WITHOUT PRIOR WRITTEN CONSENT FROM AN OFFICER OF SAID PARTY. 
FURTHERMORE, NEITHER PARTY SHALL USE THE NAME OF THE OTHER, OR THE OTHER’S
AFFILIATES OR SUBLICENSEES (WHERE “OTHER” IN THE CASE OF JHU MEANS AND INCLUDES
NOT ONLY JHU BUT ALSO THE HOWARD HUGHES MEDICAL INSTITUTE, THE JOHNS HOPKINS
UNIVERSITY OR THE JOHNS HOPKINS HEALTH SYSTEM AND ANY OF THEIR OR ITS
CONSTITUENT PARTS, SUCH AS THE JOHNS HOPKINS HOSPITAL OR ANY CONTRACTION
THEREOF, AS WELL AS THE NAME OF THE INVENTORS OF PATENT RIGHTS), IN ANY
ADVERTISING, PROMOTIONAL, SALES LITERATURE, PRESS RELEASES OR FUNDRAISING
DOCUMENTS DISCLOSING TECHNOLOGY THAT THE PARTIES HAVE PARTICIPATED IN, DEVELOPED
OR HAVE OTHERWISE COLLABORATED ON, WITHOUT PRIOR WRITTEN CONSENT FROM AN OFFICER
OF SAID PARTY.  EACH PARTY SHALL ALLOW AT LEAST SEVEN (7) BUSINESS DAYS NOTICE
OF ANY PROPOSED PUBLIC DISCLOSURE FOR JHU’S OR EXACT’S REVIEW AND COMMENT OR TO
PROVIDE WRITTEN CONSENT WHICH SHALL NOT BE UNREASONABLY WITHHELD.  FOR PURPOSES
OF THIS PARAGRAPH, NOTICE TO EXACT SHALL BE DELIVERED AS INDICATED IN
SECTION 10.6 HEREOF AND NOTICE TO HHMI SHALL BE DELIVERED AS FOLLOWS: HOWARD
HUGHES MEDICAL INSTITUTE, 4000 JONES BRIDGE ROAD, CHEVY CHASE, MARYLAND 20815,
ATTN: OFFICE OF THE GENERAL COUNSEL; OR TO SUCH OTHER ADDRESS AS HHMI SHALL GIVE
NOTICE OF FROM TIME TO TIME.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

25

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10.2        NO PARTNERSHIP.  NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED TO
CREATE ANY AGENCY, EMPLOYMENT, PARTNERSHIP, JOINT VENTURE OR SIMILAR
RELATIONSHIP BETWEEN THE PARTIES OTHER THAN THAT OF A LICENSOR/LICENSEE.  EXCEPT
AS EXPRESSLY PROVIDED HEREIN, NEITHER PARTY SHALL HAVE ANY RIGHT OR AUTHORITY
WHATSOEVER TO INCUR ANY LIABILITY OR OBLIGATION (EXPRESS OR IMPLIED) OR
OTHERWISE ACT IN ANY MANNER IN THE NAME OR ON THE BEHALF OF THE OTHER, OR TO
MAKE ANY PROMISE, WARRANTY OR REPRESENTATION BINDING ON THE OTHER.

 

10.3        NOTICE OF CLAIM.  EACH PARTY SHALL GIVE THE OTHER OR ITS
REPRESENTATIVE IMMEDIATELY NOTICE OF ANY SUIT OR ACTION FILED, OR PROMPT NOTICE
OF ANY CLAIM MADE, AGAINST THEM ARISING OUT OF THE PERFORMANCE OF THIS
AGREEMENT.

 

10.4        PRODUCT LIABILITY.  PRIOR TO INITIAL HUMAN TESTING OR FIRST
COMMERCIAL SALE OF ANY FECAL BASED TEST THAT USE PATENT RIGHTS OR OTHER ITEM AS
THE CASE MAY BE IN ANY PARTICULAR COUNTRY, COMPANY SHALL ESTABLISH AND MAINTAIN,
IN EACH COUNTRY IN WHICH COMPANY OR SUBLICENSEE SHALL TEST OR SELL FECAL BASED
TEST THAT USE PATENT RIGHTS OR OTHER ITEMS, PRODUCT LIABILITY OR OTHER
APPROPRIATE INSURANCE COVERAGE IN THE MINIMUM AMOUNT OF [********] PER CLAIM 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 AND HHMI 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.

 

10.5        GOVERNING LAW.  THIS AGREEMENT SHALL BE CONSTRUED IN ACCORDANCE WITH
THE LAWS OF THE STATE OF DELAWARE WITHOUT GIVING EFFECT TO THE PRINCIPLES OF
CONFLICTS OF LAWS.

 

10.6        NOTICE.  ALL NOTICES OR COMMUNICATION REQUIRED OR PERMITTED TO BE
GIVEN BY EITHER PARTY HEREUNDER SHALL BE DEEMED SUFFICIENTLY GIVEN IF MAILED BY
REGISTERED MAIL OR CERTIFIED MAIL OR SENT BY OVERNIGHT COURIER, SUCH AS FEDERAL
EXPRESS, TO THE OTHER PARTY AT ITS RESPECTIVE ADDRESS SET FORTH BELOW OR TO SUCH
OTHER ADDRESS AS ONE PARTY SHALL GIVE NOTICE OF TO THE OTHER FROM TIME TO TIME
HEREUNDER.  MAILED NOTICES SHALL BE DEEMED TO BE RECEIVED ON THE THIRD BUSINESS
DAY FOLLOWING THE DATE OF MAILING.  NOTICES SENT BY OVERNIGHT COURIER SHALL BE
DEEMED RECEIVED THE FOLLOWING BUSINESS DAY.

 

If to Company:

 

Exact Sciences Corporation
63 Great Road
Maynard, MA 01754
Attn: President

 

 

 

If to JHU

 

Office of Technology Licensing
The Johns Hopkins University School of Medicine
111 Market Place, Suite 906
Baltimore, MD 21202
Attn: Director

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

26

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10.7        COMPLIANCE WITH ALL LAWS.  IN ALL ACTIVITIES UNDERTAKEN PURSUANT TO
THIS AGREEMENT, BOTH JHU AND COMPANY COVENANT AND AGREE THAT EACH WILL IN ALL
MATERIAL RESPECTS COMPLY WITH SUCH FEDERAL, STATE AND LOCAL LAWS AND STATUTES,
AS MAY BE IN EFFECT AT THE TIME OF PERFORMANCE AND ALL VALID RULES, REGULATIONS
AND ORDERS THEREOF REGULATING SUCH ACTIVITIES.

 

10.8        SUCCESSORS AND ASSIGNS.  NEITHER THIS AGREEMENT NOR ANY OF THE
RIGHTS OR OBLIGATIONS CREATED HEREIN, EXCEPT FOR THE RIGHT TO RECEIVE ANY
REMUNERATION HEREUNDER, MAY BE ASSIGNED BY EITHER PARTY, IN WHOLE OR IN PART,
WITHOUT THE PRIOR WRITTEN CONSENT OF THE OTHER PARTY.  NOTWITHSTANDING THE
PRECEDING SENTENCE, JHU AND COMPANY SHALL BE FREE TO ASSIGN THIS AGREEMENT IN
CONNECTION WITH ANY SALE OF SUBSTANTIALLY ALL OF SUCH PARTY’S ASSETS WITHOUT THE
CONSENT OF THE OTHER PARTY HEREUNDER, AND COMPANY AND JHU SHALL BE FREE TO
ASSIGN THIS AGREEMENT OR OTHERWISE TO TRANSFER ALL OF THEIR RESPECTIVE RIGHTS
AND OBLIGATIONS UNDER THIS AGREEMENT TO A SUCCESSOR BY MERGER UPON THE PRIOR
WRITTEN CONSENT OF THE OTHER HEREUNDER, WHICH CONSENT SHALL NOT BE UNREASONABLY
WITHHELD, CONDITIONED OR DELAYED.  THIS AGREEMENT SHALL BIND AND INURE TO THE
BENEFIT OF THE SUCCESSORS AND PERMITTED ASSIGNS OF THE PARTIES HERETO.

 

10.9        NO WAIVERS; SEVERABILITY.  NO WAIVER OF ANY BREACH OF THIS AGREEMENT
SHALL CONSTITUTE A WAIVER OF ANY OTHER BREACH OF THE SAME OR OTHER PROVISION OF
THIS AGREEMENT, AND NO WAIVER SHALL BE EFFECTIVE UNLESS MADE IN WRITING.  ANY
PROVISION HEREOF PROHIBITED BY OR UNENFORCEABLE UNDER ANY APPLICABLE LAW OF ANY
JURISDICTION SHALL AS TO SUCH JURISDICTION BE DEEMED INEFFECTIVE AND DELETED
HEREFROM WITHOUT AFFECTING ANY OTHER PROVISION OF THIS AGREEMENT.  IT IS THE
DESIRE OF THE PARTIES HERETO THAT THIS AGREEMENT BE ENFORCED TO THE MAXIMUM
EXTENT PERMITTED BY LAW, AND SHOULD ANY PROVISION CONTAINED HEREIN BE HELD BY
ANY GOVERNMENTAL AGENCY OR COURT OF COMPETENT JURISDICTION TO BE VOID, ILLEGAL
AND UNENFORCEABLE, THE PARTIES SHALL NEGOTIATE IN GOOD FAITH FOR A SUBSTITUTE
TERM OR PROVISION WHICH CARRIES OUT THE ORIGINAL INTENT OF THE PARTIES.

 

10.10      ENTIRE AGREEMENT; AMENDMENT.  COMPANY AND JHU ACKNOWLEDGE THAT THEY
HAVE READ THIS ENTIRE AGREEMENT AND THAT THIS AGREEMENT, INCLUDING THE ATTACHED
EXHIBITS CONSTITUTES THE ENTIRE UNDERSTANDING AND CONTRACT BETWEEN THE PARTIES
HERETO AND SUPERSEDES ANY AND ALL PRIOR OR CONTEMPORANEOUS ORAL OR WRITTEN
COMMUNICATIONS WITH RESPECT TO THE SUBJECT MATTER HEREOF (INCLUDING THE PRIOR
LICENSE AGREEMENT) AND (EXCEPT AS SPECIFICALLY CONTEMPLATED BY PARAGRAPH 3.4 AND
9.3 HEREOF) THIS AGREEMENT SHALL NOT BE MODIFIED, AMENDED OR IN ANY WAY ALTERED
EXCEPT BY AN INSTRUMENT IN WRITING SIGNED BY BOTH OF THE PARTIES HERETO.

 

10.11      DELAYS OR OMISSIONS.  EXCEPT AS EXPRESSLY PROVIDED HEREIN, NO DELAY
OR OMISSION TO EXERCISE ANY RIGHT, POWER OR REMEDY ACCRUING TO ANY PARTY HERETO,
SHALL IMPAIR ANY SUCH RIGHT, POWER OR REMEDY TO SUCH PARTY NOR SHALL IT BE
CONSTRUED TO BE A WAIVER OF ANY SUCH BREACH OR DEFAULT, OR AN ACQUIESCENCE
THEREIN, OR IN ANY SIMILAR BREACH OR DEFAULT BE DEEMED A WAIVER OF ANY OTHER
BREACH OR DEFAULT THERETOFORE OR THEREAFTER OCCURRING.  ANY WAIVER, PERMIT,
CONSENT OR APPROVAL OF ANY KIND OR CHARACTER ON THE PART OF ANY PARTY OF ANY
BREACH OR DEFAULT UNDER THIS AGREEMENT, OR ANY WAIVER ON THE PART OF ANY PARTY
OF ANY PROVISIONS OR CONDITIONS OF THIS AGREEMENT, MUST BE IN WRITING AND SHALL
BE EFFECTIVE ONLY TO THE EXTENT SPECIFICALLY SET FORTH IN

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

27

--------------------------------------------------------------------------------

 

such writing.  All remedies either under this Agreement or by law or otherwise
afforded to any party, shall be cumulative and not alternative.

 

10.12      FORCE MAJEURE.  IF EITHER PARTY FAILS TO FULFILL ITS OBLIGATIONS
HEREUNDER (OTHER THAN AN OBLIGATION FOR THE PAYMENT OF MONEY), WHEN SUCH FAILURE
IS DUE TO AN ACT OF GOD, OR OTHER CIRCUMSTANCES BEYOND ITS REASONABLE CONTROL,
INCLUDING BUT NOT LIMITED TO FIRE, FLOOD, CIVIL COMMOTION, RIOT, WAR (DECLARED
AND UNDECLARED), ACTS OF TERRORISM, REVOLUTION, OR EMBARGOES, THEN SAID FAILURE
SHALL BE EXCUSED FOR THE DURATION OF SUCH EVENT AND FOR SUCH A TIME THEREAFTER
AS IS REASONABLE TO ENABLE THE PARTIES TO RESUME PERFORMANCE UNDER THIS
AGREEMENT.

 

10.13      FURTHER ASSURANCES.  EACH PARTY SHALL, AT ANY TIME, AND FROM TIME TO
TIME, DURING THE TERM OF THIS AGREEMENT, AT REASONABLE REQUEST OF THE OTHER
PARTY, EXECUTE AND DELIVER TO THE OTHER SUCH INSTRUMENTS AND DOCUMENTS AND SHALL
TAKE SUCH ACTIONS AS MAY BE REQUIRED TO IMPLEMENT THE TERMS OF THIS AGREEMENT.

 

10.14      SURVIVAL.  ARTICLES 1, 6, 7, 8, 9, AND 10, AND PARAGRAPHS 2.4, 5.1
AND 5.2, SHALL SURVIVE ANY EXPIRATION OR TERMINATION OF THIS AGREEMENT.

 

10.15      NO THIRD PARTY BENEFICIARIES.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED
HEREIN TO THE CONTRARY, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS GIVING
ANY PERSON, FIRM, CORPORATION OR OTHER ENTITY, OTHER THAN THE PARTIES HERETO AND
THEIR SUCCESSORS AND PERMITTED ASSIGNS, ANY RIGHT, REMEDY OR CLAIM UNDER OR IN
RESPECT OF THIS AGREEMENT OR ANY PROVISION HEREOF.

 

10.16      HEADINGS.  ARTICLE HEADINGS ARE FOR CONVENIENT REFERENCE AND NOT A
PART OF THIS AGREEMENT.  ALL EXHIBITS ARE INCORPORATED HEREIN BY THIS REFERENCE.

 

10.17      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.

 

10.18      AFFILIATE RIGHTS AND OBLIGATIONS.  THE LICENSE GRANTED HEREUNDER
SHALL EXTEND TO ALL AFFILIATES OF EXACT SCIENCES CORPORATION (BUT NOT, IN TURN,
TO THEIR AFFILIATES, AND SHALL EXTEND TO AN AFFILIATE FOR ONLY SO LONG AS THE
AFFILIATE REMAINS AN AFFILIATE) WHO NOTIFY JHU IN WRITING THAT THEY ACCEPT THE
TERMS, INCLUDING THE OBLIGATIONS, OF THIS AGREEMENT AS BINDING UPON THEM JOINTLY
AND SEVERALLY WITH EXACT SCIENCES CORPORATION AND ITS OTHER AFFILIATES SO
ACCEPTING; PROVIDED, HOWEVER, THAT (I) IN NO EVENT SHALL ANY SUCH AFFILIATE HAVE
ANY RIGHT TO SUBLICENSE UNDER PARAGRAPH 2.2 HEREOF; (II) IN NO EVENT SHALL ANY
SUCH AFFILIATE HAVE ANY RIGHT TO ASSIGN OR TRANSFER ANY RIGHTS INURING TO IT
HEREUNDER, AS OTHERWISE CONTEMPLATED BY PARAGRAPH 10.8 HEREOF; AND (III) ANY AND
ALL COMMUNICATIONS OR NOTICES TO BE GIVEN, OR ELECTIONS MADE OR TO BE MADE,
UNDER OR IN RESPECT OF THIS AGREEMENT SHALL BE MADE ONLY BY EXACT SCIENCES
CORPORATION ON ITS OWN BEHALF, AND IF AND WHEN APPROPRIATE, ON BEHALF OF ITS
AFFILIATES.

 

10.19      HOWARD HUGHES MEDICAL INSTITUTE (HHMI).  HHMI IS NOT A PARTY TO THIS
AGREEMENT AND HAS NO LIABILITY TO EXACT, ANY SUBLICENSEE, ANY AFFILIATED COMPANY
OR USER OF ANY THING OR MATTER COVERED BY THIS AGREEMENT, BUT HHMI IS AN
INTENDED

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

28

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third party beneficiary of this Agreement and certain of the provisions hereof
are for the benefit of HHMI and shall be enforceable by HHMI in its own name.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

29

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IN WITNESS WHEREOF, this Agreement shall take effect as of the EFFECTIVE DATE
when it has been executed below by the duly authorized representatives of the
parties.

 

THE JOHNS HOPKINS UNIVERSITY

EXACT SCIENCES CORPORATION

 

 

 

 

By

:  /s/ William P. Tew

 

By

:

/s Don Hardison

Name:

William P. Tew, Ph.D.

 

Name: Don Hardison

Title:

Assistant Dean and Executive

 

Title: President and CEO

 

Director Division of Licensing and

 

 

Business Development, School of

 

 

Medicine

 

 

 

3/25/03

 

3/21/03

(Date)

(Date)

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

30

--------------------------------------------------------------------------------

 

INVENTOR’S ACKNOWLEDGEMENT

 

I have read and give to abide by the terms of the within Agreement:

 

 

By:

  /s/ Bert Vogelstein

 

By:

  /s/ Kenneth Kinzler

 

  Dr. Bert Vogelstein

 

 

  Kenneth Kinzler, Ph.D.

 

 

 

 

 

 

Date:

    3/24/03

 

Date:

    3/24/03

 

 

 

 

 

 

By:

  /s/ C. Giovanni Traverso

 

 

 

C. Giovanni Traverso, Ph.D.

 

 

 

 

 

 

 

 

Date:

  March 24, 2003

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

31

--------------------------------------------------------------------------------

 

EXHIBIT A
PATENT RIGHTS

 

[********]

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

SECOND AMENDMENT TO LICENSE AGREEMENT BETWEEN

EXACT SCIENCES CORPORATION

AND

THE JOHNS HOPKINS UNIVERSITY

 

This Second Amendment (this “Amendment”) is made and effective as of November 9,
2004 by and between The Johns Hopkins University (“JHU”) and EXACT Sciences
Corporation (“EXACT”).

 

WHEREAS, JHU and EXACT entered into an amended and restated license agreement
(the “Agreement”) having a final signature date of March, 25, 2003 (the
“EFFECTIVE DATE”); and

 

WHEREAS, the parties desire to amend certain provisions of the Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties agree to the following amendments to the
Agreement, to be effective as of the date of execution of this Amendment:

 

1.                                       SECTIONS 1.12.1(A) AND 1.12.2(A) OF THE
AGREEMENT ARE HEREBY REPLACED IN THEIR ENTIRETY WITH THE FOLLOWING:

 

“[********]; and”

 

The parties hereby agree that all references, express or implied, to the
[********] minimum license fee set fort in the Agreement shall, instead, be
amended to reference [********] and any calculations set forth in the Agreement,
for purposes of example, shall be deemed illustrative only to the extent
appropriate based on the change in minimum annual fee from [********] to
[********] as set forth above.

 

2.                                       THE PATENT APPLICATION IDENTIFIED BELOW
IS HEREBY DEEMED INCLUDED IN EXHIBIT A OF THE AGREEMENT:

 

[********]

 

3.                                       THE FIELD, FOR PURPOSES OF THE ABOVE
PATENT ONLY, SHALL BE FECAL BASED TESTS, THAT IS, A SCREENING ASSAY CONDUCTED ON
A STOOL SAMPLE FOR THE PURPOSE OF DIAGNOSING COLORECTAL NEOPLASIA.

 

4.                                       SECTION 10.6 OF THE AGREEMENT IS HEREBY
REPLACED IN ITS ENTIRETY WITH THE FOLLOWING:

 

10.6        Notice.  All notices or communication required or permitted to be
given by either party hereunder shall be deemed sufficiently given if mailed by
registered mail or certified mail or sent by overnight courier, such as Federal
Express, to the other party at its respective address set forth below or to such
other address as one party shall give notice of to the other from

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

time to time hereunder.  Mailed notices shall be deemed to be received on the
third business day following the date of mailing.  Notices sent by overnight
courier shall be deemed received the following business day.

 

If to Company:

 

Exact Sciences Corporation
100 Campus Drive
Marlborough, MA 01752
Attn: President

 

 

 

If to JHU:

 

Licensing and Technology Development
Johns Hopkins University
100 N. Charles Street\
5th Floor
Baltimore, MD 21201 Attn: Director

 

5.                                       EXCEPT AS EXPRESSLY MODIFIED HEREIN,
THE AGREEMENT AND ALL OF ITS TERMS AND CONDITIONS SHALL CONTINUE IN FULL FORCE
AND EFFECT.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this Amendment as of the date first above written.

 

EXACT Sciences Corporation

 

The Johns Hopkins University

 

 

 

By:

/s/ Don Hardison

 

By:

/s/ R. Keith Baker

 

 

 

 

Printed Name:

Don Hardison

 

Printed Name:

R. Keith Baker

 

 

 

 

Title:

President and CEO

 

Title:

Director

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

2

--------------------------------------------------------------------------------

 

THIRD AMENDMENT TO LICENSE AGREEMENT BETWEEN

EXACT SCIENCES CORPORATION

AND
THE JOHNS HOPKINS UNIVERSITY

 

This Third Amendment (this “Amendment”) is made and effective as of May 11,
2006, by and between The Johns Hopkins University (“JHU”) and EXACT Sciences
Corporation (“EXACT”).

 

WHEREAS, JHU and EXACT entered into an amended and restated license agreement
(the “Agreement”) having a final signature date of March 25, 2003 (the
“EFFECTIVE DATE”);

 

WHEREAS, JHU and EXACT amended the Agreement on November 9, 2004; and

 

WHEREAS, the parties desire to further amend certain provisions of the
Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties agree to the following amendments to the
Agreement, to be effective as of the date of execution of this Amendment:

 

1.                                       SECTIONS 1.12.1(A) AND 1.12.2(A) OF THE
AGREEMENT ARE HEREBY REPLACED IN THEIR ENTIRETY WITH THE FOLLOWING:

 

“[********]; and”

 

The parties hereby agree that all references, express or implied, to the
[********] minimum license fee set fort in the Agreement shall, instead, be
amended to reference [********] and any calculations set forth in the Agreement,
for purposes of example, shall be deemed illustrative only to the extent
appropriate based on the change in minimum annual fee from [********] to
[********] as set forth above.

 

2.                                       THE PATENT APPLICATIONS IDENTIFIED
BELOW (HEREINAFTER THE “BEAMING PATENT RIGHTS”) ARE HEREBY DEEMED INCLUDED IN
EXHIBIT A OF THE AGREEMENT:

 

[********]

 

3.                                       BEAMING EXCLUSIVE FIELD, FOR PURPOSES
OF THE BEAMING PATENT RIGHTS ONLY, SHALL MEAN A SCREENING ASSAY ON A STOOL
SAMPLE FOR THE PURPOSE OF DIAGNOSING COLORECTAL NEOPLASIA.

 

4.                                       BEAMING NONEXCLUSIVE FIELD, FOR
PURPOSES OF THE BEAMING PATENT RIGHTS ONLY, SHALL MEAN A SCREENING ASSAY ON A
BLOOD SAMPLE FOR THE PURPOSE OF DETECTING COLORECTAL NEOPLASIA.

 

5.                                       THE FOLLOWING SECTIONS 2.1.1.  AND
2.1.2.  ARE HEREBY DEEMED A PART OF THE AGREEMENT:

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

2.1.1.  Grant.  Subject to the terms and conditions of the Agreement, and
expressly subject to Article 2.3 therein, JIM hereby grants to COMPANY an
exclusive license under the BEAMING PATENT RIGHTS in the BEAMING EXCLUSIVE FIELD
to make, have made, use, have used, sell, have sold, import, and have imported
any method, service or product worldwide.

 

2.1.2.  Grant.  Subject to the terms and conditions of the Agreement, and
expressly subject to Article 2.3 therein, JHU hereby grants to COMPANY a
non-exclusive license under the BEAMING PATENT RIGHTS in the BEAMING
NONEXCLUSIVE FIELD to make, have made, use, have used, sell, have sold, import,
and have imported any method, service or product worldwide.

 

6.                                       COMPANY SHALL INITIALLY HAVE THE SOLE
AND EXCLUSIVE RIGHT, BUT NOT THE OBLIGATION TO INITIATE AND CARRY ON LEGAL
PROCEEDINGS, AT COMPANY’S SOLE EXPENSE AND IN JHU’S AND HHMI’S NAME, IF SO
REQUIRED BY LAW, AGAINST ANY INFRINGER OR ALLEGED INFRINGER OF ANY PATENT OR
PATENT APPLICATION WITHIN BEAMING PATENT RIGHTS WITHIN THE BEAMING EXCLUSIVE
FIELD ONLY.  SUCH RIGHT SHALL INCLUDE THE RIGHT TO BRING SUIT AND COLLECT
DAMAGES FOR PAST INFRINGEMENT OF ANY PATENT WITHIN THE BEAMING PATENT RIGHTS IN
THE BEAMING EXCLUSIVE FIELD.  COMPANY SHALL CONTROL ALL ASPECTS OF ANY SUCH
PROCEEDING, INCLUDING, WITHOUT LIMITATION, THE STRATEGY, DEFENSE, AND SETTLEMENT
OF SUCH PROCEEDING, AND SHALL DO SO IN A MANNER CONSISTENT WITH THE TERMS AND
PROVISIONS HEREOF.

 

Subject to Paragraph 4.8, any damage, cost, award, fee, recovery, or
compensation paid by any third party in connection with any proceeding initiated
or carried on at COMPANY’S expense (whether by way of settlement or otherwise)
shall be retained by the COMPANY.  The COMPANY shall not enter into any
settlement, consent judgment, or any other voluntary final disposition of any
infringement action under this Paragraph without the prior written consent of
JHU, which shall not be unreasonably withheld, conditioned or delayed. 
Company’s right to sue for infringement hereunder shall not be used in an
arbitrary or capricious manner.

 

7.                                       THE FOLLOWING SECTION 9.5 IS HEREBY
DEEMED A PART OF THE AGREEMENT:

 

9.5 Termination of License to BEAMING PATENT RIGHTS Only.  EXACT may, at its
discretion, terminate its license with respect to the BEAMING PATENT RIGHTS
only, upon thirty (30) days written notice to JHU.  Under such circumstances,
EXACT shall no longer be responsible for patent prosecution and maintenance
costs related to the BEAMING PATENT RIGHTS and the Annual License Fee due from
EXACT to JHU shall be reduced by [********] as of the immediately upcoming
annual payment date.  EXACT shall not be entitled to a refund of any amounts
previously owed to JHU, regardless of when EXACT exercises its rights under this
provision.

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.

 

2

--------------------------------------------------------------------------------

 

8.                                       EXCEPT AS EXPRESSLY MODIFIED HEREIN,
THE AGREEMENT AND ALL OF ITS TERMS AND CONDITIONS SHALL CONTINUE IN FULL FORCE
AND EFFECT.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this Amendment as of the date first above written.

 

EXACT Sciences Corporation

 

The Johns Hopkins University

 

 

 

By:

/s/ Don Hardison

 

By:

/s/ Jill A. Tarzian Sorensen

 

 

 

 

 

Printed Name:

Don Hardison

 

Printed Name:

Jill A. Tarzian Sorensen

 

 

 

 

 

Title:

President and CEO

 

Title:

Executive Director

 

 

 

 

Johns Hopkins Technology Transfer

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.

 

3

--------------------------------------------------------------------------------

 

FOURTH AMENDMENT TO LICENSE AGREEMENT BETWEEN

EXACT SCIENCES CORPORATION

AND

THE JOHNS HOPKINS UNIVERSITY

 

This Fourth Amendment (this “Amendment”) is made and effective as of March 19,
2007, by and between The Johns Hopkins University (“JHU”) and EXACT Sciences
Corporation (“EXACT”).

 

WHEREAS, JHU and EXACT entered into an amended and restated license agreement
(the “Agreement”) having a final signature date of March, 25, 2003 (the
“EFFECTIVE DATE”);

 

WHEREAS, JHU and EXACT amended the Agreement on November 9, 2004 and again on
May 11, 2006; and

 

WHEREAS, the parties desire to further amend certain provisions of the
Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties agree to the following amendments to the
Agreement, to be effective as of the date of execution of this Amendment:

 

1.     The first sentence of Section 3.3 of the Agreement is hereby amended as
follows:

 

3.3              Payment Schedule.  Payments accruing from COMPANY to JHU
pursuant to Paragraph 3.2 shall be payable in the calendar year following the
close of the calendar year which serves as the measurement year in respect
thereof, and such payment shall be made in two (2) equal installments, which
shall be due and payable thirty (30) days after each of June 30 and December 31,
respectively, except that the payment due thirty (30) days after June 30, 2007
shall be due thirty (30) days after May 31, 2007.

 

2.     Section 3.5 of the Agreement is hereby replaced in its entirety with the
following:

 

3.5              Form of Payment.  Except as provided below, all payments under
this Agreement shall be made in U.S. Dollars.  The parties agree that the
[********] license fee amount due for the period ending December 31, 2006, shall
be paid to JHU in the form of EXACT unregistered common stock (the “Shares”) in
an amount equal to $158,125.00 by March 23, 2007 or on such date when all JHU
approvals are complete.  All cash payments made pursuant to this agreement shall
be made payable to “The Johns Hopkins University”.  Wire transfers may be made
through:

 

[********]

 

PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY’S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES
OMISSIONS.

 

--------------------------------------------------------------------------------

 

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

 

The parties hereby agree that all references, express or implied, to requiring
that payment be made only in cash  shall, instead, be amended to reference
EXACT’s ability to make certain license fee payments in EXACT common stock, upon
mutual agreement of the parties.

 

3.     Section 6.2 below is hereby incorporated into the Agreement:

 

6.2          Investment Representation.  JHU represents, warrants and
acknowledges that: (i) (A) JHU is an “accredited investor” as defined in
Regulation D under the Securities Act and is knowledgeable, sophisticated and
experienced in making, and is qualified to make decisions with respect to
investments in shares presenting an investment decision like that involved in
EXACT, including investments in securities issued by EXACT and investments in
comparable companies, and has requested, received, reviewed and considered all
information it deemed relevant in making an informed decision to invest in EXACT
and (B) EXACT has made available to JHU, prior to the date hereof, the
opportunity to ask questions of and receive complete and correct answers from
representatives of EXACT concerning the terms and conditions of the Shares and
to obtain any additional information relating to the financial condition and
business of EXACT and JHU has such knowledge and experience in financial and
business matters that JHU is capable of evaluating the merits and risks of the
investment in the Shares; (ii) JHU is acquiring the Shares for its own account
for investment only and with no present intention of distributing any of the
Shares or any arrangement or understanding with any other persons regarding the
distribution of the Shares; (iii) JHU will not, directly or indirectly, offer,
sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy,
purchase or otherwise acquire or take a pledge of) any of the Shares except in
compliance with this Agreement, the Securities Act, applicable state securities
laws and the respective rules and regulations promulgated thereunder, and
acknowledges that certificates evidencing the Shares will be imprinted with a
legend that prohibits their transfer except in accordance therewith; and
(iv) JHU has, in connection with its decision to invest in EXACT relied only
upon the SEC Documents and the representations and warranties of EXACT contained
herein. JHU understands that its acquisition of the Shares has not been
registered under the Securities Act or registered or qualified under any state
securities law in reliance on specific exemptions therefrom, which exemptions
may depend upon, among other things, the bona fide nature of each investor’s
investment intent as expressed herein.

 

4.               Except as expressly modified herein, the Agreement and all of
its terms and conditions shall continue in full force and effect and both
parties agree and acknowledge that as of the date of signature below both
parties are in compliance with the terms of the Agreement.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this Amendment as of the date first above written.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

EXACT SCIENCES CORPORATION

 

THE JOHNS HOPKINS UNIVERSITY

 

 

 

By:

/s/ Don Hardison

 

By:

 /s/ Glen L. Steinbach

 

 

 

 

 

Printed Name:

Don Hardison

 

Printed Name:

Glen L. Steinbach

 

 

 

 

 

Title:

President and CEO

 

Title:

Senior Director, Admin.

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

FIFTH AMENDMENT TO LICENSE AGREEMENT BETWEEN

EXACT SCIENCES CORPORATION

AND

THE JOHNS HOPKINS UNIVERSITY

 

This Fifth Amendment (this “Amendment”) is made effective as of October 17,
2008, by and between The Johns Hopkins University (“JHU”) and EXACT Sciences
Corporation (“EXACT”).

 

WHEREAS, JHU and EXACT entered into an amended and restated license agreement
(the “Agreement”) having a final signature date of March, 25, 2003 (the
“EFFECTIVE DATE”);

 

WHEREAS, JHU and EXACT amended the Agreement on November 9, 2004, May 11, 2006
and March 19, 2007; and

 

WHEREAS, the parties desire to further amend certain provisions of the
Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties agree to the following amendments to the
Agreement, to be effective as of the date of execution of this Amendment:

 

1.               Sections 1.12.1(a) and 1.12.2(a) of the Agreement are hereby
replaced in their entirety with the following:

 

“[********]; and”

 

The parties hereby agree that all references, express or implied, to the
[********] minimum license fee set fort in the Agreement shall, instead, be
amended to reference [********] and any calculations set forth in the Agreement,
for purposes of example, shall be deemed illustrative only to the extent
appropriate based on the change in minimum annual fee from [********] to
[********] as set forth above.   In the event the BEAMING OPTION is exercised,
an additional [********] shall be included in the annual license fee.

 

2.               JHU hereby grants to EXACT an exclusive option (the “BEAMING
OPTION”) to an exclusive license in the SECOND BEAMING EXCLUSIVE FIELD for the
minimum annual fee set forth in this Agreement.  The BEAMING OPTION shall
expire, if not exercised, [********]from the date of this Amendment.   EXACT may
exercise the BEAMING OPTION granted hereunder by providing to JHU, prior to the
end of the option period: (a) written Notice of its intent, and, (b) a written
statement satisfactory to JHU, of its plans and capabilities, including specific
diligence milestones, to develop a

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

product or service in the SECOND BEAMING EXCLUSIVE FIELD for public use or
benefit.

 

3.               The patent applications identified below  (hereinafter the
“BEAMING PATENT RIGHTS”) are hereby deemed included in Exhibit A of the
Agreement:

 

[********]

 

4.               BEAMING EXCLUSIVE FIELD, for purposes of the BEAMING PATENT
RIGHTS only, shall mean a screening assay on a stool sample for the purpose of
diagnosing or monitoring colorectal neoplasia or precancerous adenomas of the
colon or rectum.

 

5.               BEAMING NONEXCLUSIVE FIELD, for purposes of the BEAMING PATENT
RIGHTS only, shall mean a screening assay on a blood sample for the purpose of
detecting colorectal neoplasia or precancerous adenomas of the colon or rectum.

 

6.               SECOND BEAMING EXCLUSIVE FIELD, for purposes of the BEAMING
PATENT RIGHTS only, shall mean a test on plasma, serum or a blood sample for the
purpose of detecting fetal trisomy 21 and fetal trisomy 18.

 

7.               The following Sections 2.1.1. and  2.1.2. are hereby deemed a
part of the Agreement:

 

2.1.1. Grant.  Subject to the terms and conditions of the Agreement, and
expressly subject to Article 2.3 therein, JHU hereby grants to COMPANY an
exclusive license under the BEAMING PATENT RIGHTS in the BEAMING EXCLUSIVE FIELD
to make, have made, use, have used, sell, have sold, import, and have imported
any method, service or product worldwide.

 

2.1.2. Grant.  Subject to the terms and conditions of the Agreement, and
expressly subject to Article 2.3 therein, JHU hereby grants to COMPANY a
non-exclusive license under the BEAMING PATENT RIGHTS in the BEAMING
NONEXCLUSIVE FIELD to make, have made, use, have used, sell, have sold, import,
and have imported any method, service or product worldwide.

 

8.               COMPANY shall initially have the sole and exclusive right, but
not the obligation to initiate and carry on legal proceedings, at COMPANY’s sole
expense and in JHU’s and HHMI’s name, if so required by law, against any
infringer or alleged infringer of any patent or patent application within
BEAMING PATENT RIGHTS within the BEAMING EXCLUSIVE FIELD only.  Such right shall
include the right to bring suit and collect damages for past infringement of any
patent within the BEAMING PATENT RIGHTS in the BEAMING EXCLUSIVE FIELD. COMPANY
shall control all aspects of any such proceeding, including, without limitation,
the strategy, defense, and settlement of such proceeding, and shall do so in a
manner consistent with the terms and provisions hereof. 

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

Subject to Paragraph 4.8, any damage, cost, award, fee, recovery, or
compensation paid by any third party in connection with any proceeding initiated
or carried on at COMPANY’S expense (whether by way of settlement or otherwise)
shall be retained by the COMPANY. The COMPANY shall not enter into any
settlement, consent judgment, or any other voluntary final disposition of any
infringement action under this Paragraph  without the prior written consent of
JHU, which shall not be unreasonably withheld, conditioned or delayed. 
Company’s right to sue for infringement hereunder shall not be used in an
arbitrary or capricious manner.

 

9.               The following Section 9.5 is hereby deemed a part of the
Agreement:

 

9.5  Termination of License to BEAMING PATENT RIGHTS Only.   EXACT may, at its
discretion, terminate its license with respect to the BEAMING PATENT RIGHTS
only, upon thirty (30) days written notice to JHU.  Under such circumstances,
EXACT shall no longer be responsible for patent prosecution and maintenance
costs related to the BEAMING PATENT RIGHTS and the Annual License Fee due from
EXACT to JHU shall be reduced by [********] ([********] if the SECOND BEAMING
EXCLUSIVE FIELD is included in the license) as of the immediately upcoming
annual payment date.  EXACT shall not be entitled to a refund of any amounts
previously owed to JHU, regardless of when EXACT exercises its rights under this
provision.

 

10.         Except as expressly modified herein, the Agreement and all of its
terms and conditions shall continue in full force and effect.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this Amendment as of the date first above written.

 

EXACT SCIENCES CORPORATION

 

THE JOHNS HOPKINS UNIVERSITY

 

 

 

By:

/s/ Jeffrey R. Luber

 

By:

/s/ Wesley D. Blakeslee

 

 

 

 

 

Printed Name:

Jeffrey R. Luber

 

Printed Name:

Wesley D. Blakeslee

 

 

 

 

 

Title:

President and CEO

 

Title:

Executive Director

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

SIXTH AMENDMENT TO LICENSE AGREEMENT BETWEEN

EXACT SCIENCES CORPORATION

AND

THE JOHNS HOPKINS UNIVERSITY

 

This Sixth Amendment (this “Amendment”) is made effective as of October 30,
2008, by and between The Johns Hopkins University (“JHU”) and EXACT Sciences
Corporation (“EXACT”).

 

WHEREAS, JHU and EXACT entered into an amended and restated license agreement
(the “Agreement”) having a final signature date of March 25, 2003 (the
“EFFECTIVE DATE”); and

 

WHEREAS, JHU and EXACT amended the Agreement on November 9, 2004, May 11, 2006,
March 19, 2007, and October 17, 2008; and

 

WHEREAS, the parties desire to amend certain provisions of the Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties agree to the following amendments to the
Agreement, to be effective as of the date of execution of this Amendment:

 

1.               Sections 1.12.1(a) and 1.12.2(a) of the Agreement are hereby
replaced in their entirety with the following:

 

“[********]; and”

 

The parties hereby agree that all references, express or implied, to the
[********] minimum license fee set fort in the Agreement shall, instead, be
amended to reference [********] and any calculations set forth in the Agreement,
for purposes of example, shall be deemed illustrative only to the extent
appropriate based on the change in minimum annual fee from [********] to
[********] as set forth above.  The minimum annual fee shall be reduced to
[********].  Thereafter, the minimum annual fee shall be [********]
([********]if the SECOND BEAMING OPTION has been exercised).

 

2.               The patent applications identified below are hereby deemed
included in Exhibit A of the Agreement:

 

[********]

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

--------------------------------------------------------------------------------

 

3.               The Field, for purposes of the above patents only, shall be
FECAL BASED TESTS, that is, a screening assay conducted on a stool sample for
the purpose of diagnosing colorectal neoplasia.

 

4.               Section 10.6 of the Agreement is hereby replaced in its
entirety with the following:

 

10.6                Notice.  All notices or communication required or permitted
to be given by either party hereunder shall be deemed sufficiently given if
mailed by registered mail or certified mail or sent by overnight courier, such
as Federal Express, to the other party at its respective address set forth below
or to such other address as one party shall give notice of to the other from
time to time hereunder.  Mailed notices shall be deemed to be received on the
third business day following the date of mailing.  Notices sent by overnight
courier shall be deemed received the following business day.

 

If to Company:

 

Exact Sciences Corporation

 

 

100 Campus Drive

 

 

Marlborough, MA  01752

 

 

Attn: President

 

 

 

If to JHU:

 

Johns Hopkins Technology Transfer

 

 

The Johns Hopkins University

 

 

100 N. Charles Street

 

 

5th Floor

 

 

Baltimore, MD 21201

 

 

Attn: Director

 

5.               Except as expressly modified herein, the Agreement and all of
its terms and conditions shall continue in full force and effect.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this Amendment as of the date first above written.

 

EXACT SCIENCES CORPORATION

 

THE JOHNS HOPKINS UNIVERSITY

 

 

 

By:

/s/ Jeffrey R. Luber

 

By:

/s/ Wesley D. Blakeslee

 

 

 

 

 

Printed Name:

Jeffrey R. Luber

 

Printed Name:

Wesley D. Blakeslee

 

 

 

 

 

Title:

President and CEO

 

Title:

Executive Director

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

 

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