Exhibit 10.25

 

CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION.  CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR SUCH
PORTIONS.  ASTERISKS DENOTE OMISSIONS.

 

LICENSE AGREEMENT

 

This License Agreement (“Agreement”) made this 26th day of July, 2010 (the
“Effective Date”), by and between Oncomethylome Sciences, S.A. (“Onco”), having
its principal office at Tour 5 GIGA niveau +3, Av. de I’Hopital 11, 4000 Liege,
Belgium, and Exact Sciences Corporation (“Exact”), having its principal place of
business at 441 Charmany Drive, Madison, WI 53719.

 

RECITALS

 

A.                                    Onco has exclusive rights to certain
issued and pending patents related to the use of certain methylation markers for
detection of cancer in fecal samples.

 

B.                                    Exact desires to obtain an exclusive
license to such patents and know-how within a specified field upon the terms and
conditions set forth in this Agreement.

 

NOW, THEREFORE, for good and valuable consideration, receipt and sufficiency of
which is hereby acknowledged, the parties agree as follows.

 

1.                                      Definitions.

 

1.1                               “Affiliate” means any corporation or other
entity that controls, is controlled by, or is under common control with, a
party.  A corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls more than
50% of the voting securities or other ownership interest of the other
corporation or entity or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the corporation
or other entity.

 

1.2                               “Complete Kit” means an in vitro diagnostic
kit that (i) is labeled so as to clearly identify Exact as the manufacturer
and/or sole producer of the product, in accordance with other comparable Exact
products, if any, sold by Exact directly to Third Parties and (ii) incorporates
all reagents and materials as are necessary to perform each assay from sample
receipt through generation of results, including sample preparation, isolation
of nucleic acid sequences and bisulfate treatment.

 

1.3                               “Complete Service” means the performance of a
Licensed Service by Exact from sample receipt through reported results,
including all steps and activities necessary to perform each assay, such as
sample preparation, isolation of nucleic acid sequences and bisulfate
treatment, etc.

 

1.4                               “Confidential Information” means any
documents, materials or information of a proprietary or non-public nature about
or held by a party.  For purposes of this Agreement, Confidential Information
shall not include information that:  (1) is generally known to the public at the
time of disclosure or becomes generally known through no wrongful act on the
part of the receiving party; (2) is in the receiving party’s possession without
obligation of confidentiality at the time of disclosure (as can be documented by
written records) other than as a result of receiving party’s

 

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breach of any legal obligation or a prior confidential disclosure by or on
behalf of the disclosing party; (3) becomes known to the receiving party through
disclosure by sources other than the disclosing party which sources have the
legal right to disclose such Confidential Information and which are under no
obligation of confidentiality (either direct or indirect) to the disclosing
party which respect to such Confidential Information; or (4) is independently
developed by the receiving party without reference to or reliance upon the
Confidential Information (as can be documented by written records).

 

1.5                               “Distributor” means a Third Party appointed by
Exact to distribute, market and/or sell Licensed Products to End Users for use
in the Licensed Field in accordance with this Agreement.

 

1.6                               “End User” means:  (i) with respect to
Licensed Products, a hospital, clinic, physician, laboratory or other Third
Party (but excluding a Distributor) which itself uses a Licensed Product for
analysis of samples obtained from individuals; and (ii) with respect to Licensed
Services, a physician, clinic or hospital who receives test results from Exact
or its Affiliates.

 

1.7                               “FDA Approval” means approval by the U.S. Food
and Drug Administration or its successor (the “FDA”) necessary for the
distribution, marketing, promotion, use or sale of Licensed Product in the U.S.
that is not conditioned on any other event (or if an approval is conditioned
upon an event, then the occurrence of that event), provided, however, such other
events shall specifically not include FDA requirements to conduct post marketing
studies and any requirement for such post marketing studies shall not be deemed
to delay the FDA Approval.

 

1.8                               “FDA Trial” means a prospective, controlled
human clinical trial sponsored by Exact the results of which are intended for
use in submission(s) for FDA Approval of a Licensed Product.

 

1.9                               “Improvement” means any issued or pending
patent first conceived or reduced to practice (whether actually or
constructively) by or otherwise acquired by Exact or its Affiliate(s) during the
Term, (a) which claims an invention that cannot be practiced without infringing
a claim of the Licensed Patents, or (b) which includes a claim that prevents the
practice of any invention within the scope of a claim of the Licensed Patents;
all to the extent that it has, or may acquire, the right to grant licenses,
immunities, or other rights thereunder.

 

1.10                        “Licensed Patents” means the Onco Methylation Marker
Patent Rights and the MSP Patent Rights.  The Licensed Patents cover Onco
Methylation Markers and MSP, as designated on Exhibits A and B, respectively.

 

1.11                        “Licensed Field” means in vitro diagnostic (“IVD”)
testing of fecal samples for detection of colorectal cancer and colorectal
pre-cancer.  For avoidance of doubt, the Licensed Field:  (i) includes both IVD
kits worldwide and lab developed tests offered in the U.S., on samples collected
in the U.S., performed at Exact’s own

 

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CLIA laboratories; and (ii) expressly excludes the Theranostics Field, the
Scientific Research Field, clinical trial testing of or in relation to any
therapeutic product that is commercialized or in clinical development, and
clinical trial testing services for any therapeutic, diagnostic or other
product.

 

1.12                        “Licensed Product” means a Complete Kit intended for
use in the Licensed Field which, but for the licenses granted under this
Agreement, would infringe a claim of a Licensed Patent (infringement shall
include direct, contributory, or inducement to infringe).

 

1.13                        “Licensed Service” means commercial laboratory-based
service testing intended for use in the Licensed Field which, but for the
licenses granted under this Agreement, would infringe a claim of a Licensed
Patent (infringement shall include direct, contributory, or inducement to
infringe).

 

1.14                        “MSP” means methylation specific polymerase chain
reaction (PCR), as covered by claims in the patent family U.S. 5,786,146 et seq.
and any corresponding foreign patents or patent applications.

 

1.15                        “MSP Patent Rights” means the issued patents and
patent applications listed on Exhibit B attached hereto and any renewals,
divisions, continuations, extensions or reissues based thereof, and
continuations-in-part to the extent the claims of the continuation-in-part are
supported by the disclosure in the parent application and any new matter added
to the continuation-in-part is unencumbered by a Third Party and supports the
claims of the parent application, and any corresponding foreign patent
applications, and any patents, patents of addition or other equivalent foreign
patent rights issuing, granted or registered thereon.

 

1.16                        “Net Sales” means the gross amount invoiced, billed
or received by or on behalf of Exact and its Affiliates on account of the sale
of a Licensed Product, and the gross the amount received by Exact and its
Affiliates on account of the performance or sale of a Licensed Service, in each
case in any bona fide, arms-length transactions with Third Parties, less the
following items, determined in accordance with Exact’s standard accounting
methods as generally and consistently applied, to the extent not already
reflected or deducted:  (i) discounts allowed and taken, not to exceed amounts
customary in the trade; (ii) sales taxes, use taxes and duties, including
import, export and excise duties imposed (but excluding income or value added
taxes); and (iii) solely with regard to Licensed Products, (x) freight and
insurance to the extent separately invoiced to and paid by the purchaser of such
Licensed Product; (y) credits for returns, allowances or trades, actually
granted, and (z) the gross amount invoiced, billed or received for any sample
collection components included with or in a Complete Kit; provided that if such
amount exceeds the lesser of six dollars ($6) or four percent (4%) of the gross
amount invoiced, billed or received for the applicable Complete Kit, then any
such excess shall be included in Net Sales.  For purposes of determining Net
Sales, with regard to Licensed Products, “sale” or “sold” shall mean the sale,
transfer, exchange, or other disposition of Licensed Products whether by gift or
otherwise, including the use of

 

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the Licensed Patents and/or Licensed Products by Exact or any other person
authorized by Exact.  Sales of Licensed Products shall be deemed consummated
upon the first to occur of:  (a) delivery of product, (b) receipt of payment
from the purchaser; and (c) sixty (60) days after invoicing the purchaser.

 

(a)                                 Sales to Distributors shall be considered
bona fide, arms-length transactions to Third Parties to the extent that such
Distributor purchases its requirements of such Licensed Products from Exact or
its Affiliates at fair market value for resale and/or distribution, but does not
otherwise make any royalty payment, or give any other consideration (in whatever
form, including barter of property, lump sums payments, marketing, distribution,
option or milestone payments, or any premium/discount paid over fair market
value for securities), to Exact or its Affiliates, directly or indirectly, with
respect to the Licensed Products or the intellectual property rights controlled
by Exact or its Affiliates with respect to such Licensed Products or the
Licensed Patents.

 

(b)                                 Net Sales with respect to sales in
non-arms-length transactions will be computed as follows:  (i) for sales to
Distributors, Net Sales shall be based on the gross amount invoiced, billed, or
received by or on behalf of Distributor on account of the sale of Licensed
Products to End Users in any bona fide, arms-length transaction (less the
reductions permitted above under this Section 1.16); or (ii) for sales to all
other Third Parties, at the average price of sale by Exact to End Users during
the preceding three-month period; or, if no sale to an End User has yet
occurred, at the non-discounted list price for the Licensed Product sold
directly by Exact.  In the event that no list price has been established, the
Parties shall negotiate, in good faith, other means of calculating Net Sales
with respect to such Licensed Product.

 

1.17                        “Onco Methylation Marker” means the methylation
markers FOXE1, SYNE1, NDRG4 and TFPI2, as further described in the Onco
Methylation Marker Patent Rights identified on Exhibit A; provided that, from
and after the notice delivered by Exact pursuant to Section 2.5, at most two out
of such four listed markers will continue as Onco Methylation Markers hereunder.

 

1.18                        “Onco Methylation Marker Patent Rights” means issued
patents and patent applications listed on Exhibit A attached hereto and any
renewals, divisions, continuations, extensions or reissues based thereof, and
continuations-in-part to the extent the claims of the continuation-in-part are
supported by the disclosure in the parent application and any new matter added
to the continuation-in-part is unencumbered by a Third Party and supports the
claims of the parent application, and any corresponding foreign patent
applications, and any patents, patents of addition or other equivalent foreign
patent rights issuing, granted or registered thereon; in each case to the extent
that such patent or other right contains a claim that covers, and solely to the
extent that any such claim covers, an Onco Methylation Marker(s); provided,
however, that the method claims contained in the

 

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patent application titled “Improved Methods of Detecting Colorectal Cancer”
(priority date 03-Feb-09) on Exhibit A (and the inventions disclosed and claimed
therein) are expressly excluded to the extent that they relate to or cover the
combination of (i) detection of epigenetic modification with (ii) detection of
blood in samples.

 

1.19                        “Primary Onco Methylation Marker” means, with
respect to a Licensed Product or Licensed Service, the use of an Onco
Methylation Marker in such Licensed Product or Licensed Service, respectively,
in which Vimentin is not used.

 

1.20                        “Royalty Base” means:  (i) for sales of a Licensed
Product or Licensed Service which utilizes one or more Onco Methylation
Marker(s) but not MSP, [***] of Net Sales attributable to such Licensed Product
or Licensed Service, respectively, and (ii) for sales of a Licensed Product or
Licensed Service which includes one or more Onco Methylation Marker(s) and MSP,
[***] of Net Sales attributable to such Licensed Product or Licensed Service,
respectively.

 

1.21                        “Scientific Research Field” means (i) scientific
research, including, any in vitro or in vivo research studies directed to
understanding biological sciences, high throughput screening and screening for
new genetic targets for genetic polymorphisms or product development, and
biomedical research directed to the identification and discovery of genetic
targets for therapeutic or diagnostic purposes; and (ii) commercial research
products and services, including any research use reagents and other research
products marketed or commercialized for any specified use of the analysis
results, disease indication, marker, marker set or application.

 

1.22                        “Supplementary Onco Methylation Marker(s)” as used
herein in either singular or plural, means, with respect to a Licensed Product
or Licensed Service, any Onco Methylation Marker used in such Licensed Product
or Licensed Service, respectively, in which Vimentin is also used, and/or the
second Onco Methylation Marker in such Licensed Product or Licensed Service,
respectively, when more than one Onco Methylation Marker is used.

 

1.23                        “Term” has the meaning set forth in Section 9.1
below.

 

1.24                        “Theranostics Field” means the field of using and
obtaining information from genetic and/or epigenetic and/or related tests to
predict or determine patient prognosis or response to therapeutics, therapeutic
procedures and/or other therapeutic medical treatments in oncology, including
(a) treatment methods, processes and techniques concerning the use and
administration or the appropriate dosage of therapeutics and monitoring of
cancer recurrence and (b) the choice between or among therapeutic treatment
options ( including predicting or determining the safety and/or toxicity of a
given therapeutic treatment).

 

1.25                        “Third Party” means any entity or person other than
Onco or any of its Affiliates, or Exact or any of its Affiliates.

 

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2.                                      Licenses.

 

2.1                               Onco hereby grants to Exact a royalty-bearing,
exclusive, non-sublicensable and non-transferable (except as expressly provided
in this Agreement) right and license under the Onco Methylation Marker Patent
Rights to:

 

(a)                                 make, have made, use, sell and have sold
Licensed Products in the Licensed Field worldwide; and

 

(b)                                 perform Licensed Services in the Licensed
Field in the United States and its territories (the “U.S.”) at Exact’s
laboratory(ies), on samples collected in the U.S.

 

2.2                               Onco hereby grants to Exact a royalty-bearing,
non-exclusive, non-sublicensable and non-transferable (except as expressly
provided in this Agreement) right and license under the MSP Patent Rights to:

 

(a)                                 make, have made, use, sell and have sold
Licensed Products in the Licensed Field worldwide; and

 

(b)                                 perform Licensed Services in the Licensed
Field in the U.S. at Exact’s laboratory(ies), on samples collected in the U.S.;

 

in each case, solely to the extent necessary for Exact to practice the Onco
Methylation Marker Patent Rights under Section 2.1.

 

2.3                               Each of the rights and licenses granted in
Sections 2.1 and 2.2 are subject to the following:

 

(a)                                 The right to “have made” includes only the
right to have Licensed Products manufactured through Exact’s toll manufacturers
for Exact’s sole benefit, and will not be exercised in any manner that is for
the purpose of avoiding the restrictions on sublicensing set forth in Sections
2.1 and 2.2.

 

(b)                                 The right to “have imported”, “have
marketed” and “have sold” includes only the right for a Distributor to import,
market and/or sell Licensed Products, and will not be exercised in any manner
that is for the purpose of avoiding the restrictions on sublicensing set forth
in Sections 2.1 and 2.2.  Any such grant of rights to a Distributor is further
subject to the following conditions:  (i) such grant shall be pursuant to a
written distribution agreement that contains terms and conditions that are not
inconsistent with those contained in this Agreement; and (ii) such distribution
agreement shall expressly exclude the grant of any license or rights under the
Licensed Patents to manufacture, modify, duplicate, repackage, re-label or
otherwise copy or reproduce any of the Licensed Products purchased by such
Distributor for resale to End Users (iii) neither the proposed Distributor nor
its Affiliates are involved, to Exact’s actual knowledge at the time such
distribution agreement becomes effective, in any material litigation or

 

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adversarial proceedings with Onco or its Affiliates regarding the Licensed
Patents or the subject matter of this Agreement.  Exact shall take reasonable
efforts to enforce the terms of such distribution agreements with the
Distributors.

 

(c)                                  The grants in Sections 2.1 and 2.2 are
subject to the rights retained by the United States government in accordance
with P.L. 96 517, as amended by P.L. 98-620; the rights, claims, and
limitations, if any, granted to the government of the United States of America
as set forth at 35 U.S.C. § 200 et seq., and 37 C.F.R. § 401 et seq., or similar
regulations of any competent governmental authority; and the rights of The Johns
Hopkins University (“JHU”) under the Master Licenses (as defined below) to make,
have made, provide, and use, for the purposes of JHU, The John Hopkins Health
System or any affiliate thereof, the JHU patent rights, including the ability to
distribute any biological material covered under the JHU patent rights for
nonprofit academic research use to non-commercial entities as is customary in
the scientific community.

 

Except for the rights and licenses explicitly granted in Sections 2.1 and 2.2,
no right, title or interest in or to the Licensed Patents, any inventions,
methods, processes, designs or other matters subject to the Licensed Patents is
granted, assigned or otherwise transferred to Exact pursuant to or by virtue of
this Agreement or by implication, estoppel or otherwise.

 

2.4                               The rights and licenses grant in this
Article 2 shall apply to any Affiliate of Exact.  If any Affiliate of Exact
exercises rights under this Agreement, such Affiliate shall be bound by all
terms and conditions of this Agreement, including indemnity and insurance
provisions and royalty payments, which shall apply to the exercise of the
rights, to the same extent as would apply had this Agreement been directly
between Onco and the Affiliate.  In addition, Exact shall remain fully liable to
Onco for all acts and obligations of Affiliate such that acts of such Affiliate
shall be considered acts of the Exact.

 

2.5                               Exact shall provide written notice to Onco no
later than December 31, 2010, specifying:  (i) which Onco Methylation Markers it
intends to use in Licensed Products and Licensed Services, provided that the
total number selected may not exceed two (2) in the aggregate, and (ii) whether
it intends to (a) utilize MSP in both its Licensed Products and Licensed
Services or (b) not utilize MSP in either.  Upon the date of such notice, the
Onco Methylation Marker Patent Rights for the Onco Methylation Markers which
Exact does not elect to utilize, and the MSP Patent Rights if Exact does not
elect to commercialize MSP, shall no longer be included in the rights and
license grants under this Agreement.  In the event that such notice is not
timely or properly delivered, this Agreement shall automatically terminate as of
January 1, 2011, without further action or notice by either party.

 

2.6                               Exact shall use reasonable best efforts to
develop, introduce into the commercial market, and continue to commercialize
Licensed Products and Licensed Services in

 

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the Licensed Field, consistent with FDA guidance and sound and reasonable
business practice and judgment, and with the goal of maximizing the returns to
both Exact and Onco from the activities undertaken pursuant to this Agreement. 
Without limiting the generality of the first sentence of this Section 2.6, Exact
shall satisfy each of the following milestones (each a “Milestone”):

 

(a)                                 Exact shall commence an FDA trial of a
Licensed Product prior to January 1, 2012; provided that Exact may extend such
deadline to January 1, 2013 with a payment of seventy-five thousand dollars
($75,000) to Onco on or prior to January 2, 2012.

 

(b)                                 Exact shall complete the first commercial
sale of an FDA-approved Licensed Product on or before the date that is the
earlier of (i) 32 months from the commencement of the first FDA Trial,
(ii) three months from FDA Approval, or (iii) December 1, 2015.

 

Without limiting Article 9, in the event Exact fails to achieve a Milestone,
Onco shall have the right to terminate this Agreement as its sole remedy for
Exact’s failure to achieve such Milestone.

 

3.                                      Royalties; Milestone Payments.

 

3.1                               Upon execution of this Agreement by both
parties, Exact shall pay Onco a non-refundable, non-creditable license fee of
one hundred thousand dollars ($100,000).  In the event Exact notifies Onco
Pursuant to Section 2.5 that it intends to utilize MSP, Exact shall pay Onco an
additional non-refundable, non-creditable license fee of one hundred thousand
dollars ($100,000) on the date of such notice.

 

3.2                               Exact shall pay Onco a minimum annual royalty
fee equal to one hundred thousand dollars ($100,000) within thirty (30) days
following the first and each subsequent anniversary of the Effective Date;
provided that Exact may temporarily defer the date of payment of such annual
minimum royalty fees until the commencement of the second calendar year
following the year in which Exact makes the first commercial sale of an
FDA-approved Licensed Product, such aggregate deferred fees to be subject to a
credit for milestone fees and royalties actually paid prior to such second
calendar year.  Thereafter (i.e. from and after the commencement of such second
calendar year), milestone payments accrued tinder Section 3.3 and running
royalties accrued under Section 3.4, in each case only to the extent paid to
Onco during the one year period preceding an anniversary of the Effective Date,
shall be credited against the minimum annual royalty fee due on that anniversary
date; provided, however that, except as specified in the first sentence of this
Section, no payment shall be carried forward or credited against royalties
payable for any other calendar period or credited against any other amounts due
(and no payment amounts shall be credited more than once against the same
royalty amount).

 

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3.3                               Exact shall pay Onco the following milestone
payments, payable within forty-five (45) days following the occurrence of the
applicable milestone:

 

(a)                                 Upon first commercial sale of a Licensed
Product after receipt of FDA Approval:  (i) one hundred thousand dollars
($100,000) if such Licensed Product incorporates Onco Methylation Markers but
not MSP; or (ii) two hundred thousand dollars ($200,000) if such Licensed
Product incorporates Onco Methylation Markers and MSP.

 

(b)                                 Upon reaching total aggregate Net Sales of
ten million dollars ($10,000,000) for Licensed Products and Licensed Services
which include Onco Methylation Markers but not MSP:  one hundred fifty thousand
dollars ($150,000).  Upon reaching total sales of ten million dollars
($10,000,000) for Licensed Products and Licensed Services which include Markers
and MSP:  three hundred thousand dollars ($300,000).

 

(c)                                  Upon reaching total aggregate Net Sales for
Licensed Products and Licensed Services of fifty million dollars ($50,000,000): 
seven hundred and fifty thousand dollars ($750,000).

 

(d)                                 Upon reaching total aggregate Net Sales for
Licensed Products and Licensed Services of fifty million dollars ($50,000,000)
in a single calendar year:  one million dollars ($1,000,000).

 

3.4                               Exact shall pay Onco a running royalty on Net
Sales, calculated against the Royalty Base, at the applicable royalty rates
determined based on the Onco Methylation Markers included in the Licensed
Product and/or Licensed Service and the rights to MSP, as follows:

 

(a)                                 In the event that Exact elects to
discontinue its right and license to MSP in the notice provided by Exact
pursuant to Section 2.5, the royalty rate shall equal:

 

[***]%          of the Royalty Base if the applicable Licensed Product or
Licensed Service includes one Supplementary Onco Methylation Marker but no other
Onco Methylation Marker; or

 

[***]%           of the Royalty Base if the applicable Licensed Product or
Licensed Service includes two Supplementary Onco Methylation Markers; or

 

[***]%           of the Royalty Base if the applicable Licensed Product or
Licensed Service includes a Primary Onco Methylation Marker but no other Onco
Methylation Marker; or

 

[***]%          of the Royalty Base if the applicable Licensed Product or
Licensed Service includes a Primary Onco Methylation

 

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Marker and a Supplementary Onco Methylation Marker.

 

(b)                                 In the event that Exact elects to continue
its right and license to MSP in the notice provided by Exact pursuant to
Section 2.5, the royalty rate payable shall equal:

 

[***]%           of the Royalty Base if the applicable Licensed Product or
Licensed Service includes one Supplementary Onco Methylation Marker but no other
Onco Methylation Marker; or

 

[***]%           of the Royalty Base if the applicable Licensed Product or
Licensed Service includes two Supplementary Onco Methylation Markers; or

 

[***]%          of the Royalty Base if the applicable Licensed Product or
Licensed Service includes a Primary Onco Methylation Marker but no other Onco
Methylation Marker; or

 

[***]%           of the Royalty Base if the applicable Licensed Product or
Licensed Service includes a Primary Onco Methylation Marker and a Supplementary
Onco Methylation Marker.

 

(c)                                  Notwithstanding the foregoing in this
Section 3.4, for Net Sales attributable to sales to Distributors, each of the
foregoing rates in this Section 3.4 shall be increased by a factor of 1.5 (i.e.
1/(1-.335)).  An annual review of such factor will be conducted to adjust the
rate up or down as necessary based upon changes in the percentage of Distributor
net revenue received by Exact (i.e. the actual gross margin of the
Distributor(s)).

 

3.5                               Notwithstanding the foregoing provisions of
this Article 3 and without limiting the terms of Section 1.16, the following
payment conditions shall apply:

 

(a)                                 Exact will not pay a royalty for a
reasonable amount, consistent with prevailing industry practices, of transfers
(non-sale) of Licensed Products to a Third Party for evaluation purposes only,
provided that Exact does not receive any compensation or consideration, directly
or indirectly, with respect to such transfers;

 

(b)                                 Regardless of the number of Licensed Patent
claims covering a unit of the Licensed Product or Licensed Service, Exact shall
pay only one royalty with respect to that same unit.

 

(c)                                  Exact shall not pay a royalty on any sales
of Licensed Product between Exact and its Affiliates which are intended for
resale.

 

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4.                                      Royalty Payments, Reporting and Other
Obligations

 

4.1                               Royalty payments will be due quarterly within
thirty (30) days following the end of each calendar quarter with respect to Net
Sales during the preceding calendar quarter.  Each payment shall be accompanied
by a written report to Onco detailing the royalty calculation as specified in
Section 3.4, including the Net Sales and quantity of each Licensed Product sold
per country (shown separately for Distributor sales), the calculation of the
Royalty Base, and such additional detail as may be reasonably requested by Onco
(including information necessary to appropriately calculate its royalty
obligations under the Master Licenses), but in no event shall Exact be required
to disclose to Onco the name or contact information of any customer.

 

4.2                               Until Exact has achieved a first commercial
sale of an FDA-approved Licensed Product, Exact will provide on a semi-annual
basis to OMS (within forty-five (45) days of the end of each of the second and
fourth calendar quarters) a written report describing Exact’s diligent and good
faith efforts to develop and introduce Licensed Product into the commercial
market as soon as practicable, consistent with sound and reasonable business
practice and judgment.  Each such report will include without limitation,
(a) the nature and extent of the work completed to commercialize the Licensed
Product, (b) the product development, regulatory, reimbursement, marketing, and
commercialization plans and strategies to be implemented in the next quarter to
commercialize Licensed Product, and (c) an updated estimated date by which Exact
will first commercialize Licensed Product.

 

4.3                               Exact shall keep correct and complete books
and records containing all information required for the computation and
verification of the amounts to be paid hereunder.  At the request of Onco, Exact
shall permit an independent, certified public accountant selected and paid by
Onco upon reasonable notice, and upon the execution of Exact’s standard
confidentiality agreement, to have access during normal business hours to such
records as may be necessary to determine the correctness of any report and/or
payment made or payable pursuant to this Agreement.  Such accountant shall not
disclose to Onco any information related to the business or trade secrets of
Exact, except that which should properly have been contained in any report
hereunder.  Any information disclosed by the accountant to Onco shall not be
used for any purpose other than the verification of the royalty payments due
hereunder.  Onco shall bear the cost of the examination, unless such examination
reveals that Exact has underpaid Onco by an amount equal to or exceeding five
percent (5%) during any quarter, in which event Exact shall be responsible for
such costs.  As a condition to entering into any such agreement, Exact shall
include in any agreement with its Affiliates which permits such party to make,
use, sell or import the Licensed Products and/or Licensed Services, a provision
requiring such party to retain records of sales and other information as
required in Section 3.5 and permit Onco to inspect such records as required by
this Section.

 

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4.4                               Any payments to be made by Exact to Onco under
this Agreement shall be made without deduction of any bank or transfer charges. 
Onco shall pay any and all taxes levied on account of, or measured exclusively
by, all payments it receives under this Agreement.  Amounts payable under this
Agreement shall be paid by Exact without deduction for any tax or duty levied
outside Onco’s country (Belgium); provided, however, that Exact shall have the
right to withhold income tax (and other withholding tax) as required by
applicable tax laws.  In the case of such withholding being applicable, Onco may
apply for a reduced rate of withholding tax under any applicable tax treaty with
the reasonable assistance of Exact, and provided that evidence of acceptance of
this claim is submitted to Exact before payment is due, Exact shall apply the
reduced rate accordingly.  If applicable laws require that taxes be withheld,
Exact will deduct those taxes from the remittable payments, make timely payment
of the taxes to the proper taxing authority and send official receipts issued by
the appropriate taxing authority evidencing such payment to Onco promptly
following that payment.

 

4.5                               All references to monetary amounts in this
Agreement are in US dollars.  All payments under this Agreement shall be made in
Euros.  In the case of sales invoiced in a currency other than the Euro, the
rate of exchange to be used in computing the amount of currency equivalent in
Euros due Onco shall be calculated using Exact’s then-current standard exchange
rate methodology applied in its external reporting (which is ultimately based on
official, internationally recognized third-party rates such as the European
Central Bank) for the conversion of foreign currency sales, consistently
applied.  Checks are to be made payable to “ONCOMETHYLOME SCIENCES SA”.  Wire
transfers may be made through:

 

Wire info:
BANK:

ING Bank

 

Marnixlaan 24
B-1000 Brussels

SWIFT-Code:
Account No.:

BIC BBRUBEBB
BE89 3101 8015 8085

 

 

OncoMethylome Sciences, SA
Tour 5 GIGA
Avenue de I’Hopital 11
4000 Liege
 Belgium

 

 

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

 

4.6                               In the event that any payment due hereunder is
not made when due, the payment shall accrue interest beginning on the tenth day
following the due date thereof, calculated at the annual rate of the sum of
(a) two percent (2%) plus (b) the prime interest rate quoted by The Wall Street
Journal on the date said payment is due, the interest being compounded on the
last day of each calendar quarter, provided however, that in no event shall said
annual interest rate exceed the maximum legal

 

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interest rate.  Each such payment when made shall be accompanied by all interest
so accrued.  Said interest and the payment and acceptance thereof shall not
negate or waive the right of Onco to seek any other remedy, legal or equitable,
to which it may be entitled because of the delinquency of any payment including
termination of this Agreement as set forth in Section 9.3.

 

4.7                               To the extent commercially feasible and
consistent with prevailing business practices, Exact shall, and it will require
each of its Distributors to, mark all Licensed Products with the appropriate
patent information, consistent with the provisions of 35 U.S.C. 287.

 

4.8                               Neither Exact nor any of its Affiliates or
Distributors shall sell or otherwise transfer to any Third Party any Licensed
Products except pursuant to a label license requiring such party to use such
Licensed Product only in the Licensed Field and not for other purposes without
obtaining a separate license from Onco.  Onco shall be listed as a licensor in
such label license.  Onco and Exact shall agree in good faith on the specific
wording of such label license, the initial form of which has been agreed to
between the parties, as set forth on Exhibit C hereto.  The fact that the
Licensed Products are sold only under the label license shall be stated clearly
in Exact’s marketing materials, catalogs and the like.  Exact shall provide Onco
with samples of proposed packaging and marketing materials for Onco’s review and
approval solely with respect to the label license.  Exact will cooperate with
Onco and take all reasonable steps requested by Onco to ensure the
enforceability of the terms of the label license.  It is understood and agreed
that Onco is an intended beneficiary of the terms of the label license.  Exact
agrees, upon Onco’s request, to provide reasonable cooperation to assist Onco in
enforcing the terms of the label license, at Onco’s cost.

 

4.9                               In exercising the license granted tinder this
Agreement, Exact will comply with all applicable laws, rules, regulations,
orders and other requirements of any governmental authority having
jurisdiction.  Without limiting the generality of the foregoing, Exact will be
solely responsible for obtaining all governmental and regulatory approvals,
authorizations, licenses and permits necessary to manufacture, distribute,
market, sell, export and import the Licensed Products and Licensed Services.

 

4.10                        To the fullest extent permitted by applicable law,
neither Exact nor any of its Affiliates will contest or otherwise challenge
(e.g., in any legal action or otherwise), or assist or encourage any other
person or entity to contest or challenge, the validity of any of the Patent
Rights.  Without limiting or waiving any rights and remedies, legal or
equitable, available to Onco, Onco may terminate this Agreement immediately in
the event that Exact or any of its Affiliates institutes legal or other formal
proceedings contesting or otherwise challenging, or assists or encourages any
other person or entity to so contest or challenge, the validity of any of the
Patent Rights.  In the event that Exact becomes or is made aware that a
Distributor is contesting or otherwise challenging (e.g., in any legal action or
otherwise), or is assisting or encouraging any other person or entity to contest
or

 

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challenge, the validity of any of the Patent Rights, Exact shall promptly inform
Onco thereof in writing and Exact shall immediately terminate such agreement
and/or all distributorship rights with respect to Licensed Products.  Further,
each such distributorship agreement shall include a provision permitting Exact
to observe its obligations tinder this Section 4.10.

 

5.                                      Warranties

 

5.1                               Onco represents and warrants that:  (i) it has
exclusive rights in the Licensed Patents pursuant to the license agreements
described on Exhibit D (the “Master Licenses”) and has the power and authority
to grant the licenses provided for in this Agreement, (ii) that it has provided
Exact with true copies of the Master Licenses with reasonable redaction of
certain Confidential Information, including any and all amendments thereto,
(iii) that there has been no breach of any term or condition of the Master
Licenses, and (iv) during the Term, with regard to those Master Licenses that
are the subject of the rights licensed hereunder, it shall use commercially
reasonable efforts to maintain in full force and effect and fully perform its
obligations under such Master Licenses, it shall not exercise any right to
itself terminate such Master Licenses, it shall keep Exact frilly informed of
any notice of alleged breach it receives from JHU with respect to such Master
Licenses, and it shall not, without the prior written consent of Exact not to be
unreasonably withheld or delayed, amend or modify such Master Licenses if such
amendment or modification would materially adversely affect Exact’s rights or
benefits under this Agreement.

 

5.2                               Each party represents and warrants to the
other corporate party that:  (a) it is duly organized and validly existing and
in good standing, in each case, under the laws of the jurisdiction of its
incorporation; (b) it has full corporate power and authority to execute and
deliver this Agreement, and to perform its obligations and to grant the rights
granted and intended to be granted under this Agreement; (c) it has taken all
corporate action necessary to authorize the execution, delivery and performance
by it of this Agreement; (d) this Agreement constitutes a valid and binding
agreement of it enforceable against it in accordance with its terms; (e) the
execution and delivery of this Agreement and all other instruments and documents
required to be executed pursuant hereto, and the consummation of the
transactions contemplated hereby and thereby, do not and shall not (i) conflict
with or result in a breach of any provision of its organizational documents;
(ii) result in a breach of any material agreement to which it is a party; or
(iii) violate any law in any material respect expressly required by this
agreement to be complied with or, to its knowledge, violate any other law; and
(f) it shall comply with all laws, rules and regulations to the extent
applicable to its performance under this Agreement.

 

5.3                               EXCEPT AS EXPRESSLY PROVIDED IN THIS
ARTICLE 5, ONCO MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND TO EXACT, AND
ONCO EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER IMPLIED OR STATUTORY OR ARISING
OUT OF CUSTOM OR COURSE OF

 

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DEALING OR USAGE OF OR IN THE TRADE, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.

 

5.4                               THE LICENSED PATENTS ARE PROVIDED “AS IS” AND
NEITHER JHU, THE INVENTORS (AS DEFINED BELOW) NOR ONCO MAKE ANY REPRESENTATION
OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCTS, INCLUDING
THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY.  JHU, THE INVENTORS, AND
ONCO DISCLAIM ALL WARRANTIES WITH REGARD TO LICENSED PRODUCTS, INCLUDING ALL
WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY
PARTICULAR PURPOSE.  NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JHU,
THE INVENTORS, AND ONCO DISCLAIM ALL OBLIGATIONS AND LIABILITIES ON THE PART OF
JHU, THE INVENTORS AND ONCO, FOR DAMAGES, INCLUDING INDIRECT, SPECIAL, AND
CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF
JHU, THE INVENTORS, OR ONCO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES,
FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE,
MAINTENANCE, USE, OR SALE OF THE LICENSED PRODUCTS.  EXACT AND ITS AFFILIATES
ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A LICENSED
PRODUCT MANUFACTURED, USED, OR SOLD BY OR ON BEHALF OF EXACT OR ITS AFFILIATES.

 

5.5                               EXACT IS AWARE THAT IN ORDER TO PRACTICE ANY
OR ALL OF THE LICENSED PATENTS, IT MAY BE NECESSARY TO OBTAIN ADDITIONAL
LICENSES TO OTHER PATENTS OR INTELLECTUAL PROPERTY.  EXACT HAS HAD THE
OPPORTUNITY TO REVIEW OR HAS REVIEWED THE LICENSED PATENTS TO VERIFY THE
SUITABILITY OF THE LICENSED PATENTS FOR EXACT’s INTENDED PURPOSE AND IS NOT
RELYING ON ANY STATEMENTS OF ONCO WITH RESPECT TO THE FOREGOING.

 

5.6                               EXACT SHALL NOT MAKE ANY REPRESENTATION OR
WARRANTY TO THIRD PARTIES CONTRARY TO THE LIMITATIONS ON WARRANTIES AND
REPRESENTATIONS GIVEN BY ONCO.

 

5.7                               THE LIMITATIONS SET FORTH ABOVE IN THIS
ARTICLE 5 SHALL SURVIVE ANY EXPIRATION OR TERMINATION OF THIS AGREEMENT FOR ANY
REASON.

 

6.                                     Limitation of Liability and Remedies;
Indemnification; Insurance.

 

6.1                               NOTWITHSTANDING ANY OTHER PROVISION CONTAINED
IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES.  THE FOREGOING LIMITATIONS ARE
APPLICABLE NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE.  THE FOREGOING
LIMITATIONS

 

15

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SHALL NOT APPLY WITH RESPECT TO THE INDEMNITY OBLIGATIONS OF THE PARTIES AS SET
FORTH IN THIS ARTICLE 6.

 

6.2                               Exact shall defend, indemnify, and hold
harmless Onco and its employees, officers, and directors (herein “Onco
Indemnitees”) from and against any and all claims, demands, judgments, loss,
liability, expense, or damage (including investigative costs, court costs and
attorneys’ fees) (“Liability”) Onco Indemnitees may suffer, pay, or incur as a
result of any claims, demands or actions against any of the Onco Indemnitees,
regardless of the legal theory asserted, arising or alleged to arise out of or
in connection with Exact’s, its Affiliates’ or Distributors’ manufacture,
testing, design, use, sale, or labeling of any Licensed Products or Licensed
Services or any obligation, representation or warranty of Exact hereunder or any
breach by Exact of this Agreement, unless such Liability arises or is alleged to
arise out of or in connection with Onco’s negligence or willful misconduct or
breach of this Agreement, except to the extent covered by Onco’s indemnity
obligations under Section 6.4.  Exact’s obligations under this section shall
survive the expiration or termination of this Agreement for any reason.

 

6.3                               Distributive Chain Liability and Indemnity. 
Neither JHU nor the individuals listed as inventors of the inventions disclosed
in the claims of the JHU patent rights (the “Inventors”) shall have any control,
by this Agreement or otherwise, over the manner in which Exact or those
operating for its account or third parties who purchase Licensed Products or
Licensed Services from any of the foregoing entities, develop, manufacture,
market, or practice the inventions disclosed in the claims of the JHU patent
rights or the Licensed Products or Licensed Services.  Exact shall indemnify,
defend (with counsel reasonably acceptable to JHU, the Inventors, or Onco as
applicable), and hold harmless JHU, The Johns Hopkins Health Systems, their
present and former trustees, officers, agents, faculty, employees, and students,
the Inventors, against and from any judgments, fees, expenses, or other costs
arising from or incidental to any product liability based on use of the Licensed
Products whether or not JHU or the Inventors, either jointly or separately, are
named as a defendant in any such lawsuit and whether or not JHU or the Inventors
are alleged to be negligent or otherwise responsible for any injuries to persons
or property.  The obligation of Exact to indemnify, defend, and hold harmless in
this section shall survive the expiration or termination for any reason of this
Agreement, shall continue even after assignment of rights and responsibilities
to an Affiliate, and shall not be limited by any other limitation of liability
elsewhere in this Agreement.

 

6.4                               Onco shall defend, indemnify, and hold
harmless Exact and its employees, officers, and directors, (herein “Exact
Indemnitees”) from and against any and all Liability that Exact Indemnitees may
stiffer, pay, or incur as a result of any claims, demands or actions against any
of the Exact Indemnitees, regardless of the legal theory asserted, arising or
alleged to arise out of or in connection with Onco’s breach of this Agreement,
unless such Liability arises or is alleged to arise out of or in connection with
Exact’s negligence or willful misconduct, except to the extent covered by
Exact’s indemnity obligations under Section 6.2.  Onco’s obligations

 

16

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under this section shall survive the expiration or termination of this Agreement
for any reason.

 

6.5                               Whenever an indemnified party has information
from which it may reasonably conclude an incident has occurred which could give
rise to any Liability under this Article 6, such indemnified party shall
promptly give written notice to the indemnifying party of all pertinent data
surrounding such incident and, in the event a claim for Liability is made or
suit is brought, all indemnified parties shall assist the indemnifying party and
cooperate in gathering information and in investigating and defending such claim
or suit.  No indemnified party shall, except at its own cost, voluntarily make
any payment or incur any expenses in connection with any such claim for
Liability without the prior written consent of the indemnifying party.  In
addition, the indemnifying party may, at its sole discretion, and at its own
expense, carry out the sole management, defense and settlement of such claim or
suit, and shall provide attorneys of its sole choosing to defend against any
such claim or suit.

 

6.6                               Prior to the commencement of human clinical
trials and the manufacture or sale of a Licensed Product or the provision of a
Licensed Service, and at all times thereafter during the term of this Agreement
and for at least four (4) years following termination, Exact shall obtain and
maintain appropriate general liability and product liability insurance at an
overall level, incident level, and deductible amount as are standard in the
industry at such time (but in no case will the incident level be less than $5
million and the overall level be less than $5 million).  Such coverage(s) shall
be purchased from a carrier or carriers having an A.M.  Best rating of at least
A- (A minus) and shall name Onco as an additional insured.  Exact shall provide
to Onco a Certificate of Insurance evidencing compliance with this provision
prior to the commencement of manufacture or sale of any Licensed Product, and
shall thereafter provide to Onco evidence reasonably satisfactory to it that
such insurance continues to be maintained.  Exact is responsible for ensuring
that Onco is notified at least thirty (30) days prior to cancellation or
reduction in coverage of the foregoing Insurance.

 

7.                                      Patent Prosecution and Maintenance Fees:

 

7.1                               As between the parties, Onco shall retain sole
control of the prosecution and maintenance of all Licensed Patents, subject to
the rights retained by JHU tinder the Master Licenses.  Onco will use
commercially reasonable efforts to take, or to ensure that JHU takes, all
actions necessary to complete and pursue patent filings and issuance of patents,
and make all filings and paying all fees required for the maintenance of all
Licensed Patents.  Exact shall reimburse Onco for a portion of the foregoing
costs incurred during the Term equal to:  (i) seventy-five percent (75%) for
reasonable costs related to Onco Methylation Marker Licensed Patents which Exact
elects to license under this Agreement and (ii) ten percent (10%) for reasonable
costs related to MSP Licensed Patents which Exact elects to license tinder this
Agreement.

 

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7.2                               Subject to the rights retained by JHU under
the Master Licenses, Onco shall keep Exact fully informed regarding the
prosecution of the Licensed Patents, including:  a) any upcoming deadlines for
the patent filings, b) any decision not to file for patent protection; c) any
communication between a Onco patent agent/attorney and a patent office with
respect to Licensed Patents, pending applications, renewals, disputes and other
actions pertaining to Licensed Patents.  Onco shall give Exact reasonable access
to all documentation, filings and written communications to and from the
respective patent agents and patent offices.  Onco shall give due consideration
to all suggestions and comments of Exact regarding any aspect of patent
prosecution relating to the Licensed Patents.

 

7.3                               Subject to the rights retained by JHU under
the Master Licenses, if Onco, after reasonable notice to Exact, decides to
abandon a patent filing or decides not to pay maintenance fees in any particular
country, then Exact may maintain the patent or pay the maintenance fees (and any
payments made by Exact in connection with such application or maintenance shall
reduce dollar for dollar the royalty payments due and payable by Exact pursuant
to the terms of this Agreement for Net Sales in the applicable country; provided
that, in no event, shall the royalties payable to Onco be reduced by more than
fifty percent (50%) in a calendar quarter) and Onco shall abandon all and retain
no further rights in the patent or application.

 

8.                                      Enforcement of Licensed Patents.

 

8.1                               If either Onco or Exact knows of any actual or
threatened infringement or misappropriation by a Third Party of any Licensed
Patents in the Licensed Field, then that party shall notify the other party in
writing promptly of such actual or threatened infringement or misappropriation.

 

8.2                               Subject to the rights retained by JHU under
the Master Licenses, Exact shall have the first right to take legal action to
enforce the Licensed Patents in the Licensed Field by written notice to Onco no
later than sixty (60) days following the notice of infringement, in which event
Exact shall bear all of the costs of such enforcement and shall be entitled to
retain all proceeds recovered from the Third Party, provided that (i) Exact
shall pay out of such proceeds to Onco such amount as is actually required to be
passed through to JHU under the applicable provision(s) regarding recovery under
the Master Licenses and (ii) the net proceeds (i.e., total consideration
received by Exact from any Third Party less Exact’s costs in enforcing the
Licensed Patents) shall be considered Net Sales subject to the payment of
royalties to Onco.  In the event Exact does not elect to enforce the Licensed
Patents against the infringer, Onco may thereafter pursue such enforcement at
its expense and retain any proceeds of such action.

 

8.3                               Onco and Exact shall keep one another informed
of the status of and of their respective activities regarding any litigation or
settlement thereof concerning the Licensed Patents in the Licensed Field. 
However, if a suit is defended or action brought by a party, the party cannot
settle or consent to judgment or voluntarily dispose of the suit or action
without the consent of the other party (including JHU

 

18

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as and to the extent applicable); provided the consent is not unreasonably
withheld or delayed.

 

8.4                               If a party takes legal action pursuant to this
Article 8, then the other party shall fully cooperate and provide such
assistance as is reasonably requested.  Either party may participate in legal
action taken by the other with its own attorneys at its own expense.

 

9.                                      Term and Termination.

 

9.1                               Unless otherwise terminated in accordance with
any other provision of this Article 9, the term of this Agreement (the “Term’’),
as well as its obligations to pay royalties, shall commence on the Effective
Date and shall end on the date that all Licensed Patents have expired or are no
longer in effect.

 

9.2                               Exact may terminate this Agreement by
providing Onco with written notice at least ninety (90) days prior to the
expiration of the then current Term.

 

9.3                               This Agreement may be terminated by either
party in the event of a breach by the other party, upon not less than sixty (60)
days prior written notice, provided that such termination may not take place if
within such period the party in breach has remedied such breach.

 

9.4                               Termination of this Agreement for any reason
shall be without prejudice to any other remedies to which either party is or
thereafter becomes entitled hereunder and shall not affect any obligations or
rights accrued before termination hereunder or the provisions of this Agreement
which by their nature require performance following termination of this
Agreement shall survive the expiration or termination of this Agreement. 
Notwithstanding anything herein to the contrary, upon termination of this
Agreement for any reason, Exact shall immediately pay to Onco any accrued,
non-credited amounts that had been previously deferred under the terms of
Section 3.2.

 

9.5                              In the event that this Agreement is terminated
by Exact pursuant to Section 9.2 or by Onco for Exact’s breach pursuant to
Section 9.3, Exact shall and hereby does automatically grant to Onco a
worldwide, fully paid-up, irrevocable non-exclusive right and license, with
rights to sublicense through multiple tiers, under the Improvements solely as
and to the extent required by Onco to practice the Licensed Patents.

 

10.                               Miscellaneous

 

10.1                        Confidentiality.  Neither party, without the express
written consent of the other party, may disclose to third parties any
Confidential Information of the other party.  A breach in confidentiality shall
give the other party the right to immediately terminate this Agreement. 
Notwithstanding the foregoing, either party may disclose the Confidential
Information of the other party if required by law, regulation or subpoena to do
so, in which case the party making the disclosure shall

 

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provide the other party with prompt written notice of such requirement so that
the other party may seek confidential treatment of its Confidential Information,
and the party making the disclosure shall reasonably cooperate with such
efforts.

 

10.2                        Press Releases.  The parties agree to issue a
mutually agreed upon joint press release within twenty-fora- (24) hours of the
Effective Date, announcing this Agreement and the activities contemplated by
this Agreement, substantially in the form attached hereto as Exhibit E.  Onco
will be responsible for translating into a foreign language any press release
that is required or advisable to be issued in such language.  In addition, the
parties agree to issue a joint press release within twenty-four (24) hours of
the first announcement of clinical results on an assay that includes Onco
Methylation Marker(s).

 

10.3                        Use of Name.  Neither Exact nor its Affiliates or
Distributors shall use the name of OncoMethylome Sciences or The Johns Hopkins
University (including The Johns Hopkins Health System or any of its constituent
parts, such as the Johns Hopkins Hospital or any contraction thereof or the name
of JHU inventors) in any advertising, promotional, sales literature or
fundraising documents without prior written consent from an authorized
representative of Onco.  Exact shall allow at least seven (7) business days
notice of any proposed public disclosure for Onco’s review and comment or to
provide written consent.  Neither OncoMethylome Sciences or The Johns Hopkins
University (including The Johns Hopkins Health System or any of its constituent
parts, such as the Johns Hopkins Hospital or any contraction thereof or the name
of JHU inventors) nor its affiliates shall use the name of Exact in any
advertising, promotional, sales literature or fundraising documents without
prior written consent from an authorized representative of Exact.

 

10.4                        Remedies.  The parties acknowledge that money
damages may not be an adequate remedy for any breach or threatened breach of any
of a party’s obligations tinder this Agreement involving intellectual property
or Confidential Information.  The parties therefore agree that in addition to
any other remedies available hereunder, by law or otherwise, either party will
be entitled to seek injunctive relief against any such breach or threatened
breach by the other party of such obligations.

 

10.5                        Assignment.  This Agreement will inure to the
benefit of, and be binding upon, the successor and assigns of both parties, but
no assignment by either party will have any force or validity whatsoever,
except, unless and until approved in writing by the other party, which approval
shall not be unreasonably withheld or delayed.  Notwithstanding the foregoing,
either party may assign its rights and obligations under this Agreement without
consent to a Third Party in connection with a merger or sale transaction
involving substantially all of the party’s assets relating to this Agreement;
provided, however, that any such assignment by Exact shall be subject to, as a
condition precedent to such assignment and/or delegation, the provision by the
Exact to Onco of (i) prior written notice of the assignment or delegation and
the name, address, and other contact information of the assignee, (ii) certified
copies of the organizational documents of the assignee, and (iii) a written
assumption

 

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agreement (reasonably satisfactory to Onco) signed by the assignee.  Any
purported assignment of rights or delegation of performance in violation of this
Section is void.  Despite any delegation, the delegating Party remains liable
for any performance it delegated.

 

10.6                        Governing Law and Venue.  This Agreement shall be
interpreted in accordance with the State of New York without reference to its
conflicts of laws provisions.

 

10.7                        Notice.  All notices or communications that either
party may desire, or be required, to give to the other will be in writing and
will be deemed to have been duly served if and when delivered by courier to such
address of the party appearing above, or to such other address as may be
specified by a party in a notice to the other.

 

10.8                        Entire Understanding.  This Agreement represents the
entire understanding between the parties, and supersedes all other agreements,
express or implied, between the parties concerning the subject matter hereof,
and is not subject to change or modification except by the execution of a
written instrument subscribed to by authorized representatives of the parties.

 

10.9                        Relationship of the parties.  Neither this Agreement
nor any activities of the parties pursuant to this Agreement shall be deemed to
establish any partnership, agency, joint development project or joint venture
between the parties.

 

10.10                 Headings; Interpretation.  The headings of the articles of
this Agreement are merely to facilitate reference and shall have no bearing on
the interpretation of any of the provisions of this Agreement.  Any reference in
this Agreement to any Article or Section refers to the corresponding Article or
Section of this Agreement.  Any reference in this Agreement to any Schedule or
Exhibit refers to the corresponding Schedule or Exhibit attached to this
Agreement and all such Schedules and Exhibits are incorporated herein by
reference.  All words in this Agreement will be construed to be of such gender
or number as the circumstances require.  The word “including” in this Agreement
means including without limitation.  All accounting terms not specifically
defined in this Agreement shall be construed in accordance with GAAP.  The word
“or” in this Agreement is disjunctive but not necessarily exclusive.  Words in
the singular in this Agreement include the plural and vice versa.

 

10.11                 Non-Waiver.  The failure of either party to exercise any
right hereunder or to insist upon performance of any of the terms or conditions
of this Agreement shall not be construed as a waiver or relinquishment of any
right to insist upon future performance of any such term or condition.

 

10.12                 Severability.  Invalidation of any one of the provisions
of this Agreement for any reason shall in no way affect any other provision
hereof, and all such other provisions shall remain in full force and effect.

 

10.13                 Attorneys’ Fees.  In the event of any action to enforce
this Agreement, the prevailing party in such action shall be entitled to
recover, in addition to all other

 

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relief, from the non-prevailing party (as determined by the decision maker in
such action) all attorneys’ fees and other costs and expenses incurred by the
prevailing party in connection with such action (including any appeal thereof).

 

10.14                 No Third Party Beneficiaries.  Except for the rights of
JHU as licensor of the Licensed Patents to Onco, no person who is not a party to
this Agreement (or a permitted successor or assignee) shall have any right to
enforce any term of this Agreement.

 

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

 

Exact Sciences Corporation  

 

Oncomethylome Sciences, S.A.  

 

 

 

 

 

 

By

/s/ Kevin T.Conroy

 

By

/s/ J. Groen

 

 

 

Name:

Kevin T. Conroy

 

Name:

J. Groen

 

 

 

Title:

CEO

 

Title:

CEO

 

 

 

Date:

7/27/2010

 

Date:

7/27/2010

 

22

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