Exhibit 10.3


 




 





AMENDED AND RESTATED LICENSE AGREEMENT


 


by and between


 


GENZYME CORPORATION


 


and


 


EXACT SCIENCES CORPORATION


 


(formerly EXACT LABORATORIES, INC.)


 


January 27, 2009




 





 


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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TABLE OF CONTENTS


 


	
   

  	
  Page

  
	
   

  	
   

  
	
  ARTICLE 1. DEFINITIONS

  	
  1

  
	
   

  	
   

  
	
  ARTICLE 2. LICENSE GRANT AND WAIVER

  	
  6

  
	
   

  	
   

  
	
  ARTICLE 3. DILIGENCE

  	
  7

  
	
   

  	
   

  
	
  ARTICLE 4. PAYMENTS

  	
  7

  
	
   

  	
   

  
	
  ARTICLE 5. REPORTS AND RECORDS

  	
  12

  
	
   

  	
   

  
	
  ARTICLE 6. PATENT PROSECUTION; INFRINGEMENT

  	
  13

  
	
   

  	
   

  
	
  ARTICLE 7. TERM AND TERMINATION

  	
  15

  
	
   

  	
   

  
	
  ARTICLE 8. INDEMNIFICATION AND INSURANCE

  	
  18

  
	
   

  	
   

  
	
  ARTICLE 9. REPRESENTATIONS, WARRANTIES AND DISCLAIMERS

  	
  21

  
	
   

  	
   

  
	
  ARTICLE 10. NOTICES

  	
  22

  
	
   

  	
   

  
	
  ARTICLE 11. ARBITRATION

  	
  23

  
	
   

  	
   

  
	
  ARTICLE 12. RESTRICTIONS ON USE OF NAMES

  	
  25

  
	
   

  	
   

  
	
  ARTICLE 13. CONFIDENTIALITY

  	
  25

  
	
   

  	
   

  
	
  ARTICLE 14. PATENT MARKING

  	
  26

  
	
   

  	
   

  
	
  ARTICLE 15. INDEPENDENT CONTRACTOR

  	
  26

  
	
   

  	
   

  
	
  ARTICLE 16. SEVERABILITY

  	
  27

  
	
   

  	
   

  
	
  ARTICLE 17. NON-ASSIGNABILITY

  	
  27

  
	
   

  	
   

  
	
  ARTICLE 18. NON-SOLICITATION

  	
  27

  
	
   

  	
   

  
	
  ARTICLE 19. ENTIRE AGREEMENT

  	
  27

  
	
   

  	
   

  
	
  ARTICLE 20. MODIFICATIONS IN WRITING

  	
  28

  
	
   

  	
   

  
	
  ARTICLE 21. GOVERNING LAW

  	
  28

  
	
   

  	
   

  
	
  ARTICLE 22. CAPTIONS

  	
  28

  



 


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.


 


ii

















 


	
  ARTICLE 23. CONSTRUCTION

  	
  28

  
	
   

  	
   

  
	
  ARTICLE 24. COUNTERPARTS

  	
  28

  
	
   

  	
   

  
	
  ARTICLE 25. BINDING EFFECT

  	
  28

  
	
   

  	
   

  
	
  ARTICLE 26. FORCE MAJEURE

  	
  28

  
	
   

  	
   

  
	
  ARTICLE 27. JHU LICENSE AGREEMENT

  	
  29

  



 


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.


 


iii

















 


AMENDED AND RESTATED LICENSE AGREEMENT


 


THIS AMENDED AND RESTATED LICENSE AGREEMENT effective as of the Closing
Date (defined below) (the “Effective Date”) is by and between Genzyme
Corporation, a Massachusetts corporation having its principal offices at 500
Kendall Street, Cambridge, MA 02142 (“Genzyme”), through Genzyme’s
Genetics Division (formerly through its Molecular Oncology Division), and EXACT
Sciences Corporation (formerly EXACT Laboratories, Inc.), a Delaware corporation
having its principal offices at 100 Campus Drive, Marlborough, MA 01752 (“EXACT”).


 


WITNESSETH:


 


WHEREAS, the parties have entered into a License Agreement effective as
of March 25, 1999 (the “License Agreement”) under which Genzyme
granted to EXACT a license to certain patent rights;


 


WHEREAS, the parties expect to enter into a Collaboration, License and
Purchase Agreement (the “CLP Agreement”) contemporaneously with entering
into this Agreement, and the parties acknowledge that the execution of the CLP
Agreement is a precondition for the parties to be bound to this Agreement;


 


WHEREAS, Genzyme desires to waive any and all breaches of the License
Agreement by EXACT that may have occurred (including any and all amounts due
Genzyme thereunder), and release EXACT from any liability arising therefrom;


 


WHEREAS, the parties desire to amend and restate the License Agreement,
effective as of the Effective Date;


 


NOW THEREFORE, in consideration of the mutual covenants herein
contained and intending to be legally bound hereby, the parties hereto agree to
amend and restate the License Agreement to read in its entirety as follows:


 


ARTICLE 1. 
DEFINITIONS


 


1.1.                             “Affiliate” shall
mean any corporation or other entity which controls, is controlled by, or is
under common control with EXACT. 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 fifty percent (50%) of the voting stock 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 or the power
to elect or appoint more than fifty percent (50%) of the members of the
governing body of the corporation or other entity.


 


1.2.                             “Agreement” shall
mean this Amended and Restated License Agreement, together with all Appendices,
Schedules and other attachments hereto.


 


1.3.                             “Change of Control of
EXACT” has meaning given to it in the CLP 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.


 


1

















 


1.4.                             “Closing Date” has
the meaning given to it in the CLP Agreement.


 


1.5.                             “Diagnostic Service(s)”
shall mean the performance of laboratory-based assays covered in whole or in
part by a Valid Claim of the Patent Rights.


 


1.6.                             “FDA Approval”
means either 510(k) clearance or approval of a Pre-Marketing Authorization
application (“PMA”) (or the equivalent of such submissions required at
such time) for a Kit from the FDA or any equivalent foreign regulatory agency
or body. “FDA Approved” has the correlative meaning.


 


1.7.                             “Field” shall mean (a) stool-based
detection of any disease or condition (including pre-cancers, staging and
monitoring of the foregoing, and therapeutic response) for research and
development, Clinical Laboratory Improvement Amendments (CLIA) testing services
(and their foreign equivalents), and FDA Approved Kits; and (b) a
screening assay (regardless of other uses to which such assay is put) for
colorectal cancer in any type of patient samples, excluding tests solely for
staging and/or monitoring of colorectal cancer which do not obsolete or
adversely impact such screening assay.


 


1.8.                             “First Commercial Sale”
shall mean, after the Effective Date, (a) the first performance for consideration
of a Diagnostic Service in the Field or (b) the first sale for
consideration of a Licensed Reagent or Kit for use in the Field, as applicable.
Any performance of a Diagnostic Service or transfer of Licensed Reagents or
Kits by EXACT solely for purposes of performing Research shall not be deemed to
constitute a First Commercial Sale.


 


1.9.                             “Gene Patent Rights”
shall mean the United States and foreign patents and patent applications
relating to the APC gene and/or the p53 gene and licensed (with the right to
grant sublicenses) to Genzyme pursuant to the JHU License Agreement together
with patents arising therefrom and any extensions, registrations,
confirmations, reissues, divisions, continuations or continuations-in-part,
re-examinations or renewals thereof, including without limitation the patents
and patent applications listed in Appendix A hereto (which may be updated from
time to time to include such additional patents and patent application that may
arise therefrom); provided, however, that Gene
Patent Rights expressly excludes any claims of such patents and patent
applications that fall outside of the Field, including, without limitation,
claims to antibodies, to the treatment, prevention or remedying of a gene
deficiency, to purified proteins, or to DNA sequences other than those
sequences that correspond to the p53 gene and the APC gene; provided further that DNA sequences which are (i) immediately
adjacent to the p53 or APC genes and (ii) necessary to the use of the p53
or APC genes, respectively, in the Field shall be considered within the Gene
Patent Rights.


 


1.10.                       “Instrument” shall mean
any instrument, apparatus, appliance, automated system or computer software
that is covered in whole or in part by a Valid Claim of the Patent Rights and
is useful or necessary for performing laboratory-based assays.


 


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

















 


1.11.                       “JHU License Agreement”
shall mean the License Agreement dated as of February 5, 1992 by and
between Genzyme (as successor to PharmaGenics, Inc.), The Johns Hopkins
University (“JHU”) and Hoffman-La Roche Inc. (“Roche”), as
amended from time to time.


 


1.12.                       “Kit” shall mean a
collection of one or more Reagents, including at least one Licensed Reagent,
packaged in the form of a kit (including an FDA Approved kit).


 


1.13.                       “Licensed Reagent” shall
mean any Reagent covered in whole or in part by a Valid Claim of the Patent
Rights.


 


1.14.                       “Methodology Patent Rights”
shall mean the United States and foreign patents and patent applications
relating to methods of detecting mammalian nucleic acids isolated from stool
specimens and reagents therefor and licensed (with the right to grant
sublicenses) to Genzyme pursuant to the JHU License Agreement together with
patents resulting therefrom and any extensions, registrations, confirmations,
reissues, divisions, continuations or continuations-in-part, re-examinations or
renewals thereof, including without limitation the patents and patent
application listed in Appendix B hereto (which may be updated from time to time
to include such additional patents and patent applications that may arise
therefrom).


 


1.15.                       (a)                                   “Net Sales”
shall mean the adjusted gross sales of Licensed Reagents and Kits by EXACT less [********] of adjusted gross sales in lieu of items
such as custom duties, inbound transportation, insurance costs, agent’s
commission, bad debts, etc. The adjusted gross sales shall mean the actual
gross sales price of a Licensed Reagent or Kit billed by EXACT (not including
miscellaneous items on the invoice such as taxes, etc.) less
chargebacks, cash discounts, credits or allowances (not including miscellaneous
items credited such as taxes, etc.) including those incurred or granted on
account of price adjustments, rejections, returns, rebates or recalls of
Licensed Reagents or Kits previously sold. “Net Sales” does not include “no
charge” samples to the extent customary in the trade.


 


(b)                                 In
the event that EXACT decides to sell a Kit which combines Licensed Reagents
with ingredients or components which are not Licensed Reagents (such other
ingredients or components being “Other Items”), then (i) EXACT
shall notify Genzyme in writing of its intent to offer such combination, (ii) Genzyme
and EXACT shall, within thirty (30) days after Genzyme’s receipt of such
notification, initiate good-faith negotiations on the value of the Licensed
Reagents which shall be used as the basis to calculate Net Sales pursuant to
this clause (b) and (iii) if the parties can not reach agreement
within thirty (30) days after the commencement of such negotiations, such
dispute shall be referred to arbitration pursuant to Article 11 hereof.
However, in no event shall the royalty rates on Net Sales be reduced by more
than [********]. The term “Other Items” does not include solvents, diluents,
carriers, excipients, enzymes used in amplification for diagnostic use, or the
like used in formulating a product.


 


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

















 


(c)                                  In
the event that a Licensed Reagent or Kit is sold for non-monetary consideration
in addition to or in lieu of money, the value of such consideration to the
extent that it can be reasonably determined by EXACT shall be added to Net
Sales in accordance with Sections 1.15 (a) and (b) hereof.


 


(d)                                 No
deductions shall be made for commissions paid to individuals whether they be
with independent sales agencies or regularly employed by EXACT and on its
payroll, or for cost of collections.


 


(e)                                  Net
Sales expressly excludes transfers or dispositions of Licensed Reagents or Kits
at cost or less than cost for the sole purpose of conducting Research.


 


1.16.                        (a)                                 “Net Service
Revenues” shall mean actual billings by EXACT for the performance of
Diagnostic Services less the following deductions to the extent that they are
applicable and are not already deducted in the actual billings: (i) discounts
allowed and taken, in amounts customary in the trade; (ii) sales and/or
use taxes and/or duties imposed upon and with specific reference to particular
sales.


 


(b)                                 If
a Diagnostic Service(s) is offered in combination with another diagnostic
or other service(s) (such as patient counseling) provided by EXACT (such
other services being referred to as “Other Services” and such Diagnostic
Service(s) and Other Services collectively being referred to as “Combination
Services”), Net Service Revenues for purposes of determining royalties on
the Diagnostic Service(s) shall be calculated as provided below:


 


(i)                                    If the Diagnostic
Service(s) and the Other Services are sold or provided separately, Net
Service Revenues shall be calculated by multiplying the Net Service Revenues of
the Combination Service (as determined in accordance with Section 1.16(a) above
but applied to the Combination Service), by the fraction A/(A+B), where “A” is
the invoice price of the Diagnostic Service(s) and “B” is the invoice price
of the Other Services in the Combination Service if sold or provided
separately.


 


(ii)                                 If the Diagnostic
Service(s) are sold or provided separately but the Other Services are not,
Net Service Revenues shall be calculated by multiplying the Net Service
Revenues of the Combination Service (as determined in accordance with Section 1.16(a) above
but applied to the Combination Service), by the fraction A/C, where “A” is the
invoice price of the Diagnostic Service(s) and “C” is the invoice price of
the Combination Service.


 


(iii)                              If the Diagnostic Service(s) and
the Other Services in the combination are not sold or provided separately, Net
Service Revenues for purpose of determining royalties on the Diagnostic Service(s) shall
be calculated by multiplying Net Service Revenues of the Combination Service
(as determined in accordance with Section 1.16(a) above but applied
to 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.


 


4

















 


Combination Service) by the fraction E/(E+D), where “E” is the value of
the Diagnostic Service(s) and “D” is the reasonably estimated value (using
accepted diagnostic industry standards) of the Other Services based at least in
part on the value of the other active component or components used in the
Combination Service; provided, that (A) EXACT shall notify Genzyme in
writing of its intent to offer such Combination Services, (B) Genzyme and
EXACT shall, within thirty (30) days after Genzyme’s receipt of such
notification, initiate good-faith negotiations on the value of the Diagnostic
Service(s) and Other Services which shall be used as the basis to
calculate Net Service Revenues pursuant to this clause (iii) and (C) if
the parties can not reach agreement within thirty (30) days after the
commencement of such negotiations, such dispute shall be referred to
arbitration pursuant to Article 11 hereof.


 


(c)                                  In
the event that a Diagnostic Service is provided for non-monetary consideration
in addition to or in lieu of money, the value of such non-monetary
consideration to the extent that it can be reasonably determined by EXACT shall
be added to Net Service Revenues in accordance with Sections 1.16(a) and (b) hereof.


 


(d)                                 Net
Service Revenues expressly excludes the use or performance of Diagnostic
Services at cost or less than cost for the sole purpose of conducting Research.


 


1.17.                       “Original Effective Date”
shall mean March 25, 1999.


 


1.18.                       “Patent Rights” shall
mean collectively the Gene Patent Rights and the Methodology Patent Rights.


 


1.19.                       “Reagents” shall mean
reagents useful in or necessary to the performance of laboratory-based assays,
whether used individually or sold or used as one or more component(s) of a
kit.


 


1.20.                       “Research” shall mean
pre-clinical, clinical and regulatory activities conducted by or on behalf of
EXACT to develop, evaluate, and obtain regulatory approvals of, products or
services utilizing the Patent Rights licensed to EXACT hereunder.


 


1.21.                       “Triggering Event” means [********].


 


1.22.                       “Valid Claim” shall mean
an issued claim of an unexpired patent, or a claim of a pending patent application,
which shall not have been withdrawn, canceled or disclaimed, or held invalid or
unenforceable by a court of competent jurisdiction in an unappealed or
unappealable decision. Notwithstanding the foregoing to the contrary, a claim
of a pending patent application, divisional application, or
continuation-in-part application, or the foreign equivalents thereof, shall
cease to be a Valid Claim if no patent has issued on such claim on or prior to
the fifth (5th) anniversary of the date of filing such patent application (or,
in the case of a continuation application or foreign equivalent thereof, the
date of filing of the earliest parent application), provided that such claim
shall once again 


 


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

















 


become a Valid Claim on the issue date of a patent that subsequently
issues and includes such claim.


 


ARTICLE 2. 
LICENSE GRANT AND WAIVER


 


2.1.                             Genzyme hereby grants to
EXACT, subject to all the terms and conditions of this Agreement, a worldwide,
nonexclusive right and license (without the right to grant sublicenses) under
the Patent Rights to: (a) use, offer to sell, sell and practice Diagnostic
Services in the Field; (b) make, have made, use, offer to sell, sell and
import Licensed Reagents in the Field; and (c) make, have made, use, offer
to sell, sell and import Kits in the Field. Notwithstanding the foregoing,
Genzyme hereby grants to EXACT the worldwide, non-exclusive right to convey to
the end-user (purchaser) of FDA Approved Kits manufactured by EXACT the right
to perform Diagnostic Services solely in conjunction with the use of FDA
Approved Kits manufactured by or on behalf of EXACT (without the right to grant
sublicenses).


 


2.2.                             The license granted
hereunder shall not extend to Instruments. In the event that Genzyme becomes aware
of any Instruments, Genzyme shall deliver written notice thereof to EXACT. In
the event that after the Original Effective Date EXACT decides in good faith to
develop Instruments for use in the Field and delivers written notice of such
decision to Genzyme, Genzyme and EXACT shall, within thirty (30) days after
Genzyme’s receipt of such notification from EXACT, enter into good faith
negotiations for a worldwide, non-exclusive license (without the right to grant
sublicenses) to be granted by Genzyme to EXACT under the Patent Rights to make,
use, offer to sell, sell and import Instruments in the Field. Any such license
shall include commercially reasonable terms and conditions. In the event that
Genzyme and EXACT are unable to reach agreement on the terms of any such
license within ninety (90) days after the date Genzyme and EXACT commence
negotiations for such license, then the dispute shall be immediately referred
to one (1) executive officer of each party, chosen at the sole discretion
of that party, who shall negotiate in good faith with each other to resolve the
dispute during the period ending thirty (30) days after the date of such
referral. If the designated officers of the parties are unable to resolve the
dispute within such thirty (30) day period, the dispute shall be referred to
arbitration pursuant to Article 11 hereof.


 


2.3.                             Each party (the “Granting
Party”) hereby grants to the other party (the “Recipient”) a
one-time waiver of any and all rights the Granting Party may have based on any
breaches of the License Agreement by the Recipient that occurred prior to the
Effective Date of this Agreement, including any and all amounts due to the
Granting Party under the License Agreement, and further including any and all
obligations of the Recipient that may be interpreted to have accrued under this
Agreement prior to the Effective Date, in each case whether or not known to the
Granting Party. In the case of a breach by the Recipient that first occurred
prior to the Effective Date, but such breach continues after the Effective
Date, the waiver and release granted in the prior sentence will only apply to
the extent that the breach occurred prior to the Effective Date, provided that
such waiver and release shall apply in connection with the disclosure by EXACT
of the terms of the License Agreement with the Securities and Exchange
Commission prior to the Effective Date as a result of the expiration of the
confidential treatment request filed with the Securities and Exchange
Commission for the License Agreement. The Granting Party will not assert any,
and hereby releases the Recipient and its Affiliates, and their officers,
directors, employees, agents, trustees, successors and assigns, from any and
all, claims, 


 


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

















 


rights, demands, actions, causes of action, suits, damages, losses,
liabilities, obligations, matters and issues arising from any such
breaches.  This Section 2.3 shall
apply to the Granting Party, the Granting Party’s Affiliates and their
successors and assigns.


 


ARTICLE 3. 
DILIGENCE


 


3.1.                             EXACT agrees to use
commercially reasonable efforts to make (i) Diagnostic Services,(ii) Licensed
Reagents and (iii) Kits available for the benefit of the general public
consistent with regulatory compliance and public safety.


 


3.2.                             EXACT’s material failure
to perform in accordance with any subsection of Section 3.1 above shall be
grounds for Genzyme to terminate the license under Section 2.1 above with
respect to Diagnostic Services, Licensed Reagents or Kits, as applicable,
pursuant to Section 7.8 hereof by delivering written notice of its
intention to terminate to EXACT. If EXACT disputes Genzyme’s determination, (i) EXACT
shall deliver written notice of such dispute within ten (10) business days
after its receipt of notice from Genzyme of its intent to terminate, (ii) the
matter shall be referred to arbitration pursuant to Article 11hereof and (iii) EXACT’s
license under Section 2.1 above to the Diagnostic Services, Licensed
Reagents or Kits, as applicable, and EXACT’s obligations with respect thereto
shall continue in full force and effect until the resolution of such
arbitration.


 


3.3.                             Within thirty (30) days
after the Original Effective Date and subsequently no later than May 1 and
November 1 of each year, commencing on November 1, 1999, EXACT shall
provide a written report to Genzyme on its research, development and
commercialization efforts with respect to (i) Diagnostic Services,
(ii)Licensed Reagents and (iii) Kits (each individually), which report
shall cite specific goals and objectives in researching, developing and
commercializing the licensed technology and methodology and progress in meeting
these goals and objectives. If Genzyme does not receive any such report(s) in
a timely manner, it shall notify EXACT of such delinquency in writing. EXACT
shall have thirty (30) days from its receipt of such notice to provide Genzyme
with any and all overdue report(s). Failure by EXACT to provide such overdue
report(s) within said thirty (30) day period may constitute grounds for
termination of this Agreement by Genzyme as provided for in Section 7.5
hereof; provided, however,
that the number of days elapsed since EXACT first received notice from Genzyme
of the delinquent reports shall be counted for purposes of determining the
sixty (60) day period described in Section 7.5 hereof.


 


ARTICLE 4. 
PAYMENTS


 


4.1.                             In partial consideration
for the license granted hereunder, and upon the Original Effective Date, EXACT
agrees to pay Genzyme [********], which amount shall not be creditable against
any other amounts payable by EXACT to Genzyme hereunder. Such [********]
payment has been made and no further upfront payment is due upon the Effective
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.


 


7
















 


4.2.                              EXACT
shall pay to Genzyme during the term of this Agreement a royalty calculated as
follows:


 


(a)                                  before a total of
[********] tests on individual patient samples in the aggregate have been sold
by EXACT, whether sold by EXACT as Diagnostic Services or sold by or on behalf
of EXACT as part of Licensed Reagents or Kits manufactured by or on behalf of
EXACT,


 


(i)                                     if
the average gross sale price of such Diagnostic Services, Licensed Reagents or
Kits is equal to or greater than [********], then the royalty shall be (i) the
greater of [********] of Net Service Revenue worldwide or [********] per
Diagnostic Service sold by EXACT, plus (ii) the greater of [********] of
Net Sales worldwide or [********] per test included in the Licensed Reagent or
Kit sold by or on behalf of EXACT; and


 


(ii)                                  if
the average gross sale price of such Diagnostic Services, Licensed Reagents or
Kits is less than [********], then the royalty shall be (i) [********] per
Diagnostic Service sold by EXACT, plus (ii) [********] per test included in the
Licensed Reagent or Kit sold by or on behalf of EXACT.


 


(b)                                 after [********] tests
on individual patient samples in the aggregate have been sold by EXACT, whether
sold by EXACT as Diagnostic Services or sold by or on behalf of EXACT as part of
Licensed Reagents or Kits manufactured by or on behalf of EXACT,


 


(i)                                     if
the average gross sale price of such Diagnostic Services, Licensed Reagents or
Kits is equal to or greater than [********], then the royalty shall be (i) the
greater of [********] of Net Service Revenue worldwide or [********] per
Diagnostic Service sold by EXACT, plus (ii) the greater of [********] of
Net Sales worldwide or [********] per test included in the Licensed Reagent or
Kit sold by or on behalf of EXACT; and


 


(ii)                                  if
the average gross sale price of such Diagnostic Services, Licensed Reagents or
Kits is less than [********], then the royalty shall be (i) [********] per
Diagnostic Service sold by EXACT, plus (ii) [********] per test included in the
Licensed Reagent or Kit sold by or on behalf of EXACT.


 


(c)                                  for revenue, other
than Net Sales and Net Services Revenue, generated by EXACT by exploiting the
rights granted by Genzyme under this Agreement, [********] of such revenue.


 


For clarity, (i) the foregoing royalties
and the milestones set forth in Section 4.5 that are applicable to
Diagnostic Services shall only apply to Diagnostic Services performed by EXACT
and not by end-users (purchasers) and (ii) for purposes of this Section 4.2,
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.


 


8

















 


average gross sales price of Licensed
Reagents and Kits shall be calculated over the applicable calendar quarter for
which royalties are payable.


 


4.3.                              (a)                                  With
respect to the licenses granted for Diagnostic Services, EXACT shall pay
Genzyme a minimum royalty of, (i) before a Triggering Event has occurred,
[********] per year, (ii) if a Triggering Event has occurred at any time
prior to the [********] anniversary of the Effective Date of this Agreement,
[********] per year, (iii) if a Triggering Event has occurred at any time
on or after the [********] anniversary of the Effective Date and prior to the
[********] anniversary of the Effective Date, [********] per year, and (iv) if
a Triggering Event has occurred at any time on or after the [********] anniversary
of the Effective Date, [********] per year. 
In each case, the minimum royalty will be payable on January 1 of
each year with respect to the licenses granted for Diagnostic Services; provided,
however, that the minimum royalty for a given year shall be creditable
against any royalties subsequently due during said year under Section 4.2.  For clarity, if a Triggering Event occurs in
such a year, the applicable minimum royalty described in clauses (ii) through
(iv) in this Section 4.3(a) shall not apply until January 1
of the year following the occurrence of such Triggering Event, unless such
Triggering Event occurs on January 1 of a year.


 


(b)                                 With respect to the
licenses granted for Licensed Reagents and Kits, EXACT shall pay Genzyme a
minimum royalty of, (i) before a Triggering Event has occurred, [********]
per year, (ii) if a Triggering Event has occurred at any time prior to the
[********] anniversary of the Effective Date of this Agreement, [********] per
year, (iii) if a Triggering Event has occurred at any time on or after the
[********] anniversary of the Effective Date and prior to the [********]
anniversary of the Effective Date, [********] per year, and (iv) if a
Triggering Event has occurred at any time on or after the [********]
anniversary of the Effective Date, [********] per year.  In each case, the minimum royalty will be
payable on January 1 of each year with respect to the licenses granted for
Licensed Reagents and Kits; provided, however, that the minimum
royalty for a given year shall be creditable against any royalties subsequently
due during said year under Section 4.2. 
For clarity, if a Triggering Event occurs in such a year, the applicable
minimum royalty described in clauses (ii) through (iv) in this Section 4.3(b) shall
not apply until January 1 of the year following the occurrence of such
Triggering Event, unless such Triggering Event occurs on January 1 of a
year.


 


(c)                                  Waiver or deferral of
any minimum royalty payment by Genzyme shall not be construed as waiver or
deferral of any such subsequent payment.


 


4.4.                              (a)                                  In
the event that the First Commercial Sale of a Diagnostic Service by EXACT has
not occurred within [********] after the Effective Date, EXACT shall pay
Genzyme an annual maintenance fee of [********] payable on each anniversary of
the Effective Date commencing with the [********] anniversary of the Effective
Date; provided, however,
that if EXACT has submitted a bona fide
application to the U.S. Food and Drug Administration or the equivalent
authority at that time (“FDA”) to obtain final marketing approval for a
Diagnostic Service within said [********] period and EXACT’s failure to make
such First Commercial Sale is due to delays in obtaining such approval that are



 


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

















 


caused by the FDA and are not related to a
substantial deficit in said application, then Genzyme may elect, in its sole
discretion, acting reasonably, to extend said [********] period and shall
notify EXACT in writing of any such determination and election and of the amount
of time by which such period has been extended; provided
further that if the parties disagree as to whether said application
contained a substantial deficit and the time for resolution of such deficit,
the dispute shall be referred to arbitration pursuant to Article 11 hereof
and, until final resolution of the dispute, EXACT shall deposit any amounts
otherwise due and payable to Genzyme under this Section4.4(a) into an
escrow account established by EXACT exclusively for such purpose in a
recognized commercial banking institution reasonably selected by EXACT and
promptly identified by written notice from EXACT to Genzyme. If the arbitrator
resolves the dispute in favor of Genzyme, then the amounts held in escrow plus all interest accrued thereon shall be promptly paid to
Genzyme in same day funds. Amount payable under this Section 4.4(a) shall
not be creditable against any royalties or other payments due during said year
under this Article 4. Waiver or deferral of any maintenance fee by Genzyme
shall not be construed as waiver or deferral of any such subsequent payment.


 


(b)                                 In the event that the
First Commercial Sale of a Kit by EXACT has not occurred within [********]
after the Effective Date and the license granted pursuant to Section 2.1 (c) hereof
has not been terminated by Genzyme pursuant to Section 7.7 hereof, EXACT
shall pay Genzyme an annual maintenance fee of [********] payable on each
anniversary of the Effective Date commencing with the [********] anniversary of
the Effective Date; provided, however, that if EXACT has submitted a bona fide
application to the FDA to obtain final marketing approval for a Kit prior to
[********] and EXACT’s failure to make such First Commercial Sale is due to
delays in obtaining such approval that are caused by the FDA and are not
related to a substantial deficit in said application, then Genzyme may elect,
in its sole discretion, acting reasonably, to extend said [********] period and
shall notify EXACT in writing of any such determination and election and of the
amount of time by which such period has been extended; provided
further that if the parties disagree as to whether said application
contained a substantial deficit and the time for resolution of such deficit,
the dispute shall be referred to arbitration pursuant to Article 11 hereof
and, until final resolution of the dispute, EXACT shall deposit any amounts
otherwise due and payable to Genzyme under this Section 4.4(b) into
an escrow account established by EXACT exclusively for such purpose in a
recognized commercial banking institution reasonably selected by EXACT and
promptly identified by written notice from EXACT to Genzyme. If the arbitrator
resolves the dispute in favor of Genzyme, then the amounts held in escrow plus all interest accrued thereon shall be promptly paid to
Genzyme in same day funds. Amount payable under this Section 4.4(b) shall
not be creditable against any royalties or other payments due during said year
under this Article 4. Waiver or deferral of any maintenance fee by Genzyme
shall not be construed as waiver or deferral of any such subsequent payment.


 


4.5.                              (a)                                  EXACT
shall pay Genzyme a one-time milestone payment in the amount of [********]
within [********] after first receiving FDA Approval. Such amount shall not be
creditable against any royalties or other payments due under this Article 4.


 


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

















 


(b)                                 EXACT shall pay
Genzyme a one-time milestone payment in the amount of [********] within [********]
after EXACT has sold [********] tests on individual patient samples in the
aggregate, whether sold as Diagnostic Services or as part of Licensed Reagents
or Kits.


 


(c)                                  EXACT shall pay
Genzyme a one-time milestone payment in the amount of [********] within [********]
after EXACT has sold [********] tests on individual patient samples in the
aggregate, whether sold as Diagnostic Services or as part of Licensed Reagents
or Kits.


 


(d)                                 For clarification,
once EXACT has made any particular milestone payment under this Section 4.5,
EXACT will not be obligated to make any payment under this Section 4.5
with respect to the reoccurrence of the same milestone.


 


4.6.                              Payment
of royalties specified in Section 4.2 shall be made by EXACT to Genzyme
within forty-five (45) days after March 31, June 30, September 30
and December 31 each year during the term of this Agreement covering Net
Sales and Net Service Revenues during the preceding calendar quarter. The last
such payment shall be made within forty-five (45) days after the expiration or
earlier termination of this Agreement.


 


4.7.                              No
multiple royalties shall be payable on any Diagnostic Service, Licensed Reagent
or Kit because such Diagnostic Service, Licensed Reagent or Kit or its
practice, manufacture, use, importation or sale is or shall be covered by more
than one of the Patent Rights.


 


4.8.                              All
payments to be made under this Article 4 shall be paid in United States
dollars, in Boston, Massachusetts or at such other place and in such other way
as Genzyme may reasonably designate in writing, without deduction of exchange,
collection or other charges. Conversion of foreign currency into United States
dollars shall be calculated using the applicable exchange rate as published in
The Wall Street Journal on the date that the payment is first due and payable.
If by law, regulation or fiscal policy of a particular country, conversion into
United States dollars or transfers of funds of a convertible currency to the
Untied States is restricted or forbidden, EXACT shall give Genzyme prompt
written notice of such restriction or prohibition, which notice shall satisfy
the forty-five (45) day payment deadline set forth in Section 4.6. EXACT
shall pay any amounts due to Genzyme through whatever lawful methods Genzyme
reasonably designates in writing; provided, however, that if Genzyme fails to designate such payment
method within thirty (30) days after Genzyme is notified of the restriction,
EXACT may deposit such payment in local currency to the credit of Genzyme in a
recognized commercial banking institution reasonably selected by EXACT and
promptly identified by written notice from EXACT to Genzyme, and such deposit
shall fulfill all obligations of EXACT to Genzyme with respect to such payment.


 


4.9.                              In
the event that any payment due hereunder is not made when due, the payment
shall accrue interest beginning on the first day following the due date as
herein specified, calculated at the annual rate of the sum of [********], the
interest being compounded on 


 


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

















 


the last day of each calendar quarter;
provided, that in no event shall said annual rate exceed the maximum legal
interest rate in Massachusetts. The payment of such interest shall not
foreclose Genzyme from exercising any other rights it may have as a consequence
of the lateness of any payment.


 


4.10.                        Royalty
payments and other payments due to Genzyme under this Agreement shall not be
reduced by reason of any withholding or similar taxes applicable to such
payments to Genzyme.


 


4.11.                        [********]


 


ARTICLE
5.  REPORTS AND RECORDS


 


5.1.                              EXACT
shall maintain true, accurate and complete books of account, records and files
containing an accurate record of all data reasonably necessary for the full
computation and verification of sales and the determination of the amounts
payable under Article 4 hereof for a period of at least four (4) years
following the period of each report required by Section 5.2 below. Said
books and records shall be kept at EXACT’s principal place of business and
shall be in accordance with generally accepted accounting principles, consistently
applied. Said books and records, to the extent not previously audited, shall be
available for inspection by an independent certified public accountant selected
by Genzyme (or its licensor of the Patent Rights) and reasonably acceptable to
EXACT, upon ten (10) business days advance written notice and during
regular business hours, for three (3) years following the end of the
calendar year to which they pertain in order to enable Genzyme (or its licensor
of the Patent Rights) to ascertain the correctness of any report and/or payment
made under this Agreement. Such inspections may be conducted no more than once
in any twelve (12) month period and, except as provided below, shall be
conducted at the expense of Genzyme (or its licensor, as the case may be). If
such examination reveals that royalties have been misstated, any adjustment
shall be promptly refunded or paid, as appropriate. Genzyme (or its licensor,
as the case may be) shall pay the fees and expenses of the accountant engaged
to perform the audit, unless such audit reveals an underpayment of five percent
(5%) or more for the period examined, in which case EXACT shall pay all
reasonable costs and expenses incurred by Genzyme (or its 


 


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

















 


licensor, as the case may be) in the course
of making such determination, including without limitation the fees and
expenses of the accountant.


 


5.2.                              Within
forty-five (45) days after March 31, June 30, September 30 and December 31,
of each year in which this Agreement is in effect, EXACT shall deliver to
Genzyme full, true and accurate reports of its activities relating to this
Agreement during the preceding three month period. These reports shall include
at least the following:


 


(a)                                  the total actual
billings for Diagnostic Services on a country-by-country basis during the
applicable period;


 


(b)                                 the total gross sales
of Licensed Reagents and Kits, each individually, on a country-by-country basis
during the applicable period;


 


(c)                                  the calculation of
Net Service Revenues and Net Sales on a country-by-country basis for the
applicable period, including a detailed listing of the applicable deductions
permitted under Sections 1.15 and 1.16 hereof on an item-by-item basis and a
detailed explanation of the calculation of Net Service Revenues and Net Sales
of any Combination Services or combination products; and


 


(d)                                 the calculation of
total royalties due in U.S. dollars, together with the exchange rates used for
conversion, to the extent applicable.


 


5.3.                              With
each such report, EXACT shall pay to Genzyme the royalties due and payable as
provided for in Section 4.2. To the extent that royalties for the
applicable period are creditable against minimum royalties paid pursuant to Section 4.3
hereof, EXACT shall so report. If no royalties are due, EXACT shall so report.


 


ARTICLE
6.  PATENT PROSECUTION; INFRINGEMENT


 


6.1.                              The
prosecution, filing and maintenance of all patents and the expense thereof
shall be the responsibility of Genzyme (and/or its licensor of the Patent
Rights).


 


6.2.                              (a)                                  EXACT
agrees to provide Genzyme with prompt written notice after becoming aware of
any infringement of any of the Patent Rights.


 


(b)                                 Genzyme (or its
licensor, as the case may be) shall have the right, under its control and at
its expense, to prosecute any third party infringement of the Patent Rights or
to defend the Patent Rights in any declaratory judgment action brought by a
third party which alleges the invalidity, unenforceability or non-infringement
of any Patent Right. EXACT agrees to cooperate fully in any action under this Section 6.2,
provided that Genzyme (or its licensor, as the case may be) reimburses EXACT
for its reasonable costs and expenses incurred in connection with providing
such assistance.


 


(c)                                  In the event that


 


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

















 


(i)                                    EXACT
notifies Genzyme that a third party is conducting activities in the Field that
infringe the Patent Rights in any country,


 


(ii)                                 said
third party continues to infringe for [********] after receipt by Genzyme of
such notice and does not obtain a license from Genzyme under the applicable
Patent Rights within such period, and


 


(iii)                              EXACT
can demonstrate to Genzyme’s reasonable satisfaction through written
documentation that (A) EXACT has Net Sales or Net Service Revenues in one or
more countries in which there is any Valid Claim within the Patent Rights, and (B) the
infringing activities of said third party have resulted in annualized income to
said third party equal to or greater than (x) [********] worldwide in
countries in which there is any Valid Claim within the Patent Rights
(determined based on Net Sales or Net Service Revenues of the [********]) or (y) [********]
of EXACT’s annualized Net Sales or Net Service Revenues (as applicable)
worldwide in countries in which there is any Valid Claim within the Patent
Rights (determined based on Net Sales or Net Service Revenues of the
[********]), whichever is greater,


 


then, after making such a demonstration,
EXACT may withhold up to [********] of the royalty payments that would
otherwise be payable to Genzyme on Net Services Revenues from Diagnostic
Services covered in whole or in part by the infringed Patent Rights or on Net
Sales of Licensed Reagents or Kits covered in whole or in part by the infringed
Patent Rights, as applicable, in such countries until such time as the
infringement is abated; provided, however, that in the event that Genzyme (or its licensor, as
the case may be) either (A) fails to use good faith efforts to undertake
the prosecution of such third party infringement or otherwise Resolve such
infringement within two hundred and forty (240) days after receipt by Genzyme
of the notice delivered by EXACT pursuant to clause (c)(i) above or (B) delivers
written notice to EXACT that Genzyme (or its licensor, as the case may be) does
not intend to undertake the prosecution of such third party infringement, then
EXACT may withhold [********] of the aforementioned royalty payments; provided further that, if EXACT withholds such royalty
payments and Genzyme (or its licensor, as the case may be) either successfully
Resolves such infringement or undertakes the prosecution of such third party
infringement and obtains a favorable judgment, settlement, consent judgment or
other final disposition of the suit, EXACT shall resume full payment of the aforementioned
royalties due under this Agreement on Net Service Revenues and Net Sales in
such countries upon receipt of either written notice of the successful
abatement of such infringement by prosecution or Resolution signed by an
officer of Genzyme or a copy of an official, written evidence of such favorable
judgment, settlement, consent judgment or other final disposition; provided further that in the event that Genzyme (or its
licensor, as the case may be) undertakes the prosecution of such infringement and
obtains a favorable settlement, an order to dismiss shall constitute adequate
official written evidence for purposes of this sentence. For purposes of this
clause (c), “Resolve(s)” or “Resolution” means the cessation of
such third party infringement other than as a result of prosecution, including 


 


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

















 


without limitation the grant of a
nonexclusive license under the Patent Rights or the discontinuance by such
third party of the infringing activities.


 


(d)                                 If Genzyme notifies
EXACT in writing within ten (10) days of receiving written documentation
pursuant to Section 6.2(c)(iii) above that Genzyme is not reasonably
satisfied that EXACT has demonstrated conditions sufficient to justify the
withholding of royalty payments under Section 6.2(c) above, then,
until final resolution of the dispute, EXACT shall deposit all withheld royalty
payments otherwise due and payable to Genzyme into an escrow account
established by EXACT exclusively for such purpose in a recognized commercial
banking institution reasonably selected by EXACT and promptly identified by
written notice from EXACT to Genzyme. If the parties are unable to resolve the
dispute within thirty (30) days after EXACT’s receipt of Genzyme’s notice, then
the dispute shall immediately be referred to one (1) executive officer of
each party, chosen in the sole discretion of that party, who shall negotiate
with each other in good faith to resolve the dispute during the period ending
thirty (30) days after the date of such referral. If the designated officers of
the parties are unable to resolve the dispute within such thirty (30) day
period, the dispute shall be referred to arbitration pursuant to Article 11
hereof. If such officers or the arbitrator, as applicable, resolves the dispute
in favor of Genzyme, then the amounts held in escrow plus all interest accrued
thereon shall be promptly paid to Genzyme in same day funds and EXACT shall
resume full payment of royalties under this Agreement.


 


(e)                                  In the event that
EXACT withholds royalty payments pursuant to Section 6.2(c), EXACT shall
include the amount of such withheld royalties and the basis for the calculation
thereof on a country-by-country basis in the reports deliverable by EXACT to
Genzyme pursuant to Section 5.2 hereof as distinct line items.


 


(f)                                    EXACT hereby
acknowledges and agrees that Roche has rights under the Patent Rights under an
agreement with JHU and, therefore, activities by Roche in accordance with such
agreement with JHU will not be subject to this Section 6.2.


 


ARTICLE
7.  TERM AND TERMINATION


 


7.1.                              Unless
earlier terminated as hereinafter provided, this Agreement shall remain in full
force and effect until the expiration of the last to expire Patent Rights.
Royalties on Net Service Revenues from Diagnostic Services and on Net Sales of
Licensed Reagents and Kits covered by the Gene Patent Rights shall cease upon
the expiration of the last to expire Gene Patent Right. Royalties on Net
Service Revenues of Diagnostic Services and on Net Sales of Licensed Reagents and
Kits covered by the Methodology Patent Rights shall cease upon the expiration
of the last to expire Methodology Patent Right.


 


7.2.                              If (a) Genzyme,
acting reasonably, determines that EXACT has ceased to carry on its business
with respect to the performance of Diagnostic Services in the Field and/or the
provision of Licensed Reagents and/or Kits in the Field in any country in North
America or Europe for a period of more than [********] with no plan to resume
such business within the following [********], then (b) Genzyme shall have
the right to terminate this 


 


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

















 


Agreement and all rights, privileges and
license hereunder granted with respect to such Diagnostic Services and/or
Licensed Reagents and/or Kits, as applicable, upon [********] prior written
notice to EXACT; provided, however,
that if EXACT is temporarily unable to carry on such business due to a
corporate reorganization or restructuring of EXACT, then the [********] time
period set forth in clause (a) of this Section 7.2 shall be
reasonably extended to accommodate such corporate circumstance by a period to
be mutually agreed upon by the parties, which extension period shall not exceed
[********]. Such termination shall become effective immediately upon the
conclusion of such notice period unless EXACT shall have resumed such business
in good faith prior to the expiration of such notice period.


 


7.3.                              Should
EXACT fail to pay Genzyme any amounts as are due and payable hereunder, Genzyme
shall have the right to terminate this Agreement upon forty-five (45) days
prior written notice, unless EXACT shall pay Genzyme within said forty-five
(45) day period such delinquent amounts and all interest due and payable
thereon. If EXACT shall not have paid all such delinquent amounts and interest
due and payable thereon within said period, Genzyme, at its sole option, may
immediately terminate this Agreement and all rights, privileges and license
hereunder granted.


 


7.4.                              EXACT
shall have the right to terminate this Agreement and all rights, privileges and
license hereunder granted at any time upon one hundred eighty (180) days prior
written notice to Genzyme.


 


7.5.                              Upon
any material breach or default of this Agreement by EXACT, other than those
delineated in Sections 7.2 and 7.3, which shall always take precedence in that
order over any material breach or default referred to in this Section 7.5,
Genzyme shall have the right to terminate this Agreement and the rights,
privileges and license hereunder granted upon sixty (60) days prior written
notice to EXACT. Such termination shall become effective immediately at the
conclusion of such notice period unless EXACT shall have cured any such breach
or default prior to the expiration of said sixty (60) day period.


 


7.6.                              (a)                                  If
no royalties have been paid by EXACT with respect to any Diagnostic Service
within [********] after the First Commercial Sale by EXACT of a Diagnostic
Service, the rights, privileges and license granted under this Agreement to
EXACT under Section2.1 (a) hereof shall automatically terminate.


 


(b)                                 If no royalties have
been paid by EXACT with respect to any Licensed Reagent within [********] after
the First Commercial Sale of a Licensed Reagent, the rights, privileges and
license granted under this Agreement to EXACT under Section 2.1 (b) hereof
shall automatically terminate.


 


7.7.                              (a)                                  If
EXACT fails to make a 510(k) or PMA submission for a Kit to the FDA (or
the equivalent of such submissions as may be required by the FDA at such time)
on or before [********], Genzyme may, in its sole discretion, elect to
terminate the rights, privileges and license granted under Section 2.1 (c) hereof
in any or each country in which 


 


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

















 


Genzyme has Patent Rights unless such license
grant is sooner terminated according to the terms of this Agreement.


 


(b)                                 If EXACT fails to
achieve annual Net Sales of Licensed Reagents and Kits for use in the Field of
[********] or more within [********] after the First Commercial Sale of a Kit,
Genzyme may, in its sole discretion, elect to terminate the rights, privileges
and license granted under Section 2.1 (c) hereof in any and each
country in which Genzyme has Patent Rights unless such license grant is sooner
terminated according to the terms of this Agreement.


 


7.8.                              If EXACT
materially fails to perform in accordance with clauses (i), (ii) or (iii) of
Section 3.1 hereof, Genzyme may elect to terminate the rights, privileges
and license granted under Section 2.1 with respect to the subject matter
of the clause or clauses of Section 3.1 under which EXACT has materially
failed to perform, as set forth in Section 3.2, hereof upon thirty (30)
days prior written notice to EXACT. Notwithstanding the foregoing, any
termination of the license granted under any one clause of Section 2.1
pursuant to this Section 7.8 will be effective only with respect to the
subject matter of the clause of Section 3.1 under which EXACT has
materially failed to perform, and the remaining clauses of Section 3.1 and
the remaining rights granted under 2.1 shall be unaffected by such termination.


 


7.9.                              Upon
any termination of this Agreement in its entirety or any of the rights,
privileges and licenses granted under Section 2.1 hereof, EXACT shall be
entitled to finish any work-in-progress and to sell any completed inventory of
Licensed Reagents or Kits, as applicable, which remain on hand as of the date
of the termination provided that EXACT pays Genzyme the royalties applicable to
said subsequent sales in accordance with the terms and conditions set forth in
this Agreement.


 


7.10.                        (a)                                  In
the event that Genzyme terminates this Agreement and the rights, privileges and
licenses hereunder granted pursuant to Section 7.2 above, then Genzyme
shall refund to EXACT the pro rata
share of the amount equal to the sum of (i) any payment made by EXACT pursuant
to Section 4.3 hereof on January 1 of the calendar year in which the
effective date of such termination falls plus (ii) any
payment made by EXACT pursuant to Section 4.4 hereof on the anniversary of
the Original Effective Date immediately preceding the effective date of such
termination plus (iii) one-half of any payment
made by EXACT pursuant to Section 4.5 hereof if the license granted under Section 2.1
(c) is being terminated and if such payment was made by EXACT within the
six (6) month period immediately preceding the effective date of such
termination less (iv) the aggregate amount of any payments made by Genzyme
to JHU in that Year under the JHU License Agreement based on the payments
described in clauses (i), (ii) and (iii) above.


 


(b)                                 In the event that
Genzyme terminates the license granted under Section 2.1 (a) hereof
with respect to Diagnostic Services pursuant to Section 7.6 or 7.8 hereof,
then Genzyme shall refund to EXACT the pro rata
share of the amount equal to the sum of (i) any payment made by EXACT
pursuant to Section 4.3(a) hereof on January 1 of the calendar
year in which the effective date of such termination falls plus
(ii) any payment 


 


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

















 


made by EXACT pursuant to Section 4.4(a) hereof
on the anniversary of the Original Effective Date immediately preceding the
effective date of such termination less (iii) the amount of any payment
made by Genzyme to JHU in that Year based on the payments described in clauses (i) and
(ii) above.


 


(c)                                  In the event that
Genzyme terminates the rights, privileges and license granted under Section 2.1
(b) or (c) hereof with respect to Licensed Reagents and Kits pursuant
to Sections 7.7 or 7.8 hereof, then Genzyme shall refund to EXACT the pro rata share of the amount equal to the sum of (i) any
payment by EXACT to Genzyme pursuant to Section 4.3(b) hereof on January 1
in which the calendar year of the effective date of such termination falls plus (ii) any payment made by EXACT pursuant to Section 4.4(b) hereof
on the anniversary of the Original Effective Date immediately preceding the
effective date of such termination plus (iii) one-half
of any payment made by EXACT pursuant Section 4.5 hereof to if the license
granted under Section 2.1 (c) is being terminated and if such payment
was made to Genzyme within six (6) months immediately preceding the
effective date of such termination less (iv) the aggregate amount of any
payments made by Genzyme to JHU in that Year based on the payments described in
clauses (i), (ii) and (iii) above.


 


(d)                                 The pro rata share of any amounts to be refunded by Genzyme
pursuant to this Section 7.10 shall be determined based on either (i) the
portion of the twelve (12) month period after said anniversary of the Original
Effective Date or (ii) the portion of said calendar year, as applicable,
during which this Agreement shall not be in effect. In no event shall any
amounts be refundable by Genzyme to the extent they have been credited by
Genzyme against royalties payable by EXACT in accordance with Sections 4.3
and/or 4.4 hereof. Interest paid to Genzyme pursuant to Section 4.9 hereof
or on any amounts held in escrow during the pendency of a dispute shall not be
included in the calculation of any amounts refundable by Genzyme.


 


(e)                                  Any and all amounts
refundable by Genzyme to EXACT pursuant to this Section 7.10 shall be paid
to EXACT within thirty (30) days after the applicable effective date of the
termination.


 


7.11.                        Upon the
expiration or the earlier termination of this Agreement for any reason, nothing
herein shall be construed to release either party from any obligation that
matured prior to the effective date of such expiration or the termination. The
provisions of Articles 5, 8, 10, 11, 13, 18 and 21, Section 4.6, 7.9, 7.10
and this Section 7.11 shall survive the expiration or earlier termination
of this Agreement.


 


ARTICLE
8.  INDEMNIFICATION AND INSURANCE


 


8.1.                              (a)                                  Subject
to the provisions of Section 8.3 hereof, EXACT shall indemnify, defend and
hold harmless Genzyme, JHU, The John Hopkins Health System (“JHHS”) and
their respective present and former officers, directors, trustees, employees,
consultants, agents, students, faculty, treating and consulting physicians,
inventors of the Patent Rights, subsidiaries, successors, heirs and assigns
(collectively, the “Genzyme Indemnitees”) 


 


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

















 


against any liability, damage, loss or
expense (including reasonable attorneys’ fees and expenses of litigation)
incurred by or imposed upon the Genzyme Indemnitees, or any one of them, in
connection with any claims, suits, actions, demands or judgments arising out of
(i) the design, sale, use, manufacture or promotion by EXACT and its
officers, directors, employees, representatives and agents, of any process,
service or product relating to, or developed, manufactured, used or
commercialized pursuant to, this Agreement and (ii) the practice and use
of the Patent Rights by EXACT and its officers, directors, employees,
representatives and agents.


 


(b)                                 EXACT’s
indemnification under this Section 8.1 shall not apply to any liability,
damage, loss or expense to the extent that it is directly attributable to the
negligence, reckless misconduct or intentional misconduct of the Genzyme
Indemnitees.


 


(c)                                  EXACT agrees, at its
own expense, to provide attorneys to defend against any actions brought or
filed against any Genzyme Indemnitee with respect to the subject of indemnity
contained herein, whether or not such actions are rightfully brought, such
attorneys to be reasonably acceptable to Genzyme and not to be subject to any
conflict of interest in representing any of the Genzyme Indemnitees nor to have
been deemed within the preceding ten (10) years by any Genzyme Indemnitee
to have provided unsatisfactory legal representation of such Genzyme
Indemnitee.


 


8.2.                              (a)                                  Subject
to the provisions of Section 8.3 hereof Genzyme shall indemnify, defend
and hold harmless EXACT and its present and former officers, directors,
employees, agents, consultants, successors, heirs and assigns (collectively,
the “EXACT Indemnitees”) against any liability, damage, loss or expense
(including reasonable attorney’s fees and expenses of litigation) incurred by
or imposed upon the EXACT Indemnitees, or anyone of them, in connection with
any claims, suits, actions, demands or judgments arising out of (i) the
design, sale, use, manufacture or promotion by Genzyme and its officers,
directors, employees, representatives and agents, of any process, service or
product utilizing the Patent Rights in the Field and (ii) the practice and
use of the Patent Rights in the Field by Genzyme and its officers, directors,
employees, representatives and agents.


 


(b)                                 Genzyme’s
indemnification under this Section 8.2 shall not apply to any liability,
damage, loss or expense to the extent it is directly attributable to the
negligence, reckless misconduct or intentional misconduct of the EXACT
Indemnitees.


 


(c)                                  Genzyme agrees, at
its own expenses to provide attorneys to defend against any actions brought or
filed against any EXACT Indemnitee with respect to the subject of indemnity
contained herein, whether or not such actions are rightfully brought, such
attorneys to be reasonably acceptable to EXACT and not to be subject to any
conflict of interest in representing any of the EXACT Indemnitees not to have
been deemed within the preceding ten (10) years by any EXACT Indemnitee to
have provided unsatisfactory legal representation of such EXACT Indemnitee.


 


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
















 


8.3.          In the event any such
action is commenced or claim made or threatened against an indemnified party
covered by Section 8.1 or 8.2 hereof, the indemnified party shall promptly
notify the indemnifying party in writing of such event. The failure of indemnified
party to deliver notice to the indemnifying party within a reasonable time
after the commencement of any such action, if materially prejudicial to the
ability of the indemnifying party to defend such action, shall relieve the
indemnifying party of any liability to the indemnified party under this Article 8
solely with respect to such action, but the failure to deliver notice to the
indemnifying party will not relieve it of any liability with respect to such
action that it may have to the indemnified party otherwise than under this Article 8.
The indemnifying party shall assume, with the reasonable cooperation of the
indemnified party, the investigation and defense of, and may settle that part
of, any such claim or action commenced or made against the indemnified party
which relates to the indemnifying party’s indemnification and the indemnifying
party may take such other steps as may be necessary to protect itself. The
indemnifying party shall not be liable to indemnified party on account of any
settlement of any such claim or litigation affected without the indemnifying
party’s express written consent, which consent shall not be unreasonably
withheld or delayed. The right of the indemnifying party to assume the defense
of any action shall be limited to that part of the action commenced against an
indemnified party which relates to the indemnifying party’s obligation of
indemnification and holding harmless.


 


8.4.          (a)           Beginning at such time as any Diagnostic
Service, Licensed Reagent or Kit relating to, or developed pursuant to, this
Agreement is being made available (other than for the purpose of obtaining
regulatory approvals) by EXACT, EXACT shall, at its sole cost and expense,
procure and maintain commercial general liability insurance, applicable worldwide,
in amounts not less than [********] per incident and [********] annual
aggregate and naming Indemnitees as additional insureds. Such commercial
general liability insurance shall provide (i) product liability coverage
and (ii) contractual liability coverage for EXACT’s indemnification under Section 8.1
of this Agreement. If EXACT elects to self-insure all or part of the limits
described above (including deductibles or retentions that are in excess of
[********] annual aggregate) such self-insurance program must be acceptable to
Genzyme. The minimum amounts of insurance coverage required under this Section 8.4(a)
shall not be construed to create a limit of EXACT’s liability with respect to
its indemnification obligation under Section 8.1 of this Agreement.


 


(b)           Genzyme shall, at its sole cost and expense,
procure and maintain commercial general liability insurance, applicable
worldwide, in amounts not less than [********] per incident and [********]
annual aggregate and naming the EXACT Indemnitees as additional insureds. Such
commercial general liability insurance shall provide (i) product liability
coverage and (ii) contractual liability coverage for Genzyme’s
indemnification under Section 8.2 of this Agreement. If Genzyme elects to
self-insure all or part of the limits described above (including deductibles or
retentions that are in excess of [********] annual aggregate) such
self-insurance program must be acceptable to EXACT. The minimum amounts of
insurance coverage required under this Section 8.4(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.


 


20

















 


shall not be construed to create a limit of
Genzyme’s liability with respect to its indemnification obligation under Section 8.2
of this Agreement.


 


(c)           Each party shall provide the other with
written evidence of such insurance upon request of the other party. Each party
shall provide the other with written notice at least thirty (30) days prior to
the cancellation, non-renewal or material change in such insurance. If such
party does not obtain replacement insurance providing comparable coverage
within such thirty (30) day period, the other party shall have the right to
terminate this Agreement and the rights, privileges and license granted
hereunder effective at the end of such thirty (30) day period without any notice
or additional waiting periods.


 


(d)           Each party shall maintain such comprehensive
general liability insurance beyond the expiration or termination of this
Agreement during (a) the period that any process, service or product
relating to, or developed pursuant to, this Agreement is being made available
(other than for the purpose of obtaining regulatory approvals) by EXACT and (b) a
reasonable period after the period referred to in clause (a) above which
in no event shall be less than fifteen (15) years.


 


ARTICLE 9.  REPRESENTATIONS,
WARRANTIES AND DISCLAIMERS


 


9.1.          (a)           Genzyme hereby represents and warrants to
EXACT that it has the right and power to enter into this Agreement, to extend
the rights and licenses granted herein and to perform its obligations hereunder,
and that this Agreement is a valid and binding agreement, enforceable in
accordance with its terms.


 


(b)           Genzyme further represents and warrants to
EXACT that Genzyme is not in material breach of the JHU License Agreement as of
the Original Effective Date, and that Genzyme will use commercially reasonable
and diligent efforts to comply with all of its material obligations and duties
with regard to the Patent Rights under the JHU License Agreement, including
without limitation any provisions of the JHU Agreement as may be reasonably
necessary to maintain in effect this Agreement or preserve EXACT’s rights under
this Agreement, including without limitation the preservation of EXACT’s rights
hereunder in the event that Genzyme shall breach or default on its obligations
under the JHU License Agreement.


 


(c)           EXACT hereby represents and warrants to
Genzyme that it has the right and power to enter into this Agreement and to
perform its obligations hereunder, and that this Agreement is a valid and
binding agreement, enforceable in accordance with its terms. EXACT agrees that
it shall comply with all applicable local, state, Federal and international
laws and regulations relating to the development, design, manufacture, sale,
use in commerce and promotion of Diagnostic Services, Licensed Reagents and
Kits.


 


9.2.          EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN SECTION 9.1, GENZYME MAKES NO WARRANTY, EXPRESS OR
IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR 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.


 


21

















 


FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT
TO ANY PATENT, TRADEMARK, SOFTWARE, NONPUBLIC OR OTHER INFORMATION, OR TANGIBLE
RESEARCH PROPERTY, LICENSED OR OTHERWISE PROVIDED TO EXACT HEREUNDER AND HEREBY
DISCLAIMS THE SAME.


 


9.3.          GENZYME DOES NOT WARRANT
THE VALIDITY OF THE PATENT RIGHTS LICENSED HEREUNDER AND MAKES NO
REPRESENTATION WHATSOEVER WITH REGARD TO THE SCOPE OF THE LICENSED PATENT
RIGHTS OR THAT SUCH PATENT RIGHTS MAY BE EXPLOITED BY EXACT WITHOUT
INFRINGING OTHER PATENTS.


 


9.4.          NOTWITHSTANDING ANY
OTHER PROVISION OF THIS AGREEMENT, EACH OF THE PARTIES HERETO DISCLAIMS ALL
OBLIGATIONS ON THE PART OF SUCH PARTY FOR DAMAGES, INCLUDING BUT NOT
LIMITED TO DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND
EXPERTS’ FEES AND EXPENSES, AND COURT COSTS (EVEN IF SUCH PARTY HAS BEEN
ADVISED OF THE PROBABILITY OF SUCH DAMAGES, FEES, EXPENSES AND COSTS) ARISING
OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, SALE OR PROVISION OF THE
LICENSED REAGENTS, DIAGNOSTIC SERVICES UTILIZING THE LICENSED PROCESSES AND
KITS BY THE OTHER PARTY. EXACT ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY
LOSS OR DAMAGES CAUSED BY A LICENSED REAGENT, DIAGNOSTIC SERVICE OR KIT
MANUFACTURED, USED, SOLD OR PROVIDED BY EXACT. GENZYME ASSUMES ALL
RESPONSIBILITY AND LIABILITY FOR ANY LOSS OR DAMAGES CAUSED BY A LICENSED
REAGENT, DIAGNOSTIC SERVICE OR KIT MANUFACTURED, USED, SOLD OR PROVIDED BY
GENZYME.


 


ARTICLE 10.  NOTICES


 


10.1.        Any consent, notice or
report required or permitted to be given or made under this Agreement shall be
in writing, delivered (i) by certified or registered mail (postage prepaid,
return receipt requested), (ii) by facsimile (and promptly confirmed by
personal delivery, courier or next business day service of a nationally recognized
courier service of good repute), (iii) by a next business day service of a
nationally recognized courier service of good repute (with evidence of
delivery) or (iv) by courier (postage prepaid and signature required), and
in any case addressed to the other party at its address set forth in this Article 10,
and shall be effective upon receipt by the addressee.


 


10.2.        Reports, notices and other
communications from EXACT to Genzyme as provided hereunder shall be sent 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.


 


22

















 


	
   

  	
  Genzyme Genetics

  	
   

  
	
   

  	
  1700 West Park
  Drive

  	
   

  
	
   

  	
  Westborough,
  Massachusetts 01581

  	
   

  
	
   

  	
  Attn:

  	
  Sr. Vice
  President & General Manager

  
	
   

  	
  Fax:

  	
  (508) 870-7504

  
	
   

  	
  Phone:

  	
  (508) 870-5232

  
	
   

  	
   

  	
   

  
	
   

  	
  with a copy to:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Genzyme
  Corporation

  	
   

  
	
   

  	
  500 Kendall
  Street

  	
   

  
	
   

  	
  Cambridge,
  Massachusetts 02142

  	
   

  
	
   

  	
  Attn:

  	
  General Counsel

  
	
   

  	
  Fax:

  	
  (617) 252-7553

  
	
   

  	
  Phone:

  	
  (617) 252-7500

  
				



 


or to such other individual or address as
shall hereafter be furnished by written notice to EXACT in accordance with this
Article 10.


 


10.3.        Reports,
notices and other communications from Genzyme to EXACT as provided hereunder
shall be sent to:


 


	
   

  	
  EXACT Sciences
  Corporation

  
	
   

  	
  100 Campus Drive

  
	
   

  	
  Marlborough,
  Massachusetts 01752

  
	
   

  	
  Attn:

  	
  Chief Executive
  Officer

  
	
   

  	
  Fax:

  	
  (508) 683-1201

  
	
   

  	
  Phone:

  	
  (508) 683-1200

  
	
   

  	
   

  	
   

  
	
   

  	
  with a copy to:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Goodwin|Procter
  LLP

  	
   

  
	
   

  	
  53 State Street

  	
   

  
	
   

  	
  Boston,
  Massachusetts 02109

  	
   

  
	
   

  	
  Attn:

  	
  Edward A.
  King, Esq. & Kingsley L. Taft, Esq.

  
	
   

  	
  Fax:

  	
  (617) 523-1231

  
	
   

  	
  Phone:

  	
  (617) 570-1000

  
				



 


or to such other individual or address as
shall hereafter be furnished by written notice to Genzyme in accordance with
this Article 10.


 


ARTICLE 11.  ARBITRATION


 


11.1.        Any
controversy or claim arising out of, or relating to any provisions of this
Agreement or the breach thereof which cannot otherwise be resolved by good
faith negotiations between the parties, or by any form of Alternate Dispute
Resolution other than arbitration 


 


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

















 


which may be mutually acceptable to the
parties, shall be resolved by final and binding arbitration in Boston,
Massachusetts under the rules of the American Arbitration Association, or
the Patent Arbitration Rules if applicable, then obtaining.


 


The arbitration shall be subject to the
following terms:


 


(a)           The number of arbitrators shall be one (1).


 


(b)           The arbitrator shall be an independent,
impartial third party having no direct or indirect personal or financial
relationship to any of the parties to the dispute, who has agreed to accept the
appointment as arbitrator on the terms set out in this Section 11.1.


 


(c)           The arbitrator shall be an active or retired
attorney, law professor, or judicial officer with at least five (5) years
experience in the biotechnology or pharmaceuticals industries and a familiarity
with the laws governing proprietary rights in intellectual property.


 


(d)           The arbitrator shall be selected as follows:


 


(i)            Each party shall
submit a description of the matter to be arbitrated to the American Arbitration
Association at its Regional Office in Boston, Massachusetts. Said Association
shall submit to the parties a list of the arbitrators available to arbitrate
any dispute between them. Thereafter, each party shall select, in numerical
order, those persons on said list acceptable as arbitrators and return the same
to the Association. The first arbitrator acceptable to both parties shall be
deemed the selected arbitrator with respect to the dispute then at issue under
this Agreement. In the event of a failure to select a mutually agreeable
arbitrator, the Association shall be requested to submit as many subsequent
lists of arbitrators as shall be necessary to effect a mutual selection.


 


(ii)           If the method of
selection set out in paragraph (d)(i) above fails for any reason, then
either party may petition any state or federal court in Massachusetts having
jurisdiction for appointment of the arbitrator in accordance with applicable
law, provided that the arbitrator must satisfy the requirements of paragraphs (b)
and (c) above.


 


(e)           The arbitrator shall announce the decision
and/or award in writing accompanied by written findings explaining the facts
determined in support of the decision and/or award, and any relevant
conclusions of law.


 


(f)            Unless otherwise provided in this Section 11.1
or extended by agreement of the parties, each party shall submit an initial
request for designation of an arbitrator within thirty (30) days after receipt
of the first list of available arbitrators pursuant to Section 11.1 (d) of
this Agreement, the dispute shall be submitted to the arbitrator 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.


 


24

















 


(90) days after the arbitrator is selected,
and a decision shall be rendered within thirty (30) days after the dispute is
submitted.


 


(g)           The fees of the arbitrator and any other
costs and fees associated with the arbitration shall be paid in accordance with
the decision of the arbitrator.


 


(h)           The arbitrator shall have no power to add
to, subtract from, or modify any of the terms or conditions of this Agreement.
Any award rendered in such arbitration may be enforced by either party in
either the courts of the Commonwealth of Massachusetts, or in the United States
District Court for the District of Massachusetts, to whose jurisdiction for
such purposes Genzyme and EXACT each hereby irrevocably consents and submits.


 


11.2.        Notwithstanding the
foregoing, nothing in this Article shall be construed to waive any rights
or timely performance of any obligations existing under this Agreement.


 


ARTICLE 12.  RESTRICTIONS ON USE
OF NAMES


 


12.1.        EXACT shall not use the
name of Genzyme or its divisions, JHU, JHHS or their respective directors,
officers, trustees, affiliates, employees, faculty, students and the inventor(s) of
the Patent Rights or any adaptations or contractions thereof in any
advertising, promotional or sales literature without the prior written consent
of Genzyme or JHU in each case, as applicable; provided,
however, that EXACT (a) may refer
to publications by employees of Genzyme in the scientific literature and (b) may
state that a license from Genzyme has been granted as herein provided. With
respect to reports to public agencies that are required by law, EXACT shall
provide Genzyme with a reasonable opportunity to review the use of its name in
each such report reasonably in advance of its submission.


 


12.2.        EXACT shall not disclose
this Agreement or any of the terms or conditions of this Agreement to any third
party without the prior written consent of Genzyme except and to the extent
required to comply with applicable laws or regulations; provided,
that EXACT delivers prior written notice to Genzyme of any disclosure required
by applicable laws or regulations and takes all reasonable and lawful actions
to obtain confidential treatment for such disclosure and, if possible, to
minimize the extent of such disclosure.


 


ARTICLE 13.  CONFIDENTIALITY


 


13.1.        During the term of this
Agreement, each party (the “Disclosing Party”) may communicate to the
other party (the “Receiving Party”) information which it considers to be
confidential (“Confidential Information”). All Confidential Information
shall be specifically designated as confidential. Such Confidential Information
may include, without limitation, trade secrets, know-how, inventions, technical
data or specifications, testing methods, business or financial information,
research and development activities, product and marketing plans, and customer
and supplier information. Confidential Information that is disclosed in writing
shall be marked with a legend indicating its confidential status. Confidential
Information that is disclosed orally or visually shall be 


 


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

















 


documented in a written notice prepared by
the Disclosing Party and delivered to the Receiving Party within thirty (30)
days of the date of disclosure; such notice shall summarize the Confidential
Information disclosed to the Receiving Party and reference the time and place
of disclosure.


 


13.2.        The Receiving Party agrees
that it shall: (a) maintain all Confidential Information in strict
confidence, except that the Receiving Party may disclose or permit the
disclosure of any Confidential Information to its directors, officers,
employees, consultants and advisors who are obligated to maintain the
confidential nature of such Confidential Information and who need to know such
Confidential Information for the purposes set forth in this Agreement; (b) use
all Confidential Information solely for the purposes set forth in this
Agreement; and (c) allow its directors, officers, employees, consultants
and advisors to reproduce the Confidential Information only to the extent
necessary to effect the purposes set forth in this Agreement, with all such
reproductions being considered Confidential Information.


 


13.3.        The obligations of the
Receiving Party under Section 13.2 above shall not apply to the extent
that the Receiving Party can demonstrate that certain Confidential Information:
(a) was in the public domain prior to the time of its disclosure under
this Agreement; (b) entered the public domain after the time of its
disclosure under this Agreement through means other than an unauthorized
disclosure resulting from an act or omission by the Receiving Party; (c) was
independently developed or discovered by the Receiving Party without use of the
Confidential Information; (d) is or was disclosed to the Receiving Party
at any time, whether prior to or after the time of its disclosure under this
Agreement, by a third party having no fiduciary relationship with the
Disclosing Party and having no obligation of confidentiality with respect to
such Confidential Information; or (e) is required to be disclosed to
comply with applicable laws or regulations, or with a court or administrative
order, provided, that the Disclosing Party receives prior written notice of
such disclosure and that the Receiving Party takes all reasonable and lawful
actions to obtain confidential treatment for such disclosure and, if possible,
to minimize the extent of such disclosure.


 


13.4.        The obligations set forth
in this Article 13 shall remain in effect for a period of five (5) years
after the expiration or the earlier termination of this Agreement.


 


ARTICLE 14.  PATENT MARKING


 


14.           EXACT agrees to mark any Kits, Licensed
Reagents or promotional materials, technical literature and the like that
describe Kits, Licensed Reagents or Diagnostic Services with all applicable
patent numbers, and to indicate “Patent Pending” status in accordance with each
applicable country’s patent laws.


 


ARTICLE 15.  INDEPENDENT
CONTRACTOR


 


15.           For the purpose of this Agreement and all
services to be provided hereunder, both parties shall be, and shall be deemed
to be, independent contractors and not agents or employees 


 


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

















 


of the other. Neither party shall have
authority to make any statements, representations or commitments of any kind,
or to take any action, that will be binding on the other party.


 


ARTICLE 16.  SEVERABILITY


 


16.           If any one or more of the provisions of this
Agreement shall be held to be invalid, illegal or unenforceable, the validity,
legality or enforceability of the remaining provisions of this Agreement shall
not in any way be affected or impaired thereby unless the invalid provisions
are of such essential importance to this Agreement that it is to be reasonably
assumed that the parties would not have entered into this Agreement without the
invalid provisions.


 


ARTICLE 17.  NON-ASSIGNABILITY


 


17.           Neither this Agreement nor any part hereof
shall be assignable by either party without the express prior written consent
of the other, which shall not be unreasonably withheld. Any attempted
assignment without such consent shall be void. Notwithstanding the foregoing,
such consent shall not be required for the assignment of this Agreement (i) by
EXACT in connection with the sale or transfer of all or substantially all of
the business or assets of EXACT however structured, or (ii) by Genzyme in
conjunction with the transfer of all or substantially all of the business or
assets of Genzyme or all or substantially all of the business or assets
allocated to its Molecular Oncology Division however structured; provided, in any such case, that the assignor promptly
notifies the other party hereto of such assignment and the assignee assumes all
of the assignor’s obligations hereunder in writing, with a copy of such written
assumption (which may be redacted to the extent reasonably necessary to protect
confidential information) to be promptly delivered to the other party hereto.


 


ARTICLE 18.  NON-SOLICITATION


 


18.           During the term of this Agreement and during
the period ending [********] after the expiration or earlier termination of
this Agreement, neither party shall, without the prior written consent of the
other, solicit the employment of, or employ, any person in any capacity who, at
any time during the term of this Agreement, shall have been an employee of the
other party.


 


ARTICLE 19.  ENTIRE AGREEMENT


 


19.           This Agreement constitutes the entire
agreement between the parties with respect to the subject matter and supersedes
any prior agreements and understandings between the parties relating to the
subject matter hereof. No oral agreement, conversation or representation
between any officers, agents or employees of the parties hereto either before
or after the Effective Date of this Agreement shall affect or modify any of the
terms or obligations herein contained.


 


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
















 


ARTICLE 20. 
MODIFICATIONS IN WRITING


 


20.                               No
change, modification, extension, termination or waiver of this Agreement, or
any of the provisions herein contained, shall be valid unless made in writing
and signed by a duly authorized representative of each party.


 


ARTICLE 21. 
GOVERNING LAW


 


21.                               The
validity and interpretation of this Agreement and the legal relations of the
parties to it shall be governed by the laws of the Commonwealth of
Massachusetts without regard to the conflict of laws provisions thereunder.


 


ARTICLE 22. 
CAPTIONS


 


22.                               The
captions are provided for convenience and are not to be used in construing this
Agreement.


 


ARTICLE 23. 
CONSTRUCTION


 


23.                               Each
of the parties agree that this Agreement is the result of mutual negotiation
and therefore the language herein shall not be presumptively construed against
either of them.  The term “including” as used herein shall mean including, without
limiting the generality of any description preceding such term.


 


ARTICLE 24. 
COUNTERPARTS


 


24.                               This
Agreement may be executed in one or more counterparts, each of which shall be
deemed to be an original, and all of which together shall be deemed to be one
and the same instrument.


 


ARTICLE 25. 
BINDING EFFECT


 


25.                               This
Agreement shall be binding upon and inure to the benefit of the parties and
their respective permitted successors and permitted assigns.


 


ARTICLE 26. 
FORCE MAJEURE


 


26.                               Neither
party shall be deemed to be in breach of this Agreement due to, or liable to
the other party for damages or loss occasioned by failure of performance by the
defaulting party if the failure is occasioned by war, fire, explosion, flood,
acts of God, strike or lockout, embargo, or any similar cause beyond the
control of the defaulting party; provided that the party claiming this
exception has exerted all commercially reasonable and diligent efforts to avoid
or remedy such event and that such event does not extend for more than nine (9) months;
provided further that such party provides the other party with prompt written
notice of any delay or failure to perform that occurs by reason of force
majeure and continues performance hereunder with reasonable dispatch whenever
such causes are removed. The parties shall mutually seek a resolution of the
delay or failure 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.


 


28

















 


perform in good faith if a force majeure
event extends for more than nine (9) months, which resolution may be
termination of this Agreement.


 


ARTICLE 27. 
JHU LICENSE AGREEMENT


 


27.                               In
the event that Genzyme’s license to the Patent Rights under the JHU License
Agreement is terminated, this Agreement shall remain in effect pursuant to the
terms of the JHU License Agreement provided that at such time EXACT is not in
material breach of the provisions of this Agreement and agrees to be bound to
JHU as a licensor under the terms and conditions of this Agreement.


 


[REMAINDER OF PAGE
INTENTIONALLY LEFT BLANK]


 


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

















 


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


 


 


	
  GENZYME CORPORATION

  	
  EXACT SCIENCES CORPORATION

  
	
   

  	
   

  
	
  By:

  	
  /s/ Earl M. Collier, Jr.

  	
   

  	
  By:

  	
  /s/ Jeffrey R. Luber

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name

  	
  Earl M. Collier, Jr.

  	
   

  	
  Name

  	
  Jeffrey R. Luber

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Executive Vice President

  	
   

  	
  Title:

  	
  President and Chief Executive Officer

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  January 27, 2009

  	
   

  	
  Date:

  	
  January 27, 2009

  



 


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.


 

















 


Appendix A


 


Gene 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.


 

















 


Appendix B


 


Methodology 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.