Exhibit 10.2


 


ASSIGNMENT, SUBLICENSE, CONSENT AND


EIGHTH AMENDMENT TO LICENSE AGREEMENT


 


This
ASSIGNMENT, SUBLICENSE, CONSENT AND EIGHTH AMENDMENT TO LICENSE AGREEMENT (this
“ASSIGNMENT, SUBLICENSE AND AMENDMENT”) is made and entered into as of January 27,
2009, by and among EXACT Sciences Corporation, a Delaware corporation (“EXACT”),
Genzyme Corporation, a Massachusetts corporation (“GENZYME”) and Johns Hopkins
University, a Maryland corporation (“JHU”). Unless otherwise indicated, all
capitalized terms used herein and not otherwise defined shall have the meanings
given them in the AGREEMENT (as defined below).


 


WHEREAS, EXACT and GENZYME are parties to
that certain Collaboration, License and Purchase Agreement, dated as of January 27,
2009 (the “CLP AGREEMENT”), pursuant to which, among other things, EXACT is to
sell to GENZYME, and GENZYME is to purchase from EXACT, the Purchased Assets
(as the term is defined in the CLP AGREEMENT);


 


WHEREAS, pursuant to the CLP AGREEMENT, EXACT
has agreed to assign to GENZYME that certain Amended and Restated License
Agreement having a final signature date of March 25, 2003, by and between
EXACT Laboratories, Inc. (now known as EXACT) and JHU, as amended (the “AGREEMENT”),
and GENZYME has agreed to assume EXACT’s obligations under the AGREEMENT, as
set forth herein; and


 


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


 


NOW, THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the parties hereto agree as follows:


 


1.             Assignment.
EXACT hereby transfers and assigns to GENZYME all of EXACT’s right, title and
interest in, to and under, the AGREEMENT, to have and to hold the same unto
GENZYME and its successors and assigns from and after the date hereof subject
to the covenants, conditions and provisions therein provided. EXACT, GENZYME
and JHU agree that Exhibit 1 attached hereto contains a complete list of
all amendments to the AGREEMENT prior to the date hereof.


 


2.             Assumption.
GENZYME hereby accepts the transfer and assignment of the AGREEMENT, and
GENZYME hereby agrees to pay, defend, discharge and perform all obligations
under the AGREEMENT arising from and after the closing of the CLP AGREEMENT
(the “CLOSING”).


 


3.             Consent.
Contingent upon the Closing, JHU hereby consents to (a) the transfer and
assignment of the AGREEMENT by EXACT to GENZYME such that upon such transfer
and assignment, all references to EXACT (whether as EXACT or COMPANY) in the
AGREEMENT shall be references to GENZYME and (b) the sublicense by GENZYME
to EXACT of certain rights under the AGREEMENT pursuant to Section 4 below
(the “SUBLICENSE”). JHU’s consent to the transfer and assignment of the
AGREEMENT shall
not be construed either as a consent by JHU to, or as permitting, any other or
further assignment 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.


 

















 


the AGREEMENT, whether in whole or in part,
or as a waiver of the requirement of obtaining JHU’s consent thereto.
To the best of JHU’s knowledge, EXACT is not in breach of the AGREEMENT as of
the date first set forth above.


 


4.             Sublicense.


 


(a)           Subject to the terms
and conditions of the AGREEMENT, and expressly subject to Article 2.3
therein, and subject to the terms and conditions of this Section 4,
GENZYME hereby grants to EXACT the following sublicenses, under the license
grants by JHU in the AGREEMENT, solely in the EXACT FIELD, as defined below:


 


(i)            an exclusive license
under the PATENT RIGHTS to make, have made, use, have used, sell, have sold,
import, and have imported any method or product worldwide, solely in the FIELD,
as the “FIELD” may be limited in the AGREEMENT with respect to particular
PATENT RIGHTS;


 


(ii)           an exclusive license
under the BEAMING PATENT RIGHTS in the BEAMING EXCLUSIVE FIELD to make, have
made, use, have used, sell, have sold, import, and have imported any method,
service or product worldwide; and


 


(iii)          a non-exclusive license
under the BEAMING PATENT RIGHTS in the BEAMING NONEXCLUSIVE FIELD to make, have
made, use, have used, sell, have sold, import, and have imported any method,
service or product worldwide.


 


(b)           EXACT (and its
sublicensees) shall have the right to grant further sublicenses under the
foregoing sublicenses to EXACT provided that any such sublicenses comply with
the terms of the AGREEMENT and further provided that GENZYME will have, along with
JHU, the review rights under the 2nd through 5th sentences of Section 2.2
of the AGREEMENT regarding any such sublicenses.


 


(c)           “EXACT FIELD” means (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 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.  For the purposes of
this definition, (1) “FDA KITS” 


 


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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means a collection of one or more reagents,
packaged in the form of a kit that has received approval from the U.S. Food and
Drug Administration (“FDA”) or any equivalent foreign regulatory agency or
body, and (2) FECAL BASED TESTS as defined in the AGREEMENT are within the
EXACT FIELD.


 


(d)           EXACT hereby
acknowledges and agrees to be bound by and comply with, and to cause any
sublicensees of EXACT to comply with, as if EXACT and those sublicensees were
GENZYME under the AGREEMENT, the following sections of the AGREEMENT: 2.3
(Retained Rights), 5.2 (Records), 6.1 (Representations by JHU), 7.1
(Indemnification), 8 (Confidentiality), 9.4 (Obligations and Duties upon
Termination), 10.1 (Use of Name), 10.4 (Product Liability), and 10.19 (Howard
Hughes Medical Institute).  In addition,
as between GENZYME and EXACT, EXACT agrees to be responsible for and perform
all obligations of GENZYME as licensee under the AGREEMENT to the extent
relating to the EXACT FIELD. 
Notwithstanding the foregoing, GENZYME will remain solely responsible
for all obligations under ARTICLE 4 of the AGREEMENT (PATENT PROSECUTION).


 


(e)           During such time as the
SUBLICENSE is in effect, EXACT will pay to GENZYME (i) [********] due to
JHU with respect to activities in the EXACT FIELD (including [********] due
with respect to FECAL BASED TESTS) and (ii) [********] due to JHU pursuant
to the AGREEMENT (as may be further amended from time to time) (collectively,
the “EXACT JHU PAYMENT”). GENZYME shall remit the EXACT JHU PAYMENT to JHU,
together with other amounts payable by GENZYME under the AGREEMENT. GENZYME and
not EXACT will be solely responsible for (1) [********], and (2) all
amounts owed to JHU under the AGREEMENT for [********]. For the avoidance of
doubt, except as explicitly specified herein, amounts due with respect to
activities in the EXACT FIELD will be calculated in the same manner as they
were prior to the execution of this ASSIGNMENT, SUBLICENSE AND AMENDMENT, as if
EXACT were the direct licensee of JHU.


 


(f)            EXACT will provide
GENZYME with all assistance reasonably requested to allow GENZYME to meet its
reporting obligations under the AGREEMENT, including furnishing within 15 days
after the end of March 31st, June 30th, September 30th and December 31st
each year (or on such other dates as reasonably requested by GENZYME) a written
report with respect to the preceding 3 month period providing detail reasonably
satisfactory to GENZYME to calculate the amounts due to JHU pursuant to the
AGREEMENT.


 


(g)           Within 60 days after
the end of each calendar year, GENZYME and EXACT will agree in good faith in
writing on the amount of the EXACT JHU PAYMENT due with respect to such
year.  EXACT will remit to GENZYME the
total EXACT JHU PAYMENT due for such year in two equal payments made on or
before June 30th and December 31st of the 


 


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


 


3

















 


following year.  In the event that the amount actually paid by
GENZYME to JHU with respect to activities in the EXACT FIELD in a calendar year
is different than the parties had assumed in calculating the JHU EXACT PAYMENT,
the parties will negotiate in good faith a reasonable adjustment to such JHU
EXACT PAYMENT and such adjustment will promptly be corrected by a payment or
refund, as appropriate.


 


(h)           GENZYME may terminate
the SUBLICENSE any time by giving written notice to EXACT in the event that
EXACT fails to materially perform or otherwise materially breaches its
obligations under the SUBLICENSE (including under Section 4(e) of
this ASSIGNMENT, SUBLICENSE AND AMENDMENT) and such failure remains uncured for
45 days, measured from the date written notice of such failure is given to
EXACT.


 


(i)            EXACT’s failure to
perform under the SUBLICENSE shall not be a breach by GENZYME of the AGREEMENT,
but rather, shall give JHU the right to terminate the SUBLICENSE on the terms
and conditions set forth in the AGREEMENT.


 


(j)            If the AGREEMENT is
terminated and at such time EXACT is then in good standing under the AGREEMENT,
JHU hereby grants to EXACT a direct license on substantially the same terms as
EXACT has as a sublicensee of GENZYME, so that EXACT would be put in the same
position as it was prior to such AGREEMENT termination, provided that JHU will
not have any increased obligations as a result of such direct license to
EXACT.  If such a direct license goes
into effect, EXACT and JHU agree to memorialize in writing such direct license
promptly.


 


(k)           GENZYME, EXACT and JHU
each agrees to provide the other parties hereto with copies of any notices
given under the AGREEMENT to the extent relating to the EXACT FIELD and the
SUBLICENSE.


 


5.             Amendments.


 


(a)           EXACT, GENZYME and JHU
hereby delete the definition of SECOND BEAMING EXCLUSIVE FIELD in the AGREEMENT
and replace it in its entirety with the following:


 


SECOND BEAMING EXCLUSIVE FIELD, for
the purposes of the BEAMING PATENT RIGHTS only, shall mean [********]:


 


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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(b)           Notwithstanding
anything to the contrary in the AGREEMENT, EXACT, and not GENZYME, will be
solely responsible for the diligence obligations of GENZYME (as licensee under
the AGREEMENT) in the EXACT FIELD, as contained in Section 5.3 of the
AGREEMENT, to the extent relating to the EXACT FIELD.  Notwithstanding the foregoing, Genzyme will
remain solely responsible for all obligations under ARTICLE 4 of the
AGREEMENT (PATENT PROSECUTION).


 


(c)           EXACT, GENZYME and JHU
hereby delete Sections 1.12.1(a) and 1.12.2(a) of the AGREEMENT and
replace them in their entirety with the following:


 


[********]


 


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


 


(d)           EXACT, GENZYME and JHU
hereby delete Section 10.8 of the AGREEMENT and replace it in its entirety
with the following:


 


Neither this Agreement nor any of the rights or obligations created
herein, except for the right to receive any remuneration hereunder, may be
assigned by either party, in whole or in part, without the prior written
consent of the other party. Notwithstanding the preceding sentence, JHU and
COMPANY shall be free to assign this Agreement in connection with any sale of
substantially all of such party’s assets to which this Agreement relates
without the consent of the other party hereunder, and COMPANY and JHU shall be
free to assign this Agreement or otherwise to transfer all of their respective
rights and obligations under this Agreement to a successor by merger without
the consent of the other party hereunder. This Agreement shall bind and inure
to the benefit of the successors and permitted assigns of the parties hereto.


 


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

















 


(e)           EXACT, GENZYME and JHU
agree to amend the second sentence of Section 2 of the Fifth Amendment to the
AGREEMENT, [********] from the date of this ASSIGNMENT, SUBLICENSE AND
AMENDMENT.  EXACT, GENZYME and JHU agree
further to delete the last sentence of Section 2 of the Fifth Amendment to the
AGREEMENT and replace it in its entirety with the following:


 


GENZYME may exercise the BEAMING OPTION granted hereunder by providing
to JHU, prior to the end of the option period: (a) written Notice of its
intent, and, (b) a written statement  of its commercially reasonable
plans and apabilities to develop a product or service in the SECOND BEAMING
EXCLUSIVE FIELD for public use or benefit.


 


6.             Upfront Payment.  GENZYME will pay [********] to JHU within 15
business days of the execution of this ASSIGNMENT, SUBLICENSE AND AMENDMENT.


 


7.             Option Exercise
Payment. GENZYME will pay [********] to JHU within 30 business days of
exercising the BEAMING OPTION.


 


8.             Milestones.


 


(a)           GENZYME shall pay to
JHU the following one-time event milestone payments:


 


(i)            [********]


 


(ii)           [********]


 


(b)           GENZYME shall pay to
JHU the following one-time sales milestone payments:


 


(i)            [********]


 


(ii)           [********]


 


(iii)          [********]


 


(c)           Once GENZYME has made
any particular milestone payment under Section 8(a) or 8(b), GENZYME
will not be obligated to make any payment with respect to the re-occurrence of
the same milestone.


 


9.             Miscellaneous.


 


(a)           This ASSIGNMENT,
SUBLICENSE AND AMENDMENT shall be binding upon and shall inure to the benefit
of the parties hereto, their respective successors, assigns, and legal
representatives. Neither this ASSIGNMENT, SUBLICENSE AND AMENDMENT nor any
interest or obligation hereunder is assignable (i) by EXACT without the
prior written consent of GENZYME , provided, however, that EXACT shall be free
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.


 


6

















 


assign this ASSIGNMENT, SUBLICENSE AND
AMENDMENT in connection with any merger, reorganization, or transfer of all or
substantially all assets of EXACT or other change in control of EXACT; (ii) by
GENZYME, other than in connection with an assignment of the AGREEMENT permitted
under Section 10.8 of the AGREEMENT (Successors and Assigns).


 


(b)           This ASSIGNMENT,
SUBLICENSE AND AMENDMENT may not be orally changed, modified or terminated, nor
shall any oral waiver of any of its terms be effective.  This ASSIGNMENT, SUBLICENSE AND AMENDMENT may
be changed, modified or terminated only by an agreement in writing signed by
EXACT, JHU and GENZYME.


 


(c)           This ASSIGNMENT,
SUBLICENSE AND AMENDMENT may be executed in separate and several counterparts,
each of which shall be an original, but which together shall constitute one and
the same instrument.


 


(d)           This ASSIGNMENT,
SUBLICENSE AND AMENDMENT will only supersede the AGREEMENT to the extent that
this Amendment and the AGREEMENT conflict. In the event of a conflict between
this ASSIGNMENT, SUBLICENSE AND AMENDMENT and the AGREEMENT, then this
ASSIGNMENT, SUBLICENSE AND AMENDMENT will control. Except as otherwise provided
in this ASSIGNMENT, SUBLICENSE AND AMENDMENT, all terms of the AGREEMENT shall
remain in full force and effect.


 


(e)           This ASSIGNMENT,
SUBLICENSE AND AMENDMENT, and all disputes, actions or proceedings arising out
of or relating to this ASSIGNMENT, SUBLICENSE AND AMENDMENT, shall be governed
by and construed in accordance with the laws of the State of Delaware, without
regard to its conflict of laws provisions.


 


[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.


 


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IN WITNESS WHEREOF, each of the undersigned has executed this
Assignment, Sublicense, Consent and Eighth Amendment to License Agreement as of
the date first set forth above.


 


 


	
   

  	
  EXACT SCIENCES CORPORATION

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Jeffrey R. Luber

  
	
   

  	
   

  	
  Name: Jeffrey R. Luber

  
	
   

  	
   

  	
  Title: President and Chief Executive Officer

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  JOHNS HOPKINS UNIVERSITY

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Wesley D. Blakeslee

  
	
   

  	
   

  	
  Name: Wesley D. Blakeslee

  
	
   

  	
   

  	
  Title: Executive Director

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  GENZYME CORPORATION

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Earl M. Collier, Jr.

  
	
   

  	
   

  	
  Name: Earl M. Collier, Jr.

  
	
   

  	
   

  	
  Title: Executive Vice President

  



 


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.


 

















 


Exhibit 1


 


Amendments to AGREEMENT:


·      Second Amendment, effective
as of November 9, 2004


·      Third Amendment, effective
as of May 11, 2006


·      Fourth Amendment, effective
as of March 19, 2007


·      Fifth Amendment, effective
as of October 17, 2008


·      Sixth Amendment, effective
as of October 30, 2008


·      Seventh Amendment, effective
as of December 15, 2008


 


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.