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 2
nd through 5 th 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.
2
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 du
