Exhibit 10.13
SUBLICENSE AGREEMENT
This Sublicense Agreement (the
“Agreement”) is entered into as of July 28th, 2003 (the
“Effective Date”) by and between Beckman Coulter, a
Delaware corporation, having a principal place of business at 4300
North Harbor Boulevard, Fullerton, California 92835
(“BECKMAN”), and EXACT Sciences Corporation, a Delaware
corporation having a principal place of business at 100 Campus
Drive, Marlborough, Massachusetts 01754
(“EXACT”).
In consideration of the mutual
promises and conditions contained in this Agreement, BECKMAN and
EXACT agree as follows:
ARTICLE 1 - DEFINITIONS
1.1
“Affiliate” shall mean
any company, corporation or other business entity that is
controlled by, controlling, or under common control with the
subject company, corporation or other business. For this purpose
“control” means direct or indirect beneficial ownership
of at least fifty percent (50%) interest in the voting stock (or
the equivalent) of the company, corporation or other business or
having the right to direct, appoint or remove a majority of members
of its board of directors (or their equivalents) or having the
power to control the general management of the company, corporation
or other business, by law or contract.
1.2
“EXACT Net Revenues”
shall mean:
(i)
gross royalties received by EXACT
from its Sublicensee relating to the Third Party’s sale or
provision of Licensed Services, and
(ii)
gross revenues received by EXACT
relating to EXACT’s direct provision of Licensed Services,
less the following deductions:
(a)
Trade, quantity, cash or other
discounts, if any, actually allowed and taken;
(b)
Credits or allowances, not to exceed
two percent of EXACT Net Revenues, made or given on account of
defective services or
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disputed services that are
specifically identifiable to Licensed Services sold to a Third
Party; and
(c)
Any tax or governmental charge
received by EXACT from its customer with respect to the sale, use
or delivery of Licensed Services to the customer and paid by EXACT
to a governmental entity.
1.3
“Field” shall mean
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ used for /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/
Notwithstanding the foregoing, the
“Field” shall not include:
the provision of /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/ or the /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ for the provision of /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ that consist
of /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ for the
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ of samples of
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ to produce
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/
For the sake of clarity, the parties
confirm that the limitation set forth in paragraph (b) of this
definition in conjunction with the definition of Specialty Testing
operates within the Field to:
(i)
INCLUDE within the scope of this
license the ability of EXACT and its Sublicensee to provide to
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ for which the
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ does not require a
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or a /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/ (including those laboratory services
performed as /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or that are
based on /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/), and
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(ii)
EXCLUDE from the scope of this
license the ability of EXACT and its Sublicensee to sell products
or services for which /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/
requires a /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/
1.4
“Licensed Patents” shall
mean, individually and collectively, (i) the U.S.
patent(s) identified on Exhibit 1, attached hereto, and
any reissues, reexaminations, and extensions thereof, and all
Canadian patents or applications corresponding to any of the
foregoing; (ii) the U.S. patent applications identified on
Exhibit 1, and all Canadian patents or applications
corresponding thereto; (iii) all non-provisional,
continuation, continuation-in part, divisional and Canadian
applications that claim the priority, either directly or
indirectly, to any Licensed Patents described in subsection
(i) or (ii) above; and (iv) all United States and
Canadian patents issued on the Licensed Patents described in
subsection (ii) or (iii) above, and all reissues,
reexaminations and extensions thereof.
1.5
“Licensed Services”
shall mean services that but for this Agreement would infringe a
valid and enforceable claim in the Licensed Patents.
1.6
“Intellectual Property”
shall mean rights to patents, copyrights, trademarks, trade
secrets, proprietary information, know-how and technical data
(whether or not patentable) and all other intellectual property
rights, in each case whether registered or unregistered and
including applications for the grant of any of the foregoing and
all rights or forms of protection having equivalent or similar
effect to any of the foregoing which may subsist anywhere in the
world.
1.7
“License Term” shall
mean the period of time from the Effective Date of the Agreement
through expiration of the last to expire of the Licensed
Patents.
1.8
“Party” or
“Parties” shall mean BECKMAN and/or EXACT, as the
context requires.
1.9
“Sublicensee” shall mean
any entity to which EXACT has granted a sublicense of some or all
of the rights conveyed to EXACT under this Agreement.
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1.10
“Territory” shall mean
the United States and Canada.
1.11
“Test” shall mean a test
result per single patient derived from the provision of Licensed
Services.
1.12
“Third Party” means any
person or entity other than EXACT or BECKMAN.
1.13
/*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ means that patent license agreement signed by BECKMAN
and /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ on /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/
1.14
“Fluorescence
Polarization” means the process by which a fluorescent sample
is irradiated with plane-polarized excitation radiation and
components of a resultant fluorescent signal are separately
detected from the sample which are polarized respectively parallel
to and perpendicular to the plane of polarization of the excitation
radiation, either on a steady state or time resolved basis relative
to the excitation radiation, as and to the extent claimed in any
valid, maintained and enforceable U.S. or foreign patent issuing
from or claiming priority from U.S. Patent Application Serial
No. 09/137,826 entitled Fluorescence Polarization in Nucleic
Acid Analysis, filed August 20, 1998, owned or licensed by NEN
Life Science Products, Inc.
1.15
“Fluorescence Resonance Energy
Transfer” means the process by which a fluorescent sample
containing two distinct dyes wherein the sample is irradiated with
light energy optimal to excite the first of the two dyes and
wherein that first dye upon excitation transfers the energy to the
second dye specifically when both dyes are attached to the same
primer through a process whereby a nucleic acid template-dependent
primer extension reaction determines the identity of a single
nucleotide base at a specific position in a nucleic acid of
interest, which process is covered by U.S. Patent
No. 5,888,819 and 6,004,744 and any divisionals, continuation,
reissues and foreign counterparts thereof, and the fluorescence
emission of the second dye is detected at second wavelength, as and
to the extent claimed in U.S. Patent No. 5,945,283 entitled Methods
and Kits for Nucleic Acid Analysis Using Fluorescence Resonance
Energy Transfer, issued on
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December 17, 1996 and owned or
licensed by NEN Life Science Products, Inc., and any
divisionals, continuations, reissues and foreign counterparts
thereof and as and to the extent such NEN patents are valid,
maintained and enforceable.
1.16
“Specialty Testing”
means:
(a)
products and processes for the
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ of samples of human,
animal or vegetable origin, and
(b)
/*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ specific receptor proteins, ligands, nucleic acid
sequences, and similar reagents which /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ are intended for use in a diagnostic application for
/*/[CONFIDENTIAL TREATMENT REQUESTED]/*/
1.17
/*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ means:
(a)
in the case of the /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/ and
(b)
in the case of countries outside of
the United States, /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ with
similar responsibilities.
1.18
“Colorectal Cancer
Assay” means any /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/
(including but not limited to /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ testing).
ARTICLE 2 - GRANT OF LICENSES;
OWNERSHIP
2.1
LICENSE GRANT. Subject to the terms
and conditions of this Agreement, BECKMAN grants to EXACT a
non-exclusive, royalty-bearing license under the Licensed Patents
in the Field in the Territory during the License Term, to make,
have made, use, offer to sell, sell and import Licensed Services.
This license
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granted hereunder shall include a
limited right to sublicense as herein provided. Nothing in this
Agreement will be construed to grant to EXACT any license or rights
except under the Licensed Patents and within the Field.
2.2
SUBORDINATION TO /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/. This Agreement will not be construed to
grant EXACT (i) any rights that are broader then the rights
granted to BECKMAN under the /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ with regard to /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ (as that term is defined in the /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/; or (ii) a term of license that is
longer than the term of the /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/
2.3
SUBLICENSING. EXACT shall have the
right to sublicense the rights granted in Paragraph 2.1 above only
to Laboratory Corporation of America Holdings
(“LabCorp”), provided however, that no such sublicense
shall be effective until LabCorp executes a written sublicense
agreement (the “Sublicense Agreement”) with EXACT with
respect to the Licensed Services and provided that the terms of the
Sublicense Agreement are not inconsistent with and are subordinate
to the rights afforded EXACT hereunder. The Sublicense Agreement
will include the following provisions of this Agreement:
Article 4 - Royalty Reports; Records; Article 7 -
Indemnification and Insurance; and, Article 8 - Disclaimer of
Warranties; and, Section 10.12 - References to BECKMAN; and
further will provide that those provisions are for the benefit of
and may be enforced by BECKMAN. EXACT will provide BECKMAN with a
copy of the Sublicense Agreement within sixty (60) days after it is
executed.
2.4
NO IMPLIED LICENSES. Nothing in this
Agreement shall be construed as granting any Party any right or
license under any Intellectual Property of the other Party by
implication, estoppel or otherwise, except as expressly provided
otherwise in this Agreement.
2.5
EXCLUDED FIELD. Notwithstanding
anything to the contrary in this Agreement, the licenses granted
therein shall not extend to /*/[CONFIDENTIAL TREATMENT
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REQUESTED]/*/ or to /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/ provided that the foregoing limitation
shall (i) only be in force during the shorter of the term of
the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ specified in the
definitions thereof, or during such time as such /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/ are valid, enforceable and maintained and
(ii) not limit or restrict EXACT’s right to use the
Licensed Patents in connection with /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ and /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ to the
extent EXACT has obtained license rights to /*/[CONFIDENTIAL
TREATMENT REQUESTED]/*/ and /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ from an appropriate Third Party.
ARTICLE 3 - ROYALTIES
3.1
ROYALTIES. During the License Term,
EXACT shall pay BECKMAN a /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/
percent /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ royalty on EXACT
Net Revenues. EXACT shall pay royalties due with respect to each
calendar quarter hereunder within forty-five (45) days after the
last day of such calendar quarter.
ARTICLE 4 - ROYALTY REPORTS; RECORDS
4.1
ROYALTY REPORTS. Within forty-five
(45) days after March 31, June 30, September 30 and
December 31 of each year during the Term, EXACT shall deliver
to BECKMAN the royalty payment due pursuant to Section 3.1
hereof and a corresponding royalty report relating to the calendar
quarter to which the royalty paid relates. If EXACT Net Revenue
includes revenue denominated in a currency other than the currency
of the United States of America, those foreign currency sales for
each calendar quarter will be converted to the currency of the
United States of America at the prevailing rate for the last
business day of the quarter as quoted by THE WALL STREET JOURNAL
(or if THE WALL STREET JOURNAL is not available
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then a comparable publication) or
such conversion shall be accomplished by a procedure mutually
agreed upon by EXACT and BECKMAN.
4.2
REPORTS. Each royalty report shall
include the following:
(a)
Identification of the Licensed
Services performed by EXACT during the relevant calendar
quarter;
(b)
The quantity of each Licensed
Services performed by EXACT during the relevant calendar
quarter;
(c)
The Exact Net Revenues for each of
the Licensed Services performed by EXACT during the relevant
calendar quarter;
(d)
Deductions applicable to determining
EXACT Net Revenues during the relevant calendar quarter;
(e)
Identification of the Licensed
Services performed by Sublicensee during the relevant calendar
quarter;
(f)
The quantity of each Licensed
Services performed by Sublicensee during the relevant calendar
quarter;
(g)
The Exact Net Revenues for each of
the Licensed Services performed by Sublicensee during the relevant
calendar quarter;
(h)
Total royalties due to EXACT from
Sublicensee under the sublicense granted under this Agreement
during the relevant calendar quarter; and
(i)
Total royalties due to BECKMAN for
the calendar quarter.
With each report, EXACT shall pay to
BECKMAN the royalties due and payable for such calendar quarter in
accordance with paragraph 3.1.
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4.3
RECORD KEEPING.
4.3.1
BOOKS AND RECORDS. EXACT shall keep
complete and accurate records for the latest five (5) years as
necessary to establish from source documents and data the EXACT Net
Revenues for each Licensed Service. EXACT will maintain such
records in sufficient detail and in a manner and context to enable
the determination of the amount of royalties due hereunder to
BECKMAN.
4.3.2
INSPECTIONS. Upon thirty (30)
days’ written notice, EXACT agrees to permit one or more
auditors appointed by BECKMAN (except any to whom EXACT has a
reasonable objection) to enter upon the premises of EXACT during
usual business hours of EXACT in order to examine records
pertaining to this Agreement for previous quarter(s) and to
make on EXACT’s premises and retain copies of any and all
parts of the records and accounts kept by EXACT pursuant to this
Article 4, including invoices and Sublicense payment records
and reports which are relevant to any report required to be
rendered by EXACT. Said copies shall be provided to the
auditor(s) at no expense to the auditor(s) or to BECKMAN.
Said auditor(s) shall provide BECKMAN with the amount of the
EXACT Net Revenue and the application of the appropriate royalty
rate so that royalties due BECKMAN may be calculated for each
Licensed Service. In the event such audit establishes that EXACT
has underpaid its royalty obligations by /*/[CONFIDENTIAL TREATMENT
REQUESTED]/*/ or more during any calendar quarter, any amounts
found to have been owed but not paid shall be paid to BECKMAN
promptly with nine percent (9%) interest per annum. In the event
such audit establishes that EXACT has underpaid its royalty
obligations by /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or more
during any calendar quarter, EXACT shall reimburse BECKMAN for the
out-of-pocket expense of such audit. BECKMAN shall not make more
than one audit request annually.
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4.4
FORM OF PAYMENTS. EXACT shall
make all payments due under this Agreement by check or wire
transfer in United States funds.
4.5
LATE PAYMENT. If EXACT does not make
any payment under this Agreement when due, the payment will
accrue