Exhibit 10.1
LICENSE AGREEMENT
Case Western Reserve University
– Exact Sciences Corporation
This Agreement (hereinafter
“this Agreement”) entered into as of this 18th day of
July, 2005 (“Effective Date”) by and between Case
Western Reserve University, an Ohio non-profit corporation, having
a principal place of business at 10900 Euclid Avenue, Cleveland,
Ohio 44106 (“CASE”) and Exact Sciences Corporation, a
Delaware corporation, having a principal place of business at 100
Campus Drive, Marlborough, MA 01752
(“Licensee”).
WITNESSETH
WHEREAS, CASE has, subject to
certain interests of Howard Hughes Medical Institute
(“HHMI”), certain technology developed in the
laboratory of Dr. Sanford Markowitz, a Howard Hughes Medical
Institute Investigator at CASE, relating to HLTF and Vimentin Gene
Methylation in Colon Cancer, and is interested in licensing
same,
WHEREAS, CASE has right, by reason
of its Intellectual Property Policy and assignment from HHMI, to
license such technology, subject to the right of HHMI to review and
approve of any such license;
WHEREAS, CASE’s interest in
such technology is subject to certain retained rights by the United
States of America and HHMI;
WHEREAS, Licensee desires to acquire
rights in and to the technology upon the terms and conditions
herein set forth;
NOW THEREFORE, in consideration of
the mutual covenants contained herein and intending to be legally
bound hereby, the parties agree as follows:
1.
DEFINITIONS
1.1
The term
“Copyrights” shall mean CASE’s and/or
HHMI’s copyrights in the Licensed Technology.
1.2
The term
“Dispose” or “Disposition” shall mean the
sale, lease or other transfer of Licensed Product(s).
1.3
The term
“Dollar”, “U.S. Dollar” and “U.S.
$” shall mean lawful money of the United States of
America.
1.4
The term
“Field of Use” shall mean use of the Licensed
Technology in detecting human colorectal cancer and tumors,
including, without limitation, adenomas, in stool-based assays, and
other products for the purposes of colorectal disease screening and
detection, disease staging, disease monitoring, disease prognosis,
and/or pharmacogenomic testing.
1.5
The term
“Fiscal Quarter” or “Quarter” shall refer
to the normal quarterly accounting periods of Licensee; if Licensee
does not have normal quarterly accounting periods,
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.
then “Fiscal
Quarters” shall mean the calendar three months periods
commencing with January of each year.
1.6
The term
“Licensed Product” shall mean any product, service
and/or process that constitutes, is based on, incorporates or uses,
in whole or in part, Licensed Technology, including any mutant or
altered form of the genetic material which is covered by the Patent
Rights.
1.6.1
The term
“Licensed Combination Product” shall mean a Licensed
Product that includes one or more genes for which Licensee or a
Product Sublicensee must pay royalties, upon Disposition, to one or
more Third Party Licensors.
1.6.2
The term
“Third Party Licensor” means an entity (other than
CASE, Licensee or Sublicensee) that has entered a royalty-bearing
license agreement with Licensee or a Product Sublicensee for one or
more genes included in a Licensed Product.
1.7
The term
“Licensed Technology” or “Technology” shall
mean (i) the Patent Rights ; and (ii) the technology,
trade secrets, know-how, improvements and other information and
intellectual property of CASE identified in Attachment
A.
1.8
The term
“Licensee Net Sales” shall mean the total of [********]
received by Licensee due to Dispositions of Licensed Products
(other than Dispositions by Product Sublicensees), less the total
of all:
[********]
No deduction shall be made for
commissions paid to individuals whether they are individual sales
agents or persons regularly employed by Licensee.
1.9
The term
“Product Sublicensee Royalty Basis” shall mean the
revenue or sales total used in a sublicense agreement between
Licensee and a Product Sublicensee as the basis for computing
royalties owed by such Product Sublicensee to Licensee due to
Dispositions of Licensed Products. Product Sublicensee
Royalty Basis, however, shall be no less than the value of Licensee
Net Sales that would result from considering Revenues of Product
Sublicensee to be Revenues of Licensee, unless CASE has agreed in
advance to accept a particular definition of “Product
Sublicensee Royalty Basis” for the computation of Royalties
due to Dispositions by a Product Sublicensee.
1.10
The term
“Patent Rights “ shall mean and include the United
States patents and/or patent applications listed in Attachment A to
this Agreement; United States patents issued from the applications
listed in Attachment A and from divisionals and continuations of
these applications and any reissues of such United States patents;
claims of continuation-in-part applications and patents directed to
subject matter specifically described in the applications described
above; and claims of all foreign patent applications, patents, and
other intellectual property which are directed to subject matter
specifically described in the United States patents and/or patent
applications described above.
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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1.11
The term
“Prime Rate” shall mean the interest rate per annum
announced from time to time by Key Bank, Cleveland, Ohio, as its
prime rate.
1.12
The term
“Product Launch” shall mean the first commercial sale
of Licensed Product(s).
1.13
The term
“Product Sublicensee” shall mean an entity to which
Licensee sublicenses rights to make, sell, distribute, manufacture,
or otherwise convey or Dispose of Licensed Products pursuant to a
sublicense agreement.
1.14
The term
“Revenue” shall mean the U.S. Dollar value of all
consideration realized from the Disposition of Licensed
Product(s).
1.15
The term
“Royalties” shall mean royalties calculated as a
percentage of Net Sales and payable by Licensee to CASE under this
Agreement.
1.16
The term
“Year” refers to contract years of the License
Agreement, i.e ., a 12-month period starting with the date
(or anniversary) of the Effective Date of the License
Agreement.
2.
LICENSE
GRANT
2.1
CASE hereby
grants to Licensee, and Licensee hereby accepts, (i) an
exclusive, royalty bearing, world-wide right and license under and
to the Licensed Technology to make, have made, use and Dispose of
Licensed Products in the Field of Use and (ii) a
non-exclusive, world-wide, royalty free right and license under and
to the Licensed Technology for internal research and development
purposes in the Field of Use.
2.2
No right to
sublicense the Licensed Technology is hereby granted to Licensee
except that Licensee may sublicense to (i) Product
Sublicensees to the extent necessary to enable Product Sublicensees
to make and/or Dispose of Licensed Products within the Field of
Use; (ii) customers to the extent necessary for their personal
use of a Licensed Product; or (iii) other entities with the
specific agreement of CASE.
2.2.1
Licensee
understands that any sublicenses granted by Licensee to entities
other than customers (even though the specific agreement by CASE to
such a sublicense has been obtained) must provide that the
obligations to CASE and HHMI (as a third-party beneficiary) under
this Agreement, including but not limited to, Indemnification,
Insurance, HHMI’s third party beneficiary status, and
procedures for Dispute Resolution shall be binding upon such
sublicensee as if it were a party to this Agreement and that the
economic return to CASE from the Disposition of Licensed Products
be not less than the economic returns would be if such Disposition
had been by Licensee. In addition, any sublicense agreement
shall provide for automatic assignment to CASE in the event of
termination of Licensee’s license to the Licensed Technology
(prior to expiration of this Agreement). Licensee shall be
responsible for the acts or omissions of its sublicensees and shall
not grant any rights which are inconsistent with the rights granted
to and obligations of Licensee hereunder. Any act or omission
of a sublicensee that would be a breach of this License Agreement
if performed by Licensee 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.
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deemed to be a breach of
this License Agreement by Licensee if such breach is not cured
before 180 days. Each sublicense agreement granted by
Licensee shall include an audit right by CASE of the same scope as
provided herein below with respect to Licensee. No such
sublicense agreement shall contain any provision which would cause
it to extend beyond the Team of this Agreement. Licensee
shall give CASE prompt notification of the identity and address of
each sublicensee with whom it concludes a sublicense agreement and
shall supply CASE with a copy of each such sublicense
agreement.
2.3
No provision of
this Agreement shall restrict Licensee’s, CASE’s and/or
HHMI’s ability to conduct further research and development in
the area of Licensed Technology or other areas.
2.4
All Licensed
Products shall be manufactured, sold and performed by Licensee in
compliance with all applicable governmental laws, rules and
regulations. Licensee shall keep CASE fully informed of, and
shall move expeditiously to resolve, any complaint by a
governmental body relevant to Licensed Products, except for
complaints subject to the Section of this Agreement entitled
“Infringement.”
2.5
CASE represents
and warrants that CASE has the right to license the Patent Rights
to Licensee under the terms provided in this Agreement and that
CASE’s obligations to HHMI do not conflict with the licenses
provided hereunder. CASE retains the right to grant either
exclusive or non-exclusive licenses for the Licensed Technology in
fields of use other than the Field of Use for which the license
hereunder is granted.
2.6
If Licensed
Technology was supported under a United States Government funding
agreement, then (a) the United States Government has been or
will be granted licensing rights solely as required under the terms
of those federal agreements, (b) all rights and obligations
reserved to the United States Government and others under Public
Law 96-517, and Public Law 98-620 and any applicable governmental
rules and regulations, including but not limited to government
purpose license and march-in rights and sharing of certain research
materials, shall be respected and shall in no way be diminished by
this Agreement and any right granted in this Agreement regarding
Licensed Technology greater than that permitted under Public Law
96-517 or Public Law 98-620, and any applicable governmental
rules and regulations, shall be subject to modification as may
be required to conform to the provisions of those statutes, and
(c) products using Licensed Technology sold or used in the
United States will be manufactured substantially in the United
States of America, unless a waiver has been obtained from the
federal funding agency under whose funding agreement the Licensed
Technology was generated.
2.7
Notwithstanding
the license granted in this Agreement, CASE and HHMI and any health
care institutions affiliated with either of them shall have and
retain all rights to use, free of charge, the Licensed Technology
for their non-commercial research, clinical research treatment (
i.e. the treatment of patients as part of a clinical
research effort to determine the effectiveness, safety or
tolerability of Licensed Technology), educational or academic
purposes, even in the Field of Use, but not for licensing to
others. There is no restriction on licensing by CASE of
Licensed Technology outside the Field of Use.
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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2.8
CASE and HHMI may
have in the past, and shall have the right in the future, to
provide Licensed Technology to academic and/or non-profit health
care institutions for non-commercial research, clinical research
treatment, educational, or academic purposes. Nothing in this
Agreement shall prohibit such conduct by CASE or HHMI or use for
such purposes by academic or non-profit health care institutions
receiving Licensed Technology from CASE or HHMI. For the
avoidance of confusion, CASE may not, during the Term of this
Agreement, permit any third party to use the Licensed Technology in
the Field of Use for commercial purposes.
3.
FIELD OF USE
OPTION
CASE hereby grants to Licensee an
option (the “Field of Use Option”) for a term of
twenty-four (24) months only, commencing on the Effective Date,
(the “Option Period”) to negotiate an amendment to the
Agreement with CASE to expand the Field of Use for the Licensed
Technology to include human blood-based assays for the purposes of
colorectal disease screening and detection, disease staging,
disease monitoring, disease prognosis, and/or pharmacogenomic
testing. To exercise this Field of Use Option, Licensee must
(i) provide a written statement, reasonably satisfactory to
CASE, demonstrating Licensee’s capability and intention to
develop Licensed Products within the human blood-based assay field
of use for public sale as soon as practicable, consistent with
sound and reasonable business practices and judgment, and
(ii) execute an amendment to this Agreement with CASE prior to
expiration of the Option Period.
4.
TERM OF THIS
AGREEMENT
This Agreement shall expire at the
end of its term (the “Term”), which extends from the
Effective Date to the expiration of the last to expire of the
Patent Rights. The Agreement may be terminated prior to
expiration pursuant to other provisions of this
Agreement.
5.
DUE
DILIGENCE
5.1
Licensee shall
use its best commercially reasonable efforts to effect introduction
of Licensed Technology into the commercial market as soon as
reasonably practical; thereafter, until the termination of this
Agreement, Licensee shall keep Licensed Technology reasonably
available to the public. At a minimum, Licensee shall achieve
Product Launch within thirty (30) months of the Effective
Date.
5.2
Licensee’s
default in performance in accordance with Subsection 5.1 shall be
grounds for CASE to terminate this Agreement.
6.
LICENSE FEES AND
ROYALTIES
6.1
For Dispositions
of Licensed Products other than Licensed Combination Products,
Licensee shall pay CASE a Royalty of [********] (hereinafter the
“Royalty Rate”) of the sum of Licensee Net Sales and
Product Sublicensee Royalty Basis.
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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6.2
For Dispositions
of Licensed Combination Products, the Royalty Rate of [********]
shall be reduced by the percentage, if any, of Licensee Net Sales
and/or Product Sublicensee Royalty Basis payable as a royalty to
the Third Party Licensor(s) who have contributed one or more
genes to such Licensed Combined Products. Notwithstanding the
foregoing, in no event shall the Royalty Rate be less than 1
percent.
6.3
The parties
acknowledge that Licensee, in partial satisfaction of its fee
obligations to CASE hereunder, paid CASE [********] on
March 10, 2003. In addition to this amount, Licensee
shall pay CASE non-refundable License Fees of (i) [********]
due and payable [********]; (ii) [********] due and payable,
if this Agreement is still in effect, upon the earlier of:
(a) [********] or, (b) [********]; and
(iii) [********] due and payable [********]. The License
Fees described in this section 6.3 will be in addition to any other
amounts due under this Agreement.
6.4
Licensee shall
pay CASE a minimum royalty of [********] per year (“
Annual Minimum Royalty ”), commencing on the
anniversary date of the Effective Date following the Product
Launch, and payable on each anniversary of the Effective Date
thereafter. The Annual Minimum Royalty shall be credited
against the Royalties payable in a Year.
6.5
Annual Minimum
Royalty payments are to be adjusted by the cumulative percentage
change in the CPI-W Consumer Price Index between December 2004
and the December preceding the date on which the payment in
question is payable.
7.
PAYMENT
TERMS
7.1
Royalties shall
be paid by Licensee to CASE, as defined in the
Section entitled “Royalties” for each Fiscal
Quarter within sixty (60) days of the end of such Fiscal Quarter,
until this Agreement expires or is terminated in accordance with
this Agreement. If this Agreement terminates before the end
of a Fiscal Quarter, the payment for that terminal fractional
portion of a Fiscal Quarter shall be made within ninety (90) days
of the date of termination of this Agreement.
7.2
All Royalties
hereunder shall be paid in U.S. Dollars and shall be made by wire
transfer to CASE’s account No. [********] at Key
Bank’s Cleveland office, or by Licensee’s check sent in
accordance with the Section entitled
“Notices”.
7.3
All Royalties
payable hereunder that are overdue shall bear interest until paid
at a rate equal to the Prime Rate in effect at the date such
Royalties were due plus four percent (4%) per annum, but in no
event to exceed the maximum rate of interest permitted by
applicable law. This provision for interest shall not be
construed as a waiver of any rights CASE has as a result of
Licensee’s failure to make timely payment of any
amounts.
8.
REPORTS AND
AUDITS
8.1
Licensee shall
provide Quarterly reports of its progress in achieving Product
Launch and shall notify CASE within ten (10) days of achieving
Product Launch.
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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8.2
Licensee shall
maintain accurate books and records such that the Royalties due and
payable hereunder can be easily ascertained. Such books and
records shall be maintained at Licensee’s principal place of
business and shall be available for inspection by CASE or its
representatives during the normal business day upon not less than
ten (10) days prior written notice, provided that CASE or its
representatives agree to protect the confidentiality of the
informational Licensee.
8.3
Licensee shall
make available Licensee’s books and records for audit by an
independent accounting firm of CASE’s selection and Licensee
agrees to cooperate fully in any such audit, provided that the
auditors agree to protect the confidentiality of the information of
Licensee. Any such audit shall not be more frequent than
annually. In the event that such audit determines that the
amount of Royalties paid to CASE was in error by the greater of
[********] or [********], Licensee shall pay the costs of the
audit.
9.
IMPROVEMENTS
9.1
Discussion of
technical matters with each other by the parties will not create in
a party any rights to ownership of patents, copyrights, trade
secrets or other intellectual property rights in solutions to the
matters that are invented solely by employees or agents of the
other party hereto.
9.2
Licensee will own
all of the right, title and interest (including patents,
copyrights, trade secrets and any other intellectual property
rights) in and to any results developed solely by Licensee or on
its behalf in connection with this Agreement, including the results
of any collaboration between the parties that are invented solely
by Licensee’s employees or agents.
9.3
CASE will own all
of the right, title and interest (including patents, Patent Rights,
Copyrights, mask work rights, trade secrets and any other
intellectual property rights) in and to any results developed
solely by CASE or on its behalf in connection with this Agreement,
including the results of any collaboration between the parties that
are invented solely by CASE employees or agents.
9.4
All intellectual
property that is a direct improvement of and is
dominated
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