Exhibit 10.8
*** Confidential
Treatment Requested. Confidential portions of this document have
been redacted and have been separately filed with the
Commission.
PCR
Patent License Agreement
BY AND BETWEEN
Roche Molecular Systems, Inc.
AND
Genomic Health, Inc.
PATENT LICENSE
AGREEMENT
(HUMAN)
CONTENTS
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Background
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Section 1
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Definitions |
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Section 2
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Grant |
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Section 3
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Additional Limitations &
Acknowledgment re Diagnostic Products |
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Section 4
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Royalties, Records and Reports |
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Section 5
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Technology Notification |
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Section 6
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Diligence |
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Section 7
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Term and Termination |
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Section 8
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Confidentiality-Publicity |
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Section 9
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Compliance |
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Section 10
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Assignment |
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Section 11
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Negation of Warranties and
Indemnity |
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Section 12
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General |
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Attachments:
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Attachment I
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List of Licensed Technology |
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Attachment II
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Combination Services |
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Attachment III
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Summary Royalty Report Form |
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Attachment IV
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Collection Rate |
1
PATENT LICENSE
AGREEMENT
. (Human)
This Agreement is made by
and between
Roche Molecular Systems,
Inc., 4300 Hacienda Drive, Pleasanton, California 94588
(hereafter referred to
as “RMS”)
and
Genomic Health, Inc., 301
Penobscot Drive, Redwood City, California 94604
(hereafter referred to
as “GH”)
hereafter individually
referred
to as a
“Party” or collectively as “The
Parties”
********
BACKGROUND
| A. |
RMS owns and has the right to grant licenses to practice under
certain United States Patents describing and claiming, inter
alia, nucleic acid amplification processes known as polymerase
chain reaction (“PCR”), homogeneous PCR, and RT-PCR
(“reverse transcription PCR”). |
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| B. |
GH desires to obtain a non-exclusive license from RMS to use
the Licensed Technology to perform certain PCR-based human in
vitro clinical laboratory services, and RMS is willing to grant
such a license to GH on the terms and subject to the conditions
provided exclusively in this Agreement. |
NOW, THEREFORE, for and in
consideration of the mutual covenants contained herein, RMS and GH
agree as follows:
For the purpose of this
Agreement, and solely for that purpose, the terms set forth
hereinafter shall be defined as follows:
| 1.1 |
The term “Affiliate” shall mean with respect
to a given Party: |
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a) |
an organization which, directly or indirectly, controls such
Party; |
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b) |
an organization which is, directly or indirectly, controlled by
such Party; or |
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c) |
an organization which is controlled, directly or indirectly, by
the ultimate parent company which controls, directly or indirectly,
such Party. |
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For purposes of this paragraph, “control” shall
mean the ownership of fifty percent (50%) or more of the voting
stock or equity interests of an organization or otherwise having
the power to govern or direct the financial and the operating
policies or to appoint the management of such organization. |
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With respect to RMS, the term “Affiliate” shall not
include Genentech, Inc., 1 DNA Way, South San Francisco, California
94080-4990, U.S.A. (“Genentech”) nor Chugai
Pharmaceutical Co., Ltd, 1-9, Kyobashi 2-chome, Chuo-ku, Tokyo,
104-8301 Japan (“Chugai”). |
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| 1.2 |
“Combination Service” shall mean a Licensed
Service offered in combination with another non-PCR testing service
or together with a non-testing service(s) such as a specialized
interpretive service or a consultative service (e.g., genetic
counseling) as part of a package, where the Licensed Service is not
separately billed. |
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| 1.3 |
“Diagnostic Product” shall mean an
assemblage of reagents, including but not limited to reagents
packaged in the form of a kit, useful in performing a Licensed
Service. |
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| 1.4 |
“Effective Date” shall mean the date on
which the last signatory to this Agreement signs this
Agreement. |
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| 1.5 |
“Licensed Field” shall mean the field of
clinical laboratory services that detect the presence, absence
and/or quantity of a nucleic acid sequence for the detection,
diagnosis, confirmation, prognosis, management and/or treatment of
a human disease or condition, including, but not limited to, such
services: to identify predisposition to disease, disease
susceptibility, confirm disease, predict therapeutic effectiveness
or monitor disease progress; used in the course of human clinical
trials; for Parentage Determination; and for tissue transplant
typing, including testing performed on animal tissue intended for
use in xenotransplantation. Licensed Field shall specifically
exclude any services performed for the screening of blood and/or
blood products. |
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| 1.6 |
“Licensed Service(s)” shall mean the
performance by GH of an in vitro procedure within the
Licensed Field which utilizes the Licensed Technology. Licensed
Services include, but are not limited to, any combination of the
steps of collecting a sample for analysis, isolating nucleic acid
sequences from the sample, amplifying one or more desired
sequences, analyzing the amplified material, including sequence
analysis, and reporting the results. |
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| 1.7 |
“Licensed Technology” shall mean, subject to
the following limitations, the Valid Claims of the United States
patents listed in Attachment I to this Agreement and any reissue or
reexamination patents thereof. No rights under any kit claims of
such patents are included in this definition or licensed under this
Agreement. With the exception of the reaction mixture claims of
United States Patents Nos. 5,804,375, 5,693,517, 5,476,774 and
6,127,155, the plasmid claims of the 5,476,774 patent, the primer
claims of United States Patent No. 5,573,906, and the probe claims
of United States Patent No. 5,110,920, no rights under any
apparatus, device, composition of matter, reagent or substance
claims of such patents are included in this definition or licensed
under this Agreement. |
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| 1.8 |
“Net Service Revenues” shall mean the gross
invoice price for the Licensed Services performed by GH (or the
fair market value for any nonmonetary consideration which GH agrees
to receive in exchange for Licensed Services), less the following
deductions where they are factually applicable and are not already
reflected in the gross invoice price: |
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a) |
discounts allowed and taken, in amounts customary in the trade
(which shall include the difference between the dollar amount
charged by GH for a Licensed Service and the Medicare and/or
Medicaid Limits of Allowance and/or reimbursement limitations of a
Third Party insurance program); and |
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b) |
actual bad debt which bad debt GH can prove and document that
it was reasonable and diligent in its efforts to collect
payment. |
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1.8.1 |
The Net Service Revenues of those Licensed Services that are
performed by GH for any person, firm or corporation controlling,
controlled by or under common control with GH, or enjoying a
special course of dealing with GH, shall be determined based on the
average selling price of such Licensed Services to all Third
Parties during the period in question. |
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1.8.2 |
It is hereby understood and agreed that, to the extent
feasible, Licensed Services and Combination Services shall at all
times be invoiced, listed and billed by GH as . a separate item
in GH’s invoices, bills and reports to customers. Net Service
Revenues for determining royalties with respect to a Licensed
Service which is part of a Combination Service shall be determined
by multiplying the gross invoice price of the Combination Service,
less applicable deductions, by the appropriate fraction in
Attachment II hereto. The fraction specified in Attachment II for a
particular Licensed Service included in a Combination Service shall
be set by RMS after consultation |
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with GH, as accurately reflecting the value contributed by the
Licensed Service to the overall value of the Combination Service as
offered by GH, and as provided in Section 2.4. Attachment II
hereto shall be modified as new Combination Services are identified
and new royalty-bearing fractions set, and as set forth in
Section 2.4. |
| 1.9 |
“Parentage Determination” shall mean
analysis of human genetic material to ascertain whether two or more
individuals are biologically related, but specifically excludes
analysis of forensic evidence for a sexual assault
investigation. |
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| 1.10 |
“Territory” shall mean the United States and
its possessions and the Commonwealth of Puerto Rico. |
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| 1.11 |
“Third Party” shall mean an entity other
than an Affiliate of either Party to this Agreement. |
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| 1.12 |
" Valid Claim ” shall mean a claim of a patent
which has not expired or been disclaimed, cancelled, held invalid
or held unenforceable by a decision of a court or other
governmental agency of competent jurisdiction, from which no
further appeal is possible or has been taken within the time period
provided under applicable law for such an appeal. |
| 2. |
Grant |
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| 2.1 |
Grant . Upon the terms and subject to the conditions and
restrictions of this Agreement, RMS hereby grants to GH, and GH
hereby accepts from RMS, a royalty-bearing, non-exclusive,
personal, non-transferable license under the Licensed Technology
solely to perform Licensed Services within the Territory. |
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| 2.2 |
Performance of Licensed Services Only . The Licensed
Technology may be used solely for the performance of Licensed
Services and for no other purpose whatsoever, and no other right,
immunity or license is granted to GH expressly, impliedly or by
estoppel. |
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| 2.3 |
Personal License . GH expressly acknowledges and agrees
that the license granted hereunder is personal to GH alone and GH
shall have no right to sublicense, assign or otherwise transfer or
share its rights under the foregoing license. |
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| 2.4 |
Combination Service(s) . For each Combination Service
that GH intends to offer pursuant to this Agreement, and at least
sixty (60) days before GH intends to offer any such
Combination Service, GH shall: |
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a) |
notify RMS of such proposed Combination Service, such notice to
include a complete and detailed description of the proposed
Combination Service; and |
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b) |
obtain from RMS a duly authorized agreement, in the form of
Attachment II hereto, for such Combination Service, which agreement
shall indicate the fraction or |
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*** Confidential
material redacted and filed separately with the Commission.
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percentage of the package price of such Combination Service,
less appropriate deductions, on which royalties shall be paid
hereunder. |
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For any Combination Service(s) for which GH has not satisfied
the criteria set forth in subsections (a) and (b) above,
the royalty payable on such Combination Service shall be assessed
on 100% of the package price of such Combination Service, less
applicable deductions. As to all other Licensed Services offered by
GH which are not part of a Combination Service, GH agrees to inform
RMS of the availability from GH of each such Licensed Service
within thirty (30) days after GH commences offering the
Licensed Service. |
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| 2.5 |
Credit for Licensed Technology Rights . RMS hereby
grants to GH the right and GH accepts and agrees to credit RMS as
the source of its Licensed Technology rights in GH’s
promotional materials and any other materials intended for
distribution to Third Parties as follows: |
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“This service is performed pursuant to an agreement with
Roche Molecular Systems, Inc.” |
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| 3. |
Additional Limitations and Acknowledgment Regarding
Diagnostic Products |
GH acknowledges and agrees
that the license rights granted hereunder are for the performance
of Licensed Services only and do not include any right to make,
have made, import, offer to sell or sell any products, including
apparatuses, devices, PCR reagents, kits or Diagnostic Products. GH
further acknowledges and agrees that RMS and its Affiliates are in
the business of providing clinical laboratory testing services and
the commercial sale of diagnostic testing systems, kits and
reagents and therefore may compete directly with GH’s
business.
| 4. |
Royalties, Records and Reports |
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| 4.1 |
Royalties . For the rights and privileges granted under
Section 2.1 of this Agreement, GH shall pay to RMS royalties
equal to *** percent (***%) of GH’s Net Service
Revenues. |
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No royalty is due on PCR-based assays performed solely for the
purpose of evaluating a procedure to be used as a Licensed Service
after validation. |
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No royalty is due on assays performed with Roche labeled
diagnostic kits or Third Party diagnostics kits licensed by Roche,
which convey human diagnostic label license rights to end
users. |
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| 4.2 |
Reports . GH shall deliver to RMS, within forty-five
(45) days after the end of and for each quarterly calendar
period during the Term, i.e. the three (3) month periods that
are January 1 through March 31, April 1 through June 30,
July 1 through September 30, and October 1 through
December 31 (each a “Reporting Period”), a true
and accurate royalty report (“Royalty Report”). Each
Royalty Report shall indicate the number of Licensed Services
performed during the relevant Reporting Period and the detail
specified on the “Summary |
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Royalty Report,” a copy of which is attached hereto as
Attachment III, or on a form generated by GH which duplicates the
format of the Summary Royalty Report. If no royalties are due for a
given Royalty Period, it shall be so reported. The correctness and
completeness of each Royalty Report shall be attested to in writing
by an authorized representative of GH. |
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In the event GH is unable to calculate Net Service Revenues as
prescribed in Section 1.8, GH shall so inform RMS, and upon
RMS’s written consent, GH shall calculate royalties as
follows: |
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Upon receipt by RMS of satisfactory documentation verifying
GH’s actual percentage of gross billings for Licensed
Services and/or Combination Services collected for GH’s most
recently ended fiscal year (the “Collection Rate”),
subject to the provisions of Section 2.4 above, GH shall be
permitted to calculate Net Service Revenues taking into account the
Collection Rate. As of the Effective Date, GH hereby represents and
confirms to RMS that its Collection Rate for its fiscal year ending
NA was NA percent ( NA %), which rate is
specified in Attachment IV. During the Term of this Agreement, and
within ninety (90) days after the end of each GH fiscal year, GH
shall deliver to RMS satisfactory documentation tha |
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