Exhibit 10.6.1
*** Confidential
Treatment Requested. Confidential portions of this document have
been
redacted and have been separately filed with the
Commission.
PATENT LICENSE
AGREEMENT
THIS LICENSE AGREEMENT,
dated as of March 30, 2001, is entered into between INCYTE
GENOMICS, a Delaware corporation, with offices at 3160 Porter
Drive, Palo Alto, California 94303 (“Incyte”), and
Genomic Health, Inc., a Delaware corporation with offices at 101
University Avenue, Suite 220, Palo Alto, California 94301
(“GHI”).
BACKGROUND
WHEREAS, Incyte has the right to
grant licenses under certain patent applications and patents that
have application to Diagnostic Products (as defined herein) and
Personalized Research Products (as defined herein).
WHEREAS, GHI is interested in
obtaining, and Incyte has agreed to grant licenses under certain of
these patents and patent applications for use in the fields
described herein, subject to the terms and conditions of this
Agreement.
NOW THEREFORE, in consideration of
the foregoing premises and the mutual covenants herein contained,
the parties hereby agree as follows:
ARTICLE
1
DEFINITIONS
In this Agreement the
following words and expressions have the following meanings:
| 1.1 |
“ Affiliate ”: shall mean any corporation or
other entity that is directly or indirectly controlled by GHI. For
the purpose of this agreement, control means ownership of one
hundred percent (100%), or in the case of foreign corporations or
entities the greatest percentage that may be owned by foreign
interests, of the shares or other equity interests entitled to vote
for the election of directors, in the case of a corporation, or
equivalent governing body in the case of any other entity. |
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| 1.2 |
“ Calendar Quarter ”: shall mean a period of
three consecutive calendar months ending on March 31,
June 30, September 30 or December 31. |
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| 1.3 |
“ Cancer Marker Patent Rights ”: shall mean
all claims listed in any of the following patents and patent
applications, to the extent that they are owned by Incyte with the
right to license under this Agreement, and to the extent that they
claim the composition of matter or use of any nucleic acids or
proteins as markers or diagnostics for cancer: (a) the patents
and patent applications listed in Schedule A to this
Agreement, and (b) all counterpart foreign patent applications
claiming priority of the patents and patent applications described
in clause (a) above, together with all continuations,
continuations-in-part and divisions of such patents and patent
applications, (c) all patents issuing from any patent |
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application described in clause (a) or (b) above, and
(d) all reissues and re-examinations of any of the foregoing
patents. |
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| 1.4 |
“ Control ” or “ Controlled
” shall mean possession of the ability to grant the right and
licenses provided for herein, without violating the terms of any
agreement or other arrangement with any third party, and which a
party has the right to disclose or provide to the other party
without a resulting obligation to pay royalties or other amounts to
a third party. |
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| 1.5 |
“ Database Patent ”: shall mean (a) the
patents listed in Schedule D to this Agreement, and
(b) all counterpart foreign patent applications claiming
priority of the patents and patent applications described in clause
(a) above, together with all continuations,
continuations-in-part and divisions of such patents and patent
applications, (c) all patents issuing from any patent
application described in clause (a) or (b) above, and
(d) all reissues and re-examinations of any of the foregoing
patents. |
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| 1.6 |
“ Diagnostic Field of Use ”: shall mean the
research, development, manufacture, importation. use and/or sale of
Diagnostic Product(s). The Diagnostic Field of Use excludes the
Personalized Research Field of Use, the Homebrew Field of Use and
the Internal Research Field of Use. |
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| 1.7 |
“ Diagnostic Product(s) ”: shall mean an
assay provided as a product or service performed on a human tissue
or other human biological sample containing nucleic acids or
proteins that are collectively intended to establish or identify an
association between the presence or absence of such nucleic acids
or proteins and: |
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(i) |
diagnosis of the presence of, or absence of, a specific
disease(s), state(s) or condition(s) in humans; |
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(ii) |
predisposition to the presence of, or absence of, a specific
disease(s), state(s) or condition(s) in humans; |
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(iii) |
response or lack of response to disease therapy(ies) in humans
or preventative strategies in humans; |
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(iv) |
prediction of the disease course in humans, and or other
changes in state(s) or condition(s) in humans over time; |
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(v) |
clinical traits in humans for which a medical professional
should be consulted; |
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(vi) |
variation(s) in specific trait(s) and/or characteristics among
individuals; and/or |
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(vii) |
predisposition to development of toxicities to disease
therapies or preventative strategies in humans, |
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the results of which are provided to payors, providers or
patients, and for which FDA approval (or comparable regulatory
agency in other jurisdictions) is required. Diagnostic Products
exclude Homebrew Products, Personalized Research Products and GHI
Database Products. |
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| 1.8 |
“Effective Date” : shall mean the date first
set forth above. |
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| 1.9 |
“ GHI Database Field of Use ”: shall mean
the research, development, manufacture, importation, use and/or
sale of GHI Database Product(s) to end users. |
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| 1.10 |
“ GHI Database Product ”: GHI Database
Product shall mean a collection of information derived from or by
testing a person or persons in the Diagnostic Field of Use,
Homebrew Field of Use or the Personalized Research Field of Use.
GHI Database Products exclude Diagnostic Products, Homebrew
Products, and Personalized Research Products. |
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| 1.11 |
“ Homebrew Field of Use ”: shall mean the
research, development, manufacture, importation, use and/or sale of
Homebrew Product(s). The Homebrew Field of Use excludes the
Diagnostic Field of Use, the Internal Research Field of Use and the
Personalized Research Field of Use. |
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| 1.12 |
“ Homebrew Product(s) ” shall mean a Single
Analyte Assay(s) provided as a product or a service performed by a
service provider that would constitute a Diagnostic Product with
the sole exception that it is provided prior to receipt of approval
by the FDA or comparable regulatory agency in any jurisdiction
outside of the United States. Homebrew Products exclude Diagnostic
Products, Personalized Research Products and GHI Database Products.
For purposes of the foregoing, “Single-Analyte Assays”
shall mean an assay designed for testing or measuring only a single
analyte. |
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| 1.13 |
“ Incyte Research Product ” shall have the
meaning set forth in Section 2.8. |
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| 1.14 |
“ Internal Research Field of Use ”: shall
mean (a) internal research, development, manufacture, use,
importation and/or sale of Internal Research Products; and
(b) internal research and development purposes (including
without limitation, drug discovery, development, commercialization
and regulatory filings), including the development of databases and
other products and tools marketed for use in internal research and
development purposes, including without limitation, drug discovery,
development. commercialization and regulatory filings. The Internal
Research Field of Use excludes the Diagnostic Field of Use, the
Homebrew Field of Use, and the Personalised Research Field of
Use. |
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| 1.15 |
“ Internal Research Product(s) ”: shall mean
internal research and development purposes (including without
limitation, drug discovery, development, commercialization and
regulatory filings), including the development of databases and
other products and tools marketed for use in internal research and
development purposes, including without limitation, drug discovery,
development. commercialization and regulatory filings. Internal
Research |
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*** Confidential
material redacted and filed separately with the Commission.
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Product(s) exclude Diagnostic Product(s), Homebrew Product(s)
and Personalized Research Product(s). |
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| 1.16 |
“ Layton Patent Rights ”: shall mean (a)
U.S. Patent No. 5,716,785 , “Processes for
Genetic Manipulations Using Promoters” issued
February 1, 1998; U.S. Patent No. 5,891,636 ,
“Processes for Genetic Manipulations Using Promoters”
issued April 6, 1999 (b) all counterpart foreign patent
applications claiming priority of the patent described in clause
(a) above, together with all continuations,
continuations-in-part and divisions of such patent applications,
(c) all patents issuing from any patent application described
in clause (b) above and (d) all reissues and
re-examinations of any of the foregoing patents. |
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| 1.17 |
“ Montefiore Patent Rights ”: shall mean
U.S. Patent No. 4,981,783 , “Method for Detecting
Pathological Conditions”, issued Jan. 1, 1991. |
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| 1.18 |
“ Net Sales ”: shall mean invoiced sales by
a party or a party’s Affiliate on all sales of Products (in
final form for end use) to an unaffiliated third party, and
exclusive of intercompany transfers or sales, less the following
deductions from such invoiced sales, which are actually incurred,
to the extent that they are reasonable and customary, and to the
extent that they do not exceed *** percent (***%) of invoiced sales
during any Calendar Quarter: |
(i) credits or allowances actually granted for damaged
Products, returns or rejections of Product and retroactive price
reductions;
(ii) freight, postage, shipping, customs duties and insurance
charges;
(iii) normal and customary trade, cash and quantity discounts,
allowances and credits;
(iv) uncollected amounts to the extent not exceeding ***
percent (***%) of invoiced sales for a calendar quarter; and
(v) sales, value added or similar taxes measured by the
billing amount, when included in billing.
| 1.19 |
“ Patent Rights ”: shall mean collectively,
the Cancer Marker Patent Rights, Database Patent Rights, Layton
Patent Rights, the Montefiore Patent Rights, the Seilhamer/Scott
Patent Rights, and the Stanford Patent Rights; |
| 1.20 |
“ Personalized Research Field of Use ”:
shall mean the research, development, manufacture, importation, use
and/or sale of Personalized Research Product(s). The Personalized
Research Field of Use excludes the Diagnostic Field of Use, the
Homebrew Field of Use, and the Internal Research Field of Use. |
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| 1.21 |
“ Personalized Research Product(s) ”: shall
mean a Multi-Analyte Assay(s) provided as a product or a service
containing nucleic acids or proteins that are collectively intended
to establish or identify an association between the presence or
absence of such nucleic acids or proteins and: |
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(i) |
diagnosis of the presence of, or absence of, a specific
disease(s), state(s) or condition(s) in humans; |
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(ii) |
predisposition to the presence of, or absence of, a specific
disease(s), state(s) or condition(s) in humans; |
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(iii) |
response or lack of response to disease therapy(ies) in humans
or preventative strategies in humans; |
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(iv) |
prediction of the disease course in humans, and or other
changes in state(s) or condition(s) in humans over time; |
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(v) |
clinical traits in humans for which a medical professional
should be consulted; |
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(vi) |
variation(s) in specific trait(s) and/or characteristics among
individuals; and/or |
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(vii) |
predisposition to development of toxicities to disease
therapies or preventative strategies in humans, |
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Such an assay will be considered a “Personalized Research
Product” only where the results are provided directly to the
tested individual and/or to the tested individual’s health
care provider, and where the approval by the FDA or comparable
regulatory agency in any jurisdiction outside of the United States
is not required. “Personalized Research Products”
exclude Homebrew Products, Diagnostic Products and GHI Database
Products. For purposes of the foregoing, “Multi-Analyte
Assay(s)” shall mean an assay designed for testing or
measuring more than a single analyte. |
| 1.22 |
“ Product(s) ”: shall mean GHI Database
Products, Personalized Research Products, Homebrew Products, Incyte
Research Products, Therapeutic Products and/or Diagnostic
Products. |
| 1.23 |
“ Seilhamer/Scott Patent Rights ”: shall
mean (a) US Patent No. 6,114,114 “Comparative
Gene Transcript Analysis” issued September 5, 2000, (b)
US Patent No. 5,840,484 “Comparative Gene Transcript
Analysis” issued November 24, 1998 (c) all
counterpart foreign patent applications claiming priority to the
patents described in clauses (a)and (b) above, together with
all continuations, continuations-in-part and divisions of such
patents, and (d) all reissues and re-examinations of any of
the foregoing patents. |
| 1.24 |
“ Stanford Patent Rights ”: shall mean (a)
US Patent No. 5,807,522 “Methods for Fabricating
Micro Arrays of Biological Samples” issued September 15,
1998 (b) all counterpart foreign patent applications claiming
priority of the patent described in clause (a) above, together
with all continuations, continuations-in-part and divisions of such
patent applications, (c) all patents issuing from any
patent |
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application described in clause (b) above and (d) all
reissues and re-examinations of any of the foregoing patents. |
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| 1.25 |
“ Therapeutic Product ” shall have the
meaning set forth in Section 2.8. |
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| 1.26 |
“ Valid Claim ”: shall mean a claim of an
issued and unexpired patent which has not been held unenforceable,
unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, rendered unenforceable due to
disclaimer or otherwise, or lost through an interference
proceeding. |
ARTICLE
2
LICENSE GRANT
| 2.1 |
Layton and Stanford Patent Rights . Subject to the terms
of this Agreement, Incyte hereby grants to GHI and its Affiliates,
and GHI and its Affiliates accept from Incyte a nonexclusive,
non-transferrable, limited sublicenseable (only as set forth in
Sections 2.5 and 2.6 below), world-wide license under the
Layton Patent Rights and the Stanford Patent Rights to practice and
use the subject matter within the Layton Patent Rights and the
Stanford Patent Rights in the GHI Database Field of Use, Diagnostic
Field of Use, the Homebrew Field of Use and the Personalized
Research Field of Use. |
| 2.2 |
Montefiore Patent Rights . Subject to the terms of this
Agreement, Incyte hereby grants to GHI and its Affiliates, and GHI
and its Affiliates accept from Incyte a non-transferrable, limited
sublicenseable (only as set forth in Sections 2.5 and 2.6
below), world-wide license under the Montefiore Patent Rights to
practice and use the subject matter within the Montefiore Patent
Rights in the GHI Database Field of Use, the Diagnostic Field of
Use, the Homebrew Field of Use and the Personalized Research Field
of Use. The license under the Montefiore Patent Rights shall be
exclusive in the Personalized Research Field of Use and
Co-exclusive (as described in Section 2.6) in the GHI Database
Field of Use, the Homebrew Field of Use and the Diagnostic Field of
Use. |
| 2.3 |
Cancer Marker Patent Rights . Subject to the terms of
this Agreement, Incyte hereby grants to GHI and its Affiliates, and
GHI and its Affiliates accept from Incyte a non-transferrable,
limited sublicenseable (only as set forth in Sections 2.5 and
2.6 below), world-wide license under the Cancer Marker Patent
Rights to practice and use the subject matter within the Cancer
Marker Patent Rights in the GHI Database Field of Use, the
Diagnostic Field of Use, the Homebrew Field of Use and the
Personalized Research Field of Use, only with respect to cancer.
The license under the Cancer Marker Patent Rights shall be
exclusive in the Personalized Research Field of Use with respect to
cancer, and co-exclusive (as described in Section 2.6) in the
GHI Database Field of Use, Diagnostic Field of Use and the Homebrew
Field of Use with respect to cancer. |
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| 2.4 |
Database Patent Rights and Seilhamer/Scott Patent Rights
. Subject to the terms of this Agreement, Incyte hereby grants to
GHI and its Affiliates, and GHI and its Affiliates accept from
Incyte a non-exclusive, non-transferable, non-sublicenseable ,
world-wide license under the Database Patent Rights and
Seilhamer/Scott Patent Rights to practice and use the subject
matter within the Database Patent Rights and the Seilhamer/Scott
Patent Rights in the GHI Database Field of Use, the Diagnostic
Field of Use, the Homebrew Field of Use, and the Personalized
Research Field of Use. |
| 2.5 |
Sublicenses . Except as provided in Section 2.6 and
this Section 2.5, the rights granted in Section 2.1
through 2.3 above shall not be sublicensable; provided, GHI shall
have the right to grant sublicenses to third parties under such
Patent Rights on a Product-by-Product basis to make, use, import,
sell, and offer for sale Product(s) developed by GHI or its
Affiliates. |
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| 2.6 |
Co-Exclusive License(s) — Homebrew and Diagnostic
Fields of Use . For the purposes of this Article 2.0,
“Co-Exclusive” shall mean that (a) each Party has
the right to exercise all of the rights under the Patent Rights in
question in the field of use for which the parties have
co-exclusive rights, without obligation to the other except to the
extent provided in this Agreement, and (b) neither Party alone
has the right to grant sublicenses to third parties under such
Patent Rights without express written consent of the other Party
with the following exceptions: |
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(v) |
GHI shall have the right to grant sublicenses as provided in
Section 2.5 above; |
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(w) |
Incyte shall have the right to grant licenses in the Homebrew
Field of Use and the Diagnostic Field of Use on a
Product-by-Product basis to make, use, import, sell, and offer for
sale Product(s) developed by Incyte or its Affiliates. |
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(x) |
Incyte shall have the right to grant sublicenses with respect
to the Cancer Marker Patent Rights in the Homebrew and Diagnostic
Fields of Use) with respect to individual nucleic acids or proteins
in connection with Incyte licenses of nucleic acids or proteins for
use as targets for the development of vaccines or therapeutic
products; |
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(y) |
GHI shall have the right to request that Incyte grant a
sublicense under the Montefiore Patent Rights in the Diagnostic
Field of Use and/or the Homebrew Field of Use to one (1) third
party with which GHI enters into a cross license agreement
involving the Montefiore Patent Rights, and Incyte agrees to grant
such a sublicense; |
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(z) |
Incyte shall have the right to grant a sublicense under the
Montefiore Patent Rights in the Diagnostic Field of Use and/or the
Homebrew Field of Use to one (1) third party with which Incyte
enters into a cross license agreement involving the Montefiore
Patent Rights; and |
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(zz) |
Any additional licenses under the Montefiore Patent Rights
granted by the Parties shall be subject to mutual written agreement
of the parties, and the parties shall share all revenues received
from licensees for licenses under the Montfiore Patent Rights,
after deduction of all amounts owed to the owner of the Montefiore
Patent Rights. |
| 2.7 |
No Implied Licenses . Incyte grants no licenses to GHI
under any Patent Rights except as expressly granted under this
Agreement. There are no other licenses granted by Incyte to GHI
under this Agreement, whether by implication, estoppel or
otherwise. GHI shall not use any Patent Rights for any purpose or
in any field other than as described in Sections 2.1 through
2.6. |
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| 2.8 |
Grant Back . GHI hereby grants to Incyte, and Incyte
hereby accepts, an exclusive, paid up, non-transferable,
sublicensable, worldwide license under GHI patent rights and trade
secret rights owned and Controlled by GHI, with respect to any
discoveries (to the extent such discoveries relate to the
composition of matter or use of any nucleic acids or proteins
claimed in the Cancer Marker Patent Rights) made by GHI in
connection with GHI’s use of the Cancer Marker Patent Rights
(the “Cancer Marker Improvements”) for use by Incyte
and Incyte’s sublicensees in the (i) Internal Research
Field of Use, (ii) in connection with the manufacture, use and
sale of vaccines and therapeutic products (each therapeutic product
a “Therapeutic Product”), and (iii) Diagnostic
Products in connection with the exercise of rights under (ii). |
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GHI hereby grants to Incyte, and Incyte hereby accepts, a
non-exclusive, royalty-bearing, non-transferable,
non-sublicensable, worldwide license under GHI patent rights and
trade secret rights owned and Controlled by GHI, with respect to
Personalized Research Products developed by GHI and licensed under
this Agreement or the LifeSeq Collaborative Agreement of even date
herewith (the “GHI PRx Improvements”), to
manufacture,have manufactured, sell, offer for sale, and use such
Personalized Research Products in the Internal Research Field of
Use (each an “Incyte Research Product”). |
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| 2.9 |
GHI grants no licenses to Incyte under this Agreement except as
expressly granted herein. There are no other licenses granted by
GHI to Incyte under this Agreement, wheth |
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