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:
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1.1
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“ 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
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“ 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
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“ 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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Page 1
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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
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“ 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
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“ 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
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“ 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
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“ 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)
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diagnosis of the presence of, or
absence of, a specific disease(s), state(s) or condition(s) in
humans;
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(ii)
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predisposition to the presence of,
or absence of, a specific disease(s), state(s) or condition(s) in
humans;
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(iii)
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response or lack of response to
disease therapy(ies) in humans or preventative strategies in
humans;
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(iv)
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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)
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clinical traits in humans for which
a medical professional should be consulted;
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(vi)
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variation(s) in specific trait(s)
and/or characteristics among individuals; and/or
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(vii)
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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
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“Effective
Date” :
shall mean the date first set forth above.
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1.9
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“ 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
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“ 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
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“ 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
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“ 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
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“ Incyte Research
Product ” shall have the meaning set forth in
Section 2.8.
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1.14
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“ 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
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“ 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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Page 3
*** 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
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“ 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
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“ 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
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“ 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:
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(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.
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1.19
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“ 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;
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1.20
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“ 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
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“ 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)
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diagnosis of the presence of, or
absence of, a specific disease(s), state(s) or condition(s) in
humans;
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(ii)
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predisposition to the presence of,
or absence of, a specific disease(s), state(s) or condition(s) in
humans;
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(iii)
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response or lack of response to
disease therapy(ies) in humans or preventative strategies in
humans;
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(iv)
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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)
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clinical traits in humans for which
a medical professional should be consulted;
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(vi)
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variation(s) in specific trait(s)
and/or characteristics among individuals; and/or
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(vii)
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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.
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1.22
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“ Product(s) ”:
shall mean GHI Database Products, Personalized Research Products,
Homebrew Products, Incyte Research Products, Therapeutic Products
and/or Diagnostic Products.
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1.23
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“ 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.
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1.24
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“ 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
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“ Therapeutic Product
” shall have the meaning set forth in
Section 2.8.
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1.26
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“ 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.
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ARTICLE
2
LICENSE GRANT
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2.1
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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.
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2.2
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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.
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2.3
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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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Page 6
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2.4
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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.
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2.5
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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
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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)
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GHI
shall have the right to grant sublicenses as provided in Section
2.5 above;
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(w)
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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)
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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)
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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)
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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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Page 7
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(zz)
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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.
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2.7
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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
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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”)
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