Exhibit 10.7.1
*** Confidential Treatment Requested.
Confidential portions of this document have been redacted
and have been separately filed with the Commission.
COLLABORATION AND TECHNOLOGY TRANSFER
AGREEMENT
This
Collaboration and Technology Transfer Agreement (the
“Agreement”), effective as of March 30, 2001 (the
“ Effective Date ”), is made by and between
Genomic Health, Inc., a Delaware corporation, with a place of
business at 101 University Ave, Suite 220, Palo Alto, CA 94301
(“GHI”) , and Incyte Genomics, Inc., a Delaware
corporation, with a place of business at 3160 Porter Drive, Palo
Alto, CA 94304 (“Incyte”).
BACKGROUND
Incyte and GHI
wish to collaborate on a research and development relating to
“Paraffin Extraction Technology” (as defined below);
and
GHI
desires to receive from Incyte, and Incyte desires to transfer to
GHI, certain Technology and Materials (as defined below);
and
The
parties wish to grant each other certain rights and licenses on the
terms set forth in this Agreement.
NOW THEREFORE , for and in consideration of the covenants,
conditions, and undertakings hereinafter set forth, it is agreed by
and between the parties as follows:
1. DEFINITIONS
1.1
“ 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.
1.2
“ Development Period ” shall mean the period
commencing on the Effective Date and ending fifteen
(15) months after the Effective Date, unless earlier
terminated or extended by mutual written agreement of the Parties
in accordance with the terms of this Agreement.
1.3
“ Development Program ” shall mean the
activities conducted pursuant to this Agreement, which activities
are primarily directed to the development of Paraffin Extraction
Technology.
1.4
“ 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 Incyte Field of Use and the
Homebrew Field of Use.
1.5
“ 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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(a) diagnosis
of the presence of, or absence of, a specific disease(s), state(s)
or condition(s) in humans;
(b) predisposition
to the presence of, or absence of, a specific disease(s), state(s)
or condition(s) in humans;
(c) response
or lack of response to disease therapy(ies) in humans or
preventative strategies in humans;
(d) prediction
of the disease course in humans, and or other changes in state(s)
or condition(s) in humans over time;
(e) clinical
traits in humans for which a medical professional should be
consulted; or variation(s) in specific trait(s) and/or
characteristics among individuals;
(f) variation(s)
in specific trait(s) and/or characteristics among individuals;
and/or
(g) predisposition
to development of toxicities to disease therapies or preventative
strategies in humans.
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.
1.6
“ Full-Time Equivalent ” or “ FTE
” shall mean a full-time employee, or in the case of less
than a full-time dedicated person, a full-time, equivalent
person-year performing activities under the Development
Program.
1.7
“ GHI Database Field of Use ” shall mean the
research, development, manufacture, importation, use and/or sale of
GHI Database Product(s) to end users.
1.8
“ GHI Database Products ” 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.
1.9
“ 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.
1.10 “
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
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foregoing, “Single-Analyte
Assays” shall mean a assay designed for testing or measuring
only a single analyte.
1.11 “
Improvements ” shall mean any all inventions and all
associated Intellectual Property: (a) made by Incyte or GHI
commencing on the Effective Date and continuing until twelve
(12) months after the expiration or termination of the
Development Period using (i) the Program Technology, and/or
(ii) Confidential Information provided by the other Party to
the inventing Party, and in each case, which comprise an
improvement, modification, or derivative of any of the foregoing
relating to the Program Technology , and (b) Controlled by a
Party.
1.12 “
Incyte Background Technology ” shall mean the
Intellectual Property that Incyte Controls as of the Effective Date
and during the Development Program which is necessary for the
conduct of the Development Program and the exploitation of the
Program Technology and/or the Improvements , and which is directed
to (a) the recovery and extraction of native nucleic acids,
polypeptides, peptides and/or proteins from tissues embedded in
paraffin for use in the research, development and commercialization
of assays, including without limitation microarrays
(“Paraffin Extraction”); or (b) the selective
amplification, labeling or conjugation of RNA segments in a close
to linear fashion (“RNA Amplification”). Incyte
Background Technology shall exclude those patents licensed to GHI
under the Patent License Agreement
1.13 “
Incyte Field ” shall mean all internal research and
development applications of Paraffin Extraction Technology or
Improvements, including the use of such technology to develop
therapeutic products and the use of such technology in connection
with the commercialization of research tools, such as databases,
use of a biochemical test for detecting and/or quantifying a
specific nucleic acid target sequence within a nucleic acid mixture
which is designed and intended “For Research Use Only”
or “For Investigational Use Only” or as a general
purpose laboratory reagent. For the avoidance of doubt, the Incyte
Field shall exclude any, Diagnostic Field of Use, Homebrew Field of
Use, and Personal Research Field of Use.
1.14 “
Incyte Technology ” shall mean any protocols, training
materials and computer software listed in Exhibit A to this
Agreement, in the form used by Incyte in connection with the
conduct of microarray fabrication and gene expression service
businesses in Fremont, California and St. Louis, Missouri, as of
the date of the technology transfer activities described in
Article 3 of this Agreement, which relate to (a) sample
storage and tracking; (b) LIMS systems; (c) microarray
manufacturing protocols; (d) hybridization protocols;
(e) quality control and quality assurance protocols;
(f) microarray scanning protocols; and (g) data
analysis.
1.15 “
Intellectual Property ” shall mean trade secrets,
Patents, copyrights, Know-How, and similar rights of any type under
the laws of any governmental authority, domestic or foreign,
including all applications and registrations relating to any of the
foregoing.
(a) “
Patents ” shall mean (i) all patents worldwide
including without limitation, all substitutions, reissues,
renewals, reexaminations, patents of addition, and inventor’s
certificates thereof; (ii) all term extensions or other
government action which provides exclusive rights to an Invention
beyond the original patent expiration date; and (iii) all
pending patent applications (including provisional applications,
divisions, continuations, continued prosecutions and
continuations-in-part).
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separately with the Commission.
(b) “
Know-How ” shall mean all knowledge, ideas,
inventions, data, instructions, biological or other tangible
materials, processes, formulas, expert opinions and information,
including, without limitation, biological, chemical, analytical,
clinical, manufacturing and quality control data and information,
materials, methods, processes, techniques, and data. For the
avoidance of doubt, Know-How does not include any Patent
Rights.
1.16 “
Net Sales ”: shall mean invoiced sales by GHI or a GHI
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:
(a) credits
or allowances actually granted for damaged Products, returns or
rejections of Product and retroactive price reductions;
(b) freight,
postage, shipping, customs duties and insurance charges;
(c) normal
and customary trade, cash and quantity discounts, allowances and
credits; and
(d) uncollected
amounts to the extent not exceeding *** percent (***%) of invoiced
sales for a calendar quarter; and
(e) sales,
value added or similar taxes measured by the billing amount, when
included in billing.
1.17 “
Paraffin Extraction ” shall mean the recovery and
extraction of native nucleic acids, polypeptides, peptides and/or
proteins from tissues embedded in paraffin.
1.18 “
Paraffin Extraction Technology ” shall mean all
Program Technology relating to the recovery and extraction of
native nucleic acids, polypeptides, peptides and/or proteins from
tissues embedded in paraffin and its use in the research,
development and commercialization of assays, including without
limitation microarrays. Paraffin Extraction Technology excludes RNA
Amplification Technology.
1.19 “
Party ” or “ Parties ” shall mean
individually Incyte or GHI, and collectively Incyte and
GHI.
1.20 “
Patent License Agreement ” shall mean that certain
patent license agreement by and between Incyte and GHI, titled the
“Patent License Agreement”, as of March 30, 2001,
including without limitation the rights granted thereunder in and
to the Cancer Marker Patent Rights, Layton Patent Rights,
Montefiore Patent Rights, and Stanford Patent Rights (each as
defined therein).
1.21 “
Personal 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 Incyte Field of Use.
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1.22 “
Personal Research Products ” shall mean 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:
(a) diagnosis
of the presence of, or absence of, a specific disease(s), state(s)
or condition(s) in humans;
(b) predisposition
to the presence of, or absence of, a specific disease(s), state(s)
or condition(s) in humans;
(c) response
or lack of response to disease therapy(ies) in humans or
preventative strategies in humans;
(d) prediction
of the disease course in humans, and or other changes in state(s)
or condition(s) in humans over time;
(e) clinical
traits in humans for which a medical professional should be
consulted;
(f) variation(s)
in specific trait(s) and/or characteristics among individuals;
and/or
(g) predisposition
to development of toxicities to disease therapies or preventative
strategies in humans.
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.
1.23 “
Products ” shall mean GHI Database Products,
Personalized Research Products, Homebrew Products and/or Diagnostic
Products.
1.24 “
Program Technology ” shall mean all Intellectual
Property created by Incyte or GHI after the Effective Date and
during the Development Period (i) in the course of performing
the Development Program, or (ii) using Confidential
Information provided by the other Party to the inventing Party in
connection with the Development Program.
1.25 “
RNA Amplification ” shall mean the selective
amplification, labeling or conjugation of RNA segments in a close
to linear fashion.
1.26 “
RNA Amplification Technology ” shall mean all Program
Technology relating to the selective amplification, labeling or
conjugation of RNA segments in a close to linear
fashion.
1.27 “
Term ” shall mean the period set forth in
Section 12.1.
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1.28 “
Third Party ” shall mean any Party other than Incyte
or GHI.
1.29 “
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.
2. DEVELOPMENT
PROGRAM
2.1
Development Program .
2.1.1
Development Program . The parties shall conduct the
Development Program during the Development Period. Each Party
agrees to use diligent efforts to conduct the Development Program
in accordance with the terms of this Agreement. Subject to the
terms of this Agreement, including without limitation the
definition of the field of research and the provisions of Section
2.1.3 regarding Development Program Staffing, GHI shall control
decisions regarding the direction of research efforts undertaken in
connection with the Development Program.
2.1.2
Substitution and Addition of Projects . Upon notice from GHI
to Incyte, individual projects in the Development Program may be
dropped, added or changed, provided that such changes do not extend
the Development Program into areas other than Paraffin Extraction
Technology, and provided further that such changes shall not affect
the resources to be provided by Incyte under this Agreement or the
duration of the Development Period unless Incyte has agreed in
writing to such changes.
2.1.3
Development Program Staffing .
(a) During
the Development Program, unless otherwise agreed in writing by
Incyte and GHI, Incyte will devote to the conduct of the
Development Program three (3) Incyte FTEs during the
Development Period. In addition, in GHI’s sole discretion,
GHI may provide up to three (3) GHI FTEs to assist with the
Development Program.
(b) The
Development Program will be conducted at Incyte under the direction
of *** (the “Principal Director”). In the event the
Principal Director becomes unavailable to participate in the
Development Program for any reason, and the parties are unable to
agree on a reasonable successor with comparable skills and
qualifications within ninety (90) days following the date he
becomes unavailable, GHI may terminate this Agreement . GHI’s
payment obligations under Section 4.1.1 shall be suspended during
any such period of unavailability or until the parties agree on
such reasonable successor.
(c) Incyte
and GHI shall agree in advance on the technical and scientific
qualifications of the GHI FTEs and other Incyte FTEs who will
participate in the Development Program. If GHI becomes dissatisfied
with the work of any Incyte FTE participating in the Development
Program, GHI shall have the right to so notify Incyte in writing,
and Incyte will use reasonable efforts to identify an alternate FTE
with appropriate qualifications.
2.1.4
Visiting Personnel . It is understood that in the course of
the Development Program there may be occasions where one
Party’s personnel (“Visiting Personnel”) may
be
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stationed at the other
Party’s facilities on a temporary basis. Such Visiting
Personnel shall agree to be bound by all orders, rules and
regulations pertaining to the hosting Party’s facilities
during the entire time at such facilities.
2.2
Development Program Funding .
2.2.1
Funding . Except for the amounts provided by GHI pursuant to
Article 4 to fund the Development Program, each Party shall
bear its own costs in conducting the Development
Program.
2.2.2
Third Party Technology . GHI will be responsible for
determining whether the parties should cooperate in obtaining
licenses to Intellectual Property or technology of one or more
Third Parties for the conduct of the Development Program and for
acquiring such licenses for purposes of the Development Program.
Each Party shall be responsible for acquiring such Intellectual
Property or technology of one or more Third Parties as it considers
necessary or desirable in connection with its use of Program
Technology following completion or other termination of the
Development Program.
2.2.3
Capital Expenditures . If GHI determines that the conduct of
the Development Program can be facilitated by the purchase of
specialized capital equipment, GHI shall be responsible for
obtaining such equipment, at GHI’s expense, and GHI shall own
all such equipment.
2.3
Record Keeping: Reports .
2.3.1
Records . Each Party shall maintain records of its
activities under the Development Program in sufficient detail and
in good scientific manner as will properly reflect all work done
and results achieved in the performance of the Development Program.
Each Party shall provide the other with access to all records,
materials and data generated with respect to the Development
Program at reasonable times and in a reasonable manner.
2.3.2
Reports . Each Party shall report and provide to the other
Party with copies of all data, results, information, inventions,
discoveries and developments achieved or obtained in the course of
performing the Development Program, on an on-going basis throughout
the Development Period or as otherwise specified as part of the
Development Program.
3. TECHNOLOGY
TRANSFER
3.1
Disclosures . Incyte shall provide the Incyte Technology to
GHI according to a schedule described generally in Exhibit A,
as such schedule may be modified by mutual agreement of Incyte and
GHI. The LIMS system portion of the Incyte Technology will be
transferred to GHI either digitally via the internet or modem to
GHI or via the “load and leave” process, where the LIMS
system will be installed by Incyte onto GHI’s equipment.
Incyte will retain title, possession and control over all physical
forms of property at all times during the installation process.
Upon completion of the installation, Incyte shall not leave with
GHI any form of tangible personal property other than instruction
documentation. GHI is authorized to make a backup copy of the LMIS
system for archival purposes.
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3.2
Assistance . Incyte agrees to provide GHI with up to three
(3) days of training, as GHI may reasonably request, following
installation of the LIMS system at GHI (to occur during 2001), to
understand and implement the sample storage and tracking and LIMS
system portions of the Incyte Technology. Prior to
December 31, 2002, at GHI’s reasonable request, and
subject to availability, Incyte shall allow up to five (5) GHI
employees to participate in Incyte’s periodically scheduled
training sessions for new Incyte employees or customers with
respect to microarray manufacturing protocols, hybridization
protocols, quality control and quality assurance protocols,
microarray scanning protocols, and data analysis portions of the
Incyte Technology. Upon mutual agreement of Incyte and GHI, GHI
employees may also visit Incyte facilities for such periods as GHI
and Incyte may agree to observe Incyte’s use of the Incyte
Technology. If GHI wishes to obtain any additional services from
Incyte regarding GHI’s implementation or modification of the
Incyte Technology, Incyte’s obligation to provide such
services will be subject to a separate, written agreement between
the parties that will describe the services to be provided by
Incyte and the fees payable by GHI.
3.3
Incyte Know How License . Incyte hereby grants to GHI a
worldwide, perpetual, irrevocable, non-transferable (except as
provided in Section 14.6, below), royalty-free, fully paid-up,
non-exclusive license under the Incyte Know-How, as is Controlled
by Incyte, to develop, make, use, duplicate, modify, make
derivative works, publicly perform, display, and disclose the
Incyte Technology for the internal operation of GHI’s
businesses, to exploit the rights and license granted under the
Patent License Agreement and/or granted herein this Agreement, in
each case in the GHI Database Field of Use, Diagnostic Field of
Use, Homebrew Field of Use, and Personal Research Field of
Use.
3.4
Retained Rights . It is understood and agreed that no
license or right is granted by Incyte to GHI under this
Article 3 other than as expressly granted herein. No other
license or rights, including without limitation any license or
right to any other intellectual property owned or controlled by
Incyte, shall be granted or created by implication, estoppel or
otherwise.
4. PAYMENTS;
CONSIDERATION
4.1
Development Program Funding .
4.1.1
Funding . In full consideration for Incyte’s
undertaking the Development Program, GHI shall pay to Incyte ***
Dollars ($***). GHI shall pay the foregoing amount in equal
quarterly installments during the 2002 calendar year, with each
such payment due during the first ten (10) business days of
each such quarter.
4.1.2
Limitations . Except as provided in Section 2.2 or this
Section 4.1, in no event shall GHI be responsible for any
other costs, expenses or obligations incurred by Incyte in
performing the Development Program without GHI’s prior
written consent.
4.2
Technology Transfer Payment . In full consideration for the
disclosure and transfer of the Incyte Technology pursuant to
Section 3.1, the assistance provided by Incyte pursuant to
Section 3.2, and the rights and licenses granted to GHI under
Section 3.3, GHI shall pay to Incyte *** Dollars ($***). GHI
shall pay the foregoing amount
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in equal quarterly installments
during the 2002 calendar year, with each such payment due during
the first ten (10) business days of each such
quarter.
4.3
Royalties . In consideration for the licenses granted to GHI
by Incyte under Section 6.2.2(b) hereof, on the Effective
Date, GHI shall pay to Incyte royalties on Net Sales of *** percent
(***%) for Personalized Research Product(s) and Homebrew Product(s)
and *** percent (***%) for Diagnostic Product(s), in each case,
which Product(s) would, but for the licenses granted herein,
infringe a Valid Claim under (i) the Incyte Background
Technology directed to RNA Amplification and/or (ii) the RNA
Amplification Technology.
4.3.1
Combination Products . In the event that a Product is sold
in combination with other product(s) and/or service(s) for which no
royalty would be due hereunder if sold separately, Net Sales from
such combination sales for purposes of calculating the amounts due
under this Section 4.3 shall be calculated by multiplying the
Net Sales of the combination product by the fraction A/(A + B),
where A is the average gross selling price during the applicable
calendar quarter of the Product sold separately to the same
category of customers (e.g. patients, health care providers, or
Diagnostic Product distributors) and B is the average gross selling
price during the applicable calendar quarter of the other
product(s) and/or services. In the event that such separate sales
were not made during the previous calendar quarter then the Net
Sales shall be calculated by multiplying the Net Sales of the
combination product by the fraction C/(C + D), w
