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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material redacted and filed 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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material redacted and filed separately with the Commission.
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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material redacted and filed separately with the Commission.
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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material redacted and filed separately with the Commission.
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), where C is the
average cost of goods sold during the applicable calendar quarter
of the Product and D is the average cost of good sold during the
applicable calendar quarter of the other product(s) and/or
service(s) , in each case calculated in accordance with standard
and customary accounting principles.
4.3.2
Third Party Royalties . In the event that GHI pays royalties
to third parties in connection with the sale of Products either
under agreements for patent rights (including applications
therefor) or other technologies
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