1
***** Certain information on this page has EXHIBIT 10.24
been omitted and filed separately with the
Securities and Exchange Commission. Confidential REDACTED FOR
treatment has been requested with respect CONFIDENTIALITY
to the omitted portions.
CONFIDENTIAL TREATMENT
REQUESTED
The asterisked portions of this document have been
omitted and are filed separately with the Securities and
Exchange Commission
COLLABORATIVE AGREEMENT
between
INCYTE PHARMACEUTICALS, INC
and
DIADEXUS, LLC
2
This Agreement is entered into as of February 17, 2000 by and between
diaDexus, a Delaware limited liability company ("diaDexus"), having its
principal place of business at 0000 Xxxxxxxx Xxxxx, Xxxxx Xxxxx, Xxxxxxxxxx
00000, and Incyte Pharmaceuticals, Inc., a Delaware corporation ("Incyte"),
having its principal place of business at 0000 Xxxxxx Xxxxx, Xxxx Xxxx, XX
00000, and shall be retroactive to September 2, 1997, (the "Effective Date").
RECITALS
WHEREAS Incyte owns or has rights in certain patent rights and know-how
regarding certain high-throughput partial cDNA sequencing, cloning, and data
analysis technologies; and
WHEREAS, Incyte has compiled and is compiling, and owns certain information
and data regarding certain cDNAs in confidential databases which may be useful
in the study of biological phenomena; and
WHEREAS, Incyte owns, or has rights in, certain patent rights and know-how
regarding certain genomic DNAs, cDNAs as well as certain of the proteins they
encode; and
WHEREAS, diaDexus desires to extend, expand, and replace the existing
Collaborative LiveSeq and PathoSeq Agreements between Incyte and diaDexus dated
2 September 1997;
WHEREAS, diaDexus desires to obtain extended and expanded access to
Incyte's LifeSeq(R) Database Product(s) (as defined below), and to obtain
licenses to use Incyte's patent rights and know-how under the LifeSeq(R)
Database Products, to conduct research and development of diagnostics and
pharmaceuticals, as specified herein.
NOW, THEREFORE, the Parties agree as follows:
1.0 DEFINITIONS
The following terms shall have the following meanings:
1.1 "Access Term": shall mean the period commencing on the Effective Date and
ending on September 2, 2003, during which diaDexus shall have access to the
LifeSeq(R) Database Product(s) under the terms and conditions of this
Agreement.
1.2 "Annotation Information" shall mean the information associated with
individual cDNAs contained in each and/or all of the LifeSeq(R) Database
Product(s), as applicable including, but not limited to, tissue expression
information, homology information, gene cluster identifiers, etc.
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1.3 "Antisense Field of Use" shall mean the treatment or prevention of any
disease, state or condition in humans by use of one or more
oligonucleotides or modified oligonucleotides which bind either (i) to mRNA
to block the translation of mRNA in vivo to inhibit, prevent and/or alter
protein production, or (ii) to DNA to prevent the transcription of DNA into
the mRNA copy of the gene in vivo. The Antisense Field of Use does not
include the sale or license to third parties of Database Information or
Gene Product(s) as research tools, or the use of Database Information or
Gene Product(s) to develop database products or services for sale or
license to third parties.
1.4 "Antisense Product(s)" shall mean oligonucleotides or modified
oligonucleotides derived from or targeted to Gene Product(s) for use in the
Antisense Field of Use.
1.5 "cDNA Clone" shall mean an individual plasmid vector and cDNA insert, which
cDNA insert is usually a partial gene, and not necessarily a full length
gene.
1.6 "Coding Sequence" shall mean the complete DNA sequence of those regions
within a gene that encode amino acids, i.e., the DNA sequence that would be
found between the initiation codon and the stop codon in a full-length cDNA
clone of mRNA transcribed and spliced from the gene.
1.7 "Database Information" shall mean all or any part of the Annotation
Information and DNA sequence Information which is contained in each and/or
all of the LifeSeq(R) Database Product(s), as applicable.
1.8 "Designated Gene Product" shall mean a given Gene Product which is selected
for research and development, or other use by diaDexus in accordance with
the terms and conditions of this Agreement, and is "Used by diaDexus", as
defined below, during the Access Term.
1.9 "diaDexus" shall mean diaDexus, LLC and its Affiliates.
1.10 "diaDexus Affiliates" shall mean any corporation, firm, partnership, or
other legal entity, which is directly or indirectly owned or under common
ownership by diaDexus to the extent of which the common stock or other
equity ownership thereof is one hundred percent (100%) owned by diaDexus;
provided however, that where local laws require a minimum percentage of
local ownership, the status of diaDexus Affiliate will be established if
diaDexus directly or indirectly owns or controls one hundred percent (100%)
of the maximum ownership percentage that may, under such local laws, be
owned or controlled by foreign interests.
1.11 "Diagnostic Field of Use" shall mean the use of Designated Gene Products
for the development, commercialization and use of Validated Markers for (a)
the diagnosis and/or monitoring of any disease, state or condition in
humans, (b) the selection of a method of treatment of any disease state or
condition in humans (including side effects of therapeutic treatments), (c)
the assessment of prediction of responses in humans to a drug or other
method of treating a disease, including
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without limitation the determination of efficacy and the toxicity of
drug(s), provided, however, that the Diagnostic Field of Use does not
include the commercialization of multi-gene diagnostic products or
services (e.g. multi-gene diagnostic products or services) using more
than twenty (20) Validated Markers, unless such Validated Markers are
proteins even if not Regulatory Approved. The Diagnostic Field of Use
does not include the sale or license to third parties of Database
Information or Gene Product(s) as research tools, or the use of Database
Information or Gene Product(s) to develop database products or services
for sale or license to third parties. For the purposes of this Agreement,
the rights of diaDexus to do diagnostics testing for research purposes
shall be for rDx Kits and rDx Services as defined in the Collaboration
and License Agreement among Incyte, diaDexus and Xxxxx Xxxxx Xxxxxxx.
Notwithstanding the foregoing sentence, the Diagnostic Field of Use shall
include the right to sell or license information or software necessary
for the analysis or interpretation of tests involving the use of
Validated Markers.
1.12 "Diagnostic Product(s)" shall mean any product directed to or service
derived from Gene Product(s) for use in the Diagnostic Field of Use.
1.13 "DNA Sequence Information" shall mean nucleotide sequences incorporated
into the LifeSeq(R) Database Product(s) provided by Incyte to diaDexus
pursuant to this Agreement.
1.14 "Drug Product(s)" shall mean compositions of matter which are ligands or
inhibitors of Gene Product(s). These include small molecules and
antibodies (including Therapeutic Antibodies) which are agonists, inverse
agonists, antagonists, and/or modulators of Gene Product(s) for use in
the treatment of any disease, state or condition in humans; provided,
however, that Drug Product(s) shall not include Therapeutic Protein
Product(s) or Antisense Product(s).
1.15 "Full Length Clone" shall mean, with respect to a given gene, a specific,
purified cDNA Clone developed or acquired by Incyte, containing the
Coding Sequence of such gene.
1.16 "Full Length Contig" shall mean, with respect to a given gene, DNA
Sequence Information contained in the LifeSeq(R) Database Product(s) that
corresponds to the Coding Sequence of such gene.
1.17 "Gene Product(s)" shall mean (i) all Database Information and any cDNA
Clone(s) corresponding to a given gene, provided to diaDexus in
accordance with and during the term of this Agreement, and (ii) products
or materials that are directly developed or directly derived therefrom by
diaDexus i.e., partial cDNAs, genes, full length cDNAs corresponding
thereto, RNAs, peptides, polypeptides and proteins encoded thereby.
1.18 "Incyte Know-How" shall mean the information, software, data, biological
materials and/or other materials consisting of or directly and solely
relating to Database Information which is (a) proprietary to Incyte
either at the time of
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disclosure to diaDexus or at time of Use By diaDexus and (b) not known to
diaDexus, all to the extent and only to the extent that Incyte has the
right to grant licenses, immunities or other rights to diaDexus thereunder;
provided, however, that Incyte Know-How shall exclude Incyte Patent Rights
and all know-how arising under Incyte Proprietary Programs; and further
provided that genomic DNA sequence information which is part of the public
domain or was already Known to diaDexus does not render cDNA Database
Information non-proprietary or non-confidential except to the extent that
such genomic DNA sequence information has been specifically and materially
established by diaDexus as exon region(s) (i) via standard molecular
biology laboratory techniques, or (ii) through the use of a suitable
computer algorithm with subsequent confirmation through laboratory
research, as can be demonstrated by diaDexus.
1.19 "Incyte Patent Rights" shall mean the patents and/or patent applications
owned or controlled by Incyte which (i) claim the composition of matter of
Gene Product(s) and/or (ii) arise solely from the generation of Database
Information and claim the use of Gene Product(s) with respect to
Product(s), throughout the world, as well as reissues, reexaminations,
divisionals, provisionals, continuations or continuations-in-part thereof
or therefor, all to the extent and only to the extent Incyte has the right
to grant licenses, immunities or other rights thereunder; provided,
however, that Incyte Patent Rights shall exclude all patent rights arising
under Incyte Proprietary Programs.
1.20 "Incyte Proprietary Program(s)" shall mean an internal research and
development program of Incyte which involves investment by Incyte intended
to develop discoveries, inventions, data or information (whether or not
patentable) beyond that consisting of Database Information. Incyte
Proprietary Programs are independent of those services regularly performed
by Incyte to produce or generate DNA Sequence Information and Annotation
Information intended to be released to the LifeSeq(R) Database Product(s).
1.21 "Incyte Technology" shall mean, collectively, Incyte Know-How and Incyte
Patent Rights.
1.22 "Installation Site" shall mean the research facilities of diaDexus, at the
above specified address.
1.23 "Lead/Product Development" shall mean formal preclinical studies under
controlled condition, such as Good Laboratory Practice (GLP) conditions.
1.24 "LifeSeq(R) Gold Database" shall mean the version of Incyte's LifeSeq(R)
Gold database of human Annotation Information, DNA Sequence Information and
related software and documentation, most recently made available by Incyte
to its nonexclusive subscribers for that database as of the Effective Date,
as described in Exhibit B, and all additions, enhancements and
modifications to that database made by Incyte and provided by Incyte on a
nonexclusive basis to its subscribers for that database without additional
charge. In no event, however, shall the foregoing be construed to permit
Incyte to charge diaDexus for
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additions, enhancements and modifications to the database that do not
represent substantial and material increases in such database's
functionality.
1.25 "LifeSeq(R) Database Product(s)" shall mean the "LifeSeq(R) Gold
Database, the LifeTools(TM) Product and the PathoSeq(R) Database as
defined herein in Exhibits B, C, and D.
1.26 "LifeSeq Subscriber" shall mean any organization that is listed in
Appendix F, which list shall be updated periodically by Incyte.
1.27 "LifeTools(TM) Product" shall mean the version of Incyte's set of
proprietary software products providing sequence-analysis and
data-management tools for handling complex genomic information from
multiple sources most recently made available by Incyte to its
nonexclusive subscribers for that database as of the Effective Date,
together with related software and documentation, as described in Exhibit
C, and all additions, enhancements, and modifications to those software
products made by Incyte and provided by Incyte on a nonexclusive basis to
its customers for those software products without additional charge. In
no event, however, shall the foregoing be construed to permit Incyte to
charge diaDexus for additions, enhancements and modifications to those
software products that do not represent substantial and material
increases in such software products' functionality.
1.28 "Net Sales" shall mean with respect to each given country, invoiced sales
by diaDexus or it sublicensees on all sales of Product (in final form for
end use) to an unaffiliated third party (whether an end-user, a
distributor or otherwise), and exclusive of intercompany transfers or
sales, less the following deductions from such gross amounts which are
actually incurred, to the extent that they are reasonable and customary.
(a) credits or allowances actually granted for damaged Products,
returns, recalls or rejections of Product and retroactive price
reductions or rebates;
(b) freight, postage, shipping, customs duties, tariffs, excises and
insurance charges;
(c) normal and customary trade, cash and quantity discounts, allowances
and credits;
(d) sales, value added or similar taxes measured by the billing amount,
when included in billing;
(e) charge back payments and rebates granted to managed health care
organizations or to federal, state and local governments, their agencies,
and purchasers and reimbursers or to trade customers;
(f) commissions paid to third parties other than sales personnel and
sale representatives or sales agents; and
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(g) rebates (or equivalents thereof) granted to or charged by national,
state or local governmental authorities in countries other than the
United States.
In the event a Product is sold in the form of a Combination Product, Net
Sales from such Combination Product, for purposes of determining royalty
payments, shall be determined by multiplying the actual Net Sales of such
Combination Product during the applicable royalty reporting period, by the
fraction A/(A+B) where: A is the average sale price of the Product
contained in the Combination Product: when sold separately by diaDexus or
sublicensee; and B is the average sale price of the other product(s)
included in the Combination Product when sold separately by diaDexus or
sublicensee, in each case during the applicable royalty reporting period
or if sales of both the Product and/or other products did not occur in
such period, then in the most recent royalty reporting period in which
sales of both occurred. In the event that such average sale price cannot
be determined for both the Product and all other product(s) included in
the Combination Product, Net Sales for the purpose of determining royalty
payments shall be calculated by multiplying the Net Sales of the
Combination Products by the fraction of C/C+D where C is the fair market
value of the Product and D is the fair market value of all other active
compounds and/or active ingredients included in the Combination Product.
In such event Incyte and diaDexus shall negotiate in good faith to arrive
at a determination of the respective fair market values of the Product and
all other active compounds and/or active ingredients included in the
Combination Product. For the purposes of the definition of Net Sales,
"Combination Product" shall mean a product which comprises two (2) or more
active ingredients at least one (1) of which is a Product, wherein an
"active ingredient" is a biologically active ingredient which causes one
or more of the direct clinical therapeutic effects for which the Product
is intended (or diagnostic results in the case of a Diagnostic Product),
and excluding diluents, vehicles, drug delivery systems, adjuvants or
other ingredients which do not by themselves have such therapeutic
effect(s).
1.29 "PathoSeq(R) Database" shall mean the version of Incyte's PathoSeq(R)
database of microbial DNA Sequence Information and related software and
documentation, most recently made available by Incyte to its nonexclusive
subscribers for that database as of the Effective Date, as described in
Exhibit D and all additions, enhancements and modifications to that
database made by Incyte and provided by Incyte on a nonexclusive basis to
its subscribers for that database without additional charge. In no event,
however, shall the foregoing be construed to permit Incyte to charge
diaDexus for additions, enhancements and modifications to the database
that do not represent substantial and material increases in such
database's functionality.
1.30 "Phase III Clinical Trial" shall mean that portion of the clinical
development program which provides for the continued trials of a specific
Drug Product, Antisense Product, and/or Therapeutic Protein Product on
sufficient numbers of patients to establish the safety and efficacy of
such Drug Product, Antisense Product, and/or Therapeutic Protein Product
to a standard consistent with that necessary to support Regulatory
Approval required to market and sell the Drug Product, Antisense
Product, and/or Therapeutic Protein Product for the
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applicable indication(s) in any country in the world.
1.31 "Product(s)" shall mean Drug Product(s), Diagnostic Product(s),
Antisense Product(s) and/or Therapeutic Protein Product(s), singly or
in combination as applicable.
1.32 "Product Development Milestone" shall mean (i) in the case of a
small-molecule Drug Product, the successful configuration of an assay
for drug screening; (ii) in the case of a Therapeutic Antibody Product
initiation of screening (iii) in the case of a Therapeutic Protein
Product or Antisense Product, initiation of studies in animals using
recombinant protein the purpose of which is to provide supporting
evidence for the efficacy of the Therapeutic Protein Product or
Antisense Product in an animal model of a human disease.
1.33 "Regulatory Approval" shall mean, with respect to any country in the
world, applications or approvals of any national, supra-national,
regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, necessary for the
lawful manufacture, distribution, use, import, export or sale of
Product(s) in such country.
1.34 "Research Field of Use" shall mean all internal research applications
of Gene Product(s), associated with conducting research in the
Diagnostic Field of Use, the Antisense Field of Use, the Therapeutic
Field of Use and in the identification, development and
commercialization of Drug Products. The Research Field of Use does not
include the sale or license to third parties of Database Information or
Gene Product(s) as research tools, or the use of Database Information
or Gene Product(s) to develop database products or services for sale or
license to third parties.
1.35 "Therapeutic Antibody" shall mean (a) a molecule containing four (4)
polypeptide chains, consisting of two (2) identical light chains and
two (2) identical heavy chains that are held together by disulfide
bonds to form two (2) identical antigen binding sites or (b) any
combination, fragment or altered form of an antibody containing at
least one antigen binding site that could be used for a therapeutic
purpose.
1.36 "Therapeutic Field of Use" shall mean the treatment or prevention of
any disease, state or condition in humans by any means, (including
without limitation, gene therapy and Vaccines), excluding the
Antisense Field of Use. The Therapeutic Field of Use does not include
the sale or license to third parties of Database Information or Gene
Product(s) as research tools, or the use of Database Information or
Gene Product(s) to develop database products or services for sale or
license to third parties.
1.37 "Therapeutic Protein Product(s)" shall mean any product or service,
including gene therapy and Vaccines, which uses a protein, peptide or
polypeptide which is a Gene Product in the treatment or prevention of
any disease, state or condition in humans, including gene therapy
products; provided however, that Therapeutic Protein Product(s) does
not include Antisense Product(s).
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1.38 "Used or Use By diaDexus" shall mean the first use by diaDexus, of
Database Information or a proprietary cDNA Clone obtained from Incyte
hereunder, in each case which at the time of such use is either
included in the Incyte Know-How or the Incyte Patent Rights, and
provided that such first use by diaDexus meets any or all of the
following criteria:
(a) diaDexus requests and obtains from Incyte hereunder such cDNA Clone
from the LifeSeq(R) Database Product(s) which contains DNA Sequence
Information that partially or completely codes for a Gene Product; or
(b) diaDexus uses such DNA Sequence Information to construct,
synthesize or otherwise obtain a hybridization probe to isolate a
nucleotide sequence that partially or completely codes for a Gene
Product (e.g. a cDNA, RNA or genomic clone); or
(c) diaDexus uses such DNA Sequence Information to synthesize or have
synthesized a peptide or oligonucleotide (DNA or RNA) whose sequence is
encoded by a Gene Product; or
(d) diaDexus uses such DNA Sequence Information or such cDNA Clone in
the identification of putative exon region(s) in genomic DNA
sequence(s); or
(e) such Database Information is specifically disclosed in a diaDexus
patent or patent application.
1.39 "Vaccines" shall mean a prophylactic or therapeutic agent whose primary
mode of action is the induction of a humoral and/or cell-mediated immune
response directed against an antigen.
1.40 "Validated Marker(s)" shall mean Designated Gene Product(s) whose
significance as indicators of either (a) the cause, history, stage,
progression or prognosis of a disease, or (b) an actual or likely
response to a drug that has been established by significant results
from analysis of appropriate specimens from human preclinical or
clinical studies.
1.41 "Valid Claim" shall mean a claim of an issued and unexpired Incyte
Patent Right 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, and which has not been lost through an interference proceeding.
2.0 ACCESS
2.1 Access to LifeSeq(R) Database Product(s)
Access Grant. Incyte hereby grants to diaDexus, non-exclusive access and
the right to use the LifeSeq(R) Database Product(s) and Database
Information at the Installation Site, solely in accordance with the
terms and conditions of this
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Agreement.
2.1.1 Updated Releases and Updates. During the Access Term, Incyte shall
provide diaDexus at the Installation Site with data and all updates
of newly released Database Information, and all updated software
releases of the LifeSeq(R) DataBase Product(s), that constitute
LifeSeq(R) Database Products. During the Access Term, Incyte and
diaDexus may, by mutual written agreement, agree that Incyte shall
have the right to commence providing updates to the LifeSeq(R)
Database Product(s) via on-line services via secure connections.
2.1.2 Database and Software Access Plan. diaDexus shall develop and
implement throughout the Term a Database an Software Access Plan.
Such plan shall be substantially in the form of Exhibit E and shall
establish mechanisms to document access to the LifeSeq(R) Database
Product(s) and assure compliance with the grant of such access.
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2.2 Use Restrictions and Security Requirements
2.2.1 Ownership. diaDexus hereby acknowledges that (a) Incyte represents
that it has expended significant resources and efforts to develop
the LifeSeq(R) Database Product(s) and the Database Information, (b)
the LifeSeq(R) Database Product(s) represent highly valuable and
confidential assets, (c) Incyte is willing to grant diaDexus access
to the LifeSeq(R) Database Product(s) in reliance upon the agreement
by diaDexus that it shall use commercially reasonable efforts to
protect the LifeSeq(R) Database Product(s) from unauthorized
disclosure or use, and (d) the LifeSeq(R) Database Product(s) at all
times during the term of this Agreement shall remain the sole and
exclusive property of Incyte.
2.2.2 Designated CPU's at the Installation Sites. The LifeSeq(R) Database
Product(s), including the DNA Sequence Information, shall only be
installed at the Installation Site on the hard disk of up to two (2)
designated computers and/or file servers whereby additional multiple
workstation(s) do not contain copy(s) of the LifeSeq(R) Database
Product(s) installed, other than ephemerally, on the workstation
hard disk(s). An additional copy of the LifeSeq(R) Database
Product(s) may reside on the same computer(s) or file server(s)
provided that this copy is solely used to install and test new
versions and releases of the LifeSeq(R) Database Product(s). In
addition, a back-up computer or file server may be designated such
that a copy of the LifeSeq(R) Database Product(s) may be installed
on this computer in the event that the primary computer fails. Under
no circumstances will the LifeSeq(R) Database Product(s), be
installed on any designated CPU(s) in a manner which would allow
unauthorized access (e.g. unauthorized third party access via the
Internet). Remote access to servers and/or workstation(s) by
diaDexus, is permissible provided that diaDexus complies with
applicable portions of the Agreement. All other database or software
is prohibited.
2.2.3 Permitted Use
(a) During the Access Term, diaDexus shall have the right to use
the LifeSeq(R) Database Product(s) solely for diaDexus' own internal
use at the Installation Site, in commercially reasonable secure work
facilities of diaDexus in accordance with the terms and conditions
of this Agreement and the Database and Software Access Plan.
(b) diaDexus shall not disclose the LifeSeq(R) Database Product(s)
to any third party and shall not disclose or transfer Database
Information or Incyte Technology, or any portion thereof, to any
third party except for Database Information and corresponding cDNA
Clone(s) specifically regarding a Designated Gene Product and in
each event solely in accordance with the provisions of Sections
2.3.4 and 5.0
(c) Solely for purposes of system integration and/or to facilitate
data analysis and relational analysis (e.g. extraction of DNA
Sequence
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Information for homology analysis by diaDexus search algorithms),
diaDexus shall have the right to reproduce, adapt, modify and
prepare derivative works based upon the LifeSeq(R) Database
Product(s) ("Modifications") solely for internal use by diaDexus in
their research and development programs. diaDexus shall own any
such Modifications except for any portions of any LifeSeq(R)
Database Products contained therein. Any portions of any LifeSeq(R)
Database Products contained within such Modifications shall be kept
in confidence in the same manner as, and shall be subject to the
same terms and conditions as LifeSeq(R) Database Products not
contained within such Modifications. Incyte shall have no
obligations to support any such Modifications. diaDexus shall not
acquire by reason of this subsection (c) any ownership of any
LifeSeq(R) Database Product(s), any portions thereof or any title
or rights therein. diaDexus shall not distribute copies of, or
provide access to, any portions of any LifeSeq(R) Database Products
contained within such Modifications to any third party without the
prior written approval of Incyte.
(d) Except as expressly set forth herein, or as otherwise agreed
by Incyte in writing, diaDexus shall not reproduce, adapt, modify,
prepare derivative works based upon or distribute copies (in
whatever form whether tangible or intangible, by any means
whatsoever whether now known or hereafter invented) of the
LifeSeq(R) Database Product(s), including any substantial portion
of the Database Information from any field of the LifeSeq(R)
Database Product(s).
2.2.4 Designated Gene Product(s). During the Access Term and pursuant to
the escrow agreement, diaDexus shall make a deposit into escrow of
the identity of each Gene Product in Use or Used by diaDexus in the
conduct of research and development or other such use of a Gene
Product in accordance with the terms and conditions of this
Agreement.
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2.2.5 Records. diaDexus shall maintain records of access to and use of the
LifeSeq(R) Database Product(s) and the Database Information, reasonably
sufficient to enable diaDexus and Incyte to determine, and monitor
compliance with, their respective rights and obligations under this
Agreement (e.g., laboratory notebooks and such other records as are
customary for documenting research and product development activities).
No more than once a year unless as otherwise agreed in writing, at the
request and the expense of Incyte, upon at least forty-five (45) days'
prior notice, diaDexus shall permit an agent (not on a commission basis)
appointed by Incyte and acceptable to diaDexus to examine these records
solely to the extent necessary to verify the fulfillment of diaDexus'
obligations under this Agreement, provided that such agent has entered
into a confidentiality agreement with diaDexus reasonably satisfactory
to diaDexus and subject to diaDexus' security procedures. Incyte's agent
shall only report to Incyte the results of such examination (i.e.,
whether or not diaDexus is in compliance with its obligations under this
Agreement), and shall not disclose to Incyte any of diaDexus'
Confidential Information provided to it or to which it may have access
during the conduct of the examination.
2.2.6 Loss, Theft, Unauthorized Disclosure or Use. diaDexus shall promptly
notify Incyte of any loss, theft or unauthorized disclosure or use of
the LifeSeq(R) Database Product(s) or the Database Information which
comes to diaDexus' attention.
2.2.7 Termination of the Access Term. Upon termination or expiration of the
Access Term with respect to the applicable LifeSeq(R) Database
Product(s), diaDexus, at its election:
(a) shall have the option of extending the term of such LifeSeq(R)
Database Product(s) subscription or individual database module thereof
under terms demonstrably consistent with, and comparable to, those
secured by comparable users of the LifeSeq(R) Database Product(s) at the
time of extension; or
(b) shall discontinue use of such LifeSeq(R) Database Product(s) and
Database Information, and remove such LifeSeq(R) Database Product(s)
from the Installation Site, and promptly return to Incyte, or upon
Incyte's written instruction destroy, all portions and copies of such
LifeSeq(R) Database Product(s) and the Database Information; except for
that certain Database Information specific to Designated Gene Product(s)
which are the subject of one or more of the licenses granted to diaDexus
under Article 3.0 and/or extended pursuant to Section 7.2 below.
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Upon expiration of the Access Term (and any extension thereto),
diaDexus agrees to perform with Incyte a mutually acceptable
final accounting of those Designated Gene Product(s) which are
subject to one or more of the licenses granted to diaDexus under
Article 3.0 below.
2.2.8 Notification of Clinical Development. diaDexus agrees to keep
Incyte reasonably informed of all Product(s) resulting from the
use of the LifeSeq(R) Database Product(s), including notification
when a given Product candidate has been designated for clinical
development according to appropriate diaDexus procedures. All
information provided by diaDexus to Incyte pursuant to this
Section 2.3.8 shall be treated as diaDexus' Confidential
Information.
2.2.9 Reagents. Until September 2, 2005, upon request, diaDexus shall
provide to Incyte, as may be reasonably available to it, research
reagents developed by or on behalf of diaDexus from the use of
Incyte Technology. Incyte shall reimburse diaDexus for the actual
costs of producing such reagents.
3.0 LICENSE AND OPTION GRANTS
3.1 Non-Exclusive Licenses Under Incyte Technology for Research Field of Use
and Drug Product(s). Incyte hereby grants to diaDexus a worldwide,
non-exclusive license (with a right to sublicense as provided in Section
3.6) under Incyte Technology to conduct research in the Research Field of
Use and with respect to Designated Gene Product(s) to discover, develop,
make, have made, use, offer to sell, sell, import, export and distribute
Drug Product(s) in the Therapeutic Field of Use; provided however, that
with respect to the Research Field of Use, such grant does not include the
right to sell Gene Product(s). The term of such license under this Section
is subject to Section 7.2. Upon diaDexus' achievement of the milestones set
forth in Section 4.2 and the accompanying Table 4.2, diaDexus shall pay to
Incyte the applicable fees.
3.2 Non-Exclusive Know-How License - Diagnostic, Antisense, and Therapeutic
Protein Products. Incyte hereby grants to diaDexus a worldwide,
non-exclusive license (with a right to sublicense as provided in Section
3.6) under Incyte Know-How with respect to Designated Gene Product(s) to
discover, develop, make, have made, use, offer to sell, sell, import,
export and distribute Diagnostic Product(s) in the Diagnostic Field of Use,
and/or Antisense Product(s) in the Antisense Field of Use, and/or
Therapeutic Protein Product(s) in the Therapeutic Field of Use. The term of
such license is subject to Section 7.2. Upon diaDexus' achievement of the
milestones set forth in Section 4.2 and the accompanying Table 4.2,
diaDexus shall pay to Incyte the applicable fees.
Page 14 of 43
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3.3 Non-Exclusive License under Incyte Patents in the Diagnostics Field of Use.
During the Access Term and upon Incyte's receipt of: (i) written notice of
election to license a Designated Gene Product under Incyte Know-How or
Patent Rights, Incyte grants to diaDexus a worldwide, non-exclusive license
(with the right to sublicense as provided in Section 3.6), under Incyte
Patent Rights covering such Designated Gene Product to discover, develop,
make, have made, use, sell and import Diagnostic Product(s) in the
Diagnostics Field of Use. The grant and term of all licenses granted under
this Section 3.3 are subject to Section 7.2.
3.4 Option to Exclusive Patent License(s) - Therapeutic Field of Use, LifeSeq
Gold.
3.4.1 Therapeutic Protein Product(s).
(a) Option Grant. With respect to each Designated Gene Product
which diaDexus identifies pursuant to Section 3.4.1(b) and pays
the applicable option fee to Incyte pursuant to Section 3.4.1(c),
and subject to the provisions of Section 3.5, Incyte hereby
grants to diaDexus an option, exercisable by diaDexus at any time
during the applicable option period, to obtain a perpetual,
world-wide, exclusive license under the Incyte Patent Rights
covering the Designated Gene Product or the use of such
Designated Gene Product to discover, develop, make, have made,
use, offer to sell, sell, import, export and distribute
Therapeutic Protein Product(s) in the Therapeutic Field of Use
(the "Therapeutic Option"). Notwithstanding the foregoing, not
more than twenty (20) Designated Gene Product(s) shall be subject
to a Therapeutic Option at any one time.
(b) Option Notice. Subject to the provisions of Section 3.5,
prior to the expiration of the Access Term, diaDexus may identify
each designated Gene Product from the LifeSeq(R) Gold database
which shall be subject to the Therapeutic Option solely by giving
Incyte express written notice specifying such Designated Gene
Product.
(c) Option Fee. With respect to each Designated Gene Product
within the LifeSeq(R) Database Product(s), (i) the, "Therapeutic
Option Fee" shall be ****** ,
(ii) the option period shall be three (3) months from the date of
written notice by diaDexus to Incyte specifying that such
Designated Gene Product shall be subject to the Therapeutic
Option and (iii) diaDexus may extend the Therapeutic Option for a
given Designated Gene Product for up to three (3) additional
three-month periods at the same Therapeutic Option Fee, by
providing Incyte ten (10) business days written notice of such
extension, accompanied by payment of the Therapeutic Option Fee,
prior to the expiration of then-current three-month option
period.
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
Page 15 of 43
16
(d) License Exercise and Grant. Subject to the provisions of
Section 3.5, diaDexus may exercise the Therapeutic Option with
respect to any Designated Gene Product which is subject to a
Therapeutic Option solely by giving Incyte express notice of
exercise, specifying such Designated Gene Product to which the
license shall apply, and by paying to Incyte a license fee of
****** prior to the expiration of the applicable
option period. Upon Incyte's timely receipt of notice of
diaDexus' exercise and payment of the applicable license fee with
respect to such Designated Gene Product, and subject to the
provisions of Section 3.5, Incyte thereby grant to diaDexus a
perpetual, world-wide, exclusive license, with a right to
sublicense, under the Incyte Patent Rights covering such
Designated Gene Product or the use of such Designated Gene
Product to discover, develop, make, have made, use, offer to
sell, sell, import, export and distribute such Designated Gene
Product as a Therapeutic Protein Product(s) in the Therapeutic
Field of Use. Any such sublicense shall be in writing and shall
impose obligations on the sublicense that are consistent with
those applicable to diaDexus under this Agreement. The grant and
term of such license is subject to Section 7.2.
3.4.2 Antisense Field of Use.
(a) Option Grant. With respect to each Designated Gene Product
from the LifeSeq(R) Gold database which diaDexus identifies
pursuant to Section 3.4.2(b) and for which it pays the applicable
option fee to Incyte pursuant to Section 3.4.2(c) and subject to
the provisions of Section 3.5, Incyte hereby grants to diaDexus
an option, exercisable by diaDexus at any time during the
applicable option period, to obtain a perpetual, world-wide
exclusive license under the Incyte Patent Rights covering the
Designated Gene Product or the use of the Designated Gene Product
to discover, develop, make, have made, use, offer to sell, sell,
import, export and distribute Antisense Product(s) in the
Antisense Field of Use (the "Antisense Option"). Notwithstanding
the foregoing, not more than twenty (20) Designated Gene
Product(s) shall be subject to an Antisense Option at any one
time.
(b) Option Notice. Subject to the provisions of Section 3.5,
prior to the expiration of the Access Term, diaDexus may identify
each Designated Gene Product which shall be subject to the
Antisense Option solely by giving Incyte express written notice
specifying such Designated Gene Product.
(c) Option Fee. With respect to each Designated Gene Product
within the LifeSeq(R) Database Product(s), the Antisense Option
Fee shall be ****** , and the option period
shall be one (1) year from the date of written notice specifying
that such Designated Gene Product shall be subject to the
Antisense Option.
(d) License Exercise and Grant. Subject to the provisions of
Section 3.5,
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
Page 16 of 43
17
diaDexus may exercise the Antisense Option with respect to any
Designated Gene Product which is subject to an Antisense Option
solely by giving Incyte express notice of exercise, specifying such
Designated Gene Product to which the license shall apply, and by
paying to Incyte a license fee of ****** prior to the expiration of
the applicable option period. Upon Incyte's timely receipt of notice
of diaDexus' exercise and payment of the applicable license fee with
respect to such Designated Gene Product, and subject to provisions of
Section 3.5, Incyte thereby shall grant to diaDexus a perpetual,
world-wide, exclusive license, with a right to sublicense, under the
Incyte Patent Rights covering such Designated Gene Product to
discover, develop, make, have made, use, offer to sell, sell, import,
export and distribute such Designated Gene Product as an Antisense
Product(s) in the Antisense Field of Use. Any such sublicense shall be
in writing and shall impose obligations on the sublicensee that are
consistent with those applicable to diaDexus under this Agreement. The
grant and term of such license is subject to Section 7.2.
3.4.3 Development Obligations. diaDexus agrees to use reasonable diligent
efforts to pursue the development, Regulatory Approval and commercial
exploitation of Product(s) pursuant to any exclusive license granted
by Incyte hereunder with respect to a Designated Gene Product.
diaDexus' efforts shall be consistent with that applied by diaDexus
towards its other products with similar commercial potential, value,
and status. If diaDexus fails, abandons or suspends the development or
commercialization (including reasonable efforts to sublicense) of any
Product(s) with respect to any Designated Gene Product under an
exclusive license as provided in Section 3.4.1 or 3.4.2, then Incyte
shall have the right, in its sole discretion to terminate the
respective exclusive license upon writing notice to diaDexus. In the
event of such termination, diaDexus shall grant Incyte a perpetual
worldwide, exclusive license to all diaDexus know-how and interest in
such Designated Gene Product(s) (including those of diaDexus
Affiliate). However, Incyte, its licensee or assignee (as the case may
be) shall be obligated to make the royalty payments set forth in
Section 4.2, as applicable to exclusive Therapeutic License or
exclusive Antisense License, to diaDexus in the same manner as
diaDexus would have paid to Incyte.
3.4.4 Notwithstanding anything to the contrary herein, with respect to the
PathoSeq(TM) database, Incyte grants diaDexus no rights under Incyte
Technology to diaDexus to obtain any exclusive licenses or any
Therapeutic Options under this Agreement.
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
Page 17 of 43
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3.5 Limitations on Patent Licenses
3.5.1 Reservation of Rights
(a) For any Designated Gene Product which is the subject of an
exclusive option or exclusive license in the Therapeutic Field of Use
or Antisense Field of Use under Section 3.4, Incyte shall use prompt
and diligent efforts to make an annotation in the LifeSeq(R)
Database Product(s) regarding such exclusive option or exclusive
license, without specifying the identity of the licensee.
(b) Incyte reserves the right under the Incyte Technology (i) to
satisfy its obligations under this Agreement, (ii) to discover,
develop, make, have made, use and sell Gene Products and Products in
all fields of use outside the scope of an exclusive patent option or
an exclusive patent license granted to diaDexus under Section 3.4
above, and (iii) to grant licenses to third parties to discover,
develop, make and use and sell Gene Products, and Products in all
fields of use outside the scope of an exclusive patent option or an
exclusive patent license granted to diaDexus under Section 3.4 above.
(c) With respect to any proprietary cDNA Clone provided to diaDexus
under Section 3.4 above, Incyte reserves the right under the Incyte
Technology at any time to (a) release such cDNA Clone to an Incyte
database made available to subscribers by Incyte on a nonexclusive
basis, and/or (b) to provide such cDNA Clone to any third party;
provided, however, that such cDNA Clone is provided to a third party
under a license grant which is outside the scope of the exclusive
patent option or the exclusive patent license granted to diaDexus
under Section 3.5 above.
3.5.2 Third Party Obligations. It is understood by diaDexus that exclusive
option(s) and/or exclusive license(s) are offered to all LifeSeq
subscribers on a 'first-come, first-served' basis.
Page 18 of 43
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3.5.3 Incyte's Right to Unlicensed Gene Products. Notwithstanding anything
to the contrary in this Agreement, with respect to Gene Product for
which Incyte has applied for and obtained issued or granted claim(s)
under Incyte Patent Rights, LifeSeq subscribers such as diaDexus have
the right to acquire exclusive license to such Gene Products under
the provisions of Section 3.4 herein; provided, however, that (i) as
early as six (6) months following the date of issuance of such patent
claim(s), but (ii) in no event less than twelve (12) months following
the commencement of the Access Term (except that such 12-month period
shall not apply to any such patent claim(s) that have been issued for
more than three (3) years), Incyte may, in its discretion, elect by
written notice to diaDexus, to retain exclusive rights under Incyte
Patent Rights for the commercial development of Therapeutic Protein
Products in the Therapeutic Field of Use and/or for Antisense Products
in the Antisense Field of Use which diaDexus shall not have, prior to
such written notice, obtained an exclusive option or exclusive
license to such Incyte Patent Rights for the Therapeutic Field of Use
of Antisense Field of Use, as applicable. In no event, however, shall
this Section 3.5.3 limit diaDexus' non-exclusive rights to do
research and develop and commercialize Drug Products and Diagnostic
Products under Sections 3.1, 3.2 and 3.3 of this Agreement.
3.6 Sublicensing: The parties agree that brokerage of Database
Information or Incyte Technology by diaDexus is not permitted.
Therefore:
(a) Incyte explicitly withholds from this Agreement the right by
diaDexus to use or offer to use LifeSeq(R) Database Product(s) or
Database Information or any portion thereof, in any relationship with
a third party that (i) is focused solely on the use and interpretation
of the LifeSeq(R) Database Product(s) or Database Information and/or
(ii) consists of the provision by diaDexus of a database of DNA
sequence information to a third party under arrangements comparable in
nature to those embodied in this Agreement. diaDexus shall, however,
be permitted to use LifeSeq(R) Database Product(s) and Database
Information for corporate research and development collaborations with
a LifeSeq(R) Subscriber, only for as long as such collaborator is a
LifeSeq Subscriber.
Page 19 of 43
20
(b) Sublicensing of Drug Product(s), Antisense Product(s), and
Therapeutic Protein Product(s). On an individual Drug
Product-by-Drug Product, Antisense Product by Antisense Product basis
and Therapeutic Protein by Therapeutic Protein Product basis,
diaDexus may only license to a LifeSeq Subscriber, except as
otherwise provided in 3.4.1(d) and 3.4.2(d) with respect to exclusive
licenses granted the rights to such Product(s) developed by diaDexus.
diaDexus shall be responsible for all payments and royalties due to
Incyte under Article 4.0 hereunder for such sublicense, except the
Lead Development payment, for such Product, after such Product has
been licensed to a LifeSeq Subscriber.
(c) Sublicensing Diagnostic Product(s) to Third Parties. Subject to
the provisions of Section 5.2, on an individual Diagnostic
Product-by-Diagnostic Product basis, diaDexus may sublicense,
(without the right to further sublicense) to any third party, the
rights to Designated Gene Product(s) and the Incyte Database
Technology relating thereto, on a non-exclusive basis, in order to
develop, make, use, offer to sell, import, export and distribute such
Diagnostic Products granted under this Article 3.0; provided,
however, that without the prior written consent of Incyte, no
sublicense of Incyte Technology will be granted to any third party in
the absence of a corresponding license of rights to a given
Diagnostic Product discovered, researched and under bona fide product
development by diaDexus, and the license of patent rights pertaining
thereto owned by, licensed to or controlled by diaDexus; and further
provided that each sublicense has a grant which is consistent with
the terms herein and diaDexus shall be responsible for payments and
royalties under such sublicenses due to Incyte under Article 4.0
pursuant to the terms and conditions of this Agreement.
Page 20 of 43
21
3.7 Supply of cDNA Clones. Upon the written request of diaDexus and subject to
the grant of license rights as described in Section 3.1 and 3.2, Incyte
shall provide to diaDexus, one or more isolated cDNA Clones from the
LifeSeq(R) Database Product(s) under the following terms and conditions:
Shipments usually occur within twelve (12) business days of the receipt of
the order. For this service, a fee of ***** per verified clone will be
payable in cases where Incyte has on hand a previously-verified clone, or
in cases where diaDexus agrees to accept an alternate clone that Incyte has
previously verified. If Incyte does not have on hand a previously-verified
clone requested by diaDexus, diaDexus may request that Incyte attempt to
sequence and verify a clone, at a cost of ***** per clone, provided that
although Incyte shall use professional skill and care in its efforts, the
results of any such attempt to sequence and verify a clone in that case
will be provided on an "AS IS" basis. diaDexus agrees to submit any
payments due within thirty (30) days from receipt of invoice from Incyte in
reasonably detailed form regarding such clone supply.
diaDexus agrees that such cDNA Clone(s) are provided to diaDexus on a
nonexclusive basis and subject to any license(s) granted under Article 3.0.
3.8 No rights to use any Database Information or Incyte Technology for genetic
analyses of differences among individuals which are single nucleotide
polymorphisms (SNPs).
4.0 SCHEDULE OF PAYMENTS; ROYALTIES
4.1 Service Fee(s).
During the first year of the Access Term, Incyte agrees to provide diaDexus
with library construction, microarray and sequencing services under
Incyte's commercial terms and conditions for comparable services. diaDexus
agrees to pay the balance of the original Five Million Dollars ($5,000,000)
in the Collaboration Agreement for sequencing services, which shall be
payable in arrears in four (4), three (3) month installments each payable
prior to the last day of each calendar quarter, the first such quarter
ending on March 31, 2000. Any portion of said balance remaining unapplied
at the end of each three (3) month installment shall be forfeited by
diaDexus and shall become the property of Incyte. In addition, such fees
are non-refundable, non-cancelable, non-creditable, except as provided
herein, and are not subject to any carry over to any other agreement
between diaDexus and Incyte.
4.2 Milestone Payments and Royalties. Contingent on the following events, and
subject to Sections 4.6 and 4.7, the additional payments and royalties
listed in Table 4.2 shall be paid by diaDexus (within thirty (30) days of
such event) to Incyte for each Product(s).
Table 4.2
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
Page 21 of 43
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Non-Exclusive Non-Exclusive
License(s) License(s)
under Incyte under Incyte
Non-Exclusive Know-How - Know-How or Exclusive Exclusive
License(s) Therapeutic Incyte Patent Therapeutic Antisense
under Incyte Protein & Rights - License(s) License(s)
Technology - Antisense Diagnostic under Incyte under Incyte
Drug Products Products Product Patent Rights Patent Rights
(Section 3.1) (Section 3.2) (Sections 3.2, 3.3) (Section 3.4.1) (Section 3.4.2)
------------------------------------------------------------------------------------------------------------------------
Gene Product ***** ***** none ***** *****
License Fee
See in (a)
below.
------------------------------------------------------------------------------------------------------------------------
Option Fee ***** for one ***** for one
under Incyte three month year
Patent Rights period.
for exclusivity renewable up to
3 times
------------------------------------------------------------------------------------------------------------------------
License Fee none ***** *****
under Incyte
Patent Rights
------------------------------------------------------------------------------------------------------------------------
Lead ***** ***** ***** *****
Development
Payment;
See fn.'s (b)
& (f) below
------------------------------------------------------------------------------------------------------------------------
IND ***** ***** none ***** *****
(or equivalent)
filing payment;
see fn.'s (c),
(f) and (i)
below
------------------------------------------------------------------------------------------------------------------------
Phase III ***** ***** ***** *****
Clinical Trials
Payment;
See fn.'s (d)
& (f) below
------------------------------------------------------------------------------------------------------------------------
Regulatory ***** ***** none ***** *****
Approval
Payment;
See fn.'s (e)
& (f) below
------------------------------------------------------------------------------------------------------------------------
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
Page 22 of 43
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Non-Exclusive Non-Exclusive
License(s) License(s)
under Incyte under Incyte
Non-Exclusive Know-How- Know-How or Exclusive Exclusive
License(s) Therapeutic Incyte Patent Therapeutic Antisense
under Incyte Protein & Rights - License(s) License(s)
Technology - Antisense Diagnostic under Incyte under Incyte
Drug Products Products Product Patent Rights Patent Rights
(Section 3.1) (Section 3.2) (Sections 3.2, 3.3) (Section 3.4.1) (Section 3.4.2)
----------------------------------------------------------------------------------------------------------------------------
Royalties on Net Sales ***** ***** ***** ***** *****
----------------------------------------------------------------------------------------------------------------------------
Notes: All fees, payments and royalties are to be made in United States dollars.
(a) Paid within thirty (30) days of achieving Product Development Milestone.
(b) Paid within thirty (30) days of taking Product into Lead/Product
Development on a Gene Product-by-Gene Product basis for each Product that
is taken into Lead/Product Development.
(c) Paid within thirty (30) days after the filing of the first investigative
New Drug application ("IND") with the United States Food and Drug
Administration ("FDA") or foreign equivalent by diaDexus or a diaDexus
sublicensee with respect to each given Product.
(d) Paid within thirty (30) days after the first initiation of Phase III
Clinical Trials by diaDexus or a diaDexus sublicensee with respect to
each given Product.
(e) Paid within thirty (30) days after the first Regulatory Approval granted
to diaDexus or a diaDexus sublicensee for each given Product.
(f) Single Payment Obligation. Each of the above milestone payments shall be
payable once with respect to Products relating to a given Designated Gene
Product, upon the first occurrence of the indicated milestone for such
Product, and no additional payments shall be due upon subsequent or
repeated achievement of the same milestone for a different Product in the
same Field of Use under the same Designated Gene Product license. For
example, if diaDexus or its sublicensee develops two Drug Products
relating to the same Designated Gene Product and both such Drug Products
achieve a given
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
Page 23 of 43
24
milestone, the applicable payment will only be made once upon the first
such occurrence. Notwithstanding the foregoing, Diagnostic Products shall
be subject to Section 3.3
(g) The above % of Net Sales royalty will be paid with respect to each
Product in each given country where, but for the patent license(s)
granted herein, such sales would otherwise infringe a Valid Claim of the
Incyte Patent Rights.
4.3 Payment Obligation. The foregoing payments under Section 4.2 will accrue
or become due or payable with respect to Drug Product(s), Antisense
Product(s), Therapeutic Protein Product(s), and/or Diagnostic Product(s)
which are:
(a) materially based on or use materially or are derived by material
use of that which would constitute Incyte Know-How at the time of Use By
diaDexus; or
(b) are covered by a Valid Claim of Incyte Patent Rights and/or which
Product is identified or discovered by a drug discovery process (e.g.
compound screening) which utilizes a Gene Product which is covered by a
Valid Claim of Incyte Patent Rights.
If a Product would be covered by more than one of the licenses referred
to in Section 4.2 (e.g., where an IND is filed with respect to a Product
that is covered by two or more of the licenses granted to diaDexus under
Section 3.1 through 3.4), only the largest of the milestone payments or
royalties called for in such applicable Sections shall be payable, and
there will be no multiple royalties due under such Section 4.2.
4.4 Duration of Payment Obligation. Royalty obligations with respect to each
Product under any portion of this Article 4.0 shall terminate on a
country-by-country and product-by-product basis on the later of (i) ten
(10) years after the first country-wide launch of each Product in each
country or (ii) expiration of the last-to-expire Valid Claim which covers
such product in each country.
Upon termination of the royalty payment obligation, diaDexus shall
thereafter have in perpetuity a royalty-free license to make, use and
sell such Product in the specified field(s) of use without any accounting
to Incyte.
Page 24 of 43
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4.5 Mode of Payment. For purposes of determining when a sale of a
royalty-bearing Product occurs, the sale shall be deemed to occur on the
date of the invoice to the purchaser of the Product. All royalty payments
shall be made within ninety (90) days of the end of each calendar quarter
in which the sale was made. Any royalty payment that is not paid on or
before the date such payment is due under this Agreement shall bear
interest to the extent permitted by applicable law, at two percentage
points over the prime rate of interest as reported by Bank of America NT&SA
in San Francisco, California, from time to time, calculated on the number
of days such payment is delinquent. Royalties shall be deemed payable by
the entity making the Net Sales from the country in which earned in local
currency and subject to foreign exchange regulations then prevailing.
Royalty payments shall be made to Incyte in United Sates dollars. The rate
of exchange to be used in any such conversion from the currency in the
country where such Net Sales are made shall be the rate of exchange used by
diaDexus for reporting such sales for United States financial statement
purposes.
4.6 Records Retention. diaDexus agrees to keep for at least three (3) years
records of all sales of Products in sufficient detail to permit Incyte to
confirm the accuracy of diaDexus' royalty calculations. Once a year, at the
request and the expense of Incyte, upon at least forty-five (45) days'
prior written notice, diaDexus shall permit a nationally recognized,
independent, certified public accountant appointed by Incyte and acceptable
to diaDexus, to examine these records solely to the extent necessary to
verify such calculations, provided that such accountant has entered into a
confidentiality agreement with diaDexus substantially similar to the
confidentiality provisions of this agreement, limiting the use and
disclosure of such information to purposes germane hereto. The examination
shall be limited to pertinent books and records for any year ending not
more than twenty-four (24) months prior to the date of such request.
diaDexus may designate competitively sensitive information which such
auditor may not disclose to Incyte, provided, however, that such
designation shall not encompass the auditor's conclusions. The accounting
firm shall disclose to Incyte only whether the royalty reports are correct
or incorrect and the specific details concerning any discrepancies. No
other information shall be provided to Incyte. If such accounting firm
correctly concludes that there was an underpayment of royalties by five
percent (5%) or more, diaDexus shall pay all costs of such examination. If
such accounting firm concludes that additional royalties were owned, the
additional royalties shall be paid within thirty (30) days of the date
Incyte delivers to diaDexus such accountant's written report so concluding.
Any overpayments by diaDexus will at diaDexus' option be credited against
future royalty obligations or paid to diaDexus within ten (10) days of
discovery of such overpayment. This Section shall survive the cessation of
payment obligations under Section 4.3 for a period of two (2) years.
Page 25 of 43
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4.7 Shipping. diaDexus shall pay, for its own account, any shipping, freight,
mailing expenses and the like payable to third parties not affiliated with
Incyte and arising out of obtaining tangible materials under this Agreement
and the transactions contemplated herein.
4.8 Payments and Taxes. Unless otherwise provided in this Agreement, diaDexus
agrees to submit payments for services and materials provided by Incyte
within thirty (30) days from receipt of invoice. All payments hereunder
shall be made by bank wire transfer in immediately available funds to such
account as Incyte shall designate in writing from time to time. All
payments by diaDexus to Incyte under this Agreement shall be paid from a
diaDexus account in a banking institution located in the United States.
diaDexus shall pay, or reimburse Incyte, as appropriate, and indemnify
Incyte against any sales, use, value added/ad valorem, surtax and personal
property taxes, customs duties, registration fees and the like arising out
of the provision of services and materials by Incyte to diaDexus under this
Agreement. All turnover taxes, income taxes, gross revenues and profits
taxes, and other taxes based on Incyte's income (other than those covered
by the preceding sentence) levied on account of the royalties, milestone
payments, license fees and other payments accruing to Incyte under this
Agreement shall be paid by Incyte.
If at any time, any jurisdiction within the given country requires the
withholding of income taxes or other taxes imposed upon royalty payments
set forth in this Article 4, diaDexus shall make such withholding payments
as required and subtract such withholding payments from the royalty
payments set forth in this Article 4, or if applicable, Incyte will
promptly reimburse diaDexus or its designee(s) of the amount of such
payments. diaDexus shall provide Incyte with documentation of such
withholding and payment in a manner that is satisfactory for purposes of
the U.S. Internal Revenue Service. They payments to be made by diaDexus
under Section 4.1 include amounts attributable to such items as training
manuals and the electronic media used for data transfer (e.g.; CD's).
Payments attributable to such items and the clone transfer fees provided
for under Section 3.7 are or may be subject to sales tax.
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5.0 CONFIDENTIALITY AND PUBLICATION
5.1 Confidentiality. The Parties acknowledge that during the course of this
Agreement they will each receive from the other information which is
proprietary, confidential and of commercial value to the disclosing party.
For purposes of this Agreement, "Confidential Information" shall mean
scientific, technical or business information belonging to the disclosing
party, which the disclosing party marks "Confidential" if disclosed in
writing, or which the disclosing party identifies as confidential at the
time of any visual or oral disclosure and promptly confirms in writing to
have been confidential. Except to the extent expressly authorized by this
Agreement, the parties agree that, for the Access Term and for five (5)
years thereafter, except in the case of DNA sequence information, for which
such period shall be perpetual, the receiving party shall keep confidential
and shall not publish or otherwise disclose and shall not use for any
purpose (except those expressly permitted under this Agreement) any
Confidential Information furnished to it by the other party pursuant to
this Agreement, and regardless of the medium on which it is provided,
including know-how, except to the extent that it can be established by the
receiving party by competent proof that such information:
(a) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure by the other
party;
(b) was generally known to the public or otherwise part of the public
domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure other than through any act or omission
of the receiving party in breach of this Agreement;
(d) was subsequently lawfully disclosed to the receiving party by a third
party having no confidentiality obligations to the disclosing party with
respect thereto;
(e) was independently discovered or developed by the receiving party
without the use of the other party's Confidential Information, and such
independent discovery or development can be documented by the receiving
party's tangible records created at the time of such independent
development.
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Each party may disclose the others Confidential Information to the extent
such disclosure is reasonably necessary in (i) filing and prosecuting
patent applications, and maintaining patents, (ii) prosecuting or
defending litigation, (iii) responding to any properly served subpoena or
compulsory process requiring the disclosure of information to any
government entity however the disclosing party shall provide the party
whose information will be disclosed with as much notice as is commercially
reasonably practical to allow such other party with the opportunity to
quash such subpoena or compulsory process, or (iv) complying with
applicable governmental laws and regulations governing the testing,
approval, manufacture and marketing of Products; provided, however, that
prior to disclosure of the other party's Confidential Information it will
give reasonable advance notice to such party, will only disclose the
minimum Confidential Information necessary, and will use reasonable
efforts to secure confidential treatment of such Confidential Information.
It is understood that patent applications are filed with the expectation
and intention that such applications will, upon publication of the
applications and/or issuance of the resulting patents, result in the
publication or public accessibility of all information disclosed in the
underlying application and prosecution documents; provided, however, that
publication of such Information shall not affect either party's ongoing
obligations to the other party with respect to Information not so
disclosed.
5.2 Disclosure; Third Party Access. Except as provided for in Sections 2.3.4
and 3.6 above, Confidential Information of Incyte will not be published or
disclosed in any form without the written authorization of Incyte.
(a) diaDexus and diaDexus' sublicensees may publish their own scientific
results and the conduct of their work within the scope of the licenses
granted under this Agreement, provided, however, that:
(i) any such publication by diaDexus or its sublicensees that would
disclose Confidential Information of Incyte shall require the prior written
consent of Incyte, which consent will not be unreasonably withheld or
delayed provided that diaDexus has taken necessary steps to provide for
diligent review by Incyte for removal of, or approval to disclose, Incyte
Confidential Information. In no event shall Incyte's review be delayed
beyond forty five (45) business days of diaDexus' request for review; and
(ii) such disclosure is on an individual Designated Gene Product-by
Designated Gene Product-basis and reflects research results which have
involved material investment above and beyond Database Information; and
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(iii) a deposit in escrow has been made prior to disclosure in accordance
with the provisions of Section 2.3.4 and Exhibit A with respect to
Designated Gene Product(s) which are the subject of such Confidential
Information; and
(iv) diaDexus has taken diligent steps toward protection of
proprietary subject manner contained therein; and
(v) Incyte has had the reasonable opportunity (i.e.; not more than
forty five (45) days) to file patent applications for protection of the
subject matter that is proprietary to Incyte for Incyte Technology; and
(vi) any such publications will include recognition of the
contributions of Incyte according to standard practice for assigning
scientific credit, either through authorship or acknowledgment as may be
appropriate.
(b) Any scientific publications that would disclose Confidential
Information of Incyte on other than an individual Designated Gene Product
by Gene Product basis shall be under reasonable terms and conditions
mutually agreed between the Parties, including the provisions of
subparagraphs 5.2(a)(i) to (vi) above.
5.3 Confidential Disclosure to Third Party Collaborators. Incyte recognizes
that diaDexus, in the normal course of business, utilizes consultants and
academic collaborators who are bound by a contractual obligation to
diaDexus, including an obligation of confidentiality to diaDexus. diaDexus
may disclose Confidential Information of Incyte to such consultants and
academic and third party collaborators in the context of the disclosure of
diaDexus' own scientific results or the conduct of its work within the
scope of the licenses granted herein provided, however, that:
(a) (i) diaDexus has obtained a written obligation of confidentiality and
appropriate use restrictions (including field of use) no less restrictive
than those set forth herein and provided that such third party shall not
further disclose Confidential Information; and
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(ii) any such disclosure of Confidential Information which includes the
transfer of DNA Sequence Information or biological materials shall be
subject to a written materials transfer agreement which protects the
intellectual property rights of Incyte and diaDexus as set forth herein,
such agreement to include customary provisions regarding scope of work,
publication (under terms no less restrictive that those set forth herein),
protection of proprietary subject matter and ownership of inventions; and
the following provisions: that the third party shall use such biological
materials and DNA Sequence Information for the benefit of diaDexus and/or
sublicensees; and that Incyte proprietary DNA Sequence Information remains
the sole and exclusive property of Incyte. Other customary provisions
including, but not limited to, scope of work, publication, ownership of
inventions, provisions regarding ownership of the biological materials
and/or DNA Sequence Information and any derivatives.
Such agreement will be in a form substantially similar to the agreements
that diaDexus utilizes to protect is own biological materials; and
(iii) a deposit in escrow has been made prior to disclosure in
accordance with the provisions of Section 2.2.4 and Exhibit A with respect
to Designated Gene Product(s) which are the subject of such Confidential
Information and;
(iv) diaDexus has obtained a written obligation from such third party
regarding Incyte's right to review publications as under the provisions of
Section 5.2(a) herein.
The foregoing provisions of Section 5.2 and 5.3 shall not apply to any
exclusive licenses diaDexus hold for Therapeutic Protein Products or
Antisense Products pursuant to Section 3.4.
Incyte agrees that Confidential Information of diaDexus will not be
published or disclosed in any form except as permitted by Section 5.1.
5.4 Except as permitted pursuant to Section 5.1, this Article 5.0 shall not be
construed to allow diaDexus and its sublicensees to publish or disclose the
contents of LifeSeq(R) Database Product(s) or any Incyte software or
hardware configurations, at any time without the express written consent of
Incyte.
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6.0 INTELLECTUAL PROPERTY
6.1 Incyte Rights. With the exception of intellectual property rights granted
to diaDexus under the nonexclusive or exclusive license(s) granted under
this Agreement, Incyte retains all rights it has to the Incyte Technology,
LifeSeq(R) Database Product(s), and Database Information (including Full
Length Clones or Full Length Contigs provided to diaDexus by Incyte) and
the LifeSeq(R) Database Product(s) (collectively, "Incyte Inventions") and
no licenses are granted herein except for those expressly provided in
Article 3.0.
diaDexus Rights. Except as otherwise provided herein, diaDexus, licensees,
or sublicensees, as applicable, shall respectively own all inventions
conceived, discovered or developed by diaDexus, licensees, or sublicensees
in connection with this Agreement including without limitation all
intellectual property rights and title in and to any partial cDNAs, genes,
full length cDNAs corresponding thereto, RNAs, peptides, polypeptides and
proteins encoded thereby, Product(s), Modifications made by diaDexus
excluding LifeSeq(R) Database Product(s) contained therein and inventions
relating thereto (collectively, "diaDexus Inventions").
6.2 Patent Prosecution
Incyte Inventions. Except as provided herein, the filing, prosecution,
maintenance, and enforcement of patent(s), copyrights, and other
proprietary rights that cover Incyte Inventions shall be the exclusive
right and responsibility of, and at the discretion of Incyte, provided that
in the event Incyte declines the option to diligently file, prosecute,
maintain or enforce any such proprietary rights under which diaDexus has
been granted an exclusive option or license, Incyte shall give diaDexus
reasonable notice to this effect and thereafter, diaDexus may, upon written
notice to Incyte, file and prosecute such applications and maintain such
intellectual property rights in Incyte's name, all at diaDexus' expense,
except that diaDexus may deduct any expenses so incurred from any payments
due to Incyte from diaDexus in connection with such exclusive option or
license.
diaDexus Inventions. Except as provided herein, the filing, prosecution,
maintenance and enforcement of patent(s), copyrights, and other proprietary
rights that cover diaDexus Inventions, shall be the exclusive right and
responsibility of, and at the discretion of diaDexus.
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Joint Inventions. The filing, prosecution, and maintenance of patent(s),
copyrights, and other proprietary rights and the expense of filing,
prosecuting and maintaining any patents, copyrights and other proprietary
rights conceived jointly by employees of both parties shall be the
exclusive right and responsibility of, and at the discretion of diaDexus;
provided that in the event diaDexus declines the option to file,
prosecute or maintain any such proprietary rights; diaDexus shall give
Incyte reasonable notice to this effect and thereafter, Incyte may, upon
written notice to diaDexus, file and prosecute such applications and
maintain such intellectual property rights in diaDexus' name, all at
Incyte's expense and all such intellectual property rights shall remain
owned jointly by the parties.
6.3 Cooperation. Each party agrees to cooperate with the other with respect
to the filing prosecution, maintenance and extension of patents and
patent applications, including without limitation, the execution of all
such documents and instruments and the performance of such acts as may be
reasonably necessary in order to permit the other party to continue any
filing, prosecution, maintenance or extension of patents and patent
applications that such party has elected not to pursue as provided for
above. With respect to a Gene Product under Non-Exclusive Patent License
in the Diagnostics Field of Use, and for the duration of such license,
patent costs, upon the mutual written agreement of the Parties, will be
shared equally by diaDexus, Incyte and any other Non-Exclusive
licensee(s).
With respect to a Gene Product under non-exclusive patent license in the
Diagnostics Field of Use, and for the duration of such license, patent
costs, upon the mutual written agreement of the parties, will be shared
equally by diaDexus, Incyte and any other non-exclusive licensee(s).
6.4 During the Access Term and/or any active option, diaDexus shall have the
right to inspect Incyte Patents Rights with respect to a given Designated
Gene Product, from time to time on Incyte's premises and on reasonable
notice for the purpose of evaluating diaDexus' interest in obtaining an
option or exclusive license under such Incyte Patent Rights. Upon
entering into an exclusive license to a Designated Gene Product and for
the duration of such license, patent costs including out-of-pocket costs
and cost of outside counsel relating to the filing, prosecution and
maintenance of Incyte Patent Rights directed to such Designated Gene
Product under exclusive license shall be the responsibility of and at the
expense of diaDexus, provided that in the event diaDexus declines the
option to file, prosecute or maintain any such proprietary rights,
diaDexus shall give Incyte reasonable notice to this effect and
thereafter, Incyte may, upon written notice to diaDexus, file and
prosecute such applications and maintain such intellectual property
rights in Incyte's name, at Incyte's expense.
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6.5 Research Tools and Database Products or Services. With respect to
composition of matter of use claims directed to Designated Gene Product(s)
owned or controlled by diaDexus and sublicensee(s), diaDexus and
sublicensee(s) agrees not to xxx or bring any action in any court or
administrative agency or any other government authority alleging
infringement of said patents as a result of activities of Incyte or its
affiliates or (sub)licensee(s) with respect to commercialization of
research tools or database products or services, including microarray-based
research tools or database products or services, by Incyte or its
affiliates or (sub)licensee(s), which would constitute an infringement of
said patents, and further, diaDexus and sublicensee(s) agrees to extend
such freedom from suit or action to further (sub)licensee(s) of Incyte, its
affiliates or licensees with respect to commercialization of research tools
or database products or services. Such freedom from suit does not extend to
"rDx Kits" or "rDx Services", as granted to diaDexus in the Diagnostics
Field of Use.
6.6 Freedom From Suit - Research. In the event diaDexus or its sublicensee(s)
develops technology directed to the use of Designated Gene Product(s) as
targets in the development of ligands of Gene Product(s) and said
technology, or aspects thereof, is ultimately claimed in patents owned or
controlled by diaDexus or its sublicensee(s), diaDexus or its
sublicensee(s) as the case may be) agrees not to xxx or bring any action in
any court or administrative agency or any other government authority
alleging infringement of said patents as a result of activities of Incyte
or its affiliates or (sub)licensee(s) in the Research Field of Use which
would constitute an infringement of said patents, and further, diaDexus or
its sublicensee(s) as the case may be) agrees to extend such freedom from
suit or action to further (sub)licensee(s) of Incyte, its affiliates,
licensees or other subscribers of LifeSeq(R) Database Product(s). The
foregoing freedom from suit provisions shall only apply with respect to
such parties which have executed an agreement which contains an active
provision with substantially similar rights to Incyte, its affiliates,
licensees and subscribers with respect to any similar patents rights of
said affiliates, (sub)licensee or subscriber.
6.7 Notwithstanding anything to the contrary in these Sections 6.5 and 6.6,
nothing in this Agreement shall limit diaDexus right to license diaDexus
intellectual property with regard to Diagnostic Products.
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6.8 Third Party Patents. Subject to the warranties made hereunder as to each
party's knowledge of any third party rights that may be infringed by the
uses of the Database Information as contemplated herein, the Parties
acknowledge that, in order to develop, and/or commercialize one or more
Gene Products, they may require license under third party patent rights or
such other rights, and it is hereby agreed that it shall be each Party's
responsibility to satisfy itself as to the need for such licenses and, if
necessary, to obtain such licenses. To the extent that diaDexus obtains
any such third party licenses, it shall have no obligation to grant any
sublicense or other rights to Incyte or to any third party with respect
thereto. To the extent that diaDexus or its sublicensees obtain subsequent
to the date of this Agreement licenses to third party patents or other
intellectual property that claim rights to the composition of matter of a
Gene Product, diaDexus may deduct such license fees and royalties from the
royalty on Net Sales due to Incyte but only up to an amount equal to fifty
percent (50%) of the royalty otherwise due hereunder for the same payment
period and only with respect to royalties payable on an exclusive
Therapeutic License or exclusive Antisence License under Incyte Patent
Rights for which diaDexus would otherwise be required under Table 4.2 to
pay a ***** royalty.
7.0 TERM; TERMINATION
7.1 Term: Termination at Full Term. This Agreement shall commence as of the
Effective Date and shall terminate as provided herein.
7.2 Term of License(s). Upon expiration of the Access Term the following
provisions shall apply.
(a) Except as provided below, all of the license(s) granted in the
Diagnostic Field of Use Under Sections 3.2 and 3.3 herein shall remain in
full force and effect after expiration of the Access Term provided that:
(i) DiaDexus has deposited such Designated Gene Product(s) into escrow
pursuant to Section 2.2.4 prior to termination or expiration of the Access
Term, (ii) diaDexus has complied with all of its obligations under Article
4.0 with respect to such license(s), and (iii) this Agreement has not been
terminated by Incyte pursuant to Paragraph 7.3 hereinbelow.
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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b) Prior to expiration, but not termination, of the Access Term, diaDexus
may retain any license that has been procured under Sections 3.1 and/or
3.2, (except in the Diagnostics Field of Use), on a Designated Gene
Product by Designated Gene Product basis, by paying to Incyte an annual
license maintenance fee of Fifteen Thousand Dollars ($15,000) until the
earlier of:
(i) The filing by diaDexus or a diaDexus sublicensee of an IND or foreign
equivalent in which case such license shall then extend in perpetuity; or
(ii) The license is terminated prior to the filing by diaDexus or a
diaDexus sublicensee of an IND (or BLA) or equivalent, on a given
anniversary of the Access Term.
7.3 Breach. Material failure by either party to comply with any of its
obligations under this Agreement shall entitle the other party to give to
the party in default notice specifying the nature of the default and
requiring it to cure such default. If such default is not cured within
ninety (90) days after the receipt of such notice, the notifying party
shall be entitled, without prejudice to any of its other rights conferred
on it by this Agreement, in addition to any other remedies available to it
by law or in equity, immediately to terminate this Agreement by giving
notice to the other party. The right of a party to terminate this
Agreement, as hereinafter provided, shall not be affected in any way by
its waiver or failure to take action with respect to any previous default.
7.4 Accrued Rights Surviving Obligations. Termination, relinquishment or
expiration of this Agreement for any reason shall be without prejudice to
any rights which shall have accrued to the benefit of either party prior
to such termination, or expiration. Upon any termination, relinquishment
or expiration of this Agreement, the following provisions will not
terminate, but will continue in full force and effect: Articles 5
(confidentiality), 6 (intellectual property), 8 (representations/
warranties), 9 (indemnity), 10 (miscellaneous) and Exhibit A (Escrow), and
any licenses or options entered, and any payment obligations thereunder
pursuant to diaDexus' rights under Articles 3 and 4.
8.0 REPRESENTATIONS AND WARRANTIES; COVENANTS
8.1 Representations and Warranties. Each party represents and warrants to the
other party that:
(a) it is a corporation or entity duly organized and validly existing
under the laws of the state or other jurisdiction of incorporation or
formation;
(b) it has the corporate power and authority and the legal right to enter
into this Agreement and to perform its obligations hereunder;
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(c) the execution and delivery of this Agreement and the performance by
such party of the transactions contemplated hereby have been duly
authorized by all necessary corporate action of such party; and
(d) except for the governmental and Regulatory Approvals required to
market the Product(s) in the given country, the execution, delivery and
performance of this Agreement by such party does not require the consent,
approval or authorization of, or notice, declaration, filing or
registration with, any governmental or regulatory authority and the
execution, delivery or performance of this Agreement by such party does
not violate any law, rule or regulation applicable to such party.
8.2 Incyte's Representations. Incyte hereby represents, warrants and covenants
to diaDexus as follows:
(a) to the best of Incyte's knowledge, as of the Effective Date it is the
owner, or licensee (with the right to grant sublicenses), of the Incyte
Patent Rights and Incyte Know-How, and no other person, corporate or other
private entity, or governmental entity or subdivision thereof, has or
shall have any claim of an ownership interest with respect to those Incyte
Patent Rights and Incyte Know-How owned by Incyte, whatsoever;
(b) Upon Incyte's receipt of notice of election to option or license a
Designated Gene Product under Incyte Patent Rights in the Diagnostic Field
of Use, Therapeutic Field of Use, or Antisense Field of Use, Incyte agrees
to notify diaDexus of any notice of infringement, claims, judgments or
settlements against or owed by Incyte, or any pending or threatened claims
or litigation, known to Incyte without undertaking a special
investigation, relating to such Incyte Patent Rights (collectively, the
"Infringement Notification". In the event of an Infringement Notification,
diaDexus shall have the option, in its sole discretion, to rescind its
notice of election;
(c) that (i) the LifeSeq(R) Database Products, will perform in accordance
with its documentation and shall have, at a minimum, the functionality
described in Exhibits B and C, (ii) that the LifeSeq(R) Database Products
do not contain any disabling device, code, computer virus or defect that
will with the passage of time or otherwise, impair the functionality or
use of the LifeSeq(R) Database Products, and (iii) that the LifeSeq(R)
Database Products shall not with respect to any date data which the
LifeSeq(R) Database Products use in any manner and any system date which
the LifeSeq(R) Database Products use as its current date, malfunction,
cease to function, generate incorrect date or produce incorrect results
and shall function with respect to leap year calculations. Further in
connection with providing date data to and accepting date data from other
automated computerized and/or software systems and users via user
interfaces, electronic interfaces and data storage, the LifeSeq(R)
Database Products represent dates without ambiguity as to century. In the
event the LifeSeq(R) Database Products are century noncompliant in any
respect, Incyte will at no cost to diaDexus within thirty (30) days correct
the noncompliance and provide the corrected compliant product to diaDexus.
Any such century noncompliance
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shall not constitute a force majeure; and
(d) Incyte has the legal right to license and/or sublicense to diaDexus,
all third party products set forth in Exhibit C and/or otherwise
delivered with the LifeSeq(R) Database Products.
For purposes of this Section 8.2, the term "to the best of Incyte's
knowledge" shall mean in each case Incyte's best knowledge without
undertaking any special investigation with respect to such subject
matter beyond the scope of those diligent investigations normally
performed by Incyte in the course of its own business operations.
8.3 No Conflicting Agreements. Neither party has in effect and after the
Effective Date neither party shall enter into any oral or written
agreement that would conflict with its obligations under this Agreement.
8.4 Compliance with Law. Each party shall be responsible for compliance with
all applicable product safety, product testing, product labeling,
package marking, and product advertising laws and regulations with
respect to its own activities and Products. Further, diaDexus and Incyte
shall each comply with the regulations of the United States and any
other relevant nation concerning any export or other transfer of
technology, services, or products. The Export Commodity Control Number
("ECCN") for both the LifeSeq(R) Gold Database, PathoSeq Database, and
the LifeTools(TM) Product is EAR 99.DBPROducts.
8.5 Disclaimers.
(a) EXCEPT AS EXPLICITLY STATED HEREIN, NOTHING IN THIS AGREEMENT
SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN
BY INCYTE THAT ANY PATENT WILL ISSUE BASED UPON ANY PENDING
PATENT APPLICATION WITHIN THE INCYTE PATENT RIGHTS, THAT ANY
PATENT WITHIN THE INCYTE PATENT RIGHTS THAT HAS ISSUED OR
ISSUES WILL BE VALID, OR THAT THE USE OF ANY LICENSE GRANTED
HEREUNDER OR THAT THE USE OF ANY INCYTE PATENT RIGHTS WILL
NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY THIRD
PARTY. INCYTE MAKES NO REPRESENTATIONS OR WARRANTIES WITH
RESPECT TO DIADEXUS' USE OF THE INFORMATION TO BE PROVIDED TO
IT HEREUNDER. EXCEPT AS EXPLICITLY STATED HEREIN, ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY, NOVELTY OR FITNESS OF GENE PRODUCTS OR
DATABASE INFORMATION FOR ANY PARTICULAR PURPOSE, ARE
EXCLUDED. INCYTE MAKES NO WARRANTY THAT THE DATABASE
INFORMATION DOES NOT CONTAIN ERRORS, HOWEVER INCYTE WARRANTS
THAT IT USED AND SHALL CONTINUE TO USE PROFESSIONAL SKILL AND
CARE IN THE CREATION,
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PREPARATION AND MAINTENANCE OF THE LifeSeq(R) Database Products.
(b) EXCEPT AS EXPLICITLY STATED HEREIN NEITHER PARTY WILL BE LIABLE
FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY NATURE ARISING
FROM SUCH PARTY'S ACTIVITIES UNDER THIS AGREEMENT; PROVIDED,
HOWEVER, THAT THIS LIMITATION SHALL NOT LIMIT THE INDEMNIFICATION
OBLIGATION OF SUCH PARTY UNDER SECTION 9.2 BELOW FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES RECOVERED BY A THIRD PARTY.
9.0 INDEMNITY
9.1 Indemnification by diaDexus. diaDexus shall indemnify, defend and hold
Incyte, its affiliates and licensees (other than Incyte) harmless from and
against any and all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) as the result of claims, demands,
actions or other proceedings which may be made or instituted by any third
party against any of them arising out of (i) a material breach of diaDexus'
representations, warranties or covenants under this Agreement, (ii) the
development, manufacture, possession, distribution, use, testing, sale or
other disposition of any Product by diaDexus or its sublicensees, (iii)
products liability arising from the use by any third party of Product(s)
sold by or on behalf of diaDexus or its sublicensees, or (iv) the gross
negligence, recklessness or intentional misconduct of diaDexus in
connection with activities to be performed under this Agreement, except to
the extent such losses, liabilities, damages and expenses (including
reasonable attorney's fees and costs) resulted from the gross negligence,
recklessness or intentional misconduct of Incyte and/or from the activities
covered under Section 9.2 (i) and/or (ii).
9.2 Indemnification by Incyte. Incyte shall indemnify, defend and hold
diaDexus, and sublicensees harmless from and against any and all losses,
liabilities, damages and expenses (including reasonable attorney's fees and
costs) as the result of claims, demands, actions or proceedings which may
be made or instituted by any third party against any of them arising out of
(i) a material breach of Incyte's representations, warranties or covenants
under this Agreement, (ii) the manufacture, possession, distribution, use,
testing, sale or other disposition of any product by Incyte, its affiliates
or licensees (other than diaDexus or sublicensees), or (iii) the gross
negligence, recklessness or intentional misconduct of Incyte or its
affiliates in connection with activities to be performed under this
Agreement.
9.3 Procedure. A party that intends to claim indemnification under this Article
9 (the "Indemnitee") shall promptly notify the indemnifying party (the
"Indemnitor") of any loss, liability, damage, expense, claim, demand,
action or other proceeding in respect of which the Indemnitee or any of its
affiliates intend to claim such indemnification, and the Indemnitor shall
have the right to participate in, and, to the extent the Indemnitor so
desires, jointly with any other
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Indemnitor similarly noticed, to assume the defense thereof with counsel
selected by the Indemnitor and reasonably satisfactory to the Indemnitee;
provided, however, that the Indemnitee shall have the right to retain its
own counsel, with the fees and expenses to be paid by the Indemnitee. The
indemnity provisions in this Article 9 shall not apply to amounts paid in
settlement of any loss, liability, damage, expense, claim, demand, action
or other proceeding if such settlement is effected without the consent of
the Indemnitor, which consent shall not be withheld unreasonably. The
failure to deliver notice to the Indemnitor within a reasonable time after
the commencement of any such action, if prejudicial to the Indemnitor's
ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Article 9, but the omission so to
deliver notice to the Indemnitor will not relieve it of any liability that
it may have to any Indemnitee otherwise than under this Article 9. The
Indemnitor may not settle the action or otherwise consent to an adverse
judgment in action or other proceeding that materially diminishes the
rights or interests of the Indemnitee without the express written consent
of the Indemnitee. The Indemnitee under this Article 9 and its employees
and agents, shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability
covered by this indemnification.
10.0 MISCELLANEOUS PROVISIONS
10.1 This Agreement shall not become effective until Amendment 4 of the
Collaboration and License Agreement among Incyte, diaDexus, and Xxxxx Xxxxx
Xxxxxxx, ("Amendment No. 4"), as appended hereto as Exhibit I has been
fully executed.
10.2 No Partnership. Nothing in this Agreement is intended or shall be deemed to
constitute a partnership, agency, distributorship, employer-employee or
joint venture relationship between the Parties. No party shall incur any
debts or make any commitments for the other, except to the extent, if at
all, specifically provided herein.
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10.3 Assignments. Neither party shall assign any of its rights or obligations
hereunder except: (i) as incident to the merger, consolidation,
reorganization or acquisition of stock or assets or similar transaction
affecting all or substantially all of the assets or voting control of the
assigning party; or, in the case of Incyte, to any of Incyte's directly
or indirectly wholly owned subsidiaries provided that the assigning party
remains liable and responsible for such diaDexus or Incyte subsidiary's
performance hereunder, as applicable; (ii) in the case of Incyte, as
incident to the acquisition or transfer of the assets affecting all or
substantially all of the assets of Incyte's business relating to a given
field of use, provided that the acquiring entity or transferee continues
to fulfill its obligations hereunder; (iii) with the consent of the other
party, which consent shall not be withheld unreasonably. This Agreement
shall be binding, upon the successors and permitted assigns of the
Parties. Any assignment not in accordance with the above shall be void.
To the extent that any assignment by diaDexus hereunder would directly
result in an increase in any withholding taxes for which Incyte is
responsible under this Agreement, diaDexus shall be responsible for such
additional taxes.
In the event of diaDexus' merger with or acquisition of or by a third
party who is not a LifeSeq Subscriber, if such third party's annual R&D
expenditures are equal to 50% of diaDexus' annual R&D expenditures, with
such R&D expenditures measured for the previous 4 fiscal quarters, annual
subscription fees consistent with that of Incyte's other commercial
LifeSeq subscriptions with similar access and license rights and similar
R&D expenditures shall automatically become applicable commencing on the
date of closing of the merger or acquisition and continuing through the
balance of the Access Term.
In no event will diaDexus' LifeSeq(R) Database Product(s) access rights
be assignable to a successor or permitted assignee if Incyte's
obligations thereunder would increase materially as a result of the
assignment (e.g. by having to service additional sites, or where Incyte
would incur a material increase in expenses and/or services over those
provided to diaDexus hereunder), unless such successor or permitted
assign provides appropriate pro-rated adjustment of the access fees,
service charges or Incyte costs incurred, and consistent with access
fees, service charges or Incyte costs incurred pertaining to comparable
database services customers.
10.4 No Trademark Rights. Except as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner the
names "Incyte" or "diaDexus", or any other trade name or trademark of
Incyte or diaDexus or their affiliates in connection with the performance
of this Agreement.
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10.5 Public Announcements. Incyte and diaDexus may announce the existence of
this Agreement, subject to mutual approval of any such announcement,
which approval will not be unreasonably withheld. Except as contemplated
by the last sentence or as may otherwise be required by law or
regulation, neither party shall make any public announcement concerning
this Agreement or the subject matter hereof without the prior consent of
the other party. If this Agreement is determined to be material to the
business of Incyte (or diaDexus) so that its disclosure is required by
law or regulation, diaDexus (or Incyte) shall have the right to review
and comment of the text of the disclosure prior to its release to the
public.
10.6 Entire Agreement of the Parties; Amendments. This Agreement constitutes
and contains the entire understanding and agreement of the Parties and
cancels and supersedes any and all prior negotiations, correspondence,
representations, understandings and agreements, whether verbal or
written, between the Parties respecting the subject matter hereof, except
that the June 30, 1995 Confidential Disclosure Agreement between the
parties shall govern disclosures prior to the execution of this
Agreement. No waiver, modification or amendment of any provision of this
Agreement shall be valid or effective unless made in writing and signed
by a duly authorized officer of each of the Parties.
10.7 Applicable Law. This Agreement shall be governed by and interpreted in
accordance with the laws of the State of Delaware, without reference to
the conflicts of law principles thereof. The parties expressly exclude
application of the United Nations Convention for the International Sale
of Goods. English shall be the governing language of this Agreement.
10.8 Notices and Deliveries. Any notice, requests, delivery, approval or
consent required or permitted to be given under this Agreement shall be
in writing and shall be deemed to have been sufficiently given if
delivered in person, transmitted by commercial overnight courier, or
transmitted by telex telegram or telecopy (facsimile, with confirmed
receipt) to the party to whom it is directed at its address shown below
or such other address as such party shall have last given by notice to
the other party (referred to herein as "notice"). All notices shall be
effective upon receipt.
If to Incyte, addressed to:
Incyte Pharmaceuticals, Inc.
0000 Xxxxxx Xxxxx
Xxxx Xxxx, XX 00000
Attn: General Counsel
If to diaDexus, addressed to:
diaDexus LLC.
0000 Xxxxxxxx Xxxxx
Xxxxx Xxxxx, XX 00000
Attn: President & Chief Operating Officer
10.9 Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
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constitute one and the same instrument.
10.10 Force Majeure. Force Majeure shall mean an Act of God, flood, fire,
explosion, earthquake, strike, lockout, casualty or accident, war, civil
commotion, act of public enemies, blockage or embargo, or any injunction,
law, order, proclamation, regulation, ordinance, demand or requirement of
any government or any subdivision, authority representative thereof, or
the inability to procure or use materials, labor, equipment,
transportation or energy sufficient to meet manufacturing needs without
the necessity of allocation, or any other cause whatsoever, whether
similar or dissimilar to those enumerated above, which are beyond the
reasonable control of such party, which the party affected has used its
reasonable best efforts to avoid, and which prevent, restrict or
interfere with the performance by a party of its obligations hereunder.
The party affected by Force Majeure shall give notice to the other party
promptly in writing and whereupon shall be excused from those obligations
hereunder, to the extent of such prevention, restriction or interference,
provided that the affected party shall use its commercially reasonable
efforts to overcome, avoid or remove such cause(s) of non-performance and
shall continue performance whenever such cause(s) is removed with all
possible speed. Nothing herein shall be deemed to require any party to
settle on terms unsatisfactory to such party with regard to any strike,
lock-out or other labor difficulty, any investigation or proceeding by
any public authority or any litigation by any third party.
10.11 Support. During the Access Term, Incyte shall provide to diaDexus such
support services for the LifeSeq(R) Database Products as Incyte provides
generally to its customers for the LifeSeq(R) Database Products,
including such new releases, enhancements and versions of such LifeSeq(R)
Database Products that are included in the definition of "LifeSeq(R)
Database Products" a designated contact for questions about the
LifeSeq(R) Database Products, and telephone and e-mail support.
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10.12 Software Escrow: During the Access Term and any extensions thereto,
Incyte shall maintain an escrow arrangement with a reputable escrow agent,
reasonably acceptable to diaDexus, to facilitate (a) diaDexus' deposit of
information concerning the identity of Gene Product(s) in Use or Used by
diaDexus as required under this Agreement and (b) Incyte's deposit of the
LifeSeq(R) Database Products, as further described in the Data and Software
Access Plan set forth in Exhibit E. Accordingly, Incyte represents that as
of the Effective Date, Incyte maintains an escrow with SourceFile, Inc.
(the "Escrow Agent") pursuant to the terms and conditions of the escrow
agreement set forth in Exhibit A, attached hereto and incorporated herein
by reference (the "Escrow Agreement"). Incyte shall add diaDexus as a
beneficiary under the Escrow Agreement within fourteen (14) days of the
execution of this Agreement by execution of the Form of Acknowledgement and
Amendment Number One thereto, comprising Exhibit B-1 of the Escrow
Agreement. For the avoidance of doubt, it is expressly understood that it
is the LifeSeq(R) Database Products as defined under this Agreement and
further described in the Data and Software Access Plan that Incyte shall
deposit into escrow, notwithstanding the use of the term "LIFESEQ(TM)" in
the Escrow Agreement or any other description contained in Exhibit A of the
Escrow Agreement. If for any reason the Escrow Agent does not agree to
execute the Form of Acknowledgement and Amendment Number One thereto,
comprising Exhibit B-1 to the Escrow Agreement, Incyte, diaDexus shall use
best efforts to agree upon a version of Exhibit B-1 to the Escrow Agreement
that he Escrow Agent will agree to sign.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized officers as of the Effective Date.
INCYTE PHARMACEUTICALS, INC.
By: [Signature Illegible]
---------------------------------
Name:
-------------------------------
Title:
------------------------------
Date:
-------------------------------
DIADEXUS, LLC
By: /s/ X. XXXXXXX
---------------------------------
Name: X. Xxxxxxx
-------------------------------
Title: President & COO
------------------------------
Date: 2/17/00
-------------------------------
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