EXHIBIT NO. 10.44
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
HAP-TM- FOCUS TRIAL LICENSE AGREEMENT
This AGREEMENT (the "Agreement") is made as of the 29th day of November 2001
(the "Effective Date"), by and between Genaissance Pharmaceuticals, Inc., a
Delaware Corporation with its principal place of business at Xxxx Xxxxxxx
Xxxx, Xxx Xxxxx, XX 00000 ("Genaissance"), and AstraZeneca UK Limited, a
United Kingdom company with its principal place of business at 00 Xxxxxxxx
Xxxx, Xxxxxx X0X 0XX, Xxxxxx Xxxxxxx ("AstraZeneca"). Genaissance and
AstraZeneca are sometimes referred to herein as a party and collectively as
the parties. Reference to a party herein includes a reference to its
Affiliates (as hereinafter defined) unless otherwise indicated.
RECITALS
WHEREAS, Genaissance has developed a fully integrated solution for
connecting genomic variation to drug response and disease susceptibility,
which is called HAP-TM- Technology, and which combines Genaissance's
proprietary haplotype markers, called HAP-TM- Markers (as hereinafter
defined) with the DECOGEN-TM- Informatics Platform (as hereinafter defined);
and
WHEREAS, AstraZeneca is interested in obtaining limited access to the
HAP-TM- Technology to investigate associations between HAP-TM- Markers and
disease susceptibility; and
WHEREAS, Genaissance is willing to grant AstraZeneca such limited
access, and to assist AstraZeneca in conducting this investigation, upon the
terms and conditions set forth below.
NOW THEREFORE, in consideration of the premises and of the covenants
herein contained, the parties hereto mutually agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "ACCESS PERIOD" shall mean the period between the Effective Date
and [**] after the Second Installation Date.
1.2 "AFFILIATE," shall mean any corporation, fern, partnership or
other legal entity which, directly or indirectly, controls, is controlled by,
or is under common control with a Party. For purposes of this definition,
control shall mean the direct or indirect ownership of more than fifty
percent (50%) of (i) the stock shares entitled to vote for the election of
directors or (ii) ownership interest of any such corporation, firm,
partnership or other legal entity.
1.3 "ASTRAZENECA DRUG" shall mean any therapeutic or prophylactic
compound, substance or agent including, without limitation, a small molecule,
protein, vaccine, antibody or nucleic acid that is covered by a Valid Claim
within AstraZeneca Patent Rights.
1.4 "ASTRAZENECA GENE ALLOCATION" shall mean the list of Genes to be
attached hereto as Exhibit B, PROVIDED THAT the list shall contain [**]
Genes. In the event that less than [**] genes are initially listed by
AstraZeneca in Exhibit B, AstraZeneca may add further genes up to a maximum
of [**] during the Access Period.
1.5 "ASTRAZENECA KNOW-HOW" shall mean any and all proprietary data,
information, know-how, inventions, trade secrets, copyrights, regulatory
submissions or other intellectual property of any kind, other than Patent
Rights, owned or controlled by AstraZeneca, as of the Effective Date or
during the Term.
1.6 "ASTRAZENECA PATENT RIGHTS" shall mean Patent Rights owned or
controlled by AstraZeneca, including the HAP-TM- Marker Patent Rights and
HAP-TM- Marker Association Patent Rights that are owned solely by AstraZeneca.
1.7 "ASTRAZENECA PROPRIETARY DATABASE" shall mean a database
installed on the Computer that contains, for the AstraZeneca disease cohort:
(a) Phenotypic Data, (b) HAP-TM- Markers, and (c) HAP-TM- Marker Associations.
1.8 "COMPUTER" shall mean a computer owned by Genaissance that is
installed by Genaissance at the AstraZeneca location identified in Exhibit C
pursuant to this Agreement.
1.9 "DATABASES" shall mean individually and collectively the HAP
FOCUS-TM- Database and the AstraZeneca Proprietary Database.
1.10 "DECOGEN-TM- INFORMATICS PLATFORM" shall mean software mid
components thereof and any associated documentation, whether existing on the
Effective Date or developed by Genaissance during the Access Period, which is
owned or controlled by, or licensed (with the right to sublicense) to
Genaissance, and which is designed to curate, collate and mine IN SILICO all
available gene variation data and to serve as a search engine to detect an
association between one or more HAP-TM- Markers or other polymorphic markers
(including SNPs, cSNPs and RFLPs) and a clinical endpoint and/or to
interpret, manipulate or analyze the data contained in the Databases, The
DECOGEN-TM- Informatics Platform shall not include any Third Party software
that AstraZeneca has independently of Genaissance licensed from a Third Party.
1.11 "DIAGNOSTIC PRODUCT" shall mean any product or service that (i)
is intended for use in diagnosing the presence of, or a susceptibility for,
any disease or condition in humans, and (ii) which directly or indirectly
measures a HAP-TM- Marker Combination corresponding to a HAP-TM- Marker
Association. FOR THE AVOIDANCE OF DOUBT, Diagnostic Products do not include
Prognostic Products.
1.12 "FIRST INSTALLATION DATE" shall have the meaning set forth in
Section 3.2 hereof.
1.13 "GENAISSANCE KNOW-HOW" shall mean any and all proprietary data,
information, know-how, inventions, trade secrets, copyrights, regulatory
submissions or other intellectual
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property of any kind, other than Patent Rights, owned solely by Genaissance,
as of the Effective Date or during the Term,
1.14 "GENAISSANCE PATENT RIGHTS" shall mean Patent Rights owned or
controlled by Genaissance, including the HAP-TM- Marker Association Patent
Rights that are owned solely by Genaissance.
1.15 "GENE" shall mean (a) a human nucleic acid sequence (including
allelic variations thereof) encoding a designated protein and (b) has known
genomic regions as set forth in Exhibit A hereto.
1.16 "HAP FOCUS-TM- DATABASE" shall mean a database installed on the
Computer that contains annotated data on the sequence, frequency and
distribution of HAP-TM- Markers for the AstraZeneca Gene Allocation, with
such HAP-TM- Markers generated by examining genomic DNA from the Index
Repository as more fully described in Exhibit A hereto.
1.17 "HAP-TM- MARKER" shall mean [**] a Gene [**] that (i) is
contained in the HAP FOCUS-TM- Database and (ii) was not known to AstraZeneca
prior to the First Installation Date and (iii) was known to AstraZeneca prior
to the First Installation Date if such knowledge was obtained after the
publication date of a, patent application owned by Genaissance and such HAP
Marker is covered by a Valid Claim.
1.18 "HAP-TM- MARKER ASSOCIATION" shall mean an association between a
specific HAP-TM- Marker or combination of HAP-TM- Markers and (a) the
presence of, or a susceptibility for, any disease or condition in humans,
where such association is discovered pursuant to this Agreement during the
Access Period.
1.19 "HAP-TM- MARKER ASSOCIATION PATENT RIGHTS" shall mean Patent
Rights claiming any HA PT" Marker Association or use thereof
1.20 "HAP-TM- MARKER COMBINATION" shall have the meaning set forth in
Section 2.1.4 hereof.
1.21 "HAP-TM- MARKER PATENT RIGHTS" shall mean Patent Rights claiming
a HAP-TM- Marker or use thereof.
1.22 "INDEX REPOSITORY" shall mean Genaissance's proprietary
collection of immortalized cell lines established from unrelated individuals
from various geographical origins and from members of extended families.
1.23 "NON-PROPRIETARY GENE" shall mean a Gene in the AstraZeneca Gene
Allocation that is not the subject of a patent or a patent application owned
by or exclusively licensed to AstraZeneca by a Third Party.
1.24 "PATENT RIGHTS" shall mean patents or patent applications as
described hereinafter which are owned or controlled (with the right to grant
licenses) by a party to this agreement. More particularly, Patent Rights
include (i) any United States or foreign patent application, (ii) any United
States patent or foreign patent issuing from such patent application and
(iii) any
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continuation, continuation-in-part (to the extent the claims in such
continuation-in-part application are directed to subject matter specifically
described in such prior patent application), divisional, reissue,
re-examination, renewal, substitution, addition, extension, supplementary
protection certificate or foreign counterpart thereof of any of the foregoing.
1.25 "PHARMACOGENETIC SERVICES" shall mean any and all services
relating to the use of genetic variation in the design and/or analysis of
human clinical trials of approved or new drugs, including but not limited to
discovery of genetic variants, detection of genetic variants in trial
subjects, and identification of associations between genetic variants and the
efficacy or safety of such drugs.
1.26 "PHENOTYPIC DATA" shall mean any and all phenotypic data
relating to a disease cohort that is possessed by AstraZeneca as of the
Second Installation Date, including without limitation the results of
physical measurements of individuals in the cohort, disease symptoms
exhibited by such individuals and any clinical diagnoses of such individuals.
1.27 "PROGNOSTIC PRODUCT" shall mean any product or service that (i)
is intended for use in connection with the sale or prescription of an
AstraZeneca Drug, and (ii) which directly or indirectly measures a HAP-TM-
Marker Combination corresponding to a HAP-TM- Marker Association.
1.28 "PROPRIETARY GENE" shall mean a Gene in the AstraZeneca Gene
Allocation that is the subject of a patent or patent application owned by or
exclusively licensed to AstraZeneca by a Third Party,
1.29 "SECOND INSTALLATION DATE" shall have the meaning set forth in
Section 3.4 hereof.
1.30 "SNP" shall mean a single nucleotide polymorphism.
1.31 "TERM" shall have the meaning set forth in Section 9.1 hereof.
1.32 "THIRD PARTY" shall mean any entity other than Genaissance or
AstraZeneca and their respective Affiliates.
1.33 "VALID CLAIM" shall mean either (i) a claim of a pending patent
application which claim was filed in good faith and has not been abandoned or
finally disallowed without the possibility of appeal or refiling of said
application or (ii) a claim of an issued and unexpired patent which has not
been held permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, Notwithstanding the foregoing,
if a claim of a pending patent application has not issued as a claim of an
issued patent within the Patent Rights within five (5) years after the filing
date from which such claim takes priority, such pending claim shall cease to
be a Valid Claim for purposes of this Agreement unless and until such claim
becomes an issued claim of an issued patent within the Patent Rights.
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ARTICLE 2
GRANTS OF RIGHTS
2.1 Rights granted to AstraZeneca by Genaissance.
2.1.1 NON-EXCLUSIVE R&D LICENSE TO THE DECOGEN-TM- INFORMATICS
PLATFORM AND HAP FOCUS-TM- DATABASE. Subject to the terms of this
Agreement and so long as AstraZeneca is not in breach of any of such
terms, Genaissance hereby grants to AstraZeneca during the Access
Period a [**]non-exclusive license, without the right to grant
sublicenses, under Genaissance Patent Rights and Genaissance Know-How
to access and use the DECOGEN-TM- Informatics Platform and HAP
FOCUS-TM- Database on the Computer solely for internal research and
development. AstraZeneca's use of the DECOGEN-TM- Informatics Platform
shall be limited to the purpose of obtaining access to, pursuing
searches in, and/or interpreting or analyzing the data contained in
the Databases as described under Article 3 below.
2.1.2 RESTRICTIONS ON USE OF THE DECOGEN-TM- INFORMATICS
PLATFORM AND DATABASES. AstraZeneca's use of the DECOGEN-TM-
Informatics Platform and Databases (except for HAP Markers for
Proprietary Genes and Phenotypic Data contained in the Databases)
shall be subject to the following conditions:
(a) The Computer may not be moved from the AstraZeneca
installation location specified in Exhibit C without the
prior written authorization of Genaissance.
(b) AstraZeneca is solely responsible for acquiring and
installing any hardware or software not specified in this
Agreement that is necessary for AstraZeneca to operate
the Computer and use the DECOGEN-TM- Informatics Platform.
(c) AstraZeneca shall not use the Computer, DECOGEN-TM-
Informatics Platform, or Databases to provide services
for, or to process information for, any Third Party.
(d) AstraZeneca agrees to make copies of the DECOGEN-TM-
Informatics Platform, HAP FOCUS-TM- Marker Database or
AstraZeneca Proprietary Database only to the extent
reasonably necessary to perform the Evaluation described
in Article 3 hereof, and further agrees that all such
copies will be treated as Confidential Information of
Genaissance.
(e) AstraZeneca shall not delete or permit to be deleted any
identifying marks, copyright or proprietary right,
notices of Genaissance from the DECOGEN-TM- Informatics,
Platform or Databases. AstraZeneca shall not translate,
decompile, nor create nor attempt to create, by reverse
engineering or otherwise, the source code from the object
code supplied hereunder, or adapt the DECOGEN-TM-
Informatics Platform or Databases in any way.
(f) Except as specifically authorized hereunder, AstraZeneca
shall not sell, transfer, publish, disclose, display or
otherwise make available any portion of the
DECOGEN-TM-Informatics Platform or Databases, specifically
5
including the data contained therein, to Third Parties or
permit Third Parties to access the Computer.
(g) AstraZeneca agrees to secure and protect the DECOGEN-TM-
Informatics Platform and Databases in a manner reasonably
consistent with the maintenance of rights therein, and in
accordance with the terms of this Agreement, and to take
appropriate action by instruction or agreement with its
employees who are permitted access to the Computer,
DECOGEN-TM- Informatics Platform or Databases to satisfy
its obligations hereunder. AstraZeneca shall cooperate
with and reasonably assist Genaissance in identifying and
preventing any unauthorized use, copying or disclosure of
the DECOGEN-TM- Informatics Platform or Databases.
AstraZeneca shall maintain records identifying the
specific individuals who have accessed the Computer,
DECOGEN-TM- Informatics Platform or Databases and shall
make copies of same available to Genaissance upon
Genaissance's reasonable request.
(h) Notwithstanding the foregoing, AstraZeneca shall, subject
to any pre-existing rights of Third Parties or
Genaissance, have an unlimited right to use data and
information generated from its use of and access to the
DECOGEN-TM- Informatics Platform and Databases solely for
internal research and development.
2.1.3 NON-EXCLUSIVE R&D LICENSE TO HAP-TM- MARKERS FOR
NON-PROPRIETARY GENES. Subject to the terms of this Agreement and so
long as AstraZeneca is not in breach of any of such terms, Genaissance
hereby grants to AstraZeneca a worldwide, [**] non-exclusive license,
without the right to grant sublicenses, under Genaissance Patent
Rights and Know-How to use the HAP-TM- Markers for Non-Proprietary
Genes solely for internal research and development during the Term.
2.1.4 EXCLUSIVE THERAPEUTIC LICENSE TO HAP-TM- MARKER
ASSOCIATIONS AND HAP-TM- MARKER COMBINATIONS. Subject to any
pre-existing rights of Genaissance or Third Parties, and in exchange
for the rights set forth in Section 2.2 hereof, Genaissance hereby
grants to AstraZeneca a [**], worldwide, [**] exclusive license, with
the right to grant sublicenses, under Genaissance Patent Rights and
Know-How to use HAP-TM- Marker Associations and their corresponding
HAP-TM- Marker Combinations from the Databases, to discover, develop,
make, have made, use, have used, market, have marketed, sell and have
sold any AstraZeneca Drug [**].
For purposes of this Agreement, HAP-TM- Marker Combination"
shall mean the specific HAP-TM- Marker or the specific group or
combination of HAP-TM- Markers (i) directly resulting from the
evaluation described in Article 3 that led to the discovery of the
HAP-TM- Marker Association, and (ii) any sub-combination thereof that
contains fewer HAP-TM- Markers than the combination described in the
foregoing subsection (i).
2.1.5 CO-EXCLUSIVE PROGNOSTIC LICENSE TO HAP-TM- MARKER
ASSOCIATIONS AND HAP-TM- MARKER COMBINATIONS. Subject to any
pre-existing rights of Genaissance or Third
6
Parties, and in exchange for the rights set forth in Section 2.2
hereof, Genaissance hereby grants to AstraZeneca a [**], worldwide,
[**], co-exclusive license (with Genaissance), with the right to grant
sublicenses, under Genaissance Patent Rights and Know-How to use
HAP-TM- Marker Associations and their corresponding HAP-TM- Marker
Combinations from the Databases, to make, have made, use, have used,
market, have marketed, sell and have sold Prognostic Products [**].
Any Prognostic Product that is sold by Genaissance or a
sublicensee shall be [**] that are [**].
2.2 Rights granted to Genaissance by AstraZeneca.
2.2.1 OPTION FOR CO-EXCLUSIVE PROGNOSTIC LICENSE TO HAP-TM-
MARKER ASSOCIATIONS AND HAP-TM- MARKER COMBINATIONS. Subject to the
terms of this Agreement and subject to any pre-existing rights of
AstraZeneca or Third Parties, AstraZeneca hereby grants to Genaissance
an exclusive option for a period of [**] from the Effective Date to
obtain a worldwide, co-exclusive license (with AstraZeneca), with the
right to grant sublicenses, under AstraZeneca Patent Rights and
Know-How to use HAP-TM- Marker Associations and their corresponding
HAP-TM- Marker Combinations, to make, have made, use, have used,
market, have marketed, sell and have sold Prognostic Products for all
disease indications. If Genaissance exercises its option, the license
terms shall be negotiated in good faith by the parties, with the
provisos (a) that the only payments owed by Genaissance to AstraZeneca
under such license will be [**] that is [**], and (b) that the royalty
rate shall not be greater than [**] percent net sales of such product.
Any Prognostic Product that is sold by Genaissance or a
sublicenses shall be [**] that are [**].
2.2.2 DEVELOPMENT OF PROGNOSTIC PRODUCTS. Subject to any
pre-existing rights of AstraZeneca or Third Parties, [**] to develop
any Prognostic Product to be marketed or sold by AstraZeneca or by a
sublicenses of AstraZeneca. If Genaissance exercises such right, the
parties shall negotiate in good faith to agree on a term sheet
therefore. In the event the parties are unable to agree on a term
sheet within [**]after Genaissance has exercised such right, [**] with
respect to such product,
2.2.3 OPTION FOR EXCLUSIVE DIAGNOSTIC LICENSE TO HAP-TM- MARKER
ASSOCIATIONS AND HAP-TM- MARKER COMBINATIONS. Subject to the terms of
this Agreement and subject to any pre-existing rights of AstraZeneca
or Third Parties, AstraZeneca hereby grants to Genaissance an
exclusive option for a period of [**] to obtain a worldwide, exclusive
license, with the right to grant sublicenses [**], under AstraZeneca
Patent Rights and Know-How to use HAP-TM- Marker Associations and
their corresponding HAP-TM- Marker Combinations, to make, have made,
use, have used, market, have marketed, sell and have sold any
Diagnostic Product. If Genaissance exercises its option, the license
terms shall be negotiated in good faith by the parties, with the
provisos (a) that the only payments owed by Genaissance to AstraZeneca
under the license will be [**] that is [**] and (b) that the royalty
rate shall not be greater than [**] percent.
7
2.2.4 FUTURE PHARMACOGENETIC SERVICES. Subject to any
pre-existing rights of AstraZeneca or Third Parties, [**] to provide
Pharmacogenetic Services for any future human clinical trial initiated
by AstraZeneca that is based on the results obtained by AstraZeneca
from the evaluation described in Article 3 hereof If Genaissance
exercises such right, the parties shall negotiate in good faith to
agree on a term sheet therefore. In the event the parties are unable
to agree on a term sheet within [**]after Genaissance has exercised
such right, [**] with respect to such product.
2.3 RESERVATION OF RIGHTS. Notwithstanding the rights granted to
AstraZeneca under this Article 2, Genaissance at all times reserves (i) its
rights to the HAP-TM- Markers for [**] contained in the HAP FOCUS-TM-
Database and (ii) its right to use such HAP-TM- Markers and the DECOGEN-TM-
Informatics Platform to research, develop, have developed, use, manufacture,
have manufactured, sell and have sold products, including the right to grant
licenses to Third Parties with respect to any Genaissance Know-How or Patent
Rights related to such purposes, PROVIDED THAT, no such license shall limit
the grants of right to AstraZeneca hereunder. AstraZeneca at all times
reserves its rights to HAP-TM- Markers for Proprietary Genes; Phenotypic
Data, AstraZeneca Know-How and AstraZeneca Patent Rights.
2.4 NO GRANT OF OTHER TECHNOLOGY OR PATENT RIGHTS. Except as
otherwise expressly provided in this Agreement, under no circumstances shall
a party hereto, as a result of this Agreement, obtain any ownership interest
in or other right to any technology, know-how, patents, patent applications,
data, products, or biological materials of the other party, including items
owned, controlled or developed by the other party, or transferred by the
other party to said party, at any time pursuant to this Agreement.. Any
compounds, technology or know-how derived, developed or acquired by either
party independent of use of or access to the Databases or the DECOGEN-TM-
Informatics Platform shall be the property of such party.
ARTICLE 3
EVALUATION: DELIVERY AND USE OF THE DATABASES AND
DECOGEN-TM- INFORMATICS PLATFORM
3.1 HAP-TM- MARKER DISCOVERY. AstraZeneca shall deliver to
Genaissance a description of the AstraZeneca Gene Allocation, which
description shall be attached hereto as Exhibit B. Genaissance shall promptly
initiate a program to discover HAP-TM- Markers for each of the Genes in the
AstraZeneca Gene Allocation using genomic DNA from the Index Repository as
described in Exhibit A and using its proprietary HAP-TM- Builder process.
This step will not be necessary for those Genes for which HAP-TM- Markers
have already been discovered as defined in Exhibit A.
To facilitate discovery of HAP-TM- Markers for Genes in the
AstraZeneca Gene Allocation, AstraZeneca shall provide at least one reference
genomic sequence for each Gene. If the sequence of the Gene is publicly
available, such reference sequence(s) need only be identified by an accession
number for a publicly available sequence database. For each Gene whose
sequence is not publicly available, AstraZeneca will provide an electronic
file containing at least one reference genomic sequence for such Gene in ASCI
II or FAST A format, as well as the genomic structure information known for
that Gene.
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3.2 INSTALLATION OF THE DECOGEN-TM- INFORMATICS PLATFORM AND HAP
FOCUS-TM- DATABASE. Upon completion of HAP-TM- Marker discovery, which is
expected to occur between about [**] weeks after receipt of Exhibit B,
Genaissance shall install at AstraZeneca a Computer containing the HAP
FOCUS-TM- Database and the DECOGEN-TM- Informatics Platform, with its
clinical features disabled (the "First Installation Date"). The First
Installation Date shall be no later than [**]from the Effective Date,
Genaissance shall provide [**] training at the location specified in Exhibit
C and shall also provide a DECOGEN-TM- user manual. Genaissance shall provide
any updates to the DECOGEN-TM- Informatics Platform that occur during the
Access Period.
3.3 GENOTYPING OF DISEASE COHORT. With the assistance and input of
Genaissance, AstraZeneca will use the DECOGEN-TM- Informatics Platform to
determine which SNPs should be genotyped to assign a pair of HAP-TM- Markers
to an individual (the "Minimal SNPs"). AstraZeneca will perform genotyping
for each of the Minimal SNPs on genomic DNA from a disease cohort designed by
AstraZeneca. It is expected that this genotyping will be complete within
about [**] from the First Installation Date.
3.4 DELIVERY OF ASTRAZENECA PROPRIETARY DATABASE. AstraZeneca will
promptly deliver to Genaissance the genotyping results for the Minimal SNPs
for each individual in the disease cohort, with the individuals identified
only by a code number known only to AstraZeneca. No Phenotypic Data will be
included with the genotype information. Genaissance shall promptly assign a
pair of HAP-TM- Markers to each individual using its proprietary HAP-TM-
Builder process. Within about [**] from receipt of the genotyping results,
Genaissance will send AstraZeneca the HAP-TM- Marker information obtained for
the disease cohort along with instructions for (i) installing this
information in the AstraZeneca Proprietary Database and (ii) enabling the
clinical features (the "Second Installation Date").
3.5 TESTING FOR HAP-TM- MARKER ASSOCIATIONS. AstraZeneca will use
the Databases to [**] to identify potential HAP-TM- Marker Associations.
3.6 TECHNICAL SUPPORT. Genaissance shall provide technical support
through a primary contact person who shall be accessible by telephone and
e-mail between the hours of 8.00 a.m. and 6:00 p.m. U. S. Eastern Time,
Monday through Friday or through additional on-site assistance. Genaissance's
actual and reasonable travel costs incurred in providing such additional
on-site assistance shall be reimbursed by AstraZeneca.
ARTICLE 4
PAYMENTS
4.1 LICENSE AND SERVICE FEES. In consideration of the rights granted
to AstraZeneca under Article 2 and the services performed by Genaissance
pursuant to Article 3, AstraZeneca agrees to pay Genaissance a fee of [**]
dollars ($[**]) [**], to be paid within [**] business days of receipt of an
invoice from Genaissance, such invoice to be issued upon delivery to
Genaissance of the description of the AstraZeneca Gene Allocation pursuant to
Section 3, 1.
4.2 MANNER OF PAYMENT. Payments to be made by AstraZeneca to
Genaissance under this Agreement shall be payable in United States dollars
and shall be paid by bank wire transfer
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in immediately available funds to such bank account in the State of
Connecticut as is designated in writing by Genaissance from time to time.
ARTICLE 5
INTELLECTUAL PROPERTY
5.1 OWNERSHIP OF INTELLECTUAL PROPERTY
5.1.1 OWNERSHIP OF THE DECOGEN-TM- INFORMATICS PLATFORM BY
GENAISSANCE. Subject to the rights and licenses granted under this
Agreement, and subject to any pre-existing rights of Third Parties,
Genaissance shall have sole ownership of (i) the HAP FOCUS-TM-
Database and (ii) the DECOGEN-TM- Informatics Platform.
5.1.2 OWNERSHIP OF HAP-TM- MARKERS FOR NON-PROPRIETARY GENES.
Subject to the rights and licenses granted under this Agreement, and
subject to any pre-existing rights of Third Parties, Genaissance shall
have sole ownership of all right, title and interest in all HAP-TM-
Markers for Non-Proprietary Genes, and all HAP-TM- Marker Patent
Rights for such Genes. In exchange for the rights granted under
Article 2, AstraZeneca shall execute and deliver, without charge to
Genaissance, assignment of all of its right, title and interest in and
to HAP-TM- Markers to Genaissance subject to AstraZeneca's right to
use the HAP-TM- Markers pursuant to the terms of this Agreement.
5.1.3 OWNERSHIP OF HAP-TM- MARKERS FOR PROPRIETARY GENES.
Subject to the rights and licenses granted under this Agreement, and
subject to any pre-existing rights of Third Parties, AstraZeneca shall
have sole ownership of all right, title and interest in all HAP-TM-
Markers for Proprietary Genes, and all HAP-TM- Marker Patent Rights
for such Genes.. In exchange for the rights granted under Article 2,
[**], assignment of all of its right, title and interest in and to
HAP-TM- Markers to AstraZeneca [**] pursuant to the terms of this
Agreement.
5.1.4 OWNERSHIP OF HAP-TM- MARKER ASSOCIATIONS. Unless modified
by a separate agreement entered into by the parties pursuant to
Section 5,1.5 hereof, [**] shall have [**] all right, title and
interest in all HAP-TM- Marker Associations and all HAP-TM- Marker
Association Patent Rights, In exchange for the rights granted under
Article 2, [**] right, title and interest in and to HAP-TM- Marker
Associations [**] HAP-TM- Marker Associations [**] and such HAP-TM-
Marker Associations shall be treated as the Confidential Information
of Genaissance and AstraZeneca.
5.1.5 MODIFICATION TO OWNERSHIP OF HAP-TM- MARKER ASSOCIATIONS.
Upon receipt of the AstraZeneca Gene Allocation, Genaissance shall
notify AstraZeneca of any Genes for which it has preexisting HAP-TM-
Marker Patent Rights. Before the Second Installation Date, the parties
will determine whether modification of ownership of any HAP-TM- Marker
Associations and HAP-TM- Marker Association Patent Rights would be
mutually beneficial in view of U.S. Patent Law, and any such
modification of ownership will be memorialized in an amendment to this
Agreement.
5.1.6 COOPERATION OF EMPLOYEES. Each party represents and agrees
that all employees or others acting on its behalf pursuant to this
Agreement shall be obligated
10
under a binding written agreement to assign to such party all
inventions made or conceived by such employee or other person.
5.2 FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
5.2.1 HAP-TM- MARKER PATENT RIGHTS FOR NON-PROPRIETARY GENES.
Genaissance shall have sole responsibility for and control over the
filing, prosecution and maintenance of the HAP-TM- Marker Patent
Rights for Non-Proprietary Genes, at Genaissance's expense.
Genaissance will seek method claims covering the detection of HAP-TM-
Markers for such genes and/or their component SNPs and composition of
matter claims covering genotyping oligonucleotides for use in the
detection methods. Genaissance will file, prosecute and maintain, to
the extent reasonable, such HAP-TM- Marker Patent Rights in the United
States, Europe, Japan and other countries.
In the event that (i) Genaissance determines that it will not seek
Patent Rights with respect to-any HAP-TM- Marker within a HAP-TM- Marker
Combination licensed to AstraZeneca pursuant to Article 2 hereof or (ii)
Genaissance files Patent Rights for such HAP-TM- Markers in one or more
countries but subsequently determines, on a country-by-country basis, that it
will not file, prosecute or maintain any HAP-TM- Marker Patent Right, or
(iii) elects not to file in countries which AstraZeneca elects to seek
protection, then Genaissance shall provide not less than [**] days notice of
its decision to AstraZeneca and any other licensee of such HAP-TM- Marker
Patent Rights. AstraZeneca and any other licensee of such HAP-TM- Marker
Patent Rights shall have the option to require Genaissance to prosecute such
HAP-TM- Marker Patent Rights, in Genaissance's name, at the expense of
AstraZeneca and any other licensees that agree to share the costs thereof pro
rata.
5.2.2 HAP-TM- MARKER PATENT RIGHTS FOR PROPRIETARY GENES.
AstraZeneca shall have sole responsibility for and control over the
filing, prosecution and maintenance of the HAP-TM- Marker Patent
Rights for Proprietary Genes, at AstraZeneca's expense. AstraZeneca
will seek method claims covering the detection of HAP-TM- Markers for
such genes and/or their component SNPs and composition of matter
claims covering genotyping oligonucleotides for use in the detection
methods. AstraZeneca will file, prosecute and maintain, to the extent
reasonable, such HAP-TM- Marker Patent Rights in [**] other countries.
In the event that (i) AstraZeneca determines that it will not seek
Patent Rights with respect to any HAP-TM- Markers within a HAP-TM- Marker
Combination for which Genaissance has an option to license, or has exercised
such option, pursuant to Article 2 hereof, or (ii) AstraZeneca files Patent
Rights for such HAP-TM- Markers in one or more countries but subsequently
determines, on a country-by-country basis, that it will not file, prosecute
or maintain any HAP-TM- Marker Patent Right, or (iii) elects not to file in
countries which AstraZeneca elects to seek protection, then AstraZeneca shall
provide not less than [**]days notice of its decision to Genaissance.
Genaissance shall have the option to require AstraZeneca to prosecute such
HAP-TM- Marker Patent Rights, in AstraZeneca's name, at the expense of
Genaissance.
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5.2.3 HAP-TM- MARKER ASSOCIATION PATENT RIGHTS. AstraZeneca
shall have sole responsibility for and control over the filing,
prosecution and maintenance of the HAP-TM- Marker Association Patent
Rights, at AstraZeneca's expense. AstraZeneca will seek method claims
covering the use of HAP-TM- Marker Combinations for all prognostic and
diagnostic purposes supported by the particular HAP-TM- Marker
Association. AstraZeneca will file, prosecute and maintain, to the
extent reasonable, such HAP-TM- Marker Association Patent Rights in
[**] other countries. Genaissance shall make its employees available
to AstraZeneca to assist in the preparation, filing, prosecution, and
maintenance of Patent Rights for those HAP-TM- Marker Associations
disclosed to Genaissance pursuant to Section 5.1.4.
In the event that (i) AstraZeneca determines that it will not seek
Patent Rights with respect to any HAP-TM- Marker Association for which
Genaissance has an option to license, or has exercised such option, pursuant
to Article 2 .hereof, or (ii.) AstraZeneca files Patent Rights for such
HAP-TM- Marker Association in one or more countries but subsequently
determines, on a country-by-country basis, that it will not file, prosecute
or maintain any HAP-TM- Marker Association Patent Right, or (iii) elects not
to file in countries which Genaissance elects to seek protection, then
AstraZeneca shall provide not less than [**] days notice of its decision to
Genaissance. Genaissance shall have the option to require AstraZeneca to
prosecute such HAP-TM- Marker Association Patent Right, in AstraZeneca's
name, at the expense of Genaissance.
5.2.4 PARTICIPATION IN PATENT PROSECUTION. The party responsible
for pursuing any Patent Rights pursuant to Article 5 hereof (the
"Responsible Party") shall keep the other party informed regarding the
status of such Patent Rights. If the other party is a licensee of the
Patent Right pursuant to Article 2 hereof, the licensee will be
provided in a timely manner with copies of all correspondence with the
applicable patent office(s) and will be provided with the opportunity
to review and comment upon any papers, responses or other filings
prepared by the Responsible Party for submission to the said offices
in advance of their ding and the Responsible Party shall use
reasonable efforts to incorporate any comments requested by the
licensee
ARTICLE 6
CONFIDENTIALITY
6.1 CONFIDENTIAL INFORMATION. Confidential Information shall mean,
subject to the limitations and exceptions described in Section 6.2.2, (i) any
information and data received by a party from the other party in connection
with the performance of this Agreement (and which, in the case of AstraZeneca
as recipient, shall include without limitation the HAP FOCUS-TM- Database and
all information contained therein related to HAP-TM- Markers for
Non-Proprietary Genes and the DECOGEN-TM- Informatics Platform, and which, in
the case of Genaissance as recipient, shall include without limitation
HAP-TM- Markers for Proprietary Genes, any information and data relating to
AstraZeneca's research and development efforts using the Databases and the
DECOGEN-TM- Informatics Platform, as well as any research, besting, clinical,
regulatory, marketing or other scientific or business information, plans or
data pertaining to .any product of AstraZeneca) and (ii) all information and
data not described in clause (i) but supplied by either party in connection
with this Agreement and marked "Confidential."
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6.2 NONDISCLOSURE OBLIGATIONS.
6.2.1 GENERAL. Except as otherwise provided in this Article 6,
during the term of this Agreement and for a period of ten (10) years
thereafter, the parties shall maintain the Confidential Information in
confidence and use it only for purposes specifically authorized under
this Agreement.
6.2.2 LIMITATIONS. The parties agree that the receiving party
shall not have any obligation of confidentiality with respect to such
Confidential Information that; (a) is or becomes part of the public
domain other than by unauthorized acts of the party obligated not to
disclose such Confidential Information; (b) can be shown by written
documents to have been disclosed to the receiving party by a Third
Party, provided such Confidential Information was not obtained by such
Third Party directly or indirectly from the other party to this
Agreement pursuant to a confidentiality agreement; (c) prior to
disclosure under this Agreement, was already in the possession of the
receiving party, provided such Confidential Information was not
obtained directly or indirectly from the other party to this Agreement
pursuant to a confidentiality agreement; (d) can be shown by written
documents to have been independently developed by the receiving party
without breach of any of the provisions of this Agreement; (e) is
disclosed by the receiving party pursuant to an order or demand issued
by a court or governmental agency or as otherwise required by law;
PROVIDED, HOWEVER, that the receiving party notifies the other party
prior to disclosure, giving such other party sufficient advance notice
to permit it to seek a protective order or other similar order with
respect to such Confidential Information AND PROVIDED, FURTHER, that
the receiving party furnishes only that portion of the Confidential
Information which it is advised by counsel is legally required whether
or not a protective order or other similar order is obtained by the
other party; or (f) where the receiving parry reasonably believes such
disclosure is reasonably necessary or appropriate to fulfill its
obligations or exercise its rights under this Agreement, with such
disclosure being limited to: (i), consultants, outside contractors and
clinical investigators, on a need-to-know basis and on condition that
such entities or persons agree to keep the Confidential Information
confidential for the same time periods and to the same extent as such
party is required to keep the Confidential Information confidential;
and (ii) government or other regulatory authorities to the extent that
such disclosure is reasonably necessary to obtain patents or
authorizations to conduct clinical trials of, and to commercially
market, products pursuant to this Agreement.
6.3 INJUNCTIVE RELIEF. The parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of any of the
provisions of this Article 6 by either party or their employees, agents,
officers or directors or any other person acting in concert with it or on its
behalf. Accordingly, each party may be entitled to the granting of injunctive
relief by a court of competent jurisdiction against any action that
constitutes any such breach of this Article 6.
6.4 PUBLICATION. Either party may publish or present data and/or
results generated utilizing the HAP-TM- Markers, provided, that in the event
that a party desires to publish or present any Confidential Information of
the other party, then the proposed disclosure shall be subject to the prior
review by the other party solely to determine (i) whether the proposed
disclosure
13
contains the Confidential Information of the other party or (ii) whether the
information contained in the proposed disclosure should be the subject of a
patent application- prior to such disclosure. Each party shall provide the
other party with the opportunity to review any proposed abstract, manuscript
or presentation which discloses Confidential Information of the other party
by delivering a copy thereof to the other party no less than [**] before its
intended submission for publication or presentation. The other party shall
have [**] from its receipt of any such abstract, manuscript or presentation
in which to notify the party in writing of any specific objections to the
disclosure, based on either the need to seek patent protection or concern
regarding the specific disclosure of the Confidential Information of such
party. In the event a party objects to the disclosure, the other party agrees
not to submit the publication or make the presentation containing the
objected-to information until the party is given a reasonable additional
period of time (not to exceed an additional [**]) to seek patent protection
for any material in the disclosure which it believes is patentable or, in the
case of Confidential Information, to allow the party to delete any
Confidential Information of the other party from the proposed disclosure.
Each party agrees to delete from the proposed disclosure any Confidential
Information of the other party upon request.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
7.1 REPRESENTATIONS, WARRANTIES AND COVENANTS OF GENAISSANCE.
Genaissance represents and warrants to and covenants with AstraZeneca that:
(a) Genaissance is a corporation duly organized, validly
existing and in corporate good standing under the laws of Delaware;
(b) Genaissance has the legal right, authority and power to
enter into this Agreement, and to extend the rights and licenses granted to
AstraZeneca in this Agreement;
(c) Genaissance has taken all necessary action to authorize the
execution, delivery and performance of this Agreement;
(d) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of Genaissance
enforceable in accordance with its terms, except as enforceability may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors' and contracting parties' rights generally
and except as enforceability may be subject to general principles of equity
(regardless of whether such enforceability is considered in a proceeding in
equity or at law);
(e) the performance of its obligations tinder this Agreement
will not conflict with its charter documents or result in a breach of any
agreements, contracts or other arrangements to which it is a party;
(f) to the best of Genaissance's knowledge but without
independent investigation, the performance of Genaissance's obligations under
this Agreement, including without limitation the delivery to AstraZeneca of
the Databases, the contents of the Databases and the DECOGEN-TM- Informatics
Platform, will not infringe, or shall be exempt from infringement of, any
issued patent or valid copyright of any Third Party;
14
(g) to the best of Genaissance's knowledge but without
independent investigation, the methods used by Genaissance for identifying
the HAP-TM- Markers, HAP-TM- Marker Combinations and HAP-TM- Marker
Associations do not infringe, or shall be exempt from infringement of, any
issued patent or valid copyright of any Third Party; and
(h) Genaissance will not during the term of this Agreement enter
into any agreements, contracts or other arrangements that would be
inconsistent with its obligations under this Agreement.
7.2 REPRESENTATIONS, WARRANTIES AND COVENANTS OF ASTRAZENECA.
AstraZeneca represents and warrants to and covenants with Genaissance that:
(a) AstraZeneca is a corporation duly organized, validly
existing and in corporate good standing under the laws of the United Kingdom;
(b) AstraZeneca has the legal right, authority and power to
enter into this Agreement, and to extend the rights and licenses granted to
Genaissance in this Agreement;
(c) AstraZeneca has taken all necessary action to authorize the
execution, delivery and performance of this Agreement;
(d) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of AstraZeneca
enforceable in accordance with its terms, except as enforceability may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting creditors' and contracting parties' rights generally
and except as enforceability may be subject to general principles of equity
(regardless of whether such enforceability is considered in a proceeding in
equity or at law);
(e) the performance of its obligations under this Agreement will
not conflict with AstraZeneca's charter documents or result in a breach of
any agreements, contracts or other arrangements to which it is a party;
(f) all products or services requested by AstraZeneca hereunder
are solely for uses reasonably related to the development and submission of
information to the FDA; and
(g) AstraZeneca will not after the Effective Date enter into any
agreements, contracts or other arrangements that would be inconsistent with
its obligations under this Agreement.
7.3 LIMITED WARRANTIES RELATING TO PERFORMANCE OF THE DECOGEN-TM-
INFORMATICS PLATFORM. Genaissance warrants that the DECOGEN-TM- Informatics
Platform delivered to AstraZeneca represents the latest version of the
DECOGEN-TM- Informatics Platform that is available to licensees. Genaissance
does not represent that the operations of the DECOGEN-TM- Informatics
Platform will be trouble-free or that the DECOGEN-TM- Informatics Platform
contains no errors. Genaissance's only obligation to AstraZeneca with respect
to the DECOGEN-TM- Informatics Platform will be to use reasonable efforts
consistent with its normal business practices to promptly correct any errors;
in no event more than [**] days after becoming aware of the errors, to notify
AstraZeneca immediately after becoming aware of the errors and to otherwise
support
15
AstraZeneca as provided in Article 3, provided that in the event of any
errors causing a delay in AstraZeneca being able to perform any of its
activities contemplated by this Agreement, such time periods shall be
extended for the period of the delay suffered.
7.4 WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN
THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO THE
DATABASES, DECOGEN-TM- INFORMATICS PLATFORM, PATENT RIGHTS, GOODS, SERVICES
OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH
RESPECT TO ANY AND' ALL OF THE FOREGOING. GENAISSANCE MAKES NO REPRESENTATION
OR WARRANTIES WITH RESPECT TO ASTRAZENECA'S USE OF THE INFORMATION TO BE
PROVIDED TO IT HEREUNDER GENAISSANCE MAKES NO WARRANTY THAT THE DATABASES DO
NOT CONTAIN ERRORS OR THAT THE DATABASES CONTAIN ALL HAP-TM- MARKERS THAT ARE
ACTUALLY PRESENT BUT NOT DETECTED 1N THE INDEX REPOSITORY.
7.5 LIMITED LIABILITY. NOTWITHSTANDING ANYTHING ELSE IN THIS
AGREEMENT OR OTHERWISE TO THE CONTRARY, NEITHER GENAISSANCE NOR ASTRAZENECA
WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY
CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR
(I) ANY PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST
PROFITS OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR
SERVICES.
ARTICLE 8
INDEMNITY
8.1 ASTRAZENECA INDEMNITY OBLIGATIONS. AstraZeneca will, at its own
expense, indemnify and promptly reimburse Genaissance for the defense of, and
hold harmless Genaissance and its officers and employees, from and against
any and all claims, actions, liabilities, losses, damages, judgments, grants,
costs and expenses (including attorneys' fees) resulting from or pertaining
to (a) AstraZeneca's use or operation of the HAP-TM- Markers, DECOGEN-TM-
Informatics Platform, Databases or Computer or (b) a breach of any of the
warranties made hereunder by AstraZeneca.
8.2 GENAISSANCE INDEMNITY OBLIGATIONS. Genaissance agrees to defend,
indemnify and hold AstraZeneca, its officers and its employees and agents
harmless from and against any and all claims, actions, losses, damages,
judgments, grants or expenses (including attorneys' fees) arising as a result
of (a) claims by employees or contractors of Genaissance for bodily injury,
death or property damage arising out of the performance by Genaissance of any
activities under this Agreement; (b) the negligence, recklessness or
intentional misconduct of Genaissance in connection with its activities under
this Agreement or (c) a breach of any of the warranties made hereunder by
Genaissance.
8.3 LIMITATION ON INDEMNITY OBLIGATIONS. Neither party and its
respective employees and agents shall be entitled to the indemnities set
forth in Section 8.1 where the claim, loss,
16
damage or expense for which indemnification is sought was caused by a grossly
negligent or intentional act or omission by the other party, its directors,
officers, employees or authorized agents.
8.4 PROCEDURE. If the party being indemnified hereunder or its
respective employees or agents (the "Indemnitee") intends to claim
indemnification under this Article 8, the Indemnitee shall promptly notify
the other party (the "Indemnitor") of any loss, claim, damage, liability or
action in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall assume the defense thereof with
counsel mutually satisfactory to the parties; provided, however, that an
Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor, if representation of such Indemnitee
by the counsel retained by the Indemnitor would be inappropriate due to
actual or potential differing interests between such Indemnitee and any other
party represented by such counsel in such proceedings. The indemnity
agreement in this Article 8 shall not apply to amounts paid in settlement of
any loss, claim, damage, liability or action 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
its ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Article 8, 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 8. The
Indemnitee under this Article 8, 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. The
Indemnitor shall additionally be liable to pay the reasonable legal costs and
attorneys' fees incurred by the Indemnitee in establishing its claim for
indemnity.
ARTICLE 9
EXPIRATION AND TERMINATION
9.1 TERM OF AGREEMENT. Unless this Agreement is sooner terminated in
accordance with the provisions of this Article 9, the "Term" of this
Agreement shall commence on the Effective Date and expire three (3) years
from the Effective Date.
9.2 EVENTS OF DEFAULT.
9.2.1 DEFAULT BY EITHER PARTY. An Event of Default shall have
occurred upon (i) the occurrence of a material breach of this
Agreement (other than an Event of Default described in Section 9.3.2)
if the breaching party fails to remedy such breach within thirty (30)
days after written notice thereof by the non-breaching party or (ii)
the bankruptcy, insolvency, dissolution or winding up of a parry.
9.2.2 DEFAULT BY ASTRAZENECA. An Event of Default shall have
occurred if AstraZeneca fails to make any payments due hereunder, [**]
business days after Genaissance delivers written notice thereof to
AstraZeneca specifying such failure and its claim of right to terminate,
unless AstraZeneca makes such payments plus interest within such [**]
day period.
17
9.3 EFFECT OF AN-EVENT OF DEFAULT.
9.3.1 REMEDIES AVAILABLE TO GENAISSANCE. In the event that an
Event of Default occurs relating to AstraZeneca and AstraZeneca fails
to cure such default during any applicable cure period, Genaissance
shall have the right, at its option exercisable in its sole
discretion, in addition to any other rights or remedies available to
it at law or in equity, to terminate this Agreement upon notice
thereof to AstraZeneca, in which case (i) the options and licenses
granted to AstraZeneca pursuant to Article 2 shall terminate and (ii)
any and all information and materials provided by Genaissance pursuant
to this Agreement (including, without limitation, all copies of the
Databases and DECOGEN-TM- Informatics Platform), and any copies
thereof (including electronic copies) shall be promptly returned by
AstraZeneca to Genaissance, and AstraZeneca shall delete all copies of
the Databases and DECOGEN-TM- Informatics Platform from all computers
at its site on which such information has been installed or
transmitted.
9.3.2 REMEDIES AVAILABLE TO ASTRAZENECA. In the event that an
Event of Default occurs relating to Genaissance and Genaissance fails
to cure such default within the applicable cure period, then
AstraZeneca shall have the right, at its option exercisable in its
sole discretion, (i) to terminate this Agreement upon notice thereof
to Genaissance in which case (ii) the options and licenses granted to
Genaissance pursuant to AstraZeneca shall terminate and (iii) any and
all information and materials provided by AstraZeneca shall be
promptly returned to AstraZeneca in addition to seeking any rights or
remedies available to it at law or in equity, subject to the
limitations set forth in Section 7.5 and Section 10.6 hereof.
9.4 EFFECT OF EXPIRATION OF THE ACCESS PERIOD. Upon the expiration of
the Access Period, AstraZeneca shall destroy all copies of the DECOGEN-TM-
Informatics Platform and Databases, return the Computer to Genaissance, and
certify the completion of such steps in writing to Genaissance, Prior to the
expiration of the Access Period, Genaissance shall deliver to AstraZeneca all
HAP-TM- Marker information in the Databases in a "flat file" format, which
information AstraZeneca shall be free to use without limitation, subject to
the terms of this Agreement. The termination of the Access Period shall
automatically, and without further action by Genaissance, terminate and
extinguish the license rights granted pursuant to Sections paragraphs 2.1 and
2.2.
9.5 EFFECT OF EXPIRATION OR TERMINATION OF AGREEMENT. The expiration
or termination of this Agreement shall not relieve the parties of any
obligation accruing prior to such expiration or termination. The provisions
of Articles 5, 6, 8, 9 and 10, Sections 7.4 and 7.5 hereof, and the options
and licenses granted to either party pursuant to Article 2 hereof shall
survive the expiration or termination of this Agreement.
ARTICLE 10
MYSCELLANEOUS
10.1 FORCE MAJEURE. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or
18
results from causes beyond the reasonable control of the affected party,
including but not limited to fire, floods, embargoes, war, acts of war
(whether war is declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, acts of God or acts, omissions
or delays in acting by any governmental authority or the other party;
PROVIDED, HOWEVER, that the party so affected shall use reasonable commercial
efforts to avoid or remove such causes of nonperformance, and shall continue
performance hereunder with reasonable dispatch whenever such causes are
removed. Either party shall provide the other party with prompt written
notice of any delay or failure to perform that occurs by reason of FORCE
MAJEURE. The parties shall mutually seek a resolution of the delay or the
failure to perform as noted above.
10.2 ASSIGNMENT. This Agreement may not be assigned or otherwise
transferred by either party without the consent of the other party, such
consent not to be unreasonably withheld or delayed; PROVIDED, HOWEVER, that
either Genaissance or AstraZeneca may, without such consent, assign its
rights and obligations under this Agreement (i) to any Affiliate, or (ii) in
connection with a merger, consolidation or sale of substantially all of such
party's assets to an unrelated Third Party; PROVIDED, HOWEVER, that such
party's rights and obligations under this Agreement shall be assumed by its
successor in interest in any such transaction and shall not be transferred
separate from all or substantially all of its other business assets,
including those business assets that are the subject of this Agreement. Any
purported assignment in violation of the preceding sentence shall be void.
Any permitted assignee shall assume all obligations of its assignor under
this Agreement.
10.3 SEVERABILITY. Each party hereby agrees that it does not intend
to violate any public policy, statutory or common laws, rules, regulations,
treaty or decision of any government agency or executive body thereof of any
country or community or association of countries. Should one or more
provisions of this Agreement be or become invalid, the parties hereto shall
substitute, by mutual consent, valid provisions for such invalid provisions
which valid provisions in their economic effect are sufficiently similar to
the invalid provisions that it can be reasonably assumed that the parties
would have entered into this Agreement with such valid provisions. In case
such valid provisions cannot be agreed upon, the invalidity of one or several
provisions of this Agreement shall not affect the validity of this Agreement
as a whole, unless the invalid provisions are of such essential importance to
this Agreement that it is to be reasonably assumed that the parties would not
have entered into this Agreement without the invalid provisions.
10.4 NOTICES. Any consent, notice or report required or permitted to
be given or made under this Agreement by one of the parties hereto to the
other shall be in writing, delivered personally or by facsimile (and promptly
confirmed by telephone, personal delivery or courier) or courier, postage
prepaid (where applicable), addressed to such other party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and shall be effective upon receipt by
the addressee.
If to Genaissance: Genaissance Pharmaceuticals, Inc.
Xxxx Xxxxxxx Xxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxxx Xxxxxxxxxx, Ph.D.
Telephone: (000) 000-0000
19
Facsimile: (000) 000-0000
With a copy to: Xxxxxxx Xxxxxxxxx
Xxxx Xxxxxxx Xxxx
Xxx Xxxxx, XX 00000
If to AstraZeneca: AstraZeneca UK Limited,
Enabling Sciences and Technology
Xxxxxxxx Xxxxxxxx Xxxx
Xxxxxxxxxxxx Xxxxxxxx XXX 0 0XX
Xxxxxx Xxxxxxx
Attention: Xx. Xxxx X. Xxxxxxxx
Tel: 00 0000 000 000
Fax: 00 0000 000 000
10.5 APPLICABLE LAW. This Agreement shall be governed by and
construed in accordance with the laws of the State of Connecticut, without
giving effect to the choice of laws provisions thereof.
10.6 DISPUTE RESOLUTION.
10.6.1 The parties hereby agree that they will attempt in good
faith to resolve any controversy or claim arising out of or relating
to this Agreement promptly by negotiations. If a controversy or claim
should arise hereunder, the matter shall be referred to an individual
designated by the Chief Executive Officer (or the equivalent position)
of Genaissance and an individual designated by the Head of Global
Discovery (or the equivalent position) of AstraZeneca (the
"Representatives"), If the matter has not been resolved within thirty
(30) days of the first meeting of the Representatives of the parties
(which period may be extended by mutual agreement) concerning such
matter, subject to rights to injunctive relief and specific
performance, and unless otherwise specifically provided for herein,
any controversy or claim arising out of or relating to this Agreement,
or the breach thereof, will be settled as set forth in Section 10.6.2.
10.6.2 All disputes arising in connection with this Agreement
shall be finally settled by binding arbitration conducted in New York,
New York under the Commercial Arbitration Rules of the American
Arbitration Association by a single arbitrator appointed in accordance
with said Rules. Notwithstanding the above either party has the right
to bring suit in a court of competent jurisdiction against the other
party for (i) any breach of such other party's duties of
confidentiality pursuant to Article 6 of this Agreement and (ii) any
infringement of its own proprietary rights by the other party.
Judgment upon the arbitrator's award may be entered in any court of
competent jurisdiction. The award of the arbitrator may include
compensatory damages against either party, but under no circumstances
will the arbitrator be authorized to, nor shall he, award punitive
damages or multiple damages against either party. The parties agree
not to institute any litigation or proceedings against each other in
connection with this Agreement except as provided in this Section 10.6.
20
10.7 ENTIRE AGREEMENT. This Agreement, together with the exhibits
hereto, contains the entire understanding of the parties with respect to the
subject matter hereof. All express or implied agreements and understandings,
either oral or written, heretofore made are expressly merged in and made a
part of this Agreement. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by both parties hereto.
10.8 PUBLICITY. Except as required by law, Genaissance and
AstraZeneca each agree not to disclose the existence or any terms or
conditions of this Agreement to any Third Party without consulting the other
party prior to such disclosure.
10.9 HEADINGS. The captions to the several Articles and Sections
hereof are not a part of this Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
10.10 NO PARTNERSHIP. It is expressly agreed that the relationship
between Genaissance and AstraZeneca shall not constitute a partnership, joint
venture or agency. Neither Genaissance nor AstraZeneca shall have the
authority to make any statements, representations or commitments of any kind,
or to take any action, which shall be binding on the other, without the prior
consent of the other party to do so.
10.11 EXPORTS. The parties acknowledge that the export of technical
data, materials or products is subject to the exporting party receiving any
necessary export licenses and that the parties cannot be responsible for any
delays attributable to export controls which are beyond the reasonable
control of either party. Genaissance and AstraZeneca agree not to export or
re-export, directly or indirectly, any information, technical data, the
direct product of such data, samples or equipment received or generated under
this Agreement in violation of any applicable export control laws or
governmental regulations. Genaissance and AstraZeneca agree to obtain similar
covenants from their licensees, sublicensees and contractors with respect to
the subject matter of this Section.
10.12 WAIVER. The waiver by either party hereto of any right hereunder
or the failure to perform or of a breach by the other parry shall not be
deemed a waiver of any other right hereunder or of any other breach or
failure by said other party whether of a similar nature or otherwise.
10.13 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 constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have caused their duly authorized
officer to execute and deliver this Agreement as of the date first set forth
above.
ASTRAZENECA UK LIMITED GENAISSANCE PHARMACEUTICALS, INC.
By: /S/ CRW XXXXX By: /S/ K. NANDABALAN
------------------------------ ------------------------------
Name: CRW XXXXX
------------------------------ Name: Xxxxxxxx Xxxxxxxxxx, Ph.D.
21
Title: AUTHORIZED SIGNATORY Title: Vice President, Product Development
----------------------------
Date: 29-11-01
------------------------------ Date: DECEMBER 6, 2001
22
EXHIBIT A
HAP-TM- MARKER DISCOVERY
The current procedure for discovering HAP-TM- Markers for a Gene is to
sequence, from the Index Repository, ninety-three (93) individual samples of
human genomic DNA and one sample of chimpanzee genomic DNA. The genomic
regions of each Gene, which are targeted for sequencing, are as follows.
(i) "Exons" shall mean the genomic DNA segments of a Gene whose
sequence information is translated into the protein product of that Gene. The
goal is to obtain sequence information for all Exons of a Gene.
(ii) "Exon/Intron Junction" shall mean the junctions between the Exons
and the Introns in genomic DNA. Beginning with the initiation codon at one
end of a Gene and ending with the termination codon at the other end of a
Gene, the goal is to obtain sequence information for each Exon/Intron
Junction within this genomic region.
(iii) "Introns" shall mean the genomic DNA segments of a Gene, which
are located between Exons. Beginning with the initiation codon at one end of
a Gene and ending with the termination codon at the other end of a Gene, the
goal is to obtain a minimum of ten (10) to twenty (20) bases and a maximum of
one hundred (100) bases of sequence information from the Exon/Intron Junction
into the Intron for every Intron within this genomic region.
(iv) "Promoter" shall mean the region that is immediately upstream of
the genomic segment that is found at the five-prime end of a Messenger RNA
molecule. ("Messenger RNA" shall mean a ribonucleic acid sequence from which
the protein product of a Gene is translated.) The goal is to obtain sequence
information for up to one thousand (1000) bases of the Promoter.
(v) "Three-Prime Untranslated Region" shall mean the genomic region
immediately downstream from the termination codon of a Gene. The goal is to
obtain sequence information for at least one hundred (100) bases of the
Three-Prime Untranslated Region downstream of the termination codon.
Specific genomic sequence information is required to meet the 'goals
outlined in (i) through (v) above. If genomic sequence information is
available for a majority of these regions, even if the available genomic
sequence information is not sufficient to meet all of the goals in (i)
through (v) above, a Gene will still be queued for HAP-TM- Marker discovery.
A Gene shall be considered completely sequenced if sequence
information is obtained for: (i) at least [**] of the [**]; (ii) the [**]
containing the [**]; and (iii) [**]. A specific region targeted for
sequencing within a Gene shall be considered completely sequenced if sequence
information is obtained [**]. However, the presence of runs of guanine and
cytosine, secondary structure or errors in publicly available sequence
information may prevent the generation of sufficient sequence information for
that Gene to be considered completely sequenced as defined above.
Genaissance shall use commercially reasonable efforts to incorporate
into the HAP FOCUS-TM- Database other information about Genes, including:
[**].
23
EXHIBIT B
AstraZeneca Gene Allocation
(To be Supplied by AstraZeneca)
24
EXHIBIT C
Computer Installation Location
(To be supplied by AstraZeneca)
25
