EXHIBIT NO. 10.54
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
AMENDMENT TO THE HAP2000(TM) AGREEMENT
This Amendment to the HAP2000(TM) Agreement (the "Amendment") dated
November 22, 2002 (the "Effective Date"), is made by and between Genaissance
Pharmaceuticals, Inc., a Delaware corporation having its principal place of
business at Xxxx Xxxxxxx Xxxx, Xxx Xxxxx, Xxxxxxxxxxx 00000 ("Genaissance"), and
Xxxxxxx & Xxxxxxx Pharmaceutical Research & Development, L.L.C., having its
principal place of business at 000 X.X. Xxxxx 000, Xxxxxxx, XX 00000 ("JJPRD").
JJPRD and Genaissance are sometimes referred to herein individually 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.
WITNESSETH:
WHEREAS, Genaissance and Xxxxxxx Research Foundation, a division of Xxxxxxx
Pharmaceutical, N.V., have previously entered into the HAP2000(TM) Agreement
dated November 22, 2000 (the "Agreement");
WHEREAS, Xxxxxxx Pharmaceutica, N.V. has assigned all of the rights and
obligations of its Xxxxxxx Research Foundation division to its Xxxxxxx & Xxxxxxx
Pharmaceutical Research & Development division ("Xxxxxxx") as of January 1,
2002;
WHEREAS, JJPRD is an Affiliate of Xxxxxxx Pharmaceutica, N.V. hereunder,
Genaissance and Xxxxxxx Pharmaceutica, N.V. wish to make JJPRD a party to this
Amendment, JJPRD wishes to be a party to this Amendment, and any reference to
Xxxxxxx hereunder shall be a reference to Xxxxxxx Pharmaceutica, N.V. and JJPRD;
and
WHEREAS, the parties desire to amend certain terms of the Agreement and
incorporate this Amendment therein.
NOW THEREFORE, in consideration of the premises and of the mutual covenants
and agreements contained herein and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties
intending to be legally bound agree as follows:
1. DEFINITIONS. All capitalized terms used herein and not otherwise defined
zherein shall have the respective meanings given to them in the Agreement.
2. AMENDMENTS TO AGREEMENT. The Agreement is, effective as of the Effective
Date hereof, hereby amended as follows:
A. Throughout the Agreement, "DECOGEN(TM)" is replaced with "DECOGEN(R)".
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B. Section 1.22 is hereby amended to read as follows:
1.22 "HAP(TM) MARKER ASSOCIATION" shall mean all associations
between HAP(TM) Markers or HAP(TM) Marker Combinations and (a) the
response to a Drug within a Drug Class or (b) the presence of, or a
susceptibility for, any disease or condition in humans, where such
association is discovered [**].
C. A new section 1.55 is hereby added, which reads as follows:
1.55 "[**] RESEARCH PROJECT" shall mean the Research Project
performed jointly by Xxxxxxx and Genaissance to look for HAP Marker
Associations relating to response to [**] to be more fully described
in EXHIBIT H3 to be appended hereto within [**] days of the Effective
Date of this Amendment and any updates thereto which are added prior
to the end of the Access Period.
D. A new section 1.56 is hereby added, which reads as follows:
1.56 "[**] RESEARCH PROJECT" shall mean the Research Project
performed jointly by Xxxxxxx and Genaissance to look for HAP Marker
Associations relating to response to [**], to be more fully described
in an EXHIBIT H4 to be appended hereto prior to [**].
E. A new section 1.57 is hereby added, which reads as follows:
1.57 "[**] RESEARCH PROJECT" shall mean the Research Project
performed jointly by Xxxxxxx and Genaissance to look for HAP Marker
Associations relating to [**] genes, to be more fully described in an
EXHIBIT H2 appended hereto, and any updates thereto which are added
within [**] days of the Effective Date of this Amendment.
F. A new section 1.58 is hereby added, which reads as follows:
1.58 "[**] RESEARCH PROJECT" shall mean the Research Project
performed jointly by Xxxxxxx and Genaissance to look for HAP Marker
Associations relating to [**], to be more fully described in an
EXHIBIT H5 to be appended hereto within [**] days of the Effective
Date of this Amendment and any updates thereto which are added prior
to [**].
G. A new section 1.59 is hereby added, which reads as follows:
1.59 "GENOTYPING PROJECT" shall have the meaning set forth in
Section 3.1(c).
H. A new section 1.60 is hereby added, which reads as follows:
1.60 "[**] GENOTYPING PROJECT" shall mean the Genotyping
Project in which Genaissance will genotype Xxxxxxx Patient Samples on
[**] genes as more fully described in EXHIBIT J1 to be appended hereto
within [**] days of the
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Effective Date of this Amendment and any updates thereto which are
added prior to the end of the Access Period.
I. A new section 1.61 is hereby added, which reads as follows:
1.61 "GENOTYPING SERVICES" shall have the meaning set forth
in Section 3.1(c).
J. A new section 1.62 is hereby added, which reads as follows:
1.62 "XXXXXXX PATIENT SAMPLE" shall mean any blood or DNA
sample that is (a) utilized by Xxxxxxx in a Research Project or (b)
supplied by Xxxxxxx to Genaissance for performing a Research Project
or a Genotyping Project.
K. Section 2.1.2 is hereby amended to read as follows:
2.1.2 RESEARCH LICENSES. Subject to the terms of this
Agreement, Genaissance hereby grants to Xxxxxxx the following
worldwide licenses under the Genaissance Know-How and Genaissance
Patent Rights:
(a) upon payment of the Product License Fee A set
forth in Section 4.5, an [**] license, with the right to grant
sublicenses in accordance with Section 2.1.8, to use (i) all genotype
and HAP Marker data generated by Xxxxxxx or Genaissance on Xxxxxxx
Patient Samples in the [**] Research Project and (ii) all HAP Marker
Associations and all HAP Marker Combinations discovered in the [**]
Research[**]Project solely for internal research to discover and
develop Drugs within a Drug Class; and
(b) upon payment of the Product License Fee B set
forth in Section 4.5, an [**] license, with the right to grant
sublicenses in accordance with Section 2.1.8, to use (i) all genotype
and HAP Marker data generated by Xxxxxxx or Genaissance on Xxxxxxx
Patient Samples in the [**] Research Project and (ii) all HAP Marker
Associations and all HAP Marker Combinations discovered in the [**]
Research Project solely for internal research to discover and develop
Drugs within a Drug Class; and
(c) an [**] license, with the right to grant
sublicenses in accordance with Section 2.1.8, to use (i) all genotype
and HAP Marker data generated by Xxxxxxx or Genaissance on Xxxxxxx
Patient Samples in any Research Project other than the [**] Research
Project or the [**] Research Project and (ii) all HAP Marker
Associations and all HAP Marker Combinations discovered in a Research
Project , other than the [**] Research Project or the [**] Research
Project, solely for internal research to discover and develop Drugs
within a Drug Class; and
(d) a [**] license, with the right to grant
sublicenses in accordance with Section 2.1.8, to use all HAP Marker
Associations and HAP
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Marker Combinations not included in subsection (a), (b) or (c) of this
Section 2.1.2 solely for internal research and development purposes;
and
(e) a [**] license, without the right to grant
sublicenses, to use the HAP(TM) Markers from the ISOGENOMICS(TM)
Database (and any corresponding Isogene Clones ordered by Xxxxxxx
pursuant to Section 3.7 hereof) solely for internal research and
development purposes during the Access Period and the Additional Use
Period, if applicable.
The [**] research and development licenses granted pursuant to
this section 2.1.2 will be subject to: (i) Genaissance's retention of
a [**] license [**] to use such HAP Marker Associations and HAP Marker
Combinations to develop and commercialize Diagnostic Products,
PROVIDED THAT Genaissance's [**] license under this Section 2.1.2
shall not include the right to make, have made, use, have used,
market, have marketed, sell and have sold any [**]; and (ii) any
rights granted by Genaissance to Third Parties before the discovery of
the licensed HAP Marker Associations and HAP Marker Combinations
referenced in subsection (a), (b) or (c) of this section 2.1.2,
pursuant to Section 5.1.3.
L. Section 2.1.3 is hereby amended to read as follows:
2.1.3 COMMERCIAL LICENSE(S) TO HAP(TM) MARKER COMBINATIONS AND
HAP(TM) MARKER ASSOCIATIONS. Subject to the terms of this Agreement,
Genaissance hereby grants to Xxxxxxx the following licenses:
(a) an exclusive, perpetual worldwide commercial
license (even as to Genaissance), with the right to grant sublicenses
in accordance with Section 2.1.8, under the Genaissance Patent Rights
and Genaissance Know-How to use all HAP(TM) Marker Associations
discovered in the [**]Research Project and all HAP(TM) Marker
Combinations relating to such Associations, to perform prospective
clinical trials, to make, have made, use, have used, market, have
marketed, sell and have sold (i) any Drug within a Drug Class for [**]
and (ii) any Diagnostic Product for [**];
(b) notwithstanding the exclusive license granted to
Xxxxxxx in Section 2.1.3(a), Genaissance shall have a co-exclusive,
perpetual worldwide commercial license (with only Genaissance and
Xxxxxxx retaining rights), with the right to grant sublicenses in
accordance with Section 2.1.8, under the Genaissance Patent Rights and
Genaissance Know-How to use all of the HAP(TM) Marker Associations and
HAP(TM) Marker Combinations referred to in the foregoing subsection
(a) to make, have made, use, have used, market, have marketed, sell
and have sold any Diagnostic Product PROVIDED THAT Genaissance's
co-exclusive license under this Section 2.1.3(b) shall not include the
right to make, have made, use, have used, market, have marketed, sell
and have sold any [**];
(c) an exclusive, perpetual worldwide commercial
license (even as to Genaissance), with the right to grant sublicenses
in accordance with
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Section 2.1.8, under the Genaissance Patent Rights and Genaissance
Know-How to use all HAP(TM) Marker Associations discovered in the
[**]Research Project or any other specific Research Project other than
the [**]Research Project and all HAP(TM) Marker Combinations relating
to such Associations, to perform prospective clinical trials, to make,
have made, use, have used, market, have marketed, sell and have sold
(i) any Drug within the Drug Class for [**] and (ii) any Diagnostic
Product for [**];
(d) notwithstanding the exclusive license granted to
Xxxxxxx in Section 2.1.3(c), Genaissance shall have a co-exclusive,
perpetual, worldwide commercial license (with only Genaissance and
Xxxxxxx retaining rights), with the right to grant sublicenses in
accordance with Section 2.1.8, under the Genaissance Patent Rights and
Genaissance Know-How to use all of the HAP(TM) Marker Associations and
HAP(TM) Marker Combinations referred to in the foregoing subsection
(c) to make, have made, use, have used, market, have marketed, sell
and have sold any Diagnostic Product, PROVIDED THAT Genaissance's
co-exclusive license under this Section 2.1.3(d) shall not include the
right to make, have made, use, have used, market, have marketed, sell
and have sold any [**];
PROVIDED THAT:
(i) the licenses in the foregoing subsections (a),
(b), (c) and (d) with respect to the [**] Research Project and
the [**]Research Project will be subject to any rights reserved
by Genaissance before the discovery of the HAP Marker
Associations and HAP Marker Combinations, where such
reservation by Genaissance of pre-existing rights is evidenced
by contemporary written documentation, and
(ii) the licenses in the foregoing subsections (a),
(b), (c) and (d) will be subject to any rights granted by
Genaissance to Third Parties before the discovery of the HAP
Marker Associations and HAP Marker Combinations, where such
grant of pre-existing rights by Genaissance is evidenced by
contemporary written documentation.
Genaissance shall [**] grant to Xxxxxxx a [**]commercial
license, with the right to grant sublicenses in accordance with
Section 2.1.8, under any other Patent Rights of Genaissance necessary
for Xxxxxxx to exercise its rights under the commercial licenses
obtained to HAP(TM) Marker Combinations and HAP(TM) Marker
Associations, except that such license shall not include any HAP(TM)
Marker Association Patent Rights not otherwise licensed to Xxxxxxx.
Notwithstanding the rights granted to Xxxxxxx in subsections
(a), (b), (c) and (d) above, Genaissance reserves the right to grant
to other HAP2000(TM) Members research and development licenses under
similar terms and conditions as those granted to Xxxxxxx under Section
2.1.1 and subsections (d) and (e) of section 2.1.2.
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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 [**] HAP(TM) Marker[**] HAP(TM) Markers
[**] HAP(TM) Marker [**] HAP(TM) Markers [**] HAP(TM) Marker
[**]HAP(TM) Marker [**] HAP(TM) Marker(s) [**] HAP(TM) Marker[**]
HAP(TM) Marker [**] HAP(TM) Markers [**] HAP(TM) Marker [**].
For purposes of this Agreement, "Disease Fields" shall mean (i)
with respect to a Drug for which a license is granted to Xxxxxxx under
Section 2.1.3(a) or 2.1.3(c) and which is covered by a Valid Claim of
Xxxxxxx Patent Rights owned by Xxxxxxx, any and all disease
indications (unless such Xxxxxxx Patent Rights are limited to the use
of the Drug for specific disease indications, in which case the
Disease Fields shall be limited to the disease indications included
within the scope of such Xxxxxxx Patent Rights) or (ii) with respect
to a Drug for which a license is granted to Xxxxxxx under Section
2.1.3(a) and which is covered by a Valid Claim of Xxxxxxx Patent
Rights licensed to Xxxxxxx, any and all disease indications included
in the field of the license to Xxxxxxx.
The existence of the license granted to Xxxxxxx under this
Section 2.1.3 will be noted in the ISOGENOMICS(TM) Database without
revealing the identity of Xxxxxxx, unless authorized by Xxxxxxx. In
the event similar license(s) are granted by Genaissance to another
HAP2000(TM) Member, the existence of such licenses will be noted in
the Isogenomics(TM) Database without revealing the identity of such
other HAP2000(TM) Member, unless authorized by such HAP2000(TM)
Member.
M. Section 2.1.4 is hereby amended to read as follows:
2.1.4 R&D LICENSE TO HAP MARKERS FOR XXXXXXX PROPRIETARY
DATABASE. Subject to the terms of this Agreement, Genaissance hereby
grants to Xxxxxxx a worldwide [**] license, [**], under the
Genaissance Patent Rights and Genaissance Know-How to use one or more
HAP Markers derived from the Xxxxxxx Proprietary Database (and any
corresponding Isogene Clones ordered by Xxxxxxx pursuant to section
3.7 hereof) solely for internal research and development purposes.
N. Section 2.1.8 is hereby amended to read as follows:
2.1.8 SUBLICENSING BY XXXXXXX. Xxxxxxx shall have the right to
grant sublicenses of the rights granted to Xxxxxxx pursuant to
Sections 2.1.2, 2.1.3, 2.1.4, and 2.1.5 to Third Parties for the
development and marketing of Products; PROVIDED that each Third Party
sublicensee shall execute a written agreement pursuant to which it
assumes the applicable obligations of Xxxxxxx hereunder.
O. A new sentence is added to the end of Section 2.4, NO GRANT OF OTHER
TECHNOLOGY OR PATENT RIGHTS, which reads as follows:
For purposes of clarity, Genaissance shall not obtain any ownership of
or license rights to discoveries, other than HAP Markers, HAP Marker
Associations and
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HAP Marker Combinations, that are made solely by Xxxxxxx using the
ISOGENOMICS Database, the DECOGEN(R) Informatics Platform or other
Genaissance Know-How and Genaissance Patent Rights licensed hereunder.
P. A new Section 2.5 is hereby added, which reads as follows:
2.5 LIMITATION ON GENAISSANCE'S [**] LICENSES. During the
Access Period, Genaissance will not use the ISOGENOMICS Database or
the HAP Markers in the ISOGENOMICS Database to research, develop or
commercialize Diagnostic Products for use in connection with any Drug
that (a) is within Xxxxxxx Patent Rights or (b) [**].
Q. A new section 3.1(c) is hereby added, which reads as follows:
3.1(c) GENOTYPING SERVICES. During the Access Period and the
Additional Use Period, if applicable, Xxxxxxx may request that
Genaissance determine for Xxxxxxx the genotypes for a set of one or
more Polymorphisms in a set of Xxxxxxx Patient Samples. Such
Genotyping Services shall not include Genaissance deriving HAP Markers
from such genotypes or performing any statistical analyses to
correlate genotypes with a phenotype. Furthermore, such Genotyping
Services shall not be considered to be part of any Research Project
hereunder except at the sole discretion of Xxxxxxx. Prior to
commencing Genotyping Services for a particular project, the parties
shall agree in writing on the scope of the services to be provided,
including, without limitation, whether the project will be considered
to be a Research Project hereunder, the Polymorphisms and the time
frame for completing the services, and the written description of this
project ("Genotyping Project") shall be appended to EXHIBIT J of this
Agreement. Xxxxxxx, at its option, may pay Genaissance for such
Genotyping Services from the minimum HAP Typing Services
payment owed by Xxxxxxx pursuant to Section 4.4 at the same rate of
$[**]. Upon full utilization by Xxxxxxx of such minimum HAP Typing
Services payment for HAP Typing Services or Genotyping Services,
Xxxxxxx shall pay Genaissance a fee of $[**].[**]
R. Section 4.1 is hereby amended to read as follows:
4.1 SUBSCRIPTION FEES. In consideration of the rights
granted to Xxxxxxx under Section 2.1, Xxxxxxx agrees to pay
Genaissance a subscription fee ("Subscription Fee") as follows:
For the first Agreement Year, [**] Dollars ($[**]);
For the second Agreement Year, [**] Dollars ($[**]); and
For the third Agreement Year, [**] Dollars ($[**])
which payments for each year shall be made either: (i) in equal
calendar quarterly payments in advance beginning within [**] days
after the Effective Date, except that the amounts of the first and
last payments for each Agreement year shall be prorated based on the
number of days in the applicable partial calendar quarter or
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(ii) with respect to the third Agreement Year, in full within [**]
after the second anniversary of the Effective Date. [**] Xxxxxxx [**]
Genaissance [**] Genaissance [**] Xxxxxxx [**] Genaissance [**]
Genaissance [**].
The Subscription Fee covers: (i) access to the ISOGENOMICS
Database in accordance with this Agreement; (ii) the installation,
technology transfer, training and support as provided in EXHIBIT C and
EXHIBIT D; (iii) the site license for the DECOGEN(R) Informatics
Platform; (iv) reserved capacity for HAP Typing Services; (v)
performance by Genaissance of Research Projects pursuant to Section
3.1(a), subject to payment of any applicable Set-up Fee set forth in
Section 4.2; and (vi) the Xxxxxxx Xxxx Allocation.
S. Section 4.2 is hereby amended to read as follows:
4.2. SET-UP FEE. For each Research Project mutually agreed to
be performed by Genaissance pursuant to Section 3.1(a) involving a
Drug or Diagnostic Product for which more than [**] of Genaissance's
services, excluding the time of the Genaissance project manager
described in EXHIBIT F, will be required to assist in preparation of
the plan for the Research Project, Xxxxxxx shall pay to Genaissance a
nonrefundable set-up fee (the "Set-Up Fee") in an amount to be
determined by the Steering Committee, based on payment to Genaissance
at the rate of $[**]. No set-up fee shall be due for the first [**]
such Research Projects initiated during the Access Period. For
purposes of clarity, the first [**] such Research Projects for which
no set-up [**] is due are the [**] Research Project described in
EXHIBIT H2, the [**] Research Project described in EXHIBIT H3, and the
[**] Research Project described in EXHIBIT H4. The Set-Up Fee shall be
provided to Genaissance within [**] days after the date the written
description for the Research Project is appended to this Agreement.
T. Section 4.4 is hereby amended to read as follows:
4.4 HAP TYPING SERVICE FEE. In the event Xxxxxxx requests
HAP Typing Services pursuant to Section 3.1(b), Xxxxxxx shall pay to
Genaissance a nonrefundable fee (the "HAP Typing Service Fee") of
$[**] delivered. The HAP Typing Service Fee includes (i) Genaissance
determining the genotypes for Polymorphisms and (ii) Genaissance
building the HAP Markers from such genotypes using its proprietary HAP
Builder program. The HAP Typing Service Fee shall be provided to
Genaissance quarterly for only those Polymorphisms genotyped during
the past quarter, upon receipt of an invoice from Genaissance. Xxxxxxx
agrees to pay Genaissance a minimum of $[**] for HAP Typing Services
during the first two (2) years of the Access Period. If, by the end of
the second year of the Access Period, Xxxxxxx has not paid Genaissance
at least $[**] for HAP Typing Services (including any additional
amounts paid at the end of the first year under the previous
sentence), Xxxxxxx agrees to pay Genaissance the difference between
$[**] and the sum actually paid, which amount may be applied by
Xxxxxxx as a credit towards any fees for HAP Typing Services or
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Genotyping Services performed by Genaissance during the balance of the
Access Period or Additional Use Period, if applicable.
U. Section 4.5 is hereby amended to read as follows:
4.5 PRODUCT LICENSE FEES. Xxxxxxx shall pay to Genaissance
within [**] days after the Effective Date of this Amendment (a) a
nonrefundable license fee of [**] Dollars ($[**]) in recognition of
all the licenses conferred to Xxxxxxx in Section 2.1.2(a), 2.1.3(a)
and 2.1.3(b) ("Product License Fee A") and (b) a nonrefundable license
fee of [**] Dollars ($[**]) in recognition of all other licenses
conferred to Xxxxxxx in Section 2.1.2(b), 2.1.2(c), 2.1.2(d),
2.1.3(c), 2.1.3(d) and 2.1.4 ("Product License Fee B").
V. Section 4.6 is hereby amended to read as follows:
4.6 MILESTONE PAYMENTS FOR INITIAL DRUG PRODUCTS AND INITIAL
DIAGNOSTIC PRODUCTS. Xxxxxxx shall pay to Genaissance a [**] payment
as set forth below upon the achievement of each of the applicable
milestones for the [**] for an Initial Drug Product and for Initial
Diagnostic Products. For the avoidance of doubt, it is understood and
agreed that [**] payment(s) under Sections 4.6.2(a) and 4.6.2(b) shall
be due and payable to Genaissance by Xxxxxxx [**] for all HAP(TM)
Marker Combinations and HAP(TM) Marker Associations licensed under
Section 2.1.3 or 2.1.5 hereof for any Initial Drug Product or Initial
Diagnostic Product. Fees for other Products are set forth in Section
4.8.
4.6.1 INITIAL DRUG PRODUCTS. Xxxxxxx shall pay to
Genaissance a [**] payment in the amount of [**] Dollars ($[**]) upon
[**]for an Initial Drug Product for which a license is granted to
Xxxxxxx pursuant to Section 2.1.3 or 2.1.5 hereof in any of the United
States, any Major European Country or Japan (e.g., when a milestone is
reached first, for example, in the United States, no payment is due
upon reaching the same milestone in another country for [**] for such
Initial Drug Product). It is agreed that Initial Drug Products that
arise from or relate to HAP Marker Combinations or HAP Marker
Associations discovered in the [**] Research Project or the [**]
Research Project will be excluded from payment of the lump sum royalty
for Initial Drug Products.
4.6.2 INITIAL DIAGNOSTIC PRODUCTS. Xxxxxxx shall pay to
Genaissance a [**] payment in the amount of [**] Dollars ($[**]) for
(a) the first Initial Diagnostic Product for which a license is
granted to Xxxxxxx pursuant to Section 2.1.3 or 2.1.5 hereof and which
is used in the prognosis of the response to an Initial Drug Product
and (b) each Initial Diagnostic Produc[**] for which a license is
granted to Xxxxxxx pursuant to Section 2.1.3 or 2.1.5 hereof and which
is not used in the prognosis of the response to an Initial Drug
Product, upon the receipt of the first regulatory approval in any of
the United States, any Major European Country or Japan (e.g., when a
milestone is reached first, for example, in the United States, no
payment is due upon reaching the same milestone in another country for
the same Initial Diagnostic Product).
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Xxxxxxx will immediately notify Genaissance upon the
accomplishment of the commercial use milestone for each Research
Project and the accomplishment of the milestone for each Product and,
within [**] days thereof, Xxxxxxx shall make the corresponding
milestone payment to Genaissance in United States dollars by bank
check or wire transfer.
W. A new sentence is hereby added to the end of Section 4.8.1 (a) Other
Drug Products, which reads as follows:
It is agreed that Drug Products that arise from or relate to HAP
Marker Combinations or HAP Marker Associations discovered in the
[**]Research Project or the [**]Research Project will be excluded from
payment of any [**] for Drug Products.
X. A new sentence is hereby added to the end of Section 4.8.2 (a) Other
Drug Products, which reads as follows:
It is agreed that Drug Products that arise from or relate to HAP
Marker Combinations or HAP Marker Associations discovered in the
[**]Research Project or the [**]Research Project will be excluded from
payment of any [**] for Drug Products.
Y. Section 5.1.3 is hereby amended to read as follows:
5.1.3 OWNERSHIP OF HAP(TM) MARKER ASSOCIATIONS AND HAP(TM)
MARKER COMBINATIONS. Genaissance shall have sole ownership of all
right, title and interest in all HAP Marker Associations and all HAP
Marker Association Patent Rights. Xxxxxxx shall disclose to
Genaissance any HAP Marker Associations from a Research Project
discovered solely by employees of Xxxxxxx or others acting on behalf
of Xxxxxxx and such HAP Marker Associations shall be treated as the
Confidential Information of Genaissance. Xxxxxxx shall execute and
deliver, without charge to Genaissance, assignment of all its right,
title and interest in and to HAP Marker Associations to Genaissance
subject to Xxxxxxx'x right to use the HAP Marker Associations and HAP
Marker Combinations pursuant to the terms of this Agreement.
3. REPRESENTATIONS AND WARRANTIES. Each party hereby represents and warrants
to the other that it has full authority and power to enter into this Amendment,
that it has secured any and all necessary approvals, permits or consents deemed
necessary or advisable for the consummation of the transactions contemplated
hereby and that upon execution by such party, this Amendment shall immediately
be a valid and binding obligation of such party, enforceable against it in
accordance with its terms.
4. EFFECT OF AMENDMENTS. On and after the Effective Date hereof, the Agreement
shall be deemed to be amended and supplemented as hereinabove set forth, as
fully and with the same force and effect as if the amendments set forth herein
had originally been set forth in the Agreement.
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5. LIMITATIONS. Except as amended and supplemented hereby, all the terms and
provisions of the Agreement shall remain unchanged and in full force and effect.
No alteration or amendment to this Amendment shall be binding on any party
hereto unless reduced to writing signed by both parties.
6. COUNTERPARTS. This Amendment may be executed in two or more counterparts,
all such counterparts taken together shall constitute the original thereof.
7. FACSIMILE COPIES. For purposes of this Amendment a signed facsimile copy
shall have the same force and effect as an original signed agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK.]
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IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the date
first above written.
GENAISSANCE PHARMACEUTICALS, INC. XXXXXXX PHARMACEUTICA, N.V.
By: /s/ Xxxxxx X. Xxxxx By: /s/ X.X. Xxxxxxx
------------------------------ ---------------------------------
Name: Xxxxxx X. Xxxxx Name: X.X. Xxxxxxx, M.D.
Vice President
Title: Executive Vice President and Title: Xxxxxxx & Xxxxxxx Pharmaccutical
Chief Technology Officer R & D
Date: 25 November 2002 Date: 20 Nov 2002
By:
------------------------------
Name:
------------------------------
Title:
------------------------------
Date:
------------------------------
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EXHIBIT H3
[**] RESEARCH PROJECT
To be Agreed by Xxxxxxx and Genaissance
1
EXHIBIT H4
[**] RESEARCH PROJECT
To be Agreed by Xxxxxxx and Genaissance
2
EXHIBIT H5
[**] RESEARCH PROJECT
To be Agreed by Xxxxxxx and Genaissance
3
EXHIBIT J
GENOTYPING PROJECTS
To Be Agreed by Xxxxxxx and Genaissance
4
EXHIBIT J1
[**] GENOTYPING PROJECT
To be Agreed by Xxxxxxx and Genaissance
5
