EXHIBIT 10.21
[CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE
BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.]
LICENSE AGREEMENT
BETWEEN
HUMAN GENOME SCIENCES, INC.
AND
VICAL INCORPORATED
FEBRUARY 24, 2000
TABLE OF CONTENTS
1 BACKGROUND 1
2 DEFINITIONS 2
3 GRANTS AND COVENANTS 7
4 HGS PRODUCTS 11
5 VICAL PRODUCTS 13
6 MILESTONES AND ROYALTIES 16
7 TECHNOLOGY TRANSFER 20
8 PRODUCT DEVELOPMENT 21
9 CONFIDENTIALITY 23
10 PATENT PROSECUTION AND LITIGATION 25
11 STATEMENTS AND REMITTANCES 28
12 TERM AND TERMINATION 29
13 WARRANTIES AND REPRESENTATIONS 31
14 INDEMNIFICATION 33
15 FORCE MAJEURE 35
16 DISPUTE RESOLUTION 35
17 SEPARABILITY 36
18 ENTIRE AGREEMENT 36
19 NOTICES 37
20 ASSIGNMENT AND CHANGE OF CONTROL 38
21 COUNTERPARTS 38
22 WAIVER 38
23 INDEPENDENT RELATIONSHIP 39
24 FURTHER ACTIONS 39
i
LICENSE AGREEMENT
THIS AGREEMENT ("Agreement"), dated as of the 24th of February 2000 (the
"Effective Date"), is entered into by Human Genome Sciences, Inc. ("HGS"), a
Delaware corporation, having a place of business at 0000 Xxx Xxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxx 00000, and Vical Incorporated ("VICAL"), a Delaware
corporation, having a place of business at 0000 Xxxxx Xxxxxx Xxxxx, Xxx Xxxxx,
Xxxxxxxxxx 00000.
1 BACKGROUND
1.1 HGS is in possession of certain human gene sequence information and has
the ability and desire to develop and commercialize and to have
developed and commercialized gene therapy products based on that
sequence information.
1.2 VICAL is in possession of certain gene therapy delivery methods and has
the ability and desire to develop and commercialize and to have
developed and commercialized gene therapy products based on those
delivery methods.
1.3 Vascular Genetics Inc. ("VGI") has an exclusive license from HGS for
the use of the gene Vascular Endothelial Growth Factor-2 ("VEGF-2") in
the gene therapy treatment of vascular diseases. HGS holds a
significant equity interest in VGI.
1.4 HGS, VICAL, and VGI have agreed in an Investment Agreement, dated
February 24, 2000 (the "Investment Agreement") to undertake a series of
transactions in which (1) VGI will receive a license from VICAL for the
use of VICAL's gene therapy delivery methods in conjunction with
VEGF-2; (2) HGS will receive a license from VICAL for the use of
certain VICAL technology with respect to certain genes; (3) VICAL will
receive a license from HGS for the use of certain genes as gene therapy
products; (4) VICAL will receive an equity interest in VGI, which VGI
will have certain rights to redeem; and (5) HGS will receive additional
equity in VGI and will have returned to it by VGI rights to certain
genes licensed to VGI by HGS.
1.5 To effect this series of transactions pursuant to the terms and
conditions of the Investment Agreement, this Agreement is being
simultaneously executed with (1) a license agreement between VICAL and
VGI; (2) a second amendment to the license agreement between HGS and
VGI; (3) certain other agreements, all as set forth in the Investment
Agreement.
2 DEFINITIONS.
2.1 "AFFILIATE" shall mean any individual or entity directly or indirectly
controlling, controlled by or under common control with, the specified
individual or entity. For purposes of this Agreement, the direct or
indirect ownership of fifty percent (50%) or more of the outstanding
voting securities of an entity, or the right to receive fifty (50%) or
more of the profits or earnings of an entity shall be deemed to
constitute control. Such other relationship as in fact gives such
individual or entity the power or ability to control the management,
business and affairs of an entity shall also constitute control.
2.2 "CONFIDENTIAL INFORMATION" shall mean, with respect to a party, all
information (and all tangible and intangible embodiments thereof),
which is owned or controlled by such party, is disclosed by such party
to the other party pursuant to this Agreement and (if disclosed in
writing or other tangible medium) is marked or identified as
confidential at the time of disclosure to the receiving party or (if
otherwise disclosed) is identified as confidential at the time of
disclosure to the receiving party and described as such in writing
within thirty (30) days after such disclosure. Notwithstanding the
foregoing, CONFIDENTIAL INFORMATION of a party shall not include
information which, and only to the extent, the receiving party can
establish by written documentation (a) has been publicly known prior to
disclosure of such information by the disclosing party to the receiving
party, (b) has become publicly known, without fault on the part of the
receiving party, subsequent to disclosure of such information by the
disclosing party to the receiving party, (c) has been received by the
receiving party at any time from a source, other than the disclosing
party, rightfully having possession of and the right to disclose such
information free of confidentiality obligations, (d) has been otherwise
known by the receiving party free of confidentiality obligations prior
to disclosure of such information by the disclosing party to the
receiving party, or (e) has been independently developed by
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employees or others on behalf of the receiving party without access to
or use of such information disclosed by the disclosing party to the
receiving party.
2.3 "CYTOFECTIN DELIVERY TECHNOLOGY" shall mean all patentable or
unpatentable inventions, discoveries, technology and information of any
type whatsoever, including without limitation compositions, methods,
processes, confidential information, technical information, knowledge,
experience and know-how regarding the use of cytofectins (including
cationic lipids) in the delivery of GENES into a patient for the
treatment or prevention of one or more diseases or conditions; in each
case which is owned by or licensed to VICAL on the Effective Date or
during the term of this Agreement, all to the extent and only to the
extent that VICAL now has or hereafter will have the right to grant
licenses, immunities or other rights thereunder.
2.4 "DIRECT INJECTION TECHNOLOGY" shall mean all patentable or unpatentable
inventions, discoveries, technology and information of any type
whatsoever, including without limitation compositions, methods,
processes, confidential information, technical information, knowledge,
experience and know-how regarding the direct injection of GENES
(including plasmid DNA-based delivery technology) into a patient to
cause the IN VIVO expression of a desired protein, thereby effecting
delivery of such protein, to a patient for the treatment or prevention
of one or more diseases or conditions; in each case which is owned by
or licensed to VICAL on the Effective Date or during the term of this
Agreement, all to the extent and only to the extent that VICAL now has
or will have during the term of this Agreement the right to grant
licenses, immunities or other rights thereunder.
2.5 "DNA PROCESS TECHNOLOGY" shall mean all patentable or unpatentable
inventions, discoveries, technology and information of any type
whatsoever, including without limitation compositions, methods,
processes, confidential information, technical information, knowledge,
experience and know-how regarding technologies related to the
manufacture and processing of plasmid DNA for human use; in each case ,
which is owned by or licensed to VICAL on the Effective Date or during
the term of this Agreement, all to the extent and only to the extent
that VICAL now has or will have during the term of this Agreement the
right to grant licenses, immunities or other rights
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thereunder.
2.6 "EXCLUSIVE HGS PRODUCT" means any product or part thereof (a) the
manufacture, use or sale of which is covered by an VICAL PATENT or is
otherwise based on, uses or incorporates the VICAL TECHNOLOGY and (b)
comprises an HGS RESEARCH GENE as to which HGS has exercised an option
under Paragraph 3.2 and been granted a license under Paragraph 4.3.
2.7 "EXCLUSIVE VICAL PRODUCT" means any product or part thereof (a) the
manufacture, use, or sale of which is covered by a HGS PATENT or is
otherwise based on, uses or incorporates the HGS TECHNOLOGY, and (b)
comprises a VICAL RESEARCH GENE as to which VICAL has exercised an
option under Paragraph 3.6 and been granted a license under Paragraph
5.4.
2.8 "FIELD" shall mean the intervention, treatment and/or prevention of a
disease or disorder in humans by GENE THERAPY.
2.9 "GENE" shall mean a human nucleotide sequence, including DNA, RNA and
complementary and reverse complementary nucleotide sequences thereto,
whether coding or non-coding and whether intact or a fragment.
2.10 "GENE THERAPY" shall mean the treatment or prevention of a disease, or
remedying a gene deficiency of humans by genetic modification of
somatic cells (IN VIVO or EX VIVO) with DNA whereby an active
transcription process results in the expression of a protein or
oligo(poly)nucleotide encoded by said DNA in a human.
2.11 "HGS DATABASES" shall mean all data and information which during the
term of this Agreement is owned by HGS or to which HGS has the right to
grant access, regarding (i) xxxxxxxx xxxx with respect to genetic
material (and the corresponding clones) and expression products
thereof, (ii) information on biological function of such genetic
material and expression products, and (iii) clones, cell lines and
vectors.
2.12 "HGS IMPROVEMENTS" shall mean all patentable or unpatentable
inventions, discoveries, or other technology regarding VICAL RESEARCH
GENES or the protein(s)
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encoded thereby or the use of either of the foregoing, but expressly
excluding a formulation or combination of a GENE and the delivery
vehicle for such GENE, made or conceived by VICAL solely or jointly
with others during the term of this Agreement.
2.13 "HGS PATENT(S)" shall mean (a) all patent applications filed in any
country before or after the Effective Date; (b) all patents that have
issued or in the future issue from any of the foregoing patent
applications, including without limitation, utility and design patents
and certificates of invention; and (c) all continuations,
continuations-in-part, divisionals, additions, reissues, renewals,
re-examinations or extensions, or SPCs to any such patents and patent
applications; in each case which during the term of this Agreement are
or become owned by HGS or to which HGS otherwise has, now or in the
future, the right to grant licenses and which claim in whole or in part
GENES, HGS TECHNOLOGY or the use thereof in the FIELD.
2.14 "HGS RESEARCH GENE" shall mean a GENE identified by HGS pursuant to
Paragraph 7.3.
2.15 "HGS TECHNOLOGY" shall mean (a) xxxxxxxx xxxx with respect to human DNA
(and the corresponding clones) and expression products, (b) information
on biological function of GENES, and (c) HGS clones, cell lines and
vectors and all related information and data which during the term of
this Agreement, are owned by HGS or to which HGS otherwise has the
right to grant licenses, immunities or other rights thereunder.
2.16 "IND" shall mean an Investigational New Drug application filed with the
Food and Drug Administration in the United States, or any similar
filing with any foreign regulatory authority, to commence human
clinical testing of a PRODUCT in any country.
2.17 "NET SALES" shall mean, with respect to a PRODUCT, the gross sales
price invoiced by the seller (calculated on a PRODUCT by PRODUCT basis)
to THIRD PARTIES that are not (sub)licensees (except as set forth
below), less normal and customary deductions actually paid or accrued
by the seller for (i) normal and customary trade, cash and quality
credits, discounts, refunds or government rebates; (ii) credits for
claims, allowances or returns; retroactive price reductions;
chargebacks or the like; and (iii) sales taxes, duties and other
government charges (including value added tax), but excluding what is
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commonly known as income taxes. NET SALES shall not include sales among
the seller, its (sub)licensees and their respective AFFILIATES for
resale, provided that NET SALES shall include the amounts invoiced by
the seller, its sublicensees and their respective AFFILIATES to THIRD
PARTIES on the resale of such PRODUCT. Sales between or among a party,
its (sub)licensees and their respective AFFILIATES shall be included
within NET SALES only if such purchaser is an end-user of such PRODUCT.
2.18 "PRODUCT(S)" shall mean EXCLUSIVE VICAL PRODUCT(S) and EXCLUSIVE HGS
PRODUCT(S).
2.19 "RESEARCH PLAN" shall mean a plan for research and development of a
PRODUCT in the FIELD, which includes, at a minimum, scientific data,
research and development efforts, and research and development
milestones.
2.20 "RESEARCH TERM" shall mean the period beginning on the Effective Date
and ending on September 30, 2004.
2.21 "SB" shall mean SmithKline Xxxxxxx Corporation and/or SmithKline
Xxxxxxx p.l.c., as defined in the SB/HGS LICENSE AGREEMENT.
2.22 "SB/HGS LICENSE AGREEMENT" shall mean the SB/HGS License Agreement
dated June 28, 1996 between SmithKline Xxxxxxx Corporation, SmithKline
Xxxxxxx p.l.c. and Human Genome Sciences, Inc., as the same may be
amended from time to time.
2.23 "SP" shall mean Schering Corporation and/or Schering Plough Ltd., as
defined in the SP/HGS GENE THERAPY LICENSE AGREEMENT.
2.24 "SP/HGS GENE THERAPY LICENSE AGREEMENT" shall mean the Gene Therapy
Collaboration and License Agreement between HGS and SP, dated June 28,
1996.
2.25 "SPC" shall mean a right based upon an underlying patent such as a
Supplementary Protection Certificate.
2.26 "THIRD PARTY" shall mean any party other than HGS or VICAL or an
AFFILIATE of
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VICAL or HGS.
2.27 "VICAL IMPROVEMENTS" shall mean all patentable or unpatentable
inventions, discoveries or other technology regarding VICAL TECHNOLOGY,
but expressly excluding a formulation or combination of a GENE and the
delivery vehicle for such GENE, made or conceived by HGS solely or
jointly with others during the term of this Agreement, and which
resulted from the use of VICAL TECHNOLOGY.
2.28 "VICAL PATENT(S)" shall mean (a) all patent applications filed in any
country before or after the Effective Date; (b) all patents that have
issued or in the future issue from any of the foregoing patent
applications, including without limitation, utility and design patents
and certificates of invention, further including but not limited to
those patents listed in Appendix A; and (c) all continuations,
continuations-in-part, divisional, additions, reissues, renewals,
re-examinations or extensions, or SPCs to any such patents and patent
applications; in each case which during the term of this Agreement are
or become owned by VICAL or to which VICAL otherwise has, now or in the
future, the right to grant licenses and which claim in whole or in part
VICAL TECHNOLOGY or the use thereof in the FIELD.
2.29 "VICAL RESEARCH GENE" shall mean a GENE identified by VICAL pursuant to
Paragraph 7.2.
2.30 "VICAL TECHNOLOGY" shall mean (a) DIRECT INJECTION TECHNOLOGY, (b)
CYTOFECTIN DELIVERY TECHNOLOGY, and (c) DNA PROCESS TECHNOLOGY.
3 GRANTS AND COVENANTS
HGS PRODUCTS
3.1 Subject to the terms and conditions of this Agreement, VICAL grants to
HGS a non-exclusive, non-transferable, worldwide license (without the
right to grant sublicenses) under VICAL TECHNOLOGY and VICAL PATENTS to
perform research and preclinical development in the FIELD during the
RESEARCH TERM using HGS RESEARCH GENES.
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3.2 Subject to the terms and conditions of this Agreement, VICAL hereby
grants to HGS non-exclusive, non-transferable options to obtain
licenses under Paragraph 3.3 for up to three (3) HGS RESEARCH GENES
exercisable during the RESEARCH TERM of this Agreement in accordance
with the provisions of Article 4.
3.3 Subject to the terms and conditions of this Agreement, with respect to
EXCLUSIVE HGS PRODUCTS directed to an HGS RESEARCH GENE for which HGS
has exercised an option under Paragraph 3.2 and VICAL is obligated to
grant a license pursuant to Paragraph 4.3, VICAL grants to HGS an
exclusive worldwide license (with the right to grant sublicenses) under
VICAL TECHNOLOGY and VICAL PATENTS to research, develop, make, have
made, use, import, export, offer to sell and sell such EXCLUSIVE HGS
PRODUCTS in the FIELD.
3.4 For any sublicense granted by HGS to an AFFILIATE or THIRD PARTY
pursuant to the provisions of Paragraph 3.3, HGS shall provide VICAL
with a copy of each sublicense granted hereunder promptly after
executing the same; provided, however, that HGS shall have the right to
redact any confidential terms from the copy provided to VICAL. Any such
sublicense shall be subject and subordinate to the terms and conditions
of this Agreement, and HGS shall remain responsible for all payments
due to VICAL.
VICAL PRODUCTS
3.5 Subject to the terms and conditions of this Agreement, HGS grants to
VICAL a non-exclusive, non-transferable, worldwide license (without the
right to grant sublicenses), under HGS TECHNOLOGY and HGS PATENTS to
perform research and preclinical development in the FIELD during the
RESEARCH TERM using VICAL RESEARCH GENES.
3.6 Subject to the terms and conditions of this Agreement, HGS hereby
grants to VICAL non-exclusive, non-transferable options to obtain
licenses under Paragraph 3.7 for up to three (3) VICAL RESEARCH GENES
exercisable during the RESEARCH TERM of this Agreement in accordance
with the provisions of Article 5.
3.7 Subject to the terms and conditions of this Agreement, with respect to
EXCLUSIVE
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VICAL PRODUCTS directed to a VICAL RESEARCH GENE for which VICAL has
exercised an option under Paragraph 3.6 and HGS is obligated to grant
a license pursuant to Paragraph 5.3, HGS grants to VICAL an exclusive
worldwide license (with the right to grant sublicenses) under HGS
TECHNOLOGY and HGS PATENTS to research, develop, make, have made, use,
import, export, offer to sell and sell such EXCLUSIVE VICAL PRODUCTS
in the FIELD.
3.8 For any sublicense granted by VICAL to an AFFILIATE or THIRD PARTY
pursuant to the provisions of Paragraph 3.7, VICAL shall provide HGS
with a copy of each sublicense granted hereunder promptly after
executing the same; provided, however, that VICAL shall have the right
to redact any confidential terms from the copy provided to HGS. Any
such sublicense shall be subject and subordinate to the terms and
conditions of this Agreement, and VICAL shall remain responsible for
all payments due to HGS.
MISCELLANEOUS
3.9 During and after the RESEARCH TERM, VICAL agrees to use HGS TECHNOLOGY
and HGS PATENTS only as licensed and permitted hereunder. During and
after the RESEARCH TERM, HGS agrees to use VICAL TECHNOLOGY and VICAL
PATENTS only as licensed and permitted hereunder.
3.10 The rights and licenses granted to HGS by VICAL are sublicensable
and/or transferable by HGS to a THIRD PARTY only with respect to a
specific EXCLUSIVE HGS PRODUCT and only in accordance with the
provisions of this Agreement. The rights and licenses granted to VICAL
by HGS are licensable and/or transferable by VICAL to a THIRD PARTY
only with respect to a specific EXCLUSIVE VICAL PRODUCT and only in
accordance with the provisions of this Agreement.
3.11 Notwithstanding anything to the contrary in this Agreement, HGS shall
not grant any rights or license to a THIRD PARTY with respect to an
EXCLUSIVE HGS PRODUCT unless HGS has first demonstrated IN VIVO
biological activity for the EXCLUSIVE HGS PRODUCT in a relevant animal
model. VICAL shall not grant any rights or license to a THIRD PARTY
with respect to an EXCLUSIVE VICAL PRODUCT unless VICAL has first
demonstrated IN VIVO biological activity for the EXCLUSIVE VICAL
PRODUCT in
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a relevant animal model. Such evidence of IN VIVO biological activity
must be statistically different (p < 0.05) from control for at least
one data point.
3.12 Notwithstanding anything to the contrary herein, HGS shall own all
right, title and interest in and to the HGS IMPROVEMENTS and all
intellectual property rights therein and thereto. VICAL hereby
irrevocably assigns, transfers and conveys to HGS all right, title and
interest in and to the HGS IMPROVEMENTS and all intellectual property
rights therein and thereto. VICAL shall take, and shall cause its
AFFILIATES to take any and all actions and execute and deliver (or
cause to be executed or delivered) any and all documents reasonably
requested by HGS, at HGS' expense, in order to effect the foregoing
assignment.
3.13 HGS hereby grants VICAL a non-exclusive, royalty-free, perpetual,
worldwide, sublicensable license to HGS IMPROVEMENTS and the claims of
any HGS PATENT covering such HGS IMPROVEMENTS but only to the extent
that such claims cover HGS IMPROVEMENTS.
3.14 Notwithstanding anything to the contrary herein, VICAL shall own all
right, title and interest in and to the VICAL IMPROVEMENTS and all
intellectual property rights therein and thereto. HGS hereby
irrevocably assigns, transfers and conveys to VICAL all right, title
and interest in and to the VICAL IMPROVEMENTS and all intellectual
property rights therein and thereto. HGS shall take, and shall cause
its AFFILIATES to take any and all actions and execute and deliver (or
cause to be executed or delivered) any and all documents reasonably
requested by VICAL, at VICAL's expense, in order to effect the
foregoing assignment.
3.15 VICAL hereby grants HGS a non-exclusive, royalty-free, perpetual,
worldwide, sublicensable license to VICAL IMPROVEMENTS and the claims
of any VICAL PATENT covering such VICAL IMPROVEMENTS, but only to the
extent that such claims cover VICAL IMPROVEMENTS.
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3.16 Notwithstanding anything to the contrary herein, during the period
commencing upon the Effective Date and ending ***, HGS shall not
request and VICAL shall not grant to HGS any license rights regarding
GENES encoding ***.
3.17 No rights, other than those expressly set forth in this Agreement, are
granted to HGS or VICAL hereunder, and no additional rights shall be
granted to VICAL or HGS by implication, estoppel or otherwise.
4 HGS PRODUCTS
4.1 If HGS desires to exercise an option under Paragraph 3.2 for an HGS
RESEARCH GENE, HGS shall do so by submitting to VICAL a written notice
that describes the HGS RESEARCH GENE for which HGS seeks an exclusive
license to use VICAL TECHNOLOGY and VICAL PATENTS. Such notice shall
include the HGS Clone ID Number, the common name of such GENE, the
amino acid sequence encoded by the GENE, and any other publicly known
names of the GENE or the amino acid sequence.
4.2 VICAL shall grant an exclusive license pursuant to Paragraph 3.3 to the
HGS RESEARCH GENE identified in such notice provided that (1) VICAL has
not previously granted a license to a THIRD PARTY with respect to the
identified GENE or essentially the same GENE; or (2) VICAL has not
previously begun an active gene therapy program on such GENE or
essentially the same gene. For the purposes of this Agreement the term
"essentially the same" shall mean that the sequence of nucleotides
comprising the GENE is at least *** homologous to such GENE. In the
event that VICAL indicates to HGS that VICAL has previously begun a
program to research and/or develop a product in the FIELD which
utilizes, comprises, or is based on such GENE or essentially the same
GENE, within sixty (60) days thereafter HGS shall have the right to
notify VICAL that HGS at its cost and expense will have an independent
THIRD PARTY reasonably acceptable to VICAL inspect VICAL's records with
respect thereto solely for the purpose of verifying that VICAL has
previously begun such research and development. VICAL
____________
*** Confidential material redacted and separately filed with the Commission.
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shall permit such independent THIRD PARTY to effect such inspection
within a reasonable time after such notification provided that such
THIRD PARTY signs an agreement of confidentiality acceptable to VICAL
which includes a covenant that the only information which will be
provided to HGS is whether or not VICAL has in fact begun such research
and/or development.
4.3 Within thirty (30) days after receipt of a notice pursuant Paragraph
4.1, VICAL shall notify HGS in writing if VICAL does not have the right
to grant HGS the license under Paragraph 3.3 for such GENE. Unless
VICAL timely notifies HGS in writing that it does not have such a
right, VICAL hereby grants to HGS the exclusive license under Paragraph
3.3 for EXCLUSIVE HGS PRODUCTS directed to such GENE.
4.4 Following a grant to HGS under Paragraph 4.3 above, HGS shall not
exercise its option for its second or third GENE, as the case may be,
until the earlier of (a) the date on which HGS has granted to VICAL the
first or second, as the case may be, exclusive license pursuant to
Paragraph 3.7 for a GENE; or (b) the date *** after the date on which
VICAL has granted to HGS its immediately preceding exclusive license
pursuant to Paragraph 3.3 (the "HGS Holding Period"); provided,
however, if VICAL receives written notice pursuant to Paragraph 5.2 or
5.4 that a GENE requested by VICAL is not available, the HGS Holding
Period shall continue until the later of (i) the expiration of the ***
described in clause (b) above, and (ii) the earlier of (A) the date ***
after the date on which VICAL receives the latest written notice from
HGS pursuant to Paragraph 5.2 or 5.4, and (B) the date *** after the
expiration of the *** described in clause (b) above.
4.5 Within thirty (30) days of the grant of each license under Paragraph
3.3, HGS shall provide VICAL with a RESEARCH PLAN for each HGS RESEARCH
GENE for which license rights are granted.
4.6 HGS will have the sole responsibility for development and
commercialization of EXCLUSIVE HGS PRODUCTS.
____________
*** Confidential material redacted and separately filed with the Commission.
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4.7 VICAL agrees not to grant to any THIRD PARTY any rights or licenses in
or to an EXCLUSIVE HGS PRODUCT or to the use of VICAL TECHNOLOGY or
VICAL PATENTS with respect to essentially the same GENE which is
encompassed by such EXCLUSIVE HGS PRODUCT.
4.8 HGS may not exercise an option to obtain an exclusive license under
Paragraph 3.3 for EXCLUSIVE HGS PRODUCTS directed to more than three
(3) GENES during the term of this Agreement.
4.9 During the term of this Agreement and for a period of two (2) years
thereafter, HGS shall keep complete and accurate records of its
research and development activities conducted under this Agreement
regarding EXCLUSIVE HGS PRODUCTS and the results thereof. Within thirty
(30) days after the end of each calendar year during the term of this
Agreement, HGS shall prepare and provide VICAL with a reasonably
detailed written report of such activities and results through such
date.
5 VICAL PRODUCTS
5.1 If VICAL desires to exercise an option under Paragraph 3.6 for a VICAL
RESEARCH GENE, VICAL may do so by submitting to HGS a written notice
that describes the GENE for which VICAL seeks an exclusive license.
Such notice shall include the HGS Clone ID Number, the common name of
the GENE, the amino acid sequence encoded by the GENE, and any other
publicly known names of the GENE or the amino acid sequence.
5.2 HGS shall grant an exclusive license pursuant to Paragraph 3.7 to the
GENE identified in such notice provided that (1) HGS has not previously
granted a license to a THIRD PARTY with respect to such GENE or
essentially the same GENE; (2) the GENE is not directed to a
therapeutic protein that HGS has obtained exclusive rights to pursuant
to the SB/HGS LICENSE AGREEMENT and similar collaboration agreements;
(3) HGS has not previously begun an active gene therapy program on the
GENE or essentially the same GENE; or (4) SP has not exercised its
option as described in Paragraph 5.3. For the purposes of this
Agreement the term "essentially the same" shall mean that the sequence
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of nucleotides comprising the GENE incorporated in a product for GENE
THERAPY licensed to a THIRD PARTY, or under development by HGS, is at
least *** homologous to such GENE. In the event that HGS indicates to
VICAL that HGS has previously begun a program to research and/or
develop a product in the FIELD which utilizes, comprises or is based on
such GENE or essentially the same GENE, within sixty (60) days
thereafter VICAL shall have the right to notify HGS that VICAL at its
cost and expense will have an independent THIRD PARTY reasonably
acceptable to HGS inspect HGS' records with respect thereto solely for
the purpose of verifying that HGS has previously begun such research
and development. HGS shall permit such independent THIRD PARTY to
effect such inspection within a reasonable time after such notification
provided that such THIRD PARTY signs an agreement of confidentiality
acceptable to HGS which includes a covenant that the only information
which will be provided to VICAL is whether or not HGS has in fact begun
such research and/or development.
5.3 Under the terms of the SP/HGS GENE THERAPY LICENSE AGREEMENT, HGS may
not license a GENE to VICAL without first notifying SP and offering SP
the right to license such GENE. SP has the right to exercise its option
to such GENE within thirty (30) days after such notice from HGS.
Accordingly, upon written notice from VICAL pursuant to Section 5.1 of
its intent to exercise its option to a GENE, and if such GENE would
otherwise be available for licensing to VICAL except for the SP option,
HGS within ten (10) business days shall notify SP in writing that HGS
intends to license the GENE to a THIRD PARTY. Such notice shall not
identify VICAL as the THIRD Party. If SP fails to exercise the option
within the thirty (30) day period, HGS shall grant an exclusive license
to VICAL for the EXCLUSIVE VICAL PRODUCT.
5.4 Within ten (10) days after expiration of the SP option period described
in Paragraph 5.3, HGS shall notify VICAL in writing if HGS does not
have the right to grant VICAL the license under Paragraph 3.7 for such
GENE. Unless HGS timely notifies VICAL in writing that it does not have
such a right, HGS hereby grants to VICAL the exclusive
____________
*** Confidential material redacted and separately filed with the Commission.
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license under Paragraph 3.7 for EXCLUSIVE VICAL PRODUCTS directed to
such GENE.
5.5 Following a grant to VICAL under Paragraph 5.4 above, VICAL shall not
exercise its option for its second or third GENE, as the case may be,
until the earlier of (a) the date on which VICAL has granted to HGS the
first or second, as the case may be, exclusive license pursuant to
Paragraph 3.3 for a GENE; or (b) the date *** after the date on which
HGS has granted to VICAL its immediately preceding exclusive license
pursuant to Paragraph 3.7 (the "VICAL Holding Period"); provided,
however, if HGS receives written notice pursuant to Paragraph 4.2 or
4.3 that a GENE requested by HGS is not available, the VICAL Holding
Period shall continue until the later of (i) the expiration of the ***
described in clause (b) above, and (ii) the earlier of (A) the date ***
after the date on which HGS receives the latest written notice from
VICAL pursuant to Paragraph 4.2 or 4.3, and (B) the date *** after the
expiration of the *** described in clause (b) above.
5.6 Within thirty (30) days of the grant of the license under Paragraph 3.7
VICAL shall provide HGS with a RESEARCH PLAN for each VICAL RESEARCH
GENE for which license rights are granted.
5.7 VICAL will have the sole responsibility for development and
commercialization of EXCLUSIVE VICAL PRODUCTS.
5.8 HGS agrees not to grant to any THIRD PARTY any rights or licenses in or
to an EXCLUSIVE VICAL PRODUCT or to the use of HGS TECHNOLOGY or HGS
PATENTS in the FIELD with respect to essentially the same GENE which is
encompassed by such EXCLUSIVE VICAL PRODUCT.
5.9 VICAL may not exercise an option to obtain an exclusive license under
Paragraph 3.6 for EXCLUSIVE VICAL PRODUCTS directed to more than three
(3) GENES during the term of this Agreement.
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*** Confidential material redacted and separately filed with the Commission.
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5.10 During the term of this Agreement and for a period of two (2) years
thereafter, VICAL shall keep complete and accurate records of its
research and development activities conducted under this Agreement
regarding EXCLUSIVE VICAL PRODUCTS and the results thereof. Within
thirty (30) days after the end of each calendar year during the term of
this Agreement, VICAL shall prepare and provide HGS with a reasonably
detailed written report of such activities and results through such
date.
6 MILESTONES AND ROYALTIES
EXCLUSIVE HGS PRODUCT
6.1 Within thirty (30) days of the granting by VICAL of an exclusive
license for each EXCLUSIVE HGS PRODUCT, HGS shall pay to VICAL the sum
of ***.
6.2 For the second and third EXCLUSIVE HGS PRODUCTS for which HGS obtains a
license under Paragraph 3.3, but not for the first such EXCLUSIVE HGS
PRODUCT, HGS shall pay to VICAL a milestone payment of *** upon start
of a Phase III clinical trial. Such milestone payment shall be due and
payable within thirty (30) days after the start of the trial, which for
the purpose of this Paragraph 6.2 shall be the date the first patient
is enrolled in the trial. In the event that no Phase III clinical trial
is initiated prior to submission of an application for regulatory
approval (e.g., a New Drug Application or a Biological License
Application) of the PRODUCT, such milestone payment shall be due on the
date such submission is submitted to the appropriate regulatory
authority. The milestone payments provided in this Paragraph 6.2 shall
only be made once for each EXCLUSIVE HGS PRODUCT and shall not be made
in the case of improvements or modifications such as, but not limited
to, changed forms, formats, formulations, indications, processes or
protocols of an EXCLUSIVE HGS PRODUCT for which the payments were
previously made.
6.3 Subject to Paragraph 6.4, for each EXCLUSIVE HGS PRODUCT, HGS shall pay
to
____________
*** Confidential material redacted and separately filed with the Commission.
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VICAL a royalty of *** of NET SALES of the PRODUCT sold by HGS, and its
(sub)licensees and their respective AFFILIATES.
6.4 Royalty obligations under Paragraph 6.3, with respect to an EXCLUSIVE
HGS PRODUCT, shall terminate on a country-by-country basis and on an
EXCLUSIVE HGS PRODUCT by EXCLUSIVE HGS PRODUCT basis on the later of
(i) *** after first country-wide launch of such PRODUCT in such country
or (ii) expiration of the last to expire VICAL PATENT licensed to HGS
under this Agreement which covers the making, having made, importing,
exporting, offering to sell or using or selling of such PRODUCT in such
country.
6.5 In the event that HGS licenses an EXCLUSIVE HGS PRODUCT to a THIRD
PARTY, HGS shall pay VICAL a percentage of all revenues received under
the license for the EXCLUSIVE HGS PRODUCT, other than revenues received
as earned royalties, or payments for R&D services provided by HGS to
the licensee or monies to purchase equity in HGS at fair market value.
The percentage applied to such payments will vary according to the
development stage of the PRODUCT at the time such a license agreement
is entered into, as follows:
(a) If such PRODUCT is licensed to a THIRD PARTY prior to the
filing of an IND in the United States (or its foreign
equivalent in a Major Country), the percentage shall be ***;
(b) If such PRODUCT is licensed to a THIRD PARTY after the filing
of an IND in the United States (or its foreign equivalent in a
Major Country) but before the completion of an initial Phase
II(a) clinical trial, the percentage shall be ***;
(c) If such PRODUCT is licensed to a THIRD PARTY after completion
of an initial Phase II(a) clinical trial, the percentage shall
be ***.
____________
*** Confidential material redacted and separately filed with the Commission.
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EXCLUSIVE VICAL PRODUCT
6.6 Within thirty (30) days of the granting by HGS of an exclusive license
for each EXCLUSIVE VICAL PRODUCT, VICAL shall pay to HGS the sum of
***.
6.7 For the second and third EXCLUSIVE VICAL PRODUCTS for which VICAL
obtains a license under Paragraph 3.7, but not for the first such
EXCLUSIVE VICAL PRODUCT, VICAL shall pay to HGS a milestone payment ***
upon start of a Phase III clinical trial. Such milestone payment shall
be due and payable within thirty (30) days after the start of the
trial, which for the purpose of this Paragraph shall be the date the
first patient is enrolled in the trial. In the event that no Phase III
clinical trial is initiated prior to submission of an application for
regulatory approval (e.g., a New Drug Application or a Biological
License Application) of the PRODUCT, such milestone payment shall be
due on the date such submission is submitted to the appropriate
regulatory authority. The milestone payments provided in this Paragraph
6.7 shall only be made once for each EXCLUSIVE VICAL PRODUCT and shall
not be made in the case of improvements or modifications such as, but
not limited to, changed forms, formats, formulations, indications,
processes or protocols of an EXCLUSIVE VICAL PRODUCT for which the
payments were previously made.
6.8 Subject to Paragraph 6.9, for each EXCLUSIVE VICAL PRODUCT, VICAL shall
pay to HGS a royalty of *** of NET SALES of the PRODUCT sold by VICAL,
and its (sub)licensees and their respective AFFILIATES.
6.9 Royalty obligations under Paragraph 6.8, with respect to an EXCLUSIVE
VICAL PRODUCT, shall terminate on a country-by-country basis and on an
EXCLUSIVE VICAL PRODUCT by EXCLUSIVE VICAL PRODUCT basis on the later
of (i) *** after first country-wide launch of such PRODUCT in such
country or (ii) expiration of the last to expire HGS PATENT licensed to
VICAL under this Agreement which covers the making, having made,
importing, exporting, offering to sell or using or selling of such
____________
*** Confidential material redacted and separately filed with the Commission.
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PRODUCT in such country.
6.10 In the event that VICAL licenses an EXCLUSIVE VICAL PRODUCT to a THIRD
PARTY, VICAL shall pay HGS a percentage of all revenues received under
the license for the EXCLUSIVE VICAL PRODUCT, other than revenues
received as earned royalties, payments for R&D services provided by
VICAL to the licensee or monies to purchase equity in VICAL at fair
market value. The percentage applied to such payments will vary
according to the development stage of the PRODUCT at the time such
license agreement is entered into, as follows:
(a) If such PRODUCT is licensed to a THIRD PARTY prior to the
filing of an IND in the United States (or its foreign
equivalent in a Major Country), the percentage shall be ***;
(b) If such PRODUCT is licensed to a THIRD PARTY after the filing
of an IND in the United States (or its foreign equivalent in a
Major Country) but before the completion of an initial Phase
II(a) clinical trial, the percentage shall be ***;
(c) If such PRODUCT is licensed to a THIRD PARTY after completion
of an initial Phase II(a) clinical trial, the percentage shall
be ***.
MISCELLANEOUS
6.11 For purposes of this Article 6, (a) "Phase II(a) clinical trial" shall
mean an initial human clinical trial in a Major Country that is
intended to initially evaluate the effectiveness of a PRODUCT for a
particular indication or indications in patients with the disease or
indication under study, or that would otherwise satisfy requirements of
21 CRF 312.21(b); (b) "Phase III clinical trial" shall mean a human
clinical trial in a Major Country the results of which could be used as
pivotal to establish safety and efficacy of a PRODUCT as a basis for a
marketing approval application submitted to the U.S. FDA or a foreign
equivalent, or that would otherwise satisfy requirements of 21 CRF
312.21(c);
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*** Confidential material redacted and separately filed with the Commission.
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and, (c) "Major Country" shall mean the United States, any country in
the European Union, Canada or Japan.
6.12 If, at the time when any milestone payment listed in the applicable
Paragraph under this Article 6 with respect to a PRODUCT is due from a
party, such party has not paid all other milestone payments (if any)
previously listed in such Paragraph with respect to such PRODUCT, then
at such time such party shall pay all such unpaid milestone payments
(if any) previously listed in such Paragraph with respect to such
PRODUCT. If, at the time of the first commercial sale of a PRODUCT by a
party, its AFFILIATE or permitted licensee, such party has not paid all
milestone payments (if any) listed in the applicable Paragraph under
this Article 6 with respect to such PRODUCT, then at such time such
party shall pay all such unpaid milestone payments (if any) listed in
such Paragraph with respect to such PRODUCT.
6.13 The manner in which statements and remittances of royalty and other
payments are handled is as set forth in Article 11 hereof.
6.14 All payments to be made hereunder shall be by wire transfer of
immediately available funds to an account designated by VICAL or HGS,
whoever is to be the recipient of such funds.
7 TECHNOLOGY TRANSFER
7.1 To assist VICAL in the selection of three (3) GENES for exclusive
licensing pursuant to Paragraph 3.7, HGS scientists shall meet with
VICAL scientists to discuss therapeutic areas of interest to VICAL and
to develop criteria and search parameters for potential GENES of
interest to VICAL. Upon VICAL's request, HGS shall search the HGS
DATABASES for GENES that meet those criteria and parameters and will
provide VICAL with a list of the candidates resulting from such
searches.
7.2 VICAL shall have the right to identify a reasonable number of GENES
(***) as VICAL
____________
*** Confidential material redacted and separately filed with the Commission.
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RESEARCH GENES. These genes may be based on the candidates identified
pursuant to Paragraph 7.1 or may be independently identified by VICAL.
For each such VICAL RESEARCH GENE, HGS will provide VICAL to the extent
available all xxxxxxxx xxxx related to such GENE contained in the HGS
DATABASES and any HGS clones related to that GENE. HGS will be required
to furnish such data and clones only to the extent that HGS would be
able to grant VICAL an EXCLUSIVE LICENSE to such GENE pursuant to
Paragraph 3.7.
7.3 HGS shall have the right to identify a reasonable number of GENES (***)
as HGS RESEARCH GENES.
7.4 To assist HGS in the utilization of VICAL TECHNOLOGY, VICAL scientists
will meet with HGS scientists to discuss the application of VICAL
TECHNOLOGY to HGS RESEARCH GENES and will provide to HGS any know-how
or proprietary materials necessary for HGS to use the VICAL TECHNOLOGY
with respect to an HGS RESEARCH GENE in accordance with the research
license granted in Paragraph 3.1. VICAL will be required to furnish
such information only to the extent that VICAL would be able to grant
HGS an EXCLUSIVE LICENSE to such HGS RESEARCH GENE pursuant to
Paragraph 3.3.
7.5 Pursuant to Paragraphs 7.1 and 7.4, HGS and VICAL agree to make their
scientists reasonably available to the other.
8 PRODUCT DEVELOPMENT
8.1 VICAL shall use reasonable efforts to actively research, develop,
market, promote and sell each royalty bearing EXCLUSIVE VICAL PRODUCT.
8.2 During the term of this Agreement and for a period of five (5) years
thereafter, VICAL shall keep complete and accurate records of its
activities conducted under this Agreement regarding the development and
commercialization of EXCLUSIVE VICAL PRODUCTS
____________
*** Confidential material redacted and separately filed with the Commission.
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and the results thereof. Within thirty (30) days after the end of each
calendar year during the term of this Agreement, VICAL shall prepare
and provide HGS with a reasonably detailed written report of such
activities and results, through such date.
8.3 If at any time VICAL elects not to continue the development and
commercialization of an EXCLUSIVE VICAL PRODUCT, or fails to use
reasonable efforts to actively research, develop, market, promote and
sell each such PRODUCT as required by Paragraph 8.1, all relevant
licenses granted by HGS pursuant to this Agreement shall terminate.
8.4 HGS shall use reasonable efforts to actively research, develop, market,
promote and sell each royalty bearing EXCLUSIVE HGS PRODUCT.
8.5 During the term of this Agreement and for a period of five (5) years
thereafter, HGS shall keep complete and accurate records of its
activities conducted under this Agreement regarding the development and
commercialization of EXCLUSIVE HGS PRODUCTS and the results thereof.
Within thirty (30) days after the end of each calendar year during the
term of this Agreement, HGS shall prepare and provide VICAL with a
reasonably detailed written report of such activities and results,
through such date.
8.6 If at any time HGS elects not to continue the development and
commercialization of an EXCLUSIVE HGS PRODUCT, or fails to use
reasonable efforts to actively research, develop, market, promote and
sell each such PRODUCT as required by Paragraph 8.4 all relevant
licenses granted by VICAL pursuant to this Agreement shall terminate;
provided however, that if HGS is pursuing development and
commercialization of a gene therapy product not derived from VICAL
TECHNOLOGY, but directed to the same gene as the EXCLUSIVE HGS PRODUCT,
HGS shall have the option at its sole discretion to retain the relevant
VICAL licenses by paying to VICAL the milestones and royalties set
forth in Paragraph 6.1, on the development and sale of such non-VICAL
derived product.
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9 CONFIDENTIALITY
9.1 During the term of this Agreement and for a period of *** following the
expiration or earlier termination hereof, each party shall maintain in
confidence the CONFIDENTIAL INFORMATION of the other party, and shall
not disclose, use or grant the use of the CONFIDENTIAL INFORMATION of
the other party except on a need-to-know basis to such party's
AFFILIATES, directors, officers, employees, agents, independent
contractors and such party's THIRD PARTY licensors of intellectual
property rights (sub)licensed hereunder, and such party's consultants,
to the extent such disclosure is reasonably necessary in connection
with such party's activities as expressly authorized by this Agreement.
To the extent that disclosure to any person is authorized by this
Agreement, prior to disclosure, a party shall obtain written agreement
of such person to hold in confidence and not disclose, use or grant the
use of the CONFIDENTIAL INFORMATION of the other party except as
expressly permitted under this Agreement. Each party shall notify the
other party promptly upon discovery of any unauthorized use or
disclosure of the other party's CONFIDENTIAL INFORMATION. Upon the
expiration or earlier termination of this Agreement, each party shall
return to the other party all tangible items regarding the CONFIDENTIAL
INFORMATION of the other party and all copies thereof; provided,
however, that each party shall have the right to retain one (1) copy
for its legal files for the sole purpose of determining its obligations
hereunder.
9.2 All confidential information disclosed by one party to the other party
shall remain the intellectual property of the disclosing party. In the
event that a court or other legal or administrative tribunal, directly
or through an appointed master, trustee or receiver, assumes partial or
complete control over the assets of a party to this Agreement based on
the insolvency or bankruptcy of such party, the bankrupt or insolvent
party shall promptly notify the court or other tribunal (i) that
confidential information received from the other party under this
Agreement remains the property of the other party and (ii) of the
confidentiality obligations under this Agreement. In addition, the
bankrupt or insolvent
____________
*** Confidential material redacted and separately filed with the Commission.
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party shall, to the extent permitted by law, take all steps necessary
or desirable to maintain the confidentiality of the other party's
confidential information and to insure that the court, other tribunal
or appointee maintains such information in confidence in accordance
with the terms of this Agreement.
9.3 No public announcement or public disclosure concerning (i) the
existence of or terms of this Agreement, (ii) research and/or
discoveries made by one party, (iii) milestones achieved by one party,
or (iv) exercise by one party of rights and options granted under this
Agreement, shall be made, either directly or indirectly, by any other
party to this Agreement without prior written notice and, except as may
be legally required, or as may be legally required for a public
offering of securities, or as may be required for recording purposes,
without first obtaining the approval of the other party and agreement
upon the nature and text of such announcement, such agreement and/or
approval not to be unreasonably withheld. Except as otherwise required
by law, the party desiring to make any such public announcement or
public disclosure shall inform the other party of the proposed
announcement or disclosure at least five (5) business days prior to
public release, and shall provide the other party with a written copy
thereof, in order to allow such other party to comment upon such
announcement or disclosure. This Paragraph shall not apply to any
information in a public announcement or public disclosure that is
information essentially identical to that contained in a previous
public announcement or public disclosure agreed to pursuant to this
paragraph.
9.4 The confidentiality obligations under Paragraphs 9.1 and 9.2 shall not
apply to the extent that a party is required to disclose information by
applicable law, regulation or order of a governmental agency or a court
of competent jurisdiction; provided, however, that to the extent
practical such party (a) shall provide written notice thereof to the
other party and consult with the other party prior to such disclosure
with respect, thereto, and (b) shall provide the other party sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof, and provide reasonable assistance as requested in
connection therewith.
9.5 Both parties agree that all RESEARCH PLANS submitted by a party to the
other party
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pursuant to this Agreement shall be strictly confidential and that all
RESEARCH PLANS will not be utilized by or on behalf of the receiving
party for any purpose other than as authorized under this Agreement.
9.6 Each party hereto acknowledges that the remedy at law for breach by any
party of its obligations under this Section 9 is inadequate and that
each party shall be entitled to equitable remedies, including
injunctive relief, in the event of a breach by the other party.
9.7 The provisions of this Section 9 are in addition to an do not supercede
and are not superceded by similar provisions in any other agreements.
10 PATENT PROSECUTION AND LITIGATION
10.1 All right, title and interest to the VICAL TECHNOLOGY and all patent
rights and other intellectual property rights therein shall belong
solely to VICAL. VICAL shall have the sole right and responsibility for
the filing, prosecution and maintenance of patents and patent
applications directed thereto.
10.2 All right, title and interest to the HGS TECHNOLOGY and all patent
rights and other intellectual property rights therein shall belong
solely to HGS. HGS shall have the sole right and responsibility for the
filing, prosecution and maintenance of patents and patent applications
directed thereto.
10.3 With respect to any patent covering HGS IMPROVEMENTS or VICAL
IMPROVEMENTS that is a joint invention of both HGS and VICAL, HGS and
VICAL shall share equally in the cost and expense thereof. Unless the
parties otherwise agree, HGS shall be the lead party on HGS
IMPROVEMENTS and VICAL shall be the lead party on VICAL IMPROVEMENTS.
The lead party shall consult with the other with respect to strategies
for filing, prosecution and maintenance of patents and patent
applications for which it bears responsibility under this paragraph,
and shall keep the other reasonably informed with regard to filing,
prosecution and maintenance activity for such patents and patent
applications. In the event the lead party does not intend to prepare,
file, prosecute and/or maintain patent protection in any country with
respect to such joint invention, the lead party shall notify the other
party and the other party may
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assume such responsibility at its own cost and expense. Any patent on
such joint invention shall be considered both an HGS PATENT and a VICAL
PATENT.
10.4 Both parties will provide the other reasonable assistance to enable the
other to prepare, file, prosecute and maintain patents pursuant to this
Article 10.
10.5 In the event of the institution of any suit by a THIRD PARTY,
(a) against VICAL, its AFFILIATES, or its licensees (other than
HGS) for patent infringement involving the manufacture, use,
import, export, offer for sale, sale, distribution or
marketing of EXCLUSIVE VICAL PRODUCT, VICAL shall promptly
notify HGS in writing. As between HGS and VICAL, VICAL shall
be solely responsible for the cost and expense of such action
and any liability, which results therefrom;
(b) against HGS, its AFFILIATES, or its licensees (other than
VICAL) for patent infringement involving the manufacture, use,
import, export, offer for sale, sale, distribution or
marketing of EXCLUSIVE HGS PRODUCT, HGS shall promptly notify
VICAL in writing. As between HGS and VICAL, HGS shall be
solely responsible for the cost and expense of such action and
any liability, which results therefrom;
(c) The party defending an action under this Paragraph 10.5 shall
have full control over its conduct, including settlement
thereof provided such settlement shall not be made without the
prior written consent of the other party if it would adversely
affect the patent rights of such party licensed hereunder.
10.6 In the event that HGS or VICAL becomes aware of actual or threatened
infringement of a VICAL PATENT or HGS PATENT that claims an EXCLUSIVE
VICAL PRODUCT or EXCLUSIVE HGS PRODUCT or the use thereof, that party
shall promptly notify the other party in writing. The owner of the
VICAL PATENT or HGS PATENT shall have the first right but not the
obligation to bring, at its own expense, an infringement action against
any THIRD PARTY and to use the other party's name in connection
therewith. If the owner of the patent does not commence a particular
infringement action within ninety (90) days, the other party, after
notifying the owner in writing, shall be entitled to bring such
infringement action, in its own name and/or in the name of the patent
owner, at its own expense to the extent that such party is licensed
thereunder. The foregoing notwithstanding, in the event that an alleged
infringer certifies pursuant to 21 U.S.C. Section 355(b)(2)(A)(iv)
against an issued VICAL PATENT or HGS PATENT that claims EXCLUSIVE
VICAL PRODUCT or EXCLUSIVE HGS PRODUCT or the use thereof,
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as between the patent owner and the owner of the product, the party
receiving notice of such certification shall immediately notify the
other party of such certification, and if fourteen (14) days prior
to expiration of the forty five (45) day period set forth in 21
U.S.C. Section 355(c)(3)(C), the owner of the patent fails to
commence an infringement action, the party receiving notice, in its
sole discretion, at its own expense and to the extent that it is
licensed under the patent, shall be entitled to bring such
infringement action in its own name and/or in the name of the patent
owner. The party conducting an action under this Paragraph 10.6
shall have full control over its conduct, including settlement
thereof provided such settlement shall not be made without the prior
written consent of the other party if it would adversely affect the
patent rights of such party licensed hereunder. The licensing party
(i.e., the patent owner) and the licensed party (i.e., the owner of
the product) shall reasonably assist one another and cooperate in
any such litigation at the other's request, each such party paying
its own costs and expenses. The party conducting the litigation
shall periodically reimburse the other party for its reasonable and
actual out-of-pocket expenses incurred at the request of the party
conducting the litigation for assisting in the litigation, which
reimbursement shall be made within thirty (30) days of receipt by
the party conducting the litigation of itemized invoices from the
assisting party documenting such expenses.
10.7 Any recovery made by a party as the result of an action for patent
infringement it has conducted under Paragraph 10.6 shall be distributed
as follows:
(a) The party conducting the action shall recover its actual out
-of-pocket expenses, and then shall reimburse the other party
for any unreimbursed actual and out-of-pocket expenses.
(b) To the extent that the recovery exceeds the total of item (a),
the excess shall be kept by the party conducting the action,
provided, however, that to the extent that (i) the recovery is
based on an award of lost sales/profits, and (ii) the party
conducting the action would have incurred a royalty obligation
to the other party based upon such sales, the party to whom
such royalties would have been due shall receive a proportion
of the excess recovery corresponding to the royalty percentage
it would have otherwise been due.
10.8 The parties shall periodically keep one another reasonably informed of
the status of their respective activities regarding any such litigation
or settlement thereof.
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11 STATEMENTS AND REMITTANCES
11.1 VICAL and HGS, as the case may be, shall keep and require its
AFFILIATES and licensees to keep complete and accurate records of all
sales and calculations for NET SALES of PRODUCTS. Each party shall have
the right, at its expense, through an independent certified public
accounting firm of nationally recognized standing reasonably acceptable
to the other party, to examine pertinent financial records during
regular business hours upon proper advance written notice during the
life of this Agreement and for *** after its termination for the
purpose of verifying and reporting to HGS or VICAL as to the
computation of the royalty payments made hereunder during the preceding
*** prior to the date of such examination; provided, however, that such
examination shall not take place more often than once a year; provided
further that such accountant shall report only as to the accuracy of
the royalty statements and payments, including the magnitude and source
of any discrepancy. VICAL, HGS, and their respective AFFILIATES and
licensees shall be required to maintain such sales and royalty
calculation records for ***. The accountant shall execute customary
confidentiality agreements prior to any examination, reasonably
satisfactory in form and substance to both parties, to maintain in
confidence all information obtained during the course of any such
examination, except for disclosure to the parties, as necessary for the
above purpose.
11.2 Within sixty (60) days after the close of each calendar quarter, VICAL
and HGS, as the case may be, shall deliver to the other party a true
accounting of all amounts owing hereunder sold by it and its licensees
and distributors during such calendar quarter and shall at the same
time pay all amounts due.
11.3 All royalties and other payments due under this Agreement shall be
payable in U.S. dollars.
11.4 Royalties payable on sales in countries other than the United States
shall be calculated by
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*** Confidential material redacted and separately filed with the Commission.
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multiplying the appropriate royalty rate times the sales in each
currency in which they are made and converting the resulting amount
into United States dollars, at the rates of exchange as reported in The
Wall Street Journal as published under the caption
"Currency Trading", on the last business day in New York, New York of
each royalty period. If the Wall Street Journal ceases to be published,
then the rate of exchange to be used shall be that reported in such
other business publication as all parties reasonably agree. Such
payments shall be without deduction of exchange, collection, or other
charges. If, due to restrictions or prohibitions imposed by a national
or international authority, payments cannot be made as aforesaid, the
parties shall consult with a view to finding a prompt and acceptable
solution, and the parties will deal with such monies as the other party
may lawfully direct at no additional out-of-pocket expense to the party
owed the royalty. Notwithstanding the foregoing, if royalties cannot be
remitted for any reason within six (6) months after the end of the
calendar quarter during which they are earned, then the party owing the
royalty shall be obligated to deposit the royalties in a bank account
in the country of sale in the name of the other party. Each party shall
deduct any taxes which the party is obligated to pay and/or withhold in
a country based on royalties due to the other based on sales in such
country from royalty payments due for such country under this Agreement
and pay them to the proper authorities as required by applicable laws.
Each party shall maintain official receipts of payment of any such
taxes and forward these receipts to the other within sixty (60) days.
11.5 All payments to be made hereunder shall be by wire transfer of
immediately available funds to an account designated by HGS or VICAL,
whoever is to be the recipient of such funds.
12 TERM AND TERMINATION
12.1 This Agreement shall come into effect as of the Effective Date, and
unless earlier terminated as provided in this Article 12, shall remain
in full force and effect on a PRODUCT by PRODUCT and country-by-country
basis, until the last to expire of the applicable party's royalty
obligations under this Agreement with respect to such PRODUCT in such
country.
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12.2 A party shall have the right to terminate this Agreement with respect
to any PRODUCT upon the material breach by the other party of the other
party's obligations with respect to such PRODUCT under Article 8 if
such breach is not cured within sixty (60) days after receipt of
written notice from such party thereof. Notwithstanding the foregoing,
a party may not terminate this Agreement during the pendency of an
arbitration proceeding under this Agreement in which the other party
reasonably contests whether it has failed to meet its obligations under
Article 8.
12.3 A party shall have the right to terminate this Agreement in its
entirety (a) upon the material breach by the other party of the other
party's obligations to pay any amounts owing hereunder, if such breach
is not cured within thirty (30) days after receipt of written notice
from such party thereof, or (b) upon the material breach by the other
party of the other party's obligations (other than obligations under
Article 8 or obligations to pay any amounts owing hereunder), if such
breach is not cured within sixty (60) days after receipt of written
notice from such party thereof. Notwithstanding the foregoing, a party
may not terminate this Agreement during the pendency of an arbitration
proceeding under this Agreement in which the other party reasonably
contests whether a royalty or other amount is due hereunder, or whether
it has failed to satisfy its other obligations hereunder.
12.4 Either party, may terminate this Agreement if, at any time, the other
party shall file in any court or agency pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of the party or of its assets, or
if the other party proposes a written agreement of composition or
extension of its debts, or if the other party shall be served with an
involuntary petition against it, filed in any insolvency proceeding,
and such petition shall not be dismissed within sixty (60) days after
the filing thereof, or if the other party shall propose or be a party
to any dissolution or liquidation, or if the other party shall make an
assignment for the benefit of creditors.
12.5 Neither party shall have the right to terminate this Agreement except
under Paragraphs 12.2, 12.3 and 12.4, provided however that nothing in
this Agreement shall limit any remedies for breach which may be
available pursuant to a judgment of a court, in law or
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equity, including termination of this Agreement or of any or all rights
hereunder, except that any action seeking remedies for breach of this
Agreement shall be conducted in accordance with Article 16.
12.6 Notwithstanding termination of this Agreement, the rights and
obligations of the parties under Articles 9, 10, 12, 13, 14 and 16 and
Paragraphs 3.12, 3.13, 3.14 and 3.15 shall survive such termination, as
well as any provision not specified in this paragraph which is clearly
meant to survive termination of this Agreement. Upon expiration of this
Agreement under Paragraph 12.1 with respect to a particular PRODUCT in
a particular country, the licenses granted under Paragraphs 3.3 and 3.6
under VICAL TECHNOLOGY and HGS TECHNOLOGY shall survive on a
non-exclusive basis.
12.7 Termination of the Agreement in accordance with the provisions hereof
shall not limit remedies that may be otherwise available in law or
equity.
13 WARRANTIES AND REPRESENTATIONS
13.1 Each of HGS and VICAL hereby represents, warrants and covenants to the
other, as of the date of this Agreement, as follows:
(a) it is a corporation duly organized and validity existing under
the laws of the state of its incorporation;
(b) the execution, delivery and performance of this Agreement by
such party has been duly authorized by all requisite corporate
action;
(c) it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder, including,
without limitation, the right, power and authority to grant
the licenses under Article 3;
(d) the execution, delivery and performance by such party of this
Agreement and its compliance with the terms and provisions
hereof to such party's best knowledge does not conflict with
or result in a breach of any of the terms and provisions of or
constitute a default under (i) a loan agreement, guaranty,
financing agreement,
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agreement affecting a product or other agreement or instrument
binding or affecting it or its property; (ii) the provisions
of its charter documents or bylaws; or (iii) any order, writ,
injunction or decree of any court or governmental authority
entered against it or by which any of its property is bound;
and
(e) this Agreement constitutes such party's legal, valid and
binding obligation enforceable against it in accordance with
its terms subject, as to enforcement, to bankruptcy,
insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and
to the availability of particular remedies under general
equity principles.
13.2 No party to this Agreement has in effect, and, after the date of this
Agreement, no party shall enter into any written agreement that would
be inconsistent with its obligations under this Agreement.
13.3 NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A WARRANTY THAT VICAL
PATENTS OR HGS PATENTS ARE VALID OR ENFORCEABLE OR THAT THEIR EXERCISE
OR THE EXERCISE OF HGS TECHNOLOGY OR VICAL TECHNOLOGY DOES NOT INFRINGE
ANY PATENT RIGHTS OF THIRD PARTIES. A HOLDING OF INVALIDITY OR
UNENFORCEABILITY OF ANY SUCH PATENT, FROM WHICH NO FURTHER APPEAL IS OR
CAN BE TAKEN, SHALL NOT AFFECT ANY OBLIGATION HEREUNDER, BUT SHALL ONLY
ELIMINATE ROYALTIES OTHERWISE DUE UNDER SUCH PATENT FROM THE DATE SUCH
HOLDING BECOMES FINAL.
13.4 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN HGS AND VICAL MAKE NO
REPRESENTATIONS OR EXTEND ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT.
13.5 Each party shall use any materials provided by the other party under
this Agreement in compliance with all applicable laws and regulations.
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14 INDEMNIFICATION
14.1 VICAL shall defend, indemnify and hold harmless HGS, its AFFILIATES,
licensors of HGS and each of their respective directors, officers,
shareholders, agents and employees, from and against any and all
liability, loss, damages and expenses (including reasonable attorneys'
fees) as the result of claims, demands, actions or proceedings by any
THIRD PARTY which are made or instituted against any of them arising
out of the development, manufacture, possession, distribution, use,
testing, sale or other disposition of any EXCLUSIVE VICAL PRODUCT by or
through VICAL, its AFFILIATES or any THIRD PARTY granted rights by
VICAL under this Agreement. VICAL's obligation to defend, indemnify and
hold harmless shall include claims, demands, actions or proceedings,
whether for money damages or equitable relief by reason of alleged
personal injury (including death) to any person or alleged property
damage, provided, however, the indemnity shall not extend to any claims
against an indemnified party which result from the gross negligence or
willful misconduct of an indemnified party. VICAL shall have the
exclusive right to control the defense of any action which is to be
indemnified in whole by VICAL hereunder, including the right to select
counsel reasonably acceptable to HGS to defend HGS and the indemnified
parties hereunder, and to settle any claim, demand, action or
proceeding, provided that, without the prior written consent of HGS
(which shall not be unreasonably withheld or delayed), VICAL shall not
agree to settle any claim, demand, action or proceeding against HGS to
the extent such claim has a material adverse effect on HGS. The
provisions of this Paragraph 14.1 shall survive and remain in full
force and effect after any termination, expiration or cancellation of
this Agreement and the obligation hereunder shall apply whether or not
such claims are rightfully brought. VICAL shall require each licensee
to agree to indemnify HGS in a manner consistent with this Paragraph
14.1.
14.2 HGS shall defend, indemnify and hold harmless VICAL, its AFFILIATES,
licensors of VICAL and each of their respective directors, officers,
shareholders, agents and employees, from and against any and all
liability, loss, damages and expenses (including reasonable attorneys'
fees) as the result of claims, demands, actions or proceedings by a
THIRD PARTY which are made or instituted against any of them arising
out of the
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development, manufacture, possession, distribution, use, testing,
sale or other disposition of EXCLUSIVE HGS PRODUCT by or through
HGS, its AFFILIATES or any THIRD PARTY granted rights by HGS
under this Agreement. HGS' obligation to defend, indemnify and hold
harmless shall include claims, demands, actions or proceedings, whether
for money damages or equitable relief by reason of alleged personal
injury (including death) to any person or alleged property damage,
provided, however, the indemnity shall not extend to any claims against
an indemnified party which result from the gross negligence or willful
misconduct of an indemnified party. HGS shall have the exclusive right
to control the defense of any action which is to be indemnified in
whole by HGS hereunder, including the right to select counsel
reasonably acceptable to VICAL to defend VICAL and the indemnified
parties hereunder, and to settle any claim, demand, action or
proceeding, provided that, without the prior written consent of VICAL
(which shall not be unreasonably withheld or delayed), HGS shall not
agree to settle any claim, demand, action or proceeding against VICAL
to the extent such claim has a material adverse effect on VICAL. The
provisions of this Paragraph 14.2 shall survive and remain in full
force and effect after any termination, expiration or cancellation of
this Agreement and the obligation hereunder shall apply whether or not
such claims are rightfully brought. HGS shall require each licensee to
agree to indemnify VICAL in a manner consistent with this Paragraph
14.2.
14.3 A person or entity that intends to claim indemnification under this
Article 14 (the "Indemnitee") shall promptly notify the other party
(the "Indemnitor") of any claim, demand, action or proceeding for which
the Indemnitee intends to claim such indemnification, and the
Indemnitor, after it determines that indemnification is required of it,
shall assume the defense thereof with counsel selected by the
Indemnitor and reasonably acceptable to the other party, 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
Indemnitor does not assume the defense; or, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be
inappropriate due to actual or potential conflicts of interest between
such Indemnitee and any other party represented by such counsel in such
proceedings. The indemnity agreement in this Article 14 shall not apply
to amounts paid in settlement of any claim, demand, action or
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proceeding if such settlement is effected without the consent of the
Indemnitor, which consent shall not be unreasonably withheld or
delayed. 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 14,
but failure 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 14. The Indemnitee under this Article 14, its employees
and agents, shall cooperate reasonably with the Indemnitor and its
legal representatives in the investigations of any claim, demand,
action or proceeding covered by this indemnification. In the event that
each party claims indemnity from the other and one party is finally
held liable to indemnify the other, 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.
15 FORCE MAJEURE
15.1 If the performance by a party of any obligation under this Agreement
(other than an obligation for a payment of money), is prevented,
restricted, interfered with or delayed by reason of any reasonable,
unforeseeable cause beyond the reasonable control of the party liable
to perform, the party so affected shall, upon giving written notice to
the other party, be excused from such performance to the extent of such
prevention, restriction, interference or delay, provided that the
affected party shall use its commercially reasonable efforts to avoid
or remove such causes of non-performance and shall continue performance
with the utmost dispatch whenever such causes are removed. When such
circumstances arise, the parties shall discuss what, if any,
modification of the terms of this Agreement may be required in order to
arrive at an equitable solution.
16 DISPUTE RESOLUTION
16.1 This Agreement shall be construed and enforced in accordance with the
laws of the State of Delaware (without reference to the conflicts of
law principles thereof).
16.2 In the event of any controversy, dispute or claim arising out of or
relating to any provision of this Agreement or the breach thereof, the
parties shall use good faith efforts
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to settle such controversy, dispute, or claim amicably between
themselves.
16.3 Should the parties fail to reach mutually acceptable settlement of any
controversy, dispute or claim which may arise out of or in connection
with this Agreement, or the breach, termination or validity thereof
(other than with respect to patent validity) shall be settled by final
and binding arbitration pursuant to the Commercial Arbitration Rules of
the American Arbitration Association ("AAA") as herein provided.
(a) The Arbitration Tribunal shall consist of three arbitrators.
Each party shall nominate in the request for arbitration and
the answer thereto one arbitrator and the two arbitrators so
named will then jointly appoint the third arbitrator as
chairman of the Arbitration Tribunal. If one party fails to
nominate its arbitrator or, if the parties' arbitrators cannot
agree on the person to be named as chairman within sixty (60)
days, the necessary appointments shall be made under the rules
of the AAA.
(b) The place of arbitration shall be in Chicago, Illinois and the
arbitration proceedings shall be held in English. The
procedural law of the State of Illinois shall apply where the
AAA Rules are silent.
The award of the Arbitration Tribunal shall be final and judgment upon such an
award may be entered in any competent court or application may be made to any
competent court for judicial acceptance of such an award and order of
enforcement. Notwithstanding the foregoing, nothing contained herein shall
prevent either party from seeking interim relief from a court of competent
jurisdiction pending the establishment of or a decision by a panel of
arbitrators.
17 SEPARABILITY
17.1 In the event any portion of this Agreement shall be held illegal, void
or ineffective, the remaining portions hereof shall remain in full
force and effect.
17.2 If any of the terms or provisions of this Agreement are in conflict
with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may
conflict therewith and shall be deemed to be modified to conform with
such statute or rule of law.
17.3 In the event that the terms and conditions of this Agreement are
materially altered as a result of Paragraphs 17.1 or 17.2, the parties
will, in good faith, renegotiate the terms and conditions of this
Agreement to resolve any inequities.
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18 ENTIRE AGREEMENT
18.1 This Agreement, together with the Appendices hereto, entered into as of
the date written above constitutes the entire agreement between the
parties relating to the subject matter hereof and supersedes all
previous writings and understandings. No terms or provisions of this
Agreement shall be varied or modified by any prior or subsequent
statement, conduct or act of either of the parties, except that the
parties may amend this Agreement by written instruments specifically
referring to and executed in the same manner as this Agreement.
19 NOTICES
19.1 Any notice required or permitted under this Agreement shall be
hand-delivered or sent by express delivery service or certified or
registered mail, postage prepaid, or by fax with written confirmation
by mail, to the following addresses of the parties:
HUMAN GENOME SCIENCES, INC.
0000 Xxx Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: Senior Vice President, Corporate Development
Fax: 000-000-0000
copy to:
HUMAN GENOME SCIENCES, INC.
0000 Xxx Xxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: General Counsel
Fax: 000-000-0000
VICAL INCORPORATED
0000 Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: President
Fax: 000-000-0000
copy to:
PILLSBURY MADISON & SUTRO
00 Xxxxxxx Xxxxxx
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxx X. Xxxxxx, Xx.
Fax: 000-000-0000
19.2 Any notice required or permitted to be given concerning this Agreement
shall be
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effective upon receipt by the party to whom it is addressed.
20 ASSIGNMENT AND CHANGE OF CONTROL
20.1 This Agreement and the licenses herein granted shall be binding upon
and inure to the benefit of the parties and their respective permitted
assignees and successors in interest of the respective parties. Neither
this Agreement nor any interest hereunder shall be assignable by a
party without the prior written consent of the other party and any
attempted assignment contrary to this Paragraph 20.1 shall be void and
without force and effect. Notwithstanding the foregoing, a party may
assign this Agreement and all its rights and obligations hereunder to
any AFFILIATE or to any THIRD PARTY in connection with the transfer or
sale of all or substantially all of its business, or all or
substantially all of its assets to which this Agreement relates, or in
the event of its merger, consolidation, change in control or similar
transaction, without obtaining the consent of the other party, provided
that the THIRD PARTY assignee or surviving entity assumes in writing
all of its obligations under this Agreement.
20.2 ***
21 COUNTERPARTS
21.1 This Agreement may be executed in any number of counterparts, and each
such counterpart shall be deemed an original instrument, but all such
counterparts together shall constitute but one agreement.
22 WAIVER
22.1 Any delay or failure in enforcing a party's rights under this Agreement
or any waiver as to a particular default or other matter shall not
constitute a waiver of such party's rights to the future enforcement of
its rights under this Agreement, nor operate to bar the exercise or
enforcement thereof at any time or times thereafter, excepting only as
to an express
____________
*** Confidential material redacted and separately filed with the Commission.
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written and signed waiver as to a particular matter for a particular
period of time.
22.2 Notwithstanding the foregoing, in the event VICAL or HGS challenges
whether any payments contemplated hereunder (including, without
limitation royalties or milestones) are due, it shall have the right,
but not the obligation, to make such payments under protest (reserving
all rights hereunder) pending resolution of such dispute.
23 INDEPENDENT RELATIONSHIP
23.1 Nothing herein contained shall be deemed to create an employment,
agency, joint venture or partnership relationship between the parties
hereto or any of their agents or employees, or any other legal
arrangement that would impose liability upon one party for the act or
failure to act of the other party. No party shall have any power to
enter into any contracts or commitments or to incur any liabilities in
the name of, or on behalf of, the other party, or to bind the other
party in any respect whatsoever.
24 FURTHER ACTIONS
24.1 Each party agrees to execute, acknowledge and deliver such further
instruments and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this
Agreement.
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IN WITNESS WHEREOF, the parties, through their authorized officers, have
executed this Agreement as of the Effective Date.
VICAL INCORPORATED
BY: /s/ Xxxxx X. Xxxxxxxxx
------------------------------
Xxxxx X. Xxxxxxxxx, M.D.
Title: President and Chief Executive Officer
HUMAN GENOME SCIENCES, INC.
BY: /s/ Xxxxxx X. Xxxxxxx
------------------------------
Xxxxxx X. Xxxxxxx
Title: Sup. Corporate Development
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APPENDIX A
***
____________
*** Confidential material redacted and separately filed with the Commission.
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XXXXXXXX X
***
____________
*** Confidential material redacted and separately filed with the Commission.
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