*Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
200.83 and 240.24b-2
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
This COLLABORATIVE RESEARCH AND LICENSE AGREEMENT (the "Agreement") is
made as of July 9, 2001 (the "Effective Date"), by and between ISIS
PHARMACEUTICALS, INC., a Delaware corporation ("Isis"), having a principal place
of business at Carlsbad Research Center, 0000 Xxxxxxx Xxxxxx, Xxxxxxxx,
Xxxxxxxxxx 00000 and PE CORPORATION (NY), a New York corporation, through the
CELERA GENOMICS GROUP, ("Celera"), having a principal place of business at 00
Xxxx Xxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000. Celera and Isis may be referred to
herein individually as a "Party" and collectively as the "Parties".
RECITALS
WHEREAS, Isis possesses proprietary technology and know-how related to
anti-sense technologies; and
WHEREAS, Celera possesses proprietary technology and know-how related
to genomics; and
WHEREAS, Celera and Isis desire collaborate to generate information on
gene function for up to [*] novel targets.
NOW, THEREFORE, in consideration of the various promises and
undertakings set forth herein and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties agree as
follows:
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" with respect to either Party, will mean any Person
controlling, controlled by, or under common control with such Party. For the
purposes of this Section 1.1 only, "control" will refer to (a) the possession,
directly or indirectly, of the power to direct the management or policies of a
Person, whether through the ownership of voting securities, by contract or
otherwise, together with (b) the ownership, directly or indirectly, of at least
fifty percent (50%) of the voting securities or other ownership interest of a
Person. Notwithstanding the foregoing, [*]
1.2 "Agreement NPV" means the net present value of any agreement
calculated pursuant to Section Article 6.3(d) or as determined by the JEC by
unanimous recorded vote.
1.3 "Antisense Inhibitor" means an Oligonucleotide that is designed
to inhibit protein synthesis at the nucleic acid level by specifically binding
to the sequence of a selected messenger or viral ribonucleic acid by
base-paring.
* Confidential Treatment Requested
1.4 "Celera Exclusive Collaboration Patents" means all Patent Rights
comprising method of use, method of prevention, treatment or diagnosis of a
disease or condition or other identification of gene function associated with a
Celera Exclusive Target arising out of the collaboration and for which
Collaboration Data is used in the prosecution, maintenance or defense of such
Patent Rights. Celera Exclusive Collaboration Patents specifically includes
Collaboration Patents to the extent they otherwise come under the definition of
Celera Exclusive Collaboration Patents.
1.5 "Celera Exclusive Targets" means the Celera Gene Targets
selected by Celera pursuant to Section 3.2 (c), or any fragment or allelic
variant of such Celera Gene Target or degenerative sequence of the foregoing
encoding the identical amino acid sequence.
1.6 "Celera Gene Availability Pool" means the Celera Gene Targets
available for Celera to designate for exclusive use pursuant to Section
3.2(c). Once the Option Period has expired for a specific Celera Gene Target
it will cease to be part of the Celera Gene Availability Pool.
1.7 "Celera Gene Target" means a Gene selected for High Throughput
Gene Functionalization.
1.8 "Celera Licensed Patents" means (i) all Patent Rights that
are Controlled by Celera prior to the selection of Celera Gene Target
pursuant to Section 3.1 that claim inventions consisting of any Celera Gene
Target or any fragment of such Celera Gene Target, and/or any nucleic acid
sequence, protein, peptide or other composition of matter encoded thereby,
including, without limitation, inventions claiming method of use or treatment
of a disease or condition by inhibiting such gene or other identification of
gene function, and (ii) all Patent Rights whether or not Controlled by Celera
not arising out of the collaboration where Collaboration Data is used in the
prosecution, maintenance or defense of such Patent Rights. Celera Licensed
Patents will specifically exclude Collaboration Patents, Celera Exclusive
Collaboration Patents, Joint Patents and any Patent Rights that are
Controlled by Celera claiming solely diagnosis of a disease or condition.
1.9 "Celera Product" means any Gene Therapy Product, Protein
Therapeutic Product, Small Molecule Therapeutic Product or Vaccine Product
discovered by Celera alone or as part of a bona fide drug discovery
collaboration that, but for the licenses granted herein, would infringe a
Celera Exclusive Collaboration Patent.
1.10 "Collaboration Data" means any and all data created using an
Antisense Inhibitor pursuant to the Research Plan, including without
limitation, in Isis's HGTF system.
1.11 "Collaboration Patents" means all Patent Rights comprising
method of use, method of prevention, treatment or diagnosis of a disease or
condition or other identification of gene function associated with a Celera
Gene Target arising out of the collaboration and for which Collaboration Data
is included in or used in the prosecution,
2
maintenance or defense of such Patent Rights. Collaboration Patents specifically
excludes Oligonucleotide Patents. Collaboration Patents specifically includes
jointly invented Patent Rights to the extent that they otherwise come under the
definition of Collaboration Patents, and any such jointly invented Patent Rights
will not be Joint Patents.
1.12 "Common Product" means (i) any and all Licensed Products that
are neither Isis Products nor Celera Products for a Celera Exclusive Target,
and (ii) any and all License Products that are not Isis Products for a Celera
Gene Target that is not a Celera Exclusive Target.
1.13 "Confidential Information" means a Party's confidential
information, inventions, know-how, data and materials relating to the
Research, or the Celera Gene Targets, Celera Exclusive Targets, Lead Oligos or
Licensed Products, including without limitation research, technical, clinical
development, manufacturing, marketing, financial personnel and other business
information and plans, which, if disclosed in written, graphic or electronic
form, is marked or otherwise designated as "confidential" or "proprietary"
and, if disclosed orally, is summarized and designated as "confidential" or
"proprietary" in a writing provided to the receiving Party not later than
sixty (60) days after such disclosure. All information presented at the JRC,
Intellectual Property Committee or JEC meetings will be rebuttably presumed to
be Confidential Information, regardless of whether it would otherwise qualify
as such pursuant to the preceding sentence.
1.14 "Control" means, with respect to an item of Information or an
intellectual property right, possession of the ability, whether by ownership
or license, to grant a license or sublicense as provided for herein under such
item or right without violating the terms of any agreement or other
arrangements with any Third Party.
1.15 "Effective Date" means the effective date of this Agreement as
set forth in the first paragraph above.
1.16 "Extended Term" has the meaning set forth in Section 5.1(e).
1.17 "Gene" means a DNA or RNA sequences of human or other origin
that encodes a protein or other molecule.
1.18 "Gene Therapy Product" means any nucleic acid molecule, other
than an Antisense Inhibitor or Oligonucleotide, that is introduced into human
cells for the treatment or prevention of any disease, condition or risk based
on modifying the expression of the target gene or modifying the genetic code
of the target gene.
1.19 "High Throughput Gene Functionalization" or "HTGF" means Isis's
High Throughput Screening system and standard phenotypic assays as it may
exist from time-to-time and as more fully described in the Research Plan.
1.20 "Information" means any data, results, information, know-how,
techniques, methods, development, material, or compositions of matter of any
type or kind.
3
1.21 "Intellectual Property Committee" has the meaning set forth in
Section 6.2.
1.22 "Isis Product" means any Oligonucleotide used in the treatment
or prevention of a disease or condition that, but for the licenses granted
herein, would infringe a Collaboration Patent.
1.23 "Joint Executive Committee" or "JEC" means that committee to be
formed pursuant to Section 6.3.
1.24 "Joint Patents" means all Patent Rights that claim inventions
that are made by employees or agents of Celera and Isis jointly and name as
inventors one or more employees of Celera and Isis together with one or more
employees or agents of the other Party. Joint Patents will not include any
Collaboration Patents or Oligonucleotide Patents.
1.25 "Joint Research Committee" or "JRC" means that committee to be
formed pursuant to Section 6.1.
1.26 "Lead Oligo" means an Antisense Inhibitor to a Celera Gene
Target which decreases expression of such Celera Gene Target by at least [ *].
1.27 "Lead Oligo Reagent" means a Lead Oligo derived using the
2'-methoxyethyl gapmer with fully phosphorothioate backbone chemistry of the
HTGF system or an alternative for certain limited applications.
1.28 "Licensed Product" means any composition, material, device,
kit, process or other product or process, the manufacture, use or sale of
which would infringe a Collaboration Patent.
1.29 "Licensing Revenue" means revenue derived from the licensing of
Collaboration Patents to Third Parties including without limitation, license
fees, maintenance fees, milestones, and royalties but excluding payments for
research and development. If either Party licenses Collaboration Patents to
Third Parties together with other material intellectual property, the
consideration received for such license, will be allocated by such Party in
good faith among the components of the license. If payments are made in
non-cash consideration, such Party will, at its option, either provide the
other Party consideration in kind or in cash (based on a reasonable
determination of value).
1.30 "Minimum Permitted Value" means a net present value of an
agreement equal to [*].
1.31 "Oligonucleotide" means any compound containing between [* ]
nucleotides and/or nucleosides, including oligonucleotide analogs which may
include natural or modified heterocycles, sugars and or backbone linkages.
1.32 "Oligonucleotide Patent" means all Patent Rights arising out of
the collaboration that claims Antisense Inhibitors or Oligonucleotides and/or
their method of use including without limitation the prevention or treatment
of a disease or condition.
*Confidential Treatment Requested 4
Oligonucleotide Patents will include any jointly invented Patent Rights that
otherwise meets this definition.
1.33 "Option" has the meaning set forth in Section 3.2(c).
1.34 "Option Period" has the meaning set forth in Section 3.2(c).
1.35 "Patent Right" means (i) an issued and existing patent,
including any extensions, supplemental protection certificates, registrations,
confirmations, reissues, reexaminations or renewals thereof, (ii) pending
applications, including any continuation, divisional, or continuation-in-part
application thereof, for any of the foregoing, and (iii) all counterparts to
any of the foregoing issued by or filed in any country or other jurisdiction.
1.36 "Person" means any natural person, corporation, firm, business
trust, business unit, joint venture, association, organization, company,
limited liability company, partnership or other business entity, or any
government or agency or political subdivision thereof.
1.37 "Protein Therapeutic Product" means a protein, peptide or
peptidomimetic analogous to a peptide or any derivative of the foregoing that
is used for the treatment or prevention of any disease, condition or risk
thereof.
1.38 "Research" means the collaborative research program undertaken
by the Parties pursuant to the Research Plan during the Research Term.
1.39 "Research Plan" means the specific plan for HTGF screening of
Celera Gene Targets, as described in Section 2.1, which will be attached
hereto as Exhibit A.
1.40 "Research Term" means the period commencing on the Effective
Date and terminating eighteen (18) months thereafter (or such earlier date as
of which this Agreement is terminated hereunder).
1.41 "Small Molecule Therapeutic Product" means a small organic or
inorganic molecule (less than 800 daltons) used for the treatment or
prevention of any disease, condition or risk thereof, excluding any such
molecule whose primary mode of activity is binding to RNA.
1.42 "Sublicensee" means a Person other than an Affiliate of Isis or
Celera to which Isis or Celera has granted sublicense rights under the
licenses granted hereunder, which rights include at least the rights to make
and sell Licensed Products.
1.43 "Third Party" means any Person other than Celera, Isis or
Affiliates of either of them, or any Sublicensee.
1.44 "Vaccine Product" means a protein, peptide or a nucleic acid
molecule other than an Oligonucleotide, that stimulates an active specific
immune response for the treatment or prevention of a disease or condition.
5
1.45 "Valid Claim" means a claim of an issued and unexpired patent
which has not been revoked or held unenforceable or invalid by a decision of a
court or governmental agency of competent jurisdiction from which no appeal
can be taken or, after mutual consultation and agreement, an appeal is not
taken within the time allowed for appeal, and which has not been disclaimed,
denied or admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise.
ARTICLE 2
RESEARCH
2.1 Subject to the terms and conditions herein, the Parties will
each use commercially reasonable diligent efforts to conduct the Research on
a collaborative basis. Subject to Section 2.2(d) and other applicable
provisions, the Parties will conduct the Research as specified in the
Research Plan. The Research Plan attached hereto as Exhibit A describes the
HTGF screening process that will be used to create Antisense Inhibitors to
Celera Gene Targets and screen such Antisense Inhibitors in Isis' phenotypic
assays to provide information useful in gene functionalization and target
validation.
2.2 Conduct of the Research.
(a) The Research will be managed and directed by the JRC, as
provided in 6.1.
(b) During the course of the Research, each Party will
disclose to the other such Information as the other Party reasonably needs to
conduct its obligations and assigned tasks under the Research Plan.
(c) In order to protect the Parties' patent rights in
any inventions conceived or reduced to practice during or as a result of the
Research, each Party agrees to implement a policy which requires its employees
to record and maintain all data and information developed during the Research in
such a manner as to enable the Parties to use such records to establish the
earliest date of invention and/or diligence to reduction to practice.
(d) The Parties agree to commit the quality and quantity
of resources required to perform their obligations under the Research Plan.
2.3 Liability. In connection with the conduct of the Research, each
Party will be responsible for, and hereby assumes, any and all risks of
personal injury or property damage attributable to the negligent acts or
omissions of that Party and its directors, officers, employees and agents.
ARTICLE 3
SELECTION OF CELERA GENE TARGETS AND CELERA EXCLUSIVE
TARGETS
6
3.1 Selection of Celera Gene Targets.
(a) Celera will select Genes for functionalization studies
under the Research Plan ("Celera Gene Targets") and notify Isis of the identity
of such Celera Gene Target in writing.
(b) Genes selected by Celera under Section 3.1(a) will be
included in the HTGF queue unless prior to such selection: (i) such Genes were
prioritized by Isis for the HTGF queue; (ii) Isis had generated Antisense
Inhibitors to such Gene; or (iii) Isis has bona fide pre-existing agreement to
work on such Gene with a Third Party (Subsections (i), (ii) and (iii),
"Rejected Genes"); and provided that Isis notifies Celera of the identity of
any Rejected Gene in writing within ten (10) business days of Celera's
selection of such Gene. Celera may select a replacement Gene for any Rejected
Gene and such Rejected Gene will be treated as if it had never been selected by
Celera. The identity of any Celera Gene Target or Rejected Gene will be the
Confidential Information of Celera.
(c) Isis agrees to conduct the Research under the Research Plan
and will provide reports to the JRC on a quarterly basis. These reports will
contain all information necessary to keep the JRC fully informed regarding the
performance of the Research Plan. Notwithstanding the preceding sentence, the
Parties acknowledge that there is no guarantee that a Lead Oligo will be
discovered using the HTS process.
(d) Celera knows and understands that it will be the primary
source of Celera Gene Targets under the Research Plan and that Isis will not
conduct any patent due diligence regarding its freedom to synthesize or screen
Antisense Inhibitors to such targets or to provide Antisense Inhibitors to
Celera hereunder. Subject to Sections 10.1 and 10.3, Celera will indemnify and
hold Isis harmless from any liability to Third Parties by reason of the use by
Isis of Celera Gene Targets solely for Isis' work under the Research Plan
during the Research Term. For clarification, Celera will not indemnify Isis,
and Celera will not be liable to Isis for any use of Celera Gene Targets after
Isis is notified to cease use of any Celera Gene Target, any use of Celera Gene
Targets in any Isis database, any use of Celera Gene Targets outside the
Research Plan, or any use of Celera Gene Targets in the development and/or
commercialization of Common Products or Isis Products.
3.2 Selection of Celera Exclusive Targets.
(a) Isis will perform the work described in the Research Plan
and deliver any resulting data to the JRC and the Intellectual Property
Committee in a timely fashion ("Collaboration Data"). Such Collaboration Data
will include the assay and phenotype data as set forth in the Research Plan.
(b) Promptly after receiving the Collaboration Data with regard
to a Celera Gene Target, the JRC and the Intellectual Property Committee will
review the Collaboration Data. Upon delivery of the Collaboration Data, such
Celera Gene Target will become part of a pool of Celera Gene Targets available
to Celera for its use in accordance with the terms of this Agreement (the
"Celera Gene Availability Pool"). If Isis informs the JRC that it is unable to
create an optimized Antisense Inhibitor to such
7
Celera Gene Target and, as a result, will not be delivering Collaboration Data
to the JRC for such Celera Gene Target, such Celera Gene Target will not be
included in the Celera Gene Availability Pool.
(c) Celera will have the option, on a rolling basis, to
designate up to [* ] Celera Gene Targets from the Celera Gene Availability
Pool, together with the Collaboration Data for such Celera Gene Targets, for
Celera's exclusive use ("Celera Exclusive Targets") for Celera Products
pursuant to Section 4.3(a) (the "Option"). For any given Celera Gene Target,
Celera will exercise such Option, if at all, by giving written notice to Isis
during a period commencing on the date that the JRC determines that no further
work will be done on such Celera Gene Target and Isis delivers the
Collaboration Data as outlined in the Research Plan for such target to the JRC
and ending [* ] (the "Option Period"). Celera may replace any Celera Exclusive
Target with any Celera Gene Target in the Celera Gene Availability Pool
provided (i) the number of Celera Exclusive Targets does not [*] and (ii) the
Option Period for any such Celera Gene Target has not expired. For
clarification, only Celera Gene Targets in the Celera Gene Availability Pool
will be subject to the Option. If Celera does not exercise its Option for any
given Celera Gene Target during the applicable Option Period, or if Celera
notifies Isis in writing that it will not exercise its Option for such Celera
Gene Target, such Celera Gene Target will be deemed excluded from the Celera
Gene Availability Pool. After any such exclusion, such Celera Gene Target will
cease to be a Celera Gene Target, and Celera may not exercise its Option with
regard thereto.
ARTICLE 4
LICENSES AND OTHER RIGHTS
4.1 Licenses to Conduct the Research. Subject to the other
provisions of this Agreement, Celera hereby grants to Isis during the Research
Term a nonexclusive worldwide, paid up right and license, without the right to
sublicense, under the Celera Licensed Patents solely to conduct the Research.
4.2 Isis Database. Isis will have the right to commercialize the
Collaboration Data in a database format unless such Collaboration Data (i) is
subject to Celera's Option during the Option Period pursuant to Section 3.2, or
(ii) contains or comprises in whole or in part any Collaboration Data for a
Celera Exclusive Target. Notwithstanding the foregoing, Celera may provide
Isis, upon Isis's written request, with written approval to use any
Collaboration Data in a database format, which would be otherwise restricted
from use under the first sentence of this Section. Isis will inform its
subscribers regarding the Collaboration Data added to the Isis Database
pursuant to this Section 4.2 that Collaboration Patents, if any, associated
with such data are subject to the licensing requirements set forth in Section
4.3.
4.3 Use of the Joint Patents, Collaboration Patents and Other
Data. Both Parties will have the right to practice the Joint Patents and the
Collaboration Patents and use the Collaboration Data and the data provided by
a Party to the other Party pursuant to Section 5.1(c), for internal research
purposes; provided however,
* Confidential Treatment Requested 8
(a) Isis hereby grants Celera an exclusive right and license
(including with regard to Isis), with the right to sublicense and without
obligation to Isis, under Isis's rights in the Joint Patents and the Celera
Exclusive Collaboration Patents, to conduct development on, and to make, have
made, import, use, sell and have sold Celera Products;
(b) Celera hereby grants Isis an exclusive right and license
(including with regard to Celera), with the right to sublicense and without
obligation to Celera, under Celera's rights in the Joint Patents and the
Collaboration Patents, to conduct development on, and to make, have made,
import, use, sell and have sold Isis Products; and
(c) Both Parties will have the right and license, without
obligation of notice or payment to the other Party, to conduct development on,
and to make, import, use, sell and offer for sale Common Products with the
limited right to sublicense solely for development and commercialization.
(d) Celera will have the exclusive right and license (including
with regard to Isis), to grant sublicenses to make, import, use, sell and offer
for sale Common Products under the Celera Exclusive Collaboration Patents
(subject to the provisions of Section 7.2 regarding Revenue Sharing). Isis will
have the exclusive right and license (including with regard to Celera), to
grant sublicenses to make, import, use, sell, and offer for sale Common
Products under the Joint Patents and the Collaboration Patents except the
Celera Exclusive Collaboration Patents (subject to the provisions of Section
1.63 regarding Revenue Sharing).
4.4 License to Celera Licensed Patents. Celera hereby grants Isis a
nonexclusive right and license, without the right to sublicense except in
connection with the sublicense of an Isis Product discovered by Isis alone or
as part of a bona fide drug discovery collaboration, under Celera's rights in
the Celera Licensed Patents, to conduct development on, and to make, have made,
import, use, sell and have sold Isis Products. Notwithstanding the foregoing,
if Isis is unable to generate a Lead Oligo to a Celera Gene Target pursuant to
the Research Plan, any and all Patent Rights that claim such Celera Gene Target
will be excluded from the license set forth in the preceding sentence.
4.5 Negative Covenants.
(a) Isis covenants to Celera that Isis will not research,
develop or commercialize or license any Third Party or an Affiliate to
research, develop or commercialize any Celera Product claimed by Celera
Exclusive Collaboration Patents.
(b) Celera covenants to Isis that:
(i) Celera will not research, develop or commercialize, or
license any Third Party or an Affiliate to research, develop or commercialize
any Isis Product claimed by Collaboration Patents; and
(ii) Celera will not enter into any agreement with any Third
Party whose core business includes the provision of Antisense Inhibitors for
gene functionalization during the Research Term.
9
4.6 Limited Rights. Nothing in this Agreement is intended or will be
interpreted as granting to Isis or any Third Party any right or interest in any
Patent Rights, Information, trade secrets, copyrights, trademarks, trade names
or other intellectual property rights (a) invented, discovered, developed, or
otherwise created by PE Corporation (NY), or its Affiliates, other than by the
Celera Genomics Group, or (b) acquired or licensed by PE Corporation (NY), or
its Affiliates, other than solely for the benefit of the Celera Genomics Group.
ARTICLE 5
OTHER SERVICES
5.1 Supply of Antisense Inhibitors.
(a) Isis will provide Lead Oligo Reagent to each Celera
Exclusive Target and to [* ] Celera Gene Targets that are not Celera Exclusive
Targets claimed by Celera Licensed Patents as provided in Section 4.4, at a
rate of [* ] per order for up to [* ] of a Lead Oligo, for Celera's internal
research and development of Celera Products and/or Common Products as
applicable ("Other Services"). Celera may request and Isis may agree to
negotiate commercially reasonable terms for the provision to Celera of
additional Lead Oligo Reagent to other Celera Gene Targets.
(b) Except as otherwise provided under this Agreement, all such
Antisense Inhibitors delivered to Celera will be used only in furtherance of
the Research, will not be used or delivered to or for the benefit of any Third
Party without the prior written consent of Isis, and will not be used in
research or testing involving human subjects. The Antisense Inhibitors supplied
under this Section 5.1 must be used with prudence and appropriate caution in
any experimental work, since not all of their characteristics may be known.
(c) THE ANTISENSE INHIBITORS BEING PROVIDED TO CELERA HEREUNDER
ARE PROVIDED "AS IS" AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE
MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS
OF ANY THIRD PARTY.
(d) Celera agrees that it will not, nor will it request any
Third Party, to synthesize Antisense Inhibitors to any Celera Gene Target
during the Research Term or for the longer of [ *] thereafter or (ii) such time
as the discovery, manufacture, use or sale of such Antisense Inhibitors would
no longer infringe a Valid Claim of a Patent Right Controlled by Isis.
(e) Antisense Inhibitors discovered under the Research Plan are
identified using patented technology.
*Confidential Treatment Requested 10
(i) During the Research Term and for [*] thereafter (the
"Extended Term"), if Celera derives any Information from research not under the
Research Plan using Lead Oligo Reagent provided by Isis to Celera pursuant to
Section 5.1(a), Celera will promptly provide such Information to Isis.
Notwithstanding the obligation to provide such Information, Celera hereby
grants Isis an exclusive right and license (including with regard to Celera),
without the right to sublicense, except in connection with the sublicense of an
Isis Product discovered by Isis alone or as part of a bona fide drug discovery
collaboration, and without obligation to Celera, under Celera's rights in any
Patents Rights in which information derived using such Lead Oligo Reagent
during and after the Extended Term is used in the filing prosecution,
maintenance or defense of such Patent Rights, to conduct development on, and to
make, have made, import, use, sell and have sold Isis Products.
(ii) During the Extended Term, if Isis derives any
Information from research not under the Research Plan on Celera Exclusive
Targets using Antisense Inhibitors identified under the Research Plan, and/or
on Celera Gene Targets that are claimed by Celera Licensed Patent Rights as
provided in Section 4.4, Isis will promptly provide all data derived from such
research to Celera, excluding data derived from any use in humans.
Notwithstanding the obligation to provide such Information, Isis hereby grants
Celera a non-exclusive right and license, without the right to sublicense,
except in connection with the sublicense of a Celera Product discovered by
Celera alone or as part of a bona fide drug discovery collaboration, and
without obligation to Isis, under any Patent Rights claiming all Information
derived from such research during and after the Extended Term, to conduct
development on, and to make, have made, import, use, sell and have sold Celera
Products.
5.2 Custom Target Validation. Celera will have an option to identify
up to [*] Celera Gene Targets for custom target validation. Custom target
validation may include pharmacology studies of effects of antisense inhibitor
in additional cell-based or animal models. Terms and conditions for custom
target validation will be negotiated in good faith but no less than Isis'
fully-burdened cost plus appropriate milestones and royalties.
ARTICLE 6
MANAGEMENT OF THE COLLABORATION
6.1 Creation and Structure of the Joint Research Committee.
(a) Within ten (10) business days of the Effective Date, the
Parties will create a Joint Research Committee of two (2) persons to facilitate
the research collaboration called for herein. The JRC will consist one (1)
representative nominated by each Party. Members of the JRC may be represented
at any meeting by a designee appointed by such member for such meeting. Each
Party will be free to change its representatives on notice to the other or to
send a substitute representative of equal qualification and authority to any
JRC meeting.
*Confidential Treatment Requested 11
(b) The JRC will meet as necessary but no less frequently than
every three (3) months during the Research Term. Meetings will be via
teleconference or videoconference. At its first meeting the JRC will determine
such procedures as it will reasonably require to conduct its business.
(c) During the Research Term, the JRC will be the primary
vehicle for interaction between the Parties with respect to the Research.
Without limiting the foregoing, the JRC will be responsible for (i) determining
for each Celera Gene Target whether to proceed to conduct Secondary Assays as
described in the Research Plan. (ii) reviewing and commenting upon the patent
filing strategies of the Collaboration Patents, the Celera Exclusive
Collaboration Patents and the Joint Patent Rights as provided in Article 8;
(iii) reviewing and commenting upon publications as contemplated by Section
9.2; and (iv) managing the activities of the Intellectual Property Committee.
The items in Subsections (ii) and (iii) will be delegated to the Intellectual
Property Committee.
(d) All decisions of the JRC will be made by the unanimous vote
of the members. If the members of the JRC cannot agree with respect to a
particular issue such issue will be referred to the JEC which will make a
reasonable good faith effort to reach agreement thereon within a ten (10)
business day period after such issue is presented to the JEC in writing.
6.2 Creation and Structure of the Intellectual Property Committee.
(a) At the first meeting of the JRC, the JRC will create an
Intellectual Property Committee. The Intellectual Property Committee will be
managed and directed by the JRC. The Intellectual Property Committee will be
composed of the two (2) JRC members plus two (2) additional members, one from
each of Isis and Celera.
(b) The roles of the Intellectual Property Committee will be
(i) to conduct the IP mining described in the Research Plan, (ii) to review and
approve any publications containing Collaboration Data except inclusion of
Collaboration Data in the Isis database as anticipated by this Agreement, and
(iii) to manage the prosecution, defense and maintenance of the Collaboration
Patents and the Joint Patents.
(c) The Intellectual Property Committee will meet as needed
either in person, by teleconference or via videoconference. At the first
meeting of the Intellectual Property Committee, the Committee will adopt such
roles and procedures as it may deem necessary or appropriate to conduct their
business.
(d) All decisions of the Intellectual Property Committee will
be made by the unanimous vote of the members, if the members of the
Intellectual Property Committee cannot agree with respect to a particular issue
such issue will be referred to the JEC which will make a reasonable good faith
effort to reach agreement thereon within ten (10) business days after such
issue is presented to the JEC in writing.
(e) The Intellectual Property Committee will continue in effect
after the termination of this Agreement for so long as Collaboration Patents or
Joint Patents are
12
being prosecuted and maintained, or such shorter time as mutually agreed to by
the Parties in writing.
6.3 Creation and Structure of the Joint Executive Committee.
(a) Within ten (10) business days of the Effective Date, the
Parties will create a Joint Executive Committee of two (2) people, one from
each Party to oversee the research collaboration and commercialization
activities called for herein. The JEC will be composed of one (1)
representative appointed by each of Celera and Isis. Either Party may replace
one (1) its representative at any time upon written notice to the other Party
with a person of equal authority and expertise.
(b) The JEC will exist for so long as the JRC or
Intellectual Property Committee is in existence or either Party has the right
to conduct commercialization activities pursuant to Section 4.3(d). The JEC
will meet as requested by the JRC or Intellectual Property Committee. On
matters requiring the approval of the JEC, such approval will be by the
unanimous vote of all JEC members participating in the meeting. In the event
the JEC is unable to reach agreement on all issues, it will be resolved in
accordance with Section 12.11. The JEC will meet within thirty (30) days of
the Effective Date and thereafter as needed or at the request of either Party
to carry out the function set forth in this Section 6.3.
(c) The JEC will be the primary vehicle for oversight of the
research collaboration activities. Without limiting the foregoing, the JEC will
be responsible for (i) review and resolution of any material deviation from the
Research Plan; and (ii) review and resolution of any dispute elevated to it by
the JRC or the Intellectual Property Committee.
(d) Through the JEC the Parties will keep each other reasonably
informed on an ongoing basis of the substantive terms of any proposed agreement
to grant sublicenses pursuant to Section Article 4.3(d).
(i) [*]
(ii) [*]
ARTICLE 7
PAYMENTS AND REVENUE SHARING
7.1 Research Funding.
(a) Celera will pay Isis [*] to conduct the Research under the
Research Plan. Celera will pay Isis [*] of the Effective Date. Notwithstanding
the foregoing, if Isis fails in a material way to conduct the Research
according to the Research Plan Celera may withhold payment of the following [*]
until such material failure is remedied, whereupon such [*] will be paid in
full or in such fraction as the Parties shall reasonably agree. Any
*Confidential Treatment Requested 13
dispute with regard to such payment withholding will be promptly elevated to
dispute resolution pursuant to Section 12.11(a).
(b) Delivery schedule and funding for Other Services described
in Article 5 will be agreed upon and paid in advance in the amounts agreed to
by the Parties.
7.2 [*].
7.3 Mode of Payment and Reports. All payments to hereunder will be
made to the receiving Party within sixty (60) days of the end of the quarter in
which the receiving Party receives the payment by deposit of United States
Dollars in the requisite amount to such bank account as the receiving Party may
from time-to-time designate by notice to the paying Party. The paying Party
will provide to the receiving Party with each such payment a report in
sufficient detail to show the basis for such payment.
7.4 Audits.
(a) Upon the written request of the receiving Party and not
more than once in each calendar year, the paying Party will permit an
independent certified public accounting firm of nationally recognized standing
selected by the paying Party, and reasonably acceptable to the receiving Party
at the receiving Party's expense, to have access during normal business hours,
and upon reasonable prior written notice, to such of the records of the paying
Party as may be reasonably necessary to verify the accuracy of the reports
under Section 7.3 for the prior calendar year only. The accounting firm will
disclose to the Parties only whether the reports are correct or incorrect and
the specific details concerning any discrepancies. No other information will be
provided to Celera.
(b) If such accounting firm concludes that additional payments
were owed during such period, the paying Party will pay the additional
payments, with interest from the date originally due at the prime rate, as
published in The Wall Street Journal (Eastern U.S. Edition) on the last
business day preceding such date, within thirty (30) days after the date the
receiving Party delivers to the paying Party such accounting firm's written
report. [*]
(c) For any sublicense granted by either Party hereunder which
triggers payments to the other Party pursuant to this Article 7, the grantor of
such sublicense will include in each sublicense granted by it pursuant to this
Agreement a provision requiring the Sublicensee to keep and maintain records of
sales made, pursuant to such sublicense and to grant access to such records by
the licensing Party's independent accountant to the same extent required by
such grantor under this Agreement.
(d) Celera and Isis will treat all information subject to
review under this Section 7.4 or under any sublicense agreement in accordance
with the confidentiality provisions of Article 9 of this Agreement.
7.5 Taxes. If any taxes are required to be withheld by the
licensing Party, it will (a) deduct such taxes from the remitting payment,
(b) timely pay the taxes to the proper
*Confidential Treatment Requested 14
taxing authority, and (c) send proof of payment to the receiving Party and
certify its receipt by the taxing authority within sixty (60) days following
such payment.
ARTICLE 8
INVENTIONS AND PATENTS
8.1 Title to Inventions.
(a) Any Patent Rights covering inventions by the Parties during
the Collaboration that do not constitute Collaboration Patents will be owned
exclusively by the inventing party, subject to Subsection 8.1(c).
(b) Joint Patents will be jointly owned, subject to Subsection
8.1(c).
(c) Any inventions constituting Oligonucleotide Patents will be
solely owned and assigned to Isis. Inventions with an antisense component and a
broader compound will be broken into separate patent applications with the
antisense-related inventions filed separately as Oligonucleotide Patents.
(d) Any inventions constituting Celera Exclusive Collaboration
Patents will be solely owned and assigned to Celera (subject to the licenses
granted to Isis hereunder).
(e) Inventorship will be determined by the applicable laws of
the country or jurisdiction in which the particular Patent Right is sought.
(f) In the event that there is a dispute between the Parties as
to ownership under this Section, the Intellectual Property Committee will
establish a procedure to resolve such dispute, which may include engaging a
Third Party patent attorney completely unaffiliated and independent of the
Parties and jointly selected by the Parties, as an expert to resolve such
dispute.
8.2 Patent Prosecution.
(a) The Parties expect that patent applications will be filed
and maintained as required to secure the Collaboration Patent Rights. Celera,
with reasonable and timely input from Isis, will be responsible for filing,
prosecuting and/or maintaining the Celera Exclusive Collaboration Patents
throughout the world. Isis with reasonable and timely input from Celera, will
be responsible for filing, prosecuting and/or maintaining the Collaboration
Patents other than Celera Exclusive Collaboration Patents throughout the world.
Celera and Isis will share equally the costs of filing, prosecuting and/or
maintaining such Patent Rights. Notwithstanding the above, either Party may
decline to pay its share of the costs for filing, prosecuting and/or
maintaining any Collaboration
15
Patent(s) (a "Declining Party"), in which case such Declining Party will
notify the other Party promptly in writing and in good time to enable the
other Party to meet any applicable deadlines, and the other Party will have
the right, but not the obligation, to undertake the responsibility for
filing, prosecuting and/or maintaining such Collaboration Patents at its own
expense, and the Declining Party will reasonably cooperate with and assist
the other Party therein. A Declining Party will maintain its license under
such Collaboration Patent pursuant to Article 4, except that any right to
grant sublicenses therein (other than the sublicensing rights set forth in
Sections 4.3(a) 4.3(b)), and any right to receive Licensing Revenue pursuant to
Section 7.2 under such Collaboration Patents, will terminate as of the date a
Declining Party provides such written notice. Such terminated sublicense
rights shall be granted to the other Party, provided such other Party has
exercised its right of filing, prosecuting and/or maintaining such
Collaboration Patents.
(b) The Parties anticipate that there may be Joint Patents that
arise out of the Collaboration (that do not constitute Collaboration Patents or
Oligonucleotide Patents). To the extent that such a Joint Patent represents an
improvement of one Party's technology and not the other, the Party whose
technology is improved will have the sole right and responsibility, at its own
expense, to prosecute and maintain such Joint Patent. To the extent that such a
Joint Patent either represents an improvement to both Party's technology or
does not improve either Party's technology, the Intellectual Property Committee
will determine which of the Parties will be responsible for prosecution,
maintenance, enforcement and defense of such Patent and what procedures will be
put in place for coordination among the Parties including, without limitation,
cost-sharing and input.
(c) Isis will be solely responsible, at its own expense, for
prosecution, maintenance, defense and enforcement of any Oligonucleotide
Patents.
8.3 Enforcement of Patents.
(a) If either Party considers that any Collaboration Patent is
being infringed by a Third Party, it will notify the other Party and provide it
with any evidence of such infringement which is reasonably available. Subject
to any limitations in the license agreements between Celera or Isis and Third
Party licensors covering licensed Patent Rights, the JEC will determine the
steps to take to attempt to remove such infringement by commercially
appropriate steps, including filing an infringement suit or taking other
similar action.
(b) The Party not enforcing the applicable Patent Rights will
provide reasonable assistance to the other Party, including providing access to
relevant documents and other evidence and making its employees available,
subject to the enforcing Party's reimbursement of any out-of-pocket expenses
incurred by the non-enforcing Party.
(c) Any amounts recovered by a Party pursuant to Section
8.3(a) whether by settlement or judgment, will be allocated in the following
order: (i) to reimburse Isis and Celera for their reasonable out-of-pocket
expenses in making such
16
recovery (which amounts will be allocated pro rats if insufficient to cover the
totality of such expenses); and (ii) the remainder will be allocated as the
Parties will reasonably agree based upon damages suffered.
(d) Except for Third Party infringement activities covered by
the provisions of Section (j) each Party will retain the sole and exclusive
right to enforce its Patent Rights against all infringers at its sole cost and
expense.
ARTICLE 9
CONFIDENTIALITY
9.1 Confidentiality Obligations. Each Party agrees that, for the
term of this Agreement and for five (5) years thereafter, such Party will keep,
and will ensure that its officers, directors, employees and agents keep,
completely confidential and will not publish or otherwise disclose and will not
use for any purpose except as permitted hereunder any Confidential Information
furnished to it by the other Party pursuant to this Agreement (including,
without limitation, Know-How of the disclosing Party). The foregoing
obligations will not apply to any information to the extent that it can be
established by such receiving Party that such information:
(a) was already known to the receiving Party as evidenced by
its written records, other than under an obligation of confidentiality, at the
time of disclosure;
(b) was generally available to the public or was otherwise part
of the public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise
becomes part of the public domain after its disclosure and other than through
any act or omission of the receiving Party in breach of this Agreement;
(d) was subsequently lawfully disclosed to the receiving Party
by a Third Party other than in contravention of a confidentiality obligation of
such Third Party to the disclosing Party; or
(e) was developed or discovered by employees of the receiving
Party or its Affiliates who had no access to the Confidential Information of
the disclosing Party. Each Party may disclose the other's Confidential
Information to the extent such disclosure is reasonably necessary in filing or
prosecuting patent applications, prosecuting or defending litigation, advising
investors and the investment community of the results of the Research aid/or
development activities hereunder (subject to reasonable prior written notice
of, and good faith consultation about, such disclosure to the other Party),
complying with applicable governmental regulations, making a permitted
sublicense of its rights hereunder or otherwise in performing its obligations
or exercising its rights hereunder, provided that if a Party is required to
make any such disclosure of the other Party's Confidential Information, it will
give reasonable advance notice to that other Party of such disclosure
requirement, will cooperate with the other Party in its efforts to secure
confidential treatment of such Information prior to its disclosure, and, save
to the extent
17
inappropriate in the case of patent applications, will use all reasonable
efforts to secure confidential treatment of such information prior to its
disclosure (whether through protective orders or confidentiality agreement or
otherwise).
9.2 Publications.
(a) The Collaboration Data will be the Confidential Information
of Isis and Celera. Either Party may publish or present Collaboration Data
subject to the prior review by the Intellectual Property Committee for
patentability and protection of such other Party's Confidential Information.
The Intellectual Property Committee will review any proposed abstracts,
manuscripts or summaries of presentations which contain Collaboration Data. No
publication or presentation containing Collaboration Data may be submitted or
made without approval by the Intellectual Property Committee. The Intellectual
Property Committee may delay any such approval to ensure protection of Patent
Rights. Notwithstanding the foregoing, nothing contained herein will preclude
Isis from including the Collaboration Data in its marketed database in
accordance with the terms of this Agreement or presenting the Collaboration
Data to Isis' potential customers for such database or in connection with
either Parties active drug discovery programs, without approval of the
Intellectual Property Committee.
(b) To the extent appropriate and within the Party's control,
in any publication permitted under this Section 9.2, each Party will
acknowledge its collaboration with the other Party under this Agreement
9.3 Press Releases. Except to the extent required by law or as
otherwise permitted in accordance with this Section 9.3, neither Party will
make any public announcements concerning this Agreement or the terms hereof
without the prior written consent of the other, which will not be unreasonably
withheld or delayed. Notwithstanding the foregoing, the Parties will issue a
joint press release promptly following execution of this Agreement announcing
(i) the execution of this Agreement; (ii) Celera and Isis will jointly identify
novel gene function utilizing Celera's expertise in genomics and Isis'
expertise in antisense technology; (iii) Celera will retain exclusive rights to
a limited number of genes for the research and development of certain
therapeutic products; and (iv) that functional information on [*] of these
genes will be incorporated into Isis' Gene Function Database, and agree that
each Party may desire or be required to issue subsequent press releases
relating to the Agreement or activities thereunder, and the Parties agree to
consult with each other reasonably and in good faith with respect to the text
and timing of such press releases prior to the issuance thereof, provided that
a Party may not unreasonably withhold consent to such releases, and that either
Party may issue such press releases as it determines, based on advice of
counsel, are reasonably necessary to comply with laws or regulations or for
appropriate market disclosure.
ARTICLE 10
INDEMNIFICATION
*Confidential Treatment Requested 18
10.1 Indemnification by Celera. Celera will indemnify, defend and
hold Isis and its agents, employees, officers and directors (the "Isis
Indemnitees") harmless from and against any and all liability, damage, loss,
cost or expense (including reasonable attorneys' fees) arising out of Third
Party claims or suits related to (a) Celera's performance of its obligations
under this Agreement; or (b) breach by Celera of its representations and
warranties set forth in Section 12.3 or (c) Isis' use of Celera Gene Targets
under the Research Plan pursuant to Section 3.1(d); PROVIDED, HOWEVER, that
Celera's obligations pursuant to this Section 10.1 will not apply to the extent
such claims or suits result from the gross negligence or willful misconduct of
any of the Isis Indemnitees. Notwithstanding the foregoing, Celera will have no
obligation to indemnify the Isis Indemnitees with respect to claims arising out
of breach by Isis of its representations and warranties set forth in Sections
12.3.
10.2 Indemnification by Isis. Isis will indemnify, defend and hold
Celera and its Affiliates and each of their respective agents, employees,
officers and directors (the "Isis Indemnitees") harmless from and against any
and all liability, damage, loss, cost or expense (including reasonable
attorney's fees) arising out of Third Party claims or suits related to (a)
Isis's performance of its obligations under this Agreement; or (b) breach by
Isis of its representations and warranties set forth in Sections 12.3; provided
however, that Isis's obligations pursuant to this Section 10.2 will not apply
to the extent that such claims or suits result from the gross negligence or
willful misconduct of any of the Celera Indemnitees. Notwithstanding the
foregoing, Celera will have no obligation to indemnify the Celera Indemnitees
with respect to claims arising out of a breach by Celera of its representations
and warranties set forth in Section 12.3.
10.3 Notification of Claims. Conditions to Indemnification
Obligations. As a condition to a Party's right to receive indemnification under
this Article 10 it will (i) promptly notify the other Party as soon as it
becomes aware of a claim or action for which indemnification may be sought
pursuant hereto, (ii) cooperate with the indemnifying Party in the defense of
such claim or suit, and (iii) permit the indemnifying Party to control the
defense of such claim or suit, including without limitation the right to select
defense counsel. In no event, however, may the indemnifying Party compromise or
settle any claim or suit in a manner which admits fault or negligence on the
part of the indemnified Party without the prior written consent of the
indemnified Party. The indemnifying Party will have no liability under this
Article 10 with respect to claims or suits settled or compromised without its
prior written consent.
ARTICLE 11
TERMINATION AND EXPIRATION
11.1 Term and Termination. This Agreement will commence upon the
Effective Date and, unless earlier terminated as provided herein, will expire
on the expiration of all royalty and other payment obligations herein.
11.2 Termination upon Material Breach. Failure by a Party to comply
with any of its material obligations contained herein will entitle the Party not
in default to give to
19
the Party in default notice specifying the nature of the default, requiring
it to make good or otherwise cure such default, and stating its intention to
terminate if such default is not cured. If such default is not cured within
ninety (90) days after the receipt of such notice (or, if such default cannot
be cured within such ninety (90) day period, if the Party in default does not
commence and diligently continue actions to cure such default), the Party not
in default will be entitled, without prejudice to any of its other rights
conferred on it by this Agreement, and in addition to any other remedies
available to it by law or in equity, to terminate this Agreement; PROVIDED
HOWEVER, that such right to terminate will be stayed in the event that,
during such ninety (90) day period, the Party alleged to have been in default
will have initiated dispute resolution in accordance with Section 12.11 with
respect to the alleged default, which stay will last so long as the
initiating Party diligently and in good faith cooperates in the prompt
resolution of such dispute resolution proceedings.
11.3 Consequences of Termination.
(a) Upon termination of this Agreement (but not upon expiration
of its term under Section 11.1);
(i) each Party will promptly return all relevant records
and materials in its possession or control containing or comprising the other
Party's Confidential Information and to which the former Party does not retain
rights hereunder (except one copy of which may be retained in a Party's
confidential files in its legal department for archival purposes); and
(ii) all licenses granted under Sections 4.1, 4.1(a) and
4.3(d) will terminate; provided however, that all sublicenses previously
granted will survive termination. All licenses granted under Section 4.2 and
4.3 will survive termination.
(b) The right of a Party to terminate this Agreement, as herein
above provided, will not be affected in any way by its waiver or failure to
take action with respect to any prior default.
11.4 Accrued Rights; Surviving Obligations.
(a) Termination, relinquishment or expiration of this Agreement
for any reason will be without prejudice to any rights which will have accrued
to the benefit of a Party prior to such termination, or expiration. Such
termination, relinquishment or expiration will not relieve a Party from
obligations which are expressly indicated to survive termination or expiration
of this Agreement.
(b) Without limiting the foregoing, Sections 2.3, 3.1(d),
4.3(a), 4.3(b), 4.3(c), 4.5, 4.6, 7.3, 7.4, 7.5, 8.1, 8.2, 9.1, 11.3, 11.4
and 11.5 and Articles 10 and 12 of this Agreement will survive the expiration
or termination of this Agreement for any reason.
11.5 Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by Isis or Celera are, and will otherwise be deemed
to be, for purposes of
20
Section 365(n) of the U.S. Bankruptcy Code, licenses of right to "intellectual
property" as defined under Section 101 of the U.S. Bankruptcy Code. The Parties
agree that the Parties, as licensees of such rights under this Agreement, will
retain and may fully exercise all of their rights and elections under the U.S.
Bankruptcy Code. The Parties further agree that, in the event of the
commencement of a bankruptcy proceeding-by or against either Party under the
U.S. Bankruptcy Code, the Party hereto which is not a party to such proceeding
will be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and same, if not already in their possession, will be
promptly delivered to them (i) upon any such commencement of a bankruptcy
proceeding upon their written request therefor, unless the Party subject to
such proceeding elects to continue to perform all of its obligations under this
Agreement, or (ii) if not delivered under (i) above, following the rejection of
this Agreement by or on behalf of the Party subject to such proceeding upon
written request therefor by the non-subject Party.
ARTICLE 12
MISCELLANEOUS PROVISIONS
12.1 Relationship of the Parties. Nothing in this Agreement is
intended or will be deemed to constitute a partnership, agency or
employer-employee relationship between the Parties. Neither Party will incur
any debts or make any commitments for the other.
12.2 Assignments. Neither this Agreement nor any interest hereunder
will be assignable, nor any other obligation delegable, by a Party without the
prior written consent of the other Party; provided however, that either Party
may assign this Agreement without consent to any successor in interest by way
of merger or sale of all or substantially all of its assets in a manner such
that the assignor will remain liable and responsible for the performance and
observance of all of the assigning Party's duties and obligations hereunder,
except that no intellectual property of any Third Party acquirer of Celera or
Isis will be included in the licenses granted hereunder. This Agreement will be
binding upon the successors and permitted assigns of the Parties. Any
assignment not in accordance with this Section 12.2 will be void.
12.3 Representations and Warranties. Each Party represents and
warrants to the other Party that, as of the date of this Agreement:
(a) Such Party is duly organized and validly existing under the
laws of the state of its incorporation and has full corporate power and
authority to enter into this Agreement and to carry out the provisions hereof;
(b) Such Party has taken all corporate action necessary to
authorize the execution and delivery of this Agreement and the performance its
obligations under this Agreement;
(c) This Agreement is a legal and valid obligation of such
Party, binding upon such Party and enforceable against such Party in accordance
with the terms of this Agreement The execution, delivery and performance of
this Agreement by such
21
Party does not conflict with any agreement, instrument or understanding, oral
or written, to which such Party is a party or by which such Party may be bound,
and does not violate any law or regulation of any court, governmental body or
administrative or other agency having authority over such Party. All consents,
approvals and authorizations from all governmental authorities or other Third
Parties required to be obtained by such Party in connection with this Agreement
have been obtained
(d) It has the full and exclusive right, power and authority to
enter into this Agreement, to perform the Research and to grant the licenses
granted under Article 4;
(e) There are no agreements between such Party and any Third
Parties which would preclude or otherwise limit such Party's ability to conduct
its tasks and obligations under the Research Plan or otherwise fulfill its
obligations under this Agreement;
(f) All individuals who will perform any activities on its
behalf in connection with the Research have assigned to it or its Affiliates
the whole of their rights in any intellectual property conceived or reduced to
practice by them as a result of the Research, and no Third Party will have any
rights to any such intellectual property.
12.4 Disclaimer of Warranties. THE PARTIES EXPRESSLY DISCLAIM ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD
PARTY RIGHTS, UNLESS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT.
12.5 Further Actions. 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.
12.6 Force Majeure. Neither Party will be liable to the other for
failure or delay in the performance of any of its obligations under this
Agreement for the time and to the extent such failure or delay is caused by
earthquake, riot, civil commotion, war, strike, flood, governmental acts or
restrictions or any other reason which is beyond the control of the respective
Party. The Party affected by force majeure will provide the other Party with
full particulars thereof as soon as it becomes aware of the same (including its
best estimate of the likely extent and duration of the interference with its
activities), and will use commercially reasonable efforts to overcome the
difficulties created thereby and to resume performance of its obligations as
soon as practicable. If the performance of any obligation under this Agreement
is delayed owing to a force majeure for any continuous period of more than six
(6) months, the Parties hereto will consult with respect to an equitable
solution, including the possibility of the mutual termination of this
Agreement.
12.7 No Trademark Rights. Except as expressly set forth herein, no
right, express or implied, is granted by this Agreement to a Party to use in
any manner the name or any other trade name or trademark of a Party in
connection with the performance of this Agreement.
22
12.8 Entire Agreement of the Parties; Amendments. This Agreement and
the exhibits hereto constitute and contain the entire understanding and
agreement of the Parties respecting the subject matter hereof and cancel and
supersede any and all prior negotiations, correspondence, understandings and
agreements between the Parties, whether oral or written, regarding such subject
matter. No waiver, modification or amendment of any provision of this Agreement
will be valid or effective unless made in writing and signed by a duly
authorized officer of each Party.
12.9 Captions. The captions to this Agreement are for convenience
only, and are to be of no force or effect in construing or interpreting any of
the provisions of this Agreement
12.10 Applicable Law. This Agreement will be governed by and
interpreted in accordance with the laws of the State of Delaware, USA,
applicable to contracts entered into and to be performed wholly within the
State of Delaware, excluding conflict of law principles.
12.11 Disputes. In the event of any controversy or claim arising out
of, relating to or in connection with any provision of this Agreement or the
rights or obligations of the Parties hereunder, the Parties will try to settle
their differences amicably between themselves as contemplated herein. To the
extent not provided for herein, either Party may initiate such informal dispute
resolution by sending written notice of the dispute to the other Party, and
within ten (10) days after such notice.
(a) The Chief Business Officer of Celera and the President of
GeneTrove of Isis will meet for discussion and resolution. If such personnel
are unable to resolve such dispute within thirty (30) days of initiating such
negotiations, the Parties agree to settle any unresolved controversy or claim
arising out of, relating to or in connection with this Agreement (except as to
any issue relating to the ownership of intellectual property of either Party)
in Dallas, Texas by binding arbitration under the American Arbitration
Association in accordance with its Commercial Arbitration Rules as modified by
this Section, and judgment upon the award rendered by the arbitrators may be
entered in any court having jurisdiction thereof. Within fifteen (15) days
after the commencement of arbitration, each Party will select one (1) person to
act as arbitrator, and the two (2) selected by the Parties will select a third
arbitrator within ten (10) days of their appointment. The Parties agree that in
cases in which this Agreement explicitly provides that their disagreement will
be settled by this Section, the arbitration method to be employed will be
"baseball-style arbitration." This means that each Party will submit in writing
to the Panel and the other Party at an appropriate time its final, detailed
proposed resolution of the dispute. The panel will have the right to ask for
and receive (at the same time as the other Party) clarification of a Party's
proposed resolution. In its arbitration award, the panel will be limited to
choosing, without material modification, one of the two proposed resolutions,
together with an award of reasonable attorneys' fees to the prevailing Party.
The arbitrators will have no authority to award punitive damages or any other
damages not measured by the prevailing Party's actual damages, and may not, in
any event, make any ruling, finding or award that does not conform to the terms
and conditions of this Agreement. Neither Party nor the arbitrators may
disclose the existence,
23
content, or results of any arbitration hereunder without the prior written
consent of both Parties.
12.12 Notices and Deliveries. Any notice, request, delivery, approval
or consent required or permitted to be given under this Agreement will be in
writing and will be deemed to have been sufficiently given if delivered in
person, transmitted by facsimile (receipt verified) or by express courier
service (signature required) or five (5) days after it was sent by registered
letter, return receipt requested (or its equivalent), to the Party to which it
is directed at its address or facsimile number shown below or such other
address or facsimile number as such Party will have last given by notice to the
other Party.
If to Isis, addressed to:
Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxx Xxxxx, B. Xxxxx Xxxxxxxx
Cc: GeneTrove President
If to Celera, addressed to:
Celera Genomics
00 Xxxx Xxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx
Attn: Xxxxx Xxxxxxx, Ph.D.
Cc: Group Counsel, Legal Affairs
12.13 No Consequential Damages. IN NO EVENT WILL EITHER PARTY OR ANY
OF ITS RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS
AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER
IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE,
INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR REVENUE, OR CLAIMS OF
CUSTOMERS OF ANY OF THEM OR OTHER THIRD PARTIES FOR SUCH OR OTHER DAMAGES.
12.14 Non-Solicitation. During the Research Term, and for a period of
one (1) year thereafter, neither Party will solicit, induce, encourage or
attempt to induce or encourage any employee of the other Party to terminate his
or her employment with such other Party or to breach any other obligation to
such other Party.
12.15 Waiver. A waiver by either Party of any of the terms and
conditions of this Agreement in any instance will not be deemed or construed to
be a waiver of such term or condition for the future, or of any subsequent
breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Agreement will be cumulative and none of them will be in
limitation of any other remedy, right, undertaking, obligation or agreement of
either Party.
24
12.16 Compliance with Law. Nothing in this Agreement will be deemed
to permit a Party to export, re-export or otherwise transfer any Licensed
Product sold under this Agreement without compliance with applicable laws.
12.17 Severability. When possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement is held to be prohibited
by or invalid under applicable law, such provision will be ineffective only to
the extent of such prohibition or invalidity, without invalidating the
remainder of this Agreement. The Parties will make a good faith effort to
replace the invalid or unenforceable provision with a valid one which in its
economic effect is most consistent with the invalid or unenforceable provision.
12.18 Counterparts. This Agreement may be executed simultaneously in
any number of counterparts, any one of which need not contain the signature of
more than one Party but all such counterparts taken together will constitute
one and the same agreement
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers as of the day and year
first above written, each copy of which will for all purposes be deemed to be
an original.
ISIS PHARMACEUTICALS, INC. PE CORPORATION
By: By:
---------------------------- ----------------------------
(signature) (signature)
Name: B. Xxxxx Xxxxxxxx Name: Xxxxx Xxxxxxx, Ph.D.
Title: Executive Vice President Title: E.V.P. and Chief Business Officer
Date: Date:
--------------------------- --------------------------
25
EXHIBIT A
RESEARCH PLAN
This Exhibit A to the Collaborative Research and License Agreement (the
"Agreement") dated as of July 9, 2001 addresses the conduct of the Research.
Capitalized terms will have the meanings set forth in the Agreement.
The generation of functional information on [* ] Celera Target Genes will follow
a multi-step process: prioritization of genes, generation and validation of lead
antisense oligos, and bioassay readout in four therapeutic areas (cancer,
angiogenesis, inflammation, and metabolic disease). After the Collaboration Data
is reviewed by the Joint Research Committee and Intellectual Property Committee
and appropriate patent applications filed, the information will be used to
populate the Gene Trove Gene Function Database, excluding information on [* ]
Celera Exclusive Targets.
Isis will provide reports to the JRC on a quarterly basis or more frequently.
These reports will contain all information necessary to keep the JRC fully
informed regarding the performance of the research plan.
[*]
*Confidential Treatment Requested 26
EXHIBIT B
[* ]
* Confidential Treatment Requested 27
