Contract
[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
Exhibit 10.34
June
30, 2010 (the “Effective Date”)
In the
interest of commencing the Project, the Parties have executed this Agreement in
short form, recognizing that they are legally bound to the following terms and
conditions. At the request of either Party, the Parties will promptly negotiate
in good faith an expanded version of this Agreement containing additions terms
and conditions customary to agreements of this nature and mutually agreed by the
Parties.
1. PARTIES
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Nitto
Denko Corporation (“Nitto”), whose address
is XXXXXX XXXXX, 0-0-00, Xxxxx, Xxxx-xx, Xxxxx; and
Quark
Pharmaceuticals, Inc. (“Quark”), whose address
is 0000 Xxxxxxxxx Xxxxxx, Xxxxxxx, XX 00000, XXX.
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2. OBJECTIVES
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As
more fully described below, Nitto is interested in developing siRNA
product(s) based on the suppression of the “Nitto Target Genes” (as
defined below) alone or in combination with each other and/or with other
genes (the “Products” as defined below). Quark has the know-how and the
relevant intellectual property to generate and develop such products and
has been performing a feasibility study for Nitto in this respect under
the Collaborative Research Agreement dated the [*] as ammended between the
Parties (the “Prior Agreement”).
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Therefore,
Nitto and Quark hereby enter into a License and Collaboration Agreement
(the “Agreement”), pursuant to which the parties will collaborate to
develop the Product(s) for commercialization by Nitto. The Agreement
covers all stages of Product discovery and development activities as will
be defined more in detail below until the first IND is approved for the
first Product in the name of Nitto (the “Project”). Nitto, at its sole
discretion, shall have the right to decide at each stage whether it wishes
to proceed to the following stage or terminate the Agreement at the
conditions set forth in Section 7.
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3. DEFINITIONS
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3.1 “Background
IP”
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The
patents and patent applications and all other proprietary information, and
know-how owned or controlled (including but not limited to IP jointly
owned by a Party with a third party) by a Party or its affiliates and, in
the case of patents and patent applications, filed before the execution
date of the Agreement, that are reasonably necessary or useful for the
execution of the Project, except any Jointly Owned IP (as defined below)
under the Prior Agreement.
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3.2 “Change
of Control”
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(1)
An acquisition of Quark by another entity by means of merger,
consolidation, or a purchase of all or substantially all of its assets, or
(2) an acquisition of a majority of the outstanding voting stock of Quark
by a single entity acting alone or together with its affiliates
(excluding, however, any current stockholder of Quark or affiliates of a
current stockholder).
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3.3 “Compound”
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Any
siRNA compound directed to one or more Nitto Target Genes (as defined
below), generated during or as a result of the Prior Agreement or this
Agreement or through the use of any know how and intellectual property
generated under this Agreement or the Prior Agreement.
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3.4 “Conjugated
Compound”
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A
Compound conjugated with [*].
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3.5 “Field”
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Treatment,
prevention and diagnosis of [*].
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3.6 “First
Commercial Sale”
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The
first commercial sale in an arms-length transaction of the first Product
in a country after receipt by Nitto or any of its affiliates or
sublicensees of regulatory approval in such country.
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3.7 “Formulation”
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A
Compound formulated together with a [*] owned or controlled by Nitto (such
[*]), together with [*].
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3.8 “Jointly Owned
IP”
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Patents
and patent applications and all other proprietary information owned
jointly by the Parties as a result of the Prior Agreement or this
Agreement.
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3.9 “Net
Sales”
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The
gross amount invoiced by Nitto or its affiliates or sublicensees on sales
or other dispositions of Products to third parties which are not
affiliates in those countries, less customary deductions (such as actual
bad debts, sales returns quantity and cash discounts, rejected goods,
recalls, returns, rebates, chargebacks, reimbursements or similar payments
granted or given to wholesalers or other distributors, customs or excise
duties, sales and use taxes included within the gross amount invoiced, and
charges for freight and insurance].
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3.10 “Nitto Target
Genes”
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· [*]
Additional
Nitto Target Genes may be nominated by either Party and added by mutual
agreement.
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3.11 “Product”
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Any
product in pharmaceutical dosage form, containing one or more Compounds
alone or in any combinations thereof that is being developed for potential
commercialization in the Field. Products shall include the Formulation and
the Conjugated Compound if these are elements of the pharmaceutical dosage
form.
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3.12 “Project”
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The
aggregate of research and development tasks in stages as detailed below
for the development of a Product in the Field. The detailed research and
development plan shall be attached to the Agreement as Appendix A and
includes the
followings:
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
2
Stage 1. All
necessary tasks needed to [*] including [*] as well as [*]; Quark’s last
task in this Stage 1 is [*] for [*] for [*] that is scheduled at the
latest by [*]. Stage 1 is scheduled to end on [*], 2011;
and
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Stage 2. All
necessary tasks needed to [*]. Stage 2 is scheduled to end on [*];
and
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Stage 3. All
necessary tasks needed to complete all IND-enabling activities, including
[*], and obtaining the legal right to commence human clinical trials of
Product under the IND, in the name of Nitto. Stage 3 - that is submission
of IND application in the name of Nitto - is scheduled to end on [*],
2012.
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Appendix
A also specifies which tasks will be performed by Quark and which
will be performed by Nitto as well as the timelines of all tasks and
deliverables.
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Appendix B
attached to this Agreement is the Budget of Quark tasks according to Appendix
A.
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3.13 “Quark Licensed
IP”
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The
patents and patent applications identified on the attached Exhibit 1, that
are part of Quark Background IP, and all other proprietary information,
and know-how owned or controlled by Quark or its affiliates as of the
execution date of the Agreement or thereafter during the term of the
Agreement that are reasonably necessary or useful for the research,
development, manufacture, use, importation or sale of Compound,
Formulation or Product in the Field, excluding, however, Jointly Owned
IP.
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3.14 “Territory”
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Worldwide.
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4. GENERAL
TERMS FOR PERFORMANCE OF R&D ACTIVITIES
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4.1 Governance of Research and
Development
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Nitto
and Quark will form a Joint Development Committee (“JDC”) composed of
members of both Parties and chaired by a Nitto representative, to review
and discuss all development and intellectual property protection
activities including but not limited to achievement of the Project aims
set forth at each stage of this Project (the “Project Goals”) and changes
to be implemented in the program (thus changing the Appendix A attached
hereto) as well as changes to the Budget, if necessary, to reflect changes
in the Project program. It is agreed between the Parties, however, that
changes to the Budget will have to be approved by each Party’s management.
The JDC will meet once every [*] or as otherwise determined by its
members, at times and locations to be determined. Each Party will bear its
own expenses associated with the preparation and meetings of the JDC
meetings. If the Parties are unable to agree, [*] provided that [*], and
provided further that the JDC shall not have authority to [*] assigned to
[*] in the Project to any material degree without the consent of
[*].
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
3
The
JDC shall not have any authority to amend the terms of the Agreement.
Following the completion of Stage 3, the JDC shall continue to meet
periodically solely for advisory purposes, and Quark shall have the right
to discontinue its participation upon written notice, in which case the
JDC shall disband.
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4.2 Performance
of the R&D, Quark Undertakings
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Quark
will use diligent efforts to carry out all of its tasks in the Project in
a timely and effective manner. If the Project will contemplate tasks to be
performed by Nitto, Nitto will make a similar
undertaking.
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Quark
will nominate the key personnel to implement the Project (the “Project
Team”), which will include a Project Manager and liaison manager (window
person) for the communication between Nitto and Quark. The organization of
the Project Team is attached to this Agreement as Appendix C.
Nitto will also nominate a Project Manager and a window person for the
smooth communication between the Parties.
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Both
Parties may change Project Manager and window person according to the
Project stage being performed.
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4.3 Reporting
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During
the Agreement, Quark shall keep Nitto informed of, and promptly provide,
all data and information relating to the Compounds, Formulation, Products
and Conjugated Compound that Quark generates. If the Project will
contemplate tasks to be performed by Nitto, Nitto shall keep Quark
informed of, and promptly provide, all data and information relating to
the specific tasks that Nitto will perform. Nitto will also provide to
Quark any other data, information and materials controlled by Nitto that
are reasonably necessary for Quark to carry out its tasks under the
Project.
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For
such purpose, the window persons of the Parties shall be in close contact
with each other at all times and communicate with each other’s
representatives by email or telephone frequently (daily if required).
Absent unusual developments, written summary progress reports shall be
provided by both Parties through the mechanism of JDC meetings
([*]).
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Quark
will submit detailed reports as follows:
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Upon
the end of the task [*], as stated in section 3.12, Quark shall submit to
Nitto a detailed report (the “[*] Report”). Upon the end
of Stage 1 Quark shall submit a detailed Stage 1 report (the “Stage 1 Final Report”)
to the JDC. This Stage 1 Final Report together with the [*] shall be the
basis for Nitto decision whether to move forward to Stage 2 as provided in
paragraph 7.2.(iii).(a).
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
4
In
the event that Nitto decides to continue to Xxxxx 0, xx xxx xxx xx Xxxxx 0
Xxxxx will submit a second detailed final report (the “Stage 2 Final Report”)
to the JDC. This Stage 2 Final Report shall be the basis for Nitto
decision whether to move forward to Stage 3 as provided in paragraph
7.2.(iii).(b).
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In
the event that Nitto decides to continue to Stage 3, at the end of Stage
3, a third detailed final report (the “Stage 3 Final Report”)
will be submitted to the JDC. Upon submission of the IND for a Product
Quark shall provide to Nitto the full IND documentation(s). The Stage 3
Final Report shall be a basis for Nitto decisions provided in paragraph
7.2.(iii).(c).
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4.4 Intellectual
Property
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Each
Party will own and continue to maintain its Background IP at its own
expense.
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With
respect to new intellectual property (including patents), arising out of
the performance of this Agreement (a) inventorship will be determined
according to the US laws and regulations relating to patents; and (b) such
new intellectual property will be jointly owned by Nitto and Quark on an
equal basis. The Jointly Owned IP patents and patent applications will be
filed by Quark in the name of both Nitto and Quark, and maintained by
Quark in close consultation with Nitto. Quark shall have primary rights to
enforce the Joint IP and handle litigation in close consultation with
Nitto and shall have the primary rights to defend third party claims
against the foregoing. Nitto and Quark shall share all expenses related to
intellectual property protection on an equal basis, including filing,
maintaining patent applications and patents and all costs associated with
litigation related to Jointly Owned IP, including interferences and other
administrative proceedings.
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4.5 Quark’s
Warranty/ Covenant
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As
of the Effective Date, Quark represents and warrants to Nitto
that:
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1)
Quark has neither contracts nor obligation with any third party, which
would conflict with, result in any violation of, or give rise to an
adverse effect on, this Agreement, and will not enter into or establish
any such contract or obligation during the term of this
Agreement.
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2)
Quark understands Nitto’s purpose to develop a new drug for humans using
the results of the Project, and therefore Quark shall conduct, and shall
use reasonable efforts to cause its contractors and consultants to
conduct, all its activities contemplated under this Agreement in
accordance with (i) all applicable Laws of the country in which such
activities are conducted, and (ii) known or published standards of the
applicable Governmental Authority of such
country.
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
5
3)
The composition of the Compound selected by Quark for development under
the IND will not infringe any third party IP. With respect to the Product,
the Parties recognize that (i) the Formulation has been developed by Nitto
and (ii) the elements of the Conjugated Compound, Formulation and Product
have not yet been determined. However, to the best knowledge of Quark, in
reliance on the assumption that [*] does not [*], Quark will be able
to
select a Conjugated Compound and Product that does not infringe any third
party IP. [*]
shall [*] and report the result of [*] to [*] as rapidly as
possible.
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4.6 Clinical
Development
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After
the IND, Nitto will be responsible for diligently conducting, at its sole
expense, the remaining clinical and other development of the Product.
Nitto shall report [*] to Quark the development progress and future
development and commercialization plans. Nitto may request Quark to
perform for Nitto part or all of such clinical trial. In such case, if
Quark will accept Nitto’s offer, the Parties shall agree on the cost and
other terms of Quark’s participation in the clinical development. It is
clarified that the terms of the license granted to Nitto in this Agreement
shall remain the same even if Quark performs part or all of the clinical
development.
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4.7
Commercialization
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Nitto
will be solely responsible for the commercialization of the Product in the
Field and Territory, including regulatory, manufacturing, marketing and
sales activities, subject only to the terms of this
Agreement.
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4.8 Exclusivity of
Research
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During
the term of this Agreement, and thereafter if Nitto purchases the share of
Quark’s ownership of the jointly Owned IP and the grant of non-exclusive
license of Quark Licensed IP in accordance with subsections 7.2 (iii)(a)
through (d) or subsection 7.2 (iv)(c), or if Nitto terminates this
Agreement because of Quark’s Change of Control or Quark’s material breach
in accordance with subsection 7.2 (i) or 7.2 (ii) respectively, neither
Quark nor any of its affiliates shall, directly or indirectly, whether on
its own or with a third party, perform any research with respect to, or
develop or commercialize, the Nitto Targets, Formulation, Products or
Nitto Target-directed siRNA.
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5. LICENSE
TO NITTO
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5.1 Licenses
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Subject
to the terms and conditions of the Agreement:
(i)
Quark hereby grants Nitto, as of the Effective Date, an exclusive
worldwide, royalty-bearing license, with the right to sublicense, under
any Jointly Owned IP, to develop, make, have made, use, sell, have sold,
offer for sale and import such Products in the Field in the Territory.
This is license is subject to Quark’s use of Jointly Owned IP for internal
research purposes and for other purposes outside of the scope of the
foregoing
license.
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
6
(ii)
Furthermore, Quark hereby grants, Nitto, as of the Effective Date, a
non-exclusive worldwide, royalty-bearing license under Quark Licensed IP,
for the sole and exclusive purposes to develop, make, have made, use,
sell, have sold, offer for sale and import such Products in the Field in
the Territory. Such license is granted with the limited right to
sublicense only in conjunction with the sublicensing under (i) above. It
is clarified that during the term of this Agreement, Quark undertakes that
it shall not grant similar license to any third party for research,
development and commercialization of siRNA compounds directed to Nitto
Targets in the Field in the Territory. Except as specifically indicated in
this subsection, Quark shall remain fully free to use, transfer rights and
exploit the Quark Licensed IP without accounting to
Nitto.
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6. FINANCIAL
PROVISIONS
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6.1 Research
Funding
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As
partial compensation for performing the Project by Quark, according to
Appendix A but not including [*], Nitto shall pay to Quark the total sum
of United States Dollars [*] (the “Initial Research Funding”) provided
that if and when the [*], then additional United States Dollars [*] shall
be added to the Initial Research Funding for a total sum of United States
Dollars [*] for the full Project in Appendix A (the “Full Research
Funding”), such additional [*] shall be paid to Quark within [*] after
such JDC approval. The Initial Research Funding shall be paid by Nitto in
installments as follows :
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(i)
United States Dollars two million, two hundred thousand only
(US$2,200,000) upon receipt of Nitto of Quark’s invoice containing its
designated bank account information within [*] from the Effective
Date.
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(ii) United
States Dollars [*], upon receipt by Nitto
of Quark’s invoice containing its designated bank account information,
within [*] from the date of [*].
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(iii) United
States Dollars [*], upon receipt by Nitto of Quark’s invoice containing
its designated bank account information, within [*] from the date of
[*].
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(iv) United
States Dollars [*] upon receipt by Nitto of Quark’s invoice containing its
designated bank account information, within [*] from the date of
[*].
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
7
(v)
United States Dollars [*] upon receipt by Nitto of Quark’s invoice
containing its designated bank account information, within [*] from the
date of [*].
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(vi)
United States Dollars [*] upon receipt by Nitto of Quark’s invoice
containing its designated bank account information, within [*] from the
date of [*].
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(vii)
United States Dollars [*] upon receipt by Nitto of Quark’s invoice
containing its designated bank account information, within [*] from the
[*].
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(viii)
United States Dollars [*] upon receipt by Nitto of Quark’s invoice
containing its designated bank account information, within [*] from the
date [*].
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The
JDC shall [*].
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6.2 Milestone
Payments
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If
Nitto has not elected to purchase the ownership interest of Quark in the
Jointly Owned IP and to obtain the non-exclusive license under the Quark
Licensed IP, by payment of any of the lump sums provided in subsection
7.2.(iii)(a) or (b) within [ *
], Nitto and Quark will discuss in good faith and determine the details of
the milestone payments with respect to the Product (the “Milestone
Payment”) [ * ]. In the event that the Parties are unable to achieve
agreement on the Milestone Payments [ * ], the Parties shall engage an
arbitrator under Section 8.1.
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6.3 Payments in case of
sublicensing
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If
Nitto has not elected to purchase the ownership interest of Quark in the
Jointly Owned IP and to obtain the non-exclusive license under the Quark
Licensed IP, by payment of any of the lump sums provided in subsection
7.2.(iii) (a) or (b) within
[ * ], Nitto and Quark will discuss in good faith and determine the
details of the sublicensing payments with respect to the Product (the
“Sublicensing Payment”), in case of sublicensing by Nitto of the Product
to a third party, [ * ]. In the event that the Parties are unable to
achieve agreement on the Sublicensing Payments [ * ], the Parties shall
engage an arbitrator under Section 8.1.
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6.4 Royalties
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Nitto
will pay a royalty on annual Net Sales (by Nitto or its affiliates or
sublicensees) of the Products at the rate of [*] on a country-by-country
basis.
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Royalties
will be payable for the period from the First Commercial Sale of the
Product until the later of (a) 10 years and (b) the last to expire patent
of the Jointly Owned IP.
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6.5 Royalty
Reductions
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The
royalties will be reduced to [*] of the royalty rate in Section 6.4 above
on a country-by-country basis if there is no patent issued within the
Jointly Owned IP or the Quark Licensed IP in a country, or there is
generic competition in a country, with respect to the Products. However,
such royalty reduction shall not apply if there is [*] (which has been [*]
for not more than [*]) and there is no generic
competition.
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If
Nitto determines that it must acquire rights of third party IP in order to
research, develop, manufacture, use, import, sell or otherwise
commercialize the Product (for reasons other than IP covering the [*]),
Nitto shall have the right to acquire such rights through a license or
otherwise and deduct from the payments due to Quark [*] of the amounts
paid by Nitto to such third party, subject to a maximum reduction limit so
that royalties payable to Quark are not reduced by more than
[*].
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
8
6.6 Reporting
and Audit Rights
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Nitto
shall submit reports of Net Sales and make royalty payments on a quarterly
basis within [*] after the end of each calendar quarter. Quark shall have
the right to audit the Net Sales of Nitto and its sublicensees at its own
expense, provided that Nitto shall bear the expenses of any audit that
establishes an underpayment of more than [*].
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7. TERM
AND TERMINATION
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7.1 Term
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The
term of the Agreement will commence upon execution and continue until the
expiration of the royalty obligations of Nitto, unless earlier terminated
as permitted by the Agreement.
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7.2 Termination
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(i)
Termination for Change of
Control: In the event of a Change of Control of Quark prior to the
completion of Xxxxx 0, Xxxxx shall notify Nitto of such event in writing
immediately and cause such third party acquiring the control of Quark to
deliver to Nitto a written commitment to comply with this Agreement. If
Quark fails to do so, Nitto shall have the right to terminate promptly the
Agreement. In case of termination, all Jointly Owned IP shall be
completely assigned to Nitto for the development, commercialization and
sale of Products in the Field, unconditionally and without any fee and
compensation. Quark undertakes to process such assignment of its share in
the Jointly Owned IP expeditiously and to provide to Nitto rights and
title to all the results, documents, etc. related to the Product in the
Field. In addition Quark shall provide a non-exclusive worldwide,
royalty-free license of any Quark Licensed IP that may be necessary for
development, commercialization and sale of the Product in the
Field.
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(ii)
Termination for Cause
(Material Breach): Either Party will have customary rights to
terminate the Agreement in the event of material breach of the other Party
(subject to a [*] cure period). Either Party terminated by the other Party
under this subsection shall transfer or assign its share of the Jointly
Owned IP to the other Party unconditionally and without any fee and
compensation. In case of the termination by Nitto of this Agreement due to
Quark’s material breach, including but not limited to a material violation
of Quark’s warranty and covenant set forth in Section 4.5, Quark shall
provide to Nitto a non-exclusive worldwide, royalty-free license of any
Quark Licensed IP that may be necessary for development, commercialization
and sale of the Product. The scope of material breach if any and its
damages shall be settled by mutual consultation of both Parties, and if
not settled, by an arbitration set forth in Section 8.1, in addition to
any other remedies provided under New York
law.
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
9
In
the event of a dispute about whether a material breach has occurred,
termination of this Agreement shall not be effective until after an
arbitration under Section 8.1 has determined that a material breach
occurred and was not cured on a timely basis.
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(iii)
Termination by Nitto
Without Cause: Nitto may terminate this Agreement and the Licenses
herein without cause, entirely at the following times (at the end of each
Stage) and conditions.
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(a)
After
completion of Stage 1 but before completion of Stage 2: Within [*]
after [*] at the end of Stage 1 or [*] after the receipt by Nitto of the
Stage 1 Final Report, whichever comes first, Nitto will inform Quark in
writing if Nitto wishes to proceed on to Stage 2. It is clarified that
during this [*] period, Quark will continue the research and development
of the Project according to Appendix A. In the event that Nitto decides to
not to continue to Stage 2, this Agreement shall automatically terminate.
Nitto may purchase the share of the ownership of Quark of the Jointly
Owned IP and, furthermore, Quark will grant Nitto a non-exclusive license
under the Quark Licensed IP for researching, developing, commercializing,
and sale of Products in the Field in the Territory, all provided that
Nitto shall pay an irrevocable amount of United States Dollars [*]. Nitto
shall advise Quark of its election to purchase such IP and license rights,
and make the related payment (if it elects to purchase such IP and license
rights) within [*] following termination of this Agreement. Even after
such purchasing, the Quark’s obligation for the maintenance, enforcement
and handling litigation relating to such IP shall remain in effect,
provided however that Nitto shall bear all expenses related to the above
intellectual property protection. For the avoidance of doubt, if Nitto
purchases such IP, Nitto shall evade paying royalty, Sublicensing Payment
and Milestone Payment hereunder to Quark. If Nitto decides not to proceed
to Stage 2 or does not purchase the Quark’s share of the Jointly Owned IP,
[*] and the non-exclusive license of Quark Licensed IP to Nitto under
subsection 5.1(ii) shall automatically
terminate.
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
10
(b)
After
completion of Stage 2 but before completion of Stage 3: Within [*]
after the receipt by Nitto of the Stage 2 Final Report, Nitto will inform
Quark in writing if Nitto wishes to proceed to Stage 3. In the event that
Nitto decides not to continue to Stage 3, this Agreement shall
automatically terminate. Nitto may purchase the share of the ownership of
Quark of the Jointly Owned IP and, furthermore, Quark will grant Nitto a
non-exclusive license under the Quark Licensed IP for researching,
developing, commercializing and sale of Products in the Field in the
Territory, all provided that Nitto shall pay an irrevocable amount of
United States Dollars [*]. Nitto shall advise Quark of its election to
purchase such IP and license rights, and make the related payment (if it
elects to purchase such IP and license rights) within [*] following
termination of this Agreement. Even after such purchasing, the Quark’s
obligation for the maintenance, enforcement and handling litigation
relating to such IP shall remain in effect, provided however that Nitto
shall bear all expenses related to the above intellectual property
protection. For the avoidance of doubt, if Nitto purchases such IP, Nitto
shall evade paying royalty, Sublicensing Payment and Milestone Payment
hereunder to Quark If Nitto decides not to proceed to Stage 3 or does not
purchase the Quark’s share of the Jointly Owned IP, [*] and the
non-exclusive license of Quark Licensed IP to Nitto under subsection
5.1(ii) shall automatically terminate.
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(c)
After
completion of Stage 3 and submission of IND in the name of Nitto.
Nitto may terminate the Agreement on [*] prior written notice at any time
after the submission of the IND. In such case Nitto may purchase the share
of the ownership of Quark of the Jointly Owned IP and, furthermore, Quark
will grant Nitto a non-exclusive license under the Quark Licensed IP for
researching, developing, commercializing, and sale of Products in the
Field in the Territory, all provided that Nitto shall pay an irrevocable
amount of United States Dollars [*]. Nitto shall advise Quark of its
election to purchase such IP and license rights, and make the related
payment (if it elects to purchase such IP and license rights) within [*]
following termination of this Agreement. Even after such purchasing, the
Quark’s obligation for the maintenance, enforcement and handling
litigation relating to such IP shall remain in effect, provided however
that Nitto shall bear all expenses related to the above intellectual
property protection. For the avoidance of doubt, if Nitto purchases such
IP, Nitto shall evade paying royalty, Sublicensing Payment and Milestone
Payment hereunder to Quark. If Nitto decides not to purchase the Quark’
share of the Jointly Owned IP and license for the price indicated in this
sub-section, then the provisions of section 7.2(iii)(e) below shall
apply.
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(d)
Quark
Bankruptcy or Insolvency. In the event of the bankruptcy or
insolvency of Quark prior to the completion of Stage 3, Nitto shall have
the right to immediately terminate this Agreement. If Nitto elects to
purchase the ownership interest of Quark in the Jointly Owned IP and
obtain the non-exclusive license under the Quark Licensed IP for
researching, developing, commercializing, and sale of Products in the
Field in the Territory, Nitto shall pay Quark [*] the amount applicable
under the provisions of section 7.2(iii)(a) above (if Stage 1 has been
completed but not Stage 2) or the provisions of section 7.2(iii)(b) above
(if Stage 2 has been completed). The bankruptcy or insolvency of Quark
after the completion of Stage 3 (or the bankruptcy or insolvency of Nitto
at any time) shall have no effect under this
Agreement.
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
11
(e) Consequences
of Termination without Cause under subsection (c )above if Nitto does not
purchase the Jointly Owned IP
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e.1
Any licenses and other rights granted by either Party to the other will
terminate and revert to the granting Party; and except as set forth in
this Section, the rights and obligations of the Parties hereunder shall
terminate as of the date of such termination.
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e.2
Nitto hereby grants Quark, effective as of the date of such termination, a
non-exclusive worldwide, royalty-bearing license, with the right to
sublicense, under any Nitto Background IP (if necessary to practice the
rights of this sub-Section) and agrees to assign to Quark Nitto’s interest
in the Jointly Owned IP, to develop, make, have made, use, sell, have
sold, offer for sale and import such Products as then being marketed or
developed by Nitto subject only to commercially reasonable royalty and
assignment price terms to be negotiated in good faith by the
Parties;
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e.3
Any license granted to Quark as described in the preceding subsection
(e.2) will include the right to use clinical and regulatory data and
information generated by Nitto for regulatory purposes relating to the
applicable Products; It will also include assignment to Quark of all of
its right, title and interest in and to all US and foreign regulatory
submissions and Regulatory Approvals with respect to the applicable
Products and all drug master files and drug dossiers with respect to the
applicable Products.
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(iv)
Termination In The Event
of Project Failure: The Parties recognize that pharmaceutical
product development is inherently uncertain and that there is no assurance
of success. In the event there is a material failure to achieve the
Project Goals at any stage of this Project, Nitto shall have the right to
terminate this Agreement as follows:
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(a)
Any licenses and other rights granted by either Party to the other will
terminate and revert to the granting Party; and the rights and obligations
of the Parties hereunder shall terminate as of the date of such
termination; and
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
12
(b)
Even after such termination, Quark’s obligation for the maintenance,
enforcement and handling litigation relating to the Jointly Owned IP shall
remain in effect, and Nitto and Quark shall share all expenses related to
intellectual property protection on an equal basis; and
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(c)
If Nitto elects to purchase the ownership interest of Quark in the Jointly
Owned IP and obtain the non-exclusive license under the Quark Licensed IP
for researching, developing, commercializing, and sale of Products in the
Field in the Territory, Nitto shall pay Quark [*] the amount applicable
under the provisions of section 7.2(iii)(a) above (if Stage 1 has been
completed but not Stage 2) or the provisions of section 7.2(iii)(b) above
(if Stage 2 has been completed), provided however that if and when Nitto
is able to [*] of [*] arising from the Project [*], then Nitto shall
notify Quark in writing and shall pay Quark [*].
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(v)
Consequences of
Termination. In the event of termination, the provisions of this
Agreement which by their terms would survive shall continue in effect, as
well as the rights and remedies of the Parties accruing prior to
termination.
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8. MISCELLANEOUS
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8.1 Governing
Law and Disputes
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The
laws of the State of New York, USA and Commercial Arbitration in
accordance with ICC rules. Such arbitration shall be conducted in the
English language and shall be held in New York, USA.
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8.2 Compliance
With Laws
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In
carrying out activities under this Agreement, each Party shall comply with
all applicable laws.
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8.3 Press
Release
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The
Parties will issue a mutually agreed form of press release regarding the
signing of the Agreement within 15 days from signature. In addition, in
the event that public announcement to stockholders or others relating to
this Agreement or the Project is required by any law or regulation, the
Party making any such announcement shall give the other Party an
opportunity to review in advance the manner or form of the
announcement.
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8.4 Confidentiality
|
The
Parties will keep confidential the terms of this Agreement, except as
required by law or by confidential due diligence by potential investors or
acquirors. Prior to the commencement of work under this Agreement, the
Parties shall execute a Confidentiality Agreement which shall provide for
the non-disclosure and non-use of data, information and materials
exchanged between the Parties, except for use and disclosure as reasonably
required to perform work or exercise rights under this Agreement. Such
obligation of confidentiality shall extend for the term of the Agreement
plus [*].
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
13
8.5 Relationship With Previous
Agreements
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This
Agreement will terminate and supersede the Prior Agreement, and the joint
Patent Application Agreement and the Memorandum of Understanding if
entered into prior to execution of this Agreement, provided, however, that
intellectual property created under such prior agreements shall continue
to be owned in accordance with the provisions of such agreements (subject
to the provisions related to Jointly Owned IP provided for in this
Agreement). The Non-Disclosure Agreements of the Parties dated [*] and [*]
shall remain in effect and shall apply to information exchanged pursuant
to this Agreement, until the Parties replace those agreements with a new
Confidentiality Agreement.
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8.6 No
Assignment
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Neither
this Agreement nor any of the one Party’s rights and obligations
thereunder shall be assignable without prior written consent of the other
Party.
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8.7 Tax
Matter
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The
Parties shall take all necessary measures to avoid double taxation on
payments to be made under this
Agreement.
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[Remainder
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
14
IN WITNESS WHEREOF, the
Parties hereto have caused this Agreement to be executed in duplicate, signed
and sealed by both Parties, and each original copy to be retained by each
Party.
Signed
for and behalf of:
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Signed for and behalf of: | |||||
Nitto
Denko Corporation
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Quark Pharmaceuticals, Inc. | |||||
By
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/s/ Kageshi
Maruyama
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By
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/s/ D.
Zurr
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Name:
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Kageshi
Maruyama
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Name:
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Xxxxxx
Xxxx
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|||
Officer,
General Manager of Corporate
|
Title:
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President &
CEO
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||||
Title:
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Business Development
Dept.
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|||||
Date:
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July 1st, 2010 |
in
Japan
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Date:
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July
4,
2010
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in
USA
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List
of Appendices and Exhibits:
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Appendix
A- Project Description (Tasks, Project Goals, Timelines and
Deliverables)
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Appendix
B- Budget
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Appendix
C- Initial Project Team
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Exhibit
1- Patents and Patent Applications Included Within Quark Licensed
IP
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[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
15
Appendix
A – Project Description (Tasks, Project Goals, Timelines and
Deliverables)
[*]
[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
Appendix
B – Budget
[*]
[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
Appendix
C
[*]
[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
EXHIBIT
1 Patents and Patent Applications Included Within Quark Licensed IP
Quark
Ref. No./
Pending
Patent
family
members
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Title
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Priority
Application(s)
No.
Priority
Filing date (s)
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International
Appl. No.
Application
Filing date
Publication
No.
Publication
filing date
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* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.