to Option and License Agreement
[
* ] = 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
10.37
Addendum
No 1
to
This
Addendum No. 1 (the “Addendum” is made and entered Into as of this 13th day of
July, 2007 (the “Effective Date”) between Silence Therapeutics AG, (formerly
known as Atugen AG) a company incorporated under the laws of Germany, whose
registered office is at ▇▇▇▇▇▇-▇▇▇▇▇▇-▇▇▇. ▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇
(hereinafter referred to as “ST”), and Quark
Pharmaceuticals, Inc. (formerly known as Quark Biotech, Inc.), a corporation
incorporated under the laws of California whose principal office is at ▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ and QBI Enterprises Ltd., a private company
incorporated under the laws of the State of Israel whose principal office is at
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇.▇. ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ (together
hereinafter referred to as “QBI”)
WHEREAS ST and QBI are parties
to an Option and License Agreement dated April 19, 2005 (the “Agreement”);
WHEREAS the Parties are
desirous to make certain additions and amendments to the Agreement as set forth
more fully below, to reflect their agreement to add additional QBI Targets to
the Agreement:
NOW, THEREFORE the Parties
hereto agree as follows:
|
1.
|
Scope:
|
|
|
1.1
|
The
terms of the Agreement as amended in this Addendum shall apply only to the
Additional QBI
Products (as defined below).
|
|
|
1.2
|
The
terms of the Agreement (and not of this Addendum) shall continue to apply
to the License granted to QBI under the agreement in relation to the [*]
target and with respect to the additional target that QBI still has the
right to select for an Option and License under the terms and conditions
of Agreement (the “Original Target”),
except that the selection mechanism described in section 3.2 below will
apply in relation to the Original
Target.
|
|
|
1.3
|
The
Parties hereby confirm that the Option Period according to Section 3.3 of
the Agreement [*].
|
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2.
|
Definitions:
|
|
|
2.1
|
In
this Addendum, save as otherwise provided herein, all terms defined in the
Agreement when used herein shall have their defined meanings as specified
in the Agreement.
|
|
|
2.2
|
“Atugen IP” means Atugen
IP as defined in the Agreement [*] Patent application [*] describing the
[*] and [*] and all equivalent and derived applications including
[*].
|
|
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2.3
|
“AtuRNAi(s)” (formerly known as
“atuRNAi(s)”) shall mean siRNAs inhibiting Additional QBI Targets
(as defined in section 3.1 of this Amendment below) for therapeutic
intervention, [*] which would infringe a Valid Patent Claim of the Atugen
IP were it not for the grant of the options and licenses set forth in this
Addendum.
|
|
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2.4
|
“Additional QBI Product”
shall mean an AtuRNAi (as defined above), commercialized by QBI or its
sublicensee for human diagnostic or therapeutic
use.
|
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2.5
|
“Target” shall mean Homo
sapiens “NAME” (abbreviation) mRNA encoded by the XXX gene as more
specifically described in Appendix I, and splice variants thereof.
The term target shall include, and the license will allow, using non-human
orthologs for preclinical studies that will enable to obtain proof of
concept and approval of an IND for clinical trials. Target could
also be a mRNA and protein expression product of a pathogenic
organism.
|
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3.
|
Grant of Additional
QBI Options:
|
|
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3.1
|
QBI
shall be entitled to select up to three (3) additional Targets (the “Additional QBI Targets”)
in accordance with section 3.2 of this Amendment below in order to obtain
from ST an option for a non-exclusive and worldwide License for the Atugen
IP with the right to sub-license in accordance with the terms of the
Agreement and this Addendum, to develop and commercialize Additional QBI
Products (the “Additional
QBI Option(s)”). The right of QBI to select up to three
Additional QBI Targets in order to obtain up to three Additional QBI
Options for these selected targets shall [*]. It is understood by
the Parties that each such Additional QBI Option will be separately
granted by ST for each Additional QBI
Target.
|
|
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3.2
|
Selection
of an Additional QBI Target for the Additional QBI Option. QBI shall
have the right to select an Additional QBI Target in order to obtain an
Additional QBI Option as set forth in this Section
3.2:
|
3.2.1
QBI shall provide ST with the QBI Option Notice for the selected
Additional QBI Target for which it requests an option. This QBI Option
Notice has to be sent by mail and by email to the Chief Executive Officer of ST
on or before [*].
3.2.2
ST shall have [*] to [*] Additional QBI Target. Within such time,
ST will provide QBI with a [*], where relevant, the [*] (as defined
below). There are [*] in which [*] a particular Target:
|
|
1.
|
If
[*] or [*] (e,g., [*]) and such [*] and [*] by [*] a [*] of the [*].
For the purposes of this Addendum a [*] is a [*] of an [*] of [*] and [*],
which will [*] by [*], [*] which are [*] under the [*] to [*] or [*] (the
“[*]”).
|
[
* ] = 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.
|
|
2.
|
If
[*] with respect to [*] that [*].
|
|
|
3.
|
If
[*] is the [*] with [*] within the [*] that [*] and such [*] and the [*]
has [*] by [*] of the [*]. In the event that a [*] or a [*] with the
[*] for [*] has [*] within [*] it [*] of [*], [*] and [*] for
[*].
|
|
|
3.2.3
|
[*]
that particular Target included in the QBI Option Notice is automatically
added to the list of Additional QBI Targets for which QBI has an
Additional QBI Option until three (3) Additional QBI Targets are on the
list of selected Targets. For clarity, if [*] as set forth in [*]
and [*], in such case QBI shall be [*] that [*] or
[*].
|
|
|
3.3
|
Option
Periods: Each of the three Additional QBI Options will be
granted to QBI for a period of [*] starting with the delivery of a QBI
Option Notice by QBI to ST (the “Amended Option Period”),
and shall automatically expire thereafter unless QBI has exercised the
Additional QBI Options by delivery to ST of written notice thereof.
For clarity, the Option Fee of €[*] according to Section 3.7.2 of the
Agreement shall be payable within [*] after the delivery of each QBI
Option Notice for each Additional QBI Option (provided
[*]).
|
|
|
3.4
|
Exercise of the
Additional QBI Options: QBI can exercise each of the
Additional QBI Options granted hereunder after the delivery of the QBI
Option Notice to ST at any time during the applicable Amended Option
Period by written notice to ST (the “Exercise Notice”).
The exercise of the Additional QBI Option is contingent upon payment of
the exercise fee of € [*] (Euro [*]) in accordance with section 3.8 of the
Agreement payable within [*] from the delivery of the respective
Additional Option Exercise Notice.
|
|
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3.5
|
License
Grant: Upon exercise of each specific Additional QBI Option
in accordance with section 3.4 above, QBI will have a non-exclusive and
worldwide license with the right to sub-license under the Atugen IP and
the know-how relating to the AtuRNAi(s) to research, develop, have
developed, manufacture, have manufactured, market and sell Licensed QBI
Products.
|
|
|
3.6
|
Milestone Payments and
Royalties: Sections 4.3, 4.4 and 4.5 of the Agreement will be
amended with respect only to the Additional QBI Products as
follows:
|
|
|
3.6.1
|
In
Section 4.3.1.1 of the Agreement the figure €[*] will be replaced by € [*]
(Euro [*]);
|
|
|
3.6.2
|
In
both Sections 4.3.1.2 and 4.3.1.3 of the Agreement the figure €[*] will
each be replaced by € [*] (Euro [*]), such payment each of €[*] (€[*] in
accordance with Section 4.3.2 of the Agreement and as restated in section,
3.6.7 of this Amendment) shall be
[*].
|
|
|
3.6.3
|
The
second paragraph of Section 4.3.3 of the Agreement shall be
deleted.
|
[
* ] = 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.
|
|
3.6.4
|
In
Section 4.4.1 of the Agreement the figure [*]% will be replaced by [*]%;
the figure [*]% will be replaced by [*]%; and the figure [*]% will be
replaced by [*]%.
|
|
|
3.6.5
|
Section
4.4.3 of the Agreement shall be deleted in its entirety and replaced by
the following provision:
|
In the
event that QBI develops an Additional QBI Product that is [*] and if QBI or its
Sublicensee (i) reasonably determines that, in order to avoid infringement of
any patent not licensed hereunder, it is necessary for QBI to obtain a license
from a third party, in a country in the Territory and to pay a royalty or other
payment under such license (including in connection with settlement of a patent
infringement claim), or (ii) shall be subject to a final court or other binding
order or ruling requiring the payment of a royalty or other payment to a third
party patent holder (“Third
Party Patent Licenses”), [*] of any royalties paid under Third Party
Patent Licenses by QBI or its Affiliates shall be creditable against royalties
payable to ST hereunder, provided, however, that in no event shall such credit
cause the royalties payable to ST for any particular year to be reduced to less
than [*] of the amount that would otherwise be payable to ST for such
year. In the event of a dispute between QBI and ST on the question whether
such Additional QBI Product infringes a patent as above, such dispute will be
resolved by a mutually acceptable patent attorney, and failing agreement on such
patent attorney, by arbitration in accordance with section 8 of the
Agreement.
In the
event that QBI develops an Additional QBI Product that is [*], then (i) the
royalty stacking provision mentioned in the previous paragraph above of this
section 3.6.5 of the Amendment and also any other royalty stacking provision
shall [*]; (ii) QBI may enter into a Third Party Patent License [*] that
requires such Third Party License as [*] of a [*] AtuRNAi or an Additional QBI
Product including a [*] AtuRNAi. In such event any royalties paid to such
third party shall [*].
|
|
3.6.6
|
In
sections 4.5.1 and 4.5.2 of the Agreement, the figure [*]% will be
replaced by [*]%; and the figure [*]% will be replaced by
[*]%.
|
|
|
3.6.7
|
ST
declares and QBI acknowledges that [*] and that consequently the
conditions of Sections [*] of the Agreement have been fulfilled with the
consequences that (a) the [*] in Section [*] of the Agreement, (b) the [*]
in Section [*] of the Agreement and (c) the [*] in Section [*] of the
Agreement as well as [*] in accordance with section [*] and [*] in
accordance with section [*] of this Amendment shall
[*].
|
|
4.
|
For
any Additional QBI Target, Sections 2.1 through 2.3, 2.7 though 2.11 and
Section 5.2 of the Agreement shall not apply. For clarity, Sections
2.4 through 2.6 and Section 5.1 will also apply for any Additional QBI
Target. QBI may exercise each such Additional QBI Option for all
therapeutic fields including
oncology.
|
[
* ] = 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.
|
5.
|
Public
Announcements. QBI and ST agree that they will jointly
publicly announce the execution of this Addendum. The joint press
release is set forth in Appendix II attached hereto and may be promptly
disseminated following the execution of this Addendum by any party,
provided it is approved by QBI’s securities counsel prior to publication;
such approval shall not unreasonably be withheld. ST and QBI will
communicate on the pipeline page of their respective websites and in the
corresponding public announcements for each Option Notice and Exercise
Notice and the following announcements for the in-licensed AtuRNAi
compounds that the siRNA compounds developed under the agreements with ST
have an AtuRNAi structure in-licensed from ST. QBI undertakes the
additional obligation to communicate to ST about the [*] with siRNA
compounds which have an AtuRNAi structure within [*] of the [*] and if the
[*], within [*] after such [*]. Except for the joint press release
set forth in this section 5, no party may make a public statement or
disclosure (written or oral), including in analyst meetings, relating to
confidential information of this Agreement or its subject matter, without
the prior express written permission of the other Party, except where such
statement: (a) is required by applicable law or legal proceedings, or (b)
in the case of any public statement or disclosure pursuant to clause (a)
above, the party required to make such statement or disclosure shall (i)
use reasonable efforts to include in such statement or disclosure only the
information that, after consultation with counsel, such party believes is
required by applicable law to be disclosed and (ii) provide the other
party with a copy of such statement sufficiently in advance of
dissemination so that the other party will have the opportunity to comment
upon the statement, and shall give due consideration to any comments of
the other party in the final
statement.
|
|
6.
|
[*]. In
the event of [*] (as defined below), QBI’s right hereunder to receive an
option and a License with respect to Target which [*]. For the
avoidance of doubt, QBI’s rights hereunder with respect to Additional QBI
Targets that [*] in accordance with Section
[*].
|
For the
purposes of this Section - “[*]” shall mean any [*] or [*] which,
[*].
|
In
Witness Whereof –
|
||||||
|
QBI
|
ST
|
|||||
|
Quark
Pharmaceuticals, Inc.
|
Silence
Therapeutics AG
|
|||||
|
QBI
Enterprise Ltd.
|
||||||
|
By:
|
/s/ D. Zurr
|
By:
|
/s/ ▇▇▇▇▇▇ Christély
|
|||
|
Name:
▇▇▇▇▇▇ ▇▇▇▇
|
Name:
▇▇▇▇▇▇ Christély ▇▇. ▇▇▇▇▇
▇▇▇▇▇
|
|||||
|
Title:
President and CEO
|
Title:
CEO
CSO
|
|||||
|
Date
|
July 30, 2007
|
Date:
|
July 30,
2007
|
|||
[
* ] = 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.
Appendix
I
Target
NAME
RefSeqN/NM
XXXXX (number defines the Target) Nucleotide sequence of the mRNA including 5’
and 3’ untranslated regions or such identification of the target in EMBL
nucleotide databases or similar information that uniquely identifies the target
gene if not submitted to RefSeqN or EMBL)
[
* ] = 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.
Appendix
II
Silence
Therapeutics And Quark Pharmaceuticals Expand Strategic Licensing
Agreement.
London,
England and Fremont, CA, 30th, July 2007
Silence
Therapeutics plc and Quark Pharmaceuticals, Inc. (“Quark”), announced today an
expansion of their current strategic technology licensing
agreement.
In April
2005 the Companies signed an Option and Licence Agreement, which provided Quark
with access to Silence Therapeutics’ novel proprietary siRNA technology,
AtuRNAi. The first outcome of Companies’ relationship was the development
of the AtuRNAi technology-based compound RTP801i, which was licensed to Pfizer
Inc in 2006 by Quark and is currently in a phase 1 clinical trial in patients
with wet age related macular degeneration. Quark’s product portfolio
includes one additional siRNA molecule with a structure covered by patents
licensed from Silence Therapeutics.
The
expanded agreement provides Quark with options to non-exclusive licenses to
develop additional molecules against 3 specific targets using Silence
Therapeutics’ proprietary AtuRNAi technology. The terms of the amendment
signed today will entitle Silence Therapeutics to milestone payments and a
royalty on product sales after exercise of the options by Quark. Further
financial details were not disclosed,
▇▇▇▇▇
▇▇▇▇, Chief Executive Officer of Quark Pharmaceuticals: “We are pleased to
extend our relationship with Silence Therapeutics. We believe extending
this relationship provides Quark with opportunities to further develop its
pipeline of clinical product candidates targeted at indications with significant
unmet medical needs.”
▇▇▇▇
▇▇▇▇, Chairman of Silence Therapeutics stated: “This is a long-standing
relationship for us and we are pleased we have been able to broaden it.
The goal in the RNAi sector is to advance clinical development and Quark has
already proven it can utilise our proprietary AtuRNAi technology and take
products into the clinic. This agreement forms part of our continuing
strategy of signing target-specific collaboration and license agreements with
pharmaceutical and biotech companies which will lead to a broader clinical
application of our AtuRNAi product platform outside of our internal programs for
systemic applications in oncology.”
- Ends
-
[
* ] = 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.
Notes
to Editors
Quark Pharmaceuticals is a
clinical-stage biopharmaceutical company focused on discovering and developing
novel therapeutics based on its proprietary gene discovery science and
technology, with an initial focus on drug candidates that work through the
natural mechanism in the cell known as RNA interference, or RNAi, for the
treatment of diseases associated with oxidative stress. Quark believes
that its proprietary target gene discovery platform, BIFARTM,
combined with its ability to design and successfully deliver synthetic molecules
of the new class of RNAi therapeutics known as small-interfering RNA, or siRNA,
to specific organs in the body, enables the Company to rapidly develop drug
candidates. Quark has two internally discovered and developed lead product
candidates: RTP801i-14 in phase 1 clinical trial for the treatment of wet
age-related macular degeneration, and AKIi-5 for the prevention of acute renal
failure. The Company has licensed RTP801i-14 to Pfizer on an exclusive
worldwide basis. Quark corporate product development teams are based in
Fremont, CA and research facilities in Ness-Ziona, Israel. Additional
information is available at ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇
Notes
to Editors
Silence Therapeutics plc
(▇▇▇.▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇)
Silence
Therapeutics plc (LSE:SLN) is a leading RNAi company. RNA interference
(RNAi) can selectively ‘silence’ genes linked to the onset of
disease.
Silence
Therapeutics has developed novel, proprietary short interfering RNA (‘siRNA’)
molecules, AtuRNAi, which provide a number of advantages over conventional siRNA
molecules as they show increased stability against nuclease degradation.
In addition, the Company has developed a proprietary systemic delivery system,
AtuPLEX. This enables the delivery of siRNA molecules to targeted diseased
tissues and cells, whilst increasing their bioavailability and intracellular
uptake.
In July
2007, Silence Therapeutics formed a research and development collaboration with
Astra Zeneca to develop AtuRNAi against five targets in respiratory
indications. The Group’s AtuRNAi technology has also been sublicensed to
Pfizer by Quark Pharmaceuticals, through Quark’s license of the compound
RTP-801i-14 for the treatment of Age-related Macular Degeneration (AMD) and a
number of other indications. This compound entered the clinic in early
2007. Quark Pharmaceuticals, Inc. has developed a further compound,
AKIi-5, having AtuRNAi structure under the existing licence from Silence
Therapeutics. This compound has been granted an IND for acute kidney
injury and is expected to enter the clinic in 2007. In addition, Silence
Therapeutics expects to begin the clinical development of its proprietary
AtuRNAi therapeutic molecules for systemic cancer indications, such as
gastrointestinal and non-small lung cancer, in 2008.
Silence
Therapeutics is based in London, UK, and Berlin, Germany, and is listed on
AIM.
[
* ] = 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.
About
RNAi
RNA
interference (RNAi), a Nobel Prize winning technology, is one of the most
exciting areas of drug discovery today. It represents a completely new approach
to selectively ‘silence’ or inactivate disease relevant genes and as such it has
the potential to create a new class of therapeutic products. RNAi could
therefore offer a therapeutic approach to a broad range of diseases (cancer,
infectious diseases, inherited diseases), many of which have been regarded as
incurable and are not addressed by current therapeutics, therefore providing a
large market opportunity.
Forward-Looking
Statements
This
press release includes forward-looking, statements that are subject to risks,
uncertainties and other factors. These risks and uncertainties could
cause actual results to differ materially from those referred to in the
forward-looking statements. All forward-looking statements are based
on information currently available to Silence Therapeutics and Silence
Therapeutics assumes no obligation to update any such forward-looking
statements.
Enquiries:
For
further information, please contact the following:
|
Silence
Therapeutics plc
▇▇▇(▇)▇▇
▇▇▇▇ ▇▇▇▇
▇▇▇▇
▇▇▇▇, Chairman
▇▇▇▇▇▇
▇▇▇▇▇▇, Finance Director
|
Quark
Pharmaceuticals, Inc.
▇▇-▇▇▇-▇▇▇-▇▇▇▇
▇▇▇▇
▇▇▇▇▇▇▇▇, Chief Operating Officer
|
|
▇▇▇(▇)
▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇
Christély, Chief Operating Officer
▇▇.
▇▇▇▇▇ ▇▇▇▇▇, Chief Scientific Officer
|
|
|
Investor
Relations
Citigate
Dewe ▇▇▇▇▇▇▇▇
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Investor
Relations
The
▇▇▇▇ Group
▇▇-▇▇▇-▇▇▇-▇▇▇▇
/ 7025
▇▇▇▇▇▇
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Nominated
Advisers
▇▇▇▇▇
▇▇▇▇▇▇▇▇ Corporate Finance
▇▇▇(▇)▇▇
▇▇▇▇ ▇▇▇▇
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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.