Option Agreement By And Between Novartis International Pharmaceutical Limited And Quark Pharmaceuticals, Inc.
Execution
Copy
CONFIDENTIAL
Β
Β [ * ] = 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.
Β
Exhibit
10.35
Β
Β
Β
By
And Between
Β
Novartis
International Pharmaceutical Limited
Β
And
Β
Quark
Pharmaceuticals, Inc.
Β
Β
Β
1.
|
DEFINITIONS
AND INTERPRETATION
|
2
|
Β | Β | Β |
2.
|
OPTION
GRANT
|
9
|
Β | Β | Β |
3.
|
GOVERNANCE
AND DEVELOPMENT DURING OPTION PERIOD
|
9
|
Β | Β | Β |
4.
|
EXERCISE
OF OPTION AND GRANT OF LICENSE
|
15
|
Β | Β | Β |
5.
|
CONFIDENTIALITY
|
19
|
Β | Β | Β |
6.
|
INTELLECTUAL
PROPERTY
|
20
|
Β | Β | Β |
7.
|
TERM
AND TERMINATION
|
22
|
Β | Β | Β |
8.
|
REPRESENTATIONS,
WARRANTIES, COVENANTS AND INDEMNITIES
|
23
|
Β | Β | Β |
9.
|
PUBLICATIONS
AND PUBLICITY
|
27
|
Β | Β | Β |
10.
|
GENERAL
PROVISIONS
|
28
|
Β
[ * ] = 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.
Β
Β
Β
Β
This
OPTION AGREEMENT (βOption
Agreementβ) is made as of this 17th day of
August, 2010 (βOption Agreement
Effective Dateβ), by and between Novartis International Pharmaceutical
Limited, located at 000 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxx, a corporation organized
and existing under the laws of Bermuda (βNovartisβ) and Quark
Pharmaceuticals, Inc., located at 0000 Xxxxxxxxx Xxxxxx, Xxxxxxx, XX 00000,
U.S.A., a corporation organized and existing under the laws of California,
U.S.A. (βQuarkβ).Β Β Novartis
and Quark are each referred to individually as a βPartyβ and together as the
βParties.β
Β
RECITALS
Β
WHEREAS,
Quark owns or controls the Quark Patents and Quark Know-How (each as defined
below) relating to the Quark Compounds (as defined below);
Β
WHEREAS,
Novartis wishes to obtain, and Quark wishes to grant to Novartis, an exclusive
option to obtain exclusive rights to the Quark Compounds in the Field (as
defined below).
Β
NOW,
THEREFORE, in consideration of the mutual covenants and agreements herein
contained, the Parties agree as follows.
Β
1.
|
DEFINITIONS
AND INTERPRETATION
|
Β
1.1
|
Definitions.Β Β Unless
the context otherwise requires, the terms in this Option Agreement with
initial letters capitalized, shall have the meanings set forth below, or
the meaning as designated in the indicated places throughout this Option
Agreement.
|
Β
βAffiliateβ has the meaning
set forth on Exhibit
A.
Β
Β βAKI Final Reportβ means
the complete, signed, detailed, data cleaned, statistically analyzed, unbiased,
unblinded, unblended and cGCP audited and compliant final report(s) of the AKI
Phase II Trial setting forth patient outcomes for [*] following dosing based on
a fully monitored, cleaned, QA/QC assessed and locked database, the format and
content of which shall be in accordance with the ICH E3 Guidelines, and which
shall include all available raw data in a user-friendly electronic format, as
well as primary and secondary efficacy endpoint data, all material efficacy,
safety, clinical and medical data, and any other information related
thereto.
Β
βAKI First Interpretable
Resultsβ means an interim report of the AKI Phase II Trial setting forth
patient outcomes for [*] following dosing based on cleaned, unbiased, unblinded
data, the format and content of which shall be in accordance with the template
attached as Exhibit
J, and which shall include all available raw data in a user-friendly
electronic format on a fully monitored, cleaned QA/QC assessed and locked
database, as well as primary and secondary efficacy endpoint data, all material
efficacy, safety, clinical and medical data, and any other information related
thereto.
Β
[ * ] = 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.
Β
2
Β
Β
βAKI Indicationβ has the
meaning set forth on Exhibit
A.
Β
βAKI Phase II Trialβ means the
Phase II Clinical Trial for use of a Product for the AKI Indication to be
conducted by Quark in accordance with the AKI Phase II Trial
Protocol.
Β
βAKI Phase II Trial Protocolβ
means the draft protocol for the AKI Phase II Trial attached as Exhibit C, as such
protocol may be amended by Quark from time to time prior to the Option Exercise
Date.
Β
βAKI Phase II Trial [*]
Criteriaβ means the [*] criteria for the AKI Phase II Trial set forth on
Exhibit
D.
Β
βBusiness Dayβ has the meaning
set forth on Exhibit
A.
Β
βCalendar Quarterβ has the
meaning set forth on Exhibit
A.
Β
βCalendar Yearβ has the meaning
set forth on Exhibit
A.
Β
βcGCPβ means current good
clinical practice as required by the FDA and all applicable FDA rules,
regulations, orders and guidances, and the requirements with respect to current
good clinical practices prescribed by the European Community and the
ICH.
Β
βcGLPβ means current good
laboratory practice as required by the FDA and all applicable FDA rules,
regulations, orders and guidances, and the requirements with respect to current
good clinical practices prescribed by the European Community and the
ICH.
Β
βcGMPβ means current good
manufacturing practices as required by the FDA under provisions of 21 C.F.R.
parts 210 and 211 (as the same may be amended) and all applicable FDA rules,
regulations, orders and guidances, and the requirements with respect to current
good manufacturing practices prescribed by the European Community under
provisions of βThe Rules Governing Medicinal Products in the European Community,
Volume 4, Good Manufacturing Practices, Annex 13, Manufacture of investigational
medicinal products, July 2003,β as each may, from time to time, be amended, and
the ICH.
Β
βClaimsβ means all Third Party
demands, claims, actions, proceedings and liability (whether criminal or civil,
in contract, tort or otherwise) for losses, damages, reasonable legal costs and
other reasonable expenses of any nature whatsoever.
Β
βCommercializeβ and βCommercializationβ have the
meaning set forth on Exhibit
A.
Β
[ * ] = 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.
Β
3
Β
Β
βCommercially Reasonable
Effortsβ means the expenditure of those efforts and resources used [*] in
pursuing development or commercialization of [*], or where [*] does not [*], the
expenditure of such efforts and use of such resources [*].Β Β For
clarity, βCommercially Reasonable Effortsβ shall be [*], accordingly, [*] with
respect to [*] may [*] with respect to [*].
Β
βConfidential Informationβ
means all Know-How and other proprietary information and data of a financial,
commercial or technical nature which the disclosing Party or any of its
Affiliates has supplied or otherwise made available to the other Party or its
Affiliates, whether made available orally, in writing or in electronic form,
including information comprising or relating to concepts, discoveries,
inventions, data, designs or formulae in relation to this Option
Agreement.
Β
βDamaged Partyβ has the
meaning set forth in Section 8.6.
Β
βDevelopβ and βDevelopmentβ have the meaning
set forth on Exhibit
A.
Β
βDevelopment Costsβ means
expenses incurred by Quark in carrying out the remaining work under the Quark
Development Plan, as agreed by the Parties in accordance with Section 3.2(e),
calculated as the sum of the following:
Β
Β
|
(a)
|
all
[*] incurred by Quark with respect to the activities outlined in the Quark
Development Plan, [*]; and
|
Β
Β
|
(b)
|
the
[*] in carrying out the activities outlined in the Quark Development Plan
[*].
|
Β
βDevelopment Cost Budgetβ has
the meaning set forth in Section 3.2(e).
Β
βDGF DMC Top Line Interim
Reportβ means an interim report(s) of DGF Phase II Trial (after each
interim analysis) setting forth patient outcomes for [*] following dosing based
on a partially monitored and source-verified data, provided however that all
data fields relating to the analysis of the efficacy success criteria are
[*].Β Β All other data fields will be consistent with industry practices
for interim review in an on-going blinded trial.Β Β All data will be
collected in a 21 C.F.R. 11 validated database with full audit
trail.Β Β All the DMC recommendations [*] as based on their review of
un-blinded data, will be provided verbatim to Quark and
Novartis.Β Β Interim blinded data will also be provided in a
user-friendly electronic format to Novartis.Β Β Such blinded data shall
include all material efficacy, safety, clinical and medical data, and any other
information related thereto, including data relating to patient and graft
survival.Β Β Serious Adverse Event (SAE) listings and adverse events
(AE) listings are based on the unlocked database.
Β
βDGF Final Reportβ means the
complete, signed, detailed, data cleaned, statistically analyzed, unbiased,
unblinded, unblended and cGCP audited and compliant final report(s) of the DGF
Phase II Trial setting forth patient outcomes for [*] following dosing based on
a fully monitored, cleaned, QA/QC assessed and locked database, the format and
content of which shall be in accordance with the ICH E3 Guidelines, and which
shall include all available raw data in a user-friendly electronic format, as
well as primary and secondary efficacy endpoint data, all material efficacy,
safety, clinical and medical data, and any other information related
thereto.
Β
[ * ] = 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.
Β
4
Β
Β
βDGF Indicationβ has the
meaning set forth on Exhibit
A.
Β
βDGF Phase II Trialβ means the
Phase II Clinical Trial for use of a Product for the DGF Indication to be
conducted by Quark in accordance with the DGF Phase II Trial
Protocol.
Β
βDGF Phase II Trial Protocolβ
means the protocol for the DGF Phase II Trial attached as Exhibit E, as such
protocol may be amended by Quark from time to time.
Β
βDGF Phase II Trial [*]
Criteriaβ means the [*] criteria for the DGF Phase II Trial set forth on
Exhibit
F.
Β
βDGF [*] Reportβ means the
complete, signed, detailed, data cleaned, statistically analyzed, unbiased,
unblinded and cGCP audited and compliant interim report(s) of the DGF Phase II
Trial setting forth patient outcomes for [*] following dosing based on a fully
monitored, cleaned, QA/QC assessed and locked database, the format and content
of which shall be in accordance with the ICH E3 Guidelines, and which shall
include all available raw data in a user-friendly electronic format, as well as
primary and secondary efficacy endpoint data, all efficacy, safety, clinical and
medical data, and any other information related thereto, including all available
top line data relating to patient and graft survival, Serious Adverse Event
(SAE) listings (including biopsy proven acute rejections) and adverse events
(AE) listings based on the unlocked database for the period beyond the [*]
locked data.
Β
βDMCβ means the Independent
Data Monitoring Committee, consisting of external experts to the applicable
Phase II Clinical Trial, to assess the progress, safety data and endpoint
adjudication following a harmonized and standardized endpoint assessment and to
perform pre-defined, semi-blended interim analyses.
Β
βDraft Phase II Trial Reportβ
has the meaning set forth in Section 3.5(a).
Β
βExpiration Dateβ has the
meaning set forth in Section 4.1(b)(v).
Β
βFieldβ has the meaning set
forth in Exhibit
A.
Β
βFTE Rateβ means a rate of [*]
US Dollars ($[*]) per Calendar Year based on the yearly time of an employee for
a full-time equivalent scientific person year (consisting of a total of [*]
hours per Calendar Year) of work, to be pro-rated on a daily basis if necessary
(per Calendar Year amount to be divided by [*] to produce the rate per whole day
consisting of eight (8) hours); such rate to [*] and [*]. For the avoidance of
doubt, such rate includes [*] for which [*].Β Β The FTE Rate shall be
[*] to [*] in the [*] from the Option Agreement Effective Date.
Β
[ * ] = 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.
Β
5
Β
Β
βHSR Actβ means the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules
promulgated thereunder.
Β
βHSR Filing Dateβ shall have
the meaning set forth in Section 4.2.
Β
βInsolvency Eventβ has the
meaning set forth in Exhibit
A.
Β
βJoint Development Technologyβ
means all Know-How and Patent Rights created, conceived, reduced to practice or
invented jointly by (a) Quark, its Affiliates, agents or Third Parties acting on
its behalf and (b) Novartis, its Affiliates, agents or Third Parties acting on
its behalf, under this Option Agreement.
Β
βJoint Discussion
CommitteeβΒ or βJDCβ means the committee
established as set forth inΒ Section
3.1.
Β
βKnow-Howβ has the meaning set
forth on Exhibit
A.
Β
βLicenseβ has the meaning set
forth in Section 4.1(c).
Β
βLicense Effective Dateβ means
the later of (i) the Option Exercise Date or (ii) the date on which the waiting
period provided by the HSR Act shall have terminated or expired without any
action by any government agency or challenge to the License (or any other
timeline required by another relevant agency or authority).
Β
βNovartis Development
Technologyβ means all Know-How and Patent Rights (if any) created,
conceived, reduced to practice or invented solely by Novartis, its Affiliates,
agents or by Third Parties acting on its behalf, in connection with the Quark
Program during the term of this Option Agreement.
Β
βNovartis Success Criteria
Noticeβ has the meaning set forth in Section 4.1(a)(i)
Β
βOptionβ has the meaning set
forth in Section 2.1.
Β
βOption Agreement Effective
Dateβ shall have the meaning set forth in the first paragraph of this
Option Agreement.
Β
βOption Exercise Dateβ means
the date (if any) on which Novartis exercises the Option in accordance with
Section 4.1(a) (or Section 3.4(b), if applicable).
Β
βOption Grant Feeβ has the
meaning set forth in Section 2.2.
Β
βOption Periodβ means the
period of time commencing on the Option Agreement Effective Date and ending on
the earlier of (a) the Option Exercise Date; (b) the date on which the Option
expires in its entirety pursuant to Section 4.1(b).
Β
βOut-of-Pocket Costβ means
direct project related expenses paid or payable to Third Parties and
specifically identifiable and incurred in accordance with the Quark Development
Plan; such expenses shall have been recorded [*] in accordance with Quarkβs
Accounting Standards and for the avoidance of doubt, [*].
Β
[ * ] = 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.
Β
6
Β
Β
βPatent Rightsβ has the
meaning set forth in Exhibit
A.
Β
βPersonβΒ means any individual,
partnership, limited liability company, firm, corporation, association, trust,
unincorporated organization or other entity.
Β
Β βPhase II Clinical
Trialβ has the meaning set forth in Exhibit
A.
Β
βPhase II Trial Reportsβ
means, collectively, the DGF DMC Top Line Interim Report, the DGF [*] Report,
the DGF Final Report, the AKI First Interpretable Results, and the AKI Final
Report.
Β
βProductβ has the meaning set
forth in Exhibit
A.
Β
βQuark Compoundsβ has the
meaning set forth in Exhibit
A.Β Β
Β
βQuark Development Planβ means
Quarkβs plan for the development of the Products through to completion of the
AKI Phase II Trial and the DGF Phase II Trial, as set forth on Exhibit G, as such
development plan may be amended by Quark from time to time prior to the Option
Exercise Date.
Β
βQuark Development Technologyβ
means all Know-How and Patent Rights created, conceived, reduced to practice or
invented solely by Quark, its Affiliates, agents or by Third Parties acting on
its behalf, in connection with the Quark Program during the term of this Option
Agreement.
Β
βQuark Know-Howβ has the
meaning set forth in Exhibit
A.
Β
βQuark Notice of [*]β has the
meaning set forth in Section [*]
Β
βQuark Patentsβ has the
meaning set forth in Exhibit
A.Β Β
Β
βQuark Programβ means Quarkβs
program relating to the research and development of the Quark Compounds and the
Products, including the AKI Phase II Trial and the DGF Phase II
Trial.
Β
βQuark Program Confidential
Informationβ means information and data relating to the Quark Compounds,
Product and/or Quark Program and the Quark Know-How, Quark Patents (to the
extent not published) and other non-public Quark Technology, in each case, to
the extent that such information and data is of a type and character which is,
consistent with industry practice, kept confidential.
Β
βQuark Technologyβ has the
meaning set forth in Exhibit A, and shall
include, for the avoidance of doubt, all Quark Development
Technology.
Β
[ * ] = 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.
Β
7
Β
Β
βRegulatory Authorityβ has the
meaning set forth in Exhibit
A.
Β
βRegulatory Filingsβ has the
meaning set forth in Exhibit
A.
Β
βSection 8.1(a) Decision Periodβ
has the meaning set forth in Section 4.1(a)(i).
Β
βSenior Officersβ means, for
Novartis, the Head of Development (for Development matters) and Head of Business
Development and Licensing (for all other matters) of Novartis Pharma AG, and for
Quark, the Chief Executive Officer (for all matters).
Β
βTerritoryβ has the meaning
ascribed to such term in Exhibit
A.
Β
βThird Partyβ means any Person
other than a Party or an Affiliate of a Party.
Β
βUnited StatesβΒ or βUSβ means the United States of
America, its territories and possessions.
Β
βUSDβ or βUS$β means the lawful
currency of the United States.
Β
1.2
|
Interpretation.Β Β In
this Option Agreement unless otherwise
specified:
|
Β
Β
|
(a)
|
βincludesβ
and βincludingβ shall mean respectively includes and including without
limitation;
|
Β
Β
|
(b)
|
a
statute or statutory instrument or any of their provisions is to be
construed as a reference to that statute or statutory instrument or such
provision as the same may have been or may from time to time hereafter be
amended or re-enacted;
|
Β
Β
|
(c)
|
words
denoting the singular shall include the plural and vice versa and words
denoting any gender shall include all
genders;
|
Β
Β
|
(d)
|
the
Exhibits and other attachments form part of the operative provision of
this Option Agreement and references to this Option Agreement shall,
unless the context otherwise requires, include references to the Exhibits
and attachments;
|
Β
Β
|
(e)
|
the
headings in this Option Agreement are for information only and shall not
be considered in the interpretation of this Option
Agreement;
|
Β
Β
|
(f)
|
general
words shall not be given a restrictive interpretation by reason of their
being preceded or followed by words indicating a particular class of acts,
matters or things; and
|
Β
Β
|
(g)
|
the
Parties agree that the terms and conditions of this Option Agreement are
the result of negotiations between the Parties and that this Option
Agreement shall not be construed in favor of or against any Party by
reason of the extent to which any Party participated in the preparation of
this Option Agreement.
|
Β
[ * ] = 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.
Β
8
Β
Β
2.
|
OPTION
GRANT
|
Β
2.1
|
Option Grant. Subject to
the terms and conditions of this Option Agreement, Quark hereby grants to
Novartis an exclusive option to obtain the License (βOptionβ). Novartis may
exercise its rights and perform its obligations under this Option
Agreement itself or through any of its Affiliates; provided that
Novartis shall remain primarily liable for any acts or omissions of its
Affiliates under this Option Agreement or the License
Agreement.
|
Β
2.2
|
Option Grant
Fee.Β Β In consideration of the Option granted to Novartis
hereunder, Novartis shall pay to Quark a one-time, non-refundable,
non-creditable payment of ten million USD (US$ 10,000,000) (βOption Grant Feeβ)
within [*] days after receipt by Novartis of an original invoice for such
amount from Quark in the form attached hereto as Exhibit H,
which invoice shall be issued no earlier than the Option Agreement
Effective Date.
|
Β
2.3
|
Exclusivity During Option
Period.Β Β Throughout the Option Period Quark shall not
initiate, solicit, discuss, negotiate or enter into any agreement or
arrangement with any Third Party regarding
any:
|
Β
|
(a)
|
license,
assignment or other disposition of any of its rights (also by way of
granting an option similar to the Option) in any Quark Compound, Product
or [*] Quark Technology to any Third Party;
or
|
Β
|
(b)
|
collaboration
or license agreement with any Third Party in connection with the
development and/or commercialization of any
[*].
|
Β
3.
|
GOVERNANCE
AND DEVELOPMENT DURING OPTION
PERIOD
|
Β
3.1
|
Joint Discussion
Committee.
|
Β
Β
|
(a)
|
The
Parties will establish a Joint Discussion Committee, composed of [*]
senior personnel of Quark and [*] senior personnel of Novartis (one (1) of
which will be the Partyβs Alliance Manager and which personnel for each
Party, collectively, shall have a general understanding of drug
manufacturing, development and commercialization
issues).Β Β Within [*] following the Option Agreement Effective
Date, each Party will designate its initial members to serve on the JDC
and notify the other Party of the dates of availability for the first
meeting of the JDC.Β Β Each Party may replace its representatives
on the JDC on written notice to the other
Party.
|
Β
Β
|
(b)
|
At
meetings of the JDC, Quark will update Novartis on, and the Parties
willΒ review and discuss, the status of Quarkβs Development activities
with respect to the Quark Compounds and the Product and any key issues
encountered in the Development of the Quark Compounds and the
Product.Β Β Without limiting Quarkβs obligations under
SectionΒ 3.3(a), Quark shall deliver any data and/or information
required to be delivered under Section 3.3(a) that has not yet been
delivered within a reasonable period of time prior to the next JDC
meeting.
|
Β
[ * ] = 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.
Β
Β
9
Β
Β
Β
|
(c)
|
The
JDC shall meet at least [*] per Calendar Year during the Option Period and
at such other times as the JDC or the Parties may agree.Β Β The
first meeting of the JDC shall be held as soon as reasonably practicable,
but in no event later than [*] following the Option Agreement Effective
Date.Β Β Meetings shall be held at such place or places as are
mutually agreed or by teleconference or videoconference.Β Β Each
Party may from time to time invite a reasonable number of participants who
are under obligations of confidentiality consistent with this Option
Agreement, in addition to its representatives, to attend JDC meetings in a
non-voting capacity, with the consent of the other Party (which shall not
be unreasonably withheld).
|
Β
Β
|
(d)
|
The
Parties agree that the costs incurred by each Party in connection with its
participation at any meetings under this Section 3.1 shall be borne solely
by such Party.
|
Β
Β
|
(e)
|
For
avoidance of doubt, during the Option Period, Quark retains all decision
making rights regarding Development of the Quark Compounds and the
Product.Β Β Quark will consider in good faith Novartisβ opinions
as discussed during the JDC meetings but may amend the DGF Phase II Trial
Protocol and the AKI Phase II Trial Protocol without Novartisβ
consent.
|
Β
3.2
|
Development During the Option
Period.
|
Β
Β
|
(a)
|
During
the Option Period, Quark will have the sole right to conduct and will be
responsible for conducting, at its sole expense, and shall use
Commercially Reasonable Efforts to carry out, all research and
preclinical, clinical and other development of the Quark Compounds and/or
Product; provided that
Novartis will provide, though its participation in the JDC, a reasonable degree
of know-how and technical advice with respect to such activities; provided
further that Quark shall not be obligated to conduct any research
and preclinical, clinical and other development of the Quark Compounds
and/or Product except as set forth below in Section
3.2(b).
|
Β
Β
|
(b)
|
Without
limiting Section 3.2(a) above, Quark will be responsible for completing,
and shall use Commercially Reasonable Efforts to complete, at its sole
cost and expense (except as provided below) and in accordance with the
Quark Development Plan, the DGF Phase II Trial and the AKI Phase II Trial,
including the Phase II Trial Reports and the AKI [*] and [*] safety
follow-up reports.Β Β The DGF Phase II Trial shall be completed in
accordance with the DGF Phase II Trial Protocol and the AKI Phase II Trial
shall be completed in accordance with the AKI Phase II Trial
Protocol.Β Β Notwithstanding the foregoing, if [*] as specified in
the [*], as applicable, after [*] specified therein by [*], [*], and the
Parties [*].Β Β For clarity, in no event shall Quark be obligated
to implement any changes to the Quark Development Plan, the DGF Phase II
Trial Protocol, or the AKI Phase II Trial Protocol that would have the
effect of [*] of the DGF Phase II Trial and/or the AKI Phase II
Trial.
|
Β
[ * ] = 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.
Β
10
Β
Β
Β
|
(c)
|
Quark
covenants that in performing all such development (i)Β it shall comply
with all applicable current international regulatory standards, including
cGMP, cGLP, cGCP and other rules, regulations and requirements and
(ii)Β it will not employ or use any person that has been debarred
under Section 306(a) or 306(b) of the U.S. Federal Food, Drug and Cosmetic
Act.
|
Β
Β
|
(d)
|
Subject
to the foregoing, during the Option Period, Quark shall retain decision
making authority on all matters in connection with the Development
(including all agreements with Third Parties) of the Quark Compounds
and/or Product and shall reasonably keep Novartis updated with respect to
any material decisions, data, results and draft agreements related
thereto.
|
Β
Β
|
(e)
|
Notwithstanding
anything to the contrary in this Option Agreement, if [*] do not [*] and
the [*] do not [*], and the [*], Quark may [*] and shall [*], provided, however, that
[*]. For a period of [*] after [*] and the [*], the Parties shall [*].
Β If the
Parties [*], such [*] will [*] and [*], Quark will [*], and Novartis [*],
and Quark shall [*], provided, however, that Novartis [*]. Quark shall [*]
after the Parties [*].Β Β Novartis shall [*].Β Β Such [*]
will be [*].
|
Β
3.3
|
Covenants Prior to Option
Exercise.
|
Β
Β
|
(a)
|
Information relating to Quark
Compounds and/or Product.Β Β During the Option Period,
Quark shall promptly notify Novartis of, and promptly provide to Novartis,
all data and/or information relating to the Quark Compounds and/or Product
that Quark generates during the Option Period which, in Quarkβs reasonable
judgment, would be relevant for Novartisβ decision concerning the exercise
of the Option, whether or not such data or information is specifically
requested by Novartis.
|
Β
Β
|
(b)
|
Regulatory
Developments.Β Β During the Option Period, Quark will
provide to Novartis copies of all substantive written communications
between Quark (or its Affiliates) and Regulatory Authorities related to
any Quark Compound or Product.Β Β Novartis shall have the right to
have representatives of Novartis attend (as observers) all meetings
between Quark (or its Affiliates) and any Regulatory Authority relating to
the DGF Phase II Trial and/or the AKI Phase II Trial, except to the extent
prohibited by applicable law or
regulation.
|
Β
[ * ] = 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.
Β
11
Β
Β
Β
|
(c)
|
Due
Diligence.Β Β During the Option Period, Quark shall permit
Novartis to conduct a reasonable due diligence investigation to enable
Novartis to make an informed decision on whether or not to exercise the
Option and its other rights hereunder.Β Β The key due diligence
items shall include: (i)Β discussions with Quark on interactions with
the Regulatory Authorities relating to the Quark Compounds and/or the
Product and all past, current, and planned related clinical trials
relating to Quark Compounds and/or Product, and review of all filings and
correspondence with Regulatory Authorities relating to the Quark Compounds
and/or the Product, including minutes of meetings and telephone calls with
such Regulatory Authorities regarding such matters; (ii)Β review of
all pre-clinical and clinical data, and of the formulation composition and
CMC sections of Regulatory Filings, in each case, related to Quark
Compounds and/or Product; (iii)Β review of all contracts related to
the Development, manufacturing or Commercialization of the Quark Compounds
or the Products, including all agreements entered into by Quark during the
Option Period; (iv)Β review of all intellectual property relating to
Quark Compounds and/or Product; (v) access to any contract research
organization(s) and contract manufacturer(s) of the Quark Compounds of
Product, including for purposes of conducting quality audits if requested
by Novartis; and (vi) any other items reasonably related to Quark
Compounds and/or Product or the License, as the case may
be.Β Β Such due diligence items shall be provided by Quark
promptly upon reasonable request by Novartis from time to time, but shall
be subject to Third Party confidentiality obligations of Quark which will
be clearly identified and listed before entering due diligence (provided
that if information material to Novartisβs decision about exercising its
Option is subject to a Third Party confidentiality obligation, Quark shall
so advise Novartis and work with Novartis to enable Novartis to make its
decision about Option exercise in an informed
manner).
|
Β
Β
|
(d)
|
Financial
Disclosures.Β Β During the Option Exercise Period, Quark
shall promptly notify Novartis:
|
Β
Β
|
(i)
|
of
the occurrence of the following:
|
Β
Β
|
(A)
|
Quarkβs
[*] fall below US$[*];
|
Β
Β
|
(B)
|
Quarkβs
[*] (excluding [*]) exceed US$[*], and any increase in Quarkβs [*] of more
than US$[*]; or
|
Β
Β
|
(C)
|
any
increase of more than US$[*] in Quarkβs [*] as compared to
[*],
|
Β
it being
agreed that, if any of the foregoing occurs, the Parties shall discuss possible
alternatives which may include (but are not limited to) [*], provided that, for
the sake of clarity, the occurrence of an event described in this Section
3.3(d)(i), in the absence of other circumstances, shall not be considered [*]
and such notification thereof by Quark shall not be considered [*] by Quark
which would give rise to [*] in accordance with [*];
Β
[ * ] = 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.
Β
12
Β
Β
(ii)Β Β Β Β Β Β Β Β Β if
and when Quark first becomes aware of any proceedings, or the likely occurrence
of any proceedings, in connection with an Insolvency Event or other similar
arrangement or proceeding in regard to Quark (such notice, an βInsolvency Event Notice by
Quarkβ).
Β
3.4
|
Option
Acceleration.
|
Β
Β
|
(a)
|
In
the event that Novartis reasonably determines, during the Option Exercise
Period, that [*] has or is likely to occur in connection with [*] it may
issue written notice to Quark of such determination (such notice,
[*]).
|
Β
Β
|
(b)
|
Within
[*] of any [*] by Quark or any [*] by Novartis, Novartis may exercise the
Option by notice in writing to Quark, which will have the effect described
in Section 8.3 of Exhibit A
hereto.
|
Β
Β
|
(c)
|
Nothing
in this Section 3.4 shall limit any other rights of Novartis under this
Option Agreement, and for clarity, nothing in this Section 3.4 shall
preclude Novartis from exercising the Option at any later time during the
Option Period in the event that it does not exercise the Option under this
Section 3.4.
|
Β
3.5
|
Delivery of Study
Reports.
|
Β
Β
|
(a)
|
Quark
shall deliver to Novartis a draft of each of the Phase II Trial Reports
except the DGF DMC Top Line Interim Report and the AKI First Interpretable
Results, which will each only be delivered in a final form (all reports
shall, in each case, include all available raw data in a user-friendly
electronic format, as well as primary and secondary efficacy endpoint
data, all material efficacy, safety, clinical and medical data, and any
other information related thereto and shall be produced in a substantially
similar form as the report template provided by Novartis from time to
time) (each, a βDraft
Phase II Trial Reportβ) no more than [*] following the date on
which the applicable Draft Phase II Trial Report becomes available to
Quark in essentially complete form.
|
Β
Β
|
(b)
|
Each
Draft Phase II Trial Report shall be accompanied by a report setting forth
all other material efficacy, safety, clinical and medical data,
manufacturing data and a summary of the data generated from the
pre-clinical and clinical studies in sufficient detail so as to reasonably
demonstrate whether efficacy has been achieved in accordance with defined
endpoints and whether any unexpected or untoward effects resulted from
such studies which would limit further development of the
Product.
|
Β
[ * ] = 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.
Β
13
Β
Β
Β
|
(c)
|
For
a period of [*] from and after the delivery of each Draft Phase II Trial
Report, Novartis shall have the right to request from Quark such
additional information then in the possession of or readily available to
Quark as Novartis may reasonably require in order to make a scientific,
legal and business evaluation of the development and commercialization
potential of the Product.Β Β Quark shall promptly respond in
writing to any questions Novartis may have regarding the applicable Draft
Phase II Trial Report and the report provided under Section 3.5(b), and
shall promptly provide or make available any additional information
relating thereto requested by Novartis, in any case, within [*] following
any such questions and/or request.
|
Β
Β
|
(d)
|
Novartis
will within [*] of receiving a Draft Phase II Trial Report issue a written
notice to Quark either confirming or disputing whether such Draft Phase II
Trial Report meets the requirements set forth in the relevant Phase II
Trial Report definition under this Option Agreement, such confirmation not
to be unreasonably withheld.Β Β In the event such written notice
disputes whether such Draft Phase II Trial Report meets the requirements
set forth in the relevant Phase II Trial Report definition under this
Option Agreement, such written notice shall include a list of specific
deficiencies to be corrected in the final version of the applicable Phase
II Trial Report.
|
Β
Β
|
(e)
|
Quark
will provide Novartis with the final version of the following Phase II
Trial Reports:
|
Β
Β
|
(i)
|
The
DGF DMC Top Line Interim Report within [*] of the final dosing of the last
patient for each interim analysis in the DGF Phase II
Trial;
|
Β
Β
|
(ii)
|
The
DGF [*] Report within [*] of the final dosing of the last patient for the
DGF Phase II Trial;
|
Β
Β
|
(iii)
|
The
DGF Final Report within [*] of the final dosing of the last patient for
the DGF Phase II Trial;
|
Β
Β
|
(iv)
|
The
AKI First Interpretable Results within [*] of the final dosing of the last
patient in the AKI Phase II Trial;
and
|
Β
Β
|
(v)
|
The
AKI Final Report within [*] of the final dosing of the last patient for
the AKI Phase II Trial.
|
Β
[ * ] = 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.
Β
14
Β
Β
Each such
Phase II Trial Report shall be deemed to have been accepted by Novartis [*]
after it was first made available to Novartis in final and complete form,
provided that such report reasonably addresses any deficiencies in the
corresponding Draft Phase II Trial Report that were identified by Novartis under
Section 3.5(d) above.Β Β If Novartis believes the report, as submitted
by Quark in final and complete form, did not reasonably address such
deficiencies, it shall promptly advise Quark and the Parties shall seek to
resolve such dispute.Β Β If the Parties do not reach agreement on such
matter, either Party may submit the issue to an arbitration under Section
10.5.Β Β If the arbitration rules [*] the applicable [*] shall be [*]
but the [*] with respect to [*] shall be [*] following receipt of the written
decision of arbitration. If the arbitration rules [*], then [*] in accordance
with the ruling of the arbitrator and shall [*], and the [*].
Β
Β
|
(f)
|
For
a period of [*] from and after the delivery of the DGF DMC Top Line
Interim Report, the AKI First Interpretable Results, the DGF [*] Report
and the AKI Final Report, Novartis shall have the right to request from
Quark such further additional information then in the possession of or
readily available to Quark as Novartis may reasonably require in order to
make a scientific, legal and business evaluation of the Development and
Commercialization potential of the Product.Β Β Quark shall
promptly respond in writing to any questions Novartis may have regarding
the DGF DMC Top Line Interim Report, the AKI First Interpretable Results,
the DGF [*] Report or the AKI Final Report, as applicable, and the report
provided under Section 3.5(b), and shall promptly provide or make
available any additional information relating thereto requested by
Novartis, in any case, within [*] following any such questions and/or
request.
|
Β
4.
|
EXERCISE
OF OPTION AND GRANT OF LICENSE
|
Β
4.1
|
Exercise of Option and Grant of
License.
|
Β
Β
|
(a)
|
Subject
to Sections 4.1(a)(i) and 4.1(a)(ii) below, Novartis may exercise the
Option by written notice to Quark (βNovartis Option Exercise
Noticeβ) during the Option Period pursuant to Section 8.1(a),
8.1(b),8.1(c) or 8.1(d) of Exhibit
A.
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Within
[*] ofΒ Β the [*] of (A) the date on which [*] or (B) the date on which
[*], Novartis shall provide written notice to Quark [*]. [*], within [*] of [*],
[*] by written notice that [*]. If Novartis [*] during such [*] to provide [*]
to exercise the Option pursuant to [*]. The [*] shall not
exceed [*]. The [*] to provide [*].Β Β If [*] within such [*], Novartis
shall [*] and [*] shall, [*] to exercise the Option [*].
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β The
Novartis Option Exercise Notice shall set forth which provision in Sections
8.1(a) through (d) in Exhibit A shall
apply.Β Β For clarity, except as provided in Section 3.4 above, the
Option may only be exercised by Novartis pursuant to one of the provisions set
forth in Sections 8.1(a) through (d) of Exhibit
A.
Β
[ * ] = 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.
Β
15
Β
Β
Β
|
(b)
|
Unless
exercised by Novartis, the Option shall expire in its entirety as
follows:
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Except
as provided in Sections 4.1(b)(ii), 4.1(b)(iii), 4.1(b)(iv) or 4.1(b)(v), the
Option shall expire in its entirety [*] after the [*] of (A) [*] or (B)
[*].
Β
(ii)Β Β Β Β Β Β Β Β Β Β In
the event either [*] or [*], and [*], the Option shall expire in its entirety
upon the expiry of [*].
Β
(iii)Β Β Β Β Β Β Β Β Β In
the event that (A) both [*] and [*], or [*], and (B) either [*] or [*], the
Option shall expire in its entirety on the date that is [*] after the earlier of
(X) the date on which the [*] that [*] was accepted by Novartis as set forth [*]
or (Y) the date on which the [*] that [*] was accepted by Novartis as set forth
[*].
Β
(iv)Β Β Β Β Β Β Β Β Β In
the event Quark [*] as set forth[*]and the Parties [*] the Parties shall [*],
the Option shall expire in its entirety [*].
Β
(v)Β Β Β Β Β Β Β Β Β Β In
the event that (A) both [*] and [*] and (B) neither [*] nor [*] and Novartis
does not exercise the Option pursuant to Section 4.1(b)(iv), the Option shall
expire in its entirety on the date that is [*] after the later of (X) the date
on which the [*] was accepted by Novartis [*] or (Y) the date on which the [*]
was accepted by Novartis [*]. If, after expiration of the Option pursuant to
this Section 4.1(b)(v), Quark [*] or otherwise [*] with respect to [*] or [*],
Quark [*]. Novartis will [*]. If Novartis [*], or if [*] during such [*], then
Quark [*].
Β
(vi)Β Β Β Β Β Β Β Β Β In
the event Quark believes the Option is about the expire under the provisions of
any of paragraphs (i)-(v) above, Quark shall give written notice to Novartis not
less than [*] and nor more than [*] prior to the date on which Quark believes
such expiration would occur.
Β
Β
|
(c)
|
Quark
hereby grants to Novartis, effective as of the License Effective Date, an
exclusive (even as to Quark), royalty-bearing, sub-licensable license
under the Quark Technology and Quarkβs interest in any Joint Development
Technology to research, Develop, make, have made, use, import, export,
offer for sale, sell and otherwise Commercialize the Quark Compounds and
the Product in the Field in the Territory and to have the foregoing done
on its behalf (the βLicenseβ) on the terms
and conditions set forth in Exhibit
A.Β Β The Parties acknowledge and agree that Exhibit A sets
forth all the material terms and conditions of the
License.Β Β Such License (and the Partiesβ rights and obligations
thereunder) shall automatically become effective on the License Effective
Date without the need for further action by the
Parties.
|
Β
[ * ] = 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.
Β
16
Β
Β
Β
|
(d)
|
If
Novartis does not exercise the Option within the Option Period, then: (i)
the Option shall no longer be exercisable and the License granted under
Section 4.1(c) shall be of no force or effect; and (ii) Quark will be free
to initiate, solicit, discuss, negotiate or enter into any agreement or
arrangement with any Third Party regarding licensing or other disposition
of any rights to the Quark Technology, the Quark Compounds or the Product,
without further obligation to
Novartis.
|
Β
Β
|
(e)
|
Attached
hereto as Exhibit B is a
decision tree illustrating the option exercise mechanism set forth in this
Section 4.1 and in Sections 8.1 and 8.2 of Exhibit
A.Β Β Such decision tree is included herein solely for
illustrative purposes.Β Β To the extent there exists any
inconsistencies between Exhibit B and
the language in the body of this Option Agreement or between Exhibit B and
the language in Exhibit A, the
language in the body of this Option Agreement and/or the language in Exhibit A (as
applicable) shall control.
|
Β
4.2
|
Antitrust
Filings.Β Β Upon request by Novartis (whether during the
Option Period or following exercise of the Option by Novartis), Quark
agrees to cooperate with Novartis and to prepare and make appropriate
filings under the HSR Act and other antitrust requirements relating to the
License as soon as reasonably practicable after the Option Exercise Date
(βHSR Filing
Dateβ).Β Β The Parties agree to cooperate in the antitrust
clearance process and to furnish promptly to the Federal Trade Commission
(FTC), the Antitrust Division of the Department of Justice and any other
agency or authority, any information reasonably requested by them in
connection with such filings.Β Β In the event a provision of the
License needs to be deleted or substantially revised in order to obtain
regulatory clearance of this transaction, the Parties will negotiate in
good faith in accordance with Section 10.3.Β Β Each Party shall
bear its own expenses in connection with the Partiesβ cooperation under
this Section 4.2, except that Novartis shall pay all filing fees due with
respect to any filings under the HSR
Act.
|
Β
4.3
|
Cooperation and Transfer of
Technology
|
Β
Β
|
(a)
|
Within
[*] of the License Effective Date (or such longer period as may be agreed
between the Parties), Quark, without additional consideration, shall
disclose to Novartis or its designated Affiliate all Quark Know-How in
existence at the License Effective Date.Β Β Such disclosures shall
include all such Quark Know-How pertaining to the formulation, manufacture
and Development of the Quark Compounds and/or Product and any other data,
information and documents known to Quark which may be necessary or useful
to Novartis to research, Develop, manufacture, register, use or
Commercialize the Quark Compounds and/or Product and practice the License
efficiently.Β Β Quark will also provide reasonable assistance to
Novartis or its designated Affiliate in connection with understanding and
using the Quark Know-How within the scope of the License.Β Β In
providing Know-How under this paragraph (a), Quark shall deliver written
and electronic materials to Novartis, during the period of [*] from the
License Effective Date, such assistance from its professional staff for
meetings (including travel to sites other than Quark facilities) telephone
calls, studies, reports and other assistance as may reasonably required by
Novartis to enable it to understand and use the Quark Know-How, shall be
provided without charge to Novartis. After such [*] period and during the
term of the License Agreement, Quark shall ensure that its professional
staff shall continue to be available as reasonably required at Quark
facilities and by telephone, without charge to Novartis, provided that
[*].
|
Β
[ * ] = 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.
Β
17
Β
Β
Β
|
(b)
|
Within
[*] following the License Effective Date (or such longer period as may be
agreed between the Parties), Quark or its Affiliates shall, provide to
Novartis or its designated Affiliate such quantities of the Quark
Compounds and/or Product in Quarkβs possession as may be reasonably
requested by Novartis, which supplies shall be provided to Novartis at
[*].
|
Β
Β
|
(c)
|
During
the term of the License, Quark shall fully cooperate with and provide
reasonable assistance to Novartis or its designee, through documentation,
consultation and face-to-face meetings, to enable Novartis or its designee
in an efficient and timely manner to proceed with Development and
manufacturing of the Quark Compounds and/or Product and to obtain all
appropriate regulatory approvals for manufacturing (including
qualification by the applicable Regulatory Authority of manufacturing
sites), provided that during the period of [*] from the License Effective
Date, such assistance (including travel to sites other than Quark
facilities) shall be provided without charge to Novartis. After such [*]
period such assistance shall, where provided at Quark facilities or by
telephone, continue to be provided without charge, provided that
[*].
|
Β
Β
|
(d)
|
During
the period from the License Effective Date until the First Commercial Sale
of the Quark Compounds and/or Product under the License, Quark shall make
appropriate personnel available to assist Novartis or its designee from
time to time as reasonably requested by Novartis, and shall provide the
appropriate personnel of Novartis or its designee with access to the
personnel and manufacturing and other operations of Quark for such periods
of time and in such manner as is reasonable in order to familiarize the
personnel of Novartis or its designee with Quark Know-How relating to the
Development and manufacture of the Quark Compounds and/or Product and the
application of the same, provided that during the period of [*] from the
License Effective Date, such assistance (including travel to sites other
than Quark facilities) shall be provided without charge to Novartis. After
such [*] period such assistance shall, where provided at Quark facilities
or by telephone, continue to be provided without charge, provided that
[*].
|
Β
[ * ] = 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.
Β
18
Β
Β
4.4
|
Transition
Plan.Β Β Within [*] of the License Effective Date, the
Parties shall agree to a plan (βTransition Planβ) for
the transfer to Novartis of all Development and manufacturing activities
then being undertaken by Quark, taking into account Quarkβs obligations to
complete the DGF Phase II Trial and/or the AKI Phase II Trial, and any
other ongoing clinical or pre-clinical studies, as set forth in Section
5.1(a) of Exhibit A.Β Β Quark shall, without additional
consideration, transition all such activities to Novartis in accordance
with the Transition Plan.
|
Β
5.
|
CONFIDENTIALITY
|
Β
5.1
|
Duty of
Confidence.
|
Β
Β
|
(a)
|
Subject
to the other provisions of this Article 5, all Confidential Information
disclosed by a Party or its Affiliates under this Option Agreement will be
maintained in confidence and otherwise safeguarded by the recipient
Party.Β Β The recipient Party may only use the Confidential
Information for the purposes of this Option Agreement (including the
License granted hereunder).Β Β Subject to the other provisions of
this Article 5, each Party shall hold as confidential such Confidential
Information of the other Party or its Affiliates in the same manner and
with the same protection (in no case less than reasonable care) as such
recipient Party maintains its own confidential
information.Β Β Subject to the other provisions of this Article 5,
a recipient Party may only disclose Confidential Information of the other
Party to employees, agents, contractors, consultants and advisers of the
Party and its Affiliates and sublicensees to the extent reasonably
necessary for the purposes of, and for those matters undertaken pursuant
to, this Option Agreement; provided that
such Persons are bound to maintain the confidentiality of the Confidential
Information in a manner consistent with the confidentiality provisions of
this Option Agreement.
|
Β
Β
|
(b)
|
During
the term of this Option Agreement Quark shall take all commercially
reasonable precautions to protect the confidentiality of the Quark Program
Confidential Information.
|
Β
5.2
|
Exceptions.Β Β The
obligations under this Article 5 shall not apply to any information to the
extent the recipient Party can demonstrate by competent evidence that such
information:
|
Β
Β
|
(a)
|
is
(at the time of disclosure) or becomes (after the time of disclosure)
known to the public or part of the public domain through no breach of this
Option Agreement by the recipient Party or its
Affiliates;
|
Β
Β
|
(b)
|
was
known to, or was otherwise in the possession of, the recipient Party or
its Affiliates prior to the time of disclosure by the disclosing Party or
any of its Affiliates;
|
Β
Β
|
(c)
|
is
disclosed to the recipient Party or an Affiliate on a non-confidential
basis by a Third Party who is entitled to disclose it without breaching
any confidentiality obligation to the disclosing Party or any of its
Affiliates; or
|
Β
[ * ] = 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.
Β
19
Β
Β
Β
|
(d)
|
is
independently developed by or on behalf of the recipient Party or its
Affiliates, as evidenced by its written records, without access or
reference to the Confidential Information disclosed by the disclosing
Party or its Affiliates under this Option
Agreement.
|
Β
Specific
aspects or details of Confidential Information shall not be deemed to be within
the public domain or in the possession of the recipient Party merely because the
Confidential Information is embraced by more general information in the public
domain or in the possession of the recipient Party.Β Β Further, any
combination of Confidential Information shall not be considered in the public
domain or in the possession of the recipient Party merely because individual
elements of such Confidential Information are in the public domain or in the
possession of the recipient Party unless the combination and its principles are
in the public domain or in the possession of the recipient Party.
Β
5.3
|
Authorized
Disclosures.Β Β In the event the recipient Party is
required to disclose Confidential Information of the disclosing Party by
law or regulation or in connection with bona fide legal process, such
disclosure shall not be a breach of this Option Agreement; provided that
the recipient Party (i)Β informs the disclosing Party as soon as
reasonably practicable of the required disclosure; (ii)Β limits the
disclosure to the required purpose; and (iii)Β at the disclosing
Partyβs reasonable request and expense, assists in an attempt to object to
or limit the required disclosure.
|
Β
5.4
|
Ongoing Obligation for
Confidentiality.Β Β In the event that Novartis does not
exercise the Option before the end of the Option Period, each Party and
its Affiliates shall immediately return to the other Party or destroy any
Confidential Information disclosed by the other Party during the Option
Period, except for one copy which may be retained in its confidential
files for archive purposes.
|
Β
5.5
|
Confidentiality Obligations
Under License.Β Β For clarity, in the event that Novartis
exercises the Option, the provisions of Article 11 of Exhibit A shall
apply with respect to all Confidential Information disclosed by a Party to
the other Party under this Option Agreement, and the provisions of this
Article 5 shall be of no further force or effect with respect to such
Confidential Information.
|
Β
6.
|
INTELLECTUAL
PROPERTY
|
Β
6.1
|
Ownership of Development
Technology.Β Β Each Party agrees promptly to disclose to
the other Party all Know-How and Patent Rights created, conceived, reduced
to practice or invented by either Party, its Affiliates, agents or by
Third Parties acting on its behalf, as a direct result of a Party
performing activities under this Option Agreement.Β Β As between
the Parties, (a)Β title to all Quark Development Technology shall be
owned by Quark, (b)Β title to all Novartis Development Technology
shall be owned by Novartis, and (c)Β title to all Joint Development
Technology shall be jointly owned by Quark and Novartis as contemplated
under US patent laws, including 35 U.S.C. Β§
262.
|
Β
[ * ] = 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.
Β
20
Β
Β
6.2
|
Joint Development
Technology.Β Β Subject to the rights herein including the
Option, and if the Option is exercised, the License, each Party shall have
the right to practice and exploit Joint Development Technology, without
any obligation to account to the other for profits, or to obtain any
approval of the other Party to license, assign or otherwise exploit Joint
Development Technology, by reason of joint ownership thereof, and each
Party hereby waives any right it may have under the laws of any
jurisdiction to require any such approval or accounting; and to the extent
there are any applicable laws that prohibit such a waiver, each Party will
be deemed to so consent.Β Β Should one or both Parties decide to
file a patent application related to or claiming Joint Development
Technology the Parties shall refer the preparation and filing of such
application(s) to a mutually agreed-upon outside intellectual property
counsel, the expenses of which shall be borne equally by the
Parties.Β Β Either Party may determine that it is no longer
interested in supporting the continued prosecution or maintenance of a
particular patent or patent application claiming Joint Development
Technology in a particular country or jurisdiction, in which
case:Β Β (i) the disclaiming Party shall, if requested by the
other Party, assigns its ownership interest in such patent or patent
applications in such country or jurisdiction to the other Party for no
additional consideration; and (ii) if such assignment is effected, the
disclaiming Party and any Affiliates thereof would have immunity from suit
under such patent or patent application in the applicable country or
jurisdiction.Β Β In the event of an infringement anywhere in the
world of any Patent Rights which comprise Joint Development Technology,
the Parties shall jointly decide how to proceed.Β Β If one Party
brings any action to enforce Patent Rights that has been agreed upon by
the Parties, the other Party agrees to be joined as a party if necessary
to prosecute the action and to give the first Party reasonable assistance
and authority to file and prosecute the
action.
|
Β
6.3
|
Data.Β Β All
data generated by Quark in the course of the Development of the Quark
Compounds and/or the Product during the term of the Option Agreement shall
be owned by Quark and included in the Quark Know-How.Β Β All data
generated by Novartis in the course of the Development of the Quark
Compounds and/or the Product during the term of the Option Agreement shall
be owned by Novartis.
|
Β
6.4
|
Disputes as to
Inventorship.Β Β Should the Parties fail to agree regarding
inventorship of any invention made in the conduct of activities under this
Option Agreement, the Parties shall refer the matter to a mutually
agreed-upon outside counsel, with expertise in intellectual property, for
resolution, the expenses of which shall be borne equally by the
Parties.Β Β All determinations of inventive contribution for
inventions arising hereunder shall be determined under United States
patent law.
|
Β
6.5
|
No Implied
Rights.Β Β No license or other right is or shall be created
or granted hereunder by implication, estoppel or otherwise, except as
expressly provided for herein.
|
Β
[ * ] = 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.
Β
21
Β
Β
6.6
|
Infringement of Third Party
Rights.Β Β If Quark identifies any Third Party intellectual
property rights that it believes would be relevant to the Development,
manufacture, use or Commercialization of the Quark Compounds and/or the
Product, Quark will so notify Novartis and the Parties shall confer to
discuss the scope and relevance of such intellectual property rights and
shall discuss whether and on what terms Quark should attempt to obtain
rights to such intellectual property rights.Β Β In the event that
Quark wishes to enter into any agreement under which Quark would assign or
grant to Novartis a sublicense if Novartis exercises the Option, Quark
shall use Commercially Reasonable Efforts to negotiate and execute a
license (or similar) agreement (each such agreement an βOption Term Agreementβ)
to acquire rights to such intellectual property rights that is
(i)Β [*], and (ii)Β is [*].Β Β Quark shall submit to the
JDC a draft of such agreement for Novartis to review and Quark shall
consider any comments Novartis may have in good faith.Β Β Further,
Quark shall send a copy of any such agreement entered into with a Third
Party to Novartis within [*] following execution of any such
agreement.
|
Β
6.7
|
Patent
Filings.Β Β Prior to filing any patent application in Quark
Patents or any amendment thereto, and prior to any decision not to file
any patent application in Quark Patents or amendment thereto or to allow
any patent or patent application in Quark Patents to lapse or become
abandoned, or prior to any submission to the U.S. Patent and Trademark
Office or similar foreign office, Quark shall provide to Novartis a
written draft of any such filing or submission or written notice of any
decision to not file such application, abandon an application or to allow
any patent or patent application to lapse, as the case may be, in
accordance with the notice provisions set forth in Section 10.9 within a
reasonable time prior to such filing, submission or decision for Novartis
to review and comment, in good faith, on such filing, submission or
decision, provided, that
Quark shall consider such comments in good faith but Quark retains final
decision-making authority as to all such filings, submissions and
decisions.
|
Β
6.8
|
Requested
Divisionals.Β Β Quark has identified to Novartis, as of the
Option Agreement Effective Date, those Quark Patents which have apparent
utility with respect to Quark activities both within and outside the scope
of this Option Agreement or the License Agreement (Table 6 of draft
Exhibit A to Exhibit A).Β Β Within [*] following the Option
Agreement Effective Date, Novartis shall identify to Quark those
divisional patent applications that Novartis would like to have filed
specific to [*] of such Quark Patent, and Quark shall thereafter [*] such
divisional patent applications and patents issuing
therefrom.Β Β The Parties shall cooperate to make such process
practical and efficient.
|
Β
7.
|
TERM
AND TERMINATION
|
Β
7.1
|
Term.Β Β Unless
earlier terminated as set forth in this Article 7, the term of this Option
Agreement will commence upon the Option Agreement Effective Date and
continue until the end of the Option
Period.Β Β
|
Β
7.2
|
Termination by Novartis Without
Cause.Β Β Novartis may terminate this Option Agreement
without cause at any time after the Option Agreement Effective Date by [*]
prior written notice to Quark.Β Β If this Option Agreement is
terminated by Novartis pursuant to this SectionΒ 7.2, then, except as
set forth in SectionΒ 7.4, neither Novartis nor Quark shall have any
further obligations or liabilities under this Option
Agreement.
|
Β
[ * ] = 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.
Β
22
Β
Β
7.3
|
Termination by Quark for
Cause.Β Β If Novartis commits a material breach of this
Option Agreement, Quark may give written notice to Novartis specifying the
claimed particulars of such material breach, and in the event such
material breach is not cured within [*] after such notice, Quark shall
have the right thereafter to terminate this Option Agreement immediately
by giving written notice to Novartis to such effect.Β Β Any such
termination shall be without prejudice to any damages or other legal or
equitable remedies to which Quark may be entitled from
Novartis.
|
Β
7.4
|
Survival.Β Β Expiration
or termination of this Option Agreement or the License shall not relieve
the Parties of any obligation accruing prior to such expiration or
termination.Β Β The provisions of [*], and the provisions of
Article 5 (Confidentiality) shall survive the termination or expiration of
this Option Agreement for a period of [*], and the provisions of
ArticleΒ 6 (Intellectual Property, except for Sections 6.6, 6.7 and
6.8) shall survive the termination or expiration of this Option Agreement
indefinitely.Β Β Notwithstanding the foregoing, in the event that
Novartis exercises the Option before the end of the Option Period, to the
extent that any surviving provision of this Option Agreement is
inconsistent with the provisions of the License, it shall be superseded
and replaced by the provisions of the
License.
|
Β
8.
|
REPRESENTATIONS,
WARRANTIES, COVENANTS AND
INDEMNITIES
|
Β
8.1
|
Representations, Warranties and
Covenants by Each Party.Β Β Each Party represents,
warrants, covenants and/or agrees (as applicable) to the other as of the
Option Agreement Effective Date
that:
|
Β
Β
|
(a)
|
it
is a corporation duly organized, validly existing, and in good standing
under the laws of its jurisdiction of
formation;
|
Β
Β
|
(b)
|
it
has all requisite corporate power and authority to execute, deliver, and
perform this Option Agreement, and has taken all corporate action required
by law and its organizational documents to authorize the execution and
delivery of this Option Agreement and the consummation of the transactions
contemplated by this Option
Agreement;
|
Β
Β
|
(c)
|
the
execution and delivery of this Option Agreement by such Party and the
performance by it of its obligations hereunder have been duly and validly
authorized by all necessary corporate action on the part of such
Party;
|
Β
Β
|
(d)
|
this
Option Agreement has been duly executed and delivered by such
Party;
|
Β
Β
|
(e)
|
this
Option Agreement constitutes a valid and binding agreement enforceable
against it in accordance with its
terms;
|
Β
Β
|
(f)
|
it
will use all reasonable precaution to preserve the confidentiality of this
Option Agreement (including any exhibits attached hereto) and the terms
hereof;
|
Β Β
[ * ] = 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.
Β Β
23
Β
Β
|
(g)
|
except
for any HSR or other merger clearance filings that may be required, all
consents, approvals and authorizations from all governmental authorities
or other Third Parties required to be obtained by such Party in connection
with this Option Agreement, and the transactions contemplated hereby, have
been obtained;
|
Β
Β
|
(h)
|
the
execution and delivery of this Option Agreement and all other instruments
and documents required to be executed pursuant to this Option Agreement,
and the consummation of the transactions contemplated hereby, do not and
shall not (i)Β conflict with or result in a breach of any provision of
its organizational documents, (ii) result in a breach of any other
agreement to which it is a party; or (iii) violate any law;
and
|
Β
Β
|
(i)
|
neither
it nor its respective stockholders, directors, officers or employees have
retained any broker, finder, or investment banker in connection with this
Option Agreement or the transactions contemplated hereby, nor, in the case
of Quark, does or will it, or any of its directors, officers or employees
owe any fee or other amount to any broker, finder, or investment banker in
connection with the Option Agreement or the transactions contemplated
hereby.
|
Β
8.2
|
Representations and Warranties
by Each Party Regarding License Agreement.Β Β Each Party
represents and warrants to the other that, upon exercise by Novartis of
the Option before the end of the Option Period, the terms and conditions
set forth on Exhibit A to
this Option Agreement shall constitute a complete, valid and binding
agreement enforceable against it in accordance with such
terms.
|
Β
8.3
|
Representations and Warranties
by Quark.Β Β Quark represents and warrants to Novartis as
of the Option Agreement Effective Date
that:
|
Β
Β
|
(a)
|
Quark
has the right to grant to Novartis the rights that Quark purports to grant
Novartis hereunder, including the right to grant exclusive licenses to the
Quark Compounds and the Product under the Quark Patents and Quark
Know-How;
|
Β
Β
|
(b)
|
Quark
has not granted to any Third Party, including any academic organization or
agency, any rights to the Quark Compounds or
Product;
|
Β
Β
|
(c)
|
all
of its employees, officers, and consultants involved or to be involved in
the research or Development of the Quark Compound or Product have executed
agreements or have existing obligations under applicable laws requiring
assignment to Quark of all inventions made during the course of and as the
result of their association with Quark and obligating the individual to
maintain as confidential Quarkβs Confidential Information as well as
confidential information of other parties (including Novartis and its
Affiliates) which such individual may
receive;
|
Β
Β
|
(d)
|
Quark
has not granted any Third Party rights that would otherwise interfere or
be inconsistent with Novartisβ rights hereunder in a material manner, and
there are no license or option agreements or other arrangements to which
Quark or any of its Affiliates is a party relating to the Product, Quark
Compounds, Quark Patents, Quark Know-How or otherwise that would limit the
rights granted to Novartis under this Option Agreement or that restrict or
will result in a restriction on Novartisβ ability to research, Develop,
manufacture, register, use or Commercialize the Quark Compounds and the
Product in the Territory;
|
Β
[ * ] = 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.
Β
24
Β
Β
|
(e)
|
[*]
the research, Development, use and manufacture of the Quark Compounds and
Products has been conducted by Quark without infringing or
misappropriating the intellectual property rights of any Third
Party;
|
Β
Β
|
(f)
|
[*]
neither Quark nor any of its Affiliate has committed any act which amounts
to a material breach of any of Quarkβs obligations under
anyΒ agreement under which it obtains rights to any of the Quark
Technology;
|
Β
Β
|
(g)
|
(i)
neither Quark nor any employee, agent or subcontractor of Quark involved
or to be involved in the research or Development of the Quark Compounds or
the Product has been debarred under Subsection (a) or (b) of Section 306
of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); (ii) no
Person who is debarred under Subsection (a) or (b) of Section 306 of said
Act will be employed by Quark in the performance of any activities
hereunder; and (iii) no Person on any of the FDA Clinical Investigator
Enforcement Lists (including, but not limited to, the (1)
Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate
Assurances List) will participate in the performance of any activities
hereunder.
|
Β
Β
|
(h)
|
Notwithstanding
anything to the contrary contained in this Option Agreement, Quark has [*]
and [*] that would be [*] to [*] in connection with this Option Agreement.
[*], the [*] provided to Novartis regarding the Quark Compounds and the
Products are true and complete in all material
respects.
|
Β
8.4
|
Covenants of
Quark.Β Β Quark covenants and agrees that during the term
of this Option Agreement:
|
Β
Β
|
(a)
|
neither
it, nor any of its Affiliates, will grant any interest in the Quark
Patents or Quark Know-How which is inconsistent with the terms and
conditions of this Option Agreement, nor shall Quark assign its right,
title or interest in or to the Quark Patents or Quark Know-How to any
Third Party and will use all reasonable precautions to preserve the
confidentiality of the Quark
Know-How;
|
Β
Β
|
(b)
|
neither
it nor any of its Affiliates shall grant to any Third Party, including any
academic organization or agency, any rights to the Quark Compounds or
Product;
|
Β
Β
|
(c)
|
it
will not amend or modify the terms of any agreement under which it obtains
rights to any of the Quark Technology in a way that materially affects
Novartisβ rights under this Option Agreement or the License without the
prior written consent of Novartis;
|
Β
[ * ] = 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.
Β
25
Β
Β
|
(d)
|
it
will not exercise any right to terminate any agreement under which it
obtains rights to any of the Quark Technology without the prior written
consent of Novartis;
|
Β
Β
|
(e)
|
Quark
and its Affiliates will comply with, perform and observe in all material
respects all obligations underΒ each agreement under which it obtains
rights to any of the Quark Technology, and will not commit any act or fail
to perform any obligation which would amount to a default or event of
default or which, with the giving of notice, the lapse of time or the
happening of any other event or condition would become a default or event
of default thereunder or give rise to any right of the applicable
counterparty to terminate any such agreement or any part
thereof;
|
Β
Β
|
(f)
|
it
will use all reasonable precautions to preserve the confidentiality of
this Option Agreement (including any exhibits attached hereto) and the
terms hereof;
|
Β
Β
|
(g)
|
if,
at any time after execution of this Option Agreement, it, or any of its
Affiliates, becomes aware that it or any of its Affiliates, or its or
their employees, agents or subcontractors who participated, or is
participating, in the performance of any activities hereunder is on, or is
being added to the FDA Debarment List or any of the three (3) FDA Clinical
Investigator Restriction Lists referenced in Section 8.3(g), it will
provide written notice of this to Novartis within two (2) Business Days of
its becoming aware of this fact;
and
|
Β
Β
|
(h)
|
it
shall maintain insurance with respect to its activities and obligations
under this Option Agreement in such amounts as are commercially reasonable
in the industry for companies conducting similar business and shall
require any of its Affiliates undertaking any activities under this Option
Agreement to do the same.
|
Β
8.5
|
No Other
Warranties.Β Β EXCEPT AS EXPRESSLY STATED IN SECTIONS 8.1 β
8.4 OR IN EXHIBIT A,
(A)Β NO REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR
GIVEN BY OR ON BEHALF OF NOVARTIS OR QUARK; AND (B)Β ALL OTHER
CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE
ARE HEREBY EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT.
|
Β
8.6
|
Special, Indirect and Other
Losses.Β Β NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE
LIABLE IN CONTRACT, TORT, NEGLIGENCE BREACH OF STATUTORY DUTY OR OTHERWISE
FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR FOR ANY
ECONOMIC LOSS OR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY
[*].
|
Β
8.7
|
No
Exclusion.Β Β Neither Party excludes
[*].
|
Β
[ * ] = 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.
Β
26
Β
9.
|
PUBLICATIONS
AND PUBLICITY
|
Β
9.1
|
Publications.Β If Quark intends
making any public disclosure relating to any Quark Compounds or Products,
including in any scientific journals, publications or scientific
presentations or otherwise, Quark shall provide Novartis with an advance
copy of any such proposed publication or summary of any such proposed oral
presentation prior to its submission for publication or disclosure in
sufficient time to allow Novartis a reasonable opportunity to review and
comment upon such publication or summary.Β Β Quark shall consider
in good faith any such comments from
Novartis.Β Β Β
|
Β
9.2
|
Publicity.
|
Β
Β
|
(a)
|
Neither
Party shall use the name, symbol, trademark, trade name or logo of the
other Party or its Affiliates in any press release, publication or other
form of public disclosure without the prior written consent of the other
Party in each instance (such consent not to be unreasonably withheld or
delayed), except for (i) a press release in the form attached as Exhibit I and
further disclosures of substantially the same information included therein
and (ii) those disclosures for which consent has already been
obtained.
|
Β
Β
|
(b)
|
Except
as permitted under Section 9.2(a), each Party agrees not to issue any
press release or other public statement, whether oral or written,
disclosing the existence of this Option Agreement, the terms hereof or any
information relating to this Option Agreement without the prior written
consent of the other Party.Β Β When seeking the consent of
Novartis, Quark agrees to provide Novartis with at least [*] within which
to grant or withhold its consent.
|
Β
Β
|
(c)
|
Notwithstanding
the foregoing, each Party may make any disclosures required of it to
comply with any duty of disclosure it may have pursuant to law or
governmental regulation or pursuant to the rules of any recognized stock
exchange.Β Β In the event of a disclosure required by law,
governmental regulation or the rules of any recognized stock exchange, the
Parties shall coordinate with each other with respect to the timing, form
and content of such required disclosure.Β Β If so requested by the
other Party, the Party subject to such obligation shall use commercially
reasonable efforts to obtain an order protecting to the maximum extent
possible the confidentiality of such provisions (including, without
limitation, financial terms) of this Option Agreement as reasonably
requested by the other Party.Β Β If the Parties are unable to
agree on the form or content of any required disclosure, such disclosure
shall be limited to the minimum required as determined by the disclosing
Party in consultation with its legal counsel.Β Β Without limiting
the foregoing, each Party shall consult with the other Party on the
provisions of this Option Agreement, together with exhibits or other
attachments attached hereto, to be redacted in any filings made by Quark
or Novartis with the Securities and Exchange Commission (or other
regulatory body) or as otherwise required by
law.
|
Β
[ * ] = 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.
Β
27
Β
10.
|
GENERAL
PROVISIONS
|
Β
10.1
|
Assignment.Β Β Neither
Party may assign its rights and obligations under this Option Agreement
[*], except that Novartis may without the consent of Quark (a) assign it
rights and obligations under this Option Agreement or any part hereof to
one or more of its Affiliates without the consent of Quark provided that
Novartis shall remain primarily liable for any acts or omissions of its
Affiliates under this Option Agreement; and (b) assign this Option
Agreement in its entirety to a successor to all or substantially all of
its business or assets to which this Option Agreement relates, and Quark
may without the consent of Novartis assign this Option Agreement in its
entirety to a successor to all or substantially all of its business or
assets.Β Β The assigning Party shall provide the other Party with
prompt written notice of any such assignment.Β Β Any permitted
assignee shall assume all obligations of its assignor under this Option
Agreement (or related to the assigned portion in case of a partial
assignment to an Affiliate), and no permitted assignment shall relieve the
assignor of liability hereunder.Β Β Any attempted assignment in
contravention of the foregoing shall be void.Β Β Subject to the
terms of this Option Agreement, this Option Agreement shall be binding
upon and inure to the benefit of the Parties hereto and their respective
successors and permitted assigns.
|
Β
10.2
|
Performance by
Affiliates.Β Β Each Party
shall have the right to perform its obligations under this Option
Agreement through one or more of its Affiliates (provided that in the case
of Quark, such Affiliates shall be limited to QBI Enterprises, Ltd., or
any future Affiliates as to which Novartis grants its written
consent).Β Β All applicable terms and provisions of this Option
Agreement shall apply to any such Affiliate that is performing obligations
under this Option Agreement to the same extent as such terms and
provisions apply to such Party.Β Β Each Party shall remain
primarily liable for any acts or omissions of its
Affiliates.
|
Β
10.3
|
Severability.Β Β Should
one or more of the provisions of this Option Agreement become void or
unenforceable as a matter of law, then this Option Agreement shall be
construed as if such provision were not contained herein and the remainder
of this Option Agreement shall be in full force and effect, and the
Parties will use their commercially reasonable efforts to substitute for
the invalid or unenforceable provision a valid and enforceable provision
which conforms as nearly as possible with the original intent of the
Parties.
|
Β
10.4
|
Governing Law and
Jurisdiction.Β Β This Option Agreement shall be governed by
and construed under the laws of [*], without giving effect to the
conflicts of laws provision
thereof.Β Β Subject to Section 10.5, any dispute arising out of or relating to
this Option Agreement shall be subject to the exclusive jurisdiction of
the courts located in [*].
|
Β
10.5
|
Dispute
Resolution.
|
Β
Β
|
(a)
|
In
the event of a dispute under this Option Agreement, either Party may
require that the Parties refer the dispute to the Joint Discussion
Committee for discussion and resolution and decisions to resolve disputes
shall be made by unanimous vote of the Joint Discussion Committee, with
each Partyβs representative having one (1) vote.Β Β If the Parties
are unable, through discussions at the Joint Discussion Committee, to
resolve such a dispute within [*] of the dispute being referred to them,
either Party may require that the Parties forward the matter to the
Senior Officers (or designees with similar authority to resolve such
dispute), who shall attempt in good faith to resolve such
dispute.Β Β If the Senior Officers cannot resolve such dispute
within [*] of the matter being referred to them, either Party shall be
free to initiate the arbitration proceedings outlined in sub-Section (b)
below.
|
Β
[ * ] = 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.
Β
28
Β
Β
|
(b)
|
Any
unresolved disputes between the Parties relating to, arising out of or in
any way connected with this Option Agreement or any term or condition
hereof, or the performance by either Party of its obligations hereunder,
whether before or after termination of this Option Agreement, shall be
resolved by final and binding arbitration.Β Β Whenever a Party
shall decide to institute arbitration proceedings, it shall give written
notice to that effect to the other Party.Β Β Arbitration shall be
held in New York, New York, according to the Rules of Arbitration of the
International Chamber of Commerce (βICCβ).Β Β The
arbitration will be conducted in English by a panel of arbitrators
appointed in accordance with ICC rules; provided that each Party shall
within [*] after the institution of the arbitration proceedings appoint an
arbitrator, and such arbitrators shall together, within [*], select a
third arbitrator as the chairman of the arbitration panel, each arbitrator
shall have significant experience in the pharmaceutical
business.Β Β If the two initial arbitrators are unable to select a
third arbitrator within such [*] period, the third arbitrator shall be
appointed in accordance with ICC rules. Discovery shall be governed by ICC
rules, except that discovery shall be limited to: (i) the production of
documents in the producing Partyβs possession, not otherwise available to
the Party seeking the documents, that are [*] to [*] to the [*]; (ii) [*]
per side of a maximum of [*] (provided, however, that for good cause
shown, the arbitrators may authorize additional [*]); and (iii)Β [*]
per side.Β Β In addition, requests for production of documents
shall contain a description of specific documents or classes of documents,
along with [*].Β Β The arbitrators may condition any exchange of
documents subject to claims of commercial or technical confidentiality on
appropriate measures to protect such confidentiality.Β Β When
documents to be exchanged are maintained in electronic form, the Party in
possession of such documents may make them available in the form (which
may be paper copies) most convenient and economical for it, unless the
arbitrators determine, on application and for good cause, that there is a
compelling need for access to the documents in a different
form.Β Β The Party seeking the production of documents shall
ensure that [*] for [*] are [*] to make [*] as [*].Β Β The
arbitrators shall render their opinion within [*] of the final arbitration
hearing.Β Β No arbitrator (nor the panel of arbitrators) shall
have the power to award punitive damages under this Option Agreement and
such award is expressly prohibited.Β Β Decisions of the panel of
arbitrators shall be final and binding on the Parties.Β Β Judgment
on the award so rendered may be entered in any court of competent
jurisdiction.Β Β The losing Party to the arbitration (if any) as
determined by the arbitrator shall pay the fees and costs of
arbitration.
|
Β
[ * ] = 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.
Β
29
Β
10.6
|
Force
Majeure.Β Β Neither Party shall be responsible to the other
for any failure or delay in performing any of its obligations under this
Option Agreement or for other nonperformance hereunder if such delay or
nonperformance is caused by strike, stoppage of labor, lockout or other
labor trouble, fire, flood, accident, war, act of terrorism, act of God or
of the government of any country or of any local government, or by cause
unavoidable or beyond the control of any Party hereto.Β Β In such
event, the Party affected will use commercially reasonable efforts to
resume performance of its
obligations.
|
Β
10.7
|
Waivers and
Amendments.Β Β The failure of any Party to assert a right
hereunder or to insist upon compliance with any term or condition of this
Option Agreement shall not constitute a waiver of that right or excuse a
similar subsequent failure to perform any such term or condition by the
other Party.Β Β No waiver shall be effective unless it has been
given in writing and signed by the Party giving such waiver.Β Β No
provision of this Option Agreement may be amended or modified other than
by a written document signed by authorized representatives of each
Party.
|
Β
10.8
|
Relationship of the
Parties.Β Β Nothing contained in this Option Agreement
shall be deemed to constitute a partnership, joint venture, or legal
entity of any type between Quark and Novartis, or to constitute one as the
agent of the other.Β Β Each Party shall act solely as an
independent contractor, and nothing in this Option Agreement shall be
construed to give any Party the power or authority to act for, bind, or
commit the other.
|
Β
10.9
|
Notices.Β Β All
notices, consents, waivers, and other communications under this Option
Agreement must be in writing and will be deemed to have been duly given
when: (a)Β delivered by hand (with written confirmation of receipt);
(b)Β sent by fax (with written confirmation of receipt), provided that
a copy is immediately sent by an internationally recognized overnight
delivery service (receipt requested); or (c)Β when received by the
addressee, if sent by an internationally recognized overnight delivery
service (receipt requested), in each case to the appropriate addresses and
fax numbers set forth below (or to such other addresses and fax numbers as
a Party may designate by notice):
|
Β
If to
Quark:
Β
Quark
Pharmaceuticals, Inc.
6500
Xxxxxxxxx Xxxxxx
Xxxxxxx,
XX 00000
X.X.X.
Attn:
Chief Executive Officer
Fax:
(000) 000-0000
Β
With a
copy to:
Β
Xxxxxx
LLP
Five Palo
Alto Square
3000 Xx
Xxxxxx Xxxx
Xxxx
Xxxx, XXΒ Β 00000
U.S.A.
Attention:
Xxxxxx. X. Xxxxx
Fax:
(000) 000-0000
Β
[ * ] = 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.
Β
30
Β
If to
Novartis:
Β
Novartis
International Pharmaceutical Ltd.
130 Xxxxx
Xxxxxx
Xxxxxxxx
Xxxxxxx
XX 00
Attn:
General Counsel
Fax:
[*]
Β
with a
copy to:
Β
Novartis
Pharma AG
Xxxxxxxxxxxx
00
XX - 0000
Xxxxx
Xxxxxxxxxxx
Attn:Β Β General
Counsel
Fax:Β Β [*]
and
Novartis
Pharma AG
Xxxxxxxxxxxx
00
XX - 0000
Xxxxx
Xxxxxxxxxxx
Attn:Β Β Head,
Business Development and Licensing
Fax:
[*]
Β
10.10
|
Further
Assurances.Β Β Novartis and Quark hereby covenant and agree
without the necessity of any further consideration, upon request of the
other Party, to execute, acknowledge and deliver any and all such other
documents and take any such other action as may be reasonably necessary to
carry out the intent and purposes of this Option
Agreement.
|
Β
10.11
|
Compliance with
Law.Β Β Each Party shall perform its obligations under this
Option Agreement in accordance with all applicable laws.Β Β No
Party shall, or shall be required to, undertake any activity under or in
connection with this Option Agreement which violates, or which it
believes, in good faith, may violate, any applicable law.
|
Β
10.12
|
No Third Party Beneficiary
Rights.Β Β Other than
as provided in Section 10.2, the provisions of this Option Agreement are
for the sole benefit of the Parties and their successors and permitted
assigns, and they shall not be construed as conferring any rights to any
Third Party (including any Third Party beneficiary
rights).
|
Β
[ * ] = 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.
Β
31
Β
10.13
|
English
Language.Β Β This Option Agreement is written and executed
in the English language.Β Β Any translation into any other
language shall not be an official version of this Option Agreement and in
the event of any conflict in interpretation between the English version
and such translation, the English version shall
prevail.
|
Β
10.14
|
Expenses.Β Β Except
as otherwise expressly provided in this Option Agreement, each Party shall
pay the fees and expenses of its respective lawyers and other experts and
all other expenses and costs incurred by such Party incidental to the
negotiation, preparation, execution and delivery of this Option
Agreement.
|
Β
10.15
|
Entire
Agreement.Β Β This Option Agreement, together with its
Exhibits, sets forth the entire agreement and understanding of the Parties
as to the subject matter hereof and supersedes all proposals, oral or
written, and all other prior communications between the Parties with
respect to such subject matter.
|
Β
10.16
|
Counterparts.Β Β This
Option Agreement may be executed (a) in one or more partially or fully
executed counterparts, each of which shall be deemed an original and shall
bind the signatory, but all of which together shall constitute the same
instrument, and (b) by facsimile or other electronic means, which
facsimile or other electronic signatures shall be deemed an original and
shall bind the signatory.Β Β The execution and delivery of a
signature page in the form attached to this Option Agreement by any Party
hereto who shall have been furnished the final form of this Option
Agreement shall constitute the execution and delivery of this Option
Agreement by such Party.
|
Β
10.17
|
Cumulative
Remedies.Β Β No remedy referred to in this Option Agreement
is intended to be exclusive, but each shall be cumulative and in addition
to any other remedy referred to in this Option Agreement or otherwise
available under law.
|
Β
IN
WITNESS WHEREOF, the Parties intending to be bound have caused this Option
Agreement to be executed by their duly authorized representatives.
Β
[ * ] = 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.
Β
32
Β
NOVARTIS
INTERNATIONAL
|
Β |
QUARK
PHARMACEUTICALS, INC.
|
||
PHARMACEUTICAL
LIMITED
|
Β | Β | ||
Β | Β | Β | ||
By:
|
/s/
X. X. Xxxx
|
Β |
By:
|
/s/
D. Zurr
|
Name:
|
X.X.
Xxxx
|
Β |
Name:
|
Xxxxxx
Xxxx
|
Title:
|
Director
|
Β |
Title:
|
President
& CEO
|
Β | Β | Β | ||
Date:
|
Β Β | Β |
Date:
|
August
17, 2010
|
Β | Β | Β | ||
By:
|
/s/
Xxxxxx X. Xxxxxxxx
|
Β | Β | |
Name:
|
Xxxxxx
X. Xxxxxxxx
|
Β | Β | |
Title:
|
Director
|
Β | Β | |
Β | Β | Β | ||
Date:
|
August
17th, 2010
|
Β | Β |
Β
[
* ] = 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.
Β
33
Β
Β
EXHIBIT
A
Β
LICENSE
AGREEMENT
Β
[ * ] = 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.
Β
Β
34
Β
Β
Execution
Copy
CONFIDENTIAL
Β
Β
License
Agreement
Β
By
And Between
Β
Novartis
International Pharmaceutical Ltd.
Β
And
Β
Quark
Pharmaceuticals, Inc.
Β
Β
[ * ] = 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.
Β
Β
Β
Β
1.
|
DEFINITIONS
AND INTERPRETATION
|
2
|
Β | Β | Β |
2.
|
LICENSE
|
13
|
Β | Β | Β |
3.
|
GOVERNANCE
|
14
|
Β | Β | Β |
4.
|
DISCLOSURE
OF QUARK KNOW-HOW & COOPERATION
|
16
|
Β | Β | Β |
5.
|
DEVELOPMENT
|
17
|
Β | Β | Β |
6.
|
MANUFACTURING
|
22
|
Β | Β | Β |
7.
|
COMMERCIALIZATION
|
23
|
Β | Β | Β |
8.
|
FINANCIAL
PROVISIONS
|
24
|
Β | Β | Β |
9.
|
REPORTS
AND PAYMENT TERMS
|
36
|
Β | Β | Β |
10.
|
INTELLECTUAL
PROPERTY RIGHTS
|
40
|
Β | Β | Β |
11.
|
CONFIDENTIALITY
|
44
|
Β | Β | Β |
12.
|
TERM
AND TEXXXXXXXXX
|
00
|
Β | Β | Β |
00.
|
EFFECT
OF TERMINATION
|
48
|
Β | Β | Β |
14.
|
REPRESENTATIONS,
WARRANTIES AND COVENANTS
|
51
|
Β | Β | Β |
15.
|
INDEMNIFICATION;
LIABILITY
|
55
|
Β | Β | Β |
16.
|
PUBLICATIONS
AND PUBLICITY
|
57
|
Β | Β | Β |
17.
|
GENERAL
PROVISIONS
|
59
|
Β
[ * ] = 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.
Β
Β
Β
Β
LICENSE
AGREEMENT
Β
This
LICENSE AGREEMENT (βAgreementβ) is made as of this
__ day of ________, 20__ (βExecution Dateβ), by and
between Novartis International Pharmaceutical Ltd., a limited company organized
and existing under the laws of Bermuda (βNovartisβ) and Quark
Pharmaceuticals, Inc., a corporation company organized and existing under the
laws of California, U.S.A. (βQuarkβ).Β Β Novartis
and Quark are each referred to individually as a βPartyβ and together as the
βParties.β
Β
RECITALS
Β
WHEREAS,
Quark owns or controls the Quark Patents and Quark Know-How (each as defined
below) relating to the Quark Compounds (as defined below);
Β
WHEREAS,
the Parties entered into an Option Agreement dated August 17, 2010 (βOption Agreementβ) under which
Quark granted Novartis an Option (as defined in the Option Agreement) to obtain
rights to the Quark Compounds in the Field (as defined below);
Β
WHEREAS,
Novartis has exercised the Option; and
Β
WHEREAS,
Novartis now has the right to develop and commercialize Products (as defined
below) on a worldwide basis in the Field, subject to paying Quark the royalty
and milestone payments set out herein.
Β
NOW,
THEREFORE, in consideration of the mutual covenants and agreements herein
contained, the Parties agree as follows.
Β
1.Β Β Β Β Β Β Β Β Β DEFINITIONS
AND INTERPRETATION
Β
Β
|
1.1
|
Definitions.Β Β Unless
the context otherwise requires, the terms in this Agreement with initial
letters capitalized, shall have the meanings set forth below, or the
meaning as designated in the indicated places throughout this
Agreement.
|
Β
βAccounting Standardsβ means,
with respect to Quark, US GAAP (United States Generally Accepted Accounting
Principles) and means, with respect to Novartis, the IFRS (International
Financial Reporting Standards), in each case, as generally and consistently
applied throughout the Partyβs organization.
Β
[ * ] = 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.
Β
Β
2
Β
Β
βAffiliateβ means, with
respect to a Party, any Person that controls, is controlled by, or is under
common control with that Party.Β Β For the purpose of this definition,
βcontrolβ shall mean, direct or indirect, ownership of fifty percent (50%) or
more of the shares of stock entitled to vote for the election of directors, in
the case of a corporation, or fifty percent (50%) or more of the equity interest
in the case of any other type of legal entity, status as a general partner in
any partnership, or any other arrangement whereby the entity or person controls
or has the right to control the board of directors or equivalent governing body
of a corporation or other entity, or the ability to cause the direction of the
management or policies of a corporation or other entity.Β Β In the case
of entities organized under the laws of certain countries, the maximum
percentage ownership permitted by law for a foreign investor may be less than
fifty percent (50%), and in such case such lower percentage shall be substituted
in the preceding sentence, provided that such
foreign investor has the power to direct the management and policies of such
entity.
Β
βAKI Final Reportβ has the
meaning set forth in the Option Agreement.
Β
βAKI First Interpretable
Resultsβ has the meaning set forth in the Option Agreement.
Β
βAKI Indicationβ means the
treatment and/or prevention of acute kidney injury following cardiac
surgery.
Β
βAKI Phase II Trialβ has the
meaning set forth in the Option Agreement.
Β
βAKI Phase II Trial Protocolβ
has the meaning set forth in the Option Agreement; provided that,
following the License Effective Date, any changes to the AKI Phase II Trial
Protocol (as it exists at the License Effective Date) must be mutually agreed
between the Parties.
Β
βAKI Phase II Trial [*]
Criteriaβ has the meaning set forth in the Option Agreement.
Β
βAlliance Managerβ shall have
the meaning set forth in Section 3.1.
Β
βAlnylam Licenseβ means each
(or, as the context requires, both) of the two (2) License Agreements between
Quark and Alnylam Pharmaceuticals, Inc., both dated September 26,
2006.
Β
βBusiness Dayβ means any day
other than a Saturday, a Sunday or a day on which commercial banks located in
Basel, Switzerland, Xxxxxxxx, Bermuda or California, USA, are authorized or
required by law to remain closed.
Β
βCalendar Quarterβ means the
respective periods of three (3) consecutive calendar months ending on March 31,
June 30, September 30 and December 31.
Β
βCalendar Yearβ means a period
of twelve (12) consecutive calendar months ending on December 31.
Β
βcGCPβ has the meaning set
forth in the Option Agreement.
Β
βcGLPβ has the meaning set
forth in the Option Agreement.
Β
βcGMPβ has the meaning set
forth in the Option Agreement.
Β
[ * ] = 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.
Β
Β
3
Β
Β
βChange of Controlβ means any
of the following events with respect to either Party: (a)Β any Third Party
(or group of Third Parties acting in concert) becomes the beneficial owner,
directly or indirectly, of more than fifty percent (50%) of the total voting
power of the stock then outstanding of such Party normally entitled to vote in
elections of directors; (b)Β such Party consolidates with or merges into
another corporation or entity, or any corporation or entity consolidates with or
merges into such Party, in either event pursuant to a transaction in which more
than fifty percent (50%) of the total voting power of the stock outstanding of
the surviving entity normally entitled to vote in elections of directors is not
held by the parties holding at least fifty percent (50%) of the outstanding
shares of such Party preceding such consolidation or merger; or (c)Β such
Party conveys, transfers or leases all or substantially all of its assets to any
Third Party.
Β
βClaimsβ means all Third Party
demands, claims, actions, proceedings and liability (whether criminal or civil,
in contract, tort or otherwise) for losses, damages, reasonable legal costs and
other reasonable expenses of any nature whatsoever.
Β
βCombination Productsβ mean
any pharmaceutical product (in any formulation) containing one or more active
pharmaceutical ingredients in addition to the Quark Compound.
Β
βCommencement of First Phase III
Clinical Trialβ means with respect to any indication, the first dosing of
the first patient with Product in the first Phase III Clinical Trial of the
first Product to be developed for such indication.
Β
βCommercializeβ means to
market, promote, distribute, import, export, offer to sell and/or sell Product
and/or conduct other Commercialization, and βCommercializationβ means
commercialization activities relating to Product, including activities relating
to marketing, promoting, distributing, importing, exporting, offering for sale
and/or selling Product.
Β
βCommercially Reasonable
Effortsβ means the expenditure of those efforts and resources used [*]
pursuing the development or commercialization of [*], orΒ Β where [*]
does not [*], the expenditure of such efforts and use of such resources
[*].Β Β For clarity, βCommercially Reasonable Effortsβ shall be [*],
accordingly, [*] with respect to [*] may [*] with respect to [*].
Β
βCompeting Productβ means any
product, other than any Product, comprising or including [*].
Β
βConfidential Informationβ
means all Know-How and other proprietary information and data of a financial,
commercial or technical nature which the disclosing Party or any of its
Affiliates has supplied or otherwise made available to the other Party or its
Affiliates, whether made available orally, in writing or in electronic form,
including information comprising or relating to concepts, discoveries,
inventions, data, designs or formulae in relation to this
Agreement.
Β
[ * ] = 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.
Β
Β
4
Β
Β
βControlβ or βControlledβ means, with
respect to any Know How, Patent Rights, other intellectual property rights, or
any proprietary or trade secret information, the legal authority or right
(whether by ownership, license or otherwise) of a Party to grant a license or a
sublicense of or under such Know How, Patent Rights, or intellectual property
rights to another Person, or to otherwise disclose such proprietary or trade
secret information to another Person, without breaching the terms of any
agreement with a Third Party, or misappropriating the proprietary or trade
secret information of a Third Party.
Β
βDevelopβ or βDevelopmentβ means drug
development activities, including, without limitation, test method development
and stability testing, assay development and audit development, toxicology,
formulation, quality assurance/quality control development, statistical
analysis, clinical studies, packaging development, regulatory affairs, and the
preparation, filing and prosecution of NDAs and XXXx.
Β
βDevelopment Costsβ has the
meaning set forth in the Option Agreement.
Β
βDGF DMC Top Line Interim
Reportβ has the meaning set forth in the Option Agreement.
Β
βDGF Final Reportβ has the
meaning set forth in the Option Agreement.
Β
βDGF Indicationβ means the
treatment and/or prevention of delayed graft function following renal
transplantation.
Β
βDGF Phase II Trialβ has the
meaning set forth in the Option Agreement.
Β
βDGF Phase II Trial Protocolβ
has the meaning set forth in the Option Agreement; provided that,
following the License Effective Date, any changes to the DGF Phase II Trial
Protocol (as it exists at the License Effective Date) must be mutually agreed
between the Parties.
Β
βDGF Phase II Trial [*]
Criteriaβ has the meaning set forth in the Option Agreement.
Β
βDGF [*] Reportβ has the
meaning set forth in the Option Agreement.
Β
βDharmacon Licenseβ means the
Patent License Agreement between Quark and Dharmacon, Inc., dated January 29,
2010.
Β
βEMAβ means the European
Medicines Agency or any successor entity thereto.
Β
βEncumbranceβ means any claim,
charge, equitable interest, hypothecation, lien, mortgage, pledge, option,
license, assignment, power of sale, retention of title, right of pre-emption,
right of first refusal or security interest of any kind.
Β
βEU Regulatory Approvalβ means
(a) marketing authorization approval from the EMA and pricing and reimbursement
approval [*] or (b) marketing authorization approval and pricing and
reimbursement approval [*].
Β
[ * ] = 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.
Β
Β
5
Β
Β
βExecution Dateβ shall have
the meaning set forth in the first paragraph of this Agreement.
Β
βFDAβ means the United States
Food and Drug Administration or any successor entity thereto.
Β
βFieldβ means the, diagnosis,
prevention or treatment of diseases and other conditions in all indications in
humans and animals.
Β
βFirst Commercial Saleβ means,
with respect to any Product, the first armβs length sale to a Third Party for
use or consumption of any such Product in a country.
Β
βFTE Rateβ means a rate of [*]
US Dollars ($[*]) per Calendar Year based on the yearly time for a full-time
equivalent scientific person year (consisting of a total of [*] hours per
Calendar Year) of work, to be pro-rated on a daily basis if necessary (per
Calendar Year amount to be divided by [*] to produce the rate per whole day
consisting of eight (8) hours); such rate to [*] and [*]. For the avoidance of
doubt, such rate includes [*] for which [*].Β Β The FTE Rate shall be
[*] from the Option Agreement Effective Date.
Β
βFully-Burdened Manufacturing
Costβ of Novartis means the cost of all resources and any and all
operations (including packaging for shipment) carried out by or on behalf of
Novartis or its Affiliates or subcontractors in order to manufacture and supply
the Quark Compound and/or Product, established in accordance with Novartisβ
accounting procedures and Accounting Standards as consistently applied by
Novartis.
Β
βHSR Actβ means the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules
promulgated thereunder.
Β
βHSR Filing Dateβ has the
meaning set forth in the Option Agreement.
Β
βINDβ means an Investigational
New Drug application in the US filed with the FDA or the corresponding
application for the investigation of Products in any other country or group of
countries, as defined in the applicable laws and regulations and filed with the
Regulatory Authority of a given country or group of countries.
Β
βInsolvency Eventβ means, in
relation to either Party, any one of the following: (a)Β that Party becomes
insolvent; (b)Β that Party is the subject of voluntary or involuntary
bankruptcy proceedings instituted on behalf of or against such Party (except for
involuntary bankruptcy proceedings which are dismissed within [*]); (c)Β an
administrative receiver, receiver and manager, interim receiver, custodian,
sequestrator or similar officer is appointed in respect of that Party;
(d)Β a notice shall have been issued to convene a meeting for the purpose of
passing a resolution to wind up that Party, or such a resolution shall have been
passed other than a resolution for the solvent reconstruction or reorganization
of that Party; or (e)Β a resolution shall have been passed by that Party or
that Partyβs directors to make an application for an administration order or to
appoint an administrator or (f) that Party suspends or threatens to suspend
making payments (excluding payments subject to good faith dispute) to all or
some of that Partyβs creditors or makes a general assignment, composition or
arrangement with or for the benefit of all or the majority of that Partyβs
creditors.
Β
[ * ] = 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.
Β
Β
6
Β
Β
βJoint Know-Howβ means any
Know-How which is jointly owned by Quark (or any of its Affiliates) and Novartis
(or any of its Affiliates) as of the Execution Date or thereafter during the
Term of this Agreement.
Β
βJoint Patentsβ means any
Patent Rights which are jointly owned by Quark (or any of its Affiliates) and
Novartis (or any of its Affiliates) as of the Execution Date or thereafter
during the Term of this Agreement.
Β
βJoint Steering CommitteeβΒ or βJSCβ means the committee
established as set forth inΒ Section
3.2.
Β
βJoint Technologyβ means the
Joint Know-How and Joint Patents.
Β
βKnow-Howβ means all technical
information, know-how and data, including inventions (whether patentable or
not), discoveries, trade secrets, specifications, instructions, processes,
formulae, materials, expertise and other technology applicable to compounds,
formulations, compositions, products or to their manufacture, development,
registration, use or commercialization or methods of assaying or testing them or
processes for their manufacture, formulations containing them, compositions
incorporating or comprising them and including all biological, chemical,
pharmacological, biochemical, toxicological, pharmaceutical, physical and
analytical, safety, quality control, manufacturing, preclinical and clinical
data, instructions, processes, formulae, expertise and information, regulatory
filings and copies thereof, relevant to the development, manufacture, use or
commercialization of and/or which may be useful in studying, testing,
development, production or formulation of products, or intermediates for the
synthesis thereof.
Β
βLicense Effective Dateβ has
the meaning set forth in the Option Agreement.
Β
βLoss of Market Exclusivityβ
means, with respect to any Product in any country, the following has occurred:
(a) a Third Party Competitive Product is being marketed or sold in such country
by a Third Party; and (b) the [*] of such Product in [*] in any [*] are [*]Β of
the [*] of such Product in [*] in the [*] of such Third Party Competitive
Product.
Β
βMAAβ means an application for
the authorization to market a Product in any country or group of countries
outside the United States, as defined in the applicable laws and regulations and
filed with the Regulatory Authority of a given country or group of
countries.
Β
βMajor Marketsβ means the
[*].
Β
βMilestonesβ means the
milestones relating to the Products as set forth in Section 8.4.
Β
βMilestone Paymentsβ means the
payments to be made by Novartis to Quark upon the achievement of the
corresponding Milestones as set forth in Section 8.4.
Β
[ * ] = 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.
Β
Β
7
Β
Β
βNDAβ means a New Drug
Application in the United States for authorization to market a Product, as
defined in the applicable laws and regulations and filed with the
FDA.
Β
βNet Salesβ means the net
sales recorded by Novartis or any of its Affiliates or sublicensees (other than
distributors or wholesalers) for Product sold to Third Parties other than
sublicensees in bona fide, arms-length transactions, [*], less
[*].Β Β The deductions [*] by Novartis and its Affiliates [*] to
calculate the recorded net sales from gross sales shall be as
follows:
Β |
(i)Β
|
[*];
|
Β |
(ii)Β
|
[*];
|
Β |
(iii)Β
|
[*];
|
Β |
(iv)Β
|
[*];
|
Β |
(v)Β
|
[*];
|
Β |
(vi)Β
|
[*];
|
Β |
(vii)
|
[*];
and
|
Β |
(viii)
|
[*].
|
Β
With
respect to the calculation of Net Sales:
Β
Β
|
(i)
|
Net
Sales only include [*] and [*] shall be disregarded for purposes of
calculating Net Sales;
|
Β
Β
|
(ii)
|
If
a Product is delivered to a Third Party before being invoiced (or is not
invoiced), Net Sales will be calculated at [*];
and
|
Β
Β |
(iii)
|
In
the event the Product is sold as a Combination Product, Net Sales of the
Product will be calculated by [*].Β Β Regarding [*], if these are
available for [*]. If the
[*].
|
Β
β[*] Patentsβ has the meaning
set forth in Section 10.2(d).
Β
βOptionβ has the meaning set
forth in the Option Agreement.
Β
βOption Agreementβ has the
meaning set forth in the recitals.
Β
βOut-of-Pocket Costsβ means
direct project related expenses paid or payable to Third Parties and
specifically identifiable and incurred to procure supplies of the Product in the
Territory;Β Β such expenses to have been recorded [*] in accordance with
the Quarkβs Accounting Standards and for the avoidance of doubt,
[*].
Β
βp-53-directed siRNAβ means
any small interfering RNA molecule which interferes with the expression of the
p53 gene in humans or animals [*].
Β
βPatent Rightsβ means all
patents and patent applications, including all divisionals, continuations,
substitutions, continuations-in-part, re-examinations, reissues, additions,
renewals, extensions, registrations, and supplemental protection certificates
and the like of any of the foregoing.
Β
[ * ] = 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.
Β
Β
8
Β
Β
βPersonβΒ means any individual,
partnership, limited liability company, firm, corporation, association, trust,
unincorporated organization or other entity.
Β
βPhase II Clinical Trialβ
means a controlled clinical study of a Product in patients designed to establish
the dosing range for such Product and the safety and efficacy of such
Product.
Β
βPhase II Trial Reportsβ has
the meaning set forth in the Option Agreement.
Β
βPhase II/III Adaptive Design
Clinical Study means for the purpose of Section [*]Β a clinical trial which
combines Phase II and Phase III data into one single confirmatory clinical
trial, where the selected dose is well established and further investigations in
Phase II are performed in the same patient population and the same endpoints as
are relevant in Phase III. The study design consists of two stages. The first
stage aims [*] (learning stage corresponding to Phase II). An interim analysis
is performed at the end of the first stage to select the most suited treatment
for the second stage aimed at [*] selected at such interim analysis [*]
(confirmatory stage corresponding to Phase III).
Β
Β βPhase III Clinical
Trialβ means a pivotal clinical study of a Product in patients designed
to establish efficacy and safety of such Product for the purpose of preparing
and submitting a filing for NDA approval in the US or EU Regulatory
Approval.Β Β Phase III Clinical Trial also includes any Phase II
Clinical Trial that is extended with the intent of establishing efficacy and
safety of a Product for the purpose of preparing and submitting a filing for NDA
approval in the US or EU Regulatory Approval.
Β
Β βProductβ means a
product developed under this Agreement incorporating or comprising one or more
Quark Compounds in finished dosage pharmaceutical form, including, in each case,
all formulations and modes of administration thereof, the manufacture, use,
Development or Commercialization of which: (a)Β would, but for the license
granted hereunder, infringe a Valid Claim; or (b)Β incorporates or embodies
Quark Know-How or Joint Know-How.
Β
βQuark Compoundsβ means all
p53-directed siRNA owned or controlled by Quark, [*].
Β
βQuark Development Planβ has
the meaning set forth in the Option Agreement; provided that,
following the License Effective Date, any changes to the Quark Development Plan
(as it exists at the License Effective Date) [*].
Β
βQuark Know-Howβ means any
Know-How owned (whether solely or jointly with any Third Party) or Controlled by
Quark or any of its Affiliates as of the Execution Date or thereafter during the
term of this Agreement relating to the Quark Compounds and/or Product that is
reasonably necessary or useful for the research, Development, manufacture,
preparation, use or Commercialization of the Quark Compounds and/or Product in
the Field.Β Β For the avoidance of doubt, βQuark Know-Howβ shall not
include any Joint Know-How.
Β
[ * ] = 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.
Β
Β
9
Β
Β
βQuark Patentsβ means the
Patent Rights identified in Exhibit A, and, any
other Patent Rights owned (whether solely or jointly with any Third Party) or
Controlled by Quark or any of its Affiliates as of the Execution Date or
thereafter during the Term of this Agreement having claims covering the Quark
Compounds and/or Product, their use, composition, formulation, preparation or
manufacture or having claims that are reasonably necessary or useful for the
research, Development, manufacture, preparation, use or Commercialization of the
Quark Compounds and/or Product in the Field.Β Β For the avoidance of
doubt, βQuark Patentsβ shall not include any Joint Patents or any [*]
Patents.
Β
βQuark Technologyβ means the
Quark Know-How and Quark Patents.
Β
βRegulatory ApprovalβΒ means, with respect to a
Product in any country or jurisdiction, any approval (including where required,
pricing and reimbursement approvals), registration, license or authorization
from a Regulatory Authority in a country or other jurisdiction that is necessary
to market and sell such Product in such country or jurisdiction.
Β
βRegulatory Authorityβ means
any governmental agency or authority responsible for granting Regulatory
Approvals for Products, including the FDA, EMA and any corresponding national or
regional regulatory authorities.
Β
βRegulatory Exclusivityβ
means, with respect a given country in the Territory, any regulatoryΒ exclusivity, beyond
patent rights, granted by a Regulatory Authority in such country, which confers
an exclusive Commercialization period during which: (i) Novartis has the
exclusive right to market, price and sell a Product in such country through a
regulatory exclusivity right such as a new chemical entity exclusivity, new use
or indication exclusivity, new formulation exclusivity, orphan drug exclusivity
and pediatric exclusivity, or any equivalent of the foregoing; and (ii) no Third
Party Competitive Product is marketed in any such country by any Third
Party.
Β
βRegulatory Filingsβ means,
with respect to the Quark Compounds or Product, any submission to a Regulatory
Authority of any appropriate regulatory application, and shall include, without
limitation, any submission to a regulatory advisory board, marketing
authorization application, and any supplement or amendment
thereto.Β Β For the avoidance of doubt, Regulatory Filings shall include
any IND, NDA or the corresponding application in any other country or group of
countries.
Β
βSales & Royalty Reportβ
means a written report or reports, substantially in the form attached at
Exhibit B,
showing each of: (a)Β the Net Sales in US dollars of each Product in the
Territory [*] during the reporting period by Novartis and its Affiliates and
sublicensees; and (b)Β the royalties payable, in United States Dollars,
which shall have accrued hereunder with respect to such Net Sales.
Β
βSenior Officersβ means, for
Quark, its Chief Executive Officer, and for Novartis:
Β
Β
|
(a)
|
[*]
related to JSC decisions regarding Commercialization issues, the Global
Head of Marketing and Sales, General Medicines, for Novartis Pharma
AG;
|
Β
[ * ] = 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.
Β
Β
10
Β
Β
Β
|
(b)
|
[*]
related to JSC decisions regarding Development issues, the Global Head of
Development for Novartis Pharma AG;
|
Β
Β
|
(c)
|
[*]
related to JSC decisions regarding alliance management issues, the Global
Head of Business Development and Licensing for Novartis Pharma AG;
and
|
Β
Β
|
(d)
|
with
respect to any other matter, including any dispute under Section 17.5, the
Global Head of Business and Development and Licensing for Novartis Pharma
AG.
|
Β
βSilence Licenseβ means the
Option and License Agreement between Quark and Silence Therapeutics AG (formerly
known as Atugen AG), dated April 19, 2005.
Β
βTerritoryβ means worldwide,
subject to Quarkβs rights in Israel described Sections 5.4 and 7.2
below.
Β
βThird Partyβ means any Person
other than a Party or an Affiliate of a Party.
Β
βThird Party Competitive Productβ
means, with respect to any Product being commercialized by or on behalf
of Novartis in a particular country in the Field, any preparation in final form
being commercialized by a Third Party (other than a sublicensee of Novartis [*]
in such country in the Field, which contains either:
Β
Β
|
(a)
|
any
[*]; or
|
Β
Β
|
(b)
|
any
compound which is [*] to [*], where the [*] is [*] a [*] under [*], and
[*].
|
Β
βThird Qualifying Indicationβ
means the first indication, other than the AKI Indication and the DGF
Indication, for which the Product is developed and for which Novartis has, in
good faith, [*].
Β
βTransition Planβ has the
meaning set forth in Section 4.2.
Β
βTrial [*] Criteriaβ means the
AKI Phase II Trial [*] Criteria and/or the DGF Phase II Trial [*] Criteria, each
as defined in the Option Agreement.
Β
βUIC Licenseβ means the Option
and License Agreement between Quark and the Board of Trustees of the University
of Illinois, dated September 3, 1999.
Β
βUnited StatesβΒ or βUSβ means the United States of
America, its territories and possessions.
Β
βUSDβ or βUS$β means the lawful
currency of the United States.
Β
βUS Regulatory Approvalβ means
final Regulatory Approval from the FDA and, if applicable, pricing and
reimbursement approval in the US.
Β
[ * ] = 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.
Β
Β
11
Β
Β
βValid Claimβ means, with
respect to any country, a claim of: (i) an issued patent included within the
Quark Patents or Joint Patents in such country, which has not expired or been
revoked, or held invalid or unenforceable by a patent office, court or other
governmental agency of competent jurisdiction in a final and non-appealable
judgment (or judgment from which no appeal was taken within the allowable time
period), and which has not been admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise; and (ii) a patent application within the Quark
Patents (not including any Joint Patents) which is being prosecuted in good
faith, which has not been revoked, cancelled, withdrawn, held invalid or
abandoned, and which has not been pending for more than [*] from its first
priority filing date.
Β
1.2
|
Interpretation.Β Β In
this agreement unless otherwise
specified:
|
Β
Β
|
(a)
|
βincludesβ
and βincludingβ shall mean respectively includes and including without
limitation;
|
Β
Β
|
(b)
|
a
Party includes its permitted assignees and/or the respective successors in
title to substantially the whole of its undertaking, subject to the
provisions of Sections 3.6 and
17.1;
|
Β
Β
|
(c)
|
a
statute or statutory instrument or any of their provisions is to be
construed as a reference to that statute or statutory instrument or such
provision as the same may have been or may from time to time hereafter be
amended or re-enacted;
|
Β
Β
|
(d)
|
words
denoting the singular shall include the plural and vice versa and words
denoting any gender shall include all
genders;
|
Β
Β
|
(e)
|
the
Exhibits and other attachments form part of the operative provision of
this Agreement and references to this Agreement shall, unless the context
otherwise requires, include references to the Exhibits and
attachments;
|
Β
Β
|
(f)
|
the
headings in this Agreement are for information only and shall not be
considered in the interpretation of this
Agreement;
|
Β
Β
|
(g)
|
general
words shall not be given a restrictive interpretation by reason of their
being preceded or followed by words indicating a particular class of acts,
matters or things; and
|
Β
Β
|
(h)
|
the
Parties agree that the terms and conditions of this Agreement are the
result of negotiations between the Parties and that this Agreement shall
not be construed in favor of or against any Party by reason of the extent
to which any Party participated in the preparation of this
Agreement.
|
Β
[ * ] = 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.
Β
Β
12
Β
Β
2.
|
LICENSE
|
Β
2.1
|
License Grant. Subject
to the terms and conditions of this Agreement, Quark hereby grants to
Novartis an exclusive (even as to Quark), sub-licensable (pursuant to
Section 2.2) license, under the Quark Technology and Quarkβs interest in
any Joint Technology to research, Develop, make, use, import, offer for
sale, sell and otherwise Commercialize, or to have any of the foregoing
done on its behalf, the Quark Compounds and Product in the Field in the
Territory, subject to Quarkβs retained rights in Israel as set forth in
Section 5.4 and 7.2 below. For the avoidance of doubt, the foregoing
license is exclusive to Novartis and Quark has no retained rights (and
will not attempt to license any rights, directly or indirectly, to any
Third Party) with respect to the Quark Compounds and Products in the Field
in the Territory; except for activities undertaken pursuant to the terms
of this Agreement. For further clarity, Quark retains all the rights in
Quark Technology and Quarkβs interest in any Joint Technology outside the
scope of the foregoing license. Exhibit A separately identifies those
Quark Patents that also have utility outside of such foregoing license.
Novartis acknowledges that Quarkβs licenses under the Silence License and
the Alnylam License are non-exclusive, and accordingly, that Novartisβ
licenses under this Section 2.1 with respect to these two upstream
licenses are non-exclusive.
|
Β
2.2
|
Sublicense and Subcontract
Rights.
|
Β
Β
|
(a)
|
Novartis
may exercise its rights and perform its obligations under this Agreement
itself or through any of its Affiliates; provided that
Novartis shall remain primarily liable for any acts or omissions of its
Affiliates.
|
Β
Β
|
(b)
|
Novartis
may sublicense the rights granted to it by Quark under this Agreement to
one or more Third Parties at any time at its sole discretion and without
reference to Quark, provided that such sublicense shall comply with all
applicable provision of this Agreement and [*].Β Β In addition,
Novartis may subcontract to Third Parties the performance of tasks and
obligations with respect to the Development, manufacture and
Commercialization of Products as Novartis deems
appropriate.Β Β Novartis shall be responsible for the performance
of its sublicensees and
subcontractors.
|
Β
2.3
|
Exclusivity.
|
Β
Β
|
(a)
|
During
the term of the Agreement, neither Quark nor any of its Affiliates will,
directly or indirectly: (i)Β license, assign or otherwise dispose of
any of its rights (also by way of granting an option similar to the
Option) in the Quark Compounds, Product or p53-specific Quark Technology
to any Third Party; (ii)Β enter into any collaboration or license
agreement with any Third Party in connection with the development and/or
commercialization of any Quark Compound, Product or Competing Product; or
(iii) research (except as provided in the last sentence of this Section
2.3(a)) Develop, manufacture or Commercialize any Quark Compound, Product
or Competing Product.Β Β Notwithstanding any other provision
hereof, this Section shall not apply to activities conducted by Quark or
its Affiliates pursuant to and in accordance with this Agreement.Β Β For clarity, this
Section 2.3(a) shall not prevent Quark from performing [*] research
relating to a Quark Compound, Product or Competing Product, provided that
[*].
|
Β
[ * ] = 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.
Β
Β
13
Β
Β
Β
|
(b)
|
For
the period from the License Effective Date until [*] after [*] in [*],
neither [*] nor any [*] will, directly or indirectly, [*], other than for
[*] in [*] in [*].
|
Β
3.
|
GOVERNANCE
|
Β
3.1
|
Alliance
Managers.Β Β Within [*] following the License Effective
Date, each Party will appoint (and notify the other Party of the identity
of) a senior representative having a general understanding of
pharmaceutical development and commercialization issues to act as its
alliance manager under this Agreement (βAlliance
Managerβ).Β Β The Alliance Managers will serve as the
contact point between the Parties for the purpose of providing Quark with
information on the progress of Novartisβ Development and Commercialization
of the Product(s) and will be primarily responsible for facilitating the
flow of information and otherwise promoting communication, coordination
and collaboration between the Parties; providing single point
communication for seeking consensus both internally within the respective
Partyβs organization and together regarding key global strategy and
planning issues, as appropriate, including facilitating review of external
corporate communications; and raising cross-Party and/or cross-functional
disputes in a timely manner.Β Β Each Party may replace its
Alliance Manager on written notice to the other
Party.
|
Β
3.2
|
Joint Steering
Committee.
|
Β
Β
|
(a)
|
The
Parties will establish a Joint Steering Committee, composed of [*] senior
personnel of Quark and [*] senior personnel of Novartis (one (1) of which
will be the Partyβs Alliance Manager and which personnel for each Party,
collectively, shall have a general understanding of drug manufacturing,
development and commercialization
issues).
|
Β
Β
|
(b)
|
Within
[*] following the License Effective Date, each Party will designate its
initial members to serve on the JSC and notify the other Party of the
dates of availability for the first meeting of the JSC.Β Β Each
Party may replace its representatives on the JSC on written notice to the
other Party.
|
Β
Β
|
(c)
|
The
JSC will:Β Β (i)Β oversee the Know-How and technology
transfers contemplated in Sections 4.1, 4.2, 4.5 and 6.2 of this
Agreement; (ii) review and discuss Development activities with respect to
the Quark Compounds and the Product, including any activities of Quark in
Israel under Section 5.4; (iii)Β discuss and approve the clinical
trial protocols for the Product (other than the DGF Phase II Trial
Protocol and the AKI Phase II Trial Protocol), including any material
revisions thereto, in each indication; (iv) review and discuss Novartisβ
Commercialization strategies with respect to the Product, and, in the
event that Quark distributes Products in Israel pursuant to Section 7.2,
oversee such distribution activities; and (v)Β consider and act upon
such other matters as specified in this
Agreement.
|
Β
[ * ] = 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.
Β
Β
14
Β
Β
Β
|
(d)
|
The
JSC also may, at any time it deems necessary or appropriate, establish
additional joint committees and delegate such of its responsibilities as
it determines appropriate to such joint
committees.
|
Β
3.3
|
Meetings of the Joint Steering
Committee.
|
Β
Β
|
(a)
|
The
JSC shall meet [*] per Calendar Year and at such other times as the
Parties may agree.Β Β The first meeting of the JSC shall be held
as soon as reasonably practicable, but in no event later than [*]
following the License Effective Date.Β Β Meetings shall be held at
such place or places as are mutually agreed or by teleconference or
videoconference; provided, however, that
there shall be at least one face-to-face meeting per Calendar Year, unless
the Parties otherwise agree.
|
Β
Β
|
(b)
|
Each
Party may from time to time invite a reasonable number of participants, in
addition to its representatives, to attend JSC meetings in a non-voting
capacity, with the consent of the other Party (which shall not be
unreasonably withheld); provided, that
that if Quark intends to have any Third Party (including any consultant)
attend such a meeting, such Third Party will be subject to the prior
approval of Novartis and must be bound by confidentiality obligations
consistent with the terms of this
Agreement.
|
Β
Β
|
(c)
|
Novartis
shall appoint one of its representatives on the JSC to act as chairperson
of the JSC.Β Β The chairperson shall set agendas for JSC meetings,
provided
that the agendas will include any matter requested by either
Party.Β Β The chairperson shall be responsible for recording,
preparing and, within a reasonable time, issuing (i) draft minutes of each
JSC meeting, which draft minutes shall be subject to review and approval
by all JSC members, and (ii) final minutes following such
approval.
|
Β
3.4
|
Decision Making.
Decisions of the JSC shall be made by unanimous vote, with each
Partyβs representatives to the JSC collectively having one
vote.Β Β In the event of a disagreement among the JSC with respect
to any matter other than a matter related to [*], Novartis shall have a
casting vote; provided, however, that,
in the event that Novartis exercises such casting vote with respect to any
issue which is [*], and in the event that Quark objects to such decision,
Quark may, by notice in writing within [*] of Novartisβ exercise of its
casting vote, refer the matter to the Senior Officers who shall attempt in
good faith to resolve such disagreement.Β Β If they cannot resolve
such issue within [*] of the matter being referred to them, then the
resolution and/or course of conduct shall be determined by
[*].Β Β However, in no event shall [*] have the
right:
|
Β
Β
|
(a)
|
to
modify or amend the terms and conditions of this Agreement;
or
|
Β
Β
|
(b)
|
to
determine any such issue in a manner that would conflict with the express
terms and conditions of this Agreement;
or
|
Β
Β
|
(c)
|
to
increase the performance obligations of [*] beyond those set forth
herein.
|
Β
[ * ] = 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.
Β
Β
15
Β
Β
3.5
|
Costs of
Governance.Β Β The Parties agree that the costs incurred by
each Party in connection with its participation at any meetings under this
Article 3 shall be borne solely by such
Party.
|
Β
3.6
|
Change of
Control.Β Β In the event of a Change of Control of Quark,
Novartis may provide written notice to Quark (or its successor entity) to
[*] and upon such notice, [*] shall be [*], and [*] shall thereafter be
[*].
|
Β
3.7
|
Discontinuance of JSC
Participation.Β Β Quark shall have the right to discontinue
its participation in the JSC upon written notice to Novartis at any time
during the Term.Β Β Once Quark has provided written notice to
discontinue its participation in the JSC, [*] shall be deleted from this
Agreement, and any decisions otherwise assigned to the JSC shall
thereafter be [*].
|
Β
4.
|
DISCLOSURE
OF QUARK KNOW-HOW & COOPERATION
|
Β
4.1
|
Disclosure of Quark
Know-How.Β Β Following the License Effective Date, Quark
shall disclose the Quark Know-How to Novartis in accordance with Section
4.3 of the Option Agreement (without regard to the termination of the
Option Agreement).Β Β Thereafter, on a continuing basis during the
term of this Agreement, Quark, without additional consideration [*], shall
disclose to Novartis or its designated Affiliate all additional Quark
Know-How or Joint Know-How of which Quark becomes aware from time to time,
to the extent reasonably relevant to Novartisβ practice of the license
granted under Section 2.1. Without limiting the foregoing, Quark will
deliver to Novartis (or its designee) all manufacturing batch records,
Development reports, analytical results, filings and correspondence with
any Regulatory Authority (including notes or minutes of any meetings with
any Regulatory Authority), raw material and excipient sourcing
information, quality audit findings and any other relevant technical
information relating to any Quark Compounds and/or
Products.
|
Β
4.2
|
Transition
Plan.Β Β Within [*] of the License Effective Date, the
Parties shall agree a plan (βTransition Planβ) for
the transfer to Novartis of all Development and manufacturing activities
then being undertaken by Quark, taking into account Quarkβs obligations to
complete the DGF Phase II Trial and/or the AKI Phase II Trial, and any
other ongoing clinical or pre-clinical studies, as set forth in Section
5.1(a).Β Β Quark shall, without additional consideration,
transition all such activities to Novartis in accordance with the
Transition Plan.
|
Β
[ * ] = 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.
Β
Β
16
Β
Β
4.3
|
Assignment of
Agreements.Β Β Quark shall cooperate and assist Novartis by
assigning to Novartis or its designee any agreements which Quark may have
entered into prior to the License Effective Date specifically relating to
the development, manufacture or supply of any Quark Compound or Product
which Novartis, in its sole discretion, deems useful or necessary to
further its obligations under this Agreement, provided however that Quark
shall not be obligated to assign to Novartis any intellectual property
rights obtained under such agreements and Quark shall not be obligated to
assign to Novartis any agreement relating solely to non-clinical
research.Β Β If any such assignment requires the consent of the
applicable counterparty, Quark shall not be obligated to make such
assignment until such consent is obtained; provided, however, that Quark
shall use commercially reasonable efforts to obtain such consent (it being
understood that Quark shall in no event be obligated to make any payment
to a counterparty to secure such consent).Β Β Quark shall stop any
work related to Quark Compound or Product under any agreements not
assigned to Novartis. In cases where Quark is unable to or elect not to
assign such intellectual property rights obtained under such agreements,
Quark shall ensure (at a minimum) that Novartis has an exclusive (where
possible and if not possible, a non-exclusive), sub-licensable license
under such intellectual property rights to research, Develop, make, use,
import, export, offer for sale, sell and otherwise Commercialize, or have
any of the foregoing done on its behalf, the Quark Compounds and Product
in Field in the Territory.
|
Β
4.4
|
Compound
Transfer.Β Β Within [*] following the License Effective
Date, Quark or its Affiliates, shall provide to Novartis or its designated
Affiliate such quantities of the Quark Compounds and/or Product in Quarkβs
possession as may be reasonably requested by Novartis for use by Novartis
and its Affiliates in connection with its Development activities under
this Agreement, which supplies shall be provided to Novartis at
[*].
|
Β
4.5
|
Cooperation.Β Β From
time to time during the term of this Agreement at the request of Novartis,
Quark will provide reasonable assistance to Novartis or its designated
Affiliate in connection with understanding and using the Quark Know-How
and Joint Know-How for purposes consistent with licenses and rights
granted to Novartis hereunder, including by providing information to
assist Novartis or its designated Affiliate in developing formulations of
any Product and its related activities, provided that during the period of
[*] from the License Effective date, such assistance (including travel to
sites other than Quark facilities) shall be provided without charge to
Novartis. After such [*] period such assistance shall, where provided at
Quark facilities or by telephone, continue to be provided without charge,
provided [*].
|
Β
5.
|
DEVELOPMENT
|
Β
5.1
|
Completion of DGF Phase II
Trial and AKI Phase II
Trial.
|
Β
Β
|
(a)
|
To
the extent that either or both of the DGF Phase II Trial and/or the AKI
Phase II Trial have not been completed as of the License Effective Date,
Quark will be responsible for completing, and shall use Commercially
Reasonable Efforts to complete, at its sole cost and expense and in
accordance with the Quark Development Plan, such trial(s), including the
preparation and finalization of all Phase II Trial Reports.Β Β The
DGF Phase II Trial shall be completed in accordance with the DGF Phase II
Trial Protocol and the AKI Phase II Trial shall be completed in accordance
with the AKI Phase II Trial Protocol.Β Β Quark shall also be
responsible for completing, and shall use Commercially Reasonable Efforts
to complete, at its sole cost and expense and in accordance with the Quark
Development Plan, any other clinical or pre-clinical studies that are
ongoing as of the License Effective Date, including the preparation and
finalization of complete, signed, detailed, data cleaned, statistically
analyzed, unbiased, unblended, unblinded and cGCP/cGLP audited and
compliant final report(s) for any such studies.Β Β Notwithstanding
the foregoing, if Quark is unable to [*] as specified in the [*] and/or
the [*], as applicable, after [*], Quark [*], and the Parties shall
negotiate in good faith as to how to proceed.Β Β Notwithstanding
the foregoing, [*].Β Β For clarity, in no event shall Quark be
obligated to implement any changes to the Quark Development Plan, the DGF
Phase II Trial Protocol, or the AKI Phase II Trial Protocol that would
have the effect of increasing the cost of the DGF Phase II Trial and/or
the AKI Phase II Trial.
|
Β
[ * ] = 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.
Β
Β
17
Β
Β
Β
|
(b)
|
No
less than [*] prior to each scheduled meeting of the JSC, Quark will
provide the Novartis members of the JSC with a written report on the
status and progress of its activities under Section 5.1(a), which reports
shall include information on progress versus plan, protocol deviations,
notable safety and efficacy findings (including serious adverse events and
events of interest from risk management perspective), audit findings, and
summaries of all interactions, and copies of all correspondence, with
Regulatory Authorities since the previous such
report.
|
Β
Β
|
(c)
|
Quark
shall make available such information about any ongoing studies under
Section 5.1(a) as may be reasonably requested by Novartis from time to
time, including such information as may be reasonably required to
facilitate scientific/medical publications regarding the Quark Compounds
or Products; provided, however, that
all such releases of information shall be subject to Novartisβ approval in
accordance with Section 16.3(a).Β Β In addition, and without
limiting the foregoing, Quark will provide Novartis with (to the extent
not previously disclosed under the Option
Agreement):
|
Β
Β
|
(i)
|
The
DGF DMC Top Line Interim Report within [*] of the final dosing of the last
patient for each interim analysis in the DGF Phase II
Trial;
|
Β
Β
|
(ii)
|
The
DGF [*] Report within [*] of the final dosing of the last patient for the
DGF Phase II Trial;
|
Β
Β
|
(iii)
|
The
DGF Final Report within [*] of the final dosing of the last patient for
the DGF Phase II Trial;
|
Β
Β
|
(iv)
|
The
AKI First Interpretable Results within [*] of the final dosing of the last
patient for the AKI Phase II Trial;
and
|
Β
Β
|
(v)
|
The
AKI Final Report within [*] of the final dosing of the last patient for
the AKI Phase II Trial.
|
Β
[ * ] = 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.
Β
Β
18
Β
Β
Each such
report shall be deemed to have been accepted by Novartis [*] after it was first
made available to Novartis in final and complete form; provided, that
Novartis has not, during such [*] period, issued notice to Quark reasonably
disputing whether the applicable report meets the requirements set forth in the
definition of such report under the Option Agreement and stating a list of
specific deficiencies that, if corrected, would cause the applicable report to
meet such requirements.Β Β If Quark provides a corrected report that
reasonably addresses such deficiencies, such report shall be deemed to have been
accepted by Novartis [*] after it was first made available to Novartis in such
revised final and complete form.Β Β If Novartis believes the report, as
submitted by Quark in such revised final and complete form, did not reasonably
address such deficiencies, it shall promptly advise Quark and the Parties shall
seek to resolve such dispute.Β Β If the Parties do not reach agreement
on such matter, either Party may submit the issue to an arbitration under
Section 17.5.Β Β If the arbitration rules in favor of Quark, the
applicable Phase II Trial Report shall be deemed to have been accepted by
Novartis upon the issuance of such ruling but the applicable time period set
forth in Section 8.2(a)(ii), 8.2(a)(iii), 8.2(a)(iv), 8.2(a)(v), 8.2(b)(i),
8.2(b)(ii), 8.2(c), 8.2(d)(i), 8.2(d)(ii) or 8.2(e) with respect to the election
of discretionary payment after the acceptance of such report shall be [*]
following receipt of the written decision of the arbitration.Β Β If the
arbitration rules in favor of Novartis, then Quark shall revise the report in
accordance with the ruling of the arbitrator and shall resubmit it to Novartis,
and the applicable time period set forth in Section 8.2(a)(ii), 8.2(a)(iii),
8.2(a)(iv), 8.2(a)(v), 8.2(b)(i), 8.2(b)(ii), 8.2(c), 8.2(d)(i), 8.2(d)(ii) or
8.2(e) shall then commence.
Β
Β
|
(d)
|
Until
completion of the DGF Phase II Trial and the AKI Phase II
Trial:
|
Β
Β
|
(i)
|
Quark
will be responsible for, and will use diligent efforts in, obtaining and
maintaining all Regulatory Approvals necessary for the conduct of the
applicable trial;
|
Β
Β
|
(ii)
|
Quark
will provide to Novartis copies of all substantive written communications
received by Quark (or its Affiliates) from any Regulatory Authority
related to the applicable trial or otherwise relevant to any Quark
Compound or Product;
|
Β
[ * ] = 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.
Β
Β
19
Β
Β
Β
|
(iii)
|
While
Quark is conducting the DGF Phase II Trial and/or the AKI Phase II Trial,
Quark will, where possible, advise Novartis not less than [*] in advance
of entering into any correspondence or substantive discussion with any
Regulatory Authority related to the applicable trial or otherwise relevant
to any Quark Compound or Product, and will provide to Novartis copies of
all substantive written communication to and from such Regulatory
Authority.Β Β Novartisβ approval shall be required for Quark to
enter into such correspondence or discussion, except as may be required by
applicable laws or regulations.Β Β After Quark has completed both
the DGF Phase II Trial and AKI Phase II Trial, Quark will not enter into
any correspondence or discussion with any Regulatory Authority related to
the applicable trial or otherwise relevant to any Quark Compound or
Product, except as may be required by applicable laws or regulations and
except that Quark may send to Regulatory Authorities correspondence which
relates to the DGF Phase II Trial or the AKI Phase II Trial (as
applicable) and which has been previously approved by
Novartis;
|
Β
Β
|
(iv)
|
At
Novartisβ request, Quark will request and seek to arrange meetings and
consultations with Regulatory Authorities to the extent required for the
DGF Phase II Trial and/or the AKI Phase II Trial or for any other purpose
related to Novartisβ ongoing or planned Development activities with
respect to any Product; and
|
Β
Β
|
(v)
|
Novartis
shall have the right to have representatives of Novartis attend and
participate in all meetings between Quark (or its Affiliates) and any
Regulatory Authority relating to the DGF Phase II Trial and/or the AKI
Phase II Trial, except to the extent prohibited by applicable laws or
regulations.
|
Β
Β
|
(e)
|
Upon
the latter of closure of the [*] database for the DGF Phase II Trial and
(ii)Β closure of the [*] database for the AKI Phase II Trial, all
Regulatory Filings with any Regulatory Authority relating to the Quark
Compounds and/or the Products which Quark was required to retain in order
to complete the DGF Phase II Trial and/or the AKI Phase II Trial, shall be
deemed assigned and transferred by Quark to Novartis, and upon request by
Novartis, Quark shall deliver notices of such assignment and transfer to
applicable Regulatory Authorities.
|
Β
5.2
|
Development.Β Β Subject
to Sections 5.1, 5.3 and 5.4, with effect from the License Effective Date,
Novartis will be responsible for conducting, at its sole expense, such
research and preclinical, clinical and other Development of the Quark
Compounds and/or Product as it determines appropriate in its sole
discretion.
|
Β
5.3
|
Development
Diligence.Β Β Novartis shall itself, or through its
Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop
at least one Product in the Field.Β Β Subject to compliance with
the foregoing, the Development of the Products shall be in Novartisβ sole
discretion.
|
Β
[ * ] = 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.
Β
Β
20
Β
Β
5.4
|
Quark Development Activities In
Israel.Β Β Novartis shall notify Quark in writing the
planned commencement date for the first Phase III Clinical Trial for the
Product.Β Β Quark shall have the right, exercisable by notice in
writing to Novartis no later than [*] prior to such planned commencement
for the first Phase III Clinical Trial for the Product (or, if later, not
more than [*] after receipt of the foregoing Novartis notice), to conduct
(itself or through one of its Affiliates) a portion of each Phase III
Clinical Trial of any Product in Israel in accordance with the protocols
and other governing documents developed by, and under the oversight of,
the JSC.Β Β Novartis shall pay a [*] to Quark for any clinical
trial activities conducted by Quark in Israel consistent with [*] that [*]
for [*] for the [*], and the Parties shall execute a customary agreement
covering Quarkβs performance of such clinical trials, it being understood
and agreed that Quark shall conduct all such activities: (i) at Novartisβ
direction and in accordance with Novartisβ development plan and protocols
for the applicable trial and the agreed budget; and (ii) in accordance
with all applicable laws and regulations regarding the conduct of clinical
trials, including but not limited to compliance with cGLP, cGMP, cGCP and
if appropriate ICH guidance or if higher, Novartis standards as
communicated to Quark.Β Β For each Product, the JSC shall agree
[*] in [*] for each [*]; provided however, if Novartis reasonably
determines that the indication being studied is [*] in the [*], Quarkβs
right to [*] in [*] shall not apply to any Product in such
indication.Β Β [*]
|
Β
5.5
|
Regulatory.
|
Β
Β
|
(a)
|
Promptly
after the License Effective Date, Quark will assign or transfer to
Novartis the ownership of all existing Regulatory Filings for the Products
in the Territory, other than any Regulatory Filing which Quark is required
to retain in order to complete its activities under Section 5.1(a), which
Regulatory Filings shall be assigned or transferred to Novartis as set
forth in Section 5.1(e).Β Β Other than as expressly set forth in
Section 5.1 above, Novartis will own all Regulatory Filings and Regulatory
Approvals for the Product in the Territory, and for clarity, Novartis will
(i)Β determine the regulatory plans and strategies for the Quark
Compounds and/or Product, (ii) make all Regulatory Filings with respect to
the Product and (iii) will be responsible for obtaining and maintaining
Regulatory Approvals throughout the Territory in the name of Novartis or
its Affiliates or sublicensees.
|
Β
Β
|
(b)
|
Quark
shall fully cooperate with and provide assistance to Novartis in
connection with filings to any Regulatory Authority relating to the Quark
Compounds and/or Product(s), including by executing any required
documents, providing access to personnel and providing Novartis with
copies of all reasonably required
documentation.
|
Β
Β
|
(c)
|
To
the extent requested by Novartis, Quark shall grant or use commercially
reasonable efforts to cause to be granted to Novartis and its Affiliates
or sublicensees cross-reference rights to any relevant drug master files
and other filings submitted by Quark or its Affiliates with any Regulatory
Authority.
|
Β
Β
|
(d)
|
Novartis
shall have the right to disclose the existence of, and the results from,
any clinical trials conducted under this Agreement in accordance with
Section 16.3(b) of this Agreement.
|
Β
[ * ] = 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.
Β
Β
21
Β
Β
5.6
|
Compliance. Each Party
agrees that in performing its obligations under this Agreement (a)Β it
shall comply with all applicable current international regulatory
standards, including cGMP, cGLP, cGCP and other rules, regulations and
requirements and (b)Β it will not employ or use any person that has
been debarred under Section 306(a) or 306(b) of the U.S. Federal Food,
Drug and Cosmetic Act.
|
Β
6.
|
MANUFACTURING
|
Β
6.1
|
Manufacturing.
|
Β
Β
|
(a)
|
Quark
shall be solely responsible for procuring such quantities of any Quark
Compounds and Products as may be required to complete the DGF Phase II
Trial and the AKI Phase II Trial, and any other pre-clinical and other
clinical studies to be completed by Quark under Section
5.1.
|
Β
Β
|
(b)
|
Upon
request by Novartis in its sole discretion, Quark shall also procure such
quantities of any Quark Compounds and Products as may be required by
Novartis, its Affiliates or sublicensees for Phase III Clinical Trials for
the AKI Indication and the DGF Indication, and any pre-clinical and other
clinical studies planned as of the License Effective Date, subject to the
terms and conditions of any existing Third Party manufacturing
agreement.Β Β Quark shall supply Novartis with all such
requirements at a price equal to
[*].
|
Β
Β
|
(c)
|
Other
than as set forth in Sections 6.1(a) and (b), with effect from the License
Effective Date, Novartis or its designated sublicensee(s) will be solely
responsible for the manufacture and supply of the Quark Compounds and
Products being Developed or Commercialized under this
Agreement.
|
Β
6.2
|
Manufacturing Know-How and
Assistance.
|
Β
Β
|
(a)
|
Without
limiting the provisions of Sections 4.1 and 4.5, during the period from
the License Effective Date until the First Commercial Sale of the Quark
Compounds and/or Products under this Agreement, Quark
shall:
|
Β
Β
|
(i)
|
fully
cooperate with and provide assistance to Novartis or its designee, through
documentation, consultation, training and face-to-face meetings, to enable
Novartis or its designee in an efficient and timely manner to proceed with
Development and manufacturing of the Quark Compounds and/or Product and to
obtain all appropriate Regulatory Approvals for manufacturing (including
qualification by the applicable Regulatory Authority of manufacturing
sites); and
|
Β
[ * ] = 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.
Β
Β
22
Β
Β
Β
|
(ii)
|
make
appropriate personnel available to assist Novartis or its designee at any
time and from time to time as reasonably requested by Novartis, and shall
provide the appropriate personnel of Novartis or its designee with access
to the personnel and manufacturing and other operations of Quark (or its
Third Party supplier(s)) for such periods of time and in such manner as is
reasonable in order to familiarize the personnel of Novartis or its
designee with Quark Know-How and Joint Know-How relating to the
Development and manufacture of the Quark Compounds and/or Products and the
application of the same.Β Β At Novartisβ request, such assistance
shall also be furnished at the manufacturing facilities of Novartis or its
designee.
|
Β
During
the period of [*] from the License Effective Date, such assistance (including
travel to sites other than Quark facilities) shall be provided without charge to
Novartis. After such [*] period such assistance shall, where provided at Quark
facilities or by telephone, continue to be provided without charge, provided that
[*].
Β
Β
|
(b)
|
Quark
shall fully cooperate with Novartis in complying with requirements of 35
U.S.C. Β§200 through 212, including requesting waivers where
appropriate.
|
Β
7.
|
COMMERCIALIZATION
|
Β
7.1
|
Commercialization. Other
than as set forth in Section 7.2, Novartis will be solely responsible for
all aspects of Commercialization of the Product in the Territory,
including planning and implementation, distribution, booking of sales,
pricing and reimbursement.Β Β Novartis shall itself, or through
its Affiliates or sublicensees, use Commercially Reasonable Efforts
[*].Β Β Notwithstanding the foregoing, Novartisβ application of
Commercially Reasonable Efforts shall not require Novartis to
commercialize a Product in any country or territory in which Novartis
determines it is not commercially reasonable to do so for such
Product.Β Β Subject to compliance with the foregoing, the
Commercialization of the Products shall be in Novartisβ sole
discretion.
|
Β
7.2
|
Quark Distribution Activities
In Israel.Β Β Quark shall have the right, exercisable by
notice in writing to Novartis no later than [*] following the date on
which Novartis advises Quark of Novartisβ first submission of an
application for Regulatory Approval of a Product anywhere in the
Territory, to be appointed (itself or through one of its Affiliates) as
the [*] distributor for Products in Israel.Β Β In the event that
Quark exercises such right, the Parties shall negotiate in good faith a
separate agreement with respect to such distribution arrangement on
commercially reasonable terms.
|
Β
[ * ] = 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.
Β
Β
23
Β
Β
7.3
|
Pharmacovigilance.
|
Β
(a)
|
Until
completion of the DGF Phase II Trial and the AKI Phase II Trial, Quark
will be responsible for maintaining a unified global adverse event
database for the Product and for performing all pharmacovigilance-related
activities in accordance with laws (including current Eudralex volume 9A
and current ICH E2 guidelines) applicable to a clinical trial
sponsor.
|
Β
(b)
|
Following
completion of the DGF Phase II Trial and the AKI Phase II Trial, Novartis
will be responsible for maintaining a unified global adverse event
database for the Product and for performing all pharmacovigilance-related
activities in countries where the Product is being Developed or
Commercialized by Novartis, its Affiliates or sublicensees in accordance
with laws (including current Eudralex volume 9A and current ICH E2
guidelines) applicable to a marketing authorization holder or to a
clinical trial sponsor, as applicable. Such activities for which Novartis
will be responsible include in particular the maintenance of a
pharmacovigilance system for the timely reporting of product quality
complaints, adverse events and product safety data related to the Product
to the relevant Regulatory Authorities in the Territory, and for
responding to safety issues and to all requests of Regulatory Authorities
in the Territory.
|
Β
(c)
|
Within
[*] following the License Effective Date, the Parties shall agree upon and
implement a procedure for the mutual exchange of adverse event reports and
safety information associated with the Products. Details of the operating
procedure respecting such adverse event reports and safety information
exchange shall be the subject of a mutually-agreed written
pharmacovigilance agreement between the Parties which shall be entered
into within such [*] period and in any event entered into prior to
transfer of any IND or corresponding application in any other country or
group of countries to Novartis.
|
Β
8.
|
FINANCIAL
PROVISIONS
|
Β
Β
|
8.1
|
Upfront
Payment.Β Β In partial consideration of the licenses and
rights granted to Novartis hereunder, Novartis shall pay to Quark a
one-time, non-refundable, non-creditable [*] upfront payment in the amount
specified in the applicable subsection below.Β Β For clarity, only
a single payment shall be due under this Section 8.1, depending on the
circumstances under which Novartis exercises the
Option.Β Β However, also depending on the circumstances of the
Option exercise and the occurrence of later events, discretionary license
fee payments may also arise under Section 8.2, in addition to milestones
and royalties.
|
Β
Β
|
(a)
|
If
either [*] or [*], and the Option is exercised before the termination of
the Option pursuant to Section [*] of the Option Agreement, then the
upfront payment shall be [*] USD (US$
[*]);
|
Β
[ * ] = 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.
Β
Β
24
Β
Β
Β
|
(b)
|
If
both [*] and [*], or [*] pursuant to Section [*] of the Option Agreement,
then, subject to Section 8.1(c)
below,
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β If
[*] and
Β
Β
Β
|
(A)
|
If
[*], and the Option is exercised prior to the termination of the Option
pursuant to Section [*] of the Option Agreement, then the upfront payment
shall be [*] USD (US$ [*]);
|
Β
Β
|
(B)
|
If
[*], and if [*], and the Option is exercised prior to the termination of
the Option pursuant to Section [*] of the Option Agreement, then the
upfront payment shall be [*] USD (US$
[*]);
|
Β
(ii)Β Β Β Β Β Β Β Β Β Β If
[*] and
Β
Β
|
(A)
|
If
[*], and the Option is exercised prior to the termination of the Option
pursuant to Section [*] of the Option Agreement, then the upfront payment
shall be [*] USD (US$ [*]);
|
Β
Β
|
(B)
|
If
[*], and if [*], and the Option is exercised prior to the termination of
the Option pursuant to Section [*] of the Option Agreement, then the
upfront payment shall be [*] USD (US$
[*]).
|
Β
Β
|
(c)
|
Notwithstanding
Section 8.1(b) above, if the Parties agree that Quark continues the DGF
Phase II Trial as set forth in [*], and the Option is exercised pursuant
to [*], then no upfront payment shall be payable and Novartis shall [*]
any discretionary payments which may become payable under the License
Agreement in accordance with Section
[*];
|
Β
Β
|
(d)
|
Notwithstanding
Sections 8.1(a), 8.1(b) and 8.1(c) above, Novartis may, at its sole
discretion, exercise the Option at any time prior to termination of the
Option pursuant to Section 4.1(b) of the Option Agreement and pay Quark an
upfront payment of [*] USD (US$ [*]), provided that if the Option is
exercised pursuant to this Section 8.1(d), the provisions of Section 8.2
shall not apply.
|
Β
Β
|
(e)
|
Any
amounts payable under this Section 8.1 shall be made within [*] after
receipt by Novartis of an invoice in the form of Exhibit C,
which invoice shall be issued no earlier than the License Effective
Date.
|
Β
[ * ] = 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.
Β
Β
25
Β
Β
8.2
|
Discretionary License
Payments.Β Β In order to maintain the licenses and rights
granted to it hereunder, Novartis may elect to make certain discretionary
payments, as follows:
|
Β
Β
|
(a)
|
If
Novartisβ exercise of the Option gave rise to a payment under Section [*],
then
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Novartis
may [*] either a payment made under Section [*], a payment made under Section
[*], or a payment made under Section [*], whichever is paid first;
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β If
[*], Novartis may elect in its sole discretion, but subject to Section 8.2(h),
to make a one-time, non-refundable, non-creditable payment to Quark of [*] USD
(US$ [*]), provided such election is made no later than [*] after the date on
which [*] was accepted by Novartis pursuant to Section 5.1(c);
Β
(iii)Β Β Β Β Β Β Β Β Β Β Β If
[*], Novartis may elect in its sole discretion, but subject to Section 8.2(h),
to make a one-time, non-refundable, non-creditable payment to Quark of [*] USD
(US$ [*]), provided such election is made no later than [*] after the date on
which [*] was accepted by Novartis pursuant to Section 5.1(c);
Β
(iv)Β Β Β Β Β Β Β Β Β Β Β If
Novartis has made the payment set forth in Section [*] above, and [*], Novartis
may elect in its sole discretion, but subject to Section 8.2(h), to make a
one-time, non-refundable payment to Quark of [*] USD (US$ [*]), provided such
election is made no later than [*] after the date on which [*] have been
accepted by Novartis pursuant to Section 5.1(c); and
Β
(v)Β Β Β Β Β Β Β Β Β Β Β If
Novartis has made the payment set forth in Section [*] above, and [*], Novartis
may elect in its sole discretion, but subject to Section 8.2(h), to make a
one-time, non-refundable payment to Quark of [*] USD (US$ [*]), provided such
election is made no later than [*] after the date on which [*] have been
accepted by Novartis pursuant to Section 5.1(c).
Β
For
clarity, the election by Novartis under each clause above is distinct from (and
in addition to) its election under any other clause.
Β
Β
|
(b)
|
If
Novartisβ exercise of the Option gave rise to a payment under Section [*],
then
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β If
[*], then Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable, non-creditable payment to Quark of
[*] USD (US$ [*]), provided such election is made no later than [*] after the
date on which [*] was accepted by Novartis pursuant to Section 5.1(c);
and
Β
[ * ] = 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.
Β
Β
26
Β
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β If
[*], then Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable payment to Quark of [*] USD (US$
[*]), provided such election is made no later than [*] after the date on which
[*] was accepted by Novartis pursuant to Section 5.1(c).
Β
Β
|
(c)
|
If
Novartisβ exercise of the Option gave rise to a payment under Section [*],
then Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable payment to Quark of [*] USD
(US$ [*]), provided such election is made no later than [*] after the date
on which [*] was accepted by Novartis pursuant to Section
5.1(c).
|
Β
Β
|
(d)
|
If
Novartisβ exercise of the Option gave rise to a payment under Section [*],
then
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β If
[*], then Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable, non-creditable payment to Quark of
[*] USD (US$ [*]), provided such election is made no later than [*] after the
date on which [*] was accepted by Novartis pursuant to Section 5.1(c);
and
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β If
[*], then Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable payment to Quark of [*] USD (US$
[*]), provided such election is made no later than [*] after the date on which
[*] was accepted by Novartis pursuant to Section 5.1(c).
Β
Β
|
(e)
|
If
Novartisβ exercise of the Option gave rise to a payment under Section [*],
then Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable payment to Quark of [*] USD
(US$ [*]), provided such election is made no later than [*] after the date
on which [*] was accepted by Novartis pursuant to Section
5.1(c).
|
Β
Β
|
(f)
|
If
Novartis exercised the Option (A) pursuant to Section [*] or (B) because
either [*] or [*] (as applicable), but [*] or [*] (as applicable), then,
subject to [*],Β Β Novartis may make the following discretionary
payments-
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Where
Novartis [*] for the [*], Novartis may elect in its sole discretion, but subject
to Section 8.2(h), to make a one-time, non-refundable payment to Quark of [*]
USD (US$[*]) provided that such election is made no later than [*] after the
date on which [*] by Novartis, or an Affiliate or sublicensee.
Β
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 406 of
the Securities Act of 1933, as amended.
Β
Β
27
Β
Β
(ii)Β Β Β Β Β Β Β Β Β Β Where
such [*] in Section 8.2(f)(i) above has been [*] and [*] for [*] then Novartis
may elect in its sole discretion, but subject to Section 8.2(h), to make a
one-time, non-refundable payment to Quark of [*] USD US$[*] provided that such
election is made no later than [*] after the date on which [*] by Novartis or an
Affiliate or sublicensee.
Β
(iii)Β Β Β Β Β Β Β Β Β Where
Novartis [*] for the [*], Novartis may elect in its sole discretion, but subject
to Section 8.2(h), to make a one-time, non-refundable payment to Quark of [*]
USD US$([*]) provided that such election is made no later than [*] after the
date on which [*] by Novartis, or an Affiliate or sublicensee.
Β
(iv)Β Β Β Β
Β Β Β Β Where such [*] in Section 8.2(f)(iii) above has been [*]
and [*] for [*] then Novartis may elect in its sole discretion, but subject to
Section 8.2(h), to make a one-time, non-refundable payment to Quark of [*] USD
US$[*] provided that such election is made no later than [*] after the date on
which [*] by Novartis or an Affiliate or sublicensee.
Β
(v)Β Β Β Β Β Β
Β Β Β Upon [*] for the [*] by Novartis (and Sections [*] and [*] do
not apply), Novartis may elect in its sole discretion, but subject to Section
8.2(h), to make a one-time, non-refundable payment to Quark of [*] USD (US$[*])
provided that such election is made no later than [*] after the date [*] by
Novartis, or an Affiliate or sublicensee.
Β
(vi)Β Β Β Β Β Β Β Β Β Upon
[*] for the [*] by Novartis (and Sections [*] and [*] do not apply), Novartis
may elect in its sole discretion, but subject to Section 8.2(g), to make a
one-time, non-refundable payment to Quark of [*] USD (US$[*]) provided that such
election is made no later than [*] after the date [*] by Novartis, or an
Affiliate or sublicensee.
Β
(vii)Β Β Β Β Β Β Β Β For
clarity, any payment due under this Section 8.2(f) is in addition to the
payments due under Section 8.4.
Β
Β
|
(g)
|
Novartis
shall issue written notice to Quark as to whether or not Novartis intends
making the applicable discretionary payments under Section 8.2(a)(ii),
8.2(a)(iii), 8.2(a)(iv), 8.2(a)(v), 8.2(b)(i), 8.2(b)(ii), 8.2(c),
8.2(d)(i), 8.2(d)(ii), 8.2(e), 8.2(f)(i), 8.2(f)(ii), 8.2(f)(iii),
8.2(f)(iv), 8.2(f)(v) or 8.2(f)(vi), as applicable, by the deadline set
forth therein.Β Β Quark may treat any failure by Novartis to issue
written notice to Quark by the applicable deadline as notice that Novartis
does not intend to make such discretionary payment (subject to a [*] cure
period).Β Β In the event that Novartis issues timely notice that
it intends making any such payment, such payment shall be made within [*]
after receipt by Novartis of an invoice in the form of Exhibit C
(subject to a [*] cure period), which invoice shall be issued no
earlier than the date of Novartisβ notice that it intends making the
applicable payment.
|
Β
[ * ] = 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.
Β
Β
28
Β
Β
Β
|
(h)
|
If
Novartis does not elect to make the payments described in Section
8.2(a)(ii), 8.2(a)(iii), 8.2(a)(iv), 8.2(a)(v), 8.2(b)(i), 8.2(b)(ii),
8.2(c), 8.2(d)(i), 8.2(d)(ii),Β Β 8.2(e), 8.2(f)(i), 8.2(f)(ii),
8.2(f)(iii), 8.2(f)(iv), 8.2(f)(v)Β Β or 8.2(f)(vi), as
applicable, then (subject to a [*] cure period) Quark shall have the right
to terminate this Agreement in its entirety, as set forth in Section
12.5.
|
Β
8.3
|
Financial Terms Following
Option Acceleration.Β Β Notwithstanding anything to the
contrary herein, if the Option is exercised by Novartis pursuant Section
3.4 of the Option Agreement, then the upfront payment and the
discretionary license payments set forth above in Sections 8.1 and 8.2
shall be adjusted as follows:
|
Β
Β
|
(a)
|
No
upfront or discretionary payments contained in Sections 8.1 and 8.2 shall
be due;
|
Β
Β
|
(b)
|
Novartis
shall pay to Quark a one-time, non-refundable payment to Quark of [*] USD
(US$[*]), which amount shall be made within [*] after receipt by Novartis
of an invoice in the form of Exhibit
C.Β Β For clarity, such [*] USD (US$[*]) is in addition to
the ten million USD (US$10,000,000) paid under Section 2.2 of the Option
Agreement;
|
Β
Β
|
(c)
|
The
amount of any Milestone Payments shall be reduced by
[*];
|
Β
Β
|
(d)
|
The
amount of any royalties applicable to Net Sales of Product shall be
reduced by [*] at each applicable royalty tier;
and
|
Β
Β
|
(e)
|
If
Quark believes that Novartisβ determination that an Insolvency Event has
or is likely to occur in connection with Quark was not reasonable, then
Quark may submit such dispute to binding arbitration pursuant to Section
17.5(b).Β Β If the arbitration determines that Novartisβs
determination that an Insolvency Event has or is likely to occur in
connection with Quark was not reasonable, then the following shall apply:
(i) Sections 8.3(a), (c) and (d) shall have no effect; (ii) Novartis shall
be deemed to have exercised its Option under Section [*] of this
Agreement, the [*] USD ($[*]) payment made by Novartis shall remain
non-refundable, the [*] USD (US$ [*]) payment under Section [*] shall be
deemed to have been paid, and Novartis may credit [*] USD ($[*]) against
any discretionary payments under Section 8.2; and (iii) [*].Β Β In
any event, if Quark actually experiences an Insolvency Event prior to the
fulfillment of its obligations to deliver the DGF Final Report and the AKI
Final Report (e.g., actually becomes insolvent), then the Novartis
determination shall be deemed to have been
reasonable.
|
Β
[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 406 of
the Securities Act of 1933, as amended.
Β
Β
29
Β
Β
8.4
|
Milestone
Payments.
|
Β
Β
|
(a)
|
DGF Indication
Milestones.Β Β In further consideration of the licenses and
rights granted to Novartis hereunder, upon first achievement of each of
the Milestones set forth below by Novartis, its Affiliates or sublicensees
with respect to the first Product developed for the DGF
Indication,
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Novartis
shall pay to Quark the corresponding one-time non-refundable non-creditable
Milestone Payments set forth below under the column heading βMilestone Payment
(USD)β; and
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β If
Novartis has made the discretionary payment set forth in Section [*], and
Novartis nonetheless continue the Development of Products for the DGF Indication
such that one or more Milestones set forth below are achieved, Novartis shall
pay to Quark the corresponding one-time non-refundable non-creditable Milestone
Payments set forth below under the column heading βAdditional Milestone Payment
(USD)β, which represents [*] associated with the DGF Indication, provided
however, that [*] i.e. [*].
Β
Milestone
|
Β |
Milestone
PaymentΒ (USD)
|
Β |
AdditionalΒ Milestone
PaymentΒ (USD)
|
[*]
Milestones
|
Β |
[*]
|
||
[*]
for the DGF Indication by Novartis, its Affiliates or
sublicensees
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
Milestones
|
Β | Β | ||
[*]
by Novartis, its Affiliates or sublicensees for the use of the Product for
the DGF Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees for the use of the Product for
the DGF Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees [*] for the use of the Product
for the DGF Indication [*]
|
Β |
US[*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees [*] for the use of the Product
for the DGF Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
Β
[ * ] = 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.
Β
Β
30
Β
Β
Β
|
(b)
|
AKI Indication
Milestones.Β Β In further consideration of the licenses and
rights granted to Novartis hereunder, upon first achievement of each of
the Milestones set forth below by Novartis, its Affiliates or sublicensees
with respect to the first Product developed for the AKI
Indication,
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Novartis
shall pay to Quark the corresponding one-time non-refundable, non-creditable
Milestone Payments set forth below under the column heading βMilestone Payment
(USD)β; and
Β
(ii)Β Β Β Β Β Β Β Β Β Β If
Novartis has made the discretionary payment set forth in Section [*], and
Novartis nonetheless continue the Development of Products for the AKI Indication
such that one or more Milestones set forth below are achieved, Novartis shall
pay to Quark the corresponding one-time non-refundable non-creditable Milestone
Payments set forth below under the column heading βAdditional Milestone Payment
(USD)β, which represents [*], provided however, that [*] i.e. [*].
Β
Milestone
|
Β |
Milestone
PaymentΒ (USD)
|
Β |
AdditionalΒ Milestone
PaymentΒ (USD)
|
[*]
Milestones
|
Β |
[*]
|
||
[*]
for the AKI Indication by Novartis, its Affiliates or
sublicensees
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
Milestones
|
Β | Β | ||
[*]
by Novartis, its Affiliates or sublicensees for the use of the Product for
the AKI Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees for the use of the Product for
the AKI Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees [*] for the use of the Product
for the AKI Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees [*] for the use of the Product
for the AKI Indication [*]
|
Β |
US$[*]
|
Β |
US$[*]
|
Β
Β
|
(c)
|
Milestones for Third Qualifying
Indication.Β Β In further consideration of the licenses and
rights granted to Novartis hereunder, upon first achievement of each of
the Milestones set forth below by Novartis, its Affiliates or
sublicensees, the corresponding one-time non-refundable non-creditable
Milestone Payments shall be payable by Novartis to Quark with respect to
the first Product developed for the Third Qualifying
Indication:
|
Β
[ * ] = 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.
Β
Β
31
Β
Β
Milestone
|
Β |
MilestoneΒ PaymentΒ (USD)
|
[*]
Milestones
|
||
[*]
for the Third Qualifying Indication by Novartis, its Affiliates or
sublicensees
|
Β |
US$[*]
|
[*]
Milestones
|
||
[*]
by Novartis, its Affiliates or sublicensees for the use of the Product for
the Third Qualifying Indication [*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees for the use of the Product for
the Third Qualifying Indication [*]
|
Β |
US$[*]
|
[*]
by Novartis, its Affiliates or sublicensees [*] for the use of the Product
for the Third Qualifying Indication [*]
|
Β |
US$[*]
|
[*]t
by Novartis, its Affiliates or sublicensees [*] for the use of the Product
for the Third Qualifying Indication [*]
|
Β |
US$[*]
|
Β
Β
|
(d)
|
Commercial
Milestones.Β Β In further consideration of the licenses and
rights granted to Novartis hereunder, upon first achievement of each of
the Milestones set forth below by Novartis, its Affiliates or
sublicensees, the corresponding one-time non-refundable non-creditable
Milestone Payments shall be payable by Novartis to
Quark:
|
Β
Milestone
|
Β |
MilestoneΒ PaymentΒ (USD)
|
Commercial
Milestones
|
||
First
Calendar Year in which worldwide annual Net Sales for any given Product
exceed US[*]
|
Β |
US$[*]
|
First
Calendar Year in which worldwide annual Net Sales for any given Product
exceed US[*]
|
Β |
US$[*]
|
First
Calendar Year in which worldwide annual Net Sales for any given Product
exceed US[*]
|
Β |
US$[*]
|
First
Calendar Year in which worldwide annual Net Sales for any given Product
exceed US$[*]
|
Β |
US$[*]
|
First
Calendar Year in which worldwide annual Net Sales for any given Product
exceed US$[*]
|
Β |
US$[*]
|
Β
[ * ] = 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.
Β
Β
32
Β
Β
Β
|
(e)
|
Each
Milestone Payment shall be deemed earned as of the first achievement of
the corresponding Milestone by any of the Products, and shall be notified
by Novartis to Quark within [*] after achievement of the Milestone, or in
the case of the Commercial Milestones, in the Sales and Royalty Report for
the Calendar Quarter in which such Commercial Milestone is
achieved.Β Β For the avoidance of doubt: (i) each Milestone
Payment shall be payable only on the first occurrence of the Milestone;
(ii) none of the Milestone Payments shall be payable more than once; and
(iii) other than as expressly set forth above, no additional Milestone
Payments shall be due for Milestones completed for the Development and
Commercialization of additional Products or of Products for any additional
indications or for any different Quark Compounds or Combination
Products.
|
Β
8.5
|
Royalty
Payments.
|
Β
Β
|
(a)
|
In
consideration of the licenses and rights to Novartis hereunder, during the applicable
Royalty Term, Novartis will make royalty payments to Quark, on a
Product-by-Product basis, based on Net Sales of the applicable Product in
the Territory by Novartis, its Affiliates and sublicensees, at the
applicable rates set forth below.
|
Β
AggregateΒ NetΒ SalesΒ ofΒ ApplicableΒ Product
throughoutΒ theΒ TerritoryΒ inΒ anyΒ Calendar
YearΒ byΒ Novartis,Β itsΒ AffiliatesΒ or
Sublicensees
|
Β |
RoyaltyΒ Rate
|
Portion
of annual Net Sales of the applicable Product which are less than or equal
to US$[*]
|
Β |
[*]%
|
Portion
of annual Net Sales of the applicable Product which are greater than
US$[*] and less than or equal to US$[*]
|
Β |
[*]%
|
Portion
of annual Net Sales of the applicable Product which are greater than
US$[*] and less than or equal to US$[*]
|
Β |
[*]%
|
Portion
of annual Net Sales of the applicable Product which are greater than
US$[*] and less than or equal to US$[*]
|
Β |
[*]%
|
Portion
of annual Net Sales of the applicable Product which are greater than
US$[*]
|
Β |
[*]%
|
Β
[ * ] = 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.
Β
Β
33
Β
Β
Β
|
(b)
|
For
example, if Net Sales of a given Product in a calendar year are $[*], the
royalty on such Net Sales shall be equal to
$[*]
|
Β
Β
|
(c)
|
Notwithstanding
the provisions of Section 8.9(a), for each Calendar Quarter in which there
has been any sale of a Product by Novartis, its Affiliates or
sublicensees, which, but for the licenses granted under the [*] (and the
sub-licenses thereto granted under this Agreement) would infringe an
issued patent within the [*] Patent Rights which has not expired or been
revoked, or held invalid or unenforceable, and which has not been admitted
to be invalid or unenforceable through reissue, disclaimer or otherwise,
Novartis shall pay to Quark an additional amount [*] with respect to such
sale of such Product under the [*], which shall [*] of Net Sales of such
Product in such Calendar Quarter.
|
Β
Β
|
(d)
|
Unless
otherwise provided in this Agreement, Royalties will be payable on a
Product-by-Product and country-by-country basis from First Commercial Sale
of such Product in such country until the later of (i)Β the expiration
of the last to expire Valid Claim covering the Compound, claiming the
Product or claiming the use for which the Product is being sold in such
country; (ii)Β [*];Β Β and (iii)Β ten (10)Β years from the
First Commercial Sale of such Product in such country (βRoyalty
Termβ).Β Β Following the Royalty Term on a
Product-by-Product and country-by-country basis, the licenses granted to
Novartis with respect to the Product shall continue in effect, but become
fully paid-up, sub-licensable, royalty-free, transferable, perpetual and
irrevocable with respect to such Product and such country,
[*].
|
Β
Β
|
(e)
|
For
the avoidance of doubt, royalties shall be payable only once with respect
to the same unit of Product.
|
Β
Β
|
8.6
|
Royalty
Step-Downs.
|
Β
Β
|
(a)
|
On
a Product-by-Product and country-by-country basis, for any period during
the Royalty Term but after the expiration
of:
|
Β
(i)Β Β Β Β Β Β Β Β Β Β Β the
last to expire Valid Claim of a [*] covering the Compound, claiming the Product
or claiming the use for which the Product is being sold in such
country;
Β
(ii)Β Β Β Β Β Β Β Β Β Β [*];
and
Β
(iii)Β Β Β Β Β Β Β Β Β ten
(10)Β years from the
First Commercial Sale of such Product in such country,
Β
in which
the sale of the Product in such country would, but for the license granted
hereunder, infringe a Valid Claim of a [*] in such country such that there is no
[*] being [*] in such country, the royalty applicable to Net Sales of such
Product in such country for the remainder of the Royalty Term shall be equal to
[*] of the weighted average royalty rate otherwise applicable to worldwide Net
Sales.
Β
[ * ] = 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.
Β
Β
34
Β
Β
Β
|
(b)
|
On
a Product-by-Product and country-by-country basis, for any period during
the Royalty Term, but after ten (10) years from the First Commercial Sale
of such Product in such country, in which the sale of a Product in any
country is covered by a Valid Claim and such Valid
Claim is [*] and there is a [*] in such country, then [*] in such country
for the remainder for the Royalty Term, except that [*] and the provisions
of Section [*] and Section [*] shall not
apply.
|
Β
Β
|
(c)
|
For
any period during the Royalty Term in which the sale of a Product in any
country is not covered by a Valid Claim or any Regulatory Exclusivity, the
royalty applicable to Net Sales of such Product in such country during
such period shall be equal to [*] of the weighted average royalty rate
otherwise applicable to worldwide Net Sales. The reduction set forth in
this Section 8.6(c) shall be [*] under this Agreement. This Section 8.6(c)
shall not apply if Section [*] applies or Section [*]
applies.
|
Β
Β
|
(d)
|
By
way of illustration of the Section 8.6(c) above, if Net Sales in a country
not covered by a Valid Claim were $[*] and total Net Sales for that year
were $[*], the following will apply.
[*]
|
Β
8.7
|
Loss of Market
Exclusivity. In the event of a Loss of Market Exclusivity in any
country, for the remainder of the Royalty Term, the royalty applicable to
Net Sales of such Product in such country shall be equal to [*] of the
weighted average royalty rate described above on worldwide Net Sales. The
reduction set forth in this Section 8.7 shall be [*] under this Agreement.
This Section 8.7 shall not apply if Section [*] or Section [*] applies or
Section [*] applies.
|
Β
8.8
|
No Valid Claim or Regulatory
Exclusivity and Loss of Market Exclusivity. For any period during
the Royalty Term in which the sale of a Product in any country is not
covered by a Valid Claim [*] and there is a Loss of Market Exclusivity in
such country, the royalty applicable to Net Sales of such Product in such
country during such period shall be equal to [*] of the weighted average
royalty rate otherwise applicable to worldwide Net Sales. The reduction
set forth in this Section 8.8 shall be [*] under this Agreement. This
Section 8.8 shall not apply if Section [*] applies.
|
Β
8.9
|
Third Party
Obligations.
|
Β
Β
|
(a)
|
Notwithstanding
the provisions of this Section 8.9, Quark shall remain responsible for the
payment of royalty, milestone and other payment obligations, if any, due
to Third Parties under any Quark Patents or Quark Know-How which have been
licensed to Quark and are sublicensed to Novartis under this Agreement,
including under the Alnylam License, the Silence License, the UIC License
and the Dharmacon License. All such payments shall be made promptly by
Quark in accordance with the terms of the applicable license
agreement(s).
|
[ * ] = 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.
Β
Β
35
Β
Β
Β
|
(b)
|
In
the event that Novartis reasonably determines that rights to intellectual
property related to p53 or siRNA owned or controlled by a Third Party are
required to research, Develop, manufacture, use, or Commercialize any
Product under this Agreement (in addition to the Quark Technology and
outside the intellectual property falling under the scope of sub-Section
8.9(a)), Novartis shall have the right to negotiate to and acquire such
rights through a license or otherwise and to deduct from the royalty
payments due to Quark [*] of the royalties paid by Novartis to such Third
Party; provided, however, that
in no event shall the royalty amounts due to Quark from Novartis be
reduced by more than [*] in any Calendar Quarter through this sub-Section
8.9(b). [*] Quark agrees to fully cooperate with Novartis to acquire such
rights.
|
Β
8.10
|
Royalty Floor.
Notwithstanding anything to the contrary in this Agreement, the
application of Sections [*], individually or in combination, shall not
during the Royalty Term reduce the royalty payment due to Quark below, on
a country-by-country basis, an amount equal to [*], provided, however,
that in any countries in which Loss of Market Exclusivity has occurred or
if the sale of a Product is not covered by a Valid Claim, such [*] shall
be [*] of the Net Sales. [*]
|
Β
8.11
|
No Projections. Quark
and Novartis acknowledge and agree that nothing in this Agreement shall be
construed as representing an estimate or projection of anticipated sales
of any Product, and that the Milestones and Net Sales levels set forth
above or elsewhere in this Agreement or that have otherwise been discussed
by the Parties are merely intended to define the Milestone Payments and
royalty obligations to Quark in the event such Milestones or Net Sales
levels are achieved. NEITHER QUARK NOR NOVARTIS MAKES ANY REPRESENTATION
OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT NOVARTIS, ITS AFFILIATES OR
SUBLICENSEES WILL BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE ANY
PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF SUCH
PRODUCT WILL BE ACHIEVED.
|
Β
9.
|
REPORTS
AND PAYMENT TERMS
|
Β
9.1
|
Payment
Terms.
|
Β
Β
|
(a)
|
Novartis
shall provide Quark with written notice of the achievement of each
clinical or regulatory Milestone within [*] after such Milestone is
achieved. After receipt of such notice, Quark shall submit an invoice to
Novartis substantially in the form of Exhibit C for
the corresponding Milestone Payment, provided that
no such invoice shall be submitted prior to the License Effective Date.
Novartis shall make the corresponding Milestone Payment within [*] after
receipt of such invoice. Within [*] after each Calendar Quarter during the
term of this Agreement, Quark shall submit an invoice to Novartis
substantially in the form of Exhibit C for
the costs incurred during such Calendar Quarter providing the assistance
under Sections 4.3(a), 4.3(c) and 4.3(d) of the Option Agreement and
Sections 4.5 and 6.2(a)(ii) of this Agreement. Novartis shall pay such
invoiced amount within [*] after receipt of such
invoice.
|
[ * ] = 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.
Β
Β
36
Β
Β
Β
|
(b)
|
Within
[*] after each Calendar Quarter during the term of this Agreement
following the First Commercial Sale of a Product, Novartis will provide to
Quark a Sales & Royalty Report in the form of Exhibit B. Such
Sales and Royalty Report will also inform Quark of the achievement of any
commercial Milestone. If requested by Quark, Novartis shall provide to
Quark additional information as reasonably necessary for Quark to fulfill
its reporting obligations to its upstream licensors. After receipt of such
report, Quark shall submit an invoice to Novartis substantially in the
form of Exhibit
C with respect to the royalty amount or Milestone Payment shown
therein. Novartis shall pay such royalty amount or Milestone Payment
within [*] after receipt of such
invoice.
|
Β
Β
|
(c)
|
All
payments from Novartis to Quark shall be made by wire transfer in US
Dollars to the credit of such bank account as may be designated by Quark
in this Agreement or in writing to Novartis. Any payment which falls due
on a date which is not a Business Day may be made on the next succeeding
Business Day.
|
Β
Β
|
(d)
|
For
the avoidance of doubt, no payments shall become due and payable and
neither Party will be obligated to reimburse the other Party for any costs
incurred by the other Party under or in connection with this Agreement
until the License Effective Date.
|
Β
9.2
|
Currency. All payments
under this Agreement shall be payable in US dollars. When conversion of
payments from any foreign currency is required to be undertaken by
Novartis, the USD equivalent shall be calculated using Novartisβ
then-current standard exchange rate methodology as applied in its external
reporting.
|
Β
9.3
|
Taxes.
|
Β
Β
|
(a)
|
If
any taxes are required to be withheld by Novartis from a payment made to
Quark pursuant to this Agreement, Novartis will: (i) deduct such taxes
from the payment made to Quark; (ii) timely pay the taxes to the proper
taxing authority for the account of Quark; (iii) send proof of payment to
Quark; and (iv) reasonably assist Quark in its efforts to obtain a credit
for such tax payment. Each Party agrees to reasonably assist the other
Party in lawfully claiming exemptions from and/or minimizing such
deductions or withholdings under an applicable tax treaty and any
applicable law.
|
Β
[ * ] = 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.
Β
37
Β
Β
Β
|
(b)
|
If
Novartis, its Affiliates, successors or sublicensees make payments under
this Agreement that are subject to withholding tax and such withholding
tax is in excess of the tax that would have been imposed on or deducted
from such payment had it been made by [*] to [*] eligible to claim
benefits under [*] between [*] and [*] (if any) in force at the time of
the payment, the applicable payor shall increase its payment to the extent
necessary so that after the deduction and withholding of the tax, Quark
receives the amount that it would have received had such payment been made
by [*] to [*] eligible to claim benefits under [*] between [*] and [*]. In
the event Novartis exercises its rights or performs its obligations under
this Agreement pursuant to the authority granted in Section 2.2 in a
manner that would increase the tax burden on Quark in a manner other than
withholding taxes provided for in this Section 9.3(b), Novartis shall
compensate Quark for such additional tax
burden.
|
Β
9.4
|
Late Payment. All
payments under this Agreement which is not paid on the date due shall bear
interest from the date due until paid at a rate equal to [*] per annum,
effective for the date that payment was due, as published by
[*].
|
Β
9.5
|
Records and Audit
Rights.
|
Β
Β
|
(a)
|
Each
Party shall, and Novartis shall ensure that its sublicensees hereunder,
keep complete, true and accurate books and records in accordance with its
Accounting Standards in relation to this Agreement, including, with
respect to Novartis and its sublicensees, in relation to Net Sales and
royalties. Each Party will keep such books and records for at least [*]
following the Calendar Quarter to which they pertain, provided that if [*]
in accordance with Section 9.5(b) below, such [*] retention period for
books and records by Novartis shall be
[*].
|
Β
Β
|
(b)
|
Quark
shall have the right for a period of [*] after receiving any Sales &
Royalty Report to appoint an internationally-recognized independent
accounting firm (which is reasonably acceptable to Novartis) (the βAuditorβ) to inspect the
relevant records of Novartis or its Affiliates to verify such reports,
statements, records or books of accounts, as applicable. In the sole event
[*] exercises its rights under the [*] to conduct an audit of Quark, Quark
shall have the right, for a period of [*] after receiving any Sales &
Royalty Report to appoint an Auditor to inspect the relevant records of
Novartis or its Affiliates to the extent required or necessary under the
[*]. In the event Novartis exercises the Option, [*]. Before beginning its
audit, the Auditor shall execute an undertaking acceptable to Novartis
pursuant to which the Auditor shall keep confidential all information
reviewed during such audit. The Auditor shall have the right to disclose
to Quark only its conclusions regarding any payments owed under this
Agreement.
|
Β
Β
|
(c)
|
Novartis
and its Affiliates shall make their records available for inspection by
such Auditor during regular business hours at such place or places where
such records are customarily kept, upon receipt of reasonable advance
notice from Quark, solely to verify the accuracy of the Sales &
Royalty Reports. Such inspection right shall not be exercised more than
[*] and not more [*]. Quark agrees to hold in strict confidence all
information received and all information learned in the course of any
audit or inspection, except to the extent necessary to enforce its rights
under this Agreement or if disclosure is required by law, regulation or
judicial order.
|
[ * ] = 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.
Β
38
Β
Β
Β
|
(d)
|
The
audit report and basis for any determination by an Auditor shall be made
available for review and comment by Novartis following Novartisβ request,
and Novartis shall have the right, at its expense, to request a further
determination by such Auditor as to matters which Novartis disputes within
[*] following receipt of such report. Novartis will provide Quark and the
Auditor with a reasonably detailed statement of the grounds upon which it
disputes any findings in the audit report and the Auditor shall undertake
to complete such further determination within [*] after the dispute notice
is provided by Novartis, which determination shall be limited to the
disputed matters. If the Parties disagree as to results of such further
determination, the dispute shall be subject to the dispute resolution
procedure specified in Section
17.5.
|
Β
Β
|
(e)
|
Unless
disputed, if an audit discloses any underpayment by Novartis, Novartis
shall promptly pay to Quark the amount of any such underpayment, together
with interest calculated pursuant to Section 9.4, within [*] of receiving
the final audit report establishing such obligation. Quark shall pay for
such audits, as well as its own expenses associated with such audit,
except that in the event there is any upward adjustment in aggregate
amounts payable for any year shown by such audit of more than [*] of the
amount paid, Novartis shall pay for such
audit.
|
Β
Β
|
(f)
|
If
Novartis discovers, whether by audit or otherwise that it has made an
overpayment, it will deduct such overpayment in the Sales and Royalty
Report for the next Calendar Quarter. To the extent that any overpayment
cannot be fully deducted from the royalty payment for such Calendar
Quarter, Novartis may deduct such amount from subsequent amounts due to
Quark until the full amount that Novartis was entitled to receive is
deducted. If the full amount cannot be deducted from subsequent amounts,
Quark shall promptly pay to Novartis the amount of any such overpayment
within [*] of receiving an invoice from
Novartis.
|
Β
Β
|
(g)
|
Quark
shall keep all books and records relating to any Development Costs
required to be reimbursed by Novartis pursuant to the Option Agreement
and/or this Agreement. Novartis shall have the right for the period of [*]
following the Calendar Quarter to which they pertain to appoint an
internationally-recognized independent accounting firm (which is
reasonably acceptable to Quark) to inspect the relevant records of Quark
or its Affiliates to verify such reports and statements, or books of
account, as applicable. Before beginning the audit, the Auditor shall
execute an undertaking acceptable to Quark pursuant to which the Auditor
will keep confidential all information reviewed during such audit. The
Auditor shall have the right to disclose to Novartis only its conclusions
regarding any payment owed under this Agreement. Quark and its Affiliates
shall make their records available for inspection by such Auditor during
regular business hours at such place or places where such records are
customarily kept, upon receipt of reasonable advance notice form Novartis.
The provisions of Section 9.5(d) and Novartis rights and obligations
contained therein shall apply mutatis mutandis to Quark in respect of any
such audit report. Unless disputed, if an audit discloses any overpayment
by Novartis, Quark shall promptly pay to Novartis the amount of any such
overpayment, together with interest calculated pursuant to Section 9.4,
within [*] of receiving the final audit report establishing such
obligation.
|
[ * ] = 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.
Β
39
Β
Β
10.
|
INTELLECTUAL
PROPERTY RIGHTS
|
Β
10.1
|
Ownership of
Inventions.
|
Β
Β
|
(a)
|
All
Know-How arising from the Partiesβ activities under this Agreement,
including any Patent Rights covering such inventions, made solely by
employees or consultants of a Party shall be owned by such
Party.
|
Β
Β
|
(b)
|
All
such Know-How arising from the Partiesβ activities under this Agreement,
including any Patent Rights covering such inventions, made jointly by
employees or consultants of both Parties shall be owned jointly by the
Parties as contemplated under US patent laws, including 35 U.S.C. Β§ 262.
Quark acknowledges and agrees that Quarkβs rights in any such Know-How and
Patent Rights are exclusively licensed to Novartis for the Quark Compounds
and Products in the Field. Each Party may use, or license to any Third
Party, any Joint Know-How and Joint Patents for any other purpose outside
Quark Compounds and Products without accounting to or obtaining the
approval of the other Partyβs prior written consent. However, neither
Party shall assign to any Third Party its interest in any Joint Patent
without the other Partyβs prior written consent (not to be unreasonably
withheld).
|
Β
Β
|
(c)
|
Determination
of inventorship shall be made in accordance with US patent laws and any
Patent Rights with a named inventor that is an employee or consultant of
each Party will be jointly owned by the Parties.
|
Β
10.2
|
Patent
Prosecution.
|
Β
Β
|
(a)
|
Quark
will be responsible for filing, prosecuting and maintaining the Quark
Patents and any Joint Patents at its own cost and expense, through a Third
Party law firm mutually agreed between the Parties. Novartis will fully
cooperate with Quark in connection with the filing, prosecution and
maintenance of the Quark Patents and any Joint Patents, including by
providing access to relevant persons and executing all documentation
reasonably requested by Quark. Quark will consult with Novartis and keep
Novartis reasonably informed of the status of such Quark Patents and Joint
Patents, it being understood and agreed that Quark shall make all
decisions relating thereto.
|
[ * ] = 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.
Β
40
Β
Β
Β
|
(b)
|
Quark
will notify Novartis of its decision as to the countries of the world in
which it elects to file, prosecute and maintain each Quark Patent and
Joint Patent, and shall notify Novartis as to any decision to cease
prosecution and/or maintenance of, or not to continue to pay the expenses
of prosecution and/or maintenance of, any such Quark Patent or Joint
Patent in any country in which it was filed. Quark will provide such
notices at least [*] prior to any filing or payment due date, or any other
due date that requires action, in connection with such Patent Right. In
the event that Novartis wants to file patent applications in countries
beyond those in which Quark decided to seek patent protection, or if
Novartis wants to prosecute and maintain such Quark Patents or Joint
Patents in countries where Quark has elected not to continue such
prosecution or maintenance, Quark shall permit Novartis, at its sole
discretion and expense but in the name of Quark (for Quark Patents) and in
the name of Quark and Novartis jointly (for Joint Patents), to file or to
continue prosecution or maintenance of such Quark Patent or Joint
Patent.
|
Β
Β
|
(c)
|
In
the event that any patent or patent application included in Quark Patents
or Joint Patents is challenged by a Third Party, including opposition or
reexamination, the Parties agree to cooperate with each other in the
defense of such patent or patent application, with each of Quark and
Novartis responsible for [*] of the cost associated with such defense.
Notwithstanding the foregoing, the defense of any patent challenges filed
(e.g. as a counterclaim) in connection with a infringement action brought
under Section 10.3 shall be controlled by the Party bringing such
infringement action. In the event Novartis is controlling the defense of a
challenge to a Quark Patent by reason of this Section 10.2(c), Novartis
shall meet and confer with Quark on a periodic basis to discuss such
defense and shall consider in good faith any issues raised by
Quark.
|
Β
Β
|
(d)
|
The
Parties acknowledge that Quark shall have the right to separate any claims
of a Quark Patent that are specific to the [*] of a Quark Patent and to
file such claims in a separate patent application [*], including without
limitation through the filing of one or more divisional applications at
the request of Novartis pursuant to Section 6.8 of the Option Agreement.
For the avoidance of doubt, any patent applications resulting from the
foregoing process that do not claim any [*] (β[*] Patentsβ) shall be
excluded from the definition of Quark Patents and Quark Technology for
purposes of this Agreement and the Option Agreement. Quark shall keep
Novartis reasonably informed of the status of such [*] Patents, it being
understood and agreed that Quark shall make all decisions relating
thereto.
|
Β
10.3
|
Patent
Infringement.
|
Β
Β
|
(a)
|
Each
Party will promptly notify the other of any infringement by a Third Party
of any of the Quark Technology or Joint Technology in the Field in the
Territory of which it becomes aware, including any βpatent certificationβ
filed in the United States under 21 U.S.C. Β§355(b)(2) or 21 U.S.C.
Β§355(j)(2) or similar provisions in other jurisdictions and of any
declaratory judgment, opposition, or similar action alleging the
invalidity, unenforceability or non-infringement of any of the Quark
Patents or Joint Patents which relates to Products or Competing Products
(collectively βThird
Party Infringementβ).
|
[ * ] = 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.
Β
41
Β
Β
Β
|
(b)
|
Novartis
will have the first right to bring and control any legal action in
connection with the Third Party Infringement at its own expense as it
reasonably determines appropriate, and Quark shall have the right, at its
own expense, to be represented in any such action by counsel of its own
choice. If Novartis fails to either (i) bring an action or proceeding with
respect to, or (ii) otherwise terminate, infringement of any Quark Patent
or Joint Patent (A) within [*] following the notice of alleged
infringement or (B) prior to [*] before the time limit,
if any, set forth in the appropriate laws and regulations for the filing
of such actions, whichever comes first, Quark shall have the right, upon
written notice to Novartis, to bring and control any such action at its
own expense and by counsel of its own choice, and Novartis shall have the
right, at its own expense, to be represented in any such action by counsel
of its own choice; provided, however, that
if Novartis notifies Quark in writing prior to [*] before such time limit
for the filing of any such action that Novartis intends to file such
action before the time limit, then Novartis shall be obligated to file
such action before the time limit, and Quark will not have the right to
bring and control such action.
|
Β
Β
|
(c)
|
At
the request of the enforcing Party, the other Party shall provide
reasonable assistance in connection therewith, including by executing
reasonably appropriate documents, cooperating in discovery and joining as
a party to the action if required.
|
Β
Β
|
(d)
|
In
connection with any such proceeding, Novartis shall not enter into any
settlement admitting the invalidity of, or otherwise impairing Quarkβs
rights in, the Quark Patents without the prior written consent of Quark,
which will not be unreasonably withheld or
delayed.
|
Β
Β
|
(e)
|
Any
recoveries resulting from such an action relating to a claim of Third
Party Infringement shall be first applied against payment of each Partyβs
costs and expenses in connection therewith. In the event that Novartis
brought such action, any remainder will be retained by (or if received by
Quark, paid to) Novartis; provided, however, that
any portion of such remainder that is attributable to lost profits with
respect to the applicable Product(s) shall be [*]. In the event that Quark
brought such action, any remainder shall be
[*].
|
Β
Β
|
(f)
|
Notwithstanding
the foregoing, Novartis acknowledges that as the Silence License and the
Alnylam License are non-exclusive, Novartis has no right to take actions
against Third Party Infringement with respect to the Patent Rights covered
by these two upstream licenses.
|
Β
Β
|
(g)
|
Quark
shall retain the exclusive right, at its own expense, to control the
enforcement of Quark Technology for Third Party activities which do not
relate to Products or Competing Products, provided, however, that, in the
event that not all of the [*] claims in a particular Quark Patent have
been separated into new application(s) (as described in Section 10.2(d)),
Quark shall [*] in advance of commencing an enforcement action for such
Quark Patent for Third Party activities that do not relate to Products or
Competing Products, [*]. The parties agree that
[*].
|
[ * ] = 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.
Β
42
Β
Β
Β
|
(h)
|
Quark
shall also retain the exclusive right, at its own expense, to control the
enforcement of the [*] Patents.
|
Β
10.4
|
Trademarks. Novartis
shall have the right to brand the Products using Novartis related
trademarks and any other trademarks and trade names it determines
appropriate for the Products, which may vary by country or within a
country (βProduct
Marksβ). Novartis shall own all rights in the Product Marks and
register and maintain the Product Marks in the countries and regions it
determines reasonably necessary.
|
Β
10.5
|
Patent extensions.
|
Β
Β
|
(a)
|
If
requested by Novartis, Quark shall cooperate in obtaining patent term
restoration (under but not limited to Drug Price Competition and Patent
Term Restoration Act), supplemental protection certificates or their
equivalents, and patent term extensions with respect to the Quark Patents
and/or Joint Patents in any country and/or region where applicable. Quark
shall provide all reasonable assistance requested by Novartis, including
permitting Novartis to proceed with applications for such in the name of
Quark, if deemed appropriate by Novartis, and executing documents and
providing any relevant information to
Novartis.
|
Β
Β
|
(b)
|
[*]
shall in [*] determine which, if any, Quark Patents and/or Joint Patents
it will apply to extend.
|
Β
10.6
|
[*]. The Parties
acknowledge and agree that, for any given Product, [*], depending on a
number of factors. As result, Quark may, in its discretion but subject to
the remainder of this Section 10.6, decide on a Product-by-Product and
country-by-country basis, whether [*] and may, in its discretion but
subject to the remainder of this Section 10.6, decide to [*]. In the event
that Novartis disagrees with any such decision by Quark in good faith, and
the Parties are unable to resolve such dispute within a reasonable time
period, then Parties agree to submit to a mutually agreed, independent [*]
having relevant experience in the field of siRNA technology the question
of whether [*] with respect to the applicable country(-ies) and
Product(s). The decision of such [*] shall be binding on the Parties. The
Parties shall share equally the fees and costs of such
[*].
|
Β
10.7
|
UIC License. Novartis
acknowledges that the UIC License contains a provision whereby
[*].
|
Β
10.8
|
Patent Marking. Novartis
agrees to xxxx the Product sold in the US with all applicable United
States patent numbers which are required pursuant to the terms of the [*].
All Products shipped or sold in other countries shall be marked in such a
manner as to conform with patent laws and practices of the country of
manufacture or sale. Immediately after the License Effective Date, Quark
[*].
|
Β
10.9
|
No Patent Challenge.
Quark may [*], to the extent it relates to the Quark Patents in the
territory [*], at any time on [*] written notice to Novartis (subject to
the [*] cure period in Section 12.2) if Novartis its Affiliates and
sublicenses, [*].
|
[ * ] = 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.
Β
43
Β
Β
11.
|
CONFIDENTIALITY
|
Β
11.1
|
Duty of
Confidence.
|
Β
Β
|
(a)
|
Subject
to the other provisions of this Article 11, all Confidential Information
disclosed by a Party or its Affiliates under this Agreement and/or the
Option Agreement will be maintained in confidence and otherwise
safeguarded by the recipient Party and its Affiliates. The recipient Party
may only use any such Confidential Information for the purposes of this
Agreement and pursuant to the rights granted to the recipient Party under
this Agreement. Subject to the other provisions of this Article 11, the
recipient Party and its Affiliates shall hold as confidential such
Confidential Information of the other Party or its Affiliates in the same
manner and with the same protection (in no case less than reasonable care)
as such recipient Party maintains its own confidential information.
Subject to the other provisions of this Article 11, a recipient Party may
only disclose Confidential Information of the other Party to: (i) its
Affiliates and sublicensees; and (ii) employees, agents, contractors,
consultants and advisers of the Party and its Affiliates and sublicensees,
in each case to the extent reasonably necessary for the purposes of, and
for those matters undertaken pursuant to, this Agreement, and, in the case
of Quark, pursuant to Quarkβs retained rights hereunder; provided that
such Persons are bound to maintain the confidentiality of the Confidential
Information in a manner consistent with the confidentiality provisions of
this Agreement.
|
Β
Β
|
(b)
|
With
respect to Quarkβs obligations under this Article 11, all Quark Know-How
and Joint Know-How shall be considered Confidential Information of
Novartis and Quark shall maintain in confidence and otherwise safeguard
such Quark Know-How and Joint Know-How as such in accordance with this
Article 11 (it being understood that the exceptions in sub-Sections
11.2(b) and (c) shall not apply to Quark with respect to Quark Know-How or
Joint Know-How), provided that
Quark may use Quark Know-How and Joint Know-How for those matters
undertaken pursuant to its retained rights
hereunder.
|
Β
11.2
|
Exceptions. The
obligations under this Article 11 shall not apply to any information to
the extent the recipient Party can demonstrate by competent evidence that
such information:
|
Β
Β
|
(a)
|
is
(at the time of disclosure) or becomes (after the time of disclosure)
known to the public or part of the public domain through no breach of this
Agreement by the recipient Party or its
Affiliates;
|
Β
Β
|
(b)
|
was
known to, or was otherwise in the possession of, the recipient Party or
its Affiliates prior to the time of disclosure by the disclosing Party or
any of its Affiliates;
|
[ * ] = 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.
Β
44
Β
Β
Β
|
(c)
|
is
disclosed to the recipient Party or an Affiliate on a non-confidential
basis by a Third Party who is entitled to disclose it without breaching
any confidentiality obligation to the disclosing Party or any of its
Affiliates; or
|
Β
Β
|
(d)
|
is
independently developed by or on behalf of the recipient Party or its
Affiliates, as evidenced by written records, without access or reference
to the Confidential Information disclosed by the disclosing Party or its
Affiliates under this Agreement.
|
Β
Specific
aspects or details of Confidential Information shall not be deemed to be within
the public domain or in the possession of the recipient Party merely because the
Confidential Information is embraced by more general information in the public
domain or in the possession of the recipient Party. Further, any combination of
Confidential Information shall not be considered in the public domain or in the
possession of the recipient Party merely because individual elements of such
Confidential Information are in the public domain or in the possession of the
recipient Party unless the combination and its principles are in the public
domain or in the possession of the recipient Party.
Β
11.3
|
Authorized
Disclosures.
|
Β
Β
|
(a)
|
In
addition to disclosures allowed under Section 11.2, each Party, its
Affiliates and sublicensees may disclose the other Partyβs Confidential
Information to the extent such disclosure is necessary in the following
instances: (i) filing or prosecuting Patent Rights as contemplated by this
Agreement; (ii) in connection with Regulatory Filings for Products; (iii)
prosecuting or defending litigation as contemplated by this Agreement;
(iv) complying with applicable court orders or governmental regulations;
or (v) to the extent otherwise necessary or appropriate in order to
fulfill its obligations or exercise its rights
hereunder.
|
Β
Β
|
(b)
|
In
addition, Novartis and its Affiliates and sublicensees may disclose
Confidential Information of Quark to Third Parties as may be necessary or
useful in connection with the research, Development, manufacture or
Commercialization of the Quark Compounds and/or Product(s) as contemplated
by this Agreement, including in connection with sublicensing and
subcontracting transactions, provided that such disclosee are bound by
obligations of confidentiality and non-use at least as equivalent in scope
as those set forth in this Article 11 prior to such
disclosure.
|
[ * ] = 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.
Β
45
Β
Β
Β
|
(c)
|
(A)
Quark and its Affiliates may disclose Confidential Information of Novartis
to any bona fide potential or actual investor other than (i) any potential
investor that is (or is an Affiliate of) a healthcare company and (ii) any
potential investor in which the sole limited partner is a healthcare
company, subject to entering into the confidentiality obligations
described below. (B) Quark may disclose the terms of this Agreement
(excluding financial terms) to potential acquirors, subject to entering
into the confidentiality obligations described below provided that
(i) any such potential acquirors have been formally accepted by Quark in
writing to conduct full due diligence for the purpose of the potential
acquisition; (ii) such due diligence in connection with the terms of this
Agreement shall be conducted at the offices of an
internationally-recognized law firm acceptable to Novartis and (iii) Quark
has notified Novartis in writing of the disclosure for the purpose of the
conduct of the due diligence by the potential acquiror without obligation
to identify such potential acquiror(s). In the case of a potential
acquiror and provided Quark has fulfilled the conditions described above
under (B)(i), (ii) and (iii) above, Quark may disclose the financial terms
of this Agreement to a Third Party advisor to such potential acquiror,
subject to entering into the confidentiality obligations described below.
Such advisor may not disclose the financial terms of this Agreement to the
potential acquiror but shall be permitted to review the valuation
assumptions of the potential acquiror and advise the potential acquiror
only whether the financial value of this transaction to Quark, taken as a
whole, is materially consistent with the assumptions made by the potential
acquiror or is materially superior to, or materially inferior to, such
assumptions. Any disclosure made by Quark pursuant to this Section 11.3(c)
may only be made to persons who have, prior to any disclosure, agreed in
writing to be bound by confidentiality obligations no less strict than
those set forth herein, including without limitation, obligations to use
the confidential information so disclosed for the sole purpose of
assessing a potential investment and/or acquisition of Quark as described
under this Section 11.3(c).
|
Β
Β
|
(d)
|
In
the event the recipient Party is required to disclose Confidential
Information of the disclosing Party by law or in connection with bona fide
legal process, such disclosure shall not be a breach of this Agreement;
provided
that the recipient Party (i) informs the disclosing Party as soon as
reasonably practicable of the required disclosure; (ii) limits the
disclosure to the required purpose; and (iii) at the disclosing Partyβs
request and expense, assists in an attempt to object to or limit the
required disclosure.
|
Β
11.4
|
Ongoing Obligation for
Confidentiality. Upon early termination of this Agreement for any
reason, each Party and its Affiliates shall immediately return to the
other Party or destroy any Confidential Information disclosed by the other
Party, except for one copy which may be retained in its confidential files
for archive purposes.
|
Β
12.
|
TERM
AND TERMINATION
|
Β
12.1
|
Term. The term of this
Agreement will commence upon the License Effective Date and continue, on a
Product-by-Product and country-by-country basis, until the expiration of
the royalty obligations of Novartis with respect to the applicable
Product, unless earlier terminated as permitted by this Agreement. Upon
expiration of the term of this Agreement, on a Product-by-Product and
country-by-country basis, the licenses granted to Novartis hereunder shall
continue in effect, as fully paid-up (except as set forth in the last
sentence in Section 8.5(d)), sub-licensable, royalty-free, transferable,
perpetual and irrevocable with respect to such Product and such
country.
|
[ * ] = 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.
Β
46
Β
Β
12.2
|
Termination for
Cause. If
either Novartis or Quark is in material breach of any material obligation
hereunder, the non-breaching Party may give written notice to the
breaching Party specifying the claimed particulars of such breach, and in
the event such material breach is not cured within [*] after such notice,
the non-breaching Party shall have the right thereafter to terminate this
Agreement immediately by giving written notice to the breaching Party to
such effect; provided, however, that
if such breach is capable of being cured but cannot be cured within such
[*] period and the breaching Party initiates actions to cure such breach
within such period and thereafter diligently pursues such actions, the
breaching Party shall have such additional period as is reasonable in the
circumstances to cure such breach. In the event that arbitration is
commenced with respect to any alleged breach hereunder, no purported
termination of this Agreement pursuant to this Section 12.2 shall take
effect until the resolution of such arbitration. Any termination by any
Party under this Section 12.2 and the effects of termination provided
herein shall be without prejudice to any damages or other legal or
equitable remedies to which it may be entitled from the other
Party.
|
Β
12.3
|
Termination for Insolvency.
Either Quark or Novartis may terminate this Agreement without
notice if an Insolvency Event occurs in relation to the other Party. In
any event when a Party first becomes aware of the likely occurrence of any
Insolvency Event in regard to that Party, it shall promptly so notify the
other Party in sufficient time to give the other Party sufficient notice
to protect its interests under this
Agreement.
|
Β
12.4
|
Termination by Novartis Without
Cause. Novartis may terminate this Agreement without cause at any
time after the License Effective Date in its entirety or on a
Product-by-Product or country-by-country basis at any time on [*] prior
written notice.
|
Β
12.5
|
Termination by Quark. In
the event that Novartis does not elect to make the payment described in
Section 8.2(a)(ii), 8.2(a)(iii), 8.2(a)(iv), 8.2(a)(v), 8.2(b)(i),
8.2(b)(ii), 8.2(c), 8.2(d)(i), 8.2(d)(ii), 8.2(e), 8.2(f)(i), 8.2(f)(ii),
8.2(f)(iii), 8.2(f)(iv), 8.2(f)(v) or 8.2(f)(vi), as applicable, then
Quark shall have the right to terminate this Agreement in its entirety, by
notice in writing within [*] after the [*] period after the date on which
[*] have been accepted by Novartis as set forth in Section
5.1(c).
|
Β
12.6
|
Rights in
Bankruptcy.
|
Β
Β
|
(a)
|
All
licenses granted under or pursuant to this Agreement are, and will
otherwise be deemed to be, for purposes of Section 365(n) of the US
Bankruptcy Code (the βCodeβ) and any similar
laws in any other country in the Territory, licenses of rights to
βintellectual propertyβ as defined under Section 101 of the Code. The
Parties agree that Novartis, as licensee of such rights under this
Agreement, will retain and may fully exercise all of its protections,
rights and elections under the Code and any similar laws in any other
country in the Territory. The Parties further agree that, in the event of
the commencement of a bankruptcy proceeding by or against any Quark under
the Code and any similar laws in any other country in the Territory,
Novartis 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 the same, if not already in its
possession, will be promptly delivered to it (i) upon any such
commencement of a bankruptcy proceeding upon its written request therefor,
unless Quark elects to continue to perform all of its obligations under
this Agreement, or (ii) if not delivered under (i) above, upon written
request therefor by Novartis following the rejection of this Agreement by
or on behalf of Quark.
|
[ * ] = 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.
Β
47
Β
Β
Β
|
(b)
|
All
rights, powers and remedies of Novartis provided for in this Section 12.6
are in addition to and not in substitution for any and all other rights,
powers and remedies now or hereafter existing at law or in equity
(including, without limitation, under the Code and any similar laws in any
other country in the Territory). In the event of the Bankruptcy of Quark,
Novartis, in addition to the rights, power and remedies expressly provided
herein, shall be entitled to exercise all other such rights and powers and
resort to all other such remedies as may now or hereafter exist at law or
in equity (including, without limitation, under the Code and any similar
laws in any other country in the Territory). The Parties agree that they
intend the following Novartis rights to extend to the maximum extent
permitted by law, including, without limitation, for purposes of the Code
and any similar laws in any other country in the Territory: (i) the right
of access to any intellectual property (including all embodiments thereof)
of Quark, or any Third Party with whom Quark contracts to perform an
obligation of Quark under this Agreement which is necessary for the
Development, registration, manufacture and/or Commercialization of
Products in the Territory; (ii) the right to contract directly with any
Third Party described in (i) to complete the contracted work, and (iii)
the right to cure any breach of or default under any such agreement with a
Third Party and set off the costs thereof against amounts payable to Quark
under this Agreement.
|
Β
13.
|
EFFECT
OF TERMINATION
|
Β
13.1
|
Termination by Novartis for
Cause. Upon termination of this Agreement by Novartis pursuant to
Sections 12.2 or 12.3:
|
Β
Β
|
(a)
|
the
licenses and other rights granted by Quark to Novartis under the Quark
Technology and Quarkβs interest in any Joint Technology will remain in
effect in accordance with their respective terms; provided, however,
that
|
Β
(i)Β Β Β Β Β Β Β Β Β
Β Β the license granted to Novartis in Section 2.1 shall become a
perpetual and irrevocable license;
Β
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β Novartis
s shall continue to make all Milestone Payments and royalty payments in
accordance with the terms of this Agreement, except that solely with respect to
a termination under Section 12.2 for a material breach by Quark that [*], the
amount of any future Milestone Payments and royalties applicable to future Net
Sales of Product shall be reduced by [*], provided that such reduction in
royalties shall in no event reduce the royalty payment due to Quark to an amount
less than [*].Β Β Such reduction in Milestone Payments and royalties
shall be credited against any monetary damages obtained by Novartis in a final
judgment or arbitration award as a result of Quarkβs breach. [*]
Β
[ * ] = 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.
Β
48
Β
Β
(iii)Β Β Β Β Β Β Β Β Β Β Novartis
shall have the right to offset the full amount of any remaining monetary damages
(i.e. in excess of the reduction set forth in subsection (ii) above) against any
Milestone Payments and/or royalties;
Β
Β
|
(b)
|
Quark
and Novartis shall continue to have the right to prosecute, maintain,
enforce and defend the Quark Patents and Joint Patents as specified in
Section 10.2;
|
Β
Β
|
(c)
|
Section
2.3 shall survive
with respect to Quark in accordance with its terms on a Product-by-Product
and country-by-country basis until the expiration of the royalty
obligations of Novartis; and
|
Β
Β
|
(d)
|
Except
as set forth in this Section 13.1 and in Section 13.3, the rights and
obligations of the Parties hereunder shall terminate as of the date of
such termination.
|
Β
In the
event that this Agreement is terminated with respect to only certain Product(s)
or certain country(ies), the provisions of this Section 13.1 shall apply only
with respect to the terminated Product(s) or country(ies), as
applicable.
Β
13.2
|
Termination by Quark for Cause
or by Novartis Without Cause. Upon termination of this Agreement by
Quark pursuant to Sections 12.2, 12.3 or 12.5 or by Novartis pursuant to
Section 12.4:
|
Β
Β
|
(a)
|
Any
licenses and other rights granted by either Party to the other will
terminate and revert to the granting
Party;
|
Β
Β
|
(b)
|
Novartis
will grant Quark a right of first negotiation, exercisable by written
notice to Novartis at any time within [*] to obtain an exclusive
worldwide, royalty-bearing license, with the right to sublicense, under
any Patent Rights of Novartis, including Novartisβ interest in Joint
Patents, to develop, make, have made, use, sell, have sold, offer for sale
and import such Products as are then being marketed or developed by
Novartis on commercially reasonable royalty terms to be negotiated in good
faith by the Parties for up to an additional [*] following exercise of
such right of first negotiation;
|
Β
Β
|
(c)
|
any
exclusive license granted to Quark as described in the preceding
sub-Section (b) will include the right to use clinical and regulatory data
and information generated by Novartis for regulatory purposes relating to
the applicable Products;
|
Β
Β
|
(d)
|
any
exclusive license agreement entered into as described in sub-Section (b)
will provide for Novartis to transfer and assign to Quark 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 (other than those related to Novartisβ manufacturing
facilities);
|
[ * ] = 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.
Β
49
Β
Β
Β
|
(e)
|
Quark
shall have the right, but not the obligation, to purchase from Novartis
some or all of the Quark Compound and/or Product then in Novartisβ
inventory at a price equal to [*]. Quark shall notify Novartis whether
Quark elects to exercise such purchase right within [*] after the grant of
a license to Quark pursuant to Section 13.2(b), or, where no such
negotiation takes place within [*] after the date of such
termination;
|
Β
Β
|
(f)
|
If
this Agreement is terminated by Novartis on a country-by-country basis,
then Novartis covenants that Novartis shall cease (and not restart)
Development and Commercialization of the Quark Compounds and/or Products
in any country where this Agreement has been terminated;
and
|
Β
Β
|
(g)
|
Except
as set forth in this Section 13.2 and in Section 13.3, the rights and
obligations of the Parties hereunder shall terminate as of the date of
such termination.
|
Β
In the
event that this Agreement is terminated with respect to only certain Product(s)
or certain country(ies), the provisions of this Section 13.2 shall apply only
with respect to the terminated Product(s) or country(ies), as
applicable.
Β
13.3
|
Survival. Expiration or
termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination. Without
limiting the foregoing, the provisions of Sections 1, 9.1 β 9.3 (to the
extent that Novartis continues to be obligated to pay Milestone Payments
and/or royalties to Quark pursuant to the applicable provisions of Article
13), 9.5, 10.1, 10.3 β 10.5 (to the extent that the licenses granted to
Novartis survive pursuant to the applicable provisions of Article 13),
10.8 β 10.9 (to the extent that the licenses granted to Novartis survive
pursuant to the applicable provisions of Article 13 and the relevant
upstream licenses are still in effect), 11, 13, 15, 16 and 17 shall survive
expiration or termination of this Agreement; provided, however, that in
the event of termination of this Agreement in its entirety by Quark
pursuant to Section 12.2, 12.3 or 12.5, or by Novartis in its entirety
pursuant to Section 12.4, Sections 11.1(b), 11.3(b) and 16.3, as well as
the proviso in the first sentence of Section 16.2 and the entire second
sentence of Section 16.2, shall not survive. The provisions of Article 11
(Confidentiality) shall survive the termination or expiration of this
Agreement for a period of [*].
|
Β
13.4
|
Termination Not Sole
Remedy. Termination is not the sole remedy under this Agreement
and, whether or not termination is effected and notwithstanding anything
contained in this Agreement to the contrary, all other remedies will
remain available except as agreed to otherwise
herein.
|
[ * ] = 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.
Β
50
Β
Β
14.
|
REPRESENTATIONS,
WARRANTIES AND COVENANTS
|
Β
14.1
|
Representations and Warranties
by Each Party.Β Each Party represents and warrants to the
other as of the Execution Date that:
|
Β
Β
|
(a)
|
it
is a corporation duly organized, validly existing, and in good standing
under the laws of its jurisdiction of
formation;
|
Β
Β
|
(b)
|
it
has full corporate power and authority to execute, deliver, and perform
this Agreement, and has taken all corporate action required by law and its
organizational documents to authorize the execution and delivery of this
Agreement and the consummation of the transactions contemplated by this
Agreement;
|
Β
Β
|
(c)
|
this
Agreement constitutes a valid and binding agreement enforceable against it
in accordance with its terms;
|
Β
Β
|
(d)
|
other
than compliance with the HSR Act, 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; and
|
Β
Β
|
(e)
|
the
execution and delivery of this Agreement and all other instruments and
documents required to be executed pursuant to this Agreement, and the
consummation of the transactions contemplated hereby and thereby do not
and shall not (i) conflict with or result in a breach of any provision of
its organizational documents, (ii) result in a breach of any agreement to
which it is a party; or (iii) violate any
law.
|
Β
14.2
|
Representations and Warranties
by Quark. Quark represents and warrants to Novartis as of the
Execution Date that:
|
Β
Β
|
(a)
|
Exhibit A sets
forth a complete and accurate list of (i) all Quark Patents in existence
as of the Execution Date, indicating the owner, Quark and/or co-owner(s)
thereof if any such Quark Patent is not solely owned by Quark and (ii) all
agreements that are in force as of the Execution Date under which any of
the Quark Patents are licensed to
Quark;
|
Β
Β
|
(b)
|
Quark
is the sole and exclusive owner, or exclusive licensee of all of the Quark
Patents (other than the Patent Rights licensed under the Silence License
and Alnylam License) existing on the Execution Date free from Encumbrances
and is listed in the records of the appropriate governmental agencies as
the sole and exclusive owner of record of each registration, grant and
application included in the Quark Patents that is owned by
Quark;
|
Β
Β
|
(c)
|
all
of its employees, officers, and consultants involved or to be involved in
the research or Development of the Quark Compound or Product have executed
agreements or have existing obligations under applicable laws requiring
assignment to Quark of all inventions made during the course of and as the
result of their association with Quark and obligating the individual to
maintain as confidential Quarkβs Confidential Information as well as
confidential information of other parties (including Novartis and its
Affiliates) which such individual may receive, to the extent required to
support Quarkβs obligations under this
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.
Β
51
Β
Β
Β
|
(d)
|
Quark
has the right to grant to Novartis the licenses under the Quark Patents
and Quark Know-How that it purports to grant
hereunder;
|
Β
Β
|
(e)
|
Quark
has the right to use and disclose and to enable Novartis to use and
disclose (in each case under appropriate conditions of confidentiality)
the Quark Know-How within the scope of the license(s) granted to Novartis
hereunder, free from Encumbrances;
|
Β
Β
|
(f)
|
[*],
there are no claims, challenges, oppositions, interference or other
proceedings pending or threatened against the Quark Patents, and Quark has
filed and prosecuted patent applications within the Quark Patents in good
faith and complied with all duties of disclosure with respect
thereto;
|
Β
Β
|
(g)
|
[*],
there are no claims, challenges or other proceedings pending or threatened
against any of the Quark Know-How;
|
Β
Β
|
(h)
|
[*],
Quark has not committed any act, or omitted to commit any act, that is
reasonably likely to cause the Quark Patents to expire prematurely or be
declared invalid or unenforceable;
|
Β
Β
|
(i)
|
all
application, registration, maintenance and renewal fees in respect of the
Quark Patents as of the Execution Date have been paid (to the extent due)
and all necessary documents and certificates have been filed with the
relevant agencies for the purpose of maintaining the Quark
Patents;
|
Β
Β
|
(j)
|
Quark
has not granted to any Third Party, including any academic organization or
agency, any rights to Commercialize the Quark Compounds or Product and has
disclosed any agreement with a Third Party pursuant to which such Third
Party has been granted rights to research or Develop the Quark Compounds
or Product ;
|
Β
Β
|
(k)
|
As
of the License Effective Date, Quark is not aware, after reasonable
inquiry, of any Third Party rights or technology not included in the Quark
Technology that is necessary and/or used for the Development of the Quark
Compounds and/or Products as they exist as of the License Effective
Date;
|
Β
Β
|
(l)
|
[*]
the research, Development, registration, manufacture, use or
Commercialization of the Quark Compounds or Product as they exist as of
the License Effective Date do not infringe the Patent rights of any Third
Party and the research, Development, use and manufacture of the Quark
Compounds and Product has been conducted by Quark without infringing the
Patent Rights or misappropriating the Know-How of any Third Party, and
Quark has not received any written notice alleging such infringement or
misappropriation;
|
[ * ] = 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.
Β
52
Β
Β
Β
|
(m)
|
Quark
has not initiated or been involved in any proceedings or claims in which
it alleges that any Third Party is or was infringing or misappropriating
any Quark Technology, nor have any such proceedings been threatened by
Quark, nor does Quark know of any valid basis for any such
proceedings;
|
Β
Β
|
(n)
|
no
officer or employee of Quark is subject to any agreement with any other
Third Party which requires such officer or employee to assign any interest
in any Quark Technology relating to the Quark Compounds or Product to any
Third Party;
|
Β
Β
|
(o)
|
Quark
has taken all reasonable precautions to preserve the confidentiality of
the Quark Know-How, to the extent such Quark Know-How is not generally
known in the relevant technical
field;
|
Β
Β
|
(p)
|
Quark
has not entered into a government funding relationship that would result
in rights to any Quark Compounds or Product residing in the US Government,
National Institutes of Health, National Institute for Drug Abuse or other
agency, and the licenses granted hereunder are not subject to overriding
obligations to the US Government as set forth in Public Law 96-517 (35
U.S.C. 200-204), as amended, or any similar obligations under the laws of
any other country;
|
Β
Β
|
(q)
|
Quark
has not granted any Third Party rights that would otherwise interfere or
be inconsistent with Novartisβ rights hereunder in a material manner, and
there are no agreements or arrangements to which Quark or any of its
Affiliates is a party relating to the Products, Quark Compounds, Quark
Patents, or Quark Know-How that limit or are reasonably likely to limit
the rights granted to Novartis under this Agreement or that restrict or
are reasonably likely to result in a restriction on Novartisβ ability to
Develop, manufacture, register, use or Commercialize the Quark Compounds
and the Products in the Territory;
|
Β
Β
|
(r)
|
Quark
has provided Novartis with a redacted copy of each agreement under which
it obtains rights to any of the Quark Patents, which copy sets forth all
of Quarkβs rights and obligations with regard to such
agreement;
|
Β
Β
|
(s)
|
[*],
neither Quark nor any of its Affiliates has committed any act which
amounts to a material breach of any of Quarkβs obligations under any
agreement under which it obtains rights to any of the Quark
Technology;
|
Β
Β
|
(t)
|
neither
Quark nor, to the knowledge of Quark, any employee, agent or subcontractor
of Quark involved in the research and Development of the Quark Compounds
or the Products has been debarred under Subsection (a) or (b) of Section
306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a);
and
|
Β
Β
|
(u)
|
Notwithstanding
anything to the contrary contained in this Agreement, Quark has [*] and
[*] that would be [*] to [*] in connection with this Agreement or the
transactions contemplated herein. [*], [*] provided by Quark to Novartis
regarding the Quark Compounds and Product as part of Novartisβ due
diligence under the Option Agreement are true and complete in all material
respects.
|
[ * ] = 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.
Β
53
Β
Β
14.3
|
Covenants.
|
Β
Β
|
(a)
|
Quark
covenants and agrees that:
|
Β
Β
|
(i)
|
it
will not grant any interest in the Quark Technology or Joint Technology
which is inconsistent with the terms and conditions of this Agreement, nor
shall Quark assign its right, title or interest in or to the Quark
Technology or Joint Technology to any Third Party and will use all
reasonable precautions to preserve the confidentiality of the Quark
Know-How and the Joint Know-How;
|
Β
Β
|
(ii)
|
it
will not grant any Third Party, including any academic organization or
agency, any rights to the Quark Compounds or Product (other than research
rights with the prior approval of the
JSC);
|
Β
Β
|
(iii)
|
it
will not amend or modify the terms of any agreement under which it obtains
rights to any of the Quark Technology in a way that materially affects
Novartisβ rights under this Agreement without the prior written consent of
Novartis;
|
Β
Β
|
(iv)
|
it
will not exercise any right to terminate any agreement under which it
obtains rights to any of the Quark Technology, provided such rights fall
with the scope of the license(s) granted to Novartis hereunder, without
the prior written consent of Novartis, except as provided in Section
10.6;
|
Β
Β
|
(v)
|
Quark
and its Affiliates will comply with, perform and observe in all material
respects all obligations under each agreement under which it obtains
rights to any of the Quark Technology, and will not commit any act or fail
to perform any obligation which would amount to a default or event of
default or which, with the giving of notice, the lapse of time or the
happening of any other event or condition would become a default or event
of default thereunder or give rise to any right of the applicable
counterparty to terminate any such agreement or any part
thereof;
|
Β
Β
|
(vi)
|
if,
at any time after execution of this Agreement, it becomes aware that it or
any employee, agent or subcontractor of Quark who participated, or is
participating, in the performance of any activities hereunder is on, or is
being added to the FDA Debarment List or any of the three (3) FDA Clinical
Investigator Restriction Lists referenced in Section 14.3(b), it will
provide written notice of this to Novartis within two (2) business days of
its becoming aware of this fact;
and
|
Β
[ * ] = 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.
Β
54
Β
Β
Β
|
(vii)
|
it
shall maintain insurance with respect to its activities and obligations
under this Agreement in such amounts as are commercially reasonable in the
industry for companies conducting similar business and shall require any
of its Affiliates undertaking activities under this Agreement to do the
same.
|
Β
Β
|
(b)
|
Each
Party covenants that (i) neither such Party nor, to the actual knowledge
of such Party, any employee, agent or subcontractor of such Party to be
involved in the Development of the Quark Compounds or the Products, has
been debarred under Subsection (a) or (b) of Section 306 of the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 335a); (ii) no Person who is known
by such Party to have been debarred under Subsection (a) or (b) of Section
306 of said Act will be employed by such Party in the performance of any
activities hereunder; and (iii) to the actual knowledge of such Party, no
Person on any of the FDA clinical investigator enforcement lists
(including, but not limited to, the (1) Disqualified/Totally Restricted
List, (2) Restricted List and (3) Adequate Assurances List) will
participate in the performance of any activities
hereunder.
|
Β
14.4
|
No Other Warranties.
EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 14, (A) NO REPRESENTATION,
CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF
NOVARTIS OR QUARK; AND (B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER
ARISING BY OPERATION OF LAW OR OTHERWISE ARE HEREBY EXPRESSLY EXCLUDED,
INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR
NON-INFRINGEMENT.
|
Β
15.
|
INDEMNIFICATION;
LIABILITY
|
Β
15.1
|
Indemnification by
Quark. Quark shall indemnify and hold Novartis, its Affiliates and
sublicensees, and their respective officers, directors and employees
(βNovartis
Indemniteesβ) harmless from and against any Claims against them [*]
from:
|
Β
Β
|
(a)
|
[*];
|
Β
Β
|
(b)
|
[*];
or
|
Β
Β
|
(c)
|
[*];
|
Β
provided, however, that Quark
[*].
[ * ] = 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.
Β
55
Β
Β
15.2
|
Indemnification by
Novartis. Novartis shall indemnify and hold Quark, its Affiliates,
and their respective officers, directors and employees (βQuark Indemniteesβ)
harmless from and against any Claims against them [*]
from:
|
Β
Β
|
(a)
|
[*];
|
Β
Β
|
(b)
|
[*];
or
|
Β
Β
|
(c)
|
[*];
|
Β
provided, however, that
Novartis [*].
Β
15.3
|
Indemnification
Procedure.
|
Β
Β
|
(a)
|
For
the avoidance of doubt, all indemnification claims in respect of a
Novartis Indemnitee or Quark Indemnitee shall be made solely by Novartis
or Quark, respectively.
|
Β
Β
|
(b)
|
A
Party seeking indemnification hereunder (βIndemnified Partyβ)
shall notify the other Party (βIndemnifying Partyβ) in
writing reasonably promptly after the assertion against the Indemnified
Party of any Claim or fact in respect of which the Indemnified Party
intends to base a claim for indemnification hereunder (βIndemnification Claim
Noticeβ), but the failure or delay to so notify the Indemnifying
Party shall not relieve the Indemnifying Party of any obligation or
liability that it may have to the Indemnified Party, except to the extent
that the Indemnifying Party demonstrates that its ability to defend or
resolve such Claim is adversely affected thereby. The Indemnification
Claim Notice shall contain a description of the claim and the nature and
amount of the Claim (to the extent that the nature and amount of such
Claim is known at such time). Upon the request of the Indemnifying Party,
the Indemnified Party shall furnish promptly to the Indemnifying Party
copies of all correspondence, communications and official documents
(including court documents) received or sent in respect of such
Claim.
|
Β
Β
|
(c)
|
Subject
to the provisions of sub-Sections (d) and (e) below, the Indemnifying
Party shall have the right, upon written notice given to the Indemnified
Party within [*] after receipt of the Indemnification Claim Notice to
assume the defense and handling of such Claim, at the Indemnifying Partyβs
sole expense, in which case the provisions of sub-Section (d) below shall
govern. The assumption of the defense of a Claim by the Indemnifying Party
[*]. In the event that it is [*]. If the Indemnifying Party does not give
written notice to the Indemnified Party, within [*] after receipt of the
Indemnification Claim Notice, of the Indemnifying Partyβs election to
assume the defense and handling of such Claim, the provisions of
sub-Section (e) below shall govern.
|
[ * ] = 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.
Β
56
Β
Β
Β
|
(d)
|
Upon
assumption of the defense of a Claim by the Indemnifying Party: (i) the
Indemnifying Party shall have the right to and shall assume [*] control
and responsibility for dealing with the Claim; (ii) the Indemnifying Party
may, at its own cost, appoint as counsel in connection with conducting the
defense and handling of such Claim any law firm or counsel reasonably
selected by [*]; (iii) the Indemnifying Party shall keep the Indemnified
Party informed of the status of such Claim; and (iv) the Indemnifying
Party shall have the right to [*]. The Indemnified Party [*] and shall be
[*]. In particular, the Indemnified Party shall furnish such records,
information and testimony, provide witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be reasonably
requested in connection therewith. Such cooperation shall include access
during normal business hours by the Indemnifying Party to, and reasonable
retention by the Indemnified Party of, records and information that are
reasonably relevant to such Claim, and making the Indemnified Party, the
indemnitees and its and their employees and agents available on a mutually
convenient basis to provide additional information and explanation of any
records or information provided.
|
Β
Β
|
(e)
|
If
the Indemnifying Party does not give written notice to the Indemnified
Party as set forth in sub-Section (c) or fails to conduct the defense and
handling of any Claim in good faith after having assumed such, the
Indemnified Party may, at the Indemnifying Partyβs expense, [*]. In such
event, the Indemnified Party shall keep the Indemnifying Party timely
apprised of the status of such Claim [*]. If the Indemnified Party defends
or handles such Claim, the Indemnifying Party [*], and shall be
[*].
|
Β
15.4
|
Mitigation of Loss. Each
Indemnified Party will take and will procure that its Affiliates take all
such reasonable steps and action as are necessary or as the Indemnifying
Party may reasonably require in order to mitigate any Claims (or potential
losses or damages) under this Article 15. Nothing in this Agreement shall
or shall be deemed to relieve any Party of any common law or other duty to
mitigate any losses incurred by it.
|
Β
15.5
|
Special, Indirect and Other
Losses. NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN
CONTRACT, TORT, NEGLIGENCE BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY
SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR FOR ANY ECONOMIC
LOSS OR LOSS OF PROFITS SUFFERED BY THE OTHER
PARTY[*].
|
Β
15.6
|
No Exclusion. Neither
Party excludes any [*].
|
Β
16.
|
PUBLICATIONS
AND PUBLICITY
|
Β
16.1
|
Use of Names. Neither
Party shall use the name, symbol, trademark, trade name or logo of the
other Party or its Affiliates in any press release, publication or other
form of public disclosure without the prior written consent of the other
Party in each instance (such consent not to be unreasonably withheld or
delayed), except for those disclosures for which consent has already been
obtained. Notwithstanding the foregoing, Novartis shall be entitled to use
the name of Quark to the extent necessary or useful in connection with the
Development or Commercialization of Products, including in connection with
sublicensing and subcontracting
transactions.
|
[ * ] = 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.
Β
57
Β
Β
16.2
|
Press Releases and Publicity
Related to this Agreement. Each Party agrees not to issue any press
release or other public statement, whether oral or written, disclosing the
existence of this Agreement, the terms hereof or any information relating
to this Agreement without the prior written consent of the other Party;
provided,
however,
that Novartis may issue press releases and other public statements as it
deems appropriate in connection with the Development and Commercialization
of Products under this Agreement, and that Quark may (with the prior
written consent of Novartis) issue press releases and other public
statements upon exercise of the Option by Novartis including the
applicable upfront payment described in Section 8.1 (without disclosing
any other financial amounts). When seeking the consent of Novartis, Quark
agrees to provide Novartis with at least [*] within which to grant or
withhold its consent. Novartis agree to consider in good faith Quarkβs
interest in seeing that significant development or commercial events under
this Agreement are promptly
disclosed.
|
Β
16.3
|
Public Disclosures and
Publications Related to Quark Compounds or Products.
|
Β
Β
|
(a)
|
Any
proposed public disclosure (whether written, electronic, oral or
otherwise) by Quark relating to any Quark Compounds or Product shall
require the prior written consent of Novartis; provided, that
the foregoing shall not apply to information which is in the public
domain.
|
Β
Β
|
(b)
|
For
the avoidance of doubt, Novartis or any of its Affiliates may, without any
required consents from Quark (i) issue press releases and other public
statements as it deems appropriate in connection with the Development and
Commercialization of Products under this Agreement; and (ii) publish or
have published information about clinical trials related to any Product,
including the results of such clinical
trials.
|
[ * ] = 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.
Β
58
Β
Β
16.4
|
Disclosures Required By
Law. Notwithstanding the provisions of Sections 16.2 and 16.3, each
Party may make any disclosures required of it to comply with any duty of
disclosure it may have pursuant to law or governmental regulation or
pursuant to the rules of any recognized stock exchange. In the event of a
disclosure required by law, governmental regulation or the rules of any
recognized stock exchange, the Parties shall coordinate with each other
with respect to the timing, form and content of such required disclosure.
If so requested by the other Party, the Party subject to such obligation
shall use commercially reasonable efforts to obtain an order protecting to
the maximum extent possible the confidentiality of such provisions
(including, without limitation, financial terms) of this Agreement as
reasonably requested by the other Party. If the Parties are unable to
agree on the form or content of any required disclosure, such disclosure
shall be limited to the minimum required as determined by the disclosing
Party in consultation with its legal counsel. Without limiting the
foregoing, each Party shall consult with the other Party on the provisions
of this Agreement, together with exhibits or other attachments attached
hereto, to be redacted in any filings made by Quark or Novartis with the
Securities and Exchange Commission (or other regulatory body) or as
otherwise required by law.
|
Β
16.5
|
No Liability for Public
Disclosures by Other Party. Nothing in this Agreement shall be
construed to impose upon either Party any liability or other obligation
(either to the other Party or to any other Person) with respect to any
press release, publication or other form of public disclosure or statement
of the other Party.
|
Β
17.
|
GENERAL
PROVISIONS
|
Β
17.1
|
Assignment. Neither
Party may assign its rights and obligations under this Agreement without
the other Partyβs [*], except that Novartis may without the consent of
Quark (a) assign its rights and obligations under this Agreement or any
part thereof to one or more of its Affiliates and (b) assign this
Agreement in its entirety to a successor to all or substantially all of
its business or assets to which this Agreement relates, and Quark may
without the consent of Novartis assign this Agreement in its entirety to a
successor to all or substantially all of its business or assets. The
assigning Party shall provide the other Party with prompt written notice
of any such assignment. Any permitted assignee shall assume all
obligations of its assignor under this Agreement (or related to the
assigned portion in case of a partial assignment to an Affiliate), and no
permitted assignment shall relieve the assignor of liability hereunder.
Any attempted assignment in contravention of the foregoing shall be void.
Subject to the terms of this Agreement, this Agreement shall be binding
upon and inure to the benefit of the Parties hereto and their respective
successors and permitted assigns. Notwithstanding anything to the contrary
herein, in the event that Quark is acquired by a Third Party, then the
intellectual property held, owned, controlled, or developed by such Third
Party prior to or as of such acquisition shall be excluded from Quark
Technology.
|
Β
17.2
|
Extension to
Affiliates.
Each Party shall have the right to extend the rights, immunities and
obligations granted in this Agreement to one or more of its Affiliates
(provided that in the case of Quark, such Affiliates shall be limited to
QBI Enterprises, Ltd., or any future Affiliates as to which Novartis
grants its written consent). All applicable terms and provisions of this
Agreement shall apply to any such Affiliate to which this Agreement has
been extended to the same extent as such terms and provisions apply to
such Party. Each Party shall remain primarily liable for any acts or
omissions of its Affiliates.
|
[ * ] = 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.
Β
59
Β
Β
17.3
|
Severability. Should one
or more of the provisions of this Agreement become void or unenforceable
as a matter of law, then this Agreement shall be construed as if such
provision were not contained herein and the remainder of this Agreement
shall continue in full force and effect. The Parties will use their
commercially reasonable efforts to substitute for the invalid or
unenforceable provision a valid and enforceable provision which conforms
as nearly as possible to the original intent of the
Parties.
|
Β
17.4
|
Governing Law and
Jurisdiction. This Agreement shall be governed by and construed
under the laws of [*],
without giving effect to the conflicts of laws provision thereof. Subject to
Section 17.5, any dispute arising out of or relating to this Agreement
shall be subject to the exclusive jurisdiction of the courts located in
[*].
|
Β
17.5
|
Dispute
Resolution.
|
Β
Β
|
(a)
|
In
the event of a dispute under this Agreement, either Party may require that
the Parties refer the dispute to the Alliance Managers for discussion and
resolution. If the Alliance Managers are unable to resolve any such
dispute within [*] of the dispute being referred to them, either Party may
require that the Parties forward the matter to the
Senior Officers (or designees with similar authority to resolve such
dispute), who shall attempt in good faith to resolve such dispute. If the
Senior Officers cannot resolve such dispute within [*] of the matter being
referred to them, either Party shall be free to initiate the arbitration
proceedings outlined in sub-Section (b)
below.
|
Β
Β
|
(b)
|
Any
unresolved disputes between the Parties relating to, arising out of or in
any way connected with this Agreement or any term or condition hereof, or
the performance by either Party of its obligations hereunder, whether
before or after termination of this Agreement, shall be resolved by final
and binding arbitration. Whenever a Party shall decide to institute
arbitration proceedings, it shall give written notice to that effect to
the other Party. Arbitration shall be held in New York, New York,
according to the Rules of Arbitration of the International Chamber of
Commerce (βICCβ).
The arbitration will be conducted in English by a panel of three
arbitrators appointed in accordance with ICC rules; provided that
each Party shall, within [*] after the institution of the arbitration
proceedings, appoint an arbitrator, and such arbitrators shall together,
within [*], select a third arbitrator as the chairman of the arbitration
panel. Each arbitrator shall have significant experience in the
pharmaceutical business. If the two initial arbitrators are unable to
select a third arbitrator within such [*] period, the third arbitrator
shall be appointed in accordance with ICC rules. Discovery shall be
governed by ICC rules, except that discovery shall be limited to: (i) the
production of documents in the producing Partyβs possession, not otherwise
available to the Party seeking the documents, that are [*] to [*] to the
[*]; (ii) [*] per side of a maximum of [*] (provided, however, that for
good cause shown, the arbitrators may authorize additional [*]); and (iii)
[*] per side. In addition, requests for production of documents shall
contain a description of specific documents or classes of documents, along
with [*]. The arbitrators may condition any exchange of documents subject
to claims of commercial or technical confidentiality on appropriate
measures to protect such confidentiality. When documents to be exchanged
are maintained in electronic form, the Party in possession of such
documents may make them available in the form (which may be paper copies)
most convenient and economical for it, unless the arbitrators determine,
on application and for good cause, that there is a compelling need for
access to the documents in a different form. The Party seeking the
production of documents shall ensure that [*] for [*] are [*] to make [*]
as [*]. The Parties shall request that the arbitrators render their
opinion within [*] of the final arbitration hearing. No arbitrator (nor
the panel of arbitrators) shall have the power to award punitive damages
under this Agreement and such award is expressly prohibited. Decisions of
the panel of arbitrators shall be final and binding on the Parties.
Judgment on the award so rendered may be entered in any court of competent
jurisdiction. The losing Party to the arbitration (if any) as determined
by the arbitrator shall pay the fees and costs of
arbitration.
|
[ * ] = 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.
Β
60
Β
Β
17.6
|
Force Majeure. Neither
Party shall be responsible to the other for any failure or delay in
performing any of its obligations under this Agreement, or for other
nonperformance hereunder, if such delay or nonperformance is caused by
strike, stoppage of labor, lockout or other labor trouble, fire, flood,
accident, war, act of terrorism, act of God or of the government of any
country or of any local government, or by cause unavoidable or beyond the
control of any Party hereto. In such event, the Party affected will use
commercially reasonable efforts to resume performance of its
obligations.
|
Β
17.7
|
Waivers and Amendments.
The failure of any Party to assert a right hereunder or to insist upon
compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure
to perform any such term or condition by the other Party. No waiver shall
be effective unless it has been given in writing and signed by the Party
giving such waiver. No provision of this Agreement may be amended or
modified other than by a written document signed by authorized
representatives of each Party.
|
Β
17.8
|
Relationship of the
Parties. Nothing contained in this Agreement shall be deemed to
constitute a partnership, joint venture, or legal entity of any type
between Quark and Novartis, or to constitute one as the agent of the
other. Moreover, each Party agrees not to construe this Agreement, or any
of the transactions contemplated hereby, as a partnership for any tax
purposes. Each Party shall act solely as an independent contractor, and
nothing in this Agreement shall be construed to give any Party the power
or authority to act for, bind, or commit the
other.
|
[ * ] = 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.
Β
61
Β
Β
17.9
|
Notices. All notices,
consents, waivers, and other communications under this Agreement must be
in writing and will be deemed to have been duly given when: (a) delivered
by hand (with written confirmation of receipt); (b) sent by fax (with
written confirmation of receipt), provided that a
copy is immediately sent by an internationally recognized overnight
delivery service (receipt requested); or (c) when received by the
addressee, if sent by an internationally recognized overnight delivery
service (receipt requested), in each case to the appropriate addresses and
fax numbers set forth below (or to such other addresses and fax numbers as
a Party may designate by notice):
|
Β
If to
Quark:
Β
Quark
Pharmaceuticals, Inc.
0000
Xxxxxxxxx Xxxxxx
Xxxxxxx,
XX 00000
X.X.X.
Attn:
Chief Executive Officer
Fax:
(000) 000-0000
Β
With a
copy to:
Β
Xxxxxx
LLP
Five Palo
Alto Square
0000 Xx
Xxxxxx Xxxx
Xxxx
Xxxx, XX 00000
U.S.A.
Attention:
Xxxxxx. X. Xxxxx
Fax:
(000) 000-0000
Β
If to
Novartis:
Β
Novartis
International Pharmaceutical Ltd.
000 Xxxxx
Xxxxxx
Xxxxxxxx
Xxxxxxx
XX 00
Attn:
General Counsel
Fax:Β
[*]
Β
with a
copy to:
Β
Xxxxxxxx
Xxxxxx XX
X.X.
Xxx
XX - 0000
Xxxxx
Switzerland
Attn:
Head, Legal Department
Fax:Β
[*]
[ * ] = 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.
Β
62
Β
Β
and
Β
Novartis
Pharma AG
X.X.
Xxx
XX - 0000
Xxxxx
Xxxxxxxxxxx
Attn:
Head, Business Development and Licensing
Fax:
[*]
Β
17.10
|
Further Assurances.
Novartis and Quark hereby covenant and agree without the necessity of any
further consideration, to execute, acknowledge and deliver any and all
such other documents and take any such other action as may be reasonably
necessary to carry out the intent and purposes of this
Agreement.
|
Β
17.11
|
Compliance with Law.
Each Party shall perform its obligations under this Agreement in
accordance with all applicable laws. No Party shall, or shall be required
to, undertake any activity under or in connection with this Agreement
which violates, or which it believes, in good faith, may violate, any
applicable law.
|
Β
17.12
|
No Third Party Beneficiary
Rights. The
provisions of this Agreement are for the sole benefit of the Parties and
their successors and permitted assigns, and they shall not be construed as
conferring any rights to any Third Party (including any third party
beneficiary rights).
|
Β
17.13
|
English Language. This
Agreement is written and executed in the English language. Any translation
into any other language shall not be an official version of this Agreement
and in the event of any conflict in interpretation between the English
version and such translation, the English version shall
prevail.
|
Β
17.14
|
Expenses. Except as
otherwise expressly provided in this Agreement, each Party shall pay the
fees and expenses of its respective lawyers and other experts and all
other expenses and costs incurred by such Party incidental to the
negotiation, preparation, execution and delivery of this
Agreement.
|
Β
17.15
|
Entire Agreement. This
Agreement, together with its Exhibits, sets forth the entire agreement and
understanding of the Parties as to the subject matter hereof and
supersedes all proposals, oral or written, and all other prior
communications between the Parties with respect to such subject matter. In
the event of any conflict between a substantive provision of this
Agreement and any Exhibit hereto, the substantive provisions of this
Agreement shall prevail.
|
Β
17.16
|
Counterparts. This
Agreement may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and
the same instrument.
|
[ * ] = 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.
Β
63
Β
Β
17.17
|
Antitrust Filings.
|
Β
Β
|
(a)
|
The
provisions of Section 4.2 of the Option Agreement shall apply to this
Agreement as if set forth in full in this
Agreement.
|
Β
Β
|
(b)
|
Other
than the provisions of this Section and Sections 1, 11, 16, 17.4, 17.5,
17.7-17.11, and 17.13-17.16, the rights and obligations of the Parties
under this Agreement shall not become effective until the waiting period
provided by the HSR Act shall have terminated or expired without any
action by any government agency or challenge to the transaction or any
other timeline required by another relevant agency or authority (the date
of such termination or expiration shall be the βLicense Effective Dateβ
of this Agreement). Β Upon the occurrence of the License Effective
Date, all provisions of this Agreement shall become effective
automatically without the need for further action by the
Parties.
|
Β
Β
|
(c)
|
In
the event that antitrust clearance from the FTC, Antitrust Division of the
Department of Justice or any other required agency or authority is not
obtained within [*] after the Execution Date, or such other date as the
Parties may mutually agree, this Agreement may be terminated by either
Party on written notice to the other.Β Β In the event a provision
of this Agreement needs to be deleted or substantially revised in order to
obtain regulatory clearance of this transaction, the Parties will
negotiate in good faith in accordance with Section
17.3.
|
Β
17.18
|
Cumulative
Remedies.Β Β No remedy referred to in this Agreement is
intended to be exclusive, but each shall be cumulative and in addition to
any other remedy referred to in this Agreement or otherwise available
under law.
|
[ * ] = 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.
Β
64
Β
Β
IN
WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to
be executed by their duly authorized representatives.
Β
NOVARTIS
INTERNATIONAL
PHARMACEUTICAL
LTD.
|
Β |
QUARK
PHARMACEUTICALS, INC.
|
||
Β | Β | Β | ||
By:
|
Β | Β |
By:
|
Β |
Β | Β | Β | Β | Β |
Name:
|
Β | Β |
Name:
|
Β |
Β | Β | Β | Β | Β |
Title:
|
Β | Β |
Title:
|
Β |
Β | Β | Β | ||
By:
|
Β | Β |
By:
|
Β |
Β | Β | Β | Β | Β |
Name:
|
Β | Β |
Name:
|
Β |
Β | Β | Β | Β | Β |
Title:
|
Β | Β |
Title:
|
Β |
[ * ] = 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.
Β
Β
65
Β
Β
EXHIBIT
A
Β
QUARK
PATENTS
Β
[*]
[ * ] = 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.
Β
66
Β
Β
EXHIBIT
B
Β
Form
of Sales & Royalty Report
Β
[*]
Β
[ * ] = 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.
Β
Β
67
Β
Β
EXHIBIT
C
Β
SAMPLE
INVOICE
Β
[*]
[ * ] = 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.
Β
Β
68
Β
Β
EXHIBIT
B
Β
DECISION
TREE FOR ILLUSTRATIVE PURPOSE ONLY
Β
[*]
Β
[ * ] = 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.
Β
35
Β
EXHIBIT
C
Β
AKI
PHASE II TRIAL PROTOCOL
Β
[*]
Β
[ * ] = 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.
Β
36
Β
Β
EXHIBIT
D
Β
[*]
Β
[ * ] = 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.
Β
37
Β
Β
EXHIBIT
E
Β
DGF
PHASE II TRIAL PROTOCOL
Β
[*]
Β
[ * ] = 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.
Β
38
Β
Β
EXHIBIT
F
Β
[*]
Β
[ * ] = 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.
Β
39
Β
Β
EXHIBIT
G
Β
QUARK
DEVELOPMENT PLAN
Β
[*]
Β
[ * ] = 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.
Β
40
Β
Β
EXHIBIT
H
Β
SAMPLE
INVOICE
Β
[*]
Β
[ * ] = 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.
Β
41
Β
Β
EXHIBIT
I
Β
PRESS
RELEASE
FOR
IMMEDIATE RELEASE
Quark
Pharmaceuticals, Inc.
Xxxxxxx
Xxxxxxxx
x000
00 00 0000
xxxxxxxxx@xxxxxxxxxxx.xxx
|
Β |
The
Xxxx Group (investors / media)
Xxxx
Xxxxxxxxxx / Xxxxx Xxxxx
(000)
000-0000 / 7025
xxxxxxxxxxx@xxxxxxxxxxxx.xxx
xxxxxx@xxxxxxxxxxxx.xxx
|
Quark
Pharmaceuticals and Major Pharmaceutical Company Enter into Licensing Option
Agreement for the p53 Suppressor Drug QPI-1002, the First siRNA Administered
Systemically in Human
Fremont,
CA August ____, 2010, β Quark Pharmaceuticals, Inc., a world leader in the
discovery and development of RNAi-based therapeutics, today announced that it
has granted Novartis an option to obtain an exclusive worldwide license to
develop and commercialize its p53 temporary inhibitor siRNA drug QPI-1002,
currently the subject of a Phase II clinical trial.
Quark
will receive initially a non-refundable fee of 10 million USD. In the event that
Novartis exercises the option, Quark would receive option exercise fees and
milestone payments that could potentially total 670 million USD. In addition
Quark would be entitled to potential royalties on sales of licensed products.
Xx. Xxxxxx Xxxx, Quarkβs Chief Executive Officer, stated, βWe are very pleased
to have reached this agreement with Novartis. We believe that Novartis
represents an outstanding partner for Quark. With its world-leading expertise in
transplantation and acute care Novartis will provide invaluable support to the
global development of QPI-1002, in development for the prevention of acute
kidney injury (AKI) in patients undergoing cardiac surgery and for delayed graft
function (DGF) in kidney transplant patients. The gene target of QPI-1002, p53,
is a major player in apoptotic cell death; its temporary suppression rescues
cells, prevents them from dying in conditions of severe stress such as ischemia,
potentially opening opportunities for Novartis to novel treatments in additional
indications.β
About
QPI-1002
QPI-1002
is designed to temporarily inhibit expression of the stress-response gene, p53
and is the first synthetic siRNA to be administered systemically to humans.
QPI-1002 is being developed for the prevention of acute kidney injury (AKI) in
patients undergoing major cardiovascular surgery, and for the prophylaxis of
delayed graft function (DGF) in patients receiving deceased donor kidney
transplants. QPI 1002 completed Phase I studies in these patient populations and
an independent Data Safety Monitoring Board recommended continuation of QPI-1002
clinical development in both diseases. QPI-1002 was granted Orphan designation
by the US Food and Drug Administration (FDA) and the European Medicines Agency
(EMA) for the prophylaxis of delayed graft function in kidney transplant
patients.
Β
[ * ] = 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.
42
Β
About
Quark Pharmaceuticals, Inc.
Quark
Pharmaceuticals, Inc., a world leader in novel RNAi discovery and development,
has the largest clinical-stage siRNA pipeline in the industry. The Companyβs
fully integrated drug development platform spans therapeutic target
identification to drug development. Quarkβs approach to delivery allows
targeting of tissues and organs including the eye, kidney, ear, lung, spinal
cord and brain.
In
addition to XXX-0000, Xxxxxβs pipeline includes PF-655, currently in two Phase
II clinical trials for the treatment of wet age-related macular degeneration
(AMD) and diabetic macular edema (DME). The siRNA therapeutic candidate PF-655
is licensed to Pfizer, who is conducting both trials in collaboration with
Quark. PF-655 targets Quarkβs proprietary gene, RTP801, discovered using its
BiFARβ’ target discovery platform that identifies clinically relevant critical
genes and proteins that reverse the disease phenotype when inhibited. The
Company owns a family of patents covering the RTP801 gene, its RNA and protein
product sequences, specific antibodies, and gene inhibition across different
pathologies. For the structure of these products, Quark has obtained licenses
from Silence Therapeutics and from Alnylam Pharmaceuticals.
Quark is
currently conducting clinical trials of QPI-1007, its proprietary synthetic
siRNA drug candidate for ocular neuroprotection. QPI-1007 utilizes a proprietary
structure developed in collaboration with BioSpring GmbH that provides Quark
with freedom to operate in the siRNA intellectual property arena and chemical
modifications that are designed to preserve RNAi activity while ameliorating
potential off-target and immunostimulatory effects of siRNAs.
Quark is
also committed to leveraging a broad research pipeline of siRNA drug candidates
and novel siRNA structures to develop additional RNAi drug
candidates.
Β
Quark is
headquartered in Fremont, California and operates research and development
facilities in Boulder, Colorado and Ness-Ziona, Israel. Additional information
is available at xxx.xxxxxxxxxxx.xxx
Β
[ * ] = 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.
Β
43
EXHIBIT
J
Β
TEMPLATE
FOR AKI FIRST INTERPRETABLE RESULTS
Β
[*]
Β
[ * ] = 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.
Β
Β
44
Β