PATENT LICENSE AGREEMENT
[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
Exhibit
10.33
This
Patent License Agreement
(“Agreement”)
is made and entered into as of the 29th day of January 2010 (the “Effective Date”) by
and between Dharmacon, Inc., a wholly owned subsidiary of Thermo Xxxxxx
Scientific, Inc., with a principal place of business at 0000 Xxxxxxxx Xxxxx,
#000, Xxxxxxxxx, XX 00000 (“Licensor”) and Quark
Pharmaceuticals, Inc., with a principal place of business at 0000 Xxxxxxxxx
Xxxxxx, Xxxxxxx, XX 00000 (“Quark”). Licensor
and Quark are each referred to herein individually as a “Party” and
collectively as the “Parties.”
RECITALS
WHEREAS
Licensor possesses certain expertise and proprietary technologies related to
siRNA molecule(s) as well as a pending patent application covering the
inhibition of the tumor protein 53 (“p53”) gene, which
Quark seeks to license exclusively from Licensor.
WHEREAS
Quark is a clinical-stage pharmaceutical company engaged in discovering and
developing novel therapeutic RNAi drug candidates and is engaged in clinical
trials with a particular siRNA oligonuclotide targeting the p53
gene.
WHEREAS,
Licensor and Quark wish to enter into an exclusive licensing arrangement whereby
Quark will have exclusive rights to develop and commercialize a particular siRNA
oligonucleotide targeting p53, covered by Licensor’s pending patent application,
in exchange for upfront, milestone and royalty payments.
NOW,
THEREFORE, in consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the amount and sufficiency of which are
hereby acknowledged, the Parties hereby agree as follows:
ARTICLE
1: DEFINITIONS
1.1 “Affiliate” means any
Person that, directly or indirectly (through one or more intermediaries)
controls, is controlled by, or is under common control with a
Party. For purposes of this Section 1.1, “control” means (i)
the direct or indirect ownership of fifty percent (50%) or more of the voting
stock or other voting interests or interest in the profits of the Party, or (ii)
the ability to otherwise control or direct the decisions of the board of
directors or equivalent governing body thereof.
1.2 “Applicable Laws”
means all applicable statutes, ordinances, regulations, rules, or orders of any
kind whatsoever of any government or regulatory authority, or court, of
competent jurisdiction.
1.3 “BLA” means a complete
biologics license application as defined in, and containing the content, and in
the format, required by 21 C.F.R. § 600 et seq
filed with the FDA, or a corresponding application with a Regulatory Authority
in a country other than the United States, together with all replacements,
additions, deletions, and supplements thereto.
1.4 “Business Day(s)”
means any day, other than a Saturday, Sunday or day on which commercial banks
located in San Francisco or Denver are authorized or required by law or
regulation to close.
1.5 “Calendar Quarter”
means the three month periods beginning on the first day of January, April, July
and October of each year.
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1.6 “Commercially Reasonable
Efforts” means the exercise of such efforts and commitment of such
resources by a Party as would be expended on, or committed by such Party to, a
comparable research, development or commercialization program of a similar scope
and at a similar stage in development or product lifecycle, comparable market
potential and market size, profit margin, competitive landscape, and risk
profile, in each case with due regard to the nature of efforts and cost required
for such research, development or commercialization and the current corporate
goals and priorities, but in any event, not less than the level of effort that
such Party uses to conduct its own comparable business, all as measured by the
facts and circumstances at the time such efforts are due.
1.7 “Confidential
Information” means (i) all information and materials (of whatever kind
and in whatever form or medium) disclosed by or on behalf of a Party to the
other Party (or its designee) in connection with this Agreement, including any
Know-How, whether prior to or during the term of this Agreement (including any
such information and materials disclosed pursuant to the Non-Disclosure
Agreement between the Parties dated [*]) and whether provided orally,
electronically, visually, or in writing; (ii) all copies of the information and
materials described in (i) above; and (iii) each of the terms and conditions of
this Agreement.
1.8 “Control(s)” or “Controlled” means the
possession by a Party, as of the Effective Date or during the term of this
Agreement, of (i) with respect to materials, data or information, physical
possession or the right to such physical possession of those items, with the
right to provide them to Third Parties; and (ii) with respect to intellectual
property rights, rights sufficient to grant the applicable license or sublicense
under this Agreement, without violating the terms of any agreement with any
Third Party.
1.9 “Covers” or “Covered by,” or the
like, with reference to a particular Licensed Product means that the making,
using, selling, offering for sale, or importing of such Licensed Product would,
but for ownership of, or a license granted under this Agreement to the relevant
Licensed Patent, infringe a Valid Patent Claim of the relevant Licensed Patent
in the country in which the activity occurs.
1.10 “Licensor Confidential
Information” means Confidential Information disclosed or provided by, or
on behalf of, Licensor to Quark or its designees.
1.11 “EMEA” means the
European Medicines Evaluation Agency or any successor thereto.
1.12 “Exclusive Field”
means the treatment, diagnosis or prevention of human diseases and
conditions.
1.13 “FDA” means the U.S.
Food and Drug Administration or any successor thereto.
1.14 “Filing” or “Filed” with respect
to an application for Marketing Approval means that such application has been
filed with and accepted for review by the appropriate Regulatory
Authority.
1.15 “First Commercial
Sale” means, with respect to a particular
Licensed Product in a given country, the first bona fide arms length commercial
sale of such Licensed Product following Marketing Approval in such country by or
under authority of Quark, its Affiliates or Sublicensee(s).
1.16 “GAAP” means the
United States Generally Accepted Accounting Principles consistently
applied.
1.17 “Good Laboratory
Practices” or “GLP” means the practices and procedures set forth in Xxxxx
00, Xxxxxx Xxxxxx Code of Federal Regulations, Part 58, and any other
regulations, guidelines or guidance documents relating to good laboratory
practices.
1.18 “IND” means a complete
“Investigational New
Drug Application” as defined in 21 C.F.R. 312.3 and containing the
content, and in the format, required by 21 C.F.R. 312.23, or a corresponding
application with a regulatory agency in a country other than the United States,
together with all additions, deletions, and supplements thereto.
1.19 “Indication” means any
human disease or condition, provided, however, for the purpose of this
definition, [*] shall be considered as [*].
[
* ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
2
1.20 “Know-How” means all
compositions of matter, techniques and data and other know-how and technical
information, including inventions (whether or not patentable), improvements and
developments, practices, methods, concepts, know-how, trade secrets, documents,
computer data, computer code, apparatus, clinical and regulatory strategies,
test data, analytical and quality control data, formulation, manufacturing,
patent data or descriptions, development information, drawings, specifications,
designs, plans, proposals and technical data and manuals and all other
proprietary information.
1.21 “p53 Patent
Application” means any patent application which contains one or more
claims which encompass the p53 Sequence or its use, including without limitation
the U.S. Patent application filed by Licensor on [*], [*], Serial No. [*], and
all foreign counterparts.
1.22 “p53 Sequence” refers
to an siRNA molecule or the oligonucleotides used to make such an siRNA that
includes the following sequence, [*] or its complement, including modifications
of the chemistry of such siRNA such as [*].
1.23 “Licensed Patent(s)”
means all patents (including without limitation divisions and continuations)
which contain one or more claims which encompass the p53 Sequence or its
use. Licensed Patent includes pipeline protection, invention certificates,
substitutions, reissues, reexaminations, extensions, registrations, patent term
extensions, supplementary protection certificates and renewals of any of the
above.
1.24 “Licensed Product”
means any molecule, composition or other product containing a native or
chemically modified siRNA oligomer that (i) includes the p53 Sequence and (ii)
is Covered by the Licensed Patent(s).
1.25 “Major European
Country” means the United Kingdom, France, Germany, Italy or
Spain.
1.26 “Major Market Country”
means the United States, Canada, Japan, and Member States of the European Union,
including without limitation the United Kingdom, France, Germany, Italy or
Spain.
1.27 “Marketing Approval”
means all approvals, licenses, registrations or authorizations of any federal,
state or local regulatory agency, department, bureau or other governmental
entity, necessary for the manufacturing, use, storage, import, transport,
marketing and sale of Licensed Products in a country or regulatory
jurisdiction. For countries where governmental approval is required
for pricing or reimbursement for the Licensed Product, “Marketing Approval”
shall not be deemed to occur until such pricing or reimbursement approval is
obtained.
1.28 “Net Sales” means the
gross amounts invoiced for sales of Licensed Products by Quark and its
Sublicensees (in final form for end use, but exclusive of inter-company
transfers), less the following deductions from such invoiced amounts which are
actually incurred or accrued:
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(a)
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credits
or allowances granted for Licensed Products that are damaged, returned,
rejected or recalled [*];
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(b)
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normal
and customary trade, cash and quantity
discounts;
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(c)
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sales
and excise taxes and duties (including value added taxes (VAT) and import
duties) paid or allowed by a selling party and any other governmental
charges imposed upon the manufacture or sale of a Licensed
Product;
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(d)
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chargebacks
and rebates, including those granted to managed health care organizations,
wholesalers, buying groups, retailers or to federal, state/provincial,
local and other governments, their agencies and purchasers and
reimbursers;
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
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(e)
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commissions
actually incurred or accrued for Third Parties (excluding sales personnel,
sales representatives and sales agents who are employees or consultants of
Quark, its Affiliates or their respective Sublicensees), in countries
where such commissions are
customary;
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(f)
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freight,
insurance, data, administrative, inventory management and nursing charges
or other fees related to the handling and distribution of Licensed
Products (to the extent not paid by the Third Party customer) and, with
respect to data, administrative, inventory management and nursing charges,
in countries where such charges are
customary;
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(g)
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credits
and allowances made for wastage replacement and indigent or similar
programs; and
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(h)
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reasonable
allowance for [*].
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All of
the foregoing elements of Net Sales calculations shall be determined on an
accrual basis in accordance with United States GAAP or applicable international
accounting standards.
Sales
between or among Quark and its Affiliates and Sublicensees shall be excluded
from the computation of Net Sales, but Net Sales shall include the first sales
to Third Parties (other than Sublicensee) by Quark or any such Affiliates or
Sublicensee. The supply of Licensed Products as samples, for use in
non-clinical or clinical studies, or for use in any tests or studies reasonably
necessary to comply with any Applicable Laws, regulation or request by a
regulatory or governmental authority or as is otherwise normal and customary in
the industry shall not be included within the computation of Net
Sales.
In the
event a Licensed Product is sold in combination with one or more other active
ingredients which are not Licensed Products under this Agreement (as used in
this definition of Net Sales, a “Combination”), then
for each Calendar Quarter payment period and on a country-by-country basis for
the remainder of this paragraph, the gross amount invoiced for that Licensed
Product shall be calculated by multiplying the gross amount invoiced for such
Combination by the fraction A/(A+B), where “A” is the gross amount invoiced for
the Licensed Product sold separately and “B” is the gross amount invoiced for
the other active ingredient(s) sold separately. In the event that the
other active ingredient is not sold separately, then the gross amount invoiced
for that Licensed Product shall be calculated by multiplying the gross amount
invoiced for the Combination by the fraction A/C, where “A” is the gross invoice
amount for the Licensed Product, if sold separately, and “C” is the gross
invoice amount for the Combination. In the event that a particular
Combination is not addressed by the foregoing, Net Sales for royalty
determination shall be determined by the Parties in good faith.
1.29 “Non-GLP Material”
means Licensed Product material that is not required to be produced in
compliance with Good Laboratory Practices.
1.30 “Person” means any
person or entity, including any individual, trustee, corporation, partnership,
trust, unincorporated organization, limited liability company, business
association, firm, joint venture or governmental agency or
authority.
1.31 “Phase II Clinical
Trial” means, as to a specific Licensed Product, a controlled and lawful
study in humans designed with the principal purpose of determining initial
efficacy and dosing of such Licensed Product in patients for the indication(s)
being studied, as further defined in 21 C.F.R. § 312.21(b); or similar clinical
study in a country other than the United States.
1.32 “Phase III Clinical
Trial” means, as to a specific Licensed Product, a controlled and lawful
study in humans of the efficacy and safety of such Licensed Product, which is
prospectively designed to demonstrate statistically whether such Licensed
Product is effective and safe for use in a particular indication in a manner
sufficient to file an application to obtain Marketing Approval to market and
sell that Licensed Product in the United States or another country for the
indication being investigated by the study, as further defined in 21 C.F.R. §
312.21; or similar clinical study in a country other than the United
States.
[
* ] = 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.
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1.33 “Quark Confidential
Information” means Confidential Information disclosed or provided by, or
on behalf of, Quark to Licensor or its designees.
1.34 “Regulatory Authority”
means any national (e.g., the FDA or
corresponding governmental authority in another country), supra-national (e.g., the EMEA), regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity, in any jurisdiction of the world, involved in the
granting of Marketing Approval.
1.35 “Research Field” means
all research and development activities related to designing, generating,
researching and developing pharmaceutically active substances, which substances
are based on Licensed Product.
1.36 “siRNA” means a small
interfering ribonucleic acid.
1.37 “Sublicensee(s)” means
any Third Party that enters into an agreement with Quark or an Affiliate of
Quark involving the grant to such Third Party of a right to make, use, sell,
offer for sale or import a Licensed Product or a sublicensee under any of the
licenses granted to Quark hereunder, subject to Section 3.6
herein.
1.38 “Target” means the
deoxyribonucleic acid or ribonucleic acid sequence from which a molecule of
ribonucleic acid produced by an organism, including but not limited to humans
and pathogens, is or could be transcribed.
1.39 “Territory” means the
entire world.
1.40 “Third Party” means a
Person that is not a Party to this Agreement or an Affiliate of a Party to this
Agreement.
1.41 “United States” means
the United States of America, its territories and possessions as of the
Effective Date, including the Commonwealth of Puerto Rico.
1.42 “Valid Patent Claim”
means a claim of an issued and unexpired Licensed Patent which has not been
disclaimed, revoked, held unenforceable or invalid by a decision of a court or
other governmental agency of competent jurisdiction, unappealable or unappealed
within the time allowed for appeal, and which has not been admitted to be
invalid or unenforceable through reissue or disclaimer or
otherwise.
ARTICLE
2: DEVELOPMENT AND COMMERCIALIZATION EFFORTS
2.1 Development and
Commercialization Responsibilities.
2.1.1 Exclusive Quark
Right. As between the Parties, Quark (and, if applicable,
Sublicensees) have the sole right and responsibility for, and control over, all
research, development, manufacturing and commercialization activities, including
all regulatory activities, with respect to any Licensed Products.
2.1.2 Development
Costs. Except as otherwise agreed to by the Parties, Quark
(and/or Sublicensee) shall bear all costs and expenses associated with research,
development, manufacturing and commercialization activities with respect to
Licensed Products.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
5
2.1.3 Development
Updates. Throughout the Term, Quark shall provide to Licensor
periodic updates on the plan for development of Licensed Products under this
Agreement on at least [*] basis. Such updates to include a summary of
any significant progress or advances along with a general description of Quark’s
then-current plan of development of Licensed Products. It is
understood and agreed that the development plan summaries provided under this
Section 2.1.3
are non-binding and provided to Licensor for informational purposes
only.
2.2 Quark
Diligence. Quark shall use Commercially Reasonable Efforts to
develop and commercialize at least one Licensed Product directed towards a
Target as indicated by [*] and [*]. Activities by Sublicensees and
Affiliates will be considered as Quark’s activities under this Agreement for
purposes of determining whether Quark has complied with its obligations under
this Section
2.2. Notwithstanding anything to the contrary, any failure by
Quark to meet its diligence obligations under this Section 2.2 shall not
be considered a material breach of this Agreement by Quark to the extent that
such failure was caused by any act, delay, omission or failure by Licensor in
the performance of any of its obligations under this Agreement. Not
more frequently than once each [*], Licensor may request a written update
summarizing Quark’s activities towards the development and commercialization of
Licensed Products. Within [*] following receipt of such written
request, Quark shall provide a written summary of Quark’s development and
commercialization activities with respect to the Licensed Products during the
prior [*] period.
2.3 Development of Licensed
Products.
2.3.1 Generally. The
Parties intend and agree that filing for any IND, Marketing Approval or other
filing with a Regulatory Authority and commercialization of Licensed Products
shall be controlled by Quark. Without limiting the generality of the
foregoing, Quark shall be responsible for making and have authority to make all
decisions, and undertake any actions necessary as a result of such decisions,
regarding development (including additional preclinical and clinical development
and testing), selecting drug candidates and preparing and filing BLAs and any
other applications for Marketing Approval. Quark shall own all
regulatory submissions, including all Marketing Approvals and applications
therefor, for Licensed Products in the Territory.
2.3.2 Cooperation. Upon
Quark’s written request, Licensor shall and shall cause its employees,
contractors and agents to cooperate with and provide reasonable support to Quark
in its conduct of any activities in the research, development, manufacturing and
commercialization, including seeking of Marketing Approval of Licensed
Products. Without limiting the generality of the foregoing, Licensor
shall assist Quark and any Sublicensee, in each case upon Quark’s or its
Sublicensee’s request, in the preparation and filing of any applications for
Marketing Approval with respect to Licensed Products, including by delivering
all information in Licensor’s Control necessary or useful to complete and file
any Marketing Approval for a Licensed Product in the Territory. Quark
shall reimburse Licensor for any expenses reasonably incurred by Licensor in
connection with such cooperation and support provided that such expenditures are
approved in advance by Quark.
2.3.3 Transfer of Information and
Regulatory Filings. Within [*] of written request by Quark,
Licensor agrees to disclose to Quark all Know-How, including any preclinical
data, assays and associated materials, protocols, reports, procedures and any
other information owned of Controlled by Licensor, if any, necessary or useful
to continue or initiate pre-clinical or clinical development, or in seeking
Marketing Approval, of Licensed Products.
2.3.4 Manufacturing and
Supply. Except as expressly set forth in this Section 2.3.4, Quark
shall be responsible for manufacturing Licensed Products for clinical use and
commercial sale in the Exclusive Field.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
6
(a) Supply of Non-GLP
Material. In the first instance that supply of Non-GLP
Material in quantities [*] is sought by Quark, Quark shall notify Licensor of
its requirements (“Supply
Notice”). If Licensor replies to such notice in writing within
[*] following the date of Quark’s Supply Notice with a proposal for supplying
such Non-GLP Material, the Parties shall negotiate in good faith for a period of
[*]. If the Parties are unable to reach agreement on the terms of
such Non-GLP Material supply within such [*] period, Quark may contract with a
Third Party to supply such Non-GLP Material. For clarity, this Section 2.3.4(a)
shall only apply the first time that Quark seeks a supply of Non-GLP Material in
quantities [*], and Quark has no obligation to provide Licensor a Supply Notice
or to otherwise notify or negotiate any supply agreement with Licensor for
Non-GLP Material after the first instance of Quark seeking Non-GLP Material in
quantities [*].
ARTICLE
3: LICENSE GRANTS, RESERVED RIGHTS
3.1 Exclusive
License. Subject to the terms and conditions of this Agreement
including Section
3.4, Licensor hereby grants to Quark an exclusive right and license under
the Licensed Patent(s) to make, have made, use (including the right to develop),
sell, offer for sale and import Licensed Products in the Exclusive Field in the
Territory. The license granted to Quark in this Section 3.1 shall
include the right to sublicense to a Third Party in accordance with the terms
set forth in this Agreement.
3.2 Non-Exclusive Research
License. Subject to the terms and conditions of this
Agreement, Licensor hereby grants to Quark a non-exclusive, non-sublicensable
(except as expressly provided in this Section 3.2) right
and license under the Licensed Patent(s) to make, have made and use (including
the right to develop) Licensed Products in the Territory in the Research Field
during the Term, solely for Quark to exercise its research and development
rights under this Agreement. For clarity, the foregoing license grant
shall expressly include the right of Quark to authorize, by sublicense or
otherwise, Third Party contractors and/or collaborators to exercise the rights
granted to Quark in this Section 3.2 for the
limited purpose of conducting research activities on behalf of and for the
benefit of Quark.
3.3 Retention of
Rights. Notwithstanding anything in this Agreement to the
contrary but otherwise in accordance with this Section 3.3, Licensor
will retain the rights to (a) use Licensed Products for Licensor’s internal
research purposes outside the Exclusive Field; (b) use Licensed Products for
Licensor’s commercial or research screening assay services purposes for itself
or Third Parties outside the Exclusive Field; and (c) use, develop, sell,
distribute or otherwise commercialize Licensed Product(s) or Licensed Patent
outside the Exclusive Field (including selling native or modified siRNA that may
comprise a Licensed Product as part of Licensor’s research reagent product
offerings (e.g.,
standard SMARTpool® reagents), solely for research purposes and solely outside
the Exclusive Field). For the avoidance of doubt, Licensor’s retained
rights outside the Exclusive Field do not include the right to conduct clinical
development of Licensed Product; rather the right to conduct clinical
development of Licensed Product is solely within the Exclusive Field and
reserved for Quark.
3.4 Exclusivity;
Restrictions. During the Term, the
Parties agree that Quark shall have the sole right to develop and commercialize
Licensed Products in the Exclusive Field, and Licensor shall not grant to any
Third Party or Affiliate any rights to research, develop or commercialize
Licensed Products for any purpose, subject to Section
3.3. Except as allowed in Section
3.3, Licensor shall not
provide any Licensed Products to any Third Party or
Affiliate. Further, Licensor shall not collaborate with or otherwise
provide to any Third Party or Affiliate any methods of identifying or making any
Licensed Products.
3.5 No Implied
Licenses. Each Party acknowledges that the licenses granted
under this Article
3 are limited to the scope expressly granted, and all other rights under
a Party’s patents and other intellectual property rights are expressly reserved
to the granting Party. Where a license is granted by one Party to the
other Party under this Article 3 for a
particular purpose or with respect to a particular product, the granting Party
retains all of its rights with respect to those intellectual property rights for
those purposes not expressly licensed under this Agreement.
3.6 Sublicenses. Quark
may grant one or more sublicenses hereunder without the prior consent of
Licensor, provided that (i) each Sublicensee shall agree to be bound by all of
the relevant obligations, terms and conditions that obligate or bind Quark under
Sections [*] of
this Agreement and the applicable sublicense agreement must be consistent with
the terms and conditions herein; (ii) Quark shall be and remain responsible for
the performance by each Sublicensee of all of such Sublicensee’s obligations
provided hereunder; (iii) Quark shall continue to remain liable for all
liabilities and obligations under this Agreement, including the payment
obligations set forth in Article 4, and (iv)
Quark is responsible for compliance by its Sublicensees with the terms and
conditions of this Agreement and the applicable sublicense agreement, including
the diligence obligations set forth in Section
2.2.
[ * ] = 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.
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3.7 Sublicense
Fee. In the event that Quark grants a sublicense under the
Licensed Patent(s) to make, have made, use (including the right to develop),
sell, offer for sale or import Licensed Products in the Exclusive Field in the
Territory, Quark will pay Licensor, in accordance with the table below, an
amount equal to a specified percentage of any Sublicense Income received by
Quark. For clarity, any payment made by Quark in accordance with this
Section 3.7
shall be in addition to payments made by Quark to Licensor in accordance with
Article
4.
[*] at time when Quark receives
Sublicense Income
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Percentage of Sublicense Income to
be Paid to Licensor
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[*]
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[*]%,
provided that such amount accrues as Sublicense Income is received by
Quark but is paid by Quark to Licensor only after [*], provided that
[*]
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[*]
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[*]%
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[*]
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[*]%
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“Sublicense Income”
means any gross amount of consideration received by Quark or an Affiliate,
directly from granting such sublicense (including without limitation up-front
fees and milestone payments) provided that the following shall be excluded from
Sublicense Income: (i) royalties on Net Sales of the Licensed Product, (ii) fees
for research and development of the Licensed Product, such as clinical trial
support and/or any other goods and/or services provided by Quark to a
Sublicensee with respect to the Licensed Product, (iii) profit-sharing payments
arising from the commercialization of Licensed Product, (iv) payments for equity
or debt securities of Quark (except to the extent such payments exceed the fair
market value of such securities at the time of sale) received by Quark for the
Licensed Product, and (v)
fees or payments to the extent that Quark has a contractual obligation to a
Sublicensee to perform future research and development of the Licensed Product
and Quark later actually incurs costs (internal and/or external) performing such
contractually obligated research and development without separate reimbursement
from the Sublicensee.
For
further clarity, Quark agrees that it shall neither [*] (assuming that [*]) nor
[*] (assuming [*]), except to the extent that [*] at the time Quark is obligated
to make a payment to Licensor under this Section
3.7.
ARTICLE
4: PAYMENTS
4.1 License
Fee. In consideration for the rights granted and promises made
hereunder, including the license granted to Quark under the Licensed Patent(s),
Quark shall, within [*] of the Effective Date, pay to Licensor a one-time,
nonrefundable and noncreditable payment of [*]. In addition, within
[*], Quark shall pay Licensor a one-time, nonrefundable and noncreditable
payment of [*].
[ * ] = 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.
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4.2 Milestone
Payments.
4.2.1
Within [*] following the first Licensed Product to achieve the milestones
(“Milestones”),
Quark shall pay Licensor the amounts set forth herein below.
|
(i)
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[*] upon
[*]
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(ii)
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[*] upon
[*]
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(iii)
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[*] upon
[*]
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(iv)
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[*] upon
[*]
|
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(v)
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[*] upon
[*]
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(vi)
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[*] upon
[*]
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(vii)
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[*] upon
[*]
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(viii)
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[*] upon
[*]
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(ix)
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[*] upon
[*]
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(x)
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[*] upon
[*]
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(xi)
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[*] upon
[*]
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(xii)
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[*] upon
[*]
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(xiii)
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[*] upon
[*]
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(xiv)
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[*] upon
[*]
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(xv)
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[*] upon
[*]
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(xvi)
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[*] upon
[*]
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Milestone
payments pursuant to this Section 4.2 shall be
non-refundable and non-creditable against any future payments.
4.3 Licensed Product Earned
Royalties. In consideration for the rights granted hereunder,
in each Calendar Quarter during the Term of this Agreement in which Quark or its
Sublicensee(s) records Net Sales of a Licensed Product where such sale in such
country is Covered by a Valid Patent Claim within the Licensed Patent(s), and
subject to and in accordance with the terms and conditions of this Agreement,
Quark shall pay to Licensor, on a Licensed Product-by-Licensed Product and
country-by-country basis, an amount equal to [*] of annual Net Sales up to
[*] of Licensed Products and an amount equal to [*] of annual Net Sales
above [*] of Licensed Products. All payments due under
this Section
4.3 shall be paid in quarterly installments and shall be paid within [*]
following the end of each Calendar Quarter.
4.4 Deductions from
Payments. If in Quark’s reasonable business judgment it is
necessary to obtain, or if Quark has already obtained as of the Effective Date,
a license from a Third Party in connection with the research, development,
manufacture, distribution, use, sale, import or export of a Licensed Product,
Quark shall have the right to set off up to [*] any amounts paid to such Third
Party(ies) against the royalties payable pursuant to Sections 4.3;
provided, that in no event will the aggregate off-set permitted under this Section 4.4 reduce
the royalty rate for royalties that would otherwise be due during a particular
reporting period below a net royalty rate of [*] for annual Net Sales up
to [*] and [*] for
annual Net Sales above [*], regardless of the number of Third Party payments
included in such off-set.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
9
4.5 Additional Royalty
Terms.
4.5.1 Single
Royalty. Notwithstanding anything herein to the contrary, with
respect to any Licensed Product only a single royalty payment shall be due and
payable, regardless if such Licensed Product is covered by more than one Valid
Patent Claim or contains more than one component Covered by a Valid Patent
Claim.
4.5.2 Royalty Term; Fully Paid
Licenses. Royalties under this Article 4 are payable
only during time periods in which [*] the applicable Licensed Product is Covered
by a Valid Patent Claim within the Licensed Patent(s) in the applicable country
of sale. For further clarity, [*] for Licensed Product that is [*] in
a country where there is no Valid Patent Claim. Upon expiration of
the last Valid Patent Claim within the Licensed Patent(s) Covering the sale of a
Licensed Product in a given country, the licenses granted to Quark under this
Agreement with respect to such Licensed Product in such country shall become
fully paid and irrevocable.
ARTICLE
5: REPORTS, AUDITS AND FINANCIAL TERMS
5.1 Royalty Reports.
Within [*] after the end of each Calendar Quarter in which a royalty payment
under Article 4
is required to be made, Quark shall send to Licensor a report of Net Sales of
the Licensed Products for which a royalty is due, which report sets forth for
such Calendar Quarter the following information: (i) total Net Sales
of all Licensed Products sold in the Territory during such Calendar Quarter,
(ii) Net Sales on a country-by-country basis and (iii) the total royalty
payments due. Each royalty report shall be certified by an officer of Quark, or
a responsible person within Quark’s accounting department, to be correct to the
best of its knowledge and information.
5.2 Additional Financial
Terms.
5.2.1 Currency. All
payments to be made under this Agreement shall be made in United States
dollars. Amounts invoiced in a currency other than dollars must be
expressed in the United States dollar equivalent as well as any local
currency. Net Sales outside of the United States shall be first
determined in the currency in which they are earned and shall then be converted
into an amount in United States dollars. All currency conversions
shall use the conversion rate reported by the last print edition of Reuters,
Ltd. on the last Business Day of the Calendar Quarter for which such payment is
being determined.
5.2.2 Payment
Type. Amounts paid by one Party to the other under this
Agreement shall be paid in U.S. dollars, in immediately available funds, by
means of wire transfer to an account identified by the payee.
5.2.3 Withholding of
Taxes. Each Party may withhold from payments due to the other
Party amounts for payment of any withholding tax that is required by law to be
paid to any taxing authority with respect to such payments. The Party
withholding the tax shall provide to the other Party all relevant documents and
correspondence, and shall also provide to the Party from whose payment that tax
was withheld any other cooperation or assistance on a reasonable basis as may be
necessary to enable that Party subject to withholding to claim exemption from
such withholding taxes and to receive a full refund of such withholding tax or
claim a foreign tax credit. The Party withholding the tax shall give
proper evidence from time to time as to the payment of such tax. The
Parties shall cooperate with each other in seeking deductions under any double
taxation or other similar treaty or agreement from time to time in
force. Such cooperation may include Quark making payments from a
single source in the U.S., where possible.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
10
5.2.4 Late
Payments. Any undisputed amounts not paid within [*] after the
date due under this Agreement are subject to interest from the date due through
and including the date upon which payment is received. Interest is
calculated, over the period between the date due and the date paid, at a rate
equal to [*] the “bank prime loan” rate, as such rate is published in the U.S.
Federal Reserve Bulletin H.15 or successor thereto on the last Business Day of
the applicable Calendar Quarter prior to the date on which such payment is due,
or the maximum rate permitted by Applicable Law, if less.
5.2.5 Blocked
Currency. If, at any time, legal restrictions prevent the
prompt remittance of part or all royalties with respect to any country where a
Licensed Product is sold, payment shall be made through such lawful means or
methods as the Party paying may determine. When in any country, the
law or regulations prohibit both the transmittal and deposit of royalties or
other payments, the Party paying shall continue to report all such amounts, but
may suspend payment for as long as such prohibition is in effect. As
soon as such prohibition ceases to be in effect, all amounts that would have
been obligated to be transmitted or deposited, but for the prohibition, shall
forthwith be deposited or transmitted promptly.
5.3 Accounts and
Audit.
5.3.1 Records. Quark
shall keep, and shall require its Affiliates and all Sublicensees to keep, full,
true and accurate books of account containing the particulars of Net Sales and
the calculation of royalties. Quark shall keep such books of account
and the supporting data and other records at its principal place of
business. Such books and records must be maintained available for
examination in accordance with this Section for [*] after the end of the
calendar year to which they pertain, and otherwise as reasonably required to
comply with GAAP.
5.3.2 Appointment of
Auditor. Licensor may appoint an internationally-recognized
independent accounting firm reasonably acceptable to Quark to inspect the
relevant books of account of Quark to verify any reports or statements provided,
or amounts paid or invoiced (as appropriate), by Quark. The
independent accounting firm (and any individuals, if applicable) appointed to
perform the examination under this Agreement must execute a confidential
disclosure agreement with Quark, or otherwise be subject to terms governing
non-use and non-disclosure of information that Quark has agreed in writing are
acceptable.
5.3.3 Procedures for
Audit. Licensor may exercise its right to have Quark’s
relevant records examined no more than [*] in any [*] period. Quark
is required to make its records available for inspection only during regular
business hours, only at such place or places where such records are customarily
kept, and only upon receipt of at least [*] written advance notice from
Licensor.
5.3.4 Audit
Report. The independent accountant will be instructed to
provide an audit report containing its conclusions regarding the audit, and
specifying whether the amounts paid were correct, and, if incorrect, the amount
of any underpayment or overpayment. The independent accountant
further will be instructed to provide that audit report first to Quark, and will
be further instructed to redact any proprietary information of Quark not
relevant to the calculation of royalties prior to providing that audit report to
Quark. That audit report shall be deemed to be Confidential
Information of Quark, and used only for purposes germane to this
Section.
5.3.5 Underpayment and
Overpayment. After review of the auditor’s report: (i) if
there is an uncontested underpayment by Quark for the period in question, then
Quark shall pay to Licensor the full amount of that uncontested underpayment,
and (ii) if there is an uncontested overpayment by Quark for the period in
question, then Licensor shall provide to Quark a credit against future payments
(such credit equal to the full amount of that overpayment), or, if Quark is not
obligated to make any future payments, then Licensor shall pay to Quark the full
amount of that overpayment. Contested amounts are subject to dispute
resolution under Article
12. If the total amount of any underpayment (as agreed to by
Quark or as determined under Article 12) exceeds
[*] of the amount previously paid by Quark for the period subject to audit (as
long as that period is [*]), then Quark shall pay the reasonable costs for the
audit.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
11
ARTICLE
6: INTELLECTUAL PROPERTY; PATENT PROSECUTION AND
MAINTENANCE
6.1 Patent Prosecution and
Maintenance.
6.1.1 Definition. For
purposes of this Section 6.1.1,
“Prosecution and
Maintenance” or “Prosecute and
Maintain,” with regard to a particular patent application or patent,
means the preparation, filing, prosecution and maintenance of such patent
application or patent, as well as re-examinations, reissues, applications for
patent term extensions and the like with respect to that patent, together with
the conduct of interferences, the defense of oppositions and other similar
proceedings with respect to that patent.
6.1.2 Prosecution and Maintenance
of p53 Patent Application and Licensed Patent(s). As between
the Parties, Licensor shall, at its sole expense and using commercially
reasonable efforts, have the right to Prosecute and Maintain the p53 Patent
Application and Licensed Patent(s) and Quark shall reasonably cooperate with
such Prosecution and Maintenance. With respect to the p53 Patent
Application, Licensor shall (i) keep Quark reasonably informed as to the
Prosecution (including determining in which countries to initiate or continue
prosecution) such that Quark has sufficient time to review and comment upon any
documents intended for submission to any patent office; (ii) promptly furnish to
Quark a copy of any patent application and copies of documents relevant to such
Prosecution, including copies of correspondence with any patent office, foreign
associates, and outside counsel; and (iii) reasonably consider and incorporate
comments of Quark on documents filed with any patent office.
6.1.3 Costs. Unless
otherwise mutually agreed by the Parties, during the Term of this Agreement,
Quark shall reimburse Licensor for all fees and costs (including without
limitation attorneys’ fees) reasonably incurred by Licensor after the Effective
Date of this Agreement for Prosecution and Maintenance of the P53 Patent
Application and Licensed Patent(s). Quark shall reimburse Licensor for such fees
and costs covered by this Section 6.1.3 within
[*] following receipt of an itemized invoice from Licensor for
same.
6.1.4 Foreign
prosecution. Licensor will, at the request of Quark, file,
prosecute and maintain foreign counterparts of the p53 Patent
Application. The Parties shall discuss the countries in which the
Licensed Product may be sold in order to determine whether patent protection may
and should be sought in such countries.
6.2 Patent Challenge. Licensor shall have the right, to the extent permitted by law, to terminate this
Agreement by written notice to Quark, effective upon receipt, if Quark, or its
Affiliate or Sublicensee(s) commences any interference, opposition or
reexamination proceeding, challenges the validity or enforceability
of, or opposes any extension of the grant of a supplementary protection
certificate with respect to any Licensed Patent (“Patent Challenge”). Quark agrees to make any Sublicensee aware
of this provision and of Licensor’s right to
terminate this Agreement upon any Patent
Challenge.
6.3 Patent Marking. Quark agrees to xxxx the Licensed Products
sold in the United States with all applicable United States patent
numbers. All Licensed Products shipped to or sold in other countries
shall be marked permanently and legibly in
such a manner as to conform to the patent laws and practice of the country of
manufacture or sale and to preserve Licensor’s patent rights in
such countries.
ARTICLE
7: ENFORCEMENT OF IP RIGHTS;
DEFENSE
OF THIRD PARTY INFRINGEMENT CLAIMS
7.1 Infringement
Action.
7.1.1 Action by
Licensor. Subject to Section 7.1.1, as
between the Parties, Licensor shall have at its own cost the sole right, but not
the obligation, to seek to xxxxx any actual or suspected infringement of the
Licensed Patent by a Third Party outside of the Exclusive Field, or to file suit
against any such Third Party. Quark shall cooperate with Licensor (as
may be reasonably requested by Licensor), including, if necessary, by being
joined as a party.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
12
7.1.2 Action by
Quark. Quark or its Sublicensee shall have at its own cost the
first right, but not the obligation, to seek to xxxxx any actual or suspected
infringement of the Licensed Patent in the Exclusive Field in the Territory by a
Third Party but only insofar as such actual or suspected infringement relates to
a Licensed Product, or to file suit against any such Third
Party. Licensor shall cooperate with Quark or its Sublicensee (as may
be reasonably requested by Quark or its Sublicensee), including, if necessary,
by being joined as a party. If neither Quark nor its Sublicensee
commences an infringement action against the alleged or threatened infringement
within [*] of the notice of such alleged or threatened infringement, then
Licensor may commence litigation with respect to the alleged or threatened
infringement at its own expense; provided, that Licensor shall not initiate such
litigation if Quark or its Sublicensee, as applicable, in its reasonable
judgment determines that enforcement of such patent rights would have a material
adverse effect on the development, commercialization, or commercial value of
Licensed Products pursuant to this Agreement.
7.2 Settlement. Neither
Quark nor its Sublicensee, as applicable, may settle or consent to an adverse
judgment in any action described in Section 7.1, without
the express written consent of Licensor (such consent not to be unreasonably
withheld), except that Quark or its Sublicensee may settle or consent to an
adverse judgment to any action described in Section 7.1 without
Licensor’s consent to the extent such settlement or consent judgment does not
(i) impose a financial obligation on Licensor or (ii) result in a reduction of
the royalty income for Licensor, except to the extent otherwise provided in
accordance with Section
4.4.
7.3 Damages. Unless otherwise
mutually agreed by the Parties, and subject to the respective indemnity
obligations of the Parties set forth in Article 10, all
monies recovered upon the final judgment or settlement of any action described
in Section 7.1,
shall be used: (i) first, to reimburse each of Quark (or its Sublicensee) and
Licensor, on a pro
rata basis for its
out-of-pocket expenses relating to the action; (ii) second, any remaining
balance that represents compensation for lost sales, a reasonable royalty or
lost profits, shall be [*]; and (iii) third, any remaining amount that
represents additional damages (for example, enhanced or punitive damages) shall
be [*].
7.4 Third Party
Suits. In the event that a Third Party shall make any claim or
bring any suit or other proceeding against Quark, or any of its Affiliates,
Sublicensees or customers, for infringement or misappropriation of any
intellectual property rights with respect to the research, development, making,
using selling, offering for sale, import or export of any Licensed Product,
Quark or its Sublicensee shall have the right to defend and control the defense
of such claim, suit or other proceeding as well as to initiate and control any
counterclaim or other similar action at its own cost and
expense. Licensor shall fully cooperate with Quark or its
Sublicensee, as applicable, in defense of such claim, suit or other proceeding,
including by being joined as a party. Unless otherwise mutually
agreed by the Parties, and subject to the respective indemnity obligations of
the Parties set forth in Article 10, the
provisions of Sections
7.2 and 7.3 shall apply to any proceeding covered by this Section 7.4, except
that the negotiation of any license from the Third Party shall be subject to
Section
4.4.
ARTICLE
8: TERM AND TERMINATION
8.1 Term. The
term of this Agreement (the “Term”) shall commence
on the Effective Date and, unless sooner terminated by mutual agreement or
pursuant to any other provision of this Agreement, shall terminate on the date
on which all obligations under this Agreement between the Parties with respect
to the payment of milestones or royalties with respect to Licensed Products have
passed or expired.
8.2 Termination.
8.2.1 Material
Breach. Either Party may terminate this Agreement for any
material breach by the other Party, provided that the terminating Party gives
the breaching Party written notice of such breach and the breach remains uncured
after the expiration of [*] after such written notice was given. Notwithstanding
anything to the contrary herein, if the allegedly breaching Party in good faith
either disputes (i) whether a breach is material or has occurred or (ii) the
alleged failure to cure or remedy such material breach, and provides written
notice of that dispute to the other Party within the above time periods, then
the matter will be addressed under the dispute resolution provisions in Article 12, and the
notifying Party may not terminate this Agreement until it has been determined
under Article
12 that the allegedly breaching Party is in material breach of this
Agreement, and such breaching Party further fails to cure such breach within [*]
after the conclusion of that dispute resolution procedure. Further,
where the material breach giving the right to terminate is a failure to pay
amounts due with respect only to a particular Licensed Product, the terminating
Party may terminate this Agreement only with respect to the particular Licensed
Product that is the subject of the breach (i.e., exclude that Licensed
Product from the scope of the licenses granted to the breaching Party) and may
not terminate the Agreement in its entirety.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
13
8.2.2 Bankruptcy. Quark
shall have the right to terminate this Agreement upon written notice to
Licensor, in the event that Licensor seeks protection of any bankruptcy or
insolvency law, a proceeding in bankruptcy or insolvency is filed by or against
Licensor and is not dismissed within [*], or there is an adjudication by a court
of competent jurisdiction that Licensor is bankrupt or insolvent. Licensor shall
have the right to terminate this Agreement upon written notice to Quark, in the
event that Quark seeks protection of any bankruptcy or insolvency law, a
proceeding in bankruptcy or insolvency is filed by or against Quark and is not
dismissed within [*], or there is an adjudication by a court of competent
jurisdiction that Quark is bankrupt or insolvent. Notwithstanding the
foregoing, if Quark has granted any sublicense that is in effect at the time
that this Agreement would otherwise be terminated by Licensor pursuant to Section 8.2.2, then
such sublicense and this Agreement shall survive in such case with the
Sublicensee being substituted in the place of Quark in this Agreement, provided
that such Sublicensee (i) is not, on the effective date of such would-be
termination, in breach of any provisions of its sublicense agreement with Quark
that materially affect Licensor; (ii) agrees, in a subsequent writing, to
perform and deliver directly to Licensor all obligations and payments that would
be due to Licensor under this Agreement with respect to matters within the scope
of such sublicense; and (iii) agrees, in a subsequent writing, that,
regardless of Quark’s rights and obligations to such Sublicensee under such
sublicense, Licensor’s rights and obligations to such Sublicensee shall be no
different than Licensor’s rights and obligations to Quark under this
Agreement.
8.2.3 Termination for Lack of
Licensed Patent(s). Quark may terminate this Agreement upon
[*] notice if a Licensed Patent is not issued within four (4) years after the
Effective Date.
8.2.4 Termination for
Discontinuation of p53 Clinical Program. In the event that
Quark discontinues its clinical program for the p53 Sequence, it may terminate
this Agreement upon [*] notice, provided, however, that no refunds or credits of
any kind shall be due or payable in the event of such a
termination.
8.3 Effect of Termination or
Expiration.
8.3.1 Upon
termination of this Agreement by Licensor pursuant to Section 8.2.1 for
material breach of this Agreement (but excluding a material breach by Quark of
its diligence obligations under Section 2.2 which is
handled under Section
8.3.2), all rights and licenses granted to Quark under Article 3 shall
immediately terminate on a Licensed Product-by-Licensed Product basis.
Notwithstanding the foregoing, if Quark has granted any sublicense that is in
effect at the time that this Agreement would otherwise be terminated by Licensor
pursuant to Section
8.2.1, then such sublicense and this Agreement shall survive in such case
with the Sublicensee being substituted in the place of Quark in this Agreement,
provided that such Sublicensee (i) is not, on the effective date of such
would-be termination, in breach of any provisions of its sublicense agreement
with Quark that materially affect Licensor; (ii) agrees, in a subsequent
writing, to perform and deliver directly to Licensor all obligations and
payments that would be due to Licensor under this Agreement with respect to
matters within the scope of such sublicense; and (iii) agrees, in a
subsequent writing, that, regardless of Quark’s rights and obligations to such
Sublicensee under such sublicense, Licensor’s rights and obligations to such
Sublicensee shall be no different than Licensor’s rights and obligations to
Quark under this Agreement.
8.3.2 In the
event Licensor seeks to terminate this Agreement pursuant to Section 8.2.1 for
material breach by Quark of its diligence obligations under Section 2.2, the
Parties shall follow the procedures described in Section 8.2.1 as
modified by this Section 8.3.2 with
respect to the time period in which Quark may cure the breach if indeed the
arbitrator finally determines that Quark has breached its diligence
obligations. After submitting the dispute for dispute resolution
under Article
12, if the arbitrator finally determines that Quark has breached its
diligence obligations under Section 2.2, Quark
shall have a period of time as specified by the arbitrator following the
conclusion of such dispute resolution procedure to implement the arbitrator’s
cure for such failure. If Quark fails to implement the arbitrator’s
cure for the diligence failure within such period, then Licensor shall have the
right to terminate this Agreement immediately on a Licensed Product-by-Licensed
Product basis. During the dispute resolution procedure, this
Agreement shall continue in full force and effect.
[ * ] = 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.
14
8.3.3 Upon
termination of this Agreement by Quark pursuant to Sections 8.2.3 or
8.2.4, all rights and licenses granted to Quark (including all
sublicenses granted by Quark hereunder) under Article 3 shall
immediately terminate.
8.3.4 Termination
or expiration of this Agreement, through any means and for any reason, shall not
relieve the Parties of any obligation accruing prior thereto, including the
payment of all sums due and payable, and shall be without prejudice to the
rights and remedies of either Party with respect to any antecedent breach of any
of the provisions of this Agreement.
8.4 Survival. In
addition to as set forth in Section 8.3 and
otherwise explicitly set forth in this Agreement, Articles 1, 10, 11, 12 and
13 and Sections
8.3, 8.4 and 9.3, and, as applicable, Article 5 shall
survive expiration or termination of this Agreement for any reason.
ARTICLE
9: REPRESENTATIONS AND WARRANTIES
9.1 Licensor
Representations. Licensor hereby represents and warrants to
Quark that:
9.1.1
As of the Effective Date, Licensor represents that:
(a) Licensor
has the full right, power and authority, and has obtained all approvals, permits
or consents necessary, to enter into this Agreement and to perform all of its
obligations and to grant the licenses provided hereunder.
(b) As
of the Effective Date, to Licensor’s knowledge, no loss or expiration of any of
the p53 Patent Application is threatened, pending, or reasonably foreseeable,
except for patents expiring at the end of their statutory terms (and not as a
result of any act or omission by Licensor, including a failure to pay any
required maintenance fees).
(c) As
of the Effective Date, the p53 Patent Application is the only patent or patent
application Controlled by Licensor that specifically claims or Covers the p53
Sequence.
9.1.2
Licensor hereby represents and warrants to Quark that as of the Effective
Date and through out the Term:
(a) Licensor
is the sole and exclusive owner of the p53 Patent Application, free and clear of
any liens or encumbrances. For clarity, Quark acknowledges that it
may be required to obtain diagnostic, therapeutic or other licenses from Third
Parties to commercialize a Licensed Product.
(b) Licensor
has not, prior to the Effective Date, entered into and shall not, following the
Effective Date, enter into any agreement that conflicts or interferes with
Quark’s exclusive license to Licensed Product(s) under the Licensed Patent(s) in
the Exclusive Field.
(c) Licensor
follows reasonable commercial practices common in the industry to protect its
proprietary and confidential information, including requiring its employees,
consultants and agents to be bound in writing by obligations of confidentiality
and non-disclosure, and requiring its employees, consultants and agents to
disclose and assign to it any and all inventions and discoveries discovered by
such employees, consultants and/or agents made within the scope of, and during
their employment, and only disclosing proprietary and confidential information
to Third Parties pursuant to written confidentiality and non-disclosure
agreements.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS AMENDED.
15
9.2 Quark
Representations. Quark hereby represents and warrants the
following to Licensor:
9.2.1 Quark
has the full right, power and authority, and have obtained all approvals,
permits or consents necessary, to enter into this Agreement and to perform all
of its obligations hereunder.
9.2.2 Quark
has not, prior to the Effective Date, entered into and shall not, following the
Effective Date, enter into any agreement that conflicts in any way with this
Agreement or Quark’s obligations hereunder.
9.2.3 Quark
follows reasonable commercial practices common in the industry to protect its
proprietary and confidential information, including requiring its employees,
consultants and agents to be bound in writing by obligations of confidentiality
and non-disclosure, and requiring its employees, consultants and agents to
disclose and assign to it any and all inventions and discoveries
discovered by such employees, consultants and/or agents made within the scope
of, and during their employment, and only disclosing proprietary and
confidential information to Third Parties pursuant to written confidentiality
and non-disclosure agreements.
9.3 DISCLAIMER. THE
WARRANTIES SET FORTH IN SECTIONS 9.1 AND
9.2 ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, VALIDITY, NON-INFRINGEMENT AND ALL SUCH OTHER
WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED.
ARTICLE
10: INDEMNIFICATION
10.1 Indemnification by
Licensor. Licensor shall defend, indemnify and hold harmless
Quark and its Affiliates and Sublicensees and their respective officers,
directors, employees and agents from and against any and all Third Party
liabilities, claims, suits, and expenses, including reasonable attorneys’ fees
(collectively, “Losses”), to the
extent arising out of or attributable to (i) the inaccuracy or breach of any
representation or warranty made by Licensor under this Agreement, or (ii) the
negligence or willful misconduct of Licensor or its Affiliates or their
respective officers, directors or employees; in each case except to the extent
that such Losses are subject to indemnification pursuant to Section
10.2. For clarity, Licensor shall have no obligation under
this Section 10.1 with respect to Losses that result from Quark’s negligence or
willful misconduct.
10.2 Indemnification by
Quark. Quark shall defend, indemnify and hold harmless
Licensor its Affiliates and their respective officers, directors, employees and
agents from and against any and all Losses, to the extent arising out of or
attributable to (i) the inaccuracy or breach of any representation or warranty
made by Quark under this Agreement, (ii) product liability for bodily injury
and/or property damage resulting from or related to the Licensed Products or
(iii) the development, marketing, approval, manufacture, packaging, labeling,
handling, storage, transportation, use, distribution, promotion, marketing or
sale of Licensed Products by Quark, its Affiliates or its Sublicensees or (iv)
the negligence or willful misconduct of Quark, its Affiliates or Sublicensees,
or their respective officers, directors or employees; in each case except to the
extent that such Losses are subject to indemnification pursuant to Section
10.1. For clarity, Quark shall have no obligation under this
Section 10.2 with respect to Losses that result from Licensor’s negligence or
willful misconduct. Quark shall include an indemnification provision
in any sublicense agreement that requires Sublicensee to indemnify Licensor for
Losses arising out of or attributable to such Sublicensee’s actions consistent
with this Section
10.2.
[ * ] = 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.
16
10.3 Indemnification
Procedures. If a Party intends to claim indemnification under
this Article 10
(“Indemnified
Party”), it shall promptly notify the other Party (the “Indemnifying Party”)
in writing of such alleged Losses. The Indemnifying Party shall have
the right to control the defense thereof with counsel of its choice as long as
such counsel is reasonably acceptable to the Indemnified Party; provided, that
any Indemnified Party shall have the right to retain its own counsel at its own
expense for any reason. The Indemnified Party, its employees and
agents, shall reasonably cooperate with the Indemnifying Party and its legal
representatives in the investigation or defense of any Losses covered by this
Article
10. The failure to deliver written notice to the Indemnifying
Party within a reasonable time after the commencement of any such action, to the
extent prejudicial to its ability to defend such action, shall relieve the
Indemnifying Party of any obligation to the Indemnified Party under this Section 10.3. It
is understood that only Licensor or Quark may claim indemnity
under this Article
10 (on its own behalf or on behalf of its Indemnified Parties), and other
Indemnified Parties may not directly claim indemnity hereunder.
10.4 Insurance.
10.4.1 Coverage. Each
Party shall maintain, at its own cost, the insurance coverages set forth in this
Section 10.4;
provided, however, that Licensor has the right, in its sole discretion, to
self-insure in part or in whole for any such coverage through its parent Thermo
Xxxxxx Scientific.
(a) Commencing
as of the Effective Date, and thereafter for the period of time required under
Section 10.4.1,
each Party shall obtain and maintain on an ongoing basis, Commercial General
Liability insurance, including contractual liability, in the minimum amount of
[*], combined single limit for bodily injury and property damage
liability.
(b) Commencing
as of the date Quark files an IND for a product, and thereafter for the period
of time required under Section 10.4.1,
Quark shall obtain and maintain on an ongoing basis, Products Liability
insurance, including contractual liability, in the minimum amount of [*],
combined single limit for bodily injury and property damage
liability.
10.4.2 Additional
Requirements. Except to the extent that Licensor self-insures
as authorized under Section 10.4.1,
the following provisions apply:
(a) All
insurance coverages shall be primary insurance with respect to each Party’s own
participation under this Agreement, and shall be maintained with an insurance
company or companies having an A.M. Best’s rating (or its equivalent) of
A-XII or better.
(b) If
a Party’s insurance coverage is provided on a Claims Made or Claims Made and
Reported basis, such insurance shall have a retroactive date that precedes
the date of this agreement. Such insurance shall continue throughout the term of
the Agreement; and upon the termination of this Agreement such insurance shall
(i) be maintained with a retroactive date that precedes the date of this
Agreement for a minimum period of [*] or (ii) may be replaced with other Claims
Made or Claims Made and Reported coverage that has a retroactive date that
precedes the date of this Agreement which will remain in effect for a minimum
period of [*] or (iii) may be cancelled after the termination of this Agreement
but only if the Party purchases or arranges for the purchase of an Extended
Reporting Endorsement for a period of [*] in duration.
(c) Each
Party shall provide to the other Party its respective certificates of insurance
evidencing the insurance coverages set forth in Section 10.4.1. Each
Party shall provide to the other Party reasonable written notice of any
cancellation, nonrenewal or material change in any of the insurance
coverages. Each Party shall, upon receipt of written request from the
other Party, provide renewal certificates to the other Party for as long as such
Party is required to maintain insurance coverages hereunder.
10.5 LIMITATION ON
DAMAGES. NOTWITHSTANDING ANYTHING CONTAINED IN THIS AGREEMENT
TO THE CONTRARY, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY
HEREUNDER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR INDIRECT
DAMAGES (INCLUDING LOSS OF PROFITS OR COSTS OF COVER) WHETHER BASED UPON BREACH
OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, STRICT TORT OR ANY OTHER LEGAL
THEORY. THE FOREGOING LIMITATIONS WILL NOT LIMIT EITHER PARTY’S
LIABILITY TO THE OTHER PARTY UNDER ARTICLES 10 (INDEMNIFICATION) AND 11
(CONFIDENTIALITY) OF 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.
17
ARTICLE
11: CONFIDENTIALITY
11.1 Confidential
Information. During the Term of this Agreement and for [*]
thereafter without regard to the means of termination: (i) Licensor
shall not use, for any purpose other than the purpose of this Agreement, or
reveal or disclose to any Third Party Quark Confidential Information; and (ii)
Quark shall not use, for any purpose other than the purpose of this Agreement,
or reveal or disclose to any Third Party Licensor Confidential
Information. The Parties shall take reasonable measures to assure
that no unauthorized use or disclosure is made by others to whom access to such
information is granted.
11.2 Exceptions. Notwithstanding
the foregoing, a Party may use and disclose Confidential Information (including
any Quark Confidential Information or Licensor Confidential Information) as
follows:
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(a)
|
if
required by applicable law, rule, regulation, government requirement
and/or court order; provided, that, the disclosing Party promptly notifies
the other Party of its notice of any such requirement and provides the
other Party a reasonable opportunity to seek a protective order or other
appropriate remedy and/or to waive compliance with the provisions of this
Agreement;
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(b)
|
to
the extent such use and disclosure occurs in the filing or publication of
any patent application or patent on
inventions;
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|
(c)
|
as
necessary or desirable for securing any regulatory approvals, including
pricing approvals, for any Licensed Products; provided, that, the
disclosing Party shall take all reasonable steps to limit disclosure of
the Confidential Information outside such regulatory agency and to
otherwise maintain the confidentiality of the Confidential
Information;
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(d)
|
to
take any lawful action that it deems necessary to protect its interest
under, or to enforce compliance with the terms and conditions of, this
Agreement; and
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(e)
|
to
the extent necessary, to its Affiliates, directors, officers, employees,
consultants, or Sublicensees (as applicable and including potential
Sublicensees), actual or potential acquirors, vendors and clinicians under
written agreements of confidentiality at least as restrictive as those set
forth in this Agreement, who have a need to know such information in
connection with such Party performing its obligations or exercising its
rights under this Agreement.
|
11.3 Certain
Obligations. During the term of this Agreement and for a
period of [*] thereafter and subject to the exceptions set forth in Section 11.2, Quark,
with respect to Licensor Confidential Information, and Licensor, with respect to
Quark Confidential Information, agree:
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(a)
|
to
use such Confidential Information only for the purposes contemplated under
this Agreement,
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|
(b)
|
to
treat such Confidential Information as it would its own proprietary
information which in no event shall be less than a reasonable standard of
care,
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|
(c)
|
to
take reasonable precautions to prevent the disclosure of such Confidential
Information to a Third Party without written consent of the other Party,
and
|
[ * ] = 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.
18
|
(d)
|
to
only disclose such Confidential Information to those employees, agents and
Third Party contractors who have a need to know such Confidential
Information for the purposes set forth herein and who are subject to
obligations of confidentiality no less restrictive than those set forth
herein.
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11.4 Disclosures and Public
Announcements. Neither Party shall issue any press release or
other publicity materials, or make any public presentation with respect to any
of the terms or conditions of, this Agreement or
the programs or efforts being conducted by the other Party hereunder, in each case without
the prior written consent of the other Party. This restriction shall
not apply to:
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(a)
|
the
joint press release which the Parties may issue following the Effective
Date in a form to be mutually agreed. The Parties agree to
coordinate the preparation of such press release so as to give each Party
sufficient time to review and comment
thereon;
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(b)
|
disclosures
to a Party’s attorneys, advisors, or actual or potential investors,
Sublicensees, and acquirors, on a need to know basis under circumstances
that reasonably ensure the confidentiality thereof;
and
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(c)
|
any
future disclosures required by law or regulation, including as may be
required in connection with any filings made with, or by the disclosure
policies of a major stock exchange; provided that the disclosing Party (i)
use all reasonable efforts to inform the other Party prior to making any
such disclosures and cooperate with the other Party in seeking a
protective order or other appropriate remedy (including redaction) and
(ii) whenever possible, request confidential treatment of such
information.
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11.5 Scientific
Publications. If Quark, including its employees, agents or
consultants, wishes to make a scientific or technical publication, presentation
and/or other related oral disclosure related to the p53 Patent Application that
includes Licensor Confidential Information (but excluding clinical studies or
other development, commercial or marketing publications related to Licensed
Products), Quark shall deliver to Licensor a copy of the proposed written
publication or an outline of the proposed presentation or oral disclosure at
least [*] prior to submission for publication, presentation and/or other oral
disclosure. Licensor may then (a) request (within [*] of the
delivery of the publication or outline) modifications to the publication or
outline for patent reasons, and Quark shall make such modifications,
(b) delete (within [*] of the delivery of the publication or outline) any
trade secrets or Confidential Information of Licensor (but excluding any
information that relates directly to the sequence, structure or activity of a
Licensed Product that is the subject of the proposed publication, presentation
or related oral disclosure) included in that publication or outline, and/or
(c) request (within [*] of the delivery of the publication or outline) a
reasonable delay of no more than [*] from the date such delay is requested by
Licensor in publication, presentation and/or other oral disclosure to protect
know-how and patentable subject matter. In the event that Quark does
not receive any response from Licensor with respect to Quark’s proposed written
publication or outline of the proposed presentation or oral disclosure within
[*] of the delivery of the publication or outline, subject to the terms of this
Agreement, Quark shall be free to publish, present or otherwise orally disclose
the information contained in such publication or outline.
11.6 Termination
Event. Upon termination, but not expiration, of this Agreement
and upon the request of the disclosing Party, the receiving Party shall promptly
return to the disclosing Party or destroy all copies of Confidential Information
received from such Party, and shall return or destroy, and document the
destruction of, all summaries, abstracts, extracts, or other documents which
contain any Confidential Information of the other Party in any form, except that
each Party shall be permitted to retain a copy (or copies, as necessary) of such
Confidential Information (a) for archival purposes, (b) as required by any law
or regulation, (c) contained in laboratory notebooks retained in accordance with
a Party’s Standard Operating Procedures, and (d) in the case of Quark, for
purposes of exploiting its surviving rights pursuant to Section
13.13.
[ * ] = 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.
19
ARTICLE
12: ARBITRATION
12.1 Disputes. This
Agreement is made on the basis of mutual confidence, and it is understood that
the differences, if any, during the life of this Agreement should freely be
discussed between the two Parties. The Parties shall initially
attempt in good faith to resolve any significant controversy, claim, or dispute
arising out of or relating to this Agreement, or its interpretation,
performance, nonperformance or any breach of any respective obligations
hereunder (hereinafter collectively referred to as a “Dispute”) through
negotiations between senior executives of Licensor and Quark (or their
respective designee). If the Dispute is not resolved within [*] (or
such other period of time mutually agreed upon by the Parties) of commencing
such face-to-face negotiations, or if the Party against which a claim has been
asserted refuses to attend such negotiations or does not otherwise participate
in such negotiations within [*] (or such other period of time mutually agreed
upon by the Parties) from the date of notice of a Dispute, either Party may, by
written notice to the other, invoke the provisions of Section
12.2.
12.2 Arbitration. Subject
to Sections 12.1 and
12.3, the Parties agree to resolve any Dispute exclusively through
binding arbitration conducted under the auspices of the American Arbitration
Association (the “AAA”) pursuant to
AAA’s Commercial Arbitration Rules then in effect (the “AAA
Rules”). The arbitration shall be conducted in the English
language before one (1) arbitrator appointed in accordance with the AAA Rules;
provided that such arbitrator shall have had, by the time of the actual
arbitration, at least ten (10) years of experience as an attorney and experience
in the pharmaceuticals industry so as to better understand the legal, business
and scientific issues addressed in the arbitration. Unless agreed
otherwise by the Parties, the Parties shall have [*] from the appointment of the
arbitrator to present and/or submit their positions to the arbitrator, and the
Parties shall have a hearing before the arbitrator within [*] of such
submission. The arbitrator shall hear evidence by each Party and
resolve each of the issues identified by the Parties. The arbitrator
shall be instructed and required to render a written, binding, non-appealable
resolution and award on each issue which clearly states the basis upon which
such resolution and award is made. The written resolution and award
shall be delivered to the Parties as expeditiously as possible, but in no event
more than [*] after conclusion of the hearing, unless otherwise agreed to by the
Parties. The Parties shall use all reasonable efforts to keep
arbitration costs to a minimum. Each Party must bear its own
attorneys’ fees and associated costs and expenses, as well as an equal share of
the fees and costs incurred by AAA and the arbitrator. The Parties
shall use all reasonable efforts to make witnesses available for the
proceedings. Unless otherwise mutually agreed by the Parties, the
arbitration proceedings shall be conducted in San Francisco.
12.3 Subject Matter
Exclusions. Notwithstanding the foregoing, the provisions of
Sections 12.1 and
12.2 shall not apply to any Dispute relating to: (i) any
antitrust, anti-monopoly or competition law or regulation, whether or not
statutory; or (ii) the determination of validity of claims or claim
interpretation relating to a Party’s patents, trademarks or
copyright. Notwithstanding anything to the contrary in the foregoing
provision of this Section 12.3, any
Dispute relating to Quark and/or its Affiliate(s)’s or Sublicensee’s assertion
of non-infringement of or by any of its activities with respect to Licensed
Patent(s), including without limitation any assertion by Quark or its Affiliates
that the making, using, selling, offering for sale and importation of any
Licensed Product(s) do not infringe Licensed Patent(s) (“Patent Infringement
Dispute”) shall be subject to the provisions of Sections 12.1 and
12.2, provided that the arbitrator provided in Section 12.2 shall
have had, by the time of the actual arbitration, at least ten (10) years of
experience as a practicing patent attorney registered to practice before the
United States Patent and Trademark Office so as to better understand the
patent-related issues addressed in the Patent Infringement Dispute.
12.4 Equitable
Relief. Nothing in this Agreement shall be deemed as
preventing the Parties from seeking injunctive relief (or other provisional
remedy) from any court having jurisdiction over the Parties and the subject
matter of the dispute as necessary to protect either Party’s
interests.
[ * ] = 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.
20
ARTICLE
13: MISCELLANEOUS
13.1 Assignment and
Delegation. This Agreement shall be personal to Quark and
shall not be assigned by Quark in whole or in part except: (a) with prior
written consent of Licensor, which shall not be unreasonably withheld; or (b) as
part of a sale or transfer of substantially the entire business of Quark
relating to operations that concern this Agreement whether by sale, merger,
operation of law or otherwise. Quark shall notify Licensor within [*]
of any proposed assignment of this Agreement. Any permitted
assignee shall assume all obligations of Quark under this
Agreement. Notwithstanding the foregoing, Licensor may assign or
transfer its rights and obligations under this Agreement to a Person that
succeeds to all or substantially all of Licensor’s business or assets whether by
sale, merger, operation of law or otherwise. This Agreement shall be
binding upon and inure to the benefit of and be enforceable by the Parties
hereto and their respective successors and permitted assignees. Any
transfer or assignment of this Agreement in violation of this Section 13.1 shall be
null and void.
13.2 Change of
Control. No later than [*] following the public announcement
of a proposed Change of Control event, the Party experiencing such Change of
Control shall provide the other Party with written notice of any such Change of
Control. “Change of Control”
event shall mean any transaction in which a Party: (a) sells, conveys or
otherwise disposes of all or substantially all of its property or business; or
(b) (i) merges, consolidates with, acquires or is acquired by any other person
(other than an Affiliate of such Party) or (ii) effects any other transaction or
series of transactions such that the stockholders of such Party immediately
prior thereto, in the aggregate, no longer own, directly or indirectly,
beneficially or legally, at least fifty percent (50%) of the outstanding voting
securities or capital stock of the surviving person following the closing of
such merger, consolidation, other transaction or series of transactions.
Notwithstanding the foregoing, a Change of Control shall not be deemed to occur
on account of a public offering of a Party’s equity securities, or the
acquisition of securities of a Party by one or more institutional investors, or
Affiliate thereof, who acquire a Party’s securities in a transaction or series
of related transactions as a passive investment which does not directly affect
the management of such Party (which effect shall not be deemed to have occurred
in the event of a change of any single member of management, including the Chief
Executive Officer), or a merger or other transaction effected exclusively for
the purpose of changing the corporate domicile of a Party.
13.3 Entire
Agreement. This Agreement contains the entire agreement
between the Parties relating to the subject matter hereof, and all prior
understandings, representations and warranties between the Parties are
superseded by this Agreement, including the Non- Disclosure Agreement between
the Parties dated [*].
13.4 Amendments. Changes
and additional provisions to this Agreement shall be binding on the Parties only
if mutually agreed upon, laid down in writing and signed effectively by the
Parties.
13.5 Applicable
Law. This Agreement shall be construed and interpreted in
accordance with the laws of New York and all rights and remedies shall be
governed by such laws without regard to principles of conflicts of
law.
13.6 Force
Majeure. If the performance of this Agreement or any
obligations hereunder is prevented, restricted or interfered with by reason of
earthquake, fire, flood or other casualty or due to strikes, riot, storms,
explosions, acts of God, war, or a similar occurrence or condition beyond the
reasonable control of the Parties, the Party so affected shall, upon giving
prompt notice to the other Parties, be excused from such performance during such
prevention, restriction or interference, and any failure or delay resulting
therefrom shall not be considered a breach of this Agreement.
13.7 Severability. The
Parties do not intend to violate any public policy or statutory common
law. However, if any sentence, paragraph, clause or combination of
this Agreement is in violation of any law or is found to be otherwise
unenforceable, such sentence, paragraph, clause or combination of the same shall
be deleted and the remainder of this Agreement shall remain binding; provided
that such deletion does not alter the basic purpose and structure of 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.
21
13.8 Notices. All
notices, requests, demands, and other communications relating to this Agreement
shall be in writing in the English language and shall be delivered in person or
by registered mail, international courier or facsimile transmission (with a
confirmation copy forwarded by courier or registered mail). Notices
sent by mail shall be sent by first class mail or the equivalent, registered or
certified, postage prepaid, and shall be deemed to have been given on the date
actually received. Notices sent by international courier shall be
sent using a service which provides traceability of packages. Notices
shall be sent as follows:
Notices
to Quark:
Chief
Executive Officer
Quark
Pharmaceuticals, Inc.
0000
Xxxxxxxxx Xxxxxx
Xxxxxxx,
XX 00000
Telephone:
000-000-0000
Facsimile:
000-000-0000
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with a
required copy to:
[*]
Quark
Pharmaceuticals, Inc.
0000
Xxxxxxxxx Xxxxxx
Xxxxxxx,
XX 00000
Telephone:
000-000-0000
Facsimile:
000-000-0000
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Notices
to Licensor:
General
Manager
Dharmacon,
Inc.
0000
Xxxxxxxx Xx., Xxxxx 000
Xxxxxxxxx,
XX 00000
Telephone:
Facsimile:
|
with a
required copy to:
General
Counsel, Biosciences Division
Thermo
Xxxxxx Scientific
0000
Xxxxxxxx Xx., Xxxxx 000
Xxxxxxxxx,
XX 00000
Telephone:
[*]
Facsimile:
000-000-0000
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Either
Party may change its address for notices or facsimile number at any time by
sending written notice by courier or registered mail to the other
Party.
13.9 Independent
Contractor. Nothing herein shall create any association,
partnership, joint venture, fiduciary duty or the relation of principal and
agent between the Parties hereto, it being understood that each Party is acting
as an independent contractor, and neither Party shall have the authority to bind
the other or the other’s representatives in any way.
13.10 Waiver. No
delay on the part of either Party hereto in exercising any power or right
hereunder shall operate as a waiver thereof, nor shall any single or partial
exercise of any power or right hereunder preclude other or further exercise
thereof or the exercise of any other power or right. No waiver of
this Agreement or any provision hereof shall be enforceable against any Party
hereto unless in writing, signed by the Party against whom such waiver is
claimed, and shall be limited solely to the one event.
13.11 Interpretation. This
Agreement has been prepared jointly and no rule of strict construction shall be
applied against either Party. In this Agreement, the singular shall
include the plural and vice versa and the word “including” shall be deemed to be
followed by the phrase “without limitation.”
13.12 Counterparts. This
Agreement may be executed in counterparts, each of which together shall
constitute one and the same Agreement. For purposes of executing this
agreement, a facsimile copy of this Agreement, or .pdf copy, including the
signature pages, will be deemed an original.
[ * ] = 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.
22
13.13 License Survival During
Bankruptcy. All rights and licenses granted under or pursuant
to this Agreement are, and shall otherwise be deemed to be, for purposes of
Paragraph 365(n) of the U.S. Bankruptcy Code, licenses of rights to
“intellectual property” as defined under Paragraph 101(35A) of the U.S.
Bankruptcy Code. The Parties agree that Quark, as a licensee of such
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code. The Parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against Licensor, including under the U.S. Bankruptcy Code, Quark shall 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 Quark’s possession, shall be promptly delivered
to Quark upon any such commencement of a bankruptcy proceeding upon written
request therefor by Quark.
IN
WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representative.
Dharmacon,
Inc.
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Quark
Pharmaceuticals, Inc.
|
|||
By:
|
/s/
Xxxxxxxx Xxxxxxx
|
By:
|
/s/
D. Zurr
|
|
Name:
|
Xxxxxxxx
Xxxxxxx
|
Name:
|
Xxxxxx
Xxxx, Ph.D.
|
|
Title:
|
VP
and General Manager
|
Title:
|
President
& CEO
|
[ * ] = 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.
23