COLLABORATION AND LICENSE AGREEMENT by and between ROSETTA GENOMICS, LTD. and US GENOMICS, INC. May 12, 2006
by
and between
ROSETTA
GENOMICS, LTD.
and
US
GENOMICS, INC.
May
12, 2006
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
This
COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of May
12, 2006, by and between Rosetta Genomics, Ltd., a corporation organized under
the country of Israel having an address of 00 Xxxxx Xxxxxx, Xxxxxxx Xxxx,
Xxxxxxx, Xxxxxx (“Rosetta Genomics”) and US Genomics, Inc., a Delaware
corporation having an address of 00 Xxxx Xxxxxx. Xxxxx 0000, Xxxxxx, XX 00000
(“US Genomics”). Each of US Genomics and Rosetta Genomics is sometimes referred
to individually herein as a “Party” and collectively as the
“Parties.”
WHEREAS,
Rosetta Genomics is in the business of developing confidential and proprietary
technology relating to the detection of biomarkers based on xxXXX for Diagnosis
of various diseases, including without any limitation Lung Cancer;
and
WHEREAS,
US Genomics is in the business of developing and commercializing instruments
and
related reagents for the detection of molecules, including the development
of
the US Genomics Platform; and
WHEREAS,
Rosetta Genomics and US Genomics desire to enter into a collaboration for the
purpose of jointly developing the Products and the Services; and
WHEREAS,
Rosetta Genomics wishes to acquire, and US Genomics has agreed to supply to
Rosetta Genomics, the US Genomics Platform and reagent kits for use thereon
for
the purpose of researching, developing and commercializing the Products and
the
Services; and
WHEREAS,
US Genomics has agreed to non-exclusively license Rosetta Genomics under the
US
Genomics Know How and the US Genomics Patent Rights the right to develop and
commercialize the Products and the Services on the terms set forth
herein;
NOW,
THEREFORE, in consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the Parties hereto, intending to be
legally bound, hereby agree as follows:
ARTICLE
I
DEFINITIONS
Unless
specifically set forth to the contrary herein, the following terms, whether
used
in the singular or plural, shall have the respective meanings set forth
below:
1.1. |
“Affiliate”
of a Party or other entity shall mean any entity that, directly or
indirectly, is controlled by, controls, or is under common control
with
such Party including (i) any corporation or business entity of which
at
least fifty percent (50%) of the securities or other ownership interests
representing the equity or right to receive profits, the voting stock,
general partnership interest or power to direct the affairs of such
entity, are owned, controlled or held, directly or indirectly, by
a Party
or such entity; (ii) any corporation or business entity which, directly
or
indirectly, owns, controls or holds at least fifty percent (50%)
of the
securities or other ownership interests representing the equity or
right
to receive profits, voting stock, general partnership interest or
power to
direct the affairs of, a Party or such entity; or (iii) any corporation
or
business entity of which a Party or such entity has the right to
acquire,
directly or indirectly, at least fifty percent (50%) of the securities
or
other ownership interests representing the equity or right to receive
profits, voting stock, general partnership interest or power to direct
the
affairs, thereof.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.2. |
“Business
Day”
shall mean any day that is not a Saturday or a Sunday or a day on
which
the New York Stock Exchange or the Tel Aviv Stock Exchange is
closed.
|
1.3. |
“Calendar
Quarter”
shall mean the respective periods of three (3) consecutive calendar
months
ending on March 31, June 30, September 30 and December
31.
|
1.4. |
“Calendar
Year”
shall mean each successive period of twelve (12) months commencing
on
January 1 and ending on December
31.
|
1.5. |
“Customers”
shall mean patients, hospitals, physicians, medical institutions,
health
funds, pharmacies and other retailers, provided that they are not
an
Affiliate of Rosetta Genomics and other purchasers of the Products
other
than for resale.
|
1.6. |
“Development
Plan”
shall mean the plan to develop the Products and Services attached
hereto
as Exhibit A.
|
1.7. |
“Early
Detection”
means the determination of the presence of a disease prior to the
appearance of symptoms.
|
1.8. |
“Effective
Date”
shall mean the date first above
written.
|
1.9. |
“FDA”
shall mean the United States Food and Drug Administration and any
successor agency having substantially the same functions and any
corresponding or successor regulatory authority in any other jurisdiction
if the context so indicates.
|
1.10. |
“Field”
shall mean Early Detection of Lung Cancer based on detection of microRNA
markers of Lung Cancer tumors in sputum and/or
blood.
|
1.11. |
“First
Commercial Sale”
shall mean the first for-profit sale of a Product or a Service by
Rosetta
Genomics or its Affiliates in any country in the Territory, for end
use or
consumption (including sales to a distributor or similar agent);
provided,
that, any sale to an Affiliate or Sublicensee will not constitute
a First
Commercial Sale unless the Affiliate or Sublicensee is the last entity
in
the distribution chain of the Product or
Service.
|
1.12. |
“GAAP”
means generally accepted accounting principles in the United
States.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.13. |
“Improvement”
shall mean any and all improvements and enhancements, patentable
or
otherwise, related to the Product, Services, US Genomics Platform
or US
Genomics proprietary reagents including, without limitation, in the
manufacture, formulation, ingredients, preparation, presentation,
means of
delivery or administration, indication, use or packaging of the Product,
Services, US Genomics Platform or US Genomics proprietary
reagents.
|
1.14. |
“Information
and Inventions”
shall mean all discoveries, Improvements, processes, formulas, data,
inventions, know-how and trade secrets, patentable or otherwise arising
from the activities of the Parties under this
Agreement.
|
1.15. |
“LIBOR”
shall mean, with respect to any interest period, the rate per annum,
reported by XX Xxxxxx Xxxxx or any successor thereto, at which deposits
in
United States dollars are offered to prime commercial banks in the
London
interbank market at approximately 11:00 a.m., New York City time
on the
Business Day immediately preceding the commencement of such interest
period.
|
1.16. |
“Lung
Cancer”
shall mean the development of malignant neoplasia of the lung and
associated disregulation of genes within the lung
tissue.
|
1.17. |
“Net
Sales”
shall mean the aggregate gross amount invoiced with respect to Services
or
Products by Rosetta Genomics or its Affiliates or its Sublicensees
to
Customers, after deducting (if not previously deducted from the amount
invoiced):
|
(i) |
quantity
and/or cash discounts directly related to the sale of the
Product;
|
(ii) |
customs
duties, VAT or any other sales taxes or levies to the extent applicable
to
the sale or export of Products or Services and not collected separately
from the counterparty to the sale;
|
(iii) |
recalls,
credits and allowances on account of returned or rejected products,
including, but not limited to, allowance for breakage or
spoilage;
|
(iv) |
payments
paid in connection with transporting, packaging and insuring the
Products
and appearing separately on invoices;
and
|
(v) |
amounts
not actually collected.
|
Notwithstanding
the foregoing, sales or other transfers between Rosetta Genomics and its
Affiliates shall be excluded from the computation of Net Sales and no royalty
payments shall be payable on such sales or transfers except where such
Affiliates are end users, but Net Sales shall include the subsequent sales
to
Customers by such Affiliates. Sales to wholesalers or distributors shall be
included in Net Sales and sales by a wholesaler or distributor shall not be
included in Net Sales.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.18. |
“Other
US Genomics Patented Product”
shall mean any product or service sold for use in the Field whose
composition of matter or use in the Field is covered by one or more
Valid
Claims, where the Early Detection is made using a system other than
the US
Genomics Platform.
|
1.19. |
“Product”
shall mean a US Genomics Based Product or an Other US Genomics Patented
Product. For purposes of clarity, (x) Products shall not include
(a) the
US Genomics Platform or any modification or improvement thereof or
(b) any
“next generation” US Genomics Platform and (y) all Products shall be
listed in Schedule 1.18 attached hereto, as updated from time to
time by
Rosetta Genomics and US Genomics during the
Term.
|
1.20. |
“Proprietary
Information”
shall mean any and all scientific, clinical, regulatory, marketing,
financial and commercial information or data, whether communicated
in
writing, orally or by any other means, which is provided by one Party
to
the other Party in connection with this Agreement. For clarity, any
microRNA sequence disclosed by Rosetta Genomics to US Genomics shall
be
Proprietary Information of Rosetta Genomics, to the extent the foregoing
do not fall within the exceptions described in clauses (i) through
(iv) of
Section 4.1.
|
1.21. |
“Proprietary
Materials”
shall mean any tangible chemical, biological or physical research
materials that are furnished by or on behalf of the Transferring
Party to
the Recipient Party in connection with this Agreement, regardless
of
whether such materials are specifically designated as proprietary
by the
Transferring Party.
|
1.22. |
“Regulatory
Requirements”
shall mean current applicable manufacturing and other requirements
for
Products as defined in regulations promulgated by the FDA and, for
Products intended for shipment to any country other than the United
States, as defined in regulations promulgated by the corresponding
regulatory authority in such
country.
|
1.23. |
“Rosetta
Genomics Know-How”
shall mean Rosetta Genomics Information and Inventions, and any and
all
other information and materials, including but not limited to,
discoveries, information, improvements, processes, formulas, data,
inventions, know-how and trade secrets, patentable or otherwise,
which in
all cases
|
(i) |
relate
to the Products or the Services;
and
|
(ii) |
are
in Rosetta Genomics’ possession or control as of and after the date hereof
and as to which Rosetta Genomics has the right to license or sublicense
to
third parties, and are necessary or useful to Rosetta Genomics in
connection with the rights granted and activities contemplated under
this
Agreement.
|
Such
know-how shall include, without limitation, all chemical, pharmaceutical,
toxicological, preclinical, clinical, assay control, manufacturing, regulatory,
and any other information used or useful for the development, and/or regulatory
approval of Products or Services.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.24. |
“Rosetta
Genomics Patent Rights”
shall mean United States and foreign patents and patent applications
(which shall be deemed to include certificates of invention and
applications for certificates of invention) which as of the Effective
Date
or at any time during the term of this
Agreement
|
(i) |
are
owned by Rosetta Genomics or which Rosetta Genomics through license
or
otherwise has or acquires rights (and is not prohibited from sublicensing
to US Genomics); and
|
(ii) |
relate
in any way to Products, Services or any Improvement or otherwise
relate to
Information and Inventions, including all certificates of invention,
divisions, continuations, continuations-in-part, reissues, renewals,
extensions, supplementary protection certificates or the like of
any such
patents and current and future patent applications, and any counterparts
thereof which may be filed in other countries. Any Rosetta Genomics
Patent
Rights and any subsequent changes thereto shall be attached hereto
as
Exhibit C, provided, however, that the failure to include the then
current
Rosetta Genomics Patent Rights in Exhibit C from time to time shall
not
affect the Parties’ respective rights and obligations under this
Agreement.
|
1.25. |
“Royalty
Year”
shall mean (i) for the year in which the First Commercial Sale occurs,
the
period commencing with the date of such First Commercial Sale and
expiring
on the last day of the Calendar Quarter in which the twelfth (12th)
month
following the date of the First Commercial Sale occurs and (ii) for
each
subsequent year, each successive twelve (12) month
period.
|
1.26. |
“SEC”
means the United States Securities and Exchange
Commission.
|
1.27. |
“Services”
means any service performed using the US Genomics Platform in the
Field.
|
1.28. |
“Sublicense”
shall mean a sublicense by Rosetta Genomics to a Third Party granted
in
accordance with Section 2.3 of this
Agreement.
|
1.29. |
“Sublicense
Income”
shall mean all license fees and milestone payments and other payments
paid
by a Sublicensee to Rosetta Genomics in consideration of the grant
of a
Sublicense to such Sublicensee, excluding royalties, equity investments
in
Rosetta Genomics at fair market value, research funding paid to Rosetta
Genomics at cost or loans to Rosetta Genomics from the Sublicensee
on
commercial arms length terms.
|
1.30. |
“Sublicensee”
shall mean a sublicensee who was granted a Sublicense from Rosetta
Genomics.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.31. |
“Territory”
shall mean all the countries in the
world.
|
1.32. |
“US
Genomics Based Product”
shall mean any product or service sold for use in the Field whose
manufacture, use or sale in the Field is covered by one or more Valid
Claims, where the Early Detection is made using the US Genomics
Platform.
|
1.33. |
“US
Genomics Know-How”
shall mean any and all US Genomics Information and Inventions, and
all
other information and materials, including but not limited to,
discoveries, information, Improvements, processes, formulas, data,
inventions, know-how and trade secrets, patentable or otherwise,
which in
all cases
|
(i) |
relate
to Products, Services or the use of the US Genomics Platform in the
Field;
and
|
(ii) |
are
in US Genomics’ possession or control as of and after the date hereof and
as to which US Genomics has the right to license or sublicense to
third
parties, and are necessary or useful to Rosetta Genomics in connection
with the rights granted and activities contemplated under this
Agreement.
|
Such
know-how shall include, without limitation, all biological, chemical,
pharmaceutical, toxicological, preclinical, clinical, assay control, regulatory,
and any other information used or useful for the development, manufacturing
and/or regulatory approval of Products or Services.
1.34. |
“US
Genomics Patent Rights”
shall mean United States and foreign patents and patent applications
(which shall be deemed to include certificates of invention and
applications for certificates of invention) which as of the Effective
Date
or at any time during the term of this
Agreement
|
(i) |
are
owned by US Genomics or jointly owned by US Genomics and Rosetta
Genomics
or which US Genomics through license or otherwise has or acquires
rights
(and is not prohibited from sublicensing to Rosetta Genomics);
and
|
(ii) |
relate
in any way to the Products, Services, the use of the US Genomics
Platform
in the Field and/or any Improvement, or otherwise relate to Information
and Inventions, including all certificates of invention, divisions,
continuations, continuations-in-part, reissues, renewals, extensions,
supplementary protection certificates or the like of any such patents
and
current and future patent applications, and any counterparts thereof
which
may be filed in other countries, and additional patents or patent
applications which arise as a result of research and development
of the
Products and Services under this Agreement. US Genomics Patent Rights,
as
of the Effective Date, consist of the patents and patent applications
listed on Exhibit B hereto. Any subsequent US Genomics Patent Rights
and
any changes to any US Genomics Patent Rights shall be added to Exhibit
B,
provided, however, that the failure to include the then current US
Genomics Patent Rights in Exhibit B from time to time shall not affect
the
Parties’ respective rights and obligations under this
Agreement.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.35. |
“US
Genomics Platform”
means the platform developed by US Genomics for the detection and
quantitation of single molecules.
|
1.36. |
“Third
Party”
shall mean a person or entity who or which is neither a Party nor
an
Affiliate of a Party.
|
1.37. |
“Valid
Claim”
means a claim of an issued and unexpired patent or patent application
included within the US Genomics Patent Rights, which has not been
revoked
or held unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or for
which
an appeal has not been filed within the time allowed for appeal,
and which
has not been disclaimed, denied or admitted to be invalid or unenforceable
through reissue or disclaimer or
otherwise.
|
1.38. |
“Additional
Definitions”
In addition, each of the following definitions shall have the respective
meanings set forth in the section of this Agreement indicated
below:
|
Definition
|
Section
|
Claims
|
10.1
|
Disputed
Matter
|
11.6
|
Indemnified
Party
|
10.1
|
Indemnifying
Party
|
10.2
|
Joint
Information and Inventions
|
3.6(iii)
|
Losses
|
10.1.1
|
Quarterly
Report
|
5.2
|
Recipient
Party
|
3.1(v)
|
Rosetta
Genomics Information and Inventions
|
3.6(ii)
|
Transferring
Party
|
3.1(v)
|
US
Genomics Information and Inventions
|
3.6(i)
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ARTICLE
II
LICENSE;
SUBLICENSES
2.1. |
License
Grant.
|
2.1.1 |
US
Genomics hereby grants to Rosetta Genomics a non-exclusive, worldwide
license, under the US Genomics Patent Rights and the US Genomics
Know How,
and the US Genomics Improvements (as such term is defined under Section
3.5.(i)), including the right to grant sublicenses on the terms set
forth
herein, to (a) use the US Genomics Platform for internal research
for the
purpose of developing Products and Services, and (b) to develop,
use,
import, offer for sale, market, commercialize, manufacture, distribute
and
sell the Products and the Services in the Territory, both solely
for the
Field.
|
2.1.2 |
US
Genomics hereby grants to Rosetta Genomics a worldwide, royalty-free,
paid-up, non-exclusive license, without the right to sublicense,
under the
US Genomics Know-How and the US Genomics Patent Rights solely as
required
in order for Rosetta Genomics to carry out its obligations and
responsibilities under the Development
Plan.
|
2.2. |
US
Genomics hereby grants to Rosetta Genomics a worldwide, royalty-free,
paid-up, non-exclusive license, with the right to grant sublicenses,
under
the US Genomics Information and Inventions solely to the extent that
the
US Genomics Information and Inventions constitute an improvement
to or
modification of Rosetta Genomics Know-Flow or Rosetta Genomics Patent
Rights for use by Rosetta Genomics solely in connection with the
practice
of the Rosetta Genomics Know-flow and Rosetta Genomics Patent Rights.
License Grant by Rosetta Genomics
|
2.2.1 |
Rosetta
Genomics hereby grants to US Genomics a worldwide, royalty-free,
paid-up,
non-exclusive license, without the right to sublicense, under the
Rosetta
Genomics Know-How, the Rosetta Genomics Patent Rights and the Rosetta
Genomics Improvement (as such term is defined under section 3.5(ii)),
solely as required in order for US Genomics to carry out its obligations
and responsibilities under the Development
Plan.
|
2.2.2 |
Rosetta
Genomics hereby grants to US Genomics a worldwide, royalty-free,
paid-up,
non-exclusive license, with the right to grant sublicenses, under
the
Rosetta Genomics Information and Inventions solely to the extent
that the
Rosetta Genomics Information and Inventions constitute an improvement
to
or modification of US Genomics Know-How or US Genomics Patent Rights
for
use by US Genomics solely in connection with the practice of the
US
Genomics Know-How and US Genomics Patent
Rights.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
2.3. |
Retained
Rights.
Except as specifically set forth herein, Rosetta Genomics is not
granted
any other license by implication or otherwise. US Genomics shall
retain
the right to use the US Genomics Know-How and US Genomics Patent
Rights
for all purposes inside or outside the
Field.
|
2.3.1 |
Except
as specifically set forth herein, US Genomics is not granted any
other
license by implication or otherwise. Rosetta Genomics shall retain
the
right to use the Rosetta Genomics Know-How and Rosetta Genomics Patent
Rights for all purposes inside or outside the
Field.
|
2.4. |
Sublicenses.
Subject to compliance with the provisions of this Agreement, Rosetta
Genomics shall have the right to grant sublicenses to any Third Party
under the US Genomics Know How and US Genomics Patent Rights in the
Field
in the Territory, with the consent of US Genomics, such consent not
to be
unreasonably withheld. Any grant by Rosetta Genomics of a Sublicense
shall
be consistent with the terms of this
Agreement.
|
ARTICLE
III
DEVELOPMENT
AND COMMERCIALIZATION
3.1. |
Diligence;
Development and
Commercialization
|
(i) |
Mutual
Responsibilities of the Parties.
The initial Development Plan covering the activities to be carried
out by
the Parties under this Agreement is attached hereto as Exhibit
A.
The parties shall use commercially reasonable efforts to complete
the
Development Plan activities on the timelines specified therein. The
Parties may, by mutual agreement, make adjustments and amendments
to the
Development Plan as reasonably required during the term of this Agreement,
which adjustments and amendments shall be attached as an addendum
to
Exhibit
A.
Each adjustment and amendment to the Development Plan shall be in
writing
and shall: (a) set forth (i) the activities to be performed with
reasonable specificity and the anticipated timeline for such activities,
provided however that such timeline shall not obligate the Parties,
and
(ii) the Party that shall be responsible for performing such activities;
and (b) be consistent with the terms of this Agreement. Each Party
agrees
to use commercially reasonable efforts to perform its respective
activities under the Development Plan, with the goal of developing
Products and Services. Without limiting the foregoing, each Party
shall
(A) commit such scientific resources, including, but not limited
to
consultants, facilities, equipment, and Proprietary Materials, as
are
reasonably necessary to achieve the objectives of the Development
Plan and
(B) perform its obligations under the Development Plan in good scientific
manner and in compliance in all material respects with all applicable
laws.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(ii) |
Rosetta
Genomics’ Responsibilities.
In addition to the other obligations of Rosetta Genomics set forth
in this
Agreement, Rosetta Genomics shall be responsible
to:
|
(1) |
Obtain
all clinical samples required in the course of the Development
Plan;
|
(2) |
Undertake
the experimental work required under Phase Ia, Phase Ib and Phase
II of
the Development Plan, either by itself or, through a sublicensee
or a
sub-contractor;
|
(3) |
Provide
US Genomics with purified RNA for use in Phase Ic and Phase 2 of
the
Development Plan; and
|
(4) |
Fund
and perform Phase III of the Development Plan on the US Genomics
Platform.
Rosetta Genomics may, negotiate third party support for some or all
of
Phase III and any subsequent clinical/regulatory
development.
|
(iii) |
US
Genomics’ Responsibilities.
In addition to the other obligations of US Genomics set forth in
this
Agreement, US Genomics shall be responsible
to:
|
(1) |
Undertake
associated experimental work during all clinical phases as set forth
in
the Development Plan;
|
(2) |
Fund
and support any required placement of instruments and reagents during
the
Development Plan including the supply and maintenance of [***] US
Genomics
Platform together with reagents necessary for [***] samples in Phases
I
and II, and [***] additional US Genomics Platforms together with
reagents
necessary for [***] samples in Phase III, with all US Genomics Platforms
being provided and supported at a facility mutually agreed upon by
both
Parties ; and
|
(3) |
Fund
and perform any commercially reasonable platform development work
necessary for the development of the
project.
|
(iv) |
Cooperation.
The Parties acknowledge that the implementation of the Development
Plan
will require cooperation of the Parties and, in connection therewith,
agree to cooperate in the performance of the Development Plan and,
subject
to the terms of this Agreement and any confidentiality obligations
to
Third Parties, shall exchange in a timely fashion such data, information
and materials as are reasonably necessary for the other Party to
perform
its obligations under the Development
Plan.
|
(v) |
Records.
Each Party shall maintain records of its activities under the Development
Plan in sufficient detail, in good scientific manner and otherwise
in a
manner that reflects all work done and results achieved in the performance
of the Development Plan. Without limiting the generality of this
Section
3.1(iii), each Party agrees to maintain a policy that requires its
employees and consultants to record and maintain all data and information
developed under the Development Plan in a manner designed to enable
the
Parties to use such records to establish the earliest date of invention
or
reduction to practice.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(vi) |
Reports
and Data.
Each Party shall keep the other Party regularly informed of the progress
of the Development Plan. Without limiting the generality of the foregoing,
the Parties shall, not less than once each Calendar Quarter during
the
Term (and more frequently if required to keep the other Party sufficiently
informed), provide to the other Party (i) reports in reasonable detail
regarding the status of each Party’s activities under the Development Plan
and (ii) such supporting data and information as may be reasonably
requested from time to time by the other Party regarding the Development
Plan.
|
(vii) |
Supply
of Proprietary Materials.
From time to time during the Term, in addition to the supply of reagent
kits as set forth in Section 3.1(iii), each Party (the “Transferring
Party”) shall supply the other Party (the “Recipient Party”), at its sole
expense, with Proprietary Materials of the Transferring Party for
use in
the Development Program as specified in the Development Plan. In
connection therewith, each Recipient Party hereby agrees that (a)
it shall
not use such Proprietary Materials for any purpose other than exercising
its rights or performing its obligations hereunder; (b) it shall
use such
Proprietary Materials only in compliance with all applicable laws;
(c) it
shall not transfer any such Proprietary Materials to any Third Party
without the prior written consent of the Transferring Party, except
as
expressly permitted hereby; (d) the Recipient Party shall not acquire
any
right, title or interest in or to such Proprietary Materials as a
result
of such supply by the Transferring Party except as expressly set
forth
herein; and (e) upon the expiration or termination of the Term, the
Recipient Party shall, if and as instructed by the Party, either
destroy
or return any such Proprietary Materials that are not the subject
of the
grant of a continuing license
hereunder.
|
(viii) |
Expenses.
Except as expressly set forth herein, each Party shall bear its own
costs
and expenses in the performance of the Development
Plan.
|
3.2. |
Regulatory
Matters.
Rosetta Genomics shall own, control and retain primary legal
responsibility for the preparation, filing and prosecution of all
filings
and regulatory applications required to obtain and maintain authorization
to develop, sell and use Products and/or Services in the Field in
the
countries throughout the Territory. Rosetta Genomics shall provide
to US
Genomics all filings, material correspondence and other documentation
in
connection with such applications and authorization in sufficiently
timely
fashion to permit US Genomics to review and comment on such materials
and
shall reasonably consider any such comments. The Supply Agreement
to be
negotiated pursuant to Article IX will provide that US Genomics will
comply with all regulatory requirements with respect to the manufacture
of
US Genomics Based Products and the US Genomics Platform, including,
without limitation, the QSR/GMP requirements set forth in 21CFR Part
820.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
3.3. |
Trademark.
Rosetta Genomics or any Sublicensee shall, as applicable and determined
by
Rosetta Genomics, select, own and maintain, at its expense, trademarks
for
all Products and Services.
|
3.4. |
Exchange
of Information
|
Each
Party shall disclose to the other Party in English and in writing all Know-How
of such Party not previously disclosed to the other Party that is necessary
or
useful for the conduct of the Development Plan and/or the commercialization
of
Products and the US Genomics Platform. Throughout the term of this Agreement,
and in addition to the other communications required under this Agreement,
each
Party shall also promptly disclose to the other party in English and in writing
on an ongoing basis all Know-How of such Party and other information developed
in connection with the Parties’ activities under this Agreement. Throughout the
term of this Agreement, and in addition to the other communications required
under this Agreement, each Party shall promptly disclose to the other Party
in
English and in writing all Know-How of such Party and other information
developed in connection with such Parties’ activities under this
Agreement.
3.5. |
Information
and Inventions.
Ownership of Information and Inventions developed or invented, or
which
are discovered or which accrue in the course of or which arise or
stem
from the performance of research and development under this Agreement,
and
all patent and other intellectual property rights relating thereto
shall
be determined as follows:
|
(i) |
such
Information and Inventions that are solely related to, improvements
to or
modifications of US Genomics Know-How or US Genomics Patent Rights
shall
be owned solely by US Genomics, (“US Genomics
Improvements”);
|
(ii) |
such
Information and Inventions that are solely related to, improvements
to or
modifications of Rosetta Genomics Know-How or Rosetta Genomics Patent
Rights shall be owned solely by Rosetta Genomics (“Rosetta Genomics
Improvements”);
|
(iii) |
such
Information and Inventions that are not described in clauses (i)
or (ii)
above and that are developed or invented, or which accrue in the
course of
or which arise or stem from the performance of research and development
under this Agreement solely by employees, agents, or consultants
of US
Genomics shall be owned solely by US Genomics (“US Genomics Information
and Inventions”)
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(iv) |
such
Information and Inventions that are not described in clauses (i)
or (ii)
above and that are developed or invented, or which accrue in the
course of
or which arise or stem from the performance of research and development
under this Agreement solely by employees, agents, or consultants
of
Rosetta Genomics shall be owned solely by Rosetta Genomics (“Rosetta
Genomics Information and
Inventions”)
|
(v) |
such
Information and Inventions that are not described in clauses (i)
or (ii)
above and that are developed or invented, or which accrue in the
course of
or which arise or stem from the performance of research and development
under this Agreement jointly by employees, agents or consultants
of US
Genomics and Rosetta Genomics shall be owned jointly by US Genomics
and
Rosetta Genomics; (“Joint Information and Inventions”), subject to the
rights of, and the licenses granted to, each Party hereunder.
Notwithstanding anything to the contrary contained herein or under
applicable law, the Parties hereby agree that either Party may use
or
license or sublicense to Affiliates or third parties all or any portion
of
its interest in Joint Information and Inventions for any purposes
outside
the Field without the prior written consent of the other Party, without
restriction and without the obligation to provide compensation to
the
other Party.
|
Each
Party shall promptly disclose to the other Party the development, making
conception or reduction to practice of Information and Inventions, subject
to
the other provisions of this Agreement, and each Party shall execute and deliver
any necessary assignments and other instruments and take any additional actions
as may be requested by the other Party to effect the provisions of clauses
(i)
and (ii) of this Subsection.
Inventorship
shall be determined in accordance with United States law, and, notwithstanding
any other provision of this Agreement, disputes regarding the treatment of
Information and Inventions under this Section shall be resolved by an
independent patent counsel mutually agreeable to the Parties, the costs of
which
shall be borne equally by the Parties.
3.6. |
Negotiation
outside the Field.
At the request of either Party, both Parties will negotiate in good
faith
with respect to a possible collaboration to develop products and
services
utilizing the US Genomics US Genomics Platform or a modification
thereof
for specific diseases outside the Field. Neither Party shall be obligated
to enter into any such agreement with the
other.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ARTICLE
IV
CONFIDENTIALITY
AND PUBLICITY
4.1. |
Non-Disclosure
and Non-Use Obligations
|
All
Proprietary Information disclosed by one Party to the other Party hereunder
shall be maintained in confidence and shall not be disclosed to any Third Party
or used for any purpose except as expressly permitted herein without the prior
written consent of the Party that disclosed the Proprietary Information to
the
other Party. The foregoing non-disclosure and non-use obligations shall not
apply to the extent that such Proprietary Information:
(i) |
is
known by the receiving Party at the time of its receipt, and not
through a
prior disclosure by the disclosing Party, as documented by contemporaneous
written records;
|
(ii) |
is
in the public domain or knowledge;
|
(iii) |
is
subsequently disclosed to a receiving Party by a Third Party who
may
lawfully do so and is not under an obligation of confidentiality
to the
disclosing Party; or
|
(iv) |
is
developed by the receiving Party independently of Proprietary Information
received from the other Party, as documented by contemporaneous research
and development records.
|
4.2. |
Permitted
Disclosure of Proprietary Information.
|
Notwithstanding
Section 4.1, a Party receiving Proprietary Information of another Party may
disclose such Proprietary Information:
(i) |
to
governmental or other regulatory agencies in order to obtain patents
on
Products or Services, or to gain approval to conduct clinical trials
or to
market Products and Services to the extent permitted hereunder, but
such
disclosure may be only to the extent reasonably necessary to obtain
such
patents or authorizations;
|
(ii) |
to
its respective agents, consultants, Affiliates, sublicensees and/or
other
Third Parties for the research and development, manufacturing and/or
marketing of Products or Services (or for such parties to determine
their
interests in performing such activities) on the condition that such
Third
Parties agree to be bound by the confidentiality obligations contained
in
this Agreement; or
|
(iii) |
if
required to be disclosed by law or court order, provided that notice
is
promptly delivered to the disclosing Party in order to provide an
opportunity to challenge or limit the disclosure obligations; provided,
however,
without limiting any of the foregoing, it is understood that either
Party
or its Affiliates may make disclosure of this Agreement and the terms
hereof in any filings required by the SEC, may file this Agreement
as an
exhibit to any filing with the SEC and may distribute any such filing
in
the ordinary course of its business. However, to the maximum extent
allowable by SEC rules and regulations, the Parties shall be obligated
to
maintain the confidentiality obligations set forth herein and shall
redact
any confidential information set forth in such filings as may be
reasonably requested by the disclosing
Party.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
4.3. |
Publication.
During the term of this Agreement, US Genomics and Rosetta Genomics
each
acknowledge the other Party’s interest in issuing press releases and
publishing its results related to the Products and Services for marketing
purposes and to obtain recognition within the scientific community
and to
advance the state of scientific knowledge. Each Party also recognizes
the
mutual interest in obtaining valid patent protection and in protecting
business interests and trade secret information. Consequently, either
Party, its employees or consultants wishing to make a publication
shall
deliver to the other Party a copy of the proposed written publication
or
an outline of the proposed oral disclosure at least thirty (30) days
prior
to submission for publication or presentation in the case of a publication
or presentation and at least five (5) days prior to release in the
case of
a press release. The other Party shall have the right (a) to propose
modifications to the publication, presentation or press release for
scientific reason, patent reasons, trade secret reasons (including
disclosure of Proprietary Information) or business reasons or (b)
to
request a reasonable delay in publication, presentation or issue
of the
press release in order to protect patentable information. If the
other
Party requests a delay, the publishing Party shall delay submission
or
presentation for a period of thirty (30) days (or five (5) days in
the
case of a press release) to enable patent applications protecting
each
Party’s rights in such information to be filed and the redaction of
Proprietary Information. Upon expiration of such thirty (30) days
or five
(5) days, the publishing Party shall be free to proceed with the
publication, presentation or issue of the press release, but may
not
include Proprietary Information of the other Party unless it is within
an
exception of Section 4.1(i) through 4.1(iv). If the other Party requests
modifications to the publication, presentation or press release,
the
publishing Party shall edit such publication, presentation or press
release to prevent disclosure of trade secret or Proprietary Information
prior to submission of the publication or presentation or issue of
the
press release.
|
ARTICLE
V
PAYMENTS,
ROYALTIES AND REPORTS
5.1. |
Royalties
to US Genomics
|
(i) |
Subject
to the terms and conditions of this Agreement, and in consideration
of the
rights granted by US Genomics hereunder, Rosetta Genomics shall pay
to US
Genomics royalties in an amount equal to the following percentages
of
annual Net Sales by Rosetta Genomics or its Affiliates of any US
Genomics
Based Products and/or Services within the Field in the Territory
in each
Royalty Year:
|
Amount
of Net Sales
|
Royalty
Rate
|
Up
to and including US$[***] million
|
[***]%
|
Above
US$[***] million up to and including US$[***] million
|
[***]%
|
Above
US$[***] million
|
[***]%
|
(ii) |
Subject
to the terms and conditions of this Agreement, and in consideration
of the
rights granted by US Genomics hereunder, Rosetta Genomics shall pay
to US
Genomics royalties in an amount equal to the following percentages
of
annual Net Sales by Rosetta Genomics or its Affiliates of any US
Genomics
Based Products and/or Services within the Field in the Territory
in each
Royalty Year
|
Amount
of Net Sales
|
Royalty
Rate
|
Up
to and including US$[***] million
|
[***]%
|
Above
US$[***] million up to and including US$[***] million
|
[***]%
|
Above
US$[***] million up to and including US$[***] million
|
[***]%
|
Above
US$[***] million
|
[***]%
|
(iii) |
Subject
to the terms and conditions of this Agreement, and in consideration
of the
rights granted by US Genomics hereunder, Rosetta Genomics will pay US
Genomics an amount equal to the following percentages of all royalties
received from Sublicensees with respect to sale of US Genomics Based
Products and/or Services by Sublicensees within the Field in the
Territory
in each Royalty Year:
|
Amount
of Net Sales on which royalties are paid to
|
Percentage
of
|
Rosetta
Genomics by Sublicensees
|
Sublicensee
|
|
Royalty
to
|
|
Be
paid to U.S
|
|
Genomics
|
Up
to and including US$[***] million
|
[***]%
|
Above
US$[***] million up to and including US$[***] million
|
[***]%
|
Above
US$[***] million
|
[***]%
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(iv) |
Subject
to the terms and conditions of this Agreement, and in consideration
of the
rights granted by US Genomics hereunder, Rosetta Genomics will
pay US
Genomics an amount equal to the following percentages of all royalties
received from Sublicensees with respect to sale of Other US Genomics
Patented Products by Sublicensees within the Field in the Territory
in
each Royalty Year:
|
Amount
of Net Sales on which royalties are paid to
|
Percentage
of
|
Rosetta
Genomics by Sublicensees
|
Sublicensee
|
|
Royalty
to
|
|
Be
paid to U.S
|
|
Genomics
|
Up
to and including US$[***] million
|
[***]%
|
Above
US$[***] million up to and including US$[***] million
|
[***]%
|
Above
US$[***] million up to and including US$[***] million
|
[***]%
|
Above
US$[***] million
|
[***]%
|
(v) |
In
the event Rosetta Genomics or any of its Affiliates pays royalties
on Net
Sales in excess of [***] percent ([***]%) in the aggregate to US
Genomics
and one or more Third Parties to obtain rights that are determined
to be
necessary, based on the advice of patent counsel to Rosetta Genomics,
with
respect to the sale of any Product or Service in the Field, Rosetta
Genomics shall have the right to reduce the amount of royalties owing
to
US Genomics under Section 5.1(i), (ii), (iii) or (iv) by [***] percent
([***]%) of the amount by which such aggregate royalties to US Genomics
and such Third Party or Third Parties exceeds [***] percent ([***]%)
of
Net Sales; provided,
however,
that, the royalty paid to US Genomics shall not be reduced by operation
of
this Section 5.1(v) by more than [***] percent ([***]%) of what would
otherwise be owed under Section 5.1(i), (ii), (iii) or (iv). For
example,
if Net Sales by Rosetta Genomics and its Affiliates under Section
5.1(i)
were $[***] million, and Rosetta Genomics paid a royalty equal to
[***]
percent ([***]%) of Net Sales to a Third Party, then the royalty
paid by
Rosetta Genomics to US Genomics on the first $[***] million of Net
Sales
would not be reduced; the royalty paid by Rosetta Genomics to US
Genomics
on the second $[***] million of Net Sales would be reduced by [***]
of
[***] percent ([***]%) and the royalty paid by Rosetta Genomics to
US
Genomics on the last $[***] million of Net Sales would be reduced
by [***]
percent ([***]%).
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(vi) |
In
the event that as a result of the sale by Rosetta Genomics of any
Product
or Service, US Genomics is required to pay royalties to any Third
Party in
consideration for the license of patent rights then Rosetta Genomics
will
reimburse US Genomics for [***] percent ([***]%) of such payment
so long
as such reimbursement, together with all royalties paid to US Genomics
and
Third Parties (including amounts reimbursed by Rosetta Genomics pursuant
to this Section) by Rosetta Genomics or any of its Affiliates with
respect
to the sale of such Product or Service, does not exceed [***] percent
([***]%) of Net Sales in the aggregate. To the extent such reimbursement
and royalties would exceed [***] percent ([***]%) of Net Sales in
the
aggregate, Rosetta Genomics shall instead reimburse US Genomics for
[***]
percent ([***]%) of such payment by US Genomics to the Third Parties.
Notwithstanding the foregoing, in no event shall the amount payable
by
Rosetta Genomics under this Section 5.1(vi) with respect to the sale
of
any Product or Service exceed [***] percent ([***]%) of the Net Sales
thereof.
|
As
a
first example, if the Rosetta royalty obligation to US Genomics was [***]%
and
Rosetta was required to pay an [***]% royalty for necessary 3rd
party
rights, it would be entitled to deduct [***]% ([***]% of [***]%) from the amount
owed to US Genomics. However, if US Genomics was also obligated to pay [***]%
to
another 3rd
party,
Rosetta would reimburse [***]% ([***]% of [***]%) of this to US Genomics. Under
this combined scenario, US Genomics would net [***]% of sales ([***] - [***]
-
[***] +[***]). Rosetta’s total royalty obligation would be [***]% ([***] + [***]
- [***] + [***]).
As
a
second example, if the Rosetta royalty obligation to US Genomics was [***]%
and
Rosetta was required to pay a [***]% royalty for necessary 3rd
party
rights and US Genomics was obligated to pay [***]% to another 3rd
party,
US Genomics would net [***]% of sales ([***] - [***] +[***]) and Rosetta’s total
royalty obligation would be [***]% ([***] + [***] + [***]).
(vii) |
Royalties
on Net Sales, at the rates set forth above, shall accrue as of the
date of
the applicable First Commercial Sale in any country and shall continue
and
accrue on Net Sales (a) in a country where a Valid Claim included
within
the US Genomics Patent Rights exists, until the later of the date
of
expiry of such patent in such country or the expiry of the period
of
twelve (12) years commencing with the date of the First Commercial
Sale
(b) in any other country, until the expiry of the period of twelve
(12)
years commencing with First Commercial Sale in such
country.
|
(viii) |
Following
the expiration of the last applicable period set forth in subsection
(v)
above, (a) Rosetta Genomics shall have the right under this Agreement
to
directly and indirectly (through sublicensees or otherwise) continue
to
manufacture, use, market, commercialize, distribute and sell and
otherwise
dispose of Products and Services, throughout the world, without having
to
pay royalties or any other consideration to US Genomics and (b) US
Genomics shall not grant any exclusive license to the US Genomics
Know How
to any Third Party for the Field.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(ix) |
Rosetta
Genomics shall have the right, at any time and in its sole discretion,
to
terminate its obligation to make any further payment to US Genomics
under
this Article 5 by paying to US Genomics the sum of [***] Dollars
($[***])
less all amounts previously paid to US Genomics
hereunder.
|
(x) |
In
the event that (i) Rosetta Genomics does not commercialize either
any US
Genomics Based Product or any Other US Genomics Patented Product,
and (ii)
Rosetta Genomics commercializes a product or service for Early Detection
of Lung Cancer based on microRNA markers in sputum and/or blood that
is
not a US Genomics Based Product or an Other US Genomics Patented
Product,
then Rosetta Genomics will pay US Genomics [***] percent ([***]%)
of the
direct cost to US Genomics of the US Genomics Platforms and reagent
kits
provided to Rosetta Genomics for use in the Development Program pursuant
to Section 3.1(iii), such payment to be made on the first anniversary
of
the first commercial sale of the first such product or
service.
|
5.2. |
Sublicense
Income.
Rosetta Genomics will pay US Genomics [***]% of all Sublicense Income
received from Sublicensees in each Calendar
Quarter.
|
5.3. |
Reports;
Payment of Royalty.
Commencing with the first Calendar Quarter in which royalty or other
payments are due, Rosetta Genomics shall furnish to US Genomics a
quarterly written report for such Calendar Quarter (the “Quarterly
Report”), each showing the sales of all Products and Services subject to
royalty or other payments sold by Rosetta Genomics and its Affiliates
and
all Sublicense Income and royalties received from Sublicensees during
the
reporting period and the royalties or other payments payable under
this
Agreement. Quarterly Reports shall be due on the sixtieth (60th)
day
following the close of each Calendar Quarter. Royalties and other
payments
shown to have accrued by each Quarterly Report, if any, shall be
due and
payable on the date such Quarterly Report is due. Rosetta Genomics
shall
keep (and shall require its Affiliates to keep) complete and accurate
records in sufficient detail to enable Net Sales and the royalties
and
other payments payable hereunder, to be determined, reconciled and
verified.
|
5.4. |
Audits.
|
5.4.1 |
Upon
the written request of US Genomics and not more than once in each
Calendar
Year, Rosetta Genomics shall permit an independent certified public
accounting firm of recognized standing in the United States or Israel,
selected by US Genomics and reasonably acceptable to Rosetta Genomics,
to
have access during normal business hours at times mutually convenient
to
the Parties and upon reasonable notice to Rosetta Genomics to such
of the
records of Rosetta Genomics as may be reasonably necessary to verify
the
accuracy of the royalty and other payment reports hereunder for any
Royalty Year, for a period of up to three (3) years from the completion
of
such Royalty Year. The accounting firm shall report to US Genomics
only
the results of the work performed as contemplated by this Section
5.4.1
and the details concerning any
discrepancies.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
5.4.2 |
If
such accounting firm concludes that additional royalties or other
payments
were owed during such Royalty Year , Rosetta Genomics shall pay the
additional royalties or other payments (plus accrued interest at
the LIBOR
rate as in effect on the date that such payment was first due, plus
[***]
([***]%) percent) within ten (10) Business Days of the date US Genomics
delivers to Rosetta Genomics such accounting firm’s written report so
concluding, provided however, that in the event that Rosetta Genomics
shall not be in agreement with the conclusions of such report Rosetta
Genomics shall provide US Genomics with a written notice to such
effect
within such ten (10) Business Day period and such matter shall be
resolved
pursuant to the provisions of Section 11.6. In the event such accounting
firm concludes that Rosetta Genomics overpaid amounts during such
period,
US Genomics shall reimburse Rosetta Genomics the amount of such
overpayment within ten (10) Business Days of receipt of such accounting
firm’s written report, provided however, that, in the event that US
Genomics shall not be in agreement with the conclusions of such report
US
Genomics shall provide Rosetta Genomics with a written notice to
such
effect within such ten (10) Business Day period and such matter shall
be
resolved pursuant to the provisions of Section 11.6. The fees charged
by
such accounting firm shall be paid by US Genomics unless the audit
(or in
the case of a disagreement, the dispute resolution under Section
11.6)
establishes an underpayment by Rosetta Genomics of [***] percent
([***]%)
or more.
|
5.4.3 |
Each
Party reviewing information under this Section 5.4 shall treat all
financial information subject to review under this Section 5.4 in
accordance with the confidentiality provisions of this Agreement
and shall
request a confidentiality agreement to the same effect from any accounting
firm reviewing information under this Section
5.4.
|
5.5. |
Payments.
All payments to be made under this Agreement shall be made in United
States Dollars and shall be paid by bank wire transfer or by automated
clearinghouse (electronic funds transfer) in immediately available
funds
to such bank account designated in writing by each Party to the other
from
time to time. Bank charges necessary for making the bank transfer
shall be
incurred by the Party making the
transfer.
|
5.6. |
Payment
Exchange Rate.
In the case of sales outside the United States, the rate of exchange
to be
used in computing the amount of currency equivalent in United States
dollars due any Party shall be calculated quarterly in accordance
with
GAAP and based on the conversion rates for buying United States dollars
on
the last Business Day of each Calendar Quarter published in the Wall
Street Journal, Eastern edition.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
5.7. |
Tax
Withholding.
The royalties, milestones and other amounts payable by Rosetta Genomics
to
US Genomics pursuant to this Agreement (“Payments”)
shall not be reduced on account of any taxes and are net of all such
taxes. US Genomics alone shall be responsible for paying any and
all taxes
(other than withholding taxes or deduction of tax at source required
by
applicable law to be paid by Rosetta Genomics) levied on it by account
of
its receipt of any Payments it receives under this
Agreement.
|
5.8. |
Interest
on Late Payments.
Except as otherwise set forth in this Agreement, any payment by Rosetta
Genomics that is not paid on or before the date such payment is due
under
this Agreement shall bear interest, to the extent permitted by applicable
law, at a rate per annum equal to the LIBOR rate as in effect on
the date
that such payment was first due, plus [***] percent ([***]%) calculated
on
the number of days such payment is
delinquent.
|
5.9. |
Blocked
Currencies.
If by law, regulations or fiscal policy of a particular country in
the
Territory, remittance of royalties in United States Dollars is restricted
or forbidden, written notice thereof shall promptly be given to US
Genomics, and payment of the royalty shall be made by the deposit
thereof
in local currency to the credit of US Genomics in a recognized banking
institute reasonably designated by US Genomics by written notice
to
Rosetta Genomics. When in any country in the Territory the law or
regulations prohibit both the transmittal and the deposit of royalties
on
sales in such country, royalty payments shall be suspended for as
long as
such prohibition is in effect and as soon as such prohibition ceases
to be
in effect, all royalties that Rosetta Genomics would have been under
an
obligation to transmit or deposit but for the prohibition shall forthwith
be deposited or transmitted, to the extent
allowable.
|
ARTICLE
VI
REPRESENTATIONS
AND WARRANTIES
6.1. |
US
Genomics Representations and Warranties.
US Genomics represents and warrants to Rosetta Genomics that, as
of the
date hereof
|
(i) |
US
Genomics has the right to xxxxx Xxxxxxx Genomics the licenses granted
to
Rosetta Genomics in this Agreement;
|
(ii) |
this
Agreement has been duly executed and delivered by US Genomics and
constitutes its legal, valid, and binding obligation, enforceable
against
it in accordance with its terms;
|
(iii) |
no
approval, authorization, consent, or other order or action of or
filing
with any court, administrative agency or other governmental authority
is
required for the execution and delivery by it of this Agreement or
the
consummation by it of the transactions contemplated
hereby;
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(iv) |
to
its knowledge, it is the sole owner of all rights related to the
US
Genomics Know-How and US Genomics Patent Rights, free and clear of
all
liens, claims and pledges, security interest and restrictions to
the
extent that any of the foregoing would limit the rights granted
hereunder;
|
(v) |
to
its knowledge and except as otherwise disclosed in writing to Rosetta
Genomics, the use of the US Genomics Platform in the Field in the
Territory to the extent contemplated hereunder, will not infringe
any
patent right of any Third Party;
|
(vi) |
except
as otherwise disclosed in writing to Rosetta Genomics, it is under
no
liability or obligation to make any payments by way of royalties,
fees or
otherwise with respect to the use by Rosetta Genomics of US Genomics
Know-How and/or US Genomics Patent Rights, Products and/or
Services;
|
(vii) |
to
its knowledge, in the development of the US Genomics Know-How and/or
the
US Genomics Patent Rights, it did not wrongfully or illegally use
any
intellectual property rights of any entity or person, including any
former
or current employee;
|
(viii) |
it
has the full right, power and authority to enter into and deliver
this
Agreement, to perform and to grant the licenses granted under Article
II
hereof and to consummate the transactions contemplated hereby. All
corporate acts and other proceedings required to be taken to authorize
such execution, delivery, and consummation have been duly and properly
taken and obtained; and
|
(ix) |
there
are no actions, suits, proceedings, claims, judgments or settlements
against or owed by US Genomics or pending or threatened actions,
suits,
proceedings, claims or litigation against US Genomics relating to
the US
Genomics Patent Rights or US Genomics
Know-How.
|
6.2. |
US
Genomics’ Warranty Disclaimer
|
EXCEPT
AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, US GENOMICS MAKES NO WARRANTY,
EXPRESS OR IMPLIED, WITH RESPECT TO THE US GENOMICS PATENT RIGHTS, US GENOMICS
KNOW-HOW OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NON-INFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
6.3. |
Rosetta
Genomics’ Representations and Warranties.
Rosetta Genomics represents and warrants to US Genomics that as of
the
date hereof:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(i) |
Rosetta
Genomics has the right to grant US Genomics the licenses granted
to US
Genomics in this Agreement;
|
(ii) |
this
Agreement has been duly executed and delivered by Rosetta Genomics
and
constitutes its legal, valid, and binding obligations, enforceable
against
it in accordance with its terms;
|
(iii) |
it
has full corporate power and authority to execute and deliver this
Agreement and to consummate the transactions contemplated hereby.
All
corporate acts and other proceedings required to be taken to authorize
such execution, delivery, and consummation have been duly and properly
taken and obtained;
|
(iv) |
no
approval, authorization, consent, or other order or action of or
filing
with any court, administrative agency or other governmental authority
is
required for the execution and delivery by it of this Agreement or
the
consummation by it of the transactions contemplated
hereby;
|
(v) |
to
its knowledge, the use of the Rosetta Genomics Patent Rights in the
Field
in the Territory to the extent contemplated hereunder, will not infringe
any patent right of any Third Party;
and
|
(vi) |
except
as disclosed in writing it is under no liability or obligation to
make any
payments by way of royalties, fees or otherwise with respect to the
use of
the Rosetta Genomics Know-How and/or Rosetta Genomics Patent Rights
in the
development or commercialization of Products and/or
Services.
|
6.4. |
Rosetta
Genomics’ Warranty Disclaimer
|
EXCEPT
AS
OTIIERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, ROSETTA GENOM1CS MAKES NO
WARRANTY, EXPRESS OR IMPLIED, WITH RESPECT TO THE ROSETTA GENOMICS PATENT
RIGHTS, ROSETTA GENOMICS KNOW-HOW OR OTHER SUBJECT MATTER OF THIS AGREEMENT.
ROSETTA GENOMICS DOES NOT REPRESENT THAT IT CAN SUCCESSFULLY DEVELOP OR
COMMERCIALIZE ANY PRODUCT OR SERVICE.
ARTICLE
VII
PATENT
MATTERS
7.1. |
Filing,
Prosecution and Maintenance of Patent Applications or
Patents
|
7.1.1 |
Rosetta
Genomics Patent Rights.
Rosetta Genomics, acting through patent counsel of its choice, shall
be
responsible, at its sole expense, for the preparation, filing, prosecution
and maintenance of all Rosetta Genomics Patent Rights and patents
covering
Rosetta Genomics Improvements. At Rosetta Genomics’ request, US Genomics
shall cooperate with Rosetta Genomics in all reasonable respects,
at
Rosetta Genomics’ expense, in connection with such preparation, filing,
prosecution and maintenance of Rosetta Genomics Patent Rights and
Rosetta
Genomics Improvements.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
7.1.2 |
US
Genomics Patent Rights.
US Genomics, acting through patent counsel of its choice, shall be
responsible, at its own expense, for the preparation, filing, prosecution
and maintenance of all US Genomics Patent Rights and patents covering
US
Genomics Improvements. At US Genomics’ request, Rosetta Genomics shall
cooperate with and assist US Genomics in all reasonable respects,
at US
Genomics’ expense, in connection with such preparation, filing,
prosecution and maintenance of US Genomics Patent Rights and US Genomics
Improvements.
|
7.1.3 |
Joint
Program Patent Rights.
The Parties will cooperate to jointly select outside patent counsel
to
handle the filing, prosecution and maintenance of patents and patent
applications claiming Joint Information and Inventions. The Parties
shall
jointly determine which Party shall control the prosecution of patent
applications claiming inventions that are Joint Information and
Inventions. The fees of counsel and the other costs and expenses
related
to patents and patent applications claiming Joint Information and
Inventions shall be shared equally by the Parties. Should one Party
desire
not to share in the cost of any such patent or patent applications,
the
other Party shall gain sole control of the filing, prosecution and
maintenance of such patents or patent applications, which shall be
deemed
to be the Information and Inventions of such Party and such Party
shall
have sole responsibility for filing, prosecution and maintenance
expenses
with respect thereto.
|
7.1.4 |
Right
of Other Party to Prosecute and Maintain Patents.
Any Party having the first right to file, prosecute and maintain
the
patent applications and patents referred to in this Section 7.1 shall
give
notice to the other Party of any desire to cease prosecution and/or
maintenance of such patent rights and, in such case, shall permit
the
other Party, at its sole discretion, to continue prosecution and/or
maintenance at its own expense in the name of the first
Party.
|
7.2. |
Patent
Office Proceedings.
Each Party shall reasonably cooperate with the other Party with respect
to
any patent office proceeding.
|
7.3. |
Enforcement
and Defense.
|
7.3.1 |
Each
Party shall promptly give the other Party notice of any infringement
in
the Territory of any patent application or patent included in the
US
Genomics Patent Rights or Rosetta Genomics Patent Rights that comes
to
such Party’s attention. The Parties will thereafter consult and cooperate
fully to determine a course of action with respect to jointly owned
patent
rights, including, without limitation, the commencement of legal
action by
either Party. Each Party solely owning patent rights hereunder shall
have
the sole right to initiate and prosecute such legal action against
any
such infringer at its own expense in its own name or to control the
defense of any declaratory judgment action relating to such patent
rights.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
7.3.2 |
For
any such legal action or defense, in the event that any Party is
unable to
initiate, prosecute, or defend such action solely in its own name,
the
other Party shall join such action voluntarily and shall execute
all
documents reasonably necessary for the Party to prosecute, defend
and
maintain such action. In connection with any such action, the Parties
will
cooperate and will provide each other with any information or assistance
that either reasonably may request. Each Party shall keep the other
informed of developments in any such action or proceeding, including,
to
the extent permissible by law, the status of any settlement negotiations
and the terms of any offer related
thereto.
|
7.3.3 |
Any
recovery obtained by Rosetta Genomics or US Genomics in any such
action or
proceeding shall be shared as follows in the following order of
priority:
|
(i) |
the
Party that initiated and prosecuted or maintained the defense of,
the
action, shall recoup all of its costs and expenses incurred in connection
with the action, whether by settlement or
otherwise;
|
(ii) |
the
other Party shall next recoup all of its costs and expenses incurred
in
connection with the action, whether by settlement or
otherwise;
|
(iii) |
if
US Genomics initiated and prosecuted, or maintained the defense of,
the
action, the amount of any recovery remaining then shall be retained
by US
Genomics; and
|
(iv) |
if
Rosetta Genomics initiated and prosecuted, or maintained the defense
of,
the action, the amount of any recovery remaining shall be retained
by
Rosetta Genomics, except that US Genomics shall receive a portion
equivalent to the royalties they would have received on such remaining
amount if such amount were deemed Net
Sales.
|
7.4. |
Patent
Term Extensions and Supplemental Protection Certificates.
The Parties shall cooperate in obtaining patent term extensions or
supplemental protection certificates or their equivalents in any
country
in the Territory where applicable and where desired by Rosetta Genomics.
If elections with respect to obtaining such extension or supplemental
protection certificates are to be made, Rosetta Genomics shall have
the
first right to make the election, in consultation with US
Genomics.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ARTICLE
VIII
TERM
AND TERMINATION
8.1. |
Term
and Expiration.
This Agreement shall be effective as of the Effective Date and, unless
terminated earlier pursuant to Section 8.2 or Section 8.3 below,
shall
continue in effect with respect to all US Genomics Patent Rights,
US
Genomics Know-How and any other rights licensed to Rosetta Genomics
hereunder, until the expiration of all payment obligations under
Section
5.1 hereof.
|
8.2. |
Termination
by Notice.
Notwithstanding anything contained herein to the contrary, Rosetta
Genomics shall have the right, in its reasonable business or scientific
judgment, to terminate this Agreement in its entirety at any time
by
giving ninety (90) days advance written notice to US Genomics. Except
as
expressly set forth in this Agreement (including, without limitation,
those rights and obligations respecting confidentiality and indemnity
hereunder), the rights and obligations hereunder of the Parties,
excluding
any payment obligation which has accrued prior to the termination
date or
that is required by Section 5.1(i), (ii), (iii) or (iv), shall terminate
(including Rosetta Genomics’ rights and obligations with respect to the US
Genomics Patent Rights and the US Genomics Know-How); in any event
of
termination by Rosetta Genomics according to this Section 8.2, US
Genomics
shall not be entitled to any compensation or any other payment whatsoever
except as set forth in Section 5.1(i), (ii), (iii) or (iv) and excluding
any obligation which has accrued prior to the termination date, which
shall be promptly paid by Rosetta
Genomics.
|
8.3. |
Termination
for Cause.
Either Party may terminate this Agreement by notice to the other
Party at
any time during the term of this Agreement as
follows:
|
(i) |
if
the other Party is in breach of its material obligations hereunder
(other
than a breach for failure to make payments covered in Section 8.3(ii))
below), which breach is not cured within ninety (90) days after the
date
of the notice from the non-defaulting Party specifying the breach
in
reasonable detail, provided, however, that if a curable breach is
not
capable of being cured within ninety (90) days of such written notice,
the
Agreement may not be terminated so long as the breaching Party commences
and is taking commercially reasonable actions to cure such breach
as
promptly as practicable. In any event, if a curable breach has not
been
cured within one-hundred eighty (180) days after notice requesting
cure,
then the non-breaching Party may terminate this Agreement effective
upon
expiration of such one-hundred eighty (180) day
period;
|
(ii) |
if
the defaulting Party fails to pay the other Party any amounts due
and
payable to such Party (together with any accrued interest at the
rate set
forth in this Agreement) and has not cured such breach within thirty
(30)
days after notice requesting cure of the breach, the Party entitled
to
receive payment shall have the right to (i) terminate this Agreement
immediately upon expiration of such thirty (30) day period and institute
an action to collect such overdue amounts and to pursue any other
rights
or remedies such Party may have at law or in equity or (ii) institute
an
action to collect such amounts without terminating this Agreement;
or
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(iii) |
upon
the filing or institution of bankruptcy, reorganization, liquidation
or
receivership proceedings, or upon an assignment of all or substantially
all of the assets for the benefit of creditors by the other Party;
provided,
however,
in the case of any involuntary bankruptcy, reorganization, liquidation,
receivership or assignment proceeding such right to terminate shall
only
become effective if the Party consents to the involuntary proceeding
or
such proceeding is not dismissed within ninety (90) days after the
filing
thereof.
|
8.4. |
Effect
of Expiration or Termination.
|
8.4.1 |
Expiration
or termination of this Agreement shall not relieve the Parties of
any
obligation accruing prior to such expiration or termination. In addition
to any other provisions of this Agreement which by their terms continue
after the expiration of this Agreement, the provisions of Article
IV and
Article X shall survive the expiration or termination of this Agreement.
In addition, any other provision required to interpret and enforce
the
Parties’ rights and obligations under this Agreement shall also survive,
but only to the extent required for the full observation and performance
of this Agreement. Any expiration or early termination of this Agreement
shall be without prejudice to the rights of any Party against the
other
Party accrued or accruing under this Agreement prior to termination,
including the obligation to pay royalties for Product(s) sold prior
to
such termination. Except as expressly set forth herein, the rights
to
terminate as set forth herein shall be in addition to all other rights
and
remedies available under this Agreement, at law, in equity, or
otherwise.
|
8.4.2 |
Except
as otherwise provided in this Section 8, in the event (a) of termination
of this Agreement by Rosetta Genomics in accordance with Section
8.2 or
(b) of termination of this Agreement by US Genomics in accordance
with
Section 8.3(i) or Section 8.3(ii), Rosetta Genomics shall have no
further
rights with respect to the US Genomics Patent Rights and the US Genomics
Know-How, and Rosetta Genomics shall promptly return any and all
US
Genomics Patent Rights and all US Genomics Know-How in its possession
at
the time of termination.
|
8.4.3 |
Rights
in Bankruptcy.
All rights and licenses granted under or pursuant to this Agreement
by US
Genomics are, and shall otherwise be deemed to be, for purposes of
Section
365(n) of the United States Bankruptcy Code, licenses of rights to
“intellectual property” as defined under Section 101 of the United States
Bankruptcy Code. The Parties agree that Rosetta Genomics, as licensee
of
such rights under this Agreement, shall retain and may fully exercise
all
of its rights and elections under the United States Bankruptcy Code.
The
Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against US Genomics under the United
States
Bankruptcy Code, Rosetta Genomics 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, which,
if not
already in Rosetta Genomics’ possession, shall be promptly delivered to it
(i) upon any such commencement of a bankruptcy proceeding upon Rosetta
Genomics’ written request therefor, unless US Genomics continues to
perform all of its obligations under this Agreement or (ii) if not
delivered under clause (i) above, following the rejection of this
Agreement by or on behalf of US Genomics upon written request therefor
by
Rosetta Genomics.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ARTICLE
IX
MANUFACTURING
AND SUPPLY
Following
the completion of Phase II of the Development Plan, US Genomics and Rosetta
Genomics shall negotiate a Supply Agreement providing for US Genomics to supply
US Genomics Platforms and either finished US Genomics Based Products or reagents
for US Genomics Based Products to Rosetta Genomics at a price equal to the
fully
loaded manufacturing cost thereof plus [***]% and for maintenance and service
of
US Genomics Platforms by US Genomics.
ARTICLE
X
INDEMNITY
10.1. |
General.
For purposes of this Article 10 “Indemnified Parties” refers to US
Genomics, its Affiliates and the officers, directors, employees and
agents
of US Genomics and its Affiliates when Rosetta Genomics is the indemnitor,
and “Indemnified Parties” refers to Rosetta Genomics, its Affiliates and
officers, directors, employees and agents of Rosetta Genomics and
its
Affiliates when US Genomics is the
indemnitor.
|
10.1.1 |
Rosetta
Genomics Indemnity.
Rosetta Genomics shall indemnify and hold harmless the US Genomics
Indemnified Parties and each of them from any and all losses, damages,
liabilities and costs (including reasonable attorneys’ fees and expenses)
(collectively, “Losses”) associated with any claim, complaint, suit,
proceeding or cause of action (collectively, “Claims”) against any US
Genomics Indemnified Party by a third party (i) alleging physical
or other
injury, including death, arising out of, based upon, or resulting
from the
research, development, testing, registration, storage, handling,
packaging, distribution, marketing, sale or use of any Product or
Service
by Rosetta Genomics, its Affiliates, Sublicensees or distributors,
or (ii)
arising out of any breach by Rosetta Genomics of any representation,
warranty or covenant hereunder, except in either case to the extent
such
Losses are determined to have resulted from the negligence or willful
misconduct of any US Genomics Indemnified
Party.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
10.1.2 |
US
Genomics Indemnity.
US Genomics shall indemnify and hold harmless the Rosetta Genomics
Indemnified Parties and each of them from any and all Losses, associated
with any Claim against any Rosetta Genomics Indemnified Party by
a third
party (i) alleging physical or other injury, including death arising
out
of, based upon, or resulting from the research, development, testing,
registration, manufacture, storage, handling, packaging, distribution,
marketing, sale or use of any Product or Service by US Genomics,
its
Affiliates, sublicensees or distributors (excluding Rosetta Genomics),
or
(ii) arising out of any breach by US Genomics of any representation,
warranty or covenant hereunder, except in either case to the extent
such
Losses are determined to have resulted from the negligence or willful
misconduct of any Rosetta Genomics Indemnified
Party.
|
10.2. |
Conditions
to Indemnification.
An Indemnified Party seeking recovery under this Article 10 in respect
of
a Claim shall give prompt notice of such Claim to the Party from
which
recovery is sought (the “Indemnifying Party”) and, provided that the
Indemnifying Party is not contesting its obligation under this Article
10,
shall permit the Indemnifying Party to control any litigation relating
to
such Claim and the disposition of such Claim; provided that the
Indemnifying Party shall (a) act reasonably and in good faith with
respect
to all matters relating to the settlement or disposition of such
Claim as
the settlement or disposition relates to Parties being indemnified
under
this Article 10, (b) not settle or otherwise resolve such Claim without
the prior written consent of the Indemnified Party (which consent
shall
not be unreasonably withheld, conditioned or delayed). The Indemnified
Party shall cooperate with the Indemnifying Party in its defense
of any
such Claim in all reasonable respects and shall have the right to
be
present in person or through counsel at all legal proceedings with
respect
to such Claim.
|
10.3. |
Survival.
Each Party acknowledges and hereby agrees that the obligations set
forth
in this Article X shall survive the termination or expiration of
this
Agreement until the later of (a) [***] ([***]) years from the date
of
expiration or termination, or (b) the expiration of all applicable
statutes of limitations.
|
10.4. |
Insurance.
Both Rosetta Genomics and US Genomics shall maintain, at their respective
expense, sufficient product liability insurance and other insurance
insuring against all liability, including product liability, personal
injury, physical injury and property damage in such amounts as are
reasonable and customary for companies of comparable size and activities
in the U.S. diagnostics industry and in relation to their respective
liability/risk exposures under this
Agreement.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ARTICLE
XI
MISCELLANEOUS
11.1. |
Force
Majeure.
Neither Party shall be held liable or responsible to the other Party
nor
be deemed to have defaulted under or breached this Agreement for
failure
or delay in fulfilling or performing any term of this Agreement during
the
period of time when such failure or delay is caused by or results
from
causes beyond the reasonable control of the affected Party including,
but
not limited to, fire, flood, embargo, war, acts of war (whether war
be
declared or not), insurrection, riot, civil commotion, strike, lockout
or
other labor disturbance, act of God or act, omission or delay in
acting by
any governmental authority or the other Party. The affected Party
shall
notify the other Party of such force majeure circumstances as soon
as
reasonably practicable and the affected Party shall use all reasonable
efforts to avoid or remove such causes of non-performance as promptly
as
practicable and shall promptly continue performance whenever such
causes
are removed. When such circumstances arise, the Parties shall discuss
what, if any, modification of the terms of this Agreement may be
required
in order to arrive at an equitable
solution.
|
11.2. |
Assignment.
This Agreement may not be assigned or otherwise transferred, nor,
except
as expressly provided hereunder, may any right or obligations hereunder
be
assigned or transferred by a Party without the prior written consent
of
the other Party; provided,
however,
that either Party may assign this Agreement and its rights and obligations
hereunder without the consent of the other Party hereto to an Affiliate
or
in connection with the transfer or sale of all or substantially all
of its
assets related to the Products or Services or its business or in
the event
of its merger or consolidation or change in control or similar
transaction. Except as otherwise set forth herein, any permitted
assignee
shall assume all obligations of its assignor under this Agreement
(without
releasing the assignor of its obligations hereunder). Any assignment
or
attempted assignment contrary to the provisions hereof shall be null
and
void.
|
11.3. |
Severability.
In the event that any of the provisions contained in this Agreement
are
held invalid, illegal or unenforceable in any respect, the validity,
legality and enforceability of the remaining provisions contained
herein
shall not in any way be affected or impaired thereby, unless the
absence
of the invalidated provision(s) adversely affect the substantive
rights of
the Parties. In such event, the Parties shall replace the invalid,
illegal
or unenforceable provision(s) with valid, legal and enforceable
provision(s) which, insofar as practicable, implement the purposes
of this
Agreement.
|
11.4. |
Notices.
All notices or other communications which are required or permitted
hereunder shall be in writing and sufficient if delivered personally,
sent
by facsimile (and promptly confirmed by personal delivery, registered
or
certified mail or overnight courier), sent by a nationally-recognized
overnight courier providing evidence of delivery or sent by registered
or
certified mail, postage prepaid, return receipt requested, addressed
as
follows:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
If
to
Rosetta Genomics to:
Rosetta
Genomics, Ltd.
00
Xxxxx
Xxxxxx
Xxxxxxx
Xxxx
Xxxxxxx,
Xxxxxx
Tel:
000-0-000-0000
Fax:
000-0-000-0000
Attention:
Chief Executive Officer
With
a
copy to the legal department and to:
Rosetta
Genomics, Inc.
000
XX
Xxxxxxx 0, xxxxx X000
Xxxxx
Xxxxxxxxx, XX 00000
Attention:
Chief Executive Officer
If
to US
Genomics to:
US
Genomics, Inc
00
Xxxx
Xxxxxx, xxxxx 0000
Xxxxxx,
XX 00000
Tel:
000
000 0000
Fax:
000
000 0000
Attention:
Chief Executive Officer
or
to
such other address as the Party to whom notice is to be given may have furnished
to the other Party in writing in accordance herewith. Any such communication
shall be deemed to have been given when delivered if personally delivered or
sent by facsimile on a Business Day, upon confirmed delivery by nationally
recognized overnight courier if so delivered and on the third Business Day
following the date of mailing if sent by registered or certified
mail.
11.5. |
Applicable
Law.
The Agreement shall be governed by and construed in accordance with
the
laws of the State of New York (USA) without reference to any rules
of
conflict of laws.
|
11.6. |
Dispute
Resolution.
In the event of any dispute arising between the Parties in connection
with
this Agreement, the construction thereof, or the rights, duties or
liabilities of either Party (each a “Disputed Matter”), the Disputed
Matter shall be submitted to the Chief Executive Officers of the
Parties
for good faith resolution. In the event the Disputed Matter cannot
be
resolved by the good faith efforts of the Chief Executive Officers
on or
before thirty (30) days from the date such Disputed Matter is first
presented for resolution, then such Disputed Matter shall be resolved
by
binding arbitration in accordance with the following
procedures:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(a) |
The
arbitration shall be conducted by a panel of three (3) persons experienced
in the diagnostics industry who are independent of both Parties.
Within
thirty (30) days after initiation of arbitration, each Party shall
select
one person to act as arbitrator and the two Party-selected arbitrators
shall select a third arbitrator within thirty (30) days of their
appointment. If the arbitrators selected by the Parties are unable
or fail
to agree upon the third arbitrator, the third arbitrator shall be
appointed by the American Arbitration Association (“AAA”). The place of
arbitration shall be New York, New York, and all proceedings and
communications shall be in English. Except as provided for differently
herein, the arbitration shall be conducted under the rules of the
AAA
applicable to complex business
disputes.
|
(b) |
Either
Party may apply to the arbitrators for interim injunctive relief
until the
arbitration decision is rendered or the Disputed Matter is otherwise
resolved. Either Party also may, without waiving any right or remedy
under
this Agreement, seek from any court having jurisdiction any injunctive
or
provisional relief necessary to protect the rights or property of
that
Party pending resolution of the Disputed Matter pursuant to this
Section
11.6. The arbitrators shall have no authority to award punitive or
any
other type of damages not measured by a Party’s compensatory damages. Each
Party shall bear its own costs and expenses and attorneys’ fees, and the
Party that does not prevail in the arbitration proceeding shall pay
the
arbitrators’ fees and any administrative fees of
arbitration.
|
(c) |
Except
to the extent necessary to confirm an award or decision or as may
be
required by applicable laws, neither a Party nor an arbitrator may
disclose the existence, content, or results of an arbitration without
the
prior written consent of both Parties. In no event shall an arbitration
be
initiated after the date when commencement of a legal or equitable
proceeding based on the Disputed Matter would be barred by the applicable
New York statute of limitations.
|
(d) |
The
Parties agree that, in the event of a Disputed Matter involving the
alleged breach of this Agreement, neither Party may terminate this
Agreement until resolution of the Disputed Matter pursuant to this
Section
11.6.
|
(e) |
The
Parties hereby agree that any disputed performance or suspended
performance pending the resolution of a Disputed Matter that the
arbitrators determine to be required to be performed by a Party must
be
completed within a reasonable time period following the final decision
of
the arbitrators.
|
(f) |
The
Parties hereby agree that any monetary payment to be made by a Party
pursuant to a decision of the arbitrators shall be made in United
Stales
Dollars, free of any tax or other deduction. The Parties further
agree
that the decision of the arbitrators shall be the sole, exclusive
and
binding remedy between them regarding determination of Disputed Matters
presented.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11.7. |
Entire
Agreement.
This Agreement, including all exhibits hereto, contains the entire
understanding of the Parties with respect to the subject matter hereof.
All express or implied agreements and understandings, either oral
or
written, heretofore made are expressly superseded by this Agreement.
This
Agreement may be amended, or any term hereof modified, only by a
written
instrument duly executed by all Parties
hereto.
|
11.8. |
Independent
Contractors.
It is expressly agreed that the Parties shall be independent contractors
and that the relationship between the Parties shall not constitute
a
partnership, joint venture or agency. Neither Party shall have the
authority to make any statements, representations or commitments
of any
kind, or to take any action which shall be binding on the other Party,
without the prior consent of such other Party. This Agreement shall
not
impose any obligation on either Party except as expressly set forth
herein.
|
11.9. |
Amendment;
Waiver.
This Agreement may be amended, modified, superseded or canceled,
and any
of the terms of this Agreement may be waived, only by a written instrument
executed by each Party or, in the case of waiver, by the Party or
Parties
waiving compliance. The delay or failure of any Party at any time
or times
to require performance of any provision shall in no manner affect
the
rights at a later time to enforce the same. The waiver by a Party
hereto
of any right hereunder or the failure to perform or of a breach by
another
Party shall not be deemed a waiver of any other right hereunder or
of any
other breach or failure by said other Party whether of a similar
nature or
otherwise.
|
11.10. |
Headings.
The captions to the several Articles and Sections hereof are not
a part of
the Agreement, but are merely guides or labels to assist in locating
and
reading the several Articles and Sections
hereof.
|
11.11. |
Counterparts.
The Agreement may be executed in two or more counterparts, each of
which
shall be deemed an original, but all of which together shall constitute
one and the same instrument.
|
11.12. |
Binding
Effect.
This Agreement shall be binding upon and inure to the benefit of
the
Parties and their respective legal representatives, successors and
permitted assigns.
|
11.13. |
No
Third Party Beneficiaries.
Except as set forth in Article 10, no Third Party (including, without
limitation, employees of either Party) shall have or acquire any
rights by
reason on this Agreement.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11.14. |
Further
Assurances.
Each of the Parties agrees to duly execute and deliver, or cause
to be
duly executed and delivered, such further instruments and do and
cause to
be done such further acts and things, including, without limitation,
the
filing of such additional assignments, agreements, documents and
instruments, as the other Party may at any time and from time to
time
reasonably request in connection with this Agreement or to carry
out more
effectively the provisions and purposes of, or to better assure and
confirm unto such other Party its rights and remedies under, this
Agreement.
|
THE
REST OF THIS PAGE WAS INTENTIONALLY LEFT BLANK
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the date first
set forth above.
ROSETTA
GENOMICS, LTD.
By:__________________________________
Name:
Title: President
US
GENOMICS, INC.
By:__________________________________
Name:
Title:
Chief Executive Officer
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
EXHIBIT
A
US
Genomics-Rosetta Genomics: Development Plan for Lung Cancer Early
Diagnostics
Goal:
|
Develop
a [***] for early detection of lung cancer,
[***]
|
Discovery
stage:
[***]
and [***] of [***]
Phase
Ia:
[***]
based on [***] (Rosetta)
1.
|
[***]
and [***]. At this stage the purpose is to[***] lung[***], so [***]
should
be [***] at [***] to get [***]
|
2.
|
[***]
from [***]
|
3.
|
[***]
|
4.
|
[***]
data to [***] a subset of [***] lung[***]These must be [***] lung
[***]
lung [***], based on at [***] will be given to[***] which are [***]
lung
[***] and are not [***] of [***] Rosetta will update USG as [***]
lung[***], this phase may be [***]
|
Phase
Ib
[***]
from [***] (Rosetta)
1.
|
[***]
for [***]
|
2.
|
[***]
for [***]
|
Phase
Ic
[***]
USG [***] to enable [***] of the [***] (USG)
1.
|
[***]
for USG [***]
|
2.
|
[***]
of the [***] for these [***]
|
3.
|
[***]of
suggested [***] lung [***] using USG
[***]
|
The
[***]
that will be [***] will be [***] after considering [***]
Phase
Id:
[***]
from USG to Rosetta including [***] for [***]
Phase
II:
[***]
lung[***]
1.
|
[***]
lung [***]. At this stage the purpose is to [***]should be [***]
to
approach the [***] should be [***] will be later
[***]
|
2.
|
[***]
from [***]
|
3.
|
[***]
using the USG [***] (USG [***] and the
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
4.
|
[***]
is expected to be[***]
|
Validation
Stage:
[***]
Phase
IIIa
[***]
Goal:
|
[***]
of the [***] in the [***]
|
1.
|
[***]
from at [***] of the [***] in the
[***]
|
2.
|
[***]
from [***]
|
3.
|
[***]
on the USG [***]
|
4.
|
[***]
at the [***]
|
Phase
IIIb
Goal:
|
[***]The
details of the [***] will be [***]but it is [***] that this will[***]
of
the USG [***] and the [***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
EXHIBIT
B
US
Genomics Patent Rights
USG
REF. NO.
|
SERIAL
NO.
|
FILING
DATE
|
INVENTORS
|
TITLE
|
STATUS
|
||
[***]
|
[***]
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[***]
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[***]
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|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
USG
REF. NO.
|
SERIAL
NO.
|
FILING
DATE
|
INVENTORS
|
TITLE
|
STATUS
|
||
[***]
|
[***]
|
[***]
|
[***]
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[***]
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|
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
EXHIBIT
C
Rosetta
Genomics Patent Rights
RG
ID
|
Country
|
App
No
|
Filed
|
Inventors
|
Title
|
Earliest
Priority App
|
Earliest
Priority Date
|
[***]
|
[***]
|
[***]
|
[***]
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[***]
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.