|
Contact
:
Media
Alan
Zachary
T:
1-(312)-944-6784
media@rosettagenomics.com
|
Investors
Juliane
Snowden
T:
1-(212)-213-0006
investors@rosettagenomics.com
|
Rosetta
Genomics Reports Second Quarter 2007 Financial Results
Two
Patents Issued and Diagnostic Oncology Pipeline Expanded
Rehovot,
Israel (August 2, 2007
)
-
Rosetta
Genomics, Ltd. (Nasdaq: ROSG), a global leader in the field of microRNA and
RNAi, reported today its consolidated financial results for the quarter and
six
months ended June 30, 2007, and business highlights.
For
the
quarter ended June 30, 2007, Rosetta recorded a net loss of $2.3 million, or
$0.19 per ordinary share, as compared to $1.8 million, or $0.71 per ordinary
share, in the second quarter of 2006. For the six months ended June 30, 2007,
Rosetta recorded a net loss of $4.3 million, or $0.41 per ordinary share, as
compared to $3.3 million, or $1.28 per ordinary share, in the six months ended
June 30, 2006.
“This
second quarter has seen the rapid advancement of our diagnostic pipeline with
the addition of several microRNA-based diagnostic programs, as well as the
achievement of significant milestones in our intellectual property portfolio
with two patents relating to a microRNA gene issued to Rosetta Genomics,” stated
Amir Avniel, Rosetta Genomics Chief Executive Officer. “The powerful biomarker
discovery engine we developed over the last year has allowed us to expand our
oncology diagnostic pipeline, and we now believe we will see three or more
of
our products launched in 2008. Our intellectual property estate continues to
grow, as we were issued
two
patents relating to a human and viral microRNA. We see these patent issuances
as
validation of our intellectual property position and believe more patents will
follow in the coming months.
In
addition, we’ve seen steady progress in our microRNA-based therapeutic
collaboration for liver cancer with Isis Pharmaceuticals, funded in part by
the
BIRD foundation. Together, we have identified several antisense compounds,
which
we believe can be used to develop the first microRNA-based therapy for
hepatocellular carcinoma.
We
plan
to
begin testing leads to several microRNAs in animal models by the end of this
year.
We are
all very pleased with our progress thus far this year and are confident
w
e
will
continue to build shareholder value with our programs throughout 2007, leading
to the launch of our first products in 2008.”
Cash,
Cash Equivalents, Short term Bank Deposit and Marketable
Securities
As
of
June 30, 2007, Rosetta had cash, cash equivalents, short term bank deposits
and
marketable securities of $34.2 million, compared to $10.8 million on December
31, 2006, and $15.5 million on June 30, 2006. The Company received approximately
$26 million in net proceeds from its initial public offering of 4,312,500
ordinary shares in March 2007 and net proceeds of $13.8 million from a private
placement early in 2006 and from the exercise of warrants in 2006.
Net
Loss
The
net
loss for the second quarter of 2007 was $2.3 million, or $0.19 per ordinary
share, as compared to $1.8 million, or $0.71 per ordinary share, in the second
quarter of 2006. Non-cash stock-based compensation charges for the second
quarter of 2007 were $282,000 compared to $151,000 in the second quarter of
2006. Net loss for the six months ended June 30, 2007 was $4.3 million, or
$0.41
per ordinary share, as compared to $3.3 million, or $1.28 per ordinary share,
in
the six months ended June 30, 2006. Non-cash stock-based compensation charges
for the six months ended June 30, 2007 were $487,000 compared to $243,000 in
the
six months ended June 30, 2006. The Company’s accumulated deficit during the
development stage totaled $25.1 million for the period from March 9, 2000
(date of inception) to June 30, 2007.
Research
and Development Expenses
Research
and development remained the Company’s largest expense and accounted for
6
3
%
and 56%
of its operating expenses in the quarters ended June 30, 2007 and 2006,
respectively, and 58% of its operating expenses in the six months ended June
30,
2007 and 2006. Research and development expenses were $1.7 million in the second
quarter of 2007, including $67,000 of non-cash stock-based compensation, as
compared to $1.1 million in the second quarter of 2006, which included $77,000
of non-cash stock-based compensation. Research and development expenses were
$2.9 million in the six months ended June 30, 2007, including $133,000 of
non-cash stock-based compensation, as compared to $2.0 million in the six months
ended June 30, 2006, which included $129,000 of non-cash stock-based
compensation. The increases for each of the quarter and six months ended June
30, 2007 as compared to the same periods in 2006 resulted primarily from an
increase in costs relating to: the advancement of Rosetta Genomics’ diagnostic
programs; salaries and related expenses for the hiring of additional research
and development personnel; costs relating to filing, prosecution and maintenance
of the Company’s intellectual property portfolio and costs associated with
license fees.
Business
Development Expenses
Business
development expenses were $412,000 in the second quarter of 2007, including
$91,000 of non-cash stock-based compensation, as compared to $447,000 in the
second quarter of 2006. Business development expenses were $787,000 in the
six
months ended June 30, 2007, including $122,000 of non-cash stock-based
compensation, as compared to $834,000 in the six months ended June 30, 2006.
General
and Administrative Expenses
General
and administrative expenses were $595,000 in the second quarter of 2007,
including $124,000 of non-cash stock-based compensation, as compared to $438,000
in the second quarter of 2006, which included $74,000 of non-cash stock-based
compensation. General and administrative expenses were $1.3 million in the
six
months ended June 30, 2007, including $232,000 of non-cash stock-based
compensation, as compared to $649,000 in the six months ended June 30, 2006,
which included $114,000 of non-cash stock-based compensation. The increase
for
the second quarter of 2007 and for the six months ended June 30, 2007 as
compared to the second quarter of 2006 and the six months ended June 30, 2006
resulted primarily from an increase in costs relating to Rosetta Genomics’
operation as a public company.
Financial
Income, Net
Net
financial income was $455,000 in the second quarter of 2007, as compared to
net
financial income of $203,000 in the second quarter of 2006. Net financial income
was $655,000 in the six months ended June 30, 2007, as compared to net financial
income of $236,000 in the six months ended June 30, 2006. Financial income
is
derived primarily from interest income on bank deposits and realized income
from
marketable securities and the increases from 2006 to 2007 are primarily due
to a
higher level of cash during such periods.
Recent
Highlights
Rosetta
Genomics reports the following scientific and corporate highlights.
Intellectual
Property
|
|
·
|
In
May 2007, the United States Patent and Trademark Office (USPTO) issued
U.S. Patent No. 7,217,807. This is the first microRNA composition
of
matter patent ever issued and relates to a microRNA gene found in
the
Human Immunodeficiency Virus (HIV).
|
|
|
·
|
In
July 2007, the United States Patent and Trademark Office (USPTO)
issued
U.S. Patent No. 7,250,496. This second composition of matter
patent
relates to a human microRNA.
|
|
|
·
|
In
June 2007, the Company in-licensed from Rockefeller University proprietary
microRNAs for therapeutic uses.
|
Diagnostic
Programs
|
|
·
|
Rosetta
Genomics continues to advance its lead diagnostic program for Cancer
of
Unknown Primary (CUP). The Company believes that by using a panel
of only
28 microRNAs, it can potentially identify the site of origin of 15
tumor
types, with greater than 90% accuracy.
|
|
|
·
|
Due
in part to the Company’s rapid research into and current development of a
CUP diagnostic, Rosetta Genomics now has a robust oncology diagnostic
pipeline including adenocarcinoma vs. squamous-cell carcinoma for
classification of lung cancer and a diagnostic to distinguish between
lung
adenocarcinoma cancer and mesothelioma. These two diagnostics are
expected
to be launched in 2008.
|
Therapeutic
Programs
|
|
·
|
In
collaboration with Isis Pharmaceuticals Inc., and funded in part
by the
Binational Industrial Research and Development Foundation (BIRD),
Rosetta
Genomics identified “hits” in the development of a microRNA-based,
antisense therapeutic for liver cancer. The companies have identified
several potential antisense compounds that inhibit specific microRNAs,
leading to a decrease in proliferation of liver cancer cell-lines.
The
companies expect to test several leads in animal models by the end
of
2007.
|
|
|
·
|
Rosetta
Genomics and Ben Gurion University have signed a collaboration agreement
for the development of microRNA-based therapeutic applications against
key
infectious diseases based on viral microRNAs discovered by the Company.
The novel microRNAs validated were identified in several key viruses
including the Epstein-Barr virus (EBV), and Herpes Simplex Viruses
(HSV).
The collaboration will include target validation of the viral-encoded
microRNAs for the potential development of microRNA-based anti-viral
therapeutics.
|
MicroRNA
Extraction and Quantification Protocols from Body Fluids
|
|
·
|
The
Company completed the development of proprietary protocols for the
extraction of microRNA from body fluids adding to its cutting-edge
microRNA platform technologies. Rosetta Genomics has developed protocols
for the extraction of microRNAs from serum, saliva, amniotic fluids,
sputum, and urine. The Company
|
intends
to utilize these protocols to develop non-invasive, early detection tests for
multiple diseases, including its current programs in oncology.
Collaborations
and Licensing
|
|
·
|
In
May 2007, the Company entered into a research agreement with Columbia
University, in which Columbia investigators shall perform clinical
validation studies of Rosetta Genomics' first diagnostic products
in
Columbia's Clinical Laboratory Improvement Amendments (CLIA) certified
laboratory. Rosetta Genomics believes Columbia will complete these
clinical validation studies by the first quarter of
2008.
|
|
|
·
|
In
April 2007, Rosetta signed an agreement with the Henry Ford Hospital
in
Detroit, Michigan, to provide the Company with samples for the clinical
validation of its Cancer of Unknown Primary (CUP) diagnostic test.
|
Publications:
|
|
·
|
Rosetta
Genomics collaborated with scientists from the Weizmann Institute
of
Science to study the role of microRNA in cancer suppression. The
findings,
published in the June issue of
Molecular
Cell
,
suggest there is potential for a specific, single microRNA (miR-34a)
to be
used as a drug candidate in cancer therapy to increase programmed
cell-death (apoptosis) in the context of the potent tumor suppressor
p53
pathway.
|
Conference
Call Information
Rosetta
Genomics will host a conference call at 8:30 a.m. ET today to discuss second
quarter activities and recent corporate developments. To access the live
conference call, U.S. and Canadian participants may dial 866-356-4441;
international participants may dial 617-597-5396. To access the 24-hour audio
replay, U.S. and Canadian participants may dial 888-286-8010; international
participants may dial 617-801-6888. The access code for the replay is 88373937.
The
replay will be available until August 9, 2007. This conference call also will
be
webcast live and archived on Rosetta Genomics’ website until August 16, 2007, at
www.rosettagenomics.com.
A
live
audio webcast of the call will also be available on the "Investors" section
of
the company's website,
www.RosettaGenomics.com
.
An
archived webcast will be available on the Company's website approximately two
hours after the event, and will be archived for 14 days thereafter.
About
RNAi and MicroRNAs
RNAi
(RNA
interference) is the means by which plants, animals, and humans regulate protein
expression and represents a potentially revolutionary approach to the
development of human diagnostics and therapeutics. RNAi was
discovered in 1998 and the the Nobel Prize was awarded to Drs. Andrew Fire
and
Craig Mello in October 2006. This condensed timeline attests to the broad and
rapid advancement of the understanding of this key biological process and to
statements within the scientific community. In fact, RNAi has been referred
to
as "a major scientific breakthrough that happens once every decade or so."
RNAi is the natural process of gene silencing that is mediated
intracellularly by microRNAs. By targeting microRNAs, Rosetta Genomics
believes there is significant potential to create a new class of therapeutics
that can both up and down-regulate disease causing proteins. Since microRNAs
are
naturally produced inhibitors of protein production, a synthetic molecule
designed to mimic the activity of a microRNA can potentially cause RNAi to
decrease protein production while a microRNA inhibitor may have the potential
to
prevent RNAi from silencing specific messenger RNA, thereby increasing protein
production. This up and down regulation of the RNAi process may prevent
disease-causing proteins from being produced in too high or too low a quantity.
Moreover, microRNAs that regulate disease causing proteins may be used as
biomarkers for the disease, potentially enabling the use of the RNAi process
to
develop early detection diagnostics.
About
Rosetta Genomics
Rosetta
Genomics (Nasdaq: ROSG) is a leader in the development of microRNA-based
diagnostics and therapeutics. Founded in 2000, the Company’s integrative
research platform combining bioinformatics and state-of-the-art laboratory
processes has led to the discovery of hundreds of biologically validated novel
human microRNAs. Building on its strong IP position and strategic alliances
with
leading biotechnology companies, Rosetta Genomics is working to develop a full
range of diagnostic and therapeutic products based on microRNAs. The Company’s
primary focus is in the development of microRNA-based products to diagnose
and
treat different forms of cancer and infectious diseases.
Forward-Looking
Statement Disclaimer
Various
statements in this release concerning Rosetta’s future expectations, plans and
prospects, including without limitation, statements relating to the role of
microRNAs in human physiology and disease, the potential of microRNAs in the
development of therapeutics and diagnostic products, our expectation that
additional patents will issue in the future, and the progress of our diagnostic
and therapeutic programs, including the expected launch of our CUP diagnostic
product and other cancer diagnostic products in 2008, constitute forward-looking
statements for the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995. Actual results may differ materially
from those indicated by these forward-looking statements as a result of various
important factors, including risks related to: Rosetta’s approach to discover
and develop novel diagnostics products, which is unproven and may never lead
to
marketable products; Rosetta’s ability to fund and the results of further
pre-clinical and clinical trials; Rosetta’s ability to obtain, maintain and
protect the intellectual property utilized by Rosetta’s products; Rosetta’s
ability to enforce its patents against infringers and to defend its patent
portfolio against challenges from third parties; Rosetta’s ability to obtain
additional funding to support its business activities; Rosetta’s dependence on
third parties for development, manufacture, marketing, sales, and distribution
of products; the successful development of Rosetta’s product candidates, all of
which are in early stages of development; Rosetta’s ability to obtain regulatory
approval for products; competition from others using technology similar to
Rosetta’s and others developing products for similar uses; Rosetta’s dependence
on collaborators; and Rosetta’s short operating history; as well as those risks
more fully discussed under “Key Information - Risk Factors” in Rosetta’s Annual
Report on Form 20-F for the year ended December 31, 2006 on file with the
Securities and Exchange Commission. In addition, any forward-looking statements
represent Rosetta’s views only as of today and should not be relied upon as
representing its views as of any subsequent date. Rosetta does not assume any
obligation to update any forward-looking statements unless required by
law.
|
ROSETTA
GENOMICS LTD. AND ITS SUBSIDIARY
(A
development stage company)
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
U.S.
dollars in thousands (except share and per share
data)
|
|
|
|
Six
Months Ended June 30,
|
|
Three
Months Ended June 30,
|
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
|
|
|
Unaudited
|
|
|
|
Unaudited
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Research
and development, net
|
|
$
|
2,864
|
|
$
|
2,029
|
|
$
|
1,703
|
|
$
|
1,143
|
|
|
Marketing
and business development
|
|
|
787
|
|
|
834
|
|
|
412
|
|
|
447
|
|
|
General
and administrative
|
|
|
1,275
|
|
|
649
|
|
|
595
|
|
|
438
|
|
|
Operating
loss
|
|
|
4,926
|
|
|
3,512
|
|
|
2,710
|
|
|
2,028
|
|
|
Financial
income, net
|
|
|
(655
|
)
|
|
(236
|
)
|
|
(455
|
)
|
|
(203
|
)
|
|
Net
loss
|
|
$
|
4,271
|
|
$
|
3,276
|
|
$
|
2,255
|
|
$
|
1,825
|
|
|
Basic
and diluted net loss per Ordinary share
|
|
$
|
0.41
|
|
$
|
1.28
|
|
$
|
0.19
|
|
$
|
0.71
|
|
|
Weighted
average number of Ordinary shares used to
compute
basic and diluted net loss per Ordinary share
|
|
|
10,374,298
|
|
|
2,549,941
|
|
|
11,857,447
|
|
|
2,551,127
|
|
|
CONSOLIDATED
BALANCE SHEETS
|
|
U.S.
dollars in thousands
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
2007
|
|
2006
|
|
|
ASSETS
|
|
Unaudited
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
5,419
|
|
$
|
5,228
|
|
|
Short-term
bank deposits
|
|
|
—
|
|
|
5,149
|
|
|
Marketable
securities
|
|
|
28,737
|
|
|
386
|
|
|
Other
accounts receivable and prepaid expenses
|
|
|
295
|
|
|
134
|
|
|
Deferred
issuance costs
|
|
|
—
|
|
|
1,787
|
|
|
Total
current assets
|
|
|
34,451
|
|
|
12,684
|
|
|
SEVERANCE
PAY FUND
|
|
|
99
|
|
|
98
|
|
|
PROPERTY
AND EQUIPMENT, NET
|
|
|
655
|
|
|
461
|
|
|
Total
assets
|
|
$
|
35,205
|
|
$
|
13,243
|
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Short-term
bank loan, current maturities of capital
lease
and of long-term loan
|
|
$
|
29
|
|
$
|
48
|
|
|
Trade
payables
|
|
|
378
|
|
|
745
|
|
|
Other
accounts payable and accruals
|
|
|
905
|
|
|
750
|
|
|
Total
current liabilities
|
|
|
1,312
|
|
|
1,543
|
|
|
LONG-TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Long-term
bank loan and capital lease
|
|
|
18
|
|
|
29
|
|
|
Deferred
revenue
|
|
|
228
|
|
|
228
|
|
|
Accrued
severance pay
|
|
|
291
|
|
|
344
|
|
|
Total
Long-term Liabilities
|
|
|
537
|
|
|
601
|
|
|
SHAREHOLDERS’
EQUITY:
|
|
|
|
|
|
|
|
|
Share
capital:
|
|
|
27
|
|
|
17
|
|
|
Additional
paid-in capital
|
|
|
58,436
|
|
|
31,958
|
|
|
Other
comprehensive income
|
|
|
19
|
|
|
3
|
|
|
Deferred
stock-based compensation
|
|
|
(24
|
)
|
|
(48
|
)
|
|
Deficit
accumulated during the development stage
|
|
|
(25,102
|
)
|
|
(20,831
|
)
|
|
Total
shareholders’ equity
|
|
|
33,356
|
|
|
11,099
|
|
|
Total
liabilities and shareholders’ equity
|
|
$
|
35,205
|
|
$
|
13,243
|
|
The
Rockefeller University
License
Agreement
This
Agreement (this "
Agreement
") is between The Rockefeller University, a
New York nonprofit corporation ("Rockefeller"), and Rosetta Genomics Ltd.,
an
Israeli corporation ("
Company
"). This Agreement will become effective
on
May
1,
2007
(the
"
Effective Date
").
BACKGROUND
Rockefeller
owns certain intellectual property developed by Dr. Thomas Tuschl relating
to
microRNA sequences. Rockefeller also owns certain applications for United States
letters patent relating to the intellectual property. Company desires to obtain
a non-exclusive license under the patent rights to exploit the intellectual
property. Rockefeller has determined that the exploitation of the intellectual
property by Company is in the best interest of Rockefeller and is consistent
with its educational and research missions and goal.
In
consideration of the mutual obligations contained in this Agreement, and
intending to be legally bound, the parties agree as follows:
1.
LICENSE
1.1
License Grant
. Rockefeller grants to Company and its Affiliates a
co-exclusive, as set forth in Section 1.3, world-wide license (the
"
License
") to make, have made, use, have used, import, sell, have sold,
and offer for sale Licensed Products in the Field of Use during the Term (as
such terms may be defined in Sections 1.2 and 6.1). Company may grant
sublicenses in connection with a bona fide collaboration with one or more third
parties established by written agreement, which (a) is for purposes of research
and/or development (which may include commercialization) of Licensed Products
under a jointly prepared research and/or development plan; and (b) includes
a
license or sublicense of Company's rights under its proprietary know-how or
patent rights relating to the Licensed Products, in addition to Rockefeller
Patent Rights. Rockefeller grants no other rights or licenses. For avoidance
of
doubt, Company will not have the right to grant sublicenses to the Rockefeller
Patent Rights solely.
1.2
Related
Definitions
.
The
term "
Affiliate
" means a legal entity that is controlling, controlled
by or under common control with Company and that has executed either this
Agreement or a written Joinder Agreement agreeing to be bound by all of the
terms and conditions of this Agreement. For purposes of this Section
1.2,
the
word
"
control
" means
(x)
the
direct or indirect ownership of more than fifty percent
(
50%
)
of
the
outstanding voting securities of a legal entity,
(y)
the
right
to receive fifty percent (50%) or more of the profits or earnings of a legal
entity, or
(z)
the
right
to determine the policy decisions of a legal entity.
The
term
"
Licensee
" means Company and its Affiliates.
The
term
"
Licensed Products
" means products that are made, made for, used,
imported, sold or offered for sale by Licensee and that either (i) in the
absence of this Agreement, would infringe
at
least
one
Valid Claim of the Rockefeller Patent Rights, (ii) use a process or machine
covered by a
Valid
Claim of Rockefeller Patent Rights, or (iii) use, at least in part, any
Rockefeller Technical Information covered by a Valid Claim of Rockefeller 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 24b-2 of the Securities Exchange
Act of 1934.
The
term
"Rockefeller
Patent
Rights
" means all patent rights represented
by
or
issuing from: (a) the United States patent applications listed in Exhibit
A;
(b)
any
continuation, divisional and reissue applications of (a); and (c) any foreign
counterparts and extensions of (a) or (b).
The
term
"
Rockefeller Technical Information
" means all the information contained
in the patents and the patent applications listed in Exhibit A and any other
technical information disclosed or referenced in Exhibit A.
The
term
"
Valid
Claim"
means
a
claim in a pending or
an
issued,
unexpired patent within the Rockefeller Patent Rights that (a) has not been
finally cancelled, withdrawn, abandoned
or
rejected
by
any
administrative agency or other body of competent jurisdiction, (b) has not
been
revoked, held invalid, or declared unpatentable or unenforceable in a decision
of a court or other body of competent jurisdiction that is unappealable or
unappealed within the time allowed for appeal,
(c)
has
not
been rendered unenforceable through disclaimer or otherwise, and (d) is not
lost
through an interference proceeding, provided however, that any claim that has
been pending for more than five (5) years after Company requests in writing
that
Rockefeller actively prosecute such claim (in the case of a claim to a specific
microRNA sequence by filing a divisional application specific to such sequence)
shall cease to be a Valid Claim unless and until such claim is issued.
The
term
"
Field of Use
" means human and animal therapeutics.
1.3
Reservation of Rights by Rockefeller
. Rockefeller reserves the
right to use, and to permit other entities to use, the Rockefeller Patent Rights
for all purposes, provided however, that Rockefeller will not grant more than
three (3) additional licenses to third parties to make, have made, use, have
used, import, sell, have sold or offer for sale and have offered for sale
Licensed Products in the Field of Use during the Term.
1.4
U.S.
Government Rights
. The parties acknowledge that the United
States government retains rights in intellectual property funded under any
grant
or similar contract with a Federal agency. The License is expressly subject
to
all applicable United States government rights, including, but not limited
to,
any applicable requirement that products, which result from such intellectual
property and are sold in the United States, must be substantially manufactured
in the United States. At the request of Company, and Company's expense,
Rockefeller will assist Company in an effort to obtain a waiver of such
requirement.
1.5
Sublicense Conditions
. Company's right to grant sublicenses under
the License shall be subject to the requirements of Section l.l(a) and (b).
Any
such sublicense will be subject to each of the following conditions:
(a)
In
each sublicense agreement, Licensee will (i) prohibit the sublicensee from
further sublicensing, except for a further sublicense limited to the right
to
manufacture and distribute a Licensed Product developed by the sublicensee,
and
(ii) require the sublicensee to comply with the terms and conditions of this
Agreement other than the payment and reporting obligations of Company.
(b)
Within thirty (30) days after Licensee enters into a sublicense agreement,
Company will deliver to Rockefeller a complete and accurate copy of the entire
sublicense agreement written in the English language. Rockefeller's receipt
of
the sublicense agreement, however, will constitute neither an approval of the
sublicense nor a waiver of any right of Rockefeller or obligation of Company
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 24b-2 of the Securities Exchange
Act of 1934.
(c)
In
the event that Company causes or experiences a bankruptcy event, all payments
due to Company from its Affiliates or sublicensees
under
the
sublicense agreement will, upon notice from Rockefeller to such Affiliate or
sublicensee, become payable directly to Rockefeller for the account of Company.
Upon receipt of any such funds, Rockefeller will remit to Company the amount
by
which such payments exceed the amounts owed by Company to Rockefeller.
(d)
Company's execution of a sublicense agreement will not relieve Company of any
of
its obligations under this Agreement. Company is primarily liable to Rockefeller
for any act or omission of an Affiliate or sublicensee of Company that would
be
a breach of this Agreement if performed or omitted by Company, and Company
will
be deemed to be in breach of this Agreement
as
a
result
of
such act or omission.
2.
DILIGENCE
2.1
Development Plan
. Company will deliver to Rockefeller, within [***]
days after the Effective Date, a copy of an initial development plan for the
Rockefeller Patent Rights (the "
Development
Plan
")
.
The purpose of the Development Plan is (a) to
demonstrate Company's
capability to bring the Rockefeller Patent Rights to commercialization, (b)
to
project the timeline for completing the necessary tasks, and (c) to measure
Company's progress against the projections. For the avoidance of doubt Company's
sole obligation to perform the various activities detailed in the Development
Plan, shall be to perform commercial reasonable efforts. Thereafter, Company
will deliver to Rockefeller an annual updated Development Plan no later than
each anniversary of the Effective Date. The Development Plan will include,
at a
minimum, the information listed in Exhibit B.
2.2
Company's
Efforts
.
Company
will use commercially reasonable efforts to develop, commercialize, market
and
sell Licensed Products in a manner consistent with the Development Plan.
3.
FEES AND ROYALTIES
3.1
License Initiation Fee
. In partial consideration of the License, Company
Rockefeller on the Effective Date a non-refundable, non-creditable license
initiation fee of $[***].
3.2
License
Maintenance Fees
.
In
partial consideration of the License, Company will pay to Rockefeller, on each
anniversary of the Effective Date until the first commercial Sale of the first
Licensed Product, a license maintenance fee of $[***].
3.3
Milestone
Payments
.
In
partial consideration of the License, Company will pay to Rockefeller the
applicable milestone payment listed in the table below after achievement of
each
milestone event for each Licensed Product, whether by Company or its
Affiliates.
|
MILESTONE
|
|
PAYMENT
|
|
|
[***]
|
|
$
|
[***]
|
|
|
[***]
|
|
$
|
[***]
|
|
|
[***]
|
|
$
|
[***]
|
|
|
[***]
|
|
$
|
[***]
|
|
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 24b-2 of the Securities Exchange
Act of 1934.
3.4
Progress
Report
.
In
addition, Company shall provide Rockefeller on each anniversary of the Effective
Date with written progress reports discussing the development, evaluation,
testing and commercialization of all Licensed Products.
3.5
Earned Royalties
. In partial consideration of the License, Company will
pay to Rockefeller a royalty of [***] percent ([***] %) of Net Sales during
the
Quarter.
The
term
"
Quarter
" means each three-month period beginning on January 1, April
1, July 1 and October 1.
The
term
"
Net
Sales
"
means
the consideration received from, or fair market value attributable
to,
each
Sale, less Qualifying Costs directly attributable to a Sale and actually
identified on the
invoice
and borne by Licensee. Net Sales shall not include sales
or
transfers
between Company and its Affiliates, unless the Licensed Product is consumed
by
the Affiliate. For purposes of determining Net Sales, the words "fair market
value" mean the cash consideration that Licensee would realize from an unrelated
buyer in an arms length sale of an identical item sold in the same quantity
and
at the time and place of the transaction.
The
term
"
Sale
"
means
any bona fide transaction by Licensee with
an
unaffiliated
third party for which consideration is received or expected for the sale, use,
lease, transfer or other disposition of a Licensed Product, and
a
Sale
is
deemed completed at the time that Licensee invoices, ships or receives payment
for
a
Licensed
Product, whichever occurs first.
The
term
"
Qualifying Costs
" means: (a) customary discounts in the trade for
quantity purchased, prompt payment or wholesalers and distributors; (b) credits
or refunds for claims or returns that do not exceed the original invoice amount;
and (c) prepaid outbound transportation expenses and transportation insurance
premiums. In no case will the Qualifying Costs exceed [***] ([***]%) of the
gross proceeds, or fair market value, attributable to Sales.
3.6
Sublicense
Fees
.
In
partial consideration of the License, Company will pay to Rockefeller a
sublicense fee of the applicable percentage listed in the table below of any
Sublicense Consideration received by Company from all sublicensees signed during
each of the development stages listed below.
|
[***]
|
|
|
[***]
|
%
|
|
[***]
|
|
|
[***]
|
%
|
|
[***]
|
|
|
[***]
|
%
|
"
Sublicense
Consideration
" means any consideration, whether in cash (e.g. initial or
upfront payments, technology access fees, annual fixed payments) or in kind
(e.g. devices, services, use rights, equity), received by Company and its
Affiliates from Sublicensees as consideration for the sublicense. Sublicense
Consideration specifically excludes (i) payments specifically committed to
compensate Company for the fully-burdened cost of future research and
development, (ii) running royalties, (iii) milestone payments in excess of
those
owed in Section 3.3, (iv) reimbursement of patent costs, (v) payments made
by
the Sublicensee in consideration of equity (shares, options, warrants or any
other kind of securities) of Company at fair market value, and (vi) equity
(shares, options, warrants or any other kind of securities) of the Sublicensee
purchased by Company at fair market value.
In
the
event that Company grants a sublicense that includes, in addition to the
Rockefeller Patent Rights, patents or patent applications controlled or licensed
by Company, the percentage of the Sublicense Consideration due to Rockefeller
will be based on the value reasonably attributable to the Rockefeller Patent
Rights relative to the value of the patents or patent applications controlled
or
licensed by Company included in such sublicense (such relative value of the
Rockefeller Patent Rights hereinafter the
"
Patent
Rights
Value
").
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 24b-2 of the Securities Exchange
Act of 1934.
After
any
sublicense agreement is executed, Company will suggest to Rockefeller the Patent
Rights Value based on a good faith fair market value determination of all
sublicensed technologies, together with any information reasonably necessary
or
useful for Rockefeller to evaluate such suggestion. If, within 30 days after
receipt of the information, Rockefeller objects for cause to the suggested
Patent Rights Value, Rockefeller will have the right to provide Company with
a
counter determination
of
the
Patent
Rights Value, which shall include any information necessary or useful to support
such counter-determination. If the Parties are unable to agree on a Patent
Rights Value determination within 30 days after receipt of such
counter-determination, one party may give notice to the other that the
disagreement should be referred to dispute resolution
3.7
Most Favored Licensee
. If Rockefeller grants a license under the
Rockefeller Patent Rights which will permit such licensee to manufacture or
sell
for any use within the scope of the license granted in this Agreement at a
lower
royalty rate than that provided in this Agreement, then Rockefeller will
promptly notify Company of such license. The notice will include all material
terms of such license, including degree of non-exclusivity, duration, field,
territory, audit rights, all fees, and royalty rates, and extend to Company
the
lower royalty rates along with all of the material terms and conditions of
such
license. In the event that Company elects to take the royalty rates and the
material terms and conditions of such noticed license, the royalty rate and
all
material terms and conditions of such noticed license shall apply to Company
upon the date Company provides Rockefeller with its written notice of such
election.
4
REPORTS
AND PAYMENTS
4.1
Royalty
Reports
.
Within
forty-five (45) days after the end of each Quarter following first commercial
Sale of a Licensed Product, Company will deliver to Rockefeller a report,
certified
by
the
chief
financial officer of Company, detailing the calculation of all royalties and
fees due to Rockefeller for such Quarter. The report will include, at a minimum:
(a) the number of Licensed Products involved in Sales, listed by product, by
country; (b) gross consideration invoiced, billed or received for Sales in
the
Quarter; (c) Qualifying Costs, listed by category of cost; (d) Net Sales, listed
by product, by country; (e) royalties and fees owed to Rockefeller, listed
by
category, by product, by country; and (g) any applicable credits resulting
from
royalty credits.
4.2
Payments
.
Company
will pay all royalties and fees due to Rockefeller under Sections 3.2, 3.3,
and
3.5 within [***] days after the end of the Quarter in which the royalties or
fees accrue. All applicable taxes and other charges such as duties, customs,
tariffs, imposts, and government imposed surcharges shall be borne by Company
and will not
be
deducted
from payments due Rockefeller.
4.3
Records
.
Company
will maintain, and will cause its Affiliates to maintain, complete and accurate
books and records to verify Sales, Net Sales, and all of the royalties, fees,
and other payments payable under this Agreement. The records for each Quarter
will be maintained for at least five (5) years after submission of the
applicable report required under Section 4.1.
4.4
Audit Rights
. Upon reasonable prior written notice to Company, Company
and its Affiliates will provide Rockefeller and its accountants with access
to
all of the books and records required by Section 4.3 to conduct a review or
audit of Sales, Net Sales, Qualifying Costs *including the method of determining
Qualifying Costs) and all of the royalties, fees, and other payments payable
under this Agreement. Access will be made available: (a) during normal business
hours; (b) in a manner reasonably designed to facilitate Rockefeller's review
or
audit without unreasonable disruption to Company's business; and (c) no more
than once each calendar year during the Term and for a period of five (5) years
thereafter. Company will promptly pay to Rockefeller the amount of any
underpayment determined by the review or audit plus accrued interest. If the
review or audit determines that Company has underpaid any royalty payment by
[***] percent ([***]%) or more, then or more, then Company will also promptly
pay the costs and expenses of Rockefeller and its accountants in connection
with
the review or audit.
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 24b-2 of the Securities Exchange
Act of 1934.
4.5
Currency
. All dollar amounts referred to in this Agreement are expressed
in United States dollars. All
payments will be made in
United States dollars. If Licensee receives payment from a third party in a
currency other than United States dollars for which a royalty or fee is owed
under this Agreement, then (a) the payment will be converted into United States
dollars at the conversion rate for the foreign currency as published in the
eastern edition of the Wall Street Journal as of the last business day of the
Quarter in which the payment was received by Licensee, and (b) the conversion
computation will be documented by Licensee in the applicable report delivered
to
Rockefeller under Section 4.1.
4.6
Place of Payment
. All payments by Company are payable to "The Rockefeller
University" and will be made to the following addresses:
|
By
Electronic Transfer:
|
|
By
Check:
|
|
|
|
|
|
JP
Morgan Chase Bank
|
|
The
Rockefeller University
|
|
1166
Avenue of the Americas, 16
th
Floor
|
|
Office
of Technology Transfer
|
|
New
York, NY 10036
|
|
502
Founders Hall
|
|
Swift
code: [***]
|
|
1230
York Avenue
|
|
Account
#: [***]
|
|
New
York, NY 10021
|
|
Routing
#: [***]
|
|
|
|
Account
Name: [***]
|
|
|
|
Reference:
[***]
|
|
|
4.7
Interest
. All amounts that are not paid by Company when due will accrue
interest from the date due until paid at a rate equal to [***] percent ([***]%)
per month (or the maximum allowed by law, if less).
5
CONFIDENTIALITY
AND
USE
OF ROCKEFELLER'S
NAME
5.1
Rockefeller's Confidential Information
. The term
"
Confidential
Information
" includes all
technical information, inventions, developments, discoveries, software,
know-how, methods, techniques, formulae, data, processes, and other proprietary
ideas, whether or not patentable, that Rockefeller identifies as confidential
or
proprietary at the time it is delivered or communicated to
Licensee.
5.2
Company's
Obligation
. Licensee will maintain in confidence and not disclose to any
third party any Confidential Information. Licensee will use the Confidential
Information only for the purposes of this Agreement. Company will ensure that
Licensee's employees have access to
Confidential
Information only on a need to know basis and are obligated in writing to abide
by Licensee's obligations under this Agreement. The obligations under this
Section 5.2 will not apply to: (a) information that is known to Licensee or
independently developed by Licensee prior to the time of disclosure, in each
case, where the Confidential Information is a specific microRNA sequence, to
the
extent evidenced by written records promptly disclosed to Rockefeller upon
receipt of the Confidential Information; (b) information that is disclosed
to
Licensee by a third party that has the right to make such disclosure; (c)
information that becomes patented, published or otherwise part of the public
domain as a result of acts by Rockefeller or a third party obtaining such
information as a matter of right; or (d) information that is required to be
disclosed by order of United States governmental authority or a court of
competent jurisdiction, provided that Licensee must use its best efforts to
obtain confidential treatment of such information by such agency or
court.
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 24b-2 of the Securities Exchange
Act of 1934.
5.3
Disclaimer
.
Rockefeller is not obligated to accept any confidential information from
Licensee, except for the reports required by Sections 2.1, 4.1 and 6.6.
Rockefeller, acting through its Office of Technology Transfer and finance
offices, will use its best efforts not to disclose to any third party outside
of
Rockefeller any confidential information of Licensee contained in those reports,
subject to exceptions analogous to those contained in Section 5.2(a) -
(d)
above.
Rockefeller bears no institutional responsibility for maintaining the
confidentiality of any other information of Licensee. Licensee may elect to
enter into confidentiality agreements with individual investigators at
Rockefeller that comply with Rockefeller's internal policies.
5.4
Use
of
Rockefeller's Name
.
Licensee, its employees, and its agents may not use the name, logo, seal,
trademark, or service mark (including any adaptation of them) of Rockefeller
or
any Rockefeller school, organization, employee, student or representative,
without the prior written consent of Rockefeller, unless it is required to
do so
by order of United States governmental authority or a court of competent
jurisdiction.
6
TERM AND TERMINATION
6.1
Term
.
This
Agreement will commence on Effective Date and terminate upon the later of:
(a)
the expiration or abandonment of the last patent to expire or become abandoned
of the Rockefeller Patent Rights; or (b) if no patent ever issues from the
Rockefeller Patent Rights, ten (10) years after the first commercial sale of
the
first Licensed Product (as the case may be, the
"Term"
)
.
6.2
Early
Termination by Company
.
Company
may terminate this Agreement at any time upon sixty (60) days prior written
notice to Rockefeller after completing each of the following: (a) ceasing to
make, have made, use, import, sell and offer for sale all Licensed Products;
(b)
causing all Affiliates to cease making, having made, using, importing, selling
and offering for sale all Licensed Products; and (c) paying all amounts owed
to
Rockefeller under this Agreement through the date of termination.
6.3
Early
Termination by Rockefeller
.
Rockefeller may terminate this Agreement if: (a) Company is more than sixty
(60)
days late in paying to Rockefeller any amounts owed under this Agreement and
does not immediately pay Rockefeller in full upon demand; or (b) Company or
its
Affiliates breaches this Agreement and does not cure the breach within forty
five (45) days after written notice of the breach.
6.4
Effect
of Termination
.
Upon
the termination of this Agreement for any reason: (a) the License terminates;
(b) Licensee will cease all making, having made, using, importing, selling
and
offering for sale all Licensed Products, except to extent permitted by Section
6.6; (c) Company will pay to Rockefeller all amounts owed to Rockefeller through
the date of termination under this Agreement; (d) Company will, at Rockefeller's
request, return to Rockefeller all Confidential Information; and (e) in the
case
of termination under Section 6.3, all duties of Rockefeller and all rights
(but
not duties) of Licensee under this Agreement immediately terminate without
further action required by either Rockefeller or Licensee.
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 24b-2 of the Securities Exchange
Act of 1934.
6.5
Inventory
and Sell Off
.
Upon
the termination of this Agreement for any reason, Company will cause physical
inventories to be taken immediately of: (a) all completed Licensed Products
on
hand under the control of Company or its Affiliates; and (b) such Licensed
Products as are in the process of manufacture and any component parts on the
date of termination of this Agreement. Company will deliver promptly to
Rockefeller a copy of the written inventory, certified by an officer of the
Company. Rockefeller will have forty-five (45) days after receipt of the report
to challenge the report and request an audit under Section 4.4. Upon termination
of this Agreement for any reason, Company will promptly remove, efface or
destroy all references to Rockefeller from any advertising or other materials
used in the promotion of the business of Company or its Affiliates, and Company
and its Affiliates will not represent in any manner that it has rights in or
to
the Rockefeller Patent Rights or the Licensed Products. Upon the termination
of
this Agreement for any reason other than pursuant to Section 6.3(a) or (c),
Company may sell off its inventory of Licensed Products existing on the
termination date for a period of six (6) months and pay Rockefeller royalties
on
Sales of such inventory within thirty (30) days following the expiration of
such
six (6) month period.
6.6
Survival
.
Company's obligation to pay all amounts owed to Rockefeller under this Agreement
will survive the termination of this Agreement for any reason. Articles 4,
5, 6,
8, 9 and 10 and Section 12.10 will survive the termination of this Agreement
for
any reason in accordance with their respective terms.
7
PATENT
MAINTENANCE AND REIMBURSEMENT
7.1
Patent
Maintenance
.
Rockefeller controls the preparation, prosecution and maintenance of the
Rockefeller Patent Rights and the selection of patent counsel, with input from
Company. Company will be copied on, and allowed to comment upon, all substantive
issues in the patent prosecution.
7.2
Patent
Reimbursement
.
Within
thirty (30) days after the Effective Date, Company will reimburse Rockefeller
$[***] for a pro rata share of patent and licensing costs incurred prior to
the
Effective Date. Company shall pay a pro rata share (based on the number of
licenses granted to the Rockefeller Patent Rights), not to exceed [***]%, for
all attorney fees, expenses, official fees and other charges incident to the
preparation, prosecution, and maintenance of such patent applications and
patents following the Effective Date.
8
INFRINGEMENT
8.1
Notice
.
Company
and Rockefeller will notify each other promptly of any infringement of the
Rockefeller Patent Rights that may come to their attention. Company and
Rockefeller will consult each other in a timely manner concerning any
appropriate response to the infringement.
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 24b-2 of the Securities Exchange
Act of 1934.
8.2
Prosecution
.
Rockefeller may prosecute any infringement of the Rockefeller Patent Rights
at
Rockefeller's expense. If Rockefeller elects to prosecute such infringement,
then financial recoveries will be retained by Rockefeller in their
entirety.
8.3
Intervention
.
Rockefeller reserves the right to request Company to join in any litigation
under Section 8.2. If Company elects to participate in any such litigation,
then
financial recoveries from any such litigation will be shared between Company
and
Rockefeller in proportion with their respective shares of the aggregate
litigation expenditures by Company and Rockefeller.
8.4
Company
Prosecution
.
If
Rockefeller does not prosecute any infringement of the Rockefeller Patent
Rights, then Company may prosecute such infringement at Company's expense.
Company must not settle or compromise any such litigation in a manner that
imposes any obligations or restrictions on Rockefeller or grants any rights
to
the Rockefeller Patent Rights without Rockefeller's prior written permission.
Financial recoveries from any such litigation will be: (a) first, applied to
reimburse Company for its litigation expenditures; and (b) second, as to any
remainder, retained by Company, but treated as Net Sales for the purpose of
determining the payment due to Rockefeller under Section 3.4.
8.5
Cooperation
.
In any
litigation under this Article 8, either party, at the request and expense of
the
other party, will cooperate to the fullest extent reasonably possible. This
Section 8.5 will not be construed to require either party to undertake any
activities, including legal discovery, at the request of any third party, except
as may be required by lawful process of a court of competent
jurisdiction.
9
REPRESENTATIONS, DISCLAIMER OF WARRANTIES; LIMITATION OF
LIABILITIES
9.1
Rockefeller and Company each represent that, to the best of their knowledge
as
of the Effective Date, they have the legal right and authority to enter into
this Agreement and to perform all obligations hereunder. Rockefeller further
represents that, to the best of the knowledge of the Office of Technology
Transfer as of the Effective Date, the patent applications listed on Exhibit
A
have been assigned to Rockefeller by the inventors named therein and Rockefeller
owns all right, title, and interest of such inventors in such patent
applications.
9.2
THE
ROCKEFELLER PATENT RIGHTS, ROCKEFELLER TECHNICAL INFORMATION, LICENSED PRODUCTS,
AND ANY OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT ARE PROVIDED ON AN “AS
IS” BASIS. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, ROCKEFELLER MAKES NO
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED
TO
ANY WARRANTY OF ACCURACY, COMPLETENESS, PERFORMANCE, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, COMMERCIAL UTILITY, NON-INFRINGEMENT OR TITLE.
ROCKEFELLER WILL NOT BE LIABLE TO LICENSEE, ITS SUCCESORS OR ASSIGNS, OR ANY
THIRD PARTY WITH RESPECT TO ANY CLAIM: ARISING FROM LICENSEE’S USE OF THE
ROCKEFELLER PATENT RIGHTS, ROCKEFELLER TECHNICAL INFORMATION, LICENSED PRODUCTS
OR ANY OTHER TECHNOLOGY LICENSED UNDER THIS AGREEMENT; ARISING FROM THE
DEVELOPMENT, TESTING, MANUFACTURE, USE OR SALE OF LICENSED PRODUCTS; OR FOR
LOST
PROFITS, BUSINESS INTERRUPTION, OR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES
OF
ANY KIND.
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 24b-2 of the Securities Exchange
Act of 1934.
10
INDEMNIFICATION
10.1
Indemnification
.
Company
will defend, indemnify, and hold harmless Rockefeller, and its trustees,
officers, faculty, agents, employees and students (each, an
"
Indemnified
Party
")
from
and against any and all liability, loss, damage, action, claim, or expense
suffered or incurred by the Indemnified Parties, including attorneys' fees
and
expenses (collectively, "
Liabilities
”),
arising out of or resulting from: (a) the development, testing, use,
manufacture, promotion, sale or other disposition of any Rockefeller Patent
Rights or Licensed Products by Licensee, vendors or third parties; (b) any
material breach of this Agreement by Licensee; and (c) the enforcement of this
Article 10 by any Indemnified Party. Liabilities include, but are not limited
to: (x) any product liability or other claim of any kind related to use by
a
third party of a Licensed Product that was manufactured, sold or otherwise
disposed of by Licensee, or vendors or third parties; (y) a claim by a third
party that the Rockefeller Patent Rights or the design, composition,
manufacture, use, sale or other disposition of any Licensed Product infringes
or
violates any patent, copyright, trade secret, trademark or other intellectual
property right of such third party; and (z) clinical trials or studies conducted
by or on behalf of Licensee, assignees or vendors or third parties relating
to
the Rockefeller Patent Rights or the Licensed Products, such as claims by or
on
behalf of a human subject of any such trial or study.
10.2
An
Indemnified Party entitled to be indemnified pursuant to 10.1 shall promptly
notify the Company in writing, of any claim or demand with reasonable
specificity, which the Indemnified Party has determined has given or is
reasonably likely to give rise to a right of indemnification under this
Agreement within 45 days of such determination; provided, however, that a
failure to provide such notice shall not relieve Company of its obligations
hereunder except to the extent that it has been materially prejudiced by such
failure. If the Indemnified Party shall notify Company of any claim or demand
pursuant to this Section 10.2, and if such claim or demand relates to a claim
or
demand asserted by a third party against the Indemnified Party that Company
acknowledges is a claim or demand for which it must indemnify or hold harmless
the Indemnified Party, the Company shall have the right to employ counsel of
its
choice to defend any such claim or demand asserted against the Indemnified
Party
provided that Company provides the Indemnified Party with a copy of the claim,
answer to the claim, periodic updates (including papers filed or served) as
requested by the Indemnified Party, an opportunity to review documents to be
served and/or to be filed on behalf of the Indemnified Party with adequate
time
to allow the Indemnified Party sufficient opportunity for review and comment
before such documents are served and/or field and the final papers resolving
the
matter. The Indemnified Party shall have the right to employ counsel of its
choice in the defense of any such claim or demand at its own expense. Company
shall notify the Indemnified Party in writing, as promptly as possible (but
in
any case ten (10) business days before the due date for the answer or response
to a claim) after the date of the notice of claim given by the Indemnified
party
to Company under this Section 10.2, of its election to defend in good faith
any
such third party claim or demand. So long as Company is defending in good faith
any such claim or demand asserted by a third party against the Indemnified
Party, the Indemnified Party shall not settle or compromised such claim or
demand without Company's approval. The Indemnified Party shall make available
to
Company or its agents, at Company's cost, all relevant records and other
material in the Indemnified Party's possession relating to any third party
claim
or demand.
10.3
Other
Provisions
.
Company
will not settle or compromise any claim or action giving rise to Liabilities
in
any manner that imposes any restrictions on obligations on Rockefeller or grants
any rights to the Rockefeller Patent Rights or the Licensed Products without
Rockefeller's prior written consent. If Company fails or declines to assume
the
defense of any claim or action within thirty (30) days after notice of the
claim
or action, then Rockefeller may assume the defense of such claim or action
for
the account and at the risk of Company, and any Liabilities related to such
claim or action will be conclusively deemed a liability of Company. The
indemnification rights of the Indemnified Parties under this Article 10 are
in
addition to all other rights that an Indemnified Party may have at law, in
equity or otherwise.
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 24b-2 of the Securities Exchange
Act of 1934.
11
INSURANCE
11.1
Coverages
.
Company
will procure and maintain insurance policies for the following coverages with
respect to personal injury, bodily injury and property damage arising out of
Company's performance under this Agreement: (a) during the Term, comprehensive
general liability, including broad form and contractual liability, in a minimum
amount of $[***] combined single limit per occurrence and in the aggregate;
(b)
prior to the commencement of clinical trials involving Licensed Products,
clinical trials coverage in a minimum amount of $[***] combined single limit
per
occurrence and in the aggregate; and (c) prior to the sale of the first Licensed
Product, product liability coverage, in a minimum amount of $[***] combined
single limit per occurrence and in the aggregate. Rockefeller may review
periodically the adequacy of the minimum amounts of insurance for each coverage
required by this Section 11.1, and Rockefeller reserves the right to require
Company to adjust the limits accordingly. The required minimum amounts of
insurance do not constitute a limitation on Company's liability or
indemnification obligations to Rockefeller under this Agreement.
11.2
Other
Requirements
.
The
policies of insurance required by Section 11.1 will be issued by an insurance
carrier with an A.M. Best rating of "A" or better and will name Rockefeller
as
an additional insured with respect to Company's performance under this
Agreement. Company will provide Rockefeller with insurance certificates
evidencing the required coverage within thirty (30) days after the commencement
of each policy period and any renewal periods. Each certificate will provide
that the insurance carrier will notify Rockefeller in writing at least thirty
(30) days prior to the cancellation or material change in coverage.
12
ADDITIONAL PROVISIONS
12.1
Independent
Contractors
.
The
parties are independent contractors. Nothing contained in this Agreement is
intended to create an agency, partnership or joint venture between the parties.
At no time will either party make commitments or incur any charges or expenses
for or on behalf of the other party.
12.2
No
Discrimination
.
Neither
Rockefeller nor Licensee will discriminate against any employee or applicant
for
employment because of race, color, sex, sexual or affectional preference, age,
religion, national or ethnic origin, handicap, or veteran status.
12.3
Compliance
with Laws
.
Licensee must comply with all prevailing laws, rules and regulations that apply
to its activities or obligations under this Agreement. For example, Licensee
will comply with applicable United States export laws and regulations. The
transfer of certain technical data and commodities may require a license from
the applicable agency of the United States government and/or written assurances
by Licensee that Licensee will not export data or commodities to certain foreign
countries without prior approval of the agency. Rockefeller does not represent
that no license is required, or that, if required, the license will
issue.
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 24b-2 of the Securities Exchange
Act of 1934.
12.4
Modification,
Waiver and Remedies
.
This
Agreement may only be modified by a written amendment that is executed by an
authorized representative of each party. Any waiver must be express and in
writing. No waiver by either party of a breach by the other party will
constitute a waiver of any different or succeeding breach. Unless otherwise
specified, all remedies are cumulative.
12.5
Assignment
.
Company
may not assign this Agreement or any part of it, either directly or by merger
or
operation of law, without the prior written consent of Rockefeller. Except
that
Company may assign this Agreement and the rights, obligations and interests
of
the Company, in whole, to any of its Affiliates, to any purchaser of all of
its
capital stock or assets or to any successor corporation resulting from any
merger or consolidation of Company with or into such corporation; each of which
will agree in writing to be legally bound by this Agreement. Rockefeller will
not unreasonably withhold or delay its consent, provided that: (a) at least
thirty (30) days before the proposed transaction, Company gives Rockefeller
written notice and such background information as may be reasonably necessary
to
enable Rockefeller to give an informed consent; (b) the assignee agrees in
writing to be legally bound by this Agreement; and (c) the assignee agrees
to
deliver to Rockefeller an updated Development Plan within forty-five (45) days
after the closing of the proposed transaction. Any permitted assignment will
not
relieve Company of responsibility for performance of any obligation of Company
that has accrued at the time of the assignment. Any prohibited assignment will
be null and void.
12.6
Notices
.
Any
notice or other required communication (each, a "
Notice
")
must
be in writing, addressed to the party's respective Notice Address listed on
the
signature page, and delivered: (a) personally; (b) by certified mail, postage
prepaid, return receipt requested; (c)
by
recognized overnight courier service, charges prepaid; or (d) by facsimile.
A
Notice will be deemed received: if delivered personally, on the date of
delivery; if mailed, five (5)
days
after deposit in the United States mail; if sent via courier, one (1) business
day after deposit with the courier service; or if sent via facsimile, upon
receipt of confirmation of transmission provided that a confirming copy of
such
Notice is sent by certified mail, postage prepaid, return receipt requested
or
by courier as set forth above.
12.7
Severability
and Reformation
.
If any
provision of this Agreement is held to be invalid or unenforceable by a court
of
competent jurisdiction, then the remaining provisions of this Agreement will
remain in full force and effect. Such invalid or unenforceable provision will
be
automatically revised to be a valid or enforceable provision that comes as
close
as permitted by law to the parties' original intent.
12.8
Headings
and Counterparts
.
The
headings of the articles and sections included in this Agreement are inserted
for convenience only and are not intended to affect the meaning or
interpretation of this Agreement. This Agreement may be executed in several
counterparts, all of which taken together will constitute the same
instrument.
12.9
Governing
Law
.
This
Agreement will be governed in accordance with the laws of the State of New
York,
without giving effect to the conflict of law provisions of any
jurisdiction.
12.10
Dispute
Resolution
.
If a
dispute arises between the parties concerning any right or duty under this
Agreement, then the parties will confer, as soon as practicable, in an attempt
to resolve the dispute. If the parties are unable to resolve the dispute
amicably, then the parties will
submit
to
the exclusive jurisdiction of, and venue in, the state and Federal courts
located in the State of New York with respect to all disputes arising 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 24b-2 of the Securities Exchange
Act of 1934.
12.11
Integration
.
This
Agreement, together with all attached Exhibits, contain the entire agreement
between the parties with respect to the Rockefeller Patent Rights and the
License and supersede all other oral or written representations, statements,
or
agreements with respect to such subject matter, including but not limited to
any
term sheet. Each party has caused this Agreement to be executed by its duly
authorized representative.
|
|
|
|
THE
ROCKEFELLER UNIVERSITY
|
ROSETTA
GENOMICS
|
|
|
|
|
|
|
By:
|
By:
|
|
Name:
John Tooze
Title:
Vice President
|
Name:
Amir Avniel
Title:
CEO
|
|
Address:
The
Rockefeller University
Office
of Technology Transfer
1230
York Avenue
502
Founders Hall
New
York, NY 10021
|
Address:
Rosetta
Genomics, Inc.
675
US Highway One
Suite
B119
North
Brunswick, NJ 08902
|
|
|
|
|
Required
copy
to:
The
Rockefeller University
Office
of General Counsel
1230
York Avenue, Box 81
New
York, NY 10021
|
|
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 24b-2 of the Securities Exchange
Act of 1934.
EXHIBIT
A
Rockefeller
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 24b-2 of the Securities Exchange
Act of 1934.
EXHIBIT
B
Development
Plan
Report
Requirements
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 24b-2 of the Securities Exchange
Act of 1934.
RESEARCH
SERVICES AGREEMENT
This
Research Services Agreement (“Agreement”) is entered into this 4th day of May,
2007, (the “Effective Date”) by and between Rosetta Genomics, Ltd., an Israeli
corporation, having its principal place of business at 10 Plaut Street, Rehovot,
Israel 76706 (“Rosetta”), and The Trustees of Columbia University in the City of
New York, having a principal place of business at c/o Science & Technology
Ventures, Columbia University, 630 West 168
th
Street,
PH 1535 East, New York, New York 10032 (“University”). Rosetta and University
may be referred to individually as a “Party” or collectively as
“Parties.”
RECITALS
WHEREAS,
Rosetta is engaged in the research and development of in vitro diagnostic tests
and has developed an algorithm based on a large number of microRNA in different
tumor types to identify Cancer of Unknown Primer (the “Test”); and
WHEREAS,
Rosetta requires the assistance of a CLIA and CAP (as such terms are hereinafter
defined) certified laboratory to validate, approve and perform the Test and
provide other research services (the “Research”); and
WHEREAS,
University is a research teaching institution and is interested in the
advancement of science and medicine; and
WHEREAS,
University provides CLIA and CAP certified laboratory testing services,
validates analytical methods and possesses the necessary technical capabilities,
equipment and facilities for the provision of the Services; and
WHEREAS,
Rosetta desires University to provide the Research; and
WHEREAS,
University is willing to provide the Research on the terms and conditions set
forth below.
NOW,
THEREFORE, in consideration of the mutual promises contained herein, and for
other good and valuable consideration, the receipt and adequacy of which each
of
the Parties does hereby acknowledge, the Parties, intending to be legally bound,
agree as follows:
ARTICLE
I.
ENGAGEMENT
OF UNIVERSITY
Rosetta
hereby engages University to perform the Research in accordance with the terms
and conditions set forth herein, and University hereby accepts such
engagement.
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 24b-2 of the Securities Exchange
Act of 1934.
ARTICLE
II.
ROSETTA
OBLIGATIONS
2.1.
Rosetta shall provide University with information about its proprietary Test,
and the Parties shall mutually agree to the validation procedure included in
Exhibit A, attached hereto and incorporated by reference, as amended from time
to time by mutual agreement of the Parties (the “Protocol”). The Protocol sets
out the roles of and obligations undertaken by Rosetta and University under
this
Agreement. In the event of any inconsistency between this Agreement and the
exhibits thereto, the terms of the Agreement shall control.
2.2.
Rosetta, in its sole discretion, may purchase and make available to University
equipment that will be used solely by the University during the term of this
Agreement to perform the Research and University may, in its sole discretion,
accept such equipment. Upon termination or expiration of the Agreement, or
if
sooner requested in writing by Rosetta, University shall return such equipment
to Rosetta.
2.3.
Rosetta shall assist University to obtain the biological samples required to
validate the Test, in the event that University does not obtain the number
of
biological samples as required under the Protocol.
ARTICLE
III.
UNIVERSITY
OBLIGATIONS
3.1.
University will conduct the Research in a laboratory located at its Health
Sciences campus, under the direction of Dr. Mahesh Mansukhani (the
“Laboratory”), in accordance with the Protocol.
3.2.
University will use reasonable efforts to validate the Test according to the
Protocol and shall provide the results in a form specified by Rosetta and agreed
to by the parties.
3.3.
University will use its reasonable efforts to obtain the number and type of
biological samples needed to validate the Test as specified in
Protocol.
3.4.
Upon
Rosetta’s written request, the University shall use reasonable efforts to
prepare its laboratory to perform the Test, including obtaining all required
reviews and approvals. University shall provide prompt written notice to Rosetta
as soon as it has completed the preparations and obtained the
approvals.
3.5.
University acknowledges that Rosetta intends to market the validated Test to
third parties. For a period of at least [***] months following Rosetta’s receipt
of the notice required in Section 3.4. (the “Trial Period”), the University
shall on a non-exclusive basis perform the Test.
3.6.
University shall perform the Research in accordance with all applicable laws
and
regulations, including the provisions of the Health Insurance Portability and
Accountability Act, that may apply to Research provided during the term of
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 24b-2 of the Securities Exchange
Act of 1934.
3.7.
University represents and warrants that as of the Effective Date, the Laboratory
is certified as a laboratory capable of performing the laboratory procedures
indicated on the CLIA and CAP certifications attached hereto as Exhibit B under
the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and that it is
also certified by the College of American Pathologists (“CAP”). University shall
use best efforts to maintain the Laboratory’s CLIA and CAP certifications during
the term of this Agreement and shall notify Rosetta immediately if it loses
or
learns that it is about to lose either certification.
3.8.
In
situations when Rosetta provides material or equipment to University, University
shall use such material and equipment only for providing the Research.
University shall take due care to protect the equipment from damage, vandalism,
and theft and to prevent the use of the equipment for uses not outlined in
the
equipment operating manual.
3.9.
Upon
reasonable advance written notice, University shall permit representatives
of
Rosetta to have access at reasonable times to the facilities of University
where
the Research is performed for the sole purpose of observing the performance
of
the Research and/or reviewing the records, documentation or other data relating
to the Research. This provision shall survive termination or expiration of
this
Agreement for a period of [***] years.
ARTICLE
IV.
COMPENSATION
4.1.
Rosetta shall make payment to University for the support of the Research in
accordance with the fee and payment schedule included in Exhibit C, attached
hereto and incorporated by reference. University shall not bill any person
other
than Rosetta for the Research performed hereunder.
4.2.
Unless otherwise agreed to by the Parties, upon the occurrence of each payment
milestone University shall provide Rosetta with a separate invoice that
summarizes the Research performed during that relevant period. Rosetta shall
pay
University by check or wire transfer to a bank account designated in writing
by
University within fourteen (14) days of Rosetta’s receipt of an
invoice.
4.3.
Checks shall be drawn to the account of The Trustees of Columbia University
in
the City of New York, and mailed to the following address:
THE
TRUSTEES OF COLUMBIA UNIVERSITY
IN
THE
CITY OF NEW YORK
Columbia
University - Restricted Funds/STV
P.O.
Box
1505
New
York,
NY 10008-1505
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 24b-2 of the Securities Exchange
Act of 1934.
ARTICLE
V.
TERM
AND TERMINATION
5.1.
This
Agreement shall commence on the Effective Date and shall expire the sooner
of a
period of two (2) years or through at the end of the Trial Period, unless
terminated earlier as provided herein or extended by mutual written consent
of
the Parties (“Research Period”). The parties may elect, upon mutual written
agreement, to lengthen the Trial Period for a period of additional six (6)
months (altogether twelve (12) months. If the Parties desire to extend their
relationship beyond the Trial Period and have University serve as a contract
laboratory to perform the Test on behalf of Rosetta, they will negotiate a
new
agreement for such services. University does not warrant that the Research
shall
be completed by the end of the Research Period.
5.2.
This
Agreement may be terminated:
(a)
by
Rosetta for any reason upon [***] days written notice to University;
provided that, Rosetta pays University all amounts due for the support of the
Research and any noncancellable commitments incurred by University as of the
date University receives Rosetta’s notification of its intent to terminate the
Agreement.
(b)
by
either Party if the other Party breaches a material provision of this Agreement
and fails to cure such breach to the reasonable satisfaction of the
non-breaching Party within thirty (30) days following written notification
of
such breach.
5.3.
In
the event of termination, University shall be compensated for Research performed
up to the date of termination.
5.4.
Effect of Expiration or Termination.
(a)
On
and as of the effective date of any termination or expiration, University shall
(i) promptly transfer all information in its possession used in providing the
Research including without limitation, all technical information and know-how
related to the validation of the Test, and all other information relating to
the
Research, including the results of the validation, that is useful to enable
Rosetta or a third party to perform the Test, make any regulatory submission,
or
provide Test results to medical professionals; and (ii) promptly return any
materials or equipment provided to it by Rosetta.; provided that, in the event
that the Agreement is terminated by University in accordance with Section
5.2(b), University will not be obligated to comply with Section 5.4(a)(i) and
all rights granted to Rosetta herein shall automatically terminate on the date
of termination of this Agreement.
(b)
Articles 2.2, 3.8, 4.l, 5.3, 5.4, VI, VII , IX, X and XI shall survive the
expiration or termination of this Agreement. In addition, University hereby
acknowledges that neither expiration nor termination of this Agreement shall
affect in any manner Rosetta’s right to perform or have the Test performed by
Rosetta or a third 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 24b-2 of the Securities Exchange
Act of 1934.
ARTICLE
VI.
RESERCH
REPORTS AND INVENTIONS
(a)
All
data, reports, information, discoveries, or improvements developed by University
in the performance of the Research hereunder shall be provided to the Company
in
research reports (“Research Reports Information”). The Company may use the
Research Report Information for any purpose whatsoever, and the University
may
use the Research Report Information for non-commercial, internal and academic
purposes and in accordance with the publication provisions set forth in Sections
10.3
and
10.4.
(b)
Inventorship of any inventions shall be determined according to U.S. patent
laws
and ownership shall follow inventorship. University hereby grants to Rosetta
an
option to obtain an exclusive or a non-exclusive license, at Rosetta’s election,
through good faith negotiation and on commercially reasonable terms, to any
and
all of University’s rights in any invention developed by University under this
Agreement. This option to obtain the license shall extend for a period of six
(6)
months
following formal written disclosure of the invention to Rosetta.
ARTICLE
VII.
CONFIDENTIALITY
7.1.
As
of the Effective Date, University agrees to use its best efforts to treat all
Confidential Information (as described herein) disclosed by Rosetta under this
Agreement as being secret and confidential. For the purposes of this Agreement,
“Confidential Information” shall mean all confidential or proprietary materials
or information disclosed by an officer of Rosetta not generally available to
the
public that is confidential and proprietary to Rosetta, including, but not
limited to, all information regarding the Test, any analytical procedures,
processes, know-how, the Protocol and other information related to any test
that
may or will be under development. The parties agree that any information
disclosed by Rosetta to a non-officer of University shall only be considered
to
be Confidential Information under this Agreement if that non-officer executes
a
non-disclosure agreement with Rosetta. University shall not disclose the
Confidential Information nor use it for any purposes other than as required
in
the performance of its duties under this Agreement.
7.2.
The
provisions of Article 7.1 shall not apply to any information disclosed hereunder
that:
(a)
was
known to University prior to its date of disclosure by Rosetta as evidenced
by
University’s written records;
(b)
is
disclosed lawfully to University either before or after the date of the
disclosure by Rosetta, by a third party rightfully in possession of the
Confidential Information without an obligation of confidentiality;
(c)
is
published or generally known to the public, either before or after the date
of
disclosure through no fault or omission on the part of University;
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 24b-2 of the Securities Exchange
Act of 1934.
(d)
is
independently developed by University without reference to or in reliance upon
the Confidential Information; and
(e)
is
required to be disclosed by University to comply with applicable laws, to defend
or prosecute litigation or to comply with governmental regulations, provided
that University provides prior written notice of such disclosure to Rosetta
and
takes reasonable and lawful actions to avoid and/or minimize the degree of
such
disclosure.
7.3.
The
obligations of confidentiality set forth in this Agreement shall survive its
termination or expiration for a period of [***].
ARTICLE
VIII.
INSURANCE
University
shall obtain and maintain during the term of this Agreement and for a reasonable
period thereafter insurance as is necessary to cover its employees and any
liability that might arise out of the Research performed under this
Agreement.
ARTICLE
IX.
INDEMNIFICATION;
NO WARRANTIES
9.1
Each
Party agrees to assume any and all risks of personal injury and property damage
attributable to the negligent acts or omissions of that Party or its officers,
employees and agents.
9.2
NOTHING
IN THIS AGREEMENT WILL BE CONSTRUED AS A PROMISE OR REPRESENTATION BY UNIVERSITY
TO ACHIEVE ANY SPECIFIC OR USABLE RESEARCH RESULT OR THAT THE RESEARCH WILL
BE
COMPLETED BY THE END OF THE RESEARCH PERIOD.
9.3
UNIVERSITY IS PROVIDING THE RESEARCH REPORT INFORMATION ON AN “AS IS” BASIS.
UNIVERSITY MAKES NO WARRANTIES EITHER EXPRESS OR IMPLIED OF ANY KIND, AND HEREBY
EXPRESSLY DISCLAIMS ANY WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND
AS
TO THE RESEARCH REPORT INFORMATION.
9.4
The
University will use best efforts to select Samples that will meet the criteria
set forth in the Protocol. The parties acknowledge that any biological samples
utilized by the parties and exchanged between the parties during the course
of
performing the Research are provided “AS IS” AND WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY,
EXPRESS OR IMPLIED. THE PARTIES MAKE NO REPRESENTATION OR WARRANTY THAT THE
USE
OF
THE
BIOLOGICAL MATERIALS WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT
OR
THAT THE BIOLOGICAL MATERIALS WILL NOT POSE A HEALTH OR SAFETY RISK
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 24b-2 of the Securities Exchange
Act of 1934.
9.5
In no
event shall University’s liability to Rosetta exceed the payments made to
University by Rosetta under this Agreement.
9.6
The
parties hereto acknowledge that the limitations and exclusions of liability
and
disclaimers of warranty set forth in this Agreement form an essential basis
of
the bargain between the parties.
9.7
Rosetta
will indemnify, defend and hold University, its trustees, officers, faculty
members, students, employees and agents (“Indemnities”) harmless from and
against any and all actions, suits, claims, demands, prosecutions, liabilities,
costs, expenses, damages, deficiencies, losses or obligations brought by a
third
party (including reasonable attorneys fees) (“Claims”) based on or arising out
of its use of the Research Report Information except to the extent that any
Claim is caused by the gross negligence or malfeasance of one or more
Indemnity.
ARTICLE
X
.
PUBLICITY
AND PUBLICATIONS
10.1.
Neither Rosetta nor University shall make any news release or other public
statement, whether to the press or otherwise, disclosing the existence of this
Agreement or the terms thereof without the prior written approval of the other
Party, except as required by law.
10.2.
Rosetta will not use the name, insignia, or symbols of University, its faculties
or departments, or any variation or combination thereof, or the name of any
trustee, faculty member, other employee, or student of University for any
purpose whatsoever, except those required by law, without University’s prior
written consent.
10.3.
Subject to Section 10.4, University shall have the right, consistent with
academic standards, to publish or present the results of the Research provided
that the manuscript, abstract or other material proposed to be published or
presented (“Proposed Publication”) shall be submitted to Rosetta at
least [***] days prior to submission for publication or presentation
to permit Rosetta to request removal of any Confidential Information contained
therein and to patentable invention disclosed therein. Rosetta shall complete
its review within [***] days after receipt of the Proposed Publication. If
Rosetta believes that any Proposed Publication contains any information relating
to any patentable invention the disclosure of such Proposed Publication shall
be
delayed for [***] days from the date of receipt of the Proposed Publication
to
permit the filing of a patent application. If Rosetta believes that any Proposed
Publication contains confidential information, Rosetta shall so notify
University and University shall remove any such Confidential Information prior
to publication or presentation.
10.4.
If
the Research is part of a multi-center study, the University agrees that it
will
not publish until after the data from the multi-center study is published in
a
combined paper that identifies all the sites, including Rosetta, that
participated in that in the event that the multi-center publication has not
been
completed within [***] years from the date of the expiration or termination
of
this Agreement, University may publish or present its individual results of
the
Research hereunder, provided further that the Proposed Publication is first
reviewed by Rosetta in accordance with Section 10.3.
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 24b-2 of the Securities Exchange
Act of 1934.
10.5.
Rosetta acknowledges that University is dedicated to free scholarly exchange
and
to public dissemination of the results of its scholarly activities. Except
for
University’s obligations set forth in Sections 10.3 and 10.4 and Article VII,
nothing in this Agreement shall restrict the right of University and its faculty
and other employees to publish, disseminate or otherwise disclose the
Research.
ARTICLE
XI.
NOTICES
All
notices or other communications that are required or permitted by this Agreement
shall be in writing and shall be delivered personally, sent by facsimile (and
promptly confirmed by personal delivery, registered or certified mail or
overnight courier), sent by internationally recognized overnight courier or
sent
by registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:
|
|
|
|
|
|
|
Rosetta
Genomics, Ltd
|
|
|
|
10
Plaut Street
|
|
|
|
Science
Park
|
|
|
|
POB
4059
|
|
|
|
Rehovot,
L3 76706
|
|
|
|
Israel
|
|
|
|
Attn:
|
|
|
|
Facsimile
No.: +972 8 948 4766
|
|
|
|
|
|
With
a copy to:
|
|
Rosetta
Genomics, Inc.
|
|
|
|
675
U.S. Highway One, Suite B 119
|
|
|
|
New
Brunswick,
NJ
08902
|
|
|
|
Attn:
|
|
|
|
Facsimile
No.: 732 246 9988
|
|
|
|
|
|
If
to University:
|
|
Executive
Director
|
|
|
|
Science
and Technology Ventures
|
|
|
|
80
Claremont Avenue #4F
|
|
|
|
New
York, NY 10027
|
|
|
|
facsimile:
1-212-854-8463
|
|
|
|
|
|
With
a copy to:
|
|
General
Counsel
|
|
|
|
412
Low Library, MC 4308
|
|
|
|
535
West 116
th
Street
|
|
|
|
New
York, NY 10027
|
|
|
|
Facsimile
No.: 1-212-222-8505
|
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 24b-2 of the Securities Exchange
Act of 1934.
ARTICLE
XII.
STATUS
OF THE PARTIES
This
Agreement shall not be deemed to create any partnership, joint venture, or
agency relationship between the Parties. Each Party shall act hereunder as
an
independent contractor and its agents and employees shall have no right or
authority under this Agreement to assume or create any obligation on behalf
of,
or in the name of, the other Party. All persons employed by a Party shall be
employees of such Party and not of the other Party, and all costs and
obligations incurred by reason of any such employment shall be for the account
and expense of such Party.
ARTICLE
XIII.
MISCELLANEOUS
13.1.
This Agreement, including any attachments, may not be altered, amended or
modified except by a written document signed by both Parties.
13.2.
University shall not assign any of its rights or obligations under this
Agreement without the prior written authorization of Rosetta.
13.3.
This Agreement and all rights and obligations hereunder shall not be assigned
(whether through merger or consolidation, by operation of law, or otherwise);
provided, however, that Rosetta may assign this Agreement and its rights and
obligations hereunder upon written notification to the University, to an
Affiliate in connection with the transfer or sale of all or substantially all
of
its assets related to the Test or its business in the event of its merger or
consolidation or change in control or similar transaction and provided further
that any permitted assignee shall assume all obligations of Rosetta under this
Agreement in writing. Any assignment or attempted assignment contrary to the
provisions hereof shall be null and void.
13.4.
This Agreement shall be binding upon and inure to the benefit of the Parties
hereto and each of their respective successors and assigns.
13.5.
All
agreements and covenants contained herein are severable, and in the event any
of
them shall be held to be invalid by any competent court, this Agreement shall
be
interpreted as if such invalid agreements or covenants were not contained
herein.
13.6.
This Agreement constitutes the entire agreement between the Parties and
supersedes all prior communications, representations, or agreements, either
verbal or written between the Parties. Each Party confirms that it is not
relying on any representations or warranties of the other Party except as
specifically set forth herein.
13.7.
The
waiver by either Party of any right hereunder shall not be deemed a waiver
of
any other right hereunder.
13.8.
This Agreement may be executed in two (2) or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one
and
the same instrument.
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 24b-2 of the Securities Exchange
Act of 1934.
13.9.
The
headings used in this Agreement are for convenience only and are not a part
of
this Agreement.
13.10.
This Agreement shall be construed and enforced in accordance with the laws
of
the State of New York, without application of its principles of conflict of
laws.
[signatures
on following page]
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 24b-2 of the Securities Exchange
Act of 1934.
IN
WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to be
executed by its duly authorized representative as of the date written
above.
|
ROSETTA GENOMICS,
LTD
|
|
|
THE TRUSTEES OF
COLUMBIA
|
|
|
|
|
|
UNIVERSITY
IN THE CITY OF NEW YORK
|
|
|
|
|
|
|
|
|
|
|
|
|
5/7/07
|
|
Name:
|
Date
|
|
|
Date
|
|
Title:
|
|
|
|
|
|
|
|
|
SCIENCE
&
TECHNOLOGY
VENTURES
|
|
|
Read and Understood:
|
|
|
|
|
|
|
|
|
|
|
|
5/7/07
|
|
|
|
Name: Mahesh
Mansukhani, MD
|
Date
|
|
|
|
|
Assoc.
Director, Molecular Pathology Laboratory
|
|
|
|
|
|
Assistant
Professor of Clinical Pathology
|
|
|
|
|
|
|
|
|
|
|
|
5/7/07
|
|
|
|
Name: Michael
Shelanski, MD PhD
|
Date
|
|
|
|
|
Chair,
Department of Pathology
|
|
|
|
|
Delafield
Professor of Pathology
|
|
|
|
|
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 24b-2 of the Securities Exchange
Act of 1934.
IN
WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to be
executed by its duly authorized representative as of the date written
above.
|
ROSETTA GENOMICS,
LTD
|
|
|
THE TRUSTEES OF
COLUMBIA
|
|
|
|
|
|
UNIVERSITY
IN THE CITY OF NEW YORK
|
|
|
|
|
|
|
|
|
5/7/07
|
|
|
|
Name:
Amir
Avniel
|
Date
|
|
Name:
|
Date
|
|
Title:
President
and CEO
|
|
|
Title:
|
|
|
Read and Understood:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name: Mahesh
Mansukhani, MD
|
Date
|
|
|
|
Assoc.
Director, Molecular Pathology Laboratory
|
|
|
|
|
Assistant
Professor of Clinical Pathology
|
|
|
|
|
|
|
|
|
Name: Michael
Shelanski, MD PhD
|
Date
|
|
|
|
Chair,
Department of Pathology
|
|
|
|
Delafield
Professor of Pathology
|
|
|
|
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 24b-2 of the Securities
Exchange
Act of 1934.
EXHIBIT
A
Protocol
Clinical
Validation of Rosetta Genomics’ MiRNA assay for Cancer of Unknown Primary (CUP)
with Mahesh Mansukhani, Associate Director of Molecular Pathology Laboratory,
Department of Pathology, Columbia University Medical
Center
Project
Goal:
The
goal
is to validate the Rosetta Genomics microRNA profiling assay to identify the
primary origin of metastatic cancers. The study will use the collection of
FFPE
samples of primary and metastatic cancers from the Department of Pathology
of
Columbia University Medical Center. MicroRNA analysis will be performed on
blinded samples at CUMC, and accuracy of microRNA profiling will be determined.
Should the accuracy be acceptable, then an additional set of blinded samples
will be tested at CUMC molecular pathology laboratory for the development of
a
clinical diagnostic assay, to identify the primary site of CUPS. The ultimate
goal is to obtain data to allow the identification of sensitivity and
specificity of the assay for various primaries, to allow submission data to
the
New York State Department of Health Clinical Laboratory Evaluation Program.
These data will be submitted from the CUMC Molecular Pathology Laboratory,
PFI7313.
Background:
MicroRNAs
(mirs) are short non-coding RNAs that regulate gene expression through
post-transcriptional suppression of mRNA. They are associated with cancer and
development, and demonstrate tissue specificity. 3%-5% of cancers present as
metastatic cancers with an unknown primary. The process of identifying the
source of the primary tumor is lengthy, expensive, and often inaccurate.
Rosetta
Genomics has developed a platform for profiling and characterizing all known
and
several hundred novel human microRNAs. Protocols have been developed for the
reliable extraction of RNA from formalin-fixed, paraffin-embedded (FFPE)
archival tissue samples, in a manner that retains the microRNA fraction. In
addition, the protocols also reliably extract microRNAs from fresh/frozen
tissues. For accurate, high-throughput measurement of microRNA expression
levels, a microarray platform with probes for nearly 700 microRNAs has been
developed. MicroRNA expression levels have been measured and tissue-specific
microRNAs identified with these protocols. In addition, we have constructed
and
optimized a simple algorithm to classify samples into tissue type categories.
In
addition, the design of the algorithm allows us to easily trace the strong
points in the classification, and to incorporate additional information where
required.
Using
the
above methods, protocols and algorithms, to analyze several hundred tumor and
normal tissue samples obtained from patients with 15 distinct tumor types ,
tissue source was identified using only a small number of microRNAs. Overall,
the accuracy of determining tissue origin of tumors reached ~85%, with increased
accuracy observed in subsets of tumor categories.
In
conclusion, tissue specificity of microRNAs permits the identification of tumor
origin based on a surprisingly small number of microRNA. Furthermore, the
development of a microRNA-based algorithm further enables the determination
of
the tissue origin. These findings will enable the development of an important
diagnostic assay for clinicians.
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 24b-2 of the Securities Exchange
Act of 1934.
Protocol:
[***] at
Columbia. The anticipation is that [***].
Primary
Tumors:
[***]
Columbia
Study Plan:
To
identify the appropriate samples to be assayed for microRNA profiling in full
agreement with Rosetta Genomics. All relevant clinical information to allow
the
unambiguous identification of [***].
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 24b-2 of the Securities Exchange
Act of 1934.
The
CUMC
molecular pathology staff will collaborate with Rosetta Genomics in data
analysis necessary for project goals. Should the analytical performance
characteristics be satisfactory, [***].
Rosetta
Genomics Study Plan:
[***].
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 24b-2 of the Securities Exchange
Act of 1934.
EXHIBIT
B
CLIA
and CAP Certificates
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 24b-2 of the Securities Exchange
Act of 1934.
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 24b-2 of the Securities Exchange
Act of 1934.
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 24b-2 of the Securities Exchange
Act of 1934.
EXHIBIT
C
Budget
Budget
per Validation Phase (estimated between 3 and 6 months in
duration):
|
Payment
|
|
Due
Date
|
|
Direct
Costs
|
|
Indirect
Costs (25%)
|
|
Total
Amount Due
|
|
|
1
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
Budget
per Laboratory Preparation Period (estimated 3 months in
duration):
|
Payment
|
|
Due
Date
|
|
Direct
Costs
|
|
Indirect
Costs (25%)
|
|
Total
Amount Due
|
|
|
1
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
41,668
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
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 24b-2 of the Securities Exchange
Act of 1934.
Budget
per Trial Period (Six months in duration)*
|
Payment
|
|
Due
Date
|
|
Direct
Costs
|
|
Indirect
Costs (25%)
|
|
Total
Amount Due
|
|
|
1
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6
|
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$
|
[***]
|
|
$
|
[***]
|
|
$
|
[***]
|
|
*
In
the
event that the parties agree to extend the Trial Period for an additional [***],
then
the
U
niversity
will be entitled to an additional payment of $[***]
.
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 24b-2 of the Securities Exchange
Act of 1934.
