Research Collaboration Agreement
This
agreement (this “Agreement”)
is
made and entered into as of the 16th day of May 2006 (the “Effective
Date”)
by and
between Rosetta
Genomics Ltd.,
a
private company registered pursuant to the laws of the State of Israel, of
▇▇
▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, Israel (“Rosetta”)
and
Tel
Hashomer Medical Research Infrastructure and Services Ltd. a company duly
registered under the laws of the state of israel (hereinafter:
“THM”),
located at Tel Hahsomer, ▇▇▇▇▇ ▇▇▇▇▇▇ established pursuant to the laws of the
State Of Israel (“THM”).
WHEREAS,
ROSETTA has developed confidential and proprietary technology relating to
microRNA sequences including an algorithm for the prediction of microRNAs,
techniques for validation of predicted microRNAs on a given material, microRNA
expression profiling technology, analysis algorithms for the detection of
biomarkers based on microRNA expression profiling and techniques for
establishing the relationships between microRNAs and diseases and has identified
a large number of microRNA sequences using certain of its proprietary technology
and/or proprietary materials; and
WHEREAS,
THM
is a
non-profit organization established for “the benefit of the public” whose
purpose is to promote the welfare of the Sheba Medical Center (the “Hospital”)
with
respect to scientific collaborations and studies; AND
WHEREAS,
Rosetta and THM desire to collaborate in a research project pursuant to which
THM will supply Rosetta with patients’ specimens (“Study
Specimens”)
and
related data (collectively, “Materials”),
and
shall perform certain activities as specified hereunder, in order for Rosetta
to
utilize its proprietary technology and know-how for the research of the
expression of Rosetta MicroRNAs (as defined below) and additional publicly
known
microRNAs in the Materials pertaining to a diagnostic application (the
“Research
Project”);
and
WHEREAS,
the parties wish to set forth herein the definitive terms of the collaboration
of the parties with respect to the performance of the Research Project and
the
future rights to any of its results;
NOW
THEREFORE, the parties, intending to be legally bound, hereby agree as
follows:
| 1. |
Definitions.
In addition to those terms defined elsewhere in this Agreement, each
of
the following terms shall have the meaning set forth opposite it,
unless
the context otherwise requires:
|
| 1.1. |
“Intellectual
Property”
shall mean all intellectual property, whether or not protected by
patents
or patent applications, including, but not limited to, trade secrets,
procedures, protocols, inventions, databases, know how, inventions,
improvements, discoveries, conceptions, ideas, techniques, designs,
products, developments, specifications, methods, drawings, diagrams,
models, software programs, data, data analysis, data interpretation,
written reports, and all rights therein including copyright, patent
rights, database rights, rights in designs and all registrations
and
applications therefore, and all continuations, continuations in part,
divisional applications, and renewals of any of the foregoing, in
any part
of the world.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Neither
party claims by virtue of this Agreement any right, title, or interest in
Intellectual
Property
of the
other party or is not subject to this agreement between the
Parties.
| 1.2. |
“Proprietary
Information”
shall mean any and all scientific, clinical, regulatory, marketing,
financial and commercial information or data, including the terms
of this
Agreement, whether communicated in writing, orally or by any other
means,
which is provided by one Party to the other Party in connection with
this
Agreement.
|
| 1.3. |
“Rosetta
IP”
shall mean any and all Intellectual Property that Rosetta has developed
or
which Rosetta owns, as evidenced in written records, including but
not
limited to the Rosetta MicroRNAs.
|
| 1.4. |
“Research
Results”
shall mean any and all microRNAs expression profiling data measured
on the
Materials, and its analysis pertaining to potential diagnostic
application, as determined in the course of the performance of the
Research Project.
|
| 1.5. |
“Rosetta
MicroRNAs”
shall mean any novel human and non-human (including virus and bacteria)
microRNAs predicted by Rosetta prior to the execution of this Agreement,
as evidenced in writing.
|
| 1.6. |
“THM’s
IP”
shall mean any and all Intellectual Property developed and/or conceived
and/or made and/or discovered and/or reduced to practice and/or owned
by
THM and/or by Sheba Medical Center and/or by Medical Research
Infrastructure Development and Health Services Fund by the Sheba
Medical
Center (the “Fund”).
|
| 2. |
The
Research Project.
|
The
parties will collaborate in the performance of the Research Project, pursuant
to
the following terms and conditions:
| 2.1. |
The
Research Project shall include multiple trials as agreed upon by
the
Parties (the “Trials”),
each Trial shall be performed in accordance with a Trial Protocol
to be
prepared by Rosetta for each Trial and agreed upon by THM (the
“Protocol”).
Each Protocol will be attached to this agreement as Appendix A1,
A2 and so
forth and constitute an integral part of this Agreement. The remuneration
for each Trial shall be agreed upon by both Parties in advance and
shall
be specified in a budget schedule, executed by both Parties for each
Trial
and attached to the Trial’s Protocol (the “Budget
Schedule”).
The Budget Schedule of each Trial shall be attached to this agreement
as
▇▇▇▇▇▇▇▇ ▇▇, ▇▇ and so forth and constitute an integral part of this
Agreement, the Protocol and the Budget Schedule collectively hereinafter:
the “Protocol
Plan”;
The Protocol Plan for each Trial shall constitute an integral part
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 406 of the Securities Act.
| 2.2. |
The
first Trial shall be conducted according to the Protocol attached
to this
Agreement as Appendix
A1
and constituting an integral part thereof (“Protocol
A1”).
THM and Rosetta shall perform the activities mentioned in Protocol
A1. THM
shall perform the activities designated to it in Protocol A1 and
in any
other Protocol, directly or by employing the services of the Fund
or any
other third party to be agreed between THM and Rosetta (the entity
who
shall carry out the Trials on the part of THM: “the
Research Entity”).
|
| 2.3. |
Rosetta
shall oversee the conduct of the Research Project. THM shall designate
a
senior researcher currently contemplated to be ▇▇▇▇. ▇▇▇▇▇▇ Rechavi
(the
“Investigator”)
to collaborate with Rosetta in carrying out THM’s activities related to
the Research Project.
|
| 2.4. |
A
part of Rosetta’s activities under the Research Project shall be conducted
in the facilities of the Hospital (“Rosetta’s
Work”)
by Rosetta’s employees and/or agents and/or representatives and/or
contractor’s (“Rosetta’s
Personnel”).
|
| 2.4.1. |
Rosetta’s
Personnel shall be skillful, prudent, professionals and experienced
in the
field of the Research Project and shall hold any license and be qualified
and authorized to perform Rosetta’s Work in accordance with the
requirements of the applicable laws, regulations and
guidelines.
|
| 2.4.2. |
Rosetta’s
Work shall be performed by Rosetta’s Personnel in strict accordance with
the Hospital’s and/or the Research Entity’s and/or THM’s internal
guidelines and/or rules and/or directives relating to Rossetta’s Work
and/or to the work performed at the Hospital’s facilities or to the
Hospital’s and/or the Research Entity’s devises, instruments or
systems.
|
| 2.4.3. |
Without
derogating from anything to the contrary in this Agreement, Rosetta’s
Personnel shall obey all administrative instructions of the Investigator
or any other person designated by the Research Entity for such purpose
(“Site’s
Supervisor”).
Site’s Supervisor shall determine the exact dates and hours during which
Rosetta’s Work shall be performed at the
Hospital.
|
| 2.4.4. |
Rosetta’s
Personnel shall be deemed independent contactors and/or Rosetta’s
employees, and shall not be considered a partner, agent, employee
or
representative of the Research Entity and/or of
THM.
|
| 2.5. |
Either
party may conduct additional research projects, independently or
with
other third parties, in parallel to or following the Research Project,
and
nothing in this Agreement shall prevent a party from engaging in
any
additional research, provided that it fulfills its obligations
hereunder.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 2.6. |
Each
party represents and warrants that it is legally authorized and entitled
to assume all responsibilities under this
Agreement.
|
| 2.7. |
It
is a condition precedent to the validity of this Agreement with respect
to
each Trial that this Agreement shall come into effect with respect
to each
Trial only after approval is received from: the Helsinki Committee
and the
Hospital’s Committee for Research Contracts with Commercial Companies. The
approval of the Helsinki Committee shall approve all the following:
(a)
the Protocol of the Trial (b) the transfer of the Study Specimens
to
Rosetta, (c) the use of the Study Specimens under the study to be
conducted by Rosetta (the “Study”)
(d) the Study. The performance of each Trial shall commence only
after the
Helsinki Committee approves the above with respect to such
Trial.
|
| 2.8. |
Both
parties undertake to perform the Research Project, in compliance
with the
following: (1) the Ministry Guidelines, as defined herein (2) the
instructions and the terms specified in the approval of the Helsinki
Committee (3) the ICH-GCP (4) the applicable laws, rules and regulations
regulating such studies which are applicable in Israel. The “Ministry
Guidelines”
the MOH Guidelines titled “Clinical Trials of Human Subjects” issued in
January 2006 including appendix 4 to the
guidelines.
|
| 2.9. |
Rosetta
shall use the Study Specimens solely for the purpose of the Study
and not
for any other purposes whatsoever.
|
| 2.10. |
Rosetta
shall use and dispose of the Study Specimens in accordance with the
State
of Israel’s laws, rules, regulations and guidelines regulating and/or
applicable and/or relevant to the use of the Study Specimens under
the
Study and to their disposal following the completion of the
Study.
|
| 2.11. |
Immediately
following the completion of the Study or the use of any Study Specimen
under the Study, Rosetta shall dispose of or terminate the Study
specimens
as specified above.
|
| 2.12. |
Rosseta
shall keep full and accurate records with respect to the use and
to the
dates and manner of disposal of each and every Study Specimen and
shall
provide such records to the Research Entity for examination, upon
the
Research Entity’s request.
|
| 2.13. |
For
the removal of doubt it is hereby clarified that nothing specified
in this
Agreement shall be construed as a warranty by THM that the Research
Project’s results or the results of any Trial shall be useful in any
manner or commercially exploitable.
|
| 3. |
Permitted
Uses of Information, Rights to the Research Results and Intellectual
Property.
|
| 3.1. |
THM
may use the information provided by Rosetta regarding the results
of the
Research Project under the terms of this agreement for research and
academic purposes only. Notwithstanding the confidentiality obligations
of
▇▇▇▇▇▇▇ ▇, ▇▇▇ may publish the information in accordance with Section
6
below.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 3.2. |
THM
agrees that all right, title and interest in and to the Research
Results
and any intellectual property deriving there from, whether they shall
be
protected by intellectual property rights or not, shall be solely
owned by
and vest with Rosetta. Without limiting the above, Rosetta shall
be solely
entitled, as it may deem fit, to file, in its name, patents and patent
applications with respect to any Research Results, to publicize the
Research Results and to commercially or otherwise exploit the Research
Results Provided however that THM’s investigators shall be registered as
“Inventors” in any such patent
application.
|
| 3.3. |
Each
party shall remain the sole owner of its own Intellectual Property.
It is
hereby expressly agreed that, nothing in this Agreement shall constitute
or be considered as constituting a transfer or license of any Intellectual
Property by one party to the other.
|
| 4. |
Costs
of Research.
|
| 4.1. |
Rosetta
agrees to bear [***] costs related to the performance of the experiments
in relation to the Research Project, [***], all as indicated in the
Budget
Schedule of each Trial. The Budget Schedule of the first Trial specified
in Protocol A1 is attached as Appendix
B1.
|
| 4.2. |
Rosetta
will reimburse THM for [***] the Material provided by THM pursuant
to this
Agreement according to Appendix C.
|
| 4.3. |
In
addition, Rosetta will pay THM all the amounts specified in Section
8
herein (Royalties).
|
| 5. |
Confidentiality.
|
| 5.1. |
Non-Disclosure
and Non-Use Obligations
|
All
Proprietary Information disclosed by one Party to the other Party hereunder
shall be maintained in confidence and shall not be disclosed to any Third Party
or used for any purpose except as expressly permitted herein without the prior
written consent of the Party that disclosed the Proprietary Information to
the
other Party. The foregoing non-disclosure and non-use obligations shall not
apply to the extent that such Proprietary Information: (i) is known by the
receiving Party at the time of its receipt, and not through a prior disclosure
by the disclosing Party, as documented by contemporaneous written records;
(ii)
is in the public domain or knowledge; (iii) is subsequently disclosed to a
receiving Party by a Third Party who may lawfully do so and is not under an
obligation of confidentiality to the disclosing Party; or (iv) is developed
by
the receiving Party independently of Proprietary Information received from
the
other Party, as documented by contemporaneous research and development
records.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 5.2. |
Permitted
Disclosure of Proprietary Information.
|
Notwithstanding
Section 5.1, a Party receiving Proprietary Information of another Party may
disclose such Proprietary Information: (i) to governmental or other regulatory
agencies in order to obtain patents on Products, or to gain approval to conduct
clinical trials or to market Products, but such disclosure may be only to the
extent reasonably necessary to obtain such patents or authorizations; (ii)
to
its respective agents, consultants, Affiliates, sublicensees and/or other Third
Parties for the research and development, manufacturing and/or marketing of
Products (or for such parties to determine their interests in performing such
activities) on the condition that such Third Parties agree to be bound by the
confidentiality obligations contained in this Agreement; (iii) if required
to be
disclosed by law or court order, provided that notice is promptly delivered
to
the disclosing Party in order to provide an opportunity to challenge or limit
the disclosure obligations; (iv) potential investors; and (v) regulatory
authorities. Provided,
however,
without
limiting any of the foregoing, it is understood that either Party or its
Affiliates may make disclosure of this Agreement and the terms hereof in any
filings required by the SEC, may file this Agreement as an exhibit to any filing
with the SEC and may distribute any such filing in the ordinary course of its
business. However, to the maximum extent allowable by SEC rules and regulations,
the Parties shall be obligated to maintain the confidentiality obligations
set
forth herein and shall redact any confidential information set forth in such
filings. Notwithstanding the aforementioned it is hereby agreed that THM is
entitled to disclose the terms of this Agreement to the Hospital, the Fund
and
any other party which was established in connection with or for the benefit
of
the Hospital, but in no event shall THM be entitled to disclose the terms of
this Agreement to any other hospitals, research institutions and tech transfer
offices of such institutes, without first receiving the written prior approval
of Rosetta.
| 6. |
Publications.
Notwithstanding Rosetta’s rights set out in Section 3 above, THM shall
have the right to publish the Research Results in scientific publications
or to present such results at scientific symposia, provided that
the
following procedure is followed:
|
| 6.1. |
No
later than 60 days prior to submission for publication of any scientific
articles, abstracts or papers concerning Research Results or Research
Project and prior to the presentation of such results at any scientific
symposia, THM shall send to Rosetta a written copy of the material
to be
so submitted or presented, and shall allow Rosetta to review such
submission to determine whether the publication or presentation contains
confidential information or subject matter for which patent protection
should be sought prior to publication or presentation for the preservation
of patent rights.
|
| 6.2. |
Rosetta
shall provide its comments with respect to such publication or
presentation, as the case may be, within 30 days following its receipt
of
such written material. The Investigator shall give due consideration
to
Rosetta’s comments.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 6.3. |
If
Rosetta, in its written comments, identifies material for which patent
protection should be sought, then THM shall cause the publication
or
presentation of such submission to be delayed for a further period
of up
to 60 days from the receipt of such written comments to enable Rosetta
to
make the necessary patent filings.
|
| 6.4. |
THM
shall name Rosetta scientists as authors in accordance with scientific
custom.
|
| 6.5. |
In
the event that Rosetta publishes the Rosetta Results, Rosetta shall
name
the Investigator and The Institute as authors in accordance with
scientific custom.
|
| 7. |
Term
and Termination.
|
| 7.1. |
The
term of each Trial, and the Parties’ right to terminate each Trial will be
specified in a written annex to this Agreement duly executed by the
Parties. Such annex will be prepared per each
Trial.
|
| 7.2. |
The
parties’ respective rights, obligations and duties under this Agreement
which by their nature extend beyond the expiration or termination
hereof,
shall survive any expiration or termination of this
Agreement.
|
| 8. |
Claims,
Liability And Insurance
|
| 8.1. |
Rosetta
shall bear sole responsibility and bear any payment and/or compensation
and/or liability for any damage whatsoever caused to any person,
directly
or indirectly, as a result of the performance of any of the Trials
or the
Research Project. Provided however that Rosetta shall not be responsible
or liable to pay any payments or compensation that are the result
of a
negligent act or willful misconduct of the Beneficiaries (as such
term is
defined in Section 8.2 below).
|
| 8.2. |
Rosetta
shall bear sole responsibility for any damage caused to any of Rosetta’s
Personnel in the Hospital’s premises, or to any third party by Rosetta’s
Personnel’s acts, omissions or willful
misconduct.
|
| 8.3. |
Rosetta
shall indemnify and hold harmless, THM, the Hospital, the Research
Project
staff, the Investigator and their employees and/or agents and/or
officers
and/or representatives (hereinafter: “The
Beneficiaries”)
from and against all claims, demands, causes of action and suits
of
whatsoever kind or nature based on damages claimed to have been caused
as
a result of the performance of any of the Trials and/or the Research
Project and/or the Study and/or any procedures prescribed in any
Trial
Protocol and/or pertaining to the Research Project and/or from the
performance of Rosetta’s Personnel’s Work and/or from the acts, omissions
or willful misconduct of Rosetta’s Personnel (“the
Loss”);
provided, however, that:
|
| 8.3.1. |
The
Loss was not caused as a result of a negligent act or willful misconduct
of THM and/or the Research Entity and/or the Investigator and/or
their
employees and agents.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 8.3.2. |
The
Loss was not caused as a result of THM’s and/or the Research Entity’s
and/or the Investigator’s failure to perform the relevant Trial in
accordance with the Trial’s
Protocol.
|
| 8.3.3. |
THM
notified Rosetta, within 30 working days from the day THM acquired
such
knowledge, of any claim, or injury relating to the Research
Project.
|
| 8.3.4. |
Rosetta
shall pay all expenses associated with any proceedings taking place
as a
result of a complaint and/or legal claim submitted by any person
in
respect of the Loss.
|
| 8.4. |
Without
derogating from its above liabilities, the Company shall maintain
adequate
and appropriate insurance policies covering their liabilities under
this
Agreement. Such insurance shall include third parties’ liabilities and
employer’s liabilities.
|
| 9. |
Royalties
|
| 9.1. |
The
terms “Net Sales” “License”, “Licensing Consideration” and “Products”
shall have the meaning ascribed to them in subsection 9.9
below.
|
| 9.2. |
In
return for THM’s undertaking under this Agreement, Rosetta shall pay to
THM all the following amounts:
|
| 9.2.1. |
A
royalty of [***]% ([***] percent) of Net Sales by or on behalf of
Rosetta
(“Royalties”).
|
| 9.2.2. |
[***]%
([***] percent) of all Licensing
Consideration.
|
| 9.3. |
In
the event Rosetta is obligated, pursuant to agreements with Research
Institutes, as defined below, to pay THM and other Research Institutes
royalties of Net Sales with respect to a product employing the Patents
and
Additional Patents (the “Combination
product”),
in a total amount exceeding [***]% ([***] percent) of Net Sales,
then
Rosetta shall be entitled to reduce the amount of Royalties payable
to THM
hereunder according to the following principals: (a) Rosetta shall
calculate the total amount of Royalties it is obligated to pay THM
and the
Research Institutes that their Additional Patents are required for
the
sale, manufacture or use of the Combination Product (the “Total
Royalties Amount”);
(b) Rosetta shall calculate the difference between the Total Royalties
Amount and [***]% (the “Difference”);
(c) Rosetta shall calculate the relative share of THM’s Royalties in the
Total Royalties Amount (“THM’s
Royalties Share”)
and (d) Rosetta shall be entitled to reduce THM’s amount of Royalties by
an amount equal to the product of THM’s Royalties Share multiplied by the
Difference. Provided,
however,
that in no event shall THM’s Royalties be reduced to less than
[***]%.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
For
example: if Rosetta will be required to pay to Research Institutes in
consideration for patent rights an amount of [***]%. Then THM’s Royalties Share
shall be [***]% ([***]), and Rosetta shall have the right to reduce THM’s
royalties in an amount of [***]% and it will owe THM [***]% of royalties instead
of [***]%.
In
the
event Rosetta wishes to reduce THM’s Royalties, as specified in this clause 9.3,
Rosetta shall be obligated to provide THM, [***] prior to such reduction, with
a
written report containing the manner in which the reduction was calculated,
including all the details specified in clause 9.3 (a) - 9.3 (d) herein and
in
the above example. Such report shall be executed and confirmed by both,
Rosetta’s Chief Financial Officer and by Rosetta’s external auditor
(accountant).
“Research
Institute”
shall
mean: any entity that shall develop Research Results in collaboration with
or
for Rosetta, or separately from Rosetta, whether prior to the Effective Date
or
during the term of this Agreement, provided that such Research Results are
covered by a patent (“the
Additional Patents”).
For
the removal of doubt it is hereby clarified that “Research Institute” shall not
include manufacturers, producers and or any other service providers except
as
explicitly defined above.
| 9.4. |
The
amounts payable to THM under this clause 9 shall be paid as
follows:
|
| 9.4.1. |
Royalties,
as specified in subsections 9.2.1, shall be paid on a quarterly basis.
Within [***] after the end of each quarter, commencing on the first
quarter where the first commercial sale took place or Licensing
Considerations are paid to Rosetta.
|
| 9.4.2. |
THM’s
fee of Licensing Consideration, as specified in subsection 9.2.2
shall be
paid within [***] from receipt of any Licensing Consideration by
Rosetta
from any Licensee.
|
| 9.5. |
In
calculating Net Sales, Licensing Consideration, all amounts shall
be
expressed in US Dollars and any amount received or invoiced in a
currency
other than US Dollars shall be translated into US Dollars, for the
purposes of calculation, in accordance with the Exchange Rate between
the
US Dollar and such currency on the date of such receipt or invoice,
as the
case may be.
|
| 9.6. |
Rosetta
shall provide THM with the following written reports: (a) a report
specifying the amounts payable to THM from Licensing Consideration.
Such
report shall be provided to THM within [***] after any Licensing
Consideration are received; and (b) a detailed quarterly report,
commencing with the first calendar quarter in which any Net Sales
are
made, or Licensing Consideration received or royalties are received
by
Rosetta, in a form acceptable to THM, signed by the chief financial
officer of Rosetta, specifying all amounts payable to THM under this
clause 8 in respect of the previous quarter to which the report refers.
Such report shall include: (i) the sales made by Rosetta and Licensees
with a breakdown of Net Sales according to country, identity of seller,
currency of sales, dates of invoices, number and type of Products
sold
and; (ii) Licensing Consideration with a breakdown according to identity
of Licensees, countries, the currency of the payment and date of
receipt
thereof; and (iii) deductions applicable, as provided in the definition
of
“Net Sales”; (iv) the Total royalties Amount paid by Rosetta of Net Sales,
and THM’s Royalties Share; and (iv) any other matter required by THM in
order to calculate and/or verify the amounts payable hereunder; and
(c)Within [***] after the end of each fiscal year, Rosetta will provide
THM with a detailed report, certified by its Chairman of the Board
and by
it’s independent auditor, stating all amounts due to THM pursuant to
this
clause 8 in the reported year including relevant Invoices issued
and all
invoices and all payments received by Rosetta with respect to it’s Net
Sales and to the Licensing Consideration as detailed in the quarterly
reports.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 9.7. |
Rosetta
shall keep and shall cause Licensees to keep complete, accurate and
correct books of account and records consistent with sound business
and
accounting principles and
practices.
|
| 9.8. |
THM
shall be entitled to appoint an independent auditor selected by it
to
inspect, during Rosetta’s regular business hours, all equipment, records,
and documents of Rosetta as may contain information bearing upon
the
amounts payable to THM under this clause 8. Rosetta shall take all
steps
necessary so that all such books of account, records and other
documentation of Rosetta and its Licensees are available for inspection
as
aforesaid at a single location for each of Rosetta and its Licensees.
The
cost of such auditing shall be borne by Rosetta if the audit uncovers
an
underreporting of the corresponding amounts owed to THM by more than
[***]
percent ([***]%). Otherwise, such costs and expenses shall be borne
by
THM. Rosetta shall remedy such discrepancy and pay (i) the shortfall
within [***] of the date of discovery; and (ii) interest thereon
at the
rate of [***]% above the London Interbank Offered Rate (LIBOR) applicable
to a 12 month USD deposit, as such rate shall be in effect on each
Disbursement Date. The Interest shall be compounded annually and
computed
on the basis of a 360 day year.
|
| 9.9. |
Definitions:
|
| 9.9.1. |
“Net
Sales”
shall mean the Total amount invoiced by Rosetta with respect to Products
sold anywhere in the world (whether in a territory where one or more
of
the Patents is applicable or not) after deducting (if not previously
deducted from the amount invoiced):
|
| (i) |
customs
duties, VAT or any other sales taxes or levies to the extent applicable
to
the sale or export of Products or Services and not collected separately
from the counterparty to the sale;
|
| (ii) |
Amounts
credited by a credit note.
|
provided
that, with respect to sales which are not at arms-length and/or are not in
the
ordinary course of business and/or are not according to then current market
conditions for such a sale, the term “Net Sales” shall mean the total amount
that would have been due in an arms-length sale made in the ordinary course
of
business and according to the then current market conditions for such sale
or,
in the absence of such current market conditions, according to market conditions
for sale of products similar to the Products, and provided further that, with
respect to sales by Rosetta, to any affiliate, the term, “Net Sales” shall mean
the higher of: (a) “Net Sales”, as defined above, with respect to sales which
are not at arms-length and/or in the ordinary course of business and/or
according to current market conditions; and (b) the total amount invoiced by
such affiliate on resale to an independent third party purchaser after the
deductions specified in subparagraphs (i) and (ii) above, to the extent
applicable;
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
For
the
sake of clarity, Net Sales shall not include amounts received by Rosetta for
research funding.
| 9.9.2. |
This
section was intentionally left
blank.
|
| 9.9.3. |
“Licence”
shall mean any right granted, licence and/or sublicense given, or
agreement entered into, by Rosetta to or with any other person or
entity,
permitting any use of the Research Results and/or any other information
and/or data and/or technologies and/or developments conceived and/or
developed in the course of the Research Project and/or the Patents
(or any
part thereof) for the development and/or manufacture and/or marketing
and/or distribution and/or sale of Products; and the term “Licensee”
shall be construed accordingly;
|
| 9.9.4. |
“Licensing
Consideration”
-
shall mean all royalties, license fees and milestone payments, or
all
other payment, whether monetary or otherwise, received by Rosetta
for or
from the grant of Licences and/or pursuant thereto, or in connection
with
the grant of an option for a Licence. For clarity, Licensing Consideration
will not include equity investments in Rosetta, research funding
paid to
Rosetta or loans provided that such loans were not granted to Rosetta
for
a grant of License;
|
“Research
Results”:
all
and any inventions, products, materials, compounds, compositions, substances,
methods, processes, techniques, know-how, data, information, discoveries and
other results of whatsoever nature discovered or occurring in the course of,
or
arising from, the performance of a research;
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
THM’s
Research
Results”:
Research results discovered or occurring in the course of, or arising from,
the
performance of the Research Project including all Trials.
“Patents”:
all
patent applications or applications for certificates of invention covering
portions of THM’s Research Results and all patents or certificates of invention
which may be granted thereon; as well as all continuations,
continuations-in-part, patents of addition, divisions, renewals, reissues and
extensions of any of the foregoing patents, but excluding patent applications
that have been withdrawn, expired or not accepted, in each case, such exclusion
with effect only from the date of such invalidation, cancellation, withdrawal
or
expiry, as the case may be.
| 9.9.5. |
“Products”
-
any products, the development, design, manufacture, sale or use of
which
is based upon and/or uses and/or employs one or more Patents and/or
THM’s
Research Results covered by a Patent, provided however that if a
certain
Patent was not approved, then any product including THM’s Research Results
that were part of such not approved Patent, will be considered a
Product
as well.
|
| 10. |
Miscellaneous.
|
| 10.1. |
Assignment.
No party to this Agreement shall be entitled to transfer or assign
its
rights or obligations under this Agreement, unless with the prior
written
consent of the other party, which shall not be unreasonably withheld;
provided however that an assignment resulting from merger and/or
acquisition of either party shall not require the consent of the
other
party, in the event that the surviving entity is committed to such
assigning party’s obligations hereunder. Notwithstanding the
aforementioned, THM shall be entitled to assign it’s rights and
obligations hereunder to any legal entity which was established in
connection with or for the benefit of the
Hospital.
|
| 10.2. |
No
Agency.
It is hereby expressly declared and agreed that this Agreement in
no way
establishes any principal-agent, employer-employee, or partnership
relations between the parties. Nothing in this Agreement shall be
construed as granting either party the power or authority to act
for or on
behalf of the other party, to create any undertakings on behalf of
the
other party, or to bind or commit the other party in respect to any
such
undertakings, except as set forth herein or as otherwise agreed to
in
writing between the parties prior to such
act.
|
| 10.3. |
Governing
Law; Venue.
This Agreement shall be governed by and construed in accordance with
the
laws of the State of Israel. The competent courts of Tel Aviv shall
have
the exclusive jurisdiction to adjudicate on any disputes arising
hereunder.
|
| 10.4. |
Entire
Agreement.
This Agreement, including all exhibits attached hereto, constitutes
the
entire understanding of the parties and supersedes all oral or written
representations, agreements and understandings between the parties
with
respect to the subject matter hereof, all of which shall become,
upon
signature of this Agreement, void.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| 10.5. |
Amendments;
Interpretation.
No modification or amendment of this Agreement may be made except
in a
written instrument duly signed by all parties. The headings in this
Agreement are inserted for convenience of reference only and shall
not
affect its interpretation. The preamble and annexes to this Agreement
form
an integral part of this Agreement.
|
| 10.6. |
Severability.
If any non-material condition, term or covenant of this Agreement
shall at
any time be held to be void, invalid or unenforceable such condition,
covenant or term shall be construed as severable and such holding
shall
attach only to such condition, covenant or term and shall not in
any way
affect or render void, invalid or unenforceable any other condition,
covenant or term of this Agreement, and this Agreement shall be carried
out as if such void, invalid or unenforceable term were not embodied
herein.
|
| 10.7. |
Waivers.
The failure at any time of either Party to enforce any of the terms
or
conditions or any right or to exercise any option of this Agreement
will
in no way be construed to be a waiver of such terms, conditions,
rights or
options, or in any way to affect the validity of this Agreement.
A waiver
by a party of any of its rights under this Agreement shall not be
effective unless made by a written instrument duly signed by such
party,
and shall not be deemed a waiver of any other right
hereunder.
|
| 10.8. |
No
Hiring.
Both Parties acknowledge that each Party would receive substantial
additional value and would be deprived of the benefits of its work
force,
if the other Party were to hire such Party’s personnel after such Party’s
introduction of them to the other Party. Accordingly, each Party
shall
not, directly or indirectly, recruit or hire or engage any personnel
of
the other Party that are or have been assigned to perform any of
the
services and/or Research Project or any part thereof hereunder, or
induce
such personnel to quit employment with the other Party, during the
term of
this Agreement and for a period of [***] following the termination
of this
Agreement, without the other Party’s prior written
consent..
|
| 10.9. |
Notices.
Any notice sent by one party to the others to the addresses set forth
below shall be considered as having reached its destination, if it
was
delivered by hand, at the time of its delivery; if it was sent by
registered mail, within 96 hours from the time it was so dispatched;
and
if it was sent by facsimile, within 48 hours from the receipt of
the
confirmation of proper transmission of the
notice.
|
|
If
to Rosetta:
|
▇▇
▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇▇
Fax:
▇▇▇-▇-▇▇▇▇▇▇▇
Attention:
Director, Business Development
|
|
If
to THM:
|
Tel
Hashomer Ltd.
The
Technology Transfer Company of
Claim
Sheba Medical Center, Tel Hashomer, 5621 Israel
Office:
▇▇▇▇ ▇ ▇▇▇▇▇▇▇
Fax:
▇▇▇▇ ▇ ▇▇▇▇▇▇▇ Attention: Business Development
|
IN
WITNESS WHEREOF, the parties have set their signatures hereunto as of the date
first above written.
|
|
|
|
By:
/s/ ▇▇▇▇ ▇▇▇▇▇▇
|
By:
/s/ ▇▇▇▇▇▇ Nos
|
|
Name:
▇▇▇▇ ▇▇▇▇▇▇
|
Name:
▇▇▇▇▇▇ Nos
|
|
Title:
President and CEO
|
Title:
Chairman
|
I,
▇▇▇▇.
▇▇▇▇▇▇ Rechavi as THM Researcher in this Agreement, acknowledge that I have
read
this Agreement in its entirety and that I shall uphold my individual obligations
and responsibilities set forth herein.
/s/
Gideon
Rechavi
▇▇▇▇.
▇▇▇▇▇▇ Rechavi
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Appendix
A
Research
Plan for Lung Cancer Project: Sheba Medical center - Rosetta Genomics
Ltd.
May
16th,
2006
Project
Goal:
Develop
a
[***]. The study will use a [***] and [***] of [***] that are [***] of human
lung cancer.
Project
Sub-goals:
| 1. |
[***]
|
|
2.
|
Perform
the [***].
|
Stage
1:
|
Step
|
Details
|
Suggested
Responsible Party
|
Estimated
Completion Time
|
|
I. Pre-discovery:
|
Obtain
[***]. In order to [***].
|
[***]
|
[***]
|
|
Identify
[***]. This step will [***].
|
[***]
|
[***]
|
|
|
II. Discovery:
|
Obtain
[***]. The [***].
|
[***]
|
[***]
|
|
Perform
[***].
|
[***]
|
[***]
|
|
|
Analyze
[***] in order to [***].
|
[***]
|
||
|
Based
on [***].
|
[***]
|
[***]
|
Stage
2:
Steps
1-3
will apply to [***] availability and on [***]. Rosetta will [***] Sheba for
this
purpose [***]. Following this, Sheba will [***] Rosetta [***], as will be
determined by both parties. Rosetta will[***].
[***]
will be [***] as soon as Sheba’s [***] will be [***].
General
guideline:
[***]
will be [***] in the Rosetta Genomics’ [***].
In
order
to [***] Rosetta Genomics will [***]Sheba will [***].
Budget
for the Lung Cancer project:
|
Technician
[***]
|
$[***]
|
|
Research
Coordinator
|
$[***]
|
|
Kits,
reagents, disposables
|
$[***]
|
|
Overhead
[***]%
|
$[***]
|
|
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 406 of the Securities Act.