Research Collaboration Agreement
This
agreement (this “Agreement”)
is
made and entered into as of the 22 day of June, 2006 (the “Effective
Date”)
by and
between Rosetta
Genomics Ltd.,
a
private company registered pursuant to the laws of the State of Israel, of
00
Xxxxx Xxxxxx, Xxxxxxx Xxxx, Xxxxxxx, Xxxxxx (“Rosetta”)
and
Hadasit
Medical Research Services and Development Ltd., a
private
company registered under the laws of the state of Israel, of Hadassah Medical
Xxxxxxxx, XXX 00000, Xxxxxxxxx, Xxxxxx (“Hadasit”).
WHEREAS,
Hadasit is a subsidiary of Hadassah Medical Organization (“HMO”)
and is
charged with the commercial exploitation of the intellectual property and other
potentially valuable assets of HMO; and
WHEREAS,
Rosetta, Hadasit and HMO desire to collaborate in a research projects according
to the protocols described in Appendix A (which will be updated by the Parties
on mutual consent), pursuant to which HMO will provide Rosetta with its clinical
know how, data and expertise, patients’ specimens (“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 and therapeutic
application (the “Research
Project”);
and
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:
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1.1 |
“Affiliate”
of a Party or other entity shall mean any entity that, directly or
indirectly, is controlled by, controls, or is under common control
with
such Party including (i) any corporation or business entity of which
at
least fifty percent (50%) or the maximum ownership interest permitted
by
applicable law in the country where such entity exists, whichever
is less,
of the securities or other ownership interests representing the equity
or
right to receive profits, the voting stock, general partnership interest
or power to direct the affairs of such entity, are owned, controlled
or
held, directly or indirectly, by a Party
or
such entity;
(ii) any corporation or business entity which, directly or indirectly,
owns, controls or holds at least fifty percent (50%) or the maximum
ownership interest permitted by law in the country where a Party
or such
entity exists, whichever is less, of the securities or other ownership
interests representing the equity or right to receive profits, voting
stock, general partnership interest or power to direct the affairs
of, a
Party or such entity; or (iii) any corporation or business entity
of which
a Party or such entity has the right to acquire, directly or indirectly,
at least fifty percent (50%) or the maximum ownership interest permitted
by law in the country where such entity exists, whichever is less,
of the
securities or other ownership interests representing the equity or
right
to receive profits, voting stock, general partnership interest or
power to
direct the affairs, thereof.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.2 |
“Combination
Product”
shall mean a product, substance or device which is not an internal
development of Rosetta derived from the Research Results, and which
incorporates a product based on the Patent Assets and at least one
other
essential additional ingredient, substance, compound or element which
either (i) when administered to a patient, has a therapeutic or
prophylactic clinical effect, either directly or by acting synergistically
with other compounds or substances contained in such product, (ii)
is
required for delivery of another compound or substance contained
in such
product or (iii) otherwise enhances the effect another compound or
substance contained in such
product.
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1.3 |
“Customers”
shall mean patients, hospitals, medical institutions, health funds,
pharmacies and other retailers, provided that they are not an Affiliate
of
Rosetta Genomics.
|
1.4 |
“First
Commercial Sale”
shall mean the first for-profit sale of a Product or a Service by
Rosetta
Genomics or its Affiliates in any country in the Territory, for end
use or
consumption; provided, that, any sale to an Affiliate or Sublicensee
will
not constitute a First Commercial Sale unless the Affiliate or Sublicensee
is the last entity in the distribution chain of the Product or
Service.
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1.5 |
“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.
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1.6 |
“Net
Sales”
shall mean the aggregate gross amount invoiced with respect to Products
sold or provided in the Territory, by Rosetta or its Affiliates to
Customers, after deducting (if not previously deducted from the amount
invoiced):
|
(i) |
quantity
and/or cash discounts directly related to the sale of the Product;
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(ii) |
customs
duties, VAT or any other sales taxes or levies to the extent applicable
to
the sale or export of Products or Services and not collected separately
from the counterparty to the sale;
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(iii)
|
recalls,
credits and allowances on account of returned or rejected products,
including, but not limited to, allowance for breakage or
spoilage;
|
(iv) |
payments
paid in connection with transporting, packaging and insuring the
Products
and appearing separately on invoices; and
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(v) |
amounts
not actually collected;
|
provided
however that:
(i) |
In
any transactions between Rosetta and an Affiliate, Net Sales shall
be
[***], in each case, after appropriate deductions as set forth
above;
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(ii) |
In
the event that Rosetta or its Affiliate receives non-monetary
consideration for any transaction, Net Sales shall be calculated
based on
the fair market value of such consideration, except that with respect
to
Net Sales received in the form of equity,
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(iii) |
In
the event a Product is sold by Rosetta, or an Affiliate of Rosetta
in the
form of a Combination Product, Net Sales from such Combination Product,
for purposes of determining Royalties, shall be determined by multiplying
the actual Net Sales of such Combination Product during the applicable
royalty reporting period, by the fraction [***]. In the event that
such
average sale price cannot be determined for both the product based
on the
Patent Rights and all other ingredients, substances, compounds or
elements
included in the Combination Product, Net Sales for the purpose of
determining royalties shall be calculated by multiplying the Net
Sales of
the Combination Products by the fraction [***]. In such event, the
parties
shall negotiate in good faith to arrive at a determination of the
respective fair market values of the product based on the Patent
Assets
and all other additional ingredients included in the Combination
Product.
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For
the
sake of clarity, Net Sales shall not include amounts received by Rosetta as
grants or other research funding, but shall include, in addition to amounts
received for sale of Collaboration Products by Rosetta or its Affiliates as
described above, revenues received as consideration for a sublicense of the
rights to commercialize a Product.
1.7 |
“Patent
Rights”
shall mean United States and foreign patents and patent applications
(which shall be deemed to include certificates of invention and
applications for certificates of invention) which as of the Effective
Date
or at any time during the term of this Agreement relate in any way
to
Research Results, including all certificates of invention, divisions,
continuations, continuations-in-part, reissues, renewals, extensions,
supplementary protection certificates or the like of any such patents
and
current and future patent applications, and any counterparts thereof
which
may be filed in other countries. Any Patent Rights and any subsequent
changes thereto shall be attached hereto as Schedule 1.7, provided,
however, that the failure to include the then current Patent Rights
in
Schedule 1.7 from time to time shall not affect the Parties’ respective
rights and obligations under this Agreement.
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1.8 |
“Products”
-
any products developed and/or manufactured based upon and/or in connection
with the Patent Rights.
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1.9 |
“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.
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1.10 |
“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.
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1.11 |
“Rosetta
MicroRNAs”
shall mean any novel human and non-human (including virus and bacteria)
microRNAs predicted or which may be predicted by
Rosetta.
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1.12 |
“Sub
License”
-
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 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;
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.13 |
“Sublicense
Income”
shall mean all royalties, license fees and milestone payments paid
by a
Sublicensee to Rosetta in consideration of the grant of a Sublicense
to
such Sublicensee. [***].
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1.14 |
“Sub
Licensee”
shall mean a sublicensee who was granted a Sublicense from Rosetta
Genomics.
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1.15 |
“Territory”
shall mean all the countries in the
world.
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1.16 |
“Valid
Claim”
means a claim of an issued and unexpired patent included within the
Patent
Rights, which has not been revoked or held unenforceable or invalid
by a
decision of a court or other governmental agency of competent
jurisdiction, unappealable or for which an appeal has not been filed
within the time allowed for appeal, and which has not been disclaimed,
denied or admitted to be invalid or unenforceable through reissue
or
disclaimer or otherwise.
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2.1 |
The
parties will collaborate in the performance of the Research Project,
pursuant to the following terms and
conditions:
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2.2 |
The
Research Project shall include multiple trials as agreed upon by
the
Parties (the Trials”), each Trial shall be performed in accordance with a
protocol to be prepared by the company for each Trial and agreed
upon by
Hadasit (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 advisory services provided during
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 Xxxxxxxx
X0,
X0 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.
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2.3 |
The
first Trials shall be conducted according to the Protocol attached
to this
Agreement as Appendix A1 Appendix A2, and constituting an integral
part
thereof ("Protocol A1" and “Protocol A2”). Hadasit, HMO and Rosetta shall
perform the activities mentioned in Protocol A1 and Protocol A2.
Hadasit
shall procure the performance of the the activities designated to
it in
Protocol A1 and in any other Protocol, by
HMO.
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2.4 |
Rosetta
shall oversee the conduct of the Research Project. Hadasit shall
designate
a senior researcher for each Protocol. (the “Investigator”) to collaborate
with Rosetta in carrying out HMO’s activities related to the Research
Project.
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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.
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2.6 |
Each
party represents and warrants that it is legally authorized and entitled
to assume all responsibilities under this
Agreement.
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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
HMO’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.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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; and (3) 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. Rosetta shall
use the
Study Specimens solely for the purpose of the Study and not for any
other
purposes whatsoever.
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2.9 |
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.
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2.10 |
Rosetta
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 Fund for examination, upon the Fund’s request.
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2.11 |
Notwithstanding
the above, nothing contained herein shall be construed as a warranty
by
Hadasit and/or the HMO and/or any other party involved in the Research
Project, that the Research Results will be useful or commercially
exploitable or of any value whatsoever. In addition, and without
derogating from the aforementioned, the above parties disclaim all
warranties, either express or implied, with respect to any products
that
incorporate, integrate or are designed based in whole or part, on
the
Research Results (“New
Products”),
including without limitation implied warranties of merchantability,
efficacy and fitness for a particular purpose.
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3 |
Permitted
Uses of Information, Rights to the Research Results and Intellectual
Property.
|
3.1 |
Hadasit
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
Section 5, Hadasit may publish the information in accordance with
Section 6 below.
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3.2 |
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 jointly owned by
and vest
with both Hadasit and Rosetta.
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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.
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4 |
4.1 |
Filing,
Prosecution and Maintenance of Patent Applications or
Patents
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4.1.1 |
Patent
Rights.
Rosetta, acting through patent counsel of its choice, shall be
responsible, at its sole expense, for the preparation, filing, prosecution
and maintenance of all Patent Rights in Rosetta’s and Hadasit’s name. At
Rosetta’s request, Hadasit shall cooperate with Rosetta in all reasonable
respects in connection with such preparation, filing, prosecution
and
maintenance of Patent Rights.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
4.1.2 |
Review
of Patent Applications.
In
each case, the Rosetta shall give Hadasit an opportunity to review
the
text of the application before filing, shall consult with Hadasit
with
respect thereto, and shall supply Hadasit with a copy of the application
as filed, together with notice of its filing date and serial number.
Rosetta shall keep Hadasit advised of the status of the actual and
prospective patent application filings and upon the request of Hadasit,
shall provide advance copies of any papers related to the filing,
prosecution, or maintenance of such patent application filings.
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4.1.3 |
Right
of Hadasit to Prosecute and Maintain Patents.
Rosetta shall give notice to Hadasit of any desire to cease prosecution
and/or maintenance of the Patent Rights and, in such case, shall
permit
Hadasit, at its sole discretion, to continue prosecution and/or
maintenance at its own expense. In the event that Hadasit continues
prosecution and/or maintenance at its own expense, Rosetta shall
have no
rights to any such patent/patent application and any license granted
to it
for such patent/patent application shall terminate. Provided however
that
in the event that Roestta’s notice of its desire to cease prosecution
and/or maintenance related to certain Patent Rights and/or certain
countries, then the license shall terminate only with regard to those
patent rights and/or in those countries.
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4.2 |
Patent
Office Proceedings.
Hadasit shall reasonably cooperate with Rosetta with respect to any
patent
office proceeding.
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4.3.1 |
Each
Party shall promptly give the other Party notice of any infringement
in
the Territory of any patent application or patent included in the
Patent
Rights that comes to such Party’s attention. The Parties will thereafter
consult and cooperate fully to determine a course of action, including,
without limitation, the commencement of legal action by either Party.
Rosetta, upon notice to Hadasit, shall have the first right to initiate
and prosecute such legal action at its own expense and in the name
of
Hadasit and Rosetta, as applicable, or to control the defense of
any
declaratory judgment action relating to the Patent Rights. Rosetta
shall
promptly inform Hadasit if Rosetta elects not to exercise such first
right, and Hadasit thereafter shall have the right, in its discretion,
to
initiate and prosecute such action or to control the defense of such
declaratory judgment action (“Manage Proceedings”) in the name of Hadasit
and Rosetta. In the event that Rosetta elects not to Manage Proceedings
and Hadasit elects to Manage Proceedings, Rosetta shall have no rights
to
any such patent/patent application and any license granted to it
for such
patent/patent application shall terminate. Provided however that
in the
event elected not to Manage Proceedings only with regard to certain
patent
applications and/or certain countries, and Hadasit Managed Proceedings
for
such patent applications and/or in such countries, then the license
will
terminate only with regard to those patent assets and/or in these
countries. In no event shall Rosetta enter into any settlement that
would
adversely affect the Patent Rights in any material respect without
the
prior written consent of Hadasit.
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4.3.2 |
For
any such legal action or defense, in the event that any Party is
unable to
initiate, prosecute, or defend such action solely in its own name,
the
other Party shall join such action voluntarily and shall execute
all
documents reasonably necessary for the Party to prosecute, defend
and
maintain such action. In connection with any such action, the Parties
will
cooperate and will provide each other with any information or assistance
that either reasonably may request. Each Party shall keep the other
informed of developments in any such action or proceeding, including,
to
the extent permissible by law, the status of any settlement negotiations
and the terms of any offer related thereto.
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4.3.3 |
Any
recovery obtained by Rosetta or Hadasit in any such action or proceeding
shall be shared as follows in the following order of
priority:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
4.3.3.1 |
the
Party that initiated and prosecuted or maintained the defense of,
the
action, shall recoup all of its costs and expenses incurred in connection
with the action, whether by settlement or
otherwise;
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4.3.3.2 |
the
other Party shall next recoup all of its costs and expenses incurred
in
connection with the action, whether by settlement or
otherwise;
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4.3.3.3 |
if
Hadasit initiated and prosecuted, or maintained the defense of, the
action, the amount of any recovery remaining then shall be retained
by
Hadasit; and
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4.3.3.4 |
if
Rosetta initiated and prosecuted, or maintained the defense of, the
action, the amount of any recovery remaining shall be retained by
Rosetta,
except that Hadasit shall receive a portion equivalent to the royalties
they would have received on such remaining amount if such amount
were
deemed Net Sales.
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4.4 |
Patent
Term Extensions and Supplemental Protection Certificates.
The Parties shall cooperate in obtaining patent term extensions or
supplemental protection certificates or their equivalents in any
country
in the Territory where applicable and where desired by Rosetta. If
elections with respect to obtaining such extension or supplemental
protection certificates are to be made, Rosetta shall have the first
right
to make the election, in consultation with
Hadasit.
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6 |
Rosetta
agrees to bear the advisory 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 two Trials
specified in Protocol A1 and Protocol A2, is attached as Appendix
B1 and
Appendix B2.
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7.1 |
Non-Disclosure
and Non-Use Obligations
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7.2 |
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:
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7.2.1 |
is
known by the receiving Party (including the HMO in the case of Hadasit)
at
the time of its receipt, and not through a prior disclosure by the
disclosing Party, as documented by contemporaneous written
records;
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7.2.2 |
is
in the public domain or knowledge;
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7.2.3 |
is
subsequently disclosed to a receiving Party (including the HMO in
the case
of Hadasit) by a Third Party who may lawfully do so and is not under
an
obligation of confidentiality to the disclosing Party;
or
|
7.2.4 |
is
developed by the receiving Party (including the HMO in the case of
Hadasit) 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.
7.4 |
Notwithstanding
Section 7.1, a Party receiving Proprietary Information of another
Party may disclose such Proprietary
Information:
|
7.4.1 |
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;
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7.4.2 |
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; or
|
7.4.3 |
if
required to be disclosed by law or court order, provided that notice
is
promptly delivered to the disclosing Party in order to provide an
opportunity to challenge or limit the disclosure obligations; provided,
however,
without limiting any of the foregoing, it is understood that either
Party
or its Affiliates may make disclosure of this Agreement and the terms
hereof in any filings required by the SEC, may file this Agreement
as an
exhibit to any filing with the SEC and may distribute any such filing
in
the ordinary course of its business. However, to the maximum extent
allowable by SEC rules and regulations, the Parties shall be obligated
to
maintain the confidentiality obligations set forth herein and shall
redact
any confidential information set forth in such
filings.
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7.5 |
Publication.
During the term of this Agreement, Hadasit and Rosetta Genomics each
acknowledge the other Party's interest in publishing its results
related
to the Products to obtain recognition within the scientific community
and
to advance the state of scientific knowledge. Each Party also recognizes
the mutual interest in obtaining valid patent protection and in protecting
business interests and trade secret information. Consequently, either
Party, its employees or consultants wishing to make a publication
shall
deliver to the other Party a copy of the proposed written publication
or
an outline of the proposed oral disclosure at least sixty (60) days
prior
to submission for publication or presentation. The other Party shall
have
the right (a) to propose modifications to the publication for scientific
reason, patent reasons, trade secret reasons or business reasons
or (b) to
request a reasonable delay in publication or presentation in order
to
protect patentable information. If the other Party requests a delay,
the
publishing Party shall delay submission or presentation for a period
of
thirty (30) days to enable patent applications protecting each Party's
rights in such information to be filed. Upon expiration of such thirty
(30) days, the publishing Party shall be free to proceed with the
publication or presentation, but may not include Proprietary Information
of the other Party unless it is within an exception of Section 7.1.1
through 7.1.4. If the other Party requests modifications to the
publication, the publishing Party shall edit such publication to
prevent
disclosure of trade secret or Proprietary Information prior to submission
of the publication or presentation.
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7.6 |
Notwithstanding
anything to the contrary herein, Rosetta shall not use the names
and/or
logos of Hadasit and/or the HMO, and shall not disclose their involvement
in the Research without both their prior written approval, all except
for
(a) references to scientific publications which are already in the
public
domain at the time of executing this Agreement and (b) applications
for
regulatory approvals to official authorities, including securities
authorities, and (c) as requested by regulatory authorities as required
by
law or applicable regulation. Subject to the foregoing, Rosetta shall
include appropriate acknowledgement and credit to Hadasit and/or
the HMO
and their employees in any publication relating to the Research in
whatever media, including application(s) to official authorities
or
presentations to potential
investors.
|
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.
8.1 |
Each
Trial may be terminated according to the termination section provided
in
each Protocol related to such Trial.
|
8.2 |
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.
|
9.1 |
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 Hadasit, HMO or the Investigator.
|
9.2 |
Rosetta
shall indemnify and hold harmless, Hadasit, HMO, the Investigators
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 the commercialization of the New Products (“the Loss”); provided,
however, that:
|
9.2.1 |
The
Loss was not caused as a result of negligence or willful misconduct
of
Hadasit, HMO and/or the Investigator and/or their employees and
agents.
|
9.2.2 |
The
Loss was not caused as a result of Hadasit’s and/or HMO’s and/or the
Investigator's failure to perform the relevant Trial in accordance
with
the Trial's Protocol.
|
9.2.3 |
Hadasit
notified Rosetta, within 30 working days from the day Hadasit acquired
such knowledge, of any claim, or injury relating to the Research
Project.
|
9.2.4 |
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.
|
9.3 |
Without
derogating from its above liabilities, Rosetta shall cover the
beneficiaries with an insurance policy, for an amount similar to
the
amount with which the State of Israel insures its physicians, against
third party’s claims and/or
demands.
|
9.4 |
Neither
party shall be liable (whether under contract, tort (including negligence)
or otherwise) to the other party, or any third party for any indirect,
incidental or consequential damages, including, without limitation,
any
loss or damage to business earnings, lost profits or goodwill and
lost or
damaged data or documentation, suffered by any person, arising from
and/or
related with and/or connected to this agreement even if such party
is
advised of the possibility of such
damages.
|
10 |
Hadasit
hereby grants to Rosetta the sole and exclusive worldwide license, even as
to
HMO
and
Hadasit,
under its part in the Research Results and the and Patent Rights, including
the
right to grant sublicenses on the terms set forth herein, to research, develop,
use, import, offer for sale, market, commercialize, manufacture, distribute
and
sell the Products in the Territory.
11 |
Royalties
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11.1 |
Subject
to the terms and conditions of this Agreement, and in consideration
of the
rights granted by Hadasit hereinabove, Rosetta Genomics shall pay
to
Hadasit royalties in an amount equal to the following percentages
of
aggregate annual Net Sales of any Product in the Territory in each
Royalty
Year a royalty of [***]% ([***] percent) of Net Sales by or on behalf
of
Rosetta.
|
11.2 |
In
the event Rosetta is obligated, pursuant to agreements with third
parties,
to pay Hadasit and such other third parties royalties with respect
to a
Product, in a total amount exceeding [***]% ([***] percent) of Net
Sales,
then Rosetta shall be entitled to reduce the amount of royalties
payable
to Hadasit hereunder according to the following principals: (a) Rosetta
shall calculate the total amount of royalties it is obligated to
pay
Rosetta and the other third parties (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 Hadasit’s royalties from the Total Royalties Amount ("Hadasit
Royalties Share") and (d) Rosetta shall be entitled to reduce Hadasit’s
amount of Royalties by an amount equal to the product of Hadasit’s
Royalties Share multiplied by the Difference. Provided, however,
that in
no event shall Hadasit’s Royalties be reduced to less than
[***]%.
|
For
example: if Rosetta will be required to pay royalties with respect to a Product
an amount of [***]%. Then The difference shall be [***]%, and Hadasit’s
Royalties Share shall be, [***] and Rosetta shall have the right to reduce
Hadasit’s royalties in an amount of [***]% and it will the owe Hadasit [***]% of
royalties instead of [***]%.
11.3 |
If
a Product contains or is designed to detect both micro
RNA sequences covered by a Valid Claim of the Patent Rights and micro
RNA
sequences that are not covered by a Valid Claim of the Patent Rights,
then
Net Sales of such Product shall be multiplied by the ratio of (x)
the
number of micro RNA sequences covered by a Valid Claim of the Patent
Rights in a given Product to (y) the total number of micro RNA sequences
included in such given Licensed Product to determine the portion
of the
value of the micro RNA sequences
Product.
|
11.4 |
Royalties
on Net Sales, at the rates set forth above, shall accrue as of the
date of
the applicable First Commercial Sale in any country and shall continue
and
accrue on Net Sales (a) in a country where a Valid Claim included
within
the Patent Rights exists, until the later of the date of expiry of
such
patent in such country or the expiry of the period of [***] ([***])
years
commencing with the date of the First Commercial Sale (b) in any
other
country, until the expiry of the period of [***] ([***]) years commencing
with First Commercial Sale in such
country.
|
11.5 |
Following
the expiration of the last applicable period set forth in subsection
(v)
above, (a) Rosetta Genomics shall have the right under this Agreement
to
directly and indirectly (through sublicensees or otherwise) continue
to
manufacture, use, market, commercialize, distribute and sell and
otherwise
dispose of Products, throughout the world, without having to pay
royalties
or any other consideration to Hadasit and (b) Hadasit shall not grant
any
exclusive license to its part in the Research Results and/or the
Patent
Rights to any Third Party for the
Field.
|
11.6 |
Sublicense
Income.
Rosetta Genomics will pay Hadasit the following percentages of all
Sublicense Income received from Sublicensees in each Calendar
Quarter:
|
11.6.1 |
[***]%
of Sublicense Income if Sublicense was granted within [***] as of
the
Effective Date.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11.6.2 |
[***]%
of Sublicense Income if Sublicense was granted during the period
between
[***] as of the Effective Date.
|
11.6.3 |
[***]%
of Sublicense Income if Sublicense was granted during at any date
after
[***] as of the Effective Date.
|
11.7 |
Reports;
Payment of Royalty.
Commencing with the first Calendar Quarter in which royalty or other
payments are due, Rosetta shall furnish to Hadasit a quarterly written
report for such Calendar Quarter (the “Quarterly Report”), each showing
the sales of all Products subject to royalty or other payments sold
by
Rosetta Genomics and its Affiliates and all Sublicense Income received
during the reporting period and the royalties or other payments payable
under this Agreement. Quarterly Reports shall be due on the sixtieth
(60th) day following the close of each Calendar Quarter. Royalties
and
other payments shown to have accrued by each Quarterly Report, if
any,
shall be due and payable on the date such Quarterly Report is due.
Rosetta
shall keep (and shall require its Affiliates to keep) complete and
accurate records in sufficient detail to enable Net Sales and the
royalties and other payments payable hereunder, to be determined,
reconciled and verified.
|
11.8 |
Audits.
|
11.8.1 |
Upon
the written request of Hadasit and not more than once in each Calendar
Year, Rosetta shall permit an independent certified public accounting
firm
of recognized standing in Israel, selected by Hadasit and reasonably
acceptable to Rosetta, to have access during normal business hours
at
times mutually convenient to the Parties and upon reasonable notice
to
Rosetta to such of the records of Rosetta as may be reasonably necessary
to verify the accuracy of the royalty and other payment reports hereunder
for any Royalty Year, for a period of up to three (3) years from
the
completion of such Royalty Year. The accounting firm shall report
to
Hadasit only the results of the work performed as contemplated by
this
Section 11.7.1 and the details concerning any
discrepancies.
|
11.8.2 |
If
such accounting firm concludes that additional royalties or other
payments
were owed during such Royalty Year , Rosetta shall pay the additional
royalties or other payments (plus accrued interest at the LIBOR rate
as in
effect on the date that such payment was first due, plus one and
[***]%)
percent) within [***] of the date Hadasit delivers to Rosetta such
accounting firm’s written report so concluding. In the event such
accounting firm concludes that Rosetta overpaid amounts during such
period, Hadasit shall reimburse Rosetta the amount of such overpayment
within [***] of receipt of such accounting firm’s written report. The fees
charged by such accounting firm shall be paid by
Hadasit.
|
11.8.3 |
Each
Party reviewing information under this Section 11.7 shall treat all
financial information subject to review under this Section 11.7 in
accordance with the confidentiality provisions of this Agreement
and shall
request a confidentiality agreement to the same effect from any accounting
firm reviewing information under this Section 11.7.
|
11.9 |
Payments.
All payments to be made under this Agreement shall be made in New
Israeli
Shekels and shall be paid by bank wire transfer or by automated
clearinghouse (electronic funds transfer) in immediately available
funds
to such bank account designated in writing by each Party to the other
from
time to time. Bank charges necessary for making the bank transfer
shall be
incurred by the Party making the
transfer.
|
11.10 |
Save
for the circumstances set out in section 11.8.2 above, any amount
payable
hereunder which has not been made upon its due date of payment, shall
bear
interest from the date such payment is due until the date of its
actual
payment, at the maximum interest charged by Bank Leumi Le Israel
B.M. for
unapproved overdrafts.
|
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.
12 |
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
If
to Rosetta:
|
00
Xxxxx Xxxxxx, Xxxxxxx, 00000, Xxxxxx
Fax:
000-0-0000000
Attention:
Business Development
With
a copy to General Counsel
|
If
to Hadasit:
|
POB
12000, Xxxxxxxxx 00000, Xxxxxx
Fax:
+972-2- 6437712
Attention:
VP Finance and Contracts
With
a copy to Legal Counsel
|
By:
Name:
Title:
|
_____________________________________
By:
Name:
Title:
|
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.