RESEARCH AND LICENSE AGREEMENT (HVC)
(HVC)
This
agreement (the "Agreement")
is
made and entered into as of the 30 day of May, 2005 (the "Effective
Date")
by and
between Rosetta
Genomics Ltd.,
a
private company registered under the laws of the State of Israel, of ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ("Rosetta")
and
Hadasit
Medical Research Services and Development Ltd.,
a
private company registered under the laws of the state of Israel, of Hadassah
Medical ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ("Hadasit").
WHEREAS,
Rosetta is engaged in research and development in the field of bioinformatics
and molecular biology detection, prediction and discovery of MicroRNA sequences
and their respective functions and utilities, and therapeutic and diagnostic
uses based thereon, in the course of which Rosetta has discovered and filed
patents for a large number of MircoRNAs and their respective functions and
utilities; and
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,
Prof. Eithan Galum (the "Principal
Investigator")
from
the ▇▇▇▇▇▇▇ ▇▇▇▇▇ Institute of Gene Therapy at the Hadassah Hebrew University
Hospital ("HUH")
has
expertise in the field of viral infection of HVC research; and
WHEREAS,
Rosetta and Hadasit have previously negotiated a Principles of a Joint Research
Agreement (the "Joint
Research Memorandum"),
which
defines the main principles pursuant to which Rosetta and the Principal
Investigator will collaborate in the performance of certain Research (as defined
below) relating to the suppression of viral activity of HCV by using MicroRNAs;
and
Suppress
viral infection of HCV by using HCV and human MicroRNAs over expression or
silencing. Show results on animal model.
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 and the future
utilization of its results, which terms will supersede and replace the Joint
Research Memorandum;
NOW
THEREFORE, the parties, intending to be legally bound, hereby agree as
follows:
1.
Interpretation
1.1 In
this
Agreement, each of the following terms shall have the meaning set forth opposite
it, unless the context otherwise requires:
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.
1.1.1 "Affiliate"
shall
mean, with respect to a party, any person, organization or entity controlling,
controlled by or under common control with, such party. For purposes of this
definition only, "control" of another person, organization or entity shall
mean
the possession, directly or indirectly, of the power to direct or cause the
direction of the activities, management or policies of such person, organization
or entity, whether through the ownership of voting securities, by contract
or
otherwise.
1.1.2 "Combination
Product"
shall
mean a product, substance or device which is not an internal development of
Rosetta derived from the Results under this Agreement, and which incorporates
a
product based on the Results or Joint Patents 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.
1.1.3 "Field"
shall
mean the field of MicroRNA based therapeutic related to HCV.
1.1.4 "Hadasit
IP"
shall
mean any and all Intellectual Property that Hadasit has developed or will
develop, or which Hadasit owns or will otherwise own, excluding the
Results.
1.1.5 "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, moral rights, drawings, trade marks, 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.
1.1.6 "Joint
Patents"
shall
mean any joint patent or patent application relating to the
Results.
1.1.7 "License"
shall
mean the license granted under Section 7 below.
1.1.8 "Licensed
IP"
shall
mean the Results, the Joint Patents and any other Intellectual Property
underlying the results.
1.1.9 "Net
Revenues"
shall
mean the gross amount received by or on behalf of Rosetta or its Affiliates
in
connection with the commercialization of the Results or Joint Patents, less
the
following: (a) credits, refunds, rebates or trade, quantity, or cash discounts
to the extent actually allowed and taken; (b) amounts repaid or credited by
reason or rejection or return; (c) any taxes or other governmental charges
levied on the production, sale, transportation, import, export, delivery or
use
of the product; and (d) outbound transportation, packing and delivery charges,
as well as prepaid freight (including shipping insurance) actually incurred;
provided however, that:
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
(i) In
any
transactions between Rosetta and an Affiliate, Net Revenues shall be only the
total amount invoiced by such Affiliate on resale to an independent third party
purchaser, in each case, after appropriate deductions as set forth
above;
(ii) In
the
event that Rosetta or its Affiliate receives non-monetary consideration for
any
transaction, Net Revenues shall be calculated based on the fair market value
of
such consideration, except that with respect to Net Revenues received in the
form of equity, Rosetta shall have the right in its sole discretion or either
pay Royalties in kind or based on the fair market value of such equity;
and
(iii) In
the
event a product is sold by Rosetta, an Affiliate of Rosetta or a sublicense
of
Rosetta in the form of a Combination Product, Net Revenues from such Combination
Product, for purposes of determining Royalties, shall be determined by
multiplying the actual Net Revenues of such Combination Product during the
applicable royalty reporting period, by the fraction A/(A+B) where: A is the
average sale price of the product based on the Results or Joint Patents that
is
contained in the Combination Product when sold separately; and B is the average
price of the other ingredient, substance, compound or element included in the
Combination Product when sold separately, in each case during the applicable
royalty reporting period or if sales of both the products based on the Results
or Joint Patents and/or other ingredient, substance, compound or elements did
not occur in such period, then in the most recent royalty reporting period
in
which sales of both occurred. In the even that such average sale price cannot
be
determined for both the product based on the Results or Joint Patents and all
other ingredients, substances, compounds or elements included in the Combination
Product, Net Revenues for the purpose of determining Royalties shall be
calculated by multiplying the Net Revenues of the Combination Products by the
fraction of C/C+D where C is the fair market value of all other ingredients,
substances, compounds or elements included in the Combination Product. 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 Results or Joint
Patent and all other additional ingredients included in the Combination
Product.
For
the
sake of clarity, Net Revenues shall not include amounts received by Rosetta
as
grants or other funding.
1.1.10 "Research"
shall
mean the joint research project of Rosetta and the Principal Investigator
intended to suppress viral activity of HCV by using HCV and human MircoRNAs
over
expression or silencing, all as specified in the Research Program.
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
1.1.11 "Research
Program"
shall
mean the detailed program for the performance of the Research attached as
Annex
A
hereto.
1.1.12 "Researched
MircoRNAs"
shall
mean a defined subset of MicroRNAs identified by Rosetta.
1.1.13 "Research
Period"
shall
mean a period of 12 months commencing on the Effective Date.
1.1.14 "Results"
shall
mean MicroRNAs identified by the parties within the framework and as a result
of
the Research, together with any other results of the Research in the
Field.
1.1.15
"Rosetta
MicroRNAs"
shall
mean any novel human and non-human (including virus and bacteria) MicroRNAs
and
tiny RNAs predicted or which may be predicted by Rosetta.
1.1.16 "Rosetta
IP"
shall
mean any and all Intellectual Property that Rosetta has developed or will
develop, or which Rosetta owns or will own, including but not limited to the
Rosetta MicroRNAs, but excluding the Results.
1.2 The
headings in this Agreement are inserted for convenience of reference only and
shall not affect its interpretation.
1.3 The
preamble and annexes to this Agreement form an integral part of this
Agreement.
2. Joint
Research
The
parties will cooperate in performance of the Research pursuant to the following
terms and conditions:
2.1 Hadasit
shall be responsible to procure the performance of the Research in accordance
with the Research Program, insofar as it relates to tasks listed in the Research
Program under the responsibility of the Principal Investigator (the
"PI
Tasks"),
as
follows:
2.1.1 The
PI
Tasks will be performed in accordance with the Research Program at and with
the
facilities and materials of HUH.
2.1.1 The
PI
Tasks will be performed by the Principal Investigator, who may be assisted
by
skilled staff of HUH under the direct supervision of the Principal
Investigator.
2.1.3 The
PI
Tasks will be performed during the Research Period.
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
2.1.4 Subject
to Section 8.7 below, Hadasit will bear the expenses incurred by it, HUH and
the
Principal Investigator in the performance of the PI Tasks and any other
obligations of Hadasit related to the Research or set forth herein.
2.2 Rosetta
shall be responsible to procure the performance of the Research in accordance
with the Research Program, insofar as it relates to tasks listed in the Research
Program under the responsibility of Rosetta (the "Rosetta
Tasks"),
as
follows:
2.2.1 The
Rosetta Tasks will be performed by Rosetta in accordance with the Research
Program at and with the facilities and materials of Rosetta.
2.2.2 The
Rosetta Tasks will be performed by skilled personal of Rosetta.
2.2.3 The
Rosetta Tasks will be performed during the Research Period.
2.2.4 Rosetta
will bear the expenses incurred by it in the performance of the Rosetta Tasks
and any other obligations of Rosetta related to the Research or set forth
herein.
2.3 Each
of
the parties hereby undertakes to take all reasonable measures in order to ensure
that it shall not utilize, in the course of performing its respective tasks
under the Research Program, any intellectual property, technology or know-how
infringing any third party intellectual property rights.
2.4 During
the performance of the Research, the research teams of Rosetta and the Principal
Investigator will periodically meet or otherwise be in contact in order to
update each other on the progress of the Research, provide information and
material regarding interim Results, and in order to coordinate further Research
activities. Each party shall prepare and maintain detailed records of , and
regularly and reasonably promptly disclose in writing to the other Parties
in
reasonable detail, any and all inventions created, invented, developed,
conceived or reduced to practice by or for such Party (including by its
employees, affiliates, agents and consultants) in connection with the Research
Program.
2.5 The
parties shall exchange final written reports regarding the Results they
respectively achieved in the course of performance of the Research, by not
later
than thirty (30) days following the end of the Research Period. Hadasit will
further provide Rosetta with any and all required documentation, information
and
material related to the Results achieved by the Principal Investigator, in
such
manner as will enable Rosetta to utilize an commercialize the Results pursuant
to the terms of the License set forth herein.
2.6 The
parties, including the Principal Investigator and his research team, will
further cooperate, to the extent requested by Rosetta, in order formalize joint
documentation describing the Results, and in order to provide any other document
or information which may be required in order to file Joint
Patents.
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
2.7 Either
party may conduct additional research projects, independently or with other
third parties in parallel to or following the Research and nothing in this
Agreement shall prevent the parties from engaging in any additional research,
provided that it fulfills its obligations hereunder.
2.8 Hadasit
represents and warrants that it is legally authorized and entitled to assume
all
responsibilities under this Agreement, including pertaining to any undertaking
related to or obligating the Principal Investigator, the HUH and the HMO, as
the
case may be.
2.9 If
Dr.
Eithan Galum ceases to serve as a Principal Investigator for any reason, Hadasit
shall promptly notify Rosetta and use its best efforts to replace him by a
substitute of similar experience and expertise within 30 days of such notice,
and Rosetta may terminate this Agreement if it does not approve such substitute
within 60 days from the date of such notice or I no such substitute is not
fund
within such time.
3.
Intellectual
Property
3.1 The
Rosetta IP belongs solely to Rosetta which is and shall remain its sole owner.
Nothing in this Agreement shall constitute or be considered as constituting
a
transfer or license of the Rosetta IP or any part thereof (including but not
limited to the Rosetta MicroRNAs) by Rosetta to Hadasit, except to the limited
extent necessary to allow Hadasit to perform its obligations under this
Agreement.
3.2 The
Hadasit IP belongs solely to Hadasit which is and shall remain its sole owner.
Nothing in this Agreement shall constitute or be considered as constituting
a
transfer or license of the Hadasit IP or any part thereof by Hadasit to
Rosetta.
3.3 All
right, title and interest in and to the Results, whether or not they shall
be
protected by Joint Patents or other intellectual property rights, vest and
shall
vest in equal undivided shares with Hadasit and Rosetta.
4.
Joint
Patents
At
the
initiative of either Party the Parties will consult with each other whether
to
file any patent applications for Joint Patents relating to the Results or any
part thereof. The following provisions will apply to any such patent
applications for Joint Patents:
4.1 Any
Joint
Patent will be listed in Annex
B
to this
Agreement, which will be amended from time to time by written consent of Rosetta
and Hadasit.
4.2 The
Joint
Patents will be registered as jointly owned by Hadasit and Rosetta, in equal
undivided shares. The Principal Investigator and inventor(s) designated by
Rosetta will be registered as the investors of each Joint Patent. If the law
of
any jurisdiction in which an application for a Joint Patent is filed requires
the application to be filed in the name of the inventors, the Parties will
use
their best efforts to procure that the Principal Investigator and any other
inventors of the patent will cooperate in so filing the application for the
patent and will thereafter assign the application to the Parties.
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
4.3 Rosetta
shall bear and pay all expenses relating to the prosecution and maintenance
of
the Joint Patents and shall control the prosecution, maintenance and litigation
of the Joint Patents.
4.4 The
prosecution and maintenance actions include but are not limited to preparing,
filing, prosecuting and maintaining patent and patent applications for the
Joint
Patent, managing any proceedings relating to any interferences or
reexaminations, or requesting reissues or patent term extensions with respect
to
the Joint patent and resolving to file the Joint Patent in additional
jurisdictions other than the initial jurisdiction in which it shall be filed,
for the purpose of obtaining wider protection for the Joint Patent.
4.5 In
the
event that Rosetta elects not to bear the expenses relating to the filing of
a
Joint Patent in a specific file or jurisdiction in which it has been already
filed as a patent application, the following terms will apply:
4.5.1 Rosetta
shall give Hadasit prior written notice within a reasonable time prior to the
date in which such expense is due, including all relevant details regarding
the
expense, and specifically indicate its intention not to pay the expense (the
"Unpaid
Expense").
4.5.2 In
such
event, Hadasit shall have the right (but not the obligation) to pay the Unpaid
Expenses, instead of Rosetta, provided that it has given Rosetta reasonable
prior written notice to Rosetta of its intent to do so.
4.5.3 In
the
event that Hadasit pays the Unpaid Expenses instead of Rosetta within sixty
(60)
days of the date of receipt of notice from Rosetta: (i) Hadasit shall take
the
control of the prosecution of the Joint Patent in the specific registry of
the
specific file or jurisdiction for which the Unpaid Expenses were paid; (ii)
Rosetta shall assign all of its rights, title and interest in the Joint Patent
registered in such specific file or jurisdiction to Hadasit, within 30 days
of a
written request by Hadasit, following payment of the Unpaid Expenses by Hadasit.
Nothing contained in sections 4.5.2 and 4.5.3 shall affect, in any way, any
rights of Rosetta under this Agreement, including rights pertaining to the
License under Section 7 below.
4.5.4 In
the
event that Hadasit has not paid the Unpaid Expenses instead of Rosetta, Rosetta
may, at any time, in its sole discretion, pay such Unpaid Expenses. In such
event, Rosetta shall notify Hadasit of its intent to do so, and sections 4.3
and
4.4 shall apply accordingly.
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
4.6 Hasdasit,
HUH and their relevant personal, including but not limited to the Principal
Investigator, shall reasonably cooperate and assist Rosetta and its patent
attorney, as shall be required in order to facilitate the prosecution and
maintenance of any Joint Patent. Such assistance will include, but shall not
be
limited to signature on any formal document or form which shall require
Hadasit's, HUH's or the Principal Investigator's signature for the purpose
of
filing or maintaining any Joint Patent.
4.7 If
so
requested, Rosetta shall consult with Hadasit and its designated patent experts
with respect to the prosecution and maintenance of Joint Patents. If the event
described in Section 4.5.3 above occurs and Hadasit assumes control of the
prosecution of a specific Joint Patent in a specific file or jurisdiction,
if so
requested Hadasit will consult with the patent experts of Rosetta with respect
to the prosecution and maintenance of such specific Joint Patent in such
specific file or jurisdiction.
5.
Protective
Actions
5.1 Each
party shall promptly notify the other party in writing of any infringement
of
purported or threatened infringement of a Joint Patent that may adversely impact
the rights of the parties hereunder, of which it becomes aware ("Infringement").
5.2 In
any
event of any Infringement, Rosetta shall be entitled, at its sole discretion,
to
institute an infringement suit or take any other appropriate legal action
against any person or entity directly or contributorily infringing any Joint
Patent ("Protective
Action").
Prior
to taking any Protective Action Rosetta will notify Hadasit of the Protective
Action it intends to take and consider Hadasit's advice regarding such
contemplated Protective Action. Such actions will be taken by legal counsel
(the
"Legal
Counsel")
chosen
by Rosetta for such purpose at its sole expense. In the event Hadasit is
included as a party to such Protective Action, the Legal Counsel will be
instructed to provide Hadasit with copies of any official letter, suit or other
document it intends to send or file on the parties' behalf, within a reasonable
time prior to sending or filing the same, and to consider any advice of Hadasit
with respect to any such Protective Action.
5.3 In
the
event that Rosetta does not institute Protective Action in response to an
Infringement within 90 days of the date on which it becomes aware of such
Infringement, Hadasit shall have the right, but not the obligation, following
30
days' prior written notice to Rosetta, to institute such suit Protective Action
in its own name.
5.4 Regardless
of which party brings the action, the other party hereby agrees to cooperate
reasonably in any such effort, including if required in order to facilitate
a
Protective Action, the furnishing of a power of attorney (and in such event,
neither party shall refuse to be included as a party to such legal
action).
5.5 Any
recovery obtained by settlement or otherwise as a result of a Protective Action
shall be disbursed as follows: (i) each party shall first recover [***]% of
the
amount of any reasonable expenses incurred by it in connection with such action
(including counsel fees); and (ii) the remaining recovery shall be treated
as
Net Revenues and allocated between the parties accordingly.
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
5.6 Without
prejudice to the above, the parties will reasonably cooperate with respect
to
any future legal claims related to a Joint Patent and neither party shall enter
into any settlement pertaining to such legal claims that affects the other
parties' rights or interests without such other parties' written consent, which
consent shall not be unreasonably withheld.
6.
Publication
The
Principal Investigator may publish the Results subject to the following terms
and conditions:
6.1 A
manuscript of any paper relating to the Results which the Principal Investigator
intends to publish (the "Proposed
Publication")
will
be submitted by Hadasit to Rosetta for review sufficiently in advance so that
Rosetta will be provided with sufficient time, which shall not be more than
60
days, to take any action required in order to protect any Intellectual Property
forming part of such Proposed Publication (the "Publication
IP").
If
requested, the Principal Investigator will delete any information from the
Proposed Publication that constitutes a trade secret or the disclosure of which
would otherwise be detrimental to Rosetta.
6.2 The
parties will discuss in good faith the Proposed Publication and if desired
will
seek to protect the Publication IP of the Proposed Publication by filing a
Joint
patent (pursuant to the provisions of Section 4 above). The resolution whether
to file a Joint patent regarding the Publication IP of a specific Proposed
Publication shall be made within 60 days from the date the manuscript of such
Proposed Publication is provided to Rosetta (the "Resolution
Period").
Such
Proposed Publication will not be published prior to such resolution or the
lapse
of Resolution Period (whichever the earlier).
6.3 In
the
event the Parties will resolve to file a Joint Patent or otherwise protect
a
Publication IP, within the Resolution Period, the Principal Investigator will
not publish the Proposed Publication prior to the filing of such Joint Patents.
Notwithstanding the above, in o event will a proposed publication be postponed
beyond 30 days after the expiration of the Resolution Period.
7.
License
7.1 Hadasit
hereby grants Rosetta an exclusive, perpetual, worldwide, royalty bearing,
license to exploit, use, conduct further research, develop and commercialize
the
Licensed IP or any part thereof in any manner (the "License").
Rosetta shall be entitled to grant sublicenses with respect to the Licensed
IP
and/or to otherwise develop or sell, independently or in collaboration with
other entities, products, services or any other inventions based on the Licensed
IP.
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
7.2 Subject
to the provisions of Section 7.5 below, Hadasit shall not be entitled to grant
any rights or licenses with respect to the Licensed IP to any third party or
to
use the Licensed IP itself other than for academic research purposes (provided
that the results of such additional academic research shall also be considered
Results for purposes of this Agreement).
7.3 Hadasit
will promptly provide Rosetta with such reasonable information and documentation
and shall further execute and deliver, or cause its representatives or employees
to execute and deliver, all such further documents or instruments, as shall
be
reasonable required by Rosetta in order to secure its rights pursuant to the
License granted hereunder.
7.4 The
exclusivity of the License with respect to specific Results or Joint Patents
may
be revoked by Hadasit in the event that Rosetta fails to commercialize the
Results or Joint Patent within a period of ten (10) years of latter of the
date
on which: (i) full and final Results were presented to Rosetta, or (ii) the
Joint patents are filed. Upon revocation of the License by Hadasit, either
party
shall be entitled to license or dispose of its interest in the Joint Patents
in
any manner it sees fit without obligation to the other party.
7.5 Without
derogating from the above, in the event that at the end of seven (7) years
following the Relevant Date, Rosetta or its affiliates shall not present
reasonable evidence that it is in the process of negotiating a commercial
transaction relating to the Results or the Joint Patents ("Commercialization
Activity"),
Rosetta shall be obliged to pay Hadasit non-refundable advance payments (the
"Advance
Payments",
which
shall be creditable against Rosetta's royalty obligations under this Agreement),
on account of future Royalties (as defined below), as a condition for
maintaining the exclusivity of the License during the period starting seven
(7)
years after the Relevant Date and until Rosetta or its affiliated demonstrates
Commercialization Activity (the "Relevant
Period"),
as
follows: (i) for the first twelve months of the Relevant Period (to the extent
applicable) - US$ [***]; (ii) for the second twelve months of the Relevant
Period (to the extent applicable) - US$ [***]; and (iii) for the third twelve
months of the Relevant Period (to the extent applicable) - US$ [***]. The
Advance Payments will be payable in quarterly installments, during each 12-month
extension period. To the extent that Commercialization Activity is demonstrated
during any of the 12 month extension period, no further installments shall
be
payable.
8.
Consideration
8.1 In
consideration for the License and any other services and obligations to be
performed by or on behalf of Hadasit, HUH or the Principal Investigator with
respect to the Research, Rosetta shall pay Hadasit royalties (the "Royalties")
out of
any Net Revenues which Rosetta or its Affiliates will actually obtain from
commercialization of the Results or the Joint Patents, as follows:
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
10
8.1.1 In
the
event that Hadasit and the Principal Investigator complete the Research in
accordance with the Agreement and the Research does not yield any Joint Patents
but does yield Results that are identifiable and of value, Hadasit shall be
entitled to Royalties equal to [***]% of the Net Revenues (the "Basic
Royalties").
8.1.2 In
the
event that Hadasit and the Principal Investigator complete the Research in
accordance with this Agreement and the Research yields Joint Patents, Hadasit
shall be entitled to:
8.1.2.1 Royalties
equal to [***]% of Net Revenues actually obtained by Rosetta from
Commercialization of any specific Results identifiable and of value which were
not registered as a Joint Patent; or
8.1.2.2 Royalties
equal to [***]% of Net Revenues actually obtained by Rosetta from
commercialization of any specific Joint Patent (i.e. the maximal Royalties
from
Net Revenues shall be [***]%);
8.1.3 In
any
other event, including an event of no Results suitable for commercialization
or
an event of a breach of this Agreement by Hadasit, Hadasit shall not be entitled
to any consideration from Rosetta, including Royalties.
8.2 Notwithstanding
anything to the contrary set forth herein, in the event that Rosetta or an
Affiliate of Rosetta must, in its reasonable judgment, make payments to one
or
more third parties to obtain a third party license from such third party(ies)
in
order to use the Results or Joint Patents or any portion thereof or due to
any
infringement of the Licensed IP of such third party rights, Rosetta may offset
such third-party payments against payments due to Hadasit pursuant to this
Section 8, provided that the amount payable by Rosetta to Hadasit shall in
no
event be reduced pursuant to this clause to an amount which is less than [***]
percent ([***]%) of the amount that would otherwise have been due to Hadasit
without the operation of this clause.
8.3 Notwithstanding
anything to the contrary set forth herein, payments due to Hadasit pursuant
to
Section 8.1.2.2 shall continue to be due, on a country by country and product
by
product basis, only during the term of a valid claim under a Joint Patent
covering such product in such country and until the expiration, termination,
withdrawal, cancellation or disclaiming of the last valid claim under a Joint
Patent covering such product in such country, after which Royalties shall
continue to be payable under Section 8.1.1 or 8.1.2.1 until the termination
of
this Agreement.
8.4 Within
thirty (30) days following the end of each calendar quarter during the Term
(as
defined below), Rosetta shall: (i) provide Hadasit with a written report which
will specify the calculation of the Revenues accumulated by Rosetta with respect
to the Results or Joint Patents in such then-completed calendar quarter and
the
Royalties payable to Hadasit under the terms of Section 8.1 above (the
"Quarterly Royalties Amount"); and (ii) pay Hadasit the Quarterly Royalties
Amount by way of bank wire transfer to such account as Hadasit shall advise
Rosetta in writing.
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
8.5 In
the
event that VAT will be duly required with respect to any Royalties which may
be
paid hereunder, the VAT will be added by Rosetta to the Quarterly Royalties
Amount against receipt of a proper tax invoice from Hadasit.
8.6 Rosetta
shall maintain complete and accurate records of Net Revenues and any amounts
payable to Hadasit in relation to same. Rosetta shall retain such records
relating to a given Calendar Quarter for at least three (3) years after the
conclusion of that Calendar Quarter. During such three (3) year period, Hadasit
shall have the right, at Hadasit's expense, to cause an independent,
nationally-recognized, certified public accountant reasonably acceptable to
Rosetta, who is bound by a suitable confidentiality arrangement with Rosetta,
to
inspect Rosetta's and the relevant Affiliates' records relating to Net Revenues
during normal business hours for the sole purpose of verifying any reports
and
payments delivered under this Agreement. Such public accountant will only repot
to Hadasit whether or not Rosetta is in compliance with its obligations under
this Agreement and shall not disclose or report to Hadasit any other information
or data to which it has access as part of this examination. The parties shall
reconcile any underpayment o overpayment within thirty (30) days after the
accountant delivers the results of the audit. Hadasit may exercise its rights
under this Section 8.6 only once every year and only with thirty (30) days
prior
notice to Rosetta. Notwithstanding the aforesaid, in the event that any
inspection as aforesaid reveals any underpayment by Rosetta to Hadasit in
respect of any year in an amount exceeding [***]% ([***] percent) of the amount
actually paid by Rosetta to Hadasit in respect of such year, then Rosetta shall
(in addition to paying Hadasit the shortfall), bear the costs of such
inspection.
8.7 For
the
purpose of sharing a portion of the costs Hadasit shall incur in the performance
of its obligations under this Agreement with respect of Research, Rosetta shall
pay Hadasit as follows (the "Research
Payment(s)"):
8.7.1 An
initial Research Payment in the amount of US $[***] shall be paid by Rosetta
to
Hadasit within five business days of the execution of this
Agreement.
8.7.2 An
additional US $[***] will be paid by ▇▇▇▇▇▇ to Hadasit one month after the
payment referred to in Section 8.7.1.
8.7.3 Hadasit
shall use its best efforts to obtain external funding for the Research in form
of or as part of a research grant in accordance with relevant industry standards
(the "Grant").
For
this purpose, Hadasit shall apply to certain reputable research institutions
as
shall be agreed between the parties. The terms of the Grant shall not derogate
from any of Rosetta's rights under this Agreement, unless otherwise agreed
between the parties in advance and in writing. When the Grant is received by
Hadasit, Hadasit shall repay to Rosetta the amounts paid under Section 8.7.1
and
8.7.2 above (the "Repaid
Amounts"),
without interest, provided that the terms of such Grant shall not prevent such
repayment to Rosetta. In the event that the Grant shall be in an amount less
than US$ [***], than Hadasit shall deduct an amount of US$ [***] from the Repaid
Amounts paid to Rosetta.
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
8.7.4 In
the
event that Hadasit does not succeed in obtaining the Grant within a period
of 12
months following the Effective Date, then, subject to the continued performance
by Hadasit of the Research and the fulfillment of all Hadasit's obligations
under this Agreement, Rosetta shall pay Hadasit additional Research Payment
in
the amount of US $[***], payable in three equal monthly
installments.
8.8 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.
9.
Indemnification
9.1 Each
party hereby disclaims any representations or warranties in respect of the
Research, the Results, the Joint Patents and any related patents, their
potential use, exploitability or that they do not infringe third party
rights.
9.2 Rosetta
shall indemnify and hold Hadasit, the HUH, the HMO and any of their employees,
(the "Indemnitees"),
harmless against and from any claim, damage or expense of any kind resulting
from any use by Rosetta, or those authorized by it, will make of the Results
or
the Joint Patents (if any), provided that Hadasit will comply with the following
terms:
9.2.1 Hadasit
shall: (i) notify Rosetta in writing of any claim or action triggering an
indemnification obligation under this Section 9.2 promptly after it becomes
aware of the same; and (ii) provide Rosetta with such information and assistance
as reasonably required in connection therewith; and (iii) enable Rosetta, at
its
request, to participate in and/or control any proceedings or negotiations
related to such defense or settlement with its own counsel.
9.2.2 Under
no
circumstance shall the Indemnitees Hadasit compromise any asserted liability
hereunder without the prior written consent of Rosetta.
9.2.3 Such
indemnity shall not apply to claims made by third parties that the Results
or
Joint Patents infringe such third party's intellectual property
rights.
9.3 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.
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.
13
10.
Confidentiality
10.1 Rosetta,
Hadasit and the Principal Investigator have previously signed and executed
a
non-disclosure agreement, in the form as Annex
C
hereto,
which forms an integral part of this Agreement (the "NDA").
10.2 It
is
recorded and agreed that Rosetta shall be entitled to disclose this Agreement,
the Results and any other information relating to the Research and the Licensed
IP, as shall be reasonably required in the scope of business, to enable a third
party to perform technological due diligence examinations relating to
contemplated transactions of Rosetta, in the course of Rosetta's
commercialization efforts or as shall otherwise be required in order to utilize
the License, as well as to its consultants and advisors (on an as-needed basis),
provided that such third parties will be subject to a confidentiality
undertaking not less stringent that the obligation set forth
herein.
11.
Term
and Termination
11.1 The
term
of this Agreement, including the License granted hereunder, shall commence
upon
the Effective Date and shall terminate on the date on which all of the Joint
Patents which may be registered under the terms set forth herein shall have
expired (the "Term").
11.2 If
the
Research does not produce any Joint Patents or Research Results with independent
commercial value, then Rosetta may terminate this Agreement upon sixty (60)
days
notice to Hadasit. In addition, in the event that either party commits a
material breach of its obligations under this Agreement and fails to cure that
breach (where the breach is capable of cure) within sixty (60) days after
receiving written notice thereof, the non-breaching party may terminate this
Agreement immediately upon written notice.
12.
Force
Majeure
Neither
party shall be responsible or liable for any delay or failure in performance
under this Agreement arising as a result of any occurrence or contingency beyond
its reasonable control, including but not limited to, accident, act of God,
acts
of the public enemy, earthquake, fire, flood, explosion, strikes, riots, civil
commotion, war (declared or not), requirements or acts of any government or
agency thereof and judicial action. The delayed party shall send written notice
of the delay and the reason therefor to the other party as soon as possible
after the party delayed knew of the cause of delay in question.
13.
Miscellaneous
13.1 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 or a sale
of
the assets that are the subject of this Agreement 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.
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.
14
13.2 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.
13.3 Law.
This
Agreement shall be governed by the laws of the State of Israel.
13.4 Mediation
& Arbitration.
The
parties shall endeavor to equitably settle any dispute which may arise between
them under or in connection to this Agreement (a "Dispute").
Any
Dispute arising between the parties not amicably resolved within 15 (fifteen)
days, shall be referred to independent mediation (the "Mediation")
by a
qualified person appointed by the parties for such purposes and failing
agreement between them within a thirty day period, by the legal counsel of
Rosetta and Hadasit, upon the written request of any of the parties (with a
copy
to the other party) (the "Mediator").
the
Mediation shall be held in accordance with the provisions of Article 79C of
the
Courts Law - 1984. The Mediator shall try to resolve the Dispute by unanimous
consent of the parties within additional 30 days and in the event the Mediator
shall fail t do so the Dispute will be referred to an arbitration (the
"Arbitration"),
which
will be conducted by the Mediator, who will serve as the arbitrator in such
event. The Arbitrator shall be bound to reason his final resolution in the
Arbitration and the Arbitration shall be subject to the substantive law (but
not
to rules of procedure and evidence).
13.5 Entire
Agreement.
This
Agreement, including all annexes attached hereto constitutes the entire
understanding of the parties and supersedes all oral or written representations
or agreements, privileges or understandings between the parties, including
but
not limited to the Joint Research Memorandum, all of which shall become, upon
signature of this Agreement, null and void.
13.6 Amendment.
No
modification or amendment of this Agreement may be made except in a written
instrument duly signed by all parties.
13.7 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.
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.
15
13.8 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.
13.9 Costs.
Each
party shall bear its own costs and expenses in connection with the negotiations
and signature of this Agreement, including taxes. Stamp tax, if required, shall
be shared equally by the parties.
13.10 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:
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▇▇
▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇
|
|
Fax:
▇▇▇-▇-▇▇▇▇▇▇▇
|
|
|
If
to Hadasit:
|
POB
12000, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇
|
|
Fax:
▇▇▇▇-▇-▇▇▇-▇▇▇▇
|
|
|
Attention:
CEO, Copy: Legal Counsel
|
13.11 Notwithstanding
anything to the contrary herein, Rosetta shall not use the names and/or logos
of
Hadasit and/or the HUH, 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, 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 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.
IN
WITNESS WHEREOF, the Parties have set their signatures hereunto as of the date
first above written.
|
HADASIT
RESEARCH SERVICES AND
|
||||
|
DEVELOPMENT
LTD.
|
||||
|
BY:
|
By:
|
|||
|
Name:
|
Name:
|
|||
|
Title:
|
Title
|
|||
As
to the
obligations imposed on the
Principal
Investigator:
______________________________
Prof.
Eithan Galum
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.
16