EXCLUSIVE TESTING AND ADMINISTRATIVE SERVICES AGREEMENT between ROSETTA GENOMICS LTD. A limited liability company under the laws of Israel, of 10 Plaut St., Rehovot, Israel, 76706 (“Rosetta”) and TEVA PHARMACEUTICAL INDUSTRIES LTD. of P.O. Box 3190...
Exhibit
4.16
between
A limited
liability company under the laws of Israel,
of 00
Xxxxx Xx., Xxxxxxx, Xxxxxx, 00000
(“Rosetta”)
and
TEVA
PHARMACEUTICAL INDUSTRIES LTD.
of X.X.
Xxx 0000 Xxxxx-Xxxxx 00000, Xxxxxx
THIS EXCLUSIVE TESTING AND
ADMINISTRATIVE SERVICES AGREEMENT (this “Agreement”) is made as of the
24th day of December, 2008, by and between: Rosetta, Ltd., through its offices
located at 00 Xxxxx Xx., Xxxxxxx, Xxxxxx, 00000 (“Rosetta”); and Teva
Pharmaceutical Industries Ltd., through its offices located at 00 Xxxxxxx Xx.,
Xxxxxxx, Xxxxxx (“Teva”).
WHERESA
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Rosetta
has developed the Tests (as such term is hereinafter defined), and is
intending to initiate the offering of the Testing Services to patients
through physicians worldwide;
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WHEREAS
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Rosetta
desires that its Testing Services be made available to patients and
physicians in the Territory (as hereinafter defined) and that Teva assist
Rosetta in that effort by and the Administrative Services (as such terms
is hereinafter defined) for and on behalf of Rosetta in and for the
Territory;
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WHEREAS
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Teva
desires to exclusively market and purchase Testing Services from Rosetta
and exclusively provide certain Administrative Services for and on behalf
of Rosetta in and for the
Territory;
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WHEREAS
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Rosetta
will exclusively in and for the Territory provide the Testing Services
ordered by Teva;
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WHEREAS
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Teva
agrees to pay Rosetta for Testing Services ordered by Teva in accordance
with the fees identified in Section 7
herein.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
NOW
THEREFORE THE PARTIES AGREE AS FOLLOWS:
1. INTERPRETATION AND
DEFINITIONS
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1.1
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The
preamble to this Agreement forms an integral part hereof and is
incorporated herein by reference.
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1.2
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Clause
headings in this Agreement are intended solely for convenience of
reference and shall be given no effect in the interpretation of this
Agreement.
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1.3
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All
signed appendices to this Agreement, whether attached at the time of
signature hereof or at any time thereafter, shall be construed as an
integral part of this Agreement.
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1.4
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In
this Agreement, the following expressions shall bear the meanings assigned
to them below and cognate expressions shall bear corresponding
meanings:
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1.4.1
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"Administrative Services"
– shall mean the sole and exclusive marketing sale and distribution and
logistic services solely provided by Teva with respect to the Tests, all
as detailed in clause 4.
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1.4.2
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“Affiliate” - with
respect to either party, means any person, corporation, company,
partnership or other entity controlling, controlled by or under common
control with such party. For such purpose the term “control” means the
holding of 50% or more of the common voting stock or ordinary shares in,
or the right to appoint 50% or more of the directors of, the said
corporation, company, partnership or
entity.
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1.4.3
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“Business Day”- shall
mean working days, not including Saturdays and Sundays and/or public
holidays and bank holidays in the US and
Israel.
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1.4.4
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“Effective Date” – shall
mean the date of signature of this Agreement by the last of the
parties.
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1.4.5
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“Instructions” – shall
mean the written instructions provided to Teva by Rosetta with respect to
the receipt of samples from its patients and physicians, shipment and
delivery of samples for testing, provide customers with the Testing
Services written reports and results, as provided by
Rosetta.
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1.4.6
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“Territory” – shall mean
Israel and Turkey. For the purpose of clarity, Israel and Turkey shall be
regarded as separate territories, and termination in relation to the
Turkey Territory (according to the terms of section 8) shall not affect
the Israeli Territory. In case of termination in relation to the Israeli
Territory the entire Agreement will be terminated unless otherwise agreed
in writing by the parties.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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1.4.7
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“Tests” – "miRview™
squamous", "miRview™ meso" and "miRview™ mets", as conducted by Rosetta
or, its Affiliated and/or other third parties on behalf of Rosetta subject
to the provisions of Section 5.1.
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1.4.8
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"Testing Services” - as
provided by Rosetta, its Affiliates and/or other third parties on behalf
of Rosetta subject to the provisions of Section 5.1 shall include the
conduct of the Tests, the provision of Test reports and results to Teva,
and the return of the paraffin blocks, when supplied. It is agreed by both
parties that other oncology testing services may be added to the above
definition upon agreement of the parties in
writing.
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1.4.9
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"Samples" – paraffin
embedded tissues and/or unstained slides processed from paraffin embedded
tissues provided from pathologists from different medical
institutions.
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2. APPOINTMENT AND
DURATION
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2.1
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Rosetta
hereby appoints Teva as an exclusive reseller of the Testing Services and
the provider of the Administrative Services in and for the Territory in
accordance with the terms of this Agreement, and Teva accepts such
appointment.
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2.2
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This
Agreement shall commence on the Effective Date and, unless terminated
earlier in accordance with Clause 8 below, shall continue for an initial
term of 24 months ("The
Term"). The Term shall be automatically renewed for an additional
periods of 12 months each unless either party gives a prior written notice
of its intention not to renew the agreement not later than 3 months before
any renewal.
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2.3
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Teva
shall be entitled at any time during the term of this Agreement in its
absolute discretion to cease the resale or marketing of the Testing
Services in the Territory (whole or part) for reasons of medical safety or
on legal or regulatory grounds; if Teva ceases resale or marketing of the
Testing Services pursuant to this Section 2.3 for a period exceeding three
(3) months then Rosetta shall have the right to terminate this Agreement
by providing Teva a ten (10) days prior written notice
.
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2.4
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Rosetta
shall be entitled at any time during the term of this Agreement in its
absolute discretion to cease providing Testing Services to Teva, in whole
or in part, for reasons of medical safety or on legal or regulatory
grounds.
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3. REGISTRATION
Within 60
days after the Effective Date, Rosetta undertakes to provide Teva with copies of
Rosetta’s CAP and CLIA licenses and certificates. In addition, at Teva’s
request, Rosetta will provide Teva with one copy of other existing and readily
available documentation to the extent required by Teva for any and all
regulatory purposes.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
4. ADMINISTRATIVE
SERVICES
Teva
undertakes and agrees with effect from the Effective Date and at all subsequent
times during the term of this Agreement, in connection with the provision of
Administrative Services for and on behalf of Rosetta:
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4.1
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to
use all reasonable endeavours to market the Testing Services in the
Territory subject to the terms and conditions of this Agreement and to
perform at its own expense, all tasks and duties and assume all
responsibilities customarily associated with marketing of the Testing
Services;
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4.2
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to
market Testing Services only from Rosetta, subject to Rosetta’s ability to
carry out the Testing Services in accordance with this Agreement, all
pursuant to section 2.3 herein;
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4.3
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further
to marketing the Testing Services, Teva shall be responsible for the
receipt of samples in accordance with Instructions from its customers,
shipment and delivery of the Testing Services kit according to the
Instructions to Rosetta for testing, and upon completion of testing, to
provide its customers the Testing Services written reports and results, as
provided by Rosetta, according to the
Instructions.
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4.4
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to
obtain and maintain all government licenses, approvals and permissions
necessary in connection with the marketing, resale and provision of the
Testing Services to persons in the
Territory;
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4.5
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to
inform Rosetta of any matter in the Territory of which it is aware that is
likely to affect, significantly, the marketing of the Testing
Services;
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4.6
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to
provide Rosetta with market and sales information in a timely fashion
including information relating to the sales and marketing activities of
Teva with respect to the Testing
Services,;
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4.7
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to
handle all physician, patient and other inquiries, whether via telephone
or in writing, regarding Rosetta’s provision of Testing Services,
including information relating to the results of such Testing
Services;
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4.8
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to
inform Rosetta of any reports of irregularities, complaints or other
adverse information received by Teva relating to the Tests, its use or
quality and/or the Testing Services, and not to take any action with
regard thereto, unless required by law or the regulatory authorities in
the Territory, without obtaining Rosetta’s prior written consent, such
consent to be provided promptly and not unreasonably withheld by
Rosetta;
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4.9
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to
conduct its marketing activities in a manner that reflects favorably at
all times on the Testing Services and the name, goodwill and reputation of
Rosetta; to refrain from engaging in deceptive, misleading or unethical
practices,
including but not limited to, disparagement of Rosetta or the Testing
Services, and acceptance or payment of bribes, kickbacks or secret
profits; to make no representations, warranties, guarantees or covenants,
with respect to the Testing Services, other than those set forth in the
Promotional Materials, as defined thereafter, provided to Teva by Rosetta;
and not to modify any Promotional Materials without Rosetta’s prior
written consent;
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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4.10
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not
to modify in any manner whatsoever the Test reports and results or
disclaimers associated with such
reports;
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4.11
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unless
otherwise mutually agreed in writing, to be solely responsible for all
expenses, costs, liabilities and obligations Teva incurs in connection
with its resale of the Testing Services and the provision of the
Administrative Services identified
herein.
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5. ROSETTA’S
UNDERTAKINGS
Rosetta
undertakes and agrees with effect from the Effective Date and at all subsequent
times during the term of this Agreement:
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5.1
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to
provide either by itself or through third parties all of Teva’s
requirements solely and exclusively to Teva for Testing Services ordered
by licensed physicians in the Territory for persons located in the
Territory; Rosetta shall not knowingly provide commercial Testing Services
for a fee to physicians located in the Territory other than through Teva.
All other activities for research purposes only in the Territories will be
coordinated between Teva and Rosetta, and will be conducted according to
applicable law and regulations. Rosetta shall have the right to perform
the Testing Services via third parties subject to the following: (i)
Rosetta being the responsible party; (ii) the Third Party shall have at
least the same capabilities of Rosetta. In the event that Teva shall
refuse the transfer of performance of Services to a third Party due to the
fact that such third Party does not have the same capabilities of Rosetta,
then this agreement at the sole discretion of Teva will be either
terminated or modified to a non exclusive
agreement.
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5.2
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to
assist and financially share all expenses relating to and/or resulting
from conferences, seminars etc, all as will be mutually agreed (agreement
to be made at the sole discretion of each party) and the details with
respect to such events (including without limitation the details of the
financial aspects of such event) will be added, from time to time, as an
Appendix to this Agreement.
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5.3
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to
provide [***] to be [***] from signing this
Agreement.
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5.4
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to
provide Teva with a minimum of [***] Testing Services for compassionate
use programs, upon Teva's sole
discretion.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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5.5
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to
provide all of Teva’s requirements for the Testing kits to collect the
samples, and to deliver Test report and results within [***] of receipt of
all relevant, complete and sufficient patient information and materials,
including without limitation, Samples, from Teva. The report and results
may be delivered to Teva by telefax or electronic
mail.
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5.6
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if
paraffin blocks are provided, to return the remainder of the paraffin
blocks to Teva within 1 month, of the conduct of the Tests, unless
otherwise requested by Teva; the cost of such shipments shall be borne by
Rosetta;
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5.7
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if
Teva provides a Sample, in accordance with the Instructions, and Rosetta
performs the Testing Services on such Sample, but is unable to provide a
report with respect to such Sample, then, at, Rosetta’s expense, Rosetta
will either retest the Sample at its sole expense, or notify Teva that
such Sample will not be retested. If such Sample will not be retested,
Rosetta will not charge Teva for the testing of such
Sample;
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5.8
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If
Teva provides a Sample, not according to the Instructions, Rosetta will
notify Teva that such Sample will not be tested. Rosetta will charge Teva
only for cost of kit shipment to Rosetta’s lab and cost of pathologist
review (if applicable);
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5.9
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if
Teva provides a Sample according to the Instructions with respect thereto,
and Rosetta performs the Testing Services on such Sample, and Rosetta
becomes aware that there was an error made in the Testing Services which
affected the Test results, then, at Rosetta’s expense, Rosetta will either
retest the Sample at its sole expense, or notify Teva that such Sample
will not be retested. If such Sample will not be retested, Rosetta will
either not charge, or credit, as applicable, Teva for the Testing of such
Sample.
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5.10
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In
order to ensure the fulfillment of Rosetta’s responsibilities and
obligations in accordance with this Agreement, Rosetta is obligating to
insure in its own responsibility itself and its employees, in a suitable
and known insurance company commencing as of the Effective Day and shall
maintain for the duration of this Agreement and [***] at its expense the
following insurances, and to provide Teva with proof in a form of
certificate of insurance attached as an Exhibit C of such
insurances.
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5.11
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Fulfilling
the above mentioned insurance, based on this agreement and the payment of
the insurance sum in accordance, are considered the basic condition of
this agreement.
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5.12
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None
of the above insurance obligation will reduce Rosetta’s obligations, in
accordance with this Agreement and in accordance with any
law.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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5.13
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Rosetta
is obligated to inform Teva about any cancellation and/or reduction in
coverage of the Insurance policy and/or modification which shall
negatively effect Teva pursuant to this
Agreement
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5.14
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Rosetta
undertakes to provide Teva, free-of-charge, all reasonable support and
marketing expertise, including copies of such promotional material as may
be available from time to time, specific to the Testing Services necessary
or useful for Teva in order to assist Teva in promoting and marketing the
Testing Services in the Territory. Teva shall have the right to consult
Rosetta regarding the nature and usage of these promotional materials.
Teva will be responsible for all regulatory compliance of the promotional
material in the Territory.
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5.15
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Other
than as expressly provided in this agreement, the Testing Services are
provided ‘as is’ without warranty of any kind, whether express or implied,
including without limitation warranties of merchantability, fitness for a
particular purpose and non-infringements, and Rosetta disclaims any and
all such warranties. Rosetta may decline to provide Testing Services on a
specimen received from Teva that does not meet the
Instructions.
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6. TRADEMARKS
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6.1
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The
Testing Services shall be marketed by Teva under only such trademarks,
service marks and/or other insignia of origin registered in Israel under
Rosetta’s name or anyone on its behalf, as will be decided upon by
Rosetta, in its sole discretion (the “Xxxxxxx
Xxxxx”).
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6.2
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During
the term, and subject to the terms and conditions, of this Agreement and
for the Territory only, Rosetta hereby grants to Teva a non-exclusive,
non-transferable, limited license to use the Xxxxxxx Xxxxx solely in
connection with the marketing of the Testing Services and the provision of
Administrative Services in the Territory, provided
that:
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6.2.1
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Teva’s
use of the Xxxxxxx Xxxxx must comply with the Trademark Usage Guidelines
as provided by Rosetta to Teva and attached as an Exhibit A to this
Agreement, as may be amended by Rosetta from time to time upon sufficient
prior written notice to Teva.
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6.2.2
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Teva
shall ensure that all marketing materials or other documents on which the
Xxxxxxx Xxxxx are placed by Teva (the “Marked Materials”) shall not
reflect adversely upon the name, goodwill or reputation of Rosetta. Teva
agrees that the Marked Materials shall be of such nature, style,
appearance and quality as shall be adequate and suited to the protection
of the Xxxxxxx Xxxxx and the goodwill associated
therewith.
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6.2.3
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Teva
shall submit to Rosetta, free of cost, two samples of Marked Materials
prior to the dissemination or distribution of the Marked Materials.
Rosetta, in Rosetta’s sole discretion, shall have the right to review the
Marked Materials submitted by Teva to confirm compliance with this
Agreement. If Rosetta disapproves of any sample of the Marked Materials,
Rosetta shall provide Teva with the specific reasons for such disapproval.
Teva shall promptly make all such changes to the Marked Materials as
Rosetta shall request to protect the value of the Xxxxxxx
Xxxxx.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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6.2.4
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Teva
shall not use the Xxxxxxx Xxxxx, or any part thereof, as part of or in
combination with any other names or trademarks except with Rosetta’s prior
written approval. Teva shall not use any confusingly similar or diluting
xxxx, term or design, and shall not attempt to register or aid any third
party in using or attempting to register any such xxxx, term or design.
Teva shall not use any of the Xxxxxxx Xxxxx in any manner that indicates
that it is using such xxxx other than as a
licensee.
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6.2.5
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If
Teva refuses to submit such samples, after being requested by Rosetta to
do so in writing or violates the provisions of this Clause 6 and/or the
Rosetta Trademark Usage Guidelines and does not submit the samples, or
cure the violation within 30 days after being notified of the same,
Rosetta shall have the right to revoke the license granted to Teva
pursuant to this Clause 6.
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6.2.6
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The
Xxxxxxx Xxxxx and the goodwill associated therewith are and remain
Rosetta’s exclusive property. Teva shall acquire no right, title or
interest in the Xxxxxxx Xxxxx or the goodwill associated therewith, other
than the limited license and right to use the Xxxxxxx Xxxxx set forth in
this Clause 6. All usage of the Xxxxxxx Xxxxx by Teva shall inure to
Rosetta’s benefit. Teva shall not knowingly do or suffer to be done any
act which would impair the Xxxxxxx Xxxxx or the goodwill associated
therewith. Teva shall take any actions reasonably requested by Rosetta,
and upon Rosetta sole expense, including the execution of instruments,
that may be necessary or appropriate to register or otherwise confer or
perfect Rosetta’s rights in the Xxxxxxx Xxxxx in the Territory in
Rosetta’s name. Teva agrees to take no action inconsistent with Rosetta’s
ownership of and interest in the Xxxxxxx Xxxxx, or assist any third party
in doing any of the same.
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6.2.7
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Teva
was advised that the Xxxxxxx Xxxxx, are and shall remain Rosetta’s. Teva
shall have no claim with regard to the said Xxxxxxx Xxxxx and shall not
challenge Rosetta’s title to the Xxxxxxx Xxxxx or the validity of their
registration, if they are
registered.
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6.2.8
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Under
no circumstances will anything in this Agreement be construed as granting,
by implication, estoppel or otherwise, any licenses
or rights in the Xxxxxxx Xxxxx not expressly granted to Teva in this
Clause 6.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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6.3
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Rosetta
is aware that “Teva” is a registered trade-name/xxxx of Teva (the “Teva
Trademark”). It is agreed that the Teva Trademark shall not include the
trademarks of Rosetta, whether registered or not (and visa
versa).
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6.4
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The
Teva Trademark is or shall be registered in the Territory in Teva’s name,
and at its expense.
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6.5
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The
Teva Trademark, whether registered or not, is and shall remain Teva’s.
Rosetta shall have no claim with regard to the said Teva Trademark and
shall not challenge Teva’s title to the Teva Trademark or the validity of
its registration, if it is registered, even after termination of this
Agreement for any reason.
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7. PRICE AND TERMS OF
PAYMENT
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7.1
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Teva
shall pay to Rosetta a fee per Test for the Testing Services that Rosetta
performs under this Agreement in the amount as set forth in Exhibit B. Any
change based on the review shall be made only upon the written agreement
of the parties to be provided at their sole
discretion.
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7.2
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Terms
of payment - [***], except that Teva may withhold any amounts that are the
subject of a good faith dispute until such dispute is resolved. All
payments shall be made in full and without setoff, upon order, by bank
transfer in U.S. dollars available at Rosetta’s U.S. bank, or otherwise as
Rosetta may direct in advance.
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7.3
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Teva
shall be solely responsible for setting the pricing for its clients, and
for collecting payment from its clients, for the Testing Services, and
Teva’s delay in collecting, or failure to collect, shall not affect Teva’s
obligation to pay Rosetta the applicable fees in any
way.
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8. TERMINATION
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8.1
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Notwithstanding
the above, and without prejudice to any other rights to which it may be
entitled, either party may terminate this Agreement upon written notice of
termination to the other party:
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8.1.1
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if
the other party is in material breach of any of the material terms hereof
and fails to remedy such breach [***] of that party being notified of such
breach; or
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8.1.1.1
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if
the other party is, admits to being or is declared insolvent, or voluntary
or involuntary proceedings are instituted by or against it in bankruptcy,
or receivership, or
for a winding-up or for the dissolution or re-organization of its assets;
or
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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8.1.1.2
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based
on medical safety or legal or regulatory
reasons.
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8.2
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In
the event that the Agreement is terminated with respect to the Turkey
territory then the Agreement will continue to be applicable with regard to
the Israeli territory. In the event that the Agreement is terminated with
regard to the Israeli Territory then the entire Agreement will be
terminated, unless otherwise agreed between the Parties in
writing.
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8.3
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Termination
for breach will have no effect on any performance obligations which have
accrued up to the effective date of such
termination.
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9. EFFECTS OF
TERMINATION
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9.1
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Termination
of this Agreement howsoever caused shall be without prejudice to any other
rights or liabilities accrued at the date of
termination.
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9.2
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Upon
termination of this Agreement, all rights and licenses granted to Teva
hereunder shall immediately terminate, and Teva shall immediately cease
marketing and distributing the Testing Services, except as expressly
provided in Clause 9.3.
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9.3
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Upon
termination of this Agreement, Teva shall notify Rosetta of any
outstanding unstained slides or paraffin blocks it has in its possession,
and Rosetta shall notify Teva of any outstanding Teva’s customers’ Tests
it has, which have not been sent to Teva (whether completed or not).
Subject to Teva’s advance payment of the applicable fees, Rosetta
undertakes to complete the relevant Testing Services. Notwithstanding the
foregoing, Rosetta will not be obligated to complete the Testing Services
if Rosetta terminates this Agreement due to Teva’s breach or due to
reasons of medical safety or legal or regulatory
grounds.
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9.4
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Neither
party shall have any liability to the other for claims based on
termination of this Agreement in accordance with Clause 8, including
without limitation for compensation, reimbursement or damages for the loss
of prospective profits, anticipated sales or goodwill. If a Party is
entitled under local law or otherwise to any special payment or
termination remedy or indemnity as a consequence of the expiration or
termination of this Agreement, such Party hereby waives and disclaims, to
the fullest extent permitted by law, any right to such payment, remedy or
indemnity.
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9.5
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Clauses
1, 5.8, 6.5, 10, 11, 13, 18, 22 and 24 shall survive any expiration or
termination of this Agreement.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
10.
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HOLDING HARMLESS &
INDEMNIFICATION
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10.1
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Teva
shall be solely responsible for any false or misleading statements, false
or misleading representations or false or misleading warranties, whether
oral or written, made by Teva to its clients. Without limiting the
generality of the foregoing, Teva agrees and undertakes that it will not
make any false or misleading statement, representation or warranty, oral
or written, concerning the Tests and/or the Testing Services. In the event
that Teva should make any false or misleading statements, representations
or warranties, and claims should arise therefrom, Teva shall defend,
indemnify and hold Rosetta, its affiliates, employees and agents
(including successors and assigns) harmless from and against any and all
costs, damages, expenses and liabilities arising out of or related to such
statement, representation or
warranty.
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10.2
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Rosetta
shall be solely responsible for any false or misleading statements, false
or misleading representations or false or misleading warranties made in
the Promotional Materials provided by Rosetta to Teva. In the event that
the Promotional Materials shall contain any false or misleading
statements, representations or warranties, and claims should arise
therefrom, Rosetta shall defend, indemnify and hold Teva, its affiliates,
employees and agents (including successors and assigns) harmless from and
against any and all costs, damages, expenses and liabilities arising out
of or related to such statement, representation or
warranty.
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10.3
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Rosetta
agrees to defend, indemnify and hold Teva, its affiliates, employees and
agents (including successors and assignees) harmless from and against any
claim by a third party and any and all costs, damages, expenses (including
attorneys’ fees and other costs of litigation) and liabilities directly
resulting therefrom arising out of infringement of third party
intellectual property rights by the Testing Services, Rosetta’s negligence
or willful misconduct in Rosetta’s provision of the Testing Services, or
any breach by Rosetta of any of the terms of this Agreement, provided, however, that
this indemnity shall not extend to any claim, demand, or legal action to
the extent arising from any negligent act or omission or willful
misconduct of Teva (including successors and assignees if
applicable).
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10.4
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Teva
agrees to defend, indemnify and hold Rosetta, its affiliates, employees,
agents (including successors and assignees) harmless from and against
claim by a third party and any and all costs, damages, expenses (including
attorneys’ fees and other costs of litigation) and liabilities directly
resulting therefrom arising out of Teva’s negligence or willful misconduct
in Teva’s provision of the Testing Services, or as result of any breach by
Teva of any of the terms of this Agreement, provided, however, that
this indemnity shall not extend to any claim, demand, or legal action
to
the extent arising from any negligent act or omission or willful
misconduct of Rosetta (including successors and assignees if
applicable).
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
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10.5
|
The
indemnity obligations under this Clause 10 are contingent upon: The party
seeking indemnification (the “Indemnified Party”) (a) notifying the
Indemnifying Party as soon as reasonably possible in reasonable detail of
any claim, demand, action or proceeding for which indemnification is
sought (the “Indemnified Claim”), (b) allowing the Indemnifying Party to
control the defense and/or settlement of the Indemnified Claim, and (c)
providing the Indemnifying Party with assistance in any defense and/or
settlement thereof at the Indemnifying Party’s
expense.
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10.6
|
The
Indemnifying Party shall at its expense, assume the defense thereof using
counsel reasonably acceptable to the Indemnified Party. The Indemnified
Party shall have the right to participate at its own expense, in the
defense and/or settlement of any third party claim, demand, action or
proceeding. In connection with any such third party claim, demand, action
or proceeding, the parties shall cooperate with each other and provide
each other with access to relevant books and records in their possession.
No such third party claim, demand, action or proceeding shall be settled
without the prior written consent of the parties, which consent shall not
be unreasonably withheld. The Indemnifying Party shall reimburse the
Indemnified Party upon demand for any payments made based upon a
conclusive judgment of any court of competent jurisdiction or pursuant to
a bona fide compromise or settlement of claims agreed and accepted by the
Indemnifying Party, in respect to any damages related to any claim under
this Clause 10. In the event that the parties agree to settle a claim or
action, such settlement shall not be publicized without the prior written
consent of the parties, which consent shall not be unreasonably
withheld.
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10.7
|
The
provisions of this Clause shall survive the expiration or termination of
this Agreement for any reason.
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11. CONFIDENTIALITY
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11.1
|
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 for a period of five (5) years
from the date hereof. The foregoing non-disclosure and non-use obligations
shall not apply to the extent that such Proprietary
Information:
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(i)
|
is
known by the receiving Party at the time of its receipt, and not through a
prior disclosure by the disclosing Party, as documented by contemporaneous
written records;
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
(ii)
|
is
in the public domain or
knowledge;
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(iii)
|
is
subsequently disclosed to a receiving Party by a Third Party who may
lawfully do so and is not under an obligation of confidentiality to the
disclosing Party; or
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(iv)
|
is
developed by the receiving Party independently of Proprietary Information
received from the other Party, as documented by contemporaneous research
and development records.
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11.2
|
Notwithstanding
Section 11.1, a Party receiving Proprietary Information of the other Party
may disclose such Proprietary
Information:
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(i)
|
to
governmental or other regulatory agencies in order to obtain patents, or
to gain approval to conduct clinical trials or to market the Tests and/or
the Testing Services to the extent permitted hereunder, but such
disclosure may be only to the extent reasonably necessary to obtain such
patents or authorizations;
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(ii)
|
to
its respective agents, consultants, Affiliates, potential and actual
sublicensees, and/or other Third Parties for the research and development,
manufacturing and/or marketing of the Tests and/or the Testing Services
(or for such Third 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;
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(iii)
|
to
actual or prospective acquirers or sources of financing on the condition
that such Third Parties agree to be bound by the confidentiality
obligations contained in this Agreement;
or
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(iv)
|
if
required to be disclosed by law or court order, provided that, to the
extent permitted by law, 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 (or any applicable stock exchange or regulatory organization),
may file this Agreement as an exhibit to any filing with the SEC (or any
applicable stock exchange or regulatory organization) and may distribute
any such filing in the ordinary course of its business. However, to the
maximum extent allowable by SEC (or any applicable stock exchange or
regulatory organization) rules and regulations, the Parties shall be
obligated to maintain the confidentiality obligations set forth herein and
shall redact any confidential information
set forth in such filings as may be reasonably requested by the disclosing
Party.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
|
11.1
|
The
provisions of this Clause shall survive the expiration or termination of
this Agreement for any reason.
|
12. FORCE
MAJEURE
|
12.1
|
The
obligations of each party under this Agreement shall be suspended during
the period of this Agreement and to the extent that such party is
prevented or hindered from complying herewith by any cause beyond its
reasonable control including (insofar as they are beyond such control but
without prejudice to the generality of the foregoing expression) strike,
act of God, war, riot, civil commotion, malicious damage, compliance with
any law or governmental order, rule, regulation or direction, accident,
breakdown of plant or machinery, fire, flood, storm, difficulty or
increased expense in obtaining workmen, materials or transport or other
circumstances affecting the supply of goods or of raw materials
therefor.
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12.2
|
In
the event of either party being so hindered or prevented, such party shall
give notice of suspension as soon as reasonably possible to the other
party stating the date and extent of such suspension and the cause
thereof. The failure to give such notice shall forfeit the rights of such
party to relief under this Clause.
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12.3
|
Any
party whose obligations have been suspended as aforesaid shall resume the
performance of such obligations as soon as reasonably possible after the
removal of the cause and shall so notify the other party. In the event
that such cause continues for more than six months either party may
terminate this Agreement on thirty days notice to the other
party.
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13. GOVERNING
LAW
This
Agreement shall be governed and interpreted according to the laws and
regulations of Israel. Any dispute between the parties shall be referred to the
applicable court of Tel Aviv, Israel.
14. ENTIRE
AGREEMENT
This
Agreement constitutes the entire understanding between the parties hereto with
respect to the subject matter hereof and supersedes all prior and
contemporaneous agreements, negotiations and discussions between the parties
hereto relating thereto.
15. EXECUTION AND DELIVERY OF
THIS AGREEMENT
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15.1
|
Rosetta
hereby represents and warrants that the execution and delivery by Rosetta
of this Agreement and the performance by Rosetta of its obligations
hereunder have been duly authorized by all necessary corporate
action on the part of Rosetta, and do not conflict with the terms of any
other contract, agreement, arrangement or understanding to which Rosetta
is a party.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
|
|
15.2
|
Teva
hereby represents and warrants the execution and delivery by Teva of this
Agreement and the performance by Teva of its obligations hereunder have
been duly authorized by all necessary corporate action on the part of
Teva, and do not conflict with the terms of any other contract, agreement,
arrangement or understanding to which Teva is a
party.
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16. INDEPENDENT
CONTRACTORS
All work
performed by the parties under this Agreement shall be as independent
contractors. None of the parties hereto are an agent, employee, partner,
representative or joint venturer of the other party and nothing in this
Agreement shall be construed to create such a relationship. None of the parties
hereto shall have the power or right to bind or obligate the other. The parties
hereby represent and warrant that each of them have the power and authority to
undertake the contractual commitments set forth in this Agreement and that the
execution of this Agreement and its performance of the services shall not
constitute a breach or default under any agreement which any of the parties have
entered into with any third party.
17. TERMS AND
CONDITIONS
The
Testing Services supplied to Teva shall be supplied upon the terms and
conditions contained herein and any standard terms and conditions of sale or
conditions of purchases shall be of no effect, unless the parties otherwise
agree expressly and in a writing signed by both parties.
18. AMENDMENTS
No
amendment or variation of this Agreement shall be effective unless in writing
and signed by duly authorized representatives of the parties.
19. ASSIGNMENT
None of
the Parties hereto shall without the prior written consent of the other Parties,
assign, sub-license, sub-contract, delegate, charge or part with or otherwise
dispose of this Agreement or the benefit thereof or any right or obligation
hereunder or grant any sub-license or sub-contract, save that any Party shall be
entitled to assign this Agreement to one of its Affiliates. provided, however,
that either Party may assign this Agreement and its rights and obligations
hereunder without the consent of the other Party hereto to an Affiliate or in
connection with the transfer or sale of all or substantially all of its assets
related to Licensed Product or its business in the event of its merger or
consolidation or change in control or similar transactions. Any permitted
assignee shall assume all obligations of its assignor under this Agreement. and,
inter alia will be responsible to provide the other party with an amended
certificate of insurance in the exact wording as attached to this Agreement
Exhibit C. Any assignment or attempted assignment contrary to the provisions
hereof shall be null and void. In this respect, if the above mentioned
assignment will have a financial or commercial negative effect on Teva's
activities in Israel or abroad,
which such effect will be examined under a test of reasonability, Teva will have
the right to terminate this Agreement upon notice of termination to Rosetta
within thirty (30) days.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
20. SEVERABILITY
The
invalidity or unenforceability of any term of or any right arising pursuant to
this Agreement shall not in any way affect the remaining terms or rights unless
the invalid provision goes to the essence of this Agreement. Rosetta and Teva
hereby each undertakes to cooperate in good faith and to use all reasonable
endeavors to replace any legally unenforceable provision with (as far as
practicable) provisions which will effect for the parties the same commercial
results as were intended by the original provisions.
21. WAIVER
The
failure of a party hereto to exercise or enforce any right under this Agreement
shall not be deemed to be a waiver thereof nor operate so as to bar the exercise
or enforcement thereof at any time or times thereafter.
22. SURVIVAL OF
INDEMNITY
Each
indemnity in this Agreement is a continuing obligation separate and independent
from the other obligations of Rosetta and Teva and survives termination of this
Agreement.
23. NOTICES
All
notices shall be in writing and shall be given by delivery by hand, by first
class mail postage prepaid, by air courier, or by transmission by fax to the
address or to the fax number of the relevant party set out at the beginning of
this Agreement or such other address or fax number as either party may notify to
the other from time to time and shall be addressed to the representatives of the
parties set out below:
If to
Rosetta:
Attention:
Xx. Xxxxx Xxxxx
Chief
Commercialization Officer
Rosetta
Genomics Inc.
00
Xxxxxxxx Xxxxx, xxxxx 000, Xxxxxx Xxxx XX 00000
Tel:
000.000.0000
Fax:
000.000.0000
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
With a
copy to:
General
Counsel
00 Xxxxx
Xx.
Xxxxxxx
Tel:
x000.00.000.0000
Fax:
x000.00.000.0000
If to
Teva:
Attention:
[***]
[***]
Teva
Pharmaceutical Industries Ltd.
[***]
[***]
[***]
[***]
With a
copy to:
Teva
Pharmaceutical Industries Ltd.
0 Xxxxx
Xxxxxx, Xxxxx Xxxxx 00000, Israel
Attention:
Legal Department
Fax:
000-0-0000000
The
parties shall inform the other within 7 Business Days of any change in address
or fax number. Any such notice given as aforesaid shall be deemed to have been
given (i) if mailed, 7 days after being dispatched by mail postage prepaid; (ii)
if by air courier, 4 days after delivery to the air courier company; (iii) if by
facsimile with confirmed transmission, 48 hours after transmission. An
additional copy of all notices issued by either party to the other relating to
breach or termination of this Agreement shall be sent, in cases of notices to
Rosetta, to Rosetta’s business development department, facsimile number
__________, and in cases of notices to Teva, to : 000-0-0000000.
24. LIMITATION OF
LIABILITY
In no
event will either party be liable for any consequential, indirect, incidental,
punitive, exemplary or special damages under or related to this Agreement,
however caused and under any theory of liability, including without limitation,
breach of contract, breach of warranty or tort.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
25. PRESS
RELEASE
Following
the execution of this Agreement the Parties will jointly word a press release
regarding the execution of this Agreement. The press release will be released as
a joint release of the two parties.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
IN WITNESS WHEREOF, the
parties hereto have hereunto set their hands as of the date first set forth
above.
By: /s/ Xxxx
Xxxxxxx
Title General
Counsel
Date January 9,
2009
By: /s/ Xxxxx
Xxxxxxxx
Title EVP R
&D
Date January 9,
2009
TEVA
PHARMACEUTICAL INDUSTRIES LTD.
By: /s/
[***]
[***]
[***] -
Teva Pharmaceutical Industries Ltd.
Date
By:
/s/
[***]
Date
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
EXHIBIT
A
[***]
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
EXHIBIT
B
[***]
[***]
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[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
EXHIBIT
C
[***]
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.