LABORATORY SERVICES AGREEMENT
Exhibit
4.18
This
Laboratory Services Agreement (“Agreement”) is made
and entered into effective as of April 10, 2009, (the “Effective Date”) by
and between Rosetta
Genomics Inc., a
corporation organized under the laws of Delaware, having a principal place of
business at 0000 Xxxxxx Xx., Xxxxx 000, Xxxxxxxxxxxx, XX, 00000 (“Rosetta”), and Prometheus
Laboratories Inc., a California corporation,
having its principal place of business at 0000 Xxxxxxx Xxxx Xxxxx, Xxx Xxxxx, XX
00000 XXX (“Prometheus”). Rosetta
and Prometheus each may be referred to herein as a “Party” or collectively as
the “Parties”.
Recitals
Whereas,
the Parties have entered into that certain License Agreement simultaneously
herewith for the license to Prometheus of certain intellectual property rights
owned or controlled by Rosetta covering certain Diagnostic Tests which will be
exploited by Prometheus in the Prometheus Territory (the “License Agreement”;
capitalized terms not defined herein shall have the definitions ascribed in the
License Agreement);
Whereas,
Rosetta is capable of performing the Diagnostic Tests; and
Whereas,
in connection with Prometheus’ Exploitation of its rights under the License
Agreement, Prometheus desires that Rosetta provide the Services (as defined
below) under the terms and conditions set forth in this Agreement and Rosetta
desires to provide the Services for Prometheus.
Agreement
Now
Therefore, in consideration of the mutual promises and covenants set
forth herein and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties, intending to be
legally bound, agree as follows:
1.
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THE
SCOPE OF THE SERVICES
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1.1 The
Services. Rosetta shall perform the Diagnostic Tests for
Prometheus with respect to specimens sent by Prometheus to Rosetta and obtained
from any person inside the Prometheus Territory (the “Services”).
1.2 SOP. Rosetta
shall perform each Diagnostic Test according to the standard operating
procedures (“SOP”) agreed upon in
writing by the
Parties, which may be amended from time to time subject to the Parties’ mutual
written consent. Rosetta agrees not to change or deviate from the SOP
without Prometheus’ prior written approval.
1.3 Customer
Service. Prometheus shall be solely responsible for all
customer service relating to the Services, including opening customer accounts,
ordering and disseminating collection kits to customer
accounts, paying for and tracking the shipment of Laboratory Samples
(defined below) to Rosetta at the Licensed Facility (defined below), and
providing to customer the Test Results (defined below) supplied by Rosetta to
Prometheus.
1.4 Standard
Disclaimers. Prometheus shall provide in writing to all
customers that order Diagnostic Tests the standard disclaimers and collection
instructions attached hereto as Exhibit 2, as such
Exhibit may be modified from time to time upon the mutual written agreement of
the 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.
CONFIDENTIAL
2.
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CONDUCT
OF DIAGNOSTIC TESTS
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2.1
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Performance of
Services.
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a) Rosetta
shall timely perform all Services to meet the requirements of Prometheus and its
Affiliates in the Prometheus Territory, in accordance with Rosetta’s maximum
turnaround time for the performance of each Diagnostic Test set forth in Section
4.1 and business operating procedures agreed in writing by the Parties from time
to time. Rosetta will process Laboratory Samples in the order
received unless otherwise requested in writing by Prometheus, and,
notwithstanding anything herein, (unless otherwise agreed to in writing by a
duly authorized representative of Rosetta) in no event shall Rosetta be required
to process more than [***] Laboratory Samples per business day.
b) Rosetta
shall use reasonable care and comply with generally prevailing industry
standards in the performance of the Services and in the preparation of all
findings, conclusions, assessments and reports in connection
therewith. Rosetta shall perform the Services in compliance with all
Laws.
2.2 Further Information.
After a Diagnostic Test has been completed, Rosetta may be requested by
Prometheus to provide additional information concerning any Diagnostic Test
performed by Rosetta, including such information and other scientific or
technical information reasonably required to be disclosed to fulfill the
objectives of 42 C.F.R. 493.1445(9) and as reasonably provided by CLIA
certified laboratories. Upon such a request by Prometheus or a Prometheus
customer, Rosetta shall provide the requested information subject to generally
accepted industry standards relating to the protection of confidential
information. Under no circumstances shall Rosetta be required to make any
clinical decision or offer any clinical interpretation of the Test Results
(defined below). Rosetta shall make available upon reasonable request its
laboratory director and a senior scientist to be identified by Rosetta to
address questions relating to the Diagnostic Tests which may arise from health
professionals from time to time during the Term of this Agreement.
Notwithstanding the foregoing, the Parties shall use reasonable efforts to work
together in good faith to protect information which each party considers and has
previously protected as strictly confidential information.
2.3 Laboratory
Samples. Prometheus shall be responsible for supplying
collection kits to customers and delivering Laboratory Samples to Rosetta for
testing. Rosetta shall dispose of any waste generated from its
possession, testing or creation of the Laboratory Samples in accordance with all
Laws and the terms of the applicable SOP. For the purposes of this
Section, “Laboratory
Samples” shall mean any tissue sample that Prometheus furnishes to
Rosetta for any purpose related to this Agreement, or that Rosetta creates as a
result of performing the Services for Prometheus.
2.4 Laboratory Location;
Visits. Unless otherwise agreed by Prometheus in writing, all Services to
be performed by Rosetta hereunder shall be performed at its licensed laboratory
facility located at 0000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxxxxx, XX 00000 (the
“Licensed
Facility”), provided that Rosetta shall have the right to change the
location of the Licensed Facility to a substantially equivalent and
appropriately licensed laboratory facility within the United States upon one
hundred thirty-five (135) days’ prior written notice to
Prometheus. Prometheus’ designated representatives may visit the
Licensed Facility upon reasonable advance notice and with reasonable frequency
to observe the performance of the Services and to ensure compliance with this
Agreement. Such Prometheus representatives shall be subject to and
bound by the applicable confidentiality obligations set forth in Section
6.1.
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.
CONFIDENTIAL
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3.
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PERSONNEL
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Rosetta
shall provide a sufficient number of qualified personnel to support Rosetta’s
obligations under this Agreement and to timely perform all Services in
accordance with this Agreement. Rosetta shall have the right, in its
sole discretion, to engage appropriately qualified, non-employee staff on a
contract basis to perform the Services at the Licensed
Facility. Rosetta shall not otherwise subcontract all or any portion
of the Services to any third party without Prometheus’ prior written
consent. Rosetta shall obtain all appropriate agreements (e.g.
non-disclosure and inventions assignment agreements) from its employees, agents
and contractors sufficient to ensure full compliance with all of the provisions
of this Agreement.
4.
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RECORDS
AND REPORTS
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4.1 Test
Results. Rosetta shall use commercially reasonable efforts to
furnish a report to Prometheus providing the data and results of the applicable
Diagnostic Test as specified in the SOP (the “Test Results”) within
[***] of the delivery of each Laboratory Sample to Rosetta (with Laboratory
Samples received by Rosetta after 12 noon being treated as having been delivered
on the following business day), subject to the limit on the number of Laboratory
Samples to be processed in any single business day as set forth in Section
2.1. Each Laboratory Sample will be supplied to Rosetta in two (2)
collection tubes containing the tissue to be tested. If,
having started to run the Diagnostic Test on the first tube, Rosetta determines
that the tissue in the first tube is not adequate to complete the Diagnostic
Test, Rosetta shall so notify Prometheus in accordance with the SOP, and Rosetta
shall be entitled to an extension of an additional [***] to provide the Test
Results using the second tube. All Test Results shall be branded by
Prometheus and shall be in the standard format of Rosetta unless otherwise
specified in the SOP, and shall be prepared in accordance with all
Laws. All Test Results, Laboratory Samples, slides and tissue shall
be owned by Prometheus and shall be Prometheus’ Confidential Information,
provided that Rosetta shall be entitled to retain a copy of all Test Results for
its records and to discuss the Test Results with Prometheus’ customers pursuant
to Section 2.2. Without prejudice to Section 10 hereof, Rosetta shall
maintain ownership of all physical copies of laboratory notebooks and other
original records of the work done to produce the Test Results and shall be
authorized to use and archive such items for purposes of regulatory compliance,
provided that Prometheus shall be entitled to retain a copy of all such
notebooks and records and use and disclose the same for Prometheus’ and its
Affiliates’ business purposes.
4.2 Records.
a) Rosetta
shall keep complete and accurate records of the status and progress of each
Diagnostic Test, as required by the SOP and all Laws, and shall maintain records
covering such Diagnostic Test and all other Services in compliance with all
Laws. Such records shall be owned by Rosetta and shall constitute
Prometheus Confidential Information, provided that Rosetta shall be entitled to
retain and use such records for the purpose of regulatory
compliance.
b) Each
Party hereto shall permit, and shall ensure that any subcontractor permits, the
United States Department of Health and Human Services and General Accounting
Office to review appropriate books and records relating to the performance
hereunder to the extent required under Section 1861(v)(1)(I) of the Social
Security Act, 42 U.S.C. Section 1395x(v)(1)(I), or any successor law or
regulation for a period of four (4) years following the last day such Party
provided services hereunder. The access shall be provided in
accordance with the provisions of 42 C.F.R. Part 420, Subpart D.
c) If
Rosetta carries out any of the duties of this Agreement through a subcontract,
with a value or cost
of Ten Thousand Dollars ($10,000) or more over a twelve (12) month period, with
a related organization, such subcontract shall contain a clause to the effect
that until the expiration of four (4) years after the furnishing of such
services pursuant to such subcontract, the related organization shall make
available, upon written request to the Secretary of the United States Department
of Health and Human Services or upon request to the Comptroller General of the
United States, or any of their duly authorized representatives, the subcontract,
and books, documents and records of such organization that are necessary to
verify the nature and extent of the costs incurred pursuant to such
subcontract.
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.
CONFIDENTIAL
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5.
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COMPENSATION
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5.1 Compensation. Prometheus
shall pay Rosetta in accordance with the pricing set forth in the fee schedule
attached hereto in Exhibit 1 (“Fee Schedule”) for
the applicable Diagnostic Test. Rosetta shall invoice Prometheus
pursuant to a single invoice at the beginning of each calendar month for all
Test Results provided by Rosetta during the prior calendar
month. Invoices are due and payable within thirty (30) days after
receipt by Prometheus, and Prometheus agrees to pay all invoices submitted provided that such
Services were performed by Rosetta in accordance with the SOP and are not the
subject of a bona fide dispute. All invoices and payments due
pursuant to this Agreement shall be in United States Dollars. Each
invoice shall be accompanied by a report specifying, for each Diagnostic Test
conducted in the prior month, the type, quantity, and price of each Diagnostic
Test conducted.
Any necessary and appropriate changes in the Fee Schedule for any Diagnostic
Test, as revised by amendments thereto, will be subject to written approval by
authorized representatives of Rosetta and Prometheus.
5.2 Delays. Rosetta
shall promptly notify Prometheus if it believes it will be delayed in the
provision of any Test Result by more than two (2) business days in excess of the
time specified in Section 4.1.
6.
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PRIVACY;
CONFIDENTIALITY
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6.1 Confidentiality. The
provisions of Section 6 of the License Agreement shall be deemed incorporated
herein, with references to the “Agreement” therein being construed as references
to this Agreement as well. Any Prometheus representatives that visit
the Licensed Facility will use reasonable efforts to avoid accessing or
observing any confidential information of Rosetta unrelated to the Services, or
any confidential information of Rosetta’s other licensees, collaborators or
customers, and shall follow all reasonable instructions of Rosetta’s personnel
with respect to such matters. In the event that Prometheus’ representatives do
access or observe any such confidential information, it shall be treated as
Rosetta Confidential Information; provided that notwithstanding anything to the
contrary in Section 6.1.1 of the License Agreement, Prometheus shall not be
entitled to use such information for any purpose or to disclose it to any other
of its employees, Affiliates, contractors, Sublicensees or third party except as
expressly stated in Section 6.1.3 of the License Agreement.
6.2 Privacy. The
Parties acknowledge the applicability of the privacy standards as set forth in
the Health Insurance Portability and Accountability Act of 1996, Public Law
104-191 ("HIPAA") and all
regulations promulgated thereunder by the U.S. Department of Health and Human
Services, including 45 C.F.R. §§ 164.500-164.534 (the "Privacy Rule ") and
164.302-164.318 (the "Security Standards")
as the same may be amended from time to time, and agree that each will comply
with their respective obligations as required by HIPAA and any other applicable
privacy laws. Further, the Parties agree to take all other reasonable
steps to protect the confidentiality of any patient health and medical
information in compliance with all Laws.
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.
CONFIDENTIAL
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7.
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USE
OF NAMES
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Neither
Party will use the other Party’s name or the name of any employee of the other
Party in any advertising, packaging, or promotional material, except as required
or permitted under the License Agreement or agreed in writing by the
Parties.
8.
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WARRANTIES
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Rosetta
hereby represents and warrants that:
8.1 the
Services provided to Prometheus in connection with each Diagnostic Test
conducted under this Agreement shall conform to the SOP for such Diagnostic Test
(unless otherwise agreed by the Parties in writing) and shall be in compliance
with all Laws; provided, however, that Rosetta makes no representation and gives
no warranty that the Diagnostic Tests may be performed in compliance with Law on
Laboratory Samples obtained in New York, Florida, Maryland or California until
such time as Rosetta’s pending state license applications in such states
issue. Rosetta shall use commercially reasonable efforts to obtain
all licenses in New York, Florida, Maryland and California which are necessary
to in order perform the Services with respect to Laboratory Samples collected in
such states. Rosetta shall promptly notify Prometheus upon the
issuance of each such state license and thereafter Rosetta shall maintain such
state license in good standing for the remainder of the Term. Rosetta shall not
perform any Diagnostic Tests on any Laboratory Samples obtained from states
where it is not properly licensed to provide the Services; provided, however,
that Rosetta shall be entitled to rely on the information supplied by Prometheus
or its customers as to the state in which a given Laboratory Sample has been
obtained.
8.2 the
Licensed Facility is, and at all times during the Term shall be, licensed or
certified according to all applicable Laws. Rosetta shall provide
Prometheus with a copy of each of Rosetta’s licenses and certifications upon
request; and
8.3 it
is not now nor has it ever been sanctioned, debarred, suspended, or excluded
from participation in any federally funded health care program, including
Medicare or Medicaid, and agrees that it shall notify Prometheus in the event of
any adverse action relating to its license, permit, certification or right to
receive reimbursement from any federally funded health care program, including
Medicare and Medicaid.
9.
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INDEMNITIES
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9.1 Indemnification by
Rosetta. Rosetta shall indemnify, defend and hold harmless
Prometheus and its officers, directors, employees, agents and representatives
(“Prometheus
Indemnitees”) from and against any and all liabilities, claims, demands,
actions, suits, losses, damages, fines, sanctions, costs and expenses (including
reasonable attorneys’ fees) arising from third party claims, including
investigations or actions by any government agency, to the extent based upon or
arising out of Rosetta’s negligence, willful or deliberate misconduct,
recklessness or Rosetta’s breach of any covenant, agreement, representation or
warranty made by Rosetta in this Agreement; provided, however, that Rosetta
shall not be required to indemnify a Prometheus Indemnitee to the extent such
claims arise from the negligence, willful or deliberate misconduct, or
recklessness of a Prometheus Indemnitee or Prometheus’ breach of this
Agreement.
9.2 Indemnification by
Prometheus. Prometheus shall indemnify, defend and hold
harmless Rosetta and its officers, directors, employees, agents and
representatives (“Rosetta Indemnitees”)
from and against any and all liabilities,
claims, demands, actions, suits, losses, damages, fines, sanctions, costs and
expenses (including reasonable attorneys’ fees) arising from third party claims,
including investigations or actions by any government agency, to the extent
based upon or arising out of Prometheus’ negligence, willful or deliberate
misconduct, recklessness or Prometheus’ breach of any covenant, agreement,
representation or warranty made by Prometheus in this Agreement; provided,
however, that Prometheus shall not be required to indemnify a Rosetta Indemnitee
to the extent such claims arise from the negligence, willful or deliberate
misconduct, or recklessness of a Rosetta Indemnitee or Rosetta’s breach of this
Agreement.
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.
CONFIDENTIAL
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9.3 Indemnification
Procedure. The provisions of Section 8.3 of the License Agreement shall
be deemed incorporated herein, with references to the “Agreement” therein being
construed as references to this Agreement as well.
10.
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OWNERSHIP
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10.1 Ownership of Prometheus
IP. Subject to any provision to the contrary in the License
Agreement or this Agreement, all intellectual property rights in any materials,
processes, inventions and/or discoveries relating to Prometheus’ performance
under this Agreement, shall remain the sole and exclusive property of Prometheus
(the “Prometheus
IP”) and shall be subject to any licenses applicable thereto under the
License Agreement.
10.2 Ownership of Rosetta
IP. Subject to any provision to the contrary in the License Agreement or
this Agreement, all intellectual property rights in any inventions and/or
discoveries relating to Rosetta’s performance of the Services, including all
testing methods and processes employed by Rosetta, and whether created outside
of or during the course of Rosetta’s performance of the Services, are and shall
remain the sole and exclusive property of Rosetta (the “Rosetta IP”) and
shall be subject to any licenses applicable thereto under the License
Agreement.
11.
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INSURANCE
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Without
limiting Section 8.4 (Insurance) of the License Agreement, each Party shall
carry insurance sufficient to cover its interest or liabilities hereunder
including, but not limited to worker’s compensation and comprehensive general
liability. At a minimum, each Party shall obtain and maintain in
force during the term of this Agreement, comprehensive general liability
insurance in the amount of [***] per occurrence and [***] in the annual
aggregate plus professional liability insurance in the amount of [***] per
occurrence and [***] in the aggregate.
12.
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TERM
AND TERMINATION
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12.1 Term. Unless
earlier terminated by the Parties as set forth below, this Agreement will
commence on the Effective Date and will continue for one (1) year and from year
to year thereafter unless terminated as set forth herein (the “Term”).
12.2 Termination for
Convenience. Prometheus shall have the right to terminate the
Services in their entirety or with respect to any one or more Diagnostic Tests
at any time without cause upon sixty (60) days prior written notice to
Rosetta. Rosetta shall have the right to terminate the Services in
their entirety or with respect to any one or more Diagnostic Tests at any time
without cause upon ninety (90) days prior written notice to Prometheus, to be
given no earlier than ninety (90) days prior to the third (3rd)
anniversary of the Effective Date.
12.3 Termination for
Breach. Either Party may terminate this Agreement at any time
upon sixty (60) days prior written notice to the other Party (or thirty (30)
days in the case of a breach consisting of a failure by a Party to make timely
payment of any amount that is not the subject a bona fide dispute and is due
under this Agreement pursuant to a properly rendered invoice), for material
breach of this Agreement by the other Party where such breach is not remedied to
the non-breaching Party’s reasonable satisfaction within the applicable notice
period.
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.
CONFIDENTIAL
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12.4 Termination upon Termination
of License Agreement. This
Agreement shall automatically terminate in the event that the License Agreement
is terminated pursuant to its terms.
12.5 Consequences of
Termination. Upon termination of this Agreement for any
reason, Rosetta shall complete the performance of any Diagnostic Tests
previously ordered by Prometheus and/or its customers and shall submit a final
invoice to Prometheus. Prometheus shall pay such final invoice in
accordance with Section 5.1 and otherwise comply with all terms and conditions
of this Agreement relating to such Diagnostic Tests and payment therefor as if
the Agreement were still in force.
12.6 Survival. Upon
expiration or termination of this Agreement, neither Party will have any further
obligations under this Agreement, except that (i) the liabilities, including for
payment, accrued through the date of termination and (ii) Article and Sections
4.2 (Records), 6 (Privacy; Confidentiality), 9 (Indemnity), 10 (Ownership), 11
(Insurance), 12.5 (Consequences of Termination), 12.6 (Survival), 13 (Dispute
Resolution) and 14 (Miscellaneous) shall survive the expiration or termination
of this Agreement.
13.
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EXCLUSIONS
OF LIABILITY; DISPUTE RESOLUTION
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13.1 EXCEPT
WITH RESPECT TO ANY INDEMNIFICATION OBLIGATION OWED WITH RESPECT TO A THIRD
PARTY LOSS, A BREACH OF ARTICLE 6 (PRIVACY, CONFIDENTIALITY), NEITHER PARTY
SHALL BE LIABLE (NOR SHALL ITS LICENSORS BE LIABLE) TO THE OTHER PARTY UNDER ANY
CIRCUMSTANCES OR ANY LEGAL OR EQUITABLE THEORY, WHETHER IN CONTRACT, STRICT
LIABILITY OR OTHERWISE, FOR ANY CONSEQUENTIAL DAMAGES EVEN IF ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY
FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED REMEDY. NOTWITHSTANDING
THE FOREGOING, THESE LIMITATIONS SHALL NOT APPLY TO ANY THIRD-PARTY CLAIM THAT
IS THE SUBJECT OF SECTION 9, TO THE EXTENT SUCH THIRD PARTY HAS BEEN AWARDED
SUCH DAMAGES. NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, THIS
SECTION 13.1 SHALL IN NO WAY LIMIT EITHER PARTY’S RIGHTS TO SEEK AND/OR OBTAIN
DIRECT DAMAGES, INCIDENTAL DAMAGES AND/OR LOST PROFITS, PROVIDED THAT IN NO
EVENT SHALL ROSETTA BE LIABLE FOR THE COSTS OF SETTING UP A SUBSTITUTE
LABORATORY TO CONDUCT THE DIAGNOSTIC TESTS, WHETHER SUCH COSTS ARE CHARACTERIZED
AS INCIDENTAL OR DIRECT DAMAGES OR ANY OTHER FORM OF DAMAGES.
13.2 The
provisions of Sections 11 of the License Agreement shall be deemed incorporated
herein, with references to the “Agreement” therein being construed as references
to this Agreement as well.
14.
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MISCELLANEOUS
|
14.1 Notices. The
provisions of Section 12.8 of the License Agreement shall be deemed incorporated
herein, with references to the “Agreement” therein being construed as references
to this Agreement as well
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.
CONFIDENTIAL
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14.2 Independent
Contractors. The business relationship of Rosetta and
Prometheus established by this Agreement is that of independent contractors, and
nothing contained in this Agreement shall be construed to (i) give either Party
the power to direct or control the day-to-day activities of the other, (ii)
constitute the Parties as partners, joint venturers, employer, employee,
co-owners or otherwise as participants in a joint or common undertaking, or
(iii) allow either Party to create or assume any obligation on behalf of the
other Party for any purpose whatsoever.
14.3 Assignment;
Headings. This Agreement,
and the rights and obligations hereunder, may not be assigned or transferred by
either Party without the prior written consent of the other Party; provided,
however, without such written consent either Party may assign this Agreement in
connection with the transfer or sale of all or substantially all of its assets
or business to which this Agreement relates or its merger or consolidation with
another company, provided that such successor is bound by the terms of this
Agreement. Headings and captions in this Agreement are for
convenience only and are not to be used in the interpretation of this
Agreement.
14.4 Right of Set-Off. Notwithstanding
anything to the contrary in this Agreement, Prometheus shall have a right to
set-off any amounts due under this Agreement only against any damages incurred
by Prometheus and/or its Affiliates under this Agreement, subject to the
obligations under Section 11.3 of the License Agreement.
14.5 Entire Agreement. This Agreement
and the License Agreement, together with all attached Annexes and Schedules
contain the entire understanding between the Parties relating to the subject
matter hereof and supersede any and all prior agreements, understandings and
arrangements, whether written or oral, between the Parties relating to such
subject matter and to the extent relating to the Services. In the
event that there is a conflict between any provision of the License Agreement
and any provision of this Agreement, the License Agreement shall
prevail. No amendments, changes, modifications, waivers or
alterations of the terms and conditions of this Agreement shall be binding upon
either Party unless in writing and signed by both Parties.
14.6 Unenforceability. Both
Parties hereby expressly state that it is the intention of neither Party to
violate any Law. If any of the provisions of this Agreement are held
to be void or unenforceable, then the Parties shall use good faith efforts for a
period of no more than ten (10) business days to replace such void or
unenforceable provisions with valid and enforceable provisions which will
achieve as far as possible the economic business intentions of the Parties,
failing which, such void or unenforceable provisions shall be deemed to be
severed from this Agreement without replacement.
14.7 Non-Exclusive
Agreement. Except as otherwise set forth in the License
Agreement, this Agreement is not exclusive. Accordingly, Prometheus
and Rosetta shall have the right to enter into one or more agreements relating
to the same or similar matters as are covered by this Agreement, and execution
by Prometheus and Rosetta of such agreements shall not constitute a breach of
this Agreement.
14.8 Governing Law;
Counterparts. This Agreement
will in all events and for all purposes be governed by, and construed in
accordance with, the laws of the State of New York, without regard to any choice
of law principle that would dictate the application of the law of another
jurisdiction. This Agreement may be executed in multiple
counterparts, each of which shall be deemed an original, but both of which
together will constitute one and the same instrument.
14.9 Force
Majeure. A “Force Majeure Event”
shall mean any cause or contingency beyond a Party’s reasonable control which is
not reasonably preventable by taking precautions which are customary and/or
prudent for a company and/or facility the size of that being operated by the
affected Party (the Parties agree that such precautions shall not include
maintaining a back-up laboratory facility), including, strikes or other labor
disturbances, lockouts, riots, quarantines, communicable disease outbreaks,
wars, acts of terrorism, fires, floods, storms, or compliance with any order or
regulation of any Regulatory Authority acting within color of right and any
circumstances caused by the other Party or, in the case of Prometheus and its
Affiliates, their respective customers or any entity in their chain of
distribution. If and to the extent that either Party is prevented or delayed by
a Force Majeure Event from performing any of its obligations under this
Agreement and promptly so notifies the other Party, specifying the matters
constituting the Force Majeure Event together with such evidence in verification
thereof as it can reasonably give and specifying the period for which it is
estimated that the prevention or delay will continue, then the Party so affected
shall be relieved of liability to the other for failure to perform or for delay
in performing such obligations (as the case may be), but shall nevertheless use
commercially reasonable efforts to resume full performance thereof, provided
that if the Force Majeure Event continues for a period of ninety (90) days or
more following notification, the Party whose performance is not affected by the
Force Majeure Event may terminate this Agreement by giving not less than thirty
(30) days prior notice to the other 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.
CONFIDENTIAL
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In
Witness Whereof, duly authorized representatives of the Parties have
signed this Agreement
as of the Effective Date.
ROSETTA
GENOMICS INC.
By:
/s/ Xxxx
Xxxxxx
Name:
Xxxx Xxxxxx
Title:
CEO
PROMETHEUS
LABORATORIES INC.
By:
/s/ Xxxxxx X.
Xxxxxx
Name: Xxxxxx
X. Xxxxxx
Title: President
and Chief Executive Officer
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.
Signature
Page to Laboratory Services Agreement
CONFIDENTIAL
Exhibit
1
Fee
Schedule
Squamous Test: | US $[***] | |
METS Test: | US $[***] | |
Mesothelioma Test: | US $[***] |
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.
CONFIDENTIAL
Exhibit
2
Disclaimers
and Collection Instructions
Prometheus
diagnostic services provide important information to aid in the diagnosis and
management of certain diseases and conditions. How this information
is used to guide patient care is the responsibility of the
physician.
Specimen
Instructions
The
specimen collection instructions are attached hereto. Such specimen
collection instructions may not be modified by either party without the prior
written consent of the other party, such consent not to be unreasonably
withheld, provided that Prometheus shall have the right to make non-substantive
modifications without the prior consent of Rosetta.
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.
CONFIDENTIAL