Exhibit 10.28
EXECUTION COPY
PROCESS DEVELOPMENT
AND
CLINICAL SUPPLY
AGREEMENT
This Clinical Supply Agreement (the “
Agreement ”) is made as of June 30, 2004, (the “
Effective Date ”) by and among Cambrex Bio Science
Walkersville, Inc., a Delaware corporation (“ CBSW
”), Smith & Nephew Wound Management (La Jolla), a
Delaware partnership (“ SNWMLJ ”), Inamed
Medical Products Corporation, a California corporation (“
Inamed ”), and SkinMedica, Inc., a Delaware
corporation (“ SkinMedica ”, and each of SNWMLJ,
Inamed or SkinMedica individually referred to as “
Client ” and collectively referred to as “
Clients ”, and each of CBSW and Clients individually
referred to as “ Party ” and collectively
referred to as the “ Parties ”).
RECITALS
A. CBSW operates a multi-client
production facility located at 8830 Biggs Ford Road, Walkersville,
Maryland 21793 (the “ Facility ”).
B. Clients desire to have CBSW
develop one or more processes to produce cell banks containing
human cells and intended for therapeutic use in humans, and
thereafter to produce such cell banks, and CBSW desires to develop
such process and produce such cell banks.
NOW, THEREFORE, in consideration of
the foregoing and the mutual promises and covenants hereinafter set
forth, CBSW, SNWMLJ, Inamed and SkinMedica, intending to be legally
bound, hereby agree as follows:
AGREEMENT
1. D EFINITIONS
When used in this Agreement,
capitalized terms will have the meanings as defined below and
throughout the Agreement. Unless the context indicates otherwise,
the singular will include the plural and the plural will include
the singular.
1.1 “ Affiliate ” means a legal
entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common
control with a Party. For purposes of this definition only,
“control” and, with correlative meanings, the terms
“controlled by” and “under common control
with” means (a) the possession, directly or indirectly, of
the power to direct the management or policies of a legal entity,
whether through the ownership of voting securities or by contract
relating to voting rights or corporate governance, or (b) the
ownership, directly or indirectly, of more than 50% of the voting
securities or other ownership interest of a legal entity;
provided, however , that if local law restricts foreign
ownership, control will be established by direct or indirect
ownership of the maximum ownership percentage that may, under such
local law, be owned by foreign interests.
1.
EXECUTION COPY
1.2 “ Batch ” means a specific
quantity of Product that is intended to have uniform character and
quality, within specified limits, and is produced according to a
single manufacturing order during the same cycle of
manufacture
1.3 “ Batch Record ” means the
production record pertaining to a Batch.
1.4 “ CBSW Inventions ” means any
know-how, media, assays, methods or other inventions, whether or
not patentable, conceived, developed or reduced to practice by
CBSW: (a) on or before the Effective Date; or (b)(i) in connection
with the performance of the Development Plan or the Production
Plan, and (ii) relating generally to CBSW’s business of
producing biological materials; but excluding any Client
Inventions.
1.5 “ CBSW Operating Documents ”
means the standard operating procedures, standard manufacturing
procedures, raw material specifications, protocols, validation
documentation, and supporting documentation, such as environmental
monitoring, for operation and maintenance of the Facility and CBSW
equipment used in the process of producing the Product, excluding
any of the foregoing that are unique to the manufacture of
Product.
1.6 “ CBSW Parties ” has the
meaning set forth in Section 14.1.
1.7 “ cGMP ” means current Good
Manufacturing Practices as contained in 21 CFR Parts 210 and 211 as
amended from time to time.
1.8 “ Change Order ” has the
meaning set forth in Section 2.2.
1.9 “ Client Development Materials
” has the meaning set forth in Section 2.3.
1.10 “ Client Inventions ” means:
(a) any know-how or inventions, whether or not patentable,
conceived, developed or reduced to practice by one or more Clients
(i) on or before the Effective Date, or (ii) in connection with the
performance of the Development Plan or the Production Plan; and (b)
any patentable inventions conceived, developed or reduced to
practice by CBSW, solely or jointly with one or more Clients,
directly in the course of performance of the Development Plan or
Production Plan and relating to Product and/or the manufacture or
use thereof, including, without limitation, the Process and any
related Master Production Record (excluding any CBSW Operating
Documents or CBSW Confidential Information included
therein).
1.11 “ Client Materials ” means
the Client Development Materials and the Client Production
Materials.
1.12 “ Client Personnel ” has the
meaning set forth in Section 3.8.1
1.13 “ Client Production Materials
” has the meaning set forth in Section 3.2.
1.14 “ Commencement Date ” means
the date set forth in the Production Plan for the commencement of
the production of the Product.
2.
EXECUTION COPY
1.15 “ Development Plan ” has the
meaning set forth in Section 2.1.
1.16 “ FDA ” means the U.S. Food
and Drug Administration, and any successor agency
thereof.
1.17 “ Lead Time ” has the meaning
set forth in the Production Plan.
1.18 “ Master Production Record ”
means the documentation developed jointly by CBSW and Clients that
contains a detailed description of the Process, Materials,
Chemicals, Equipment, Aids and any other instructions to be
followed by CBSW in the production of the Product.
1.19 “ Materials ” means all raw
materials and supplies to be used in the production of the
Product.
1.20 “ Monthly Fee ” has the
meaning set forth in Schedule 8.1, attached hereto and hereby
incorporated herein by reference.
1.21 “ Process ” means the
manufacturing process for the Product pursuant to the terms of this
Agreement.
1.22 “ Product ” has the meaning
set forth in Schedule 1.22 attached hereto and hereby incorporated
herein by reference.
1.23 “ Product Unit ” has the
meaning set forth in Schedule 1.22.
1.24 “ Product Warranties ” means
those warranties as specifically stated in Section 4.1.
1.25 “ Production Plan ” has the
meaning set forth in Section 3.1.
1.26 “ Production Suite ” means a
production facility and associated common space that is validated
and meets FDA standards and applicable guidelines.
1.27 “ Production Term ” means the
period commencing on the Commencement Date and terminating on the
date of expiration or termination of this Agreement.
1.28 “ Regulatory Approval ” means
the approval by the FDA to market and sell the Product in the
United States.
1.29 “ SOP ” means a standard
operating procedure.
1.30 “ Specifications ” means the
Product specifications set forth in Schedule 1.22 attached hereto,
or as modified by the Parties in connection with the production of
a particular Batch of Product hereunder.
1.31 “ Third Party ” means any
party other than CBSW, Clients or their respective
Affiliates.
3.
EXECUTION COPY
2. P ROCESS D EVELOPMENT
2.1 Development Plan
. If development of the Process is
to be performed by CBSW, the Parties will collaborate to develop a
final plan describing the activities to be performed by the
Parties, or to be subcontracted by CBSW to Third Parties, in the
development of the Process and the Master Production Record (the
“ Development Plan ”). A draft outline of the
Development Plan is included in Schedule 2.1. The final Development
Plan will be binding on the Parties if and when signed by all
Parties. If development of the Process is to be performed by CBSW
under the terms of this Agreement and the Parties are unable to
agree on a final Development Plan within 90 days after the
Effective Date, any Party may terminate this Agreement by written
notice effective upon receipt.
2.2 Modification of Development
Plan . Should Clients
want to change the Development Plan or to include additional
services to be provided by CBSW, Clients may in a written notice
executed by each of them propose to CBSW an amendment to the
Development Plan with the desired changes or additional services
(“ Change Order ”). If CBSW determines that it
has the resources and capabilities to accommodate such Change
Order, CBSW will prepare a modified version of the Development Plan
reflecting such Change Order and will submit such modified version
of the Development Plan to Clients for review and comment. The
modified Development Plan shall be binding on the Parties only if
signed by all Parties, whereafter such modified version of the
Development Plan will be deemed to have replaced the prior version
of the Development Plan.
2.3 Client
Deliverables . Within the
time period specified in the Development Plan, Clients will provide
CBSW with (a) the materials listed in the Development Plan, and any
handling instructions, protocols, SOPs and other documentation
necessary to maintain the properties of such materials for the
performance of the Development Plan or the Production Plan, and (b)
any protocols, SOPs and other information and documentation in
possession or control of Clients and necessary for the performance
of the Development Plan, the preparation of the Master Production
Record, and the manufacture of Product pursuant to the Master
Production Record in conformance with cGMP, including, without
limitation, process information, SOPs, development data and
reports, quality control assays, raw material specifications
(including vendor, grade and sampling/testing requirements),
product and sample packing and shipping instructions, and product
specific cleaning and decontamination information, (collectively,
the “ Client Development Materials
”).
2.4 Performance by
CBSW . Subject to the
provision by Clients of the Client Development Materials pursuant
to Section 2.3, CBSW will use commercially reasonable efforts to
perform, directly or, subject to written approval by each of the
Clients (such approval not to be unreasonably withheld), through a
Third Party contractor, the Development Plan in a professional and
workmanlike manner in accordance with the terms of this Agreement.
CBSW will use commercially reasonable efforts promptly to notify
Clients of any material delays that arise during the performance of
the Development Plan.
4.
EXECUTION COPY
2.5 Master Production
Record.
2.5.1 Based on the Process developed by CBSW and
Clients pursuant to the Development Plan, CBSW will prepare the
Master Production Record for the Process. Clients will inform CBSW
of any specific requirements Clients may have relating to the
Master Production Record, including, without limitation, any
information or procedures Clients wish to have incorporated
therein. If CBSW intends to include in the Master Production Record
the use of any assay, medium, or other technology that is not
commercially available, CBSW will inform Clients of such intention
and the Parties will meet to discuss and attempt to agree in good
faith on the terms of use of such non-commercially available
materials or technology in the Process.
2.5.2 Clients will cooperate with CBSW to assist CBSW
to develop the Master Production Record and Process, including,
without limitation, by providing CBSW with additional information
and procedures as may be required to create the Master Production
Record, Process, and/or any of the following: (i) manufacturing
process information, SOPs, development reports, (ii) quality
control assays, (iii) raw material specifications (including
vendor, grade and sampling/testing requirements), (iv) Product and
sample packing and shipping instructions, (v) Product specific
cleaning and decontamination information, (vi) Product
Specifications.
2.5.3 CBSW will deliver a draft version of the Master
Production Record to Clients for review and approval, within the
time period specified in the Development Plan. Clients will notify
CBSW in writing of any objections to the Master Production Record,
and upon such notification, representatives of CBSW and Clients
will meet promptly to resolve such objections.
2.5.4 The Process, Master Production Record,
Specifications, and any improvements or modifications thereto
developed during the term of this Agreement, but excluding any CBSW
Operating Documents or CBSW Confidential Information included in
any of the foregoing, will be deemed Confidential Information of
Clients and subject to the provisions set forth in Section 9. Each
of the Clients has the right to use (itself or through a Third
Party) the Process and/or the Master Production Record, conditioned
on the following: such Client and any such Third Party must agree
in writing to protect CBSW Confidential Information contained
therein and such Client’s and/or any such Third Party’s
use shall be limited to uses related to Product.
3. M ANUFACTURE O F P RODUCT ; O RDER P ROCESS ; D ELIVERIES
3.1 Production Plan
. Together with the draft version
of the Master Production Record described in Section 2.5.3 above,
CBSW will deliver to Clients for review and comment, a proposed
final plan describing the activities to be performed by CBSW, or to
be subcontracted by CBSW to Third Parties, in the production of the
Product (the “ Production Plan ”). CBSW will
deliver the proposed final Production Plan within the time period
set forth in Schedule 3.1. A draft outline of the Production Plan
is included in Schedule 3.1, attached hereto and hereby
incorporated herein by reference. The final Production Plan will be
binding on the Parties if and when signed by all Parties. If the
Parties are unable to agree on a final Production Plan within 90
days after the time period specified in Schedule 3.1 for the first
submission of such plan by CBSW to Clients, Clients may
collectively agree to terminate this Agreement by written notice
signed by each of them effective upon receipt by CBSW.
5.
EXECUTION COPY
3.2 Client
Deliverables. Within the
time period specified in the Production Plan, Clients will provide
CBSW with (a) the materials listed in the Production Plan required
for the production of the Product, and any handling instructions,
protocols, SOPs and other documentation necessary to maintain the
properties of such materials for the performance of the Production
Plan (collectively, the “ Client Production Materials
”).
3.3 Commencement Date
. The Production Plan will include a
Commencement Date agreed upon by the Parties.
3.4 Forecasting and Order
Process . A development
and production timeline for delivery of Product will be jointly
developed with CBSW and Clients. Commercially reasonable efforts on
the part of the Parties will be made to deliver on the dates set
forth in the Development Plan and Production Plan.
3.5 Manufacture by
CBSW . During the
Production Term, CBSW will use commercially reasonable efforts to
manufacture, package, ship, handle quality assurance and quality
control for the Product, all as set forth in the Production Plan,
and to deliver to Clients the quantities of Product requested by
Clients pursuant to Section 3.4, all in accordance with the terms
set forth in Section 3.6 below.
3.6 Packaging and
Shipping . CBSW will
package and label the Product for shipment in accordance with the
Master Production Record and CBSW’s standard practices in
effect at the time of performance by CBSW. CBSW will ship the
Product FCA (Incoterms 2000) delivered at the Facility to a common
carrier designated by Clients to CBSW in writing not less than ten
days prior to scheduled delivery date set forth in the applicable
order submitted pursuant to Section 3.4. Clients will provide to
CBSW one or more account numbers with the selected carrier and will
pay for all shipping costs in connection with each shipment of
Product. Each shipment will be accompanied by the documentation
listed in the Production Plan. CBSW will use commercially
reasonable efforts to deliver each shipment of Product to Clients
(or the designated individual Client agreed to by the Clients) on
the requested delivery date for such shipment. Should CBSW at any
time during the term of this Agreement have reason to believe that
it will be unable to meet a delivery date, CBSW will promptly
notify each of the Clients.
3.7 Records
. CBSW will maintain accurate
records for the production of the Product, as required by
applicable laws and regulations. CBSW will retain possession and
ownership of the Master Production Record, all Batch Records and
CBSW Operating Documents, and will make copies thereof available to
Clients upon any Client’s request and at the requesting
Client’s expense. CBSW Operating Documents will remain CBSW
Confidential Information. Clients will have the right to use and
reference any of the foregoing in connection with a filing for
Regulatory Approval of the Product or as otherwise authorized by
the Agreement.
3.7.1 Accessibility . All documents developed
and produced by one or more Clients and CBSW or documents that have
been jointly developed by the Parties
6.
EXECUTION COPY
relating to or used in the preparation or
production of Product shall be accessible and provided to Clients
and, upon written request from each of the Clients or pursuant to
applicable law, to a Third Party (examples: Regulatory agency,
partner of SNWMLJ). However, if such documents are given to a Third
Party other than a regulatory agency, any such Third Party must
agree in writing to protect CBSW Confidential Information contained
therein, and each Client’s and/or any such Third
Party’s use shall be limited to uses related to Product. One
(1) year after the Effective Date, the reasonable cost of providing
accessibility of the documentation to any Third Party other than a
regulatory agency shall be passed through to the Client requesting
such access.
3.7.2 Retention
. All documents used in the
production of Product will be maintained and retained by CBSW for a
minimum time period of 30 years after manufacture of Product. Any
exceptions must be approved by each of the Clients in
writing.
3.8 C LIENT A CCESS .
3.8.1 Each Client’s employees and agents
(including its independent contractors) (collectively, “
Client Personnel ”) may participate in the production
of the Product in such capacities as may be approved in writing in
advance by CBSW. Client Personnel working at the Facility are
required to comply with CBSW’s Operating Documents and any
other applicable CBSW facility and/or safety policies.
3.8.2 Client Personnel working at the Facility will be
and remain employees of the applicable Client, and the applicable
Client will be solely responsible for the payment of compensation
for such Client Personnel (including applicable Federal, state and
local withholding, FICA and other payroll taxes, workers’
compensation insurance, health insurance, and other similar
statutory and fringe benefits). The applicable Client covenants and
agrees to maintain workers’ compensation benefits and
employers’ liability insurance as required by applicable
Federal and Maryland laws with respect to all Client Personnel
working at the Facility.
3.8.3 The applicable Client will pay for the
reasonable cost of repairing or replacing (to the extent that CBSW
determines, in its reasonable judgment, that repairs cannot be
adequately effected) any property of CBSW damaged or destroyed by
its Client Personnel, provided such Client shall not be liable for
repair or replacement costs resulting from ordinary wear and
tear.
3.8.4 Client Personnel authorized to have access to
the Facility will abide by the security procedures established by
CBSW. The applicable Client will be liable for any breaches of
security by its Client Personnel. In addition, the applicable
Client will reimburse CBSW for the cost of any lost security cards
issued to its Client Personnel, at the rate of $50 per security
card. All Client Personnel will agree to abide by CBSW policies and
SOPs established by CBSW, and will sign a confidentiality agreement
in the then-current form used by CBSW.
3.9 Disclaimers
. Clients acknowledge and agree that
CBSW will not engage in any Product refinement or development of
the Product, other than as expressly set forth in this Agreement.
Clients acknowledge and agree that CBSW Parties have not
participated in the invention or testing of any Product, and have
not evaluated its safety or suitability for use in humans or
otherwise.
7.
EXECUTION COPY
3.10 Client Insurance
. Each Client will maintain, at all
times during the Term of this Agreement and for *** years
thereafter, a products liability insurance policy (the “
Insurance Policy ”) with limits of not less than ***
per occurrence, and will provide a Certificate of Insurance to CBSW
that the Insurance Policy has been endorsed to designate CBSW as an
additional named insured. Each Client will maintain the Insurance
Policy with an insurance company that is licensed to do business in
the State of Maryland and that is reasonably acceptable to CBSW.
Each Client must give at least 30 days’ prior written notice
to CBSW before the Insurance Policy can be terminated.
3.11 CBSW will maintain during the Term of this
Agreement and for *** years thereafter, a liability insurance
policy (the “ CBSW Insurance Policy ”) with
limits of not less than *** per occurrence, and will provide a
Certificate of Insurance to each Client that the Insurance Policy
has been endorsed to designate each Client as an additional named
insured. CBSW will maintain the CBSW Insurance Policy with an
insurance company that is licensed to do business in the State of
Maryland and that is reasonably acceptable to each Client. CBSW
must give at least 30 days’ prior written notice to each
Client before the Insurance Policy can be terminated.
4. P RODUCT W ARRANTIES ; A CCEPTANCE A ND R EJECTION O F P RODUCTS
4.1 Product Warranties
. CBSW warrants that any Product
manufactured by CBSW pursuant to this Agreement, at the time of
delivery pursuant to Section 3.6: (a) conforms to the
Specifications; (b) was manufactured in accordance with the Master
Production Record; and (c) was manufactured in accordance with
cGMP. Documentation demonstrating the above statement will be
provided at the request of any Client in the form of certificates
of conformance, certificates of analysis or other forms of
documentation reasonably requested by such Client.
4.2 Approval of
Shipment.
4.2.1 When a shipment of Product ordered by Clients
pursuant to Section 3.4 is ready for delivery, CBSW will notify
Clients and supply Clients with the required shipping documentation
set forth in the Production Plan. CBSW will not ship any shipment
of Product until the required shipping documentation for such
shipment has been approved in writing by each of the
Clients.
4.2.2 Clients will have *** after receipt of all
documentation specified in the Production Plan for each shipment of
Product (such period, the “ Acceptance Period ”)
to review such documentation. If any Client asserts that the
Product does not comply with the warranties set forth in Section
4.1 above (“ Product Warranties ”), such Client
will deliver to CBSW, in accordance with the notice provisions set
forth in Section 16.4 hereof, written notice of disapproval (the
“ Disapproval Notice ”) of such Product, stating
in reasonable detail the basis for such assertion of non-compliance
with the Product Warranties. If a valid Disapproval Notice is
received by CBSW during the Acceptance Period, then CBSW and
Clients will provide one another with all related paperwork and
records (including, but not limited to, quality control tests)
relating to both the production of the Product and the Disapproval
Notice.
|
***
|
Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
|
8.
EXECUTION COPY
4.2.3 If one or more Clients do not approve or
disapprove the shipment of Product , within the Acceptance
Period, CBSW will charge storage fees at the then current rate for
such Product. CBSW’s current storage rates are set forth in
Schedule 8.1.
4.3 Dispute
Resolution.
4.3.1 CBSW and Clients will attempt to resolve any
dispute regarding the conformity of a shipment of Product with the
Product Warranties. If such dispute cannot be settled within 45
days of the submission by each Party of such related paperwork and
records to the other Parties, and:
(a) if the Product is alleged not to conform with
the Product Warranties set forth in Section 4.1(a), then Clients
will submit a sample of the batch of the disputed shipment to an
independent testing laboratory of recognized repute selected by
Clients and approved by CBSW (such approval not to be unreasonably
withheld or delayed) for analysis, under Quality Assurance approved
procedures, of the conformity of such shipment of Product with the
Specifications. The costs associated with such analysis by such
independent testing laboratory will be paid by the Party whose
assessment of the conformity of the shipment of Product with the
Specifications was mistaken. The determination by the independent
testing laboratory, unless clearly erroneous, will be final and
binding on the Parties.
(b) If the Product is alleged not to conform with
the Product Warranties set forth in Section 4.1(b) or 4.1(c), such
dispute will be submitted to an arbitrator located in the state
where the Product is manufactured, with adequate scientific
background and training, and selected jointly by CBSW and Clients.
Such arbitrator, employing the Commercial Arbitration rules of the
American Arbitration Association, will determine whether the
Product is in non-conformance with the Product Warranties set forth
in Section 4.1(b) or 4.1(c), and such arbitrator’s findings,
unless clearly erroneous, will be final and binding on the Parties.
The costs and expenses associated with the retention of such
arbitrator will be shared equally by each Party that does not
prevail in the arbitration proceeding.
4.4 Remedies for Non-Conforming
Product.
4.4.1 In the event that the Parties agree, or an
independent testing laboratory or an arbitrator determines,
pursuant to Section 4.3, that a Batch of Product fails to conform
to the Product Warranties due to the failure of: (a) CBSW personnel
properly to execute the Master Production Record, (b) CBSW
personnel to comply with cGMP, (c) the Facility utilities, then
CBSW will initiate and produce, within three (3) months of a final
determination by either the Parties, the laboratory or the
arbitrator as to that Batch of Products’ failure to conform
to the Product Warranties, for Clients sufficient quantities of
Product to replace the non-conforming portion of such Batch of
Product (the “ Production Rerun ”), in
accordance with the provisions of this Agreement and at no
additional cost to Clients, or (d) CBSW to otherwise comply with
its the obligations under this Agreement.
9.
EXECUTION COPY
4.4.2 In the event that the Parties agree, or an
independent testing laboratory or an arbitrator determines,
pursuant to Section 4.3, that a Batch of Product fails to conform
to the Product Warranties for any reason other than as set forth in
Section 4.4.1, then CBSW will produce for Clients a Production
Rerun at Clients’ expense.
4.4.3 The Parties acknowledge and agree that after the
first *** consecutive attempts at replacement, Clients shall be
entitled to request that CBSW continue to perform Production Reruns
until Product is produced that conforms with the Product Warranties
or Clients may terminate the Agreement by providing written notice
executed by each of them to CBSW. Clients acknowledge and agree
that the remedies with respect to the failure of Product to conform
with any of the Product Warranties are the remedies as set forth in
this Section 4.4, and in furtherance thereof, Clients hereby waive
all other remedies at law or in equity regarding the foregoing
claims.
5. D AMAGE OR D ESTRUCTION OF M ATERIALS AND / OR P RODUCT
5.1 Remedies
. If during the manufacture of
Product pursuant to this Agreement, Product and/or Materials are
destroyed or damaged by CBSW Personnel, and such damage or
destruction resulted from CBSW’s failure to execute the
Process in conformity with the Master Production Record, then,
except as provided in Section 5.2 below, CBSW will provide Clients
with additional Product production time equal to the actual time
lost because of the destruction or damage of the Product and/or
Materials, without charging Clients a Monthly Fee for such
additional time and will replace such Product and/or Materials at
no additional cost to Clients. Clients acknowledge and agree that
the sole remedy with respect to damaged or destroyed Materials
and/or Product (except for the non-conformity of shipped Product
described in Section 4) is as set forth in this Section 5.1, and in
furtherance thereof, Clients hereby waive all other remedies at law
or in equity regarding the foregoing claims.
5.2 Limitations
. Notwithstanding anything to the
contrary set forth in the preceding Section 5.1, if during the
manufacture of Product pursuant to this Agreement, Product or
Materials are destroyed or damaged by CBSW Personnel while CBSW
Personnel were acting at the direction of Client Personnel and the
destruction or damage was a result of such direction, then CBSW
will have no liability to any Client as the result of such
destruction or damage.
5.3 Dispute Resolution
. CBSW and Clients will attempt to
resolve any dispute including the liability of CBSW under Section
5.1 or 5.2, but if such dispute cannot be settled within 30 days
after the occurrence of the applicable damage or destruction, then
the dispute will be submitted to an arbitrator located in Maryland,
with the requisite scientific background and training, and selected
jointly by CBSW and Clients. Such arbitrator, employing the
C
