EXHIBIT 6.09
This Repair and Service Agreement between SeaMED, a Plexus company (SeaMED), a
Washington Corporation with its principal place of business at 21621 30th Avenue
SE, Bothell, Washington and Biofield Corp. (Biofield), a Delaware corporation
with its principal place of business at 1025 Nine North Drive Ste. M,
Alpharetta, Georgia, is effective for the period May 1, 2000 to May 1, 2001.
This agreement will automatically renew for additional one-year periods unless
written notice, within 90 days of the end of term, by either party provides
notice of non-renewal. This Agreement shall cover all repair services provided
by SeaMED to Biofield. If any term of this Agreement conflicts with any term of
an issues purchase order, this Agreement shall take precedence. Any terms or
conditions in a new purchase order, not covered under this Agreement, must be
specified on such purchase orders or their attachments and must be mutually and
explicitly agreed to by both Biofield and SeaMED.
I. DEFINITIONS
A. "Service" shall be defined as labor and parts provided by SeaMED
to repair, or otherwise bring, a Product to current
specifications, as requested by Biofield and the effective SeaMED
documents.
B. "Product" shall be defined as each Product which is purchased by
Biofield from SeaMED under the current Manufacturing Supply
Agreement.
C. "Warranty Period" shall be defined as the period commencing upon
time of invoice to Biofield from SeaMED for each Product and
continuing for the period of time specified in the Manufacturing
Supply Agreement.
D. "Upgrade Warranty Period" shall be defined as the period
commencing upon time of invoice to Biofield from SeaMED, and
continuing for ninety (90) days thereafter, for each upgraded
Product.
E. "Service Warranty Period" shall be defined as the period
commencing upon time of invoice to Biofield from SeaMED, and
continuing for ninety (90) days thereafter, for each Product
services.
II. WARRANTY SERVICE COVERAGES
A. Under the terms of the Manufacturing Supply Agreement all
Products manufactured by SeaMED are warranted, for a period of 15
months from the Product ship date from Biofield's facility to
Biofield's customer, to be free from defects in material and
workmanship. They shall conform to applicable specifications,
drawings, samples and descriptions referred to in the
Manufacturing Supply Agreement (provided that shipment to
customer occurs within 3 months from date of original invoice to
Biofield per the Manufacturing Supply Agreement).
B. Biofield requested Product upgrades during the warranty period
fall into the original warranty period and do not extend the
warranty (except as may be covered by the 90 day upgrade
warranty).
C. Products in the warranty period that have received damage by
other than normal usage will be treated as out of warranty.
D. Products returned with warranty stickers removed, damaged or
broken will be treated as out
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of warranty, unless previous authorization in writing from the
SeaMED Service department utilizing the attached "Request Form,
Supplier Service Authorization".
E. Post-Termination Warranty Obligations - Following termination of
this Agreement, the provisions of this Agreement applicable to
SeaMED's obligation in providing warranty service for any
warranty period shall be deemed to continue in full force and
effect with respect to any and all Products throughout their
entire warranty period.
III. LOGISTICS
SeaMED and Biofield agree that in the event Biofield requests repair
services on any Product, such requests for service or repair shall be
initiated by Biofield by way of telephone, fax or e-mail to SeaMED
Customer Service.
Inbound freight of returned Products will be the responsibility of
Biofield, except as noted in Section VII (A) of the Manufacturing
Supply Agreement.
SeaMED agrees to return each Product via UPS ground delivery or
equivalent service to Biofield promptly after completion of service. If
such return Product is under warranty, SeaMED agrees to pay for such
return shipment to Biofield.
IV. WARRANTY SERVICES
SeaMED agrees that within three (3) business days after receipt of a
Product in warranty an assessment shall be completed. SeaMED further
agrees that repair or replacement of defective Products shall be
completed within fourteen (14) business days of receipt. Refer to the
Supply Agreement for additional provisions on the servicing and repair
of Products under the original warranty period.
Products rejected by Biofield, due to failure to conform to the
Certificate of Compliance, which accompanies each new unit, shall be
provided the following additional warranty.
"SeaMED shall be responsible for all freight charges incurred
as a result of any Product rejected for failure to conform,
provided that Biofield provide written notification stating
the reason for rejection in detail within seven (7) business
days of receipt of the new Product at Biofield."
V. OUT OF WARRANTY SERVICES
SeaMED agrees, upon request from Biofield, that within five (5)
business days after its receipt of an out of warranty Product requiring
service or repair, SeaMED will provide Biofield with a good faith
estimate for the cost of repair including parts and labor. Biofield
will provide SeaMED a purchase order number as authorization to proceed
with estimated services or deliver a refusal of purchase order number
as authorization to proceed with estimated services or deliver a
refusal of the estimated services within five (5) business days of
receipt of the estimate. In the event of Biofield's refusal of the
estimated services or failure to authorize services, SeaMED will
promptly return the Product to Biofield and will invoice Biofield for
an evaluation charge of $75.00. Upon authorization to proceed with such
repair SeaMED will perform all service and furnish all materials
(including replacement parts) as required to place the Product in its
original condition, or current specification, as directed by the
customer, normal wear and tear excepted (i.e. abrasions, scratches,
etc.). In the event SeaMED discovers the cost of the repair will exceed
the estimate previously provided Biofield by more than five
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percent (5%), SeaMED will issue a revised estimate to Biofield within
two (2) days of Biofield's authorization to proceed. In the event
SeaMED does not issue a revised quote within two (2) days of Biofield's
authorization to proceed, the original quote will be in effect. If the
revised estimate is not provided as above, the original estimate will
apply. In the event SeaMED issues a revised estimate and Biofield
refuses to authorize the repair, SeaMED will promptly return the
Product to Biofield and invoice Biofield for the actual labor and
material costs already incurred by SeaMED in preparing the estimate and
providing repairs under the original purchase order. The invoiced
amount shall not exceed the original written estimate.
VI. SPARE PARTS
Both parties acknowledge that Biofield reserves the right to directly
perform, or have performed, repair services on Products exclusive of
the warranty periods. SeaMED agrees to provide, upon request, Biofield
requirements of replacement parts necessary for Biofield, or a designee
of Biofield, to perform repair services. Repair services performed on a
Product by anyone other than a SeaMED authorized service facility will
void the warranty as set forth in the Supply Agreement. Biofield shall
report to SeaMED a completed field service report including replacement
of failed parts, for insertion into the device history record, to
include as a minimum, the serial number of the Product, part numbers
and control numbers of component replacements and a description of the
services provided. SeaMED waives responsibility for personal or
property damages caused to or by the Products serviced at Biofield
request by service organizations not authorized by SeaMED.
Spare parts levels will be determined by SeaMED and Biofield to support
the Products in the field based on historical data of parts replaced
from Product failures. A list of these spare parts will be provided to
Biofield.
Subassemblies removed from Products in the field due to failure will be
returned to SeaMED for evaluation and disposition. Warranty parts will
be repaired or replaced at no cost to Biofield. Parts no longer under
warranty will be repaired or replaced. As requested by Biofield, at
Biofield's expense.
Spare parts orders placed in conjunction with Production orders for
delivery to Biofield for Biofield's use will be priced at SeaMED's
present manufacturing rates of 20% material burden and 26% gross
margin. SeaMED will not procure spare parts for Biofield without a
written purchase order authorization from Biofield. Spare parts not
ordered in conjunction with a Production order will be priced in
accordance with SeaMED's Service rates as stated in Section XII herein.
VII. TECHNICAL TRAINING
SeaMED will provide to Biofield, upon request, specific training for
those Products which are produced for Biofield by SeaMED. The level of
training provided by SeaMED shall depend on the level of service to be
provided by Biofield, or a contractor of Biofield as approved by
SeaMED. In no case will SeaMED provide Biofield with a credit for labor
associated with any service provided by Biofield or a contractor of
Biofield.
A. For minor repairs, e.g. power cord, patient cable, fuses,
printers, certain software upgrades, etc., training will be
provided by SeaMED, as requested by Biofield, and approval to
accomplish this may be granted without formal certification.
These repairs will not alter any warranty in effect at the time
of the repair.
B. For repairs requiring the opening of a device, i.e. breaking the
warranty seal, training will be provided as requested by Biofield
and approval to accomplish this may be granted through
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the following certification process.
1. Obtain the following documentation from the service provider
for review: Service policies Service procedures Service
employee-training documents All record keeping procedures
Other Quality procedures that may apply to service Other
documentation and/or records that support the service
function
2. Audit of documentation by SeaMED Service and Quality
departments.
3. Request further documentation (TDB by SeaMED if required)
4. Review information with SeaMED Vice President, Operations.
5. Receive authorization to proceed with the certification
process.
6. Perform an on site audit of the service provider facilities.
Representatives from SeaMED Service and Quality departments'
conduct an on-site audit of the service facilities used by
the outside service source at no cost to Biofield.
7. Training of the provider's service employees.
Engineers and/or technicians being certified to provide
service will attend a period of training at SeaMED, (as
agreed upon by both parties) to become familiar with the
appropriate drawings, procedures and tests for the
Product(s) being serviced. Training will be billed to
Biofield at the current rate for Service Technician
services. Biofield and SeaMED will approve the amount of
time necessary prior to the start of the training.
8. Final certification authorized as appropriate.
9. SeaMED will provide routine audits, at no more than one year
periods and at least on an annual basis, to maintain this
certification.
VIII. BIOFIELD RESPONSIBILITIES
Biofield agrees to the following conditions:
A. Biofield agrees to comply with any current workers "right to
know" laws and regulations, which includes as a minimum specific
biological decontamination of medical equipment that has come in
contact with a patient's open tissues or bodily fluids, prior to
the Product's shipment to SeaMED. Products shipped to SeaMED,
that are noted to require decontamination, shall incur a
decontamination charge of $100.00.
B. Biofield shall provide SeaMED with a detailed summary of the
condition of each Product returned to SeaMED to indicate:
1. Serial number of the Product.
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2. Symptoms of equipment failure. 3. Cosmetic defects for which
Biofield requires service. 4. Point of contact for
additional information. 5. Return shipment information. 6.
Any other various and miscellaneous needs of Biofield.
C. Biofield shall provide to SeaMED detailed summaries of any
service, upgrade or enhancement made by Biofield, or a contractor
of Biofield, to any Product to include:
1. Serial number of Product. 2. Failures found. 3.
Upgrades/Enhancements required. 4. Correct Actions taken. 5.
Location of services provided.
IX. REPRESENTATIONS AND WARRANTIES
SeaMED represents and warrants to Biofield as follows:
A. All service and repair work performed by SeaMED will be performed
in applicable workmanship standards as described in such
standards set forth in SeaMED's proprietary Workmanship Standards
Manual. The Workmanship Standards Manual will be available to
Biofield via SeaMED's web-site for customer access and
information only.
B. SeaMED will comply with all applicable state and federal laws and
regulations governing the service, repair and reprocessing of
medical devices.
C. A.. Products serviced or repaired by SeaMED will, upon completion
of service or repair, conform to the current applicable device
specifications and regulatory requirements.
D. SeaMED will maintain Product Device History Records according to
procedures established for these records. Service information
provided by SeaMED and/or Biofield service facilities shall be
included in the DHR.
E. Copies of all service reports completed by SeaMED including a
list of parts replaced, will be provided to Biofield at the time
the service is completed and the Product is returned.
F. Failure trending of serviced Products will be provided to
Biofield as prescribed by SeaMED Trend Analysis Procedures,
Drawing 910247.
G. Upon Biofield's request and at a mutually agreed to charge,
SeaMED agrees to provide the following additional items to
Biofield:
Validated manufacturing and safety test equipment.
A supply plan for spare parts requirements for Biofield, or a
designee of Biofield to service the Product at the sub-assembly
level, including a definition of the level of repairs that may be
accomplished in the field.
Shipping methods and configurations for repair parts.
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A service manual that provides repair descriptions to the
component level.
Retrofit kits for hardware or software upgrades, including
procedures and testing requirements.
X. INDEMNIFICATION
A. For terms of indemnification refer to the Manufacturing Supply
Agreement.
XI. TERMINATION
A. For conditions of termination refer to the Manufacturing Supply
Agreement.
XII. FEES
A. Labor. Current labor rates are $75.00 per hour. This rate is
subject to change upon 30 days' written notice to Biofield.
B. Parts. Parts are available to customers according to SeaMED
service spare parts policies, currently 20% handling and 40%
Gross Margin. Exceptions may be noted in the current
Manufacturing Supply Agreement.
C. Shipping/Freight. Shipping costs are the responsibility of
Biofield, except as noted in Section III. SeaMED will pay the
return shipping for Products under warranty.
XIII. GENERAL
A. Unless otherwise agreed to in writing, by the parties, any
controversy or claim arising out of, or relating to this
Agreement, or the parties' decision to enter into this Agreement,
or the breach thereof, shall be settled by arbitration through
the American Arbitration Association and in accordance with the
Commercial Arbitration Rules of the American Arbitration
Association. The arbitration proceeding shall be conducted and
presided over by a single neutral arbitrator chosen pursuant to
American Arbitration Association procedures. Decision of the
arbitrator shall be final, finding and not subject to appeal or
review; provided that, either party may request that the
arbitrator review and reconsider his or her decision, in whole or
in part. Judgment upon the award rendered by the arbitrator may
be entered in any court having jurisdiction thereof. The
arbitration shall be held in Seattle, Washington and the
arbitrator(s) shall apply the substantive law of Washington
except that the interpretation and enforcement of this
arbitration provision shall be governed by the federal
Arbitration Act. The arbitrator shall not award either party
punitive damages and the parties shall be deemed to have waived
any right to such damages.
XIV. MISCELLANEOUS
A. For any miscellaneous conditions, or conditions not noted in this
Agreement, refer to the Manufacturing Supply Agreement In the
event any of the terms or conditions of this Agreement conflict
with any of the terms or conditions of the Manufacturing Supply
Agreement, the terms of the Manufacturing Supply Agreement shall
control.
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The following parties have agreed to this Service Agreement.
/s/ TIM DEWITT 5/02/2000
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Tim DeWitt Date
Director of Manufacturing Operations
SeaMED, a Plexus company
/s/ JOHN D. STEPHENS 5/03/00
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John D. Stephens Date
Chief Operating Officer
Biofield Corp.
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