1
Omitted portions of this Exhibit are subject to a Request for
Confidential Treatment under Rule 24b-2.
Exhibit 10.4.45
MANUFACTURING AND SUPPLY AGREEMENT
THIS AGREEMENT entered into this 30th day of March, 2000, between
Neoprobe Corporation, 000 Xxxxx Xxxxx Xxxxx, Xxxxx 000, Xxxxxx, Xxxx 00000
(hereinafter referred to as ("Neoprobe") and Plexus Corp, 00 Xxxxxxxx Xxxx
Xxxxx, X.X. Xxx 000, Xxxxxx, Xxxxxxxxx 00000-0000 (hereinafter referred to as
("Plexus").
WHEREAS, Neoprobe is a biomedical company which, using its proprietary
technology and knowhow, has developed a handheld gamma radiation detection
device used for detection of gamma radiation in radioisotope guided surgery and
intraoperative lymphatic mapping; and
WHEREAS, Plexus is in the business of designing, developing, and
manufacturing electromechanical instruments, medical instruments and electronic
products; and
WHEREAS, Neoprobe desires to have Plexus manufacture and supply the
device to Neoprobe.
NOW, THEREFORE, in consideration of the mutual covenants exchanged
herein the parties agree as follows:
ARTICLE I. DEFINITIONS
1.01 Certificate of Release (or Certificate of Compliance). As used
herein the term "Certificate of Release" is used to mean the document supplied
by Plexus to Neoprobe with each lot or batch of Product stating that all
Product, manufactured by Plexus and comprising that lot, meet or exceed the
"Specifications" for the Product.
1.02 Components. The term "Components" shall mean the individual parts
which are assembled to make a Product, as well as packaging and labeling for
Product.
1.03 Control Unit. The term "Control Unit" shall mean the neo2000,
intraoperative gamma radiation detection device including a microcomputer-based
unit which measures the presence of gamma-emitting isotopes, which unit
translates the gamma pulses received from a Probe (defined in Section 1.12
herein) into understandable displays and sounds.
1.04 Device Master Record. The term "Device Master Record ("DMR") as
used herein shall mean the compilation of records containing the procedures and
specifications for a finished device as described by 21 CFR Section 820.3(j) and
Section 820.18 1.
1.05 Effective Date. The "Effective Date" of this Agreement shall be
the date written herein above.
1.06 FDA and Act. The term "FDA" and the term "Act" as used herein
shall mean the United States Food and Drug Administration or any successor
agency having the administrative authority to regulate the approval for testing
or marketing of human pharmaceutical or biological products and medical devices
in the United States; and the term "Act" as used herein, refers to the Federal
Food, Drug & Cosmetic Act (21 U.S.C. Section 301, et seq.).
1.07 QSR. As used herein the term "QSR" means the current good
manufacturing practice requirements set forth in 21 CFR , Parts 808, 812, and
820 that govern the methods used in, and the facilities, and controls used for,
the design, manufacture, packaging, labeling, installation, and servicing of all
finished devices intended for human use to ensure that the finished device will
be safe and effective and comply with the Act.
1.08 Long Lead Time Component(s). as used herein shall mean all of
those individual parts and materials whose current lead times extend beyond
forty (40) business days. The Long Lead Time Components may,
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
2
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
from time to time, be reviewed by Plexus and Neoprobe, at the request of either
party due to possible changes in market conditions of supply and demand
affecting the procurement by Plexus of the Components and/or Long Lead Time
Components for the assemblies hereunder. Any changes resulting from such review
shall be with the mutual written agreement of Plexus and Neoprobe.
1.09 Monthly Rolling Quantity Forecast of Delivery Requirements. As
used herein shall mean the written documents provided to Plexus by Neoprobe each
month indicating the delivery requirements projected for the next twelve (12)
months.
1.10 NCNR Component(s). As used herein shall mean those parts that are
not cancelable once placed on order with Plexus suppliers, and are not
returnable once delivered to Plexus. The NCNR Component(s) may, from time to
time, be reviewed by Plexus and Neoprobe, at the request of either party due to
possible changes in market conditions of supply and demand affecting the
procurement by Plexus of the Components and/or NCNR Component(s) for the
assemblies hereunder. Any changes resulting from such review shall be with the
mutual written agreement of Plexus and Neoprobe.
1.11 Person. As used herein, the term "Person" shall mean any
individual, corporation, partnership, business trust, business association,
governmental entity, governmental authority or other legal entity.
1.12 Probe. As used herein, the term "Probe" shall mean a handheld
gamma radiation sensing device which connects to the Control Unit.
1.13 Product. The term "Product" as used herein, shall mean the
finished, packaged and labeled Control Unit and or Probe listed on Exhibit 1.13
and "released" in accordance with Section 7.12 herein.
1.14 Quarter. The term "Quarter" as used herein shall mean the
consecutive three (3) month periods beginning January 1, April 1, July 1, and
October 1 of each Year.
1.15 Specifications. As used herein, the term "Specifications" shall
mean the requirements with which the Product must conform as provided by the
device Specifications which are included in the Device Master Record for each
Product.
1.16 Special Component(s) as used herein shall mean those parts that
have special procurement conditions such as limited change parameters or other
special liability conditions that are required by Plexus' suppliers. The Special
Component(s) may, from time to time, be reviewed by Plexus and Neoprobe, at the
request of either party due to possible changes in market conditions of supply
and demand affecting the procurement by Plexus of the Components and/or Special
Component(s) for the assemblies hereunder. Any changes resulting from such
review shall be with the mutual written agreement of Plexus and Neoprobe.
1.17 Year. The term "Year" shall mean the consecutive twelve (12) month
period beginning January 1 of a year and ending December 31 of such year.
ARTICLE II. SUPPLY OF PRODUCT
2.01 Manufacture. Neoprobe hereby appoints Plexus as Neoprobe's
exclusive supplier for all of Neoprobe's requirements for the Products listed on
Exhibit 1.13 and Plexus hereby accepts such appointment.
2.02 Price of Product. The unit price charged by Plexus to Neoprobe for
each unit of Product may be amended from time to time after mutual discussion of
the parties. Unless stated otherwise, prices quoted are F. O. B. Plexus's
manufacturing facility. Unless specifically stated otherwise, all quoted prices
are firm for thirty (30) days from the date of quotation. Quotations are based
on drawings, specifications, and other written information available
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
3
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
to Plexus at the time of quotation. Any additional data supplied at the time of
purchase may necessitate price adjustments.
2.03 Payment of the Purchase Price. Plexus shall xxxx Neoprobe for all
purchases of Product made under this Agreement by invoice sent to Neoprobe at
Neoprobe's address shown on the first page of this Agreement. Neoprobe shall pay
all invoices net thirty (30) days after: (i) receipt of such invoice, and (ii)
receipt of a Certificate of Release for the Product.
2.04 Payment of Taxes. Any manufacturer's tax, retailer's occupation
tax, use tax, sales tax, excise tax, or tax of any nature whatsoever imposed on
or measured by the transaction between Plexus and Neoprobe shall be paid by
Neoprobe in addition to the invoice price for Product. In the event Plexus is
required to pay such tax, Neoprobe shall reimburse Plexus therefore, within ten
(10) days of written demand by Plexus to Neoprobe for such reimbursement. If the
transaction between Plexus and Neoprobe is exempt from all such taxes, Neoprobe
shall provide Plexus with a tax exemption certification or other document
acceptable to all taxing authorities at the time the order is submitted.
2.05 Addition of Other Assemblies to the Agreement. Additional devices
may be added to this Agreement by mutual consent of the parties. Any additional
devices added to this Agreement shall require individual specifications and a
determination of a "per unit" price as described in Section 2.02 hereinabove.
2.06 Failure to Supply All Requirements. In the event Plexus is unable
to supply substantially all of Neoprobe's requirements for Product, for reasons
solely within Plexus' control, Neoprobe may have the right to source Product
from an alternative contract manufacturer, subject to Neoprobe providing Plexus
with six (6) months prior written notice of its desire to source the Product
from an alternative contract manufacturer and Neoprobe has provided Plexus a
reasonable time period to cure any delays in supplying Neoprobe with the
Product. Neoprobe's right to use a third party manufacturer for all or part of
its requirements for Product shall remain in effect until six (6) months after
Plexus notifies Neoprobe that it is once again able to supply substantially one
hundred percent (100%) of Neoprobe's requirements for Product.
2.07 Competitive Pricing. In the event Neoprobe is able to source
Product from a third party manufacturer at a price which is significantly better
(***) than the price charged by Plexus pursuant to Section 2.02, the "exclusive
supplier" status granted to Plexus pursuant to Section 2.01 shall become
nonexclusive; provided however, that Plexus shall have the right to match the
price offered by the third party in which case Plexus shall remain an exclusive
supplier.
2.08 Plexus Becomes Non-Exclusive Supplier. If Plexus' status as
"exclusive supplier" becomes "non- exclusive" in accordance with this Section
2.07, Neoprobe agrees to purchase all finished Product, raw materials, all
Components in Plexus' inventory (including the full markup as defined in the
Plexus Quotation), and other Components for which Plexus has liability or on
order, but which are not in Plexus' inventory, as well as payment for any and
all in-process manufacturing costs and expenses, including, ramp down costs,
cancellation or restocking charges. To help minimize the impact of cancellation
charges, Plexus will attempt to restock components at the supplier, resell the
components, and/or utilize the components on non-Neoprobe assemblies.
ARTICLE III. FORECAST, ORDERS, MATERIALS AND SCHEDULING
3.01 Forecast. Within fifteen (15) days after the Effective Date,
Neoprobe shall deliver to Plexus a forecast of the quantity of Product required
for the initial twelve (12) month period from the Effective Date (the "Initial
Forecast") and shall thereafter update such forecast on a monthly basis and
provide it to Plexus on or before the fifteenth (15th) day of each month so that
the parties have a twelve (12) month rolling forecast of the estimated
requirements for Product. Neoprobe shall promptly notify Plexus, at any time,
Neoprobe anticipates a material
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
4
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
deviation from the forecast. Plexus shall promptly notify Neoprobe at any time
Plexus anticipates a material deviation in its ability to meet the forecast.
3.02 Manufacturing Lead Time. For each Product to be manufactured,
Plexus establishes a manufacturing lead time, which is the number of business
days it will take, on average, to receive and kit all Components, assemble, test
and ship the lot of finished Product. Unless otherwise noted, this manufacturing
lead- time is twenty (20) business days. Plexus schedules all Components for a
particular lot of Product to arrive one manufacturing lead-time prior to the
Neoprobe due date. Plexus then uses this information, together with the Forecast
and Purchase Order information as defined below, to place commitments to its
suppliers for materials.
3.03 Purchase Orders. Neoprobe will issue Neoprobe Purchase Orders
("POs") at least sixty (60) business days prior to the required delivery dates
for Product in accordance with, but not limited to, the Monthly Rolling Quantity
Forecast of Delivery Requirements. Neoprobe POs for delivery with lead times of
less than sixty (60) business days may be mutually agreed to by Plexus and
Neoprobe.
3.04 Monthly Rolling Quantity Forecast of Delivery Requirements.
Neoprobe shall provide to Plexus a Monthly Rolling Quantity Forecast of Delivery
Requirements in accordance with Section 3.01 above. This Monthly Rolling
Quantity Forecast of Delivery Requirements for each assembly shall be used by
Plexus to determine the Components and/or the Long Lead-Time Components, NCNR
Components and/or Special Components that Plexus must obtain and/or procure
and/or inventory, and unless otherwise agreed to, Plexus will negotiate pricing
contracts with its supplier based upon the forecast. Plexus shall procure in
advance of Neoprobe POs for assemblies, pursuant to the Monthly Rolling Quantity
Forecast of Delivery Requirements for each Product, the Components and/or the
Long Lead Time Components, NCNR Components and/or Special Components, as
required for each Product.
3.05 Schedule Changes. Neoprobe may request a change to the delivery
schedule at any time. Schedule changes can have an extraordinary effect on the
amount of inventory at Plexus, the impact for which is not considered in the
original cost of the Product. Frequent schedule changes may result in additional
administrative charges. If Neoprobe determines that the total annual rolling
quantity forecast of delivery requirements for any Product previously specified
in the Monthly Rolling Quantity Forecast of Delivery Requirements will be
delayed and/or reduced in quantity, then Plexus shall notify Neoprobe that
Plexus has procured and is inventorying and/or has on order with its Components
and/or Long Lead Time Components, NCNR Components and/or Special Components
suppliers an excess quantity of Components and/or Long Lead Time Components,
NCNR Components and/or Special Components that Plexus shall be unable to use for
any other currently forecasted Product requirement specified in the Monthly
Rolling Quantity Forecast of Delivery Requirements. Rescheduling of delivery
requirements less than thirty (30) days prior to the delivery date may only be
done with mutual agreement between Plexus and Neoprobe. Any schedule change may
result in a "Schedule Change Condition" as described in Section 3.06 and Section
3.07 below with corresponding liability to Neoprobe.
3.06 Schedule Decreases. For schedule decreases issued within the
manufacturing lead-time of the scheduled delivery date, Neoprobe will either:
a) Accept shipment of the completed assemblies within the
calendar month originally scheduled: or
b) Pay full price and accept title and risk of los for completed
assemblies and any work in process materials and labor. Plexus
will warehouse completed assemblies for a reasonable period of
time.
For schedule decreases issued outside the manufacturing lead-time of the
scheduled delivery date, the Neoprobe will:
a) Pay for and accept title and risk of loss for the value of the
components (including the full component markup as defined in
the Plexus quotation) which Plexus is unable to return or
reschedule to meet the new schedule requirements; and
b) Pay Plexus for any additional cost from suppliers resulting
from the rescheduling.
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
5
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
3.07 Schedule Increases. For schedule increases, Plexus will make its
best effort to obtain the Components necessary to meet Neoprobe requirements.
However, Plexus may be unsuccessful in obtaining all of the Components required
to meet the Neoprobe's increased requirements. In that situation, Plexus
reserves the right to Neoprobe payment of the value of all inventory in house as
of the delivery date that is a result of the increased requirement.
3.08 Engineering Change. The term "Engineering Change(s)" (hereinafter
called "EC" or "EC's") shall mean those mechanical, software, or electrical
design and/or specification and requirement changes which, if made to the
Product to be delivered hereunder, would affect the schedule, performance,
reliability, quality, availability, serviceability, appearance, dimensions,
tolerance, safety or purchase price of such Product or which would require
additional approval testing. Plexus may determine that Engineering Changes will
affect its ability to maintain the delivery schedule of Product , due to the
lead time of newly specified parts and/or the impact of substantial rework or
modification. Under these circumstances, Plexus reserves the right to define a
new schedule for delivery and treat this as a Schedule Change Condition, with
the Neoprobe liability as defined under Section 3.06 or Section 3.07. Upon
receipt of an EC, Plexus shall review Neoprobe's proposed EC and shall give to
Neoprobe a written evaluation of the EC, stating Plexus' cost to implement the
EC (including the cost to modify any tooling), the excess quantity of Components
and/or Long Lead Time Components, NCNR Components and/or Special Components
Plexus has inventoried and/or has on order with its Components and/or Long Lead
Time Components, NCNR Components and/or Special Components suppliers that are
unusable for any other assembly requirement and excess due to the EC, and
associated costs and expenses such Components and/or Long Lead Time Components,
NCNR Components and/or Special Components that Neoprobe shall be liable for and
the cost savings, if any, resulting from the EC, and the expected effect on the
schedule, availability and/or purchase price of such assemblies, or which may
require additional approval tests by Neoprobe.
3.09 Cancellation. Neoprobe may cancel requirements defined in orders
and/or forecasts at any time before the scheduled delivery date. Any Product
requirements canceled within the manufacturing lead-time of the scheduled
delivery date will be invoiced at the full agreed to price for the completed
Product. For Product requirements canceled outside the manufacturing lead time
of the scheduled delivery date, Neoprobe's liability to Plexus will be the value
of the Components in Plexus' inventory (including the full markup as defined in
the Plexus Quotation), and other Components for which Plexus has liability or on
order, but which are not in Plexus' inventory, as well as payment for any and
all in-process manufacturing costs and expenses, including, ramp down costs,
cancellation or restocking charges. To help minimize the impact of cancellation
charges, Plexus will attempt to restock components at the supplier, resell the
components, and/or utilize the components on non-Neoprobe assemblies.
3.10 Changes to Specifications. Neoprobe shall have the right to change
the Specifications for a Product to make reasonable and lawful modifications to
Product Specifications; provided, however, that Plexus shall have a reasonable
period of time to implement such Product Specification changes, and shall be
entitled to full reimbursement by Neoprobe for any costs incurred by Plexus in
implementing such changes, including cost of materials which can not be utilized
as a result such change. Neoprobe shall absorb all reasonable adjustments to
pricing for a Product which may be required as a result of the Specification
change. Neoprobe is responsible for verification and/or validation of any
changes to the Specifications.
3.11 Delivery of Product. Unless otherwise mutually agreed to by the
parties, Plexus shall ship Product to a distribution facility designated by
Neoprobe.
ARTICLE IV. COMPONENTS
4.01 Responsibility for Components. Unless otherwise agreed to by the
parties, Plexus shall be responsible for ordering, purchasing and maintaining
sufficient Components to support manufacture of Product in accordance with the
forecast described in Section 3.01 herein.
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
6
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
4.02 Neoprobe Supplied Parts. Neoprobe may provide certain components
required to build Neoprobe's Product in which case, Neoprobe's inability to
provide parts in a timely manner may effect Plexus's ability to meet its
delivery schedule and may cause Plexus to incur extraordinary expenses to hold
Plexus purchased material and/or labor in process. Under these circumstances,
Plexus reserves the right to define a new schedule for delivery based upon
component availability information from Neoprobe and treat this as a Schedule
Change Condition, with Neoprobe liability as defined under Section 3.06 or
Section 3.07 above.
4.03 Minimum Component Purchases. Plexus may have to place orders for
quantities of Components in excess of that required to support Neoprobe
requirements. This may be as a result of minimum order size requirements or
standard package sizes from the supplier. Neoprobe agrees to have the cost of
the excess Components amortized over a maximum of six (6) month's requirements,
or will place a purchase order separately for the excess Components.
ARTICLE V. TOOLING
5.01 Ownership of Tooling. Plexus shall procure and/or produce upon
mutual pre-approvals, all tools, dies, jigs, and fixtures required to
manufacture Product. Plexus shall invoice Neoprobe for all labor and materials
required to procure or produce all such tooling, jigs, fixtures, and the like,
and upon payment Neoprobe shall obtain unrestricted ownership thereof and to the
detailed assembly drawings for such tooling. Neoprobe shall have the right to
access such drawings at all times during the term of this Agreement. All
replacement tools required shall also be owned by Neoprobe upon payment by
Neoprobe of the cost thereof. Termination of this Agreement shall result in the
surrender by Plexus of all tools, drawings for tools, replacement tools,
fixtures and jigs paid for and owned by Neoprobe. The tooling described herein
shall be utilized by Plexus only for the production and/or testing of the
Product. All tooling quoted herein is quoted at the cost to Plexus from its
suppliers. A procurement charge of *** will be added to all tooling with a cost
of less than ***, and a *** procurement charge added to all tooling with a cost
of *** or greater.
5.02 Tooling Maintenance. At all times under this Agreement during
which Plexus has possession of Neoprobe tooling, Plexus shall have the
responsibility of performing normal, expected maintenance and repairs. The cost
of modifying or replacing or rebuilding Neoprobe owned tooling worn through
usage or in need of major repair for reasons other than lack of periodic
maintenance shall be borne by Neoprobe. Plexus shall be responsible for such
costs if such costs are incurred due to a failure to perform proper maintenance
or due to damage due to misuse or negligence of Plexus. Payment for the cost of
any other required tooling changes shall be negotiated by the parties prior to
any change. All modifications and major repairs to tooling must be approved in
advance by Neoprobe. Plexus will obtain a warranty on all tooling purchased by
Plexus for Neoprobe that warrants the tooling against defect during its normal
useful life and that obligates the supplier to replace without cost any
defective tooling. Neoprobe shall have the right to inspect all tooling during
normal business hours. Plexus agrees that it will obtain agreement from any
third parties that will be given possession of Neoprobe owned tooling that such
third parties will permit Neoprobe to inspect tooling during normal business
hours.
5.03 Tooling Removal. Upon expiration or termination of this Agreement,
Neoprobe shall have the night to take possession of and remove from the Plexus
facility, all tooling owned by Neoprobe. The cost of removing and transferring
such tooling shall be borne by Neoprobe. In addition to jigs, fixtures, and
tooling, Neoprobe may take possession of a detailed assembly drawing for such
tooling subject to the conditions stated. Plexus assumes no patent
responsibility and gives no express warranty whatever on tooling and equipment
removed and, other than warranty of title, such tooling is removed "as is."
ARTICLE VI. PLEXUS REPRESENTATIONS, & WARRANTIES
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
7
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
6.01 QSR Compliance. Plexus represents and warrants that, during the
term of this Agreement it shall maintain its manufacturing facility in
accordance with applicable local, state and Federal rules and regulations and
that all Product manufactured pursuant to this Agreement shall be manufactured
in accordance with all applicable local, state, and Federal rules and
regulations and in accordance with applicable QSR requirements.
6.02 Product Within Specifications. Plexus represents and warrants that
all Product shall be manufactured in strict accordance with the Specifications
for such Product and shall be packaged and shipped in accordance with Neoprobe's
approved packaging and shipping specifications.
6.03 Workmanship/Product Warranty. Subject to the limitations set forth
in Section 6.04 below, PLEXUS EXPRESSLY WARRANTS THE WORK AS SET FORTH HEREIN.
PLEXUS MAKES NO OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED (INCLUDING WITHOUT
LIMITATION WARRANTIES AS TO MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSES).
IN ADDITION, THE FOLLOWING SHALL CONSTITUTE THE EXCLUSIVE REMEDIES FOR NEOPROBE
FOR ANY BREACH BY PLEXUS OF ITS WARRANTIES HEREUNDER. Plexus warrants the
assemblies against all defects in workmanship where the assemblies do not
conform to the agreed upon manufacturing specifications, for a period of one (1)
year from date of shipment, provided agreed upon testing is conducted by Plexus
prior to shipment, except as set forth below. If the material furnished contains
a manufacturer's warranty, Plexus extends, to the extent possible, such
manufacturer's warranty to Neoprobe. Plexus shall repair or replace, at Plexus's
option and free of charge, any portion of the assemblies which is returned to
Plexus's factory securely packaged, insured and with freight pre-paid within the
warranty period, and which upon examination Plexus determines in its sole
discretion to be defective in workmanship. Plexus will return the repaired or
replaced assemblies to Neoprobe with freight pre-paid.
6.04 Limitations on Warranty. The warranty set forth in Section 6.03
herein does not apply to:
a) Any design deficiencies. Plexus expressly disclaims any
warranty responsibility for design deficiency, and for
infringement for the like.
b) Any modifications and/or alterations made to th Product, or
any portion thereof, without the express written authorization
of Plexus obtained in advance. If this is the case, all
warranties made herein are invalid and Neoprobe shall have no
further remedies hereunder against Plexus.
c) Any defect, loss or damage resulting from theft loss, fire,
misuse, abuse, negligence, vandalism, acts of God, accident,
casualty, power failures or surges, alteration, modification
or failure to follow installation, operation or maintenance
instructions, or any other cause beyond Plexus's reasonable
control.
d) Components incorporated into the Product.
IN NO EVENT, REGARDLESS OF CAUSE, SHALL PLEXUS BE LIABLE FOR INCIDENTAL,
INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES OR LOSSES OF ANY KIND, WHETHER IN
CONTRACT OR IN TORT, ARISING FROM ITS PERFORMANCE UNDER THIS AGREEMENT.
6.05 Training of Plexus Personnel. Plexus represents and warrants that
all workmanship performed pursuant to this Agreement shall be performed by
properly trained and authorized Plexus personnel in accordance with Plexus'
quality system and standards.
6.06 Selection of Suppliers. Plexus agrees it shall use reasonable
commercial efforts in selecting third party Component suppliers
ARTICLE VII. REGULATORY
7.01 Compliance with Regulations and Standards. The parties shall
cooperate in providing, as required, information to governmental agencies in
order to obtain and maintain necessary approvals to manufacture and
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
8
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
market Product. Neoprobe shall be responsible for initiating interaction with
regulatory authorities such as the FDA including MDR filing
7.02 Neoprobe Responsibilities. Neoprobe shall be responsible for
ensuring that the Product covered by this Agreement complies with all applicable
laws and regulations, including the Act and implementing regulations. Neoprobe
responsibilities under this Section 7.02, include but are not limited to the
following:
a) Ensuring that governmentally-required marketing
authorizations, including any necessary FDA approvals or
clearances, have been obtained;
b) Responsibility for the content of any label or labeling;
c) Preparation and submission of any required reports to
governmental entities, including but not limited to medical
device reports (MDR's);.
d) Determining whether any recall or other corrective action is
required or appropriate, and developing, implementing and
financing any voluntary or mandatory recall or corrective
action.
e) Reviewing and approving the quality system prior to production
of the Product.
7.03 Test Equipment. Neoprobe will provide Plexus with sufficient
information to calibrate, operate, test and maintain any Neoprobe supplied
equipment.
7.04 Software Validation. Neoprobe shall be responsible for the
software validation of any embedded product software and the validation of all
Neoprobe-supplied test equipment or test software, Neoprobe supplied production
equipment or software, and Neoprobe supplied firmware. Plexus is responsible for
the validation of any Plexus software used in production or as part of the
Quality System. The responsibilities described in this Section 7.04 also apply
to any revisions of any software. Upon the request by Plexus, Neoprobe will
provide Plexus with written certification that the validations in required by
this Section 7.04 have been performed.
7.05 Corrective Actions. Plexus shall be responsible for conducting and
documenting corrective and preventive actions based upon the analysis of the
quality data available to Plexus. Quality data or information known to Neoprobe,
but not provided to Plexus, shall not be included in the analysis of quality
data, and Neoprobe shall be responsible for the analysis of data not provided to
Plexus.
7.06 Component Traceability. Neoprobe shall be responsible for defining
any "critical" components of the Product requiring component level traceability.
Neoprobe must also select the appropriate component level or Product level
traceability grade, in order to meet any applicable FDA requirements or
regulations. Plexus is responsible for implementing the defined
manufacturing-level traceability requirements and for ensuring that the
appropriate manufacturing-level traceability records and associated records are
retained for the duration of the Agreement. Unless otherwise specified in the
Agreement, Plexus is not responsible for ensuring traceability of the Product
covered by this Agreement after distribution to the end user(s).
7.07 Release of Nonconforming Product. Neoprobe may authorize in
writing the release of nonconforming components or Product covered by this
Agreement. Neoprobe must assess whether the use of the nonconforming Product
will affect any regulatory submittals or requirements, and accept responsibility
therefore.
7.08 Product Complaints. Neoprobe shall be responsible for all
complaint handling, including but not limited to maintenance of complaint files,
investigation of complaints, resolution of complaints, trending or otherwise
analyzing complaints, and maintaining complaint-related records. Plexus shall
cooperate with Neoprobe in Neoprobe's investigation of Product complaints.
Neoprobe will promptly provide to Plexus copies of all
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
9
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
complaints received by Neoprobe that refer or relate to Product manufactured by
Plexus and all adverse event reports to a governmental entity that refer or
relate to Product manufactured by Plexus. Any complaints received by Plexus
shall be forwarded to Neoprobe within five (5) working days. Plexus agrees to
provide failure analysis and/or statistical defect analysis of Product covered
by this Agreement, provided Neoprobe returns the product to Plexus' s facility.
Neoprobe shall be responsible for all costs, including but not limited to
freight and insurance, both to Plexus's facility and the return to Neoprobe.
Plexus shall supply Neoprobe with copies of all such failure analyses for
Neoprobe's files. If decontamination is required, Neoprobe and Plexus must
mutually develop the required documentation procedures to be used on the
returned Product.
7.09 Maintenance of Records. Plexus shall be responsible for
maintaining the DHR and DMR for each lot or batch of Product, as well as the
retention of such records in accordance with Neoprobe's record retention SOP
that has been provided to Plexus by Neoprobe. Unless otherwise agreed to by the
parties, records shall be returned to Neoprobe, at Neoprobe's cost, at the end
of the applicable retention period
7.10 Plexus Cooperation In Regulatory Matters. Plexus agrees to
cooperate fully with Neoprobe in connection with Neoprobe's handling of
Neoprobe's obligatory regulatory matters such as adverse event reporting,
complaint disposition, Product tracking, Product recalls and safety alerts.
Plexus agrees to provide routine cooperation at no cost to Neoprobe. Neoprobe
shall be responsible for costs incurred by Plexus as a result of its cooperation
with Neoprobe. In the event of any recall of any Product, caused by Plexus' sole
negligence, and within product warranty as defined, (i) Plexus shall repair or
replace, at Plexus's sole discretion, the recalled Product without charge to
Neoprobe, and (ii) Plexus shall reimburse Neoprobe for its reasonable
out-of-pocket expenses incurred in connection with such recall up to a maximum
of *** in the aggregate (not per occurrence).
7.11 Facility Inspection. Neoprobe shall have the right, during
reasonable business hours, and with reasonable prior notice, to audit all phases
of Product manufacturing activities at Plexus in order to verify compliance with
the Product Specifications and applicable regulatory requirements as they apply
to Neoprobe's product. The cost of conducting such audits shall be borne by
Neoprobe. Plexus agrees to give Neoprobe access during normal working hours to
such records as are reasonably necessary to enable Neoprobe to conduct its
audit, including quality control records, test records, DHRs, DMR, and to permit
Neoprobe to review and copy such records, if applicable. Neoprobe's right of
access to inspect and copy Confidential information of Plexus shall be
restricted to those matters necessary to verify the compliance of Plexus with
the Specifications and regulatory requirements.
7.12 Product Release. Unless otherwise agree to by the parties in
writing, Product shall be "released" according to the following procedure:
a) Plexus shall send by facsimile, a copy of the DHR for a
Control Unit to the "Designated Person" in Neoprobe's
Regulatory Affairs, Quality Assurance group;
b) The Designated Person shall review the DHR and shall sign and
date it, indicate approval or nonapproval and fax the DHR to
Plexus;
c) Upon receipt of an approved DHR, Plexus shall b authorized to
"release" Product for sale; and
d) Plexus shall ship released Product to Neoprobe' designated
Product distribution center.
Notwithstanding the above, if Neoprobe receives an approved DHR, payment of the
product shall not be withheld by Neoprobe unduly and Neoprobe shall pay all
invoices net thirty (30) days after receipt of such invoice and receipt of
Plexus' Certificate of Compliance.
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
10
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
7.13 Responsibility for Meeting European Requirements. The parties
shall be responsible for meeting European regulatory requirements as follows:
a) Neoprobe is responsible for making the appropriate
arrangements with its Notified Body before Plexus will apply
the CE xxxx to the Product.
b) Neoprobe must inform the Notified Body that Plexus will apply
the CE xxxx, when applicable.
c) Plexus shall be responsible for notifying Neoprobe of any
reports of "incidents" or "near incidents", which allege death
or serious injury to a patient.
d) Neoprobe is responsible for any subsequent reporting to the
Competent Authorities of the EEA (European Economic Area).
e) Neoprobe is responsible for conducting any advisory notices or
recall that are required on medical product manufactured by
Plexus and sold by Neoprobe in the EU area.
f) Plexus is responsible for retaining the appropriate medical
records for the lifetime of the medical device. Since Plexus
does not have access to date describing the lifetime of the
medical device, Plexus will retain the appropriate medical
records as required, or until the Agreement with Neoprobe
ends.
7.14 ISO 9000 Certification. Plexus Electronic Assembly Corporation
(manufacturing) is Certified ISO 9002; Plexus Technology Group Incorporated
(product design/development) is Certified ISO 9001. Plexus agrees that it shall
maintain its ISO certification at all times during the term of this Agreement.
Plexus agrees to immediately notify Neoprobe of any change in its ISO
Certification status. Plexus agrees to provide copies of its ISO certifications
to Neoprobe as they are renewed.
ARTICLE VIII. TERM & TERMINATION
8.01 Term. Unless earlier terminated by the parties pursuant to this
Article VIII, the term of this Agreement shall be from the Effective Date until
December 31, 2003; provided however, that the term of this Agreement may be
extended for additional one (1) year periods by mutual written agreement of the
parties given no later than six (6) months prior to the termination date.
8.02 Early Termination by Neoprobe. Beginning January 1, 2001, Neoprobe
may terminate this Agreement for any reason upon six (6) months prior written
notice to Plexus. During the notice period, Plexus shall use reasonable
commercial efforts to control costs during the notice period and to minimize any
cost liability accruing to Neoprobe pursuant to Section 8.06.
8.03 Termination for Material Breach. Either party may terminate this
Agreement in the event of a material breach by the other, provided that the
party asserting such breach first serves written notice of the alleged breach on
the offending party and such alleged breach is not cured within thirty (30) days
of said notice.
8.04 Termination for Insolvency. In the event that either party shall
become insolvent or shall suspend its business, or shall file a voluntary
petition or any answer admitting the jurisdiction of the court and the material
allegations of, or shall consent to, an involuntary petition pursuant to or
purporting to be pursuant to any reorganization or insolvency law of any
jurisdiction, or shall make an assignment for the benefit of creditors, or shall
apply for or consent to the appointment of a receiver or trustee of all or a
substantial part of its property (such party, upon the occurrence of any such
event, a "Bankrupt Party"), then to the extent permitted by law the other party
hereto may thereafter immediately terminate this Agreement by giving notice of
termination to the Bankrupt Party.
8.05 Termination for Failure to Supply. Notwithstanding the provisions
of Section 13.01, in the event Plexus is unable to supply Product to Neoprobe
for a *** period due to a delay caused by Plexus, Neoprobe shall have the right
to terminate this Agreement upon *** prior to notice to Plexus. If Plexus is
able to resume supply of substantially all of Neoprobe's requirements during
such *** period, this Agreement shall remain in full force and effect.
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
11
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
8.06 Early Termination Liability. In the event of an early termination
of this Agreement by Neoprobe pursuant to Section 8.02 or by Plexus pursuant to
Section 8.03 or Section 8.04, Neoprobe shall be responsible for payment for all
Product scheduled for delivery, for the cost of all materials in inventory or on
order as reflected by open Purchase Orders, for component price adjustments
caused by Neoprobe purchase order cancellations, and for noncancelable and non
returnable materials. Plexus shall use all reasonable efforts to minimize any
and all purchase order cancellation charges, billbacks, and/or restocking
charges.
8.07 Rights or Obligations Upon Termination. Termination of this
Agreement, for whatever reason, shall not affect any rights or obligations which
may have accrued to either party prior to the effective date of termination.
8.08 Confidentiality Upon Termination. The obligations of
confidentiality in Article X and of Indemnification as provided in Article XI
shall survive the expiration or termination of this Agreement.
ARTICLE IX. INTELLECTUAL PROPERTY
9.01 Right to Use Plexus' Proprietary Information. Plexus hereby grants
to Neoprobe and Neoprobe hereby accepts an irrevocable royalty-free nonexclusive
right to use all Confidential Information of Plexus to the extent the use of
such Confidential Information is needed to assemble Product in accordance with
the Specifications. In the event of termination of this Agreement by Neoprobe
pursuant to Section 8.02 or by either party pursuant to Section 8.04, Neoprobe
shall, with prior written approval of Plexus, such consent not to be
unreasonably withheld have the right to grant a sublicense to a third party to
use such Confidential Information to the extent necessary to enable a third
party to manufacture Product on behalf of Neoprobe
9.02 Intellectual Property Rights. All patents, copyrights, trademarks,
or other rights pertaining to inventions, developments, or improvements made in
the course of the work performed by Plexus hereunder are the property of
Neoprobe. Plexus will, upon written direction from Neoprobe, execute any and all
papers and documents prepared or submitted by Neoprobe as may be reasonably
required to transfer or secure to Neoprobe full title and authority over such
rights. Plexus will be compensated by Neoprobe for time and expense as incurred
in this obligation at the then current billing rates for those of its employees
necessary for these purposes.
9.03 Rights to Neoprobe's Intellectual Property. No rights are granted
hereunder to Plexus under any patents, trademarks or copyrights owned or
controlled by Neoprobe except as are incidental only to the manufacture of
Product by Plexus for Neoprobe.
9.04 Indemnity for Infringement. Neoprobe shall assume all
responsibility for determining whether the Product to be manufactured by Plexus
infringes on any patent, copyright or trademark held by a third party, and
Neoprobe shall indemnify and hold harmless Plexus from any liability, including
legal costs and expenses, damages and attorney fees arising from any claim
demand or suit, made by a third party based on allegations or claims that the
Product or any design, patent, copyright, or trademark used in connection with
the Product constitutes an infringement of any patent, trademark or copyright of
the United States or any foreign county held by such third party. In the event
any such claim or suit is asserted or instituted against Plexus, Plexus shall
promptly notify Neoprobe of the assertion of any such allegation or claim.
Neoprobe shall thereupon assume responsibility for and conduct the defense of
each assertion or suit at its expense, and reasonable information and assistance
for the defense of same shall be provided by Plexus for which Plexus will be
compensated for time and expenses at its current billing rate. Plexus shall have
the right, at its expense, to be represented in the defense of any such
assertion or suit by counsel of its own selection.
ARTICLE X. CONFIDENTIALITY
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
12
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
10.01 Confidential Information. Each party ("Receiving Party") shall
maintain in confidence all information heretofore or hereafter disclosed by the
other ("Disclosing Party") which such party knows or has reason to know are
trade secret and other proprietary information owned by or licensed to the
other, including, but not limited to, information relating to the Product and
licenses, patents, patent applications, technology or processes and business
plans of the other party, including, without limitation, information designated
as confidential in writing from one party to the other (all of the foregoing
hereinafter referred to as "Confidential Information"), and shall not use such
Confidential Information except as permitted by this Agreement or disclose the
same to anyone other than those of its officers, directors or employees as are
necessary in connection with such party's activities as contemplated by this
Agreement. Each party shall use its best efforts to ensure that its officers,
directors and employees do not disclose or make any unauthorized use of such
Confidential Information. Each party shall notify the other promptly upon
discovery of any unauthorized use or disclosure of the other's Confidential
Information.
10.02 Limitations on Confidentiality. The obligation of confidentiality
contained in this Article X shall not apply to the extent that: i) the Receiving
Party is required to disclose information by applicable law, regulation or order
of a governmental agency or a court of competent jurisdiction; ii) the Receiving
Party can demonstrate that the disclosed information was at the time of
disclosure already in the public domain other than as a result of actions or
failure to act of the Receiving Party, its officers, directors or employees, in
violation hereof, iii) the disclosed information was rightfully known by the
Receiving Party (as shown by its written records) prior to the date of
disclosure to the Receiving Party in connection with this Agreement; or iv) the
disclosed information was received by the Receiving Party on an unrestricted
basis from a source which is not under a duty of confidentiality to the other
party.
10.03 Disclosure Required by Law. In the event that the Receiving Party
shall be required to make disclosure pursuant to the provisions of Section 10.02
(i) as a result of the issuance of a court order or other government process,
the Receiving Party shall promptly, but in no event more than forty-eight (48)
hours after learning of such court order or other government process, notify, by
personal delivery or facsimile, all pursuant to Section 12.04 hereof, the
Disclosing Party and, at the Disclosing Party's expense, the Receiving Party
shall: i) take all reasonably necessary steps requested by the Disclosing Party
to defend against the enforcement of such court order or other government
process; and ii) permit the Disclosing Party to intervene and participate with
counsel of its choice in any proceeding relating to the enforcement thereof.
10.04 Equitable Remedies for Breach of Confidentiality. The parties
acknowledge that their failure to comply with the provisions of Section 10.0 1
of this Article X may cause irreparable harm and damage to the name and
reputation of the other party for which no adequate remedy may be available at
law. Accordingly, the parties agree that upon a breach by a party of such
provisions, the nonbreaching party may, at its option, enforce the obligations
of the breaching party under those provisions by seeking equitable remedies in a
court of competent jurisdiction.
ARTICLE XI. INDEMNIFICATION
11.01 Plexus Indemnity. Plexus agrees to indemnify, protect and defend
Neoprobe and hold Neoprobe harmless from and against any claims, damages,
liability, harm, loss, costs, penalties, lawsuits, threats of lawsuit, or other
governmental action, including reasonable attorneys' fees, brought or claimed by
any third party which: (i) arise solely as the result of Plexus' solely
negligent or intentional breach of this Agreement or of warranty or
representation made to Neoprobe under this Agreement; or, (ii) which result from
any claim made against Neoprobe as a result of Plexus' solely negligent or
intentional supply of defective Product to Neoprobe and as a result of Plexus'
manufacturing processes only; provided however, that Plexus will not be liable
for errors, or expenses which may be incurred in its performance of the work
under this Agreement which results from the engineering and/or design of the
Product, or from Plexus' reliance upon information, technological records,
sketches, drawings, or prototypes furnished by Neoprobe or Neoprobe's design
engineering firm.
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
13
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
11.02 Neoprobe Indemnity. Neoprobe agrees to indemnify, protect, and
defend Plexus and hold Plexus harmless from and against any claims, damages,
liabilities, harm, loss, costs, penalties, lawsuits, threats of lawsuit, recalls
or other governmental action, including reasonable attorneys' fees, brought or
claimed by any third party, which: (i) arise out of Neoprobe's negligent or
intentional breach of this Agreement or of any warranty or representation to
Plexus under this Agreement; or, (ii) result from the negligent acts or willful
malfeasance on the part of Neoprobe or its employees or agents, in connection
with Neoprobe's sale, marketing or distribution of Product or other activities
or actions in connection with the Product.
11.03 Notice of Defense of Actions. Each party shall give the other
prompt notice of any potential liability, and promptly after receipt by a party
claiming indemnification under this Article XI of notice of the commencement of
any action, such indemnified party shall notify the indemnifying party of the
commencement of the action and generally summarize such action. The indemnifying
party shall have the right to participate in and to assume the defense of such
action with counsel of its choosing. An indemnified party shall not have the
right to direct the defense in such an action of an indemnified party if counsel
to such indemnified party has reasonably concluded that there may be defenses
available to it that are different from or additional to those available to the
indemnifying party; provided, however, that in such event, the indemnifying
party shall bear the fees and expenses of separate counsel reasonably
satisfactory to the indemnifying party. The failure to notify an indemnifying
party promptly of the commencement of any such action, if prejudicial to the
ability to defend such action, shall relieve such indemnifying party of any
liability to the indemnified party under this Article XI. No settlement of any
claim or action may be made without the consent of the indemnifying party, which
consent shall not be unreasonably withheld or delayed.
ARTICLE XII. GENERAL WARRANTY
12.01 General Warranty. Each Party hereby represents and warrants that:
a) it has full power and authority to execute and deliver this
Agreement and to consummate the transactions contemplated
herein;
b) this Agreement and the provisions hereof constitute the valid
and legally binding obligations of each party and do not
require the consent, approval or authorization of any Person,
public or governmental authority or other entity;
c) he execution and delivery of this Agreement by each party, and
the performance of a Party's obligations hereunder, are not in
violation of breach of, and will not conflict with or
constitute a default under, the Articles of Incorporation or
Bylaws of either Party, or any material agreement, contract,
commitment or obligation to which either Neoprobe or Plexus is
a party or by which either of it is bound; and
d) will not conflict with or violate any applicable law, rule,
regulation, judgment, order or decree of any governmental.
agency or court having jurisdiction over either party or its
assets or properties.
ARTICLE XIII. MISCELLANEOUS
13.01 Force Majeure. Neither of the parties to this Agreement shall be
liable to the other party for any loss, injury, delay, damage or other casualty
suffered or incurred by such other party due to strikes, lockouts, accidents,
fire, embargoes, explosions, floods, war, governmental action or any other cause
similar thereto which is beyond the reasonable control of such other party and
any failure or delay by a party in the performance of any of its obligations
under this Agreement shall not be considered as a breach of this Agreement due
to, but only so long as there exists, one or more of the foregoing causes;
provided, however, that if Plexus cannot complete an order within ninety (90)
days due to any such cause, Neoprobe may cancel the order without liability to
Plexus, except for product assemblies, parts or components already in inventory,
but not yet shipped, non-cancelable and non- returnable components and work
already in progress.
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
14
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
13.02 Relationship. This Agreement shall not be construed to create
between the parties hereto or their respective successors or permitted assignees
the relationship of principal and agent, joint-venturers, copartners or any
other similar relationship, the existence of which is hereby expressly denied by
each party. Neither party shall be liable to any third party in any way for
engagement, obligation, contract, representation or transaction or for any
negligent act or omission to act of the other except as expressly provided.
13.03 Governing Law. The parties hereby agree that this Agreement shall
be governed by and will be construed in accordance with the laws of the State of
Wisconsin, irrespective of the conflicts of laws provisions thereof. The parties
hereby irrevocably submit to the jurisdiction of the courts of the State of
Wisconsin in any action or proceeding arising out of or relating to this
Agreement, and the parties hereby irrevocably agree that all claims in respect
of such action or proceeding may be determined by such courts. The parties
hereby waive, to the fullest extent possible, the defense of an inconvenient
forum to the maintenance of such action or proceeding, and the parties agree
that a final judgement in any action or proceeding shall be conclusive and may
be enforced in other jurisdictions by suit on the judgement or in any other
matter provided by law.
13.04 Arbitration. 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, binding, 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 Neenah, Wisconsin and the
arbitrator shall apply the substantive law of Wisconsin 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.
13.05 Notice. All notices, proposals, submissions, offers, approvals,
agreements, elections, consents, acceptances, waivers, reports, plans, requests,
instructions and other communications required or permitted to be made or given
hereunder (all of the foregoing hereinafter collectively referred to as
"Communications") shall be in writing, and shall be deemed to have been duly
made or given when: i) delivered personally with receipt acknowledged; or ii)
sent by registered or certified mail or equivalent, return receipt requested; or
iii) sent by facsimile or telex; or iv) sent by recognized overnight courier for
delivery within twenty-four (24) hours, in each case addressed or sent to the
parties at the following addresses and facsimile numbers or to such other or
additional address or facsimile as any party shall hereafter specify by
Communication to the other party:
To Neoprobe: Xxxxx X. Xxxx
President & CEO
Neoprobe Corporation
000 Xxxxx Xxxxx Xxxxx, Xxxxx 000
Xxxxxx, Xxxx 00000
Fax No. (000) 0000000
With a Copy to: Xxxx X. Xxxxx
Vice President, Instrument Development
Neoprobe Corporation
000 Xxxxx Xxxxx Xxxxx, Xxxxx 000
Xxxxxx, Xxxx 00000
Fax No. (000) 0000000
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
15
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
To Plexus: Strategic Customer Manager
Plexus Corp.
00 Xxxxxxxx Xxxx Xxxxx
P.O. Box 156
Neenah, Wisconsin 549570156
Fax No.: (000) 0000000
With a Copy to: Xxxxxx X. Xxxxxxx
Vice President
Law and Administration
Plexus Corp.
00 Xxxxxxxx Xxxx Xxxxx
P. O. Xxx 000
Xxxxxx, XX 00000-0000
Fax No. (000)000-0000
Notice of change of address shall be deemed given when actually received, all
other Communications shall be deemed to have been given, received and dated on
the earlier of: when actually received, or on the date when delivered
personally; ii) one (1) day after being sent by facsimile, cable, telex (each
promptly confirmed by a writing as aforesaid) or overnight courier; or iii) four
(4) business days after mailing.
13.06 Legal Construction. In case any one or more of the provisions
contained in this Agreement shall be invalid or unenforceable in any respect,
the validity and enforceability of the remaining provisions contained herein
shall not in any way be affected or impaired thereby the parties will attempt to
agree upon a valid and enforceable provision which shall be a reasonable
substitute for such invalid and unenforceable provision in light of the tenor of
this Agreement, and, upon so agreeing, shall incorporate such substitute
provision in this Agreement.
13.07 Entire Agreement, Modifications, Consents, Waivers. This
Agreement together with the Exhibits hereto contains the entire agreement of the
parties with respect to the subject matter hereof. This Agreement may not be
modified or amended except by an instrument or instruments in writing signed by
the party against whom enforcement of any such modification or amendment is
sought. Each party hereto may, by an instrument in writing, waive compliance by
the other party hereto with any term or provision of this Agreement on the part
of such other party to be performed or complied with. The waiver by either party
hereto of a breach of any term or provision of this Agreement shall not be
construed as a waiver of any subsequent breach.
13.08 Section Headings; Construction. The section headings and titles
contained herein are each for reference only and shall not be deemed to affect
the meaning or interpretation of this Agreement. The words "hereby", "herein",
"hereinabove". "hereinafter", "hereof' and "hereunder", when used anywhere in
this Agreement, refer to this Agreement as a whole and not merely to a
subdivision in which such words appear, unless the context otherwise requires.
The singular shall include the plural, the conjunctive shall include the
disjunctive and the masculine gender shall include the feminine and neuter, and
vice versa, unless the context otherwise requires.
13.09 Execution Counterparts. This Agreement may be executed in any
number of counterparts and each such duplicate counterpart shall constitute an
original, any one of which may be introduced in evidence or used for any other
purpose without the production of its duplicate counterpart. Moreover,
notwithstanding that any of the parties did not execute the same counterpart,
each counterpart shall be deemed for all purposes to be an original, and all
such counterparts shall constitute one and the same instrument, binding on all
of the parties hereto.
ARTICLE XIV. BINDING EFFECT, ASSIGNMENT
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information , has been replaced by "***" in this Exhibit.
16
Omitted portions of this Exhibit are subject to a Request for Confidential
Treatment under Rule 24b-2.
In entering into this Agreement, each party hereto has relied upon the
expertise and capabilities of the other. Accordingly, neither party may directly
or indirectly assign, delegate, encumber or in any other manner transfer any of
its rights, remedies, obligations, liabilities or interests in or arising under
this Agreement, without the prior consent of the other, which consent shall not
be unreasonably withheld or delayed. Any attempted assignment, delegation,
encumbrance or other transfer in violation of this Agreement shall be void and
of no effect, and shall be a material breach hereof.
IN WITNESS WHEREOF, the parties have cause this Agreement to be
executed as of the day and year first written above.
PLEXUS CORP. NEOPROBE CORPORATION
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxx X. Xxxx
------------------ -----------------
Name: Xxxxx Xxxxxxxx Name: Xxxxx X. Xxxx
--------------------- -------------
Title: Vice President Title: President, C.E.O.
-------------------- -----------------
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information, has been replaced by "***" in this Exhibit.
17
Omitted portions of this Exhibit are subject to a Request for
Confidential Treatment under Rule 24b-2.
EXHIBIT 1.13
PRODUCTS
--------
Plexus Part # Description Neoprobe Model #
------------- ----------- ----------------
*** *** ***
*** *** ***
Text which has been omitted and filed separately under Rule 24b-2, pursuant to
which Neoprobe Corporation has requested confidential treatment of this
information, has been replaced by "***" in this Exhibit.
