Exhibit 10.5
[*]
= Certain confidential information contained in this document, marked with
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment made
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
MANUFACTURING,
SUPPLY, AND LICENSE AGREEMENT
This Manufacturing,
Supply, and License Agreement (the “Agreement”) is made on this 30th day of March 2009,
(the “Effective Date”) by and between INTUITIVE SURGICAL INC.,
(hereinafter, “Intuitive”) a Delaware corporation with its principal place of
business located at 1266 Kifer Road, Sunnyvale, California 94086, and ENCISION, INC. (hereinafter, “Encision”), a
Colorado corporation with its
principal place of business located at 6797 Winchester Circle, Boulder, CO
80301. Intuitive and Encision hereby agree to the
following terms and conditions for the performance of this Agreement.
1. General Scope.
1.1 This Agreement contains the terms and
conditions which shall apply to any and all transactions for the manufacturing,
supply, and license by Encision, and purchase and use by Intuitive of goods for
use in or with Intuitive’s present and future lines of robotic surgical
systems, during the term hereof.
2. Definitions.
2.1 “Adverse Event” shall mean an event or incident that
led to a death, serious injury, or serious deterioration in the state of health
of a patient, user, or other person; if the incident was wholly or partially
caused by the Product or by shortcomings in the information supplied with the
Product.
2.2 “Bill of Materials” or “BOM” refers to the list of
Components necessary to manufacture the Product or Products.
2.3 “Certificate of Conformance” shall be written
certification by Encision, that the supplied Product meets the Specifications.
2.4 “Complaint” shall mean any written, electronic, or
verbal feedback directed to Intuitive and/or Encision, related to the use of a
medical device/Product/accessory manufactured or distributed by Intuitive, or
distributed by a third party on behalf of Intuitive, that alleges deficiencies
related to the identity, quality, durability, reliability, safety,
effectiveness, or performance of a Product after it is released for
distribution.
2.5 “Components” shall mean any components and other
materials listed in the Bill of Materials for any Product.
2.6 “Field” shall mean the diagnosis and/or treatment of a
human or an animal using Robotic Systems.
2.7 “Kanban Signal” shall mean a signal, electronic or otherwise,
used to trigger delivery of a set (Kanban) quantity against the quantity
specified in the Scheduling Agreement.
Intuitive will provide Kanban size to Encision.
2.8 “Product(s)” shall mean the item or items set forth in
Exhibit A to be purchased by Intuitive from Encision during the term of
this Agreement, including future revisions and enhancements and any additions
to the items set forth in Exhibit A that may be agreed upon by the
parties. For clarity, Products do not
include Intuitive Instruments.
2.9 “Robotic Systems” shall mean computer-controlled
manipulators used to diagnose and/or perform a medical or surgical procedure in
a patient’s body, controlled from a location external to the patient’s body.
Robotic Systems shall only include Intuitive’s present and future lines of da
Vinci Surgical Systems, instruments and accessories.
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2.10 “Scheduling Agreement” shall mean an order by
Intuitive, communicated via electronic data transfer, email or other means , to
purchase Products, Components, or other materials, at a stated unit price, for
a total quantity to be delivered within a delivery date range. Delivery due date will be determined based
upon Kanban Signal and the
Replenishment Lead Time.
2.11 “Specifications” are as set
forth in Exhibit B.
2.12 “Sterilization” shall refer
to both EtO (ethylene oxide) and Gamma (radiation isotope) sterilization
methods.
2.13 “Replenishment Lead Time” is the agreed
upon time to delivery from the Kanban Signal. Intuitive will provide the
Replenishment Lead Time.
2.14 “Licensed Patents” shall mean all worldwide patents
issued as of the date of this Agreement (including any and all patents issuing
or claiming priority from the above patents and patent applications, including
non-provisionals, continuations, continuations in part, divisionals,
re-examinations, reissues, and foreign counterparts thereof), owned or licensed
by Encision, necessary to develop, use, make, have made, promote, offer for
sale, sell, import, export, and otherwise commercialize Intuitive Instruments
that are enabled to function with Products, within the Field.
2.15 “Encision’s Intellectual Property” shall mean the
Licensed Patents and any and all now known or hereafter existing (a) copyrights,
moral rights, and mask works, (b) trade secret rights, (c) designs,
algorithms, and other industrial property rights, (d) trademark and trade name rights,
(e) other intellectual and industrial property and proprietary rights,
whether arising by operation of law, by contract or license, or otherwise, and (f) all
registrations, applications, renewals, extensions, combinations, divisions, or
reissues of the foregoing.
2.16 “Encision Inventions” shall mean Encision´s
inventions, whether patentable or not, patents, patent applications, know-how,
technical information, test results, and other intellectual property rights
conceived or reduced to practice solely by representatives of Encision in the
performance of this Agreement.
2.17 “Intuitive Inventions” shall mean Intuitive´s
inventions, whether patentable or not, patents, patent applications, know-how,
technical information, test results, and other intellectual property rights
conceived or reduced to practice solely by representatives of Intuitive in the
performance of this Agreement.
2.18 “Joint Inventions” shall mean any inventions whether
patentable or not, patents, patent applications, know-how, technical information, test results and any other intellectual
property rights conceived or reduced to practice jointly by representatives of
Encision and Intuitive in the performance of this Agreement.
2.19 “Purpose” shall mean the supply, design, installation,
adaptation, and certification of Products and Intuitive Instruments for use in
or with Robotic Systems solely within the Field.
2.20 “Intuitive Instruments” shall mean any instrument that is used,
in connection with Products, in or with a Robotic System.
3. Forecast.
3.1 Intuitive shall provide Encision with a non-binding
nine (9) to twelve (12) month rolling forecast of Intuitive’s delivery
requirements.
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3.2 This Agreement is not an authorization for Encision to
perform manufacturing services or to manufacture the Products. Intuitive will
place Scheduling Agreements or purchase orders with Encision in such a manner
that will provide Encision with Intuitive’s delivery requirements.
3.3 Intuitive may issue Scheduling Agreements or purchase
orders for a minimum of the first 90 days of the
required deliveries. Each Scheduling Agreement or purchase order shall include
a description of the Product(s) to be purchased, quantity, routing
instructions, requested delivery date, destination and price. Thereafter,
Intuitive will place Scheduling Agreements or purchase orders with Encision
based on agreed upon lead times and needed delivery dates.
4. Purchasing, Pricing and Payment Terms.
4.1 Purchase Order or Scheduling Agreement Acknowledgement. Encision shall acknowledge in writing purchase orders or
Scheduling Agreements submitted by Intuitive within seven (7) calendar
days from Encision receipt. In the event an acknowledgment is not received
within (7) calendar days, Intuitive may, at is option, cancel such
purchase orders or Scheduling Agreements with zero (0) financial liability to
Intuitive. Encision must submit in writing to Intuitive at the time of
Scheduling Agreement or purchase order acknowledgment any minimum order
quantity purchases or non-cancelable non-returnable’s (NCNR’s) that will result
in excess inventory.
4.2 Material Liability. Encision is
financially liable for any item on order, including NCNR’s, unless Encision has
received Intuitive’s written pre-approval.
Intuitive shall be liable
for the following:
(i) Finished goods: thirty (30) calendar days of demand*.
4.3 Flexibility. Intuitive may make changes to shipping instructions,
quantities or requested delivery dates/schedules specified in any Scheduling
Agreement or purchase order, as needed throughout the duration of this
Agreement, in conformance with Table 1.0 below, unless otherwise mutually
agreed upon in writing by the parties.
Table 1.0
Calendar days from
notice
|
|
% change
|
|
0 -
30
|
|
+/- [*]
|
|
31 -
60
|
|
+/- [*]
|
|
61 -
120
|
|
+/- [*]
|
|
121+
|
|
+/- [*]
|
|
4.5 Product Price and License Fees.
4.5.1 Price of Products. The intent of
the parties is for Encision to make [*] ([*]%) gross margin on the sale of
Products to Intuitive, plus a license fee as defined below in Section 4.5.2. The prices set forth in Exhibit A, which
shall be the prices as of the Effective Date of this Agreement, reflect a [*]%
gross margin for Encision. The parties agree to negotiate a commercially
reasonable annual price adjustment (up or down), bearing in mind the agreed
intention to maintain a [*]% gross margin for Encision. Failure to agree on the
pricing for the Products shall be deemed an event of mutual default, and shall
give either Party the right to terminate this Agreement as provided in the Term
and Termination Section of this Agreement. Given the intention for a [*]%
gross margin, the annual price shall be computed as Encision’s Cost of Goods
Sold for the Product divided by [*]%. “Cost
of Goods Sold” or COGS” shall mean the
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sum of (i) direct
materials cost (per the bill of materials), (ii) direct labor cost (for
the time to build the Product), (iii) burden cost (applied at standard
burden rate), and (iv) subcontract cost (if applicable, from bill of
materials on Products sent out for an outside operation), all to be determined
consistent with current US Generally Accepted Accounting Principles and
consistent with Encision’s practice for products of similar complexity with
Products.
4.5.2 License Fee. In addition to the Price of Products set
forth in Exhibit A and as defined in Section 4.5.1, Intuitive shall
pay a one time up front License Fee to Encision of [*] within 45 days of
signing this Agreement.
4.5.3 Cord Development Costs. Intuitive
shall also reimburse Encision for the following costs associated (to the extent
there are any and in an amount not to exceed [*]) with the Intuitive branded 12
foot cord product.
(a) Sterilization Validation
(b) Package Validation
(c) Shipping Tests
(d) Additional Dose Audits
(e) Validation for three (3) years
4.6 Price of Products purchased hereunder shall include,
without limitation, the following:
(i)
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Inspection of all
components.
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|
|
(ii)
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Packing and crating, as
required.
|
|
|
(iii)
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Pre-shipment testing.
|
|
|
(iv)
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Complete Device History
Record (“DHR”) paperwork to be maintained by Encision.
|
|
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(v)
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CE or other regulatory
labeling as required. The cost of any translation requested by Intuitive will
be paid by Intuitive, provided the cost is pre-approved by Intuitive.
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4.7 Payment. Intuitive will make payment upon receipt of a valid
and undisputed invoice. Payment for Products received shall be due net
forty-five (45) days from the date of Encision’s invoice.
4.8 Kanban Replenishment. Intuitive’s Kanban replenishment program requires the
Encision to ship an exact quantity of items to Intuitive within a specified
number of days after Kanban Signal to Encision.
Encision will be provided access to an internet portal that shows all
open Kanban Signals to be delivered to Intuitive. This portal will display
all parts that are to be shipped by Kanban scan number, Kanban quantity, and
due date. Encision is required to deliver in full Kanban quantities only,
unless otherwise approved in advance by Intuitive.
As feasible and
consistent with Encision infrastructure and business processes, Encision will
drive lean manufacturing concepts and best practices with Encision’s vendors to
maximize the effectiveness of the Kanban replenishment program for Intuitive.
Encision will also maximize its internal quality assurance efforts to ensure
that full Kanban stocking levels can be built and shipped to Intuitive, with
zero defect quality levels.
Encision and Intuitive
will define and agree on finished goods, work in process and raw material
liabilities to enable the Kanban replenishment program to be successful and
supportive of Intuitive needs. At a minimum, Encision shall always have a
minimum of one (1) Kanban bin in ready to ship, finished goods status.
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4.9 Certificate of Conformance. At Intuitive’s request, Encision shall
provide a Certificate of Conformance to Intuitive.
4.10 Audit. Encision
agrees to make and maintain complete and accurate records of its manufacturing
costs underlying its accounting statements provided to Intuitive, and shall
allow Intuitive, or its representative, a certified public accountant mutually
acceptable to Encision and Intuitive, during office hours and at reasonable
intervals, no more than once a year, to inspect and make extracts or copies of such
records solely for the purpose of ascertaining the correctness of such
statements, COGS and Product per unit prices. If any such examination and audit
shall disclose an overpayment of five percent (5%) or more, Encision shall pay,
in addition to such overpayment, the reasonable costs of such examination and
audit. All books of account and records
with respect to Products shall be kept available for at least five (5) years
after end of the Term.
5. Branding and Training.
5.1 Active Electrode Monitor (AEM) Branding.
Product may be Encision branded, provided Intuitive shall have the right
to determine the size and placement of the Encision branding, with input from
Encision. Intuitive approves the current
Encision branding of the AEM. Any changes to the branding of the AEM Product
shall require Intuitive’s approval.
5.2 Cord Branding. The cord
Product shall be Intuitive branded, with attribution provided to Encision. Intuitive will determine the messaging, size
and placement of the branding and attribution, with input from Encision
consistent with the parties’ respective intellectual property rights. Intuitive will pay for the cost of branding
the cord Intuitive.
5.3 Training. Encision
shall provide training to Intuitive personnel on use and operation of Products
and attendant safety measures as reasonably required and upon request of
Intuitive
5.4 No Other Purpose. Encision
shall not nor shall Encision enable or cause any other person to use or utilize
the Products for any purpose other than for Robotic Systems used within the
Field for which Intuitive would have sold the Products. For the avoidance of doubt, nothing in this Section or
Agreement shall be construed to preclude Encision from selling any of its
products, other than the Intuitive branded cord Product, to other parties.
6. Product Changes.
6.1 Product Changes. Intuitive may,
upon advance written notice to Encision, submit Engineering Changes for
incorporation into the Product(s). It is important that this notification
include documentation of the change to effectively support an investigation of
the Engineering Change (EC) impact. Encision shall, within a period not to
exceed twenty-five (25) calendar days from EC notification from Intuitive,
evaluate the feasibility of the EC and respond completely to Intuitive in
writing with the potential impact of the EC, including but not limited to,
current on-hand or on-order inventory, work-in-progress, the delivery schedule,
price, Product quality performance, and any other information with respect to
the EC requested by Intuitive. Encision’s response will be considered by
Intuitive to complete and release the EC and Encision will be notified of
actual EC through a change in Scheduling Agreement or purchase order for the
given Product(s) incorporating the EC change based upon a mutually agreed
upon switch-over date..
Encision shall not make
any changes to any Component (including manufacturing process), or to the
Product Specification process that may affect the performance of the Product or
the Product’s compatibility with Intuitive’s Robotic Systems unless approved by
Intuitive in writing before implementation.
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Encision will provide
Intuitive with detailed information of any proposed change in Product labels
and instructions for use that affect any sale or use of Products prior to its
implementation. Any proposed changes to Product labels and instructions for use
are subject to Intuitive’s review and approval.
6.2 Discontinued
Products and Components. Should Encision or any authorized supplier provide
notice that a Component used in the manufacturing of the Products is to be
discontinued, Encision will promptly notify Intuitive in writing of the
Products or Component being discontinued, the last date available for placement
of orders, the effective date the Product or Component will be discontinued,
and any last buy instructions or other applicable information or documentation
necessary for Intuitive to make an informed decision regarding any end of life
purchases for Products. Notwithstanding the above, no Product or Component
shall be discontinued without providing a minimum six (6) month notice
period in order to allow Intuitive the time to source replacement products
and/or components.
6.3 Obsolescence.
Encision agrees to provide sustaining engineering support, repair and
Component replacement of Product for a period of seven (7) years from the
date of Product obsolescence or discontinuation. Field replacement units (FRU’s) shall be of
either new or like new product.
7. Taxes.
7.1 Encision agrees to cooperate in a reasonable manner
with Intuitive in order to minimize all taxes that are to be paid directly or
indirectly by Intuitive. Encision agrees to use reasonable efforts to notify
Intuitive’s tax department of notice of any audit or assessment which may
affect the sales, use, excise, or property taxes which may be assessed on a
Product or Products, within fifteen (15) calendar days of receiving such
notice.
7.2 Intuitive has provided to Encision and Encision hereby
acknowledges having received Intuitive’s resale license/certificate.
8. Delivery.
8.1 Encision shall deliver Products in accordance with
Intuitive’s instructions as specified in each purchase order or Scheduling
Agreement. Delivery will be FCA Encision’s dock (Incoterms 2000). All Products
will be shipped to Intuitive with freight and insurance to be paid by
Intuitive.
8.2 Title and risk of loss will pass to Intuitive upon
shipment from Encision’s dock.
8.3 A complete packing list must accompany all shipments.
The following information shall be included in each packing list: Scheduling
Agreement or purchase order number, Intuitive’s part number and revision level,
the Kanban scan number, quantity, delivery date, and lot or serial number. This information
shall also be entered on the packing list in human readable barcodes.
8.4 If Encision uses transportation agents other than its
own resources, Encision is fully responsible and liable to ensure these
transportation agents support on time delivery requirements for the Kanban
replenishment program in accordance with Section 4.8 of this Agreement.
8.5 Intuitive shall have the right to approve packaging
and labeling.
8.6 In the event special transportation and storage
conditions are required for Products, Encision will provide Intuitive with
appropriate instructions in advance.
8.7 In the event Intuitive’s account number will be used
for freight, Encision will be subject to freight invoice audits on an ongoing
basis. Encision shall reimburse Intuitive for freight charges not related to
Intuitive’s shipping.
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9. Acceptance.
9.1 Intuitive shall have thirty (30) days from the date of
delivery to perform acceptance testing on Products received from Encision and,
shall have the right to return to Encision, for replacement, any Product that
fails such acceptance testing. Intuitive agrees to comply with Encision’s
reasonable return material authorization (“RMA”) procedures, including the
procurement of RMA numbers applicable to each Product return to Encision.
10. Delays.
10.1 Time is of the essence for Products ordered pursuant
to this Agreement and delivery shall be strictly in accordance with the
schedule set forth within the relevant Scheduling Agreement or purchase order.
Encision shall use its best efforts to minimize any delay that may prevent its
timely compliance with one or more requirements of this Agreement. Whenever the
delivery of Products shall be delayed for any reason, including any delays
caused by circumstances as set forth in Section 20 entitled “Force Majeure”,
Encision shall promptly notify Intuitive of Encision’s plan to remedy the
delay, including the anticipated length of the delay, the cause of the delay,
any measures proposed or taken to prevent or minimize the delay, and the
timetable for implementation of such measures. Should any delay continue for a
period more than eighteen (18) days, Intuitive shall be entitled, with written
notice to Encision, to terminate this Agreement without further obligation,
excluding payment for Products already delivered or in transit as of the date
of termination.
11. Reserved for future use.
12. Incoming Inspection and Process Control.
12.1 Incoming Inspections. Encision shall perform incoming quality control
inspections on all Components and will keep sufficient records such that the
source and raw material specification of such Components may be readily
determined. All records required under this Section 12.1, shall be
maintained by Encision for a period of five (5) years and/or provided to
Intuitive following termination of this Agreement.
12.2 Process Control. Encision shall follow documented processes during
assembly of the Products and keep written records of all assembly and tests
performed as determined by Encision’s Quality Systems Procedures.
13. Quality/Regulatory.
13.1 Encision agrees to maintain a quality system that is
in substantial compliance with USA FDA Quality System Regulations, Canadian Medical
Device Regulations, European Union Medical Devices Directives, ISO 13485: 2003
and Japan GQP (Good Quality Practices).
Intuitive understands that Japan GQP is currently in process but not
completed.
13.2 Encision agrees to share with Intuitive any FDA 483
observations or notified body non-conformities that affect Intuitive and to
allow Intuitive to participate in the resolution of the citation.
13.3 Encision agrees to notify Intuitive of any potential
changes to the device license or registration that could affect availability of
the Product.
13.4 Encision agrees to manufacture Product in compliance
with the device master record established by Intuitive and Encision.
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13.5 Each party will notify the other party of any FDA
regulatory actions, any FDA 483 observations or Warning Letters that were
issued, in addition to any pending or ongoing FDA investigations or inspections
that may involve the Encision or Intuitive six (6) months prior to the
Effective Date of this Agreement, and during the term of this Agreement.
Encision’s obligation is limited to Products as listed on Exhibit A.
13.6 Encision shall place the Product on hold and notify
Intuitive within two (2) business days if:
(i) A Product does
not meet Intuitive quality requirements and has been either certified for
shipment via DHR review and release (still held at Encision) or has already
shipped.
(ii) A finished
device meets Intuitive quality requirements, but an identified quality issue exists
which is not currently defined by Intuitive.
(iii) Encision is
notified of any supplier-related quality issue that may affect the
form-fit-or-function of finished products.
13.7 All Products provided to Intuitive under this
Agreement shall be manufactured in accordance with the Specifications, and
applicable to the relevant clauses of quality system regulations including: FDA
21 CFR 820, ISO 13485: 2003, and Japan GQP.
Encision will
exercise its appropriate control over the quality of the output from its
subcontractors, when applicable, and will maintain its own QMS covering such
control.
13.8 Inspection Rights/Subcontracting.
Intuitive shall have the right to have its representatives present at the
Encision plants and production facilities relating to or used in connection
with the manufacture of the Products during normal business hours to conduct an
initial inspection and periodic inspections of such plants and facilities and
the manufacturing procedures, the Product Specifications and Intuitive quality
assurance requirements and to inspect Encision’s inventory of Products,
work-in-process, raw materials to be used for the Products, production records
and such other matters or records as may be necessary to proper quality
assurance of the Products to be delivered hereunder. Intuitive agrees to give
Encision a minimum of two (2) business days’ prior notice of any such
inspection, whenever possible.
Encision shall promptly use its best efforts to take such action as is required to correct any deficiencies identified by Intuitive relating to the production of any Product listed in Exhibit A.
13.9 Regulatory
Matters. Encision shall maintain all
regulatory approvals it has for the Product and shall keep Intuitive informed
as to the status of all applicable regulatory approvals. Encision shall provide
Intuitive, upon request, a true and complete copy of all regulatory approvals
and other regulatory filings, submissions and communications for the Product(s) subject
to reasonable redaction of proprietary information. Encision shall provide support, assistance
and guidance to Intuitive with respect to Intuitive’s efforts to obtain other
regulatory approvals Intuitive may need for the Products or for Intuitive’s
products into which Product(s) are incorporated
13.10 Regulatory information
and notification with respect to the Product(s)Each party agrees to share and
provide to the other party all information related to regulatory approvals for
the Product(s), and without limitation agrees to maintain a reasonable record
of all material Complaints it receives with respect to the Product(s).
13.11
Regulatory information, notification and investigation with respect to
the Product(s). Each party agrees without limitation to:
(i) Maintain a Complaint handling process.
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(ii) Notify the other party of any material
Complaint received in sufficient detail and within thirty (30) days after
the end of the calendar quarter in which the event occurred.
(iii) Perform
a complete investigation within sixty (60) days, in response to any Complaint,
including a root cause analysis and formulate corrective action recommendations
to address the issues raised by such complaint. Results of the investigation
shall also be provided to the other party.
(iv) In the event a Complaint is received by
either party and the information reasonably suggests that (a) a death has
occurred, (b) the event resulted in a life-threatening illness or injury
(c) the event resulted in a permanent impairment of a body function or
permanent damage to a body structure, or (d) the event required medical or
surgical intervention to preclude permanent impairment of a body function
(including a clinically relevant increase in the duration of a surgical
procedure), or (e) remedial action was required to prevent an unreasonable
risk of substantial harm to public health, each party shall notify the other
party of the Complaint within two (2) business days of the receipt of the
Complaint to allow both parties sufficient time to comply with any and all
legal and regulatory requirements.
(v) In the event a
Complaint is received by either party involving a malfunction (i.e. failed to
meet its performance specifications as intended) for the Product(s), that if it
were to recur would likely cause or contribute to a death or serious injury
either party shall notify the other party of the Complaint within seven
(7) days of the receipt of the Complaint, to allow both parties sufficient
time to comply with any and all legal and regulatory requirements.
13.12 Each party shall notify the other party within two (2) calendar
days of becoming aware of any Adverse Event that has taken place and any
safety-related issue with respect to the Product(s). In such an event, each
party will, with the least practicable delay, provide the other party with
copies of advisory notices issued by related regulatory authorities to enable
both parties to take necessary actions in accordance with regulatory
requirements.
13.13 Records.
(i) Upon reasonable request from
Intuitive, Encision shall forward to Intuitive either a) copies of the
completed device history records or b) access to the completed device history
records.
(ii) Encision agrees to maintain
inspection and production batch records for a period no less than five
(5) years from the date the last Product is manufactured for Products
purchased by Intuitive.
(For finished goods
suppliers shipping to Japan, record requirement is fifteen (15) years.)
(iii) Upon request from either party, Complaint investigation
reports shall be provided to the other party for Products purchased by
Intuitive.
13.14 Recalls.
General. Encision shall have the exclusive right
(subject to applicable law) to initiate voluntary Product recalls, and shall
manage and be responsible (including bearing all costs and expense) for all
Product recalls. Each of the Parties hereto agrees to notify the other in
writing within forty eight (48) hours in the event either sees a need for a
potential Product recall.
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Encision
Recall. In the
event of any recall of any Product (whether voluntary, required by the FDA or
any other Governmental Authority in any jurisdiction in which Intuitive, any
Affiliate of Intuitive or any distributor of either has sold any Products, or
resulting from any device notification or safety alert) due to design defect,
workmanship or failure to manufacture in conformance with applicable Product
(or Device) Documentation or Device Regulation standards, or due to any other
defect or non-conformity in the Product (collectively, “Encision Recall”),
Encision shall (i) if requested by Intuitive, provide Intuitive with a
credit or reimbursement, or (ii) ) replace, refurbish or repair of defective
or non-conforming Products; and (ii) reimburse Intuitive for reasonable
costs and expenses incurred by Intuitive associated with (a) the initial
shipments of the recalled Products, and (b) customers’ return of the
recalled Products and shipment of replacement Products to customers.
Encision shall use its reasonable efforts to correct, as promptly as is
practicable, problems or other issues which result in Encision Recalls.
If any recall results solely from an act or omission of Intuitive or its agents
or employees, Intuitive shall reimburse Encision for its reasonable
out-of-pocket costs and expenses incident to such recall. Encision’s requested
out-of pocket costs for reimbursement are subject to Intuitive’s review and
approval.
13.16 Encision agrees to maintain required manufacturing
facility licenses as required by state and federal regulations.
13.17 Access to Technical
Materials. All Technical Materials
owned by Intuitive shall remain the property of Intuitive and all Technical
Materials owned by Encision shall remain the property of Encision. Encision shall use commercially reasonable
efforts to assist Intuitive with registration and regulatory requirements
13.18 Encision agrees not to modify the device master record
for the 12 foot cord, i.e;
(i) Device specifications including
appropriate drawings, composition, formulation, component specifications, and
software Specifications;
(ii) Production process specifications
including the appropriate equipment specifications, production methods,
production procedures, and production environment specifications;
(iii) Quality
assurance procedures and specifications including acceptance criteria and the
quality assurance equipment to be used;
(iv) Packaging and labeling specifications,
including methods and processes used; and
(v) Installation, maintenance, and servicing procedures
and methods, in a manner that would result in changing device safety,
performance or appearance without prior consent from Intuitive.
13.19 Encision shall assemble, test, and package the product
in accordance with a mutually approved device master record for the 12 foot
cord.
13.20 Encision shall ensure all required manufacturing and
inspection steps have been successfully completed, prior to delivering the
finished Product to Intuitive.
13.21 Encision shall be responsible for creating and
documenting manufacturing methods, inspections and processes to meet Product
Specifications.
13.22 Encision shall disclose and obtain prior consent from
Intuitive to use subcontract manufacturers. Encision agrees to notify Intuitive
of any significant changes to the facility, quality system, organization and
change of QMS certification status.
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13.23 Encision shall maintain ISO
13485:2003 certification. At Intuitive’s request, Encision shall provide copies
of ISO 13485:2003 certification and copies at every renewal of such
certification.
14. Representations and Warranties.
14.1 Encision warrants that all Products delivered
hereunder will: (a) conform strictly to the design specifications,
drawings, process documents, samples or other descriptions provided, (b) conform
strictly to the requirements of the relevant Scheduling Agreement or purchase
order, and (c) be free from defects in material and workmanship. Encision’s
warranty shall be in effect: (i) in the case of AEM Products, for a period
of one (1) year from date of acceptance from Intuitive; and (ii) in
the case of cord Product, until the label expiry date, or one use, whichever
occurs first.
14.2 If a Product or any Component is found by Intuitive,
after appropriate tests and inspections, to have any defect, including any
patent or latent defect, Intuitive will notify Encision in writing of such
defect and Encision will, at Encision’s election and at no cost to Intuitive,
either (1) repair or replace the defective Component or Product or (2) arrange
for the removal and replacement of the defective Product; provided however,
that if the Product has been incorporated by Intuitive into a larger product
assembly prior to the discovery of such defect, the parties shall confer as to
the means of effecting the repair or replacement most convenient for Intuitive
which is not unduly burdensome to Encision, and proceed accordingly. Encision
will retain any Components removed from the Product for replacement. Components or Component parts furnished in
warranty service shall be new or rebuilt parts, at the option of Encision, but
in either case shall be of the same quality and subject to the same warranty as
new parts. In any case, the warranty period of any parts furnished under
warranty service shall not exceed the warranty period of the original parts or
ninety (90) days from the date of delivery of any repair, reconditioned, or
replacement thereof, whichever is longer.
14.3 Warranty Exclusions.
The warranty set forth above excludes and does not apply to defects (i) caused
through not fault of the Encision during shipment to or from Intuitive, (ii) caused
by modifications or alterations made to Products by Intuitive or a third party
not approved by Encision, (iii) caused by unauthorized repair or
maintenance of Products by Intuitive or any third party not approved by
Encision, (iv) caused by the failure of Intuitive to comply with the
return procedures specified herein, or (v) damaged by excessive current,
temperature, physical stress or other deviation from the applicable
environmental specifications.
14.4 Warranty Procedures.
Intuitive shall request authorization from Encision prior to the return
of each defective Product for repair or replacement by Encision. Upon such request, Encision shall provide the
address of the facility to which such Product shall be returned, together with
Return Material Authorization (RMA) tracer number.
14.5 Warranty Disclaimer.
THE EXPRESS WARRANTY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL
OTHER GUARANTIES AND WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED OR
STATUTORY, INCLUDING WITHOUT LIMITATION, MERCHANTABILITY, FITNESS FOR
PARTICULAR PURPOSE, NON-INFRINGEMENT.
ALL SUCH OTHER WARRANTIES ARE HEREBY DISCLAIMED AND EXCLUDED BY
ENCISION.
14.6 Mutual Representations and Warranties. Each party represents and warrants that it
has full right, power, and authority to enter into this Agreement and to
perform its obligations and duties under this Agreement, and that the
performance of such obligations and duties does not and will not conflict with
or result in a breach of any other agreements of such party or any judgment,
order, or decree by which such party is bound.
14.7 Specific Disclaimer.
Other than as specifically set forth herein, nothing in this Agreement
will be construed as giving rise to: (a) a warranty or representation by
Encision as to the validity, enforceability, or scope of the Licensed Patents; (b) a
warranty or representation that using, making, selling, or importing a Licensed
Product as permitted under this Agreement will not infringe,
11
directly or indirectly,
any patent or other intellectual property right of a third party under the laws
of the United States or any other jurisdiction; (c) an obligation by
Encision to file, register, prosecute, maintain, or enforce any Licensed
Patent; or (d) an obligation by Encision to deliver any technical or
proprietary information or know-how or to provide any training or technical
support other than as provided for in Section 5.3 or as mutually agreed
upon by the Parties.
15. Intellectual Property and License.
15.1 Encision hereby grants Intuitive:
(i) a non-exclusive (without the right to sub-license),
royalty-free, worldwide license under Encision’s Intellectual Property to, use,
promote, offer for sale, sell, import, and export Products within the Field,
and
(ii) a non-exclusive (without the right to sub-license),
royalty-free, worldwide, perpetual license under Licensed Patents to develop,
use, make, have made, promote, offer for sale, sell, import, export, and
otherwise commercialize Intuitive Instruments within the Field.
15.2 Encision hereby agrees not to use any technology or
intellectual property rights that are owned or controlled by any third party in
the course of manufacturing the Product, unless Encision has the right to use
such technology and/or intellectual property in the manufacture of the Product
and Encision notifies Intuitive of such intended use in advance and Intuitive
approves such use. Any additional terms or licenses required for the use of
such intellectual property shall be provided to Intuitive for review and
approval in writing, before acceptance of such Product
15.3 Upon the execution of this Agreement, Encision shall
provide to Intuitive the drawings, specifications and CAD drawings for the AEM®
connector so that Intuitive can configure the Intuitive Instruments to be
compatible and interconnect with Encision’s cord.
15.4 Ownership of Intellectual Property.
15.4.1 Intuitive Inventions shall be owned exclusively by
Intuitive.
15.4.2 Encision Inventions shall be owned exclusively by
Encision, with Intuitive having a non-exclusive, royalty free license to the
Encision Inventions solely within the Field.
15.4.3 Joint Inventions shall be owned by Intuitive with
Encision having an exclusive, royalty free license under the Joint Inventions
outside of the Field.
15.5 Except as set forth in this Section 15, nothing
in this Agreement is intended to convey any rights to any intellectual property
owned by either party as of the Effective Date or developed during the term of
the Agreement.
15.6 Restrictions on Use. Intuitive
acknowledges that the Encision Intellectual Property including any structure,
organization, manufacturing methods, and Source Code, contain valuable trade
secrets of Encision. Accordingly, other
than in connection with the Purpose and Intuitive’s rights and obligations
under the terms of this Agreement, Intuitive agrees not to (a) modify, adapt,
alter, translate, or create derivative works from the Encision Intellectual
Property; (b) sublicense, lease, rent, loan, or otherwise transfer the
Encision Intellectual Property to any third party, (c) reverse engineer,
decompile, or disassemble the Encision Intellectual Property; or (d) otherwise
use or copy the Encision Intellectual Property except as expressly allowed
under the terms of this Agreement.
15.7 Patent Marking. Intuitive
shall mark all Intuitive Instrument packages using Licensed Patents in
accordance with 35 U.S.C. § 287 with the number of each of the issued patents
included in the Licensed Patents and indicate that the Product has been made
under a license from Encision. Intuitive
shall
12
provide a sample of each
patent marking label to Encision for inspection and approval, which approval
shall not be unreasonably withheld.
16. General Indemnification.
16.1 Indemnification by Encision. To the extent allowable by law, Encision
hereby assumes all liability for, and agrees to indemnify, defend and hold
harmless Intuitive and its successors, permitted assigns, agents and employees
from and against, any and all liabilities, losses, damages, claims and expenses
(including attorneys’ fees, expert witness fees, and court costs) to the extent
that they arise from third party claims, actions or demands including without
limitation, claims arising in contract or tort (including negligence), strict
liability or otherwise (collectively, “Claims”) in any way relating to or
arising from (a) Encision’s breach of any of its representations or
warranties or any other obligation hereunder, (b) Encision’s negligence or
willful misconduct, or (c) infringement by Encision’s Product of a third party
intellectual property right; provided that Encision’s indemnification
obligations under this Section 16.1 shall not apply to the extent that
such Claims arise from (i) Intuitive’s negligence or willful misconduct; (ii)
Intuitive’s breach of any of its obligations hereunder; or (iii) Intuitive’s
use of Product outside of the Field.
16.2 Indemnification by Intuitive. To the extent allowable by law,
Intuitive hereby assumes all liability for, and agrees to indemnify, defend and
hold harmless Encision and its successors, permitted assigns, agents and
employees from and against, any and all liabilities, losses, damages, claims
and expenses (including attorneys’ fees, expert witness fees, and court costs)
to the extent that they arise from third party claims, actions or demands
including without limitation, claims arising in contract or tort (including
negligence), strict liability or otherwise (collectively, “Claims”) in any way
relating to or arising from (a) Intuitive’s breach of any of its
representations or warranties or any other obligation hereunder, (b) Intuitive’s
negligence or willful misconduct, or (c) any activities of Intuitive
beyond or outside of the Purpose; provided that Intuitive’s indemnification
obligations under this Section 16.2 shall not apply to the extent that
such Claims arise from Encision’s negligence or willful misconduct or breach of
any of its obligations hereunder.
16.3 Claim Notification Requirement. An indemnifying party will use reasonable
efforts to notify the indemnified party promptly of the claim as soon as the
indemnified party becomes aware of it.
However, an indemnified party’s failure to provide such notice or delay
in providing such notice will relieve the indemnifying party of its obligations
under this Section only if and to the extent that such delay or failure
materially prejudices the indemnifying party’s ability to defend such claim. The
indemnified party will have the right to participate in the defense of such
claim with its own counsel and at its own expense. The indemnified party will cooperate with the
indemnifying party, at indemnifying party’s reasonable request and at the
indemnifying party’s expense, in the defense of such claim. No settlement of a claim will be binding on
indemnified party without the indemnified party’s prior written consent, which
shall not be unreasonably withheld or delayed.
17. Limitation of Liability.
17.1 EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY
OBLIGATIONS SET FORTH IN SECTION 23 AND THE INDEMNITY OBLIGATIONS OF SECTION 16,
IN NO EVENT, WHETHER AS A RESULT OF BREACH OF CONTRACT, WARRANTY, TORT
(INCLUDING NEGLIGENCE), STRICT LIABILITY, OR OTHERWISE, SHALL EITHER PARTY OR
ITS AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY
INCIDENTAL DAMAGES, EXEMPLARY DAMAGES, PUNITIVE DAMAGES, INDIRECT OR
CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS), OR LOSS OF BUSINESS,
RECORDS, DATA, USE, REVENUE, OR ANTICIPATED SAVINGS, OR OTHER ECONOMIC LOSS,
WHETHER OR NOT THE PARTY OR ITS AFFILIATES WERE INFORMED OR AWARE OF THE
POSSIBILITY OF SUCH DAMAGES OR LOSS. SOME JURISDICTIONS DO NOT ALLOW THE
LIMITATION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES; IN SUCH
13
JURISDICTIONS, THE
FOREGOING LIMITATION OF LIABILITY SHALL APPLY ONLY TO THE EXTENT PERMITTED BY
LAW.
18. Governing Law/Jurisdiction.
18.1 The laws of the State of California shall govern the
provisions of this Agreement without reference to its conflict of law
provisions. The parties agree that the United Nations Convention on Contracts
for the International Sale of Goods shall not apply to this Agreement. Each
party hereby consents and submits to the exclusive jurisdiction of the State
and Federal courts sitting in Santa Clara County, California, and hereby agrees
that venue of any dispute which arises hereunder is proper, appropriate and
acceptable in these state and federal courts. The prevailing party to any legal
action shall be entitled to reimbursement of all reasonable costs and expenses
(including attorneys’ fees) incurred to defend such claim.
19. Term and Termination.
19.1 Term. This
Agreement will commence upon the Effective Date of this Agreement and shall
continue in effect for a period of five (5) years (the Initial Term),
unless sooner terminated as specified in this Section 19. Thereafter, this
Agreement shall automatically renew for additional two (2) year periods
(each a “Renewal Term”), unless one party notifies the other in writing at
least six (6) months before the expiration of its intent not to renew the
Agreement.
19.2 Termination. Either party may terminate this Agreement
upon written notice to the other party if (i) a party materially breaches
this Agreement and does not cure the breach within thirty (30) days of the date
of written notice of such breach;, (ii) a
party becomes insolvent or seeks protection under any bankruptcy, receivership,
trust deed, creditors arrangement, or comparable proceeding or if any such
proceeding is instituted against a party and not dismissed within ninety (90)
days; (iii) an assignment or
attempted assignment in violation of the assignment provision of this
Agreement; or (iv) Encision is otherwise unable or unwilling to supply
Products to Intuitive pursuant to the terms of this Agreement.
19.3 Effect of
Termination-Last Time Buy Order.
Upon the expiration or termination of this Agreement for any reason,
Intuitive shall have the right to, within sixty (60) days from the date of
expiration or termination, place a Last Time Buy Order with Encision for
Products in quantities not more than 2 times the last nonbinding 12 month
forecast Intuitive provided to Encision pursuant to Section 3.1 (“Last
Time Buy Quantity”) with a delivery schedule generally consistent with the
previously agreed upon lead times, delivery dates and other delivery
obligations. In the event of termination
subject to Section 19.2 or in the event Encision is otherwise unable or
unwilling to fulfill the Last Time Buy Order, then Encision shall transfer to
Intuitive those portions of Encision’s Intellectual Property necessary to
manufacture or have manufactured the Product to ensure that Intuitive gets
continued supply of Product up to the Last Time Buy Quantity or until
Encision is able to resume manufacturing Products for Intuitive, which shall
be determined at Intuitive’s reasonable and good faith discretion and
in accordance with Encision’s prior supply obligations under this
Agreement. In connection with such
transfer of Encision’s Intellectual Property, Encision shall and hereby grants
Intuitive a limited, non-exclusive license to such Intellectual Property for
the sole purpose of enabling Intuitive to make or have made the Products. If the Parties subsequently agree to allow
Encision to resume manufacturing and supply, this Agreement shall be deemed
reinstated and thereafter in full force and effect, without any further action
required by either Intuitive or Encision. Upon any such reinstatement, any and
all licenses and other rights granted under this Section 19.3 shall
immediately terminate and Intuitive shall return and/or destroy all copies of
Encision’s Intellectual Property transferred under the terms of this
Section. Any such expiration or
termination shall not constitute a cancellation of open Scheduling Agreements
or purchase orders.
19.4 Termination of this Agreement shall not limit either
party from pursuing other remedies available to it, including injunctive
relief, nor shall such termination relieve Encision of its obligation to
immediately deliver to Intuitive any Products owed by Encision under any
Scheduling Agreement or
14
purchase order, order
form or invoice, minus any amounts paid or payments, deposits and installments
made by Intuitive, or in transit, prior to the date of termination.
19.5 Upon the expiration or termination of this Agreement
for any reason, and subject to the provisions in Sections 19.3 and 15.1(ii),
all licenses granted under this Agreement shall be revoked and Intuitive shall
cease all further use, manufacture, sale, offer for sale, exportation or
importation of the Products and the Encision Intellectual Property. Nothing in this section shall be construed to
prohibit Intuitive from using, selling, offering for sale, importing or
exporting any Products supplied under the terms of this Agreement prior to any
termination or supplied pursuant to Section 19.3.
20. Survival.
20.1 Each party’s rights and obligations under Sections 4.5
(Price), Section 4.7 (Payment), 6.3 (Obsolescence), 14 (Representations
and Warranties), 15.1(ii), 15.4 (Ownership of Intellectual Property), 16
(General Indemnification.), 17 (Limitation of Liability) 18 (Governing
Law/Jurisdiction), 19 (Term and Termination), 22 (Compliance with Law), 23
(Confidentiality/Nondisclosure), 24 (Assignment.), 25 (General), and any
provision which by its nature should survive, shall survive termination of this
Agreement.
21. Force Majeure.
21.1 Neither party shall be held responsible for any delay
or failure in performance of any part of this Agreement to the extent such
delay or failure is caused by fire, flood, earthquake, explosion, war, embargo,
government requirement, civil or military authority, act of nature, riot,
strike, hostilities (including war, whether declared or not) or other similar
cause beyond its control and without the fault or negligence of the delayed or
non-performing party.
22. Compliance with Law.
22.1 In the performance of this Agreement, Encision shall
at all times comply with all applicable governmental laws, statutes,
ordinances, rules, regulations, orders, and other requirements, including,
without limitation, the maintenance of a quality system and DHR (Device History
Records) as required by 21 CFR 820 and other such governmental requirements
applicable to environmental protection, wages, hours, equal employment
opportunity, nondiscrimination, health, safety, working conditions, export
control regulations, customs laws, and transportation regulations. In the event that Intuitive’s assistance is
necessary to achieve such compliance, Encision shall promptly notify
Intuitive. Upon Intuitive’s request,
Encision shall provide Intuitive with documentation demonstrating Encision’s
compliance with such government’s requirements.
After reasonable notice and under reasonable conditions, Intuitive shall
have the right to inspect and copy any of Encision’s records regarding such
compliance.
23. Confidentiality/Nondisclosure
23.1 During the term of this Agreement the parties may
receive and otherwise be exposed to confidential and proprietary information
relating to each other’s business practices, strategies, and technologies. Such
confidential and proprietary information may include but not be limited to
confidential and proprietary information supplied with the legend “Confidential
and Proprietary,” or equivalent, including information relating to products,
processes, know-how, designs, drawings, clinical data, test data, formulas,
source and object code, methods, samples, developmental or experimental work,
improvements, discoveries, plans for research, new products, forecasts,
Scheduling Agreements, purchase orders, specifications relating to Components
and Products, financial, customer or other information, normally considered to
be confidential, manufacturing, and all derivatives, improvements and
enhancements to any of the above which are created or developed under this
Agreement and information of third parties (collectively referred to as “Proprietary
Information”).
15
23.2 Each party shall maintain all Proprietary Information
in trust and confidence and shall not disclose any Proprietary Information to
any third party or use any Proprietary Information for any unauthorized
purpose. Each party may use such Proprietary Information only to the extent
required to accomplish the purposes of this Agreement. Proprietary Information shall not be
reproduced in any form except as required to accomplish the purposes of this
Agreement.
23.3 All Proprietary Information (including all copies
thereof) shall remain the property of the disclosing party and shall be
returned to the disclosing party after the receiving party’s need for it has
expired, or upon request of the disclosing party, and in any event, upon
completion or termination of this Agreement.
23.4 The termination of this Agreement shall not relieve
either party of the obligations imposed by Paragraphs 23.1 through 23.3 of this
Agreement with respect to Proprietary Information. Each party shall agree to
hold information confidential for a period of five (5) years after the
date of last disclosure or five (5) years after the termination of this
Agreement, whichever is shorter.
23.5 The parties shall not disclose the existence of this
Agreement or its terms to others, except as may be necessary to enforce the
terms of this Agreement, or as such party will deem necessary to comply with
any disclosure or legal requirement.
23.6 Each party agrees not to disclose to the other party
the confidential or proprietary information of others.
23.7 Notwithstanding the foregoing, Proprietary Information
shall not include any information that:
(a) becomes generally available to the public
other than as a result of a disclosure by the receiving party;
(b) was available to the receiving party on a
non-confidential basis prior to the disclosure;
(c) becomes available to the receiving party
on a non-confidential basis from a source other than the disclosing party or
its agents, advisors, or representatives which such source is entitled, to the
best of the receiving party’s knowledge, to make the disclosure; or
(d) is independently developed by employees
of the receiving party without reference to or use of such Proprietary
Information.
23.8 Publicity. Neither party
shall publish or submit for publication any document or press release, whether
in written, electronic or other form, nor make any public announcement or
presentation that discloses information about the existence or terms of this
Agreement or transactions thereof, without the other party’s prior written
consent. Such consent from Intuitive
shall not be unreasonably withheld.
24. Assignment.
24.1 Encision shall not assign
any of its rights or obligations hereunder in whole or in part, without the
prior written consent of Intuitive (which consent shall not be unreasonably
withheld), whether or not as incident to a merger, consolidation, reorganization
or acquisition of stock or assets or a similar transaction affecting all or
substantially all of the assets or voting control of the Encision. Any
attempted assignment in violation of this provision shall be null, void and
without legal effect.
16
25. General.
25.1 Waivers. No waiver of any right by either party
under this Agreement shall be of any effect unless such waiver is express, in
writing and signed by the waiving party. Any purported waiver not consistent
with the foregoing shall be void.
25.2 Severability. If any provision of this Agreement is
held by a court of competent jurisdiction to be invalid under any applicable
statute, rule or law, the parties agree that such invalidity shall not affect
the validity of the remaining provisions of the Agreement, and further agree to
substitute for the invalid provision a valid provision that most closely
approximates the intent and economic effect of the invalid provision.
25.3 Headings. Headings used in this Agreement are provided for
convenience only, and shall not in any way affect the meaning or interpretation
hereof.
25.4 Notices. Any notices given under this Agreement must be in
writing and shall be deemed given and received five (5) days after the
date of mailing, one (1) day after dispatch by overnight courier service,
or upon receipt if by hand delivery. Any notices pursuant to this Agreement
shall be sent to Intuitive or Encision at the addresses as set forth below.
Each party may change its address for receipt of notices by giving the other
party notice of the new address.
(a) If to Encision, to:
Encision Inc.
6797 Winchester
Circle
Boulder, CO 80301
Attention: Jack
Serino, President & CEO
Facsimile
No.: 303-339-6939
E-mail:
jserino@encision.com
With a required
copy to:
Neugeboren O’Dowd
PC
1227 Spruce St., Suite 200
Boulder, CO 80302
Attention: Craig Neugeboren, Esq.
Facsimile
No.: 720-536-4910
E-mail: craig@neugeborenlaw.com
(b) If to Intuitive, for operational issues
related to the contract:
Intuitive Surgical, Inc.
1266 Kifer Road
Building 101
Sunnyvale,
California 94086-5304
Attention:
Materials Management
Facsimile
No.: 408-523-1390
E-mail: [*]
with required
copies to each of the following:
Office of General
Counsel — Legal Department
Or at such other
address for a Party as shall be specified by like notice.
Each party shall promptly
notify the other of a replacement of the contact person responsible for prompt
transmission of information in order to comply with Good Quality Practice (GQP)
Ordinance. (Only for finished goods suppliers shipping to Japan).
17
25.5 Insurance. Encision shall
obtain and maintain throughout the term of the Agreement, Commercial General
Liability Insurance including coverage’s for contractual liability, product
liability, personal injury and bodily injury in an amount not less than
$1,000,000 per occurrence/$3,000,000 aggregate. Encision shall furnish
Intuitive with a certificate of insurance evidencing the coverage’s as outlined
above upon execution of this Agreement. Encision shall carry Workers’
Compensation Insurance as required by California State Law.
25.6 Relationship of
the Parties. The
parties understand and agree that their relationship hereunder is one of
contract and that they are not and shall not be construed as partners, joint
ventures, or agent and principal. In no event shall either party be authorized
to act for or on behalf of the other party.
25.7 Costs. Except as otherwise specifically
provided herein or as agreed to by the Parties, each party shall bear its own
costs and expenses incurred in connection with the performance of its
obligations hereunder.
25.8 Taxes. Any taxes, levies or similar
governmental charges, now in force or enacted in the future, however,
designated (“Taxes”) including related penalties and interest, imposed by any
governmental authority on or measured by the activities described herein shall
be paid by Intuitive in addition to the prices invoiced. Intuitive shall pay,
or reimburse Encision for the payment of all Taxes including related penalties
and interest, except Taxes for which Intuitive has provided a certificate of
exemption or resale acceptable to both Encision and the appropriate taxing
authority.
25.9 Counterparts. This Agreement may be executed in
multiple copies, each of which shall be deemed an original, and all of which taken together will constitute one
single agreement.
25.10 Specific Performance. Encision
acknowledges and agrees that any breach of certain of Encision’s obligations
under this Agreement, including without limitation Encision’s obligations under
Sections 6.2, 6.3, 19.3 and 24 herein, will cause irreparable harm to Intuitive
for which monetary damages will not be adequate remedy. Encision therefore agrees that Intuitive
shall be entitled (without limitation of any other rights or remedies otherwise
available to Intuitive) to specific performance without posting a bond.
25.11 Entire
Agreement; Amendment. This Agreement sets forth the
entire agreement between Intuitive and Encision with respect to the subject
matter hereof and supersedes any prior agreements, understandings promises and
representations made orally or in writing by either party, to the other party,
concerning the subject matter herein, pricing and the applicable terms. Any terms or conditions
contained in any Scheduling Agreement or purchase order, acknowledgement,
invoice or other similar forms of the parties which are different from,
inconsistent with or in addition to the
terms and conditions of this Agreement shall be void and of no effect, unless otherwise mutually agreed to in writing
by the parties. This Agreement may be amended only in
writing, signed by both parties. Any
purported oral modification intended to amend the terms and conditions of this
Agreement shall be void.
Upon signing below he/she
acknowledges that they have read, understand and agree to be bound by the terms
and conditions of this Agreement.
In
Witness whereof,
the undersigned represents that he/she has the authority to bind his or her
party to this Agreement.
18
ACCEPTED BY:
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ACCEPTED BY:
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INTUITIVE SURGICAL, INC.
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ENCISION,
INC.
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By:
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By:
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Name:
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Name:
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Title:
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Title:
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Date:
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Date:
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19
EXHIBIT A
PRODUCT
LIST/PRICING
Product description
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Encision
Part number
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Intuitive
Part Number
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$ Price (per
Unit)
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CE and 510K
approvals
responsibility of
Encision or
Intuitive.
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EM2+
Active Electrode Monitor
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[*]
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Encision
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EM2+A
Active Electrode Monitor
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[*]
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Encision
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EM2+AHF
Active Electrode Monitor
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[*]
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Encision
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EM2HF
Active Electrode Monitor
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[*]
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Encision
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EM2AB
Active Electrode Monitor
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[*]
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Encision
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EM2+E
Active Electrode Monitor
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[*]
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Encision
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ES9005
Active Adapter
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[*]
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Encision
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12
ft Cord, to connect AEM® to Intuitive instrument
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[*]
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Encision
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20
EXHIBIT B
SPECIFICATIONS
· [*]
· [*]
· [*]
· [*]
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[*]
#
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1
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2
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[*]
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3
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4
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[*]
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5
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[*]
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