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
30 th 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)
|
Inspection of all components.
|
|
|
|
|
(ii)
|
Packing and crating, as required.
|
|
|
|
|
(iii)
|
Pre-shipment testing.
|
|
|
|
|
(iv)
|
Complete Device History Record
(“DHR”) paperwork to be maintained by
Encision.
|
|
|
|
|
(v)
|
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.
|
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 Intu