[NOTE:
CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL INFORMATION HAS BEEN OMITTED. CONFIDENTIALITY HAS BEEN
REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE CONFIDENTIAL
PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECURITIES AND
EXCHANGE COMMISSION]
SUPPLY AND DISTRIBUTION
AGREEMENT
#06-OEM-VC-EV-JLB
THIS AGREEMENT
is made as of this 16 th day of March 2006, between General
Electric Medical Systems Scs (“GEHC”), a
corporation organized under the laws of France, with its principal
place of business at 283 Rue de la Minière, 78533 Buc Cedex,
France acting on its own behalf and on behalf of the Healthcare
divisions of the General Electric Company and their affiliates and
Volcano Corporation (“VC”), a corporation
organized under the laws of Delaware, USA with its principal place
of business at registered office and its principal place of
business at 2870 Kilgore Road, Rancho Cordova, CA 95670, USA, (each
of GEHC and VC, a “Party” and together the
“Parties”).
WHEREAS, VC is
engaged among other things in the design, development,
manufacturing, sales through distributors of directly to end users
of Intravascular Ultrasound systems trademarked as
“s5i” (hereinafter referred to as “IVUS”)
imaging systems and catheters that are used in conjunction with
Cardiovascular Imaging systems and are designed to help the
interventionalists in assessing coronary diseases and assisting
them in the planning and guiding of Percutaneous Coronary
Interventions (“PCI”) such as stent placement
procedure; and
WHEREAS, GEHC
is engaged among other things in the design, development,
manufacturing, sales through distributors or directly to end users
of Cardiovascular systems; and
WHEREAS, VC and
GEHC desire to collaborate to develop a unique and important IVUS
imaging system with specific integration between operation of the
GEHC Cardiovascular system (cath lab) and software and the IVUS
imaging equipment and software. With a successful partnership, VC
should benefit from additional distribution leverage provided by
GEHC and GEHC should benefit by offering a differentiated product
offering as compared to its competitors.
WHEREAS, VC
agrees to use its experience and expertise to develop and,
manufacture and support the Products (as defined below) for GEHC in
accordance with the terms and conditions more fully set forth in
this Agreement and GEHC wishes to distribute the Products under VC
trademarks, all subject to the terms and conditions set forth
below; and
WHEREAS, in
recognition of anticipated dedication of resources of GEHC, VC
wishes to appoint GEHC to exclusively distribute a specially
integrated version of the s5i systems (such special integrated
version referred to herein as the “s5i/GE”), in the
Territory (as defined below) and for a limited period, and GEHC is
willing to accept such appointment, on the terms and conditions set
forth below.
WHEREAS, VC
also wishes to appoint GEHC to non-exclusively distribute certain
versions of the s5i system, in the Territory (as defined below) and
for a limited period, and GEHC is willing to accept such
appointment, on the terms and conditions set forth
below.
NOW THEREFORE,
VC and GEHC agree as follows:
All capitalized
terms will have the meanings ascribed to such terms in this
Article 1 or as otherwise defined herein.
“ CE
Marking ” will mean the European Union CE Marking as
described in EC Medical Directive 93/42 of June 14,
1993.
Product
Introduction shall mean
GEHC M3 Milestone sign off as defined in Section 2.2 and
GEHC’s first commercial shipment and installation of a s5i/GE
unit (Pilot #1)
“Delivery” shall mean, except as otherwise agreed in
writing by the Parties in the Purchase Orders, Ex-works Rancho
Cordova, CA, USA.
“End
User” will mean any
GEHC customer who uses the Products.
“
FDA ” will mean the United States Food and Drug
Administration.
“
Files for Bankruptcy ” will mean, with respect to an
entity, if any of the following events occurs: such entity
(a) voluntarily becomes the subject of any proceedings
relating to its winding-up, liquidation, insolvency or for the
appointment of a receiver or similar officer for it,
(b) involuntarily becomes the subject of any proceedings
relating to its winding-up, liquidation, insolvency or for the
appointment of a receiver or similar officer for it, which is not
discharged in its favor with prejudice within ninety (90) days
thereafter; (c) makes an assignment for the benefit of all or
substantially all of its creditors, or enters into an agreement for
the recomposition, extension or readjustment of all or
substantially all of its obligations; (d) has filed against
it, a petition or other document seeking relief under bankruptcy
laws, which is not discharged with prejudice within ninety
(90) days thereafter; or (e) a temporary or permanent
receiver or liquidator is appointed over the Company or
substantially all its assets and such appointment is not cancelled
within ninety (90) days thereafter.
“ GEHC
Group ” will mean the group of entities, controlled
directly or indirectly by General Electric Company, which is
involved in the medical business of research, development,
manufacture, distribution or service of medical
equipment.
“ GE
Policies ” shall mean GEHC policies set out in GE
Integrity Policy Principles attached hereto as Attachment E,
including without limitation: Policies 20.4 — Ethical
Business Practices; 20.5 — Compliance with Antitrust Laws;
20.3 — Health Safety and Environmental Protection; 20.9
— Following International Trade Controls; 20.10 —
Working with Government Agencies; 20.11 — Customer
Satisfaction; 30.5 — Avoiding Conflicts of Interest, and
Money Laundering Prevention, as said Policies may be modified from
time to time, and any other Policies communicated by GEHC from time
to time in writing to VC.
“
Products ” shall mean the Intravascular Ultrasound
systems s5i and the s5i/GE trademarked by VC to be used in
conjunction with Cardiovascular Imaging systems and
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designed to
help the interventionalists (Cardiologists and Radiologists) in
assessing coronary diseases and assisting them in the planning and
guiding of Percutaneous Coronary Interventions (“PCI”)
such as stent placement procedure as further described in
Attachment A hereto and customized for GEHC, that GEHC elects to
distribute.
“
s5i/GE ” product shall mean a set of individual IVUS
imaging system components (CPU, control stations, monitors, etc.)
which are both a) installed directly into the cath lab on a
permanent (non-mobile) basis and b) able to be integrated with GE
Innova systems allowing the control of the IVUS imaging system
directly from the GE X-ray cath lab system by a GE Touchscreen-type
integrated cath lab control station (known as the GE Innova
Central) as further defined in Section 2.1.
“
s5i ” shall mean a set of individual IVUS imaging
system components (CPU, control stations, monitors, etc.) which are
installed directly into the cath lab on a permanent (non-mobile)
basis but which are not able to be controlled directly from the
cath lab by a GE Touchscreen-type integrated cath lab control
station (GE Innova Central). For the avoidance of doubt, the s5i
shall include IVUS systems integrated into the cath lab that have a
bedside control panel of any number of form factors that is not
specifically linked to operation of the basic functions of the cath
lab system and gantry as further defined in
Section 2.1.
“
Term ” will mean the term of the Agreement specified
in Article 23.
“
Territory ” will mean all the countries and
territories in the world except Japan
“Customer Satisfaction
Opportunity” (CSO) shall mean an End User complaint due
to a performance or quality issue arising on a Product.
“Product Quality Report”
(PQR) shall mean a significant
quality, reliability or technical issue arising on the Product that
do not have safety or regulatory impact
“Product Safety Report”
(PSR) shall mean a safety or
regulatory issue arising on the Product.
ARTICLE 2.
SCOPE OF THE AGREEMENT .
The Products as
further defined in Attachment A, shall consist of:
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a)
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The
VC s5i System complying with following specifications
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Primary CPU assembly with all
acquisition, processing and I/O boards
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VH
circuitry and algorithms integrated with Primary CPU
Assembly
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Mounting bracket
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LCD
color Monitor
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Data entry devices: Keyboard, track
ball and point & click interfaces and roll-up carts if
necessary.
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Input power from 100 to 240 VAC,
50/60 Hz
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ECG
trigger card
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Digital frame grabber
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DVD
Drive
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Software package including Patient
Entry, multiple image screen formats (Ultrasound, stored and
sagittal views), Multiple Images Diameters, Automatic and manual
measurements, In line Digital, Automatic Border Detection, Nine
Minute Digital Video Storage, ChromaFlo, Lesion assessment package,
DICOM 3.0 Services, and Virtual Histology Package (herein after
referred to as “VH”)
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Software package does not include 2D
and/or 3D angio “QCA” or QCA-like software packages
(such as Paieon / IVUS software packages). GEHC may wish to offer
such software features to its End Users, prices and other
commercial terms shall be negotiated separately between the
parties, as appropriate.
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Annual software maintenance
agreements (to the exception of SW issues covered under the
Article 14 and 11) are not included in the Price of the
Products. If GEHC wishes to offer such software maintenance
agreements to its End Users, prices and other commercial shall be
negotiated separately between the parties, as
appropriate.
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Installation and Service Manuals in
English
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Packaging for Air / Road
transportation
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All
“Special” installation tools and fixtures.
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Regulatory approvals per
Section 2.1 c)
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Languages for User Manuals Graphical
User Interface messages, Safety related messages and labels per
Section 2.1 c)
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b)
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The
VC s5i/GE System based on the VC s5i as defined in Section 2.1
a) and customized for GEHC (herein after referred to as
“Customization”), including but not be limited to
optimized integration of the s5i with the GEHC Cardiovascular
system as further defined in Attachment A.
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In
order to interface the VC s5i/GE System with the GEHC
Cardiovascular system, a specific SW User Interface will be loaded
on GEHC Touchscreen-type integrated cath lab control station
Trademarked by GEHC as “Innova Central”) as further
defined in Attachment A.
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The
IVUS connectivity feature on Innova will be branded by GEHC as
“Innova IVUS”. Where applicable, a tag line
“Powered by Volcano” shall be added to clarify that
IVUS imaging will be performed by Volcano. The Innova IVUS feature
shall not be considered as part of the s5i/GE supplied by
VC.
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c)
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Regulatory Approvals, Manuals and
languages
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(i)
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Prior to Product Introduction, VC
shall obtain all applicable regulatory approvals and clearance for
the Products to be distributed by GEHC in the US and all countries
of the European Union, and provide the Products to GEHC including
the corresponding labeling in the appropriate languages:
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CE
Marking for European Union
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US
FDA Approval
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UL
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WEEE compliant
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Accompanying document for the
Products must include Operator Manuals translated in accordance
with the EU language policy of Attachment N (English, Spanish,
French, German, Portuguese, Italian, ...)
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Accompanying document for the
Products must include Installation and Service Manuals in
English
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All
Graphical User Interface messages, Safety related messages and
labels translated in accordance with the EU language policy of
Attachment N (English, Spanish, French, German, Portuguese,
Italian, ...)
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(ii)
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Prior to Product Introduction, VC
shall use commercially reasonable efforts to obtain all applicable
regulatory approvals and clearance for the Products to be
distributed by GEHC in the People Republic of China, and provide
the Products to GEHC including the corresponding labeling in
Chinese:
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CCC
Approval
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SFDA Approval
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System level name and rating plate
in Chinese, warning labels in Chinese and CCC mark shall be applied
to the Products before shipping.
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Accompanying document for the
Products must include Operator Manuals in Chinese
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Accompanying document for the
Products must include Installation and Service Manuals in
English
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(iii)
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As
soon as practical, VC shall make its best efforts to obtain
approvals and clearance to distribute the s5i in all other major
countries in the Territory such as China, major Asian countries,
ANZ, Canada and Latin America (i.e. CCC & SFDA for China, CSA
& CDMAS for Canada). When VC obtains such regulatory approvals
and clearance for its s5i system, VC shall immediately make them
available to GEHC for both the s5i and s5i/GE systems, including
Graphical User interface messages, Safety related messages, labels
and User Manuals, translated in the appropriate
language.
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(iv)
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If
GEHC identifies a business opportunity in a market or country not
initially considered by VC, the Parties should discuss and agree if
VC should proceed with the regulatory approval process and how VC
for its agents, representatives or distributors) will provide GEHC
End Users with application training and disposables.
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(v)
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When VC introduces improvements or
new features to the s5i (such as an evolution of the s5i platform
to support mechanically rotating transducer design), VC shall
immediately make such improvements available to GEHC for both the
s5i and s5i/GE systems. VC selling price to GEHC for any
improvements or new features (additional options) to the s5i will
be determined by mutual agreement between
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the
parties at the time of availability of such improvement or new
feature.
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(vi)
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GEHC will obtain the appropriate
regulatory approvals for the “Innova IVUS” as defined
in Section 2.1 b).
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(i)
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VC
and GEHC shall define and pursue jointly agreed integration and
development objectives as relates to the s5i/GE in order to
optimize the clinical efficacy and workflow combined technologies.
VC and GE HC shall [CONFIDENTIAL] their efforts on system
integration and development.
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(ii)
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VC
will define, design, specify, select components, sub-assemblies,
equipments, integrate and qualify them into a system, manufacture,
test, procure the appropriate regulatory approvals and supply the
Products to GEHC hereunder and as per the terms of this Agreement.
VC will run the engineering development programs under its quality
and regulatory framework for s5i and s5i/GE with inputs and reviews
from GEHC side. VC will provide the required information to GEHC
for the purpose of GEHC complying with its internal Product
development / introduction processes (Milestones per GEHC’s
Phase Review Discipline) and complying with applicable laws and
regulations in relation with the Products and any parts
thereof.
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(iii)
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The
Parties agree that VC shall comply with the following development
milestones:
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(iv)
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GEHC and VC will jointly define the
required performances for the Products to meet end user
expectations and tenders requirements and shall agree on a set of
minimum achievable specifications that will be translated into a
contractual “Purchase Specification” and a contractual
“Factory Acceptance Test” at the latest prior to the
Delivery of the first Pilot.
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(v)
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VC
agrees at all times to offer GEHC a competitive Product with
regards to other existing systems available on the
market.
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2.3
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Purchase and Distribution of
Products.
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(i)
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During the Term of this Agreement
and subject to Article 3, GEHC will purchase from VC, and VC
will sell to GEHC, the Products, and GEHC will distribute the
Products under VC trademarks, subject to the terms of this
Agreement. Subject to Article 3, VC shall be required to
supply the s5i/GE to GEHC exclusively, and to supply the s5i to
GEHC non-exclusively. Except for the 8 pilots as further described
in Article 5, GEHC’ commitment to purchase Products from
VC shall be limited to firm Purchase Orders released by GEHC and
accepted by VC pursuant to Article 8.
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(ii)
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Distribution will be performed by
GEHC directly or through other members of the GEHC
Group.
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2.4
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Representatives.
GEHC may appoint third
parties, including but not limited to parties that may be members
of the GEHC Group, and such as agents, distributors, brokers to
distribute, represent or promote the Products to End Users (each a
“Representative”). VC currently maintains exclusive
distribution agreements in select countries of the territory as
outlined in Attachment M, but is actively engaged in modifying said
existing agreements. GEHC’s ability to appoint third parties
is dependent upon VC’s ability to modify its existing
agreements. In priority, VC shall apply all its commercially
reasonable efforts to modify its existing agreements and give
access to GEHC in the following countries: Australia, Spain, Italy,
China, Finland, Canada and New Zealand. If VC is not able to give
GEHC distribution access to one of these country, the Parties shall
agree on the new minimum quantity for GEHC to maintain its
Exclusivity and distribution rights per Section 2.4, 3.2 and
23.3 (iii). The new minimum quantities shall reduced according to
GEHC missed market opportunity in that country.
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2.5
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Independent Contractors
. The relationship of
GEHC and VC established by this Agreement is that of independent
contractors, and nothing herein will be construed to (a) give
either Party the power to direct or control the day-to-day
activities of the other, (b) constitute the Parties as
partners, joint venturers, principal and agent, employer and
employee, co-owners, franchisor and franchisee, or otherwise as
participants in a joint undertaking, or (c) allow either Party
to create or assume any obligation on behalf of the other Party for
any purpose whatsoever. Except as otherwise set forth herein, all
financial and other obligations associated with each Party’s
business are the sole responsibility of such Party.
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3.1
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Subject to Section 3.8, during
the Term of this Agreement and subject to the Conditions below, VC
will grant non-exclusive distribution rights to GEHC for the s5i
System in the Territory.
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3.2
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So
long as GE forecasts to purchase a minimum of [CONFIDENTIAL]
units of the s5i/GE during the first 12 months post Product
Introduction (the “Exclusivity Period”), VC will grant
exclusive distribution rights to GEHC for the s5i/GE System in the
Territory during that 12 month Exclusivity Period.
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During this Exclusivity Period, VC
will not sell, lease, loan, license, transfer or otherwise provide,
or grant any distribution, or other rights to provide, directly or
indirectly, the s5i/GE to any manufacturer, distributor, customer
or other third party in the Territory, and will not pursue similar
implementations as for the s5i / GE defined herein with any of the
GEHC competitors in the Territory.
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The
Exclusivity Period shall start at the earlier of August 15,
2006 or Product Introduction, provided however that a delay in
Product Introduction is not solely caused by VC, in which case the
Exclusivity Period start date may be extended by 6 weeks, or
longer if mutually agreed by the parties. During the Exclusivity
Period, GEHC will not pursue similar implementations with any of
the VC’s competitors.
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Subject to Section 3.8, after
the Exclusivity Period and during the Term of the Agreement, GEHC
shall retain the rights to distribute the s5i/GE on a non-Exclusive
basis in the Territory.
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The
Parties may consider extending the Exclusivity Period in exchange
for certain minimum volume purchase commitments from GEHC. Similar
implementations with non-competing third parties may be pursued
with the reasonable consent of both parties.
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3.3
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Japan distribution rights for the 5i
and s5i/GE will be subject to separate negotiation and agreement,
should parties desire to pursue.
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3.4
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Exclusivity and distribution rights
shall continue in the event of any change of control of VC
ownership.
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3.5
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VC
acknowledges that at the time of signature of this Agreement, and
subject to exceptions identified in Attachment M, it does not have,
shall not maintain and shall stop any contractual obligations with
third parties which contractually put VC in breach of its
obligations in this Agreement, or contractual obligations which
refrain VC from entering into this Agreement and from appointing
GEHC as an exclusive distributor for the s5i/GE and as a
non-exclusive distributor for the s5i in the Territory as per the
terms herein.
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3.6
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VC
agrees that it will not, without the prior written consent of GEHC
in each instance: use the name, trade name, trademark, trade
device, service mark, logo, symbol or any abbreviation, contraction
or simulation thereof, owned by GEHC or by companies of the General
Electric group, in any advertising, marketing, promotional
materials, publicity, client list, press release, case studies,
references, Internet posting, or otherwise. GEHC will consult VC
prior to releasing advertising, marketing, promotional materials or
issuing a press release all using the name, trade name, trademark,
trade device, service mark, logo, symbol or any abbreviation,
contraction or simulation thereof, owned by VC.
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3.7
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During the Exclusivity Period a
defined in Section 3.2, GEHC will not distribute a competing
product to the s5i/GE (IVUS integrated with a GEHC Innova System).
Subject to Section 23.3 (iii), GEHC obligation not to
distribute a competing product to the s5i/GE (IVUS integrated with
a GEHC Innova System) will not apply in the event (i) where a
company of GEHC Group acquires a company or part thereof already
offering such a product or when (ii) GEHC exceptionally
resells a competing product as requested by one of its End User. In
the event GEHC Group acquires a company or part thereof already
offering such a product, the Exclusivity Period shall terminate
immediately.
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3.8
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VC
shall retain the right to market and distribute products similar to
the s5i in all the countries and territories in the world.
Notwithstanding anything to the contrary herein contained, VC shall
not have the right to distribute products in the Territory
containing key features or attributes considered as part of the
Product’s Customization for GEHC, specifically optimized
integration of the s5i with the GEHC Cardiovascular system and the
SW User IF on a GEHC Touchscreen-type integrated cath lab control
station Trademarked by GEHC as “Innova Central”), GEHC
trade name, trademark, logo, color theme, user
interfaces.
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ARTICLE 4.
RESPONSIBILITIES OF THE PARTIES
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4.1.
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VC responsibilities
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Throughout the duration of this
Agreement, and notwithstanding anything herein contained, VC shall
be responsible and bear the corresponding costs for:
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Defining, Specifying, Designing or
Selecting components, integrating, qualifying them into a system,
Manufacturing, Validating, Verifying, testing and packing the s5i
and the s5i/GE for GEHC
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Developing s5i and s5i/GE under
VC’s quality and regulatory framework with appropriate input
from GEHC
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Supporting GEHC in the integration
of the s5i/GE and s5i with the GEHC Cardiovascular
systems
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Subject to Section 2.1 c),
obtaining all the appropriate regulatory approvals for GEHC to sell
the s5i and the s5i/GE in all major markets of the world and lesser
markets where practicable (excluding Japan)
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Supplying the s5i and the s5i/GE to
GEHC
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Subject to Section 2.1 c),
obtaining and maintaining the required Product certifications for
GEHC to distribute them in the Territory, i.e. including but not
limited to, USA, Europe, Canada, Latin America, China,
e.g.:
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o CE Marking
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o US FDA
Approval
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o UL/CSA
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o CMDCAS
(Canada)
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o SDA (China)
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o CCC(China)
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•
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Developing unpacking, installation,
preventive maintenance, troubleshooting and service procedures,
spare parts lists and providing the associated documentation with
each Product and part and sub-assemblies, equipment thereof, such
as but not limited to Pre installation Manual, Service Manuals in
the English language.
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•
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Subject to Section 2.1 c),
Developing, translating and implementing End user interfaces
messages
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•
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Subject to Section 2.1 c),
developing, translating and providing the End-Users Operator
Manuals with each Product in the following languages:
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o English
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o German
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o French
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o Spanish
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o Portuguese
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o Italian
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o Chinese
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•
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Performing the end user application
training for the s5i and the s5i/GE sold by GEHC within reason and
per standard industry practice
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•
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Defining and providing GEHC
personnel with the appropriate Installation and Service Training
(Train the Trainer) in accordance with Article 10.
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•
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Assisting GEHC in collecting
feedbacks from End-Users and service personnel upon installation of
the Pilots installed and implementing corrective / improvement
actions on subsequent Products to be delivered.
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•
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Providing information to GEHC for
the purpose of GEHC’ complying with its internal Product
development / introduction processes and complying with applicable
laws and regulations in relation with the Products and any parts
thereof.
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•
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Providing information and supporting
GEHC in the commercial promotion of the Products in the
Territory.
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11/39
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•
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Throughout the duration of the
Agreement and for a period of 10 years following the last
manufacturing date of the Product, performing the second level of
technical support to GEHC and handling, solving and closing field
complaints related to the Products:
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o PQRs: Significant
quality or technical issue
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o CSOs: Customer
Satisfaction issues
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o PSRs: Safety
issues
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•
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Throughout the duration of the
Agreement providing GEHC with Products spare parts for
10 years following the last manufacturing date of the Product
in accordance with Article 11.
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•
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Throughout the duration of the
Agreement and for a period of 10 years following the last
manufacturing date of the Product and in case of product recall,
safety, regulatory or severe performance issue, VC shall be
responsible for defining, designing, manufacturing and supplying to
GEHC Field Modification Instructions kits (“FMI”) for
the purpose of remedying to such issues. VC shall supply such
upgrade kits (including but not limited to Hardware, Software,
instructions, packaging, tooling, ....) at no charge to GEHC for
deployment on the impacted Products and participate to 50% of GEHC
on-site direct labor cost (based on USD 93 / hour and the standard
intervention time defined per the Field Modification Instruction,
excluding travel and living that shall be bore by GEHC)
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•
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Supplying the Products and spare
parts ordered by GEHC in the quantities and at the times specified
by GEHC in its Purchase Orders in accordance with the terms and
conditions of its Purchase Orders and this Agreement, assuming that
GEHC’s order is within its forecasted range as outlined in
Article 6
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4.2.
|
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GEHC responsibilities
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Throughout the duration of this
Agreement, and notwithstanding anything herein contained, GEHC
shall be responsible and bear the corresponding costs
for:
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•
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Providing specified assistance to VC
during the initial development phase of the Product with a view
that the Product receives broad market acceptance and meet End-User
expectations and support VC with the integration of the s5i/GE with
the GEHC Cardiovascular systems
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•
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Providing VC with some specified
training on certain GEHC’ applicable processes (Sourcing,
Service, Support, etc)
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•
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Participating in design reviews
specifically of s5i/GE as and when requested by VC
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•
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Offer the s5i and the s5i/GE as part
of its Cardiovascular and Interventional Radiology product
lines
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•
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Laying out system processes such
that the s5i or s5i/GE are included as an option directly on all
initial Cardiovascular and Interventional Radiology systems quotes
after Product Introduction and provided regulatory approvals are in
place.
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•
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Shipping and Installing and
Servicing the Products sold by GEHC in accordance with VC’s
instructions.
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•
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Coordinate application training with
VC personnel for the s5i and s5i/GE systems sold by GEHC
|
12/39
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•
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Offer ongoing service under a GEHC
service contract for the s5i and s5i/GE systems sold by
GEHC.
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•
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Providing its expertise and support
to VC in relation with certification in countries requiring a local
representative (FDA 510K, MHW, SDA).
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•
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Obtaining the appropriate regulatory
approvals for the “Innova IVUS” SW feature as defined
in Section 2.1 b).
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•
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Loading the “Innova
IVUS” SW feature onto the CardioVascular systems to be
interfaced with the s5i/GE.
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•
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Providing support to VC in its
negotiation with its key suppliers for the purpose of reducing
costs and selling Prices to GEHC as well as improving suppliers
lead-times and payment terms.
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•
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Validating the Service and Operator
Manuals satisfactorily drafted by VC.
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•
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Collecting End-User and service
feedbacks from the Pilot sites and communicating them to
VC.
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•
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Defining and developing collaterals
to promote the Products, including brochures, datasheets, trade
shows.
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•
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Providing training to its own
GEHC’ designated Sale, Service personnel subject to
Article 10
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•
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Communicating to VC all field
complaints related to the Products and allowing VC to have direct
access to GEHC customers, personal or representatives for the sole
purpose of solving such complaints.
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|
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|
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|
•
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Regularly providing VC with market
feedbacks on Products specifications and performances for the
purpose of improving the Products competitiveness.
|
|
5.1
|
|
Subject to the term of this
Agreement including Product Definition Section 2.1 and
pursuant to the Purchase Orders for Pilots attached in Attachment
J, GEHC is willing to purchase and take delivery from VC of a total
quantity of 8 pilot “Products”, (collectively
referenced herein as “Pilots”). The period starting
from delivery of the first Pilot to the delivery of the last one is
defined as the “Pilot Phase”.
|
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It
is agreed that certain features of the Products or certain
components of the software package, including but not limited to
Virtual Histology, may not be available at Pilot phase or at
Product Introduction as further described in Section 2.2. The
parties agree that Pilots that are sold prior to fully meeting the
Product Definition per Section 2.1, will be upgraded by
Volcano as soon as practicable, at no cost to GEHC or the
end-user.
|
|
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|
|
5.2
|
|
The
purpose of GEHC installing the Pilots at End-Users sites will be to
ensure that:
|
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|
•
|
|
The
Products meet or exceed End-User expectations,
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|
•
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The
Products can be easily installed and serviced by GEHC,
|
|
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|
|
•
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The
GEHC Service, GEHC On Line Centers personal are satisfactorily
trained,
|
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|
|
•
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|
The
Product Service documentation and Operator documents are available
and of good quality.
|
13/39
|
|
•
|
|
The
processes between GEHC and VC are in place before entering in full
production (Logistics — shipping, PQRs — CSOs —
PSRs handling, spare parts ordering).
|
GEHC and VC
will collect feedbacks from such Pilot sites, identify potential
issues that occurred during the Pilot Phase, and agree on a
corrective action plan. Once all risks are identified and reduced
to a level acceptable to both Parties, and once all issues are
fixed and processes stabilized, GEHC and VC will freeze the Product
definition, update and agree in writing on the Purchase
Specifications and on the final Factory Acceptance Test to be
attached as Attachment B hereto and made an integral part of this
Agreement. The Parties will then enter in full Production Phase as
described in Article 6 below.
|
5.3
|
|
The
VC selling price to GEHC for the 8 above-mentioned Pilots is
subject the conditions of Article 7. All invoices will be
settled according to the terms defined in Article 13. For
these 8 pilots, VC should provide upgrades kits to Full Production
level (as defined in section 2.1) at no cost to GEHC, GEHC covering
the logistics and labor costs.
|
|
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|
|
|
5.4
|
|
Subject to the final approval of
milestones identified in Article 2.2(iii), these 8 Pilots
should start with 4 external evaluation units as soon as possible
to be delivered by VC not later than May 1, 2006. These 4
external evaluation Pilots shall be installed and supported jointly
by VC and GEHC engineering group, until such Pilots have been
updated to the level of production units. GEHC shall have, at its
discretion, the ability to order any combination of s5i and s5i/GE
Products for the Pilot Phase such that the total of units ordered
does not exceed 8 units. VC agrees to upgrade any Pilot units, at
GEHC’s discretion, to s5i/GE units at no cost to GEHC, with
GEHC covering the logistics and labor costs.
|
|
|
|
|
|
|
|
In
addition to the above-mentioned quantity, the number of Pilots may
be extended by a mutually defined amount to seek broader customer
feedback from varying market segments of interventional radiology
and interventional cardiology. For such additional Pilots, VC shall
provide upgrades kits to Full Production level (as defined in
Section 2.1) at no cost to GEHC, GEHC covering the logistics
and labor costs.
|
|
|
|
|
|
5.5
|
|
Notwithstanding anything to the
contrary herein contained, GEHC will not be obliged to take
Delivery of any Pilots or Products unless:
|
|
|
•
|
|
The
Product is in full compliance with the Purchase Specification and
passes the Factory Acceptance Test as defined in Section 2.2
(iii), and
|
|
|
|
|
|
|
|
•
|
|
For
any Product to be sold in Europe, the Product is CE Marked
approved, and
|
|
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|
|
|
|
|
•
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|
For
any Product to be sold in the US, the Product is UL and FDA 510K
approved, and
|
|
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|
|
|
|
|
•
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|
For
any Product to be sold in China, the Product is CCC and, SDA
approved, and
|
|
|
|
|
|
|
|
•
|
|
For
any Product to be sold in Canada, the Product is CSA and CMDCAS
approved, and
|
|
|
|
|
|
|
|
•
|
|
The
Product is not under a recall as reported to a national
authority.
|
14/39
If during the
Pilot Phase and subject to Section 2.1 c), VC has not obtained
regulatory approvals or clearance for a Pilot in a given country,
the Parties shall reallocate the destination of the Pilot to an
other country.
ARTICLE 6.
PRODUCTION PHASE OF THE PRODUCTS
|
6.1
|
|
The
Parties agree that this Agreement will enter into the
“Production Phase”, when GEHC estimates that sufficient
feedbacks have been collected during the Pilot Phase, that the
Product meets End User expectations, that all risks identified are
retired, and that all issues are fixed and processes stabilized.
GEHC and VC shall therefore agree in writing on an updated and
fixed Purchase Specification and to a Factory Acceptance Test in
order to reflect the required changes identified during the Pilot
Phase. The Parties will work to finalize such Purchase
Specification and Factory Acceptance Test at the latest
30 days after the Delivery of the last Pilot. Should the
Parties fail to agree on the same by this date, GEHC will have the
right to terminate this Agreement with a thirty days prior written
notice, without any liability whatsoever. After agreement on the
Purchase Specification and Factory Acceptance Test, such documents
will be considered as Attachment B and an integral part of this
Agreement and GEHC will then release forecasts and Purchase Orders
to VC subject to the following provisions:
|
|
|
|
|
|
6.2.
|
|
Estimated volume.
Subject to
Section 6.3 below, GEHC’ anticipated volume at the
signature date of this Agreement is estimated to be
[CONFIDENTIAL] to [CONFIDENTIAL] Products during year
2006, and [CONFIDENTIAL] to [CONFIDENTIAL] units
during year 2007. Despite the indicative nature of such estimate,
VC represents and warrants herein that it has the capacity and
expertise necessary to manufacture and deliver to GEHC the
presently estimated volume of Products, and any increase up to
20 percent of such volume.
|
|
|
|
|
|
6.3.
|
|
Forecast . Notwithstanding anything to the
contrary herein contained including Section 6.5, any forecast
of GEHC’ requirements for Products shall not be binding in
any way on GEHC. Any such forecast may be modified at any time by
GEHC in its sole discretion.
|
|
|
|
|
|
6.4.
|
|
Commitment . During the production phase,
GEHC’ commitment to purchase Products from VC shall be
limited to firm Purchase Orders released by GEHC and accepted by VC
pursuant to Article 8. Unless agreed otherwise in writing by
the Parties, VC will not manufacture or assemble any Products, nor
procure required materials except pursuant to accepted Purchase
Orders or the provisions of Section 6.5. Unless agreed
otherwise in writing by the Parties, GEHC shall not be responsible
or in any way liable to VC or any third party with respect to any
material commitments or production arrangements in excess of the
amounts defined in Section 6.5.
|
|
|
|
|
|
6.5.
|
|
GEHC forecasts and orders to VC will
consist of:
|
|
|
•
|
|
“Medium Term” forecasts,
updated twice a year (Week 10 and Week 37) covering the second half
of the current year and the first half of the following
year
|
|
|
|
|
|
|
|
•
|
|
“Short Term” forecasts
updated monthly and giving visibility of the current Quarter and
the next Quarter.
|
15/39
|
|
•
|
|
Individual Purchase Orders to be
communicated by GEHC to VC at least two weeks prior to Delivery.
GEHC shall use its best efforts to communicate the Individual
Purchase Orders as soon as reasonably possible, to allow VC to
better plan its production.
|
The Medium Term
Forecast would allow VC to plan its own supply of components parts
and its manufacturing schedule and capacity.
The Short Term
Forecast shall allow VC to order long lead time components parts
required to satisfy GEHC forecasted needs to be confirmed through
Individual Purchase Orders. VC shall be able to satisfy any
incremental GEHC demand not exceeding 20% of the forecasted
volume.
VC shall be
able to deliver in a timely manner any Purchase Orders released at
least two weeks prior to Delivery and in accordance with
GEHC’ Short Term forecasts. Unless agreed upon by VC, GEHC
requested Deliveries per Individual Purchase Orders for a given
week shall not exceed 200% of the average weekly production per the
Short Term Forecast.
|
6.6.
|
|
Any
failure by VC to deliver the Purchase Orders in accordance with the
dates set forth in GEHC Purchase Orders and acknowledged by VC in
accordance with Section 8.2, will subject VC to the provisions
set forth in Section 15.3.
|
ARTICLE 7.
PRICES AND IMAGE CO-REGlSTRATION SERVICES
|
7.1
|
|
Pricing . VC selling price to GEHC for the
s5i and s5i/GE Products shall be Ex-works Rancho Cordova, CA, USA
(the “Prices’’). Prices shall include all
packaging, date of manufacture and bar code labeling which GEHC may
request from time to time. In no event shall the Prices be
increased by VC throughout the duration of this
Agreement.
|
|
|
|
|
|
|
|
All
prices referred to in this Agreement will be quoted in USD unless
agreed otherwise in writing by the Parties.
|
|
|
|
|
|
|
|
Prices shall correspond to
configurations of the s5i and s5i/GE allowing basic operation of
the systems without the need for additional accessories. The
Product shall consist of elements as defined in section 2.1.
Selling prices for additional accessory parts (for more elaborate
configurations) shall be agreed upon prior to Product
Introduction.
|
|
|
|
|
|
|
|
Per
the schedule below, the Prices shall be based on the actual volume
of s5i and s5i/GE units (taken together) purchased by GEHC during a
Calendar Year:
|
|
|
|
|
|
|
|
|
|
Number of
Products
|
|
Price per
unit
|
|
|
|
s5i and s5i/GE
units taken together
|
|
s5i/GE or
s5i
|
|
|
|
purchased by
GEHC during a Calendar Year.
|
|
|
|
|
|
|
|
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|
|
|
[CONFIDENTIAL] to [CONFIDENTIAL] units
|
|
$
[CONFIDENTIAL]
|
16/39
|
|
|
|
|
|
|
|
|
[CONFIDENTIAL] to [CONFIDENTIAL] units
|
|
$
[CONFIDENTIAL]
|
|
|
|
[CONFIDENTIAL] units and more
|
|
$
[CONFIDENTIAL]
|
|
7.2
|
|
Mid Year and Year End
Reconciliation. At the beginning of the Year, GEHC
may decide to purchase the Products at a pre-discounted price (ie.
$ [CONFIDENTIAL] or $ [CONFIDENTIAL] per
unit).
|
|
|
|
|
|
|
|
At
the end of the calendar year, and based on the actual volume of
Products purchased by GEHC either a balance rebate will be issued
by VC to GEHC or a refund will be issued by GEHC to VC.
|
|
|
|
|
|
|
|
In
order to minimize the Year End balance amount due by one Party to
the other Party, the Parties may decide to perform a Mid Year
Reconciliation and adjust the prices for the remaining of the
calendar year accordingly.
|
|
|
|
|
|
|
|
For
the remaining of the calendar year following the Product
Introduction, minimum quantities required for GEHC to be qualified
for discounted Price shall be Prorata temporis to the remaining of
the calendar year. For the avoidance of doubt, if Product
Introduction occurs on April 30th, 2006, the price of $
[CONFIDENTIAL] / unit should be effective if GEHC orders at
least 2/3 of [CONFIDENTIAL] units = [CONFIDENTIAL]
Product during the remaining of 2006, and the Price of $
[CONFIDENTIAL] / unit should be effective if GEHC orders at
least 2/3 of [CONFIDENTIAL] units = [CONFIDENTIAL]
Product during the remaining of 2006. External Evaluation units and
Pilots ordered by GEHC, whether shipped before or after the Product
Introduction shall be included in the overall GEHC
volume.
|
|
|
|
|
|
7.3
|
|
Image Co-Registration
Service.
|
|
|
|
|
|
|
|
The
[CONFIDENTIAL] of the Innova Fluoro Images and the IVUS
images will significantly increase the clinical value of the IVUS
[CONFIDENTIAL] to the End User, thus could represent a
higher value proposition for VC’s IVUS Catheters offering,
driving usage and/or catheters pricing.
|
|
|
|
|
|
|
|
[CONFIDENTIAL]
VC agrees to buy
[CONFIDENTIAL] from GEHC as follows:
|
|
|
|
|
|
|
|
|
|
o
|
|
From the date
of Products installation until the [CONFIDENTIAL] month
anniversary of such Installation, VC shall purchase from GEHC
[CONFIDENTIAL] for each [CONFIDENTIAL] s5i/GE or s5i
units sold by GEHC (directly through GEHC or indirectly through
GEHC agents, distributors and representatives)
|
|
|
|
|
|
|
|
|
|
o
|
|
Passing the
[CONFIDENTIAL] month anniversary of a s5i/GE or s5i
installation, GEHC agrees to provide [CONFIDENTIAL] to VC
for [CONFIDENTIAL] .
|
|
|
|
|
|
|
|
|
|
o
|
|
For the purpose
of establishing the number of [CONFIDENTIAL] to be purchased
by VC, VC shall be responsible for consolidating the number of
[CONFIDENTIAL] by Country, Region and provide a quarterly
reporting to GEHC. VC may also use the number of
[CONFIDENTIAL] .
|
17/39
|
|
|
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|
|
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|
|
|
|
|
|
o
|
|
Quarterly, VC
shall pay GEHC for the corresponding number of
[CONFIDENTIAL] .
|
|
|
|
|
|
|
|
|
|
o
|
|
In countries
where VC founds it impractical to manually consolidate the
[CONFIDENTIAL] . VC shall establish a report based on
[CONFIDENTIAL] .
|
|
|
|
|
|
|
|
|
|
o
|
|
For the purpose
of consolidating the [CONFIDENTIAL] .
|
|
|
|
|
|
|
|
|
|
o
|
|
GEHC shall have
the right to audit [CONFIDENTIAL] . For countries where such
[CONFIDENTIAL] does not exist, GEHC shall have the audit
rights over VC records relating to the calculation of the
[CONFIDENTIAL] .
|
|
|
|
|
|
|
|
|
|
o
|
|
Parties
acknowledge that all of the s5i and s5i/GE systems contemplated in
this agreement are to be completed as [CONFIDENTIAL] . Units
placed on “ [CONFIDENTIAL] ” or “
[CONFIDENTIAL] ” shall not be allowed as part of this
formal agreement. In situations where a customer insists on a
[CONFIDENTIAL] agreement for the s5i/GE (not an s5i)
configuration in a GE cath lab, VC and GEHC may mutually agree to
offer a [CONFIDENTIAL] agreement (under a VC catalogue
number, not a GEHC catalogue number). In this case, VC will have
all responsibility for the sales process and system installation,
warranty and start-up (which may be subcontracted to GE) and a
fixed, on-time, unlimited [CONFIDENTIAL] would be paid to
GEHC as follows: $ [CONFIDENTIAL] . at time of installation
and $ [CONFIDENTIAL] 12 months following installation
(due on s5i/GE only). Note that since the s5i/GE would be delivered
under a VC catalogue number, no [CONFIDENTIAL] would be due
to GEHC on future [CONFIDENTIAL] .
|
|
7.4
|
|
Software/Firmware
. The Price of all
Pilots and Products include a perpetual, paid- up, worldwide,
irrevocable license for GEHC, GEHC Group, its End-Users, its
customers, Representatives to use in the operation, maintenance and
repair of the Products any related software/firmware which is
furnished to GEHC, GEHC Group, its End-Users, Representatives or
other users of GEHC products containing the Products.
|
|
|
|
|
|
7.5
|
|
Cost Reductions
. During the Term of the
Agreement, GEHC and VC shall undertake a program to achieve
reductions in the cost of Products by utilizing cost-effective
design, lower cost components, new technology, alternative sources,
specification or features trade-off, productivity improvements and
automation of the manufacturing process. To assist each other in
this joint program, GEHC and VC shall determine the feasibility and
potential savings from alternative actions, and shall share (as
necessary) the required cost data, expertise in selecting
materials, components, alternative sources and manufacturing
processes for analysis. VC and GEHC shall use their commercially
reasonable efforts in this joint cost reduction
|
18/39
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program to further reduce the Prices
by at least [CONFIDENTIAL] a year without altering VC
margin. Any saving resulting from any cost reduction program
specifically enabled by virtue of GEHC’s purchasing power,
buying agreements, partnerships with other common vendor, etc..
will result into a [CONFIDENTIAL] allocation of the savings
to VC, and a [CONFIDENTIAL] allocation of the savings to
GEHC in the form of a reduction of the Prices given in Section
7.1 . . Furthermore, any saving resulting
from any cost reduction program identified and pursued by VC alone
or by collaboration between VC and GEHC that also results in
material changes affecting fit / function / form, Service,
Reliability, Functionality of the Product which, in turn, force
GEHC to dedicate resources to re-qualify the Product and/or its
spare parts and/or re-train field service personnel will result
into a [CONFIDENTIAL] allocation of the savings to VC, and a
[CONFIDENTIAL] allocation of the savings to GEHC in the form
of a reduction of the Prices given in Section 7.1. Such
[CONFIDENTIAL] allocation to GEHC is intended as
consideration / reimbursement for required dedication of resources
to adapt to product changes. For the avoidance of doubt, any cost
reduction which is pursued by VC alone or together with GEHC that
does not affect fit / function / form, Service, Reliability,
Functionality and does not require re-qualification of the Product
or changes in spare parts or field service training by GEHC would
result in [CONFIDENTIAL] of the cost savings being allocated
to VC.
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ARTICLE 8.
PURCHASE ORDER RELEASES
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8.1.
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Contents . A purchase order released by GEHC
for Products or spare parts (“Purchase Orders”) may
consist of a hard copy in the form set forth in Attachment F, an
electronic message or other written communication from GEHC to VC,
which complies with the requirements of this Agreement. Purchase
Orders released by GEHC are subject to the terms and conditions of
this Agreement and are considered an integrate part thereof, and
shall identify the delivery date or dates and the quantities to be
released for Delivery within the lead times specified in
Article 6 or in Attachment D. REGARDLESS OF FORM, EVERY
PURCHASE ORDER IS DEEMED TO INCLUDE GEHC’ STANDARD TERMS AND
CONDITIONS OF PURCHASE SET FORTH IN ATTACHMENT F.
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Notwithstanding anything else to the
contrary in this Agreement, if a Purchase Order released by GEHC
already contains or refers to Standard Terms and Conditions of
Purchase, such Standard Terms and Conditions of Purchase shall
prevail over Attachment F.
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8.2.
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Acceptance . Within 2 business days from
receipt of a Purchase Order, VC shall acknowledge receipt of such
Order by ensuring it has the necessary stock of component parts for
its own production, and confirming by any mean defined by GEHC, the
delivery date and quantity for the ordered items. VC may not reject
any Purchase Order of GEHC unless, in accepting a Purchase Order,
VC would violate any law or regulatory body
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8.3.
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Changes .
Subject to Article 6, GEHC may change the quantities,
configurations, and delivery dates on individual Purchase Orders
for Products without penalty as long as GEHC notifies VC of the
changes at least two weeks prior to Delivery.
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19/39
VC shall agree
upon any GEHC request for change in quantities, configurations, and
delivery dates on individual Purchase Orders for Products occurring
less than two weeks prior to Delivery.
GEHC may change
the quantities and delivery dates on Purchase Orders for Spare part
without penalty as long as GEHC notifies VC of the changes not
later than the leadtimes specified in Attachment D.
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9.1.
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Customer Copies
. Unless agreed
otherwise in writing by GEHC, each Product delivered by VC shall
include a Pre-installation Manuel in English, a set of Operator
Manuals in English, French, German, Spanish and any additional
language as defined in Article 4, a set of Service Manuals in
English, containing all applicable drawings, schematics, software
license(s), software documentation, spare part lists, theory of
operation, service troubleshooting diagnostics, and instructions
necessary for the installation, operation, maintenance and repair
of the Product. The documentation shall be in a format acceptable
to GEHC.
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9.2.
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GEHC Master Copy
. VC shall provide to
GEHC at no additional charge a complete set of reproducible master
copies of all documentation listed above, which GEHC may reproduce
without charge. If any change in the Product requires a change in
the documentation, VC shall promptly notify GEHC of the change and
provide a revised reproducible master copy without
charge.
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10.1
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VC
shall provide any necessary personnel and equipment to train
GEHC’ employees, Representatives with respect to the
installation, operation, maintenance and repair of the Products.
Such training shall be at VC’s facility and be provided at no
cost to GEHC, for a maximum of 10 persons at a time and for maximum
of 6 sessions a year.
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10.2
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VC
shall not pay for travel and living expenses incurred by GEHC
employees, and those of its Representatives. If VC provides
training at GEHC’ designated location (other than VC’s
facility), GEHC shall reimburse VC for the reasonable travel and
living expenses incurred by VC’s personnel to conduct such
training at such location; provided , however, that
such reimbursement shall be limited to the amount estimated by VC,
and approved by GEHC in advance.
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ARTICLE 11.
SPARE PARTS, SERVICE CAPABILITY AND SUPPORT
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11.1.
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Testing . VC shall test all repaired
Products and spare parts using the highest quality test plan or
procedure used by VC to test products similar to the
Products.
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11.2.
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Duration . For 10 (ten) years after the
last manufacturing date of the Product, VC shall maintain the
capability of repairing Products (including the know-how to repair
spare parts and qualified employees) and/or of furnishing
replacement products, and of furnishing all spare parts, service
tools, documentation and instruments necessary to effectively
service the Product(s). As rapid technology evolution may make
maintaining 10 years of spare parts impossible, VC agrees to supply
either complete sub-assemblies or new units that are functionally
equivalent, where appropriate.
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11.3.
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If
a spare part becomes obsolete impeding VC from supplying such spare
part to GEHC for the remaining of the 10 years period as
defined in Section 11.2, VC is committed, in the order of
priority to (i) inform GEHC by written notice with
acknowledgement of receipt the obsolescence of such Spare part
which shall not be earlier than 6 months from such notice,
(ii) propose to GEHC a replacing product fully compatible
(regarding fit, form and function) with the Spare part concerned
(iii) propose to GEHC the name of another supplier having the
ability and the desire to manufacture the Spare part concerned if
possible, or (iv) propose to GEHC a last buy which conditions
(price, delivery date, etc.) will have to be agreed by both
Parties, and (v) to promptly transfer to GEHC all instruments,
tools and documentation necessary to service such spare
part(s).
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11.4.
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Emergency: In case of emergency (e.g.. if GEHC
does not have any more spare parts available), VC shall make it
commercially reasonable efforts to deliver any Spare part for the
Product within 24 hours of GEHC’ request and send it to the
location designated by GEHC.
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11.5.
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Spare parts Pricing.
Spare parts list,
corresponding pricing, lead-time and reparability should be agreed
upon between GEHC and VC prior to entering in the Full Production
Phase. Such list and pricing shall be listed in Attachment D.
Prices for spare parts should be defined in such a way that the
total Prices of all spare parts necessary to build one Product
should not exceed USD [CONFIDENTIAL] .
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11.6.
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VC
shall repair any spare part returned by GEHC within one
(1) week from reception date.
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11.7.
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Field related complaints.
Throughout the duration
of this Agreement and for ten years following the last
manufacturing date of the Product, VC shall perform the second
level of support to GEHC and handle field related complaints
(recurrent technical issues, technical related Customer complaints,
product safety issues) related to the Products. This activity will
consist into analyzing, developing and implementing technical fixes
and closing field complaints related to the Product as communicated
by GEHC to VC:
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PQRs: Significant Quality or
technical issues:
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VC shall complete the assessment within 5 Days from
notification
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VC shall do its commercially reasonable effort to implement a fix
within 30 Days from notification
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CSOs: Customer Satisfaction
Issue
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VC shall complete the assessment within 5 Days from
notification
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21/39
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VC shall do its commercially reasonable effort to implement a fix
within 30 Days from notification
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shall complete the assessment within 2 Days from
notification
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VC shall do its commercially reasonable effort to implement a fix
within 30 Days from notification
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Detailed
processes between GEHC and VC related to field related complaints
should be implemented prior to the Full Production
Phase.
GEHC shall
manage the relationship with its End Users, and shall implement the
fixes proposed by VC. Nevertheless, if required and deemed
necessary by the Parties, VC shall dispatch its personnel at a GEHC
End User site for the purpose of diagnosing and fixing a specially
severe or difficult issue that cannot be solved by GEHC using
reasonable means.
ARTICLE 12.
OTHER COMMERCIAL TERMS
Products shall
be delivered Ex-works Rancho Cordova, CA, USA, including packaging
for air/road transportation and labeling according to GEHC
requirements.
Provisions
concerning transfer of title and other commercial terms which are
not specifically stipulated in the articles of this Agreement are
contained in GEHC’ Standard Terms and Conditions of Purchase
set forth in Attachment F.
GEHC shall
cover the cost of shipment from GEHC warehouse, installation,
warranty, commission for GEHC Sales team and other distribution
costs. Subject to the terms of Article 4, VC shall provide
Product Specialist and sales tools support to GEHC transactions.
GEHC shall have access to the content of VC sales tools, but VC
shall not be obligated to provide GEHC with printed
materials.
GEHC shall
feature the s5i/GE in its booth and advertise as appropriate at
agreed upon symposia and tradeshows. VC shall be able to feature
s5i and the s5i/GE in their exhibitions and symposia as
well.
Systems sold by
GEHC shall retain the Volcano name. GEHC and VC will agree upon a
trademarked name for the s5i/GE. The SW feature to be loaded by
GEHC onto the GEHC “Innova Central” Touchscreen”
will be branded by GEHC as “Innova IVUS”.
VC shall be
responsible for ongoing disposable and software upgrade
transactions and logistics per normal business practices (VC will
bare the cost of and receive the revenue for any and all
disposables and software and hardware upgrades once a unit is
placed by GEHC).
ARTICLE 13.
INVOICES-PAYMENT
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13.1
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Content of Invoice
. VC’s invoices
shall contain the Purchase Order release number, item number on
such release, gehc
part number, invoice quantity, unit of measure, unit price, total
invoice amount, (excluding VAT), VAT amount, total invoice amount
(including VAT), VAT registration number, name of VC, phone number,
address to which remittance should be sent, and such other
information as may be required by GEHC.
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13.2
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Payment by GEHC
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Subject to Article 5 and 6,
during the Production Phase, GEHC shall settle the invoice within
[CONFIDENTIAL] days from invoice date after receiving both
the orders items and an invoice prepared in accordance with the
terms of this Agreement.
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13.3
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Payment by VC of GEHC’s Image
Co-Registration Services .
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Subject to Section 7.3, VC
shall settle the payment of Image Co-Registration Services due to
GEHC within [CONFIDENTIAL] days following close of Quarter.
Payments shall be made to:
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General Electric Company
GE Healthcare Technology
Interventional Cardiology and Surgery Business
3000 N Grandview Blvd
Waukesha 53188
Wisconsin, USA
ARTICLE 14.
WARRANTY-REPAIR
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14.1.
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Terms . VC warrants that the Products to
be delivered under the Agreement will be free from defects in
material, manufacturing workmanship, and title. Product warranties
and all remedies for warranty failures are granted for a period of
eighteen (18) months from Product delivery date or twelve
(12) months from Product installation date, Which ever occurs
the first. Any goods or parts furnished to GEHC during the warranty
period of a Product to correct a warranty failure in the said
Product shall be warranted for an additional eighteen (18) month
period from parts delivery or three (3) months from part
installation date, which ever occurs the first.
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14.2
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Return of Non-conforming or
Defective part of a Product .
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GEHC may return any non-conforming
or defective part of a Product under warranty to VC with VC prior
authorization. In such case, any such part of a Product shall be
returned to VC’s facility or authorized service center, with
all transportation charges paid by VC and the risk of loss passing
to VC when the part of the Product is delivered to the carrier of
VC’ choice. If GEHC elect to return any non-conforming or
defective part of a Product under warranty to VC without VC prior
authorization, transportation charges shall be paid by GEHC and the
risk of loss passing to VC when the part of the Product is
delivered to VC.
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14.3.
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Repairs / Replacement /
Credit . If
any Product or part thereof is found to be defective or
non-conforming during the warranty period (Defective Part), VC
shall within five (5) working days from the date of reception
of the Defective Part in its premises unless a longer period is
mutually agreed upon, repair or replace the Defective Part. The
list of repairable Parts shall be agreed upon between the
Parties.
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23/39
The Parts that
will be defined as VC only shall not repair returnable for GEHC. To
the extent that a Defective Part of a Product under warranty is not
promptly repaired or replaced by VC within five (5) working
days from receipt of the part by VC, VC shall promptly refund or
credit GEHC with a payment corresponding to the selling Price of
the part to GEHC and GEHC may elect to take such credit on any open
invoices of VC.
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14.4
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Trouble Shooting Report
. For any claim under
warranty and for all repairable parts (as defined in Attachment D),
GEHC shall attach a troubleshooting report detailing the findings,
Product history (Serial number and installation date of the
Product, Serial Number of the Defective Part) and all information
required to define if the warranty was still applicable when the
failure occurred. As part of the program, a troubleshooting report
template will be developed and agreed upon by GEHC and VC. It shall
include the proper warranty conditions allowing GEHC Field Engineer
to only return spare parts under warranty. A blank template of this
troubleshooting report shall be included with all returnable (all
parts with a unit price higher than $500) or repairable spare parts
as defined in Attachment D supplied by VC to GEHC. Spare Parts
shall be labeled with the appropriate level of information
(Manufacturing date or Serial Number) to allow GEHC or VC to
establish if a defective part is still under warranty.
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14.5
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Emergency: In case of emergency and upon GEHC
notification, VC shall be able to ship at GEHC designated location,
a replacement for a non-conforming or Defective Part of a Product
under warranty. If the corresponding non-conforming or Defective
Part has not been returned by GEHC to VC within thirty
(30) days from GEHC’ notification, VC shall be allowed
to invoice GEHC for the Price of such part.
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14.6
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All
repaired of replaced spare parts to be sent to GEHC, should be
processed in accordance with Attachment H.
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ARTICLE 15.
PERFORMANCE MEASUREMENTS
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15.1.
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Product Quality
. VC is committed to
quality in the performance of this Agreement, and acknowledges that
the delivery of quality Products is of the essence to this
Agreement. All Products and spare parts shall be manufactured in
accordance with the following principles:
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The
quality goal for all Products at the time of installation at an
End-User location is zero “Failure On Installation”
Product (“FOl”). A FOI Product is a Product that fails
(does not meet the Purchase Specifications) within one week of turn
over of the Product to an End-User.
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The
quality goal for all spare parts at the time of a service
intervention at an End-User location is zero “Failure On
Arrival” Spare part (“FOA”). A FOA Spare part is
a Spare part that fails within one week from service
intervention.
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24/39
For any FOA or
FOI, VC shall promptly submit to GEHC a written corrective action
plan which at a minimum contains an analysis of the first root
cause(s) and specific actions taken or planned to correct the
problem.
If over a six
(6) months rolling period, three (3) or more FOI or FOA
are attributable to the same part or technical root cause, at its
option, GEHC may ask VC to stop all shipments to GEHC (“Stop
Shipment”) for all the spare parts or Products potentially
impacted by such defect until a corrective action plan has been
implemented.
In such case,
GEHC may, at its sole discretion, without incurring any liability
or cancellation fee, partially or totally cancel its orders for
such parts or Products previously forecasted per Section 6.5
for delivery between the beginning of the Stop Shipment up to the
full implementation of the corrective action plan.
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15.2
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Product Reliability
. The Mean Time Between
Failure (Herein referred to as “MTBF”) for the Products
shall not be less than [CONFIDENTIAL] for the System, a
failure being defined as a Malfunction of the software or hardware
which totally prevents the use of the system for its fundamental
clinical usage and when such malfunction cannot be recovered unless
making the parts replacement / software upgrade by the authorized
service engineers. Failures caused by normal wear and tear and
user-induced damage will not be subject to this measurement. If the
Reliability of the Products is lower than the above minimum
targets, VC shall promptly submit to GEHC a written corrective
action plan, which at a minimum contains an analysis of the root
cause(s) and specific actions taken or planned to correct the
reliability weakness, including but not limited to the development
of an FMI as defined in Section 4.1.
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15.3
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Late Deliveries
. VC acknowledges that
timely delivery of conforming Products is of the essence of this
Agreement. VC shall notify GEHC immediately if VC ever has reason
to believe that any Product will not be delivered as ordered, or a
shipment will not be made as scheduled. In connection with this
notification:
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The
delivery goal for all Products is 100% on-time delivery. This rate
shall be calculated periodically by GEHC as the number of on-time
deliveries Ex-Works VC Facility or within five days prior to the
scheduled delivery date during a rolling three month period
divided by the total number of deliveries during the same
period. If on-time delivery falls below 95%, VC shall consult with
GEHC and promptly develop a corrective action plan satisfactory to
GEHC in its reasonable discretion.
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Notwithstanding anything to the
contrary herein, If VC on-time delivery falls below 80%, GEHC may,
without incurring any liability or cancellation fee, partially or
totally cancel its orders for the Products late for Delivery by
more than 5 days from the originally scheduled delivery date,
unless the delay is due to GEHC’ breach of this Agreement or
Force Majeure.
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ARTICLE 16.
REGULATORY AND COMPLIANCE
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16.1.
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General . VC shall comply with the
GE’s Integrity Policies, a copy of which is attached as
Attachment E, and all applicable laws and regulations in the
manufacturing and delivery of the Products or in otherwise
performing any of its obligations under or in connection with this
Agreement or any other agreements. Such laws may include, but not
limited to, United States, Danish, French and foreign medical
device laws, regulations and directives, labor laws, environmental
laws, Customs Trade Partnership Against Terrorism
(CTPAT) regulation and product safety laws. VC further
represents and warrants that: (i) VC and its suppliers will
not use child, forced of prison labor in connection with the
manufacture and supply of Products; (ii) VC and Its employees
will not offer gifts, bribes, kickbacks, free travel or other cash
or non-cash incentives to GEHC’ employees. VC will provide
GEHC all information necessary to enable GEHC to comply with the
laws and regulations applicable to GEHC’ use of
Products.
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16.2.
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VC
will at its own expense, apply for and obtain all regulatory
approvals from the FDA and all other governmental and regulatory
approvals, to the extent required to market, sell and distribute
the Products, and comply with the most current governmental and
other regulatory standards with respect to the Products as may be
supplemented or revised from time to time. VC will be responsible
for coordinating the efforts and taking the lead with respect to
such approvals. To the extent permitted by law, all regulatory
approvals obtained by VC and GEHC related to the Products shall be
made in VC’s name and, jointly in GEHC’ and VC’
name, where necessary for GEHC to be able to promote, distribute
and support the Products
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16.3.
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Product Certification
. VC shall manufacture
the Products in strict compliance with all applicable listings such
as CE, UL, IEC, CSA and FDA/Quality Safety Regulatory (for medical
devices), SFDA, CCC or equivalent listing and maintain the same at
its expense. Unless otherwise agreed to in writing, if a Party
proposes a change in purchase specifications pursuant to
Article 17, such Party shall be responsible for any additional
product certification costs that may be necessary. Upon GEHC’
request, VC shall provide GEHC with a copy of all regulatory
certification reports. VC shall also comply, at its own costs, with
international quality standards such as ISO 9001:2000 and ISO
13485. VC shall maintain all above mentioned files and listing
according to specifications in a continuous way and communicate
same, upon request to GEHC, for the period required by applicable
laws so as to enable GEHC never to be in breach of such laws
pursuant to which the applicable authorities may require during the
lifetime of the Products evidence of such Products certification
and listings.
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16.4.
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Medical Device Reporting
. Pursuant to the
FDA’s and other European and foreign applicable Medical
Device Reporting regulations, if either Party is required to report
to the FDA or European notified bodies information that reasonably
suggests that a Product may have caused or contributed to the death
or serious injury or has malfunctioned and that the device would be
likely to cause or contribute to a death or serious injury if the
malfunction were to recur then each of VC and GEHC agree to supply
to the other any such information promptly after becoming aware of
it so that each of VC and GEHC can comply with governmental
reporting requirements. Each Party will use commercially reasonable
efforts to comply with all applicable
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governmental
reporting. Subject to Section 4.1, in the event that VC is
required by any regulatory agency to recall a Product, or if VC or
a regulatory authority initiates a Product recall, GEHC will
cooperate with and assist VC in locating, and retrieving if
necessary, the recalled Products from GEHC’ End Users. All
recalls of the Products arising from manufacture defects will be at
VC’s cost and expense.
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16.5.
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Customs Compliance
. VC agrees to provide
GEHC with all necessary information and assistance to complete the
Product’s Data Records («PDR») and all other
customs documentation required by law. This information shall
include, without being limited to, the Product, spare parts or
Option descriptions and characteristics, part number, dimensions,
weight, dangerous goods information, country of origin, name of
Original Equipment Manufacturer («OEM»)
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ARTICLE 17.
CHANGES IN PURCHASE SPECIFICATIONS
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17.1.
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GEHC-Proposed Changes
. GEHC may propose
changes to the Purchase Specifications or to the Product or part
thereof by submitting the proposed changes (identifying those
changes which it deems mandatory to make the Product suitable for
use) to the Agreement Manager of VC, utilizing the Product Change
Notice (PCN). VC shall respond in writing to the agreement manager
of GEHC within ten (10) days after receipt of such changes
with the following information, as applicable: (i) lead time
required to implement proposed changes; (ii) impact of
proposed changes on pricing of Product, including parts and tools;
(iii) impact of proposed changes on scrap material and work in
process; and (iv) non-recurring engineering charges to
implement proposed changes. Within no more than ten (10) days
after GEHC receives VC’s response to GEHC’ proposed
changes, the Parties shall begin negotiations with respect to the
above changes and any related changes to the price and delivery
schedules. If the Parties fail to negotiate appropriate changes to
the Agreement, the terms in effect prior to the commencement of the
negotiations shall remain in full force and effect.
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17.2
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VC-Proposed Changes
. VC may not make any
changes to the Product affecting form, fit, function, reliability,
serviceability performance, functional interchangeability, options
or spare parts interchangeability or interface capability without
obtaining GEHC’ prior written approval by submitting a change
notice, at least ninety (90) days before the change Is
implemented. If VC makes any such change to a Product without
GEHC’ written approval, VC shall be responsible for the costs
incurred by GEHC in order to fix such issue. When GEHC realize that
it will have to incur some major costs or expenses due to
some VC unproved changes, GEHC shall not engage major costs
and expenses without immediately notifying VC, and the Parties
shall define the best course of action to repair or replace the
affected products or part thereof at GEHC’ facility or
GEHC’ End-User site regardless of whether the Product is in
or out of warranty. VC shall then be responsible for the
corresponding direct costs, expenses or damages, labor and material
costs to be further incurred by GEHC (excluding indirect damages or
lost of revenues) in order to repair the affected
Products.
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ARTICLE 18.
ELECTRONIC DATA INTERCHANGE
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18.1.
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Access . GEHC, in its sole discretion, may
permit VC to have on-line access to designated computer systems of
GEHC in order to facilitate VC’s ability to perform its
obligations under this Agreement. If such access is granted, VC
shall give to GEHC the names of VC’s employees who have a
legitimate business need for such access to GEHC’ computer
systems, and GEHC shall provide a separate user identification code
for each person. VC, at its own expense, shall provide and maintain
any hardware, telecommunications services and software not
furnished by GEHC, which are needed to communicate reliably with
GEHC’ computer systems. GEHC, in its sole discretion, may
terminate VC’s access to GEHC, computer network at any
time.
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18.2.
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Use Restrictions
. VC shall ensure that:
(i) computer access is limited to those employees with a
legitimate business need whose names have been furnished to GEHC;
and (ii) such employees with access agree to keep any information
so obtained strictly confidential, to use such information only to
perform VC’s contract obligations to GEHC and to cease
accessing GEHC’ computer systems when no longer required to
perform work under this Agreement. VC shall promptly notify GEHC if
it becomes aware of any unauthorized access to GEHC’ computer
systems or unauthorized use of the information on the
systems.
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18.3.
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Legal Effect . Any document properly transmitted
by computer access shall be considered a writing delivered in
connection with this Agreement. Electronic documents shall be
considered signed by a Party if they contain an agreed upon
electronic identification symbol or code. Electronic documents
shall be deemed received by a party when accessible by the
recipient on the computer system. Electronic documents that can
possibly lead to one Party’s material breach of this
Agreement, shall be acknowledged by the receiving Party.
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ARTICLE 19
— LIABILITY — INSURANCE
Notwithstanding
anything to the contrary herein contained,GEHC shall have no
obligation at anytime to purchase or distribute any Product, and
GEHC shall have no indemnification obligations to VC.
VC agrees to
indemnify, defend, and hold GEHC and its directors, officers,
employees, Representatives, agents, third parties and End-Users
harmless from and against any and all claims (including those for
personal injury or death), losses, damages, obligations,
liabilities and costs (including attorney’s and other
professional fees and other costs of litigation) arising out of or
attributable to: (a) the operation of the Products, including
without limitation, any liabilities attributable to a design
defect, malfunction or other failure of the Products to perform but
only to the extent that any such liability is not attributed to
improper use of the Products by GEHC or End-Users contrary to
VC’s written instructions; (b) the gross negligence
willful misconduct of VC in connection with this Agreement; or
(c) any breach of this Agreement by VC.
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Indemnification Procedures
. In the event that any person
intends to claim indemnification pursuant to the paragraph above
(an “Indemnitee”) it shall promptly notify VC in
writing of such alleged liability, provided that the failure
to promptly notify VC shall not relieve VC of any obligation under
this Agreement except to the extent such failure to provide prompt
notice adversely impairs VC’s ability to defend against the
claim, suit or proceeding. VC shall have the sole right to control
the defense and settlement thereof, provided , that:
(a) VC may not consent to imposition of any obligation or
restriction on the Indemnitee in any settlement unless mutually
agreed among VC and GEHC; (b) VC shall keep Indemnitee fully
informed and permit the Indemnitee to participate (at
Indemnitee’s expense) as the Indemnitee may reasonably
request; and (c) Indemnitee may, without affecting its right
to indemnity hereunder, defend and settle any such claim, suit or
proceeding if VC declines to defend against such claim, suit or
proceeding, Files for Bankruptcy. The Indemnitees shall cooperate
with VC and its legal representatives in the investigation of any
action, claim or liability covered by this Article 19. The
Indemnitee shall not, except at its own cost, voluntarily make any
payment or incur any expense with respect to any claim or suit
without the prior written consent of VC, which VC shall not be
required to give, provided that the Indemnitee may, without
affecting its right to indemnity hereunder, defend and settle any
such claim, suit or proceeding if VC declines to take
responsibility, Files far Bankruptcy.
Further
Limitation .
Notwithstanding any other provision of this Agreement, each Party
hereby waives any and all claims towards the other Party for
indirect, incidental or consequential damages, and to any sums on
account of loss of goodwill, income of profit or other special
damages, even if the other Party has been advised of the
possibility of such damages and losses.
Insurance
for VC . VC represents,
warrants and covenants that, as of the date hereof and as of the
date of signature of this Agreement, VC has and will have insurance
policies with a reputable insurance policy not disapproved by GEHC,
but which name should be communicated by VC to GEHC in writing not
later than 10 days after the signature of this Agreement. In
addition, VC agrees: (i) to maintain the Insurance policy with
coverage levels of at least USD 2,000,000 per occurrence. At
GEHC’ reasonable request, VC will deliver to GEHC a
certificate of insurance.
ARTICLE 20
— OWNERSHIP OF INTELLECTUAL PROPERTY
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20.1
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Ownership of Pre-Existing VC
Intellectual Property . Subject to the license and
ownership rights set forth in this Agreement, sole and exclusive
right title and interest to current VC products, all Patents and
all other intellectual property rights associated with the current
VC products, including any copyrights or trade secrets, shall
remain with VC (“Pre-existing VC Intellectual
Property”).
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20.2
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Ownership of GEHC Intellectual
Property .
Sole and exclusive right, title and interest to all GEHC products
and any intellectual property contained therein or related thereto,
including any patents, copyrights or trade secrets, shall remain
with GEHC (“Pre-existing GEHC Intellectual
Property”).
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20.3
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Ownership of Inventions and
Improvements
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(i)
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VC Inventions.
VC shall have and retain
sole and exclusive, right, title and interest to all inventions,
improvements, discoveries and know-how which, during the term of
this Agreement, are solely made by, or solely at the expense of, VC
during the term of this Agreement are solely made by, or solely at
the expense of VC, its employees, sublicensees, contractors or
agents acting under authority from VC (“VC Inventions”,
together with all intellectual property rights associated therewith
and together with the Pre-existing VC Intellectual Property, the
“VC Intellectual Property”).
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(ii)
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GEHC Inventions.
GEHC shall have and
retain sole and exclusive right, title and interest to all
products, inventions, improvements, adaptations, enhancements,
interfaces, documentation, discoveries and know-how which, during
the term of this Agreement, are solely made by, or solely at the
expense of, GEHC, its employees, sublicensees, contractors or
agents acting under authority from GEHC (“GEHC
Inventions”, together with all intellectual property rights
associated therewith and together with the Pre-existing GEHC
Intellectual Property, the “GEHC Intellectual
Property”).
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(iii)
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Joint Inventions.
In the event that VC and
GEHC desire to engage in the joint development of a new product /
feature (“Joint Inventions”), VC and GEHC shall
negotiate in good faith to agree upon the terms under which the
parties will jointly develop such Joint Invention. Including,
without limitation the allocation of development expenses and
responsibilities, maintenance and support responsibilities, joint
ownership of intellectual property rights, with both parties having
unrestricted royalty-free rights to use the technology. There shall
be reciprocal indemnity for intellectual property contributed by
the other party plus maximum cap on intellectual property liability
commensurate with each party’s potential upside benefit. The
parties shall use their reasonable efforts to agree upon reasonable
terms governing the treatment of Joint Inventions within thirty
(30) days of electing to create Joint Inventions.
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(iv)
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Subject to Section 20.3.(i) and
20.3 (ii), and unless agreed otherwise during the Term of this
Agreement, VC and GEHC shall have joint rights over jointly
developed improvements and enhancements to the Product.
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21.1
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All Necessary License
Rights .
Subject to the provisions of this Agreement, including Section 21.2
herein, VC hereby grants to GEHC all license rights to any of the
VC Intellectual Property necessary to allow GEHC to perform its
obligations and exercise its rights under this Agreement, including
but not limited to those set forth in Article 2 above. The
Term of each license granted under this Section 21.1 shall be
concurrent with the Term, but shall survive indefinitely and
irrevocably with respect to Products marketed, distributed and sold
prior to termination of this Agreement or as provided under
Section 22.4.
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21.2 License
Grant and Effectiveness
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(i)
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Subject to Section 21.2
(ii) below, VC hereby grants to GEHC a non-exclusive,
fully-paid royalty free, perpetual license (with right to
sublicense, the “ License ”) to VC Intellectual
property, to use ,
execute, reproduce, display, perform, distribute, modify, create
derivative works of, make, have made, market, offer for sale, sell,
import and sub-license the Products land parts thereof)
incorporating, or covered; by, VC Intellectual Property.
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(ii)
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The
License shall only become effective in the event that (i) if
VC ceases operations or Files for Bankruptcy without appointing a
successor reasonably acceptable to GEHC, or (ii) if VC
materially and repeatedly breaches its maintenance and support
obligations under Article 11 thus preventing GEHC to service
existing installations of the Products. In addition, the parties
agree that if this Agreement is terminated or rejected by a party
in bankruptcy, then all rights and licenses granted under or
pursuant to this Agreement shall be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code and any similar Laws in
any other country in the Territory, licenses of rights to
“intellectual property” as defined under U.S.
Bankruptcy Code. The Parties agree that all intellectual property
rights licensed hereunder, including, without limitation, any
technology, software, patents or patent applications in any country
of a Party covered by the license grants under this Agreement, are
part of the “intellectual property” as defined under
the Bankruptcy Code subject to the protections afforded the
non-terminating Party under Section 365(n) of the Bankruptcy Code,
and any similar law or regulation in any other country.
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(iii)
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Technical Information.
Upon the occurrence of
any of the events in Section 21.2 (ii) above, the License
shall automatically become effective without the requirement of any
action by either party, and VC shall promptly make available to
GEHC, at no cost to GEHC, access to all source code and spare parts
suppliers necessary to service all Product(s) or spare parts
delivered during the Term of this Agreement. GEHC shall thereafter
have full right to use such information for the sole purpose of
repairing or replacing spare parts and supporting the installed
Product base without any claim on VC’s part for additional
compensation for such use. However, GEHC shall be responsible for
the cost of the repair or replacement of spare parts by third party
spare parts suppliers.
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21.3
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No
licenses are granted, by implication, estoppel or otherwise, under
any intellectual property right of GEHC under this
Agreement
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ARTICLE 22
— INTELLECTUAL PROPERTY RlGHTS INDEMNITY
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22.1
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VC
hereby covenants that it will not knowingly include in any of the
Products and any parts or sub-assemblies thereof or End User
documentation anything that, nor will VC knowingly enter into a
situation where the sale or distribution by GEHC of any of the
Products or End User documentation as approved by VC, or the use of
such products or documentation by GEHC’ End Users, infringes,
or includes any product or parts or sub-assemblies thereof that
infringes, any third party’s patent,
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trademark,
trade secret copyright or other intellectual property right. As of
the date of this Agreement, VC has received no notice of
infringement from any source. The issued Patents are valid and
enforceable. The Patents, together with additional technical
information to be acquired or developed by VC or provided by VC to
GEHC, represent all intellectual property rights of VC, or
non-infringing intellectual property of its suppliers, necessary
for GEHC to perform its obligations and enjoy its rights under this
Agreement.
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22.2
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VC
warrants that the Product shall be delivered free of any claim of
third parties for infringement of any intellectual property rights
patent or copyright. VC, at its own expense, shall defend,
indemnify and hold harmless GEHC and its directors, officers,
employees, agents, successors and assigns, and defend any action
brought against same with respect to any claim, demand, debt,
liability, damage, cost, loss or expense, including
attorneys’ fees and expenses, based on a claim that the
development, promotion, manufacture, use, sale or other disposition
of, or servicing of the Product furnished under this Agreement, by
VC, infringes or violates any patent, copyright, trade secret,
license, or other proprietary right of any third party. VC shall
control such defense and all negotiations relative to the
settlement of any such claim; provided, however, that VC shall not
enter into any settlement or compromise that adversely affects any
rights of or imposes any obligation or liability on GEHC without
the prior consent of GEHC. Upon VC’s request and at
VC’s expense, GEHC will provide VC with the assistance,
information, and authority reasonably necessary to perform the
above defense, and VC shall reimburse GEHC for reasonable
out-of-pocket and legal expenses incurred in providing such
assistance. GEHC shall promptly provide VC with written notice of
any claim which GEHC believes fails within the scope of this
Article; provided, however, that failure by GEHC to provide such
notice shall not affect VC’s obligations under this Article
to the extent that VC is not materially prejudiced
thereby.
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22.3.
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At
any time after VC becomes aware of any such claim but prior to any
injunction or final resolution of such claim, GE may request VC use
commercially reasonable efforts to procure for GEHC the right to
continue to use the Product, and any portion thereof.
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22.4.
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In
the event that the Product, or any portion thereof, is held to
constitute an infringement and its use is enjoined, VC shall have
the obligation to, at its option and at its own expense:
(i) modify the infringing Product without impairing in any
respect the functionality or performance, so that it is
non-infringing; (ii) procure for GEHC the right to continue to
use the infringing Product; or (iii) replace the Product with
an equally suitable, non-infringing replacement subject to GEHC
reasonable acceptance testing. If none of the foregoing
alternatives are available to VC, GEHC shall receive, in addition
to its rights and remedies available to it under this Agreement and
pursuant to law, a repayment of all m
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