exv10w28



 








Exhibit 10.28



[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 16th 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:




ARTICLE 1.
DEFINITIONS.




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.





	2.1	 	Product definition





The Products as further defined in Attachment A, shall consist of:




	a)	 	The VC s5i System complying with following specifications:






	 	•	 	Primary CPU assembly with all acquisition, processing and I/O boards
	 
	 	•	 	VH circuitry and algorithms integrated with Primary CPU Assembly
	 
	 	•	 	Mounting bracket
	 
	 	•	 	LCD color Monitor
	 
	 	•	 	Data entry devices: Keyboard, track ball and point & click interfaces and
roll-up carts if necessary.
	 
	 	•	 	Input power from 100 to 240 VAC, 50/60 Hz




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	 	•	 	ECG trigger card
	 
	 	•	 	Digital frame grabber
	 
	 	•	 	DVD Drive
	 
	 	•	 	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”)
	 
	 	•	 	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.
	 
	 	•	 	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.
	 
	 	•	 	Installation and Service Manuals in English
	 
	 	•	 	Packaging for Air / Road transportation
	 
	 	•	 	All “Special” installation tools and fixtures.
	 
	 	•	 	Regulatory approvals per Section 2.1 c)
	 
	 	•	 	Languages for User Manuals Graphical User Interface messages, Safety related
messages and labels per Section 2.1 c)






	b)	 	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.
	 
	 	 	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.
	 
	 	 	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.
	 
	c)	 	Regulatory Approvals, Manuals and languages






	 	(i)	 	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
	 
	 	•	 	US FDA Approval
	 
	 	•	 	UL
	 
	 	•	 	WEEE compliant
	 
	 	•	 	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, ...)
	 
	 	•	 	Accompanying document for the Products must include Installation and Service
Manuals in English
	 
	 	•	 	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, ...)






	 	(ii)	 	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:






	 	•	 	CCC Approval
	 
	 	•	 	SFDA Approval
	 
	 	•	 	System level name and rating plate in Chinese, warning labels in Chinese and CCC
mark shall be applied to the Products before shipping.
	 
	 	•	 	Accompanying document for the Products must include Operator Manuals in Chinese
	 
	 	•	 	Accompanying document for the Products must include Installation and Service
Manuals in English






	 	(iii)	 	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.
	 
	 	(iv)	 	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.
	 
	 	(v)	 	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.
	 
	 	(vi)	 	GEHC will obtain the appropriate regulatory approvals for the
“Innova IVUS” as defined in Section 2.1 b).





2.2 Development





	 	(i)	 	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.
	 
	 	(ii)	 	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.
	 
	 	(iii)	 	The Parties agree that VC shall comply with the following development
milestones:





	 	 	 	 	 
	Date	 	Task	 
	[CONFIDENTIAL]
	 	[CONFIDENTIAL]







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	Date	 	Task
	[CONFIDENTIAL]
	 	[CONFIDENTIAL]







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	Date	 	Task	 
	[CONFIDENTIAL]
	 	[CONFIDENTIAL]








	 	(iv)	 	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.
	 
	 	(v)	 	VC agrees at all times to offer GEHC a competitive Product with regards to
other existing systems available on the market.






	2.3	 	Purchase and Distribution of Products.






	 	(i)	 	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.
	 
	 	(ii)	 	Distribution will be performed by GEHC directly or through other members of the
GEHC Group.






	2.4	 	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	 	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.





ARTICLE 3. EXCLUSIVITY





	3.1	 	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.
	 
	3.2	 	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.
	 
	 	 	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.
	 
	 	 	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.
	 
	 	 	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.
	 
	 	 	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.
	 
	3.3	 	Japan distribution rights for the 5i and s5i/GE will be subject to separate negotiation and
agreement, should parties desire to pursue.






9/39










 







	3.4	 	Exclusivity and distribution rights shall continue in the event of any change of control
of VC ownership.
	 
	3.5	 	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.
	 
	3.6	 	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.
	 
	3.7	 	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.
	 
	3.8	 	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.





ARTICLE 4. RESPONSIBILITIES OF THE PARTIES





	4.1.	 	VC responsibilities
	 
	 	 	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
	 
	 	•	 	Developing s5i and s5i/GE under VC’s quality and regulatory framework with
appropriate input from GEHC
	 
	 	•	 	Supporting GEHC in the integration of the s5i/GE and s5i with the GEHC Cardiovascular
systems
	 
	 	•	 	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)
	 
	 	•	 	Supplying the s5i and the s5i/GE to GEHC
	 
	 	•	 	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.:






	 	 	 	o  CE Marking
	 
	 	 	 	o  US FDA Approval
	 
	 	 	 	o  UL/CSA
	 
	 	 	 	o  CMDCAS (Canada)
	 
	 	 	 	o  SDA (China)
	 
	 	 	 	o  CCC(China)






	 	•	 	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.
	 
	 	•	 	Subject to Section 2.1 c), Developing, translating and implementing End
user interfaces messages
	 
	 	•	 	Subject to Section 2.1 c), developing, translating and providing the
End-Users Operator Manuals with each Product in the following
languages:






	 	 	 	o  English



	 
	 	 	 	o  German
	 
	 	 	 	o  French
	 
	 	 	 	o  Spanish
	 
	 	 	 	o  Portuguese
	 
	 	 	 	o  Italian
	 
	 	 	 	o  Chinese






	 	•	 	Performing the end user application training for the s5i and the s5i/GE sold by
GEHC within reason and per standard industry practice
	 
	 	•	 	Defining and providing GEHC personnel with the appropriate Installation and
Service Training (Train the Trainer) in accordance with Article 10.
	 
	 	•	 	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.
	 
	 	•	 	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.
	 
	 	•	 	Providing information and supporting GEHC in the commercial promotion of the Products
in the Territory.




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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:






	 	 	 	o  PQRs: Significant quality or technical issue
	 
	 	 	 	o  CSOs: Customer
Satisfaction issues
	 
	 	 	 	o  PSRs: Safety issues






	 	•	 	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.
	 
	 	•	 	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)
	 
	 	•	 	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






	4.2.	 	GEHC responsibilities
	 
	 	 	Throughout the duration of this Agreement, and notwithstanding anything herein contained, GEHC
shall be responsible and bear the corresponding costs for:






	 	•	 	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
	 
	 	•	 	Providing VC with some specified training on certain GEHC’ applicable
processes (Sourcing, Service, Support, etc)
	 
	 	•	 	Participating in design reviews specifically of s5i/GE as and when requested
by VC
	 
	 	•	 	Offer the s5i and the s5i/GE as part of its Cardiovascular and Interventional
Radiology product lines
	 
	 	•	 	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.
	 
	 	•	 	Shipping and Installing and Servicing the Products sold by GEHC in accordance
with VC’s instructions.
	 
	 	•	 	Coordinate application training with VC personnel for the s5i and s5i/GE systems
sold by GEHC




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	 	•	 	Offer ongoing service under a GEHC service contract for the s5i and s5i/GE systems
sold by GEHC.
	 
	 	•	 	Providing its expertise and support to VC in relation with certification in
countries requiring a local representative (FDA 510K, MHW, SDA).
	 
	 	•	 	Obtaining the appropriate regulatory approvals for the “Innova IVUS” SW feature as
defined in Section 2.1 b).
	 
	 	•	 	Loading the “Innova IVUS” SW feature onto the CardioVascular systems to be
interfaced with the s5i/GE.
	 
	 	•	 	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.
	 
	 	•	 	Validating the Service and Operator Manuals satisfactorily drafted by VC.
	 
	 	•	 	Collecting End-User and service feedbacks from the Pilot sites and
communicating them to VC.
	 
	 	•	 	Defining and developing collaterals to promote the Products, including brochures,
datasheets, trade shows.
	 
	 	•	 	Providing training to its own GEHC’ designated Sale, Service personnel subject
to Article 10
	 
	 	•	 	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.
	 
	 	•	 	Regularly providing VC with market feedbacks on Products specifications and
performances for the purpose of improving the Products competitiveness.





ARTICLE 5 PILOTS





	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”.
	 
	 	 	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.
	 
	5.2	 	The purpose of GEHC installing the Pilots at End-Users sites will be to ensure that:






	 	•	 	The Products meet or exceed End-User expectations,
	 
	 	•	 	The Products can be easily installed and serviced by GEHC,
	 
	 	•	 	The GEHC Service, GEHC On Line Centers personal are satisfactorily trained,
	 
	 	•	 	The Product Service documentation and Operator documents are available and
of good quality.




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	 	•	 	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.
	 
	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
	 
	 	•	 	For any Product to be sold in the US, the Product is UL and FDA 510K approved,
and
	 
	 	•	 	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.




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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.




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	 	•	 	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.
	 	 
	 
	 	 	 	 
	 

	 	[CONFIDENTIAL] to [CONFIDENTIAL] units
	 	$ [CONFIDENTIAL]






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	 	[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].






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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









 






	 	 	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.





ARTICLE 8. PURCHASE ORDER RELEASES





	8.1.	 	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.
	 
	 	 	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.
	 
	8.2.	 	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
	 
	8.3.	 	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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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.



ARTICLE 9. DOCUMENTATION





	9.1.	 	 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.
	 
	9.2.	 	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.





ARTICLE 10. TRAINING





	10.1	 	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.
	 
	10.2	 	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.





ARTICLE
11. SPARE PARTS, SERVICE CAPABILITY AND SUPPORT





	11.1.	 	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.	 	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.
	 
	11.3.	 	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).
	 
	11.4.	 	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.
	 
	11.5.	 	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].
	 
	11.6.	 	VC shall repair any spare part returned by GEHC within one
(1) week from reception date.
	 
	11.7.	 	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:






	 	Ÿ	 	PQRs: Significant Quality or technical issues:






	 	 	 	o VC shall complete the
assessment within 5 Days from notification
	 
	 	 	 	o VC shall do its commercially reasonable effort to implement a fix within 30 Days from notification






	 	Ÿ	 	CSOs: Customer Satisfaction Issue






	 	 	 	o VC shall complete the assessment within 5 Days from notification






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	 	 	 	o VC shall do its commercially reasonable effort to implement a fix within 30 Days from notification






	 	Ÿ	 	PSRs: Safety issues






	 	 	 	o shall complete the assessment within 2 Days from notification
	 
	 	 	 	o VC shall do its commercially reasonable effort to implement a fix within 30 Days from notification






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	 	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.
	 
	 	13.2	 	Payment by GEHC.
	 
	 	 	 	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.
	 
	 	13.3	 	Payment by VC of GEHC’s Image Co-Registration
Services.
	 
	 	 	 	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:





General Electric Company

GE Healthcare Technology

Interventional Cardiology and Surgery Business

3000 N Grandview Blvd

Waukesha 53188

Wisconsin, USA




ARTICLE
14. WARRANTY-REPAIR





	14.1.	 	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.
	 
	14.2	 	Return of Non-conforming or Defective part of a
Product.
	 
	 	 	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.
	 
	14.3.	 	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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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.




	14.4	 	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.
	 
	14.5	 	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.
	 
	14.6	 	All repaired of replaced spare parts to be sent to GEHC, should be processed in accordance
with Attachment H.





ARTICLE 15. PERFORMANCE MEASUREMENTS





	15.1.	 	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:
	 
	 	 	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.
	 
	 	 	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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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.




	15.2	 	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.
	 
	15.3	 	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:
	 
	 	 	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.
	 
	 	 	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.





ARTICLE
16. REGULATORY AND COMPLIANCE









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	16.1.	 	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.
	 
	16.2.	 	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
	 
	16.3.	 	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.
	 
	16.4.	 	 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.




	16.5.	 	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»)





ARTICLE 17. CHANGES IN PURCHASE SPECIFICATIONS





	17.1.	 	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.
	 
	 
	17.2	 	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





	18.1.	 	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.
	 
	18.2.	 	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.
	 
	18.3.	 	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.





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





	20.1	 	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”).
	 
	20.2	 	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”).
	 
	20.3	 	Ownership of Inventions and Improvements






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	 	(i)	 	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”).
	 
	 	(ii)	 	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”).
	 
	 	(iii)	 	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.
	 
	 	(iv)	 	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.





ARTICLE
21—LICENSE





	21.1	 	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.





21.2 License Grant and Effectiveness




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	 	(i)	 	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.
	 
	 	(ii)	 	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.
	 
	 	(iii)	 	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.






	21.3	 	 	No licenses are granted, by implication, estoppel or otherwise, under any
intellectual property right of GEHC under this Agreement





ARTICLE
22 — INTELLECTUAL PROPERTY RlGHTS INDEMNITY





	22.1	 	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.




	22.2	 	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.






	22.3.	 	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. 






	22.4.	 	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 monies paid to VC pursuant to
this Agreement, plus any costs incurred by GEHC in the removal of such Product
and installation of alternative products, and VC shall accept return of the Products
at its expense, once GEHC has arranged for the continuation of the functions
performed thereby.





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ARTICLE 23. TERM AND TERMINATION





	23.1	 	Term. The term of this Agreement is from the date first written above, until
December, 31 2009, (the “Initial Term”). An Extension Term may be executed if there
is mutual agreement with the Parties.






	23.2	 	Termination of Purchase Orders. GEHC may terminate any Purchase Order in whole
or in part at any time upon written notice to VC pursuant to the provisions of
Attachment F. GEHC’ maximum liability with respect to the terminated Purchase
Order shall correspond to the material commitments pursuant to Article 6





23.3
Termination of Purchase Agreement.





	 	(i)	 	If there is a material breach of any term of this Agreement by VC and
VC fails to correct such breach within ninety (90) days after receiving written
notice of such breach from GEHC, GEHC may terminate this Agreement
and all unfilled Purchase Orders without any liability except for the payment of any Products
previously ordered by and delivered to GEHC (subject to any
set-off/compensation/credit available to GEHC).
	 
	 	(ii)	 	GEHC may also terminate this Agreement immediately by giving written
notice to VC if VC foils to meet its financial obligations as they become due, or
Files for Bankruptcy or if VC is unable to supply the Products because of a decision
to exit the business. Any such termination shall not relieve VC of its obligations
and GEHC shall retain all legal and equitable remedies after such
termination. A
material breach by VC shall include, without limitation, the failure by VC to comply
with any Attachment and with applicable product quality and delivery obligations.
	 
	 	(iii)	 	In the event that GEHC fails to purchase and install at least [CONFIDENTIAL] s5i
and s5i/GE systems (taken together) for any 12-month period (rolling) from the first
production shipment of the s5i/GE to GEHC (for reasons not related to pattern of
repeated channel conflict issues between the Parties which materially impact
GEHC’s ability to meet these criteria, where in such case the Parties shall
seek resolution) both VC and GEHC shall have the option to unilaterally terminate
this Agreement (with 30 days notice and cure period). In the event of such
termination:






	 	•	 	All distribution rights shall terminate (for s5i and s5i/GE)
	 
	 	•	 	Certain terms of the agreement will survive per Section 23.6
	 
	 	•	 	VC shall fulfill GEHC’s order backlog and all End User orders
resulting from quotes issued by GEHC prior to the Termination of the Agreement.
	 
	 	•	 	Accrued and future Image Co-Registration Services per Section
7.3 due to GEHC for systems installed prior to termination date shall remain as per this Agreement.






	23.4	 	Fulfillment of Orders upon Termination. Upon termination of this Agreement by GEHC
or VC, GEHC will have the right, at its sole option, to require VC to satisfy VC’s
obligations under all outstanding Purchase Orders that have been accepted by VC prior to the
effective date of termination, as well as fulfill GEHC End User orders





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resulting
from quotes issued by GEHC prior to the termination of the Agreement. After
the termination of this Agreement, to the extent that GEHC has, possession of units of the
Products that it has not distributed or sold to third parties, GEHC will have the right to
market, distribute, and sell such Products in the Territory pursuant to the terms hereof on
a non-exclusive basis. Notwithstanding anything herein to the contrary, in the event that
GEHC is under obligation by statute to distribute or sell Products in the Territory to any
End User or in any country after expiration or termination of this
Agreement, then the
parties shall try to agree upon the terms applicable to such situation, and if not agreed
promptly, the delivery, payment, support and other applicable terms and conditions of this
Agreement will remain in effect as to such End Users or countries, as the case may be,
until such obligation ceases.




	23.5.	 	Effects of Termination. Termination or expiration of this Agreement will not
relieve either Party of obligations incurred prior to the termination.






	23.6	 	Survival of Certain Terms. The provisions of
Article 1, 7.3, 11, 16, 19, 20, 21, 22, 23
(only to the extent necessary to give effect to this Section 23.6), 24, 27, and 28. will
survive the termination or expiration of this Agreement for any reason along with any
obligations which by nature and as per this Agreement are deemed to survive its termination
and expiration.





ARTICLE 24. CONFIDENTIAL INFORMATION



Definition. For purposes of this Agreement, “Confidential Information”  will
mean information, including without limitation, product information and financial, technological
and commercial information of a Party or any third party, exchanged between VC and GEHC pursuant
to this Agreement and the performance of the Parties’ obligations hereunder. Confidential
Information also will include, without limitation, the terms and conditions (but not the
existence) of this Agreement. Each Party may disclose Confidential Information of the other to its
employees, affiliates, agents, professional advisors, consultants or authorized representatives
(“Representatives’’); provided that such Party’s Representatives will be informed of the
confidential nature of such Confidential Information and the obligations of such Party under this
Article. Each Party agrees to take the same measures to preserve the confidentiality of the
Confidential Information of the other as it does for its own Confidential Information. Without the
prior written consent of the other Party, neither Party will use or allow the use for any purpose
of any Confidential Information of the other Party, except for the purposes contemplated or
allowed by this Agreement or by the licenses granted hereunder. In addition, each Party will hold
all Confidential Information of the other in confidence and will not publish, disclose, or allow
disclosure of, any Confidential Information of the other Party to any
other person or entity except to its Representatives, in each case only to the extent necessary to permit such
Representatives to assist such Party in performing its obligations or exercising its rights
under this Agreement, or except as specified in this Article 24.



No Confidentiality. The confidentiality and non-use obligations will not apply to
Confidential Information, which (a) is in the public domain or subsequently enters the public
domain other than as a result of an unauthorized disclosure by the receiving Party or its
Representative; (b) became available to the receiving Party on a non-confidential basis prior to
its disclosure to such Party by the other Party or its
Representatives, (c) becomes




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available to the receiving Party on a non-confidential basis from a source other than the
other Party or its Representatives, provided the receiving Party had no actual knowledge that such
person was under a legal obligation to refrain from such disclosure, or (d) was independently
developed by the receiving Party without reference to such Confidential Information and can be so
shown by documentary evidence.



Ownership. Except as specifically provided herein, all Confidential Information will
remain the sole and exclusive property of the disclosing Party, and this Agreement will not limit
in any way the right of the disclosing Party to enter into agreements with third Parties granting
rights of any kind to its Confidential Information.



Compelled Disclosure. Except as required by law (including, without limitation,
disclosure requirements of the U.S. Securities and Exchange Commission, or any stock exchange on
which securities of a Party are traded), neither Party will issue any press release or otherwise
make any public statements with respect to the transactions contemplated by this Agreement without
the prior consent of the other Party, which will not be unreasonably withheld or delayed. In the
event of a required public disclosure, to the extent practicable under the circumstances, the
Party making such disclosure shall provide the other Party with a copy of the proposed text prior
to such disclosure and with financial terms sufficiently in advance of the scheduled release of
such disclosure to afford such other Party a reasonable opportunity to review and comment upon the
proposed text. If a Party is otherwise required (pursuant to legal process or otherwise) to
disclose any Confidential Information of the other Party, such Party agrees to provide the other
Party with prompt notice of each such required disclosure, to the
extent practical, so that the
other Party may seek an appropriate protective order or confidential treatment. If, absent the
entry of a protective order or confidential treatment, a Party or its Representatives are legally
compelled or required to disclose Confidential Information of the other Party, such Party may
disclose such information to the persons and to the extent required without liability under this
Agreement.




Confidential
Documentation. Each Party will destroy or return to the other Party all
unneeded Confidential Information on an on-going basis during the Term. Upon expiration or
termination of this Agreement and at the request by the disclosing Party, all Confidential
Information of the disclosing Party in the possession of the other
and copies will be returned
immediately or, upon request by the disclosing Party, destroyed, except that one copy of such
Confidential Information may be retained in the legal files of the Party receiving such
Confidential Information solely for compliance purposes or for the purpose of defending or
maintaining any litigation (including any administrative proceeding) relating to this Agreement
or such Confidential Information. No such termination or return or destruction of such
Confidential Information by a Party will affect such Party’s obligations under this Agreement
(including its obligations to ensure compliance with the provisions of this Agreement by its
Representatives), all of which obligations will continue in effect.



Term. Upon termination of this Agreement, each Party will be prohibited from using the
other Party’s non-public information (which in the case of GEHC includes GEHC End User
information) gained through performance of the transactions contemplated by this Agreement to
directly or indirectly compete with the other Party, without the prior written consent of the
other Party. The obligations with respect to any item of Confidential Information will survive
for a period of four (4) years from the date of the disclosure of such




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item of Confidential Information or until three (3) years after the termination of this
Agreement, whichever is later.




ARTICLE 25. AGREEMENT MANAGER



Each party shall appoint an agreement manager as the point of contact for all matters relating to
performance of this Agreement. GEHC’ agreement manager shall be
the Global Sourcing Leader —
Sourced Systems and VC’s agreement manager shall be Associate Marketing Director, OEM Programs
Either party may change its agreement manager by providing notice of such change to the other
party.




ARTICLE 26. NOTICES — CRISIS MANAGEMENT





	26.1	 	Notices. Any notice required under this Agreement shall be sent by fax (with the
original to promptly follow by applicable national mail service or a nationally recognized
overnight courier), by a nationally recognized overnight courier, or
transmitted electronically pursuant to the terms of Article 18. Notices will be deemed given on the date
delivered to the recipient if sent by fax or overnight courier (it being agreed that the
sender shall retain proof of transmission or delivery, as the case
may be) or when accessible
electronically if sent electronically under Article 18. Notices
shall be sent to the
persons identified below (or as otherwise directed in writing by a
party):


GEHC:

Attention:      GE Medical Systems — GM Vascular Marketing


VC:

Attention:      Volcano Corporation — CEO





26.2   Crisis Management





Communications. VC must maintain the ability to contact GEHC on a 24 hour a
day, 7 day a week basis in order to communicate and manage crisis situations that threaten
to or interrupt the Supply Chain. Likewise, VC must be available if GEHC wishes to contact
the VC on a 24/7 basis. Means of communication may include, but are not limited to, phone,
mobile phone or pager and interaction via email and the Internet.




Business Contingency Plan (BCP). VC must share with GEHC a BCP that includes the
VC’s plan for 24/7 communication with GEHC. The BCP will also include basic information on
the VC’s upstream Supply Chain. For instance, this information
will include who the VC’s
Tier 1 and Tier 2 suppliers are, where they are located and the means of transportation
for this Supply Chain.



ARTICLE
27. GOVERNING LAW / LITIGATION




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	27.1	 	The present Agreement will be governed and interpreted by the State of New York
Law, without giving effect to its conflict of laws principles.






	27.2	 	All disputes between the parties in connection with, or arising out of, the existence,
validity, construction, performance and termination of this Agreement or any terms
whatsoever thereof, which the parties are unable to solve amicably between themselves, shall
be settled by binding arbitration under the Rules of Conciliation and Arbitration of the
International Chamber of Commerce (ICC). Any such arbitration shall be conducted in the
English language, and the venue of such arbitration shall be New York
City, NY, USA.





ARTICLE 28. MISCELLANEOUS





	28.1	 	Scope. THIS AGREEMENT AND ITS ATTACHMENTS STATE THE TERMS AND
CONDITIONS UNDER WHICH VC SHALL SELL TO GEHC, AND GEHC SHALL PURCHASE
FROM VC ON A NON EXCLUSIVE BASIS, THOSE PRODUCTS IDENTIFIED IN
ATTACHMENT A, AS WELL AS ALL COMPONENTS, SPARE PARTS, SERVICE TOOLS,
MANUALS, SOFTWARE LICENSES, DATA AND RELATED INTERFACES WITH RESPECT
THERETO. UNLESS OTHERWISE EXPRESSLY STATED, REFERENCES TO THIS
“AGREEMENT” INCLUDE ALL ATTACHMENTS.






	28.2	 	Parties. VC expressly acknowledges that this Agreement is not intended to govern
or obligate any business, division or affiliate of GEHC other than GE Medical Systems
business, and that the term “GEHC” as used herein shall refer to the GE Medical
Systems business and to no other business, division or affiliate of General Electric
Company.






	28.3	 	Documents. The following attachments are an integral part of this Agreement (the
“Attachments”). The provisions of each Attachment shall be incorporated by
reference into and be deemed to be a part of this Agreement. If any conflict exists
between the provisions of this Agreement and of the Attachments and documents
mentioned below, or between the provisions of Attachments and documents
mentioned below, the order of precedence shall be:






1.
  This Agreement




2.   Attachment B (Purchase Specifications — Factory Acceptance Test)




3.   Attachment A (product description, configuration, datasheet, and/or brochure)




4.   Attachment D (Spare parts Pricing Schedules and Lead-times)




5.   Attachment E (GE Integrity Policies)




6.   Attachment J (Initial Orders for Pilots)




7.   Any Purchase Order released by GEHC




8.   Attachment F (Standard Terms and Conditions)




9.   Attachment G (Product Change Notice Form)




10. Attachment H (Repair Information and Packaging)




11. Attachment I (Purchased Material Quality Requirements)




12. Attachment M (Countries of the Territory that Currently Maintain
Exclusive Distribution Agreements with VC)



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13. Attachment N (EU language policy)




	28.4	 	Severability: In the event any provision of this
Agreement, or portion thereof, shall be deemed invalid or unenforceable by any court or governmental,
agency, such provision shall be enforced to the maximum extent permissible so as
to effect the intent of the parties. All remaining provisions shall continue in
full force and effect.






	28.5	 	No Waiver: The waiver or failure of either Party to exercise any right or remedy in
any respect provided for herein shall not be deemed a waiver of any
further right or remedy hereunder.






	28.6	 	Audit Right: At GEHC’ request, VC will
allow GEHC to inspect without charge and to copy at GEHC’ expense any
documents you have relating to the performance of VC’s obligations
under this Agreement.






	28.7	 	Except as permitted pursuant to Article 24, VC
and GEHC shall not issue any press
release or announcement, use any of each others’ products or its
name in promotional activity, or otherwise publicly announce or comment on
this Agreement without GEHC’ or VC’ prior written consent.”






	28.8	 	This Agreement, may not be assigned by VC or
GEHC without the express written consent of GEHC on the one hand and VC on the other.






	28.9	 	This Agreement may be modified only by a writing
signed by the Agreement Managers for both Parties.




IN WITNESS WHEREOF, the undersigned has executed this Agreement as of the
date first written above.




	 	 	 	 	 	 	 	 	 	 	 
	GEHC

	 	 	 	 	 	VC	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Jean Louis Baudet
 

	 	 	 	By:
	 	/s/ Scott Huennekens
 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name: Jean Louis Baudet	 	 	 	Name: Scott Huennekens	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title: Modality
Sourcing Leader ICS	 	 	 	Title: President & CEO	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	GEHC

	 	 
	 	 	 	VC	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Jean Pierre Zajac
	 	 	 	By:	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name: Jean Pierre Zajac	 	 	 	Name:	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title: GM Sourcing
Europe	 	 	 	Title:	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 





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TABLE OF ATTACHMENTS




Attachment
A (Product description, configuration, datasheet and/or brochure)

Attachment B (Purchase Specifications — Factory Acceptance Test)

Attachment D (Spare parts Pricing Schedules and Lead-times)

Attachment E (GE Integrity Policies)

Attachment F (Standard Terms and Conditions)

Attachment G (Product Change Notice Form)

Attachment H (Repair Information and Service Packaging)

Attachment I (Purchased Material Quality Requirements)

Attachment J (Initial Orders for Pilots)

Attachment L (Prices for the Products)

Attachment M (Countries of the Territory that Currently Maintain Exclusive Distribution agreements with VC)

Attachment N (EU language policy)




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Attachment A

Product description, configuration, datasheet and/or brochure




 









 








	 	 	 	 	 
	 

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	Marketing Product Manager:                      Nancy Perry Pool
	 	Date: September 30, 2005     






1. PROJECT NAME/NUMBER                      S5I, #IF-006





2. INDICATIONS FOR USE



The VOLCANO s5i Imaging System is used for the qualitative and quantitative evaluation of
vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also
indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen
and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral
and coronary vasculature; flow information can be an adjunct to other methods of estimating blood
flow and blood perfusion.




3. DESCRIPTION



The Volcano s5i is an IVUS (intravascular ultrasound) system based on the functionality
derived from the s5 system, including ChromaFlo and other features
inherent in the s5. It uses some
of the same internal circuit boards as the s5 — the analog and digital boards, and other cards when
they become available. It consists of the following major system components:





1. CPU — This box is about 16” square and about 6 inches deep. It contains a mother board with
Pentium M microprocessor, 2 GB of system RAM, one 3.5” hard drive, a medical grade power supply,
the s5 IVUS card, and a remote control interface card. A maximum of two control panels and two remote
LCD monitors can be connected to a CPU for remote operation. It is designed to be compact, light
weight, and quiet. It will incorporate mechanical mounting features to allow it to be mounted under the
table either on a 6 inch stationary stand or lower mobile stand, next
to the table foot.




2. Control Station — The s5i control panel and slide out keyboard are mounted in a custom
designed plastic enclosure. This box can be mounted on a support arm from a patient table DIN rail or
from an articulated wall mount. It can be placed on a table in the control room or it can be mounted to a
roll around IV pole cart. It is attached by means of one cable to the CPU. It can also be located on a table
near a local 15” medical grade display which is wired to clone the main LCD image, if desired. This
will require an additional cable from the CPU to the remote LCD display. The control station will have an
additional USB port so that it can also be connected to a USB printer




3.
LCD Monitor — The 19” s5 LCD monitor will be used to display images from the IVUS CPU. It
will be mounted to an articulated arm that is attached to the patient table near the ''foot
end” of the table. The mounting arm will have enough degrees of motion freedom that the LCD
monitor can be rotated and positioned so that it is entirely under the patient table and out of
the way if desired.




4.
Archive Station (optional) — Data can be moved from the CPU by Ethernet to a DICOM workstation
for storage of burning to DVD. It can then be taken to a DVD burner equipped workstation PC for
review or burning to a DVD. However, to provide archival capability for customers that do not have this
hardware, we will offer an optional small table top workstation, a commercial 15” LCD containing a
computer and a DVD writer. This workstation will connect by means of a single Ethernet cable to the CPU.
The files stored on the CPU hard drive can then be moved to the workstation for review and archiving
to a DVD without impacting the Operation of the CPU. An optional color dye sublimation printer can be
attached to the workstation to permit image printing.




5.
Interconnect Cabling — Because the CPU is mounted below the patient table, the wiring to and
from the CPU will be routed to the remotely located control panels and LCD monitors by cabling strung



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across the floor, under suitable cable covers. For components like the cath lab control
panel and the PIM, cables will be routed directly from the CPU to these components. Because the
LCD monitor is also mounted to the patient table, in close proximity to the CPU, a direct VGA
cable connection is made. The remaining cable is CPU AC power which should be available from an
AC outlet on or near the patient table mounting pedestal. There is no AC power required for
the control panels attached to the CPU.




6. Portability Enhancements — The s5p or portable system will simply use the same hardware as
the CPU from the s5i. It will be mounted in a carrier to allow it to be easily transported. The
control panel and archiving station can be transported by carriers designed for them. If desired, an optional
collapsible cart, chosen from one of many commercially available models will also be offered. A small
commercially available 15” LCD monitor is lightweight and easy to carry in a display carrier.




7.
Installation — Because of the commonality of DIN mounting rails in cath labs, a set of rail
mounting hardware will be made available to allow customization of the mechanical installation to meet
the unique requirements of each cath lab.




8.
Interoperability — The CPU has an Ethernet connection to allow connection to the hospital
LAN, DICOM workstation, archive workstation, or remote control consoles from GE, Siemens or other
manufacturers. This requires the addition of a software module to interpret these remotely issued
commands and provide the proper response in the s5i.



Clinical Applications



The system allows assessment of: vessel wall morphology, lumen characteristics, thrombus formation,
and delineates arterial walls and wall thickness using an imaging catheter. In addition, it allows
for measurement of lumen diameter, vessel wall thickness, and cross-sectional areas and, with the
ILD feature, longitudinal measurements. It provides additional diagnostic information as an adjunct
to or in combination with percutanous interventional therapies such as balloon angioplasty, or
atherectomy. It generates a sagittal view of vessel for lesion diagnosis.




WARNINGS



Use of the Volcano Imaging System is contraindicated wherever tissue or organ damage is a
reasonable probability.




4. PROJECT OBJECTIVES AND GOALS





	 	1.	 	Design and develop an IVUS system to be permanently mounted in the Cath Lab for use at
the patient table
	 
	 	2.	 	Provide a system that can drive remote external LCD, Plasma and CRT displays

	 
	 
	 	3.	 	Provide for remote control panel operation in the Cath Lab and/or the Control Room
	 
	 
	 	4.	 	Provide for attaching up to two remote image displays from the s5ii system
	 
	 	5.	 	Utilize same hardware as s5i to create s5p and s5g systems





5. CUSTOMER REQUIREMENTS





	 	Customer’s desire: 
	 
	 	5.1	 	Traditional IVUS capabilities
	 
	 	5.2	 	Physically integrated into the cardiac catheterization lab





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	 	5.3	 	A simple to operate product
	 
	 	5.4	 	Application quickly available
	 
	 	5.5	 	Little or no training to operate the product
	 
	 	5.6	 	The ability to document and store the data from the procedure
	 
	 	5.7	 	A clear/crisp image
	 
	 	5.8	 	The ability to bookmark interesting areas





Customer Requirement




5.1 Customer’s desire no less performance than they have with the In-Vision product line


s5i will be one in a family of IVUS machine offerings that will be the replacement for the
In-Vision line due to part obsolescence and technology advances. This product must perform like a
traditional IVUS machine.




Clinical Benefit




Certain functionality is expected from the user. A new product must meet these expectations
in order to be used for patient benefit.




Features
and Performance Requirements

Image Displays





	 	5.1.1	 	System will support combination tomographic and sagittal views.






	 	o	 	Tomographic IVUS image.
	 
	 	o	 	Sagittal view either vertically or horizontally simultaneous with tomographic
display.
	 
	 	o	 	All measurements need to be displayed on imaging views.
	 
	 	o	 	Data capture and display: record video loops and still images
	 
	 	o	 	Ability to replay or review captured images Data capture and display

	 
	 	o	 	Record video loops and still images






	 	5.1.2	 	Display information:






	 	o	 	Display in English
	 
	 	o	 	Additional languages include: French, Italian, German, Spanish languages -
deferred to version 2
	 
	 	o	 	Volcano logo
	 
	 	o	 	Patient demographic information
	 
	 	o	 	Current date,
time, software version.
	 
	 	o	 	Patient co-morbidity data
available in the patient screen.






	 	5.1.3	 	Measurements: distances, areas, longitudinal distances, and
borders.





Catheter support:





	 	5.1.4	 	Support all current Volcano cardiovascular and peripheral IVUS catheters and
will have the ability and flexibility to support new catheter designs.





Instrument Set Up / Functions





	 	5.1.5	 	Standard local XGA video output will be provided, also 2 remote video outputs.
	 
	 	5.1.6	 	Output for network (DICOM), Ethernet RJ-45 connector
	 
	 	5.1.7	 	Will use standard Patient Interface Module, located within 30 feet of the CPU
	 
	 	5.1.8	 	Connector on CPU chassis to allow use of the control panel, trackball or keyboard, 2
max.
	 
	 	5.1.9	 	System will support communication with a new design remote archiving station for
color image printing and DVD recording of patient data, 1 max





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Customer Requirement




5.2 Customers desire a unit physically integrated into the Cardiac Catheterization Lab




Storage and ready access of equipment is a challenge in the hospital environment. By
integrating the unit into the cath lab the equipment is always in place and ready to use.




Clinical Benefit




A physically integrated unit will be always be available and eliminates the need for
storing equipment. Patients who can benefit from IVUS will because there will always be
equipment available.




Features & Performance Requirements




Mechanical Design





	 	5..2.1	 	System will have all computer components and PCBs integrated into a small,
reduced weight, housing, suitable for mounting on, or near the patient table in the
Cath Lab and within 30 feet of the patient in the Control Room or Equipment Room.
	 
	 
	 	5..2.2	 	A control panel, derived from the s5 will be mounted from the DIN rails on the patient
table in the Cath Lab and/or the Control Room and connect to the CPU by a single cable.
It should also be provided with mounting hardware to mount it from a roll around
equipment cart or from a wall. It should have suitable rubber feet so that it can be
placed on a table top without marring the finish.
	 
	 
	 	5..2.3	 	Approx. CPU dimensions: 16” x 16” x 6” (H x W x D).
	 
	 
	 	5..2.4	 	Approx. CPU Weight: < 30 lbs.
	 
	 
	 	5..2.5	 	Approx. Control Panel Dimensions: 10” x 16” x 4” (H x W x D.)
	 
	 
	 	5..2.6	 	Approx. Control Panel Weight: <10 Ibs.
	 
	 
	 	5..2.7	 	The CPU must be capable of being attached to patient table. The mounting system must
be designed for easy installation by a field service tech.
	 
	 
	 	5..2.8	 	The Control Panel enclosure must be attachable to a boom/arm/mount that can be
mounted on or to the control area of the patient table. It should also be capable of
being mounted to a roll around IV pole cart. It should also be possible to place it on
a flat table for desktop use.





Display





	 	5..2.9	 	Volcano Custom OEM Flat Panel Monitor: nominally 19” diagonal display area.
	 
	 
	 	5..2.10	 	Monitor screen visible in reduced light cath lab environment with minimal distortion
when viewed from side or off angle (up to 30 degrees off angle).
	 
	 
	 	5..2.11	 	Contrast & brightness and image vertical size adjustment capability required.

	 
	 
	 	5..1.12	 	The display will be mounted on an articulated arm that allows the display position to
be changed from stowed under the patient table, to easily visible at the patient
table.
	 
	 
	 	5..2.13	 	The display should be provided with a table mount for remote display
locations.





Control Panel





	 	5..2.12	 	The Control Panel will connect to the CPU and allow operation of the s5i GUI and
patient data entry using the pull out keyboard. The Control Panel can be mounted on or
near the patient table, on a freestanding mobile IV pole carrier, or from an articulated
wall





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	 	 	 	mounted arm, depending on customer preferences.
	 





Archiving Station





	 	5.2.13	 	A remote archiving station will be provided to permit file transfer from the Cath
Lab integrated CPU and burning patient files to a DVD from a direct Ethernet connection to the CPU. It will
be located in the control room.





Customer Requirement




5.3 Customers desire a simple to operate product




Clinical Benefit




The
simpler a product is to operate, the more time it saves, the more confidence it gives
the user thus translating into increased product use.




Features and Performance Requirements 


User
Interface




	 	5..3.1	 	Will offer an intuitive, easy to use interface with minimal menus and minimal levels of
operation.
	 
	 	5..3.2	 	Primary operator control will be through on screen curser and screen
controls on the LCD/CPU display.
	 
	 	5..3.3	 	Additional controls, for measurement or dialog boxes will include a trackball and a
keyboard.
	 
	 	5..3.4	 	An archiving station will consolidate the tasks of saving data, printing data
&/or networking data.





Customer Requirement




5..4 Customers desire the ability to have the application quickly available




Clinical Benefit




Long boot-up times discourage the use of the IVUS equipment because clinicians are always in a
hurry and time is money. Busy labs don’t have time to move machines from room to room to
accommodate large patient case loads. Building the s5i into the patient table will encourage its
use. Using the s5i will improve the information the clinician has to determine the best course of
treatment for the patient; this contributes to a better patient outcome.




Features
& Performance Requirements





	 	5..4.1	 	Application is always on.
	 
	 	5..4.2	 	PC Boot up time less than 120 seconds
	 
	 	5..4.3	 	After PC boot-up the system is ready to go imaging in less than 60 seconds
or less. The software and hardware will be properly initialized and calibrated during this time.
Any errors in this process will be reported to the user, such as equipment setup, calibration
and catheter initialization





Customer Requirement




5.5 Customers desire little or no training to operate the product




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Training takes time and money. With staff turn over the less training a product requires
the better and the more likely the product will be used. In addition, if there is no one
properly trained to operate the equipment it will not be used.




Clinical Benefits




Using the s5i IVUS machine will improve the information the clinician has to determine
the best course of treatment for the patient; this contributes to a better patient outcome.




Features and Performance Requirements





	5.5.1	 	Console button design will follow the typical clinician
workflow  – designed to be
intuitive for the casual user
	 
	5.5.2	 	On screen step by step (“wizard”) available





Customer Requirement




5.6 Customers desire the ability to document and store the data from the procedure




Clinical Benefit




Documentation is required for reimbursement and legal proof of treatment. The customer
must be able to document the procedure in several forms of media such as paper and electronic.




Features & Performance Requirements




Data
Storage:





	 	5.6.1	 	Primary Storage Medium: Internal CPU hard drive(s).
	 
	 	5.6.2	 	Secondary Storage: Media will be DVD-R disks for archival purposes.
	 
	 	5.6.3	 	Tertiary Storage: Hospital DICOM server via the PACS network.
	 
	 	5.6.4	 	Ability to review of data on systems from both primary and secondary sources.
	 
	 	5.6.5	 	Ability to view Volcano images on a computer, such as in their office or home
	 
	 	5.6.6	 	Minimum three, 90 second video loops stored @ 30fps
	 
	 	5.6.7	 	Will not support legacy Volcano CD-R IVUS disks





Archiving Station





	 	5.6.9	 	A remotely located archiving station will be provided that connects to the
CPU by means of a direct Ethernet cable connection.
	 
	 	5.6.10	 	Data can be burned to a DVD-R.
	 
	 	5.6.11	 	The archiving station will provide a USB connector to attach a USB printer for
color image hard copy.





Customer Requirement




5.7 Customer desires a clear/crisp image




Image clarity can be a driving force in the brand of machine that is selected to use for
IVUS procedures. The clearer the image the more useful the equipment is to the clinician.




Clinical Benefit




Clear images improve the ability of the clinician to accurately diagnosis the patient’s
problem and select the appropriate course of care.




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Feature
& Performance Requirements





	 	5.7.1	 	Image Quality: Meridian system will have grayscale IVUS imaging quality equivalent to
or better than current IVG Imaging System
	 
	 	5.7.2	 	Ability to adjust the live image.





Customer Requirement




5.8 Customer desires the ability to bookmark interesting areas



During a pullback when an interesting image appears, the customer would like to mark the area.
The bookmark gives them the ability to view it at a later time




Clinical Benefit



Giving the clinician the ability to quickly locate a problem anatomic area will save time,
reduce frustration and ultimately improve patient outcome, assuming the treatment is driven by this
information




Feature Performance requirements





	 	5.8.1	 	Mechanical button on the console labeled bookmark
	 
	 	5.8.2	 	Mechanical button sends a software command to place a mark on the ILD.
	 
	 	5.8.3	 	The mark will be archived and available on the archived case.





6. TARGET MARKETS



This
product will be available globally. Phased introduction will be into
U.S., Japanese, and
European markets and will require FDA and CE marking. Second phase of
introduction will be ROW..




7. TARGET USERS





	 	 	§  Hardware
operators/“Button-pushers”






	 	 	o  	 RN’s
	 
	 	 	o  	CV technicians
	 
	 	 	o  	Volcano field personnel






	 	 	§  Decision makers/Data Interpreters






	 	 	o  	Physicians





8. Field Service




    Expect field service to support the product for up to ten years.




    Field service will install the system and wiring.




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	 	Input	 	 
	 
	 

	 	Control Number: 806105-002/001	 	 
	 
	 	 	 	 
	Marketing Product Manager:

	 	Nancy Perry Pool
	 	Date: December 9, 2005
	 	 	 	 	 
	1.
PROJECT NAME/NUMBER 

	 	S5I-GE
	 	 








2. INDICATIONS FOR USE



The VOLCANO s5i-GE Imaging System is used for the qualitative and quantitative evaluation of
vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also
indicated as an adjunct to conventional angiographic procedures to provide an image of vessel
lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from
peripheral and coronary vasculature; flow information can be an adjunct to other methods of
estimating blood flow and blood perfusion.




3. DESCRIPTION



The Volcano s5i-GE is an IVUS (intravascular ultrasound) system based on the functionality
derived from the s5 system, including ChromaFlo and other features inherent in the s5. It uses some
of the same internal circuit boards as the s5 — the analog and digital boards, and other cards when
they become available. It consists of the following major system components:





1.
CPU — This box is about 16” square and about 6 inches deep. It contains a mother board
with Pentium M microprocessor, 2 GB of system RAM, one 3.5” hard
drive, a medical grade power supply, the
s5 IVUS card. and a remote control interface card. A maximum of two control panels and two remote
LCD monitors can be connected to a CPU for remote operation. It is designed to be compact, light
weight, and quiet. It will incorporate mechanical mounting features to allow it to be mounted under the
table either on a 6 inch stationary stand or lower mobile stand, next to the table foot.




2.
Control Station — The s5i-GE control panel and slide out keyboard are mounted in a
custom designed plastic enclosure. This box can be mounted on a
support arm from a patient table DIN rail
or from an articulated wall mount. It can be placed on a table in the control room or it can be
mounted to a roll around IV pole cart. It is attached by means of one cable to the CPU. It can also be
located on a table near a local 15” medical grade display which is wired to clone the main LCD image, if
desired. This will require an additional cable from the CPU to the remote LCD display. The control station
will have an additional USB port so that it can also be connected to a USB printer




3.
GE InnovaCentral Touch Screen and Joystick — The LCD will have an IVUS tab. When the IVUS
tab is selected on the touch screen this activates IVUS and the system can acquire data. Volcano
will send a request to Innova for patient data, then Innova sends
patient data to Volcano. This
enables the right ID to configure Volcano as a series on the PACS system right along side Innova images for
the same patient. The user workflow is as follows:




4.
GE Monitor Display Cluster — The IVUS screen appears on the monitor assigned to IVUS
using GE’s video signal routing system, if desired.




5.
LCD Monitor (optional) — The 19” s5 LCD monitor will be used to display images from the
IVUS CPU. It will be mounted to an articulated arm that is attached to the patient table near the
“foot end” of the table. The mounting arm will have enough degrees of motion freedom that the LCD monitor can
be rotated and positioned so that it is entirely under the patient table and out of the way if
desired.




6.
Archive Station (optional) — Data can be moved from the CPU by Ethernet to a DICOM
workstation for storage or burning to DVD. It can then be taken to a DVD burner
equipped workstation PC for review or burning to a DVD. However, to provide archival capability
for customers that do not have this hardware, we will offer an optional small table top
workstation, a commercial 15” LCD containing a computer




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and a DVD writer. This workstation will connect by means of a single Ethernet cable to the
CPU. The files stored on the CPU hard drive can then be moved to the workstation for review and
archiving to a DVD without impacting the operation of the CPU. An
optional color  dye
sublimation printer can be attached to the workstation to permit image printing.




7.
GE CA-1000 has the ability to review IVUS images




8.
GE PACS server can receive DICOM IVUS images pushed from the s5i-GE




9.
Interconnect Cabling — Because the CPU is mounted below the patient table, the wiring to and
from the CPU will be routed to the remotely located control panels and LCD monitors by cabling strung
across the floor, under suitable cable covers. For components like the cath lab control panel
and the PIM, Cables will be routed directly from the CPU to these components. Because the LCD monitor is
also mounted to the patient table, in close proximity to the CPU, a direct VGA cable connection is
made. The remaining cable is CPU AC power which should be available
from an AC outlet on or near the
patient table mounting pedestal. A network connection to the CPU is required. There is no AC power
required for the control panels attached to the CPU.




10.
 Interoperability — The CPU has an Ethernet connection to allow connection to the hospital
LAN, DlCOM workstation, archive workstation, or remote control consoles from GE. This requires
the addition of a software module to interpret these remotely issued commands and provide the
proper response in the s5i-GE.



Clinical Applications



The system allows assessment of: vessel wall morphology, lumen characteristics, thrombus
formation, and delineates arterial walls and wall thickness using an imaging catheter. In addition,
it allows for measurement of lumen diameter, vessel wall thickness, and cross-sectional areas and,
with the ILD feature, longitudinal measurements. It provides additional diagnostic information as
an adjunct to or in combination with percutanous interventional therapies such as balloon
angioplasty, or atherectomy. It generates a sagittal view of vessel for lesion diagnosis.




WARNINGS



Use of
the Volcano Imaging System is contraindicated wherever tissue or organ damage is a
reasonable probability.




4. PROJECT OBJECTIVES AND GOALS





	 	1.	 	Design and develop an IVUS system to be built into a new GE Cath Lab
	 
	 	2.	 	Provide a system that can drive remote external LCD, Plasma
and CRT displays
	 
	 	3.	 	Provide for remote control panel operation in the Cath Lab and/or the control room
	 
	 	4.	 	Provide the capability to create a report reflecting the serial numbers of the
catheters that are used with this system.





5. CUSTOMER REQUIREMENTS





	 	Customer’s desire:
	 
	 	5.1	 	Traditional IVUS capabilities
	 
	 	5.2	 	Physically integrated into a GE cardiac catheterization lab
	 
	 	5.3	 	A simple to operate product








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	 	5.4	 	Application quickly available
	 
	 	5.5	 	Little or no training to operate the product
	 
	 	5.6	 	The ability to document and store the data from the procedure
	 
	 	5.7	 	A clear/crisp image
	 
	 	5.8	 	The ability to bookmark interesting areas
	 
	 	5.9	 	IVUS Patient information be available from the GE system





Customer Requirement




5.1
Customer’s desire no less performance than they have with the In-Vision product line



s5i-GE will be one in a family of IVUS machine offerings that will be the replacement for the
In-Vision line due to part obsolescence and technology advances. This product must perform like a
traditional IVUS machine.




Clinical Benefit



Traditional
IVUS functionality is expected from the user. A new product must meet these
expectations in order to be used for patient benefit.




Features and Performance Requirements




Image Displays





	 	5.1.1	 	System will support combination tomographic and
sagittal views.






	 	 	o  	Tomographic IVUS image.
	 
	 	 	o  	Sagittal view vertically simultaneous with tomographic
display.
	 
	 	 	o  	All measurements need to be displayed on imaging views.
	 
	 	 	o  	Data capture and display: record video loops and still images
	 
	 	 	o  	Ability to replay or review captured images Data capture and display
	 
	 	 	o  	Record video loops and still images






	 	5.1.2	 	Display information:






	 	 	o  	Display in English
	 
	 	 	o  	Volcano logo
	 
	 	 	o  	Patient demographic information
	 
	 	 	o  	Current date, time, software version.
	 
	 	 	o  	Patient co-morbidity data available in the patient screen.






	 	5.1.3	 	Measurements: distances, areas, longitudinal distances, and
borders.





Catheter support:





	 	5.1.4	 	Support all current Volcano Cardiovascular and peripheral IVUS catheters and will
have the ability and flexibility to support new catheter
designs.





Instrument Set Up/Functions





	 	5.1.5	 	Standard local XGA video output will be provided, also 2 remote video outputs.
	 
	 	5.1.6	 	Output for network (DICOM), Ethernet RJ-45 connector
	 
	 	5.1.7	 	Will use standard Patient interface Module for phased array catheters, located within
30 feet of CPU
	 
	 	5.1.8	 	Connector on CPU chassis to allow the Volcano control panel, trackball and
keyboard
	 
	 	5.1.9	 	System will support communication with the Volcano remote archiving station for
color image printing and DVD recording of patient data and the PACS system (optional)





Customer Requirement





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5.2
Customers desire a unit physically integrated into the Cardiac
Catheterization Lab

Storage
and ready access of equipment is a challenge in the hospital
environment. By
integrating the unit into the cath lab the equipment is always in place and ready to use.




Clinical Benefit



A physically integrated unit will be always be available and eliminates the need for storing
equipment. Patients who can benefit from IVUS will because there will always be equipment
available. Sharing patient data also eliminates redundant data entry and reduces errors.



Features & Performance Requirements




Mechanical Design





	 	5.2.1.	 	System will have all computer components and PCBs integrated into a small, reduced
weight, housing, suitable for mounting near the patient table in the Cath Lab and within
30 feet of the patient in the Control Room or Equipment Room.
	 
	 	5.2.2.	 	A control panel, derived from the s5 will be mounted from the rails on the patient
table in the Cath Lab and/or the Control Room and connect to the CPU by a single cable. It
should also be provided with mounting hardware to mount it from a roll around equipment
cart or from a wall. It should have suitable rubber feet so that it can be placed on a
table top without marring the finish.
	 
	 	5.2.3.	 	Approx. CPU dimensions: 16” X 16” X 6”(H x W x
D).
	 
	 	5.2.4.	 	Approx. CPU Weight: < 30 lbs.
	 
	 	5.2.5.	 	Approx. Control Panel Dimensions: 10” X 16” x 4” (H x W x D.)
	 
	 	5.2.6.	 	Approx. Control Panel Weight <10 Ibs.
	 
	 	5.2.7.	 	The CPU must be capable of being attached to patient table. The mounting system must
be designed for easy installation by a field service tech.
	 
	 	5.2.8.	 	The Control Panel enclosure must be attachable to a boom/arm/mount that can be mounted
on or to the control area of the patient table. It should also be capable of being mounted
to a roll around IV pole cart. It should also be possible to place it on a flat table for
desktop use.





Display





	 	5.2.9.	 	One monitor on the GE monitor boom will be the IVUS monitor
	 
	 	5.2.10	 	Volcano Custom OEM Flat Panel Monitor: nominally
19“diagonal display area. (optional)
	 
	 	 	 	5..2.10.1 Monitor screen visible in reduced light cath lab environment with minimal
distortion when viewed from side or off angle (up to 30 degrees off
angle).
	 
	 	 	 	5.2.10.2. Contrast & brightness and image vertical
size adjustment capability required.
	 
	 	 	 	5.2.10.3. The display will be mounted on an articulated arm that allows the display
position to be changed from stowed under the patient table, to easily
visible at the patient table.
	 
	 	 	 	5.2.10.4. The display should be provided with a table mount for remote display
locations.





Control Panel





	 	5.2.12	 	The Control Panel will connect to the CPU and allow Operation of the s5i-GE GUI and
patient data entry using the pull out keyboard. The Control Panel can be mounted on or
near the patient table, on a freestanding mobile IV pole carrier, or from an articulated
wall mounted arm, depending on customer preferences.






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	 	5.2.13	 	The IVUS controls are integrated with the GE Innova touch screen, which is in the
sterile field, and have the menus on the touch screen. The menus are under the IVUS tab and have several
buttons replicating functionality of the Volcano control panel. The buttons can be
enabled when the s5 receives the new patient message from Innova. Otherwise, these buttons are
disabled. IVUS Tab selection exposes the IVUS buttons on the touch screen. The buttons on the
Innova touch screen that are mapped to the control panel are as
follows:






	 	 	o  	Record
	 
	 	 	o  	Stop
	 
	 	 	o  	Save Frame
	 
	 	 	o  	Book Mark
	 
	 	 	o  	Play — plays the last acquired pullback
loop
	 
	 	 	o  	Ringdown
	 
	 	 	o  	Pull Back — speed input
	 
	 	 	o  	ChromaFlo
	 
	 	 	o  	Print
	 
	 	 	o  	Measurements
	 
	 	 	o  	End case




Archiving





	 	5.2.13	 	A remote archiving station will be provided to permit file transfer from the Cath Lab
integrated CPU and burning patient files to a DVD from either a USB flash drive or a direct
Ethernet connection to the CPU. It will be located in the control
room.
	 
	 	5.2.14	 	Ability to send (push) DICOM images to the GE PACS server
	 
	 	5.2.15	 	Ability to review images on the CA-1000





Customer Requirement




5.3 Customers desire a simple to operate product




Clinical Benefit



The simpler a product is to operate, the more time it saves, the more confidence it gives
the user thus translating into increased product use.




Features and Performance Requirements




User Interface





	 	5.3.1.	 	Will offer an intuitive, easy to use interface with minimal menus and minimal levels of
operation.
	 
	 	5.3.2.	 	Primary operator control will be through the Innova Touch screen
	 
	 	5.3.3.	 	Additional controls, for measurement or dialog boxes which will include a trackball in the
control panel
	 
	 	5.3.4.	 	Selectable font size on the user interface





Customer Requirement



5.4 Customers desire the ability to have the application quickly available





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Clinical Benefit



Long boot-up times discourage the use of the IVUS equipment because clinicians are always in a
hurry and time is money. Building the s5i-GE into the cath lab will encourage its use. Using the
s5i-GE will improve the information the clinician has to determine
the best course of treatment for the patient; this contributes to a better patient outcome.



Features
& Performance Requirements





	 	5.4.1	 	Application is always on.
	 
	 	5.4.2	 	The system is ready to go imaging in less than 120 seconds. The software and
hardware will be properly initialized and calibrated during this time.





Customer Requirement




5.5 Customers desire little or no training to operate the product



Training takes time and money. With staff turn over the less training a product requires the
better and the more likely the product will be used. In addition, if there is no one properly
trained to operate the equipment it will not be used.




Clinical Benefits



Using the s5i-GE IVUS machine will improve the information the clinician has to determine the
best course of treatment for the patient; this contributes to a better patient outcome.




Features and Performance Requirements





	 	5.5.1	 	Innova touch screen design will follow the clinical workflow as designed on the
Volcano control panel, which includes the Volcano icons
	 
	 	5.5.2	 	On screen step by step (“wizard”) available





Customer Requirement




5.6 Customers desire the ability to document and store the data from the procedure




Clinical Benefit



Documentation
is required for reimbursement and legal proof of treatment. The customer must be
able to document the procedure in several forms of media such as paper and electronic.




Features & Performance Requirements




Data
Storage:





	 	5.6.1	 	Primary Storage Medium: Internal CPU hard drive(s).
	 
	 	5.6.2	 	Secondary Storage: Media will be DVD-R disk for archival
purposes.
	 
	 	5.6.3	 	Tertiary Storage: Hospital DICOM server via the PACS network.
	 
	 	5.6.4	 	Ability to review data on systems from both primary and secondary sources.
	 
	 	5.6.5	 	Ability to view Volcano images on the CA-1000
	 
	 	5.6.6	 	Will not support legacy Volcano CD-R IVUS disks
	 
	 	5.6.7	 	Ability to create a report reflecting the serial number of the catheters that have
been used with this system.





Archiving Station





	 	5.6.8	 	A remotely located archiving station will be provided that connects to the CPU by
means of a










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direct Ethernet cable connection.





	 	5.6.9	 	The archiving
station allows the user to print and save to a DVD





Customer Requirement




5.7
Customer desires a clear/crisp image



Image clarity can be a driving force in the brand of machine that is selected to use for IVUS
procedures The clearer the image the more useful the equipment is to the clinician.




Clinical Benefit



Clear images improve the ability of the clinician to accurately diagnosis the patient’s
problem and select the appropriate course of care.




Feature & Performance Requirements





	 	5.7.1	 	Image Quality: s5i-GE system will have grayscale IVUS imaging quality equivalent to or
better than current IVG Imaging System
	 
	 	5.7.2	 	Ability to adjust the live image.





Customer Requirement




5.8 Customer desires the ability to bookmark interesting areas



During a pullback when an interesting image appears, the customer would like to mark the area.
The bookmark gives them the ability to view it at a later time




Clinical Benefit



Giving the clinician the ability to quickly locate a problem anatomic area will save time,
reduce frustration and ultimately improve patient outcome, assuming the treatment is driven by this
information




Feature Performance requirements





	 	5.8.1	 	Mechanical button on the console labeled bookmark
	 
	 	5.8.2	 	Button on the touch screen labeled bookmark
	 
	 	5.8.2	 	Mechanical button sends a software command to place a mark on the ILD.
	 
	 	5.8.3	 	The mark will be archived and available on the archived case.





Customer Requirement



5.9 Customer desires the IVUS patient information be available from the GE system




Clinical Benefit



Sharing patient data saves time by eliminating redundant data entry and reduces errors.




Feature Performance requirements





	 	5.9.1	 	Patient information appears on the IVUS screen and IVUS archived record
	 
	 	5.9.2	 	Ability to view the images on the GE CA 1000
	 
	 	5.9.3	 	Ability to send (push) DICOM images to the GE PACS server





6. TARGET MARKETS









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This
product will be available globally. Phased introduction will be into
U.S., Japanese,
and European markets and will require FDA and CE marking. Second phase of introduction will
be ROW..




7. TARGET USERS





	 	§	 	Hardware operators/“Button-pushers”






	 	 	o  	RN’s
	 
	 	 	o  	CV technicians
	 
	 	 	o  	Volcano field personnel






	 	§	 	Decision makers/Data interpreters






	 	 	o  	Physicians





8. Field Service



Expect field service to support the product for up
to ten years. 

GE will install the system and wiring.





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The
“s5i/GE” is the “s5i” with integration capability
with the with GE “Innova IVUS” connectivity
option.



Except connectivity, no functional difference between s5i/GE and the s5i



s5i units can be upgraded to s5i /GE



Where
applicable, GE Innova® IVUS can have a tag line “Powered by Volcano” to clarify that IVUS
imaging will be performed by Volcano.









 









 






Attachment B

Purchase Specifications — Factory Acceptance Test




To be updated prior to M3




 









 






Attachments D

Spare parts Pricing Schedules and Lead-times




	 	 	 	 	 	 	 
	Reference	 	Description	 	Leadtime in Weeks	 	Unit Price in Euros
	 
	 	 	 	 	 	 





To be updated prior to M3




 









 






Attachment E

GE Integrity Policies




A. INTRODUCTION



The aim of this document is to provide a summary presentation of the standards of conduct and
the practices that the Parties agree to adopt in respect of certain types of payment on the one
hand and political contributions on the other.



The conduct of each Party in terms of the rules set forth herein constitutes a significant
indication of its capacity of discernment and of its competence. Accordingly, it shall be a
significant criterion in the decision to establish and/or renew contractual relations between the
Parties.




B. STATEMENT OF RULES



The rules described herein comprise three aspects:





	 	a.	 	prohibition of illegal payments,
	 
	 	b.	 	political contributions,
	 
	 	c.	 	money laundering.





B.1 PROHIBITION OF ILLEGAL PAYMENTS



In case where business dealings between the Parties or actions to promote the interests of the
Parties are involved, the latter shall only resort to lawful practices. As indicated below, any
“kickbacks” or “bribes” aiming at facilitating or rewarding orders or decisions by the public
authorities favorable to either of the Parties are unacceptable and prohibited.



In
particular, it is prohibited to make or offer to make any payment whatsoever to:




     1) any person or company employed by a client or a company acting on behalf of a client, whether
private or public, in view of facilitating or rewarding any action of such client that is favorable
to the interests of one of the Parties in the context of a business transaction;



     2) any person or company employed by a public administration or acting on behalf of such
administration with a view to facilitating or rewarding any action (or abstention) by this
administration in a matter that falls within its ambit;



     3) any civil servant, political party, member of a political party or candidate to political office
with a view to facilitating or rewarding any action, abstention, or use of influence favorable to
the interests of either of the Parties in the context of a business transaction or in a political
context.



 









 





For the purposes hereof, it is of no significance whether the prohibited remuneration takes
the form of financial remuneration, gifts, contributions or otherwise



Likewise, it is of no significance whether the offer to make a payment or the payment itself
is made directly or indirectly through an intermediary of a third party or other company.



The present rules shall not apply to the entertainment expenses customary in local business
relations, provided that the amount of these expenses is reasonable. It shall also not apply to any
gifts of low value, inasmuch as such gifts are customary in local business dealings. Such
entertainment expenses or gifts are only authorized under these rules insofar as they are not
prohibited by the law applicable to the business relations concerned.



Where the customer(s), public administrations or other bodies have published procedures
having for their purpose to establish the conditions under which their own employees are authorized
or not to accept gifts or other gratuities, these procedures must be complied with.




B.2 POLITICAL CONTRIBUTIONS



The Parties shall not make any contribution to any political party or candidate to a
political office, except as authorized by the applicable laws.



In such cases, contributions should be made with discernment and in compliance with the legal
provisions. The amount of such contributions should also be reasonable.



This agreement/undertaking does not have for its aim to prevent the communication of the positions
of either of the Parties to members of local or national assemblies, to the public authorities or
to the public at large. For the purposes hereof, the terms “positions of the Parties” relate to
existing legislation, bills or the policy or practices of the State having an impact on business
dealings.




B.3 MONEY LAUNDERING



The Parties shall comply with all applicable laws that prohibit money laundering and that
require the reporting of cash or other suspicious transactions.
Understand how both types of laws
apply to each Party’s business.



In particular, Parties need to identify the types of payments that have become associated with
money laundering activity (for example, multiple money orders or travelers checks, large amounts of
cash, or checks on behalf of a customer from an unknown third party, payment exceeding a given
invoice amount) and follow the rules that restrict or prohibit
acceptance of them.




C. LIABILITY




 









 





Each of the Parties shall be responsible for taking any measure in a timely manner (including any
corrective measure) that may be required in connection with the rules set forth herein




 









 






Attachment F

GEHC Standard Terms and Conditions of Purchase




If there is any conflict between the Agreement and this Attachment F,

the Agreement shall prevail



These Terms and Conditions of Purchase, the purchase order as well as any other document or
specifications referred to therein or in connection therewith issuing from GE Medical Systems, a
French socíété en commandite simple,
having its seat at 283 rue de la Miniére 78530 Buc, enrolled
with the Registry of Commerce and of Companies under the number RCS Versailles B 315 013 359
(“GEHC-Europe”, “us” or “we”), shall collectively constitute the “Purchase Order”. This Purchase
Order shall constitute our offer to the supplier (“Supplier” or “you”) to purchase the products
and/or services ordered in the Purchase Order (referred to individually or collectively as the
“Deliverable(s)”).



You are required to send us a written acknowledgement of receipt of the Purchase Order by fax
and/or by email within a period of forty-eight (48) hours, and no modification to or reservation
in respect of this Purchase Order shall apply unless previously confirmed in writing by us. On the
date of sending of this acknowledgement of receipt or, if no acknowledgement is sent within the
above period, our order will become final and you shall be deemed to have accepted the terms of the
Purchase Order without any exception or reservation and to have waived the application of any other
terms of sale or service, including any reservation of title clause. We hereby object to and reject
any other terms and in no event may we be deemed to have accepted any such terms, even implicitly.
No oral statements shall be binding upon us unless we have confirmed them in writing before they
are implemented. We may transfer our rights and obligations hereunder to the third party of our
choice.



1. ORDER NUMBER. The order number specified on the Purchase Order should be indicated on all
correspondence and documents, including delivery or shipping documents from you, accompanying the
provision of the Deliverable.



2. ELECTRONIC TRANSACTIONS. Both GEHC Europe and the Supplier expressly waive any right to
challenge the validity of the order or of the resulting sale on the sole basis that it was
passed/concluded electronically or in the context of an exchange of electronic documents over the
Internet. GEHC Europe and the Supplier accordingly agree to consider all electronic documents they
may exchange or complete in the context of the said order and sale (HTML pages, electronic mail,
etc.), as original documents with binding effect and to ascribe to any electronic document the same
evidentiary value as a written “original”.



3. DELIVERY TIMES. Unless otherwise accepted by us in writing prior to the fulfillment of the
Purchase Order, compliance with delivery times means delivery of all of the products and/or
services ordered on the Purchase Order on the date and at the location specified therein.
Compliance with delivery times is of the essence to us, without which we would not have
contracted. By confirming the order, you irrevocably agree to comply with these delivery times. Any
partial delivery or performance of the order ascribable to you must be notified to us in advance
and any additional costs this may entail shall be borne by you.




 









 





Without prejudice to any other rights we may have hereunder, we reserve the right, in case of delay
in delivery or performance, to require the dispatch of the products or performance of the services
in the best timely manner, if necessary by resorting to a third-party contractor, at your sole cost
and expense. You agree to immediately inform us if you have any reasons to believe you will be
unable to meet the scheduled delivery date under the Purchase Order. In case of late delivery or
performance the payment date appearing on the corresponding invoice may be deferred by this same
time.



4. QUALITY. You are responsible for the quality of the products and/or services delivered, as well
as for strict compliance with the specifications set forth in the Purchase Order or in any separate
documents that may govern the provision of the Deliverables. Unless otherwise indicated by us in
writing on the Purchase Order or on other drawings or specifications in connection with the
products and/or services ordered, all statutory, official and/or customary standards apply to the
Deliverables.



In case we are or any of our affiliated companies is the holder of the intellectual property rights
over the design of the products or technical processes used for the supply of the service(s) under
a Purchase Order, you are not authorized to subcontract all or part of the performance of the
Purchase Order to a third party, modify all or part of the manufacturing process or the technical
process concerned, change any component, raw material or any other supply required for the
provision of the Deliverable without our prior written consent. In case neither we nor any of our
affiliated companies holds such rights, you are required to advise us of any change in
manufacturing processes or other technical processes likely to modify the features of the products
and/or services delivered as welt as of any subcontracting by you.



For the purposes of this document “affiliated company” means any company directly or indirectly
controlling us, controlled by us or under the control of the same entity as the one controlling us.
The definition of “control” is that provided in
Article L. 233-2 of the French Code of Commerce.



You are responsible for identifying (failing an express indication in the Purchase Order) and
applying any verification measures required to obtain the level of conformity and reliability
required under the Purchase Order and the standards of the trade. You agree to keep written traces
and recordings of the checks, tests and verifications carried out by you, and to furnish them to us
upon our first request. As the Supplier of products and/or services intended for use in a
production capacity you declare being acquainted with and agree to comply with the provisions of
the following document: “Collection of GEHC-E procedures to be
known by Suppliers”.



If your employees are assigned to work on a Deliverable within a site of GEHC-Europe or any one of
its affiliated companies you are required to prepare a prevention plan and submit it to us or to
the affiliated company, as applicable, for written approval. You are also required to inform your
employees of the environmental protection rules, as well as workplace health and safety rules
defined in the approved prevention plan. This prevention plan should be implemented prior to the
commencement of any work by your employees on the sites referred




 









 





to above. If you are a Supplier of potentially hazardous goods you are required to furnish us or
the affiliated company concerned, as the case may be, with the corresponding safety data sheets.



5.
SHIPPING / DELIVERIES. You agree to make shipments of the Deliverables in the quantities, on the
date and at the place indicated on the Purchase Order. Products shall be delivered DDP (Delivered
Duty Paid, Incoterms 2000). All product deliveries should be made during the business hours of the
recipient. Together with the provision of each Deliverable you will remit to us or to the
affiliated company designated by us a delivery slip printed on your official stationery indicating
the date of delivery, the order number appearing on the Purchase Order, the product or service
identification as well as, if applicable, the composition by box or other packaging unit, gross and
net weight, quantity of boxes or other packaging units and quantities missing in relation to those
stated on the Purchase Order. In no event may we be held liable for any delay in payment arising
out of the non-delivery, late delivery,
or delivery of a delivery slip that is incomplete or illegible. In case the products delivered are
perishable, you are required to affix the expiry date on all indivisible packaging units of the
products.



6. ACCEPTANCE / RETURNS. Verification and acceptance of delivery of each Deliverable shall take
place within a reasonable timeframe following delivery but within no less than thirty (30) days.
You may not consider the signature of the delivery slip by us or by any of our affiliated companies
to constitute final acceptance. No Deliverable may be deemed to be accepted by us until
verification of its conformity with the specifications set forth in the Purchase Order, its
intended use and the applicable standards have been carried out. No inspection carried out on your
premises by a government agency or authority or by any other body may defeat the provisions of this
section.



In case the features and/or the quantity of the Deliverables provided are not in compliance with
the indications set forth in the Purchase Order or the other specifications in connection with the
Deliverables, we reserve the right: (i) for products, to refuse acceptance of delivery in full or
in part; you have a period of eight (8) days from the notice sent to you to remove the refused
products, at your sole cost and responsibility; beyond this time we reserve the right, at your cost
and responsibility, either to return to you the products refused, or to warehouse them; and/or;
(ii) to require that you deliver us in the best timely manner the additional quantities of
products, the replacement products and/or, if applicable, that you provide us with the services
ordered once again or complete them; the cost of the additional or replacement products and related
shipping costs and/or the cost of the new services or completion services remaining at your sole
charge; and/or (iii) seek the delivery of the additional or replacement products and/or the
performance of the service(s) from a third-party contractor and invoice all of the ensuing costs
and losses to you. You agree to immediately inform us if you have any reasons to believe that the
products and/or services covered by the Purchase Order will not be delivered as per the
specifications contained therein or in the above-mentioned other specifications.



7. WARRANTY. You represent and warrant to us that the products and/or services delivered shall be
free of any defect and fit for their intended use. You further represent and warrant to us that we
shall have undisturbed use and enjoyment of these products and/or services and that they are not
subject to any intellectual property claim by any of your employees or any third party. Your
acceptance of our Purchase Order entails a commitment by you to warranty





 









 





spare parts and repairs/labor for products delivered for a period of twelve (12) months
following their acceptance of delivery by us.



8. PRICE. Unless otherwise stipulated in writing by us, the prices indicated on Purchase Orders are
firm and not subject to any increase.



For deliveries of products, prices are quoted DDP to the place of delivery specified on the
Purchase Order, net of any other taxes, duties, charges or fees. Packaging may not be returned
for a deposit refund without our prior written agreement. The packaging of products delivered is
required to comply with the specifications set forth in the Purchase Order and/or other
specifications in connection therewith. Failing this, we reserve the right to refuse acceptance of
delivery of the products and/or to pursue the other rights available to us pursuant to section 6
above.



We may deduct from payments owed to you in consideration for the provision of the Deliverable(s)
any tax, duty, employment-related tax or contribution as well as any assimilated charges paid by
us should you fail to provide us with the documents that would have exonerated us from such
payments.



9.
INVOICES. Invoices should be sent to us by post and addressed to Supplier Billing Service, 283
rue de la Minière BP34 78533 Buc cedex, within five (5) days from delivery and indicate the order
number appearing on the Purchase Order, the name and address of the parties, the identification of
the Deliverable(s), the itemization of the price by type of product and/or service ordered, the
total amount of the invoice, the date and reference of the delivery slip, and the shipping method
as well as, where products are concerned, the quantities delivered, the unit of measure and the
unit price. More generally, invoices are required to contain any information required by the
applicable laws or regulations. One invoice per Purchase Order shall be issued.



10. PAYMENT. Subject to the conformity of an invoice issued with the requirements set forth in the
Purchase Order, as well as the compliance of the Deliverables, we shall pay you within the time
period expressly stipulated on the Purchase Order. We may automatically deduct any amounts you owe
us on any basis whatsoever under any order from the amount owed to
you on the basis of a different order. We may set-off the said amounts by right, regardless of whether the legal requirements for
set-offs have been met or not. Any amount not paid on the due payment date by us shall carry a late
payment interest penalty of one and a half times (1.5) the legal interest rate. Interest shall
begin to run by week of continued non-payment following the expiry of a period of eight (8) days
from an official request for payment sent to us by registered mail with return notice that shall
have remained unpaid.



11. INTELLECTUAL PROPERTY. All drawings, documents, plans, models, samples and other proprietary
information or materials communicated to you or with which you shall
become acquainted in the
framework of the fulfillment of a Purchase Order (“GEHC-Europe Proprietary Knowledge”) are and
shall remain our exclusive property and we expressly reserve all of our intellectual property
rights in respect of the foregoing. As a result, both you and all of your subcontractors, where
applicable, agree not to copy or reproduce any of GEHC-Europe’s Proprietary Knowledge in whole or
in part or use it in any way or form whatsoever, except as




 




 









 







strictly
authorized by us in writing. This authorization shall be granted by us
on a non-exclusive
and non-transferable basis for the sole purpose of the provision of the Deliverable concerned and
for the sole duration of this provision.



All developments, computerized or not, studies, reports, documents or other new knowledge, patentable or not, that may be produced/created/collected by you in the framework of the provision
of a
given Deliverable (the “Results”) shall become our exclusive property on an ongoing basis when it
is produced/created/collected, even if you have not yet communicated these Results to us.



This
transfer of right, title and interest concerns all exclusive intellectual property rights
(i.e., industrial property rights as well as literary and artistic
property rights, such as defined below) on a worldwide basis, for the term of validity of such rights, without any
restriction in terms of print runs, broadcasting, rebroadcasting or
use. We may be substituted in
the exercise of all or part of such intellectual property rights by a third party pursuant to a
transfer, assignment, license grant or any other legal method of conveyance. You also agree to
assign to us all tangible property rights in and to the media on which the Results are fixed that
allow for their manufacturing.



The
assignment price is expressly included in the price paid to you for the provision of the
Deliverable concerned.



Where the rights concerned by this assignment concern software products, the assignment shall
cover both the object code and the source code for all of the elements of the Results, including
the preparatory materials and related documentation.



For the purposes hereof literary and artistic property rights mean the exclusive rights referred to
in the first part of the French Intellectual Property Code (Articles
L. 111-1 to L. 335-10),
including neighboring rights and the sui generis rights of producers of databases, for the types
of use listed below regardless of the type of work involved, whether individual, a work of joint
authorship or a collective work: (a) The right to reproduce, duplicate, print, record all or part
of each of the Results, on any media including, but not limited to, paper, films, magnetic bands,
computer or digital formats as well as all media known now or in the future, in all formats, this
right of reproduction comprising the right to permanently or temporarily reproduce all or part of
each Result, in any way and form, including, but not limited to, for any display, execution,
transmission or storage operation on all sites; (b) The right to establish any version, in French
or in any other language, including any computer language, of all or part of each of the Results,
and more generally, the right to translate, arrange, modify, adapt, and transform in full or in
part and in any written, oral, telematics, digital or other form each of these Results for the
purpose of all types of exploitation; (c) The exclusive right to publish, broadcast, edit or
re-edit, exploit, grant or assign user rights, rent or loan in any way, reproductions of all or
part of the Results, in their original version or in a version such as previously defined, whether
free of charge or for a fee; (d) The exclusive right to perform, broadcast and exploit all or part
of each of the Results in their original version or in a version such as previously defined, in any
way including, but not limited to, by television broadcasting and public communication on a wire
or wireless basis, by public projection, by transmission in a public place of the work broadcasted
or communicated to the public, by public presentation or in any other way; (e) The right of error
correction, monitoring and maintenance. Accordingly, we are the sole party authorized to exploit
the Results directly or indirectly subject to compliance with the
applicable legal conditions. In
case the Results are patentable in full or in part, we shall be the sole party




 



 









 







authorized, should we deem it appropriate, to file or have filed by the third party of our choice,
in our name and at our expense, one or more patent applications covering all or part of the
Results in all countries. You shall provide us with your assistance, within the limits of your
capability, in filing at our cost the applications for patents referred to above and in defending
and maintaining any patents obtained. Our ownership of the Results carries with it the
prohibition for you to make use, for your own account or for that of a third party, all or part of
the Results without our prior, express written consent. This prohibition only extends, however, to
Results specifically produced for us and not general knowledge in the public domain or know-how
implemented or developed by you for the purposes of, or in the framework of, the provision of the
Deliverables hereunder. You hereby agree to hold us harmless from and against any breach by you
of these terms of purchase as well as any claim brought against us by a third party, including but
not limited to salaried creators or outside creators having participated in any capacity
whatsoever in the production of the Results.



12.
TRADEMARKS. The name, logo, trademark of each party shall remain their sole and exclusive
property.



13. CONFIDENTIALITY. You agree not to disclose or communicate to any person, or to exploit for
yourself or for a third party, in any way and on any media whatsoever, directly or indirectly,
without our prior written consent, any files, documents, tools, materials, designs, drawings,
plans, models, samples or other elements communicated to you, or of which you acquire knowledge or
which you have produced/created/collected in the framework of the
fulfillment of a Purchase Order. More generally, any information communicated in the framework of a Purchase Order shall be deemed
to be confidential and exclusively proprietary to us and you agree to take any measures required
to prevent the disclosure of any such information. Upon our request, you agree to immediately
return, notably upon the completion of provision of a Deliverable, all of the files, documents,
tools, materials, designs, drawings, plans, models, samples and other elements referred to above.



14. TRANSFER OF TITLE AND RISK OF LOSS. For products, subject to the terms of section 11 above
concerning the transfer of ownership of Results, title and risk shall pass to us upon the delivery
to the locations specified by us in the Purchase Order.



15. FORCE MAJEURE. In case of any event of force majeure, labor conflict or any other event outside
of our control, we disclaim all liability for refusing to accept
scheduled deliveries.



16. COMPLIANCE WITH APPLICABLE LAWS. You represent and warrant to us that in the fulfillment of a
Purchase Order you will comply with all applicable laws and
regulations, including, but without
restriction, those applicable to fraud, intellectual property, environment protection, health and
hygiene, labor and employment law, pricing and customs matters. Without limiting the general nature
of the foregoing, you represent and warrant that the products, their manufacturing and/or the
services provided shall conform with all of the laws and regulations applicable in the medical
domain.



17. TERMINATION. We may terminate the sale agreement resulting from the Purchase Order pursuant to
the preamble hereof by right, without the requirement for court intervention, and without any
indemnities whatsoever being payable to you in case of (i) non-performance by




 





 









 







you of one or more of your obligations under the order concerned and/or (ii) non-compliance by you
or by the products and/or services provided by you with the
applicable laws or regulations. Termination shall become effective ten (10) calendar days after the mailing to you of a notice of
breach by registered mail setting forth the cause for termination, unless you have cured the
breach in full within this period, the a foregoing is without prejudice to any damages we may
claim on the basis of such breach.



18. PUBLICITY. Under no circumstances may you use our orders for direct or indirect advertising or
promotional purposes.



19. GOVERNING LAW / CHOICE OF VENUE. All orders by us and the resulting sales are governed by the
laws of France, without regard to its conflict of laws rules or the provisions of the United
Nations (Vienna) Convention of April 11, 1980 on contracts for the international sale of goods.



All disputes arising between us in connection with, or arising out of the existence, validity,
interpretation, performance and/or termination of a purchase order (or any terms whatsoever
thereof) and/or the resulting sale that cannot be resolved amicably shall be settled by the
competent courts of paris, including in case of summary proceedings,
codefendants, impleader or
contrary provision contained in your standard terms of sale or any of your commercial documents.



 




 









 








Attachment G

Product Change Notice Form




 




 










 






	 	 	 
	 

	 	Before using this document, assure it is the latest revision.
	 

	 	See the Quality Systems Web page for current revision.
	GLOBAL
SOURCING PROCEDURES

	 	http://3.231.180.180/cgi_bin/mfg/manuf/qualityprocedures
I.pl?pm=LIST

If you need assistance consult with your Mfg. Quality Representative

	          GE Medical Systems

	 	 












	 	 	 
	TITLE: Supplier Change Notice Control

	 	PROCEDURE NO: 7.4.2-02GQP
	 
	 	 
	OWNER: GSC EHS and Quality Compliance Manager

	 	PAGE 1 of 4
	 
	 	 
	DATE ISSUED: 5/2004

	 	DUE FOR REVIEW: 5/2006










	I.	 	SCOPE
	 
	 	 	The purpose of this document is to define the criteria for initiating a Supplier Change
Notice and the processes to be used to communicate and implement these change
notices within GEMS and with the suppliers.
	 
	II.	 	REFERENCES
	 
	 	 	3.0.0-01GQP Terms and Definitions

7.4.2-02F Supplier Internal Transfer Risk Assessment Tool
	 
	III.	 	RESPONSIBILITIES






	 	A.	 	Supplier Quality or equivalent is responsible for the following:






	 	1.	 	Act as the focal point for all generated SCN’s; Supplier
or GEMS generated.
	 
	 	2.	 	Assure SCN clarity, correct change categorization, and provide initial
technical screening
upon receipt.
	 
	 	3.	 	Utilize the SCN Support Central process (SCN number assigned by Support Central).
	 
	 	4.	 	Drive the completion of SCN’s via interface with
modality point of contact.
	 
	 	5.	 	Close the SCN upon completion.
	 
	 	6.	 	Notify Supplier of SCN decision (Accept/Reject).
	 
	 	7.	 	Ensure the master copy of the SCN is maintained in Support
Central.






	 	B.	 	Manufacturing Process Engineer or equivalent is responsible for
the following:






	 	1.	 	Provide the manufacturing quality evaluation for the proposed
change.
	 
	 	2.	 	Provide leadership in review of requested change to insure
process compatibility.
	 
	 	3.	 	Respond to the SCN request in a timely fashion.
	 
	 	4.	 	Consult with Engineering and other technical resources to
determine required action.
	 
	 	5.	 	Provide rework instruction for Manufacturing in the event of needed floor
action.
	 
	 	6.	 	Track SCN implementation at GEMS when a change requires
manufacturing action. Communicate change requirement to Production Planning.






	 	C.	 	Engineering is responsible for the following:






	 	1.	 	Provide technical evaluation of SCN requests. Consult with other modalities
or P & L’s in the event of multi-modality or P & L use to determine impact and
required action.
	 
	 	2.	 	Act as the modality point-of-contact to review and approve the eSCN
from Support Central site.
	 
	 	3.	 	Notify the Manufacturing Process Engineer (MPE) or equivalent at respective
modalities to determine the plan needed to properly analyze and
approve the SCN.
	 
	 	4.	 	Provide UL/ETL/CSA/FDA or other applicable agencies impact
information as it
related to the SCN if needed.
	 
	 	5.	 	Respond to the SCN request in a timely fashion.



 









 











	 	 	 
	 

	 	Before using this document, assure it is the latest revision.
	 

	 	See the Quality Systems Web page for current revision.
	GLOBAL SOURCING PROCEDURES

	 	http://3.231.180.180/cgi_bin/mfg/manuf/qualityprocedures
I.pl?pm=LIST

If you need assistance consult with your Mfg. Quality Representative
	          GE Medical Systems

	 	 






	 	 	 	 
	TITLE: Supplier Change Notice Control

	 		PROCEDURE NO: 7.4.2-02GQP
	 
	 		 
	OWNER: GSC EHS and Quality Compliance Manager

	 		PAGE 2 of 4
	 
	 		 
	DATE ISSUED: 5/2004

	 		DUE FOR REVIEW: 5/2006
	 	 		 







	 	6.	 	Determine if a Product Change Notice (PCN/ECR/ECO) is required, and if so,
initiate the Change Notice.






	 	D.	 	Supplier is responsible for the following:






	 	1.	 	Follow the SCN Procedure to communicate product changes to GEMS.
	 
	 	2.	 	Manage product changes from supplier sources in a similar fashion.
	 
	 	3.	 	Provide GEMS with adequate 90-day notice before implementation of changes.






	IV.	 	PROCEDURE






	 	A.	 	An SCN must be submitted for approval to GEMS for any change in the
supplier’s product or the production process, including manufacturing location
changes, that may affect the form, fit, function, reliability, serviceability,
performance, safety, interchangability, regulatory compliance or interface with GEMS
product.
	 
	 	B.	 	If the communication of the change comes from a GEMS affiliate, this
change must not be documented in the SCN process. This change needs to be
communicated to the appropriate modality responsible for the product so that
the change can be handled through the internal change control process.
	 
	 	C.	 	If the supplier is building to GEMS prints/specifications,
any changes to the supplier’s processes must be communicated to GEMS
as a Supplier Change Notice.
	 
	 	D.	 	For SCN’s related to the change in manufacturing location, the SQE or
equivalent must complete the Supplier Internal Transfer Risk Assessment Tool,
7.4.2-02F, as a guideline to decide if the transfer should be completed through the
eNPl process. Instructions on use of the tool and guidelines for scoring are located
in 7.4.2-02F.
	 
	 	E.	 	With regard to product changes, if GEMS owns the design and the supplier
is building to print/specification, a Product Change Notice (PCN/ECR/ECO) is
required to make changes. The supplier will use the SCN process to notify GEMS of
these change requests and GEMS will be able to document this request and route it
to the proper Engineering Design Owner. If the supplier owns the design, any changes to
the design and the manufacturing process are required to be communicated to GEMS
as a Supplier Change Notice.
	 
	 	F.	 	Once the SCN is determined to be needed, the supplier must
communicate all required information to GEMS Sourcing Point of Contact (SCN
Incoming Admin) a minimum of 90 days prior to the implementation of the change.
The required information is noted by a red asterisk in the Support
Central form
but must include the following items:






	 	1.	 	All required supplier contact information per Support Central form.
	 
	 	2.	 	GEMS part number(s) affected by the change.
	 
	 	3.	 	Modality impacted by the change.
	 
	 	4.	 	Desired cut-in date.
	 
	 	5.	 	Is the part being transferred to another location.
	 
	 	6.	 	Problem description followed by questions related to part use.
	 
	 	7.	 	Description of the solution/change.




 









 











	 	 	 
	 

	 	Before using this document, assure it is the latest revision.
	 

	 	See the Quality Systems Web page for current revision.
	GLOBAL SOURCING PROCEDURES

	 	http://3.231.180.180/cgi_bin/mfg/manuf/qualityprocedures
I.pl?pm=LIST

If you need assistance consult with your Mfg. Quality Representative
	          GE Medical Systems

	 	 






	 	 	 	 
	TITLE: Supplier Change Notice Control

	 		PROCEDURE NO: 7.4.2-02GQP
	 
	 		 
	OWNER: GSC EHS and Quality Compliance Manager

	 		PAGE 3 of 4
	 
	 		 
	DATE ISSUED: 5/2004

	 		DUE FOR REVIEW: 5/2006







	 	G.	 	The GEMS Sourcing Point of Contact will assign the appropriate SQE or equivalent to
the SCN based on the Purchased Family of the affected part.
	 
	 	H.	 	The responsible Supplier Quality Engineer (SQE) or equivalent will ensure that the
SCN form is properly and accurately filled out.






	 	1.	 	If the part is being transferred to another location, the SQE or equivalent
must answer all of the questions related to location in the form to determine if an
eNPI project must be initiated.
	 
	 	2.	 	Based on the Problem Description and the Solution/Change, the SQE or equivalent must
ensure that the questions related to part function and regulatory concerns have
been addressed.
	 
	 	3.	 	Once this information is accurate, the SQE or equivalent can approve the SCN
completely if the SCN is deemed to have no known impact to GEMS product.
	 
	 	4.	 	If the SCN is suspected to have an impact on GEMS product, the SQE or
equivalent will select the route option and the SCN will move through the
predetermined workflow.






	 	I.	 	The Global Sourcing Leader (GSL), assigned in the workflow by the Purchased Family
designation, will check the SCN for cost impact and will assign the Modality Point of
Contact for the next workflow step.
	 
	 	J.	 	The Modality Point of Contact will review the part information and assign the
Engineering Design Owner for the next step in the workflow. The Modality Point of Contact
is also responsible tor expediting the SCN through the EDO process.
	 
	 	K.	 	The Engineering Design Owner will coordinate the change with all of the other
appropriate functions to ensure that the change impact will be properly reviewed,
evaluated and approved.






	 	1.	 	If the change is determined to have no impact on
GEMS product, the SCN will be approved and routed to the Sourcing Point
of Contact for closure.
	 
	 	2.	 	If the change needs more information, such as samples, description of
problem or clarification of solution, the SCN will be updated with the
requests for information and routed back to the Sourcing Point of Contact.
This request will be routed to the requestor/supplier for
the requested information.






	 	a.	 	When the required information has
been gathered, the requestor/supplier will approve/forward the
SCN to the Sourcing Point of Contact.
	 
	 	b.	 	The Sourcing Point of Contact will
execute the workflow as per Step G above.






	 	3.	 	If the change is rejected, the SCN will be routed back to
the Sourcing Point of Contact for communication and closure to the
supplier as rejected.






	 	L.	 	The SCN documentation including any attachment will be stored in Support Central
for the life of the product as defined by GEMS.






	V.	 	COUNSEL
	 
	 	 	Sourcing Regulatory Leader




 









 











	 	 	 
	 

	 	Before using this document, assure it is the latest revision.
	 

	 	See the Quality Systems Web page for current revision.
	GLOBAL SOURCING PROCEDURES

	 	http://3.231.180.180/cgi_bin/mfg/manuf/qualityprocedures
I.pl?pm=LIST

If you need assistance consult with your Mfg. Quality Representative.
	          GE
Medical Systems

	 	 






	 	 	 
	 
	 TITLE: Supplier Change Notice Control

	 	 PROCEDURE NO: 7.4.2-02GQP
	 
	 	 
	 OWNER: GSC EHS and Quality Compliance Manager

	 	 PAGE 4 of 4
	 
	 	 
	 DATE ISSUED: 5/2004

	 	 DUE FOR REVIEW: 5/2006
	 






REVISION HISTORY




	 	 	 	 	 	 	 	 	 	 	 
	Issue	 	 	 	 	 	 
	Date	 	AUTHOR	 	APPROVAL	 	REASON FOR CHANGE
	 	 	NAME	 	DATE	 	SIGNATURE	 	DATE	 	 
	10/03

	 	K. Adam
	 	10/03
	 	B. Hulse
	 	10/03
	 	New Procedure
	 
	5/04

	 	K. Adam
	 	5/04
	 	B. Hulse
	 	5/04
	 	Revised procedure
to add the use of
the eSCN Support
Central tool and
the use of the Transfer
Risk Assessment form.






 









 






Attachment H

Repair Information and Service Packaging





 









 






	 	 	 	 	 
	GEMS Europe

	 	 	 	EPO15R1
	 

	 	TEST, PACKAGING and	 	 
	 

	 	MARKING PROCEDURE	 	 
	 

	 	FOR SERVICE PARTS
	 	Revision 5
	 
	Global Parts Europe

	 	 	 	Date : Oct 2002






REVISION HISTORY






	 	 	 	 	 
	Revision	 	Date	 	Reason for change
	 
	0

	 	April 2nd 1993
	 	Initial release of PGR 15.1
	1

	 	October 8 1993
	 	Modification of pages 2,4,5,6 of the PGR 1.5.1
	2

	 	December 1994
	 	Renumbering
	3

	 	January 1996
	 	Modification page 3: addition of quality label
	4

	 	December 1996
	 	Update
	5

	 	Oct 2002
	 	Redefine Packaging Guidelines and Quality Seal
	 





TABLE OF CONTENTS




	 	 	 	 	 	 	 
	1.

	 	PURPOSE OF PROCEDURE
	 	 	2	 
	2.

	 	SCOPE
	 	 	2	 
	3.

	 	TEST SPECIFICATIONS
	 	 	2	 
	4.

	 	GENERAL PACKAGING SPECIFICATIONS
	 	 	2	 
	5.

	 	CATEGORIES OF PACKAGING
	 	 	3	 
	6.

	 	PACKAGE IDENTIFICATION
	 	 	4	 
	7.

	 	QUALITY SEAL
	 	 	4	 
	8.

	 	PACKING LIST
	 	 	4	 
	9.

	 	USE OF GE LOGO
	 	 	4	 
	APPENDIX 1   CIRCUIT BOARD PACKAGING GUIDELINES	 	 	5	 
	APPENDIX 2   EXAMPLES OF PACKAGING	 	 	6	 
	APPENDIX 3   LABELS USED	 	 	7	 
	APPENDIX 4   HOW TO SEAL A PACKAGING	 	 	8	 






	 	 	 
	Owner:

	 	R. Lebret
	Function:

	 	Quality Leader
	 
	 	 
	Approved by:

	 	P. Vinet
	Function:

	 	Repair Operation and Development, Manager






Before
using this document, check that you have the latest revision.

This document is proprietary to GE Medical Systems.





Page 1/8














 







	 	 	 	 	 
	GEMS Europe

	 	 	 	EPO15R1
	 

	 	TEST, PACKAGING and	 	 
	 

	 	MARKING PROCEDURE	 	 
	 

	 	FOR SERVICE PARTS
	 	Revision 5
	 
	Global Parts Europe

	 	 	 	Date : Oct 2002









	1.	 	PURPOSE OF PROCEDURE
	 
	 	 	This procedure is to:
	 
	 	 	Define test, packaging and marking rules for service parts delivered by European suppliers
when no other specific document is associated to a part.
	 
	 	 	Reference documents
	 
	 	 	GEMS Global Packaging Guideline recommendations # 2155696PRE (available on
www.gegsn .com)
	 
	2.	 	SCOPE
	 
	 	 	This procedure applies to all service parts supplied to Service, both new
and repaired parts when no other specific document is associated with the
parts. This includes such items as electronic boards, HV supplies, power supplies, cables,
components, and consumable and repairable accessories, without any restriction.
	 
	3.	 	TEST SPECIFICATIONS
	 
	 	 	Every part must be verified according to the characteristics provided by the
manufacturer. Every part must be functionally verified according to current state of
the art practices.
	 
	4.	 	GENERAL PACKAGING SPECIFICATIONS




	 	a.	 	Parts shall be individually packaged, even for small parts excep when specific
instructions refer to a kit.
	 
	 	b.	 	Size of Package shall be adapted to the size of the part: as small as possible, while
maintaining adequate protection.
	 
	 	c.	 	Weight restrictions — Units over 25 kg shall be banded to a pallet and they shall have special
handling hazards marked on the outside, using international symbols.
	 
	 	d.	 	Hazardous materials shall be handled in the following manner: Package, mark, label and document
any material or product that is regulated as hazardous
	 
	 	e.	 	Packages shall provide basic protection from moisture, crushing, paint scuffing, corrosion,
temperature and other product specific needs as required.





Before using this document, check that you have the latest revision.

This document is proprietary to GE Medical Systems.




Page 2/8
















 








	 	 	 	 	 
	GEMS Europe

	 	 	 	EPO15R1
	 

	 	TEST, PACKAGING and	 	 
	 

	 	MARKING PROCEDURE	 	 
	 

	 	FOR SERVICE PARTS
	 	Revision 5
	 
	Global Parts Europe

	 	 	 	Date : Oct 2002






 




	 	f.	 	Repairable parts : Repairable parts must be wrapped in packages which
facilitate their
return to repair centers. The packaging must be replaced after each repair to
obtain a
clean package ready for the next shipment except if the package is considered as a
Reusable package (see next paragraph).
	 
	 	g.	 	Reusable packaging: Reusable package may be used for expensive packaging.
The main
and expensive parts of the package can be reusable. This can be achieved easily by
using
a low-cost, replaceable external case. The external packaging must be replaced
after
each delivery to obtain a clean package ready for the next
shipment.
	 
	 	h.	 	Protection from static electricity : All electronic boards and
parts containing sensitive, accessible components must be protected from damage
due to electrostatic discharge (ESD). ESD sensitive parts shall be wrapped in a
conductive antistatic bag or film. The bag must be closed using a tamper-proof
label (see Appendix 2 & 3). See Appendix 1 for detailed instructions about ESD.





	5.	 	CATAGORIES OF PACKAGING
	 
	 	 	The following categories were created to give examples of the minimum necessary
requirements. Components may still need specially designed packaging to be able to meet
the testing standards.






	 	a.	 	Electronic Components (circuit boards, etc)

ESD bag with ESD foam individually boxed. The component shall fit snug in the
box. Foam
must be on all sides of the box.

See Appendix 1 for specific guidelines
	 
	 	b.	 	Cables

Individually packaged in a bag with connectors bubble wrapped. The bags shall
be labelled.
	 
	 	c.	 	Mechanical/Plastic components 

Individually boxed and packaged in bubble wrap and/or foam.
	 
	 	d.	 	Batteries

Shall be treated as a hazardous material and shall meet all government
regulations unless otherwise stated as exempt.
	 
	 	e.	 	Power Supplies/Transformers 

Flexible foam shall be used to protect the units. Double cardboard shall be
used.
	 
	 	f.	 	Pressurized Cans

Shall be treated as a hazardous material and shall meet all government
regulations, unless otherwise stated as exempt.
	 
	 	g.	 	Oversized items

See specification 2155696PRE.





Before using this document, check that you have the latest revision.

This document is proprietary to GE Medical Systems.






Page 3/8














 









	 	 	 	 	 
	GEMS Europe

	 	 	 	EPO15R1
	 

	 	TEST, PACKAGING and	 	 
	 

	 	MARKING PROCEDURE	 	 
	 

	 	FOR SERVICE PARTS
	 	Revision 5
	 
	Global Parts Europe

	 	 	 	Date : Oct 2002






 




	 	h.	 	Computers/monitors

Packaged with foam inserts in a corrugated container with access holes.
	 
	 	i.	 	Kits 

Packaged in a bag. The bags must be labelled.





	6.	 	PACKAGE IDENTIFICATION (SEE APPENDIX 3) 
	 	 	 
	 	 	
All individual packages must be labelled with a label that specifies the following:






	 	Ø	 	 GEMS Part Number
	 
	 	Ø	 	 Part Description
	 
	 	Ø	 	 Bar Code encoding Part Number
	 
	 	Ø	 	Supplier name
	 
	 	Ø	 	 Country of Origin
	 
	 	Ø 	 	Purchase Order or Repair Order
	 
	 	Ø	 	 Serial Number if required by GELS






	 	 	The medium to be used shall be white adhesive labels with printing black ink. The
size of the characters printed on the label must be greater than
6mm.
	 
	 	 	Labels must be placed in a visible location where they are protected from being turn off
during handling.
	 
	7.	 	QUALITY SEAL (SEE APPENDIX 3)
	 
	 	 	Quality Seal is used as a seal of quality and placed on the external packaging (see
Appendix 4). Quality Seals must be placed on all entry points (generally up and down).
This assures the recipient that the package has not been opened in transit. However,
should the package be opened to allow a check, the operator will have to repack and reseal
the package with a properly filled up label identifying the warehouse.
	 
	8.	 	PACKING LIST
	 
	 	 	Packing List For “Service Parts” :

Include a packing list that identifies the GEMS Part Number, PO
number or Repair
order number and quantities all of the materials included with the shipment. Any
documentation needed to receive the part at the distribution facility
must be on the
outside of the package so opening is not required.
	 
	9.	 	USE OF GE LOGO
	 
	 	 	Use the GE logo on supplier packages only when specifically stated in the purchase
order package. When used, specific guidelines must be followed for placement and size of
all logo graphics. Specific layout instructions and artwork are available through GEMS on
request.





Before using this document, check, that you have the latest revision.

This document is proprietary to GE Medical Systems.




 


Page 4/8














 








	 	 	 	 	 
	GEMS Europe

	 	 	 	EPO15R1
	 

	 	TEST, PACKAGING and	 	 
	 

	 	MARKING PROCEDURE	 	 
	 

	 	FOR SERVICE PARTS
	 	Revisions 5
	 
	Global Parts Europe

	 	 	 	Date : Oct 2002






APPENDIX 1




CIRCUIT BOARDS PACKAGING GUIDELINES





Electronic boards are packaged individually.




The packaging comprises two parts:




§
 Sealed conductive antistatic bag ensuring protection of the board from electrostatic
discharge (ESD).




§
 Sealed cardboard box, with markings to identify its contents, to ensure mechanical protection
of the board.




Antistatic bag




Only conductive antistatic bags made of a multiple-layer film of polyethylene, polyester, and
nickel are authorized. These bags are transparent, so that the board can be identified without
opening the bag.




The bag must be used to return repairable boards to the repair center.




The bag must be closed using a tamper-proof label (see Appendix 2 & 3).

This provides a
guarantee that a true faraday cage has been created around the board which is thus protected
against static electricity and a means of determining whether or not the board has been removed
from its protective envelop.




Cardboard box




The
cardboard box has two parts :


Ÿ
Pre-printed cardboard case accommodating the marking labels





Ÿ Pre-folded cardboard sheet, coated with shock-absorbing foam




Note: It is recommended that the foam should be easy to separate from the cardboard to
satisfy packaging recycling requirements.




External dimensions of the package shall be at least 30 mm greater than those of the part packaged.

The package must however, hold the part firmly.

The case is preferably pre-printed

The package carries the mandatory marking labels described in Appendix 3.




Closure of the cardboard box must provide a guarantee to the user against all risk of opening. The
closure shall be ensured by a flexible crimped tape, and a quality seel (see Appendix 3) shall enable
the user to check that the package has not been opened.




It
is requested that antistatic bag be sealed. The name of the repair or manufacturing centre
technician in charge of the final test, and the test date must be indicated either on the board
or on the antistatic bag label.




The cardboard box used to delivery parts to the Global Parts must be clean and free of
handwritten markings or labels other than that indicating the part number, the board origin and
the quality seal. This is essential to prevent errors of identification or distribution. Package
is sealed to eliminate all handling risks.



Before using this document, check that you have the latest revision.

This document is proprietary to GE Medical Systems.





Page 5/8









 












 









 















 









 














 









 








Attachment I



Purchased Material Quality Requirements




Signed
on December 1st, 2005 (attached)




 









 








			
	Before using this document, assure
it is the latest revision.
	 	7.4.2-01F-GQP
	See eLibrary DOC0079550 for current revision.
	 	Revision: 01
	 
	 	Due for Review: 10/2007






GE Healthcare Minimum Purchased Material Quality Requirements




Supplier
Name: Volcano Corporation




Supplier
Businesses/Location(S): Rancho Cordova CA USA, 

__________________________________________________


__________________________________________________
_________________________________________________
_



Section I — Quality Items: The Supplier is responsible to meet or exceed the
part requirements and specifications as referenced in the Purchase Order or Purchase
Agreement with GE Healthcare (“Agreement”). The measurement of defects for each Supplier
by part may be calculated periodically and either reported directly to a Supplier or
available on request. Upon request from GE Healthcare, the Supplier shall provide
documented plans and/or procedures for rework, repair, and testing of
defective returns.



Upon request from GE Healthcare, the Supplier shall provide documented corrective action
plans to prevent future deviations from the specification. The Supplier shall have a
total of thirty (30) days from receiving a corrective action request from GE Healthcare
to submit formal documentation to address the non-conformance and provide details of the
corrective action.



Section II — Engineering Specifications Section: The Supplier is responsible to ensure
that delivered items meet the requirements of the revisions and/or versions specified on
the applicable Agreement. A complete listing of required documents and revision levels
for each physical identifier is available in the GE Healthcare Global Product Structure
(bill of material). This will be provided to the Supplier by GE Healthcare. The Supplier
is responsible to resolve discrepancies between this list and the documentation in their
possession before items are manufactured. For GE Healthcare designed Products, the
Supplier is responsible to assure that both they and their Sub-Suppliers use GE
Healthcare engineering documentation which are maintained in
compliance with all accepted
Engineering Change Requests/Engineering Change Orders issued by GE Healthcare.



Upon request from GE Healthcare, the Supplier shall ensure that part qualification is
conducted and documents are submitted as required. The part qualification requirements
shall be determined by GE Healthcare and shall consist of a minimum of a part layout
plan, capability study, and a process control plan.



Section III
— Compliance: Where applicable, the Supplier shall maintain compliance to
industry standards and product listings such as UL, CSA, IEC etc., for all Products
delivered to GE Healthcare. Where applicable, Supplier shall also maintain compliance to
EU directives and their member state transpositions, specifically EU Directive 2002/95/EC
(RoHS Directive) and 2002/96/EC (WEEE Directive) as amended. Additionally, the Supplier
shall maintain. compliance with any and all laws and government regulations that apply in
the manufacturing and delivery of its products, including reporting, record keeping and
production testing applicable to the manufacture of medical devices, radiation emitting
devices and electromagnetic compatibility for all products delivered
to GE Healthcare. Such laws may include, but are not limited to, United States and foreign medical device
laws, regulations and directives, labor laws, environmental laws, Custom Trade
Partnership Against Terrorism (CTPAT) regulation and product safety laws. The Supplier
shall provide GE Healthcare all information necessary to enable GE Healthcare to comply
with the laws and regulations applicable to the GE Healthcare sale and use of GE
Healthcare products.




Page 1 of 3






 









 








			
	Before using this document, assure it is the latest revision.
	 	7.4.2-01F-GQP
	See eLibrary DOC0079550 for current revision.
	 	Revisions: 01
	 
	 	Due for Review: 10/2007






GE Healthcare Minimum Purchased Material Quality Requirements



If ElectroStatic Discharge (ESD) sensitive devices are
supplied to GE Healthcare, the Supplier must have an active ESD
program and use proper ESD handling and packaging procedures.
Applicable components include circuit boards, electronic assemblies
with exposed components or connectors, semi-conductors and any other
devices that may require ESD protection. Suppliers must maintain
records of the testing done and training provided.



Section IV — Change Notification: Changes proposed by Supplier, both
material and process changes, which may affect form, fit, function,
reliability, serviceability, performance, functional
interchangeability, regulatory compliance, safety, options or spare
parts interchangeability or interface capability with GE Healthcare
Product must be submitted along with a written change notice, for GE
Healthcare approval. This includes, but is not limited to, changes
of sources of material and parts, changes in manufacturing
processes, test procedures, manufacturing locations, relocation or
replacement of equipment and any similar changes that are
anticipated by Sub-Suppliers. Items affected by such changes may not
be delivered to GE Healthcare until the Supplier has received
written approval for the changes from GE Healthcare. At minimum, the
change notice must include the Supplier’s affected part number, date
of implementation, serial number effectivity of the assembly that is
changed, reason for the change, specific details of the change and
supporting data that demonstrates that part reliability has not been
impacted negatively. The change must not be implemented without
prior written consent from GE Healthcare, which shall not be
unreasonably withheld. In addition, GE Healthcare has the right to
request samples for evaluation by GE Healthcare.



Section V —  Packaging and Shipping Methods: The Supplier shall
provide packaging and shipping methods to prevent cosmetic,
mechanical and electrical damage to the Product. A packing list
showing purchase order number, part number, revision number, total
number of articles/boxes shipped, date of shipment and quantity must
be affixed to the outside of the container. The Supplier shall meet
or exceed the detailed specifications of the GE Healthcare packaging
requirements found in the Supplier Packaging Guidelines, document
number 2134821PRE, and the Global Packaging Guidelines for
International Shipments, document number 2100268PRE.



Section VI
— Quality Record Retention: The Supplier shall maintain
clear, clean and accurate records of results of acceptance
activities for each Product delivered to GE Healthcare. These
records shall include the test/inspection criteria, revision level
of documents/equipment/software used, activities performed
(planning, routing or traveler sheets), dates of test/inspection,
results and identification of the individual(s) conducting the
activities. Where applicable, these records shall include a list of
the equipment used for test/inspection. The Supplier shall store
all records pertaining to the Product until GE Healthcare notifies
the Supplier that the product life has ended and/or GE Healthcare
requests the records.



Section VII — Quality and Safety Reporting: The Supplier shall
maintain a documented reporting system to GE Healthcare when the
Supplier has knowledge of any product issue related to safety or
quality that results in stopping shipment or requires a recall. Any
actions taken by the Supplier to report a recall to a regulated
agency must be communicated to GE Healthcare immediately (within 24
hours). GE Healthcare has the right to request Supplier to provide
all documents regarding the specific issue including the analysis,
root cause and corrective action taken to minimize any risk to GE
Healthcare customers.




Page 2 of 3





 










 






	 	 	 
	Before
using this document, assure it is the latest revision.

	 	7.4.2-01F-GQP
	See
eLibrary DOC0079550 for current revision.

	 	Revision: 01
	 

	 	Due for Review: 10/2007






GE Healthcare Minimum Purchased Material Quality Requirements



Section IIX
— Quality Systems: The Supplier shall maintain a documented quality system that
encompasses the following areas: how quality documents are generated and controlled, how
manufacturing processes are controlled, how special or automated processes are validated, how
suppliers are controlled, how test equipment is calibrated and controlled, handling of defective
material, how corrective action processes are controlled, and how process control is implemented.
The ISO 9001:2000 Standard, ISO 13485:2003 Standard and the FDA Quality System Regulation (Code of
Federal Regulations 21CFR Part 820) should be referenced as examples of Quality System structure
and discipline. GE Healthcare may audit the Supplier’s quality system at periodic intervals upon written
advance notification. GE Healthcare may also request periodic, joint quality assurance
meetings at the Supplier’s facility to update the Status of product quality and reliability.



Section IX — Documentation: The Supplier shall ensure that all GE Healthcare documentation is
controlled and distributed with the correct revision level to the appropriate personnel that
produce the product for GE Healthcare. The Supplier shall also ensure that all GE Healthcare
documentation is treated as proprietary and confidential. The Supplier shall be responsible for
ensuring that all applicable GE Healthcare documentation is provided to all of the Supplier’s
Sub-Suppliers involved in the supply of product for GE Healthcare.



Section X — Order of Precedence: This document shall be an addendum to any Purchase Agreement or
existing Purchase Orders between Supplier and GE Healthcare. Any conflict between this document
and a Purchase Agreement regarding the minimum material quality requirements shall be resolved
pursuant to the terms of the Purchase Agreement. Any conflict between this document and the Purchase
Order regarding the minimum material quality requirements shall be resolved pursuant to the terms
of this document.



Agreed
to and Accepted by Supplier




	 	 	 	 	 
	Signature:

Printed Name:

	 	/s/ David Tucker
 

David Tucker
	 	 
	 
	Title:

	 	Director of Quality Assurance	 	 
	 
	Date:

	 	December 1, 2005	 	 
	 
	Supplier Name:

	 	Volcano Corporation	 	 
	 
	Agreed to and Accepted by GE Healthcare	 	 
	 
	Signature:

	 	/s/ Jean Louis Baudet	 	 
	 

	 	 	 	 
	 
	Printed Name:

	 	Jean Louis Baudet	 	 
	 
	Title:

	 	Global Modality Sourcing Leader Ies.	 	 
	 
	Date: 	 	December 1, 2005	 	 







Page 3 of 3










 










Attachment J

Initial Orders for Pilots




	 	 	 	 	 	 	 	 	 	 	 
	Item	 	Qty	 	Description	 	Delivery Date	 	Total USD
	1

	 	 	1	 	 	s5i Pilot #1
	 	April 1, 2006
	 	USD [CONFIDENTIAL]
	2

	 	 	1	 	 	s5i Pilot #2
	 	April 7, 2006
	 	USD [CONFIDENTIAL]
	3

	 	 	1	 	 	s5i Pilot #3
	 	April 7, 2006
	 	USD [CONFIDENTIAL]
	4

	 	 	1	 	 	s5i Pilot #4
	 	April 7, 2006
	 	USD [CONFIDENTIAL]
	5

	 	 	1	 	 	s5i/GE Pilot #1
	 	May 1, 2006
	 	USD [CONFIDENTIAL]
	6

	 	 	1	 	 	s5i/GE Pilot #2
	 	May 1, 2006
	 	USD [CONFIDENTIAL]
	7

	 	 	1	 	 	s5i/GE Pilot #3
	 	May 1, 2006
	 	USD [CONFIDENTIAL]
	8

	 	 	1	 	 	s5i/GE Pilot #4
	 	May 1, 2006
	 	USD [CONFIDENTIAL]
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8	 	 	 	 	 	 	USD [CONFIDENTIAL]





Terms and conditions subject to the Agreement GEMS / VC Agreement # 06-OEM-VC-EV-JLB




 









 











Attachment M

Countries of the Territory that Currently Maintain Exclusive Distribution

Agreements with Volcano



Argentina, Australia, Brazil, Bulgaria, Canada, Columbia, Cyprus, Czech Republic, Finland, Greece,
Hong Kong, Iceland, India, Indonesia, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Malaysia,
Mexico, New Zealand, China (North), Pakistan, Phillipines, Poland, Portugal, Puerto Rico, Romania,
Russia, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, Turkey,
U.A.E, Venezuela




 









 








Attachment N

EU Language Policy




 









 








	GLB CPF1037-001-EMEA Language Requirements	 	Page 1 of 11








EMEA Language Requirements




DEFINITIONS





	 	1.	 	EMEA: Europe, Middle East, Africa,
	 	 
	 	2.	 	Labeling: All written, printed or graphic matter on a medical device
or any of its containers or wrappers accompanying a medical device and
relating to its identification, technical description and use.

	 	 
	 	 	 	
This
excludes shipping documentation and promotional material.


	 	 
	 	 	 	


 This
excludes such information necessary for configuration, installation
and service which must be performed by trained and English speaking
staff
	 	 
	 	3.	 	Label: All written, printed or graphic matter upon the device or
immediate containers or wrappers necessary for the safe use of the
device
	 	 
	 	4.	 	Secondary Language/Flexibility: The possibility of an exemption of
mandatory countryspecific language requirements in order to use
another language.
	 	 
	 	5.	 	GUI = Graphical User Interface: Any textual information visible to the
end user e.g. patient and end user specific on-screen information or
context menue or on-screen help, print outs, keyboards etc.

	 	 
	 	 	 	
This
excludes such information necessary for configuration, installation
and service which must be performed by trained and English speaking
staff.
	 	 
	 	6.	 	Device Evaluation = Milestone: External Evaluation within NPI process.
The purpose of the evaluation is to obtain customer’s feedback about
the functions and features of the medical equipment. The medical
equipment used for this customer evaluation shall be CE marked and
thus demonstrates that the used medical product complies with the
relevant Essential Requirements of the MDD 93/42/EEC. This is NOT
Clinical Investigation or Clinical Evaluation.
	 	 
	 	 	 	TBD = Not started or pending investigation into potential legal
exemptions





INFORMATION IN THIS DOCUMENT WAS VERIFIED BY LAWYERS, LOCAL

COMPETENT AUTHORITIES OR LOCAL QRS PERSONNEL





 










 







	 	 	 
	GLB CPF1037-001 EMEA Language Requirements

	 	Page 2 of 11






European Union/EFTA




	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	Secondary
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Languages or known
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	Flexibility
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Austria

	 	German
	 	German
	 	German
	 	German
	 	TBD
	 	none
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Belgium

	 	Dutch + French

+ German must be

provided
	 	Dutch + French

+ German must be

provided
	 	Dutch + French

+ German must be

provided
	 	Dutch + French

+ German must be

provided
	 	English
	 	The legal
requirement under
Belgian law (Royal
Decree of 18 March
1999) is that :



- for patients, the
three national
languages must be
used;
	 

	 	 	 	 	 	 	 	 	 	 	 	- for professional
users, the national
language of the
professional must
be used.
	 

	 	 	 	 	 	 	 	 	 	 	 	Exceptions to the
latter are possible
if the following
conditions are met:
	 

	 	 	 	 	 	 	 	 	 	 	 	- a written
agreement is
concluded between
the professional
user and the
manufacturer, his
agent or authorised
representative, mentioning the
reasons why the
national language
cannot be used;
	 

	 	 	 	 	 	 	 	 	 	 	 	- the agreement
does not violate
the national laws
on the protection
of employees
	 

	 	 	 	 	 	 	 	 	 	 	 	- the agreement
must be signed by
the parties and
kept at the
disposal of the
authorities.
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Cyprus

	 	English
	 	English
	 	English
	 	English
	 	English	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Czech

Republic

	 	Czech
	 	Czech for
Safety instructions
and user
instructions
	 	Czech
	 	Czech
	 	TBD
	 	none
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Denmark

	 	Danish
	 	Danish
	 	Danish
	 	Danish
	 	Danish
	 	none






 









 






	 	 	 
	GLB CPF1037-001 EMEA Language Requirements

	 	Page 3 of 11






	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	Secondary
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Languages or known
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	Flexibility
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Estonia

	 	Estonian
	 	Estonian or English
	 	Estonian
	 	Estonian
	 	TBD
	 	Only English GUI
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Finland

	 	Finnish AND
Swedish;
English only if
information is not
safety-related
	 	Finnish AND
Swedish;
English only if
information is not
safety-related
	 	Finnish AND

Swedish
	 	Finnish AND
Swedish; English
only if information
is not safety-related
	 	English
	 	English only for information which is not
relevant to ensure the safe use of the device
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	France

	 	French
	 	French, except all
Installation and
Configuration
Guides solely used
by software
installers or
administrators. It
has to be sure that
medical personnel
operating the
hardware on which
such software is
installed will NOT
use this software.
	 	French
	 	French
	 	French
	 	none
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Germany

	 	German
	 	German
	 	German
	 	German
	 	English
	 	Exception possible “in justified cases”, but:
	 

	 	 	 	 	 	 	 	 	 	 	 	- The language used must be easily understandable
to the user or
	 

	 	 	 	 	 	 	 	 	 	 	 	- Other measures must guarantee
that the useris







 










 









			
	 	 	 
	     GLB
CPF1037-001 EMEA Language Requirements
	 	Page 4 of 11
	 	 	 





	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Secondary Languages or
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	known Flexibility
	 

	 	 	 	 	 	 	 	 	 	 	 	      -appropriately instructed. And:

	 

	 	 	 	 	 	 	 	 	 	 	 	     
All information relating to aspects of safety
must be available in German or in the language
of the user (if non-German) 

	 	 	 
	Greece

	 	Greek/MoH
may
exclude devices
designated
exclusively for
professional use
from Greek
language: in this
case English is
mandatory
	 	English
	 	Greek
	 	Greek
	 	English
	 	Only English GUI
	 	 	 
	Hungary

	 	Hungarian
	 	Hungarian;
English only if
all terms are
explained in the
manual
	 	Hungarian
	 	Hungarian
	 	TBD
	 	Only English GUI if all terms are explained in the
Hungarian manual
	 	 	 
	Iceland

	 	Icelandic
	 	Icelandic
	 	Icelandic
	 	Icelandic
	 	TBD
	 	other languages for professional use
	 	 	 
	Ireland

	 	English
	 	English
	 	English
	 	English
	 	English
	 	none
	 	 	 
	Italy

	 	Italian
	 	Italian
	 	Italian
	 	Italian (no
instructions are
needed for medical
devices Class I or
IIa if they can be used safely without
such instructions
	 	Italian
	 	none
	 	 	 
	Latvia

	 	Latvian
	 	Latvian or English
	 	Latvian
	 	Latvian
	 	TBD
	 	Only English GUI






 









 









			
	 	 	 
	     GLB
CPF1037-001 EMEA Language Requirements
	 	Page 5 of 11
	 	 	 





	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Secondary Languages or
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	known Flexibility
	Liechtenstein

	 	German
	 	German
	 	German
	 	German
	 	TBD
	 	none
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	Lithuania

	 	Lithuanian
	 	Lithuanian or

English
	 	Lithuanian
	 	Lithuanian
	 	TBD
	 	Only English GUI
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	Luxembourg

	 	French +

German must be

provided
	 	French +

German must be

provided
	 	French + German

must be provided
	 	French + German
must be provided
	 	When the
device is
intended for the
exclusive use by
professionals
the labelling and
wording may be
in English
	 	none
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	Malta

	 	Maltese or

English
	 	Maltese or

English
	 	Maltese or

English
	 	Maltese or English
	 	English
	 	English
	 

	 	 	 	 	 	 	 	 	 	 	 	 
	Netherlands

	 	Dutch
	 	Dutch
	 	Dutch
	 	Dutch
	 	English if the
user is a
professional and
trained
	 	Exception possible on case-by-case basis by the
Ministry of Health; main criteria:
• Special training on the use of the medical device

• Use of the device only by specialists

• Use of the device on a regular basis to acquire
routine (min. two or three times a week)

	 

	 	 	 	 	 	 	 	 	 	 	 	 
	Norway

	 	Norwegian
	 	Norwegian
	 	Norwegian
	 	Norwegian
	 	English if the
	 	For electro-medical equipment:
	 

	 	 	 	 	 	 	 	 	 	user is a
professional and
trained
	 	The use of an alternative language on
electro-medical equipment is possible.


Applications for a waiver must be sent to:
Direktoratet for samfunnssikkerhet og
beredskap — Enhet for elektriske produkter
Postboks 2014
	 

	 	 	 	 	 	 	 	 	 	 	 	3103 Tønsberg






 









 









			
	 	 	 
	     GLB
CPF1037-001 EMEA Language Requirements
	 	Page 6 of 11
	 	 	 





	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Secondary Languages or
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	known Flexibility
	 

	 	 	 	 	 	 	 	 	 	 	 	No special instructions exist to submit an
application-Just write a rationale
explaining the reason/s why we deliver
the equipment with English. The
professional users of the equipment must
be fluent enough in the alternative
language. The Competent Authority will ask
for more relevant information if required.



For non-electrical-medical equipment: English for
professional use
	 	 	 
	Poland

	 	Polish
	 	Polish or
English if
displayed
information is
explained in +
referred to the
Polish manual
AND staff is
trained
	 	Polish
	 	Polish
	 	TBD
	 	Only English GUI
	 	 	 
	Portugal

	 	Portugese
	 	English with

Portugese

translation in an

attached

document
	 	Portugese
	 	Portugese
	 	Portugese
	 	Local law does not know exceptions; but
negotiations with the authorities are recommended
by local lawyer
	 	 	 
	Spain

	 	Spanish
	 	Spanish
	 	Spanish
	 	Spanish
	 	TBD
	 	None — but it is worth negotiating with the
competent authorities
	 	 	 
	Slovakia

	 	Slovakian
	 	Slovakian or English
	 	Slovakian
	 	Slovakian
	 	TBD
	 	Only English GUI
	 	 	 
	Slovenia

	 	Slovenia or

English
	 	Slovenia or

English
	 	Slovenia or

English
	 	Slovenia or English
	 	Slovenia or

English
	 	Only medical devices which are intended by the
manufacturer to be used exclusively by professional






 









 









			
	 	 	 
	     GLB CPF1037-001 EMEA Language Requirements
	 	Page 7 of 11
	 	 	 





	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Secondary Languages or
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	known Flexibility
	 

	 	 	 	 	 	 	 	 	 	 	 	medical staff may be in English.
	 	 	 
	Sweden

	 	Swedish
	 	Swedish
	 	Swedish
	 	Swedish
	 	See: Flexibility
	 	Exemptions are only granted in a limited sense i.e. in
individual cases, to protect the health of a person. An
exemption is only granted on a temporarily basis.
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	Medical Products Agency and National Board of Health
and Welfare jointly review applications for exemption
from the rules and regulations governing Medical
Devices. (cf. LVFS 2001:5, 6§ pt.12 concerning Active
Implants; LVFS 2001:7, 6§ pt.12 concerning IVD
Devices or LVFS 2003:11, 4§ pt. 3 and 7§ pt. 12,
respectively, concerning general Medical Devices) 


The following information should be included in the application:
	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 	1)State which requirement/’s in the regulations exemption
is applied for
	 

	 	 	 	 	 	 	 	 	 	 	 	2) Specify the full designation/denomination of the
product
	 

	 	 	 	 	 	 	 	 	 	 	 	3) Describe the product and state its intended purpose
	 

	 	 	 	 	 	 	 	 	 	 	 	4) State why the product, despite divergences from the
regulations, can be used safely for patient and users
(give an account for the results from a structured risk
analysis)
	 

	 	 	 	 	 	 	 	 	 	 	 	5) State which period of time exemption is applied for
and when the instructions for use in Swedish will be
available
	 

	 	 	 	 	 	 	 	 	 	 	 	6) State the number of product units applied for
	 

	 	 	 	 	 	 	 	 	 	 	 	7) State to whom the product will be delivered
	 

	 	 	 	 	 	 	 	 	 	 	 	8) State why the product is indispensable
	 

	 	 	 	 	 	 	 	 	 	 	 	9) Describe measures taken to find an approved
alternative product
	 

	 	 	 	 	 	 	 	 	 	 	 	10) State what will happen with the product when

exemption period expires
	 

	 	 	 	 	 	 	 	 	 	 	 	11) Assurance (on the need) from Head of Dept if other
than applicant







 









 






     



			
	GLB CPF1037-001 EMEA Language Requirements
	 	Page 8 of 11






	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	Operator’s	 	Device	 	Secondary Languages or
	Country	 	Labels	 	Interface	 	Information	 	Manual	 	Evaluation	 	known Flexibility
	 

	 	 	 	 	 	 	 	 	 	 	 	Note that
the Manufacturer/Distributor and the Care
Provider both have to file an application
Applications may be submitted either separately or as a
joint document. Points1-7 are primarily of concern to
Manufacturers/Distributors, 8-11 to Care Providers.
Send applications to Medical Products Agency, Medical devices, P.O. Box 26, SE-751 03
UPPSALA, Sweden
	 
	Switzerland

	 	French +

German +

Italian must be provided
	 	French +

German + Italian

must be provided
	 	French + German

+ Italian must be

provided
	 	French + German +

Italian must be

provided
	 	English: signed
agreement with
customer. It shall be ensured
that customer
understands
English
	 	According to article 7 of the Swiss Regulation on
Medical Devices
(www.admin.ch/ch/d/sr/819 124/a7.html
) any product information in the frame of the
European Directive must be given in the three
national languages, i.e. German, French and Italian.
However, the competent Federal authority
(Fachstelle Medizinprodukte, Bundesverwaltung
Bern, Mr. Zobrist, Fax +41 31322 76 46) may make
exceptions if (i) safety of patients, users and third
parties is protected and (ii) compliance with the
language requirements would cause a
disproportionate effort.
	 
	United

Kingdom

	 	English
	 	English
	 	English
	 	English
	 	English
	 	N/A






 









 





     



			
	 	 	Page 9 of 11






Europe
excluding European Union/EFTA


[GLB CPF1037-001 EMEA Language Requirements]



	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety–related	 	Operator’s	 	Device	 	Secondary Languages or
	Country	 	Labels	 	Interface	 	Informations	 	Manual	 	Evaluation	 	known flexibility
	Albania

	 	Albanian or English
	 	Albanian or English
	 	Albanian or English
	 	Albanian or English
	 	 	 	English.
	 
	Azerbeidjan

	 	Russian or English
	 	Russian or English
	 	Russian or English
	 	Russian or English
	 	 	 	English
	 
	Belarus

	 	Russian or English
	 	Russian or English
	 	Russian or English
	 	Russian or English
	 	 	 	English
	 
	Bosnia–Herzegovina

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Bulgaria

	 	Bulgarian or English
	 	Bulgarian or English
	 	Bulgarian or English
	 	Bulgarian or English
	 	 	 	English
	 
	Croatia

	 	Croatian or English
	 	Croatian or English
	 	Croatian or English
	 	Croatian or English
	 	 	 	English
	 
	Kasachstan

	 	Russian or English
	 	Russian or English
	 	Russian or English
	 	Russian or English
	 	 	 	English
	 
	Kyrgisia

	 	Russian or English
	 	Russian or
English
	 	Russian or
English
	 	Russian or English
	 	 	 	English
	 
	Macedonia

	 	Serbian or
English
	 	Serbian or
English
	 	Serbian or English
	 	Serbian or English
	 	 	 	English
	 
	Moldavia

	 	Russian or
English
	 	Russian or
English
	 	Russian or
English
	 	Russian or English
	 	 	 	English
	 
	Romania

	 	Romanian for
all info
necessary for
the safe use
	 	Romanian or
English
	 	Romanian for all
information
necessary for the
safe use
	 	Romanian for all
information
necessary for the
safe use
	 	 	 	Only English GUI
	 
	Russia (CIS)

	 	Russian
	 	Russian or
English
	 	Russian
	 	Russian
	 	 	 	Only English GUI
	 
	Tadjikistan

	 	Russian or
English
	 	Russian or
English
	 	Russian or
English
	 	Russian of English
	 	 	 	English
	 
	Turkmenistan

	 	Russian or
English
	 	Russian or
English
	 	Russian or
English
	 	Russian or English
	 	 	 	English
	 
	Ukraine

	 	Russian or
English
	 	Russian or
English
	 	Russian or
English
	 	Russian or English
	 	 	 	English
	 
	Uzbekistan

	 	Russian of
English
	 	Russian or
English
	 	Russian or
English
	 	Russian or English
	 	 	 	English
	 
	[ILLEGIBLE]

	 	[ILLEGIBLE]
	 	[ILLEGIBLE]
	 	[ILLEGIBLE]
	 	[ILLEGIBLE]
	 	 	 	[ILLEGIBLE]






 









 





     



			
	GLB CPF1037-001 EMEA Language Requirements
	 	Page 10 of 11






Middle East + Africa




	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	 	 	Device	 	 
	Country	 	Labels	 	Interface	 	Informations	 	Operator’s Manual	 	Evaluation	 	Secondary Language
	Egypt

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Bahrain

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Iran

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Israel

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Jordan

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Kuwait

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Lebanon

	 	French
	 	French
	 	French
	 	French
	 	 	 	English
	 
	Oman

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Palestine

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Pakistan

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Quatar

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Saudi Arabia

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Syria

	 	English
	 	English
	 	English
	 	English
	 	 	 	English
	 
	Turkey

	 	English
	 	English
	 	English
	 	Turkish
	 	 	 	Only English GUI
	 
	United Arab Emirates

	 	English
	 	English
	 	English
	 	English
	 	 	 	English






 









 





     



			
	GLB CPF1037-001 EMEA Language Requirements
	 	Page 11 of 11






	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Graphical User	 	Safety related	 	 	 	Device	 	 
	Country	 	Labels	 	Interface	 	Informations	 	Operator’s Manual	 	Evaluation	 	Secondary Language
	Algeria

	 	French
	 	French
	 	French
	 	French
	 	 	 	French
	 
	Ivory Coast

	 	French
	 	French
	 	French
	 	French
	 	 	 	French
	 
	Morocco

	 	French
	 	French
	 	French
	 	French
	 	 	 	French
	 
	Senegal

	 	French
	 	French
	 	French
	 	French
	 	 	 	French
	 
	South Africa

	 	English
	 	English
	 	English
	 	English
	 	 	 	French
	 
	Tunesia

	 	French
	 	French
	 	French
	 	French
	 	 	 	French