Document:

exv10w23

 

EXHIBIT
10.23

MICRUS ENDOVASCULAR CORPORATION

and

BIOTRONIK AG

LICENSE, DEVELOPMENT

and

DISTRIBUTION AGREEMENT

As of January 6, 2006

**Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	 	 	 	 	Page
	 
	 	 	 	 
	1.
	 	DEFINITIONS	 	1
	 
	 	 	 	 
	2.
	 	DEVELOPMENT; STEERING COMMITTEE	 	6
	 
	 	 	 	 
	3.
	 	LICENSE GRANTS	 	9
	 
	 	 	 	 
	4.
	 	RESEARCH PAYMENTS AND COSTS	 	10
	 
	 	 	 	 
	5.
	 	LICENSE FEES; ROYALTY PAYMENTS	 	11
	 
	 	 	 	 
	6.
	 	ROYALTY REPORTS, PAYMENTS AND ACCOUNTING	 	12
	 
	 	 	 	 
	7.
	 	MANUFACTURING; SUPPLY AND DISTRIBUTION	 	13
	 
	 	 	 	 
	8.
	 	FORECASTS, PURCHASE ORDERS, ORDER ACCEPTANCE	 	15
	 
	 	 	 	 
	9.
	 	DELIVERY, LATE DELIVERY, SHIPMENT DESTINATION, ACCEPTANCE	 	16
	 
	 	 	 	 
	10.
	 	PRICES, PAYMENT TERMS	 	17
	 
	 	 	 	 
	11.
	 	PRODUCT CHANGES	 	17
	 
	 	 	 	 
	12.
	 	WARRANTIES, REPRESENTATIONS AND COVENANTS	 	18
	 
	 	 	 	 
	13.
	 	INDEMNIFICATION	 	19
	 
	 	 	 	 
	14.
	 	TERM AND TERMINATION	 	21
	 
	 	 	 	 
	15.
	 	ASSURANCE OF SUPPLY	 	21
	 
	 	 	 	 
	16.
	 	REGULATORY AFFAIRS	 	22
	 
	 	 	 	 
	17.
	 	QUALITY MANAGEMENT	 	23
	 
	 	 	 	 
	18.
	 	LIMITED WARRANTY	 	23
	 
	 	 	 	 
	19.
	 	REPORTING, PRODUCT ANALYSIS, VIGILANCE, REMEDIAL ACTION	 	25
	 
	 	 	 	 
	20.
	 	LICENSED PATENTS	 	26
	 
	 	 	 	 
	21.
	 	CONFIDENTIALITY; PUBLICATIONS	 	27
	 
	 	 	 	 
	22.
	 	MISCELLANEOUS	 	27

-i-

 

 

LICENSE, DEVELOPMENT

AND

DISTRIBUTION AGREEMENT

     This LICENSE, DEVELOPMENT AND DISTRIBUTION AGREEMENT (together with the attachments and
exhibits hereto, the “Agreement”) is entered into as of January 6, 2006 (the “Effective
Date”) by and between Micrus Endovascular Corporation, a corporation established under the laws
of Delaware and having its principal place of business at 610 Palomar Avenue, Sunnyvale, CA 94085,
USA (“Micrus”); and Biotronik AG, a Swiss corporation having a principal place of business at
Ackerstrasse 6, CH-8180 Bülach, Switzerland (“Biotronik”).

RECITALS

     WHEREAS, Biotronik solely owns or controls intellectual property rights in certain technology
related to vascular interventional devices;

     WHEREAS, Biotronik is a leading manufacturer and distributor of interventional cardiology
devices and has developed proprietary technology for stents and delivery systems;

     WHEREAS, Micrus desires to obtain from Biotronik an exclusive license for neurovascular use
and a co-exclusive license for carotid stent products under all of Biotronik’s intellectual
property, and Biotronik desires to grant Micrus such licenses;

     WHEREAS, Micrus wishes to develop, manufacture, sterilise and label products for neurovascular
intervention in humans and to sell the developed products;

     WHEREAS, Biotronik wishes to be appointed as contract developer and supplier for such
developed products, which includes development according to the product specification of Micrus,
manufacturing, sterilisation and labelling of the products.

     NOW, THEREFORE, for and in consideration of the mutual observance of the covenants hereinafter
set forth and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties hereto agree as follows:

1. DEFINITIONS.

     1.1 All references to particular Exhibits, Articles and Sections shall mean the Exhibits to,
and Articles and Sections of, this Agreement, unless otherwise specified. References to this
“Agreement” include the Exhibits. For the purposes of this Agreement, the following words
and phrases shall have the following meanings:

     1.2 “Affiliate” of an entity means, for so long as one of the following relationships
is maintained, any corporation or other business entity owned by, owning, or under common ownership
with a party to this Agreement to the extent of at least fifty percent (50%) of the equity (or such
lesser percentage that is the maximum allowed to be

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owned by a foreign corporation in a particular jurisdiction) having the power to vote on or
direct the affairs of the entity and any person, firm, partnership, corporation, or other entity
actually controlled by, controlling or under common control with a party to this Agreement.

     1.3 “AMS” means absorbable metal stents and the related technology.

     1.4 “Calendar Quarter” shall mean a period, with respect to the first Calendar Quarter
only, starting on the Effective Date and ending March 31, 2006, and then each successive period of
three (3) consecutive calendar months ending June 30, September 30 December 31, or March 31 of the
following year.

     1.5 “Claim” means a complaint or proceeding filed or initiated against a party hereto
by a Third Tarty alleging damage to, or infringement of the rights of, such third party or an
affiliate or predecessor in interest of such Third Party, or any complaint or proceeding of a
government agency alleging violation of any law.

     1.6 “Confidential Information” shall mean all written information and data provided by
one Party to the other hereunder and marked “Confidential” or a reasonable equivalent thereof or,
if disclosed orally, visually or in some other form, is summarized in writing, is identified as
“Confidential” and is provided to the other Party within thirty (30) days of such disclosure,
except any portion thereof which:

          (a) is known to the recipient, as evidenced by its written records, before receipt thereof
under this Agreement;

          (b) is disclosed to the recipient without restriction after acceptance of this Agreement by a
Third Party who has the right to make such disclosure;

          (c) is or becomes part of the public domain through no breach of this or any other Agreement;
or

          (d) is independently developed, as evidenced by its written records, by or for the recipient
by individuals or entities without use of or reference to the information disclosed to the
recipient by the disclosing Party hereunder.

     All non-public information concerning neurovascular use developed during the course of work
performed under this Agreement shall be deemed to be the Confidential Information of Micrus ,
unless specified otherwise in the applicable written Statement of Work. All non-public information
concerning coronary or distal use developed during the course of work performed under this
Agreement shall be deemed to be the Confidential Information of Biotronik , unless specified
otherwise in the applicable written Statement of Work.

     1.7 “Contract Year” shall mean a period, with respect to the first Contract Year only,
starting on the Effective Date and ending on March 31, 2007 and then each successive period of
twelve (12) consecutive calendar months commencing on April 1 and ending on March 31 of the
following year.

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     1.8 “Deliverables” shall mean all tangible items to be delivered by Biotronik to
Micrus as specified in a Statement of Work which will be developed pursuant to this Agreement and
shall be deemed to include, but not be limited to, written descriptions, manuals, data-sheets,
drawings, photographs, models, prototypes, tapes, disks, masks and circuitry.

     1.9 “Developed Product” shall mean any device, component and composition developed
during the course of a project under this Agreement. The Products which the Parties have already
agreed to develop (subject, with respect to each such Product, to the execution of a Statement of
Work) are listed and specified in Exhibit A which is attached to this Agreement, and may be
revised from time to time by the mutual written agreement of the Parties. Developed Product and
Product may be used interchangeably herein.

     1.10 “Development Steering Committee” shall have the meaning set forth in Section 2.6.

     1.11 “FTE” shall mean a minimum of forty (40) hours per week for individual Biotronik
scientific employees assigned to perform a project under a particular Statement of Work, or its
equivalent if a given employee is assigned on a part-time basis and therefore multiple employees
are added to provide a single FTE.

     1.12 “Fully Burdened Manufacturing Cost” shall mean the cumulative cost of a Product
and shall include the direct and indirect cost of procuring and/or producing the Product in
accordance with generally accepted accounting principles applied on a consistent basis by
Biotronik. Direct costs shall include direct labor (including fringe benefits), direct materials
(including taxes and duties) and third-party contract and licensing costs required to manufacture
the Product, as well as all costs related to the approval process. Indirect costs (to be allocated
to the production effort) shall include, but not be limited to, items treated as ‘manufacturing
overhead,’ such as indirect labor and materials, reasonable fringe benefits, occupancy costs,
depreciation of property, plant and equipment used in the manufacturing process and other costs
reasonably allocable to the manufacturing process, to the extent that the foregoing are directly
related to the production effort. For purposes of this Agreement, unless otherwise stated in the
applicable Statement of Work, indirect costs shall be deemed to equal 40% of direct costs.
Included in the cost of Product shall be manufacturing variances, including inventory reserves and
non-conforming production runs. The Fully Burdened Manufacturing Costs for each Product shall be
as set forth in the applicable Statement of Work.

     1.13 “GAAP” or “U.S. generally accepted accounting principles” shall mean the
conventions, rules and procedures governing accounting practices as established, and revised or
amended, by the U.S. Financial Accounting Standards Board or the U.S. Securities and Exchange
Commission.

     1.14 “Know-How” shall mean all unpatented Confidential Information of Biotronik, technical
information, materials and know-how owned and/or controlled by Biotronik now and/or during the
Term, which relates to Licensed Patents or any Product and shall

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include, without limitation, all chemical, pharmacological, toxicological, clinical, assay, control
and manufacturing data and any other information, biological materials or related technology
relating to any Product and that can reasonably be deemed to be useful or essential for the
development and commercialization of any Licensed Product and strains, samples, analytical tools,
etc.

     1.15 “Licensed Patents” shall mean (i) the patents and patent applications listed in
Exhibit B; (ii) any international and foreign counterparts thereof; (iii) any divisionals,
continuations, continuations-in-part, refilings, and extensions of any of the foregoing patents and
patent applications (iii) all substitutions, reissues, renewals, reexaminations, patents of
addition, and inventors certificates thereof; and (iv) all patents issuing from or claiming a
priority date from any of the foregoing (which shall be deemed to have been added to Exhibit B);
any Patents of Biotronik or its affiliates added to Exhibit B from time to time (which shall
include any Patents covering Licensed Technology as identified by either Party from time to time).

     1.16 “Licensed Technology” shall mean (i) the Licensed Patents; (ii) the Product Know-How;
(iii) Proprietary Rights; (iv) Technical Information; (v) the design of the product, inventions,
analytical reference materials in or related to the Licensed Patents or any of the products listed
on Exhibit A; and (vi) any other technology that Biotronik or its Affiliates may from time to time
own, develop or license (for any period reasonably licenseable) from a Third Partiy during the
Term, to the extent such technology has potential neurovascular applications, including without
limitation balloon catheters, stents (including AMS) and stent delivery systems.

     1.17 “Minimum Purchase Orders” shall mean either the yearly or the quarterly
minimum purchase amounts as agreed upon in the applicable Statement of Work, which will be reviewed
at least once a year and shall be adapted to Biotronik  ́s reasonable expectations in Micrus  ́
reasonably commercializing each Product.

     1.18 “Net Sales” shall mean the gross amount received by Micrus or an Affiliate of
Micrus for the sale or other disposition to a Third Party of a Product, less the following
deductions for amounts actually incurred related to such sale or other disposition and included in
the gross invoiced amount: (a) normal, customary sales commissions, customary credits and
customary rebates and customary allowances and customary adjustments for rejections, recalls or
returns (in the case of commissions to employees or Affiliates of Micrus the commission shall be
deductible up to [***] % of the net price per product only); (b) freight, insurance; (c) sales,
use, excise, value-added and similar taxes or duties imposed on the sale.

     1.19 “Party” shall mean either Micus or Biotronik, and “Parties” shall mean both
Micrus and Biotronik.

“Product” shall mean a Developed Product that both (a) has been accepted by Micrus under
Section 2.13; (b) is approved for sale and distribution by all applicable regulatory bodies and (c)
the manufacture, use, sale, offer for sale or importation of which, but for

***Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.

4

 

the license granted hereunder, would infringe one or more Valid Claims of Licensed Patents.
Product and Developed Product may be used interchangeably herein.

     1.20 “Proprietary Rights” shall mean any and all inventions disclosed, described or
claimed in the Licensed Patents,

          (a) any and all trade secrets and Technical Information relating to the Developed Product;

          (b) any and all copyrights relating to or covering the Developed Product or Technical
Information; and

          (c) all other intellectual property of any type under the laws of any country throughout the
world relating to or covering the Developed Product, methods of manufacture, methods of use, and
any other novel invention the practice of which is necessary to exploit the Developed Product.

     1.21 “Product Specifications” shall mean any and all requirements of the Developed
Products, including but not limited to technical, physical, chemical, environmental, labelling,
packaging and supplementary requirements described in the product specifications and applicable
Statement of Work.

     1.22 “Statement of Work” shall have the meaning given in Section 2.2.

     1.23 “Technical Information” shall mean any technical data or information relating to
the Product, including, without limitation, know-how, data, skill, expertise, experience, models,
drawings, materials, records, any and all preclinical and clinical studies including safety and
efficacy data, procedures of testing and quality control requirements or any part or combination
thereof, necessary to market the Product.

     1.24 “Term” shall have the meaning set forth in Section 14.1.

     1.25 “Third Party” shall mean a natural person, corporation, partnership, trust, joint
venture, governmental authority or other legal entity or organization other than the Parties and/or
their Affiliates.

     1.26 “Valid Claim” shall mean, with respect to each country, a claim of an issued,
unexpired patent included in the Licensed Patents or the Joint Research Program Patents, that has
not been (a) held invalid or unenforceable by a final court or governmental agency of competent
jurisdiction or pursuant to binding arbitration, or (b) admitted in writing to be invalid or
unenforceable by the holder(s) by reissue, disclaimer or otherwise. Unless (a) or (b) applies, an
issued patent is considered to be unexpired for a period of twelve years from the date of signing
of this agreement on. Micrus agrees not to challenge any of Biotronik  ́s patents or Licensed
Patents.

     1.30
“Warranty Period” shall mean the time period commencing upon shipment of a Product
to Micrus or its designee and ending on the Product expiration date as indicated on the Product
label.

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     1.31 Interpretive Rules. For purposes of this Agreement, except as otherwise
expressly provided herein or unless the context otherwise requires: (a) defined terms include the
plural as well as the singular (and vice versa) and the use of any gender shall be deemed to
include the other gender; (b) references to “Articles,” “Sections” and other
subdivisions and to “Schedules” and “Exhibits” without reference to a document, are
to designated Articles, Sections and other subdivisions of, and to Schedules and Exhibits to, this
Agreement; (c) unless otherwise set forth herein, the use of the term “including” means
“including but not limited to”; and (d) the words “herein,” “hereof,”
“hereunder” and other words of similar import refer to this Agreement as a whole and not to
any particular provision.

2. DEVELOPMENT; STEERING COMMITTEE.

     2.1 Collaboration. The parties shall collaborate in the development of Developed Products for
neurovascular applications. The parties agree that the end goal of the research programs shall be
the creation of Products. No material deviation in the subject matter, scope and development
schedule of such research and development program shall be made without the mutual written
agreement of both parties.

     2.2
Scope of Project. Biotronik and Micrus are concurrently executing the Statement of Work
attached hereto as Exhibit C. Biotronik and Micrus may from time to time enter into
separate statements of work for other development projects (each of which, a “Statement of Work”),
as the parties mutually agree and each such Statement of Work shall be governed by this Agreement.
Biotronik agrees to perform the development work described in each Statement of Work and to develop
and test Developed Products meeting the technical specifications set forth in the applicable
Statement of Work.

     2.3 Development Schedule. A timeline and schedule, including the major product milestones and
target dates with respect to one or more Product(s), shall be described in each Statement of Work.
The parties agree that the development schedule set forth shall be a reasonable schedule for the
development work to be performed, and each party will put forth commercially reasonable efforts to
comply with the timelines. Once signed by authorized representatives of both parties a Statement
of Work shall become part of this Agreement.

     2.4 Development Responsibilities. Subject to the terms and conditions contained in this
Agreement, Biotronik hereby agrees to use reasonable efforts to develop and obtain regulatory
approval in the European Union (CE-Mark) and in the United States for manufacture and supply the
Developed Products conforming to the Product Specifications in sufficient quantity (to meet demand
therefore (i.e. at least [***]% of the Minimum Purchase Order amount for such Product). Biotronik
will use reasonable efforts to perform development, clinical and regulatory approval activities in
accordance with the applicable Project Schedule.

     2.5 Diligence in Development. Biotronik will use reasonable efforts consistent with effort
used in Biotronik’s own priority research and development program

***Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.

6

 

to conduct the research under and in accordance with the development program as described in
each Statement of Work.

     2.6 Establishment and General Responsibilities of the Development Steering Committee. A
Development Steering Committee (the “Development Steering Committee”) shall be established within
thirty (30) days after the Effective Date of this Agreement. The Development Steering Committee
shall consist of four (4) members, two (2) individuals appointed by Biotronik and two (2)
individuals appointed by Micrus, in each event identified through written notice to the other party
in accordance with this Agreement. Any member of the Development Steering Committee may designate
a substitute to attend and perform the functions of that member at any meeting of the Development
Steering Committee. The Development Steering Committee shall be responsible for review and
adoption of annual budgets for development activities and annual budgets for clinical development
activities, coordination of the supply of preclinical and clinical grade test materials, and the
monitoring and oversight of the development program and the clinical activities, provided that each
Statement of Work shall be subject to the approval of the Parties, and no change to a Statement or
Work that would affect Micrus’ funding obligations thereunder (amount or milestones) shall be made
without the approval of Micrus.

     2.7 Meetings. Meetings of the Development Steering Committee shall be held, at a minimum,
every six (6) months (or more frequently as agreed by the Development Steering Committee), and will
be held alternatively in California (such meetings to be chaired by an individual from Micrus) and
Switzerland (such meetings to be chaired by an individual from Biotronik), or at such other
location as may be determined by the Development Steering Committee, including, if applicable, by
telephone. A quorum of the Development Steering Committee shall require the attendance of all four
(4) members or their respective designees. A final copy of the minutes of each meeting, clearly
describing any formal actions taken by the Development Steering Committee, shall be approved and
signed by a representative from each party within thirty (30) days after the meeting. Any
modifications to the development program generally, a particular Statement of Work or any clinical
program (including the work, budget and timeline therefor) formally approved at any Development
Steering Committee meeting shall be included in or attached to the minutes for such meeting. The
Development Steering Committee will operate by unanimous consent, with each party having a single
vote.

     2.8 Professional Standards. Biotronik shall make all commercially reasonable efforts to
progress the development work in a timely manner using the highest professional standards
consistent with good clinical practice and adherence to applicable laws and regulations. If
Biotronik is delayed at any time in the progress of the timelines in the Project Schedule by causes
beyond the control of Biotronik, then the timeline shall be extended by a Change Order Agreement
for such reasonable time as the parties will agree but no longer than the time period of such delay
outside their control. Agreement to such a Change Order Agreement will not be unreasonably
withheld by Biotronik. Any such changes that result in additional charges shall be reflected in
reasonable modifications to the budget and payment schedule.

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     2.9 Change Process.

          (a) During the course of performance in connection with a Statement of Work, the parties may
desire a change in scope of the anticipated effort. Requests for changes in services and all
applicable modifications in compensation must be reflected in writing by a Change Order Agreement
and expressly approved by an authorized individual on behalf of each of Biotronik and Micrus.
Notwithstanding the above, an exception will apply if a requested modification involves the safety
of a human subject, at which case Biotronik shall act on the requested change, and when
practicable, to give written notice immediately to Micrus by telephone promptly followed in
writing.

          (b) Change Orders may be approved and forwarded via hand-delivery, facsimile, electronic mail,
or overnight courier. Absent compelling reasons, Change Orders will be considered and a response
will be given within fifteen (15) days of Micrus’ or
Biotronik’s request for same.

     2.10 Expenses. Except as expressly agreed otherwise by Micrus in a Statement of Work,
Biotronik shall bear all of its own expenses arising from its performance of its obligations under
this Agreement and each Statement of Work issued hereunder, including (without limitation) expenses
for facilities, work spaces, utilities, management, clerical and reproduction services, supplies,
and the like.

     2.11 Monthly Reports. Biotronik agrees to provide to Micrus at least monthly with a written
report of the progress of the work required under each Statement of Work issued hereunder, any
anticipated problems (resolved or unresolved), and any indication of delay in fixed or tentative
schedules.

     2.12 Site Visits. Biotronik shall, from time to time and upon reasonable notice, allow
access to its premises by Micrus for purposes of design review, “walkthroughs,” and discussions
between Micrus and Biotronik management and personnel concerning the status and conduct of work
being performed under any Statement of Work issued hereunder.

     2.13 Delivery and Acceptance. Biotronik shall deliver each Deliverable called for by the
applicable Statement of Work, including prototypes and final Developed Products, upon completion,
for testing and acceptance to Micrus. Biotronik shall memorialize such delivery in a Delivery
Confirmation that sets forth the nature and condition of the Deliverables, the medium of delivery,
and the date of their delivery. Unless a different procedure for testing and acceptance is set
forth in the applicable Statement of Work, Micrus shall commence acceptance testing following its
receipt of the Deliverables at Micrus’ own facilities. Upon completion of such testing, but no
longer than after four weeks, Micrus shall issue to Biotronik a written notice of acceptance or
rejection of the Deliverables. In the event of rejection, Micrus shall give its reasons for
rejection to Biotronik in reasonable detail. Biotronik shall use reasonable commercial efforts to
correct any deficiencies or nonconformities and resubmit the rejected items as promptly as possible
until the Deliverables are accepted; provided, however, that upon the third or any subsequent
rejection or if the corrections are not

8

 

made within reasonable time to be mutually agreed upon after the initial rejection, Micrus may
terminate the Statement of Work or, at Micrus’ election, this Agreement, unless the Deliverables
are accepted during the notice period. Additionally, Micrus may, at its option, itself correct the
deficiencies or engage a third party to correct such deficiencies, and Biotronik shall provide all
reasonable assistance requested to Micrus and in such corrective actions, Micrus shall be permitted
to set-off reasonable costs incurred for such corrective actions against future payments owed to
Biotronik under this Agreement.

3. LICENSE GRANTS.

     3.1 Grant of License. Biotronik hereby grants to Micrus the exclusive (subject only to the
provisions of Section 3.2), worldwide, perpetual, irrevocable (except as expressly provided
herein) license under the Licensed Technology to develop, have developed, use, sell (directly or
through its Affiliates and distributors), offer for sale and import, manufacture, and have
manufactured Products, all of the foregoing for neurovascular applications only. For the sake of
clarity, by “neurovascular applications” the Parties mean applications to treat aneurysms or
arteriovenous malformations (AVMs) as well as other vascular conditions of the brain and the spinal
cord.

     In case any of the Confidential Information leads to a patent, Biotronik hereby undertakes to
license it free of charge to Micrus for neurovascular use, as Micrus undertakes to license it free
of charge to Biotronik for cardiovascular use.

     3.2 Exclusivity. The license will be exclusive, and Biotronik and its Affiliates shall not
sell (a) Developed Products or (b) any other products for neurovascular applications.
Additionally, Biotronik and its Affiliates shall not license or grant rights under any Licensed
Technology to any Third Party for neurovascular applications. Notwithstanding the foregoing,
Biotronik shall have the right to have manufactured and sell (directly or through its Affiliates
only) carotid stents developed by Biotronik using the Licensed Technology that are Developed
Products hereunder, for any application other than neurovascular applications, provided that
Biotronik pays half of the costs of development of such product (including clinical and regulatory
expenses) in accordance with a Statement of Work signed by the Parties with respect to such
Product.

     3.3 Clawback. If Micrus has not fulfilled a yearly Minimum Purchase Order of an approved
Product, then Biotronik shall have the right to terminate the license only with respect to such
Product by giving sixty (60) days advance written notice to Micrus, provided that Micrus may avoid
such termination by curing said default during the sixty (60) day notice period. The AMS-Neuro
license, however, will be terminated irrespective of the above mentioned requirements, if there is
no commercial product available five years after the signing of this agreement unless such failure
is due to the fault of Biotronik, and provided further that if on the fifth anniversary of the
Effective date one or more products incorporating AMS technology is in an active EU or USA
regulatory approval process, i.e. file submitted or pivotal trial ongoing, the deadline for
delivery of a commercial product shall be extended to six years from the Effective Date.

9

 

     3.4 Biotronik Exclusive Rights. Micrus agrees that, for so long as Biotronik is (a) not in
breach of its development or manufacturing obligations hereunder (b) able to meet Micrus’
reasonable requirements for development and manufacture of Products, Micrus will use Biotronik as
its sole contract developer with respect to Products and its sole manufacturer of Products. If
Micrus intends to seek a Third Party manufacturer or developer with respect to Products, Micrus
will notify Biotronik in writing at least thirty (30) days prior to the commencement of such Third
Party’s services (unless Micrus has previously notified Biotronik of a breach hereunder which
breach remains uncured), and Biotronik shall have an opportunity to cure any breach or commit to
additional services during such thirty (30) day period, subject to Micrus’ reasonable approval of
the correction or proposed services.

4. RESEARCH PAYMENTS AND COSTS.

     4.1 Development Research Funding. Research and development costs relating to Developed
Products shall be borne solely by Micrus except as expressly herein set forth or as set forth in
the applicable Statement of Work (Lekton and Lekton blue not to exceed €120.000). Each Statement of
Work shall contain an annual budget for each Developed Product and the method for calculating costs
incurred, including detailed FTE rates applicable to the project, together with any mark-up agreed
to. The Parties agree that the mark-up applicable to development costs shall be [***] percent
([***]%) unless specified otherwise in an applicable Statement of Work. To the extent Biotronik
incurs costs that are reflected in a written pre-approved budget (or if exceed the budget have been
pre-approved in writing by Micrus), Biotronik shall invoice Micrus at the end of the then-current
Calendar Quarter and Micrus shall make payment to Biotronik to reimburse such costs within 60 days
of billing.

     4.2 Reports. With each quarterly invoice under Section 4.1, Biotronik shall deliver a full
and accurate accounting of development costs (by Product) for the relevant Calendar Quarter and a
computation of the amounts payable.

     4.3 Procedures. Biotronik shall keep full and accurate accounting records of all costs in
sufficient detail to determine the amounts payable under Section 4.1. Upon reasonable notice to
Biotronik, Micrus shall have the right during normal business hours to have an independent
certified public accountant, selected by Micrus and acceptable to Biotronik, audit on a
confidential basis Biotronik’s financial records pertaining to development activities to verify the
costs payable pursuant to this Agreement; provided, however, that such audit shall not take place
more frequently than once in a Contract Year. An adjustment in payment shall be made upon
demonstration of any underpayment or overpayment. Micrus agrees to cause the independent
accountant to maintain any Biotronik financial records as Confidential Information subject to the
restrictions of Section 22.

     4.4 Cost of Audits. The fees and expenses of an audit requested by Micrus pursuant to Section
4.3 shall be borne by Micrus; provided, however, that if any audit reveals that Biotronik
overcharged Micrus under this Agreement as to the period being audited by more than five percent
(5.0%) of the amount that was payable for such period,

***Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.

10

 

then Biotronik shall, in addition to paying immediately to Micrus any such deficiency,
reimburse Micrus for the cost of such audit.

     4.5 Period to be Kept. Biotronik shall retain all books and records it is required to
maintain hereunder for the longer of: (a) five (5) years from the date of the invoice to which
they pertain; or (b) the applicable time period as required by the laws of the country in which the
cost originated.

5. LICENSE FEES; ROYALTY PAYMENTS.

     5.1 License Fees. Micrus shall make the following payments to Biotronik under this Agreement
by wire transfer of immediately available funds:

          (a) Micrus will pay Biotronik an amount of €500’000 within 5
business after the Effective Date.

          (b) Micrus will pay Biotronik an amount of €500’000 after
Biotronik has obtained CE Mark approval for stenosis application for the
Lekton Blue but no later than December 31, 2006.

          (c) Micrus will pay Biotronik an amount of €500’000 after
Biotronik has obtained CE Mark approval for scaffolding (i.e. ischemic and
aneurysm) applications for Lekton Blue, but no later than December 31, 2006.

          (d) Micrus will pay Biotronik an amount of €100’000 once the CE
Marks for stenosis application for the amber Lekton Motion Neuro has been
approved by February 28. 2006,

          (e) Micrus will pay Biotronik an amount of €100’000 once the CE
Marks for scaffolding application for amber Lekton Motion Neuro has been
approved by February 28. 2006.

     5.2 Royalties. In consideration of the worldwide license rights granted herein, Micrus shall
pay to Biotronik royalties equal to [***] percent ([***] %) of Net Sales in any country where a
Product is distributed. Micrus’ obligation to pay royalties to Biotronik under this Section 5.2
shall be imposed only once with respect to the same unit of Product, regardless of the number of
Valid Claims pertaining thereto and regardless of the number of persons and countries involved in
the manufacture, distribution and sale thereof. For the sake of clarity (and without limiting the
provisions of Section 20.1 and 20.2 below), the obligation to pay royalties with respect to a
Product shall apply so long as the Product is covered by one or more Valid Claims in either the
United States or the European Union, provided that Biotronik will use reasonable efforts to obtain
protection for any existing and new patents included in the Licensed Patents (to the extent not
time-barred as of the Effective Date) in the United States, the European Union, Japan, China,
Mexico, Argentina and Brazil.

***Certain confidential information contained in this document, marked by brackets, has been omitted
and filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.

11

 

     5.3 Terms of Payment. Within sixty (60) days following the end of each Calendar Quarter
during the Term, Micrus shall pay earned royalties based on Net Sales during the previous Calendar
Quarter. All royalty payments due to Biotronik shall be made in EUROS by wire transfer, as
directed in writing by Biotronik.

     5.4 Taxation of Royalties. Insofar as any earned royalties that are due Biotronik under this
Agreement are subject to taxation where the taxes are imposed on Biotronik, Biotronik agrees to
bear such taxes. Biotronik hereby authorizes Micrus to withhold such taxes from the payments which
are payable to Biotronik in accordance with this Agreement if Micrus is either required to do so
under the laws of any jurisdiction or directed to do so by an agency of the government of any
jurisdiction. Micrus shall furnish Biotronik with the best available evidence of payment whenever
Micrus deducts such tax from any payments due Biotronik.

     5.5 Royalty Reduction for Third Party Patents. In the event any Products sold or otherwise
distributed by Micrus or its Third Party Sublicensee(s) is covered by one or more patents owned or
controlled by a Third Party, then the Royalty in accordance with section 5.2 payable by Micrus to
Biotronik under this Agreement shall be reduced by the amount paid by Micrus to such Third Party,
provided that in no event shall the amount due to Biotronik hereunder thereby be reduced to less
than 10 % and by more than fifty percent (50%). A Royalty reduction shall not take place if Micrus
succeeds in licensing in a license from a third party at a lesser price than demanded by Biotronik.

     5.6 Royalty Term; Single Royalty. Royalties shall be earned and paid to Biotronik until the
last Valid Claim under the Licensed Patents covering the Product expires. No royalties shall be
payable on sales of Products between Micrus and any Affiliate of Micrus, provided that such
Affiliate is not an end user of such Products.

     5.7 Currency Transfer Restrictions. If in any country payment or transfer of funds out of
such country is prohibited by law or regulation, the parties hereto shall confer regarding the
terms and conditions on which Products shall be sold in such countries, including the possibility
of payment of royalties to Biotronik in local currency to a bank account in such country or the
renegotiation of royalties for such sales, and in the absence of any other agreement by the
parties, such funds payable to Micrus shall be deposited in whatever currency is allowable by
Biotronik in an accredited bank in that country that is acceptable to Biotronik.

6. ROYALTY REPORTS, PAYMENTS AND ACCOUNTING.

     6.1 Reports. With each quarterly payment made under Section 5.2, Micrus shall deliver a full
and accurate accounting of all Net Sales (by Product) for the relevant Calendar Quarter and a
computation of the aggregate earned royalties payable.

     6.2 Procedures. Micrus shall keep full and accurate accounting records of Net Sales in
sufficient detail to determine the royalties payable to Biotronik. Upon reasonable notice to
Micrus, Biotronik shall have the right during normal business hours to have an independent
certified public accountant, selected by Biotronik and acceptable

12

 

to Micrus, audit on a confidential basis Micrus’ financial records pertaining to Product to
verify the royalties payable pursuant to this Agreement; provided, however, that such audit shall
not (a) take place more frequently than once in a Contract Year, or (b) cover records for more than
the time period required for Micrus to report its taxes under the applicable country laws. An
adjustment in payment shall be made upon demonstration of any underpayment or overpayment.
Biotronik agrees to cause the independent accountant to maintain any Micrus financial records as
Confidential Information subject to the restrictions of Section 22.

     6.3
Cost of Audits. The fees and expenses of an audit requested by Biotronik pursuant to
Section 6.2 shall be borne by Biotronik; provided, however, that if any audit reveals that Micrus
underpaid the royalties due to Biotronik under this Agreement as to the period being audited by
more than five percent (5.0%) of the amount that was payable for such period, then Micrus shall, in
addition to paying immediately to Biotronik any such deficiency, reimburse Biotronik for the cost
of such audit.

     6.4
Period to be Kept. Micrus shall retain all books and records it is required to maintain
hereunder for the longer of: (a) five (5) years from the date of the royalty payment to which they
pertain; or (b) the applicable time period as required by the laws of the country in which the
royalty has been generated.

     6.5 Marketing. Upon sale of a Product, Micrus shall use commercially reasonable efforts,
consistent with its customary practices, to mark such Product (or where this is impractical, the
Product packaging) with appropriate patent numbers according to all of the relevant laws. Such
marking shall be in accordance with the requirements of the individual foreign countries, insofar
as foreign sales are concerned.

7. MANUFACTURING; SUPPLY AND DISTRIBUTION.

     7.1 Exclusive Distribution Rights. Biotronik hereby appoints Micrus, and Micrus hereby
accepts appointment, as exclusive distributor of the Developed Products for neurovascular
applications during the term of this Agreement. Accordingly, Biotronik shall not during the term
of this Agreement, supply Developed Products to any Third Party without Micrus’ prior written
consent, which may be withheld by Micrus at its sole discretion.

     7.2 Packaging and Labeling. Biotronik shall supply the Products ready for sale in accordance
with packaging and labeling instructions as specified in the Product Specification. The Product
labeling shall include the statement “Manufactured exclusively for Micrus Endovascular
Corporation” or such similar wording as is approved by Micrus, subject to the provisions of
applicable law.

     7.3 Alteration of Products, Expired Products.

          (a) Micrus shall not be allowed to alter, amend or modify the Product or any Product packaging
or labeling without prior written consent of Biotronik.

13

 

          (b) Micrus shall not sell any Products beyond their stated expiration date. Biotronik will
not take any responsibility on expired Products and therefore will not refurbish or replace expired
Products once accepted by Micrus.

     7.4 Marketing Efforts. Micrus shall have the following obligations with respect to the
marketing and distribution of the Products:

          (a) to use reasonable commercial efforts to further the promotion, marketing, and distribution
of the Products;

          (b) to provide adequate and appropriate training to its staff concerning the Products;

          (c) to use sales and technical literature as well as promotional artwork and training
materials provided by Biotronik and reasonably acceptable to Micrus. Where appropriate, Micrus may
alter such materials or develop any other materials in connection with the marketing and
distribution of Products (product brochures and sales aids), which shall be subject to Biotronik’s
prior written approval, which shall not be unreasonably withheld or delayed. Biotronik retains all
right, title and interest in materials developed by Biotronik, and Micrus retains all right, title
and interest in materials developed by Micrus.

     7.5 Trademarks. Micrus shall be the owner of and have the right to select new trademarks to
be used in connection with the Products. To the extent (if any) that Biotronik is authorized by
this Agreement to distribute Products, Biotronik shall have the right to distribute the Products
free of charge under any trademark of its own. Micrus shall have the right to use the already
existing Trademarks in Biotronik  ́s property for said Products in accordance with good customary
trademark practice, and to avoid taking any action that would in any manner impair or detract from
the value of the Trademark or the goodwill and reputation of either Biotronik. Micrus acknowledges
Biotronik’s ownership of Trademarks and related goodwill.

     7.6 Customer Service. Micrus shall provide customer service, including, but not limited to,
taking orders, responding to customer inquiries, fulfilling requests for quotes on Product pricing,
forwarding Product complaints to Biotronik on a timely basis, as legally required and providing
such assistance and information as is reasonably requested.

     7.7 Sales and Technical Literature.

          (a) Biotronik shall provide to Micrus sales, advertising and technical literature and
materials required by Micrus and shall make available copies of promotional artwork it may have
prepared. If available, Biotronik may provide the same to Micrus in electronic format.

          (b) Any adjustments or modifications of sales, advertising and technical literature to the
requirements of Micrus shall be charged to and covered by

14

 

Micrus. Said cost coverage is subject to quotation and budget approval by Micrus prior to
commencement of any adjustment or modification. Payments are limited to the approved budget and
shall be paid after acceptance of the adjustment or modification by Micrus. Biotronik shall hold
the copyright of any adjusted or modified sales, advertising and technical literature.

8. FORECASTS, PURCHASE ORDERS, ORDER ACCEPTANCE.

     8.1 Forecasts.

          (a) Micrus agrees to provide Biotronik with a 12 (twelve) months binding forecast indicating
Micrus’ intended purchases of the Products detailed to the individual variant by catalogue number
and the calendar month of forecasted purchase. Micrus agrees to reach a double digit market share
in the US and Europe for each Product.

          (b) Such forecast shall be updated by Micrus on a rolling monthly basis for each succeeding 12
(months) months period and shall be used for purposes of facilitating Micrus’ marketing plans and
permitting Biotronik and its suppliers to meet their lead times for the Products. Micrus will use
its commercially reasonable efforts to notify Biotronik promptly of any changes in its forecast.

     8.2 Purchase Order.

          (a) Micrus shall order Products by means of written Purchase Orders. The Purchase Order shall
specify applicable prices, quantities by catalogue number, shipping schedule, shipping
instructions, applicable Product Specification, any special requirements, and other similar matters
which are necessary for the individual transaction. All orders are subject to acceptance by
Biotronik, provided that Biotronik may only refuse a Purchase Order to the extent expressly
permitted by this Agreement.

          (b) The first 3 (three) months of each forecast shall be covered by a firm Purchase Order in
an amount of Products equal to such forecast for such three month period, and the quantitites to be
ordered in the firm Purchase Order for the following month shall shall not deviate form the prior
months  ́s twelve-month forecasted quantities for such month by more than minus 50 % (minus fifty
percent). Biotronik shall accept Purchase Orders calling for quantities exceeding the forecasted
quantities but may limit accepted quantities to 130 % of the most recently forecasted quantities.
Afterwards, Micrus will place Purchase Orders every month covering an additional month of supply
period.

     8.3 Order Acceptance. Biotronik shall accept or refuse in writing Micrus’ issuance of any
Purchase Order, within 5 (five) business days from the date when the order has been received and
shall not be refused without just cause. Any Purchase Order that is not rejected within the above
stated period shall be deemed accepted.

     8.4 Lead Time. Biotronik’s lead-time between cleared purchase order and product shipment is 6
(six) weeks.

15

 

     8.5 Purchase before Approval. If Micrus submits firm Purchase Orders to Biotronik before
actual regulatory approval of the Products in Europe (CE-Mark) or US (FDA-mark), and if Biotronik
accepts such orders, then if the regulatory approval of the Products as evidenced by a CE-mark or
FDA-approval is not obtained prior to or on the ordered shipment date, then without further
liability of the parties such Purchase Order shall be deemed to be completely cancelled.

     8.6 Minimum Purchase Orders. Micrus shall order the quarterly or annual Minimum Purchase Order
quantities of each Product as shown in the applicable Statement of Work.

9. DELIVERY, LATE DELIVERY, SHIPMENT DESTINATION, ACCEPTANCE

     9.1 Delivery. Biotronik commits to deliver the Products as specified in each accepted
Purchase Order to the Micrus warehouse. Biotronik will deliver Products to a common carrier
designated by Micrus on or before the date specified for such delivery on the relevant Purchase
Order. It is Micrus’ obligation to notify Biotronik of any special packaging requirements (which
shall be at Micrus sole expense). Unless otherwise agreed in writing by Biotronik and Micrus, all
deliveries of the Product shall be to FCA INCOTERMS 2000, Bülach, Switzerland.

     9.2 Late Delivery. Biotronik shall notify Micrus promptly whenever it anticipates a potential
delay in filling any of the Purchase Orders. Biotronik is allowed to make partial delivery of a
confirmed Purchase Order, provided that all additional transportation costs shall be borne by
Biotronik.

     9.3 Acceptance of the Products. Micrus shall inspect each shipment of Products and give
Biotronik written notice of any obvious defect in or damage to any Product or obvious
non-conformity with the Product Specifications or the Purchase Order within 20 (twenty) business
days as of the day of receipt of the Products. The Parties understand and agree that Products
shipped to Micrus with a use-before-period (shelf life period) of less than 18 months will not be
accepted. Without in any way limiting Biotronik’s indemnification obligations under Section 13, any
claims relating to defects or damages or non-confomity that are not
submitted to Biotronik in
writing within such period shall be deemed to be waived and released. If Biotronik disagrees with
Micrus claim that the Product delivered to Micrus is nonconforming, the Parties shall first use
good faith efforts to settle such dispute within 30
(thirty) days following Biotronik’s receipt of
notice of non-conformity under this section 9.3. If they are unable to do so within such time
period, the dispute will be resolved by a mutually acceptable independent third party laboratory,
which will analyze the allegedly non-conforming Product and determine whether such Product conforms
with the Product specifications and the Purchase Order. The Parties
agree that such laboratory’s
determination regarding conformance with the Product specification and the Purchase Order will be
final and binding. The Party against whom the third party laboratory finds shall bear the costs of
this analysis, in case of partial finding against and in favor of a party this party will bear the
costs pro rata as determined by the third party laboratory. If the Parties cannot agree

16

 

upon a third party laboratory within four weeks, such laboratory shall be determined by the
President of the Chamber of Commerce of Zurich.

     9.4 Packaging and Labelling. All Products ordered by Micrus shall be packaged for shipment and
storage in accordance with Biotronik  ́s standard commercial practices and industry standard. Micrus
shall initiate translating all user and technical manuals and advertising and marketing information
provided by Biotronik into the languages of the customers of Micrus. Any user and technical manuals
and advertising and marketing information or translation in the possession of Micrus may be used by
Biotronik free of charge in the performance of its obligations hereunder.

10. PRICES, PAYMENT TERMS.

     10.1 Prices. Pricing will be in EURO. The price for Products delivered under this Agreement
shall be equal to Biotronik’s Fully Burdened Manufacturing Costs plus [***] %. The Parties shall
meet periodically, but in no event less than twice each Contract Year, to review in detail the
calculation of Fully Burdened Manufacturing Costs, together with the relevant financial records and
other back-up used by Biotronik, and to confer and agree on the Fully Burdened Manufacturing Costs
amount that shall prevail for each Product until changed by mutual written agreement.

     10.2 Payment Terms. Biotronik shall issue an invoice for each shipment and Micrus shall make
payment of the relevant invoice within 60 (sixty) days after shipment of the Products to Micrus or
issuance of the relevant invoice, whatever occurs later. All payments will be made in Euro
currency by wire transfer to the bank account designated by Biotronik.

     10.3 Late Payment Interest. Any sums that are not paid by Micrus when due shall bear interest
at an annual rate of 5% (five percent) above EURIBOR (European Interbank Offering Rate) as
determined at the beginning of the respective calendar year.

11. PRODUCT CHANGES.

     11.1 Change of Products. Micrus may propose changes to released Product Specification. Such
changes will be reviewed by Biotronik as well as the related effect on the costs of the Product
will be determined. Changes shall be subject to Biotronik approval, which shall not be
unreasonably withheld or delayed. Biotronik will notify Micrus of acceptance of the proposed
changes and advise of any additional costs. If additional costs are involved, Biotronik must
receive written notification from Micrus of acceptance of the additional costs, before starting the
implementation of the proposed change.

     11.2 Notification of Change. Biotronik shall inform Micrus at least 2 (two) months ahead of:

          (a) any design change that changes form, fit or function of the Product,

***Certain confidential information contained in this document, marked by brackets, has been omitted and filed
with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

17

 

          (b) any clinical indication, contraindication or intended use of the Product,

          (c) any change which requires a change in the Product Specification,

          (d) any change of the actual production site or

          (e) any change of the Product or packaging which is visible by the user of the Product.

Unless Micrus agrees in writing, such changes shall be deemed to be rejected. If additional costs
are involved, Biotronik must receive written notification from Micrus of acceptance of the
additional costs.

     11.3 Required Changes caused by Remedial, Preventive or Corrective Measure. Biotronik will
bear all directly related costs (for example but not limited to: materials, labour and
transportation) associated with implementing modifications or recalling Products already delivered,
arising from remedial, preventive or corrective action measures due to design, labeling or
manufacturing.

12. WARRANTIES, REPRESENTATIONS AND COVENANTS.

     12.1 Biotronik represents and warrants to Micrus that the following statements are true:

          (a) Biotronik has the right to license the Licensed Technology as contemplated herein and to
perform its obligations hereunder;

          (b) there are no obligations of Biotronik to Third Parties that would adversely affect
Biotronik’s performance under the Agreement;

          (c) Biotronik has the right and authority to enter into this Agreement;

          (d) the Licensed Technology includes all rights necessary to develop, manufacture and sell the
Products and to have Products sold by third parties (subject to the limitations herein expressly
set forth); and

          (e) the Developed Products do not and will not infringe the intellectual property rights of a
third party in the European Union or the United States of America. This warranty is given under the
condition precedent that Biotronik has approved the product design selected and (to the extent
relevant) the Third-Party licenses used by Micrus.

     12.2 Micrus represents and warrants to Biotronik that the following statements are true:

          (a) there are no obligations of Micrus to Third Parties that would adversely affect Micrus’s
performance under the Agreement; and

18

 

          (b) Micrus has the right and authority to enter into this Agreement.

     12.3 Disclaimer. NEITHER PARTY MAKES ANY WARRANTIES, EXPRESSED OR IMPLIED, OTHER THAN THOSE
MADE HEREIN WITH RESPECT TO LICENSED TECHNOLOGY OR PRODUCTS. ALL OTHER WARRANTIES, EXPRESSED AND
IMPLIED, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE ARE HEREBY DISCLAIMED BY EACH OF BIOTRONIK AND MICRUS. This disclaimer shall not limit in
any way representations, warranties and obligations set forth in any other written agreement.

13. INDEMNIFICATION.

     13.1 Indemnification by Micrus. Micrus hereby agrees to and hereby does indemnify and hold
Biotronik harmless from and against all damages, losses, costs and expenses, including reasonable
attorneys’ fees, which Biotronik or any of its officers, directors, employees, Affiliates,
distributors or customers may incur as a result of Claims to the extent that such Claims arise out
or result from; (i) the unlawful sale or other distribution of Product by Micrus; (ii) the
negligent or willful misconduct of Micrus in the distribution, labeling or packaging of the
Product; (iii) Micrus’ use of Product in violation of this Agreement; (iv) modification of the
Product by Micrus, (v) combination of the Product with any product other than those provided or
recommended by Biotronik for use with the Product or otherwise approved by Biotronik for such use,
or (vi) breach of any representation, warranty, or obligation by Micrus hereunder, except for such
Claims which arise out of or result from the negligence or misconduct of Biotronik. Micrus shall
have sole control of any such action or settlement negotiations, and Micrus agrees to pay, subject
to the limitations hereinafter set forth, any final judgment entered against Biotronik on such
issue in any such suit or proceedings defended by Micrus. Biotronik agrees to notify Micrus
promptly in writing of any Claim and gives Micrus authority to proceed as contemplated herein, and,
at Micrus’ expense, and Biotronik agrees to give Micrus proper and full information and assistance
to settle and/or defend any such Claim. Biotronik agrees to notify Micrus promptly in writing of
such claim, suit or proceeding and gives Micrus authority to proceed as contemplated herein, and,
at Micrus’ expense, give Micrus proper and full information and assistance to settle and/or defend
any such claim, suit or proceeding, provided that Micrus shall not settle such claim, suit or
proceeding in a manner prejudicial to Biotronik without the written consent of Biotronik.

     13.2 Indemnification by Biotronik. Biotronik agrees to and hereby does indemnify and hold
Micrus harmless from and against all statutory, regulatory, common law and equitable claims
(damages, losses, costs and expenses, including reasonable attorneys’ fees), which Micrus or its
officers, directors, employees, Affiliates, distributors or customers may incur by reason of (a)
any Claim that any Product furnished to Micrus under this Agreement resulted in injury, illness, or
death of any person, to the extent that such Claims arise out of or result or are alleged to result
from (i) Product design, (ii) manufacturing or (iii) breach of any representations or warranties by
Biotronik hereunder, except to the extent such Claims arise from the negligence or willful
misconduct of

19

 

Micrus, any modification of the Product other than by or for Biotronik or any breach by Micrus
of any of its obligations, representations or warranties under this Agreement, or (b) any Claim
that a Product infringes the patent, copyright, trade secrets, trademarks or other rights of any
Third Party, provided that such claim, suit or proceeding is not based on a modification of the
Product by Micrus or a combination of the Product with any product other than those provided or
recommended or permitted by Biotronik for use with the Product. Biotronik shall have sole control
of any such action or settlement negotiations, and Biotronik agrees to pay, subject to the
limitations hereinafter set forth, any final judgment entered against Micrus or its affiliate,
distributor or customer on such issue in any such suit or proceedings indemnified hereunder by
Biotronik. Micrus agrees to notify Biotronik promptly in writing of such claim, suit or proceeding
and gives Biotronik authority to proceed as contemplated herein, and, at Biotronik’s expense, give
Biotronik proper and full information and assistance to settle and/or defend any such claim, suit
or proceeding, provided that Biotronik shall not settle such claim, suit or proceeding in a manner
prejudicial to Micrus without the written consent of Micrus. If the sale or use of a Product, or
any part thereof, is enjoined, then Biotronik shall, at its option and expense: (a) procure for
Micrus and its customers the right under such patent, trademark or other intellectual property to
make, sell and use as appropriate, the Product or such part thereof; or (b) replace the Product, or
part thereof, with other suitable Product or parts; or (c) suitably modify the Product, or part
thereof, or (d) if none of the foregoing procurement or replacement remedies is practical, refund
the aggregate payments paid by Micrus under this Agreement. Biotronik shall not be responsible
under this Section 12.2 for damages to the extent resulting from contractual commitments of Micrus
to Third Parties and not from the application of statutes, regulations, common law or general legal
principals, except to the extent Biotronik has agreed to or approved in writing such contractual
commitments.

     13.3 LIMITED LIABILITY. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT OR OTHERWISE, NEITHER
MICRUS NOR BIOTRONIK WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY
CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR (i) ANY INCIDENTAL OR
CONSEQUENTIAL DAMAGES OR LOST PROFITS OF THE OTHER PARTY OR (ii) COST OF PROCUREMENT OF SUBSTITUTE
GOODS, TECHNOLOGY OR SERVICES. NEITHER MICRUS NOR BIOTRONIK SHALL HAVE ANY LIABILITY FOR ANY
FAILURE OR DELAY DUE TO MATTERS BEYOND THE RESPECTIVE REASONABLE CONTROL OF SUCH PARTY AND ITS
AFFILIATES.

     13.4 Insurance. Each Party shall obtain and keep in force during the term iof this Agreement
and for four years thereafter a liability insurance policy in an amount not less than EUR 10
million in the aggregate (in the case of Biotronik) and U.S. $10 million in the aggregate (in the
case of Micrus), which policy shall insure against any and all claims, liabilities, costs, or
expenses resulting form or caused by (or claimed to be resulting form or caused be) the use or
operation or distribution of the Products. The insurance carrier shall be a reputable international
company reasonably acceptable by the other Party and will have an AM Best rating of no less than
A-. A copy of the

20

 

confirmation of coverage shall be given to the other Party prior to distribution of each
Product and thereafter as practical at the beginning of each new policy term.

14. TERM AND TERMINATION.

     14.1 Term. This Agreement shall commence on the Effective Date and shall be perpetual,
unless otherwise terminated earlier by operation of law or in accordance with Section 14.2 or 14.3.

     14.2 Termination for Cause. Either Party may terminate this Agreement upon written notice to
the other Party in the event the other Party (a) materially breaches this Agreement and fails to
cure such breach within sixty (60) days after receipt of written notice of breach from the
non-breaching Party (provided that a breach of Minimum Purchase Order requirements shall not be
grounds for termination hereunder but shall be subject to the provisions of Section 3.3 hereof), or
(b) makes a general assignment for the benefit of creditors, has a receiver appointed on its
behalf, or files or otherwise becomes subject to bankruptcy or insolvency proceedings which
continue unstayed and in effect for a period of sixty (60) days, or (c) does not reasonably
commercialize the products . In addition, this Agreement may be terminated with respect to any
Products with respect to which the licenses hereunder have been terminated pursuant to Section 3.3
above. All disputes concerning termination shall be resolved in accordance with Section 22.10.

     14.3 Termination Without Cause. Micrus may terminate this Agreement, without cause, on a
patent-by-patent or a product-by-product basis, or in its entirety, upon three hundred and sixty
(360) days’ prior written notice to Biotronik. Upon such termination, the respectively-terminated
license rights granted herein will cease.

     14.4 Accrued Rights and Obligations. The termination, expiration, cancellation or abandonment
of this Agreement through any means and for any reason shall not relieve the Parties of any
obligations accruing prior thereto and shall be without prejudice to the rights and remedies of
either Party with respect to the antecedent breach of any of the provisions of this Agreement.
Further, Sections 12, 13, 14, 18, 19, 20, and 21 shall survive the termination of this Agreement for
a period of five (5) years, unless otherwise expressly provided herein to the contrary. In
addition, Micrus shall retain the right after termination to distribute Products remaining in
inventory, provided that the provisions of this Agreement relating to royalties shall survive with
respect to Net Sales of any Products sold after termination hereof.

15. ASSURANCE OF SUPPLY.

     15.1 If Biotronik discontinues the manufacturing of a Product, or if Biotronik is unable to
supply the desired quantities of a Product in accordance with the provisions of this Agreement,
Micrus shall have the right, but not the obligation, to manufacture itself, or to license a Third
Party to manufacture, the Product, and Biotronik shall provide to Micrus or such Third Party
manufacturer, all information and assistance required in order to enable Micrus or the Third Party
to manufacture, including Technical Information, specialized tools and the like, provided that such
assistance may be used solely for the

21

 

purpose of fulfilling the supply obligations of Biotronik under this Agreement. Biotronik
shall notify Micrus at least 12 (twelve) months in advance of any discontinuation, and the
discontinuation shall be subject to Micrus’ written approval, for so long as Micrus has fulfilled
the Minimum Purchase Orders hereunder with respect to such Product.

     15.2 Micrus has the right of a last order which will be fulfilled by Biotronik and which shall
cover Micrus’ demand of up to 12 (twelve) months. The last order shall take into account the
quantity Micrus has ordered for the last 12 (twelve) months and the quantity Micrus has most
recently forecasted, and shall not deviate by more than thirty percent the average to the positive
or negative the average monthly quantities ordered by Micrus over the last twelve months prior to
Biotronik  ́s notice of discontinuance..

     15.3 Where possible, the Parties shall agree on a replacement of such discontinued Product and
the time schedule of the transition from the discontinued Product to a suitable replacement
product. If no such replacement product is agreed, Micrus shall have the right to terminate the
Agreement upon 30 (thirty) days written notice to Biotronik.

16. REGULATORY AFFAIRS.

     16.1 Regulatory Approval. Biotronik will obtain and maintain in its own name and at its own
expense all required regulatory approvals for sale of the Product in the United States and required
European Regulatory Approval for the Products in the European Union (CE-Mark). Biotronik shall
provide Micrus with all information Micrus reasonably requests, not including a copy of the
CE-certificate related to the Product , but any change or renewal of the same. Biotronik will
report without delay any withdrawal or expiration without renewal of any Product certificate or
approval.

     16.2 Additional Approvals. Biotronik will use best efforts to obtain regulatory approval of
the Products for any other country or region outside the European Union or the United States of
America if so requested by Micrus. Micrus shall bear the full costs for the additional approvals.
Said cost bearing is subject to quotation and budget approval by Micrus prior to commencement of
any submission preparation. Payments are limited to the approved budget and shall be done after
unconditional regulatory approval has been achieved. If legally required, Biotronik will disclose
to the regulatory authorities that Micrus is the distributor of the Products.

     16.3 Regulatory Support. Micrus or the respective sub-distributors of Micrus shall provide
Biotronik with all reasonable required support, especially in the US or Japan, to comply with any
local regulatory law and requirement including but not limited to assisting and executing all
documents necessary to satisfy all regulatory requirements in the jurisdictions in which the
Product is distributed.

     16.4 Sale or Import without Regulatory Approval. Biotronik shall not be responsible for any
sale or import of the Products into countries or regions without the national or supranational
regulatory approvals required by applicable law.

22

 

     16.5 Cooperation. Biotronik agrees to cooperate in good faith with Micrus with respect to any
regulatory approvals sought by Micrus relating in any way to Products, and to cooperate with Micrus
and any regulatory bodies in connection with any audit by any such body of either Micrus or
Biotronik. Biotronik shall bear the costs of any such cooperation or audit to the extent they
relate to Products, except to the extent (if any) arising out of a violation by Micrus of any
applicable law.

17. QUALITY MANAGEMENT.

     17.1 Quality Management System.

          (a) Biotronik will establish and maintain a quality management system in accordance with ISO
13485:2003 (“Quality Management System”). Biotronik represents and warrants that the production of
the Product takes place under the CE-certified Quality Management System.

          (b) Biotronik provides a copy of the CE-certificate concerning the approved Quality Management
System upon approval of the Product and with any renewal of the certificate. Biotronik will report
without delay any withdrawal or expiration without renewal of the legally required Quality
Management System certificate.

     17.2 Compliance Inspection. Biotronik shall inspect and test Products prior to delivery to
Micrus to ensure compliance with the Product Specifications.

     17.3 Traceability by Biotronik. In accordance with the relevant quality standards and
internal Biotronik procedures, traceability of critical or major components, processes,
manufacturing and release inspection results shall be maintained by
Biotronik or its supplier to the
individual Product identified by serial or lot number. The collected records will be archived by
Biotronik or the supplier for a period of at least one year after the expiration date of the
respective Product, but no less than the period required by United States or European Union legal
provisions, international standards or the Quality Management System of Biotronik, whatever will
result in the most extended period.

     17.4 Traceability by Micrus. In accordance with the relevant quality standards and internal
Micrus procedures, traceability of critical or major components, processes, manufacturing and
release inspection results shall be maintained by Micrus or its supplier to the individual Product
identified by serial or lot number. The collected records will be archived by Micrus or the
supplier for a period of at least one year after the expiration date of the respective Product, but
no less than the period required by United States or European Union legal provisions, international
standards or the Quality Management System of Micrus, whatever will result in the most extended
period. Micrus warrants to levy its distributors with the same obligations as contained in this
paragraph.

18. LIMITED WARRANTY.

     18.1 Warranty Period. Biotronik warrants that, for the Warranty Period each unit of Product
shall be free from defects in material and workmanship and shall conform

23

 

to the applicable Product Specification and the relevant Purchase Order. This warranty is
limited to Micrus and its Affiliates, dealers, sales representatives or agents belonging to the
Micrus sales force and may not be assigned to Third Parties.

     18.2 Warranty Conditions. The limited warranty is contingent upon proper use and storage of
the Products in accordance with Biotronik’s Instructions for Use and will not apply to Products on
which the original identification marks have been removed or altered, or to defects or failures due
to:

          (a) disaster, accident, neglect or misuse by Micrus,

          (b) failure or defect of electrical power, external electricity or circuitry, air conditioning
or humidity control, or

          (c) the use in combination with devices or accessories not provided or approved by Biotronik.

     BIOTRONIK  ́S WARRANTIES SET FORTH IN THIS SECTION AND IN SECTION 12 HEREOF ARE ITS EXCLUSIVE
WARRANTIES TO MICRUS WITH RESPECT TO PRODUCT AND ARE GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL
OTHER WARRANTIES EXPRESS OR IMPLIED CONCERNING PRODUCT; OR ANY PATENT OR PROPRIETARY RIGHTS
RELATING THERETO; AND INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.

     18.3 Notification, Replacement or Credit.

          (a) In case a defect in or a non-conformity of a Product occurs within the Warranty Period,
Micrus shall notify Biotronik in writing. Biotronik will, at no charge replace or credit any
Product which is not in conformance with the limited warranty and which is not excluded from
replacement because of violation of any warranty condition in Section 18.2 above.

          (b) Replacement of or credit for the defective or non-conforming Product in compliance with
this Section 18.3 shall be Micrus’ sole remedy with respect to any Product defect or
non-conformity.

          (c) All Products or parts thereof claimed to be defective or non-conforming with the Product
Specifications or the relevant Purchase Order must be kept at shipment destination, for inspection
by Biotronik. Micrus shall return any non-conforming or defective Products as directed by
Biotronik and at Biotronik’s expense for credit or replacement at Micrus’ discretion.

          (d) Biotronik will grant replacement or credit immediately after confirmation of the defect or
non-conformity by Biotronik but no later than 15 (fifteen) days after receipt of the defective or
non-confirming Product.

24

 

          (e) In case of replacement, Biotronik will ship the replaced Product DDP to Micrus’ designated
warehouse in accordance with INCOTERMS 2000.

19. REPORTING, PRODUCT ANALYSIS, VIGILANCE, REMEDIAL ACTION.

     19.1 Complaints. Micrus will transmit to Biotronik all oral or written complaints referring
to the Product at the time the complaints are entered into Micrus’ system.

     19.2 Safety Notification. In case a Product is suspected of deviating from the Product
Specification, or under any other circumstance where such Product might cause, or already has
caused harm to a patient, user or other person, each Party shall notify the other Party in writing
(“Safety Notification”), irrespective of the time or location of detection of the potentially
faulty Product, as soon as the respective Party gains knowledge of such. It is Biotronik’s sole
responsibility to file Medical Device Reports or Vigilance Reports to any legal authority for the
Products in order to comply with the applicable laws and regulations in the territory. Nothing in
this Agreement shall prevent Micrus from also substituting a report of any medical device incident.
Safety Notifications and any other complaints on the Products are to be effected to the following
address:

	 	 	 
	Micrus Endovascular Corporation

	 	Biotronik AG
	Attn. Medical Device Safety Officer

	 	Attn. Medical Device Safety Officer
	Street 821 Fox Lane

	 	Ackerstrasse 6
	     San Jose, California 95131

	 	     CH-8180 Bülach, Switzerland
	Tel.: +1 408 433 1400

	 	Tel.: + 41 44 864 1069
	Fax: +1 408 433 1401

	 	Fax: + 41 1 864 50 05

     19.3 Product Analysis. Biotronik is obliged to analyse free of charge any Product returned
from the field or found otherwise which is potentially non-conforming with the Product
Specifications, is malfunctioning or defective, or, might cause or already has caused harm to a
patient, a user or another person, and to report to Micrus findings, failures, actual or probable
root causes within 20 days when it becomes known to Biotronik.

     19.4 No Statement. In the event of an actual or alleged malfunction or defect of a Product,
Micrus or its representatives or agents will not make any public statement as to the cause, before
having been informed by Biotronik and having received Biotronik’s written analysis of the
malfunction or defect, and will then not render statements different from the results of such
analysis (provided that this Section 19.4 shall not prevent Micrus from reporting any information
which it is required to report in order to comply with applicable law or in the context of a legal
proceeding).

     19.5 Sales Records. Micrus will maintain complete and accurate lists and records reflecting
all Product sales and related transactions as may be required by law and

25

 

to comply with the EU regulations, regulations of the EC-Council Directive concerning medical
devices or other legal requirements applicable for a country to secure traceability of each
Product.

     19.6 Product Recall. If either Party believes that a recall of any Product is desirable or
required by law, it shall immediately notify the other Party. The Parties shall then discuss
reasonably and in good faith whether such recall is appropriate or required and the manner in which
any mutually agreed recall should be handled.

     19.7 Remedial Actions. It is Biotronik’s exclusive right and obligation to issue recalls,
safety alerts, advisory notices or similar remedial actions of the Products. In such case, Micrus
will support and fully co-operate with Biotronik to comply with the applicable laws and
regulations. Furthermore, in such case Micrus will notify its customers and, upon Biotronik’s
request retrieve identified Products. Biotronik shall bear all direct costs and expenses of any
recall, including the costs of notifying customers and costs associated with the shipment of
recalled Product from customer to Micrus or Biotronik, and replacement of such Products

20. LICENSED PATENTS.

     20.1 Prosecution. Biotronik shall take all reasonable and prudent steps to prosecute and
maintain rights under the Licensed Technology including Licensed Patents. If Micrus intends to
distribute Products in any jurisdiction where such Products are not covered by patents, Micrus may
request that Biotronik pursue patents in such jurisdiction. If Biotronik does not confirm in
writing within sixty (60) days its intention to prosecute patents in the requested jurisdiction (or
if having so confirmed it fails to expeditiously seek patent protection) then Micrus shall have the
right to file for patents in such jurisdictions, and Biotronik agrees to execute any documents or
powers of attorney reasonably necessary in order to permit Micrus to do so. Micrus shall bear the
cost of any prosecution it pursues as a result of Biotronik declining to do so, provided that
Micrus may offset its reasonable out-of-pocket expenses, including without limitation attorney’s
fees and filing fees, from royalties otherwise owing hereunder with respect to Products sold in
such jurisdiction. For the sake of clarity, nothing in this paragraph shall lead to a reduction of
Biotronik’s claim to royalties, once the above fees have been offset, and the Net Sales of the
Products shall be computed as if the patents had been applied for by Biotronik. Any patent applied
for in accordance with this paragraph is considered to be a Valid Claim, and any product
distributed, manufactured or sold with the protection of such a patent is considered to be a
Licensed Product.

     20.2 Enforcement. Micrus shall have the first right, but not the obligation, to enforce the
Licensed Technology against any Third Party infringers with respect to products and services in the
field of neurovascular applications, and to defend any claims that Licensed Products infringe the
rights of a Third Party. Biotronik shall provide all assistance reasonably requested at Micrus’
cost. Micrus shall retain any recovery obtained in any proceedings. Micrus shall not settle or
compromise any claims relating to the Licensed Technology in a manner that will prejudice
Biotronik, without Biotronik’s prior written approval.

26

 

21. CONFIDENTIALITY; PUBLICATIONS.

     21.1 Confidentiality. It is contemplated that in the course of the performance of this
Agreement each Party may disclose from time to time Confidential Information to the other Party.
Each Party agrees (a) not to use Confidential Information received from the other for any purpose
other than the performance of its obligations hereunder, and (b) not to disclose Confidential
Information so received to any Third Party, except as is necessary for such performance of this
Agreement or as is required by a court or governmental authority. In the event that such
disclosure to a Third Party becomes necessary or required (for instance, in the context of a
litigation under the provisions of an appropriately crafted protective order), the disclosing Party
shall give to the Party from whom the Confidential Information was received the greatest practical
prior written notice so as to permit the latter to take all possible action to perfect and/or
safeguard its rights in the Confidential Information, including approving the Confidential
Information to be disclosed to such Third Party. The obligations of the Parties relating to
Confidential Information shall expire five (5) years after termination of this Agreement.

     21.2 Public Announcements. Neither Party shall make any public announcement concerning the
transactions contemplated herein, or make any public statement which includes the name of the other
Party or any of its Affiliates, or otherwise use the name of the other Party or any of its
Affiliates in any public statement or document, except as may be required by law or judicial order,
without the written consent of the other Party, which consent shall not be unreasonably withheld.
Subject to any legal or judicial disclosure obligation, any such public announcement proposed by a
Party that names the other Party shall first be provided in draft to the other Party which shall
have five (5) business days to review such draft prior to the issue or publication of the
announcement.

     21.3 Safety. During the term of this Agreement, each party shall promptly inform the other
party of any information that it obtains or develops regarding the utility and safety of any
Licensed Product and shall promptly report to the other party any confirmed information of serious
or unexpected reactions or side effects related to the utilization or medical administration of
such Licensed Product.

22. MISCELLANEOUS.

     22.1 Employee Solicitation. During the term of this Agreement and for 1 (one) year after its
termination for any reason, neither Party will solicit the other Party’s employees involved in
performance of the Agreement, without prior written consent of the other Party, except that the
provisions of this sentence are not intended to apply

          (a) to any general solicitation or advertisement for employment that is not specifically
directed to the other Party’s employees or;

          (b) to efforts by an independent recruiter who is not directed to target the other Party’s
employees.

     22.2 Compliance with Laws.

27

 

          (a) Each Party shall market and distribute the Products in compliance with all applicable laws
and regulations including, without limitation, the U.S. Foreign Corrupt Practices Act of 1977, as
amended (the “FCPA”) and all applicable export laws, restrictions and regulations of any U.S. or
foreign agency or authority and not to export or re-export or allow the export or re-export of the
Product or any related technology or information in violation of any such laws, restrictions or
regulations. Each Party hereby declares that it has read and understood the provisions of the FCPA
and, on that basis, it further represents and covenants that neither it nor any of its employees or
agents have taken or will take any action to cause such party to be in violation of the FCPA.
Specifically, each party hereby certifies that it has not paid, nor offered or agreed to pay, nor
has caused to be paid, or offered or agreed to be paid, directly or indirectly, in respect of this
Agreement, any political contributions, fees or commissions to any public or governmental employee
or official anywhere for the purpose of influencing such official’s act or decision to provide
business to such Party. Each Party further certifies that it will not, directly or indirectly, in
connection with this Agreement and the business resulting therefrom, offer, pay, promise to pay, or
authorize the giving of money or anything of value to any public or governmental employee or
official, to any political party or official thereof or to any candidate for political office, or
to any person, while knowing or being aware of a high probability that all or a portion of such
money or thing of value will be offered, given or promised, directly or indirectly, to any public
or government official, to any political party or official thereof, or to any candidate to
political office, for the purpose of: (a) influencing any act or decision of such official,
political party, party official, or candidate in his or its official capacity, including a decision
to fail to perform his or its official functions; or (b) inducing such official, political party,
party official or candidate to use his or its influence with the government or instrumentality
thereof to affect or influence any act or decision of such government or instrumentality, in order
to assist Micrus or Biotronik in obtaining or retaining business for or with, or directing business
to any third party.

          (b) Each Party agrees that if subsequent developments cause the certifications and information
reported herein to be no longer accurate or complete, such Party will immediately so advise the
other Party hereto. Each Party further agrees that its violation of any part of this Section 22.2
will be a material breach of this Agreement and cause for immediate termination, without further
liability or obligation on the part of the non-breaching Party notwithstanding anything to the
contrary provided in this Agreement.

     22.3 Entire Agreement. This Agreement, together with the schedules, constitute the entire
agreement between the Parties concerning the subject matter hereof and supersede all written or
oral prior agreements or understandings with respect thereto. No other licenses other than those
enumerated herein are granted by Biotronik to Micrus.

     22.4 Amendment or Modification. Neither Party shall claim any amendment, modification or
release from any provision hereof by mutual agreement, unless in writing signed by an authorized
representative of each Party.

28

 

     22.5 Severability. If any term or provision of this Agreement shall for any reason be held
invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability
shall not affect any other term or provision hereof, and this Agreement shall be interpreted and
construed as if such term or provision, to the extent the same shall have been held to be invalid,
illegal or unenforceable, had never been contained herein.

     22.6 Assignment. Neither Party shall assign this Agreement in whole or in part without the
prior written consent of the other Party, except that Biotronik may assign this Agreement to an
Affiliate that is a corporate entity, Micrus may assign this Agreement to a successor-in-interest
in connection with a sale of assets, stock or other form or combination and its successors shall
have the right to assign this Agreement to an acquirer of substantially all of the stock or assets
of such entity (including, without limitation, an acquisition via merger transaction). Any sale or
transfer of Licensed Technology shall be made subject to this License Agreement.

     22.7 Notices.

     (a) All notices hereunder shall be in writing and shall be delivered personally, mailed by
overnight delivery, registered or certified mail, postage prepaid, mailed by a
nationally-recognized overnight courier or given by facsimile (and promptly confirmed by personal
delivery, registered or certified mail or overnight courier), to the following addresses:

	 	 	 
	If to Biotronik:

	 	Biotronik AG

Ackerstrasse 6

CH-8180 Bülach

Attn: CEO
	 
	 	 
	If to Micrus:

	 	Micrus Endovascular Corporation

610 Palomar Avenue

Sunnyvale, CA 94085

Attention: CFO

     (b) Notices shall be effective upon receipt if personally delivered, on the third business day
following the date of mailing if sent by certified or registered mail and on the second business
day following the date of delivery to the overnight courier if sent by overnight courier, or the
date of transmission if sent by facsimile. A Party may change its address listed above by notice
to the other Party.

     22.8 Force Majeure. Any delay in the performance of any of the duties or obligations of
either Party under this Agreement caused by an event outside the affected Party’s reasonable
control shall not be considered a breach of this Agreement, and the time required for performance
shall be extended for a period equal to the period of such delay. Such events shall include,
without limitation: acts of God; riots; embargoes; labor disputes, including strikes, lockouts, job
actions, or boycotts; fires; explosions; earthquakes; floods; shortages of material or energy; or
other unforeseeable causes beyond the reasonable control and without the fault or negligence of the
Party so

29

 

affected. The Party so affected shall give prompt notice to the other Party of such cause and
shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly
as possible.

     22.9 Governing Law. This Agreement shall be construed, interpreted and governed by the laws
of Switzerland, without regard to conflict of laws principles.

     22.10 Dispute Resolution. In the event of any dispute arising out of or relating to this
Agreement, the Parties shall refer such dispute to their respective Executives for attempted
resolution of the dispute by good faith negotiations within sixty days. In the event, such officers
are unable to resolve such dispute within sixty days, each Party may bring ist claim to an
arbitration panel constituted by three arbitrators, one appointed by each Party and the third
appointed by the two arbitrators, in accordance with the rules of the Schiedsgericht of the Zürcher
Handelskammer. The place of the arbitration proceeding shall be Zürich, the language of arbitration
English, and the substantive law to be applied Swiss law.

     22.11 Binding Effect. This Agreement shall be binding upon and shall inure to the benefit of
the Parties hereto and their respective assigns and successors in interest.

     22.12 Waiver. No waiver or modification of any of the terms of this Agreement shall be valid
unless in writing and signed by an authorized representative of the Parties. Failure by either
Party to enforce any rights under this Agreement shall not be construed as a waiver of such rights,
nor shall a waiver by either Party in one or more instances be construed as constituting a
continuing waiver or as a waiver in other instances.

     22.13 Schedules. All schedules that are attached to this Agreement are incorporated herein by
reference.

     22.14 Headings. The headings used in this Agreement are for convenience and reference
purposes only and shall not affect the meaning or interpretation of this Agreement.

     22.15 Counterparts. This Agreement may be executed in two (2) or more original counterparts,
each of which shall be deemed an original, but both of which together shall constitute one and the
same instrument.

30

 

     IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement to be executed by its
duly authorized officer as of the date first written above.

	 	 	 	 	 	 	 	 	 
	MICRUS ENDOVASCULAR CORPORATION	 	 	 	BIOTRONIK AG
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert A. Stern
	 	 	 	By:
	 	/s/ Martini
	 

	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Name:

	 	Robert A. Stern
	 	 	 	Name:
	 	Martini
	 

	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Title:

	 	Executive Vice President
	 	 	 	Title:
	 	CEO
	 

	 	 
	 	 	 	 	 	 

31

 

EXHIBIT A

Biotronik Product List as per November 2nd 2005

	 	 	 
	 	a) Agreed upon Products:
	 
	 	[***]
	 
	 

 

***Certain confidential information contained in this document, marked by brackets, has been omitted and filed
with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

EXHIBIT B

Biotronik Patent Group

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Category	 	 	Description	 	 	Application/Publication No	 	 	Patent No	 
	 	 	 	 	 	 	 	 	 	 	 	 
	 	[***]
	 	 	 	[***]	 	 	 	 	[***]	 	 	 	 	[***]	 	 
	 

 

***Certain confidential information contained in this document, marked by brackets, has been omitted and filed
with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

EXHIBIT C

INITIAL
STATEMENT OF WORK

 

 

Statement of Work               Micrus — Biotronik Neurovascular

 

	 	 	 	 	 
	Project name:

	 	Lekton Motion Neuro (Pharos)	 	 
	 
	 	 	 	 
	Project No.:

	 	P0249
	 	Status /Rev: 06-Jan-06/1
	 
	 	 	 	 
	Type of Project
	 	 	 	 
	 
	 	 	 	 
	X New product

	 	o Marketing study	 	 
	 
	 	 	 	 
	o Research

	 	X Registration	 	 
	 
	 	 	 	 
	o Prototype

	 	o Other:	 	 

1. Project Scope:

1. Registration (CE-mark) of Lekton Motion for neurovascular application and
implementation of minor design changes (hypotube with stiffening wire design for all sizes) Modify stent implantation
procedure for neurovascular vessels: slow inflations, no overdilatation

2. Amendement of design changes (blue prox. Shaft / transparent dist. Shaft / Micrus packaging)

2. Excluded project scope:

NA

3. Comments:

Lekton Motion amber will be a standard Biotronik Product and will be named Pharos

Lekton Motion blue includes the specific Micrus labeling and outer packaging and
will be named Pharos

Note: Micrus may want to revise the label to a more
Micrus standard over time

4. Time schedule

	 	 	 	 	 	 	 
	Milestones	 	Date	 	Remarks
	Application for Specification

	 	 	24.01.05	 	 	Biotronik Vision Team
	Application for Planning/Execution

	 	 	20.09.05	 	 	 
	Review Design Input

	 	 	11.11.05	 	 	 
	Review Design Output

	 	 	13.12.05	 	 	Together with review validation
	Review Validation

	 	 	13.12.05	 	 	Mechanical Validation only / clinical
assessment to be completed after physicians
input
	Estimated Regulatory Approval (LM

amber)

	 	 	28.02.06	 	 	Best case, depending on LGA review and availability of clinical data
	Product Release (LM amber)

	 	 	15.03.06	 	 	 
	Estimated Regulatory Approval (LM blue)

	 	 	30.03.06	 	 	Assessment depending on LGA
	Product Release (LM blue)

	 	 	30.04.06	 	 	With minimum 2 y shelf life (accelerated ageing)

The outcome of the reviews have to be approved by Micrus

	 	 	 
	SOW FINAL

	 	1/3

 

 

5. Budget

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Budget (EUR):	 	Specification	 	 	Planning	 	 	Execution	 	 	Total per type	 
	Internal labor costs
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Contractor labor costs
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	External RD costs
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Non labor costs
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Collaboration Management
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total per phase
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

For the Lekton Motion (amber and blue) the total project costs are 120’000 EURO.

Payment terms:

€40’000          within 5 days after execution of the collaboration agreement

€40’000          within 10 days after release of the Lekton Motion amber

€40’000          within 10 days after release of the Lekton Motion blue

For the future projects the cost are calculated according to the internal FTE rates

6. Transfer price

Fully burdened manufacturing cost per unit:

	 	 	 
	Direct cost per product

	 	€ na for this project
	Indirect cost (plus 40%)

	 	€ na for this project
	Total Transfer Price excluding VAT

	 	€200

Minimum purchase order per quarter: 38 units

7. Forecast

Monthly forecast for the first 12 months

(see attachment Bob C. dated Nov. 10th 2005 / manufacturing forecast)

8. Deliverables

Product Specification

10 test samples from transfer builds for release tests

CE-mark certificates

Documents for approval (Design Input LM blue, Label, IFU)

	 	 	 
	SOW FINAL

	 	1/2

 

 

	 	 	 	 	 
	Issued by : Name

	 	Approved by Biotronik
	 	Approved by Micrus
	 
	 	 	 	 
	Date/Sign: 06.Jan.2006

	 	Date/Sign:
    /s/ Claus Martini    
	 	Date/Sign:     /s/ Robert Stern    

Attachments

- Design Input (PFH) LM Neuro amber

- Product Specification LM Neuro amber (DB 112215)

	 	 	 
	SOW FINAL

	 	3/3

 

 

Formular

Design Input

 

	 	 	 	 	 	 	 
	Project Name:

	 	LM Neuro	 	 	 	 
	Project No:

	 	P0249	 	SAP Project No:
	 	PR140000080
	PFH No/Rev:

	 	PFH 112091 Rev.1
	 	Ref. LTH No/Rev:
	 	N.A.
	Effective Date:

	 	11.11.05	 	 	 	 
	File Name	 	PFH_112091_Rev1_LM_Neuro.doc

Contents:

	 	 	 	 	 	 	 
	1	 	Project scope 
	 	 	2	 
	1.1	 	Project goals 
	 	 	2	 
	1.2	 	Geographical markets 
	 	 	2	 
	1.3	 	Launch date 
	 	 	2	 
	 	 	 
	 	 	 	 
	2	 	Clinical indications/ Intended use 
	 	 	2	 
	 	 	 
	 	 	 	 
	3	 	Product name 
	 	 	2	 
	 	 	 
	 	 	 	 
	4	 	Competitor products 
	 	 	2	 
	4.1	 	Reference products for benchmarking 
	 	 	2	 
	4.2	 	Parent (Biotronik) products 
	 	 	2	 
	 	 	 
	 	 	 	 
	5	 	Applicable standards and documents 
	 	 	2	 
	 	 	 
	 	 	 	 
	6	 	Risk management 
	 	 	3	 
	6.1	 	Related risk analysis 
	 	 	3	 
	6.2	 	Related human factor analysis 
	 	 	3	 
	 	 	 
	 	 	 	 
	7	 	Technical product requirements / characteristics 
	 	 	3	 
	7.1	 	Technical requirements for the T4XS / T4S / T4L / T4XL stent 
	 	 	3	 
	7.2	 	Technical specifications for the entire LM Neuro System 
	 	 	5	 
	7.3	 	Sizes 
	 	 	8	 
	 	 	 
	 	 	 	 
	8	 	Product range 
	 	 	9	 
	 	 	 
	 	 	 	 
	9	 	Target manufacturing costs 
	 	 	9	 
	 	 	 
	 	 	 	 
	10	 	Packaging / Labelling 
	 	 	9	 
	 	 	 
	 	 	 	 
	11	 	Sterilisation 
	 	 	9	 
	 	 	 
	 	 	 	 
	12	 	Shelf life 
	 	 	9	 
	 	 	 
	 	 	 	 
	13	 	Product compatibility 
	 	 	9	 
	13.1	 	Compatibility with accessories / auxiliary devices 
	 	 	9	 
	13.2	 	Compatibility with contrast media 
	 	 	9	 
	 	 	 
	 	 	 	 
	14	 	Approval 
	 	 	10	 
	14.1	 	Issued by: 
	 	 	10	 
	14.2	 	Approval Micrus 
	Fehler! Textmarke nicht definiert.	 

 

 

1 Project scope

1.1 Project goals

Registration of Lekton Motion for neurovascular application and implementation of minor
design changes (hypotube with stiffening wire design for all sizes)

	 	–	 	Modify stent implantation procedure for neurovascular vessels: slow inflations, no overdilatation

1.2 Geographical markets

	•	 	EU (CE-Mark)
	 
	•	 	USA (HDE)

1.3 Launch date

	•	 	EU March 06
	 
	•	 	USA tbd

2 Clinical indications / Intended use

Improving of neurovascular luminal diameter
(stenosis)

Treatment of intracranial aneurysms
(scaffolding)

3 Product name

The project name is LM Neuro. The product name tbd.

4 Competitor products

4.1 Reference products for benchmarking

The listed reference competitor products shall be tested against the LM Neuro for comparison
regarding the key product characteristics:

	•	 	Neuroform (pattern product for aneurysm)
	 
	•	 	Cerebrence, Medtronic (subject to product availability)
	 
	•	 	Neurolink, Guidant (subject to product availability)

4.2 Parent (Biotronik) products

	•	 	N.A., Lekton Motion

5 Applicable standards and documents

The following documents shall apply in their current revision:

	•	 	SOP 100741	Design Control
	 
	•	 	AGP 102610	RD guideline to AC/DC list for development projects
	 
	•	 	ISO EN 10993	Biocompatibility

 

 

6 Risk management

6.1 Related risk analysis

The potential risks associated with the use of the product shall be assessed within
the following risk analysis:

	•	 	PRA112030

6.2 Related human factor analysis

The interaction between the end user and the product shall be assessed within the
following human factor analysis:

	•	 	HUF112094

7 Technical product requirements / characteristics

7.1 Technical requirements for the T4XS / T4S / T4L / T4XL stent

	 	 	 
	Criteria	 	Specification
	1. Material:

	 	Stainless steel for surgical implants AISI 316L, as
defined by ISO 5832-1, ASTM F138-92.
	 
	 	 
	2. Design

	 	Sinusoidal design of the bearing meanders with
transverse joints, straight end of stent due to special
V-form. Wall thickness: 130 ±10mm for T4XL
	 
	 	 
	 

	 	Wall thickness: 90+10mm for T4S and L
	 
	 	 
	 

	 	Wall thickness: 80 ±10mm for T4XS
	 
	 	 
	 
	 	 
	3. Surface

	 	The stent’s metal body shall be electro-polished.
	 
	 	 
	4. Variants (stent diameter):

	 	The stent shall be available in four size variants:
	 
	 	 
	 

	 	- A small T4 variant (designation XS) for dilatation
diameters of 2,0; 2,25 and 2,5 mm; and
	 
	 	 
	 

	 	- A small T4 variant (designation S) for dilatation
diameters of 2,75 and 3,0 mm; and
	 
	 	 
	 

	 	- A larger T4 variant (designation L) for dilatation
diameters of 3,5 and 4,0 mm; and
	 
	 	 
	 

	 	- A larger T4 variant (designation XL) for dilatation
diameters of 4,5 and 5,0 mm.
	 
	 	 
	5. Variants (stent lengths):

	 	The stent shall be available in the following lengths:
	 
	 	 
	 

	 	T4XS:8, 10, 13, 15, 18, 20 mm
	 
	 	 
	 

	 	T4S: 8, 10, 13, 15, 18, 20, 22, 25, 30 mm
	 
	 	 
	 

	 	T4L: 8, 10, 13, 15, 18, 20, 22, 25, 30 mm
	 
	 	 
	 

	 	T4XL: 13, 20, 30, 40 mm
	 
	 	 
	6. Oversizing

	 	All diameter variants must withstand the following
diameter without strut fracture (T4XS up to 3,0mm max.,
T4S up to 3,5mm max., T4L up to 4,5mm max. and T4XL up
to 5,5mm max.)

 

 

	 	 	 
	Criteria	 	Specification
	7. Pressure required for stent
dilatation:

	 	Up to a balloon pressure of
£ 1 bar no diameter change of 3 20%
of the crimped profile shall occur. At a balloon pressure of 3
4 bar the stent shall have an evenly expanded geometry.
	 
	 	 
	8. Elastic recoil:

	 	Recoil £ 5 % for reference sizes: T4XS: 2.5/15; T4S: 3.0/15; T4L
4.0/15; T4XL: 5.0/20.
	 
	 	 
	9. Flexural rigidity when expanded

	 	El of dilated stent £ 50 Nmm2 for reference T4XL 5,0/20
	 
	 	 
	 

	 	El of dilated stent
£ 20 Nmm2 for reference sizes: T4S: 3.0/15; T4L: 4.0/15
	 
	 	 
	 

	 	El of dilated stent £ 10 Nmm2 for reference T4XS 2,5/15
	 
	 	 
	10. Maximum radial force (collapse
pressure)

	 	Pcoll
3 0.9 bar for reference sizes: T4XS:
2.5/15;

Pcoll 3 0.9 bar
for reference sizes: T4S: 3.0/15; T4L: 4.0/15;

Pcoll 3 1.1 bar for reference sizes: T4XL: 5.0/20.
	 
	 	 
	11. Foreshortening of stent during

	 	DL < 5 % for reference sizes: T4XS: 2.5/15; T4S: 3.0/15; T4L:
	expansion:

	 	4.0/15; T4XL 5.0/20.
	 
	 	 
	12. Crack formation:

	 	Stent body surface testing: no cracks or ruptures in the metal stent
body up to and including maximum diameter.
	 
	 	 
	13. Opening behavior

	 	Stent diameter shall not display any difference > 10% over the
entire length at nominal balloon pressure. After complete expansion
the stent must still be positioned between the SDS markers.
	 
	 	 
	14. FEM analysis

	 	An FEM analysis shall be performed in order to determine the level
of stress at maximum physiological load. Crimping behavior and
subsequent dilatation to the maximum designated diameter shall be
simulated. As a result the equivalent stress levels and maximum
expansion shall be documented.
	 
	 	 
	15. Fatigue testing

	 	A dynamic fatigue resistance simulation is required to determine
long-term behavior under implantation conditions. The implantation
duration shall be at least 10 years with at least 420 Mio. stress
cycles at a temperature of 37°C.
	 
	 	 
	16. Surface coverage

	 	The percentage of the vessel wall covered by the dilated stent in
dependency on the stent’s expanded diameter shall be calculated.
	 
	 	 
	17. Radiopacity

	 	All stent variants with markers must be visible under X-rays in an
undilated and dilated condition. This shall be achieved by applying
a gold marker to each end by galvanization.
	 
	 	 
	18. Coating

	 	The stent s metal body and the gold markers shall be coated with
amorphous silicon carbide (a-SiC:H); requirements see DSP-621-014.
	 
	 	 
	19. MR safety

	 	Tests for MR safety (magnetic field interactions, heating and
artifacts) will be conducted using 3.0 Tesla MR system.
	 
	 	 
	20. Corrosion resistance

	 	The stent shall be resistant to corrosion when subjected to
physiological conditions at the implantation site.

 

 

7.2 Technical specifications for the entire LM Neuro System

Criteria

	 	1	 	Design (same as the Lekton Motion coronary stent)

Specification

     • Balloon-expandable stent system

     • Fast exchange catheter

     • Hypotube design with stiffening wire

     • T4 Stent (see 7.1)

	 	2	 	Catheter Characteristic (same as the Lekton Motion coronary stent)

 

	 	a.)	 	Effective length
	 
	 	b.)	 	Crossing Profile = crimp diameter stent
	 
	 	c.)	 	Deflation time from NP (water / contrast medium mixture 50/50% or glycerin/water mixture
30/70%)

140cm

see 7.2.4
criterion 4 b.) Stent

Contrast
media Æ 2.0 – 4.5: £ 20s

Contrast media Æ 5.0: £40s

	 	d.)	 	Inflation time to NP (water / contrast medium mixture 50/50% or glycerin/water mixture
30/70%)

shall be documented

	 	e.)	 	Trackability
Reference sizes 3.0/15

Comparable to or better than predicate devices 
(see 4.1)

	 	3	 	Balloon Characteristic (same as the Lekton Motion coronary stent)

      

	 	a.)	 	Material
	 
	 	b.)	 	Balloon diameter [mm] at nominal pressure (NP)

Nylon

with T4 XS: 2.0, 2.25, 2.5

with T4 S: 2.75, 3.0

with T4 L: 3.5, 4.0

with T4 XL: 4.5, 5.0

	 	c.)	 	Balloon length [mm]

£ stent length + 2mm

	 	d.)	 	Nominal pressure (NP) 
Stent inner diameter

£ 10bar

	 	e.)	 	Rated Burst Pressure (RBP) measured with the stent mounted on the balloon

BalloonÆ 2.0 – 4.0 3 16bar

BalloonÆ 4.5 – 5.0 3 14bar

	 	f.)	 	Radial Compliance (NP to RBP) of the stent inner diameter

max. 12%

	 	g.)	 	Axial Compliance (NP to RBP) measured with the stent mounted on the balloon

max. 10%

	 	4	 	Stent

      

	 	a.)	 	General technical requirements
	 
	 	b.)	 	Crimp diameter [mm]

See Section 7.1.

Balloon 2.0 – 2.5: £ 1.00

 

 

 

Balloon
2.75 – 3.0: £ 1.05

Balloon 3.5 – 4.0: £ 1.15

Balloon 4.5: £ 1.30

Balloon 5.0: £ 1.35

     c.) Stent lengths [mm]

     d.) Minimum Stent retention force [N] Sterile, unstressed

See Section 7.1.

Stent T4 XS:

Balloon
2.0 – 2.5/10 – 20: 3 £1.5

Balloon 2.0 – 2.5/8: 3 1.0

Stent T4 S:

Balloon 2.75 – 3.0/10 – 30: 3 2.0

Balloon 2.75 – 3.0/8: 3 1.5

Stent T4 L:

Balloon 3.5 – 4.0/10 – 30: 3 2.5

Balloon 3.5 – 4.0/8: 3 2.0

Stent T4 XL:

Balloon 4.5 – 5.0/10 – 40: 3 2.5

Balloon 4.5 – 5.0/8: 3 2.0

     e.) Stent retention force after stress Sterile, stressed by trackability testing Reference size 3.0/15

Comparable with Lekton Motion coronary stent

     f.) Flexural rigidity of the crimped stent on the SDS

Same as Lekton Motion coronary stent

     5 Hub, kink protector, clip (same as the
Lekton Motion coronary stent)

 

     a.) Hub

          Type

          Material

2-wing design

Female Luer Lock

PC, transparent

     b.) Kink protector

     c.) Hypotube clip

PEBAX, transparent

PEBAX, black

     6 Proximal Shaft (same as the Lekton Motion coronary stent)

     a.) Hypotube

Hypotube (304L) covered with PA 12 -tubing

color: yellow

     b.) Dimension

     c.) Shaft Marker

2.1F (0.71mm)

Brachial marker: 92 cm from the distal tip

Femoral marker: 102 cm from the distal tip

     7 Distal Shaft (same as the Lekton Motion coronary stent)

 

     a.) Distal Outer Tubing (DOT)

          Material:

PA 12, color: yellow

 

 

	 	 	 
	Dimension:

	 	Balloon 2.0 – 3.5: 2.6F
Balloon 4.0: 2.7F
Balloon 4.5 – 5.0: 2.9F
	b.) Proximal Outer Tubing (POT)
	 	 
	     Material:

	 	PA 12, color: yellow
	     Dimension:

	 	3.1F
	c.) Inner tubing (guide wire lumen)
	 	 
	 
	 	 
	     Material:

	 	Two layer tubing:
	 

	 	- inner layer: PTFE (good gliding properties)
	 

	 	- outer layer: PEBAX 72D
	     Dimension:

	 	Inner diameter > 0.43mm (-» compatibility with 0.014” GW)
	 
	 	 
	8 Tip (same as the Lekton Motion coronary stent)
	 	 
	 
	 	 
	a.) Material:

	 	Soft and flexible
	     Color:

	 	Blue
	b.) Length

	 	1–2 mm
	 
	 	 
	9 Balloon marker (same as the Lekton
	 	 
	   Motion coronary stent)
	 	 
	 
	 	 
	a.) Material / Dimension

	 	Platinum/Iridium (90/10) / Length: 0.5mm
	b.) Marker concept

	 	Distal and proximal from the stent ends
	c.) Distance between markers

	 	£ stent length + 1.0mm
	 
	 	 
	10 Coating (same as the Lekton Motion
	 	 
	coronary stent)
	 	 
	 
	 	 
	a.) Shaft proximal

	 	Hydrophobic Coating
	b.) Shaft distal

	 	Hydrophilic Coating
	 
	 	 
	11 Printing (same as the Lekton Motion
	 	 
	coronary stent)
	 	 
	 
	 	 
	a.) On hub

	 	Product name, nominal stent diameter /stent
length / Lot number – unit number

 

 

7.3 Sizes

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Pos.	 	 	Bezeichnung	 	Durchm.	 	 	Länge	 	 	Pos.	 	 	Bezeichnung	 	 	Durchm.	 	 	Länge	 
	 	 	 	 	T4 XS-XR
	 	 	 	 	 	T4 S-XR

	 	1	 	 	LM Neuro 2.0/8
	 	 	2.0	 	 	 	8	 	 	 	19	 	 	LM Neuro 2.75/8	 	 	2.75	 	 	 	8	 
	 	2	 	 	LM Neuro 2.25/8
	 	 	2.25	 	 	 	8	 	 	 	20	 	 	LM Neuro 3.0/8	 	 	3.0	 	 	 	8	 
	 	3	 	 	LM Neuro 2.5/8
	 	 	2.5	 	 	 	8	 	 	 	21	 	 	LM Neuro 2.75/10	 	 	2.75	 	 	 	10	 
	 	4	 	 	LM Neuro 2.0/10
	 	 	2.0	 	 	 	10	 	 	 	22	 	 	LM Neuro 3.0/10	 	 	3.0	 	 	 	10	 
	 	5	 	 	LM Neuro 2.25/10
	 	 	2.25	 	 	 	10	 	 	 	23	 	 	LM Neuro 2.75/13	 	 	2.75	 	 	 	13	 
	 	6	 	 	LM Neuro 2.5/10
	 	 	2.5	 	 	 	10	 	 	 	24	 	 	LM Neuro 3.0/13	 	 	3.0	 	 	 	13	 
	 	7	 	 	LM Neuro 2.0/13
	 	 	2.0	 	 	 	13	 	 	 	25	 	 	LM Neuro 2.75/15	 	 	2.75	 	 	 	15	 
	 	8	 	 	LM Neuro 2.25/13
	 	 	2.25	 	 	 	13	 	 	 	26	 	 	LM Neuro 3.0/15	 	 	3.0	 	 	 	15	 
	 	9	 	 	LM Neuro 2.5/13
	 	 	2.5	 	 	 	13	 	 	 	27	 	 	LM Neuro 2.75/18	 	 	2.75	 	 	 	18	 
	 	10	 	 	LM Neuro 2.0/15
	 	 	2.0	 	 	 	15	 	 	 	28	 	 	LM Neuro 3.0/18	 	 	3.0	 	 	 	18	 
	 	11	 	 	LM Neuro 2.25/15
	 	 	2.25	 	 	 	15	 	 	 	29	 	 	LM Neuro 2.75/20	 	 	2.75	 	 	 	20	 
	 	12	 	 	LM Neuro 2.5/15
	 	 	2.5	 	 	 	15	 	 	 	30	 	 	LM Neuro 3.0/20	 	 	3.0	 	 	 	20	 
	 	13	 	 	LM Neuro 2.0/18
	 	 	2.0	 	 	 	18	 	 	 	31	 	 	LM Neuro 2.75/22	 	 	2.75	 	 	 	22	 
	 	14	 	 	LM Neuro 2.25/18
	 	 	2.25	 	 	 	18	 	 	 	32	 	 	LM Neuro 3.0/22	 	 	3.0	 	 	 	22	 
	 	15	 	 	LM Neuro 2.5/18
	 	 	2.5	 	 	 	18	 	 	 	33	 	 	LM Neuro 2.75/25	 	 	2.75	 	 	 	25	 
	 	16	 	 	LM Neuro 2.0/20
	 	 	2.0	 	 	 	20	 	 	 	34	 	 	LM Neuro 3.0/25	 	 	3.0	 	 	 	25	 
	 	17	 	 	LM Neuro 2.25/20
	 	 	2.25	 	 	 	20	 	 	 	35	 	 	LM Neuro 2.75/30	 	 	2.75	 	 	 	30	 
	 	18	 	 	LM Neuro 2.5/20
	 	 	2.5	 	 	 	20	 	 	 	36	 	 	LM Neuro 3.0/30	 	 	3.0	 	 	 	30	 
	 	 	 	 	T4 L-XR
	 	 	 	 	 	T4 XL-XR

	 	37	 	 	LM Neuro 3.5/8
	 	 	3.5	 	 	 	8	 	 	 	55	 	 	LM Neuro 4.5/13	 	 	4.5	 	 	 	13	 
	 	38	 	 	LM Neuro 4.0/8
	 	 	4.0	 	 	 	8	 	 	 	56	 	 	LM Neuro 5.0/13	 	 	5.0	 	 	 	13	 
	 	39	 	 	LM Neuro 3.5/10
	 	 	3.5	 	 	 	10	 	 	 	57	 	 	LM Neuro 4.5/20	 	 	4.5	 	 	 	20	 
	 	40	 	 	LM Neuro 4.0/10
	 	 	4.0	 	 	 	10	 	 	 	58	 	 	LM Neuro 5.0/20	 	 	5.0	 	 	 	20	 
	 	41	 	 	LM Neuro 3.5/13
	 	 	3.5	 	 	 	13	 	 	 	59	 	 	LM Neuro 4.5/30	 	 	4.5	 	 	 	30	 
	 	42	 	 	LM Neuro 4.0/13
	 	 	4.0	 	 	 	13	 	 	 	60	 	 	LM Neuro 5.0/30	 	 	5.0	 	 	 	30	 
	 	43	 	 	LM Neuro 3.5/15
	 	 	3.5	 	 	 	15	 	 	 	61	 	 	LM Neuro 4.5/40	 	 	4.5	 	 	 	40	 
	 	44	 	 	LM Neuro 4.0/15
	 	 	4.0	 	 	 	15	 	 	 	62	 	 	LM Neuro 5.0/40	 	 	5.0	 	 	 	40	 
	 	45	 	 	LM Neuro 3.5/18
	 	 	3.5	 	 	 	18	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	46	 	 	LM Neuro 4.0/18
	 	 	4.0	 	 	 	18	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	47	 	 	LM Neuro 3.5/20
	 	 	3.5	 	 	 	20	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	48	 	 	LM Neuro 4.0/20
	 	 	4.0	 	 	 	20	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	49	 	 	LM Neuro 3.5/22
	 	 	3.5	 	 	 	22	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	50	 	 	LM Neuro 4.0/22
	 	 	4.0	 	 	 	22	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	51	 	 	LM Neuro 3.5/25
	 	 	3.5	 	 	 	25	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	52	 	 	LM Neuro 4.0/25
	 	 	4.0	 	 	 	25	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	53	 	 	LM Neuro 3.5/30
	 	 	3.5	 	 	 	30	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	54	 	 	LM Neuro 4.0/30
	 	 	4.0	 	 	 	30	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

 

8   Product range

Range for sale tbd.

9   Target manufacturing costs

N.A.

10  Packaging / Labelling

Type and design of the packaging and label layouts should correspond with those of the Lekton Motion.

11  Sterilisation

	•	 	The sterilization process shall be EO.
	 
	•	 	The maximum amount of sterilisation cycles shall be two.
	 
	•	 	The products shall be sterilised twice for biocompatibility and aging tests.

12  Shelf life

	•	 	The product shelf life shall be three years.

13  Product compatibility

13.1  Compatibility with accessories / auxiliary devices

The product shall be compatible with the following accessories / auxiliary devices:

	•	 	SDS compatible with 0.014” (0.36mm) guide wire
	 
	•	 	Guiding Catheter 5F, min I.D. 0.056” (1.42mm)

13.2  Compatibility with contrast media

The product shall be compatible with standard contrast media.

 

 

14 Approval

14.1 Issued by:

	 	 	 	 	 
	Department / Function	 	Name	 	Signature
	RD Project Manager

	 	Bernd Ewald	 	 

Approved by:

	 	 	 	 	 
	Department / Function	 	Name	 	Signature
	QRV Team Member

	 	Karin Ortlieb	 	 
	CA Team Member

	 	Marcel Schäfer	 	 
	RA Team Member

	 	Marcel Schäfer	 	 
	General Manager

	 	Claus Martini	 	 

 

 

Data Sheet

Performance Data PHAROS

Scope

This data sheet is valid for the following products:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Mat. No.	 	Description	 	Mat. No.	 	Description	 	Mat. No.	 	Description
	356663

	 	PHAROS 2.0/8
	 	 	356686	 	 	PHAROS 2.0/15
	 	 	356709	 	 	PHAROS 2.75/22
	356664

	 	PHAROS 2.25/8
	 	 	356687	 	 	PHAROS 2.25/15
	 	 	356710	 	 	PHAROS 3.0/22
	356665

	 	PHAROS 2.5/8
	 	 	356688	 	 	PHAROS 2.5/15
	 	 	356711	 	 	PHAROS 3.5/22
	356666

	 	PHAROS 2.75/8
	 	 	356689	 	 	PHAROS 2.75/15
	 	 	356712	 	 	PHAROS 4.0/22
	356667

	 	PHAROS 3.0/8
	 	 	356690	 	 	PHAROS 3.0/15
	 	 	356713	 	 	PHAROS 2.75/25
	356668

	 	PHAROS 3.5/8
	 	 	356691	 	 	PHAROS 3.5/15
	 	 	356714	 	 	PHAROS 3.0/25
	356669

	 	PHAROS 4.0/8
	 	 	356692	 	 	PHAROS 4.0/15
	 	 	356715	 	 	PHAROS 3.5/25
	356670

	 	PHAROS 2.0/10
	 	 	356693	 	 	PHAROS 2.0/18
	 	 	356716	 	 	PHAROS 4.0/25
	356671

	 	PHAROS 2.25/10
	 	 	356694	 	 	PHAROS 2.25/18
	 	 	356717	 	 	PHAROS 2.75/30
	356672

	 	PHAROS 2.5/10
	 	 	356695	 	 	PHAROS 2.5/18
	 	 	356718	 	 	PHAROS 3.0/30
	356673

	 	PHAROS 2.75/10
	 	 	356696	 	 	PHAROS 2.75/18
	 	 	356719	 	 	PHAROS 3.5/30
	356674

	 	PHAROS 3.0/10
	 	 	356697	 	 	PHAROS 3.0/18
	 	 	356720	 	 	PHAROS 4.0/30
	356675

	 	PHAROS 3.5/10
	 	 	356698	 	 	PHAROS 3.5/18
	 	 	356721	 	 	PHAROS 4.5/30
	356676

	 	PHAROS 4.0/10
	 	 	356699	 	 	PHAROS 4.0/18
	 	 	356722	 	 	PHAROS 5.0/30
	356677

	 	PHAROS 2.0/13
	 	 	356700	 	 	PHAROS 2.0/20
	 	 	356723	 	 	PHAROS 4.5/40
	356678

	 	PHAROS 2.25/13
	 	 	356701	 	 	PHAROS 2.25/20
	 	 	356724	 	 	PHAROS 5.0/40
	356679

	 	PHAROS 2.5/13
	 	 	356702	 	 	PHAROS 2.5/20	 	 	 	 	 	 
	356680

	 	PHAROS 2.75/13
	 	 	356703	 	 	PHAROS 2.75/20	 	 	 	 	 	 
	356681

	 	PHAROS 3.0/13
	 	 	356704	 	 	PHAROS 3.0/20	 	 	 	 	 	 
	356682

	 	PHAROS 3.5/13
	 	 	356705	 	 	PHAROS 3.5/20	 	 	 	 	 	 
	356683

	 	PHAROS 4.0/13
	 	 	356706	 	 	PHAROS 4.0/20	 	 	 	 	 	 
	356684

	 	PHAROS 4.5/13
	 	 	356707	 	 	PHAROS 4.5/20	 	 	 	 	 	 
	356685

	 	PHAROS 5.0/13
	 	 	356708	 	 	PHAROS 5.0/20	 	 	 	 	 	 

 

 

Requirements

	 	 	 
	Description	 	Value
	Guide wire compatibility

	 	0.014 [inch] (= 0.36 mm)
	Guiding catheter compatibility

	 	5F, min. ID 0.056 [inch] (= 1.42 mm)
	Usable length

	 	1400 ±10 [mm]
	Position of shaft marking

	 	920 ±10 [mm]
	 

	 	1020 ±10 [mm]
	Length of wire lumen

	 	280 ±10 [mm]
	SDS diameter:
	 	 
	Hypotube

	 	2.1 [F]
	Shaft distal for Ø: 2.0 / 2.25 / 2.5 / 2.75 / 3.0 / 3.5 [mm]

	 	2.6 [F]
	Shaft distal for Ø: 4.0 [mm]

	 	2.7 [F]
	Shaft distal for Ø: 4.5/ 5.0 [mm]

	 	2.9 [F]
	Sterilization Type

	 	EO
	Shelf Life

	 	36 months

 

 

Diameter behavior and burst pressure

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Stent
outer diameter [mm]	 
	 	 	2.0	 	 	2.25	 	 	2.5	 	 	2.75	 	 	3.0	 
	Pressure [bar]	 	Min. 0	 	 	Nom.-0	 	 	Max. 0	 	 	Min. 0	 	 	Nom.-0	 	 	Max. 0	 	 	Min. 0	 	 	Nom.-0	 	 	Max. 0	 	 	Min. 0	 	 	Nom.-0	 	 	Max. 0	 	 	Min. 0	 	 	Nom.-0	 	 	Max. 0	 
	 	 	(-5
%)	 	 	 	 	 	(+5
%)	 	 	(-5
%)	 	 	 	 	 	(+5
%)	 	 	(-5
%)	 	 	 	 	 	(+5
%)	 	 	(-5
%)	 	 	 	 	 	(+5
%)	 	 	(-5
%)	 	 	 	 	 	(+5
%)	 
	6
	 	 	1.91	 	 	 	2.01	 	 	 	2.11	 	 	 	2.08	 	 	 	2.19	 	 	 	2.30	 	 	 	2.26	 	 	 	2.38	 	 	 	2.50	 	 	 	2.60	 	 	 	2.74	 	 	 	2.88	 	 	 	2.80	 	 	 	2.95	 	 	 	3.10	 
	7
	 	 	1.94	 	 	 	2.05	 	 	 	2.15	 	 	 	2.13	 	 	 	2.24	 	 	 	2.35	 	 	 	2.32	 	 	 	2.44	 	 	 	2.57	 	 	 	2.66	 	 	 	2.80	 	 	 	2.94	 	 	 	2.86	 	 	 	3.01	 	 	 	3.16	 
	8
	 	 	1.97	 	 	 	2.08	 	 	 	2.18	 	 	 	2.16	 	 	 	2.28	 	 	 	2.39	 	 	 	2.38	 	 	 	2.50	 	 	 	2.63	 	 	 	2.72	 	 	 	2.86	 	 	 	3.00	 	 	 	2.92	 	 	 	3.07	 	 	 	3.22	 
	9
	 	 	2.00	 	 	 	2.10	 	 	 	2.21	 	 	 	2.20	 	 	 	2.32	 	 	 	2.43	 	 	 	2.43	 	 	 	2.56	 	 	 	2.68	 	 	 	2.76	 	 	 	2.91	 	 	 	3.05	 	 	 	2.96	 	 	 	3.12	 	 	 	3.28	 
	10
	 	 	2.02	 	 	 	2.12	 	 	 	2.23	 	 	 	2.23	 	 	 	2.35	 	 	 	2.47	 	 	 	2.47	 	 	 	2.60	 	 	 	2.73	 	 	 	2.80	 	 	 	2.95	 	 	 	3.09	 	 	 	3.00	 	 	 	3.16	 	 	 	3.32	 
	11
	 	 	2.04	 	 	 	2.15	 	 	 	2.25	 	 	 	2.26	 	 	 	2.38	 	 	 	2.50	 	 	 	2.51	 	 	 	2.64	 	 	 	2.78	 	 	 	2.84	 	 	 	2.98	 	 	 	3.13	 	 	 	3.04	 	 	 	3.20	 	 	 	3.36	 
	12
	 	 	2.05	 	 	 	2.16	 	 	 	2.27	 	 	 	2.29	 	 	 	2.41	 	 	 	2.53	 	 	 	2.55	 	 	 	2.68	 	 	 	2.81	 	 	 	2.87	 	 	 	3.02	 	 	 	3.17	 	 	 	3.07	 	 	 	3.23	 	 	 	3.40	 
	13
	 	 	2.07	 	 	 	2.18	 	 	 	2.29	 	 	 	2.31	 	 	 	2.43	 	 	 	2.55	 	 	 	2.58	 	 	 	2.71	 	 	 	2.85	 	 	 	2.90	 	 	 	3.05	 	 	 	3.21	 	 	 	3.10	 	 	 	3.27	 	 	 	3.43	 
	14
	 	 	2.09	 	 	 	2.20	 	 	 	2.31	 	 	 	2.33	 	 	 	2.45	 	 	 	2.58	 	 	 	2.60	 	 	 	2.74	 	 	 	2.88	 	 	 	2.93	 	 	 	3.08	 	 	 	3.24	 	 	 	3.14	 	 	 	3.30	 	 	 	3.47	 
	15
	 	 	2.10	 	 	 	2.21	 	 	 	2.32	 	 	 	2.35	 	 	 	2.47	 	 	 	2.60	 	 	 	2.63	 	 	 	2.77	 	 	 	2.91	 	 	 	2.96	 	 	 	3.11	 	 	 	3.37	 	 	 	3.17	 	 	 	3.33	 	 	 	3.50	 
	16
	 	 	2.11	 	 	 	2.22	 	 	 	2.34	 	 	 	2.37	 	 	 	2.50	 	 	 	2.62	 	 	 	2.66	 	 	 	2.80	 	 	 	2.94	 	 	 	2.99	 	 	 	3.15	 	 	 	3.30	 	 	 	3.20	 	 	 	3.37	 	 	 	3.54	 
	17
	 	 	2.12	 	 	 	2.24	 	 	 	2.35	 	 	 	2.39	 	 	 	2.51	 	 	 	2.64	 	 	 	2.69	 	 	 	2.83	 	 	 	2.97	 	 	 	3.02	 	 	 	3.17	 	 	 	3.33	 	 	 	3.23	 	 	 	3.40	 	 	 	3.57	 
	18
	 	 	2.14	 	 	 	2.25	 	 	 	2.36	 	 	 	2.40	 	 	 	2.53	 	 	 	2.66	 	 	 	2.72	 	 	 	2.86	 	 	 	3.00	 	 	 	3.05	 	 	 	3.21	 	 	 	3.37	 	 	 	3.26	 	 	 	3.43	 	 	 	3.61	 
	NP =
Nominal Pressure [bar]
	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 
	RBP =
Rated Burst Pressure [bar]
	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 
	MAB = Minimum Allowed Burst
[bar] (Warning Limit)
	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 

 

 

Diameter behavior and burst pressure

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	Stent outer diameter [mm]	 
	 	 	3.5	 	 	4.0	 	 	4.5	 	 	5.0	 
	Pressure [bar]	 	Min. Ø	 	 	Nom.-Ø	 	 	Max. Ø	 	 	Min. Ø	 	 	Nom.-Ø	 	 	Max. Ø	 	 	Min. Ø	 	 	Nom.-Ø	 	 	Max. Ø	 	 	Min. Ø	 	 	Nom.-Ø	 	 	Max. Ø	 
	 	 	(-5 %)	 	 	 	 	 	(+5%)	 	 	(-5 %)	 	 	 	 	 	(+5 %)	 	 	(-5 %)	 	 	 	 	 	(+5 %)	 	 	(-5%)	 	 	 	 	 	(+5 %)	 
	6
	 	 	3.33	 	 	 	3.50	 	 	 	3.68	 	 	 	3.74	 	 	 	3.93	 	 	 	4.13	 	 	 	4.18	 	 	 	4.40	 	 	 	4.62	 	 	 	4.52	 	 	 	4.75	 	 	 	4.99	 
	7
	 	 	3.39	 	 	 	3.57	 	 	 	3.75	 	 	 	3.82	 	 	 	4.02	 	 	 	4.22	 	 	 	4.27	 	 	 	4.50	 	 	 	4.72	 	 	 	4.63	 	 	 	4.87	 	 	 	5.12	 
	8
	 	 	3.44	 	 	 	3.63	 	 	 	3.81	 	 	 	3.89	 	 	 	4.10	 	 	 	4.30	 	 	 	4.36	 	 	 	4.58	 	 	 	4.81	 	 	 	4.73	 	 	 	4.98	 	 	 	5.23	 
	9
	 	 	3.49	 	 	 	3.67	 	 	 	3.86	 	 	 	3.95	 	 	 	4.16	 	 	 	4.36	 	 	 	4.41	 	 	 	4.64	 	 	 	4.88	 	 	 	4.83	 	 	 	5.09	 	 	 	5.34	 
	10
	 	 	3.53	 	 	 	3.72	 	 	 	3.90	 	 	 	4.00	 	 	 	4.21	 	 	 	4.42	 	 	 	4.47	 	 	 	4.71	 	 	 	4.95	 	 	 	4.90	 	 	 	5.16	 	 	 	5.42	 
	11
	 	 	3.57	 	 	 	3.76	 	 	 	3.95	 	 	 	4.05	 	 	 	4.26	 	 	 	4.47	 	 	 	4.51	 	 	 	4.75	 	 	 	4.99	 	 	 	4.95	 	 	 	5.21	 	 	 	5.48	 
	12
	 	 	3.61	 	 	 	3.80	 	 	 	3.98	 	 	 	4.09	 	 	 	4.31	 	 	 	4.52	 	 	 	4.55	 	 	 	4.79	 	 	 	5.03	 	 	 	5.01	 	 	 	5.27	 	 	 	5.54	 
	13
	 	 	3.64	 	 	 	3.83	 	 	 	4.02	 	 	 	4.13	 	 	 	4.35	 	 	 	4.56	 	 	 	4.59	 	 	 	4.84	 	 	 	5.08	 	 	 	5.06	 	 	 	5.32	 	 	 	5.59	 
	14
	 	 	3.67	 	 	 	3.87	 	 	 	4.06	 	 	 	4.17	 	 	 	4.39	 	 	 	4.61	 	 	 	4.64	 	 	 	4.88	 	 	 	5.12	 	 	 	5.11	 	 	 	5.38	 	 	 	5.64	 
	15
	 	 	3.71	 	 	 	3.90	 	 	 	4.10	 	 	 	4.21	 	 	 	4.43	 	 	 	4.65	 	 	 	4.67	 	 	 	4.92	 	 	 	5.17	 	 	 	5.16	 	 	 	5.43	 	 	 	5.70	 
	16
	 	 	3.74	 	 	 	3.94	 	 	 	4.14	 	 	 	4.25	 	 	 	4.47	 	 	 	4.69	 	 	 	4.71	 	 	 	4.96	 	 	 	5.21	 	 	 	5.21	 	 	 	5.48	 	 	 	5.76	 
	17
	 	 	3.78	 	 	 	3.98	 	 	 	4.18	 	 	 	4.29	 	 	 	4.51	 	 	 	4.74	 	 	 	4.75	 	 	 	5.00	 	 	 	5.25	 	 	 	5.25	 	 	 	5.53	 	 	 	5.81	 
	18
	 	 	3.82	 	 	 	4.02	 	 	 	4.23	 	 	 	4.33	 	 	 	4.56	 	 	 	4.79	 	 	 	4.80	 	 	 	5.05	 	 	 	5.30	 	 	 	5.30	 	 	 	5.58	 	 	 	5.86	 
	NP = Nominal Pressure [bar]
	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 	 	 	 	 	 	 	10	 	 	 	 	 
	RBP = Rated Burst Pressure [bar]
	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 
	MAB = Minimum Allowed Burst [bar] (Warning Limit)
	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 	 	 	 	 	 	 	19	 	 	 	 	 

 

 

Performance data

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Material / Description	 	 	Balloon	 	 	Stent Retention Force	 	 	Stent Geometry	 	 	Tensile Strength /	 
	 	 	 	 	 	 	 	 	 	 	Deflation Time	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Warning Limit	 
	Material-No.	 	Balloon	 	 	Stent length	 	 	Glycerine mix	 	 	Warning	 	 	Rated Stent	 	 	Diameter when	 	 	Length when	 	 	 	 	 
	 	 	diameter	 	 	 	 	 	 	30/70 %	 	 	Limit	 	 	Retention Force	 	 	crimped	 	 	crimped	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	(γ = 0.95/p = 0.95)	 	 	 	 	 	 	 	 	 	 	 
	 	 	[mm]	 	 	[mm]	 	t max[s]	 	F min. [N]	 	 	 	[mm]	 	[mm]	 	 	F min. [N]	 
	356663
	 	 	2.0	 	 	 	8	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.88 +0.05 / –0.08	 	 	 	8.3 ±0.20	 	 	 	 	 
	356664
	 	 	2.25	 	 	 	8	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.89 +0.05 / –0.08	 	 	 	8.3 ±0.20	 	 	 	 	 
	356665
	 	 	2.5	 	 	 	8	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.90 +0.05 / –0.08	 	 	 	8.3 ±0.20	 	 	 	 	 
	356666
	 	 	2.75	 	 	 	8	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.98 +0.05 / –0.08	 	 	 	8.3 ±0.20	 	 	 	 	 
	356667
	 	 	3.0	 	 	 	8	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.99 +0.05 / –0.08	 	 	 	8.3 ±0.20	 	 	 	 	 
	356668
	 	 	3.5	 	 	 	8	 	 	 	20	 	 	 	2.0	 	 	 	1.0	 	 	 	1.06 +0.05 / –0.08	 	 	 	8.1 ±0.20	 	 	 	 	 
	356669
	 	 	4.0	 	 	 	8	 	 	 	20	 	 	 	2.0	 	 	 	1.0	 	 	 	1.08 +0.05 / –0.08	 	 	 	8.1 ±0.20	 	 	 	 	 
	356670
	 	 	2.0	 	 	 	10	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.88 +0.05 / –0.08	 	 	 	10.3 ±0.20	 	 	 	 	 
	356671
	 	 	2.25	 	 	 	10	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.89 +0.05 / –0.08	 	 	 	10.3 ±0.20	 	 	 	 	 
	356672
	 	 	2.5	 	 	 	10	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.90 +0.05 / –0.08	 	 	 	10.3 ±0.20	 	 	 	 	 
	356673
	 	 	2.75	 	 	 	10	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	10.3 ±0.20	 	 	 	 	 
	356674
	 	 	3.0	 	 	 	10	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	10.3 ±0.20	 	 	 	5.0 / 7.0	 
	356675
	 	 	3.5	 	 	 	10	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	9.8 ±0.20	 	 	 	 	 
	356676
	 	 	4.0	 	 	 	10	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	9.8 ±0.20	 	 	 	 	 
	356677
	 	 	2.0	 	 	 	13	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.88 +0.05 / –0.08	 	 	 	13.0 ±0.20	 	 	 	 	 
	356678
	 	 	2.25	 	 	 	13	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.89 +0.05 / –0.08	 	 	 	13.0 ±0.20	 	 	 	 	 
	356679
	 	 	2.5	 	 	 	13	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.90 +0.05 / –0.08	 	 	 	13.0 ±0.20	 	 	 	 	 
	356680
	 	 	2.75	 	 	 	13	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	12.8 ±0.20	 	 	 	 	 
	356681
	 	 	3.0	 	 	 	13	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	12.8 ±0.20	 	 	 	 	 
	356682
	 	 	3.5	 	 	 	13	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	12.8 ±0.20	 	 	 	 	 
	356683
	 	 	4.0	 	 	 	13	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	12.8 ±0.20	 	 	 	 	 
	356684
	 	 	4.5	 	 	 	13	 	 	 	20	 	 	 	3.5	 	 	 	2.5	 	 	 	1.22 ±0.08	 	 	 	13.0 ±0.20	 	 	 	 	 
	356685
	 	 	5.0	 	 	 	13	 	 	 	30	 	 	 	3.5	 	 	 	2.5	 	 	 	1.26 ±0.08	 	 	 	13.0 ±0.20	 	 	 	 	 

 

 

Performance data

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Material / Description	 	 	Balloon	 	 	Stent Retention Force	 	 	Stent Geometry	 	 	Tensile Strength /	 
	 	 	 	 	 	 	 	 	 	 	Deflation Time	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Warning Limit	 
	Material-No.	 	Balloon	 	 	Stent length	 	 	Glycerine mix	 	 	Warning	 	 	Rated Stent	 	 	Diameter when	 	 	Length when	 	 	 	 	 
	 	 	diameter	 	 	 	 	 	 	30/70 %	 	 	Limit	 	 	Retention Force	 	 	crimped	 	 	crimped	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	(γ = 0.95/p = 0.95)	 	 	 	 	 	 	 	 	 	 	 
	 	 	[mm]	 	 	[mm]	 	t max[s]	 	F min. [N]	 	 	 	[mm]	 	[mm]	 	 	F min. [N]	 
	356686
	 	 	2.0	 	 	 	15	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.88 +0.05 / –0.08	 	 	 	15.0 ±0.20	 	 	 	 	 
	356687
	 	 	2.25	 	 	 	15	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.89 +0.05 / –0.08	 	 	 	15.0 ±0.20	 	 	 	 	 
	356688
	 	 	2.5	 	 	 	15	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.90 +0.05 / –0.08	 	 	 	15.0 ±0.20	 	 	 	 	 
	356689
	 	 	2.75	 	 	 	15	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	14.8 ±0.20	 	 	 	 	 
	356690
	 	 	3.0	 	 	 	15	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	14.8 ±0.20	 	 	 	 	 
	356691
	 	 	3.5	 	 	 	15	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	14.5 ±0.20	 	 	 	 	 
	356692
	 	 	4.0	 	 	 	15	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	14.5 ±0.20	 	 	 	 	 
	356693
	 	 	2.0	 	 	 	18	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.88 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	 	 
	356694
	 	 	2.25	 	 	 	18	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.89 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	 	 
	356695
	 	 	2.5	 	 	 	18	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.90 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	 	 
	356696
	 	 	2.75	 	 	 	18	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	 	 
	356697
	 	 	3.0	 	 	 	18	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	5.0 / 7.0	 
	356698
	 	 	3.5	 	 	 	18	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	 	 
	356699
	 	 	4.0	 	 	 	18	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	18.1 ±0.20	 	 	 	 	 
	356700
	 	 	2.0	 	 	 	20	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.88 +0.05 / –0.08	 	 	 	20.0 ±0.30	 	 	 	 	 
	356701
	 	 	2.25	 	 	 	20	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.89 +0.05 / –0.08	 	 	 	20.0 ±0.30	 	 	 	 	 
	356702
	 	 	2.5	 	 	 	20	 	 	 	20	 	 	 	1.5	 	 	 	1.0	 	 	 	0.90 +0.05 / –0.08	 	 	 	20.0 ±0.30	 	 	 	 	 
	356703
	 	 	2.75	 	 	 	20	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	20.0 ±0.30	 	 	 	 	 
	356704
	 	 	3.0	 	 	 	20	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	20.0 ±0.30	 	 	 	 	 
	356705
	 	 	3.5	 	 	 	20	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	19.8 ±0.30	 	 	 	 	 
	356706
	 	 	4.0	 	 	 	20	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	19.8 ±0.30	 	 	 	 	 
	356707
	 	 	4.5	 	 	 	20	 	 	 	20	 	 	 	3.5	 	 	 	3.0	 	 	 	1.22 ±0.08	 	 	 	19.1 ±0.30	 	 	 	 	 
	356708
	 	 	5.0	 	 	 	20	 	 	 	30	 	 	 	3.5	 	 	 	3.0	 	 	 	1.26 ±0.08	 	 	 	19.1 ±0.30	 	 	 	 	 

 

 

Performance data

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Material / Description	 	 	Balloon	 	 	Stent Retention Force	 	 	Stent Geometry	 	 	Tensile Strength /	 
	 	 	 	 	 	 	 	 	 	 	Deflation Time	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Warning Limit	 
	Material-No.	 	Balloon	 	 	Stent length	 	 	Glycerine mix	 	 	Warning	 	 	Rated Stent	 	 	Diameter when	 	 	Length when	 	 	 	 	 
	 	 	diameter	 	 	 	 	 	 	30/70 %	 	 	Limit	 	 	Retention Force	 	 	crimped	 	 	crimped	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	(γ = 0.95/p = 0.95)	 	 	 	 	 	 	 	 	 	 	 
	 	 	[mm]	 	 	[mm]	 	t max[s]	 	F min. [N]	 	 	 	[mm]	 	[mm]	 	 	F min. [N]	 
	356709
	 	 	2.75	 	 	 	22	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	22.3 ±0.30	 	 	 	 	 
	356710
	 	 	3.0	 	 	 	22	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	22.3 ±0.30	 	 	 	 	 
	356711
	 	 	3.5	 	 	 	22	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	22.3 ±0.30	 	 	 	 	 
	356712
	 	 	4.0	 	 	 	22	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	22.3 ±0.30	 	 	 	 	 
	356713
	 	 	2.75	 	 	 	25	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	24.5 ±0.30	 	 	 	 	 
	356714
	 	 	3.0	 	 	 	25	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	24.5 ±0.30	 	 	 	 	 
	356715
	 	 	3.5	 	 	 	25	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	24.5 ±0.30	 	 	 	 	 
	356716
	 	 	4.0	 	 	 	25	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	24.5 ±0.30	 	 	 	5.0 / 7.0	 
	356717
	 	 	2.75	 	 	 	30	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.98 +0.05 / –0.08	 	 	 	29.6 ±0.30	 	 	 	 	 
	356718
	 	 	3.0	 	 	 	30	 	 	 	20	 	 	 	2.0	 	 	 	1.5	 	 	 	0.99 +0.05 / –0.08	 	 	 	29.6 ±0.30	 	 	 	 	 
	356719
	 	 	3.5	 	 	 	30	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.06 +0.05 / –0.08	 	 	 	29.2 ±0.30	 	 	 	 	 
	356720
	 	 	4.0	 	 	 	30	 	 	 	20	 	 	 	2.5	 	 	 	1.5	 	 	 	1.08 +0.05 / –0.08	 	 	 	29.2 ±0.30	 	 	 	 	 
	356721
	 	 	4.5	 	 	 	30	 	 	 	20	 	 	 	3.5	 	 	 	3.0	 	 	 	1.22 ±0.08	 	 	 	29.8 ±0.30	 	 	 	 	 
	356722
	 	 	5.0	 	 	 	30	 	 	 	30	 	 	 	3.5	 	 	 	3.0	 	 	 	1.26 ±0.08	 	 	 	29.8 ±0.30	 	 	 	 	 
	356723
	 	 	4.5	 	 	 	40	 	 	 	20	 	 	 	3.5	 	 	 	3.0	 	 	 	1.22 ±0.08	 	 	 	39.0 ±0.30	 	 	 	 	 
	356724
	 	 	5.0	 	 	 	40	 	 	 	30	 	 	 	3.5	 	 	 	3.0	 	 	 	1.26 ±0.08	 	 	 	39.0 ±0.30	 	 	 	 	 

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Feb-06	 	 	Mar-06	 	 	1Q2006	 	 	Apr-06	 	 	May-06	 	 	Jun-06	 
	Manufacturing Forecast by Sizes (Includes non-sterile demo units + units needed so that appropriate si	 
	2.25 x 8mm
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	 	 	 	 	 	 	 	 	0	 
	2.5 x 8mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	10	 	 	 	1	 	 	 	1	 
	2.75 x 8mm
	 	 	2	 	 	 	2	 	 	 	4	 	 	 	10	 	 	 	4	 	 	 	1	 
	3.0 x 8mm
	 	 	2	 	 	 	2	 	 	 	4	 	 	 	10	 	 	 	4	 	 	 	1	 
	3.5 x 8mm
	 	 	2	 	 	 	2	 	 	 	4	 	 	 	10	 	 	 	4	 	 	 	1	 
	4.0 x 8mm
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	 	 	 	 	 	 	 	 	 	 
	2.25 x 10mm
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	 	 	 	 	 	 	 	 	 	 
	2.5 x 10mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	1	 	 	 	1	 
	2.75 x 10mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	4	 	 	 	1	 
	3.0 x 10mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	4	 	 	 	1	 
	3.5 x 10mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	1	 	 	 	1	 
	4.0 x 10mm
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	7	 	 	 	1	 	 	 	1	 
	2.25 x 13mm
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	 	 	 	 	 	 	 	 	 	 
	2.5 x 13mm
	 	 	1	 	 	 	1	 	 	 	2	 	 	 	7	 	 	 	1	 	 	 	1	 
	2.75 x 13mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	3	 	 	 	1	 
	3.0 x 13mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	3	 	 	 	1	 
	3.5 x 13mm
	 	 	1	 	 	 	1	 	 	 	2	 	 	 	7	 	 	 	3	 	 	 	1	 
	4.0 x 13mm
	 	 	 	 	 	 	 	 	 	 	0	 	 	 	 	 	 	 	 	 	 	 	 	 
	2.5 x 15mm
	 	 	1	 	 	 	1	 	 	 	2	 	 	 	7	 	 	 	1	 	 	 	1	 
	3.0 x 15mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	1	 	 	 	1	 
	3.5 x 15mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	1	 	 	 	1	 
	3.5 x 18mm
	 	 	2	 	 	 	1	 	 	 	3	 	 	 	7	 	 	 	1	 	 	 	1	 
	4.0 x 18mm
	 	 	1	 	 	 	1	 	 	 	2	 	 	 	 	 	 	 	1	 	 	 	1	 
	LM Neuro — Total (all non-rev)
	 	 	30	 	 	 	20	 	 	 	50	 	 	 	0	 	 	 	0	 	 	 	0	 
	LM Blue — Total
	 	 	0	 	 	 	0	 	 	 	0	 	 	 	131	 	 	 	39	 	 	 	18	 

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	2Q2006	 	Jul-06	 	 	Aug-06	 	 	Sep-06	 	 	3Q2006	 	 	Oct-06	 	 	Nov-06	 	 	Dec-06	 	 	4Q2006	 
	zing is possible)	 
	0
	 	 	1	 	 	 	1	 	 	 	2	 	 	 	4	 	 	 	2	 	 	 	2	 	 	 	2	 	 	 	6	 
	12
	 	 	5	 	 	 	2	 	 	 	2	 	 	 	9	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	15
	 	 	6	 	 	 	3	 	 	 	2	 	 	 	11	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	15
	 	 	6	 	 	 	3	 	 	 	2	 	 	 	11	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	15
	 	 	5	 	 	 	3	 	 	 	2	 	 	 	10	 	 	 	6	 	 	 	4	 	 	 	4	 	 	 	14	 
	0
	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 
	0
	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 
	9
	 	 	5	 	 	 	2	 	 	 	2	 	 	 	9	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	12
	 	 	6	 	 	 	3	 	 	 	2	 	 	 	11	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	12
	 	 	6	 	 	 	3	 	 	 	2	 	 	 	11	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	9
	 	 	5	 	 	 	3	 	 	 	2	 	 	 	10	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	9
	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 
	0
	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 
	9
	 	 	4	 	 	 	1	 	 	 	1	 	 	 	6	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	11
	 	 	5	 	 	 	1	 	 	 	1	 	 	 	7	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	11
	 	 	5	 	 	 	1	 	 	 	1	 	 	 	7	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	11
	 	 	4	 	 	 	1	 	 	 	1	 	 	 	6	 	 	 	6	 	 	 	5	 	 	 	5	 	 	 	16	 
	0
	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 
	9
	 	 	2	 	 	 	1	 	 	 	1	 	 	 	4	 	 	 	2	 	 	 	2	 	 	 	2	 	 	 	6	 
	9
	 	 	2	 	 	 	1	 	 	 	1	 	 	 	4	 	 	 	2	 	 	 	2	 	 	 	2	 	 	 	6	 
	9
	 	 	2	 	 	 	1	 	 	 	1	 	 	 	4	 	 	 	2	 	 	 	2	 	 	 	2	 	 	 	6	 
	9
	 	 	2	 	 	 	1	 	 	 	1	 	 	 	4	 	 	 	2	 	 	 	2	 	 	 	2	 	 	 	6	 
	2
	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 	 	 	1	 	 	 	1	 	 	 	1	 	 	 	3	 
	0
	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 
	188
	 	 	77	 	 	 	37	 	 	 	32	 	 	 	146	 	 	 	88	 	 	 	75	 	 	 	75	 	 	 	238	 

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1Q2007	 	2Q2007	 	 	3Q2007	 	 	4Q2007	 	 	1Q2008	 	 	2Q2008	 	 	3Q2008	 	 	4Q2008exv4w1

 

EXHIBIT 4.1

 

 

ALSIUS CORPORATION

     The Corporation will furnish to any shareholder, upon written request and without charge, a
summary of the designations, relative rights, preferences and limitations applicable to each class
of its capital stock and the variations in rights, preferences and limitations determined for each
series within a class, and the authority of the board of directors to determine variations for
future series.

     The following abbreviations, when used in the inscription on the face of this certificate, shall be
construed as though they were written out in full according to applicable laws or regulations:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TEN COM

	 	—
	 	as tenants in common
	 	 UNIF GIFT MIN ACT
— 
	 	 	 	 as Custodian for 
	 	 	 	 UNIF TRAN MIN ACT
— 
	 	 	 	 as Custodian for 	 	 
	 

	 	 	 	 	 	 	 
	 	 
	 	 
	 	 
	TEN ENT

	 	—
	 	as tenants by the
	 	 	 	(Cust)
	 	 	 	(Minor)
	 	 	 	(Cust)
	 	 	 	(Minor)
	 	 	 	 	entireties	 	 	 	under Uniform Gifts to Minors
	 	 	 	under Uniform Transfers to Minors 

	 
	JT TEN

	 	—
	 	as joint
tenants with
	 	 	 	Act
	 	 	 	 	 	 	 	Act	 	 	 	 
	 

	 	 	 	right
of survivorship and
	 	 	 	 
    (State)
	 	 	 	 	 	 
    (State)	 	 
	 

	 	 	 	not as tenants in common
	 	 	 	 
	 	 	 	 	 	 	 	 
	 
	TOD

	 	—
	 	transfer on
death direction in
event of owner’s
death, to person
named on face	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

Additional abbreviations may also be used though not in the above list.

For Value Received,____________________hereby sell, assign and transfer unto

	 	 	 	 
	 	PLEASE INSERT SOCIAL SECURITY OR OTHER

IDENTIFYING NUMBER OF ASSIGNEE	 	 
	 	 

	 	 

	 	 	 	 	 
	 
	(PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS, INCLUDING ZIP CODE, OF ASSIGNEE)

	 
	 	 	 	 
	 
	 
	 	 	 	 
	 
	 	 	 	 
	 
	 
	 	 	 	 
	 

	 	 	 	Shares
	 	 	 
	of the Stock represented by the within certificate and do hereby irrevocably constitute and appoint
	 
	 	 	 	 
	 

	 	 	 	attorney,
	 	 	 
	to transfer the same on the books of the within-named Corporation, with full power of substitution in the premises.

Dated_________________________________________

	 	 	 	 	 	 	 	 
	 	 

	 	 	 	X 	 	 
	 	 

	 	 	 	 	 
	 	 
	 	 	 	 	 	 
	 	NAME: THE SIGNATURE(S) TO THIS
ASSIGNMENT
MUST CORRESPOND WITH THE
NAME(S) AS WRITTEN
UPON THE
FACE OF THE CERTIFICATE IN
EVERY PARTICULAR,
WITHOUT ALTERATION OR
ENLARGEMENT OR
ANY CHANGE
WHATEVER.
	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 
	 	 

	 	 	 	X	 	 
	 	 

	 	 	 	 	 
	 	 
	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 
	 	Signature Guaranteed By

	 
	X	 	 
	 	 

	 	 	 	 	 

	 	 	 	 	 
	 

	 	 	 	 
	 

	 	 	ALL GUARANTEES MUST BE MADE BY A FINANCIAL INSTITUTION (SUCH AS A BANK OR BROKER) WHICH IS A
PARTICIPANT IN THE SECURITIES TRANSFER AGENTS MEDALLION PROGRAM (“STAMP”), THE NEW YORK STOCK
EXCHANGE, INC. MEDALLION SIGNATURE PROGRAM (“MSP”), OR THE STOCK EXCHANGES MEDALLION PROGRAM
(“SEMP”) AND MUST NOT BE DATED. GUARANTEES BY A NOTARY
PUBLIC ARE NOT ACCEPTABLE.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00105-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00105-of-00352.parquet"}]]