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.

 

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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

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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.

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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.

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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

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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.

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     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.

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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

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     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

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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.

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          (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

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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

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     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

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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

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          (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

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          (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

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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

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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

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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.

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     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

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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

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          (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

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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.

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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

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          (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.

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     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

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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.

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     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
 
               

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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.

 

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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.

 

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EXHIBIT C
INITIAL STATEMENT OF WORK

 

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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

 

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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

 

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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

 

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(BIOTRONIK LOGO) [f21047f2104712.gif]
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.  

 

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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

 

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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    

 

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(BIOTRONIK LOGO) [f21047f2104712.gif]
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            

 

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(BIOTRONIK LOGO) [f21047f2104713.gif]
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

 

--------------------------------------------------------------------------------

 

(BIOTRUNK LOGO) [f21047f2104713.gif]
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          

 

--------------------------------------------------------------------------------

 

(BIOTRUNK LOGO) [f21047f2104713.gif]
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     4Q2008