Exhibit 10.12


 


AMENDED AND RESTATED


 


LICENSE
AGREEMENT


 


THIS AMENDED AND RESTATED LICENSE AGREEMENT (“Restated Agreement”) is effective as of the 3rd day of
December, 2007 (the “Effective Date”) by and between XTENT, Inc., a
Delaware corporation (“XTENT”),
Biosensors International Group, Ltd., a Bermuda corporation (“BIG”), and Biosensors Europe S.A., a corporation organized
under the laws of Switzerland (“BESA”), a
wholly owned subsidiary of BIG.  BESA,
BIG, and XTENT will be referred to collectively as the “Parties”.


 


RECITALS


 


A.   On May 4,
2004 (the “Original Effective Date”), XTENT,
Occam International B.V. (“Occam”) and Sun
Biomedical Ltd. (“Sun”) entered
into that certain License Agreement dated May 4, 2004 (the “Original Agreement”). 
Since the Original Effective Date, Sun formally changed its name to
Biosensors International Group Ltd. and all of Occam’s rights and obligations
under the Original Agreement were transferred and assigned to BESA.


 


B.   On February 9,
2005, XTENT, Occam and Sun executed that certain First Amendment to License
Agreement concerning Occam’s rights to participate in any financings or
offerings of XTENT (the “First Amendment”).  It is the intent of the Parties that the
First Amendment shall remain in force and effect and shall not be affected by
the execution of this Restated Agreement.


 


C.   BESA and
its Affiliates are engaged in conducting research and clinical trials relating
to drug-eluting stents using various proprietary drug compounds.  In the course of such research and clinical
trials, BESA and its Affiliates have acquired and/or developed certain
proprietary technologies and techniques, including BESA’s Drug/Polymer
Composite Formulation, Biolimus A9 and BESA’s Polymer Coating (each as defined
below).


 


D.   XTENT is engaged
in conducting research and clinical trials related to XTENT Stent Systems (as
defined below) consisting of a series of short Stents on a delivery catheter,
where the angioplasty operator has the ability to selectively deploy a  number of short Stents as a portion of the
total number of Stents in a series to be simultaneously delivered  by the delivery catheter, and which Stent
Systems are used in connection with coronary and peripheral vascular treatments
(the “XTENT Stent System”).


 


E.   The
Parties desire to amend and restate the terms and conditions of the Original
Agreement (excepting the First Amendment and those certain agreements set forth
on Exhibit A, attached hereto.


 


 


1

















 


NOW, THEREFORE, in consideration of the mutual
agreements contained in this Restated Agreement, the Parties agree as follows:


 


ARTICLE I




DEFINITIONS


 


For purposes of this Restated Agreement, the
following terms will have the meanings set forth below (such definitions to be
equally applicable to both the singular and plural forms of the terms
defined).  Except as otherwise indicated,
all agreements or instruments defined or identified below will mean such
agreements or instruments as from time to time assigned, modified, supplemented
or amended in accordance with their respective terms.


 


1.1   “Affiliate” of a Person means another
Person controlled by, controlling or under common control with such
Person.  For purposes of this definition,
“control” means direct or indirect beneficial ownership of at least fifty
percent (50%) of the voting interest or equity of such Person or the ability
(whether directly or indirectly) to determine the policy or actions of any
entity on account of contract or other relationship.


 


1.2   “BESA’s
Drug/Polymer Composite Formulation” means Biolimus A9 combined with BESA’s
Polymer Coating in a composite formulation, which composite formulation
provides local delivery of Biolimus A9 and is described in Exhibit 1.2.


 


1.3   “BESA’s Indemnified Persons” means
BESA, its Affiliates and their respective directors, officers, shareholders,
employees and representatives.


 


1.4   “BESA Items” means the following, to
the extent provided under this Restated Agreement: Biolimus A9, BESA’s Polymer
Coating and BESA’s  Drug/Polymer
Composite Formulation.


 


1.5   “BESA’s
Polymer Coating” means a biodegradable polymer coating proprietary to BESA
that can be used as part of a composite to provide local delivery of a drug on
a Stent.


 


1.6   “Biolimus A9” means (a) the
Rapamycin derivative synthesized by or proprietary to BESA or its Affiliates,
which was used by Biosensors Singapore in its STEALTH trial in Europe and
either (i) further described in the applicable New Drug Application or
technical dossier for CE Mark submission, or (ii) disclosed in or covered
by the claims of the Licensed Patents; or (b) any prodrugs and
metabolites, and all esters, salts, acids, hydrates, solvates, polymorphs, and
isomers of any of the above.


 


2

















 


1.7   “CE Mark” means the declaration of
conformity according to Medical Device Directive 93/42/EEC, after receipt of
all approvals necessary or required for the commercialization in the European
Union of a medical device product.


 


1.8   “Confidential Information” has the
meaning set forth in Section 10.1.


 


1.9   “Coated Stents” means XTENT’s Stents
marketed, developed or sold by XTENT and coated with BESA’s Drug/Polymer
Composite Formulation or (if permitted according to the terms of this Restated
Agreement) BESA’s Polymer Coating or Biolimus A9.


 


1.10   “Enforcement Limitations” has the
meaning set forth in Section 6.2.


 


1.11   “Excluded Technology” means (i) any
proprietary compound of BESA or its Affiliates other than BESA’s Polymer
Coating, BESA’s Drug/Polymer Composite Formulation and Biolimus A9; (ii) any
other proprietary coating of BESA for Stents, other than BESA’s Polymer
Coating; (iii) except as set forth in subsection (iv) below, know-how
to the extent related to any proprietary Stent of BESA or its Affiliates and
not related to BESA’s Drug/Polymer Composite Formulation, BESA’s Polymer
Coating or  Biolimus A9; and (iv) know-how
to the extent related to the manufacture, production or synthesis of Biolimus
A9.


 


1.12   “FDA” means the U.S. Food and Drug
Administration.


 


1.13   “GAAP” means
generally accepted accounting principles, consistently applied.


 


1.14   “Inventions” shall
refer to any new or useful art, discovery, contribution, finding or
improvement, whether or not patentable, and all related know-how.  Inventions include, but are not limited to,
all trade secrets, designs, discoveries, formulae, processes, manufacturing
techniques, improvements and ideas.


 


1.15   “Licensed Assets”
means Licensed Patents and Licensed Know-How.


 


1.16   “Licensed Know-How”
means any information, concepts, data, know-how, manufacturing or testing
methods, processes, or improvements thereto owned or controlled by BESA or any
Affiliate of BESA as of the Original Effective Date or which were developed
prior to the Effective Date of this Restated Agreement which are necessary or
useful for using, obtaining regulatory approvals for, or selling BESA’s
Drug/Polymer Composite Formulation, BESA’s Polymer Coating or Biolimus A9 in
connection with XTENT’s Stents and XTENT’s Stent Systems.  Licensed Know-How specifically excludes
know-how to the extent comprised of or describing any Excluded Technology and
any know-how related to the manufacturing methods or processes for the
production of Biolimus A9 or BESA’s Polymer Coating.


 


3

















 


1.17   “Licensed Patents” means (i) those
certain patents, patent applications and invention disclosures owned or
controlled by BESA or any of its Affiliates as of the Original Effective Date
or during the term of this Restated Agreement, any claims of which are directed
to or cover Biolimus A9, BESA’s Polymer Coating, or BESA’s Drug/Polymer
Composite Formulation, or the use thereof, all of which filed as of the
Original Effective Date are set forth on Exhibit 1.17,
(ii) all patents that are continuations-in-part, substitutions,
confirmations, divisionals, reissues, registrations, re-examinations,
revalidations, extensions, foreign counterparts or are otherwise based on or
claim priority to the patents, patent applications and invention disclosures
referred to in subsection (i) hereinabove; and (iii) all patents and
patent applications covering, disclosing or directed to  the Licensed Know-How, but in the case of
each of (i) and (ii) above, only to the extent that claims or
portions of claims cover or are directed to BESA’s Drug/Polymer Composite
Formulation, Biolimus A9 or  BESA’s
Polymer Coating  or the use of any of the
foregoing, and specifically excluding any embodiments of a patented claim that
are directed to or cover Excluded Technology and are not directed to or do not
cover  (i) or (ii) above.


 


1.18   “Losses” means all
losses, damages, demands, claims, assessments, liabilities, payments and
obligations, and all expenses related thereto. 
Losses will include any reasonable legal fees and costs incurred by an
Indemnified Person in defense of or in connection with any alleged or asserted
liability, payment or obligation for which indemnity is provided under Article IX,
whether or not such Indemnified Person is made or becomes a party to any claim
or legal action.


 


1.19   “Material Adverse Effect” means any
change, effect, fact, event, occurrence, state of facts or development that,
individually or together with any other changes, effects, facts, events,
occurrences, states of fact or developments which materially and adversely
affects the ability of the applicable Party to perform its obligations under
this Restated Agreement.


 


1.20
  “Net
Sales” means the gross sales of Royalty Bearing Products by XTENT, XTENT’s
Affiliates and Sublicensees to third parties in a commercial sale, specifically
excluding transfers for purposes of clinical trials or evaluation and not for
sale, in each case less the amount actually allowed to such third parties for (a) allowances
on account of the rejection or return of products previously sold, (b) customary
trade discounts and rebates to customers to the extent actually allowed and
taken, (c) actual cost of transportation, insurance, shipping and handling
charges, (d) sales, excise, turnover and similar taxes and any duties and
other governmental charges imposed upon the importation, use or sale of Royalty
Bearing Products, and (e) reasonable provision for uncollectible accounts
in an amount not to exceed one percent (1%) of 
the gross sales of each such calendar year, consistently applied and in
accordance with GAAP.  If a Royalty
Bearing Product is sold as part of a larger bundle or kit that incorporates or
includes other products in addition to the Royalty Bearing Product, then Net
Sales will be computed using an average net selling price of the Royalty
Bearing Product sold separately or, if such average net selling price is
unavailable, it will be computed using only that part of 


 


4

















 


such sale as the Parties
reasonably agree is reasonably allocated to the value of the Royalty Bearing
Product as compared to the value of the larger bundle or kit sold without the
Royalty Bearing Product.


 


1.21   “Person” means any individual, corporation,
partnership, limited liability company, joint venture, estate, trust,
association, organization, labor union or other entity or governmental body,
agency or authority.


 


1.22   “Royalty Bearing Product” means a
Stent or Stent System sold by XTENT, an Affiliate of XTENT or a Sublicensee of
XTENT, and


 


(a)  (i) incorporating
BESA’s Drug/Polymer Composite Formulation, Biolimus A9 and/or BESA’s Polymer
Coating (if permitted hereunder) and/or (ii)  for which XTENT submitted
applications for market approval in any jurisdiction and which include BESA’s
confidential pre-clinical or clinical data related to BESA’s Drug/Polymer
Composite Formulation, BESA’s Polymer Coating and/or Biolimus A9, which data
has been provided by BESA to XTENT or directly to a regulatory authority
(collectively “Full Royalty-Bearing Product”), including that data which
has been cross-referenced by XTENT.


 


(b)  incorporating BESA’s
Polymer Coating (“Polymer-Only Royalty Bearing Product”) where XTENT is
utilizing a different drug with BESA’s Polymer Coating in the event of a Supply
Failure pursuant to Section 3.4 below; or


 


(c) 
incorporating Biolimus A9 (“Drug-Only Royalty Bearing Product”) where
XTENT is utilizing a different polymer with Biolimus A9 in the event of a
Supply Failure pursuant to Section 3.4 below.


 


1.23   “Stent”
means a device or graft that is implanted into a vessel to serve as
scaffolding.


 


1.24   “Stent
System” means a Stent mounted on a catheter.  Stent System shall not include any other
devices that may be supplied with the Stent other than the delivery catheter.


 


1.25   “Sublicensee”
means a permitted sublicensee or assignee of the applicable Party.


 


1.26   “Term Sheet”
means the non-binding term sheet [****] executed by XTENT and Occam.


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


5

















 


1.27   “XTENT’s
Indemnified Persons” means XTENT and its directors, officers, shareholders,
employees and representatives.


 


1.28   “XTENT’s
Licensed Field of Use” means any applications, procedures, processes or
other uses related to drug-eluting, commonly delivered Stents that are
delivered as a series of short stents on a delivery catheter wherein the
operator has the ability to select the number of short Stents as a portion of
the total number of stents in the series to be deployed, solely for use in coronary
and peripheral vascular applications.  
In Japan, “XTENT’s Licensed Field of Use” is further limited to treating
long lesions, multiple vessels or small vessels in coronary and peripheral
applications.  For purposes of clarity,
XTENT’s Licensed Field of Use does not include any application, procedure,
process or use related to drug-eluting stents that are not delivered as part of
a series of short Stents on a delivery catheter.


 


ARTICLE II




GRANT OF LICENSE


 


2.1     XTENT’s Licenses.


 


(a)   Subject to
the terms of this Restated Agreement, BESA hereby grants to XTENT, and shall
cause its Affiliates to grant to XTENT (if necessary to effectuate such grant)
under the Licensed Assets, a non-exclusive, royalty-bearing, worldwide license
to:


 


(i)  
import, export, use, sell, and offer for sale XTENT’s Stents utilizing,
incorporating or coated with BESA’s Drug/Polymer Composite Formulation, in each
case only in XTENT’s Licensed Field of Use;


 


(ii)  coat XTENT’s Stents with (1) BESA’s
Drug/Polymer Composite Formulation, or (2) subject to the conditions set
forth herein and only in the event  of a
Supply Failure, BESA’s Polymer Coating and another drug (subject to Section 2.3(b))
or with Biolimus A9 and another polymer;


 


(iii)  perform testing of the Coated Stents
either itself or by utilizing the services of a third party of XTENT’s
choosing, provided that (1) such testing is required for regulatory
submissions, market approval or lot release of the Coated Stents, and (2) any
third party performing such testing services has signed a non-disclosure
agreement with XTENT containing terms no less protective than the terms
contained in Section 10.1 hereof, the form of which has been approved by
BESA in advance;


 


(iv)  subject to the conditions set forth in
this Restated Agreement, purchase Biolimus A9 and/or BESA’s Polymer Coating
separately for the sole purpose of mixing BESA’s Drug/Polymer Composite
Formulation and coating XTENT’s Stents with such formulation for the import,
export, use and sale of XTENT’s Stents in XTENT’s Licensed Field of Use.


 


6

















 


(v)  
subject to the conditions set forth in this Restated Agreement and only
in the event of a Supply Failure, purchase Biolimus A9 and/or BESA’s Polymer
Coating separately and import, export, use, sell, and offer for sale XTENT’s
Stents utilizing, incorporating or coated with either (1) Biolimus A9
combined with another polymer or (2) BESA’s Polymer Coating combined with
another drug (subject to Section 2.3(b)), 
in each case, only in XTENT’s Licensed Field of Use.


 


For purposes of clarity, nothing contained in this
Restated Agreement shall be construed as granting to XTENT any rights to use
BESA’s Drug/Polymer Composite Formulation, Biolimus A9 and/or BESA’s Polymer
Coating on any Stent other than an XTENT Stent (as defined herein) within XTENT’s
Licensed Field of Use or to use Biolimus A9 on an XTENT Stent (or any other
Stent) without a polymer coating.


 


                     (b)   XTENT shall not sublicense any of its rights acquired
hereunder without the prior written consent of BESA, which consent may be
withheld in BESA’s sole discretion.


 


           2.2     This section has intentionally been left
blank.


 


           2.3     Diligence and Limited Exclusivity.


 


                     (a)   XTENT hereby agrees to use commercially
reasonable efforts to commercialize the Coated Stents, to conduct such tests
and trials and obtain such approvals, at its own cost, as may be necessary for
the sale of the Coated Stents in the United States and other markets at XTENT’s
option, and to maximize royalties therefrom.


 


                     (b)   Subject to Section 5.3,  Section 11.2, and Section 12.6,
during the term of this Restated Agreement, XTENT shall not make, use, sell or
offer to sell any drug eluting Stent using Rapamycin, or any Rapamycin
derivative other than Biolimus A9.


 


ARTICLE III




COATING AND PURCHASES OF FORMULATION


 


              
3.1    Coating of XTENT’s
Stents.  The Parties acknowledge that
commencing in or around August 2005, XTENT has been coating XTENT’s Stents
on its own behalf and has not been utilizing BESA or its Affiliates to perform
coating services. XTENT shall be solely responsible for the development of the
process it uses for coating XTENT’s Stents.


 


                     (a)  Formulation Technology
Transfer.  Within thirty (30) days of
the Effective Date of this Restated Agreement, the Parties shall agree upon a
plan for transferring from BESA to XTENT that information and Know-How
necessary to allow XTENT to mix Biolimus A9 and BESA’s Polymer Coating, using
the same processes and 


 


7

















 


methods used by BESA for XTENT, to produce BESA’s
Drug/Polymer Composite Formulation for coating on XTENT’s Stents.  The Parties shall make reasonable efforts to
complete such transfer within ninety (90) days of the Effective Date of this
Restated Agreement.


 


               3.2    Purchase Orders, Forecasts and Supply
Terms for BESA’s Drug/Polymer Composite Formulation.


 


                     (a)   Purchase Orders and Forecasts.  Commencing no later than the beginning of the
first calendar quarter after the Effective Date of this Restated Agreement and
continuing at the beginning of each calendar quarter thereafter, XTENT shall
provide a rolling forecast of the quantities of BESA’s Drug/Polymer Composite
Formulation, Biolimus A9, or BESA’s Polymer Coating which XTENT intends to
purchase during the following twelve (12) month period (the “Forecasts”),
by month.  The first six (6) months
of each Forecast shall be binding on XTENT and the balance shall be for
planning purposes.  In addition, XTENT
shall provide BESA with purchase orders for BESA’s Drug/Polymer Composite
Formulation, Biolimus A9 or BESA’s Polymer Coating (the “Purchase Orders”)
corresponding with at least the binding portion of each Forecast.  The Purchase Orders shall specify the amount,
by volume or weight, as applicable, of BESA’s Drug/Polymer Composite
Formulation, Biolimus A9 or BESA’s Polymer Coating which XTENT desires to
purchase from BESA and XTENT’s desired date of delivery, which in any case
shall not be less than thirty (30) days after the date on which the Purchase
Order is delivered to BESA unless agreed to in writing by BESA in advance. The
Purchase Orders shall also include delivery dates, lead times, shipping or
delivery instructions and other standard and customary terms.   Each such Forecast and Purchase Order shall
be subject to written acceptance by BESA, except that once the Forecast is
accepted,  BESA shall accept all Purchase
Orders corresponding to the volume or number of grams in the binding portion of
the Forecast for such months.  To the
extent any such Purchase Orders for any month exceed 100% of the Forecast issued
ninety (90) days prior to such month, BESA shall use its commercially
reasonable efforts to supply such excess quantities, but shall not be obligated
to do so.  Each Purchase Order and any
acknowledgment thereof shall be governed by the terms of this Restated
Agreement and the other provisions agreed to in writing in advance, rather than
any inconsistent terms which may be set forth in the Purchase Order or
acknowledgment, except for those terms specifying quantity, delivery dates,
shipping or delivery instructions and other general information not
inconsistent with the established terms. 
In the event of any shortage of capacity or material relating to BESA’s
Drug/Polymer Composite Formulation, Biolimus A9 or BESA’s Polymer Coating, BESA
shall allocate such resources to fill XTENT’s orders in the same proportion as
XTENT’s orders relate to orders from all customers of BESA and BESA’s own
requirements.  Such allocation does not
limit or reduce each Party’s obligations and rights under Section 3.4,
which apply regardless of such allocation.


 


8

















 


                    
(b)   Purchase Price for BESA Items.   XTENT’s
purchase price for BESA’s Drug/Polymer Composite Formulation, Biolimus A9 and
BESA’s Polymer Coating, shall be a sum equal to the Direct Costs (as defined
below) of BESA and/or its Affiliates for such BESA Items plus [****]percent
[****](%).  Direct Costs shall include
only direct material and labor costs (“Direct Costs”) calculated on a
quarterly basis.  Within sixty (60) days
after the end of each calendar quarter, BESA shall determine whether, as a
result of changes in BESA’s Direct Costs, there shall be an adjustment to the
purchase price, and shall provide written notice to XTENT thereof, including
the effective date of such change, describing the reasons for such change in
its Direct Costs, which adjustment shall be effective for all future services
after the effective date of such written notice.  BESA will document such Direct Costs on a
quarterly basis to XTENT’s reasonable satisfaction.  BESA will use its best efforts to
provide notice of any price increases to XTENT as soon as possible after
becoming aware of any increases in its Direct Costs.


 


(c)   Payment
Terms.   BESA shall tender invoices
to XTENT for all BESA Items purchased under terms of this Article III,
which invoices shall be due and payable no later than thirty (30) days after
the later of the date of invoice or date of shipment, whichever is earlier.


 


(d)    Shipping. All BESA Items to be supplied hereunder shall be
delivered to XTENT’s designated carrier Ex Works BESA’s plant (in accordance
with latest edition of INCOTERMS), or
at such other location determined by BESA, at which time risk of loss shall
pass to XTENT. Unless otherwise instructed by XTENT, Biosensors shall insure
each shipment with a reputable insurer for the full invoice price of such
shipment and shall invoice XTENT for the cost thereof. Such insurance shall
provide for coverage from the time the shipment is delivered at the carrier
until delivery to XTENT. All freight, insurance, and other shipping expenses,
as well as any special packing expense, shall be paid by XTENT.


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


9

















 


(e)   Acceptance
And Rejection Of BESA Items


 


                    (i)   Acceptance and Rejection. XTENT
shall inspect all shipments of BESA Items promptly upon receipt thereof. In the
event of any shortage, damage or discrepancy in or to a shipment of Products,
XTENT shall, within fifteen (15) business days after delivery to XTENT (the “Rejection
Period”), promptly report the same to BESA and furnish such written evidence or
other documentation as BESA may deem appropriate. BESA shall not be liable for
any such shortage, damage or discrepancy unless BESA has received notice and
substantiating evidence thereof from XTENT within the Rejection Period unless
it is determined that such shortage, damage or discrepancy occurred prior to
the delivery of the shipment to the carrier. Any Product not properly rejected
within the Rejection Period shall be deemed accepted. If any portion of a BESA
Item is shipped by XTENT or at XTENT’s request to a third party or used by
XTENT prior to expiration of the Rejection Period, in each case for purposes
other than acceptance testing or qualification of such portion, then that
portion shall be deemed accepted upon shipment or usage by XTENT. If the
substantiating evidence delivered by XTENT shall demonstrate to BESA’s
satisfaction that BESA is responsible for such shortage, damage or discrepancy,
BESA shall promptly deliver additional or substitute BESA Items to XTENT in
accordance with the delivery procedures set forth herein, but in no event shall
BESA or its Affiliates be liable for any additional costs, expenses or damages
incurred by XTENT, directly or indirectly, as a result of such shortage, damage
or discrepancy in or to a shipment.  As
soon as practicable after the execution of this Restated Agreement, the Parties
shall agree upon the acceptance criteria and acceptance test protocols to be
used for the BESA Items, which shall be set forth in a separate written
document executed by both Parties.  The
acceptance criteria and test protocols applicable to each purchase order shall
be the same as those of the previous purchase order unless changes are mutually
agreed-upon in writing in advance of such purchase order.  If acceptance testing by XTENT according to
the agreed-upon protocol indicates that any shipment fails to meet the
agreed-upon acceptance criteria, and XTENT delivers the results of such testing
to BESA within the Rejection Period, it shall be presumed that such shipment
has been properly rejected and the burden to prove otherwise shall shift to
BESA.  Within fifteen (15) business days
of receiving XTENT’s rejection, BESA shall communicate any disagreement with
such rejection to XTENT in writing and its reasons therefor, or the shipment
shall be deemed rejected.  XTENT may
respond with additional information to BESA within a reasonable time
thereafter, even if the Rejection Period has passed.  If after good faith efforts the Parties are
unable to resolve any disagreement regarding the rejection of a shipment within
sixty (60) days of rejection, the rejected product shall be submitted for
analysis to an independent laboratory mutually agreed to by the parties. The costs of
such analysis shall be borne by the Party against whom the discrepancy is
resolved..  Fulfilment of any purchase orders issued by
XTENT shall not be delayed due to a 


 


10

















 


disagreement or testing in
connection with any other shipment, unless independent third party testing
indicates that XTENT’s  handling,
storage, testing methods or acceptance criteria do not conform with the
agreed-upon specifications, in which case shipments shall resume promptly upon
XTENT’s written notification to BESA that it has revised its testing methods
and/or acceptance criteria to conform to such specifications.


 


        (ii)   Method of Rejection.  To reject a BESA Item, XTENT shall, within
the Rejection Period, notify BESA in writing or by fax of its rejection and
request that BESA provide a Returned Goods Authorization number (“RGA”) to
XTENT and XTENT shall otherwise comply with the procedures set forth by BESA at
that time. Within ten (10) days after receipt of the RGA number, XTENT
shall return to BESA, or such entity designated by BESA, the rejected Product,
freight prepaid, in its original shipping carton with the RGA number displayed
on the outside of the carton. Provided that BESA has provided an RGA to XTENT,
BESA reserves the right to refuse to accept any rejected BESA Items that do not
bear an RGA number on the outside of the carton. As promptly as possible, but
no later than thirty (30) working days after receipt by BESA of properly
rejected BESA Items, BESA shall, at its option, either replace the BESA Item(s) or
credit XTENT therefor and shall credit XTENT for the shipping costs incurred by
XTENT in returning the same to BESA. BESA shall pay the shipping charges back
to XTENT for properly rejected BESA Items; otherwise XTENT shall be responsible
for the shipping charges for any shipment of replacement BESA Items to
XTENT.  If replacements of the rejected
BESA Items are then not available, BESA shall use commercially reasonable
efforts to obtain such BESA Items as quickly as possible and will keep XTENT
informed of the plan for  fulfilling its
responsibilities hereunder.


 


11

















 


3.3    Other
Services.  At the request of XTENT
and subject to the further approval of BESA or its designee, which shall be
subject to BESA’s sole discretion, BESA may make available to XTENT  other laboratory services which may be
required by regulatory authorities to obtain regulatory approvals (collectively
“Laboratory Services”).  Such
Laboratory Services shall be charged to XTENT at BESA’s (or its designee’s)
Direct Cost plus [****]. If XTENT requests Laboratory Services from BESA and
BESA agrees to provide the services, BESA or its designee shall provide a price
quotation based on BESA’s estimated direct cost costs plus [****] and proposed
delivery schedule for the performance of such services. Alternatively, XTENT
may use any third party it may choose to perform such Laboratory Services and
BESA shall provide reasonable assistance to XTENT and any information under
BESA’s control (excluding confidential information of a third party) that is
related to the analysis of processes and studies for BESA’s Drug/Polymer
Composite Formulation, Biolimus A9 or BESA’s Polymer Coating, but only to the
extent such information is necessary for testing required for obtaining
regulatory approval, for lot acceptance of the BESA Items, or for lot release
of XTENT’s Stents, subject to the confidentiality terms included in this
Restated Agreement.  Testing
responsibilities and the provision of data from BESA to XTENT are further
addressed in Article V.


 


3.4    XTENT’s
Rights in the Event of a Supply Failure.


 


                        (a)   In the event BESA and/or its Affiliates fail
to fill at least [****] percent ([****]%) of XTENT’s orders for BESA’s
Drug/Polymer Composite Formulation, Biolimus A9 or BESA’s Polymer Coating that
it is required to fulfill pursuant to Section 3.2 above over a period of
[****], XTENT may provide written notice to BESA of such failure. Provided that
XTENT is not in default hereunder, the parties shall meet promptly after XTENT
provides such notice to negotiate in good faith and agree on a plan for BESA to
begin fulfilling XTENT’s orders in a timely manner.  If BESA is unable to cure such default within
[****]days after receipt of such notice, a “Supply
Failure” shall be deemed to have occurred.  After the occurrence of a Supply Failure,
XTENT may exercise the licenses under Sections 2.1(a)(ii) and 2.1(a)(v) to
coat or otherwise incorporate with XTENT Stents either BESA’s Polymer Coating
and another drug (subject to Section 2.3(b)), or Biolimus A9 and another
polymer, for the remaining term of this Restated Agreement; provided however,
that if BESA is able to cure the Supply Failure within [****] months after the
occurrence of the Supply Failure, then XTENT shall resume purchasing the BESA
Items from BESA.


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


12

















 


                        (b)    In addition to the foregoing, in the event
BESA fails to fill at least [****]percent ([****]%) of XTENT’s orders for BESA’s
Drug/Polymer Composite Formulation, Biolimus A9 or BESA’s Polymer Coating that
it is required to fulfill in any 90-day period, XTENT may provide written
notice to BESA of such failure.  If BESA
is unable to cure such default within [****]days after receipt of such notice
(the “Cure Period”) and XTENT is not in material default under this Restated
Agreement, then BESA will be required to pay XTENT the sum of [****]Dollars
($[****]) per month for each calendar month after the expiration of the Cure
Period in which BESA fails to fill at least [****]percent ([****]%) of the sum
of (i) the quantity(ies) specified in XTENT’s orders during such calendar
month, and (ii) the aggregate quantity that has not been delivered
pursuant to previous orders prior to such calendar month.


 


                        (c)    When determining whether there has been a
Supply Failure, BESA shall not be required to increase the volume of BESA Items
supplied in any given month in excess of [****]percent ([****]%) above the
average volume over the immediately preceding two-month period.


 


                        (d)   In the event that BESA is prevented from
fulfilling any XTENT purchase order as a result of an inspection, order or
other action by a municipal, county, state or federal court or government
agency, BESA shall promptly notify XTENT of such situation and provide XTENT
with a copy or summary of such action and BESA’s plan  for resuming shipments, if such shipment is
possible.  If in BESA’s reasonable
estimation such shipments will not be resumed for at least ninety (90) days
from the date of such action, if legally permitted, BESA shall make
commercially reasonable efforts to make arrangements with its suppliers to ship
BESA Items directly to XTENT as soon as possible after the date of such order
or action and during the period in which BESA is prevented from selling BESA
Items directly to XTENT.  If such direct
shipment is not reasonably possible, BESA shall promptly provide an explanation
to XTENT of the reasons therefor and its plan for resuming shipments.


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


13














 


ARTICLE IV




PAYMENTS


 


                4.1    Payments.   In consideration of the licenses granted by
Occam under the Original Agreement, XTENT delivered to Occam the following:


 


                       
(a)      A cash payment of
[****]Dollars ($[****]) as an initial licensing fee; and


 


                       
(b)      [****]([****]) shares of
common stock of XTENT, pursuant to XTENT’s standard stock purchase agreement,
all of which were fully paid and non-assessable.


 


                4.2    Royalties.


 


                       
(a)    Royalty for Full
Royalty Bearing Products. For the Full Royalty Bearing Product (which is
not a Drug-Only or Polymer-Only Royalty Bearing Product as defined in Sections
1.22(b) and (c) above), XTENT will pay to BESA a royalty equal to
[****]percent ([****]%) of the aggregate Net Sales of such Full Royalty Bearing
Products by XTENT, its Affiliates and/or its permitted Sublicensees.  For purposes of clarity, BESA’s sole
remuneration with respect to Royalty Bearing Products not transferred in a
commercial sale including those used in clinical trials or for evaluation
purposes shall be the amounts paid pursuant to Article III.


 


                       
(b)    Royalty For
Drug-Only Royalty Bearing Products and Polymer-Only Royalty Bearing Products.  For Drug-Only Royalty-Bearing Products or
Polymer-Only Royalty Bearing Products (as defined in Sections 1.22(b) and (c) above)
which may be sold in the event of a Supply Failure, XTENT will pay to BESA a
royalty in an amount equal to [****]of the amount calculated under subsection 4.2
(a) above; provided, however, that if and when any  Stent utilizing BESA’s Drug/Polymer Composite
Formulation or  either Biolimus A9 or
BESA’s Polymer Coating has been approved for sale in the US, Europe or Japan,
the full royalty to be paid under Subsection 4.2(a) shall be payable by
XTENT for Drug-Only Royalty Bearing Products and Polymer-Only Royalty Bearing
Products and the reduced royalty shall no longer be applicable.


 










CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


14

















 


                       
(c)    Royalty Reductions.
Notwithstanding the foregoing subsections 4.2(a) and (b), XTENT may reduce
the royalties payable under subsection 4.2 (a) or (b) as
follows:  In the event that it is
determined by a court of competent jurisdiction or if XTENT determines and BESA
reasonably agrees that XTENT must pay royalties for a license to a third party
for use of Biolimus A9, BESA’s Polymer Coating, or BESA’s Drug/Polymer
Composite Formulation in order to commercialize Coated Stents, XTENT may deduct
from the royalties otherwise due to BESA the sums required to be paid to such
third party(s), up to a maximum of [****]percent ([****]%) of  the royalties that otherwise would be due
from XTENT, its Affiliates and/or its permitted Sublicensees in the area
covered by such licenses.


 


                        (d)    Annual Minimum Royalty.  Commencing with the calendar year in which
XTENT Stents first receive a CE-Mark, FDA or MHLW approval and for each
calendar year thereafter so long as this Restated Agreement remains in force
and effect, XTENT shall pay a minimum annual royalty to BESA in the sum of
[****]dollars ($[****]) (the “Minimum Annual Royalty”); provided that in
the first year after such approval, the Minimum Annual Royalty will be prorated
for the number of months during which such approval is effective.  In the event that in any calendar year the
royalties paid for such year are less than [****]dollars ($[****]), then BESA
shall provide written notice to XTENT of the shortfall.  XTENT shall pay BESA the amount of the
shortfall within forty (40) days after such notice; if XTENT does not pay the
amount of the shortfall, then BESA may terminate this Restated Agreement and
the licenses granted hereunder upon twenty (20) days’ additional written notice
to XTENT.


 


                       
(e)    Royalty Obligation.   The obligation to pay royalties hereunder
will arise upon the sale by XTENT, its Affiliates or its Sublicensees, if any,
to third parties.   Sublicense Royalties
due will be deemed to accrue when Royalty Bearing Products are sold to such
un-Affiliated third party, regardless of when payment has been received
therefor.  The obligation to pay
royalties to BESA will be imposed only once with respect to the same unit of
Royalty Bearing Product.


 










CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


15

















 


                        (f)    Payment of Royalties.  All royalty amounts payable to BESA pursuant
to this section will be paid quarterly within thirty (30) days following the
completion of the applicable calendar quarter, will be made in United States
Dollars and will be calculated in the currency of the sale and then converted
into United States Dollars at the conversion rate existing in the United States
(referencing the “U.S. dollar noon buying rates” or its equivalent) published
in the Wall Street Journal on the last working day of each period during which
royalties are calculated, net of applicable exchange related charges.  Each royalty payment will be accompanied by a
statement from XTENT showing total Net Sales, the applicable Royalty Rate and
the total royalty payment owing.


 


                       
(g)    Audit.  No more than twice in any twelve (12) month
period, BESA shall have the right to audit the records of XTENT pertaining to
the sale of Royalty Bearing Products. 
XTENT will provide BESA and its representatives with access to the
records during reasonable business hours, to check, at BESA’s expense, the
royalties due under this Restated Agreement. BESA will give XTENT written
notice of its election to audit the records related to the royalties due not
less than ten (10) business days prior to the proposed date of review of
XTENT’s records by BESA’s representatives. 
XTENT will maintain sufficient records to permit the audit for five (5) years
after the completion of each respective reporting period.  XTENT will prepare its records and reports
according to GAAP.  Upon completion of
any audit, the auditors will report to BESA the amount of the discrepancy in
payment, if any, and BESA will promptly provide a copy of the results to
XTENT.  If an audit reveals an underpayment
or overpayment by XTENT, XTENT will pay, or BESA will refund or credit XTENT,
as applicable, the amount due.  XTENT
may, within sixty (60) days after receipt of the first audit, in good faith
challenge the results of the audit by providing written records consistent with
its challenge, or by having a separate audit conducted by an independent third
party, at XTENT’s own cost.  If an audit
reveals an underpayment of more than five percent (5%), XTENT will pay all of
BESA’s costs associated with the audit and interest on the underpayment
computed from the date of such underpayment at an annual rate equal to the U.S.
prime rate as published in The Wall Street Journal as of the date of such
underpayment plus two percent (2%), or the maximum rate allowed by applicable
law, if less.


 


                4.3    Payment Procedures; Taxes and
Withholdings.  Each amount required
to be paid under this Restated Agreement to BESA will be paid via wire transfer
to an account designated in writing by BESA.   XTENT shall pay, and shall
indemnify and hold BESA harmless from, all taxes, duties and levies directly
imposed by all foreign, federal, state, local or other taxing authorities
(including, without limitation, export, sales, use, excise, and value-added
taxes) based on transactions or payments under this Restated Agreement, other
than taxes imposed on BESA’s net income.   All amounts payable hereunder
by XTENT shall be paid without deduction or withholding for or on account of
BESA; provided, however, that if XTENT is required by law to deduct or withhold
any taxes, levies, or charges in respect of any amounts payable to BESA
hereunder, XTENT shall pay the relevant taxation authority the minimum amounts
necessary to comply with 


 


16

















 


applicable law in a timely manner prior to the date on which
interest or penalties will attach thereto and shall pay to BESA such additional
amounts as may be necessary so that the net payments made to BESA after any
such deduction or withholding will be equal to the amount that BESA would have
received had no such deduction or withholding been required.  As a condition of XTENT paying the foregoing
amounts without deduction for taxes, however, BESA shall provide to XTENT all
necessary forms, statements, certifications or other documents as are required
to qualify for a reduction in or exemption from withholding, including but not
limited to filing a form W8BEN prior to the date the first royalty payment is
due.  BESA and XTENT shall reasonably
cooperate in obtaining such reduction or exemption from withholding.


 


ARTICLE V




TESTING and CLINICAL TRIALS


 


                5.1    Testing.  XTENT shall be responsible, at its own
expense, for conducting all necessary testing, performing proper clinical
studies and trials and preparing and filing all required submissions to the
appropriate regulatory agencies in connection with the Coated Stents.  XTENT shall be responsible for performing
such tests and the processing, manufacturing, packaging and provision of XTENT’s
Stents and XTENT Stent Systems in accordance with all applicable laws and
regulatory standards (including current good manufacturing practices or the
equivalent).


 


                       
(a)    XTENT’s Access to Third Parties.  BESA agrees that XTENT may, without any
additional payment to BESA, use any third party testing facility (including
third parties previously utilized by BESA or its Affiliates prior to the
execution of this Restated Agreement) and any testing methods or processes that
XTENT may elect for such testing, studies and trials, regardless of BESA’s
ownership of such methods or processes; provided, however, that (i) XTENT
shall have no right to use any methods or processes developed by BESA or its
Affiliates after the Effective Date of this Restated Agreement; (ii) it is
not the intent of the Parties to expand the scope of the license granted under
this Restated Agreement; (iii) nothing contained herein shall be construed
as a transfer or assignment of any of the intellectual property rights of BESA,
its Affiliates or licensors in any methods or processes owned or held by them;
and (iv) any third party performing such testing services shall be
required to execute a non-disclosure agreement with XTENT containing terms no
less protective than the terms contained in Section 10.1 hereof, the form
of which has been approved by BESA in advance. 
XTENT shall provide a copy of such agreement to BESA promptly after the
execution thereof.  Upon XTENT’s request
after reasonable advance notice to BESA and receipt of a copy of the executed
non-disclosure agreement referenced in subsection (iv) above, BESA shall
provide to XTENT or its designated third party such information with respect to
the BESA Items as reasonably requested by XTENT to enable it to conduct such
testing.  BESA will also provide
necessary authorizations, information and material including BESA’s
Drug/Polymer Composite Formulation, Biolimus A9 and BESA’s Polymer Coating to
such third party to enable testing required for regulatory approvals, future analytical method development, or lot release
testing. In the event any testing required by 


 


17

















 


a regulatory agency for approval of XTENT’s Stents requires
the use of samples of BESA’s Stents or Stent Systems, BESA will reasonably
cooperate with XTENT to accomplish the required testing, or BESA may elect to
perform such testing itself or through a third party, in either case according
to the protocols and schedule reasonably requested by XTENT and agreed to by BESA.
XTENT shall control the testing of its own Stents and the protocols shall be
mutually agreed upon by the Parties. 
BESA shall have the right to charge XTENT for all of such information,
materials and labor associated with such testing performed by BESA or its
Affiliates based on the Direct Costs of BESA and its Affiliates plus
[****]percent ([****]%). Neither BESA nor its Affiliates shall be responsible
for any test methods or processes utilized by XTENT in performing the testing
hereunder, whether developed by BESA, its Affiliates or others.


 


                        (b)    BESA’s Access to XTENT’s Information.
 In
the event any testing required by a regulatory agency for approval of BESA’s
Stents requires the use of samples of XTENT’s Stents or Stent Systems, XTENT
will reasonably cooperate with BESA to accomplish the required testing, or
XTENT may elect to perform such testing itself or through a third party, in
either case according to the protocols and schedule reasonably requested by
BESA and agreed to by XTENT. BESA shall control the testing of its own Stents
and the protocols shall be mutually agreed upon by the Parties.  XTENT shall have the right to charge BESA for
all of such information, materials and labor associated with such testing
performed by XTENT based on the Direct Costs of XTENT plus [****].


 


                5.2    BESA’s Responsibility.  At BESA’s own expense, it shall perform
stability testing on Biolimus A9, BESA’s Polymer Coating, and BESA’s
Drug/Polymer Composite Formulation as used within the BESA Items.  In addition, BESA shall undertake any other
necessary testing which is required to develop a drug master file (“DMF”), a
master application file (“MAF”) or equivalent technical dossier sufficient to
support an Investigational New Drug Application, Investigational Device
Exemption, Premarket Application, or equivalent regulatory filing in the United
States, Japan and Europe and to address any deficiencies or questions in such
filings identified by the relevant agencies as required for regulatory approval
to market XTENT Stents (collectively BESA’s Testing Obligations”). Any such
assistance, if rendered by BESA or its Affiliates, shall be charged to XTENT at
the Direct Costs of BESA and its  
Affiliates plus [****] ([****]%). In addition, such assistance shall
require advance discussions and written agreement between BESA and XTENT on the
protocols and testing timeframes needed by XTENT.


 


                        (a)   BESA shall keep XTENT generally informed of
the progress of any regulatory actions related to the BESA Items and shall
provide updates at least once per calendar quarter, and more often if
necessary.


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND  EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.


 


18

















 


                       
(b)   If any such testing
required to be done by BESA is done by a third party on BESA’s behalf or under
license from BESA or one of its Affiliates, then with respect to any testing or
clinical data developed or gathered in such testing and relevant to obtaining
approvals of XTENT’s Stent or the XTENT Stent System, BESA shall utilize
reasonable efforts to obtain access to the data which may be necessary for
XTENT pursuant to Section 5.8.  To
the extent such information is subject to confidentiality obligations to a
third party and to the extent BESA obtains permission from such third party to
give access to such information, BESA shall provide the data only to the
applicable regulatory bodies without disclosure to XTENT of such third party
confidential data.


 


                       
(c)   If BESA considers the
results of BESA’s Testing Obligations confidential, BESA shall have the right
to provide the data directly to the applicable regulatory authority without
disclosure to XTENT.


 


                       
(d)   Neither BESA nor any of
its Affiliates shall have any obligation to provide to XTENT the results of any
future work performed by any third party testing facility after the Effective
Date of this Restated Agreement, except to the extent such results are part of
BESA’s Testing Obligations (the results of which may be submitted directly to
regulatory agencies).


 


                5.3    If a Stent using BESA’s Drug/Polymer
Composite Formulation, Biolimus A9 or BESA’s Polymer Coating has not been
approved by the MHLW, the FDA or a notified body for CE Mark approval by February 1,
2008 , or if at any time BESA abandons development, testing or
commercialization of Biolimus A9 or the Drug/Polymer Composite Formulation,
then, at XTENT’s option, (i) XTENT may terminate this Restated Agreement
with thirty (30) days written notice to BESA; (ii) at XTENT’s option,
notwithstanding Section 2.3(b), XTENT shall have the right to use
Rapamycin or other analogs thereof on XTENT’s Stents for purposes of in vitro
or in vivo preclinical studies; provided, however, that if an approval of a
Stent utilizing BESA’s Drug/Polymer Composite Formulation, Biolimus A9 and/or
BESA’s Polymer Coating is granted by the MHLW, FDA, or a notified body for CE
Mark within twelve (12) months from the Effective Date of this Restated
Agreement, the foregoing right shall terminate and Section 2.3(b) shall
remain in force; or (iii) if no such approval is obtained within twelve
(12) months from the Effective Date of this Restated Agreement, then this
Restated Agreement will continue pursuant to the licenses under Sections 2.1(a) and
(b), but Section 2.3(b) shall terminate.


 


                5.4    Payment for Testing, Trials and
Submissions.  XTENT shall be solely
responsible for all costs and expenses in connection with the conduct of all
necessary studies, testing and trials in connection with the Coated Stents and
the preparation and filing of submissions to the necessary regulatory bodies. XTENT will have the sole right to apply for
regulatory approvals for XTENT’s Stents and XTENT Stent Systems in all
jurisdictions.


 


19

















 


                5.5    Regulatory Agencies and Interactions.  The parties understand and agree that XTENT,
itself or through its agents, shall have the sole right to correspond with and
submit regulatory applications and other filings to the FDA, MHLW or other
regulatory agencies to obtain approvals to import, export, sell or otherwise
commercialize the Coated Stents alone or with other products or services
(collectively, “Approvals”) as XTENT deems useful or necessary.  Accordingly, except as otherwise required by
law, BESA shall not correspond directly with the FDA, MHLW or any other
regulatory agency relating to the process of obtaining Approvals or any
obtained Approval for the Coated Stents, without XTENT’s prior permission,
except to the extent it is submitting the DMF or MAF to the applicable
regulatory authority.


 


                5.6    If BESA desires to make any significant
change in its materials, suppliers, manufacturing methods, locations or
equipment, specifications, acceptance tests or criteria, quality systems or
other related areas affecting BESA Items, BESA shall provide XTENT with
information regarding such significant change in advance thereof and an
opportunity for XTENT to discuss the proposed changes with BESA. BESA shall
only make significant change(s) after (i) regulatory approval for
such change(s) has been obtained as it relates to XTENT’s Stents or (ii) BESA
confirms after consultation with XTENT that approval of the change(s) is
not required.  For the purposes of this
section, “significant change” means any change of which Xtent needs to be
informed due to applicable legal or governmental requirements, any change
clearly noticeable on the packaging of BESA Items, or any change that would
have a potential effect on XTENT’s operating procedures or regulatory filings.


 


                5.7    Reporting.  Pursuant to the FDA’s, the MHLW’s, or any
other applicable regulatory agency’s regulations and policies, XTENT may be
required to report to such regulatory agency information that reasonably
suggests that the Coated Stents may have caused or contributed to the death or
serious injury, and BESA may be required to report to such regulatory agency
information that reasonably suggests that the BESA Items may have caused or
contributed to the death or serious injury. 
Accordingly, a Party reporting such information to such a regulatory
agency shall inform the other Party of any such information promptly after
becoming aware of it so that the other Party can comply with its own reporting
requirements.


 


                5.8    Information.


 


                        (a)   BESA shall promptly provide to XTENT or
directly to the regulatory agency for cross-reference by XTENT, all written and
other information in BESA’s control (excluding confidential information of
third parties) that is necessary for XTENT to apply for, obtain and thereafter
maintain Approvals (as defined in Section 5.5) for the Coated Stents in
Europe, Japan and the United States, including, without limitation, information
relating to the facilities at which the BESA Items are manufactured, processed
or packaged, and information about process, methodology or components used in
the manufacture, processing, or packaging of BESA Items. If at BESA’s election,
the information is provided directly from BESA or its Affiliates to the
respective regulatory agencies, then such information shall be provided in the
format required or requested by each agency, which may include one or multiple
of the following formats:


 


20

















 


                      (i)   A DMF (Biolimus A9 information/pre-clinical
and clinical pharm-tox testing).  The DMF
will be referred to an eDMF in CTD format. 
The open part of the eDMF will be provided directly to XTENT for use in
Regulatory applications.


 


                      (ii)   An IND (Biolimus A9 information/pre-clinical
and clinical pharm-tox testing).   This
DMF will be referred to as an eDMF in CTD format.


 


                      (iii)   A DMF or MAF (Biolimus A9 and PLA formulation
specific to XTENT).


 


                       
(b)   For items (i) through
(iii) above, BESA will also provide directly to XTENT a “Right to
Reference” letter for inclusion in the XTENT regulatory applications.


 


                       
(c)   The timeline for
submittal by BESA or its Affiliates of required files in connection with XTENT’s
regulatory applications must be agreed upon no less than sixty (60) days in
advance of XTENT’s desired submission date. 
If deficiencies in the filings are identified by the relevant regulatory
agency, BESA or its Affiliates will (i) provide an action plan to XTENT
within thirty (30) days of receiving written notice of the deficiency outlining
how and when it will respond; and (ii) respond to the regulatory agency as
soon as reasonably practicable, but in any event prior to any applicable
deadline set by the relevant agency or prescribed by rule or statute
unless BESA notifies XTENT that it cannot reasonably comply with such deadline.


 


                       
(d)   Without limiting the
provisions of this Section 5.8, BESA and XTENT agree to meet at least once
per quarter at which time BESA shall inform XTENT when any information provided
hereunder is no longer current or no longer reflective of current practices
related to processing, manufacturing, packaging and performing the BESA Items,
and shall provide updated information to XTENT.


 


                       
(e)   For avoidance of doubt,
to the extent such the information provided to XTENT under this Section 5.8
is Confidential Information of BESA, its Affiliates or any third parties, then
the same shall be subject to the provisions of ARTICLE X below.


 


ARTICLE VI




REPRESENTATIONS AND WARRANTIES OF
BESA


 


                BESA
represents and warrants to XTENT as follows:


 


                6.1    Organization of BESA.  BESA is a corporation duly organized, validly
existing and in good standing under the laws of Switzerland. BESA has full
power and authority to own, lease and operate its properties and to conduct its
business in the manner and in the places where such properties are owned or
leased or its business is conducted.


 


21

















 


                6.2    Authorization of Transaction.  BESA has full corporate power and authority
to execute, deliver and perform this Restated Agreement and to carry out the
transactions contemplated herein.  All
necessary actions, corporate or otherwise, have been taken by BESA to authorize
and approve the execution, delivery and performance of this Restated Agreement
and the transactions contemplated herein, and this Restated Agreement is the
legal, valid and binding obligation of BESA, enforceable against BESA in
accordance with its terms, except to the extent enforceability may be limited
by applicable bankruptcy, reorganization, insolvency, moratorium or other
similar laws from time to time in effect affecting creditors’ rights generally
or by principles governing the availability of equitable remedies
(collectively, “Enforcement Limitations”).


 


                6.3    No Conflict With Obligations and Laws.  Neither the execution, delivery and
performance of this Restated Agreement, nor the performance of the transactions
contemplated by this Restated Agreement, will: (a) constitute a breach or
violation of any provision of BESA’s charter documents or by-laws; (b) to
the knowledge of BESA, require any authorization, approval, consent or waiver
of any governmental authority or third party; (c) constitute (with or
without the passage of time or giving of notice) a default under or breach of
any contract, agreement, instrument, commitment or obligation to which BESA is
a party or by which BESA is bound or give any Person the right to declare a
breach, accelerate, terminate, modify or cancel any right or obligation
thereunder, which in any such case would reasonably be expected to have a
Material Adverse Effect; or (d) to the knowledge of BESA, result in a
violation of any law, rule, regulation, administrative order or judicial order,
decree or judgment, which in any such case would reasonably be expected to have
a Material Adverse Effect.


 


                6.4    Licensed Patents.  Exhibit 1.17
sets forth a complete and correct list of all issued patents, patent
applications and invention disclosures currently owned by BESA or licensed by
BESA from one or more of its Affiliates related to Biolimus A9, BESA’s Polymer
Coating, and BESA’s Drug/Polymer Composite Formulation. [****]


 


                6.5   Finder’s Fees.  BESA has not incurred nor become liable for
any broker’s commission or finder’s fees relating to or in connection with the
transactions contemplated by this Restated Agreement.


 


                6.6   Litigation.  BESA has received no notice of any, and BESA
has no knowledge of any, pending or threatened claim, action, suit, arbitration
or other proceeding pending or, to the knowledge of BESA, threatened against
BESA that will or would prevent or hinder the consummation of the transactions
contemplated by this Restated Agreement and to BESA’s knowledge there is no
outstanding court order, court decree or court stipulation applicable to BESA
that relates to this Restated Agreement or


 






CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[****], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


22

















 


affects the transactions contemplated by this
Restated Agreement  [****]


 


                6.7    Product Warranties.  BESA warrants and represents that:


 


(a)      Specifications.  All BESA Items provided hereunder shall be in
conformance with the specifications therefor and shall conform with the
information shown on the certificate of analysis provided for the particular
shipment;


 


(b)      cGMP.  All BESA Items provided hereunder will meet
all applicable regulatory requirements (including applicable cGMP regulations)
imposed by applicable regulatory agencies with respect to any Approval;


 


(c)      Compliance
with FFDCA.  None of the BESA Items
provided hereunder shall be adulterated or misbranded within the meaning of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et seq., as amended and in
effect of the time of shipment;


 


(d)      No
Encumbrance.  Title to all BESA Items
provided hereunder shall pass as provided herein free and clear of any security
interest, lien, or other encumbrance.


 


                6.8    Warranty Disclaimers.  BESA warrants that the BESA Items provided
hereunder shall be in conformance with the specifications.  EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE
VI, BESA MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR
IMPLIED, WITH RESPECT TO THE LICENSE GRANTED HEREUNDER OR THE PRODUCTS OR
SERVICES PROVIDED BY BESA.  EXCEPT AS
EXPRESSLY PROVIDED IN THIS ARTICLE VI, BESA HEREBY EXPRESSLY DISCLAIMS ANY
IMPLIED OR EXPRESS WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT, WITH RESPECT TO ANY
RIGHTS LICENSED HEREUNDER OR THE PRODUCTS OR SERVICES PROVIDED BY BESA. UNDER
NO CIRCUMSTANCES WILL BESA BE LIABLE TO XTENT OR ANY OF XTENT’S INDEMNIFIED
PERSONS FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES,
INCLUDING, WITHOUT LIMITATION, LOSS OF REVENUE OR ANTICIPATED PROFITS OR LOST
BUSINESS ARISING FROM ANY USE BY XTENT OR XTENT’S INDEMNIFIED PERSONS OF THE
LICENSED ASSETS EVEN IF A REPRESENTATIVE OF BESA HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES OCCURRING.


 






CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[****], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


23














 


ARTICLE VII


 


REPRESENTATIONS
AND WARRANTIES OF XTENT


 


XTENT hereby represents and warrants to BESA as follows:


 


                    7.1    Organization of XTENT.  XTENT is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware
with full power and authority to own, lease and operate its properties and to
conduct its business in the manner and in the places where such properties are
owned or leased or such business is conducted.


 


                    7.2    Authorization of Transaction.  XTENT has full corporate power and authority
to execute, deliver and perform this Restated Agreement and to carry out the
transactions contemplated herein.  All
necessary actions, corporate or otherwise, have been taken by XTENT to
authorize and approve the execution, delivery and performance of this Restated
Agreement and the transactions contemplated herein, and this Restated Agreement
is the legal, valid and binding obligation of XTENT enforceable in accordance
with its terms, except to the extent enforceability may be limited by
Enforcement Limitations.


 


                    7.3    No Conflict of Transaction with
Obligations and Laws.  Neither the
execution, delivery and performance of this Restated Agreement, nor the
performance of the transactions contemplated by this Restated Agreement, will: (a) constitute
a breach or violation of XTENT’s Articles of Incorporation or by-laws; (b) require
any authorization, approval, consent or waiver of any governmental authority or
third party; (c) constitute (with or without the passage of time or the
giving of notice) a default under or breach of any contract, agreement,
instrument, commitment or obligation to which XTENT is a party or by which
XTENT is bound, which in any such case would reasonably be expected to have a
Material Adverse Effect; or (d) result in a violation of any law, rule,
regulation, administrative order, judicial order, decree or judgment applicable
to XTENT, which in any such case would reasonably be expected to have a
Material Adverse Effect.


 


                    7.4   Finder’s Fee.  XTENT has not incurred nor become liable for
any broker’s commission or finder’s fees relating to or in connection with the
transactions contemplated by this Restated Agreement.


 


                    7.5    Litigation.  XTENT has received no notice of any, and
XTENT has no knowledge of any, pending or threatened claim, action, suit,
arbitration or other proceeding pending or, to the knowledge of XTENT,
threatened against XTENT that will or would prevent or hinder the consummation
of the transactions contemplated by this Restated Agreement and there is no
outstanding court order, court decree or court stipulation applicable to XTENT
that relates to this Restated Agreement or affects the transactions
contemplated by this Restated Agreement.


 


24

















 


                    7.6     Rights Limited to Field of Use.   XTENT will not practice any of the rights
in, to or under the Licensed Assets outside of XTENT’s Licensed Field of Use.


 


                    7.7    Option to Participate in Future
Financings.  BESA’s rights to
participate in any financing or offering of XTENT’s equity or debt securities
shall be governed by the First Amendment to the Original Agreement which shall
remain in full force and effect.


 


                    7.8     Issuance of XTENT Common Stock.   The issuance of XTENT shares to BESA
pursuant to Section 4.1(b) of the Original Agreement has been duly
approved by XTENT’s Board of Directors. 
All of the shares originally issued to Occam were fully paid,
non-assessable and freely transferable without restriction, except as set forth
in the stock purchase agreement under which Occam obtained such shares.  All of the agreements referenced in Exhibit A hereto shall remain in full force and effect
and shall not be modified by the terms of this Restated Agreement.


 


ARTICLE VIII




RIGHTS AND OBLIGATIONS SUBSEQUENT TO
EXECUTION OF


 


THIS RESTATED AGREEMENT


 


                8.1     Survival of Warranties.  All representations, warranties, agreements,
covenants and obligations contained in or contemplated by this Restated
Agreement will be deemed to have been relied upon by the other Party and will
survive the execution of this Restated Agreement, regardless of any
investigation and will not merge in the performance of any obligation by the
Parties hereto.


 


                8.2    This section has been intentionally left
blank.


 


                8.3    Licensed Patents; Prosecution and
Defense.


 


(a)      BESA
will have the sole right, but not the obligation, to prepare, prosecute and
maintain the Licensed Patents.  The cost
of such preparation, prosecution and maintenance of such Licensed Patents will
be paid by BESA.


 


(b)      Each
Party will promptly notify the other Party in writing of any infringement,
possible infringement, misappropriation or possible misappropriation, of any of
the Licensed Assets of which it becomes aware. 
BESA will have the sole right, but not the obligation, to enforce the
Licensed Assets at its own expense against third parties for infringement or
misappropriation of the Licensed Assets; XTENT may join such enforcement action
at its discretion and at its expense. Any recovery obtained as a result of such
enforcement of the Licensed Assets within XTENT’s Licensed Field of Use, by
settlement or otherwise, will be retained or paid over to BESA.  If BESA elects not to enforce the Licensed
Assets against any infringement or misappropriation, then BESA will notify
XTENT of such election within ninety (90) days after becoming aware of such
infringement or misappropriation, and XTENT will then have the right, but not 


 


25

















 


the obligation, to enforce the Licensed Assets at its own
expense.  Any recovery obtained as a
result of such enforcement conducted by XTENT will be retained or paid over to
XTENT; provided that for any portion of such recovery that was for future
sales, XTENT shall pay to BESA a royalty as if those future sales were Net
Sales under this Restated Agreement.


 


                8.4    Insurance.  At such time as XTENT commences human
clinical trials of Coated Stents, XTENT will obtain and maintain in force at
all times during the term of this Restated Agreement, and for a period of three
years thereafter, comprehensive general liability insurance, including product
liability insurance, in an amount not less than [****] in the aggregate with a
reasonable deductible per occurrence, not to exceed[****].  The limits of such policy shall be increased
to not less than [****] upon commercialization of XTENT’s Stents.  BESA or its successor to the rights and
obligations under this Restated Agreement, if any, will be designated as
additional insureds under such policy.  A
copy of such insurance policy (ies) shall be provided to BESA prior to the
commencement of human clinical trials of Coated Stents and shall be maintained
for the entire term of this Restated Agreement (including any renewals thereof)
and for a period of [****] years after the termination or expiration
hereof.  The policy shall provide for
thirty (30) day written notice to BESA (or its designee) by the insurer in the
event of any modifications, cancellation or termination thereof.


 


                8.5    Use of Word “Biolimus.”  So long as this Restated Agreement remains in
full force and effect and XTENT is performing its obligations hereunder, XTENT
shall have the limited right to use the name “Biolimus A9” in connection with
the marketing and promotion of the Coated Stents, as well as references to any
applicable clinical studies or other technical information made available by
BESA for XTENT’s marketing purposes. 
Except for the limited license set forth herein, XTENT shall not use the
name Biolimus A9, nor any other name or trademark of BESA and its Affiliates
for any other purpose without the prior written consent of BESA and then, only
as necessary in connection with XTENT’s performance hereunder.  Upon expiration or termination of this
Restated Agreement, XTENT shall cease using any name or mark belonging to BESA
or its Affiliates; provided, however, XTENT may continue to use the mark in
connection with the sale of remaining inventory of Coated Stents. The license
granted hereby conveys no right to register any name or mark of BESA or any of
its Affiliates.


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


26

















 


                8.6    Other BESA Programs.  XTENT acknowledges that BESA and its
Affiliates are engaged in the development and commercialization of drug-eluting
stents using active pharmaceutical compounds, including Biolimus A9 and other
compounds, and that BESA and such Affiliates may engage in research,
development and commercialization programs that may compete with XTENT’s own
programs.  Nothing in this Restated
Agreement shall be construed to prevent BESA and its Affiliates from engaging
in such research and development programs and neither BESA nor its Affiliates
shall have any obligation to XTENT in connection therewith, provided that BESA
is complying with its obligations under this Restated Agreement and any other
agreement between BESA (or any of its Affiliates) and XTENT (and any of its
Affiliates) regarding confidential information or proprietary rights.


 


                8.7    Improvements.


 


                        (a)   The Parties agree that, as between the Parties,
any Invention conceived or developed prior to the Effective Date of this
Restated Agreement and related specifically to processes for coating Stents
with BESA’s Drug/Polymer Composite Formulation, BESA’s Polymer Coating or
Biolimus A9, whether conceived or developed jointly by the Parties or solely by
either Party (“BESA’s Process Improvements”), and
the intellectual property rights therein and thereto, shall be the sole
property of BESA.  To the extent XTENT
becomes the owner of such Process Improvements, XTENT agrees to assign and
hereby assigns to BESA all of its right, title and interest in and to such
Process Improvements and the intellectual property rights therein and thereto;
provided, however, that nothing in this Section 8.7(a) shall require
XTENT to assign, license, or otherwise transfer rights in any Invention
conceived or developed by XTENT prior to the Original Effective Date.  As to any BESA Process Improvements invented
solely or jointly by XTENT after the Original Effective Date, BESA agrees to
grant XTENT, and hereby grants XTENT, for consideration herein acknowledged, a
non-exclusive, paid up, perpetual and irrevocable right and license, under all
of the intellectual property rights in BESA’s Process Improvements developed
prior to the Effective Date of this Restated Agreement, to make, use, sell and
offer to sell XTENT’s Stents, within XTENT’s Licensed Field of Use, and to
practice such method or process subject to all the terms and conditions
hereof.  The foregoing license shall survive
the expiration or termination of this Restated Agreement  It is understood that nothing in this Section creates
any additional license or right with respect to BESA Items beyond that set
forth in Article II hereof.


 


                        (b)   The Parties agree that, as between the
Parties, any Invention conceived or developed by XTENT solely or jointly with a
party other than BESA or its Affiliates subsequent to the Effective Date of
this Restated Agreement and related specifically to processes for coating XTENT’s
Stents with BESA’s Drug/Polymer Composite Formulation, BESA’s Polymer Coating
or Biolimus A9,  (“XTENT’s
Process Improvements”), and the intellectual property rights therein
and thereto, shall be the sole property of XTENT, unless such Process
Improvements were conceived or developed jointly with BESA or its Affiliates or
are based on or derived from the Confidential Information of BESA or its
Affiliates, in which case they shall remain the property of 


 


27

















 


BESA.  To the extent
BESA becomes the owner of such XTENT Process Improvements, BESA agrees to
assign and hereby assigns to XTENT all of its right, title and interest in and
to such XTENT Process Improvements and the intellectual property rights therein
and thereto.  As to Process Improvements
invented solely or jointly by BESA or which are based on or derived from the
Confidential Information of BESA, such Process Improvements shall be the sole
property of BESA and/or its Affiliates. 
To the extent XTENT’s Process Improvments relate to any BESA Item, XTENT
shall grant to BESA, and hereby grants BESA, for consideration herein
acknowledged, a non-exclusive, paid up, perpetual and irrevocable right and
license, under all of the intellectual property rights in such XTENT Process
Improvements, to make, use, sell and offer to sell any product, and to practice
any method or process.  The foregoing
license shall survive the expiration or termination of this Restated Agreement.  It is understood that nothing in this Section creates
any additional license or right with respect to BESA Items beyond that set
forth in Article II hereof.


 


                        (c) 
The Parties agree that all Inventions that are improvements of the BESA Items
(including Biolimus A9, BESA’s Drug/Polymer Composite Formulation, which
Inventions are determined to be such because they are derived from the
Confidential Information of BESA (“BESA-Related Improvements”),
and the intellectual property rights therein and thereto, shall be the sole
property of BESA (or such Affiliate of BESA, as applicable).  To the extent XTENT becomes the owner of any
BESA-Related Improvements, XTENT agrees to assign and hereby assigns to BESA
all of its right, title and interest in and to such BESA-Related Improvements
and the intellectual property rights therein and thereto.


 


                        (d) 
The Parties agree that all Inventions that are improvements of the XTENT Stent
or XTENT Stent System, which Inventions are determined to be such because they
are derived from the Confidential Information of XTENT (“XTENT-Related
Improvements”) and the intellectual property rights therein and
thereto, shall be the sole property of XTENT (or such Affiliate of XTENT, as
applicable).  To the extent BESA becomes
the owner of any XTENT-Related Improvements, BESA agrees to assign and hereby
assigns to XTENT all of its right, title and interest in and to such
XTENT-Related Improvements and the intellectual property rights therein and
thereto.


 


                        (e)   For any BESA-Related Improvements developed
or conceived solely or jointly by XTENT during the term of this Restated
Agreement that have application to the XTENT Stent or XTENT Stent System, BESA
agrees to grant and does hereby grant XTENT, for consideration herein
acknowledged, a non-exclusive paid up, perpetual and irrevocable  license, under all of BESA’s right, title,
and interest in and to such BESA-Related Improvements, to make, use, sell and
offer to sell XTENT Stents in XTENT’s Licensed Field of Use, and to practice
such method or process. The foregoing license shall survive the expiration or
termination of this Restated Agreement. 
It is understood that nothing in this Section creates any
additional license or right with respect to the BESA Items beyond that set
forth in Article II hereof.


 


                        (f) 
For any XTENT-Related Improvements developed or conceived solely or jointly by
BESA during the term of this Restated Agreement and related to the BESA 


 


28

















 


Items (i.e., BESA’s Drug/Polymer Composite Formulation, BESA’s
Polymer Coating or Biolimus A9), XTENT agrees to grant and does hereby grant
BESA, for consideration herein acknowledged, a non-exclusive, paid-up,
perpetual and irrevocable right and license, under all of XTENT’s right, title,
and interest in and to such XTENT-Related Improvements, to make, use, sell and
offer to sell any product, and to practice any method or process.  The foregoing license shall survive
expiration or termination of this Restated Agreement.


 


                8.8    XTENT Inspections.  While it is understood that nothing herein
provides XTENT the right to see, review, or inspect production processes
regarded as proprietary by BESA other than as expressly provided elsewhere
(including but not limited to Section 8.9), BESA shall permit XTENT to
review periodically BESA’s non-proprietary production and quality control
procedures and records and to visit BESA’s, or its permitted designee’s,
facilities at reasonable times with a representative of BESA present in order
to assure satisfaction of the requirements of this Restated Agreement.  Notwithstanding the foregoing, if an audit by
a regulatory authority is required or advisable in connection with obtaining
approval by such authority, then BESA shall cooperate with such inspection,
including as set forth in Section 8.9.


 


                8.9    Regulatory
Inspections.  BESA shall permit the
FDA, MHLW or other regulatory agencies to conduct inspections of its facilities
as such regulatory agencies may request, and shall cooperate with the FDA, MHLW
or such other regulatory agencies with respect to such inspections and any
related matters, in each case as related to any BESA Items.  BESA shall provide XTENT with prior notice
(when possible) of any such inspections, and shall keep XTENT informed about
the results and conclusions of each such regulatory inspection, including
actions taken by BESA to remedy conditions cited in such inspections. BESA
shall provide XTENT with copies of any written inspection reports issued by
such agencies and all correspondence between BESA and the relevant agency associated
with such inspection, including, but not limited to, FDA Form 483, Notice
of Observation, and all correspondence relating thereto, in each case relating
to  the Coated Stents.  XTENT and its regulatory consultants under
reasonable confidentiality requirements, shall have access to all quality
assurance and cGMP audits of BESA Items for the purpose of assessment of
regulatory compliance.


 


                8.10    Complaints.   If either Party receives material
complaints, claims, or similar communications from third parties (including,
without limitation, distributors, customers, hospitals, physicians and users,
collectively “Customers”) regarding any of the BESA Items licensed hereunder
which affect XTENT’s Stents, such Party shall promptly notify the other Party
of the contents thereof.   If XTENT is
unable to determine the cause underlying a Customer complaint regarding the
XTENT Stent Systems, XTENT may request that BESA assist XTENT in investigating
the problem and BESA shall promptly take all reasonable steps to investigate it
and shall notify XTENT of the results thereof as soon as practicable.


 


                        (a)    If the problem is in reference to XTENT
Stents or XTENT Stent Systems, XTENT shall be responsible for first conducting
all necessary investigations and shall promptly report the results thereof to
BESA.  If XTENT believes that the 


 


29

















 


problem is attributable to BESA Items, BESA will further
investigate the problem and if both parties determine that the problem is due
to a defect attributable to BESA, BESA shall take whatever steps are reasonably
necessary to correct the problem at its own cost. If the parties determine that
the problem is due to a defect attributable to XTENT, XTENT shall take whatever
steps are reasonably necessary to correct the problem at its own cost.


 


                        (b)    XTENT will bear the cost of repairing or
replacing all defective or non-conforming XTENT Stents and XTENT Stent Systems
unless the parties determine that the problem is attributable to BESA. XTENT
shall also be responsible for complaints arising from or attributable to the
acts or omissions of XTENT’s distributors and sales agents.


 


                8.11    Recalls.  XTENT shall have the right to recall XTENT
Stents or XTENT Stent Systems sold under this Restated Agreement if it is
determined to be necessary or upon the direction of the competent and/or
government authorities.  If the parties
determine that the product failure is due to a defect in BESA Items, the reasonable
costs and expenses of the investigation and recall shall be borne by BESA.  If the parties determine that the product
failure is due to a defect in XTENT’s Stents or Stent Systems, or is a result
of XTENT’s manufacturing or coating, XTENT shall bear the cost and expenses of
the investigation and recall.  If the
product failure is a result of a combination of contributing factors or the
actual cause cannot be determined, the costs and expenses of the investigation
and recall shall be borne by the Parties in the same proportion as XTENT’s net profit from sales of
Royalty Bearing Products (gross profits, less applicable royalties,
administrative and marketing costs) bears to actual royalties received by BESA.
If XTENT requests BESA to assist XTENT with the investigation or correction
procedure, BESA shall do so and all costs thereof shall be borne by XTENT
unless otherwise provided herein.


 


ARTICLE IX


 


INDEMNIFICATION


 


                9.1    General Indemnification by BESA.  Subject to the provisions of this Article IX,
BESA will defend, indemnify and hold harmless XTENT’s Indemnified Persons from
and against all Losses directly or indirectly incurred by any of them resulting
from or arising out of any of the following:


 


                        (a)      any breach of any of the representations
or warranties made by BESA contained in this Restated Agreement;


 


                        (b)      any breach of any of the covenants or
agreements made by BESA in this Restated Agreement; and


 


                        (c)      any breach of any duties or obligations
respecting the use and/or disclosure of XTENT’s (or its Affiliates’)
Confidential Information by BESA and/or its Affiliates.


 


30

















 


                BESA’s
liability to XTENT’s Indemnified Persons hereunder shall not exceed, in the
aggregate, that amount paid to BESA by XTENT pursuant to the terms of this
Restated Agreement, unless and solely to the extent such Losses arise from the
gross negligence or willful misconduct of BESA.


 


                9.2    General Indemnification by XTENT.  Subject to the provisions of this Article IX,
XTENT will defend, indemnify and hold harmless BESA’s Indemnified Persons from
and against all Losses directly or indirectly incurred by or sought to be
imposed upon any of them resulting from or arising out of any of the following:


 


                        (a)   any breach of any of the representations or
warranties made by XTENT in this Restated Agreement;


 


                        (b)   any breach of any of the covenants or
agreements made by XTENT in this Restated Agreement;


 


                        (c)   the research, development, use, sale or
commercialization by XTENT or any of its Sublicensees of any Royalty Bearing
Products, or any other product utilizing any of the Licensed Assets, except for
any liability or obligation arising from BESA’s work in connection therewith;


 


                        (d)   any liability or obligation arising from or
in connection with the tests, trials, and/or submissions conducted or performed
by XTENT or its Sublicensees, except for any liability or obligation arising
from BESA’s work in connection therewith; and


 


                        (e)   any breach of any duties or obligations
respecting the use and/or disclosure of BESA’s (or its Affiliates’)
Confidential Information by XTENT and/or its Sublicensees.


 


XTENT’s liability to BESA’s Indemnified Persons hereunder
shall not exceed, in the aggregate, that amount paid to BESA by XTENT pursuant
to the terms of this Restated Agreement, unless and solely to the extent such
Losses arise from the gross negligence or willful misconduct of XTENT.


 


                9.3    Limitation on General Indemnification.  Neither BESA nor XTENT will have any
indemnification liability under this Article unless one or more of the Indemnified
Persons gives written notice to the applicable Indemnifying Person asserting a
claim for indemnification in accordance with the procedures set forth in Section 9.4
of this Restated Agreement.


 


                9.4     Notice and Procedures.


 


                        (a)   An Indemnified Person will give prompt
written notice to the Indemnifying Person of each claim for indemnification
hereunder, specifying the amount and nature of the claim, and of any matter
which in the opinion of the Indemnifying Person is likely to give rise to an indemnification
claim.  The omission to give such notice
to an Indemnifying Person will not relieve the Indemnifying Person of any
liability under this Article except to the extent it was prejudiced
thereby.  As soon as practicable 


 


31

















 


after the date of such notice, the Indemnified Person will
provide the Indemnifying Person all information and documentation necessary to
support and verify the Losses so claimed and the Indemnifying Person and its
representatives will be given access to all books and records in the possession
or control of the Indemnified Person which the Indemnifying Person reasonably
determines to be related to such claim. 
The Indemnifying Person will have the right to defend the Indemnified Person
against such claim for Losses with counsel of its choice.


 


                        (b)   So long as the Indemnifying Person is
conducting the defense of the claim for Losses in accordance with this Section 9.4,
(i) the Indemnified Person may retain separate co-counsel, at its sole
cost and expense, and participate in the defense of the claim, (ii) the
Indemnified Person will not consent to the entry of any judgment or enter into
any settlement with respect to the claim without the prior written consent of
the Indemnifying Person, which consent will not be unreasonably withheld or
delayed, (iii) the Indemnified Person will reasonably cooperate with the
Indemnifying Person’s defense of such claim, and (iv) the Indemnifying
Person will not consent to the entry of any judgment or enter into any
settlement with respect to the claim without the prior written consent of the
Indemnified Person, which consent will not be unreasonably withheld or delayed;
provided, however, that such consent of the Indemnified Person will not be
required if the judgment or settlement contains a full release of claims
against the Indemnified Person. 
Notwithstanding any other provision of this Section 9.4, if an
Indemnified Person withholds its consent to a bona fide settlement offer, where
but for such action the Indemnifying Person could have settled such claim, the
Indemnifying Person will be required to indemnify the Indemnified Person only
up to a maximum of the bona fide settlement offer for which the Indemnifying
Person could have settled such claim.


 


                9.5    Payment of Indemnification.  Claims of indemnification under this Article will
be paid or otherwise satisfied by the Indemnifying Person within thirty (30)
days after notice thereof is given by the Indemnified Person and after the
parties agree on the allocation of responsibility for the items underlying
those claims of indemnification.  Unless
the Party receiving a claim of indemnification objects within fifteen (15) days
to the amount or allocation, it will be deemed to have agreed on the allocation
represented by the claim of indemnification. 
Payments made after the due date will bear interest at an annual rate
equal to the prime rate as published in the Wall Street Journal as of the 30th
day following such notice plus five percent (5%), or the maximum allowed by
law, if less, but not to exceed twelve percent (12%), in each case on that
portion of the claim that represents actual out of pocket expenses paid by the
Indemnified Person (if any).


 


32

















 


ARTICLE X


 


CONFIDENTIALITY


 


                10.1    Confidentiality.


 


                           (a)   “Confidential Information” means,
except as provided below, confidential and proprietary information of a Party
and its Affiliates, whether in written, printed, verbal or electronic form, and
whether disclosed before or after the Original Effective Date, including
research and development activities, product design details and specifications,
molecular structures, technology and know-how, sales and marketing plans,
finances and business forecasts, procurement requirements and vendor
information, customer lists, personnel information and strategic plans.
Confidential Information will not include information that: (i) is now, or
hereafter becomes generally known or available to the public through no act or
failure to act on the part of the receiving Party; (ii) was acquired by
the receiving Party before receiving such information from the disclosing Party
through no breach of any duty of confidentiality owed to the disclosing Party
and without restriction as to use or disclosure; (iii) is hereafter
rightfully furnished to the receiving Party by a third party without any breach
of any duty of confidentiality owed to the disclosing Party and without
restriction as to use or disclosure; or (iv) is information that the
receiving Party can document was independently developed by the receiving Party
without use of the disclosing Party’s Confidential Information.


 


                           (b)   Each Party, when it is the receiving Party
agrees: (i) to hold the disclosing Party’s Confidential Information in
strict confidence and not to disclose such Confidential Information to any
other person or entity without the prior written consent of the disclosing
Party; (ii) not to use, at any time following the execution of the
Original Agreement, any Confidential Information of the disclosing Party for
its own benefit or for the benefit of any other person or entity for any
purpose other than for the express purposes permitted under the Original
Agreement and this Restated Agreement; and (iii) to limit the disclosure
of Confidential Information to Permitted Persons.  For purposes hereof, the term “Permitted
Person” shall mean the receiving officers, directors, employees and agents who
have a need to know in order to carry out the obligations under this Restated
Agreement, provided each has agreed in writing to maintain the confidentiality
of the Confidential Information in a manner no less protective than that set
forth herein and   “Permitted Persons”
shall be deemed to include the Affiliates of BESA. Each Party shall be
responsible for ensuring compliance with the provisions contained in this Section 10.1
by their respective officers, directors, employees and agents.


 


                           (c)   The restrictions contained in this Section 10.1
will not apply to any disclosures by BESA to prospective investors, acquirers
or other financing sources in private business discussions.  BESA will be permitted to disclose the
existence or terms of this Restated Agreement with any prospective investor,
acquirer or other financing source, so long as such third party has agreed in
writing to be bound by confidentiality provisions substantially similar to
those contained in this Section 10.1. 
Notwithstanding the foregoing, BESA shall not disclose, without the
prior written consent of XTENT, any Confidential Information related to XTENT’s
Stent or the XTENT Stent System.


 


                           (d)   In the event a receiving Party is required to
disclose Confidential Information of the disclosing Party by any applicable
law, regulation, legal process, judicial order or by any applicable order or
requirement of any governmental or regulatory authority, it may do so only to
the extent required thereby; provided, however,


 


33














 


that the receiving Party will (i) use reasonable
efforts under the circumstances to provide advance notice to the disclosing
Party of the required disclosure to allow the disclosing Party an opportunity
to take steps to object to, prevent or limit its disclosure or obtain a
protective or other similar order with respect to the required disclosure and (ii) restrict
disclosure to only that portion of the Confidential Information that is
required to be disclosed.


 


(e)   The
receiving Party agrees that its obligations hereunder are necessary and
reasonable to protect the disclosing Party’s business interests and that the
unauthorized disclosure or use of the disclosing Party’s Confidential
Information may cause irreparable harm and significant injury, the degree of
which may be difficult to ascertain.  The
receiving Party further acknowledges and agrees that in the event of any actual
or threatened breach of this Restated Agreement, the disclosing Party may seek
an injunction enjoining any breach or threatened breach of this Restated
Agreement, as well as the right to pursue any and all other rights and remedies
available at law or in equity for such breach or threatened breach.


 


Upon the request of the disclosing Party and/or termination
of this Restated Agreement, the receiving Party will promptly return to the
disclosing Party or destroy all material embodying Confidential Information in
its possession or under its control, including all copies thereof, provided
however, the receiving Party shall be entitled to retain any such material that
it is required to maintain pursuant to applicable law or regulation.


 


 


ARTICLE XI


 


TERM AND TERMINATION OF AGREEMENT


 


                11.1    Term of Restated Agreement.  The term shall be deemed to have commenced
upon the Original Effective Date and shall continue in force for a period of
eight (8) years from the first date on which approval of the coated XTENT
Stents is received from a regulatory body, unless earlier terminated pursuant
to the provisions hereof.  Either Party
may cause this Restated Agreement to terminate upon the expiration of the
initial eight-year term by providing at least three (3) years advance
written notice to the other Party. 
Unless otherwise terminated, after the initial eight-year term, this
Restated Agreement shall automatically extend for up to one (1) additional
three-year term.


 


                11.2    Termination of Exclusivity Obligations.   XTENT’s exclusivity obligations under Section 2.3(b) will
terminate (i) as set forth in Section 5.3; or (ii) if XTENT is
subject to a Change of Control (as defined in Section 12.6).


 


                11.3    Termination for Cause.


 


                           (a)    By XTENT.  This Restated Agreement may be terminated by
XTENT if at any time following the Effective Date: (i) XTENT determines
that there existed a breach of any representation or warranty by BESA contained
in this Restated 


 


34

















 


Agreement in any material respect at the Effective Date and
BESA fails to cure such breach within sixty (60) days after receiving written notice
thereof from XTENT; or (ii) BESA fails to perform any post-execution
obligation or covenant contained in this Restated Agreement, provided, however,
that if such failure is capable of being cured, then such termination right
will not exist unless such failure has not been cured within sixty (60) days of
XTENT’s delivery to BESA of written notice of such failure or (iii) pursuant
to the provisions of Section 5.3.


 


                           (b)    By BESA.  In addition to the termination provisions
contained elsewhere in this Restated Agreement, this Restated Agreement may be
terminated by BESA if at any time following the Effective Date of this Restated
Agreement: (i) BESA determines that there existed a breach of any
representation or warranty by XTENT contained in this Restated Agreement in any
material respect at the Effective Date and XTENT fails to cure such breach
within sixty (60) days after receiving written notice thereof from BESA; (ii) XTENT
fails to perform any post-execution obligation or covenant contained in this Restated
Agreement, provided, however, that if such failure is capable of being cured,
then such termination right will not exist unless such failure has not been
cured within sixty (60) days of BESA’s delivery to XTENT of written notice of
such failure; (iii) pursuant to the provisions of Section 4.2(d), or (iv) XTENT
fails to obtain CE Mark approval for a Royalty Bearing Product by that date
which is the one year anniversary of the later of (i) the Effective Date
of this Restated Agreement; or (ii) the date the regulatory packages
pertaining to bulk Biolimus A9, bulk BESA’s Polymer Coating, and/or bulk BESA’s
Drug/Polymer Composite Formulation submitted by BESA or its Affiliates to XTENT’s
notified body or to the MEB for XTENT have been approved,  as indicated in a writing issued to either
BESA, XTENT or XTENT’s notified body by the MEB.


 


                           (c) 
  By Either Party for Insolvency.
In addition to the above rights to terminate, either Party may terminate on ten
(10) days’ written notice to the other if that other Party makes an
assignment for the benefit of creditors, files a petition in bankruptcy, is
adjudicated insolvent or bankrupt, or if a receiver or trustee is appointed
with respect to a substantial part of its assets or a similar proceeding is
commenced against that Party that would substantially impair its ability to
perform hereunder.


 


                11.4    Effect of Termination.  Each Party’s right of termination under this Article is
in addition to any other rights it may have under this Restated Agreement or
otherwise, and the exercise of a right of termination will not be an election
of remedies.  If this Restated Agreement
is terminated pursuant to this Article, all further rights and obligations of
the Parties under this Restated Agreement will terminate, including, without
limitation, the license granted hereunder, except that the rights and
obligations set forth in Sections 3.2(c), 4.2 (excluding 4.2(d)), 4.3, 5.5,
5.7, and 11.4, and ARTICLE VI, ARTICLE VII, ARTICLE VIII, ARTICLE IX, ARTICLE
X, and ARTICLE XII, and each of their subparts, will survive in accordance with
their respective terms; provided, however, that if this Restated Agreement is
terminated by a Party because of the breach of this Restated Agreement by
another Party or because one or more of the conditions to the terminating Party’s
obligations under this Restated Agreement is not satisfied as a result of
another Party’s failure to comply with its obligations under this Restated 


 


35

















 


Agreement, the terminating Party’s right to pursue all
remedies will survive such termination unimpaired.  Notwithstanding the foregoing, in the event
of a termination, XTENT shall continue to have the rights granted herein to the
extent necessary to sell any remaining inventory and to complete and sell any
work-in-process, subject to the payment of percentage royalties as set forth in
Section 4.2 and all payments due to BESA shall be made by XTENT.


 


ARTICLE XII




MISCELLANEOUS


 


                12.1    Fees and Expenses.  Except as provided below, each of the Parties
will bear its own legal, accounting and all other expenses in connection with
the negotiation and the consummation of the transactions contemplated by this
Restated Agreement.


 


                12.2    Notices.  Any notice or other communication in
connection with this Restated Agreement must be in writing, must be addressed
as provided below and will be deemed delivered when (a) actually delivered
electronically (including in the form of facsimile transmission with receipt
confirmed) or in person, provided that delivery is made during normal business
hours, (b) three business days have elapsed after deposit in the United
States mail, postage prepaid and registered or certified, return receipt
requested, or (c) two business days after sent by nationally recognized
overnight receipted courier:


 


	
   

  	
  if to BESA, to:

  
	
   

  	
   

  
	
   

  	
  Biosensors Europe S.A.

  
	
   

  	
  Rue de
  Lausanne 29,

  
	
   

  	
  1110 Morges
  (VD)

  
	
   

  	
  Switzerland

  
	
   

  	
  Telephone: +41 (0) 21 804 8000

  
	
   

  	
  Facsimile: +41 (0) 21 804 8001

  
	
   

  	
  Attention: Managing Director

  
	
   

  	
   

  
	
   

  	
  If to BIG, to

  
	
   

  	
   

  
	
   

  	
  Karen G. Krasney, Esq.

  
	
   

  	
  General Counsel

  
	
   

  	
  Biosensors International

  
	
   

  	
  20280 Acacia Street, Ste. 300

  
	
   

  	
  Newport Beach, CA 92660

  
	
   

  	
  Telephone: (949) 553-8300 Ext. 254

  
	
   

  	
  Facsimile: (949) 553-9129

  



 


36

















 


	
   

  	
   

  with a copy to 
  (which will not constitute notice to either BESA or BIG) to:

  
	
   

  	
   

  
	
   

  	
  Paul, Hastings, Janofsky & Walker LLP

  
	
   

  	
  515 South Flower Street, 25th Floor

  
	
   

  	
  Los Angeles, CA 90071-2371

  
	
   

  	
  Telephone: (213) 683-6000

  
	
   

  	
  Facsimile: (213) 627-0705

  
	
   

  	
  Attention:
  Rob R. Carlson, Esq.

  
	
   

  	
   

  
	
   

  	
  if to XTENT, to:

  
	
   

  	
   

  
	
   

  	
  XTENT, Inc.

  
	
   

  	
  125 Constitution Drive

  
	
   

  	
  Menlo Park, CA 94025

  
	
   

  	
  Telephone: (650) 475-9400

  
	
   

  	
  Facsimile: (650) 475-9401

  
	
   

  	
  Attention: Greg Casciaro, Chief Executive Officer

  
	
   

  	
   

  
	
   

  	
  with a copy (which will not constitute notice to
  XTENT) to:

  
	
   

  	
   

  
	
   

  	
  Jeff Grainger, Esq.

  
	
   

  	
  125 Constitution Drive

  
	
   

  	
  Menlo Park, CA 94025

  
	
   

  	
  Telephone: (650) 475-9400

  
	
   

  	
  Facsimile: (650) 475-9401

  



 


and in any case at such
other address as a Party may specify by written notice.  All periods of notice will be measured from
the date of deemed delivery as provided in this Section.


 


                12.3    Publicity and Disclosure of Restated
Agreement.  No press releases or any
public disclosure, either written or oral, of the transactions contemplated by
this Restated Agreement may be made that discloses information about this
Restated Agreement without the mutual consent of the Parties, except to
announce the execution of this Restated Agreement or to the extent required by
applicable law, rule or regulation (including stock exchange
requirement).  Either Party may disclose
the existence of this Restated Agreement, but may not disclose the terms
without the other Party’s written consent, except  (i) as required by law or by a court or
other governmental body; (ii) in confidence to legal counsel, accountants,
or banks; (iii) in confidence and using sound discretion, to actual and
potential financing sources and their advisors; (iv) in confidence, in
connection with the enforcement of this Restated Agreement or rights under this
Restated Agreement; (v) in confidence, in connection with a merger,
acquisition of stock or assets, proposed merger or acquisition, or the like; or
(vi) as advisable or required in connection with any government or
regulatory filings, including, without limitation, filings with the SEC or SGX
and in connection with an initial public offering; provided that to the extent
such a release of information is required by applicable law, rule or
regulation (including stock exchange requirement), the disclosing Party will
use commercially reasonable efforts to ensure that the content is accurate and
in accordance 


 


37

















 


with reasonable business standards and will, to the extent
practicable, provide the other Party with advance notice of the proposed
disclosure and an opportunity to review and comment upon such disclosure.  Notwithstanding the foregoing, nothing
contained herein shall be construed to permit any disclosure by XTENT of BESA’s
Confidential Information related to BESA’s Drug/Polymer Composite Formulation,
Biolimus A9 or BESA’s Polymer Coating following the execution of this Restated
Agreement, which is hereby prohibited under all circumstances without the prior
written approval of BESA.


 


                12.4    Entire Agreement.  This Restated Agreement (including all
exhibits) and all documents delivered pursuant to or referred to in this
Restated Agreement constitute the entire agreement between the Parties with
respect to the subject matter hereof and thereof, and all promises,
representations, understandings, warranties, agreements and inducements to the
making of this Restated Agreement relied upon by any Party have been expressed
in this Restated Agreement or in such documents. Unless otherwise stated herein,
this Restated Agreement (including all exhibits) supercedes and replaces all
prior agreements, written or oral, between the Parties with respect to the
subject matter hereof, including the Term Sheet dated August 22, 2003
executed by the Parties and the Original Agreement.


 


                12.5   Severability.  The invalidity or unenforceability of any
provision of this Restated Agreement will not affect the validity or
enforceability of any other provision of this Restated Agreement, and such
invalidity or unenforceability in any specific situation will not affect the
validity or enforceability of such provision in other situations.  Additionally, to the extent any provision of
this Restated Agreement is invalid or unenforceable, it will be interpreted and
applied as close to its original meaning as is permissible.


 


                12.6    Assignability.  Except in connection with a Change of
Control, which is subject to Section 12.6(a)-(d), neither this Restated
Agreement, nor any right or obligation hereunder, may be assigned by XTENT
without the prior written consent of BESA. 
In addition, except in connection with a Change of Control, any
attempted transfer by XTENT of the technology related to the BESA Items shall
be subject to the prior written approval of BESA. Unless otherwise expressly
consented to by BESA, no assignment by XTENT will relieve XTENT of any
obligations under any agreement, document or instrument executed and delivered
pursuant to this Restated Agreement.  Any
purported assignment in violation of this Restated Agreement will be null and
void and shall give BESA the option to immediately terminate this Restated
Agreement.  BESA shall have the right to
assign this Restated Agreement in its discretion. Subject to the foregoing,
this Restated Agreement will inure to the benefit of and be binding upon the
Parties and their respective successors and permitted assigns.


 


(a)    In the
event BESA enters into an agreement for a Change of Control or grants another
entity an option or right to enter into an agreement for a Change of Control,
the acquiring or surviving entity shall be bound by the terms and conditions of
this Restated Agreement.


 


38

















 


(b)    In the
event XTENT enters into an agreement for a Change of Control or grants another
entity an option or right to enter into an agreement for a Change of Control,
XTENT may assign this Restated Agreement to the acquiring or surviving entity
which shall be bound by the terms hereof, subject to the following:


 


                (i)    If at the time of such Change of Control the
acquiring entity markets a Stent for coronary or peripheral applications
incorporating Rapamycin or an analog thereof, (1) the terms of this
Restated Agreement shall remain in effect (2) BESA shall supply to the
acquiring or surviving entity its requirements (subject to the limitations set
forth in Section 3.2 hereof) of BESA’s Drug/Polymer Composite Formulation,
Biolimus A9 and/or BESA’s Polymer Coating solely for the purpose of utilizing
such BESA Items with XTENT’s Stents and XTENT Stent Systems as defined in this
Agreement (whether in its own facility or through a third party in another
facility) within XTENT’s Licensed Field of Use; and (3) the license set
forth in Section 2.1(a)(ii) to perform or have performed the coating
shall remain in force but only for the limited purpose of allowing such entity
to incorporate BESA’s Drug/Polymer Composite Formulation, Biolimus A9 and/or
BESA’s Polymer Coating, with XTENT’s Stents and XTENT Stent Systems for XTENT’s
Licensed Field of Use.  All licenses
under ARTICLE II shall remain in force to allow such acquiring entity to
import, export, use, test, sell, and offer for sale XTENT’s Stents and XTENT
Stent Systems incorporating the BESA Items within XTENT’s Licensed Field of
Use, subject to the terms of this Restated Agreement. For purposes of clarity,
under no circumstances shall any acquiring or surviving entity utilize any of
the BESA Items subject to the licenses hereunder for any purpose or use other
than in connection with XTENT’s Stents within XTENT’s Licensed Field of Use.


 


                (ii)   In advance of any Change of Control, XTENT
shall limit disclosure of BESA’s Confidential Information to only that
information necessary for obtaining and maintaining regulatory approvals for
(as set forth in ARTICLE V)  XTENT Stents
and XTENT Stent Systems .  In the event
that after a Change of Control, either XTENT or the acquiring or surviving
entity desires to use, for purposes other than obtaining and maintaining
regulatory approvals, any Confidential Information of BESA or its Affiliates,
including, without limitation, BESA’s coating technology, testing methodologies
and other Know-How for coating, testing, manufacturing, marketing or
selling XTENT’s Stents or XTENT Stent Systems
incorporating any of the BESA Items, XTENT or the acquiring or surviving entity
shall pay BESA the sum of [****]Dollars (US$[****]) for the right to use such
Confidential Information. If XTENT reasonably believes that a change of control
may occur, XTENT shall promptly notify BESA and XTENT shall promptly return to
BESA all of BESA’s Confidential Information as may be requested in writing by
BESA, except that which is necessary for the foregoing.


 










CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


39

















 


(c)  In the event XTENT enters into an agreement for a
Change of Control, or grants another entity an option or right to enter into an
agreement for a Change of Control, XTENT or the surviving entityshall have the
right, but not the obligation, to either (i) terminate this Restated
Agreement and all rights hereunder upon thirty (30) days written notice to
XTENT; or (ii) terminate the exclusivity obligations under Section 2.3(b).


 


(d)   For  purposes of this Restated Agreement, “Change
of Control” means a transaction or a series of related transactions in
which (i) one or more related parties who did not previously own at least
a fifty percent (50%) interest in a Party to this Restated Agreement obtain at
least a fifty percent (50%) interest in such Party, or (ii) a third party
acquires all or substantially all of the assets to which this Restated
Agreement relates, or (iii) a Party acquires, by merger, acquisition of
assets or otherwise, all or any portion of another legal entity such that
either the assets or market value of such Party after the close of such transaction
are greater than one hundred thirty-three percent (133%) of the assets or
market value of such Party prior to such transaction.  The effective date of such a Change of
Control shall be the date of the first transaction in which any of the
foregoing events occurs or in which a Party or third party acquires an option
or right to cause any of the foregoing events to occur.


 


                12.7    Amendment.  This Restated Agreement may be amended only
by a written agreement executed by XTENT and BESA.


 


                12.8    Governing Law.  This Restated Agreement shall be governed by,
and construed in accordance with, the laws of the State of California and the
United States, as though made and to be fully performed therein without regard
to conflicts of laws principles thereof.  The Parties agree that any legal or equitable
action arising out of any dispute under this Restated Agreement shall only be
commenced in any federal or state court located in the State of California
having subject matter jurisdiction over such action and that any such court
shall have jurisdiction over the Parties and venue of the action shall be
appropriate in such court.  The Party
prevailing in any such action shall be entitled to recover its reasonable
attorneys’ fees and costs incurred in connection with any such litigation.


 


                12.9    Counterparts.  This Restated Agreement may be executed in
multiple counterparts, each of which will be deemed an original but all of
which together will constitute one and the same instrument, and all signatures
need not appear on any one counterpart.


 


                12.10    Interpretation.  The Parties acknowledge and agree that: (a) each
Party and its counsel reviewed and negotiated the terms and provisions of this
Restated Agreement and have contributed to its revision; (b) the rule of
construction to the effect that any ambiguities are resolved against the
drafting Party will not be employed in the interpretation of this Restated
Agreement; and (c) the terms and provisions of this Restated Agreement
will be construed fairly as to all Parties and not in favor of or against any
Party, regardless of which Party was generally responsible for the preparation
of this 


 


40

















 


Restated Agreement. 
When used in this Restated Agreement, the words “including” or “includes”
are deemed to be followed by the words “without limitation.”


 


                12.11    Headings.  Any table of contents, title or Article or
Section heading is for convenience of reference only and will not affect
the meaning or construction of any of the provisions of this Restated
Agreement.


 


                12.12    Currency.  Unless otherwise specified in this Restated
Agreement, all references to currency, monetary values and dollars set forth
herein will mean United States dollars and all payments hereunder will be made
in United States dollars.


 


                12.13    Further Assurances.  BESA and XTENT, from time to time after the
execution of this Restated Agreement at the request of the other Party and
without further consideration, will execute and deliver further instruments of
transfer and assignment (in addition to those specifically contemplated in this
Restated Agreement) and take such other action as such other Party may
reasonably request to more effectively fulfill the intents and purposes of this
Restated Agreement.


 


                12.14    No Third Party Beneficiaries.  Nothing in this Restated Agreement expressed
or implied is intended to confer on any person other than the Parties and their
respective Affiliates, representatives, successors and permitted assigns, any rights,
remedies, obligations or liabilities under or by reason of this Restated
Agreement.


 


                12.15    Waiver.  No delay or omission on the part of either
Party in requiring performance by the other Party hereunder, or in exercising
any right hereunder, shall operate as a waiver of any provision hereof or of
any right or rights hereunder, and the waiver or omission or delay in requiring
performance or exercising any right hereunder on one occasion shall not be
construed as a bar to or waiver of such performance or right, or of any right
or remedy under this Restated Agreement, on any future occasion.


 


                12.16    Force Majeure.  Neither Party shall be liable for delay or
failure in the performance of any of its obligations under this Restated
Agreement if and to the extent such delay or failure is due to circumstances
beyond the reasonable control of such Party, including, but not limited to,
fires, floods, explosions, accidents, acts of God, war, riot, strike, lockout
or other concerted acts of workers, acts of government; provided, however, that
the Party claiming that a force majeure has affected its performance shall give
notice to the other Party within ten (10) days of becoming aware of the
occurrence of force majeure, giving full particulars of the cause or event and
the date of first occurrence thereof. 
The Party claiming force majeure shall use its best efforts to eliminate
or prevent the cause so as to continue performing its obligations under this
Restated Agreement as soon as possible.


 


                12.17    Independent Contractors.   BESA and XTENT are independent contractors
and nothing contained in this Restated Agreement shall be construed to
constitute either Party as a partner, joint venturer, co-owner, or employee of
the other Party, and neither Party shall hold itself out as such.  Neither Party has any right or authority to
incur, assume or create, in writing or otherwise, any warranty, liability or 


 


41

















 


other obligation of any kind, express or implied, in the
name of or on behalf of the other Party.


 


                12.18   Guaranty.  BIG hereby irrevocably and unconditionally
guarantees to XTENT the full, complete and prompt performance and observance of
all of BESA’s duties and obligations under this Restated Agreement, and under
all other agreements between BESA and XTENT related to this Restated Agreement
or the subject matter thereof, as and when such duties and obligations may be
or become due to XTENT from BESA, including, without limitation, delivery and
manufacturing obligations, indemnity obligations, and payment of all damages,
liability, costs, expenses and other amounts that may be payable to XTENT, or
recoverable by XTENT, from BESA as a result of this Restated Agreement.  In the event that BESA sublicenses, assigns,
contracts, or otherwise transfers any of its obligations under this Restated
Agreement to an Affiliate or other entity under the ownership or control of
BIG, BIG further unconditionally guarantees the performance of such obligations
by such Affiliate and payment of all damages, liability, costs, expenses and
other amounts that may be payable to XTENT, or recoverable by XTENT, from such
Affiliate or entity as a result of this Restated Agreement.  The foregoing is a continuing, irrevocable
guaranty that remains in full force and effect for all such duties and
obligations, and claims based thereon, whenever arising, until the expiration
of such duties and obligations.


 


                12.19   Mutual Release of All Claims.


 


(a)  
By entering into this Restated Agreement, each Party hereby completely
and fully releases and discharges the other Party from any and all claims,
promises, causes of action, or similar rights of any type arising under or with
respect to the Original Agreement and such other Party’s obligations thereunder,
but only to the extent such claims, promises, causes of action, or similar
rights arise out of facts or circumstances which the releasing Party knows
or reasonably should know as of the Effective Date of this Restated Agreement
(the “Released Claims”); provided, however, that the Released Claims shall not
include any and all claims, cause of actions, or other rights arising out of or
related to (i) a claim, investigation, or cause of action brought by any
third party or government agency against a Party including, but not limited to,
product liability claims; (ii)  intentional misrepresentation or deception
by a Party which is not known to the releasing Party as of the Effective Date
of this Restated Agreement; or (iii) facts, circumstances, or actions
occurring or otherwise arising after the Effective Date of this Restated
Agreement.  Each Party agrees (on behalf of itself, its affiliates and
their officers, directors, agents, representatives, consultants and
representatives) not to initiate any claim against the other Party for any
losses or other harm (known or unknown) sustained or incurred by the releasing
Party as a result of the Released Claims.


 


(b)  
The parties agree that this Restated Agreement contains a general
release with respect to the matters to be released hereunder and XTENT and BESA
each expressly waives the provisions of California Civil Code Section 1542,
which provides:


 


“A general release does not extend to claims which the creditor does
not know or suspect to exist in his favor at the time of executing the release,



 


42

















 


which if known by him must have materially affected his settlement with
the debtor.”


 


(c)   Each
Party agrees not to assert that this Restated Agreement or the release
contained herein is an admission of wrongdoing or liability on the part of the
other Party.


 


(d)   Each Party agrees to
remain bound by the terms of this Restated Agreement.


 


Signature Page Follows


 


43

















 


IN WITNESS WHEREOF, the Parties
have caused this Restated Agreement to be executed by their duly authorized
representatives as of the date set forth above.


 


	
   

  	
  XTENT, INC.

  	
   

  



 


	
   

  	
  By:

  	
  /s/ Greg Casciaro

  	
   

  
	
   

  	
   

  	
  Greg Casciaro

  	
   

  
	
   

  	
  Its:

  	
  Chief Executive Officer

  	
   

  



 


	
   

  	
  BIOSENSORS EUROPE S.A.

  	
   

  



 


	
   

  	
  By:

  	
  /s/ Jeffrey Jump

  	
   

  
	
   

  	
   

  	
  Jeffrey Jump

  	
   

  
	
   

  	
  Its:

  	
  Managing Director

  	
   

  



 


	
   

  	
  BIOSENSORS INTERNATIONAL GROUP, LTD.

  	
   

  



 


	
   

  	
  By:

  	
  /s/ Yoh-Chie Lu

  	
   

  
	
   

  	
   

  	
  Yoh-Chie Lu

  	
   

  
	
   

  	
  Its:

  	
  Chief Executive Officer

  	
   

  



 


44

















 


EXHIBIT A


 


[****]


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


45

















 


EXHIBIT 1.2


 


[****]


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


46

















 


EXHIBIT 1.17


 


[****]


 






CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


 


47