exv10w15



 





[NOTE:
CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL INFORMATION HAS BEEN OMITTED. CONFIDENTIALITY HAS BEEN
REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE CONFIDENTIAL
PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECURITIES AND EXCHANGE
COMMISSION]




Exhibit 10.15




LICENSE AGREEMENT



THIS LICENSE AGREEMENT (the “Agreement”) is made and entered into as of this
30th day of April, 2002 (the “Effective Date”) by and between Volcano
Therapeutics, Inc. (“VOLCANO”), a corporation organized and existing under the
laws of the State of Delaware and having an office at 26061 Merit Circle, Suite
103, Laguna Hills, CA 92635 and The Cleveland Clinic Foundation (“CCF”), a
non-profit corporation established under the laws of the State of Ohio and
located at 9500 Euclid Avenue, Cleveland, OH 44195.



WHEREAS, VOLCANO is involved in developing medical devices for the
detection and treatment of atherosclerotic disease, in particular
vulnerable plaque;



WHEREAS, researchers at CCF have developed certain methods, algorithms, software,
devices and related know-how (the “CCF-IP”) that are complementary to and can
enhance the VOLCANO devices, and whereas CCF has taken steps to protect CCF-IP
including obtaining patent protection for the patentable portions of the CCF IP;
and



WHEREAS, VOLCANO is desirous of licensing, developing and marketing the
CCF-IP and CCF is desirous of granting VOLCANO a license to the CCF-IP.



NOW, THEREFORE, in consideration of the mutual covenants, agreements and
conditions set forth herein, CCF and VOLCANO agree as follows:




Section 1 — DEFINITIONS




These terms shall have the following meanings when used herein:



1. “Deliverables” shall mean, in addition to the Licensed Patents and Licensed
Technology, it is contemplated by the parties that CCF shall provide as an
important part of the consideration for this Agreement certain Deliverables upon
which performance by VOLCANO depends; these Deliverables include transfer of a
prototype product including a look-up table for implementing certain algorithms
and continuing participation of CCF in product development and testing and after
product launch to ensure continued Improvements of the products.



2. “Enabled Products” shall mean only those products that are not themselves
Licensed Products but which are specifically designed to operate in conjunction
with Licensed Products so as to enable other products to operate with the
Licensed Products, such as an adapter that allows the use of a commercial IVUS
(intravascular ultrasound) catheter with an instrument that is a Licensed
Product.



3. “Field” shall mean the diagnosis and treatment of atherosclerosis and related
vascular diseases using intravascular methods.



4. “Improvements” shall mean future improvements to the Licensed Patents and/or
the Licensed Technology, in particular improvements that are developed by the
inventors named in the CCF cases listed in Exhibit A or by persons who are or
have been members of the laboratories of those inventors.




Page 1 of 16









 




5. “Licensed Patents” shall mean the patents and patent applications listed on Exhibit A hereto,
and all provisional applications, divisional applications, substitution applications, continuation
applications, continuation-in part applications, and reissue applications, re- examination
applications, and extensions of or derivatives of the preceding, patents issuing on each of the
preceding, and all foreign counterparts based on, containing the substance of or derived from each
of the preceding.



6. “Licensed Products” shall mean all products or services covered by a valid issued claim of a
Licensed Patent or a claim of a pending patent application in the country in which such Licensed
Product is sold or manufactured and/or incorporate of otherwise utilize Licensed Technology.



7. “Licensed Technology” shall mean all proprietary information, know-how, procedures, methods,
prototypes, designs, technical data, reports, software, algorithms, trade secrets, improvements and
data owned by CCF or in which CCF has any rights that are related to or derived from CCF IP
including Improvements thereon made during the term of this Agreement, and that are necessary or
useful in the development, manufacture or use of Licensed Products.



8. “Net Sales” shall mean the total amount received from the sales of a Licensed Product less
product returned for credit or used for demonstration or marketing purposes. Licensed Product
donated by VOLCANO to a bona fide charity or non-profit research entity is not included in Net
Sales provided VOLCANO receives no revenue from such donations.



9. “Territory” shall mean worldwide.



10. “Unit” shall mean a Licensed Product that consists of (i) a combination of the Licensed Patents
and/or the Licensed Technology with VOLCANO technology or (ii) the Licensed Patents and/or the
Licensed Technology without VOLCANO technology (i.e., a stand-alone product), as the case may be,
and that generates a gross revenue amount upon sale of such Unit.




Section 2 — GRANT



CCF hereby grants and VOLCANO hereby accepts an exclusive irrevocable license (subject to the terms
and conditions herein) in the Field and Territory to the Licensed Patents and Licensed Technology
to make, have made, use, import, have imported, develop, have developed, improve, have improved,
offer for sale, sell and have sold Licensed Products in the Territory. This license includes the
right to grant and authorize sublicenses, under the Licensed Patents and Licensed Technology.




Section 3 — LICENSE FEE



1. A payment of two hundred thousand dollars ($200,000) will be made to CCF upon execution
of this License Agreement and delivery of the Licensed Patents, Licensed Technology and the
existing prototype product including data, documentation, algorithms, look up tables and source
code software developed by CCF prior to the execution of this Agreement.




Page 2 of 16









 




2. A payment of one hundred and twenty-five thousand dollars ($125,000) will be made to CCF upon
European Community regulatory clearance or first commercial sale within the European Community,
whichever event occurs first.



3. A payment of one hundred and twenty-five thousand dollars ($125,000) will be made to CCF upon
United States FDA regulatory clearance or first commercial sale within the United States, whichever
event occurs first.




Section 4 — PARTICIPATION



1. Within sixty- (60) days of the execution of this Agreement the parties will mutually develop and
agree upon a plan and schedule (the “PD Plan”) whereby CCF shall diligently participate with
VOLCANO in the development and testing of Licensed Products leading to regulatory clearance and
product launch (commercial sale) for the Licensed Products. As part of the PD Plan, Contact
Personnel at CCF and at VOLCANO shall be identified. The PD Plan will then be attached to this
Agreement as Exhibit B and may be updated from time to time at the request of the parties.



2. CCF will make a written report to VOLCANO on a quarterly basis detailing its progress on the PD
Plan and presenting results and any Improvements to VOLCANO.



3. The Contact Personnel from CCF and VOLCANO will meet periodically, but no less frequently than
quarterly, to report and discuss their respective progress. These meetings may be held by video or
teleconference as the parties may decide; however, if VOLCANO requests that CCF Contact Personnel
travel outside of the Cleveland metropolitan area to meet, then VOLCANO shall reimburse the
reasonable travel expenses incurred by the CCF Contact Personnel pursuant to such meeting. At these
meetings, the PD Plan will be revised if necessary with the revisions being promulgated to the
parties.



4. According to the PD Plan, VOLCANO may submit instruments and/or software to CCF with requests
for testing and evaluation, with the costs and particulars for such testing and evaluation to be
mutually agreed upon by the parties in advance. VOLCANO will propose a target for the completion of
each such request. CCF shall make its best efforts to respond to these requests in a timely manner.
If CCF reasonably believes the proposed target is unattainable, it must make a counter proposal,
and the parties will mutually agree upon a target. Failure to respond to requests of this Section 4
in a timely manner by meeting the target shall toll the time limits of Section 9 for so long as the request remains unmet.



5. If, in the sole opinion of VOLCANO, CCF is not diligently participating in the PD plan, then the
following procedures will apply:




     (a) VOLCANO shall provide written notice to CCF in which it specifies the nature of CCF’s
perceived lack of diligent participation (hereafter “breach of participation”).



     (b) CCF shall have sixty- (60) days in which to respond to the written notice, such response
to delineate CCF’s position thereto, i.e., agreement or rebuttal.




Page 3 of 16










 







     (c) After
receipt of CCF’s response, the parties will schedule and then conduct a
meeting by video or teleconference to reach consensus as to what action or actions need to be taken
and/or whether the PD Plan should be modified to accommodate new circumstances.



     (d) If, despite best efforts, the parties fail to reach a consensus or if CCF fails to
fulfill its mutually-agreed-upon responsibilities as to a cure for a breach of participation within
one hundred and twenty- (120) days following the video or teleconference, then CCF shall refund
five percent (5%) of the License Fee paid to that date.



Section 5 — PRODUCT MEETINGS



Following product launch, Contact Personnel from VOLCANO and CCF shall continue to have Product
Meetings at least quarterly to report to each other problems or progress with existing Licensed
Products and development of new Licensed Products. These meetings may be held by video or
teleconference as the parties may decide; however, if VOLCANO requests that CCF Contact Personnel
travel outside of the Cleveland metropolitan area to meet, then VOLCANO shall reimburse the
reasonable travel expenses incurred by the CCF Contact Personnel pursuant to such meeting.




Section 6 — UPDATES



1. CCF shall have a continuing affirmative duty to work diligently to update the data,
documentation, algorithms, look up tables and source code software delivered in Section 3 as
changes and Improvements to the same are made by CCF.



2. Prior to commercial launch of the first Licensed Product, the Updates shall be made
through the PD Plan and meetings connected with the PD Plan.



3. Following commercial launch, the Updates shall be made through the Product Meetings or
sua sponte by CCF.



4. VOLCANO shall have a continued right to submit instruments and/or software to CCF with
requests for testing and evaluation. VOLCANO will submit such requests in writing to CCF and CCF
shall use reasonable efforts to respond to these requests in a timely manner. If CCF is willing and
able to perform such testing and evaluation, then the parties will mutually agree upon the costs
and particulars (including milestones) for such testing and evaluation in advance.



5. For technologies un-related to the Licensed Patents and/or the Licensed Technology,
VOLCANO shall have a right to submit instruments and/or software to CCF with requests for testing
and evaluation. Such testing and evaluation shall be conducted at the sole discretion of CCF, with
the costs and particulars for such testing and evaluation to be mutually agreed upon by the parties
in advance.





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Section 7— ROYALTIES



1. In countries where manufacture, sale or use of Licensed Products is covered by a
valid claim of an issued Licensed Patent and or incorporates or otherwise utilizes the Licensed
Technology, a royalty of [CONFIDENTIAL] of the Net Sales amount received by VOLCANO, or
its sublicensees, from the sale of each Unit of Licensed Product will
be paid to CCF.



2. In countries where manufacture, sale or use of Licensed Products is covered by a valid
claim of an issued Licensed Patent and/or incorporates or otherwise utilizes the Licensed
Technology, a royalty of [CONFIDENTIAL] of the Net Sales amount received by
VOLCANO, or its sublicensees, from the sale of each unit of an Enabled Product will be paid to CCF.



3. After the last Licensed Patent expires the royalty of Section 7.1 shall be reduced to
[CONFIDENTIAL] and the royalty of Section 7.2
shall be reduced to [CONFIDENTIAL].



4. If VOLCANO, in its sole discretion, determines that CCF is not diligently participating in the
Progress Meetings and/or is not diligently responding to requests to evaluate instruments and
software, then the following procedures will apply:




     (a) VOLCANO shall provide written notice to CCF in which it specifies the nature of
CCF’s perceived lack of diligent response (hereafter “breach of diligent response”).



     (b) CCF shall have sixty- (60) days in which to respond to the written notice, such
response to delineate CCF’s position thereto, i.e., agreement or rebuttal.



     (c) After receipt of CCF’s response, the parties will schedule and then conduct a
meeting by video or teleconference to reach consensus as to what action or actions need to be
taken.



     (d) If, despite best efforts, the parties fail to reach a consensus or if CCF fails to
fulfill its mutually-agreed-upon responsibilities as to a cure for a breach of diligent response
within one hundred and twenty days- (120) days following the video or teleconference, then VOLCANO
may, in its sole discretion, withhold payment of fifty percent (50%) of the Royalties then due and
owing to CCF until such time CCF cures such breach of diligent response to the satisfaction of
VOLCANO. Upon cure by CCF, VOLCANO would then immediately remit to CCF any Royalties being
withheld.




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Section 8 — PAYMENT



Payments arising hereunder will be made within sixty- (60) days of when the obligation accrues.
In the case of Royalty Payments the accrual date will be the close of each calendar quarter
(March 31, June 30, September 30 and December 31). Payment will be made in United States
currency by means of a cashier’s check delivered to the address listed below for CCF or by wire
transfer to an account specified by CCF. VOLCANO will maintain standard business records of
sufficient quality for the verification of all sales of Licensed Products and Enabled Products for
the past two (2) years. An auditor mutually acceptable to CCF and VOLCANO may audit these
records at VOLCANO’s regular place of business during regular business hours upon thirty- (30)
days written notice no more often than once per year. The auditor will verify all sales of
Licensed Products, but the auditor must be sworn to reveal only the amounts of the transactions
and not the identity or location of VOLCANO’s customers to CCF. If the auditor determines
that royalties paid to CCF were underpaid by five percent (5%) or more, VOLCANO will bear the cost
of the audit. Otherwise the cost of the audit shall be borne by CCF.




Section 9 — LICENSE EXCLUSIVITY



The exclusive license shall become a non-exclusive license, on a country-by-country basis,
according to the following:




     (i) VOLCANO will make all reasonable efforts to obtain regulatory approval for the
Licensed Products. VOLCANO will achieve regulatory approval in a particular country within
three (3) years of the execution of this License Agreement. If it appears that the deadline
will
not be met, the parties agree to confer and reach a consensus on action(s) to be taken
regarding
same. If the parties cannot reach a consensus, and if the deadline is not met, CCF may convert
the exclusive license to a non-exclusive license within the particular country.



     (ii) VOLCANO will start selling Licensed Products within one (1) year from the date
relevant regulatory approval is obtained in a particular country. If it appears that the
deadline
will not be met, the parties agree to confer and reach a consensus on action(s) to be taken
regarding same. If the parties cannot reach a consensus, and if the deadline is not met, CCF
may
convert the exclusive license to a non-exclusive license within the particular country.



Section 10 — PATENT PROSECUTION



VOLCANO will be responsible for and fund, using patent counsel of its choice, with CCF
having right of review and comment, the preparation, filing, prosecution and maintenance of the
Licensed Patents. CCF shall cooperate in patent prosecution and shall execute any document
reasonably necessary to ensure such patent prosecution. Should VOLCANO decide to abandon
or not pursue any of the Licensed Patents, CCF will be promptly informed and may take over the
preparation, filing, prosecution and maintenance at its sole discretion and expense. Further, in
the event of such abandonment, the use rights granted to VOLCANO pursuant to Section 2 that
pertain to such abandoned Licensed Patents shall be terminated.




Page 6 of 16









 








Section 11 — PATENT ENFORCEMENT



CCF shall promptly report any apparent infringement of the Licensed Patents or alleged
infringement of third party patents to VOLCANO in writing. VOLCANO shall have the right,
but not the duty, to pursue any infringement of the Licensed Patents, or defend any declaratory
judgment with respect thereto. CCF shall support these actions by supplying documents and
making their personnel reasonably available for testimony and other activities necessary to
support these actions. Any recovery obtained in such an action shall be used first to reimburse
VOLCANO for the costs of such an action. Any recovery remaining after such reimbursement
shall to split seventy-five percent/twenty-five percent (75%/25%) between VOLCANO and
CCF. If VOLCANO elects not to pursue any infringement or defend any declaratory judgment,
CCF may take over the action at its own expense in which case CCF shall retain any recovery
obtained therein.




Section 12 — THIRD PARTY ROYALTIES



In the
event that in connection with its manufacture, use or sale of Licensed Products,
VOLCANO pays a third party royalties or other amounts to avoid or settle a claim of
infringement of the intellectual property rights of such a third party, VOLCANO may offset such
amounts against up to [CONFIDENTIAL] of the royalty amounts due CCF. If
VOLCANO is not able to avoid or settle a claim of infringement of the intellectual property of a
third party and such continuing claim of infringement prevents VOLCANO from selling
Licensed Products, VOLCANO shall have the option of immediately terminating this Agreement
in regards to the country or territory where infringement prevents VOLCANO from selling
Licensed Products unless CCF resolves the claim of infringement at CCF’s expense.




Section 13 — REGULATORY APPROVALS



VOLCANO
shall be solely responsible for securing any federal, including U.S. Food and Drug
Administration (“FDA”), state, local or foreign regulatory approval necessary for commercial
sale of Licensed Products. Each regulatory approval shall be made in VOLCANO’S name unless
applicable law requires otherwise, or CCF and VOLCANO otherwise agree that a particular
approval be made in the name of CCF. CCF agrees that, notwithstanding any such regulatory
approval made in its name, VOLCANO retains the exclusive rights to make, have made, import,
export, use, distribute, promote, offer for sale and sell Licensed Products as granted to
VOLCANO in this Agreement. Pursuant to Section 4 above, CCF will lend assistance on a
reasonable basis to facilitate VOLCANO’s acquisition of necessary regulatory approvals for
commercial sale. Such assistance will include the provision to VOLCANO as promptly as
reasonably practicable of scientific and clinical data obtained by CCF relating to the Licensed
Patents, the Licensed Technology, and/or the Licensed Products. VOLCANO shall be
responsible for reimbursing CCF for any reasonable direct costs associated with such activity.





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Section 14 — TERMINATION



1. Unless earlier terminated by breach or election of VOLCANO, the license granted hereunder will
terminate on a country-by-country basis upon the expiration of the last to expire Licensed Patent
or the lapsing of the last patent application in such country. After such expiration or lapsing
VOLCANO shall have a paid-up, perpetual royalty-free license to the Licensed Patents in that
country. However, the Agreement shall continue for as long as Licensed Technology is incorporated
or otherwise utilized by VOLCANO in the manufacture, sale or use of the Licensed Products and/or
CCF continues to participate with Volcano in product development and evaluation as described above.



2. VOLCANO may elect to terminate fee license granted hereunder with respect to any Licensed Patent
or any country (without terminating the entire Agreement), on sixty- (60) days written notice.



3. The termination of this Agreement or any portion thereof as provided in Section 14.1 shall not
release either party from any obligation that matured prior to the effective date of said
termination.




Section 15—BREACH



If either party commits a material breach or defaults in the performance of a material provision of
this Agreement, and such breach or default is not cured within ninety- (90) days after the receipt
of written notice from the other party specifying the breach or default, the party not in breach or
default shall be entitled to terminate this Agreement without additional penalty or cost by giving
written notice to the other party, such notice being immediately effective.




Section 16 — REPRESENTATIONS AND WARRANTIES OF CCF TO VOLCANO



CCF represents and warrants that:




     (i) it has full right, power and authority to enter into this Agreement;



     (ii) with respect to the Licensed Patents and Licensed Technology, it has the right and
authority necessary to grant the exclusive license of Section 2;



     (iii) the Licensed Patents and Licensed Technology are free of any lien or
encumbrance or any rights or claims of any third party;



     (iv) the delivery and performance of this Agreement do not conflict, breach or violate any
other agreement to which it is a party;



     (v) the
Licensed Patents and Licensed Technology, i.e., the CCF IP, and the rights granted
to VOLCANO therein are adequate and sufficient for VOLCANO to exercise fully its exclusive
license as provided for herein and as contemplated by the parties;



     (vi) to
the best of its knowledge and belief, the Licensed Patents and Licensed
Technology do not infringe any valid patents or proprietary rights of third parties;



Page 8 of 16









 





     (vii) to the best of knowledge and belief, it is not aware of any third party
activities that would infringe or invalidate the Licensed Patents or Licensed Technology; and



     (viii) during
the term of this Agreement it shall not enter into any agreement that is
inconsistent with or in derogation of its warranties and representations just made herein.



Section 17 — REPRESENTATIONS AND WARRANTIES OF VOLCANO TO CCF 



VOLCANO represents and warrants that:




     (i) it is a corporation duly organized, validly existing, authorized to exercise all its
corporate powers, rights and privileges, and in good standing in the State of Delaware and that it
has full right, power and authority to enter into this Agreement and to accept the license of
Section 2;



     (ii) it has the expertise necessary to independently evaluate the Licensed Patents and the
Licensed Technology for sale in the commercial market and to develop Licensed Products for sale in
the commercial market and that it so intends to develop Licensed Products for the commercial
market;



     (iii) the delivery and performance of this Agreement do not conflict, breach or violate
any other agreement to which it is a party; and



     (iv) during the term of this Agreement it shall not enter into any agreement that is
inconsistent with or in derogation or its warranties and representations just made herein.



Section 18 — INDEMNIFICATION



1. VOLCANO shall indemnify, hold harmless, and defend CCF including its officers, employees and
agents against any and all claims for death, illness, personal injury, property damage and any
other damages incidental to or arising out of manufacture, use, sale, or other disposition of the
CCF IP.



2. CCF will promptly notify VOLCANO in writing of any lawsuit that it intends to include within the
indemnification of this Section 18.




Section 19
— LIMITATION OF LIABILITY



1. In no event shall the parties be liable to each other or to any other party for incidental,
special, consequential, or punitive damages, including, but not limited to lost revenue or profits,
in connection with this Agreement or its breach, or arising from the relationship of the parties or
the conduct of business between them.



2. VOLCANO’s liability to CCF for damages of any kind is limited to the aggregate amount
paid to CCF by VOLCANO under this Agreement.




Page 9 of 16









 








Section 20 — PUBLICITY



VOLCANO shall not identify CCF in any promotional advertising, publication, communication or other
materials disseminated to the public nor use the name of any CCF employee or agent or use any CCF
trademark or service mark without prior written approval from CCF. Similarly, CCF shall not
identify VOLCANO or any VOLCANO officer, agent or employee in any publication or communication or
use any VOLCANO trademark or service mark without prior written approval from VOLCANO.




Section 21 — DISPUTE RESOLUTION



1. The parties shall attempt in good faith to resolve any dispute arising out of or relating to
this Agreement promptly between officials who have authority to settle the controversy.



2. If the matter has not been resolved by negotiation within thirty- (30) days, the parties shall
attempt in good faith to settle the dispute by mediation under the then-current rules of the
American Arbitration Association (“AAA”). The neutral third party will be selected from the panel
of neutrals of the AAA in accordance with the selection process of the AAA.



3. If the matter has not been resolved by mediation within ninety-(90) days of the initiation of
such procedure, or if either party will not participate in a
mediation, then the dispute shall be
resolved under the Commercial Dispute Rules of the American Arbitration Association by a single
arbitrator, mutually acceptable to the parties. The prevailing party shall have the right to
enforce the award of the arbitrator in a court of competent jurisdiction. In any arbitration, the
prevailing party shall be entitled to arbitration fees and the arbitrator may ward reasonable
attorneys’ fees and any other fees, as the arbitrator shall designate.



4. Such mediation or arbitration shall be held in Los Angeles, California if invoked by CCF and in
Cleveland, Ohio if invoked by VOLCANO




Section 22 — SEVERABILITY



If any portion of this Agreement is held void or unenforceable, in whole or in part, the
court or tribunal so holding shall reform the provision to make it enforceable while maintaining
the spirit and goal of the provision. If the court or tribunal determines it cannot so reform the
provision, such provision or part thereof shall be treated as severable, so that the remainder of
the Agreement remains valid.




Section 23 — BANKRUPTCY



In the event that VOLCANO ceases to do business, files a petition under the bankruptcy or
insolvency laws of any jurisdiction, or makes an assignment for the benefit of creditors, and the
Licensed Technology and Licensed Patents cease to be exploited and/or efforts to commercialize them
as contemplated hereunder cease for a period of six- (6) months, then CCF shall have the right to
terminate this Agreement upon written notice.





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Section 24 — FURTHER ASSURANCES



Each party agrees to perform any further acts and to sign and deliver any further documents that
are reasonably necessary to effectuate the provisions of this
Agreement.




Section 25 — NOTICES



Any notice, request, demand or statement or other writing under this Agreement shall be deemed
given and made upon the parties when personally received, delivered by first class certified or
registered mail, postage prepaid, or delivered by overnight express courier to the addresses set
out below or to such other addresses of which the parties receive
written notice.




If from VOLCANO to CCF:




For scientific or technical issues:




D. Geoffrey Vince, Ph.D.

The Cleveland Clinic Foundation

Department of Biomedical Engineering / Mailcode ND20

9500 Euclid Avenue

Cleveland, OH 44195

Tel: (216) 444-1211

E-mail: vince@bme.ri.ccf.org




For legal, intellectual property or technology transfer issues:




Mark G.
Bloom, Esq.

CCF Innovations / Mailcode ND40

9500 Euclid Avenue

Cleveland, OH 44195

Tel: (216) 445-6514

E-mail: bloomm@ccf.org




For Use of Name or Endorsements pursuant to Section 20:




Director

Public and Media Relations / Mailcode H10

9500 Euclid Avenue

Cleveland, OH 44195




With a
copy to: Mark G. Bloom, Esq. / Mailcode ND40




If from
CCF to VOLCANO:




Scott Huennekens

Volcano Therapeutics, Inc.

26061 Merit Circle, Suite 103

Laguna Hills, CA 92635




Page 11 of 16





 









 







Section 26 — GENERAL PROVISIONS



1. No
agency, joint venture or partnership shall be created by this Agreement.



2. VOLCANO may assign the license in connection with the sale or transfer of all or
substantially all the rights of VOLCANO relating to the Licensed Products or services utilizing
the methods within the Licensed Patents.



3. By entering into this Agreement, the parties specifically intend to comply with all
applicable US laws, rules and regulations, including (i) the
federal anti-kickback statute (42
U.S.C.§ 1320a-7(b)) and the related safe harbor regulations; and (ii) the Limitation on Certain
Physician Referrals, also referred to as the “Stark Law”
(42 U.S.C.§1395nn). Accordingly, no
part of any consideration paid hereunder is a prohibited payment for
the recommending or
arranging for the referral of business or the ordering of items or services; nor are the payments
intended to induce illegal referrals of business. In the event that any part of this Agreement is
determined to violate US federal, state, or local laws, rules, or regulations, the parties agree to
negotiate in good faith revisions to the provision or provisions,
which are in violation. In the
event the parties are unable to agree to new or modified terns as required to bring the entire
Agreement into compliance, either party may terminate this Agreement on sixty- (60) days
written notice to the other party.



4. By signing this Agreement, each party agrees that the other shall have the right to
automatically terminate this Agreement in the event that the non-terminating party is debarred,
excluded, suspended or otherwise determined to be ineligible to participate in US federal health
care programs (collectively, “Debarred” or
“Debarment”). Accordingly, each party shall provide
the other with immediate notice if the notifying party becomes
Debarred. Upon receipt of such
notice from such debarred party, this Agreement shall automatically terminate without further
action or notice.



5. This Agreement shall be governed by and construed in accordance with the laws of the
State of California, without resort to choice of law provisions, and the parties agree that it is
executed and delivered in that State. In the event any legal action becomes necessary to enforce
or interpret the terms of this Agreement or arbitration awards related to this Agreement, the
parties agree that such action shall be brought in the United States District Court for the Central
District of California, or in the State Court for the County of Los Angeles, California, and the
parties hereby submit to the jurisdiction of these courts. In any litigation to enforce or
interpret the terms of this Agreement, the prevailing party shall be entitled, ‘in addition to its court
costs, to such reasonable attorneys’ fees, expert witness fees, and any other litigation expenses as shall be
fixed by a court of competent jurisdiction.



6. This Agreement, excepting any Non-Disclosure Agreements between the parties,
constitutes the entire understanding and agreement of the parties with respect to the subject
matter hereof, and there are no representations, warranties, promises or undertaking related to the
subject matter hereof other than those contained herein. As to the subject matter hereof, this
Agreement supersedes and cancels any and all other agreements, excepting any Non-Disclosure
Agreements, between the parties hereto.




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7. No course of dealing between the parties shall act as a modification, estoppel or waiver
of any provision of this Agreement, and no waiver or modification of any term or provision of this
Agreement shall be valid, unless contained in a single written
document signed by both parties.



8. Sections of this Agreement may be provided with heading or captions for the
convenience of the reader. These headings or captions form no real part of the Agreement and
shall not be used to interpret or construe this Agreement or limit or alter the meaning of the
terms of this Agreement in any way.



9. This Agreement document may be executed as one or more counterparts, each of which
shall be deemed an original but all of which together shall constitute one and the same integrated
Agreement document.



10. Any delay in or failure of performance by either party under this Agreement will not be
considered a breach of this Agreement if caused by events beyond the reasonable control of that
party (force majeure events), including acts of God, embargoes, governmental restrictions,
strikes, riots, wars or other military actions, civil disorders, rebellion, terrorist activities,
vandalism and sabotage. The party whose performance is affected by force majeure events will
promptly notify the other party, giving details of the force majeure circumstances, and
obligations of the party giving the notice will be suspended during (but not longer than) the
continuance of the force majeure.




Page 13 of 16





 










 






IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set
forth above.




	 	 	 	 	 	 	 
	THE CLEVEL AND CLINIC FOUNDATION:	 	 	 	 
	 
	 	 	 	 	 	 
	
	 	 	 	 	 	 
	By:
	 	/s/ Frank L. Lordeman	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	Frank L. Lordeman	 	 	 	 
	 

	 	Chief Operating Officer	 	 	 	 
	 
	Date:

	 	          5-1-02	 	 	 	 
	 
	 	 	 	 	 	 
	VOLCANO THERAPEUTICS, INC.:	 	 	 	 
	 
	 	 	 	 	 	 
	
	 	 	 	 	 	 
	By:
	 	/s/ Scott Huennekens	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	Scott Huennekens	 	 	 	 
	 

	 	Chief Executive Officer	 	 	 	 
	 
	Date:

	 	          5-3-02	 	 	 	 
	 
	 	 	 	 	 	 
	Acknowledged (not a signatory):	 	 	 	 
	 
	 	 	 	 	 	 
	
	 	 	 	 	 	 
	By:
	 	/s/ Linda Graham	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	Linda Graham, M.D.	 	 	 	 
	 

	 	Acting Chair	 	 	 	 
	 

	 	Dept. of Biomedical Engineering	 	 	 	 
	 
	Date:

	 	          5-2-02	 	 	 	 
	 
	 	 	 	 	 	 
	Approved as to Form (not a signatory):	 	 	 	 
	 
	 	 	 	 	 	 
	
	 	 	 	 	 	 
	By:

	 	/s/ Mark G. Bloom	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	Mark G. Bloom, Esq.	 	 	 	 
	 	 	Manager of Technology Licensing	 	
	 	 	and Chief Patent Counsel	 	APPROVED AS TO FORM
	 	 	CCF Innovations	 	          CCF-OFFICE OF
	 	 		 	     GENERAL COUNSEL
	Date:

	 	          4-30-02
	 	BY
	 	/s/ Dave Meyer
	 

	 	 	 	 	 	 
	 
	 

	 	 	 	DATE
	 	          4-30-02






Page 14 of 16









 






EXHIBIT A



1. CCF Case No. 99149 now issued as United States Patent No. 6,200,268, issued March
13, 2001, and entitled “VASCULAR PLAQUE CHARACTERIZATION.”



2. CCF Case No. 99040 entitled “INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR
METHOD AND SYSTEM” PCT/US00/17241 (WO 01/01864).




Page 15 of 16









 








EXHIBIT B



1. CCF Contact Personnel — To Be Provided



2. VOLCANO Contact Personnel — To Be Provided



3. PD Plan — To Be Provided





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