1
Exhibit 10.35
LICENSE AGREEMENT
This License Agreement ("Agreement") is made as of the 28 day of July, 1999
(the "Effective Date") by and between Radiance Medical Systems, Inc., a
Delaware corporation ("RMS") with its principal place of business located at
00000 Xxxxx Xxxxxxx, Xxxxxx, Xxxxxxxxxx, Xxxxxx Xxxxxx, 00000 and BEBIG GmbH,
("BEBIG") with its principal place of business located at Xxxxxx-Xxxxxx-Xxx.
00, 00000 Xxxxxx, Xxxxxxx.
WHEREAS, BEBIG has developed and owns certain proprietary processes and
materials from the manufacture of medical devices for the delivery of radiation
therapy to the human body;
WHEREAS, BEBIG is the exclusive licensee of the Hehrlein Patents (as
defined below);
WHEREAS, RMS desires to acquire a license to such technology and a
sublicense to such patents for the development, manufacture and
commercialization of medical devices for the delivery of radiation therapy to
the human body; and
WHEREAS, BEBIG is willing to grant such license and sublicense upon the
terms and subject to the conditions set forth herein.
NOW THEREFORE, in consideration of the mutual promises, covenants,
representations and warranties contained in this License Agreement, the parties
agree as follows:
1. DEFINITIONS.
The following capitalized terms shall have the meanings given below:
1.1 "Affiliate" shall mean, with respect to any Person, any other
Person which controls, is controlled by, or is under common control with the
first Person. For purposes of this definition, "control" means: (a) in the case
of corporate entities, direct or indirect ownership of more than fifty percent
(50%) of the stock or shares entitled to vote for the election of directors;
and (b) in the case of non-corporate entities, direct or indirect ownership of
more than fifty percent (50%) of the equity interest with the power to direct
the management and policies of such non-corporate entities.
1.2 "Effective Date" shall have the meaning set forth in the
Preamble to this License Agreement.
1.3 "Field" shall mean the design, development and commercialization
of medical devices suitable for the radioactive treatment of occlusive
cardiovascular and peripheral vascular diseases.
1.4 "Hehrlein license" shall mean that certain Patent License
Agreement between Xx. Xxxxxxxxx Xxxxxxxx and BEBIG dated October 26, 1998.
1.5 "Hehrlein Patents" shall mean all patents, pending patent
applications and improvements related to be "C. Hehrlein Balloon-Based Radiation
Delivery Devices" as more fully described on Exhibit A.
2
1.6 "Licensed Know-How" means information regarding methods and devices
for the radioactive treatment of occlusive cardiovascular and peripheral
vascular disease related to the Licensed Patents now existing or hereafter
developed which is either confidential or not known or used by others who do
not have licenses for such use, including, but not limited to, devices,
specifications, methods of use, inventions and technical, business, design,
manufacturing, bench, animal, clinical and the like information.
1.7 "Licensed Patents" means (1) the patent rights owned or controlled or
licensed by BEBIG or its Affiliates in the patents and patent applications
identified on Exhibit A attached hereto, and the inventions covered by those
applications and patents, and foreign counterparts thereof, and (ii) any
additional patent rights BEBIG or its Affiliates now owns, controls or has
access to, or may own, control or have access to in the future which are
continuations, continuations-in-part, divisionals or refilings of the original
applications upon which the aforementioned patent rights are based, and the
inventions covered thereby, or foreign counterparts thereof, and upon any
reexaminations, reissues, renewals or extensions thereof.
1.8 "Licensed Product" shall mean a product, that incorporates, embodies,
uses or is designed or produced using the Licensed Technology or Licensed
Know-How.
1.9 "Licensed Technology" shall mean the Licensed Patents and the
Licensed Know-How.
1.10 "Manufacturing Agreement" shall mean that certain facility set-up and
contract manufacturing Agreement by and between BEBIG and RMS of even date
herewith.
1.11 "Net Sales" shall mean the amount invoiced for sales, leases or other
dispositions of Licensed Products (other than sales, leases or other
dispositions to Affiliates unless such Affiliate is the end user) less the
following deductions (to the extent they are not already reflected in the
amount billed):
(a) Discounts taken in amounts customary in the trade;
(b) Import, export, excise, sales or use taxes, tariffs and duties
directly imposed with reference to particular sales;
(c) Outbound transportation prepaid or allowed; and
(d) Amounts allowed or credited on returns, rebates or retroactive
price deductions.
Licensed Products shall be considered "sold" when billed out or
invoiced to a third party. If a Licensed Product is incorporated into another
product or is sold in combination with other products or services and not
invoiced separately, such Licensed Product shall be included in Net Sales at
the then current list price for such quantities of such Licensed Product with
any discount from list price being applied proportionately to the discount from
list price of the product into which the Licensed Product was incorporated or
the list price of the other products sold, as the case may be. If there is no
then current list price for such Licensed Product, Net Sales will be based on
the separate value of such Licensed Product and such other products or
services, but in no event shall the
2
3
value of such Licensed Product for such calculation be less than RMS's cost of
goods for such Licensed Product, determined in accordance with generally
accepted accounting principles.
1.12 "Person" shall mean any person, corporation, organization, body
or other legal entity.
1.13 "Valid Claim" means a claim of an issued patent that has not been
held or declared invalid, unpatentable or unenforceable by the relevant national
patent office or a court of competent jurisdiction, unappealable or unappealed
within the time allowed for appeal, and which has not been admitted to be
invalid or unenforceable.
2. LICENSE TERMS.
2.1 License Grant to RMS. Subject to the terms and conditions of this
License Agreement, BEBIG hereby grants to RMS a worldwide, non-exclusive license
under the Licensed Technology, including a sublicense under the Hehrlein
license, to practice methods and to design, develop, manufacture, have
manufactured, import, export, use, offer to sell, sell and otherwise dispose of
License Products in the Field.
2.2 Sublicensees. RMS shall give BEBIG notice of any sublicense
granted by RMS. RMS shall be responsible for all obligations of such
sublicensees hereunder, including without limitation their obligation to
maintain confidentiality of information and to report Net Sales and to pay
royalties on sales of Licensed Products.
2.3 Hehrlein License Maintenance. BEBIG shall perform all of its
obligations under the Hehrlein License and use its best efforts to maintain the
Hehrlein license in full force and effect for the entire term of this Agreement,
as it may be extended. In the event that despite such best efforts, BEBIG knows
or has reason to believe that the Hehrlein License will be terminated, it shall
provide prompt notice to RMS and shall cooperate with RMS in maintaining the
Hehrlein License in effect, which cooperation may include assignment of the
Hehrlein License to RMS or the loan or other advancing of funds to BEBIG to meet
its financial or other obligations under the License.
3. TERM.
3.1 Term. The initial term of this License Agreement (the "Initial
Term") shall commence as of the Effective Date, and shall continue until July 1,
2002.
3.2 Option to Renew. Upon the expiration of the Initial Term of this
License Agreement, RMS has the option to extend this License Agreement until
the expiration of all Licensed Patents hereunder, unless earlier terminated
pursuant to Section 8 (the "Option Period"). RMS shall notify BEBIG of its
option to extend this License Agreement, pursuant to Section 10.9, no later
than July 1, 2002.
3
4
4. LICENSE FEES
4.1 Closing Fee. Within fifteen (15) days of the Effective Date of
this License Agreement, RMS shall pay to BEBIG a one time license and option
fee of [ * ] (the "Closing Fee").
4.2 Annual Fee. Subject to the provisions set forth in Section 4.3,
during the Initial Term of this License Agreement, RMS shall pay to BEBIG an
aggregate amount of [ * ] payable in three annual installments (the
"Annual License Fee"). Each Annual License Fee shall be [ * ], less any
License Fee Offset as set forth in Section 4.4. The first Annual License Fee is
payable July 1, 2000, and each subsequent Annual License Fee is payable at one
year intervals thereafter.
4.3 Royalties. Subject to the provisions set forth in Section 4.3(b)
and 4.4, if RMS exercises its option to extend this License Agreement pursuant
to Section 3.2, the consideration payable to BEBIG during the Option Period
(the "Royalties") shall be as follows:
(a) Royalty Rate. RMS shall pay to BEBIG (i) a royalty of [*]
percent[*] of Net Sales of Licensed Products if the sales would infringe a Valid
Claim of the German Licensed Patent [ * ], no matter what country the
Licensed Product is sold in (i.e., BEBIG shall be entitled to royalties on
worldwide Net Sales so long as the Licensed Product is covered by a Valid Claim
of the German Licensed Patent [ * ]), and (ii) no royalties if such
sales would not infringe a Valid Claim of the German Licensed Patent [ *
] Such Royalties shall be subject to adjustments as set forth in Sections 4.3(b)
and 4.4 below.
(b) Adjustment of Royalty Rate. In the event that BEBIG
licenses or sublicenses the Licensed Technology to a third party, the Royalties
otherwise payable under Section 4.3(a) above shall be reduced by [ * ] percent
[ * ] to a royalty rate of [ * ] percent [ * ] of Net Sales of Licensed
Products.
(c) Payment Dates and Statements. Within ninety (90) days of
the end of each calendar quarter in which Net Sales occur, RMS shall calculate
the Royalties owed to BEBIG under this Section 4 and shall remit to BEBIG the
amount owed to BEBIG. Such payment shall be accompanied by a statement showing
the calculation of the amount owed for Licensed Products, including the Net
Sales of Licensed Products for that quarter (including the gross invoiced sales
and permissible deductions therefrom), and the exchange rate (as determined
pursuant to Section 4.6) used to directly convert any royalty amounts into U.S.
Dollars.
(d) Records and Accounting. RMS shall keep complete and
accurate records of the latest three (3) years of Net Sales. BEBIG shall have
the right annually at its own expense to have an independent, certified public
accountant review such records upon at least twenty (20) days' notice and
during reasonable business hours for the purpose of verifying Royalties payable
to BEBIG. Such review shall be conducted so as not to unreasonably interfere
with RMS's operations. Such accountant shall agree to appropriate
confidentiality provisions and transmit to BEBIG only the results of its review
and items necessary to show any discrepancy between RMS's reports. Results of
such review shall be made available to both parties. If the review results in a
determination of an underpayment of royalties to BEBIG, such underpayment shall
be promptly
[*] Confidential Portions Omitted and Filed Separately with the Commission.
4
5
remitted to BEBIG with interest as provided in Section 4.5. If such review
determines that RMS' Net Sales were more than 110% of the Net Sales reported by
RMS for the period under review, RMS shall pay all of the reasonable costs of
such review.
4.4 License Fee Offset. The Annual License Fee and the Royalties are
subject to the following offsets (each, a "License Fee Offset"):
(a) the Closing Fee of [*];
(b) all payments by RMS to BEBIG and its Affiliates, or paid by
RMS for the account of BEBIG, including, but not limited to those related to or
incurred in the performance of the Manufacturing Agreement such as {*} in
service expenses; and revenues paid to BEBIG for the production of the Licensed
Products, minus the amount expended for equipment purchases by BEBIG from RMS;
(c) amounts expended by RMS in the enforcement of intellectual
property rights pursuant to Section 6.3; and
(d) amounts expended by RMS in obtaining or maintaining its
rights to the Licensed Patents and/or Licensed Technology pursuant to Section
6.2.
Such License Fee Offsets will be applied to either the Annual License Fee
or Royalties, whichever is then applicable, on the date the same is paid or
incurred by RMS. Each License Fee Offset is accrued and cumulative over the
period this License Agreement is in effect, and any excess License Fee Offset
not used shall be retained and used as an offset to a subsequent payment due
hereunder.
4.5 Late Payments. Any payment owed by BEBIG under this License
Agreement that is not paid on or before the date such payment is due shall bear
interest, to the extent permitted by applicable law, at [*] percent [*] per
annum, calculated on the number of days such payment is delinquent.
4.6 Currency of Payments. All payments under this License Agreement
shall be made U.S. Dollars by wire transfer to such bank account as BEBIG may
designate from time to time. Any payments due hereunder on Net Sales outside of
the United States shall be payable U.S. Dollars at the average rate of exchange
of the currency of the country in which the Net Sales are made as reported in
the New York edition of The Wall Street Journal for the last month of the
quarter for which the royalties are payable.
4.7 Blocked Currency. If the law or regulation of any country shall
at any time operate to prohibit the transfer of funds therefrom to BEBIG, RMS
shall notify BEBIG to such effect and (provided that RMS shall first attempt in
good faith to follow BEBIG's instructions pursuant to the first sentence of
Section 4.6) shall have the right to pay or cause to be paid royalties
hereunder on account of its sales and the sales of its Affiliates and
sublicensees in such country by depositing local currency (if RMS is paid in
such currency) to the account of BEBIG in an interest-bearing account if
permissible at the prevailing commercial interest rate in a bank in such
country (which account and bank are reasonably acceptable to BEBIG). RMS shall
thereafter cooperate with BEBIG in
[*] Confidential Portions Omitted and Filed Separately with the Commission.
5
6
BEBIG's efforts to obtain the lawful release of said funds to BEBIG, but shall
have no further responsibility therefor.
4.8 Tax Withholding. If laws or regulations require the withholding
of income taxes owed by BEBIG on account of royalties accruing under this
License Agreement, such taxes shall be deducted on a country-by-country basis
by RMS from such remittable royalty and will be paid by it to the proper taxing
authority. Proof of payment shall be secured and sent to BEBIG as evidence of
such payment.
4.9 Other Taxes. RMS shall pay all sales, use, transfer or similar
taxes, whether foreign, federal (United States), state or local, however
designated, that are levied or imposed by reason of the sale or transfer of
Licensed Products contemplated hereby, and any penalties, interest and
collection or withholding costs associated with any of the foregoing items,
excluding, however, taxes accruing to BEBIG under applicable law.
5. TRANSFER OF TECHNOLOGY.
5.1 Transfer of Technology. Within forty-five (45) days of the
Effective Date, BEBIG will supply RMS with such information and materials in
its possession relating to the Licensed Materials which is reasonably necessary
or useful to enable RMS to develop, design, [manufacture, have manufactured],
use and sell Licensed Products in the Field. Thereafter, BEBIG shall supply
such assistance as is reasonably requested by RMS, subject to the parties
agreement regarding payment therefor.
5.2 Periodic Review; Consultation. During the development and
manufacture of Licensed Products, the parties shall consult regularly with one
another and keep each other generally informed of progress. Each party shall
designate an authorized representative (and "Authorized Representative") who
shall oversee the day-to-day operation of the rights and obligations of each
such party under this Agreement. Either party may change its Authorized
Representative by giving the other party written notice of its new
representative in the manner provided herein. The Authorized Representatives
shall meet at least once per calendar year to review progress on the
development of Licensed Products. Such meetings will take place at a mutually
agreeable time and place and may be attended by other employees or consultants
of the parties.
6. INTELLECTUAL PROPERTY.
6.1 Ownership of Intellectual Property. Except to the extent
licenses or rights are granted herein, BEBIG retains the entire right, title
and interest in and to the Licensed Technology, RMS and BEBIG shall each own,
and have the right to apply for patents with respect to any inventions made
solely by its respective employees. RMS and BEBIG shall jointly own any
inventions made jointly by employees of both parties. In such event, the parties
shall cooperate to obtain patent protection on such joint inventions as they may
reasonably determine and shall share equally the costs thereof (provided
however, that if BEBIG's interest in such joint invention is included in the
Licensed Technology and licensed to RMS hereunder, BEBIG shall pay all the
costs of obtaining patent protection). In the event one party does not wish to
obtain such patent protection of a joint invention, the other party may seek
such patent protection in its own name only, with all rights in such joint
invention being assigned to such party.
6
7
6.2 Patent Prosecution. BEBIG shall file, prosecute and maintain the
Licensed Patents. BEBIG shall periodically confer with RMS regarding its
planned patent activities, and shall reasonably consider RMS' requests with
respect thereto. In the event BEBIG determines not to file, prosecute or
maintain any Licensed Patent in any jurisdiction or jurisdictions, BEBIG shall
notify RMS of such determination at least ninety (90) days prior to any
applicable deadline. If BEBIG makes such determination, RMS may elect to file,
prosecute or maintain any such Licensed Patent in such jurisdiction at its own
expense, and BEBIG shall provide reasonable assistance. In such event, RMS may
deduct from amounts payable to BEBIG hereunder, as a License Fee Offset, its
expenses in filing, prosecuting and maintaining such Licensed Patents.
6.3 Enforcement of Intellectual Property Rights. In the case of any
infringement of any Licensed Patents or other violation of any intellectual
property rights contained in the Licensed Technology by any third party during
the term of this License Agreement, BEBIG shall have the right, at BEBIG's
expense, to cause such party to cease such infringement and to otherwise
enforce such Licensed Patent or such other intellectual property rights. RMS
shall assist BEBIG as reasonably requested in taking any such actions against
any such infringer. Should BEBIG fail to take action within sixty (60) days
after having been notified of any alleged infringement or violation, and
provided that such infringement has occurred in the Field, RMS may, upon notice
to BEBIG, take any steps RMS may deem appropriate against such infringer at
RMS' own expense. BEBIG shall assist RMS as reasonably requested in taking any
such action against any such infringer. Any amount recovered as a result of any
action taken by BEBIG or RMS hereunder shall be first applied to reimbursing the
party taking such action for its out-of-pocket expenses, and then to
reimbursing the other party for its out-of-pocket expenses, if any. In the event
that RMS does not recover its expenses, any amount not recovered shall be
considered as a License Fee Offset as against amounts payable to BEBIG under
this License Agreement pursuant to Section 4.4.
6.4 Invalidity or Non-Infringement Action. In the event that a
declaratory judgment action alleging invalidity or non-infringement of any of
the Licensed Patents shall be brought against either party, and in such event
BEBIG does not elect to defend against such action, BEBIG shall notify RMS and
RMS, at its option, shall have the right, within thirty (30) days after such
notice from BEBIG, to intervene and take over the defense of the action at its
own expense; provided that RMS shall consult with BEBIG on material aspects of
such litigation and provided further that RMS shall select counsel to which
BEBIG has no reasonable objection. No settlement, consent judgment or other
voluntary final disposition of the suit may be entered into without the consent
of BEBIG, which consent shall not be unreasonably withheld or delayed.
6.5 Abandonment of Suit. Should BEBIG or RMS commence or defend a
suit under the foregoing provisions and thereafter elect to abandon the same,
the abandoning party shall give timely written notice to the other party and
such other party may continue prosecution of such suit, with the expenses and
recovery being allocated as set forth in Section 6.3.
6.6 Alleged Infringement. If, during the term of this License
Agreement, any third party (other than an Affiliate of a party) claims that
RMS' making, using or selling of Licensed Products hereunder infringes on a
third-party patent, or other proprietary rights of a third party as a result of
the use of the Licensed Patents and/or the Licensed Technology, within one
hundred and twenty (120) days after notice by RMS, BEBIG shall either (i)
procure for RMS the right to exercise all rights licensed under this License
Agreement without any additional payment therefor by RMS.
7
8
or (ii) advise RMS that it elects not to procure such rights itself. If BEBIG
does not procure such right within such 120-day period after notice of such
claim by RMS, RMS shall have the right, but not the obligation, to procure such
rights itself. RMS shall be entitled to offset any expenses or costs it incurs
in obtaining or maintaining such rights as an License Fee Offset as against
amounts payable to BEBIG under this License Agreement pursuant to Section 4.4.
6.7 Cooperation. In the event of any action against or by a third
party, the party not bringing or defending such suit shall cooperate in all
respects, execute any documents reasonably necessary to permit the other party
to prosecute or defend such suit, and to the extent reasonable shall make
available its employees and relevant records to provide evidence for such suit.
6.8 Intellectual Property Representations and Warranties. BEBIG
represents, warrants and covenants to RMS, as of the Effective Date, as follows:
(a) It is the sole and exclusive owner of the entire right,
title and interest in the Licensed Patents and Licensed Technology (subject to
the [ * ]), with the right to license the same to RMS, free and clear of all
encumbrances, liens, claims, licenses and security interests of any kind and has
not exclusively licensed the same to any third party.
(b) It is the sole and exclusive license of the [ * ] Patents
under the [ * ], such license is in full force and effect and neither BEBIG or
[ * ] is in breach thereof, and a true copy of such license has been delivered
to RMS.
(c) There are no actions, suits or proceedings pending or, to
BEBIG's knowledge, threatened against BEBIG or any of its Affiliates, at law or
in equity before any court or administrative office or agency which affect the
use of the Licensed Patents or the Licensed Technology by RMS hereunder.
(d) Each of the patents in the Licensed Patents is valid and in
good standing and each of the patent applications included in the Licensed
Patents is currently pending and in good standing, and has not been abandoned.
(e) To BEBIG's knowledge, the practice by RMS of the Licensed
Technology, and the activities of BEBIG under the Development and Manufacturing
Agreement, will not violate the patent or other proprietary rights of any third
party.
7. CONFIDENTIAL INFORMATION
7.1 Confidentiality. RMS and BEBIG realize that some information
received by one party from the other pursuant to this License Agreement will be
confidential. It is therefore agreed that any information received by one party
from the other which is in writing or promptly reduced to writing shall not be
disclosed by the receiving party to any third party and shall not be used by
the receiving party for purposes other than those contemplated by this License
Agreement for a period of three (3) years from and after the date such
information is disclosed. The receiving party shall use the same degree of care
with respect to such information that it uses with respect to its own
information which it intends to maintain proprietary and confidential. Except
as expressly granted herein, nothing in this License Agreement shall be
construed to grant either party any license or other right to the confidential
information or proprietary information (including but not limited to
[*] Confidential Portions Omitted and Filed Separately with the Commission.
8
9
patents, patent applications, know-how, trade secrets and copyrighted works of
the other party. However, nothing in this License Agreement shall prevent the
receiving party from exercising any legal rights to use, disclose, duplicate,
or publish any such information:
(a) which was in the public domain at the time of the disclosure to
the receiving party, or which thereafter fell into the public domain without
any fault of the receiving party;
(b) which the receiving party rightfully had in its possession prior
to the disclosure as evidenced in writing;
(c) which the receiving party lawfully obtained without restriction
from a third party who is not under any confidentiality obligations to the
disclosing party;
(d) which, in the case of an oral disclosure, shall not have been
subsequently disclosed in writing to the receiving party within thirty (30)
days after such oral disclosure;
(e) which is developed by the receiving party independently of such
disclosure; or
(f) which is inherently or necessarily disclosed to the public by
the display or commercial sale of any product or system, by the issuance of a
related patent or in compliance with the lawful requirements of the Department
of Health and Human Services of the United States.
7.2 Confidentiality Agreements. Each party shall maintain agreements with
their respective employees and representatives providing for confidentiality
and non-use commitments consistent with its obligations hereunder and will
require all of their employees, consultants, clinical collaborators, agents or
others who have access to any such confidential information of the other party
to execute confidentiality and non-use agreements covering such confidential
information subject to Section 6 and will exercise its reasonable best efforts
to obtain compliance therewith.
7.3 No Disclosure Without Consent Or Legal Requirement. Neither party
shall release any information to any third party with respect to the terms or
existence of this License Agreement without the prior written consent of the
other party (which consent shall not be unreasonably withheld). This prohibition
includes, but is not limited to, press releases, educational and scientific
conferences, promotional materials, and disclosures to (or disclosures with)
the media. It is understood, however that the parties shall have the right to
provide required information concerning this License Agreement to investors and
potential investors, and to Affiliates in order to enable them to carry out the
activities contemplated hereunder. In addition, each party may, in its
reasonable judgment, disclose such information as may be required by law. Each
party agrees to notify the other party of its intention to disclose such
information to a third party (but not the identity of the third party). Neither
party shall use the name of the other party in any publication or promotional
material or in any form for public distribution without the prior written
consent of the other party.
9
10
8. TERMINATION.
8.1 Default and Effects Thereof. Upon any failure of either party to
comply with its obligations under the License Agreement in any material respect
which shall continue for more than sixty (60) days after notice thereof from
the non-defaulting party to the defaulting party, the non-defaulting party
shall be entitled, without prejudice to any of its other rights under this
License Agreement, and in addition to any other remedies available to it by law
or in equity, to terminate this License Agreement by giving notice to that
effect to the defaulting party. The right of either party to effect such
termination of such license shall not be affected in any way by its waiver or
failure to take action with respect to any previous default with respect to this
License Agreement.
8.2 Insolvency or Bankruptcy. Either party may, in addition to any
other remedies available to it by law or in equity, terminate this License
Agreement by written notice to the other party in the event (i) the other party
shall have become insolvent or bankrupt, or shall have made an assignment for
the benefit of its creditors, or (ii) there shall have been appointed a trustee
or receiver of the other party or for all or a substantial part of its
property, or (iii) any case or proceeding shall have been commenced or some
other action taken by or against the other party in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up, arrangement, composition
or readjustment of its debts or any other relief under any bankruptcy,
insolvency, reorganization or other similar act of law of any jurisdiction now
or hereafter in effect or there shall have been issued a warrant of attachment,
execution, distraint or similar process against any substantial part of the
property of the other party, and any such event or action shall have continued
for ninety (90) days undismissed, unbounded and undischarged; provided,
however, that no such right to terminate shall pertain solely by virtue of a
voluntary reorganization for the purpose of solvent amalgamenation or
reconstruction.
8.3 Effect of Termination. Upon termination of this License Agreement
for any reason:
(a) Neither party shall be released from any obligation that
matured prior to the effective date of such termination.
(b) Each party will return and deliver to the other party all
materials and documents containing Confidential Information of the other party.
(c) The provisions of Sections 7 and 9 shall survive any
termination of this License Agreement or any license hereunder for a period of
three (3) years.
(d) In the case of expiration of this License Agreement
resulting from expiration of all Licensed Patents, RMS shall retain a
non-exclusive, fully-paid, worldwide, perpetual license to exploit the Licensed
Technology in the Field.
9. INDEMNIFICATION.
9.1 Indemnification of BEBIG. RMS will indemnify and hold BEBIG
harmless against all actions, suits, claims, demands, or prosecutions
("claims") that may be brought or instituted against BEBIG arising from RMS'
exploitation of the license granted to hereunder except to
10
11
the extent such claims from the negligence or the breach by BEBIG of its
obligations hereunder or the License, Development and Manufacturing Agreement.
BEBIG will promptly notify RMS within a reasonable time after it
become aware of any claim, action or proceeding that may be subject to
indemnification pursuant to this Section 9.1 and will cooperate with and
authorize RMS to carry out the sole management and defense of such claim,
action or proceeding with counsel reasonably acceptable to BEBIG. BEBIG will
not compromise or settle any claim, action or proceeding subject to
indemnification without the prior written approval of RMS.
9.2 Idemnification by RMS. BEBIG shall defend, indemnify and hold
RMS harmless from and BEBIG shall defend or settle, any claim, demand, action,
proceeding or suit against RMS, its Affiliates or sublicensees arising out of
any breach of BEBIG's covenants, representations and warranties herein.
10. MISCELLANEOUS PROVISIONS
10.1 No Partnership. Nothing in this License Agreement is intended
or shall be deemed to constitute a partnership, agency, employer, employee or
joint venture relationship between the parties. Neither party shall incur any
debts or make any commitments for the other.
10.2 Assignments. Except as otherwise provided herein, neither this
License Agreement nor any interest hereunder shall be assignable by either
party by operation of law or otherwise without the prior written consent of the
other (which shall not be unreasonably withheld), provided, however, that no
consent shall be required for any assignment of this License Agreement by
either party in connection with the transfer of substantially all of its
business to which this License Agreement relates.
10.3 Force Majeure. Neither party shall be liable to the other for
loss or damages or shall have any right to terminate this License Agreement for
any default or delay attributable to any act of God, earthquake, flood, fire,
explosion, strike, lockout, labor dispute, casualty or accident, war,
revolution, civil commotion, act of public enemies, blockage or embargo,
injunction, law, order, proclamation, regulation, ordinance, demand or
requirement of any government or subdivision, authority (including, without
limitation, medical device regulatory authorities) or representative of any
such government if the party affected shall give prompt notice of any such
cause to the other party. The party given such notice shall thereupon be
excused from such of its obligations hereunder as it is so disabled from
performing. Notwithstanding the foregoing, nothing in this Section shall excuse
or suspend the obligation to make any payment due hereunder in the manner and
at the time provided.
10.4 No Trademark Rights. Except as set forth above, no right,
express or implied, is granted by this License Agreement to use in any manner
any trade name or trademark of BEBIG or RMS in connection with the performance
of this License Agreement or the exploitation of any license granted hereunder.
10.5 Public Announcements. Copies of press releases or similar
written communications containing a party's name shall be provided to that
party for approval prior to release.
11
12
10.6 Entire Agreement of the Parties; Amendment. This License Agreement
constitutes and contains the entire understanding and agreement of the parties
and cancels and supersedes any and all prior negotiations, correspondence and
understandings and agreements, whether verbal or written, between the parties
respecting the subject matter hereof. No waiver, modification or amendment of
any provision of this License Agreement shall be valid or effective unless made
in writing and signed by a duly authorized officer of each of the parties.
10.7 Severability. In the event any one or more of the provisions of this
License Agreement should for any reason be held by any court or authority having
jurisdiction over this License Agreement or either of the parties to be invalid,
illegal or unenforceable, such provision or provisions shall be validly reformed
by addition or deletion of working as appropriate to avoid such result and as
nearly as possible approximate the intent of the parties and, if unreformable,
shall be divisible and deleted in such jurisdiction; elsewhere, this License
Agreement shall not be affected.
10.8 Captions. The captions to this License Agreement are for convenience
only, and are to be of no force or effect in construing or interpreting any of
the provisions of this License Agreement.
10.9 Notice and Delivery. Any notice, requests, delivery, approval or
consent required or permitted to be given under this License Agreement shall be
in writing and shall be deemed to have been sufficiently given if delivered in
person, transmitted by internationally recognized courier or telecopier (with
confirmed answer-back) to the party to whom it is directed at its address shown
below or such other address as such party shall have last given by notice to the
other party.
If to RMS, addressed to:
Radiance Medical Systems, Inc.
00000 Xxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, Xxxxxxxxxx 00000
Telephone: 000-000-000-0000
Telecopier: 000-000-000-0000
Attention: Chief Executive Officer
If to BEBIG, addressed to:
BEBIG GmbH
Xxxxxx-Xxxxxx-Xxx. 00,
00000 Xxxxxx, Xxxxxxx
Telephone: 000-00-00-00-00-0000
Telecopier: 011-49-30-9410-8412
Attention: General Manager
10.10 LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE LIABLE TO THE OTHER
FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES ARISING
OUT OF ANY OF THE TERMS OR CONDITIONS OF
12
13
THIS LICENSE AGREEMENT OR WITH RESPECT TO THEIR PERFORMANCE OR LACK THEREOF.
10.11 Informal Dispute Resolution. In an effort to resolve informally
and amicably any claim, controversy, or dispute arising out of or related to the
interpretation, performance, or breach of this License Agreement (a "Dispute")
without resorting to litigation, each party shall notify the other party to the
Dispute in writing of any Dispute hereunder that requires resolution. Such
notice shall set forth the nature of the Dispute, the amount involved, if any,
and the remedy sought. Each party shall promptly designate an executive-level
employee to investigate, discuss and seek to settle the matter between them. If
the two designated representatives are unable to settle the matter within thirty
(30) days after such notification, the matter shall be submitted to BEBIG's and
RMS' Chief Executive Officer for consideration. If settlement cannot be reached
through their efforts within an additional thirty (30) days (or such longer time
period as they shall agree upon in writing) then either party may thereafter
take such actions as they deem appropriate. The parties agree that any
applicable statute of limitations shall be tolled during the pendency of such
informal dispute resolution process and that neither party shall raise or
assert any claim of laches or other legal or equitable principle of limitation
or repose of action based upon such process.
10.12 Attorneys' Fees. Except as otherwise provided herein, each party
shall bear its own legal fees incurred in connection with the transactions
contemplated hereby, provided, however, that if any party to this License
Agreement seeks to enforce its rights under this License Agreement by legal
proceedings or otherwise, the non-prevailing party shall pay all costs and
expenses incurred by the prevailing party, including, without limitation, all
reasonable attorneys' fees.
10.13 Governing Law, Venue. This License Agreement shall be governed
by and construed in accordance with the laws of the State of California, United
States, without regard to the conflict of laws provisions thereof, and, subject
to the informal dispute resolution in Section 10.11, all disputes with respect
to this Agreement shall be exclusively heard in the federal or state court, in
Orange County, California.
IN WITNESS WHEREOF, the parties have caused this License Agreement to be
executed by their respective duly authorized officers as of the day and year
first set forth above, each copy of which shall for all purposes be deemed to be
an original.
RADIANCE MEDICAL SYSTEMS, INC.
By: /s/ XXXXXXX X. XXXXXX
-------------------------------------
Name: Xxxxxxx X. Xxxxxx
-------------------------------------
Title: CEO and President
-------------------------------------
BEBIG GmbH
By: /s/ X. XXXXXX
-------------------------------------
Name: X. Xxxxxx
-------------------------------------
Title: General Manager
-------------------------------------
13
14
EXHIBIT A
BEBIG LICENSED PATENTS
----------------------
1. German Patent # DE 19600669 C2
2. PCT Application # WO 96/22121 41
3. All other issued patents and patent applications
licensed to BEBIG dealing with "C. Hehrlein Balloon-Based
Radiation Delivery Devices"
