EXHIBIT 10.1
AGREEMENT
This Definitive Agreement dated as of the 18th day of September, 1998
(the "Effective Date") by and between XXXXXX XXXXXXX, INC., a California
corporation, with offices at 0000 Xxxxxxxxxx Xxxxxx, Xxxxxxx Xxxx, XX 00000
("Xxxxxx Xxxxxxx") and ANGEION CORPORATION, a Minnesota corporation, with
offices at 0000 Xxxxxxxxx Xxxxx, Xxxxxxxx Xxxx, XX 00000 ("Angeion").
Witnesseth:
Whereas, Xxxxxx Xxxxxxx is in the business of manufacturing and selling
medical devices, including cardiac ablation therapy devices; and,
Whereas, Angeion is in the business of developing implantable cardiac
defibrillators and electrophysiology catheters; and,
Whereas, Angeion is the owner of U.S. Patent Nos. 5,462,521, 5,643,197
and 5,800,428 and U.S. Patent Applications, Serial Nos. 08/496,947 and
09/073,651 and corresponding foreign patents and patent applications; and
Whereas, Angeion desires to assign to Xxxxxx Xxxxxxx all of its rights,
title and interest in and to the aforesaid patents, subject to the terms and
conditions hereinafter set forth, and Xxxxxx Xxxxxxx accepts such assignment;
and
Whereas, Xxxxxx Xxxxxxx desires Angeion to perform development work of
the Spot Catheter Product and the Linear Catheter Product (as each are
hereinafter defined); and
Whereas, Angeion is the sponsor and has previously conducted
pre-clinical and clinical studies on the Spot Catheter Product, and Xxxxxx
Xxxxxxx is interested in acquiring rights to all records, data, and analysis and
other information regarding the Spot Catheter Product studies, including but not
limited to, data for submission for regulatory approvals (including
communications to and from the US FDA and any corresponding foreign documents);
and
Whereas, Angeion desires to transfer to Xxxxxx Xxxxxxx the Spot
Catheter Technology and Linear Catheter Technology (as each are hereinafter
defined) and Xxxxxx Xxxxxxx accepts this technology transfer, subject to the
terms and conditions hereinafter set forth.
Now, therefore, in consideration of the premises and of the mutual
promises and covenants contained herein, the parties hereto agree as follows:
I. DEFINITIONS
A. "Field of Use" shall mean the radio frequency (RF) cardiac ablation
therapy field.
B. "Spot Catheter Patents" shall mean U.S. Patent No. 5,462,521, "Fluid
Cooled and Perfused Tip For A Catheter" issued on October 31, 1995 and
U.S. Patent No. 5,643,197 (CIP), entitled "Fluid Cooled And Perfused
Tip For A Catheter" issued on July 1, 1997 and U.S. Patent Application
Serial No. 08/496,947 entitled "Fluid Cooled and Perfused Tip for a
Catheter" filed on June 30, 1995, and any application issuing from the
disclosure listed on Schedule 1, and all divisionals, continuations,
continuations-in-part, re-issues, re-examinations and corresponding
foreign patents thereof.
C. "Spot Catheter Product" shall mean any and all irrigated porous tip
RF ablation catheters covered by one or more claims of the Spot
Catheter Patents.
D. "Spot Catheter Technology" shall mean all information, data, and
know-how relating to the irrigated porous tip RF ablation catheter,
including without limitation, processes, techniques, methods,
protocols, products, apparatuses and other materials and compositions
which are reasonably related to irrigated porous tip RF ablation
catheters, but shall not include any information which, at the time of
disclosure, was published, known publicly, or otherwise in the public
domain; any information which, after disclosure, is published, becomes
known publicly, or otherwise becomes part of the public domain through
no fault of Xxxxxx Xxxxxxx; any information which, prior to the time of
disclosure, has been practiced by or is known to Xxxxxx Xxxxxxx as
evidenced by written documentation or other physical evidence or; any
information which, after disclosure, is made available to Xxxxxx
Xxxxxxx by a third party under no obligation of confidentiality.
E. "Linear Catheter Patents" shall mean U.S. Patent No. 5,800,428
entitled "Linear Catheter Ablation System" issued on September 1, 1998
and U.S. Patent Application Serial No. 09/073,651 entitled "Linear
Catheter Ablation System" filed on May 9, 1998, and any application
issuing from the disclosures listed on Schedule 2, and all divisionals,
continuations, continuations-in-part, re-issues, re-examinations and
corresponding foreign patents thereof.
F. "Linear Catheter Product" shall mean any and all irrigated linear
lesion RF ablation catheters covered by one or more claims of the
Linear Catheter Patents.
G. "Linear Catheter Technology" shall mean all information, data, and
know-how relating to the irrigated linear lesion RF ablation catheter
including without limitation, processes, techniques, methods,
protocols, products, apparatuses and other materials and compositions
which are reasonably related to irrigated linear lesion RF ablation
catheters, but shall not include any information which, at the time of
disclosure, was published, known publicly, or otherwise in the public
domain; any information which, after disclosure, is published, becomes
known publicly, or otherwise becomes part of the public domain through
no fault of Xxxxxx Xxxxxxx; any information which, prior to the time of
disclosure, has been practiced by or is known to Xxxxxx Xxxxxxx as
evidenced by written documentation or other physical evidence or; any
information
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which, after disclosure, is made available to Xxxxxx Xxxxxxx by a third
party under no obligation of confidentiality.
H. "Effective Date" shall mean the date above-written.
I. "Affiliated Company" shall mean any entity that directly or
indirectly controls, is controlled by or is under common control with
Xxxxxx Xxxxxxx, and for such purpose "control" shall mean the
possession, direct or indirect, of the power to direct or cause the
direction of the management and the policies of the entity, whether
through the ownership of voting securities, by contract or otherwise.
J. "Net Selling Price" shall mean the aggregate invoice price of a Spot
Catheter Product or Linear Catheter product to a third party that is
not Xxxxxx Xxxxxxx or an Affiliated Company, less discounts actually
allowed and taken, refunds, returns, allowances, the cost of
replacement or credit, sales commissions actually paid to third parties
that are not Affiliated Companies, separately invoiced postage,
separately invoiced insurance and other separately invoiced shipping
charges, and customs, duties and other governmental charges and import,
use and sales tax paid by Xxxxxx Xxxxxxx.
K. "Confidential Information" shall mean information provided by one
party or its Affiliated Companies to the other party or its Affiliated
Companies which if in written form is marked as being confidential and
if in oral form, is reduced to writing and a copy sent to the recipient
within thirty (30) days of disclosure. Such information may include,
without limitation, (a) matters of a technical nature such as trade
secret processes or devices, techniques, data, formulas, inventions
(whether or not patentable), specifications and characteristics of
products planned or being developed, and research subjects, methods and
results; (b) matters of a business nature such as information about
costs, margins, pricing policies, markets, sales, suppliers, customers,
product plans and marketing plans or strategies; and (c) other
information of a similar nature that is not generally known to the
public.
II. PURCHASE, SALE AND ASSIGNMENT; LICENSE.
A. Angeion hereby sells, assigns, conveys, transfers and delivers to
Xxxxxx Xxxxxxx, its successors and permitted assigns, and Xxxxxx
Xxxxxxx hereby purchases, acquires and accepts from Angeion the Spot
Catheter Patents and the Spot Catheter Technology and the Linear
Catheter Patents and the Linear Catheter Technology to be used only in
the Field of Use (except as expressly provided herein), subject to and
in accordance with the terms and conditions of this Agreement,
including the right to xxx for infringement. Angeion further agrees to
provide to Xxxxxx Xxxxxxx the documentation necessary to transfer the
Spot Catheter Technology and Linear Catheter Technology and to sign the
necessary assignment documents for the patents for recordation in the
United States Patent and Trademark Office and foreign patent offices.
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B. [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
C. [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
D. From and after the Effective Date, Xxxxxx Xxxxxxx shall pay a
royalty amount equal to 5% of the Net Selling Price of Spot Catheter
Products and Linear Catheter Products sold anywhere in the world by
Xxxxxx Xxxxxxx or any Affiliated Companies in the Field of Use. For
Spot Catheter Products or Linear Catheter Products which are neither
manufactured nor sold in a country where there is patent coverage under
either the Spot Catheter Patents or the Linear Catheter Patents, Xxxxxx
Xxxxxxx or any Affiliated Companies shall pay a royalty of only 2% of
the Net Selling Price of such product. Royalty payments shall continue
until the first to occur of the following: [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***]
E. Xxxxxx Xxxxxxx hereby grants back to Angeion a royalty-free,
irrevocable, exclusive (subject to the rights expressly reserved by
Xxxxxx Xxxxxxx hereunder, including without limitation those described
in Article X) license to Spot Catheter Patents and Linear Catheter
Patents in all fields except the Field of Use.
F. [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
G. [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
H. Each calendar quarter following the Effective Date, Xxxxxx Xxxxxxx
shall provide Angeion with a quarterly royalty report setting forth the
total Net Selling Price of Spot Catheter Products and Linear Catheter
Products by Xxxxxx Xxxxxxx and its Affiliated Companies for that
quarter, as well as any royalties received from third parties for that
quarter pursuant to Subsection I. The quarterly report and any payments
due to Angeion shall be made and delivered to Angeion no later than
thirty (30) days following the end of the calendar quarter. All
royalties shall be calculated in U.S. Dollars and shall be due and
payable to Licensor in U.S. Dollars. In the event that the net Selling
Price of Spot Catheter Products and Linear Catheter Products are made
at prices calculated in a currency other than U.S. Dollars, Xxxxxx
Xxxxxxx shall calculate royalties due for such sales based on Xxxxxxx &
Johnson's existing currency translation practices, or such currency
translation practices as are customary in this industry if Xxxxxxx &
Johnson's existing currency translation practices are not acceptable to
the independent accounting firm selected by Angeion in subsection I.
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I. Xxxxxx Xxxxxxx and its Affiliated Companies shall keep accurate
records reflecting the Net Selling Price of all Spot Catheter Products
and Linear Catheter Products. Angeion shall have the right to audit the
quarterly reports and to inspect such records of Xxxxxx Xxxxxxx and its
Affiliated Companies using an independent public accounting firm of
national reputation selected and paid for by Angeion no more than twice
a year during normal business hours and upon reasonable notice. In the
event that any such audit reveals a discrepancy of more than five
percent (5%) from the royalties due to Angeion, Xxxxxx Xxxxxxx shall
bear the costs of such audit. Any such independent accounting firm
shall execute such confidentiality undertakings as Xxxxxx Xxxxxxx may
reasonably require.
J. In the event that any payments due to Angeion (including royalties
or invoices) are delinquent, such delinquent payments shall bear
interest at [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. To the
extent that any such audit shows an overpayment, such overpayment shall
be shown as a credit on the next quarterly royalty report, or shall be
promptly refunded at the option of Xxxxxx Xxxxxxx.
III. DEVELOPMENT PROGRAM.
A. Angeion shall complete at no additional charge development of the
Spot Catheter Product in accordance with the specification as set forth
in Exhibit A for clinical studies to support a Pre-Market Approval
("PMA") submission. Any changes to the specification for the Spot
Catheter Product reasonably requested by Xxxxxx Xxxxxxx after the
Effective Date shall be completed by Angeion and paid for by Xxxxxx
Xxxxxxx on a time and materials basis at the Development Rates as set
forth in Exhibit B.
B. Angeion shall develop Linear Catheter Product concept prototypes in
accordance with a project plan to be agreed upon by the parties. Xxxxxx
Xxxxxxx shall select a Linear Catheter Product from the concept
prototypes and the parties shall agree upon a project plan and
specifications for the selected concept prototype of the Linear
Catheter Product. Development of the selected concept prototypes of the
Linear Catheter Product shall include design, building and testing of
prototypes and clinical units for PMA submission, equipment
modifications and in vitro testing, when required.
C. Xxxxxx Xxxxxxx will fund Angeion for reasonable costs incurred
commencing January 1, 1998 to produce the concept prototypes and
develop the selected concept prototype for the Linear Catheter Product
(including not more than [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]incurred as of the Effective Date as set forth in the
invoice attached as Exhibit C) in accordance with a budget of up to
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH
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THE SECURITIES AND EXCHANGE COMMISSION***] and a set of milestones to
be agreed by the parties as part of the project plan. Angeion shall use
its best efforts to complete development of the selected concept
prototype of the Linear Catheter Product in accordance with the budget
and milestones and shall not incur additional charges or costs above
the agreed upon budget without prior written approval of Xxxxxx
Xxxxxxx; however, the budget shall be based funding Angeion on a time
and materials basis at the Development Rates as set forth in Exhibit B.
Angeion does not guarantee or warrant that the development work related
to the selected concept prototype of the Linear Catheter Product can be
completed [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. All sums
paid pursuant to subparagraph C of this section will be paid upon
receipt of a statement of services performed. Angeion shall keep
accurate records reflecting the development work related to the Linear
Catheter Product. Xxxxxx Xxxxxxx shall have the right to audit the
invoices and to inspect such records of Angeion no more than twice a
year during normal business hours and upon reasonable notice.
D. Notwithstanding the provisions of paragraph III.C above, it is
understood that during the term of this Agreement Xxxxxx Xxxxxxx may
elect to bring within the Xxxxxx Xxxxxxx organization certain or all of
the development and manufacturing activities relating to the Linear
Catheter Product as set forth in paragraph III.C and to terminate such
activities by Angeion. Prior to such transfer of activities, Xxxxxx
Xxxxxxx shall give Angeion sixty (60) days written notice of its
intentions. In such a case, Xxxxxx Xxxxxxx shall be liable only for
charges for all work done or non-cancelable costs committed by Angeion
prior to such transfer. Angeion shall exercise diligent efforts to
minimize any such non-cancelable costs.
E. Project reviews will be conducted on a quarterly basis or more
frequently upon request by Xxxxxx Xxxxxxx commencing the month the
agreement is signed. The review will include access by Xxxxxx Xxxxxxx,
if desired, to all design documentation including the Design History
File. Angeion will provide detailed monthly status reports including
expenses. Angeion will not exceed a monthly expense total as agreed by
the parties without prior written approval of Xxxxxx Xxxxxxx.
F. Angeion shall provide overall project leadership to develop and
manufacture the Spot Catheter Product and Linear Catheter Product.
Product priorities for the Spot Catheter Product, and product
priorities, features and specifications for the Linear Catheter Product
initially will be decided by Xxxxxx Xxxxxxx, after discussions with
Angeion. Any changes to the project plan or specifications for the
Linear Catheter Products shall be agreed upon by both parties in
writing.
IV. CLINICAL SUPPLIES AND TECHNOLOGY TRANSFER.
A. Angeion will manufacture 250 Spot Catheter Products for Xxxxxx
Xxxxxxx for use in clinical trials and will xxxx Xxxxxx Xxxxxxx for
these units at a cost of
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[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***].
B. Upon completion of the manufacture of the clinical supplies for the
Spot Catheter Product, or at the request of Xxxxxx Xxxxxxx, Angeion
shall provide technology transfer and technical support for a period of
one (1) year to transfer to Xxxxxx Xxxxxxx the production and
manufacturing of the Spot Catheter Products on a time and materials
basis at the Development Rates set forth in Exhibit B.
C. Angeion will manufacture, upon request by Xxxxxx Xxxxxxx, Linear
Catheter Products for Xxxxxx Xxxxxxx for use in clinical trials at an
agreed upon price per unit based upon the specifications for the Linear
Catheter Product and as of the milestone for the completion of the
project. Any changes to the specification for the Linear Catheter
Product reasonably requested by Xxxxxx Xxxxxxx after the milestone date
for completion of the specification shall be completed by Angeion and
paid for by Xxxxxx Xxxxxxx on a time and materials basis at the
Development Rates set forth in Exhibit B.
D. Upon completion of the manufacture of the clinical supplies of the
Linear Catheter Product, or at the request of Xxxxxx Xxxxxxx pursuant
to subparagraph E, Angeion shall provide technology transfer and
technical support for a period of up to one (1) year to transfer to
Xxxxxx Xxxxxxx the production and manufacturing of the Linear Catheter
Products on a time and materials basis at the Development Rates set
forth in Exhibit B.
E. [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
V. CLINICAL STUDIES AND REGULATORY FINDINGS.
A. If Xxxxxx Xxxxxxx determines in its sole discretion that it desires
to conduct clinical studies for the Spot Catheter Product and Linear
Catheter Product, Xxxxxx Xxxxxxx shall organize, sponsor and support
all future clinical trials.
B. Angeion has previously obtained Investigational Device Exemption
("IDE") approval for the Spot Catheter. The parties shall coordinate
the transition of the existing clinical IDE submission for the Spot
Catheter to Xxxxxx Xxxxxxx.
C. If and as required under the United States laws and FDA
regulations[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***], at its
expense, shall exercise reasonable diligence to obtain and maintain all
registrations, licenses and permits required to comply with all laws
and regulations for sale and distribution of the Spot Catheter and
Linear Catheter.
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D. [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***].
E. Angeion shall have access to clinical sites and clinical information
as may be reasonably required to facilitate Angeion's development
responsibilities.
F. Xxxxxx Xxxxxxx shall have the opportunity at its option to access
clinical and regulatory expertise of Angeion in connection with the
Spot Catheter Products and Linear Catheter Products at the Development
Rates as set forth in Exhibit B.
G. Angeion shall, to the best of its ability, ensure that the
identified clinical investigators for the [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***].
H. Angeion shall comply with all applicable provisions of the FDA
Quality System Regulation (QSR) and FDA Good Clinical Practices (GCP)
Regulation. Angeion shall notify Xxxxxx Xxxxxxx of any planned or
ongoing regulatory inspections of its facilities and operations.
VI. MARKETING.
All Spot Catheter Product and Linear Catheter Product in the Field of
Use shall be marketed under the name of Xxxxxx Xxxxxxx or such other
name or names as Xxxxxx Xxxxxxx may choose.
VII. TERM.
A. This Agreement shall remain in effect from the Effective Date
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***].
B. Either party may terminate this Agreement in the event such other
party shall have materially breached or defaulted in the performance of
any of its obligations hereunder, and such default shall have continued
for thirty (30) days after written notice thereof was provided to the
breaching party by the non-breaching party. Any termination shall
become effective at the end of the thirty (30) day period unless the
breaching party has cured any such breach or default prior to the
expiration of the thirty (30) day period.
C. Termination of this Agreement shall not release any party hereto
from any liability which, at the time of termination, has already
accrued to the other party or which is attributable to a period prior
to such termination, nor preclude either party from pursuing any rights
and remedies it may have hereunder at law or in equity which accrued or
are based upon any event occurring prior to such termination.
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VIII. NON-COMPETE.
During the Term and for a period of [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***], Angeion shall not manufacture, sell or develop
for third parties catheters for use in the Field of Use.
IX. CONFIDENTIALITY.
A. Unless otherwise expressly provided for in this Agreement, both
parties shall treat the Confidential Information received from the
other party as proprietary or confidential and shall not disclose any
such Confidential Information to any third party during the Term and
for a period of five (5) years thereafter, except for information
which:
(i) at the time of disclosure, was published, known
publicly or otherwise in the public domain;
(ii) after disclosure, is published, becomes known
publicly or otherwise becomes part of the public
domain through no fault of the receiving party;
(iii) prior to the time of disclosure, is known to the
receiving party as evidenced by its written records
and is not then subject to an obligation of
confidentiality to any third party; and
(iv) after disclosure, is made available to the receiving
party in good faith by a third party under no
obligation of confidentiality and without restriction
on its further disclosure by the receiving party.
B. Notwithstanding the above, either party may disclose Confidential
Information of the other and this Agreement to their legal
representatives and employees to the extent such disclosure is
reasonably necessary to achieve the purposes of this Agreement; or in
connection with the filing and support of patent applications; or as
required by law or to comply with applicable governmental regulations
or court order, including the FDA and its foreign counterparts;
provided that if a party is required to make such disclosure of another
party's Confidential Information, other than pursuant to a
confidentiality agreement, it will give reasonable advance notice to
the other party of such disclosure and, save to the extent
inappropriate in the case of patent applications, will use its
reasonable best efforts to secure confidential treatment of such
information in consultation with the other party prior to its
disclosure and disclose only the minimum necessary to comply with such
requirements.
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X. LICENSE OPTIONS.
A. Angeion hereby grants to Xxxxxx Xxxxxxx and its Affiliated Companies
an option to practice the inventions of the Spot Catheter Patents and
practice the Spot Catheter Technology and practice the inventions of
the Linear Catheter Patents and practice the Linear Catheter Technology
limited to the additional field of [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***].
B. Upon exercise of the Option to obtain these rights in the TMR Field,
Xxxxxx Xxxxxxx or its Affiliated Companies shall:
(i) [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]
(ii) [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***].
C. Angeion grants to Xxxxxx Xxxxxxx and its Affiliated Companies an
option to practice the inventions of the Spot Catheter Patents and
practice the Spot Catheter Technology and practice the inventions of
the Linear Catheter Patents and practice the Linear Catheter Technology
in all fields outside the Field of Use and [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] ("OTHER PRODUCTS FIELD").
D. Upon exercise of the Option to obtain the Other Products Field,
Xxxxxx Xxxxxxx or its Affiliates Companies shall:
(i) [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***]
(ii) [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***].
E. Royalty payments made in accordance with this Section shall continue
until the first to occur of the following: [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***].
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XI. RIGHT OF FIRST NEGOTIATION.
Subject to any contractual obligations between Angeion and ELA Medical,
Angeion agrees to grant Xxxxxx Xxxxxxx a right of first negotiation to
obtain all rights in any new concepts or inventions in the Field of Use
developed by Angeion to the extent not already covered under this
Agreement.
XII. INTELLECTUAL PROPERTY DEVELOPED UNDER THIS AGREEMENT.
A. All patentable and unpatentable inventions and other intellectual
property conceived or reduced to practice solely by employees or
consultants of Angeion as a result of the development work conducted
under this Agreement in the Field of Use ("Angeion Inventions") shall
be the property of Xxxxxx Xxxxxxx.
B. All patentable and unpatentable inventions and other intellectual
property conceived or reduced to practice jointly by employees or
consultants of Xxxxxx Xxxxxxx and Angeion as a result of the
development work conducted under this Agreement in the Field of Use
("Joint Inventions") shall be the property of Xxxxxx Xxxxxxx.
C. Angeion agrees to assign to Xxxxxx Xxxxxxx all rights in any such
Angeion Inventions or Joint Inventions. Upon the request of Xxxxxx
Xxxxxxx and at Xxxxxx Xxxxxxx'x expense, Angeion will assist Xxxxxx
Xxxxxxx, or its designee, in making application for Letters Patent in
any country in the world. Angeion further agrees to have executed all
papers and do all things which may be necessary or advisable to
prosecute such applications and to transfer to and vest in Xxxxxx
Xxxxxxx all the right, title and interest in and to such invention,
discoveries or ideas and all applications for patents and Letters
Patent issued hereon.
D. Xxxxxx Xxxxxxx shall be responsible for [THE COST OF FILING AND
MAINTAINING ALL OF THE SPOT CATHETER PATENTS AND LINEAR CATHETER
PATENTS DURING THE TERM, PROVIDED XXXXXX XXXXXXX SHALL NOT BE OBLIGATED
TO SPEND MORE THAN A MAXIMUM COST OF [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] FOR A SINGLE U.S. PATENT APPLICATION AND A
TOTAL OF [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] FOR FILING
CORRESPONDING FOREIGN PATENT APPLICATIONS CORRESPONDING TO A SINGLE
U.S. PATENT APPLICATION.]
E. In the event Xxxxxx Xxxxxxx elects not to file or maintain a patent
application in a given country, Angeion shall be free to file or
maintain such patent applications in that country.
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XIII. WARRANTIES AND REPRESENTATIONS.
A. Xxxxxx Xxxxxxx and Angeion, each represent and warrant to the other
that:
(i) it has the power to execute, deliver and perform the
terms and conditions of this Agreement and has taken
all necessary action to authorize the execution,
delivery and performance thereof;
(ii) the execution, delivery or performance of this
Agreement will not constitute a violation of, be in
conflict with, or result in, a breach of any
agreement or contract to which it is a party or to
which it is bound;
(iii) this Agreement constitutes the legal, valid and
binding agreement enforceable in accordance with its
terms, except as enforcement of remedies may be
limited by general principles of bankruptcy,
insolvency, or other similar laws affecting
creditors' rights generally; and
(iv) it will comply with all applicable laws, regulations,
ordinances, statutes, decrees or proclamations of all
governmental authorities having jurisdiction over
this Agreement.
B. In addition, Angeion warrants to Xxxxxx Xxxxxxx that it:
(i) is the owner of all right, title and interest in and
to the Spot Catheter Patents and Spot Catheter
Technology other than the interest in third party
income with respect to the Spot Catheter Patents as
evidenced by the Assignment Agreement attached hereto
as Exhibit D;
(ii) is the owner of all right, title and interest in and
to the Linear Catheter Patents and Linear Catheter
Technology;
(iii) has not licensed the Spot Catheter Patents, Spot
Catheter Technology, Linear Catheter Patents or
Linear Catheter Technology to any third party.
XIV. INFRINGEMENT.
Xxxxxx Xxxxxxx shall have the right, but not the obligation, to bring
suit against a third party for infringement of the Spot Catheter and
Linear Catheter Patents, however, if Xxxxxx Xxxxxxx has not brought any
such suit after three (3) months' notice having been given to Angeion,
Angeion may bring such suit and may join Xxxxxx Xxxxxxx in such suit if
necessary. The party initiating such suit shall be responsible for all
costs of such suit and shall receive all recovery in such suit.
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XV. INDEMNIFICATION.
A. Angeion shall indemnify, defend and hold harmless Xxxxxx Xxxxxxx and
its directors, officers and employees ("Xxxxxx Xxxxxxx Indemnitees")
from and against any and all liabilities, damages, losses, costs or
expenses, including reasonable attorneys' fees, resulting from any
claim, suit or proceeding brought by a third party for infringement of
third party patents by Spot Catheter Products or Linear Catheter
Products manufactured by Angeion.
B. Xxxxxx Xxxxxxx shall indemnify, defend and hold harmless Angeion and
its directors, officers and employees ("Angeion Indemnitees") from and
against any and all liabilities, damages, losses, costs or expenses,
including reasonable attorneys' fees, resulting from any claim, suit or
proceeding brought by a third party for physical injury arising out of
or in connection with the use of Spot Catheter Products and the Linear
Catheter Products; except for Spot Catheter Products and Linear
Catheter Products manufactured by Angeion to the extent such injury is
caused by the negligence or willful misconduct of Angeion.
C. Beginning at the time that the Spot Catheter Product or Linear
Catheter Product is being commercially distributed or sold (other than
for the purpose of obtaining regulatory approvals), Xxxxxx Xxxxxxx or
its Affiliated Companies shall, at its sole cost and expense, procure
and maintain commercial general liability insurance in amounts not less
than $2,000,000 per incident and $2,000,000 annual aggregate. Such
commercial general liability insurance shall provide (i) liability
coverage and (ii) contractual liability coverage for indemnification
under subsection A hereof. If Xxxxxx Xxxxxxx and its Affiliated
Companies may elect to self-insure all or part of the limits described
above (including deductibles or retentions which are in excess of
$250,000 annual aggregate) on the same basis that it insures other
similar risks. The minimum amount of insurance coverage required under
this subsection B shall not be construed to create a limit of Xxxxxx
Xxxxxxx'x liability with respect to indemnification under subsection A
hereof. Xxxxxx Xxxxxxx shall provide written evidence of such insurance
upon request by Angeion and shall provide Angeion with written notice
at least fifteen (15) days prior to the cancellation, non-renewal or
material change in such insurance.
XVI. MISCELLANEOUS.
A. Press Releases. Neither party will generate any press releases or
otherwise disclose publicly the existence or terms of this Agreement
other than the initial press release to be issued upon the execution of
this Agreement which is attached hereto as Exhibit E, without the prior
written consent of the other party, except as may be otherwise required
by law or as necessary for Angeion to satisfy the contractual
obligations between Angeion and ELA Medical. Xxxxxx Xxxxxxx
acknowledges that Angeion believes that this Agreement is likely to be
deemed a material agreement for Angeion, thereby requiring Angeion to
make an SEC filing of this Agreement. In the
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event of such a required filing, Angeion agrees to request confidential
treatment of sensitive portions of this Agreement and to work with
Xxxxxx Xxxxxxx in that regard.
B. Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California.
C. Assignment. Neither party may assign this Agreement without the
prior written consent of the other, which consent shall not be
unreasonably withheld; provided, however, Xxxxxx Xxxxxxx may assign
this Agreement to an Affiliated Company but nothing herein shall
prevent Angeion from assigning to a third party without the consent of
Xxxxxx Xxxxxxx any royalty payments or other rights to be received by
Angeion under the provisions of Article II (D), (E), and (G), IV (E)
and X (B), (D) and (E).
D. Independent Contractor. The relationship of Xxxxxx Xxxxxxx and
Angeion is that of an independent contractor and nothing contained in
this Agreement shall be construed to give either party the power to
direct and control the activities of the other or create or assume any
obligation on behalf of the other for any purpose whatsoever.
E. Entire Agreement. This Agreement constitutes the entire Agreement
between the parties hereto concerning the subject matter hereof and any
representation, promise or condition in connection therewith, not
incorporated herein, shall not be binding upon either party. Before
signing this Agreement the parties have had numerous conversations,
including preliminary discussions, formal negotiations and informal
conversations at meals and social occasions, and have generated
correspondence and other writings, in which the parties discussed the
transaction which is the subject of this Agreement and their
aspirations for success. In such conversations and writings,
individuals representing the parties may have expressed their judgments
and beliefs concerning the intentions, capabilities, and practices of
the parties, and may have forecasted future events. The parties
recognize that such conversations and writings often involve an effort
by both sides to be positive and optimistic about the prospects for the
transaction. However, it is also recognized, that all business
transactions contain an element of risk, as does the transaction
contemplated by this Agreement, and that it is normal business practice
to limit the legal obligations of contracting parties to only those
promises and representations which are essential to their transaction
so as to provide certainty as to their respective future rights and
remedies. Accordingly, this Agreement is intended to define the full
extent of the legally enforceable undertakings of the parties hereto,
and no promise or representation, written or oral, which is not set
forth explicitly in this Agreement is intended by either party to be
legally binding. Both parties acknowledge that in deciding to enter
into this Agreement and to consummate the transaction contemplated
hereby neither has relied upon any statements or representations,
written or oral, other than those explicitly set forth therein.
F. Amendment. No changes, amendments or alterations shall be effective
unless in writing and signed by all parties.
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G. Waiver. No waiver of any default in the performance of any of the
duties or obligations arising out of this Agreement shall be valid
unless in writing and signed by the waiving party.
H. Severability. If any provision of this Agreement shall be held to be
unenforceable in whole or in part, then the invalidity of such
provision shall not be held to invalidate any other provision herein,
and all other provisions shall remain in full force and effect.
I. Dispute Resolution.
a. Any dispute, claim, or controversy arising from or
related in any way to this Agreement or the
interpretation, application, breach, termination or
validity thereof, including any claim of inducement
of this Agreement by fraud or otherwise, will be
submitted for resolution to arbitration pursuant to
the commercial arbitration rules then pertaining of
the Center For Public Resources ("CPR"), except where
those rules conflict with these provisions, in which
case these provisions control. The arbitration will
be held in California.
b. The panel shall consist of three arbitrators chosen
from the CPR Panels of Distinguished Neutrals, each
of whom is a lawyer specializing in business
litigation with at least 15 years experience with a
law firm of over 25 lawyers or was a judge of a court
of general jurisdiction. In the event the aggregate
damages sought by the claimant are stated to be less
than $5 million, and the aggregate damages sought by
the counterclaimant are stated to be less than $5
million, and neither side seeks equitable relief,
then a single arbitrator shall be chosen, having the
same qualifications and experience specified above.
c. The parties agree to cooperate (1) to obtain
election of the arbitrator(s) within 30 days of
initiation of the arbitration; (2) to meet with the
arbitrator(s) within 30 days of selection; and (3)
to agree at that meeting or before upon procedures
for discovery and as to the conduct of the hearing
which will result in the hearing being concluded
within no more than 9 months after selection of the
arbitrator(s) and in the award being rendered within
60 days of the conclusion of the hearings, or of any
post-hearing briefing, which briefing will be
completed by both sides within 20 days after the
conclusion of the hearings. In the event no such
agreement is reached, the CPR will select
arbitrator(s), allowing appropriate strikes for
reasons of conflict or other cause and three
preemptory challenges for each side. The
arbitrator(s) shall set a date for the hearing,
commit to the rendering of the award within 60 days
of the conclusion of the evidence at the hearing, or
of any post-hearing briefing (which briefing will be
completed by both sides in no more than 20 days after
the conclusion of the hearings), and provide for
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discovery according to these time limits, giving
recognition to the understanding of the parties
hereto that they contemplate reasonable discovery,
including document demands and depositions, but that
such discovery be limited so that the time limits
specified herein may be met without undue difficulty.
In no event will the arbitrator(s) allow either side
to obtain more than a total of 40 hours of deposition
testimony from all witnesses including both fact and
expert witnesses. In the event multiple hearing days
are required, they will be scheduled consecutively to
the greatest extent possible.
d. The arbitrator(s) shall render their award following
the substantive law of California. The arbitrator(s)
shall render an opinion setting forth findings of
fact and conclusions of law with the reasons therefor
stated. A transcript of the evidence adduced at the
hearing shall be made and shall, upon request, be
made available to either party.
e. To the extent possible, the arbitration hearings and
award will be maintained in confidence.
f. The United States District Court for the District of
California may enter judgment upon any award. In the
event the panel's award exceeds $5 million in
monetary damages or includes or consists of equitable
relief, then the court shall vacate, modify or
correct any award where the arbitrators' findings of
fact are clearly erroneous, and/or where the
arbitrators' conclusions of law are erroneous; in
other words, it will undertake the same review as if
it were a federal appellate court reviewing a
district court's findings of fact and conclusions of
law rendered after a bench trial. An award for less
than $5 million in damages and not including
equitable relief may be vacated, modified or
corrected only upon the grounds specified in the
Federal Arbitration Act. The parties consent to the
jurisdiction of the above-specified Court for the
enforcement of these provisions, the entry of
judgment on any award and the vacatur, modification
and correction of any award as above specified. In
the event such Court lacks jurisdiction, then any
court having jurisdiction of this matter may enter
judgment upon any award and provide the same relief,
and undertake the same review, as specified herein.
g. Each party has the right before or during the
arbitration to seek and obtain from the appropriate
court provisional remedies such as attachment,
preliminary injunction, replevin, etc. to avoid
irreparable harm, maintain the status quo or preserve
the subject matter of the arbitration.
h. EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY
ISSUE BY JURY.
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i. EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE OR
EXEMPLARY DAMAGES FROM THE OTHER.
j. EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL
DAMAGES FROM THE OTHER UNLESS (1) THE FORESEEABILITY
OF SUCH DAMAGES AT THE TIME OF THE CONTRACT AND (2)
THE AMOUNT OF SUCH DAMAGES ARE PROVEN BY CLEAR AND
CONVINCING EVIDENCE.
J. Mediation.
a. Any dispute, controversy or claim arising out of or
related to this Agreement, or the interpretation,
application, breach, termination or validity thereof,
including any claim of inducement by fraud or
otherwise, which claim would, but for this provision,
be submitted to arbitration shall, before submission
to arbitration, first be mediated through non-binding
mediation in accordance with the Model Procedures for
the Mediation of Business Disputes promulgated by the
CPR then in effect except where those rules conflict
with these provisions, in which case these provisions
control. The mediation shall be conducted in
California and shall be attended by a senior
executive with authority to resolve the dispute from
each of the operating companies that are parties.
b. The mediator shall be an attorney specializing in
business litigation who has at least 15 years of
experience as a lawyer with a law firm of over 25
lawyers or was a judge of a court of general
jurisdiction and who shall be appointed from the list
of neutrals maintained by CPR.
c. The parties shall promptly confer in an effort to
select a mediator by mutual agreement. In the absence
of such an agreement, the mediator shall be selected
from a list generated by CPR with each party having
the right to exercise challenges for cause and two
peremptory challenges within 72 hours of receiving
the CPR list.
d. The mediator shall confer with the parties to design
procedures to conclude the mediation within no more
than 45 days after initiation. Under no circumstances
shall the commencement of arbitration under paragraph
I of this Section above be delayed more than 45 days
by the mediation process specified herein.
e. Each party agrees to toll all applicable statutes of
limitation during the mediation process and not to
use the period of pendency of the mediation to
disadvantage the other party procedurally or
otherwise. No statements made by either side during
the mediation may be used by the other during any
subsequent arbitration.
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f. Each party has the right to pursue provisional relief
from any court, such as attachment, preliminary
injunction, replevin, etc., to avoid irreparable
harm, maintain the status quo, or preserve the
subject matter of the arbitration, even though
mediation has not been commenced or completed.
K. Notices. Any required notices hereunder shall be given in writing by
certified mail or overnight express deliver at the address of each
party below, or to such other address as either party may indicate on
its behalf by written notice:
If to Xxxxxx Xxxxxxx: Xxxxxx Xxxxxxx, Inc.
0000 Xxxxxxxxxx Xxxxxx
Xxxxxxx Xxxx, XX 00000
Attention: President
If to Angeion: Angeion Corporation
0000 Xxxxxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000
Attention: President
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
representatives, have caused this Agreement to be executed affixing their
signatures below.
XXXXXX XXXXXXX, INC.
By /s/ Xxxxxx X. Xxxx
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Title V.P. Business Development
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ANGEION CORPORATION
By /s/Xxxxx X. Xxxxxx
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Title President and CEO
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