1
EXHIBIT 10.21
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "Agreement") is effective as of
this 6th day of February, 1997 (the "Effective Date"), by and between
Endosonics Corporation, a corporation organized and existing under the laws of
the State of Delaware and having a principal place of business at 0000 Xxxxxxx
Xxxx, Xxxxxx Xxxxxxx, Xxxxxxxxxx 00000 ("Endosonics") and Cardiovascular
Dynamics, Inc., a corporation organized and existing under the laws of the
State of Delaware and having a principal place of business at 00000 Xxxxx
Xxxxxxx, Xxxxx 000, Xxxxxx, Xxxxxxxxxx 00000 ("CVD").
WHEREAS, CVD is the owner of the entire right, title and
interest in and to the Licensed Patents set forth in Exhibit A;
WHEREAS, CVD has developed various catheter products using
proprietary technology covered by the Licensed Patents;
WHEREAS, ENDOSONICS is desirous of acquiring a non-exclusive
license to the Licensed Materials (as defined below) which shall include a
limited exclusive license to make, have made, use, sell and have sold catheter
products developed by Endosonics using the Licensed Materials;
WHEREAS, CVD is desirous of acquiring a non-exclusive license
to use Endosonics PMA Number P910031 (the "Endosonics PMA"), to reference, use
and rely upon information in the Endosonics PMA in order to enable CVD to file
for and obtain PMA approval for the Focus Catheters from the U.S. Food and Drug
Administration ("FDA"); and
WHEREAS, the parties are willing to grant such licenses upon
the terms and subject to the conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the foregoing and other
mutual covenants, terms and conditions hereinafter expressed, the receipt and
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:
2
ARTICLE I
DEFINITIONS
1.1 "LICENSED PATENTS" shall mean the patents set forth
in Exhibit A attached hereto and incorporated herein by this reference, and any
and all divisions, continuations-in-part, reissues, renewals, or extensions
thereof.
1.2 "FOCUS CATHETERS" shall mean all catheter products
combining CVD Focus Technology on the same catheter with an Endosonics
transducer developed by Endosonics pursuant to this Agreement using the
Licensed Patents and/or CVD Focus Technology.
1.3 "CVD FOCUS TECHNOLOGY" shall mean all CVD inventions
(whether or not patentable), ideas, know-how, trade secrets, processes and
other technical information necessary or useful in manufacturing the Focus
Catheters (including without limitation the Specifications (as defined below))
that CVD (i) owns or controls as of the Effective Date or (ii) acquires or
develops during the term of this Agreement.
1.4 "LICENSED MATERIALS" shall mean the Licensed Patents
associated with CVD Focus Technology.
1.5 "ENDOSONICS TRANSDUCER" shall mean the Endosonics
ultrasound transducer product(s) set forth in Exhibit B attached hereto and
incorporated herein by this reference.
1.6 "SPECIFICATIONS" shall mean the specifications for
Focus Catheter products developed by CVD using or incorporating the Licensed
Materials.
ARTICLE II
LICENSE XXXXX
XX.1 Subject to the terms and conditions of this
Agreement, CVD hereby grants to Endosonics (i) a non-exclusive, worldwide,
fully paid-up, royalty-free right and license to practice under the Licensed
Patents and to use the CVD Focus Technology to make, have made and use the
Focus Catheters, (ii) an exclusive, worldwide, fully paid-up, royalty-free
right and license to market, sell or otherwise distribute the Focus Catheters
only as bundled on the same catheter device with an Endosonics Transducer.
Upon execution of this Agreement, CVD shall transfer a copy of all existing
Licensed Materials to Endosonics.
2.
3
II.2 Subject to the terms and conditions of this
Agreement, Endosonics hereby grants to CVD a non-exclusive, worldwide, fully
paid-up, royalty-free right and license to reference, use, and rely upon
information in the Endosonics PMA in order to enable CVD to file for and obtain
PMA approval, as evidenced by a separate CVD PMA number on file at the FDA, for
the coronary balloon dilatation catheters and from the FDA. CVD shall use,
reference, or rely upon the Endosonics PMA for the limited purpose of obtaining
FDA approval of a unique PMA which will be in CVD's name and shall not be a PMA
supplement to Endosonics' PMA.
II.3 Subject to the terms and conditions of this
Agreement, Endosonics shall furnish to CVD a complete copy of all manufacturing
information in the Endosonics PMA applicable to CVD's manufacture of CVD
coronary balloon dilatation products.
II.4 Subject to the provisions of this Agreement,
Endosonics is authorized to improve, modify, correct and enhance the Licensed
Materials as it may deem appropriate, and Endosonics shall exclusively control,
and own all right, title and interest in and to, the resulting improvement,
modification, correction or enhancement including, without limitation, any
patent rights available with respect thereto, any trade secrets pertaining
thereto and any copyrights subsisting therein as derivative works, but only to
the extent that the same shall be separate and clearly distinguishable from the
underlying work. Nothing in this Section 2.4 is intended to modify Endosonics'
limited rights to market, sell or otherwise distribute Focus Catheters only as
bundled on the same catheter with an Endosonics Transducer, as defined in
Section 2.1 of this Agreement.
ARTICLE III
REPORTS AND EXPENSE REIMBURSEMENT
III.1 Should Endosonics incur any out-of-pocket expenses
to assist CVD in executing Sections 2.2 or 2.3 of this Agreement, CVD shall
reimburse Endosonics for such out-of-pocket expenses up to a maximum of One
Thousand Dollars ($1,000.00). If such out-of-pocket expenses exceed One
Thousand Dollars ($1,000.00), Endosonics shall request CVD's prior written
approval prior to incurring such expenses.
III.2 Should CVD incur any out-of-pocket expenses to
assist Endosonics in executing Section 2.1 of this Agreement, Endosonics shall
reimburse CVD for such out-of-pocket expenses up to a maximum of One Thousand
Dollars ($1,000.00). If such expenses exceed One Thousand Dollars ($1,000.00),
CVD shall request Endosonics' prior written approval prior to incurring such
expenses.
3.
4
ARTICLE IV
OWNERSHIP
IV.1 CVD Rights. As between the parties and subject to
the rights granted to Endosonics under this Agreement, all right, title and
interest in and to the Licensed Materials (including, without limitation, all
patent rights, copyrights, trade secret rights and other proprietary rights) is
and shall remain in CVD.
IV.2 Endosonics' Rights to Endosonics' PMA. Subject to
the rights granted to CVD under Section 2.2 of this Agreement, all right, title
and interest in and to the information contained in the Endosonics PMA
(including, without limitation, all patent rights, copyrights, trade secret
rights and other proprietary rights) shall remain in Endosonics.
ARTICLE V
PATENT AND REGULATORY MATTERS
V.1 Patent Enforcement. During the term of this
Agreement, CVD shall diligently maintain, protect and enforce the Licensed
Patents, which shall include taking all necessary action to prevent and
terminate any third party infringement of the Licensed Patents. CVD shall have
no responsibility to maintain, protect and enforce any technology or patents
resulting from any modifications to the Licensed Materials.
V.2 Domestic Regulatory Matters; CVD PMA Submission.
Endosonics shall cooperate fully with CVD in preparing regulatory filings
associated with CVD's submission of a PMA for all current Focus Catheter
products and shall prepare and execute promptly all documents or instruments
necessary to enable CVD to make such regulatory filings and to obtain FDA
approval of the PMA, including, without limitation:
(a) a signed, written statement from Endosonics to the
FDA that authorizes CVD and the FDA to reference, use, and reply upon the
Endosonics PMA in seeking approval for a PMA for CVD's Focus Catheter products;
and
(b) a statement signed by both CVD and Endosonics
confirming that Endosonics has furnished CVD with a complete copy of all
manufacturing information in the Endosonics PMA applicable to CVD's manufacture
of the Focus Catheter products.
V.3 Domestic Regulatory Matters; Annual Reporting
Requirements. CVD shall cooperate fully with Endosonics in preparing
regulatory filings associated with Endosonics submission of PMA reports
required by the FDA, including but not limited to
4.
5
Annual Reports. CVD shall disclose to Endosonics all changes to any product
distributed under the Endosonics PMA, whether considered significant or not,
and whether undertaken before or after initial product introduction, no later
than August 15 of each calendar year. CVD's obligations under this Section
shall terminate upon abandonment of Endosonics' PMA approvals for CVD
distributed products. A final report of all changes as described above shall
be submitted to Endosonics fifteen (15) days following such abandonment.
V.4 Domestic Regulatory Matters; Distribution of CVD
Product under Endosonics' PMA. CVD will cease to distribute CVD Focus products
which were approved under Endosonics' PMA following approval by the FDA of
CVD's original PMA Application, or twelve (12) months after execution of this
Agreement, whichever occurs first. No new applications shall be made under
Endosonics' PMA following execution of this Agreement.
V.5 Foreign Regulatory Matters. Endosonics shall obtain
and maintain all applicable approvals and registrations for the Catheters in
any country into which Endosonics shall distribute the Focus Catheters and CVD
shall render all necessary assistance to enable Endosonics to accomplish the
foregoing.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES OF CVD
VI.1 Title. CVD represents and warrants that, to the best
of its knowledge, it has complete title to the Licensed Materials, free from
any liens or encumbrances, and that, to the best of its knowledge, the use of,
or practice under, the Licensed Materials in the United States and its
territories will not infringe the intellectual property rights of any third
party.
VI.2 Validity. CVD represents and warrants that, to the
best of its knowledge, the Licensed Patents are valid and enforceable and that,
to the best of its knowledge, there are no third party infringers of the
Licensed Materials.
ARTICLE VII
CONFIDENTIALITY
Each party agrees that all inventions, processes, materials,
chemicals, reagents, know-how and ideas and all other business, technical and
financial information it obtains from the other are the confidential property
of the disclosing party ("Proprietary Information" of the disclosing party).
Except as expressly allowed in this Agreement, the receiving party will hold in
confidence and not use or disclose any Proprietary Information of the
disclosing party and
5.
6
shall similarly bind its employees in writing. The receiving party shall not
be obligated under this Article VII with respect to information that:
(i) is or has become readily publicly available
through no fault of the receiving party or its employees or agents; or
(ii) is received from a third party lawfully in
possession of such information and lawfully empowered to disclose such
information and provided the receiving party abides by all restrictions imposed
by such third party; or
(iii) was rightfully in the possession of the
receiving party prior to its disclosure by the other party provided the
receiving party abides by all restrictions imposed on its possession of such
information; or
(iv) was independently developed by employees or
consultants of the receiving party without access to such Proprietary
Information; or
(v) is required by order of a government agency
or court of competent jurisdiction to be disclosed.
ARTICLE VIII
INDEMNIFICATION
CVD agrees to indemnify Endosonics from, for, and against any
loss, cost, damages, liability or expense (including reasonable attorney's
fees) arising out of any claim ("Claim") brought by third parties (i) alleging
that the manufacture, use or sale of a Focus Catheter infringes any third party
rights or (ii) relating to any breach of the warranties set forth in Article VI
above (collectively, "Damages"); provided, however, that CVD's indemnification
obligations hereunder shall not apply to the extent (and only to the extent)
that such Damages result from (i) Endosonics's use or distribution of
technology and materials other than the Licensed Materials or (ii)
modifications, improvements, corrections or enhancements made by Endosonics to
the Licensed Materials. Endosonics agrees to indemnify CVD from, for, and
against Damages incurred by CVD that are excluded from CVD's indemnification
obligations pursuant to the foregoing sentence. In the event of a Claim, the
party seeking indemnification hereunder shall promptly notify the indemnifying
party of such Claim, shall allow the indemnifying party to have sole defense of
such Claim and shall cooperate and render reasonable assistance upon the
request, and at the expense, of the indemnifying party.
6.
7
ARTICLE IX
DISCLAIMERS AND LIMITATION OF LIABILITY
IX.1 EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTIES WITH RESPECT TO THE TECHNOLOGY OR
MATERIALS THAT IT PROVIDES TO THE OTHER PARTY UNDER THIS AGREEMENT AND EACH
PARTY HEREBY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ALL WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
IX.2 NEITHER PARTY WILL BE LIABLE TO THE OTHER (I) WITH
RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE,
STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INCIDENTAL
OR CONSEQUENTIAL DAMAGES OR (II) FOR LOST PROFITS OR DATA.
ARTICLE X
TERM AND TERMINATION
X.1 This Agreement shall commence as of the Effective
Date, and shall continue in force (unless terminated earlier in accordance with
this Article X) until the last of the Licensed Patents expires and any PMA or
regulatory approvals obtained through the use of Endosonics' PMA are abandoned,
or the last of the Licensed Patents is ruled invalid or unenforceable in a
final decision by a court of competent jurisdiction or by the United States
Patent and Trademark Office.
X.2 This Agreement and all licenses granted hereunder may
be terminated by either party immediately if the other party breaches a
material term or provision of this Agreement and fails to cure such breach
within sixty (60) days after written notice from the non- breaching party.
X.3 This Agreement also may be terminated by either
party, at its option, upon written notice to the other party, (i) upon the
institution by the other party of insolvency, receivership or bankruptcy
proceedings or any similar proceedings for the settlement of its debts, or (ii)
upon the institution of such proceedings against the other party, which are not
dismissed or otherwise resolved in such party's favor within sixty (60) days
thereafter.
7.
8
X.4 The following Articles shall survive termination of
this Agreement: I, IV, VI, VII, VIII, IX and XI, along with this Section 10.4.
Except in the case of termination by CVD pursuant to Section 10.2 above, the
licenses granted to Endosonics under Section 2.1 of this Agreement shall also
survive termination of this Agreement. In the event this Agreement is
terminated by CVD pursuant to Section 10.2 above, Endosonics shall have the
right thereafter to sell completed Focus Catheters then on hand, in the process
of being manufactured or as otherwise needed to meet its then-existing supply
obligations. Except in the case of termination by Endosonics pursuant to
Section 10.2 above, the licenses granted to CVD under Sections 2.2 of this
Agreement shall also survive termination of this Agreement. In the event this
Agreement is terminated by Endosonics pursuant to Section 10.2 above, the
licenses granted to CVD under Sections 2.2 of this Agreement shall continue
thereafter only as necessary to sell completed CVD products then on hand, in
the process of being manufactured or to meet CVD's then-existing supply
obligations.
ARTICLE XI
MISCELLANEOUS
XI.1 Assignment. This Agreement shall be binding upon and
inure to the benefit of the parties hereto, their respective subsidiaries,
successors and permitted assigns. Either party may freely assign this
Agreement to an acquiror of all or substantially all of its stock, business or
assets relating to this Agreement (whether by merger, acquisition or
otherwise).
XI.2 Notices. All notices given by either party under the
terms of this Agreement shall be in writing and personally delivered, sent by
certified mail (return receipt requested) or by commercial overnight courier
service to a party's address as set forth in the initial paragraph of this
Agreement. Notices shall be effective five (5) days after mailing or upon
actual receipt, whichever is sooner. Either party may change the person to
whom, or address to which, notice should be directed by giving written notice
thereof.
XI.3 Entire Agreement. This Agreement constitutes the
entire agreement and understanding between the parties and supersedes the
December 22, 1995 License Agreement between the parties in its entirety, and
all other previous or contemporaneous communications, memoranda, understandings
or agreements, either oral or written, between the parties with respect to the
subject matter hereof.
XI.4 Governing Law. This Agreement shall be governed by
and interpreted in accordance with the laws of the State of California without
regard to the conflicts of laws provisions thereof. The sole jurisdiction and
venue for actions related to the subject matter hereof shall be the California
state and U.S. federal courts having within their jurisdiction the location of
Endosonics's principal place of business. Both parties consent to the
jurisdiction of
8.
9
such courts and agree that process may be served in the manner provided herein
for giving of notices or otherwise as allowed by California state or U.S.
federal law. In any action or proceeding to enforce rights under this
Agreement, the prevailing party shall be entitled to recover costs and
attorneys' fees.
XI.5 Headings. Headings and captions are for convenience
only and are not to be used in the interpretation of this Agreement.
XI.6 Severability. If any provision of this Agreement is
held by a court of competent jurisdiction to be illegal, invalid or
unenforceable, that provision shall be limited or eliminated to the minimum
extent necessary so that this Agreement shall otherwise remain in full force
and effect and enforceable.
XI.7 Relationship of Parties. The parties hereto
expressly understand and agree that for the purposes of this Agreement the
other is an independent contractor in the performance of each and every part of
this Agreement and is solely responsible for all of its employees and agents
and its labor costs and expenses arising in connection therewith. This
Agreement in no way creates a partnership, joint venture or agency relationship
between the parties and neither party shall have the right or authority to bind
the other in any way as a result of this Agreement.
XI.8 Amendment and Waiver. Except as otherwise expressly
provided herein, any provision of this Agreement may be amended and the
observance of any provision of this Agreement may be waived (either generally
or in any particular instance and either retroactively or prospectively) only
with the written consent of the parties. The failure of either party to
enforce its rights under this Agreement at any time for any period shall not be
construed as a waiver of such rights.
9.
10
IN WITNESS WHEREOF, each party has caused this Agreement to be
executed by its duly authorized representative as of the day and year first
above written.
ENDOSONICS CORPORATION
By: __________________________________
Title: _______________________________
CARDIOVASCULAR DYNAMICS, INC.
By: __________________________________
Title: _______________________________
10.
11
EXHIBIT A
LICENSED PATENTS
o U.S. Patent No. 5,470,313
o U.S. Patent App. No. 08/201935
o EPO Patent App. No. 94119841.8
12
EXHIBIT B
ENDOSONICS TRANSDUCER
