Exhibit 10.66
LICENSE AGREEMENT
This Agreement is made and entered into as of October, 2000 (the Effective
Date), by and between CHILDREN'S MEDICAL CENTER CORPORATION, a charitable
corporation duly organized and existing under the laws of the Commonwealth of
Massachusetts and having its principal office at 000 Xxxxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxxxxx, 00000, X.X.X. (hereinafter referred to as "CMCC"), and NMT, Inc.
a business corporation organized and existing under the laws of the State of
Delaware and having its principal office at 00 Xxxxxxxx Xxxxxx, Xxxxxx, XX 00000
hereinafter referred to as "Licensee").
WHEREAS, CMCC is the owner of certain Study Data (as that term shall be
defined hereafter) and has the right to grant licenses for the use thereof;
desires to see Study Data utilized in the public interest and is willing to
grant a license thereunder on the terms and conditions described herein;
WHEREAS, Licensee desires to obtain a limited exclusive license under the
terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the parties hereto agree as follows:
ARTICLE I. DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall
have the meanings set forth below:
A. "Affiliate" shall mean any company or other legal entity controlling,
controlled by or under common control with Licensee. For purposes of the
definition of "Affiliate" the term "control" shall mean: (i) in the case of a
corporate entity, the direct or indirect ownership of at least a majority of the
stock or participating shares entitled to vote for the election of directors of
that entity; (ii) in the case of a partnership, the power customarily held by a
general partner to direct the management and policies of such partnership; or
(iii) in the case of a joint venture, whether in corporate, partnership or other
legal form, a more than nominal economic interest and managerial role.
B. "License Field" shall mean the preparation and prosecution of applications
to support a Product Marketing Application to the Food and Drug Administration
for Ventricular Septal Defect ("VSD") Closure using the CardioSEAL or STARflex
device.
C. "Licensee" shall mean Licensee and/or its successor(s) or assignee(s) and/or
its Affiliates.
D. "Study Data" shall mean data and results of the studies relating to VSD
Closure (including, but not limited to data obtained during the conduct of the
High Risk CardioSEAL study, the Clamshell registry and the STARflex VSD Study)
[FILL IN IRB NUMBERS] conducted under the supervision of Dr. Xxxxx Xxxxxxx,
between [FILL IN DATES OF STUDY].
E. "Sublicensee" shall mean a person or entity unaffiliated with Licensee to
who Licensee has granted an arm's length sublicense under this Agreement.
ARTICLE II. GRANT
CMCC hereby grants to Licensee a exclusive license to use Study Data solely
in the License Field for Five (5) years from the Effective Date of this
Agreement which shall be the term thereof, unless it shall be sooner terminated
as hereinafter provided.
ARTICLE III. DUE DILIGENCE
Licensee shall use the Study Data in a diligent manner to seek regulatory
approval for the CardioSEAL and/or STARflex device in the treatment of VSD with
the United States Food and Drug Administration ("FDA").
ARTICLE IV. PAYMENTS
A. For the provision of the High Risk current and updated CardioSEAL data,
NMT will make four quarterly payments of $25,000 each on January 1, 2001,
April 1, 2001, July 1, 2001, and October 1, 2001.
B. For provision of the existing Clamshell registry data, NMT will make a
single payment of $25,000 within thirty (30) days of the execution of this
Agreement. If updated information on Clamshell patients is requested by the FDA,
these data will be provided at no additional charge to NMT.
C. If STARflex data is to be provided to NMT either as part of the initial
application or as a supplement, a payment of $25,000 will be made on January 1,
2002.
ARTICLE V. UNIFORM INDEMNIFICATION AND INSURANCE PROVISIONS
A. Licensee shall indemnify, defend and hold harmless CMCC, its corporate
affiliates, current or future directors, trustees, officers, faculty, medical
and professional staff, employees, students and agents and their respective
successors, heirs and assigns (the "Indemnitees"), against any liability,
damage, loss or expense (including reasonable attorney's fees and expenses of
litigation) incurred by or impose upon the Indemnitees or any one of them in
connection with any claims, suits, actions, demands or judgments arising out of
any theory of product liability (including, but not limited to, actions in the
form of tort, warranty, or strict liability) concerning any product, process or
service made, used or sold pursuant to any right or license granted under this
Agreement.
B. Licensee's indemnification under Article VIII, Paragraph A above shall not
apply to any liability, damage, loss or expense to the extent that it is
directly attributable to the negligent activities, reckless misconduct or
intentional misconduct of the Indemnitees.
2
C. Licensee agrees, at its own expense, to provide attorneys reasonably
acceptable to CMCC to defend against any actions brought or filed against any
party indemnified hereunder with respect to the subject of indemnity contained
herein, whether or not such actions are rightfully brought.
D. Beginning at the time as any such product, process or service is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by Licensee or by a sublicensee, Affiliate or agent of
Licensee, Licensee 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 and naming the Indemnitees as
additional insureds. Such commercial general liability insurance shall provide
(i) product liability coverage and (ii) contractual liability coverage for
Licensee's indemnification under Article VIII, Paragraphs A through C of this
Agreement. If Licensee elects to self-insure all or part of the limits
described above (including deductibles or retentions which are in excess of
$250,000 annual aggregate), such self-insurance program must be acceptable to
CMCC and the Risk Management Foundation of the Harvard Medical Institutions,
Inc. The minimum amount of coverage required under this Article VIII, Paragraph
E shall not be construed to create a limited of Licensee's liability with
respect to its indemnification under Article VIII, Paragraphs A through C of
this Agreement.
E. Licensee shall provided CMCC with written evidence of such insurance upon
request of CMCC. Licensee shall provide CMCC with written notice at least
fifteen (15) days prior to the cancellation, non-renewal or material change in
such insurance. If Licensee does not obtain replacement insurance providing
comparable coverage within such fifteen (15) day period, CMCC shall have the
right to terminate this Agreement effective at the end of such fifteen (15) day
period without notice of any additional waiting periods.
F. Licensee shall maintain such commercial general liability insurance during
(i) the period that any such product or service is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by Licensee or by a sublicensee, Affiliate or agent of Licensee and
(ii) a reasonable period after the period referred to above, which in no event
shall be less than fifteen (15) years.
G. Article VIII, Paragraphs A through F shall survive expiration or termination
of this Agreement.
H. CMCC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK, SOFTWARE, TRADE
SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR DATA LICENSED OR OTHERWISE
PROVIDED TO LICENSEE HEREUNDER AND HEREBY DISCLAIMS THE SAME.
3
ARTICLE VI. NON-USE OF NAMES
Licensee shall not use the name of Children's Medical Center Corporation
nor the name of any of its corporate affiliates or employees, not any adaptation
thereof, in any advertising, promotional or sales literature without prior
written consent obtained from CMCC in each case, except that Licensee may state
that it is licensed by CMCC under one or more of the patents and/or applications
comprising the Patent Rights, and Licensee may comply with disclosure
requirements of all applicable laws relating to its business, including United
States and state security laws.
ARTICLE VII. ASSIGNMENT
A. Except as otherwise provided herein, this Agreement is not assignable in
whole or in part, and any attempt to do so shall be void and of no effect.
B. CMCC may assign this Agreement at any time to any corporate affiliate of
CMCC without the prior consent of Licensee.
C. Except as provided in Article XI, Paragraph D below, Licensee may assign
this Agreement to another entity only with the prior written consent of CMCC,
which consent shall not be unreasonably withheld or delayed.
D. Notwithstanding anything herein to the contrary, in the even Licensee merges
with another entity, is acquired by another entity, or sells all or
substantially all of its assets to another entity, Licensee may assign its
rights and obligations hereunder to, in the event of a merger or acquisition,
the surviving entity, and in the event of a sale, the acquiring entity, without
CMCC's consent so long as: (i) Licensee is not then in breach of this
Agreement; (ii) the proposed assignee has a net worth at least equivalent to the
net worth Licensee had as of the date of this Agreement; (iii) the proposed
assignee has available resources and sufficient scientific, business and other
expertise comparable to Licensee in order to satisfy its obligations hereunder;
(iv) Licensee provides written notice of the assignment to CMCC, together with
documentation sufficient to demonstrate the requirements set forth in
subparagraphs (i) through (iii) above, at least thirty (3) days prior to the
effective date of the assignment; and (v) CMCC receives from the assignee, in
writing, at least thirty (30) days prior to the effective date of the
assignment: (a) reaffirmation of the terms of this Agreement; (b) an agreement
to be bound by the terms of this Agreement; and (c) an agreement to perform the
obligations of Licensee under this Agreement.
ARTICLE VIII. TERM AND TERMINATION
A. The term of this Agreement shall be not less than five (5).
B. CMCC may terminate this Agreement immediately upon the bankruptcy,
insolvency, liquidation, dissolution or cessation of operations of Licensee; or
the filing of
4
any voluntary petition for bankruptcy, dissolution, liquidation or winding-up of
the affairs of Licensee; or any assignment by Licensee for the benefit of
creditors; or the filing of any involuntary petition for bankruptcy,
dissolution, liquidation or winding-up of the affairs of Licensee which is not
dismissed within ninety (90) days of the date on which it is filed or commenced.
C. CMCC may terminate this Agreement upon thirty (30) days prior written notice
in the event of Licensee's failure to make to CMCC payments due and payable
hereunder in a timely manner, unless Licensee shall make all such payments to
CMCC within said thirty (30) day period. Upon the expiration of the thirty (30)
day period, if Licensee shall not have made all such payments to CMCC, the
rights, privileges and licenses granted hereunder shall terminate.
D. Except as otherwise provided in Paragraph C above, CMCC may terminate this
Agreement upon sixty (60) days prior written notice in the event of Licensee's
breach or default of any material term or condition or warranty contained in
this Agreement, unless Licensee shall cure such breach to CMCC's reasonable
satisfaction within said sixty (60) day period. Upon the expiration of the
sixty (60) day period, if Licensee shall not have cured said breach to the
reasonable satisfaction of CMCC, the rights, privileges and license granted
hereunder shall terminate.
E. Licensee shall have the right to terminate this Agreement at any time upon
thirty (30) prior written notice to CMCC if CMCC shall fail to deliver data in a
timely manner.
ARTICLE X. PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
A. All payments, notices, reports and/or other communications made in
accordance with this Agreement, shall be sufficiently made or given on the date
of the mailing if delivered by hand, by facsimile or sent by first class mail
postage prepaid and addressed as follows:
In the case of CMCC:
Chief Intellectual Property Officer
Intellectual Property Office
Children's Hospital
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
In the case of Licensee:
President
NMT, Inc.
00 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
or such other address as either party shall notify the other in writing.
5
ARTICLE XI. GENERAL PROVISIONS
A. All rights and remedies hereunder will be cumulative and not alternative,
and this Agreement shall be construed and governed by the laws of the
Commonwealth of Massachusetts.
B. This Agreement may be amended only by written agreement signed by the
parties.
C. It is expressly agreed by the parties hereto that CMCC and Licensee are
independent contractors and nothing in this Agreement is intended to create an
employer relationship, joint venture, or partnership between the parties. No
party has the authority to bind the other.
D. This Agreement constitutes the entire agreement between the parties with
respect to the subject matter hereof and supersedes all proposals, negotiations
and other communications between the parties, whether written or oral, with
respect to the subject matter hereof.
E. If any provisions of this Agreement shall be held to be invalid, illegal or
unenforceable, the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired thereby.
F. This Agreement may be executed in any number of counterparts, each of which
shall be deemed an original as against the party whose signature appears thereon
but all of which taken together shall constitute but one and the same
instrument.
G. The failure of either party to assert a right to which it is entitled or to
insist upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar or subsequent failure to
perform any such term or condition by the other party.
H. Licensee agrees to xxxx any Licensed Products sold in the United States with
all applicable United States patent numbers. All Licensed Products shipped to
or sold in other countries shall be marked in such a manner as to conform with
the patent laws and practices of the country of manufacture or sale.
I. Each party hereto agrees to execute, acknowledge and deliver such further
instruments and do all such further acts as may be necessary or appropriate to
carry out the purposes and intent of this Agreement.
J. The paragraph headings contained in this Agreement are for references
purposes only and shall not in any way affect the meaning or interpretation of
this Agreement.
6
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
last written below.
CHILDREN'S MEDICAL CENTER CORPORATION LICENSEE
By: /s/ Xxxxxxx New By: /s/ Xxxx X. Xxxxx
----------------------------------------- ---------------------------
Name: Xxxxxxx New Name: Xxxx Xxxxx
--------------------------------------- -------------------------
Title: Vice President Research Administration Title: President / CEO
-------------------------------------- ------------------------
Date: 1/11/01 Date: 1/5/01
--------------------------------------- -------------------------
7
