Exhibit 10.1
MASTER AGREEMENT
This MASTER AGREEMENT (this “
Agreement ”) is made and entered into as of this 2
nd day of June, 2005, by and between Edwards
Lifesciences PVT, Inc., a Delaware corporation (“
Edwards ”), and 3F Therapeutics, Inc., a Delaware
corporation (“ 3F Therapeutics ” and, together
with Edwards, are each referred to herein as a “ Party
” and collectively as the “ Parties
”).
RECITALS
WHEREAS, reference is made to
(i) the Development and Supply Agreement, dated as of
June 13, 2002, as amended by the First Amendment to
Development and Supply Agreement, dated as of October 31,
2002, and the Second Amendment to Development and Supply Agreement,
dated as of May 27, 2003 (as so amended, the “ 3F
Development and Supply Agreement ”), by and between 3F
Therapeutics and Edwards (as successor to Percutaneous Valve
Technologies, Inc. (“ PVT ”)) and
(ii) the Development Agreement, dated as of November 14,
2001, as amended by the First Amendment to Development Agreement,
dated as of October 31, 2002 and the Second Amendment to
Development Agreement, dated as of May 27, 2003 (as so
amended, the “ VenPro Development Agreement ”
and, together with the 3F Development and Supply Agreement, the
“ Subject Agreements ”), by and between 3F
Therapeutics (as successor to VenPro Corporation (“
VenPro ”)) and Edwards (as successor to
PVT);
WHEREAS, Edwards, as successor in
interest to PVT under the Subject Agreements, and 3F Therapeutics,
under the 3F Development and Supply Agreement and as successor in
interest to VenPro under the VenPro Development Agreement, mutually
desire to terminate the Subject Agreements and to release one
another of certain liabilities and obligations between the Parties
under the Subject Agreements, all upon the terms and subject to the
conditions set forth in this Agreement;
WHEREAS, in connection with the
termination of the Subject Agreements pursuant to this Agreement,
the Parties have agreed that (i) Edwards shall grant to 3F
licenses with respect to certain of Edwards’ patent and
patent applications, upon the terms and subject to the conditions
set forth in a license agreement in the form attached as
Exhibit A hereto (the “ Edwards License
Agreement ”), (ii) 3F Therapeutics shall grant to
Edwards licenses to produce and sell products incorporating certain
of 3F Therapeutics’ manufacturing know-how and intellectual
property, upon the terms and subject to the conditions set forth in
a license agreement in the form attached as Exhibit B
hereto (the “ 3F License Agreement ”) and
(iii) 3F Therapeutics shall supply Edwards with certain
products and provide Edwards with training with respect to certain
of 3F Therapeutics’ know-how and intellectual property needed
by Edwards in connection with certain of Edwards’
manufacturing processes, upon the terms and subject to the
conditions set forth in a supply and training agreement in the form
attached as Exhibit C hereto (the “ Supply and
Training Agreement ” and, together with the Edwards
License Agreement and 3F License Agreement, the “ Related
Transaction Agreements ”); and
WHEREAS, in connection with the
transactions contemplated by this Agreement and upon the terms and
subject to the conditions contained herein, Edwards shall pay to
3F
Therapeutics, or cause to be paid to 3F
Therapeutics on its behalf, the consideration set forth
herein.
NOW, THEREFORE, in consideration of
the premises and the mutual covenants and agreements hereinafter
set forth, the Parties agree as follows:
1.
TERMINATION OF THE SUBJECT
AGREEMENTS AND RELEASE. Effective on the Closing Date (as defined
below):
1.1
Termination
. Upon the terms and subject
to the conditions contained in this Agreement, the Subject
Agreements shall be irrevocably terminated and extinguished in
their entirety as of the Closing Date, and upon such termination
and extinguishment, no provision of either of the Subject
Agreements shall have any force or effect.
1.2
No Surviving
Provisions .
Notwithstanding any provision in any Subject Agreement providing
for the survival of such provision or any other provision following
termination of such Subject Agreement (each such provision and
other provision, a “ Non-Surviving Provision ”),
the parties hereby agree that no provision contained in either
Subject Agreement shall survive the termination and extinguishment
of the Subject Agreements pursuant to this Agreement.
1.3
Release . Each of Edwards, on the one hand, and 3F
Therapeutics, on the other hand, on behalf of itself and each of
its respective affiliates, employees, agents, successors and
assigns (each, a “ Releasing Party ”), hereby
fully releases and discharges the other and each of its respective
affiliates, employees, agents, successors and assigns (each, a
“ Released Party ”), from, and to the extent
applicable, relinquishes, all rights, obligations, liabilities,
claims and actions, whether known or unknown, now existing or
hereafter arising, at law or in equity or otherwise, that each such
Releasing Party now has or may have against any Released Party,
arising out of or in connection with the Subject Agreements (the
“ Released Obligations ”); provided, however,
that the outstanding obligations of Edwards to 3F Therapeutics and
the outstanding obligations of 3F Therapeutics to Edwards, each as
set forth in Exhibit D , shall not be
released.
2.
CLOSING AND PAYMENT OF THE
CONSIDERATION.
2.1
Closing . The closing (the “ Closing
”) of the transactions contemplated under this Agreement
shall take place on the date both Parties have executed and
delivered this Agreement.
2.2
Consideration for Termination of
Subject Agreements . In full consideration of the termination
of the Subject Agreements in accordance with Section 1 above,
Edwards agrees to pay to 3F Therapeutics, or cause to be paid to 3F
Therapeutics on its behalf, the aggregate sum of up to twenty four
million seven hundred fifty thousand dollars and no cents
($24,750,000.00), as follows:
(a)
On the Closing Date, Edwards shall
pay to 3F Therapeutics, or cause to be paid to 3F Therapeutics on
its behalf, the sum of twenty two million seven hundred fifty
thousand dollars and no cents ($22,750,000.00) (the “
Initial Termination Fee ”), by wire transfer of
immediately available funds to an account designated by 3F
Therapeutics; and
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(b)
On the date that is the first
business day following the expiration of the Term (as such term is
defined in the Supply and Training Agreement) of the Supply and
Training Agreement in accordance with its terms, or such other date
as the Parties may mutually determine (the “ Transitional
Agreement Termination Date ”), Edwards shall pay to 3F
Therapeutics, or cause to be paid to 3F Therapeutics on its behalf,
the sum of two million dollars and no cents ($2,000,000.00) (the
“ Holdback Amount ”), by wire transfer of
immediately available funds to an account designated by 3F
Therapeutics, provided, however , that Edwards’
obligations under this Section 2.2(b) shall be subject to
the condition that there shall not have been any breach by 3F
Therapeutics of any of its obligations under the Supply and
Training Agreement as provided in Section 5.6 thereof at any
time during the Term. In the event that the aforementioned
condition is not satisfied, Edwards shall have no obligation to pay
to 3F Therapeutics, or cause to be paid to 3F Therapeutics on its
behalf, any portion of the Holdback Amount under this
Section 2.2(b).
2.3
Consideration for 3F License
Agreement . In full
consideration of the execution and delivery of the 3F License
Agreement by 3F Therapeutics, Edwards shall pay to 3F Therapeutics
on the Closing Date, or cause to be paid to 3F Therapeutics on its
behalf, the sum of two hundred fifty thousand dollars and no cents
($250,000.00) (the “ License Agreement Fee ”),
by wire transfer of immediately available funds to an account
designated by 3F Therapeutics.
2.4
Full Consideration
. 3F Therapeutics hereby
agrees that the Initial Termination Fee, the Holdback Amount (to
the extent that Edwards is obligated to pay, or cause to be paid on
its behalf, the Holdback Amount under the provisions of
Section 2.2(b)) and the License Agreement Fee shall constitute
consideration in full for 3F Therapeutics’ agreement to be
bound by the provisions in this Agreement.
2.5
Documents to be
Delivered .
Concurrently with the consummation of the transactions set forth in
Sections 2.2 and 2.3 on the Closing Date, each Party shall duly
execute and deliver to the other Party each of the Related
Transaction Agreements.
3.
REPRESENTATIONS AND WARRANTIES OF
EDWARDS . Edwards
represents and warrants to 3F Therapeutics, as of the Closing
Date:
3.1
Organization and Corporate
Power . Edwards is
a corporation duly organized, validly existing, and in good
standing under the laws of the State of Delaware, and has all
required corporate power and corporate authority to perform its
obligations under this Agreement.
3.2
Authorization and
Approval . The
execution, delivery and performance by Edwards of each of this
Agreement and the Related Transaction Agreements have been duly
authorized by all necessary corporate action of Edwards, including
approval of such execution, delivery and performance by the board
of directors of Edwards. Edwards has duly executed and
delivered each of this Agreement and the Related Transaction
Agreements, which constitutes the valid and legally binding
obligation of Edwards, enforceable in accordance with its terms,
except that enforcement thereof may be limited by
(a) applicable bankruptcy, insolvency, reorganization,
moratorium and other laws of general application affecting
enforcement of creditors’ rights generally and
(b) general principles of equity, whether such enforceability
is considered in a proceeding in equity or at law.
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3.3
Agreements
. Edwards acknowledges that
the Subject Agreements constitute all of the agreements, whether
written or oral, entered into by and between the Parties with
respect to the subject matter covered under the Subject Agreements,
and that the termination of the Subject Agreements and the release
of the Released Obligations pursuant to this Agreement effectively
terminates all and any agreements or arrangements between the
Parties with respect to such subject matter (including each
Non-Surviving Provision) and releases 3F Therapeutics of all and
any liabilities and obligations under all such agreements and
arrangements, except those set forth in Exhibit D as
referenced in Section 1.3 hereof.
4.
REPRESENTATIONS AND WARRANTIES OF
3F THERAPEUTICS.
3F Therapeutics represents and warrants to Edwards, as of the
Closing Date:
4.1
Organization and Corporate
Power . 3F
Therapeutics is a corporation duly organized, validly existing, and
in good standing under the laws of the State of Delaware, and has
all required corporate power and corporate authority to perform its
obligations under this Agreement.
4.2
Authorization and
Approval . The
execution, delivery and performance by 3F Therapeutics of each of
this Agreement and the Related Transaction Agreements have been
duly authorized by all necessary corporate action of 3F
Therapeutics, including approval of such execution, delivery and
performance by the board of directors of 3F Therapeutics. 3F
Therapeutics has duly executed and delivered each of this Agreement
and the Related Transaction Agreements, which constitutes the valid
and legally binding obligation of 3F Therapeutics, enforceable in
accordance with its terms, except that enforcement thereof may be
limited by (a) applicable bankruptcy, insolvency,
reorganization, moratorium and other laws of general application
affecting enforcement of creditors’ rights generally and
(b) general principles of equity, whether such enforceability
is considered in a proceeding in equity or at law.
4.3
Agreements
. 3F Therapeutics acknowledges
that the Subject Agreements constitute all of the agreements,
whether written or oral, entered into by and between the Parties
with respect to the subject matter covered under the Subject
Agreements, and that the termination of the Subject Agreements and
the release of the Released Obligations pursuant to this Agreement
effectively terminates all and any agreements or arrangements
between the Parties with respect to such subject matter (including
each Non-Surviving Provision) and releases Edwards of all and any
liabilities and obligations under all such agreements and
arrangements, except those set forth in Exhibit D as
referenced in Section 1.3 hereof.
5.
MATTERS REGARDING TERMINATION AND
RELEASE.
5.1
Certain Agreements and
Acknowledgements.
(a)
3F Therapeutics hereby agrees and
acknowledges that it shall not use or otherwise access any data,
results and information generated by the testing, analysis,
evaluation, or other means of the Investigational PVT Product (as
defined in the 3F Development and Supply Agreement) (such data,
results and information, the “ Test Data ”);
provided , however , that
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3F Therapeutics shall have the right to use in
the Surgical Field of Use (as such term is defined in the 3F
License Agreement) (i) any Test Data that is in 3F
Therapeutics’ possession as of the Closing Date and as set
forth on Exhibit E and (ii) any additional Test
Data in Edwards’ possession that was generated by Edwards
prior to the Closing Date, to the extent required for regulatory
purposes.
(b)
Edwards hereby acknowledges that
(i) no license with respect to 3F Technology (as such term is
defined in the 3F Development and Supply Agreement) was granted to
Edwards or PVT by 3F Therapeutics by operation of Section 6.18
of the 3F Development and Supply Agreement and (ii) neither it
nor PVT has obtained any right to exercise, or has exercised, the
license with respect to 3F Patents (as such term is defined in the
3F Development and Supply Agreement) pursuant to Section 7.3
of the 3F Development and Supply Agreement.
(c)
3F Therapeutics hereby acknowledges
that (i) no license with respect to PVT Technology (as such
term is defined in the 3F Development and Supply Agreement) was
granted to 3F Therapeutics by Edwards or PVT by operation of
Section 6.16 of the 3F Development and Supply Agreement and
(ii) it has not obtained the right to, and has not, exercised
the license with respect to PVT Patents (as such term is defined in
the 3F Development and Supply Agreement) pursuant to
Section 7.2 of the 3F Development and Supply
Agreement.
(d)
3F Therapeutics hereby acknowledges
that (i) no license with respect to PVT Patents (as such term
is defined in the VenPro Development Agreement) was granted to 3F
Therapeutics or VenPro by Edwards or PVT by operation of
Section 6.10 of the VenPro Development Agreement and
(ii) neither it nor VenPro has obtained any right to exercise,
or has exercised, the license with respect to PVT Patents (as
such
