Confidential treatment has been
requested for portions of this
document. Brackets indicate portions
of text that have been omitted. A
separate filing of such omitted text
has been made with the Commission as
part of the Company's application
for confidential treatment.
EXHIBIT 10.32
AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT TO LICENSE AGREEMENT (the "Amendment") is made and
entered into effective as of July 3, 1997 (the "Amendment Date"), by and between
CV THERAPEUTICS, INC., a Delaware corporation having its principal place of
business at 0000 Xxxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000 ("CVT"), and SYNTEX
(U.S.A.), INC., a Panamanian corporation whose address is 0000 Xxxxxxxx Xxxxxx,
Xxxx Xxxx, Xxxxxxxxxx 00000 ("Syntex"). Capitalized terms used in this Amendment
that are not otherwise defined herein shall have the same meanings as such terms
are defined in the Prior Agreement (as defined below).
RECITALS
A. CVT and Syntex entered into a License Agreement dated March 27, 1996
(the "Prior Agreement"), under which Syntex granted to CVT an exclusive license
in the CVT Territory to develop, register, make or have made, use, offer for
sale, sell, or import the Compound.
B. The parties desire to amend the terms of the Prior Agreement to set
forth new milestone payments to replace those in the Agreement, to provide for
CVT to issue to Syntex a certain number of shares of CVT registered common stock
and to establish royalty rates on Net Sales of Licensed Products marketed by CVT
with a third party partner. The Prior Agreement, as amended by this Amendment,
shall constitute the "Agreement."
NOW, THEREFORE, the parties agree as follows:
1. AMENDMENT OF THE PRIOR AGREEMENT
The parties hereby agree to amend the terms of the Prior Agreement as
of the Amendment Date as provided below.
1.1 AMENDMENT OF SECTION 5.1(b). Section 5.1(b) of the Prior
Agreement is hereby amended and restated to read in its entirety as follows:
"b) CVT will pay Syntex the following additional amounts
in milestone payments upon the first occurrence of
each of the following milestones in the CVT Territory
as follows:
1) Subject to 5.1(c) below, One Million Dollars
($1,000,000) upon the identification of the
mechanism of action of the Compound but in
no event later than July 3, 1997;
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2) Seven Million Dollars ($7,000,000) upon the
first NDA approval of a Licensed Product for
sale by the approval authority equivalent to
the FDA in a major market in Europe or by
the rapporteur in a European country with a
rapporteur system or by the EMEA for EU-wide
approval. For the purposes hereof, "major
market" shall mean any of the following
countries: France, Germany, Italy and the
United Kingdom; and "rapporteur" shall mean
a country in which a product registration
serves as a basis for obtaining by reference
a registration on the same product in
another country.
For the purposes of this Section 5.1(b), [ * ]
shall mean any of the following [ * ] and [ * ] shall mean [ * ].
3) Seven Million Dollars ($7,000,000) upon the
approval of the NDA (or comparable
application) for sale of a Licensed Product
by the FDA or the approval authority
equivalent to the FDA in a second major
market country or by the rapporteur in a
European country with a rapporteur system or
by the EMEA for EU-wide approval. In the
event that no second NDA approval is given
within two (2) years of the first NDA
approval, then a Three Million Dollar
($3,000,000) milestone payment shall be due
from CVT to Syntex at the end of such two
(2) year period, creditable against the
second Seven Million Dollar ($7,000,000)
milestone payment in the event that such
second Seven Million Dollar ($7,000,000)
milestone payment is subsequently made by
CVT to Syntex. In the event rapporteur
approval resulted in a payment under
paragraph 2 above, then the payment under
this paragraph 3 shall be due upon receipt
of actual approval for sale (which shall not
require pricing approval) in a second major
market country.
1.2 EQUITY. The parties hereby agree to amend Section 5.1 of the Prior
Agreement to add new subsections 5.1(d) and 5.1(e) which will read in their
entirety as follows:
"EQUITY
d) Upon the Amendment Date, CVT shall issue to Syntex
seventy-five thousand (75,000) shares of CVT's common
stock (the "Shares"). As soon as practicable after
November 22, 1997, CVT shall file a registration
statement with the Securities and Exchange Commission
under the Securities Act of 1933, as amended (the
"Securities Act") covering the registration of the
Shares. CVT shall use all reasonable efforts to cause
such registration statement to be declared effective,
and to keep such registration statement effective
until the earlier of three hundred sixty five (365)
days following the effective date or the date that
Syntex has completed the distribution related
thereto.
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e) Syntex understands that the Shares have not been
registered under the Securities Act. Syntex
understands that the Shares are being offered and
sold pursuant to an exception from registration
contained in the Securities Act based on Syntex's
representations contained in this Amendment. Syntex
hereby represents and warrants as follows:
(1) Syntex has substantial experience in
evaluating and investing in private
placement transactions of securities in
companies similar to CVT so that it is
capable of evaluating the merits and risks
of its investment in CVT and has the
capacity to protect its own interests.
Syntex must bear the economic risk of this
investment indefinitely unless the Shares
are registered pursuant to the Securities
Act or an exemption from registration is
available.
(2) Syntex is acquiring the Shares for its own
account for investment only, and not with a
view towards their distribution.
(3) Syntex represents that by reason of its
management's business or financial
experience, Syntex has the capacity to
protect its interests in connection with the
transactions contemplated by this Amendment.
Syntex is not aware of any publication or
advertisement in connection with the
transactions contemplated in the Amendment.
(4) Syntex represents that it is an accredited
investor within the meaning of Regulation D
under the Securities Act.
(5) Syntex has received: (i) CVT's Annual Report
on Form 10-K for the year ended December 31,
1996, including the audited financial
statements contained therein; (ii) CVT's
Quarterly Report on Form 10-Q for the
quarter ended March 31, 1997, including the
unaudited financial statements contained
therein; (iii) CVT's Annual Report to
Stockholders; and (iv) CVT's Annual Proxy
Statement for the 1997 Annual Meeting of
Stockholders. Syntex has had an opportunity
to discuss CVT's business, management and
financial affairs with CVT's directors,
officers and management and has had the
opportunity to ask questions of and receive
answers from CVT and its management
regarding the terms and conditions of this
investment.
(6) Syntex understands that the Shares may not
be sold, transferred or otherwise disposed
of without registration under the Securities
Act or an exemption therefrom, and that in
the absence of an effective registration
statement covering the Shares or an
available exemption from registration under
the Securities Act, the Shares must be held
indefinitely. In particular, Syntex is aware
that the
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Shares many not be sold pursuant to
Rule 144 promulgated under the Securities
Act unless all of the conditions of that
Rule are met.
(7) The certificate evidencing the Shares shall
be endorsed with the following legend:
"THE SHARES REPRESENTED HEREBY HAVE NOT BEEN
REGISTERED UNDER THE SECURITIES ACT OF 1933,
AS AMENDED, AND MAY NOT BE SOLD,
TRANSFERRED, ASSIGNED, PLEDGED OR
HYPOTHECATED UNLESS AND UNTIL REGISTERED
UNDER SUCH ACT, OR UNLESS THE COMPANY HAS
RECEIVED AN OPINION OF COUNSEL OR OTHER
EVIDENCE, SATISFACTORY TO THE COMPANY AND
ITS COUNSEL THAT SUCH REGISTRATION IS NOT
REQUIRED."
1.3 AMENDMENT OF SECTION 5.2. Section 5.2 of the Prior Agreement
is hereby amended and restated to read in its entirety as follows:
"5.2 CVT shall pay the following royalties to Syntex on Net Sales of
the Licensed Products. Such royalties shall be paid on a product-by-product and
country-by-country basis according to the following rates:
a) For Net Sales of a Licensed Product as to which
Syntex Patents and Know-How cover the manufacture,
use, sale, offer for sale, or import of the Licensed
Product, and which Licensed Product is [ * ] a rate
of [ * ].
b) For Net Sales of a Licensed Product as to which
Syntex Patents and Know-How cover the manufacture,
use, sale, offer for sale, or import of the Licensed
Product and which Licensed Product is [ * ] the
royalty rate shall be determined under the following
schedule for the applicable amount of world-wide Net
Sales on an annual basis, incrementally applied.
ANNUAL NET SALES OF APPLICABLE ROYALTY
LICENSED PRODUCT [ * ] RATE
Up to [ * ] million [ * ]
Greater than [ * ] million but [ * ]
less than [ * ] million
Greater than [ * ] million [ * ]
For example, in the event that Net Sales of Licensed
Products during a particular calendar year under
Section 5.2 b) are [ * ] million, the royalty
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rate on the first [ * ] million of Net Sales will be
[ * ] and the royalty rate on the subsequent [ * ]
million of Net Sales will be [ * ].
c) For sales of a Licensed Product in a country of the
CVT Territory in which competition by products having
the same active compound as the Licensed Product
exceeds [ * ] in terms of unit sales, based on IMS
data or equivalent independent survey, a royalty
reduced to [ * ] of the rates shown in Section 5.2 a)
or 5.2 b) above for as long as such competition
continues to exceed [ * ]."
2. MISCELLANEOUS
2.1 FULL FORCE AND EFFECT. This Amendment amends the terms of the Prior
Agreement and is deemed incorporated into, and governed by all the other terms
of, the Prior Agreement. The provisions of the Agreement, as amended by this
Amendment, remain in full force and effect.
2.2 COUNTERPARTS. This Amendment may be executed in two or more
counterparts, each of which shall be deemed an original, but both of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Amendment in
duplicate originals by their authorized officers as of the date and year first
above written.
SYNTEX (U.S.A.), INC.
By: /s/ Xxxxx X. Xxxxxx
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Name: Xxxxx X. Xxxxxx
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Title: V.P.
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Date: 8/4/97
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CV THERAPEUTICS, INC.
By: /s/ Xxxxx Xxxxx
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Name: Xxxxx Xxxxx
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Title: CEO
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Date: 7/23/97
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