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 10.44
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 [ * ]. 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, [ * ] upon the [ * ] but in no
event later than [ * ];
2) [ * ] upon the approval of the [ * ].
* Confidential Treatment Requested.
For the purposes of this Section 5.1(b), [ * ] shall mean
any of the following [ * ] and [ * ] shall mean [ * ].
3) [ * ] upon the [ * ]. In the event that [ * ] then a
[ * ] milestone payment shall be due from CVT to Syntex at
the [ * ] milestone payment in the event that such [ * ]
milestone payment is subsequently made by CVT to Syntex.
In the event [ * ].
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 [ * ]
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.
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:
* Confidential Treatment Requested.
2.
(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 Shares many
not be sold pursuant to Rule 144 promulgated
3.
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 LICENSED APPLICABLE ROYALTY RATE
PRODUCT [ * ]
Up to [ * ] million [ * ]
Greater than [ * ] million but [ * ]
less than [ * ] million
* Confidential Treatment Requested.
4.
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 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.
* Confidential Treatment Requested.
5.
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
-----------------------------------
Name: Xxxxx X. Xxxxxx
---------------------------------
Title: V.P.
--------------------------------
Date: 8/4/97
---------------------------------
CV THERAPEUTICS, INC.
By: /s/ Xxxxx Xxxxx
-----------------------------------
Name: Xxxxx Xxxxx
---------------------------------
Title: CEO
--------------------------------
Date: 7/23/97
---------------------------------
6.
