EXHIBIT 10.73
LICENSE AGREEMENT
AMENDMENT NO. 2
THIS AMENDMENT NO. 2 TO THE LICENSE AGREEMENT ("Second Amendment") is
made and entered into effective as of November 30, 1999, ("Second Amendment
Date") by and between SYNTEX (U.S.A.) INC. ("Syntex") having offices at 0000
Xxxxxxxx Xxxxxx, Xxxx Xxxx, Xxxxxxxxx 00000, and CV THERAPEUTICS, INC. ("CVT")
having an address at 0000 Xxxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxxxx 00000. Capitalized
Terms used in the Amendment that are not otherwise defined herein shall have the
same meanings as such terms are defined in the License Agreement.
RECITALS
Syntex and CVT entered into the License Agreement effective March 27,
1996 ("License Agreement") and entered into an Amendment to the License
Agreement effective July 3, 1997 ("Amendment"). The License Agreement as amended
by the Amendment and this Amendment No. 2 shall constitute the "Agreement."
The parties now wish to amend the Agreement to change the milestones
and payments associated with those milestones.
NOW, THEREFORE, in consideration of the mutual promises contained
herein, the sufficiency of which is hereby acknowledged, Syntex and CVT now wish
to amend the Agreement as follows:
1. DELETION OF SECTION 4.5 AND EXHIBIT B. Section 4.5 of and
Exhibit B to the License Agreement are hereby deleted in their entirety.
2. AMENDMENT OF SECTION 5.1(b). Section 5.1(b) of the License
Agreement is hereby amended and replaced in its entirety with the following:
(1) NDA FILING. CVT shall use its best efforts to file
an NDA for a Licensed Product no later than June 1,
2001.
(2) FIRST NDA PAYMENT. If the first approval of an NDA or
equivalent in one of the Major Market Countries
occurs before May 1, 2002, CVT shall pay to Syntex on
or before March 31, 0000 xxxxx xxxxxxx Xxxxxx Xxxxxx
dollars (US $7,000,000), plus all accrued interest
thereon (interest shall accrue on the payment from
the date of approval of such NDA or equivalent until
the date payment is made at the rates set forth in
the Interest Table). If the first approval of an NDA
or equivalent in one of the Major Market Countries
occurs after May 1, 2002, CVT shall pay to Syntex on
or before March 31, 0000 xxxxx xxxxxxx Xxxxxx Xxxxxx
dollars (US $7,000,000), plus all accrued interest
thereon (interest shall accrue on the payment from
May 1, 2002 until the date payment is made at, the
rates set forth in the Interest Table).
(3) SECOND NDA PAYMENT. In addition to the payment in
Section 5.1(b)(2) above, if the second approval of an
NDA or equivalent in one of the Major Market
Countries occurs before May 1, 2004, CVT shall pay to
Syntex on or before March 31, 0000 xxxxx xxxxxxx
Xxxxxx Xxxxxx dollars (US $7,000,000), plus all
accrued interest thereon (interest shall accrue on
the payment from the date of approval of such NDA or
equivalent until the date payment is made at the
rates set forth in the Interest Table). If the second
approval of an NDA or equivalent in one of the Major
Market Countries occurs after May 1, 2004 but before
March 31, 2006, CVT shall pay to Syntex on or before
March 31, 0000 xxxxx xxxxxxx Xxxxxx Xxxxxx dollars
(US $7,000,000), plus all accrued interest thereon
(interest shall accrue on the payment from May 1,
2004 until the date payment is made at the rates set
forth in the Interest Table). If the second approval
of an NDA or equivalent in one of the Major Market
Countries has not occurred by March 31, 2006, CVT
shall pay to Syntex on or before March 31, 0000 xxxxx
xxxxxxx Xxxxxx Xxxxxx dollars (US $3,000,000). If,
after March 31, 2006, CVT receives the second
approval of an NDA or equivalent in one of the Major
Market Countries, CVT shall pay to Syntex four
million United States dollars (US $4,000,000) within
thirty (30) days of the date of such second NDA or
equivalent approval,
(4) For purpose of this Section 5.1, "Major Market
Countries" shall mean the United States, France,
Germany, Italy and the United Kingdom.
(5) For purpose of this Section 5.1 "Interest Table"
shall mean the following interest table.
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TIME PERIOD ANNUAL INTEREST RATE
(CALENDAR YEAR)
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2000 13%
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2001 14%
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2002 15%
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2003 16%
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2004 18%
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2005 20%
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3. AMENDMENT OF SECTION 11.3. Section 11.3 of the License
Agreement is hereby amended and replaced in its entirety with the following:
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11.3 Failure by one party to comply with any of its
respective obligations contained in this Agreement
shall entitle the other party to give the party in
default written notice of such default. If such
default is not remedied within ninety (90) days after
receipt of such notice (or thirty (30) days in the
event of non-payment of fees other than those
contained in Section 5.1(b)), the notifying party
shall be entitled to terminate this Agreement by
giving notice with immediate effect The right of
either party to terminate this Agreement as provided
hereinabove shall not be affected in any way by its
waiver of or failure to take actions with respect to
any previous default. In such cases of breach by CVT,
all licenses from CVT to Syntex as set forth below in
Section 11.4 for the case of any early termination
shall be royalty free, and CVT shall provide Syntex
all of the information required by Section 11.4 in
the event of early termination or breach of this
Agreement by CVT. Notwithstanding anything else
contained in this Agreement, if CVT fails to make any
payment under Section 5.1(b) on or prior to the due
date, Syntex may in its sole discretion terminate
this Agreement with immediate effect. If there is any
BONA FIDE dispute between the parties regarding the
right of termination based on failure by CVT to make
a milestone or royalty payment (other than those
contained in Section 5.1(b)), as the case may be, the
disputed royalty or milestone payment shall be paid
into an interest bearing account by CVT where it
shall remain during the pendency of the dispute, and
upon resolution of the dispute, paid, with
accumulated interest, to the prevailing party. For
purposes of Section 5.1, the payment shall be deemed
paid on the date such payment is paid into the
interest bearing account.
4. AMENDMENT OF ARTICLE 11. A new section 2.6 is added to the
Agreement as follows:
2.6 CVT may grant rights to CVT Patents and Know-How
and/or Syntex Patents and Know-How to any Veterans
Administration hospitals at which CVT conducts
clinical trials of the Compound, provided the grant
of rights is at least as restrictive as the following
language:
Rights to any information, inventions, or discoveries
(whether patentable, copyrightable or not),
innovations, suggestions, ideas, communications, and
reports (collectively "Inventions"), conceived,
reduced to practice, made or developed by the
Principal Investigator or the Department of Veterans
Affairs ("DVA') as a result of conducting a Study are
controlled by Federal Law (35 U.S.C. 200-212, 37 XXX
000, 00 XXX 1.650-666). However, if DVA of Principal
Investigator obtains ownership of such Inventions
arising from research conducted under a Study,
Sponsor shall have the option to obtain a sole and
exclusive worldwide license to all of DVA's and/or
Principal Investigator's rights any such Invention.
DVA and Principal Investigator shall promptly notify
Sponsor in writing of any such Invention ("Notice").
Within one hundred and eighty (180) days after
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Sponsor receives Notice, Sponsor and DVA and/or
Principal Investigator shall enter into good faith
negotiations directed to an agreement whereby Sponsor
acquires sole and exclusive worldwide rights to such
Invention, subject to the right of the United States
to retain an irrevocable, royalty-free right to use
the Invention throughout the United States. The
license agreement shall contain reasonable terms and
conditions which are usual and customary for
pharmaceutical products at a like stage of
development, which shall include a royalty for such
license based upon the relative contributions to the
Invention by the Principal Investigator and the
commercial value of such Invention. In the event that
the parties cannot agree, after good faith
negotiations, to an exclusive license agreement, then
Sponsor shall have a right of first refusal to accept
any terms offered to a third party for rights to the
Invention.
The granting of such rights by CVT to the Veterans
Administration hospitals shall not constitute a
breach by CVT of this Agreement, and such rights
shall not terminate upon termination of the
Agreement. The grant of such rights to the Veterans
Administration hospitals shall not be limited to
Cardiovascular Indications, but shall apply to any
indications for such inventions.
5. FULL FORCE AND EFFECT. This Amendment No, 2 amends the terms
of the License Agreement and the Amendment and is deemed incorporated into,
and governed by all the other terms of, the License Agreement and Amendment.
The provisions of the License Agreement, as amended by the Amendment and this
Amendment No. 2, remain in full force and effect.
IN WITNESS WHEREOF, the parties have executed this Amendment to be
effective as of the Second Amendment Date.
SYNTEX (U.S.A.) INC. CV THERAPEUTICS, INC.
By: By:
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Name: XXXXX X. XXXXX Name: XXXXX XXXXX
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Title: PRESIDENT Title: CHAIRMAN AND CEO
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Date: 12/21/99 Date: 12/9/99
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