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Exhibit 10.58
***Text Omitted and Filed Separately with the Securities and
Exchange
Commission. Confidential Treatment Requested
Under
17 C.F.R. Sections 200.80(b)(4) and
240.24b-2
AMENDMENT
AMENDMENT dated
October 29, 2007 to the Sublicense and Development Agreement
dated June 30, 1998 (the “Sublicense Agreement”)
by and between DOV Pharmaceutical, Inc. 150 Pierce St., Somerset,
NJ 08873 (“DOV”) and Neurocrine Biosciences, Inc.,
12790 El Camino Real, San Diego, California 92130
(“Neurocrine”).
WHEREAS ,
DOV and Neurocrine have entered into a Consent and Agreement dated
December 13, 2002 (“2002 Agreement”) pursuant to
which certain provisions of the Sublicense Agreement were
amended.
WHEREAS ,
DOV and Neurocrine entered into a Consent Agreement and Amendment
dated February 25, 2004 (“2004 Agreement”)
pursuant to which certain provisions of the Sublicense Agreement
were amended.
WHEREAS ,
DOV and Neurocrine would now like to amend the Sublicense Agreement
as amended by the 2002 Agreement and the 2004 Agreement (the
“Amended Sublicense Agreement”) and the 2002 Agreement
and 2004 Agreement.
NOW, THEREFORE ,
in consideration of the foregoing premises and the promises, mutual
covenants and obligations set forth below, the parties agree as
follows:
1. Amendment of Section 3.1 of 2002 Agreement.
Section 3.1
of the 2002 Agreement is hereby revised to delete the following
sentence:
“Any
such sublicense shall require the prior written approval of
each of DOV and ACY...(each an “Approved
Sublicensee”).
In
place of the deleted sentence the following shall be
added:
“Each
sublicensee of Neurocrine shall be deemed an approved
sublicensee (each an “Approved
Sublicensee”).”
2. Amendment of Section 4.2 of the Sublicense Agreement and
Section 3.3 of the 2004 Agreement.
(a) Section 4.2 of the Sublicense Agreement is hereby
amended to delete the following milestone:
“U.S.
$3,000,000 upon regulatory approval for the marketing of the
Marketed Product within either the United States, Japan or
within the EU.”
The
following new milestone is hereby added.
“U.S.
$2,000,000 on November 1, 2007. U.S. $1,000,000 upon the
regulatory approval for the marketing of the Marketed Product
within either the United States, Japan or within the
EU.
***Text Omitted and Filed Separately with the Securities and
Exchange
Commission. Confidential Treatment Requested
Under
17 C.F.R. Sections 200.80(b)(4) and
240.24b-2
(b) Section 3.3
of the 2004 Agreement (amending Section 6.2 of the
License Agreement, as amended and supplemented in full) is
hereby amended to delete the following:
“U.S.
$1,500,000 upon regulatory approval for the marketing of the
Marketed Product within either the United States, Japan or
within the EU.”
The
following new milestone is hereby added.
“U.S.
$1,000,000 on November 1, 2007. U.S. $500,000 upon the
regulatory approval for the marketing of the Marketed Product
within either the United States, Japan or within the
EU”
The
parties acknowledge that pursuant to the 2004 Agreement, all
payments by Neurocrine to DOV under clause (a) are net of
payments set forth in such Section 3.3 of the 2004
Agreement. For clarity, such U.S. $2,000,000 clause
(a) payment is hereby owed and accrued to DOV and due and
payable, is not contingent on any event, and is payable
without any set-off, credit or deduction (other than the one
million dollar $1,000,000 payment to Neurocrine set forth in
such Section 3.3 of the 2004 Agreement).
3. Royalty Prepayment.
(a)
Definitions .
Capitalized terms used herein and not otherwise defined will have
the definition set forth in the Amended Sublicense
Agreement.
“FDA
Approval” shall mean approval by the United States Food
and Drug Administration of the NDA for IR Product originally
filed with the FDA on June 12, 2007 with
[...***...].
“First
Commercial Sale” shall mean with respect to the IR
Product, after it is approved, commercial sale by Neurocrine,
any of its Affiliates and/or its sublicensees of the IR
Product in its commercial form to a third party in exchange
for cash or some equivalent to which value can be assigned.
Transfer of IR Product between or among Neurocrine, its
Affiliates and sublicensees will not constitute commercial
sales.
“Indiplon”
shall mean
N-methyl-N-(3-{3-[2-thienylcarbonyl]-pyrazolo-[1,5-a]-pyrimidin-7-yl}phenyl)
acetamide.
“IR
Product” shall mean the immediate release capsule of
Indiplon.
[...***...]
“U.S.
Sublicense” shall mean Neurocrine shall have entered
into an
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