AMENDMENT
Exhibit 10.58
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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. 000 Xxxxxx Xx., Xxxxxxxx, XX 00000 (“DOV”) and Neurocrine
Biosciences, Inc., 00000 Xx Xxxxxx Xxxx, Xxx Xxxxx, Xxxxxxxxxx 00000
(“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.
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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 effective agreement
providing for a sublicense of any of Indiplon development and commercialization
rights under the Amended Sublicense Agreement in the United States territory
with a biotechnology or pharmaceutical company.
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(b)
Royalty
Prepayment.
Upon
DOV’s election, Neurocrine will pay DOV [...***...] as a prepayment (“Royalty
Prepayment”) of the royalty payable to DOV pursuant to the Amended Sublicense
Agreement, this Amendment, the 2002 Agreement and the 2004 Agreement (the
“Royalty”), as provided below. Each Prepayment will be at DOV’s option upon each
of the first and second occurrence of the events set forth below
(“Events”).
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Events
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Royalty
Prepayment to DOV
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First
to occur
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Any
of:
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(i)
FDA Approval,
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(ii)
US Sublicense, or
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(iii)
First Commercial Sale
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[...***...]
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Second
to occur
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Any
of:
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(i)
FDA Approval,
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(ii)
US Sublicense, or
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(iii)
First Commercial Sale
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[...***...]
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DOV
may
elect to receive each Royalty Prepayment upon written notice to Neurocrine
within thirty (30) days of the specified first to occur and second to occur
Event, in which case Neurocrine shall wire the Royalty Prepayment to an account
designated by DOV within five(5) business days, without any set-off, credit
or
deduction. Upon expiration of this thirty (30) day period, the option to
receive the Royalty Prepayment will lapse and DOV will have deemed to waive
their right to receive any future Royalty Prepayments; provided that such 30-day
period will not lapse until thirty (30) days after Neurocrine has notified
DOV
in writing of the occurrence of an Event. If a Royalty Prepayment is made to
DOV
such Royalty Prepayment would be non-refundable to Neurocrine; the parties
acknowledge and agree that the only obligation to repay any Royalty Prepayment
will be from the Royalty otherwise payable to DOV under the Amended Sublicense
Agreement, this Amendment, the 2002 Agreement and the 2004 Agreement, and that
if any such Royalty Prepayment is not fully repaid by the Royalty for whatever
reason, there will be no obligation to repay same. DOV acknowledges that this
Royalty Prepayment is potentially for multiple years of Royalty that would
otherwise be payable to DOV.
DOV
further agrees that the Royalty to be credited against the Royalty Prepayment
will be discounted at a [...***...] Royalty Prepayment until such time as the
first Royalty Prepayment balance is zero.
In
the
event of a second [...***...] Royalty Prepayment, the Royalty to be credited
against the Royalty Prepayment will be discounted at a [...***...] Royalty
Prepayment until such time as the second Royalty Prepayment balance is
zero.
In
the
event that [...***...] Royalty Prepayments are made, the Royalty credited
against the first Royalty Prepayment will be exhausted [...***...] prior to
crediting of Royalties
***
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against
the second Royalty Prepayment [...***...]. The actual Royalty earned for each
quarterly period will not be paid to DOV, but instead will be credited against
the unused balance of the Royalty Prepayment until such time that the balance
of
the Royalty Prepayment is reduced to zero. At the point the Royalty Prepayment
is reduced to zero, cash Royalty payments to DOV will commence as described
in
the Amended Sublicense Agreement.
For
clarity an example is provided on Exhibit A.
Neurocrine
hereby represents and warrants to DOV that the NDA presently under examination
by the FDA was filed on June 12, 2007, is for immediate release capsule of
Indiplon, [...***...].
4.
Royalty Sale. Neurocrine
will, and hereby does upon DOV’s notice and request, permit DOV (i) to
assign the Royalty and audit rights (Section 5.5) under the Amended
Sublicense Agreement, this Amendment, the 2002 Agreement and the 2004 Agreement,
(ii) to share the Royalty reports delivered thereunder pursuant to
commercially reasonable confidentiality provisions, and (iii) to direct
payment of the Royalty to any third party (including a financial institution
as
part of a “lock-box” arrangement), optionally on an irrevocable basis, all of
the foregoing
in connection with a monetization of the Royalty by DOV. Neurocrine will confirm
same in connection with any such monetization at DOV’s request. Otherwise, all
other rights under the Amended Sublicense Agreement will be assignable only
in
compliance with such Section 11 and elsewhere thereunder.
5.
Miscellaneous.
a.
Counterparts.
This
Amendment may be executed in any number of counterparts each of which shall
be
original and all originals of which shall be deemed a single
instrument.
b.
Governing Law.
This
Amendment will be governed and construed by the substantive laws of the State
of
New York.
c.
Rights of Approved Sublicensees.
The
parties hereby agree that the Approved Sublicensees (as such definition is
amended hereunder) have the rights specified under Section 4.7 of the 2002
Agreement.
d.
Entire Agreement.
The
Amended Sublicense Agreement, this Amendment, the 2002 Agreement and the 2004
Agreement are the full understanding of the parties with respect to the subject
matter hereof. Each party confirms, to its knowledge as of the date first
written above, that the other party is not in default of any such agreements,
and that such party does not have any damages claims against such other party
hereunder or thereunder.
IN
WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed
by
their duly authorized representatives.
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***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
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NEUROCRINE
BIOSCIENCES, INC.
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/s/
Xxxx X. Xxxxx
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By:
Xxxx X. Xxxxx
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Title:
President and Chief Executive Officer
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DOV
PHARMACEUTICAL, INC.
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/s/
Xxxxxxx Xxxxxx
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By:
Xxxxxxx Xxxxxx
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Title:
Chief Executive Officer
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Confidential Treatment Requested Under
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C.F.R. Sections 200.80(b)(4) and 240.24b-2
EXHIBIT
A
[...***...]
***
Confidential Treatment Requested
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