AMENDMENT
Exhibit 10.27
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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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(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”).
| Events | Royalty Prepayment to DOV | |||
First to occur
|
Any of: | |||
| (i) FDA Approval, | ||||
| (ii) US Sublicense, or | ||||
| (iii) First Commercial Sale | [...***...] | |||
Second to occur
|
Any of: | |||
| (i) FDA Approval, | ||||
| (ii) US Sublicense, or | ||||
| (iii) First Commercial Sale | [...***...] |
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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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
NEUROCRINE BIOSCIENCES, INC. |
||
/s/ Xxxx X. Xxxxx |
||
Title: President and Chief Executive Officer |
||
DOV PHARMACEUTICAL, INC. |
||
/s/ Xxxxxxx Xxxxxx |
||
Title: Chief Executive Officer |
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EXHIBIT A
[...***...]
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