EXHIBIT 10.1
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASSIGNMENT AND LICENSE AGREEMENT
BY AND BETWEEN
WYETH HOLDINGS CORPORATION
AND
NEUROCRINE BIOSCIENCES, INC.
FEBRUARY 26, 2004
TABLE OF CONTENTS
PAGE
----
1. DEFINITIONS............................................................... 2
1.1 "Affiliate"......................................................... 2
1.2 "Amended and Restated License Agreement"............................ 2
1.3 "Assignment and Assumption Agreement"............................... 2
1.4 "Closing"........................................................... 2
1.5 "Closing Date"...................................................... 2
1.6 "Compound".......................................................... 2
1.7 "Compound License Agreement"........................................ 2
1.8 "Compound Patent"................................................... 3
1.9 "Confidential Information".......................................... 3
1.10 "Control" or "Controlled"........................................... 3
1.11 "Effective Date".................................................... 3
1.12 "HSR Act"........................................................... 3
1.13 "HSR Filing"........................................................ 3
1.14 "HSR Clearance Date"................................................ 3
1.15 "Neurocrine Sublicense Agreement"................................... 3
1.16 "Original License Agreement"........................................ 3
1.17 "Pfizer Collaboration Agreement".................................... 4
1.18 "Pfizer Sublicense Agreement"....................................... 4
1.19 "Share Price"....................................................... 4
1.20 "Stock Purchase Agreement".......................................... 4
1.21 "Territory"......................................................... 4
1.22 "Third Party"....................................................... 4
1.23 "Wyeth Intellectual Property"....................................... 4
1.24 "2002 Consent Agreement"............................................ 4
1.25 "2004 Consent Agreement"............................................ 4
2. ASSIGNMENT OF RIGHTS...................................................... 5
2.1 Assignment.......................................................... 5
2.2 Assumption.......................................................... 5
2.3 No Continuing Obligations........................................... 5
Assignment and Assumption Agreement.......................................... 6
3. LICENSES.................................................................. 6
3.1 Exclusive License................................................... 6
3.2 Retained Rights; No Implied Licenses................................ 6
3.3 Sublicensing........................................................ 6
3.4 Section 365(n) of the Bankruptcy Code............................... 7
4. CONSIDERATION............................................................. 7
4.1 Cash Payments....................................................... 7
4.2 Equity Payment...................................................... 7
4.3 No Other Payments................................................... 8
4.4 Taxes and Withholding............................................... 8
Page i
5. THE CLOSING............................................................... 8
5.1 Closing Date........................................................ 8
5.2 Deliveries by Neurocrine............................................ 8
5.3 Deliveries by Wyeth................................................. 9
6. CONDITIONS and covenants.................................................. 10
6.1 Conditions to Obligations of Each Party............................. 10
6.2 Conditions to Obligations of Wyeth.................................. 10
6.3 Conditions to Obligations of Neurocrine............................. 11
6.4 Covenants........................................................... 11
7. REPRESENTATIONS AND WARRANTIES............................................ 11
7.1 Representations and Warranties of Each Party........................ 11
7.2 Additional Representations and Warranties of Wyeth.................. 12
7.3 Additional Representations and Warranties by Neurocrine............. 14
7.4 Representation by Legal Counsel..................................... 15
7.5 No Inconsistent Agreements.......................................... 15
8. CONFIDENTIALITY........................................................... 15
8.1 Non-Disclosure and Use Restrictions................................. 15
8.2 SEC Filings......................................................... 16
8.3 Public Statements................................................... 16
9. TERM AND TERMINATION...................................................... 16
9.1 Government Approvals................................................ 16
9.1.1 HSR Filing.................................................... 16
9.1.2 Other Government Approvals.................................... 17
9.2 Termination by Mutual Agreement..................................... 17
9.3 Termination for Cause............................................... 17
9.4 Effects of Termination.............................................. 17
10. INDEMNIFICATION AND INSURANCE............................................. 18
10.1 Indemnification by Neurocrine....................................... 18
10.2 Indemnification by Wyeth............................................ 19
10.3 Procedure........................................................... 19
10.4 Insurance........................................................... 20
10.5 Limitation.......................................................... 20
11. MISCELLANEOUS............................................................. 20
11.1 Assignment.......................................................... 20
11.2 Further Actions..................................................... 21
11.3 Notices............................................................. 21
11.4 Amendment........................................................... 22
11.5 Waiver.............................................................. 22
11.6 Severability........................................................ 22
11.7 Descriptive Headings................................................ 22
11.8 Governing Law; Dispute Resolution................................... 22
11.9 Entire Agreement of the Parties..................................... 23
11.10 Independent Contractors.......................................... 23
11.11 Counterparts..................................................... 24
Exhibit 1.7 Form of Compound License Agreement
Page ii
Exhibit 1.20 Form of Stock Purchase Agreement
Exhibit 1.23 Wyeth Patents
Exhibit 2.1 Form of Assignment and Assumption Agreement
Exhibit 2.4 Form of Patent Assignment
Exhibit 8.3 Press Release
Page iii
ASSIGNMENT AND LICENSE AGREEMENT
This Assignment and License Agreement (the "Agreement") is entered into
on this 26th day of February, 2004 (the "Signature Date") by and between Wyeth
Holdings Corporation (formerly known as "American Cyanamid Company"), a Maine
corporation, having a place of business at 5 Giralda Farms, Madison, New Jersey
07940 (hereinafter "Wyeth") and Neurocrine Biosciences, Inc., a Delaware
corporation, having a place of business at 10555 Science Center Drive, San
Diego, California 92121 (hereinafter, "Neurocrine"). Wyeth and Neurocrine may
each be referred to herein individually as a "Party" and collectively as the
"Parties".
WHEREAS, Wyeth and DOV Pharmaceutical, Inc. (hereinafter "DOV") entered
into that certain license agreement, dated May 28, 1998 (hereinafter, the
"Original License Agreement"), pursuant to which Wyeth, inter alia, granted to
DOV an exclusive license, under certain patent rights and know-how, with respect
to several compounds, including the Compound (as defined below);
WHEREAS, DOV and Neurocrine entered into a Sublicense and Development
Agreement dated June 30, 1998 (as amended from time to time, the "Neurocrine
Sublicense Agreement"), pursuant to which DOV sublicensed to Neurocrine the
rights relating to the Compound licensed to DOV under the Original License
Agreement;
WHEREAS, Neurocrine and Pfizer, Inc. (hereinafter, "Pfizer") entered
into (i) that certain license agreement dated December 18, 2002 (as amended from
time to time, the "Pfizer Sublicense Agreement") pursuant to which Neurocrine,
inter alia, sublicensed to Pfizer the rights relating to the Compound licensed
to Neurocrine under the Neurocrine Sublicense Agreement and (ii) that certain
collaboration agreement dated December 18, 2002 (as amended from time to time,
the "Pfizer Collaboration Agreement") pursuant to which Neurocrine and Pfizer,
inter alia, will copromote the Compound in the United States;
WHEREAS, Wyeth, DOV and Neurocrine entered into that certain Consent
and Agreement dated December 13, 2002 (the "2002 Consent Agreement") in order to
facilitate the grant by Neurocrine to Pfizer of certain rights under the Pfizer
Sublicense Agreement;
WHEREAS, Neurocrine now desires to obtain from Wyeth and Wyeth now
desires to grant to Neurocrine: (i) an assignment of (x) all of Wyeth's rights
and obligations under the Compound License Agreement (as defined below), and (y)
Wyeth's rights and obligations under the 2002 Consent Agreement to the extent
such rights and obligations relate to the Compound and (z) the Compound Patent
(as defined below) and (ii) an exclusive license under the Wyeth Intellectual
Property (as defined below), to make, have made, use and sell the Compound
(which license rights are subject to the rights and licenses granted to DOV
under the Compound License Agreement);
Page 1 of 24
WHEREAS, on or before the Closing (as defined below), Wyeth and DOV
will enter into: (i) an amended and restated license agreement, pursuant to
which the Original License Agreement will be amended to delete therefrom all
rights and obligations of each of Wyeth and DOV with respect to the Compound
(the "Amended and Restated License Agreement"), and (ii) the Compound License
Agreement, setting forth the rights and obligations of each of Wyeth and DOV
solely as they relate to the Compound; and
WHEREAS, Wyeth, DOV and Neurocrine entered into that certain Consent
Agreement and Amendment, dated February 25, 2004 (the "2004 Consent Agreement")
pursuant to which, inter alia, DOV has provided its consent for Wyeth to enter
into and perform this Agreement.
NOW THEREFORE, in consideration of the foregoing premises and the
promises, mutual covenants and obligations set forth below, and other good and
valuable consideration, the Parties agree as follows:
1. DEFINITIONS.
1.1 "AFFILIATE" shall mean, with respect to any person or entity,
any other person or entity which controls, is controlled by or
is under common control with such person or entity. A person
or entity shall be regarded as in control of another entity if
it owns or controls at least fifty percent (50%) of the equity
securities of the subject entity entitled to vote in the
election of directors (or, in the case of an entity that is
not a corporation, for the election of the corresponding
managing authority), provided, however, that the term
"Affiliate" shall not include subsidiaries or other entities
in which a Party or its Affiliates owns a majority of the
ordinary voting power necessary to elect a majority of the
board of directors or other governing board, but is restricted
from electing such majority by contract or otherwise, until
such time as such restrictions are no longer in effect.
1.2 "AMENDED AND RESTATED LICENSE AGREEMENT" shall have the
meaning set forth in the preamble of this Agreement.
1.3 "ASSIGNMENT AND ASSUMPTION AGREEMENT" shall have the meaning
set forth in Section 2.1 hereof.
1.4 "CLOSING" shall have the meaning set forth in Section 5.1
hereof.
1.5 "CLOSING DATE" shall have the meaning set forth in Section 5.1
hereof.
1.6 "COMPOUND" shall mean the chemical compound identified in the
License Agreement as CL 285,489, which compound is also known
as indiplon.
1.7 "COMPOUND LICENSE AGREEMENT" shall mean the license agreement
Page 2 of 24
relating solely to the Compound, which license agreement is to
be entered into by and between Wyeth and DOV upon their
amendment and restatement of the Original License Agreement as
described above in the preamble to this Agreement. The
Compound License Agreement shall be in the form attached
hereto as Exhibit 1.7.
1.8 "COMPOUND PATENT" shall mean United States Patent 6,399,621
granted on June 4, 2002, which patent claims the Compound.
1.9 "CONFIDENTIAL INFORMATION" shall mean, with respect to a
Party, all non-public proprietary data or information that is
disclosed by such Party to the other Party in connection with
this Agreement or information designated as "Confidential
Information" of such Party hereunder.
1.10 "CONTROL" OR "CONTROLLED" shall mean, with respect to any (a)
item of information or know-how, or (b) intellectual property
right, the possession (whether by ownership or license, other
than pursuant to this Agreement) by a Party of the ability to
grant to the other Party access and/or a license as provided
herein under such item or right without violating the terms of
any agreement with any Third Party existing as of the date
such Party is obligated under this Agreement to grant such
access and/or license.
1.11 "EFFECTIVE DATE" shall mean, upon completion of the Closing,
the Closing Date.
1.12 "HSR ACT" shall mean the Hart-Scott-Rodino Antitrust
Improvements Act of 1976, as amended, and the rules and
regulations promulgated thereunder.
1.13 "HSR FILING" shall mean filings by Wyeth and Neurocrine with
the United States Federal Trade Commission and the Antitrust
Division of the United States Department of Justice of a
Notification and Report Form for Certain Mergers and
Acquisitions (as that term is defined in the HSR Act) with
respect to the matters set forth in this Agreement and in the
Stock Purchase Agreement, as applicable, together with all
required documentary attachments thereto.
1.14 "HSR CLEARANCE DATE" shall mean the earliest date on which the
Parties have actual knowledge that all applicable waiting
periods under the HSR Act with respect to the transactions
contemplated hereunder have expired or have been terminated.
1.15 "NEUROCRINE SUBLICENSE AGREEMENT" shall have the meaning set
forth above in the preamble of this Agreement.
1.16 "ORIGINAL LICENSE AGREEMENT" shall have the meaning set forth
above in
Page 3 of 24
the preamble of this Agreement.
1.17 "PFIZER COLLABORATION AGREEMENT" shall have the meaning set
forth above in the preamble of this Agreement.
1.18 "PFIZER SUBLICENSE AGREEMENT" shall have the meaning set forth
above in the preamble of this Agreement.
1.19 "SHARE PRICE" shall mean the price per share for common stock
of Neurocrine calculated in accordance with the Stock Purchase
Agreement.
1.20 "STOCK PURCHASE AGREEMENT" shall mean that certain stock
purchase agreement to be entered into by Neurocrine and Wyeth
(or one of Wyeth's Affiliates designated by Wyeth) on the
Closing Date, which agreement shall be in the form attached
hereto as Exhibit 1.20.
1.21 "TERRITORY" shall mean all countries of the world.
1.22 "THIRD PARTY" shall mean any person or entity other than
Wyeth, Neurocrine or any of their respective Affiliates.
1.23 "WYETH INTELLECTUAL PROPERTY" shall mean (a) that Wyeth
know-how consisting of all information, patentable or
otherwise, developed, applied, or acquired by Wyeth as of
[***] relating to the production or development of the
Compound, which information is reasonably useful or necessary
to develop or manufacture the Compound and (b) those patents
and patent applications Controlled by Wyeth that claim the
Compound or the manufacture or use thereof, which patents and
patent applications are listed on Exhibit 1.23 attached
hereto, and including all continuations,
continuations-in-part, divisionals, re-issues,
re-examinations, extensions, substitutions, patents of
addition, and supplementary certificates (or equivalents
thereof) of any such patents and patent applications and all
foreign counterparts thereof, in each case, only to the extent
that they claim or would otherwise be infringed by the
manufacture, use or sale of the Compound, provided, however,
that the Wyeth Intellectual Property shall not include the
Compound Patent. [***]
1.24 "2002 CONSENT AGREEMENT" shall have the meaning set forth in
the preamble of this Agreement.
1.25 "2004 CONSENT AGREEMENT" shall have the meaning set forth in
the preamble of this Agreement.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 4 of 24
2. ASSIGNMENT OF RIGHTS.
2.1 ASSIGNMENT. Subject to the terms and conditions set forth in
this Agreement, and in consideration for the payment to be
made by Neurocrine to Wyeth under Section 4.1 hereof and the
transactions contemplated by the Stock Purchase Agreement in
accordance with Section 4.2 hereof, Wyeth hereby agrees to
assign, and shall assign at the Closing, to Neurocrine: (i)
all of Wyeth's rights and obligations under the Compound
License Agreement, and (ii) Wyeth's rights and obligations
under the 2002 Consent Agreement only to the extent such
rights and obligations relate to the Compound, and (iii) all
of Wyeth's right, title and interest in and to the Compound
Patent (all of which rights being so assigned are subject to
the rights and licenses granted to DOV under the Compound
License Agreement and granted to Neurocrine, DOV and
Neurocrine's sublicensee under the 2002 Consent Agreement).
Such assignments shall be contingent upon and become effective
only upon completion of the Closing and shall be made pursuant
to the Assignment and Assumption Agreement substantially in
the form attached hereto as Exhibit 2.1, to be executed and
delivered by the Parties and DOV at the Closing (the
"Assignment and Assumption Agreement").
2.2 ASSUMPTION. Subject to the terms and conditions set forth in
this Agreement, Neurocrine hereby agrees to assume: (i) all of
Wyeth's rights and obligations under the Compound License
Agreement, and (ii) Wyeth's rights and obligations under the
2002 Consent Agreement only to the extent such rights and
obligations relate to the Compound. Additionally, Neurocrine
as of the Closing and thereafter shall have the sole and
exclusive right, at its own expense, for the continued
maintenance and enforcement of the Compound Patent, subject
only to the obligations so assumed by Neurocrine and the
rights and licenses granted to DOV under the Compound License
Agreement. Neurocrine's assumption of such rights and
obligations shall be contingent upon and become effective only
upon completion of the Closing and shall be made pursuant to
the Assignment and Assumption Agreement.
2.3 NO CONTINUING OBLIGATIONS. Neurocrine agrees that, upon
completion of the Closing and thereafter, Wyeth shall have no
further or continuing rights or obligations (a) with respect
to the Compound Patent, (b) under the Compound License
Agreement, or (c) under the 2002 Consent Agreement, to the
extent that any such obligations relate solely to the
Compound. Notwithstanding the foregoing, Wyeth agrees that it
will at all times remain obligated under the 2002 Consent
Agreement as and only to the extent that Wyeth is and remains
the owner and licensor (to Neurocrine, DOV or Neurocrine's
Approved Sublicensee) of the Wyeth Know-How and Wyeth Patents
(as such terms are defined in the Compound License Agreement,
but not including the Compound Patent).
Page 5 of 24
2.4 ASSIGNMENT AND ASSUMPTION AGREEMENT. On the Effective Date or
such later date as may be mutually agreed to by the Parties,
Wyeth, after having received the payment due from Neurocrine
under Section 4.1 and the shares of Neurocrine common stock
and payments to be transferred and delivered to Wyeth in
accordance with Section 4.2 hereof and the Stock Purchase
Agreement, shall execute and deliver to Neurocrine the
Assignment and Assumption Agreement. Additionally, at such
time, Wyeth shall execute and deliver to Neurocrine the Patent
Assignment, substantially in the form attached hereto as
Exhibit 2.4 (the "Patent Assignment") and such other documents
that Neurocrine may reasonably require in order to record the
assignment to Neurocrine of the Compound Patent in the U.S.
Patent Office and/or any foreign patent office and to record
the assignment to Neurocrine of the Compound License Agreement
and/or the 2002 Consent Agreement in any governmental office
and/or as otherwise necessary or useful to perfect the rights
being assigned to Neurocrine hereunder.
3. LICENSES.
3.1 EXCLUSIVE LICENSE. Effective as of, and only upon, the
completion of the Closing, Wyeth hereby grants to Neurocrine
an exclusive, fully-paid, royalty free, perpetual, irrevocable
license under the Wyeth Intellectual Property, solely to make,
have made, use, import, offer for sale and/or sell
pharmaceutical products containing the Compound in the
Territory subject to the licenses granted to DOV pursuant to
the Compound License Agreement.
3.2 RETAINED RIGHTS; NO IMPLIED LICENSES. Except for the license
expressly granted to Neurocrine in Section 3.1 above, Wyeth
retains all right, title and interest under the Wyeth
Intellectual Property and shall have the right to practice and
use the Wyeth Intellectual Property for any purpose without
any obligation to Neurocrine, subject to the rights and
licenses granted by Wyeth to DOV under the Compound License
Agreement and by Wyeth to DOV, Neurocrine and/or Neurocrine's
sublicensee under the 2002 Consent Agreement. The Parties
expressly agree that, under this Agreement, Neurocrine shall
have no right, title or interest, either express or implied,
in or to any patent, patent application or other intellectual
property right owned or controlled by Wyeth or any of Wyeth's
Affiliates, except for the license rights expressly granted in
Section 3.1 above.
3.3 SUBLICENSING. Subject to and to the extent not in
contravention of the rights and licenses granted to DOV under
the Compound License Agreement, Neurocrine may grant to one or
more Third Parties sublicenses of the rights granted to it
under Section 3.1 hereof at any time. Each such sublicense
shall be subject and subordinate to, and consistent with, the
terms and conditions of this Agreement, and shall provide that
any such sublicensee shall not further sublicense except on
terms
Page 6 of 24
consistent with this Section 3.3. Neurocrine shall provide
Wyeth with a copy of any sublicense granted pursuant to this
Section 3.3 within thirty (30) days after the execution
thereof. Neurocrine shall remain responsible for the
performance of its sublicensees, and shall ensure that any
such sublicensees comply with the relevant provisions of this
Agreement.
3.4 SECTION 365(n) OF THE BANKRUPTCY CODE. All rights and licenses
granted under or pursuant to any Section of this Agreement
are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the Bankruptcy Code, licenses of rights to
"intellectual property" as defined under Section 101 (35A) of
the Bankruptcy Code. The Parties shall retain and may fully
exercise all of their respective rights and elections under
the Bankruptcy Code.
4. CONSIDERATION.
4.1 CASH PAYMENTS. In partial consideration for the rights and
obligations assigned to Neurocrine under Article 2 hereof and
the licenses granted to Neurocrine under Article 3 hereof, and
subject to the terms and conditions of this Agreement,
Neurocrine shall pay to Wyeth :
(a) the non-creditable sum of Five Million Dollars
($5,000,000.00) (the "Initial Fee"), which amount
shall be payable within two (2) business days of the
Signature Date and shall be non-refundable except as
otherwise expressly set forth in Section 9.4 hereof;
and
(b) the non-refundable, non-creditable sum of Forty-Five
Million Dollars ($45,000,000.00) which amount shall
be payable at the Closing.
Such payments shall be made in United States Dollars by wire
transfer of immediately available funds to a bank account of
Wyeth or one of Wyeth's Affiliates, which bank account is
designated in writing by Wyeth to Neurocrine.
4.2 EQUITY PAYMENT. In further consideration for the rights and
obligations assigned to Neurocrine under Article 2 hereof and
the licenses granted to Neurocrine under Article 3 hereof,
Neurocrine, at the Closing and in accordance with the terms
and conditions of the Stock Purchase Agreement, shall
irrevocably transfer and deliver to Wyeth or, at Wyeth's
election, one of Wyeth's Affiliates, (i) that number of shares
of Neurocrine common stock that, based on the Share Price, has
a value of Forty-Five Million Dollars ($45,000,000.00), as
such amount may be adjusted in accordance with the terms and
conditions of the Stock Purchase Agreement and (ii) if
applicable, that amount of cash which may be due in accordance
with the terms and conditions of the Stock Purchase Agreement
as a result of any adjustment made to the number of shares of
Page 7 of 24
Neurocrine common stock to be transferred and delivered to
Wyeth pursuant to the Stock Purchase Agreement.
4.3 NO OTHER PAYMENTS. Upon receipt by Wyeth of the payment
required under Section 4.1 above and the Neurocrine common
stock to be delivered to Wyeth in accordance with Section 4.2
above and the terms and conditions of the Stock Purchase
Agreement, Neurocrine, except as provided in Article 10 below,
shall have no further obligation to make any payments to Wyeth
in connection with the assignment of rights and obligations
hereunder, the grant of licenses to Neurocrine hereunder
and/or the development and/or commercialization of the
Compound or pharmaceutical products containing the Compound,
and the licenses granted to Neurocrine under Section 3.1 shall
thereafter be fully paid up and royalty free.
4.4 TAXES AND WITHHOLDING. All payments under this Agreement will
be made without any deduction or withholding for or on account
of any tax unless such deduction or withholding is required by
applicable laws or regulations. If Neurocrine is so required
to deduct or withhold, Neurocrine will (a) promptly notify
Wyeth of such requirement, (b) pay to the relevant authorities
the full amount required to be deducted or withheld promptly
upon the earlier of determining that such deduction or
withholding is required or receiving notice that such amount
has been assessed against Wyeth, and (c) promptly forward to
Wyeth an official receipt (or certified copy) or other
documentation reasonably acceptable to Wyeth evidencing such
payment to such authorities.
5. THE CLOSING.
5.1 CLOSING DATE. Unless this Agreement shall have been earlier
terminated, the closing of the transactions contemplated
hereby (the "Closing") shall take place at the offices of
Wyeth Pharmaceuticals, 500 Arcola Road, Collegeville,
Pennsylvania 19426 on the later of March 15, 2004 or the
second business day after the date on which the last to be
fulfilled or waived of the conditions set forth in Article 6
shall be fulfilled or waived in accordance with this Agreement
or at such other time, date or place as the Parties may
mutually agree upon in writing (the "Closing Date"). At the
Closing, the Parties will exchange funds, certificates and
other documents specified in this Agreement. For purposes of
this Agreement, the Closing will be treated as if it occurred
at 11:59 p.m. EST on the Closing Date.
5.2 DELIVERIES BY NEUROCRINE. On the Closing Date, Neurocrine
shall deliver to Wyeth the following:
(a) the Stock Purchase Agreement duly executed by
Neurocrine;
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(b) the payment due to Wyeth under Section 4.1(b) of this
Agreement;
(c) a stock certificate representing the number of shares
of Neurocrine common stock to be delivered to Wyeth
or Wyeth's Affiliate pursuant to the Stock Purchase
Agreement and Section 4.2 above;
(d) all payments that may be required to be paid by
Neurocrine to Wyeth under the Stock Purchase
Agreement in connection with any adjustment to be
made to the number of shares of Neurocrine common
stock to be transferred and delivered to Wyeth
thereunder;
(e) the Assignment and Assumption Agreement duly signed
by an authorized officer of Neurocrine and such other
instruments of assumption and other certificates,
instruments or documents, in form and substance
reasonably acceptable to Wyeth and Neurocrine, as may
be required under this Agreement or as may otherwise
be necessary to effect Neurocrine's assumption under
applicable laws of the rights and obligations and
other assets being assigned and/or licensed to
Neurocrine under this Agreement;
(f) such other instruments and documents, in form and
substance reasonably acceptable to Wyeth and
Neurocrine, as may be necessary to effect the
Closing; and
(g) a certificate, executed by an authorized officer of
Neurocrine, certifying (i) the due organization and
good standing of Neurocrine, and (ii) the authority
and incumbency of officers of Neurocrine executing
this Agreement and the other agreements, instruments
and certificates delivered by Neurocrine to Wyeth
upon the Closing.
5.3 DELIVERIES BY WYETH. On the Closing Date, Wyeth shall deliver
to Neurocrine the following:
(a) the Stock Purchase Agreement duly executed by Wyeth
(or an Affiliate of Wyeth designated by Wyeth);
(b) the Assignment and Assumption Agreement duly executed
by an authorized officer of Wyeth, and any other
appropriate instruments of assignment, sale,
conveyance or transfer, in form and substance
reasonably acceptable to Wyeth and Neurocrine, as may
be required under this Agreement or as may otherwise
be necessary to effect Wyeth's assignment under
applicable laws of the rights and obligations and
other assets being assigned and/or licensed to
Neurocrine under this Agreement;
Page 9 of 24
(c) the Patent Assignment duly executed by an authorized
officer of Wyeth;
(d) such other instruments and documents, in form and
substance reasonably acceptable to Wyeth and
Neurocrine, as may be necessary to effect the
Closing; and
(e) a certificate, executed by an authorized officer of
Wyeth, certifying (i) the due organization and good
standing of Wyeth, and (ii) the authority and
incumbency of officers of Wyeth executing this
Agreement and the other agreements, instruments and
certificates delivered by Wyeth to Neurocrine upon
the Closing.
6. CONDITIONS AND COVENANTS.
6.1 CONDITIONS TO OBLIGATIONS OF EACH PARTY. The obligation of
each Party to enter into and effect the transactions
contemplated by this Agreement shall be subject to the
fulfillment at or prior to the Closing Date of the following
conditions:
(a) all consents and approvals of governmental
authorities, if any, necessary to permit the
consummation of the transactions contemplated by this
Agreement shall have been obtained and any waiting
period (including any extension thereof) applicable
to the consummation of this Agreement under the HSR
Act shall have expired or been terminated; and
(b) no preliminary or permanent injunction or other
order, decree or ruling issued by a court of
competent jurisdiction or by a governmental authority
or executive order promulgated or enacted by any
governmental authority shall be in effect that would
restrain or otherwise prevent the entry into or the
consummation of the transactions contemplated by this
Agreement.
6.2 CONDITIONS TO OBLIGATIONS OF WYETH. The obligation of Wyeth to
effect the transactions contemplated by Sections 5.1 and 5.3
of this Agreement is subject to the fulfillment at or prior to
the Closing Date of the following conditions:
(a) Neurocrine and DOV shall have duly executed and
delivered the 2004 Consent Agreement which shall be
in full force and effect as of the Closing Date;
(b) Wyeth shall have received all necessary approvals
from its Board of Directors to effect the
transactions contemplated by this Agreement;
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(c) Neurocrine shall have made the payments contemplated
under Section 4.1 hereof, delivered those shares of
Neurocrine common stock and other payments to be
delivered to Wyeth in accordance with the provisions
of the Stock Purchase Agreement and delivered to
Wyeth all other documents and deliverables to be
delivered by Neurocrine to Wyeth at or before the
Closing in accordance with Section 5.2 hereof;
(d) Neurocrine shall have executed and delivered to
Wyeth, the Assignment and Assumption Agreement;
and(c)Neurocrine shall have duly executed and
delivered the Stock Purchase Agreement to be entered
into by the Parties on the Closing Date and shall
have met all other conditions and obligations
required of Neurocrine under the Stock Purchase
Agreement.
6.3 CONDITIONS TO OBLIGATIONS OF NEUROCRINE. The obligation of
Neurocrine to enter into and effect the transactions
contemplated by Sections 5.1 and 5.2 of this Agreement is
subject to the fulfillment at or prior to the Closing Date of
the following conditions:
(a) Wyeth and DOV shall have duly executed and delivered
the Compound License Agreement and the 2004 Consent
Agreement, each of which shall be in full force and
effect as of the Closing Date;
(b) Wyeth shall have executed and delivered to Neurocrine
the Assignment and Assumption Agreement and the
Patent Assignment;
6.4 COVENANTS. Each Party covenants and agrees to use diligent,
good faith efforts to fulfill or cause to be fulfilled each of
the conditions set forth above with respect to its effecting
the transactions contemplated by Article 5 of this Agreement,
at or prior to the Closing Date.
7. REPRESENTATIONS AND WARRANTIES.
7.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each of
Neurocrine and Wyeth hereby represents, warrants, and
covenants to the other Party hereto as follows:
(a) it is a corporation or entity duly organized and
validly existing under the laws of the state or other
jurisdiction of its incorporation or formation;
(b) the execution, delivery and performance of this
Agreement and of the Stock Purchase Agreement by such
Party has been duly authorized by all requisite
corporate action and does not require any shareholder
action or approval, provided, however, that
Page 11 of 24
Neurocrine acknowledges that Wyeth is required to
seek and obtain approval of its Board of Directors in
order to complete the transactions contemplated this
Agreement and that obtaining such approval is a
condition to Wyeth's obligations hereunder;
(c) it has the power and authority to execute and deliver
this Agreement and the Stock Purchase Agreement and
to perform its obligations hereunder and thereunder;
(d) the execution, delivery and performance by such Party
of this Agreement and the Stock Purchase Agreement
and its compliance with the terms and provisions
hereof and thereof does not and will not conflict
with or result in a breach of any of the terms and
provisions of or constitute a default under (i) a
loan agreement, guaranty, financing agreement,
agreement affecting a product or other agreement or
instrument binding or affecting it or its property;
(ii) the provisions of its charter or operative
documents or bylaws; or (iii) any order, writ,
injunction or decree of any court or governmental
authority entered against it or by which any of its
property is bound;
(e) it shall at all times comply with all applicable laws
and regulations relating to its activities under this
Agreement and the Stock Purchase Agreement; and
(f) There is no action, demand, suit, proceeding,
arbitration, grievance, citation, summons, subpoena,
inquiry or investigation of any nature, civil,
criminal, regulatory or otherwise, in law or in
equity, pending or, to such Party's knowledge,
threatened against such Party with respect to this
Agreement, the License Agreement, the 2002 Consent
Agreement or the Compound Patent.
7.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF WYETH. In
addition to the representations and warranties made by Wyeth
in Section 7.1 above and Sections 7.4 and 7.5 below, Wyeth
hereby represents, warrants, and covenants to Neurocrine that
(a) as of the Effective Date of this Agreement, the 2004
Consent Agreement will be in full force and effect
and that, to Wyeth's knowledge, neither Wyeth nor DOV
will have committed any material breach thereunder
which material breach remains uncured and would give
rise to a right of either Neurocrine, Wyeth or DOV to
terminate the 2004 Consent Agreement;
(b) as of the Effective Date of this Agreement, the
Compound License Agreement will be in full force and
effect and that, to Wyeth's knowledge, neither Wyeth
nor DOV will have committed any
Page 12 of 24
material breach thereunder which material breach
remains uncured and would give rise to a right of
either Wyeth or DOV to terminate the Compound License
Agreement; except for the rights and licenses granted
to DOV under the Compound License Agreement and the
rights and licenses granted to Neurocrine and
Neurocrine's sublicensees under the 2002 Consent
Agreement, Wyeth, as of the Effective Date of this
Agreement, will not have granted to any Third Party
any right, title or interest in or to the Compound
Patent or the Wyeth Intellectual Property in so far
as it relates to the Compound;
(c) Except as set forth in (i) the 2002 Consent
Agreement, (ii) the 2004 Consent Agreement, (iii) the
Amended and Restated License Agreement and (iv) the
Compound License Agreement, the Original License
Agreement has not been amended, modified or
supplemented in any way since its effective date,
insofar as it relates to the Compound or the Wyeth
Intellectual Property in so far as it relates to
Compound;
(d) to Wyeth's actual knowledge, without having made or
having any duty to make any inquiry, as of the
Signature Date there is no written safety or other
information in Wyeth's possession relating the
Compound per se, which information (i) has not been
previously disclosed by Wyeth to DOV and/or
Neurocrine, and (ii) in Wyeth's reasonable
determination, would have a material adverse effect
on the development of the Compound;
(e) to Wyeth's actual knowledge, without having made or
having any duty to make any inquiry, as of the
Signature Date, (i) the issued patents within the
Wyeth Intellectual Property and the Compound Patent
are valid and enforceable, (ii) no third party is
infringing any issued patents within the Wyeth
Intellectual Property or the Compound Patent through
the manufacture, use or sale of the Compound and
(iii) no third party owns or controls any patent, or
assuming issuance of the claims as filed therein, any
patent application, which claims the manufacture, use
and sale of Compound per se (for the sake of clarity,
this representation and warranty does not extend to
any pharmaceutical formulation of the Compound or any
general manufacturing or process technology which may
be used by Neurocrine or its sublicensees in
connection with the Compound); and
(f) to Wyeth's actual knowledge, without having made or
having any duty to make any inquiry, as of the
Signature Date there are no patents owned or licensed
by Wyeth or any of its Affiliates that would be
infringed by the making, using or selling the
Compound per se by Neurocrine or its sublicensees,
provided, however, that
Page 13 of 24
this representation and warranty does not and shall
not extend to any patents which may cover Wyeth's
general manufacturing or process technology or
pharmaceutical product formulation technology.
EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 7, WYETH MAKES
NO REPRESENTATION OR WARRANTY OF ANY KIND, EITHER EXPRESS OR
IMPLIED, TO NEUROCRINE, INCLUDING, WITHOUT LIMITATION, ANY
EXPRESS OR IMPLIED WARRANTY WITH RESPECT TO THE COMPOUND, THE
COMPOUND PATENT, THE WYETH INTELLECTUAL PROPERTY, THE
POTENTIAL AMOUNT OF PAYMENTS TO BE RECEIVED BY WYETH FROM DOV
UNDER THE COMPOUND LICENSE AGREEMENT OR WYETH'S OR DOV'S PAST
AND FUTURE PERFORMANCE UNDER THE ORIGINAL LICENSE AGREEMENT,
THE COMPOUND LICENSE AGREEMENT OR THE 2002 CONSENT AGREEMENT.
IN ADDITION TO BUT NOT IN LIMITATION OF THE FOREGOING, AND
EXCEPT AS EXPRESSLY PROVIDED OTHERWISE IN THIS AGREEMENT,
WYETH SPECIFICALLY DISCLAIMS (i) ANY EXPRESS OR IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO THE COMPOUND OR ANY PHARMACEUTICAL
PRODUCT CONTAINING THE COMPOUND, (ii) ANY EXPRESS OR IMPLIED
WARRANTY REGARDING THE TITLE, VALIDITY OR ENFORCEABILITY OF
THE COMPOUND PATENT OR ANY PATENT OR OTHER INTELLECTUAL
PROPERTY RIGHT INCLUDED IN THE WYETH INTELLECTUAL PROPERTY,
AND (iii) ANY EXPRESS OR IMPLIED WARRANTY THAT THE
DEVELOPMENT, MANUFACTURE, USE, DISTRIBUTION, MARKETING,
PROMOTION OR SALE OF THE COMPOUND OR ANY PHARMACEUTICAL
PRODUCT CONTAINING THE COMPOUND BY OR ON BEHALF OF DOV,
NEUROCRINE OR ANY OF THEIR RESPECTIVE LICENSEES OR
SUBLICENSEES WILL NOT INFRINGE ANY PATENT OR OTHER
INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY OR ANY PATENT
OR OTHER INTELLECTUAL PROPERTY OF WYETH OR ANY OF WYETH'S
AFFILIATES, WHICH PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT
IS NOT INCLUDED IN EITHER THE COMPOUND PATENT OR THE WYETH
INTELLECTUAL PROPERTY.
7.3 ADDITIONAL REPRESENTATIONS AND WARRANTIES BY NEUROCRINE. In
addition to the representations and warranties made by
Neurocrine in Section 7.1 above and Sections 7.4 and 7.5
below, Neurocrine hereby represents, warrants, and covenants
to Wyeth that
Page 14 of 24
(a) as of the Effective Date of this Agreement, the 2004
Consent Agreement will be in full force and effect
and that, to Neurocrine's knowledge, neither
Neurocrine nor DOV will have committed any material
breach thereunder which material breach remains
uncured and would give rise to a right of either
Neurocrine, Wyeth or DOV to terminate the 2004
Consent Agreement;
(b) as of the Effective Date of this Agreement it will
have sufficient funds available to fulfill its
payment obligations under this Agreement;
(c) except as set forth in the 2002 Consent Agreement and
the 2004 Consent Agreement, the Neurocrine Sublicense
Agreement has not been amended, modified or
supplemented in any way since its effective date.
7.4 REPRESENTATION BY LEGAL COUNSEL. Each Party hereto represents
that it has been represented by legal counsel in connection
with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the terms
and provisions of this Agreement, the Parties agree that no
presumption shall exist or be implied against the Party which
drafted such terms and provisions.
7.5 NO INCONSISTENT AGREEMENTS. Except for the Compound License
Agreement and the 2002 Consent Agreement, to each of which
Wyeth is a party and under each of which Wyeth requires and
has obtained DOV's consent to enter into this Agreement, as of
the Effective Date of this Agreement neither Party has in
effect nor shall enter into any oral or written agreement or
arrangement that is inconsistent with its obligations under
this Agreement.
8. CONFIDENTIALITY.
8.1 NON-DISCLOSURE AND USE RESTRICTIONS. Except to the extent
expressly authorized by this Agreement or otherwise agreed in
writing, the Parties agree that, for the term of this
Agreement and for five (5) years thereafter, each Party (the
"Receiving Party") receiving any Confidential Information of
the other Party (the "Disclosing Party") hereunder shall keep
such Confidential Information confidential and shall not
publish or otherwise disclose or use such Confidential
Information for any purpose other than as provided for in this
Agreement except for Confidential Information that the
Receiving Party can establish
(a) was already known by the Receiving Party (other than
under an obligation of confidentiality), at the time
of disclosure by the Disclosing Party and such
Receiving Party has documentary evidence to that
effect;
Page 15 of 24
(b) was generally available to the public or otherwise
part of the public domain at the time of its
disclosure to the Receiving Party;
(c) became generally available to the public or otherwise
part of the public domain after its disclosure or
development, as the case may be, and other than
through any act or omission of a Party in breach of
this confidentiality obligation;
(d) was disclosed to that Party, other than under an
obligation of confidentiality, by a Third Party who
had no obligation to the Disclosing Party not to
disclose such information to others; or
(e) was independently discovered or developed by or on
behalf of the Receiving Party without the use of the
Confidential Information belonging to the other Party
and the Receiving Party has documentary evidence to
that effect.
8.2 SEC FILINGS. Either Party may disclose the terms of this
Agreement to the extent required, in the reasonable opinion of
such Party's legal counsel, to comply with applicable laws,
including, without limitation, the rules and regulations
promulgated by the United States Securities and Exchange
Commission (the "SEC"). Notwithstanding the foregoing, before
disclosing this Agreement or any of the terms hereof pursuant
to this Section 8.2, the Parties will consult with one another
on the terms of this Agreement to be redacted in making any
such disclosure. If a Party discloses this Agreement or any of
the terms hereof in accordance with this Section 8.2, such
Party agrees, at its own expense, to seek confidential
treatment of portions of this Agreement or such terms, as may
be reasonably requested by the other Party.
8.3 PUBLIC STATEMENTS. So long as this Agreement is in effect,
neither of the Parties hereto shall issue or cause the
dissemination of any press release or other announcement with
respect to this Agreement or the transactions contemplated
hereby without consulting with and obtaining the consent of
the other Party which consent shall not be unreasonably
withheld; provided, however, that such consent shall not be
required where such release or announcement is required by
applicable law or legal process. The Parties agree that the
press release attached hereto as Exhibit 8.3 may be released
on or after the Effective Date or such earlier date as may be
required by applicable law.
9. TERM AND TERMINATION.
9.1 GOVERNMENT APPROVALS.
9.1.1 HSR FILING. To the extent necessary and to the extent
not already done so prior to the Signature Date, each
of Neurocrine and Wyeth shall, as soon as reasonably
practicable after the Signature Date,
Page 16 of 24
but in no event later than five (5) business days
after the Signature Date, file with the United States
Federal Trade Commission and the Antitrust Division
of the United States Department of Justice, any HSR
Filing required of it in the reasonable opinion of
both Parties under the HSR Act with respect to the
transactions contemplated hereby. The Parties shall
cooperate with one another to the extent necessary in
the preparation of any such HSR Filing. Each Party
shall be responsible for its own costs, expenses, and
filing fees associated with any HSR Filing, provided,
however, that, except as expressly set forth in
Section __ below, Neurocrine shall be solely
responsible for any fees required to be paid to any
government agency in connection with making any such
HSR Filing.
9.1.2 OTHER GOVERNMENT APPROVALS. To the extent not
otherwise addressed in Section 9.1.1 above,
Neurocrine and Wyeth will cooperate and use
respectively all reasonable efforts to make all
registrations, filings and applications, to give all
notices and to obtain as soon as practicable all
governmental or other consents, transfers, approvals,
orders, qualifications authorizations, permits and
waivers, if any, and to do all other things necessary
or desirable for the consummation of the transactions
as contemplated hereby.
9.2 TERMINATION BY MUTUAL AGREEMENT. This Agreement may be
terminated at any time by mutual written agreement of the
Parties.
9.3 TERMINATION FOR CAUSE. This Agreement may be terminated at any
time prior to the Closing Date:
(a) by Wyeth if the Closing shall not have occurred on or
prior to March 31, 2004;
(b) by Neurocrine if the Closing shall not have occurred
on or prior to March 31, 2004; or
(c) subject to Section 9.1, by Wyeth or Neurocrine if a
court of competent jurisdiction or governmental
authority shall have issued an order, decree or
ruling or taken any other action, in each case
permanently restraining, enjoining or otherwise
prohibiting the transactions contemplated by this
Agreement, and such order, decree, ruling or other
action shall have become final and nonappealable.
9.4 EFFECTS OF TERMINATION. Upon expiration or termination of this
pursuant to this Article 9, (a) this Agreement shall forthwith
become null and void, except that nothing herein shall relieve
any Party from liability for breach
Page 17 of 24
of this Agreement prior to such termination. Upon termination
of this Agreement for any reason other than Neurocrine's
failure to meet one or more of the conditions set forth in
Section 6.2 , Wyeth shall refund to Neurocrine the Initial Fee
(without interest) within thirty (30) days following such
termination. Additionally, if this Agreement is terminated as
a result of a failure to meet the condition set forth in
Section 6.2(b), Wyeth, within thirty (30) days of such
termination, shall reimburse Neurocrine the amount of any fees
actually paid by Neurocrine to any government agency in
connection with the making of any HSR Filing pursuant to
Section 9.1.1 above, provided, however, the maximum amount
that Wyeth shall be obligated to so reimburse Neurocrine shall
be forty-five thousand dollars ($45,000). Notwithstanding the
foregoing, this Article 9, Articles 8 and 10 and Sections
4.1(a), 11.3, and 11.8 of this Agreement shall survive any
such expiration or termination.
10. INDEMNIFICATION AND INSURANCE.
10.1 INDEMNIFICATION BY NEUROCRINE. Neurocrine will indemnify,
defend and hold harmless Wyeth, Wyeth's Affiliates, and each
of its and their respective employees, officers, directors and
agents (each, a "Wyeth Indemnified Party") from and against
any and all liability, loss, damage, expense (including
reasonable attorneys' fees and expenses) and cost
(collectively, a "Liability") that the Wyeth Indemnified Party
may be required to pay to one or more Third Parties resulting
from or arising out of or in connection with any Third Party
claims of any nature arising out of:
(a) the research, development, manufacture or
commercialization of the Compound or any
pharmaceutical product containing the Compound by, on
behalf of, or under the authority of Neurocrine, its
Affiliates, and its or their licensees or
sublicensees, and their further licensees or
sublicensees including, without limitation, Pfizer
and any of Pfizer's Affiliates, sublicensees,
contractors or commercialization partners;
(b) any Neurocrine representation or warranty set forth
herein being untrue in any material respect when
made;
(c) any breach or other action taken or omission made by
or on behalf of Neurocrine or any of Neurocrine's
Affiliates under the Compound License Agreement or
the 2002 Consent Agreement; and/or
(d) any action taken or failure to act by Neurocrine, its
Affiliates, any of their respective licensees or
sublicensees (including, without
Page 18 of 24
limitation, Pfizer and Pfizer's Affiliates) and any
of their further licensees or sublicensees, in
connection with the filing, prosecution, maintenance
or enforcement of the Compound Patent, whether such
action or failure to act occurred prior to or after
the Effective Date of this Agreement;
except in each case, to the extent caused by the negligence or
willful misconduct of Wyeth or any Wyeth Indemnified Party.
10.2 INDEMNIFICATION BY WYETH. Wyeth will indemnify, defend and
hold harmless Neurocrine and its sublicensees, distributors
and each of its and their respective employees, officers,
directors and agents (each, a "Neurocrine Indemnified Party")
from and against any and all Liabilities that the Neurocrine
Indemnified Party may be required to pay to one or more Third
Parties resulting from or arising out of any Third Party
claims of any nature arising out of:
(a) the conduct of any activities by, on behalf of, or
under the authority of Wyeth (other than by DOV,
Neurocrine, Pfizer or their respective Affiliates)
prior to the Effective Date of this Agreement; and/or
(b) any Wyeth representation or warranty set forth herein
being untrue in any material respect when made;
except in each case, to the extent caused by the negligence or
willful misconduct of DOV, Neurocrine or any Neurocrine
Indemnified Party.
10.3 PROCEDURE. Each Party will notify the other in the event it
becomes aware of a claim for which indemnification may be
sought hereunder. In case any proceeding (including any
governmental investigation) shall be instituted involving any
Party in respect of which indemnity may be sought pursuant to
this Article 10, such Party (the "Indemnified Party") shall
promptly notify the other Party (the "Indemnifying Party") in
writing within fifteen (15) days and the Indemnifying Party
and Indemnified Party shall meet to discuss how to respond to
any claims that are the subject matter of such proceeding. The
Indemnifying Party, upon request of the Indemnified Party,
shall retain counsel reasonably satisfactory to the
Indemnified Party to represent the Indemnified Party and shall
pay the fees and expenses of such counsel related to such
proceeding. The Indemnified Party agrees to cooperate fully
with the Indemnifying Party in the defense of any such claim,
action or proceeding, or any litigation resulting from any
such claim. In any such proceeding, the Indemnified Party
shall have the right to retain its own counsel, but the fees
and expenses of such counsel shall be at the expense of the
Indemnified Party unless (a) the Indemnifying Party and the
Indemnified Party shall have mutually agreed to the retention
of such counsel or (b) the named parties
Page 19 of 24
to any such proceeding (including any impleaded parties)
include both the Indemnifying Party and the Indemnified Party
and representation of both Parties by the same counsel would
be inappropriate due to actual or potential differing
interests between them. All such fees and expenses shall be
reimbursed as they are incurred. The Indemnifying Party shall
not be liable for any settlement of any proceeding effected
without its written consent, but if settled with such consent
or if there be a final judgment for the plaintiff, the
Indemnifying Party agrees to indemnify the Indemnified Party
from and against any loss or liability by reason of such
settlement or judgment. The Indemnifying Party shall not,
without the written consent of the Indemnified Party, effect
any settlement of any pending or threatened proceeding in
respect of which the Indemnified Party is, or arising out of
the same set of facts could have been, a party and indemnity
could have been sought hereunder by the Indemnified Party,
unless such settlement includes an unconditional release of
the Indemnified Party from all liability on claims that are
the subject matter of such proceeding.
10.4 INSURANCE. Neurocrine further agrees to use reasonable efforts
to obtain and maintain, during the term of this Agreement,
commercial general liability insurance, including products
liability insurance, with reputable and financially secure
insurance carriers to cover its indemnification obligations
under Sections 10.1 with limits of not less than Five Million
Dollars ($5,000,000.00) per occurrence and in the aggregate.
Insurance shall be procured with carriers having an A.M. Best
Rating of A-VII or better. Upon Wyeth's request, Neurocrine
shall provide Wyeth with a certificate of insurance evidencing
said coverage.
10.5 LIMITATION. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER PARTY UNDER THIS AGREEMENT FOR SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES SUFFERED BY SUCH OTHER
PARTY EXCEPT (A) TO THE EXTENT SUCH DAMAGES ARE PAID TO A
THIRD PARTY AS PART OF OR OTHERWISE INCURRED IN CONNECTION
WITH A THIRD PARTY CLAIM AND (B) IN THE EVENT OF INTENTIONAL
AND WILLFUL BREACH IN BAD FAITH OF ANY REPRESENTATION,
WARRANTY OR COVENANT MADE BY SUCH PARTY HEREUNDER.
11. MISCELLANEOUS.
11.1 ASSIGNMENT. Neither this Agreement nor any interest hereunder
shall be assignable by either Party, without the prior written
consent of the other Party, which consent shall not be
unreasonably withheld or delayed, except a Party may make such
an assignment without the other Party's consent to Affiliates
or to a successor to substantially all of the business of such
Party to which this Agreement relates, whether in merger, sale
of stock, sale of assets or other transaction. This Agreement
shall be binding
Page 20 of 24
upon the successors and permitted assigns of the Parties and
the name of a Party appearing herein shall be deemed to
include the names of such Party's successors and permitted
assigns to the extent necessary to carry out the intent of
this Agreement. Any assignment not in accordance with this
Section 11.1 shall be void.
11.2 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other
acts, as may be necessary or appropriate in order to carry out
the purposes and intent of this Agreement.
11.3 NOTICES. All notices and other communications hereunder
(including, without limitation, any notice of breach,
termination, change of address, etc.) shall be in writing and
shall be deemed given if delivered personally or by facsimile
transmission (receipt verified), mailed by registered or
certified mail (return receipt requested), postage prepaid, or
sent by nationally recognized express courier service, to the
Parties at the following addresses (or at such other address
for a Party as shall be specified by like notice, provided,
however, that notices of a change of address shall be
effective only upon receipt thereof):
All correspondence to Wyeth shall be addressed as follows:
Wyeth Pharmaceuticals
500 Arcola Road
Collegeville, PA 19426
Attn: Senior Vice President, Worldwide Licensing
Fax: (484) 865-9301
with a copy to:
Wyeth
5 Giralda Farms
Madison, NJ 07940
Attn: General Counsel
Fax: (973) 660-7156
All correspondence to Neurocrine shall be addressed as
follows:
Neurocrine Biosciences, Inc.
10555 Science Center Drive
San Diego, California 92121
Attn: Senior Vice President, Business Development
Fax: (858) 658-7605
with a copy to:
Page 21 of 24
Neurocrine Biosciences, Inc.
10555 Science Center Drive
San Diego, California 92121
Attn: General Counsel
Fax: (858) 658-7605
11.4 AMENDMENT. No amendment, modification or supplement of any
provision of this Agreement shall be valid or effective unless
made in writing and signed by a duly authorized officer of
each Party.
11.5 WAIVER. No provision of the Agreement shall be waived by any
act, omission or knowledge of a Party or its agents or
employees except by an instrument in writing expressly waiving
such provision and signed by a duly authorized officer of the
waiving Party. The waiver by either of the Parties of any
breach of any provision hereof by the other Party shall not be
construed to be a waiver of any succeeding breach of such
provision or a waiver of the provision itself.
11.6 SEVERABILITY. If any clause or portion thereof in this
Agreement is for any reason held to be invalid, illegal or
unenforceable, the same shall not affect any other portion of
this Agreement, as it is the intent of the Parties that this
Agreement shall be construed in such fashion as to maintain
its existence, validity and enforceability to the greatest
extent possible. In any such event, this Agreement shall be
construed as if such clause of portion thereof had never been
contained in this Agreement, and there shall be deemed
substituted therefor such provision as will most nearly carry
out the intent of the Parties as expressed in this Agreement
to the fullest extent permitted by applicable law.
11.7 DESCRIPTIVE HEADINGS. The descriptive headings of this
Agreement are for convenience only, and shall be of no force
or effect in construing or interpreting any of the provisions
of this Agreement.
11.8 GOVERNING LAW; DISPUTE RESOLUTION. This Agreement shall be
governed by and interpreted in accordance with the substantive
laws of the State of New York, without regard to conflict of
law principles thereof. The Parties recognize that a bona fide
dispute as to certain matters may from time to time arise
during the term of this Agreement. In the event of the
occurrence of such a dispute either Party may, by written
notice to the other Party, have such dispute referred to their
respective officers (designated below) or their successors or
designees for attempted resolution by good faith negotiations
within ten (10) calendar days after such notice is received.
Said designated officers are as follows:
For Wyeth: Senior Vice President
Page 22 of 24
Global Business Development
Wyeth Pharmaceuticals
For Neurocrine: Senior Vice President,
Business Development
In the event the designated officers are not able to resolve
such dispute through good faith negotiations within such ten
(10) calendar day period, either Party may pursue any legal or
equitable remedies available to it by filing a claim in the
state or federal courts of the state of New York and each
Party hereby consents to the jurisdiction of such court and
each Party hereby irrevocably waives its right to a jury trial
before such court. Notwithstanding the foregoing, nothing in
this Section 11.8 shall prohibit a Party from seeking
temporary or injunctive relief from a state or federal court
in New York pending the resolution of a dispute in accordance
with the provisions of this Section 11.8.
11.9 ENTIRE AGREEMENT OF THE PARTIES. This Agreement constitutes
and contains the complete, final and exclusive understanding
and agreement of the Parties as to the subject matter hereof
and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether oral or
written, among the Parties respecting the subject matter
hereof,. Except as expressly provided otherwise herein, this
Agreement shall have no effect on, and shall be subject to,
the 2002 Consent Agreement, the 2004 Consent Agreement, the
Sublicense Agreement and Compound License Agreement which
agreements shall continue in full force and effect in
accordance with the terms and conditions thereof and subject
to the assignments and assumptions effected pursuant to this
Agreement.
11.10 INDEPENDENT CONTRACTORS. Both Parties are independent
contractors under this Agreement. Nothing herein contained
shall be deemed to create an employment, agency, joint venture
or partnership relationship between the Parties hereto or any
of their agents or employees, or any other legal arrangement
that would impose liability upon one Party for the act or
failure to act of the other Party. Neither Party shall have
any express or implied power to enter into any contracts or
commitments or to incur any liabilities in the name of, or on
behalf of, the other Party, or to bind the other Party in any
respect whatsoever.
Page 23 of 24
11.11 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which need not contain the signature of
more than one Party but all such counterparts taken together
shall constitute one and the same agreement.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have
duly executed this Agreement to be effective as of the Signature Date.
WYETH HOLDINGS CORPORATION NEUROCRINE BIOSCIENCES, INC.
By /s/ Robert A. Dougan By /s/ Gary A. Lyons
Name: Robert A. Dougan Name: Gary A. Lyons
Title: Senior Vice President Title: President and CEO
Page 24 of 24
EXHIBIT 1.7
FORM OF COMPOUND LICENSE AGREEMENT
LICENSE AGREEMENT
THIS AGREEMENT (the "Agreement") is entered into on this __th day of
February, 2004 by and between DOV PHARMACEUTICAL, INCORPORATED, a corporation
organized and existing under the laws of the Delaware, having its registered
offices at Continental Plaza, 433 Hackensack Avenue, Hackensack, New Jersey
07601, (hereinafter DOV) and WYETH HOLDINGS CORPORATION (formerly known as
"American Cyanamid Company"), a corporation organized under the laws of the
State of Maine, U.S.A., having its principal place of business at 5 Giralda
Farms, Madison, New Jersey 07940, U.S.A., (hereinafter Wyeth).
WITNESSETH:
WHEREAS, DOV and Wyeth entered into that certain License Agreement
dated May 29, 1998 (as previously amended, the "Original License Agreement")
pursuant to which Wyeth granted to DOV a worldwide exclusive license for a group
of four (4) specified compounds;
WHEREAS, on even date herewith DOV and Wyeth entered into an Amended
and Restated License Agreement, which agreement amends and restates the Original
License Agreement so as to remove from such agreement the rights and licenses
granted to DOV and the other rights and obligations of each of the parties
thereunder, in each case, which rights, licenses and obligations relate to the
compound designated as CL 285,489 (also known as Indiplon);
WHEREAS, DOV and Wyeth now desire to enter into this license agreement
to provide for the grant of a worldwide, exclusive license to DOV under certain
intellectual property rights of Wyeth for the development and commercialization
of CL 285,489;
WHEREAS, Wyeth possesses intellectual property rights relating to the
chemical compound listed in Schedule 1 attached hereto and made a part hereof
and to pharmaceutical products to be processed from the aforesaid compound.
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WHEREAS, Wyeth designates Wyeth Pharmaceuticals, an Affiliate of Wyeth,
with principal offices at 500 Arcola Road, Collegeville, Pennsylvania 19426,
U.S.A., as the correspondent and contact for day-to-day business regarding the
compounds that appear in Schedule 1. All correspondence and contacts shall be
with Wyeth Pharmaceuticals.
WHEREAS, DOV is interested to develop as well as manufacture, have
manufactured by, use, and sell pharmaceutical products containing CL 285,489
worldwide under a license that Wyeth is willing to grant.
NOW, THEREFORE, in consideration of the premises and the mutual
covenants and agreements set forth herein, the parties hereto agree as follows:
ARTICLE 1.0 DEFINITIONS
1.1 "Effective Date" means the date upon which this License Agreement is
executed by both parties.
1.2 "Product" means the compound listed in Schedule 1.
1.3. "Marketed Product" means the pharmaceutical preparation in finished
form containing Product suitable for human administration, whether
alone or in combination with other active ingredients.
1.4 "Wyeth Patents" means all patents, certificates of invention, and
applications covering the Product. Such Wyeth Patents are listed in
Exhibit A of this License Agreement.
1.5 "Wyeth Know-How" means all information, patentable or otherwise,
developed, applied, or acquired by Wyeth as of May 22, 1997 relating to
the production or development of the Product that is reasonably useful
or necessary to develop or manufacture Product.
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1.6 "Wyeth's Place of Payment" means 500 Arcola Road, Collegeville,
Pennsylvania 19426.
1.7 "Affiliate" means with respect to a party, any other business entity
that directly or indirectly controls, is controlled by, or is under
common control with, such party. A business entity or party shall be
regarded as in control of another business entity if it owns, or
directly or indirectly controls, at least fifty percent (50%) of the
voting stock or other ownership interest of the other business entity,
or if it directly or indirectly possesses the power to direct or cause
the direction of the management and policies of the other business
entity by any means whatsoever.
1.8 "Net Sales" shall mean the gross amount invoiced for the Marketed
Product sold by DOV and/or its Affiliates or their sublicensees
(including any further sublicensees), less:
(i) transportation charges or allowances, if any, included in such
price;
(ii) trade, quantity or cash discounts, service allowances and
broker's or agent's commissions but not salaries, commissions,
bonuses or other incentive pay to in-house sales or other
personnel, if any, allowed or paid;
(iii) credits or allowances, if any, given or made on account of
price adjustments, returns, bad debts, off-invoice promotional
discounts, rebates, and any all Federal, state or local
government rebates whether in existence now or enacted at any
time during the term of this Agreement (e.g., HCFA or Medicaid
rebates), rejections, recalls or destruction requested or made
by an appropriate government agency; and
(iv) any tax, excise or governmental charge upon or measured by the
sale, transportation, delivery or use of the Marketed Product;
provided that Net Sales shall in no event be less than 80% of Gross
Sales.
In the case of discounts on "bundles" of products which include the
Marketed Product, DOV, its Affiliates and its sublicensees (including
further sublicensees) may, with notice
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to Wyeth, calculate Net Sales as set forth above discounting the bona
fide list price of the Marketed Product by the average percentage
discount of all products of the selling party and/or its Affiliates or
sublicensees in a particular "bundle", calculated as follows:
Average percentage
discount on a = (1-A/B) x 100
particular "bundle"
where A equals the total discounted price of a particular "bundle" of
products, and B equals the sum of the undiscounted bona fide list
prices of each unit of every product in such "bundle". DOV shall
provide Wyeth documentation, reasonably acceptable to Wyeth,
establishing such average discount with respect to each "bundle". Where
the Marketed Product is also sold other than in bundled form, the
average discount as calculated above shall be applied to the
undiscounted list price of the Marketed Products in the "bundle". If
the Marketed Product is not sold separately and no bona fide list price
exists for the Marketed Product, the parties shall negotiate in good
faith an imputed list price for the Marketed Product, and the average
discount as calculated above with respect thereto shall be applied to
such imputed list price.
1.9 "Territory" means all countries of the world.
1.10 "Scheduled Payments" means those lump sums payable at the time of the
achievement of specific developmental activities during the development
period through actual commercial introduction of a Product following
regulatory approval.
1.11 As used in this e Agreement, the singular includes the plural and the
plural includes the singular, wherever appropriate by fact or by
context.
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ARTICLE 2.0 LICENSE GRANT
2.1 Effective as of May 29, 1998, Wyeth hereby grants DOV an exclusive
license under Wyeth Patents and Wyeth Know-How to make, have made, use,
import, offer for sale and/or sell Marketed Product in the Territory.
2.2 Subject to Wyeth's right of first refusal provided for in Article 4.0,
and the provisions in Article 5.0; DOV shall have the right to grant
sublicenses under the License provided for in Article 2.1.
ARTICLE 3.0 DEVELOPMENTAL ACTIVITIES
3.1 While this Agreement is in effect, DOV shall use reasonable efforts to
develop and commercialize the Product, either through itself or through
a third party commercial partner. Such activities include negotiating
the terms of a sublicense agreement with a third party.
3.2 DOV may disclose unpublished Wyeth Patents and Wyeth Know-How to a
third party, bound under an obligation of confidentiality which is
substantially the same as the obligation provided for in Article 7 of
this License Agreement, to the extent necessary to negotiate a
sublicense, and thereafter to develop and commercialize the Product.
3.3 On a quarterly basis, DOV shall provide Wyeth with a written report
outlining its developmental activities during that quarter.
ARTICLE 4.0 WYETH RIGHT OF FIRST REFUSAL
4.1 Prior to its entering into a sublicense agreement with a third party
with respect to Product, DOV shall present, in writing, to Wyeth the
bona fide proposed terms and conditions of said sublicense agreement.
Following receipt by Wyeth of said terms and conditions, Wyeth shall
have sixty (60) days to notify DOV if it intends to enter into a
development agreement with DOV, the terms of which would exceed those
proposed by a third party by 10% relative to Scheduled Payments and
royalties. So as to permit Wyeth to reach
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such decision, DOV shall provide to Wyeth all relevant data and
information regarding Product available to DOV, simultaneously with its
providing to Wyeth the terms and conditions offered by the said third
party.
4.2 Upon Wyeth's providing DOV with notification of its intent to enter
into an agreement with DOV pursuant to Article 4.1, the parties will
promptly negotiate said agreement embodying Wyeth's offer under Article
4.1 and this License Agreement shall terminate upon the effective date
of said agreement, solely with regard to the Product(s) elected by
Wyeth under Article 4.1 and contained in said agreement.
4.3 If Wyeth does not notify DOV of its intention to enter into an
agreement with DOV pursuant to Articles 4.1 and 4.2, hereinabove,
within the agreed upon period, DOV shall be free to enter into a
sublicense agreement with the third party under the terms presented to
Wyeth, or better.
4.4 In the event that DOV files a New Drug Application (NDA) in the USA, or
a foreign equivalent thereof in Europe or Japan, but has not yet
entered into a license agreement with a third party for Product, DOV
shall provide Wyeth with a copy of the NDA ( or the foreign equivalent
thereof as filed together with its English translation) for evaluation
by Wyeth. If Wyeth shall express an interest in marketing the Product,
then the parties shall enter into good faith negotiations relating to
the possibility of Wyeth's obtaining marketing rights to the Product.
ARTICLE 5.0 SUBLICENSE AGREEMENTS
5.1 If DOV grants a sublicense to a third party with regard to Product
under this Agreement, such sublicense agreement shall provide for DOV
to receive Scheduled Payments and royalty payments based on Net Sales
of Marketed Product.
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ARTICLE 6.0 PAYMENTS
6.1 Within thirty (30) days after the Effective Date of the Original
License Agreement, DOV shall pay Wyeth the fee as indicated below in
this paragraph 6.1 for exercising its Option rights with regard to each
Product. Such fee shall be non-refundable and non-creditable against
any other payments due Wyeth pursuant to this Agreement:
CL 285,489 $ 50,000
Wyeth acknowledges that the fee provided for in this Section 6.1 has
been received.
6.2 If DOV enters into a sublicense agreement with a third party before the
filing of an NDA (or the foreign equivalent thereof in Europe or Japan)
for a Product, DOV shall, subject to the minimum conditions set forth
in paragraph 6.4 of this Agreement, pay Wyeth during the term of this
Agreement 35% of all remuneration, excluding all adequately documented
future research and development payments, whether tangible or
intangible, including all Scheduled Payments within 30 days of receipt
by DOV from such sublicensee and one-third of all other royalties and
profits, whether tangible or intangible, within 30 days of receipt by
DOV derived from the final sale to the trade of Marketed Product by DOV
or its sublicensee, as the case may be.
6.3 If DOV enters into a sublicense agreement with a third party after the
filing of an NDA (or the foreign equivalent thereof in Europe or Japan)
for a Product, DOV shall, subject to the minimum conditions set forth
in paragraph 6.4 of this Agreement, pay Wyeth during the term of this
Agreement 25% of all remuneration, whether tangible or intangible,
including Scheduled Payments within 30 days of receipt by DOV from such
sublicensee; and 25% of all other royalties and profits; whether
tangible or intangible, within 30 days of receipt by DOV derived from
the final sale to the trade of Marketed Product by DOV or its
sublicensee, as the case may be.
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6.4 Notwithstanding any other provision of this Agreement, Wyeth shall in
no event receive Scheduled Payments and once the Product has been
commercialized, royalties on sales of Marketed Product to the trade by
DOV or its third-party sublicense with respect to each Product listed
in Schedule 1, which Scheduled Payments, in the aggregate, and
royalties are less than the amounts below indicated in this paragraph.
For the sake of clarity, in the event the portion of the first
Scheduled Payment received by DOV from a sublicensee which portion is
payable by DOV to Wyeth in accordance with Section 6.2 above, is less
than the amount indicated below in this paragraph, DOV shall pay to
Wyeth the minimum amount set forth below at such time and that portion
of such minimum amount that is in excess of the amount payable by DOV
to Wyeth pursuant to Section 6.2 above as the result of DOV's receipt
of such Scheduled Payment from its sublicensee, shall be credited
against any further Scheduled Payments due from DOV to Wyeth under this
Agreement.. The Scheduled Payments due Wyeth for the Schedule 1
compound shall be paid pursuant to the 30-day period specified in
paragraphs 6.2 and 6.3 if received by DOV from third parties; but in
the event that DOV achieves the filing of an NDA, or its equivalent in
the United States, Europe, or Japan for a Product without assistance of
a third party, DOV shall remit to Wyeth the aggregate minimum Scheduled
Payments set forth below no later than 30 days following the
achievement of such Regulatory filing.
AGGREGATE MINIMUM SCHEDULED MINIMUM ROYALTY DUE TO
PAYMENT FOR EACH PRODUCT DUE WYETH WYETH ON NET SALES
- ---------------------------------- ------------------
CL 285,489 $2.5 Million 2.5%
Provided however if marketing exclusivity in any country of the
Territory is lost to DOV or its sublicensee prior to the expiration of
this Agreement in such country, the parties shall meet to discuss
whether any modification to these terms is appropriate.
6.5 DOV shall keep and shall obligate its sublicensees to keep accurate and
complete records of all sales of Product and Marketed Product in
accordance with generally
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accepted accounting principles and practices. In any agreement between
DOV and a third party, DOV shall obligate such third party to allow
routine audits by Wyeth of such third party's records relating to the
Product and Marketed Product and shall further require such third party
to likewise obligate any additional third party that enters into an
agreement with the third party relating to the Product and Marketed
Product to allow routine audits by Wyeth of such additional third
party's records relating to the Product and Marketed Product. Wyeth, no
more than one time per calendar year for each of DOV or any third party
so audited, may conduct, at its own expense, at reasonable times during
normal business hours, through an accountant designated by Wyeth and
acceptable to DOV (and its sublicensees and their sublicensees, as
appropriate), an audit of the accounts contemplated above, as well as
any supporting instruments and documents, and may make copies of and
extracts from such records for the sole purpose of ascertaining or
verifying the correctness of the amounts remitted by DOV hereunder.
Such accountant shall be required by DOV or any sublicensee to enter
into a reasonably acceptable confidentiality agreement, and in no event
shall such accountants disclose to Wyeth or DOV any information other
than information relating to or supporting the accuracy of the payments
due from DOV hereunder (and, except to the extent necessary to support
sales data using bundles, in no event information that relates to
products other than the Product or Marketed Product). Each such audit
shall be limited to the records and accounts pertaining to the year on
which the audit is conducted and the immediately preceding 5 calendar
years. Results in the form of a report of such audit shall be made
available by Wyeth to DOV and to any third party that is the subject of
the audit. Should such audit reveal any discrepancies between reports
made by DOV or its sublicensees and the audit exceeding five percent
(5%) in favor of DOV or any third party that is audited, then DOV shall
pay in full the costs of such audit requested by Wyeth; otherwise,
Wyeth shall bear the costs in full for the audit of the records of DOV,
its Affiliates, or its sublicensees. In the event DOV, its Affiliates
or sublicensees (including further sublicensees) conducts an audit of
any sublicensee selling the Product and Marketed Product, DOV shall
provide or shall cause such Affiliate or sublicensee to provide to
Wyeth a copy of each audit report generated in connection therewith.
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6.6 Royalty payments shall be due within the shorter period of thirty (30)
days following receipt thereof by DOV or sixty (60) days of the end of
each calendar quarter on Net Sales made in that quarter and shall be
paid at Wyeth's Place of Payment. Royalties shall accrue in the
currency of the country in which the sale of Marketed Product is made,
and if different from U. S. dollars shall be converted into such
currency using the exchange rate appearing in the Wall Street Journal
applicable for the last day of the calendar quarter during which the
royalties accrued.
6.7 All taxes, assessments, fees. and charges, if any, levied under income
tax laws or regulations with respect to payments due Wyeth hereunder
shall be for the account of Wyeth and if required by law to be withheld
and paid to the applicable jurisdiction, may be deducted by DOV from
such payments due to Wyeth. Receipts for all such deducted taxes,
assessments, fees and charges paid by DOV to the taxing authorities
shall be secured by DOV and sent to Wyeth.
6.8 In case of any delay in payment by DOV to Wyeth not occasioned by force
majeure, interest at the rate of one percent (1%) per month, assessed
from the thirty-first day after the due date of the said payment, shall
be due Wyeth without any special notice.
ARTICLE 7.0 CONFIDENTIALITY
7.1 If during the performance of this Agreement, one party hereto wishes to
disclose information to another that it considers confidential, and if
the receiving party is willing to accept such information, then such
information may not be subsequently disclosed by the receiving party to
a third party, other than as provided in this Agreement, without the
written permission of the disclosing party. The parties to this
Agreement agree to hold in confidence all information and all
knowledge, know-how, practices, process, or other information disclosed
or submitted in writing or in other tangible form that is considered to
be confidential for a period of five (5) years from the date of such
disclosure, except:
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(a) information that, at the time of disclosure, is in the public
domain;
(b) information that, after disclosure, is published or otherwise
becomes part of the public domain through no fault of the
receiving party;
(c) information that was in the possession of the receiving party
at the time of disclosure;
(d) information that is developed by or on behalf of the receiving
party independently of any disclosure to it by the disclosing
party hereunder; or
(e) information that is provided to the receiving party by a third
party with the right to so provide.
ARTICLE 8.0 ADVERSE EXPERIENCE
8.1 DOV shall keep (and DOV shall cause its sublicensees to keep under
terms and conditions equal to those set forth in this Article 8) Wyeth,
during the term of this Agreement, promptly and fully informed of all
pharmaceutical, toxicological and clinical findings relating to adverse
experience of the Product or Marketed Product.
8.2 DOV undertakes to notify Wyeth promptly with written confirmation by
immediate telecopy of any information concerning any serious adverse
event as defined by C.I.O.M.S. or the F.D.A. or by the Ministry of
Health & Welfare in Japan, as applicable, reasonably associated with
clinical studies or attributed to the use or application of the Product
and Marketed Product. In any event the above notification shall be made
within two working days after DOV should first learn or be advised of
all relevant information with respect to such adverse event.
8.3 DOV shall also forward regularly (and usually every six months unless
the parties agree on another period) to Wyeth any information on all
other adverse effects or any difficulty
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associated with the clinical use, studies, investigations, tests and
prescription of the Product or Marketed Product.
8.4 DOV shall provide upon request the information on patient exposure:
estimated patient days of exposure.
8.5 DOV shall inform Wyeth, without delay, of any governmental action,
correspondence or reports to or from governmental authorities that may
affect the situation of the Product or Marketed Product and furnish
Wyeth with copies of any relevant documents relating thereto.
ARTICLE 9.0 REPRESENTATIONS AND WARRANTIES
9.1 Wyeth hereby represents and warrants that it has the right to grant DOV
the license under Article 2 of this Agreement, and that, as of the
effective date of the Original License Agreement, Wyeth is not aware of
any lawsuit, opposition or action of any kind questioning or contesting
the validity of the Wyeth Patents. Notwithstanding the foregoing, Wyeth
makes no other warranties, expressed or implied, and Wyeth does not
warrant, nor does it entitle any agent, officer, employee or
representative of Wyeth to warrant validity, enforceability, efficacy,
merchantability, fitness for a particular purpose or otherwise with
respect to any Product, Marketed Product or Wyeth Patent as the case
may be.
9.2 DOV is fully cognizant of Good Laboratory Practices ("GLP") and Good
Manufacturing Practices ("GMP") and shall manufacture or have
manufactured Product and Marketed Product in a manner that fully
complies with GLP and GMP.
ARTICLE 10.0 INDEMNIFICATION, LIABILITY AND INSURANCE
10.1 DOV shall at all times during the term of this Agreement, and
thereafter, indemnify, defend and hold Wyeth and all its Affiliates and
their respective directors, officers, partners, employees, servants and
agents harmless from and against any and all claims
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and expenses, including without limitation legal expenses, court costs,
and reasonable attorney's fees, arising out of or relating to the death
of or actual or alleged injury to any person or damage to any third
party's property, and from and against any other claim, proceeding,
demand, expense, cost and liability of any kind whatsoever
(collectively "liabilities") resulting from, arising out of or related
to Product or Marketed Product.
10.2 DOV shall take all necessary steps, at its own costs, and shall so
obligate its sublicensee to properly maintain insurance policies to
cover all liabilities to any third party that might be incurred,
directly or indirectly as a result of its participation in the
performance of this Agreement.
10.3 DOV shall maintain (and shall cause its sublicensee to maintain)
product liability insurance that may include funded self-insurance
reserves with respect to the development, manufacture and sale of the
Product and Marketed Product in such amount as customary in the
industry. DOV (and its sublicensee) shall maintain such insurance for
so long as it continues to develop, manufacture or sell any Product and
Marketed Product and thereafter for so long as required to cover such
manufacture or sales.
DOV (and its sublicensee) shall name Wyeth as an additional insured on
its insurance policy. Upon execution of the Original License Agreement
DOV has supplied and during the term of this Agreement, upon Wyeth's
request, DOV shall supply Wyeth with evidence of such coverage, and
undertakes to communicate to Wyeth during the term of this Agreement
any modifications to such coverages.
ARTICLE 11.0 USE OF NAMES/ TRADEMARKS/PUBLICITY
11.1 Neither party shall use the name of the other party in any advertising
or other form of publicity without the written permission of the other.
11.2 By virtue of this License Agreement, DOV shall not acquire any right to
use trademarks, tradedress or other indicia of origin belonging to
Wyeth, or any of its Affiliates.
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11.3 The timing and content of any press release or other public
communications relating to this Agreement and the transactions
contemplated herein shall, except as otherwise required by law, be
determined jointly by Wyeth and DOV.
ARTICLE 12.0 PATENT INFRINGEMENTS
12.1 Wyeth shall be responsible for the filing, prosecution and maintenance
of the Wyeth Patents. Wyeth shall not allow any issued Patent included
within the Wyeth Patents and listed or Exhibit A attached hereto to
lapse (by reason of failure to pay maintenance fees or annuities or to
take any other action necessary to maintain such patent in full force
and effect) or admit the invalidity thereof prior to the mutual
expiration date thereof without DOV"s prior consent.
12.2 In case any actions, claims, demands, suits or other legal proceedings
are brought or threatened to be brought against DOV by a third party
for infringement of such third party's patent(s) relating to Product
per se, by virtue of DOV's manufacture, use, sale or offer for sale of
the Product or Marketed Product hereunder, DOV shall notify Wyeth
forthwith of the threat or existence of such actions with sufficient
evidence thereof to enable the parties to prepare an appropriate
defense. strategy. The parties shall consult together as to the action
to be taken and as to how the defense will be handled. DOV shall be
responsible for all defense costs.
DOV undertakes not to make any admission of liability to a claimant or
plaintiff or his or her legal representative or insurer and not to sign
any agreement in respect of such proceedings without Wyeth's previous
written consent not to be unreasonably withheld.
When DOV, because of the settlement with Wyeth's consent of the claimed
infringement, or a final unappealable or non-appealed judgment of a
court of competent jurisdiction, is required to make payments to one or
more third parties to obtain a license without which the marketing of
the Marketed Product could not be made in a given country, DOV may
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deduct such payments from the royalty payments due to Wyeth hereunder,
provided however that in no event shall the royalty rate be reduced by
more than fifty percent (50%) of that which would otherwise be due
Wyeth.
12.3 DOV shall promptly inform Wyeth of any suspected infringement of any of
Wyeth Patents by a third party and provide Wyeth with any available
evidence of such suspected infringement.
Wyeth shall have the right but not the obligation to institute any
claim, suit or proceeding against an infringer or a presumed infringer
to protect and defend Wyeth Patents. Wyeth shall control the
prosecution of any such suit or claim, including without limitation the
choice of counsel and shall settle or dispose of any such suit or
claim. DOV shall provide Wyeth with all reasonable assistance (other
than financial) required to institute and maintain such proceedings. In
the event Wyeth so elects, Wyeth shall bear the entire costs of such
prosecution and shall be entitled to retain, after deducting the costs
and expenses borne by Wyeth in prosecuting the claim of infringement,
ninety percent (90%) of the amount of any recovery, court award or
settlement.
DOV shall not institute any negotiations or legal proceedings with
respect to any such infringement without prior written consent of
Wyeth, but shall have the right to institute infringement proceedings
against a third party in the event that Wyeth elects not to do so. In
such event, DOV shall bear the entire costs and expenses of such
proceedings. Wyeth shall provide DOV with all reasonable assistance
(other than financial) required to institute and maintain such
proceedings. In such event, DOV shall be entitled to retain ninety
percent (90%) of the proceeds of any such recovery, after first
deducting the costs and expenses borne by DOV in initiating and
maintaining such infringement action and shall pay the remainder to
Wyeth.
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ARTICLE 13.0 DURATION AND TERMINATION
13.1 This Agreement shall be binding on the parties as of the day of its
execution but shall have no force or effect until either the parties
determine that notification under Title II of the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, 15 U.S.C. 18a, and the regulations
promulgated thereunder, 16 C.F.R. 801.1 et seq., is not required or if
the parties determine that such notification is required, the waiting
period shall have expired or been terminated. If a notification filing
is required, the parties shall, at their own expense, prepare and make
all appropriate filings. The parties shall cooperate in the antitrust
clearance process and hereby agree to furnish promptly to the FTC and
the Antitrust Division of the Department of Justice such additional
information reasonably requested by them in connection with such
filings. In the event that the waiting period has not expired or been
terminated within six (6) months after the date of signature of this
agreement by both parties, the parties shall revert to their status
before signing and this agreement shall be of no force and effect,
except for Articles 7, 10, and 11 which shall survive pursuant to their
terms. Thereafter, the Agreement shall continue in full force and
effect in each country of the Territory until the later of expiration
of the Wyeth Patents in such country or a period of ten (10) years
following the launch of such Marketed Product by DOV or its
sublicensee(s) in each country of the Territory.
13.2 Upon expiration of this Agreement with respect to each country of the
Territory, DOV shall be deemed to have a fully-paid, royalty-free
license with the right to make or have made, use or sell Product and
Marketed Product as well as to freely utilize all data generated
hereunder or received from Wyeth by DOV without DOV's having further
obligation to Wyeth, except for maintaining confidentiality as required
by Article 7.1 of this Agreement.
13.3 DOV shall be free to terminate this entire Agreement and surrender and
return to Wyeth all rights acquired by DOV hereunder in its own
discretion at any time upon 90 days' prior written notice at which time
all license rights granted hereunder shall come to an end.
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13.4 In the event that a party hereto shall be presumed by the other to have
breached any material condition herein contained, the complaining party
shall be required to provide a formal written notice of such presumed
breach, requesting rectification within a sixty-day period from the
date of receipt of such notice. The party presumed to be in breach of
this Agreement shall either submit a commercially reasonable plan for
rectification within 45 days of receipt of notice (if the breach cannot
be rectified within the sixty-day period), or take appropriate steps to
remedy the breach if capable of remedy within such period. If within
the said sixty-day period neither the aforesaid plan has been
submitted, nor the breach cured, the party alleging breach shall then
be entitled to terminate this Agreement, thereby surrendering all
rights granted hereunder, by written notice to the other party, such
termination having immediate effect.
13.5 This Agreement may be terminated at once by Wyeth giving notice to DOV
if DOV is insolvent or has committed an act of bankruptcy or an order
is made or resolution passed for the winding up of either party.
13.6 In the event this Agreement is terminated prior to its full term
pursuant to paragraph 13.3 by DOV or pursuant to paragraphs 13.4 or
13.5 by Wyeth, DOV shall within thirty (30) days of such event transfer
to Wyeth all information, data and know-how of any kind relating to the
Product and shall authorize the transfer of all governmental approvals
for the Product to Wyeth, in addition to DOV's right derived from all
license agreements between DOV and its third party partners relative to
Product and Marketed Product.
ARTICLE 14.0 REPORTS AND NOTICES
14.1 Upon Wyeth's request, DOV shall provide Wyeth an annual report
summarizing the stage of development relating to the Product. Such
report shall be provided within thirty (30) days of each anniversary of
the signing of this Agreement.
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14.2 DOV shall notify Wyeth in writing within fifteen (15) days after
achieving an event that would require that a Scheduled Payment be paid
by a third party to DOV, or by DOV to Wyeth, with respect to the
Product.
14.3 Not later than sixty (60) days following the end of each quarter, DOV
shall provide Wyeth with a report summarizing the Net Sales of Marketed
Product in each country in the Territory made by DOV or a third party
sublicensee of DOV. Such reporting shall begin following the first sale
of Marketed Product in the Territory.
14.4 Any notices or reports required or permitted to be given under this
Agreement shall be sent by certified or registered mail, or by an
equivalent service that provides verification of delivery, return
receipt requested to the respective party at the address stated below
or such address as to which the parties are subsequently appropriately
notified:
If to Wyeth: Wyeth
500 Arcola Road
Collegeville, PA 19426
Attn: Senior Vice President, Global Business Development
If to DOV: DOV Pharmaceutical, Inc.
Continental Plaza
433 Hackensack Avenue
Hackensack, NJ 07601
Attn: President
ARTICLE 15.0 ASSIGNMENT
15.1 This Agreement shall be binding upon and inure to the benefit of the
parties hereto and the successors to substantially the entire business
and assets of the respective parties hereto. Notwithstanding the
foregoing, any party may void this Agreement if the Agreement is
assigned for the benefit of a creditor. This Agreement shall not be
18
assignable by either party, except to an Affiliate, without the prior
written consent of the other party; any other attempted assignment is
void.
ARTICLE 16.0 APPLICABLE LAW
16.1 This Agreement shall be governed by and construed according to the laws
of the State of New York, USA.
ARTICLE 17.0 FORCE MAJEURE
17.1 None of the parties shall be responsible for failure or delay in the
performance of any of its obligations hereunder due to Force Majeure.
Force Majeure shall mean any circumstance that, due to an event or a
legal position beyond the party's reasonable control, renders
impossible the fulfillment of any of the party's obligations hereunder,
such as, but not limited to, acts of God, acts, regulations, or laws of
any government, war, civil commotion, destruction of facilities or
materials by fires, earthquakes, or storms, labor disturbances,
shortages of public utilities, common carriers, or raw materials, or
any other cause, or causes of similar effects, except, however, any
economic occurrence. During any such case of Force Majeure, this
Agreement shall not be terminated, but only suspended and the party so
affected shall continue to perform its obligations as soon as such case
of Force Majeure is removed or alleviated.
ARTICLE 18.0 MISCELLANEOUS
18.1 This Agreement and the Schedules hereto constitute the full
understanding and entire agreement between the parties and supersedes
and replaces any and all prior oral or written understandings and
agreements with respect to the subject matter hereof including, without
limitation, the Original License Agreement. Notwithstanding the
foregoing, this Agreement shall not be deemed to have modified (i) the
Consent and Agreement entered into by Wyeth, DOV and DOV's sublicensee,
Neurocrine Bioscience's Inc. ("Neurocrine"), on December 13, 2002, (ii)
the Consent Agreement and
19
Amendment entered into by Wyeth, DOV and Neurocrine on February __,
2004, or (iii) the Sublicense and Development Agreement entered into by
DOV and Neurocrine June 30, 1998, each of which shall remain in full
force and effect in accordance with the terms and conditions thereof as
amended from time to time. This Agreement shall not be effective until
duly signed by officers of both Wyeth and DOV. No terms, conditions,
understandings or Agreements purporting to modify, amend or vary this
Agreement shall be binding unless made in writing and signed by the
parties hereto. It is mutually agreed that no party has relied upon any
representations or statements of any third party except as stated
herein.
18.2 The invalidity or unenforceability of an Article or any part of an
Article of this Agreement in any jurisdiction shall not cause the
invalidity of the whole Agreement as to such jurisdiction, and shall
not affect the validity or enforceability of such Article or such part
of an Article in any other jurisdiction. The parties shall replace any
Article or part of an Article found invalid or unenforceable by
alternative provisions which shall be as similar as possible in their
conditions with regard to their spirit and commercial effect. If this
Agreement in any jurisdiction is found to be invalid or unenforceable,
the parties shall replace it by an alternative Agreement which shall be
as similar as possible in its conditions with regard to its spirit and
commercial effect.
18.3 The failure of either party on any occasion to require the performance
by the other of any provision hereof shall in no manner affect the
right of such party to enforce the same on a subsequent occasion. The
waiver by either party of any breach of any provision hereof shall at
no time be construed to be a waiver of any succeeding breach of that or
any other provision or a waiver of the provision itself.
18.4 This Agreement shall not constitute either party as the joint venturer,
legal representative or agent of the other party for any purpose
whatsoever. Neither party shall have any right or authority to assume
or create any obligation or responsibility for or on behalf of the
other party or to otherwise bind the other party.
20
18.5 The parties recognize that this is a master Agreement covering a number
of countries. If for any country in the Territory it becomes necessary
to execute a separate instrument for such country in order to satisfy
local regulatory requirements, the parties agree to execute such
further instrument; that shall to the extent permitted by the laws of
the country conform to the terms and conditions of this Agreement.
18.6 This Agreement and the Schedules and Exhibits hereto are originally
prepared and signed in the English language. If any translation into
any other language is legally required for purposes of governmental
filings, the parties shall arrange for such translation, and the costs
thereof shall be borne by the party legally required to make such
filing. In the event of any question or dispute as to the meaning or
interpretation of any term, condition or provision of this Agreement,
or any Schedule or Exhibit hereto, the English language version shall
in all events govern for all purposes whatsoever.
18.7 Termination of this Agreement for any reason, or expiration of this
Agreement, will not affect: (i) obligations, including the payment of
any Scheduled Payments or royalties that have accrued as of the date of
termination or expiration, and (ii) rights and obligations which, from
the context thereof, are intended to survive termination or expiration
of this Agreement.
18.8 This Agreement is executed simultaneously in counterparts, each of
which shall be deemed an original, but all of which shall constitute
but one and the same instrument.
WYETH HOLDINGS CORPORATION DOV PHARMACEUTICAL, INC.
NAME: NAME:
TITLE: TITLE:
DATE: DATE:
21
SCHEDULE 1
PRODUCTS
CL 285,489
22
EXHIBIT A
WYETH PATENTS
CL 285,489
United States
U.S. 6,399,621 expires 8/9/2020
U.S. 4,900,836 expires 2/13/2007
U.S. 4,521,422 expires 6/23/2003
23
EXHIBIT 1.20
FORM OF STOCK PURCHASE AGREEMENT
EXHIBIT 1.20
STOCK PURCHASE AGREEMENT
This STOCK PURCHASE AGREEMENT (this "Agreement") is made and entered
into as of ________, 2004 by and among Neurocrine Biosciences, Inc., a Delaware
corporation (the "Company"), and [Wyeth Holdings Corporation (formerly known as
"American Cyanamid Company"), a Maine corporation, or its designee] (the
"Investor"). The Investor and the Company are referred to herein as the
"Parties."
W I T N E S S E T H:
WHEREAS, the Investor and the Company have entered into that certain
Assignment and License Agreement dated February __, 2004 (the "Assignment
Agreement"), which Assignment Agreement provides, inter alia, for the Parties to
enter into this Agreement, pursuant to which the Company will issue to the
Investor shares of its common stock, $.001 par value per share ("Common Stock"),
as partial consideration for the rights and obligations assigned by the Investor
to the Company under Article 2 of the Assignment Agreement and the licenses
granted by the Investor to the Company under Article 3 of the Assignment
Agreement;
WHEREAS, the Company and Investor wish to set forth certain terms
relating to the issuance of the shares of Common Stock.
NOW, THEREFORE, in consideration of the premises and the mutual
promises herein made, and in consideration of the representations, warranties
and covenants herein contained, the Parties agree as follows:
1. AGREEMENT TO ISSUE STOCK.
Subject to the terms and conditions of this Agreement, as
partial consideration for the rights and obligations assigned by the Investor to
the Company under Article 2 of the Assignment Agreement and the licenses granted
by the Investor to the Company under Article 3 of the Assignment Agreement, the
Company shall issue and deliver to the Investor at the Closing (as defined
below) Eight Hundred Two Thousand Nine Hundred Ninety-Eight (802,998) shares of
its Common Stock; provided that if the sum of the aggregate value of such shares
of Common Stock on the Closing Date (as defined below) plus the aggregate value
of any other Common Stock as of the Closing Date held by the Investor or its
Affiliate as of the Closing Date (including without limitation the 4,186 shares
of Common Stock held by the Investor or its Affiliate as of the Signature Date)
plus the aggregate value of any Common Stock as of the Closing Date purchasable
by the Investor or its Affiliate pursuant to any warrant (including without
limitation the 19,950 shares of Common Stock purchasable by the Investor or its
Affiliate under its existing warrant) is equal to or greater than $50,000,000,
the Company will (i) issue to the Investor a number of shares of Common Stock
(rounded down to the next whole share) that, when added to the number of other
shares of Common Stock held by the Investor or its Affiliate as of the Closing
Date plus the number of shares of Common Stock purchasable by the Investor or
its Affiliate pursuant to any warrant as of the Closing Date, is equal to
$49,999,995 divided by the closing sale price of the Company's Common Stock on
the Nasdaq National Market on the trading day immediately prior to the Closing
Date and (ii) pay to the
Investor an amount in cash equal to the difference of the aggregate value of
Eight Hundred Two Thousand Nine Hundred Ninety-Eight (802,998) shares of Common
Stock minus the aggregate value of the number of shares of Common Stock issuable
pursuant to this proviso. For purposes of this Section 1, the value of a number
of shares of the Company's Common Stock as of the Closing Date shall be
calculated by multiplying the number of shares by the closing sale price of the
Company's Common Stock on the Nasdaq National Market on the trading day
immediately prior to the Closing Date. The shares of the Company's Common Stock
to be issued pursuant to this Section 1 are referred to herein as the "Shares."
2. CLOSING.
The issuance and delivery of the Shares (the "Closing") will
take place at the offices of the Investor, 500 Arcola Road, Collegeville,
Pennsylvania 19426, on the date hereof (the "Closing Date").
3. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
The Company hereby represents and warrants to the Investor
that the statements in the following paragraphs of this Section 3 are true and
correct:
3.1 Organization, Good Standing and Qualification. The
Company is a corporation duly organized, validly existing and in good standing
under the laws of the State of Delaware. Schedule 3.1 attached hereto sets forth
the name and jurisdiction of organization of each of the Company's subsidiaries
("Subsidiaries"). The Company and each of its Subsidiaries are duly authorized
to conduct business and are in good standing under the laws of each jurisdiction
where such qualification is required, except where the failure to be so
qualified would not have a material adverse effect on the business, properties,
financial condition, operations or results of operations of the Company and its
Subsidiaries, taken as a whole (a "Material Adverse Effect"). Neither the
Company nor any of its Subsidiaries is in default under or in violation of any
provision of its charter or bylaws. The Company has full power and authority to
execute and deliver this Agreement and to perform its obligations hereunder. The
Company and each of the Subsidiaries have full power and authority to carry on
their respective businesses as currently conducted.
3.2 Authorization; Enforceability. All corporate action
on the part of the Company necessary for the authorization, execution and
delivery of this Agreement, the performance of the obligations of the Company at
the Closing, and the issuance and delivery of the Shares has been taken, and
this Agreement has been duly executed and delivered by the Company and
constitutes a legally valid and binding obligation of the Company, enforceable
in accordance with its terms, except as may be limited by (i) applicable
bankruptcy, insolvency, reorganization or other laws of general application
relating to or affecting the enforcement of creditors' rights generally, (ii)
the effect of rules of law governing the availability of equitable remedies and
(iii) the unenforceability under certain circumstances under law or court
decisions of provisions providing for the indemnification of or contribution to
a party with respect to a liability where such indemnification or contribution
is contrary to public policy or prohibited by law.
2
3.3 Valid Issuance of Stock. The Shares have been duly
reserved for issuance and, when issued and delivered in accordance with the
terms of this Agreement for the consideration contemplated herein, (i) will be
duly and validly issued, fully paid and nonassessable and will be free of any
taxes, liens or claims (other than those that may be created by the Investor);
(ii) will be free of any restrictions on transfer other than restrictions on
transfer under applicable federal and state securities laws; (iii) will not be
subject to preemptive rights or similar rights of any stockholders of the
Company; and (iv) will be issued in compliance with all applicable federal and
state securities laws. The Shares will have attached thereto rights (the
"Rights") to purchase Series A Participating Preferred Stock. The Rights have
been and will be issued pursuant to an Amended and Restated Preferred Shares
Rights Agreement dated as of January 11, 2002 between the Company and American
Stock Transfer & Trust Company.
3.4 Capitalization. The entire authorized capital stock
of the Company consists of 50,000,000 shares of Common Stock, of which
35,334,440 shares were issued and outstanding as of ___________, 2004, and
_________ shares of preferred stock, $.001 par value per share, none of which
are issued and outstanding as of the date hereof. Except as set forth in SEC
Documents (as defined below) and except as granted in the ordinary course of
business pursuant to the Company's 2003 Incentive Stock Plan since the dates of
the SEC Documents, there are no outstanding or authorized warrants, options,
preemptive rights, purchase rights, subscription rights, conversion rights,
exchange rights, or instruments convertible into or exchangeable for, any
unissued shares of capital stock or other equity interest in the Company, or
other contracts or commitments that could require the Company to issue, sell or
otherwise cause to become outstanding any of its capital stock. There are no
outstanding or authorized stock appreciation, phantom stock, profit
participation or similar rights with respect to the Company. Without limiting
the foregoing, no preemptive right, co-sale right, right of first refusal or
other similar right exists with respect to the issuance and sale of the Shares.
Except as set forth in the SEC Documents, there are no stockholders agreements,
voting trusts, proxies or other agreements or understandings with respect to the
voting of the capital stock of the Company.
3.5 Noncontravention. Neither the execution nor the
delivery of this Agreement, nor the consummation of the transactions
contemplated hereby, will (i) violate any constitution, statute, regulation,
rule, injunction, judgment, order, decree, ruling, charge or other restriction
of any government, governmental agency or court to which the Company is subject,
(ii) violate any provision of the charter or bylaws of the Company (the
"Governing Documents") or (iii) conflict with, result in a breach of, constitute
a default under, result in the acceleration of, create in any party the right to
accelerate, terminate, modify or cancel, or require any notice under any
agreement, contract, lease, license, instrument, or other arrangement to which
the Company is a party or by which the Company is bound or to which any of the
Company's assets is subject (or result in the imposition of any mortgage,
pledge, lien, encumbrance, charge or other security interest upon any of such
assets), except in the case of clause (i) or (iii) above, where such violation,
conflict or default would not have a Material Adverse Effect. Except for (i) the
filing of a Form D with the Securities and Exchange Commission (the "SEC") and
(ii) filings which may be required under state securities laws, the Company does
not need to give any notice to, make any filing with, or obtain any
authorization, consent or approval of any government or governmental agency in
order for the Company and the Investor to consummate the transactions
contemplated by this Agreement.
3
3.6 Reports Filed under the Securities Exchange Act of
1934; Financial Statements. The Company has timely filed or furnished, as
applicable, all reports required to be filed by the Company under the Securities
Exchange Act of 1934, as amended (the "1934 Act"), and the related
certifications required under Sections 302 and 906 of the Sarbanes-Oxley Act of
2002. All such reports filed by the Company in the preceding twelve (12) months
(the "SEC Documents") contain all statements required to be stated therein in
accordance with the 1934 Act and the rules and regulations promulgated
thereunder applicable to the SEC Documents, and the SEC Documents do not contain
any untrue statement of a material fact or omit to state a material fact
required to be stated therein or necessary to make the statements therein not
misleading. Any statements made in any such SEC Documents that are or were
required to be updated or amended have been so updated or amended. As of their
respective dates (except as they have been correctly amended), the financial
statements of the Company included in the SEC Documents complied as to form in
all material respects with applicable accounting requirements and the published
rules and regulations of the SEC with respect thereto. Such financial statements
have been prepared in accordance with generally accepted accounting principles,
consistently applied, during the periods involved (except (a) as may be
otherwise indicated in such financial statements or the notes thereto or (b) in
the case of unaudited interim statements, to the extent they may exclude
footnotes or may be condensed or summary statements) and fairly present the
financial position of the Company as of the dates thereof and the results of its
operations and cash flows for the periods then ended (subject, in the case of
unaudited statements, to normal year-end audit adjustments). Except as set forth
in the SEC Documents, the Company has no liabilities, contingent or otherwise,
other than (i) liabilities incurred in the ordinary course of business
subsequent to the date of such SEC Documents, (ii) obligations under contracts
and commitments incurred in the ordinary course of business and not required
under generally accepted accounting principles to be reflected in such SEC
Documents, which liabilities and obligations referred to in clauses (i) and
(ii), individually or in the aggregate, would not have a Material Adverse
Effect, and (iii) contingent liabilities which, individually or in the
aggregate, could not reasonably be expected to have a Material Adverse Effect.
3.7 Absence of Litigation. Except as disclosed in the SEC
Documents, there is no action, suit, proceeding, inquiry or investigation before
or by any court, public board, government agency, self-regulatory organization
or body pending or, to the knowledge of the Company, threatened against or
affecting the Company, or any of its Subsidiaries, or any of their directors or
officers in their capacities as such which could reasonably be expected to have
a Material Adverse Effect.
3.8 Taxes. The Company has filed all tax returns,
reports, forms, schedules and any other documents ("Tax Returns") required to be
filed by or on behalf of the Company, and all such Tax Returns are accurate and
complete in all material respects. The Company has paid all material taxes
(including interest, penalties, additions to tax or other additional amounts
imposed by any taxing authority) shown to be due on such Tax Returns or
otherwise due, except for such taxes that are being contested in good faith and
for which adequate reserves have been provided.
3.9 No Violations. The Company is not in violation of its
charter, bylaws or other organizational documents, or in violation of any law,
administrative regulation, ordinance
4
or order of any court or governmental agency, arbitration panel or authority
applicable to the Company, which violation, individually or in the aggregate,
would be reasonably likely to have a Material Adverse Effect, and is not in
default (and there exists no condition which, with or without the passage of
time or giving of notice or otherwise, would constitute a default) in the
performance of any bond, debenture, note or any other evidence of indebtedness
in any indenture, mortgage, deed of trust or any other agreement or instrument
to which the Company is a party or by which the Company is bound or by which the
property of the Company is bound, which would be reasonably likely to have a
Material Adverse Effect.
3.10 Nasdaq Compliance. The Common Stock is registered
pursuant to Section 12(g) of the 1934 Act, and is listed on the Nasdaq National
Market, and the Company has taken no action designed to, or likely to have the
effect of, terminating the registration of the Common Stock under the 1934 Act
or delisting the Common Stock from the Nasdaq National Market.
3.11 No Manipulation of Stock. The Company has not taken
any action outside the ordinary course of business designed to or that might
reasonably be expected to cause or result in stabilization or manipulation of
the price of the Common Stock to facilitate the sale or resale of the Shares.
3.12 No General Solicitation. Neither the Company, nor any
of its affiliates, nor any person acting on its or their behalf, has engaged in
any form of general solicitation or general advertising (within the meaning of
Regulation D under the Securities Act of 1933, as amended (the "1933 Act")) in
connection with the offer or sale of the Shares.
3.13 Form S-3 Eligibility. The Company is currently, and
at the Closing Date will be, eligible to register the resale of the Shares on a
registration statement on Form S-3 under the 1933 Act. There exist no facts or
circumstances (including without limitation any required approvals or waivers of
any circumstances that may delay or prevent the obtaining of accountant's
consents) that would prohibit or delay the preparation and filing of a
registration statement on Form S-3 with respect to the Shares.
3.14 Rule 144 Availability. The Company has filed the
reports required to be filed by it under the 1934 Act and the rules and
regulations adopted by the SEC thereunder in order to enable the holders of
unregistered Common Stock to sell such Common Stock without registration under
the 1933 Act within the limitation of the exemptions provided by Rule 144 under
the 1933 Act, as such Rule is currently in effect.
4. REPRESENTATIONS AND WARRANTIES OF THE INVESTOR.
The Investor represents and warrants to the Company that the
statements in the following paragraphs of this Section 4 are true and correct:
4.1 Organization and Qualification. The Investor is a
corporation duly organized, validly existing and in good standing under the laws
of the State of [Maine]. The Investor has all requisite corporate power and
authority to enter into and perform this Agreement and to carry out the
transactions contemplated by this Agreement.
5
4.2 Authorization. All action on the part of the Investor
necessary for the authorization, execution and delivery of this Agreement and
the performance of all obligations of the Investor hereunder has been taken, and
this Agreement has been duly executed and delivered by the Investor and
constitutes a legally valid and binding obligation of the Investor, enforceable
in accordance with its terms, except as may be limited by (i) applicable
bankruptcy, insolvency, reorganization or other laws of general application
relating to or affecting the enforcement of creditors' rights generally, (ii)
the effect of rules of law governing the availability of equitable remedies and
(iii) the unenforceability under certain circumstances under law or court
decisions of provisions providing for the indemnification of or contribution to
a party with respect to a liability where such indemnification or contribution
is contrary to public policy or prohibited by law.
4.3 Purchase for Own Account. The Shares to be purchased
by the Investor hereunder will be acquired for investment for the Investor's own
account, not as a nominee or agent, and not with a view to the public
distribution thereof within the meaning of the 1933 Act, and the Investor has no
present intention of selling or otherwise distributing the same, except in
compliance with the requirements of, or pursuant to a valid exemption from, such
Act. The Investor does not have any contract, undertaking, agreement or
arrangement with any person to sell, transfer or grant participations to such
person or to any third person, with respect to the Shares. The Investor also
represents that it has not been formed for the specific purpose of acquiring the
Shares.
4.4 Accredited Investor Status. The Investor is an
"accredited investor" within the meaning of Regulation D promulgated under the
1933 Act. By reason of its business and financial experience, sophistication and
knowledge, the Investor is capable of evaluating the risks and merits of the
investment made pursuant to this Agreement. The Investor confirms that it is
able (i) to bear the economic risk of this investment, (ii) to hold the Shares
for an indefinite period of time, and (iii) to bear a complete loss of the
Investor's investment; and the Investor represents that it has sufficient liquid
assets so that the illiquidity associated with this investment will not cause
any undue financial difficulties or affect the Investor's ability to provide for
its current needs and possible financial contingencies.
4.5 Restricted Securities. The Investor understands that
the Shares are characterized as "restricted securities" under the 1933 Act
inasmuch as they are being acquired from the Company in a transaction not
involving a public offering and that under the 1933 Act and applicable
regulations thereunder such securities may be resold without registration under
the 1933 Act only in certain limited circumstances. In this connection, the
Investor represents that it is familiar with SEC Rule 144, as presently in
effect, and understands the resale limitations imposed thereby and by the 1933
Act. The Investor understands that the Company is under no obligation to
register any of the securities sold hereunder, except as provided in Section 7
below.
4.6 Due Diligence and No Solicitation. The Investor has
had a reasonable opportunity to conduct due diligence and to ask questions of
and receive answers from the Company and its officers. At no time was the
Investor presented with or solicited by any leaflet, public promotional meeting,
circular, newspaper or magazine article, radio or television advertisement or
any other form of general advertising. Neither such inquiries nor any other due
6
diligence investigation conducted by Investor or its counsel or any of its
representatives shall modify or affect Investor's right to rely on the Company's
representations and warranties in this Agreement.
4.7 Further Limitations on Disposition. The Investor
further agrees not to make any disposition of all or any portion of the Shares
unless and until:
(a) there is then in effect a registration
statement under the 1933 Act covering such proposed disposition and such
disposition is made in accordance with such registration statement; or
(b) (i) the Investor shall have notified the
Company of the proposed disposition and shall have furnished the Company with a
statement of the circumstances surrounding the proposed disposition, which in
the case of a sale to be made pursuant to Rule 144 shall be limited to customary
representations regarding compliance with the requirements of Rule 144 regarding
volume, manner of sale and other matters, and (ii) the Investor shall have
furnished the Company at the Investor's expense an opinion of in house or
outside counsel (as determined by the Investor), reasonably satisfactory to the
Company that such disposition will not require registration of such securities
under the 1933 Act; provided that the Company shall not require an opinion of
counsel for routine sales of shares pursuant to Rule 144 or any sale of shares
pursuant to Rule 144(k).
Notwithstanding the foregoing provisions of this Section 4.7
or any other provision of this Article 4 or this Agreement, the Parties
acknowledge and agree that the Investor may contribute or otherwise transfer the
Shares without consideration to a corporation that is the direct or indirect
parent of the Investor or to any subsidiary of the Investor or such corporate
parent.
4.8 Legends. It is understood that the certificates
evidencing the Shares will bear the legends set forth below:
(a) THE SECURITIES REPRESENTED HEREBY HAVE NOT
BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "ACT"), OR
UNDER THE SECURITIES LAWS OF ANY STATE. THESE SECURITIES ARE SUBJECT TO
RESTRICTIONS ON TRANSFERABILITY AND RESALE AND MAY NOT BE TRANSFERRED OR RESOLD
EXCEPT AS PERMITTED UNDER THE ACT AND THE APPLICABLE STATE SECURITIES LAWS,
PURSUANT TO REGISTRATION OR EXEMPTION THEREFROM.
(b) Any legend required by the laws of the State
of California, including any legend required by the California Department of
Corporations.
The legend set forth above shall be removed and the Company shall issue a
certificate without such legend to the holder of Shares upon which it is
stamped, if (a) the Shares represented by such certificate have been sold
pursuant to an effective registration statement under the 1933 Act or (b) in
connection with the resale of such Shares, such holder provides the Company with
an opinion of in house or outside counsel (as determined by the Investor), in
form, substance and
7
scope customary for opinions of counsel in comparable transactions, to the
effect that a public sale or transfer of such Security may be made without
registration under the 1933 Act or (c) such holder provides the Company with
reasonable assurances that such Shares have been sold under Rule 144 or can be
sold under Rule 144(k).
5. COVENANTS.
The Company and the Investor agree as follows:
5.1 Form D. The Company agrees to file a notice of sale
on Form D with respect to the Shares as required under Regulation D promulgated
under the 1933 Act and to provide a copy thereof to Investor promptly after such
filing.
5.2 No Integrated Offerings. The Company shall not make
any offers or sales of any security (other than the Shares) under circumstances
that would require registration of the Shares being offered or sold hereunder
under the 1933 Act or cause this offering of Shares to be integrated with any
other offering of securities by the Company.
5.3 Transfer Taxes. On the Closing Date, all stock
transfer or other taxes (other than income taxes) which are required to be paid
in connection with the sale and transfer of the Shares to be sold to the
Investor hereunder will be, or will have been, fully paid or provided for by the
Company and all laws imposing such taxes will be or will have been fully
complied with.
6. DELIVERIES BY THE COMPANY AT CLOSING.
At the Closing, the Company shall deliver, or cause to be
delivered, to the Investor the following:
6.1 Stock Certificate. A certificate representing the
Shares.
6.2 Opinion of Company Counsel The Investor shall have
received a customary opinion of Latham & Watkins LLP, outside counsel to the
Company, with respect to the matters set forth on Exhibit A and a customary
legal opinion of Margaret E. Valeur-Jensen, Esq., the Company's General Counsel,
addressed to the Investor with respect to the matters set forth on Exhibit B.
7. REGISTRATION STATEMENT FOR RESALE OF THE SHARES.
7.1 Demand Registration Rights. As promptly as
practicable but in no event later than thirty (30) days after the receipt of a
written request from the Investor that the Company effect any registration under
the 1933 Act on SEC Form S-3 (or any successor form to Form S-3 regardless of
its designation) at a time when the Company is eligible to register securities
on Form S-3 (or any successor form to Form S-3 regardless of its designation),
the Company will prepare and file with the SEC a registration statement on Form
S-3 (or any successor form to Form S-3 regardless of its designation)
registering all of the Shares sold to the Investor pursuant to this Agreement
for resale to the public by the Investor pursuant to such
8
registration statement (the "Shelf Registration Statement") and the prospectus
included therein, free and clear of any restrictions under the 1933 Act except
for prospectus delivery requirements. For purposes of this Section 7, the term
"Shares" shall be deemed to include shares of Common Stock issued as a dividend
or other distribution with respect to or in replacement of the Shares. The
Company shall use its reasonable best efforts to cause the Shelf Registration
Statement to become effective as promptly as practicable thereafter and, subject
to Sections 7.3(c), to remain effective until the earlier of (i) ninety (90)
days from the effective date and (ii) such time as the Investor has sold all of
the Shares (the "Registration Period"). Notwithstanding the foregoing, (1) the
Company shall have no obligation to prepare and file, or maintain the
effectiveness of, a Shelf Registration Statement at any time that the Investor
may sell all or any portion of the Shares pursuant to SEC Rule 144(k); (2) the
Company shall have the right to defer the filing of a Shelf Registration
Statement for a period of not more than sixty (60) days from delivery of the
request of the Investor if within seven (7) days from delivery of such request
the Company notifies the Investor of the Company's intention to make a public
offering within sixty (60) days or the Company notifies the Investor that, in
the good faith determination of the Board of Directors of the Company, it would
be seriously detrimental to the Company for any registration to be effected as
requested under this Section 7.1; provided, however, that the Company may not
utilize this right more than once; and (3) the Company shall have no obligation
to enter into an underwriting agreement relating to, or otherwise facilitate, an
underwritten sale of the Shares pursuant to the Shelf Registration Statement.
7.2 Piggyback Registration Rights.
(a) Right to Piggyback. If, at any time during
the period commencing upon the Closing Date and ending upon the one-year
anniversary of the Closing Date, the Company proposes to register any shares of
Common Stock with the SEC under the 1933 Act in connection with the underwritten
public offering of such shares, and the registration form to be used may be used
for the registration of the Shares (a "Piggyback Registration"), the Company (1)
will give written notice (the "Piggyback Notice") to the Investor no later than
ten (10) days prior to the anticipated filing date of its intention to effect
such a registration, which Piggyback Notice will specify the kind and number of
securities proposed to be registered, the distribution arrangements and such
other information that at the time would be appropriate to include in such
notice, and (2) will, subject to Section 7.2(b), include in such Piggyback
Registration all Shares with respect to which the Company has received written
requests for inclusion therein within five (5) days after the date of the
Piggyback Notice. Subject to Section 7.2(b), such Shares shall be included in
the underwriting on the same terms and conditions as the securities otherwise
being sold through the underwriters. The Investor's right to registration of any
Shares pursuant to this Section 7.2 shall be conditioned on the inclusion of
such Shares in such underwriting, and the Investor shall have no right to
participate in the selection of the underwriters for such offering.
(b) Priority on Piggyback Registrations. If the
managing underwriter or underwriters in any Piggyback Registration advise the
Company that in its or their reasonable good faith opinion the number or kind of
securities proposed to be sold in such registration (including Shares to be
included pursuant to Section 7.2(a)) is inconsistent with that which can be sold
in such registration without having a material adverse effect on the success of
the offering, the Company will include in such registration the number of
securities, if any, which, in
9
the opinion of such underwriter or underwriters can be sold, in the following
order of priority: (1) first, the shares the Company proposes to sell for its
own account, (2) second, the Shares requested to be included in such
registration by the Investor and other holders of similar piggyback registration
rights, and (3) third, any securities held by any other persons to be included
in such Piggyback Registration.
7.3 Company Obligations. In connection with the
registration of the Shares pursuant to this Section 7, the Company shall do the
following:
(a) Prepare and deliver to the Investor as many
copies of the Prospectus (as hereafter defined) as the Investor may reasonably
request;
(b) With respect to the Shelf Registration
Statement contemplated by Section 7.1, use its reasonable best efforts to comply
with all requirements imposed upon it by the 1933 Act, by the 1934 Act and by
the undertakings in the Shelf Registration Statement, so far as is necessary to
permit the continuance of resales of the Shares by the Investor to the public,
free and clear of any restrictions under the 1933 Act except for prospectus
delivery requirements;
(c) If an event shall occur which makes it
necessary to amend or supplement any registration statement filed pursuant to
this Section 7 (any such registration statement, including the Shelf
Registration Statement, the "Registration Statement") or the Prospectus to
comply with law or with the rules and regulations of the SEC, the Company shall
promptly notify the Investor of the proposed amendment or supplement and
promptly prepare and furnish to the Investor such number of copies of an amended
or supplemented Registration Statement and/or Prospectus that complies with law
and with such rules and regulations as the Investor may reasonably request. The
Investor shall suspend its sales of the Shares pending the preparation and
delivery of such amendment or supplement and until such time as each such
amendment or amendments to the Registration Statement have been declared
effective by the SEC. The Company authorizes the Investor, and any brokers or
dealers effecting sales of the Shares for the account of the Investor, to use
the Prospectus, as from time to time amended or supplemented, in connection with
the sale of the Shares in accordance with applicable provisions of the 1933 Act
and state securities laws. For purposes of this Agreement, the term "Prospectus"
means the final prospectus relating to the Shares most recently included in the
Registration Statement or filed by the Company pursuant to Rule 424 of the 1933
Act and any amendments or supplements thereto filed by the Company pursuant to
Rule 424 of the 1933 Act and shall include all documents or information
incorporated in any such prospectus by reference;
(d) Promptly advise the Investor (i) when any
post-effective amendment of the Registration Statement is filed with the SEC and
when any post-effective amendment becomes effective; (ii) of any request made by
the SEC for any amendment of or supplement to the Registration Statement or the
Prospectus or for additional information relating thereto; (iii) of any
suspension or threatened suspension of the use of any Prospectus in any state;
and (iv) of any proceedings commenced or threatened to be commenced by the SEC
or any state securities commission that would result in the issuance of any stop
order or other order or suspension of use. The Company agrees to use its
reasonable best efforts to prevent or promptly remove any stop order or other
order preventing or suspending the use of the Prospectus during any period
during which the Company has an obligation to maintain the effectiveness of a
10
Registration Statement filed pursuant to this Section 7 (the "Resale Period")
and to comply with any such request by the SEC to amend or supplement the
Prospectus;
(e) Take such action as shall be necessary to
qualify and maintain the qualification of the Shares covered by such
registration under such state securities or "blue sky" laws for offers and sales
to the public during the Resale Period as the Investor shall reasonably request;
provided, however, that the Company shall not be obligated to qualify as a
foreign corporation to do business under the laws of or become subject to
taxation in, any jurisdiction in which it shall not be then qualified, or to
file any general consent to service of process;
(f) Provide a transfer agent and registrar,
which may be a single entity, for the Shares not later than the effective date
of the Registration Statement;
(g) Prepare and file with the SEC, at the
request of the Investor, such amendments (including post-effective amendments)
and supplements to a Shelf Registration Statement and the prospectus used in
connection therewith as may be reasonably necessary or appropriate to change the
plan of distribution set forth in the Shelf Registration Statement; and
(h) Cause the Common Stock to be registered
pursuant to Section 12(b) or 12(g) of the 1934 Act and continually quoted or
listed, subject to notice of issuance, on the Nasdaq National Market or a
national securities exchange, if such exchange is the principal market on which
the Common Stock is traded, and not subject to any restriction or suspension
from trading on the Nasdaq National Market or such national securities exchange;
provided, however, that the Company may deregister the Common Stock registered
pursuant to Section 12(b) or 12(g) of the 1934 Act if such deregistration is in
connection with a merger, dissolution or other transaction in which the
stockholders of the Company receive prior to such deregistration either cash or
securities that are listed on the Nasdaq National Market or a national
securities exchange or some combination of cash and such securities; provided,
further, that the Company may delist the Common Stock from trading on the Nasdaq
National Market or national securities exchange if the Company is concurrently
listing such stock on the New York Stock Exchange or the American Stock
Exchange.
(i) With a view to making available to the
Investor the benefits of certain rules and regulations of the SEC that at any
time permit the sale of the Shares to the public without registration, the
Company agrees to:
(A) make and keep public information
available, as those terms are understood and defined in Rule 144 under the 1933
Act;
(B) file with the SEC in a timely
manner all reports and other documents required of the Company under the 1934
Act; and
(C) so long as the Investor owns any
unregistered Shares, furnish to the Investor upon any reasonable request a
written statement by the Company as to its compliance with the public
information requirements of Rule 144 under the 1933 Act, and of the 1934 Act, a
copy of the most recent annual or quarterly report of the Company, and the other
SEC reports and documents of the Company as the Investor may reasonably request
in availing
11
itself of any rule or regulation of the SEC allowing an Investor to sell any
Shares without registration (excluding any reports or documents of the Company
that the Company, in its sole discretion, deems confidential).
7.4 Restrictions on Registrations. If at any time or from
time to time after the effective date of the Registration Statement, the Company
notifies the Investor in writing of the existence of a Material Event (as
defined below), the Investor shall not offer or sell any Shares or engage in any
other transaction involving or relating to Shares from the time of the giving of
notice with respect to a Material Event until the Investor receives written
notice from the Company that such Material Event either has been disclosed to
the public or no longer constitutes a Material Event. "Material Event" means any
of the following: (i) the possession by the Company of material information not
ripe for disclosure in the Registration Statement, as determined in good faith
by the Board of Directors of the Company that disclosure of such information in
the Registration Statement at such time would be seriously detrimental to the
business and affairs of the Company; or (ii) any material engagement or activity
by the Company which would, in the good faith determination of the Board of
Directors of the Company, be seriously adversely affected by disclosure in the
Registration Statement at such time, which determination shall be accompanied by
a good faith determination by the Board of Directors of the Company that the
Registration Statement would be materially misleading absent the inclusion of
such information. In no event shall the suspension of the Registration Statement
(or the permissible delay in filing the Registration Statement) exceed sixty
(60) days as a result of a Material Event.
7.5 Certain Obligations of Investor. In connection with
the registration of the Shares pursuant to this Section 7:
(a) The Investor shall cooperate as reasonably
requested by the Company with the Company in connection with the preparation of
the Registration Statement, and for so long as the Company is obligated to file
and keep effective the Registration Statement, shall provide to the Company, in
writing, for use in the Registration Statement, all such information regarding
such Investor and its plan of distribution of the Shares as may be required to
enable the Company to prepare the Registration Statement and the Prospectus, to
maintain the currency and effectiveness thereof and otherwise to comply with all
applicable requirements of law in connection therewith.
(b) The Investor agrees to promptly furnish
additional information required to be disclosed in order to make the information
previously furnished to the Company by the Investor not materially misleading.
The Investor agrees to furnish all such information and to cooperate with and
provide assistance to the Company, as the Company may reasonably request, in
connection with any registration and sale of the Shares.
(c) The Investor hereby covenants with the
Company not to make any sale of the Shares without effectively causing the
prospectus delivery requirements under the 1933 Act to be satisfied unless the
sale is made pursuant to an exemption from registration.
(d) The Investor acknowledges and agrees that
the Shares sold pursuant to the Registration Statement are not transferable on
the books of the Company unless
12
the stock certificate submitted to the transfer agent evidencing the Shares is
accompanied by a certificate reasonably satisfactory to the Company to the
effect that (i) the Shares have been sold in accordance with this Agreement and
the Registration Statement and (ii) the requirement of delivering a current
prospectus has been satisfied.
(e) The Investor is hereby advised that the
anti-manipulation provisions of Regulation M under the 1934 Act may apply to
sales of the Shares offered pursuant to the Registration Statement and agrees
not to take any action with respect to any distribution deemed to be made
pursuant to the Registration Statement that constitutes a violation of
Regulation M under the 1934 Act or any other applicable rule, regulation or law.
(f) At the end of the Registration Period, the
Investor shall discontinue sales of Shares pursuant to the Shelf Registration
Statement upon receipt of notice from the Company of its intention to remove
from registration the Shares covered thereby which remain unsold, and the
Investor shall promptly notify the Company of the number of Shares registered
that remain unsold immediately upon receipt of the notice from the Company.
7.6 Indemnification of the Investor. The Company shall
indemnify, defend and hold harmless the Investor, its officers and its directors
and any controlling persons of the Investor against and in respect of any
losses, claims, damages or liabilities, joint or several (including legal or
other fees and expenses reasonably incurred by any of them in connection with
investigating or defending any such loss, claim, damage or liability) to which
the Investor or any such persons may become subject under the 1933 Act or
otherwise insofar as such losses, claims, damages or liabilities (or actions
with respect thereto) arise out of or are based upon any untrue statement or
alleged untrue statement of any material fact contained in the Registration
Statement or Prospectus, or arise out of or are based upon the omission or
alleged omission to state therein a material fact required to be stated therein
or necessary to make the statements therein not misleading, except to the extent
that any such untrue statement or omission is based upon written information
supplied by the Investor or by any of its representatives for use specifically
in such Registration Statement; provided, however, this indemnity agreement
shall not inure to the benefit of the Investor to the extent any loss, claim,
damage, liability or action arising from the sale of the Shares to any person
results from the Investor failing to send or give a copy of the Prospectus (as
amended or supplemented) to such person.
7.7 Indemnification of the Company. The Investor shall
indemnify, defend and hold harmless the Company, its officers and its directors
and any controlling persons of the Company against and in respect of any losses,
claims, damages or liabilities, joint or several (including legal or other fees
and expenses reasonably incurred by any of them in connection with investigating
or defending any such loss, claim, damage or liability) to which the Company or
any such persons may become subject under the 1933 Act or otherwise insofar as
such losses, claims, damages or liabilities (or actions with respect thereto)
arise out of or are based upon any untrue statement or alleged untrue statement
of any material fact contained in the Registration Statement, or arise out of or
are based upon the omission or alleged omission to state therein a material fact
required to be stated therein or necessary to make the statements therein not
misleading, but only in each case to the extent that any such untrue statement
or omission is based upon written information supplied by the Investor or its
representatives for use specifically
13
in such Registration Statement; provided that in no event shall any
indemnification obligation on the part of the Investor under this Section 7.7
exceed the net proceeds from the offering received by the Investor.
7.8 Contribution. If for any reason the indemnification
provided for in the preceding Sections 7.6 or 7.7 is unavailable to an
indemnified party as contemplated by such clauses, then the indemnifying party
shall contribute to the amount paid or payable by the indemnified party as a
result of such loss, claim, damage or liability in such proportion as is
appropriate to reflect not only the relative benefits received by the
indemnified party and the indemnifying party, but also the relative fault of the
indemnified party and the indemnifying party, as well as any other relevant
equitable considerations; provided that in no event shall any contribution
obligation on the part of the Investor under this Section 7.8 exceed the net
proceeds from the offering received by the Investor.
7.9 Procedure for Indemnification. The procedure for
indemnification under this Section 7 shall be as follows:
(a) Notice. The indemnified party shall promptly
give notice to the indemnifying party of any pending or threatened claim giving
rise to indemnification under Sections 7.6 or 7.7 (a "Claim"), specifying the
factual basis for the Claim and the approximate amount thereof.
(b) Control of Claim and Settlement. With
respect to any Claim as to which a person is entitled to indemnification
hereunder, the indemnifying party shall have the right at its own expense to
participate in or assume control of the defense of the Claim, and the
indemnified party shall reasonably cooperate with the indemnifying party,
subject to reimbursement for actual out-of-pocket expenses incurred by the
indemnified party as the result of a request by the indemnifying party;
provided, however, that such indemnifying party shall not be entitled to assume
such defense and an indemnified party shall have the right to retain its own
counsel with the reasonable fees and expenses to be paid by the indemnifying
party, if, in the reasonable opinion of counsel retained by the indemnifying
party, the representation by such counsel of the indemnified party and the
indemnifying party would be inappropriate due to actual or potential conflicts
of interest between such indemnified party and any other party represented by
such counsel in such proceeding or the actual or potential defendants in, or
targets of, any such action include both the indemnified party and the
indemnifying party and any such indemnified party reasonably determines that
there may be legal defenses available to such indemnified party which are in
conflict with those available to such indemnifying party. If the indemnifying
party elects to assume control of the defense of any Claim, the indemnified
party shall have the right to participate in the defense of the Claim at its own
expense. If the indemnifying party does not elect to assume control or otherwise
participate in the defense of any Claim, it shall be bound by the results
obtained by the indemnified party with respect to the Claim. No indemnifying
party shall be liable for any settlement effected without its written consent,
not to be unreasonably withheld or delayed.
(c) Survival. Notwithstanding any other
provision of this Agreement, the indemnification and contribution obligations of
the parties hereunder shall survive indefinitely.
14
7.10 Expenses. The Company shall pay all expenses incident
to the registration of the Shares under this Section 7, including without
limitation, all registration and filing fees, all fees and expenses of complying
with securities or blue sky laws, all word processing, duplicating and printing
expenses, and the fees and disbursements of counsel for the Company and its
independent public accountants. With respect to sales of the Shares, the
Investor shall pay all underwriting discounts and commissions and fees of
underwriters, selling brokers, dealer managers or similar securities industry
professionals relating to any resale of the Shares by the Investor, and transfer
taxes, if any.
7.11 Compliance. The Investor will observe and comply with
the 1933 Act, the 1934 Act and the general rules and regulations thereunder, as
now in effect and as from time to time amended and including those hereafter
enacted or promulgated, in connection with any offer, sale, pledge, transfer or
other disposition of the Shares or any part thereof.
8. MISCELLANEOUS.
8.1 Survival of Warranties. The representations and
warranties of the Company and the Investor contained in or made pursuant to this
Agreement shall survive the execution and delivery of this Agreement, the
Closing and the delivery to the Investor of the Shares and shall in no way be
affected by any investigation of the subject matter thereof made by or on behalf
of the Investor or the Company, as the case may be; provided, however, that (a)
the representations and warranties in Sections 3.1, 3.2, 3.3, 4.1 and 4.2 shall
survive without limitation to time, (b) the representations and warranties set
forth in Section 3.8 shall survive until fifteen (15) months after the Closing
Date and (c) all other representations and warranties in Articles 3 and 4 shall
survive until one (1) year after the Closing Date. The covenants of the Company
and the Investor contained in or made pursuant to this Agreement shall survive
the execution and delivery of this Agreement, the Closing and the delivery to
the Investor of the Shares and shall survive indefinitely.
8.2 Successors and Assigns. This Agreement shall bind and
inure to the benefit of the Company and the Investor and their respective
successors and permitted assigns; provided that the Company may not assign its
rights or obligations under this Agreement to any person without the prior
written consent of the Investor; provided, further, that the Investor may not
assign its rights or obligations under this Agreement to any person (other than
an affiliate) without the prior written consent of the Company. For the
avoidance of doubt, the Parties agree that the Investor may contribute or
otherwise transfer the Shares to any affiliate.
8.3 Applicable Law. This Agreement is governed by, and
shall be construed in accordance with, the laws of the State of California,
United States of America.
8.4 Counterparts. This Agreement may be executed in two
or more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
8.5 Headings. The headings and captions used in this
Agreement are used for convenience only and are not to be considered in
construing or interpreting this Agreement. All references in this Agreement to
sections, paragraphs, exhibits and schedules shall, unless
15
otherwise provided, refer to sections and paragraphs hereof and exhibits and
schedules attached hereto, all of which exhibits and schedules are incorporated
herein by this reference.
8.6 Notices. All notices, requests, demands, claims and
other communications hereunder will be in writing. Any notice, request, demand,
claim or other communication hereunder shall be deemed duly given if (within two
business days) it is sent by registered or certified mail, return receipt
requested, postage prepaid and addressed to the intended recipient as set forth
below:
To the Company: Neurocrine Biosciences, Inc.
10555 Science Center Drive
San Diego, CA 92121
Attention: Margaret Valeur-Jensen, Esq.
Telephone: (858) 658-7600
Facsimile: (858) 658-7605
with a copy to: Latham & Watkins LLP
12636 High Bluff Drive, Suite 300
San Diego, CA 92130
Attn: Scott N. Wolfe, Esq.
Telephone: (858) 523-5400
Facsimile: (858) 523-5450
To the Investor: [Wyeth Holdings Corporation]
500 Arcola Road
Collegeville, PA 19426
Attention: Senior Vice President, Worldwide
Licensing
Facsimile: (484) 865-9301
with a copy to: Wyeth
5 Giralda Farms
Madison, NJ 07940
Attention: General Counsel
Facsimile: (973) 660-7156
Any Party may send any notice, request, demand, claim or other communication
hereunder to the intended recipient at the address set forth above using any
other means (including personal delivery, expedited courier, messenger service
or ordinary mail), but no such notice, request, demand, claim or other
communication shall be deemed to have been duly given unless and until it
actually is received by the intended recipient. Any Party may change the address
to which notices, requests, demands, claims and other communications hereunder
are to be delivered by giving the other Parties notice in the manner herein set
forth.
8.7 No Finder's Fees. Each of the Company and the
Investor represents that it neither is nor will be obligated for any finder's or
broker's fee or commission in connection with this transaction. The Company
agrees to indemnify and hold harmless the Investor from any
16
liability for any commission or compensation in the nature of a finder's or
broker's fee (and any asserted liability) for which the Company or any of its
officers, employees or representatives is responsible.
8.8 Amendments and Waivers. Any term of this Agreement
may be amended and the observance of any term of this Agreement may be waived
(either generally or in a particular instance and either retroactively or
prospectively) only with the written consent of the Company and the Investor.
8.9 Severability. If one or more provisions of this
Agreement are held to be unenforceable under applicable law, such provision(s)
shall be excluded from this Agreement and the balance of the Agreement shall be
interpreted as if such provision(s) were so excluded and shall be enforceable in
accordance with its terms.
8.10 Entire Agreement. This Agreement, together with all
exhibits and schedules hereto, constitutes the entire agreement and
understanding of the parties with respect to the subject matter hereof and
supersedes any and all prior negotiations, correspondence, agreements,
understandings, duties or obligations between the parties with respect to the
subject matter hereof.
8.11 Public Announcements. The Investor and the Company
shall use reasonable efforts to consult with each other before issuing any press
release with respect to this Agreement or the transactions contemplated hereby
and neither shall issue any such press release or make any such public statement
without the prior consent of the other, which consent shall not be unreasonably
withheld or delayed; provided, however, that a Party may, without the prior
consent of the other Party, issue such press release or make such public
statement as may upon the advice of counsel be required by law if it has used
reasonable efforts to consult with the other Party prior thereto. The Investor
hereby consents to the filing of this Agreement by the Company with the SEC.
8.12 Further Assurances. From and after the date of this
Agreement, upon the request of the Investor or the Company, the Company and the
Investor shall execute and deliver such instruments, documents or other writings
as may be reasonably necessary or desirable to confirm and carry out and to
effectuate fully the intent and purposes of this Agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
17
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
THE COMPANY:
NEUROCRINE BIOSCIENCES, INC.
By:
Name:
Title:
THE INVESTOR:
[WYETH HOLDINGS CORPORATION]
By:
Name:
Title:
EXHIBIT A
FORM OF OPINION OF LATHAM & WATKINS
1. The Company is a corporation under the General Corporation Law
of the State of Delaware, with corporate power and authority to own its
properties and to conduct its business as described in the SEC Documents. Based
on certificates from public officials, we confirm that the Company is validly
existing and in good standing under the laws of the State of Delaware and is
qualified to do business in the State of California.
2. The authorized capital stock of the Company consists of (a)
50,000,000 shares of Common Stock, and (b) 5,000,000 shares of preferred stock,
par value $0.001 per share. The Shares have been duly authorized by all
necessary corporate action of the Company and, when issued to you in accordance
with the terms of the Purchase Agreement, will be validly issued, fully paid and
nonassessable and free of preemptive rights arising from the Governing
Documents.
3. The execution, delivery and performance of the Purchase
Agreement have been duly authorized by all necessary corporate action of the
Company, and the Purchase Agreement has been duly executed and delivered by the
Company. The Purchase Agreement constitutes a legally valid and binding
obligation of the Company, enforceable against the Company in accordance with
its terms.
4. The execution and delivery of the Purchase Agreement and the
issuance and sale of the Shares by the Company to you pursuant to the Purchase
Agreement on the date hereof do not:
(a) violate the Company's Governing Documents;
(b) violate any federal or California statute, rule or
regulation applicable to the Company; or
(c) require any consents, approvals or authorizations to
be obtained by the Company, or any registrations,
declarations or filings to be made by the Company, in
each case, under any federal or California statute,
rule or regulation applicable to the Company, except
such that have been obtained under the Securities Act
and such that may be required under state securities
laws.
5. Assuming the accuracy of the representations in Section 4 of
the Purchase Agreement, no registration of the Shares under the Securities Act
of 1933, as amended (the "Securities Act"), is required in connection with the
issuance of the Shares to the Investor in the manner contemplated by the
Purchase Agreement.
The opinions expressed in paragraph 3 shall be further subject to the
following limitations, qualifications and exceptions:
1
(a) the effect of bankruptcy, insolvency, reorganization,
fraudulent transfer, moratorium or other similar laws relating to or
affecting the rights or remedies of creditors;
(b) the effects of general principles of equity, whether
considered in a proceeding in equity or at law (including the possible
unavailability of specific performance or injunctive relief), concepts
of materiality, reasonableness, good faith and fair dealing, and the
discretion of the court before which a proceeding is brought;
(c) the unenforceability under certain circumstances
under law or court decisions of provisions for the indemnification of
or contribution to a party with respect to a liability where such
indemnification or contribution is contrary to public policy;
(d) certain rights, remedies and waivers contained in the
Purchase Agreement may be limited or rendered ineffective by applicable
California laws or judicial decisions governing such provisions, but
such laws or judicial decisions do not render the Purchase Agreement
invalid or unenforceable as a whole; and
(e) such counsel calls to your attention the provisions
of Sections 1717 and 1717.5 of the California Civil Code, which limit
and create obligations for the payment of attorney's fees.
Our opinions set forth in paragraph 4 are based upon our consideration
of only those statutes, rules and regulations which, in our experience, are
normally applicable to private placements of common equity securities. We
express no opinion in paragraph 4 as to the application of laws which by custom
are understood to be excluded from such opinions and identified in Section 19 of
the Legal Opinion Accord of the Section of Business Law of the American Bar
Association (1991). Without limiting the foregoing, we express no opinion in
paragraph 4 as to the application of Section 548 of the federal Bankruptcy Code
and comparable provisions of state law, federal securities laws (certain aspects
of which are addressed elsewhere herein), state securities laws, antifraud laws,
antitrust or trade regulation laws, the Hatch/Waxman Patent Term Extension Act
and the other patent laws of the United States or the rules and regulations of
the U.S. Patent and Trademark Office, the Federal Food, Drug and Cosmetic Act,
the Public Health Service Act, the Food and Drug Administration Modernization
Act, the Orphan Drug Act or the rules and regulations of the Federal Food and
Drug Administration, or any other federal or California laws pertaining to the
regulation of the development, testing, manufacture or sale of drugs.
2
EXHIBIT B
FORM OF GENERAL COUNSEL OPINION
1. To my knowledge, the issuance and sale of the Shares by the
Company pursuant to the Stock Purchase Agreement will not result in the breach
of or a default under (i) any order, writ or decree of any court or governmental
agency having jurisdiction over the Company or the Subsidiaries or over any of
their respective properties or operations or (ii) any of the agreements listed
on Annex I hereto.
2. To my knowledge, there are no legal or governmental
proceedings pending or threatened against the Company of a character required to
be disclosed in an Annual Report on Form 10-K or Quarterly Report on Form 10-Q
by the Securities Exchange Act of 1934, as amended, other than those described
in the SEC Documents, except for such proceedings as, if the subject of an
unfavorable decision, would not individually or in the aggregate result in a
material adverse change in the earnings, business, management, properties,
assets, operations, condition (financial or otherwise) or prospects of the
Company and its subsidiaries, taken as a whole, or prevent the consummation of
the transactions contemplated by the Purchase Agreement.
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EXHIBIT 1.23
WYETH PATENTS
CL 285,489
United States
U.S. 6,399,621 expires 8/9/2020
U.S. 4,900,836 expires 2/13/2007
U.S. 4,521,422 expires 6/23/2003
EXHIBIT 2.2
FORM OF ASSIGNMENT AND ASSUMPTION AGREEMENT
THIS ASSIGNMENT AND ASSUMPTION AGREEMENT (this "Assignment"), dated as of
__________ ___, 2004, is entered into by and between Wyeth Holdings Corporation
(formerly known as "American Cyanamid Company"), a Maine corporation, having a
place of business at 5 Giralda Farms, Madison, New Jersey 07940 (hereinafter
"Assignor"), Neurocrine Biosciences, Inc., a Delaware corporation, having a
place of business at 10555 Science Center Drive, San Diego, California 92121
(hereinafter, "Assignee"), and DOV Pharmaceutical, Inc., a New Jersey
corporation, having a place of business at 433 Hackensack Avenue, Hackensack,
New Jersey 07601 (hereinafter, "DOV"), and is executed and delivered pursuant to
that certain Assignment and License Agreement, dated as of February 26, 2004, by
and among Assignor and Assignee (the "Agreement") and that certain Consent
Agreement and Amendment, dated as of February 24, 2004, by and among Assignor,
Assignee and DOV (the "2004 Consent Agreement").
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto hereby agree as
follows:
1. Assignment. Assignor hereby absolutely and irrevocably grants,
bargains, assigns, transfers, sets over, conveys and delivers to Assignee, and
Assignee hereby accepts from Assignor, Assignor's right, title and interest in
and to (i) that certain License Agreement, dated as of __________________ ___,
2004, between DOV and Assignor (the "Compound License Agreement"), which
Compound License Agreement relates solely to the compound designated as CL
285,489 (also known as Indiplon) (the "Compound"), and (ii) that certain Consent
and Agreement dated December 13, 2002 by and among Assignor, Assignee and DOV
(the "2002 Consent Agreement") solely to the extent such right, title and
interest in and to the Consent Agreement relate to the Compound.
2. Assumption. Subject to the terms and conditions of the Agreement and
the 2004 Consent Agreement, Assignee hereby assumes all liabilities and
obligations of Assignor under (i) the Compound License Agreement and (ii) the
2002 Consent Agreement solely to the extent such liabilities and obligations
under the Consent Agreement relate to the Compound.
3. Further Assurances. Assignor agrees to furnish to Assignee all such
resolutions, certificates, other documents and access to information and to take
such other action as Assignee may from time to time reasonably request to
evidence, confirm and fully implement the assignment of contract rights and
assumption of liabilities made hereby.
4. Successors and Assigns. This Assignment shall be binding upon and shall
inure to the benefit of the parties hereto and their successors and assigns.
5. Counterparts. This Assignment may be executed in any number of
counterparts, each of which when so executed and delivered shall be deemed an
original and all of which taken together shall constitute but one and the same
instrument.
6. Amendments. No amendment, waiver, modification, termination or
cancellation of this Assignment shall be effective unless made in writing and
signed by the party against whom enforcement is sought.
7. Severability. Wherever possible, each provision of this Assignment
shall be interpreted in such a manner as to be effective and valid under
applicable law, but if any provision of this Assignment shall be prohibited by
or invalid under such law, such provision shall be ineffective to the extent of
such prohibition or invalidity, without invalidating the remainder of such
provision or the remaining provisions of this Assignment.
8. Terms of the Agreement. The terms of the Agreement are incorporated
herein by this reference. In the event of any conflict or inconsistency between
the terms of the Agreement and the terms hereof, the terms of the Agreement
shall govern.
9. Governing Law, Entire Agreement, etc. This Assignment shall for all
purposes be governed by the laws of the State of New York without regard to
choice of law or conflicts of law provisions. This Assignment constitutes the
entire understanding among the parties hereto with respect to the subject matter
hereof and supersedes any prior agreements, written or oral, with respect
thereto.
10. Definitions. Unless otherwise defined herein, capitalized terms shall
have the meanings given to such terms in the Agreement.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the parties have caused this Assignment to be executed
and delivered as of the date first above written.
ASSIGNOR:
WYETH HOLDINGS CORPORATION
By: _______________________
Name:
Title:
ASSIGNEE:
NEUROCRINE BIOSCIENCES, INC.
By: _______________________
Name:
Title:
DOV PHARMACEUTICAL, INC.
By: _______________________
Name:
Title:
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EXHIBIT 2.4
FORM OF PATENT ASSIGNMENT
This PATENT ASSIGNMENT (this "Assignment") dated as of March ___ 2004 (the
"Effective Date"), is made by and between WYETH HOLDINGS CORPORATION, a
corporation organized and existing under the laws of the State of Maine and
having a principal place of business at Five Giralda Farms, Madison, New Jersey
07928 ("Assignor") and NEUROCRINE BIOSCIENCES, INC., a corporation organized and
existing under the laws of the State of Delaware, United States of America and
having a place of business at 10555 Science Center Drive, San Diego, California
92121 United States of America ("Assignee"). Capitalized terms used herein but
not otherwise defined herein shall have the meanings set forth in the Assignment
and License Agreement (the "Assignment and License Agreement") dated as of the
date hereof by and between Assignor and Assignee.
In partial consideration for the purchase price set forth in the
Assignment and License Agreement, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, Assignor assigns and
transfers to the Assignee, and the Assignee's successors and assigns, and the
Assignee accepts, subject to the conditions of the Assignment and License
Agreement, such assignment and transfer, the entire right, title and interest in
and to the invention entitled:
N-METHYL-N-(3-{3-[2-THIENYLCARBONYL]-PYRAZOL-[1,5-(alpha)]-PYRIMIDIN-7-YL}
PHENYL)ACETAMIDE AND COMPOSITIONS AND METHODS RELATED THERETO
and which is found in:
U.S. application Serial No. 09/636,381 filed on August 9,
2000, now U.S. Patent No. 6,399,621, issued on June 4, 2002,
including any reissues or re-examinations thereof, and any patent term
extensions arising therefrom (the "Patent Rights"),
said Patent Rights to be held and enjoyed by the above-named Assignee, for
Assignee's own use and benefit, and for Assignee's successors and assigns to the
full end of the term or terms for which said patent(s) may be granted, subject
only to the conditions of the Assignment and License Agreement.
Interested parties who acquire title, rights or grants to the Patent
Rights are hereby notified that certain restrictions and obligations set forth
in the Assignment and License Agreement have been made appurtenant to and run
with the Patent Rights and such interested parties are on notice of such
restrictions and obligations.
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Wyeth Holdings Corporation
__________________________
[Name]
[Title]
ACKNOWLEDGMENT
State of _______________________ }
ss:
County of ______________________ }
On the day of 2005, personally appeared before me, known by me to be
the same person described in and who executed the foregoing instrument, and
acknowledged that he/she executed the same, of his/her own free will and for the
purposes set forth.
___________________________
Notary Public
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EXHIBIT 8.3
PRESS RELEASE
INTENTIONALLY OMITTED
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