EXHIBIT 2.1 ASSIGNMENT AND LICENSE AGREEMENTIP Intellectual Property License Assignment Agreement |
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EXHIBIT 2.1
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
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TABLE OF CONTENTS
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PAGE
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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
</TABLE>
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<TABLE>
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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
</TABLE>
Exhibit 1.7 Form of Compound License Agreement
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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
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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
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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
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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
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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.
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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).
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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
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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
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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
Wye
