EXHIBIT 4
CONFIDENTIAL TREATMENT REQUESTED
Dated 20 August, 0000
XXXX XXXXXXXXXXX, plc
AND
LIGAND PHARMACEUTICALS INCORPORATED
AMENDMENT TO DEVELOPMENT, LICENCE AND SUPPLY AGREEMENT
THIS AMENDMENT AGREEMENT is made on 20 August, 1999.
BETWEEN:
(1) ELAN CORPORATION, PLC, a company incorporated in Ireland having its
registered office at Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx
("ELAN") and
(2) LIGAND PHARMACEUTICALS INCORPORATED, a company organized under the laws of
Delaware, with offices at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx
00000, Xxxxxx Xxxxxx of America ("LIGAND").
RECITALS:
A. ELAN and LIGAND entered into a Development, License and Supply Agreement
dated 9 November, 1998 ("the Agreement").
B. The clinical costs associated with the Agreement have transpired to be
greater than ELAN and LIGAND originally envisaged and accordingly, ELAN and
LIGAND wish to enter into this Amendment Agreement to adjust the license
royalties payable to ELAN under Clause 10.1 of the Agreement, and also the
commitment by LIGAND under Clause 5.5 of the Agreement to undertake
additional clinical expenditure, including Phase III and Phase IV clinical
trials, related to the commercialization of the PRODUCT in the TERRITORY,
to the extent set forth in Clause 1 hereof.
All capitalized terms used in this Amendment Agreement shall have the same
meanings as are assigned thereto in the Agreement, except where expressly
provided to the contrary in this Amendment Agreement.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1 Amendment to the Agreement:
ELAN and LIGAND hereby agree that the Agreement shall be amended as
follows:
1.1 by the deletion of Clause 10.1 of the Agreement and the substitution
therefor of the following:
"10.1 Licence Royalties:
10.1.1 In consideration of the licence of the ELAN PATENTS granted to
LIGAND under this Agreement, LIGAND shall pay to ELAN the following
amounts:-
(1) $5 million in cash or in shares of Common Stock of LIGAND, par
value $.001 per share (the "Common Stock") (valued at $11.65 per
share), at LIGAND's option, upon the execution of the Agreement
by both parties;
(2) $10 million in cash, or at LIGAND's option, in cash through an
increase in the issue amount of the CONVERTIBLE NOTE, upon the
execution of the Agreement by both parties;
(3) $5 million in cash or in shares of Common Stock of LIGAND (valued
at a price per share equal to the average of the CLOSING PRICE of
the Common Stock for the 5 consecutive trading days immediately
prior to the required payment date thereof), at LIGAND's option,
upon substantial completion of full original patient enrolment in
the Phase III pivotal efficacy studies relating to the submission
of the NDA for the PRODUCT in the U.S.A. if, and only if,
accomplished on or prior to 31 December 1999.
(4) up to a maximum of $5 million in cash or in shares of Common
Stock of LIGAND (valued at a price per share equal to the average
of the CLOSING PRICE of the Common Stock for the 5 consecutive
trading days immediately prior to the required payment date
thereof), at LIGAND's option, upon submission of the NDA for the
PRODUCT in the U.S.A. provided that the exact amount of this
payment will be determined (and become payable) in accordance
with the date upon which the NDA for the PRODUCT is submitted in
the USA, as specified below:
********** upon submission of the NDA for the PRODUCT in the
U.S.A. on or prior to **********;
********** upon submission of the NDA for the PRODUCT in the
U.S.A. after ********** but on or prior to **********;
********** upon submission of the NDA for the PRODUCT in the
U.S.A. after ********** but on or prior to **********;
********** upon submission of the NDA for the PRODUCT in the
U.S.A. after ********** but on or prior to **********;
********** upon submission of the NDA for the PRODUCT in the
U.S.A. after ********** but on or prior to **********;
********** upon submission of the NDA for the PRODUCT in the
U.S.A. on any date after **********.
(5) $5 million in cash or in shares of Common Stock of LIGAND (valued
at a price per share equal to the average of the CLOSING PRICE of
the Common Stock for the 5 consecutive trading days immediately
prior to the required payment date thereof), at LIGAND's option,
upon the NDA APPROVAL of the PRODUCT in the U.S.A.
10.1.2 In the event that LIGAND elects to issue shares of the Common Stock
pursuant to Clause 10.1.1(1), (3), (4) or (5) or the CONVERTIBLE NOTE
pursuant to Clause 10.1.1(2), each such issuance shall be made pursuant to,
and subject to the terms and conditions set forth in, the PURCHASE
AGREEMENT. Nothing in this Agreement shall relieve LIGAND from its
obligations to make the payments set forth in Clauses 10.1.1(1), (2), (3),
(4) or (5), in cash, in the event that any of the applicable conditions set
forth in the PURCHASE AGREEMENT are not satisfied or waived on or prior to
the required payment date thereof; provided however, that in the event that
LIGAND elects to issues shares of Common Stock pursuant to Clause
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10.1.1.(1), (3), (4) or (5) and ELAN is unable to satisfy the conditions to
such issuance as set forth in the PURCHASE AGREEMENT or if such conditions
have not been waived by LIGAND, as the case may be, LIGAND and ELAN shall
negotiate in good faith to agree upon customary terms and conditions which
will enable LIGAND to issue such shares pursuant to a transaction exempt
from the registration requirements of the Securities Act pursuant to
Regulation D thereunder, including the giving by ELAN, to the extent
possible, of representations and warrranties in connection therewith."
1.2 by the deletion of Clause 5.5 of the Agreement and the substitution
therefor of the following:
"5.5 For the ********** following submission of the NDA in the USA, LIGAND shall
commit to undertake additional clinical expenditure, including **********
(including FULLY ALLOCATED COST of LIGAND and the sums paid by LIGAND to
ELAN as referred to in Clause 5.4 above). The objective of the programme so
conducted shall be to ********** . LIGAND agrees to carry out and complete
the clinical efficacy programme to a standard and timeframe that LIGAND
would otherwise find acceptable for one of its major branded products.
LIGAND shall keep ELAN informed as to the ********** LIGAND undertakes that
it shall carry out all such clinical studies to prevailing cGCP and cGLP
and most specifically in accordance with FDA standards and guidelines. In
the event that LIGAND does not expend ********** during the **********
following submission of the NDA in the USA, then, unless otherwise agreed
in writing between the parties, LIGAND shall pay any shortfall between
the********** and the actual sum expended by LIGAND to ELAN, provided
however, in the event the FDA notifies ELAN of its refusal to grant the NDA
submitted by ELAN and LIGAND, after discussion with ELAN, determines that
it is not commercially viable for LIGAND to incur any additional
development expenses as provided in Clause 5.4, LIGAND shall have no
further obligation to expend or remit sums under this Clause 5.5. In such
event, ELAN shall have the right to terminate this Agreement. Thereafter,
ELAN shall be entitled to research, develop and commercialise the PRODUCT
in the TERRITORY. In the event of such termination, all monies paid to ELAN
by LIGAND pursuant to this Agreement shall not be recoverable by LIGAND."
2 Governing law and jurisdiction:
This Amendment Agreement is construed under and ruled by the laws of New
York. For the purposes of this Amendment Agreement the parties submit to
the non-exclusive jurisdiction of the courts of New York.
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IN WITNESS of which the parties have executed this Amendment Agreement.
Executed by LIGAND on 20 August, 1999
By : /s/ Xxxxx X. Xxxxxxxx
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Name: Xxxxx X. Xxxxxxxx
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Title: President and Chief Executive Officer
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Executed by ELAN on 20 August, 1999
By: /s/ Xxxxxx Xxxxxxxx
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Name: Xxxxxx Xxxxxxxx
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Title: Executive Vice President - Corporate Development
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