CONFIDENTIAL TREATMENT REQUESTED
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AMENDMENT NUMBER 2 TO DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
This Amendment to Development, License, Supply Agreement (the
"Amendment") is effective as of the 1st day of December 1998 between Elan
Corporation plc, a corporation organized under the laws of Ireland ("Elan") and
Schein Pharmaceutical, Inc., a Delaware corporation ("Schein").
Introduction
A. Elan and Schein entered into a Development, License and Supply
Agreement, dated March 31, 1998, as amended by Amendment Number 1 to the
Development, License and Supply Agreement (the "Agreement").
B. The parties wish to amend the Agreement in accordance with the \
terms of this Amendment.
NOW, THEREFORE, in consideration of the mutual covenants and promises
herein contained, and for other good and valuable consideration, it is agreed as
follows:
1. Definitions and Incorporation. Unless otherwise defined, all terms
used herein shall have the meaning ascribed to them in the Agreement, and the
terms and provisions of the Agreement are incorporated herein by reference as
though set forth in full.
2. Amendments. The parties agree as follows with respect to the
pharmaceutical product __*__, each with an A Rated equivalence rating to __*___:
2.1. __*__ shall be included in the definition of "DSDF" (and
thereby also included in the definition of "Product") under the terms and
conditions of the Agreement provided however, that the exclusive license granted
to Schein for __*__ pursuant to Clause 2.1 of the Agreement shall be limited to
prescription use in the Territory. For the avoidance of doubt, Schein shall have
no rights to __*__ for over the counter non-prescription use in the Territory.
2.2. Schein shall pay to Elan a license fee with respect to
__*__ in the aggregate amount of $1,000,000, which shall be due upon the
execution of this Amendment by both parties but payable on 31st March 1999.
2.3. No development fees shall be payable to Elan for __*__ under
the Agreement, including, without limitation, the cost for Pivotal Bio PK Study,
pharmacokinetic studies and related assays, stability data generation, clinical
studies and compilation and submission of dossiers required for registration,
and market pack stability studies. Furthermore,
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* Material omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.
in no event, shall Elan shall be obliged to incur any such development fees or
perform any development work on __*__.
2.4. With respect to the __*__, the Parties hereby expressly agree
that (i) Clauses 3.2 and 10.3 of the Agreement shall not apply and have no force
or effect, and (ii) the application of Clause 13.1.1 of the Agreement shall be
subject to Clause 2.6 of this Addendum. Schein also acknowledges that Clause 4.3
of the Agreement does not in any way restrict Elan's freedom to license third
parties or itself to market any __*__ product which is A Rated to __*__ for over
the counter non-prescription use in the Territory.
2.5. At a date to be agreed in good faith between the Parties but
in no event before July 1, 1999 (the "Supply Date"), Elan shall supply __*__
exclusively to Schein for prescription use under the terms of the Agreement.
Elan shall use its commercially reasonable efforts to expeditiously supply __*__
to Schein prior to July 1, 1999. From and after said Supply Date, Elan shall be
entitled to receive 45% of the Profit of __*__ in accordance with Clause 10.5 of
the Agreement. For avoidance of doubt, the Parties hereby expressly agree that
Elan's obligation to supply __*__ to Schein under the Agreement shall have no
force or effect prior to the Supply Date and in particular, the provisions of
Clauses 9.15 and 12.5.3 shall have no effect prior to such Supply Date.
2.6. As of the date hereof, Elan is required to supply __*__ to
__*__ ("__*__") pursuant to an agreement, dated __*__, as amended (the "__*__
Agreement"). Elan hereby undertakes to terminate in full the __*__ Agreement
and __*__'s right to sell __*__ for prescription use in the Territory effective
__*__. Elan shall pay to Schein __*__ generated by __*__ and Elan under the
terms of the __*__ Agreement with respect to the sale of __*__ during the period
commencing __*__ and ending __*__. Such __*__ shall be due and payable by Elan
to Schein promptly after receipt thereof by Elan.
3. Reaffirmation of the Agreement and Other Documents. Except as
modified herein, all of the covenants, terms and conditions of the Agreement,
and all documents, instruments and agreements executed in conjunction therewith
remain in full force and effect and are hereby ratified and reaffirmed in all
respects. In the event of any conflict, inconsistency or incongruity between the
terms and conditions of this Amendment and the covenants, terms and conditions
of the Agreement or any documents, instruments or agreements executed in
conjunction therewith, the terms and conditions of this Amendment shall govern
and control.
4. Counterparts. This Amendment may be executed in two or more
counterparts, each of which together shall constitute an original but which,
when taken together, shall constitute but one instrument.
IN WITNESS WHEREOF, this Amendment is executed as of the day and year
first above written.
ELAN CORPORATION, PLC
By: /s/ Xxxxx X. Xxxxxx
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Name:
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Title:
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SCHEIN PHARMACEUTICAL, INC.
By: /s/ Xxxx Xxxxxxxxx
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Name: Xxxx Xxxxxxxxx
Title: Sr VP, Strategic Development
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* Material omitted pursuant to a request for confidential treatment. The omitted
material has been filed separately with the Securities and Exchange Commission.
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