Exhibit 10.69
CONFIDENTIAL TREATMENT REQUESTED
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THIS AMENDMENT, dated February 28, 2000 (this "Amendment"), to the MULTI PRODUCT
TECHNOLOGY TRANSFER DEVELOPMENT AND LICENSE AGREEMENT, by and between SCHEIN
PHARMACEUTICAL, INC., a Delaware corporation, having its principal place of
business at 000 Xxxxxx Xxxxx, Xxxxxxx Xxxx, Xxx Xxxxxx 00000 X.X.X. ("Schein")
and AMARIN CORPORATION PLC (formerly known as ETHICAL HOLDINGS PLC) having its
principal place of business at Xxxxxx Xxxxx, Xxxxxxxxxxx'x Xxxx, Xxx, Xxxxx XX0
0XX, Xxxxxx Xxxxxxx ("Amarin").
R E C I T A L S:
X. Xxxxxx and Amarin are parties to that certain Multi Product Technology
Transfer Development and License Agreement, dated August 30, 1994, as amended
(the "Agreement"). Capitalized terms used herein which are not otherwise defined
shall have the meanings ascribed to them in the Agreement.
B. Pursuant to Section 4 and Schedule 3 of the Agreement, Schein is obligated to
select twelve (12) Designated Products from the Prospective Development Products
and the parties are obligated to immediately commence work on the Designated
Development Programme for such Designated Products.
C. Pursuant to the Agreement, Schein has designated Designated Products from the
Prospective Development Products and the parties have commenced work on the
Designated Development Programme for such Designated Products.
X. Xxxxxx and Amarin acknowledge that several of the Designated Development
Programmes for several of the Designated Products have been unsuccessful or that
Amarin will, following *.
E. The parties wish to amend the Agreement to provide, among other things (i)
for the deletion of those Designated Products which the parties have
previously determined are not suitable for development or that Amarin will no
longer possess the rights for such development (ii) to confirm their
intention to continue with the existing Designated Development Programmes for
* and *; and (iii) to provide for the future designation of additional
Designated Products, in accordance with the terms and conditions set forth
herein.
NOW, THEREFORE, the parties agree as follows:
1. DELETION OF DESIGNATED PRODUCTS AND PROSPECTIVE DEVELOPMENT PRODUCTS. The
following products are hereby deleted from the Schedule 5 listing and other
designations of Prospective Development Products and shall no longer be deemed
to be Designated Products:
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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.
*
*
*
*
*
*
2. CONFIRMATION OF DESIGNATED DEVELOPMENT PROGRAMMES FOR * AND *. The parties
confirm their intention to continue with the Designated Development
Programmes for * and * in accordance with the Agreement; Amarin confirms, in
connection with such Designated Development Programmes, to be responsible for
payment of the cost of the pilot bio-studies only for such * and * products
manufactured by or on behalf of Schein to be carried out in accordance with
the appropriate regulatory guidelines in the relevant Territory as are in
force at the time of this Amendment.
3. DESIGNATION OF ADDITIONAL DESIGNATED PRODUCTS. Notwithstanding anything
contained in the Agreement to the contrary, the parties acknowledge and agree
that Schein's obligation to designate additional Designated Products shall be
limited to * products and that Schein shall designate and Amarin shall
mutually agree to such products to be Designated Products within one hundred
and eighty (180) days of the date of this Amendment. Amarin will expend a
maximum of * on Pilot Biostudies per additional Designated Product; and that
until such time Schein retains all rights under Section 5.4 of the Agreement
to apply the balance of the Notional Sums to any alternative Designated
Development Programme with respect to any additional Designated Products
designated by Schein.
4. REAFFIRMATION OF SUPPLY 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.
5. 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
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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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constitute but one instrument and shall become effective when copies hereof,
when taken together, bear the signatures of all required parties and persons.
IN WITNESS WHEREOF, this Amendment is executed as of the day and year first
above written.
AMARIN CORPORATION PLC
By: /s/ Xxxxxxx X.X. Xxxxxxx
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Name: Xxxxxxx X.X. Xxxxxxx
Title: President & CEO
SCHEIN PHARMACEUTICAL, INC.
By: /s/ Xxxx Xxxxxxxxx
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Name: Xxxx Xxxxxxxxx
Title: Senior Vice President, Strategic
Development
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