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SECOND ADDENDUM
Magainin Pharmaceuticals ("Magainin") and ▇▇▇▇▇▇ Laboratories
("Abbott") entered into a Purchase Order Agreement for Phase IV dated October 6,
1995 (the "Purchase Order") wherein Abbott is to perform certain activities
relating to Magainin's Bulk Product, as defined in the Purchase Order.
The Purchase Order was amended on May 8, 1996.
Magainin and Abbott desire to further amend the Purchase Order as
follows:
1. Abbott shall produce three (3) additional 1-kilogram batches
of bulk MSI-78. As previously discussed, the pricing and
payment schedule for each individual 1-kilogram batch will be
as follows:
QUALIFICATION RUNS PRICE PAYMENT
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First 1-Kilogram Batch $[***********] April-July 1997*
Second 1-Kilogram Batch $[***********] Upon Delivery of
the Second 4.5
Kilogram
Qualification Run
Third 1-Kilogram Batch $[***********] Upon Delivery of
the Third 4.5
Kilogram
Qualification Run
TOTAL $[***********]
*$[***********] per month
2. Abbott shall provide additional analytical services as described in
Attachment A to this Second Addendum. Magainin shall pay Abbott
$[*******] per month, beginning October 1996 and will continue to be
billed at the $[*******]/month rate through the end of May 1997. See
Attachment A for the activities executed in the Additional Analytical
Services Program.
3. All payments hereunder shall be made by the last day of each calendar
month.
4. Abbott shall make the following qualification runs in lieu of the
qualification runs set forth in the Purchase Order; three (3) one (1)
kilogram qualification runs and three
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(3) qualification runs manufactured at a 4.5 kilogram scale, to be
delivered on dates mutually agreed to by Magainin and Abbott.
5. Upon completion of the third 4.5 kilogram qualification run, a final
scale-up qualification run will be executed. This run is projected to
be produced at a 9 to 13.5 kilogram scale. The final decision
regarding the size of this run will be based on a mutual agreement
between Magainin and Abbott after review of the data available from
previous runs. Pricing for this final scale-up qualification run will
be $[***] per gram.
6. Abbott shall use its reasonable best efforts to ensure that the Drug
Master File for Bulk Drug Substance will be ready for submission to
the FDA (some of which qualification runs shall have less than six (6)
months stability data, in the fourth (4) quarter of 1997.
7. All other provisions of the Purchase Order, as amended, are hereby
ratified and confirmed.
IN WITNESS WHEREOF, the parties have executed this Second Addendum by
their duly authorized representatives as of the later date set forth below.
MAGAININ PHARMACEUTICALS INC. ▇▇▇▇▇▇ LABORATORIES
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
---------------------------- -----------------------------
Title: Executive Vice President and Title: Vice President of
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Chief Financial Officer Commercial Operations
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Date: May 7, 1997 Date: May 12, 1997
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ATTACHMENT A
ADDITIONAL ANALYTICAL ACTIVITIES PROGRAM
PURPOSE: To develop and execute a program, which will characterize impurities
relative to MSI-78. This program has evolved out of the August 1996 request by
the FDA that displays "a reasonable best effort" towards impurity
identification.
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IV.
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VI.
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VII.
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