Development Agreement [Amendment No. 1] - Medisorb Technologies International LP and Janssen Pharmaceutica International
FIRST AMENDMENT TO DEVELOPMENT AGREEMENT
This First Amendment to that certain Development Agreement, dated 23 December
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1993 (hereinafter "the Development Agreement"), by and between MEDISORB
TECHNOLOGIES INTERNATIONAL L.P. ("Medisorb"), a Delaware limited partnership,
doing business at 6954 Cornell Road, Cincinnati, Ohio 45242, and JANSSEN
PHARMACEUTICA INTERNATIONAL, a division of Cilag International AG, ("Janssen"),
a Swiss business corporation, doing business at Kollerstrasse 38, CH-6300 Zug 6,
Switzerland, is agreed this 6th day of December, 1995.
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WHEREAS, the Parties desire to amend certain terms of the Development Agreement
respecting the timing of Janssen's right to exercise its option to license MTI
technology and, further, respecting, certain milestone dates;
NOW THEREFORE, the parties agree to amend the Development Agreement as follows:
(A) Section 4(A) of the Development Agreement is hereby amended in its entirety
to read as follows:
The initial term of this Agreement shall commence upon the date first above
written and continue thereafter until the earlier of (i) the completion of
the Development Program at the moment of finalization of the IRF, which is
expected during the [ ], or (ii) [
], unless earlier terminated pursuant to the provisions of this Section 4
or according to the terms of Section 16 below. However, in the event that
the IRF has not been completed by [ ], if Janssen can
show due diligence, this Agreement shall not terminate and will be extended
for such period as Janssen requires to finalize the IRF, provided that
during such extension Janssen continues to show due diligence. Due
diligence, amongst other factors, shall mean the timely filing of required
regulatory applications, including, without limitation, a CTX (clinical
trial exemption certificate) and/or IND, and continuing to fund the
Development Program in a commercially reasonable manner.
(B) Section 6(A) of the Development Agreement is hereby amended in its entirety
to read as follows:
Medisorb hereby grants to Janssen an option, exercisable at any time during
the term of this Agreement and continuing for a period of thirty (30) days
thereafter to enter into the License Agreements (i.e., the first a
worldwide license, excluding the United States, and the second a license
encompassing only the United States) attached hereto as Exhibits B & C,
respectively.
All capitalized terms used in this First Amendment shall have the same meanings
as defined in the Development Agreement. Other than the foregoing, all other
terms of the Development Agreement remain in full force and effect.
WITNESS the signature of both parties by their duly authorized officers:
JANSSEN PHARMACEUTICA INTERNATIONAL
A division of Cilag International AG
By: /s/ Erik Rombouts
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Name: Erik Rombouts
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Title: Operations Director
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Date: 12/12/95
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIALS IS BRACKETED AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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DEVELOPMENT AGREEMENT
AMENDMENT
JANSSEN-MEDISORB
[Second Janssen Signatory]
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By: /s/ Heinz Schmid
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Name: Heinz Schmid
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Title: General Manager
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Date: 12/12/95
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MEDISORB TECHNOLOGIES INTERNATIONAL L.P.
by: Medisorb Technologies
International, Inc.,
its General Partner
By: /s/ David R. Lohr
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Name: David R. Lohr
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Title: President
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Date: December 6, 1995
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.