Exhibit 10.10
(OMRIX BIOPHARMACEUTICALS(TM) LOGO)
innovative solutions
for a healthier world
August 10, 2006
Mr. Xxxxxxx Xxxxxxx
FFF Enterprises, Inc.
00000 Xxxxxx Xxxxxx Xxxxx
Xxxxxxxx, XX 00000
Re: Supply And Distribution Agreement: Investigational Phase between Omrix
biopharmaceuticals, Ltd. and FFF Enterprises, Inc., dated as of
December 21, 2005 (the "Agreement")
Dear Xxx:
To date, the FDA has not approved the Treatment Protocol and the Treatment
Protocol Charge Price for Omrigam NF. Nevertheless, FFF and Xxxxx have agreed to
conduct the Phase 3 Clinical Trial in accordance with Section 4.2.c.2 of the
Agreement, as modified by the following terms:
1. FFF commits to complete the Phase 3 Clinical Trial independent of
receiving an approval for the Treatment Protocol and Treatment
Protocol Charge Price.
2. FFF will continue to attempt to obtain approval from the FDA for
Treatment Protocol and Treatment Protocol Charge Price during the
Phase 3 Clinical Trial.
3. Omrix commits to supply FFF with Omrigam NF manufactured from source
plasma in the amount required for the Phase 3 Clinical Trial.
4. Omrix will invoice and FFF will pay the Treatment Protocol Purchase
Price (*** per gram) for the Omrigam NF supplied for the purpose of
the Phase 3 Clinical Trial. FFF will pay this amount notwithstanding
the provisions of Section 4.3.a of the Agreement. Payment will be due
within 30 days from the date of shipping. The cost of purchasing
Omrigam NF under this letter shall not be included in the calculation
of FFF's out-of-pocket expenses for conducting the Clinical Trials
under Section 15.3.a of the Agreement.
5. If FFF receives approval of a Treatment Protocol from the FDA, Omrix
will credit FFF for the Treatment Protocol Purchase Price charged by
Omrix for Omrigam NF supplied by Omrix for the Phase 3 Clinical Trial
prior to the receipt of a Treatment Protocol (the "Credit Amount").
The credit will be applied against purchases of Omrigam NF made under
the Treatment Protocol up to the Credit Amount.
OMRIX biopharmaceuticals Ltd.
PORTIONS OF THIS EXHIBIT MARKED BY AN *** HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(OMRIX BIOPHARMACEUTICALS(TM) LOGO)
innovative solutions
for a healthier world
6. The parties agree that approval of a Treatment Protocol shall no
longer be a basis for termination of the Agreement. Accordingly,
Section 15.2.b to the Agreement is amended to delete "If the Treatment
Protocol is not approved within two (2) months from when the Treatment
Protocol was received by the FDA; or" to read in its entirety: "If the
Treatment Protocol is approved by the FDA and (i) approval is
subsequently revoked or (ii) the Treatment Protocol is placed on
clinical hold and the Treatment Protocol cannot be reinstated without
undue hardship to either Party;".
7. The parties agree that the Treatment Protocol will only apply to
primary immune deficiency. Accordingly, in the 1st sentence of the
definition of Treatment Protocol, in Section 1.26 of the Agreement,
the following words are deleted: "and other immune diseases" and the
4th sentence in Section 2.10 of the Agreement shall be revised to
read: "In the event the FDA approves the use of the Investigational
Drug in the Treatment Protocol for primary immune deficiency, the
first payment will commence..."
8. As applicable to clause (iii) of Section 15.3d of the Agreement, the
applicable date shall be changed from September 1, 2007 to 12 months
from approval of the Treatment Protocol.
9. Clause (b) of Section 15.3(e) of the Agreement shall be changed from
"up to a maximum amount of *** for the Investigational Drug
supplied by Omrix for the Clinical Trials at the Treatment Protocol
Purchase Price" to the amount of the Credit Amount applied against
purchases of Omrigam NF made by FFF under the Treatment Protocol.
This letter is issued under the Agreement, and except as modified herein, the
Agreement continues in full force. All terms capitalized in this letter, not
otherwise defined herein, shall have the meaning set forth in the Agreement.
Please sign below, and return copy to Omrix, to indicate FFF's agreement to the
terms of this letter.
Very truly yours,
/s/ Xxxxxx Xxxx
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Xxxxxx Xxxx
FFF Enterprises, Inc.
By: /s/ Xxx Xxxxxxx
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Name:
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Title:
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Date:
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OMRIX biopharmaceuticals Ltd.
