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Supply Agreement > EX-10.10:
Re: Supply And Distribution Agreement: Investigational Phase between Omrix
biopharmaceuticals, Ltd. and FFF Enterprises, Inc., dated as of
December 21, 2005 (the "Agreement")
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Exhibit 10.10
(OMRIX BIOPHARMACEUTICALS(TM) LOGO)
innovative solutions
for a healthier world
August 10, 2006
Mr. Patrick Schmidt
FFF Enterprises, Inc.
41093 County Center Drive
Temecula, CA 92651
Re:
Supply And Distribution Agreement: Investigational Phase between
Omrix
biopharmaceuticals,
Ltd. and FFF Enterprises, Inc., dated as of
December 21, 2005 (the "Agreement")
Dear Pat:
To date, the FDA has not approved the Treatment Protocol and the
Treatment
Protocol Charge Price for Omrigam NF. Nevertheless, FFF and Omrix
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
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