1
EXHIBIT 4.4
FIRST AMENDMENT
OF
REGISTRATION AND DISTRIBUTION AGREEMENT
This Registration and Distribution Agreement (the "Agreement") entered
into as of August 31, 1995, by and between Therapeutic Antibodies Inc, a
Delaware corporation ("TAb") and X. X. Xxxxxxxx & Co. Limited, a South
Australian corporation ("FHF") is hereby amended in the following manner as of
March 14, 1996:
1. Schedule 1.1 shall be deleted in its entirety, and the attached
Schedule 1.1 shall be inserted in lieu thereof.
2. TAb and FHF have agreed to delete the Xxxxx Snake antivenin ("BSA")
from the Products which FHF will seek registration and marketing approvals for
and become exclusive dealer for in the Territory, according to the following
terms:
2.1 Invoice for Clinical Expenses. FHF agrees to prepare and submit
to TAb a written accounting and final invoice (the "Invoice") for all
documented, actual, and reasonable clinical expenses incurred by FHF to date
solely with respect to the clinical study for the BSA.
2.2 Transfer of Materials. All Materials (as defined below) shall be
promptly provided to TAb by FHF. "Materials" means documents provided by TAb to
FHF and other information pertaining to the clinical trial which is not
proprietary to FHF, as agreed between the parties. FHF acknowledges that the
Materials are the sole and exclusive property of TAb.
2.3 Consulting Services. FHF agrees to cooperate with TAb by
providing information on the preregistration work undertaken by FHF, and on the
preparatory work undertaken by FHF in connection with the proposed clinical
trial for BSA, so as to assist TAb to obtain distribution for the BSA in
Australia and Papua New Guinea. At TAb's request, FHF agrees to give reasonable
assistance to review, critique and monitor sales of the BSA.
2.4 Payments. In consideration for the prompt performance of
obligations hereunder, TAb shall pay FHF US$*******. Such payment, together with
all undisputed charges listed in the Invoice shall be due and payable within 30
days following receipt of all Materials. TAb shall also pay FHF a quarterly
deferred fee in the amount of *** percent of net revenue received by TAb from
the sale of BSA in Australia for the first ****** years after its marketing
approval.
2
2.5 Third Parties. Except as set forth on Exhibit A, FHF represents
and warrants that no third parties have performed services or obtained
BSA-related Confidential Information within the meaning of the Registration and
Distribution Agreement.
2.6 Survival. The rights and obligations set forth in Sections 12.7,
12.9, 12.10, 15, 17, 18, 19, and 23 of the Registration and Distribution
Agreement shall not terminate as of the effective date of this Amendment and
shall continue with respect to BSA. FHF shall have no right to use or register
any trademarks related to BSA.
3. Except and to the extent set forth herein, the parties reaffirm each
and every provision of the Agreement.
IN WITNESS WHEREOF, the parties hereto have executed this amendment of
the Agreement effective as of the date set forth above.
Therapeutic Antibodies Inc X. X. Xxxxxxxx & Co. Limited
By: /s/ Xxxxxx X. Xxxxx By: /s/ [Illegible]
-------------------------- -------------------------
Title: Chairman Name: [Illegible]
----------------------- -----------------------
Date: March 15, 1996 Title: [Illegible]
------------------------ ----------------------
---------------
* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.4.
2
3
SCHEDULE 1.1
THE PRODUCTS
a. Digitalis Overdose Antidote ("DigiTab")
b. Tricyclic Anti-depressant Antidote ("TriTAb")
c. Sri Lankan Anti-venin ("PulchellaTAb")
4
EXHIBIT A
***************************
Dr. **********************************, Northern Territory
Dr. **********************************, Western Australia
Dr. *************************************************, New South Wales
Dr. **************************************, Parkville, Victoria
Professor *************************************, Xxxxxxxx, Xxxxxxxxxx
Dr. *********************************, Camperdown, New South Wales
Dr. *****************************************, Adelaide, South Australia
---------------
* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.4.
