<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
AMENDMENT NO. 1
(Mark One)
/X/ Quarterly Report pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the quarterly period ended March 31, 1996, or
/ / Transition Report pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
For the transition period from _____________ to _______________.
COMMISSION FILE NO.: 0-25978
THERAPEUTIC ANTIBODIES INC.
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE 62-1212485
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
1500 21ST AVENUE SOUTH, SUITE 310
NASHVILLE, TENNESSEE 37212
(Address of Principal Executive Offices) (Zip Code)
(615) 327-1027
(Registrant's Telephone Number,
Including Area Code)
NOT APPLICABLE
(Former Name, Former Address and Former Fiscal Year,
if Changed Since Last Report)
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
YES _X_ NO___
As of October 14, 1996, 21,428,795 shares of the registrant's Common
Stock were outstanding.
<PAGE> 2
PART II
OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
Exhibit
Number Description of Exhibits
- ------- -----------------------
4.1 -- Lease Assignment of 14/15 Newbury Street Lease dated February
1, 1996, between Immunogen International Limited and TAb
London Limited
4.2 -- Amendment, dated February 13, 1996, to Agreement dated
January 1, 1990, between Swedish Orphan AB and Therapeutic
Antibodies Inc.
4.3 -- Heads of Agreement, dated March 25, 1996, between Therapeutic
Antibodies Inc. and CSL Limited
4.4 -- First Amendment, dated March 14, 1996, of Registration and
Distribution Agreement, dated August 31, 1995, between F.H.
Faulding & Co. Limited and Therapeutic Antibodies Inc.
11.1 -- Statement re: computation of per share earnings
(b) Reports on Form 8-K.
The Company has not filed any Current Reports on Form 8-K during the
first quarter of 1996.
2
<PAGE> 3
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be filed on its behalf by the
undersigned thereunto duly authorized.
THERAPEUTIC ANTIBODIES INC.
Date: October 16, 1996 /s/ Martin S. Brown
-------------------
Martin S. Brown
Chairman of the Board
Chief Executive Officer
(Principal Executive Officer)
Date: October 16, 1996 /s/ Robert D. Brown
-------------------
Robert D. Brown
Vice President Accounting
Controller
(Principal Accounting Officer)
3
<PAGE> 4
EXHIBIT INDEX
Exhibit
Number Description of Exhibits
- ------- -----------------------
4.1 -- Lease Assignment of 14/15 Newbury Street Lease dated February
1, 1996, between Immunogen International Limited and TAb
London Limited (incorporated by reference to Exhibit 4.1 to
the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 1996, filed with the Securities and
Exchange Commission on May 6, 1996, Commission File
No. 0-25978)
4.2 -- Amendment, dated February 13, 1996, to Agreement dated
January 1, 1990, between Swedish Orphan AB and Therapeutic
Antibodies Inc.
4.3 -- Heads of Agreement, dated March 25, 1996, between Therapeutic
Antibodies Inc. and CSL Limited. The Registrant has requested
confidential treatment from the Securities and Exchange
Commission for portions of this Agreement.
4.4 -- First Amendment, dated March 14, 1996, of Registration and
Distribution Agreement, dated August 31, 1995, between F.H.
Faulding & Co. Limited and Therapeutic Antibodies Inc. The
Registrant has requested confidential treatment from the
Securities and Exchange Commission for portions of this
Agreement.
11.1 -- Statement re: computation of per share earnings (incorporated
by reference to Exhibit 11.1 to the Company's Quarterly
Report on Form 10-Q for the quarter ended March 31, 1996,
filed with the Securities and Exchange Commission on May 6,
1996, Commission File No. 0-25978)
<PAGE> 1
EXHIBIT 4.2
February 13, 1996
Swedish Orphan AB
Stureplan 15, 4tr.
111 45 Stockholm
Sweden
Gentlemen:
We refer to the Agreement made as of January 1, 1990, between Therapeutic
Antibodies Inc ("TAb") and Swedish Orphan AB ("Agent") which concerns the
product Vipera berus Antivenom (the "V. berus Agreement") as amended by a letter
dated December 31, 1992, and a separate letter dated March 1, 1994. TAb hereby
proposes the following amendments to the V.berus Agreement to be effective
January 1, 1996.
1. The following products shall be added to Appendix A (PRODUCTS):
- Tricyclic antidepressant Antidote, Therapeutic
Antibodies Inc ("TriTAb(TM)")
- Certain exotic snake antivenoms as identified by TAb.
Also, add ("ViperaTAb(TM)") after "Vipera berus antivenom,
Therapeutic Antibodies Inc"
2. Paragraph 2.3 shall be deleted and replaced with the following two
paragraphs:
2.3 Regulatory Affairs: Agent will be responsible for obtaining
and maintaining registration or other free-sale permits of
Products in the Territory. Registration shall include a full
product license for each Product (except for exotic
antivenoms) in at least one country within the Territory as
well as named patient basis approvals in every country in the
Territory (except for DigiTAb). Such activities shall be
carried out at expense of the Agent, except application fees,
annual registration dues including PDR Texts or out-of-pocket
costs of preparing submissions shall be borne by TAb. Agent
will handle any required translations from English to local
languages of package inserts
<PAGE> 2
and any other required written materials except that costs of
materials and labeling product packages shall be borne by TAb.
2.4 Clinical Trials: Agent will facilitate and assist with
clinical trials that are conducted with any of the Products in
any country within the Territory according to the Clinical
Trials Agreement which is attached to this letter as a new
Appendix D.
3. The phase "after due authorization by such third party customers"
shall be deleted from the second sentence of paragraph 3.0. The
third and final sentence of paragraph 3.0 shall be deleted in its
entirety, and the following sentences shall be inserted in lieu
thereof:
TAb shall submit an invoice to Agent for each order by Agent,
and payment shall be due in U. S. dollars within 60 days after
TAb sends such invoice for goods destined for final sale in
Sweden and 45 days for goods shipped elsewhere. The Agent
shall negotiate end user pricing with the Regulatory
Authorities in the Territory subject to final approval by TAb.
Agent will notify TAb immediately of any changes to prices in
the territory. TAb shall invoice in local currency for each
shipment at the end user Price in force in the Country with
deduction for agreed wholesaler discounts and 20% of the price
after deduction of wholesaler discounts. If Agent shall fail
to pay for any Products shipped hereunder, TAb may, without
limiting available remedies, defer further deliveries until
the overdue amounts are paid and until TAb is satisfied that
payment will be made for further deliveries.
4. The first sentence of paragraph 5.1 shall be deleted and the
following sentence inserted in lieu thereof:
"This Agreement shall become effective as of January 1, 1990 and
unless sooner terminated as provided herein shall remain in force
for an initial term which shall end on *****************."
5. In the first sentence of paragraph 4.0 after "On all orders
shipped", the phrase "by TAb to" shall be deleted and the phrase "by
TAb directly to third-party customers in" shall be added.
6. Appendix C Minimum Sales shall be deleted and shall be replaced with
the attached new Appendix C.
2
<PAGE> 3
Please signify your agreement with the above amendments by signing both
copies of this letter and returning one copy to TAb.
Therapeutic Antibodies Inc
By: /S/ Martin S. Brown
----------------------------
Martin S. Brown, Chairman
Date: 2/14/96
-------------------------
Accepted and Agreed:
Swedish Orphan AB
By: /s/ Lars-Uno Larsson
-------------------------------
Lars-Uno Larsson, President
Date: 1/3/96
------------------------------
- ---------------
* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.2.
3
<PAGE> 4
APPENDIX C
MINIMUM SALES: (Scandinavia) in Vials
Product 1996 1997 1998
------- ---- ---- ----
ViperTAb(TM) *** *** ***
DigiTAb(TM) to be agreed
TriTAb(TM) to be agreed
- ---------------
* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.2.
<PAGE> 5
APPENDIX D
AGREEMENT FOR CLINICAL SERVICES
This Agreement is effective 13th day of February 1996 between Swedish Orphan
(Agent) and Therapeutic Antibodies Inc (TAb).
TAb has requested that Agent provide assistance in the clinical studies (the
"Studies" or "Study") of TAb's Products in the Territory. Agent has agreed to
provide such assistance with the studies on the terms and conditions set forth.
In consideration of the mutual promises expressed, the parties agree as follows:
I. STUDY CONDUCT
Since TAb wishes to utilize the data obtained from these studies for
various worldwide registrations including the United States, it is imperative
that the Studies be conducted under U. S. government regulations, designed to
insure the acceptability of clinical data (i.e. Good Clinical Practices or
GCPs). It is understood that Agent will help assure that the following specific
elements of GCPs are in force throughout the conduct of the Studies:
a. Studies will be conducted according to a signed clinical protocol to
be provided by TAb and developed by TAb at its cost.
b. All individuals who conduct clinical trials (Investigators) will be
qualified under applicable law or regulations to conduct the Study.
c. A duly constituted Institutional Review Board (IRB) or equivalent
(e.g. Ethics Committee) shall be asked to review and approve the
protocol, protocol amendments, informed consent, and advertisements
for patients at each Study site.
d. All patients will sign an IRB approved, written informed consent
prior to enrolling in the Study.
e. TAb will provide all Study medication in labeled vials free of
charge. All Product for Study will be shipped to Agent for
distribution to the various
<PAGE> 6
Study sites. Detailed logs of all the shipments of Product will be
maintained by Agent.
f. Data will be collected on Case Report Forms (CRF's) provided by TAb
and developed at its cost. CRF's and other written material will be
shipped to Agent for distribution to the various Study sites. Logs
should also be maintained for these shipments. Completed CRF's will
be promptly returned to TAb based on forwarding instructions
provided by TAb.
g. TAb will be responsible for the selection of the independent
monitors to audit the various clinical sites and monitoring expenses
shall be borne by TAb. Auditing the centers will include the
verification of clinical data and adherence to the Study protocol.
Agent will be available to these independent monitors as a resource
for answering questions and solving problems.
h. TAb will negotiate all study budgets and contracts with the various
Study centers. Agent will help facilitate these negotiations.
i. Agent will make its clinical and regulatory personnel available to
implement these Studies at Agent's expense. Travel expenses outside
Sweden will be borne by TAb.
j. All TAb and Agent conduct will conform to all applicable laws and
regulations.
k. TAb shall have the right to immediately terminate a Study if issues
covering safety of Product arises. TAb may also terminate a Study
for any reason with three month's written notice.
II. OWNERSHIP OF DATA AND PUBLICATION
a. TAb is the sole owner of all data, and information associated with
the Product including any new invention that might arise from the
Studies.
b. All materials and information generated through the Study shall be
Confidential. Information according to the terms of the
Confidentiality Agreement between TAb and Agent.
c. Any information containing data from the Study will be provided to
TAb for its approval before publication.
<PAGE> 7
III. INDEMNITY & PRODUCT LIABILITY
a. TAb agrees to indemnify, hold harmless and defend Agent against all
claims resulting from the Study.
b. Agent agrees to indemnify and hold harmless, and defend TAb from all
claims resulting from negligence or willful misconduct of Agent.
c. TAb will obtain Product Liability Insurance to cover each study in
the Territory.
IV. CONSIDERATION
TAb and Agent enter into this Agreement for good and sufficient
consideration the receipt of which is hereby acknowledged.
V. COVENANTS
This Agreement shall be governed and construed in accordance with the
laws of the State of Tennessee.
Accepted and Agreed:
THERAPEUTIC ANTIBODIES INC SWEDISH ORPHAN AB
By /s/ Martin S. Brown /s/ Lars-Uno Larsson
--------------------------- -------------------------------
Title Chairman Title President
------------------ ------------------
Date 2/14/96 Date 1/3/96
------------------- -------------------
<PAGE> 1
EXHIBIT 4.3
HEADS OF AGREEMENT
This Heads of Agreement is made and entered into this 25th day of March,
1996, by and between CSL LIMITED A.C.N. 051588348, a __________ company located
in Parkville, Victoria, Australia ("CSL") and THERAPEUTIC ANTIBODIES INC, a
Delaware corporation located in Nashville, Tennessee, USA ("TAb").
1. TAb has developed and is the sole owner of all worldwide right, title,
and interest in and to polyclonal antibody products for treatment of bites of
snakes and other venomous creatures, more particularly described in Schedule 1
below (the "Products").
2. TAb previously agreed to appoint F.H. Faulding & Co. Limited ("FHF")
for registration services and as exclusive distributor with respect to certain
Products in Australia, and TAb is using its best efforts to terminate such
appointment.
3. TAb has requested that CSL conduct clinical trials and obtain
registration and marketing approvals for the Products from the relevant health
authorities in Australia and the other territory referred to in Schedule 2
attached (collectively, the "Territory").
4. TAb and CSL have agreed to negotiate in good faith a definitive
agreement pursuant to which CSL shall conduct clinical trials, obtain
registration and marketing approvals, and distribute the Products in the
Territory. Pending negotiation and execution of such a definitive agreement and,
contingent upon CSL's receipt of notice from TAb of the termination of the
agreement referred to in Section 2 between FHF and TAb, CSL agrees to conduct
and complete such clinical trials as soon as reasonably possible after review
and acceptance by CSL of the draft CTX application and clinical program, to
support financially such clinical trials at its expense and to use all
reasonable endeavors to obtain all necessary, appropriate, and desirable
registration and marketing approvals for the Products promptly from the relevant
health authorities for treatment of snake bites in the Territory at its cost on
and subject to the following terms and conditions:
(a) TAb shall submit a clinical protocol to CSL for approval by CSL
before CSL begins to conduct clinical trials;
(b) TAb shall at its cost promptly provide CSL with relevant information
in relation to the Products, as it becomes aware of the same from
time to time, including information relating to efficacy, safety,
and any adverse reactions;
<PAGE> 2
(c) TAb shall manufacture and ship Products free of charge for the
clinical trials in vials with temporary labels. All Products to be
used in the clinical trials shall be shipped to CSL for distribution
to the various sites of the clinical trials, and careful, detailed
logs of all of the shipments of Products shall be maintained by CSL.
CSL shall be solely responsible for final labelling of containers of
the Products during clinical trials but must have the prior written
approval of TAb regarding the format of such labels before using
such labels;
(d) CSL shall be solely responsible for paying for, conducting, and
monitoring clinical studies necessary for the registration of the
Products in the Territory, but shall consult with TAb in the
selection of the clinical centers to be used for the clinical
trials. CSL shall assure that all clinical trials are conducted in
accordance with all applicable governmental requirements designed to
insure acceptability of clinical data (i.e., Good Clinical
Practices). It is agreed that Good Clinical Practices shall include,
but not be limited to, the practices referred to in Schedule 3;
(e) If TAb and CSL do not enter into the Clinical Trials, Registration,
and Distribution Agreement (defined below), TAb shall reimburse CSL
for all documented, actual, and reasonable expenses that were
previously approved by TAb and incurred by CSL under this Heads of
Agreement;
(f) TAb shall indemnify and hold harmless CSL, its subsidiaries and
affiliates and their officers, directors, employees and agents from
all loss, liability, or expense, including attorneys' fees, arising
from any claim, cause of action or judgment based on any act or
omission of TAb, its agents and employees, including any claim,
cause of action or judgment arising from the Products, their use or
effects, provided however that the foregoing shall not apply if the
claim is caused by the negligence, recklessness or wilful action or
inaction of CSL; and
(g) CSL shall indemnify and hold harmless TAb, its subsidiaries,
affiliates and their officers, directors, employees, and agents from
all loss, liability, or expense, including attorneys' fees arising
from any claim, cause of action or judgment based on the negligence,
recklessness or wilful action or inaction of CSL, its agents or
employees relating to its obligations under the terms of this
Agreement.
5. TAb and CSL shall negotiate in good faith a more detailed agreement to
pursue the clinical trials and obtain the registration and marketing approvals
from the relevant health authorities for distribution of the Products in the
Territory (the "Clinical
2
<PAGE> 3
Trials, Registration, and Distribution Agreement") on and subject to the
following terms and conditions:
(a) TAb shall at its cost promptly supply CSL with a draft CTX
application and all other information, data, and dossiers in its
possession, custody, or control relating to the Products used to
obtain the registration and marketing approvals in the Territory.
(b) At the completion of the clinical trials, CSL shall prepare and file
with the relevant governmental authorities all documents required
for registration of the Products in the Territory and shall pay all
necessary registration fees.
(c) TAb and CSL shall negotiate in good faith regarding manufacturing of
the Products for sale in the Territory with consideration given to
the most appropriate use of facilities available to TAb and CSL.
(d) CSL shall have an exclusive right to distribute the Products in the
Territory. On sales of Products in the Territory, CSL and TAb will
divide the gross profit ***************************. Gross profit
shall be calculated as CSL's net sales revenue less the agreed
Product cost as determined by TAb and CSL beforehand. CSL's net
sales revenue shall equal the gross sales price received by CSL from
its customers, less trade discounts, taxes, and distribution costs.
(e) CSL shall pay TAb the following amounts upon the conclusion of the
following events:
<TABLE>
<S> <C>
Signing the Clinical Trials, Registration, and
Distribution Agreement A $********
First completion of the clinical trials
in a country in the Territory A $********
First grant of marketing approval in a
country in the Territory A $********
Completion of pricing negotiations for
initial sales of a country in the Territory A $********
-----------
TOTAL A $********
</TABLE>
Such payments shall be creditable against a maximum of ******
percent (**%) of TAb's earned proceeds pursuant to Section 5(d)
above in the first ****** (**) years
3
<PAGE> 4
of marketing the Products in the Territory pursuant to the Clinical
Trials, Registration and Distribution Agreement.
(f) CSL shall provide financial assistance to TAb for establishing
animal flocks for commercial purposes in order to build sufficient
inventories of the Products. The level of this Financial assistance
will be agreed by both parties at the time the flocks are
established.
(g) The Clinical Trials, Registration, and Distribution Agreement will
operate from its date of execution until ***** (**) years after the
date on which a Product First receives marketing approval in any
country of the Territory. Thereafter, it will be renewed for
successive ***** (**) year terms unless either party provides sixty
(60) days notice prior to expiration of a term of its intent not to
renew. Termination rights will be available to either party upon
reasonable notice if unexpected delays (as reasonably determined in
good faith) occur in the effort to receive marketing approval for
any Products in the Territory.
(h) CSL and TAb agree to complete development of other Australian
antivenoms with both TAb and CSL equally sharing the product
development costs based upon a mutually agreed budget. Such
development costs would not include the cost of clinical trials
unless TAb and CSL subsequently reach an agreement to address such
costs.
(i) CSL and TAb shall explore opportunities to collaborate in other
areas, including:
applying TAb's technology to other CSL antibody-based products;
research and development of new TAb products;
lyophilization and vialing of appropriate TAb products processed in
Australia; and
commercialization of the TAb product range in markets not covered by
existing agreements between TAb and third parties.
(j) Either party shall be able to terminate the Clinical Trials,
Registration, and Distribution Agreement upon reasonable notice if
(i) the Products are not more effective, as measured by objective
criteria, than existing antivenom products that are competitive with
the Products, and (ii) Product sales in the
4
<PAGE> 5
Territory fall short of reasonable commercial expectations, as more
fully specified in the Clinical Trials, Registration, and
Distribution Agreement.
6. All materials, documents, and information generated through the
conduct of the clinical trials, registration, or distribution efforts
(collectively, the "Materials") are and shall be Confidential Material of TAb
within the meaning of the Mutual Non-Disclosure Agreement between CSL and TAb,
dated December 13, 1995, and shall only be used for the purposes referred to in
this Heads of Agreement or as otherwise approved by TAb. All Materials and
registrations and approvals obtained by CSL hereunder shall be the sole and
exclusive property of TAb.
7. The parties shall use all reasonable endeavors to negotiate and enter
into the Clinical Trials, Registration and Distribution Agreement for the
Products as soon as practicable, but in any event within a period of ****** (**)
******** from the date of this Heads of Agreement or such longer period as the
parties may agree to (the "Negotiation Period"). All such negotiations shall be
conducted in good faith with a view to establishing a long-term relationship
between the parties not only in relation to the Products but generally.
8. Except for rights granted to FHF, which TAb is currently using its
best efforts to terminate, TAb shall not grant inconsistent rights in relation
to the Products to any third party for the Territory during the Negotiation
Period, and shall ensure that no third parties under its control grant any such
rights.
9. Except for existing consulting agreements, the terms of which have
been disclosed to TAb, CSL has not entered into and shall not, during the
Negotiation Period, enter into any agreement with any third party in relation to
products that are competitive or would be competitive with the Products in the
Territory.
10. The parties will consult with each other before issuing any press
release or otherwise making any public statement with respect to the subject
matter of this Heads of Agreement, and neither of them shall issue any such
press release or make any such public statement without the prior consent of the
other, except as may be required by law.
11. The provisions set forth in paragraphs 4,6,7,8,9,10, and 12 of this
Heads of Agreement shall be legally binding obligations of the parties. The
remaining portions are intended only as guidelines for the future negotiation of
binding and enforceable agreements and are not intended to and shall not
constitute binding legal obligations, which shall only arise upon the execution
and delivery of the Clinical Trials, Registration and Distribution Agreement. In
the event TAb is unable to obtain the termination agreement referred to in
Section 2 above before expiration of the Negotiation Period, the parties will
negotiate in good faith an agreement that does not include distribution rights
in Australia.
5
<PAGE> 6
12. This Heads of Agreement shall be governed by and construed in
accordance with the laws of the State of Tennessee of the United States of
America.
IN WITNESS WHEREOF, each of the parties has caused this Heads of
Agreement to be executed in duplicate originals by its duly authorized
representative on the date fist set forth above.
CSL Limited Therapeutic Antibodies Inc
By: /s/ S. McLesh By: /s/ Martin S. Brown
-------------------------- ---------------------------
Name: Mr. S. McLesh Name: Martin S. Brown
------------------------ -------------------------
Title: General Manager Title: Chairman
----------------------- ------------------------
By: /s/ P. Tucky By: /s/ A.J. Kazimi
-------------------------- ---------------------------
Name: P. Tucky Name: A.J. Kazimi
------------------------ -------------------------
Title: Company Secretary Title: President
----------------------- ------------------------
- ---------------
* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.3.
6
<PAGE> 7
SCHEDULE 1
PRODUCTS
Brown Snake Antivenom
SCHEDULE 2
TERRITORY
Australia
Papua New Guinea
SCHEDULE 3
GOOD CLINICAL PRACTICES
(1) All individuals who conduct clinical trials (i.e., Investigators) must be
qualified in accordance with applicable laws or regulations.
(2) All patients at the clinical trials must sign a written informed consent
approved by the applicable Institutional Review Board ("IRB") or
equivalent prior to enrolling in the clinical trials.
(3) A duly constituted IRB must review and approve the protocol, protocol
amendments, informed consent, and advertisements for patients.
(4) Case report forms ("CRFs") and other written material shall be
distributed to the various sites of the clinical trials, and detailed
logs shall be maintained for these distributions.
(5) Independent monitors shall be selected to review performance of clinical
trials if such monitors are required. CSL shall be responsible for the
selection of such independent monitors to audit various clinical sites
after consultation with TAb if applicable laws and regulations contain
such a requirement
<PAGE> 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 F. H. Faulding & 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 Brown 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.
<PAGE> 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 F. H. Faulding & Co. Limited
By: /s/ Martin S. Brown 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
<PAGE> 3
SCHEDULE 1.1
THE PRODUCTS
a. Digitalis Overdose Antidote ("DigiTab")
b. Tricyclic Anti-depressant Antidote ("TriTAb")
c. Sri Lankan Anti-venin ("PulchellaTAb")
<PAGE> 4
EXHIBIT A
***************************
Dr. **********************************, Northern Territory
Dr. **********************************, Western Australia
Dr. *************************************************, New South Wales
Dr. **************************************, Parkville, Victoria
Professor *************************************, Brisbane, Queensland
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.
