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EXHIBIT 4.2
February 13, 1996
Swedish Orphan AB
Xxxxxxxxx 00, 0xx.
000 00 Xxxxxxxxx
Xxxxxx
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 "X. xxxxx 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 X.xxxxx 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
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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.
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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/ Xxxxxx X. Xxxxx
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Xxxxxx X. Xxxxx, Chairman
Date: 2/14/96
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Accepted and Agreed:
Swedish Orphan AB
By: /s/ Lars-Uno Larsson
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Lars-Uno Larsson, President
Date: 1/3/96
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* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.2.
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APPENDIX C
MINIMUM SALES: (Scandinavia) in Vials
Product 1996 1997 1998
------- ---- ---- ----
ViperTAb(TM) *** *** ***
DigiTAb(TM) to be agreed
TriTAb(TM) to be agreed
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* The Registrant has requested confidential treatment from the Securities
and Exchange Commission for the marked portions of this Exhibit 4.2.
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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
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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.
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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/ Xxxxxx X. Xxxxx /s/ Lars-Uno Larsson
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Title Chairman Title President
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Date 2/14/96 Date 1/3/96
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