EXHIBIT 10.3
AMENDMENT NO. 2
TO
THE EXPANDED AND AMENDED THYMOSIN ALPHA 1 LICENSE, DISTRIBUTORSHIP AND
SUPPLY AGREEMENT
SIGNED BY AND BETWEEN SCICLONE PHARMACEUTICALS INTERNATIONAL LTD
AND
SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SPA ON MARCH 3, 2000
AS AMENDED BY THE PARTIES WITH AMENDMENT NO. 1 ON DECEMBER 19, 2001
(HEREINAFTER "THE AGREEMENT")
SCICLONE PHARMACEUTICALS INTERNATIONAL LTD. ("SPIL"), a Cayman Islands business
entity which is a wholly-owned subsidiary of SciClone Pharmaceuticals, Inc.
("SCLN"), a Delaware corporation;
and
SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. ("Sigma-Tau"), an Italian
corporation having offices at xxxxx Xxxxxxxxxxx 00, 00000 Xxxx, Xxxxx.
SPIL AND SIGMA-TAU HEREBY AGREE TO AMEND ARTICLE 5 (DEVELOPMENT AND CLINICAL
TRIALS), OF THE AGREEMENT (IN ORDER TO ADD A NEW SECTION 5.8) AS FOLLOWS:
5.8 Licensed Product, Pegaysy(R) and Copegus(R) Clinical Trials. Subject to but
without change to other provisions of Article 5, Sigma-Tau and SPIL agree to
conduct a 550 patient hepatitis C trial (the "Trial") under the following terms:
(a) Sigma-Tau and SPIL agree, upon signature of this Amendment, to form a
steering committee (the "Steering Committee") consisting of at least four
appropriate and mutually acceptable individuals, two from Sigma-Tau and two from
SPIL. The role of the Steering Committee is to oversee the conduct and progress
of the Trial with the intention to move the Trial forward as fast as appropriate
and, when necessary, to make recommendations to both SPIL and Sigma-Tau
management for changes or improvements. The Steering Committee will convene
formally a minimum of four times at regularly scheduled telephonic or
face-to-face meetings each calendar quarter (face-to-face meetings will take
place at least twice each calendar year that the Trial is in process) to discuss
the conduct and progress of the Trial. Minutes of the meetings will be sent to
the appropriate levels of both Sigma-Tau and SPIL management.
(b) Sigma-Tau's Obligations
Subject to: (1) SPIL providing to Sigma-Tau the Licensed Product and also
providing the products Pegaysy(R) and Copegus(R) manufactured by X. Xxxxxxxx -
Xx Xxxxx Ltd. of Basel, Switzerland ("Roche"); (2) the parties' mutual agreement
on the design and objectives of the clinical program and the clinical protocol
for the Trial; (3) regulatory authorization, if needed, to commence the Trial;
and (4) other necessary authorizations and procedures customary and normal to
the conduct of a clinical study comparable to the Trial in accordance with
[****], Sigma-Tau shall use its reasonable best efforts to conduct a
comprehensive minimum enrollment 550 patient phase 3 clinical Trial in the
Territory and in the additional countries of Poland, Hungary, the Czech Republic
and other countries to be approved in writing by SPIL from time to time, which
is designed, implemented and monitored according to [****] involving the
Licensed Product in combination with the products Pegaysy(R) and Copegus(R) in
the treatment of hepatitis C patients that have failed to respond to prior
therapy (non-responders). Subject to the foregoing conditions, unless otherwise
agreed by the parties in writing, Sigma-Tau agrees to the following development
obligations with respect to the Trial:
(i) to conduct the Trial as a multi-country,
multi-center study; the number of target sites, Principal Investigator, other
investigators, will be mutually agreed by the parties;
(ii) to enroll the first patient in the Trial as soon as
practically possible during the year 2004;
(iii) to use its reasonable best efforts to complete the
enrollment of at least 550 patients in the Trial by [****];
(iv) to fully and in a timely manner fund the Trial,
subject to SPIL making the payments and supplying the products as provided for
in (c) below; and
(v) Sigma-Tau and its Affiliates shall keep SCLN
informed of the progress of the Trial and shall provide SCLN with quarterly
summary reports of the results of the Trial. Sigma-Tau and its Affiliates shall
give SCLN access to the clinical reports and patient histories concerning the
Trial. Sigma-Tau will provide to SCLN and to SPIL, for regulatory and marketing
purposes and with the intention of assisting SCLN and SPIL in the submission of
such regulatory filings as SCLN and SPIL deem appropriate, the data resulting
from the Trial when and as it is available.
(c) SPIL'S Obligations
In furtherance of the Trial:
(i) SPIL shall supply free of charge to Sigma-Tau the
Licensed Product, placebo and the Roche products Pegaysy(R) and Copegus(R) in
the amounts needed for the Trial;
*Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
(ii) SPIL shall make payments to Sigma-Tau up to a total
of US $2,500,000 (U.S. Dollars two million five hundred thousand) to assist in
paying for incurred or anticipated costs and expenses associated with the Trial,
as follows:
(1) an initial payment equal to [****] upon
[****];
(2) a payment equal to [****] upon [****];
(3) a payment of [****] per each patient, who is
enrolled and injected with active drug substance, up to a cumulative total of
[****], paid [****]; and
(4) a milestone payment equal to [****] upon
[****].
(d) SCLN and Roche have entered into that certain Material Transfer Agreement
attached hereto as Annex I (the "Roche MTA"). In concluding the Trial and acting
as the Sponsor as defined in the Roche MTA, Sigma-Tau hereby agrees to perform
the Trial in accordance with (i) the Protocol (which Protocol shall be approved
by SCLN, SPIL, Sigma-Tau and Roche), and (ii) the terms of the Roche MTA.
Further, Sigma-Tau agrees to be bound by the same confidentiality and non-use
terms applicable to SCLN under the Roche MTA.
Except only as set forth above, all of the provisions of the Agreement shall
remain unchanged and in full force and effect.
*Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
SIGNATURE PAGE
IN WITNESS WHEREOF, THE PARTIES HERETO HAVE CAUSED THIS AMENDMENT AGREEMENT TO
BE DULY EXECUTED EFFECTIVE AS OF THE DATE LAST WRITTEN BELOW.
SCICLONE Pharmaceuticals SIGMA-TAU Industrie
International Ltd. Farmaceutiche Riunite SpA
__________________________________ __________________________________
By: By:
Title: Title:
Date: Date:
