1
EXHIBIT 99.1
EXPANDED AND AMENDED THYMOSIN ALPHA 1 LICENSE, DISTRIBUTORSHIP
AND SUPPLY AGREEMENT
This Expanded and Amended Thymosin Alpha 1 License, Distributorship and
Supply Agreement (the "Agreement") is made and entered into effective as of
March 3, 2000 (the "Effective Date"), by and between:
(i) SCICLONE PHARMACEUTICALS INTERNATIONAL LTD. ("SPIL"), a Cayman
Islands business entity which is a wholly-owned subsidiary of SciClone
Pharmaceuticals, Inc. ("SCLN"), a California corporation; and
(ii) SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. ("Sigma-Tau"), an
Italian corporation having offices at xxxxx Xxxxxxxxxxx 00, 00000 Xxxx, Xxxxx.
Recitals
A. SPIL and/or its Affiliates develops, manufactures, distributes and
sells the prescription pharmaceutical product, Thymosin Alpha 1, Injection, as
further described in this Agreement.
B. Sigma-Tau possesses significant scientific, business and marketing
expertise and capabilities with respect to the research, development and
commercialization of human injectable pharmaceutical products in the Territory,
as further described in this Agreement.
C. SPIL and Sigma-Tau desire to expand and amend their long-term
cooperative Thymosin Alpha 1 License, Distributorship and Supply Agreement,
dated as of April 12, 1999, for the development and marketing of Thymosin Alpha
1, Injection in Italy, Spain and Switzerland and this Agreement supersedes and
replaces the April 12, 1999 agreement in its entirety.
NOW, THEREFORE, in consideration of the mutual representations,
covenants and undertakings set forth herein, and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, SPIL
and Sigma-Tau agree as follows:
ARTICLE 1
DEFINITIONS
The following terms, as used in this Agreement, shall have the meanings
set forth in this Article:
"AFFILIATE" means any person, firm or corporation which, directly
or indirectly, through one or more intermediaries, controls, is controlled by,
or is under common control with, a party. "Control" means the legal or
beneficial ownership of 50% or more of the voting or equity interests or the
power or right to direct the management and affairs of the business (including
acting as the general partner of a limited partnership).
2
"CONFIDENTIAL INFORMATION" shall mean any and all proprietary or
confidential information of SPIL or its Affiliates, or Sigma-Tau, with respect
to Licensed Product which may be exchanged between the parties at any time and
from time to time during the term of this Agreement. Information shall not be
considered confidential to the extent that it:
(a) is publicly disclosed through no fault of any party
hereto, either before or after it becomes known to the receiving party; or
(b) was known to the receiving party prior to the date of
this Agreement, which knowledge was acquired independently and not from the
other party hereto (or such party's employees); or
(c) is subsequently disclosed to the receiving party in
good faith by a third party who has not received it, directly or indirectly,
from the disclosing party.
Nothing herein will prevent either party from disclosing
all or part of the Confidential Information to any administrative or judicial
authority if so ordered by such authorities in compliance with the applicable
laws.
The parties agree that the terms and conditions of this
Agreement shall be deemed to be Confidential Information.
"EFFECTIVE DATE" shall be the date set forth in the first
paragraph of this Agreement.
"EMEA" shall mean the European Agency for the Evaluation of
Medicinal Products.
"FIELD" shall mean all ethical pharmaceutical uses.
"FORCE MAJEURE" shall mean an event that shall have prevented,
restricted or interfered with the performance by a party of any of its
obligations under this Agreement if such event occurs by reason of any act of
God, flood, fire, explosion, breakdown of plant, strike, lockout, labor dispute,
casualty, accident or illness, war, revolution, civil commotion, acts of public
enemies, blockage or embargo, any injunction, law, order, proclamation,
regulation, ordinance, demand or requirement of any government or of any
subdivision, authority or representative of such government, inability to
procure or use materials, labor, equipment, transportation, or energy sufficient
to meet manufacturing needs without the necessity of allocation, or any other
cause whatsoever, whether similar or dissimilar to those above enumerated,
beyond the reasonable control of such party, if the party affected shall have
used its best efforts to avoid such condition; provided, however, that nothing
herein shall obligate an affected party to settle a strike or other labor
dispute against its will; and provided further, a party's lack of available
financial resources shall not constitute a Force Majeure.
"ICH GUIDELINES" shall mean the `Good Clinical Practice:
Consolidated Guideline' (ICH E6) adopted by the International Conference on
Harmonization, 1 May 1996.
2
3
"IMPROVEMENTS" shall mean any and all improvements to or
enhancements of the SPIL Technology, whether or not patentable, including,
without limitation, application or indication improvements and/or enhancements,
new uses, indications, modifications, fragments, analogs and synthetic
derivatives of Licensed Product, as well as combinations of Licensed Product and
other active ingredients, and combinations of all of the foregoing, and any
rights relating to the protection of trade secrets and any rights analogous
thereto, appurtenant to any such improvements or enhancements, which are made or
conceived by or on behalf of Sigma-Tau or its Affiliates or by SPIL or its
Affiliates or acquired by SPIL or its Affiliates or Sigma-Tau or its Affiliates
during the term of this Agreement.
"INFLUENZA INDICATION" shall mean the use of Licensed Product in
the Territory as an influenza vaccine adjuvant.
"INVENTIONS" shall mean any and all patented or unpatented ideas,
inventions or discoveries relating to the Licensed Product which are made,
created, conceived or reduced to practice by or on behalf of Sigma-Tau or its
Affiliates or by SPIL or its Affiliates or acquired by SPIL or its Affiliates
during the term of this Agreement, and any and all patent, patent application
and patent rights, and any substitutions, divisionals, continuations,
continuations-in-part, renewals, reissues, confirmation of registrations, and
extensions thereof which are appurtenant to such inventions or discoveries.
"LICENSED PRODUCT(s)" shall mean finished Thymosin alpha 1 and all
Improvements.
"NET SALES" shall mean the gross receipt from the sale by
Sigma-Tau or its Affiliates of the Licensed Product less any of the following
items which Sigma-Tau or its Affiliates can verify have been actually paid or
credited by Sigma-Tau or its Affiliates with respect to the sale of the Licensed
Product:
(a) shipping expenses, as actually paid to Sigma-Tau or its
Affiliates by the customer and included in the gross sales price;
(b) discounts actually credited against the gross sales
price;
(c) amounts actually repaid or credited by reason of
rejection, defects or returns or because of retroactive price reductions; and
(d) sales and other excise taxes, use taxes, tariffs,
export license fees and duties actually paid or allowed.
"OTHER INDICATIONS" shall mean the use of Licensed Product for
those certain other indications which may be mutually approved in writing in the
future by both SPIL and Sigma-Tau for addition to this Agreement.
"PATENT RIGHTS" shall mean those patents and patent applications
listed on Exhibit A to this Agreement and any and all patents issuing thereon.
The term "patents" as used in this Agreement shall include, without limitation,
all substitutions, continuations, continuations-in-part (to the extent the
invention described in the continuation-in-part application
3
4
claims subject matter embraced by the original application), divisions, reissues
and extensions filed in the Territory. Patent Rights shall also include those
patent applications filed by SPIL or its Affiliates with respect to any
Improvements.
"SCICLONE ITALY" shall mean SciClone Pharmaceuticals Italy Srl.
"SIGMA-TAU 2.0 MG HSA INFLUENZA AUTHORIZATION" shall mean the
Italian Ministry of Health marketing authorization held by Sigma-Tau for
Influenza using 2.0 mg HSA formulation of Licensed Product. (AIC#028640011)
"SPECIFICATIONS" shall mean the specifications for the Licensed
Product, which, subject to approval of the Ministry of Health in each country of
the Territory, may be modified from time to time by SPIL at its sole option and
discretion upon reasonable prior notice to Sigma-Tau. The Specifications in
effect as of the Effective Date are attached as Exhibit B to this Agreement.
"SPIL TECHNOLOGY" shall mean the Patent Rights, the Technical
Information and the Improvements.
"TECHNICAL INFORMATION" shall mean all of the non-patented
know-how, technology, Confidential Information, data, registration dossiers,
clinical data, and trade secrets belonging to SPIL or its Affiliates concerning
the development and commercial exploitation of the Licensed Product.
"TERRITORY" shall mean the following countries: Austria, Belgium,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
"THYMOSIN ALPHA 1" shall mean the ethical pharmaceutical product
specifically described in the Specifications attached as Exhibit B to this
Agreement.
"TRADEMARK RIGHTS" shall mean those trademarks, trademark
registrations and trademark applications listed on Exhibit C to this Agreement
and any and all trademark registrations issuing thereon.
ARTICLE 2
LICENSE
2.1 Grant of License. Subject to SPIL's reserved rights in
Sections 2.3 and 2.4 and the terms and conditions of Section 4.14, SPIL hereby
grants to Sigma-Tau (a) an exclusive license to develop, distribute and sell
Licensed Product in the Field in the Territory, (b) an exclusive license to
practice and use the SPIL Technology to research and develop ethical
pharmaceutical products, including Improvements, in the Field in the Territory
and (c) an exclusive license to manufacture Licensed Product in the Territory,
solely pursuant to the terms and conditions of Section 4.14.
4
5
2.2 Sublicenses. The grant of the license set forth in Section 2.1
does include the right to sublicense to one (1) sublicensee in each country in
the Territory, provided, however, that Sigma-Tau's right to sublicense pursuant
to this Section 2.2 is subject to SPIL's prior written consent, on a country by
country basis, which consent will not be unreasonably withheld or delayed;
provided, further, however, that such consent shall not be required in the event
Sigma-Tau elects to sublicense its rights hereunder to its Affiliates.
2.3 No Manufacturing License. The grant of license set forth in
Section 2.1 does not include any manufacturing rights with respect to Licensed
Product, except pursuant to the terms and conditions set forth in Section 4.14.
2.4 Retained Rights. Notwithstanding Section 2.1, in Italy, SPIL
and its Affiliates retain the license rights to develop, practice and use
Licensed Product and the SPIL Technology, including the holding of a
registration of Licensed Product , for all indications, with the Italian
Ministry of Health, for the sole purpose of using Licensed Product and the SPIL
Technology to support distribution and sales of Licensed Product from Italy to
markets outside the Territory.
2.5 Grant of License to Sigma-Tau's Data and Documents. Sigma-Tau
hereby grants to SPIL and its Affiliates an exclusive, even as to Sigma-Tau,
royalty-free, perpetual license, with the right to sublicense, to use outside
the Territory (1) all data, including but not limited to, preclinical, clinical,
CMC (chemistry, manufacturing, control), pharmacokinetic and pharmacological
test and analytical data and (2) documents, including but not limited to
registration dossiers, arising out of or resulting from the Hepatitis C Trial
(as defined in Section 5.1 hereof) and Sigma-Tau's or its Affiliates' or
sublicensees' performance under this Agreement. Sigma-Tau will make available to
SPIL any and all such data and documentation it generates or acquires, in its
original form, and whenever available together with an English translation
thereof.
2.6 Term of License. The term of the license granted to Sigma-Tau
in Section 2.1 shall be for the term set forth in Section 10.1 herein.
2.7 No Further Licenses. Sigma-Tau acknowledges and agrees that
the scope of license granted hereunder is specifically and expressly defined in
Section 2.1, and no additional licenses are granted or implied hereunder.
2.8 Proprietary Rights. All right, title and interest in and to,
and ownership of, the SPIL Technology, Licensed Product, Inventions,
Improvements and any other material provided by SPIL to Sigma-Tau shall remain
at all times exclusively in SPIL, SCLN or SciClone Italy; and Sigma-Tau shall
not acquire any right, title, or interest in any of the foregoing, except
however for (i) the licenses set forth herein; and (ii) for the ownership of
such quantities of finished product of the Licensed Product which Sigma-Tau
purchases from SPIL from time to time pursuant to Article 4 hereof. To the
extent Sigma-Tau may possess any intellectual property rights in any
Improvement, such rights will be governed by Section 5.6 (c) and the other terms
of this Agreement.
5
6
2.9 Sigma-Tau 2.0 Mg HSA Formulation Authorization. Except for the
rights set forth in the letter agreement dated February 26, 1998 between SCLN
and Sigma-Tau (Attached as Exhibit D), the parties acknowledge that Sigma-Tau
owns all right, title and interest in and to the Sigma-Tau 2.0 Mg HSA Influenza
Authorization, and SPIL shall not acquire any right, title, or interest in the
Sigma-Tau 2.0 Mg HSA Influenza Authorization by virtue of this Agreement.
ARTICLE 3
ROYALTIES
3.1 Royalties. So long as Sigma-Tau pays at least [****] per vial
for Licensed Product as specified in Section 4.5 hereof, Sigma-Tau shall not be
obligated to pay any royalties under this Agreement. As to any Licensed Product
which Sigma-Tau sells to a third party for which the [****] specified in Section
4.5 results in a price less than [****] per vial, then said deficit below [****]
shall be paid either (i) as an additional purchase price pursuant to Section
4.5, or (ii) as a royalty pursuant to this Section 3.1. If paid as a royalty,
such royalty shall be payable on at least a biannual basis within sixty (60)
days following the end of the six (6) months covering sales on which the
royalties were based.
ARTICLE 4
SUPPLY OF PRODUCTS; PACKAGING; TRADEMARKS
4.1 Exclusive Supplier. SPIL or its designees shall be the sole
and exclusive source from which Sigma-Tau, its Affiliates and sublicensees shall
purchase Licensed Product, regardless of its presentation or formulation. SPIL
agrees to use its commercially reasonable efforts, based on its manufacturing
contractors' facilities and capabilities, to supply Sigma-Tau's its Affiliates'
and sublicensees' requirements for Licensed Product in the Territory.
4.2 Purchase Orders. During the term of this Agreement, Sigma-Tau,
its Affiliates and sublicensees shall purchase and SPIL or its designees shall
supply such quantities of Licensed Product as are set forth on written purchase
orders placed by Sigma-Tau, its Affiliates or sublicensees, as the case may be,
and accepted by SPIL under this Agreement.
4.3 Acceptance. Within fourteen (14) days of SPIL's receipt of a
purchase order for Licensed Product from Sigma-Tau, its Affiliate or
sublicensee, SPIL will advise Sigma-Tau its Affiliate or sublicensee, as the
case may be, in writing of its acceptance or non-acceptance of said purchase
order.
4.4 Forecasts.
(a) Sigma-Tau shall furnish to SPIL on a quarterly basis,
sixty (60) days before January 1, April 1, July 1 and October 1 of each year, a
twelve (12) month rolling annual forecast which sets forth Sigma-Tau's good
faith best estimate of all of the quantities of Licensed Product for which
Sigma-Tau, its Affiliates and sublicensees expect to place purchase orders
during each twelve (12)-month period. The forecast for the first quarter in each
forecast
*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.
6
7
shall be binding on Sigma-Tau, its Affiliate or sublicensee, as the case may be,
and SPIL; the forecast for the second quarter in each forecast shall be binding
on Sigma-Tau and SPIL plus or minus 50%; and the forecast for the third and
fourth quarters in each forecast shall not be binding but shall be good faith
best estimates.
(b) Within fifteen (15) days of SPIL's receipt of a
Sigma-Tau annual forecast, SPIL will advise Sigma-Tau in writing of its
acceptance or its determination that a mutually agreed adjustment of the
forecast be negotiated between the Parties in good faith to reflect market
demand in the Territory. Such negotiation shall occur as expediently as
possible.
4.5 Price. Subject to the provisions in Section 4.7 below, the
purchase price for the finished vial of Licensed Product shall be the greater
of:
(a) [****] per vial, for the 1.6 mg mannitol formulation;
or
(b) [****] at which Sigma-Tau or its Affiliates sell a
particular vial of Licensed Product to buyers. Sigma-Tau shall provide to SPIL
complete information and records as to its and its Affiliates sales of Licensed
Product in the Territory, including public price.
4.6 New Presentation or Formulation. If Sigma-Tau, its Affiliates
or sublicensees sell Licensed Product in a presentation or formulation different
from the 1.6 mg mannitol formulation, then the [****] shall still apply, and the
[****] minimum price shall be adjusted and established by SPIL to be
substantially equivalent and comparable in relation to the differences between
the actual presentation or formulation and the assumed 1.6 mg mannitol
formulation.
4.7 Adjustment in Pricing. Notwithstanding the provisions in
Section 4.5 above, SPIL agrees to meet and negotiate in good faith with
Sigma-Tau on a country by country basis, the pricing of a vial of Licensed
Product, including the minimum price and an analysis of the movement between the
Euro and the US dollar, at such time when the reimbursable price for the
Licensed Product is established in that country in the Territory.
4.8 Delivery Terms. The delivery of Licensed Product to be sold to
Sigma-Tau, its Affiliates or sublicensees by SPIL shall be C.I.P. Sigma-Tau's
warehouse in Pomezia, Italy, unless SPIL and Sigma-Tau agree otherwise in
writing. The dates for delivery of purchase orders placed shall be set for each
order as agreed upon by the parties.
4.9 Payment Terms - Timing. All purchase orders provided by
Sigma-Tau, its Affiliates or sublicensees to SPIL pursuant to this Agreement
shall be paid for as follows:
(a) The purchase price shall be due and paid in cash within
sixty (60) days after delivery of the Licensed Product so ordered.
(b) Any sums which are not paid when due shall bear a late
payment charge equal to the prime rate +2% as published in the Wall Street
Journal on the due date of the invoice per annum while the sum remains
delinquent; and Sigma-Tau, its Affiliates or sublicensees, as the case may be,
shall pay said late payment charge within ten days after a
*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.
7
8
written demand is made upon Sigma-Tau, its Affiliates or sublicensees, as the
case may be, for said payment.
4.10 Specifications. The Licensed Product delivered to Sigma-Tau,
its Affiliates or sublicensees pursuant to this Agreement shall be accompanied
by a certificate of an appropriate employee of SPIL or SPIL's designated
supplier of Licensed Product, certifying that the Licensed Product meets the
Specifications for the Licensed Product.
4.11 Trademarks. SPIL has rights to trademark registrations and
applications for ZADAXIN for the Licensed Product in the Territory as indicated
in Exhibit C and markets and sells the Licensed Product elsewhere under the
ZADAXIN trademark. SPIL grants to Sigma-Tau an exclusive license to use the
ZADAXIN trademark in the Territory for the Licensed Product, provided, however,
that SPIL or its Affiliate, SciClone Italy, shall retain the right to use the
ZADAXIN trademark in Italy for all uses, except sale and distribution of the
Licensed Product in Italy as well as in the other countries in the Territory.
The Trademark Rights which are licensed to Sigma-Tau pursuant to this Section
4.11 are as indicated in Exhibit C. The parties intend that Sigma-Tau, its
Affiliates and sublicensees will market and sell the Licensed Product in the
Territory under the ZADAXIN trademark. All Licensed Product which Sigma-Tau, its
Affiliates and sublicensees market, distribute and/or sell in the Territory
shall be marked with the trademark ZADAXIN, and no other trademark, excepting
only as otherwise set forth herein. In the event that use of the ZADAXIN
trademark is prohibited in any particular country in the Territory, after
diligent efforts are pursued by SPIL and/or Sigma-Tau to obtain such approval,
then and only then may Sigma-Tau, its Affiliates or sublicensees use a different
trademark owned or controlled by Sigma-Tau on the Licensed Product in said
country; and in that event, said different trademark shall be subject to the
prior written approval of SPIL.
4.12 Warning Labels; Packaging and Instructions; Warranties. SPIL
shall provide Sigma-Tau, its Affiliates and sublicensees with samples of SPIL's
warning labels, packaging and use instructions ("package insert") as to the use
of the Licensed Product. Sigma-Tau shall have sole responsibility for
translating any warning labels, packaging and use instructions as to the use of
the Licensed Product into appropriate languages within the Territory. Except for
this translation, and except for inserting Sigma-Tau's, its Affiliates' and
sublicensees' name as the licensee or distributor of the Licensed Product,
Sigma-Tau, its Affiliates and sublicensees may not alter the content of any such
warning labels, packaging and instructions without SPIL's prior written consent.
Sigma-Tau, its Affiliates and sublicensees may not make any warranties with
respect to the Licensed Product in excess of any warranties which may be
provided to Sigma-Tau, its Affiliates and sublicensees by SPIL. 4.13 Patent
Marking. Sigma-Tau, its Affiliates and sublicensees shall xxxx any Licensed
Product (or their containers or labels) with any notice of Patent Rights and/or
Trademark Rights necessary or desirable under applicable laws to enable the
Patent Rights and/or Trademark Rights to be enforced to their full extent in the
Territory.
4.14 Transfer of Manufacturing Rights to Sigma-Tau.
(a) Promptly after execution of this Agreement, Sigma-Tau
will initiate registration of SPIL's US finished Thymosin alpha 1 product with
the appropriate
8
9
regulatory authorities in the Territory as an alternate source of Licensed
Product, to SPIL's European finished Thymosin alpha 1 product.
(b) SPIL shall be obligated to inform Sigma-Tau promptly if
SPIL or its third party manufacturer (1) discontinues production of Licensed
Product or (2) is unable to supply mutually agreed forecast amounts of Licensed
Product for at least three (3) months.
(c) SPIL shall have sixty (60) days from the date Sigma-Tau
receives SPIL's notice of an inability to supply, to remedy and supply any
mutually agreed forecast amounts of Licensed Product.
(d) If SPIL cannot provide sufficient Licensed Product
supply to meet the mutually agreed forecast amounts after the remedy period in
(c) above, Sigma-Tau will be given the right to assume or have a third party
assume manufacture of Licensed Product under terms agreed to in good faith by
SPIL, which agreement shall not be unreasonably withheld or delayed.
(e) In the event that SPIL can partially supply the
mutually agreed forecast amounts of Licensed Product to Sigma-Tau, its
Affiliates or sublicensees, it shall do so on a pro-rata basis, based on
historical Licensed Product purchases made by Sigma-Tau, its Affiliates or
sublicensees.
ARTICLE 5
DEVELOPMENT AND CLINICAL TRIALS.
5.1 Sigma-Tau's Obligations.
(a) Subject to (1) the availability of Licensed Product and
the alpha interferon product, (2) the parties' mutual agreement on the clinical
protocol, (3) regulatory authorization, if needed, to commence the clinical
trial described below, and (4) other necessary authorizations and procedures
customary and normal to the conduct of a clinical trial in the Territory in
accordance with ICH Guidelines, Sigma-Tau shall use its reasonable best efforts
to perform at least one (1) pivotal phase 3 clinical trial in the Territory
either (i) in accordance with ICH Guidelines or (ii) in accordance with
regulatory requirements of a rapporteur country, which country shall be mutually
agreeable to SPIL and Sigma-Tau, and in each case involving the Licensed Product
in combination with alpha interferon for the treatment of Hepatitis C (the
"Hepatitis C Trial") with the primary objective of obtaining for the Licensed
Product either (a) EMEA marketing approval in the Territory or (b) rapporteur
country marketing approval followed by marketing approval in each country in the
Territory, at the most satisfactory governmentally reimbursable price and in the
fastest manner possible. 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 Hepatitis C Trial:
(i) to submit an application to the Principal Ethical
Committee on or before June 30, 2000;
9
10
(ii) to administer the first dose to the first patient
in the Hepatitis C Trial on or before September 30, 2000;
(iii) to administer the first dose to the last patient
in the Hepatitis C Trial on or before July 1, 2001; and
(iv) to administer the last dose to the last patient in
the Hepatitis C Trial on or before July 1, 2002.
The Hepatitis C Trial must be designed, implemented and monitored according to
either ICH Guidelines or regulatory approval requirements of a mutually
agreeable rapporteur country in the Territory. SPIL and Sigma-Tau shall agree in
good faith on the contents and targets of the Hepatitis C Trial in the
Territory. In furtherance of the Hepatitis C Trial, SPIL shall supply [****] to
Sigma-Tau (i) the Licensed Product needed for the Hepatitis C Trial and (ii) the
preclinical and clinical data on the Licensed Product in SPIL's possession which
SPIL determines, based on ICH Guidelines, to be relevant to the Hepatitis C
Trial.
(b) Upon execution of this Agreement, Sigma-Tau agrees to
use reasonable best efforts to obtain and maintain marketing approval for the
sale and distribution of Licensed Product in Switzerland;
(c) SCLN intends to perform a pivotal phase 3 clinical
trial in the United States, which trial is planned to be comparable in size and
scope to the Hepatitis C Trial (the "US Hepatitis C Trial"). Subject to the
parties' mutual agreement on the clinical protocol of the US Hepatitis C Trial,
Sigma-Tau agrees to reimburse SCLN for thirty-five percent (35%) of SCLN's or
its designated Affiliate's costs and expenses associated with the US Hepatitis C
Trial, provided, however, that Sigma-Tau shall not be required to reimburse SCLN
or its designated Affiliate for the cost of alpha interferon or Thymosin alpha 1
required for the US Hepatitis C Trial, which clinical trial materials SCLN or
SPIL shall supply or cause to be supplied. SPIL and its Affiliates and Sigma-Tau
shall agree in good faith on the contents, targets, timing and relevant costs of
the US Hepatitis C Trial. SPIL and its Affiliates shall keep Sigma-Tau informed
of the progress of the US Hepatitis C Trial and shall provide Sigma-Tau with
quarterly summary reports of the results of such trial. SPIL and its Affiliates
shall give Sigma-Tau access to the clinical reports and patient histories
concerning the US Hepatitis C Trial.
5.2 Other Clinical Trials. Sigma-Tau may perform other clinical
trials in the Territory with respect to the Licensed Product upon the mutual
written agreement of Sigma-Tau and SPIL, which approval shall not be
unreasonably withheld or delayed.
5.3 Clinical Trials/Access to Information. Sigma-Tau shall keep
SPIL informed of the progress of any clinical trials involving Licensed Product
and shall provide SPIL with quarterly summary reports of the results of those
trials. Sigma-Tau shall give SPIL access to the clinical reports and patient
histories concerning those clinical trials upon request by SPIL. In case of a
medical emergency involving any Licensed Product, or if required by any
governmental authority to which SPIL is subject, SPIL shall have immediate
access to all protocols, regulatory documentation, and promotional materials,
prepared by or for Sigma-Tau, relating to the use or sale of Licensed Product.
*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.
10
11
5.4 Delivery of Product Information. During the term of this
Agreement, SPIL shall promptly deliver to Sigma-Tau for its use or use by its
Affiliates or sublicensees in the Territory as provided in this Agreement all
pre-clinical and clinical, toxicological, pharmacological and technical data and
information relating to Licensed Product or Improvements in the Territory which
may be generated by or otherwise come into the possession of SPIL (and which
SPIL has the right to release to Sigma-Tau, its Affiliates or sublicensees);
provided, however, that SPIL may first file any patent applications that may be
available with respect to any Improvements to the extent that prior delivery to
Sigma-Tau, its Affiliates or sublicensees of any such data and information would
prejudice the filing of such patent application. Likewise, during the term of
this Agreement, Sigma-Tau, its Affiliates or sublicensees shall promptly deliver
to SPIL for SPIL's use worldwide, all pre-clinical and clinical, toxicological,
pharmacological and technical data and information relating to Licensed Product
and Improvements which may be generated by or otherwise come into possession of
Sigma-Tau, its Affiliates or sublicensees. Sigma-Tau, its Affiliates and
sublicensees shall allow SPIL personnel access for the purposes contemplated by
this Agreement to the clinical reports and patient histories concerning clinical
trials involving Licensed Product conducted by Sigma-Tau, its Affiliates or
sublicensees.
5.5 Publications. Sigma-Tau may publish the discoveries and
findings of Sigma-Tau arising out of its research and development activities
using the SPIL Technology in accordance with standard scientific practices and
policies; provided, however, that if Sigma-Tau desires to submit to any journal,
other publication, conference, symposium, or meeting any paper, abstract,
manuscript, presentation materials or other writing with respect to such
discoveries or findings, then Sigma-Tau shall provide to SPIL a copy of such
publication at least sixty (60) days prior to the date on which Sigma-Tau
intends to submit such publication. If SPIL does not inform Sigma-Tau in writing
on or before the expiration of such sixty- (60) day period that the publication
or presentation of the proposed publication must be delayed in order to obtain
patent protection for the discoveries and findings contained therein, Sigma-Tau
shall be free to publish or present such publication. If SPIL timely informs
Sigma-Tau in writing that publication or presentation of such publication must
be delayed, Sigma-Tau agrees not to publish or present such publication for such
reasonable period as may be requested by SPIL in order to obtain patent
protection for the discoveries and findings contained therein.
5.6 Ownership of Inventions and Improvements.
(a) SPIL or its Affiliates shall be the sole owner of any
Improvements or any other Inventions made by or on behalf of Sigma-Tau, its
Affiliates or sublicensees or SPIL or its Affiliates arising out of the clinical
trials referenced in this Article 5 or otherwise developed by Sigma-Tau, its
Affiliates or sublicensees under this Agreement; provided, however, that in the
event the law of any applicable jurisdiction provides that SPIL or its
Affiliates may not be the sole owner, then SPIL and its Affiliates shall be
granted a perpetual, royalty-free non-exclusive license to use for any purposes,
outside the Territory as well as in Italy subject to Section 2.4, any such
Improvements or Inventions. Sigma-Tau, its Affiliates and sublicensees hereby
irrevocably assign all right, title and interest in and to any intellectual
property rights in any Invention or Improvement arising under this Agreement, to
SPIL or its designee. Sigma-Tau, its Affiliates and sublicensees agree to
execute any documents which may be required in order to effect such an
assignment.
11
12
(b) Sigma-Tau shall retain a perpetual, royalty-free
exclusive license to use for any purposes, within the Territory, except in
Italy, where such license shall be non-exclusive subject to Section 2.4, any
such Improvements or Inventions made by or on behalf of Sigma-Tau or SPIL
arising out of the clinical trials referenced in this Article 5 or otherwise
developed by Sigma-Tau or SPIL under this Agreement, unless this Agreement is
terminated pursuant to Section 10.3 (a) hereof.
(c) If SPIL or its Affiliates or other non-Sigma-Tau
licensees or distributors market and sell Licensed Product in a country outside
the Territory incorporating an Improvement or Invention for which Sigma-Tau
would be deemed an inventor under the patent law of that country, then Sigma-Tau
will be entitled to receive a royalty for sale of Licensed Product in that
country. In the event said sales occur, at that time the appropriate royalty
will be negotiated between Sigma Tau and SPIL or its designee in good faith and
reflect normal and customary commercial practices. Paragraph 11.3 will apply if
necessary and appropriate.
5.7 Sigma-Tau and SPIL shall perform their respective obligations
under this Article 5 using diligent efforts.
ARTICLE 6
DEVELOPMENT, MARKETING AND SALE OF PRODUCTS
6.1 (a) Development Plan. Within sixty (60) days after the
Effective Date, Sigma-Tau shall deliver to SPIL a written outline of the
activities that Sigma-Tau plans to undertake with respect to the development of
the Licensed Product. The outline shall be updated on or before December 31,
2000, March 31, 2001, June 30, 2001, September 30, 2001 and December 31, 2001
and at such other times as the parties may mutually agree.
(b) Marketing Plan. Within three (3) months before the
expected date of launch of the Licensed Product in any country in the Territory,
Sigma-Tau shall deliver to SPIL a written marketing plan detailing Sigma-Tau's,
its Affiliates' and sublicensees' plans for marketing, distributing and selling
the Licensed Product in each country in the Territory during the next twelve-
(12) month period ("Marketing Plan"). Thereafter, Sigma-Tau shall deliver
written Marketing Plans to SPIL at six (6) and twelve (12) months after the
initial launch date during the first year of this Agreement; and thereafter on a
semi-annual basis. Each such Plan shall contain a detailed plan for the
reasonable and diligent commercialization of the Licensed Product in each
country in the Territory, including (1) a product pricing strategy; and (2) a
marketing and sales strategy including anticipated pre- and post-launch sample
needs for Licensed Product. The parties shall meet and confer on the Marketing
Plan. SPIL will supply to Sigma-Tau a reasonable quantity of pre- and
post-launch samples of Licensed Product at no cost to Sigma-Tau. Each such
Marketing Plan shall also give a status report as to Sigma-Tau's success (or
lack of success) in implementing the prior year's plans. Sigma-Tau, its
Affiliates and sublicensees will actively market the Licensed Product in the
Territory in accordance with the terms of the Marketing Plan.
6.2 Best Efforts. Sigma-Tau, its Affiliates and sublicensees shall
use its reasonable best efforts (i) to obtain and maintain necessary
governmental approvals for the sale
12
13
of the Licensed Product in the Territory, as promptly as is commercially
feasible; (ii) thereafter to sell reasonable quantities of such Licensed Product
in the Territory; and (iii) to stimulate and increase interest in the Licensed
Product in the Territory.
6.3 Product Complaints. If Sigma-Tau, its Affiliates or
sublicensees becomes aware of any complaints or claims concerning the Licensed
Product by consumers or others, Sigma-Tau shall advise SPIL not later than
twenty-four (24) hours by telephone, confirmed in writing within three (3)
business days.
6.4 No Competition. Sigma-Tau, its Affiliates and sublicensees
will not sell or distribute during the term of this Agreement any product which
is the Licensed Product obtained from a third party not authorized under this
Agreement, is an analog or derivative of the Licensed Product, or contains a
fragment of the Licensed Product. At all times, this provision will be subject
to applicable European Union anti-trust laws.
6.5 Records.
(a) Sigma-Tau, its Affiliates and sublicensees will provide
SPIL with sales reports on a quarterly basis which show (i) the number of units
of each Licensed Product sold; and (ii) the payment received therefor. Such
records shall be kept in sufficient detail to permit a determination of the
royalties (if applicable) and other amounts due and payable hereunder by
Sigma-Tau, its Affiliates and sublicensees, and payment made to or credits due
Sigma-Tau, its Affiliates or sublicensees.
(b) Sigma-Tau, its Affiliates and sublicensees shall keep
regular and accurate records of Licensed Product Inventory and distribution
sufficient to track Licensed Product recalls, accountability of expiration
dates, and adverse reactions. Sigma-Tau, its Affiliates and sublicensees agrees
to maintain complete, clear and accurate records for the greater of (i) three
(3) years; or (ii) as required by applicable law.
(c) At the request of SPIL, Sigma-Tau, its Affiliates and
sublicensees shall permit SPIL and/or an auditor or Certified Public Accountant
appointed by SPIL to examine Sigma-Tau's, its Affiliates' and sublicensees'
records related to the Licensed Product during business hours and with
reasonable notice to Sigma-Tau, its Affiliates and sublicensees, as the case may
be. Such audit shall be at the expense of SPIL and will not be performed more
than once per calendar year. Any information received under this paragraph shall
be deemed Confidential Information.
ARTICLE 7
PRODUCT AUTHORIZATIONS/REGISTRATIONS
7.1 Influenza Indication - Italy. SPIL will use its reasonable
best efforts to support Sigma-Tau's application to the Italian Ministry of
Health for the Licensed Product for the Influenza Indication by permitting
Sigma-Tau to cross-reference the SciClone Italy Influenza Authorization and
filing, subject to the provisions of Section 7.4.
13
14
7.2 Hepatitis C. As soon as practicable following the successful
conclusion of the Hepatitis C Trial and the U.S. Hepatitis C Trial, but in no
event later than twelve (12) months following the completion of the observation
period in the Hepatitis C Trial, Sigma-Tau will use its reasonable best efforts
to prepare and file a marketing application with the EMEA, or alternatively with
each country of the Territory, for use of Licensed Product to treat hepatitis
C., under SPIL's trademark ZADAXIN, subject to the provisions of Sections 4.11
and 7.4.
7.3 Other Indications. Sigma-Tau shall use reasonable best efforts
to prepare and file marketing applications with the EMEA, or alternatively with
as many countries within the Territory as possible, for Other Indications under
SPIL's trademark ZADAXIN, subject to the provisions of Sections 4.11 and 7.4.
7.4 Information to SPIL. Sigma-Tau will provide SPIL with copies
of the marketing applications referenced in Sections 7.1 - 7.3 above thirty (30)
days prior to their intended submission date. SPIL will approve or disapprove
the content of such applications within fifteen (15) days after receipt thereof;
and Sigma-Tau may not file the applications until receiving SPIL's written
approval thereof which will not be unreasonably withheld. Sigma-Tau will also
inform SPIL immediately of the approval of any such marketing applications. Any
such marketing applications filed or other regulatory/governmental filings made
by Sigma-Tau for Licensed Product may be freely accessed and used by SPIL and/or
its Affiliates as necessary.
7.5 Duty to Maintain Authorizations. Sigma-Tau, its Affiliates and
sublicensees will use their reasonable best efforts to obtain and maintain the
authorizations referenced in this Article 7.
7.6 Registrations. Sigma-Tau, its Affiliates and sublicensees
agree to register this Agreement and any related sublicense agreement with any
foreign governmental agency within the Territory which requires such
registration; and Sigma-Tau, its Affiliates and sublicensees shall pay all costs
and fees in connection therewith.
7.7 Sigma-Tau, its Affiliates and sublicensees and SPIL shall
perform their respective obligations under this Article 7 using diligent
efforts.
ARTICLE 8
PATENTS
8.1 Prosecution and Maintenance. SPIL or SCLN shall have full
control over and responsibility for filing, prosecution and maintenance of (a)
the patent applications and patents contained in the Patent Rights and (b) any
future patent applications and patents relating to the Licensed Product during
the term of this Agreement.
8.2 Infringement by Third Parties. In the event Sigma-Tau, its
Affiliates or sublicensees or SPIL or its Affiliates becomes aware of any actual
or threatened infringement of any Patent Rights within the Territory, that party
shall promptly notify the other parties and the parties shall discuss the most
appropriate action to take. All parties shall use their reasonable best efforts
in cooperating with each other to terminate such infringement without
litigation. Within one hundred twenty (120) days after the date of notification
of infringement, if attempts
14
15
to xxxxx such infringement are unsuccessful, then Sigma-Tau or its Affiliates
has the right, but not the obligation, to bring such action at its own expense,
in which event SPIL shall cooperate with Sigma-Tau as reasonably requested. SPIL
or its Affiliates may, on its own initiative, join in any suit brought by
Sigma-Tau or its Affiliates under this Section 8.2. All recoveries, damages and
awards in a suit brought by Sigma-Tau or its Affiliates and not joined by SPIL,
after reimbursement of any litigation, shall be due to Sigma-Tau. In the event
that SPIL joins in any suit brought by Sigma-Tau or its Affiliates under this
Section 8.2, all recoveries, damages and awards in such joint infringement
action shall be shared equally by SPIL and Sigma-Tau. In the event that
Sigma-Tau or its Affiliates elects not to institute or prosecute any suit to
enjoin or recover damages from any infringer, then SPIL or its Affiliates alone
may, in its sole discretion and at their expense, initiate and conduct an
infringement action and keep any settlement or award which may be obtained.
Sigma-Tau and SPIL agree that neither will settle any action commenced by it in
a manner that is prejudicial to any Patent Rights without the other party's
prior written approval.
8.3 Challenge to Patent Rights. In the event a Licensed Product
becomes the subject of a claim for a patent or other proprietary right
infringement in the Territory by virtue of the incorporation of the SPIL
Technology therein, the parties shall promptly give notice to the other and meet
to consider the claim and the appropriate course of action. Sigma-Tau or its
Affiliates shall have the right to conduct the defense of any such suit brought
against Sigma-Tau or its Affiliates at their own cost, and shall have the sole
right and authority to settle any such suit, provided that SPIL shall cooperate
with Sigma-Tau or its Affiliates in connection with the defense of such claim.
If brought against SPIL or its Affiliate and Sigma-Tau and its Affiliates, then
SPIL shall have the right to join in the defense of such suit and the parties
will jointly have the right to conduct the defense of such suit and to settle
such suit, and each party shall bear its own respective costs.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 SPIL. SPIL represents and warrants:
(a) SPIL is a corporation validly formed and existing under
the laws of Cayman Islands;
(b) SPIL or its Affiliates have the right to grant to
Sigma-Tau the license rights which SPIL is granting to Sigma-Tau pursuant to the
terms of this Agreement. SPIL further represents and warrants that SPIL's
Affiliates will not challenge the validity of the license rights granted to
Sigma-Tau pursuant to the terms hereof. The parties acknowledge that such
representation shall be at all times subject to and qualified by any applicable
law, rule, regulation, ordinance, determination or requirement in connection
with the rights reserved to the Government of the United States of America
thereunder;
(c) The execution, delivery and performance of this
Agreement have been duly and effectively authorized by all necessary corporate
or other actions, that those actions do not violate, conflict with, or result in
the breach of any provision of its Articles of
15
16
Incorporation, bylaws or any comparable documents, or of any agreement to which
it is a party; and
(d) This Agreement is binding on and enforceable against
SPIL in accordance with its terms.
9.2 Warranty Disclaimer. Nothing in this Agreement may be
construed as:
(a) A warranty or representation by SPIL as to the validity
or scope of any Patent Rights or Trademark Rights; provided, however, that, to
the best of SPIL's knowledge, the Patent Rights and Trademark Rights are valid;
(b) A warranty or representation that anything made, used,
sold or otherwise disposed of under any license granted in this Agreement is or
will be free from infringement of patents, copyrights and other rights of third
parties;
(c) An obligation to bring or prosecute actions or suits
against third parties for infringement, except to the extent and in the
circumstances described in Section 8.2; and
(d) A grant by implication, estoppel, or otherwise of any
licenses under patent application or patents of SPIL or other persons except as
provided in Section 2.1 hereof.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, SPIL MAKES NO REPRESENTATION
AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING
WARRANTIES AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
9.3 Sigma-Tau. Sigma-Tau represents and warrants:
(a) It is a corporation validly formed and existing under
the laws of Italy;
(b) There are no prior or contemporaneous assignments,
grants, licenses, encumbrances, obligations or agreements, either written, oral,
express or implied, to which it is a party, that are inconsistent with this
Agreement;
(c) The execution, delivery and performance of this
Agreement have been duly and effectively authorized by all necessary corporate
or other actions, that those actions do not violate, conflict with, or result in
the breach of any provision of its Articles of Incorporation, bylaws or any
comparable documents, or of any agreement to which it is a party; and
(d) This Agreement is binding on and enforceable against
Sigma-Tau in accordance with its terms.
16
17
ARTICLE 10
TERM AND TERMINATION.
10.1 Term. This Agreement shall become effective as of the
Effective Date, and unless earlier terminated under this Article, this Agreement
shall end on the date that is the later of (i) the expiration of the last to
expire of any granted patent included in the Patent Rights in the Territory,
which patent is relevant to any Licensed Product then on the market, or twelve
(12) years from the Effective Date. This Agreement may be renewed for additional
terms of two (2) years upon mutual written agreement of the parties.
10.2 Termination for Default. This Agreement may be terminated by
a non-defaulting party, if the other party substantially fails to perform or
otherwise materially breaches any of the material terms, covenants or provisions
of this Agreement. The non-defaulting party shall give written notice of intent
to terminate to the breaching party stating the grounds therefor. The party
receiving the notice shall have sixty (60) days thereafter to correct such
breach. If such breach is not corrected within said sixty (60) day period, then
this Agreement shall automatically terminate.
10.3 Effect of Termination.
(a) Upon termination of this Agreement by SPIL under
Section 10.2:
(i) Neither party shall thereby be discharged from any
liability or obligation to the other party which became due or payable prior to
the effective date of such expiration or termination; and
(ii) Those Sections of this Agreement which by their
nature extend beyond termination, including but not limited to the
confidentiality obligations of Section 11.1, the arbitration obligations of
Section 11.3, and the indemnification obligations of Section 11.4, shall
continue; and
(iii) Sigma-Tau shall discontinue the use, marketing and
sale of Licensed Product and shall discontinue any use of the SPIL Technology
and the license granted to Sigma-Tau in Section 5.6(b) shall revert to SPIL.
(iv) All rights transferred to Sigma-Tau hereunder shall
revert to SPIL, and Sigma-Tau agrees to execute all instruments necessary and
desirable to revest said rights in SPIL. Sigma-Tau, its Affiliates and
sublicensees shall transfer all governmental filings or approvals regarding the
Licensed Product in the Territory, including, without limitation, regulatory
filings, marketing applications, clinical trial approvals, marketing
authorizations and trademark applications or registrations for the Licensed
Product to SPIL or its designee.
(v) Any royalty to Sigma-Tau that arises from Section
5.6(c) prior to the date of termination under Section 10.3 (a) will continue to
apply after the termination of this Agreement under Section 10.3 (a), for so
long as the relevant patent for the Invention or Improvement referred to in
Section 5.6 (c) is in force.
17
18
(b) Upon termination of this Agreement by Sigma-Tau
pursuant to Section 10.2:
(i) Neither party shall thereby be discharged from any
liability or obligation to the other party which became due or payable prior to
the effective date of such expiration or termination; and
(ii) Those Sections of this Agreement which by their
nature extend beyond termination, including but not limited to the
confidentiality obligations of Section 11.1, the arbitration obligations of
Section 11.3, and the indemnification obligations of Section 11.4 shall
continue; and
(iii) Any royalty to Sigma-Tau that arises from Section
5.6(c) prior to the date of termination under Section 10.3(b) will continue to
apply after the termination of this Agreement under Section 10.3 (b), for so
long as the relevant patent for the Invention or Improvement referred to in
Section 5.6(c) is in force.
(c) Upon the expiration of the term of this Agreement or
any renewal thereof under Section 10.1,
(i) Neither party shall thereby be discharged from any
liability or obligation to the other party which became due or payable prior to
the effective date of such expiration or termination; and
(ii) Those Sections of this Agreement which by their
nature extend beyond termination, including but not limited to the
confidentiality obligations of Section 11.1, the arbitration obligations of
Section 11.3, and the indemnification obligations of Section 11.4, shall
continue.
(iii) Any royalty to Sigma-Tau that arises from Section
5.6(c) prior to the date of expiration of this Agreement under Section 10.1 will
continue to apply after the expiration of this Agreement under Section 10.1, for
so long as the relevant patent for the Invention or Improvement referred to in
Section 5.6 (c) is in force.
(d) Upon either termination of this Agreement by Sigma-Tau
pursuant to Section 10.2 or expiration of the terms of this Agreement or any
renewal thereof under Section 10.1,
(i) Sigma-Tau shall continue to be entitled to use the
Trademark Rights, free of charge, in connection with Licensed Products or the
Thymosin Alpha 1, purchased from SPIL or its designee. The terms for any such
supply shall be contained in a further agreement.
(ii) If Sigma-Tau wishes to continue to use the
Trademark Rights in connection with the Licensed Products or Thymosin Alpha 1
which has not been purchased from SPIL or its designee, Sigma-Tau shall be
entitled to do so subject to the payment of a royalty to SPIL for the use of the
Trademark Rights. Said royalty shall be equal to the
18
19
following percentage of Sigma-Tau's Net Sales of Licensed Products sold in the
Territory under the Trademark Rights;
(1) [****] for the first twenty
four (24) month period from the termination or expiration of this Agreement;
(2) [****] for the second twenty
four (24) month period from the termination or expiration of this Agreement; and
(3) [****] thereafter.
ARTICLE 11
GENERAL PROVISIONS
11.1 Confidential Information. The parties agree that a party
receiving Confidential Information of the other party will maintain in
confidence such Confidential Information to the same extent such party maintains
its own proprietary information, but in any event the party shall (i) not
disclose such Confidential Information to any third party without prior written
consent of the other party and (ii) not use such Confidential Information for
any purpose except those permitted by this Agreement. Notwithstanding the
foregoing, either party may provide or disclose Confidential Information
provided by the other party (i) to the extent that disclosure is reasonably
necessary in filing or prosecuting patent applications, prosecuting or defending
litigation, complying with applicable laws or government regulations or
marketing Licensed Product, or (ii) expressly contemplated by the terms of this
Agreement.
11.2 Return of Documents. In the event that this Agreement should
terminate due to a material breach, all materials and documents which have been
exchanged between the parties shall be returned promptly to the provider, or
accounted for in the case of material consumed or provided to a third party.
11.3 Arbitration. If a dispute arises between the parties relating
to the interpretation or performance of this Agreement, the parties agree to
hold a meeting, attended by individuals with decision-making authority regarding
the dispute, to attempt in good faith to negotiate a resolution of the dispute
prior to pursuing the arbitration provided for in this Section. Such meeting
shall be held in London. If the parties cannot resolve the disputed matter
within sixty (60) days of commencing such discussions, then each party agrees to
settle the dispute before the London Court of Arbitration in accordance with the
rules set forth by that Court. The arbitration board will be formed in London,
and both parties agree to the jurisdiction of London for such arbitration. The
proceedings will be held in the English language. The arbitrator(s) shall be an
individual skilled in the legal and business aspects of the subject matter of
this Agreement, and shall be selected pursuant to the rules of the London Court
of Arbitration. Responsibility for the costs of the arbitration shall be
determined by the arbitrator. The arbitrators shall make their decisions in
accordance with applicable law and the factual evidence presented. The decision
of the arbitrators shall be final and binding upon the parties and may be sued
upon or enforced by the party in whose favor it runs in any court of competent
jurisdiction at the option of the successful party. The arbitrators will be
instructed to prepare and deliver a
*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.
19
20
written, reasoned opinion conferring their decision. Notice of such arbitration
may be served by registered mail and such will constitute good and sufficient
personal service of process for such arbitration. The rights and obligations set
forth in this Section 11.3 shall survive the expiration or termination of this
Agreement.
11.4 Indemnification and Insurance.
(a) Indemnification by SPIL. SPIL shall be liable to
Sigma-Tau for any loss or damage due to illness, injury or death related to the
Licensed Product to the extent that such loss or damage results from or is
caused by the negligence of SPIL in its performance under this Agreement. SPIL
shall defend, indemnify and hold Sigma-Tau and its agents, employees, officers,
directors and Affiliates harmless from all suits, claims, liabilities, losses,
expenses and damages (including court costs and reasonable attorneys' fees and
expenses) of any kind or character arising from such loss or damage.
(b) Indemnification by Sigma-Tau. Sigma-Tau shall be liable
(i) for any loss or damage due to personal injury, illness or death relating to
the Licensed Product to the extent that it results from a cause or causes
occurring subsequent to the delivery of any Licensed Product by SPIL to
Sigma-Tau hereunder and is caused by the negligence of Sigma-Tau or its
employees in the storage, transportation, use, handling or labeling of such
Licensed Product or the failure of Sigma-Tau or its employees to comply with the
recommendations provided by SPIL in respect of the storage, transportation, use
and handling of such Licensed Product; and (ii) for any product liability
associated with a Licensed Product sold to Sigma-Tau by SPIL (other than any
liability for which SPIL has agreed to indemnify Sigma-Tau pursuant to
Subsection 11.4(a) above). Sigma-Tau shall defend, indemnify and hold SPIL and
its agents, employees, officers, directors and Affiliates harmless from all
suits, claims, liabilities, losses, expenses and damages (including court costs
and reasonable attorneys' fees and expenses) of any kind or character arising
from such liability, loss or damage.
(c) Product Liability Insurance. Not later than the date of
first use of a Licensed Product in humans in any country in the Territory, each
party hereto shall obtain and maintain during the term of this Agreement product
liability insurance in the amount of Five Million United States Dollars (US
$5,000,000) or the Euro equivalent, issued by a reputable insurance company
reasonably acceptable to the other party, insuring each such party's respective
liability and indemnification obligations set forth in Subsections 11.4(a) and
(b) above, respectively. Each such insurance policy shall name the other party
as an additional insured party, shall provide for sixty (60) days written notice
to such additional named insured party prior to any cancellation of, or any
material change in, coverage, and shall provide that in the event of proposed
cancellation for nonpayment of premium, such additional named insured party
shall have the right to continue coverage by payment of the required premium.
Each party shall provide to the other party a certificate of insurance issued by
the relevant insurance company verifying the issuance of an insurance policy
complying with the provisions of this Subsection 11.4 (c).
(d) Agreement to Cooperate. In all actions, claims and
proceedings of the kind described in Subsections 11.4(a) and (b) above, each of
the parties will at its own cost render to the other party all assistance,
furnish all documents and cooperate to the fullest extent
20
21
of its capacity, including but not limited to the assistance of, and the right
to consult with, such party's technical and scientific personnel and attorneys.
(e) Indemnification for Breach of Representations and
Warranties. SPIL shall defend, indemnify and hold harmless Sigma-Tau and its
agents, employees, officers, directors and Affiliates from and against any and
all losses or damages caused by a breach of any of the warranties and
representations set forth in Section 9.1 hereof. Sigma-Tau shall defend,
indemnify and hold harmless SPIL and its agents, employees, officers, directors
and Affiliates from and against any and all losses or damages caused by a breach
of any of the warranties and representations set forth in Section 9.3 hereof.
11.5 Assignability. This Agreement shall be binding upon and shall
inure to the benefits of the parties and their permitted successors and assigns,
but shall not be transferable or assignable by Sigma-Tau without the prior
written consent of SPIL, which consent may be withheld at the discretion of
SPIL, except that such consent shall not be unreasonably withheld in the case of
transfer or assignment by Sigma-Tau to an Affiliate.
11.6 Currency. All payments under this Agreement shall be made in
United States dollars or in such other currency including the Euro, as the
parties may mutually agree.
11.7 Severability. If, and insofar as, any part or provision of
this Agreement is or becomes void or unenforceable, it shall be deemed not to be
a part of this Agreement, and the remaining provisions of this Agreement shall
continue in full force and effect. The parties shall meet to discuss the void
and unenforceable provisions and shall substitute therefor lawful and
enforceable provisions which so far as possible result in the same economic
effect.
11.8 Notices. Any notice or communication required to be given
hereunder shall be deemed to have been duly given (1) upon actual delivery if
delivered by personal service at the address first written above, or such other
address as a party shall have notified the other party in writing as its address
for service, or (2) upon actual receipt, or twenty-four (24) hours after being
sent, whichever is earlier, of facsimile transmission if sent to the facsimile
number indicated below, or such other facsimile number as a party shall have
notified the other party in writing as its number for service:
All notices to Sigma-Tau shall be communicated to:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Xxx Xxxxxxx Xx, 00,000
00000 Xxxxxxx Xxxx
Xxxxx
Attention: Vice President
Telefax: 011-39-06-91393980
Phone: 000-00-00-00000000
21
22
With a copy to:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Legal Department
Xxx Xxxxxxx Xx, 00,000
00000 Xxxxxxx Xxxx
Xxxxx
Telefax: 011-39-06-91394235
Phone: 000-00-00-00000000
All notices to SPIL shall be communicated to:
SciClone Pharmaceuticals International Ltd.
c/o SciClone Pharmaceuticals, Inc.
000 Xxxxxxx'x Xxxxxx Xxxx.
Xxx Xxxxx, XX 00000
XXX
Attention: Xxxxxx X. Xxxxxxx, Managing Director
Telefax: (000) 000-0000
Phone: (000) 000-0000
with a copy to:
Xxxx Xxxx Xxxx & Freidenrich
0000 Xxxxxxxxx Xx., Xxx. 0000
Xxx Xxxxx, XX 00000
XXX
Attention: X. Xxxx Xxxx, Esq.
Telefax: (000) 000-0000
Phone: (000) 000-0000
11.9 Waiver. Any waiver by either party of the breach of any term
or condition of this Agreement will not be considered as a waiver of any
subsequent breach of the same or any other term or condition hereof. Any waiver
must be in writing.
11.10 Further Actions. Each party hereto agrees to execute such
further papers or agreements as may be necessary to effect the purpose of this
Agreement and carry out its provisions.
11.11 Entire Agreement. This Agreement constitutes and contains
the entire Agreement of the parties and supersedes any and all prior
negotiations, correspondence, understandings and agreements between the parties
respecting the subject matter hereof with the following exception. For avoidance
of doubt, the parties acknowledge and agree that this Agreement does not
supersede the February 26, 1998 letter agreement between SCLN and Sigma-Tau.
11.12 Captions. The captions to this Agreement are for convenience
only, and are to be of no force or effect in construing or interpreting the
provisions of this Agreement.
22
23
11.13 Interpreting Law. This Agreement shall be governed by and
interpreted in accordance with the laws of the State of Delaware, U.S.A.,
without giving effect to choice of law principles.
11.14 Publicity and Use of Name. Neither party shall make
reference to the specific terms of this Agreement in any press release or other
public statement without prior consultation and approval of the other party,
which may be oral, except for such disclosures as may be required by applicable
law; provided, that the party making such press release or public statement, to
the extent possible, shall provide the other party with advance notice and shall
consult with that party regarding such press release or public statement, and,
in any event, shall provide the other party with simultaneous notice of any such
press release or public statement.
11.15 Force Majeure. Except where otherwise expressly provided in
this Agreement, neither party shall be considered in default in the performance
of its representations, warranties or obligations hereunder if the accuracy or
performance is prevented, restricted or interfered with because of any event of
Force Majeure. The party so affected shall give notice promptly to the other
party in writing of the event of Force Majeure, and, thereupon, the affected
party shall be excused from those of its obligations hereunder which it is
unable to perform because of that event of Force Majeure for as long as that
event of Force Majeure shall remain in force plus a period of thirty (30) days.
11.16 Counterparts. This Agreement may be signed in multiple
counterparts. Signatures may be transmitted by facsimile telecopier.
11.17 NO CONSEQUENTIAL DAMAGES. NEITHER SIGMA-TAU OR ITS
AFFILIATES NOR SPIL OR ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY FOR ANY
INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS
AGREEMENT OR TERMINATION OF THIS AGREEMENT, WHETHER FOR BREACH OR WARRANTY OR
ANY OBLIGATION ARISING THEREFROM OR OTHERWISE, WHETHER LIABILITY IS ASSERTED TO
BE STATUTORY, IN CONTRACT OR TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT
LIABILITY), AND IRRESPECTIVE OF WHETHER A PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF ANY SUCH LOSS OR DAMAGE.
11.18 Independence of Parties. SPIL and Sigma-Tau are independent
contractors and neither party is the legal representative, agent, joint
venturer, partner, or employee of the other party for any purpose whatsoever.
Neither party has any right or authority to assume or create any obligation of
any kind or to make any representation or warranty on behalf of the other party,
whether express or implied, or to bind the other party in any respect
whatsoever, except as expressly agreed to herein.
11.19 Attorney's Fees. In the event of a dispute between the
parties hereto or in the event of any default or arbitration or other legal
action hereunder, the prevailing party shall be entitled to recover from the
non-prevailing party its reasonable attorneys' fees and other costs incurred in
connection therewith.
23
24
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed effective as of the date first written above.
SCICLONE PHARMACEUTICALS SIGMA-TAU INDUSTRIE
INTERNATIONAL LTD. FARMACEUTICHE RIUNITE, S.P.A.
By: By:
--------------------------------- ---------------------------------
Xxxxxx X. Xxxxxxx, M.D.
Title: Director Title: Vice-President and
Chief Operating Officer
24
25
EXHIBIT A
Licensed Patent Applications and Patents
Austria
[****]
*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.
25
26
Licensed Patent Applications and Patents
Belgium
[****]
*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.
26
27
Licensed Patent Applications and Patents
Denmark
[****]
*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.
27
28
Licensed Patent Applications and Patents
Finland
[****]
*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.
28
29
Licensed Patent Applications and Patents
France
[****]
*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.
29
30
Licensed Patent Applications and Patents
Germany
[****]
*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.
30
31
Licensed Patent Applications and Patents
Greece
[****]
*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.
31
32
Licensed Patent Applications and Patents
Ireland
[****]
*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.
32
33
Licensed Patent Applications and Patents
Italy
[****]
*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.
33
34
Licensed Patent Applications and Patents
Luxembourg
[****]
*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.
34
35
Licensed Patent Applications and Patents
Netherlands
[****]
*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.
35
36
Licensed Patent Applications and Patents
Norway
[****]
*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.
36
37
Licensed Patent Applications and Patents
Portugal
[****]
*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.
37
38
Licensed Patent Applications and Patents
Spain
[****]
*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.
38
39
Licensed Patent Applications and Patents
Sweden
[****]
*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.
39
40
Licensed Patent Applications and Patents
Switzerland
[****]
*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.
40
41
Licensed Patent Applications and Patents
United Kingdom
[****]
*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.
41
42
EXHIBIT B
FINISHED PRODUCT SPECIFICATIONS
--------------------------------------------------------------------------------
CODE NO.: [****] REVISION: [****] 1.
--------------------------------------------------------------------------------
MATERIAL NAME: ZADAXIN(R) (THYMOSIN ALPHA 1), INJECTION
--------------------------------------------------------------------------------
EFFECTIVE DATE: SUPERSEDES: [****]
--------------------------------------------------------------------------------
----------------------------------------------------------------------------------------
TEST METHOD SPECIFICATION
----------------------------------------------------------------------------------------
Identity by HPLC [****] [****]
----------------------------------------------------------------------------------------
Potency by HPLC [****] [****]
----------------------------------------------------------------------------------------
Related Substances [****] [****]
by HPLC
----------------------------------------------------------------------------------------
Moisture Content [****] [****]
----------------------------------------------------------------------------------------
Pyrogen [****] [****]
----------------------------------------------------------------------------------------
Sterility [****] [****]
----------------------------------------------------------------------------------------
pH [****] [****]
----------------------------------------------------------------------------------------
Uniformity of Dosage [****] [****]
----------------------------------------------------------------------------------------
Appearance [****] [****]
----------------------------------------------------------------------------------------
Appearance on [****] [****]
Reconstitution
----------------------------------------------------------------------------------------
APPROVALS
------------------------------------------------------ -------------------
REGULATORY AFFAIRS DATE
------------------------------------------------------ -------------------
CLINICAL DATE
------------------------------------------------------ -------------------
MANUFACTURING DATE
------------------------------------------------------ -------------------
QUALITY ASSURANCE DATE
------------------------------------------------------ -------------------
OPERATIONS DATE
*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.
42
43
EXHIBIT C
Licensed Trademarks
[****]
*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.
43
44
EXHIBIT D
[SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. LETTERHEAD]
February 26, 1998
SciClone Pharmaceuticals Inc.
000 Xxxxxxx'x Xxxxxx Xxxx.
Xxx Xxxxx
Xxxxxxxxxx 00000
XXX
Dear Sirs,
RE: THYMOSIN ALPHA 1
This letter is a follow-up of the discussions held between you ("SciClone") and
us ("Sigma-Tau") regarding the product Thymosin Alpha 1 (hereinafter "Product").
Sigma-Tau is the holder of a health registration (so called "Autorizzazione
all'Immissione in Commercio") of the Product in Italy. Such health registration
has been obtained by Sigma-Tau through grant of rights from Sclavo SpA. SciClone
is now under negotiations with Sclavo SpA for the acquisition of the rights
relating to Product in Italy.
Sigma-Tau requires further information regarding the Product in order to renew
such health registration with the Italian Ministry of Health in Italy.
Following execution of this letter, SciClone shall, in good faith, attempt to
have Sclavo SpA disclose to Sigma-Tau all information necessary and sufficient
to renew and maintain the health registration of the Product (hereinafter
"Information") in Italy.
The Information shall be used by Sigma-Tau solely for the purpose of filing it
with the Italian Ministry of Health in order to renew and maintain the health
registration of the Product in the name of Sigma-Tau and for no other purpose
whatsoever. Further, Sigma-Tau undertakes not to use the health registration so
renewed for any purpose until an agreement between Sigma-Tau and SciClone for
the distribution in Italy of the Product has been executed, provided that
SciClone acquires the rights on the Product in Italy.
Save for disclosure to the Italian Ministry of Health as provided for in this
letter, Sigma-Tau shall ensure that the Information is not disclosed to any
third party without the prior written consent of SciClone for a period of ten
(10) years from receiving of such Information, unless such provision is
superseded by further agreements executed between the parties hereof. This
undertaking shall not apply to any part of the Information which:
(a) become generally available to the public other than as a result of
disclosure by Sigma-Tau or any party to whom Sigma-Tau has disclosed such
Information to; or
44
45
(b) Sigma-Tau can demonstrate was in its possession at the time of disclosure
to it by SciClone and which Sigma-Tau lawfully acquired other than from
SciClone or anyone acting on its behalf; or
(c) was lawfully acquired on a non-confidential basis from others who are not
prohibited from disclosing such Information by an obligation to SciClone;
or
(d) was disclosed with the prior approval of SciClone.
Notwithstanding anything in this letter to the contrary, it does not in any way
constitute an obligation or undertaking by Sigma-Tau or by SciClone to enter
into any agreement relating to the distribution in Italy of the Product or
otherwise.
If the foregoing is acceptable to you, will you please sign the attached copy of
this letter and return said signed copy to us.
Yours faithfully,
Sigma-Tau Industrie Farmaceutiche Riunite SpA
SciClone Pharmaceuticals, Inc.
45
