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EXHIBIT 10.2
CONFIDENTIAL TREATMENT--EDITED COPY
MATERIALS TRANSFER AGREEMENT
This Agreement, made as of December 21, 2000, is by and between SciClone
Pharmaceuticals, Inc. ("SciClone"), having a principal place of business at 901
Mariners Island Boulevard, Suite 205, San Mateo, California, USA, 94404, and F.
Hoffmann-La Roche Ltd. having a place of business at Grenzacherstrasse 124,
CH-4070 Basel, Switzerland ("Roche").
In order that SciClone may conduct two clinical studies as the Sponsor using the
investigational compound [****], SciClone and Roche (collectively the "Parties")
agree as follows:
1. Statement of Work
SciClone wishes to conduct the clinical Study No. T(alpha)1-CHC-2K0803a
dated December 22nd and clinical Study No. T(alpha)1-CHC-2K0804 dated December
22nd as the Sponsor using a combination of [****] and SciClone's product
thymosin alpha 1 for the indication of chronic hepatitis C (hereinafter
"Studies").
2. Adverse event reporting
SciClone as the Sponsor is responsible for Adverse Event Reporting. The
handling of the Serious Adverse Event Reporting is specified in Appendix 1.
3. Commencement and Termination
a. This Agreement begins on the date above and shall continue in force
until the completion of the Studies; [****].
b. The provisions of Articles, 5, 6, 7, 8 and 9 shall survive the
expiration or termination of this Agreement.
4. Supply and Use of [****]
a. Roche agrees to supply to SciClone free samples of [****] for
SciClone to conduct the clinical Study No. T(alpha)1-CHC-2K0803a and clinical
Study No. T(alpha)1-CHC-2K0804 [****] provided that:
(i) The protocols approved by Roche are used;
(ii) Roche is kept informed by SciClone of the results of the Studies;
and
(iii) Roche and it's affiliates has the unrestricted right to use any
data and results generated from such Studies without any
obligation whatsoever to SciClone.
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MATERIALS TRANSFER AGREEMENT
b. SciClone agrees to store [****] samples supplied by Roche in a
locked, secured area, in accordance with the storage requirements
provided to SciClone by Roche.
c. In practice, drug supply by Roche will commence after written
agreement between the logistics departments of both parties on
the exact amounts of [****] needed, on the procedures to be used
for labeling, Quality Control and testing and on the time
schedules for staggered [****] supply.
d. Upon the expiration or termination of this Agreement, SciClone
agrees at the request of Roche to promptly return all remaining
samples of [****].
5. Confidentiality
a. Roche and SciClone agree to hold in confidence any Information
provided by either party or obtained in the course of a Study. ("Such
Information"). [****].
b. For a period of [****] after termination or expiration of this
Agreement, Roche and SciClone shall treat as confidential all Roche and SciClone
Information received or developed pursuant to any provision of this Agreement.
6. Intellectual Property and Patents
[****]
7. Use of Data and Reprints
a. Roche may, consistent with U.S. copyright laws, use, refer to,
and disseminate reprints of scientific, medical and other published articles and
materials from journals, conferences and/or symposia relating to a Study which
disclose the name of SciClone, provided such use does not constitute an
endorsement of any commercial product or service by SciClone.
[****]
8. Publications
[****]
9. Indemnification
[****]
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MATERIALS TRANSFER AGREEMENT
10. Complete Agreement; Modification
The parties agree to the full and complete performance of the mutual
covenants contained in this Agreement. This Agreement constitutes the sole, full
and complete Agreement by and between the parties. No amendments, changes,
additions, deletions or modifications to or of this Agreement shall be valid
unless reduced to writing, signed by the parties and attached hereto.
11. Invalid Provision or Gaps
If single provisions of this Agreement are or become invalid or if there
is a gap in the Agreement, the validity of the other provisions shall not be
affected. In lieu of the invalid provision or in order to eliminate the gap, a
reasonable provision shall be made effective to carry out as nearly as
practicable the original intention of the entire Agreement.
12. Governing Law and Jurisdiction
The validity, construction and performance of this Agreement will be
governed by and construed for all purposes in accordance with the laws of
Switzerland and the jurisdiction lies in the competent Courts of Basel-City.
In witness whereof, the respective representatives of the parties have executed
this Agreement as of the day and year shown on the first page.
F. Hoffmann-La Roche Ltd
- -----------------------------------
Signature
- -----------------------------------
Name
- -----------------------------------
Title
- -----------------------------------
Signature
- -----------------------------------
Name
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CONFIDENTIAL TREATMENT--EDITED COPY
MATERIALS TRANSFER AGREEMENT
Title
SciClone Pharmaceuticals, Inc.
- -----------------------------------
Signature
Alfred Rudolph
- -----------------------------------
Name
Chief Operating Officer
- -----------------------------------
Title
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MATERIALS TRANSFER AGREEMENT
APPENDIX 1: HANDLING OF SERIOUS ADVERSE EVENTS
SCOPE
Roche and SciClone wish to set forth herein their agreements with respect to the
handling of Serious Adverse Event (SAE) reporting for the conduct of the studies
T(alpha)1-CHC-2K0803a and T(alpha)1-CHC-2K0804 with Roche's product [****] and
SciClone's product thymosin alpha 1.
DEFINITIONS
The following definitions apply to this agreement.
1.1 ADVERSE EVENT OR EXPERIENCE (AE)
Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product, which does not necessarily have to have a
causal relationship with this treatment. An AE can therefore be any unfavorable
and unintended sign (including an abnormal laboratory finding), symptom or
disease temporally associated with the use of a medicinal (investigational)
product, whether or not considered related to the medicinal (investigational)
product.
1.2 ADVERSE DRUG REACTION (ADR)
All noxious and unintended responses to a medicinal product related to any dose.
Note: The phrase "responses to a medicinal product" means that a causal
relationship between a medicinal product and an AE is at least a reasonable
possibility i.e., the relationship cannot be ruled out (based on the available
medical information at the time).
1.3 SERIOUS AE OR ADR
Any untoward medical occurrence that at any dose:
- results in death
- is life-threatening
- requires inpatient hospitalization or prolongation of existing
hospitalization
- results in persistent or significant disability/incapacity
- is a congenital anomaly/birth defect
The term "life-threatening" refers to an event in which the patient was
at risk of death at the time of the event, and it does not refer to an
event, which hypothetically might have caused death, if it were more
severe.
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Medical and scientific judgment should be exercised in deciding whether
expedited reporting is appropriate in other situations, such as important
medical events that may not be immediately life-threatening or result in death
or hospitalization but may jeopardize the patient or may require intervention to
prevent one of the outcomes listed in the definition above. These should also
usually be considered serious. Examples of such events are intensive treatment
in an emergency room or at home for [****] that do not result in
hospitalization; or [****].
1.4 NON-SERIOUS AE OR ADR
A non-serious AE or ADR refers to an untoward medical occurrence that does not
meet any of the "serious" criteria described above.
1.5 LABELED (EXPECTED) ADR
An ADR the nature and severity of which are consistent with the applicable
product information (e.g., Investigator's Brochure for an unapproved
investigational product or package insert/summary of product characteristics for
an approved product).
1.6 UNLABELLED (UNEXPECTED) ADR
ADR, the nature or severity of which is not consistent with the applicable
product information (e.g., Investigator's Brochure for an unapproved
investigational product or package insert/summary of product characteristics for
an approved product).
1.7 RECEIPT DATE
The receipt date is the calendar date when a company employee of SciClone first
receives notification of an AE, ADR or report that contains at least the five
minimum data elements (i.e., an identifiable patient, an identifiable reporter,
a suspect product, a causality, and an AE, ADR or fatal outcome) or the calendar
date when additional information to an already obtained AE or ADR report is
first received by a company employee of SciClone.
RESPONSIBILITIES
1.8 DOCUMENTATION
[****].
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MATERIALS TRANSFER AGREEMENT
1.9 COLLECTION AND PROCESSING OF SERIOUS ADVERSE EVENT REPORTS
SciClone will receive and process all SAE reports originating from the trial.
SciClone will be responsible for requesting follow-up information from
investigators if needed, in a timely manner. Follow-up information will be
transmitted to Roche as described below.
1.10 SAFETY DATA EXCHANGE FROM SCICLONE TO ROCHE
[****]. Timelines will be as follows:
- FATAL AND LIFE-THREATENING related SAE reports will be sent within 7
calendar days of receipt date
- ALL OTHER SAE REPORTS will be sent within 12 calendar days of
receipt date.
- PREGNANCY REPORTS (unless associated with a serious Adverse Event)
will be sent monthly.
[****].
1.11 REGULATORY REPORTING
SciClone and Roche will be independently responsible for determining local
reportability and for submission of regulatory reports associated with their
respective products in their respective territories in compliance with local
regulations.
1.12 ADDITIONAL SAFETY INFORMATION
SciClone will be responsible for providing the study investigators with any
additional safety data e.g. IB updates, dear Dr/Investigator letters related to
either thymosin alpha 1 or [****] which arises during the course of the study.
1.13 RANDOMIZATION CODES
[****].
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CONFIDENTIAL TREATMENT--EDITED COPY
MATERIALS TRANSFER AGREEMENT
SCICLONE AND ROCHE CONTACTS
All transfer of safety information will be made through the following designated
or alternate contact person at each company.
SCICLONE CONTACTS ROCHE CONTACTS
- ----------------- --------------
AE REPORTING/ FOLLOW-UP INFORMATION AE REPORTING/MEDWATCH FORMS (SEND VIA FAX)
Name: [****]
Title: PDBP-P
Address: Roche Products, Ltd.
Tel: 40 Broadwater Road - Building 54
Fax: Welwyn Garden City, HERTS AL7 3AY
E-mail: United Kingdom
[****]
INTERNATIONAL MEDICAL MANAGER
[****]
F. Hoffmann-La Roche AG
Grenzacherstrasse 124
Bldg 74, 4W307
CH-4070 Basel
[****]
POLICY ISSUES SAFETY QUERIES/LABELING ISSUES
[****]
Hoffmann-La Roche Inc.
340 Kingsland Street
115/439
Nutley, N.J. 07110-1199
[****]
GENERAL PHARMACOVIGILANCE LICENSING ISSUES
[****]
Roche Global Development
3401 Hillview Avenue
Palo Alto, CA 94303
USA
[****]
COMMON LANGUAGE
English will be used as a common language for exchange of safety information
between SciClone and Roche.
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MATERIALS TRANSFER AGREEMENT
RECORDS
Both Roche and SciClone will maintain reports and all related documentation (or
true copies of these documents) for a time period required by the applicable
laws and regulations in the territories for which they are responsible.
CONFIDENTIALITY
Each company agrees that all information provided by the other party will be
treated as confidential.
The companies may quote the above-mentioned information to respond to medical
queries from health professionals and regulatory authorities.
REVISIONS TO AGREEMENT
The Parties agree to revise this Agreement as necessary to comply with new or
amended legal or regulatory requirements.
This agreement shall enter into force upon signature by the parties and remain
effective until completion of the trial.
This agreement may be amended or voided if business relationships between Roche
and SciClone change; and/or safety reporting regulations change; and/or if the
information technology environment between Roche and SciClone changes; and/or if
the scope of global safety reporting requirements changes.
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