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Title: |
Manufacturing Services Agreement |
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Date: |
2001 |
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Preview shows 19KB of 60KB total |
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$44 |
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ID: |
#326662 |
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MANUFACTURING SERVICES AGREEMENT
BY AND BETWEEN
SCICLONE PHARMACEUTICALS INTERNATIONAL LTD.
AND
ISF S.P.A.
{PAGE} 2
CONFIDENTIAL TREATMENT--EDITED COPY
TABLE OF CONTENTS
{TABLE}
Page
----
{S} {C}
RECITALS................................................................................ 1
ARTICLE I DEFINITIONS.................................................................. 1
1.1 "Acceptance Period"......................................................... 1
1.2 "Affiliate"................................................................. 1
1.3 "Ampoule"................................................................... 1
1.4 "Customer".................................................................. 2
1.5 "Delivery Date"............................................................. 2
1.6 "Excipient"................................................................. 2
1.7 "Facility".................................................................. 2
1.8 "FDA"....................................................................... 2
1.9 "Finished Product".......................................................... 2
1.10 "Manufacturer"............................................................. 2
1.11 "Methods".................................................................. 2
1.12 "Processing"............................................................... 2
1.13 "Specifications"........................................................... 2
1.14 "TA 1 Bulk Specifications"................................................. 2
1.15 "Thymosin Alpha 1" or "TA-1"............................................... 2
ARTICLE II FORECAST, PURCHASE AND SUPPLY............................................... 3
2.1 Purchase and Supply......................................................... 3
2.2 Forecasts................................................................... 3
2.3 Orders...................................................................... 3
2.4 Amendment to Purchase Orders................................................ 3
ARTICLE III SUPPLY AND PROCESSING OF MATERIALS.......................................... 3
3.1 Supply of Materials......................................................... 3
3.2 Testing of TA-1............................................................. 4
3.3 Processing of Materials..................................................... 4
3.4 Product Specifications; Testing............................................. 5
3.5 FDA and Regulatory Support.................................................. 5
3.6 cGMP Compliance and QA Audits............................................... 6
3.7 Import / Export............................................................. 6
3.8 Rights to Manufacturing Processes Improvements.............................. 6
3.9 Approval for Change in Manufacturing Process................................ 7
3.10 Compliance with Laws....................................................... 7
3.11 Documentation.............................................................. 7
3.12 Rework..................................................................... 7
3.13 Samples.................................................................... 7
3.14 Storage and Handling....................................................... 7
{/TABLE}
{PAGE} 3
CONFIDENTIAL TREATMENT--EDITED COPY
{TABLE}
{S} {C}
3.15 Labels, Packaging and Shipping............................................. 7
ARTICLE IV PRICES AND PAYMENT.......................................................... 8
4.1 Price....................................................................... 8
4.2 Reimbursement............................................................... 8
4.3 Payment..................................................................... 8
ARTICLE V DELIVERY AND ACCEPTANCE....................................................... 9
5.1 Batch Records and Certificates of Analysis.................................. 9
5.2 Delivery.................................................................... 9
5.3 Acceptance and Disposition of Finished Product.............................. 9
5.4 Replacement Batch........................................................... 10
ARTICLE VI REPRESENTATIONS AND WARRANTIES.............................................. 10
6.1 Existence and Power......................................................... 10
6.2 Authorization and Enforcement of Obligations................................ 11
6.3 No Consents................................................................. 11
6.4 No Conflict................................................................. 11
6.5 Limited Warranty............................................................ 11
6.6 Remedy...................................................................... 11
ARTICLE VII INDEMNIFICATION............................................................ 12
7.1 Indemnity................................................................... 12
7.2 Expenses.................................................................... 12
ARTICLE VIII PROPRIETARY INFORMATION................................................... 13
8.1 Obligation.................................................................. 13
8.2 Definition.................................................................. 13
8.3 Exclusions.................................................................. 13
8.4 Additional Restrictions..................................................... 13
ARTICLE IX TERM; TERMINATION........................................................... 14
9.1 Term........................................................................ 14
9.2 Surviving Obligations....................................................... 14
9.3 Termination................................................................. 14
ARTICLE X ARBITRATION.................................................................. 14
10.1 Binding Arbitration........................................................ 14
10.2 Arbitration Location....................................................... 14
10.3 Language of Arbitration.................................................... 15
10.4 Governing Law.............................................................. 15
10.5 Award Enforcement.......................................................... 15
10.6 Costs...................................................................... 15
{/TABLE}
-ii-
{PAGE} 4
{TABLE}
{S} {C}
ARTICLE XI MISCELLANEOUS............................................................... 15
11.1 Use of Name................................................................ 15
11.2 Recall..................................................................... 15
11.3 Independent Parties........................................................ 15
11.4 English Language........................................................... 15
11.5 Notice..................................................................... 15
11.6 Severability............................................................... 16
11.7 Waiver..................................................................... 16
11.8 Entire Agreement........................................................... 16
11.9 Nonassignability; Binding on Successors.................................... 16
11.10 Force Majeure............................................................. 16
11.11 Publicity................................................................. 16
11.12 Counterparts.............................................................. 16
11.13 Captions.................................................................. 17
11.14 Reference to Manufacturer................................................. 17
{/TABLE}
EXHIBITS:
A Specifications
B Methods
C Bulk Specifications
D Processing Fee
-iii-
{PAGE} 5
CONFIDENTIAL TREATMENT--EDITED COPY
MANUFACTURING SERVICES AGREEMENT
THIS AGREEMENT (the "Agreement") is made and effective as of the 20th
day of April, 1998 by and between SciClone Pharmaceuticals International, Ltd.,
a corporation organized under the laws of the Cayman Islands ("Customer"),
having its principal place of business at Room 3705, Windsor House, 311
Gloucester Road, Causeway Bay, Hong Kong, and ISF S.p.A., a corporation
organized under the laws of Italy ("Manufacturer"), having its principal place
of business at Via Tiburtina 1040,00156 Rome, Italy (together the "Parties" or
individually, a "Party").
RECITALS
A. Customer intends to sell products containing Thymosin Alpha 1, or
TA-1 (as defined below) under the necessary registrations and permits.
B. Manufacturer has at its disposal, facilities and suitably trained
personnel to manufacture a pharmaceutical product containing TA-1 on behalf of
Customer, and Manufacturer owns or has access to the relevant know-how.
C. Customer has requested Manufacturer to carry out such manufacturing
on the conditions and terms specified herein and to supply Customer with the
resultant product.
D. Manufacturer is willing to supply Customer with the manufactured
products containing TA-1.
NOW, THEREFORE, in consideration of the foregoing premises, which are
incorporated into and made a part of this Agreement, and of the mutual covenants
which are set forth herein, the Parties hereby agree as follows:
ARTICLE I
DEFINITIONS
1.1 "Acceptance Period" shall have the meaning as set forth in Section
5.3(b).
1.2 "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).
1.3 "Ampoule" shall mean an ampoule of water to be used for
reconstitution of TA-1 contained in an associated Vial set forth in the
Specifications in Exhibit A.
{PAGE} 6
CONFIDENTIAL TREATMENT--EDITED COPY
1.4 "Customer" shall mean SciClone Pharmaceuticals International, Ltd.,
as identified above, and its Affiliates.
1.5 "Delivery Date" shall mean the date set forth in the relevant
purchase order on which Manufacturer must supply Customer with Finished Product.
1.6 "Excipient" shall mean all raw materials other than TA-1 as defined
in the Specifications set forth in Exhibit A as a constituent part of a
completed Vial or Ampoule.
1.7 "Facility" shall mean Manufacturer's manufacturing facility located
at Via Tiburtina 1040,00156 Rome, Italy or any other manufacturing facility
operated by Manufacturer.
1.8 "FDA" means the United States Food and Drug Administration.
1.9 "Finished Product" shall mean TA-1 processed in accordance with the
Specifications for stability and clinical purposes, and packaged in a Vial, for
pre-clinical, clinical, commercial and distribution purposes.
1.10 "Manufacturer" shall mean ISF S.p.A., as identified above, and its
Affiliates.
1.11 "Methods" shall mean the analytical protocol utilized to determine
physical, chemical or microbiological attributes of a bulk or finished product
as set forth in Exhibit B.
1.12 "Processing" shall mean formulating, filling, lyophilizing,
inspecting and labeling TA-1 in Vials according to the Specifications; or
filling, inspecting and labeling Ampoules; or packaging Finished Product and
conducting associated inspections.
1.13 "Specifications" shall mean the procedures, test results,
requirements, standards and other data and shall include the services, as all of
the foregoing are set forth herein or attached hereto and made a part hereof as
Exhibit A, as such Exhibit may be revised from time to time upon written mutual
agreement of the Parties, with any modifications resulting in changes in
Manufacturer's cost being subject to price increases or decreases acceptable to
both Parties. The Specifications shall include the Finished Product, Excipient,
Vial and Ampoule Specifications.
1.14 "TA-1 Bulk Specifications" shall mean the specifications for bulk
TA-1 set forth on Exhibit C hereto.
1.15 "Thymosin Alpha 1" or "TA-1" shall mean the compound further
described in Exhibit C hereto.
2
{PAGE} 7
CONFIDENTIAL TREATMENT--EDITED COPY
ARTICLE II
FORECAST, PURCHASE AND SUPPLY
2.1 Purchase and Supply. During the term of this Agreement, Customer
shall purchase and Manufacturer shall supply such quantities of Finished Product
as may be set forth on purchase orders placed by Customer and accepted by
Manufacturer under this Agreement.
2.2 Forecasts.
(a) On or before the first day of each calendar quarter of each
year during the term of this Agreement, Customer shall provide Manufacturer with
a written twelve (12) month rolling forecast of the quantities of Finished
Product which Customer expects to purchase during each of the next twelve (12)
months. The first quarter of such rolling forecast shall be binding upon
Customer; the following three quarters of such rolling forecast shall be deemed
nonbinding estimates. Further, months 1, 2 and 3 of the first quarter will
indicate good faith estimates of the quantities of Finished Product and Ampoules
needed to be supplied.
(b) Within fifteen (15) days after receipt of Customer's
forecasts, Manufacturer will provide Customer with a statement of its ability
and commitment to supply the quantities stated in the twelve (12) month
forecast.
2.3 Orders. During the term of this Agreement, Customer shall provide
Manufacturer with a quarterly firm purchase order setting forth (i) the
quantities ordered for delivery and the specified Delivery Date and (ii) the lot
numbers to be applied to such Vials and Ampoules. Customer shall place its
purchase orders no later than 45 days prior to the requested Delivery Date.
[****]. Any changes to the stated lot sizes of Vials and Ampoules shall be by
mutual written agreement of Customer and Manufacturer.
2.4 Amendment to Purchase Orders. Manufacturer will use reasonable
commercial efforts to accommodate a request to amend a purchase order to (i)
increase or decrease the number of Vials and/or associated Ampoules to be
Processed; or (ii) change the Delivery Date(s).
ARTICLE III
SUPPLY AND PROCESSING OF MATERIALS
3.1 Supply of Materials.
(a) Customer, at its expense, shall deliver or cause to be
delivered sufficient TA-1 to the Facility to manufacture the forecasted number
of Vials, at least thirty (30) days prior to the start of manufacture. The
quantity of bulk TA-1 delivered shall be 1.6 mg TA-1 per Vial.
(b) Manufacturer will be responsible for proper storage and
handling, as described in the TA-1 Bulk Specifications set forth in Exhibit C,
once Manufacturer receives the TA-1 from Customer or Customer's agent.
3
{PAGE} 8
CONFIDENTIAL TREATMENT--EDITED COPY
(c) In the event that any bulk TA-1 does not meet the TA-1 Bulk
Specifications after testing in accordance with Section 3.2 below, Customer
shall deliver replacement TA-1 to Manufacturer at no cost to Manufacturer.
(d) After Customer and Manufacturer have determined the TA-1
meets TA-1 Bulk Specifications pursuant to Section 3.2 below, Manufacturer shall
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