EXHIBIT 10.26
MANUFACTURING AND SUPPLY AGREEMENT
PATHEON ITALIA S.P.A.
&
SCICLONE PHARMACEUTICALS INTERNATIONAL LTD.
November 1, 2002
TABLE OF CONTENTS
ARTICLE 1
INTERPRETATION
1.1 Definitions............................................................ 1
1.2 [****]................................................................. 5
1.3 Sections and Headings.................................................. 5
1.4 Singular Terms......................................................... 5
1.5 Schedules.............................................................. 5
ARTICLE 2
PURPOSE OF THIS AGREEMENT 6
ARTICLE 3
PATHEON'S OBLIGATIONS
3.1 Technical Transfer Activities.......................................... 6
3.2 Standard of Performance................................................ 7
3.3 Conversion of API and Components ...................................... 7
ARTICLE 4
SCICLONE'S OBLIGATIONS
4.1 Conformation of SciClone's Specifications.............................. 11
4.2 SciClone Supplies...................................................... 11
4.3 Supply Requirements Commitments........................................ 11
4.4 Order Campaigns........................................................ 11
ARTICLE 5
PRICE
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5.1 Price.................................................................. 11
5.2 [****]................................................................. 12
5.3 Adjustments Due to Technical Changes................................... 12
ARTICLE 6
ORDERS, DELIVERY, INVOICING,PAYMENT
AND PRODUCT DEFICIENCIES
6.1 [****]................................................................. 13
6.2 Orders and Forecasts................................................... 13
6.3 Firm Orders............................................................ 14
6.4 Reliance by Patheon.................................................... 14
6.5 [****]................................................................. 14
6.6 Shipments.............................................................. 14
6.7 Invoices and Payment .................................................. 15
6.8 Product Deficiencies................................................... 15
ARTICLE 7
CO-OPERATION
7.1 Quarterly Review....................................................... 16
7.2 Product Recalls and Returns ........................................... 16
7.3 Customer Questions and Complaints...................................... 17
7.4 Governmental Agencies.................................................. 17
7.5 Records and Accounting by Patheon...................................... 17
7.6 Access................................................................. 17
7.7 cGMP compliance and QA Audits.......................................... 18
ARTICLE 8
TERM, RENEWAL AND TERMINATION
8.1 Term................................................................... 18
8.2 Termination for Cause.................................................. 18
8.3 Product Discontinuation ............................................... 19
8.4 Obligations on Termination............................................. 20
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ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 Authority.............................................................. 20
9.2 Non-Infringement ...................................................... 20
9.3 Patheon's Warranty..................................................... 21
9.4 SciClone's Warranty ................................................... 21
9.5 Compliance with Law.................................................... 21
ARTICLE 10
LIABILITY AND INDEMNITY
10.1 Consequential Damages.................................................. 21
10.2 Limitation of Liability ............................................... 21
10.3 Patheon................................................................ 22
10.4 SciClone............................................................... 22
10.5 Reasonable Allocation of Risk.......................................... 23
ARTICLE 11
CONFIDENTIALITY
11.1 Disclosure............................................................. 23
11.2 Use of Information..................................................... 23
11.3 Exceptions............................................................. 23
11.4 Designation of Confidentiality......................................... 23
ARTICLE 12
DISPUTE RESOLUTION
12.1 Disputes............................................................... 24
12.2 Arbitration............................................................ 24
ARTICLE 13
MISCELLANEOUS
13.1 Trademarks............................................................. 24
13.2 Insurance.............................................................. 24
13.3 Independent Contractors................................................ 25
13.4 No Waiver.............................................................. 25
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13.5 Assignment and Subcontract............................................. 25
13.6 Force Majeure.......................................................... 25
13.7 Additional Product..................................................... 26
13.8 Notices................................................................ 26
13.9 Entire Agreement....................................................... 26
1310 Execution in Counterparts.............................................. 27
13.11 Governing Law.......................................................... 27
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MANUFACTURING AND SUPPLY AGREEMENT
THIS AGREEMENT made as of the first day of November, 2002 (the
"DATE OF EXECUTION")
B E T W E E N:
PATHEON ITALIA S.P.A.,
a corporation existing under the laws of ITALY,
(hereinafter referred to as "PATHEON"),
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SCICLONE PHARMACEUTICALS INTERNATIONAL LTD.
a corporation existing under the laws of British West
Indies,
(hereinafter referred to as "SCICLONE").
THIS AGREEMENT WITNESSES THAT in consideration of the rights
conferred and the obligations assumed herein, and for other good and valuable
consideration (the receipt and sufficiency of which are acknowledged by each
party), and intending to be legally bound the parties agree as follows:
ARTICLE 1
INTERPRETATION
1.1 DEFINITIONS. The following terms shall, unless the context
otherwise requires, have the respective meanings set out below and grammatical
variations of such terms shall have corresponding meanings:
"ACTIVE PHARMACEUTICAL INGREDIENT" OR "API" is "thymalfasin" or
"thymosin alpha-1" or "TA-1" drug substance and shall mean the compound
as better described in Schedule A (Appendix II), hereto and that is
supplied by SciClone to Patheon for the manufacture of API Vials as
defined below;
"ACTIVE PHARMACEUTICAL INGREDIENT VALUE" OR "API VALUE" means the value
to be attributed to the Active Pharmaceutical Ingredient for certain
purposes of this Agreement, calculated in accordance with Schedule C
hereto;
"ACTIVE PHARMACEUTICAL INGREDIENT BULK SPECIFICATION" OR "API BULK
SPECIFICATION" shall mean the specification for bulk Active
Pharmaceutical Ingredient as set forth in Schedule A hereto;
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"AFFILIATE" means:
(a) any person, firm or corporation which, directly or indirectly,
through one or more intermediaries, controls, is controlled
by, or is under common control with, another 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)
(b) a business entity which is owned by a party to this Agreement,
either directly or indirectly, by stock ownership or
otherwise; or
(c) a business entity, the majority ownership of which is directly
or indirectly common to the majority ownership of a party to
this Agreement;
"BUSINESS DAY" means a day other than a Saturday, Sunday or a day that
is a statutory holiday in either [****], or in California, The United
States of America;
"CGMPS" means current Good Manufacturing Practices published by the
European Commission in the "Guide to good manufacturing practice for
medicinal products"("The rules governing medicinal products for human
use", IV Volume), as specified by the competent Italian authorities;
"COMMENCEMENT DATE" means the date of commencement of the contracted
manufacturing activities by Patheon;
"COMPONENTS" means, collectively all the raw materials, excipients and
ingredients, all primary, secondary and outer packaging components
(including ampoule labels, product inserts and other labelling for the
Products), required to be used in order to produce the Products in
accordance with the Specifications, other than the following two items:
API and API vial labels that shall both be supplied by SciClone;
"CONFIDENTIAL INFORMATION" means a party's technology, data, know-how
or information whether written or oral, technical or non-technical,
including financial statements, reports, pricing, trade secrets, secret
processes, formulas, customer data (including customer lists), and the
like, that is disclosed to the other party;
"DEFICIENCY NOTICE" shall have the meaning ascribed thereto in Section
6.8 (a);
"DELIVERY DATE" shall mean the date set forth in the relevant Firm
Order by which Patheon must supply SciClone with Product;
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"DISPUTE" has the meaning specified in Section 12.1;
"FACILITY" means the manufacturing facility of Patheon located at
[****], where manufacturing of the Products under this Agreement shall
take place, as set forth in the GMP Technical Agreement;
"FIRM ORDERS" has the meaning specified in Subsection 6.2(b);
"GMP TECHNICAL AGREEMENT" means the standard agreement required under
the laws of the European Union (Directive 91/356/EEC) to be entered
into between Patheon and SciClone in respect of each Product, each such
agreement to be attached hereto in Schedule A;
"INITIAL TERM" has the meaning specified in Section 8.1
"INVENTORY" means all inventories of Components and Product
work-in-process produced or held by Patheon in connection with the
manufacture of the Products in accordance with the Specifications and,
specifically, excludes API or API vial labels.
"LABELLING" means all manufacturing operations related to the affixing
of labels to Products
"MA" means Marketing Authorization pursuant to Directive 00/00 XXX (as
amended by the following applicable provisions including Directive
2001/83/EU) or any implementation of it under the laws of a relevant
Member State, which for the Products means the authorization referred
to in Schedule A;
"ML" means Manufacturing Licence pursuant to Directive 00/000 XXX (as
amended by the following applicable provisions including Directive
2001/83/EU) or any implementation of it under the laws of a relevant
Member State, which for this Agreement means the authorization referred
to in Schedule A;
"MANUFACTURING REQUIREMENTS" has the meaning specified in Section 3.2;
"PATHEON" shall mean Patheon Italia S.p.A., a corporation existing
under the laws of [****] with its registered office at [****];
"PRODUCTS" shall mean the four types of Product that are to be
considered for this Agreement as better described below:
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- "API VIALS": bulk unlabelled or labelled vials
containing API in its formulation as described in detail in
the relevant Specifications and to be manufactured in
accordance with the cGMPs and any other Manufacturing
Requirements;
- "PLACEBO VIALS": vials NOT containing API as
described in detail in the relevant Specifications and to be
manufactured in accordance with the cGMPs and any other
Manufacturing Requirements;
- "DILUENT WFI AMPOULES": bulk unlabelled or labelled
ampoules filled with water (to be used for reconstitution of
the API vial) as described in detail in the relevant
Specifications and to be manufactured in accordance with the
cGMPs and any other Manufacturing Requirements.
- "PACKED PRODUCT": two labelled API vials packaged
together with two labelled Diluent WFI Ampoules in a thermo
moulded polypropylene tray and, together with a Patient
Information Leaflet, inserted into a carton, as described in
detail in the relevant Specifications and in the cGMPs and any
other Manufacturing Requirements;
"SCICLONE" means SciClone Pharmaceuticals International Ltd., P.O. Box
219GT, Strathvale House, North Church Street, Xxxxxx Town, Grand
Cayman, Cayman Islands, British West Indies;
"SCICLONE'S PRODUCT SPECIFICATIONS" OR "SPECIFICATIONS" means the
Technical Manufacturing, Release and relevant Regulatory files and
information, for each Product which contain documents relating to such
Products, including, without limitation:
(a) a detailed description for each Product, including its
physical and chemical characteristics and stability;
(b) product manufacturing and packaging instructions;
(c) product shipping and storage requirements;
(d) protocols for validating the processes and equipment to
manufacture the Products;
(e) quality control and quality assurance procedures and
analytical test methods for sampling, testing, documenting and
releasing: API, Components, in-process control and finished
Product;
(f) procedures and analytical test methods for testing the
stability of the Product;
(g) procedures and analytical test methods for cleaning of the
Product;
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(h) all environmental, health and safety information relating to
the Product including material safety data sheets, incident
reports, risk analyses, health concerns, preventative measures
and procedures for waste disposal; and
(i) any other technical information necessary to carry out the
contracted operations correctly in accordance with the
Marketing Authorization and any other legal requirements,
all as updated, amended and revised from time to time by SciClone in
accordance with the terms of this Agreement;
"TERRITORY" means [****]
"THIRD PARTY RIGHTS" means the Intellectual Property of any third
party; and
"YEAR" means the twelve-month period commencing, in the case of the
first Year of this Agreement, on the date of execution of this
Agreement, and thereafter commencing upon completion of the immediately
preceding Year.
1.2 [****]
1.3 SECTIONS AND HEADINGS. The division of this Agreement into
Articles, sections, subsections and Schedules and the insertion of headings are
for convenience of reference only and shall not affect the interpretation of
this Agreement. Unless otherwise indicated, any reference in this Agreement to a
Section or Schedule refers to the specified Section or Schedule to this
Agreement. In this Agreement, the terms "THIS AGREEMENT", "HEREOF", "HEREIN",
"HEREUNDER" and similar expressions refer to this Agreement and not to any
particular part, Section, Schedule or the provision hereof.
1.4 SINGULAR TERMS. Except as otherwise expressly provided herein
or unless the context otherwise requires, all references to the singular shall
include the plural and vice versa.
1.5 SCHEDULES. The following Schedules are attached to,
incorporated in and form part of this Agreement:
Schedule A - GMP Technical Agreement
Appendix I Products and Specifications.
Appendix II Component Specifications.
Appendix III Manufacturing Requirements -
All Manufacturing Procedures
and Instructions [****]
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Appendix IV Lot Numbering, Expiration
Dates and Variable Data
System.
Appendix V Quality Control
Specifications and Quality
Control Documentation [****]
Appendix VI Instructions for Packaging
[****] and Shipment
Appendix VII Product Release Protocol and
Retained Sample
Requirements.
Appendix VIII Placebo Specification
Schedule B - Price Lists for Products, Technology Transfer, Capital
Equipment and other Services
Schedule C - Agreed Value of Active Pharmaceutical Ingredient
Schedule D - [****]
Schedule E - [****]
ARTICLE 2
PURPOSE OF THIS AGREEMENT
Patheon shall toll manufacture and supply to SciClone the Products listed in
Schedule A (Appendix I) hereto for sale in the Territory at the Prices as
defined in Section 5.1 below and pursuant to all terms and conditions of this
Agreement. Subject to Section 6.1, SciClone shall purchase and Patheon shall
supply such quantities of Products as may be set forth in Firm Orders placed by
SciClone and accepted by Patheon under this Agreement.
At least 45 days prior to the commencement of the commercial manufacture of the
Product, the Parties shall agree in writing, in an "Addendum" to be attached
hereto, the countries where SciClone intends to sell and distribute the Product.
Accordingly, for the purposes of this Agreement, the Territory referred to in
Section 1.1 shall include the countries as set forth in the said Addendum and
any other countries which shall be agreed in writing between the Parties from
time to time during the term of this Agreement.
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ARTICLE 3
PATHEON'S OBLIGATIONS
3.1 TECHNICAL TRANSFER ACTIVITIES: Prior to the commencement of
commercial manufacture of the Product, Patheon shall perform the technical
transfer activities related to each Product as listed in and according to
Schedule B hereto (the "TECHNICAL TRANSFER ACTIVITIES").
3.2 STANDARD OF PERFORMANCE. Patheon shall manufacture and supply
to SciClone the Products in accordance with (i) the Specifications; (ii) any
other terms and conditions provided in the GMP Technical Agreement; (iii) the
conditions provided under the M.A. and the M.L., the cGMPs and any other
applicable legal requirements as specified by the competent Public Authorities
(hereinafter collectively the "MANUFACTURING REQUIREMENTS").
3.3 CONVERSION OF API AND COMPONENTS. Patheon shall carry out the
following activities:
(a) Patheon shall convert API and Components into Products;
(b) Patheon shall, at its expense, purchase from third party
suppliers all Components (other than those supplied by
SciClone) required for the manufacture of Products, unless
such purchase is expressly requested and prevented to do so by
SciClone. All Components shall meet the relevant
Specifications as described in Schedule A, as amended or
supplemented from time to time. Patheon must test all
Components in accordance with quality assurance procedures
provided by SciClone in the Specifications.
(C) (i) Patheon shall inspect and check API delivered by
SciClone, or by an agent of SciClone, in accordance
with the required Specifications as set down below
within 60 days following receipt at the Facility. In
the event that any API does not meet the API
Specification after testing in accordance with the
relevant Specifications, SciClone shall duly deliver
replacement API to Patheon at no additional cost to
Patheon. Upon receipt of API at Patheon, Patheon
shall analyze a sample of the API for:
(A) Identity [****];
(B) Purity [****]; and
(C) Moisture content [****].
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(ii) If the API sample fails to meet the Specifications,
Patheon shall not use the corresponding batch of API
but will immediately report the result to SciClone.
Patheon and SciClone shall promptly confer to discuss
the discrepancy and determine whether the material
shall be retested or replaced or what other action to
take.
(iii) After SciClone and Patheon have determined that API
meets the API Bulk Specification pursuant to the
relevant Specifications, Patheon shall bear the risks
of loss for the API to a maximum of [****] of any API
batch loss as calculated using the [****], including
without limitation loss due to improper Processing,
inadequate storage and theft. In any event, such API
loss coverage by Patheon shall be capped at a maximum
of [****] per Year.
(d) For the manufacture of API Vials, Patheon shall use API
supplied by SciClone. The quantity of API shall be 1.68 mg per
ml in formulation.
(e) Patheon will be responsible for proper storage and handling of
API, Components, work in process and Products in accordance
with the relevant Specifications set forth in Schedule A.
(f) Active Material Yield.
Patheon shall provide SciClone with a [****] inventory report
and reconciliation of the API held by Patheon, which shall
contain the following information for any [****]:
QUANTITY RECEIVED: The total quantity of API received at the
Facility during [****].
QUANTITY DISPENSED: The total quantity of API dispensed at the
Facility during [****]. The Quantity Dispensed is calculated
as [****].
QUANTITY CONVERTED: The total amount of API contained in the
Products produced with the Quantity Dispensed, delivered by
Patheon, and not rejected as deficient Product pursuant to
Section 6.8(c) or 7.2(c).
At the end of any Year, the "ACTUAL ANNUAL YIELD" or "AAY" at
the Facility in such Year is [****] and which is calculated as
follows:
[****]
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After Patheon has produced a minimum of [****] of Product and
has produced batches for at least [****] at the Facility
pursuant to this Agreement, the Parties will mutually agree on
the target yield in respect of such Product at the Facility
(each, a "TARGET YIELD"). Thereafter, Patheon shall strive to
maintain Actual Annual Yield levels for each Product above the
applicable Target Yield. If the Actual Annual Yield falls more
than [****] below the respective Target Yield in a Year,
Patheon shall reimburse SciClone for the cost of the shortfall
based on the following calculation:
[****]
In any event, in accordance with Section 10.2 below, such
reimbursement from Patheon to SciClone shall not exceed a
yearly amount of [****] of the overall API Value for Product
damaged and/or lost.
(g) Patheon shall [****].
(h) Quality Control and Quality Assurance. Patheon shall perform
the quality control and quality assurance testing as specified
in the GMP Technical Agreement and, in any event, as required
by any applicable laws to ensure that Patheon has manufactured
the Products in accordance with Manufacturing Requirements and
Specifications. Each time Patheon ships Products to SciClone,
it shall provide SciClone with a certificate of analysis that
sets out the test results for each batch of Products and that
certifies that such batch has been evaluated by Patheon's
Quality Control/Quality Assurance department and that the
Products comply with the Manufacturing Requirements and
Specifications;
(i) Product Specifications, Testing and Release:
(A) SciClone and Patheon acknowledge that the
Specifications and testing procedures set
forth in Schedule A may need to be changed
as the Parties gain experience with the
manufacture and testing of Product. Any such
changes must be agreed by the Parties in
writing.
(B) SciClone shall qualify Patheon for Product
Release to market according to SciClone's
protocol as set forth in Schedule A
-(Appendix VII).
(C) Any Out of Specification (OOS) results from
the testing of Product must be investigated
and documented by Patheon. Patheon will
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notify SciClone immediately of such results
and investigations and both Patheon and
SciClone will confer and agree as to what is
the best course of action to take.
(D) For each batch of Product shipped Patheon
shall supply to SciClone a copy of the
[****]. All courier costs associated with
sending of such documents shall be on the
account of [****].
(E) Future modifications may be made to [****]
by [****]. SciClone and Patheon shall
negotiate the cost and or implications of
implementing any such modifications.
(l) Patheon shall supply to SciClone a [****]. Such [****] shall
be obtained by [****] from the normal local regulatory
authorities and costs associated with obtaining and sending
such documents will be at [****] expense.
(m) [****] Testing. [****].
(n) Dedicated Equipment: All dedicated processing equipment [****]
as indicated in Schedule B, purchased at [****] cost, shall be
dedicated, for [****], to the manufacture of Product for
SciClone and shall be maintained (ordinary maintenance) by
Patheon in good working order for its intended use, at [****]
responsibility. In case that any extraordinary maintenance is
required, the Parties shall discuss in good faith the most
appropriate course of action. All such dedicated equipment
shall remain the property of SciClone and shall be returned to
SciClone upon termination of this Agreement.
(o) Packaging. Patheon shall supply approximately [****] of the
Products as [****] to SciClone and Patheon shall also carry
out the packaging of the remaining [****] of the Products for
the market of [****] as set out in the Specifications. In
addition, Patheon shall make arrangements for and implement
[****]. [****] shall be affixed on the Products and on the
shipping carton of each Product as outlined in the
Specifications and as required by the cGMPs. The SciClone
requirements to be used by Patheon for [****] is detailed in
Schedule A (Appendix IV) hereto. Subject to Section 5.3 below,
[****] make changes to labels, product inserts and other
packaging for the Products, which changes shall be submitted
[****] to all applicable governmental agencies and other third
parties responsible for the approval of the Products. [****]
shall not appear on the label nor anywhere else on the
packaging, inserts or on Products unless required by a
governmental authority or applicable laws or regulations
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(p) Packaging Artwork: Where Patheon is required to originate or
change artwork for the supply of any printed packaging
components such artwork shall be supplied by SciClone to
Patheon in an agreed format and the cost associated with the
set up and origination [****] Patheon costs as set forth in
Schedule B.
(q) During the term of this Agreement, the Parties may decide to
that it is in each Party's best interest to extend the
Territory to include [****]. In such case, the Parties shall
determine in good faith the consequences of the manufacture of
the Product for [****]; they shall negotiate in good faith all
relevant terms of the Agreement with due consideration to the
effect of such expansion of the Territory; and they shall
initiate the necessary steps to [****].
ARTICLE 4
SCICLONE'S OBLIGATIONS
4.1 CONFORMATION OF SCICLONE'S SPECIFICATIONS: On Patheon's
completion of the Technical Transfer Activities and subject to the provisions of
Section 5.3, SciClone will update and confirm SciClone's Specifications with
respect to the particular Product, to the extent required to reflect changes to
manufacturing and validation methods.
4.2 SCICLONE SUPPLIES. In order to facilitate the manufacture of
the Products by Patheon, SciClone shall, at its sole cost and expense, deliver
the API and the API vial labels to Patheon in the quantities specified on
Schedule A (Appendix I) hereto, which API shall be held by Patheon on behalf of
SciClone on the terms and conditions herein contained. All materials delivered
by SciClone in anticipation of Product production must arrive at the Facility by
at least the same date as the receipt of any related Firm Orders for Product.
The parties acknowledge and agree that title to the API shall at all times
belong to and remain the property of SciClone. Patheon agrees that any API
received by it shall only be used by Patheon to manufacture and test the
Products of SciClone.
4.3 [****]
4.4 [****]
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ARTICLE 5
PRICE
5.1 PRICE. Pursuant to the terms of this Agreement, SciClone shall
pay to Patheon for the Products the prices (the "PRICES") listed in Schedule B
hereto (such Prices being subject to adjustment in accordance the terms hereof).
The Prices for the Products listed in Schedule B are intended by the parties to
be [****]* 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., subject to the amendments to such prices
provided for in this Article 5. The prices for any Products delivered pursuant
to the terms of this Agreement during any period [****] shall be determined in
accordance with Section 5.2 below. The Prices are for [****].
Technical Transfer Activities, including the performance items listed in
Schedule B, shall be charged to [****] at the costs set out therein ("TECHNICAL
TRANSFER COST"). Prior to the commencement of each Technical Transfer Activity,
Patheon shall give SciClone written notice thereof.
5.2 [****]
5.3 ADJUSTMENTS DUE TO TECHNICAL CHANGES. Amendments to the
Specifications or the GMP Technical Agreement as requested by SciClone will only
be implemented following a technical and cost review by Patheon and are subject
to SciClone and Patheon reaching agreement as to such revisions, including the
prices specified in Schedule B necessitated by any such amendment. If SciClone
and Patheon agree to such revisions including the prices, the proposed change in
Specifications shall be implemented, and the price change shall become effective
only with respect to those orders of Products that are manufactured in
accordance with the revised Specifications. [****].
Should a change in the Specifications or Manufacturing Requirements become
necessary in order to allow Patheon to guarantee the performance of the
activities in a state of the art way or to comply with new provisions or orders
of the Public Authorities, the above provisions of this Section 5.3 shall apply.
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ARTICLE 6
ORDERS, DELIVERY, INVOICING, PAYMENT
AND PRODUCT DEFICIENCIES
6.1 [****]
6.2 ORDERS AND FORECASTS. Subject to [****], SciClone shall
provide Patheon with the following:
(a) concurrent with the execution of this Agreement, a [****]
forecast of the volume of each Product that SciClone then
anticipates will be required to be produced and delivered to
SciClone during [****]. Such forecast will be updated by
SciClone [****] and updated forthwith upon SciClone
determining that the volumes for the [****] contemplated in
the most recent of such forecasts has changed by more than
[****]; and
(b) on or before [****], firm written orders ("FIRM ORDERS") for
the Products to be produced and delivered to SciClone during
[****] shall be delivered by [****].
6.3 FIRM ORDERS. The Firm Orders submitted to Patheon pursuant to
Section 6.2(b) shall specify SciClone's purchase order number, quantities by
Product type, monthly delivery schedule and any other elements necessary to
ensure the timely production and delivery of the Products by Patheon. The
quantities of Products ordered in such written orders shall be firm and binding
on SciClone and shall not be subject to reduction.
6.4 RELIANCE BY PATHEON. SciClone understands and acknowledges
that Patheon will rely on the Firm Orders submitted pursuant to Section 6.2(b)
in ordering the Components required to fulfill such Firm Orders. In addition,
SciClone understands that to ensure an orderly supply of such Components and to
achieve economies of scale in the costs of such Components therefore, it may be
desirable for Patheon to purchase such Components in sufficient volumes to meet
the production requirements for Products during part or all of the forecasted
periods as defined in Section 6.2(a) or to meet the production requirements of
any longer period as Patheon and SciClone may agree to. Accordingly, SciClone
agrees that purchases may be made by Patheon in respect of the Components
identified in Schedule A to satisfy the production requirements for Products for
forecasted periods identified opposite such Components, and in respect of such
other purchases to meet production requirements during such longer periods as
may be agreed to in writing from time to time by SciClone at the request of
Patheon. If such Components are not included in finished Products purchased by
SciClone within six months after the forecasted month in respect of which such
purchases have been made (or such longer period
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as the parties may agree), SciClone will pay to Patheon its costs thereof and,
in the event such Components are incorporated into Products subsequently
purchased by SciClone, SciClone will receive credit for any costs of such
Components previously paid to Patheon by SciClone.
6.5 [****]
6.6 SHIPMENTS. Deliveries of Products shall be made [****]. Such
title as Patheon has in Products and risk of loss or of damage to Products shall
remain with Patheon until Patheon delivers Products to the carrier for shipment
at the Facility at which time title and risk of loss or damage shall transfer to
SciClone. Patheon shall, in accordance with SciClone's instructions, (i) arrange
for shipping and insurance, to be paid by SciClone and (ii) at SciClone's risk
and expense, obtain any export license or other official authorization and carry
out all customs formalities necessary to export the Products. SciClone may
select the freight carrier used by Patheon to ship Products, informing Patheon
of the name thereof in reasonable advance, and may monitor Patheon's shipping
and freight sub contracting practices as they pertain to this Agreement.
Transport conditions shall be based upon SciClone's Specifications for the
transportation of the Products as set down in Schedule A (Appendix VI).
6.7 INVOICES AND PAYMENT. Except as otherwise provided in this
Agreement, Patheon shall charge SciClone for only those Products that are either
shipped to SciClone or that are requested by SciClone to be retained by Patheon
(retained samples) and shall submit to SciClone, with each shipment of Products,
an invoice covering such shipment. Each such invoice shall, to the extent
applicable, identify SciClone purchase order number, Product numbers, names and
quantities, unit price, freight charges and the total amount to be remitted by
SciClone. SciClone shall pay all such invoices within 30 (thirty) days of the
date of each invoice.
6.8 PRODUCT DEFICIENCIES.
(a) Inspection. SciClone shall inspect the Products manufactured
by Patheon upon receipt thereof and, within 45 (forty-five)
days, shall give Patheon written notice (a "DEFICIENCY
NOTICE") of all claims for Products that deviate from the
Specifications, cGMPs or from any other Manufacturing
Requirements. Should SciClone fail to provide Patheon with
written notice of its acceptance or rejection of the delivery
within 45 (forty-five) days of receipt of a delivery of
Products, then the delivery shall be deemed to have been
accepted by SciClone on the 45th (forty-fifth) day after
delivery. Except as set out in Section 7.2, Patheon shall have
no liability for any deviations for which it has not received
notice within such 45 (forty-five) day period.
(b) Determination of Deficiency. Upon receipt of a Deficiency
Notice, Patheon shall have 15 (fifteen) days to advise
SciClone by notice in writing that it disagrees with
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the contents of such Deficiency Notice. If SciClone and
Patheon fail to agree within 10 (ten) days after Patheon's
notice to SciClone as to whether any Products identified in
the Deficiency Notice deviate from the Specifications, the
cGMPs or from any other Manufacturing Requirements, then the
parties shall mutually select an independent laboratory to
evaluate if the Products deviate from the Specifications, the
cGMPs or from any other Manufacturing Requirements. Such
evaluation shall be binding on the parties, and if such
evaluation certifies that any Products deviate from the
Specifications, the cGMPs or from any other Manufacturing
Requirements, SciClone may reject those Products in the manner
contemplated by Section 6.8(c). If such evaluation does not so
certify in respect of any such Products, then SciClone shall
be deemed to have accepted delivery of such Products on the
40th (fortieth) day after delivery.
(c) Product Rejection. Subject to the provisions of Sections
6.8(a) and 10.2(b), SciClone has the right to reject and
return, at the expense of Patheon, any portion of any shipment
of Products that deviates from the Specifications, the cGMPs
or from any other Manufacturing Requirements, without
invalidating any remainder of such shipment, to the extent
that such deviation arises from Patheon's failure to
manufacture the Products in accordance with the
Specifications, the cGMPs or any other Manufacturing
Requirements.
(d) Shortages. Claims for shortages in the amount of Products
shipped by Patheon shall be dealt with as may reasonably be
agreed to by the parties.
ARTICLE 7
CO-OPERATION
7.1 QUARTERLY REVIEW. Each party shall forthwith upon execution of
this Agreement appoint one of its employees to be a relationship manager
responsible for liaison between the parties. The relationship managers shall
communicate on a regular basis to review the current status of the business
relationship and manage any issues that have arisen; and they shall meet any
time requested by either of the parties in order to examine technical and/or
commercial issues relative to the performance of this Agreement which are
material and particularly urgent.
7.2 PRODUCT RECALLS AND RETURNS.
(a) Product Recalls. Patheon and SciClone shall each maintain
records as may be necessary to permit a recall or a field
correction of any Products delivered to SciClone or customers
of SciClone, effected voluntarily or under a threat of, or a
directive by, any governmental agency. Each party shall give
notice within one Business Day by telephone (to be confirmed
in writing) to the Director of Quality Control / Quality
Assurance of the other party upon discovery that any Products
should be recalled or corrected, or may be required to be
recalled or corrected,
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and each party upon receiving any such notice or upon any such
discovery, shall cease and desist from further shipments of
such Products in its possession or control until a decision
has been made whether a recall or some other corrective action
is necessary. The decision to initiate a recall or to take
some other corrective action, if any, shall be made and
implemented by SciClone. Patheon will co-operate as reasonably
required by SciClone, having regard to all applicable laws and
regulations.
(b) Product Returns. SciClone shall have the responsibility for
handling customer returns of the Products. Patheon shall
provide SciClone with such assistance as SciClone may
reasonably need to handle such returns.
(c) Patheon's Responsibility. To the extent that a recall or
return results from, or arises out of, a failure by Patheon to
manufacture the Products in accordance with the Manufacturing
Requirements, such recall or return shall be made at Patheon's
cost and expense, and Patheon shall use its best efforts to
replace the recalled or returned Products with new Products
within 60 (sixty) days from the date that SciClone
definitively notifies Patheon about the recalled or returned
Products, contingent upon the receipt or availability from
SciClone of all Active Pharmaceutical Ingredient. Subject to
Section 10.2(b), Patheon's cost for such API shall be limited
to [****] [****]
7.3 CUSTOMER QUESTIONS AND COMPLAINTS. SciClone shall have the
sole responsibility for responding to questions and complaints from SciClone's
customers. Questions or complaints received by Patheon from SciClone's customers
shall be promptly referred to SciClone. Patheon shall co-operate as reasonably
required to allow SciClone to determine the cause of and resolve any customer
questions and complaints. Such assistance shall include follow-up
investigations, including testing. In addition, within 10 days from the date of
request, Patheon shall provide SciClone with all necessary information that will
enable SciClone to respond properly to questions or complaints relating to the
Products. Subject to Section 10.2(b), unless it is determined that the cause of
any customer complaint resulted from a failure by Patheon to manufacture the
Products in accordance with the Manufacturing Requirements, all costs incurred
in respect of this Section 7.3 shall be borne by SciClone.
7.4 GOVERNMENTAL AGENCIES. Each party may communicate with any
governmental agency, including but not limited to governmental agencies
responsible for granting regulatory approval for the Products, regarding such
Products if in the opinion of that party's counsel, such communication is
necessary to comply with the terms of this Agreement or the requirements of any
law, governmental order or regulation; provided, however, that unless in the
reasonable opinion of its counsel there is a legal prohibition against doing so,
such party shall permit the
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other party to accompany and take part in any communications with the agency,
and to receive copies of all such communications from the agency.
7.5 RECORDS AND ACCOUNTING BY PATHEON. Patheon shall keep records
of the manufacture, testing and shipping of the Products, and retain samples of
such Products as are necessary to comply with manufacturing regulatory
requirements applicable to Patheon, as well as to assist with resolving product
complaints and other similar investigations. Copies of such records and samples
shall be retained for a period of five years following the date of manufacture,
or longer if required by law. SciClone is responsible for retaining samples of
the Products necessary to comply with the legal/regulatory requirements
applicable to SciClone.
SciClone may inspect the above reports and records during normal business hours
and with reasonable advance written notice, provided a Patheon representative is
present during any such inspection.
Each Party shall promptly notify the other Party of any inspections by any
governmental agency involving the Products.
7.6 ACCESS. Patheon shall provide SciClone with reasonable access
at mutually agreeable times to the Facility in which the Products are
manufactured, stored, handled or shipped in order to permit SciClone's
verification of Patheon's compliance with the terms of this Agreement and with
all applicable laws and regulations. Patheon shall also provide access to
SciClone employees and its contractors, if duly authorised by SciClone in
writing and upon prior written notice to Patheon, to perform annual inventory
audit. Upon SciClone's request, Patheon shall provide the necessary copies of
batch records and QC test result documents and any other pertinent documents of
regulatory and accounting importance.
7.7 cGMP COMPLIANCE AND QA AUDITS. Upon SciClone's written request
to Patheon, SciClone shall have the right to have representatives visit
Patheon's manufacturing facilities during normal business hours to review
Patheon's manufacturing operations, to have access to any relevant records in
connection with such manufacture and assess its compliance with cGMP and quality
assurance standards and to discuss any related issues with Patheon's
manufacturing and management personnel. Upon completion of Patheon's internal
review and product batch release, SciClone shall have the right to request
copies of Patheon's manufacturing records, including its batch records and
analytical records, for the purposes of assuring product quality and compliance
with agreed-upon manufacturing procedures and specifications. SciClone
acknowledges that all copies of Patheon's manufacturing records shall be
protected under the confidentiality provisions of Article 11.
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ARTICLE 8
TERM, RENEWAL AND TERMINATION
8.1 TERM. This Agreement shall become effective as of the Date of
Execution and shall expire [****] from the date it becomes effective (the
"INITIAL TERM"), unless [****].
This Agreement shall automatically continue after the Initial Term for
successive terms [****] unless either party gives written notice to the other
party of its intention to terminate this Agreement at least 180 (one hundred and
eighty) days prior to the end of the current term.
8.2 TERMINATION FOR CAUSE.
(a) Either party at its sole option may terminate this Agreement
upon written notice in circumstances where the other party has
failed to remedy a material breach of any of its
representations, warranties or other obligations under this
Agreement within 60 (sixty) days following receipt of a
written notice (the "REMEDIATION PERIOD") of said breach that
expressly states that it is a notice under this Section 8.2(a)
(a "BREACH NOTICE"). The aggrieved party's right to terminate
this Agreement pursuant to this Section 8.2(a) may only be
exercised for a period of 60 (sixty) days following the expiry
of the Remediation Period (in circumstances where the breach
has not been remedied) and if the termination right is not
exercised during this period then the aggrieved party shall be
deemed to have waived the breach of the representation,
warranty or obligation described in the Breach Notice.
(b) Either party at its sole option may immediately terminate this
Agreement upon written notice, but without prior advance
notice, to the other party in the event that (i) the other
party is declared insolvent or bankrupt by a court of
competent jurisdiction; (ii) a voluntary petition of
bankruptcy is filed in any court of competent jurisdiction by
such other party; or (iii) this Agreement is assigned by such
other party for the benefit of creditors.
(c) Should the parties not be able to reach agreement pursuant to
Section 13.6 below within 2 (two) weeks of the occurrence of
an event of force majeure, or should the event of force
majeure extend for more than 3 (three) months, each of the
parties shall be entitled to terminate this Agreement by
giving 30 (thirty) days written notice thereof to the other
party. Such notice shall indicate, inter alia, the date
provided for the termination of the Agreement.
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(d) SciClone may terminate this Agreement as to any Product upon
30 (thirty) days' written notice in the event that any
governmental agency takes any action, or raises any objection,
that prevents SciClone from importing, exporting, purchasing
or selling such Product.
(e) SciClone may terminate this Agreement in the event that
Patheon does not have the permits and licenses required by law
and technical know-how to manufacture the Products in the
Facility.
(f) Either party may terminate this Agreement on 6 (six) months'
prior written notice if either party assigns pursuant to
Section 13.5 any of its rights under this Agreement to an
assignee that, in the opinion of the non-assigning party
acting reasonably, is (i) not a credit worthy substitute for
either party, (ii) a competitor of either party or (iii) a
person with whom either party has had prior unsatisfactory
business relations.
(g) [****]
8.3 PRODUCT DISCONTINUATION. Subject to Section 6.1, SciClone
shall provide to Patheon [****] prior written notice, if it intends to no longer
order a Product due to that Product's discontinuance in the market.
8.4 OBLIGATIONS ON TERMINATION. If this Agreement expires or is
terminated in whole or in part for any reason, then (in addition to any other
remedies Patheon may have in the event of default by SciClone, including any
remedy pursuant to Section 6.1):
a) [****];
b) [****];
c) [****]; and
d) [****]
Any termination or expiration of this Agreement shall not affect any outstanding
obligations or payments due hereunder prior to such termination or expiration,
nor shall it prejudice any other remedies that the parties may have under this
Agreement. For greater certainty, termination of this Agreement for any reason
shall not affect the obligations and responsibilities of the parties pursuant to
Article 10, all of which survive any termination.
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ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 AUTHORITY. Each party represents and warrants that it has the
full right and authority to enter into this Agreement, and that it is not aware
of any impediment that would inhibit its ability to perform its obligations
hereunder
9.2 NON-INFRINGEMENT. SciClone represents and warrants that:
(a) the Specifications for each of the Products are its or its
Affiliate's property and that SciClone may lawfully disclose
these Specifications to Patheon;
(b) any Intellectual Property utilized by Patheon in connection
with the manufacturing of the Products according to the
Specifications (i) is SciClone's or its Affiliate's
unencumbered property, (ii) may be lawfully used as directed
by SciClone, and (iii) such use does not infringe and will not
infringe any Third Party Rights;
(c) the carrying out of the manufacturing activities by Patheon in
respect of any Product pursuant to this Agreement or use or
other disposition of any Product by Patheon as may be required
to perform its obligations under this Agreement does not and
will not infringe any Third Party Rights;
(d) there are no actions or other legal proceedings, the subject
of which is the infringement of Third Party Rights related to
any of the Specifications, or any of the API and the
Components, or the sale, use or other disposition of any
Product made in accordance with the Specifications;
(e) the Specifications for all Products conforms to all applicable
cGMPs, laws and regulations; and
(f) the Products, if labelled and manufactured in accordance with
the Specifications and in compliance with applicable cGMPs (i)
may be lawfully sold and distributed in every jurisdiction in
which SciClone markets such Products, (ii) will be fit for the
purpose intended, and (iii) will be safe for human
consumption.
9.3 PATHEON'S WARRANTY. Patheon represents and warrants that the
Patheon has all the applicable permits and licenses and technical know-how to
manufacture the Products in the Facility.
9.4 SCICLONE'S WARRANTY. SciClone shall be solely responsible for
obtaining or maintaining any permits or other regulatory approvals in respect of
the Products or the Specifications, including, without limitation, all marketing
and post-marketing approvals.
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9.5 COMPLIANCE WITH LAWS. Each party, in connection with its performance under
this Agreement, shall comply with all applicable laws, rules, regulations,
orders and guidelines.
ARTICLE 10
LIABILITY AND INDEMNITIES
10.1 CONSEQUENTIAL DAMAGES. Neither party shall be liable to the
other in contract, tort, negligence, breach of statutory duty or otherwise for
any (direct or indirect) loss of profits, of production, of anticipated savings,
of business or goodwill or for any liability, damage, costs or expense of any
kind incurred by the other party of an indirect or consequential nature.
10.2 LIMITATION OF LIABILITY.
(a) Active Pharmaceutical Ingredient. Patheon shall not be
responsible for any loss or damage to the API, except where
such loss or damage occurs while such ingredient is located at
the Facility and results from a failure by Patheon to carry
out the manufacturing activities in accordance with the
Manufacturing Requirements or is otherwise due to Patheon's
gross negligence or intentional misconduct. [****].
(b) Products. Except in circumstances where Patheon has failed to
carry out the manufacturing activities in accordance with the
Manufacturing Requirements, and, in any event, except
Patheon's gross negligence or intentional misconduct, Patheon
shall not be liable nor have any responsibility for any
deficiencies in, or other liabilities associated with, any
Product manufactured by it, including, without limitation, any
deficiencies with respect to the Specifications, the safety,
efficacy or marketability of the Products or any distribution
risk. Except as set out in Section 7.2(c), if Patheon has
failed to carry out the manufacturing activities in accordance
with the Manufacturing Requirements, then Sciclone shall have
no obligation to pay for such Products. [****]
10.3 PATHEON. Patheon agrees to defend, indemnify and hold
SciClone, its officers, employees, Affiliates and agents harmless against any
and all losses, damages, costs, claims, demands, judgments and liability to,
from and in favour of third parties (other than Affiliates) resulting from, or
relating to any claim of personal injury or property damage to the extent that
such injury or damage is the result of a failure by Patheon to carry out the
manufacturing activities in accordance with the Manufacturing Requirements or
any breach of this Agreement by Patheon, including, without limitation, any
representation or warranty contained herein,
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except to the extent that any such losses, damages, costs, claims, demands,
judgments and liability are due to the negligence or wrongful act(s) of
SciClone, its officers, employees or agents or Affiliates. SciClone shall
promptly notify Patheon of any such claim, shall use commercially reasonable
efforts to mitigate the effects of such claim, shall reasonably cooperate with
Patheon in the defence of such claim and shall permit Patheon to control the
defence and settlement of such claim, all at Patheon's cost and expense.
10.4 SCICLONE. SciClone agrees to defend, indemnify and hold
Patheon, its officers, employees and agents harmless against any and all losses,
damages, costs, claims, demands, judgments and liability to, from and in favour
of third parties (other than Affiliates) resulting from, or relating to any
claim of infringement or alleged infringement of any Third Party Rights in
respect of the Products, and any claim of personal injury or property damage to
the extent that such injury or damage is the result of a breach of this
Agreement by SciClone, including, without limitation, any representation or
warranty contained herein, except to the extent that any such losses, damages,
costs, claims, demands, judgments and liability are due to the negligence or
wrongful act(s) of Patheon, its officers, employees or agents. Patheon shall
promptly notify SciClone of any such claims, shall use commercially reasonable
efforts to mitigate the effects of such claim, shall reasonably cooperate with
SciClone in the defence of such claims and shall permit SciClone to control the
defence and settlement of such claims, all at SciClone's cost and expense.
10.5 REASONABLE ALLOCATION OF RISK. The parties acknowledge and
agree that the provisions of this Agreement (including, without limitation, this
Article 10) are reasonable and create a reasonable allocation of risk having
regard to the relative profits the parties respectively expect to derive from
the Products, and that Patheon, in its fees for carrying out the manufacturing
activities, has not accepted a greater degree of the risks arising from the
manufacture, distribution and use of the Products, based on the fact that
SciClone has developed and holds the marketing approval for the Products and
requires Patheon to manufacture and label the Products strictly in accordance
with the Specifications, and that SciClone and not Patheon is in a position to
inform and advise potential users of the Products as to the circumstances and
manner of use of the Products.
ARTICLE 11
CONFIDENTIALITY
11.1 DISCLOSURE. During and in furtherance of this Agreement, each
of the parties hereto may disclose certain of its Confidential Information to
the other party.
11.2 USE OF INFORMATION. During the Initial Term and any renewals
of this Agreement, and for a period of five years from the termination of this
Agreement, each of the parties hereto agrees (i) to use the Confidential
Information only in connection with the terms of this Agreement; (ii) to treat
the Confidential Information as it would its own proprietary information; and
(iii) to take all reasonable precautions to prevent the disclosure of the
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Confidential Information to any third party, other than an Affiliate, without
the prior written consent of the other party.
11.3 EXCEPTIONS. Each of Patheon and SciClone shall be relieved of
any and all of the obligations under Section 11.2 regarding Confidential
Information which (i) was known by the recipient prior to receipt hereunder;
(ii) at the time of disclosure, was generally available to the public, or which
after disclosure hereunder becomes generally available to the public through no
fault attributable to a party hereto; (iii) is hereafter made available for use
or disclosure from any third party having a right to do so; or (iv) it is
required to make such disclosure as a result of an application of a law
applicable to it or any of its Affiliates or an order of a court or regulatory
tribunal.
11.4 DESIGNATION OF CONFIDENTIALITY. All oral information shall be
reduced to writing forthwith after disclosure. Each party shall either xxxx its
Confidential Information "CONFIDENTIAL" or "PROPRIETARY" or ensure that it is
covered by a notice indicating that such information is confidential. For
greater certainty, a verbal disclosure by a party of its Confidential
Information shall be followed by a written summary of the conversation marked
"CONFIDENTIAL" and be delivered to the other party within thirty days of the
conversation.
ARTICLE 12
DISPUTE RESOLUTION
12.1 DISPUTES. In the event of any dispute, claim, question or
disagreement arising out of or relating to this Agreement (a "DISPUTE"), the
parties shall use all reasonable efforts to settle such Dispute by amicable
negotiations within a period of [****]* 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. of one party giving
notice of the Dispute to the other party.
12.2 ARBITRATION. Should the parties not to settle the dispute by
amicable negotiations within the such period of [****], all disputes shall be
finally settled under the rules of conciliation and arbitration of the
International Chamber of Commerce (the "RULES") by three arbitrators, reasonably
fluent in [****].
The arbitration procedure will take place in [****] and will be conducted in
[****] language.
The decision of the arbitrators will be final and binding upon the parties.
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ARTICLE 13
MISCELLANEOUS
13.1 TRADEMARKS. SciClone and Patheon hereby acknowledge that
neither party has, nor shall it acquire, any interest in any of the other
party's trademarks or trade names unless otherwise expressly agreed to in
writing. Each party agrees not to use any trademark or trade name of the other
party, except as specifically authorized by the other party or as required for
the performance of its obligations under this Agreement.
Matters of competition law, including admissibility, in respect of package
design, package inserts and other elements, and matters of intellectual property
law shall be the responsibility of SciClone, which undertakes to hold Patheon
harmless and indemnified against any claim for damages and/or expenses which can
in any way be attributed to a breach of competition law or intellectual property
law.
13.2 INSURANCE. Each party shall maintain comprehensive general
liability insurance, with a leading insurance company, including blanket
contractual liability insurance covering the obligations of that party under
this Agreement through the term of this Agreement and for five years thereafter,
which insurance shall afford limits of not less than [****]* 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.
for each occurrence for bodily injury liability, personal injury liability,
products liability, property damage liability, and contractual liability. Each
party will provide the other with a certificate of insurance evidencing the
above and showing the name of the issuing company, the policy number, the
effective date, the expiration date and the limits of liability. The insurance
certificate shall further provide for a minimum of thirty days' written notice
to the recipient of a cancellation of, or material change in, the insurance.
13.3 INDEPENDENT CONTRACTORS. The parties are independent
contractors and this Agreement shall not be construed to create between Patheon
and SciClone any other relationship such as, by way of example only, that of
employer-employee, principal agent, joint-venture, co-partners or any similar
relationship, the existence of which is expressly denied by the parties hereto.
13.4 NO WAIVER. The tolerance by either of the parties, even if
continued or repeated, of breaches by the other party of provisions contained in
any clause of this Agreement shall not constitute a waiver nor it may in any way
affect the validity of the clause being breached, so long as the breach is
contested within 60 (sixty) days of the date of the event by way of registered
letter with return receipt.
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13.5 ASSIGNMENT AND SUBCONTRACT. Neither party may assign this
Agreement or any of its rights nor do obligations hereunder except with the
written consent of the other party, such consent not to be unreasonably
withheld.
Notwithstanding the foregoing provisions of this Section 13.5, either party may
assign this Agreement to any of its Affiliates or to a successor to or purchaser
of all or substantially all of its business, provided that such assignee
executes an agreement with the non-assigning party hereto whereby it agrees to
be bound hereunder.
Patheon may subcontract, in whole or in part, to third parties the performance
of the activities contemplated under Article 3 above entrusted to it by this
Agreement. In any event, before subcontracting the performance of the aforesaid
activities to third parties, Patheon shall receive SciClone's written approval,
such consent not to be unreasonably withheld.
13.6 FORCE MAJEURE. Neither party shall be liable for the failure
to perform its obligations under this Agreement if such failure is occasioned by
a cause or contingency beyond such party's reasonable control, including, but
not limited to, strikes or other labour disturbances, lockouts, riots, wars,
fires, floods, storms, interruption of or delay in transportation, or compliance
with any order or regulation of any government entity acting within colour of
right. A party claiming a right to excused performance under this Section 13.6
shall immediately notify the other party in writing of the extent of its
inability to perform, which notice shall specify the occurrence beyond its
reasonable control that prevents such performance.
The party affected by an event of force majeure must give prompt notice thereof
to the other party, identifying such event and indicating its consequences from
the stand point of the fulfilment of contractual obligations.
The party affected by an event of force majeure must use every effort in order
to continue to perform this Agreement and if absolutely necessary the parties
shall co-operate in order to agree upon terms and conditions different from
those contained herein, for the continuance of the Agreement itself for the
entire period of time the event of force majeure continues.
13.7 ADDITIONAL PRODUCT. Additional products may be added to this
Agreement and such additional products shall be governed by the general
conditions hereof with any special terms (including, without limitation, price)
governed by an addendum hereto.
13.8 NOTICES. All communications and other notices under this
Agreement shall be in writing and shall be considered as duly given if delivered
personally or sent by registered letter with return receipt or transmitted by
fax, confirmed by registered letter sent within two (2) working days following
the date of the fax to the parties at the following addresses (or at any other
address which the parties shall have indicated giving notice thereof in the ways
set forth above):
a) as to SciClone, to:
SCICLONE PHARMACEUTICAL INTERNATIONAL LTD.
-25-
Room 3401A, Windsor House,
000 Xxxxxxxxxx Xxxx, Xxxxxxxx Xxx
Xxxx Xxxx
Attention: Xx. Xxxxxx (Ram) Xxxxxx, Ph.D.,
Vice President, Product Development and Manufacturing
Tel. No.: x000-0000-0000 (in Hong Kong)
Fax No.: x000-0000-0000 (in Hong Kong)
Tel. No.: x000-000-0000 (in USA)
Fax No: x000-000-0000(in USA)
b) as to Patheon, to:
PATHEON ITALIA S.P.A.
[****]
Italy
Attention: Managing Director
Tel. No.: [****]
Fax No.: [****]
All the communications and other notices under this Agreement which have been
delivered in person or which have been transmitted by fax and confirmed by
registered letter sent within 2 (two) working days following the date of the
fax, shall be considered as received by the addressee respectively upon the date
of delivery in person or on the third working day subsequent to that of the date
of the fax.
13.9 ENTIRE AGREEMENT. This Agreement constitutes the full,
complete, final and integrated agreement between the parties hereto relating to
the subject matter hereof and supersedes all previous written or oral
negotiations, commitments, agreements, transactions or understandings with
respect to the subject matter hereof. Any modification, amendment or supplement
to this Agreement must be in writing and signed by authorized representatives of
both parties.
13.10 EXECUTION IN COUNTERPARTS. This Agreement shall be executed in
three originals, all of which together shall constitute one and the same
instrument.
13.11 GOVERNING LAW. This Agreement shall be construed and enforced
in accordance with the laws of [****].
IN WITNESS WHEREOF, the duly authorized representatives of the
parties have executed this Agreement as of the date first written above.
--------------------
* 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-
PATHEON ITALIA S.P.A.
_______________________________
[****]
Managing Director of Patheon Italia S.p.A.
SCICLONE PHARMACEUTICALS INTERNATIONAL LTD.
_______________________________
By Xx. Xxxxxx Xxxxxx and
Xx. Xxxxxx Xxxxxxx
_______________________________
-27-
SCHEDULE A
GMP TECHNICAL AGREEMENT
[****]
--------------------
* Certain information on this schedule encompassing 16 pages has been omitted
and filed separately with the commission. Confidential treatment has been
requested with respect to the omitted portions.
APPENDIX I
SPECIFICATIONS
PRODUCTS:
[****]
--------------------
* Certain information on this appendix encompassing 8 pages has been omitted and
filed separately with the commission. Confidential treatment has been requested
with respect to the omitted portions.
APPENDIX II
STARTING COMPONENTS AND SPECIFICATIONS
[****]
--------------------
* Certain information on this appendix encompassing 73 pages has been omitted
and filed separately with the commission. Confidential treatment has been
requested with respect to the omitted portions.
APPENDIX III
MANUFACTURING PROCEDURES AND MANUFACTURING INSTRUCTIONS
[****]
--------------------
* Certain information on this appendix encompassing 26 pages has been omitted
and filed separately with the commission. Confidential treatment has been
requested with respect to the omitted portions.
APPENDIX IV
LOT NUMBERING, EXPIRATION DATES AND VARIABLE DATA SYSTEM
[****]
--------------------
* Certain information on this appendix encompassing 6 pages has been omitted and
filed separately with the commission. Confidential treatment has been requested
with respect to the omitted portions.
APPENDIX V
QUALITY CONTROL SPECIFICATIONS AND
QUALITY CONTROL DOCUMENTATION
[****]
--------------------
* Certain information on this appendix encompassing 36 pages has been omitted
and filed separately with the commission. Confidential treatment has been
requested with respect to the omitted portions.
APPENDIX VI
SHIPPING AND DELIVERY INSTRUCTIONS
[****]
--------------------
* 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.
APPENDIX VII
PRODUCT RELEASE PROTOCOL
[****]
--------------------
* Certain information on this appendix encompassing 3 pages has been omitted and
filed separately with the commission. Confidential treatment has been requested
with respect to the omitted portions.
APPENDIX VIII
PLACEBO SPECIFICATION
[****]
--------------------
* 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.
SCHEDULE B
PRODUCT AND SERVICE PRICE LIST, TECHNOLOGY TRANSFER,
CAPITAL EQUIPMENT AND OTHER SERVICES
[****]
--------------------
* Certain information on this schedule encompassing 2 pages has been omitted and
filed separately with the commission. Confidential treatment has been requested
with respect to the omitted portions.
SCHEDULE C
AGREED VALUE OF ACTIVE PHARMACEUTICAL INGREDIENT
[****]
--------------------
* 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.
SCHEDULE D
[****]
--------------------
* 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.
SCHEDULE E
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* 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.