Agreement for Clinical Supply - Gensia Sicor Pharmaceuticals Inc. and Seattle Genetics Inc.
AGREEMENT FOR CLINICAL SUPPLY
THIS AGREEMENT (the "Agreement") is effective as of October 9, 2002 (the
"Effective Date"), by and between GENSIA SICOR PHARMACEUTICALS, INC., and its
wholly-owned subsidiary GENSIA SICOR PHARMACEUTICAL SALES, INC., a Delaware
corporation with offices at 19 Hughes, Irvine, California 92618-1902
(collectively, "Gensia Sicor"), and Seattle Genetics, a Delaware corporation,
with offices at 21823 30/th/ Drive SE, Bothell, WA 98021 ("SEATTLE GENETICS").
RECITALS
WHEREAS, Gensia Sicor is in the business of developing, manufacturing,
testing packaging, and marketing sterile injectable pharmaceutical products;
and
WHEREAS, SEATTLE GENETICS desires to utilize Gensia Sicor to develop,
manufacture, test, and package clinical supplies of the product designated by
SEATTLE GENETICS as set forth in Exhibit A and Exhibit B hereto, as amended
from time to time in accordance with the terms and conditions set forth
herein; and
WHEREAS, Gensia Sicor desires to provide services to SEATTLE GENETICS for the
Product agreed to by both parties in accordance with the terms and conditions
set forth herein;
NOW, THEREFORE, in consideration of the above premises and the mutual
covenants hereinafter set forth, the parties hereto agree as follows:
ARTICLE I
DEFINITIONS
1.1 Act shall have the meaning set forth in Section 6.2.
1.2 Active Pharmaceutical Ingredient ("API") shall mean the raw material
components of the Product: [***] and the [***].
1.3 API Reference Standard shall mean a quantity of APIs with a known
assay, supplied by the SEATTLE GENETICS, with which Gensia Sicor may
perform comparative analysis to API samples having an unknown assay.
1.4 API Specifications shall mean the specifications with respect to the
APIs as set forth in the Master Batch Record.
1.5 Affiliate shall mean, with respect to either party, all entities which,
directly or indirectly, are controlled by, control, or are under common
control with such party. For purposes of this definition, the word
"control" shall mean ownership of more than fifty percent (50%) of the
voting shares or interest of an entity.
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1.6 Batch shall mean the entire amount of Product yielded from a
manufacturing event using a specific quantity of APIs, Excipients, and
components Processed in accordance with the Master Batch Record and the
Manufacturing Standards.
1.7 Batch Processing Charge shall mean the pricing set forth in Exhibit B,
as may be adjusted from time to time according to the terms and
conditions set forth herein, which reflects the total cost of a single
Batch manufacture including compounding charges, lyophilization
charges, excipients, components, filters and per unit charges
1.8 Batch Record shall mean the document created as and after each Batch is
Processed and Packaged. Each Batch Record shall reflect and incorporate
all aspects of the Master Batch Record, the applicable Certificate of
Analysis, and any Manufacturing Variance Reports issued with respect to
such Batch.
1.9 Batch Release shall mean the final sign-off by a party's quality
department marking the culmination of the quality process through which
a batch of Product is shown to conform to all aspects of the
Manufacturing Standards.
1.10 Compounded Bulk shall mean the API and Excipients which have been
compounded but not filled or packaged or finished into a final dosage
presentation.
1.11 Certificate of Analysis shall mean a certificate that accompanies each
shipment of APIs or Product certifying that the APIs or Product meets
the specifications as defined in the Manufacturing Standards.
1.12 Current Good Manufacturing Practices or ("cGMPs") shall mean the
current good manufacturing practices and General Biologics Products
Standards as promulgated under the U.S. Federal Food, Drug and Cosmetic
Act ("FDCA") at 21 C.F.R., Chapters 210, 211, 600 and 610, as well as
any other regulations, policies or guidelines, as then in effect, of
the FDA and other United States governmental or regulatory agencies
applicable to the manufacture of sterile pharmaceutical products for
human use.
1.13 Confidential Information shall mean all information, including, where
appropriate and without limitation, any information, patent
disclosures, patent applications, structures, models, techniques,
processes, compositions, compounds and apparatus relating to the same,
disclosed by one party (the "Disclosing Party") to the other party (the
"Recipient") or obtained by Recipient through observation or
examination of such information, but only to the extent that such
information is maintained as confidential by the Disclosing Party.
1.14 Date of Manufacture shall mean the date of sterile filtration and/or
filling of the Compounded Bulk.
1.15 Developments shall have the meaning set forth in Section 2.2.5.
1.16 Disclosing Party shall mean the party from which Confidential
Information is delivered.
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1.17 Equipment shall have the meaning set forth in Section 2.1.1.
1.18 Excipient shall mean any substance other than the API used in
formulating the Compounded Bulk.
1.19 Facility shall mean Gensia Sicor's facility in Irvine, California, or
any other Sicor facility as agreed to in writing, in advance, by the
Parties to this Agreement.
1.20 FDA shall mean the United States Food and Drug Administration and any
successor agencies.
1.21 Forecast shall mean a rolling [***] ([***]) [***] estimate of expected
orders for the Product provided by SEATTLE GENETICS to assist Gensia
Sicor in production planning.
1.22 Gensia Sicor Product Inventions shall have the meaning set forth in
Section 2.2.6.
1.23 IND shall have the meaning set forth in Section 2.5.3.
1.24 Know-How shall mean any technical data, information, material and
knowledge or experience not in the public domain that is necessary or
useful to manufacture the Product.
1.25 Manufacturing Standards shall mean the specifications for Processing,
Packaging, and storing the Product set forth in the Product
Specifications, the Master Batch Record, cGMPs, MSDSs, the Quality
Understanding Document (Exhibit E) and all other applicable U.S. laws
and regulations, to the extent such terms and conditions are not
inconsistent with this Agreement.
1.26 Manufacturing Variance Report shall mean a written report indicating
any Variance in the Processing or Packaging of a Batch from the
procedures set forth in the Master Batch Record.
1.27 Master Batch Record shall mean the document, as may be amended from
time to time, specifying: i) the API Specifications, ii) the procedures
for testing and releasing the APIs, iii) the Excipients, iv) the
Primary Components, v) Secondary Packaging, vi) the Product
Specifications, vii) the formula (listing the APIs and the Excipients
for the Product), and viii) the procedures for manufacturing the
Product (listing the APIs, the Excipients, the Primary Components, and
the Secondary Packaging).
1.28 MSDS shall mean the Material Safety Data Sheets for the APIs and the
Product, respectively.
1.29 NDA shall have the meaning set forth in Section 2.5.3.
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1.30 Notice of Rejection/Nonconformance shall have the meaning set forth in
Section 3.6.1.
1.31 To Package and Packaging shall mean the act of inspecting, labeling,
and packing the Product into units.
1.32 Primary Components shall mean the vial, stopper, and seal as identified
in the Master Batch Record.
1.33 Process or Processing shall mean the pharmaceutical manufacturing
procedures, or any part thereof, involved in manufacturing the Product
in accordance with the Manufacturing Standards.
1.34 Product Specifications shall mean the specifications for the APIs, the
Excipients, the Primary Components, the Secondary Packaging, and the
in-process and release specifications for the Product, as set forth
initially on Exhibit B attached hereto and, subsequently in the Master
Batch Record. Revisions to Product Specifications may be amended by the
Parties from time to time pursuant to Section 2.4., and such changes
shall be reflected in the Master Batch Record.
1.35 Product shall mean the finished dosage form, as set forth in Exhibit A,
and is ready to ship to recipients designated by SEATTLE GENETICS.
1.36 Product Inventions shall have the meaning set forth in Section 2.2.6.
1.37 Purchase Orders shall mean the document provided by SEATTLE GENETICS to
Gensia Sicor which shall set forth, subject to the terms of this
Agreement, the number of Batches or units to be Processed and Packaged,
the estimated Batch Processing Charge, the requested dates and
locations for delivery, and special instructions for each Batch.
1.38 Qualified Supplier shall mean a supplier of materials or components
that has been audited by Gensia Sicor and has passed Gensia Sicor's
quality assurance standards.
1.39 Quality Understanding Document shall mean the statement of quality
understanding defining the roles, responsibilities and interactions
between SEATTLE GENETICS and Gensia Sicor related to the quality of the
Product attached hereto as Exhibit E.
1.40 Recipient shall mean that Party to which Confidential Information is
being delivered.
1.41 SEATTLE GENETICS Information shall have the meaning set forth in
Section 2.2.
1.42 SEATTLE GENETICS Intellectual Property shall have the meaning set forth
in Section 2.2.
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1.43 SEATTLE GENETICS Technology shall have the meaning set forth in Section
2.2.
1.44 Secondary Packaging shall mean any component other than Primary
Components used to convert primary unit(s) into units.
1.45 Shipping Components shall mean the packaging, boxes, and shipping
containers into which the Product is placed for shipment to SEATTLE
GENETICS.
1.46 Term shall have the meaning set forth in Section 5.1.
1.47 Variance shall mean a departure from an established quality standard
(e.g., cGMP standard operating procedure, manufacturing work order,
Packaging order, raw material or Product Specification, analytical
control procedure, water monitoring procedure, equipment maintenance
schedule, or any unusual occurrence), which may be either anticipated
or unanticipated departures from established quality standards and may
have the potential to affect the safety, identity, strength, quality or
purity of the final Product or Compounded Bulk Product.
1.48 Work in Process ("WIP") shall mean the APIs, Excipients, Primary
Components, and Secondary Packaging that constitute a Batch, during the
time period beginning with Gensia Sicor dispensing APIs in accordance
with the Master Batch Record and ending on the SEATTLE GENETICS Batch
Release with respect to such Batch.
ARTICLE II
MANUFACTURE AND PLANNING
2.1 Manufacturing. Gensia Sicor agrees to manufacture Batches of Product
from time to time as agreed to by the Parties, pursuant to this
Agreement. Subject to manufacturing capabilities and capacities, Gensia
Sicor shall provide such facilities, equipment, and services as may be
required to perform the Processing, Packaging and handling of such
Product in accordance with the manufacturing and control procedures set
forth in the Master Batch Record and the Quality Understanding Document
and to the terms and conditions set forth herein.
2.1.1 Equipment. SEATTLE GENETICS shall purchase the items of
equipment set forth in the Engineering Budget Proposal attached
hereto as Exhibit D (the "Equipment") for the prices set forth
therein. At SEATTLE GENETICS' request, Gensia Sicor may purchase
certain of such items for SEATTLE GENETICS' account, and SEATTLE
GENETICS will promptly reimburse Gensia Sicor for the purchase
price thereof. All Equipment shall be installed and used on
Gensia Sicor's premises, but shall be owned by SEATTLE GENETICS.
Gensia Sicor shall maintain the Equipment in good operating
condition and shall keep the Equipment free and clear of all
mortgages, liens and encumbrances. Gensia Sicor will tag all
Equipment and provide SEATTLE GENETICS with a listing of each
item of EQUIPMENT, its location and assigned tag number. Upon
either SEATTLE GENETICS' request or termination of this
Agreement, Gensia
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Sicor shall assist SEATTLE GENETICS, at SEATTLE GENETICS'
expense, in arranging transportation of the Equipment to a
location designated by SEATTLE GENETICS.
2.1.2 Gensia Sicor shall follow cGMP standards to manufacture for
SEATTLE GENETICS, or any third party designated by SEATTLE
GENETICS and agreed to by Gensia Sicor, clinical Batches of an
aseptically filled and lyophilized finished dosage form of the
Product per the Manufacturing Standards, and as may be further
developed by Gensia Sicor, using the APIs, components and
Excipients specified. In accordance with cGMP and during the
term of this Agreement, Gensia Sicor shall utilize validated
cleaning and changeover procedures prior to manufacturing any
Product for SEATTLE GENETICS. Both parties shall promptly notify
each other of any new instructions or specifications required by
cGMP. Upon request, Gensia Sicor shall provide SEATTLE GENETICS
with (a) a written description of any actions taken to comply
with new or revised cGMPs that affect the Product and/or (b)
copies of Gensia Sicor's manufacturing records, including its
Batch Records regarding the Product, for the purposes of
assuring product quality and compliance with agreed-upon
manufacturing procedures.
2.1.3 Gensia Sicor shall adhere to the Product Specifications and
requirements, as detailed in the Master Batch Record, the
Manufacturing Standards and mutually agreed upon protocols,
where such specifications are in compliance and agreement with
FDA and other applicable regulatory agency guidelines. Gensia
Sicor shall obtain SEATTLE GENETICS' prior written approval
before it implements any change in the materials, equipment,
process or procedures used to manufacture the Product that would
constitute a significant deviation under cGMP as described in
the Quality Understanding Document. Gensia Sicor shall disclose
all proposed changes in such manufacturing materials, equipment,
process or procedure to SEATTLE GENETICS at a level sufficient
to allow SEATTLE GENETICS to practice such changed manufacturing
process.
2.1.4 In the event that the Compounded Bulk fails to meet in-process
or release specifications, SEATTLE GENETICS may authorize a
deviation from the Batch Record in an attempt to salvage the
Batch as set forth in Section 3.8(b). Gensia Sicor shall not
rework any Batch of the Product without SEATTLE GENETICS' prior
written consent.
2.1.5 Gensia Sicor declares that it has the production capacity and
the quality systems to fully satisfy SEATTLE GENETICS' requests
for Product and services for clinical needs, provided SEATTLE
GENETICS complies with the forecasting requirements set forth in
Section 2.4.
2.1.6 Gensia Sicor will obtain materials and components for production
from Qualified Suppliers. Upon written request from SEATTLE
GENETICS, Gensia Sicor shall evaluate a supplier that is not a
Qualified Supplier against its current qualification standards.
If such supplier meets Gensia Sicor's standards, such supplier
may become a Qualified Supplier. SEATTLE GENETICS shall
reimburse Gensia Sicor at the rates set forth
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on Exhibit B hereto for all reasonable costs associated with the
qualification of a new supplier.
2.1.7 A Date of Manufacture for each Batch requested to be
manufactured will be provided to SEATTLE GENETICS by Gensia
Sicor upon receipt of a firm Purchase Order, including any
required deposit from SEATTLE GENETICS specified therein, and
acknowledging the terms and conditions detailed in this
Agreement. Gensia Sicor shall schedule the Date of Manufacture
as early as facility availability, staffing resources,
technology transfer, manufacturing scale-up process development,
scheduling capacity and component availability will allow.
2.2 Technology Transfer. SEATTLE GENETICS possesses confidential and
proprietary technical information not in the public domain that is
necessary to the process of manufacturing the Product, including
without limitation in process assays, methods, formulas,
specifications, processes and know-how (the "SEATTLE GENETICS
Information"), that is the subject of various patents, patents
applications and Know-How owned or controlled by SEATTLE GENETICS ("the
"SEATTLE GENETICS Intellectual Property", and collectively with the
SEATTLE GENETICS Information, the "SEATTLE GENETICS Technology").
SEATTLE GENETICS Information shall be included in a technology transfer
dossier to be shared with Gensia Sicor.
2.2.1 Gensia Sicor and SEATTLE GENETICS will mutually develop a Master
Batch Record for the Product following the technical
specifications, methods and know-how provided by SEATTLE
GENETICS.
2.2.2 SEATTLE GENETICS will transfer to Gensia Sicor appropriate
methods and in process assays for manufacturing the Product.
Such methods and in process assays, being reviewed and agreed to
by SEATTLE GENETICS, will be confirmed, or if requested,
validated by Gensia Sicor for their application to the finished
Product.
2.2.3 A protocol describing distribution of Product will be provided
to Gensia Sicor by SEATTLE GENETICS for review and acceptance
prior to commencement of the manufacturing of finished dosage
Product. Distribution of clinical Product will be coordinated
between Gensia Sicor and SEATTLE GENETICS.
2.2.4 SEATTLE GENETICS hereby grants Gensia Sicor a non-exclusive,
non-transferable right under the SEATTLE GENETICS Intellectual
Property to use the SEATTLE GENETICS Information solely for the
purpose of manufacturing the Product pursuant to the terms of
this Agreement. Gensia Sicor (a) acknowledges that SEATTLE
GENETICS and/or its licensors retain all ownership rights in and
to the SEATTLE GENETICS Technology and (b) agrees not to use the
SEATTLE GENETICS Technology for any purpose other than
manufacturing the Product for SEATTLE GENETICS hereunder. Gensia
Sicor agrees to treat all of the SEATTLE GENETICS Technology as
"Confidential Information" pursuant to Article VIII hereof.
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2.2.5 Either party may jointly or independently make or otherwise
acquire rights to non-patentable discoveries, improvements,
ideas and other intellectual property rights (including without
limitation processes and methods) or Know-How useful in the
manufacture of the Product ("Developments"). Any Developments
conceived, fashioned or acquired solely by Gensia Sicor shall be
owned solely by Gensia Sicor. Gensia Sicor shall promptly
disclose all such Developments, in writing, to SEATTLE GENETICS,
and hereby grants to SEATTLE GENETICS a non-exclusive,
worldwide, perpetual, royalty-free license, with the right to
sublicense, to use each such Development for the development and
manufacture of SEATTLE GENETICS' products. Any Developments
conceived, fashioned or acquired solely by SEATTLE GENETICS
during the term of this Agreement shall be owned solely by
SEATTLE GENETICS. Any Developments conceived, fashioned or
acquired jointly by employees of Gensia Sicor and employees of
SEATTLE GENETICS shall be jointly owned by both parties.
2.2.6 The parties do not expect that any patentable inventions,
discoveries, improvements or ideas relating to the manufacture
of the Product ("Product Inventions") will be made, conceived or
reduced to practice during the course of the work performed
under this Agreement. However, any Product Inventions that are
developed or acquired solely by Gensia Sicor shall be owned
solely by Gensia Sicor ("Gensia Sicor Product Inventions").
Gensia Sicor shall not use or incorporate any Gensia Sicor
Product Inventions in the course of the work performed under
this Agreement without first disclosing such Gensia Sicor
Product Inventions to SEATTLE GENETICS and obtaining prior
written approval from SEATTLE GENETICS, upon which the parties
agree to negotiate in good faith the terms of a license
agreement on commercially reasonable terms for such Gensia Sicor
Product Inventions. Any Product Inventions developed or acquired
solely by SEATTLE GENETICS during the term of this Agreement
shall be owned solely by SEATTLE GENETICS. Any Product
Inventions developed or acquired jointly by employees of Gensia
Sicor and employees of SEATTLE GENETICS shall be jointly owned
by both parties. With respect to any filings related to jointly
owned Inventions, the parties shall work together to identify
mutually agreeable intellectual property counsel and shall share
equally in all costs of filing any applications and maintaining
intellectual property protection. Inventorship shall be
determined under U.S. patent law.
2.2.7 During the Term, Gensia Sicor agrees not to [***].
2.3 Audits. Gensia Sicor shall give SEATTLE GENETICS reasonable access to
audit its facilities to provide assurances that Gensia Sicor has
adequate premises, equipment, systems and a staff with sufficient
knowledge and training to carry out satisfactorily the manufacture,
assembly, packaging and testing of the Product. Such audits shall be
scheduled at mutually agreeable times upon at least [***] ([***]) [***]
advance written notice to Gensia Sicor and shall occur no more than one
time per calendar year.
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2.4 Forecasts and Purchase Orders.
2.4.1 SEATTLE GENETICS will provide Gensia Sicor with an updated
rolling [***] Forecast of estimated demand for Product.
Estimated demand for Product shall specify units required and be
communicated in whole Batch increments.
2.4.2 [***] ([***]) days prior to SEATTLE GENETICS' first requested
delivery date, SEATTLE GENETICS shall provide Gensia Sicor with
an initial Forecast accompanied by a firm Purchase Order. On or
before the [***] day of the [***] of each [***] (i.e. [***],
[***], [***] and [***]) during the Term, SEATTLE GENETICS will
provide Gensia Sicor with an update to its previously submitted
Forecast. Unit demand, in the then current and upcoming [***] of
each updated rolling Forecast, shall represent a firm purchase
commitment for the Product. A Purchase Order for SEATTLE
GENETICS' unit requirements during the next [***] shall
accompany each [***] Forecast update. Purchase requirements
during the current [***] shall be reflected in Purchase Orders
previously submitted by SEATTLE GENETICS. Purchase Orders
provided by SEATTLE GENETICS must specify unit quantity,
delivery dates, delivery instructions, anticipated charges and
invoice information.
2.4.3 Gensia Sicor will deliver written confirmation of receipt of
each Purchase Order and the anticipated delivery date of each
Batch of Product to SEATTLE GENETICS within [***] ([***]) [***]
of receipt by Gensia Sicor.
2.4.4 The last [***] ([***]) [***] of each Forecast shall constitute a
good faith estimate of expected orders for the Product to assist
Gensia Sicor with production planning.
2.4.5 The terms and conditions of this Agreement shall govern each
Purchase Order issued hereunder. In the event of conflict, the
terms and conditions of this Agreement shall supercede the
standard terms and conditions of SEATTLE GENETICS' and Gensia
Sicor's forms.
2.5 Product Supply
2.5.1 Gensia Sicor will use commercially reasonable efforts to
accommodate SEATTLE GENETICS' requests for units in excess of
those set forth in the Master Forecast, provided, however, that
no breach of this Agreement shall occur if Gensia Sicor, despite
its commercially reasonable efforts, is unable to supply such
quantities of Product to SEATTLE GENETICS.
2.5.2 Changes to Specifications or Production Process. In the event
that SEATTLE GENETICS proposes any significant change to the
Product Specifications or manufacturing Process, SEATTLE
GENETICS shall deliver written notice to Gensia Sicor describing
such Change. Gensia Sicor shall respond to any such notice
within [***] ([***]) [***] after Gensia Sicor's receipt thereof;
provided, however, that the Product Specifications or Process
shall not be supplemented, modified or amended in any respect
without the prior
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written agreement of the parties hereto. Gensia Sicor will use
commercially reasonable efforts to implement changes. If any
change in the Primary Components, Secondary Packaging, Shipping
Components, Processes or Product testing Specifications
materially increases Gensia Sicor's cost to manufacture, test,
or package the Product, Gensia Sicor reserves the right to make
reasonable pricing adjustments if needed to accommodate such
changes. Prior to initiating any work, Gensia Sicor will provide
a scope of work and cost proposal. New pricing will be effective
upon implementation of the new specifications.
2.5.3 FDA and Regulatory Support. Gensia Sicor shall provide SEATTLE
GENETICS with all documents SEATTLE GENETICS reasonably requests
regarding its manufacturing processes and procedures for the
Product. Gensia Sicor further agrees to use reasonable
commercial efforts to assist SEATTLE GENETICS in obtaining FDA
approval of any Investigational New Drug application ("IND") or
New Drug Application ("NDA") with respect to the Product. Where
practicable and in accordance with the rates set forth on
Exhibit B, Gensia Sicor may assist SEATTLE GENETICS in obtaining
approvals from other government or regulatory agencies which may
be required for the conduct of clinical trials of the Product in
other country(ies). Gensia Sicor specifically agrees to
cooperate with the FDA or other regulatory agencies, including
but not limited to any inspection prior to approval of any IND
or NDA.
2.5.4 Gensia Sicor shall provide SEATTLE GENETICS with samples of the
Product and isolated intermediates for the period of time and in
quantities set forth in the Quality Understanding Document and
any Purchase Orders attached hereto. SEATTLE GENETICS will
provide Gensia Sicor with a sampling protocol, which will be
mutually approved and become part of the Master Batch record.
2.5.5 Documentation. Gensia Sicor shall keep complete, accurate and
authentic accounts, notes, data and records of the work
performed under this Agreement. Each party shall maintain
complete and adequate records pertaining to the methods and
facilities used for the manufacture, processing, testing,
packing, labeling, holding and distribution of the Product in
accordance with the Quality Understanding Document and any
applicable regulations in the United States so that the Product
may be used in humans.
ORDER POSTPONEMENT AND CANCELLATION
2.6 Cancellation or Postponement of Manufacturing. Prior to the Date of
Manufacture as communicated to SEATTLE GENETICS pursuant to Section
2.1.7, SEATTLE GENETICS may cancel or postpone any or all outstanding
Purchase Orders pursuant to this Section 2.6. In the event of
postponement, Gensia Sicor shall use commercially reasonable efforts to
reschedule the postponed order to a date agreeable to both Parties.
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2.6.1 If the Date of Manufacture must be cancelled or postponed by
SEATTLE GENETICS for any reason or due to SEATTLE GENETICS' acts
or omissions, SEATTLE GENETICS may be charged in accordance with
the following:
---------------------------------------------------------------- -------
Postponement Cancellation
------------------------------------------------------------------------
Notice received less than [***] $[***] $[***]
([***]) [***] and more than [***]
([***]) [***] from the scheduled
Date of Manufacture
------------------------------------------------------------------------
Notice received less than [***] $[***] $[***]
([***]) [***] from the scheduled
Date of Manufacture
------------------------------------------------------------------------
2.6.2 SEATTLE GENETICS shall reimburse Gensia Sicor for work already
completed and all non-cancelable commitments incurred by Gensia
Sicor, including without limitation all unique supplies and
components acquired for SEATTLE GENETICS, in the event of
cancellation of any manufacturing run.
2.6.3 If SEATTLE GENETICS does not reschedule the Date of Manufacture
to a date within [***] ([***]) [***] of the originally scheduled
date, the Purchase Order shall be considered cancelled.
2.6.4 SEATTLE GENETICS may postpone a Date of Manufacture [***] before
Gensia Sicor will deem such Batch, and the accompanying Purchase
Order, to be cancelled.
2.7 Shortage of Supply. In the event that Gensia Sicor is unable to meet
requirements to supply the quantity of Product to SEATTLE GENETICS,
Gensia Sicor shall notify SEATTLE GENETICS as promptly as possible.
Gensia Sicor shall implement reasonable commercial measures to remedy
such shortage.
ARTICLE III
SUPPLY AND OWNERSHIP OF MATERIALS
3.1 API Supply. SEATTLE GENETICS, or a supplier designated by SEATTLE
GENETICS, shall supply to Gensia Sicor all APIs and API Reference
Standards necessary to manufacture and test the Product, unless
otherwise mutually agreed. SEATTLE GENETICS shall provide APIs and API
Reference Standards to Gensia Sicor at no charge at least [***] ([***])
[***] prior to any scheduled manufacture of Product. With each delivery
of APIs, SEATTLE GENETICS shall provide to Gensia Sicor a Certificate
of Analysis indicating conformance to the API specifications. In the
event that SEATTLE GENETICS fails to deliver the quantity of conforming
APIs,
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pursuant to this Section 3.1, required for Gensia Sicor to fulfill its
obligations hereunder, then Gensia Sicor shall not be obligated to meet
scheduled delivery dates.
3.1.1 All shipping costs related to the procurement and transfer of
APIs to Gensia Sicor will be the sole responsibility of SEATTLE
GENETICS.
3.2 Labels and Packaging Materials. Primary packaging and labeling units
costs for clinical product are included in the per unit charge set
forth in Exhibit B. Should SEATTLE GENETICS request Gensia Sicor to
design packaging or labeling materials, all costs associated with such
activities shall be invoiced to SEATTLE GENETICS as set forth on
Exhibit B, section III. Labeling and packaging approved by SEATTLE
GENETICS shall be the only such labeling and packaging used by Gensia
Sicor with Product, provided all labels and package inserts shall be
developed in accordance with Gensia Sicor's guidelines with regard to
physical dimensions and handling procedures.
3.3 Excipients and Test Materials. Gensia Sicor shall provide all
Excipients (including, but not limited to, water-for-injection and all
other formulation materials used in the production of Product) and
other manufacturing and test materials, in accordance with the
specifications set forth in the Master Batch Record.
3.4 Gensia Sicor Testing. Gensia Sicor will test the in-process
intermediates of the Product and the final Product per the testing
specifications as set forth on Exhibit C, as may be amended from time
to time upon mutual agreement of the parties, and provide SEATTLE
GENETICS with appropriate documentation. Additional testing requested
by SEATTLE GENETICS and performed by Gensia Sicor shall be invoiced to
SEATTLE GENETICS at a price calculated using the rates set forth in
Exhibit B, attached hereto.
3.5 Quality Understanding.
3.5.1 Quality Understanding Document. As soon as practicable after
execution of this Agreement, the parties will develop and agree
upon the Quality Understanding Document, the format and content
of which is to be agreed upon in writing by the parties, which
will be attached to this Agreement as Exhibit E.
3.5.2 Quality Control Sample. Prior to the delivery of any Batch of
the Product, Gensia Sicor shall provide SEATTLE GENETICS with:
(i) a quality control sample of such Batch for the purpose of
confirming that such Batch meets the Manufacturing Standards;
(ii) a copy of the Batch Record for such Batch, together with
written confirmation that such Batch Record has been reviewed
and approved by Gensia Sicor's Quality Assurance unit; and (iii)
a Certificate of Analysis. The size of the quality control
sample(s) for each Batch of Product shall be specified in the
Master Batch Record. No delivery of any Batch of the Product
shall be made until SEATTLE GENETICS accepts or is deemed to
have accepted the quality control sample(s) and associated
documentation in accordance with the provisions of Section 3.6.
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3.6 Inspection, Rejection of Shipment
3.6.1 SEATTLE GENETICS shall conduct release testing on quality
control samples obtained from each Batch of Product shipped by
Gensia Sicor hereunder to confirm that such quality control
samples conform to the Manufacturing Standards. SEATTLE GENETICS
shall authorize the release of each Batch for shipment by the
later of: (a) [***] ([***]) [***] after SEATTLE GENETICS'
receipt of the quality control samples for such Batch; or (b)
[***] ([***]) [***] after SEATTLE GENETICS' receipt of the Batch
Record for such Batch. If any of SEATTLE GENETICS' internal
assays reveal that a quality control sample does not conform to
the Manufacturing Standards, SEATTLE GENETICS may, in its sole
discretion, by written notice to Gensia Sicor (a "Notice of
Rejection/Nonconformance") either (a) reject the Batch or (b)
initiate an investigation into the reasons for the failure to
conform to the Manufacturing Standards, during which
investigation the time periods set forth in this Section 3.6.1
shall be extended until both parties mutually agree on the cause
of the nonconformance.
3.6.2 SEATTLE GENETICS shall be deemed to have accepted delivery of
Batch of Product if no Notice of Rejection/Nonconformance is
received by Gensia Sicor in accordance with the procedure and
time frame described in Section 3.6.1.
3.6.3 Gensia Sicor shall have the right to sample and retest Product
or to have an outside laboratory sample and retest Product if
SEATTLE GENETICS claims that such Product does not conform to
the Manufacturing Standards. Disputes between the parties as to
whether any Product rejected by SEATTLE GENETICS conforms to the
Manufacturing Standards shall be resolved by a mutually
acceptable third party testing laboratory.
3.6.4 Gensia Sicor shall assume no liability for product that fails to
conform with the Manufacturing Standards if the Product: (i) has
been subjected to misuse, negligence or accident other than by
Gensia Sicor or any employee or agent of Gensia Sicor; (ii) has
been stored, handled or used by others in a manner contrary to
cGMP after delivery to a common carrier; or (iii) nonconformance
is attributable to processes, procedures or Product components
specified by SEATTLE GENETICS in the Master Batch Record where
such processes, procedures or Product components were followed
or used by Gensia Sicor in accordance with the Master Batch
Record.
3.7 Obsolete Components. SEATTLE GENETICS shall reimburse Gensia Sicor for
the actual cost of any obsolete Excipients, Primary Components,
Shipping Components, and Secondary Packaging, (plus any related special
disposal
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costs) purchased by Gensia Sicor expressly to meet its performance
obligations under this Agreement in reliance upon SEATTLE GENETICS'
then most recent Forecast. For the purposes of this Section 3.7, an
obsolete component is any Excipient, Primary Component, Secondary
Packaging, or Shipping Component which cannot be incorporated into the
Product due to changes directed by SEATTLE GENETICS or mandated by a
regulatory authority, or caused by a cancellation or postponement of
manufacturing, and which cannot be reused by Gensia Sicor for another
product manufactured for a third party. Once a Component becomes
obsolete, Gensia Sicor may invoice SEATTLE GENETICS for the acquisition
cost of such obsolete components, which invoice shall identify the
Excipients or Components in question and shall be accompanied by a
reasonably detailed statement of the cause of such obsolescence.
3.8 Risk of Loss. Risk of loss of APIs, in-process and finished Product
held by Gensia Sicor on its premises and in its care, custody and
control, shall be with Gensia Sicor until [***]. Notwithstanding the
foregoing, Gensia Sicor shall not be liable for loss of APIs,
in-process or finished Product when Gensia Sicor is conducting
manufacturing operations in accordance with Gensia Sicor's SOPs, cGMP,
the Manufacturing Standards and the Master Batch Record.
(a) In the event of a failed Batch, Gensia Sicor shall be liable to
SEATTLE GENETICS to the extent that the cause of such a failure
is attributable to the negligence or willful conduct of Gensia
Sicor. In that case, Gensia Sicor shall, as SEATTLE GENETICS's
sole and exclusive remedy for the failed Batch, [***] and
SEATTLE GENETICS may choose, at its sole discretion, one of the
following two options:
Option 1:
Gensia Sicor will pay SEATTLE GENETICS an amount equal to the
[***] of (i) the [***] or (ii) the [***], in each case offset by
the amount, if any, that such failure is attributable to the
negligence or willful conduct of SEATTLE GENETICS.
Option 2:
Gensia Sicor will use commercially reasonable efforts to
remanufacture the Batch as soon as practical, and apply a credit
to the invoice for the replacement Batch in an amount that is
the [***] of (i) the [***] or (ii) the [***], in each case
offset by the amount, if any, that such failure is attributable
to the negligence or willful conduct of SEATTLE GENETICS.
(b) In the event that a batch of Compounded Bulk is found not to
conform with the bulk release specification set forth in the
Manufacturing Standards prior to initiation of the fill, Gensia
Sicor, upon explicit instructions provided by SEATTLE GENETICS,
shall initiate one or more remedial steps in an attempt to bring
the Compounded Bulk into specification. Should these remedial
steps fail to bring the Compounded Bulk into specification
SEATTLE GENETICS may direct GENSIA SICOR to terminate the
manufacturing process at this stage. In the event the
manufacturing process is terminated prior to fill, Gensia Sicor
shall invoice SEATTLE GENETICS for [***] if the [***]. If the
[***] shall be submitted to SEATTLE GENETICS.
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(c) In the event of loss of APIs prior to the start of the
manufacturing process Gensia Sicor shall be liable to SEATTLE
GENETICS [***]. In that case, Gensia Sicor shall, as SEATTLE
GENETICS' sole and exclusive remedy for the lost APIs, pay to
SEATTLE GENETICS an amount that is the [***] of (i) the [***] or
(ii) the [***], in each case offset by the amount, if any, that
such failure is attributable to the negligence of willful
conduct of SEATTLE GENETICS.
3.9 Exceptions. Gensia Sicor shall not be liable for loss of APIs,
formulated bulk, WIP, or Product; (i) resulting from an event of force
majeure pursuant to Section 9.2; (ii) caused by SEATTLE GENETICS'
negligence or willful misconduct; or (iii) occurring while Gensia Sicor
is actually conducting manufacturing operations in accordance with
Gensia Sicor's SOPs, cGMP, the Manufacturing Standards and the Master
Batch Record.
ARTICLE IV
DELIVERY AND PAYMENT TERMS
4.1 Price. The price and delivery terms for Product and services rendered
during the term of this Agreement are set forth in Exhibit B hereto.
4.2 Finished Product Disposition
4.2.1 In accordance with Section 3.6., upon Batch Release by SEATTLE
GENETICS, the Product shall be shipped F.O.B. Gensia Sicor's
plant in Irvine, California in accordance with the instructions
on the applicable Purchase Order and the terms of this
Agreement. A Certificate of Analysis shall accompany each Batch
of Product shipped. In no event shall Gensia Sicor be required
to ship any Batch prior to the SEATTLE GENETICS Batch Release
date.
4.2.2 Delivery of the Product by Gensia Sicor to SEATTLE GENETICS
shall be deemed to have taken place upon delivery at the
Facility to the common carrier designated by SEATTLE GENETICS in
the applicable Purchase Order (or, if none, a common carrier
reasonably selected by Gensia Sicor and approved in writing by
SEATTLE GENETICS). Gensia Sicor will not be liable for loss or
damage to the Product resulting from [***].
4.2.3 All shipping costs related to the distribution of finished
dosage Product to a designated recipient, including but not
limited to all actual freight costs, taxes, duties, import or
export fees, transport fees, shipping documentation, will be the
sole responsibility of SEATTLE GENETICS. Such charges will be
invoiced upon occurrence.
4.3 Shipment Under Quarantine. At SEATTLE GENETICS' discretion and with
Gensia Sicor's consent, SEATTLE GENETICS may authorize a shipment of
Product
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under quarantine. If the Product fails testing, due to the fault of
Gensia Sicor, the cost of shipping the Product back to Gensia Sicor
shall be borne by Gensia Sicor. If the Product fails testing due to the
fault of SEATTLE GENETICS, the cost of shipping the Product back to
Gensia Sicor shall be borne by SEATTLE GENETICS.
4.4 Storage.
4.4.1 Storage of API. At any one time Gensia Sicor will store API, in
quantities not to exceed that sufficient for the manufacture of
two forecasted Batches, at no charge, subject to increase upon
mutual agreement of the parties.
4.4.2 Storage of Finished Product. Gensia Sicor will store the Product
at no charge for up to [***] ([***]) [***] following SEATTLE
GENETICS' Batch Release. In the event that SEATTLE GENETICS
requires a delay in shipment of finished Product and SEATTLE
GENETICS communicates such change in writing prior to Gensia
Sicor Batch Release, Gensia Sicor will either disposition the
Product to a SEATTLE GENETICS specified public pharmaceutical
warehouse or, as space permits, store the finished Product and
invoice SEATTLE GENETICS for the Batch(s). In the event that
Gensia Sicor stores Product for more than [***] ([***]) [***]
following SEATTLE GENETICS Batch Release, Gensia Sicor shall
charge SEATTLE GENETICS according to the rates set forth on
Exhibit B.
4.5 Payment.
4.5.1 Gensia Sicor shall invoice SEATTLE GENETICS upon the later of:
(i) Gensia Sicor's issuance of a Batch Record to SEATTLE
GENETICS with respect to a Batch, or (ii) SEATTLE GENETICS'
acceptance of such Batch. Except as otherwise provided in this
Agreement, all invoices shall be due and payable net [***]
([***]) [***] from the date of the invoice. A late payment
service charge of [***] per month (or the highest amount
permitted by law, if lower than [***]) shall be paid on all
amounts that are past due more than [***] ([***]) [***] from the
date of invoice.
4.5.2 SEATTLE GENETICS shall pay Gensia Sicor the invoiced amount for
Batch Processing Charges of each conforming Batch of Product
pursuant to Exhibit B hereto. In addition, SEATTLE GENETICS
shall pay Gensia Sicor for any other services rendered (as
agreed in advance between the Parties in writing) at the rates
set forth on Exhibit B. Gensia Sicor shall invoice SEATTLE
GENETICS for such tasks and activities promptly after
completion, and such invoices shall be payable [***] ([***])
[***] after the issuance of such invoice.
4.5.3 SEATTLE GENETICS shall make payment to Gensia Sicor in US
dollars only within [***] ([***]) [***] of the date of invoice,
either by check or by wire transfer to the bank account set
forth below, unless otherwise agreed in writing by the Parties.
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` Bank: Bank of America
450 B. Street, Suite 100
San Diego, CA 92101
Routing No.: 121000358
Account Name: Gensia Sicor Pharmaceutical Sales, Inc.
Account No.: 14590-10560
Swift/Sort Code: BofAUS6S
4.6 Taxes. Any federal, state, county or municipal sales or use tax, excise
or similar charge, or other tax assessment (other than that assessed
against Gensia Sicor's revenue or income), assessed or charged on the
contract manufacture of Product pursuant to this Agreement, shall be
paid by SEATTLE GENETICS.
ARTICLE V
TERM
5.1 Term. This Agreement shall commence as of the Effective Date and shall
continue a period of five (5) years from the Effective Date, unless
earlier terminated pursuant to this Article V (the "Term").
5.2 Termination.
5.2.1 Termination for Breach.
This Agreement may be terminated by either party upon [***]
([***]) [***] written notice, if the other party is in material
breach with respect to the performance of any material condition
or obligation under this Agreement and fails to cure such breach
within [***] ([***]) [***] after receipt of notice thereof.
5.2.2 Termination for Bankruptcy.
This Agreement may be terminated by either party, forthwith, or
at any time thereafter by notice to the other if the other
becomes bankrupt or insolvent, or enters into liquidation
whether compulsorily or voluntarily, or convenes a meeting of
its creditors, or has a receiver appointed over all or part of
its assets, or ceases for any reason to carry on business.
5.2.3 Termination for Force Majeure.
This Agreement may be terminated by a party, upon [***] ([***])
[***] written prior notice in the event of the other party's
inability to substantially perform its obligations hereunder for
more than [***] ([***]) [***] due to an event of force majeure
as defined in Section 10.2 herein.
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5.2.4 Termination for [***].
In the event that SEATTLE GENETICS elects to [***] as a result
of [***], SEATTLE GENETICS may terminate this Agreement with
[***] ([***]) [***] written notice to Gensia Sicor, provided
that the [***].
5.3 Accrued Liabilities. Termination of this Agreement for any reason shall
not discharge either party's liability for obligations incurred
hereunder and amounts unpaid at the time of such termination. SEATTLE
GENETICS shall pay Gensia Sicor for any non-cancelable commitments and
Work in Process and Materials (supplied by Gensia Sicor) that were to
be used in the manufacture of Product hereunder and that are in Gensia
Sicor's possession or on order upon termination of the Agreement. All
Materials, Work in Process and finished goods of Product ordered by
SEATTLE GENETICS in Gensia Sicor's possession shall be returned to
SEATTLE GENETICS. In addition, the provisions of Articles I, VII, VIII
and IX and Sections 2.1.1, 2.2.5, 2.2.6, 2.3, 2.5.3, 2.5.5, 5.3, 5.4,
6.3, 6.4, 6.5 and 6.6 shall survive termination or expiration of this
Agreement. Gensia Sicor's obligations to maintain and provide records
and cooperate with SEATTLE GENETICS in connection with quality
assurance and regulatory issues, shall survive the termination or
expiration of this Agreement for a period ending on the earlier of (a)
[***] ([***]) [***] or (b) [***], with such support to be provided to
SEATTLE GENETICS at the labor rates set forth in Exhibit B.
5.4 Property.
5.4.1 In addition to the other obligations of the parties hereunder,
each party shall return to the other party or to the other
party's designee no later than [***] ([***]) [***] after the
effective date of termination all of such other party's
property, including, but not limited to, all proprietary
information, in its possession, except to the extent required to
be retained by law or to comply with such party's continuing
obligations hereunder. In addition, Gensia Sicor shall
reasonably assist SEATTLE GENETICS with respect to transfer or
disposition of Equipment, at the labor rates set forth in
Exhibit B.
5.4.2 All Bulk Active Pharmaceutical Ingredients, Raw Materials,
Components, Containers, and Labeling not necessary to complete
Work In Progress (if such Work in Process has not been duly
canceled by SEATTLE GENETICS) shall, at SEATTLE GENETICS'
option, either be disposed of by Gensia Sicor in accordance with
all applicable federal, state, and local laws and regulations or
returned to SEATTLE GENETICS at SEATTLE GENETICS' expense in
accordance with SEATTLE GENETICS' instructions.
5.5 No Waiver. The failure of either party to terminate this Agreement by
reason of the breach of any of its provisions by the other party shall
not be construed as a waiver of the rights or remedies available for
any subsequent breach of the terms and provisions of this Agreement.
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ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1 Each party hereby represents and warrants to the other party as
follows:
6.1.1 Existence and Power. Such party (a) is duly organized, validly
existing and in good standing under the laws of the state in
which it is organized; (b) has the power and authority and the
legal right to own and operate its property and assets, to lease
the property and assets it operates under lease, and to carry on
its business as it is now being conducted; and (c) is in
compliance with all requirements of applicable law, except to
the extent that any noncompliance would not materially adversely
affect such party's ability to perform its obligations under the
Agreement.
6.1.2 Authorization and Enforcement of Obligations. Such party (a) has
the power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder and
thereunder and (b) has taken all necessary action on its part to
authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such party, and
constitutes a legal, valid, binding obligation, enforceable
against such party in accordance with its terms.
6.1.3 No Consents. All necessary consents, approvals and
authorizations of all governmental authorities and other persons
required to be obtained by such party in connection with the
Agreement have been obtained, except for those which cannot be
obtained prior to the filing of an IND or NDA with respect to
the Product.
6.1.4 No Conflict. The execution and delivery of this Agreement and
the performance of such party's obligations hereunder and
thereunder do not (a) conflict with or violate any requirement
of applicable laws or regulations or any material contractual
obligation of such party and (b) materially conflict with, or
constitute a material default or require any consent under, any
material contractual obligation of such party. Gensia Sicor
shall not in any event enter into any agreement or arrangement
with any other party that would prevent or in any way interfere
with Gensia Sicor's obligations pursuant to this Agreement.
6.2 Adulteration and Misbranding. Gensia Sicor warrants that Product
delivered to SEATTLE GENETICS pursuant to this Agreement shall, at the
time of delivery not be adulterated or misbranded within the meaning of
the Federal Food, Drug and Cosmetic Act, (the "Act") as amended, or
within the meaning of any applicable state or municipal law in which
the definitions of adulteration and misbranding are substantially the
same as those contained in the Act, as the Act and such laws are
constituted and effective at the time of delivery, and will not be an
article which may not, under the provisions of Sections 404 and 505 of
the Act, be introduced into interstate commerce.
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6.3 Conformance to Product Specifications. Gensia Sicor warrants that
Product delivered to SEATTLE GENETICS pursuant to this Agreement shall
conform to the Manufacturing Standards and that such Product shall (i)
be free from defects in material and workmanship, (ii) be manufactured
in accordance with cGMP and all applicable FDA and other rules and
regulations of the United States and (iii) be manufactured in
accordance with Section 3.1 hereof. GENSIA SICOR MAKES NO OTHER
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT. ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE ARE HEREBY DISCLAIMED BY GENSIA SICOR. EXCEPT AS SET FORTH IN
ARTICLE VII, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR INDIRECT,
INCIDENTAL OR COMMERCIAL CONSEQUENTIAL DAMAGES.
6.4 DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
GENSIA SICOR AND SEATTLE GENETICS MAKE NO REPRESENTATIONS AND EXTEND NO
WARRANTIES OF ANY KIND, EITHER EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, INCLUDING BUT NOT LIMITED TO WARRANTIES OF DESIGN,
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A
COURSE OF DEALING OR USAGE OF TRADE PRACTICE.
6.5 Exceptions. The warranties set forth in Sections 6.2 and 6.3 herein
shall not apply to any Product which: (i) has been tampered with or
otherwise altered other than by Gensia Sicor or any employee or agent
of Gensia Sicor; (ii) has been subjected to misuse, negligence or
accident other than by Gensia Sicor or any employee or agent of Gensia
Sicor; (iii) has been stored, handled or used by others in a manner
contrary to current good manufacturing practices or similar
requirements after shipment to SEATTLE GENETICS; or (iv) has expired
its stated shelf life, provided that no more than [***] ([***]) [***]
of the total approved shelf life for each dosage form of Product had
expired upon delivery of such Product to SEATTLE GENETICS.
6.6 Licensing. Gensia Sicor represents and warrants that it has obtained
and will maintain on a current basis and will comply with all licenses,
permits and approvals of applicable governmental agencies as may be
required to manufacture, test and store the Product pursuant to this
Agreement and perform its other obligations hereunder. Gensia Sicor
shall be responsible for obtaining and maintaining licenses and permits
for manufacture, testing and storage of the Product and ensuring that
its facilities used in the manufacture of the Product meet cGMPs in all
respects.
6.7 Compliance with Laws. Gensia Sicor represents and warrants that it
shall comply in all respects with all United States federal, state,
provincial, local and foreign laws, regulations and other requirements
applicable to the manufacture, testing, handling, transportation,
storage and disposal of the Product and the performance of Gensia
Sicor's obligations under this Agreement. Gensia Sicor shall have sole
responsibility for adopting and enforcing safety procedures for the
handling and manufacture of the Product at its facilities and the
proper handling and proper
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disposal of waste relating thereto. SEATTLE GENETICS shall provide
Gensia Sicor with written notice of any additional laws and
regulatory requirements of countries other than the United States
that relate to the manufacture of the Product for such other
countries. Gensia Sicor shall use reasonable commercial efforts to
comply with such additional laws and requirements, and shall
provide SEATTLE GENETICS with prompt written notice of whether
Gensia Sicor is able to do so. All reasonable expenses incurred by
Gensia Sicor to comply with additional laws and regulatory
requirements related to the Product will be borne exclusively by
SEATTLE GENETICS, at the rates set forth in Exhibit B.
ARTICLE VII
INDEMNIFICATION
7.1 By SEATTLE GENETICS. SEATTLE GENETICS shall be solely responsible
for and shall defend, indemnify and hold Gensia Sicor harmless
from and against all damages attributable to personal injury
suffered or incurred by anyone (including any of Gensia Sicor's
employees) and property damages of any third party to the extent
caused by: (i) defects in the Product; (ii) failure by SEATTLE
GENETICS to comply with the Act and the regulations thereunder;
(iii) failure to provide warnings as required by law; (iv) the
handling, transfusion, perfusion, injection or other use of the
Product; (v) any willful act or omission or negligence of SEATTLE
GENETICS or its employees, agents or other contractors in work
performed in the production of the Product, except to the extent
that such claims, suits, losses, damages, costs, fees or expenses
arise or result from breach of Gensia Sicor's warranties hereof or
from any negligent or intentionally wrongful act or omission of
Gensia Sicor.
7.2 By Gensia Sicor. Gensia Sicor shall be solely responsible for and
shall defend, indemnify and hold SEATTLE GENETICS harmless from
and against all damages attributable to personal injuries
suffered or incurred by anyone (including any of SEATTLE GENETICS'
employees) and property damages of any third party to the extent
caused by: (i) a nonconformity of Product with the warranties
under Sections 6.1, 6.2 and 6.3 hereof; (ii) Gensia Sicor's
failure to comply with the Manufacturing Standards; (iii) any
willful act or omission or negligence of Gensia Sicor or its
employees, agents or other contractors in the manufacturing and
testing of the Product; or (iv) failure of Gensia Sicor to comply
with the Act and the regulations thereunder in the production of
Product, except to the extent that such claims, suits, losses,
damages, costs, fees or expenses arise or result from breach of
SEATTLE GENETICS' warranties hereof or from any negligent or
intentionally wrongful act or omission of SEATTLE GENETICS.
7.3 Patent Indemnification. SEATTLE GENETICS shall defend, indemnify
and hold Gensia Sicor and its employees, servants and agents
harmless from and against any and all claims, demands, actions,
suits, losses, damages, costs, expenses (including reasonable
attorney's fees), and liabilities which Gensia Sicor may incur,
suffer or be required to pay by reason of any patent infringement
suit brought against Gensia Sicor because of Gensia Sicor's
manufacture of Product
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to the extent that the alleged infringement arose out of or
related to Gensia Sicor's use of processes, compounds or other
products the rights to which are claimed to be owned by SEATTLE
GENETICS.
7.4 Notice and Assistance. No indemnity under this Article VII shall
be applicable unless the indemnified party gives the indemnifying
party prompt notice of any claim, suit, or action brought against
the indemnified party and allows the indemnifying party to defend
the same (without prejudice to the right of the indemnified party
to participate at its expense through counsel of its own choosing)
and renders the indemnifying party all assistance reasonably
necessary in defending against such claim, suit, or action. No
party shall be required to pay over to another amounts called for
under this Article VII until the final resolution of the claim,
action, suit or proceeding from which the right to such payment
arose.
ARTICLE VIII
CONFIDENTIALITY
8.1 Generally. Each Party acknowledges that the Disclosing Party is in
possession of Confidential Information relating to its products
and technologies and such Confidential Information is the
exclusive and confidential property of the Disclosing Party; and,
except as otherwise expressly set forth herein, the Recipient
shall have no rights or claims to such property. Confidential
Information of the Disclosing Party shall be held in confidence by
the Recipient and not disclosed to any person other than employees
of the Recipient or its Affiliates or contractors or consultants
retained by the Recipient or its Affiliates, in each case who are
bound by duties of confidentiality substantially similar to those
set forth in this Article VIII, except upon prior written consent,
and shall not be used by the Recipient for any purpose except for
development and manufacture of Seattle Genetics' products. The
Receiving Party shall use the strictest standard of care that is
practical to ensure that such employees, contractors and
consultants do not disclose or make any unauthorized use of
Confidential Information. The Receiving Party shall promptly
notify the Disclosing Party upon discovery of any unauthorized use
or disclosure of the Confidential Information. Confidential
Information shall not include, and the obligations of
confidentiality and use shall not apply to, disclosed information
that:
(i) is or becomes publicly available through no fault of
the Recipient or its individual employees, agents or
members amounting to a breach hereof;
(ii) is lawfully obtained on a non-confidential basis by the
Recipient from a third party who is not obligated to
retain such information in confidence
(iii) the Recipient can demonstrate, by competent evidence,
was known to it or any of its Affiliates without a duty
of nondisclosure from a source other than the
Disclosing Party or any of its Affiliates prior to the
disclosure hereunder.
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(iv) the Recipient can demonstrate by its written records is
independently developed by employees of the Recipient
or an Affiliate of the Recipient, which employees were
neither privy to nor had access to the Confidential
Information and which is developed without use in any
way of the Confidential Information
(v) must be disclosed to governmental agencies, provided
that: 1) this exception shall only apply to disclosure
to such agencies, and not to any other person or
entity; and 2) the disclosing Party (a) shall provide
the other Party with prompt notice (including copies of
all written requests or demands) of any proposed
disclosure to any governmental agency, with an
explanation of the Confidential Information of the
other Party to be disclosed; and (b) shall cooperate in
any lawful effort by the other Party to prevent, limit
or restrict disclosure of its Confidential Information
to such government agency.
8.2 Termination. Within [***] ([***]) [***] following the termination
of any agreement between the Parties hereto with respect to the
subject matter Recipient agrees to promptly return all tangible
items relating to the Confidential Information, including all
written material, photographs, models, compounds, compositions and
the like made available or supplied by the Disclosing Party to
Recipient, and all copies thereof, upon the request of the
Disclosing Party. Recipient further agrees to identify those
persons to whom the Confidential Information that is the subject
of this Agreement was disclosed upon request of the Disclosing
Party.
ARTICLE IX
GENERAL PROVISIONS
9.1 Choice of Law. This Agreement shall be governed and interpreted,
and all rights and obligations of the parties shall be determined,
in accordance with the laws of the State of California.
9.2 Force Majeure. Neither Gensia Sicor nor SEATTLE GENETICS shall be
deemed to be in default nor be liable for loss, damage, or delay
in performance, when and to the extent due to causes beyond its
reasonable control or from fire, earthquake, strike, labor
difficulties, insurrection or riot, embargo, utility or power
failure, unforeseen mechanical failure, or any other unforeseeable
cause or causes beyond the reasonable control and without the
fault or negligence of the party so affected, or from defects or
delays in the performance of its suppliers or subcontractors due
to any of the foregoing enumerated causes.
9.3 Notices. All notices, requests, demands, waivers, consents,
approval or other communications to any party hereunder shall be
in writing and shall be deemed to have been duly given if
delivered personally to such party or sent to such party by
telegram or telex or by registered or certified mail, postage
prepaid, to its address as shown below:
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SEATTLE
GENETICS: Seattle Genetics, Inc.
21823 30/th/ Drive SE
Bothell, WA 98102
Attention: Chief Executive Officer
Facsimile: (425) 527-4109
Copy to: Seattle Genetics, Inc.
21823 30/th/ Drive SE
Bothell, WA 98102
Attention: General Counsel
Facsimile: (425) 527-4109
Gensia Sicor: Gensia Sicor Pharmaceutical Sales, Inc.
19 Hughes
Irvine, CA 92618-1902
Attention: Vice President, Business Development
Facsimile: 949/457-2852
Copy to: Gensia Sicor Pharmaceuticals, Inc.
19 Hughes
Irvine, CA 92618-1902
Attention: General Counsel
Facsimile: 949/455-4744
or to such other address as the addressee may have specified in a
notice duly given to the sender as provided herein. Such notice,
request, demand, waiver, consent, approval or other communications
will be deemed to have been given as of the date so delivered,
telegraphed, telexed, or five (5) days after so mailed.
9.4 Severability. In the event that any provision of this Agreement
that is not a material part of the consideration thereof shall be
found in any jurisdiction to be illegal or unenforceable in law
or equity, such finding shall in no event invalidate any other
provision of this Agreement in that jurisdiction, and this
Agreement shall be deemed amended to the minimum extent required
to comply with the law of such jurisdiction.
9.5 Entire Agreement. This Agreement sets forth the entire agreement
reached between the parties hereto with respect to the
transactions contemplated hereby and may not be amended or
modified except by written instrument duly executed by both
parties. Any and all previous agreements and understandings
between the parties regarding the subject matter hereof, whether
written or oral, are superseded by this Agreement. The failure of
either party hereto to enforce at any time, or for any period of
time, any provision of this Agreement shall not be construed as a
waiver of such provision or of the right of such party thereafter
to enforce each and every provision.
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9.6 Assignment, Binding Effect. Neither party shall assign this
Agreement, by operation of law or otherwise, except to an
affiliate of such party, without the prior written consent of the
other party, which consent shall not be unreasonably withheld, and
any such attempted assignment without such consent shall be void;
provided that either party may assign this Agreement without the
other party's consent to a successor entity in connection with a
merger, acquisition or sale of all or substantially all of such
party's assets. No assignment shall be effective until the
assignee shall have unconditionally assumed in writing all of the
assignor's obligations hereunder and a written notice of such
assignment is given to all the other parties. When duly assigned
in accordance with the foregoing, this Agreement shall be binding
upon and inure to the benefit of the assignee.
9.7 Independent Contractor. Each party shall be and shall endeavor to
act as the independent contractor of the other party. Neither
party shall be the legal agent of the other for any purpose
whatsoever and therefore has no right or authority to make or
underwrite any promise, warranty or representation, to execute any
contract or otherwise to assume any obligation or responsibility
in the name of or on behalf of the other party, except to the
extent specifically authorized in writing by the other party.
Neither of the parties hereto shall be bound by or liable to any
third persons for any act or for any obligation or debt incurred
by the other toward such third party, except to the extent
specifically agreed to in writing by the party so to be bound.
9.8 Headings. All section headings contained in this Agreement are for
convenience of reference only, do not form a part of this
Agreement and shall not affect in any way the meaning or
interpretation of this Agreement.
9.9 Other Terms. Parties agree to such other Product specific terms
and conditions as set forth in Exhibits A through E.
9.10 Insurance. Gensia Sicor shall maintain, at its expense, (a) not
less than $[***] of property insurance covering all bulk, finished
or in-process inventory of in-process or finished Product while on
Gensia Sicor's premises or under Gensia Sicor's control and (b)
not less than $[***] of products liability insurance, on an
aggregate and per incident basis. Such property insurance shall be
in the form of an "all risks" policy and shall include earthquake
damage insurance. Gensia Sicor shall name SEATTLE GENETICS as an
additional insured on (a) Gensia Sicor's property insurance policy
and (b) Gensia Sicor's products liability insurance policy, but
only with respect to those claims for which Gensia Sicor is
required to indemnify SEATTLE GENETICS under Article VIII hereof.
Upon, request, Gensia Sicor will provide to SEATTLE GENETICS
certificates of insurance. All insurance required under this
Agreement shall be maintained during the Term, and SEATTLE
GENETICS shall be notified promptly of any cancellation or notice
of cancellation received in connection with such insurance
polices. Notwithstanding the foregoing, Gensia Sicor shall be
obligation to maintain all products liability insurance obtained
by it pursuant to this Section 9.10 during the Term and for a
period of [***] ([***]) [***] following expiration or termination
of this Agreement, and SEATTLE GENETICS shall be notified promptly
of any cancellation or notice of cancellation received in
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connection with such insurance policy. SEATTLE GENETICS shall
maintain, at its expense, not less than $[***] of commercial
general liability insurance, on an aggregate and per incident
basis. SEATTLE GENETICS shall name Gensia Sicor as an additional
insured on SEATTLE GENETICS' commercial general liability
insurance policy, but only with respect to those claims for which
SEATTLE GENETICS is required to indemnify Gensia Sicor under
Article VIII hereof. Upon request, SEATTLE GENETICS will provide
to Gensia Sicor certificates of insurance. All insurance required
under this Agreement shall be maintained during the Term, and
Gensia Sicor shall be notified promptly of any cancellation or
notice of cancellation received in connection with such insurance
polices. Notwithstanding the foregoing, SEATTLE GENETICS shall be
obligation to maintain all commercial general liability insurance
obtained by it pursuant to this Section 9.10 during the Term and
for a period of [***] ([***]) [***] following expiration or
termination of this Agreement, and Gensia Sicor shall be notified
promptly of any cancellation or notice of cancellation received
in connection with such insurance policy.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
SEATTLE GENETICS, INC. GENSIA SICOR PHARMACEUTICALS, INC.
By: /s/ Clay Siegall By: /s/ Armand J. LeBlanc
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Name: Clay B. Siegall Name: Armand J. LeBlanc
Title: President and CSO Title: President
Date: 10-10-02 Date: 10-9-02
GENSIA SICOR PHARMACEUTICAL SALES, INC.
By: /s/ Armand J. LeBlanc
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Name: Armand J. LeBlanc
Title: President
Date: 10-09-02
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