EXHIBIT 10.17
MANUFACTURING AND SUPPLY AGREEMENT
BETWEEN
DENDREON CORPORATION
AND
KIRIN BREWERY CO., LTD.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
ARTICLE 1 DEFINITIONS......................................... 1
1.1 "Affiliate"......................................... 2
1.2 "Back-Up License"................................... 2
1.3 "Business Day"...................................... 2
1.4 "Collaborative License Agreement"................... 2
1.5 "Component" or "Components"......................... 2
1.6 "Controlled"........................................ 2
1.7 "Dendreon Antigen".................................. 2
1.8 "Dendreon Component" or "Dendreon Components"....... 2
1.9 "Dendreon Product".................................. 2
1.10 "Dendreon Technology"............................... 3
1.11 "Dendritic Cell".................................... 3
1.12 "Fully-Burdened Manufacturing Costs"................ 3
1.13 "Information"....................................... 3
1.14 "Kirin Antigen"..................................... 3
1.15 "Kirin Component" or "Kirin Components"............. 3
1.16 "Kirin Product"..................................... 3
1.17 "Licensed Dendreon Product"......................... 3
1.18 "Licensed Kirin Product"............................ 3
1.19 "Manufacturing Know-How"............................ 4
1.20 "Manufacturing Plan"................................ 4
1.21 "Net Revenue"....................................... 4
1.22 "Patent"............................................ 4
1.23 "Product"........................................... 4
1.24 "Purchaser"......................................... 4
1.25 "Reagent"........................................... 4
1.26 "Reasonable Efforts"................................ 4
1.27 "Research and License Agreement".................... 5
1.28 "Regulatory Approval"............................... 5
1.29 "Separation Devices"................................ 5
1.30 "Steering Committee"................................ 5
1.31 "Sublicensee"....................................... 5
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
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1.32 "Supplier".......................................... 5
1.33 "Supplier Patent"................................... 5
1.34 "Third Party"....................................... 5
ARTICLE 2 SUPPLY FOR CLINICAL DEVELOPMENT..................... 5
2.1 Supply for Clinical Development..................... 5
2.2 Forecasts........................................... 6
2.3 Order Placement Procedure........................... 6
2.4 Delivery and Risk of Loss........................... 7
2.5 Acceptance and Rejection............................ 7
2.6 Manufacturing Modifications......................... 8
2.7 Restrictions on Sale................................ 8
2.8 Use of Separation Devices by Kirin Collaborators.... 8
ARTICLE 3 COMMERCIAL SUPPLY................................... 9
3.1 Commercial Supply................................... 9
3.2 Preparation......................................... 9
3.3 Forecasts........................................... 9
3.4 Order Placement Procedure........................... 9
3.5 Inventory........................................... 10
3.6 Amendments.......................................... 10
3.7 Resolution of Supply Problems....................... 11
3.8 Acceptance and Rejection............................ 12
ARTICLE 4 REGULATORY REQUIREMENTS............................. 13
4.1 Manufacturing Facilities, Equipment and Licenses.... 13
4.2 Manufacturing Regulatory Matters.................... 13
4.3 Product Recall Procedures........................... 14
4.4 Documentation....................................... 15
ARTICLE 5 FINANCIAL OBLIGATIONS............................... 15
5.1 Purchase Prices..................................... 15
5.2 Audit............................................... 16
5.3 Financing the Development of Dendreon Products...... 16
ARTICLE 6 CONFIDENTIALITY..................................... 17
6.1 Confidentiality; Exceptions......................... 17
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
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6.2 Authorized Disclosure............................... 17
6.3 Survival............................................ 17
ARTICLE 7 INTELLECTUAL PROPERTY............................... 18
ARTICLE 8 REPRESENTATIONS AND WARRANTIES...................... 18
8.1 General............................................. 18
8.2 Component Warranty.................................. 18
8.3 Warranty Disclaimer................................. 19
ARTICLE 9 TERM AND TERMINATION................................ 19
9.1 Term................................................ 19
9.2 Termination......................................... 19
9.3 Surviving Obligations............................... 19
9.4 Termination Without Cause........................... 19
ARTICLE 10 INDEMNIFICATION..................................... 19
10.1 Indemnification by Dendreon......................... 20
10.2 Indemnification by Kirin............................ 20
10.3 Indemnity Procedure................................. 21
ARTICLE 11 MISCELLANEOUS....................................... 21
11.1 Assignment.......................................... 21
11.2 Retained Rights..................................... 21
11.3 Force Majeure....................................... 21
11.4 Further Actions..................................... 22
11.5 No Trademark Rights................................. 22
11.6 Notices............................................. 22
11.7 Dispute Resolution.................................. 23
11.8 Waiver.............................................. 23
11.9 Severability........................................ 23
11.10 Ambiguities......................................... 23
11.11 Entire Agreement.................................... 23
11.12 Headings............................................ 23
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
iii
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT 10.17
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement (the "Agreement") is made and
entered into effective as of July 27, 1999 (the "Effective Date") by and between
Dendreon Corporation, a Delaware corporation having its principal place of
business at ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇.▇.▇. ("Dendreon"), and Kirin
Brewery Co., Ltd., a corporation organized and existing under the laws of Japan
having its principal place of business at ▇▇-▇, ▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇,
▇▇▇▇▇, ▇▇▇▇▇ ("Kirin"). Dendreon and Kirin may be referred to herein
collectively as the "Parties" or individually as a "Party."
RECITALS
A. Dendreon has developed and owns certain proprietary technology relating
to the manufacture of devices, reagents and proprietary antigens necessary for
Dendreon Products and Kirin Products.
B. Kirin has developed and owns certain proprietary technology relating to
the manufacture of certain proprietary antigens and other proprietary components
necessary for Kirin Products and Dendreon Products.
C. Kirin desires to purchase from Dendreon certain of its devices,
reagents and certain of its proprietary antigens from Dendreon for use in
clinical trials and commercialization of Kirin Products and Licensed Dendreon
Products, and Dendreon is willing to supply Kirin with such devices, reagents
and antigens for such uses.
D. Dendreon desires to purchase from Kirin certain components necessary
for making Licensed Kirin Products for use in clinical trials and
commercialization of Licensed Kirin Products and Dendreon Products, and Kirin is
willing to provide Dendreon with Kirin proprietary antigens and other Kirin
proprietary components and certain Dendreon Components, if applicable, necessary
for Licensed Kirin Products and Dendreon Products for such use.
E. The Parties contemplate that Dendreon may supply Kirin with commercial
quantities of devices, reagents and Dendreon proprietary antigens, and Kirin may
supply Dendreon with commercial quantities of Kirin proprietary antigens and
other Kirin proprietary components, in the event marketing approval is obtained
for any Products, in which case the Parties shall negotiate appropriate
amendments to this Agreement.
F. The Parties contemplate that Dendreon may license Kirin to manufacture
devices, reagents and Dendreon proprietary antigens, and Kirin may license
Dendreon to manufacture Kirin components, necessary for making Products.
Now, therefore, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms shall have the following meanings when used in
this Agreement.
1.1 "Affiliate" means, with respect to a particular Party, a person,
corporation or other entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by or is under common control with such
Party. For the purposes of this definition, "control" means the direct or
indirect ownership by a Party of at least fifty percent (50%) of the outstanding
voting securities of the controlled entity; provided, that in any country where
the law does not permit foreign equity ownership of at least fifty percent
(50%), then with respect to corporations organized under such country's laws,
"control" shall mean the direct or indirect ownership by a Party of outstanding
voting securities of such corporation at the maximum amount permitted by the law
of such country.
1.2 "Back-Up License" shall have the meaning set forth in Section 3.7(c).
1.3 "Business Day" means any day that is not a Saturday, Sunday or other
day on which (a) banks in the State of Washington are authorized or required to
close for the purposes of any action to be taken by or any notice to be provided
to Dendreon, or (b) the banks in Japan are authorized or required to close for
the purposes of any action to be taken by or any notice to be provided to Kirin.
1.4 "Collaborative License Agreement" mean the Agreement by and between
the Parties dated December 10, 1998.
1.5 "Component" or "Components" shall mean either a Kirin Component or a
Dendreon Component, depending upon the context of the applicable Section and the
Party to which such section then applies.
1.6 "Controlled" means, with respect to a particular item, material, or
intellectual property right, that a Party owns or has a license under such item,
material or intellectual property right and has the ability to grant to the
other Party access to and/or a license or sublicense under such item, material
or intellectual property right without violating the terms of any agreement or
other arrangement with, or the rights of, any Third Party.
1.7 "Dendreon Antigen" means an antigen that is claimed by a patent or is
otherwise covered by intellectual property rights that are Controlled by
Dendreon.
1.8 "Dendreon Component" or "Dendreon Components" mean a Separation
Device, Reagent or Dendreon Antigen, or any combination thereof, other than a
combination which comprises a Dendreon Product.
1.9 "Dendreon Product" means: (a) any therapeutic product comprising
Dendritic Cells that have been activated or loaded with a specific antigen,
engineered antigen or antigen gene, (including without limitation Dendreon
Antigen), for use in human therapy by infusion into a patient, which product has
been developed by Dendreon based on the Dendreon Technology; or (b) any service
provided by or on behalf of Dendreon to a patient that utilizes the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Dendreon Technology and involves isolation or preparation of Dendritic Cells,
activation or loading with specific antigen, engineered antigen or antigen gene,
(including without limitation Dendreon Antigen), and infusion of such activated
or antigen loaded Dendritic Cells into a patient. Further, the Parties may agree
in writing to amend and extend the definition of Dendreon Product as provided in
Section 5.8 of the Collaborative License Agreement.
1.10 "Dendreon Technology" means the Dendreon Know-How, the Dendreon
Improvements and the Dendreon Patents, (as such terms are defined in the
Collaborative License Agreement) either collectively or any part thereof.
1.11 "Dendritic Cell" means a human dendritic cell or other antigen-
presenting cell or other cells from which dendritic cells can be derived.
1.12 "Fully-Burdened Manufacturing Costs" means the actual fully burdened
costs and expenses of manufacturing a particular Component, including without
limitation the costs of all raw materials and labor (including all allocable
benefits) used or consumed in such manufacture, Third Party contract
manufacturing costs, packaging costs and expenses, all quality assurance and
quality control related expenses, all overhead amounts allocable to such
manufacturing (including without limitation appropriately amortized capital
equipment costs), all royalty amounts payable by Supplier to any Third Party
based upon the manufacture of such Component, and all amounts related to failed
production units or yield losses, all the foregoing as calculated in accordance
with (i) U.S. generally accepted accounting principles consistently applied for
manufacture of Components by Dendreon and (ii) Japan's generally accepted
accounting principles consistently applied for manufacture of Components by
Kirin.
1.13 "Information" means any and all information and data of any kind,
including without limitation techniques, inventions, practices, methods,
knowledge, know-how, skill, experience, test data (including pharmacological,
toxicological and clinical test data), analytical and quality control data,
marketing, cost, sales and manufacturing data and descriptions, compositions,
and assays.
1.14 "Kirin Antigen" means an antigen that is claimed by a patent or is
otherwise covered by intellectual property rights that are Controlled by Kirin.
1.15 "Kirin Component" or "Kirin Components" shall mean any Kirin Antigen
or any other Kirin proprietary component of a Kirin Product, and any combination
thereof, that Dendreon is either unable to prepare or generally does not prepare
for Kirin or for itself.
1.16 "Kirin Product" means: (a) any therapeutic product developed by or on
behalf of Kirin based on, derived from or incorporating the Dendreon Technology
that comprises Dendritic Cells that have been activated or loaded with a
specific antigen, engineered antigen or antigen gene, (including without
limitation a Kirin Antigen), for use in human therapy by infusion into a
patient; or (b) any service provided by or on behalf of Kirin to a patient that
involves isolation or preparation of Dendritic Cells, activation or loading of a
specific antigen, engineered antigen or antigen gene, (including without
limitation a Kirin Antigen), and infusion of such activated or antigen loaded
Dendritic Cells into a patient, wherein such service is based on, utilizes,
comprises or is derived from the Dendreon Technology. The Parties may agree in
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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writing to amend and extend the definition of Kirin Product as provided in
Section 5.8 of the Collaborative License Agreement.
1.17 "Licensed Dendreon Product" shall have the meaning set forth in
Section 2.3(b) of the Collaborative License Agreement.
1.18 "Licensed Kirin Product" shall have the meaning set forth in Section
2.4(b) of the Collaborative License Agreement.
1.19 "Manufacturing Know-How" means all Information other than Patents
necessary for the manufacture of a Kirin Antigen or Dendreon Antigen which is
subject to the Back-Up License.
1.20 "Manufacturing Plan" shall mean the plan prepared by the Supplier
and delivered to the Purchaser for its review and approval, in good faith, which
plan details the Supplier's manufacturing plan for achieving manufacture of the
Components at levels at least equal to the Purchaser's forecasted orders for the
first year after commercial launch of the first Kirin Product or Dendreon
Product, as applicable.
1.21 "Net Revenue" means the total revenue received by a Party for sale
or other disposition of a Product by such Party or an Affiliate or Sublicensee
of such Party to a Third Party less the following to the extent actually
incurred or allowed with respect to such sale or disposition: (i) reasonable
costs paid, if any, by the Party to a Third Party on account of apheresis
performed as part of or in association with the Product; (ii) discounts,
including cash discounts, or rebates, retroactive price reductions or allowances
actually allowed or granted from the billed amount; (iii) credits or allowances
actually granted upon claims, rejections or returns of Products, including
recalls, regardless of the Party requesting such; (iv) freight, postage,
shipping and insurance charges paid for delivery of Product, to the extent
billed; and (v) taxes, duties or other governmental charges levied on or
measured by the billing amount when included in billing, as adjusted for rebates
and refunds; provided, however, that with respect to sales of a particular Kirin
Product or Licensed Dendreon Product by Kirin or its Affiliate or Sublicensee in
Japan, the "total revenue received", as set forth above in the first line of
this definition, shall not in any event be less than the ▇▇▇ ▇▇▇▇▇ established
for insurance reimbursement of Single Treatment (as defined in the Collaborative
License Agreement), less the average amount charged by the particular hospital
purchaser of such Product for the same number of apheresis services and infusion
services needed for and performed for Single Treatment (as defined in the
Collaborative License Agreement) where such averages are calculated including
all apheresis services or infusion services, as applicable, that were performed
for any purpose during the applicable period.
1.22 "Patent" means (i) a valid and enforceable patent, including any
extension, registration, confirmation, reissue, re-examination or renewal
thereof; and (ii) to the extent valid and enforceable rights are granted by a
governmental authority thereunder, a patent application.
1.23 "Product" means a Kirin Product or a Dendreon Product.
1.24 "Purchaser" shall mean the Party purchasing Components from the
other Party to the Agreement, as applicable, in the applicable section.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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1.25 "Reagent" means, with respect to a particular Licensed Dendreon
Product, any proprietary reagent of Dendreon (excluding any reagents contained
in a Separation Device) that is required for commercial manufacture and/or use
of such Licensed Dendreon Product.
1.26 "Reasonable Efforts" shall mean efforts and resources commonly used
in the research-based pharmaceutical industry for the research, development and
commercialization of a product at a similar stage in its product life taking
into account the establishment of the product in the marketplace, the
competitiveness of the marketplace, the proprietary position of the product, the
regulatory structure involved, the profitability of the product and other
relevant factors.
1.27 "Research and License Agreement" shall mean the Research and License
Agreement by and between the Parties dated as of February 1, 1999.
1.28 "Regulatory Approval" means any approvals, licenses, registrations
or authorizations of any federal, state or local regulatory agency, department,
bureau or other government entity, necessary for the manufacture, use, storage,
import, transport or sale of Products in a regulatory jurisdiction.
1.29 "Separation Devices" means any Dendreon device, including all
containers and proprietary reagents comprising such device, that is intended for
use by Dendreon and its licensees for the isolation and purification of
Dendritic Cells for use in human therapy by activation or loading with specific
antigen, engineered antigen or antigen gene, and infusion into a patient.
1.30 "Steering Committee" shall have the meaning set forth in Section 3.1
of the Collaborative License Agreement.
1.31 "Sublicensee" shall mean any Third Party expressly licensed by a
Party to make and sell one or more Products. A Sublicensee shall not include
distributors or sales agents that do no more than purchase and resell finished
Products on behalf of a Party.
1.32 "Supplier" shall mean the Party supplying Components to the other
Party to the Agreement, its Affiliates or Sublicensees, as applicable, in the
applicable section.
1.33 "Supplier Patent" shall mean any Patent Controlled by the Supplier
during the term of the Agreement.
1.34 "Third Party" means any entity other than Dendreon or Kirin or an
Affiliate of Dendreon or Kirin.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 2
SUPPLY FOR CLINICAL DEVELOPMENT
2.1 Supply for Clinical Development.
(a) Subject to the terms of this Agreement and the Collaborative
License Agreement, Kirin agrees to purchase from Dendreon, and Dendreon agrees
to sell to Kirin, such Separation Devices and Reagents as Kirin requires to
conduct clinical development of Kirin Products and/or Licensed Dendreon Products
in the Kirin Territory.
(b) Subject to the terms of this Agreement and the Collaborative
License Agreement, Kirin agrees to purchase from Dendreon, and Dendreon agrees
to sell to Kirin, such quantities of Dendreon Antigen as Kirin requires to
conduct clinical development of Licensed Dendreon Products in the Kirin
Territory, to the extent such Dendreon Antigen is reasonably available to
Dendreon.
(c) Subject to the terms of this Agreement and the Collaborative
License Agreement, Dendreon agrees to purchase from Kirin, and Kirin agrees to
sell to Dendreon, such quantities of Kirin Components as Dendreon requires to
conduct clinical development of Licensed Kirin products and Dendreon Products in
the Dendreon Territory, to the extent such Kirin Components are reasonably
available to Kirin.
2.2 Forecasts. A reasonable period prior to the first expected order
hereunder by the Purchaser of Components (at least six (6) months if possible),
Purchaser shall provide the Supplier with a good faith written estimate of its
expected requirements, on a per quarter basis, for all such Components for the
first two (2) years after such first order. Commencing three (3) months before
the first expected order, Purchaser shall provide Supplier with quarterly
rolling twelve (12) month forecasts for its expected orders for Components to be
ordered during each quarter during such period, with detail on each specific
Component and quantities to be ordered. An updated forecast will be provided to
Supplier within the first three (3) Business Days of each subsequent calendar
quarter. In each such forecast provided to Supplier as required herein (after
the first such rolling forecast), the forecast for the calendar quarter in which
such forecast is delivered shall constitute a binding commitment of Purchaser
and/or its Affiliates to submit purchase orders for not less than one hundred
percent (100%) of the amounts listed in such forecast during such quarter.
Further, such binding forecast for such quarter may not deviate by more than
twenty-five percent (25%) from the amount forecasted to be ordered during such
quarter in the most recent previous forecast provided to Supplier.
2.3 Order Placement Procedure. The Purchaser shall place orders for
Components to be supplied under the Agreement on Purchaser's standard English-
language purchase order form, specifying the quantity of each type of Component
ordered and the requested delivery date, which shall not in any event be longer
than one hundred and twenty (120) days from the date of such purchase order;
provided, however, that if due to complications and lead time for a particular
Component (such as antigen) the Supplier of such Component requires a delivery
lead time for manufacture of such Component greater than one hundred twenty days
(120) from the date of such purchase order, the Parties shall negotiate in good
faith a reasonable delivery date for such Component, not to be greater than one
hundred and eighty (180) days from the date of
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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the purchase order. Supplier shall not be obligated to deliver Components
ordered prior to sixty (60) days after the applicable order is placed; however,
Supplier agrees that it will use Reasonable Efforts to meet any earlier delivery
date reasonably requested by Purchaser. To the extent any purchase order,
invoice or acknowledgment form used by Supplier or Purchaser contains any
provisions additional or contrary to the provisions of this Agreement, such
additional or contrary provision shall have no force or effect and the terms of
this Agreement shall control. In addition, all such orders shall comply with the
other requirements of this Article 2. The total amount of Components ordered by
Purchaser during a particular calendar quarter shall not in any event be less
than one hundred percent (100%) of the amount of each such Component that was
forecasted to be ordered for such quarter in the most recent forecast provided
to Supplier, as set forth in Section 2.2 above, unless Supplier otherwise agrees
in writing. In addition, Supplier shall not be obligated to supply any amounts
in such order that are in excess of one hundred ten percent (110%) of the amount
of the particular Component that was forecasted in the most recent binding
forecast to be ordered for such quarter; however, Supplier agrees that it will
use Reasonable Efforts to supply such additional amounts. The Supplier shall use
Reasonable Efforts to deliver the Components ordered in compliance with this
Article 2. The Supplier shall immediately notify Purchaser in writing if
Supplier determines that Supplier will not be able to supply a material amount
of the most recent orders and/or forecasts of orders for any Component. Shipment
and delivery of Components ordered hereunder shall be in accordance with Section
2.4.
2.4 Delivery and Risk of Loss.
(a) Delivery of Dendreon Components ordered hereunder by Kirin shall
be by FCA Dendreon's actual manufacturing facility for such Components. "FCA"
shall be construed in accordance with INCOTERMS 1990 of the International
Chamber of Commerce. At Kirin's request and cost, Dendreon shall arrange
shipping to specified Kirin locations. Delivered Dendreon Components shall be
appropriately packaged by Dendreon, at Dendreon's expense, for export shipment.
(b) Delivery of Kirin Components (and any Dendreon Components, if
applicable) ordered hereunder by Dendreon shall be by FCA Kirin's actual
manufacturing facility for such Components. "FCA" shall be construed in
accordance with INCOTERMS 1990 of the International Chamber of Commerce. At
Dendreon's request and cost, Kirin shall arrange shipping to specified Dendreon
locations. Delivered Kirin Components shall be appropriately packaged by Kirin,
at Kirin's expense, for export shipment.
2.5 Acceptance and Rejection. Purchaser shall have the right to test at
its expense, using testing procedures agreed upon by the Parties and set forth
in the specifications for the applicable Component, a portion of each shipment
of Components to confirm that such shipment meets the applicable specifications.
Where it is required by local regulations, further testing on importation in
accordance with the applicable specifications shall be carried out by Purchaser.
If Purchaser rejects in whole or in part any nonconforming shipment of
Components, Purchaser shall provide Supplier written notice of such rejection no
later than thirty (30) days after receipt of such shipment of Components. If
Purchaser fails to provide Supplier with such notice of rejection within such
thirty (30) day inspection period, Purchaser shall be deemed to have accepted
the applicable shipment of Components. If Supplier agrees with Purchaser's
determination that a shipment of Components does not comply with applicable
specifications,
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7
Supplier shall use Reasonable Efforts to replace the nonconforming Components,
at no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's
conclusion that such Components do not meet the applicable specifications,
Supplier shall use Reasonable Efforts to replace such shipment of Components to
Purchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's
determination that the rejected shipment did not meet the applicable
specifications, a sample of the rejected shipment shall be submitted to an
independent, qualified Third Party laboratory that is mutually acceptable and
selected by the Parties promptly in good faith. Such laboratory shall determine
whether the rejected Components meet the applicable specifications, and such
laboratory's determination shall be final and determinative for purposes of this
Agreement. The Party against whom the laboratory rules shall bear all costs of
the laboratory testing. If the laboratory rules that the shipment of Components
failed to meet the applicable specifications, then at Purchaser's choice, the
price paid by Purchaser for such nonconforming shipment shall be reimbursed to
Purchaser (provided Purchaser paid for such shipment) or Components meeting the
applicable specifications shall be shipped. If the laboratory rules that the
Components do not meet the applicable specifications, and if Supplier is unable
to produce conforming Components, any sums actually paid therefore shall be
refunded to Purchaser with interest. At such time, the Parties will discuss in
good faith potential solutions to the supply problem. If the laboratory rules
the rejected shipment of Components met the applicable specifications, then
Purchaser shall accept such shipment (including all costs of shipping and
insurance). Shipments of Components not meeting the applicable specifications
may, at Supplier's option and expense, be returned to Supplier or destroyed by
Purchaser. If Supplier has acknowledged in writing that it is unable to produce
conforming Components, any sums actually paid therefor will be refunded. The
remedy of replacement or refund is available only if such nonconformance was not
caused by Purchaser's misuse, unauthorized modifications, neglect, improper
testing or improper storage, including without limitation storage at
inappropriate temperatures, of such shipment of Components.
2.6 Manufacturing Modifications. If the laws of a country require
Supplier's established specifications for a particular Component or Components
to be modified in order for Purchaser to obtain Regulatory Approval of a Product
in such country, Purchaser will submit the matter to the Steering Committee for
discussion and proposed resolution. The Parties agree to negotiate in good faith
any proposed modifications to the specifications for such Component or
Components for such Products proposed by the Steering Committee. Any such
resolution of the Steering Committee must be agreed in writing by the Parties.
2.7 Restrictions on Sale. Kirin and its Affiliates shall not resell the
Separation Devices purchased pursuant to this Article 2 except as part of a
Kirin Product or a Licensed Dendreon Product, and shall not use Separation
Devices, Reagents or Dendreon Antigen for any purpose other than those purposes
permitted in this Agreement, the Collaborative License Agreement or the Research
and License Agreement. Dendreon shall retain all rights to manufacture or have
manufactured the Separation Devices, Reagents and Dendreon Antigens. Dendreon
and its Affiliates shall not use Kirin Antigen for any purpose other than those
purposes permitted in this Agreement, the Collaborative License Agreement or the
Research and License Agreement.
2.8 Use of Separation Devices by Kirin Collaborators. With Dendreon's
prior written approval, which may be withheld for any reason, Kirin may provide
certain academic or medical doctor collaborators with a limited number of
Separation Devices solely for use by such
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individuals in research and development purposes in the Field; provided,
however, that before any such delivery Kirin shall require such collaborator:
(i) to be appropriately trained in the use of the Separation Devices, (ii) to
share the results of any and all research and development performed using the
Separation Devices with Kirin and Dendreon; (iii) not to sell, distribute or
otherwise provide such Separation Devices to Third Parties; and (iv) unless such
antigen is within the public domain, to grant Dendreon an option to license any
specific antigen, engineered antigen or antigen gene used or developed in
conjunction with the use of the Separation Devices. Except as explicitly
provided in this Agreement, Kirin obtains no license or rights to make or to
practice any of the Dendreon Technology to make Separation Devices, Reagents or
any other devices or products for use in the isolation or purification of
Dendritic Cells or any other cells. Notwithstanding anything else in this
Agreement, Kirin may use Separation Devices to isolate Dendritic Cells only as
part of preparing a Kirin Product or Licensed Dendreon Product or performing a
service comprising a Kirin Product or Licensed Dendreon Product, or with
Dendreon's prior written consent, as provided in this Section 2.8.
ARTICLE 3
COMMERCIAL SUPPLY
3.1 Commercial Supply. Subject to the other terms of this Agreement,
Dendreon agrees to provide Kirin, its Affiliates and Sublicensees with their
commercial requirements of Separation Devices, Reagents and Dendreon Antigens
necessary for use in manufacturing or using Kirin Products or Licensed Dendreon
Products for which Regulatory Approval has been obtained in the Kirin Territory.
3.2 Preparation. At such time after the Effective Date that Supplier has
prepared the Manufacturing Plan, but no later than one hundred and twenty (120)
days before the commercial launch of the first Kirin Product or Dendreon
Product, as applicable, Supplier shall provide to Purchaser such Information in
Supplier's control relating to lead times Supplier requires to achieve
manufacture of Components on a commercial scale hereunder, necessary to
determine appropriate procedures and mechanisms for providing to Supplier
forecasts of Purchaser's, its Affiliates' and Sublicensees' requirements for
Components to be ordered and purchased hereunder, and for ordering such
requirements. The Purchaser shall review such Information promptly after
receipt, and appropriate representatives from Purchaser and Supplier shall then
meet to determine the appropriate forecasting, ordering and inventory mechanisms
that will be used by the Parties for ordering and supplying the commercial
requirements of Components hereunder. Such forecasting, ordering and inventory
mechanisms shall be consistent with the terms of this Article 3 and shall be set
forth in a writing, and upon mutual execution of such writing by the Parties,
such mechanisms (the "Supply Procedures") shall become part of this Agreement.
3.3 Forecasts. With respect to the forecasting mechanism, such Supply
Procedures shall provide: (a) that within an agreed period of time prior to the
first expected Regulatory Approval of a Product, Purchaser shall provide a good
faith estimate of its expected requirements, on a per quarter basis, for each
particular Component which is part of such Product to be ordered, for an agreed
period before and an agreed period after the launch of such Product; (b) as of
an agreed time before the first expected Regulatory Approval of a particular
Product, Purchaser shall provide Supplier a rolling twelve (12) month forecast
for Purchaser's expected
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orders for each particular Component during each month during such twelve (12)
month period; (c) Purchaser shall provide Supplier updated forecasts for
expected orders of Components at agreed intervals of time; (d) that in each
forecast provided, the forecasted orders for an agreed time period for each
forecasted Component shall constitute binding orders by Purchaser for such
Components, to be placed during such agreed time period; and (e) that forecasted
orders for each Component in a particular forecast delivered to Supplier may not
deviate by more than twenty-five percent (25%) from the forecast for orders for
such Components in the most recent previous forecast submitted to Supplier. The
Parties further agree that if a Party determines that the foregoing forecasting
mechanisms are inappropriate given the then-existing manufacturing and supply
circumstances for any Component, the Parties will discuss and agree in good
faith on appropriate written amendments to the forecasting mechanisms for such
Component.
3.4 Order Placement Procedure. With respect to the ordering mechanism,
such Supply Procedures shall provide: (a) that Purchaser shall place orders for
Components to be supplied under the Agreement on Purchaser's standard purchase
order form, specifying the quantity of each specific Component ordered and the
requested delivery date, which shall not in any event be sooner or later than
agreed time period(s) from the date of such purchase order; (b) that to the
extent any purchase order, invoice or acknowledgment form used by Purchaser
contains any provisions additional or contrary to the provisions of this
Agreement, such additional or contrary provision shall have no force or effect
and the terms of this Agreement shall control; (c) that Supplier shall not be
obligated to supply any amounts of a particular Component in such order more
than an agreed percentage of the unit quantity of such Component specified in
the binding forecast for the applicable time period; (d) that Purchaser's orders
for a Component may not be less than an agreed percentage of the binding
forecast for such Component for the applicable time period; and (e) that
Supplier will use Reasonable Efforts to provide additional amounts of a
particular Component beyond the foregoing limitation on Supplier's obligation to
supply, upon Purchaser's reasonable request, but consistent with Supplier's
other business obligations.
3.5 Inventory. The Supply Procedures shall also establish an inventory
mechanism for Components, which shall provide that: (a) within an agreed period
of time after the commercial launch of a particular Product, Supplier shall use
Reasonable Efforts to maintain an inventory of the Components in such Product at
least equal to the written forecast for purchases of such Product to be made
during an agreed number of months in the most recent forecast provided to
Supplier by Purchaser under the forecasting mechanism of the Supply Procedures;
(b) Purchaser shall maintain an inventory of all Components in accordance with
Purchaser's normal practices, and shall give Supplier quarterly updates of the
extent of such inventory; (c) Supplier's inventory of Components maintained
under such inventory mechanism shall only be permitted to fall below the levels
established in subsection (a) above in the event that Purchaser submits orders
in excess of the forecasted amounts or Supplier experiences manufacturing or
supply problems with respect to the Components; and (d) Supplier shall use
Reasonable Efforts in accordance with Supplier's normal practices to promptly
replenish any inventory of Components that is depleted in satisfying purchases
of such Component by Purchaser hereunder.
3.6 Amendments. The Parties further agree that if the foregoing
forecasting, ordering or inventory mechanisms established in the Supply
Procedures are determined by the Parties, in good faith cooperation and giving
reasonable consideration to each Party's economic and business needs, to be
inappropriate given the experience of the Parties and the then-existing
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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manufacturing and supply circumstances regarding Components hereunder, the
Parties will discuss in good faith appropriate amendments to the applicable
mechanisms in the Supply Procedures.
3.7 Resolution of Supply Problems.
(a) If Supplier determines that Supplier will not be able to supply to
Purchaser a material amount of the most recent orders and/or binding forecasts
of orders for a particular Component submitted by Purchaser in accordance with
the applicable Supply Procedures, Supplier shall immediately notify Purchaser in
writing of such determination, which notice shall provide Purchaser with the
details on the extent of the expected shortfall of supply, the causes of such
inability to supply, and Supplier's proposed solution to the problem. Upon such
notice of a supply problem, or in any event upon Supplier's failure to satisfy,
within the delivery time frame specified by Purchaser consistent with the Supply
Procedures, a portion of the Components ordered by Purchaser in compliance with
this Agreement, (provided that such supply problem or failure cannot be
satisfied or addressed by Purchaser's and Supplier's existing inventories for
such Components and will cause an interruption in the supply of such Components
by Purchaser or its Affiliates to the commercial market for more than thirty
(30) days), Purchaser and Supplier will immediately meet and work together, in
good faith, to identify an appropriate resolution to the supply problem. The
Parties will discuss all appropriate means of resolving the problem, including
without limitation establishing an alternative source of supply for the affected
Components, creating a back-up manufacturing facility, or permitting Purchaser
to manufacture an agreed amount of Components to cover the shortfall in supply,
with Supplier continuing to supply an agreed amount of such Components. Any
agreed resolution to the supply problem will be set forth in a writing executed
by both Parties.
(b) If the Parties cannot reach agreement on an appropriate resolution
to the supply problem within ten (10) days of commencing such discussions under
subsection (a) above, senior management representatives of the Parties will
immediately meet to discuss in good faith the problem in an effort to reach
agreement on such resolution. As part of such discussions, Supplier shall make a
firm commitment of the amount of the affected Components that Supplier will be
able to supply, on a monthly basis, during the period when such supply problem
with respect to such Components is expected to continue. Any agreed resolution
by the Parties to the supply problem will be set forth in a writing executed by
both Parties. If, despite good faith efforts, the senior management officials
are unable to reach agreement on the resolution of such supply problem within
twenty (20) days of their commencing such discussions, then at either Party's
immediate written request, the problem will be governed by the terms of Section
11.7 if it affects Components other than Kirin Antigen or Dendreon Antigen, and
by the terms of Section 3.7(c) if it affects Kirin Antigen or Dendreon Antigen.
(c) If there is a material supply problem with respect to Kirin
Antigen or Dendreon Antigen subject to the provisions of subsections 3.7(a) and
(b) above, and (i) the Parties have failed to reach agreement on the resolution
of such problem within the time frames set forth above by the end of the twenty
(20) day period as provided under subsection (b), or (ii) Supplier has failed to
meet to discuss the problems as required above, then at Purchaser's written
request provided to Supplier no more than sixty (60) days after the foregoing
conditions have been met, Supplier shall grant to Purchaser a co-exclusive
license as to Kirin Antigen or Dendreon Antigen, as applicable, (the "Back-Up
License"), under the relevant Supplier Patents
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and Manufacturing Know-how, as necessary to permit Purchaser to make or have
made such Kirin Antigen or Dendreon Antigen that is the subject of such supply
problem that was not resolved by the Parties, solely for sale in accordance with
the terms of this Agreement, the Collaborative License Agreement and the
Research and License Agreement, and solely in quantities to meet the amounts of
Purchaser's and its Affiliates' and sublicensees' (if any), and Supplier's and
its Affiliates' and sublicensees' (if any), if applicable, requirements for such
Kirin Antigen or Dendreon Antigen above the amounts of such Kirin Antigen or
Dendreon Antigen that Supplier remains able and willing to supply on a timely
basis under this Article 3. Purchaser covenants, represents and warrants that
Purchaser shall not exercise the Back-Up License unless and until the conditions
specified in the first sentence of this Section 3.7(c) have been completely
satisfied and shall not use or practice the licensed Supplier Patents and
Manufacturing Know-how for any purpose except as expressly permitted in the
foregoing. Immediately upon Purchaser's written request hereunder to obtain the
Back-Up License, Supplier shall transfer to Purchaser copies of all information,
including technical information, that is Controlled by Supplier, relates to the
manufacture of the Kirin Antigen or Dendreon Antigen that is the subject of the
Back-Up License and is reasonably necessary to enable Purchaser to manufacture
such Kirin Antigen or Dendreon Antigen. Thereafter, but only during the period
when Purchaser is permitted hereunder to exercise the Back-Up License, Purchaser
shall be permitted access to and a right of reference to any Regulatory
Approvals held in Supplier's name for the Kirin Antigen or Dendreon Antigen that
is the subject of such Back-Up License. Supplier shall provide Purchaser
reasonable assistance, at Purchaser's request and Purchaser's expense, with
respect to understanding such manufacturing information and practicing the Back-
Up License.
(i) At such time as Supplier is reasonably able to meet all of
Purchaser's forecasted orders for Kirin Antigen or Dendreon Antigen, as
applicable, the Back-Up License granted under this Section 3.7(c) shall
terminate with respect to such Kirin Antigen or Dendreon Antigen, and Purchaser
shall immediately cease to exercise and practice the Back-Up License, provided
that Purchaser shall retain all rights under this Section 3.7 with respect to
any subsequent supply problem as to any Kirin Antigen or Dendreon Antigen, as
applicable.
(ii) Purchaser will pay Supplier a royalty of [ * ] of the Net
Revenue of Kirin Products or Dendreon Products (as applicable) manufactured by
or on behalf of Purchaser pursuant to exercise of the Back-Up License and sold
by Purchaser or its Affiliate or sublicensee. Nothing in the foregoing shall
limit or affect in any way Purchaser's obligations to make the payments set
forth in this Agreement to the full extent required on all Components supplied
to Purchaser by Supplier.
3.8 Acceptance and Rejection. Purchaser shall have the right to test at
its expense, using testing procedures agreed upon by the Parties and set forth
in the specifications for the applicable Component, a portion of each shipment
of Components to confirm that such shipment meets the applicable specifications.
Where it is required by local regulations, further testing on importation in
accordance with the applicable specifications shall be carried out by Purchaser.
If Purchaser rejects in whole or in part any nonconforming shipment of
Components, Purchaser shall immediately provide Supplier written notice of such
rejection. If Supplier agrees with Purchaser's determination that a shipment of
Components does not comply with applicable specifications, Supplier shall use
Reasonable
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Efforts to replace the nonconforming Components, at no additional cost to
Purchaser. If Supplier reasonably disputes Purchaser's conclusion that such
Components do not meet the applicable specifications, Supplier shall use
Reasonable Efforts to replace such shipment of Components to Purchaser, at
Purchaser's expense. If Supplier disagrees with Purchaser's determination that
the rejected shipment did not meet the applicable specifications, a sample of
the rejected shipment shall be submitted to an independent, qualified Third
Party laboratory that is mutually acceptable and selected by the Parties
promptly in good faith. Such laboratory shall determine whether the rejected
Components (as applicable) meet the applicable specifications, and such
laboratory's determination shall be final and determinative for purposes of this
Agreement. The Party against whom the laboratory rules shall bear all costs of
the laboratory testing. If the laboratory rules that the shipment of Components
failed to meet the applicable specifications, at Purchaser's choice, the price
paid by Purchaser for such nonconforming shipment shall be reimbursed to
Purchaser (provided Purchaser paid for such shipment) or Components meeting the
applicable specifications shall be shipped to Purchaser by Supplier. If the
laboratory rules the rejected shipment of Components met the applicable
specifications, then Purchaser shall accept such shipment (including all costs
of shipping and insurance). Shipments of Components not meeting the applicable
specifications may, at Supplier's option and expense, be returned to Supplier or
destroyed by Purchaser. If Supplier has acknowledged in writing that it is
unable to produce conforming Components, any sums actually paid therefor will be
refunded with interest, and the supply problem will be resolved in accordance
with Section 3.7. The remedy of replacement or refund is available only if such
nonconformance was not caused by Purchaser's misuse, unauthorized modifications,
neglect, improper testing or improper storage, including without limitation
storage at inappropriate temperatures, of such shipment of Components.
3.9 Kirin Manufacture of Dendreon Components. Kirin agrees to provide
Dendreon, its Affiliates and Sublicensees with their commercial requirements of
Kirin Components necessary for Licensed Kirin Products for which Regulatory
Approval has been obtained, pursuant to the terms of this Article 3. In
addition, if so requested by Dendreon, Kirin may negotiate with Dendreon for the
manufacture and supply by Kirin to Dendreon of certain Separation Devices,
Reagents and/or Dendreon Antigens at a transfer price in an amount in U.S.
dollars equal to Kirin's Fully-Burdened Manufacturing Costs for such Separation
Devices, Reagents and/or Dendreon Antigens plus a handling fee of [ * ], with
any manufacture and supply to be governed by the terms of this Agreement and any
additional terms negotiated by the Parties. The Parties also agree to amend the
terms of the Agreement to reflect such agreed terms for the manufacture and
supply by Kirin of Separation Devices, Reagents and/or Dendreon Antigens, if
any.
ARTICLE 4
REGULATORY REQUIREMENTS
4.1 Manufacturing Facilities, Equipment and Licenses. Supplier shall, at
Supplier's expense, acquire or cause to be acquired all equipment and licenses,
including, without limitation, all necessary plant equipment and facilities
licenses, necessary to enable the manufacture and testing of the Components as
required hereunder. Supplier shall obtain and maintain all necessary Regulatory
Approvals. Purchaser, its Affiliates and Sublicensees shall obtain any required
importation licenses or approvals for importation of Dendreon Products and Kirin
Products, and the Components necessary for such Kirin Products and Dendreon
Products, as applicable for sale in any given country. Supplier shall cooperate
reasonably with Purchaser, at Purchaser's reasonable request and expense, to
obtain such licenses or approvals.
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4.2 Manufacturing Regulatory Matters.
(a) Supplier will be responsible for any reporting of matters
regarding the manufacture of Components, as applicable, to the FDA and other
relevant regulatory authorities, in accordance with pertinent laws and
regulations. Supplier shall notify Purchaser of any such matter if significant
or serious and promptly furnish complete copies of such reports to Purchaser in
the English language. Supplier also shall advise Purchaser of any occurrence or
information which arises out of Supplier's manufacturing activities which has
adverse regulatory compliance and/or reporting consequences concerning a
Component.
(b) Supplier shall be responsible for handling and responding to any
appropriate governmental agency inspections with respect to manufacturing of
Components during the term of this Agreement. Supplier shall provide to
Purchaser any information requested by any governmental agency in connection
with any governmental inspection related to Components. Supplier shall use
reasonable efforts to promptly advise Purchaser of any requests by any
governmental agency for such inspections with respect to manufacturing of
Components.
(c) Any changes by Supplier to the manufacturing process for
Components that may require approval by the FDA or other authorities or
amendment of existing Regulatory Approvals shall require the prior written
approval of Purchaser, not to be unreasonably withheld or delayed.
(d) Supplier certifies it did not and will not use in any capacity
the services of any person, including any firm or individual, debarred or
subject to debarment under the Generic Drug Enforcement Act of 1992, amending
the Food Drug and Cosmetic Act at 21 USC 335a. Supplier agrees to notify
Purchaser immediately in the event any person providing services to Supplier
under the scope of the work of this Agreement is debarred or becomes subject to
debarment.
(e) For the limited purpose of permitting a quality and compliance
audit, Supplier shall grant to authorized representatives of Purchaser upon
reasonable notice and not more than once per year, unless a substantial and
reasonable need for an additional audit can be shown, access to areas of
Supplier's plants and each of Supplier's Third Party supply contractor's plants,
and to those technical records made by Supplier that only relate solely to
Quality Assurance testing and regulatory compliance monitoring for manufacturing
of Components, at such times as Components are being manufactured, solely for
the purpose of Purchaser determining that such manufacture is in compliance with
regulatory requirements. Purchaser shall provide Supplier at least thirty (30)
Business Days notice in writing of its desire to have such access. Supplier
shall promptly respond to Purchaser's request and the Parties shall agree on the
time of and procedures for the audit. All such inspections shall be subject to
confidentiality obligations.
4.3 Product Recall Procedures. The Parties shall immediately inform each
other in writing of all Information relating to: (a) any incident relating to a
Product and/or any Product or Component that is the subject of recall, market
withdrawal or correction; or (b) any Components that may require, whether based
on manufacturing defect, tampering, or otherwise, a recall, field alert, product
withdrawal or field correction arising from any defect in any such Component
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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provided under this Agreement. The Parties then shall meet and discuss the
situation in good faith to determine if a recall, field alert, product
withdrawal, or field correction is necessary. In the event that either
Purchaser or Supplier decides that a recall, field alert, product withdrawal, or
field correction is necessary due to any defect or other problem in any
Component, the Parties shall cooperate and use Reasonable Efforts in effecting
any such required recall, market withdrawal or correction. Payment of costs and
expenses associated with recalls, market withdrawals, market corrections and the
costs associated with replacement of the recalled or withdrawn Products or
Components shall be borne by the Party whose negligent or defective
manufacturing, processing, testing, packing or storage necessitated such recall,
market withdrawal or market correction.
4.4 Documentation. Supplier 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 by it for the manufacture, processing, testing,
packing, labeling, holding and distribution of Components in accordance with the
applicable regulations in the United States and other countries so that the
Components may be used in Dendreon Products and Kirin Products to be used in
human therapies.
ARTICLE 5
FINANCIAL OBLIGATIONS
5.1 Purchase Prices.
(a) Per Kirin's purchase of particular Dendreon Components hereunder,
Kirin shall pay Dendreon for the purchase of such Dendreon Components a transfer
price in an amount in U.S. Dollars equal to Dendreon's Fully-Burdened
Manufacturing Costs of such Dendreon Components plus a handling fee of [ * ];
provided, however, that for Dendreon Components that are purchased by Kirin for
use in a Dendreon Product for which the costs of manufacturing development
(including process development) was supported by Kirin pursuant to Section 5.3,
Kirin shall pay Dendreon a transfer price in an amount in U.S. Dollars equal to
Dendreon's Fully-Burdened Manufacturing Costs of such Dendreon Components for
such Dendreon Product plus a handling fee of [ * ]. Kirin shall pay Dendreon [ *
] of the transfer price for a particular order of Dendreon Components within
thirty (30) days of placing its order for such Dendreon Components, and [ * ] of
such transfer price within thirty (30) days of delivery of such Dendreon
Components, pursuant to Section 2.4.
(b) Per Dendreon's purchase of particular Kirin Components, Dendreon
shall pay Kirin for the purchase of such Kirin Components a transfer price in an
amount in U.S. Dollars equal to Kirin's Fully-Burdened Manufacturing Costs of
such Kirin Components plus a handling fee of [ * ]. Dendreon shall pay Kirin [ *
] of the transfer price for a particular order of Kirin Components within thirty
(30) days of placing its order for such Kirin Components, and [ * ] of such
transfer price within thirty (30) days of delivery of such Kirin Components,
pursuant to Section 2.4.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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5.2 Audit.
(a) Upon the written request of a Party (the "Auditing Party"), and
not more than once in each calendar year, the other Party (the "Audited Party")
shall permit an independent certified public accounting firm of nationally
recognized standing selected by the Auditing Party, and reasonably acceptable to
the Audited Party, at the Auditing Party's expense, to have access during normal
business hours, and upon reasonable prior written notice, to such of the records
of the Audited Party as may be reasonably necessary to verify the accuracy of
the reports of the Audited Party's Fully-Burdened Manufacturing Costs for
Components hereunder for any calendar year ending not more than thirty-six (36)
months prior to the date of such request. The accounting firm shall disclose to
the Auditing Party and the Audited Party only whether such reports are correct
or incorrect and the specific details concerning any discrepancies. No other
information shall be provided to the Auditing Party.
(b) If such accounting firm concludes that the Audited Party
overstated its Fully-Burdened Manufacturing Costs for a particular Component or
Components during such period, the Audited Party shall reimburse the Auditing
Party the difference between what the Auditing Party paid and what was actually
owed, with interest from the date originally due at the prime rate, as published
in The Wall Street Journal (Eastern U.S. Edition) on the last business day
preceding such date, within thirty (30) days after the date the Auditing Party
delivers to the Audited Party such accounting firm's written report. If the
amount of the difference is greater than five percent (5%) of the total amount
owed, then the Audited Party shall in addition reimburse the Auditing Party for
all costs related to such audit.
(c) The Auditing Party shall treat all information subject to review
under this Section 5.2 in accordance with the confidentiality provisions of
Article 6 of this Agreement, and shall cause its accounting firm to enter into
an acceptable confidentiality agreement with the Audited Party obligating such
firm to retain all such financial information in confidence pursuant to such
confidentiality agreement.
(d) If the Audited Party in good faith disputes the conclusion of the
accounting firm under subsection (b) above that the Audited Party overstated its
Fully-Burdened Manufacturing Costs for a particular Component or Components, or
any specific aspect of the conclusion, then the Audited Party shall inform the
Auditing Party by written notice within thirty (30) days of receiving a copy of
the audit containing such conclusion, specifying in detail the reasons for the
Audited Party's disputing such conclusion. The Parties shall promptly thereafter
meet and negotiate in good faith a resolution to such dispute. In the event that
the Parties are unable to resolve such dispute within sixty (60) days after such
Audited Party notice, the matter shall be resolved in a manner consistent with
the procedures set forth in Section 11.7.
5.3 Financing the Development of Dendreon Products. As set forth below,
Kirin shall have the option, but not the obligation, to provide financial
support for the development of Dendreon Products which Dendreon desires Kirin to
financially support and which are to be supplied to Kirin hereunder. To
exercise its option to support those certain Dendreon Products, Kirin shall
notify Dendreon in writing, within thirty (30) days of Kirin's receipt of
written notice from Dendreon that Dendreon is developing such a Dendreon
Product, that Kirin agrees to pay Dendreon for all of its scale-up and other
development costs related to the development of the Dendreon Components for such
Dendreon Product up to a total of [ * ] for such Dendreon
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Product. All payments due to Dendreon pursuant to this Section 5.3 shall be made
by Kirin within thirty (30) days of receipt of Dendreon's invoice therefor. The
foregoing option shall be exercised, if at all, on a product-by-product basis as
to each Dendreon Product for which Dendreon provides Kirin the applicable
notice.
ARTICLE 6
CONFIDENTIALITY
6.1 Confidentiality; Exceptions. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, the Parties agree
that, for the term of this Agreement and for ten (10) years thereafter, the
receiving Party shall keep confidential and shall not publish or otherwise
disclose to a Third Party or use for any purpose other than as provided for in
this Agreement any Information and materials furnished to it by the other Party
pursuant to this Agreement (collectively, "Confidential Information"), except to
the extent that it can be established by the receiving Party by competent proof
that such Confidential Information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of
the receiving Party in breach of this Agreement; or
(d) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others.
6.2 Authorized Disclosure. Each Party may disclose the other's
Confidential Information to the extent such disclosure is reasonably necessary
in filing or prosecuting patent applications, prosecuting or defending
litigation, complying with applicable governmental regulations or conducting
pre-clinical or clinical trials, provided that if a Party is required by law or
regulation to make any such disclosure of the other Party's Confidential
Information it will except where impracticable for necessary disclosures, for
example in the event of medical emergency, give reasonable advance notice to the
other Party of such disclosure requirement and, except to the extent
inappropriate in the case of patent applications, will use its best efforts to
secure confidential treatment of such Confidential Information required to be
disclosed.
6.3 Survival. This Article 6 shall survive the termination or expiration
of this Agreement for a period of ten (10) years.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 7
INTELLECTUAL PROPERTY
Unless specifically and expressly granted herein, no licenses or rights
under either Party's intellectual property rights are implied or granted in this
Agreement. Each Party shall retain full ownership of all its inventions and
intellectual property. The prosecution of any patents, patent applications and
any and all other intellectual property rights associated with the manufacture
and supply of Components shall be governed by the terms of the Collaborative
License Agreement.
ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1 General. Each of the Parties hereby represents and warrants: (a) the
Agreement is a legal and valid obligation binding upon such Party and
enforceable in accordance with its terms; (b) the execution, delivery and
performance of the Agreement by such Party does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a Party or by which
it is bound; and (c) the Agreement does not violate any law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.
8.2 Component Warranty.
(a) Dendreon warrants to Kirin, for a period of twelve (12) months
from delivery for Separation Devices and Reagent, a period of nine (9) months
from delivery for recombinant antigen PA 2024 and a period of six (6) months
from delivery for Dendreon Antigen other than recombinant antigen PA 2024, that
the Separation Devices, Reagent and Dendreon Antigen, as applicable, supplied by
Dendreon to Kirin shall: (i) be manufactured in accordance with current Good
Manufacturing Practices (for medical devices and drugs as promulgated and
amended by the FDA); and (ii) conform with applicable Dendreon specifications at
the time of delivery by Dendreon. The preceding warranty specifically excludes,
and Dendreon shall not be liable for, any action or omission by Kirin or any
other entity, specifically including any failure to store or transport Dendreon
Components (after Dendreon's delivery pursuant to Section 2.4(a)) in accordance
with applicable specifications, which results in the damage or destruction of
Dendreon Components after Dendreon has delivered the Dendreon Components to
Kirin pursuant to Section 2.4. Kirin's sole remedy for breach of the foregoing
warranty as to a particular Dendreon Component shall be repair, replacement or
refund of the purchase price paid by Kirin, at Dendreon's sole option.
(b) Kirin warrants to Dendreon, for a period of twelve (12) months
from delivery, pursuant to Section 2.4, for any Kirin Components other than
Kirin Antigen, and a period of six (6) months from delivery for Kirin Antigen,
that the Kirin Components supplied by Kirin to Dendreon shall: (i) be
manufactured in accordance with current Good Manufacturing Practices (for
medical devices and drugs as promulgated and amended by the FDA); and (ii)
conform with applicable Kirin specifications at the time of delivery by Kirin.
The preceding warranty specifically excludes, and Kirin shall not be liable for,
any action or omission by Dendreon or any other entity, specifically including
any failure to store or transport Kirin
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Components (after Kirin's delivery purusnat to Section 2.4(b)) in accordance
with applicable specifications, which results in the damage or destruction of
Kirin Components after Kirin has delivered the Kirin Components to Dendreon
pursuant to Section 2.4. Dendreon's sole remedy for breach of the foregoing
warranty as to a particular Kirin Component shall be repair, replacement or
refund of the purchase price paid by Dendreon, at Kirin's sole option.
8.3 Warranty Disclaimer. THE EXPRESS WARRANTIES IN THIS ARTICLE 8 ARE IN
LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT.
ARTICLE 9
TERM AND TERMINATION
9.1 Term. This Agreement shall commence on the Effective Date and, unless
sooner terminated as provided herein, shall continue in effect until the
expiration or termination of the Collaborative License Agreement, unless
extended upon the mutual, written agreement of the Parties.
9.2 Termination.
(a) If either Party materially breaches this Agreement at any time,
which breach is not cured within thirty (30) days of written notice thereof if
such breach is caused by the failure of a Party to meet its financial
obligations under this Agreement, or within ninety (90) days of written notice
thereof for any other material breach of this Agreement, from the non-breaching
Party specifying in detail the nature of the breach, the non-breaching Party
shall have the right to terminate the Agreement.
(b) Either Party may terminate this Agreement, effective immediately
upon the giving of written notice, if the other Party shall file a petition for
bankruptcy, or shall be adjudicated a bankrupt or insolvent, or shall take
advantage of the insolvency laws of any state of the United States or of any
country, or shall make an assignment for the benefit of creditors, or shall have
a receiver appointed, whether by private instrument or by court officer, for its
property which is not dismissed within sixty (60) days, or become subject to an
involuntary petition for bankruptcy which in not dismissed within sixty (60)
days.
9.3 Surviving Obligations. Termination or expiration of this Agreement
shall not (a) affect any other rights of either Party which may have accrued up
to the date of such termination or expiration, or (b) relieve Purchaser of its
obligation to pay to Supplier sums due in respect of Components delivered and
accepted prior to termination or expiration of this Agreement. The provisions of
Articles 6, 7 and 10, and Sections 4.4, 5.2 and 11.6 of this Agreement shall
survive termination or expiration of this Agreement.
9.4 Termination Without Cause. This Agreement may be terminated at any
time upon mutual, written agreement of the Parties.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 10
INDEMNIFICATION
10.1 Indemnification by Dendreon.
(a) Subject to compliance with Section 10.3, Dendreon agrees to
indemnify, defend and hold harmless Kirin, its Affiliates, and their respective
officers, directors, shareholders, representatives, agents and employees (the
"Kirin Indemnitees"), from and against any and all losses, liabilities, damages,
costs, fees and expenses, including reasonable legal costs and attorneys' fees
("Losses") resulting from a Third Party claim, suit or action based upon: (i)
death or injury to any person or damage to any property to the extent caused by
the defective or negligent manufacture of a Component or Product manufactured by
or on behalf of Dendreon and sold to Kirin and its Affiliates hereunder (the
"Defective Manufacturing Claim"); (ii) death or injury to any person or damage
to any property to the extent caused by the defective or negligent marketing or
promotion of a Product by Dendreon or its Affiliates hereunder (a "Defective
Marketing Claim"); (iii) harm or damage attributable to or caused by the acts or
omissions of Dendreon or its Affiliates or their respective officers, directors,
representatives, agents or employees; or (iv) breach of any representation or
warranty of Dendreon set forth in Article 8.
(b) Dendreon shall have no obligation under this Section 10.1 with
respect to any Losses resulting from: (i) the negligent or intentionally
wrongful act or omission of Kirin, its Affiliates or their respective officers,
directors, representatives, agents or employees; (ii) the improper storage,
transportation, marketing, training, or handling of a Component or Product by
any person or entity other than Dendreon, its Affiliates or their respective
officers, directors, representatives, agents or employees; (iii) the improper
use of a Component or Product by any person or entity other than Dendreon, its
Affiliates or their respective officers, directors, agents or employees; or (iv)
any claims based upon death or injury to any person or damage to any property
caused by a Component or Product that is attributable to or caused by acts or
omissions of Kirin or its sublicensees or their respective Affiliates or their
respective officers, directors, representatives, agents or employees. With
respect to any Third Party claim, suit or action based upon death or injury to
any person or damage to any property based on use of a Product, Dendreon agrees
to provide Kirin, at Kirin's expense, with reasonable assistance in Kirin's
defense of such claim, suit or action.
10.2 Indemnification by Kirin.
(a) Subject to compliance with Section 10.3, Kirin agrees to
indemnify and defend Dendreon, its Affiliates, and their respective officers,
directors, shareholders, representatives, agents and employees (the "Dendreon
Indemnitees"), from and against any and all Losses (as defined in Section 10.1)
resulting from a Third Party claim, suit or action based upon: (i) a Defective
Manufacturing Claim (as defined in Section 10.1); (ii) a Defective Marketing
Claim (as defined in Section 10.1); (iii) harm or damage attributable to or
caused by the acts or omissions of Kirin or its Affiliates or their respective
officers, directors, representatives, agents or employees; or (iv) breach of any
representation or warranty of Kirin in Article 8.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(b) Kirin shall have no obligation under this Section 10.2 with
respect to any Losses resulting from: (i) the negligent or intentionally
wrongful act or omission of Dendreon, its Affiliates or their respective
officers, directors, representatives, agents or employees; (ii) the improper
storage, transportation, marketing, training, or handling of a Component or
Product by entities or persons other than Kirin or its sublicensees or their
respective Affiliates, or their respective officers, directors, representatives,
agents or employees; (iii) the improper use of a Product or Component, unless
caused by Kirin or its sublicensees or their respective Affiliates, or their
respective officers, directors, representatives, agents or employees; or (iv)
any claims based upon death or injury to any person or damage to any property
caused by a Component or Product that is attributable to or caused by acts or
omissions of Dendreon or its sublicensees or their respective Affiliates or
their respective officers, directors, representatives, agents or employees. With
respect to any Third Party claim, suit or action based upon death or injury to
any person or damage to any property based on use of a Product, Kirin agrees to
provide Dendreon, at Dendreon's expense, with reasonable assistance in
Dendreon's defense of such claim, suit or action.
10.3 Indemnity Procedure. In the event that a Party is seeking
indemnification under Section 10.1 or 10.2, it shall inform the other Party (the
"Indemnifying Party") of a claim as soon as reasonably practicable after it
receives notice of the claim, shall permit the Indemnifying Party to assume
direction and control of the defense of the claim (including the right to settle
the claim solely for monetary consideration), and, at the Indemnifying Party's
expense, shall cooperate as reasonably requested in the defense of the claim.
The Indemnified Party shall have the right to retain its own counsel, subject to
the approval of any such outside counsel by the Indemnifying Party, with the
fees and expenses to be paid by the Indemnifying Party if representation of such
Party by the counsel retained by Indemnifying Party would be inappropriate due
to actual or potential differing interests between such indemnitee and any other
Party represented by such counsel in such proceedings. The Indemnifying Party
may not settle such action or claim, or otherwise consent to an adverse judgment
in such action or claim, without the express written consent of the Indemnified
Party if such settlement or adverse judgment diminishes the rights or interests
of the Indemnified Party.
ARTICLE 11
MISCELLANEOUS
11.1 Assignment. Neither Party shall assign any of its rights and
obligations hereunder except (i) as incident to the merger, consolidation,
reorganization or acquisition of stock affecting actual voting control or of
substantially all of the assets of the assigning Party; or (ii) to an Affiliate;
provided, however, that in no event shall either Party's rights and obligations
hereunder be assigned without prior written notice to the other Party. In any
case, neither Party may make an assignment of its assets which renders it unable
to perform its material obligations hereunder. This Agreement shall be binding
upon and inure to the benefit of the Parties hereto and their permitted
successors and assigns.
11.2 Retained Rights. Nothing in this Agreement shall limit in any
respect the right of either Party to conduct research and development with
respect to, and market products outside of, the Field using such Party's
Technology, but no license to use the other Party's technology to do so is
granted herein expressly or by implication.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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11.3 Force Majeure. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses on account of failure of
performance by the defaulting Party if the failure is occasioned by government
action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or
any other similar cause beyond the control of the defaulting Party, provided
that the Party claiming force majeure has exerted all reasonable efforts to
avoid or remedy such force majeure; provided, however, in no event shall a Party
be required to settle any labor dispute or disturbance.
11.4 Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
11.5 No Trademark Rights. Except as otherwise provided in the
Collaborative License Agreement, no right, express or implied, is granted by the
Agreement to use in any manner the name "Dendreon" or "Kirin" or any other trade
name or trademark of the other Party in connection with the performance of the
Agreement.
11.6 Notices. All notices and other communications hereunder shall be in
writing and shall be deemed given if delivered personally or by facsimile
transmission (receipt verified), telexed, mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by express courier service,
to the Parties at the following addresses (or at such other address for a Party
as shall be specified by like notice; provided, that notices of a change of
address shall be effective only upon receipt thereof):
If to Dendreon, addressed to:
Dendreon Corporation
▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇. ▇. ▇▇▇▇▇▇
Telephone:(▇▇▇) ▇▇▇-▇▇▇▇
Telecopy: (▇▇▇) ▇▇▇-▇▇▇▇
With copy to:
▇▇▇▇▇▇ Godward llp
Five ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, Esq.
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Telecopy: (▇▇▇) ▇▇▇-▇▇▇▇
If to Kirin, addressed to:
Kirin Brewery Co., Ltd.
▇▇-▇, ▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇
▇▇▇▇▇▇▇-▇▇
▇▇▇▇▇ ▇▇▇-▇▇▇▇, ▇▇▇▇▇
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Research and Product Development Department
Telephone: (▇▇) ▇▇▇▇-▇▇▇▇
Telecopy: (▇▇) ▇▇▇▇-▇▇▇▇
11.7 Dispute Resolution. If any dispute, controversy or claim arises out
of or in connection with this Agreement, the Parties shall use reasonable
efforts to settle it by friendly negotiation within sixty (60) days of notice
from one Party to the other of such dispute, controversy or claim, before
pursuing any other remedies available to them. If either Party fails or refuses
to participate in such negotiations, or if, in any event, the dispute,
controversy or claim is not resolved to the satisfaction of both Parties within
the sixty (60) day period, any such dispute, controversy or claim shall be
settled by arbitration. Any such arbitration shall be conducted in accordance
with the Japan-American Trade Arbitration Agreement of September 16, 1952. The
Parties agree that any such arbitration shall be conducted in the English
language in a location within the United States selected by the Party that did
not initiate such arbitration, and the Agreement shall be governed by and
construed in accordance with the laws of the State of California and the United
States of America. The arbitrators shall include one independent, un-affiliated
nominee selected by each Party and a third neutral arbitrator selected by such
nominees. The Parties agree that any arbitration panel shall include members
knowledgeable as to the evaluation of biopharmaceutical technology. Judgment
upon the award rendered may be entered in the highest state or federal court or
forum, state or federal, having jurisdiction; provided, however, that the
provisions of this Section 11.7 shall not apply to any dispute or controversy as
to which any treaty or law prohibits such arbitration. The prevailing Party
shall be entitled to reasonable attorney's fees and costs to be fixed by the
arbitrators.
11.8 Waiver. Except as specifically provided for herein, the waiver from
time to time by either of the Parties of any of their rights or their failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
same or of any other of such Party's rights or remedies provided in this
Agreement.
11.9 Severability. If any term, covenant or condition of this Agreement
or the application thereof to any Party or circumstance shall, to any extent, be
held to be invalid or unenforceable, then the remainder of this Agreement, or
the application of such term, covenant or condition to Parties or circumstances
other than those as to which it is held invalid or unenforceable, shall not be
affected thereby and each term, covenant or condition of this Agreement shall be
valid and be enforced to the fullest extent permitted by law.
11.10 Ambiguities. Ambiguities, if any, in this Agreement shall not be
construed against any Party, irrespective of which Party may be deemed to have
authored the ambiguous provision.
11.11 Entire Agreement. This Agreement sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties hereto with regard to the subject matter discussed herein
and supersedes and terminates all prior agreements and understanding between the
Parties with regard to the subject matter discussed herein. There are no
covenants, promises, agreements, warranties, representations conditions or
understandings, either oral or written, between the Parties with regard to the
subject matter discussed herein other than as set forth in this Agreement.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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11.12 Headings. The Section and Paragraph headings contained herein are
for the purposes of convenience only and are not intended to define or limit the
contents of the Section or Paragraphs to which they apply.
In Witness Whereof, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.
DENDREON CORPORATION KIRIN BREWERY CO., LTD.
By: /s/ ▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------- -------------------------------------
Managing Director
Title: President & CEO Title: President of Pharmaceutical
--------------- ----------------------------
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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EXHIBIT A
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.