Exhibit 10.15
AMENDED AND RESTATED
MANUFACTURING AND SUPPLY AGREEMENT
BETWEEN
DENDREON CORPORATION
AND
KIRIN BREWERY CO., LTD.
TABLE OF CONTENTS
Page
----
ARTICLE 1: DEFINITIONS................................................. 3
1.1 "Affiliate"................................................ 3
1.2 "Back-Up License".......................................... 3
1.3 "Business Day"............................................. 3
1.4 "Collaborative License Agreement".......................... 4
1.5 "Component" or "Components"................................ 4
1.6 "Controlled" or "Control".................................. 4
1.7 "Dendreon Antigen"......................................... 4
1.8 "Dendreon Component" or "Dendreon Components".............. 4
1.9 "Dendreon Product"......................................... 4
1.10 "Dendreon Technology"...................................... 5
1.11 "Dendritic Cell"........................................... 5
1.12 "Effective Date"........................................... 5
1.13 "Fully-Burdened Manufacturing Costs"....................... 5
1.14 "Information".............................................. 5
1.15 "Kirin Antigen"............................................ 5
1.16 "Kirin Component" or "Kirin Components".................... 6
1.17 "Kirin PA2024 Option"...................................... 6
1.18 "Kirin Product"............................................ 6
1.19 "Kirin Hiring Period"...................................... 6
1.20 "Licensed Dendreon Product"................................ 6
1.21 "Licensed Kirin Product"................................... 6
1.22 "Manufacturing and Supply Agreement"....................... 6
1.23 "Manufacturing Know-How"................................... 6
1.24 "Manufacturing Plan"....................................... 7
1.25 "Memorandum"............................................... 7
1.26 "Net Revenue".............................................. 7
1.27 "Non-listed Facilities".................................... 7
1.28 "Original Supply Agreement"................................ 7
i.
1.29 "PA2024 Price Election".................................... 8
1.30 "Parties' Agreements"...................................... 8
1.31 "Patent" .................................................. 8
1.32 "Product".................................................. 8
1.33 "Purchaser"................................................ 8
1.34 "Reagent".................................................. 8
1.35 "Reasonable Efforts"....................................... 8
1.36 "Research and License Agreement"........................... 8
1.37 "Regulatory Approval"...................................... 8
1.38 The "Restated Effective Date".............................. 9
1.39 "Scale" ................................................... 9
1.40 "Separation Devices"....................................... 9
1.41 "Steering Committee"....................................... 9
1.42 "Sublicensee".............................................. 9
1.43 "Supplier"................................................. 9
1.44 "Supplier Patent".......................................... 9
1.45 "Third Party".............................................. 9
ARTICLE 2: SUPPLY FOR CLINICAL DEVELOPMENT............................. 10
2.1 Supply for Clinical Development............................ 10
2.2 Forecasts.................................................. 10
2.3 Order Placement Procedure................................. 11
2.4 Delivery and Risk of Loss.................................. 12
2.5 Acceptance and Rejection................................... 12
2.6 Manufacturing Modifications................................ 14
2.7 Restrictions on Sale....................................... 14
2.8 Use of Separation Devices by Kirin Collaborators........... 14
ARTICLE 3: COMMERCIAL SUPPLY........................................... 15
3.1 Commercial Supply.......................................... 15
3.2 Preparation................................................ 15
3.3 Forecasts.................................................. 16
3.4 Order Placement Procedure.................................. 16
ii.
3.5 Inventory.................................................. 17
3.6 Amendments................................................. 17
3.7 Resolution of Supply Problems.............................. 18
3.8 Acceptance and Rejection................................... 20
3.9 Kirin Manufacture of Dendreon Components................... 21
ARTICLE 4: REGULATORY REQUIREMENTS..................................... 25
4.1 Manufacturing Facilities, Equipment and Licenses........... 25
4.2 Manufacturing Regulatory Matters........................... 25
4.3 Product Recall Procedures.................................. 26
4.4 Documentation.............................................. 27
ARTICLE 5: FINANCIAL OBLIGATIONS....................................... 27
5.1 Purchase Prices............................................ 27
5.2 Audit ..................................................... 30
5.3 Financing the Development of Dendreon Products............. 31
ARTICLE 6: CONFIDENTIALITY............................................. 32
6.1 Confidentiality; Exceptions................................ 32
6.2 Authorized Disclosure...................................... 32
6.3 Survival .................................................. 33
ARTICLE 7: INTELLECTUAL PROPERTY....................................... 33
ARTICLE 8: REPRESENTATIONS AND WARRANTIES.............................. 33
8.1 General ................................................... 33
8.2 Component Warranty......................................... 33
8.3 Warranty Disclaimer........................................ 34
ARTICLE 9: TERM AND TERMINATION........................................ 35
9.1 Term ...................................................... 35
9.2 Termination................................................ 35
9.3 Surviving Obligations...................................... 35
9.4 Termination Without Cause.................................. 36
ARTICLE 10: INDEMNIFICATION............................................. 36
10.1 Indemnification by Dendreon................................ 36
10.2 Indemnification by Kirin................................... 37
iii.
10.3 Indemnity Procedure........................................ 38
ARTICLE 11: MISCELLANEOUS............................................... 38
11.1 Assignment................................................. 38
11.2 Retained Rights............................................ 38
11.3 Force Majeure.............................................. 39
11.4 Further Actions............................................ 39
11.5 No Trademark Rights........................................ 39
11.6 Notices.................................................... 39
11.7 Dispute Resolution......................................... 40
11.8 Waiver..................................................... 41
11.9 Severability............................................... 41
11.10 Ambiguities................................................ 41
11.11 Entire Agreement........................................... 41
11.12 Headings................................................... 42
11.13 Undefined Terms............................................ 42
iv.
AMENDED AND RESTATED MANUFACTURING AND SUPPLY
AGREEMENT
This Amended and Restated Manufacturing and Supply Agreement (the
"Agreement" or "Manufacturing and Supply Agreement") is made and entered into
effective as of August 6, 2002 (the "Restated Effective Date") by and between
Dendreon Corporation, a Delaware corporation having its principal place of
business at 3005 1st Avenue, Seattle, Washington, U.S.A. ("Dendreon"), and Kirin
Brewery Co., Ltd., a corporation organized and existing under the laws of Japan
having its principal place of business at 10-1, Shinkawa 2-chome, Chuo-ku,
Tokyo, Japan ("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.
1.
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 making 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.
G. Kirin and Dendreon entered into a Manufacturing and Supply
Agreement on July 27, 1999 to formalize their plans set forth in Recitals A
through F. (The Manufacturing and Supply Agreement executed on July 27, 1999 is
hereinafter defined as the "Original Supply Agreement"; and the date of its
execution is hereinafter defined as the "Effective Date".)
H. Kirin and Dendreon entered into a Memorandum of Modifications to
Kirin and Dendreon Collaboration on August 3, 2001 (hereinafter defined as the
"Memorandum"). The Memorandum, among other things, directs that the Original
Supply Agreement be amended to conform to the Parties' agreements in the
Memorandum.
2.
I. Kirin has an option for a fully paid non-exclusive license (with
right to sublicense) to manufacture Dendreon Antigen PA2024 using Dendreon
Technology as set forth in this Agreement and in the Collaborative License
Agreement.
J. This Agreement and the Amended and Restated Collaborative
License Agreement of even date supercede and terminate the Memorandum.
Now, Therefore, the Parties agree to amend and restate the Original
Supply Agreement in its entirety 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.
3.
1.4 "COLLABORATIVE LICENSE AGREEMENT" shall mean the Amended and
Restated Collaborative License Agreement by and between the Parties of even
date.
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" OR "CONTROL" 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" shall 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, 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 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 administration 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.
4.
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 "EFFECTIVE DATE" means the date of the Original Supply
Agreement, July 27, 1999. Any amendment to the Original License Agreement
contained in this Agreement shall be effective as of the Restated Effective
Date.
1.13 "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.
1.14 "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.
1.15 "KIRIN ANTIGEN" means an antigen that is claimed by a patent or
is otherwise covered by intellectual property rights that are Controlled by
Kirin.
5.
1.16 "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.
1.17 "KIRIN PA2024 OPTION" shall have the meaning set forth in
Section 2.5 of the Collaborative License Agreement.
1.18 "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; 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 administration 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 writing to amend
and extend the definition of Kirin Product as provided in Section 5.8 of the
Collaborative License Agreement.
1.19 "KIRIN HIRING PERIOD" shall have the meaning set forth in
Section 3.9(b)(iii)(3).
1.20 "LICENSED DENDREON PRODUCT" shall have the meaning set forth in
Section 2.3(b) of the Collaborative License Agreement.
1.21 "LICENSED KIRIN PRODUCT" shall have the meaning set forth in
Section 2.4(b) of the Collaborative License Agreement.
1.22 "MANUFACTURING AND SUPPLY AGREEMENT" means this Agreement
1.23 "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.
6.
1.24 "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.
1.25 "MEMORANDUM" shall have the meaning set forth in Recital H.
1.26 "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 NHI Price 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
administration 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.
1.27 "NON-LISTED FACILITIES" shall have the meaning set forth in
Section 3.9(b)(iii)(3).
1.28 "ORIGINAL SUPPLY AGREEMENT" means the Manufacturing and Supply
Agreement by and between the Parties dated July 27, 1999.
7.
1.29 "PA2024 PRICE ELECTION" shall have the meaning set forth in
Section 5.1(a)(ii).
1.30 "PARTIES' AGREEMENTS" mean this Manufacturing and Supply
Agreement, the Parties' Amended and Restated Collaborative License Agreement, of
even date, the Parties' Research and License Agreement, dated February 1, 1999,
and the Parties' Joint Commercialization Agreement, dated February 1, 2001 and
all amendments thereto, but not the Memorandum.
1.31 "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.
1.32 "PRODUCT" means a Kirin Product or a Dendreon Product.
1.33 "PURCHASER" shall mean the Party purchasing Components from the
other Party to the Agreement, as applicable, in the applicable section.
1.34 "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.
1.35 "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.
1.36 "RESEARCH AND LICENSE AGREEMENT" shall mean the Research and
License Agreement by and between the Parties dated as of February 1, 1999.
1.37 "REGULATORY APPROVAL" means any approvals, licenses,
registrations or authorizations of any federal, state or local regulatory
agency, department, bureau or other
8.
government entity, necessary for the manufacture, use, storage, import,
transport or sale of Products in a regulatory jurisdiction.
1.38 THE "RESTATED EFFECTIVE DATE" means the date of this Agreement,
set forth in the preamble above.
1.39 "SCALE" means that the designated drug, antigen (e.g., PA2024),
reagent or biologic is manufactured at a specified per batch volume (e.g.,
2000L) all in accordance with cGMP such that each batch reliably and
reproducibly conforms to the specifications for the designated drug, antigen,
reagent or biologic.
1.40 "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 administration into a patient.
1.41 "STEERING COMMITTEE" shall have the meaning set forth in Section
3.1 of the Collaborative License Agreement.
1.42 "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.
1.43 "SUPPLIER" shall mean the Party supplying Components to the
other Party to the Agreement, its Affiliates or Sublicensees, as applicable, in
the applicable section.
1.44 "SUPPLIER PATENT" shall mean any Patent Controlled by the
Supplier during the term of the Agreement.
1.45 "THIRD PARTY" means any entity other than Dendreon or Kirin or
an Affiliate of Dendreon or Kirin.
9.
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. However, Dendreon's duty to sell to Kirin quantities of Dendreon
Antigen PA2024 shall terminate three (3) years after the date Kirin exercises
the Kirin PA2024 Option and receives Dendreon PA2024 Manufacturing Technology
for the manufacture of PA2024 under Section 2.5 of the Collaborative License
Agreement. In the absence of Kirin's exercise of the Kirin PA2024 Option,
Dendreon's obligation to furnish Kirin with Dendreon Antigen PA2024 shall
continue to be as set forth in this Agreement.
(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
10.
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 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
11.
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
12.
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, 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.
13.
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 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
14.
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.
ARTICLES 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.
In the event Dendreon implements improvements, upgrades or changes to Separation
Devices, Reagents and Dendreon Antigens, Kirin, its Affiliates and Sublicensees
shall have the right to continue to purchase the unimproved, un-upgraded or
unchanged Separation Devices, Reagents and Dendreon Antigens (i.e., the model
that Dendreon has been providing as provided in Section 5.1) necessary for use
in manufacturing or using Kirin Products or Licensed Dendreon Products for which
Regulatory Approval has been obtained in the Kirin Territory. However,
Dendreon's duty to sell to Kirin quantities of Dendreon Antigen PA2024 shall
terminate three (3) years after the date Kirin exercises the Kirin PA2024 Option
and receives Dendreon PA2024 Manufacturing Technology for the manufacture of
PA2024 under Section 2.5 of the Collaborative License Agreement. In the absence
of Kirin's exercise of the Kirin PA2024 Option, Dendreon's obligation to furnish
Kirin with Dendreon Antigen PA2024 shall continue to be as set forth in this
Agreement.
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
15.
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 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 twentyfive 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)
16.
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
manufacturing and supply circumstances regarding Components hereunder, the
Parties will
17.
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
18.
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 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
19.
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 two percent
(2%) 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 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
20.
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.
(a) 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 twenty percent (20%), with any
manufacture and supply to be governed by the
21.
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.
(b) Subject to the terms of its license to manufacture PA2024 (under
the Kirin PA2024 Option set forth in Section 2.5 of the Collaborative License
Agreement), Kirin shall manufacture PA2024 on the following terms and
conditions:
(i) Neither Kirin's manufacture nor use of PA2024 shall
interfere with Kirin's use of Reasonable Efforts to develop, obtain Regulatory
Approval in the Kirin Territory for, and market and sell in the Kirin Territory,
APC 8015.
(ii) The manufacturing shall be conducted in accordance with
all applicable laws, regulations and Regulatory Approvals.
(iii) Kirin may manufacture Dendreon Antigen PA2024 at
manufacturing facilities anywhere in the world on the following terms and
conditions:
(1) Kirin shall have no right to execute an agreement to
engage or hire any Third-Party manufacturing facility until after it exercises
the Kirin PA2024 Option. Kirin shall promptly notify Dendreon (within thirty
(30) days) after it engages or hires any Third-Party manufacturing facility.
Kirin may submit a request for a Third Party manufacturing facility under this
Section 3.9(b)(iii) without exercising the Kirin PA2024 Option. Kirin's request
for Third-Party manufacturing facilities under this Section 3.9(b)(iii) shall
not be treated as an exercise of the Kirin PA2024 Option (which exercise shall
require a separate notice).
(2) Prior to commencing manufacturing of PA2024 (from time
to time) at any Third-Party manufacturing facility outside the Kirin Territory,
Kirin shall notify and request Dendreon's approval of Kirin's good faith plan to
commence manufacturing operations at a specific manufacturing facility (which
notice from Kirin shall specify the address of the Third-Party manufacturing
facility, the status of the tentative facility's Regulatory Approval, the
tentative facility's estimated, available manufacturing capacity, the owner of
the tentative facility and the owner's Affiliates to the extent information on
the owner's Affiliates is reasonably
22.
available). Dendreon shall have the right to disapprove Kirin's plan to use the
Third-Party manufacturing facility only if Dendreon has actual manufacturing
plans for the facility at the time of Kirin's request. Dendreon shall give
notice of its approval or disapproval within fifteen (15) days after Kirin gives
its notice of intended use. If Dendreon approves Kirin's plan or fails to give
timely disapproval, then Kirin shall have the right to commence manufacturing
operations of PA2024 at the facility within the next five hundred forty (540)
days. If the five hundred forty (540) days expire without Kirin commencing
manufacturing operations at the facility, then Dendreon's approval shall be
deemed to lapse and Kirin shall be required to again request Dendreon's approval
(under the first sentence of this Section 3.9(b)(iii)(2)) before commencing
manufacturing operations. If Dendreon gives notice of disapproval of the
manufacturing facility, then Kirin shall have no right to commence manufacturing
at (or otherwise engage or hire) the facility for the manufacture of PA2024.
Kirin shall have no right to engage or hire more than one (1) Third-Party
manufacturing facility at a time under this Section 3.9(b)(iii)(2) without
requesting Dendreon's approval for each such facility (under the first sentence
of this Section 3.9(b)(iii)(2)). As used in this Agreement, "actual
manufacturing plans" mean that a written proposal, letter of intent or purchase
order has been delivered to the Third-Party manufacturing facility about
engaging or hiring the facility, but not necessarily the achievement of a
manufacturing agreement or option with the Third-Party manufacturing facility.
(3) If Dendreon gives notice of disapproval of Kirin's
intended use of a specific Third-Party manufacturing facility under Section
3.9(b)(iii)(2), then the notice of disapproval shall be accompanied by
Dendreon's list of Third-Party manufacturing facilities for which Dendreon has
actual manufacturing plans; and the list shall be deemed to include the
Third-Party manufacturing facilities for which Dendreon had disapproved Kirin's
manufacturing plans under Section 3.9(b)(iii)(2). Kirin shall have no right to
commence manufacturing of PA2024 at (or otherwise engage or hire) the listed
facilities. If Dendreon lists no Third-Party manufacturing facilities or fails
to deliver its list with the notice of disapproval, then all Third-Party
manufacturing facilities (except the Third-Party manufacturing facilities for
which Dendreon had disapproved Kirin's manufacturing plans under Section
3.9(b)(iii)(2)) shall be deemed to be non-listed (the "Non-listed Facilities").
After Dendreon delivers its list or fails to
23.
deliver its list in a timely manner, Kirin shall then have the right to commence
manufacturing of PA2024 at up to two (2) Non-listed Facilities within a period
starting on the date of Dendreon's notice of its list or, if no list is
delivered, the due date for Dendreon's list and ending on the earlier of (a)
five hundred forty (540) days after the start date or (b) upon Kirin's
engagement or hire of two (2) Non-listed Facilities (the "Kirin Hiring Period").
After the Kirin Hiring Period expires, if Kirin then wishes to engage or hire
any additional Third-Party manufacturing facilities, Kirin shall be required to
request Dendreon's approval of a specific Third-Party manufacturing facility
(under the first sentence of Section 3.9(b)(iii)(2)).
(4) Prior to commencing manufacturing of PA2024 (from time
to time) at any Non-listed facility during the Kirin Hiring Period, Dendreon
shall notify and request Kirin's approval of Dendreon's good faith plan to
commence manufacturing operations at a specific manufacturing facility (which
notice from Dendreon shall specify the address of the Third-Party manufacturing
facility, the status of the tentative facility's Regulatory Approval, the
tentative facility's estimated, available manufacturing capacity, the owner of
the tentative facility and the owner's Affiliates to the extent information on
the owner's Affiliates is reasonably available). During the Kirin Hiring Period,
Dendreon shall have the right to commence manufacturing of PA2024 at up to two
(2) Non-listed Facilities. Dendreon shall not engage or hire any Non-listed
Facility during the Kirin Hiring Period without Kirin's approval, which approval
may be withheld for up to two (2) Non-listed Facilities and which approval may
be withheld based solely upon Kirin's actual manufacturing plans for the
facility at the time of Dendreon's request. Kirin shall give notice of its
approval or disapproval within fifteen (15) days after Dendreon gives its notice
of intended use. If Kirin approves Dendreon's plan or fails to give timely
disapproval, then Dendreon shall have the right to commence manufacturing
operations of PA2024 at the facility at any time thereafter. If Dendreon
commences manufacturing operations at the facility, the facility shall then be
treated as appearing on Dendreon's list (as defined in Section 3.9(b)(iii)(3)).
If Kirin disapproves Dendreon's request to engage or hire a Non-listed Facility,
then Dendreon shall have no right to commence manufacturing (or otherwise engage
or hire) the Non-listed Facility for the manufacture of PA2024 during the Kirin
Hiring Period.
24.
(5) Dendreon may not restrict Kirin's right to select
Third-Party manufacturing facilities within the Kirin Territory and may not
restrict Kirin's right to manufacture PA2024 at any manufacturing facility
anywhere in the world that is wholly owned by Kirin or by one of its Affiliates.
Outside the Kirin Hiring Period, Dendreon shall have the right to hire or engage
any Third-Party manufacturing facility for PA2024 without Kirin's approval. Upon
the request of any Party after the Kirin PA2024 Option is exercised, the Parties
shall confer and exchange information about their manufacturing plans for
PA2024.
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.
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
25.
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
26.
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 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) KIRIN'S PURCHASE OF PARTICULAR DENDREON COMPONENTS.
(i) Per Kirin's purchase of particular Dendreon
Components hereunder (except for the purchase of Dendreon Antigen PA2024, the
purchase of which is addressed in Section 5.1(a)(ii)), 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
27.
Manufacturing Costs of such Dendreon Components plus a handling fee of twenty
percent (20%); 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 ten percent
(10%). For its purchase of Dendreon Separation Devices, Kirin shall pay Dendreon
a transfer price in an amount in U.S. dollars equal to Dendreon's Fully-Burdened
Manufacturing Costs of the Separation Devices, plus a handling fee of ten
percent (10%). (The Parties acknowledge and agree that Kirin supported the costs
of manufacturing development of the Separation Devices so that Kirin is entitled
to the purchase price set forth in the preceding sentence.) Kirin shall pay
Dendreon fifty percent (50%) of the transfer price for a particular order of
Dendreon Components within thirty (30) days of placing its order for such
Dendreon Components, and fifty percent (50%) of such transfer price within
thirty (30) days of delivery of such Dendreon Components, pursuant to Section
2.4.
(ii) Per Kirin's purchase of Dendreon Antigen PA2024
(which is a Dendreon Component), Kirin shall pay Dendreon the purchase price
calculated as follows: for PA2024 manufactured up to and at the 2000L Scale,
Kirin shall pay Dendreon a transfer price in U.S. dollars in the amount of
Dendreon's Fully-Burdened Manufacturing Costs of PA2024 at the time of its
manufacture, plus a handling fee of ten percent (10%). Kirin's transfer price
for PA2024 shall equal (in U.S. dollars) the Fully-Burdened Manufacturing Costs
of PA2024 last manufactured at the 2000L Scale plus a handling fee of ten
percent (10%), even if Dendreon scales up the manufacture of PA2024 to greater
than 2000L Scale from time to time. In calculating the transfer price of PA2024
above, all costs shall be excluded for scaling up the manufacture of PA2024 to
the 2000L Scale. However, in the event from time to time Dendreon scales up the
manufacture of PA2024 to greater than 2000L Scale, Kirin may elect in writing
(the "PA2024 Price Election") to purchase PA2024 at a transfer price in U.S.
Dollars equal to Dendreon's Fully-Burdened Manufacturing Costs of PA2024 at the
time of manufacture at such greater Scale, plus a handling fee of ten percent
(10%). Kirin's PA2024 Price Election shall apply to all of Kirin's purchase
orders for PA2024 placed from the date the election is made until
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Kirin gives notice to Dendreon of a new PA2024 Price Election, whereupon, Kirin
shall become obligated to pay a transfer price in U.S. Dollars equal to
Dendreon's Fully-Burdened Manufacturing Costs of PA2024 at the time of
manufacture at such greater Scale, plus a handling fee of ten percent (10%).
Prior to each PA2024 Price Election, Kirin may notify Dendreon in writing of
Kirin's good faith tentative intention to make the election, and request a
statement from Dendreon of the actual scale-up costs to Dendreon of the scale-up
to that manufacturing level. Dendreon shall furnish Kirin with a statement of
such scale-up costs no later than thirty (30) days after Kirin requests such
statement. Dendreon shall furnish Kirin, at Kirin's request, periodic progress
reports on such scale-up costs and efforts. At the time Kirin makes a PA2024
Price Election, Kirin shall become obligated to reimburse to Dendreon as part of
the transfer price: (a) ten percent (10%) of the documented cost (in U.S.
dollars) to Dendreon of the scale-up to which the PA2024 Price Election and
purchase relates and (b) ten percent (10%) of the documented cost (in U.S.
dollars) to Dendreon of any lesser scale-up costs not previously reimbursed by
Kirin to Dendreon. The full reimbursable amount under the preceding sentence
shall be paid as part of the transfer price of the first order placed by Kirin
under the PA2024 Price Election. Kirin shall pay Dendreon fifty percent (50%) of
the transfer price for a particular order of PA2024 within thirty (30) days of
placing its order for PA2024, and fifty percent (50%) of such transfer price
within thirty (30) days of delivery of the ordered PA2024, pursuant to Section
2.4.
(b) DENDREON'S PURCHASE OF PARTICULAR KIRIN COMPONENTS. 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 twenty percent (20%). Dendreon shall pay Kirin
fifty percent (50%) of the transfer price for a particular order of Kirin
Components within thirty (30) days of placing its order for such Kirin
Components, and fifty percent (50%) of such transfer price within thirty (30)
days of delivery of such Kirin Components, pursuant to Section 2.4.
29.
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 (1) the reports of the Audited Party's Fully-Burdened Manufacturing
Costs for Components hereunder or (2) Dendreon's claim for reimbursement of
scale-up costs under Section 5.1(a)(ii). However, the Audited Party shall only
be obligated to maintain and produce records 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.
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(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.
(a) 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 one million U.S.
dollars ($1,000,000) for such Dendreon 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.
(b) The Parties acknowledge that Kirin has properly
exercised its option to provide financial support for Licensed Dendreon Products
APC 8015 and APC 8020 within the meaning of Section 5.3(a) of the Agreement and
that Kirin has provided its full share of such financial support for purposes of
fixing the transfer price of the Separation Devices and PA2024.
31.
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
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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.
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
33.
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 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 Components 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.
34.
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 3.9(b), 4.4, 5.2 and 11.6 of
this Agreement shall survive termination or expiration of this Agreement.
35.
9.4 TERMINATION WITHOUT CAUSE. This Agreement may be terminated at
any time upon mutual, written agreement of the Parties.
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,
36.
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.
(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.
37.
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.
38.
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
3005 1/st/ Avenue
Seattle, WA 98121-1010
Attention: General Counsel
Telephone: (206)256-4545
Facsimile: (206)256-0571
With copy to:
39.
McNaul Ebel Nawrot Helgren & Vance P.L.L.C.
One Union Square
600 University Street, Suite 2700
Seattle, WA 98101-3143
Attention: Peter M. Vial, Esq.
Telephone: (206)467-1816
Facsimile: (206)624-5128
If to Kirin, addressed to:
Kirin Brewery Co., Ltd.
26-1, Jingumae 6-chome
Shibuya-ku
Tokyo 150-8011, Japan
Attention: General Manager
Planning Department
Pharmaceutical Division
Telephone: (03)5485-6292
Facsimile: (03)5485-6316
With a copy to:
Pennie & Edmonds LLP
1155 Avenue of the Americas
New York, NY 10036
Attention: Rory J. Radding, Esq.
Telephone: (212)790-9090
Facsimile: (212)869-9741
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,
40.
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, unaffiliated 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 and any agreements referenced
herein set 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. Specifically, this Agreement supercedes and
terminates the Original Supply Agreement and the Memorandum. There are no
covenants, promises, agreements, warranties, representations conditions or
understandings, either oral or
41.
written, between the Parties with regard to the subject matter discussed herein
other than as set forth in this Manufacturing and Supply Agreement or any
agreements referenced herein. For clarity, a redlined version of this Agreement,
showing the changes made to the Original Supply Agreement, is attached hereto as
Exhibit A. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties hereto unless reduced to writing and
signed by the respective authorized officers of the Parties.
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.
11.13 UNDEFINED TERMS. Terms that are capitalized but undefined in
this Manufacturing and Supply Agreement shall be defined as set forth in any
other of the Parties' Agreements (and in amendments to the foregoing
agreements). Terms that are capitalized but undefined in any amendment to this
Manufacturing and Supply Agreement shall be defined as set forth in this
Manufacturing and Supply Agreement and in any other of the Parties' Agreements
(and in amendments to the foregoing agreements). However, if there is a conflict
or inconsistency between the definition of a capitalized term appearing in this
Manufacturing and Supply Agreement or in any amendments hereto, on the one hand,
and a definition of the same capitalized term appearing in any other of the
Parties' Agreements and amendments thereto, on the other, then the definition of
the capitalized term set forth in the Collaborative License Agreement and in the
amendment hereto shall control.
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/[ILLEGIBLE] By: /s/ [ILLEGIBLE]
------------------------- --------------------------------------
Title: 6 August '02 Title: President, Pharmaceutical Division
---------------------- -----------------------------------
42.
EXHIBIT A
REDLINED AGREEMENT
AMENDED AND RESTATED MANUFACTURING AND SUPPLY
AGREEMENT
This Amended and Restated Manufacturing and Supply Agreement (the
"Agreement" or "Manufacturing and Supply Agreement") is made and entered into
effective as of August 6, 2002 (the "Restated Effective Date") by and between
Dendreon Corporation, a Delaware corporation having its principal place of
business at 3005 1st Avenue, Seattle, Washington, U.S.A. ("Dendreon"), and Kirin
Brewery Co., Ltd., a corporation organized and existing under the laws of Japan
having its principal place of business at 10-1, Shinkawa 2-chome, Chuo-ku,
Tokyo, Japan ("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.
43.
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.
G. Kirin and Dendreon entered into a Manufacturing and Supply
Agreement on July 27, 1999 to formalize their plans set forth in Recitals A
through F. (The Manufacturing and Supply Agreement executed on July 27, 1999 is
hereinafter defined as the "Original Supply Agreement"; and the date of its
execution is hereinafter defined as the "Effective Date".)
H. Kirin and Dendreon entered into a Memorandum of Modifications to
Kirin and Dendreon Collaboration on August 3, 2001 (hereinafter defined as the
"Memorandum"). The Memorandum, among other things, directs that the Original
Supply Agreement be amended to conform to the Parties' agreements in the
Memorandum.
I. Kirin has an option for a fully paid non-exclusive license (with
right to sublicense) to manufacture Dendreon Antigen PA2024 using Dendreon
Technology as set forth in this Agreement and in the Collaborative License
Agreement.
J. This Agreement and the Amended and Restated Collaborative
License Agreement of even date supercede and terminate the Memorandum.
44.
Now, Therefore, the Parties agree to amend and restate the Original
Supply Agreement in its entirety 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" shall mean the Amended and
Restated Collaborative License Agreement by and between the Parties of even
date.
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.
45.
1.6 "CONTROLLED" OR "CONTROL" 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" shall 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, 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 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 administration 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.
46.
1.12 "EFFECTIVE DATE" means the date of the Original Supply
Agreement, July 27, 1999. Any amendment to the Original License Agreement
contained in this Agreement shall be effective as of the Restated Effective
Date.
1.13 "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.
1.14 "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.
1.15 "KIRIN ANTIGEN" means an antigen that is claimed by a patent or
is otherwise covered by intellectual property rights that are Controlled by
Kirin.
1.16 "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.
1.17 "KIRIN PA2024 OPTION" shall have the meaning set forth in
Section 2.5 of the Collaborative License Agreement.
47.
1.18 "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; 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 administration 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 writing to amend
and extend the definition of Kirin Product as provided in Section 5.8 of the
Collaborative License Agreement.
1.19 "KIRIN HIRING PERIOD" shall have the meaning set forth in
Section 3.9(b)(iii)(3).
1.20 "LICENSED DENDREON PRODUCT" shall have the meaning set forth in
Section 2.3(b) of the Collaborative License Agreement.
1.21 "LICENSED KIRIN PRODUCT" shall have the meaning set forth in
Section 2.4(b) of the Collaborative License Agreement.
1.22 "MANUFACTURING AND SUPPLY AGREEMENT" means this Agreement
1.23 "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.
1.24 "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.
1.25 "MEMORANDUM" shall have the meaning set forth in Recital H.
48.
1.26 "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 NHI Price 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
administration 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.
1.27 "NON-LISTED FACILITIES" shall have the meaning set forth in
Section 3.9(b)(iii)(3).
1.28 "ORIGINAL SUPPLY AGREEMENT" means the Manufacturing and Supply
Agreement by and between the Parties dated July 27, 1999.
1.29 "PA2024 PRICE ELECTION" shall have the meaning set forth in
Section 5.1(a)(ii).
1.30 "PARTIES' AGREEMENTS" mean this Manufacturing and Supply
Agreement, the Parties' Amended and Restated Collaborative License Agreement, of
even date, the Parties' Research and License Agreement, dated February 1, 1999,
and the Parties' Joint Commercialization Agreement, dated February 1, 2001 and
all amendments thereto, but not the Memorandum.
49.
1.31 "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.
1.32 "PRODUCT" means a Kirin Product or a Dendreon Product.
1.33 "PURCHASER" shall mean the Party purchasing Components from the
other Party to the Agreement, as applicable, in the applicable section.
1.34 "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.
1.35 "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.
1.36 "RESEARCH AND LICENSE AGREEMENT" shall mean the Research and
License Agreement by and between the Parties dated as of February 1, 1999.
1.37 "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.
1.38 The "RESTATED EFFECTIVE DATE" means the date of this Agreement,
set forth in the preamble above.
50.
1.39 "SCALE" means that the designated drug, antigen (e.g., PA2024),
reagent or biologic is manufactured at a specified per batch volume (e.g.,
2000L) all in accordance with cGMP such that each batch reliably and
reproducibly conforms to the specifications for the designated drug, antigen,
reagent or biologic.
1.40 "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 administration into a patient.
1.41 "STEERING COMMITTEE" shall have the meaning set forth in Section
3.1 of the Collaborative License Agreement.
1.42 "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.
1.43 "SUPPLIER" shall mean the Party supplying Components to the
other Party to the Agreement, its Affiliates or Sublicensees, as applicable, in
the applicable section.
1.44 "SUPPLIER PATENT" shall mean any Patent Controlled by the
Supplier during the term of the Agreement.
1.45 "THIRD PARTY" means any entity other than Dendreon or Kirin or
an Affiliate of Dendreon or Kirin.
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
51.
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. However, Dendreon's duty to sell to Kirin quantities of Dendreon
Antigen PA2024 shall terminate three (3) years after the date Kirin exercises
the Kirin PA2024 Option and receives Dendreon PA2024 Manufacturing Technology
for the manufacture of PA2024 under Section 2.5 of the Collaborative License
Agreement. In the absence of Kirin's exercise of the Kirin PA2024 Option,
Dendreon's obligation to furnish Kirin with Dendreon Antigen PA2024 shall
continue to be as set forth in this Agreement.
(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
52.
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 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
53.
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, 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
54.
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.
55.
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 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.
56.
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.
In the event Dendreon implements improvements, upgrades or changes to Separation
Devices, Reagents and Dendreon Antigens, Kirin, its Affiliates and Sublicensees
shall have the right to continue to purchase the unimproved, un-upgraded or
unchanged Separation Devices, Reagents and Dendreon Antigens (i.e., the model
that Dendreon has been providing as provided in Section 5.1) necessary for use
in manufacturing or using Kirin Products or Licensed Dendreon Products for which
Regulatory Approval has been obtained in the Kirin Territory. However,
Dendreon's duty to sell to Kirin quantities of Dendreon Antigen PA2024 shall
terminate three (3) years after the date Kirin exercises the Kirin PA2024 Option
and receives Dendreon PA2024 Manufacturing Technology for the manufacture of
PA2024 under Section 2.5 of the Collaborative License Agreement. In the absence
of Kirin's exercise of the Kirin PA2024 Option, Dendreon's obligation to furnish
Kirin with Dendreon Antigen PA2024 shall continue to be as set forth in this
Agreement.
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
57.
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 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
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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
manufacturing and supply circumstances regarding Components hereunder, the
Parties will discuss in good faith appropriate amendments to the applicable
mechanisms in the Supply Procedures.
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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
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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 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
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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 two percent
(2%) 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 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,
62.
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.
(a) 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 twenty percent (20%), 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.
63.
(b) Subject to the terms of its license to manufacture
PA2024 (under the Kirin PA2024 Option set forth in Section 2.5 of the
Collaborative License Agreement), Kirin shall manufacture PA2024 on the
following terms and conditions:
(i) Neither Kirin's manufacture nor use of PA2024
shall interfere with Kirin's use of Reasonable Efforts to develop, obtain
Regulatory Approval in the Kirin Territory for, and market and sell in the Kirin
Territory, APC 8015.
(ii) The manufacturing shall be conducted in
accordance with all applicable laws, regulations and Regulatory Approvals.
(iii) Kirin may manufacture Dendreon Antigen PA2024 at
manufacturing facilities anywhere in the world on the following terms and
conditions:
(1) Kirin shall have no right to execute an
agreement to engage or hire any Third-Party manufacturing facility until after
it exercises the Kirin PA2024 Option. Kirin shall promptly notify Dendreon
(within thirty (30) days) after it engages or hires any Third-Party
manufacturing facility. Kirin may submit a request for a Third Party
manufacturing facility under this Section 3.9(b)(iii) without exercising the
Kirin PA2024 Option. Kirin's request for Third-Party manufacturing facilities
under this Section 3.9(b)(iii) shall not be treated as an exercise of the Kirin
PA2024 Option (which exercise shall require a separate notice).
(2) Prior to commencing manufacturing of PA2024
(from time to time) at any Third-Party manufacturing facility outside the Kirin
Territory, Kirin shall notify and request Dendreon's approval of Kirin's good
faith plan to commence manufacturing operations at a specific manufacturing
facility (which notice from Kirin shall specify the address of the Third-Party
manufacturing facility, the status of the tentative facility's Regulatory
Approval, the tentative facility's estimated, available manufacturing capacity,
the owner of the tentative facility and the owner's Affiliates to the extent
information on the owner's Affiliates is reasonably available). Dendreon shall
have the right to disapprove Kirin's plan to use the Third-Party manufacturing
facility only if Dendreon has actual manufacturing plans for the facility at the
time of Kirin's request. Dendreon shall give notice of its approval or
disapproval within fifteen (15) days after Kirin gives its notice of intended
use. If Dendreon approves Kirin's plan or fails
64.
to give timely disapproval, then Kirin shall have the right to commence
manufacturing operations of PA2024 at the facility within the next five hundred
forty (540) days. If the five hundred forty (540) days expire without Kirin
commencing manufacturing operations at the facility, then Dendreon's approval
shall be deemed to lapse and Kirin shall be required to again request Dendreon's
approval (under the first sentence of this Section 3.9(b)(iii)(2)) before
commencing manufacturing operations. If Dendreon gives notice of disapproval of
the manufacturing facility, then Kirin shall have no right to commence
manufacturing at (or otherwise engage or hire) the facility for the manufacture
of PA2024. Kirin shall have no right to engage or hire more than one (1)
Third-Party manufacturing facility at a time under this Section 3.9(b)(iii)(2)
without requesting Dendreon's approval for each such facility (under the first
sentence of this Section 3.9(b)(iii)(2)). As used in this Agreement, "actual
manufacturing plans" mean that a written proposal, letter of intent or purchase
order has been delivered to the Third-Party manufacturing facility about
engaging or hiring the facility, but not necessarily the achievement of a
manufacturing agreement or option with the Third-Party manufacturing facility.
(3) If Dendreon gives notice of disapproval of
Kirin's intended use of a specific Third-Party manufacturing facility under
Section 3.9(b)(iii)(2), then the notice of disapproval shall be accompanied by
Dendreon's list of Third-Party manufacturing facilities for which Dendreon has
actual manufacturing plans; and the list shall be deemed to include the
Third-Party manufacturing facilities for which Dendreon had disapproved Kirin's
manufacturing plans under Section 3.9(b)(iii)(2). Kirin shall have no right to
commence manufacturing of PA2024 at (or otherwise engage or hire) the listed
facilities. If Dendreon lists no Third-Party manufacturing facilities or fails
to deliver its list with the notice of disapproval, then all Third-Party
manufacturing facilities (except the Third-Party manufacturing facilities for
which Dendreon had disapproved Kirin's manufacturing plans under Section
3.9(b)(iii)(2)) shall be deemed to be non-listed (the "Non-listed Facilities").
After Dendreon delivers its list or fails to deliver its list in a timely
manner, Kirin shall then have the right to commence manufacturing of PA2024 at
up to two (2) Non-listed Facilities within a period starting on the date of
Dendreon's notice of its list or, if no list is delivered, the due date for
Dendreon's list and ending on the earlier of (a) five hundred forty (540) days
after the start date or (b) upon Kirin's engagement or
65.
hire of two (2) Non-listed Facilities (the "Kirin Hiring Period"). After the
Kirin Hiring Period expires, if Kirin then wishes to engage or hire any
additional Third-Party manufacturing facilities, Kirin shall be required to
request Dendreon's approval of a specific Third-Party manufacturing facility
(under the first sentence of Section 3.9(b)(iii)(2)).
(4) Prior to commencing manufacturing of PA2024
(from time to time) at any Non-listed facility during the Kirin Hiring Period,
Dendreon shall notify and request Kirin's approval of Dendreon's good faith plan
to commence manufacturing operations at a specific manufacturing facility (which
notice from Dendreon shall specify the address of the Third-Party manufacturing
facility, the status of the tentative facility's Regulatory Approval, the
tentative facility's estimated, available manufacturing capacity, the owner of
the tentative facility and the owner's Affiliates to the extent information on
the owner's Affiliates is reasonably available). During the Kirin Hiring Period,
Dendreon shall have the right to commence manufacturing of PA2024 at up to two
(2) Non-listed Facilities. Dendreon shall not engage or hire any Non-listed
Facility during the Kirin Hiring Period without Kirin's approval, which approval
may be withheld for up to two (2) Non-listed Facilities and which approval may
be withheld based solely upon Kirin's actual manufacturing plans for the
facility at the time of Dendreon's request. Kirin shall give notice of its
approval or disapproval within fifteen (15) days after Dendreon gives its notice
of intended use. If Kirin approves Dendreon's plan or fails to give timely
disapproval, then Dendreon shall have the right to commence manufacturing
operations of PA2024 at the facility at any time thereafter. If Dendreon
commences manufacturing operations at the facility, the facility shall then be
treated as appearing on Dendreon's list (as defined in Section 3.9(b)(iii)(3)).
If Kirin disapproves Dendreon's request to engage or hire a Non-listed Facility,
then Dendreon shall have no right to commence manufacturing (or otherwise engage
or hire) the Non-listed Facility for the manufacture of PA2024 during the Kirin
Hiring Period.
(5) Dendreon may not restrict Kirin's right to
select Third-Party manufacturing facilities within the Kirin Territory and may
not restrict Kirin's right to manufacture PA2024 at any manufacturing facility
anywhere in the world that is wholly owned by Kirin or by one of its Affiliates.
Outside the Kirin Hiring Period, Dendreon shall have the right to hire or engage
any Third-Party manufacturing facility for PA2024 without Kirin's
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approval. Upon the request of any Party after the Kirin PA2024 Option is
exercised, the Parties shall confer and exchange information about their
manufacturing plans for PA2024.
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.
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
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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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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) KIRIN'S PURCHASE OF PARTICULAR DENDREON COMPONENTS.
(i) Per Kirin's purchase of particular Dendreon
Components hereunder (except for the purchase of Dendreon Antigen PA2024, the
purchase of which is addressed in Section 5.1(a)(ii)), 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 twenty percent (20%); provided,
however, that for Dendreon Components that are purchased by Kirin for use in a
Dendreon
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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 ten percent (10%). For its purchase of Dendreon
Separation Devices, Kirin shall pay Dendreon a transfer price in an amount in
U.S. dollars equal to Dendreon's Fully-Burdened Manufacturing Costs of the
Separation Devices, plus a handling fee of ten percent (10%). (The Parties
acknowledge and agree that Kirin supported the costs of manufacturing
development of the Separation Devices so that Kirin is entitled to the purchase
price set forth in the preceding sentence.) Kirin shall pay Dendreon fifty
percent (50%) of the transfer price for a particular order of Dendreon
Components within thirty (30) days of placing its order for such Dendreon
Components, and fifty percent (50%) of such transfer price within thirty (30)
days of delivery of such Dendreon Components, pursuant to Section 2.4.
(ii) Per Kirin's purchase of Dendreon Antigen PA2024
(which is a Dendreon Component), Kirin shall pay Dendreon the purchase price
calculated as follows: for PA2024 manufactured up to and at the 2000L Scale,
Kirin shall pay Dendreon a transfer price in U.S. dollars in the amount of
Dendreon's Fully-Burdened Manufacturing Costs of PA2024 at the time of its
manufacture, plus a handling fee of ten percent (10%). Kirin's transfer price
for PA2024 shall equal (in U.S. dollars) the Fully-Burdened Manufacturing Costs
of PA2024 last manufactured at the 2000L Scale plus a handling fee of ten
percent (10%), even if Dendreon scales up the manufacture of PA2024 to greater
than 2000L Scale from time to time. In calculating the transfer price of PA2024
above, all costs shall be excluded for scaling up the manufacture of PA2024 to
the 2000L Scale. However, in the event from time to time Dendreon scales up the
manufacture of PA2024 to greater than 2000L Scale, Kirin may elect in writing
(the "PA2024 Price Election") to purchase PA2024 at a transfer price in U.S.
Dollars equal to Dendreon's Fully-Burdened Manufacturing Costs of PA2024 at the
time of manufacture at such greater Scale, plus a handling fee of ten percent
(10%). Kirin's PA2024 Price Election shall apply to all of Kirin's purchase
orders for PA2024 placed from the date the election is made until Kirin gives
notice to Dendreon of a new PA2024 Price Election, whereupon, Kirin shall become
obligated to pay a transfer once in U.S. Dollars equal to Dendreon's
Fully-Burdened
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Manufacturing Costs of PA2024 at the time of manufacture at such greater Scale,
plus a handling fee of ten percent (10%). Prior to each PA2024 Price Election,
Kirin may notify Dendreon in writing of Kirin's good faith tentative intention
to make the election, and request a statement from Dendreon of the actual
scale-up costs to Dendreon of the scale-up to that manufacturing level. Dendreon
shall furnish Kirin with a statement of such scale-up costs no later than thirty
(30) days after Kirin requests such statement. Dendreon shall furnish Kirin, at
Kirin's request, periodic progress reports on such scale-up costs and efforts.
At the time Kirin makes a PA2024 Price Election, Kirin shall become obligated to
reimburse to Dendreon as part of the transfer price: (a) ten percent (10%) of
the documented cost (in U.S. dollars) to Dendreon of the scale-up to which the
PA2024 Price Election and purchase relates and (b) ten percent (10%) of the
documented cost (in U.S. dollars) to Dendreon of any lesser scale-up costs not
previously reimbursed by Kirin to Dendreon. The full reimbursable amount under
the preceding sentence shall be paid as part of the transfer price of the first
order placed by Kirin under the PA2024 Price Election. Kirin shall pay Dendreon
fifty percent (50%) of the transfer price for a particular order of PA2024
within thirty (30) days of placing its order for PA2024, and fifty percent (50%)
of such transfer price within thirty (30) days of delivery of the ordered
PA2024, pursuant to Section 2.4.
(b) DENDREON'S PURCHASE OF PARTICULAR KIRIN COMPONENTS. 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 twenty percent (20%). Dendreon shall pay Kirin
fifty percent (50%) of the transfer price for a particular order of Kirin
Components within thirty (30) days of placing its order for such Kirin
Components, and fifty percent (50%) of such transfer price within thirty (30)
days of delivery of such Kirin Components, pursuant to Section 2.4.
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
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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 (b) the reports of the
Audited Party's Fully-Burdened Manufacturing Costs for Components hereunder or
(c) Dendreon's claim for reimbursement of scale-up costs under Section
5.1(a)(ii). However, the Audited Party shall only be obligated to maintain and
produce records 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.
(d) 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.
(e) 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.
(f) 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
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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.
(a) 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 one million U.S.
dollars ($1,000,000) for such Dendreon 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.
(b) The Parties acknowledge that Kirin has properly
exercised its option to provide financial support for Licensed Dendreon Products
APC 8015 and APC 8020 within the meaning of Section 5.3(a) of the Agreement and
that Kirin has provided its full share of such financial support for purposes of
fixing the transfer price of the Separation Devices and PA2024.
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
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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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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
75.
entity, specifically including any failure to store or transport Dendreon
Components 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 Components 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
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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 3.9(b), 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.
77.
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
78.
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.
(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.
79.
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.
80.
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
3005 1st Avenue
Seattle, WA 98121-1010
Attention: General Counsel
Telephone: (206) 256-4545
Facsimile: (206) 256-0571
With copy to:
81.
McNaul Ebel Nawrot Helgren & Vance P.L.L.C.
One Union Square,
600 University Street, Suite 2700
Seattle, WA 98101-3143
Attention: Peter M. Vial, Esq.
Telephone: (206) 467-1816
Facsimile: (206) 624-5128
If to Kirin, addressed to:
Kirin Brewery Co., Ltd.
26-1, Jingumae 6-chome
Shibuya-ku
Tokyo 150-8011, Japan
Attention: General Manager
Planning Department
Pharmaceutical Division
Telephone: (03) 5485-6292
Facsimile: (03) 5485-6316
With a copy to:
Pennie & Edmonds LLP
1155 Avenue of the Americas
New York, NY 10036
Attention: Rory J. Radding, Esq.
Telephone: (212) 790-9090
Facsimile: (212) 869-9741
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
82.
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, unaffiliated 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 and any agreements referenced
herein set 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
83.
regard to the subject matter discussed herein. Specifically, this Agreement
supercedes and terminates the Original Supply Agreement and the Memorandum.
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
Manufacturing and Supply Agreement or any agreements referenced herein. For
clarity, a redlined version of this Agreement, showing the changes made to the
Original Supply Agreement, is attached hereto as Exhibit A. No subsequent
alteration, amendment, change or addition to this Agreement shall be binding
upon the Parties hereto unless reduced to writing and signed by the respective
authorized officers of the Parties.
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.
11.13 UNDEFINED TERMS. Terms that are capitalized but undefined in
this Manufacturing and Supply Agreement shall be defined as set forth in any
other of the Parties' Agreements (and in amendments to the foregoing
agreements). Terms that are capitalized but undefined in any amendment to this
Manufacturing and Supply Agreement shall be defined as set forth in this
Manufacturing and Supply Agreement and in any other of the Parties' Agreements
(and in amendments to the foregoing agreements). However, if there is a conflict
or inconsistency between the definition of a capitalized term appearing in this
Manufacturing and Supply Agreement or in any amendments hereto, on the one hand,
and a definition of the same capitalized term appearing in any other of the
Parties' Agreements and amendments thereto, on the other, then the definition of
the capitalized term set forth in the Collaborative License Agreement and in the
amendment hereto shall control.
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: By:
------------------------------- -------------------------------
Title: Title:
---------------------------- ----------------------------
84.
EXHIBIT A
REDLINED AGREEMENT
1.
AMENDED AND RESTATED
MANUFACTURING AND SUPPLY AGREEMENT
BETWEEN
DENDREON CORPORATION
AND
KIRIN BREWERY CO., LTD.
TABLE OF CONTENTS
Page
----
ARTICLE 1-: DEFINITIONS
1.1 "Affiliate" .............................................. 3
1.2 "Back-Up License" ........................................ 3
1.3 "Business Day" ........................................... 3
1.4 "Collaborative License Agreement" ........................ 3
1.5 "Component" or "Components" .............................. 4
1.6 "Controlled" or "Control" ................................ 4
1.7 "Dendreon Antigen" ....................................... 4
1.8 "Dendreon Component" or "Dendreon Components" ............ 4
1.9 "Dendreon Product" ....................................... 4
1.10 "Dendreon Technology" .................................... 5
1.11 "Dendritic Cell" ......................................... 5
1.12 "Effective Date" ......................................... 5
1.13 "Fully-Burdened Manufacturing Costs" ..................... 5
1.14 "Information" ............................................ 5
1.15 "Kirin Antigen" .......................................... 6
1.16 "Kirin Component" or "Kirin Components" .................. 6
1.17 "Kirin PA2024 Option" .................................... 6
1.18 "Kirin Product" .......................................... 6
1.19 "Kirin Hiring Period" .................................... 6
1.20 "Licensed Dendreon Product" .............................. 6
1.21 "Licensed Kirin Product" ................................. 6
1.22 "Manufacturing and Supply Agreement" ..................... 7
1.23 "Manufacturing Know-How" ................................. 7
1.24 "Manufacturing Plan" ..................................... 7
1.25 "Memorandum" ............................................. 7
1.26 "Net Revenue" ............................................ 7
1.27 "Non-listed Facilities" .................................. 8
1.28 "Original Supply Agreement" .............................. 8
1.29 "PA2024 Price Election" .................................. 8
1.30 "Parties' Agreements" .................................... 8
1.31 "Patent" ................................................. 8
1.32 "Product" ................................................ 8
1.33 "Purchaser" .............................................. 8
1.34 "Reagent" ................................................ 8
1.35 "Reasonable Efforts" ..................................... 9
1.36 "Research and License Agreement" ......................... 9
1.37 "Regulatory Approval" .................................... 9
1.38 The "Restated Effective Date" ............................ 9
1.39 "Scale" .................................................. 9
1.40 "Separation Devices" ..................................... 9
1.41 "Steering Committee" ..................................... 10
1.42 "Steering Committee" ..................................... 10
1.43 "Supplier" ............................................... 10
1.44 "Supplier Patent" ........................................ 10
1.45 "Third Party" ............................................ 10
ARTICLE 2: SUPPLY FOR CLINICAL DEVELOPMENT .......................... 10
2.1 Supply for Clinical Development .......................... 10
2.2 Forecasts ................................................ 11
2.3 Order Placement Procedure ................................ 11
2.4 Delivery and Risk of Loss ................................ 12
2.5 Acceptance and Rejection ................................. 13
2.6 Manufacturing Modifications .............................. 14
2.7 Restrictions on Sale ..................................... 14
2.8 Use of Separation Devices by Kirin Collaborators ......... 15
ARTICLE 3: COMMERCIAL SUPPLY ........................................ 15
3.1 Commercial Supply ........................................ 15
3.2 Preparation .............................................. 16
3.3 Forecasts ................................................ 16
3.4 Order Placement Procedure ................................ 17
3.5 Inventory ................................................ 18
3.6 Amendments ............................................... 18
3.7 Resolution of Supply Problems ............................ 18
3.8 Acceptance and Rejection ................................. 21
3.9 Kirin Manufacture of Dendreon Components ................. 22
ARTICLE 4: REGULATORY REQUIREMENTS................................... 26
4.1 Manufacturing Facilities, Equipment and Licenses ......... 26
4.2 Manufacturing Regulatory Matters ......................... 26
4.3 Product Recall Procedures ................................ 27
4.4 Documentation ............................................ 28
ARTICLE 5: FINANCIAL OBLIGATIONS .................................... 28
5.1 Purchase Prices .......................................... 28
5.2 Audit .................................................... 30
5.3 Financing the Development of Dendreon Products ........... 32
ARTICLE 6: CONFIDENTIALITY........................................... 32
6.1 Confidentiality; Exceptions .............................. 32
6.2 Authorized Disclosure .................................... 33
6.3 Survival ................................................. 34
ARTICLE 7: INTELLECTUAL PROPERTY..................................... 34
ARTICLE 8: REPRESENTATIONS AND WARRANTIES............................ 34
8.1 General .................................................. 34
8.2 Component Warranty ....................................... 34
8.3 Warranty Disclaimer ...................................... 35
ARTICLE 9: TERM AND TERMINATION...................................... 36
9.1 Term ..................................................... 36
9.2 Termination .............................................. 36
9.3 Surviving Obligations .................................... 36
9.4 Termination Without Cause ................................ 37
ARTICLE 10: INDEMNIFICATION .......................................... 37
10.1 Indemnification by Dendreon .............................. 37
10.2 Indemnification by Kirin ................................. 38
10.3 Indemnity Procedure ...................................... 39
ARTICLE 11: MISCELLANEOUS ............................................ 39
11.1 Assignment ............................................... 39
11.2 Retained Rights .......................................... 39
11.3 Force Majeure ............................................ 40
11.4 Further Actions .......................................... 40
11.5 No Trademark Rights ...................................... 40
11.6 Notices .................................................. 40
11.7 Dispute Resolution ....................................... 41
11.8 Waiver ................................................... 42
11.9 Severability ............................................. 42
11.10 Ambiguities .............................................. 43
11.11 Entire Agreement ......................................... 43
11.12 Headings ................................................. 43
11.13 Undefined Terms .......................................... 43