Exhibit 10.1
EXECUTION VERSION
DEVELOPMENT AND SUPPLY AGREEMENT
BETWEEN
GLAXOSMITHKLINE LLC
AND
DENDREON CORPORATION
EFFECTIVE AS OF
SEPTEMBER 15, 2010
 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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TABLE OF CONTENTS

                      Page No.
Article I
  Definitions     1  
 
           
Article II
  Process Implementation Phase; Additional Services     7  
 
           
Article III
  Manufacturing and Supply     9  
 
           
Article IV
  Pricing; Payments; Shipment     12  
 
           
Article V
  Testing and Quality Assurance     14  
 
           
Article VI
  Regulatory Matters     16  
 
           
Article VII
  Intellectual Property     16  
 
           
Article VIII
  Information; Access; Audit Rights     17  
 
           
Article IX
  Representations and Warranties     19  
 
           
Article X
  Liability and Indemnification     22  
 
           
Article XI
  Insurance     23  
 
           
Article XII
  Confidentiality     24  
 
           
Article XIII
  Force Majeure Event     26  
 
           
Article XIV
  Term; Termination; Remedies     27  
 
           
Article XV
  Governance     29  
 
           
Article XVI
  Miscellaneous     30  

 
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Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULES TO AGREEMENT

     
Schedule 2.1B
  Scope of Work
Schedule 2.1C
  Process Transfer Applicable Quality Standards
Schedule 2.2A
  DENDREON Equipment List
Schedule 3.1(A)
  Quality Agreement
Schedule 4.1
  Price
Schedule 5.1A
  Specifications and Release Testing
Schedule 5.1B
  Material and In-Process Tests
Schedule 5.1C
  Certificate of Analysis
Schedule 5.1D
  “GSK Release” Flow for PA2024

 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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DEVELOPMENT AND SUPPLY AGREEMENT
     This Development and Supply Agreement (this “Agreement”) is made and
entered into as of the 15th day of September 2010 (the “Effective Date”) by and
between GlaxoSmithKline LLC (“GSK”), a Delaware limited liability company and
Dendreon Corporation (“DENDREON”), a Delaware corporation. GSK and DENDREON are
sometimes referred to herein individually as a “Party” and collectively as
“Parties.”
RECITALS
     WHEREAS, each of GSK and DENDREON is a pharmaceutical company engaged in
the discovery, development, manufacture and sale of pharmaceuticals;
     WHEREAS, on December 18, 2009, the Parties executed a Heads of Agreement
(the “Heads of Agreement”), which set forth material terms and conditions of a
proposed supply arrangement between the Parties; and
     WHEREAS, to memorialize and agree to definitive terms and conditions of the
development and supply arrangement reflected in the Heads of Agreement, the
Parties desire to enter into this Agreement pursuant to which GSK will undertake
certain activities to implement, scale-up, test and validate a process for the
manufacture the Product, as defined below, and to manufacture the Product on a
commercial scale for DENDREON.
     NOW, THEREFORE, in consideration of the foregoing recitals, mutual
covenants, agreements, representations and warranties contained herein, the
Parties hereby agree as follows:
Article I
Definitions
     “Affiliate” means, with respect to any Person, any other Person, that
directly or indirectly controls, is controlled by, or is under common control
with, such Person. For such purposes, control, controlled by and under common
control with shall mean the possession of the power to direct or cause the
direction of the management and policies of an entity, whether through the
ownership of voting stock or ownership interest, by contract or otherwise. In
the case of a corporation, the direct or indirect ownership of fifty percent
(50%) or more, or the ownership percentage as required under local jurisdiction,
of its outstanding voting shares or the ability otherwise to elect a majority of
the board of directors or other managing authority of the entity shall in any
event be deemed to confer control, it being understood that the direct or
indirect ownership of a lesser percentage of such shares shall not necessarily
preclude the existence of control.
     “Batch” shall have the meaning provided in the Quality Agreement.
     “Bill of Materials” shall have the meaning provided in Schedule 4.1.
 
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Securities and Exchange Commission pursuant to a request for confidential
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     “BLA” shall mean the Biological License Application filed with the United
States Food & Drug Administration (“FDA”) for the Product and approved by the
FDA on April 29, 2010.
     “Certificate of Analysis” shall mean a document in substantially the form
set forth in Schedule 5.1C which (i) sets forth the analytical test results for
a specified Batch of Product shipped to DENDREON hereunder, and (ii) sets forth
a statement that the Product is in conformance with the BLA.
     “Change Control Procedure” shall have the meaning provided in
Section 3.1(e) of this Agreement.
     “Change in Control” shall mean the occurrence of a tender offer, stock
purchase, ownership interest purchase, other acquisition, merger, consolidation,
recapitalization, reverse split, sale or transfer of assets or other transaction
as a result of which any person, entity or group (i) becomes the beneficial
owner, directly or indirectly, of securities of a Party representing more than
fifty percent (50%) of the ownership interest of such Party or representing more
than fifty percent (50%) of the combined voting power with respect to the
election of directors (or members of any other governing body) of such Party, or
(ii) obtains the ability to appoint a majority of the Board of Directors (or
other governing body) of the Party, or (iii) obtains the ability to direct the
operations or management such Party or any successor thereto.
     “Commercially Reasonable” or “Commercially Reasonable Efforts” means the
efforts and resources which would be used (including without limitation the
promptness in which such efforts and resources would be applied) by GSK or
DENDREON, as the case may be, consistent with its normal business practices,
which in no event shall be less than the level of efforts and resources standard
in the pharmaceutical industry for a company similar in size and scope to GSK,
or DENDREON, as the case may be, with respect to the Services and commercial
manufacturing and supply contemplated by this Agreement.
     “Conformance Batch” shall mean one (1) of a series of at least three
(3) consecutive commercial-scale batches of Product manufactured to demonstrate
Process consistency and that the resulting Product meets Specifications. The
Conformance Batches shall be used for regulatory filings in the United States of
America.
     “Consent” shall mean any consent, authorization, permit, certificate,
license or approval of, exemption by, or filing or registration with, any
Governmental Body or other Person.
     “Cost Plus Basis” shall mean (i) in the case of resources provided directly
by or at the direction of GSK, the Fully Burdened Cost of such resources plus a
mark-up to cover other related operating expenses; or (ii) in the case of
materials or services provided by a third party, the actual cost of such
services or materials plus a mark-up of five percent (5%); (iii) actual travel
expenses incurred by GSK staff as permitted under GSK corporate travel policy.
     “Current Good Manufacturing Practices” or “cGMPs” shall mean all applicable
standards relating to manufacturing practices for fine chemicals, intermediates,
bulk product or finished biopharmaceutical product. For purposes of this
Agreement, cGMPs shall mean (i) the principles
 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
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detailed in the U.S. Current Good Manufacturing Practices, 21 CFR Parts 11, 210,
and 211 as may be amended, revised and updated from time to time and (ii) any
laws or regulations as may be promulgated by any Governmental Body having
jurisdiction over the manufacture of the Product, and, (iii) any guidance
documents (including but not limited to advisory opinions, compliance policy
guides and guidelines) as may be promulgated by any Governmental Body having
jurisdiction over the manufacture of the Product, which guidance documents are
being implemented within the pharmaceutical and biopharmaceutical manufacturing
industry for such Product.
     “Days” (whether or not the word is capitalized) shall mean, except where
specified otherwise, calendar days.
     “Delay Event” shall have the meaning set forth in Section 2.4(a).
     “Demonstration Batch” shall mean one (1) successful commercial-scale
production batch of Product manufactured from the Suite in accordance with
in-process criteria. A successful Demonstration Batch is defined as a batch of
the Product, meeting the criteria set forth in Schedule 5.1A.
     “DENDREON Equipment” shall have the meaning set forth in Section 2.2(a).
     “DENDREON Intellectual Property” shall mean any and all Intellectual
Property relating to DENDREON that was (i) owned or controlled by DENDREON, its
Affiliates, or its agents prior to the Effective Date, (ii) developed or
acquired solely by DENDREON or its Affiliates after the Effective Date,
(iii) any DENDREON Invention and (iv) any patentable or unpatentable Product or
Process specific know-how or innovations created during the course of practice
as part of the transfer of the Process, in the course of the Process
Implementation Phase or in the course of the Manufacturing Phase whether
created, conceived or reduced to practice solely by GSK personnel or by DENDREON
personnel or jointly, and excluding any GSK Intellectual Property or Joint
Intellectual Property.
     “DENDREON Invention” shall have the meaning provided in Section 7.2.
     “DENDREON Supplier” shall mean an approved DENDREON supplier related to the
Process.
     “Effective Date” shall mean September 15, 2010.
     “Engineering Batches” shall mean batches (complete and/or incomplete)
undertaken during the Process Implementation Phase at commercial scale in the
Suite to determine whether newly installed or modified equipment operates as
intended under process conditions.
     “Extension Fees” shall have the meaning provided in Section 2.4(a) of this
Agreement.
     “Final Release” shall have the meaning provided in Section 5.1(b)(ii) of
this Agreement.
 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     “Firm Order” shall mean the [***] of a forecast, updated quarterly, and a
binding obligation to purchase the grams of Product specified therein.
     “Force Majeure Event” shall have the meaning provided in Section 13.1 of
this Agreement.
     “Fully Burdened Cost” shall mean the employee salary plus bonus plus
benefits expenses plus allocated corporate payroll taxes.
     “Governmental Body” shall mean any nation or government, any state,
province, or other political subdivision thereof or any entity with legal
authority to exercise executive, legislative, judicial, regulatory or
administrative functions or pertaining to government in a country in the
Territory.
     “GSK Intellectual Property” shall mean any and all Intellectual Property
that was (i) owned by GSK or GSK Affiliates before or at the Effective Date,
(ii) any GSK Invention and (iii) developed or acquired solely by GSK or GSK
Affiliates, after the Effective Date, pursuant to the terms of this Agreement
and not related to the Product or not specifically related to the Process, and
excluding any DENDREON Intellectual Property or Joint Intellectual Property.
     “GSK Invention” shall have the meaning provided in Section 7.2.
     “GSK Release” shall have the meaning provided in Section 5.1(b)(i).
     “Hazardous Materials” shall mean all Materials or Waste used in or arising
from the manufacture of the Product and that is defined in, or which may be
determined to be a hazardous material under any Legal Requirements in the
Territory.
     “Hazardous Waste” shall mean waste arising from the manufacture of the
Product or which is otherwise produced through the implementation of this
Agreement, and that is defined in, or which may be determined to be Hazardous
Waste under any Legal Requirements in the Territory.
     “Implementation Price” shall mean those fees set forth on Schedule 4.1 to
be paid to GSK as consideration for the Process Implementation Phase.
     “Indemnified Party” shall have the meaning provided in Section 10.3 of this
Agreement.
     “Indemnifying Party” shall have the meaning provided in Section 10.3 of
this Agreement.
     “Intellectual Property” shall mean (i) trademarks, trademark registrations,
trademark applications, service marks, service mark registrations, service mark
applications, business marks, brand names, trade names, trade dress, names,
logos and slogans and all goodwill associated therewith; (ii) patents, patent
rights, provisional patent applications, patent applications, designs,
registered designs, registered design applications, industrial designs,
industrial design applications and industrial design registrations, including
any and all divisions, continuations, continuations-in-part, extensions,
substitutions, renewals, registrations, re-validations, reexaminations, reissues
or additions, including all patent term extensions, supplementary certificates
of protection, of or to any of the foregoing items; (iii) copyrights, copyright
registrations, copyright applications, original
 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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works of authorship fixed in any tangible medium of expression, including
literary works (including all forms and types of computer software, including
all source code, object code, firmware, development tools, files, records and
data, and all documentation related to any of the foregoing), musical, dramatic,
pictorial, graphic and sculptured works; (iv) trade secrets, technology,
discoveries and improvements, know-how, proprietary rights, formulae,
confidential and proprietary information, technical information, techniques,
inventions, designs, drawings, procedures, processes, models, formulations,
manuals and systems, whether or not patentable or copyrightable, including all
biological, chemical, biochemical, toxicological, pharmacological and metabolic
material and information and data relating thereto and formulation, clinical,
analytical and stability information and data which have actual or potential
commercial value and are not available in the public domain, each of the
foregoing as fixed in any tangible medium of expression; and (v) all other
intellectual property or proprietary rights, in each case whether or not subject
to statutory registration or protection.
     “JMC” shall have the meaning provided in Section 15.1.
     “Joint Intellectual Property” shall mean any and all Intellectual Property
relating to the Process that is developed in connection with this Agreement
jointly by DENDREON and GSK or any of their employees, Affiliates or agents as
part of the transfer of the Process, in the course of the Process Implementation
Phase or in the course of the Manufacturing Phase including any Joint Invention.
     “Joint Invention” shall have the meaning provided in Section 7.2.
     “Legal Requirements” shall mean any and all applicable local, municipal,
provincial, federal and international laws, statutes, ordinances, rules,
regulations or operating procedures now or hereafter enacted or promulgated by
any Governmental Body, including the Regulatory Acts.
     “Losses” shall mean, collectively, any and all claims, liabilities,
damages, costs, expenses, including reasonable fees and disbursements of counsel
(except as herein limited) and any consultants or experts and expenses of
investigation, obligations, liens, assessments, judgments, fines and penalties
imposed upon or incurred by an Indemnified Party.
     “Manufacturing Phase” shall mean the period of time immediately following
the Process Implementation Phase, during which GSK shall manufacture and supply
to DENDREON mutually agreed upon quantities of Product for human clinical trial
and commercial use. For the avoidance of doubt, the Manufacturing Phase shall be
deemed to have commenced upon the successful completion of the three
(3) Conformance Batches.
     “Materials” shall mean (i) all raw materials, filters, non-inventory
materials, resins, supplies, components, work-in-process and other ingredients
required for the manufacture of Product, (ii) all packaging materials used in
the manufacture, storage and shipment of Product as further described in
Schedule 4.1.
     “Nonconformity” shall have the meaning set forth in the Quality Agreement.
 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
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     “Party” and “Parties” shall have the meanings given such terms,
respectively, in the first paragraph of this Agreement.
     “Person” shall mean any individual or corporation, company, partnership,
trust, incorporated or unincorporated association, joint venture or other entity
of any kind.
     “Person in the Plant” or “PIP” shall have the meaning provided in
Section 8.5 of this Agreement.
     “Process” shall have the meaning provided in Section 2.1 of this Agreement.
     “Process Implementation Phase” shall mean the period of time during which
GSK shall undertake activities necessary to implement, scale-up, test and
validate the Process in GSK’s manufacturing facility, including the successful
manufacture of a Demonstration Batch and the three (3) Conformance Batches, so
as to permit the manufacture of Product on a commercial scale. The Process
Implementation Phase shall be deemed complete upon the successful manufacture of
three (3) consecutive Conformance Batches.
     “Product” shall mean purified bulk component of PA2024, a recombinant
prostate antigen. The Product is a raw material used in the manufacture of
sipuleucel-T, DENDREON’s cancer immunotherapy marketed as PROVENGE® pursuant to
the BLA.
     “Quality Agreement” shall have the meaning provided in Section 3.1(A) of
this Agreement.
     “Regulatory Acts” shall mean, as applicable, the United States Federal
Food, Drug and Cosmetic Act, as amended, the rules and regulations thereunder,
and any applicable laws and regulations governing the approval, manufacture,
sale or licensing of sipuleucel-T or ingredients for inclusion therein of any
other jurisdiction in the Territory for which GSK is then producing Product.
     “Regulatory Authorities” shall mean any division of the United States Food
and Drug Administration (as applicable) and any other applicable counterpart
agency that administers the Regulatory Acts of any jurisdiction in the
Territory.
     “Scope Change” shall mean any change to the Scope of Work.
     “Scope of Work” shall have the meaning provided in Schedule 2.1B of this
Agreement.
     “Services” shall have the meaning provided in Section 2.1 of this
Agreement.
     “Specifications” shall mean, with respect to any Product, the
specifications set forth on Schedule 5.1A to this Agreement.
     “Suite” shall mean an appropriate portion of the capacity of Building 40,
Suite 3 located at GSK’s Biopharmaceutical facility in Upper Merion,
Pennsylvania.
     “Term” shall have the meaning provided in Section 14.1 of this Agreement.
 
[***] Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
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     “Territory” shall mean the United States of America and its territories and
possessions.
     “Third Party” shall mean any person or entity other than the Parties or
their respective Affiliates.
     “Waste” shall mean all wastes which arise from the manufacture of the
Product hereunder or which is otherwise produced through the implementation of
this Agreement and, for greater certainty, shall include Hazardous Waste.
Article II
Process Implementation Phase; Additional Services
     2.1 Process Implementation and Testing.
     (a) On or about December 18, 2009 (the “HOA Effective Date”), DENDREON
began the process to provide all necessary technical information in a timely
manner to GSK, including applicable DENDREON Intellectual Property and other
technical information relating to the process and testing reasonably required to
produce the Product (the “Process”), including, without limitation, cell lines
and virus banks and associated documentation. GSK shall reserve Suite capacity
and the allocated supporting plant infrastructure for the Suite necessary to
implement and maintain the Process at the Suite and manufacture the Product. GSK
shall also provide to DENDREON technical transfer services for all validated
analytical assays (except externally contracted testing as specified in
Schedule 5.1B) that are required to release the Product for further manufacture.
DENDREON shall identify a qualified primary laboratory to support analytical
technical transfer to GSK for the validated analytical assays listed in
Schedule 5.1B. Any optimization or validation of assays by GSK at the request of
DENDREON will be managed as a Scope Change.
     (b) GSK shall use Commercially Reasonable Efforts to implement, scale-up,
test and qualify the Process in the Suite. The services and tasks to be
completed by GSK in connection with the implementation, scale-up, testing and
validation of the Process in the Suite (the “Services”) are set forth in
Schedule 2.1B.
     (c) The Process Implementation Phase shall be completed in accordance with
the standards set forth in Schedule 2.1C.
     2.2 Capital Expenditures and Maintenance.
     (a) Promptly after the HOA Effective Date, GSK shall order, install and
maintain the capital equipment specified in Schedule 2.2A (“DENDREON
Equipment”). DENDREON shall reimburse GSK for capital modifications to GSK-owned
equipment required to implement the Process, pursuant to advance approval by the
JMC. DENDREON shall reimburse GSK, at cost, for all such capital expenditures
related to the implementation, scale-up, testing and validation of the Process.
 

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Securities and Exchange Commission pursuant to a request for confidential
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     (b) Title to all DENDREON Equipment shall be retained by DENDREON during
the Term of the Agreement; provided however, that all capital equipment not
designated as “portable” DENDREON Equipment on Schedule 2.2A shall remain with
GSK upon termination of this Agreement, at which time title shall pass to GSK.
DENDREON shall maintain insurance coverage at its own expense for any DENDREON
Equipment during the Term and DENDREON shall bear the risk of loss with respect
to any such DENDREON Equipment during the Term, except to the extent such loss
results solely from GSK’s negligence or GSK’s willful misconduct. GSK shall be
responsible for any routine maintenance as well as any non-routine maintenance
that becomes necessary due to GSK’s negligence or GSK’s willful misconduct.
DENDREON shall be responsible for any incremental non-routine maintenance
expenses or capital expense for the replacement or repair of DENDREON Equipment;
provided, however, that if GSK uses DENDREON Equipment for purposes other than
the Services (“GSK Purpose”), then GSK and DENDREON shall share the cost of any
incremental non-routine maintenance expenses for the specific DENDREON Equipment
used by GSK for GSK Purpose and such cost shall be shared based on a pro-rata
basis measuring the time such equipment has been used for GSK Purpose as
compared to the time used to perform Services under this Agreement. GSK shall
notify DENDREON prior to the performance of any non-routine maintenance not
caused by GSK’s negligence or GSK’s willful misconduct, and DENDREON shall
directly pay or promptly reimburse GSK (as the case may be) for any such
maintenance costs that DENDREON has authorized. During the Term, DENDREON
Equipment that is integrally part of equipment in the Suite or an integral part
of the Suite infrastructure and not readily severable may be used by GSK for
purposes other than the Services provided under this Agreement, provided
however, that such use shall not impact GSK’s ability to provide the Services
under this Agreement or the manufacture of the Product in accordance with the
Specifications.
     2.3 Reservation of Capacity.
     Subject to Section 3.1(b) and subject to any acceptance of a Firm Order by
GSK, the Parties agree that during the Term, GSK shall reserve an appropriate
portion of the capacity of the Suite to meet DENDREON’s forecast demand for
Product. The Suite consists of [***], purification capacity sized to meet output
from the production bioreactors, and supporting infrastructure. GSK and DENDREON
have mutually agreed based on the information provided by DENDREON, that at
[***] will be necessary in the Suite with matching downstream processing. GSK
acknowledges that in consideration for GSK reservation of capacity DENDREON has
paid GSK the reservation fee described in the Heads of Agreement.
     2.4 Delay in the Process Implementation Phase; Failure to Implement
Process.
     (a) If a Delay Event occurs (as defined below) and DENDREON elects to have
GSK continue efforts to implement the Process and/or Process Implementation
Phase for a maximum of up to [***], then DENDREON shall commence paying GSK a
fee of [***] per calendar month during such extension period (the “Extension
Fee”). Payment of the Extension Fee shall be on a pro rata basis for any
calendar month that is not a full calendar month. For the avoidance of doubt, no
other fees shall be due to GSK during the mutually agreed extension period, with
the exception of the fees associated with Materials set forth in Schedule 4.1
and externally contracted testing services. The term “Delay Event” shall mean
any event that causes performance of Process
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
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Implementation Phase obligations to extend beyond [***]. For the avoidance of
doubt, a Delay Event shall exclude any event that extends Process Implementation
Phase completion beyond [***] caused solely by GSK’s action or inaction.
     (b) [***]
     2.5 Additional Services.
     DENDREON, may at any time during the Term, request that GSK perform
additional services, implement changes to the Process that are necessary to
conform to regulatory requirements or improve the Process efficiency. DENDREON
shall pay additional fees to GSK for additional services as set forth in this
Agreement or for services not specified in the Scope of Work. All such
additional services shall be defined and mutually agreed in a Scope Change
document, outlining the service to be provided and associated additional costs
and timelines for completion, as further described in Schedule 2.1B of the Scope
of Work, entitled, “Change Management Mechanism.” GSK shall invoice DENDREON for
all such additional services or Scope Changes on a Cost Plus Basis. DENDREON
shall provide reasonable ongoing technical assistance to GSK in connection with
the Services to be provided hereunder to ensure that mutually agreed upon
milestones are achieved in a timely manner. Notwithstanding the foregoing, GSK
shall have no obligation to implement any change or improvement which adversely
impacts GSK’s ability to manufacture its own or a third party’s products in the
Building 40 facility. For the avoidance of doubt, GSK shall be entitled to an
adjustment of the pricing for Services to recover expenses incurred by GSK due
to any such changes or improvements which adversely impact GSK’s operating
costs, which adjustment shall be negotiated by the Parties in good faith. If any
Governmental Body requires GSK to implement any changes or improvements
necessary to permit GSK to manufacture the Product, the Parties shall discuss
such changes or improvements and the costs associated therewith at the JMC.
     2.6 Failure to Deliver Materials and Process Information.
     In addition to the covenants set forth in Section 2.4(a), if during the
Process Implementation Phase, DENDREON fails to timely deliver Materials and
information to GSK thereby interfering with GSK’s ability to meet the target
completion dates for the milestones set forth in Schedule 2.1B, or initiates a
Scope Change that adversely impacts GSK’s ability to meet the target completion
dates for the milestones, then DENDREON shall nevertheless pay the fees for the
Process Implementation Phase as set forth in Schedule 4.1.
     2.7 Continuous Improvement Program. The JMC shall oversee a continuous
improvement program to improve the efficiency and/or productivity of the
Process. All net cost savings resulting from such joint activities shall be
shared equally between the parties.
Article III
Manufacturing and Supply
     3.1 Manufacture of Product; Purchase of Product.
 

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     (a) Upon completion of the Process Implementation Phase, GSK shall commence
the Manufacturing Phase. During the Manufacturing Phase, GSK shall manufacture
Product in accordance with all applicable regulatory requirements necessary to
support the approval of DENDREON’S BLA and maintain the BLA in accordance with
applicable quality standards for the Product as set forth in the Quality
Agreement (attached hereto as Schedule 3.1A); applicable health and safety
requirements; and the Specifications. GSK shall manufacture Product for both
commercial sale and for use in any human clinical trials initiated by DENDREON
in the Territory, respectively. DENDREON may request Product be manufactured for
use in clinical trials and/or commercial sale outside the Territory, and the
Parties will in good faith discuss the requirements and costs associated
therewith. Any such changes to the Territory would be defined and mutually
agreed upon in a Scope Change document, outlining the requirements and
specifications, and any additional cost.
     (b) In no event shall GSK be required to manufacture more Product than
commercially possible based on the demonstrated Process capability or forecasted
by DENDREON and accepted by GSK. From time to time, due to significant
unforeseen circumstances, DENDREON may deliver to GSK an order for Product
volumes in excess of those specified in any Firm Order. Upon DENDREON’s written
request, GSK shall use its Commercially Reasonable Efforts to provide DENDREON
with such additional Product volumes, but shall not be obligated to do so if
accommodating DENDREON would adversely impact GSK.
     (c) Purchase of Product. DENDREON shall purchase Product from GSK on a
nonexclusive basis and in accordance with the assumptions set forth on
Schedule 4.1.
     (d) Specifications Change.
          (i) Either Party may request a Specifications change. The Parties
shall discuss in good faith the implementation of any such requested change;
provided however, that any such change shall be made only upon the mutual
consent of both Parties. Either Party may request a Specifications change that
is required for compliance with Regulatory Acts or Legal Requirements, which
consent shall not be unreasonably withheld or delayed. All such changes in
Specifications shall be implemented in accordance with the Change Control
Procedure.
          (ii) GSK shall not make any revisions to the Specifications without
prior written consent of DENDREON.
          (iii) Prior to implementation of any change to the Specifications, the
Parties shall agree upon a procedure to ensure that applicable Governmental
Bodies have approved the change to the Specifications (to the extent necessary),
and that GSK has a reasonable period of time to implement any changes required
by any such applicable Governmental Body with regard to the Specifications.
          (iv) DENDREON shall be responsible for the cost of any Specifications
change which is: (A) requested by DENDREON; or (B) required by Regulatory Acts
or Legal Requirements which relate solely to the Process; or (C) required due to
a change of any DENDREON Supplier. GSK shall be responsible for the cost of any
Specifications change which
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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is requested by GSK, is not required by Regulatory or Legal Requirements and
which relates solely to the Process.
     (e) Change Control Procedure. The Change Control Procedure set forth in the
Quality Agreement (the “Change Control Procedure”), shall establish the
procedure to be followed if either GSK or DENDREON desires to change any aspect
of the Process or the Product, including but not limited to, any change in
Specifications (each a “Change Control”). All Change Control requests that have
either a cost impact for which DENDREON is responsible or a schedule impact
shall also be accompanied by a Scope Change request form outlining the costs and
timing to implement such changes.
     (f) Validation Requirements. GSK shall perform at no additional cost to
DENDREON and on an on-going basis the necessary validation activities required
by cGMPs or Legal Requirements in connection with the regular course of
manufacturing the Product as further described in the Quality Agreement. For the
avoidance of doubt, any DENDREON request that GSK revalidate an assay shall be
deemed to be a Scope Change.
     3.3 Forecasts and Firm Orders.
     On the Effective Date, DENDREON shall provide GSK with a [***] non-binding
rolling forecast of its Product requirements for the purpose of facilitating
GSK’s capacity allocation and production planning efforts. DENDREON shall submit
an updated forecast on or before the first business day of each subsequent
calendar quarter. The [***] of each forecast shall be deemed a Firm Order. Each
[***] shall specify target Product requirements for each calendar quarter in the
[***]. Unless otherwise agreed by the Parties, [***] and in accordance with
other parameters set forth herein.
     Each Firm Order shall be accepted or rejected pursuant to written notice
delivered to DENDREON within five (5) business days of receipt by GSK of the
applicable forecast. Any Firm Order that is accepted by written notice or is
deemed accepted because GSK did not either accept or reject the Firm Order in
writing within five (5) business days of GSK’s receipt of the same shall be
binding on each Party. In the event that GSK rejects a Firm Order pursuant to
this Section 3.3, GSK shall (i) communicate with DENDREON the reasons that it is
unable to satisfy such Firm Order, and (ii) the Parties may meet to discuss
potential modification of the Firm Order that may result in GSK’s acceptance of
such Firm Order.
     3.4 Failure to Deliver Cell Banks, Virus Banks, Critical Reagents,
Information to Close Batch Deviations or Reference Standard.
     In the event that during the Manufacturing Phase DENDREON fails to deliver
the cell bank, virus banks, critical reagents, information to close Batch
deviations or reference standards that are necessary for the manufacture and/or
release of the Product and such failure adversely impacts GSK’s ability to
manufacture and/or release Product, GSK shall nevertheless be entitled to
payment on the basis of the Firm Orders accepted by GSK. In the event that
forty-two (42) calendar days after a Batch of Product has been filled into final
containers and GSK is unable to complete the GSK Release of the Batch due to
actions or inactions by DENDREON as described in
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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this Section 3.4, then GSK shall be entitled to invoice DENDREON for such Batch
without having completed a GSK Release and DENDREON shall be obligated to pay
such invoice pursuant to Section 4.3.
Article IV
Pricing; Payments; Shipment
     4.1 Pricing
     (a) The price for the Process Implementation Phase (the “Implementation
Price”), excluding materials, supplies and external laboratory testing reflected
in the Bill of Materials for the Product, is set forth in Schedule 4.1. DENDREON
shall pay each of the amount(s) set forth in Schedule 4.1 pursuant to
Section 4.3. The Extension Fees set forth in Schedule 4.1 shall be due and owing
only if the Process Implementation Phase is extended beyond [***], pursuant to
Section 2.4.
     (b) Indicative pricing for the manufacture of Product (the “Price”),
excluding materials and supplies reflected in the Bill of Materials for the
Product, is set forth in Section B of Schedule 4.1. The Price, excluding
materials and supplies reflected in the Bill of Materials, shall be adjusted by
the Parties following completion of the Process Implementation Phase, and shall
be based upon the demonstrated performance of the Process during the Process
Implementation Phase.
     (c) The Price shall be deemed to be effective as of the Effective Date, and
shall be subject to annual increases for inflation based on increases in the
Producer Price Index (“PPI”) for pharmaceutical preparation manufacturing over
the twelve (12) month period since the previous Price adjustment. If GSK’s
actual cost increases exceed such increase in the PPI, GSK will provide
substantiation of such actual cost increases and the Parties will negotiate in
good faith to agree upon an increase for inflation in excess of the PPI
increase.
     4.2 Invoices. All invoices for the Price of the Product, and expenses
related thereto covered hereunder, shall be submitted by GSK to DENDREON for
each Batch of Product upon completion of the GSK Release. DENDREON shall pay
undisputed invoices within thirty (30) days of receipt of the invoice. In the
event that there is a dispute with respect to all or part of an invoice,
DENDREON shall pay the portion of the invoice that it does not dispute within
thirty (30) days, and the disputed portion shall be subject to the dispute
resolution process to be specified herein.
     4.3 Payment. DENDREON shall pay GSK the amounts set forth on invoices
submitted to DENDREON by GSK on or before thirty (30) days after the date of
invoice, except for any amounts disputed in good faith. Payments that are not
paid within thirty (30) days of the date on which they were due shall accrue
interest at one percent (1.0%) per month or portion thereof from the date
payment was due. No interest will be charged on such amounts during the period
of any dispute; provided however, that interest will be paid to GSK in the event
GSK prevails in the dispute.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     4.4 Payment Denominations. All payments to be made under this Agreement
shall be made in United States Dollars unless otherwise agreed by the Parties.
     4.5 Credits for Non-conforming or Defective Product. In the event
(i) DENDREON rejects a Batch of Product received hereunder because it contains a
latent defect as further described in Section 5.2(a); (ii) DENDREON never
receives a Batch of Product because GSK was unable to issue a Certificate of
Analysis for such Batch and perform a Final Release; or (iii) the Parties agree
that the Product is non-conforming pursuant to the procedures set forth in the
Quality Agreement, GSK shall issue a credit to DENDREON for any amounts
previously paid for said Batch against payments owed for any future batches. In
the event the Parties disagree as to whether the Product is conforming, the
matter shall be referred to the JMC for resolution.
     4.6 Taxes.
     (a) DENDREON shall pay and otherwise be responsible for all applicable
sales, goods and services and transfer taxes in connection with any payment made
by DENDREON pursuant to this Agreement.
     (b) Any income or other tax that one Party is required to withhold and pay
on behalf of the other Party with respect to amounts payable under this
Agreement shall be deducted from and offset against said amounts prior to
payment to the other Party; provided however, that in regard to any tax so
deducted, the Party making the withholding shall give or cause to be given to
the other Party such assistance as may reasonably be necessary to enable that
other Party to claim exemption therefrom or credit therefor, and in each case
shall furnish the Party on whose behalf amounts were withheld, proper evidence
of the taxes paid on its behalf. Each Party shall comply with reasonable
requests of the other Party to take any proper actions that may minimize any
withholding obligation.
     4.7 Shipment/Testing/Rejection.
     (a) Shipment. GSK shall deliver Product to DENDREON EXW (Building 40, Upper
Merion, Pennsylvania) Incoterms 2000 except with regard to title and risk of
loss, which are described below. DENDREON shall arrange for shipping at
DENDREON’s expense.
     (b) Title; Risk of Loss. Title to the Product shall pass from GSK to
DENDREON upon the later of the following: (1) the date that GSK issues an
invoice to DENDREON for the Product, or (2) the date GSK releases Product to
DENDREON by providing DENDREON with a Certificate of Analysis. Risk of loss
shall pass from GSK to DENDREON upon the earlier of the following: (1) the time
Product is received by DENDREON’s carrier or freight forwarder or (2) thirty
(30) days after Product is released to DENDREON by providing DENDREON with a
Certificate of Analysis. DENDREON shall be responsible for obtaining its own
insurance for Product in transit between GSK and DENDREON facilities or
DENDREON’s designated secondary finishing facility, as may be applicable.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     (c) Storage. GSK shall store released Product at no charge to DENDREON for
a maximum of thirty (30) days, after which GSK shall be entitled to charge a
monthly storage fee set forth in Schedule 4.1.
Article V
Testing and Quality Assurance
     5.1 Product.
     (a) Manufacture to Specifications. GSK shall supply Product that meets the
Specifications set forth in Schedule 5.1A and shall perform in-process and
release testing required to perform the GSK Release and Final Releases of the
Product to DENDREON as more fully described in the Quality Agreement. For the
avoidance of doubt, release testing requirements shall mean those standard tests
normally associated with a biopharmaceutical product as set forth in
Schedule 5.1A. Any testing in addition to the tests specified in Schedule 5.1A
is subject to the JMC’s approval, and shall be deemed a Scope Change and handled
in accordance with the procedures set forth in Section 2.5.
     (b) GSK Release and Final Releases of Product.
          (i) GSK shall: (A) perform in-process and release testing as required
in the Quality Agreement and as set forth in Schedule 5.1A and 5.1B, and
(B) determine that each Batch meets the Specifications set forth in
Schedule 5.1A and shall provide DENDREON with the Certificate of Analysis with a
conformance statement as set forth in Schedule 5.1C and other documentation
required in the Quality Agreement in order to complete a Final Release of each
Batch of Product (the “GSK Release”). The GSK Release Flow for PA2024 is set
forth in Schedule 5.1D.
          (ii) Subject to DENDREON’s rights under Section 5.2, upon receipt of
the GSK Release documentation, DENDREON shall review and approve the GSK Release
documentation and provide final release notification to GSK within five
(5) business days of receipt (the “Final Release”). Upon completion of the Final
Release, GSK shall tender delivery of Product to DENDREON’s designated carrier
or freight forwarder at the Suite and the risk of loss for such Product shall
pass from GSK to DENDREON as more fully described in Section 4.7(b). DENDREON
shall be responsible for performing its own release of Product for further
manufacture.

5.2   Holds and Rejections.

     (a) General. DENDREON shall be entitled to sample and test the Product to
determine that the Product meets the agreed Specifications. Within thirty
(30) days after such sampling and testing or DENDREON’s receipt of Product or
samples for testing, DENDREON shall notify GSK if: (i) DENDREON places any
Product on hold for further investigation of any Nonconformity discovered by
DENDREON; or (ii) DENDREON prepares a Deviation Report (as defined in the
Quality Agreement) with respect to a Batch; or (iii) DENDREON rejects any Batch
(or portion thereof) of Product. DENDREON’s notice shall state the basis for the
hold, Deviation Report or
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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rejection. In the case of a latent defect in a Batch of Product which could not
be discovered by DENDREON during its release testing procedures, DENDREON shall
notify GSK of such latent defect within thirty (30) days after its discovery by
DENDREON. In either case, DENDREON’s failure to provide such notice within the
thirty (30) day period shall be deemed an acceptance of the Product or samples
delivered.
     (b) Independent Testing. If the Parties disagree as to whether the Product
subject to a hold, Deviation Report or rejection meets Specifications,
DENDREON’s quality assurance officer designated by DENDREON from time to time
and GSK’s Director of Quality in GMS Biopharmaceuticals, shall confer to review
samples, testing, Batch records and or other relevant documentation in an effort
to resolve the Parties’ disagreement. If the disagreement is not resolved, then
samples, Batch records and other data relating to the Batch in dispute shall be
promptly submitted for testing and evaluation to an independent Third Party
(including a testing laboratory) approved in writing by both Parties. The
conduct of such testing and evaluation and the conclusions and recommendations
issued by the independent Third Party shall comply with cGMP requirements. The
cost of the Third Party testing and evaluation shall be borne by DENDREON if the
independent Third Party determines that the Product meets Specifications and by
GSK if the independent Third Party determines that the Product does not meet
Specifications.
     (c) Notice. In the event that after the Final Release of the Product,
either Party becomes aware that any Batch of the Product may have a
Nonconformity, such Party shall immediately notify the other Party.
     5.3 Certain Product Events. In the event that DENDREON is required by a
Governmental Body or Regulatory Authority or voluntarily decides to initiate a
recall, withdrawal or field correction of, field alert report or comparable
report with respect to, any product incorporating Product manufactured by GSK
pursuant to this Agreement, DENDREON shall notify GSK and GSK shall fully
cooperate with DENDREON to implement the same. DENDREON shall make all contacts
with Regulatory Authorities and shall be responsible for coordinating all of the
necessary activities in connection with any such recall, withdrawal or field
correction, field alert report or comparable report, and shall make all
statements to the media, including, but not limited to press releases and
interviews for publication or broadcast. GSK agrees to make no statement to the
media, Governmental Body or Regulatory Authority, unless otherwise required by
law, and in such event, GSK shall collaborate with DENDREON on the content of
any such statement, but only to the extent permitted by Legal Requirements
and/or Regulatory Acts. GSK shall be free to make contacts with Regulatory
Authorities and Governmental Bodies relating to the Suite generally or other
products manufactured in the Suite. DENDREON shall be responsible for all costs
associated therewith unless the recall, withdrawal, or field correction, field
alert report or comparable report is initiated because of a defect in the
Product arising from GSK’s gross negligence or intentional misconduct in the
manufacture of the Product by GSK in which case GSK will pay for out-of-pocket
costs and administrative costs actually incurred by DENDREON to Third Parties
for transportation and destruction of the recalled product incorporating the
Product upon receipt of substantiation of such costs. GSK will notify DENDREON
of any new product developments or introductions or any changes to the Suite
that may have a significant impact on the Product.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     5.4 Quality Agreement. The Quality Agreement (attached hereto in Schedule
3.1A) specifies the respective quality assurance obligations and
responsibilities of the Parties with respect to the manufacture of the Product.
Notwithstanding anything to the contrary in this Agreement or in any other
document or agreement, in the event of a conflict between this Agreement and the
Quality Agreement, the Quality Agreement shall govern and control as to matters
involving compliance with cGMP, Legal Requirements and/or Regulatory Acts.
Article VI
Regulatory Matters
     6.1 Manufacturing Consents. As part of the Services, GSK shall provide
DENDREON with information and documentation that may be necessary for DENDREON
to obtain and maintain necessary regulatory approvals required by FDA for GSK’s
manufacture of the Product for use in products manufactured for human clinical
trials and/or commercial sale by DENDREON. GSK shall provide reasonable and
timely assistance and support to DENDREON that may be necessary for DENDREON to
obtain such approval. GSK shall be responsible for maintaining proper
documentation for the manufacture of the Product in accordance with applicable
laws and regulations.
     6.2 Product Consents. DENDREON shall, at its expense, obtain and maintain
any Consents which may from time to time be required by any Governmental Body or
Regulatory Authority with respect to the BLA or with respect to the marketing,
distribution, clinical investigation, import or export of sipuleucel-T. DENDREON
shall be responsible for responding to all requests for information related to
such Consents made by, and making all legally required filings relating to such
Consents with, any Governmental Body or Regulatory Authority having jurisdiction
to make such requests or require such filings. In the event any material Consent
held by DENDREON related to the FDA’s approval of the BLA is suspended or
revoked, DENDREON shall promptly notify GSK of such suspension or revocation.
Article VII
Intellectual Property
     7.1 Ownership.
     (a) GSK Rights. DENDREON acknowledges and agrees that, as between GSK and
DENDREON, GSK owns all rights in and to the GSK Intellectual Property.
     (b) DENDREON Rights. GSK acknowledges and agrees that, as between GSK and
DENDREON, DENDREON or its Affiliates owns all rights in and to the DENDREON
Intellectual Property.
     7.2 New Developments and Modifications. With respect to inventions and
intellectual property made pursuant to work performed under this Agreement
relating either directly or indirectly to the Product, made by either GSK or
DENDREON employees or agents individually or jointly, such patentable or
unpatentable process or product shall be owned by DENDREON (each, a “DENDREON
Invention”). Title to all inventions and intellectual property made solely by
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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GSK employees or agents without inventive contribution from DENDREON and its
Affiliates employees or agents and which do not specifically relate to the
Product or the Process shall be owned by GSK (each, a “GSK Invention”). With
respect to inventions and intellectual property made pursuant to work performed
under this Agreement relating specifically to the Process, made by GSK employees
or agents individually or GSK and DENDREON employees or agents jointly, and
which do not relate to the Product shall be owned jointly by GSK and DENDREON
(each, a “Joint Invention”). Title to each Joint Invention shall be owned
jointly by GSK and DENDREON. Inventorship of inventions and other intellectual
property rights conceived and/or reduced to practice in connection with the
development activities hereunder shall be determined in accordance with the
patent laws of the United States. Both Parties agree to provide all required or
requested assistance to the other Party in obtaining and enforcing the full
benefits, enjoyment, rights and title throughout the world to a DENDREON
Invention, GSK Invention or Joint Intellectual Property, including but not
limited to the review and execution of assignments confirming ownership,
declarations, powers of attorney, and other documents, and assistance or
cooperation in legal proceedings. Each Party will be reasonably compensated by
the other Party for their time spent in rendering such assistance, except that
no additional compensation will be paid for the execution of documents.
     7.3 Grant of Licenses.
     (a) DENDREON License Grant. During the Term of this Agreement, DENDREON
hereby grants GSK a non-exclusive, non-transferable (except to an Affiliate
obtaining title to the GSK Building 40 facility), royalty-free, worldwide
license or sublicense of the DENDREON Intellectual Property related to the
Process and applicable manufacturing technology, and the right to utilize the
DENDREON Intellectual Property and DENDREON Inventions as may be necessary
solely to (i) engage in the transfer of the Process and related analytical
methods, and (ii) perform the Services and manufacture the Product on behalf of
DENDREON, to the extent that but for such license or sublicense GSK’s
implementation of the Process would infringe DENDREON’s or a Third Party’s
rights.
     (b) Cross-license Grant. Both Parties hereby grant to the other Party a
non-exclusive, transferable, sub-licensable, perpetual, royalty-free, worldwide
license to the Party’s interest in and to Joint Intellectual Property.
     (c) No Other License. Except as stated herein, neither Party shall be
deemed to have granted to the other Party any license, sublicense or other right
to any patent, trade secret, innovation or know-how held by such Party prior to
the Effective Date or that has been discovered or developed without reference to
the other Party’s Confidential Information as defined in Article XII.
Article VIII
Information; Access; Audit Rights

8.1   Provision of Information. GSK shall provide to DENDREON copies (in
electronic or hard-copy form, as requested by DENDREON and as mutually agreed
between the Parties) of all data, records and information related to the Process
or Product generated during the Term as

 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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may be requested from time to time by DENDREON. The Parties shall meet to review
mutually agreed upon metrics on a quarterly basis, or such longer period as
agreed by the Parties.
     8.2 Audit and Inspection Rights.
     (a) EHS and Insurance Audit Rights. DENDREON shall have the right to once
per calendar year audit and inspect those portions of the Suite used in the
manufacture, generation, storage, testing, treatment, holding, transportation,
distribution or other handling or receiving of the Product and Materials, for
purposes related to insurance of the equipment, quality and/or an environmental,
health and safety audits and inspection.
     (b) Quality Audit and Inspection Rights. DENDREON shall have the right to
once per calendar year, as otherwise permitted in the Quality Agreement, or more
frequently if there is cause, and as otherwise set forth in the Quality
Agreement, audit and inspect those portions of the Suite used in the
manufacture, generation, storage, testing, treatment, holding, transportation,
distribution or other handling or receiving of the Product and Materials, for
purposes including but not limited to any insurance and/or environmental, health
and safety audits and inspections and conformance with the Specifications.
DENDREON shall have the right to audit and inspect all inventory of Product and
Materials contained at the Suite.
     (c) Procedure for the Conduct of Audits and Inspections. The dates and
duration of any audit or inspection conducted pursuant to Section 8.2(a) or
(b) shall be mutually agreed in advance, except as otherwise provided under the
Quality Agreement. Such audits or inspections shall occur during normal business
hours and shall be requested by DENDREON at least five (5) business days in
advance. DENDREON’s audit and inspection rights under this Section shall not
extend to any portions of the Suite, documents, records or other information
which do not relate to the Product or Materials. In the event that Third Party
information is included in materials that are otherwise subject to DENDREON
review, GSK may redact information relating to Third Parties and their
respective product or materials from any documents disclosed to DENDREON in
connection with DENDREON’s exercise of its audit and inspection rights.
     8.3 Financial Review. Once each calendar year, or more frequently if there
is cause, DENDREON shall upon reasonable advance notice and during regular
business hours have the right to perform a complete physical inventory of all
DENDREON Equipment, Materials and Product located in the Suite.
     8.4 Documentation. Each Party shall maintain, in accordance with and for
the period required under cGMPs, Legal Requirements and/or Regulatory Acts and
complete and adequate records pertaining to the methods and facilities used for
compliance with cGMPs, and manufacture, processing, and testing of the Product.
     8.5 Person in the Plant. During the Term, DENDREON shall be entitled to
maintain up to two (2) Persons in the Plant (“PIP”) and any additional PIPs as
may be otherwise mutually agreed upon by the Parties, to observe the Process
Implementation Phase and the Manufacturing Phase. The responsibilities of the
PIP shall include, but not be limited to: (a) acting as liaison for
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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DENDREON Quality Assurance and the DENDREON technical transfer team members;
(b) performing the functions described in the Quality Agreement required to
support technical and quality assurance operations; and (c) participation in
Change Control activities, atypical event and deviation resolution meetings
related to the Product. GSK shall provide the PIPs reasonable office space
within the Suite during regular working hours.
Article IX
Representations and Warranties
     9.1 Representations and Warranties of GSK. Throughout the Term, GSK
represents and warrants that:
     (a) Status; Enforceability. GSK is a validly existing limited liability
company in good standing under the laws of Delaware; the execution, delivery and
performance of this Agreement by GSK has been duly authorized by all requisite
limited liability company governance; this Agreement constitutes a legal, valid
and binding obligation of GSK, enforceable against GSK in accordance with the
terms hereof, subject to the effect of bankruptcy, insolvency, reorganization,
receivership, moratorium and other similar laws affecting the rights and
remedies of creditors generally and the effect of general principles of equity,
whether applied by a court of law or equity; and the execution, delivery and
performance of this Agreement by GSK will not violate or conflict with any other
agreement or instrument to which GSK is a Party.
     (b) Intellectual Property. To GSK’s knowledge, the GSK Intellectual
Property licensed to DENDREON pursuant to Article VII is free and clear of any
lien, encumbrance, security interest or restriction on license inconsistent with
the rights granted to DENDREON herein.
     (c) Certain Persons. GSK will not use, in any capacity associated with or
related to the manufacture of the Product, the services of any persons who have
been, or are in the process of being, debarred under 21 USC § 335a(a) or (b) or
any comparable Regulatory Act. Furthermore, neither GSK nor any of its officers,
employees, or consultants has been convicted of an offense under (i) either a
federal or state law that is cited in 21 USC § 335(a) as a ground for debarment,
denial of approval, or suspension, or (ii) any other law cited in any comparable
Legal Requirement as a ground for debarment, denial of approval or suspension.
     (d) cGMPs Training. GSK shall appropriately educate and train all of its
employees performing work under this Agreement related to cGMPs and ensure that
such practices are followed by its employees.
     (e) Hazardous Materials and Waste Training. GSK shall appropriately educate
and train all employees performing work under this Agreement regarding the
potential hazards associated with the handling of Hazardous Materials and Waste
and the manufacturing, processing, packaging, analyzing and handling of the
Materials and the manufacture of the Product, and on the proper use of
engineering controls, process equipment and appropriate personal protective
equipment, in accordance with cGMPs, any Legal Requirements and Regulatory Acts.
DENDREON shall have no responsibility for educating, training, or ensuring
knowledge of any of
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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GSK’s employees regarding (i) the potential hazards associated with the handling
of any Hazardous Materials, Materials, Waste or the manufacture of the Product,
and (ii) the proper use of engineering controls, process equipment and
appropriate personal protective equipment.
     (f) Hazardous Materials and Waste. GSK shall manage the collection,
storage, handling, transportation and disposal of all Hazardous Materials and
Waste generated in the course of GSK performing Services, manufacturing Product
or other activity undertaken under this Agreement; the cost of such activity
being included in the fees or Price paid by DENDREON to GSK. GSK shall collect,
handle, package, label, store, treat or dispose of Hazardous Materials and Waste
in accordance with the Specifications and any Legal Requirements or Regulatory
Acts. All Hazardous Materials and Waste generated by GSK’s performance of
Services, manufacture of the Product or other activity undertaken under this
Agreement shall be handled and/or disposed of by either GSK or by a duly
licensed third party that is reasonably acceptable to DENDREON.
     (g) Permits, Licenses and Authorizations. GSK shall be responsible for
obtaining and shall obtain and maintain all necessary licenses, certificates,
approvals or permits required under Legal Requirements or Regulatory Acts and
any private permissions, whether original documents or modifications to existing
documents, that are necessary to manufacture the Product at the Suite and shall
provide copies thereof to DENDREON upon request by DENDREON. GSK shall provide
DENDREON with immediate verbal notice, confirmed in writing within twenty-four
(24) hours, in the event of revocation or modifications of any license,
certificate, approval or permit, or in regard to any other event or regulatory
action or involvement, such as an order or notice, which in any way impacts upon
GSK’s ability to manufacture and deliver the Product or use of the Suite.
     (h) Compliance with Legal Requirements. GSK represents, warrants and
covenants that, GSK is, and shall continue to be, in full compliance with Legal
Requirements and Regulatory Acts during the Term.
     (i) Government Inspections, Seizures and Recalls. If any Governmental Body
or Regulatory Authority makes an inspection of the Suite relating to the Product
(including any environmental inspection, investigation, notice or inquiry), or
seizes or requests a recall of the Product, GSK shall immediately notify
DENDREON’s Quality Assurance department or such other person or group as
DENDREON may designate in writing of the same and GSK shall take such actions as
may be required under the Quality Agreement in such circumstances. GSK shall
promptly send DENDREON retained samples of Products seized by such Governmental
Body or Regulatory Authority (unless otherwise legally prohibited from doing so)
and make reports relating to such events available to DENDREON.
     (j) Notice of Material Events. Subject to any limitations imposed by Legal
Requirements or Regulatory Acts, GSK agrees to promptly notify DENDREON of any
actual or anticipated events that have, or may be reasonably expected to have, a
material adverse effect on the Products or on GSK’s ability to manufacture and
deliver Products in accordance with the terms of this Agreement, including but
not limited to any labor difficulties, strikes, shortages in Materials, plant
closings, regulatory notices or orders, and other interruptions in plant
operations affecting manufacture or release of the Product.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     (k) Limitation of Warranties. THE REPRESENTATIONS AND WARRANTIES PROVIDED
IN THIS AGREEMENT DO NOT APPLY TO PRODUCT TO THE EXTENT THAT, AFTER SHIPMENT BY
GSK, OCCURRENCES AFFECTING OR ALTERING THE PRODUCT AFTER IT IS DELIVERED TO
DENDREON, OR ACTIONS TAKEN OR FAILED TO BE TAKEN AFTER THE PRODUCT WAS DELIVERED
TO DENDREON, THE PRODUCT FAILS TO CONFORM TO SPECIFICATIONS. EXCEPT AS EXPRESSLY
SET FORTH IN THIS SECTION 9.1, GSK DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OF THE
INTELLECTUAL PROPERTY OF ANY THIRD PARTY.
     9.2 Representations and Warranties of DENDREON. Throughout the Term,
DENDREON represents and warrants to GSK that:
     (a) Status; Enforceability. DENDREON is a validly existing corporation and
is in good standing under the laws of the jurisdiction of its incorporation; the
execution, delivery and performance of this Agreement by DENDREON has been duly
authorized by all requisite corporate governance; this Agreement constitutes a
legal, valid and binding obligation of DENDREON, enforceable against DENDREON in
accordance with the terms hereof, subject to the effect of bankruptcy,
insolvency, reorganization, receivership, moratorium and other similar laws
affecting the rights and remedies of creditors generally and the effect of
general principles of equity, whether applied by a court of law or equity; and
the execution, delivery and performance of this Agreement by DENDREON will not
violate or conflict with any other agreement or instrument to which DENDREON is
a Party.
     (b) Intellectual Property. To DENDREON’s knowledge, the DENDREON
Intellectual Property licensed to GSK pursuant to Article VII is free and clear
of any lien, encumbrance, security interest or restriction on license
inconsistent with the rights granted to GSK herein.
     (c) Licensed Property. To DENDREON’s knowledge, the manufacture and supply
of Product pursuant to this Agreement does not and shall not require a license
under any Intellectual Property owned or controlled by DENDREON or any Third
Party other than as provided to GSK hereunder.
     (d) Noninfringement. To DENDREON’s knowledge, the manufacture and supply of
Product pursuant to this Agreement in accordance with the Specifications does
not infringe the Intellectual Property of any Third Party.
     (e) Sufficient Rights. To DENDREON’s knowledge, DENDREON Intellectual
Property comprises all Intellectual Property necessary for GSK to manufacture
and supply Product in accordance with the Specifications in effect as of the
Effective Date.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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Article X
Liability and Indemnification
     10.1 Indemnity by GSK. Subject to Section 10.4 below, GSK shall indemnify,
defend and hold DENDREON and each DENDREON Affiliate and their respective
directors, officers, employees and agents (each a “DENDREON Indemnitee”)
harmless from and against all Losses arising from any Third Party claim, demand,
suit, action or proceeding (a “Third Party Claim”) and not otherwise reimbursed
by GSK to DENDREON to the extent arising from, based upon or caused by (a) any
breach or nonperformance of GSK’s covenants, obligations, representations or
warranties under this Agreement; (b) GSK’s failure to obtain, maintain or comply
in any material respect with any of its Consents which are required to perform
its obligations hereunder or under the Regulatory Acts or other Legal
Requirements; (c) any material violation of Legal Requirements by GSK in the
performance of its obligations hereunder; or (d) any claim that the practice by
DENDREON of the GSK Intellectual Property licensed hereunder constitutes trade
secret misappropriation or infringes the intellectual property rights of any
Third Party. The foregoing indemnification obligations shall not apply in each
case to the extent any particular Loss is a direct result of (i) the negligence
or intentional misconduct of a DENDREON Indemnitee; (ii) a breach by DENDREON of
a representation, warranty, covenant or obligations hereunder; (iii) any matter
for which DENDREON is obligated to indemnify GSK pursuant to Section 10.2
herein; (iv) any failure by DENDREON to comply with the applicable Regulatory
Acts; or (v) GSK’s compliance with the Specifications or an order of a
Governmental Body directed to GSK specifically regarding its compliance with
cGMPs, the applicable Regulatory Acts, or Legal Requirements. Nothing in this
Section 10.1 or Section 10.2 below shall be construed to limit, and these
provisions shall be in addition to, any indemnification provision, in any other
agreement between the Parties.
     10.2 Indemnity by DENDREON. Subject to Section 10.4 below, DENDREON shall
indemnify, defend and hold GSK and each GSK Affiliate and their respective
directors, officers, employees and agents (each a “GSK Indemnitee”) harmless
from and against all Losses arising from any Third Party Claim and not otherwise
reimbursed by DENDREON to GSK to the extent arising from, based upon or caused
by (a) the distribution or marketing of sipuleucel-T by DENDREON, (b) DENDREON’s
failure to obtain, maintain or comply in any material respect with any of its
Consents which are required to perform its obligations hereunder, or export
permits or under the Regulatory Acts or other Legal Requirements, (c) breach of
DENDREON’s covenants, obligations, representations or warranties under this
Agreement, or (d) any claim that the practice by GSK of the DENDREON
Intellectual Property licensed hereunder infringes the intellectual property
rights of any Third Party. The foregoing indemnification obligations shall not
apply in each case to the extent any particular Loss is a direct result of
(i) the negligence or intentional misconduct of a GSK Indemnitee, (ii) a breach
by GSK of a representation, warranty, covenant or obligation hereunder or
(iii) any matter for which GSK is obligated to indemnify DENDREON pursuant to
Section 10.1 above, or (iv) any failure by GSK to comply with the applicable
Regulatory Acts. Nothing in this Section 10.2 or Section 10.1 above shall be
construed to limit, and these provisions shall be in addition to, any
indemnification provision in and any other agreement between the Parties.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     10.3 Procedures. Any indemnification of GSK, GSK Affiliates, DENDREON or
DENDREON Affiliates hereunder shall include and extend to the benefit of their
respective shareholders, directors, officers and employees. Any person that may
be entitled to indemnification under this Agreement (an “Indemnified Party”)
shall give written notice to the Person obligated to indemnify it (an
“Indemnifying Party”) with reasonable promptness upon becoming aware of any
Third Party Claim or other facts upon which a claim for indemnification may be
based; the notice shall set forth such information with respect thereto as is
then reasonably available to the Indemnified Party, provided however, the
failure to provide such written notice within a reasonably prompt period of time
shall not relieve the Indemnifying Party of any of its obligations hereunder
except to the extent the Indemnifying Party is prejudiced by such failure. The
Indemnifying Party shall have the right to undertake the defense of any such
Third Party Claim with counsel reasonably satisfactory to the Indemnified Party,
provided that the Indemnifying Party shall promptly notify the Indemnified Party
of all material developments in the matter. The Indemnified Party shall
cooperate in such defense and make available all records, materials and
witnesses reasonably requested by the Indemnifying Party in connection therewith
at the Indemnifying Party’s expense. If the Indemnifying Party shall have
assumed the defense of the Third-Party Claim with counsel reasonably
satisfactory to the Indemnified Party, the Indemnifying Party shall not be
liable to the Indemnified Party for any legal or other expenses (other than for
reasonable costs of investigation) subsequently incurred by the Indemnified
Party in connection with the defense thereof. The Indemnified Party shall have
the right, but not the obligation, to be represented by counsel of its own
selection and at its own expense. The Indemnifying Party shall not be liable for
any Third-Party Claim settled without its consent, which consent shall not be
unreasonably withheld or delayed. The Indemnifying Party shall obtain the
written consent of the Indemnified Party prior to ceasing to defend, settling or
otherwise disposing of any Third-Party Claim if as a result thereof the
Indemnified Party would become subject to injunctive or other equitable relief
or if the Indemnified Party may reasonably object to such disposition of such
Third-Party Claim based on a continuing adverse effect on the Indemnified Party.
     10.4 Limitations of Liability. EXCEPT WITH RESPECT TO THIRD PARTY CLAIMS
COVERED BY SECTIONS 10.1 AND 10.2 ABOVE, IN NO EVENT SHALL EITHER PARTY BE
LIABLE TO THE OTHER, FOR ANY CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES OR
LOSSES INCLUDING ANY LOSS OF PROFITS SUFFERED BY DENDREON OR GSK, HOWEVER CAUSED
AND ON ANY THEORY OF LIABILITY, REGARDLESS OF ANY FAILURE OF ESSENTIAL PURPOSE
OF ANY REMEDY AVAILABLE UNDER THIS AGREEMENT.
Article XI
Insurance
     11.1 GSK Insurance Requirements. GSK shall at all times maintain insurance
policies or self-insurance in such amounts and with such scope of coverage as
are adequate to cover GSK’s obligations under this Agreement.
     11.2 DENDREON Insurance Requirements. DENDREON shall at all times maintain
insurance policies or self-insurance in such amounts and with such scope of
coverage as are adequate to cover DENDREON’s obligations under this Agreement.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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Article XII
Confidentiality
     12.1 GSK Confidential Information. As used herein, the term “GSK
Confidential Information” shall mean all information relating to the
biopharmaceutical manufacturing technologies employed by GSK and financial
information provided by GSK, confidential business and technical communications,
documents and other information, in each case, in any form (whether in written,
oral, photographic, electronic, magnetic, computer or other form), including
without limitation methods, techniques and processes, and technical and
scientific data, unpublished findings, biological material, know how,
specifications, patent applications, algorithms, programs, designs, drawings,
formulae, engineering, manufacturing, marketing, financial and business plans
and data, which GSK or a GSK Affiliate furnishes or discloses to DENDREON or
which DENDREON otherwise learns in connection with the negotiation or
performance of this Agreement (whether relating to GSK, a GSK Affiliate or any
Third Party for which GSK has an obligation of confidentiality).
     12.2 DENDREON Confidential Information. As used herein, the term “DENDREON
Confidential Information” shall mean all information owned or possessed by
DENDREON that relates to sipuleucel-T, the Product, or the biopharmaceutical
manufacturing technologies employed by DENDREON related thereto, in each case,
in any form (whether in written, oral, electronic or other form), including
without limitation methods, techniques and processes, and technical and
scientific data, unpublished findings, biological material, know how,
specifications, patent applications, algorithms, programs, designs, drawings,
and formulae, and engineering, manufacturing, marketing, financial and business
plans and data, which DENDREON or a DENDREON Affiliate furnishes or discloses to
GSK or which GSK otherwise learns in connection with the negotiation or
performance of this Agreement (whether relating to DENDREON, a DENDREON
Affiliate or any Third Party for which for which DENDREON has an obligation of
confidentiality).
     12.3 Treatment of Confidential Information. Both during the Term and for a
period of five (5) years thereafter, (or such other period as may be mutually
agreed in the Quality Agreement for any Confidential Information described
therein), DENDREON shall treat all GSK Confidential Information and GSK shall
treat all DENDREON Confidential Information in accordance with the requirements
of this Article XII. For convenience, GSK Confidential Information and DENDREON
Confidential Information are both referred to herein as “Confidential
Information” for purposes of establishing the obligations of each Party with
regard to the other Party’s Confidential Information.
     (a) Nondisclosure. Confidential Information of the disclosing Party shall
be kept strictly confidential by the receiving Party and, except as expressly
permitted herein, shall not be disclosed to any Third Party by the receiving
Party in any manner whatsoever in whole or in part, without first obtaining the
other Party’s prior written consent to such disclosure. The standard of care
required of each Party in protecting the confidentiality of the other Party’s
Confidential Information shall be at least the same standard of care that the
receiving Party uses in protecting its own confidential and trade secret
information, but in no event shall either Party use less than a
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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reasonable standard of care. Confidential Information may be used by the
receiving Party only for the purpose of performing under this Agreement.
     (b) Permitted Exceptions. Each Party may disclose the other Party’s
Confidential Information (i) to its or its Affiliates, employees or outside
advisors, and outside consultants, in connection with this Agreement who
reasonably need to know such information for the purpose of advising or
assisting it in connection with this Agreement and, in the case of DENDREON,
outside consultants, subcontractors and potential collaborators for the
development or commercialization of the Product (each, a “Representative”), and
(ii) to any Parties required under operation of law. Prior to disclosing any
Confidential Information to any Representative pursuant to this Section 12.3(b),
the receiving Party will inform such Representative of the proprietary nature of
the Confidential Information and will require such Representative to agree in
writing (except in the case of outside legal advisors or auditors, who may
orally agree) to be bound by the requirements of this Article XII and not to use
or disclose the Confidential Information except as permitted herein. Each Party
agrees to be responsible for any breach of these confidentiality obligations by
its Representatives.
     12.4 Excluded Information. Notwithstanding any provision herein to the
contrary, the requirements of this Article XII shall not apply to any
information of either Party which:
     (a) at the time of disclosure hereunder is generally available to the
public;
     (b) after disclosure hereunder becomes generally available to the public,
except through breach of this Article XII by the receiving Party or its
Representatives;
     (c) was not acquired directly or indirectly from the disclosing Party or
its Affiliates and which the receiving Party can establish was lawfully in its
possession prior to disclosure by the disclosing Party;
     (d) is independently developed by employees or agents of the receiving
Party or its Affiliates without the use of or reference to the Confidential
Information of the disclosing Party as established by appropriate documentation;
or
     (e) becomes available to the receiving Party from a Third Party that is not
legally prohibited from disclosing such Confidential Information, provided such
information was not acquired directly or indirectly from the disclosing Party or
its Affiliates.
     12.5 Notification of Mandatory Disclosure.
     (a) Procedures. In the event that either Party is required by applicable
law or regulation or by judicial or administrative process to disclose any part
of the other Party’s Confidential Information, such Party shall promptly notify
the other Party of each such requirement and identify the documents so required
thereby, so that the other Party may seek an appropriate protective order or
other remedy and/or waive compliance by the first Party with the provisions of
this Article XII.
     (b) Limitations. If, in the absence of such a protective order or such a
waiver by the other Party of the provisions of this Article XII, the first Party
is nonetheless required by
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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mandatory applicable law to disclose any part of the other Party’s Confidential
Information, the first Party may disclose such of the other Party’s Confidential
Information without liability under this Agreement, except that the first Party
shall furnish only that portion of the other Party’s Confidential Information
which is legally required.
     12.6 Publicity. Neither Party shall issue any press release or otherwise
make any public statement or advertisement (an “Announcement”) with respect to
this Agreement without the prior written consent of the other Party. If, in the
opinion of counsel, a Party is required by Legal Requirements to make an
Announcement, such Party will give the other Party at least fifteen (15) days
prior written notice of the text of the Announcement so that the other Party
will have an opportunity to comment on the Announcement, provided that if Legal
Requirements require that an Announcement be disseminated in less than fifteen
(15) days then the time for giving the other Party prior written notice shall be
reduced by the minimum amount of time required to comply with such Legal
Requirements.
     12.7 Return of Confidential Information. All Confidential Information shall
remain the property of the disclosing Party. At any time upon the request of the
other Party, to the extent such Confidential Information is not reasonably
necessary to enable a Party to perform its obligations under this Agreement, the
receiving Party shall promptly return to the other Party or certify in writing
the destruction of the other Party’s Confidential Information, and shall destroy
all copies thereof, together with all notes, drawings, abstracts and other
information relating to the other Party’s Confidential Information prepared by
the receiving Party or any of its Representatives, regardless of the medium in
which such information is stored; provided however, that the receiving Party may
maintain a single archival copy of the other Party’s Confidential Information in
the Legal Department’s files for purposes of establishing the extent of
disclosures by the other Party under this Agreement. The return and/or
destruction of such Confidential Information as provided above shall not relieve
the receiving Party of its other obligations under this Article XII.
     12.8 Inadequate Remedy. Each Party acknowledges and expressly agrees that
the remedy at law for any breach by it of the terms of this Article XII may be
inadequate and that the full amount of damages which would result from such
breach are not readily susceptible to being measured in monetary terms.
Accordingly, in the event of a breach or threatened breach by either Party of
this Article XII, the other Party shall be entitled to immediately pursue
injunctive relief prohibiting any such breach and requiring the immediate return
of all Confidential Information. The remedies set forth in this Section shall be
in addition to any other remedies available for any such breach or threatened
breach, including the recovery of damages from the breaching Party.
Article XIII
Force Majeure Event
     13.1 General. Neither Party shall be liable to the other on account of any
failure to perform or on account of any delay in performance of any obligation
under this Agreement, if and to the extent that such failure or delay shall be
due to any acts of God, acts of a public enemy, insurrections, civil disorders,
riots, embargoes, , or boycotts, fires, explosions, floods, shortages of
material, utilities or energy or other unforeseeable causes beyond the
reasonable control and without the fault or negligence of the Party so affected
and which, by the exercise of its
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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Commercially Reasonable efforts of diligence and care, such Party could not
reasonably have been expected to avoid (a “Force Majeure Event”). The Party
experiencing the Force Majeure Event and seeking relief under this Article XIII
shall promptly notify the other Party of the Force Majeure Event and use
Commercially Reasonable Efforts to overcome such Force Majeure Event. The Party
affected shall promptly notify in writing the non-affected Party of the specific
causes beyond the control of the affected Party and the probable duration of the
Force Majeure Event, and that Party shall be excused from the performance of
such obligation to the extent such performance is necessarily prevented,
hindered or delayed thereby during the continuance of any such Force Majeure
Event. This Agreement, in so far as it relates to such obligation, shall be
deemed suspended so long as and to the extent that such cause delays the
performance of any Force Majeure Event obligation.
     13.2 Force Majeure Recovery Assessment/Plans. Within sixty (60) days of the
Force Majeure Event, or as otherwise agreed between the Parties, the JMC will
determine if the Force Majeure Event is recoverable or non-recoverable. A
“non-recoverable” Force Majeure Event, for purposes of this Section 13.2, shall
mean a Force Majeure Event from which the Parties cannot resume their
obligations under this Agreement within six (6) months of the commencement of
the Force Majeure Event, or such longer period of time as the Parties may
mutually agree. If the JMC determines the Force Majeure Event is
non-recoverable, the Parties shall negotiate in good faith the termination of
the Agreement. If the JMC determines the Force Majeure Event is recoverable, a
recovery plan shall be jointly developed, including an equitable risk-based
sharing of costs incurred by GSK during the Force Majeure Event and associated
with implementation of the recovery plan.
Article XIV
Term; Termination; Remedies
     14.1 Term. Unless earlier terminated pursuant to the terms of this
Agreement, the term of this Agreement shall extend through December 31, 2015
(the “Term”). DENDREON may request one or more two-year extensions of the
Agreement by providing GSK with written notice no less than eighteen (18) months
prior to the then applicable expiration date. Any extension of the Term shall
not be effective unless memorialized by an amendment to this Agreement executed
by the Parties pursuant to Section 16.6.
     14.2 Termination.
     (a) Material Breach. Either Party may terminate this Agreement upon sixty
(60) days’ prior written notice to the other Party, if a Party commits a
material breach of this Agreement and, following notice by the non-breaching
Party, fails to cure such material breach within the sixty (60) day notification
period. In the event that a material breach is due solely to DENDREON’s failure
to tender payment within sixty (60) days after such payment is due and upon
being so notified by GSK in writing, DENDREON fails to fully cure within thirty
(30) days after notification, GSK may, in its sole discretion, (i) elect to
suspend any further performance under this Agreement until all outstanding
payments are received or (ii) terminate this Agreement at the end of such ninety
(90) day period.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     (b) Bankruptcy. Either Party may immediately terminate this Agreement upon
written notice to the other Party, if a Party becomes insolvent or acknowledges
its inability to pay its debts as they become due, files a petition for
bankruptcy, makes an assignment for the benefit of its creditors or has a
receiver, trustee or other court officer appointed for its properties or assets.
     (c) Product Withdrawal. DENDREON shall be entitled to terminate this
Agreement upon written notice to GSK in the event sipuleucel-T is permanently
withdrawn from the United States market.
     (d) Failure to Implement Process. In the event that there is a failure to
implement the Process as more fully described in Section 2.4, either Party may
terminate this Agreement as provided in Section 2.4.
     (e) Short Quantity Year. If anytime after January 1, 2011, DENDREON revises
the Forecast pursuant to Section 3.3 and such revision results in Firm Orders
for the aggregate quantity of Product to be less than [***] during any calendar
year (a “Short Quantity Year”), then GSK shall have the right to terminate the
Agreement by providing DENDREON with written notice. Unless otherwise agreed to
by the Parties, the effective date of such termination shall be eighteen
(18) months after the date of such termination notice.
     14.3 Effect of Expiration or Termination.
     (a) In the event of a termination of this Agreement, the following shall
occur:
          (1) Return of DENDREON Equipment. GSK shall return to DENDREON at
DENDREON’s expense all DENDREON Equipment that has been procured on behalf of
DENDREON for which DENDREON has issued payment, as set forth on Schedule 2.2A,
as may be amended from time to time by the Parties. Title to any non-portable
DENDREON Equipment located in the Suite, as set forth on Schedule 2.2A, shall
pass to GSK upon the termination of this Agreement at no cost to GSK, whichever
is later. For any equipment that is being returned to DENDREON hereunder, GSK
shall arrange for the prompt return of any such equipment at DENDREON’s expense
with carriers or subcontractors approved by DENDREON.
          (2) Return of Materials. GSK shall ship unused identified and tracked
Materials related to the Process to a location designated by DENDREON at
DENDREON’s expense, or instruct GSK to destroy such Materials at DENDREON’s
expense. DENDREON shall pay for all Materials that are in process, purchased and
in inventory and any commitments made by GSK in the performance of this
Agreement that cannot be cancelled without charge.
          (3) GSK shall cooperate with DENDREON as reasonably requested in order
to support the transfer of the Process to a DENDREON facility or that of a third
party, including providing copies of all necessary batch records, documents and
records detailing the performance of the Process by GSK, all of which shall be
deemed owned by DENDREON.
          (4) [***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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          (5) [***]

          (6) [***]
Article XV
Governance
     15.1 Governance. Promptly after the Effective Date, each Party shall
designate a Project Manager to oversee the technology transfer of the Process
and related analytical methods, the Services and the manufacture of the Product.
In addition, a Joint Management Committee (“JMC”) shall be formed promptly after
the Effective Date in order to resolve issues that may arise in connection with
the transfer of the Process, the provision of Services and the manufacture of
the Product, including, but not limited to, quality disputes related to
manufactured Product and pricing issues related to the Product. The JMC shall be
made up of an equal number of representatives from each Party and decisions of
the JMC shall require unanimous vote. If the JMC is still unable to resolve the
dispute, the JMC may refer the dispute, by notice to the respective officers
designated below or such other officers as the Parties may designate in writing
from time to time, for attempted resolution by good faith negotiations within
thirty (30) days after such notice is received. The designated officers are as
follows:

         
 
  For GSK:   Vice President, Site Director of GMS Biopharm
 
       
 
  For DENDREON:   Senior Vice President, Operations

If such dispute is not resolved by the end of the thirty (30) day period, the
Parties may proceed to pursue whatever legal remedies that may be available to a
Party either in law or in equity. In addition to its role in dispute resolution,
the JMC shall also be authorized to consider any significant matters or issues
that are raised for its consideration by either Party, at that Party’s sole
option, regardless of whether the matter or issue has been previously considered
by the JMC. GSK shall be entitled to reimbursement of expenses incurred by GSK
due to any changes adopted by the JMC that impact GSK’s operating costs. Each
Party shall reasonably cooperate with the other Party in connection with the
activities to be performed under this Agreement.
     15.2 Remedies. Except as expressly set forth in this Agreement, none of the
remedies set forth in this Agreement are intended to be exclusive, and each
Party shall have available to it all remedies available under law or in equity.
     15.3 Injunctive Relief. In the event that either DENDREON or GSK breaches
or threatens to breach any provision of Article VII or Article XII of this
Agreement, the Parties agree that irreparable harm to the other Party shall be
presumed and the damage to such Party would be very difficult to ascertain and
monetary damages would be inadequate. Accordingly, in the event of such
circumstances, each of DENDREON and GSK agree that, in addition to any other
right and remedies available at law or in equity, the other Party shall have the
right to obtain injunctive relief from any court of competent jurisdiction.
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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     15.4 Governing Law. This Agreement shall be governed by, construed and
enforced in accordance with the laws of the State of New York without regard to
principles of conflicts of law.
Article XVI
Miscellaneous
     16.1 Standard Forms. In all communications, GSK and DENDREON may employ
their standard forms, but nothing in those forms shall be construed to modify or
amend the terms and conditions of this Agreement, and, in the case of any
conflict herewith, the terms and conditions of this Agreement shall control.
     16.2 Notices. In addition to the other specific procedures for notification
required herein, all notices, demands, requests and other communications made
hereunder shall be in writing and shall be given either by personal delivery, by
nationally recognized overnight courier (with charges prepaid), by electronic
transmission (provided such transmission shall include information from which it
can be determined that it was authorized by a Party hereto and the receipt of
such transmission is confirmed by telephone) or by facsimile transmission (with
telephone confirmation), and shall be deemed to have been given or made: (i) if
personally delivered, on the day of such delivery; (ii) if sent by overnight
courier, on the day following the date deposited with such overnight courier
service; (iii) if by electronic transmission, on the date transmitted on such
electronic medium; or (iv) if by facsimile transmission, on the date transmitted
to receiving facsimile machine and confirmed by telephone, in each case pending
the designation of another address, addressed as follows:
     If to GSK:
GlaxoSmithKline
Building 40
Conshohocken, PA 19406
Attention:           General Manager, Biopharmaceuticals
Facsimile:           (610) 239-3883
     With a copy (which shall not constitute notice) to:
GlaxoSmithKline
Five Moore Drive
Research Triangle Park, NC 27709
Attention:           Vice President, Associate General Counsel
                            Legal Operations — GMS
Facsimile:           (919) 483-2881
     If to DENDREON:
3005 First Avenue
Seattle, Washington 98121
Attn: Senior Vice President, Operations
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

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Facsimile: (206) 219-7211
           With a copy to:
3005 First Avenue
Seattle, Washington 98121
Attn: General Counsel
Facsimile: (206) 219-7211
     16.3 Independent Contractors. In the exercise of its obligations and in
respect of its rights and entitlements hereunder or in respect hereof, DENDREON
and GSK are and shall in all respects be treated as independent contractors with
respect to each other. Neither Party shall be deemed to be a co-venturer or
partner of the other. Neither Party is an employee or a legal representative of
the other Party for any purpose. Neither Party shall have the authority to enter
into any contracts in the name of or on behalf of the other Party.
     16.4 Entire Agreement. This Agreement, the Heads of Agreement, any
Schedules hereto, any executed Scope Changes, and any other document referenced
herein, represents the entire understanding and agreement between the Parties
hereto with respect to the subject matter hereof, and supersedes all prior and
contemporaneous agreements and understandings between the Parties with respect
to such subject matter. In the event of a conflict in the terms of this
Agreement and the terms of the Heads of Agreement, the terms of this Agreement
shall govern.
     16.5 Transferability; Binding Effect. Neither this Agreement, nor any of
the rights or obligations of a Party may be directly or indirectly assigned,
sold, delegated or otherwise disposed of without the prior written consent of
the other Party, and any attempted assignments without such written consent
shall be of no effect; provided however, that either Party may assign its
obligations under the Agreement to any Third Party or entity pursuant to a
Change in Control or sale of all or substantially all of the assets of the Party
to which this Agreement relates.
     16.6 Amendment. Any amendment, modification or supplement of or to any
provision of this Agreement, including the Schedules hereto, shall be effective
only in a written document that is signed by a duly authorized officer of
suitable title of all Parties hereto. The Parties hereto waive the right to
amend the provisions of this Section 16.6 orally.
     16.7 Severability. If and to the extent that any court of competent
jurisdiction holds any provision (or any part thereof) of this Agreement to be
invalid or unenforceable, such holding shall in no way affect the validity or
enforceability of the remainder of this Agreement, and the invalid or
unenforceable provision shall be fully severed from this Agreement and there
shall automatically be added in lieu thereof a provision as similar in terms and
intent to such severed provision as may be legal, valid and enforceable.
     16.8 Waiver. Any failure of DENDREON or GSK to comply with any obligation,
covenant, agreement or condition herein contained may be expressly waived, in
writing only, by
 

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Securities and Exchange Commission pursuant to a request for confidential
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the other Party hereto and such waiver shall be effective only in the specific
instance and for the specific purpose for which made or given.
     16.9 Survival. Sections 2.2, 4.6, 4.7, 5.2, 5.3, 7.1, 7.2, Article X,
Article XI, Article XII, Sections 14.3, 15.2, 15.3, 15.4, 16.9 and 16.10 and any
other provision which by its terms specifically shall so state, together with
any obligation to make accrued but unpaid payments due hereunder, shall survive
the termination or expiration of this Agreement until the last-to-expire of the
longest statute of limitations governing any claims relating to a Party’s
performance under this Agreement.
     16.10 Drafting Ambiguities. Each Party to this Agreement and its counsel
have reviewed and revised this Agreement. The rules of construction to the
effect that any ambiguities are to be resolved against the drafting Party shall
not be employed in the interpretation of this Agreement or any amendment or
Schedule to this Agreement.
     16.11 Headings; Schedules; Counterparts.
     (a) Headings. The headings of the Sections of this Agreement are for
reference purposes only, are not part of this Agreement and shall not in any way
affect the meaning or interpretation of this Agreement.
     (b) Schedules. All Schedules delivered pursuant to this Agreement shall be
deemed part of this Agreement and incorporated herein by reference, as if fully
set forth herein. All provisions contained in any Schedule delivered by or on
behalf of the Parties hereto, or in connection with the transactions
contemplated hereby, are an integral part of this Agreement. In the case of a
conflict between this Agreement and any Schedule, except with respect to the
Quality Agreement, this Agreement shall control.
     (c) Counterparts. This Agreement and any amendment hereto may be executed
in any number of counterparts, each of which when executed and delivered shall
be deemed to be an original and all of which counterparts taken together shall
constitute but one and the same instrument. The exchange of copies of this
Agreement or amendments thereto and of signature pages by facsimile transmission
or by email transmission in portable document format, or similar format, shall
constitute effective execution and delivery of such instrument(s) as to the
Parties and may be used in lieu of the original Agreement or amendment for all
purposes. Signatures of the Parties transmitted by facsimile or by email
transmission in portable document format, or similar format, shall be deemed to
be their original signatures for all purposes.
     (d) Purchase Orders. The terms and conditions of this Agreement shall be
the only terms and conditions that shall govern the ordering of Product and the
terms and conditions of any Purchase Order issued by DENDREON shall be of no
force or effect and purchase orders shall be used for scheduling purposes only.
[signature page follows]
 

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Securities and Exchange Commission pursuant to a request for confidential
treatment.

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[Signature Page to Development and Supply Agreement]
     IN WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to
be duly executed as of the date first written above.

                  GLAXOSMITHKLINE LLC    
 
           
 
  By:
Name:   /s/ William J. Mosher
 
William J. Mosher    
 
  Title:   Vice President and Secretary    
 
                DENDREON CORPORATION    
 
           
 
  By:
Name:   /s/ Richard F. Hamm, Jr.
 
Richard F. Hamm, Jr.    
 
  Title:   Senior Vice President, Corporate Development, General Counsel and
Secretary    

 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 2.1B
SCOPE OF WORK
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 2.1C
PROCESS TRANSFER APPLICABLE QUALITY STANDARDS
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 2.2A
DENDREON EQUIPMENT LIST
[***]
 

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Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 3.1A
QUALITY AGREEMENT
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 4.1
PRICE
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 5.1A
SPECIFICATIONS AND RELEASE TESTING
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 5.1B
MATERIAL AND IN-PROCESS TESTS
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 5.1C
CERTIFICATE OF ANALYSIS
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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SCHEDULE 5.1D
“GSK RELEASE” FLOW FOR PA2024
[***]
 

[***]   Denotes confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.