exv10w1






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.




 









 





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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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







 



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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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     “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




 



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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.




 



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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




 



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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.




 



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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.




 



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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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     (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





 




			
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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






 




			
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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.




11









 









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.





 




			
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12









 










     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.





 




			
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13









 










     (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





 




			
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14









 









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.





 




			
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15












 





     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





 




			
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16









 




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







 




			
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17









 









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





 




			
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18









 









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





 




			
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19









 









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.





 




			
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20









 










     (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.




21









 










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.




22









 










     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.




23









 










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.






24












 




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.




25









 









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.




26









 









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.




27









 










     (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.




28









 










          (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.





29









 





     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.




30









 









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





 




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





31









 




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]






 




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




32









 










[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.






 











 





SCHEDULE 2.1B




SCOPE OF WORK



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










SCHEDULE 2.1C




PROCESS TRANSFER APPLICABLE QUALITY STANDARDS



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










SCHEDULE 2.2A




DENDREON EQUIPMENT LIST



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










SCHEDULE 3.1A




QUALITY AGREEMENT



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










SCHEDULE 4.1




PRICE



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










SCHEDULE 5.1A




SPECIFICATIONS AND RELEASE TESTING



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










SCHEDULE 5.1B




MATERIAL AND IN-PROCESS TESTS



[***]





 




			
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Exchange Commission pursuant to a request for confidential treatment.




 









 










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.




 









 










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.