LEUKAPHERESIS SERVICES
AGREEMENT
This Agreement
(“Agreement”) is made as of September 24, 2009
(“the Effective Date”) between Dendreon Corporation, a
Delaware Corporation, (“Dendreon”), with offices at
3005 First Avenue, Seattle, Washington 98121 and American National
Red Cross (“ARC”), a nonprofit, charitable corporation
chartered by an act of the United States Congress, on behalf of its
participating blood services regions, each a “Collection
Center”), with offices at 2025 E Street NW, Washington, DC
20006.
WHEREAS, ARC
provides leukapheresis collection services for those in need of
such services throughout the United States;
WHEREAS, Dendreon
desires to obtain clinical trial and/or commercial leukapheresis
collections in connection with the development and
commercialization of Dendreon’s immunotherapeutic cancer
product candidates; and
WHEREAS, ARC is
willing to provide such services on behalf of Dendreon though
ARC’s network of Collection Centers throughout the United
States.
NOW, THERFORE, in
consideration of the mutual covenants and undertakings contained
herein, ARC and Dendreon, intending to be legally bound, hereby
agree as follows:
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(a)
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“ Affiliate ”
shall mean, with respect to any person or entity, any other person
or entity, which controls, is controlled by or is under common
control with such person or entity. For purposes of this Agreement,
a person or entity shall be in “control” of an entity
if it owns or controls at least fifty percent (50%) of the equity
securities of the subject entity entitled to vote in the election
of directors (or, in the case of an entity that is not a
corporation, for the election of the corresponding managing
authority), or otherwise has the power to control the management
and policies of such other entity.
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(b)
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“Collection Center
Sites” shall mean the Sites listed on Exhibit B and
amended from time to time as agreed upon by the parties.
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(c)
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“Confidential
Information” means all non-public and/or proprietary
information owned or possessed by the disclosing party and provided
to the receiving party, whether disclosed in writing or orally. It
includes apheresis procedures, financial records, 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, and any information
disclosed by disclosing party to receiving party pursuant to this
Agreement.
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(d)
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“Procedures” shall mean
a series of tasks performed in a definite, regular order in
accordance with instructions that are version controlled and
approved by appropriate personnel.
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(e)
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“Services” shall have
the meaning set forth in Section 2(a).
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(f)
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“Term” has the meaning
set forth in Section 11(a).
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2.
Services, Scheduling and Compliance with Law
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(a)
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Collection Center shall provide
services to Dendreon in the form of clinical trial and/or
commercial leukapheresis collections (for purposes of this
Agreement, the terms leukapheresis (mononuclear cell (MNC)
collection) and apheresis shall be interchangeable) and any other
services that are mutually agreed to in writing in accordance with
the terms and conditions contained in this Agreement
(“Services”), including without limitation those
services set forth in the Exhibits which are attached hereto and
incorporated herein and which set forth procedures for
leukapheresis collections. The Services will be performed on
patients referred to Collection Center by Dendreon.
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(b)
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Collection Center agrees to perform
these Services (i) in strict accordance with the terms of this
Agreement, including all Exhibits hereto, (ii) in compliance
with all applicable federal, state, and local laws, rules,
regulations, ordinances, and guidelines (collectively, the
“Legal Requirements”), including without limitation
applicable FDA regulations, guidances, guidelines, and policies,
(iii) in compliance with any written instructions of Dendreon
and (iv) in a professional manner that meets industry
standards.
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(c)
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Collection Center shall ensure that
adequate personnel are available to perform the Services hereunder.
The level of staffing and staffing patterns shall be at the
discretion of the Collection Center, subject to the foregoing
sentence. All Collection Center personnel performing Services shall
be duly licensed health care professionals, according to the
applicable individual state requirements, who are trained to
perform the leukapheresis collections and otherwise perform the
Services. Collection Center shall also provide the appropriate
supplies, apheresis equipment approved by FDA for mononuclear cell
collections, and pharmaceuticals that are reasonably necessary for
the performance of the Services, except as set forth on Exhibit A
or otherwise expressly agreed by the parties. Collection Center
shall provide pharmaceuticals for use as reasonably necessary for
the performance of the Services (e.g., Heparin, Epinephrine, normal
saline, IV calcium gluconate, Tums, Diphenhydramine, and
Methylprednisolone). All equipment used by Collection Center
relating to the Services shall be maintained in accordance with the
manufacturer’s specifications.
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(d)
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During the term of this Agreement,
Collection Center agrees to meet with designated representatives of
Dendreon to discuss the progress and results of the Services, and
ongoing plans and changes in the Services. Collection Center
participants in such meetings will include staff trained and
knowledgeable about the provision of services for Dendreon, and
other Collection Center staff as appropriate. At a minimum,
Dendreon and Collection Center shall meet on at least a quarterly
basis, and more frequently if required, for a business planning
forecasting discussion, which Collection Center may utilize for its
capacity and resource planning purposes.
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(e)
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Collection Center shall coordinate
all scheduling activities with Dendreon in accordance with the
terms set forth on Exhibit A hereto.
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3.
Collection Center Locations
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(a)
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Collection Center proposes to
provide Services in accordance with this Agreement at the locations
(“Sites”) set forth on Exhibit B, attached hereto.
Exhibit B shall be amended from time to time as agreed upon
between the parties.
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(b)
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Collection Center shall be the
preferred provider of leukapheresis services to Dendreon within the
United States of America, either directly or via subcontractor
relationships it develops. Collection Center shall have the right
to make the first offer to provide Services to Dendreon in a select
geographic region, which Dendreon shall in good faith consider and
engage in discussions with Collection Center over a period of not
less than thirty (30) days, following which Dendreon has the
right to identify and engage another entity to provide Services in
such region if desired.
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(c)
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The
list of Sites set forth on Exhibit B shall be confirmed by
Dendreon and the Services shall be implemented by Collection Center
upon completion of qualification and site inspection of each Site
by Dendreon, training of licensed staff, technicians and other
office personnel. Dendreon shall provide the initial training.
Thereafter, Collection Center shall be responsible for training all
other personnel. Dendreon and Collection Center will work together
to develop a training plan for subsequent sites. The implementation
schedule shall provide for one or more tests prior to commencement
of the Services.
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4.
Chain of Identity, Labeling, Packaging and Shipping of
Leukapheresis Products
Collection Center
Sites shall maintain chain of identity with Dendreon regarding
Patients and/or cell collections in accordance with the
requirements set forth on Exhibit C, hereto.
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(a)
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Collection Center agrees to maintain
a privacy policy to protect the information of
individuals.
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(b)
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Collection Center agrees to ensure
that all personnel performing the Services under this Agreement
review and are aware of the Collection Center’s privacy
policy.
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(c)
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Collection Center agrees not to
disclose confidential patient data to any third party or to use
such data for any purpose other than providing the Services
outlined in this Agreement, provided, however, that Collection
Center may disclose patient information pursuant to law or court
order, provided, however, that Collection Center shall inform
Dendreon within 24 hours of any such mandated
disclosure.
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(d)
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In
the event that Collection Center receives a request to produce or
provide confidential patient information to a government agency or
other third party, Collection Center agrees to notify Dendreon of
such request, to the extent permitted by the government agency or
third party.
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(e)
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Collection Center agrees to allow
Dendreon and/or its designated representatives from time to time
and upon reasonable advance notice to review Collection
Center’s privacy policy. All such designated representatives
shall be employees of Dendreon.
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(f)
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Collection Center employees will
only access and use confidential Dendreon patient data as needed to
perform the Services and Collection Center functions.
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(g)
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Collection Center will use prudent
and reasonable precautions to maintain and store confidential
Dendreon patient data in a secure manner in an effort to prevent
unauthorized access to systems and locations where personal donor
information is stored.
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(h)
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Collection Center will limit access
to confidential Dendreon patient data to authorized
individuals.
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(i)
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Collection Center shall immediately
report to Dendreon in writing of any use and/or disclosure of
confidential patient information that is not permitted or required
under this Agreement which Collection Center becomes aware within
five (5) business days of Collection Center’s discovery
of such unauthorized use or disclosure. Collection Center will take
reasonable steps to mitigate or rectify any harm that may result
from such unauthorized use or disclosure, and take reasonable
actions to prevent any similar unauthorized use or disclosure in
the future.
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6.
Communications Protocol
Collection Center
Sites shall communicate with Dendreon regarding Patients and/or
cell collections in accordance with the requirements set forth on
Exhibit D, hereto.
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7.
Regulatory and Quality Requirements
Collection Center
shall conduct all Services in accordance with and shall strictly
adhere to the requirements of the Regulatory and Quality
requirements set forth in Exhibit E.
8.
Regulatory and Quality Control
Collection Center
shall conduct all Services in accordance with and shall strictly
adhere to the Regulatory and Quality Control standards set forth in
Exhibit F.
9.
Adverse Events Reporting
Collection Center
shall strictly adhere to any and all Legal Requirements for
reporting adverse events in accordance with the same. All adverse
events occurring during any clinical cell collection procedure
conducted on behalf of Dendreon should be reported per the clinical
trial protocol. Adverse events occurring during any commercial cell
collection procedure may be reported to Dendreon’s Call
Center. The Collection Center shall provide responses to a series
of questions about the adverse event as described in
Exhibit G, Adverse Events Reporting Requirements. In addition,
the Collection Center shall follow its own Procedures for reporting
adverse events to FDA and adhere to Collection Center’s
policies and standards of care for medical management of
patients.
10.
Complaint Investigation
Dendreon and
Collection Center shall work together in good faith to develop a
process to capture, address, track and report on Complaints
utilizing the Collection Center’s Problem Management
System.
Within the
Collection Center’s Problem Management System, a Complaint is
currently defined as any written, electronic, or oral communication
that alleges deficiencies related to the identity, durability,
reliability, safety, effectiveness, or performance of any device,
blood component, blood product, process, procedure, or employee
performance that impacts donor or product safety.
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(a)
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This Agreement shall commence on the
Effective Date and remain in effect for five (5) years, unless
terminated earlier in accordance with the provisions of this
Section 10 (the “Initial Term”). Thereafter, this
Agreement will renew automatically for additional 1 (one) year
periods (“Subsequent Term” and together with the
Initial Term, the “Term”) unless otherwise terminated
in accordance with the provisions of this section. The successful
completion of site inspections and qualification of additional
Sites shall not “restart” the clock for purposes of
establishing the Effective Date of this Agreement, but rather such
additional Sites shall simply be added to the list of Sites which
have been approved by Dendreon to provide Services under this
Agreement.
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(b)
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Either party may terminate this
Agreement without cause by giving twelve (12) months prior
written notice to the other party. In addition,
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either party may terminate this
Agreement for cause upon thirty (30) days prior notice to the
other party, defined as any material breach of this Agreement,
which shall remain uncured following fifteen (15) days notice.
Any termination shall be without prejudice to any claims that
either party may have against the other. Dendreon’s sole
responsibility in the event of termination shall be to reimburse
Collection Center for Services actually and satisfactorily
performed by Collection Center up to the effective date of
termination. Upon expiration or termination of this Agreement,
Collection Center shall promptly return to Dendreon any and all
copies of Confidential Information (as defined above) in Collection
Center’s possession, as well as any other equipment or
supplies provided by Dendreon to Collection Center
hereunder.
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(c)
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In
the event that either party elects to terminate this Agreement
pursuant to the terms set forth above, the parties agree to work
together cooperatively and in good faith to wind up their business
relationship, transfer cell collection responsibilities to those
providers as may be designated by Dendreon, comply with regulatory
requirements applicable to the termination, and otherwise complete
an orderly termination.
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(d)
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Sections 5, 15, 16, 19, 20, 23,
24, 25 and 29 shall survive any expiration or termination of this
Agreement for the time period set forth therein, or if no time
period is set forth therein, then indefinitely.
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12.
Payment for Services Rendered
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(a)
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Compensation for the Services will
be as shown in Exhibit H.
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(b)
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Following the first year of
commercialization, and for the remaining four years of the term of
this Agreement, the parties agree that the prices as shown in
Exhibit H shall be adjusted on an annual basis, in accordance
with changes in the national (US City Average), Medical Care
Consumer Price Index measuring urban consumers for the previous
twelve (12) month period as published by the Bureau of Labor and
Statistics. At least sixty (60) days prior to the fifth
anniversary of this Agreement, the parties will review the terms
set forth in this Section 12 to mutually assess and revise the
pricing terms set forth herein. In the event that the parties agree
to revise such pricing terms, Dendreon shall draft an amendment to
this Agreement, to be signed by both parties, which shall set forth
the revised pricing terms. In the event that the parties are unable
to reach an agreement regarding a revision to the pricing terms,
either party may terminate this Agreement in accordance with
Section 11 above.
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(c)
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Collection Center will send Dendreon
a monthly invoice that itemizes the previous month’s Services
on a per procedure basis with the associated purchase order number
and chain of identity number referenced to each leukapheresis
procedure. Dendreon will pay each
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such invoice within thirty
(30) days of receipt, except that Dendreon may withhold
payment on any invoiced amounts that it disputes. In the event that
Dendreon disputes any invoiced amount, it shall so notify
Collection Center in writing, and the parties shall negotiate in
good faith to resolve the matter as expeditiously as
possible.
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(d)
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If
applicable, Collection Center shall pay all federal, state, and
local taxes that arise out of the Services hereunder.
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(e)
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If,
for any reason attributable:
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1.
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solely to Collection Center, a
leukapheresis procedure is cancelled after it begins or Collection
Center cannot accommodate a patient for whom a leukapheresis
procedure was previously scheduled with Dendreon’s Call
Center, Collection Center shall receive no payment. Collection
Center shall report any failure to commence or complete a
leukapheresis procedure to Dendreon within one (1) hour of
such failure.
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2.
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in
part to Collection Center, a leukapheresis procedure is cancelled
after it begins or Collection Center cannot accommodate a patient
for whom a leukapheresis procedure was previously scheduled with
Dendreon’s Call Center, Dendreon and Collection Center will
work together in good faith through an agreed-upon resolution
process to determine the appropriate payment to Collection Center.
Collection Center shall report any failure to commence or complete
a leukapheresis procedure to Dendreon within one (1) hour of
such failure, and Dendreon and Collection Center shall agree upon
the appropriate payment within thirty (30) days of such
failure.
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3.
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in
no part to Collection Center, a leukpaheresis procedure is canceled
after it begins or if a procedure is cancelled with less than the
agreed upon advance notice given per Exhibit H, Collection
Center shall receive the cancelation fee payment per
Exhibit H.
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(f)
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If
Dendreon makes a payment to Collection Center and the parties
mutually agree that the Collection Center was not entitled to such
payment (or a portion thereof), Dendreon shall be entitled to
deduct the amount of such payment from any amount due to Collection
Center in the invoice immediately following the discovery of such
overpayment:
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13.
Representations and Warranties
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(a)
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Collection Center covenants,
represents and warrants as follows:
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(i) Collection
Center has all necessary rights, powers, licenses, certifications,
and authorities to enter into this Agreement.
(ii) Collection
Center’s performance under this Agreement does not conflict
with or create a breach or a default of any law, order or a court
or government agency, contract or other obligation with any third
party.
(iii) Collection
Center shall at all times conform to FDA requirements and any other
applicable state or federal requirements in performing under this
Agreement.
(iv) To prevent
the introduction, transmission, or spread of communicable diseases
by leukapheresis collections performed under this Agreement,
Collection Center shall, at a minimum, use aseptic techniques for
performing the leukapheresis collections.
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(b)
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Dendreon covenants, represents and
warrants as follows:
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(v) Dendreon is a
corporation organized under the laws of the state of Delaware and
has all necessary rights, powers and authorities to enter into this
Agreement.
(vi)
Dendreon’s performance under this Agreement does not conflict
with or create a breach or a default of any law, order of a court
or government agency, contract or other obligation with any third
party.
14.
Independent Contractor
The parties are
independent contractors and will not act as an employee, agent,
partner, joint venturer or co-venturer of the other. Neither party
will enter into any agreement(s) or incur any obligations on behalf
of the other, or commit the other party in any manner without such
other party’s prior written consent.
Each party agrees
not to use the name, emblem, logo or marks of the other party to
this Agreement in any advertising, news release, or other
publication or public statement, without the prior written consent
of the other party.
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(a)
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Indemnification by Collection
Center: Collection Center agrees to defend, hold harmless and
indemnify Dendreon, its directors, officers, employees and agents
and its and its respective successors, heirs and assigns (the
“Dendreon Indemnitees”) against any legal liability,
claims, demands, actions, judgments, liability, loss, damage and
expenses (including reasonable attorneys’ fees)
(collectively, the “Liabilities”) with respect to
bodily injury, death and property damage actually incurred by the
Dendreon Indemnitees as a result any third
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party claims, demands or judgments,
to the extent such liability arises out of (a) Collection
Center Indemnitees’ alleged negligence in the conduct of the
Services by Collection Center under this Agreement, including any
failure to maintain the Chain of Identity of the leukapheresis
collection product, and (b) any alleged unauthorized use,
disclosure, infringement or misappropriation of any patent,
trademark, copyright, or other intellectual property, right or
trade secret of a third party by Collection Center; and
(c) performance by the Collection Center Indemnitees of any
obligations of Collection Center under this Agreement. However, in
no instance shall Collection Center be responsible to the Dendreon
Indemnitees for any Liabilities to the extent caused by any
wrongful or negligent act or omission of the Dendreon Indemnitees
individually or collectively.
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(b)
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Indemnification by Dendreon:
Dendreon agrees to defend, hold harmless, and indemnify Collection
Center, its governors, directors, officers, medical and
professional staff, employees and agents and its successors, heirs
and assigns (the “Collection Center Indemnitees”)
against Liabilities with respect to bodily injury, death, and
property damage actually incurred by Collection Center Indemnitees,
or which may be asserted or claimed against the Collection Center
Indemnitees, as a result of any third party claims, demands or
judgments, to the extent such Liabilities arise out of (a) the
alleged negligence of Dendreon, its directors, officers, employees,
contractors, licensees, Affiliates or agents in connection with the
design, production, manufacture, sale or use in commerce, or
promotion of sipuleucel-T, (b) any use of sipuleucel-T by any
person, (c) performance by the Dendreon Indemnitees of any
obligations of Dendreon under this Agreement, and, (d) any
alleged unauthorized use, disclosure, infringement or
misappropriation of any patent, trademark, copyright, or other
intellectual property, right or trade secret of a third party by
Dendreon. However, in no instance shall Dendreon be responsible to
the Collection Center Indemnitees for any Liabilities to the extent
caused by any wrongful or negligent act or omission of the
Collection Center Indemnitees individually or
collectively.
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(c)
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Requirements for Indemnification: A
party seeking indemnification under this Section 15 shall
provide prompt written notice of circumstances that might
reasonably be expected to give rise to a claim for indemnification
and of the initiation of any action or proceeding that may
reasonably lead to a claim for indemnification. Upon such notice
and acknowledgement of the indemnifying party’s obligation to
indemnify, the indemnifying party shall have the right to assume
the defense and settlement of any such action or proceeding,
provided that the indemnifying party shall not settle any action or
proceeding with any admission of liability or wrongdoing by the
indemnified party without such indemnified party’s prior
written consent. No action or proceeding shall be settled without
the prior written consent of the
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indemnifying party, which consent
shall not be unreasonably withheld, and the indemnifying party
shall not be responsible for any legal fees or other costs incurred
other than as provided herein. The indemnified party shall
cooperate fully with the indemnifying party and its legal
representatives in the investigation and defense of any action or
proceeding covered by this indemnification. 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 in or with
respect to any such action or other proceeding.
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(a)
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Mutual Insurance Requirements.
Collection Center and Dendreon shall each maintain:
(i) Commercial General Liability insurance, including
contractual liability coverage, in an amount not less than
$5,000,000 per occurrence and $5,000,000 annual aggregate for their
respective work under this Agreement and naming the other
Party’s indemnitees as additional insured as their interests
may appear, and (ii) Property insurance providing coverage for
their respective equipment supplies and premises during the Term of
this Agreement. Any commercial insurance policies obtained by each
party shall be with insurance carriers having an AM Best Rating of
“A X” or higher. Insurance coverage limits may be met
by a combination of primary and excess or umbrella policies. Each
party will furnish to the other certificates of insurance as
evidence of the insurance required in both the foregoing and the
following paragraphs on or before the Effective Date and from time
to time upon request. Each party’s liability under this
Agreement shall not be limited to the amount of any insurance
coverage that it maintains. In addition to the foregoing, each
party shall maintain the following insurance coverages:
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(b)
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Additional Collection Center
Insurance Requirements: Collection Center shall maintain
Professional Liability insurance that is no less than
$1 million per occurrence and $3 million aggregate and
such insurance shall remain in force for at least three
(3) years following the end of the Term or a Subsequent
Term.
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(c)
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Additional Dendreon Insurance
Requirements: (1) Products/Clinical Trials Liability insurance
applicable to the manufacture of any clinical trial product of
Dendreon that uses the leukapheresis collections in an amount not
less than $5,000,000 per occurrence and the aggregate and such
Products/Clinical Trials Liability insurance shall; (i) name
the Collection Center Indemnitees as specified in this Agreement as
additional insureds; (ii) remain in effect for not less than
3 years after cessation of clinical trials related to this
Agreement; (2) As of the date of any sale or commercial use of
sipuleucel-T after market approval of the product, Products
Liability insurance in an amount not less than $10,000,000 per
occurrence and such Products Liability insurance shall,
(i) name the Collection Center Indemnitees as
additional
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insureds; and (ii) such
Products Liability insurance shall be maintained in force for not
less than five years after the last date of sale of sipuleucel-T.
With respect to insurance coverage requirements relative to clause
(c)(1), Dendreon intends to seek a clarifying endorsement from its
insurance provider stating that such Products/Clinical Trials
Liability insurance does not exclude from coverage claims in which
the theory of the claim is deficient, negligent or inadequate
design of the product or clinical trial, or other related
professional (Errors & Omissions) exposure.
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18.
Documentation of Compliance
Upon
Dendreon’s request no more than once during any twelve
(12) month period, absent cause, Collection Center shall
provide Dendreon with a copy of the Collection Center’s
license and an attestation that all Collection Center personnel
performing the Services are properly licensed as required by the
Legal Requirements.
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(a)
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Confidential Information. It is
anticipated that the parties will exchange Confidential Information
pursuant to the terms of this Agreement.
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(b)
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Receiving Party’s Limited Use
and Nondisclosure of Confidential Information. Each of Dendreon,
Collection Center and ARC shall use Confidential Information of the
other solely for the purpose of complying with the terms of this
Agreement. All Confidential Information shall remain the property
of the disclosing party and shall be kept confidential by the
receiving party and not disclosed to others except with the
disclosing party’s prior written consent. The receiving party
will maintain Confidential Information in strict confidence and
shall treat it with not less than the degree of care with which the
receiving party would treat the receiving party’s own
Confidential Information.
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(c)
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Exceptions. The confidentiality
obligations shall not apply to information that is subject to one
or more of the following circumstances:
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(i) the
information is now, or hereafter becomes, through no act or failure
to act on the part of the receiving party, generally known the
public;
(ii) the
information is furnished to the receiving party by a third party
that the receiving party reasonably believes is not prohibited from
disclosing such information by a contractual, legal or fiduciary
obligation;
(iii) the
information is properly in the possession of the receiving party
prior to its disclosure pursuant to this Agreement, as evidenced by
receiving party’s written records;(iv) the information is
independently d
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