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EXHIBIT 10.5
CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
SERVICES AGREEMENT
FOR PRODUCTION AND RELEASE TESTING OF
ENCAPSULATED PORCINE XENOTRANSPLANT PRODUCTS
This Services Agreement for cGMP Manufacturing production and
release
testing of encapsulated porcine xenotransplant product for
MicroIslet, Inc. (the
"Agreement"), dated this 1st day of September 2007, is entered
into by and
between Progenitor Cell Therapy, LLC, having an address at 21
Main Street, Court
Plaza South, East Wing, Suite 304, Hackensack, New Jersey 07601
(hereinafter
called "PCT") and MicroIslet, Inc, having an address at 6370
Nancy Ridge Drive,
Suite 112 San Diego, CA 92121 (hereinafter called
"MICROISLET").
WHEREAS, MICROISLET ((MI) WWW.MICROISLET.COM) is a public
biotechnology company
engaged in the research, development and commercialization of
patented
technologies in the field of transplantation therapy for
patients with diabetes;
MICROISLET has licensed several technologies from Duke
University Medical Center
developed over the last decade for the isolation, culture,
storage and
encapsulation of insulin-producing porcine islet cells;
MICROISLET believes that
these proprietary methods are among the most important advances
in the field of
transplantation that may enable diabetic patients to become free
from insulin
injections; MICROISLET's ultimate goal is to offer a solution
towards a cure for
diabetes worldwide;
WHEREAS, PCT is a contract manufacturing organization dedicated
to the
manufacture, testing and delivery of cellular therapeutics, with
facilities in
Mountain View, California and Hackensack, New Jersey, holds a
California Drug
Manufacturing License for the conduct of clinical trial
manufacture and
distribution of cells products, is registered with the FDA as an
HCT/P facility,
and maintains cGMP Quality Systems compliant with applicable
United States
regulations;
NOW, THEREFORE, in consideration of the mutual covenants and
agreements
contained herein and other good and valuable consideration, the
receipt and
sufficiency of which is hereby acknowledged by each Party to the
other, the
Parties, intending to be legally bound, hereby covenant and
agree as follows:
TERMS
-----
As used in this Agreement the following terms shall have the
following
meanings:
AGREEMENT This Agreement including its attachments and
as the Agreement or its attachments,
including the Quality Agreement, may be
amended through Program Amendment Order.
APPLICABLE LAWS All laws, ordinances, rules, orders and
regulations of any state, federal or local
governmental or regulatory authority that
govern the Services or Product including,
without limitation, the United States
Federal Food, Drug and Cosmetic Act, HIPAA
and the regulations and guidelines of the
FDA and other Regulatory Agencies.
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
FDA Means the United States Food and Drug
Administration, or any successor agency
thereto.
FORCE MAJEURE Any cause beyond the reasonable control of
the Party in question which for the
avoidance of doubt and without prejudice to
the generality of the foregoing includes
governmental actions, war, riots, terrorism,
civil commotion, fire, flood, epidemic,
labor disputes (excluding labor disputes
involving the work force or any part thereof
of the Party in question), restraints or
delays affecting shipping or carriers, and
act of God.
CGMP Current Good Manufacturing Practice
regulations, as set forth in the United
States Code of Federal Regulations Title 21
(21 C.F.R. ss.ss. 210 and 211), as amended
from time to time, and subject to the
requirements set forth in the Quality
Agreement.
CGTP Current Good Tissue Practice regulations, as
set forth in the United States Code of
Federal Regulations Title 21 (21 C.F.R. ss.
1271 subpart 2), as amended from time to
time, and subject to the requirements set
forth in the Quality Agreement.
MANUFACTURE Means manufacture of the Product in
accordance with this Agreement, including
any amendments made thereto in accordance
with this Agreement.
POINT OF CONTACT Each Party shall appoint a Point
of Contact which will serve as that Party's
point of contact for the other Party, as
further detailed in Section 1 of this
Agreement.
PRODUCT Encapsulated porcine islet cell product or
any batch or unit thereof
PROGRAM Stages 1 through 5 of the Scope of Work as
outlined in Attachment A of this Agreement.
PROGRAM A document detailing changes to the Program,
AMENDMENT ORDER which has been agreed to and signed by both
Parties and is in the form attached to and
made a part of this Agreement as "Attachment
B". The elements and conditions of a Program
Amendment Order are described in Section 2,
Attachment B, and elsewhere in this
Agreement.
PROPOSAL The "Proposal by Progenitor Cell Therapy,
LLC to "Provide Contract Manufacturing
Support Services for MicroIslet, Inc. Ver 2"
dated August 3, 2007
QUALITY AGREEMENT The document agreed to by the Parties
which
sets forth and governs the roles and
responsibilities of each Party's personnel
in relation to quality assurance matters
relating to the transactions contemplated
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
under this Agreement, a copy of which is
attached to and made a part of this
Agreement as Attachment C (the "Quality
Agreement").
REGULATORY AGENCY Any relevant state, federal or local
governmental regulatory authority, within or
outside of the United States, involved in
regulating any aspect of the conduct,
development, manufacture, storage,
distribution, export, import, market
approval, sale, packaging or use of the
Services, the Program or the Product,
including the FDA.
SERVICES Those services, products, and reports to be
provided by PCT as expressly set forth and
more particularly described in Stages 1
through 5 of Attachment A to this Agreement
in accordance with the terms and conditions
set forth in this Agreement and all its
Attachments and in compliance with
Applicable Laws.
STAGE Each distinct step or stage of the Program
as described in Attachment A to this
Agreement.
TERMINATION This Agreement will terminate upon
completion of the Program by satisfactory
performance of the Service or upon
termination affected pursuant to section 7.
THIRD PARTY Any person other than the Parties or their
respective Affiliates.
1. SERVICES TO BE PERFORMED
------------------------
A. PCT shall furnish to MICROISLET the Services set forth in
Attachment
A which is attached hereto and incorporated herein by
reference.
B. PCT shall provide the required personnel and support
necessary to
perform the Services which shall be carried out primarily at
PCT's Mountain
View, California facility, located at 291 North Bernardo Avenue,
Mountain View,
California 94043.
C. PCT's point of contact at MICROISLET, with respect to the
Services
to be provided herein is Michael Andrews or any other party
designated in
writing by MICROISLET (hereinafter called "Point of
Contact").
D. MICROISLET's point of contact at PCT with respect to the
Services to
be provided herein is Stewart Craig, PhD, or another party
designated in writing
by PCT.
E. If there is any conflict between the terms of the Proposal,
the
Quality Agreement or this Agreement, the terms of this Agreement
shall control
and govern.
F. MICROISLET agrees to fulfill its responsibilities as set
forth in
the Quality Agreement and acknowledges and agrees that in order
for PCT to carry
out the Program, MICROISLET must satisfy its obligations under
this Agreement,
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
including the Quality Agreement. PCT agrees to fulfill its
responsibilities as
set forth in the Quality Agreement and acknowledges and agrees
that in order for
MICROISLET carry out its obligations, PCT must satisfy its
obligations under
this Agreement, including the Quality Agreement.
G. It shall not be considered a breach of this Agreement by
either
Party if a Party is unable to fulfill its obligation due to
action or inaction
by the other Party. The Parties hereby acknowledge and agree
that because the
work to be performed hereunder is by its nature developmental,
PCT can only
assure compliance with MICROISLET's specifications as outlined
in this Agreement
and makes no warranty or guaranty whatsoever regarding the
achievement of a
successful outcome for the Program.
2. PAYMENT FOR SERVICES
--------------------
A. MICROISLET shall pay to PCT, for Services as specified in
Stages 1
through 4 set forth in Attachment A, a total of [***] on the
following schedule:
DATE AMOUNT
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
B. MICROISLET agrees that all payments of the Program Charges
are due
thirty (30) days after the invoice dates as set forth above and
that any
payments which remains unpaid forty-five (45) calendar days
after the date when
due shall then begin to accrue interest at the annual rate of
[***] until paid
in full (the "Default Rate").
C. Any change in Program is subject to agreement in advance
through a
Program Amendment Order (PAO) in the form attached in Attachment
B. Regulatory
consulting, writing services, and attendance at meetings between
the FDA and
MICROISLET, other than those Services outlined in Stage 3 of the
Program, are
not included in the Services but are offered at the consulting
rates outlined in
Attachment A
D. PCT shall invoice MICROISLET in accordance with the payment
schedule
set forth in this section. Such invoices shall be forwarded to
the attention of
the Point of Contact, in paper form at the aforementioned
address or electronic
form by email.
E. MICROISLET shall reimburse PCT for all reasonable and
necessary
travel expenses to such places as PCT may travel in the
performance of such
Services as requested by MICROISLET. All travel is to be
approved in advance by
the MICROISLET Point of Contact. PCT shall provide an itemized
expense
statement, along with itemized receipts for such expenses on a
monthly basis.
Such itemized expense statements shall be forwarded to the
attention of the
Point of Contact, in paper form at the aforementioned address or
electronic form
by email.
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
F. MICROISLET shall reimburse PCT for reasonable and
necessary
materials and supplies required to perform the Services set
forth in Attachment
A and for such other services for and requested by MICROISLET.
PCT shall obtain
the prior approval of MICROISLET for any single purchase of
supplies or reagents
in excess of [***]. PCT shall provide an itemized expense
statement for such
expenses on a monthly basis. Such itemized expense statement
shall be forwarded
to the attention of the Point of Contact, in paper form at the
aforementioned
address or electronic form by email. Any materials or supplies
for which
MICROISLET has reimbursed PCT will be delivered to MICROISLET
upon completion of
the Services or termination of this Agreement, if so requested
by MICROISLET. A
[***] percent ([***]%) fee will be added to the total of each
monthly expense
reimbursement statement and a [***]% handling fee added to the
cost of any
shipment made by PCT to or at the request of MICROISLET.
MICROISLET shall pay
PCT for Services performed by PCT and expenses incurred by PCT
which are
properly documented and invoiced in accordance with this Section
2 and
Attachment A, within thirty calendar (30) days following receipt
of the
applicable invoice and/or itemized expense statement submitted
by PCT.
G. The Parties agree that any changes to this Agreement,
including a
change in the scope of work set forth in Attachment A, including
election of
additional work under Stage 5, must be made in writing in the
form of a Program
Amendment Order. The Parties recognize that changes to the scope
of work,
whether by way of increasing or decreasing the services to be
provided, may
result in corresponding changes to the timing or amount of the
payments that are
due to PCT.
H. [***] will be responsible for the costs of any Product
disposal as
may be required by the provisions of the Quality Agreement
attached hereto.
I. [***].
3. CONFIDENTIAL INFORMATION
------------------------
The Parties entered into a confidentiality agreement signed by
he last
of the Parties on 6 October 2007 (the "Confidentiality
Agreement"), attached
hereto as Attachment D, which governs the handling of
confidential information
between the Parties. PCT and MICROISLET ratify and affirm the
terms and
conditions contained in the Confidentiality Agreement and its
applicability to
this Agreement and hereby extend the term of the Confidentiality
Agreement to a
period of three (3) years following the termination or
expiration of this
Agreement.
Notwithstanding the foregoing or anything contained in the
Confidentiality
Agreement, nothing shall prohibit either Party from summarizing
the terms of
this Agreement, or from filing this Agreement as an exhibit, in
documents such
Party is required to file with any government agency, including
the Securities
and Exchange Commission; provided that such disclosure shall be
only to the
extent required to comply with applicable laws, and further
provided that the
Party proposing to make such disclosure shall provide a copy of
the proposed
disclosure to the other Party in advance of such disclosure, and
the Parties
shall mutually agree to the content of such disclosure. Except
as set forth in
this Section 3, to the extent that there is any discrepancy
between this
Agreement and the Confidentiality Agreement, the Parties agree
that the
provisions contained in the Confidentiality Agreement shall
prevail.
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
4. DISCLOSURE AND ASSIGNMENT OF INTELLECTUAL PROPERTY
--------------------------------------------------
A. PCT shall promptly disclose, in writing to MICROISLET all
patentable
and un-patentable inventions, ideas, discoveries, improvements,
design rights,
semiconductor mask works, works of authorship, copyrights, trade
secrets,
know-how and any equivalents thereof (hereinafter called
"INTELLECTUAL
PROPERTY") made, developed or conceived which arises out of the
Services
rendered pursuant to this Agreement or out of CONFIDENTIAL
INFORMATION of
MICROISLET provided to and/or acquired by PCT in connection with
this Agreement,
regardless of whether such information ceases to be Confidential
Information.
All such INTELLECTUAL PROPERTY shall be owned solely and
exclusively by and vest
entirely in MICROISLET.
B. PCT shall and does hereby irrevocably grant and assign to
MICROISLET
the entire assignable right, title and interest, without further
compensation,
in and to any and all of the INTELLECTUAL PROPERTY referred to
in Section 4(A)
above, together with: (i) the right to apply for patents and/or
copyright
registrations thereon in any and all countries of the world, and
(ii) the entire
right, title and interest in and to any and all applications for
patents and
copyright registrations which may be prepared or filed thereon
at MICROISLET's
discretion and expense, and in and to any and all of the
eventuating patents and
copyright registrations.
C. PCT agrees that all works of authorship shall be deemed
"works made
for hire" for MICROISLET within the meaning of the U.S.
Copyright Law, and if
they are held to not so qualify, all ownership rights thereto
will be
transferred to MICROISLET.
D. PCT, at MICROISLET's request, shall execute and deliver
to
MICROISLET all descriptions, applications, assignments and other
documents and
instruments in its possession necessary or proper to carry out
the provisions of
this Agreement; PCT shall be reimbursed at its then current
consulting rates or
at a mutually agreeable negotiated price plus out-of-pocket
expenses, and will
make best commercial business efforts to cooperate with and
assist MICROISLET or
its nominees in all reasonable ways and at all reasonable times,
including, but
not limited to, testifying in all legal proceedings, signing all
lawful papers
and in general performing all lawful acts reasonable, necessary
or proper, to
aid MICROISLET in obtaining, maintaining, defending and
enforcing all lawful
patent, copyright, trade secret, know-how and the like in the
United States and
elsewhere; and PCT shall maintain such information and
communications in
confidence as Confidential Information.
E. Nothing contained herein shall be construed to grant to PCT
any
rights to technology or any license under any patent, copyright
or trademark now
or hereinafter in existence except for the limited purposes set
forth herein.
5. RELATIONSHIP OF PARTIES
-----------------------
This Agreement does not create an employer-employee
relationship
between MICROISLET and PCT. PCT shall not hold itself out as an
agent or
representative of MICROISLET. PCT agrees that all services
herein shall be
rendered by it as an independent contractor, and PCT shall have
no authority to
negotiate or execute agreements on behalf of MICROISLET or
otherwise bind or
obligate MICROISLET in any manner. In addition, PCT shall not be
eligible to
participate in any employee benefit program of MICROISLET.
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
6. REPRESENTATIONS AND WARRANTIES
------------------------------
A. General Representations and Warranties. Each Party represents
and
warrants to the other that it has the necessary right and
authority to enter
into this Agreement and that to the best of its knowledge as of
the Effective
Date it is the rightful owner of all Intellectual Property it
purports to own.
Neither Party makes any representation or warranty to the other
except as
specified in this Agreement.
B. Representations and Warranties of PCT.
1) PCT hereby represents and warrants to MICROISLET that PCT
and
its employees, agents, sub-contractors and representatives
providing the services hereunder shall have reasonable
expertise
in the relevant subject matter, and shall perform its
obligations under this Agreement in a professional and
workman-like manner with due care.
2) Compliance by PCT. PCT's Mountain View, California
facility
shall operate in compliance with Applicable Laws and the
Quality
Agreement.
3) Permits. PCT shall obtain and maintain necessary permits,
licenses and authorizations as required under this Agreement
and
Applicable Laws with respect to the Services.
4) Personnel. Neither PCT, its subcontractors, agents nor
any
members of their respective staffs involved in providing the
Services shall be, at the time of performance of any
Services:
(i) disqualified or debarred by the FDA or any other
Regulatory
Agency for any purpose pursuant to 21 U.S.C. ss. 335a or any
foreign counterpart thereof; or (ii) convicted under United
States federal law or foreign counterpart thereof, for
conduct
relating to the development or approval, or otherwise
relating
to the regulation of, any drug under the Generic Drug
Enforcement Act of 1992 or any other relevant statute, law
or
regulation.
5) PCT represents and warrants that it is under no obligation
to
any third party that would interfere with its rendering to
MICROISLET consulting and product development services as
herein
defined or which would be inconsistent with any of its
representations or obligations during the terms of this
Agreement.
6) PCT represents and warrants that the Product will meet
the
specifications set out in this Agreement and the Attachments
and
amendments hereto.
7) Patents. In performing any of its work or carrying out
its
obligations under this Agreement, PCT shall not knowingly
infringe upon any United States or foreign copyright,
patent,
trademark, trade secret or other proprietary right, or
misappropriate any trade secret, of any third Party in any
manner that would cause any liability, loss or damage to
MICROISLET, and PCT represents and warrants that it has
neither
assigned nor otherwise entered into any agreement by which
it
purports to assign or transfer any right, title or interest
to
any technology or intellectual property right that would
conflict with its obligations under this Agreement.
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
C. Representations and Warranties of MICROISLET.
1) Compliance with Obligations. MICROISLET hereby represents
and
warrants to PCT that it shall perform its obligations under
this
Agreement in a professional manner with due care.
2) Compliance. MICROISLET shall obtain and maintain all
necessary
permits, licenses and authorizations as required under this
Agreement and by all Applicable Laws with respect to the
Manufacture and human clinical use of the Product.
3) Personnel. Neither MICROISLET, its subcontractors, agents
nor
any members of their respective staffs involved in the
Manufacture, package or storage of the Product shall be, at
the
time of performance of any such activity hereunder: (i)
disqualified or debarred by the FDA or any other Regulatory
Agency for any purpose pursuant to 21 U.S.C. ss. 335a or any
foreign counterpart thereof; or (ii) charged with or
convicted
under United States Federal law or foreign counterpart
thereof,
for conduct relating to the development or approval, or
otherwise relating to the regulation of, any drug under the
Generic Drug Enforcement Act of 1992 or any other relevant
statute, law or regulation.
4) Patents. In performing any of its work or carrying out
its
obligations under this Agreement, MICROISLET shall not
knowingly
infringe upon any United States or foreign copyright,
patent,
trademark, trade secret or other proprietary right, or
misappropriate any trade secret, of any third Party in any
manner that would cause any liability, loss or damage to
PCT,
and MICROISLET represents and warrants that it has neither
assigned nor otherwise entered into any agreement by which
it
purports to assign or transfer any right, title or interest
to
any technology or intellectual property right that would
conflict with its obligations under this Agreement.
5) Materials. All materials, reagents, and porcine islets
required
for the process can be sourced and are of a
grade/nature/origin
acceptable for cGMP use and for human administration
according
to all Applicable Laws and PCT's standards.
D. DISCLAIMER of Warranties. EXCEPT AS EXPRESSLY PROVIDED IN
THIS
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO THE
PRODUCT,
SERVICES AND PROGRAM TO BE SUPPLIED BY SUCH PARTY HEREUNDER AND
BOTH PARTIES
SPECIFICALLY DISCLAIM ALL EXPRESS OR IMPLIED REPRESENTATIONS OR
WARRANTIES WITH
RESPECT TO THE PRODUCT, SERVICES AND/OR PROGRAM, INCLUDING ANY
WARRANTY OF
MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE OR
NONINFRINGEMENT, OR ANY
IMPLIED WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OF
DEALING OR USAGE
OF TRADE.
7. DURATION AND TERMINATION
------------------------
A. Except for the obligations described in Sections 3, 4, 5 and
6
above, which shall survive termination of this Agreement, this
Agreement shall
be in effect for the period defined in Attachment A from the
Effective Date.
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
B. MICROISLET, at its option, may terminate this Agreement with
or
without cause upon submitting written notice to PCT. In the
event of termination
without cause, MICROISLET shall pay [***].
C. Should either party hereto fail to perform any non-monetary
material
term, condition or covenant of this Agreement or if either party
shall breach
any representation or warranty contained in this Agreement, then
upon written
notice of such failure from the other party, the party in breach
or default
shall have thirty (30) days from the date of notice to correct
the breach or
default, and upon failure to do so, this Agreement shall
automatically terminate
for cause.
It is understood that the Parties intend to discuss, pursuant
to
the provisions of this section, any alleged breach and its
remediation as soon
as it is known, and that such discussion shall not be a waiver
of the right to
terminate pursuant to this Agreement. For purposes of this
Agreement: (i) a
Substantial Breach shall be defined as a breach by a Party that
directly caused
a significant delay or obstacle that prevented the Non-Breaching
Party from
achieving a material goal or objective as contemplated under
this Agreement, and
shall also include a breach by MICROISLET for failure to pay PCT
any fees or
charges owed when due; and (ii) no breach that is caused or
contributed to by
the Non-Breaching Party or Force Majeure shall constitute a
Substantial Breach.
Upon termination for cause, the non-breaching Party shall be
entitled to pursue any and all remedies available to it at law
or in equity. In
addition, if MICROISLET is the non-breaching Party, in addition
to any other
available remedy, all obligations to make any payments pursuant
to this
Agreement shall cease with the exception of [***].
D. This Agreement may be automatically and immediately
terminated by
either Party, upon providing written notice to the other Party,
if the other
Party has a liquidator, receiver, manager receiver or
administrator appointed,
or ceases to continue trading or is unable to pay debts.
E. Termination under this Section 7 shall not relieve PCT's
obligations
under Sections 3, 4, 5 and 6 hereof, nor shall it relieve PCT
from any liability
arising from any breach of this Agreement.
8. INDEMNIFICATION & LIMITATION OF LIABILITY
-----------------------------------------
PCT shall indemnify, defend and hold harmless MICROISLET,
MICROISLET's
agents, servants and employees, from and against all claims,
damages, losses and
expenses, and liabilities of any nature whatsoever, including
reasonable
attorney's fees and disbursements (collectively, "Claims"),
incurred, caused,
based upon, arising out of or resulting from or failure to
perform, or
misrepresentation with respect to, any of the terms, covenants
or conditions of
this Agreement, except to the extent incurred, caused or
occasioned by, in
connection with or arising out of the acts or omissions of
MICROISLET and/or
MICROISLET's Agents including MICROISLET's violation or failure
to perform, or
misrepresentation with respect to, any of the terms, covenants
or conditions of
this Agreement.
Nothing in this Agreement shall be deemed to require PCT to
indemnify
MICROISLET for or with respect to any bodily injury caused by
the Product.
MICROISLET hereby acknowledges that it has exclusive control and
decision making
authority with respect to: (i) the specifications that govern
the Manufacture
and use of the Product, and (ii) specifications that govern the
Manufacture,
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CONFIDENTIAL TREATMENT REQUESTED BY MICROISLET, INC.
___________________
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND
FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
packaging and distribution of the Product. MICROISLET further
acknowledges that
PCT has no control over the "use" of the Product after being
shipped by PCT in
accordance with this Agreement.
MICROISLET shall defend, indemnify and hold PCT and PCT's
agents
harmless from and against any and all Claims incurred, caused or
occasioned by,
in connection with or arising out of (i) the Products, including
their use in
the treatment of human subjects; and (ii) any acts or omissions
of MICROISLET
and/or MICROISLET's agents, including MICROISLET's violation or
failure to
perform, or misrepresentation with respect to, any of the terms,
covenants or
conditions of this Agreement, except to the extent incurred,
caused or
occasioned by, in connection with or arising out of the acts or
omissions of PCT
and/or PCT's Agents including PCT's violation or failure to
perform, or
misrepresentation with respect to, any of the terms, covenants
or conditions of
this Agreement.
Each Party's indemnification obligations to the other Party
shall survive the
expiration or earlier termination of this Agreement.
NEITHER PARTY'S LIABILITY TO THE OTHER SHALL
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