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EXHIBIT 10.36
*CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE
24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
AGREEMENT
UNDER AN NIH
PRIME AWARD
This Agreement
("Agreement") is entered into this 10th day of February,
2006 by and between The Children's Hospital of Philadelphia ("CHOP")
and
Targeted Genetics Corporation (the "SUBAWARDEE").
WHEREAS, CHOP is the sub-recipient
of Contract No. HHSN266200500008C from
the National Institutes of Health ("NIH"), Department of Health and
Human
Services ("DHHS") for support of a project entitled "HIV Vaccine
Design and
Development Teams" (the "Prime Award") for which CHOP has
received a cost
reimbursement Subcontract ("Subcontract"); and
WHEREAS, the Subcontract includes
authorization for the collaboration
between CHOP and the SUBAWARDEE; and
WHEREAS, the SUBAWARDEE has the
skilled personnel and resources available
to perform the services contemplated by this Agreement in accordance with the
Subcontract and this Agreement and all applicable federal laws, regulations and
policies, including but not limited to the NIH Grants Policy Statement (NIH
Publication No. 99-8, March 2001, as may be amended, the "NIH Grants
Policy
Statement") that may be in effect from time to time.
NOW THEREFORE, the parties agree as
follows:
ARTICLE 1. STATEMENT OF WORK
SUBAWARDEE agrees to use diligent
efforts to perform the work described in
its Statement of Work, which is
attached as ATTACHMENT A and made part of
this Agreement. Any significant
change in the Statement of Work must be
approved by CHOP in advance, and
will be memorialized in an amendment to
this Agreement.
ARTICLE 2. PERIOD OF PERFORMANCE
The performance period for this
Agreement will be effective 31 August 2005
retroactively and will not extend
beyond 30 August 2006 unless the period
is extended by amendment to this
Agreement.
ARTICLE 3. KEY PERSONNEL
The CHOP Principal Investigator (the
"CHOP PI") for the Agreement is Philip
Johnson, M.D.
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The "Project Directors"
for the SUBAWARDEE will be Barrie J. Carter, PhD,
and Pervin Anklesaria, PhD. The
Project Directors will be responsible for
the conduct of the work performed
under this Agreement.
The Project Directors are considered
essential to the work to be performed.
The Project Directors may not be
replaced, on a temporary or permanent
basis, without the SUBAWARDEE first
providing CHOP with notice of such
request reasonably in advance along
with justification in sufficient detail
to permit evaluation of the impact
on the program and CHOP granting its
prior written approval.
Additionally, the Project Directors may not
significantly reduce his/her effort
without the prior written approval of
CHOP; for purposes of this
Agreement, a significant reduction of the
Project Directors effort is a
reduction of 25% or more compared to the
effort described in ATTACHMENT B.
ARTICLE 4. FINANCIAL CONDITIONS
4.1 ESTIMATED COSTS.
The total cost of this Agreement,
including direct and facilities and
administration costs, will not
exceed $3,087,023. ATTACHMENT B, which is
attached and made part of this
Agreement, reflects the agreed-upon budget.
Fixed fee payments will be
distributed based on the contract milestones
outlined in APPENDIX B. A fixed fee
of $51,634 will be paid to SUBAWARDEE
for each completed milestone. Total
fixed fee funds currently available for
payment and allotted to SUBAWARDEE
shall not exceed $154,901 (up to 3
milestones).
4.2 ALLOWABLE COSTS.
Allowability of costs will be
determined in accordance with the NIH Grants
Policy Statement and with applicable
Office Management and Budget (OMB)
cost principles.
4.3 INVOICING.
SUBAWARDEE will invoice CHOP no more
frequently than monthly and no less
frequently than quarterly for
services performed under this Agreement.
Invoices will be paid upon
certification by the CHOP PI that the work has
been completed. The final invoice
should be marked as such and SUBAWARDEE
should send the final invoice to
CHOP no later than thirty (30) days from
the expiration or termination of
this Agreement. If the final invoice is
received after that time, it may not
be honored.
Invoices should be prepared in
triplicate and sent to the Director,
Research Finance, The Joseph Stokes
Jr. Research Institute of The
Children's Hospital of Philadelphia,
3615 Civic Center Boulevard,
Philadelphia, PA 19104-4318 using
the format provided in ATTACHMENT C or
other format containing the same
information. Upon request, the SUBAWARDEE
will furnish CHOP with any necessary
documentation to support invoiced
amounts.
SUBAWARDEE assumes sole
responsibility for reimbursement to CHOP of a sum
of money equivalent to the amount of
any expenditure disallowed (as defined
by the applicable Federal
Acquisition Regulation) should CHOP or NIH rule,
through audit
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exception or some other appropriate
means, that any expenditure of funds
allocated to the SUBAWARDEE was not
made in compliance with the provisions
of this Agreement.
ARTICLE 5. REPORTING REQUIREMENTS
5.1 FINANCIAL
In addition to the final invoice, as
specified in Section 4.3 above, the
SUBAWARDEE will submit a financial
report on Form NIH 2706 within thirty
(30) days after the end of the
performance period.
5.2 PROGRAMMATIC
Reports of all programmatic findings
related to the project will be sent to
the CHOP PI when requested and in
time to be included in annual or periodic
reports and the final report to NIH.
In general, this will follow Appendix
A, flowdowns of the Prime Contract.
5.3 OTHER
SUBAWARDEE will provide CHOP with
documentation necessary to complete any
additional reports required by NIH
(such as human subject assurances,
program income or invention
statements).
ARTICLE 6. GENERAL CONDITIONS
This Agreement will be administered
in compliance with the provisions
herein and the SUBAWARDEE agrees to
comply with all applicable laws,
regulations and policies pertaining
to SUBAWARDEE's performance hereunder,
including but not limited to the
Contract, NIH Grants Policy Statement; 42
C.F.R. Section 52 et seq; 45 C.F.R.
Section 74 et seq.; 45 C.F.R. Section
92 et seq. (as appropriate for the
type of SUBAWARDEE and type of
activity); and any other laws,
regulations, or policies specifically
referenced in this Agreement as they
may be amended from time to time. The
provisions of this Agreement may
impose obligations on SUBAWARDEE in
addition to those imposed by the
Contract, NIH Grants Policy Statement and
other applicable regulations.
ARTICLE 7. SPECIAL CONDITIONS
7.1 AWARD SPECIFIC TERMS AND CONDITIONS
Subcontractor will comply with the
terms and conditions, and Contract
clauses identified as a flowdown
from the Prime Contract (APPENDIX A) and
Patent Rights Agreement (ATTACHMENT
D).
7.2 INVENTIONS, PATENTS, COPYRIGHTS AND
DATA
Inventions: The determination of
rights in ownership and disposition of
inventions resulting from the
performance of the Agreement and the
administration of such patents will
be in accordance with 37 CFR 401 and
SUBAWARDEE agrees to comply with
regulations regarding inventions as 37 CFR
Part 401.
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SUBAWARDEE will promptly disclose
any inventions resulting from the
performance of this Agreement to
CHOP and will cooperate with CHOP in
making required notifications to
NIH/DHHS.
Final Invention Report: SUBAWARDEE
agrees to submit Final Invention
Statement Form, HHS 568, to CHOP no
later than sixty (60) days after the
termination or expiration of this
Agreement.
Copyrights: Disposition of any
copyrights or any copyrightable material
will be determined by the policy of
the SUBAWARDEE. Any such copyrighted
materials are subject to a
royalty-free, non-exclusive, and irrevocable
license for the U.S. Government to
reproduce, publish, or otherwise use the
copyrighted material and to
authorize others to do so for federal purposes.
Copies of all copyrighted or
copyrightable materials will be provided to
the CHOP PI.
Data: SUBAWARDEE will own the data
it generates under this Agreement. For
the purposes or activities related
to the Agreement CHOP will have the
right to receive copies of such data
and use data for educational and
research purposes subject to the
terms of the Patent Rights Agreement
(Attachment D). Additionally,
SUBAWARDEE acknowledges the rights of the
U.S. Government to use such data.
7.3 PUBLICATION AND ACKNOWLEDGMENT OF
SUPPORT.
SUBAWARDEE is encouraged to publish
the results of its effort carried out
pursuant to this Agreement. In so
doing the SUBAWARDEE will comply with the
NIH's policies that pertain to the
title and disposition of Rights in Data,
Publication and Copyrighting as such
policies are set forth in the NIH
Grants Policy Statement and in HHSAR
352.270-6. Publication policies are
defined in Attachment D- Patent
Rights Agreement. The SUBAWARDEE will
provide an advance copy of every publication
involving data associated with
this agreement to the CHOP PI.
All publications, reports and other
materials resulting from the study will
acknowledge NIH support and should
use a statement to the effect:
"The project described was
supported by funds from The Children's Hospital
of Philadelphia under contract
number HHSN266200500008C from the National
Institute of Health/Department of
Health and Human Services and the content
of the publication do not necessarily
represent the views or policies of
the DHHS or The Children's Hospital
of Philadelphia," nor does mention of
trade names, commercial products, or
organizations imply endorsement by the
U.S. Government.
As required by Department of Health
and Human Services ("DHHS")
appropriations acts, all DHHS award
recipients must acknowledge Federal
funding when issuing statements,
press releases, requests for proposals,
bid invitations, and other documents
describing projects or programs funded
in whole or in part with Federal
money. Grantees are required to state (1)
the percentage and dollar amounts of
the total program or project costs
financed with Federal money and (2)
the percentage and dollar amount of the
total costs financed by
nongovernmental sources.
7.4 PROGRAMMATIC AND BUDGETARY CHANGES
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For all actions requiring NIH/DHHS
prior approval, SUBAWARDEE must obtain
prior written approval of CHOP.
SUBAWARDEE agrees to provide CHOP with
sufficient justification and
supporting materials to support the requested
change.
7.5 SALARY RATE LIMITATION
SUBAWARDEE is subject to Public Law
108-447, which stipulates that no NIH
fiscal year funds may be used to pay
the direct salary of an individual
through an award at a rate in excess
of:
<TABLE>
<S>
<C>
FY 2005 (Executive Level I)
January 1, 2005 through
December 31, 2005 $180,100
</TABLE>
(direct salary is exclusive of
overhead, fringe benefits and facilities and
administrative expenses.)
The SUBAWARDEE shall include the
following certification on every invoice
for reimbursable costs incurred with
Fiscal Year funds subject to the
salary rate limitation provisions as
specified in this Agreement. For
billing purposes, certified invoices
are required for the billing period
during which the applicable Fiscal
Year funds were initially charged
through the final billing period
utilizing the applicable Fiscal Year
funds:
"I hereby certify that the
salaries charged in this invoice are in
compliance with P.L. 108-447 and
ARTICLE 7.5 of the above referenced
Agreement."
ARTICLE 8. USE OF NAME
CHOP and SUBAWARDEE each agree not
to use the name of the other, or the
name of any staff of the other, in
news releases, commercial or
non-commercial advertising or in
other publications (with the exception of
scholarly publications), without the
prior written permission of a duly
authorized officer of the other
party and the affected individual (if any).
ARTICLE 9. AUDITS, INSPECTIONS AND RECORDS
SUBAWARDEE will comply with the
requirements of OMB Circular A-133 as
implemented by 45 C.F.R. Section
74.26 and 45 C.F.R. Section 92.26, (or the
audit requirements stated in 45
C.F.R. Section 74.26(d) for types of
organizations to which OMB A-133 or
other federal audit requirements does
not directly apply), as applicable.
SUBAWARDEE will submit a copy of its
most recent financial compliance and
audit report to the Director, Research
Finance, The Joseph Stokes Jr.
Research Institute of The Children's
Hospital of Philadelphia, 3615 Civic
Center Boulevard, Philadelphia, PA
19104-4318.
CHOP will have the right, at
mutually agreeable times and upon reasonable
notice, to inspect and review the
progress of work conducted by the
SUBAWARDEE hereunder, including the
right to inspect SUBAWARDEE's
facilities and records related to
work conducted by SUBAWARDEE hereunder.
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Financial records, supporting
documents, research data and other records
pertinent to this Agreement will be
retained for a period of three (3)
years from the date of submission of
CHOP's final expenditure report to
NIH. Records pertaining to audits,
appeals, litigation or settlement of
claims arising out of the
performance of this Agreement will be retained
until such audits, appeals or
litigation or claims have been settled.
ARTICLE 10. LIABILITY
The SUBAWARDEE's relationship to
CHOP under this Agreement will be that of
an Independent Contractor and not an
agent, joint venturer, partner or
employee of CHOP. As such an
independent contractor, the SUBAWARDEE assumes
risk and all responsibility for work
conducted under this Agreement. The
SUBAWARDEE will, during the course
of this Agreement, maintain in force
adequate insurance to cover risk or
liability arising out of this work.
ARTICLE 11. TERMINATION
This Agreement will immediately terminate upon
receipt of written
notification from CHOP to SUBAWARDEE
that the Contract has been terminated
by the funding agency or if CHOP
does not approve a replacement Project
Director as such approval is
required by Article 3 above. Furthermore, CHOP
may terminate this Agreement by
giving notice in writing to SUBAWARDEE if
SUBAWARDEE is in breach of this
Agreement and has failed to cure such
breach within thirty (30) days or
within a mutually agreed upon cure
period, of receipt of notice thereof
from CHOP.
ARTICLE 12. CHANGES
CHOP may from time to time request
changes in the scope of the activities
to be performed by the SUBAWARDEE as
described in ATTACHMENT A, Statement
of Work. Changes that are mutually agreed
upon between the SUBAWARDEE and
CHOP shall be incorporated into this
Agreement via written amendment(s).
ARTICLE 13. NOTICE
All notices required under this
Agreement shall be in writing and sent to:
To CHOP:
Assistant Director, Research
Services
Office of Research Services
and Project Development
The Children's Hospital of
Philadelphia
The Joseph Stokes, Jr.
Research Institute
3615 Civic Center Boulevard
Philadelphia, PA 19104-4318
Tel: (215) 590-3800
Fax: (215) 590-3804
Notices regarding
programmatic matters only should be sent to:
Philip Johnson, M.D.
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The Children's Hospital of
Philadelphia
The Joseph Stokes, Jr.
Research Institute
3615 Civic Center Boulevard
Philadelphia, PA 19104-4318
To SUBAWARDEE:
Ralph W. Paul, Ph.D
Director, Technology
Evaluation
Targeted Genetics
Corporation
1100 Olive Way, Suite 100
Seattle, WA 98101
Tel: (206) 521-7830
Fax: (206) 521-7830
With a copy sent to::
Legal Department
Targeted Genetics
Corporation
1100 Olive Way, Suite 100
Seattle, WA 98101
ARTICLE 14. ASSIGNMENT
This Agreement is for professional services.
Neither party may assign,
delegate or otherwise transfer any
of its rights or obligations under this
Agreement in whole or in part to
another party without the express written
consent of the non-assigning party.
SUBAWARDEE agrees not to subcontract
any of the research effort required
under this Agreement without the
prior written approval of CHOP.
ARTICLE 15. INDEMNIFICATION
15.1 INDEMNIFICATION BY SUBAWARDEE
SUBAWARDEE will indemnify and hold
harmless CHOP, its board members,
officers, agents, servants and
employees from and against any and all
liability, loss, damage, claims,
costs, actions, and suits, including
costs, expenses, and attorneys'
fees, arising out of, resulting from, or
relating to, directly or indirectly,
any action or inaction of the
SUBAWARDEE under this Agreement.
15.2 INDEMNIFICATION BY CHOP
CHOP will indemnify and hold
harmless SUBAWARDEE, its board members,
officers, agents, servants and
employees from and against any and all
liability, loss, damage, claims,
costs, actions and suits, including costs,
expenses, and attorneys' fees,
arising out of, resulting from, or relating
to, directly or indirectly, any action
or inaction of CHOP under this
Agreement.
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ARTICLE 16. ENTIRE AGREEMENT
This Agreement constitutes the
entire agreement and understanding between
CHOP and SUBAWARDEE. It merges all prior discussions between the parties
and neither party will be bound by
conditions, definitions, warranties,
understanding or representations
concerning such subject matter except as
provided in this Agreement. Any
changes or modifications to this Agreement
or to any attachment to this
Agreement will be made in writing and executed
by the duly authorized
representatives of CHOP and SUBAWARDEE.
ARTICLE 17. ASSURANCES AND CERTIFICATIONS
17.1 GENERAL
SUBAWARDEE will comply with all
applicable Public Policy Requirements and
Objectives as specifically described
in the Contract and NIH Grants Policy
Statement, which are hereby
incorporated into this Agreement by reference.
Furthermore, SUBAWARDEE represents,
warrants and certifies that it has
filed and will maintain all
assurances or other documentation with the
appropriate government agencies to
the extent such assurances and
documentation are required.
17.2 NON-DISCRIMINATION
SUBAWARDEE certifies that the
SUBAWARDEE is in compliance with the Civil
Rights Act of 1964, the Age
Discrimination Act of 1975, Title IX of the
Education Amendments of 1972; the
Rehabilitation Act of 1973; and the
Americans With Disabilities Act and
all implementing regulations.
17.3 DEBARMENT
SUBAWARDEE does certify that neither
SUBAWARDEE nor any of its employees or
agents performing any service under
this Agreement (including the
SUBAWARDEE PI) are presently
debarred, suspended, proposed for debarment,
declared ineligible or voluntarily
excluded from participation in this
transaction, under investigation for
a crime or otherwise engaged in
conduct for which a person can be
debarred by any federal agency, and
SUBAWARDEE will immediately notify
CHOP upon any inquiry concerning
commencement of any such proceeding
concerning SUBAWARDEE or such person
referred to in this subparagraph.
17.4 FEDERAL DEBT
SUBAWARDEE certifies that SUBAWARDEE
is not delinquent on any Federal debt
in accordance with OMB Circular No.
A-129.
17.5 LOBBYING
SUBAWARDEE certifies that no
federally appropriated funds have been paid or
will be paid to any person for
influencing or attempting to influence an
officer or employee of any agency, a
Member of Congress, an officer or
employee of Congress, or an employee
of an Member of Congress in connection
with this Agreement, and that if any
funds other than federally
appropriated funds have been paid or
will be paid to any person for
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influencing or attempting to
influence an officer or employee of any
agency, a Member of Congress, an
officer or employee of Congress, or an
employee of an Member of Congress in
connection with this NIH Prime award,
grant loan or cooperative agreement
the SUBAWARDEE will complete and submit
standard Form-LLL, "Disclosure
Form to Report Lobbying."
17.6 PROTECTION OF HUMAN SUBJECTS
The SUBAWARDEE will comply with all
requirements relating to human subject
protections as set forth at 45
C.F.R. Part 46 and 21 C.F.R. Part 50
(Protection of Human Subjects).
SUBAWARDEE agrees that it will
obtain the approval of the appropriate
external institutional review board
(the "IRB") prior to conducting any
studies involving human subjects and
will comply with all IRB policies and
requirements regarding such
research. SUBAWARDEE will notify CHOP
immediately if IRB approval of the
study has to be revoked or suspended for
any reason.
SUBAWARDEE certifies that the
cognizant IRB is in full compliance with all
relevant federal regulations. SUBAWARDEE
further agrees to notify CHOP
immediately of any actions taken by
the FDA or OHRP in relation to the IRB.
Unanticipated events, drug
reactions, or other reports of project activity
that could assist CHOP and other
subcontractors, if any, in protecting the
health or safety of study subjects
will be immediately reported to the CHOP
PI, in addition to reporting to the
extent required to the NIH and FDA, as
applicable.
17.7 VERTEBRATE ANIMALS
SUBAWARDEE will comply with all
federal government, Public Health Service,
and NIH requirements, policies, and
guidelines relating to the humane care
and use of laboratory animals
including but not limited to The Animal
Welfare Act as amended, at 7 U.S.C.
Section 2131 et. seq., and comply with
any local or state government laws,
regulations or policies concerning such
matters. In accordance with the
applicable regulations, SUBAWARDEE agrees
that any animal research protocol
conducted under this Agreement will be
reviewed and approved by
SUBAWARDEE's Animal Care and Use Committee (IACUC)
and certifies that this IACUC is in
full compliance with all federal
regulations and has an approved
Assurance on file with DHHS.
17.8 USE OF RECOMBINANT DNA
SUBAWARDEE agrees that, to the
extent applicable, it will comply with the
requirements of the NIH Guidelines
for Research Involving Recombinant DNA
Molecules (59 FR 34496, July 5,
1994) including establishing a standing
Institutional Biosafety Committee.
17.9 MISCONDUCT IN SCIENCE
SUBAWARDEE agrees to comply with
regulations at 42 C.F.R. Part 50, Subpart
A, "Responsibilities for PHS
Awards and Applicant Institutions for Dealing
with and Reporting Possible Misconduct
in Science"; immediately notify CHOP
if the conduct of
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any employee or agent of SUBAWARDEE
performing any service under this
Agreement, including the SUBAWARDEE
PI, is under investigation for
misconduct in science; and keep CHOP
fully informed about any such
investigation to enable CHOP to meet
its obligations under the NIH Grants
Policy Statement.
17.10 OBJECTIVITY IN RESEARCH
SUBAWARDEE will comply with all federal
government, Public Health Service,
and NIH requirements, policies, and
guidelines relating to actual or
potential conflicts of interest,
including but not limited to the
requirements of 42 C.F.R. Part 50,
Subpart F, "Responsibility of Applicants
for Promoting Objectivity in
Research for which NIH Funding is Sought".
Acceptance of this Agreement
constitutes certification that SUBAWARDEE has
implemented a written and enforced
policy consistent with the above
referenced policy and with any
subsequent amendments to this policy.
17.11 DRUG-FREE WORKPLACE
By signing this Agreement, the
SUBAWARDEE assures that it is in compliance
with the provisions of the Drug-Free
Workplace Act of 1988 (45 CFR Part 76,
Subpart F).
17.12 BIOTERRORISM PREPAREDNESS AND RESPONSE
The SUBAWARDEE will comply with the
Public Health Security and Bioterrorism
Preparedness and Response Act of
2002 (P.L. 107-188).
17.13 USA PATRIOT ACT
The SUBAWARDEE will comply with the
Uniting and Strengthening America by
Providing Appropriate Tools Required
to Intercept and Obstruct Terrorism
Act (USA PATRIOT Act P.L. 107-56).
17.14 INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION
The SUBAWARDEE will comply with the
"Standards for Privacy of Individually
Identifiable Health Information (45
C.F.R. 164 Subpart E)." This regulation
under the Health Insurance
Portability and Accountability Act (HIPAA) of
1996 governs the protection of
individually identifiable health
information.
17.15 STEM CELL RESEARCH
The SUBAWARDEE will comply with
"Notice of Criteria for Federal Funding of
Research on Existing Embryonic Stem
Cells and Establishment of NIH
Embryonic Stem Cell Registry"
(NOT-OD-02-005; 11/07101) and the "NIH
Guidelines for Research Using Human
Pluripotent Stem Cells."
17.16 CHANGES
SUBAWARDEE agrees to notify CHOP
immediately if there is any change of
status in any of the above.
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ARTICLE 18. ADDITIONAL DISCLOSURES
In addition to all other reporting
and notification requirements set forth
in this Agreement, the SUBAWARDEE
will immediately disclose to CHOP in
writing each of the following:
(a) The existence of any
"Significant Financial Interests" as defined in 42
C.F.R. Part 50, Subpart F,
"Responsibility of Applicants for Promoting
Objectivity in Research for which NIH
Funding is Sought," that are required
by such regulations to be reported
to NIH, along with an explanation as to
whether the identified Interest is
being managed, reduced or eliminated by
the SUBAWARDEE and any other
information about the Interest that CHOP may
reasonably request;
(b) Formal findings of noncompliance
with any law, regulation or other term
or condition incorporated into the
Agreement that could reasonably affect
the awarding, administration,
conduct, reliability or reporting of the
results of the Prime Award;
(c) Receipt of formal discovery
requests, notices of suit or litigation or
other formal adversary proceedings
with respect to any aspect of the
Agreement; and
(d) Suspensions, disciplinary
actions or other enforcement actions by an
external agency or authority that
concern any Investigator on the Agreement
and are related to that
Investigator's performance under the Agreement or
the Agreement itself. For purposes
of this Agreement, "Investigator" will
be as defined in the federal
regulations on "Responsibility of Applicants
for Promoting Objectivity in
Research for which PHS Funding is Sought"
(Conflicts of Interest), at 42
C.F.R. Part 50, Subpart F.
ARTICLE 19. GOVERNING LAW
This Agreement will be construed
under the laws of Pennsylvania.
APPENDIX A and ATTACHMENT D are hereby incorporated as part of this
subcontract.
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IN WITNESS WHEREOF, the parties have
caused this Agreement to be executed
by their duly authorized representatives.
For The Children's Hospital of
For Targeted Genetics Corporation
Philadelphia: SUBAWARDEE:
/s/ Sara Dubberly
/s/ Barrie Carter
------------------------------------
------------------------------------
Signature
Signature
Sara Dubberly Barrie Carter
Typed Name
Typed Name
Director, Sponsored Projects
Senior Executive Vice President and
Children's Hospital of Philadelphia
Chief Scientific Officer
The Joseph Stokes Jr. Research Institute
Targeted Genetics Corporation
------------------------------------
------------------------------------
Title/Organization
Title/Organization
Date 2/10/06
Date 2/13/06
Page
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<PAGE>
CHOP REFERENCE NO. 22852 -01-01
APPENDIX A - PRIME CONTRACT FLOWDOWNS
The Prime Contract clauses identified below are hereby incorporated by
reference. Furthermore, at a minimum, this Subcontract hereby incorporates by
reference any of those FAR and FAR Supplement clauses that are part of the
Prime
Contract.
When any of the clauses incorporated herein by reference specify a period of
time within which the contractor is to provide any notice, information, or
document to the Government, the Subcontractor must provide any such notice,
information, or document to CHOP within a sufficiently shorter time in order to
provide CHOP a reasonable opportunity to consider the Subcontractor's material
and prepare its own submission before the Prime Contract deadline.
As used in the Prime Contract clauses that are incorporated herein by
reference,
the term "contract" shall mean this Agreement, the terms
"Government,"
"Contracting Officer," and the like shall mean CHOP, the term
"Contractor" shall
mean the SUBAWARDEE.
PART I
SECTION A - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE A.1 PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise
Provided
Notwithstanding the clauses,
ALLOWABLE COST AND PAYMENT and FIXED FEE,
incorporated in this contract,
unless authorized in writing by the
Contracting Officer, the costs of
the following items or activities shall
be unallowable as direct costs:
(1)
Acquisition, by purchase or lease, of any interest in real property;
(2)
Special rearrangement or alteration of facilities;
(3)
Purchase or lease of ANY item of general purpose office furniture or
office equipment regardless of
dollar value. (General purpose
equipment is defined as any
items of personal property which are
usable for purposes other than
research, such as office equipment and
furnishings, pocket
calculators, etc.);
(4)
Travel to attend general scientific meetings;
(5)
Foreign travel - See Paragraph b.(2) below;
(6)
Consultant costs;
(7)
Subcontracts;
(8)
Patient care costs;
(9)
Accountable Government property (defined as both real and personal
property with an acquisition
cost of $1,000 or more and a life
expectancy of more than two
years) and "sensitive items" (defined and
listed in the Contractor's
Guide for Control of Government Property),
1990, regardless of acquisition
value.
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
b. Travel Costs
(1)
Domestic Travel
(a) Total expenditures for domestic travel
(transportation, lodging,
subsistence, and
incidental expenses) incurred in direct
performance of this
contract shall not exceed $43,022 without the
prior written approval of
the Contracting Officer.
(b) The
Contractor shall invoice and be reimbursed for all travel
costs in accordance with
Federal Acquisition Regulations (FAR)
31.205-46.
(2)
Foreign Travel
Requests for foreign travel
must be submitted at least six weeks in
advance and shall contain the
following: (a) meeting(s) and place(s)
to be visited, with costs and
dates; (b) name(s) and title(s) of
Contractor personnel to travel
and their functions in the contract
project; (c) contract purposes to be
served by the travel; (d) how
travel of Contractor personnel
will benefit and contribute to
accomplishing the contract
project, or will otherwise justify the
expenditure of NIH contract
funds; (e) how such advantages justify the
costs for travel and absence
from the project of more than one person
if such are suggested; and (f)
what additional functions may be
performed by the travelers to
accomplish other purposes of the
contract and thus further
benefit the project.
ARTICLE A.2. ADVANCE UNDERSTANDINGS
Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.
a. To negotiate a cost reimbursement
type subcontract with Children's Hospital
of Philadelphia for an amount not to
exceed $18,902,433. Award of the
subcontract shall not proceed
without the prior written approval of the
Contracting Officer upon review of
the draft subcontract agreement. After
written approval of the subcontract
by the Contracting Officer, a copy of
the signed, approved subcontract
shall be provided to the Contracting
Officer.
b. To negotiate a cost reimbursement
type lower tier subcontract with Targeted
Genetics Corporation for an amount
not to exceed $18,243,919. Award of the
lower tier subcontract shall not
proceed without the prior written approval
of the Contracting Officer upon
review of the draft subcontract agreement.
After written approval of the
subcontract by the Contracting Officer, a
copy of the signed, approved lower
tier subcontract shall be provided to
the Contracting Officer.
c. Targeted Genetics Corporation is
authorized to bill indirect costs as
follows for the period August 31,
2005 through August 30, 2010: Fringe
Benefits of 13.02% of salaries and
wages; Overhead of 100% of direct labor
plus fringe benefits; and G&A of
14.93% of Direct Labor, Fringe Benefits,
Overhead and Other Direct Costs.
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
In no event shall the final amount
reimbursable for Overhead for the
Targeted Genetics Corporation exceed
a ceiling of 100% of direct labor and
fringe benefits.
d. To negotiate fixed price type lower
tier subcontracts with Targeted
Genetics Corporation for the
following amounts not to exceed:
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
Award of the lower tier
subcontracts shall not proceed without the
prior written approval of the
Contracting Officer upon review of the
draft subcontract agreements.
After written approval of the
subcontracts by the Contracting
Officer, a copy of the signed,
approved lower tier
subcontracts shall be provided to the Contracting
Officer.
e. Invoices - Cost and Personnel
Reporting, and Variances from the Negotiated
Budget
(1)
The Contractor agrees to provide a detailed breakdown on invoices of
the following cost categories:
(a) Direct Labor - List individuals by name,
title/position,
hourly/annual rate, level
of effort, and amount claimed.
(b) Fringe Benefits - Cite rate and amount.
(c) Overhead - Cite rate and amount.
(d) Materials & Supplies - Include detailed
breakdown when total
amount is over $1,000.
(e) Travel - Identify travelers, dates,
destination, purpose of trip,
and amount. Cite COA, if
appropriate. List separately, domestic
travel, general scientific
meeting travel, and foreign travel.
[*]CONFIDENTIAL TREATMENT REQUESTED.
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
(f) Subcontracts - Attach subcontractor
invoice(s).
(g) Equipment - Cite authorization and amount.
(h) Other Direct Costs
(i) Patient Care Costs
(j) G&A - Cite rate and amount.
(k) Total Cost
(l) Fixed Fee
(m) Total CPFF
Monthly invoices must include the
cumulative total expenses to date,
adjusted (as applicable) to show any
amounts suspended by the Government.
(2)
The Contractor agrees to immediately notify the Contracting Officer in
writing if there is an
anticipated overrun (any amount) or unexpended
balance (greater than 10
percent) of the amount allotted to the
contract, and the reasons for
the variance. Also refer to the
requirements of the Limitation
of Funds and Limitation of Cost Clauses
in the contract.
f. Confidential Treatment of Sensitive
Information
The Contractor shall guarantee
strict confidentiality of the
information/data that it is provided
by the Government during the
performance of the contract. The
Government has determined that the
information/data that the Contractor
will be provided during the
performance of the contract is of a
sensitive nature.
Disclosure of the information/data,
in whole or in part, by the Contractor
can only be made after the
Contractor receives prior written approval from
the Contracting Officer. Whenever
the Contractor is uncertain with regard
to the proper handling of
information/data under the contract, the
Contractor shall obtain a written
determination from the Contracting
Officer,
g. Contract Number Designation
On all correspondence submitted
under this contract, the Contractor agrees
to clearly identify the two contract
numbers that appear on the face page
of the contract as follows:
Contract No. HHSN266200500008C
ADB Contract No. N01-AI-50008
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
h. NIH NIAID DAIDS-contracted Audit of
Production Facility
The Contractor and all
Subcontractors will be audited for GMP, GLP, and
QC/QA capabilities within three
months of contract award. Noted
deficiencies shall be corrected (or
addressed) within three months after
issuance of the audit report.
i. Contract Milestones
The Contractor shall complete all
work in accordance with the Statement of
Work and the contract milestones set
forth below. The distribution of the
fixed fee shall be paid in
installments based on the Project Officer's
written certification regarding the
completion of these milestones as
follows:
<TABLE>
<CAPTION>
MILESTONES FIXED
FEE
----------
---------
<S> <C>
Multi-gene HIV VRP
Vaccine for Phase I
1
Immunogenicity testing
$38,028
2
Selection of VRP construct and mfg process $38,028
3
Pass DAIDS-contracted GMP audit of production facility intended for use
in
VRP production.
$38,028
4
Submit clinical trial concept to HVTN
$38,028
5
Prepare/submit pre-IND documents to CBER $38,028
6
Complete pilot lot production
$38,028
7
Technology transfer for GMP production $38,028
8
Pre-IND meeting
$38,028
9
Complete GMP production
$38,028
10 Complete GMP immunogenicity
testing
$38,028
11 Develop clinical trial protocol with
HVTN
$38,028
12 Complete QC release testing for GMP
product $38,028
13 Complete pivotal toxicology
study
$38,028
14 Prepare/submit IND
$38,028
15 Complete Phase I clinical trial $38,028
Multi-gene HIV VRP
Vaccine for Phase II
</TABLE>
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
<TABLE>
<S>
<C>
16 Review and prepare summary of
critical data
$38,028
17 Begin GMP production
$38,028
18 Develop clinical trial protocol with
HVTN
$38,028
19 Complete QC release testing for GMP
product
$38,028
20 Prepare/submit IND amendment
$38,028
21 Begin Phase II clinical trial
$38,028
22 Review Phase II data
$38,028
</TABLE>
SECTION B - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK
ARTICLE B.1. REPORTING REQUIREMENTS AND DELIVERABLES
The Contractor is required to formally report progress once per year, through
submission of a written Technical Report, and once by holding a formal Site
Visit review to be attended by appropriate NIAID contract staff and program
officials, and the External Advisory Committee of the Team. The Contractor is
also required to submit Goals and Milestones Achievement Reports during the
contract period at appropriate times. Distribution of written reports is listed
in Article E.1.
GOALS AND MILESTONES ACHIEVEMENT REPORTS. SINCE THE PAYMENT OF CONTRACT FEE
PORTIONS WILL BE TIED TO THE ACCOMPLISHMENT OF NEGOTIATED, PREDETERMINED GOALS
AND MILESTONES, THE CONTRACTOR WILL SUBMIT GOALS AND MILESTONES ACHIEVEMENT
REPORTS DURING THE CONTRACT PERIOD AS APPROPRIATE. THE ORIGINAL SHALL BE
SUBMITTED TO THE CONTRACTING OFFICER, AND TWO (2) COPIES (ONE HARD COPY AND A
COPY IN A DIGITAL MEDIUM) TO THE PROJECT OFFICER. EACH REPORT MUST CONSIST OF:
1.
A COVER PAGE.
2.
Reports shall include but not be limited to the following:
Section A - An
introduction covering the goal or milestone.
Section B - A description
of the results. Description shall
include pertinent data
and/or figures in sufficient detail to
explain any significant
results from analysis and scientific
evaluation of data
accumulated to date under the goal or
milestone. When
appropriate this report should detail specific
requests and approvals for
the conduct of human trials.
Clinical Trials Protocol(s). NIAID has a responsibility to ensure that
mechanisms and procedures are in place to protect the safety of participants in
NIAID-supported studies. Therefore, as described in the NIAID Clinical Terms of
Award and Guidance (http://www.niaid.nih.gov/ncn/clinical/default_human.htm),
the Contractor shall develop a protocol for each clinical trial and submit it
for approval by the NIAID Prevention
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
Science Review Committee (PSRC). Protocols should include a description of the
research design and protocol development including definition of objectives and
approaches, planning, implementation, participant recruitment and follow-up,
data collection, quality control, data and safety monitoring, final data
analysis and interpretation, and publication of results. Final approval of this
protocol must take place prior to participant enrollment. [For trials to be
conducted through the DAIDS-sponsored HVTN, the protocol should be developed in
conjunction with the HVTN.]
Annual Technical Report. By the
fifteenth working day of the twelfth month
of each contract year, the
Contractor shall submit Annual Technical
Progress Reports as described below.
The original shall be submitted to the
Contracting Officer, and two (2)
copies (one hard copy and one copy in a
digital medium) to the Project
Officer. The report should be factual and
concise and consist of the
following:
1. A cover page.
2. Reports shall include, but not be
limited to the following:
Section A - An introduction
covering the purpose and scope of the
contract effort.
Section B - A description of
overall progress plus a separate
description for each task or
other logical segment of work on which
effort was expended during the
reporting period. The description shall
include pertinent data and/or
figures in sufficient detail to explain
any significant results from
analysis and scientific evaluation of
data accumulated to date under
the project. Special emphasis shall be
placed on goals or milestones
that were reached, or problems that were
encountered that prevented
reaching a scheduled goal or milestone
during the reporting period and
how those problems were/will be
addressed, and requests and
approvals to conduct human trials.
Section C - A summary of the
proposed goals and milestones for the
duration of the contract,
including any proposed revisions based on
results generated to date.
Annual Site Visit Review and Report. At the middle (6 month mark) of each
contract year, the Contractor shall host, for NIAID contract and program staff
and their External Advisory Board, a site visit review. The Contractor's
Principal Investigator and all Co-investigators shall attend this meeting. An
update and summary of results generated on each sub-project shall be presented
by the co-investigator and/or other pertinent staff. These presentations shall
include summaries of all goals or milestones reached during the review period
and include a description of all problems encountered that will impact the
achievement of particular goals and milestones as outlined in the Contractor's
research plan. The Principal Investigator, Co-investigator and staff
representing each project and sub-project shall describe goals and milestones
and development objectives for the coming year. Additionally, application of
the
policies and procedures for monitoring the direction of specific projects shall
be presented. For Contractors with foreign subcontracts, this annual site visit
will also report details about approvals for manufacturing or testing that have
been obtained from both the U.S. and foreign governments. A report of the plan
for, and results of, this site visit shall be prepared by
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
the Contractor and submitted to the Project Officer (in hard copy and digital
medium) and the Contracting Officer (original hard copy).
Final Technical Report. The Contractor shall submit the final report documents,
two (2) copies (one hard copy and one copy in a digital medium) to the Project
Officer, and the original to the Contracting Officer, which shall summarize the
results of the entire contract work for the complete performance period, and
shall include the specifications of the optimized AIDS vaccine product
developed
during the course of this contract. These specifications shall include: 1) the
identity of the vaccine strain or strains in the final product, 2) a detailed
description of the manipulations used in the vaccine design, 3) a detailed
description of all processes used to expand, attenuate, inactivate, or purify
the final vaccine product, 4) a detailed description of any adjuvants or other
potentiating agents used in the delivery of the final optimized product, 5) a
detailed description of the suggested immunization schedule to be used for
optimal reactivity in humans, and 6) evidence that the vaccine product can be
manufactured under GMP/GLP conditions for use in human vaccine trials. In
addition, the Contractor shall indicate whether any INDs were filed in relation
to vaccine products developed during the course of the contract, and provide a
description of the IND and the results of the filings. For Contractors with
foreign subcontracts, this report shall include details concerning approvals
for
manufacturing or testing that have been obtained for or by the foreign
subcontractors. The final report shall be submitted by the completion date of
the contract.
Deliverables. The Contractor shall submit samples of candidate HIV/AIDS
vaccines, as well as selected plasma/cell samples from preclinical animal
immunogenicity studies of candidate HIV/AIDS vaccines, prior to GMP
manufacture,
for testing in DAIDS-sponsored core laboratories. Contractors may also be asked
to provide samples of GMP vaccine product for similar analyses in conjunction
with clinical trials.
ARTICLE B.2. INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR Clause 52.227-11 including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Extramural
Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986).
In addition, one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer. The final
invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted to the
Contracting Officer within 90 days after the expiration date of the contract to
the following address:
Contracting Officer
National Institutes of Health
National Institute of Allergy and
Infectious Diseases, CMP
6700-B Rockledge Drive, Room 3214,
MSC 7612
Bethesda, Maryland 20892 -7612
If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the address listed above.
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
To assist Contractors in complying with invention reporting requirements of the
clause, the NIH has developed "Interagency Edison," an electronic
invention
reporting system. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is
through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (http://www.iedison.gov), or by
contacting the Extramural Inventions and Technology Resources Branch, OPERA,
NIH.
SECTION C - PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and contractor name. The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.
SECTION D - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly
authorized representative will perform
inspection and acceptance of
materials and services to be provided.
b. For the purpose of this SECTION, the
Project Officer is the authorized
representative of the Contracting
Officer.
c. Inspection and acceptance will be
performed at the address listed in
Article G.1.
Acceptance may be presumed unless
otherwise indicated in writing by the
Contracting Officer or the duly
authorized representative within 30 days of
receipt.
d. This contract incorporates the
following clause by reference, with the same
force and effect as if it were given
in full text. Upon request, the
Contracting Officer will make its
full text available.
FAR Clause No. 52.246-9, INSPECTION
OF RESEARCH AND DEVELOPMENT (SHORT
FORM) (APRIL 1984).
SECTION E - DELIVERIES OR PERFORMANCE
ARTICLE E.1. DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in Attachment A and upon delivery and
acceptance by the Contracting Officer, or the duly authorized representative,
of
the following items in accordance with the stated delivery schedule:
a. The items specified below as
described in SECTION B, ARTICLE B.1 will be
required to be delivered F.O.B.
Destination as set forth in FAR 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES
(APRIL 1984), and in
accordance with and by the dates
specified below:
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
<TABLE>
<CAPTION>
Item Description Delivery Schedule
---- ----------- -----------------
<S> <C>
<C>
1
Goals and Milestones Achievement Report
As required by the Project Officer
2
Clinical Trials Protocol(s)
As required by the Project Officer
3
Annual Technical Report
15th day of the twelfth month of each
contract year
4
Annual Site Visit Review and Report
6th month of each contract year
5
Final Technical Report
On or before contract expiration
</TABLE>
b. The above items shall be addressed
and delivered to:
<TABLE>
<CAPTION>
Addressee Deliverable Item Quantity
---------
----------------
--------
<S>
<C>
<C>
Contracting Office Goals and
Milestones Achievement Report --
CMP, NIAID, NIH Clinical
Trials Protocol(s) --
Room 3214, MSC 7612 Annual
Technical Report 1
Copy
6700-B Rockledge Drive Annual
Site Visit Review and Report 1
Copy
Bethesda, MD 20892-7612 Final
Technical Report 1
Copy
Project Officer Goals and
Milestones Achievement Report 1 Copy*
Vaccine & Prevention Research
Clinical Trials Protocol(s) 1 Copy*
Program Annual
Technical Report 1
Copy*
Division of AIDS, NIAID, NIH Annual
Site Visit Review 1
Copy*
Room 5136, MSC 7628 Final
Technical Report 1 Copy*
6700-B Rockledge Drive
Bethesda, MD 20892-7628
</TABLE>
* Plus one copy on 3.5 inch, high
density computer diskette or other digital
medium approved by the Project
Officer.
ARTICLE E.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the sane
force and effect as if it were given in full text. Upon request, the
Contracting
Officer will make its full text available. Also, the full text of a clause may
be accessed electronically at this address: http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST
1989) with ALTERNATE I (APRIL 1984).
SECTION F - CONTRACT ADMINISTRATION DATA
ARTICLE F.1 PROJECT OFFICER
The following Project Officer will represent the Government for the purpose of
this contract:
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
Michael N. Pensiero, Ph.D. Product Development Team Leader
Preclinical Research and Development
Branch Vaccine and Prevention Research
Program Division of AIDS, NAID, NIH,
DHHS Room 5136, MSC 7628 6700-B
Rockledge Drive Bethesda, MD
20892-7628
Phone: (301) 435-3749 Fax: (301)
402-3684
Email: mpensiero@niaid.nih.gov
The Project Officer is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance
and
recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
The Contracting Officer is the only person with authority to act as agent of
the
Government under this contract. Only the Contracting Officer has authority to:
(1) direct or negotiate any changes in the Statement of Work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.
The Contracting Officer hereby delegates the Project Officer as the Contracting
Officer's authorized representative responsible for signing software license
agreements issued as a result of this contract.
The Government may unilaterally change its Project Officer designation.
ARTICLE F2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in Section I of this
contract,
the following individuals are considered to be essential to the work being
performed hereunder:
<TABLE>
<CAPTION>
NAME TITLE
---- -----
<S>
<C>
Philip Johnson, M.D. Principal
Investigator (Children's Hospital of
Philadelphia)
K. Reed Clark, Ph.D. Co- Principal
Investigator (Children's Research
Institute)
Barrie Carter, Ph. D.
Co-Investigator (Targeted Genetics)
Pervin Anklesaria, Ph.D.
Co-Investigator (Targeted Genetics)
</TABLE>
ARTICLE F.3. GOVERNMENT PROPERTY
a. In addition to the requirements of
the clause, GOVERNMENT PROPERTY,
incorporated in SECTION I of this
contract, the Contractor shall comply
with the provisions of DHHS
Publication, Contractor's Guide for Control of
Government Property, 1990, which is
incorporated into this contract by
reference. Among other issues, this
publication provides a summary of the
Contractor's responsibilities
regarding purchasing authorizations and
inventory and reporting requirements
under the contract.
<PAGE>
APPENDIX A - PRIME CONTRACT FLOWDOWNS
CHOP REFERENCE NO. 22852 -01-01
A copy of this publication is
available upon request to the Contracts
Property Administrator.
Requests for information regarding
property under this contract should be
directed to the following office:
Division of Personal Property
Services, NIH
6011 Building, Suite 637
6011 EXECUTIVE BLVD MSC 7670
BETHESDA MD 20852-7670
(301) 496-6466
b. Notwithstanding the provisions
outlined in the DHHS Publication,
CONTRACTOR'S GUIDE FOR CONTROL OF
GOVERNMENT PROPERTY, 1990 which is
incorporated in this contract in
paragraph a. above, the Contractor shall
use the form entitled, "Report of
Government Owned, Contractor Held
Property" for performing annual
inventories required under this contract.
This form is included as an
attachment in SECTION J of this contract.
c.






