<PAGE>
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.
Page - 1
<PAGE>
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
Page - 2
<PAGE>
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.
Page - 3
<PAGE>
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
Page - 4
<PAGE>
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.
Page - 5
<PAGE>
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.
Page - 6
<PAGE>
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.
Page - 7
<PAGE>
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
Page - 8
<PAGE>
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
Page - 9
<PAGE>
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.
Page - 10
<PAGE>
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.
Page
- 11
<PAGE>
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 - 12
<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:
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
[*]
[*] [*]
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[*] [*]
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[*]
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
