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
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
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
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
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:
FY 2005 (Executive Level I)
January 1, 2005 through December 31, 2005 $180,100
(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
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
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
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
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
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
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
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
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.
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.
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.
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
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:
MILESTONES FIXED FEE
---------- ---------
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
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
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
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
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
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.
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:
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
Item Description Delivery Schedule
- ---- ----------- -----------------
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
b. The above items shall be addressed and delivered to:
Addressee Deliverable Item Quantity
- --------- ---------------- --------
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
* 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:
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:
NAME TITLE
---- -----
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)
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.
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. Contractor-Acquired Government Property - Schedule I-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract,
the Contractor is hereby authorized to acquire the property listed in the
attached Schedule I-A, Attachment 8, for use in direct performance of the
contract. This contract is for scientific research and is with a nonprofit
institution whose primary purpose is the conduct of scientific research.
Therefore, in accordance with the clause, GOVERNMENT PROPERTY, ALTERNATE I,
title to equipment having an acquisition cost of less than $ 5,000 shall
vest in the Contractor and title to equipment having an acquisition cost of
$ 5,000 or more purchased with funds made available under the contract
shall vest in the Contractor subject to the provisions of the clause,
GOVERNMENT PROPERTY; provided that the Government may direct transfer of
the title to the Government or to a third party within twelve months after
completion or termination of the contract. The transfer of title to such
equipment to the Government or to a third party shall not be the basis for
any claim against the Government by the Contractor.
ARTICLE F.4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
a. Contractor Performance Evaluations
Interim and final evaluations of Contractor performance will be prepared on
this contract in accordance with FAR 42.15. The final performance
evaluation will be prepared at the time of completion of work. In addition
to the final evaluation, interim evaluations will be prepared annually to
coincide with the anniversary date of the contract.
Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. If agreement cannot be reached
between the parties, the matter will be referred to an individual one level
above the Contracting Officer, whose decision will be final.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
Copies of the evaluations, Contractor responses, and review comments, if
any, will be retained as part of the contract file, and may be used to
support future award decisions.
SECTION G - SPECIAL CONTRACT REQUIREMENTS
ARTICLE G.1. RESTRICTION FROM USE OF HUMAN SUBJECTS
NOTICE: UNDER GOVERNING REGULATIONS, FEDERAL FUNDS ADMINISTERED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES SHALL NOT BE EXPENDED FOR RESEARCH
INVOLVING HUMAN SUBJECTS, AND INDIVIDUALS SHALL NOT BE ENROLLED IN SUCH
RESEARCH, WITHOUT PRIOR APPROVAL BY THE OFFICE FOR HUMAN RESEARCH PROTECTIONS
(OHRP) OF AN ASSURANCE TO COMPLY WITH THE REQUIREMENTS OF 45 CFR 46 TO PROTECT
HUMAN RESEARCH SUBJECTS. THIS RESTRICTION APPLIES TO ALL COLLABORATING SITES
WITHOUT OHRP-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN, AND COMPLIANCE
MUST BE ENSURED BY THE AWARDEE.
PRISONERS SHALL NOT BE ENROLLED IN ANY HHS RESEARCH ACTIVITIES UNTIL ALL
REQUIREMENTS OF HHS REGULATIONS AT 45 CFR PART 46, SUBPART C HAVE BEEN MET. IF A
RESEARCH SUBJECT BECOMES A PRISONER DURING THE PERIOD OF THIS CONTRACT, 45 CFR
PART 46, SUBPART C WILL APPLY TO RESEARCH INVOLVING THAT INDIVIDUAL.
ARTICLE G.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators receiving NIH contract awards for research involving human
subjects. For a complete description of the NIH Policy announcement on required
education in the protection of human subject participants, the Contractor should
access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at
the following website:
http://grants.nih.gov/garants/guide/notice-files/NOT-OD-00-039.html. The
information below is a summary of the NIHPolicy Announcement:
The Contractor shall maintain the following information: (1) a list of the names
and titles of the Principal Investigator and any other individuals working under
the contract who are responsible for the design and/or conduct of the research;
(2) the title of the education program(s) in the protection of human subjects
that has been completed for each named personnel and; (3) a one sentence
description of the educational program(s) listed in (2) above. This requirement
extends to investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or consultants under
the contract.
Prior to any substitution of the Principal Investigator or any other individuals
responsible for the design and/or conduct of the research under the contract,
the Contractor shall provide the following written information to the
Contracting Officer: the title of the education program and a one sentence
description of the program that has been completed by the replacement.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
ARTICLE G.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS
The Contractor is directed to the full text of the NIH Policy regarding Data and
Safety Monitoring and Reporting of Adverse Events, which may be found at the
following web sites:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
THE CONTRACTOR MUST COMPLY WITH THE NIH POLICY CITED IN THESE NIH ANNOUNCEMENTS,
THE NIAID CLINICAL TERMS OF AWARD
(HTTP://WWW.NIAID.NIH.GOV/NCN/CLINIEALL/DEFAULT HUMAN.HTM), AND ANY OTHER DATA
AND SAFETY MONITORING REQUIREMENTS FOUND ELSEWHERE IN THIS CONTRACT.
Data and Safety Monitoring shall be performed in accordance with the approved
Data and Safety Monitoring Plan.
The Data and Safety Monitoring board and plan shall be established and approved
prior to beginning the conduct of the clinical trial.
ARTICLE G.4. HUMAN MATERIALS
The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable State and Local laws and the provisions of the
Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.
ARTICLE G.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos for
research purposes; or (2) research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury or death
greater than that allowed for research on fetuses in utero under 45 CFR
46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)). The term "human embryo or embryos" includes any organism, not
protected as a human subject under 45 CFR 46 as of the date of the
enactment of this Act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes or human diploid
cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVER
-------------------------- ----------- ------------
P.L. 108-447, Title
V-General Provisions,
Section 509 2005 10/1/04-9/30/05
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
ARTICLE G.6. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds
shall not be used to carry out any program of distributing sterile needles
or syringes for the hypodermic injection of any illegal drug.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVER
-------------------------- ----------- ------------
P.L. 108-447, Title
V-General Provisions,
Section 505 2005 10/1/04-9/30/05
ARTICLE G.7. PRIVACY ACT
This procurement action requires the Contractor to do one or more of the
following: design, develop, or operate a system of records on individuals to
accomplish an agency function in accordance with the Privacy Act of 1974, Public
Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations.
Violation of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records applicable to this project is Number
09-25-0200. This document may be accessed on the Internet at the following URL:
http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm.
ARTICLE G.8. ANIMAL WELFARE
All research involving live, vertebrate animals shall be conducted in accordance
with the Public Health Service Policy on Humane Care and Use of Laboratory
Animals. This policy may be accessed at
http://rantsl.nih.gov/grants/olaw/references/phspol.htm.
ARTICLE G.9. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS
UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE
(PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS
WITHOUT PRIOR APPROVAL BY THE OFFICE OF LABORATORY ANIMAL WELFARE (OLAW), OF [AN
ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY
ANIMALS AND/OR A VALID INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
APPROVAL]. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES (e.g. COLLABORATING
INSTITUTIONS, SUBCONTRACTORS, SUBGRANTEES) WITHOUT OLAW-APPROVED ASSURANCES,
WHETHER DOMESTIC OR FOREIGN.
ARTICLE G.10. SUBCONTRACTING PROVISIONS
a. Small Business Subcontracting Plan
(1) The Small Business Subcontracting Plan, dated March 7, 2005 is
attached hereto and made a part of this contract.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
(2) The failure of any Contractor or subcontractor to comply in good faith
with FAR Clause 52.219-8, entitled "Utilization of Small Business
Concerns" incorporated in this contract and the attached
Subcontracting Plan, will be a material breach of such contract or
subcontract and subject to the remedies reserved to the Government
under FAR Clause 52.219-16 entitled, "Liquidated
Damages-Subcontracting Plan."
b. Subcontracting Reports
(1) Subcontracting Report for Individual Contracts, SF-294
The Contractor shall submit the original and one (1) copy of
Subcontracting Report for Individual Contracts, SF-294 in accordance
with the instructions on the report as referenced in Public Law
95-507, Section 211. In addition to the information contained in the
General Instructions on the back of this form for Block 17, "Remarks,"
the Contractor shall provide an explanation for any category of small
business subcontracting for which there were no dollars reported since
the last reporting period.
Regardless of the effective date of this contract, the Report shall be
submitted on the following dates for the entire life of this contract:
April 30th
October 30th
The Report shall be sent to the Contracting Officer at following
address:
Contracting Officer
Contracts Management Program
National Institutes of Allergy and Infectious Diseases
6700B Rockledge Dr.
Room 3124, MSC 7612
Bethesda, MD 20892-7612
(2) Summary Subcontract Report, SF-295
The Contractor shall submit two (2) copies of Summary Subcontract
Report, SF-295 in accordance with the instructions on the report as
referenced in Public Law 95-507, Section 211. Regardless of the
effective date of this contract, the Summary Subcontract Report shall
be submitted annually on the following date for the entire life of
this contract:
October 30th
One copy of this report shall be sent to the Contracting Officer at
the address above. One copy of this Report shall be mailed to the
Office of Small and Disadvantaged Business Utilization, DHHS at the
following addresses:
Office of Small and Disadvantaged Business Utilization Department
of Health and Human Services
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
Hubert H. Humphrey Bldg., Room 517-D
200 Independence Avenue, S.W.
Washington, D.C. 20201
(3) The Contractor shall also send an "Information Copy" of the SF-295 to
the Cognizant Commercial Representative (CMR) at the address provided
by the SBA. The Contractor should call SBA Headquarters in Washington,
DC at (202) 606-4000, X234 for the correct address if unknown.
ARTICLE G.11. SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year
funds may be used to pay the direct salary of an individual through this
contract at a rate in excess of applicable amount shown for the fiscal year
covered. Direct salary is exclusive of fringe benefits, overhead, and
general and administrative expenses (also referred to as "indirect cost" or
"facilities and administrative (F&A) costs"). Direct salary has the same
meaning as the term "institutional base salary." An individual's direct
salary (or institutional base salary) is the annual compensation that the
Contractor pays for an individual's appointment whether that individual's
time is spent on research, teaching, patient care or other activities.
Direct salary (or institutional base salary) excludes any income that an
individual may be permitted to earn outside of duties to the Contractor.
The per year salary rate limit also applies to individuals proposed under
subcontracts. It does not apply to fees paid to consultants. If this is a
multiple year contract, it may be subject to unilateral modifications by
the Government if an individual's salary rate exceeds any salary rate
ceiling established in future HHS appropriation acts.
DOLLAR AMOUNT
OF SALARY
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR LIMITATION
-------------------------- ----------- -----------------
P.L. 108-447, Title II-General Provisions,
Section 204 2005 Executive Level I
c. Direct salaries are limited to the Executive Level I rate which was in
effect on the date(s) the expense was incurred.
LINK to EXECUTIVE LEVEL SALARIES: www.opm.gov/oca/PAYRATES/index. htm (Click on
"Executive Schedule" for the current Fiscal Year's salary rate or scroll down to
the "General Schedule Salary Tables from Previous Years" to locate the Executive
Level salary rates from previous years.)
ARTICLE G.12. PUBLICATION AND PUBLICITY
The Contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds
from the National Institute of Allergy and Infectious Diseases,
National Institutes of
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
Health, Department of Health and Human Services, under Contract No.
HHSN266200500008C, ADB No. NO1-AI-50008."
ARTICLE G.13. PRESS RELEASES
a. Pursuant to Public Law(s) cited in paragraph b., below, the Contractor
shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (1) the percentage
of the total costs of the program or project which will be financed with
Federal money; (2) the dollar amount of Federal funds for the project or
program; and (3) the percentage and dollar amount of the total costs of the
project or program that will be financed by nongovernmental sources.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVER
-------------------------- ----------- -----------------
P.L. 108-447, Title V-General Provisions,
Section 506 2005 10/1/04 - 9/30/05
ARTICLE G.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
ARTICLE G.15. ANTI -LOBBYING
a. Pursuant to Public Law(s) cited in paragraph c., below, contract funds
shall only be used for normal and recognized executive-legislative
relationships. Contract funds shall not be used, for publicity or
propaganda purposes; or for the preparation, distribution, or use of any
kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support or defeat legislation pending before the
Congress or any State legislature, except in presentation to the Congress
or any State legislature itself.
b. Contract funds shall not be used to pay salary or expenses of the
Contractor or any agent acting for the Contractor, related to any activity
designed to influence legislation or appropriations pending before the
Congress or any State legislature.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
c. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVER
-------------------------- ----------- -----------------
for a., above: P.L. 108-447, Title V
- General Provisions, Section 503a 2005 10/1/04 - 9/30/05
for b., above: P.L. 108-447, Title V
- General Provisions, Section 503b 2005 10/1/04 - 9/30/05
ARTICLE G.16. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Unique research resources arising from NIH-funded research are to be shared with
the scientific research community. NIH provides guidance, entitled, "Sharing
Biomedical Research Resources: Principles and Guidelines for Recipients of NIH
Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64
FR 72090]), concerning the appropriate terms for disseminating and acquiring
these research resources. This guidance, found at:
http://ott.od.nih.gov/NewPages/64FR72090.pdf. is intended to help Contractors
ensure that the conditions they impose and accept on the transfer of research
tools will facilitate further biomedical research, consistent with the
requirements of the Bayh-Dole Act and NIH funding policy.
Note: For the purposes of this Article, the terms, "research tools," "research
materials," and "research resources" are used interchangeably and have the same
meaning.
ARTICLE G.17. SHARING RESEARCH DATA
The data sharing plan submitted by the Contractor is acceptable. The Contractor
agrees to adhere to its plan and shall request prior approval of the Contracting
Officer for any changes in its plan.
The NIH endorses the sharing of final research data to expedite the translation
of research results into knowledge, products, and procedures to improve human
health. This contract is expected to generate research data that must be shared
with the public and other researchers. NIH's data sharing policy may be found at
the following Web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.htm1.
NIH recognizes that data sharing may be complicated or limited, in some cases,
by institutional policies, local IRB rules, as well as local, state and Federal
laws and regulations, including the Privacy Rule (see HHS-published
documentation on the Privacy Rule at http://www.hhs.govlocro. The rights and
privacy of people who participate in NIH-funded research must be protected at
all times; thus, data intended for broader use should be free of identifiers
that would permit linkages to individual research participants and variables
that could lead to deductive disclosure of the identity of individual subjects.
ARTICLE G.18. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS
RESULTING FROM NIH-FUNDED RESEARCH
The Policy requests that beginning May 2, 2005, NIH-funded investigators submit
to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an
electronic version of the author's final manuscript, upon acceptance for
publication, resulting from research supported in whole or in part with direct
costs from NIH. NIH defines the author's final manuscript as the
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
final version accepted for journal publication, and includes all modifications
from the publishing peer review process. The PMC archive will preserve
permanently these manuscripts for use by the public, health care providers,
educators, scientists, and NIH. The Policy directs electronic submissions to the
NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.
Additional information is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html.
PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE 1.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
A. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. DATE TITLE
- ---------- ---- -----
52.202-1 Jul 2004 Definitions (Over $ 100,000)
52.203-3 Apr 1984 Gratuities (Over $ 100,000)
52.203-5 Apr 1984 Covenant Against Contingent Fees (Over $ 100,000)
52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government (Over $ 100,000)
52.203-7 Jul 1995 Anti-Kickback Procedures (Over $ 100,000)
52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper
Activity (Over $ 100,000)
52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity (Over $
100,000)
52.203-12 Jun 2003 Limitation on Payments to Influence Certain Federal Transactions (Over
$ 100,000)
52.204-4 Aug 2000 Printed or Copied Double-Sided on Recycled Paper (Over $ 100,000)
52.204-7 Oct 2003 Central Contractor Registration
52.209-6 Jan 2005 Protecting the Government's Interests When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment (Over $
25,000)
52.215-2 Jun 1999 Audit and Records - Negotiation (Over $ 100,000)
52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format
52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $ 500,000)
52.215-14 Oct 1997 Integrity of Unit Prices (Over $ 100,000)
52.215-15 Oct 2004 Pension Adjustments and Asset Reversions
52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB)
other than Pensions
52.215-19 Oct 1997 Notification of Ownership Changes
52.215-21 Oct 1997 Requirements for Cost or Pricing Data or Information Other Than Cost or
Pricing Data - Modifications
52.216-7 Dec 2002 Allowable Cost and Payment
52.216-8 Mar 1997 Fixed Fee
52.219-8 May 2004 Utilization of Small Business Concerns (Over $ 100,000)
52.219-9 Jan 2002 Small Business Subcontracting Plan (Over $ 500,000)
52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $ 500,000)
52.222-2 Jul 1990 Payment for Overtime Premium (Over $ 100,000) (Note: The dollar amount
in paragraph (a) of this clause is $ 0 unless otherwise specified in
the contract.)
52.222-3 Jun 2003 Convict Labor
52.222-21 Feb 1999 Prohibition of Segregated Facilities
52.222-26 Apr 2002 Equal Opportunity
52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans, Veterans of the
Vietnam Era, and other Eligible Veterans
52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
52.222-37 Dec 2001 Employment Reports on Special Disabled Veterans, Veterans of the
Vietnam Era, and other Eligible Veterans
52.223-6 May 2001 Drug-Free Workplace
52.223-14 Aug 2003 Toxic Chemical Release Reporting (Over $ 100,000)
52.225-1 Jun 2003 Buy American Act - Supplies
52.225-13 Mar 2005 Restrictions on Certain Foreign Purchases
52.227-1 Jul 1995 Authorization and Consent, Alternate I (Apr 1984)
52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright Infringement (Over
$ 100,000)
52.227-11 Jun 1997 Patent Rights - Retention by the Contractor (Short Form) (Note: In
accordance with FAR 27.303(a)(2), paragraph (f) is modified to include
the requirements in FAR 27.303(a)(2)(i) through (iv). The frequency of
reporting in (i) is annual.
52.227-14 Jun 1987 Rights in Data - General
52.232-9 Apr 1984 Limitation on Withholding of Payments
52.232-17 Jun 1996 Interest (Over $ 100,000)
52.232-20 Apr 1984 Limitation of Cost
52.232-23 Jan 1986 Assignment of Claims
52.232-25 Oct 2003 Prompt Payment, Alternate I (Feb 2002)
52.232-33 Oct 2003 Payment by Electronic Funds Transfer--Central Contractor Registration
52.233-1 Jul 2002 Disputes
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985)
52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim
52.242-1 Apr 1984 Notice of Intent to Disallow Costs
52.242-3 May 2001 Penalties for Unallowable Costs (Over $ 500,000)
52.242-4 Jan 1997 Certification of Final Indirect Costs
52.242-13 Jul 1995 Bankruptcy (Over $ 100,000)
52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2 Aug 1998 Subcontracts, Alternate II (Aug 1998) *If written consent to
subcontract is required, the identified subcontracts are listed in
ARTICLE B, Advance Understandings.
52.244-5 Dec 1996 Competition in Subcontracting (Over $ 100,000)
52.244-6 Dec 2004 Subcontracts for Commercial Items
52.245-5 May 2004 Government Property (Cost-Reimbursement, Time and Material, or
Labor-Hour Contract)
52.246-23 Feb 1997 Limitation of Liability (Over $ 100,000)
52.249-6 Sep 1996 Termination (Cost-Reimbursement)
52.249-14 Apr 1984 Excusable Delays
52.253-1 Jan 1991 Computer Generated Forms
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. DATE TITLE
- ---------- ---- -----
352.202-1 Jan 2001 Definitions - with Alternate paragraph (h) (Jan 2001)
352.216-72 Oct 1990 Additional Cost Principles
352.228-7 Dec 1991 Insurance - Liability to Third Persons
352.232-9 Apr 1984 Withholding of Contract Payments
352.233-70 Apr 1984 Litigation and Claims
352.242-71 Apr 1984 Final Decisions on Audit Findings
352.270-5 Apr 1984 Key Personnel
352.270-6 Jul 1991 Publications and Publicity
352.270-7 Jan 2001 Paperwork Reduction Act
End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - Rev. 07/2005.
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. OF THIS SECTION IS HEREBY MODIFIED AS FOLLOWS:
FAR Clause 52.216-11, Cost Contract--No Fee (April 1984) is deleted in its
entirety and FAR Clause 52.216-8 Fixed Fee (March 1997) is substituted therefor.
FAR Clause 52.232-17, Interest (June 1996) is added.
FAR Clause 52.232-20, Limitation Of Cost (April 1984), is deleted in its
entirety and FAR Clause 52.232-22, Limitation Of Funds (April 1984) is
substituted therefor. [NOTE When this
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
contract is fully funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no
longer apply and FAR Clause 52.232-20, LIMITATION OF COST will become
applicable]
Alternate I (July 1985) of FAR Clause 52.245-5, Government Property
(Cost-Reimbursement, Time-And-Material, Or Labor-Hour Contracts) (January 1986)
is deleted.
FAR Clause 52.249-5, Termination For Convenience Of the Government (Educational
And Other Non-Profit Institutions) (April 1984) is deleted in its entirety and
FAR Clause 52.249-6, Termination (Cost-Reimbursement) (May 1986) is substituted
therefor.
HHSAR Clause 352.249-14, Excusable Delays (April 1984) is deleted in its
entirety and FAR Clause 52.249-14, Excusable Delays (April 1984) is substituted
therefor.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
Contracting Officer will make their full text available.
A. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
(1) FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone
Small Business Concerns (July 2005).
"(c) Waiver of evaluation preference.
[ ] Offeror elects to waive the evaluation preference."
(2) FAR Clause 52.224-1, Privacy Act Notification (April 1984).
(3) FAR Clause 52.224-2, Privacy Act (April 1984).
(4) FAR Clause 52.227-14, Rights in Data - General (June 1987).
(5) FAR Clause 52.230-2, Cost Accounting Standards (April 1998).
(6) FAR Clause 52.230-6, Administration of Cost Accounting Standards
(April 2005)
(7) FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001).
(8) FAR Clause 52.251-1, Government Supply Sources (April 1984).
B. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CHAPTER 3) CLAUSES:
(1) HHSAR 352.223-70, Safety and Health (JANUARY 2001). [This clause is
provided in full text in SECTION J - ATTACHMENTS.]
(2) HHSAR 352.270-8, Protection of Human Subjects (March 2005).
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
(3) HHSAR 352.270-9, Care of Live Vertebrate Animals (March 2005).
C. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
(3) NIH(RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).
(4) NIH(RC)-11, Research Patient Care Costs (4/1/84).
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:
THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
PART III
LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.
2. Annual Technical Progress Report Format for Each Study, July 1994, 1 page.
3. Safety and Health, HHSAR Clause 352.223-70, (1/01), 1 page.
4. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.
5. Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.
6. Government Property - Schedule I-A, 1 page.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
INCLUSION ENROLLMENT REPORT
This report format should NOT be used for data collection from study
participants
Study Title: ________________________
Total Enrollment: ___________________ Protocol Number: _______________________
Contract Number: ____________________
PART A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date
(Cumulative) by Ethnicity and Race
Sex/Gender
-------------------------------------------------
Ethnic Category Females Males Unknown or Not Reported Total
--------------- ------- ----- ----------------------- -----
Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals not reporting ethnicity)
Ethnic Category: Total of All Subjects*
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or not reported
Racial Categories: Total of All Subjects*
PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to
Date (Cumulative)
Racial Categories Females Males Unknown or Not Reported Total
--------------- ------- ----- ----------------------- -----
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or not reported
Racial Categories: Total of Hispanics or
Latinos**
* These totals must agree
** These totals must agree
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
ANNUAL TECHNICAL PROGRESS REPORT FORMAT FOR EACH STUDY
Study Title: ________________________
Date: _______________________________
Provide the number of subject enrolled in the study to date according to the
following categories:
American Black, White,
Indian or Asian or not of not of Other
Alaskan Pacific Hispanic Hispanic or
Native Islander Origin Hispanic Origin Unknown Total
--------- -------- -------- -------- -------- ------- -----
Female
Male
Unknown
TOTAL
Subpopulations of the minority groups should also be reported, using a similar
format.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001)
(a) To help ensure the protection of the life and health of all persons, and to
help prevent damage to property, the Contractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken additional safety
measures as the Contracting Officer in conjunction with the project or
other appropriate officer, determines to be reasonably necessary. If
compliance with these additional safety measures results in an increase or
decrease in the cost or time required for performance of any part of work
under this contract, an equitable adjustment will be made in accordance
with the applicable "Changes" Clause set forth in this contract.
(c) The Contractor shall maintain an accurate record of, and promptly report to
the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for
which the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by
the Contractor.
(e) The Contractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or operations.
Compliance with the provisions of this clause by subcontractors will he the
responsibility of the Contractor.
(End of clause)
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
PROCUREMENT OF CERTAIN EQUIPMENT
Notwithstanding any other clause in this contract, the Contractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed in
the following Federal Supply Groups, regardless of the dollar value, without the
prior written approval of the Contracting Officer.
67 - Photographic Equipment
69 - Training Aids and Devices
70 - General Purpose ADP Equipment, Software, Supplies and Support
(Excluding 7045-3 ADP Supplies and Support Equipment.)
71 - Furniture
72 - Household and Commercial Furnishings and Appliances
74 - Office Machines and Visible Record Equipment
77 - Musical Instruments, Phonographs, and Home-type Radios
78 - Recreational and Athletic Equipment
When equipment in these Federal Supply Groups is requested by the Contractor and
determined essential by the Contracting Officer, the Government will endeavor to
fulfill the requirement with equipment available from its excess personal
property sources, provided the request is made under a contract. Extensions or
renewals of approved existing leases or rentals for equipment in these Federal
Supply Groups are excluded from the provisions of this article.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
RESEARCH PATIENT CARE COSTS
(a) Research patient care costs are the costs of routine and ancillary services
provided to patients participating in research programs described in this
contract.
(b) Patient care costs shall be computed in a manner consistent with the
principles and procedures used by the Medicare Program for determining the
part of Medicare reimbursement based on reasonable costs. The Diagnostic
Related Group (DRG) prospective reimbursement method used to determine the
remaining portion of Medicare reimbursement shall not be used to determine
patient care costs. Patient care rates or amounts shall be established by
the Secretary of HHS or his duly authorized representative.
(c) Prior to submitting an invoice for patient care costs under this contract,
the contractor must make every reasonable effort to obtain third party
payment, where third party payors (including Government agencies) are
authorized or are under a legal obligation to pay all or a portion of the
charges incurred under this contract for patient care.
(d) The contractor must maintain adequate procedures to identify those research
patients participating in this contract who are eligible for third party
reimbursement.
(e) Only those charges not recoverable from third party payors or patients and
which are consistent with the terms and conditions of the contract are
chargeable to this contract.
APPENDIX A - PRIME CONTRACT FLOWDOWNS CHOP REFERENCE NO. 22852 -01-01
GOVERNMENT PROPERTY - SCHEDULE I-A
List
Forma CryoPlus freezer $9,176
REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY
CONTRACTOR __________________________ CONTRACT NUMBER ________________________
ADDRESS _____________________________ REPORT DATE: ___________________________
_____________________________ FISCAL YEAR: ___________________________
BEGINNING OF
CLASSIFICATION PERIOD ADJUSTMENTS END OF PERIOD
- -------------- ------------- --------------------------------- -------------
ITEMS VALUE GFP ADDED CAP ADDED DELETIONS #ITEMS VALUE
----- ----- --------- --------- --------- ------ -----
LAND>=$ 25K
LAND<$ 25K
OTHER REAL>=$ 25K
OTHER REAL< $ 25K
PROPERTY UNDER
CONSTR>=$ 25K
PROPERTY UNDER
CONSTR<$ 25K
PLANT EQUIP>=$ 25 K
PLANT EQUIP<$ 25 K
SPECIAL TOOLING>=$ 25K
SPECIAL TOOLING<$ 25K
SPECIAL TEST EQUIP>=$ 25K
SPECIAL TEST EQUIP<$ 25K
AGENCY PECULIAR>=$ 25K
AGENCY PECULIAR<$ 25K
MATERIAL>=$ 25K
(CUMULATIVE)
PROPERTY UNDER
MFR>=$ 25K
PROPERTY UNDER
MFR<$ 25K
SIGNED BY: DATE SIGNED:
-------------------------- -------------
APPENDIX B - AGREEMENT MILESTONES CHOP REFERENCE NO. 22852 -01-01
The SUBAWARDEE shall complete all work in accordance with the Statement of Work
and the milestones set forth below. The distribution of the fixed fee shall be
paid in installments based on CHOP's written certification regarding the
completion of these milestones as follows:
MILESTONES FIXED FEE
---------- ---------
Multi-gene HIV VRP Vaccine for Phase I
1 Selection of VRP construct and mfg process $51,634
2 Pass DAIDS-contracted GMP audit of production
facility intended for use in VRP production. $51,634
3 Submit clinical trial concept to HVTN $51,634
4 Prepare/submit pre-IND documents to CBER $51,634
5 Complete pilot lot production $51,634
6 Technology transfer for GMP production $51,634
7 Pre-IND meeting $51,634
8 Complete GMP production $51,634
9 Develop clinical trial protocol with HVTN $51,634
10 Complete QC release testing for GMP product $51,634
11 Complete pivotal toxicology study $51,634
12 Prepare/submit IND $51,634
13 Complete phase I clinical trial $51,634
Multi-gene HIV VRP Vaccine for Phase II
14 Review and prepare summary of critical data $51,634
15 Begin GMP production $51,634
16 Develop clinical trial protocol with HVTN $51,634
17 Complete QC release testing for GMP product $51,634
18 Prepare/submit IND amendment $51,634
19 Begin Phase II clinical trial $51,634
20 Review Phase II data $51,634
ATTACHMENT A
STATEMENT OF WORK
TARGETED GENETICS CORPORATION
Independently, and not as an agent of the Children's Hospital of Philadelphia,
Targeted Genetics Corporation (TGC), (the Sub-contractor) shall use its
commercial reasonable efforts to furnish all the necessary services, qualified
personnel, materials, equipment, and facilities, not otherwise provided by the
Government, Columbus Children's Research Institute (CCRI), or Children's
Hospital of Philadelphia (CHOP), under the terms of this contract, as needed to
perform the work set forth below.
SPECIFICALLY, THE SUB-CONTRACTOR SHALL:
1. Provide expertise for the selection of a specific vaccine concept and
provide the necessary personnel, scientific expertise, process
development, cGMP production, clinical, and regulatory expertise
required for the targeted development effort culminating in the
production and clinical testing of a promising AIDS vaccine candidate.
2. Have in place all the necessary qualified personnel (Pages 85 to 90 of
the HVDDT Technical Proposal for RFP NIH-NIAID-DAIDS-04-42, hereafter
"The Technical Proposal"), physical plant (Pages 94-95 of The
Technical Proposal), and clinical trial design and implementation
experience (Pages 73-75 of The Technical Proposal) to carry out all
work described in this statement.
3. The specific work to be conducted by the sub-contractor prior to GMP
manufacturing is as follows:
a. Generate suitable quantities of recombinant AAV (rAAV) vectors
for research and preclinical studies using a plasmid transfection
protocol. These rAAV preparations will meet or exceed all
requisite quantity, quality, purity, and potency parameters
required for these applications. The details of this work are
described on pages 26 to 28 of The Technical Proposal.
b. In preparation for large scale manufacture of rAAV vectors,
optimize the Adenovirus-hybrid (Ad-hybrid) method for rAAV1
(recombinant AAV serotype 1) production and generate a viral seed
for vaccine constructs, as described on pages 28-29 of The
Technical Proposal.
c. Provide appropriate outside vendors with materials from the rAAV1
purification process for characterization analyses of the
purification process and demonstration of Adenovirus (Ad)
clearance during purification as described on page 32 and 59-60
of The Technical Proposal. Monitor the analyses and incorporate
findings into a production process document to be transferred for
GMP manufacturing.
Page 1
ATTACHMENT A
STATEMENT OF WORK
TARGETED GENETICS CORPORATION
d. Generate packaging lines for rAAV serotype 2 (rAAV2) and rAAV1
HIV Clade B antigen expressing vectors as described on pages 30
-31 of The Technical Proposal. Characterize these packaging lines
for their suitability for use in large scale GMP manufacturing as
required for attainment of subsequent milestones in the program.
e. Develop appropriate upstream and downstream processes for the
production, purification, and final formulation compositions for
the rAAV1 and rAAV2 Clade B antigen expressing vectors, as
described on pages 31 and 32 of The Technical Proposal.
f. Provide the appropriate outside vendor rAAV1 Clade B antigen
expressing vectors for a rabbit biodistribution study which will
be conducted and analyzed as described on pages 43-47 of The
Technical Proposal. Part of the analysis will require the
development of a limit of detection polymerase chain reaction
assay (LOD-PCR) at another outside vendor. Audit both vendors and
monitor progress throughout the study. Audit the final report(s)
generated by these vendors and incorporate findings into the
appropriate regulatory documents required for an Investigational
New Drug (IND) filing.
g. Develop a PCR based assay for the characterization and identity
testing of the rAAV vectors expressing Clade B antigens, to be
used for analysis in the research, pre-clinical, process
development, and GMP manufacturing activities.
4. Perform specific work related to GMP (Good Manufacturing Practices, as
defined in the US Code of Federal Regulations - 21 CFR Section 211)
manufacturing of the vaccine candidate(s) as follows:
a. Transfer the Ad-hybrid production process document for both rAAV1
and rAAV2 vectors from process development to the GMP
manufacturing group and facility as described on page 32 of The
Technical Proposal.
b. Prepare and characterize Master and Working cell banks for the
packaging cell lines to be used in GMP manufacture of the rAAV1
and rAAV2 Clade B antigen expressing vectors as described on
pages 49-51 of The Technical Proposal.
c. Manufacture, characterize, test and release Adenovirus 5 (Ad5)
Master and Working viral seeds which are critical raw materials
to be used in the rAAVI, and rAAV2 manufacturing processes as
described on pages 51-52 of The Technical Proposal.
Page 2
ATTACHMENT A
STATEMENT OF WORK
TARGETED GENETICS CORPORATION
d. Manufacture, characterize, test and release Ad-Hybrid Master and
Working viral seeds which are critical raw materials for
production of both AAV1 and AAV2 Clade B antigen expressing
vectors as described on pages 51 and 52 of The Technical
Proposal.
e. Provide cell bank materials from Master and Working Cell Banks,
as well as viral seed materials to appropriate outside vendors
for characterization analyses not performed in house at TGC.
Monitor progress, and incorporate reports into appropriate GMP
manufacturing and IND documentation.
f. Provide cell materials from packaging cell lines for both AAV1
and AAV2 vectors to outside vendor for tumorigenicity testing, as
described on pages 61-62 of The Technical Proposal. Monitor
progress, and incorporate reports into appropriate GMP
manufacturing and IND documentation.
g. Conduct GMP Manufacturing to generate sufficient supply of rAAV
HIV Clade B antigen expressing vaccine product adequate for all
release testing, stability analysis, and proposed Phase I
clinical trial design. Monitor progress from all outside vendors
conducting release testing related assays and incorporate all
reports into appropriate GMP manufacturing and IND documentation.
GMP Manufacturing, characterization, and release testing to be
carried out as described on pages 51-58 and 63-68 of The
Technical Proposal.
h. Carry out product fill validation, prepare final filled product
and release of final filled product to be used in a Phase I
Clinical trial.
i. Provide GMP materials for any and all AAV1 and AAV2 Clade B
antigen expressing vectors to outside vendor for Safety/Local
Tolerability testing, as described on pages 69-72 of The
Technical Proposal. Monitor progress, and incorporate reports
into appropriate IND documentation.
5. Perform specific work related to obtaining Regulatory approvals for
and initiation of a Phase I clinical trial as follows:
a. Provide all documentation, materials, and expertise in developing
a concept sheet for submission to the HIV Vaccine Trials Network
(HVTN).
b. In conjunction with CCRI, CHOP, and the HVTN develop a protocol
for a Phase I trial of the vaccine candidates.
c. In conjunction with CCRI, CHOP, and the HVTN have a pre-IND
(Investigational New Drug) meeting with the FDA (United States
Food
Page 3
ATTACHMENT A
STATEMENT OF WORK
TARGETED GENETICS CORPORATION
and Drug Administration), and thereafter prepare regulatory
materials including a CMC document for submission of an IND
application to the FDA.
d. Provide all necessary documentation, expertise, and clinical
trial site initiation support for the initiation of a Phase I
clinical trial of the vaccine candidates.
e. In conjunction with CCRI, CHOP, and the HVTN analyze all data
generated by the Phase I clinical trial in preparation for a
Phase II clinical trial.
6. Perform specific work related to obtaining Regulatory approvals for
and initiation of a Phase II clinical trial as follows:
a. Provide all documentation, materials, and expertise in developing
a concept sheet for submission to the HIV Vaccine Trials Network
(HVTN).
b. In conjunction with CCRI, CHOP, and the HVTN develop a protocol
for a Phase II trial of the vaccine candidates.
c. In conjunction with CCRI, CHOP, and the HVTN have a pre-IND
meeting with the FDA (United States Food and Drug
Administration), and thereafter prepare regulatory materials
including a CMC document for submission of an IND application to
the FDA.
d. Provide all necessary documentation, expertise, and clinical
trial site initiation support for the initiation of a Phase II
clinical trial of the vaccine candidates.
7. Perform specific work related to development of an Alternative Cell
Substrate for the GMP manufacturing of the vaccine candidate(s) as
follows:
a. Transfer technology from CCRI and CHOP pertaining to the use of
an alternative cell substrate for the production of rAAV vectors
as described on pages 35-38 of The Technical Proposal.
b. Develop a scalable GMP compliant process for the generation of
rAAV vectors from an alternative cell substrate, through
generation and characterization of appropriate raw materials,
banking of master and working cells as described on pages 48-62
of The Technical Proposal.
c. Provide cell materials from the alternative cell substrate
packaging cell lines for both AAV1 and AAV2 vectors to outside
vendor for tumorigenicity testing, as described on pages 61-62 of
The Technical
Page 4
ATTACHMENT A
STATEMENT OF WORK
TARGETED GENETICS CORPORATION
Proposal. Monitor progress, and incorporate reports into appropriate
GMP manufacturing and IND documentation.
8. Report progress according to Reporting Requirements (refer to the
"Reporting Requirements and Deliverables" in this contract).
9. Meet with the Project Officer and the External Advisory Committee
associated with this contract.
a. The Primary Contractor (CCRI), CHOP, TGC and the NIH, after
contract award, shall jointly establish an External Advisory
Committee for the contract. In conjunction with key personnel
from CCRI and CHOP, the subcontractor's (TGC) key personnel shall
meet with the Project Officer and the Team's External Advisory
Committee at periodic intervals to be scheduled after contract
award to review progress and anticipated or existing problems.
b. In the middle (6 month mark) of each contract year, the
Sub-Contractor shall take part in a site visit review for NIAID
contract and program staff, and their External Advisory
Committee. The Sub-Contractor's Principal Investigator and all
pertinent staff shall attend this meeting. The Co-Investigator
and/or other pertinent staff shall present an update and summary
of results generated on each sub-project. These presentations
shall include summaries of all goals or milestones reached during
the review period and a description of all problems encountered
that will impact on the achievement of particular goals and
milestones pertaining to the Sub-Contractor's work as outlined in
the Contractor's research plan. The Sub-Contractor's Principal
Investigator, and pertinent 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.
Page 5
SUMMARY OF PROPOSED COSTS Attachment B
TARGETED GENETICS CORPORATION
RFP #: NIH-NIAID-DAIDS-04-42
PERIOD I PERIOD II PERIOD III PERIOD IV PERIOD V
8/31/2005 8/31/2006 8/31/2007 8/30/2008 8/31/2009
Through Through Through Through Through
***Period (dates) 8/30/2006 8/30/2007 8/29/2008 8/30/2009 8/30/2010 TOTAL
---------- --------- ---------- --------- --------- -----------
DIRECT LABOR - PERCENT OF EFFORT [*] [*] [*] [*] [*] [*]
FRINGE BENEFITS - PERCENT OF EFFORT [*] [*] [*] [*] [*] [*]
DIRECT LABOR - HOURLY [*] [*] [*] [*] [*] [*]
FRINGE BENEFITS - HOURLY [*] [*] [*] [*] [*] [*]
TOTAL DIRECT LABOR & FRINGE BENEFITS [*] [*] [*] [*] [*] [*]
*OVERHEAD [*] [*] [*] [*] [*] [*]
MATERIAL AND SUPPLIES [*] [*] [*] [*] [*] [*]
PROFESSIONAL TRAVEL [*] [*] [*] [*] [*] [*]
EQUIPMENT [*] [*] [*] [*] [*] [*]
CONSULTANTS [*] [*] [*] [*] [*] [*]
OTHER DIRECT COSTS - SUITE USAGE [*] [*] [*] [*] [*] [*]
PATIENT CARE COSTS [*] [*] [*] [*] [*] [*]
SUBCONTRACTORS [*] [*] [*] [*] [*] [*]
TOTAL OTHER DIRECT COSTS [*] [*] [*] [*] [*] [*]
SUBTOTAL: DIRECT LABOR, FRINGE [*] [*] [*] [*] [*] [*]
BENEFITS, OVERHEAD, & OTHER DIRECTS
*EXCLUSIONS(S) FROM BASE FOR G&A [*] [*] [*] [*] [*] [*]
*ADJUSTED BASE FOR G&A [*] [*] [*] [*] [*] [*]
*G&A [*] [*] [*] [*] [*] [*]
TOTAL PROPOSED COST EXCLUDING FEE [*] [*] [*] [*] [*] [*]
PROPOSED FEE/PROFIT [*] [*] [*] [*] [*] [*]
---------- -----------
TOTAL PROPOSED COST PLUS FEE/PROFIT $3,087,023 [*] [*] [*] [*] $18,243,919
========== ===========
* NOT ALL ORGANIZATIONS ALLOCATE INDIRECT COST IN THE SAME WAY. IT IS
IMPORTANT THAT YOU USE THE INDIRECT RATE STRUCTURE APPLICABLE TO YOUR
ORGANIZATION. FOR EXAMPLE, IF YOU HAVE A THREE TIER INDIRECT RATE
STRUCTURE, THEN YOU WILL USE A THREE TIER STRUCTURE WHEN PROPOSING INDIRECT
COSTS.
GENERALLY, UNIVERSITIES AND NON-PROFIT HAVE FRINGE BENEFIT AND G&A (OR
SOMETIMES CALLED F&A) RATES, WHILE FOR-PROFIT COMPANIES CAN HAVE VARIOUS
INDIRECT RATES SUCH AS FRINGE BENEFITS, OVERHEAD, G&A, ETC.
THE BASE FOR OVERHEAD COSTS INCLUDES DIRECT LABOR AND FRINGE BENEFITS.
PLEASE MODIFY IF YOUR BASE IS DIFFERENT.
IF APPLICABLE, INSERT EXCLUSIONS TO THE G&A BASE IN ROW 26.
** PLEASE INSERT THE COMPANY'S NAME AND THE RFP #.
*** ENTER THE CONTRACT START DATE IN CELL C5 AND MAKE ADJUSTMENTS FOR LEAP
YEAR.
[*] CONFIDENTIAL TREATMENT REQUESTED.
ATTACHMENT C
Subcontractee Name ______________________ Invoice
Subcontractee Address ___________________ No. 97 _____________________________
_________________________________________ ____________________________________
Subcontractee City, State, Zip Date Voucher Prepared
_________________________________________ ____________________________________
Institution Reference Number
____________________________________
Total Budget
Phone: xxx-xxx-xxx
This invoice request represents reimbursable costs from
xx/xx/xx through xx/xx/xx
Cumulative Amt.
Amount Billed From Inception
Direct Costs For Current Period Date of Billing
- ------------ ------------------ ---------------
0.00 0.00
Direct Labor 0.00 0.00
Fringe Benefits 0.00 0.00
Materials and Supplies 0.00 0.00
Consultant Fees 0.00 0.00
Patient Care 0.00 0.00
Travel-Domestic 0.00 0.00
Travel-Foreign 0.00 0.00
Subcontract Costs 0.00 0.00
Other 0.00 0.00
Total Direct Costs 0.00 0.00
Indirect Costs (Rate) 0.00 0.00
----- -----
Total Costs $0.00 $0.00
===== =====
"I certify that all payments are for the appropriate purposes and in accordance
with the subcontract."
- -------------------------------------- ---------------------------------------
Name of Official (Title)
CHOP REFERENCE NO. 22852 -01-01
ATTACHMENT D
Flowdown from subcontract between Children's Research Institute ("CRI") to The
Children's Hospital of Philadelphia ("CHOP"), dated (2/3/06) and further from
CHOP to Targeted Genetics Corporation ("TGC"), dated (2/10/06).
PATENT RIGHTS AGREEMENT
This Agreement between CHOP, a not-for-profit corporation having a principal
place of business at 3615 Civic Center Boulevard, Philadelphia, PA 19104,
Children's Hospital, Inc., a not for profit corporation and having a principal
place of business at 700 Children's Drive, Columbus, Ohio 43205, its subsidiary,
CRI, and Targeted Genetics Corporation, a private corporation having a principal
place of business at 1100 Olive Way; Suite 100, Seattle, WA 98101, is entered
into on the _10_ day of February ____, 2006 ("Effective Date") for the purpose
of allocating between the Parties certain rights relating to the cooperative
effort being proposed to the National Institutes of Health in response to
Request for Proposal NIH-NIAID-DAIDS-04-42 entitled "HIV Vaccine Design and
Development Teams" (HVDDT), to be carried out by CRI, CHOP and TGC (hereinafter
with CHI referred to as the "Parties") if funding is awarded by the National
Institutes of Health (NIH) to CRI via subcontract to fund the Proposal ("HVDDT
Project").
1. APPLICABILITY OF THIS AGREEMENT.
(a) This Agreement shall be applicable only to matters relating to the
HVDDT Project referred to in the preamble above.
(b) If a funding agreement for a HVDDT Project is awarded to CHOP based
upon the HVDDT proposal referred to in the preamble above, CRI will
make a sub-award to CHOP, CHOP will make a sub-sub-award to TGC in
accordance with the funding agreement, the HVDDT Project, and this
Agreement. If the terms of such funding agreement appear to be
inconsistent with the provisions of this Agreement, the Parties will
attempt in good faith to resolve any such inconsistencies. However, if
such resolution is not achieved within a reasonable period, neither
CRI nor CHOP shall not be obligated to subaward, nor TGC to accept the
subaward, as the case may be. If a subaward is made by CRI to CHOP and
further subawarded and accepted by TGC, this Agreement shall not be
applicable to contradict the terms of such subaward or of the funding
agreement awarded by the NIH to CRI via Subcontract, but shall be
considered to resolve ambiguities in the terms of the subaward. In no
event shall any Party be deemed to have breached the terms of this
Agreement in the event its actions or inactions are necessary to
comply with the HVDDT Project.
(c) The responsibilities of the Parties in this Agreement shall not be
delegated to any and all consultants, subcontractors, independent
contractors, or other individuals employed by CHI, CHOP or TGC for the
purposes of performing under this HVDDT Project without the written
permission of CRI.
CHOP REFERENCE NO. 22852 -01-01
2. BACKGROUND INTELLECTUAL PROPERTY.
The Parties possess rights in intellectual property not otherwise subject
to this Agreement and in existence prior to the Effective Date, which would
be useful or essential to the practice or commercialization of the results
of the research performed pursuant to the terms of the HVDDT Project under
this Agreement ("Background Intellectual Property"). Where the Parties
determine that Background Intellectual Property exists, the Parties agree
that unless contractually prohibited, they shall negotiate in good faith to
license these Background Intellectual Property rights as necessary to
practice and commercialize the Subject Inventions. The Parties acknowledge
that some existing intellectual property of CHI is already the subject of
an exclusive license for commercial purposes to TGC and that such
intellectual property may constitute Background Intellectual Property of
CHI hereunder.
3. PROJECT INTELLECTUAL PROPERTY.
(a) "Project Intellectual Property" means the legal rights in and to
inventions (including Subject Inventions as defined in 37 CFR 401 and
35 U.S.C., Section 201), patent applications, patents, copyrights,
trademarks, mask works, trade secrets, and any other legally
protestable information, including computer software, conceived or
created during the performance of the HVDDT Project.
(b) The rights of the Parties to Subject Inventions made by their
employees in the performance of this HVDDT Agreement shall be as set
forth in 35 U.S.C., Section 200 et al. and 37 CFR Part 400 et al. The
Parties agree to incorporate those provisions into this Agreement.
Unless otherwise agreed in writing, Project Intellectual Property
shall be owned by the Party whose employees conceive of the Project
Intellectual Property. Project Intellectual Property that is jointly
conceived shall be jointly owned by the Parties unless otherwise
agreed in writing ("Joint Intellectual Property"). The Parties agree
to negotiate in good faith to determine which Party shall have the
first option to file and prosecute patent applications on Joint
Intellectual Property, however the Parties agree that the Party
responsible for filing and prosecuting Joint Intellectual Property
will copy the others on all correspondence and seek the input of the
Parties on all matters related to the Joint Intellectual Property. The
Parties agree to promptly execute or require its employees (whether or
not such employees are currently employed by the Parties) to so
execute and deliver to the Party responsible for filing and
prosecuting Joint Intellectual Property or its legal representative
any and all papers, instruments or affidavits requested to prepare,
file and prosecute such joint Project Intellectual Property. TGC shall
reimburse CHOP or CHI for the costs of such preparation, filing and
prosecution during the Option Period (defined below).
Subject to the rights of the U.S. Government arising from its
sponsorship of the HVDDT Project:
CHOP REFERENCE NO. 22852 -01-01
(1) CHI and CHOP grant to TGC an exclusive option under the CHI
and CHOP Project Intellectual Property and the Joint Intellectual
Property of CHI and CHOP on terms that are commercially
reasonable at the time of the exercise of the option. TGC shall
have ninety (90) days following disclosure of Project
Intellectual Property or Joint Intellectual Property ("Option
Period") to exercise its option. In the event TGC declines to so
exercise its option during the Option Period, CHI and CHOP shall
have no further obligation to TGC regarding such rights.
(2) TGC hereby grants to CHI and CHOP a non-exclusive fully
paid-up sublicenseable license under the TGC Project Intellectual
Property for research and educational purposes.
(3) In the event TGC does not exercise its option as provided in
(1) above:
(i) Any expenses or liabilities, including patent expenses, resulting
from the practice, licensing, or exploitation of Joint
Intellectual Property shall be allocated between the Parties, as
appropriate, and shall be determined by good faith negotiations.
(ii) Any revenues and profits resulting from the practice, licensing,
or exploitation of such Joint Project Intellectual Property shall
be allocated between the Parties, as appropriate, as determined
by good faith negotiations, and shall take into account the
relative contributions of each collaborator in the conception and
reduction to practice of the Joint Project Intellectual Property
which generated said revenues.
(4) If any Party opts to not practice or license its Project
Intellectual Property and Joint Project Intellectual Property for
purposes of commercialization, the Parties agree to negotiate in
good faith to license the Party(ies) who is commercializing,
directly or through license, the Project Intellectual Property
and Joint Intellectual Property.
(c) The Parties agree to disclose to each other, in writing and in
confidence, each and every Subject Invention, which may be patentable
or otherwise protectable under the United States patent laws in Title
35, U.S.C. The Parties acknowledge that they will use best efforts to
disclose Subject Inventions to each other within thirty (30) days
after their respective inventor(s) first disclose the invention in
writing to the person(s) responsible for patent matters of the
disclosing Party. All written disclosures of such Subject Inventions
shall contain sufficient detail of the invention, identification of
any statutory bars, and shall be marked confidential, in accordance
with 35 U.S.C. Section 205.
(d) During the term of the HVDDT Project, each Party hereto may use
Project Intellectual Property of the other nonexclusively and without
compensation for the sole purpose of performing the activities
provided for in this HVDDT Project, including confidential inclusion
in: HVDDT project reports to the NIH and proposals to the NIH for
continued funding of this HVDDT project through additional phases.
CHOP REFERENCE NO. 22852 -01-01
(e) The Parties hereby agree to negotiate in good faith during the Option
Period such Project Intellectual Property rights issues such as the
choice of patent attorney selection and prosecution matters and
ameliorate any effect thereof that would threaten the commercial
viability of the Subject Inventions.
4. CONFIDENTIALITY/PUBLICATION.
(a) Background Intellectual Property and Project Intellectual Property of
a Party, as well as other proprietary or confidential information of a
Party, disclosed by that Party to the other in connection with this
HVDDT Project shall be received and held in confidence by the
receiving Party and, except with the consent of the disclosing Party
or as required for regulatory or statutory compliance under the HVDDT
Project and shall neither be used by the receiving Party, other than
to perform under the HVDDT Project, nor disclosed by the receiving
Party to others, provided that the receiving Party has notice that
such information is regarded by the disclosing Party as proprietary or
confidential. However, these confidentiality obligations shall not
apply to use or disclosure by the receiving Party after such
information is or becomes known to the public without breach of this
Agreement or is or becomes known to the receiving Party from a third
party lawfully entitled to disclose, as evidenced by receiving Party's
written records, or is developed by or for the receiving Party
independently of its knowledge of or access to the disclosing Party's
confidential information, as evidenced by receiving Party's written
records. If the receiving Party is required by law to disclose any of
the Background Intellectual Property or Project Intellectual Property,
the receiving party shall notify disclosing party promptly and
reasonably assist the disclosing Party to obtain a protective order or
other remedy of disclosing Party's election. The receiving Party shall
furnish only that portion of the information that is legally required,
exercise reasonable efforts to obtain reliable assurance that the
information shall be held in confidence and allow disclosing Party
prior review of such disclosure.
(b) Subject to the terms of paragraph (a) above, any Party may publish its
results from this HVDDT Project. However, the publishing Party shall
provide the other Parties a thirty-day period in which to review
proposed publications, identify proprietary or confidential
information, and submit comments. The publishing Party shall not
publish or otherwise disclose proprietary or confidential information
identified and owned by another Party and the publishing Party will
give full consideration to all comments before publication.
Furthermore, upon request of the reviewing Party, publication will be
deferred for up to sixty additional days for preparation and filing of
a patent application. Following such deferred period, each Party has
the right to make publicly available the results of the research
funded by the HVDDT Project, in accordance with scientific custom.
CHOP REFERENCE NO. 22852 -01-01
5. LIABILITY.
(a) EACH PARTY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES RUNNING TO THE
OTHER OR THROUGH THE OTHER TO THIRD PARTIES, WHETHER EXPRESS,
STATUTORY OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND FREEDOM FROM
INFRINGEMENT. NO PARTY SHALL BE LIABLE FOR LOSS OF USE, LOSS OF
PROFITS OR ANY OTHER CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES.
(b) Each Party ("Indemnitor") shall indemnify, defend and hold harmless
the other Parties and their respective affiliates, officers,
directors, boards, trustees, employees, agents and consultants
("Indemnitee") with regard to any claims, losses damages, and/or
liability of whatsoever kind or nature, as well as all costs and
expenses, including, reasonable attorneys' fees and court costs
(collectively "Loss") arising now or in the future from any action or
inaction by Indemnitor, including a breach of this Agreement or any
other agreement related to the HVDDT Project, and/or any negligent or
malfeasant act or omission by the Indemnitor, its consultants,
subcontractors, independent contractors or other individuals employed
Indemnitor, except to the extent such Loss is attributable to an
indemnification obligation of an Indemnitee hereunder.
6. TERMINATION.
(a) This Agreement shall terminate immediately upon the completion of the
HVDDT Project or in the event no funding is received from the NIH
thereunder. This Agreement may also be terminated by any Party in the
event of an uncured breach by another Party following thirty days'
written notice of such breach; provided that if any other agreement
related to the HVDDT Project is still in effect, this Agreement shall
survive for the benefit of the non-breaching Party(ies).
(b) The termination or expiration of this Agreement shall not affect the
rights and obligations of the Parties accruing prior thereto,
including its share of any uncancelable commitments as of the
termination date. The confidentiality, use, and/or non-disclosure
obligations of this Agreement shall survive any termination of this
Agreement, until the information falls within one of the exceptions in
4(a).
7. MISCELLANEOUS PROVISIONS.
(a) Entire Agreement. This Agreement constitutes the entire agreement
between the three Parties with respect to the subject matter of the
HVDDT Project and supersedes all prior communications, agreements or
understandings, written, electronic or oral. No modification,
amendment, or waiver of this Agreement, or any of its provisions,
shall be effective unless executed by all Parties in
CHOP REFERENCE NO. 22852 -01-01
writing. Each Party acknowledges that, in entering into this
Agreement, it did not rely on any representation, warranty or other
assurance from the other Party except as expressly provided herein.
Notwithstanding the foregoing, nothing in this Agreement shall affect
the liability of either Party for any fraudulent misrepresentation.
Each Party acknowledges that it was provided an opportunity to seek
advice of counsel and as such this Agreement shall not be strictly
construed for or against either Party.
(b) Severability. The provisions of this Agreement are severable, and in
the event that any provision of this Agreement is determined to be
invalid or unenforceable under any controlling body of law, such
invalidity or non-enforceability shall not in any way affect the
validity or enforceability of the remaining provisions.
(c) Assignment. Either Party may assign or otherwise transfer this
Agreement only to the assignee or transferee of its entire business or
of that part of its business to which this Agreement relates. Any
assignment or transfer in contravention with this section shall be
null and void. This Agreement shall be binding on and inure to the
sole benefit of the Parties and their permitted successors and
assigns.
(d) Use of Names. No Party shall use the names or trademarks of the other
nor any adaptation thereof without prior written consent obtained from
the other in each separate case, except that the Parties may state the
existence of the HVDDT Project and their roles thereunder, and shall
be free to list name of party as required for publication in
peer-reviewed journals, and as requested for grant applications.
(e) Non-waiver. The delay or failure of either Party to assert a right
hereunder or to insist upon compliance with any term or condition of
this Agreement shall not constitute a waiver of that right or excuse a
similar subsequent failure to perform any such term or condition by
the other Party. A valid waiver must be executed in writing and signed
by the Party granting such waiver.
(f) Attorney Fee Recovery. In any litigation arising under or relating to
this Agreement, the prevailing Party shall be entitled to recover
reasonable attorney's fees and litigation costs.
(g) No Third Party Benefit. This Agreement is for the sole benefit of the
Parties and their permitted successors and assigns and shall not be
construed as conferring any rights to any third party.
(h) Independent Contractors. Nothing contained in this Agreement shall
place the Parties in a partnership, joint venture or agency
relationship and neither Party shall have the right or authority to
obligate or bind the other Party in any manner.
CHOP REFERENCE NO. 22852 -01-01
(i) Executed in Counterparts. This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original but all
of which taken together constitute one and the same instrument.
The Parties have hereunto set their hands and seals and duly execute this
Agreement as of the Effective Date.
AGREED TO AND ACCEPTED:
TARGETED GENETICS CORPORATION
BY: /s/ Barrie Carter DATE: 2/13/06
----------------------------------
PRINT NAME: Barry Carter
TITLE: Chief Scientific Officer
CHILDREN'S HOSPITAL OF PHILADELPHIA
BY: /s/ Sara Dubberly DATE: 2/10/06
---------------------------------
PRINT NAME: Sara Dubberly
TITLE: Director, Sponsored Programs