Exhibit 10.38

 

PharmAthene, Inc.

Confidential Materials Omitted and Submitted Separately to the

Securities and Exchange Commission

Confidential Portions denoted by [***]

 

Document          
Control #A00821

 

OMB Approval 2700-0042  

 

AWARD/CONTRACT

1.  THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350)

[g275831ma01i001.jpg]

RATING

N/A

PAGE    OF   PAGES

       1

    59

 

 

 

2   CONTRACT (Proc Inst Ident) NO

HHSN272200800049C

3.  EFFECTIVE DATE

September 25, 2008

4.  REQUISITION/PURCHASE REQUEST/PROJECT NO.

             751380

 

 

 

 

 

5   ISSUED BY         CODE

 

6.  ADMINISTERED BY (If other than Item 6)

CODE

N/A

National Institutes of Health
National Institute of Allergy and Infectious Diseases
DEA, Office of Acquisitions
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, Maryland 20892-7612

MIDRCB-B

BAA-NIH-BARDA-NIAID-DMID-AI2007007

NIAID Reference No. N01-AI-80049

 

 

 

7   NAME AND ADDRESS OF CONTRACTOR (No street, county, state and ZIP Code)

PharmAthene, Inc.                          VIN:  1123607
One Park Place, Suite 450
Annapolis, MD   21401

8.  DELIVERY

9.  DISCOUNT FOR PROMPT PAYMENT

N/A

 

10. SUBMIT INVOICES

ITEM

 

 

 

 

CODE

FACILITY CODE

ADDRESS SHOWN IN:

Art. G.3.

 

 

 

 

 

 

11. SHIP TO/MARK FOR

CODE

N/A

12. PAYMENT WILL BE MADE BY

CODE

N/A

 

 

 

 

Article F.2.

See Article G.3.

 

 

13. AUTHORITY FOR USING OTHER FULL AND OPEN  
 COMPETITION:

14. ACCOUNTING AND APPROPRIATION DATA
 TIN:  04-3560100               SOCC 25.55
 CAN:  8-8470038               Amount:  $10,000,000

o 10 U.S.C. 2304(c)( )

o 41 U.S.C. 253(c)( )

 

 

 

 

15A  ITEM NO.

15B.  SUPPLIES/SERVICES

15C.  QUANTITY

15D.  UNIT

15E.  UNIT PRICE

15F.  AMOUNT

 

 

 

 

 

Title:  Biodefense Vaccine Enhancement - Development of a Third
Generation rPA Anthrax Vaccine

Period:  September 25, 2008 - September 24, 2011

Contract Type:  Cost-Plus-Fixed-Fee - Completion

Year 1
Year 2
Year 3

$4,572,783
$5,090,714
$3,544,751

 

 

 

15G.  TOTAL AMOUNT OF CONTRACT

[g275831ma01i001.jpg]

$13,208,248

 

16.  TABLE OF CONTENTS

 

 

 

 

 

 

 

 

(ü)

SEC

DESCRIPTION

PAGE(S)

(ü)

SEC

DESCRIPTION

PAGE(S)

PART I - THE SCHEDULE

PART II – CONTRACT CLAUSES

x

A

SOLICITATION/CONTRACT FORM

1

x

I

CONTRACT CLAUSES

48

x

B

SUPPLIES OR SERVICES AND PRICE/COST

4

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

 

x

C

DESCRIPTION/SPECS./WORK STATEMENT

16

x

J

LIST OF ATTACHMENTS

58

x

D

PACKAGING AND MARKING

23

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

x

E

INSPECTION AND ACCEPTANCE

23

x

K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

59

x

F

DELIVERIES OR PERFORMANCE

24

x

G

CONTRACT ADMINISTRATION DATA

32

o

L

INSTRS., CONDS., AND NOTICES TO OFFERORS

 

x

H

SPECIAL CONTRACT REQUIREMENTS

36

o

M

EVALUATION FACTORS FOR AWARD

 

 

CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

 

 

17.  x  CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is
required to sign this document and return     2     copies to issuing office)
Contractor agrees to furnish and deliver all items or perform all the services
set forth or otherwise identified above and on any continuation sheets for the
consideration stated herein.  The rights and obligations of the parties to this
contract shall be subject to and governed by the following documents:  (a)
this award/contract, (b) the solicitation, if any, and (c) such provisions,
representations, certifications, and specifications, as are attached or
incorporated by reference herein.  (Attachments are listed herein)

18.  o  AWARD (Contractor is not required to sign this document) Your
offer on Solicitation Number
                                                                .
including the additions or changes made by you which additions or changes are
set forth in full above, is hereby accepted as to the items listed above and on
any
continuation sheets.  This award consummates the contract which consists of the
following documents:  (a) the Government’s solicitation and your offer, and (b)
this award/contract.  No further contractual document is necessary.

 

 

19A.  NAME AND TITLE OF SIGNER (Type or print)

20A.  NAME OF CONTRACTING OFFICER

Joseph L. O’Connor
Director of Contracts

Teresa A. Baughman
Contracting Officer, OA, DEA, NIAID, NIH, DHHS

 

 

 

 

19B.  NAME OF CONTRACTOR

19C.  DATE SIGNED

20B.  UNITED STATES OF AMERICA

20C.  DATE SIGNED

 

PharmAthene, Inc.

 

          9/25/08

 

 

 

          9/25/08

 

/s/ Joseph L. O’Connor

 

 

By

/s/ Theresa A. Baughman

 

 

 

(Signature of person authorized to sign)

 

 

 

(Signature of Contracting Office)

 

 

 

 

 

 

 

 

 

 

NSN  754001-152-8069
PREVIOUS EDITION UNUSABLE

 

26-107
Computer Generated

STANDARD FORM 26 (REV. 4-85)
Prescribed by GSA
FAR (48 CFR) 53 214(a)

 

--------------------------------------------------------------------------------

 

Contract Number : HHSN272200800049C

Reference Number : N01-AI-80049

 

CONTRACT TABLE OF CONTENTS

 

PART I - THE SCHEDULE

 

4

SECTION A - SOLICITATION/CONTRACT FORM

 

4

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

 

4

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

4

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

 

4

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

 

9

ARTICLE B.4. ADVANCE UNDERSTANDINGS

 

11

 

 

 

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

16

ARTICLE C.1. STATEMENT OF WORK

 

16

ARTICLE C.2. REPORTING REQUIREMENTS

 

16

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

 

22

 

 

 

SECTION D - PACKAGING, MARKING AND SHIPPING

 

23

SECTION E - INSPECTION AND ACCEPTANCE

 

23

 

 

 

SECTION F - DELIVERIES OR PERFORMANCE

 

24

ARTICLE F.1. PERIOD OF PERFORMANCE

 

24

ARTICLE F.2. DELIVERIES

 

24

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

 

31

 

 

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

32

ARTICLE G.1. PROJECT OFFICER

 

32

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.270-5 (January 2006)

 

32

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT

 

33

ARTICLE G.4. INDIRECT COST RATES

 

34

ARTICLE G.5. GOVERNMENT PROPERTY

 

35

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

35

 

 

 

SECTION H - SPECIAL CONTRACT REQUIREMENTS

 

36

ARTICLE H.1. HUMAN SUBJECTS

 

36

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

 

36

ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

 

36

ARTICLE H.4. REGISTRATION OF CLINICAL TRIALS IN THE GOVERNMENT DATABASE
(ClinicalTrials.gov)

 

37

ARTICLE H.5. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

 

37

ARTICLE H.6. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene
Transfer Research)

 

37

ARTICLE H.7. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

 

38

ARTICLE H.8. NEEDLE EXCHANGE

 

38

ARTICLE H.9. PRESS RELEASES

 

38

ARTICLE H.10. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC
INFORMATION

 

38

ARTICLE H.11. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

 

38

ARTICLE H.12. RESTRICTION ON ABORTIONS

 

38

 

2

--------------------------------------------------------------------------------

 

ARTICLE H.13. SALARY RATE LIMITATION LEGISLATION PROVISIONS

 

38

ARTICLE H.14. PRIVACY ACT, HHSAR 352.270-11 (January 2006)

 

39

ARTICLE H.15. ANIMAL WELFARE

 

39

ARTICLE H.16. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

 

40

ARTICLE H.17. OMB CLEARANCE or CLINICAL EXEMPTION

 

40

ARTICLE H.18. OPTION PROVISION

 

40

ARTICLE H.19. INFORMATION SECURITY

 

40

ARTICLE H.20. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY (January 2008)

 

43

ARTICLE H.21. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF
INVESTIGATORS

 

44

ARTICLE H.22. PUBLICATION AND PUBLICITY

 

45

ARTICLE H.23. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

 

45

ARTICLE H.24. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

 

45

ARTICLE H.25. SHARING RESEARCH DATA

 

46

ARTICLE H.26. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

 

46

ARTICLE H.27. POSSESSION, USE OR TRANSFER OF A HIGHLY PATHOGENIC AGENT

 

47

ARTICLE H.28. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

 

47

ARTICLE H.29. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

 

47

ARTICLE H.30. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS
RESULTING FROM NIH-FUNDED RESEARCH

 

47

 

 

 

PART II - CONTRACT CLAUSES

 

48

SECTION I - CONTRACT CLAUSES

 

48

 

 

 

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

58

SECTION J - LIST OF ATTACHMENTS

 

58

 

 

 

1. Statement of Work

 

58

2. Invoice/Financing Request and Contract Financial Reporting Instructions for
NIH Cost-Reimbursement Type Contracts, NIH(RC)-4

 

58

3. Inclusion Enrollment Report

 

58

4. Annual Technical Progress Report Format for Each Study

 

58

5. Safety and Health

 

58

6. Procurement of Certain Equipment

 

58

7. Research Patient Care Costs

 

58

8. Disclosure of Lobbying Activities, SF-LLL

 

58

9. Commitment To Protect Non-Public Information

 

58

10. Roster of Employees Requiring Suitability Investigations

 

58

11. Employee Separation Checklist

 

58

 

 

 

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

59

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

 

59

1.   Annual Representations and Certifications

 

59

2.   Representations and Certifications

 

59

3.   Human Subjects Assurance Identification Number

 

59

4.   Animal Welfare Assurance Number

 

59

 

3

--------------------------------------------------------------------------------

 

PART I - THE SCHEDULE

 

SECTION A - SOLICITATION/CONTRACT FORM

 

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE B.1.  BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

This contract will support the development of an anthrax vaccine containing rPA
and CpG immunostimulant.  The work will demonstrate the following:  stability of
the candidate vaccine and diluent at 35 degrees C over the duration of the base
period; safety prior to human use through acute dose and repeat dose toxicology
testing in two (2) animal species; improved vaccine efficacy over existing
vaccines through non-clinical aerosol challenge studies in the pre-existing
rabbit and macaque models, plus supporting studies in the mouse models; and
safety and immunogenicity of the vaccine in humans through a Phase I dose
escalation clinical trial.  The option exists for the scale-up and validation at
200,000 doses/lot, along with a Phase II clinical trial.

 

ARTICLE B.2.  ESTIMATED COST AND FIXED FEE

 

a.               The estimated cost of the Base Period of this contract is $ [*
* *]

 

b.              The fixed fee for the Base Period of this contract is $ [* * *]
Payment shall be subject to the withholding provisions of the clauses ALLOWABLE
COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in
Part II, ARTICLE I.1. of this contract.  Payment of fixed fee shall not be made
in less than monthly increments.

 

c.               The total estimated amount of the contract, represented by the
sum of the estimated cost plus the fixed fee for the Base Period is $13,208,248.

 

d.              If the Government exercises its option(s) pursuant to the OPTION
PROVISION Article in SECTION H of this contract, the Government’s total
estimated contract amount represented by the sum of the estimated cost plus the
fixed fee will be increased as follows:

 

 

 

Estimated Cost
($)

 

Fixed Fee
($)

 

Estimated Cost
Plus Fixed Fee
($)

 

Base Period - Process Devel. & Feasibility

 

[* * *]

 

[* * *]

 

$

13,208,248

 

Option 1 - Base Extension - Non-Clinical Development

 

[* * *]

 

[* * *]

 

[* * *]

 

Option 2 - Base Extension - Phase I Clinical Trial

 

[* * *]

 

[* * *]

 

[* * *]

 

Option 3 - Scale-Up and Validation

 

[* * *]

 

[* * *]

 

[* * *]

 

Option 4 - Phase II Clinical Trial

 

[* * *]

 

[* * *]

 

[* * *]

 

Total Base Period and Options

 

[* * *]

 

[* * *]

 

$

83,891,328

 

 

4

--------------------------------------------------------------------------------

 

e.               Fee Payment Schedule Based on 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

 

MILESTONE

 

MILESTONE
DESCRIPTION

 

TASK: COMPLETION OF ACTIVITY

 

ESTIMATED
COMPLETION
DATE

 

FIXED
FEE ($)

 

BASE PERIOD - Process Development and Feasibility

 

 

 

 

 

 

 

 

 

 

 

1

 

PROCESS DEVELOPMENT AND MANUFACTURING

 

[* * *]

 

Mar 2011

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

2

 

ASSAYS

 

[* * *]

 

Aug 2011

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

3

 

STABILITY

 

[* * *]

 

July 2011

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

4

 

PRECLINICAL TOXICOLOGY

 

[* * *]

 

Mar 2011

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

5

 

NON CLINICAL - MODEL FEASIBILITY STUDIES (Dstl)

 

[* * *]

 

Nov 2010

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

10

 

REGULATORY

 

[* * *]

 

May 2011

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

11

 

DELIVERY OF VACCINE TO NIAID

 

[* * *]

 

Apr 2011

 

[* * *]

 

 

 

 

 

TOTAL BASE PERIOD

 

[* * *]

 

 

5

--------------------------------------------------------------------------------

 

OPTION 1 - Non-Clinical Development

 

 

 

6

 

NON CLINICAL - RABBIT GUP

 

[* * *]

 

To Be Determined (TBD)

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

7

 

NON CLINICAL NHP GUP

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

8

 

PASSIVE TRANSFER

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

TOTAL - OPTION 1

 

[* * *]

 

 

OPTION - Phase I Clinical Trial

 

 

 

9

 

CLINICAL TRIAL (PHASE 1) DOSE ESCALATION

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

TOTAL - OPTION 2

 

[* * *]

 

 

6

--------------------------------------------------------------------------------

 

OPTION 3 - Scale-Up and Validation

 

 

 

12

 

DELIVERY OF PROCESS DEVELOPMENT PLAN FOR SCALE - UP

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

13

 

FDP DEMONSTRATION AND VERIFICATION

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

14

 

TECHNOLOGY TRANSFER OF DILUENT PROCESS TO CMO

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

15

 

OPTION 1b FDP PROCESS VALIDATION

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

16

 

OPTION 1c CONSISTENCY CAMPAIGN

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

17

 

OPTION 1b DILUENT CONSISTENCY

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

18

 

DRUG PRODUCT - ANALYTICAL METHOD VALIDATION AT CRO

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

19

 

DILUENT ASSAYS - TECHNOLOGY TRANSFER AND ASSAY VALIDATION

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

20

 

IMMUNOPOTENCY ASSAY DEVELOPMENT

 

[* * *]

 

TBD

 

[* * *]

 

 

7

--------------------------------------------------------------------------------

 

OPTION 3 - Scale-Up and Validation

 

 

 

21

 

STABILITY OF FDP

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

22

 

STABILITY OF DILUENT

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

TOTAL OPTION 3

 

[* * *]

 

 

OPTION 4 - Phase II Clinical Trial

 

 

 

23

 

cGMP MANUFACTURE OF FDP CLINICAL BATCHES

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

24

 

STABILITY OF CLINICAL LOTS

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

25

 

PHASE II CLINICAL TRIAL

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

26

 

RABBIT PASSIVE TRANSFER USING HUMAN PHASE I & PHASE II SERA

 

[* * *]

 

TBD

 

[* * *]

 

 

 

 

 

 

 

 

 

 

 

TOTAL OPTION 4

 

[* * *]

 

 

8

--------------------------------------------------------------------------------

 

f.                 Total funds currently available for payment and allotted to
this contract are $10,000,000 of which [* * *] represents the estimated costs,
and of which [* * *] represents the fixed fee.  For further provisions on
funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. 
Authorized Substitutions of Clauses.

 

g.              It is estimated that the amount currently allotted will cover
performance of the contract through September 24, 2010.

 

h.              The Contracting Officer may allot additional funds to the
contract without the concurrence of the Contractor.

 

ARTICLE B.3.  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; see subparagraph
b. below

 

5.               Foreign travel - See subparagraph b. 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), regardless of
acquisition value.

 

9

--------------------------------------------------------------------------------

 

10.         Light Refreshment and Meal Expenditures

 

Requests to use contract funds to provide light refreshments and/or meals to
either federal or nonfederal employees must be submitted to the Project Officer,
with a copy to the Contracting Officer, at least six (6) weeks in advance of the
event.  The request shall contain the following information:  (a) name, date,
and location of the event at which the light refreshments and/or meals will be
provided; (b) a brief description of the purpose of the event; (c) a cost
breakdown of the estimated light refreshment and/or meal costs; (d) the number
of nonfederal and federal attendees receiving light refreshments and/or meals;
and (e) if the event will be held somewhere other than a government facility,
provide an explanation of why the event is not being held at a government
facility.

 

Refer to NIH Manual Chapter 1160-1, Entertainment, for more information on NIH’s
policy on the use of appropriated funds for light refreshments and meals.

 

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 THE FOLLOWING AMOUNTS FOR THE BASE PERIOD AND ANY
OPTION (IF EXERCISED) WITHOUT THE PRIOR WRITTEN APPROVAL OF THE CONTRACTING
OFFICER:

 

·                  Base Period:  [ * * *]

 

·                  Option 1:  [* * *]

 

·                  Option 2:  [* * *]

 

·                  Option 3:  [* * *]

 

·                  Option 4:  [* * *]

 

B.              THE CONTRACTOR SHALL INVOICE AND BE REIMBURSED FOR ALL TRAVEL
COSTS IN ACCORDANCE WITH FEDERAL ACQUISITION REGULATIONS (FAR) 31.2 - CONTRACTS
WITH COMMERCIAL ORGANIZATIONS, SUBSECTION 31.205-46, TRAVEL COSTS.

 

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.

 

10

--------------------------------------------------------------------------------

 

ARTICLE B.4.  ADVANCE UNDERSTANDINGS

 

Other provisions of this contract notwithstanding, approval of the following
items, for the base period and any option (if exercised), within the limits set
forth is hereby granted without further authorization from the Contracting
Officer.

 

a.               Subcontracts

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] an amount not to exceed as
follows:

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

11

--------------------------------------------------------------------------------

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

12

--------------------------------------------------------------------------------

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

[* * *]

 

To negotiate a subcontract with [* * *] for [* * *] for an amount not to exceed
as follows:

 

·                  [* * *]

 

·                  [* * *]

 

Award of the subcontract shall not proceed without the prior written consent of
the Contracting Officer upon review of the supporting documentation required by
FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

 

b.              Consultants [* * *]

 

13

--------------------------------------------------------------------------------

 

[* * *]

 

c.               Confidential Treatment of Sensitive Information

 

The Government has determined that the information that the Contractor will
generate, have access to, or be furnished by the Government during the
performance of the contract is of a sensitive nature.  The Contractor shall
guarantee strict confidentiality of this information.

 

Disclosure of the information, 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 under the contract, the Contractor shall obtain a
written determination from the Contracting Officer.

 

14

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d.              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. HHSN272200800049C

 

NIAID Reference No. N01-AI-80049

 

e.               Advance Copies of Press Releases

 

The Contractor agrees to accurately and factually represent the work conducted
under this contract in all press releases.  In accordance with NIH Manual
Chapter 1754, misrepresenting contract results or releasing information that is
injurious to the integrity of NIH may be construed as improper conduct.  The
complete text of NIH Manual Chapter 1754 can be found at: 
http://www1.od.nih.gov/oma/manualchapters/management/1754/

 

Press releases shall be considered to include the public release of information
to any medium, excluding peer-reviewed scientific publications.  The Contractor
shall ensure that the Project Officer has received an advance copy of any press
release related to this contract not less than seven (7) calendar days prior to
the issuance of the press release.

 

f.                 Indirect Costs

 

[* * *]

 

15

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

ARTICLE C.1.  STATEMENT OF WORK

 

a.               Independently and not as an agent of the Government, the
Contractor shall furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the Government as
needed to perform the Statement of Work, dated September 25, 2008, set forth in
SECTION J-List of Attachments, attached hereto and made a part of this contract.

 

b.              Privacy Act System of Records Number 09-25-0200 is applicable to
this contract and shall be used in any design, development, or operation work to
be performed under the resultant contract.  Disposition of records shall be in
accordance with SECTION C of the contract, and by direction of the Project
Officer(s).

 

ARTICLE C.2.  REPORTING REQUIREMENTS

 

All reports required herein shall be submitted in electronic format.  In
addition, one (1) hardcopy of each report shall be submitted to the Project
Officer and the Contracting Officer, unless otherwise specified.  The reports
included in this Article are applicable to the base period and any option (if
exercised).

 

a.               Technical Reports

 

In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports during the period of
performance of this contract:

 

[Note:  Beginning May 25, 2008, the Contractor shall include, in any technical
progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript
Submission reference number when citing publications that arise from its NIH
funded research.]

 

The Contractor shall submit to the Contracting Officer and to the Project
Officer technical progress reports covering the work accomplished during each
reporting period.  These reports are subject to technical inspection and
requests for clarification by the Project Officer.  These reports shall be brief
and factual and prepared in accordance with the format described below.

 

Format of Cover Page:  All reports shall include a cover page prepared in
accordance with the following format:

 

·                  Contract Number and Project Title

 

·                  Title of Report

 

·                  Period of Performance Being Reported

 

·                  Contractor’s Name and Address

 

·                  Author(s)

 

·                  Date of Submission

 

·                  Delivery Address

 

16

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1.               Monthly Progress Report

 

The Monthly Progress Report shall include a description of the activities during
the reporting period, and the activities planned for the ensuing reporting
period.  The first reporting period consists of the first full month of
performance plus any fractional part of the initial month.  Thereafter, the
reporting period shall consist of each calendar month.  A Monthly Progress
Report shall not be required when an Annual Progress Report or the Final Report
is due.

 

Section A - An introduction covering the purpose and scope of the contract
effort.

 

Section B - The Monthly Progress Report shall describe the results of work
performed during the reporting period for each milestone and key objective in
the approved Product Development Plan.  For each milestone, include a summary of
accomplishments in sufficient detail to explain comprehensively the results
achieved, and a summary of any technical issues/problems encountered during the
reporting period.  The description shall include pertinent data and/or graphs in
sufficient detail to explain any significant results achieved, preliminary
conclusions resulting from analysis, and scientific evaluation of data
accumulated to date under the project for each milestone.  The current status of
each milestone and sub-task shall be displayed on an updated Gantt chart as a
component of the Monthly Progress Report.  In addition, requests and approvals
to conduct human trials, and Inclusion Enrollment Report forms, when
appropriate, shall be included.  Preprints and reprints of papers, abstracts,
and slides used in oral presentations shall also be submitted with the Monthly
Progress Report.

 

Section C - Substantive performance:  Describe current technical or substantive
performance, any problems encountered, and corrective actions taken or
proposed.  Explain any differences between planned progress and actual progress,
reasons for differences that have occurred, and corrective actions taken or
proposed.  Provide a summary of work proposed for the next year period.  Submit
copies of manuscripts (published and unpublished), abstracts, and any protocols
or methods developed specifically under the contract during the reporting
period.  Include a summary of any inventions developed during the course of the
contract.  If applicable, advise the NIAID of other government-funded activities
beyond the Contractor’s control that could adversely impact performance.

 

Section D - Estimated and actual total costs incurred shall be provided for each
milestone and task performed during the reporting period.  Costs shall be
reported by a breakdown of Direct Labor, Direct Materials, Subcontracts,
Consultants, Travel, etc.

 

2.               Annual Progress Report

 

The Annual Progress Report shall include a summation of the results of the
entire contract work for the period covered.  The Annual Progress Report is due
after each anniversary date of the contract.  An Annual Progress Report will not
be required for the period when the Final Report is due.

 

Section A - An introduction covering the purpose and scope of the contract
effort.

 

Section B - Describe the results of work accomplished during the reporting
period in relation to the approved Product Development Plan and each key
objective and milestone.  For each milestone, include a summary of
accomplishments in sufficient detail to explain comprehensively the results
achieved, and a summary of technical issues/problems encountered for the
reporting period.  The description shall include pertinent data and/or graphs in
sufficient detail to explain any significant results achieved, preliminary
conclusions resulting from analysis, and scientific evaluation of data
accumulated to date under the project for each milestone.  The current status of
each milestone and sub-task shall be displayed on an updated Gantt chart as a
component of the Annual Progress Report.  In addition, requests and approvals to
conduct human trials, and Inclusion Enrollment Report forms, when appropriate,
shall be included.

 

17

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Section C - Substantive performance:  Describe current technical or substantive
performance, any problems encountered, and corrective actions taken or
proposed.  Explain any differences between planned progress and actual progress,
reasons for differences that have occurred, and corrective actions taken or
proposed.  Provide a summary of work proposed for the next year period.  Submit
copies of manuscripts (published and unpublished), abstracts, and any protocols
or methods developed specifically under the contract during the reporting
period.  Include a summary of any inventions developed during the course of the
contract.

 

Section D - Estimated and actual total costs incurred shall be provided for each
milestone and task performed during the reporting period.  Costs shall be
reported by a breakdown of Direct Labor, Direct Materials, Subcontracts,
Consultants, Travel, etc.

 

3.               Annual Technical Progress Report for Clinical Research Study
Populations

 

The Contractor shall submit information about the inclusion of women and members
of minority groups and their subpopulations for each study being performed under
this contract.  The Contractor shall submit this information in the format
indicated in the Attachment entitled, “Inclusion Enrollment Report,” which is
set forth in SECTION J of this contract.  The Contractor also shall use this
format, modified to indicate that it is a final report, for reporting purposes
in the final report.  The Contractor shall submit the report in accordance with
the DELIVERIES Article in SECTION F of this contract.

 

In addition, the NIH Policy and Guidelines on the Inclusion of Women and
Minorities as Subjects in Clinical Research, Amended, October, 2001 applies.  If
this contract is for Phase III clinical trials, see Il.B of these guidelines. 
The Guidelines may be found at the following website:

 

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

 

Include a description of the plans to conduct analyses, as appropriate, by
sex/gender and/or racial/ ethnic groups in the clinical trial protocol as
approved by the IRB, and provide a description of the progress in the conduct of
these analyses, as appropriate, in the annual progress report and the final
report.  If the analysis reveals no subset differences, a brief statement to
that effect, indicating the subsets analyzed, will suffice.  The Government
strongly encourages inclusion of the results of subset analysis in all
publication submissions.  In the final report, the Contractor shall include all
final analyses of the data on sex/gender and race/ethnicity.

 

4.               Draft Final Report

 

The Contractor shall provide the Project Officer with a copy of the Final Report
in draft form ninety (90) calendar days prior to the completion date of the
contract.  The Final Report shall contain an executive summary for activities
performed under the contract.  The format described for the Monthly Progress
Report shall be used for the Final Report.  The Project Officer will review the
Draft Final Report and provide the Contractor with comments within fifteen (15)
calendar days after receipt.  The Final Report shall be corrected by the
Contractor, if necessary.

 

5.               Final Report

 

The Final Report shall include a summation of the work performed and results
obtained for the entire contract period of performance.  This report shall be in
sufficient detail to describe comprehensively the methods used and the results
achieved, shall use the format for the Monthly Progress Report, and shall also
contain an executive summary for activities performed under the contract. 
Preprints and reprints not submitted previously shall be submitted as an
appendix.  The Final Report shall be submitted in accordance with the DELIVERIES
Article in SECTION F of the contract.

 

18

--------------------------------------------------------------------------------

 

6.               Summary of Salient Results

 

The Contractor shall submit, with the Final Report, a summary (not to exceed 200
words) of salient results achieved during the performance of the contract.

 

7.               Report on Select Agents or Toxins and/or Highly Pathogenic
Agents

 

For work involving the possession, use, or transfer of a Select Agent or Toxin
and/or a Highly Pathogenic Agent, the following information shall also be
included in each Annual Progress Report:

 

1.               Any changes in the use of the Select Agent or Toxin and/or a
Highly Pathogenic Agent, that have resulted in a change in the required
biocontainment level, and any resultant change in location, if applicable, as
determined by the IBC or equivalent body or institutional biosafety official.

 

2.               If work with a new or additional Select Agent or Toxin and/or a
Highly Pathogenic Agent will be conducted in the upcoming reporting period,
provide:

 

a.               A list of each new or additional Select Agent or Toxin and/or a
Highly Pathogenic Agent that will be studied;

 

b.              A description of the work that will be done with each new or
additional Select Agent or Toxin and/or a Highly Pathogenic Agent;

 

c.               The title and location for each biocontainment
resource/facility, including the name of the organization that operates the
facility, and the biocontainment level at which the work will be conducted, with
documentation of approval by your IBC or equivalent body or institutional
biosafety official.  It must be noted if the work is being done in a new
location.

 

If the IBC or equivalent body or institutional biosafety official has
determined, for example, by conducting a risk assessment, that the work that has
been performed or is planned to be performed under this contract may be
conducted at a biocontainment safety level that is lower than BSL3, a statement
to that affect shall be included in each Annual Progress Report.

 

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent
has been performed or is planned to be performed under this contract, a
statement to that affect shall be included in each Annual Progress Report.

 

b.              Other Reports/Deliverables

 

In addition to the above reports, the following are considered other reports and
deliverables under this contract and are identified in the Statement of Work.  A
listing is included in the DELIVERIES Article in SECTION F.

 

1.               Product Development Plan

 

Within thirty (30) calendar days after the effective date of the contract and
prior to initiation of product development activities, the Contractor shall
submit to the Project Officer and Contracting Officer an updated Product
Development Plan to accomplish the product development activities detailed in
the negotiated Statement of Work for the base period of performance, plus
Options 1 and 2 (if exercised).  This Plan shall be updated following any
milestone change or deviation.

 

Within sixty (60) calendar days after the exercise of Option 3, the Contractor
shall submit to the Project Officer and Contracting Officer an updated Option 3
Product Development Plan to accomplish the product development activities
detailed in the negotiated Statement of Work for Option 3.  This Plan shall be
updated following any milestone change or deviation during this Option.

 

19

--------------------------------------------------------------------------------

 

Within sixty (60) calendar days after the exercise of Option 4, the Contractor
shall submit to the Project Officer and Contracting Officer an updated Option 4
Product Development Plan to accomplish the product development activities
detailed in the negotiated Statement of Work for Option 4.  This Plan shall be
updated following any milestone change or deviation during this Option.

 

The Product Development Plan shall include:

 

a) clearly defined goals for each proposed stage of product development where
“Go/No Go” decision points have been identified;

 

b) quantitative and qualitative criteria for assessing the scientific merit and
feasibility of moving to the next stage of product development;

 

c) a detailed Gantt chart with a timeline with subtask, predecessor and
successor logic for each milestone covering the initiation, conduct and
completion of product development tasks; and

 

d) a task linked budget listing a breakdown of total costs linked to each
milestone, task and subtask.

 

2.               Implementation Plan

 

Within thirty (30) calendar days after the effective date of the contract and
prior to initiation of product development activities the Contractor shall
submit to the Project Officer and Contracting Officer an updated Implementation
Plan to accomplish the product development activities detailed in the negotiated
Statement of Work for the base period of performance, plus Options 1 and 2 (if
exercised).  This Plan shall be updated following any milestone change or
deviation.

 

Within sixty (60) calendar days after the exercise of Option 3, the Contractor
shall submit to the Project Officer and Contracting Officer an Option 3 updated
Implementation Plan to accomplish the product development activities detailed in
the negotiated Statement of Work for Option 3.  This Plan shall be updated
following any milestone change or deviation during this Option.

 

Within sixty (60) calendar days after the exercise of Option 4, the Contractor
shall submit to the Project Officer and Contracting Officer an Option 4 updated
Implementation Plan to accomplish the product development activities detailed in
the negotiated Statement of Work for Option 4.  This Plan shall be updated
following any milestone change or deviation during this Option.

 

The Implementation Plan shall contain a detailed discussion of the proposed
technical approach for each activity to be performed to achieve project
objectives in sufficient detail to explain and justify fully the
scientific/technical rationale for the proposed approaches and/or methodologies
and reflecting a clear understanding of the scope and nature of the work to be
carried out.

 

3.               Product Development Reports

 

The Contractor shall provide all Product Development Reports that document
compliance with the requirements of cGMP and product characterization and
release testing in compliance with GLP, including Shipping Validation Reports
and Chemistry, Manufacturing and Controls (CMC) information, and all raw data
and statistical analyses to the Project Officer and the NIAID Regulatory Affairs
designee.

 

4.               Non-Clinical Study Protocols and Reports

 

The Contractor shall provide to the Project Officer and to the NIAID Regulatory
Affairs designee Draft and Final Non-Clinical Study Protocols and Reports,
including associated Standard Operating Procedures (SOPs) and procedures
necessary to support the development and submission of IND applications to the
FDA.

 

20

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5.               Contract Initiation Meeting, Annual Contract Review Meetings,
and Additional Contract Meetings Reports

 

Reports of the Contract Initiation Meeting, the Annual Contract Review Meetings,
and the Additional Contract Meetings shall be prepared and submitted by the
Contractor to the Project Officer and Contracting Officer within twenty-one (21)
calendar days following each meeting.  These reports shall include a list of
attendees, summaries of discussions, and copies of all meeting materials.

 

6.               Publications and Presentation Materials

 

The Contractor shall provide manuscripts, scientific meeting abstracts, and oral
presentations containing data generated under this contract to the Project
Officer for review prior to submission for publication or public presentation.

 

a) Manuscripts shall be submitted no less than thirty (30) calendar days in
advance of submission.

 

b) Abstracts and oral presentations shall be submitted no less than ten
(10) calendar days in advance of presentation.

 

7.               Serious Adverse Events Reports

 

The Contractor shall submit Serious Adverse Events (SAE) Reports to the Project
Officer and to the NIAID Regulatory Affairs designee according to the NIAID
Clinical Terms of Award (http://www.niaidnih.gov/ncn/pdf/clinterm.pdf).

 

8.               Clinical Trial Monitoring Plan and Clinical Trial Protocols

 

The NIAID has a responsibility to ensure that mechanisms and procedures are in
place to protect the safety of participants in NIAID-funded clinical trials. 
Therefore, as described in the NIAID Clinical Terms of Award
(http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), the Contractor shall develop a
protocol for each clinical trial and submit all protocols and protocol
amendments for approval by the Project Officer.  Protocols must be submitted
using the approved DMID template and include a sample Informed Consent and
Clinical Trials Monitoring Plan.  The DMID templates and other important
information regarding performing human subjects research are available at
http://www3.niaid.nih.gov/research/resources/DMIDCIinRsrch//.

 

9.               FDA Correspondence and Meeting Summaries

 

The Project Officer and Project Officer’s designees shall be granted permission
by the Contractor to be an observer at all FDA meetings and teleconferences
related to any activities being performed as part of this contract, including
work performed by subcontractors and collaborators.  The Contractor shall
provide copies of all correspondence relating to this contract sent to and
received from the FDA and shall provide minutes of meetings held with the FDA
within five (5) calendar days after the meeting date to the Project Officer and
the NIAID Regulatory Affairs designee.

 

10.         Final Clinical Study Report

 

The Final Clinical Study Report shall follow the ICH guidelines on Structure and
Content of Clinical Study Reports E3
(http://www.pharmacontract.ch/support/su_ich_Iiste.htm).  Final Clinical Study
Reports shall be provided within thirty (30) calendar days after the completion
of the analysis of all clinical trial data to the Project Officer and the NIAID
Regulatory Affairs designee.

 

21

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ARTICLE C.3.  INVENTION REPORTING REQUIREMENT

 

All reports and documentation required by FAR Clause 52.227-11, Patent
Rights-Ownership by the Contractor including, but not limited to, the invention
disclosure report, the confirmatory license, and the Government support
certification, shall be directed to:

 

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(b)(2)(ii))
shall be submitted to the Contracting Officer on the completion date of the
contract.

 

The annual utilization report shall be submitted in accordance with the
DELIVERIES Article in SECTION F of this contract. The first annual utilization
report shall be due on or before due on or before the 30th of the month
following each anniversary date of the contract. The final invention statement
(see FAR 27.303(b)(2)(ii)) shall be submitted on the completion date of the
contract. All reports shall be sent to the following address:

 

Contracting Officer
MID Research Contract Branch-B
Office of Acquisitions, DEA, NIAID, NIH
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612

 

Direct Phone Number:  301-451-3690
Office Phone Number:  301-496-0612
Fax Number:  301-402-0972

 

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.

 

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.

 

22

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SECTION D - 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 E - 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 identified
in ARTICLE G.1. is the authorized representative of the Contracting Officer.

 

c.              Inspection and acceptance will be performed at:

 

National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Microbiology and Infectious Diseases
6610 Rockledge Drive
Bethesda, MD 20892

 

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 52.246-8, Inspection of Research and Development - Cost-Reimbursement
(May 2001).

 

23

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SECTION F  DELIVERIES OR PERFORMANCE

 

ARTICLE F.1.  PERIOD OF PERFORMANCE

 

a.              The period of performance of this contract shall be from
September 25, 2008 through September 24, 2011.

 

b.             If the Government exercises its option(s) pursuant to the OPTION
PROVISION Article in Section H of this contract, the period of performance will
be increased as listed below:

 

Option

 

Option Period

1 - Base Extension - Non- Clinical Development

 

Two (2) years beginning with the effective date of the exercise of Option 1.

2 - Base Extension - Phase I Clinical Trial

 

Two (2) years beginning with the effective date of the exercise of Option 2.

3 - Scale-Up and Validation

 

Five (5) years beginning with the effective date of the exercise of Option 3.

4 - Phase II Clinical Trial

 

Three (3) years beginning with the effective date of the exercise of Option 3.

 

ARTICLE F.2.  DELIVERIES

 

Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in the Statement of Work Article in SECTION C
of this contract 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:

 

The items specified below as described in the REPORTING REQUIREMENTS Article in
SECTION C of this contract 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 and any
specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this
contract:

 

a.               Reports and Deliverables

 

Item

 

Report/Deliverable

 

Delivery Schedule

1.

 

Monthly Progress Report

 

The first report is due on or before November 15, 2008. Thereafter, each report
is due on or before the 15th of the month following each reporting period.
Monthly Progress Reports are not required when an Annual Progress Report or
Final Report is due.

2.

 

Annual Progress Report

 

The first report is due on or before October 30, 2009. Thereafter, each report
is due on/before the 30th of the month following each anniversary date of the
contract. An Annual Progress Report is not due when a Final Report is due.

3.

 

Annual Technical Progress Report for Clinical Research Study Populations
(Options 2 and 4)

 

The first report is due the 30th of the month following the date
Option 2 is exercised. Thereafter, each report is due on or before the 30th of
the month following each anniversary date in
Options 2 and 4.

4.

 

Draft Final Report

 

Due 90 calendar days prior to the completion date of the contract.

5.

 

Final Report and Summary of Salient Results

 

Due on or before the completion date of the contract

6.

 

Contract Initiation Meeting, Annual Contract Review Meetings, and Additional
Contract Meetings Reports

 

Due within 21 calendar days following each meeting.

 

24

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Item

 

Report/Deliverable

 

Delivery Schedule

7.

 

Publications and Presentation Materials

 

Manuscripts are due 30 calendar days in advance of submission.

 

Abstracts and oral presentations are due 10 calendar days in advance of
presentation.

8.

 

Product Development Plans

 

Initial Updated Plan is due October 25, 2008 and following any milestone change
or deviation.

 

Option 3 Updated Plan is due 60 calendar days after the exercise of Option 3 and
following any milestone change or deviation.

 

Option 4 Updated Plan is due 60 calendar days after the exercise of Option 4 and
following any milestone change or deviation.

9.

 

Implementation Plans

 

Initial Updated Plan is due October 25, 2008 and following any milestone change
or deviation.

 

Option 3 Updated Plan is due 60 calendar days after the exercise of Option 3 and
following any milestone change or deviation.

 

Option 4 Updated Plan is due 60 calendar days after the exercise of Option 4 and
following any milestone change or deviation.

10.

 

Product Development Reports including:

 

Shipping Validation Reports;

 

Chemistry, Manufacturing and Controls (CMC) Information;

 

All raw data and statistical analyses

 

To be negotiated.

11.

 

Draft Non-Clinical Study Protocols and Reports

 

To be negotiated.

12.

 

Final Non-Clinical Study Protocols and Reports

 

To be negotiated.

13.

 

Standard Operating Procedures (SOPs)

 

To be negotiated.

14.

 

Serious Adverse Events (SAE) Reports

 

(Options 2 and 4 only)

 

In accordance with NIAID Clinical Terms of Award.

15.

 

Sample Informed Consent and Clinical Trial Monitoring Plan (Options 2 and 4
only)

 

In accordance with NIAID Clinical Terms of Award.

16.

 

Final Clinical Study Report

 

(Options 2 and 4 only)

 

Due 30 calendar days after the completion of the analysis of all clinical trial
data.

17.

 

Food and Drug Administration (FDA) Correspondence and Meeting Summaries

 

Due five (5) calendar days after the meeting is held or correspondence is sent.

18.

 

Process Development Final Report (SOW, Base Period, Milestone 1.a.)

 

Prior to technical transfer and scale up of process.

19.

 

Technical Transfer Audit Report and Quality Agreement Statement of Work (SOW,
Base
Period. Milestone 1.b.)

 

Prior to placing orders with CMO.

20.

 

Technical Transfer Completion Reports, including Analytical Qualification
Reports (SOW, Base Period, Milestone 1.b.)

 

Prior to GMP manufacture.

 

25

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Item

 

Report/Deliverable

 

Delivery Schedule

21.

 

Master Batch Records (MBRs) (SOW, Base Period, Milestone 1.c.)

 

Prior to production of the demonstration batches.

22.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis (SOW,
Base Period, Milestone 1.f.)

 

Within five (5) months after manufacture.

23.

 

Qualification of Process Assays Reports (SOW, Base Period, Milestone 2.a.)

 

Within 14 months after the effective date of the contract.

24.

 

Qualification of Product Assays Reports (SOW, Base Period, Milestone 2.b.)

 

Within 14 months after the effective date of the contract.

25.

 

Qualification of Stability Indicating Assays Reports (SOW, Base Period,
Milestone 2.c.)

 

Within 14 months after the effective date of the contract.

26.

 

Qualification of Immuno-Potency Assay Reports (SOW, Base Period, Milestone 2.d.)

 

Within 24 months after the effective date of the contract.

27.

 

Stability Trials Audit Report and Quality Agreement (SOW, Base Period, Milestone
3.0.)

 

Prior to placing orders with the Clinical Research Organization (CRO)

28.

 

cGMP Stability Protocols (SOW, Base Period, Milestone 3.0.)

 

One (1) month prior to the initiation of the stability study.

29.

 

Stability Study Report (SOW, Base Period, Milestone 3.0.)

 

Within 30 calendar days after completion of the study.

30.

 

Draft Safety and Toxicity Protocol(s) (SOW, Base Period, Milestone 4.a.)

 

To be negotiated.

31.

 

CRO Audit Report and Quality Agreement (SOW, Base Period, Milestone 4.a.)

 

To be negotiated.

32.

 

Acute Dose Safety and Toxicity Studies Reports (SOW, Base Period, Milestone
4.b.)

 

To be negotiated.

33.

 

Repeat Dose Safety and Toxicity Studies Reports (SOW, Base Period, Milestone
4.c.)

 

To be negotiated.

34.

 

Safety Pharmacology Study (SOW, Base Period, Milestone 4.d.)

 

To be negotiated.

35.

 

Final Documentation of FDA Concurrence (SOW, Base Period, Milestone 4.e.)

 

To be negotiated.

36.

 

A Draft Protocol, Animal Studies Group (ASG) Minutes and Concurrence for the
each of the following mouse model studies (SOW, Base Period, Milestone 5.a.) :

 

Excipient Effects;

 

Immunogencity;

 

Dose Ranging; and,

 

Adjuvant Requirements.

 

To be negotiated.

37.

 

Final Reports for the each of the following mouse model studies (SOW, Base
Period, Milestone 5.b.) :

 

Excipient Effects;

 

Immunogencity;

 

Dose Ranging:  and,

 

Adjuvant Requirements

 

To be negotiated.

 

26

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Item

 

Report/Deliverable

 

Delivery Schedule

38.

 

Non Clinical Study Rabbit Model Audit Report and Quality Agreement (SOW, Option
1 , Milestone 6.a.)

 

Prior to placing orders with the CRO.

39.

 

Non Clinical Study Rabbit Model Protocol (SOW, Option 1, Milestone 6.a.)

 

To be negotiated.

40.

 

Rabbit Model Immune Response Interim Report (SOW, Option 1, Milestone 6.c.)

 

To be negotiated.

41.

 

Rabbit Model Immune Response Final Report (SOW, Option 1, Milestone 6.c.)

 

To be negotiated.

42.

 

Animal Dose Ranging Challenge Study Interim Report (SOW, Option 1, Milestone
6.e.)

 

To be negotiated.

43.

 

Animal Dose Ranging Challenge Study Interim Report (SOW, Option 1, Milestone
6.e.)

 

To be negotiated.

44.

 

Non Clinical Study Non-Human Primate Model Audit Report and Quality Agreement
(SOW, Option 1, Milestone 7.a.)

 

Prior to placing orders with the CRO.

45.

 

Non Clinical Study Non-Human Primate Model Protocol (SOW, Option 1, Milestone
7.a.)

 

To be negotiated.

46.

 

Non-Human Primate Model Dose Ranging Challenge Study Interim Report (SOW, Option
1, Milestone 7.c.)

 

To be negotiated.

47.

 

Non-Human Primate Model Dose Ranging Challenge Study Final Report (SOW, Option
1, Milestone 7.c.)

 

To be negotiated.

48.

 

Passive Transfer Audit Report and Quality Agreement (SOW, Option 1, Milestone
8.a.)

 

Prior to placing orders with the CRO.

49.

 

Passive Transfer Protocol (SOW, Option 1, Milestone 8.a.)

 

To be negotiated.

50.

 

Passive Transfer Final Report (SOW, Option 1, Milestone 8.c.)

 

To be negotiated.

51.

 

Phase I Clinical Trial Audit Report and Quality Agreement (SOW, Option 2,
Milestone 9.a.)

 

Prior to placing orders with the CRO.

52.

 

Phase I Clinical Trial Documentation (including Protocol and Investigators
Brochure) (SOW, Option 2, Milestone 9.b.)

 

To be negotiated.

53.

 

Documentation of Interactions with CBER and CBER Concurrence (SOW, Option 2,
Milestone 9.c.)

 

To be negotiated.

54.

 

Phase I Clinical Trial Report (SOW, Option 2, Milestone 9.e.)

 

To be negotiated.

55.

 

2,000 Clinical Doses of cGMP Vaccine and Associated Certificate of Analysis
(SOW, Option 2, Milestone 11.a.)

 

To be negotiated.

56.

 

2,000 Doses of cGMP Diluent and Associated Certificate of Analysis (SOW, Option
2, Milestone 11.a.)

 

To be negotiated.

57.

 

Final Approved Master Batch Records (MBRs) for Process Scale-Up of Final Drug
Product (FDP)(SOW, Option 3, Milestone 13)

 

Prior to cGMP manufacture.

58.

 

Final Report of Process Scale-Up for FDP (SOW Option 3, Milestone 13)

 

To be negotiated.

 

27

--------------------------------------------------------------------------------

 

Item

 

Report/Deliverable

 

Delivery Schedule

59.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis for
Process Scale-Up of FDP (SOW, Option 3, Milestone 13)

 

Within six (6) months after manufacture.

60.

 

Final Approved Master Batch Records (MBRs) for Scale-Up of Diluent (SOW, Option
3, Milestone 14)

 

Prior to cGMP manufacture.

61.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis for
Scale Up of Diluent (SOW, Option 3, Milestone 14)

 

Within six (6) months after manufacture.

62.

 

Validation Master Plan (VMP) for FDP and Diluent (SOW, Option 3, Milestone 15)

 

Within six (6) months after exercising Option 3.

63.

 

FDP Process Validation Protocol (SOW, Option 3, Milestone 15)

 

To be negotiated.

64.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis for FDP
Process Validation (SOW, Option 3, Milestone 15)

 

Within five (5) months after manufacture.

65.

 

FDP Consistency Protocol with Validation Data and VMP (SOW, Option 3, Milestone
16)

 

To be negotiated.

66.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis for FDP
Consistency (SOW, Option 3, Milestone 16)

 

To be negotiated.

67.

 

Diluent Process Validation/Consistency Report (SOW, Option 3, Milestone 17)

 

To be negotiated.

68.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis for
Diluent Process Validation/Consistency (SOW, Option 3, Milestone 17)

 

Within five (5) months after manufacture.

69.

 

200,000 Doses of cGMP FDP Vaccine and Associated Certificate of Analysis (SOW,
Option 3, Milestone 16)

 

To be negotiated.

70.

 

200,000 Doses of cGMP FDP Diluent and Associated Certificate of Analysis (SOW,
Option 3, Milestone 16)

 

To be negotiated.

71.

 

Validation Reports for Each In-Process and Release Assay for FDP (SOW, Option 3,
Milestone 18)

 

To be negotiated.

72.

 

Validation Reports of the Stability of Non- Releasable Assays for FDP (SOW,
Option 3, Milestone 18)

 

To be negotiated.

73.

 

Validation Reports for Each In-Process and Release Assay for Diluent (SOW,
Option 3, Milestone 19)

 

To be negotiated.

74.

 

Validation Reports of the Stability of Non- Releasable Assays for Diluent (SOW,
Option 3, Milestone 19)

 

To be negotiated.

75.

 

Validation Report of Immunopotency Assay (SOW, Option 3, Milestone 20)

 

To be negotiated.

 

28

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Item

 

Report/Deliverable

 

Delivery Schedule

76.

 

Stability Study Reports for Testing of FDP Process Verification (SOW, Option 3,
Milestone 21)

 

To be negotiated.

77.

 

Stability Study Reports for Testing of FDP Process Validation (SOW, Option 3,
Milestone 21)

 

To be negotiated.

78.

 

Stability Study Report for Consistency Campaign for FDP (SOW, Option 3,
Milestone 21)

 

To be negotiated.

79.

 

Stability Study Reports for Testing of Diluent GMP Lot (SOW, Option 3, Milestone
22)

 

To be negotiated.

80.

 

Stability Study Reports for Testing of Diluent Process Validation/Consistency
(SOW, Option 3, Milestone 22)

 

To be negotiated.

81.

 

Executed Batch Manufacturing Records (BMRs) and Certificate of Analysis for
Phase II Clinical Trial (SOW, Option 4, Milestone 23)

 

Within five (5) months after manufacture.

82.

 

Stability Study Reports for Clinical Batches (SOW, Option 4, Milestone 23)

 

To be negotiated.

83.

 

Phase II Clinical Trial Audit Report and Quality Agreement (SOW, Option 4,
Milestone 25)

 

Prior to placing orders with the CRO.

84.

 

Phase II Clinical Trial Documentation (including Protocol and Investigators
Brochure) (SOW, Option 4, Milestone 25)

 

To be negotiated.

85.

 

Documentation of Interactions with CBER and CBER Concurrence (SOW Option 4,
Milestone 25)

 

To be negotiated.

86.

 

Phase II Clinical Trial Report (SOW, Option 4, Milestone 25)

 

To be negotiated.

87.

 

Passive Transfer Study Using Clinical Trial Material Documentation of
Interaction with and Concurrence from the Animal Studies Group (SOW, Option 4,
Milestone 26)

 

To be negotiated.

88.

 

Passive Transfer Study Using Clinical Trial Material Final Report (SOW, Option
4, Milestone 26)

 

To be negotiated.

89.

 

Human Subjects Annual IRB Report (Options 2 and 4)

 

Due annually during the Option periods.

90.

 

Annual Utilization Report

 

Due on or before the 30th of the month following each anniversary date of the
contract.

91.

 

Final Invention Statement

 

Due on or before the completion date of the contract.

 

29

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b.              Copies of reports shall be sent to the following addressees:

 

Recipient

 

Address

 

Item No.

 

Quantity and Format

Project Officer

 

[* * *]

 

[* * *]

 

1 hard copy, 1 electronic copy

 

 

 

 

 

 

 

Contracting Officer

 

[* * *]

 

[* * *]

 

1 original, 1 electronic copy

 

 

 

 

 

 

 

NIAID Regulatory Affairs designee

 

[* * *]

 

[* * *]

 

1 hard copy, 1 electronic copy

 

 

 

 

 

 

 

Designated DMID Repository

 

[* * *]

 

[* * *]

 

2,000 Clinical Doses of cGMP Vaccine and Associated Certificate of Analysis

 

 

 

 

 

 

 

Designated DMID Repository

 

[* * *]

 

[* * *]

 

2,000 Doses of cGMP Diluent and Associated Certificate of Analysis

 

 

 

 

 

 

 

Designated DMID Repository

 

[* * *]

 

[* * *]

 

200,000 Doses of cGMP FDP Vaccine and Associated Certificate of Analysis

 

 

 

 

 

 

 

Designated DMID Repository

 

[* * *]

 

[* * *]

 

200,000 Doses of cGMP FDP Diluent and Associated Certificate of Analysis

 

 

 

 

 

 

 

OPERA

 

[* * *]

 

[* * *]

 

1 hard copy

 

30

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ARTICLE F.3.  CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

 

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. Also, the full text of a clause may
be accessed electronically at this address: 
http://www.acquisition.gov/comp/far/index.html

 

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

 

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

 

31

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SECTION G - CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1.  PROJECT OFFICER

 

The following Project Officer will represent the Government for the purpose of
this contract:

 

[* * *]

 

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 for any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.

 

The Government may unilaterally change its Project Officer designation.

 

ARTICLE G.2.  KEY PERSONNEL, HHSAR 352.270-5 (January 2006)

 

The key personnel specified in this contract are considered to be essential to
work performance. At least 30 days prior to diverting any of the specified
individuals to other programs or contracts (or as soon as possible, if an
individual must be replaced, for example, as a result of leaving the employ of
the Contractor), the Contractor shall notify the Contracting Officer and shall
submit comprehensive justification for the diversion or replacement request
(including proposed substitutions for key personnel) to permit evaluation by the
Government of the impact on performance under this contract. The Contractor
shall not divert or otherwise replace any key personnel without the written
consent of the Contracting Officer. The Government may modify the contract to
add or delete key personnel at the request of the Contractor or Government.

 

(End of Clause)

 

The following individual is considered to be essential to the work being
performed hereunder:

 

Name

 

Title

[***]

 

Principal Investigator

 

32

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ARTICLE G.3.  INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT

 

a.              Invoice/Financing Request Instructions and Contract Financial
Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and
made part of this contract. The Contractor shall follow the attached
instructions and submission procedures specified below to meet the requirements
of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

 

1.              Invoices shall be submitted as identified below. Do not submit
supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.)
with your invoice unless specified elsewhere in the contract or requested by the
Contracting Officer.

 

A.              THE ORIGINAL HARD COPY INVOICE SHALL BE SUBMITTED TO THE
FOLLOWING DESIGNATED BILLING OFFICE:

 

National Institutes of Health
Office of Financial Management
Commercial Accounts
2115 East Jefferson Street, Room 4B-432, MSC 8500
Bethesda, MD 20892-8500

 

B.             THE CONTRACTOR SHALL SUBMIT AN ELECTRONIC COPY OF THE INVOICE TO
THE CONTRACTING OFFICER INSTEAD OF A PAPER COPY. THE INVOICE SHALL BE
TRANSMITTED AS AN ATTACHMENT VIA E-MAIL TO THE NIAID OA CENTRAL INVOICE E-MAIL
ADDRESS LISTED BELOW. THE SUBJECT LINE OF THE E-MAIL MUST INCLUDE THE FOLLOWING
INFORMATION:  NAME OF CONTRACTOR, CONTRACT NUMBER, AND UNIQUE INVOICE NUMBER.
ONLY ONE (1) INVOICE SHOULD BE SUBMITTED PER EMAIL. THE INVOICE SHOULD BE IN
ADOBE PDF FORMAT, THOUGH A MS WORD OR MS EXCEL FORMAT WILL ALSO BE CONSIDERED
ACCEPTABLE. [NOTE:  THE ORIGINAL INVOICE MUST STILL BE SUBMITTED IN HARD COPY
AND MAILED TO THE DESIGNATED BILLING OFFICE TO MEET THE REQUIREMENTS OF A
“PROPER INVOICE”.]
E-MAIL:  NIAIDOALNVOICES@NIAID.NIH.GOV

 

2.              In addition to the requirements specified in FAR Subpart 32.905
for a proper invoice, the Contractor shall include the following information on
the face page of all invoices:

 

A.              NAME OF THE OFFICE OF ACQUISITIONS. THE OFFICE OF ACQUISITIONS
FOR THIS CONTRACT IS NIAID.

 

B.             CENTRAL POINT OF DISTRIBUTION. FOR THE PURPOSE OF THIS CONTRACT,
THE CENTRAL POINT OF DISTRIBUTION IS NIAIDOAINVOICES.

 

C.              FEDERAL TAXPAYER IDENTIFICATION NUMBER (TIN). IF THE CONTRACTOR
DOES NOT HAVE A VALID TIN, IT SHALL IDENTIFY THE VENDOR IDENTIFICATION NUMBER
(VIN) ON THE INVOICE. THE VIN IS THE NUMBER THAT APPEARS AFTER THE CONTRACTOR’S
NAME IN BLOCK 7 ON THE FACE PAGE OF THE CONTRACT. IF THE CONTRACTOR HAS NEITHER
A TIN, DUNS, OR VIN, THEY SHOULD CONTACT THE CONTRACTING OFFICER.

 

D.             DUNS OR DUNS+4 NUMBER. THE DUNS NUMBER MUST IDENTIFY THE
CONTRACTOR’S NAME AND ADDRESS EXACTLY AS STATED IN THE CONTRACT AND AS
REGISTERED IN THE CENTRAL CONTRACTOR REGISTRATION (CCR) DATABASE. IF THE
CONTRACTOR DOES NOT HAVE A VALID DUNS NUMBER, IT SHALL IDENTIFY THE VIN NUMBER
ON THE INVOICE. IF THE CONTRACTOR HAS NEITHER A TIN, DUNS, OR VIN, THEY SHOULD
CONTACT THE CONTRACTING OFFICER.

 

E.              INVOICE MATCHING OPTION. THIS CONTRACT REQUIRES A TWO-WAY MATCH.

 

33

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F.                UNIQUE INVOICE NUMBER. EACH INVOICE MUST BE IDENTIFIED BY A
UNIQUE INVOICE NUMBER, WHICH CAN ONLY BE USED ONE TIME REGARDLESS OF THE NUMBER
OF CONTRACTS OR ORDERS HELD BY AN ORGANIZATION.

 

b.             Inquiries regarding payment of invoices shall be directed to the
designated billing office, (301) 496-6452.

 

c.              The Contractor shall 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.

 

F.                CONSULTANT FEES - IDENTIFY INDIVIDUALS AND AMOUNTS. CITE COA,
IF APPROPRIATE.

 

G.             SUBCONTRACTS - ATTACH SUBCONTRACTOR INVOICE(S).

 

H.             EQUIPMENT - CITE COA, IF APPROPRIATE, AND AMOUNT.

 

I.                 G&A - CITE RATE AND AMOUNT.

 

J.                 TOTAL COST

 

K.              FIXED FEE

 

L.                 TOTAL COST PLUS FIXED FEE

 

Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government.

 

Monthly invoices must also include a Summary page along with separate pages for
costs billed per each Milestone.

 

ARTICLE G.4.  INDIRECT COST RATES

 

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in PART II, SECTION I, the cognizant Contracting Officer
representative responsible for negotiating provisional and/or final indirect
cost rates is identified as follows:

 

Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 Executive Blvd., MSC-7540
Bethesda, MD 20892-7540

 

These rates are hereby incorporated without further action of the Contracting
Officer.

 

34

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ARTICLE G.5.  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 HHS Publication, “Contractor’s Guide for Control
of Government Property,” which is incorporated into this contract by reference.
This document can be accessed at:

 

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf.

 

Among other issues, this publication provides a summary of the Contractor’s
responsibilities regarding purchasing authorizations and inventory and reporting
requirements under the contract. 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 Boulevard MSC 7670
Bethesda, MD 20892-7670
(301) 496-6466

 

ARTICLE G.6.  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 shall be submitted as determined by the Project Officer and
the Contracting Officer, but at least once during the life 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.

 

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.

 

b.             Electronic Access to Contractor Performance Evaluations

 

Contractors that have Internet capability may access evaluations through a
secure Web site for review and comment by completing the registration form that
can be obtained at the following address:

 

http://oamp.od.nih.gov/OD/CPS/cps.asp

 

The registration process requires the Contractor to identify an individual that
will serve as a primary contact and who will be authorized access to the
evaluation for review and comment. In addition, the Contractor will be required
to identify an alternate contact who will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.

 

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

 

ARTICLE H.1.  HUMAN SUBJECTS

 

Research involving human subjects shall not be conducted under this contract
until the protocol developed in Phase I has been approved by NIAID, written
notice of such approval has been provided by the Contracting Officer, and the
Contractor has provided to the Contracting Officer a properly completed
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the protocol. The human
subject certification can be met by submission of the Contractor’s self
designated form, provided that it contains the information required by the
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310).

 

The Contractor is required to submit the Form OMB No. 0990-0263 on an annual
basis beginning with the effective date of the contract, or the exercise of
Options, as applicable.

 

When research involving human subjects will take place at collaborating sites or
other performance sites, the Contractor shall obtain, and keep on file, a
properly completed “Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the research.

 

ARTICLE H.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/grants/guide/notice-files/NOT-OD-00-039.html.

 

The information below is a summary of the NIH Policy 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.

 

ARTICLE H.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
and any other data and safety monitoring requirements found elsewhere in this
contract.

 

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Data and Safety Monitoring shall be performed in accordance with the approved
Data and Safety Monitoring Plan.

 

The Data and Safety Monitoring Board shall be established and approved prior to
beginning the conduct of the clinical trial.

 

ARTICLE H.4.  REGISTRATION OF CLINICAL TRIALS IN THE GOVERNMENT DATABASE
(ClinicalTrials.gov)

 

Pursuant to Public Law 110-85, Food and Drug Administration Amendments Act of
2007, Title VIII-Clinical Trial Databases, the Contractor shall register the
clinical trial(s) performed under this contract in the Government database,
ClinicalTrials.gov ( http://www.ClinicalTrials.gov) by the later of December 27,
2007, or 21 days after the first patient is enrolled.

 

Additional information is available at:  http://prsinfo.clinicaltrials.gov .

 

ARTICLE H.5.  HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

 

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.

 

The Contractor shall provide written documentation that all human materials
obtained as a result of research involving human subjects conducted under this
contract, by collaborating sites, or by subcontractors identified under this
contract, were obtained with 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 Contractor.

 

Provision by the Contractor to the Contracting Officer of a properly completed
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly
Optional Form 310), certifying IRB review and approval of the protocol from
which the human materials were obtained constitutes the written documentation
required. The human subject certification can be met by submission of a self
designated form, provided that it contains the information required by the
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly
Optional Form 310).

 

ARTICLE H.6.  RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene
Transfer Research)

 

All research involving Recombinant DNA Molecules shall be conducted in
accordance with the NIH Guidelines for Research Involving Recombinant DNA
Molecules ( http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) and the
September 24, 2007 Notice, “Reminder of NIH Policy for Enhancing the Science,
Safety, and Ethics of Recombinant DNA Research”
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-096.html) (and any
subsequent revisions to the Guide Notice) which stipulates biosafety and
containment measures for recombinant DNA research and delineates critical,
ethical principles and key safety reporting requirements for human gene transfer
research (See Appendix M of the Guidelines). These guidelines apply to both
basic and clinical research studies.

 

The Recombinant DNA Advisory Committee (RAC) is charged with the safety of
manipulation of genetic material through the use of recombinant DNA techniques.
Prior to beginning any clinical trials involving the transfer of recombinant DNA
to humans, the trial must be registered with the RAC. If this contract involves
new protocols that contain unique and/or novel issues, the RAC must discuss them
in a public forum and then the Institutional Biosafety Committee (IBC), the
Institutional Review Board (IRB), and the Project Officer and Contracting
Officer must approve the protocol prior to the start of the research.

 

Failure to comply with these requirements may result in suspension, limitation,
or termination of the contract for any work related to Recombinant DNA Research
or a requirement for Contracting Officer prior approval of any or all

 

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Recombinant DNA projects under this contract. This includes the requirements of
the Standing Institutional Biosafety Committee (IBC) (See
http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm ).

 

As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious adverse
event must be reported immediately to the IRB, the IBC, the Office for Human
Research Protections (if applicable), and the NIH Office for Biotechnology
Activities (OBA), followed by the filing of a written report with each
office/group and copies to the Project Officer and Contracting Officer.
(http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255836)

 

ARTICLE H.7.  CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds 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 46.204(b) 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.

 

ARTICLE H.8.  NEEDLE EXCHANGE

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds to carry out any program of distributing sterile needles or
syringes for the hypodermic injection of any illegal drug.

 

ARTICLE H.9.  PRESS RELEASES

 

Pursuant to the current HHS annual appropriations act, 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.

 

ARTICLE H.10.  DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC
INFORMATION

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds to disseminate scientific information that is deliberately
false or misleading.

 

ARTICLE H.11.  RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds to employ workers described in section 274A(h)(3) of the
Immigration and Nationality Act, which reads as follows:

 

“(3) Definition of unauthorized alien. - As used in this section, the term
‘unauthorized alien’ means, with respect to the employment of an alien at a
particular time, that the alien is not at that time either (A) an alien lawfully
admitted for permanent residence, or (B) authorized to be so employed by this
Act or by the Attorney General.”

 

ARTICLE H.12.  RESTRICTION ON ABORTIONS

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds for any abortion.

 

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ARTICLE H.13.  SALARY RATE LIMITATION LEGISLATION PROVISIONS

 

a.              Pursuant to the current HHS annual appropriations act, the
Contractor shall not use NIH Fiscal Year funds to pay the direct salary of an
individual through this contract at a rate in excess of Executive Level I.
Direct salary is exclusive of fringe benefits, overhead and general and
administrative expenses (also referred to as “indirect costs” 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 annual salary rate limitation 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 used
to establish contract funding exceeds any salary rate limitation subsequently
established in future HHS appropriation acts.

 

b.             Payment of direct salaries is limited to the Executive Level I
rate which was in effect on the date(s) the expense was incurred. See the
following Web site for Executive Schedule rates of pay:
 http://www.opm.gov/oca/. (For current year rates, click on Salaries and Wages /
Executive Schedule / Rates of Pay for the Executive Schedule. For prior year
rates, click on Salaries and Wages /cursor to bottom of page and select year/
Executive Schedule / Rates of Pay for the Executive Schedule. Rates are
effective January 1 of each calendar year unless otherwise noted.)

 

ARTICLE H.14.  PRIVACY ACT, HHSAR 352.270-11 (January 2006)

 

This contract requires the Contractor to perform one or more of the following: 
(a) Design; (b) develop; or (c) operate a Federal agency system of records to
accomplish an agency function in accordance with the Privacy Act of 1974 (Act)
(5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term “system of
records” means a group of any records under the control of any agency from which
information is retrieved by the name of the individual or by some identifying
number, symbol, or other identifying particular assigned to the individual.

 

Violations of the Act by the Contractor and/or its employees may result in the
imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure
that each of its employees knows the prescribed rules of conduct and that each
employee is aware that he/she is subject to criminal penalties for violation of
the Act to the same extent as HHS employees. These provisions also apply to all
subcontracts awarded under this contract which require the design, development
or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)).

 

The contract work statement:  (a) Identifies the system(s) of records and the
design, development, or operation work to be performed by the Contractor; and
(b) specifies the disposition to be made of such records upon completion of
contract performance.

 

(End of clause)

 

45 CFR Part 5b contains additional information which includes the rules of
conduct and other Privacy Act requirements and can be found at: 
http://www.access.apo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

 

The Privacy Act System of Records applicable to this project is Number
09-25-0200. This document is available at: 
http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm.

 

ARTICLE H.15.  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://grants1.nih.gov/grants/olaw/references/phspol.htm.

 

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ARTICLE H.16.  PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

 

All Contractor personnel who work with nonhuman primates or enter rooms or areas
containing nonhuman primates shall comply with the procedures set forth in NIH
Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with
Nonhuman Primates,” located at the following URL:

 

http://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/

 

ARTICLE H.17.  OMB CLEARANCE or CLINICAL EXEMPTION

 

In accordance with HHSAR 352.270-7, Paperwork Reduction Act, the Contractor
shall not proceed with surveys or interviews until such time as Office of
Management and Budget (OMB) Clearance for conducting interviews has been
obtained by the Project Officer and the Contracting Officer has issued written
approval to proceed.  In addition, in accordance with 5 CFR 1320.3(h)(5), this
requirement may be eligible for a Clinical Exemption to OMB Clearance
requirements subject to the approval of the NIH Clinical Exemption Review
Committee (CERC).  The clinical exemption must be obtained and written approval
to proceed received from the Project Officer and Contracting Officer before data
is collected under this contract or any subcontract.

 

ARTICLE H.18.  OPTION PROVISION

 

Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., the contract will consist only of the Base Period of the
Statement of Work as defined in Sections C and F of the contract.  Pursuant to
FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item
set forth in ARTICLE I.3. of this contract, the Government may, by unilateral
contract modification, require the Contractor to perform additional options set
forth in the Statement of Work and also defined in Sections C and F of the
contract.  If the Government exercises this option, notice must be given at
least 60 days prior to the completion date of this contract, and the estimated
cost plus fixed fee of the contract will be increased as set forth in
Article B.2. of this contract.

 

ARTICLE H.19.  INFORMATION SECURITY

 

The Statement of Work (SOW) requires the Contractor to (1) develop, (2) have the
ability to access, or (3) host and/ or maintain a Federal information
system(s).  Pursuant to Federal and HHS Information Security Program Policies,
the Contractor and any subcontractor performing under this contract shall comply
with the following requirements:

 

Federal Information Security Management Act of 2002 (FISMA), Title Ill,
E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002);
http://csrc.nist.gov/drivers/documents/FISMA-final.pdf

 

a.               Information Type

 

x Administrative, Management and Support Information

Scientific and Technical Research and Innovation

o Mission Based Information

 

 

b.              Security Categories and Levels

 

Confidentiality Level:

x Low

o Moderate

o High

Integrity Level:

o Low

x Moderate

o High

Availability Level.

x Low

o Moderate

o High

 

 

 

 

Overall Level:

o Low

x Moderate

o High

 

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c.               Position Sensitivity Designations

 

1.               The following position sensitivity designations and associated
clearance and investigation requirements apply under this contract.

 

o Level 6:  Public Trust - High Risk (Requires Suitability Determination with a
BI).  Contractor employees assigned to a Level 6 position are subject to a
Background Investigation (BI)

 

o Level 5:  Public Trust - Moderate Risk (Requires Suitability Determination
with NACIC, MBI or LBI).  Contractor employees assigned to a Level 5 position
with no previous investigation and approval shall undergo a National Agency
Check and Inquiry Investigation plus a Credit Check (NACIC), a Minimum
Background Investigation (MBI), or a Limited Background Investigation (LBI).

 

x Level 1:  Non Sensitive (Requires Suitability Determination with an NACI). 
Contractor employees assigned to a Level 1 position are subject to a National
Agency Check and Inquiry Investigation (NACI).

 

2.               The Contractor shall submit a roster, by name, position, e-mail
address, phone number and responsibility, of all staff (including subcontractor
staff) working under the contract who will develop, have the ability to access,
or host and/or maintain a Federal information system(s).  The roster shall be
submitted to the Project Officer, with a copy to the Contracting Officer, within
14 calendar days of the effective date of the contract.  Any revisions to the
roster as a result of staffing changes shall be submitted within 15 calendar
days of the change.  The Contracting Officer shall notify the Contractor of the
appropriate level of suitability investigations to be performed.  An electronic
template, “Roster of Employees Requiring Suitability Investigations,” is
available for Contractor use at: 
http://ais.nci.nihgov/forms/Suitability-roster.xls.

 

Upon receipt of the Government’s notification of applicable Suitability
Investigations required, the Contractor shall complete and submit the required
forms within 30 days of the notification.  Additional submission instructions
can be found at the “NCI Information Technology Security Policies, Background
Investigation Process” website:  http://ais.nci.nih.gov.

 

Contractor/subcontractor employees who have met investigative requirements
within the past five years may only require an updated or upgraded
investigation.

 

3.               Contractor/subcontractor employees shall comply with the HHS
criteria for the assigned position sensitivity designations prior to performing
any work under this contract.  The following exceptions apply:

 

Levels 5 and 1:  Contractor/subcontractor employees may begin work under the
contract after the Contractor has submitted the name, position and
responsibility of the employee to the Project Officer, as described in paragraph
c. (2) above.

 

Level 6:  In special circumstances the Project Officer may request a waiver of
the pre-appointment investigation.  If the waiver is granted, the Project
Officer will provide written authorization for the Contractor/subcontractor
employee to work under the contract.

 

d.              Information Security Training

 

The Contractor shall ensure that each Contractor/subcontractor employee has
completed the NIH Computer Security Awareness Training course at: 
http://irtsectraining.nih.gov, prior to performing any contract work, and
thereafter completing the NIH-specified fiscal year refresher course during the
period of performance of the contract.

 

The Contractor shall maintain a listing by name and title of each
Contractor/subcontractor employee working under this contract that has completed
the NIH required training.  Any additional security training completed by
Contractor/subcontractor staff shall be included on this listing.  The listing
of completed training shall be included in the first monthly progress report. 
(See Article C.2. Reporting Requirements ) Any revisions to this listing as a
result of staffing changes shall be submitted with next required monthly
progress report.

 

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e.               Rules of Behavior

 

The Contractor/subcontractor employees shall comply with the NIH Information
Technology General Rules of Behavior at: 
http://irm.cit.nih.gov/security/nihitrob.html.

 

f.                 Personnel Security Responsibilities

 

Contractor Notification of New and Departing Employees Requiring Background
Investigations

 

1.               The Contractor shall notify the Contracting Officer, the
Project Officer, and the Security Investigation Reviewer within five (5) working
days before a new employee assumes a position that requires a suitability
determination or when an employee with a security clearance stops working under
the contract.  The Government will initiate a background investigation on new
employees requiring security clearances and will stop pending background
investigations for employees that no longer work under the contract.

 

2.               New employees:  Provide the name, position title, e-mail
address, and phone number of the new employee.  Provide the name, position title
and suitability level held by the former incumbent.  If the employee is filling
a new position, provide a description of the position and the Government will
determine the appropriate security level.

 

3.               Departing employees:

 

·                  Provide the name, position title, and security clearance
level held by or pending for the individual.

 

·                  Perform and document the actions identified in the “Employee
Separation Checklist”, attached in Section J, ATTACHMENTS of this contract, when
a Contractor/subcontractor employee terminates work under this contract.  All
documentation shall be made available to the Project Officer and/or Contracting
Officer upon request.

 

g.              Commitment to Protect Non-Public Departmental Information
Systems and Data

 

1.               Contractor Agreement

 

The Contractor and its subcontractors performing under this Statement of Work
shall not release, publish, or disclose non-public Departmental information to
unauthorized personnel, and shall protect such information in accordance with
provisions of the following laws and any other pertinent laws and regulations
governing the confidentiality of such information:

 

· 18 U.S.C. 641 (Criminal Code:  Public Money, Property or Records)
· 18 U.S.C. 1905 (Criminal Code:  Disclosure of Confidential Information)
· Public Law 96-511 (Paperwork Reduction Act)

 

2.               Contractor-Employee Non-Disclosure Agreements

 

Each Contractor/subcontractor employee who may have access to non-public
Department information under this contract shall complete the Commitment to
Protect Non-Public Information - Contractor Agreement.  A copy of each signed
and witnessed Non-Disclosure agreement shall be submitted to the Project Officer
prior to performing any work under the contract.

 

h.              NIST SP 800-53 Self-Assessment

 

The Contractor shall annually update and re-submit its Self-Assessment required
by NIST SP 800-53, Recommended Security Controls for Federal Information
Systems.  (http://csrc.nist.gov/publications - under Special Publications).

 

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Subcontracts:  The Contractor’s annual update to its Self-Assessment
Questionnaire shall include similar information for any subcontractor that
performs under the Statement of Work to (1) develop a Federal information
system(s) at the Contractor’s/subcontractor’s facility, or (2) host and/or
maintain a Federal information system(s) at the Contractor’s/subcontractor’s
facility.

 

The annual update shall be submitted to the Project Officer, with a copy to the
Contracting Officer.  For the option periods:  no later than the completion date
of the option period of performance.

 

i.                  Information System Security Plan

 

The Contractor’s draft ISSP submitted with its proposal shall be finalized in
coordination with the Project Officer no later than 90 calendar days after
contract award.

 

Following approval of its draft ISSP, the Contractor shall update and resubmit
its ISSP to the Project Officer every three (3) years or when a major
modification has been made to its internal system.  The Contractor shall use the
current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing
Security Plans for Federal Information Systems. 
(http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf). 
The details contained in the Contractor’s ISSP shall be commensurate with the
size and complexity of the requirements of the Statement of Work based on the
System Categorization determined above in subparagraph (b) Security Categories
and Levels of this Article.

 

Subcontracts:  The Contractor shall include similar information for any
subcontractor performing under the Statement of Work with the Contractor
whenever the submission of an ISSP is required.

 

j.                  Common Security Configurations

 

The Contractor shall ensure that any information technology acquired under this
contract incorporates the applicable common security configuration established
by the National Institute of Standards and Technology (NIST) at
http://checklists.nist.gov.

 

ARTICLE H.20.  ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY
(January 2008)

 

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as
amended by the Workforce Investment Act of 1998, all electronic and information
technology (EIT) products and services developed, acquired, maintained, and/or
used under this contract/order must comply with the “Electronic and Information
Technology Accessibility Provisions” set forth by the Architectural and
Transportation Barriers Compliance Board (also referred to as the “Access
Board”) in 36 CFR part 1194.  Information about Section 508 provisions is
available at http:// www.section508.gov/.  The complete text of Section 508
Final provisions can be accessed at
http://www.access-board.gov/sec508/provisions.htm.

 

The Section 508 standards applicable to this contract/order are identified in
the Statement of Work.  The Contractor must provide a written Section 508
conformance certification due at the end of each order/contract exceeding
$100,000 when the order/contract duration is one year or less.  If it is
determined by the Government that EIT products and services provided by the
Contractor do not conform to the described accessibility in the Product
Assessment Template, remediation of the products and/or services to the level of
conformance specified in the vendor’s Product Assessment Template will be the
responsibility of the Contractor at its own expense.

 

In the event of a modification(s) to the contract/order, which adds new EIT
products and services or revised the type of, or specifications for, products
and services the Contractor is to provide, including EIT deliverables such as
electronic documents and reports.  The Contracting Officer may require that the
Contractor submit a completed HHS Section 508 Product Assessment Template to
assist the Government in determining that the EIT products and services support
Section 508 accessibility requirements.  Instructions for documenting
accessibility via the HHS Section 508 Product Assessment Template may be found
at http://508 hhs gov.

 

[End of HHSAR 352.270-19(b)]

 

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Prior to the Contracting Officer exercising an option for a subsequent
performance period/additional quantity or adding increment funding for a
subsequent performance period under this contract, as applicable, the Contractor
must provide a Section 508 Annual Report to the Contracting Officer and
Contracting Officer’s Technical Representative (also known as Project Officer or
Contracting Officer’s Representative).  Unless otherwise directed by the
Contracting Officer in writing, the Contractor shall provide the cited report in
accordance with the following schedule.  Instructions for completing the report
are available at:  http://508.hhs.gov/ under the heading Vendor Information and
Documents.  The Contractor’s failure to submit a timely and properly completed
report may jeopardize the Contracting Officer’s exercising an option or adding
incremental funding, as applicable.

 

Schedule for Contractor Submission of Section 508 Annual Report:  To be included
with the Annual Progress Report.

 

[End of HHSAR 352.270-19(c)]

 

ARTICLE H.21.  INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF
INVESTIGATORS

 

The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing
standards to ensure that investigators (defined as the principal investigator
and any other person who is responsible for the design, conduct, or reporting of
research funded under NIH contracts) will not be biased by any conflicting
financial interest.  45 CFR Part 94 is available at the following

Web site:  http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=cc7504e541

bc62939c52389e9afc27d5&rgn=div5&view=text&node=45:1.0.1.1.51 &idno=45

 

As required by 45 CFR Part 94, the Contractor shall, at a minimum:

 

a.               Maintain a written, enforceable policy on conflict of interest
that complies with 45 CFR Part 94 and inform each investigator of the policy,
the investigator’s reporting responsibilities, and the applicable regulations. 
The Contractor must take reasonable steps to ensure that investigators working
as collaborators or subcontractors comply with the regulations.

 

b.              Designate an official(s) to solicit and review financial
disclosure statements from each investigator participating in NIH-funded
research.  Based on established guidelines consistent with the regulations, the
designated official(s) must determine whether a conflict of interest exists, and
if so, determine what actions should be taken to manage, reduce, or eliminate
such conflict.  A conflict of interest exists when the designated
official(s) reasonably determines that a Significant Financial Interest could
directly and significantly affect the design, conduct, or reporting of the
NIH-funded research.  The Contractor may require the management of other
conflicting financial interests in addition to those described in this
paragraph, as it deems appropriate.  Examples of conditions or restrictions that
might be imposed to manage actual or potential conflicts of interests are
included in 45 CFR Part 94, under Management of Conflicting Interests.

 

c.               Require all financial disclosures to be updated during the
period of the award, either on an annual basis or as new reportable Significant
Financial Interests are obtained.

 

d.              Maintain records, identifiable to each award, of all financial
disclosures and all actions taken by the Contractor with respect to each
conflicting interest 3 years after final payment or, where applicable, for the
other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records
Retention.

 

e.               Establish adequate enforcement mechanisms and provide for
sanctions where appropriate.

 

If a conflict of interest is identified, the Contractor shall report to the
Contracting Officer, the existence of the conflicting interest found.  This
report shall be made and the conflicting interest managed, reduced, or
eliminated, at least on a temporary basis, within sixty (60) days of that
identification.

 

If the failure of an investigator to comply with the conflict of interest policy
has biased the design, conduct, or reporting of the NIH-funded research, the
Contractor must promptly notify the Contracting Officer of the corrective action
taken or to be taken.  The Contracting Officer will take appropriate action or
refer the matter to the Contractor for

 

44

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further action, which may include directions to the Contractor on how to
maintain appropriate objectivity in the funded research.

 

The Contracting Officer may at any time inquire into the Contractor’s procedures
and actions regarding conflicts of interests in NIH-funded research, including a
review of all records pertinent to compliance with 45 CFR Part 94.  The
Contracting Officer may require submission of the records or review them on
site.  On the basis of this review, the Contracting Officer may decide that a
particular conflict of interest will bias the objectivity of the NIH-funded
research to such an extent that further corrective action is needed or that the
Contractor has not managed, reduced, or eliminated the conflict of interest. 
The issuance of a Stop Work Order by the Contracting Officer may be necessary
until the matter is resolved.

 

If the Contracting Officer determines that NIH-funded clinical research, whose
purpose is to evaluate the safety or effectiveness of a drug, medical device, or
treatment, has been designed, conducted, or reported by an investigator with a
conflict of interest that was not disclosed or managed, the Contractor must
require disclosure of the conflict of interest in each public presentation of
the results of the research.

 

ARTICLE H.22.  PUBLICATION AND PUBLICITY

 

In addition to the requirements set forth in HHSAR Clause 352.270-6,
Publications and Publicity incorporated by reference in SECTION I of this
contract, 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
Health, Department of Health and Human Services, under Contract
No. HHSN272200800049C”

 

ARTICLE H.23.  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 H.24.  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.

 

45

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ARTICLE H.25.   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 serve 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.html

 

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.gov/ocr/).  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 o the identity of individual subjects.

 

ARTICLE H.26.   POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR
TOXINS

 

The Contractor shall not conduct work involving select agents or toxins under
this contract until it and any associate subcontractors comply with the
following:

 

For prime or subcontract awards to domestic institutions that possess, use,
and/or transfer Select Agents under this contract, the institution must comply
with the provisions of 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 (
http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ) as
required, before using NIH funds for work involving a Select Agent or Toxin.  No
NIH funds can be used for research involving a Select Agent or Toxin at a
domestic institution without a valid registration certificate.

 

For prime or subcontract awards to foreign institutions that possess, use,
and/or transfer a Select Agent or Toxin, before using NIH funds for any work
directly involving a Select Agent or Toxin, the foreign institution must provide
information satisfactory to the NIAID that safety, security, and training
standards equivalent to those described in 42 CFR part 73, 7 CFR part 331,
and/or 9 CFR part 121 are in place and will be administered on behalf of all
Select Agent or Toxin work supported by these funds.  The process for making
this determination includes inspection of the foreign laboratory facility by an
NIAID representative.  During this inspection, the foreign institution must
provide the following information:  concise summaries of safety, security, and
training plans; names of individuals at the foreign institution who will have
access to the Select Agents and procedures for ensuring that only approved and
appropriate individuals, in accordance with institution procedures, will have
access to the Select Agents under the contract; and copies of or links to any
applicable laws, regulations, policies, and procedures applicable to that
institution for the safe and secure possession, use, and/or transfer of select
agents.  No NIH funds can be used for work involving a Select Agent or Toxin at
a foreign institution without written approval from the Contracting Officer.

 

Listings of HHS select agents and toxins, and overlap select agents or toxins as
well as information about the registration process for domestic institutions,
are available on the Select Agent Program Web site at http://www:cdc.gov/od/sap/
and http://www.cdc.gov/od/sap/docs/salist.pdf

 

Listings of USDA select agents and toxins as well as information about the
registration process for domestic institutions are available on the APHIS/USDA
website at:  http://www.aphis_usda.gov/programs/ag_selectagent/index.html and:
http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html

 

For foreign institutions, see the NIAID Select Agent Award information:
( http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm).

 

46

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ARTICLE H.27.  POSSESSION, USE OR TRANSFER OF A HIGHLY PATHOGENIC AGENT

 

The work being conducted under this contract may involve the possession, use, or
transfer of a Highly Pathogenic Infectious Agent (HPA).  The NIAID defines an
HPA as a pathogen that, under any circumstances, warrants a biocontainment
safety level of BSL3 or higher according to either:

 

1.               The current edition of the CDC/NIH Biosafety in Microbiological
and Biomedical Laboratories (BMBL)

(http:// www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm);

 

2.               The Contractor’s Institutional Biosafety Committee (IBC) or
equivalent body; or

 

3.               The Contractor’s appropriate designated institutional biosafety
official.

 

If there is ambiguity in the BMBL guidelines and/or there is disagreement among
the BMBL, an IBC or equivalent body, or institutional biosafety official, the
highest recommended containment level must be used.

 

ARTICLE H.28.  HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

 

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund
in whole or in part a meeting, convention, conference or training seminar that
is conducted in, or that otherwise uses the rooms, facilities, or services of a
place of public accommodation that do not meet the requirements of the fire
prevention and control guidelines as described in the Public Law.  This
restriction applies to public accommodations both foreign and domestic.

 

Public accommodations that meet the requirements can be accessed at: 
http://www.usfa.fema.gov/hotel/index.htm.

 

ARTICLE H.29.  PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

 

The Contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the
provision of resources and support to, individuals and organizations associated
with terrorism.  It is the legal responsibility of the Contractor to ensure
compliance with these Executive Orders and Laws.  This clause must be included
in all subcontracts issued under this contract.

 

ARTICLE H.30.  NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS
RESULTING FROM NIH-FUNDED RESEARCH

 

Beginning April 7, 2008, NIH-funded investigators shall 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 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-08-033.html.

 

47

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PART II - CONTRACT CLAUSES

 

SECTION I - CONTRACT CLAUSES

 

General Clauses for a Cost-Reimbursement Research and Development Contract

 

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.amet.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

 

Sep 2006

 

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

 

Sep 2007

 

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

 

Apr 2008

 

Central Contractor Registration

52.204-10

 

Sep 2007

 

Reporting Subcontract Awards ($500,000,000 or more)

52.209-6

 

Sep 2006

 

Protecting the Government’s Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $30,000)

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 (Over $650,000)

52.215-12

 

Oct 1997

 

Subcontractor Cost or Pricing Data (Over $650,000)

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

 

Apr 2008

 

Small Business Subcontracting Plan (Over $550,000, $1,000 000 for Construction)

 

48

--------------------------------------------------------------------------------

 

FAR

 

 

 

 

CLAUSE NO.

 

DATE

 

TITLE

52.219-16

 

Jan 1999

 

Liquidated Damages - Subcontracting Plan (Over $550,000, $1,000,000 for
Construction)

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

 

Mar 2007

 

Equal Opportunity

52.222-35

 

Sep 2006

 

Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Over $100,000)

52.222-36

 

Jun 1998

 

Affirmative Action for Workers with Disabilities

52.222-37

 

Sep 2006

 

Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Over $100,000)

52.222-50

 

Aug 2007

 

Combating Trafficking in Persons

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

 

Jun 2008

 

Restrictions on Certain Foreign Purchases

52.227-1

 

Dec 2007

 

Authorization and Consent, Alternate I (Apr 1984)

52.227-2

 

Dec 2007

 

Notice and Assistance Regarding Patent and Copyright Infringement

52.227-11

 

Dec 2007

 

Patent Rights - Ownership by the Contractor (Note: In accordance with FAR
27.303(b)(2), paragraph (e) is modified to include the requirements in FAR
27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.

52.227-14

 

Dec 2007

 

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

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 $650,000)

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

 

Jun 2007

 

Subcontracts, Alternate I(June 2007)

52.244-5

 

Dec 1996

 

Competition in Subcontracting (Over $100,000)

52.244-6

 

Mar 2007

 

Subcontracts for Commercial Items

 

49

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FAR

 

 

 

 

CLAUSE NO.

 

DATE

 

TITLE

52.245-1

 

Jun 2007

 

Government Property

52.245-9

 

Jun 2007

 

Use and Charges

52.246-23

 

Feb 1997

 

Limitation of Liability (Over $100,000)

52.249-6

 

May 2004

 

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 2006

 

Definitions - with Alternate paragraph (h) (Jan 2006)

352.216-72

 

Jan 2006

 

Additional Cost Principles

352.228-7

 

Dec 1991

 

Insurance - Liability to Third Persons

352.232-9

 

Jan 2006

 

Withholding of Contract Payments

352.233-70

 

Jan 2006

 

Litigation and Claims

352.242-71

 

Apr 1984

 

Final Decisions on Audit Findings

352.270-5

 

Jan 2006

 

Key Personnel

352.270-6

 

Jan 2006

 

Publications and Publicity

352.270-10

 

Jan 2006

 

Anti-Lobbying (Over S100,000)

 

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT- Rev. 08/2008].

 

50

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ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES

 

ARTICLE I.1. of this SECTION is hereby modified as follows:

 

a.               FAR Clauses 52.215-15, Pension Adjustments And Asset Reversions
(October 2004); 52.215-18, Reversion Or Adjustment Of Plans For Post Retirement
Benefits (PRB) Other Than Pensions (July 2005); and, 52.215-19, Notification Of
Ownership Changes (October 1997), are deleted in their entirety.

 

b.              Alternate IV (October 1997) of FAR Clause 52.215-21,
Requirements For Cost Or Pricing Data Or Information Other Than Cost Or Pricing
Data—Modifications (October 1997) is added.

 

c.               FAR Clauses 52.219-9, Small Business Subcontracting Plan
(April 2008), and 52.219-16, Liquidated Damages—Subcontracting Plan
(January 1999) are deleted in their entirety.

 

d.              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 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.

 

51

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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 52.203-13, Contractor Code of Business Ethics and
Conduct (December 2007).

 

2.               FAR Clause 52.203-14, Display of Hotline
Poster(s) (December 2007).

 

“…..(3) Any required posters may be obtained as follows:

 

Poster(s)

 

Obtain From”

HHS Contractor Code of Ethics and
Business Conduct Poster

 

http://www.oig.hhs.gov/hotline/OIG_Hotline_Poster.pdf

 

3.               FAR Clause 52.215-17, Waiver of Facilities Capital Cost of
Money (October 1997).

 

4.               FAR Clause 52.217-7, Option for Increased Quantity - Separately
Priced Line Item (March 1989).

 

“....The Contracting Officer may exercise the option by written notice to the
Contractor within 60 calendar days .”

 

5.               FAR Clause 52.219-4, Notice of Price Evaluation Preference for
HUBZone Small Business Concerns (July 2005).

 

“(c) Waiver of evaluation preference…..
o Offeror elects to waive the evaluation preference.”

 

6.               FAR Clause 52.222-29, Notification of Visa Denial (June 2003).

 

7.               FAR Clause 52.223-3, Hazardous Material Identification and
Material Safety Data (January 1997), with Alternate I (July 1995).

 

8.               FAR Clause 52.224-1, Privacy Act Notification (April 1984).

 

9.               FAR Clause 52.224-2, Privacy Act (April 1984).

 

10.         Alternate II (December 2007), FAR Clause 52.227-14, Rights in
Data—General (December 2007).

 

Additional purposes for which the limited rights data may be used are:

 

None.

 

52

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11.         Alternate III (December 2007), FAR Clause 52.227-14, Rights in
Data–General (December 2007).

 

Additions to, or limitations on, the restricted rights set forth in the
Restricted Rights Notice of subparagraph (g)(4) of the clause are expressly
stated as follows:  None.

 

12.         Alternate V (December 2007), FAR Clause 52.227-14, Rights in
Data—General (December 2007).

 

Specific data items that are not subject to paragraph (j) include:  None.

 

13.         FAR Clause 52.227-16, Additional Data Requirements (June 1987).

 

14.         FAR Clause 52.227-17, Rights in Data—Special Works (December 2007).

 

15.         FAR Clause 52.227-23, Rights to Proposal Data (Technical)
(June 1987).

 

Excluded pages from the proposal are identified as follows:

 

None.

 

16.         FAR Clause 52.229-8, Taxes-Foreign Cost-Reimbursement Contracts
(March 1990).

 

17.         FAR Clause 52.239-1, Privacy or Security Safeguards (August 1996).

 

18.         FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001).

 

19.         FAR Clause 52.247-63, Preference for U.S. Flag Air Carriers
(June 2003).

 

20.         FAR Clause 52.247-68, Report of Shipment (REPSHIP) (February 2006).

 

B.              DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CHAPTER 3) CLAUSES:

 

1.               HHSAR Clause 352.223-70, Safety and Health (January 2006).

 

2.               HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences
and Seminars to Persons with Disabilities (January 2001).

 

3.               HHSAR Clause 352.270-7, Paperwork Reduction Act (January 2006).

 

4.               HHSAR Clause 352.270-8(b), Protection of Human Subjects
(January 2006).

 

5.               HHSAR Clause 352.270-9(b), Care of Live Vertebrate Animals
(January 2006).

 

6.               HHSAR Clause 352.333-7001, Choice of Law (Overseas)
(March 2005).

 

53

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C.               NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC)
CLAUSES:

 

The following clauses are attached and made a part of this contract:

 

1.               NIH (RC)-7, PROCUREMENT OF CERTAIN EQUIPMENT (APRIL 1984).

 

2.               NIH(RC)-11, RESEARCH PATIENT CARE COSTS (4/1/84).

 

54

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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:

 

a.               FAR Clause 52.219-28, Post-Award Small Business Program
Representation (June 2007).

 

(a) Definitions.  As used in this clause—

 

Long-term contract means a contract of more than five years in duration,
including options.  However, the term does not include contracts that exceed
five years in duration because the period of performance has been extended for a
cumulative period not to exceed six months under the clause at 52.217-8, Option
to Extend Services, or other appropriate authority.

 

Small business concern means a concern, including its affiliates, that is
independently owned and operated, not dominant in the field of operation in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of
this clause.

 

(b) If the Contractor represented that it was a small business concern prior to
award of this contract, the Contractor shall rerepresent its size status
according to paragraph (e) of this clause or, if applicable, paragraph (g) of
this clause, upon the occurrence of any of the following:

 

(1) Within 30 days after execution of a novation agreement or within 30 days
after modification of the contract to include this clause, if the novation
agreement was executed prior to inclusion of this clause in the contract.

 

(2) Within 30 days after a merger or acquisition that does not require a
novation or within 30 days after modification of the contract to include this
clause, if the merger or acquisition occurred prior to inclusion of this clause
in the contract.

 

(3) For long-term contracts

 

(i) Within 60 to 120 days prior to the end of the fifth year of the contract;
and

 

(ii) Within 60 to 120 days prior to the exercise date specified in the contract
for any option thereafter.

 

(c) The Contractor shall rerepresent its size status in accordance with the size
standard in effect at the time of this rerepresentation that corresponds to the
North American Industry Classification System (NAICS) code assigned to this
contract.  The small business size standard corresponding to this NAICS code can
be found at
http://www.sba.gov/services/contractingopportunities/sizestandardstopics/.

 

(d) The small business size standard for a Contractor providing a product which
it does not manufacture itself, for a contract other than a construction or
service contract, is 500 employees.

 

(e) Except as provided in paragraph (g) of this clause, the Contractor shall
make the rerepresentation required by paragraph (b) of this clause by validating
or updating all its representations in the Online Representations and
Certifications Application and its data in the Central Contractor Registration,
as necessary, to ensure they reflect current status.  The Contractor shall
notify the contracting office by e-mail, or otherwise in writing, that the data
have been validated or updated, and provide the date of the validation or
update.

 

(f) If the Contractor represented that it was other than a small business
concern prior to award of this contract, the Contractor may, but is not required
to, take the actions required by paragraphs (e) or (g) of this clause.

 

(g) If the Contractor does not have representations and certifications in ORCA,
or does not have a representation in ORCA for the NAICS code applicable to this
contract, the Contractor is required to complete

 

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the following rerepresentation and submit it to the contracting office, along
with the contract number and the date on which the rerepresentation was
completed:

 

The Contractor represents that it is a small business concern under NAICS Code
assigned to contract number.  (End of clause)

 

B.              FAR CLAUSE 52.222-39, NOTIFICATION OF EMPLOYEE RIGHTS CONCERNING
PAYMENT OF UNION DUES OR FEES (DECEMBER 2004)

 

(a) Definition.  As used in this clause—

 

United States means the 50 States, the District of Columbia, Puerto Rico, the
Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and
Wake Island.

 

(b) Except as provided in paragraph (e) of this clause, during the term of this
contract, the Contractor shall post a notice, in the form of a poster, informing
employees of their rights concerning union membership and payment of union dues
and fees, in conspicuous places in and about all its plants and offices,
including all places where notices to employees are customarily posted.  The
notice shall include the following information (except that the information
pertaining to National Labor Relations Board shall not be included in notices
posted in the plants or offices of carriers subject to the Railway Labor Act, as
amended (45 U.S.C. 151-188)).

 

Notice to Employees

 

Under Federal law, employees cannot be required to join a union or maintain
membership in a union in order to retain their jobs.  Under certain conditions,
the law permits a union and an employer to enter into a union-security agreement
requiring employees to pay uniform periodic dues and initiation fees.  However,
employees who are not union members can object to the use of their payments for
certain purposes and can only be required to pay their share of union costs
relating to collective bargaining, contract administration, and grievance
adjustment.

 

If you do not want to pay that portion of dues or fees used to support
activities not related to collective bargaining, contract administration, or
grievance adjustment, you are entitled to an appropriate reduction in your
payment.  If you believe that you have been required to pay dues or fees used in
part to support activities not related to collective bargaining, contract
administration, or grievance adjustment, you may be entitled to a refund and to
an appropriate reduction in future payments.

 

For further information concerning your rights, you may wish to contact the
National Labor Relations Board (NLRB) either at one of its Regional offices or
at the following address or toll free number:

 

National Labor Relations Board
Division of Information
1099 14th Street, N.W.
Washington, DC 20570
1-866-667-6572
1-866-316-6572 (TTY)

 

To locate the nearest NLRB office, see NLRB’s website at http://www.nlrb gov.

 

(c) The Contractor shall comply with all provisions of Executive Order 13201 of
February 17, 2001, and related implementing regulations at 29 CFR part 470, and
orders of the Secretary of Labor.

 

(d) In the event that the Contractor does not comply with any of the
requirements set forth in paragraphs (b), (c), or (g), the Secretary may direct
that this contract be cancelled, terminated, or suspended in whole or in part,
and declare the Contractor ineligible for further Government contracts in
accordance with procedures at 29 CFR part 470, Subpart B—Compliance Evaluations,
Complaint Investigations and Enforcement Procedures.  Such other sanctions or
remedies may be imposed

 

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as are provided by 29 CFR part 470, which implements Executive Order 13201, or
as are otherwise provided by law.

 

(e) The requirement to post the employee notice in paragraph (b) does not apply
to—

 

(1) Contractors and subcontractors that employ fewer than 15 persons;

 

(2) Contractor establishments or construction work sites where no union has been
formally recognized by the Contractor or certified as the exclusive bargaining
representative of the Contractor’s employees;

 

(3) Contractor establishments or construction work sites located in a
jurisdiction named in the definition of the United States in which the law of
that jurisdiction forbids enforcement of union-security agreements;

 

(4) Contractor facilities where upon the written request of the Contractor, the
Department of Labor Deputy Assistant Secretary for Labor-Management Programs has
waived the posting requirements with respect to any of the Contractor’s
facilities if the Deputy Assistant Secretary finds that the Contractor has
demonstrated that—

 

(i) The facility is in all respects separate and distinct from activities of the
Contractor related to the performance of a contract; and

 

(ii) Such a waiver will not interfere with or impede the effectuation of the
Executive order; or

 

(5) Work outside the United States that does not involve the recruitment or
employment of workers within the United States.

 

(f) The Department of Labor publishes the official employee notice in two
variations; one for contractors covered by the Railway Labor Act and a second
for all other contractors.  The Contractor shall—

 

(1) Obtain the required employee notice poster from the Division of
Interpretations and Standards, Office of Labor-Management Standards, U.S.
Department of Labor, 200 Constitution Avenue, NW, Room N-5605, Washington, DC
2021, or from any field office of the Department’s Office of Labor-Management
Standards or Office of Federal Contract Compliance Programs;

 

(2) Download a copy of the poster from the Office of Labor-Management Standards
website at http://www.olms.dol.gov; or

 

(3) Reproduce and use exact duplicate copies of the Department of Labor’s
official poster.

 

(g) The Contractor shall include the substance of this clause in every
subcontract or purchase order that exceeds the simplified acquisition threshold,
entered into in connection with this contract, unless exempted by the Department
of Labor Deputy Assistant Secretary for Labor-Management Programs on account of
special circumstances in the national interest under authority of 29 CFR
470.3(c).  For indefinite quantity subcontracts, the Contractor shall include
the substance of this clause if the value of orders in any calendar year of the
subcontract is expected to exceed the simplified acquisition threshold. 
Pursuant to 29 CFR part 470, Subpart B—Compliance Evaluations, Complaint
Investigations and Enforcement Procedures, the Secretary of Labor may direct the
Contractor to take such action in the enforcement of these regulations,
including the imposition of sanctions for noncompliance with respect to any such
subcontract or purchase order.  If the Contractor becomes involved in litigation
with a subcontractor or vendor, or is threatened with such involvement, as a
result of such direction, the Contractor may request the United States, through
the Secretary of Labor, to enter into such litigation to protect the interests
of the United States

 

(End of Clause)

 

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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

SECTION J - LIST OF ATTACHMENTS

 

The following documents are attached and incorporated in this contract:

 

1.  Statement of Work

 

Statement of Work, dated September 25, 2008, 17 pages.

 

2.  Invoice/Financing Request and Contract Financial Reporting Instructions for
NIH Cost-Reimbursement Type Contracts, NIH(RC)-4

 

Invoice/Financing Request and Contract Financial Reporting Instructions for NIH
Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/07), 6 pages.

 

3.  Inclusion Enrollment Report

 

Inclusion Enrollment Report, 5/01 (Modified OAMP:  10/01), 1 page.

 

4.  Annual Technical Progress Report Format for Each Study

 

Annual Technical Progress Report Format for Each Study, July 1994, 1 page.

 

5.  Safety and Health

 

Safety and Health, HHSAR Clause 352.223-70, (1/06), 1 page.

 

6.  Procurement of Certain Equipment

 

Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.

 

7.  Research Patient Care Costs

 

Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.

 

8.  Disclosure of Lobbying Activities, SF-LLL

 

Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages.

 

9.  Commitment To Protect Non-Public Information

 

Commitment To Protect Non-Public Information, 1 page.  Located at: 
http://irm.cit.nih.gov/security/Nondisclosure.pdf

 

10.  Roster of Employees Requiring Suitability Investigations

 

Roster of Employees Requiring Suitability Investigations, 1 page.  Excel file
located at:

http://ais.nci.nih.gov/forms/Suitability-roster.xls

 

11.  Employee Separation Checklist

 

Employee Separation Checklist, 1 page.  Fillable PDF format located at: 

http://rcb.cancer.gov/rcb-internet/forms/Emp-sep-checklist.pdf

 

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PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

 

The following documents are incorporated by reference in this contract:

 

1.               Annual Representations and Certifications completed and located
at the Online Representations and Certifications Application (ORCA) website. 
This includes the changes identified in paragraph (b) of the FAR provision
52.204-8, Annual Representations and Certifications, contained in the
Contractor’s proposal.

 

2.               Representations and Certifications, dated August 26, 2008.

 

3.               Human Subjects Assurance Identification Number FWA00010447.

 

4.               Animal Welfare Assurance Number A3034-01.

 

END of the SCHEDULE

 

(CONTRACT)

 

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STATEMENT OF WORK

 

“Biodefense Vaccine Enhancement - Development of a Third
Generation rPA Anthrax Vaccine”

 

BACKGROUND

 

Research supported and conducted by the National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of
Health and Human Services, strives to understand, treat and ultimately prevent
the myriad infectious, immunologic, and allergic diseases that threaten millions
of human lives.  The NIAID Division of Microbiology and Infectious Diseases
(DMID) supports extramural research to control and prevent diseases caused by
virtually all infectious agents, with the exception of the human
immunodeficiency virus (HIV).  This includes basic and applied research to
develop and evaluate therapeutics, vaccines, and diagnostics, which are funded
through a variety of research grants and contracts.  The NIAID is also the
primary institute at the NIH for emerging infectious disease research, including
research on pathogens that can be used as agents of bioterrorism.  Bioterrorism
is defined as the use of microorganisms or the toxins produced by microorganisms
to harm people or to elicit widespread fear and intimidation of society.  Recent
events have significantly changed the world’s perception of the nature and
degree of the threats posed by the use of infectious agents as weapons of
bioterrorism.  The risk of using such weapons once appeared to be restricted to
military encounters.  However, in October of 2001, the exposure of postal
workers, other government employees, and U.S. civilians at large to Bacillus
anthracis spores highlighted the need to devise safe and effective measures to
protect all U.S. citizens from the debilitating and lethal effects of agents of
bioterrorism.  The NIAID supports a number of basic and applied research efforts
to develop countermeasures for microbes identified by the NIAID biodefense
research agenda as Category A, B and C Priority Pathogens
http://www.niaid.nih.gov/Biodefense/bandc_priority.htm.

 

On December 19, 2006, President George W. Bush signed into law the Pandemic and
All-Hazards Preparedness Act (Public Law 109-417), referred to as PAHPA.  Title
IV of PAHPA established the Biomedical Advanced Research and Development
Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and
Response (ASPR) in the U.S. Department of Health and Human Services (HHS) to
facilitate the research, development, and acquisition of medical countermeasures
for chemical, biological, radiological, and nuclear (CBRN) agents and emerging
infectious diseases, including pandemic influenza, that threaten the U.S.
civilian population.  One of the central responsibilities of BARDA is to lead
the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE),
which provides an integrated approach to the development and purchase of medical
countermeasures for public health medical emergencies.  The HHS PHEMCE consists
of NIH, ASPR, the U.S. Food and Drug Administration (FDA), and Centers for
Disease Control and Prevention (CDC), along with ex officio participation from
other federal agencies.  To guide progress toward the goal of public health
preparedness, the HHS PHEMCE Implementation Plan provides insight into the
current priorities for medical countermeasure development.

 

BARDA, in partnership with the NIAID on this contract, is working through
advanced product development activities supported under this contract that will
contribute towards allowing candidate medical countermeasures to progress
through the development pipeline toward licensure.  The eventual goal is to
enable the U.S. Government to stockpile these medical countermeasures to protect
the American public.  Product

 

HHSN272200800049C

 

Attachment 1

Statement of Work

 

 

September 25, 2008

 

 

 

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developers should be cognizant of the logistical implications of using these
products during a public health emergency.

 

For additional information on BARDA, the PHEMCE Implementation Plan, and Project
BioShield, please visit http://www.hhs.gov/aspr/barda.

 

SCOPE

 

The objective of this contract is to develop an anthrax vaccine containing rPA
and CpG immunostimulant.  The scope of work includes demonstrating stability of
the candidate vaccine and diluent at 35 degrees C over the duration of the base
period; safety prior to human use through acute dose and repeat dose toxicology
testing in 2 animal species; improved vaccine efficacy over existing vaccines
through non-clinical aerosol challenge studies in the pre-existing rabbit and
macaque models, plus supporting studies in the mouse models.  Options exist for
a Phase I and Phase II clinical trial.

 

TECHNICAL REQUIREMENTS BY MILESTONE

 

Independently, and not as an agent of the Government, the Contractor shall
furnish all necessary services, qualified professional, technical, and
administrative personnel, material, equipment and facilities, not otherwise
provided by the Government under the terms of the contract, as needed to perform
the Statement of Work.

 

The U.S. Government reserves the right to determine, at any time during the
contract period, that a particular candidate/product has not demonstrated
sufficient potential to merit further investment in the development and
evaluation of that candidate/product.  In addition, the U.S. Government reserves
the right to modify the milestones, progress, schedule, budget, or product to
add or delete products, process, or schedule as need may arise.  Because of the
nature of this Research and Development (R&D) contract and complexities inherent
in this and prior programs, at designated milestones the Government will
evaluate whether work should be redirected, removed, or whether schedule or
budget adjustments should be made.  In any event, the Government reserves the
right to change product, process, schedule, or event to add or delete part or
all of these elements as the needs arise.

 

The Contractor shall attend the following contract meetings:

 

·                  Post-Award Contract Initiation Meeting:  Within thirty (30)
calendar days after the effective date of the contract, the Contractor shall
plan, conduct and be responsible for the logistical arrangements for a 1.5-day
Post-award Contract Initiation Meeting to be held in the Bethesda, Maryland
area.

 

·                  Annual Review Meetings:  The Contractor, in consultation with
the Project Officer, shall plan, organize and conduct 2-day Annual Review
Meetings to be held at the twelve (12) month mark of each contract year at
locations that will alternate between the Contractor’s site and the Bethesda,
Maryland area.  These meetings shall include updates of the status of efforts
for each milestone since the prior meeting, a description of any problem(s) that
may have arisen and actions taken or recommended to resolve identified problems,
and a discussion of future plans for each milestone.

 

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·                  Additional Contract Meetings:  Principal Investigator,
Project Manager, and Contractor and subcontractor personnel shall attend at
least two additional 1-day meetings per year at locations that will alternate
between the Contractor’s site and the Bethesda, Maryland area at the request of
the Project Officer, as necessary, to discuss contract specific issues and to
review recommended changes or deviations from milestones and timelines in the
approved Product Development Plan.

 

BASE PERIOD - Process Development and Feasibility

 

1.0       Manufacture of cGMP FDP (lyo-rPA/CpG) and diluent (Milestone 1)

 

Within 28 months, complete the release of >2,000 doses of both cGMP FDP (lyo
rPA/CpG) and diluent, suitable for use in Phase I clinical trials.  Work shall
include the following activities and deliverables:

 

a.               Process Development

 

·                  Generation of R&D FDP (lyo rPA/CpG) and diluent for
analytical development and preliminary stability studies

·                  Production of development lots

·                  Production of initial reference standard

·                  Development of the process steps to produce the bulk FDP (lyo
rPA/CpG)

·                  Formulation and its subsequent aliquoting into vials prior to
lyophilization.

·                  Development of the Iyophilization cycle suitable for
manufacturing to the required scale.

·                  A final report shall be provided to the Project Officer,
which shall describe the development activities undertaken, data generated and
recommendations for technical transfer and scale up of the process.

 

b.              Technical Transfer of process to FDP (lyo rPA/CpG) manufacturer

 

·                  Review audit status, quality agreement and commercial
contract.  Re-audit, update the quality agreement and contract as required.

·                  Submit copy of current audit report and quality agreement to
the Project Officer for consent prior to placing orders with CMO.

·                  Transfer of the lyophilization process to the cGMP facility -
CMO.

·                  Establishment and qualification of the required analytical
methods at CMO and/or other selected CROs.

·                  Technical transfer reports summarizing completion of
activities shall be submitted to the Project Officer, including analytical
qualification reports, prior to GMP manufacture.

 

c.               Production of Master Batch Records (MBRs)

 

·                  Master batch records shall be produced by CMO and reviewed
and approved by the Contractor’s technical and quality functions and by CMO

·                  Final approved MBRs shall be submitted to the Project Officer
prior to production of the demonstration batches

 

d.              Production of two demonstration batches of FDP (lyo rPA/CpG)

 

·                  Conduct cGMP manufacturing runs

·                  Complete release testing of material

·                  Complete QA review of batch records, including review of
non-conformances and disposition of batch

 

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e.               Update of Master Batch Records (MBRs)

 

·                  Updated Master batch records shall be produced by CMO and
reviewed and approved by the Contractor’s technical and quality functions and by
CMO

 

f.                 Production of two clinical batches of cGMP FDP (lyo rPA/CpG)

 

·                  Conduct two cGMP manufacturing runs

·                  Complete release testing of materials

·                  Complete QA review of batch records, including review of
non-conformances and disposition of batch

·                  Submit copies of the executed BMRs and CoA to Project
Officer, within 5 months after manufacture.

 

g.              Clinical batch of cGMP diluent (to be supplied from the
Challenge Grant program)

 

·                  Conduct a cGMP manufacturing run

·                  Complete release testing of diluent

·                  Complete QA review of batch records, including review of
non-conformances and disposition of batch

·                  This work shall be supplied from the existing challenge grant

 

2.0       Development and Qualification of Assays (Milestone 2)

 

Develop and qualify all assays required for manufacture, stability, non-clinical
and clinical.  Work shall include the following activities and deliverables:

 

a.               Analytical Development and qualification of Process Assays

 

·                  Development and qualification of in-process monitoring and
control assays

·                  Qualification reports shall be produced and submitted to the
Project Officer within 14 months of award.

 

b.              Analytical Development and qualification of Product Assays

 

·                  Development and qualification of product characterization and
release assays

·                  Qualification reports shall be produced and submitted to the
Project Officer within 14 months of award.

 

c.               Analytical Development and qualification of Stability
Indicating Assays

 

·                  Development and qualification of stability indicating assays

·                  Qualification reports shall be produced and submitted to the
Project Officer within 14 months of award.

 

d.              Development of immuno-potency assay in association with on-going
rPA vaccine programme.

 

·                  Development of immuno-potency assay

·                  Development reports shall be produced and submitted to the
Project Officer within 24 months of award.

 

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3.0       Stability (Milestone 3)

 

Initiate R&D and cGMP stability trials within 11 months and 26 months
respectively of contract award.  Work shall include the following activities and
deliverables:

 

a)              Set up R&D and cGMP stability trials

 

R&D Stability Trials

 

·                  Produce R&D protocol(s) for FDP (Iyo-rPA/CpG) and diluent
stability trials

·                  Initiate the R&D stability trial using the non-GMP FDP (lyo
rPA/CpG) and diluent material

 

cGMP Stability Trials

 

·                  Review audit status, quality agreement and commercial
contract.  Re-audit, update the quality agreement and contract as required.

·                  Submit copy of current audit report and quality agreement to
Project Officer prior to placing orders with CRO

·                  Produce cGMP protocol(s) for FDP (lyo rPA/CpG) and diluent
stability trials

·                  Technical and quality review and approval of protocols

·                  Initiate stability trial using the cGMP FDP (lyo rPA/CpG) lot
and diluent.  The stability program shall include real-time and accelerated
studies using temperatures of 35 ° C (proposal required temperature) and 55 ° C
(accelerated condition).

·                  cGMP stability protocols shall be submitted to the Project
Officer at least 1 month prior to initiation of the study.

·                  Updated stability data shall be submitted to the Project
Officer as part of the Monthly report.

·                  An end of stability study report shall be submitted to the
Project Officer

 

4.0       Pre-Clinical Toxicology (Milestone 4)

 

Within 12 months of contract award, commence a Good Laboratory Practice (GLP)
safety and toxicity study(ies).  Work shall include the following activities and
deliverables:

 

a.               Confirmation of CRO and Generation of study protocols

 

·                  Review audit status, quality agreement and commercial
contract.  Re-audit, update the quality agreement and contract as required.

·                  Production of a draft safety and toxicity protocol(s)

·                  Submit for Project Officer review a draft safety and toxicity
protocol(s) (WBS 4.1.2)

·                  Submit copy of current audit report and quality agreement to
Project Officer prior to placing orders with CRO.

 

b.              Conduct Acute Dose Safety and Toxicity Studies

 

·                  Finalize set-up with CRO (including supply of materials and
animals)

·                  Complete acute dose toxicity studies

·                  Technical and quality review and approval of reports

·                  Submit reports to Project Officer.

 

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c.               Conduct Repeat Dose Safety and Toxicity Studies

 

·                  Finalize set-up with CRO (including supply of materials and
animals)

·                  Complete repeat dose toxicity studies

·                  Technical and quality review and approval of reports

·                  Submit reports to Project Officer.

 

d.              Conduct Safety Pharmacology study

 

·                  Finalize set-up with CRO (including supply of materials and
animals)

·                  Complete safety pharmacology study

·                  Technical and quality review of report

·                  Submit report to Project Officer.

 

e.               Submission of final reports to CBER

 

·                  Submit Acute Dose report to CBER and seek concurrence

·                  Submit Repeat Dose report to CBER and seek concurrence

·                  Submit Safety Pharmacology report to CBER and seek
concurrence

·                  Provide documentation to the Project Officer of interactions
with the FDA and that concurrence has been received from CBER/FDA.

 

5.0       Non-Clinical Development Mouse Model - (Milestone 5)

 

Within 8 month of contract award, commence studies in the mouse model.  Prior to
the initiation of these studies, confirmation of the CRO shall be undertaken.

 

Upon CRO confirmation the following studies shall be undertaken;

 

i.                  Excipient Effects

ii.               Immunogenicity studies

iii.            Dose Ranging (CpG/rPA ratios)

iv.           Adjuvant Requirements

 

Each of the above studies shall include the following activities and
deliverables:

 

a.               Animal Studies Group (ASG) Consultation

 

·                  Submission of a draft protocol(s) to ASG and NIH

·                  Finalize protocol incorporating any comments from ASG

·                  Provide documentation to the Project Officer in the form of
written minutes of interactions with the ASG and that concurrence has been
received from ASG.

 

b.              Conduct Studies (i to iv) and Reporting

 

·                  Finalize set-up with CRO (including supply of materials and
animals)

·                  Complete studies

·                  Technical and quality review and approval of report(s)

·                  Submit report(s) to Project Officer

·                  Circulate report(s) to ASG

 

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INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS FOR NIH
COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4

 

Format:  Payment requests shall be submitted on the Contractor’s self-generated
form in the manner and format prescribed herein and as illustrated in the Sample
Invoice/Financing Request.  Standard Form 1034, Public Voucher for Purchases and
Services Other Than Personal, may be used in lieu of the Contractor’s
self-generated form provided it contains all of the information shown on the
Sample Invoice/Financing Request.  DO NOT include a cover letter with the
payment request.

 

Number of Copies:  Payment requests shall be submitted in the quantity specified
in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

Frequency:  Payment requests shall not be submitted more frequently than once
every two weeks in accordance with the Allowable Cost and Payment Clause
incorporated into this contract.  Small business concerns may submit
invoices/financing requests more frequently than every two weeks when authorized
by the Contracting Officer.

 

Cost Incurrence Period:  Costs incurred must be within the contract performance
period or covered by precontract cost provisions.

 

Billing of Costs Incurred:  If billed costs include (1) costs of a prior billing
period, but not previously billed, or (2) costs incurred during the contract
period and claimed after the contract period has expired, the Contractor shall
site the amount(s) and month(s) in which it incurred such costs.

 

Contractor’s Fiscal Year:  Payment requests shall be prepared in such a manner
that the Government can identify costs claimed with the Contractor’s fiscal
year.

 

Currency:  All NIH contracts are expressed in United States dollars.  When the
Government pays in a currency other than United States dollars, billings shall
be expressed, and payment by the Government shall be made, in that other
currency at amounts coincident with actual costs incurred.  Currency
fluctuations may not be a basis of gain or loss to the Contractor. 
Notwithstanding the above, the total of all invoices paid under this contract
may not exceed the United States dollars authorized.

 

Costs Requiring Prior Approval:  Costs requiring the Contracting Officer’s
approval, which are not set forth in an Advance Understanding in the contract,
shall be identified and reference the Contracting Officer’s Authorization (COA)
Number.  In addition, the Contractor shall show any cost set forth in an Advance
Understanding as a separate line item on the payment request.

 

Invoice/Financing Request Identification:  Each payment request shall be
identified as either:

 

(a)          Interim Invoice/Contract Financing Request:  These are interim
payment requests submitted during the contract performance period.

 

(b)          Completion Invoice:  The completion invoice shall be submitted
promptly upon completion of the work, but no later than one year from the
contract completion date, or within 120 days after settlement of the final
indirect cost rates covering the year in which the contract is physically
complete (whichever date is later).  The Contractor shall submit the completion
invoice when all costs have been assigned to the contract and it completes all
performance provisions.

 

(c)          Final Invoice:  A final invoice may be required after the amounts
owed have been settled between the Government and the Contractor (e.g.,
resolution of all suspensions and audit exceptions).

 

Preparation and Itemization of the Invoice/Financing Request:  The Contractor
shall furnish the information set forth in the instructions below.  The
instructions are keyed to the entries on the Sample Invoice/Financing Request. 
All information must be legible or the invoice will be considered improper and
returned to the Contractor.

 

(a)          Designated Billing Office Name and Address:  Enter the designated
billing office name and address, as identified in the Invoice Submission
Instructions in Section G of the Contract Schedule.

 

(b)          Contractor’s Name, Address, Point of Contact, TIN, and DUNS or
DUNS+4 Number.  Show the Contractor’s name and address exactly as they appear in
the contract, along with the name, title, phone number, and e-mail address of
the person to notify in the event of an improper invoice or, in the case of
payment by method other than Electronic Funds Transfer, to whom payment is to be
sent.  If the remittance name differs from the legal business name, both names
must appear on the invoice.  Provide the Contractor’s Federal Taxpayer
Identification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4
number.  The DUNS number must

 

NIH(RC)-4

 

ATTACHMENT 2

Rev. 08/2008

 

 

 

1

--------------------------------------------------------------------------------

 

identify the Contractor’s name and address exactly as stated in the contract,
and as registered in the Central Contractor Registration (CCR) database.  If the
Contractor does not have a valid TIN or DUNS number, provide the Contractor’s
Vendor Identification Number (VIN), which appears after the Contractor’s name on
the face page of the award document.  [Note:  A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include
the VIN number.]  When an approved assignment of claims has been executed, the
Contractor shall provide the same information for the assignee as is required
for the Contractor (i.e., name, address, point of contact, TIN, and DUNS
number), with the remittance information clearly identified as such.

 

(c)          Invoice/Financing Request Number:  Each payment request must be
identified by a unique invoice number, which can only be used one time
regardless of the number of contracts or orders held by an organization.  For
example, if a contractor has already submitted invoice number 05 on one of its
contracts or orders, it cannot use that same invoice number on any other
contract or order.  Payment requests with duplicate invoice numbers will be
considered improper and will be returned to the contractor.

 

The NIH does not prescribe a particular numbering format but suggests using a
job or account number for each contract and order followed by a sequential
invoice number (example:  8675309-05).  Invoice numbers are limited to 30
characters.  There are no restrictions on the use of special characters, such as
colons, dashes, forward slashes, or parentheses.

 

If all or part of an invoice is suspended and the contractor chooses to reclaim
those costs on a supplemental invoice, the contractor may use the same unique
invoice number followed by an alpha character, such as “R” for revised
(example:  8675309-05R).

 

(d)          Date Invoice/Financing Request Prepared:  Insert the date the
payment request is prepared.

 

(e)          Contract Number and Order Number (if applicable):  Insert the
contract number and order number (if applicable).

 

(f)            Effective Date:  Insert the effective date of the contract or if
billing under an order, the effective date of the order.

 

(g)         Total Estimated Cost of Contract/Order:  Insert the total estimated
cost of the contract, exclusive of fixed-fee.  If billing under an order, insert
the total estimated cost of the order, exclusive of fixed-fee.  For
incrementally funded contracts/orders, enter the amount currently obligated and
available for payment.

 

(h)         Total Fixed-Fee:  Insert the total fixed-fee (where applicable). 
For incrementally funded contracts/orders, enter the amount currently obligated
and available for payment.

 

(i)            Two-Way/Three-Way Match:  Identify whether payment is to be made
using a two-way or three-way match.  To determine required payment method, refer
to the Invoice Submission Instructions in Section G of the Contract Schedule

 

(j)            Office of Acquisitions:  Insert the name of the Office of
Acquisitions, as identified in the Invoice Submission Instructions in Section G
of the Contract Schedule.

 

(k)        Central Point of Distribution:  Insert the Central Point of
Distribution, as identified in the Invoice Submission Instructions in Section G
of the Contract Schedule.

 

(I)            Billing Period:  Insert the beginning and ending dates (month,
day, and year) of the period in which costs were incurred and for which
reimbursement is claimed.

 

(m)      Amount Billed - Current Period:  Insert the amount claimed for the
current billing period by major cost element, including any adjustments and
fixed-fee.  If the Contract Schedule contains separately priced line items,
identify the contract line item(s) on the payment request and include a separate
breakdown (by major cost element) for each line item.

 

(n)         Amount Billed - Cumulative:  Insert the cumulative amounts claimed
by major cost element, including any adjustments and fixed-fee.  If the Contract
Schedule contains separately priced line items, identify the contract line
item(s) on the payment request and include a separate breakdown (by major cost
element) for each line item.

 

(o)          Direct Costs:  Insert the major cost elements.  For each element,
consider the application of the paragraph entitled “Costs Requiring Prior
Approval” on page 1 of these instructions.

 

2

--------------------------------------------------------------------------------

 

1)              Direct Labor:  Include salaries and wages paid (or accrued) for
direct performance of the contract.

 

For Level of Effort contracts only, the Contractor shall provide the following
information on a separate sheet of paper attached to the payment request:

 

·                  hours or percentage of effort and cost by labor category (as
specified in the Level of Effort Article in Section F of the contract) for the
current billing period, and

 

·                  hours or percentage of effort and cost by labor category from
contract inception through the current billing period.  (NOTE:  The Contracting
Officer may require the Contractor to provide additional breakdown for direct
labor, such as position title, employee name, and salary or hourly rate.)

 

2)              Fringe Benefits:  List any fringe benefits applicable to direct
labor and billed as a direct cost.  Cite the rate(s) used to calculate fringe
benefit costs, if applicable.

 

3)              Accountable Personal Property:  Include permanent research
equipment and general purpose equipment having a unit acquisition cost of $1,000
or more, with a life expectancy of more than two years, and sensitive property
regardless of cost (see the HHS Contractor’s Guide for Control of Government
Property).  Show permanent research equipment separate from general purpose
equipment.

 

On a separate sheet of paper attached to the payment request, list each item for
which reimbursement is requested.  An asterisk (*) shall precede the item if the
equipment is below the $1,000 approval level.  Include reference to the
following (as applicable):

 

·                  item number for the specific piece of equipment listed in the
Property Schedule, and

·                  COA number, if the equipment is not covered by the Property
Schedule.

 

The Contracting Officer may require the Contractor to provide further
itemization of property having specific limitations set forth in the contract.

 

4)              Materials and Supplies:  Include equipment with unit costs of
less than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.

 

5)              Premium Pay:  List remuneration in excess of the basic hourly
rate.

 

6)              Consultant Fee:  List fees paid to consultants.  Identify
consultant by name or category as set forth in the contract or COA, as well as
the effort (i.e., number of hours, days, etc.) and rate billed.

 

7)              Travel:  Include domestic and foreign travel.  Foreign travel is
travel outside of Canada, the United States and its territories and
possessions.  However, for an organization located outside Canada, the United
States and its territories and possessions, foreign travel means travel outside
that country.  Foreign travel must be billed separately from domestic travel.

 

8)              Subcontract Costs:  List subcontractor(s) by name and amount
billed.

 

9)              Other:  List all other direct costs in total unless exceeding
$1,000 in amount.  If over $1,000, list cost elements and dollar amounts
separately.  If the contract contains restrictions on any cost element, that
cost element must be listed separately.

 

(p)          Cost of Money (COM):  Cite the COM factor and base in effect during
the time the cost was incurred and for which reimbursement is claimed.

 

(q)          Indirect Costs:  Identify the indirect cost base (IDC), indirect
cost rate, and amount billed for each indirect cost category.

 

(r)          Fixed-Fee:  Cite the formula or method of computation for
fixed-fee, if applicable.  The fixed-fee must be claimed as provided for by the
contract.

 

(s)          Total Amounts Claimed:  Insert the total amounts claimed for the
current and cumulative periods.

 

(t)            Adjustments:  Include amounts conceded by the Contractor,
outstanding suspensions, and/or disapprovals subject to appeal

 

(u)         Grand Totals

 

3

--------------------------------------------------------------------------------

 

(v)           Certification of Salary Rate Limitation:  If required by the
contract (see Invoice Submission Instructions in Section G of the Contract
Schedule), the Contractor shall include the following certification at the
bottom of the payment request:

 

“I hereby certify that the salaries billed in this payment request are in
compliance with the Salary Rate Limitation Provisions in Section H of the
contract.”

 

The Contracting Officer may require the Contractor to submit detailed support
for costs claimed on one or more interim payment requests.

 

4

--------------------------------------------------------------------------------

 

FINANCIAL REPORTING INSTRUCTIONS:

 

These instructions are keyed to the Columns on the sample invoice/financing
request.

 

Column A - Expenditure Category:  Enter the expenditure categories required by
the contract.

 

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated:  Enter the
percentage of effort or number of hours agreed to for each employee or labor
category listed in Column A.

 

Column C - Cumulative Percentage of Effort/Hrs. - Actual:  Enter the percentage
of effort or number of hours worked by each employee or labor category listed in
Column A.

 

Column D - Amount Billed - Current:  Enter amounts billed during the current
period.

 

Column E - Amount Billed - Cumulative:  Enter the cumulative amounts to date.

 

Column F - Cost at Completion:  Enter data only when the Contractor estimates
that a particular expenditure category will vary from the amount negotiated. 
Realistic estimates are essential.

 

Column G - Contract Amount:  Enter the costs agreed to for all expenditure
categories listed in Column A.

 

Column H - Variance (Over or Under):  Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F.  This column need not be filled in when Column F is
blank.  When a line item varies by plus or minus 10 percent, i.e., the
percentage arrived at by dividing Column F by Column G, an explanation of the
variance should be submitted.  In the case of an overrun (net negative
variance), this submission shall not be deemed as notice under the Limitation of
Cost (Funds) Clause of the contract.

 

Modifications:  Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.

 

Expenditures Not Negotiated:  An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the Contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G.  Column H will of course show a 100 percent variance
and will be explained along with those identified under H above.

 

5

--------------------------------------------------------------------------------

 

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

(a)          Designated Billing Office Name and Address:

 

National Institutes of Health

Office of Financial Management

Commercial Accounts

2115 East Jefferson Street, Room 4B432, MSC 8500

Bethesda, MD 20892-8500

 

(b)         Contractor’s Name, Address, Point of Contact, TIN, and

DUNS or DUNS+4 Number.

 

ABC CORPORATION

100 Main Street

Anywhere, U.S.A. Zip+4

 

Name, Title, Phone Number, and E-mail Address of person to notify in the event
of an improper invoice or, in the case of payment by method other than
Electronic Funds Transfer, to whom payment is to be sent.

 

*DUNS or DUNS+4:                                                             
*TIN:

 

--------------------------------------------------------------------------------

*Provide VIN only if Contractor does not have a valid TIN or DUNS number.

 

(c)          Invoice/Financing Request No.:

 

(d)         Date Invoice Prepared:

 

(e)          Contract No. and Order No. (if applicable):
                          

(f)            Effective Date:

 

(g)         Total Estimated Cost of Contract/Order.

 

(h)         Total Fixed Fee (if applicable):

 

(i)             Two-Way Match:          
Three-Way Match:

 

J)               Office of Acquisitions:

 

(k)          Central Point of Distribution:

 

(I)            This invoice/financing request represents reimbursable costs for
the period from                          to
                                        .

 

 

 

Cumulative

 

 

 

 

 

 

 

 

 

 

 

 

 

Percentage

 

 

 

 

 

 

 

 

 

 

 

 

 

of Effort/Hrs

 

Amount Billed

 

Cost at

 

Contract

 

 

 

Expenditure Category*
A

 

Negotiated
B

 

Actual
C

 

(m) Current
D

 

(n) Cumulative
E

 

Completion
F

 

Value
G

 

Variance
H

 

(o)   Direct Costs:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (1)   Direct Labor

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (2)   Fringe Benefits    %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (3)   Accountable Property

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (4)   Materials & Supplies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (5)   Premium Pay

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (6)   Consultant Fees

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (7)   Travel

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (8)   Subcontracts

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       (9)   Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Direct Costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(p)   Cost of Money    %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(q)   Indirect Costs    %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(r)   Fixed Fee    %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(s)   Total Amount Claimed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(t)   Adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(u)  Grand Totals

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“I certify that all payments requested are for appropriate purposes and in
accordance with the contract.”

 

 

 

 

 

 

(Name of

 

          (Title)

 

--------------------------------------------------------------------------------

*Attach details as specified in the contract or requested by the Contracting
Officer

 

6

--------------------------------------------------------------------------------

 

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

 

 

 

 

 

 

 

0

 

Not Hispanic or Latino

 

 

 

 

 

 

 

0

 

Unknown (Individuals not reporting ethnicity)

 

 

 

 

 

 

 

0

 

Ethnic Category: Total of All Subjects*

 

0

 

0

 

0

 

0

 

Racial Categories

 

 

 

 

 

 

 

 

 

American Indian/Alaska Native

 

 

 

 

 

 

 

0

 

Asian

 

 

 

 

 

 

 

0

 

Native Hawaiian or Other Pacific Islander

 

 

 

 

 

 

 

0

 

Black or African American

 

 

 

 

 

 

 

0

 

White

 

 

 

 

 

 

 

0

 

More than one race

 

 

 

 

 

 

 

0

 

Unknown or not reported

 

 

 

 

 

 

 

0

 

Racial Categories: Total of All Subjects*

 

0

 

0

 

0

 

0

 

 

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

 

 

 

 

 

 

 

0

 

Asian

 

 

 

 

 

 

 

0

 

Native Hawaiian or Other Pacific Islander

 

 

 

 

 

 

 

0

 

Black or African American

 

 

 

 

 

 

 

0

 

White

 

 

 

 

 

 

 

0

 

More Than One Race

 

 

 

 

 

 

 

0

 

Unknown or not reported

 

 

 

 

 

 

 

0

 

Racial Categories: Total of Hispanics or Latinos**

 

0

 

0

 

0

 

0

 

 

--------------------------------------------------------------------------------

*These totals must agree

**These totals must agree

 

Inclusion Enrollment Report

 

 

October, 2001

 

ATTACHMENT 3

 

--------------------------------------------------------------------------------

 

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
Indian or
Alaskan
Native

 

Asian or
Pacific
Islander

 

Black,
not of
Hispanic
Origin

 

Hispanic

 

White,
not of
Hispanic
Origin

 

Other
or
Unknown

 

Total

Female

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Male

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unknown

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Subpopulations of the minority groups should also be reported, using a similar
format.

 

Annual Technical Progress Report

 

 

July 1994

 

ATTACHMENT 4

 

--------------------------------------------------------------------------------

 

HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2006)

 

(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).

 

1.               In addition, the following regulations must be followed when
developing and implementing health and safety operating procedures and practices
for both personnel and facilities involving the use or handling of hazardous
materials and the conduct of research, development, or test projects:

 

(1)          29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450,
Occupational exposure to hazardous chemicals in laboratories; and other
applicable occupational health and safety standards issued by the Occupational
Health and Safety Administration (OSHA) and included in 29 CFR Part 1910.  These
regulations are available at:  http://www.osha.gov/comp-links.html

 

(2)          Nuclear Regulatory Commission Standards and Regulations, pursuant
to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.).  Copies may
be obtained from the U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001.

 

2.               The following guidelines are recommended for use in developing
and implementing health and safety operating procedures and practices for both
personnel and facilities:

 

(1)          Biosafety in Microbiological and Biomedical Laboratories, CDC and
NIH, HHS.  This publication is available at http://bmbl.od.nih.gov/index.htm.

 

(2)          Prudent Practices for Safety in Laboratories (1995), National
Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285,
Washington, DC 20055 (ISBN 0-309-05229-7).  This publication can be obtained by
telephoning 800-624-8373.  It also is available at
http://www.nap.edu/cataloq/4911.html.

 

(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 officers, 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 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 hazardous
operations.  Compliance with the provisions of this clause by subcontractors
will be the responsibility of the Contractor.

 

(End of Clause)

 

Safety and Health

 

 

HHSAR 352.223-70 (1/06)

 

ATTACHMENT 5

 

--------------------------------------------------------------------------------

 

PROCUREMENT OF CERTAIN EQUIPMENT, NIH(RC)-7

 

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-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 cost-reimbursement
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.

 

NIH(RC)-7 (4/1/84)

 

 

OMB Bulletin 81-16

 

ATTACHMENT 6

 

--------------------------------------------------------------------------------

 

RESEARCH PATIENT CARE COSTS — NIH(RC)-11

 

(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.

 

NIC(RC)-4 (4/1/84)

 

ATTACHMENT 7

 

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DISCLOSURE OF LOBBYING ACTIVITIES

Approved by OMB

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352
(See reverse for public burden disclosure.)

0348-0046

 

 

1.  Type of Federal Action:

2.  Status of Federal Action:

3.  Report Type:

 

o

a.  contract

b.  grant

c.  cooperative agreement

d.  loan

e.  loan guarantee

f.  loan insurance

 

o

a.  bid/offer/application

b.  initial award

c.  post-award

 

o

a.  initial filing

b.  material change

 

For Material Change Only:

Year                quarter               
date of last report                      

 

 

 

 

4.

Name and Address of Reporting Entity:

5.

If Reporting Entity in No. 4 is a Subawardee, Enter Name and

 

o Prime

o Subawardee

 

Address of Prime:

 

 

Tier                 , if known:

 

 

 

 

 

Congressional District, if known:  4c

 

Congressional District, if known:

 

 

 

6.  Federal Department/Agency:

7. 

Federal Program Name/Description:

 

 

 

 

 

 

 

 

CFDA Number, if applicable:                           

 

 

 

8.  Federal Action Number, if known :

9.

Award Amount, if known :

 

 

$

 

 

 

10. a.

Name and Address of Lobbying Registrant

b.

Individuals Performing Services

 

(if individual, last name, first name, MI):

 

(including address if different from No. 10a)

 

 

 

(last name, first name, MI):

 

 

 

 

 

 

11.

Information requested through this form is authorized

 

 

by title 31 U.S.C. section 1352.  This disclosure of

 

 

lobbying activities is a material representation of fact

 

 

upon which reliance was placed by the tier above

 

 

when this transaction was made or entered into.  This

 

 

disclosure is required pursuant to 31 U.S.C. 1352. 

 

 

This information will be available for public

 

 

inspection.  Any person who fails to file the required

 Signature:

 

 

disclosure shall be subject to a civil penalty of not less

 Print Name:

 

 

than $10,000 and not more than $100,000 for each

 Title:

 

 

such failure.

 Telephone No.:

 

 

Date:

 

 

 

 

Federal Use Only:

 

Authorized for Local Reproduction

 

 

Standard Form LLL (Rev. 7-97)

 

Disclosure of Lobbying Activities, SF-LLL

 

 

7/97

 

ATTACHMENT 8

 

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INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

 

This disclosure form shall be completed by the reporting entity, whether
subawardee or prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31
U.S.C. section 1352.  The filing of a form is required for each payment or
agreement to make payment to any lobbying entity 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 a Member of Congress in
connection with a covered Federal action.  Complete all items that apply for
both the initial filing and material change report.  Refer to the implementing
guidance published by the Office of Management and Budget for additional
information.

 

1.               Identify the type of covered Federal action for which lobbying
activity is and/or has been secured to influence the outcome of a covered
Federal action.

 

2.               Identify the status of the covered Federal action.

 

3.               Identify the appropriate classification of this report.  If
this is a followup report caused by a material change to the information
previously reported, enter the year and quarter in which the change occurred. 
Enter the date of the last previously submitted report by this reporting entity
for this covered Federal action.

 

4.               Enter the full name, address, city, State and zip code of the
reporting entity.  Include Congressional District, if known.  Check the
appropriate classification of the reporting entity that designates if it is, or
expects to be, a prime or subaward recipient.  Identify the tier of the
subawardee, e.g., the first subawardee of the prime is the 1st tier.  Subawards
include but are not limited to subcontracts, subgrants and contract awards under
grants.

 

5.               If the organization filing the report in item 4 checks
“Subawardee,” then enter the full name, address, city, State and zip code of the
prime Federal recipient.  Include Congressional District, if known.

 

6.               Enter the name of the Federal agency making the award or loan
commitment.  Include at least one organizational level below agency name, if
known.  For example, Department of Transportation, United States Coast Guard.

 

7.               Enter the Federal program name or description for the covered
Federal action (item 1).  If known, enter the full Catalog of Federal Domestic
Assistance (CFDA) number for grants, cooperative agreements, loans, and loan
commitments.

 

8.               Enter the most appropriate Federal identifying number available
for the Federal action identified in item 1 (e.g., Request for Proposal (RFP)
number; Invitation for Bid (IFB) number; grant announcement number; the
contract, grant, or loan award number; the application/proposal control number
assigned by the Federal agency).  Include prefixes, e.g., “RFP-DE-90-001.”

 

9.               For a covered Federal action where there has been an award or
loan commitment by the Federal agency, enter the Federal amount of the
award/loan commitment for the prime entity identified in item 4 or 5.

 

10.         (a) Enter the full name, address, city, State and zip code of the
lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the
reporting entity identified in item 4 to influence the covered Federal action.

 

(b)         Enter the full names of the individual(s) performing services, and
include full address if different from 10 (a).  Enter Last Name, First Name, and
Middle Initial (MI).

 

11.         The certifying official shall sign and date the form, print his/her
name, title, and telephone number.

 

According to the Paperwork Reduction Act, as amended, no persons are required to
respond to a collection of information unless it displays a valid OMB Control
Number.  The valid OMB control number for this information collection is OMB
No. 0348-0046.  Public reporting burden for this collection of information is
estimated to average 10 minutes per response, including time for reviewing
instructions, searching existing data sources, gathering and maintaining the
data needed, and completing and reviewing the collection of information.  Send
comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the Office of
Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC
20503.

 

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