OMB Approval 2700-0042
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AWARD/CONTRACT
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1. THIS CONTRACT IS A RATED ORDER ►
UNDER DPAS (15 CFR 350)
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RATING
N/A
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PAGE OF PAGES
1 37
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2. CONTRACT (Proc. Inst. Ident.) NO
HHSN272201100031C
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3. EFFECTIVE DATE
09/30/2011
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4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
2292004
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5. ISSUED BY
CODE
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6. ADMINISTERED BY (if other than Item 5) CODE
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N/A
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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
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MID RCB-A
BAA-NIAID-DMID-NIHAI2010097
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7. NAME AND ADDRESS OF CONTRACTOR (No., street, county, state and ZIP CODE)
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8. DELIVERY
FOB Destination
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XOMA (US) LLC
2910 Seventh Street
Berkeley, CA 94710
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9. DISCOUNT FOR PROMPT PAYMENT
N/A
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10. SUBMIT INVOICES
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ITEM
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CODE
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FACILITY CODE
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ADDRESS SHOWN IN
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Art. G.3
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11. SHIP TO/MARK FOR CODE
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N/A
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12. PAYMENT WILL BE MADE BY CODE
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N/A
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Article F.2
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See Article G.3
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13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:
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ACCOUNTING AND APPROPRIATION DATA:
VIN: 1108484 SOCC 25.55
CAN: 8470038 Obligation Amount: $7,078,812
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15A. ITEM NO.
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15B. SUPPLIES/SERVICES
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15C. QUANTITY
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15D. UNIT
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15E. UNIT PRICE
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15F. AMOUNT
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Title: Production of Monoclonal Antibody Based
Therapeutics for Botulism
Period: September 30, 2011 through September 29, 2014
Contract Type: Cost Reimbursement - PFF - Completion
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15G. TOTAL AMOUNT OF CONTRACT ►
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$7,078,812
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16. TABLE OF CONTENTS
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(√)
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SEC
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DESCRIPTION
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PAGE(S)
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(√)
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SEC.
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DESCRIPTION
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PAGE(S)
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PART I – THE SCHEDULE
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PART II – CONTRACT CLAUSES
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x |
A
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SOLICITATION/CONTRACT FORM
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1
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x |
I
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CONTRACT CLAUSES
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30
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|||||||||||||||||
x |
B
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SUPPLIES OR SERVICES AND PRICE/COST
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4
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PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
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||||||||||||||||||||
x |
C
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DESCRIPTION/SPECS/WORK STATEMENT
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7
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x |
J
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LIST OF ATTACHMENTS
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37
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x |
D
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PACKAGING AND MARKING
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12
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PART IV – REPRESENTATIONS AND INSTRUCTIONS
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x |
E
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INSPECTION AND ACCEPTANCE
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13
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x |
K
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REPRESENTATIONS, CERTIFICATIONS
AND OTHER STATEMENTS OF OFFERORS
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38
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x |
F
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DELIVERIES OR PERFORMANCE
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14
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x |
G
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CONTRACT ADMINISTRATION DATA
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18
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o |
L
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INSTRS., CONDS., AND NOTICES TO OFFERORS
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x |
H
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SPECIAL CONTRACT REQUIREMENTS
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21
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o |
M
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EVALUATION FACTORS FOR AWARD
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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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.)
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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.
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19A. NAME AND TITLE OF SIGNER (Type or print)
/s/ Patrick J. Scannon, M.D. Ph.D.
Executive Vice President & Chief Scientific Officer
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20A. NAME OF CONTRACTING OFFICER
Richard L. Hartmann, Contracting Officer, MID RCB-A, OA, DEA, NIAID
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19A. NAME OF CONTRACTOR
/s/ Patrick J. Scannon
(Signature of person authorized to sign)
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19C. DATE SIGNED
26 Sep 11
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20B. UNITED STATES OF AMERICA
BY /s/ Richard L. Hartmann
(Signature of Contracting Officer)
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20C. DATE SIGNED
9/27/11
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NSN 7540-01-152-8069
PREVIOUS EDITION UNUSABLE
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26-107
Computer Generated
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STANDARD FORM 26 (REV. 4-85)
Prescribed by GSA
FAR (48 CFR) 53.214(a)
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PART I - THE SCHEDULE
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4
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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
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4
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ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
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4
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ARTICLE B.2. ESTIMATED COST - OPTION
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4
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ARTICLE B.3. ADVANCE UNDERSTANDINGS
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4
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ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS
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5
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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
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6
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ARTICLE C.1. STATEMENT OF WORK
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6
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ARTICLE C.2. REPORTING REQUIREMENTS
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6
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ARTICLE C.3. INVENTION REPORTING REQUIREMENT
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10
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SECTION D - PACKAGING, MARKING AND SHIPPING
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11
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SECTION E - INSPECTION AND ACCEPTANCE
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12
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SECTION F - DELIVERIES OR PERFORMANCE
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13
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ARTICLE F.1. PERIOD OF PERFORMANCE
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13
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ARTICLE F.2. DELIVERIES
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13
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ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY1998)
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16
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SECTION G - CONTRACT ADMINISTRATION DATA
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17
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ARTICLE G.1. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)
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17
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ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)
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17
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ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
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17
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ARTICLE G.4. INDIRECT COST RATES
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19
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ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
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19
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SECTION H - SPECIAL CONTRACT REQUIREMENTS
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20
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ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)
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20
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ARTICLE H.2. HUMAN SUBJECTS
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20
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ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
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20
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ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS
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21
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ARTICLE H.5. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV
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21
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ARTICLE H.6. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
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22
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ARTICLE H.7. SALARY RATE LIMITATION, HHSAR 352.231-70 (January 2010)
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22
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ARTICLE H.8. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH
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23
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ARTICLE H.9. NEEDLE DISTRIBUTION
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23
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ARTICLE H.10. PRESS RELEASES
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23
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ARTICLE H.11. RESTRICTION ON ABORTIONS
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23
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ARTICLE H.12. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
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23
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ARTICLE H.13. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION
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23
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ARTICLE H.14. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS
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23
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ARTICLE H.15. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)
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24
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ARTICLE H.16. ANIMAL WELFARE
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24
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ARTICLE H.17. OPTION PROVISION
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24
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ARTICLE H.18. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS
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25
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ARTICLE H.19. PUBLICATION AND PUBLICITY
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26
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ARTICLE H.20. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
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26
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ARTICLE H.21. SHARING RESEARCH DATA
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26
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ARTICLE H.22. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
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26
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ARTICLE H.23. HIGHLY PATHOGENIC AGENTS
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27
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ARTICLE H.24. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)
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27
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PART II - CONTRACT CLAUSES
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28
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SECTION I - CONTRACT CLAUSES
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28
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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
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34
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SECTION J - LIST OF ATTACHMENTS
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34
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1. Statement of Work
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34
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2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4
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34
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3. Inclusion Enrollment Report
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34
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4. Inclusion Table
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34
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5. Safety and Health
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34
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6. Research Patient Care Costs
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34
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7. Disclosure of Lobbying Activities, SF-LLL
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34
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8. Conference Expense Offset Worksheets
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34
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PART IV - REPRESENTATIONS AND INSTRUCTIONS
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35
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SECTION K - REPRESENTATIONS AND CERTIFICATIONS
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35
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1. Annual Representations and Certifications
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2. Annual Representations and Certifications, FAR Clause 52.204-8
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3. Human Subjects Assurance Identification Number
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4. Animal Welfare Assurance Number
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a.
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The fixed fee for the Base Period of this contract is $400,688. The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. 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.
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b.
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The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $7,078,812.
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c.
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If the Government exercises its option 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:
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Estimated Cost
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Fixed Fee
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Estimated Cost
Plus Fixed Fee
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Base Period
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$6,678,124
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$400,688
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$7,078,812
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Option 1
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$5,631,844
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$337,909
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$5,969,753
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Option 2
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$10,294,280
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$617,657
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$10,911,937
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Option 3
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$2,873,474
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$172,410
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$3,045,884
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Option 4
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$1,009,412
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$60,566
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$1,069,978
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Total (Base and Options)
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$26,487,134
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$1,589,230
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$28,076,364
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a.
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Establishment of Indirect Cost Rate
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b.
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Subcontract
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SUBCONTRACTORS
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UCSF
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USAMRIID
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SRI
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CETERO
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TOTAL PER
PERIOD
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Base
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$1,243,882
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$555,000
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$0.00
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$0.00
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$1,798,882
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Option 1
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$334,862
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$100,000
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$502,804
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$0.00
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$937,666
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Option 2
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$89,612
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$0.00
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$723,283
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$0.00
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$812,895
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Option 3
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$0.00
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$0.00
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$0.00
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$0.00
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$0.00
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Option 4
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$0.00
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$0.00
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$0.00
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$241,065
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$241,065
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Subcontractor Total
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$1,668,356
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$655,000
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$1,226,087
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$241,065
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$3,790,508
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c.
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Consultants
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Name
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Rate
Per Day
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Number of Days
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Total Cost
[Excluding] Travel
Not to Exceed
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Barbara Matthews
(Option 3)
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$275
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29
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$7,975
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Barbara Matthews
(Option 4)
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$275
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7
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$1,925
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TOTAL
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$9,900
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d.
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Advance Copies of Press Releases
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a.
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Items Unallowable Unless Otherwise Provided
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1.
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Acquisition, by purchase or lease, of any interest in real property;
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2.
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Special rearrangement or alteration of facilities;
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3.
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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.);
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4.
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Travel to attend general scientific meetings;
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5.
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Foreign travel;
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6.
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Consultant costs;
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7.
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Subcontracts;
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8.
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Patient care costs;
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9.
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Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more and “sensitive items” (defined as items of personal property (supplies and equipment that are highly desirable and easily converted to person use), regardless of acquisition value.
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b.
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Travel Costs
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1.
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Domestic Travel
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Domestic Travel Costs
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Base Period
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$8,752
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Option 1
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$43,760
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Option 2
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$48,496
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Option 3
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$16,320
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Option 4
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$8,752
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Total of Base and All Option(s)
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$126,080
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2.
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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.
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a.
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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 August 25, 2011, set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.
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a.
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Technical Reports
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1.
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Monthly Progress Report
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2.
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Annual Progress Report
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3.
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Annual Technical Progress Report for Clinical Research Study Populations
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4.
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Final Report
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5.
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Summary of Salient Results
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6.
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Report on Select Agents or Toxins and/or Highly Pathogenic Agents
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1.
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Any changes in the use of the Select Agent or Toxin including initiation of “restricted experiments,” 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.
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2.
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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:
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a.
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A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;
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b.
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A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b (http://www.selectagents.qov/Regulations.html) or listed on the U.S. National Select Agents Registry restricted experiments website (http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html);
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c.
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The name 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 or different location.
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d.
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For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.
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b.
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Other Reports/Deliverables
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1.
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Decision Gate Report
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a)
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Cover page that lists the contract number and title, the period of performance being reported, the Contractor’s name and address, telephone number, fax number, email address, and the date of submission.
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b)
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An introduction covering the purpose and scope of the contract effort, and the specific Decision Gate that has been reached.
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c)
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Document and summarize the results of work undertaken that supports the completion of the stage of product development, including an analysis of the data as it relates to the qualitative and quantitative criteria established for Go/No Go decision-making.
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d)
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Actual costs incurred in relation to costs estimated in the original approved budget.
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e)
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A description of the next stage of product development to be initiated and a request for COTR’s approval to proceed to the next stage of product development.
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2.
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Decision Gate and Work Plan Change Request
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a)
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A discussion of the justification/rationale for the request based on current data and a description of those data.
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b)
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Options for addressing the needed change/deviation from the approved timelines and/or decision gates, including a cost-benefit analysis of each option.
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c)
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A recommendation for the preferred option that includes a full analysis and discussion of the effects of the change on the entire product development program, timelines, and budget.
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3.
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Draft and Final Clinical Trial Protocols
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4.
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Strategic Staged Product Development Plan and Work Plan
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5.
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External Advisory Group Approval Request
|
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a)
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A brief biosketch for each member being proposed.
|
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b)
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A description of the roles and duties of each member.
|
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c)
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The proposed compensation for each member.
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6.
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Contract Meeting Reports
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7.
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Copies of FDA Correspondence and Meeting Summaries
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8.
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Institutional Biosafety Approval
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a.
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The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.
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b.
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For the purpose of this SECTION, the COTR is the authorized representative of the Contracting Officer.
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c.
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Inspection and acceptance will be performed at:
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d.
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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.
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a.
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The period of performance of this contract shall be from September 30, 2011 through September 29, 2014.
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a.
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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):
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Item
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Description
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Quantity
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Delivery Schedule
|
1
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Staged Specific Product Development Plan (SSPDP) and Workplan, and their revisions
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2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO
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Within 14 days after the contract award for the baseline SSPDP and Workplan, and during the course of the contract when revision is requested.
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2
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Monthly Technical Progress Reports
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2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO
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Each report is due on/before the 15th of each month following each reporting period.
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3
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Annual Technical Progress Reports
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2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO
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Each report is due on/before the 15th of the month following each anniversary date. Monthly Progress Reports will not be submitted the month the Annual Progress Report is due.
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4
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Final Invention Statement
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1 copy to CO
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On or before completion date of the contract.
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5
|
Draft and Final Technical Reports and Summary of Salient Results
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1 hard copy to COTR, 1 original copy to CO, 1 electronic copy to COTR and CO
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Draft Final Report is due 120 calendar days prior to the completion date of the contract. Final Report and Summary of Salient Results for the entire contract period to include key achievements (organized by Milestone) is due on or before the contract end date.
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6
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Technical Transfer Reports
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I hard copy to COTR, 1 electronic copy to COTR
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Each report will be provided as available.
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7
|
Meeting minutes and reports (kickoff and annual meetings and teleconferences with DMID)
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Electronic copy to COTR
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Within 5 business days for teleconference and within 21 calendar days for kickoff or annual meeting
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8
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Audit Reports
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2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO
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Within 30 days after the completion of the audits.
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9
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Clinical Protocols and supporting documents (draft, final, and revisions)
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1 electronic copy to COTR and CO
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Submit according to timelines or specified by DMID clinical operation guidelines.
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10
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GO/NO GO Decision Gate Reports or Deviation/Change request
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2 hard copies to COTR, 1 original copy to CO, 1 electronic copy to COTR and CO
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60 calendar days prior to date planned for exercising an option.
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Item
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Description
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Quantity
|
Delivery Schedule
|
11
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Draft and Final Regulatory Submission Documents to the FDA, including pre-IND, IND, and End of Phase I packages, as necessary.
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electronic copy to COTR and CO
|
Submit as described by DMID Regulatory and Clinical Operational guidelines.
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12
|
Copies of FDA correspondence and meeting summaries
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1 hard copy to COTR, 1 electronic copy to COTR and CO
|
Within 5 business days upon receipt of these documents from the FDA.
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13
|
Draft and Final nonclinical study protocols (safety, toxicity, and efficacy)
|
1 electronic copy to COTR and CO
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Prior to study initiation and as requested.
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14
|
Draft and Final Nonclinical Study Reports (safety, toxicity, and efficacy)
|
1 electronic copy to COTR and CO
|
Prior to regulatory submission to the FDA and as requested or as available.
|
15
|
Draft and Final Clinical Study Reports
|
1 electronic copy to COTR and CO
|
Prior to regulatory submission to the FDA and as requested or as available.
|
16
|
Other clinical reports (for example, IND annual reports, NIH clinical population reports, and clinical safety monitoring reports)
|
1 electronic copy to COTR
|
Submit according to timelines specified by NIAID-DMID clinical operation guidelines.
|
17
|
Sample of therapeutics (not for human use)
|
50 doses or equivalent amount delivered to COTR.
|
On or before the completion of the last exercised option.
|
b.
|
The items below are deliverables specific to the base award and each option:
|
Item
|
Stage
|
Reporting Deliverables
|
Days
|
Base Contract Award
|
Construct Evaluation and Selection
|
Lead candidate selection report containing the summary and results of evaluation of a panel of candidate mAbs.
|
On or before 1096 Days from the date of award.
|
Development of Stable Cell lines
|
Summary report identifying clones capable of expressing approximately 300 mg/L in shake flasks for each of the lead clones.
|
||
Assay and formulation development
|
Report summarizing the formulation and Freeze/Thaw stability of DS. DS analytical method(s) qualification reports.
|
||
Option 1
|
Generation of MCB
|
MCB validation report for each of the selected clones.
|
On or before 348 Days from the date of the executed option.
|
Process Development and Viral Clearance Screening
|
Technical Development Reports summarizing the production of each selected mAb DS to 95% purity by SEC and CE-SDS. R&D viral clearance reports documenting ~3 to 5 logs clearance for the Q-Sepharose and HIC steps.
|
||
DS test method qualification reports available prior to release of GMP materials.
|
Item
|
Stage
|
Reporting Deliverables
|
Days
|
Process verification and engineering lot scale up
|
Report documenting purification and recovery process yield and purity at 50 L scale for each lead mAb; DS CE-SDS and SEC must show >95% purity.
|
||
Technical Transfer Report for cell culture and downstream steps (with Freeze/Thaw).
|
|||
Option 2
|
Manufacturing
|
Approved Batch Records.
|
On or before 927 Days from the date of the executed option
|
Process report containing GMP lot DS production and testing information.
|
|||
Approved plan for DS storage ar-70°C in validated and monitored freezers.
|
|||
Process report containing GLP viral clearance testing information targeting ~15 log cumulative viral clearance for the downstream process.
|
|||
Divalent DP formulation
|
Process report containing final formulation.
|
||
Process report containing developed and qualified analytical methods. Stability protocols, interim and final stability reports for GMP materials.
|
|||
Completed and QA approved BRs for filling and finishing and CoA for DP testing.
|
|||
Option 3
|
Assay development for
pre-clinical work
|
Validated PK assay reports for rat, cyno, and human sera.
|
On or before 926 Days from the date of the executed option
|
Validated rat and human HAHA (or “ADA”) assay report.
|
|||
Pre-Clinical Toxicology
|
Draft and final Report for non-GLP range finding toxicology study in rat.
|
||
Final report for GLP TCR study.
|
|||
Final report for GLP PK study in rat.
|
|||
Final report for GLP multi-dose toxicology.
|
|||
Final Report for GLP safety pharmacology.
|
|||
IND preparation and filing
|
Pre-IND briefing package and pre-IND meeting notes.
|
Item
|
Stage
|
Reporting Deliverables
|
Days
|
IND documents approved prior to submission.
|
|||
Option 4
|
Clinical Trial
|
Briefing Package to NIAID prior to start of Phase 1 and include patient consent and history forms, and approved protocol.
|
On or before 356 Days from the date of the executed option
|
Project completion
|
Briefing Package to NIAID for end of Phase 1 (clinical data) and final contract report.
|
c.
|
The above items shall be addressed and delivered:
|
|
Contracting Officer’s Technical Representative (COTR)
|
|
National Institutes of Health
|
|
National Institute of Allergy and Infectious Diseases
|
|
Division of Microbiology and Infectious Diseases
|
|
Office of Biodefense Research Affairs
|
|
Drug Development Section
|
|
6610 Rockledge Drive, Room 3610
|
|
Bethesda, Maryland 20892
|
|
and
|
|
Contracting Officer (CO)
|
|
Microbiology and Infectious Diseases Research Contracts Branch A
|
|
Office of Acquisitions, DEA, NIAID, NIH, DHHS
|
|
6700-B Rockledge Drive, Room 3214
|
|
Bethesda, Maryland 20892-7612
|
|
(Express Mail: Bethesda, MD 20817)
|
Name
|
Title
|
Milan T. Tomic
|
Principal Investigator
|
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.
|
Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.
|
a.
|
The original invoice shall be submitted to the following designated billing office:
|
b.
|
One copy of the invoice shall be submitted to the following approving official:
|
2.
|
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:
|
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 payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [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.] If the Contractor has neither a TIN, DUNS, or VIN, 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 Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [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.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
|
e.
|
Invoice Matching Option. This contract requires a two-way match.
|
f.
|
Unique Invoice 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.
|
b.
|
Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.
|
c.
|
The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:
|
a.
|
Contractor Performance Evaluations
|
b.
|
Electronic Access to Contractor Performance Evaluations
|
a.
|
The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.
|
b.
|
The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations,
duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.
|
c.
|
If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP,
terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Human Subject Assurances.
|
·
|
the registration of certain “applicable clinical trials” (see Definitions at: http://grants.nih.gov/ClinicalTrials_fdaaa/_definitions.htm) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and
|
·
|
the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.
|
a.
|
Pursuant to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level I in effect on the date an expense is incurred.
|
b.
|
For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary” have the same meaning and are collectively referred to as “direct salary” in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).
|
c.
|
The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.
|
d.
|
See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods.
|
a.
|
Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.
|
b.
|
The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.
|
c.
|
The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.
|
d.
|
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the
Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Assurances.
|
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.
|
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.
|
a.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
|
FAR
CLAUSE NO.
|
DATE
|
TITLE
|
52.202-1
|
Jul 2004
|
Definitions (Over the Simplified Acquistion Threshold)
|
52.203-3
|
Apr 1984
|
Gratuities (Over the Simplified Acquisition Threshold)
|
52.203-5
|
Apr 1984
|
Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)
|
52.203-6
|
Sep 2006
|
Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)
|
52.203-7
|
Oct 2010
|
Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)
|
52.203-8
|
Jan 1997
|
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
|
52.203-10
|
Jan 1997
|
Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
|
52.203-12
|
Oct 2010
|
Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)
|
52.204-4
|
May 2011
|
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (Over the Simplified Acquisition Threshold)
|
52.204-7
|
Apr 2008
|
Central Contractor Registration
|
52.204-10
|
Jul 2010
|
Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)
|
52.209-6
|
Dec 2010
|
Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
|
52.215-2
|
Oct 2010
|
Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]
|
52.215-8
|
Oct 1997
|
Order of Precedence - Uniform Contract Format
|
52.215-10
|
Aug 2011
|
Price Reduction for Defective Certified Cost or Pricing Data (Over $700,000)
|
52.215-12
|
Oct 2010
|
Subcontractor Cost or Pricing Data (Over $700,000)
|
52.215-14
|
Oct 2010
|
Integrity of Unit Prices (Over the Simplified Acquisition Threshold)
|
52.215-15
|
Oct 2010
|
Pension Adjustments and Asset Reversions (Over $700,000)
|
FAR
CLAUSE NO.
|
DATE
|
TITLE
|
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 2010
|
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications
|
52.215-23
|
Oct 2009
|
Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)
|
52.216-7
|
Jun 2011
|
Allowable Cost and Payment
|
52.216-8
|
Jun 2011
|
Fixed Fee
|
52.219-8
|
Jan 2011
|
Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold)
|
52.219-9
|
Jan 2011
|
Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)
|
52.219-16
|
Jan 1999
|
Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction)
|
52.222-2
|
Jul 1990
|
Payment for Overtime Premium (Over the Simplified Acquisition Threshold) (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 2010
|
Equal Opportunity for Veterans ($100,000 or more)
|
52.222-36
|
Oct 2010
|
Affirmative Action for Workers with Disabilities
|
52.222-37
|
Sep 2010
|
Employment Reports on Veterans ($100,000 or more)
|
52.222-40
|
Dec 2010
|
Notification of Employee Rights Under the National Labor Relations Act Over the Simplified Acquisition Threshold)
|
52.222-50
|
Feb 2009
|
Combating Trafficking in Persons
|
52.222-54
|
Jan 2009
|
Employment Eligibility Verification (Over the Simplified Acquisition Threshold)
|
52.223-6
|
May 2001
|
Drug-Free Workplace
|
52.223-18
|
Aug 2011
|
Encouraging Contractor Policies to Ban Text Messaging While Driving
|
52.225-1
|
Feb 2009
|
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
|
FAR
CLAUSE NO.
|
DATE
|
TITLE
|
52.232-9
|
Apr 1984
|
Limitation on Withholding of Payments
|
52.232-17
|
Oct 2010
|
Interest (Over the Simplified Acquisition Threshold)
|
52.232-20
|
Apr 1984
|
Limitation of Cost
|
52.232-23
|
Jan 1986
|
Assignment of Claims
|
52.232-25
|
Oct 2008
|
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 $700, 000)
|
52.242-4
|
Jan 1997
|
Certification of Final Indirect Costs
|
52.242-13
|
Jul 1995
|
Bankruptcy (Over the Simplified Acquisition Threshold)
|
52.243-2
|
Aug 1987
|
Changes - Cost Reimbursement, Alternate V (Apr 1984)
|
52.244-2
|
Oct 2010
|
Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007)
|
52.244-5
|
Dec 1996
|
Competition in Subcontracting (Over the Simplified Acquisition Threshold)
|
52.244-6
|
Dec 2010
|
Subcontracts for Commercial Items
|
52.245-1
|
Aug 2010
|
Government Property
|
52.245-9
|
Aug 2010
|
Use and Charges
|
52.246-23
|
Feb 1997
|
Limitation of Liability (Over the Simplified Acquisition Threshold)
|
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)
|
352.203-70
|
Jan 2006
|
Anti-Lobbying (Over Simplified Acquisition Threshold)
|
352.216-70
|
Jan 2006
|
Additional Cost Principles
|
352.222-70
|
Jan 2010
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
352.227-70
|
Jan 2006
|
Publications and Publicity
|
352.228-7
|
Dec 1991
|
Insurance - Liability to Third Persons
|
HHSAR
CLAUSE NO.
|
DATE
|
TITLE
|
352.233-71
|
Jan 2006
|
Litigation and Claims
|
352.242-70
|
Jan 2006
|
Key Personnel
|
352.242-73
|
Jan 2006
|
Withholding of Contract Payments
|
352.242-74
|
Apr 1984
|
Final Decisions on Audit Findings
|
c.
|
THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.
|
d.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
|
1.
|
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (April 2010).
|
2.
|
FAR Clause 52.203-14, Display of Hotline Poster(s) (December 2007).
|
Poster(s)
|
Obtain From”
|
HHS Contractor Code of Ethics
and Business Conduct Poster
|
http://oig.hhs.gov/fraud/hotline/
OIG Hotline Poster.pdf
|
3.
|
FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).
|
4.
|
FAR Clause 52.217-6, Option for Increased Quantity (March 1989).
|
5.
|
FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (January 2011).
|
6.
|
FAR Clause 52.227-16, Additional Data Requirements (June 1987).
|
7.
|
FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001).
|
8.
|
FAR Clause 52.251-1, Government Supply Sources (August 2010).
|
e.
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:
|
1.
|
HHSAR Clause 352.201-70, Paperwork Reduction Act (January 2006).
|
2.
|
HHSAR Clause 352.223-70, Safety and Health (January 2006).
|
3.
|
HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to Persons with Disabilities (January 2001).
|
f.
|
NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES: The following clauses are attached and made a part of this contract:
|
1.
|
NIH(RC)-11, Research Patient Care Costs (4/1/84).
|
g.
|
FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (January 2011)
|
|
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.
|
NIH Representations & Certifications, dated October 1, 2010.
|
|
4.
|
Human Subjects Assurance Identification Number FWA00016408.
|
|
5.
|
Animal Welfare Assurance Number 000699.
|
|
a.
|
A defined contract structure to clearly delineate the scope of work for each base and option period throughout the entire program.
|
|
b.
|
Defined goals for performance of product development activities for each base and option period throughout the entire program.
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c.
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Defined entry criteria as Go/No Go decision gates for exercising each option.
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d.
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Quantitative and qualitative criteria and accompanying data elements for assessing the scientific merit and feasibility of moving to the next set of product development activities.
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e.
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A detailed timeline for the base and option periods covering the initiation, conduct, and completion of product development activities and a budget linked to these activities.
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f.
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Detailed description of the technical approaches in the Workplan to implement the SSPDP.
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a.
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Sufficiently detailed documentation and analysis to support successful completion of the activities according to the pre-determined qualitative and quantitative criteria that define the Go/No Go decision.
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b.
|
Summary costs incurred to complete the activities.
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c.
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Description of the next option for product development and a revised Work Plan, and if necessary, an updated budget, along with the request for approval to proceed to the next option or activities in product development.
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a.
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Discussion of the justification/rationale for the proposed changes.
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b.
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Options for addressing the needed change/deviation from the approved timelines and/or decision gates, including a cost-benefit analysis of each option.
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c.
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Recommendations for the preferred product development option and a full analysis and discussion of the impact of the change on the entire product development program, timelines, and budget.
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·
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Selection and development of lead antibody constructs
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·
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Potency studies in the mouse protection assay
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·
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Pharmacokinetic (PK) and safety studies in animals
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·
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Tissue cross-reactivity (TCR) studies
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·
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Development of analytical reagents and assays to measure PK and immunogenicity
|
·
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Identify and develop optimal cell lines
|
·
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Prepare Master Cell Banks (MCB)
|
·
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Develop master production batch records
|
·
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Develop scaleable fermentation processes
|
·
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Develop production purification processes
|
·
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Qualify analytical assays for in-process, Drug Substance (DS) and Drug Product (DP) characterization
|
·
|
Scale-up the production processes to pilot scale
|
·
|
Produce GMP material to support IND-enabling studies and the Phase I clinical trial
|
·
|
Conduct quality assessment of antibody product and stability testing of the clinical materials
|
|
a.
|
Comply with all current Federal regulations pertinent to the conduct of research involving human subject protection and Good Clinical Practices.
|
|
b.
|
Comply with the current NIAID-DMID clinical trial operational guidance, developed under the scope of the Clinical Terms of Award, which addresses specifically the implementation processes for conducting, monitoring, and safety reporting of a clinical trial performed under NIAID-DMID contract.
|
|
c.
|
Obtain from the NIAID-DMID approval of Investigational New Drug (IND) sponsorship. If approved by DMID, the Contractor shall serve as the product IND holder and be responsible for:
|
|
i.
|
Developing and submitting all draft and final clinical trial protocols, supporting documents, and any document amendments to the COTR for NIAID-DMID review and approval.
|
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ii.
|
Submitting the following supporting documents at time of the draft clinical trial protocols submission for NIAID-DMID review and approval: sample informed consent forms and current clinical investigator’s brochures.
|
|
iii.
|
Submitting the following supporting documents for NIAID-DMID review and approval prior to study initiation: case report forms, site quality management plan, enrollment plan, clinical data management plan, manual of procedures (pharmacy manual and laboratory manual shall be provided if not covered under the manual of procedures), safety oversight plan, protocol-specific clinical monitoring plan, local Institutional Review Board committee approvals, and FDA acceptance correspondence related to IND filing.
|
|
vi.
|
Developing, submitting, and maintaining all relevant documentation for IND submission to comply with the FDA IND requirement.
|
|
v.
|
Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review pre-IND, IND, and End of Phase I packages, as necessary.
|
|
vi.
|
Proposing clinical sites and/or Contract Research Organization (CRO) to participate in the conduct of the funded clinical trials and maintaining adequate oversights including performing site assessment and site initiation per FDA regulation and NIAID-DMID guidance.
|
|
v.
|
Preparing and submitting draft FDA communication for NIAID-DMID review and comments prior to submitting to the FDA; submitting all documentation to the FDA in a timely manner, consistent with timelines set out in the contract and by the FDA.
|
|
viii.
|
Including NIAID-DMID staff, as designated by the COTR, in meetings and teleconferences with the FDA.
|
|
ix.
|
Providing to the COTR copies of all FDA correspondence and meeting minutes that are relevant to the therapeutic product within five (5) business days upon receipt of these communications.
|
|
x.
|
Registering the trial and posting study protocol on clinicaltrials.gov website prior to enrollment and updating as required.
|
|
xi.
|
Provide a Federal Wide Assurance (FWA) for the IND sponsor and each participating site prior to initiation of the study.
|
|
xii.
|
Work with NIAID-DMID to obtain Clinical Exemption to OMB Clearance Requirements.
|
|
a.
|
Be responsible for the development and implementation of data management and quality control systems/procedures, including the transmission, storage, confidentiality, and retrieval of all study data, by using commercially available CFR Part 11 compliant database or information system.
|
|
b.
|
Provide for the statistical design and analysis of data resulting from the research undertaken.
|
|
c.
|
Provide raw data and/or specific analyses of data generated with contract funding to the COTR
|
|
d.
|
Ensure strict adherence to FDA regulations and guidance, including requirements for the conduct of animal studies and assays under GLP, the manufacturing of the therapeutic candidate/product under cGMP, and the conduct of clinical trials under GCP standards. The Contractor shall maintain quality assurance documentation to support adherence in these areas.
|
|
e.
|
Arrange for independent audits, as needed or as requested by the COTR and the CO. In addition, the Contractor shall ensure that all Contractor and/or subcontractor records and staff are available for site visits or audits. The Contractor shall provide interim and final audit reports to the COTR and the CO within thirty (30) calendar days of the completion of the audit.
|
|
a.
|
Performance of IND-enabling assays and animal studies under GLP.
|
|
b.
|
Production, characterization, and release testing of therapeutic agent under cGMP.
|
|
c.
|
Performance of clinical trial(s) in humans under GCP.
|
|
d.
|
Humane care and use of vertebrate animals.
|
|
e.
|
Handling, storing and shipping of potentially dangerous biological and chemical agents, including Select Agents, under biosafety levels required for working with the biological agents under study.
|
|
f.
|
Obtaining approval from their Institutional Biosafety Committee. At the request of the COTR, the Contractor shall provide copies of materials submitted for Institutional Biosafety Committee Review and documentation of approval of experiments.
|
|
i.
|
The overall management, integration, and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, direction, and completion of all contract activities including monitoring and tracking day-to-day progress and timelines, and coordinating communication, project activities, and costs incurred.
|
|
ii.
|
Regular and effective communication with the COTR and the CO.
|
|
iii.
|
A PI with technical responsibility for overall project management and communication, tracking performance, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors.
|
|
iv.
|
Administrative staff with responsibility for financial management and reporting on all administrative activities conducted by the Contractor and any subcontractors on all administrative activities conducted by the Contractor and any subcontractors.
|
|
v.
|
A Project Manager to manage adherence to the project plan, track budget and progress, meet reporting requirements, and act under the direction of the PI.
|
·
|
Plan and coordinate with the COTR on selecting date and time for the Kick-off Meeting within thirty (30) calendar days of the effective date of the contract and subsequent Annual Review Meetings.
|
·
|
Draft an agenda of meeting objectives and topics within fourteen (14) calendar days in advance of meetings.
|
·
|
Distribute updated SSPDP and Work Plan and Annual Technical progress reports fourteen (14) calendar days prior to meetings that include project status, deliverables, milestones, and metrics.
|
·
|
Provide a kick-off and annual meeting reports that contains an executive summary, meeting minutes, action items and copy of the presentations within twenty-one (21) calendar days after these meetings.
|