Exhibit 10.1
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AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
UNDER DPAS (15 CFR 350) 1 11
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2. CONTRACT (Proc. Inst Ident.) 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
NO. W81XWH-05-2-0085 22 Sep 2005 W81XWH-5101-M260
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5. ISSUED BY CODE W81XWH 6. ADMINISTERED BY (If other than Item 5) CODE W81XWH
USA MED RESEARCH ACQ ACTIVITY USA MED RESEARCH ACQ ACTIVITY
000 XXXXXXXX XX ATTN: XXXXXXX XXXXXX
XXXX XXXXXXX XX 00000-0000 000-000-0000
XXXX XXXXXXX XX 00000
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7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, state and zip code) 8. DELIVERY
SIGA TECHNOLOGIES INC [ ] FOB ORIGIN [X] OTHER (See below)
XXXXXX X. XXXXX, PH.D. ----------------------------------------------
000 XXXXXXXXX XXX 9. DISCOUNT FOR PROMPT PAYMENT
RM 000 Xxx 0
XXX XXXX XX 00000-0000
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10. SUBMIT INVOICES 0 ITEM
(4 copies unless otherwise
------------------------------------------------------------------------------------ specified)
TO THE ADDRESS SHOWN IN:
CODE 1V4X4 FACILITY CODE
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11. SHIP TO/XXXX FOR CODE W23RYX 12. PAYMENT WILL BE MADE BY CODE HQ0345
USA MED RESEARCH AND MATERIEL COM DEFENSE FINANCE AND ACCOUNTING SERVICE
XXXXXXX XXXXXXXXXX DFAS-SA/FPA 000 XXXXXXXXXX XXXXXX
000 XXXXX XXXXXX PHONE: 000-000-0000
XXXX XXXXXXX XX 00000-0000 FAX: 000-000-0000
XXX XXXXXXX XX 00000-0000
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13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN 14. ACCOUNTING AND APPROPRIATION DATA
COMPETITION:
[ ] 10 U.S.C. 2304(c)( ) [ ] 41 U.S.C. 253(c)( ) See Schedule
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15A. ITEM NO. 15B. SUPPLIES/ SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
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SEE SCHEDULE
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15G. TOTAL AMOUNT OF CONTRACT $3,200,000.00
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16. TABLE OF CONTENTS
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(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)
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PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
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X A SOLICITATION/ CONTRACT FORM 1 I CONTRACT CLAUSES
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B SUPPLIES OR SERVICES AND PRICES/ COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
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C DESCRIPTION/ SPECS./ WORK STATEMENT J LIST OF ATTACHMENTS
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D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS
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E INSPECTION AND ACCEPTANCE K REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS
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F DELIVERIES OR PERFORMANCE
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G CONTRACT ADMINISTRATION DATA L INSTRS., CONDS., AND NOTICES TO OFFERORS
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H SPECIAL CONTRACT REQUIREMENTS M EVALUATION FACTORS FOR AWARD
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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17. [ ] CONTRACTOR'S NEGOTIATED AGREEMENT 18. [X] AWARD (Contractor is not required to sign this document.)
Contractor is required to sign this document Your offer on Solicitation Number ____________________________
and return copies to issuing office.) REF: See Paragraph A, Page 4
Contractor agrees to furnish and deliver all including the additions or changes made by you which additions or changes
items or perform all the services set forth or are set forth in full above, is hereby accepted as to the items listed
otherwise identified above and on any continuation above and on any continuation sheets. This award consummates the contract
sheets for the consideration stated herein. The which consists of the following documents: (a) the Government's
rights and obligations of the parties to this solicitation and your offer, and (b) this award/contract. No further
contract shall be subject to and governed by the contractual document is necessary.
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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19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME AND TITLE OF CONTRACTING OFFICER
XXXXXXX X. TAMA / CONTRACTING OFFICER
TEL: 000-000-0000 EMAIL:xxxxxxx.xxxx@xxx.xxxxx.xxxx.xxx
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19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. XXXXXX XXXXXX XX XXXXXXX 00X. DATE SIGNED
BY BY /s/ Xxxxxxx X. Tama 22-Sep-2005
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(Signature of person authorized to sign) (Signature of Contracting Officer)
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NSN 7540-01-152-8069 26-107 STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE GPO 1985 O - 469-794 Prescribed by XXX
XXX (00 XXX) 53.214(a)
W81XWH-05-2-0085
Page 2 of 12
Section 00010 - Solicitation Contract Form
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0001
Proposal Log No.: 05189001
COST
Period of Performance: 26 September 2005 through 25 October 2006 (Research
ends 25 September 2006)
PURCHASE REQUEST NUMBER: W81XWH-5101-M260
ESTIMATED COST $3,200,000.00
ACRN AA Funded Amount $3,200,000.00
FOB: Destination
DELIVERY INFORMATION
CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS UIC
0001 POP 26-SEP-2005 TO N/A USA MED RESEARCH AND MATERIEL W23RYX
25-OCT-2006 COM
XXXXXXX XXXXXXXXXX
000 XXXXX XXXXXX
XXXX XXXXXXX XX 00000-0000
FOB: Destination
W81XWH-05-2-0085
Page 3 of 12
Section 00800 - Special Contract Requirements
ACCOUNTING AND APPROPRIATION DATA
AA: 215204000000748112665801M02IM25GYP1H4IMF1ATD45087G003H4IMP1018064
AMOUNT: $3,200,000.00
CLAUSES INCORPORATED BY FULL TEXT
A. This award is made under the authority of 31 U.S.C. 6305 and 10 U.S.C. 2358.
The recipient's statement of work on pages 11-12 of the proposal dated 5 July
2005 and revised budget dated 15 July 2005 which are incorporated herein by
reference. The Catalog of Federal Domestic Assistance Number relative to this
award is CFDA 12.420.
GOVERNMENT INTERACTION (NOV 2000) (USAMRAA)The active participants in this award
are the U.S. Army Medical Research and Materiel Command (USAMRMC) and its
laboratories identified herein through the U.S. Army Medical Research
Acquisition Activity (USAMRAA). The following Laboratory will be the focus of
cooperative research conducted under this agreement:
LTC Xxxxxxx Xxxxxx
AFMS/SGRM
0000 Xxxxxxxx Xxxx, Xxxxx 0000
Xxxxx Xxxxxx, XX 00000
Xxxxxxx.Xxxxxx@xxxxxxxx.xx.xxx
B. ACCEPTANCE OF AWARD: The recipient is not required to countersign this
assistance award. In case of disagreement, the recipient shall notify the Grants
Officer and not assess the grant any costs until such disagreement(s) is
resolved.
C. USAMRAA GENERAL TERMS AND CONDITIONS: This assistance agreement is subject to
the USAMRAA General Terms and Conditions and to any special considerations as
contained in the below mentioned Section titled "Special Terms and Conditions".
These USAMRAA General Terms and Conditions are incorporated by reference with
the same force and effect as if they were given in full text. The full text of
the USAMRAA General Terms and Conditions may be accessed electronically at
xxxx://xxx.xxxxxxx.xxxx.xxx/xxxxx/xxxxx.xxx.
D. SPECIAL TERMS AND CONDITIONS
1. RESEARCH TECHNICAL REPORTING REQUIREMENTS
U.S. AIR FORCE SGR REPORTING REQUIREMENTS
USAF SGR reporting requirements for assistant agreement partners include monthly
and final reports as stated below:
W81XWH-05-2-0085
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A. MONTHLY TECHNICAL PROGRESS REPORT: The recipient shall submit a Monthly
Technical Progress Report covering work accomplished during each calendar month
of performance. It shall be brief, factual, and informal, and shall be prepared
in accordance with the sample report format on the following page. It shall
contain the following:
Section I - Recipient and award information
Section II - A brief introduction covering the purpose and scope of the
project at this stage and its relevance to the overall effort.
Section III - Using attached spreadsheet, provide overall progress to-date
on listed tasks, milestones reached and deliverables completed. Use Section III
on the form that follows to provide details on the following if more space is
required:
o Describe scientific progress for the month in terms of the tasks or
objectives listed in the statement of work for this assistant
agreement. Explain deviations where this isn't possible. Include data
where possible.
o Include a description of current problems (if any) that may impede
performance along with proposed corrective action planned or underway;
or anticipated problems that have a potential to impede progress, and
what corrective action is planned should the problem materialize.
o Include pertinent data and graphs in sufficient detail to explain any
significant results achieved.
o A report of any software or hardware (to include the source code)
developed specifically for this assistant agreement.
Section IV - Include overall financial profile on the report period and of
the project total to-date. Include the man-hours expended by position for the
reporting period and cumulatively during the assistant agreement. Provide
details as needed following the chart.
Section V - A description of work to be performed during the next reporting
period. Use additional page(s) as needed to present a brief statement of plans,
milestones expected, etc. Administrative comments such as a description of
proposed site visits and participation in technical meetings, journal
manuscripts in preparation, coordination with other organizations conducting
related work, etc.
Monthly Technical Progress Reports shall be prepared by the seventh day
following the month being reported, to be received within 10 days of the report
month. The Monthly Technical Progress Report shall be submitted via email in
Microsoft Word or Adobe PDF format to the following persons:
Grants Officer Representative (GOR):
Xxxxxxx Xxxxxx, Lt Col, USAF, BSC
Office of the Assistant Surgeon General, Modernization
AF/SGRM
0000 Xxxxxxxx Xxxx, Xxxxx 0000
Xxxxx Xxxxxx, XX 00000
Xxxxxxx.Xxxxxx@xxxxxxxx.xx.xxx
------------------------------
Director
U.S. Army Medical Research Acquisition Activity (USAMRAA)
ATTN: MCMR-AAA-B (Xxxxxxx Xxxxxx)
000 Xxxxxxxx Xxxxxx
Xxxx Xxxxxxx, XX 00000-0000
Xxxxxxx.Xxxxxx@xxxxx.xxxx.xxx
-----------------------------
W81XWH-05-2-0085
Page 5 of 12
The sample shown on the following page shall serve as the format for the monthly
report. Each item of the report shall be completed or addressed.
W81XWH-05-2-0085
Page 6 of 12
Monthly Report Format
Section I include:
o Recipient name, phone, email and address:
o Award no:
o Project title:
o Report date:
o Reporting period:
o Principal investigator:
o PI contact info (phone and email):
Section II: Introduction on purpose and scope of this portion of the project
effort:
Section III: Brief description of progress to-date (use this space for detailed
explanations, graphs, charts, etc., Otherwise use the attached
spreadsheet).
Section IV: Project expenditures to-date:
--------------------------------------- ------------------ -----------------
COST ELEMENTS THIS MONTH CUMULATIVE
--------------------------------------- ------------------ -----------------
Personnel
--------------------------------------- ------------------ -----------------
Fringe Benefits
--------------------------------------- ------------------ -----------------
Supplies
--------------------------------------- ------------------ -----------------
Equipment
--------------------------------------- ------------------ -----------------
Travel
--------------------------------------- ------------------ -----------------
Other Direct Costs
--------------------------------------- ------------------ -----------------
Subtotal
--------------------------------------- ------------------ -----------------
Indirect Costs
--------------------------------------- ------------------ -----------------
Fee
--------------------------------------- ------------------ -----------------
Total
--------------------------------------- ------------------ -----------------
In addition to the summary of costs required below, Section IV shall include:
o A report of any software or equipment procured with cost backup.
o Project-related trip reports, completed and included in the monthly
report directly following completion of travel and shall include the
following:
o Dates of travel
o Destination
o Purpose of trip
o Individual(s) contacted
o Brief synopsis
o Issues and challenges
o Recommendations or outcome
o Signature block
Section V - Milestones, tasks, deliverables, etc. expected to be completed in
the next month.
W81XWH-05-2-0085
Page 7 of 12
B. MANUSCRIPTS/REPRINTS/ABSTRACTS: A copy of manuscripts or subsequent
reprints resulting from the research shall be submitted the Grants Officer and
the Grants Officer Representative simultaneously with the submission of the
publication. Review of such manuscripts is for comments to the Principal
Investigator, not for approval or disapproval.
C. FINAL REPORT:
Format Requirements for Final Reports
a. A final report summarizing the entire research effort, citing data in the
annual reports (if any) and appended publications, shall be submitted at the end
of the award performance period. The final report will provide a complete
reporting of the research findings. Journal publications can be substituted for
detailed descriptions of specific aspects of the research, but an original copy
of each publication must be attached as an appendix and appropriately referenced
in the text. All final reports must include a bibliography of all publications
and meeting abstracts and a list of personnel (not salaries) receiving pay from
the research effort.
b. Although there is no page limitation for the reports, each report shall
be of sufficient length to provide a thorough description of the accomplishments
with respect to the approved Statement of Work. Submission of an original and
two copies of the report are required, as well as an electronic copy of the
report are required. The final report shall be submitted no later than the 20th
day after the completion of the research period. A copy of the final report
shall be forwarded to the following address:
Commander, U.S. Army Medical Research and Materiel Command
ATTN: MCMR-ZC-I
000 Xxxxx Xxxxxx
Xxxx Xxxxxxx, XX 00000-0000
A copy of the final report in electronic version shall also be forwarded GOR
via email to the following address:
Xxxxxxx.Xxxxxx@xxxxxxxx.xx.xxx
c. All reports shall have the following elements in this order: front cover,
Standard Form (SF 298), table of contents, introduction, body, key research
accomplishments, reportable outcomes, conclusions, references, and appendices.
Pages shall be consecutively numbered throughout the report. DO NOT RENUMBER
PAGES IN THE APPENDICES BUT DO INCLUDE THE APPENDICES IN THE PAGE COUNT IN BLOCK
15 ON THE SF 298. Xxxx all pages of the report that contain proprietary or
unpublished data that should be protected. DO NOT USE THE WORD "CONFIDENTIAL"
WHEN MARKING DOCUMENTS. Indicate in your letter accompanying the report that the
report contains proprietary or unpublished data, and that the distribution
statement should indicate the limitations of the report.
FRONT COVER: Sample front cover provided at xxxx://xxxx-xxx.xxxx.xxx. The
Accession Document (AD) Number should remain blank (samples may only be viewed
through secure servers).
STANDARD FORM 298: Sample SF 298 provided at xxxx://xxxx-xxx.xxxx.xxx. The
abstract in Block 13 must state the purpose, scope, major finding, and be an
up-to-date report of the progress in terms of results and significance. Subject
terms are keywords that may have previously assigned to the proposal abstract or
are keywords that may be significant to the research. The number of pages shall
include all pages that have printed data (including the front cover, SF 298,
table of contents, and all appendices). Missing or incorrect page numbers will
delay processing of reports.
TABLE OF CONTENTS: Sample table of contents provided at
xxxx://xxxx-xxx.xxxx.xxx.
INTRODUCTION: Narrative that briefly (one paragraph) describes the subject,
purpose and scope of the research.
W81XWH-05-2-0085
Page 8 of 12
BODY: This section of the report shall describe the research accomplishments
associated with each task outlined in the approved Statement of Work. Data
presentation shall be comprehensive in providing a complete record of the
research findings for the period of the report. Appended publications and/or
presentations may be substituted for detailed descriptions but must be
referenced in the body of the report. If applicable, for each task outlined in
the Statement of Work, reference appended publications and/or presentations for
details of result findings and tables and/or figures. The report shall include
negative as well as positive findings. Include problems in accomplishing any of
the tasks. Statistical tests of significance shall be applied to all data
whenever possible. Figures and graphs referenced in the text may be embedded in
the text or appended. Recommended changes or future work to better address the
research topic may also be included, although changes to the original Statement
of Work must be approved by the Contracting Officer. This approval must be
obtained prior to initiating any change to the original Statement of Work.
KEY RESEARCH ACCOMPLISHMENTS: Bulleted list of key research accomplishments
emanating from this research.
REPORTABLE OUTCOMES: Provide a list of reportable outcomes that have resulted
from this research to include:
o Manuscripts, Abstracts and presentations
o Patents and licenses applied for and/or issued
o Degrees obtained that are supported by this award
o Development of cell lines, tissue or serum repositories
o Infomatics such as databases and animal models, etc.
o Funding applied for based on work supported by this award
o Employment or research opportunities applied for and/or received based
on experience/training supported by this award
CONCLUSIONS: Summarize the results to include the importance and/or implications
of the completed research and when necessary, recommend changes on future work
to better address the problem. A "so what" section that evaluates the knowledge
as a scientific or medical product shall also be included in the conclusion of
the report.
REFERENCES: List all references pertinent to the report using a standard journal
format (i.e. format used in Science, Military Medicine, etc.).
APPENDICES: Attach all appendices that contain information that supplements,
clarifies or supports the text. Examples include original copies of journal
articles, reprints of manuscripts and abstracts, a curriculum vitae, patent
applications, study questionnaires, and surveys, etc.
BINDING: Because all reports are entered into the Department of Defense
Technical Reports database collection and are microfiched, it is recommended
that all reports be bound by stapling the pages together in the upper left hand
corner. All original reports shall be legible and contain original
photos/illustrations. Figures shall include figure legends and be clearly marked
with figure numbers.
2. ADVANCE PAYMENTS AND FULL FUNDING (NOV 2000) (USAMRAA)
a. Payments. Advance payments will be made to the recipient. Questions
relative to payment issues involving Defense Finance and Accounting Service
shall be directed to the Contract Specilaist's name stated in Block 6 of the
SF26 face page..
b. Electronic Funds Transfer. All advance payments to the recipient will be
made by electronic funds transfer (EFT). The recipient shall contact the
W81XWH-05-2-0085
Page 9 of 12
Defense Finance and Accounting System (DFAS) named on the face page of this
award to make arrangements for EFT. Failure to do so may result in nonpayment.
c. If the recipient fails to perform, the Grants Officer shall notify DFAS
in writing to withhold payments.
d. Advance Payment Schedule
Year One $3,200,000
Amount On or About
------ -----------
$1,000,000 Upon execution of this award
$733,334 1 January 2006
$733,333 1 April 2006
$733,333 1 July 2006
e. Financial Reporting Requirements: The recipient shall submit on a
quarterly basis a Standard Form 272, Federal Cash Transactions Report (form
available on web site xxxx://xxx.xxxxxxx.xxxx.xxx). Each report shall be
submitted to the U.S. Army Medical Research Acquisition Activity, ATTN:
MCMR-AAA-B, 000 Xxxxxxxx Xxxxxx, Xxxx Xxxxxxx XX 00000-0000 in accordance with
the following schedule:
Period Covered Due Date
-------------- --------
Jan - Mar 15 Apr
Apr - Jun 15 Jul
Jul - Sep 15 Oct
Oct - Dec 15 Jan
f. Interest Bearing Account. Unless exempted by applicable Treasury-State
agreements in accordance with the Cash Management Improvement Act (CMIA) (31
U.S.C. 3335), the recipient shall deposit all advance payments in an interest
bearing account. Interest over the amount of $250 per year shall be remitted
annually to the Department of Health and Human Services, Payment Management
System, X.X. Xxx 0000, Xxxxxxxxx, XX 00000. A copy of the transmittal letter
stating the amount of interest remitted shall be sent to the U.S. Army Medical
Research Acquisition Activity, ATTN:MCMR-AAA-B, 000 Xxxxxxxx Xxxxxx, Xxxx
Xxxxxxx, XX 00000-0000.
3. PROHIBITION OF USE OF LABORATORY ANIMALS (OCT 2003) (USAMRAA)
** PROHIBITION - READ FURTHER FOR DETAILS **
--------------------------------------------
Notwithstanding any other provisions contained in this award or incorporated by
reference herein, the recipient is expressly forbidden to use or subcontract for
the use of laboratory animals in any manner whatsoever without the express
written approval of the US Army Medical Research and Materiel Command, Animal
Care and Use Office. You will receive written approval to begin research under
the applicable protocol proposed for this award from the US Army Medical
Research and Materiel Command, Animal Care and Use Office under separate letter
to the recipient and Principal Investigator. A copy of this approval will be
provided to the US Army Medical Research and Acquisition Activity for the
official file. Non-compliance with any provision of this clause may result in
the termination of the award.
4. PROHIBITION OF USE OF HUMAN SUBJECTS (OCT 2003) (USAMRAA)
** PROHIBITION - READ FURTHER FOR DETAILS **
--------------------------------------------
W81XWH-05-2-0085
Page 10 of 12
Research at funded institutions using human subjects may not begin until the
U.S. Army Surgeon General's Human Subjects Research Review Board (HSRRB)
approves the protocol. Written approval to begin research or subcontract for the
use of human subjects under the applicable protocol proposed for this award will
be issued from the US Army Medical Research and Materiel Command, HSRRB, under
separate letter to the funded institution and the Principal Investigator. A copy
of this approval will be provided to the US Army Medical Research Acquisition
Activity for the official file. Non-compliance with any provision of this clause
may result in withholding of funds and or the termination of the award.
5. PROHIBITION OF USE OF HUMAN ANATOMICAL SUBSTANCES (OCT 2003) (USAMRAA)
** PROHIBITION - READ FURTHER FOR DETAILS**
-------------------------------------------
Research at funded institutions using human anatomical substances may not begin
until the U.S. Army Surgeon General's Human Subjects Research Review Board
(HSRRB) approves the protocol. Written approval to begin research or subcontract
for the use of human anatomical substances under the applicable protocol
proposed for this award will be issued from the US Army Medical Research and
Materiel Command, HSRRB, under separate letter to the funded institution and the
Principal Investigator. A copy of this approval will be provided to the US Army
Medical Research Acquisition Activity for the official file. Non-compliance with
any provision of this clause may result in withholding of funds and or the
termination of the award.
6. PROHIBITION OF USE OF HUMAN CADAVERS (OCT 2003) (USAMRAA)
** PROHIBITION - READ FURTHER FOR DETAILS**
-------------------------------------------
Research at funded institutions using human cadavers may not begin until the
U.S. Army Surgeon General's Human Subjects Research Review Board (HSRRB)
approves the protocol. Written approval to begin research or subcontract for the
use of human cadavers under the applicable protocol proposed for this award will
be issued from the US Army Medical Research and Materiel Command, HSRRB, under
separate letter to the funded institution and the Principal Investigator. A copy
of this approval will be provided to the US Army Medical Research Acquisition
Activity for the official file. Non-compliance with any provision of this clause
may result in withholding of funds and or the termination of the award.
7. DELIVERABLES:
Deliverablies shall be provided in accordance with the schedule stated on Page
13 of the proposal dated 5 July 2005.
CONTRACTOR SAFETY AND REPORTING (BDRP) (MAR 1999) (USAMRAA)
a. The contractor shall operate under established safety programs for all
biosafety levels of work as identified in the Safety Program Plan, which is
incorporated in this contract. These safety programs shall ensure that
personnel, facilities, and the environment are protected from accidents and
hazardous exposures.
b. The contractor shall conduct this contract work under established
operating procedures which ensure that all individuals who have access to areas
for storage, handling, and disposal of etiologic agents are trained and are
thoroughly familiar with safety requirements. Such procedures shall assure full
compliance with the regulatory standards cited above.
W81XWH-05-2-0085
Page 11 of 12
c. The contractor shall conduct an inspection and report the results of all
required biosafety inspections for all Research, Development, Test, or
Evaluation work in accordance with the below listed timeframes. As a minimum the
safety inspections shall address those factors identified in the Safety Program
Plan.
1. For Biosafety Level (BL) 1 and 2:
Time Inspector
Preaward Government designated Biosafety
Officer
Quarterly First line supervisor
Annual Contractor safety personnel
2. For Biosafety Level (BL) 3:
Time Inspector
Preaward Government designated Biosafety
Officer
Monthly First line supervisor
Annual Government designated Biosafety
Officer
3. For Biosafety Level (BL) 4:
Time Inspector
Preaward Government designated Biosafety
Officer
Monthly First line supervisor
Semiannual Government designated Biosafety
Officer
4. Copies of all biosafety inspection reports will be
distributed as follows:
Original:
In the contractor's records (Retained for at least three years)
One copy to the following:
U.S. Army Medical Research and Materiel Command
ATTN: MCMR-RCQ-S
000 Xxxxx Xxxxxx
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000
U.S. Army Medical Research and Materiel Command
ATTN: MCMR-PLD
000 Xxxxx Xxxxxx
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000
U.S. Army Medical Research Acquisition Activity
ATTN: MCMR-AAA
000 Xxxxxxxx Xxxxxx
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000
ETIOLOGIC AGENTS--BIOLOGICAL DEFENSE RESEARCH PROGRAM (MAR 1999) (USAMRAA)
a. For purpose of this contract etiologic agent--biological defense program is
defined as: any viable microorganism, or its toxin which causes or may cause
human disease, including those agents listed in 42 CFR 723 of the Department of
Health and Human Services regulations, and any agent of biological origin that
poses a degree of hazard to those agents and is further identified by the U.S.
Army as a threat agent. The contractor shall comply with the following when
working with etiologic agents:
1. 29 Code of Federal Regulations 1910
2. Occupational Health Standards, and the U.S. Department of Health and
Human Services (DHHS)
3. DHHS Publication No. 93-8395, Biosafety in Microbiological and Biomedical
Laboratories, 1993, as amended
W81XWH-05-2-0085
Page 12 of 12
4. 32 CFR 626 Biological Defense Safety Program
5. 32 CFR 627 Biological Defense Safety Program
b. Etiologic agents shall be packaged, labeled, shipped, and transported
in accordance with applicable Federal, state and local laws and regulations, to
include:
1. 42 CFR 72 (Interstate Shipment of Etiologic Agents)
2. 49 CFR 172 and 173 (Department of Transportation)
3. 9 CFR 122 (USDA Restricted Animal Pathogens)
4. International Air Transport Association Dangerous Goods Regulations.
5. The United States Postal Service shall not be used for transportation of
BDRP activities involving etiologic agents.
EMERGENCY COORDINATION AND REPORTING (BDRP) (MAR 1999) (USAMRAA)
a. The contractor shall review the Emergency Response Plan/Safety Program Plan
annually, during the month of July, in consultation with each participating
external support agency. The Emergency Response Plan shall be formally revised,
where necessary, to incorporate current emergency support requirements. The
revised Emergency Response Plan (with the agreements for emergency support as
appendices) shall be formalized in writing. A copy of the revision shall be
retained in your organizational safety office.
b. The contractor shall submit a letter report documenting the outcome of the
annual review of its Emergency Response Plan. The report shall include the dates
of the annual review and coordination, and shall identify and describe all
provisions that represent changes to the initial Emergency Response Plan or the
previous year's annual report. The report shall be submitted no later than
August 1 of each year, beginning with the first August during the performance of
your contract.
c. All reports identified in this provision shall be submitted to the following
address:
U.S. Army Medical Research and Materiel Command
ATTN: MCMR-RCQ-S
000 Xxxxx Xxxxxx
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000
