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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------
FORM 10-Q/A
(Amendment No. 1)
(Mark One)
|X| Quarterly Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the Quarter Ended September 30, 2006
OR
|_| Transition Report Pursuant To Section 13 Or 15(d) Of the Securities
Exchange Act of 1934
For the Transition Period from ___________ to _____________
Commission File No. 0-23047
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SIGA Technologies, Inc.
(Exact name of registrant as specified in its charter)
A Delaware Corporation IRS Employer No. 13-3864870
420 Lexington Avenue, Suite 408, New York, NY 10170
Telephone Number (212) 672-9100
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes |X| No |_|.
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of "accelerated
filer and large accelerated filer" in Rule 12b-2 of the Exchange Act. (Check
one):
Large Accelerated Filer |_| Accelerated Filer |_| Non-Accelerated Filer |X|.
Indicate by check mark whether the registrant is a shell company (as defined in
rule 12b-2 of the Exchange Act). Yes |_| No |X|.
As of October 31, 2006 the registrant had 31,765,621 shares of common stock
outstanding.
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EXPLANATORY NOTE
This Amendment No. 1 on Form 10-Q/A (this "Amendment") amends the
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2006
filed on November 1, 2006 (the "Original Filing"). We have filed this Amendment
solely to include the information required by Part II, Item 6 - Exhibits. This
information was inadvertently omitted from the Original Filing. In addition, in
connection with the filing of this Amendment and pursuant to the rules of the
Securities and Exchange Commission, we are including with this Amendment certain
currently dated certifications.
Except as described above, no other changes have been made to the Original
Filing. This Amendment has not resulted in any changes to our previously
reported financial results. This Amendment continues to speak as of the date of
the Original Filing, and we have not updated the disclosures contained in this
Amendment to reflect any events that occurred at a date subsequent to the
Original Filing.
1
Part II
Other information
Item 6. Exhibits
* 10.1 Contract, dated September 29, 2006, between SIGA Technologies, Inc.
and the National Institute of Allergy and Infectious Diseases of the
National Institutes for Health.
* 31 Certification of Chief Financial Officer and Acting Chief Executive
Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
* 32 Certification of Chief Financial Officer and Acting Chief Executive
Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
* Filed herein
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SIGA Technologies, Inc.
(Registrant)
Date: November 13, 2006 By: /s/ Thomas N. Konatich
------------------------
Thomas N. Konatich
Chief Financial Officer and
Acting Chief Executive Officer
3
EXHIBIT 10.1
ADB No. N01-AI-60014 OMB Approval 2700-0042 / 0990-0115
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|1. THIS CONTRACT IS A RATED ORDER |RATING |PAGE OF PAGES
| UNDER DPAS (15 CFR 350) > | | |
AWARD/CONTRACT | | N/A | 1 | 33
- ------------------------------------------------------------------------------------------------------------------------------------
2. CONTRACT (Proc. Inst. Ident.) NO. |3. EFFECTIVE DATE |4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
HHSN266200600014C | September 29, 2006 | DMID 2006-0473
- ------------------------------------------------------------------------------------------------------------------------------------
5. ISSUED BY CODE| |6. ADMINISTERED BY (If other than Item 5) CODE | N/A
----------------------------| -----------------
National Institutes of Health, NIAID |
DEA, Office of Acquisitions | MID RCB-A
6700-B Rockledge Dr., Room 3214, MSC 7612 |
Bethesda, Maryland 20892-7612 |
|
- ------------------------------------------------------------------------------------------------------------------------------------
7. NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code) |8. DELIVERY
| [ ] FOB ORIGIN [X] OTHER (See below)
SIGA Technologies, Inc. | FOB Destination
4575 SW Research Way, Suite 230 |--------------------------------------------
Corvallis, OR 97333 |9/ DISCOUNT FOR PROMPT PAYMENT
| N/A
|
|--------------------------------------------
|10. SUBMIT INVOICES |ITEM
- ---------------------------------------------------------------------------------------| |
CODE |FACILITY CODE |ADDRESS SHOWN IN: |Art. G.3
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11. SHIP TO/MARK FOR CODE | N/A |12. PAYMENT WILL BE MADE BY CODE | N/A
------------------------| -----------------
|
Article F.1 | See Article G.3
|
- -----------------------------------------------------------------|------------------------------------------------------------------
13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: N/A |14. ACCOUNTING AND APPROPRIATION DATA:
| EIN: 1-133864870-AI SOC 25.55 CAN: 6-8467101
[ ] 10 U.S.C. 2304(c)( ) [ ] 41 U.S.C. 253(c)( ) | Obligate: $8,191,538
|
- -----------------------------------------------------------------|------------------------------------------------------------------
15A. ITEM NO. | 15B. SUPPLIES/SERVICES | 15C. QUANTITY | 15D. UNIT | 15E. UNIT PRICE | 15F. AMOUNT
- -----------------------------------------------------------------|---------------|-----------|--------------------|-----------------
|FY06 | | |$ 3,191,538
Title: NDA Enabling Development for SIGA-246: A Smallpox |FY07 | | |$10,368,051
Antiviral Drug |FY08 | | |$ 2,984,928
Period: September 29, 2006 - September 28, 2009 | | | |
Contract Type: Cost Reimbursement Completion | | | |
RFP No.: BAA-NIH-NIAID-DMID-06-35 | | | |
- ------------------------------------------------------------------------------------------------------------------|-----------------
15G. TOTAL AMOUNT OF CONTRACT > |$16,554,517
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16. TABLE OF CONTENTS
- ------------------------------------------------------------------------------------------------------------------------------------
(X)| SEC. | DESCRIPTION | PAGE(S) | (X) | SEC. | DESCRIPTION | PAGE(S)
- -----------------------------------------------------------------|------------------------------------------------------------------
PART I - THE SCHEDULE | PART II - CONTRACT CLAUSES
- -----------------------------------------------------------------|------------------------------------------------------------------
[X]| A |SOLICITATION/CONTRACT FORM | 1 | [X] | I |CONTRACT CLAUSES | 25
- ----|------|-------------------------------------------|---------|------------------------------------------------------------------
[X]| B |SUPPLIES OR SERVICES AND PRICE/COST | 4 | PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
- ----|------|-------------------------------------------|---------|------------------------------------------------------------------
[X]| C |DESCRIPTION/SPECS./WORK STATEMENT | 7 | [X] | J |LIST OF ATTACHMENTS | 32
- ----|------|-------------------------------------------|---------|------------------------------------------------------------------
[X]| D |PACKAGING AND MARKING | 12 | PART IV - REPRESENTATIONS AND INSTRUCTIONS
- ----|------|-------------------------------------------|---------|------------------------------------------------------------------
[X]| E |INSPECTION AND ACCEPTANCE | 12 | [X] | K |REPRESENTATIONS, CERTIFICATIONS | 33
- ----|------|-------------------------------------------|---------| | |AND OTHER STATEMENTS OF OFFERORS |
[X]| F |DELIVERIES OR PERFORMANCE | 13 | | | |
- ----|------|-------------------------------------------|---------|-----|------|-------------------------------------------|---------
[X]| G |CONTRACT ADMINISTRATION DATA | 15 | [ ] | L |INSTRS., CONDS., AND NOTICES TO OFFERORS |
- ----|------|-------------------------------------------|---------|-----|------|-------------------------------------------|---------
[X]| H |SPECIAL CONTRACT REQUIREMENTS | 17 | [ ] | M |EVALUATION FACTORS FOR AWARD |
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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17. [X] CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is | 18. [ ] AWARD (Contractor is not required to sign this
required to sign this document and return __2__ copies to | document.) Your offer on Solicitation Number
issuing office.) Contractor agrees to furnish and deliver all | __________________________, including the additions or changes
items or perform all the services set forth or otherwise | made by you which additions or changes are set forth in full
identified above and on any continuation sheets for the | above, is hereby accepted as to the items listed above and on
consideration stated herein. The rights and obligations of the | any continuation sheets. This award consummates the contract
parties to this contract shall be subject to and governed by the | which consists of the following documents: (a) the Government's
following documents: (a) this award/contract, (b) the | solicitation and your offer, and (b) this award/contract. No
solicitation, if any, and (c) such provisions, representations, | further contractual document is necessary.
certifications, and specifications, as are attached or |
incorporated by reference herein. (Attachments are listed |
herein.) |
- -----------------------------------------------------------------|------------------------------------------------------------------
19A. NAME AND TITLE OF SIGNER (Type or print) |20A. NAME OF CONTRACTING OFFICER
|
Dennis E. Hruby Chief Scientific Officer |Yvette R. Brown, Contracting Officer, MID RCB-A, OA, DEA, NIAID
- -----------------------------------------------------------------|------------------------------------------------------------------
19B. NAME OF CONTRACTOR |19C. DATE SIGNED |20B. UNITED STATES OF AMERICA |20C. DATE SIGNED
| | |
/s/ Dennis E. Hruby | |BY /s/ Yvette R. Brown |
--------------------------------------- | | ---------------------------------- |
(Signature of person authorized to sign) | 9/26/06 | (Signature of Contracting Officer) | 9/26/06
====================================================================================================================================
NSN 7540-01-152-8069 26-107 STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA
FAR (48 CFR) 53.214(a)
Contract No. HHSN266200600014C
DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS ..................................................................... 4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES ............................................................. 4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE .......................................................................... 4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS ................................................................. 4
ARTICLE B.4. ADVANCE UNDERSTANDINGS ................................................................................ 5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT ................................................................. 7
ARTICLE C.1. STATEMENT OF WORK ..................................................................................... 7
ARTICLE C.2. REPORTING REQUIREMENTS ................................................................................ 7
ARTICLE C.3. INVENTION REPORTING REQUIREMENT ....................................................................... 12
SECTION D - PACKAGING, MARKING AND SHIPPING ........................................................................... 12
SECTION E - INSPECTION AND ACCEPTANCE ................................................................................. 12
SECTION F - DELIVERIES OR PERFORMANCE ................................................................................. 13
ARTICLE F.1. DELIVERIES ............................................................................................ 13
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE ..................................................................... 15
SECTION G - CONTRACT ADMINISTRATION DATA .............................................................................. 15
ARTICLE G.1. PROJECT OFFICER ....................................................................................... 15
ARTICLE G.2. KEY PERSONNEL ......................................................................................... 16
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT ........................... 16
ARTICLE G.4. INDIRECT COST RATES ................................................................................... 16
ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE ....................................................... 17
SECTION H - SPECIAL CONTRACT REQUIREMENTS ............................................................................. 17
ARTICLE H.1. HUMAN SUBJECTS ........................................................................................ 17
ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS ................................... 18
ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS ......................................................... 18
ARTICLE H.4. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES .......................................................... 18
ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH ..................................................... 19
ARTICLE H.6. NEEDLE EXCHANGE ....................................................................................... 19
ARTICLE H.7. PRIVACY ACT ........................................................................................... 19
ARTICLE H.8. ANIMAL WELFARE ........................................................................................ 19
ARTICLE H.9. OMB CLEARANCE ......................................................................................... 20
ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS ........................................................ 20
ARTICLE H.11. PUBLICATION AND PUBLICITY ............................................................................ 20
ARTICLE H.12. PRESS RELEASES ....................................................................................... 20
ARTICLE H.13. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE ................................................... 21
ARTICLE H.14. ANTI -LOBBYING ....................................................................................... 21
ARTICLE H.15. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES ............................................ 21
ARTICLE H.16. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS .................................... 21
ARTICLE H.17. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391) ............................................... 22
ARTICLE H.18. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES ...................................... 23
ARTICLE H.19. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH .... 23
ARTICLE H.20. SHARING RESEARCH DATA ................................................................................ 23
ARTICLE H.21. INTELLECTUAL PROPERTY OPTION TO COLLABORATOR ......................................................... 23
ARTICLE H.22. HUMAN MATERIALS ...................................................................................... 24
ARTICLE H.23. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE) ....................................................... 24
2
Contract No. HHSN266200600014C
PART II - CONTRACT CLAUSES ............................................................................................... 25
SECTION I - CONTRACT CLAUSES .......................................................................................... 25
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT ............................ 25
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES ..................................................................... 28
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES ........................................................................... 28
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT ................................................. 29
PART III-LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS ............................................................... 32
SECTION J - LIST OF ATTACHMENTS ....................................................................................... 32
1. Statement of Work ............................................................................................ 32
2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type
Contracts .................................................................................................... 32
3. Inclusion Enrollment Report .................................................................................. 32
4. Privacy Act System of Records ................................................................................ 31
5. Safety and Health ............................................................................................ 32
6. Procurement of Certain Equipment ............................................................................. 32
7. Research Patient Care Costs .................................................................................. 32
8. Disclosure of Lobbying Activities, SF-LLL .................................................................... 32
9. Commitment To Protect Non-Public Information ................................................................. 32
PART IV .................................................................................................................. 33
SECTION K - REPRESENTATIONS AND CERTIFICATIONS ........................................................................ 33
1. Annual Representations and Certifications .................................................................... 33
2. Human Subjects Assurance Identification Number ............................................................... 33
3. Animal Welfare Assurance Number .............................................................................. 33
3
Contract No. HHSN266200600014C
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this contract is to advance development of SIGA-246 as a novel
therapeutic agent for the treatment of smallpox and related orthopoxviruses.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this contract is $15,908,190.
b. The fixed fee for this contract is $636,327. The fixed fee shall be paid
in installments based on the percentage of completion of work, as
determined by the Contracting Officer, and subject to the withholding
provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE
referenced in the General Clause Listing in Part II, ARTICLE I.1. of this
contract. Payment of fixed fee shall not be made in less than monthly
increments.
c. The Government's obligation, represented by the sum of the estimated cost
plus fixed fee, is $16,544,517.
d. Total funds currently available for payment and allotted to this contract
are $8,191,538, of which $8,068,787 represents the estimated costs, and of
which $122,751 represents the fixed fee. For further provisions on
funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE
I.2. Authorized Substitutions of Clauses.
e. It is estimated that the amount currently allotted will cover performance
of the contract through September 19, 2007.
f. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
g. Future increments to be allotted to this contract are estimated as
follows:
FISCAL YEAR PERIOD COST FEE TOTAL AMOUNT
----------- ----------------- ---------- -------- ------------
2007 09/20/07-09/28/08 $4,969,280 $398,771 $ 5,368,051
2008 09/29/08-09/28/09 $2,870,123 $114,805 $ 2,984,928
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel - See subparagraph b. below;
4
Contract No. HHSN266200600014C
(6) Consultant costs;
(7) Subcontracts;
(8) Patient care costs;
(9) Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life
expectancy of more than two years) and "sensitive items" (defined
and listed in the Contractor's Guide for Control of Government
Property), 1990, regardless of acquisition value.
(10) Light Refreshments and Meal Expenditures
Requests to use contract funds to provide light refreshments and/or
meals to either federal or non-federal employees must be submitted
to the project officer, with a copy to the contracting officer, at
least six (6) weeks in advance of the event. The request shall
contain the following information: (a) name, date, and location of
the event at which the light refreshments and/or meals will be
provided; (b) a brief description of the purpose of the event; (c) a
cost breakdown of the estimated light refreshment and/or meal costs;
(d) the number of non-federal and federal attendees receiving light
refreshments and/or meals; and (e) if the event will be held
somewhere other than a government facility, provide an explanation
of why the event is not being held at a government facility.
Refer to NIH Manual Chapter 1160-1, Entertainment, for more
information on NIH's policy on the use of appropriated funds for
light refreshments and meals.
b. Travel Costs
(1) Domestic Travel
(a) Total expenditures for domestic travel (transportation,
lodging, subsistence, and incidental expenses) incurred in
direct performance of this contract shall not exceed $58,630
without the prior written approval of the Contracting Officer.
(b) The Contractor shall invoice and be reimbursed for all travel
costs in accordance with Federal Acquisition Regulations (FAR)
31.205-46.
(2) Foreign Travel
Requests for foreign travel must be submitted at least six weeks in
advance and shall contain the following: (a) meeting(s) and place(s)
to be visited, with costs and dates; (b) name(s) and title(s) of
Contractor personnel to travel and their functions in the contract
project; (c) contract purposes to be served by the travel; (d) how
travel of contractor personnel will benefit and contribute to
accomplishing the contract project, or will otherwise justify the
expenditure of NIH contract funds; (e) how such advantages justify
the costs for travel and absence from the project of more than one
person if such are suggested; and (f) what additional functions may
be performed by the travelers to accomplish other purposes of the
contract and thus further benefit the project.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.
a. Subcontracts
To negotiate the following cost reimbursement type subcontracts for an
amount not to exceed $11,005,000. Award of the subcontracts shall not
proceed without the prior written approval of the Contracting Officer upon
review of the supporting documentation as required by the Subcontracts
clause of the General Clauses
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Contract No. HHSN266200600014C
incorporated in this contract. (After written approval of the subcontracts
by the Contracting Officer, a copy of each of the signed, approved
subcontract shalls be provided to the Contracting Officer.):
(1) Advanced Biologics not to exceed $7,425,000
(2) Cedarburg not to exceed $1,398,000
(3) DSM not to exceed $1,000,000
(4) Metrics not to exceed $150,000
(5) MPI Research not to exceed $1,032,000
b. Consultants
Consultant fees to be paid to the following individuals:
Rate
Per Number of Hours Total Cost
Name Hour Not to Exceed Including Travel Not to Exceed
-------------------------------------------------------------------------------------
Dr. Josef Strasser $ 175.00 333 $61,475
External Advisory - TBD $ 350.00 270 $78,000
c. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated
Budget
(1) The contractor agrees to provide a detailed breakdown on invoices of
the following cost categories:
(a) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount claimed
(b) Fringe Benefits - Cite rate and amount
(c) Overhead - Cite rate and amount
(d) Materials & Supplies - Include detailed breakdown when total
amount is over $1,000
(e) Travel - Identify travelers, dates, destination, purpose of
trip, and amount. Cite COA, if appropriate List separately,
domestic travel, general scientific meeting travel, and
foreign travel
(f) Consultant Fees - Identify individuals and amounts
(g) Subcontracts - Attach subcontractor invoice(s)
(h) Equipment - Cite authorization and amount
(i) G&A - Cite rate and amount
(j) Total Cost
(k) Fixed Fee
(l) Total CPFF
Monthly invoices must include the cumulative total expenses to date,
adjusted (as applicable) to show any amounts suspended by the
government.
(2) The contractor agrees to immediately notify the contracting officer
in writing if there is an anticipated overrun (any amount) or
unexpended balance (greater than 10 percent) of the amount allotted
to the contract, and the reasons for the variance. Also refer to the
requirements of the Limitation of Funds and Limitation of Cost
Clauses in the contract.
d. Publications
Any manuscript or scientific meeting abstract containing data generated
under this contract must be submitted for NIAID Project Officer review no
less than thirty (30) calendar days for manuscripts and fifteen (15)
calendar days for abstracts before submission for public presentation or
publication. Contract support shall be acknowledged in all such
publications. A "publication" is defined as an issue of printed material
offered for distribution or any communication or oral presentation of
information. The NIAID Project Officer will review all manuscripts and
abstracts in a period of time not to exceed thirty (30) calendar days for
manuscripts and fifteen
6
Contract No. HHSN266200600014C
(15) calendar days for abstract from receipt, and will either agree to the
publication/disclosure or recommend changes.
e. Contract Number Designation
On all correspondence submitted under this contract, the contractor agrees
to clearly identify the two contract numbers that appear on the face page
of the contract as follows:
Contract No. HHSN266200600014C
ADB Contract No. N01-AI-60014.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government as
needed to perform the Statement of Work, dated, September 29, 2006, set
forth in SECTION J-List of Attachments, attached hereto and made a part of
this contract.
b. The following described document is attached hereto and hereby made a part
of this contract: (SEE SECTION J-List of Attachments.)
Document Title Date Description of Document
- ------------------------ --------- -------------------------------------
NDA Enabling Development
for SIGA-246: A Smallpox
Antiviral Drug SIGA Technologies Proposed Statement
BAA NIH-NIAID-DMID-06-35 9/29/2006 of Work and Deliverables
c. If there is any inconsistency between the attached portion of the
proposal, identified in subparagraph b. above, and the work described in
subparagraph a. of this ARTICLE, the terms and conditions of subparagraph
a. of this ARTICLE shall control.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format. In
addition, one (1) hard copy of each report shall be submitted to the Contracting
Officer, unless otherwise specified herein.
a. Progress Reports
In addition to the required reports set forth elsewhere in this Schedule, the
preparation and submission of regularly recurring Technical Progress Reports
will be required in any contract resulting from this solicitation. These reports
will require descriptive information about the activities undertaken during the
reporting period and will require information about planned activities for
future reporting periods. The frequency and specific content of these reports
will be determined prior to contract award.
1) Monthly Technical Progress Reports
On the 15th of each month, the Contractor shall submit a Monthly Technical
Progress Report that includes the following:
a) A Cover page that includes the contract number and title; the
type of report and period that it covers; the Contractor's name,
address, telephone number, fax number, and email address; and the
date of submission;
7
Contract No. HHSN266200600014C
b) SECTION I - An Introduction covering the purpose and scope of the
contract effort;
c) SECTION II - PROGRESS
i) SECTION II Part A: OVERALL PROGRESS - A description of
overall progress;
ii) SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE -
A description of all meetings, conference calls, etc. that
have taken place during the reporting period. Include progress
on administration and management issues (e.g. evaluating, and
managing subcontractor performance);
iii) SECTION II Part C: TECHNICAL PROGRESS - For each activity
document the results of work completed and cost incurred
during the period covered in relation to proposed progress,
effort and budget. The report shall be in sufficient detail to
explain comprehensively the results achieved. The description
shall include pertinent data and/or graphs in sufficient
detail to explain any significant results achieved and
preliminary conclusions resulting from analysis and scientific
evaluation of data accumulated to date under the contract. The
report shall include a description of problems encountered and
proposed corrective action; differences between planned and
actual progress, why the differences have occurred and what
corrective actions are planned; preliminary conclusions
resulting from analysis and scientific evaluation of data
accumulated to date under the project;
iv) SECTION II Part D: PROPOSED WORK - A summary of work
proposed for the next reporting period; and
v) Preprints and reprints of papers and abstracts.
A Monthly Technical Progress Report will not be required in the same month
that the Annual Technical Progress Report is submitted.
2) Annual Technical Progress Reports
Annual Technical Progress Reports shall be submitted by the 15th of the
month following the end of each 12 months of the contract performance
period. Each Annual Report shall include:
a) A Cover page that includes the contract number and title; the type of
report and period that it covers; the Contractor's name, address,
telephone number, fax number, and email address; and the date of
submission;
b) SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed,
and the major accomplishments achieved during the current reporting
period;
c) SECTION II: PROGRESS
i) SECTION II Part A: OVERALL PROGRESS - A description of
overall progress;
ii) SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE -
A description of all meetings, conference calls, etc. that
have taken place during the reporting period. Include progress
on administration and management issues (e.g. evaluating, and
managing subcontractor performance; regulatory compliance
audits);
iii) SECTION II Part C: TECHNICAL PROGRESS - A detailed
description of the work performed structured to follow the
activities and decision gates outlined in the approved
Strategic Staged Product Development Plan. Any problems
(technical or financial) that occurred or were identified
during the reporting period, and how these problems were
resolved;
iv) SECTION II Part D: PROPOSED WORK - A summary of work
proposed for the next year period.
v) Copies of manuscripts (published and unpublished),
abstracts, and any protocols or methods developed specifically
under the contract during the reporting period; and
vi) A summary of any inventions developed during the course of
the contract.
3) Draft Final Technical Progress Report and Final Technical Progress
Report
The Final Technical Report shall document and summarize the results of the
entire contract period of performance. This report shall be submitted
sixty (60) calendar days before the completion date of the contract. The
report shall conform to the following format:
(1) Cover page to include the contract number, contract title,
performance period covered, Contractor's name and address, telephone
number, fax number, email address and submission date;
b) SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of
the contract effort including
8
Contract No. HHSN266200600014C
a summary of the major accomplishments relative to the specific
activities set forth in the Statement of Work.
c) SECTION II: RESULTS - A detailed description of the work performed,
the results obtained, and the impact of the results on the
scientific and/or public health community, including a listing of
all manuscripts (published and in preparation) and abstracts
presented during the entire period of performance, and a summary of
all inventions.
Draft Final Technical Progress Report: The Contractor is required to
submit the Draft Final Technical Progress Report to the Project Officer
and Contracting Officer. This report is due 120 calendar days before the
completion date of the contract. The Project Officer and Contracting
Officer will review the Draft Final Technical Progress Report and provide
the Contractor with comments within 45 calendar days after receipt.
Final Technical Progress Report: The Contractor will deliver the final
version of the Final Progress Technical Report as specified in the Article
F.1.
Summary of Salient Results: The Contractor will be required to prepare and
submit, with the Final Technical Progress Report, a summary of salient
results (not to exceed 200 words) of salient results achieved during the
performance of the contract. This report will be required on or before the
expiration date of the contract.
b. Technical Reports
1) Decision Gate Report
A Decision Gate Report shall be submitted when the Contractor has
completed a stage of product development and has reached a Go/No Go
decision point, as defined in the approved Strategic Staged Product
Development Plan. These reports shall be in sufficient detail to explain
comprehensively the results achieved. The description shall also include
pertinent data and/or conclusions resulting from the analysis and
scientific evaluation of data accumulated to date under the project.
Decision Gate Reports shall include the following specific information:
a) 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;
b) An introduction covering the purpose, the scope of the contract
effort, and the specific Decision Gate that has been reached;
c) 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;
d) Actual costs incurred in relation to costs estimated in the original
approved budget; and
e) A description of the next stage of product development to be
initiated and a request for NIAID approval to proceed to the next
stage of product development.
2) Decision Gate Change or Deviation Request
The Contractor shall submit a written request for a change in the agreed
time lines and/or decision gate as approved in the Strategic Staged
Product Development Plan. This request shall include the following:
a) A discussion of the justification/rationale for the request based on
current data and a description of those data;
b) Options for addressing the needed change/deviation from the approved
time lines and/or decision gates, including a cost-benefit analysis
of each option; and
c) 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, time lines, and budget.
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Contract No. HHSN266200600014C
3) Audit Reports
Within thirty (30) calendar days of an audit related to conformance to FDA
regulations and guidance, including adherence to GLP, GMP or GCP
guidelines, the Contractor shall provide copies of the audit report and a
plan for addressing areas of nonconformance to FDA regulations and
guidance for GLP, GMP or GCP guidelines as identified in the final audit
report.
4) Clinical Trial Protocols
The NIAID has a responsibility to ensure that mechanisms and procedures
are in place to protect the safety of participants in NIAID-funded
clinical trials. Therefore, as described in the NIAID Clinical Terms of
Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), the Contractor
shall develop a protocol for each clinical trial and submit all protocols
and protocol amendments for approval by the NIAID Project Officer.
Protocols must be submitted using the approved DMID template and include a
sample Informed Consent and Clinical Trials Monitoring Plan. The DMID
templates and other important information regarding performing human
subjects research are available at
(http://www.niaid.nih.gov/dmid/clinresearch/). These updates are to be
included in the Monthly Technical Progress Report.
5) Final Clinical Study Report
The Final Clinical Study Report shall follow the ICH guidelines on
Structure and Content of Clinical Study Reports E3
(http://www.pharmacontract.ch/support/su_ich_liste.htm). Final Clinical
Study Reports shall be provided within thirty (30) calendar days of the
completion of the analysis of all data generated in the clinical trial.
6) Final Animal Efficacy Study Report
The Final Animal Efficacy Study Report shall include a complete
description of the experimental design, protocol, methods, reagents, data
analysis, and conclusions of studies performed to demonstrate efficacy of
therapeutic product for the indication (i.e., post-exposure prophylaxis or
treatment) being sought.
c. Other Reports
1) Strategic Staged Product Development Plan
Within fourteen (14) calendar days of contract award and prior to
initiation of product development activities, unless otherwise negotiated
with the NIAID Project Officer and the NIAID Contracting Officer, the
Contractor shall submit for approval the Strategic Staged Product
Development Plan. This Plan shall include:
a) Clearly defined goals, product development stages and product
development activities;
b) Go/No Go decision gates;
c) Quantitative and qualitative criteria for assessing the
scientific merit and feasibility of moving to the next stage of
product development; and
d) A detailed time line for each stage covering the initiation,
conduct and completion of product development activities, the
analysis of outcomes and findings, and the preparation of detailed
reports summarizing the results of work completed and an analysis of
the data as it relates to the qualitative and quantitative criteria
established for Go/No Go decision-making.
2) Annual Review Meeting Reports
A report of the post-award kick-off meeting and the annual review meetings
shall be prepared by the Contractor and submitted within twenty-one (21)
calendar days following the date of the meeting. This report shall include
the slide presentations and all other meeting materials as well as
summaries of all discussions.
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Contract No. HHSN266200600014C
3) Copies of FDA Correspondence and Meeting Summaries
Within thirty (30) calendar days of receiving correspondence or meeting
with the FDA, submit copies of the correspondence or meeting
minutes/summaries to the NIAID Project Officer.
4) Annual Technical Progress Report for Clinical Research Study
Populations
The Contractor shall submit information about the inclusion of women and
members of minority groups and their sub populations for each study being
performed under this contract. The contractor shall submit this
information in the format indicated in the attachment entitled, "Inclusion
Enrollment Report," which is set forth in Section J of this contract. The
contractor also shall use this format, modified to indicate that it is a
final report, for reporting purposes in the final report.
The contractor shall submit the report in accordance with ARTICLE F.1.
DELIVERIES of this contract. In addition, the NIH Policy and Guidelines on
the Inclusion of Women and Minorities as Subjects in Clinical Research,
Amended, October, 2001 applies. If this contract is for Phase III clinical
trials, see II.B of these guidelines. The Guidelines may be found at the
following website:
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
Include a description of the plans to conduct analyses, as appropriate, by
sex/gender and/or racial/ethnic groups in the clinical trial protocol as
approved by the IRB, and provide a description of the progress in the
conduct of these analyses, as appropriate, in the annual progress report
and the final report. If the analysis reveals no subset differences, a
brief statement to that effect, indicating the subsets analyzed, will
suffice. The Government strongly encourages inclusion of the results of
subset analysis in all publication submissions. In the final report, the
contractor shall include all final analyses of the data on sex/gender and
race/ethnicity.
5) Sample of Therapeutics
The Contractor shall submit to NIAID samples of candidate drug
therapeutics and GMP material manufactured with NIAID contract funding.
Fifty (50) doses of drug substance will be provided to NIH (assuming that
500 mg is the selected dose, 25 g will be provided). Fifty (50) doses of
SIGA-246 drug product, strength to be determined, will be provided to NIH.
The Contractor will be advised by the NIAID Project Officer how samples
are to be packaged and where samples are to be shipped.
6) Animal Models
Technology Transfer packages that include complete protocols and critical
reagents for animal models developed and/or improved with contract funding
must be submitted at the request of the NIAID Project Officer.
7) Copies of other reports generated during the contract period related to
performance of the contract, including: Process Development Reports,
Qualification Plan/Report, Validation Plan/Report, Batch Records, SOPs,
Master Production Records, Certificate of Analysis at the request of the
NIAID Project Officer.
8) Institutional BioSafety Approval
The Contractor shall provide documentation of materials submitted for
Institutional Biosafety Committee Review and documentation of approval of
experiments at the request of the NIAID Project Officer.
9) Data
Provide raw data or specific analysis of data generated with contract
funding at the request of the NIAID Project Officer.
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Contract No. HHSN266200600014C
ARTICLE C.3. INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR Clause 52.227-13 including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Extramural
Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986).
In addition, one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer. The final
invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted to the
Contracting Officer on the expiration date of the contract.
The annual utilization report shall be submitted in accordance with the
DELIVERIES Article in SECTION F of this contract. The final invention statement
(see FAR 27.303(a)(2)(ii)) shall be submitted on the expiration date of the
contract. All reports shall be sent to the following address:
Contracting Officer
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Office of Acquisition
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, Maryland 20892 -7612
If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the address listed above.
To assist contractors in complying with invention reporting requirements of the
clause, the NIH has developed "Interagency Edison," an electronic invention
reporting system. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (http://www.iedison.gov), or by
contacting the Extramural Inventions and Technology Resources Branch, OPERA,
NIH.
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and contractor name. The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.
b. For the purpose of this SECTION the designated Project Officer is the
authorized representative of the Contracting Officer.
c. Inspection and acceptance will be performed at:
Division of Microbiology and Infectious Diseases, NIAID, NIH
6610 Rockledge Drive; Bethesda, MD 20892
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
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Contract No. HHSN266200600014C
d. This contract incorporates the following clause by reference, with the
same force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR Clause 52.246-5, Inspection Of Services--Cost Reimbursement (April
1984).
FAR Clause 52.246-8, Inspection Of Research And Development--Cost
Reimbursement (May 2001).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in the STATEMENT OF WORK Article in SECTION C
of this contract and upon delivery and acceptance by the Contracting Officer, or
the duly authorized representative, of the following items in accordance with
the stated delivery schedule:
a. The items specified below as described in the REPORTING REQUIREMENTS
Article in SECTION C of this contract. will be required to be delivered
F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION,
WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the
date(s) specified below:
- -----------------------------------------------------------------------------------------------------
Item No. of Addresses/
No. Type of Report Copies Distribution Due Date
-----------------------------------------------------------------------------------------------
PROGRESS REPORTS
- -----------------------------------------------------------------------------------------------------
1. Monthly Technical 3 paper Original hard copy The 15th of each month
Progress Report 2 electronic and one (1) following the first full
electronic copy: month of contract award.
Contracting Officer The monthly report will
Two (2) paper and one not be required on months
(1) electronic: when an Annual
Project Officer Technical Report is due.
- -----------------------------------------------------------------------------------------------------
2. Annual Technical 3 paper Same as CO and PO 15th of the month following
Progress Report 2 electronic above the end of each 12 months
of the performance period.
- -----------------------------------------------------------------------------------------------------
3. Final Technical Progress 3 paper Same as CO and PO Sixty (60) calendar days
Report 2 electronic above prior to completion date of
the contract
- -----------------------------------------------------------------------------------------------------
TECHNICAL REPORTS
- -----------------------------------------------------------------------------------------------------
4. Decision Gate Report 3 paper Same as CO and PO Following completion of a
2 electronic above pre-defined stage of
product development and
prior to initiation of a
new stage.
- -----------------------------------------------------------------------------------------------------
5. Decision Gate Change or 3 paper Same as CO and PO As soon as the Contractor
Deviation Request 2 electronic above. has sufficient data to
support the need for a
change from the approved
Strategic Staged Product
Development Plan.
- -----------------------------------------------------------------------------------------------------
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Contract No. HHSN266200600014C
- -----------------------------------------------------------------------------------------------------
6. Audit Reports 3 paper Same as CO and PO Within 30 calendar days
2 electronic above. of the audit.
- -----------------------------------------------------------------------------------------------------
7. Clinical Trials Protocols 3 paper Same as PO above To be negotiated with the
2 electronic NIAID Project Officer and
prior to IND submission or
enrollment of human
subjects.
- -----------------------------------------------------------------------------------------------------
8. Final Clinical Study 3 paper Same as CO and PO Thirty (30) calendar days
Report 2 electronic above of completion of analysis
of clinical trial data.
- -----------------------------------------------------------------------------------------------------
9. Final Animal Efficacy 3 paper Same as CO and PO Thirty (30) calendar days
Study Reports 2 electronic above of completion of all
analysis of animal
efficacy study data.
- -----------------------------------------------------------------------------------------------------
OTHER REPORTS
- -----------------------------------------------------------------------------------------------------
10. Strategic Staged Product 3 paper Same as CO and PO Within fourteen (14)
Development Plan 2 electronic above calendar days of contract
award and prior to
initiation of product
development activities
- -----------------------------------------------------------------------------------------------------
11. Annual Review Meeting 3 paper Same as CO and PO Within twenty-one (21)
Report 2 electronic above calendar days following
the date of the Annual
Review Meeting.
- -----------------------------------------------------------------------------------------------------
12. FDA Correspondence and 3 paper Same as PO above Within thirty (30) calendar
Meeting Summaries 2 electronic days of receiving
correspondence or
meeting with the FDA.
- -----------------------------------------------------------------------------------------------------
13. Technical Progress Report 2 paper Original paper and Due on/before the 30th of
for Clinical Research 1 electronic one (1) electronic to the month following each
Study Populations CO anniversary of the contract.
Two (2) paper and
one (1) electronic to
PO
- -----------------------------------------------------------------------------------------------------
14. Invention Report - Annual 1 paper Original paper and Due on/before the 30th of
Utilization Report 1 electronic one (1) electronic to the month following each
OPERA anniversary of the contract.
One (1) paper to CO
- -----------------------------------------------------------------------------------------------------
15. Final Invention Statement 2 paper Original paper and Due on/before the
1 electronic one (1) electronic to completion date of the
OPERA contract.
One (1) paper to CO
- -----------------------------------------------------------------------------------------------------
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Contract No. HHSN266200600014C
b. The above items shall be addressed and delivered to:
- --------------------------------------------------------------------------------
Addressee Deliverable Item No. Quantity
- --------------------------------------------------------------------------------
Contracting Officer 1. to 15. Original paper and one (1)
electronic
- --------------------------------------------------------------------------------
Project Officer 1. to 13. Two (2) paper and one (1)
electronic
- --------------------------------------------------------------------------------
EITRB, Office of 14. and 15. Original paper and one (1)
Biodefense Research electronic
Affairs, NIH
- --------------------------------------------------------------------------------
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause(s) by reference, with the same
force and effect as if it were given in full text. Upon request, the Contracting
Officer will make its full text available. Also, the full text of a clause may
be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose
of this contract:
Primary: Helen Schiltz, Ph.D.
Program Officer, BioDefense Drug Development Section
Office of Biodefense Research Affairs
Division of Microbiology and Infectious Diseases, NIAID, NIH, DHHS
6610 Rockledge Drive, Room 5107
Bethesda, MD 20892
301-451-3245
Hschiltz@niaid.nih.gov
The Project Officer is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance and
recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
The Contracting Officer is the only person with authority to act as agent of the
Government under this contract. Only the Contracting Officer has authority to:
(1) direct or negotiate any changes in the Statement of Work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.
The Government may unilaterally change its Project Officer designation.
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Contract No. HHSN266200600014C
ARTICLE G.2. KEY PERSONNEL
Pursuant to HHSAR Clause 352.270-5, Key Personnel, incorporated in Section I of
this contract, the following individual(s) is/are considered to be essential to
the work being performed hereunder:
Name Title
- --------------------------------------------------------------------------------
Dennis E. Hruby, Ph.D. Principal Investigator
Prior to diverting any of the specified individuals to other programs, the
Contractor shall notify the Contracting Officer reasonably in advance and shall
submit justification (including proposed substitutions) in sufficient detail to
permit evaluation of the impact on the program. No diversion shall be made by
the Contractor without the written consent of the Contracting Officer; provided,
that the Contracting Officer may ratify in writing such diversion and such
ratification shall constitute the consent of the Contracting Officer. The
contract may be modified from time to time during the course of the contract to
either add or delete personnel, as appropriate
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT
a. Invoice/Financing Request Instructions and Contract Financial Reporting
for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made
part of this contract. The instructions and the following directions for
the submission of invoices/financing request must be followed to meet the
requirements of a "proper" payment request pursuant to FAR 32.9.
These instructions also provide for the submission of financial and
personnel reporting required by HHSAR 342.7002.
(1) Invoices/financing requests shall be submitted as follows:
(a) To be considered a "proper" invoice in accordance with FAR
32.9, each invoice shall clearly identify the two contract
numbers that appear on the face page of the contract as
follows:
Contract No. HHSN266200600014C
ADB Contract No. N01-AI-60014
(b) An original and two copies to the following designated billing
office:
Contracting Officer
Office of Acquisitions
National Institute of Allergy and Infectious Diseases, NIH
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612
(2) Inquiries regarding payment of invoices should be directed to
the designated billing office, (301) 496-0612.
ARTICLE G.4. INDIRECT COST RATES
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in PART II, SECTION I, the cognizant Contracting Officer
representative responsible for negotiating provisional and/or final indirect
cost rates is identified as follows:
Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 Executive Blvd. MSC-7540
Bethesda, MD 20892-7540
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Contract No. HHSN266200600014C
These rates are hereby incorporated without further action of the Contracting
Officer.
ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
a. Contractor Performance Evaluations
Interim and final evaluations of contractor performance will be prepared
on this contract in accordance with FAR 42.15. The final performance
evaluation will be prepared at the time of completion of work. In addition
to the final evaluation, interim evaluations will be prepared annually to
coincide with the anniversary date of the contract.
Interim and final evaluations will be provided to the Contractor as soon
as practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. If agreement cannot be reached
between the parties, the matter will be referred to an individual one
level above the Contracting Officer, whose decision will be final.
Copies of the evaluations, contractor responses, and review comments, if
any, will be retained as part of the contract file, and may be used to
support future award decisions.
b. Electronic Access to Contractor Performance Evaluations
Contractors that have Internet capability may access evaluations through a
secure Web site for review and comment by completing the registration form
that can be obtained at the following address:
http://oamp.od.nih.gov/OD/CPS/cps.asp
The registration process requires the contractor to identify an individual
that will serve as a primary contact and who will be authorized access to
the evaluation for review and comment. In addition, the contractor will be
required to identify an alternate contact who will be responsible for
notifying the cognizant contracting official in the event the primary
contact is unavailable to process the evaluation within the required
30-day time frame.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. HUMAN SUBJECTS
Research involving human subjects shall not be conducted under this contract
until the protocol developed in Phase I has been approved by the NIAID, written
notice of such approval has been provided by the Contracting Officer, and the
Contractor has provided to the Contracting Officer a properly completed
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the protocol. The human
subject certification can be met by submission of the Contractor's self
designated form, provided that it contains the information required by the
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly
Optional Form 310).
When research involving Human Subjects will take place at collaborating sites or
other performance sites, the Contractor shall obtain, and keep on file, a
properly completed "Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the research.
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Contract No. HHSN266200600014C
ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators receiving NIH contract awards for research involving human
subjects. For a complete description of the NIH Policy announcement on required
education in the protection of human subject participants, the contractor should
access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at
the following web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
The information below is a summary of the NIH Policy Announcement:
The contractor shall maintain the following information: (1) a list of the names
and titles of the principal investigator and any other individuals working under
the contract who are responsible for the design and/or conduct of the research;
(2) the title of the education program(s) in the protection of human subjects
that has been completed for each named personnel and; (3) a one sentence
description of the educational program(s) listed in (2) above. This requirement
extends to investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or consultants under
the contract.
Prior to any substitution of the Principal Investigator or any other individuals
responsible for the design and/or conduct of the research under the contract,
the contractor shall provide the following written information to the
Contracting Officer: the title of the education program and a one sentence
description of the program that has been completed by the replacement.
ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS
The contractor is directed to the full text of the NIH Policy regarding Data and
Safety Monitoring and Reporting of Adverse Events, which may be found at the
following web sites:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
The contractor must comply with the NIH Policy cited in these NIH Announcements
and any other data and safety monitoring requirements found elsewhere in this
contract.
Data and Safety Monitoring shall be performed in accordance with the approved
Data and Safety Monitoring Plan.
The Data and Safety Monitoring plan shall be established and approved prior to
beginning the conduct of the clinical trial.
ARTICLE H.4. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene
Transfer Research)
All research involving Recombinant DNA Molecules shall be conducted in
accordance with the NIH Guidelines for Research Involving Recombinant DNA
Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) and the
May 28, 2002 Notice, Compliance with the NIH Guidelines for Research Involving
Recombinant DNA Molecules
(http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html) (and any
subsequent revisions to the Guide Notice) which stipulates biosafety and
containment measures for recombinant DNA research and delineates critical,
ethical principles and key safety reporting requirements for human gene transfer
research (See Appendix M of the Guidelines). These guidelines apply to both
basic and clinical research studies.
The Recombinant DNA Advisory Committee (RAC) is charged with the safety of
manipulation of genetic material through the use of recombinant DNA techniques.
Prior to beginning any clinical trials involving the transfer of recombinant DNA
to humans, the trial must be registered with the RAC. If this contract involves
new protocols that contain unique and//or novel issues, the RAC must discuss
them in a public forum and then the Institutional Biosafety Committee (IBC), the
Institutional Review Board (IRB), and the project officer and contracting
officer must approve
18
Contract No. HHSN266200600014C
the protocol prior to the start of the research.
Failure to comply with these requirements may result in suspension, limitation,
or termination of the contract for any work related to Recombinant DNA Research
or a requirement for contracting officer prior approval of any or all
Recombinant DNA projects under this contract. This includes the requirements of
the Standing Institutional Biosafety Committee (IBC) (See
http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm ).
As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious adverse
event must be reported immediately to the IRB, the IBC, the Office for Human
Research Protections (if applicable), and the NIH Office for Biotechnology
Activities (OBA), followed by the filing of a written report with each
office/group and copies to the project officer and contracting officer.
(http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255836)
ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law(s) cited in paragraph b. , below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos
for research purposes; or (2) research in which a human embryo or embryos
are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero under 45
CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42
U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism,
not protected as a human subject under 45 CFR 46 as of the date of the
enactment of this Act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes or human
diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
b. Public Law and Section No. Fiscal Year Period Covered
P.L. 109-149, Title V-General 2006 (10/1/2005-9/30/2006)
Provisions Section 509
ARTICLE H.6. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds
shall not be used to carry out any program of distributing sterile needles
or syringes for the hypodermic injection of any illegal drug.
b. Public Law and Section No. Fiscal Year Period Covered
P.L. 109-149, Title V-General 2006 (10/1/2005-9/30/2006)
Provisions Section 505
ARTICLE H.7 . PRIVACY ACT
This procurement action requires the Contractor to do one or more of the
following: design, develop, or operate a system of records on individuals to
accomplish an agency function in accordance with the Privacy Act of 1974, Public
Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations.
Violation of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records applicable to this project is Number
09-25-0200. This document is incorporated into this contract as an Attachment in
SECTION J of this contract.
ARTICLE H.8. ANIMAL WELFARE
All research involving live, vertebrate animals shall be conducted in accordance
with the Public Health Service Policy on Humane Care and Use of Laboratory
Animals. This policy may be accessed at:
http://grants1.nih.gov/grants/olaw/references/phspol.htm
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Contract No. HHSN266200600014C
ARTICLE H.9. OMB CLEARANCE
In accordance with HHSAR 352.270-7, Paperwork Reduction Act, the Contractor
shall not proceed with surveys or interviews until such time as Office of
Management and Budget (OMB) Clearance for conducting interviews has been
obtained by the Project Officer and the Contracting Officer has issued written
approval to proceed.
ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to the P.L.(s) cited in paragraph b., below, no NIH Fiscal Year
funds may be used to pay the direct salary of an individual through this
contract at a rate in excess of the applicable amount shown or the
applicable Executive Level for the fiscal year covered. Direct salary is
exclusive of fringe benefits, overhead and general and administrative
expenses (also referred to as "indirect costs" or "facilities and
administrative (F&A) costs"). Direct salary has the same meaning as the
term "institutional base salary." An individual's direct salary (or
institutional base salary) is the annual compensation that the contractor
pays for an individual's appointment whether that individual's time is
spent on research, teaching, patient care or other activities. Direct
salary (or institutional base salary) excludes any income that an
individual may be permitted to earn outside of duties to the contractor.
The per year salary rate limitation also applies to individuals proposed
under subcontracts. It does not apply to fees paid to consultants. If this
is a multiple year contract, it may be subject to unilateral modifications
by the Government if an individual's salary rate used to establish
contract funding exceeds any salary rate limitation subsequently
established in future HHS appropriation acts.
b. Public Law No. Fiscal Year Dollar Amount of Salary Limitation
P.L. 109-149, Public FY 06 Executive Level I
Health & Social Services
Emergency Fund General
Provisions, Section 204
c. Payment of direct salaries is limited to the Executive Level I* rate which
was in effect on the date(s) the expense was incurred.
For the period 10/1/05 - 12/31/05, the Executive Level I rate is $180,100.
Effective January 1, 2006, the Executive Level I rate increased to
$183,500 and will remain at that rate until it is revised. See the web
site listed below for the Executive Schedule rates of pay:
FOR FY-06 EXECUTIVE LEVEL SALARIES EFFECTIVE JANUARY 1, 2006:
http://www.opm.gov/oca/06tables/html/ex.asp
(Note: This site shows the FY-06 rates. For previous years, click on
"salaries and wages" and then scroll down to the bottom of the page and
click on the year to locate the desired Executive Level salary rates.)
ARTICLE H.11. PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from
the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Department of Health and Human Services, under
Contract No.HHSN266200600014C."
ARTICLE H.12. PRESS RELEASES
a. Pursuant to Public Law(s) cited in paragraph b., below, the contractor
shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (1) the percentage
of the total costs of the program or project which will be financed with
Federal money; (2) the dollar amount of Federal funds for the project or
program; and (3) the percentage and dollar amount of the total costs of
the project or program that will be financed by non governmental sources.
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Contract No. HHSN266200600014C
b. Public Law and Section No. Fiscal Year Period Covered
P.L. 109-149, Title V-General 2006 (10/1/2005-9/30/2006)
Provisions Section 506
ARTICLE H.13. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE P.O. Box 23489
Washington, D.C. 20026
ARTICLE H.14. ANTI -LOBBYING
a. Pursuant to Public Law(s) cited in paragraph c., below, contract funds
shall only be used for normal and recognized executive-legislative
relationships. Contract funds shall not be used, for publicity or
propaganda purposes; or for the preparation, distribution, or use of any
kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support or defeat legislation pending before the
Congress or any State legislature, except in presentation to the Congress
or any State legislature itself.
b. Contract funds shall not be used to pay salary or expenses of the
contractor or any agent acting for the contractor, related to any activity
designed to influence legislation or appropriations pending before the
Congress or any State legislature.
c. Public Law and Section No. Fiscal Year Period Covered
for a., above: P.L. 109-149, Title FY-06 (10/1/2005-9/30/2006)
V-General Provisions
Section 503a.
for b., above: P.L. 109-149, Title FY-06 (10/1/2005-9/30/2006)
V-General Provisions
Section 503b.
ARTICLE H.15. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Unique research resources arising from NIH-funded research are to be shared with
the scientific research community. NIH provides guidance, entitled, "Sharing
Biomedical Research Resources: Principles and Guidelines for Recipients of NIH
Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64
FR 72090]), concerning the appropriate terms for disseminating and acquiring
these research resources. This guidance, found at :
http://ott.od.nih.gov/NewPages/64FR72090.pdf. is intended to help contractors
ensure that the conditions they impose and accept on the transfer of research
tools will facilitate further biomedical research, consistent with the
requirements of the Bayh-Dole Act and NIH funding policy.
Note: For the purposes of this Article, the terms, "research tools," "research
materials," and "research resources" are used interchangeably and have the same
meaning.
ARTICLE H.16. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
The contractor shall not conduct work involving select agents or toxins under
this contract until it and any associated subcontractor(s) comply with the
following:
For prime or subcontract awards to domestic institutions that possess,
use, and/or transfer Select Agents under this contract, the institution
must comply with the provisions of 42 CFR part 73, 7 CFR part 331, and/or
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Contract No. HHSN266200600014C
9 CFR part 121
(http://www.aphis.usda.gov/programs/ag_selectagent/ FinalRule3-18-05.pdf),
as required, before using NIH funds for research involving Select Agents.
No NIH funds can be used for research involving Select Agents if the final
registration certificate is denied.
For prime or subcontract awards to foreign institutions that possess, use,
and/or transfer Select Agents under this contract, before using NIH funds
for any work directly involving the Select Agents, the foreign institution
must provide information satisfactory to the NIAID, NIH that safety,
security, and training standards equivalent to those described in 42 CFR
part 73, 7 CFR part 331, and/or 9 CFR part 121 at:
(http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf)
are in place and will be administered on behalf of all Select Agent work
sponsored by these funds. The process for making this determination
includes inspection of the foreign laboratory facility by an NIAID
representative. During this inspection, the foreign institution must
provide the following information: concise summaries of safety, security,
and training plans; names of individuals at the foreign institution who
will have access to the Select Agents and procedures for ensuring that
only approved and appropriate individuals, in accordance with institution
procedures, will have access to the Select Agents under the contract; and
copies of or links to any applicable laws, regulations, policies, and
procedures applicable to that institution for the safe and secure
possession, use, and/or transfer of select agents. An NIAID-chaired
committee of U.S. federal employees (including representatives of NIH
grants/contracts and scientific program management, CDC, Department of
Justice and other federal intelligence agencies, and Department of State)
will ultimately assess the results of the laboratory facility inspection,
and the regulations, policies, and procedures of the foreign institution
for equivalence to the U.S. requirements described in 42 CFR part 73, 7
CFR part 331, and/or 9 CFR part 121
(http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf).
The committee will provide recommendations to the DEA Director, NIAID. The
DEA Director will make the approval decision and notify the Contracting
Officer. The Contracting Officer will inform the prime contractor of the
approval status of the foreign institution. No NIH funds can be used for
research involving Select Agents at a foreign institution until NIAID
grants this approval.
Listings of HHS select agents and toxins, and overlap select agents or toxins as
well as information about the registration process for domestic institutions,
are available on the Select Agent Program Web site at http://www.cdc.gov/od/sap/
and http://www.cdc.gov/od/sap/docs/salist.pdf. Listings of USDA select agents
and toxins as well as information about the registration process for domestic
institutions are available on the APHIS/USDA website at:
http://www.aphis.usda.gov/programs/ag_selectagent/index.html; and
http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html.
For foreign institutions, see the NIAID Select Agent Award information:
http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm
ARTICLE H.17. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)
Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund
in whole or in part a meeting, convention, conference or training seminar that
is conducted in, or that otherwise uses the rooms, facilities, or services of a
place of public accommodation that do not meet the requirements of the fire
prevention and control guidelines as described in the Public Law. This
restriction applies to public accommodations both foreign and domestic.
Public accommodations that meet the requirements can be accessed at:
http://www.usfa.fema.gov/hotel/index.htm
ARTICLE H.18. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
The contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the
provision of resources and support to, individuals and organizations associated
with terrorism. It is the legal responsibility of the contractor to ensure
compliance with these Executive
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Contract No. HHSN266200600014C
Orders and Laws. This clause must be included in all subcontracts issued under
this contract.
ARTICLE H.19. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS
RESULTING FROM NIH-FUNDED RESEARCH
The Policy requests that beginning May 2, 2005, NIH-funded investigators submit
to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an
electronic version of the author's final manuscript, upon acceptance for
publication, resulting from research supported in whole or in part with direct
costs from NIH. NIH defines the author's final manuscript as the final version
accepted for journal publication, and includes all modifications from the
publishing peer review process. The PMC archive will preserve permanently these
manuscripts for use by the public, health care providers, educators, scientists,
and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC:
http://www.pubmedcentral.nih.gov.
Additional information is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html.
ARTICLE H.20. SHARING RESEARCH DATA
The data sharing plan submitted by the contractor is acceptable. The contractor
agrees to adhere to its plan and shall request prior approval of the Contracting
Officer for any changes in its plan.
The NIH endorses the sharing of final research data to expedite the translation
of research results into knowledge, products, and procedures to improve human
health. this contract is expected to generate research data that must be shared
with the public and other researchers. NIH's data sharing policy may be found at
the following Web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
NIH recognizes that data sharing may be complicated or limited, in some cases,
by institutional policies, local IRB rules, as well as local, state and Federal
laws and regulations, including the Privacy Rule (see HHS-published
documentation on the Privacy Rule at http://www.hhs.gov/ocr/). The rights and
privacy of people who participate in NIH-funded research must be protected at
all times; thus, data intended for broader use should be free of identifiers
that would permit linkages to individual research participants and variables
that could lead to deductive disclosure of the identity of individual subjects.
ARTICLE H.21. INTELLECTUAL PROPERTY OPTION TO COLLABORATOR
NIAID may collaborate with an outside investigator who has proprietary rights to
compounds which may be assigned under this contract. This collaborator will be
identified by the Project Officer (PO) at the time of assignment and in this
case, the following option regarding Intellectual Property Rights will be
applicable.
Contractor agrees to promptly notify the NIAID and "Collaborator" in writing of
any inventions, discoveries or innovations made by the contractor's principal
investigator or any other employees or agents of the contractor, whether
patentable or not, which are conceived and/or first actually reduced to practice
in the performance of this study using Collaborator's Study Agent (hereinafter
"Contractor Inventions").
Contractor agrees to grant to Collaborator: (1) a paid-up nonexclusive,
nontransferable, royalty-free, world-wide license to all Contractor Inventions
for research purposes only; and (2) a time-limited first option to negotiate an
exclusive world-wide royalty-bearing license for all commercial purposes,
including the right to grant sub-licenses, to all Contractor Inventions on terms
to be negotiated in good faith by Collaborator and Contractor. Collaborator
shall notify Contractor, in writing, of its interest in obtaining an exclusive
license to any Contractor Invention within six (6) months of Collaborator's
receipt of notice of such Contractor Invention(s). In the event that
Collaborator fails to so notify Contractor or elects not to obtain an exclusive
license, then Collaborator's option shall expire with respect to that Contractor
Invention, and Contractor will be free to dispose of its interests in such
Contractor Invention in accordance with its own policies. If Contractor and
Collaborator fail to reach agreement within ninety (90) days, (or such
additional period as Collaborator and Contractor may agree) on the terms for an
exclusive license for a particular Contractor Invention, then for a period of
six (6) months thereafter, Contractor shall not offer to license the Contractor
Invention to any third party on materially better terms than those last offered
to Collaborator without first
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Contract No. HHSN266200600014C
offering such terms to Collaborator, in which case Collaborator shall have a
period of thirty (30) days in which to accept or reject the offer.
Contractor agrees that notwithstanding anything herein to the contrary, any
inventions, discoveries or innovations, whether patentable or not, which are not
Subject Inventions as defined in 35 U.S.C. 201(e),* arising out of any
unauthorized use of the Collaborator's Study Agent shall be the property of the
Collaborator (hereinafter "Collaborator Inventions"). Contractor will promptly
notify the Collaborator in writing of any such Collaborator Inventions and, at
Collaborator's request and expense, Contractor will cause to be assigned to
Collaborator all right, title and interest in an to any such Collaborator
Inventions and provide Collaborator with reasonable assistance to obtain patents
(including causing the execution of any invention assignment or other
documents). Contractor may also be conducting other more basic research using
Study Agent under the authority of a separate Material Transfer Agreement (MTA),
or other such agreement with the Collaborator. Inventions arising thereunder
shall be subject to the terms of the MTA, and not to this clause.
*35 U.S.C. (e): The term "subject invention" means any invention of the
contractor conceived or first actually reduced to practice in the performance of
work under a funding agreement: Provided, that in the case of a variety of
plant, the date of determination (as defined in section 41(d)(FOOTNOTE 1) of the
Plant Variety Protection Act (7 U.S.C. 2401(d))) must also occur during the
period of contract performance.
Protection of Proprietary Data
Data generated using an investigational agent proprietary to a Collaborator will
be kept confidential and shared only with the NIAID and the Collaborator. The
Contractor retains the right to publish research results subject to the terms of
this contract.
ARTICLE H.22. HUMAN MATERIALS
The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable State and Local laws and the provisions of the
Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.
ARTICLE H.23. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable State and Local laws and the provisions of the
Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.
The Contractor shall provide written documentation that all human materials
obtained as a result of research involving human subjects conducted under this
contract, by collaborating sites, or by subcontractors identified under this
contract, were obtained with prior approval by the Office for Human Research
Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46
to protect human research subjects. This restriction applies to all
collaborating sites without OHRP-approved Assurances, whether domestic or
foreign, and compliance must be ensured by the Contractor.
Provision by the Contractor to the Contracting Officer of a properly completed
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly
Optional Form 310), certifying IRB review and approval of the protocol from
which the human materials were obtained constitutes the written documentation
required. The human subject certification can be met by submission of a self
designated form, provided that it contains the information required by the
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly
Optional Form 310)
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Contract No. HHSN266200600014C
PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. DATE TITLE
- ----------- ---- -----
52.202-1 Jul 2004 Definitions (Over $100,000)
52.203-3 Apr 1984 Gratuities (Over $100,000)
52.203-5 Apr 1984 Covenant Against Contingent Fees (Over $100,000)
52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government
(Over $100,000)
52.203-7 Jul 1995 Anti-Kickback Procedures (Over $100,000)
52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000)
52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000)
52.203-12 Sep 2005 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000)
52.204-4 Aug 2000 Printed or Copied Double-Sided on Recycled Paper
(Over $100,000)
52.204-7 Jul 2006 Central Contractor Registration
52.209-6 Jan 2005 Protecting the Government's Interests When
Subcontracting With Contractors Debarred, Suspended, or
Proposed for Debarment (Over $25,000)
52.215-2 Jun 1999 Audit and Records - Negotiation (Over $100,000)
52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format
52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data
52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $500,000)
52.215-14 Oct 1997 Integrity of Unit Prices (Over $100,000)
52.215-15 Oct 2004 Pension Adjustments and Asset Reversions
52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement
Benefits (PRB) other than Pensions
52.215-19 Oct 1997 Notification of Ownership Changes
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Contract No. HHSN266200600014C
52.215-21 Oct 1997 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data - Modifications
52.216-7 Dec 2002 Allowable Cost and Payment
52.216-8 Mar 1997 Fixed Fee
52.219-8 May 2004 Utilization of Small Business Concerns (Over $100,000)
52.219-9 Jul 2005 Small Business Subcontracting Plan (Over $500,000,
$1,000,000 for Construction)
52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan
(Over $500,000, $1,000,000 for Construction)
52.222-2 Jul 1990 Payment for Overtime Premium (Over $100,000) (Note: The
dollar amount in paragraph (a) of this clause is $0
unless otherwise specified in the contract.)
52.222-3 Jun 2003 Convict Labor
52.222-21 Feb 1999 Prohibition of Segregated Facilities
52.222-26 Apr 2002 Equal Opportunity
52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible
Veterans
52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
52.222-37 Dec 2001 Employment Reports on Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible
Veterans
52.222-50 Apr 2006 Combating Trafficking in Persons
52.223-6 May 2001 Drug-Free Workplace
52.223-14 Aug 2003 Toxic Chemical Release Reporting (Over $100,000)
52.225-1 Jun 2003 Buy American Act - Supplies
52.225-13 Feb 2006 Restrictions on Certain Foreign Purchases
52.227-1 Jul 1995 Authorization and Consent, Alternate I (Apr 1984)
52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000)
52.227-11 Jun 1997 Patent Rights - Retention by the Contractor
(Short Form) (Note: In accordance with FAR 27.303(a)
(2), paragraph (f) is modified to include the
requirements in FAR 27.303(a)(2)(i) through (iv). The
frequency of reporting in (i) is annual.
52.227-14 Jun 1987 Rights in Data - General
52.232-9 Apr 1984 Limitation on Withholding of Payments
52.232-17 Jun 1996 Interest (Over $100,000)
52.232-20 Apr 1984 Limitation of Cost
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Contract No. HHSN266200600014C
52.232-23 Jan 1986 Assignment of Claims
52.232-25 Oct 2003 Prompt Payment, Alternate I (Feb 2002)
52.232-33 Oct 2003 Payment by Electronic Funds Transfer--Central
Contractor Registration
52.233-1 Jul 2002 Disputes
52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985)
52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim
52.242-1 Apr 1984 Notice of Intent to Disallow Costs
52.242-3 May 2001 Penalties for Unallowable Costs (Over $500,000)
52.242-4 Jan 1997 Certification of Final Indirect Costs
52.242-13 Jul 1995 Bankruptcy (Over $100,000)
52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2 Aug 1998 Subcontracts, Alternate I (January 2006)
52.244-5 Dec 1996 Competition in Subcontracting (Over $100,000)
52.244-6 Feb 2006 Subcontracts for Commercial Items
52.245-5 May 2004 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract)
52.245-9 Aug 2005 Use and Charges
52.246-23 Feb 1997 Limitation of Liability (Over $100,000)
52.249-6 Sep 1996 Termination (Cost-Reimbursement)
52.249-14 Apr 1984 Excusable Delays
52.253-1 Jan 1991 Computer Generated Forms
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. DATE TITLE
- ----------- ---- -----
352.202-1 Jan 2001 Definitions - with Alternate paragraph (h) (Jan 2001)
352.216-72 Oct 1990 Additional Cost Principles
352.228-7 Dec 1991 Insurance - Liability to Third Persons
352.232-9 Apr 1984 Withholding of Contract Payments
352.233-70 Apr 1984 Litigation and Claims
352.242-71 Apr 1984 Final Decisions on Audit Findings
352.270-5 Apr 1984 Key Personnel
352.270-6 Jul 1991 Publications and Publicity
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Contract No. HHSN266200600014C
352.270-7 Jan 2001 Paperwork Reduction Act
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - Rev. 07/2006].
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
Alternate IV (October 1997) of FAR Clause 52.215-21, Requirements For Cost
Or Pricing Data Or Information Other Than Cost Or Pricing
Data--Modifications (October 1997) is added.
FAR Clause 52.232-20, Limitation Of Cost (April 1984), is deleted in its
entirety and FAR Clause 52.232-22, Limitation Of Funds (April 1984) is
substituted therefor. [NOTE: When this contract is fully funded, FAR
Clause 52.232-22, LIMITATION OF FUNDS will no longer apply and FAR Clause
52.232-20, LIMITATION OF COST will become applicable.]
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
contracting officer will make their full text available.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
(1) FAR Clause 52.219-4, Notice of Price Evaluation Preference for
HUBZone Small Business Concerns (July 2005).
"(c) Waiver of evaluation preference.....
[ ] Offeror elects to waive the evaluation preference."
(2) FAR Clause 52.224-1, Privacy Act Notification (April 1984).
(3) FAR Clause 52.224-2, Privacy Act (April 1984).
(4) FAR Clause 52.227-14, Rights in Data - General (June 1987).
(5) Alternate I (June 1987), FAR Clause 52.227-14, Rights in
Data--General (June 1987).
(6) Alternate II (June 1987), FAR Clause 52.227-14, Rights in
Data--General (June 1987).
Additional purposes for which the limited rights data may be used
are:
(7) Alternate III (June 1987), FAR Clause 52.227-14, Rights in
Data--General (June 1987).
Additions to, or limitations on, the restricted rights set forth in
the Restricted Rights Notice of subparagraph (g)(3) of the clause
are expressly stated as follows:
(8) FAR Clause 52.227-16, Additional Data Requirements (June 1987).
(9) FAR Clause 52.227-23, Rights to Proposal Data (Technical) (June
1987).
(10) FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001).
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Contract No. HHSN266200600014C
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CHAPTER 3) CLAUSES:
(1) HHSAR Clause 352.223-70, Safety and Health (January 2001). This
clause is provided in full text in Section J - Attachments.
(2) HHSAR Clause 352.224-70, Confidentiality of Information (April 1984
- including revisions mandated by the 1/3/2005 Federal Register
notice which was effective March 2005).
(3) HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and
Seminars to Persons with Disabilities (January 2001).
(4) HHSAR Clause 352.270-8, Protection of Human Subjects (March 2005).
(5) HHSAR Clause 352.270-9, Care of Live Vertebrate Animals (March
2005).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
(1) NIH (RC)-7, Procurement of Certain Equipment (April 1984) (OMB
Bulletin 81-16).
(2) NIH(RC)-11, Research Patient Care Costs (4/1/84).
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:
a. FAR Clause 52.222-39, Notification Of Employee Rights Concerning Payment
Of Union Dues Or Fees (December 2004)
(a) Definition. As used in this clause--
United States means the 50 States, the District of Columbia, Puerto
Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S.
Virgin Islands, and Wake Island.
(b) Except as provided in paragraph (e) of this clause, during the term
of this contract, the Contractor shall post a notice, in the form of
a poster, informing employees of their rights concerning union
membership and payment of union dues and fees, in conspicuous places
in and about all its plants and offices, including all places where
notices to employees are customarily posted. The notice shall
include the following information (except that the information
pertaining to National Labor Relations Board shall not be included
in notices posted in the plants or offices of carriers subject to
the Railway Labor Act, as amended (45 U.S.C. 151-188)).
Notice to Employees
Under Federal law, employees cannot be required to join
a union or maintain membership in a union in order to
retain their jobs. Under certain conditions, the law
permits a union and an employer to enter into a
union-security agreement requiring employees to pay
uniform periodic dues and initiation fees. However,
employees who are not union members can object to the
use of their payments for certain purposes and can only
be required to pay their share of union costs relating
to collective bargaining, contract administration, and
grievance adjustment.
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Contract No. HHSN266200600014C
If you do not want to pay that portion of dues or fees
used to support activities not related to collective
bargaining, contract administration, or grievance
adjustment, you are entitled to an appropriate reduction
in your payment. If you believe that you have been
required to pay dues or fees used in part to support
activities not related to collective bargaining,
contract administration, or grievance adjustment, you
may be entitled to a refund and to an appropriate
reduction in future payments.
For further information concerning your rights, you may
wish to contact the National Labor Relations Board
(NLRB) either at one of its Regional offices or at the
following address or toll free number:
National Labor Relations Board
Division of Information
1099 14th Street, N.W.
Washington, DC 20570
1-866-667-6572
1-866-316-6572 (TTY)
To locate the nearest NLRB office, see NLRB's website at
http://www.nlrb.gov.
(c) The Contractor shall comply with all provisions of Executive Order 13201
of February 17, 2001, and related implementing regulations at 29 CFR part
470, and orders of the Secretary of Labor.
(d) In the event that the Contractor does not comply with any of the
requirements set forth in paragraphs (b), (c), or (g), the Secretary may
direct that this contract be cancelled, terminated, or suspended in whole
or in part, and declare the Contractor ineligible for further Government
contracts in accordance with procedures at 29 CFR part 470, Subpart
B--Compliance Evaluations, Complaint Investigations and Enforcement
Procedures. Such other sanctions or remedies may be imposed as are
provided by 29 CFR part 470, which implements Executive Order 13201, or as
are otherwise provided by law.
(e) The requirement to post the employee notice in paragraph (b) does not
apply to--
(1) Contractors and subcontractors that employ fewer than 15 persons;
(2) Contractor establishments or construction work sites where no union
has been formally recognized by the Contractor or certified as the
exclusive bargaining representative of the Contractor's employees;
(3) Contractor establishments or construction work sites located in a
jurisdiction named in the definition of the United States in which
the law of that jurisdiction forbids enforcement of union-security
agreements;
(4) Contractor facilities where upon the written request of the
Contractor, the Department of Labor Deputy Assistant Secretary for
Labor-Management Programs has waived the posting requirements with
respect to any of the Contractor's facilities if the Deputy
Assistant Secretary finds that the Contractor has demonstrated
that--
(i) The facility is in all respects separate and distinct from
activities of the Contractor related to the performance of a
contract; and
(ii) Such a waiver will not interfere with or impede the
effectuation of the Executive order; or
(5) Work outside the United States that does not involve the recruitment
or employment of workers within the United States.
(f) The Department of Labor publishes the official employee notice in two
variations; one for contractors covered by the Railway Labor Act and a
second for all other contractors. The Contractor shall--
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Contract No. HHSN266200600014C
(1) Obtain the required employee notice poster from the Division of
Interpretations and Standards, Office of Labor-Management Standards,
U.S. Department of Labor, 200 Constitution Avenue, NW, Room N-5605,
Washington, DC 20210, or from any field office of the Department's
Office of Labor-Management Standards or Office of Federal Contract
Compliance Programs;
(2) Download a copy of the poster from the Office of Labor-Management
Standards website at http://www.olms.dol.gov; or
(3) Reproduce and use exact duplicate copies of the Department of
Labor's official poster.
(g) The Contractor shall include the substance of this clause in every
subcontract or purchase order that exceeds the simplified acquisition
threshold, entered into in connection with this contract, unless exempted
by the Department of Labor Deputy Assistant Secretary for Labor-Management
Programs on account of special circumstances in the national interest
under authority of 29 CFR 470.3(c). For indefinite quantity subcontracts,
the Contractor shall include the substance of this clause if the value of
orders in any calendar year of the subcontract is expected to exceed the
simplified acquisition threshold. Pursuant to 29 CFR part 470, Subpart
B--Compliance Evaluations, Complaint Investigations and Enforcement
Procedures, the Secretary of Labor may direct the Contractor to take such
action in the enforcement of these regulations, including the imposition
of sanctions for noncompliance with respect to any such subcontract or
purchase order. If the Contractor becomes involved in litigation with a
subcontractor or vendor, or is threatened with such involvement, as a
result of such direction, the Contractor may request the United States,
through the Secretary of Labor, to enter into such litigation to protect
the interests of the United States.
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Exhibit 31
CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Thomas N. Konatich, certify that:
1. I have reviewed this quarterly report on Form 10-Q/A of SIGA
Technologies, Inc.;
2. Based on my knowledge, this report does not contain any untrue
statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect
to the period covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all
material respects the financial condition, results of operations and
cash flows of the registrant as of, and for, the periods presented
in this report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the
registrant and have:
(a) Designed such disclosure controls and procedures, or caused
such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly
during the period in which this quarterly report is being
prepared;
(b) Evaluated the effectiveness of the registrant's disclosure
controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this
report based on such evaluation; and
(c) Disclosed in this report any change in the registrant's
internal control over financial reporting that occurred during
the registrant's most recent fiscal quarter that has
materially affected, or is reasonably likely to materially
affect, the registrant's internal control over financial
reporting; and
5. The registrant's other certifying officer and I have disclosed,
based on our most recent evaluation of internal control over
financial reporting, to the registrant's auditors and the audit
committee of registrant's board of directors (or persons performing
the equivalent functions);
(a) All significant deficiencies and material weaknesses in the
design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the
registrant's ability to record, process, summarize and report
financial information; and
(b) Any fraud, whether or not material, that involves management
or other employees who have a significant role in the
registrant's internal control over financial reporting.
Date: November 13, 2006 By: /s/ Thomas N. Konatich
----------------------
Thomas N. Konatich
Chief Financial Officer and
Acting Chief Executive Officer
Exhibit 32
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Amendment No. 1 to Quarterly Report of SIGA
Technologies, Inc. (the "Company") on Form 10-Q/A for the period ending
September 30, 2006 as filed with the Securities and Exchange Commission on the
date hereof (the "Report"), I, Thomas N. Konatich., Chief Financial Officer and
Acting Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C.
ss.1350, as adopted pursuant to ss.906 of the Sarbanes-Oxley Act of 2002, that,
to the best of my knowledge:
(1) The Report fully complies with the requirements of section
13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in
all material respects, the financial condition and results of
operations of the Company.
November 13, 2006
/s/ Thomas N. Konatich
----------------------
Thomas N. Konatich
Chief Financial Officer and
Acting Chief Executive Officer