Delaware
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0-23047
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13-3864870
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(State or other jurisdiction of
incorporation or organization)
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(Commission file number)
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(I.R.S. employer
identification no.)
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35 East 62nd Street
New York, New York
(Address of principal executive
offices) |
10065
(Zip code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Exhibit No . | Description | ||
10.1 | Contract dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment). | ||
99.1 | Press Release, dated May 13, 2011 | ||
99.2 | Press Release, dated May 15, 2011 |
SIGA TECHNOLOGIES, INC. | |||
By: | /s/ Daniel J. Luckshire | ||
Name: | Daniel J. Luckshire | ||
Title: | Chief Financial Officer |
1. |
THIS CONTRACT IS A RATED ORDER
|
RATING | PAGE | OF | PAGES | |
AWARD/CONTRACT | UNDER DPAS (15 CFR 350) 4 | N/A | 1 | 128 |
2. | CONTRACT (Proc. Inst. Ident.) NO. | 3. | EFFECTIVE DATE | 4. REQUISITION/PURCHASE REQUEST/PROJECT NO. |
HHSO100201100001C | See Block 20 C. | OS51169 |
5. | ISSUED BY | CODE | 6. | ADMINISTERED BY (If other than Item 6) | CODE | ||
Office of Acquisitions, Management, Contracts, & Grants | Office of Acquisitions, Management, Contracts, & Grants | ||||||
(AMCG) | (AMCG) | ||||||
330 Independence Ave., S.W. Room G640 | 330 Independence Ave., S.W. Room G640 | ||||||
Washington, D.C. 20201
|
Washington, D.C. 20201 |
7. | NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code) | 8. | DELIVERY | ||
c FOB ORIGIN | x OTHER (See below) | ||||
SIGA TECHNOLOGIES, INC. | See Article F.2.a. | ||||
35 E 62 nd Street | 9. | DISCOUNT FOR PROMPT PAYMENT | |||
New York, NY 10065 |
N/A
|
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10. | SUBMIT INVOICES | ITEM | |||
CODE DUNS No. 08-513-4083 | FACILITY CODE | ADDRESS SHOWN IN: | Art. G.4. |
16. TABLE OF CONTENTS | |||||||
( ü ) | SEC. | DESCRIPTION | PAGE(S) | ( ü ) | SEC. | DESCRIPTION | PAGE(S) |
PART I - THE SCHEDULE | PART II - CONTRACT CLAUSES | ||||||
x | A | SOLICITATION/CONTRACT FORM | 1 | x | I | CONTRACT CLAUSES | 77 |
x | B | SUPPLIES OR SERVICES AND PRICE/COST | 3 | PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. | |||
x | C | DESCRIPTION/SPECS./WORK STATEMENT | 24 | x | J | LIST OF ATTACHMENTS | 85 |
x | D | PACKAGING AND MARKING | 36 | PART IV - REPRESENTATIONS AND INSTRUCTIONS | |||
x | E | INSPECTION AND ACCEPTANCE | 37 | c | K | REPRESENTATIONS, CERTIFICATIONS | |
x | F | DELIVERIES OR PERFORMANCE | 38 | AND OTHER STATEMENTS OF CONTRACTORS | |||
x | G | CONTRACT ADMINISTRATION DATA | 60 | c | L | INSTRS., CONDS., AND NOTICES TO | |
x | H | SPECIAL CONTRACT REQUIREMENTS | 65 | c | M | EVALUATION FACTORS FOR AWARD | |
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE |
17. x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return _2 copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.) | 18. c AWARD (Contractor is not required to sign this document.) Your offer on Solicitation Number ___ _______________________________, including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary. | ||||||||
19A. NAME AND TITLE OF SIGNER (Type or print) | 20A. | NAME OF CONTRACTING OFFICER | |||||||
Eric Rose, Chairman and CEO |
Brian K. Goodger, AMCG/ASPR/HHS
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19B. NAME OF CONTRACTOR | 19C. DATE SIGNED | 20B. | UNITED STATES OF AMERICA | 20C. DATE SIGNED | |||||
/s/ Eric Rose
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5/10/2011 | BY | /s/ Brian K. Goodger | 5/13/2011 | |||||
(Signature of person authorized to sign) | (Signature of Contracting Officer) |
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) |
Page # | |
Part I – The Schedule | |
Section A – Solicitation Form | 1 |
Section B – Supplies or Services and Price/Costs | 3 |
Section C – Statement of Objectives | 22 |
Section D – Packaging and Marking | 28 |
Section E – Inspection and Acceptance | 29 |
Section F – Deliveries or Performance | 30 |
Section G – Contract Administration | 36 |
Section H – Special Contract Requirements | 40 |
Part II – Contract Clauses | |
Section I – Contract Clauses | 52 |
Part III – Attachments | |
Section J – List of Documents, Exhibits, and Other Attachments | 60 |
B. 1. Background | |||
B. 1.1 | The Department of Health and Human Services (HHS) has the lead responsibility within the federal government to protect the health of the civilian population against chemical, biological, radiological, and nuclear (CBRN) threats by providing leadership in research, development, acquisition, and deployment of effective medical countermeasures. The Biomedical Advanced Research and Development Authority (BARDA) promotes the advanced research, development and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative approaches to meet the threat of CBRN agents in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the PHEMCE implementation plan (available at: https://www.medicalcountermeasures.gov/Reports.aspx ). | ||
B. 1.2 | As such BARDA, which falls under the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS), for the advanced development and acquisition of smallpox antiviral drugs for the Strategic National Stockpile to support a smallpox public health medical emergency. The increased threat of terrorism underscores the compelling need to develop improved medical countermeasures for protecting all segments of the civilian population. | ||
B. 1.3 | A large portion of the U.S. population is susceptible to variola virus infection (smallpox). Smallpox vaccination of the general U.S. civilian population stopped in 1972. Since routine smallpox vaccination ended 39 years ago, less than half of U.S. citizens have been vaccinated against smallpox. For those who have been vaccinated, the exact duration of protective immunity is unknown. | ||
B. 1.4 | In the event of a smallpox outbreak, vaccination is the first line of defense as it has been field-tested and is known to be effective. HHS has procured sufficient live smallpox vaccine to protect every person in the United States. HHS has also procured Vaccinia Immune Globulin (VIG) to treat some of the complications that may arise from smallpox vaccination. In addition to the current live smallpox vaccine, HHS is acquiring sufficient doses of Modified Vaccinia Ankara (MVA) vaccine to protect 20 million immunocompromised persons for whom the current live vaccine may cause serious side effects. To supplement the existing smallpox preparedness portfolio, HHS is pursuing the acquisition of a smallpox antiviral drug for the treatment of individuals who are symptomatic. | ||
B. 1.5 | The PHEMCE Implementation Plan prioritized smallpox antivirals as a key acquisition in the 2009 to 2013 time frame. The antiviral would be recommended for treatment of individuals who become symptomatic prior to vaccination or where the vaccine is given too late to be effective. There is currently no approved treatment for smallpox disease. |
B. 2. Project Identification and Purpose | |||
B. 2.1 | The purpose of this award is to seek 1,700,000 treatment courses of smallpox antiviral Final Drug Product (FDP) that can be delivered to the Centers for Disease Control and Prevention Strategic National Stockpile (CDC/SNS). The antiviral drug must be an oral formulation in unit-of-use bottles or other packaging that provides the best value to the U.S. Government (USG), with a minimum expiry dating of 60 months from date of manufacture (with at least 56 months of shelf life remaining upon delivery) and must be manufactured in accordance with current Good Manufacturing Practices (cGMP). Acceptance of product into the SNS requires that the FDP meet, at a minimum, specifications determined by the U.S. Food & Drug Administration (FDA). The smallpox antiviral drug shall be developed for both potential pre-approval uses during a declared emergency under an Emergency Use Authorization (EUA) and for ultimate approval by the FDA. | ||
B. 2.2
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The Contractor should consult
http://www.fda.gov/oc/guidance/emergencyuse.html
for information concerning EUA. Fulfillment of the initial requirements, to include preliminary data providing evidence of safety and potential benefit of the candidate drug, and evidence of sustained progress toward successful filing and approval of a New Drug Application (NDA), may allow for the potential use of the smallpox antiviral drug under an EUA during a declared emergency.
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B.3. Specific Technical Requirements
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B. 3.1
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The Contractor shall provide the necessary qualified personnel, facilities, material, equipment (except Government property), and services to produce, test, formulate, fill, package, store and deliver the smallpox antiviral drug. The manufacture, formulation, filling, and testing of the smallpox antiviral drug shall be done in accordance with the Contractor’s Standard Operating Procedures, and all federal statutory and regulatory requirements.
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B.4. Price/Costs
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B. 4.1
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Reserved | ||
B. 4.2
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In consideration for completion of the work to be performed under Contract Line Item Numbers (CLINs) as shown below, and in accordance with the Statement of Objectives, the Contractor shall be paid as stated in this award.
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BASE | ||||||
CLIN# |
Cost
Type |
Supply or Service | U/I | Qty | Unit Price | Extended Price |
0001 | FFP | Manufacture and deliver 1,700,000 smallpox antiviral treatment courses (minimum 60 month stability from date of manufacture) to support appropriate regulatory filing submitted by CDC as described in Section C.1) | EA | 1,700,000 | [redacted] | $307,358,816.00 |
0001AA | Advance Payments | JOB | [redacted] | [redacted] | $40,981,175.00 | |
0001AB |
Milestone Payment 1:
Successful submission of NDA |
JOB | [redacted] | [redacted] | $20,490,587.00 | |
0001AC |
Milestone Payment 2:
Complete FDP Commercial Validation batches and report |
JOB | [redacted] | [redacted] | $8,196,235.00 | |
0001AD |
Milestone Payment 3:
Approved product labeling strategy |
JOB | [redacted] | [redacted] | $12,294,352.00 | |
0002 | FFP | Payment upon NDA Approval for treatment courses. CLIN contains the cumulative discount price ([redacted] holdback) from CLIN 0001 | EA | 1,700,000 | [redacted] | $102,452,939.00 |
0003 | FFP | Storage, shipping & delivery of 1,700,000 Smallpox antiviral treatment courses delivered under CLIN 001 as described in Section C.5 | JOB | [redacted] | ||
0004 | FFP | Re-labeling of IND to approved product delivered under CLIN 0001 as described in Section D.2 | EA | [redacted] | [redacted] | [redacted] |
0005 | FFP | Design and submission of Phase 4 Marketing Plan in Section C.4.5 | JOB | [redacted] | ||
0006 | FFP | Disposition of product as described in Section C.5.8 | JOB | [redacted] | [redacted] | |
0012 | Payment for FDA Approval for extension to 60-Month Expiry Product, as described in Section C.1 (NSP) | JOB | [redacted] | [redacted] | ||
0022 | Delivery of 300,000 Treatment Courses (NSP) as described in Section C.1.1.1 | Job | [redacted] | [redacted] | [redacted] | |
Total Firm Fixed Price | $412,467,847.00 | |||||
CLIN# |
Cost
Type |
Supply or Service | Estimated Cost | Fee | Total CPFF | |
0007 | CPFF | Supportive Studies (Clinical/Non- Clinical) to include, but not limited to stability, non-clinical, and clinical studies as described in Sections C.2, and C.4) | [redacted] | [redacted] | [redacted] | |
0008 | CPFF | Security of Contract Operations as described in Section J | [redacted] | [redacted] | [redacted] | |
0009 | CPFF | Information Technology Security, as described in Section J | [redacted] | [redacted] | [redacted] | |
0017 | CPFF | Concept Plan and development activities for a pediatric liquid formulation to extend label indication. Statement of Work acceptance is due within six (6) months of award as described in Section C.2.5 | JOB | [redacted] | [redacted] | [redacted] |
Total Cost CFFF | $20,417,978.00 | |||||
Total Cost Base Contract | $432,885,825.00 |
OPTION | ||||||
CLIN# |
Cost
Type |
Supply or Service | U/I | Qty | Unit Price | Extended Price |
0010 | FFP | Implementation of Post Marketing Plan under CLIN 0006, as described in C.7.7 | [redacted] | [redacted] | [redacted] | |
0011 | FFP | Payment for FDA Approval for extension to 84-Month Expiry Product, as described in Section C.7.1 (NSP) | [redacted] | 50,000,000 |
0013 | FFP | Re-labeling to 84-month Expiry Product as described in Section C.7.1 | EA | [redacted] | [redacted] | [redacted] |
0014 | FFP | Purchase of Additional Treatment Courses (Up to 12 Million). As described in Section C.7.5 | EA | TBD | $ 180.00 | TBD |
Total Option Firm Fixed Price | $57,046,885.00 | |||||
OPTION | ||||||
CLIN# |
Cost
Type |
Supply or Service | Estimated Cost | Fee | Total CPFF | |
0015 | CPFF | Additional Clinical and Non –Clinical Studies as described in Section C.7.8 | JOB | [redacted] | [redacted] | [redacted] |
0016 | CPFF | Concept Plan and Implementation of IV Formulation, as described Section C.7.3 | JOB | [redacted] | [redacted] | [redacted] |
0018 | CPFF | Concept Plan and Implementation for studies to extend label indication for liquid formulation in Geriatric population as described in Section C.5.7 and C.7.2 | JOB | [redacted] | [redacted] | [redacted] |
0019 | CFFF | Concept Plan and Implementation of Post Event Prophylaxis Indication, as described in Section C.7.4 | JOB | [redacted] | [redacted] | [redacted] |
0020 | CPFF | Implementation of cGMP Warm-Base Manufacturing, as described in Section C.7.6 | [redacted] | [redacted] | [redacted] | |
0021 | CPFF | Implementation of drug substance, drug product, non-clinical, clinical and regulatory activities to support extending label indication for liquid formulation for a pediatric population , as described in Section C.7.2 | JOB | [redacted] | [redacted] | [redacted] |
Total CPFF | $121,328,946.00 | |||||
Total OPTION Price (FFP+CPFF) | $178,375,831.00 |
B.6.1.1 | Inspections & Collection of Samples | ||||
B.6.1.1.1 | At the discretion of the US Government (USG) an independent of testing conducted by the Contractor, the USG reserves the right to conduct site visits and collect samples of product held by the Contractor and in the SNS. | ||||
B.6.1.1.2 | The USG reserves the right to conduct inspections of all aspects of the contracted project including, but not limited to, the manufacturing plant and production records, testing and development laboratories, regulatory files and QMS records. | ||||
B.6.1.2 | FDA Approval Hold Back | ||||
B.6.1.2.1 | The negotiated dollar amount equivalent to [redacted] will be withheld from payment under CLIN 0001 until such time as the Contractor achieves CDER approval. This pertains to FDP doses that are delivered to the SNS prior to approval. After achieving CDER approval, the Contractor shall invoice for monies to be paid under CLIN 0002 or an amount equal to [redacted] per treatment course already delivered to the SNS. | ||||
B.6.1.3 | Person-in-Plant | ||||
B.6.1.2.1 | With 7 days advance notice to the Contractor, the government may place a person-in-plant in the Contractor’s facility. The person-in-plant is for the purposes of observing, verifying, and surveying the Contractor’s performance under this Contract, or other duties as delegated by the Contracting Officer. | ||||
B.6.1.4 | Access to Documentation/Data | ||||
B.6.1.4.1 | BARDA shall have physical and electronic access to all documentation and data generated under this Contract, including: all data documenting Contractor performance ; all data generated regarding clinical and non-clinical studies; all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. Contractor shall provide BARDA with an electronic copy of all correspondence with the FDA within 24 hours of receipt. The government shall acquire unlimited rights to all animal and human data funded under this Contract in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14 (See Section I.1) . |
B.6.1.5 | Specific Cost Element | |||||||
B.6.1.5.1 | Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, incorporated in the Contract, unless authorized in writing by the Contracting Officer via a Contracting Officer Authorization (COA) Letter, 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.6.1.5.1.below; | |||||||
6. | Any cost reimbursement subcontracts for Consultant services and any firm fixed price (FFP) subcontract for Consultant services that exceed $100,000; | |||||||
7. | Any cost reimbursement subcontracts and FFP subcontracts that exceed $100,000 ; | |||||||
8. | Research patient care costs – See Attachment 1; | |||||||
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, see Article G.10), regardless of acquisition value. | |||||||
10. | Printing Costs (as defined in the Government Printing and Binding Regulations). | |||||||
11. | Light Refreshment and Meal Expenditures. Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer, with a copy to the Project Officer, at least six (6) weeks in advance of the event. | |||||||
B.6.1.5.1 | Travel Costs | |||||||
I. Domestic Travel | ||||||||
a. | Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this Contract shall not exceed $3,000 per person without the prior written approval of the Contracting Officer via a Contracting Officer Authorization (COA) Letter. | |||||||
b. | Subject to the annual dollar limitation specified under B.6.1.5.1 above the Contractor shall invoice and be reimbursed for all travel costs in accordance with FAR Subpart 31.2 contracts with Commercial Organizations and FAR § 31.205-46 Travel Costs |
II. Foreign Travel
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a. | Total expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed $5,000 per person without prior written approval of the Contracting Officer. 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 AMCG 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. | |||||||
B.6.1.5.2 |
Award of any FFP subcontract or FFP consulting agreement in excess of $100,000 or any cost reimbursement, labor hour subcontract or consulting agreement funded under a Cost Plus Fixed Fee CLIN shall not proceed without the prior written consent of the Contracting Officer via a Contracting Officer Authorization (COA) Letter upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer.
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B.6.1.5.3 | Clinical and Non-Clinical Studies require Contracting Officer Authorization (COA) Letter: | |||||||
Draft protocols for each clinical and non-clinical study will be submitted to the BARDA Contracting Officer’s Technical Representative (COTR) and CO for COA Letter to the Contractor to authorize the study(ies). (as set forth in Section H)
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B.6.1.6 | Definitions | ||||
B.6.1.6.1 | Emergency Use Authorization (EUA) – see http://www.fda.gov/oc/guidance/emergencyuse.html | ||||
B.6.1.6.2 | All references to Product mean “a product or product surrogate that is deemed acceptable by the FDA.” | ||||
B.6.1.6.3 | Subcontractor means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime Contractor or another subcontractor. | ||||
B. 6.2 Approved Subcontractors and Consultants | |||
(a) | Subcontractor | ||
1. | [redacted] | ||
2. | [redacted] | ||
3. | [redacted] | ||
4. | [redacted] |
B.7 Basis of Contract Pricing Terms | |||||
Reserved | |||||
. | |||||
B.8. Payment Conditioned on Delivery | |||||
B. 8.1 | Delivery of not less than 500,000 treatment courses under CLIN 0001 is a condition for any payment under this contract. The Contractor may not invoice for a CLIN prior to the initial delivery of 500,000 treatment courses. Advance Payment and or Milestone Payments have been addressed during negotiations (See H.16.). | ||||
B.8.2 | Payments at a discounted price (CLIN 0001) will be made to the Contractor for product prior to FDA approval and for FDA approved product. Upon delivery of FDA approved product, supplemental payment (CLIN 0002) will then be made to the Contractor as set forth in the schedule. | ||||
B. 8.3 | Product accepted into the SNS that falls into any of the following three categories shall be replaced by the Contractor at no cost to BARDA: | ||||
B.8.3.1 | In the event that final FDA approved product is different from any product previously delivered to the SNS, the Contractor must replace the previously delivered product with FDA approved product at no cost to the government. In addition the Contractor will not receive any supplemental payments under CLIN 0002 until all previously delivered product has been replaced with FDA approved product. | ||||
B.8.3.2 | Product that does not meet any specified label claims, fails release testing or does not meet 38 month expiry period shall be replaced at no-cost to the government. See B.6.1.7. Product Replacement. | ||||
B.8.3.3 | Product deemed to be recalled for any reason, as outlined in Product Recalls, Including Removals and Corrections published by U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs; or based upon Chapter 7 of the Regulatory Procedures Manual of March 2007. |
PHS Policy on Humane Care and Use of Laboratory Animals | |||||||
B.9.1.1.1 | Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current Institutional Animal Care and Use Committees (IACUC) documentation of continuing review and approval and the Office of Laboratory Animal Welfare (OLAW- National Institutes of Health) Federal Wide Assurance (FWA) number for the institution or site. | ||||||
B.9.1.1.2 | If other institutions are involved in the research (e.g., a multicenter trial or study), each institution's IACUC must review and approve the protocol. They must also provide BARDA initial documentation and documentation of continuing review and approval and FWA number. | ||||||
B.9.1.1.3 | The Contractor must ensure that the application as well as all protocols are reviewed by the performing institution’s IACUC. | ||||||
B.9.1.1.4 | To help ensure the safety of animals used in BARDA funded studies, the Contractor must provide BARDA copies of documents related to all major changes in the status of ongoing protocols, including the following: | ||||||
a) | All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid. | ||||||
b) | All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable) | ||||||
c) | Termination or temporary suspension of the study(ies) for regulatory issues | ||||||
d) | Termination or temporary suspension of the protocol. | ||||||
e) | Any change that is made in the specific IACUC approval for the indicated study(ies). | ||||||
f) | Any other problems or issues that could affect the scientific integrity of the study(ies), i.e. fraud, misrepresentation, misappropriation of funds, etc. |
B.9.1.1.5 | Contractors must notify BARDA by email or fax of any of the above changes within three business days from the time Contractor becomes aware of such changes, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IACUC and a copy of any responses from the IACUC. | ||
B.9.1.1.6 | If a non-clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules. |
B.9.1.2 Non-Clinical Data and Safety Monitoring Requirements | |||
B.9.1.2.1 | The Contractor shall continue safety monitoring for all non-clinical studies of investigational drugs, devices, or biologics. FDA expects non-clinical studies to include safety in addition to efficacy. Contractor should consider evaluation of clinical relevant safety markers in the pivotal and non-pivotal, non-clinical studies. | ||
B.9.1.2.2 | BARDA will work with the Contractors on decisions regarding the type and extent of safety data accrual to be employed before the start of efficacy or safety studies. | ||
B.9.1.2.3 | The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary. |
1. | IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria. | ||
2. | Documentation of IACUC approval, including OLAW FWA number, IACUC registration number, and IACUC name. |
3. | Contractor should reduce the number of animals required for a study using power of statistics | ||
4. | Plans for the management of side effects, rules for interventions and euthanasia criteria | ||
5. | Procedures for assessing and collecting safety data | ||
6. | If a study is contracted through CRO(s), work orders and service agreements the Contractor shall assure that an integrated safety documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and laboratory services (including histopathology). | ||
7. | Documentation that the Contractor or CRO and all staff responsible for the conduct of the research have received required training in the protection and handling of animals | ||
8. | Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer. The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third party, in the event that the protocols do not obtain approval | ||
9. | Provide justification for whether studies require good laboratory practice (GLP) conditions | ||
10. | Provide justification for whether studies will be classified as non-pivotal or pivotal studies |
B.9.1.3.2 | BARDA will make its best efforts to forward comments to the Contractor within two weeks (10 business days) of receipt of the above information. The Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by BARDA staff to the satisfaction of BARDA before study execution. After receiving the updated documentation, that satisfies BARDA a written COA Letter will be provided to the Contractor. This COA provides authorization to the Contractor to execute the specific nonclinical study funded in part or in whole by BARDA. | ||
B.9.1.3.3. | In case of problems or issues, the BARDA COTR will contact the Contractor within two weeks (10 business days) by email or fax, followed within 30 calendar days by an official letter to the principal investigator, with a copy to the institution’s office of sponsored programs, listing issues and appropriate actions to be discussed. | ||
B.9.1.3.4 | Final decisions regarding ongoing safety reporting requirements for research not performed under an Investigational New Drug Application (IND) or investigational device exemption (IDE) must be made jointly by the BARDA and the Contractor. |
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval | ||||
B.9.2.1.1 | Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site. | |||
B.9.2.1.2 | If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution's IRB or IEC must review and approve the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number. | |||
B.9.2.1.3 | The grantee institution must ensure that the application as well as all protocols are reviewed by their IRB or IEC. | |||
B.9.2.2.3 | The type of monitoring to be used shall be mutually agreed upon between the Contractor and BARDA before enrollment starts. Discussions with the responsible BARDA COTR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following: | |||
1. | Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues. | |||
2. | Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study. | |||
3. | Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. | |||
B.9.2.2.4 | When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by BARDA before enrollment starts. | |||
B.9.2.2.5 | Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the BARDA within 30 days of reviews or meetings. |
C. 1. | General Objectives | |||
[redacted] | ||||
C.1.1. | [redacted] | |||
C.1.1.1 | [redacted] | |||
C.1.2. | [redacted] | |||
C.1.3. | [redacted] | |||
C.1.4. | [redacted] | |||
C.1.5. | [redacted] |
I. | [redacted] | ||
II. | [redacted] | ||
III. | [redacted] | ||
IV. | [redacted] | ||
V. | [redacted] | ||
VI. | [redacted] | ||
VII. | [redacted] | ||
[redacted] |
C.6.4.
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[redacted] | ||||||
C.6.4.1 | [redacted] |
1. | [redacted] | ||
2. | [redacted] | ||
3.
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[redacted] | ||
4.
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[redacted] | ||
5.
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[redacted] | ||
6. | [redacted] | ||
7.
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[redacted] | ||
8.
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[redacted] |
C.6.5
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[redacted] |
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C.6.5.1
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[redacted]
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C.6.6. |
[redacted]
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C.6.6.1. |
[redacted]
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C.6.6.2 |
[redacted]
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C.6.6.3 |
[redacted]
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C.6.7. |
[redacted]
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C.6.8.
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[redacted] | ||||
C.6.9
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[redacted]
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C.7.1.
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The USG may exercise an optional CLIN to increase the expiry period of the product to 84 months (from date of manufacture).
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C.7.1.1
|
The Contractor shall develop a plan to conduct stability testing on BDS and FDP in conformance with FDA requirements to extend expiry dating to 84 months (from date of manufacture), and seek approval to extend the expiry dating period as appropriate. If the option is exercised, the Contractor shall implement the proposed plan to seek extended expiration dating. (CLIN 0011)
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C.7.1.2. |
The Contractor shall develop and implement a plan to address any FDA labeling requirements, such as re-labeling product, associated with obtaining 84 -month expiration dating. (CLIN 0013)
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C.7.2 | The USG may exercise an optional CLIN to extend the age range for which the antiviral drug is indicated and to include a liquid formulation for the treatment of geriatric and pediatric populations. | |||
C.7.2.1 | The Contractor shall develop a concept plan to conduct studies to extend the range of ages for which the approved antiviral drug is indicated. If the option is exercised, the Contractor shall implement the proposed plan to seek extension of the indicated age range. | |||
C.7.2.2 | The Contractor shall develop a concept plan to conduct studies to include a liquid formulation for therapeutic indication in the geriatric population. If the option is exercised, the Contractor shall implement the proposed plan to include a liquid formulation for a therapeutic indication in the geriatric population. (CLIN 0018) | |||
C.7.2.3 | The Contractor shall continue the development of a liquid formulation for a therapeutic indication in the pediatric population. If the option is exercised, the Contractor shall implement follow-on development activities initiated under CLIN 0017 which are necessary to support a liquid formulation. Contractor shall follow the Pediatric Liquid Formulation Plan (developed under CLIN 0017) to guide activities under CLIN 0021. | |||
C.7.3. | BARDA may exercise an optional CLIN to extend the label indication to include an intravenous (I.V.) formulation. (CLIN 0016) | |||
C.7.3.1 | The Contractor shall develop a concept plan to conduct post-approval studies to extend the label indication to include an I.V. formulation for the treatment of severely ill individuals. If the option is exercised, the Contractor shall implement the proposed plan to seek label extension to include an I.V. formulation. | |||
C.7.4. | BARDA may exercise an optional CLIN to extend the label indication to include post event prophylactic use. (CLIN 0019) | |||
C.7.4.1 | The Contractor shall develop a concept plan to conduct human and animal studies to extend the label indication to include prophylactic use of the antiviral in individuals contraindicated for vaccination, either in place of vaccination or in combination with vaccination to reduce the side effects of the live vaccine. If the option is exercised, the Contractor shall implement the proposed plan to seek label extension to include prophylactic use in vaccine-contraindicated populations. | |||
C.7.5 | BARDA may exercise optional CLINs to purchase additional antiviral treatment courses. (CLIN 0014) | |||
C.7.5.1 | The Contractor shall submit a plan and schedule for antiviral drug product manufacture and control at large-scale production and under cGMP compliance to deliver up to an additional 12 million treatment courses. |
See section F.3 for specific reporting requirements.
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C.9.1 | Performance of the contract will be monitored by the COTR and CO on a regular basis via teleconference every two weeks, monthly reports, and quarterly basis via site visits. The Contracting Officer will be responsible for inspection and acceptance of product; the COTR and CO will be responsible for conducting an annual performance evaluation, and facilitating the Project Coordination Team (PCT). | ||
C.9.2 | Monitoring of the development contract will be based on periodic reporting by the Contractor. Reporting requirements and deliverables will be supplemented by quarterly visits to relevant development, manufacturing or administrative sites. The first “kick-off” site visit will be convened within 30 days of contract award to review HHS procedures, processes and expectations, as well as Contractor’s development data and plans. Program assessment will be performed by qualified subject matter experts in clinical development, engineering, manufacturing, quality control, regulatory affairs, etc. |
Contracting Officer | Contracting Officer Technical Representative |
HHS/ASPR/AMCG | HHS/ASPR/BARDA |
330 Independence Avenue, S.W. | 330 Independence Avenue, S.W. |
Room G644 | Room G644 |
Washington, DC 20201 | Washington, DC 20201 |
Email: | Email: |
FAR Source | Title and Date | ||||
FAR Clause 52.243-1 | Changes – Fixed Price (Aug 1987) | ||||
FAR Clause 52.246-1 | Contractor Inspection Requirements (Apr 1984) | ||||
FAR Clause 52.246-2 | Inspection of Supplies – Fixed Price (Aug 1996) | ||||
FAR Clause 52.246-8 | Inspection of R& D – Cost Reimbursement (May 2001) | ||||
FAR Clause 52.246-16 | Responsibility of Supplies (Apr 1984) |
FAR Clause | Title and Date | ||||
FAR 52.211-17 | Delivery of Excess Quantities (Sept 1989) | ||||
FAR 52.242-15 | Stop Work Order (Aug 1989) | ||||
FAR 52.242-15, Alt 1 | Stop Work Order, Alternate 1 (Apr 1984) | ||||
FAR 52.242-17 | Government Delay of Work (Apr 1984) | ||||
FAR 52.247-34 | FOB Destination (Nov 1991) |
F.2.1. | Delivery of smallpox antiviral treatment courses and other deliverables shall be in accordance with FAR 52.247-34 entitled F.O.B. DESTINATION. | ||
F.2.2 | Place of Delivery: The product shall be delivered to a Strategic National Stockpile (SNS) site(s) to be announced prior to time of delivery. | ||
F.2.2.1. | The Contractor shall notify the Contracting Officer in writing at least thirty (30) calendar days prior to each proposed delivery of FDP. After receipt of each notification, the Contracting Officer will either consent or reject that delivery. If the Contracting Officer rejects that delivery, then Contractor shall not make that delivery. Examples of scenarios when the Contracting Officer may reject the Contractor’s request include but are not limited to USG-personnel unavailability, Contractor non-compliances, or USG excusable delays. If the Contracting Officer consents to that delivery, the Contracting Officer will furnish a location for that delivery to the Contractor at least five (5) business days prior to that delivery. | ||
F.2.3. | Unless otherwise specified, deliveries shall be made to the Delivery Point Monday through Friday (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services schedule for delivery on a Federal holiday shall be made the following business day. | ||
F.2.4 | A method (e.g., TempTales) for determining shipping temperatures during transport will be included at appropriate locations with proximity to the product during transit. Data from temperature recording devices will have the capability of being “down-loaded” and read by designated BARDA personnel prior to off-loading of the product at SNS destination. | ||
F.2.5 | Product determined to be out of compliance for shipping temperature specifications will not be accepted or off-loaded from the Contractor’s own or subcontracted conveyance, but will be immediately returned to the manufacturer by the same transport used for delivery. |
F.3.1. | Sample Inspections | |||||
F.3.1.1 | At the discretion of the BARDA and independent of testing conducted by the Contractor, the USG reserves the right to conduct site visits and collect samples of product held by the Contractor and/or stored by the SNS . | |||||
F.3.2. | Disposition of Antiviral Inventory | |||||
F.3.2.1 | Upon expiration or termination (including partial termination) of this Contract, the USG may effect final distribution of any drug produced on this Contract, and remaining in storage at the Contractor’s facility by any one or combination of the following methods: | |||||
a. | The USG may elect to direct the Contractor to ship to a consignee(s) designated by the USG, all drug remaining in storage at the Contractor’s facility. | |||||
b. | The USG may offer the drug to be repurchased by the Contractor at the original purchase price. | |||||
c. | The USG may dispose of the drug in the SNS or direct the Contractor to dispose of unshipped drug developed in support of this contract but in excess of the 1.7 Million courses requested. | |||||
F.3.2.2. | Upon expiration or termination (including partial termination) of this Contract, the USG may effect final distribution of any smallpox antiviral remaining in storage at the Contractor’s facility. Disposition of the product shall be negotiated upon expiration or contract termination. |
Project Bioshield Specific Deliverables | |||||
1. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
2. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
3. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
4. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
5. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
6. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
7. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
8. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
9. | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
Mstn
# |
GO/NO GO Decision Gates | Go Criteria | No-Go Criteria | Deliverable | SOO/WBS# | Date |
[redacted] | ||||||
1 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
2 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
3 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
4 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
5 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
6 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
7 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
8 | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] | [redacted] |
Delivery Number | Number of Doses | FDP Lot Number | Delivery Date |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
[redacted] | [redacted] | [redacted] | |
Total | [redacted] |
[redacted] | |
[redacted] |
Type | Calendar Year | Calendar Year |
2011 | 2011-16 | |
Fringe | N/A | N/A |
OH | N/A | N/A |
G & A | [redacted] | [redacted] |
Fee | [redacted] | [redacted] |
H. 1.1 | The Contractor is hereby notified of the restrictions on the use of HHS funding for lobbying of Federal, State and Local legislative bodies. | |
H.1.2 |
Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions: the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 – Limitations on the Payment of Funds to Influence Federal Transactions and FAR Clause 52.203-12 (Sep 2007).
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H.1.3 |
In addition, the current HHS Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes; 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 or Local legislature except in presentation to the Congress; or any State or Local legislative body itself.
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H.1.4 |
The current HHS Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.
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H. 2.1 | The Representations, Certifications and Other Statements of Contractors submitted by the Contractor dated [redacted] are hereby incorporated by reference, with the same force and effect as if they were given in full text. |
H. 3.1 | The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement shall also be included in any subcontract for services under the contract. |
H. 4.1 |
No information related to data obtained under this contract shall be released or publicized without the prior written consent of the CO, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.
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H. 5.1 |
[redacted]
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H. 6.1 |
No contract involving human subjects research shall be awarded until acceptable assurance has been given that the project or activity will be subject to initial and continuing review by an appropriate institutional review committee(s) as described in 45 CFR Part 46. Contracts involving human subjects will not be awarded to an individual unless 1) the individual is affiliated with or sponsored by an institution that has an Office for Human Research Protections (OHRP) approved assurance of compliance in place and 2) the individual will assume responsibility for safeguarding the human subjects involved. The OHRP web site is:
http://www.hhs.gov/ohrp
. The Contractor further agree to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures that involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.
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H. 6.2 | The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees. | |
H. 6.3 | If at any time during performance of this contract, the Contracting Officer determines, in consultation with the OHRP, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects such noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. | |
H. 6.4 | If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with the OHRP, terminate the contract in whole or in part, and the name of the Contractor may be removed from the list of those Contractors with approved HHS Human Subject Assurances. |
H. 7.1 |
Registration with the U. S. Department of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. The USDA office contact information is available at
http://www.aphis.usda.gov.
The USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.),
http://www.nal.usda.gov/awic/legislat/awa.htm
.
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H. 7.2 |
The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH),
http://grants2.nih.gov/grants/olaw/olaw.htm
. An essential requirement of the PHS Policy
http://grants2.nih.gov/grants/olaw/references/phspol.htm
is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. PHS.
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H.7.3 | The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the USDA under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy. | |
H. 7.4 | The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the Accredited status. As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as its primary evaluation tool. It also uses the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching . It is published by the Federated of Animal Science Societies http://www.fass.org . |
H. 8.1 |
The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the OLAW, establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS. The PHS Policy stipulates that an applicant organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS-supported research activities. Also, the PHS policy defines “animal” as “any live, vertebrate animal used, or intended for use, in research, research training, experimentation, biological testing or for related purposes.” This Policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an institutional animal care and use program. This Policy does not affect applicable State or Local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 USC 2131 et. seq.) and other Federal statutes and regulations relating to animals. These documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163. See
http://grants.nih.gov/grants/olaw/olaw.htm
.
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H. 8.2 |
No PHS-supported work for research involving vertebrate animals will be conducted by an organization, unless that organization is operating in accordance with an approved Animal Welfare Assurance and provides verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed activity in accordance with the PHS policy. Applications may be referred by the PHS back to the institution for further review in the case of apparent or potential violations of the PHS Policy. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the PHS Policy. Foreign applicant organizations applying for PHS awards for activities involving vertebrate animals are required to comply with PHS Policy or provide evidence that acceptable standards for the humane care and use of animals will be met. Foreign applicant organizations are not required to submit IACUC approval but should provide information satisfactory to the Government assuring the humane care and use of such animal.
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H.9.1. |
Before undertaking performance of any contract involving research on live, vertebrate animals, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2316 and 9 CFR Section 2.30.
The Contractor shall furnish evidence of such registration to the Contracting Officer.
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H. 9.2. |
The Contractor shall acquire animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2131-2157 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.
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H.9.3. |
The Contractor agrees that the care and use of any live, vertebrate animals used or intended for use in the performance of this contract will conform with the PHS Policy on Humane Care and Use of Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, and the pertinent laws and regulations of the USDA (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-3). In case of conflict between standards, the more stringent standard shall be used.
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H.9.4. |
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the OLAW, NIH, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (1) through (3) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of\ the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those Contractors with approved PHS Animal Welfare Assurances.
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H.9.5 |
The Contractor may request registration of its facility and a current listing of licensed dealers from the Animal Care Sector Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the sector in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program, may be obtained by contacting: Animal Care Staff USDA/APHIS 4700 River Road, Unit 84 Riverdale, MD 20737 (301) 734-4980. Contractors proposing research that involves live, vertebrate animals will be contacted by OLAW and given detailed instructions on filing a written Animal Welfare Assurance with the PHS. Contractors are encouraged to visit the OLAW website at
http://grants.nih.gov/grants/olaw/olaw.htm
for additional information. OLAW may be contacted at the NIH at (301) 594-2289.
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H. 10.1 |
Under governing regulations, federal funds that are administered by the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (BARDA) shall not be expended by the Contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the Contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office of Laboratory Animal Welfare (OLAW). Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities that do not directly involve live vertebrate animals (i.e. are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by the Contractor or individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional information regarding OLAW may be obtained via the Internet.
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H. 11.1 | The Public Readiness & Emergency Preparedness Act (PREP Act), Pub. L. 109- 148, Division C, 119 Stat. 2818 to 2832, amended the Public Health Service Act, 42, U.S.C. 243 et seq., to provide targeted liability protections. The Government agrees that the medical countermeasure delivered by the Contractor under this contract will not be administered in humans unless the Secretary executes a declaration in accordance with section 319F-3(b) of the Public Health Service Act, 42, U.S.C. 247-d-6d, that the medical countermeasure delivered under this contract is a covered countermeasure to which section 319-F3(a) applies subject to the terms and conditions of the declaration. |
H. 12. 1 | The Current Good Manufacturing Practice Regulations (cGMP) Regulations (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packaging of this product. | |
H. 12. 2 | If at any time during the life of the contract, the Contractor fails to comply with cGMP in the manufacturing, processing and packaging of this product and such failure results in a material adverse effect on the safety, and purity of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Contractor fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated. |
H. 13. 1 | The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract. |
H. 14.1 | The personnel specified in this contract are considered to be essential to the work being performed hereunder. 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 that such diversion and such ratification shall constitute the consent of the Contracting Officer required by this clause. The contract may be modified from time to time during the course of the contract to either add or delete personnel as appropriate. |
Name : | Position: | ||||
1. | [redacted] | [redacted] | |||
2. | [redacted] | [redacted] | |||
3. | [redacted] | [redacted] | |||
4. | [redacted] | [redacted] | |||
5. | [redacted] | [redacted] | |||
6. | [redacted] | [redacted] | |||
7. | [redacted] | [redacted] |
H. 15. 1 |
Work involving select biological agents or toxins shall not be conducted under this contract until the Contractor and any affected subcontractor(s) are granted a certificate of registration or are authorized to work with the applicable select agents.
|
H. 15.2 | For prime or subcontract awards to domestic institutions who possess, use, and/or transfer Select Agents under this contract, the institution must complete registration with BARDA, or APHIS, as applicable, before performing work involving Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR 73, if the final registration certificate is denied. | |
H. 15.3 | For prime or subcontract awards to foreign institutions who possess, use, and/or transfer Select Agents under this contract, the institution must provide information satisfactory to the Government that a process equivalent to that described in 42 CFR 73 ( http://www.cdc.gov/od/sap/docs/42cfr73.pdf ) for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The Contractor must provide information addressing the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73 . The Government will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73 . When requested by the contracting officer, the Contractor shall provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select Agents. This includes summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, the Contractor must access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents under the contract. | |
H. 15.4 | Listings of HHS Select Agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program Web site at http://www.cdc.gov/od/sap/. |
H. 16.1. | Advance payment (up to 10% of the negotiated contract amount) and/or milestone payments (in increments of 5% but not more than 50% of the total negotiated contract amount) have been negotiated and made apart of this contract. | |
H. 16.2 | Approvals for advance payments and or milestone payments have been agreed upon as follows: |
Adanced and Milestone Payments from CLIN-0001 | ||||
# | Payment | Deliverable | Date | Payment |
Milestones | ||||
Advance Payment | ||||
1
|
[redacted] | [redacted] | [redacted] | [redacted] |
Payment Milestones #1 | ||||
1
|
[redacted]
|
[redacted]
|
[redacted]
|
[redacted]
|
2A |
[redacted]
|
[redacted] | [redacted] | [redacted] |
2B
|
[redacted] | [redacted] | [redacted] | [redacted] |
Negotiated Fixed-Price Supply Contract – Applicable to the Fixed Priced CLINS in the schedule. | |||
Reg | Clause | Date | Clause Title |
FAR | 52.202-1 | Jul 2004 | Definitions (Over the Simplified Acquisition Threshold) |
FAR | 52.203-3 | Apr 1984 | Gratuities (Over the Simplified Acquisition Threshold) |
FAR | 52.203-5 | Apr 1984 | Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold) |
FAR | 52.203-6 | Sep 2006 | Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold) |
FAR | 52.203-7 | Oct 2010 | Anti-Kickback Procedures (Over the Simplified Acquisition Threshold) |
FAR | 52.203-8 | Jan 1997 | Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold) |
FAR | 52.203-10 | Jan 1997 | Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold) |
FAR | 52.203-12 | Oct 2010 | Limitation on Payments to Influence Certain Federal Transactions (Over $150,000) |
FAR | 52.204-4 | Aug 2000 | Printed or Copied Double-Sided on Recycled Paper (Over the Simplified Acquisition Threshold) |
FAR | 52.204-7 | Apr 2008 | Central Contractor Registration |
FAR | 52.204-10 | Jul 2010 | Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more) |
FAR | 52.209-6 | Dec 2010 | Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000) |
FAR | 52.211-5 | Aug 2000 | Material Requirements |
FAR | 52.215-2 | Oct 2010 | Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.] |
FAR | 52.215-8 | Oct 1997 | Order of Precedence - Uniform Contract Format |
FAR | 52.215-10 | Oct 2010 | Price Reduction for Defective Cost or Pricing Data (Over $700,000) |
FAR | 52.215-12 | Oct 2010 | Subcontractor Cost or Pricing Data (Over $700,000) |
FAR | 52.215-14 | Oct 2010 | Integrity of Unit Prices (Over the Simplified Acquisition Threshold) |
FAR | 52.215-15 | Oct 2010 | Pension Adjustments and Asset Reversions (Over $700,000) |
FAR | 52.215-18 | Jul 2005 | Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions |
FAR | 52.215-19 | Oct 1997 | Notification of Ownership Changes |
FAR | 52.215-21 | Oct 2010 | Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data – Modifications |
FAR | 52.219-8 | Jan 2011 | Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold) |
FAR | 52.219-9 | Jan 2011 | Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction) |
FAR | 52.219-16 | Jan 1999 | Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction) |
FAR | 52.222-19 | Jul 2010 | Child Labor--Cooperation with Authorities and Remedies |
FAR | 52.222-20 | Oct 2010 | Walsh-Healey Public Contracts Act |
FAR | 52.222-21 | Feb 1999 | Prohibition of Segregated Facilities |
FAR | 52.222-26 | Mar 2007 | Equal Opportunity |
FAR | 52.222-35 | Sep 2010 | Equal Opportunity for Veterans ($100,000 or more) |
FAR | 52.222-36 | Oct 2010 | Affirmative Action for Workers with Disabilities |
FAR | 52.222-37 | Sep 2010 | Employment Reports on Veterans ($100,000 or more) |
FAR | 52.222-40 | Dec 2010 | Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold) |
FAR | 52.222-50 | Feb 2009 | Combating Trafficking in Persons |
FAR | 52.222-54 | Jan 2009 | Employment Eligibility Verification (Over the Simplified Acquisition Threshold) |
FAR | 52.223-6 | May 2001 | Drug-Free Workplace |
FAR | 52.223-14 | Aug 2003 | Toxic Chemical Release Reporting (Over $100,000) |
FAR | 52.223-18 | Sep 2010 | Contractor Policy to Ban Text Messaging While Driving |
FAR | 52.225-1 | Feb 2009 | Buy American Act – Supplies |
FAR | 52.225-13 | Jun 2008 | Restrictions on Certain Foreign Purchases |
FAR | 52.227-1 | Dec 2007 | Authorization and Consent |
FAR | 52.227-2 | Dec 2007 | Notice and Assistance Regarding Patent and Copyright Infringement |
FAR | 52.227-3 | Apr 1984 | Patent Indemnity |
FAR | 52.229-3 | Apr 2003 | Federal, State and Local Taxes (Over the Simplified Acquisition Threshold) |
FAR | 52.232-1 | Apr 1984 | Payments |
FAR | 52.232-8 | Feb 2002 | Discounts for Prompt Payment |
FAR | 52.232-9 | Apr 1984 | Limitation on Withholding of Payments |
FAR | 52.232-11 | Apr 1984 | Extras |
FAR | 52.232-17 | Oct 2010 | Interest (Over the Simplified Acquisition Threshold) |
FAR | 52.232-23 | Jan 1986 | Assignment of Claims |
FAR | 52.232-25 | Oct 2008 | Prompt Payment |
FAR | 52.232-33 | Oct 2003 | Payment by Electronic Funds Transfer--Central Contractor Registration |
FAR | 52.233-1 | Jul 2002 | Disputes |
FAR | 52.233-3 | Aug 1996 | Protest After Award |
FAR | 52.233-4 | Oct 2004 | Applicable Law for Breach of Contract Claim |
FAR | 52.242-13 | Jul 1995 | Bankruptcy (Over the Simplified Acquisition Threshold) |
FAR | 52.243-1 | Aug 1987 | Changes - Fixed-Price |
FAR | 52.244-6 | Dec 2010 | Subcontracts for Commercial Items |
FAR | 52.249-2 | May 2004 | Termination for the Convenience of the Government (Fixed-Price) |
FAR | 52.249-8 | Apr 1984 | Default (Fixed-Price Supply and Service)(Over the Simplified Acquisition Threshold) |
FAR | 52.253-1 | Jan 1991 | Computer Generated Forms |
HHSAR | 352.202-1 | Jan 2006 | Definitions |
HHSAR | 352.203-70 | Jan 2006 | Anti-Lobbying (Over Simplified Acquisition Threshold) |
HHSAR | 352.222-70 | Jan 2010 | Contractor Cooperation in Equal Employment Opportunity Investigations |
HHSAR | 352.227-70 | Jan 2006 | Publications and Publicity |
HHSAR | 352.231-71 | Jan 2001 | Pricing of Adjustments |
HHSAR | 352.242-70 | Jan 2006 | Key Personnel |
HHSAR | 352.242-73 | Jan 2006 | Withholding of Contract Payments |
Negotiated Cost-Reimbursement Service Contract – Applicable to the Cost CLINS in the schedule. | |||
Reg | Clause | Date | Clause Title |
FAR | 52.202-1 | Jul 2004 | Definitions (Over the Simplified Acquisition Threshold) |
FAR | 52.203-3 | Apr 1984 | Gratuities (Over the Simplified Acquisition Threshold) |
FAR | 52.203-5 | Apr 1984 | Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold) |
FAR | 52.203-6 | Sep 2006 | Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold) |
FAR | 52.203-7 | Oct 2010 | Anti-Kickback Procedures (Over the Simplified Acquisition Threshold) |
FAR | 52.203-8 | Jan 1997 | Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold) |
FAR | 52.203-10 | Jan 1997 | Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold) |
FAR | 52.203-12 | Oct 2010 | Limitation on Payments to Influence Certain Federal Transactions (Over $150,000) |
FAR | 52.204-4 | Aug 2000 | Printed or Copied Double-Sided on Recycled Paper (Over the Simplified Acquisition Threshold) |
FAR | 52.204-7 | Apr 2008 | Central Contractor Registration |
FAR | 52.204-10 | Jul 2010 | Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more) |
FAR | 52.209-6 | Dec 2010 | Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000) |
FAR | 52.215-2 | Oct 2010 | Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.] |
FAR | 52.215-8 | Oct 1997 | Order of Precedence - Uniform Contract Format |
FAR | 52.215-10 | Oct 2010 | Price Reduction for Defective Cost or Pricing Data (Over $700,000) |
FAR | 52.215-12 | Oct 2010 | Subcontractor Cost or Pricing Data (Over $700,000) |
FAR | 52.215-15 | Oct 2010 | Pension Adjustments and Asset Reversions (Over $700,000) |
FAR | 52.215-18 | Jul 2005 | Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions |
FAR | 52.215-19 | Oct 1997 | Notification of Ownership Changes |
FAR | 52.215-21 | Oct 2010 | Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data – Modifications |
FAR | 52.215-23 | Oct 2009 | Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold) |
FAR | 52.216-7 | Dec 2002 | Allowable Cost and Payment |
FAR | 52.216-8 | Mar 1997 | Fixed Fee |
FAR | 52.219-8 | Jan 2011 | Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold) |
FAR | 52.219-9 | Jan 2011 | Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction) |
FAR | 52.219-16 | Jan 1999 | Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction) |
FAR | 52.222-2 | Jul 1990 | Payment for Overtime Premium (Over the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.) |
FAR | 52.222-3 | Jun 2003 | Convict Labor |
FAR | 52.222-21 | Feb 1999 | Prohibition of Segregated Facilities |
FAR | 52.222-26 | Mar 2007 | Equal Opportunity |
FAR | 52.222-35 | Sep 2010 | Equal Opportunity for Veterans ($100,000 or more) |
FAR | 52.222-36 | Oct 2010 | Affirmative Action for Workers with Disabilities |
FAR | 52.222-37 | Sep 2010 | Employment Reports on Veterans ($100,000 or more) |
FAR | 52.222-40 | Dec 2010 | Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold) |
FAR | 52.222-50 | Feb 2009 | Combating Trafficking in Persons |
FAR | 52.222-54 | Jan 2009 | Employment Eligibility Verification (Over the Simplified Acquisition Threshold) |
FAR | 52.223-6 | May 2001 | Drug-Free Workplace |
FAR | 52.223-14 | Aug 2003 | Toxic Chemical Release Reporting (Over $100,000) |
FAR | 52.223-18 | Sep 2010 | Contractor Policy to Ban Text Messaging While Driving |
FAR | 52.225-1 | Feb 2009 | Buy American Act – Supplies |
FAR | 52.225-13 | Jun 2008 | Restrictions on Certain Foreign Purchases |
FAR | 52.227-1 | Dec 2007 | Authorization and Consent |
FAR | 52.227-2 | Dec 2007 | Notice and Assistance Regarding Patent and Copyright Infringement |
FAR | 52.227-14 | Dec 2007 | Rights in Data – General |
FAR | 52.232-9 | Apr 1984 | Limitation on Withholding of Payments |
FAR | 52.232-17 | Oct 2010 | Interest (Over the Simplified Acquisition Threshold) |
FAR | 52.232-20 | Apr 1984 | Limitation of Cost |
FAR | 52.232-23 | Jan 1986 | Assignment of Claims |
FAR | 52.232-25 | Oct 2008 | Prompt Payment, Alternate I (Feb 2002) |
FAR | 52.232-33 | Oct 2003 | Payment by Electronic Funds Transfer--Central Contractor Registration |
FAR | 52.233-1 | Jul 2002 | Disputes |
FAR | 52.233-3 | Aug 1996 | Protest After Award, Alternate I (Jun 1985) |
FAR | 52.233-4 | Oct 2004 | Applicable Law for Breach of Contract Claim |
FAR | 52.242-1 | Apr 1984 | Notice of Intent to Disallow Costs |
FAR | 52.242-3 | May 2001 | Penalties for Unallowable Costs (Over $700,000) |
FAR | 52.242-4 | Jan 1997 | Certification of Final Indirect Costs |
FAR | 52.242-13 | Jul 1995 | Bankruptcy (Over the Simplified Acquisition Threshold) |
FAR | 52.243-2 | Aug 1987 | Changes - Cost Reimbursement, Alternate I (Apr 1984) |
FAR | 52.244-2 | Oct 2010 | Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007) |
FAR | 52.244-5 | Dec 1996 | Competition in Subcontracting (Over the Simplified Acquisition Threshold) |
FAR | 52.244-6 | Dec 2010 | Subcontracts for Commercial Items |
FAR | 52.245-1 | Aug 2010 | Government Property |
FAR | 52.245-9 | Aug 2010 | Use and Charges |
1. | Summary of Related Activities | |
2. | Protection of Human Subjects | |
3. | Disclosure of Lobbying Activities | |
4. | Invoice Instructions for Fixed Price Contracts | |
5. | Contractor Performance Evaluation Report | |
6. | ACH Vendor/Miscellaneous Payment Enrollment Form | |
7. | Security and Information Technology Plan Requirements | |
8. | Risk Mitigation Plan/Matrix Template | |
9. | Work Breakdown Structure Template | |
10. | Integrated Master Schedule Template | |
11. | Subcontracting Plan | |
12. | 7 Principles Tier 2 System Implementation Intent Guide |
a. | Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals * in this proposal. | |||||
Professional's Name and Title/Position : | ||||||
Identifying Number | Agency | Total Effort Committed | ||||
1. | ||||||
2. | ||||||
3. | ||||||
4. | ||||||
* If an individual has no obligation(s), so state. | ||||||
b. | Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals * . | |||||
Professional's Name and Title/Position : | ||||||
Identifying Number | Agency | Total Effort Committed | ||||
1. | ||||||
2. | ||||||
3. | ||||||
4. | ||||||
* If no commitment of effort is intended, so state. | ||||||
c. | Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal. | |||||
Name | Title/Position | Total Proposed Effort | ||||
1. | ||||||
2. | ||||||
3. | ||||||
4. |
Policy : Research activities involving human subjects may not be conducted or supported by the Departments and Agencies adopting the Common Rule (56FR28003, June 18, 1991) unless the activities are exempt from or approved in accordance with the Common Rule. See section 101(b) of the Common Rule for exemptions. Institutions submitting applications or proposals for support must submit certification of appropriate Institutional Review Board (IRB) review and approval to the Department or Agency in accordance with the Common Rule. | Institutions must have an assurance of compliance that applies to the research to be conducted and should submit certification of IRB review and approval with each application or proposal unless otherwise advised by the Department or Agency . |
DISCLOSURE OF LOBBYING ACTIVITIES | Approved by OMB 0348-0046 |
Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352
(See reverse for public burden disclosure) |
1. Type of Federal Action: | 2. Status of Federal | 3. Report Type: | ||||
a. contract | a. bid/offer/application | a. initial filing | ||||
b. grant | b. Initial award | b. material change | ||||
c. cooperative
d. loan e. loan guarantee f. loan insurance |
c. post-award |
For Material Change Only:
year ______ quarter______ date of last report ______ |
1. | Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action. | ||||
2. | Identify the status of the covered Federal action. | ||||
3. | Identify the appropriate classification of this report. If this is a follow-up report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action. | ||||
4. | Enter the full name, address, city, state and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants. | ||||
5. | If the organization filing the report in item 4 checks "Subawardee," then enter the full name, address, city, state and zip code of the prime Federal recipient. Include Congressional District, if known. | ||||
6. | Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department of Transportation, United States Coast Guard. | ||||
7. | Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments. | ||||
8. | Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number, Invitation for Bid (IFB) number, grant announcement number, the contract, grant, or loan award number, the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., "RFP-DE-90-001." | ||||
9. | For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5. | ||||
10. | (a) | Enter the full name, address, city, state and zip code of the lobbying entity engaged by the reporting entity identified in item 4 to influence the covered Federal action. | |||
(b) | Enter the full names of the individual(s) performing services, and include full address if different from 10(a); Enter Last Name, First Name, and Middle Initial (MI). |
11. | Enter the amount of compensation paid or reasonably expected to be paid by the reporting entity (item 4) to the lobbying entity (item 10). Indicate whether the payment has been made (actual) or will be made (planned). Check all boxes that apply. If this is a material charge report, enter the cumulative amount of payment made or planned to be made. | ||||
12. | Check the appropriate box(es). Check all boxes that apply. If payment is made through an in-kind contribution, specify the nature and value of the in-kind payment. | ||||
13. | Check the appropriate box(es). Check all boxes that apply. If other, specify nature. | ||||
14. | Provide a specific and detailed description of the services that the lobbyist has performed, or will be expected to perform, and the date(s) of any services rendered. Include all preparatory and related activity, not just time spent in actual contact with Federal officials. Identify the Federal official(s) or employee(s) contacted or the officer(s), employee(s), or Member(s) of Congress that were contacted. | ||||
15. | Check whether or not a SF-LLL-A Continuation Sheet(s) is attached. | ||||
16. | The certifying official shall sign and date the form, print his/her name, title and telephone number. |
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, D.C. 20503. |
Evaluation Type: Interim __Final __ ( check one) | ||
Evaluating Organization: | Reporting Period: From to | |
Contracting Office: | Contract Number: | Order Number: |
Contractor Name:
|
Contractor Address:
|
|
DUNS: | City: | State: |
Additional or Alternate Contractor Name:
|
Zip/Postal Code:
|
Country:
|
TIN: | Industrial Code (NAICS): | Commodity Code: | Contract Type: |
Contract Award Date: | Contract Expiration Date: | Contract Value: |
Requirement Description: |
Quality of Product or Service |
_0=Unsatisfactory _1=Poor _2=Fair _3=Good _4=Excellent _5=Outstanding |
Government Comments for Quality of Product or Service (2000 characters maximum): |
Cost Control ( Rating and Comments for Cost Control are not required if contract type is Fixed-Price) |
_0=Unsatisfactory _1=Poor _2=Fair _3=Good _4=Excellent _5=Outstanding |
Government Comments for Cost Control (2000 characters maximum): |
Timeliness of Performance |
_0=Unsatisfactory _1=Poor _2=Fair _3=Good _4=Excellent _5=Outstanding |
Government Comments for Timeliness of Performance (2000 characters maximum): |
Business Relations |
_0=Unsatisfactory _1=Poor _2=Fair _3=Good _4=Excellent _5=Outstanding |
Government Comments for Business Relations (2000 characters maximum): |
Unsatisfactory | Non-conformances are jeopardizing the achievement of contract requirements, despite use of Agency resources. Recovery is not likely. If performance cannot be substantially corrected, it constitutes a significant impediment in consideration for future awards containing similar requirements. |
Poor | Overall compliance requires significant Agency resources to ensure achievement of contract requirements. |
Fair | Overall compliance requires minor Agency resources to ensure achievement of contract requirements. |
Good | There are no, or very minimal, quality problems, and the Contractor has met the contract requirements. |
Excellent | There are no quality issues, and the Contractor has substantially exceeded the contract performance requirements without commensurate additional costs to the Government. |
Outstanding | The contractor has demonstrated an outstanding performance level that was significantly in excess of anticipated achievements and is commendable as an example for others, so that it justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances where contractor performance clearly exceeds the performance levels described as "Excellent". |
Unsatisfactory | Ability to manage cost issues is jeopardizing performance of contract requirements, despite use of Agency resources. Recovery is not likely. If performance cannot be substantially corrected, this level of ability to manage cost issues constitutes a significant impediment in consideration for future awards. |
Poor | Ability to manage cost issues requires significant Agency resources to ensure achievement of contract requirements. |
Fair | Ability to control cost issues requires minor Agency resources to ensure achievement of contract requirements. |
Good | There are no, or very minimal, cost management issues and the Contractor has met the contract requirements. |
Excellent | There are no cost management issues and the Contractor has exceeded the contract requirements, achieving cost savings to the Government. |
Outstanding | The contractor has demonstrated an outstanding performance level that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances where the contractor achieved cost savings and performance clearly exceeds the performance levels described as "Excellent". |
Unsatisfactory | Delays are jeopardizing the achievement of contract requirements, despite use of Agency resources. Recovery is not likely. If performance cannot be substantially corrected, it constitutes a significant impediment in consideration for future awards. |
Poor | Delays require significant Agency resources to ensure achievement of contract requirements. |
Fair | Delays require minor Agency resources to ensure achievement of contract requirements. |
Good | There are no, or minimal, delays that impact achievement of contract requirements. |
Excellent | There are no delays and the contractor has exceeded the agreed upon time schedule. |
Outstanding | The contractor has demonstrated an outstanding performance level that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances where contractor performance clearly exceeds the performance levels described as "Excellent". |
Unsatisfactory | Response to inquiries and/or technical, service, administrative issues is not effective. If not substantially mitigated or corrected it should constitute a significant impediment in considerations for future awards. |
Poor | Response to inquiries and/or technical, service, administrative issues is marginally effective. |
Fair | Response to inquiries and/or technical, service, administrative issues is somewhat effective. |
Good | Response to inquiries and/or technical, service, administrative issues is consistently effective. |
Excellent | Response to inquiries and/or technical, service, administrative issues exceeds Government expectation. |
Outstanding | The contractor has demonstrated an outstanding performance level that justifies adding a point to the score. It is expected that this rating will be used in those rare circumstances where contractor performance clearly exceeds the performance levels described as "Excellent". |
Check one of the following: | ||
c Federal Employee: c Contractor: c Vendor: | ||
Name: | ||
Business | ||
Address: | ||
Remit To | ||
(If same as above, leave blank. Must match address on invoice for internal control purposes.) | ||
Address: | ||
The following information must be completed by your financial institution representative: |
The following information must be completed by your financial institution representative: |
2. Name of Financial | ||
Institution: | ||
3. Address of Financial | ||
Institution: | ||
4. Financial Institution's 9-digit ABA Routing Number for | |
Transfer of Funds: ___ ___ ___ ___ ___ ___ ___ ___ ___ | |
5. Depositor Account Title: |
6. Depositor Account Number: |
7. Type of Account: | c Checking | c Savings |
8. Signature and Title of Authorized Official of Financial Institution: | ||
Telephone Number: (_____) ____________________ Date: ____________ |
************ The following must be signed by the payee************** | |||||
I have verified the information on this form. | |||||
Signature | Date | ||||
Signature | Date | ||||
1. | WBS # | |
2. | Control Account # | |
3. | Work Package # | |
4. | Activity # (if different from WP #) | |
5. | Task Description | |
6. | Baseline Start | |
7. | Baseline Finish | |
8. | Forecast Start | |
9. | Forecast Finish | |
10. | Actual Start | |
11. | Actual Finish | |
12. | Predecessor | |
13. | Successor |
[redacted] | |
1. | Plan all work scope for the program to completion of the contract. | ||
2. | Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives. | ||
3. | Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline. | ||
4. | Use actual cost incurred and recorded in accomplishing the work performed. | ||
5. | Objectively assess accomplishments at the work performance level. | ||
6. | Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed. | ||
7. | Use Performance Based information in the company's management processes. |
a) | Description of the work scope through Work Breakdown Structure Dictionary/Work Authorization Documents at WBS Level 3; | ||
b) | An Integrated Master Schedule (IMS) with the inclusion of agreed major milestones; | ||
c) | A control account plan (CAP) for all control accounts; | ||
d) | Baseline revision documentation and program logs; | ||
e) | And a risk register. |
a) | The Contractor shall deliver an Earned Value Contract Performance Report (EV-CPR) on monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/). Contractor shall provide preliminary EV-CPR, Format 1, on the 15th business day after end of Contractor reporting period and final EV-CPR and Format 1 and Format 5 (VARs) and a supplemental Control Account Plan (CAP) report on the 20th business day after end of Contractor reporting period. The variance narrative reports shall describe what the variance and indices may be indicating regarding the over all performance, the reasons for the variances, the adequacy of corrective action plans, and forecasts of future performances. The USG shall use best efforts to respond within 5 business days. | ||
b) |
The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)) and actual costs of work performed (ACWP) as captured in
Contractor’s EVM systems. The contractor shall provide a rational in the package of its use of % complete as EVMS methodology or identity if any other EVMS methodology is being used.
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