RFP for lab services.pdf

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 350)

RATING PAGE OF PAGES

1 | 52

2. CONTRACT (Proc. Inst. Ident.) NO.

3. SOLICITATION NO.

10-100-SOL-00001

4. TYPE OF SOLICITATION

[ ] SEALED BID (IFB)

[x] NEGOTIATED (RFP)

5. DATE ISSUED

2/21/2010

6. REQUISITION/PURCHASE NO.

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than item 7) Department of Health and Human Services

OS/ASPR/AMCG

330 Independence Avenue, SW, Room G644 Washington, DC 20201

NOTE: In sealed bid solicitation "offer" and "offeror” mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and see Attachment #1 copies for furnishing the supplies or services in the Schedule will be received at the place specificed, in the depository located in until February 26, 2010 local time 03:00 pm.

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L. Provision No. 52.215-1. All offers are subject to all tems and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Brenda Brooks Contracting Officer

B. TELEPHONE (NO COLLECT

CALLS)

AREA CODE NUMBER EXT

202-260-1460

C. E-MAIL ADDRESS

brenda.brooks@hhs.gov

11. TABLE OF CONTENTS

(x) SEC. DESCRIPTION PAGE(S) (x) SEC. DESCRIPTION PAGE(S

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 17

X B SUPPLIES OR SERVICE AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACH.

X C DESCRIPTION/SPECS/WORK STATEMENT 5 X J LIST OF ATTACHMENTS 21

X D PACKAGING AND MARKETING 9 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 10 X K REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 11 OTHER STATEMENTS OF OFFERORS 22

X G CONTRACT ADMINISTRATION 12 X L INSTRS., COND., AND NOTICES TO OFFERORS 23

X H SPECIAL CONTRACT REQUIREMENTS 14 X M EVALUATION FACTORS FOR AWARD 41

OFFER (Must be fully completed by offeror) NOTE: ITEM 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 120 calendar days (120 calendar days unless a different period is inseted by the offer) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT SEE 14

(See section I, Clause No 52.232-8)

10 CALENDAR

DAYS

20 CALENDAR DAYS

30 CALENDAR

DAYS

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS AMENDMENT NO. DATE AMENDMENT NO. DATE

(The offeror acknowledges receipt of amendments to the solicitation and related documents ) numbered and dated:

15A. NAME CODE FACILITY 16. NAME AND TITLE OF PERSON AUTHORIZED

AND

ADDRESS

OF

OFFEROR

TO SIGN OFFER (Type or print)

15B. TELEPHONE NO. (Include area code)

15C. CHECK IF REMITTANCE

ADDRESS [ ] IS DIFFERENT FROM

ABOVE - ENTER SUCH ADDRESS

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEM NUMBERED

20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

[ ] 10 U.S.C. 2304(c)( ) [ ] 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTRATION BY (If other than Item 7)

CODE

25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT - Award will be made on this form, or on the Standard Form 26, or by other authorized official written notice.

NSN 7540-01-152-8064 STANDARD FORM 33 (REV 9-97)

PREVIOUS EDITION NOT USABLE Prescribed by GSA

RFP No. 10-100-SOL-00001 Page 2

SECTION B--SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for laboratory testing services. It is anticipated that firm fixed price and/or time and materials task orders will be issued under this contract. The purpose of this acquisition is to engage laboratory testing services to enable understanding hypothetical analytical and biological effects on various influenza test systems. Laboratory testing services will enable systematic assessment of the contribution of identified variables under controlled testing conditions using standardized methods and validated processes. Additionally laboratory resources will be utilized to prepare samples that can by used by USG programs, developers, and manufacturers.

B.2. CONTRACT LINE ITEM NUMBERS (CLINs)

A. BASE CONTRACT

(1) FIRM FIXED PRICE CLIN

ITEM SUPPLIES/SERVICES QTY / UNIT UNIT

PRICE

0001 Laboratory services with established Firm Fixed Prices, and Technical Reports on task orders Services are to be determined (TBD).

See Section F for further details on reporting requirements.

$ TBD

(2) TIME-AND-MATERIALS CLIN

The hourly rates proposed for each labor category shall be fully burdened rates, including any indirect or overhead rates applicable. The fully burdened hourly rates will be incorporated into any resultant contract awards under B.4. Advance Understandings, and must be used for budgeting task orders and reimbursement of labor costs on Time-and-Materials task orders.

For the below CLIN, a cost breakdown is needed:

ITEM SUPPLIES/SERVICES QTY / UNIT NOT-TO-

EXCEED

AMOUNT

0002 Laboratory services, Time-and-Materials, and Technical Reports on task orders

Services are to be determined (TBD).

See Section F for further details on reporting

B. CONTRACT OPTIONS

ITEM SUPPLIES/SERVICES QTY / UNIT UNIT PRICE

(FIRM-FIXED PRICE)

OR NOT-TO-EXCEED

AMOUNT (TIME AND

MATERIALS)

0003 Option Year 1, Laboratory services with established

Firm Fixed Prices, and Technical Reports on task orders

Services are to be determined (TBD).

See Section F for further details on reporting

RFP No. 10-100-SOL-00001 Page 3

0004 Option Year 1, Laboratory services, Time-and- Materials, and Technical Reports on task orders

Services are to be determined (TBD).

See Section F for further details on reporting

0005 Option Year 2, Laboratory services with established Firm Fixed Prices, and Technical Reports on task orders

Services are to be determined (TBD).

See Section F for further details on reporting

0006 Option Year 2, Laboratory services, Time-and- Materials, and Technical Reports on task orders

Services are to be determined (TBD).

See Section F for further details on reporting

B.3. PROVISIONS APPLICABLE TO DIRECT COSTS (Time-and-Materials CLINs only)

(1) This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Travel Costs; 2) Consultant Costs;

3) Subcontract Costs; 4) Accountable Government Property; and 5) Research Funding.

(2) The contractor will be reimbursed by the government for long distance travel expenses incurred by contractor personnel specifically authorized to travel for contract purposes. All travel will be in accordance with Federal Travel Regulations.

Travel authorization will be provided in the Task Order. The government will not pay for travel unless specifically authorized in writing, in advance. All travel performed shall not exceed the dollar amount indicated in the Task Order.

Local travel within a 50-mile radius of the Contractor’s office will not be reimbursed and such costs should be included in the price of the contract.

B.4. ADVANCE UNDERSTANDINGS

1. Government-furnished Property

a. If applicable, contractors will receive instructions for obtaining from the U.S. Government specific samples for analytic testing. These samples will be provided either as live cultures or as inactivated material. Live Influenza H5N1 viruses can be provided to contractors that have BSL-3 enhanced laboratories and an established Select Agent Program.

Genetically modified (biosafety level 2) live Influenza H5N1 reassortant viruses that inherited the modified hemagglutinin and neuraminidase genes from H5N1 viruses and other (internal) genes from donor strains can be provided. When not furnished by the US Government, other sources for samples may be used. In addition to highly pathogenic influenza viruses, novel influenza viruses and other respiratory pathogens may also be provided.

b. Capital expenditures for land or buildings shall not be allowable. In addition, capital expenditures for improvements to land, buildings, or equipment which materially increase their value or useful life shall not be allowable.

2. Fully loaded labor rates for key personnel in the base and option years will be determined prior to contract award and listed in the below table. Accordingly they shall be used by the Contractor as the ceiling labor rates when submitting price proposals in response to requests for task order issued under these contracts. Also these rates serve as ceilings for the reimbursement of labor costs on Time-and-Materials task orders. Contractors may propose at or below these labor rates, as each task order award will be negotiated on an individual basis. Hourly rates proposed for each labor category shall be fully burdened rates, including any indirect or overhead rates applicable. The fully burdened hourly rates will be used to authorize Fixed Price Orders.

RFP No. 10-100-SOL-00001 Page 4

LABOR CLASSIFICATIONS HOURLY RATE

YEAR ONE

HOURLY

RATE YEAR

TWO

HOURLY RATE

YEAR THREE

OPTION YEAR

FOUR

OPTION YEAR

FIVE

3. Task Order Procedures

It is understood and agreed that the procedures for awarding task order contained in Attachment #5 apply to this contract

B.5. MINIMUM AND MAXIMUM ORDER LIMITATIONS

1. The minimum ordering limitation and Government guarantee under this contract is $10,000.

2. The maximum ordering limitation under this contract is $4,100,000.00.

B.6. FULFILLING MINIMUM ORDERING REQUIREMENTS

The Government has no obligation to issue Task Orders to any Contractor beyond the minimum amount specified above. For each successful contractor there will be a one time “minimum guarantee award amount” during the life of the contract which includes all option years, if exercised. This amount can only be claimed at the end of the contract period if the contractor takes advantage of fair opportunity, as described in FAR 16.505, by proposing on at least one Task Order per year.

B.7. FUNDING

Funds for the services provided will be obligated, at the task order level, as they become available, or excess funds de-obligated at the task order level, by modification to the task order contracts unilaterally by the Government. The contractor will only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed if the Contractor meets the requirements as stated in B.6. Withholding.

B.8. WITHHOLDING

Pursuant to FAR 32.501-1(a), the progress payments for fixed priced task orders will include a payment-withholding rate of 20% of the task order price for large businesses and 15% of the task order price for small businesses during the base and option periods, if exercised.

Withholding of payments may occur for fixed priced task orders if deliverables are determined to be unacceptable and/or the performance of services required are not performed at a satisfactory level.

B.9. PRICING OF TASK ORDERS

Individual Task Orders will be issued as requirements occur. Task Orders will specify work to be performed and will reflect the labor rates of the proposed staff in effect when the task order is issued (in accordance with the Advanced Understanding to be included in the contract awards). The Contractor shall perform all services in accordance with each task order’s work statement/specifications. The terms and conditions set forth in the contracts will always apply. All Task Orders will be either fixed price or time-and-materials.

RFP No. 10-100-SOL-00001 Page 5

SECTION C - DESCRIPTION/SPECIFICATIONS

C.1. STATEMENT OF OBJECTIVES

A. Background

The Department of Health and Human Services, ASPR/BARDA, supports advanced development of countermeasures for diagnosis of pandemic influenza in order to meet clinical and public health needs. As part of the strategic plan for pandemic preparedness, the Center for Disease Control and Prevention (CDC) and the Assistant Secretary for Preparedness and Response (ASPR) recognize the need for rapid, reliable and accurate, laboratory-based and Point-of-Care influenza diagnostic test systems.

These may detect emerging pandemic influenza viruses and distinguish A/H5, other novel influenza A virus subtypes, from other respiratory viruses that cause clinical indistinguishable diseases. BARDA will engage qualified laboratories to perform specific in-vitro laboratory services (issued as task orders) that will support pandemic influenza diagnostic programs.

B. Purpose

The purpose of this acquisition is to engage laboratories to perform specific in vitro laboratory services (issued as task orders) that will support HHS/CDC pandemic influenza diagnostic programs. Such resources will enable testing to understand hypothetical analytical and biological effects on various in vitro influenza diagnostic test systems. Laboratory testing services will enable systematic assessment of the contribution of identified variables under controlled conditions using standardized methods and validated processes. Additionally, such laboratory resources will be utilized to enable the preparation of samples that can be used by USG programs, developers, and manufacturers for systematic assessment of variables affecting influenza diagnostic test system performance.

A specific example is that published reports document variable sensitivity of currently available rapid influenza tests for detecting influenza viruses in clinical specimens from infected individuals. Other influenza diagnostic tests may also have variable performance in different settings and test populations. The following variables, alone or in combination, may impact the benefit of rapid and other influenza tests in clinical practice, seasonal outbreaks and pandemic:

• Changes with circulating influenza virus over multiple seasons (e.g., antigenic drift in regions targeted by specific monoclonal antibodies).

• Changes with the reference standard (e.g., shift from use of viral culture to PCR techniques or differences with cell culture methodologies and viral permissiveness in different cell culture lines).

• Variation in formulation of rapid tests.

• Changes in clinical practices (e.g., tests used more widely and increasingly for less acutely ill individuals in outpatient settings; and for guiding antiviral use).

• Changes with susceptibility to infection (host immunological responses).

Identifying factors that affect rapid test performance can assist public health decisions, practice guidelines, development strategies, and design of future performance evaluation protocols using advanced scientific evidence.

C. Contract Objectives

The contractor shall conduct laboratory testing and in-vitro procedures that will enable systematic assessment of the contribution of identified variables under controlled testing conditions using standardized methods and validated processes. The contractor shall provide all necessary labor, materials, equipment, and experienced personnel not otherwise provided by the Government.

Laboratory testing services may include, but not be limited to:

1) acquiring and maintaining viral and clinical samples for performing analytical evaluations.

2) preparing and characterizing samples that can be used in testing protocols, or used by others (e.g., developers and outside laboratories).

3) performing laboratory analytical evaluations of influenza test systems, including influenza point-of-care tests.

RFP No. 10-100-SOL-00001 Page 6

D. Contract Options

The Period of Performance for the base contract is three years (36 months) from the date of award of contract. The contract also provides for two additional option periods of one year (12 months) each.

E. Technical Requirements and Constraints

The Contractor shall provide the following facilities and resources for performing anticipated laboratory services:

1. BSL2 laboratory facilities with BSL3 practices and equipment to receive, propagate, aliquot, store and characterize infectious influenza virus titer by endpoint dilution, and inoculation into Madin-Darby Canine Kidney (MDCK) cells to establish the median tissue culture infectious dose (TCID50) of the stock materials used to prepare dilutions and aliquots for testing.

2. USDA-approved BSL-3 enhanced containment facility, personnel and SOPs for handling open containers of live wild type, highly pathogenic influenza viruses (required at the time of task order award). The Contractor must comply with all applicable HHS and USDA safety requirements and must show evidence of appropriate biosafety containment and Select Agent Program compliance if applicable. BSL-3-enhancements and need for USDA permits and select agent needs when working with live virus are described at:

http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm , http://www.ocio.usda.gov/directives/doc/DM9610- 001.pdf and http://www.aphis.usda.gov/permits/index.shtml.

3. Appropriate BSL-2 laboratory facilities for performing testing with influenza diagnostic products and other laboratory procedures using prepared viral and clinical samples.

4. Protective garments, equipment and appropriate training and monitoring to assure safe handling of biohazard materials.

Specifically, the Contractor shall comply with all applicable health and safety regulations (http://www.cdc.gov/od/ohs/biosfty/biosfty.htm) while conducting the applicable work set forth herein and follow the standards to be specified in individual task orders.

5. Personnel experienced and proficient in performing required BSL-2 and BSL-3-Enhanced activities (propagation, dilution and aliquoting of highly pathogenic virus samples) and laboratory technicians or technologists with required training for preparing, and characterizing samples, and for performing testing with influenza diagnostic products.

6. Technical competence for the propagation and characterization of influenza viruses (i.e., Ph.D. or equivalent research experience in virology, and clinical laboratory diagnostic testing).

7. Validated laboratory procedures for viral culture and characterizing influenza viruses and other respiratory pathogens;

and capability to validate additional procedures that may be needed.

8. Experienced support personnel as needed to assist with preparing specified protocols and reports.

9. State-of-the-art data management tools and practices to maintain integrity and security of information related to results from analytical evaluation activities.

10. Capability to draft testing plan protocols and design analytical approaches including applicable statistics for data analysis and interpretation.

The following is a list of testing or procedures that could be required by this contract upon issuance of a task order:

a) Propagate both seasonal and non-seasonal (novel) influenza viruses (i.e., viral culture with cell culture lines, eggs, etc.).

b) Verify identity of propagated viruses.

c) Quantify propagated viruses (titrations by PFU, TCID50, or equivalent).

d) Characterize viral protein (PAGE, hemagglutinin titrations, Western Blot, bicinchoninic acid, or other reference assays.)

e) Characterize viral nucleic acids (sequencing, spectrophotometric analysis, real time PCR target analysis and cycle threshold values, etc.)

RFP No. 10-100-SOL-00001 Page 7

f) Prepare virus samples with culture supernatants and infected cells in specified matrices and over specified dilutions.

g) Acquire and receive essential materials, reagents, instrumentation, recommended controls; maintain all reagents and materials for testing under recommended storage conditions prior to use.

h) Inactivate viral preparations for transfer to other facilities as needed.

i) Perform testing with FDA-cleared or investigational influenza tests, and prepared characterized samples or available clinical samples in accordance with accepted protocol.

j) Prepare protocol and testing plan for review and acceptance by Project Officer prior to proceeding (within 3 weeks of task order).

k) Document all findings in accordance with accepted procedures or test directions for use; transfer to an Excel spreadsheet.

l) Summarize findings in tabular and graphical formats to accompany spreadsheet line data.

m) Prepare a draft report for each task order within 14 days of completing a test series. This report shall include summary analyses, in accordance with the protocol and testing plan.

n) Provide a final report within 14 days after discussions with, and approval of the draft report by the Project Officer.

o) Transfer requested samples to authorized receivers in accordance with all applicable regulations.

p) If requested by the Project Officer, the contractor shall provide samples to designated laboratories for external evaluations, or use in testing at other qualified facilities.

q) Coordination with other investigators to standardize procedures and protocol designs used for evaluations or publication.

F. Minimal Qualifications

Initial proposals submitted in response to the RFP must demonstrate that the offeror possesses the minimal qualifications.

Technical proposals that do not demonstrate that the offeror possesses these qualifications will not be subject to further Proposal Review, including a review of the offeror’s past performance, or otherwise be considered for award. The minimum qualifications are:

1. Offeror must possess necessary licenses, certifications, clearances to perform testing with a range of influenza viruses and other respiratory pathogens.

2. Offeror must perform laboratory work within the confines of their place of business at one location.

3. Offerors must comply to a quality system (e.g., ISO 9001) or regulation with third party review and/or certification (e.g., a copy of the latest quality audit including any adverse findings and corrective action taken).

4. Designated personnel must be trained to comply with current IATA and DOT requirements for shipping infectious materials.

All information regarding the testing shall be the property of USG/HHS and treated as such. The Project Officer shall be responsible for determining the level of information and data regarding testing done that will be made available for dissemination and to whom the information will be made available. Material Transfer Agreements and Confidentiality Disclosure Agreements may be needed for material or information transferred that USG/HHS or providers of influenza diagnostics consider to have intellectual property value, or that is covered under patent application. All records, samples, and other documents must be available for inspection during site visits of the facilities.

Contractors can receive instructions for obtaining from the U.S. Government specific virus samples, or other microorganisms, for seed stock or analytic testing. These samples will be provided either as live cultures or as inactivated material. Live Influenza H5N1 viruses can be provided to contractors that have BSL-3 enhanced laboratories and an established Select Agent Program.

Genetically modified (biosafety level 2) live Influenza H5N1 reassortant viruses that inherited the modified hemagglutinin and neuraminidase genes from H5N1 viruses and other (internal) genes from donor strains can also be available. Novel influenza viruses and other samples may also be available.

RFP No. 10-100-SOL-00001 Page 8

C.2. REPORTING REQUIREMENTS AND DELIVERABLES

A. Interim reports on each task order – At least every two (2) months during a performance period for a task order, the

Contractor shall submit a brief summary of work performed, not limited to the following:

(1) Protocols developed and submitted for approval,

(2) Feedback on testing capacity,

(3) A summary of activities under terms of the contract,

(4) Technical or administrative issues encountered, and their resolution or proposed corrective action.

B. Draft of a final report, including a summary analyses, for each task order: The draft report shall be submitted within 14 days of completing a testing service project, in Microsoft Word, with Microsoft Excel line data attachments as applicable. The reports will be reviewed by the Project Officer within 14 days, and input will be provided at that time if applicable. Such reports shall include the following:

1. Title Page containing contract number and title, period of performance, contractor’s name and address, author(s) and date of submission.

2. An abstract with an overview description of the experiments, samples used, and results.

3. Introduction/Background – An introduction covering the purpose and scope of the laboratory services performed.

4. Issues – describe issues with testing or sample preparation procedures, and protocol deviations. Include details of issues, problem investigation, and mitigation.

5. Data summaries (and method of analysis as applicable).

6. Attachments:

a. Reports, protocols, and/or SOPs developed or used on the project.

b. Listing of internal meetings and/or conference calls to address outstanding concerns with the specific task order.

c. A summary of reagents and materials acquired.

d. Accounting and disposition of remaining reagents and materials acquired.

e. Listing of materials distributed or returned to original source.

C. Final Report for each task order:

The final report shall be submitted within 14 days after the draft report is accepted by the Project Officer. This report documents and summarizes activities and results (as described above) for each laboratory service task order along with:

(1) Edits or revisions discussed with Project Officer;

(2) Labeled and inventoried paper files of all laboratory activities, data files, and any necessary information related thereto; and

(3) Electronic files of protocols developed, laboratory testing activities, data files, data bases, original data and any necessary information related thereto.

D. Annual Report for all task orders: The Contractor shall submit an annual report that summarizes task order activities and capabilities during the base contract’s period of performance. This report shall include:

1. A cover page containing:

a. Contract number and title;

b. Period of performance being reported;

c. Contractor's name and address;

d. Author(s); and

e. Date of submission.

2. A brief summary of the work performed during the reporting period including, but not limited to, the following:

a. Protocols (SOPs) developed and submitted for approval;

b. List of all participating laboratory and administrative personnel and their role in the project.

c. A summary of reagents and materials that were acquired during the contract’s period of performance.

d. Feedback on testing capacity.

e. A summary of activities under terms of the contract.

f. Need for replacement of materials furnished by USG contractor(s).

g. Description of technical or administrative problems encountered during the period of performance, their resolution or the proposed corrective action.

RFP No. 10-100-SOL-00001 Page 9

SECTION D--PACKAGING, MARKING AND SHIPPING

1. Report Deliverables

Unless otherwise specified by the Contracting Officer or the Contracting Officer’s designee, delivery of reports to be furnished to the government under this contract shall be addressed as follows:

Project Officer Contracting Officer

DHHS/OS/ASPR/BARDA DHHS/OS/APSR/AMCG

330 Independence Avenue , S.W. 330 Independence Avenue , S.W Room 640G Room 640G Washington, D.C. 20201 Washington, D.C. 20201

RFP No. 10-100-SOL-00001 Page 10

SECTION E--INSPECTION AND ACCEPTANCE

The Contracting Officer or the duly authorized representative will inspect and accept materials and services to be delivered under the contract. Contractor inspector is hereby noted as the Project Officer and place of inspection will be the contractor’s facilities.

FAR Clause No.52.246-4, INSPECTION OF SERVICES – FIXED PRICE (AUG 1996)

FAR Clause No.52.246-6, INSPECTION, TIME-AND-MATERIAL AND LABOR HOUR (MAY 2001)

RFP No. 10-100-SOL-00001 Page 11

SECTION F--DELIVERIES OR PERFORMANCE

FAR Clauses

1. 52.242-15, Stop-Work Order (AUG 1989)

2. 52.242-17, Government Delay of Work (APR 1984)

3. 52.247-34 F.o.B. Destination (NOV 1991)

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is from the date of contract award to three (3) years after contract award.

Exercise of an option will extend the period of performance by an additional 12 months per contract option. This contract provides for two option periods of 12 months each.

F.2. TECHNICAL REPORT REQUIREMENT

Item Deliverable Quantity Due Date

1. Interim progress report for each task order – every two months during TO performance

1 Electronic Copy – Project Officer (PO);

1 Electronic and 1Hard Copy – Contracting Officer (CO)

By the 15th day following the end of each two month period during task order performance

2. Draft of final report on each task order– 14 days after completion of testing, See above Within 14 days after task order completion

3. C. Final report for each task order – 15 days after draft accepted

1 Electronic Copy and 1 Hard Copy – PO;

1 Electronic Copy and 1 Hard Copy – CO

Within 14 days after draft report is accepted by the Project Officer.

4. Annual Technical Report on all task orders

See above By the 15th day following the end of each contract year.

RFP No. 10-100-SOL-00001 Page 12

SECTION G.--CONTRACT ADMINISTRATION DATA

G.1. PROJECT OFFICER/CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)

The Government's Project Officer/COTR is:

To be identified in the contract

The Project Officer/COTR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

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

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

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

To be identified in the contract

G.4. INVOICE SUBMISSIONS

1) The Contractor shall submit an original and one electronic copy of monthly contract invoices/financial reports to the address shown below:

DHHS/OS/ASPR/AMCG

Attn: Contracting Officer 330 Independence Ave., S.W.

Room G640 Washington, D.C. 20201

2) Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for invoices set forth in Section J entitled “Billing Instructions for Fixed-Price Type Task Orders” and Billing Instructions for Time-and-Materials Task Orders.”

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

G. 5. POST AWARD EVALUATION OF PAST PERFORMANCE

Interim and final evaluations of contractor performance shall be conducted on this contract in accordance with FAR 42.15. The final performance evaluation shall be completed at the time of completion of work. Interim and final evaluations will be submitted to the Contractor as soon as practicable. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement.

RFP No. 10-100-SOL-00001 Page 13

G.6. GOVERNMENT PROPERTY

1) If performance of a contract awarded in response to this RFP, or the pre-award negotiation process, results in the acquisition or use of Government Furnished Property (other than real property), the contract will incorporate the HHS Publication, “Contractor’s Guide for Control of Government Property.” This document can be accessed at:

https://www.knownet.hhs.gov/log/AgncyPolicy/HHSLogPolicy/contractorguide.htm .

RFP No. 10-100-SOL-00001 Page 14

SECTION H--SPECIAL CONTRACT REQUIREMENTS

H.1. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

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

H.2. LABORATORY LICENSE REQUIREMENTS (May 1998)

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.

(End of Clause)

H.3. DISSEMINATION OF INFORMATION (May 1998)

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the Project Officer.

(End of Clause)

H.4. IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The data will be specifically identified in a task order. The contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

H.5. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

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.6. POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

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.

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 the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection Services (APHIS), U.S. Department of Agriculture (USDA), RFP No. 10-100-SOL-00001 Page 15 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.

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 provide the names of all individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents under the contract.

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.7. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in Section I, Paragraph I.2., the contract‘s period of performance is three years. Pursuant to clause 52.217-9 set forth in Section I of this contract, under I.2., the Government may, by unilateral contract modification, extend the term of this contract. The contract’s period of performance may be extended by one year for each option. The total duration of this contract, including the exercise of any options shall not exceed five (5) years. If the Government exercises an option, notice must be given at least 60 days prior to the expiration date of this contract.

H.8. PRESS RELEASES

(a) The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

(b)The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases.

Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Project Officer has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release.

H.9. PUBLICATION AND PUBLICITY

In addition to the requirements set forth in HHSAR Clause 352.270-6, Publications and Publicity incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge the support of the Department of Health and Human Service, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

"This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract (to be determined).

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted for BARDA Project Officer review no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication. Contract support shall be acknowledged in all such publications. A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information.

RFP No. 10-100-SOL-00001 Page 16

H. 10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in DHHS funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov.

Office of Inspector General Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, DC 20026

H.11. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

(1) The Small Business Subcontracting Plan, dated (to be determined) is attached hereto and made a part of the contract.

(2) The failure of any contractor or subcontractor to comply in good faith with FAR Clause 52.219-8 entitled “Utilization of Small Business Concerns” incorporated into this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and is subject to the remedies reserved by the Government under FAR clause 52.219-16 entitled “Liquidated Damages - Subcontracting Plan.”

b. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov .

1. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included as a contact for notification purposes at the following e-mail address: (to be determined)

RFP No. 10-100-SOL-00001 Page 17

PART II – CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

This solicitation incorporates the following clauses by reference, with the same force and effect as if they were given in full text.

The full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/far/index.html and http://www.hhs.gov/oamp/policies/

I.1. GENERAL CLAUSES FOR BOTH A NEGOTIATED FIRM FIXED PRICE SERVICE CONTRACT AND A TIME-

AND-MATERIALS CONTRACT

(1) FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR

CLAUSE NO.

DATE

TITLE

52.202-1 Jul 2004 Definitions

52.203-3 Apr 1984 Gratuities (Over $100,000)

52.203-5 Apr 1984 Covenant Against Contingent Fees (Over $100,000)

52.203-6 Sep 2006 Restrictions on Subcontractor Sales to the Government (Over $100,000)

52.203-7 Jul 1995 Anti-Kickback Procedures (Over $100,000)

52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)

52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)

52.203-12 Sep 2007 Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)

52.203-13 DEC 2008 Contractor Code of Business Ethics and Conduct

52.203-14 DEC 2007 Display of Hotline Poster(s)

52.204-4 Aug 2000 Printed or Copied Double-Sided on Recycled Paper (Over $100,000)

52.204-7 Apr 2008 Central Contractor Registration

52.209-6 Sep 2006 Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000)

52.215-2 Mar 2009 Audit and Records - Negotiation (Over $100,000)

52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format

52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data

52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $500,000)

52.215-15 Oct 2004 Pension Adjustments and Asset Reversions

52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

52.215-19 Oct 1997 Notification of Ownership Changes

52.215-21 Oct 1997 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data – Modifications

RFP No. 10-100-SOL-00001 Page 18

52.219-8 May 2004 Utilization of Small Business Concerns (Over $100,000)

52.219-9 Apr 2008 Small Business Subcontracting Plan (Over $500,000)

52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $500,000)

52.222-20 Dec 1996 Walsh-Healey Public Contracts Act

52.222-21 Feb 1999 Prohibition of Segregated Facilities

52.222-26 Mar 2007 Equal Opportunity

52.222-35 Sep 2006 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities

52.222-37 Sep 2006 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

52.222-50 Feb 2009 Combating Trafficking in Persons

52.222-54 Jan 2009 Employment Eligibility Verification

52.223-6 May 2001 Drug-Free Workplace

52.223-14 Aug 2003 Toxic Chemical Release Reporting (Over $100,000)

52.225-1 Feb 2009 Buy American Act - Supplies

52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases

52.227-1 Dec 2007 Authorization and Consent

52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)

52.229-3 Apr 2003 Federal, State and Local Taxes (over $100,000)

52.232-8 Feb 2002 Discounts for Prompt Payment

52.232-9 Apr 1984 Limitation on Withholding of Payments

52.232-17 Oct 2008 Interest (Over $100,000)

52.232-23 Jan 1986 Assignment of Claims

52.232-25 Oct 2008 Prompt Payment, Alternate I

52.232-33 Oct 2003 Payment by Electronic Funds Transfer--Central Contractor Registration

52.233-1 Jul 2002 Disputes

52.233-3 Aug 1996 Protest After Award

52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim

52.242-1 Apr 1984 Notice of Intent to Disallow Costs

52.242-13 Jul 1995 Bankruptcy (Over $100,000)

52.244-2 Jun 2007 Subcontracts (Over $100,000) *If written consent to subcontract is required, the identified subcontracts are listed in Section B, Paragraph B.4., Advance Understandings.

RFP No. 10-100-SOL-00001 Page 19

52.244-6 Dec 2009 Subcontracts for Commercial Items

52.245-1 June 2007 Government Property

52.245-9 Jun 2007 Use and Charges

52.249-6 May 2004 Termination (Cost-Reimbursement), Alternate IV (Sep 1996)

52.253-1 Jan 1991 Computer Generated Forms

(2) DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER

3) CLAUSES:

HHSAR

CLAUSE NO.

DATE

TITLE

352.202-1 Jan 2006 Definitions - with Alternate paragraph (h) (Jan 2001)

352.228-7 Dec 1991 Insurance - Liability to Third Persons

352.232-9 Jan 2006 Withholding of Contract Payments

352.233-70 Jan 2006 Litigation and Claims

352.242-71 Apr 1984 Final Decisions on Audit Findings

352.270-4 Jan 2001 Pricing of Adjustments

352.270-5 Jan 2006 Key Personnel

352.270-6 Jan 2006 Publications and Publicity

352.270-10 Jan 2006 Anti-Lobbying

[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT].

I.2. SPECIFIC CLAUSES FOR A FIRM FIXED PRICE SERVICE CONTRACT OR A TIME-AND-MATERIALS

CONTRACT

A. Clauses for a Firm Fixed Price Service contract -

(1) 52.243-1, Changes-Fixed Price, Alternate I (APR 1984)

(2) 52.249-4, Termination for Convenience of the Government (Services) (Short Form)

B. Clauses for a Time-and-Material contract –

(1) 52.216-29, Time-and-Materials/Labor-Hour Proposal Requirements (FEB 2007)

(2) 52.232-7, Payments under Time-and-Materials and Labor-Hour Contracts (FEB 2007)

(3) 52.243-3, Changes - Time-and-Materials and Labor-Hours (Sep 2000)

(4) 52.249-14, Excusable Delays (APR 1984)

I.3. ADDITIONAL CONTRACT CLAUSES

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

(1) 52.217-9, Option to Extend the Term of the Contract (March 2000) “(a) The Government may extend the term of this contract by written notice to the Contractor within 60 days prior…