RFP_AI2008-010-wAttachments.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

NIH-NIAID-

DMID-AI2008-010

3. Issue Date:

March 11, 2008

4. Just in Time:

[X]No

[ ]Yes See Part IV Section L

5. Set Aside:

[X]No

[ ]Yes See Part IV Section L

6. Title : Genomic Sequencing Centers for Infectious Diseases

7. ISSUED BY:

Harry Brubaker, Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive, Room 3214 MSC 7612 Bethesda, Maryland 20892-7612

8. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

9. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4:00 pm local time on July 7, 2008. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

10. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO TWO DIFFERENT LOCATIONS.

THE OFFICIAL POINT OF RECEIPT FOR THE PURPOSE OF DETERMINING TIMELY DELIVERY IS

THE ADDRESS PROVIDED FOR THE OFFICE OF ACQUISITIONS AS STATED IN ATTACHMENT 1,

"PACKAGING AND DELIVERY OF THE PROPOSAL." IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR CLAUSE 352.215-70, ENTITLED, "LATE PROPOSALS, AND REVISIONS" LOCATED IN SECTION L.1. OF

THIS SOLICITATION.

11. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. http:// www.ccr.gov

12. FOR INFORMATION CALL: Harry Brubaker

PHONE: (301) 443-2966

e-MAIL: brubakerh@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Yvette Brown Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases http://www.ccr.gov http://www.ccr.gov

RFP Number : NIH-NIAID-DMID-AI2008-010

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

- 3 -

12. Institutional Responsibility Regarding Conflicting Interests of Investigators

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

15. Prohibition on Contractor Involvement with Terrorist Activities

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

5. Instructions to Offerors Regarding Protection of Human Subjects

6. Required Education in the Protection of Human Research Participants

7. Inclusion of Women and Minorities in Research Involving Human Subjects

8. Inclusion of Children in Research Involving Human Subjects

9. Research Involving Prisoners as Subjects

10. Research Involving Human Fetal Tissue

11. Research Involving Recombinant DNA Molecules (including Human Gene Transfer Research)

12. Human Embryonic Germ Cell (HEGC) Research

13. Human Embryonic Stem Cell (HESC) Research

14. Possession, Use and Transfer of Select Biological Agents or Toxins

15. Obtaining and Disseminating Biomedical Research Resources

16. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Cost and Pricing Data

5. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

6. Salary Rate Limitation in Fiscal Year 2007

7. Small Business Subcontracting Plan

8. HUBZone Small Business Concerns

9. Extent of Small Disadvantaged Business Participation

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Representations and Certifications - SECTION K

16. Travel Costs/Travel Policy

17. Certification of Visas for Non-U.S. Citizens

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. HUMAN SUBJECT EVALUATION

- 4 -

3. EVALUATION OF DATA SHARING PLAN

4. TECHNICAL EVALUATION CRITERIA

5. PAST PERFORMANCE FACTOR

6. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

- 5 -

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objective of the Genomic Sequencing Centers for Infectious Diseases is to provide rapid and cost-efficient production of high-quality genome sequences of microorganisms and invertebrate vectors of infectious diseases and to make the resulting genomic data rapidly and readily accessible to the broader scientific community through publicly accessible international databases. In addition, the Centers shall provide comparative genomics and genotyping to examine genetic variation in populations and communities of human pathogens and also across the human genome to identify genetic associations with observable phenotypes in the pathogen and in the human host.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

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) 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; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

Confidentiality and Material Transfer

It is anticipated that some reagents and data provided to the Center will be proprietary in nature. NIAID's experience has shown that third parties are reluctant to provide their proprietary information or materials without complete assurance that their intellectual property rights are protected. Therefore, the NIAID requires the Contractor, its subcontractors and its collaborators to safeguard the proprietary materials, data and other information of the third party suppliers. The Contractor shall therefore establish Material Transfer Agreements (MTAs) and/or Confidential Disclosure Agreements (CDAs) with third party suppliers, as needed.

Notwithstanding the foregoing, all such MTAs and CDAs will allow the Contractor to deliver materials, data and other deliverables specified under the contract and will not conflict with the contract. If the Contractor is uncertain if terms

- 6 -of an MTA or CDA conflict with the contract, the Contractor shall consult with the Contracting Officer. The Contractor shall submit copies to the Project Officer and Contracting Officer of any MTAs and CDAs that the Contractor or its subcontractors and the third party have agreed upon.

In addition, the Contractor shall ensure that all deliverables under the contract are delivered without any encumbrances. Furthermore, the Contractor shall acquire any and all necessary proprietary rights, consents and/or releases from its subcontractors, its collaborators and/or third parties to permit the public dissemination and/or sharing of data, protocols, technologies, materials, reagents, bioinformatics and computational software tools, source codes and other resources, and to fulfill all other requirements of the contract.

Data Usage and Confidential Information

The Contractor agrees that the use of data and information generated by the Contractor, as well as those provided to the Contractor by third parties or by the Government for activities performed under this contract, shall be restricted to projects within the scope of the contract and shall not be released (except by the publication provisions of this contract) to any other party without approval of the Project Officer. This restriction applies until the data and information are publicly released to the scientific community in accordance with the publication provisions of this contract.

The Contractor agrees that manuscripts/abstracts containing data/information generated under this contract by the Contractor, or containing third party data already published or otherwise publicly available, will not be submitted for publication until Project Officer has reviewed and commented upon the manuscript/abstract. The Contractor will submit for review and comment a copy of any manuscript or abstract based only on data/information generated by Contractor, or containing third party data already published or otherwise publicly available no later than 30 calendar days prior to the submission to the journal or conference organization. The Project Officer will review the submitted documents in a period of time not to exceed 15 calendar days from receipt and shall only be able to make recommended changes, which Contractor will incorporate if reasonable.

The Contractor agrees that manuscripts/abstracts containing unpublished or not otherwise publicly available data/ information generated or provided to the Contractor by third parties under this contract will not be submitted for publication until Project Officer clearance has been received in writing. For all manuscripts/documents containing unpublished or not otherwise publicly available data/information generated or provided to the Contractor by third parties, the Contractor shall submit for review, comments and approval, a copy of any manuscript or abstract no later than 30 calendar days prior to the submission to the journal or conference organization. In addition, the Contractor shall provide the Project Officer with evidence (i.e. email exchanges, manuscript authors list, collaboration letter) that the third party supplier of the data/information is aware of the Contractor's intention to publish and has approved

it. The Project Officer will review the submitted documents in a period of time not to exceed 15 calendar days from receipt and will either grant approval in writing and/or make recommended changes, which the Contractor will incorporate if reasonable.

A publication is defined as an issue of printed material offered for distribution or any communication or oral presentation of information.

Review of Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. In accordance with NIH Manual Chapter 1754, misrepresenting contract results or releasing information that is injurious to the integrity of NIH may be construed as improper conduct. The complete text of NIH Manual Chapter 1754 can be found at: http://www1.od.nih.gov/oma/manualchapters/management/1754/. 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 fourteen (14) calendar days prior to the issuance of the press release.

Confidential Treatment of Government Sensitive/Proprietary Information

If the Government determines that some information/data that the Contractor will be provided by the Government or a third party during performance of the contract may be of a sensitive/proprietary nature, the Contractor shall guarantee strict confidentiality of the information/data that is provided by the Government during the performance of the contract.

Similarly, if the Government determines that data/information generated under the contract at the Government's request is deemed to be sensitive/proprietary, the Contractor shall guarantee strict confidentiality of the information/

- 7 -data during the performance of the contract. The rights and obligations of the parties with respect to such information shall be governed by the following terms:

Sensitive/Proprietary Information refers to data/information of any kind which is disclosed by the Government or a third party to the Contractor, or that is generated at the request of the Government with the consent of the Contractor and deemed by the Government to be "Sensitive/Proprietary Information". Such data shall be treated as "Confidential" and will be identified with the appropriate marking. The Government shall identify, in advance of the initiation of the requested activity, the data types and datasets that would be considered to be Sensitive/Proprietary Information. In the event that sensitive/proprietary information is provided visually or orally, obligations of confidentiality shall attach only to that information which is identified as "Confidential" at the time of disclosure.

Limitations on use

The Contractor shall use the Government's sensitive/proprietary information solely for the purposes of the contract.

It is agreed by the Government and the Contractor that the disclosure of Sensitive/Proprietary Information shall not be construed as granting any right or license with respect to such information except as set forth herein or in a duly executed license agreement.

In order to protect against the inadvertent disclosure of Confidential Information as it is described in FAR Clause 352.224-70 (a) it is understood by both parties the following action will be taken:

(A) The Contractor agrees not to disclose in any publication/presentation any Confidential Information (as defined in 352.224-70 (a)).

(B) All proposed publications by the Contractor and any reports/material/data developed under the contract will be submitted to appropriate academic publications or presented at academic conferences; however, disclosure of Sensitive/Proprietary information or data, in whole or in part, generated by the Contractor at the request of the Government can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

- 8 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated January 31, 2008, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

a. Technical Progress Reports

1. In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES ARTICLE in SECTION F.

The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the Project Officer. These reports shall be brief and factual and prepared in accordance with the format described below.

Format of Cover page: All reports shall include a cover page prepared in accordance with the following format:

• Contract Number and Project Title

• Period of Performance Being Reported

• Contractor's Name and Address

• Author(s)

• Date of Submission

• Delivery Address

Quarterly Report on Total Genomic Sequencing Costs

This report shall include a detailed accounting of the unit cost of genomic sequencing. In this report, define the unit cost of a working draft sequence as measured by cost per lane of sequencing, and take into account all expenses associated with sequencing, beginning with construction of a library through assembly and closure.

Semi-Annual Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The initial report shall be submitted for the first full six months of the contract performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six full calendar months. Specifically, the Semi-Annual Progress Report shall address the following components:

a) An introduction covering the purpose and scope of the contract effort.

b) A detailed description of outreach activities to promote awareness of the genomic sequencing services provided to the broad scientific community.

- 9 -

c) A list of all proposals submitted by the scientific community and the status of their review and approval.

d) A list of all inquiries regarding requests from members of the broad scientific community to work with the Center to develop Project Plans for genomic sequencing research projects to be undertaken by the Center.

e) A detailed description of progress made on the genomic sequencing and genotyping projects being undertaken by the Center.

f) A description of problems encountered, the difference between planned and actual progress, cause(s) of the difference, and proposed or completed corrective actions.

g) A description of materials and reagents generated during the reporting period and a discussion of efforts to make these items available to the scientific community.

h) A description of the activities related to establishment and/or maintenance of the IT infrastructure, data management systems, security systems, public web portal, algorithms and software applications.

i) A summary of all meetings, in person or via teleconference, with the Project Officer, Contracting Officer, and Scientific Working Group (SWG).

j) Updates to all ongoing and approved Project Plans.

k) A description of progress on administration and management issues (e.g., establishment of subcontracts), including problems encountered, and proposed or completed corrective actions.

l) Disclosure of all patents and copyrights or patent and copyright applications filed in or outside the United States by the Contractor, subcontractor and collaborators for activities derived from, or established by work supported by the contract.

m) Copies of preprints and reprints of papers, abstracts, book chapters and any other type of publication not provided in final form during the previous reporting period.

n) A work plan including, timeline and description of the work proposed for the next 6 month reporting period.

o) An updated list (recommended 2 pages) of all the Contractor's staff members, including those at subcontract locations and consultants, and a 2-3 paragraph description of each individual's roles in ongoing projects and their percent effort committed to the project and discussion about any personnel issues that seriously impair the Centers' activities.

p) A detailed account of the financial status of the contract. This shall include cumulative spending for each project as well as a breakdown of expenditures for each project, including:

personnel (number of hours expended for each project and cumulative overall), fringe benefits, consultants (identify specific role), materials and supplies, equipment (specify), staff travel (identify project and purpose of travel), and other direct costs.

q) An inventory of facilities maintenance, supplies, equipment, materials and reagents.

Document efforts to maintain a state-of-the-art facility.

r) Other pertinent contract information as requested by the Project Officer or the Contracting Officer.

Annual Progress Report

This report includes a summation of the results of the entire contract work for the period covered. An Annual Progress Report shall not be required for the period when the Final Report is due. This report shall also include all of the sections provided in the Semi-Annual Progress Report, an additional section to summarize all work conducted during the reporting period, and a section to address the anticipated work plan and budget in total costs for the coming year. A Semi-Annual Progress Report shall not be submitted when an Annual Progress Report is due.

Draft Final Report

The Contractor shall provide the Project Officer and Contracting Officer with 3 copies of the Final Report in draft form in accordance with the DELIVERIES Article in SECTION F of this contract 120 calendar days prior to the completion date of this contract. The Project Officer will review the Draft Final Report and provide the Contractor with comments within 15 calendar days after receipt. The Draft Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified below.

- 10 -

Final Report

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract. An Annual Progress Report shall not be required for the period when the Final Report is due.

2. Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

b. Other Reports/Deliverables

1. Source Code and Object Code

In addition to the above reports, the following are considered other reports and deliverables under this contract. A listing is included in the DELIVERIES Article in SECTION F.

• Human Subjects IRB Annual Report (Form OMB No. 0990-0263-formerly Optional Form 310)

• Invention Report Requirement

• Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040-A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions 6700-B Rockledge Drive MSC 7612, Room 3214 Bethesda, Maryland 20892- 7612

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as

- 11 -it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

ARTICLE D.1. PACKAGING

As required packages shall be in a temperature controlled enviroment.

ARTICLE D.2. MARKING

All Hazardous Materials shall be marked appropriately for shipping.

ARTICLE D.3. SHIPPING

Genomes that will be sequenced through these Centers include microorganisms considered agents of bioterrorism (NIAID Category A-C priority pathogens http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/ CatA.htm), clinical isolates, closely related species and strains, invertebrate vectors of diseases, and microorganisms responsible for emerging and re-emerging infectious diseases (http://www3.niaid.nih.gov/research/topics/emerging/ list.htm). Shipping of select agents shall be in accordance with the DHHS regulations regarding the transfer of select agents (42CFR part 7s; http://www.cdc.gov/od/ohs/biosfty/shipregs.htm) and shipping cGMP product and cell banks shall be in accordance with cGMP guidelines (as defined in the U.S. code of Federal Regulations -21CFR 211).

• Temperature controlled enviroment is required.

• Shipments will be time sensitive/time critical.

• International shipping will apply.

• Shipping insurance is required.

• Hazardous Materials shipping is applicable.

• Other specific shipping requirements will be listed as necessary.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the NIAID Project Officer is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at: 6610 Rockledge Drive; Bethesda, MD 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

http://www.iedison.gov

- 12 -

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract.

will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below.

a. Technical Progress Reports

Item Type of Report Initial Report Due Recipient Subsequent Reports Due

1. Quarterly Report on Genomic Sequencing Costs

The report is due 45 days after the date of contract award.

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Each report is due on or before the 15th of each month following each reporting period.

2. Semi-Annual Progress Report

15th of the month following the first reporting period consisting of the first full 6 months of performance plus any fractional part of the initial month

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Semiannually; due on the 15th of the month following the end of each 6-month period beginning with the start of the contract.

A Semi-Annual Progress Report will not be due when an Annual Progress Report or Final Report is due.

3. Annual Progress Report

Within 30 calendar days after the anniversary date of contract

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Annually; submitted within 30 calendar days after the anniversary date of the contract. An Annual Progress Report is not due when a Final Report is due.

4. Draft Final Report 120 calendar days prior to the expiration date of contract

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

5. Final Report Within 60 calendar days of the expiration date of the contract

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

6. Summary of Salient Results

Within 60 calendar days of the expiration date of the contract

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

7. Human Subjects IRB Annual Review Report

With Annual/Final Reports PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Annually; submitted 30 days after the anniversary date.

8. Invention Report As required PO and CO should each receive 1 hard

As required

- 13 -copy and 1 electronic copy of each report

9. Ad Hoc Reports As requested PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

10. Draft Initial Transition Plan

Within 15 calendar days of contract award

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

11. Final Initial Transition Plan

Within 5 calendar days of receipt and agreement on PO comments

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

12. Initial Transition Report

Within 120 calendar days of contract award

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

13. Draft Final Transition Plan

12 months prior to the completion date of the contract

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

14. Final Transition Plan

6 months prior to the completion date of the contract

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

N/A

If the Contractor becomes unable to deliver the reports specified above within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance off the work, the Contractor shall provide the Contracting Officer with immediate written notice of anticipated delay, the reason for the delay, and the expected date of delivery for the report. The Contracting Officer will review the Contractor's notice of anticipated delay and within seven (7) calendar days will instruct the Contractor of the necessary action to be taken.

b. Other Reports and Deliverables (Delivery Schedule)

Item Deliverable SOW Reference

Delivery Schedule Recipient Subsequent Deliverables Due

1. Plan for Genomic Sequencing and Genotyping Services to the Scientific Community

Item 4.B. Within 30 calendar days of contract award

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Revised Plan due within 14 calendar days of receipt of and agreement on PO comments

2. Project Plans for Approved Genomic Sequencing and Genotyping Proposals

Item 3.D. Within 30 calendar days of notification of proposal approval

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Revised Plan due within 14 calendar days of receipt of and agreement on PO comments. Thereafter, update Project Plans on a semi-annual basis as part of the Semi-Annual Progress Report

3. Agenda, meeting materials and summaries for SWG meetings

Item 5.D. Agenda and meeting materials due 30 calendar days prior to meeting; summaries

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

- 14 -due within 7 calendar days of meeting

4. Draft Quality Assurance/Quality Control Plan

Item 7.A.2) Within 14 calendar days of contract award

PO and CO should each receive 1 hard

5. Final Quality Assurance/Quality Control Plan

Item 7.A.2) Within 10 calendar days following receipt of PO comments on draft plan.

PO and CO should each receive 1 hard

6. System Security Plan Item 8.D. Within 90 calendar days of contract award

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Updated SSP required as part of the Annual Progress Report

7. Plan to Share Research Data, Reagents and Resources with the Scientific Community

Item 9.A. Within 30 calendar days of contract award; provide a revised version within 10 calendar days after receipt of and agreement on PO comments

PO and CO should each receive 1 hard copy and 1 electronic copy of each report

Annually as part of the Annual Progress Report

8. Deposit study-generated materials and reagents into public repositories

Item 9.A.6).c)

Within 60 calendar days of conclusion of study

PO and CO should each receive 1 hard

9. Public web portal Item 9.B. Within 90 calendar days of contract award

PO and CO should each receive 1 hard

10. Agenda, meeting materials and summaries of Monthly meetings/ teleconferences

Item 11.B.2) Agenda and meeting materials due 5 calendar days prior to the meeting;

summaries due within 7 calendar days of conclusion of the meeting or teleconference

PO and CO should each receive 1 hard

11. Annual Site Visit Report

Item 11.B.3).a)

Within 30 calendar days of the site visit

PO and CO should each receive 1 hard

12. Agenda, meeting materials and summaries for Annual Programmatic Meetings

Item 11.B.3).b)

Agenda and meeting materials due 14 calendar days prior to meeting; summaries due within 7 calendar days of conclusion of the meeting

PO and CO should each receive 1 hard

- 15 -

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this contract:

" To be provided in resultant contract"

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

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Project Officer designation.

ARTICLE 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:

Name Title

"To be specified prior to award" http://www.acquisition.gov/comp/far/index.html

- 16 -

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Payment requests shall be submitted as follows:

a. One original to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy to the following approving official:

Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases, NIH Room 3214 6700-B Rockledge Drive MSC 7612

BETHESDA, MD 20892- 7612

E-Mail: NIAIDOAInvoices@niaid.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official in lieu of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in a format compatible with the computer systems at NIH [e.g., MS Word, MS Excel, or Adobe Portable Document Format (PDF). [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR Subpart 32.9 for a proper invoice, the Contractor shall include the following information on all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Institute of Allergy and Infectious Diseases.

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAID OA Invoices.

c. Vendor Identification Number. This is the 7 digit number that appears after the Contractor's name in Block 7 of Standard Form 26. [Note: This only applies to new contracts awarded on/ after June 4, 2007, and any existing contract modified to include the number.]

d. DUNS number or DUNS+4 that identifies the Contractor's name and address exactly as stated on the face page of the contract.

e. Identification of whether payment is to be made using a two-way or three-way match. This contract requires a Two-Way match.

- 17 -

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) - 496-6088.

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health 6100 Building, Room 6B05

6100 EXECUTIVE BLVD MSC-7540

BETHESDA MD 20892-7540

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.5. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "Contractor's Guide for Control of Government Property," which can be found at:

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR

42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted "To be provided prior to award."

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm http://oamp.od.nih.gov/OD/CPS/cps.asp

- 18 -

ARTICLE H.1. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this contract until the protocol is developed and approved by NIAID, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer a properly completed "Protection of Human Subjects Assurance Identification/ IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor's self designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310).

When research involving Human Subjects will take place at collaborating sites or other performance sites, the Contractor shall obtain, and keep on file, a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the research.

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH

PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.3. HUMAN MATERIALS

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

ARTICLE H.4. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

- 19 -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.