RFP.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

N02CO07013-64

3. Issue Date:

05/04/2010

4. Set Aside:

[X] No

[ ] Yes Part IV Section L

5. Title : RECOVERY - Biospecimen Core Resources (BCR) Providing Biospecimen Processing Services for The Cancer Genome Atlas (TCGA)

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health Treatment and Support Branch P.O. Box B 244 Miller Drive, Room 101 Fort Detrick Frederick, MD 21702-1201

7. SUBMIT OFFERS TO:

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

8. 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 2:00PM Eastern Prevailing Time on June 4, 2010. 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.

9. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO THE OFFICIAL POINT OF RECEIPT FOR

THE PURPOSE OF DETERMINING TIMELY DELIVERY 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, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH SUBPARAGRAPH (c)(3) OF FAR CLAUSE 52.215-1, ENTITLED, "INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION" LOCATED IN SECTION L.1.

OF THIS SOLICITATION.

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

11. FOR INFORMATION CALL: James D. Carder

PHONE: (301)228-4221

e-MAIL: carderj@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

See Section L. for instructions on submitting questions in response to this solicitation. Robin M. Irving

Contracting Officer Office of Acquisitions National Cancer Institute http://www.ccr.gov http://www.ccr.gov

RFP Number : N02CO07013-64

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

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. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

i. AVAILABILITY OF THE "FEDERAL ADP AND TELECOMMUNICATIONS STANDARDS INDEX."

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

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12. ROTC Access and Federal Military Recruiting on Campus

13. Past Performance Information

14. 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. Obtaining and Disseminating Biomedical Research Resources

15. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

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

4. Small Business Subcontracting Plan

5. HUBZone Small Business Concerns

6. Extent of Small Disadvantaged Business Participation

7. Total Compensation Plan

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

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

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. HUMAN SUBJECT EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION CRITERIA

5. PAST PERFORMANCE FACTOR

6. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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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.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Establish a Biospecimen Core Resource(s) (BCRs) site for receiving tissue and data from the multiple the Tissue Source Site (TSS) networks for storage, quality control, processing into molecular analytes, shipping of high quality analytes to genome characterization and sequencing centers, and other support efforts for to The Cancer Genome Atlas (TCGA) Program.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

a. The estimated cost of the Base Period of this contract is $ . {The final contract will contain the cost provisions agreed upon by the Government and the Offeror.}

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ . {The final contract will contain the cost provisions agreed upon by the Government and the Offeror.}

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period - Outreach (18 months) ARRA Funding

Option Periods:

Option Period 1- 12 months) Appropriated funds

Option Period 2 - (12 months) Appropriated funds

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 3 - (12 months) Appropriated funds

Option Period 4 - (6 months) Appropriated funds

Total [Base Period and Options]

e. Total funds currently available for payment and allotted to this contract are $ of which $ represents the estimated costs, and of which $ represents the fixed fee. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

f. It is estimated that the amount currently allotted will cover performance of the contract through .

g. The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor.

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.

1. Compatiblity

All work performed at one Biospecimen Core Resource (BCR) must be compatible with the second BCR by using the same clinical data collection and aggregation tools and the same Laboratory Information Management System (LIMS).

Also, the data collected by the BCRs must be compatible with the format of the TCGA Data Coordinating Center tools and those developed during the course of the project by Genome Data Analysis Centers.

2. Software

As outlined in the Statement of Work, all software developed under this contract shall be released under an open-source license that complies with caBIG licensing guidelines (https://cabig.nci.nih.gov/working_groups/DSIC_SLWG/ index_html/document_view).

3. Confidential Treatment of Sensitive Information:

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Governmentduring the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractorreceives 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.

4. TCGA Intellectual Property Policy

In accordance with FAR 52.227-14, incorporated herein by reference, the government retains rights to all data produced under this contract including, but not limited to, SOPs, reports, data standards, and software.

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Specifically, the following is the TCGA Intellectual Property Policy and should be adhered to for this acquisition.

The goal of the TCGA Intellectual Property policy is to maximize the benefit of all research funded as part of the TCGA program for the improvement of public health through discoveries of the scientific community. TCGA Data Sharing and Data Release policies provide for a broad freedom-to-operate for all users of TCGA data by rapidly placing all data in the public domain. The TCGA Intellectual Property policy is intended to ensure that these data are unencumbered by intellectual property claims. In addition to data, computer algorithms produced specifically to analyze TCGA data, software source code or other resources made possible under the auspices of TCGA will be made available to the public domain without intellectual property restrictions.

It is expected that any data producer in the TCGA research network (whether supported by a grant or contract mechanism) will make all information available, without requirement for licensing, for applications such as, but not necessarily limited to, the use of markers in developing assays or targets for therapeutics and diagnostics. All TCGA research network members and affiliated institutions must acknowledge agreement to the TCGA Intellectual Property Policy and affirm that they will not make no intellectual property claim derived from primary data produced as a member of the network.

TCGA encourages broad use of all data coupled with a responsible approach to management of intellectual property derived from downstream discoveries that are consistent both with the recommendations cited in NIH's Best Practices for the Licensing of Genomic Inventions and the NIH Research Tools Policy. The filing of patent applications in a manner that would restrict use of TCGA data, software and other resources could substantially diminish the value and public benefit provided by this program. Investigators and their institutions approved for use of controlled-access data sets agree to abide by this policy as specified in the terms and conditions of the TCGA Data Use Certification.

5. American Recovery and Reinvestment Act (ARRA) Funds

The base period of this contract will be funded by American Recovery and Reinvestment Act (ARRA) funds. The Government's obligation under this contract is for the initial base period. Funding for the option years is subject to the availability of appropriated funds and programmatic relevance/balance/need.

6. Production/Workload Assignments:

As outlined in the Statement of Work the Contractor shall receive tissues and clinical data from the TSS sites for processing according to direction from the NCI Contracting Officer Technical Representative (COTR). Work will be assigned to each BCR according to tumor type and balanced with program milestones and priority. Work may be assigned or reassigned as needed to accommodate and maintain the flow, quantity and quality of products through the pipeline, ensure optimal molecular analyte quality, and optimization of data accrual and sharing as outlined in the Statement of Work.

7. Contract Number Designation:

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the two contract numbers that appear on the face page of the contract as follows:

Contract No. TBD [insert the 17 digit number that appears in Block 2 of the SF-26, i.e. HHSN26120041234C.]

NCI Control No. TBD [insert the 17 digit number that appears in the upper left hand corner of the SF-26, i.e. N01-

CO-2004-00034.]

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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 March 3, 2010, 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 the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) one (1) hard copies of these reports will be required as follows:

[X] Monthly [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

b. Other Reports/Deliverables

Reporting requirements in this section of the documents do not de-obligate the BCR from any reporting, data exposure and data transmission requirements also enumerated in the Statement of Work.

In addition to reports required by other terms of this contract, the Contractor shall prepare and submit the following reports:

Working Reports:

The following reports are considered time sensitive:

1. Standard Operating Protocols - (see SOW for additional information Section 7)

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The Contractor (BCR) shall provide copies of SOPs directly to the NCI COTR and updates/changes made to SOPs shall be provided within thirty (30) calendar days of implementation. All SOPs should be maintained on the TCGA Sharepoint drive using the established protocol.

2. Software Development Artifacts

All software development artifacts, information about configuration, and source code shall be submitted, and kept up to date, on the designated TCGA BCR informatics sites: the NCI Wiki and shared source code repository.

3. Reports associated with Individual TSS

1) If a TSS requires a training visit for shipping purposes, the BCR leading that training shall submit a report summarizing the information shared during the visit to the NCI COTR within five (5) business days of return travel.

2) A copy of a specific TSS's MTA shall be provided to the NCI COTR directly or through the document sharing system (e.g. Sharepoint) provided to the contractor.

3) A copy of the IRB documentation or the equivalent from an individual TSS's participation in this project shall be provided to the NCI COTR directly or through the document sharing system (e.g.

SharePoint) provided to the contractor.

4) Reports of estimated TSS case and sample inventory, and reports of planned shipments from TSS inventory to BCR, shall be provided to NCI COTR. Reports shall be submitted as part of the regular Progress Report, required below. Summaries on a per shipment basis shall be provided using a common tracking mechanism approved of by the NCI COTR (e.g. using a shared spreadsheet).

4. Reports associated with individual Centers

Electronic copies of reports on the following activities associated with individual Genome Characterization Centers and Genome Sequencing Centers shall be delivered to the NCI COTR as applicable:

1) Reports, at summary and individual analyte aliquot level, of shipments to Centers. Reports shall specifically enumerate re- shipment of analytes.

2) Reports shall enumerated any deviations from shipment plans, and any problems having arisen, including descriptions of problems with analytes reported back from Centers to the BCR.

3) Enumeration of administrative documents in progress and executed between BCR and Centers, including, if applicable, MTA, Data Use Agreements, and provision of TSS IRB documentation.

5. Reports associated with the Data Coordinating Center (DCC)

Electronic copies of reports on the following activities associated with individual the Data Coordinating Center shall be delivered to the NCI COTR as applicable:

1) Reports on planned data upload format changes, including listing of dates of notification and date of implementation of data format change plans.

2) Reports on upload of BCR data files to DCC, including date, batch ID, and revision level.

3) Reports on any data upload failures.

6. Weekly Status Reports (due electronically 3PM Eastern Prevailing Time (EPT) the day before the weekly status conference call)

1) Each BCR shall participate in a weekly (or more frequently as needed) teleconference with the NCI COTR. The meeting will review the weekly written status report from the BCR that shall include the following information:

a. Progress on receipt of MTA and IRB documentation from new TSSs

b. Number of samples, tumor types, source of normal, name of TSS and other pertinent information for each case coming through the BCR during the past week.

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c. Number of samples at each stage of the BCR pipeline (in the door, pathology QC, molecular analyte extraction, analyte distribution, etc.)

d. Deviations from the SOW or any SOP should also be reported in the weekly report.

e. Reports on clinical data completion and accuracy rates, segmented by each TSS and by each batch of analytes distributed to Centers.

f. Indentification of all issues/problems/delays encountered and resolution/status of each issue.

g. Other elements as required by the NCI-COTR

7. Ad-Hoc Reports

The BCR shall provide reports to the NCI-COTR providing answers to specific queries regarding any aspect of the BCR's supply chain logistics pipeline/sample status no more than five (5) business days after a request is made.

8. Monthly Progress Report

The contractor shall submit a monthly report that shall include, at minimum, that details the information provided in the weekly reports as well as how the BCR deviated or met the expectations established by the SOW. This report shall also detail the status of the BCR's own IRB protocol/approval for their work for TCGA. Further this report shall provide a status of problems incurred and resolution of problems during the reporting period. In addition to a summary of the previous dashboard (weekly reports) from the past month, the monthly report should include any other activities not reported on in the dashboard including, but not limited to: training visits performed, training visit reports, MTAs and IRB approvals received, clinical data form development/edits, document deposition into the shared depository (Sharepoint), etc. The monthly report should clearly delineate/map to the invoice received so that all work on the invoice is documented and described in detail. Due ten (10) calendar days after the end of each month. A monthly progress report shall not be submitted when the final report is due.

American Recovery and Reinvestment Act - Reporting Requirements

9. ARRA Report

This contract requires the Contractor to provide products and/or services that are funded by the American Recovery and Reinvestment Act of 2009 (Recovery Act). Section 1512(c) of the Recovery Act requires the contractor to report on its use of Recovery Act funds under this contract.

The Contractor shall report the information required by FAR 52.204-11(d), which is incorporated into Article I.4. of this contract, using the online reporting tool available at http://www.FederalReporting.gov.

All work funded, in whole or in part, by the Recovery Act, and for which an invoice is submitted prior to September 30, 2009, shall be reported cumulatively and submitted on October 10, 2009. After September 30, 2009, reports are due no later than the 10th day after the end of each calendar quarter.

These reports will be made available to the public.

In addition, the Contractor shall submit a courtesy copy of each report to the Contracting Officer and Contracting Officer's Technical Representative (COTR).

Final reporting:

10. Source Code/Object Code/Software Documentation and Software User Manuals

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.

Additionally, provide software documentation and user manuals.

11. Final Report

The Contractor shall provide a final report shall that details the work performed and results obtained for the entire contract period of performance. This report is due on the expiration date of the contract.

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Information Security Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

12. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. (Reference subparagraph c. (2) of the INFORMATION SECURITY Article in SECTION H of this contract.)

13. Information Security Training Report

The Contractor shall maintain a listing by name and title of each employee (including subcontractors) working under this contract that has completed the NIH required information security training. Any additional security training completed by Contractor/Subcontractor staff shall be included on this listing.

The listing of completed training shall be submitted prior to performing any contract work. Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.] (Reference subparagraph d. of the INFORMATION SECURITY Article in SECTION H of this contract.)

14. Contractor Notification of New and Departing Employees Report

The Contractor shall notify the Contracting Officer's Technical Representative (COTR) and Contracting Officer within five business days of staffing changes for positions that require suitability determinations as follows (Reference subparagraph f. of the INFORMATION SECURITY Article in SECTION H of this contract.):

(1) New Employees: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

(2) Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COTR and/or Contracting Officer upon request

15. Contractor - Employee Non-Disclosure Agreements

The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/ security/Nondisclosure.pdf . (Reference subparagraph g. of the INFORMATION SECURITY Article in SECTION H of this contract.)

16. Self Assessment, Information Security Plan Reporting and Common Security Configurations Reporting

(1) NIST SP 800-53 Self-Assessment (Reference subparagraph h. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The contractor shall annually update and resubmit its Self-Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information Systems to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer no later than the completion date of the period of performance. http://csrc.nist.gov/publications - under Special Publications).

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The Contractor's annual update to its Self-Assessment Questionnaire shall include similar information for any subcontractor that performs under the SOW to (1) develop a Federal information system(s) at the Contractor's/Subcontractor's facility, or (2) host and/or maintain a Federal information system(s) at the Contractor's/Subcontractor's facility.

(2) Information System Security Plan (Reference subparagraph i. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The Contractor's draft ISSP submitted with its proposal shall be finalized in coordination with the COTR no later than 90 calendar days after contract award.

Following approval of its draft ISSP, the Contractor shall update and resubmit its ISSP to the COTR every three years or when a major modification has been made to its internal system. The Contractor shall use the current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing Security Plans for Federal Information Systems. ( http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf ).

The Contractor shall include similar information for any subcontractor performing under the SOW with the Contractor whenever the submission of an ISSP is required.

(3) The Contractor shall ensure that any information technology acquired under this contract incorporates the applicable common security configuration established at the National Institutes of Standards and Technology (NIST) at http://checklists.nist.gov

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 Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, 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 Cancer Institute Office of Acquisition PO Box Box B, 244 Miller Drive Fort Detrick, Room 112 Frederick, Maryland 21702- 1201

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

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

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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.

Please see the Statement of Work (SOW) for shipping requirements for this contract.

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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, Contracting Officer's Technical Representative (COTR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute Bethesda, MD

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

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

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from August 15, 2010 through February 14, 2012.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Option Period One (1)

February 15, 2012 - February 14, 2013

Option Period Two (2)

February 15, 2013 - February 14, 2014 Option Period Three(3) February 15, 2014 - February 14, 2015 Option Period Four (4) February 15, 2015 - August 14, 2016

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery

(1) Standard Operating Protocols One (1) hard copy and one

(1) PDF format to COTR Due Date: Within thirty (30) calendar days after implementation

(2) Software Development Artifacts One (1) hard copy and one

(1) PDF format to COTR

Due Date: As requested by COTR.

(3) Reports associated with Individual

TSS

One (1) hard copy and one

(1) PDF format to COTR

Due Date:

Training Visit - within five (5) business days of travel return

TSS MTA Report(s) - As requested by COTR.

IRB document(s) - As requested by COTR.

TSA Case/Sample/Shipping - Regular Report

(4) Reports associated with Individual Centers

One (1) hard copy and one

(1) PDF format to COTR

Due Date: As requested by COTR in accordance with SOW and Article C. 2.

(5) Reports associated with Data

Coordinating Center (DCC) One (1) hard copy and one

(1) PDF format to COTR

Due Date: As requested by COTR in accordance with SOW and Article C. 2.

(6) Weekly Status Reports

One (1) PDF format to

COTR

Due Date: At 3:00PM EPT before the weekly status conference call.

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Item Description Quantity Delivery

(7) Ad- Hoc Reports

One (1) hard copy and one

Due Date: No more than five (5) business days after time of request from COTR.

(8) Monthly Progress Report One (1) hard copy and one

One (1) hard copy and one (1) PDF format to the Contracting Officer

Due Date: On or before the Ten

(10) calendar days after the end of each calendar quarter.

(9) Quarterly ARRA Report One (1) hard copy and one

Contracting Officer

Due Date: On or before the Ten

(10) calendar days after the end of each month.

(10) Source Code, Object Code, Software Documentation and Software User Manuals

Contracting Officer

Due Date: On or before the expiration date of the contract.

(11) Final Report One (1) hard copy and one

Contracting Officer

Due Date: On or before the expiration date of the contract.

(12) Roster of Employees Requiring Suitability Investigations (Reference Article C.2.b. 12 and Article H.12.c.2

Contracting Officer

Due Date: Within 14 days of the effective date of the contract.

*Any revisions to the Roster as a result of staffing changes shall be submitted within fifteen (15) calendar days of the change.

(13) Information Security Training Report (Reference Article C.2.b. 13 and Article H.12.d.)

Contracting Officer

Due Date: First report is due prior to performing any contract work. *Revisions to the list due to staffing changes shall be submitted within five (5) calendar days prior to the change.

(14) Contractor Notification of New and Departing Employees Report (Reference Article C.2.b.14 and Article H.12.f.)

Contracting Officer

Due Date:*First report is due on or before October 15, 2010.*Revisions to the list due to staffing changes shall be submitted within five (5) working days prior to the change.

(15) Contractor -Employee Non- Disclosure Agreements (Reference Article C.2.b.15 and Article H.12.g.)

Due Date: *Prior to the start of work under the contract.*Additional Staff must

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Item Description Quantity Delivery One (1) hard copy and one (1) PDF format to the Contracting Officer complete prior to start of work under the contract.

(16) Self Assessment & Information Plan

- NIST SP 800-53 (Reference Article C.2.b. 16 (1) and Article H.12.h.)

Contracting Officer

Due Date: Annual update no later than the completion date of the period of performance.

(17) Self Assessment & Information Plan - Information Security Plan (Reference Article C.2.b. 16 (2) and Article H.12.i.)

Contracting Officer

Due Date: Within 90 calendar days of the effective date of the contract.

*ISSP shall resubmit to COTR every three (3) years or when a major modification is made to the system.

(18) Common Security Configurations (Reference Article C.2.b. 16 (3) and Article H.12.j.)

Contracting Officer

Due Date: Within 90 calendar days of the effective date of the contract.

*ISSP shall resubmit to COTR every three (3) years or when a major modification is made to the system.

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity NCI COTR Items (1) through (5)

Item (6)

Items (7) through (18)

One (1) electronic copy and one (1) hard copy

One (1) electronic copy

One (1) electronic copy and one (1) hard copy

NCI Contracting Officer Item (8) Through (18) One (1) electronic copy and one (1) hard copy

c. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above Mondays through Fridays (excluding Federal Holidays) between the hours of 8:30 a.m. and 3:30 p.m. EST only. Supplies orservices scheduled for delivery on a Federal holiday shall be made the following day.

ARTICLE F.3. 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 http://www.acquisition.gov/comp/far/index.html

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FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

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

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S TECHNICAL REPRESENTATIVE (COTR)

The following Contracting Officer's Technical Representative (COTR) will represent the Government for the purpose of this contract:

To be specified prior to award.

The 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.

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 Contracting Officer hereby delegates the COTR as the Contracting Officer's authorized representative responsible for signing software license agreements issued as a result of this contract.

The Government may unilaterally change its COTR 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

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.

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1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted 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 of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions National Cancer Institute, NIH PO Box B, 244 Miller Drive Room 112 Fort Detrick MSC 1201 Frederick, MD 21702- 1201

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch C - ncibranchcinvoices@mail.nih.gov .

c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e. Invoice Matching Option. This contract requires a two-way match.

f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

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

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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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 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 as deemed appropriate by the Contracting Officer.

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.

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

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-8(b) (January 2006)

(a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Office of Public Health and Science (OPHS). The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

(b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgement or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

(c) If at any time during the performance of this contract, the Contracting Officer determines, in consultation with the OHRP,…