RFP_SDCC_(amended_12-24-13).pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: NIAID

2. Request for Proposal (RFP) Number:

RFP-NIAID-DMID-NIHAI2013180

3. Issue Date:

November 22, 2013

4. Set Aside:

[ ] No [X] Yes See Part IV Section L

5. Title : Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

6. ISSUED BY:

Office of Acquisitions National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) 6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, MD 20892-7612

7. SUBMIT OFFERS TO:

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

NOTE: This solicitation has a required total page limitation of not to exceed 175 pages for the technical proposal

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 1:00pm local time on January 31, 2014. 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 as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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 subparagraph (c)(3) of FAR Clause 52.215-1, 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. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Frank Vidergar, Contract Specialist

PHONE: (301) 402-1490

e-MAIL: vidergarf@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Deadline for receipt of offerors' questions pertaining to this RFP:

Monday, January 13, 2014.

Aileene Mitchell Ford Contracting Officer Office of Acquisitions, DEA

NIAID,NIH,DHHS

RFP Number : RFP-NIAID-DMID-NIHAI2013180

- 2 -

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. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. LEVEL OF EFFORT (LOE)

f. COMMITMENT OF PUBLIC FUNDS

g. PROMOTING EFFICIENT SPENDING

h. COMMUNICATIONS PRIOR TO CONTRACT AWARD

i. RELEASE OF INFORMATION

j. PREPARATION COSTS

k. SERVICE OF PROTEST

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. Privacy Act - Treatment of Proposal Information

- 3 -

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Past Performance Information

13. Prohibition on Contractor Involvement with Terrorist Activities

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

5. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. HUBZone Small Business Concerns

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

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. EVALUATION OF OPTIONS

3. EVALUATION OF DATA SHARING PLAN

4. TECHNICAL EVALUATION CRITERIA

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

- 4 -

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

This contract provides for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support the extramural clinical research programs of NIAID's Division of Microbiology and Infectious Diseases (DMID) through the provision of: statistical design and analysis expertise; computerized systems for the collection, storage, management, reporting and quality control of study data; assistance in the preparation of study-related materials; a system for the tracking of clinical specimens; data collection and management user training; clinical site capability assessment for data collection and management; project/site management; and, a data repository for completed DMID-sponsored clinical studies.

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. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

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.

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 $ .

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:

- 5 -

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (12/1/14 - 11/30/15)

Term Options (FAR 52.217-9)

Option 1 (12/1/15 - 11/30/16)

Option 2 (12/1/16 - 11/30/17)

Option 3 (12/1/17 - 11/30/18)

Option 4 (12/1/18 - 11/30/19)

Option 5 (12/1/19 - 11/30/20)

Option 6 (12/1/20 - 11/30/21)

Subtotal - Term Options

Quantity Options (FAR 52.217-6)

Option 7 (Add 2 full-time equivalents)

Option 8 (Add 3 full-time equivalents)

Option 9 (Add 5 full-time equivalents)

Subtotal - Quantity Options

Non-Severable Options (FAR 52.217-7)

Option 10 (Initial Transition)

Option 11 (Final Transition)

Subtotal - Non-Severable Options

Extension of Services (FAR 52.217-8)

Option 12 (Add maximum of 6 months) In accordance with period just ended.

In accordance with period just ended.

In accordance with period just ended.

Total Base Period and Options

ARTICLE B.4. 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) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.5. 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.

- 6 -

All data and other information pertaining to product supplied by Companies serving as industry collaborators ("the companies") for the clinical trials to be undertaken by the Contractor, or supplied by the Contracting Officer's Representative (COR), shall be assumed to be confidential unless specifically identified as not confidential in writing by the COR. The Contractor agrees that its Principal Investigator and/or any other employees or agents of the Contractor will provide the data generated under this contract exclusively to the NIAID or, if directed by the NIAID, to the Companies, the U.S. Food and Drug Administration (FDA) or other third parties.

- 7 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

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 November 22, 2013, 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.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

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.]

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

- 8 -

2. 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.

3. Information Security and Physical Access Reporting Requirements

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

a. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

- 9 -

d. IT Security Certification and Accreditation (IT-SC&A)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

e. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

4. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

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 first annual utilization report shall be due on or before November 30, 2015. Thereafter, reports shall be due on or before the last day of the month following the reporting period. 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 (NIAID) Office of Acquisition 3rd floor 5601 Fishers Lane, Room Bethesda, Maryland 20892-

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.

- 10 -

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.

- 11 -

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.

- 12 -

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 Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID) Office of Clinical Research Affairs 5601 Fishers Lane, Bethesda, 20892

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

- 13 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from December 1, 2014 through November 30, 2015.

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 Term Option 1 12/1/15 - 11/30/16 Term Option 2 12/1/16 - 11/30/17 Term Option 3 12/1/17 - 11/30/18 Term Option 4 12/1/18 - 11/30/19 Term Option 5 12/1/19 - 11/30/20 Term Option 6 12/1/20 - 11/30/21 Non-Severable Option 11- Final Transition

TBD - 11/30/21

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 [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

i. Technical Progress Reports

Item Reports Recipients Delivery Schedule

1. Monthly Electronic Technical

Progress Report 1 secure electronic copy to both COR and CO

The first report is due on or before January 15, 2015. Thereafter, each report is due on or before the 15 th of each month following each reporting period.

2. Monthly Electronic Study Status Report

1 secure electronic copy to both COR and CO

The first report is due on or before January 15, 2015. Thereafter, each report is due on or before the 15 th of each month following each reporting period.

3. Monthly Electronic Expenditure Report

1 secure electronic copy to both COR and CO

The first report is due on or before January 15, 2015. Thereafter, each report is due on or before the 15 th of each month following each reporting period.

4. Semi-Annual Progress Report

1 secure electronic copy to both COR and CO Hard copies only as directed by the CO and/or

COR

The first report is due on or before June 15, 2015. Thereafter, each report is due on or before the 30 th of the month following each six-month reporting period. Monthly reports will not be submitted the month the Semi-Annual Technical Progress Report is due. A Semi-Annual Technical Progress Report is not due when an Annual Technical Progress Report or Final Report is due.

- 14 -

Item Reports Recipients Delivery Schedule

5. Annual Progress Report 1 secure electronic copy to both COR and CO Hard copies only as directed by the CO and/or

COR

The first report is due on/before January 15, 2016.

Thereafter, each report is due on/before the 30 th of the month following each anniversary date of the contract. Monthly and semi-annual reports will not be submitted the month the annual report is due.

6. Annual Technical Progress Report for Clinical Research Study Populations

1 secure electronic copy to both COR and CO

The first report is due on/before January 15, 2016.

Thereafter, reports are due on/before the 30 th of the month following each anniversary date of the contract.

7. Draft Final and Final Report and Summary of Salient Results

1 secure electronic copy to both COR and CO

Draft Final Report is due 90 calendar days prior to the completion date of contract.

Final Report is due on/before the completion date of the contract.

8. Annual Utilization Report 1 secure electronic copy to both COR and CO

Due on/before the 30 th of the month following each anniversary date of the contract.

9. All reports and documentation including the invention disclosure report, the confirmatory license, and the government support certification

1 secure electronic copy to

OPERA

As required by FAR Clause 52.227-11.

ii. Other Reports and Deliverables

Item Reports SOW reference Recipients Delivery Schedule

10. Computer-based system for clinical data management/ collection, storage and quality control, compliant with current industry standards (e.g.

CDISC), federal regulations and NIAID informatics requirements

III.1. 1 secure electronic copy of memo confirming system readiness to CO and COR

Due to be in place and fully operational within 60 calendar days from the effective date of the contract

11. Electronic specimen tracking system

III.8. 1 secure electronic copy of memo confirming system readiness to CO and COR

Due to be in place and fully operational within 60 calendar days from the effective date of the contract

12. Draft and Final Quality Management Plans to cover all contract activities, including a plan to identify gaps

III.2.c. 1 secure electronic copy to CO and COR of draft and final plans

1 secure electronic copy of QMP

Draft Plan due within 30 calendar days from the effective date of the contract for CO and COR review/approval

Final Plan due within 14 days of receiving

- 15 -

Item Reports SOW reference Recipients Delivery Schedule performance reports to COR comments from the COR on the draft document , with prior CO/COR approval due as specified by the COR

Updated Plan versions due to CO and COR for approval as specified by the COR

Performance reports from the QMP for approval by the COR on a schedule to be determined by the

COR.

13. Clinical Study Websites III.4. 1 secure electronic copy of memo confirming website readiness to CO and COR

Due to be in place and fully operational within 60 calendar days from the effective date of the contract

14. SAE reconciliation Process

SOP

III.5.b.1) c) 1 secure electronic copy to COR

SOP and any updates determined by the COR and/or DMID staff designated by the COR

SAE reconciliation reports to be provided to the DMID-CROMS contractor as specified in the SAE Reconciliation Process

SOP

15. Reports to DMID and other personnel designated by DMID regarding a study meeting pre-specified protocol criteria

III.5.b.1) d) 1 secure electronic copy to COR of reporting table/ system

As determined by the COR and/or DMID staff designated by the COR

16. Reports for Safety Oversight Structures

III.5.b.1) e) Secure electronic copies as determined by the COR and/or DMID staff designated by the COR

As determined by the COR and/or DMID staff designated by the COR

17. Study site-specific reports III.5.b.1) f) 1 secure electronic copy to COR

As determined by the COR and/or DMID staff designated by the COR

18. Reports to support clinical site monitoring requirements

III.5.b.1) g) 1 secure electronic copy of memo confirming system readiness to CO and COR

A system to provide reports to support clinical site monitoring shall be in place and fully operational within 60 calendar days from the effective date of the contract.

- 16 -

Item Reports SOW reference Recipients Delivery Schedule

19. Data via electronic data exchange system with DMID- CROMS data system

III.5.b.1) i) 1 secure electronic copy of memo confirming system readiness to CO and COR

Due within 60 calendar days from the effective date of the contract

Related reports and data to be exchanged and timing of that exchange to be determined by the COR and/or DMID staff designated by the COR.

20. Data and related reports via electronic data exchange system with the NIAID-wide information system

III.5.b.1) j) 1 secure electronic copy to COR

As determined by the COR and/or DMID staff designated by the COR

21. Ad hoc reports III.5.b.1) k) 1 secure electronic copy to the requestor

At the requested time

22. Regulatory reports III.5.b.2) c) Secure electronic copies as determined by the COR and/or DMID staff designated by the COR

As determined by the COR and/or DMID staff designated by the COR

23. Statistical Analysis Plan (SAP) III.6.b.1) Secure electronic copies as determined by the COR and/or DMID staff designated by the COR

Prior to each clinical study/ trial implementation, as determined by the COR and/or DMID staff designated by the COR

24. Statistical designs, analysis plans and study-specific analyses for regulatory submissions

III.6.b.4) Secure electronic copies as determined by the COR and/or DMID staff designated by the COR

As determined by the COR and/or DMID staff designated by the COR

25. Clinical data entry system User's Manual and Training Data Entry Module

III.7.a. and b. 1 secure electronic copy of each to CO and COR

Each is due within 60 calendar days from the effective date of the contract

26. Site Visit Reports III.7.c. 1 secure electronic copy to CO and

COR

Due within 14 calendar days following completion of each site training visit

27. Help Line for SDCC questions III.7.d. 1 secure electronic copy of memo confirming system readiness to CO and COR

1 secure electronic monthly report on current Help Line operations status and key FAQs to CO and COR

Due to be in place and fully operational within 60 calendar days from the effective date of the contract

Help line report on current help line operations status and key frequently asked questions (FAQs) due monthly as specified by

COR

- 17 -

Item Reports SOW reference Recipients Delivery Schedule

28. Site Assessment Visit Reports III.7.e. 1 secure electronic copy to CO and

COR

Due within 15 calendar days following completion of each site assessment visit

29. SOP for data storage and data transfers

III.9. 1 secure electronic copy to COR

Due within 60 calendars days from the effective date of the contract

30. Overall Project Management Plan

III.10.a.1) 1 secure electronic copy to CO and

COR

Due within 60 calendar days from the effective date of the contract

31. Contract Initiation Meeting and Agenda

III.10.b.1. 1 secure electronic copy each of draft and final Agendas

Initiate/hold Contract Initiation Meeting within 30 calendar days after the effective date of the contract Draft and final agendas due as specified by CO and/or COR

32. Monthly status meetings/ teleconferences with agenda/ materials distributed to participants

III.10.b.2. Copies as determined by the COR and/or DMID staff designated by the COR

As determined by the COR and/or DMID staff designated by the COR

33. Annual Site Visit Reports III.10.b.3. d) 1 secure electronic copy to CO and

COR

Report due within 30 calendar days of completion of each annual site visit

34. Study/trial-specific project management support services

III.10.c.1) Copies as determined by the COR and/or DMID staff designated by the COR

As determined by the COR and/or DMID staff designated by the COR prior to implementation

35. Draft Final Transition Plan III.11.OPTIONS.

Option 11:

Final Transition Effort

1 secure electronic copy of report to CO and COR Hard copies only as directed by the CO and/or COR

Due 12 months prior to the completion date of the contract

36. Final Transition Plan III.11.OPTIONS.

Option 11:

Final Transition Effort

1 secure electronic copy of report to CO and COR Hard copies only as directed by the CO and/or COR

Due 6 months prior to the completion date of the contract

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

Addressee(s) Deliverable Item No. Quantity COR only (to be determined) 14-15, 17, 20, 29 1 COR, CO (both to be determined) 1-8, 10-13, 18-19, 25-28, 30, 33, 35-36 1 to each addressee

Office of Policy for Extramural Research Administration (OPERA)

9 1

- 18 -

Addressee(s) Deliverable Item No. Quantity To be determined 16, 21-24, 31-32, 34, To be determined

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide 41.40 full-time equivalents (FTEs) per year. The labor hours should Include vacation, holiday, and sick leave, and they should Include subcontractor labor hours. It is estimated that the number of FTEs is constituted as specified below and will be expended approximately as follows:

Labor (in Full-Time Equivalents [FTEs])

Labor Category

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Principal Investigator

To be decided -->

-----> -----> -----> -----> -----> TBD

Professional To be decided -->

-----> -----> -----> -----> -----> TBD

Technical & Support

To be decided -->

-----> -----> -----> -----> -----> TBD

Totals (FTEs)

41.40 41.40 41.40 41.40 41.40 41.40 41.40

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor effort specified herein is furnished.

c. In the event less than the minimum specified percent of direct labor effort in the total categories is used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of FTEs by which the number of direct labor FTEs funished is less than the number of direct labor FTEs specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. 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/far .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

- 19 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

To be specified prior to award.

The COR 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (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. The "INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4" is 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.

- 20 -

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 in hard copy 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 electronic copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions

NIAID

Email: NIAIDOAInvoices@niaid.nih.gov The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number. [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 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 Institute of Allergy and Infectious Diseases .

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

NIAID_MIDBRCB .

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.

- 21 -

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.

g. The Contract Title is:

Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

h. Contract Line Items as follows:

Line Item # Line Item Description To be determined at time of contract award. To be determined at time of contract award.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, 52.232-99 (DEVIATION) (August 2013)

This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012, and the extension to that policy provided by OMB Policy Memorandum M-13-15, Extension of Policy to Provide Accelerated Payment to Small Business Subcontractors, dated July 11, 2013.

a. Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.

b. Include the substance of this article, including this paragraph (b), in all subcontracts with small business concerns.

c. The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

ARTICLE G.5. 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.

- 22 -

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 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) will be prepared on February 15 of each contract year, beginning with February 15, 2016.

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 may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

- 23 -

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH.

The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html.

ARTICLE H.3. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes;

or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

- 24 -

ARTICLE H.7. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-6, Option for Increased Quantity; FAR Clause 52.217-7, Option for Increased Quantity - Separately Priced Line Item; FAR Clause 52.217-8, Option to Extend Services; and FAR Clause 52.217-9, Option to Extend the Term of the Contract, set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST - OPTION Article in SECTION B of this contract.

ARTICLE H.8. INFORMATION AND PHYSICAL ACCESS SECURITY

A. HHS-Controlled Facilities and Information Systems Security

a. To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

b. To gain routine physical access to an HHS-controlled information system, and/or access to sensitive data or information, the…