RFP-NIAID-DAIDS-NIHAI2013184.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 81-692, as amended

2. Request for Proposal (RFP) Number:

NIAID-DAIDS-NIHAI2013184

3. Issue Date:

4/14/2014

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Quantitative Viral Outgrowth Assay (QVOA) Service Resource

6. ISSUED BY:

Office of Acquisitions, Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health, Department of Health and Human Services 6700-B Rockledge Drive, Room 3214, MSC-7612 If using overnight delivery, use 20817 Bethesda, Maryland 20892-7612

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 3:00 PM local time on August 14, 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: George Keane

PHONE: 301-451-3690

e-MAIL: george.keane@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Michelle L. Scala Contracting Officer Office of Acquisitions Phone: (301) 451-3693 / Email:

mscala@niaid.nih.gov http://www.sam.gov

RFP Number : NIAID-DAIDS-NIHAI2013184

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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. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. 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

10. Selection of Offerors

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11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Information and Physical Access Security

13. 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

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. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Extent of Small Disadvantaged Business Participation

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION CRITERIA

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

The objective of this contract is to provide laboratory infrastructure required to quantitate latently infected cells in the blood of HIV infected individuals, using QVOA (Quantitative Viral Outgrowth Assay). The QVOA is the most accurate assay available today to measure latent virus in HIV infected patients whose viral load has been suppressed by antiretroviral therapy. This service will allow standardized QVOA measurements so that unbiased comparisons between different eradication strategies can be achieved. Widespread use of the assay will raise the standards for latent HIV detection and reduce the need for surrogate, less accurate assays, presently used by some laboratories.

ARTICLE B.2. 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(s) 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

Option Period(s):

Total

[Base Period and Option(s)]

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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) 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.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.

The following Advance Understandings will be included in any resultant contract:

a. Intellectual Property

The purpose of this contract is to provide the laboratory infrastructure required to quantitate latently infected cells in the blood of HIV infected individuals using QVOA (Quantitative Viral Outgrowth Assay). It is expected that a great majority of the new tests and assays or investigational agents to be evaluated will be proprietary, in part to the third party suppliers. For the purposes of this agreement, therapeutics ("material") includes compositions of matter, and associated information such as methods of making or using the compositions.

It is clear from the NIAID's experience that third party suppliers ("Supplier") will not provide their proprietary materials ("Material") without assurance that the intellectual property rights associated with their Material will be protected. Accordingly, to encourage a Supplier to provide their Material for production or evaluation under this contract the Contractor agrees to this Article, which requires the Contractor and its subcontractors to provide a research use license and a commercialization license option to Subject Inventions made under the contract to the Supplier as follows:

The Contractor agrees to promptly notify the NIAID and the Supplier in writing of any Subject Inventions of the Contractor, its principal investigator and/or any other employees or agents of the Contractor, whether patentable or not, which are conceived and/or first actually reduced to practice in the performance of work under this contract using a Supplier's Material (hereinafter "Contractor Invention"). The notice shall inform the Supplier of its right to the option set forth herein. This may be accomplished by attaching a copy of this Article to the notice.

(1) Single Supplier

With respect to Contractor Inventions resulting from the use of Material provided by one Supplier, the Contractor agrees to grant to the Supplier: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and (ii) a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to any Contractor Invention on terms to be negotiated in good faith by the Supplier and the Contractor, subject to the following conditions:

The Contractor will allow Provider three (3) months from the date the Contractor sends written notice to the Supplier of the existence of a Contractor Invention (or such additional period as the Supplier and the Contractor may agree) to notify the Contractor in writing, whether or not it wants to obtain an exclusive license to the Contractor Invention.

If the Supplier fails to notify the Contractor, in a timely fashion then the Contractor's obligation to offer Supplier a license option with respect to that Contractor Invention will expire, and the Contractor will be free to dispose of its interests in such Contractor Invention in accordance with the Contractor's policies. If the Contractor and the Supplier fail to reach agreement within ninety (90) days, (or such additional period as

- 6 -the Supplier and the Contractor may agree) on the terms for an exclusive license for a particular Contractor Invention, then for a period of six (6) months thereafter the Contractor will not offer to license that Contractor Invention to any third party on materially better terms than those last offered to the Supplier without first offering such terms to the Supplier, in which case the Contractor will offer the Supplier a period of thirty (30) days in which the Supplier can accept or reject the offer.

(2) Multiple Suppliers

With respect to a Contractor Invention resulting from the use of Materials provided by multiple Suppliers, but which is an improvement only to a Material of a specific Supplier, the Contractor agrees to grant to that Supplier the rights described above in (1).

With respect to any Contractor Inventions resulting from the use of Material from multiple Suppliers, but that are not improvements to or specific to a single Material, the Contractor agrees to grant to each Supplier who provided Material: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and (ii) a time-limited first option to negotiate a co-exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all such Contractor Inventions on terms to be negotiated in good faith by each Supplier and the Contractor subject to the following conditions:

The Contractor will allow each Supplier three (3) months from the time the Supplier is sent written notice by the Contractor of the existence of a Contractor Invention (or such additional period as each Suppler and the Contractor may agree) to notify the Contractor, in writing, whether or not the Supplier wants to obtain a co-exclusive license to the Contractor Invention. If a Supplier fails to notify the Contractor, in a timely fashion then Contractor's obligation to offer that Supplier a license option with respect to that Contractor Invention will expire and the Contractor will continue to offer an option to a co-exclusive license to the other Suppliers as set forth herein. If there is a single other Supplier, it shall be offered an option to an exclusive license as though it were a single Supplier. If no Supplier notifies the Contractor in a timely fashion the Contractor will be free to dispose of its interests in such Contractor Invention in accordance with the Contractor's policies.

Supplier Inventions

The Contractor agrees that notwithstanding anything herein to the contrary, any invention or discovery, whether patentable or not, which is not a Subject Invention as defined in 35 USC 201(e) 1 but arises out of an intentional and unauthorized use or modification of the Supplier's Material by the Contractor and/or any other employees or agents of the Contractor, will be the property of the Supplier (hereinafter "Supplier Invention"). The Contractor will promptly notify the Supplier in writing of any such Supplier Inventions and, at the Supplier's request and expense, the Contractor will take such further action as necessary to ensure that the Supplier shall have all right, title and interest in and to any such Supplier Inventions and give Supplier any assistance reasonably necessary to obtain patents (including causing the execution of any invention assignment or other documents). The NIAID recognizes that the Contractor may also be conducting other research using the Supplier's Material under the authority of a separate agreement with the Supplier during the term of this contract; any invention arising under such separate agreement will not be subject to the terms of this provision entitled, "Supplier Inventions."

Protection of Proprietary Data

Because the Contractor will be utilizing and evaluating Materials provided to the Government by third party Suppliers, it is essential to include provisions that will protect the proprietary rights of the Suppliers. These materials generally are supplied to the Government under conditions outlined in NIAID's standard Material Evaluation Agreement (MEA) or other appropriate documents. The Contractor shall be bound by the same terms and conditions as the Government in these agreements, with respect to the proprietary and confidential nature of the information provided by the Supplier. The Contractor agrees that its principal investigator and/or any other employees or agents of the Contractor will provide data generated under this contract exclusively to the NIAID or if directed by the NIAID to the Supplier and the FDA or other appropriate Federal agency. The Contractor understands that the NIAID may need to negotiate individual agreements with the various Suppliers to obtain Materials and that the terms of the agreements may vary.

The Contractor agrees to enter into material transfer agreements with Suppliers when requested by the Suppliers as a condition for the Contractor to receive Materials. Such Agreements shall reference this contract by contract number

- 7 -and shall be consistent with any agreement the NIAID has entered into with the Supplier to obtain Materials. In the event the Contractor reasonably objects to the terms of the material transfer agreement, the Contractor shall promptly bring such objection to the attention of the Contracting Officer for an appropriate resolution.

"Confidential Information" is scientific, business, or financial information provided by the Supplier or the NIAID Contract Officer's Representative (COR) and marked "Confidential." Oral Disclosures of Confidential Information will be reduced to writing, marked "Confidential;" and sent to Contractor within 10 days of disclosure to be considered Confidential Information. Confidential Information may not be revealed without written permission from the COR.

Similarly, designated Materials are to be considered confidential. In cases where it is not clear whether information or Materials are to be considered confidential, the Contractor should contact the COR to obtain a determination.

All materials supplied to the Contractor shall be utilized solely for contract-related research purposes and no unauthorized use or distribution of these materials shall be permitted.

Any Publication containing data generated under this contract ("Results") must be submitted for review by the COR and Supplier before submission for public presentation or publication. A "Publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information, for example a manuscript or abstract. The purpose of this review is to ensure that Publications do not contain any of NIAID's or Supplier's proprietary Confidential Information and to allow Supplier time to file patent applications, if so desired. Contract support shall be acknowledged in all Publications of Results. The COR and Supplier will review all Publications containing Results submitted to the COR and Supplier in a period of time not to exceed 120 calendar days from receipt of Results by both the COR and Supplier, and will either agree to the publication/disclosure, recommend changes and, as applicable, refer the document to the Supplier of the compound for their review. Publication of results earlier than 120 days after submission will require Supplier's written approval. When the Supplier does not consent to publication of the manuscript or abstract on the basis that Supplier's Confidential Information is included in the Publication, the COR shall notify the Contractor and the NIAID Contracting Officer. The COR is responsible for ensuring that all parties adhere to the terms and conditions of any existing Material Evaluation Agreement or other appropriate document between NIAID and the Supplier. NIAID will use its best efforts to assist and expedite the review process by the Supplier.

Should patents arise from this contract, they shall be subject to federal law governing inventions. Every patent applicant (individual or institutional) is required to provide the Government with a non-exclusive, irrevocable, paid-up license to the invention.

135 USC 201(e): The term ''subject invention'' means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement: Provided, That in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act (7 U.S.C. 2401(d)) must also occur during the period of contract performance.

b. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

1. The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

a. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

b. Fringe Benefits - Cite rate and amount

c. Overhead - Cite rate and amount

d. Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

e. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

f. Consultant Fees - Identify individuals and amounts.

g. Subcontracts - Attach subcontractor invoice(s).

h. Equipment - Cite authorization and amount.

i. G&A - Cite rate and amount.

j. Total Cost

k. Fixed Fee

l. Total CPFF

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

2. The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost Clauses in the contract.

c. Advance Copies of Press Releases

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

Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The Contractor shall ensure that the Contracting Officer's Representative (COR) has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-SPECIFICATION-WORKSTATEMENT-STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated January 29, 2014, 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. [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.]

a. Annual Progress Report

This report shall include a summation of the results achieved for the contract work for the period covered. The Annual Report shall include the following:

1) Cover page

2) Table of Contents

3) Studies in Progress: For each ongoing study this shall include the final version of the Study Proposal Document, a list of changes/modifications that occurred during the conduct of the study that differ from the Study Proposal Document, and a display of data in table and figure form, as appropriate

4) Studies Planned: For each study in the planning stage this shall include the latest version of the Study Proposal Document

5) Technical and Administrative Problems Encountered: This section shall describe all technical and administrative problems encountered over the past year and their resolution or proposed corrective action

6) Cumulative List of Samples Analyzed by QVOA: For each clinical sample analyzed, the list shall include the QVOA identification number, the dates the analysis was conducted, the QVOA titer (expressed as infectious units per million resting CD4+ T cells) and a description of the analysis in no more than 150 words

7) Cumulative List of Published Articles, Oral, and Abstract Presentations: For each publication the list shall include the publication citation, PubMed ID, and/or the title and abstract section, if available

8) A summary of all training provided for researchers to establish the QVOA during the period of the report http://www.hhs.gov/web/508/index.html http://www.hhs.gov/web/508/index.html

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9) In the event contract-supported activities are subcontracted to a third party or the Contractor utilizes the services of a consultant, the Contractor shall provide the COR with the original subcontractor/consultant reports

The first report shall cover the period May 15, 2015 through May 14, 2016 and shall be due on or before May 7, 2016. Thereafter, reports are due annually on or before the 7th calendar day following the end of the reporting period. An Annual Progress Report will not be required when the Final Report is due.

b. Final Report

This report shall consist of the work performed and results obtained for the entire contract period of performance as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. An Annual Progress Report will not be required when the Final Report is due. The Final Report shall be due 30 days prior to the expiration date of the contract. The Final Report shall include:

1) Cover Page

2) Table of Contents

3) Ongoing Studies: For each ongoing study it shall include the final version of the Study Proposal Document and a display of available data in table and figure form, if applicable

4) Cumulative List of Samples Analyzed by QVOA: For each clinical sample analyzed, the list shall include the QVOA identification number, the dates the analysis was conducted, the QVOA titer (expressed as infectious units per million resting CD4+ T cells) and a description of the analysis in no more than 150 words

5) Cumulative List of Published Articles, Oral, and Abstract Presentations: For each publication the list shall include the publication citation, PubMed ID, and/or the title and abstract section, if available.

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.)

2. Information Security and Physical Access Reporting Requirements 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 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

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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. 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 Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. 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.)

c. 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.)

d. 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.

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

e. 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.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: 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.

b. 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 COR and/or Contracting Officer upon request.

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

g. Contractor - Employee Non-Disclosure Agreement(s) 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: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. Other Reports and Deliverables Required by the Statement of Work

In addition to the reports listed above, the Contractor shall submit the following reports as required by the Statement of Work (see SECTION J, Attachment 1).

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Item Deliverables SOW Reference Recipient Delivery Schedule

1 Study Proposal Document

SOW 3. A. 1 electronic copy to COR and CO

15 calendar days after COR request

2 QVOA Analysis Report

SOW 3. C. 1 electronic copy to COR and CO

Within 30 calendar days after completion of each study

3 Assay Development Document

SOW 3. D. 1 electronic copy to COR and CO

30 calendar days following COR request

4 Standard Operating Procedures

SOW 3. D. 2) 1 electronic copy to COR and CO

7 calendar days after COR request

5 Presentations at Scientific Meetings

SOW 3. F. 1) 1 electronic copy to COR and CO

7 calendar days prior to presentation

6 Scientific Manuscript SOW 3. F. 2) 1 electronic copy to COR and CO

45 days following COR request

7 Draft Transition Plan SOW 3. H. 1 1 electronic copy to COR and CO

6 months prior to the completion date of the Contract

8 Final Transition Plan SOW 3. H. 2 1 electronic copy to COR and CO

2 months prior to the completion date of the Contract

d. Reporting Requirements for Technical Progress Reports

Item Reports Recipients Delivery Schedule

1. Annual Progress Report

1 electronic copy to COR and

CO

The first report is due on/before 05/07/2016. Thereafter, each report is due 7 calendar days before the anniversary date of the contract.

2. Annual Utilization Report

1 electronic copy to CO Due on/before the 30 th of the month following each anniversary date of the contract.

3. Final Invention Statement

1 electronic copy to CO Due on/before the expiration date of the contract.

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

1 copy to OPERA As required by FAR Clause 52.227-11.

5. Final Report 1 electronic copy to COR and

CO

Final Report is due 30 calendar days prior to the expiration date of the contract.

e. Submission of Reports/Deliverables

The above items listed in the tables named "Technical Progress Reports" and "Other Reports and Deliverables" shall be addressed and delivered to:

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Contracting Officer (CO):

Office of Acquisitions Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 6700-B Rockledge Drive, Room 3214, MSC-7612 Bethesda, Maryland 20892-7612 If using overnight delivery, use 20817

Email: mscala@niaid.nih.gov

Contracting Officer's Representative (COR) Division of AIDS National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 6700-B Rockledge Drive Bethesda, Maryland 20892 If using overnight delivery, use 20817

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 June 14, 2015. Thereafter, reports shall be due on or before the 30th Calendar day 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 Office of Acquisitions, Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 6700-B Rockledge Drive, Room 3214 Bethesda, Maryland 20892- 7612

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

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

mailto:mscala@niaid.nih.gov 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.

ARTICLE D.1. MARKING

See Statement of Work

ARTICLE D.2. SHIPPING

The Statement of Work requires the Contractor to ship infectious and non-infectious materials using shipping conditions appropriate for preserving the materials to be shipped including virus stocks, drugs, and fresh, frozen, and preserved biological samples. The Contractor will use bio-containment shipping procedures and containers that comply with International Air Transport Association (IATA) Dangerous Goods Regulations (www.iata.olrg) for shipment by air transportation or with Department of Transportation (DOT) regulations for shipment by ground transportation.

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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 Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Division of AIDS National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 6700-B Rockledge Drive Bethesda, Maryland 20892

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

The Government reserves the right to an Inspection period of 30calendar days, unless a different time period is stated when (the Record of Call/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

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).

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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 May 15, 2015 through May 14, 2016.

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:

c. Options 1 through 6 to Extend the Term of the Contract

Options Term Totals

Option 1 - Year 2 May 15, 2016 - May 14, 2017 $ TBD

Option 2 - Year 3 May 15, 2017 - May 14, 2018 $ TBD

Option 3 - Year 4 May 15, 2018 - May 14, 2019 $ TBD

Option 4 - Year 5 May 15, 2019 - May 14, 2020 $ TBD

Option 5 - Year 6 May 15, 2020 - May 15, 2021 $ TBD

Option 6 - Year 7 May 15, 2021 - May 14, 2020 $ TBD

ARTICLE F.2. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide direct labor hours/ months/years . The labor hours/months/years include/exclude vacation, holiday, and sick leave. These labor hours months/years include/exclude subcontractor labor hours/months/years. It is estimated that the labor hours/months/years are constituted as specified below and will be expended approximately as follows:

Labor [HOURS, MONTHS, YEARS]

Labor Category

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

Professional Other Professional

Support Totals

NOTE: See Section L, Instructions, Conditions, and Notices to Offerors, Paragraph 1, General Information, subparagraph d, Level of Effort, for specific level of effort requirements for the proposed contract.

b. The Contractor shall have satisfied the requirement herein if not less than % nor more than % of the total direct labor hours/months/years specified herein are furnished.

c. In the event fewer direct labor hours/months/years than the minimum specified number of direct labor hours/ months/years in the total categories are 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 direct labor hours/months/years by which the number of direct labor hours/months/years furnished is less than the number of direct labor hours/months/years specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

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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/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.

52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

http://www.acquisition.gov/far

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

1. Payment requests shall be submitted 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.

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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, DEA National Institute of Allergy and Infectious Diseases, NIH Department of Health and Human Services Room 3214 6700-B Rockledge Drive MSC 7612 Bethesda, MD 20892- 8500

E-Mail: 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…