MIDBRR_RFP_4-3-15_(w_atts.).pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority:

2. Request for Proposal (RFP) Number:

RFP-NIAID-DMID-NIHAI2015039

3. Issue Date: 4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Microbiology and Infectious Diseases Biological Research Repository (MID-BRR)

6. ISSUED BY:

Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, Room 3B44, MSC 9821 Rockville, MD 20892-9821

7. SUBMIT OFFERS TO:

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

Page limitation: The Technical Proposal may not exceed 175 pages.

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 12:00 noon local time on July 2, 2015. 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: (240) 669-5136

e-MAIL: vidergarf@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

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

Wednesday, May 6, 2015. Aileene Mitchell Ford

Contracting Officer Office of Acquisitions, DEA

NIAID, NIH, DHHS

April 20, 2015 http://www.sam.gov

RFP Number : RFP-NIAID-DMID-NIHAI2015039

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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. Past Performance Information

13. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

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

7. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

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

3. Salary Rate Limitation

4. Small Business Subcontracting Plan

5. HUBZone Small Business Concerns

6. Total Compensation Plan

7. Other Administrative Data

8. Qualifications of the Offeror

9. Subcontractors

10. Proposer's Annual Financial Report

11. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. EVALUATION OF OPTIONS

3. TECHNICAL EVALUATION FACTORS

4. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

5. PAST PERFORMANCE FACTOR

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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 operation, maintenance, and continual improvement of a central repository for the acquisition, authentication, production, preservation, storage, and distribution of a broad range of unique and quality assured research materials to aid the infectious disease research community in the development and evaluation of vaccines, therapeutics, and diagnostics. This program will include biodefense, non-biodefense, and emerging infectious disease research materials. The repository inventory will include organisms as well as reagents.

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 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:

BASE PERIOD & TERM OPTIONS

Period Level of

Effort (FTEs) per Year

Contract Year Period of Performance

Estimated Cost ($)

Fixed Fee ($) Estimated Cost Plus

Fixed Fee ($)

Base 46.00 Year 1 4/29/16

- 4/28/17

TERM OPTIONS (FAR 52.217-9)

Option 1 46.00 Year 2 4/29/17

- 4/28/18

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BASE PERIOD & TERM OPTIONS

Option 2 46.00 Year 3 4/29/18

- 4/28/19

Option 3 46.00 Year 4 4/29/19

- 4/28/20

Option 4 46.00 Year 5 4/29/20

- 4/28/21

Option 5 46.00 Year 6 4/29/21

- 4/28/22

Option 6 46.00 Year 7 4/29/22

- 4/28/23

Subtotals - Term Options

Years 2 - 7

4/29/16

- 4/28/23

QUANTITY OPTIONS to Increase Level of Effort (FAR 52.217-6) Option Level of

Effort (FTEs) per Year

Contract Year Period of Performance

Estimated Cost

Fixed Fee

Estimated Cost Plus

Fixed Fee ($)

Option 7A 0.5 Year 1 4/29/16

Option 8A 1 Year 1 4/29/16

- 4/28/17

Option 9A 2 Year 1 4/29/16

- 4/28/17

Maximum Additional Allowed

24 Year 1 4/29/16

Option 7B 0.5 Year 2 4/29/17

Option 8B 1 Year 2 4/29/17

- 4/28/18

Option 9B 2 Year 2 4/29/17

- 4/28/18

Maximum Additional Allowed

24 Year 2 4/29/17

Option 7C 0.5 Year 3 4/29/18

- 4/28/19

Option 8C 1 Year 3 4/29/18

- 4/28/19

Option 9C 2 Year 3 4/29/18

- 4/28/19

Maximum Additional Allowed

24 Year 3 4/29/18

- 4/28/19

Option 7D 0.5 Year 4 4/29/19

- 4/28/20

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QUANTITY OPTIONS to Increase Level of Effort (FAR 52.217-6) Option 8D 1 Year 4 4/29/19

- 4/28/20

Option 9D 2 Year 4 4/29/19

- 4/28/20

Maximum Additional Allowed

24 Year 4 4/29/19

- 4/28/20

Option 7E 0.5 Year 5 4/29/20

- 4/28/21

Option 8E 1 Year 5 4/29/20

- 4/28/21

Option 9E 2 Year 5 4/29/20

- 4/28/21

Maximum Additional Allowed

24 Year 5 4/29/20

- 4/28/21

Option 7F 0.5 Year 6 4/29/21

- 4/28/22

Option 8F 1 Year 6 4/29/21

- 4/28/22

Option 9F 2 Year 6 4/29/21

- 4/28/22

Maximum Additional Allowed

24 Year 6 4/29/21

- 4/28/22

Option 7G 0.5 Year 7 4/29/22

Option 8G 1 Year 7 4/29/22

- 4/28/23

Option 9G 2 Year 7 4/29/22

- 4/28/23

Maximum Additional Allowed

24 Year 7 4/29/22

Maximum Additional Allowed

24 Life of Project 4/29/16

TRANSITION OPTIONS (FAR 52.217-7)

Option Anticipated

Level of Effort (FTEs)

Contract Year Period of Performance

(Approx.)

Estimated Cost ($)

Fixed Fee ($) Estimated Cost Plus

Fixed Fee ($)

Option 10 Beginning Transition

___ Year 1 4/29/16

- 7/28/16

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TRANSITION OPTIONS (FAR 52.217-7)

Option 11 Ending Transition

___ Year 7 1/28/23

OPTION TO EXTEND SERVICES for no more than 6 additional months over life of the Contract (FAR 52.217-8)

Option Level of Effort (FTEs)

Contract Year(s)

Period of Performance

Estimated Cost ($)

Fixed Fee ($) Estimated Cost Plus

Fixed Fee ($) Option 12 As necessary As necessary As necessary

In accordance with period just ended.

In accordance with period just ended.

In accordance with period just ended.

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 Contractor will be responsible for developing and subsequently maintaining and managing a web-based material ordering system, the data for which will be provided initially by the Government but updated by the Contractor. The web portal, which is to be used for ordering and depositing materials to/from the MID-BRR, shall have the same look as the current website. NIAID will provide the contractor screenshots of the mandatory web-portal design to ensure continuity of the website appearance. The Contractor shall develop the website in accordance with the specifications outlined in the Web Portal section of the Statement of Work.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated March 23, 2015, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

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.

3. Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each AnnualProgress Report:

1. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

2. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

a. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

http://www.hhs.gov/web/508/index.html

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b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html) or listed on the U.S. National Select Agents Registry restricted experiments website ( http://www.selectagents.gov/ Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html);

c. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Annual Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report.

b. Other Reports/Deliverables

1. 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.

2. Multiple Principal Investigators Leadership Plan The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

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 . Thereafter, reports shall be due on or before the 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:

http://www.selectagents.gov/Regulations.html http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html

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Contracting Officer National Institutes of Health

Office of Acquisition

, 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.

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

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

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

ARTICLE D.1. PACKAGING

Biohazardous materials shall be packaged in accordance with IATA Dangerous Goods Regulations. http:// www.iata.org/publications/dgr/Pages/index.aspx.

ARTICLE D.2. MARKING

Biohazardous materials shall be marked/labeled in accordance with IATA Dangerous Goods Regulations.

ARTICLE D.3. SHIPPING

Biohazardous materials shall be shipped in accordance with IATA Dangerous Goods Regulations. http://www.iata.org/ publications/dgr/Pages/index.aspx

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

c. Inspection and acceptance will be performed at:

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 calendar 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 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

Alternate I (April 1984) is not applicable to this contract.

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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 April 29, 2016 through April 28, 2017.

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 4/29/17 - 4/28/18 Term Option 2 4/29/18 - 4/28/19 Term Option 3 4/29/19 - 4/28/20 Term Option 4 4/29/20 - 4/28/21 Term Option 5 4/29/21 - 4/28/22 Term Option 6 4/29/22 - 4/28/23 Option 11 - Ending Transition To be decided

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. Technical Progress Reports

Item Reports Recipients Delivery Schedule

1. Monthly Progress Report 1 electronic copy to COR and CO

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

2. Annual Progress Report 1 electronic copy to COR and CO

Each report is due on/before the 30 th of the month following each anniversary date of the contract. Monthly Reports will not be submitted the month the Annual Progress Report is due.

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

4. Final Invention Statement 1 electronic copy to CO Due on/before completion date of the contract.

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

1 paper copy to OPERA

1 electronic copy to CO

As required by FAR Clause 52.227-11.

6. Draft Ending and Finalized Ending Report and Summary of Salient Results

1 electronic copy to COR and CO

Draft Final Report is due 60 calendar days prior to the completion date of contract.

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

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b. Other Reports and Deliverables (Delivery Schedule)

Item Deliverables SOW Reference Recipient Delivery Schedule

1. IT System Security Plan Item 3)B.1.a.3) 1 elec. copy to COR, CO Due within 30 calendar days after the effective date of the contract.

2. Continuous Diagnostic and Mitigation Report

3)B.1.a.3) a) 1 elec. Copy to COR, CO NIAID

ISSO

Monthly, emailed to ISSO and COR using SEFT.

3. Security Back-up Plan Item 3)B.1.a.5) 1 elec. copy to COR, CO Due within 30 calendar days after the effective date of the contract.

4. Operational Recovery Plan Item 3)B.1.a.6) 1 elec. copy to COR, CO Due within 30 calendar days after the effective date of the contract.

5. Plan for recording container history for all MID-BRR materials

Item 3)B.1.c. 1 elec. copy to COR, CO Due within 60 calendar days after the effective date of the contract.

6. Format for quarterly data reports on MID-BRR usage by the research community

Item 3)B.1.d. 1 elec. copy to COR, CO Due within 60 calendar days after the effective date of the contract.

7. Ad hoc reports and data extracts Item 3)B.1.e. 1 elec. copy to COR, CO As requested by COR and/or designees.

8. QA/QC Plan Item 3)C.1.a. 1 elec. copy to COR, CO Within 60 calendar days after the effective date of the contract

9. Cycle count inventory Report Item 3)C.1.a.4) ix) 1 elec. copy to COR, CO Annually, to be included along with annual report.

10. QA/QC Program SOPs Item 3)C.1.b.2) 1 elec. copy to COR, CO Within 60 calendar days after the effective date of the contract

11. QA/QC Corrective Action Reports Item 3)C.1.b.4) 1 elec. copy to COR, CO Quarterly

12. Interim Audit Reports/Responses Item 3)C.1.c.4) 1 elec. copy to COR, CO Within 20 calendar days after the completion of each audit

13. Final Audit Reports/Responses Item 3)C.1.c.5) 1 elec. copy to COR, CO Within 30 calendar days after the completion of corrective actions in response to audits

14. Biosafety/Biosecurity and Security Plan

Item 3)C.2.a.1) 1 elec. copy to COR, CO Within 60 calendar days after the effective date of the contract

15. Report of all accidents and incidents involving the MID-BRR

Item 3)C.2.b.5) 1 elec. copy to COR, CO Within 24 hours of incident

16. Scientific Working Group (SWG) Recommendations for Membership

Item 3)D.1.a. 1 elec. copy to COR, CO Within 3 months after the effective date of the contract

17. SWG monthly reports for newly added items to the catalog

D.1.c.2) 1 elec. Copy to COR, SWG members

Monthly, emailed to SWG members, COR.

18. Draft Web Portal maintenance Plan Item 3)D.3.e. 1 elec. copy to COR, CO Within 30 calendar days after the effective date of the contract

19. Finalized Web Portal maintenance Plan

Item 3)D.3.f. 1 elec. copy to COR, CO Within 7 calendar days after receipt and agreement on comments from the COR initiate modifications on the Draft Web Portal Plan. Final Web Portal Plan due within 45 calendar days after the effective date of the contract.

20. Outreach Activities Plan Item 3)D.4.b. 1 elec. copy to COR, CO Within 60 calendar days after the effective date of the contract

21. Monthly Meetings/Tele-conferences Agenda and Materials

Item 3)E.3.b.2) 1 elec. copy to COR, CO Due on/before 1 calendar day prior to the meeting.

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Item Deliverables SOW Reference Recipient Delivery Schedule

22. HHS Interim Section 508 Annual

Report Item 3)D.3.d. 1 elec. copy to CO, COR 120 calendar days prior to the expiration of each term option

22. Annual Site Visit Reports and Organizational Materials

Item 3)E.3.c.2) 1 elec. copy to COR, CO Agenda due on/before 14 calendar days prior to the visit. Summary due within 30 calendar days after completion of each visit.

23. Options 7-9: Implementation Plan 1 elec. copy to COR, CO As requested by COR and/or designees.

24. Option 11: Draft Ending Transition Plan

1 elec. copy to COR, CO 8 months prior to the completion date of the contract as requested by COR and/or designees.

25. Option 11: Finalized Ending Transition Plan

1 elec. copy to COR, CO 6 months prior to the completion date of the contract as requested by PO COR and/or designees.

26 Stored organisms and reagents Option 11: Ending Transition Plan

COR or NIAID designee 3 months prior to the completion date of the contract as requested by PO/ CO and/or designees.

27 Repository data Option 11: Ending Transition Plan

COR or NIAID designee 3 months prior to the completion date of the contract as requested by PO/ CO and/or designees.

28 Government-furnished property Option 11: Ending Transition Plan

COR or NIAID designee 3 months prior to the completion date of the contract as requested by PO/ CO and/or designees.

Note: It is not due to an oversight that the Beginning Transition Plan is not mentioned in the table above. The contract that will ultimately result from this Acquisition Plan will have an April 2016-April 2023 period of performance. The 4/16-4/23 contractor will not need to develop a Beginning Transition Plan because that plan will already have been developed by the current (i.e., 4/10-4/16) contractor-ATCC-as ATCC's Ending Transition Plan. That is, the outgoing contractor's Ending Transition Plan will function as the incoming contractor's Beginning Transition Plan.

The above items shall be addressed and delivered to:

Contracting Officer's Representative (COR) Name (To be decided) Email Address (To be decided)

Contract Specialist Name (To be decided) Email Address (To be decided)

ARTICLE F.3. LEVEL OF EFFORT

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

b. In the event fewer FTEs than the minimum specified number of direct labor FTEs 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 FTEs by which the number of direct labor FTEs furnished is less than the number of direct labor FTEs specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

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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.

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 decided.

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

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

FINANCIAL REPORT

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

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

a. The original invoice shall be submitted to the following designated billing office:

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

b. One copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions

Room

MSC

E-mail:

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."]

Central Point of Distribution:

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. 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."]

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."

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ARTICLE G.4. INDIRECT COST RATES

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

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

ARTICLE G.5. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at: http://oamp.od.nih.gov/sites/default/ files/appendix_q_hhs_contracting_guide.pdf.

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 Annually as follows on [Insert Dates].

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 http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://www.cpars.gov

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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. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

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

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

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

ARTICLE H.3. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID

MOLECULES (Including Human Gene Transfer Research)

All research projects (both NIH-funded and non-NIH-funded) involving recombinant or synthetic nucleic acid molecules that are conducted at or sponsored by an entity in the U.S. that receives any support for recombinant or synthetic nucleic acid research from NIH shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) available at: http://oba.od.nih.gov/rdna/ nih_guidelines_oba.html). All NIH-funded projects abroad that include recombinant or synthetic nucleic acid molecules must also comply with the NIH Guidelines.

The NIH Guidelines stipulate biosafety and containment measures for recombinant or synthetic nucleic acid research, which is defined in the NIH Guidelines as research with (1) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or (3) molecules that result from the replication of those described in (1) or (2). The NIH Guidelines apply to both basic and clinical research.

Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines.

Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of the contract for any work related to recombinant or synthetic nucleic acid research or a requirement for the Contracting Officer to approve any or all recombinant or synthetic nucleic acid molecule projects under this contract. This includes the requirement for the institution to have an Institutional Biosafety Committee (IBC) registered with NIH OBA that complies with the requirements of the NIH Guidelines. Further information about compliance with the NIH Guidelines can be found on the NIH Office of Biotechnology Activities (OBA) website available at: http://oba.od.nih.gov/rdna_ibc/ibc.html.

http://oba.od.nih.gov/rdna/nih_guidelines_oba.html http://oba.od.nih.gov/rdna/nih_guidelines_oba.html http://oba.od.nih.gov/rdna_ibc/ibc.html

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ARTICLE H.4. 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.5. 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.6. 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.7. 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.8. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

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

ARTICLE H.9. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

http://www.pubmedcentral.nih.gov http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html

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c. The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; Web site: ( http://www.aphis.usda.gov/ animal_welfare).

(End of Clause)

ARTICLE H.10. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http:// grants1.nih.gov/grants/olaw/references/phspol.htm

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated , which is incorporated by reference.

ARTICLE H.11. 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…