SOLICITATION HT9425-24-Q-0020 1-25-24.pdf

SEE ADDENDUM

(No Collect Calls)

HT942524Q0020 25-Jan-2024

b. TELEPHONE NUMBER

240-313-8523

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 05 Feb 2024

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

HT94259. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

JEFF FLOOK

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

ARMY MED RES ACQ ACTIVITY

808 SCHREIDER ST

FORT DETRICK MD 21702

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0980 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

ARMY MED RES INST OF DISEASE - MM

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

541714

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF43

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

HT942524Q0020

Section SF 1449 - CONTINUATION SHEET

STATEMENT OF REQUIREMENT

Statement of Requirements

A quote is being requested in response to this solicitation HT9425-24-Q-0020. The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a Firm Fixed Price (FFP) service contract on behalf of the U.S.

Army Medical Research Institute of Infectious Diseases (USAMRIID) located at Fort Detrick, 1425 Porter Street, Frederick, MD 21702.

USAMRIID has a requirement for a service contract to provide for the storage of DNA vaccine materials as well as associated shipment services. The contract will consist of one, 12-month base period followed by four, 12-month option periods for a total of 60 months. The storage facility must be within a fifty (50) mile vicinity of Frederick, Fort Detrick, Maryland.

The storage facility must have Good Manufacturing Practises (GMP) certification to include quality assurance to ensure medical products are stored under consistently controlled to quality standards. Materials to be stored are DNA vaccines targeting hantaviruses and alphaviruses: 1) bacterial cell banks that need to be stored at -70C or colder; 2) vialed plasmid DNA – vaccine vials that need to be stored at -20C or colder. The quantity to be stored will be up to eight boxes of cell banks and up to 6,000 vaccine vials. In addition to storage, the contractor shall have the capacity to ship DNA vaccine materials to clinical sights and/or manufacturers.

PWS

PERFORMANCE WORK STATEMENT (PWS)

FOR

DNA VACCINE STORAGE (GMP)

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES

(USAMRIID)

SECTION 1 PURPOSE

1.1. INTRODUCTION

1.1.1. Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions - therapeutics, vaccines, diagnostics, and information that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S.

Army Medical Research and Materiel Command (USAMRMC) at Fort Detrick, located in Frederick, MD.

1.2. MISSION

1.2.1. The mission of USAMRIID is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Specifically, the Viral Immunology Branch seeks to understand the relationship between human immunity and viral diseases and use that knowledge to develop medical countermeasures to protect the Warfighter.

1.3. BACKGROUND

1.3.1. USAMRIID has developed several DNA vaccines that have advanced in Phase 1 and Phase 2 clinical trials. It is necessary that vaccines used in clinical trials be manufactured under Good Manufacturing Practices (GMP) or at another standard suitable by the Regulatory Agencies for use in humans. Several of USAMRIID’s DNA vaccines, consisting of bacterial cell banks stored at -65C or colder and DNA vaccine product stored at -15C or colder, are currently stored in a facility and need to be consolidated under this contract. It is expected that future vaccine Lots would also be stored under this contract.

1.4. SCOPE

1.4.1. The primary objective of this requirement is to store the vaccine materials under GMP conditions and to ship product under well-regulated and well documented conditions to sites as directed (e.g., to clinical trial test sites or to facilities for stability testing).

1.5. ORGANIZATIONAL CONFLICT OF INTEREST (OCI) & NON-DISCLOSURE STATEMENT (NDS)

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage.

An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing, or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine, or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract.

Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

1.5.1. OCI (Deliverable 1, Attachment 01). This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category Two (2) – Program and/or Administrative Support, which falls within the scope of the PWS. The Contractor shall provide an OCI certification of OCI status from all sub- Contractors (if applicable), teaming partners or consultants prior to tasking any such party under the contract. In additions, the Contractor shall ensure that all Contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets.

1.5.2. NDS (Deliverable 2, Attachment 02). The Contractor shall sign the NDS and ensure that all staff including all employees, subcontractors, and consultants, assigned to, or performing under the contract, execute, sign, and adhere to the terms of the NDS. Assignment of staff who have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor. A completed NDS is required for each employee assigned under the contract, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1. Place of Performance

Services shall be provided at the Contractor’s facility.

2.2. DUTY HOURS

2.2.1. USAMRIID’s core hours of operation are generally Monday through Friday, 0900 to 1500, daily except U.S.

Federal Holidays. Federal workers typically work eight (8) hours per day, 40 hours per week.

2.2.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays:

2.2.2.1. New Year’s Day, 1 January

2.2.2.2. Martin Luther King’s Birthday, 3rd Monday in January

2.2.2.3. President’s Day, 3rd Monday in February

2.2.2.4. Memorial Day, last Monday in May

2.2.2.5. Juneteenth, 19 June

2.2.2.6. Independence Day, 4 July

2.2.2.7. Labor Day, 1st Monday in September

2.2.2.8. Columbus Day, 2nd Monday in October

2.2.2.9. Veteran’s Day, 11 November

2.2.2.10. Thanksgiving Day, 4th Thursday in November

2.2.2.11. Christmas Day, 25 December

2.3. NON-PERSONAL SERVICES

2.3.1. This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the government shall neither supervise Contractor personnel nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the government assign tasks or prepare work schedules for individual Contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the Contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor’s responsibility to notify the Contractor Officer (KO) immediately.

2.3.2. Severable/Non-Severable Services. This PWS identifies services that are severable in nature.

2.3.3. Inherently Governmental Functions. This PWS has been reviewed and contains no services that are inherently governmental functions, as defined in FAR Part 2.1.

2.3.4. Acquisition Functions Closely Associated with Inherently Governmental Functions. This PWS has been reviewed and contains no acquisition functions closely associated with inherently government functions.

2.4. CONTRACT MANAGEMENT

2.4.1. Government Management. The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. If the COR is not available, a secondary Point of Contact (POC) identified by the COR will assume the COR’s responsibilities.

2.4.2. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contact for coordination for the contract; approve or disapprove Contractor invoices; review and accept or reject all Contractor technical deliverables; monitor funds obligated and disbursed; conduct surveillance by uploading a monthly report in the Procurement Integrated Enterprise Environment (PIEE), Surveillance and Performance Monitoring (SPM); and conduct other activities as may be specified by the COR appointment letter.

2.4.3. Contractor Management. The Contractor shall designate a single Program Manager (PM) to be the Contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning Contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO, Contract Specialist, and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills. The name of the PM and an alternate (who shall act for the Contractor when the manager is absent) shall be designated in writing to the KO. The Manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Manager or alternate shall be available (in-person or virtually) as required.

2.4.3.1. The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor shall ensure that all Contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.4.3.2. Contract Management Plan (CMP) (Deliverable 3). The Contractor shall revise its CMP as changes occur and submit revised CMP to the COR, for review and approval. The Contractor’s designated Program Manager shall serve as a single point of contact for addressing contract issues, quality issues, and overall, Contractor performance.

Following Government approval of the revised plan, the plan shall be applied by the Contractor to manage, track, and evaluate project or task performance.

2.4.3.3. Quality Control Plan (QCP) (Deliverable 4). After contract award, but not later than commencement of services, the Contractor shall submit a QCP to the COR for review. The QCP shall, at minimum, include (a) a plan for providing services by appropriately qualified personnel that includes methodology for doing so; and (b) a plan to manage the contract to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.4.4. Subcontract Management. The Contractor shall be responsible for the management and performance of subcontractors during this contract. Contractors may add subcontractors to their team after notification and approval from the Procuring Contracting Officer (PCO) and COR. Cross Teaming shall be permitted.

2.5. REPORTS

2.5.1. Reports and documents delivered by the Contractor in the performance of this contract shall be considered Technical Data as defined in the applicable “Rights in Data” clause (i.e., DFARS clause 252.227-7015). All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the Contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS.

2.5.1.1. Monthly Status Reports (Deliverable 5). The Contractor shall provide monthly reports detailing all work completed within seven (7) calendar days after each end of month. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next two (2) months, those items which required government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency, and all ODC expenses billed for the month. It shall be submitted with a transmittal letter that highlight major events in the reporting period.

The report shall also include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, inventories, and any problems/issues encountered as applicable. The format for the report shall be agreed upon by the Government and Contractor.

2.5.1.2. Quarterly Reports (Deliverable 6). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the COR no later than 15 calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.5.1.3. Final Report (Deliverable 7). The Contractor shall provide a Final Report to the COR. The Contractor shall prepare the Final Report that shall include, but not be limited to, the results of the work performed and completed throughout the life of the contract and list of deliverables provided by the Contractor as part of the requirement. The report shall be submitted to the COR no later than 30 days after the end of the contract.

2.6. OTHER DIRECT COSTS (ODC’S). Shipping/transporting from USAMRIID to storage facility on an as needed basis.

2.7. Maintain Safety, Security, and Biosecurity Standards

2.7.1. General

Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom—no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work. Other personal protective equipment may be required, depending on the tasks to be performed and biosafety level.

In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites. Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety, and biosecurity procedures. Personnel may be required to demonstrate initial and continuous task proficiency with strict adherence to biosafety principles in order to conduct work in BSL-2 through BSL-4. Adherence to the USAMRIID Biosafety Program; Biosafety Plan, standard operating procedures, biocontainment suite specific manuals, biosafety training program and biosafety mentorship program will be ensured through a compliance program. As a part of this compliance program, all personnel are required to self-report any deviation to standard procedures and designated personnel may be required to observe work of others in the suites and document observations and adherence to the biosafety plan. Lack of adherence to any component of the Biosafety Program or lack of skill proficiency will be grounds for revocation of biocontainment access.

Investigators in the laboratories study amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments, and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks.

Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and BSL-4. As described above, approved work in biocontainment suites and using BSAT requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

2.7.2. Security - RESERVED

2.7.3. Security Requirements - RESERVED

2.7.4. Installation Access Requirements - RESERVED

2.7.5. Security Clearance Requirements - RESERVED

2.7.6. Requirements for BPRP Enrollment - RESERVED

2.7.7. Requirements for Escorted Entry to Federal Select Agent Program (FSAP)-Registered Spaces (Visitor) -

RESERVED

2.7.8. Workplace Safety - RESERVED

2.7.9. Foreign Nationals Requirements - RESERVED

2.7.10. Requirements for Controlled Substances PRP (CS-PRP) Enrollment. - RESERVED

2.7.11. Network Security – RESERVED

2.7.12. Safeguarding Information - RESERVED

2.7.13. Physical Security - RESERVED

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 DNA VACCINE STORAGE (GMP)

3.1.1. The Contractor shall store bacterial cell lines at colder than -65C. These cell lines are for hantavirus and alphavirus DNA vaccine plasmid preparation. The conductions shall be in compliance with GMP. (Deliverable 8).

3.1.2. The Contractor shall store DNA vaccine product (vialed plasmids) at colder than -15C. These DNA vaccines are for hantavirus and alphavirus DNA vaccines. The conductions shall be in compliance with GMP. (Deliverable 9).

3.1.3. The Contractor shall ship cell lines or DNA vaccine product to sites requested by USAMRIID.

Documentation shall be in accordance with GMP requirements. (Deliverable 10).

3.1.4. The Contractor shall destroy product when formally requested by USAMRIID. (Deliverable 11).

SECTION 4 DELIVERABLES

4.1. Delivery Address

All deliverables shall be submitted to the COR, TPOC and others as specified by the COR.

4.2. Method of Delivery

Electronic copies shall be delivered using Microsoft Office Suite of tools (i.e., MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

4.3. Shipping

The Contractor shall use appropriate, GLP and/or GMP-compliant refrigerated shipping carriers for drug product shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the Contractor shall use the US Postal Service standard delivery for delivery of all such shipments. The COR must approve the selected shipping method and any exceptions to these requirements.

4.4. Government Acceptance Period

4.4.1. The COR will have ten business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) business days for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

4.4.2. The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

4.5. Deliverable/Delivery Schedule

Item PWS Ref Title Distribution Initial Subsequent

Deliverable 1 1.5.1.

(Attachment 01)

OCI

Certification from sub- Contractors

COR, TPOC

Signed OCI confirmations are due, from each subcontractor, prior to performing any work under the contract.

Deliverable 2 1.5.2.

(Attachment 02) Non-Disclosure

Statement

KO, COR,

TPOC

Signed statements are due, from each employee assigned, prior to performing any work under the contract.

Deliverable 3 2.4.3.2.

Contract

Management Plan

KO, COR,

TPOC

Submitted with proposal

Within 15 days of being updated.

Deliverable 4 2.4.3.3.

Quality Control

Plan

KO, COR,

TPOC

Prior to commencement of services

Within 15 days of being updated.

Deliverable 5 2.5.1.1.

Monthly Status

Reports

COR, TPOC

Within 7 calendar days after end of each month

Deliverable 6 2.5.1.2.

Quarterly Reports

COR, TPOC

15 calendar days from the end date of each quarter (Jun, Sep, Dec, Mar)

Deliverable 7 2.5.1.3. Final Report COR, TPOC 30 calendar days from the end date of the contract

Deliverable 8 3.1.1.

Bacterial cell lines storage

COR, TPOC Life of the contract

Deliverable 9 3.1.2.

DNA vaccine product storage COR, TPOC Life of the contract

Deliverable 10 3.1.3.

Shipment of cell lines or DNA vaccine product

COR, TPOC Life of the contract

Deliverable 11 3.1.4.

Product destruction COR, TPOC Life of the contract

5. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP).

5.1. The Government intends to use a QASP to monitor the quality of the Contractor’s performance. The oversight provided for in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required Contractor Performance Assessment Reporting System (CPARS). The QASP is a living document and may be updated by the Government as necessary. The QASP has been included in the PWS as Attachment 03.

5.2. Performance Evaluation Process

A CPARS evaluation assesses a Contractor's performance and provides a record, both positive and negative, on a given Contractor during a specific period of time. Each evaluation is based on objective data (or measurable, subjective data when objective data are not available) supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, Contractor operations reviews, functional performance evaluations, and earned contract incentives. Completed performance evaluations are used by agency source selections officials and KOs from across the government in making award decisions. The Contractor shall designate a Contractor Representative (CR) and provide this information to the KO within 10 calendar days of award. The CR shall have the authority to comment on the CPARS assessment on behalf of their company and within the timeframes established.

A CPARS assessment shall be completed within 120 calendar days after the end of the performance period or end of contract. The CR has the option to provide comments on the evaluation. The CR has a total of 60 calendar days following the Assessing Officials (AO) evaluation signature date and time to send comments. If the CR sends comments within the first 14 days following the AO’s signature date and the AO or Reviewing Official (RO) closes the evaluation, the evaluation will become available within 1 day. On day 15 following the AO’s evaluation signature date, the evaluation will become available for source selection with or without CR comments and whether or not it has been closed by the AO or RO. If no CR comments have been sent and the evaluation has not been closed, it will be marked as “Pending”. If the CR sends comments at any time prior to 61 days following the AO’s evaluation signature date, those comments will be reflected within 1 day. On day 61 following the AO’s evaluation signature date, the CR will be “locked out” of the evaluation and may no longer send comments.

The CR has the authority to access the Government evaluation; review/comment/return the evaluation to the AO within 60 calendar days after notification of the government’s assessment; request a meeting (in writing) with the government within seven calendar days from receipt of evaluation; and request RO review. The evaluation will become available to source selection officials 15 days following the AO’s evaluation signature date. The evaluation will be available with or without Contractor comments and whether or not it has been closed by the AO or RO. If no Contractor comments have been provided at day 15, the evaluation will be marked as “Pending”. Contractor comments may be provided up to 60 days following the AO evaluation signature date and will be updated on a daily basis. Once the evaluation has been closed by the AO or RO, the “Pending” marking will be removed.

Training for CPARS can be found on the CPARS website: https://cpars.gov/lc.htm. Access to CPARS is coordinated on a contract number to contract number basis by the Focal Point. The Contractor will need to work with the KO to obtain access.

SECTION 6 SPECIAL REQUIREMENT

6.1. PROPRIETARY INFORMATION ASSURANCE AND SECURITY

The Contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

6.2. VISITOR GROUP SECURITY AGREEMENT

Before coming into the USAMRIID facility, the Contractor shall sign a Contractor Visitor Group Security Agreement to protect Government information involved in performance under this contract. The agreement shall outline responsibilities in the following areas: Contractor security supervision; standard practice procedures; access, accountability, storage, and transmission of, and other responsibilities, as required.

SECTION 7 DEFINITIONS AND ACRONYMS

7.1. DEFINITIONS

7.1.1. Change Order. A written order, signed by the contracting officer, directing the Contractor to make a change that the Changes clause authorizes the contracting officer to order without the Contractor’s consent.

7.1.2. Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government.

The term used in this contract refers to the prime.

7.1.3. Contracting Officer (KO). A person with authority to enter, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.4. Contracting Officer’s Representative (COR). An employee of the U.S. government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor if that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.5. Day. Unless otherwise specified, a Day is a Calendar Day

7.1.6. Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

7.1.7. Deliverable. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

7.1.8. Key Personnel. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

7.1.9. Offer. A response to a solicitation that, if accepted, would bind the offeror to perform the resultant contract.

7.1.10. Offeror. An Offeror or Bidder.

7.1.11. Option. A unilateral right in a contract by which, for a specified time, the government may elect to purchase additional supplies or services called for by the contract or may elect to extend the term of the contract.

7.1.12. Organizational Conflict of Interest. Because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage.

7.1.13. Physical Security. Actions that prevent the loss or damage of government property.

7.1.14. Proper Invoice. An invoice that meets the minimum standards specified in FAR 32.905(b).

7.1.15. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of Contractor performance.

7.1.16. Quality Control. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.17. Registered in the System for Award Management (SAM). The Contractor has entered all mandatory information, including the unique entity identifier and the Electronic Funds Transfer indicator (if applicable), the Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of 2006 (See FAR Subpart 4.14), into SAM.

7.1.18. Shall. Denotes the Imperative.

7.1.19. SubContractor. One that enters a contract with a prime Contractor. The government does not have privity of contract with the subcontractor.

7.1.20. Workday. The number of hours per day the Contractor provides services IAW the contract.

7.1.21. Work Week. Monday through Friday, unless specified otherwise.

7.2. ACRONYMS

The acronyms used are listed with in the document, and will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the Contractor.

ACRONYM DESCRIPTION

AO Assessing Official

AR Army Regulation

CAGE Commercial and Government Entity

C&A Certification and Accreditation

COR Contracting Officer’s Representative

CR Contractor Representative

DFARS Defense Federal Acquisition Regulation Supplement

DNA Deoxyribonucleic acid

DoD Department Of Defense

FAR Federal Acquisition Regulation

GMP Good Manufacturing Practices

IAW In Accordance With

KO Contracting Officer

KS Contract Specialist

NDS Non-Disclosure Statement

OCI Organization Conflict of Interest

OMB Office of Management and Budget

PCO Procuring Contracting Officer

PIEE Procurement Integrated Enterprise Environment

PM Program Manager

POC Point Of Contact

PWS Performance Work Statement

QASP Quality Assurance Surveillance Plan

RO Reviewing Official

SAM System for Award Management SBU Sensitive But Unclassified SPM Surveillance and Performance Monitoring

USAMRAA United States Army Medical Research Acquisition Activity

USAMRIID United States Army Medical Research Institute of Infectious Diseases

USAMRMC U.S. Army Medical Research and Materiel Command

VIRO Virology Division

QASP

Quality Assurance Surveillance Plan

DNA VACCINE STORAGE (GMP)

1. Purpose.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

What will be monitored?

How Monitoring will take place?

Who will conduct the monitoring?

How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. Government Roles and Responsibilities

a. Contracting Officer (KO) – The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

b. Contract Specialist (CS) – The CS shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CS shall also assure that the contractor receives impartial, fair, and equitable treatment under the contract.

c. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

d. Contracting Officer’s Technical Representative (COTR). A COTR is a Government employee who is authorized to monitor the contractor’s performance under the contract, serve as technical liaison between the contractor and the COR, and perform other duties specified in this document. COTRs have no authority to change any of the terms or conditions of the contract.

3. Contractor Representatives. The contractor’s identified employee shall serve as the contractor’s Program Manager and Task Manager for the contract.

4. Performance Standards. Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards.

The below Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). If the performance standards are not met in the performance requirement summary the government will document the contractor’s past performance and may terminate the contract in accordance with FAR Clause 52.212-4 (m), Termination for Cause.

Task Indicator Standard Acceptable

Quality Level Method of

Surveillance Incentive

Technical Requirements – Section 3.1.1.

Bacterial cell lines storage colder than -65C under GMP conditions

100% Compliant

100% inspection by the Technical

Representative

Positive Past Performance

Rating

Technical Requirements – Section 3.1.2.

DNA vaccine product storage

(vialed plasmids) colder than -15C under GMP conditions

100% Compliant

100% inspection by the Technical

Representative

Positive Past Performance

Rating

Technical Requirements – Section 3.1.3.

Shipment of cell lines or DNA vaccine product

Ship to sites requested by USAMRIID in compliance with

GMPs

100% Compliant

100% inspection by the Technical

Representative

Positive Past Performance

Rating

Technical Requirements – Section 3.1.4.

Product destruction Destroy product when formally requested by

USAMRIID

100% Compliant

100% inspection by the Technical

Representative

Positive Past Performance

Rating

5. Incentives. The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. Methods of Quality Assurance Surveillance.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's Program Manager and Task Manager when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the CS, shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

a. Direct Observation. Can be performed periodically or through 100% surveillance.

Periodically

b. Periodic Inspection. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.

As requested, or required.

c. 100% Inspection. Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.

Provide reports and documentation as specified in the PWS and the Performance Requirements Summary Matrix above.

d. Progress or status meetings.

Surveillance results may be used as the basis for actions (to include payment deductions) against the Contractor.

In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions.

7. Ratings. Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and…