ATTACHMENT_1_-_PWS.pdf

PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. KEY PERSONNEL

11. TRAVEL/TEMPORY DUTY (TDY)

12. GOVERNMENT FURNISHED PROPERTY

13. CONTRACT MANAGEMENT

14. COMPLIANCE DOCUMENTS

15. REFERENCE DOCUMENTS

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

PERFORMANCE WORK STATEMENT (PWS)

Title: Anti Parasitic Drug Animal Testing

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Experimental Therapeutics (ET) Branch

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The Experimental Therapeutics (ET) Branch is part of the Walter Reed Army Institute of Research (WRAIR). The mission of the ET Branch is to discover and develop new pharmaceutical agents to protect military members from death, disease, and injury. The ET Branch is the nation’s primary developer of new drugs to prevent and/or treat malaria and leishmaniasis. Collectively, ET engages in drug discovery, drug efficacy and mechanism evaluation, and formal preclinical and clinical development.

More specifically, prophylaxis and treatment of leishmaniasis and malaria are central to the WRAIR infectious disease program. It is essential to innovate, conduct, and sustain primary and secondary Leishmania in vivo imaging rodent drug efficacy models and to innovate, conduct, and sustain in vivo imaging assays for rodent liver stage malaria efficacy testing. This is integral to ET’s drug discovery and development program.

3. SCOPE

This requirement is for specialized services to develop anti-microbial drug screens, test drug candidates, formulate and execute protocols, and analyze data for a host of diseases and biological threats. The contractor shall adhere to all applicable standard operating procedures (SOPs), technical manuals, and laboratory safety in the performance of the following activities:

3.1. Assist in the development of the next generation of anti-microbial drugs, to include anti-malaria and anti-leishmanial drugs.

3.2. Collaborate with the Principal Investigator to manage the in vivo leishmania models of Drug Discovery.

3.3. Manage a highly skilled team to sustain and conduct the Rodent Erythrocytic Malaria Models used for assessing efficacy of potential anti-malarial compounds.

3.4. Conduct the DMPK/ADME Studies for the Leishmania Program.

3.5. Conduct in vivo Toxicity of potential anti-microbial drugs.

3.6. Support anti-microbial related Material Transfer Agreements (MTA), Cooperative Research and

Development Agreements (CRADA), and internal and external grants.

3.7. Act as a Subject Matter Expert (SME) for In Vivo Imaging System (IVIS) Facility and the in vivo assays that require use of the in vivo imaging technology.

3.8. Facilitate data analysis and archiving in the in-house information and inventory system

3.9. Generate technical reports for all animal models for the purposes of internal and external reporting.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period (transition-in inclusive)

02 December 2018 – 01 December 2019

Option period 1 02 December 2019 – 01 December 2020

Option period 2 02 December 2020 – 01 December 2021 Option Period 3 02 December 2021 – 01 December 2022 Option Period 4 (transition-out inclusive)

02 December 2022 – 01 December 2023

5. WORK SCHEDULE AND LOCATION

The main work location is at the Walter Reed Army Institute of Research, Experimental Therapeutics Branch, Department of Drug Discovery at 503 Robert Grant Avenue, Silver Spring, MD 20910. Some activities may require performance off-site and CONUS/OCONUS travel for presentation of data at scientific meetings and conferences.

The contractor’s work day shall be eight (8) hours per day, between the hours of 0745 to 1630 with flexibility based on experimental time points. The lunch period shall not exceed one hour and shall be taken between the hours of 1100 and 1300. Work may be required on weekends due to schedule of protocols and animal monitoring needs. If this is to occur the contractor shall notify the COR in advance to request approval.

5.1. Telecommuting

Telecommuting is situational and requires approval. The contractor shall coordinate the telework schedule with the COR in advance to ensure appropriate contractor coverage. Teleworking may be possible during government announced installation closures and delay.

5.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency.

When any disruption of normal, daily operations occur, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

5.3. Federal Holidays

The contractor shall not work on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander unless preapproved by the COR and deemed necessary to monitor protocols or ongoing experiments (i.e. animal studies, etc.).

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:

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5.4. Post Closure

On-site contractor personnel will not be designated as Mission Essential and will not work during post closures unless preapproved by supervisor and deemed necessary to monitor protocols (i.e. animal studies, etc.). All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The overall objective of this requirement is to assist in the development of the next generation of anti-microbial drugs, to include anti-malaria and anti-Leishmanial drugs. That means performing laboratory experiments that lead to the identification of novel anti-malarial and anti-Leishmanial agents and to understand the mechanism of actions of these agents.

6.2. Task 1 - In vivo Leishmania Models of Drug Discovery

The contractor shall collaborate with the Principal Investigator and serve as the Lead Senior Scientist and Associate Investigator for the in vivo Leishmania models. The contractor shall demonstrate the ability to innovate, conduct testing, and sustain in vivo Leishmania models:

a. The Contractor shall provide expertise of Leishmaniasis drug screens in order to serve as the SME and scientific liaison for internal (WRAIR) and external collaborators.

b. The Contractor shall work as part of the ET Leishmania Research team to develop and perfect a new algorithm for anti-Leishmanial drug testing to ensure a streamlined hit-to-lead process that maximizes timelines.

c. The Contractor shall lead a highly skilled team to conduct, sustain, and develop tiered –gated in vivo Leishmania drug efficacy in vivo screens.

d. The Contractor shall implement the animal protocol titled “Phlebotomus duboscqi saliva and luciferase expressing Leishmania major BALB/c mouse IVIS model, for evaluation of anti-Leishmanial drugs”. The Contractor shall establish a natural infection model that utilizes the in vivo imaging technology for assessing Leishmania drug efficacy in BALB/c mice and Golden Syrian Hamsters.

e. The Contractor shall implement the animal protocol titled the in vivo Leishmania spp. anti-Leishmanial drug screen titled: “Efficacy of new anti-Leishmanial drugs in mice or hamsters infected with Leishmania spp.

parasites.”

f. Based on the biology and course of the Leishmania disease in different species of animals infected with different Leishmania spp., the contractor shall recommend the dosing regimens, the animal strain, a specific animal model, and a specific Leishmania spp.to be used in different scenarios in anti-leishmanial drug discovery to internal (WRAIR) and external collaborators.

g. The Contractor shall innovate, develop, and perform new in vivo models for Leishmania drug efficacy testing.

h. The Contractor shall capture, interpret, and analyze experimental results, identify hit compounds, work through the lead optimization process and help with the final selection of a candidate molecule for drug development.

i. The Contractor shall capture, interpret, and analyze experimental results, as well as prepare and publish peer-reviewed scientific manuscripts on novel in vivo models of rodent Leishmania.

j. The Contractor shall author and publish peer-reviewed scientific manuscripts on efficacy of potential anti-leishmanial compounds in the in vivo models of rodent Leishmania.

k. The Contractor shall make recommendations to the ET Branch and external collaborators about drug screening strategies that include, but are not limited to, establishing appropriate dosing regimens with the purpose of reaching the therapeutic objective of anti-leishmanial drugs.

l. The Contractor shall combine in vivo drug efficacy study results with pharmacokinetic study results obtained in early stages of pre-clinical drug discovery to make recommendations about next steps to be taken in the lead compound optimization process.

m. The Contractor shall follow the biology and course of the Leishmania disease dissemination in different species of animals infected with different Leishmania spp.

n. The Contractor shall participate in face-to face meetings and teleconferences and provide detailed written and/or oral reports to internal (WRAIR) and external collaborators.

o. The Contractor shall document all new and existing in vivo imaging efficacy assays in standard operating procedures (SOPs).

p. The Contractor shall conduct efficacy drug testing to a rigorous scientific standard.

q. The Contractor shall sustain and further develop the primary Lesion Suppression Drug Screen model in mice infected with different Leishmania spp. The contractor shall determine possible anti-leishmanial drug efficacy in 18-20 days post animal infections. The contractor shall ensure quality assurance and quality control (QA/QC) of all samples and data.

r. The contractor shall perform statistical data analysis using specialized software such as GraphPad Prism etc and interpret study results.

s. The contractor shall develop and sustain a secondary drug screen model in BALB/c mice and Golden Syrian Hamsters infected with different Leishmania strains, ensuring quality assurance and quality control (QA/QC) of all samples and data.

t. The contractor shall successfully write new animal protocols for the Institutional Animal Care and Use Committee (IACUC) as needed and shall be responsible for renewing old ones. Furthermore, the contractor shall prepare for protocol submission and defend new protocols in front of IACUC committee.

u. The contractor shall conduct research experiments with the purpose of elucidating the biology and course of the Leishmania disease in different species of animals infected with different Leishmania spp.

v. The contractor shall establish if animal models of Leishmania can predict the efficacy, dose, length and frequency of treatment of potential anti-Leishmanial drugs in humans.

w. The contractor shall prepare and submit protocol amendments to the IACUC committee and coordinate approval efforts to include briefing committee members.

x. The Contractor shall assist grant writing and submission.

y. The Contractor shall provide project updates to Division leadership as needed.

6.3. Task 2 - Sustain and conduct the Rodent Erythrocytic Malaria Models

a. The Contractor shall provide expertise of blood-stage rodent malaria drug screens, including but not limited to the modified Thompson test and Peter’s suppression test, in order to serve as the scientific liaison for internal (WRAIR) and external collaborators.

b. The Contractor shall provide expertise of the modified Thompson test, used to measure survivability, parasite clearance, and drug efficacy in the in vivo models of rodent malaria, in order to serve as Lead Senior Scientist for the ET Branch. The Contractor shall design, implement, and oversee execution of in vivo toxicity studies.

The Contractor shall interface with internal and external collaborators, customize experimental design (e.g.

length and frequency of treatment, route of drug administration, appropriate controls and animal strain), perform data analysis, ensure QA/QC, and author high-quality reports.

c. The Contractor must provide expertise of Malaria in vivo screens to troubleshoot testing and sustain novel in vivo assays designed for rodent drug malaria efficacy testing.

d. The Contractor shall innovate, make changes to existing rodent models of malaria, and use in vivo imaging assays to enhance performance and throughput.

e. The Contractor shall conduct research on how to use the in vivo imaging technology to help comply with the 3 R’s of animal use in research.

f. The Contractor shall establish and validate new primary, secondary, and tertiary biological efficacy models for erythrocytic-stage malaria compound screening.

g. The Contractor shall capture, interpret, and analyze experimental results, identify hit compounds, work through the lead optimization process and help with the final selection of a candidate molecule for drug development.

h. The Contractor shall capture, interpret, and analyze experimental results, as well as prepare and publish peer-reviewed scientific manuscripts.

i. The Contractor shall make recommendations to the ET Branch and external collaborators about drug screening strategies that include, but are not limited to, establishing dosing regimens with the purpose of reaching the therapeutic objective of anti-malarial drugs.

j. The Contractor shall perform statistical data analysis using specialized software and interpret study results.

k. The Contractor shall demonstrate mastery of IVIS technology to perform weekly analysis of malaria study experimental results using Living Image software and send appropriate reports to PIs and Division leadership.

l. The Contractor shall participate in face-to face meetings and teleconferences and will give detailed written and/or oral reports for internal (WRAIR) and external collaborators.

m. The Contractor shall author and publish scientific manuscripts on in vivo efficacy assay results in prestigious peer reviewed journals.

n. The Contractor shall assist with grant writing and submission processes.

o. The Contractor shall provide project updates to Division leadership as needed.

p. The Contractor shall represent the ET Branch Malaria Program at national and international events that focus on Malaria disease and drug discovery. The Contractor shall prepare and present oral and/or poster presentations at national and international meetings and conferences.

6.4. Task 3 - DMPK/ADME Studies for the Leishmania Program.

a. The Contractor shall provide expertise of drug metabolism pharmacokinetic (DMPK) studies in order to design, implement, and lead a highly skilled team to execute DMPK studies with the purpose of determining PK parameters and characterize absorption, distribution, metabolism, and excretion of potential anti-leishmanial drugs in plasma.

b. The Contractor shall analyze experimental PK and ADME data. The Contractor shall apply knowledge about multiple dosing as well as one and/or multiple compartment models to design and interpret PK study results.

c. The Contractor shall combine in vivo drug efficacy study results with pharmacokinetic study results obtained in early stages of pre-clinical drug discovery to make recommendations about next steps in the lead compound optimization process.

d. The Contractor shall develop and validate novel mouse and hamster skin PK studies.

e. The Contractor shall proficiently use the Phoenix WinNonlin Software.

f. The Contractor shall conduct mouse and hamster skin drug accumulation studies.

g. The Contractor shall troubleshoot and sustain PK rodent malaria studies.

6.5. Task 4 - In vivo Toxicity and Other Studies

a. In collaboration with a Principal Investigator, the contractor shall design, implement, and oversee the execution of in vivo toxicity studies. The Contractor shall determine drug regimens to be tested in toxicity studies with the purpose of assessing acute and long-term toxicity of drug candidates. Assess maximum tolerated dose (MTD) and minimum efficacious dose (MED). Use proceeding data to design in vivo efficacy screens that comply with the regulatory use of animals in research.

b. The contractor shall modify and optimize existing in vivo models to reflect new findings of the ongoing scientific research that is conducted inside and outside WRAIR with the purpose of keeping the in vivo screens functional and up to date.

c. The contractor shall perform statistical data analysis using specialized software and interpret study results.

d. The contractor shall assist with grant writing and submission.

e. The contractor shall prepare and deliver detailed oral presentations.

6.6. Task 5 - Support with Material Transfer Agreement (MTA), Cooperative Research and Development

Agreement (CRADA), grants, manuscripts, and budgets

a. The contractor shall assist with the preparation of MTAs and CRADAs. Furthermore, the contractor shall customize and establish an experimental design (i.e. length of treatment, route of drug administration, appropriate controls, using the right animal strain etc.) based on the needs and goals of different internal and external collaborators.

b. The contractor shall assist with creating detailed budgets appropriate for specific experimental designs for external and internal collaborators for Leishmania and malaria in vivo studies to be included in MTA’s, CRADA’s, and grants.

c. The contractor shall provide ET collaborators with weekly, monthly, and final reports as needed.

d. The contractor shall prepare and submit quarterly and final reports for Government and non-Government funding sources as needed with prior approval from the COR. The contractor shall participate in all quarterly and final report teleconferences and face-to-face meetings. Prepare and deliver detailed oral presentations.

e. The contractor shall assist with grant writing and assist Government Representatives ensure that grant deliverables and funding are within the appropriate scope, budget, and schedule.

f. The contractor shall draft and submit manuscripts to peer reviewed journals after review and authorization for publication by a Government Representative.

g. The contractor shall prepare and deliver detailed oral presentations in WRAIR Project Review Meetings.

h. The contractor shall prepare and present poster and/or oral presentations at national and international meetings and conferences.

6.7. Task 6 - IVIS Facility and the in vivo assays requiring use of the in vivo imaging technology.

a. The contractor shall provide technical expertise for in vivo assays and animal use:

b. The contractor shall provide subject matter expertise to manage the IVIS Facility.

c. The contractor shall interface with WRAIR medical maintenance staff to facilitate repairs to in vivo imaging equipment. Serve as technical consultant to the laboratory manager regarding: laboratory duties, resources, animal orders, inventories, and safety issues

d. The contractor shall conduct instrument troubleshooting on two existing Perkin Elmer Spectrum In vivo Imaging System (IVIS) machines.

e. The contractor shall collect, analyze, and archive data from the imaging facility.

f. The contractor shall provide quality control of daily drug preparation before drugs are administered to animals.

g. The contractor shall establish and maintain/supervise schedules to ensure experimental protocols are fully manned to include weekends and holidays.

h. The contractor shall perform experimental IVIS protocols in case of personnel absence.

i. The contractor shall prepare and provide required records and assurances for all Institutional Animal Care and Use Committee documents (IACUC) (e.g. protocols, amendments, and reports) prior to approval of those documents

j. In collaboration with the Principal Investigator, the contractor shall monitor all animal care and use activities performed under IACUC-approved animal protocols to insure compliance with the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) regulations.

k. The contractor shall provide technical expertise for all activities performed by research personnel on the animals approved under IACUC protocols.

l. The contractor shall ensure quality assurance and quality control for all data generated

m. The contractor shall coordinate with laboratory managers to assure sufficient training for all individuals working under protocols in collaboration with the Principal Investigator.

n. The contractor shall ensure that the appropriate Personal Protective Equipment (PPE) is utilized, and ensure that the appropriate safety and occupational health rules, regulations and procedures developed by WRAIR are observed.

o. The contractor shall complete all required animal handler training as a means of assuring management is properly advised on institutional expectations for animal care and use.

p. The contractor shall attend safety training relative to the position and report any infractions of safety procedures to the facility Safety Officer.

6.8. Task 7 - Data analysis and archiving in the in-house information and inventory system

a. The contractor shall establish and sustain a protocol for transferring IVIS Malaria data to the lab information and inventory system.

b. The contractor shall establish and sustain a protocol for transferring IVIS Leishmania data to the lab information and inventory system.

c. The contractor shall establish and sustain a protocol for archiving ET animal use protocols and in vivo data in the lab information and inventory system.

d. The contractor shall perform statistical analysis. Troubleshoot all problems that might arise and answer questions before, during, and after a study has ended. Participate in teleconferences. Set and meet deadlines, perform QA/QCs, and ensure experiments are run in timely manner.

6.9. Task 8 - Luciferase expression experiments -

a. The contractor shall conduct Luciferase expression experiments

b. The contractor shall establish and validate a possible BALB/c mouse/ L. tropica, L. panamensis and L.

braziliensis screen. Benchmark known antileishmanial compounds.

c. The contractor shall establish a limited dilution analysis assay protocol with the purpose of determining the correlation between parasite loads vs. luciferase expression over the course of disease progression.

6.10. Task 9 - Troubleshoot Testing –

a. The contractor shall perform troubleshoot testing and help sustain novel in vivo imaging assays for rodent drug malaria efficacy testing

b. The contractor shall troubleshoot and sustain existing rodent malaria in vivo imaging drug efficacy assays.

c. The contractor shall innovate changes to existing rodent in vivo imaging assays to enhance performance and throughput for all current and future therapeutic areas in collaboration with the Principal Investigator.

6.11. Task 10 - Technical Reports – All technical reports produced from the performance of the work must exhibit a level of complexity of analysis and understanding at the post-doctoral level. The contractor shall produce the following technical reports:

a. Generate in vivo imaging malaria efficacy data and perform data analysis (Deliverable 1).

b. Draft in vivo imaging malaria efficacy formal reports (Deliverable 2).

c. Final in vivo efficacy malaria data for the lab information and inventory system (Deliverable 3)

d. Generate in vivo efficacy Leishmania data and perform data analysis (Deliverable 4).

e. Draft in vivo imaging Leishmania formal reports (Deliverable 5).

f. Final in vivo imaging Leishmania data to the lab information and inventory system (Deliverable 6).

g. Final project report/presentation of the conclusions of the project (Deliverable 7)

6.12. Task 11 - Monthly Progress Updates

The contractor shall provide a Monthly written and oral report detailing all work performed in all tasks and any issues encountered (Deliverable 8).

6.13. Task 12 - Annual Status Report – On a yearly basis, the contractor shall provide a report which outlines the status of all project milestones including the following (Deliverable 9):

a. Experimental designs before initiating the task performance

b. Performance Requirements for the Reporting Period and status of those requirements

c. Problem Areas encountered and appropriate resolution;

d. Level of Effort

e. Other Relevant Issues: Any other detail necessary to adequately assess performance for the quarter will be reviewed and input will be shared with the contractor to the extent required to resolve any outstanding issues.

f. Mitigation plan to resolve issues identified.

6.14. Task 13 - Contract Manpower Reporting Application (CMRA) (Deliverable 10).

This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

6.15. CDRLs may be a part of this procurement.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA. The Product Service Code (PSC) is AJ57.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

http://www.ecmra.mil/ http://www.ecmra.mil/

DELIVERABLES TABLE

PWS

Ref. Number Title/Description Due

6.11.a Deliverable 1 In vivo imaging malaria efficacy data and data analysis

Within 2 weeks of request by the COR

6.11.b Deliverable 2 Draft In vivo imaging malaria efficacy reports

Within 1 week of request by the COR

6.11.c Deliverable 3 Final In vivo imaging malaria efficacy reports

Yearly, at least 10 days before the end of the Period of Performance

6.11.d Deliverable 4 In vivo imaging leishmania efficacy data and data analysis

Within in 2 weeks of request by the COR

6.11.e Deliverable 5 Draft In vivo imaging leishmania efficacy reports

Within 2 weeks of request by the COR

6.11.f Deliverable 6 Final In vivo imaging leishmania efficacy reports

Yearly, at least 10 days before the end of the Period of Performance

6.11.g Deliverable 7 Final project report/presentation Yearly, at least 10 days before the end of the Period of Performance

6.12 Deliverable 8 Monthly Progress Reports Monthly by COB on the 1st of the next month

6.13 Deliverable 9 Annual Status Report Yearly, at least 10 days before the end of the period of performance

6.14 Deliverable 10 Contract Manpower Reporting

Application

By October 31 or on the last day of contract performance – whichever is first.

9.1 Deliverable 11 Transition In Plan Within 1 week from the contract start date

9.2 Deliverable 12 Transition Out Plan At least 30 days before the end of the contract

11.2 Deliverable 13 Travel Trip Report Within 30 days after trip is complete

14.1.21 4.1.2

Deliverable 14 OSHA 300A 1 February of each year.

16.12 Deliverable 15 Sexual Assault or Sexual

Harassment Reporting

Conditional Deliverable due only in the event of an incident. The contractor shall immediately (within 24 hours) report an incident of sexual assault or sexual harassment to the COR.

16.12 Deliverable 16 Sexual Assault and Harassment

Training Completion Reporting

60 days after contractor personnel begin performance under this contract, and annually thereafter.

16.11.1

Deliverable 17 Threat Awareness Reporting Program

60 days after contractor personnel begin performance under this contract, and annually thereafter.

16.13 Deliverable 18 Health Insurance Portability and

Accountability Act (HIPAA) Training

Within 30 days after contract award, and then annually thereafter for the remainder of the contract.

Attach ment 7

Deliverable 19 Signed Covered Employee Participation Agreement

Prior to performance beginning on the contract

16.17 Deliverable 20 OSHA Within 30 days after contract award

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data. 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 and under this contract.

7.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

TBD after award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

PWS

Ref.

Performance Objective

Performance Standard

Acceptable Quality Level

Performance Measurement Incentive

6.1- 6.3, 6.6- 6.11

Perform IVIS protocols

Completion of all assigned protocols

95% of tasks shall be satisfactorily completed. Tasks completed unsatisfactorily shall be reworked.

99% surveillance

Frequency: Review throughout completion of each protocol

Positive Past Performance Evaluation

6.2- 6.3, 6.7

Technical consulting on in vivo assays and animal use

Ensure availability of all screens to ET customers

No scheduling conflicts with other screening programs

Frequency: At each customer request

Positive Past Performance Evalulation

6.1- 6.2, 6.4, 6.6, 6.8- 6.11

Develop and sustain in vivo Leishmania models

Timely completion task

No avoidable delays of more than 1 week

Frequency:

Monthly Progress Reports

Positive Past Performance Evaluation

6.1, 6.3, 6.7, 6.8, 6.10, 6.11

Generate IVIS- Malaria data and perform data analysis

Satisfactory completion of experiments

95% of experiments shall be satisfactorily completed. Experiments completed unsatisfactorily shall be reworked.

Reports

Positive Past Performance Evaluation

6.11.e , 6.3.l Draft IVIS-malaria formal reports

Timely delivery of report

Delivery of reports within 1 week of request.

Frequency: At due date for each report

Positive Past Performance Evaluation

6.8.a Format IVIS- Malaria data for the chemical information system

Timely upload of historical data to information and inventory system

95% of data uploaded within 3 months of system being operational

Reports

Positive Past Performance Evaluation

PWS

Ref.

Performance Objective

Performance Standard

Acceptable Quality Level

Performance Measurement Incentive

6.2.n, 6.11.e

Draft IVIS- Leishmania formal reports

Timely delivery of report

Reports delivered within 2 weeks of request.

Frequency: At due date for each report

Positive Past

16.11 .4 iWATCH Training - Contractor provides iWATCH training to all personnel within 30 DACA

Sum of all contractor personnel who have completed iWATCH training within 30 DACA

>90%

Review of Training report from the contractor.

Positive Past

Installation Access - Contractor follows installation access procedures.

Sum of all incidents in which contractor personnel did not follow installation access procedures

< 1 incident per month

Direct observation by COR and installation security.

Positive Past

OPSEC SOP –

Submit OPSEC SOP that meets minimum quality standards.

Number of calendar days after contract award that the contractor submits the OPSEC SOP to the COR

< 90 calendar days after contract award

COR receipt of

OPSEC SOP

Information Assurance Training – Personnel are trained in accordance with DoD and Army policy

Number of calendar days after contract award in which the contractor submits training certifications for all personnel

< 30 calendar days

COR receipt of all certifications

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan (Optional)

The Contractor shall provide a plan for 30 days of incoming transition. The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall develop and deliver a Transition-in Plan (Deliverable 11). This transition plan shall include, but is not limited to the following items as applicable:

a. Coordination with Government representatives,

b. Review, evaluation and transition of current support services,

c. Transition of historic data to new Contractor system (if applicable),

d. Government-approved training and certification process,

e. Transfer of hardware warranties and software licenses (if applicable),

f. Transfer of all System/Tool documentation to include, at a minimum: user manuals, system administration manuals, training materials, disaster recovery manual, requirements traceability matrix, configuration control documents and all other documents required to operate, maintain and administer systems and tools (if applicable),

g. Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches (if applicable),

h. Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

i. Distribution of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc. (if applicable),

j. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance,

k. Applicable WRAIR briefing and personnel in-processing procedures,

l. Coordinate with the Government to account for government keys, ID/access cards, and security codes.

9.2. Outgoing Transition Plan

The Contractor shall develop and deliver an outgoing transition plan (Deliverable 12) for 30 days of outgoing transition for transitioning work from an active award to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required documents, metrics and statistics. This transition plan shall include, but is not limited to:

a. Coordination with Government representatives,

b. Review, evaluation and transition of current support services,

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process,

e. Transfer of hardware warranties and software licenses (if applicable),

f. Transfer of all necessary business and/or technical documentation including laboratory notebooks,

g. Transfer of compiled and uncompiled source code, to include all versions, maintenance updates and patches

(if applicable),

h. Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

i. Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

j. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and

GFE inventory management assistance.

k. Applicable WRAIR debriefing and personnel out-processing procedures.

l. Turn-in of all government keys, ID/access cards, and security codes.

10. KEY PERSONNEL

The contractor shall provide Key Personnel in accordance with the minimum requirements listed within the Key Personnel table.

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced within 30 days.

KEY PERSONNEL TABLE

Key Personnel Position Minimum Requirements Senior Biological Scientist Knowledge and experience in biochemistry, molecular biology, or cell biology working with both malaria and leishmania in the antiparasitic drug discovery field. Demonstrated knowledge in the field as evidenced by peer-reviewed publications in the field of both leishmania/malaria and drug

11. TRAVEL/TEMPORY DUTY (TDY)

All CONUS/OCONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the KO and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures.

11.1. Travel Arrangements

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to the scheduled CONUS/OCONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of Identification before the Contractor is authorized to travel either CONUS or OCONUS. Estimated travel is indicated below:

Period Travel Destination Round Trip (Y/N) # of Trips # of People # of Days Base Scientific Conferences

(CONUS/OCONUS)

Y 2 1 3

11.2. Travel Claim Procedures, Approval, and Reimbursement

The Contractor shall submit an estimate for travel to COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost. The contractor shall provide a Travel Trip Report (Deliverable 13) following each trip.

The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS. The Contractor shall provide a trip report to include costs associated with the travel to the COR within ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by the KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.

11.3. DOD Contractor Foreign Travel / OCONUS

Approval of Foreign Travel. Foreign travel under this contract is defined as any travel outside of the continental United States and its territories and possessions. The cost of foreign travel is allowable only when specific written approval of the Contracting Officer is obtained prior to the commencement of the travel. This is a requirement for all DoD contractors traveling on official DoD business.

11.3.1. The following requirements will be accomplished by the contractor(s) prior to foreign travel on approval of the Contracting Officer. Allow 90 days for completion of training requirements and approval of the application process. Detailed information can be found on the MRMC website:https://mrmc.amedd.army.mil/index.cfm?pageid=mrmc_resources.oconus.

Select all the links under “Contractor Travel Requirements” and comply with the instructions.

Consult the DoD Foreign Clearance Guide https://www.fcg.pentagon.mil

11.3.2. Mandatory training and minimum requirements must be met and a copy provided to the

COR and the Contracting Officer 15 days prior to scheduled departure.

discovery.

https://www.fcg.pentagon.mil/

11.3.3. Costs incurred by contractor personnel on official company business, whether foreign travel and/or domestic/local travel, are allowable subject to the limitations in the Federal Acquisition Regulation (FAR clause 52.216 - 7 Allowable Cost and Payment); incorporated into this contract

11.3.4. MANDATORY TRAINING – OFFICIAL GOVERNMENT TRAVEL

a) Anti-Terrorism Level 1 (valid for one year)

b) SERE 100 (valid for two years)

c) PRO - File

d) Human Rights, SOUTHCOM travel only (valid for one year)

e) US Forces Korea, Korea travel only (valid for one year

f) Area of responsibility briefing completed within three months of travel.

g) PACOM travel; verification that PACOM’s Travel Tracker/Individual Antiterrorism Plan

(TT/IATP) has been completed

h) AFRICOM travel; verification that AFRICOM’S Theater Information Management

System (TIMS) or Statement of Preparedness Document (when TIMS is not available), has been completed.

i) USFK Form 700-19A-R-E

j) US-ROK SOFA IAW FAR 25.8 and USFK Regulation 700-19.

11.3.5. TRAINING LINKS

Anti-Terrorism Level 1-https://atlevel1.dtic.mil/at/.

SERE 100 -https://jko.ifcom.mil PRO-File –https://prmsglobal.prms.af.mil/prmsconv/profile/survey/survey.aspx Human Rights -https://www.americasnet.org.

US Forces Korea -https://www.usfk.mil

12. GOVERNMENT FURNISHED PROPERTY

The Government will provide the contractor with on-site laboratory space, specimens, software, and equipment needed to perform the work.

Government Furnished Property includes: WRAIR network laptops and docking stations. Government provided Laptops will be profiled for WRAIR network access, will be CAC enabled, and will have VPN access.

Government Furnished Information/System Access includes: The Government will provide the contractor with WRAIR Network access to the shared drives as required; and the SharePoint collaboration site. The Government will provide any and all current local templates, SOPs, and policies.

Equipment issued at time of contract award will be annotated in a separate document. The Contractor shall maintain a detailed inventory accounting system for Government Furnished Equipment. The inventory accounting system must specify, as a minimum: product description (make, model), Government tag number, date of receipt, name of recipient, location of receipt, current location, and contract/order number under which the equipment is being used. The Contractor shall attach any updates in the inventory report to the Monthly Progress Report. The Contractor’s inventory listing must be available for Government review within one business day of COR request.

12.1. Return of Government Furnished Equipment

The contractor shall return CACs, WRAIR Picture ID Card, keys, and key fobs for employees no longer supporting the contract and/or on contract expiration. Specifically, the contractor shall, within two business days of employee no longer supporting the contract and/or on contract expiration, return:

a) CACs to WRAIR Security office;

b) WAIR Picture ID Card to WRAIR Security office;

c) Keys to the WRAIR key custodian; and

d) Key Fobs to the WRAIR key custodian.

If the contractor does not returned items a-d within 2 business days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

http://www.americasnet.org/ http://www.usfk.mil/

13. CONTRACT MANAGEMENT

13.1. 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.

Only the KO has the authority to enact changes to this award.

13.2. Contractor Vacant Positions

The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

13.3. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. A background investigation must be completed in its entirety before unescorted access to the facility is granted.

Government computer access will not be approved until a background check is done in accordance with para 18.9.

Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

14. COMPLIANCE DOCUMENTS

14.1. General Compliance

14.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

14.1.2. Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and health Administration Standard Number 1904.32.

The contractor shall deliver the 300A by February 1 of each year.

14.1.3. DoD Compliance Documents

A complete list of Department of Defense compliance…