Attachment 1 PWS-Small_Molecule_Compound_Library_Storage 15 Nov 2021.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. KEY PERSONNEL

10. CONTRACT MANAGEMENT

11. COMPLIANCE DOCUMENTS

12. OTHER TERMS, CONDITIONS, AND PROVISIONS

13. ATTACHMENTS

PERFORMANCE WORK STATEMENT (PWS)

Title: Small Molecule Compound Library Storage

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR)

1. INTRODUCTION

The WRAIR conducts 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.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

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 three Centers of Excellence for Military Psychiatry and Neuroscience Research, Military Infectious Disease Research, and Enabling Capabilities Research;

each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

WRAIR’s Experimental Therapeutics (ET) branch is a drug discovery and development enterprise created to protect military personnel from death, disease, and injury and meet Army and DOD mission requirements. WRAIR-ET has a 75-year legacy of excellence in small molecule drug development, with over 65 Investigational New Drug (IND) applications submitted to the U.S. Food and Drug Administrations (FDA). WRAIR-ET applies its core competencies of medicinal, synthetic, and analytical chemistry as well as clinical pharmacology to all therapeutic areas within the Medical Research and Development Command's portfolio.

Over this rich history of research and drug development, WRAIR-ET has amassed a collection of small molecule compounds that contains approximately 400,000 samples with nearly 300,000 unique chemical structures. This collection include molecules that have been acquired from a variety sources, but many have been synthesized specifically for drug development research conducted at WRAIR and are not available from other sources. In conjunction with this compound library, WRAIR-ET maintains a proprietary database of efficacy and toxicological data from research that has been conduct using these compounds. WRAIR-ET continues to use these data and this compound library in ongoing drug development and discovery efforts.

WRAIR-ET currently operates a contractor-run, repository facility to house biological samples, documents, and chemicals including this library, but due to a reduction in scope the branch no longer has a requirement to maintain a dedicated repository. Therefore, the contents of the repository will be disposed of or relocated to other storage facilities. The purpose of this contract is to store the current compound library, as well as new molecules acquired by WRAIR-ET, and to provide services to allow the use of the compounds by WRAIR researchers and its collaborators.

3. SCOPE

The scope of this work is to provide secure storage of chemical samples under appropriate environmental conditions and to prepare and ship requested amounts of these chemical sample to WRAIR or its collaborators at various CONUS or OCONUS locations. The contractor shall maintain a full inventory of samples on hand that includes amount of material remaining. Approximately 400,000 samples shall be delivered to the contractor at the onset of the award with an additional average of approximately 2,000 new samples per year. The contractor shall distribute approximately 4,500 samples per year.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 1 December 2021 – 30 November 2022 Option period 1 1 December 2022 – 30 November 2023 Option period 2 1 December 2023 – 30 November 2024 Option Period 3 1 December 2024 – 30 November 2025 Option Period 4 1 December 2025 –30 November 2026

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work will be conducted at the contractor’s facility. Contractor’s storage facility shall be located within a distance from WRAIR for which a round trip can be made via ground transportation within a standard work day.

5.1.1. Telecommuting

Not applicable.

5.1.2. Working During Emergency Situations

5.2. Federal Holidays

5.2.1. The contractor shall not be required to perform services on days designated as a Federal Holiday by

Federal Status, Executive Order, Presidential Proclamation or Installation Commander

5.2.2. 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 that services shall not be performed

The following are Federal Holidays:

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

Washington’s Birthday Memorial Day Independence Day Juneteenth

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5.3. Post Closure

5.4. Work Schedule

The contractor shall provide support from 0745 to 1630 Eastern Time.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The objective of this is to provide secure storage of chemical samples under appropriate storage conditions and to delivery required amount of these samples to WRAIR or its collaborators upon request. The vendor shall also receive and in-process additional chemical samples over the course of this contract.

The overall tasks shall be:

• Contracting Initiation and In-processing of Existing Chemical Samples

• Receipt of New Compounds and Chemical Samples

• Storage of Compounds and Chemicals Samples

• Compound Preparation, Shipping and Delivery

6.2. General Requirements

6.2.1. The Contractor shall provide all the necessary personnel, facilities, supplies and resources necessary to perform the requirements listed below.

6.2.2. For the purpose of receipt and storage of compounds, a sample shall be considered any non-separable container that contains one or more chemical compounds. For example, a multi-well plate constructed from a single piece of plastic shall be considered a single sample, but each compound in a multi-well plate with removable inserts would be a unique sample.

6.2.3. For the purposes of preparation of compounds for shipment, a sample shall be considered any individual chemical compound that must be prepared individually for shipment. When an entire container is requested for shipment, each container shall be considered a single sample, regardless of whether the container is separable. For example, if multiple compounds are requested and the Contractor weighs and transfers them into inserts into a multi-well plate for shipment, each compound would be considered a sample, but if a multi-well plate that is already in inventory is requested without any transfer of material, the entire plate, even if the plate has removable inserts, shall be considered a single sample.

6.3. Contractor Compliance Requirements

6.3.1. The contractor shall adhere to and be in compliance with all the most up to date relevant regulations and guidelines, and shall possess the necessary licenses and permits for the operation of the Small Molecule Compound Library Storage and the storage and shipment of compounds and chemical samples. At a minimum the contractor shall meet the following requirements:

a. The contractor shall store compounds according to all applicable federal, state and local regulations.

b. The contractor shall have the capability to ship all materials from the state in which the Small Molecule Compound Library Storage is located to CONUS and OCONUS locations. Use of commercial shipping services is an acceptable means to meet this requirement.

6.4. Contract Initiation and In-processing of Existing Chemical Samples

6.4.1. The contractor shall designate a Project Coordinator to be a primary point of contact to coordinate all steps necessary to receive, in-process, and register WRAIR’s existing collection of chemical samples and to setup any pre-requisites to meet the terms of this PWS.

6.4.2. The contractor shall work with the WRAIR LIMS administrator to determine what data are required from the WRAIR LIMS for initial configuration of the contractor maintained LIMS inventory records. The WRAIR LIMS administrator will provide a text file with the required fields for the full inventory that will be delivered to the contractor.

6.4.3. The contractor shall propose a method for quality control and use that method to assess the accuracy of the inventory records provided by the government for WRAIR’s existing collection of chemical samples that are received. The method must be approved by the COR before receipt of the chemical samples.

6.4.4. The contractor shall receive and in-process WRAIR’s existing collection of chemical samples, which includes approximately 400,000 samples that are in approximately 370,000 individual bottles and 1,000 multi-well plates.

6.4.5. The contractor shall develop file templates for data sharing between WRAIR and the contractors information systems to meet the specification defined in the PWS.

6.4.6. The contractor shall setup the required web-interfaces and LIMS system to meet the requirements of the PWS.

6.5. Receipt of New Compounds and Chemical Samples

6.5.1. The contractor shall provide a web-interface that allows WRAIR researchers to electronically submit all required data for compounds to be added to WRAIR’s collection of chemical samples being stored at the contractor’s facility. The interface shall accept manual entry or upload of files generated by the WRAIR LIMS.

6.5.2. The contractor shall provide shipping of chemicals to the Small Molecule Compound Library

Storage from WRAIR, its partners, or collaborators from various CONUS or OCONUS locations.

6.5.3. Shipping and delivery expenses provided by third party couriers or commercial delivery services shall be on a cost reimbursable basis. The contractor shall be required to provide document of costs in the form of the third party invoices with shipping and delivery receipts.

6.5.4. The contractor shall ensure all shipping conforms to all laws and regulations governing the shipping of hazardous substances and drugs and will provide all required shipping labels and instruction as needed on how to properly package and ship samples to meet laws and regulatory requirements.

6.5.5. Upon receipt of compound or chemical samples, the contractor shall review the accuracy of the submitted records versus what was received and will notify the COR if there are any discrepancies, and upon verification of the COR, take any necessary corrective action in the contractor’s LIMS.

6.5.6. The contractor shall receive and in-process approximately 2,000 new compounds or chemical samples annually. Compounds and chemical samples sent to the Small Molecule Compound Library Storage will be in various forms including but not limited to vials, jars, and plates, and will vary in size from a few milligrams to kilograms, with the majority being less than 100 milligrams.

6.5.7. The contractor shall process receipt of new compounds within three (3) days of arrival at the contractor’s facility.

6.5.8. The contractor shall print and affix a barcode label that matches the barcode in WRAIR LIMS to any sample that does not already have a readable barcode.

6.5.9. The contractor shall be prepared to handle surge capacity of up to 10,000 additional new samples annually. These additional samples shall be above the baseline specified in paragraph 6.5.6 and shall be invoiced against a surge CLIN.

6.6. Storage of Compounds and Chemicals Samples

6.6.1. The contractor shall store and maintain under appropriate storage conditions WRAIR’s existing collection of chemical samples as described above.

6.6.2. The contractor shall store and maintain under appropriate storage conditions new compounds and chemical samples that are received throughout the period of performance of this agreement, as described above.

6.6.3. The contractor shall use a Laboratory Information Management System (LIMS) to maintain relevant, accurate, and current records including, but not limited to, identity, amount on hand, shelf location, shipping history, and sample and container identifiers that cross reference to the WRAIR LIMS for all compounds and chemical samples in stock.

6.6.4. The contractor shall provide updates of inventory records on at least a monthly basis in an open source, machine readable file format that can be used to update the WRAIR LIMS. If feasible, an application programming interface (API) connection will be developed in conjunction with WRAIR’s LIMS administrator to allow direct transfer of updated records between the contractor’s LIMS and the WRAIR LIMS.

6.6.5. The contractor shall cross references newly received samples to other samples of the same compound and include those cross references in the LIMS.

6.6.6. The contractor shall receive returned compounds and chemical samples and cross-reference them to the original sample lot and annotate the samples as returned samples with the LIMS.

6.6.7. The contractor shall store compounds under applicable federal, state, and local regulations.

6.6.8. The contractor shall store the compounds and chemical samples under their individual required storage conditions (for example, including but not limited to, -20 °C, 4 °C, room temperature, light-protected, dry storage with desiccant, storage under inert gas, flammable storage etc.) and monitor the storage conditions to guarantee continuous proper storage.

6.6.9. The contractor shall provide special oversight and distribution control of specified discrete inventory of compounds and chemical samples. Approval from the WRAIR COR shall be required for access or distribution of any discrete inventory.

6.6.10. The contractor shall develop Safety Data Sheets (SDSs) as needed for all samples shipped to the

Small Molecule Compound Library Storage.

6.6.11. Quarterly Inventory Report (Deliverable 1): The contractor shall provide Quarterly Inventory Reports (Deliverable 1) for all compounds and chemical samples in the Small Molecule Compound Library Storage by storage condition (note: this is a separate report from the quarterly progress report).

6.6.12. The contractor shall perform a physical inventory on an annual basis, which confirms the presence of all containers of sample provided by the government, or provide an approved mechanism for sample control and tracking that logs all sample access and container movements.

6.6.13. The contractor shall propose and implement a quality control assessment procedure for identifying compounds that should be disposed of, which includes but is not limited to old and expired samples, polymerized samples, and decomposed samples.

6.6.14. List of compounds and chemical samples and other waste recommended for disposal (Deliverable 2): The contractor shall provide the COR a written list of compounds and chemical samples and other waste recommended for disposal as needed (Deliverable 2). Upon review and approval of the COR, the contractor shall then send those compounds and chemical samples to WRAIR ET Branch for disposal.

6.7. Compound Preparation, Shipping and Delivery

6.7.1. The contractor shall provide a web-based ordering interface that allows WRAIR researchers to view inventory and place orders for samples stored at the contractor’s facility.

6.7.2. The ordering interface shall confirm availability of the requested amounts at the time of order.

6.7.3. The ordering interface shall accept manual ordering processes as well as being able to accept files output from the WRAIR LIMS for automated ordering. If feasible, an API connection will be developed in conjunction with WRAIR’s LIMS administrator to allow direct ordering from the

WRAIR LIMS.

6.7.4. The contractor shall prepare and ship 4,500 compounds and chemical samples annually as requested by the WRAIR- ET to the WRAIR and its partners and collaborators in various CONUS and OCONUS locations. Shipment sample sizes are typically in the 1 mg to 5 g range, though larger amounts may be requested on an as needed basis.

6.7.5. The contractor shall ensure timely preparation and shipment of compound orders. Shipments to locations in the Maryland, D.C., and Virginia areas shall be processed, shipped, AND received within 3 business days. Shipments to any other CONUS or OCONUS locations shall be processed and shipped out within 2 business days.

6.7.6. The contractor shall transfer the requested amount of compound or chemical sample to shipping containers. Amounts delivered shall be within a 10 % coefficient of variance (CV) of the requested amount.

6.7.7. The contractor shall record and provide the actual mass of samples with each shipment to the appropriate level of precision. For samples requested below 5 milligram (< 5 mg) range, the precision must be within 10 %. For samples greater than 5 milligrams (> 5 mg), the contractor shall weigh samples within the specifications of the balance or as directed by the WRAIR.

6.7.8. Balance used for measurement shall be calibrated according to the manufacturer’s specifications and shall have an accuracy of ± 1 % for the mass of compound being requested.

6.7.9. The contractor shall ensure all compound and chemical samples are properly packaged in an appropriate container based on sample size and chemical reactivity.

6.7.10. The contractor shall provide all sample and shipping containers, and any other supplies necessary to ensure the safe shipping and arrival of each package shipped.

6.7.11. The contractor shall provide special handling for heat and/or light sensitive and labile chemicals and drugs. Compounds and chemical samples requiring dry ice shall be sent by express carrier.

6.7.12. The contractor shall ensure all shipping conforms to all laws and regulations governing the shipping of hazardous substances and drugs.

6.7.13. The contractor shall provide paper copies of compound information, Safety Data Sheets and any other required documents with the shipment of samples when needed or requested by the Government.

6.7.14. The contractor shall ensure the shipment is correctly addressed, and the shipments have been received at the correct destination.

6.7.15. The contractor shall document and maintain a record of all orders and shipments in their LIMS and provide machine readable files of shipping records on at least a monthly basis to update the WRAIR

LIMS.

6.7.16. Shipping expenses shall be on a cost reimbursable basis. The contractor shall support their invoices with shipping and delivery receipts.

6.7.17. The contractor shall be prepared to handle surge capacity of up to 10,000 additional ordered samples annually. These additional samples shall be above the baseline specified in paragraph 6.7.4 and shall be invoiced against a surge CLIN.

6.8. Management Reports and Plans

6.8.1. Quarterly Progress Reports (Deliverable 3): Quarterly Reports are the most immediate and direct contact between the Project Manager (PM) and the Contracting Officer’s Representative (COR). The reports provide the means for keeping this Command advised of developments and problems as the contract effort proceeds. The Quarterly Reports also provide a measure against which decisions on release of funding and on requests for supplements are made. A Quarterly Report shall be submitted for each three month period (Jan – Mar, Apr – Jun, Jul – Sep, and Oct – Dec). This requirement includes the three month period preceding both the Annual and Final Reports. The report shall include, at a minimum, a brief description of the work accomplished, work in progress, plans for the next reporting period, GFP information (See Section 11) and any other information pertinent to the contract, either technical or administrative that may affect the performance of the contract.

6.8.2. Final Report (Deliverable 4): A Final Report covering the entire contract term (base year and all option years) shall be submitted citing data in the Annual reports as necessary. The Final Report shall be prepared specifically for this requirement. Quarterly or other interim reports, or journal articles shall not be used in total as any part of the report. Data presentation should be comprehensive in providing a complete record of the accomplishments for the period of the report.

6.8.3. Contractor Performance Assessment Reporting System (CPARS) Concurrence/Non-concurrence (Deliverable 5): A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and 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. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions.

The contractor shall appoint a Contractor Representative (CR) and provide this information to the Contracting Officer (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation.

Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non- concurred with the rating, PPIRS will show the government evaluation as "Contractor Comment Pending Review". The CR has a total of 60 calendar days to concur/non- concur with the assessment. After 60 days, the CR can either concur/non-concur. The CR has the authority to: access the Government evaluation;

review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government's assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website:

https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

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.

DELIVERABLES TABLE

PWS

Ref. Number Title/Description Due

6.6.11

Deliverable 1

Quarterly Inventory Report

Within two (2) weeks after the conclusion of the quarter.

6.6.14 Deliverable 2 List of compounds and chemical samples and other waste recommended for disposal upon request of COR

6.8.1

Deliverable 3

Quarterly Progress Reports The contractor shall provide report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support.

after the conclusion of the quarter.

6.8.2 Deliverable 4 Final Report

To be submitted prior to last invoice

6.8.3

Deliverable 5

Contractor Performance Assessment Reporting System (CPARS) Concurrence/Non-concurrence The contractor shall provide concurrence or non-concurrence with the CPARS assessment.

60 calendar days after Government evaluation

7.1. Technical Reports and Documents

Technical reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable DFAR clause 252.227-7013, Rights in Technical Data-Noncommercial Items. 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 responsibilities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

https://www.cpars.gov/index.htm

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

To be determined upon 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 Acceptable Quality Level Method of Surveillance Incentive

6.5.7

Process receipt of new compounds within three (3) days of arrival

Greater than 95% of samples shall be process and placed inventory within 3 days of receipt by the contractor

Review of compound registration and shipping records

Frequency: Yearly.

Past Performance

6.6.8

Compounds and chemical samples stored under their individual required storage conditions

All compounds shall be stored under the condition designated by the Government

Review of LIMS records

Frequency: Upon completion of initial in processing and yearly

6.7.5

Ensure timely preparation and shipment of compound orders

Greater than 95% of samples shipped to locations in the Maryland, D.C., and Virginia areas shall be received within 3 business days and shipments to any other locations shall be shipped out within 2 business days.

Review of order and shipping order records

Frequency: Yearly.

6.7.6

Transfer the requested amount of compound or chemical sample to shipping containers

Amount of transferred chemical shall be within a 10 % CV from the requested amount for a set of compounds in a single shipment

User Complaints

Frequency: Upon complaint

9. CONTRACT MANAGEMENT

9.1. 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.

9.2. 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 and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

9.3. Contractor Organization

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.

9.4. 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.

9.5. Subcontract management

9.5.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

9.5.2. The contractor is responsible and accountable for subcontractor performance on this contract

9.5.3. The contractor is responsible to manage task distribution to ensure there are no OCIconsiderations

9.5.4. Contractor may add subcontractors to their team after notification and written approval from the KO.

9.5.5. Privy of contract is with the contractor and the subcontractor.

9.6. 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 facilityis granted.

Government computer access will not be approved until a background check is done in accordance with para 16.11.2.a. 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.

10. COMPLIANCE DOCUMENTS

10.1. General Compliance

10.1.1. 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 Development Command (USAMRDC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://MRDC.amedd.army.mil/rodorphrpo.asp.

10.1.2. 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.

10.1.3. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

b) Army Regulation 25-1, Information Technology.

https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN18191_R25_1_FINAL.pdf

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011.

http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

e) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

f) DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

g) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

h) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program https://safe.menlosecurity.com/doc/docview/viewer/docNFA8C4A66FB6A71c869edb585a811044 c42e600ce00efc8b88999964aae13d5b4ccc31c4c9d1f

i) Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990 – currently under revision

j) Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and-

Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

k) Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014.

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/644002m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US Department of Defense and Health and Human Services.

l) College of American Pathologists Inspection Checklists. http://www.cap.org http://www.dtic.mil/whs/directives/corres/dir.html http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf https://safe.menlosecurity.com/doc/docview/viewer/docNFA8C4A66FB6A71c869edb585a811044c42e600ce00efc8b88999964aae13d5b4ccc31c4c9d1f https://safe.menlosecurity.com/doc/docview/viewer/docNFA8C4A66FB6A71c869edb585a811044c42e600ce00efc8b88999964aae13d5b4ccc31c4c9d1f http://www.cms.gov/Regulations-and-http://www.ecfr.gov/cgi-bin/text-http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/644002m.pdf http://www.cap.org/

m) Clinical Laboratory Standards Institute. Standards and Guidesfor Laboratories:

http://clsi.org/standards

n) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

o) National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical

Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

p) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

q) Title 21, CFR Part 11 Electronic Records: Electronic Signature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

r) Title 21, CFR Part 50 Protection of Human Subjects https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showF R=1

s) Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

t) Title 21 CFR Part 56, Institutional Review Boards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

u) Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

v) Title 45 CFR 46, Protection of Human Subjects, April 1, 2014, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#

w) Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_nu mber=1910

x) Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum

Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

y) Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173- 199.pdf

z) Dangerous Goods Regulations of the International Air TransportAssociation.

http://www.iata.org/Pages/default.aspx

aa) Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

10.2. Information Technology Compliance- Not Applicable

10.3. Medical and Laboratory Compliance- Not Applicable

http://clsi.org/standards http://clsi.org/standards http://clsi.org/standards http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showF http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_nu http://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-http://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-http://www.iata.org/Pages/default.aspx http://www.iata.org/Pages/default.aspx http://www.iata.org/Pages/default.aspx http://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-

11. KEY PERSONNEL

11.1. The contractor shall provide a Program Coordinator that has demonstrated past experience with positive performance reviews for coordination of the facilities setup and in-processing of a large compound library with equivalent or greater complexity as what is outlined in the PWS.

12. OTHER TERMS, CONDITIONS, AND PROVISIONS

12.1. Non-Personal Services

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.

12.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

12.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

12.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

Not Applicable for this Award

12.5. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G.

These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating.

These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information.

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities (solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official (contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

12.6. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

12.7. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

DFARS 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. The contractor shall implement National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations.”

12.8. Contractor Identification

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

12.9. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

12.10. Data Rights

The Government will retain rights to all data generated in the course of developing, deploying, training, using and supporting WRAIR or other federal agencies that utilize this contract. The contractor shall adhere to the guidelines described in the Contract Data Requirements List (CDRL), DD form 1423 for reports. (Exhibits A & B).

12.11. Anti-Terrorism and Operational Security

12.11.1. AT Level I Training. N/A

12.11.2. Installation Access. N/A

12.11.3. AT Awareness Training for Contractor Personnel Traveling Overseas. N/A

12.11.4. iWATCH Training. N/A

12.11.5. Army Training Certification Tracking System (ATCTS) registration N/A

12.11.6. OPSEC Standing Operating program. N/A

12.11.7. OPSEC Training. N/A

12.11.8. For IA/IT training. N/A

12.11.9. For Information Assurance (IA)/Information Technology (IT) Certification. N/A

12.11.10. For Contractors Authorized to Accompany the Force. N/A

12.11.11. For Contract Requiring Performance or Delivery in a Foreign Country. N/A

12.11.12. For Contracts That Require Handling or Access to Classified Information. N/A

12.11.13. Threat Awareness Reporting Program (TARP). N/A

12.12. System Security Plan and Associated Plans of Action

12.12.1. The Contractor shall, upon request, provide the government with access to the system security plan(s) (or extracts thereof) and any associated plans of action for each of the Contractor’s tier one level subcontractor(s), vendor(s), and/or supplier(s), and the subcontractor’s tier one level subcontractor(s), vendor(s), and/or supplier(s), who process, store, or transmit covered defense information associated with the execution and performance of this contract. System Security Plan and Associated Plans of Action for a Contractor’s Internal Unclassified Information System [Insert Contract Data Requirements List (CDRL) Data Item Number Block 1 of DD Forum 1423-1].

CDRL for System Security Plan and Associated Plans of Action for a Contractor’s Internal Unclassified Information System is found in Defense Pricing and Contracting Memo, Guidance for Assessing Compliance and Enhancing Protections Required by DFARS Clause 252.204-7012, dated November 6, 2018 (https://www.acg.osd.mil/dpap/pdi/cyber/index.html).

12.13. Identification, Tracking, and Restricted Flow Down of all Covered Defense Information, and for Requesting the Contractor’s Record of Tier 1 Level Subcontractors, Vendors, and/or Suppliers who Receive or Develop Covered Defense Information

12.13.1. Identify all covered defense information associated with the execution and performance of this contract.

At the post-award conference the Contractor and the Government/Program Office shall identify and affirm marking…