DRAFT PWS ESKAPEE Pathogens WRAIR.docx

PERFORMANCE WORK STATEMENT (PWS)

Title: Development of Monoclonal Antibodies Against ESKAPEE Pathogens

Requiring Activity Name: Wound Infection Department of Bacterial Diseases Branch (BDB) at Walter Reed Army Institute of Research (WRAIR)

1. INTRODUCTION

The Walter Reed Army Institute of Research (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.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the WRAIR 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 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 Wound Infections Department (WID) within the Bacterial Diseases Branch (BDB) at WRAIR conducts research to eradicate combat-related wound infections. WID conducts requirements-driven programmatic research using a multi-disciplinary approaches to characterize wound pathogenesis and develop novel antibacterial countermeasures for the wound infections that threaten our Service Members. These bacterial infections are caused by seven primary pathogens Enterococcus species, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and Escherichia coli (ESKAPEE). These bacterial species are found worldwide and will always be a threat to Wounded Warriors because of the propensity of these species to be antibiotic resistant and cause infection.

3. SCOPE

This Performance Work Statement (PWS) defines the procurement of the technical expertise and support services to develop antibodies against the ESKAPEE pathogens in support of the WID, BDB, WRAIR. The contractor shall secure the provisions necessary to meet WID objectives and perform the tasks described in this PWS. To meet the objectives, the contractor shall provide antibodies against protein targets found on the surface of ESKAPEE pathogens for research and testing in WRAIR’s in vitro assays and animal models of infection.

4. PERIOD OF PERFORMANCE

This contract is for one (1) twelve (12) months Base Period and four (4) twelve (12) month option periods.

The periods of performance for this contract are as follows:

5. WORK SCHEDULE AND LOCATION

There is no on-site work to be done. All laboratory processing shall be performed by the contractor.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

To create and provide ESKAPEE pathogen antibodies via various purification methods and characterization for research and testing in animal models of infection.

6.2. Specific Tasks / Requirements

6.2.1. The Contractor will receive humanized mice for the injection of antigens or will inject BALB/c mice with target antigens provided by WRAIR.

6.2.2. The Contractor shall generate a hybridoma library with B-cells isolated from mice with human fusion cells to match the humanized mice or with standard immortalized cells for BALB/c mice.

6.2.3. The Contractor will screen the hybridoma library for supernatants and clones positive for the target antigen via ELISA.

6.2.4. The Contractor will subclone positive clones to ensure immortalization and retest supernatants for reactivity against the target antigen.

6.2.5. The Contractor will freeze back and store positive subclones from the hybridoma library for future analysis and future monoclonal antibody development (Deliverable 1)

6.2.6. The Contractor will provide WRAIR with positive supernatants or micro-purified antibodies to be tested by ELISA to identify subclones that interact with the native bacterial surface (Deliverable 2)

6.2.7. The Contractor shall create the monoclonal antibodies identified by WRAIR and the Contractor to be made from the hybridoma library against the target antigens from a given ESKAPEE pathogen. The amount should be in sufficient quantity (milligram quantities) for WRAIR to conduct in vivo and in vitro research, should be purified using an IgG or like column, and stored in sterile PBS or like buffer. Sodium azide will not be used as these antibodies could be tested in animal models. . The Contractor will validate the purified antibodies react to the target antigen by ELISA and store the subclone from which the antibody was derived (Deliverable 3).

6.2.8. The Contractor shall provide monoclonal antibodies made against ESKAPEE pathogen antigens to the WRAIR for additional testing. (Deliverable 4).

6.2.9. The Contractor shall prepare and provide an analysis report to WRAIR upon completion of the purification of each antibody. (Deliverable 5).

6.2.10 The Contractor shall sequence and provide antibody class and subclass when best antibody for each antigen is determined (Deliverable 6).

6.3. Management Reports and Plans

Monthly Financial Tracking Report (Deliverable 7). The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 45 days after contract award and monthly thereafter.

Monthly Report (Deliverable 8). The contractor shall provide a monthly report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments in support of all tasks.

Quality Control Plan (Deliverable 9). The contractor shall provide a draft Quality Control Plan (QCP) no later than (NLT) 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

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.

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 September 01 of each calendar year, beginning with 2021. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

Contractor Performance Assessment Reporting System (CPARS). 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 (Deliverable 11). 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

The Contractor shall prepare and provide an analysis report to WRAIR upon completion of the purification of the antibodies. Sequencing and characterization of the antibodies Upon purification of each antibody

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

15th day of each month for the preceding month

The contractor shall complete and deliver the CMRA.

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

The contractor shall provide concurrence or non-concurrence with the CPARS assessment.

60 calendar days after Government evaluation

The contractor shall provide a Transition-In Plan Draft to be submitted with proposal

The contractor shall provide a Transition-Out Plan NLT 14 days prior to contract expiration.

7.1. 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.

7.2. 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

Meets: 95 - 99.99%.

Does Not Meet: <95% Monitored by the COR

Frequency:

Every 6 months Past Performance

Meets: 95 - 99.99%.

Does Not Meet: <95% Inspected by the COR

Frequency:

At request of COR Past Performance

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan

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 8). 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,

d. Government-approved training and certification process,

e. Transfer of hardware warranties and software licenses,

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,

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

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.,

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 9) for 14 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,

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. TRAVEL/TEMPORY DUTY (TDY)

Not Applicable for this requirement.

11. GOVERNMENT FURNISHED PROPERTY

Not Applicable for this requirement.

12. CONTRACT MANAGEMENT

12.1. 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.

12.2. 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.

12.3. 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.

13. COMPLIANCE DOCUMENTS

13.1. General Compliance

13.1.1. 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 (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.

13.1.2. 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 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. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology. http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

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 http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

13.2. Research Involving Animals

The Animal Care and Use Review Office (ACURO), a component of the USAMRDC ORP, must review and approve all animal use prior to the start of working with animals. Contractors must submit the institutional animal use protocol, Institutional Animal Care and Use Committee (IACUC) approval of that protocol, and a version of the animal use appendix titled “Research Involving Animals.” For guidance on which version of the appendix to use, as well as links to both, visit the ACURO website at http://mrdc.amedd.army.mil/index.cfm?pageid=Research_Protections.acuro_Animalappendix. Allow 2 to 3 months for regulatory review and approval processes for animal studies. For additional information, send questions via email to ACURO (USArmy.Detrick.MEDCOM-USAMRDC.Other.ACURO@mail.mil).

13.3. Medical and Laboratory Compliance

13.3.1. Research Integrity and Misconduct

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

13.3.2. Pathology Inspection

College of American Pathologists Inspection Checklists. http://www.cap.org

13.3.3. Laboratory Requirements

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

13.3.4. Institutional Review Boards

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

13.3.5. Investigational Device Exemptions

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

13.3.6. Bloodborne Pathogens

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_number=1910

13.3.7. Transportation of Materials Containing Certain Etiologic Agents 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

13.3.8. Category B Infectious Substances

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

13.3.9. Dangerous Goods Regulations of the International Air Transport Association Dangerous Goods Regulations of the International Air Transport Association.

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

14. OTHER TERMS, CONDITIONS, AND PROVISIONS

14.1. 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.

14.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

14.3. Inherently Governmental Functions

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

14.4. 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.

14.5. 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.

15. ATTACHMENTS

Attachment 1 – Organizational Conflict of Interest

ATTACHMENT 1: ORGANIZATIONAL CONFLICT OF INTEREST

Walter Reed Army Institute of Research (WRAIR) Acquisition Operational Support

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 (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States Medical Research Directorate – Georgia (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. This 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 CCI 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 task order. Contractors may submit a proposal for task orders in either of the OCI categories.

WRAIR will administer this clause for purposes of award eligibility for each solicitation as follows:

The offeror shall provide a listing of all contracts performed for the WRAIR and any enterprise laboratories (USAMRD-G, USAMRD-A, and AFRIMS) as well as with other MRDC laboratories (i.e. U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), U.S. Army Medical Materiel Development Activity (USAMMDA), the Telemedicine and Advanced Technology Research Center (TATRC) or MRDC) in the last three (3) years. A single-category Offeror/Contractor wishing to submit an offer in the other category, or any Offeror/Contractor which now provides or previously has provided support in both categories, must include the following as part of its offer:

· Perform a comparative analysis of the potential new work against all current and previous work performed in support of WRAIR in any category. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the Contractor is required, unless the Contracting Officer specifically requests an OCI mitigation Plan.

· If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the Contractor shall also submit an OCI Mitigation Plan with its proposal.

Inclusion of the comparative analysis and OCI Mitigation Plan will not be counted against any offer page limitations otherwise stated in the solicitation.

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

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification at the end of this clause with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to tasking any such party under this contract. The Contractor shall appropriately modify and include this clause, including this paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

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

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

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

· Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have Unequal Access to Information? Would award to the Offeror result in the Offeror having the opportunity to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract? Specifically, will the Offeror/Contractor have access to any of the following information:

· Budget(s), or Budget Information?

· Acquisition Sensitive Information related to the procurement process to include, but not limited to Acquisition Plans, Requirements, Statements of Work, or Evaluation Criteria?

· Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have “impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

· Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself?

· Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

· Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have access to third party proprietary information including but not limited to third party Intellectual Property, financial data, or future plans?

The Offeror/Contractor hereby certifies to the best of its knowledge its OCI status below:

(Offeror: Choose one of the following two statements. Indicate which one applies by placing an X in the box to the left of the statement.)

□ No real or perceived OCI, as defined in FAR 2.1 and discussed in FAR 9.5, will result from an award of the proposed work (there are no ‘Yes’ responses to the questions above).

□ A real or apparent OCI may exist as a result of an award and therefore an appropriate OCI Mitigation Plan is attached (Offeror shall include an appropriate OCI Mitigation Plan, as required by this clause, with its quote to the Contracting Officer).

Upon award the Contractor agrees that it will provide timely OCI training to all employees and subcontractor employees working on this effort, which will include emphasis on how work performed by Contractor employees (either prime Contractor, subcontractor, or other teaming partners) under one WRAIR OCI category can exclude the Contractor as well as its teaming partners from performing related tasks under a different OCI category of work.

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