Attachment_1_PWS.docx

PERFORMANCE WORK STATEMENT (PWS)

Attachment 1

Global Metabolomics, Lipidomics, and/or Targeted Metabolites of Biospecimens

United States Army Center for Environmental Health Research

SECTION 1 PURPOSE

1.1. Introduction

The United States Army Center for Environmental Health Research (USACEHR) conducts research, development, testing, and validation for occupational and environmental health surveillance and environmental health technology and for diseases of military relevance in support of Force Health Protection.

1.2. Mission

The mission of USACEHR is to develop surveillance capabilities to detect, assess, and prevent health effects from adverse environmental, physiological, and psychological exposures and to apply integrative biology approaches to diseases of military relevance. USACEHR uses genomics, proteomics, and high performance computing to accelerate the pace of discovery for biomedical applications through the use of biological experimentation that is tightly linked to mathematical models and a better understanding of biological networks and molecular biology. With support from USAMRMC (United States Army Medical Research and Materiel Command), USACEHR hopes to increase its efforts in this exciting area while contributing to Command-wide applications of systems biology approaches.

1.3. Background

Metabolomics endpoints are critical in assessing exposure and adverse health effects and physiological conditions relevant to protection of Service member health. USACEHR requires accurate and comprehensive metabolomics endpoints to assess metabolites in biological specimens, including, but not limited to, tissue, fecal material, and/or plasma. The aim of USACEHR’s studies is to adapt these changes in metabolic networks to assays and treatments for conditions relevant to Force Health Protection in field and garrison settings.

1.4. Scope

Both USACEHR and USAMRMC require metabolomics services to support their programmatic research. These services will provide high-quality global metabolomics, lipidomics, and/or targeted metabolite analysis of biological materials, including, but not limited to, tissue, fecal material and plasma specimens in animals and/or humans. The contractor shall:

1.4.1. Provide USACEHR and USAMRMC the ability to analyze and catalogue the biochemical, fatty acid, lipid, and/or metabolic changes in biological material, including, but not limited to, tissues, fecal material, and/or plasma.

1.4.2. Provide the basis to determine whether future specialized analysis and techniques will be required.

1.4.3. Generate data to integrate with physiological and various "-omics" data related to the project.

1.5. Organizational Conflict of Interest (OCI) (Deliverable 1, Exhibit 1).

This contract will be used to procure U.S. Army Medical Research and Material Command (USAMRMC) OCI Category 2 (Program and/or Administrative Support) that falls within the scope of the Performance Work Statement (PWS). The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

1.6. Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2).

The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

1.7. Contract Type

The Government will be procuring a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract with individual task orders. Funding will be provided against each task order that will identify the required task needed.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance

The place of performance shall be the contractor’s facility.

2.1.2. Period of Performance.

Base Year 08/13/18 –08/12/19 with four (4) option period:

Option Period 1 08/13/19 –08/12/20 Option Period 2 08/13/20 –08/12/21 Option Period 3 08/13/21 –08/12/22 Option Period 4 08/13/22 –08/12/23

2.2. 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.If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

2.2.1. The contractor shall provide non-personal services carrying out analytical studies to compare and report the statistically significant biochemical differences between control specimens and corresponding experimental cohorts.

2.2.2. The contractor shall employ a fast and reproducible method directly reflecting biochemical events through the determination of changes in the levels of metabolites (including, but not limited to, small molecules, complex lipids, and fatty acids) in biological samples, including, but not limited to, tissue, fecal samples, and/or plasma. The contractor’s method must have the sensitivity and specificity to accurately determine differences in metabolic profiles in response to experimental conditions such as physiological stimuli or genetic modification.

2.2.3. The contractor shall perform statistical analysis and report biochemical interpretations of the results.

2.3. Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) for this contract will be appointed by the KO. The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2. 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. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

2.4. Reports

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in 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.

2.4.2. Contract Manpower Reporting (Deliverable 3). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

2.4.2.1. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the “Global Metabolomics, Lipidomics, and/or Targeted Metabolites of Biospecimens” 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.

2.4.2.2. 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 2017. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. The contractor shall provide global metabolomic analyses, lipidomics, targeted metabolite analysis, statistical analysis of quantitative data, biological interpretation of observed changes, and various reporting requirements, to include summary reports and web-based access with data visualization tools. The contractor shall also provide the raw data associated with all analyzed samples. The contractor shall have the capacity to perform global, semi-quantitative metabolomics, quantitative metabolomics, and generate a fully quantitative profile of the concentrations and fatty acid composition of neutral and polar lipid classes from the Government-supplied biospecimens. The Government will specify which analyses, deliverables, and specimen types and numbers are required for each study in each individual Task Order.

3.1.2. General Requirements. The contractor shall:

3.1.2.1. Provide advice on preparing biological specimens that will be submitted for analysis to ensure preservation of the small molecule, metabolic, or lipid entities. This may require diagnostic samples being analyzed by the contractor to identify the suitability of different biospecimen substrates for analysis (Deliverable 4).

3.1.2.2. Provide all necessary personnel required to perform services at the contractor’s facility.

3.1.2.3. Provide support services for the high-quality global metabolomic and/or fatty acid content analysis on biological materials, including, but not limited to, tissue, fecal material and plasma specimens in animals and/or humans.

3.1.3. Specific Analyses: The Government will specify which analyses, deliverables, and specimen types are required for each study. The Government will specify the numbers of specimens per unit of work. The contractor shall provide the Government with the following Deliverables, described in each individual task order, within three (3) months of biospecimen submission:

3.1.3.1. Global Metabolomic Analysis. The contractor shall:

3.1.3.1.1 Perform global metabolomic analysis of biological specimens supplied by the Government, to include, but not limited to, tissue, fecal samples, and/or plasma (Deliverable 5).

3.1.3.1.2. Perform customized sample preparation per the requirements of the Government (for global metabolomic analysis) (Deliverable 6).

3.1.3.1.3. Evaluate samples for the presence of metabolites utilizing liquid chromatography-mass spectromety (LC-MS) and/or gas chromatography-mass spectrometry (GC-MS) technologies, or an acceptable technological substitute determined by the Government, for global metabolomic analyses (Deliverable 7).

3.1.3.1.4. Provide raw and analyzed quantitative data of the relative concentration profile of the small-molecule entities identified in the specimens in a non-proprietary electronic format (Deliverable 8).

3.1.3.1.5. Deliver a report of the relative concentration profile obtained from small-molecule entities that have been extracted from the biospecimens and identified by LC-MS and GC-MS detection systems, or an acceptable technological substitute determined by the Government (small molecules will include Amino Acids, Carbohydrates, Lipids, Nucleotides, Microbiota-Related Molecules, Energy-Associated Molecules, Cofactors, Vitamins, Xenobiotics, and Novel Metabolites) (Deliverable 9).

3.1.3.2. Lipidomics Analysis. The contractor shall:

3.1.3.2.1. Perform lipidomics analysis of biological specimens supplied by the Government, to include, but not limited to, tissue, fecal samples, and/or plasma (Deliverable 10).

3.1.3.2.2. Perform customized sample preparation per the requirements of the Government for lipidomics analysis (Deliverable 11).

3.1.3.2.3. Evaluate samples for the presence of metabolites utilizing LC-MS and GC-MS technologies, or an acceptable technological substitute determined by the Government, for lipidomics (Deliverable 12).

3.1.3.2.4. Provide absolute quantitation, molecular species concentrations, and complete fatty acid composition of lipid class.(i.e., at least 1,000 molecular species across at least 14 lipid classes, including principle phospholipid, sphingolipid, and neutral lipid classes) in a non-proprietary electronic format (Deliverable 13).

3.1.3.2.5. Deliver a report of the fully quantitative profile of lipids identified by LC-MS and GC-MS detection systems, or an acceptable technological substitute determined by the Government (Deliverable 14).

3.1.3.3. Targeted Metabolite Analysis. The contractor shall:

3.1.3.3.1. Perform targeted metabolite analysis of biological specimens supplied by the Government, to include, but not limited to, tissue, fecal samples, and/or plasma (Deliverable 15).

3.1.3.3.2. Perform customized sample preparation per the requirements of the Government for targeted metabolite analysis (Deliverable 16).

3.1.3.3.3. Evaluate samples for the presence of metabolites utilizing LC-MS and GC-MS technologies, or an acceptable technological substitute determined by the Government, for targeted metabolite analysis (Deliverable 17).

3.1.3.3.4. Provide targeted metabolite assays that can be used to track biomarkers and improve biological understanding by assessing particular metabolites. This may include, but is not limited to, a Fatty Acid Metabolism Panel, an Acylcarnitine Panel, a Bile Acid Panel, a Cholesterol Metabolism Panel, and a Stratum Corneum Panel in a non-proprietary electronic format; if a targeted metabolite assay is not available, the contractor shall develop a customized panel for a Government-specified number of molecules (Deliverable 18).

3.1.3.3.5. Deliver a report of the fully quantitative profile of targeted metabolite(s) identified by LC-MS and GC-MS detection systems, or an acceptable technological substitute determined by the Government (Deliverable 19).

3.1.3.4. Quantitative Data Analysis. The contractor shall:

3.1.3.4.1. Perform statistical and classification analyses of quantitative data from either the metabolomic or lipidomic analyses, to include, but not limited to, principal component analysis, ANOVA (analysis of variance) with contrasts, and random forest analyses (Deliverable 20).

3.1.3.4.2. Ensure that appropriate statistical methods are used based on types of data, distribution of data, and any other parameters required to ensure approriateness of the statistical model (Deliverable 21).

3.1.3.4.3. Deliver a report of the raw data as well as the Statistical and Classification Analysis of the resulting data from Global Metabolomics, Lipidomics, and/or Targeted Metabolites of Biospecimens (Deliverable 22).

3.1.3.5. Biological Interpretation. The contractor shall:

3.1.3.5.1. Provide a biochemical interpretation of selected, statistically significant, named compounds (i.e., known chemical structure) using pathway analysis tools, including, but not limited to, (i) figures illustrating the biochemical pathways significantly enriched in the analysis, identifying the location of key metabolites within metabolic networks and pathways, including, but not limited to, amino acid metabolism, cofactor and vitamin metabolism, nucelotide metabolism, microbiome metabolism, carbohydrate metabolism, energy metabolism, lipid metabolism, and novel metabolites, (ii) line graphs identifying dose, time, and/or other significant trends in differentially expressed biochemicals, (iii) a peer-reviewed literature-supported narrative describing how the altered biochemical pathways affect physiology (Deliverable 23).

3.1.3.6. Reporting Requirements. The contractor shall:

3.1.3.6.1. Integrate the biochemical interpretation into a final report summarizing the statistical and biological conclusions of the study, including, but not limited to:

3.1.3.6.1.1. Figures illustrating the biochemical pathways significantly enriched in the analysis, identifying the location of key metabolites within metabolic networks and pathways, including, but not limited to, amino acid metabolism, cofactor and vitamin metabolism, nucelotide metabolism, microbiome metabolism, carbohydrate metabolism, energy metabolism, lipid metabolism, and novel metabolites;

3.1.3.6.1.2. Line graphs identifying dose, time and/or other significant trends in differentially expressed biochemicals;

3.1.3.6.1.3. A peer-reviewed literature-supported narrative describing how the altered biochemical pathways affect physiology (Deliverable 24).

3.1.3.6.2. Provide access to a Client Portal tool which includes heat maps, charts, pathway enrichment analyses, and an annotated Network View of the data (Deliverable 25).

3.1.3.6.3. Provide access to Web-based tools for intuitive data visualization of lipids identified in the quantitative profiles and for the determination of the fatty acid composition of neutral and polar lipid classes (Deliverable 26).

3.1.3.6.4. Provide access to Web-based tools for intuitive data visualization of small molecules identified in the relative concentration profile (Deliverable 27).

3.2. Performance Requirement Summary (PRS) Matrix

3.2.1. The Government will specify which Deliverables (Required Tasks) are required for each individual task (i.e., study).

Standard

PRS 21. Integrate the biochemical interpretation into a final report deliverable summarizing the statistical and biological conclusions of the study.

SECTION 4 SPECIAL REQUIREMENT

4.1 Government Furnished Supplies and Materials

4.1.1. The Government will provide the contractor with biospecimens, to include but not limited to tissue, plasma, and/or fecal specimens. The contractor shall provide advice on preparing the biospecimens while preserving metabolic entities for analysis. The contractor shall supply packaging and storing conditions for shipment. The Government will ship specimens by a suitable postal carrier (e.g., FedEx or another entity) according to the packaging and storage condition recommendations of the contractor.

4.1.2. The Government will submit an electronic manifest of pertinent sample information to the contractor.

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

4.2.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA) IAW applicable statutory, regulations, local policies and procedures.

4.2.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the contracting officer grants specific exception.

4.2.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.2.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.3. Quality Assurance Surveillance Plan (QASP). Every DoD contract awarded for services in excess of $2,500.00 shall contain a QASP IAW FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in the Request for Proposal (RFP) and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 5 DELIVERABLES

5.1. Deliverables. The Government will specify which Deliverables (Required Tasks) are required for each study. The contractor shall provide the following deliverable as specified by the Government for each study:

E, electronic H, hardcopy

NOTE: The contractor shall deliver all specified deliverables within three (3) months after the receipt of the biospecimens.

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Environmental Requirements

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1, Environmental Protection and Enhancement.

6.1.2. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

6.2. Applicable Directives. Not Applicable.

SECTION 7 DEFINITIONS AND ACRONYMS

7.1. Definitions

7.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

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

7.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

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

7.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

7.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.10. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.1.12. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

7.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

7.2. Acronyms

The acronyms listed below will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.

NON-DISCLOSURE STATEMENT

EXHIBIT 2: NON DISCLOSURE STATEMENT

Non-Disclosure Agreement for Contractor Employees and Subcontractors.

I, __________, am an employee of or a subcontractor to the U.S. Army Military Research and Materiel Command to [Company Name], a Contractor acting under contract to the <Organization and name of service> under Prime Contract No. W81XWH-16-D-XXXX. I understand that in the performance of this task, I may have access to sensitive or proprietary business, technical, financial, and/or source selection information belonging to the Government or other Contractors. This information includes, but is not limited to, cost/ pricing data; Government spend plan data; Planning, Programming, Budgeting and Execution (PPBE) documents and information, as defined in Department of Defense (DoD) Directive 7045.14; Contractor technical proposal data; independent government cost estimates; negotiation strategies and Contractor data presented in negotiations; contracting plans and statements of work. I agree not to use, discuss, divulge, or disclose any such information or data to any person or entity except those persons directly concerned with the use or performance of this delivery order. I have been advised that the unauthorized disclosure, use or negligent handling of the information by me could cause irreparable injury to the owner of the information. The injury could be source sensitive procurement information of the government or proprietary/trade secret information of another company.

I understand that the United States Government may seek any remedy available to it to enforce this Agreement, including, but not limited to, application for a court order prohibiting disclosure of information in breach of this agreement. Court costs and reasonable attorney fees incurred by the United States Government may be assessed against me if I lose such action. I understand that another company might file a separate claim against me if I have misused its proprietary information.

In the event that I seek other employment, I will reveal to any prospective employer the continuing obligation in this agreement prior to accepting any employment offer.

The obligations imposed herein do not extend to information/data which is:

a. in the public domain at the time of receipt or it came into the public domain thereafter through no act of mine;

b. disclosed with the prior written approval of the <Organization> designated Contracting Officer;

c. demonstrated to have been developed by [Company Name], or me independently of disclosures made hereunder;

d. disclosed pursuant to court order, after notification to the <Organization> designated Contracting Officer;

e. disclosed inadvertently despite the exercise of the same reasonable degree of care a party normally uses to protect its own proprietary information.

I have read this agreement carefully and my questions, if any, have been answered to my satisfaction.

(Printed Name of Employee or Subcontractor) Date

(Signature) Organization

(Signature of Corporate Official) Date

(Printed Name of Corporate Official) (Printed Title –Task Manager or higher)

OCI CERTIFICATION

EXHIBIT 1: ORGANIZATIONAL CONFLICT OF INTEREST

1. The U.S. Army Medical Research Materiel Command (USAMRMC) has categorized all service procurements into one of the following three as defined below, for purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (OCIs) in accordance with (IAW) the Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1 – USAMRMC Internal. 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. 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.

Category 2 - Program and/or Administrative Support. Services which assist in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business, process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3 - Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, commercial off the shelf (COTS) procurement and integration, internal development testing, deployment, installation, operations, and maintenance. 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.

2. 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.

3. The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that USAMRMC presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current contractors and prospective Offerors in developing their own business strategies regarding participation in the U.S. Army Military Research and Materiel Command (USAMRMC) 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 USAMRMC requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

4. For purposes of identifying, avoiding and mitigating against OCIs, USAMRMC will examine all its service requirements and acquisitions regardless of the cognizant contracting activity (e.g., U.S. Army Medical Research Acquisition Activity (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 Indefinite Delivery Indefinite Quantity IDIQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

5. Each USAMRMC’s service procurement solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract has been determined by USAMRAA to fall within the following USAMRMC OCI categories:

Category 2 - Program and/or Administrative Support.

6. USAMRAA will administer this clause for purposes of award eligibility for each solicitation as follows:

a. An Offeror that has never provided support to USAMRMC in any of the categories is eligible for award in any category without any further action required under this clause.

b. An Offeror that provides or has provided support to USAMRMC in only one category of work and has never supported USAMRMC in any other category (a single-category Contractor) is eligible for award for any future requirement in that single category without further action under this clause.

(1) A single-category Offeror/Contractor wishing to submit an offer in a different category, or any Offeror/Contractor which now provides or previously has provided support in more than one category, must include the following as part of its offer:

(i) Perform a comparative analysis of the potential new work against all current and previous work performed in support of USAMRMC in any category other than that of the new work being offered. 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.

(ii) 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 Avoidance or Mitigation Plan with its proposal.

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

7. The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, IAW the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements.

a. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined, for purposes of this clause, to be eligible for award.

b. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

c. 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.

8. 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.

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

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

a. 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?