W81XWH-16-T-0438.docx

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in-silico screening of commercially available database
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W81XWH-16-T-0438
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W81XWH-16-T-0438

Section SF 30 - BLOCK 14 CONTINUATION PAGE

SOW

PERFORMANCE WORK STATEMENT

1. SCOPE: This Performance Work Statement (PWS) defines the procurement of the technical expertise and support services necessary to perform in-silico screening of commercially available database(s) for novel small-molecule drug discovery, docking of drug candidates into protein targets, and performing molecular modeling in support of the Wound Infections Department (WID), Bacterial Diseases Branch, Walter Reed Army Institute of Research (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 identify novel small-molecule drug candidates that may inhibit the function of the protein targets, model drug candidates bound to the protein targets, and perform molecular modeling for drug candidate enhancement.

2. PERIOD OF PERFORMANCE:

Base Period: Date of awrd through 12 months Option Year 1: 12 months Option Year 2: 12 months

3. BACKGROUND:

The Wound Infections Department within the Bacterial Diseases Branch at WRAIR conducts research to defeat combat-related wound infections. WID conducts requirements-driven programmatic research using a multi-disciplinary approach to characterize wound pathogenesis and develop novel antimicrobial countermeasures for wound infections of Service Members. The WID includes the WRAIR X-ray Crystallography Facility, which provides structure-based drug design services to WRAIR, DoD labs, industry, and academic collaborators to support the development of therapeutic and prophylactic countermeasures against bacteria, parasites, and viruses.

4. OBJECTIVES:

4.1. To provide scientific and technical support for the research, development, test, and evaluation of novel medical countermeasures (including drugs, biologics, vaccines, devices, and diagnostics) against wound infection pathogens.

4.2 To provide scientific and technical support for research on wound pathogen biology, such as mechanisms of virulence and drug resistance.

4.3 To provide scientific and technical support for the research and development of animal models for the study of wound infections and the evaluation of medical countermeasures against wound infections.

4.4 To deliver samples of top-scoring novel small-molecule compounds identified by in silico screening of commercially available chemical databases using Government-furnished X-ray crystal structure information.

4.5 To provide scientific and technical support for research and development of diagnostic assays for the identification of wound pathogens and determination of antibiotic resistance patterns.

5. REQUIRED TASKS:

5.1 In-silico Screening for Drug Discovery

The Contractor shall perform in-silico screening of commercially available chemical databases using the crystal structures of bacterial therapeutic targets and malaria (parasite) therapeutic targets, provided by the COR, to identify potential drug candidates.

5.2 Perform Molecular Modeling Studies, the Contractor shall perform molecular modeling to study the protein:hit compound interaction. The protein crystal structures for in-silico studies will be provided by the PI/COR (WRAIR).

5.2.1 The Contractor must be able to integrate biological, chemical, and structural data for each of the therapeutic target compounds.

5.3 The contractor shall have linux operating systems or Mac OS X. available for government use, to determine structure(s) data. The contractor shall have linux operating systems or Mac OS X for running x-ray structure refinement programs in PHENIX and able to write computer scripts such as PERL, linux batch script, and commercial molecular simulations software.

5.4 The contractor should be within 50 miles of WRAIR

The contractor should be within 50 miles of WRAIR to meet with the COR on a weekly basis or as needed. The COR also has to travel to the offsite location to use the contractor’s Linux cluster to refine the x-ray crystal structures of potential therapeutic targets bound to drug hits on a frequent basis.

5.4.1 The contractor would provide approximately 5 drug hits per week to the COR.

5.4.2 The COR would then grow these crystals in complex with the drugs and analyze co-crystal datasets.

5.4.3 To further refine the co-crystal structures the COR needs to commute to the contractor location twice a week to process the data using their linux cluster.

6.0 DELIVERABLES:

6.1 The Contractor shall deliver all deliverables to the Contracting Officer’s Representative at 503 Robert Grant Avenue, Silver Spring, MD 20910-7500.

6.2 The COR shall provide the contractor crystal structures of bacterial therapeutic targets and malaria (parasite) therapeutic targets. The contractor shall use the crystal structures of therapeutic targets to perform insilico screening of 0.5 million compounds per week and provide structures of high scoring compounds within 1 week after identification.

6.3 The contractor shall deliver modifications to lead compounds within one month after identification.

6.4 The contractor shall purchase and deliver samples of at least 25 top scoring compounds (1-10 mg each) for in vitro testing and co-crystallization experiments within 1 week or up to one month after identification.

6.5 The contractor shall deliver suggested mutations to proteins and vaccine candidates to the COR within 1 week of identification

6.6 The contract shall provide technical/functional support to the COR for data processing using the Linux computer cluster

6.7 The contractor shall deliver a quarterly progress report describing all work done in support of this PWS by the 5th day of the month. A report of the in-silico screening results and the identity of the top 100 compounds based on energy minimization scoring. The report shall include the selection requirements (how pharmacophores were developed for screening, molecular weight range, logP values, number of rotatable bonds, etc.), structures of compound leads, modifications to lead compounds, and suggested mutations to proteins (Reports are due in March, June, September and December). The report shall be written in accordance with the CDRL/DID (#DI-MISC-80711A).

7.0 SUPPLIES: No supplies are anticipated to be ordered in support of this task order.

8.0 TRAVEL:

It is the contractor’s responsibility to cover travel costs to meet with the COR weekly or as needed. The contractor shall deliver 25 top scoring compounds to the COR per month.

9.0 WORK SCHEDULE AND LOCATION:

The contractor shall work off-site ie, at the contractor’s location with-in a 50 mile radius of WRAIR, 503 Robert Grant Avenue, Silver Spring, MD.

10.0 CONTRACTING OFFICER’S REPRESENTATIVE: TBD

11.0 AT OPSEC Considerations N/A

11.1. AT Level I Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

11.2. AT Awareness Training for Contractor Personnel Traveling Overseas. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

11.2a. For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

11.2b. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

11.3. AT Awareness Training for Contractor Personnel Traveling Overseas. This standard language requires U.S.-based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)–specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

11.4. iWATCH Training. N/A

11.5. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems. All contractor employees with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DoD Information Assurance Awareness prior to access to the information system and annually thereafter.

11.6. For Contracts That Require an OPSEC Standing Operating program. N/A.

11.7. For Contracts That Require OPSEC Training. Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

13.8. For IA/IT training. All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M, and AR 25-2 within six months of appointment to IA/IT functions.

11.9. For Information Assurance (IA)/Information Technology (IT) Certification. Per DoD 8570.01-M , DFARS 252.239.7001, and AR 25-2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01-M must be completed upon contract award.

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

11.11. For Contract Requiring Performance or Delivery in a Foreign Country. DFARS Clause 252.225-7043, Antiterrorism/Force Protection for Defense Contractors Outside the US, shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non-contingency support. The key AT requirement is for non-local national contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the contractor’s compliance with combatant commander and subordinate task force commander policies and directives.

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

11.13. Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

QASP

Quality Assurance Surveillance Plan (QASP)

1. Purpose: This Quality Assurance Surveillance Plan (QASP) defines the performance standards and performance measures of deliverables indicated in the Contract. The QASP also describes the procedures that the Walter Reed Army Institute for Research (WRAIR) will use to monitor the contractor’s contract performance. It is important to note WRAIR’s primary concern is with the products and services provided by the contractor and not with the procedures used to produce them. Therefore, the QASP focuses on examining the products and services provided by the contractor and not the processes used to produce them. It is intended that the QASP be a tool to guide the Contracting Officer (KO) and the Contracting Officer’s Representative (COR) in assessing contractor performance.

1. QASP Relation to the Solicitation: This QASP is not part of the contract but is included in the solicitation for information purposes. WRAIR will retain the right to change the surveillance methods and Quality Assurance (QA) procedures, or to increase or decrease the degree of surveillance efforts at any time necessary to assure contract compliance.

1. QASP Relation to the Quality Control Plan (QCP): The QCP is a required element of the contractor’s technical proposal in response to the solicitation. While the QCP represents the way in which the contractor will ensure its quality and timeliness of services, as defined in the PWS, the QASP represents the way in which WRAIR will evaluate the contractor’s performance. The contractor’s QCP and the QASP should be complementary programs that ensure successful contract performance.

1. Revisions to the QASP: The QASP is a tool for use in Government administration of the Performance Based Work Statement (PBWS) and remains subject to revision at any time by the Government throughout the contract performance period. Revisions to this surveillance plan are the responsibility of the Contracting Officer’s Representative (COR). Changes may be made unilaterally and need not be announced to the contractor; the Government may provide informational copies to the contractor at its option. The contractor will assume responsibility for all tasks and deliverables in the PBWS under this award. All operational procedures and quality control measures will be tested and implemented. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently unsatisfactory. If observations reveal consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

1. Performance Standard: A performance standard is a level of performance the contractor must meet for each performance measure for each deliverable defined in the Contract. WRAIR is contracting to have all work performed as specified. Any inaccuracies or omissions in services or products are referred to as “defects” on the part of the contractor. The contractor shall be held responsible for all identified defects, and WRAIR may require the work to be re-performed. Performance standards take into account that in some instances an allowable level of deficiencies (deviations) is possible while overall performance continues to meet WRAIR desired level of service. Often deficiencies result from misunderstandings or inadequate communication between contractor, COR and customers. In general, these detected deviations can be quickly corrected and resolved by contractor through communication with COR and customer.

4. Allowable Deviation: The allowable deviation is the level or number of performance deficiencies the contractor is permitted to reach under this contract. Allowable deviations take into account the difference between an occasional defect and a gross number of defects. Allowable deviations can be expressed as a percentage of or as an absolute number (e.g., three per month).

4. Substantially Complete: Many service contracts deal with service outputs that are evaluated using subjective values (e.g., excellent, satisfactory, unsatisfactory). The criteria for acceptable performance and for defects must be defined for these service outputs. The concept of “substantially complete” should be the basis for inspections based on subjective scales. Work is considered “substantially complete” where there has been no significant departure from the terms of the Contract and no omission of essential work. In addition, the contractor has performed the work required to the best of its ability and the only variance consists of minor omissions or deficiencies.

4. Non-performance: Non-performance occurs when the contractor’s performance does not meet or exceed the prescribed performance standard for a given requirement. Requirements may contain multiple performance elements, and therefore, deficiencies may occur in one or more aspects of performance (e.g., timeliness, accuracy, completeness, comprehensiveness, etc.) or subject areas of effort. When inspection and review indicates that the contractor's service output is not in compliance with the Contract requirements, the COR must determine whether the contractor or the Government caused the deficiency. If the cause of the defect rests with the Government, corrective action must be taken through Government channels. If the cause of the defect is due to action or inaction by the contractor, the contractor is responsible for correction of the problem at no additional expense to the Government.

1. Documentation: Thorough documentation of unperformed or poorly performed work is essential for tracking contractor performance throughout the period of performance. The COR will document deficient work by compiling facts describing the inspection methods and results. The COR will develop documentation to substantiate nonconformance with the Contract. The COR will decide whether to elevate the problem to the cognizant Contracting Officer (KO) for corrective action.

1. Remedial Actions: Service contracts allow for penalties in the event that the contractor fails to perform the required services. Penalties are defined as those actions taken under the direction of the KO against the contractor within the general provisions of the Contract for nonconformance. In accordance with FAR 52.246-4: Inspection of Services-Fixed-Price, the Government may require the contractor to re-perform any services that do not conform to contract requirements. If the defects cannot be corrected by re-performance, the KO may either require the contractor to take the necessary action to ensure that future performance conforms to the requirements, or the KO may reduce the Contract price to reflect the reduced value of the services performed. At an extreme decision point, penalties may include a decision not to exercise contract options. The KO will determine the penalty for nonconformance based upon his or her judgment and the severity of the nonconformance.

6. Roles and Responsibilities: The purpose of QA is to ensure that the customers are satisfied with the products and services received from the contractor and to ensure that the contractor is meeting its obligation to WRAIR. The roles and responsibilities of the stakeholders involved in QA are described below.

6. Contractor Responsibility: The contractor is responsible for delivering products or services in accordance with the Contract. The contractor is responsible for implementing a Quality Control Plan (QCP), which is included as part of its technical proposal. The QCP describes the contractor’s methods for ensuring all products and services provided under this Contract meet established deliverables and performance standards. The contractor is responsible for producing, maintaining, and providing for audit, quality control records and reports and all records associated with the investigation. The contractor shall appoint a single quality control point-of-contact to act as a central recipient of communication from the Government. Any additional one page reports required by the Government on the total contract-level will be on an ‘ad-hoc’ basis of no more than three per month.

6. Government Responsibility: This section of the QASP briefly defines the duties and responsibilities of key Government personnel involved in contract administration and quality assurance. The key personnel who will be responsible for QA are the Contracting Officer (CO), the Contracting Officer’s Representative (COR), WRAIR customers.

6. Contracting Officer: The KO has the authority to administer WRAIR Contract. The KO may delegate many of the day-to-day contract administration duties to the COR. However, certain contractual actions such as negotiation and issuance of contract modifications, resolution of contractor claims and disputes, issuance of cure notices, issuance of show-cause letters, termination of the Contract, and Contract close-out functions are retained by the KO. Administrative actions such as invoice approval and issuance of contractor Deficiency Reports (CDR) may be, and normally shall be, delegated by the KO to the COR. For tasks and/or subtasks (e.g., deliverables) which include incentive arrangements (award fee, shared savings, award term, etc.), the COR shall provide recommendations to the KO for action. All communication regarding questions or issues related to QA and inspection will be directed to the KO or the COR. The KO shall approve any revision to the QASP processes or standards.

6. Designated Government Representative: The COR shall be appointed for each task/subtask as required, and shall serve as the first line manager of all tasks and/or subtasks issued under this Contract. The COR represents the KO in the Contracting Officer’s Representative functions and therefore is the contractor's initial point-of-contact with the Government. In turn, the COR may delegate some of his/her responsibilities by appointment of Task Monitors by task/subtask to execute some administrative duties in order to ensure that the QA function is properly executed. If modifications to the Contract, or at the task/subtask level, are necessary, the COR will assist the cognizant KO in preparing and negotiating the modifications. If there are problems with contractor performance, the COR will inform the contractor of the problems and recommend to the KO that adverse contractual actions are appropriate (e.g., CDR, issuance of a cure notice or task/subtask closure) if the contractor fails to correct the problem. Also, the COR must refer differences of contract interpretation to the KO.

6. The COR will perform the actual contract surveillance and report to KO. Some of the key QA contract administration duties of COR include, but are not limited to, the following:

5. Complete surveillance as required by this QASP and the specific task/subtask, and make recommendations to the KO.

5. Make recommendations to the KO for the acceptance or rejection of completed work and for administrative actions based on unsatisfactory work or non-performed work.

5. Identify necessary changes to the task/subtask, prepare WRAIR cost and/or staffing requirements estimates, conduct QA/contractor meetings, approve submittals of effort and/or reports, and maintain work files.

5. Promptly furnish the KO with any requests for changes, deviations, or waivers to the task/subtask, with justifications/rationale.

6. Customers: Customers (users) are the WRAIR and WRAIR associated users supported by the contractor. This includes the Federal employees who will be the recipients of contractor support under this Contract. Customers are responsible for assisting the COR in conducting QA by providing information on contractor performance through a Customer Feedback Program.

1. Quality Assurance Methods:

7. The methods used in the QA process are the Government’s tools to monitor the contractor’s products and services. The means of determining whether the contractor has met all contract requirements will be by three approaches: COR review and approval, customer review, and feedback. Reviews either confirm the contractor’s successful achievement of all performance requirements or highlight areas where defects exist and improvements are necessary. In cases of poor performance, WRAIR may increase the level of review and focus on known problem areas. In either case, the reasons for the change in review will be documented. In all cases, the applicable requirements shall be included in each task/subtask at issuance.

7. COR review and approval: COR review and approval provides a systematic way of looking at service outputs and forming conclusions about the contractor's level of performance in accordance with a planned schedule of deliverables.

7. Customer Feedback: Validated customer review and feedback is a quality assurance method based on customer and contractor interaction. Customers continually receive the outputs of contractor performance and are in a position to evaluate the contractor on a recurring basis. Because customers have a clear stake in the quality of contractor services, they are valuable resource for QA

7. Application: Where there is a case of poor performance or non-performance, customers shall be given a process for notifying the COR. The COR then investigates the report and, if found to be valid, document their findings. The numbers of complaints and resulting inspections depend upon customer awareness and response. If the complaint is valid and caused by poor performance or non-performance by the contractor, the contractor must take appropriate corrective action. A valid complaint is one in which the COR confirms that poor performance or non-performance violates contract requirements.

7. Customer Feedback Process: WRAIR/NMRC customers have a direct line of communication to the COR. It is primarily the responsibility of the contractor to investigate each complaint to determine the problem. While COR can also investigate customer complaints, the responsibility for initial review shall remain with the contractor. At the Government’s discretion, the COR will investigate problems from customer groups and complaints involving major problems with services being provided. The contractor shall take action when a Customer Feedback Record is received. Corrective actions shall be implemented prevent the recurrence of similar problems in the future or detect and fix such problems before a product or service is delivered to a customer. If the customer complaint is found to be invalid, the COR shall educate the customer regarding contract/task/subtask scope of work as it pertains to the customer’s expectations.

7. Analysis and Results: Once the reviews or customer feedback records have been completed, an analysis of the contractor’s performance will be conducted. The purpose of the analysis is to ensure that WRAIR is receiving high-quality products and services from the contractor. COR will review the results, rate contractor compliance with the performance standards, and characterize the contractor’s overall performance. Analysis of all types of contract monitoring will result in one of the following outcomes: excellent performance, satisfactory performance, or unsatisfactory performance.

5. Excellent Performance: Excellent performance is the result of the contractor significantly exceeding the performance requirement being inspected. WRAIR may reduce its level of surveillance when the COR determines there are very few or no deficiencies and the contractor performance has significantly exceeded requirements. The COR may notify the contractor that their performance has been excellent

5. Satisfactory Performance: When the contractor’s performance is satisfactory, performance meets the specified standard and the number of defects does not exceed the allowable deviation. Although the contractor’s performance may be deemed satisfactory, the COR may determine that an increased level of surveillance be used for individual products or services that show defect rates approaching the minimum performance standards. The contractor will be notified by the COR when performance is marginal, or approaching an unacceptable level in any area.

5. Unsatisfactory Performance: When the performance standard for any service has not been met, the contractor’s performance is unsatisfactory, and is, therefore, unacceptable. The following responses are available to the COR regarding that task/subtask:

2. The KO and/or COR meet with the contractor to discuss discrepancies, trends, and intended corrective measures;

2. The level of surveillance is increased until the contractor demonstrates acceptable performance over a period of time.

2. The KO issues a Contract Deficiency Report for each service that WRAIRs not meet its performance standard;

2. Should deficiencies be significant and affect multiple tasks/subtasks, KO action such as a ‘Cure’ notice may be appropriate.

1. Performance Requirements Table:

Performance Requirements Table: The following performance requirements will be used to measure the performance of the Service Provider (contractor). WRAIR Designated Government Representatives (COR) will monitor contractor performance as stipulated in the Contract under the performance based task assignments. The following table outlines contractor responsibilities for performance metrics, performance standards, and surveillance methods:

#
PERFORMANCE OBJECTIVE
PERFORMANCE STANDARD
PERFORMANCE MEASUREMENT
1
Insilico screen 0.5 million compounds per week (PWS section 6.2).
Contractor will report screening of 100% of 0.5 million compounds screened
The COR will read the report and assess its completeness
2
Provide 25 structures of high scoring compounds (PWS section 6.2).
Contractor will provide 100% of structures of high scoring compounds per week
The COR will read the report and assess its completeness
3
Provide modification to compound leads (PWS section 6.3).
Contractor will report modifications to compounds within 1 month
The COR will read the report and assess its completeness
4
Provide 25 compounds for invitro testing (PWS section 6.4).
Contractor will provide100% of 1-10 mg of 25 high scoring compounds within 1 week to 1 month
Surveillance shall take place through acceptance
5
Provide mutations to proteins for enhanced (or decreased) function (PWS section 6.5).
Contractor will report mutations to enhance protein activity or decrease activity ( if necessary) within 1 week
The COR will read the report and assess its completeness
6
Provide technical/functional support for cluster use (PWS section 6.6).
Provide assistance on days the cluster is used as necessary
Surveillance shall take place through observation
7
Quarterly Report (PWS section 6.7).
Contractor will submit a quarterly report describing all work done in support of the PWS (Section 5 and 6) will be delivered by the 5th day of each month (reports due in March, June, September and December).
The COR will read the report and assess its completeness

INSTRUCTIONS TO OFFERORS

1. The Contract Specialist (CS) is the point of contact for this acquisition. Any questions or concerns regarding this acquisition shall be submitted electronically via e-mail to john.l.fitzsimmons8.civ@mail.mil .

2. Question Submission Requirements: Offeror's who have questions pertaining to the solicitation requirements, shall submit questions no later than Wednesday, 31August 2016 , at 11:00 AM Eastern Time to the Contract Specialist at john.l.fitzsimmons8.civ@mail.mil. Offeror's shall submit one set of questions only; multiple e-mails will not be accepted. Questions not submitted electronically will not be answered. Answers to all relevant and appropriate questions will be issued via amendment to the solicitation.

3. Submission of offers. Offeror's shall submit their proposal in accordance with the instructions outlined as stated below. Failure to submit all documents concurrently and in accordance with these instructions may render a proposal UNACCEPTABLE. The offeror's proposal shall consist of three (3) volumes. The Volumes are: I - Business Proposal including completed SF 1449 - Solicitation, Offer and Award, Pricing, Certifications/ Representations; II - Technical; and III - Past Performance. Offeror's are cautioned that regurgitation of the technical requirements or the PWS with a statement of intent to perform DOES NOT reflect an understanding of the requirement or capability to perform. Offeror's are responsible for including sufficient details to permit a complete and accurate evaluation of each proposal. Proprietary information shall be clearly marked.

(a) Proposals are due: Friday, 23 September 2016 at 5:00 p.m. EST and shall be submitted electronically to:

Email to: john.l.fitzsimmons8.civ@mail.mil

(b) Electronic Submissions: Offeror shall provide:

4. Each volume shall be submitted in microsoftword. Any pages that are changed (as a result of negotiations or proposal revisions) should have changed information clearly marked by a vertical line in the right hand margin of the page. The revised pages shall be dated. Each volume shall be clearly labeled with its Title

5. Printing should be single spaced. Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Arial or New Times Roman fonts are required. Tables and illustrations may use a reduced font size no less the 10-point and may be landscape.

6. Format Submissions: The Offeror shall provide:

(a) Format: The submission shall be clearly indexed and logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and RFP number in the header and/or footer. A Table of Contents should be created using the Table of Content feature in MS Word. MS Word (doc) files shall use the following page setup parameters:

Margins - Top, Bottom Left, Right - 1"
Gutter - 0"
From Edge - Header, footer - 0.5"
Page Size, Width - 8.5"
Page Size, Height - 11"

(b) Content Requirement: All information shall be confined to the appropriate volume section file. The Offeror shall insure that submissions are clear, specific, complete and limited to essential matters, sufficient to define the proposal in a concise manner, to permit a complete and accurate evaluation of each proposal. Content shall be indexed (cross-indexed, as appropriate) and logically assembled. Each file of the proposal shall consist of a Table of Contents, Summary Section, and the Narrative discussion. The Summary Section shall contain a brief abstract of the file. Proprietary information shall be clearly marked. The following shall be included in the Narrative discussion:

(i) Volume I - Business Proposal: The volume shall contain the following documentation:

A. Company Cover Letter

B. SF 1449 - Solicitation, Offer and Award with Blocks 12 - 18 completed by the Offeror.

C. Acknowledgment of Solicitation Amendments

D. Representations and Certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically) and Other Statements of Offeror's. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

E. Dun & Bradstreet Number (DUNS), CAGE Code, and Tax Identification Number (TIN)

F. Pricing Schedule - Offeror's are instructed to complete the Contract Line Identification Numbers (CLINs) to include Unit Price with Total price for the service and any discount terms. See SF1449 pages 13 – 15.

G. The Offeror shall provide a statement of the methodology and assumptions utilized as the basis for pricing the service. The price must be sufficiently detailed to evaluate the reasonableness and realism for the proposed level of effort. Offeror's shall address, at a minimum, all escalation factors applied and calculations of all direct cost factors.

H. SF1449, Pricing, and Certifications/Representations, shall not be addressed separately from that submitted in Volume I - Business Proposal. Price information shall be included in Volume I only and shall not be discussed or exhibited in any other part of the Offeror's proposal.

I. Offeror's proposal must stipulate that it is predicated upon all the terms and conditions of this RFP.

(ii) Volume II - Technical: The volume shall include three (3) sections, as follows:

Sub-Section
Page Limitation
Tab A - Executive Summary/Abstract
1 Page
Tab B - Technical Approach
3 Pages
Tab C – Experience
2 Pages

(iii) Volume III - Past Performance: This volume shall contain past performance information regarding similar contracts in size, complexity and scope. This volume shall not exceed 5 pages. Offeror shall submit a listing of three (3) references for Government and/or commercial contracts for the prime Offeror and one (1) reference for each major subcontractor in performance or awarded during the past three years which are relevant to the efforts required by this solicitation. Relevant efforts are defined as services/efforts that are the same as or similar to the effort required by the solicitation. Data concerning the Offeror shall be provided first, followed by each proposed major subcontractor, in alphabetical order. Letters of commitment shall be included for all major subcontractors for their past performance to be considered. Past performance should be within in the last 3 to 5 years. This volume shall be organized in the following sections:

A. Section 1 - Contract Descriptions: This section shall include the following information in the following format:

(1) Contractor/Subcontractor place of performance, CAGE Code and DUNS Number. If the work was performed as a subcontractor, also provide the name of the prime contractor and Point of Contact (POC) within the prime contractor organization (name, current address, e-mail address, and telephone/fax numbers).

(2) Government contracting activity, and current address, Procuring Contracting Officer's name, e-mail address, and telephone/fax numbers.

(3) Government's technical representative/COR, current e-mail address, telephone/fax numbers.

(4) Government contract administration activity and the Administrative Contracting Officer's name, current e-mail address, and telephone/fax numbers.

(5) Contract Number

(6) Contract Type (specific type such as Fixed Price (FP), Cost Reimbursement (CR), Time & Materials (T&M), etc.). In the case of Indefinite Delivery contracts, indicate specific type (Requirements, Definite Quantity, and Indefinite Quantity) and secondary contract type (FP, CR, T&M, etc.).

(7) Awarded price/cost.

(8) Original delivery schedule, including date of start and completion of work.

B. Section 2 - Performance: Offeror's shall provide a specific narrative explanation of each contract listed in Section 1, Contract Description, describing the objectives achieved and detailing how the effort is relevant to the requirement of this solicitation. For any contracts that did not/do not meet the original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The offeror's shall list each time the delivery schedule was revised and provide an explanation of why the revision was necessary. All Request for Deviation and Requests for Waiver shall be addressed with respect to causes and corrective actions. The offeror's shall also provide copy of any Cure Notices or Show Cause Letters received on each contract listed and a description of any corrective action implemented by the Offeror or proposed subcontractor. The offeror's shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

C. Past Performance Questionnaire: A Past Performance Questionnaire (Attachment 1) must be completed and submitted for all references identified in Section 1, Contract Descriptions. The Offeror shall complete Part I of the Past Performance Questionnaire and e-mail the questionnaire for the past/current contract. The POCs shall be instructed to electronically complete Part II of the questionnaire and e-mail the entire questionnaire to the Contracting Office no later than the proposal due date, to john.l.fitzsimmons8.civ@mail.mil. The Offeror shall e-mail to the Contracting Officer a list of all the POC's who were sent a questionnaire. The Government must receive this list no later than the proposal due date. The POC List shall contain the following information: Solicitation Number; Company Name; Contract Number; Government Agency; POC Name, Title, Telephone number, e-mail; and Date the Offeror sent the E-mail to the POC (Month/Day).

D. Submissions: Offeror's are discouraged from providing points of contact with another contractors' facility, i.e., in case an Offeror (or one of his/her team members) is in a subcontract with another contractor who has submitted a proposal on the same requirement. Offeror's shall provide and submit the prime contract number and all Governmental agency POCs in lieu of subcontract numbers or prime contract POCs in situations as described above.

E. The following volumes of material shall be submitted:

VOLUME TITLE
MAXIMUM PAGES
I - Business Proposal - SF 1449 - Solicitation, Offer and Award, Pricing, and Certification/ Representations,
N/A
II - Technical - Technical Approach, and Experience
6
III - Past Performance
5

Offeror's are hereby notified that a proposal submitted that exceeds the 11 page limitation shall be evaluated only up to the 11th page. Any pages in excess of 11 will not be evaluated. The following items are not included in the page limitations:

(i) Cover Pages

(ii) Table of Contents

7. Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

8. Late submissions, modifications, revisions, and withdrawals of offers will be addressed in accordance with FAR 15.208.

Section SF 1449 - CONTINUATION SHEET

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12
Months

in-silico screening Base year

FFP

Provision of labor and materials necessary to perform requirements outlined in the performance work statement (PWS).

FOB: Destination

PURCHASE REQUEST NUMBER: 0010869201

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Job

CMR

Contract Manpower Reporting

PURCHASE REQUEST NUMBER: 0010869201

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT

Job

ODC's Base year

COST

Other Direct Costs necessary to perform requirements outlined in the performance work statement (PWS).

ESTIMATED COST

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Job

Quarterly report CDRL Exhibit A

Contract Data requirments List (CDRL) exhibit Data Item 80711A

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12
Months
OPTION
in-silico screening OP1

FFP

Provision of labor and materials necessary to perform requirements outlined in the performance work statement (PWS).

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Job
OPTION
CMR OP1

FFP

Contract Manpower Reporting

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT

Job

OPTION
ODC's OP1

COST

Other Direct Costs necessary to perform requirements outlined in the performance work statement (PWS).

ESTIMATED COST

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Job
OPTION
Quarterly report CDRL Exhibit A

FFP

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12
Months
OPTION
in-silico screening OP2

FFP

Provision of labor and materials necessary to perform requirements outlined in the performance work statement (PWS).

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Job
OPTION
CMR OP1

FFP

Contract Manpower Reporting

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT

Job

OPTION
ODC's OP1

COST

Other Direct Costs necessary to perform requirements outlined in the performance work statement (PWS).

ESTIMATED COST

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Job
OPTION
Quarterly report CDRL Exhibit A

FFP

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN
INSPECT AT
INSPECT BY
ACCEPT AT
ACCEPT BY
0001
Destination
Government
Destination
Government
0002
Destination
Government
Destination
Government
0003
Destination
Government
Destination
Government
0004
Destination
Government
Destination
Government
1001
Destination
Government
Destination
Government
1002
Destination
Government
Destination
Government
1003
Destination
Government
Destination
Government
1004
Destination
Government
Destination
Government
2001
Destination
Government
Destination
Government
2002
Destination
Government
Destination
Government
2003
Destination
Government
Destination
Government
2004
Destination
Government
Destination
Government

DELIVERY INFORMATION

CLIN
DELIVERY DATE
QUANTITY
SHIP TO ADDRESS
DODAAC
0001
POP 28-SEP-2016 TO

27-SEP-2017

N/A
WALTER REED ARMY INSTITUTE OF RESEARCH

W03K W REEDARMYINSTRSCH(WRAIR)

ROBERT GRANT AVENUE

BLDG 503

SILVER SPRING MD 20910-7500

210-221-7877

W74MYF

0002
POP 28-SEP-2016 TO

27-SEP-2017

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

0003
POP 28-SEP-2016 TO

27-SEP-2017

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

0004
POP 28-SEP-2016 TO

27-SEP-2017

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

1001
POP 28-SEP-2017 TO

27-SEP-2018

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

1002
POP 28-SEP-2017 TO

27-SEP-2018

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

1003
POP 28-SEP-2017 TO

27-SEP-2018

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

1004
POP 28-SEP-2017 TO

27-SEP-2018

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

2001
POP 28-SEP-2018 TO

27-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

2002
POP 28-SEP-2018 TO

27-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

2003
POP 28-SEP-2018 TO

27-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

2004
POP 28-SEP-2018 TO

27-SEP-2019

N/A
(SAME AS PREVIOUS LOCATION)

W74MYF

CLAUSES INCORPORATED BY REFERENCE

52.204-7
System for Award Management
JUL 2013
52.204-13
System for Award Management Maintenance
JUL 2013
52.232-1
Payments
APR 1984
52.232-8
Discounts For Prompt Payment
FEB 2002
52.232-11
Extras
APR 1984
252.201-7000
Contracting Officer's Representative
DEC 1991
252.203-7000
Requirements Relating to Compensation of Former DoD Officials
SEP 2011
252.204-0009
Contract-wide: by Fiscal Year
SEP 2009
252.204-7000
Disclosure Of Information
AUG 2013
252.204-7003
Control Of Government Personnel Work Product
APR 1992
252.204-7006
Billing Instructions
OCT 2005
252.204-7007
Alternate A, Annual Representations and Certifications
JAN 2015
252.204-7008
Compliance With Safeguarding Covered Defense Information Controls
DEC 2015
252.204-7012
Safeguarding Covered Defense Information and Cyber Incident Reporting.
DEC 2015
252.209-7002
Disclosure Of Ownership Or Control By A Foreign Government
JUN 2010
252.225-7048
Export-Controlled Items
JUN 2013
252.227-7000
Non-estoppel
OCT 1966
252.227-7015
Technical Data--Commercial Items
FEB 2014
252.227-7024
Notice and Approval of Restricted Designs
APR 1984
252.227-7037
Validation of Restrictive Markings on Technical Data
JUN 2013
252.232-7003
Electronic Submission of Payment Requests and Receiving Reports
JUN 2012

CLAUSES INCORPORATED BY FULL TEXT

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (OCT 2015)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers

Offeror's shall submit their quote in accordance with the instructions outlined below. Failure to submit all documents concurrently and in accordance with these instructions may render a proposal UNACCEPTABLE. The offeror's proposal shall consist of three volumes:

Volume I – Business quote
Volume II – Technical quote
Volume III – Past Performance

(1) Quote Due Date: Friday 23 September 2016 at 3:00 P.M. Eastern Standard Time submitted to Mr. John Fitzsimmons via e-mail to john.l.fitzsimmons8.civ@mail.mil.

(2) Document Format Submission:

The submission shall be clearly indexed and logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and RFQ number in the header and/or footer. A Table of Contents should be created using the Table of Content feature in MS Word. MS Word (doc) files shall use the following page setup parameters:

Margins - Top, Bottom Left, Right - 1"
Gutter - 0"
From Edge - Header, footer - 0.5"
Page Size, Width - 8.5"
Page Size, Height - 11"

Printing should be single spaced. Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Arial font is required.

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