W911QY-16-R-0039_SABERx.pdf

CODE

(Hour)

PAGE(S)

until 12:00 PM local t ime 08 Aug 2016

X

A X B X C X D

EX

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G F 40 - 45

46 - 71 X H 72 - 77 richard.w.totten2.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

DO-C9 1 77

(If other than Item 7) W911QY

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W911QY 8. ADDRESS OFFER TO

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and

Specif ied in Item 8 conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

RICHARD TOTTEN 301-619-2446

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 4

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

5 - 11

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

14 X K REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 15 - 16 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 17 - 29 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIO NS AND INSTRUCTIO NS

PART III - LIST O F DO CUMENTS, EXHIBITS AND O THER ATTACHMENTS

30 - 38

PART II - CO NTRACT CLAUSES

W6QK ACC-APG NATICK

CONTRACTING DIVISION

BLDG 1 GENERAL GREENE AVENUE

NATICK MA 01760-5011

W6QK ACC-APG NATICK

110 THOMAS JOHNSON DR SUITE #240

FREDERICK MD 21702

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

08 Jul 2016

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W911QY-16-R-0039

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 UNDEFINED

SABER Support

CPFF

Southeast Asia (SEA) Biosurveillance and Epidemiology Research Support, to include Section J data deliverable requirements.

FOB: Destination

MAX COST

FIXED FEE

TOTAL MAX COST + FEE

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Travel for CPFF Task Orders

CPFF

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0003 UNDEFINED

SABER Support

FFP

Southeast Asia (SEA) Biosurveillance and Epidemiology Research Support, to include Section J data deliverable requirements.

MAX

NET AMT

Travel for FFP Task Orders

FFP

0005 2 Each Contractor Manpower Reporting

FFP

Annual Contractor manpower reporting.

CLIN DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER

VALUE

The minimum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not be less than the minimum quantity and order value stated in the following table. The maximum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not exceed the maximum quantity and order value stated in the following table.

CLIN

MINIMUM

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

$2,500.00 $5,000,000.00

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

SOUTHEAST ASIA BIOSURVEILLANCE & EPIDEMIOLOGY RESEARCH (SABER)

C.1 Background & Purpose

Contemporary pandemics and outbreaks of disease, such as the recent Ebola outbreak and emergence of the Middle East Respiratory Syndrome (MERS) and Zika virus, serve as poignant reminders of our global vulnerability to emergent human health threats. Current global disease control focuses almost exclusively on responding to pandemics after they have emerged, highlighting our current inability to predict or prevent such events.

Nevertheless, dramatic failures in pandemic control such as the ongoing lack of success in HIV vaccine development more than a generation into the pandemic, have shown that this wait-and-respond approach is not sufficient. The development of systems to prevent pandemics before they are established should be considered imperative to human health. The early detection of emergent threats to human health is all the more important given the speed with which disease causing agents are now capable of being distributed around the globe through air travel and global trade. Because the success of a pathogen depends on its ability to spread from human-to-human and on the number of susceptible individuals, our ability to cross continents in a single day poses a unique new challenge to emerging infectious disease control. In today’s world of global interconnectedness, a pathogen that may have remained a regional phenomenon in an era before globalization now has few barriers to rapid global distribution.

Despite this, our current disease surveillance systems and our ability to identify and respond to emergent diseases early are inadequate. Developing more robust surveillance programs to identify pathogens early and to respond to their emergence appropriately is crucial to a coherent strategy for combating future threats infectious disease threats to human health.

The Naval Medical Research Center – Asia (NMRC-A), based in Singapore, is at the forefront of the U.S.

Department of Defense (DoD)’s disease surveillance efforts in the PACOM Area of Responsibility (AOR). Within the context of its ongoing disease surveillance activities, the NMRC-A is well-positioned to evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and to develop local expertise via training to detect and respond to emergent disease threats. In consonance with its mission, the NMRC-A requires contractor services to support the ongoing development, performance and management of research across the Southeast Asia (SEA) region and in collaboration with host-country partners.

C.2 General Requirements

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform under this contract, as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property (GFP) and services, if any (there is no GFP identified at this time; any GFP will be specifically identified at the task order level). Performance includes management, oversight, establishing procedures for planning, allocating, and controlling resources for awarded task orders; scheduling, budgeting, and accumulating expenditures (hours and dollars); identifying expenditure and schedule problems; tracking order performance; and providing timely detailed performance status to the Government. Management includes administrative functions performed to oversee an infectious disease research program (e.g., biosurveillance, vector control, and vaccine efficacy programs) from initiation to completion, including but not limited to; report generation to the Government principal investigator(s) and funding sponsors; initiating new field sites; establishing agreements in-country; tracking technical progress and expenditures; travel management, and general oversight of research program resources in-country. The contractor shall perform to the standards in this contract to accomplish the following general requirements:

C.2.1 Administrative and logistical support of NMRC-A. This support will include project management and financial management support, tracking programmatic milestones, preparing internal/external research and contract documents, material/supply procurement support, program logistics, managing of regulatory requirements for human and animal research, and translation of project/protocol documents from English to local languages and vice versa. This support will also involve providing management between the US Government and potentially foreign personnel located at the client’s site or AOR.

C.2.2 Design and conduct of protocols with NMRC-A and in-country partners to conduct epidemiology studies.

This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NMRC-A. Examples of current projects include population-based studies of acute febrile illness, multi-year prospective cohort studies to evaluate the risk potential of emerging viral pathogens, and retrospective and prospective epidemiological studies of emerging disease threats in the SEA region.

C.2.3 Design and conduct of protocols with NMRC-A and in-country partners to evaluate novel disease diagnostics and therapeutic interventions, as well as disease and vector control strategies. This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NMRC-A. Examples of current projects include sensitivity and functionality testing of Role 0 and Role 1 portable diagnostic assays, vector mapping studies related to tick-borne and bat-borne pathogens in Laos, and spatial repellency studies involving mosquitoes in the Mekong Delta.

C.2.4 Design and conduct training with NMRC-A and in-country partners to develop regional expertise to detect and respond to emergent disease threats. This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with NMRC-A. Examples of current projects include the Biosecurity Engagement Program (BEP) in collaboration with the US DoS, laboratory capacity building and biosafety initiatives in Malaysia, and ongoing biosurveillance and emerging disease response activities in support of the Global Emerging Infection Surveillance (GEIS) network.

C.2.5 Serve as subject matter experts and liaisons to sub-contractors and host-country partners within the above associated mission areas.

C.2.6 Quality Control

The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program (QCP) is the means by which he assures himself that his work complies with the requirement of the contract.

C.2.7 Quality Assurance

The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP), Attachment 1 in Section J. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

C.2.8 Individual Task Orders

C.2.8.1 Each Task Order awarded under this contract will have its own PWS identifying performance of the required efforts for NMRC-A. Task Order PWSs shall be specific as to descriptions of work to be performed, duration of work to be performed, and location of work to be performed under each Task Order.

C.2.8.2 This contract will accommodate both severable and non-severable Firm-Fixed-Price (FFP) and Cost-Plus-Fixed-Fee (CPFF) type task orders (CPFF being dependent upon the contractor possessing an acceptable accounting system with DCAA-approved indirect rates). Upon ordering, CPFF type task orders will be deemed either completion or term form. The completion form describes the scope of work by stating a definite goal or target and specifying an end product (e.g., a final report of research accomplishing a goal or target) such that completion of the goal, target, or end product is necessary in order for the

Government to successfully receive such benefit. The term form describes the scope of work in general terms and obligates the contractor to devote a specified level of effort for a stated period of time. A term or level of effort may have monthly and final reports (as per the CDRLs) but completion of such reports does not prohibit the Government from successfully receiving the benefit. The term form is not a time and material type contract or fixed labor rate contract in this context. In accordance with FAR 52.232-20— Limitation of Cost, for completion-form CPFF task orders, the contractor will be required to notify the Contracting Officer if the total cost for performance will be either greater or substantially less than previously estimated. In the case of the latter, the Contracting Officer may negotiate total fee downward to be commensurate with actual work performed.

C.3 Local Staffing Sources

For this contract it is anticipated that a prime contractor will work in conjunction with local solution partners or subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving NMRC-A the most cost effective solution, while maintaining an acceptable level of technical performance. Any prime contractor working in-theater AOR will ensure compliance with, and be responsible for, all local tax and labor laws in the country of operation.

This includes ensuring that any subcontractor(s) are also in compliance with local laws. Any prime contractor will also ensure compliance with the cognizant US command of the relevant regions and the US State Department, as there may be high risk when entering into the area.

C.4 Period of Performance

The ordering period for this contract shall be for two (2) years, starting on 1 Sep 2016 and ending on 30 Aug 2018.

The period of performance for each task order issued shall be of one (1) year duration or less, except for unique instances in which the needs of a specific research study or program require the use of a task order exceeding that limit, such as when supporting a non-severable, continuous research study with a specified duration of time needed to achieve a conclusive end result.

C.5 Phase In/Out Period (As needed)

To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have a sufficient amount of personnel on board, during the 30-day phase in/ phase out periods.

During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

C.6 Scientific/Technical Requirements

In addition to the US management provided under this contract, the purpose of this acquisition includes providing scientific/technical (including administrative support) services in support of medical research and development, whether that be directly provided by the prime contractor or indirectly provided by a host-country subcontractor, or a third party entity not under this contract, for NMRC-A that are not personal services, inherently governmental functions, or subject to OMB Circular A76. NMRC-A R&D activities are generally categorized under the following topic areas: (1) Disease Surveillance and Epidemiology, (2) Evaluation of Novel Diagnostics, Therapeutic Interventions, and Vector Control Strategies, (3) Disease Ecology, and (4) Capacity Development and Training.

Support for these activities will include, but is not limited to: general project oversight; study protocol and document development; development and validation of training materials and standard operating procedures, management of the regulatory requirements pertaining to the conduct of ethical human and animal research (e.g. IRB submissions and approvals); non-Governmental procurement support ; logistical support for shipping and travel; field-site evaluation and selection; subject recruitment and follow-up; biological or environmental sample collection/accessioning/storage; laboratory characterization of collected samples; data management and analysis;

translation services to and from English; report generation; and manuscript preparation. A close working relationship, via sub-contract, agreement or other appropriate vehicle may also be required with numerous entities including, but not limited to, regional academic institutions and local health care facilities, as well as with foreign governmental institutions such as Ministries of Health, Ministries of Defense, Environmental and Wildlife Ministries. Additional details for each of the study categories are provided below:

C.6.1 Disease Surveillance and Epidemiology

Support is required on a variety of disease surveillance and related epidemiology activities; including but not limited to retrospective and prospective epidemiology studies, active disease surveillance studies, as well as cohort and cross-sectional studies.

C.6.2 Evaluation of Novel Diagnostics, Therapeutic Interventions, and Vector Control Strategies

Support is required for studies aimed at evaluating the performance of – yet to be determined – novel disease diagnostics, therapeutic interventions, and disease vector control strategies. Focus will be on advanced development and evaluation of commercially available products for the benefit of public health and military force health protection.

C.6.3 Disease Ecology

Support is required for studies aimed at elucidating the ecological relationships between disease pathogens and the environment. The principal goal of these studies is to understand the environmental conditions that are permissive to pathogen emergence and the characterization of the necessary and/or sufficient factors that increase the risk of transmission. Identification of such risk factors may point to potential mitigation strategies for disease control and identification of hazards for deploying forces.

C.6.4 Capacity Development and Training

Support is required for the development of regional capacity to detect and safely respond to emergent disease threats. It is envisioned that capacity development will take the form of targeted and distinct training topics.

Examples of such training include but are not limited to Biosafety/Biosecurity Training, Field Diagnostics Training, and Epidemiological Investigation Training.

C.7 Travel and Other Direct Costs (ODCs)

C.7.1 Travel

There may be travel required in performance of this contract. Travel costs will be estimated with a not to exceed (NTE) amount provided by the Government. Specific travel destinations, traveler(s), dates of travel, and estimated travel costs will be identified at the task order level, but will primarily be to visit field surveillance and research laboratory sites, and attend trainings and meetings with foreign liaisons throughout the SEA region. Any identified task order travel requirements need to be approved by the COR in writing (i.e., email) before embarking. Travel costs may include MEDEVAC and repatriation insurance. All travel shall be conducted in accordance with the DoD JTR and US Department of State (DoS) regulations.

C.7.2 ODCs

There may be ODCs required in performance of this contract. ODCs will be estimated with a not to exceed (NTE) amount provided by the Government. ODCs will be specified at the task order level, but will typically include (but are not limited to) contractor-procured supplies, equipment, disposable and non-disposable items, IT support and equipment..

C.8 Labor Categories Qualifications:

The uniqueness of this requirement is that one of two parts is performed by the contractor overseas, specifically in SEA (FOREIGN as opposed to OCONUS). That is, there will be foreign nationals performing against this contract in their host nations. The expectation is that services in support of field surveillance and laboratory analysis conducted in-country by foreign nationals will be itemized and addressed at the task order level as those projects develop.

The second part, though CONUS-based, includes program management and research support services for the overseas part, also being unique in scope (OCONUS). Support for this element is represented by the anticipated labor categories below:

C.8.1 Program Manager:

a. Description: The Program Manager (PM) is responsible for providing overall administrative and management oversight in order to maximize the effective use of program resources. PM will coordinate corporate support for research program functions and activities with NMRC-A leadership and the in-country Project Manager(s). PM will also assist in defining and determining personnel, budgets, and facilitating the establishment of agreements with in-country collaborators and subcontractors to initiate foreign research projects.

b. Location: US-based

c. Qualifications: This position requires the equivalent of a college degree in Human Resources Management, Business Administration, or science-related field plus 4 to 6 years of experience supporting US military medical research programs. Equivalent of an advanced degree is preferred but not required.

C.8.2 Project Manager:

a. Tasks: The Project Manager will coordinate in-country activities for specific projects, ensuring that all resources, including foreign national labor and subcontractor staff, are maximized effectively. Along with the Program Manager, the Project Manager will interface directly with NMRC-A leadership and principal investigators to establish agreements with in-country collaborators and subcontractors, and will manage activity personnel and project budgets.

b. Location: May be US-based with travel indicated to country of operation and NMRC-A

c. Qualifications: Knowledge of human resources practices, laws, and approaches. Knowledge of budgets and accounting. Ability to interface with investigators, vendors, research staff, and in-country partners.

Bachelor’s degree required. Knowlede of local language and customs prefereble.

C.8.3 Finance & Accounting Specialist:

a. Description: This position will prepare financial data for monthly reports, advise the Project Manager on cost issues, and provide overall cost data analysis for NMRC-A research program support.

b. Location: US-based

c. Qualifications: Knowledge of government contracts, finances, invoice preparation, and general accounting tasks. Ability to interface with investigators, vendors, research staff, and USG finance personnel. A college degree in business administration, accounting, or related field plus 2-4 years of related experience is required. An advanced degree is preferred but not required.

C.8.4 Project Assistant/Contracts Specialist:

a. Description: This position will coordinate and execute all contract documentation, including subcontracts and agreements with foreign in-country collaborators, in accordance with the NMRC-A research project objectives.

b. Location: US-based

c. Qualifications: A college degree in business administration, contract management, or related field plus 2-4 years of related experience is required. An advanced degree is preferred but not required. Must have knowledge of/experience with establishing agreements and subcontracts with foreign entities.

C.8.5 Host Nation Staff:

a. Tasks: In-country staff support will be needed to assist in the facilitation of project execution and liaising with collaborator and subcontractor personnel. This position may also provide translation support as needed.

b. Location: In country of research project performance or at NMRC-A, Singapore with significant travel indicated to country of performance.

c. Qualifications: Bachelor’s degree in a science-related field required, with experience supporting clinical research and knowledge of informed consent. Working knowledge of local language preferred.

C.8.6 Biostatistician:

a. Tasks: This position will provide statistical support for evaluation/research studies, including study design, sample size estimation, participant randomization, statistical analyses, and interpretation of data.

b. Location: NMRC-A, Singapore

c. Qualifications: A Master’s degree in biostatistics, mathematics, or a related field, with knowledge of SAS programming is required.

C.8.7 Epidemiologist:

a. Tasks: This position will work with NMRC-A researchers to conduct data analyses and interpret biosurveillance findings to assist in the development of conclusive research reports related to epidemiological studies. The epidemiologist may also advise on outbreak investigations and response plans in collaboration with in-country research partners.

b. Location: NMRC-A, Singapore

c. Qualifications: Master’s degree in public health or related field, with 3 years of epidemiological research required. Prefer Ph.D. or M.D. with training and degree in epidemiology.

C.8.8 Field Operations:

a. Tasks: This position will be optimized for infectious disease research assistance at field sites within NMRC-A countries of operation. Anticipated tasks may include obtaining specimens (e.g. blood draws, respiratory swabs, etc.), administering informed consent, and working with in-country partners to carry out research protocols at hospitals and remote villages.

b. Location: In country of research project performance or at NMRC-A, Singapore with significant travel indicated to the country of performance.

c. Qualifications: Bachelor’s degree with 2 years of experience in medical technology or clinical research field required. Ability to be trained in proper throat, urine, and blood collection techniques.

Working knowledge of local language preferable.

C.8.9 Database Specialist:

a. Tasks: This position is responsible for evaluating and analyzing database systems used by NMRC-A to determine and develop solutions to better support researchers, especially in the area of data entry.

The Database Specialist may also provide data entry support for NMRC-A researchers.

b. Location: NMRC-A, Singapore

c. Qualifications: Bachelor’s degree in computer science or related field with knowledge of database management and data entry required

C.9 Data Deliverables

C.9.1 Contractor Progress, Status, and Management Report (CDRL# A001). The Contractor shall provide monthly/quarterly status reports for each individual task order in Contractor format by the 10th working day of each month/quarter to the COR and Contracting Officer (KO). This status report shall include, at a minimum, an executive summary roll-up of all contract efforts to include initiatives and efforts to date, planned tasks and travel for the next reporting period, projected overtime if approved by the KO, and concerns or issues related to performance as they relate to the PWS for this task.

C.9.2 Technical Report – Study/Services (CDRL# A002). The contractor shall provide a final technical report no later than thirty days after expiration of the task order. This final report shall include, at a minimum, a comprehensive summary of technical accomplishments and issues, if any, made during the course of the task order performance. To be applied at the task order level – not required for the base contract.

C.9.3 Lab/Data/Surveillance Reports (CDRL# A003). The contractor shall provide periodic technical data reports related to specific studies in which data output is required to be generated, such as the results of disease surveillance findings for a period of time. IRB/Human Research Protection Program (HRPP) documentation, such as approved protocols, approved informed consent forms, and assurance documentation is considered a data item under this CDRL when required to furnish. To be applied at the task order level – not required for the base contract.

C.10 SECURITY REQUIREMENTS

C.10.1 DD254

Specific task orders issued under this contract may require personnel to have access to classified information. This contract will therefore include a DD254 at the SECRET level. Specifics regarding security classification will be handled at the task order level. The basis for need will be for the purpose of attending Department of State (DoS) or US Embassy-based meetings containing DoS/DoD sensitive information. Contractor employees, regardless of security classification requirement, are expected to comply with any onboarding procedures required by NMRC-A and/or the US Embassy, Singapore.

C.11 Common Access Card (CAC)

In the event a specific task order requires contractor personnel to obtain a CAC for access to a DoD IT network and email address, but does not require SECRET clearance for that particular task order, a National Agency Check will be required prior to onboarding those personnel.

Section D - Packaging and Marking

All deliverables required under this contract shall be packaged, marked and shipped in accordance with best commercial practice. At a minimum, all deliverables shall be marked with the contract number and contractor name.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination N/A Destination Government 0002 Destination Government Destination Government 0003 Destination N/A Destination Government 0004 Destination N/A Destination Government 0005 Destination N/A Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-4 Inspection Of Services--Fixed Price AUG 1996 52.246-5 Inspection Of Services Cost-Reimbursement APR 1984 52.246-7 Inspection Of Research And Development Fixed Price AUG 1996 52.246-8 Inspection Of Research And Development Cost

Reimbursement

MAY 2001

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 POP 26-SEP-2016 TO

27-SEP-2018

N/A N/A

0002 POP 26-SEP-2016 TO

27-SEP-2018

0003 POP 26-SEP-2016 TO

0004 POP 26-SEP-2016 TO

0005 POP 26-SEP-2016 TO

52.242-15 Stop-Work Order AUG 1989

Section G - Contract Administration Data

252.204-7000 Disclosure Of Information AUG 2013

CLAUSES INCORPORATED BY FULL TEXT

252.204-0002 LINE ITEM SPECIFIC: SEQUENTIAL ACRN ORDER. (SEP 2009)

The payment office shall make payment in sequential ACRN order within the line item, exhausting all funds in the previous ACRN before paying from the next ACRN using the following sequential order: Alpha/Alpha;

Alpha/numeric; numeric/alpha; and numeric/numeric.

(End of clause)

ACC-APG NCD 5152.232-7003 INVOICING INSTRUCTIONS AND PAYMENT

(WAWF INSTRUCTIONS) (NCD) (AUG 2009)

(a) Invoices for goods received or services rendered under this contract shall be submitted electronically through Wide Area Work Flow – Receipt and Acceptance (WAWF):

(1) The vendor shall self-register at the web site https://wawf.eb.mil. Vendor training is available on the Internet at https://wawftraining.eb.mil/wbt/

(2) Select the invoice type within WAWF as specified below. Back up documentation (such as timesheets, etc.)

can be included and attached to the invoice in WAWF. Attachments created in any Microsoft Office product are attachable to the invoice in WAWF. Total limit for the size of files per invoice is 5 megabytes.

(b) The following information, regarding invoice routing DODAAC’s, must be entered for completion of the invoice in WAWF:

For CPFF Task Orders:

Cost Voucher (T&M – LH – Cost) Pay DoDAAC To be provided at time of award Issue By DoDAAC W911QY Admin DoDAAC To be provided at time of award DCAA Auditor DoDAAC

To be provided at time of award

Service Approver N62814 LPO (For Navy Only) N62814

For FFP Task Orders:

Invoice as 2-in-1 (FFP Services Only) Pay DoDAAC To be provided at time of award Issue By DoDAAC W911QY Admin DoDAAC To be provided at time of award https://wawf.eb.mil/ https://wawftraining.eb.mil/wbt/

DCAA Auditor DoDAAC

To be provided at time of award

Service Approver N62814 LPO (For Navy Only) N62814

(c) The contractor shall submit invoices /cost vouchers for payment per contract terms.

(d) The Government shall process invoices /cost vouchers for payment per contract terms.

(e) For each invoice /cost voucher submitted for payment, the contractor shall also email the WAWF automated invoice notice directly to the following points of contact:

Name Email Phone Job Title Jason Borja Jason.p.borja.ctr@mail.mil 619-553-5877 Acquisition Specialist (CONT) LT Johnathan Ward Johnathan.ward@fe.navy.mil 656-751-2203 Contracting Officer’s

Representative (COR) Richard Totten Richard.w.totten2.civ@mail.mil 301-619-2446 Contracting Officer

COR

CONTRACTING OFFICER’S REPRESENTATIVE

(a) For the purpose of this clause, the Contracting Officer’s Representative (COR) is the duly authorized representative of the Contracting Officer.

(b) The COR for this contract will be appointed prior to award.

(c) The COR will perform inspection and acceptance of services to be provided. Inspection and acceptance will be performed at the locations listed in Section C of the contract.

(d) The COR for this contract is:

• LT Johnathan Ward

• Naval Medical Research Center – Asia

• (656) 751-2203

• Johnathan.Ward@fe.navy.mil mailto:Jason.p.borja.ctr@mail.mil mailto:Johnathan.ward@fe.navy.mil mailto:Richard.w.totten2.civ@mail.mil mailto:Johnathan.Ward@fe.navy.mil

Section H - Special Contract Requirements

H.1 Area of Responsibility (AOR)

(a) The Offeror must have a local system or process that tracks the hours of each of its contract personnel relative to a specific Task Order and CLIN that is being direct charged against the contract (similar to DCAA guidelines concerning timesheets). Also, if any overtime is required, then both base hours and overtime hours need to be traceable and auditable.

(b) Performance in-country requires observance of the local workweek and national holidays, in addition to US national holidays that are observed by the embassy.

(c) The fringe benefits and the recovery of fringe benefits (particularly, vacation) may differ than what a Federal contractor in the United States is familiar with. The contractor must be able to track usage of vacation so that a double billing does not occur.

(d) Contractor is to be familiar and compliant with in-country laws concerning foreign national employees and companies working within the specific country of performance.

(e) Contractor is to be knowledgeable and compliant with US State Department requirements and, when applicable for US citizens, Department of Labor requirements, as well as any foreign country labor requirements.

H.2 Security Requirements

(a) DD254: Specific task orders issued under this contract may require personnel to have access to classified information. This contract will therefore include a DD254 at the SECRET level. Specifics regarding security classification will be handled at the task order level. The basis for need will be for the purpose of attending Department of State (DoS) or US Embassy-based meetings containing DoS/DoD sensitive information. Contractor employees, regardless of security classification requirement, are expected to comply with any onboarding procedures required by NMRC-A and/or the US Embassy in the SEA country of operation.

(b) Common Access Card (CAC): In the event a specific task order requires contractor personnel to obtain a CAC for access to a DoD IT network and email address, but does not require SECRET clearance for that particular task order, a National Agency Check will be required prior to onboarding those personnel (Department of the Navy security IT Level II).

H.3 Individual Task Orders

(a) Each Task Order awarded under this contract will have its own PWS to perform some or all of the above noted tasks in the NMRC-A AOR. Task Order PWSs will be specific as to descriptions of work to be performed, duration of work to be performed, and location of work to be performed under each Task Order.

(b) This contract will accommodate both severable and non-severable Firm-Fixed-Price (FFP) and Cost-Plus-Fixed- Fee (CPFF) type task orders (CPFF being dependent upon the contractor possessing an acceptable accounting system with DCAA-approved indirect rates). Upon ordering, CPFF type task orders will be deemed either completion or term form. The completion form describes the scope of work by stating a definite goal or target and specifying an end product (e.g., a final report of research accomplishing a goal or target) such that completion of the goal, target, or end product is necessary in order for the Government to successfully receive such benefit. The term form describes the scope of work in general terms and obligates the contractor to devote a specified level of effort for a stated period of time. A term or level of effort may have monthly and final reports (as per the CDRLs) but completion of such reports does not prohibit the Government from successfully receiving the benefit. The term form is not a time and material type contract or fixed labor rate contract in this context. In accordance with FAR 52.232-20—Limitation of Cost, for completion-form CPFF task orders, the contractor will be required to notify the Contracting Officer if the total cost for performance will be either greater or substantially less than previously estimated. In the case of the latter, the Contracting Officer may negotiate total fee downward to be commensurate with actual work performed.

(c) The Government expects to issue approximately five (5) task orders upon initial contract award. Descriptions of these task orders can be found within Appendix A of this solicitation.

H.4 Accommodation of Different Funding Sources

It is anticipated that individual task orders may need to accommodate more than one source and type of funding, which is allowable if intended for the same purpose. For example, a task order may support a study with two separate but complementary phases, with each phase funded by a different ‘color’ of money but still contributing to the same overall study purpose, as is usually the case when a field-based biosurveillance/clinical portion of work (typically funded by Operations & Maintenance (O&M)) is complemented by a laboratory-based diagnostics/etiological portion of work (typically funded by Research and Development (R&D)).

H.5 Non-personal Services

Personal services will not be provided under this contract; all services will be non-personal in nature. For CPFF-type task orders, non-personal services may include contractors driving US Embassy or NMRC-A vehicles off compound, which is allowable and not considered a personal service when performed incidentally due to special circumstances while located OCONUS/Foreign. Driving tasks may include (but are not limited to) driving to research field sites, laboratories, meeting places, training locations, or shuttling passengers for official business on behalf of the command (vice personal errands or requests, which would be considered a personal service).

Reference US Department of State Foreign Affairs Manual, Section 14 Part 430, “Managing Official Vehicles at Posts Abroad” and DoD 4500.36-R, “Management, Acquisition, and Use of Motor Vehicles.”

An exception to this non-personal services requirement is, for example, when the local command has set up an established driver and van to escort US personnel from their off-base quarters to command facilities.

H.6 Invention Disclosures and Reports

In accordance with the requirements of the Patent Rights clause of this contract, the contractor shall submit “Report of Inventions and Subcontracts” (DD Form 882) along with written disclosure of inventions to the designated Contract Administrator.

The Contract Administrator will forward such reports and disclosures directly to the appropriate Patent Counsel, designated below, for review and recommendations, after which the reports will be returned to the Contract Administrator.

Name and address of Patent Counsel: To be provided at time of award.

The above designated Patent Counsel will represent the Procurement Contracting Officer with regard to invention reporting matters arising under this contract.

A copy of each report and disclosure shall be forwarded to the Procuring Contracting Officer.

The contractor shall furnish the Contracting Officer a final report within three (3) months after completion of the contracted work listing all subject inventions or certifying that there were no such inventions, and listing all subcontracts at any tier containing a patent rights clause or certifying that there were no such subcontracts.

The contractor may submit a DD Form 882 at any time during performance of the contract in addition to the requirement in section (e) above if they deem it necessary to protect intellectual property of the contractor company, the contractor employee, or the government employee.

H.7 Performance by Foreign Nationals or Foreign Ownership, Control or Influence (FOCI) Organizations

In accordance with 8 U.S.C.1324a, it is unlawful to hire for employment in the U.S. an individual without verifying that individual’s employment authorization. 8 CFR 274a.2 VERIFICATION OF EMPLOYMENT ELIGIBILITY identifies the official documents that establish employment eligibility.

Prior to performance of work by a foreign national as a result of this contract, the employer shall provide the Contracting Officer the name of the foreign national and identify the type of form(s) produced for verification of employment status.

Should the foreign national’s performance require access to DoD facilities, the employer shall coordinate with the sponsor providing access, in order to submit the following:

1. Individual’s Name

2. Date/place of birth

3. Citizenship

4. Date and Location of the Visit

5. Purpose of the Visit

6. Passport Number

Employer’s Verification of Work Authorization. This information shall be forwarded to the Contracting Officer at least thirty days prior to the visit taking place. Failure to provide this information within this time frame may prevent the individual(s) from entry into the DoD facilities.

The Offeror shall disclose if the company (or individual) is a Foreign Ownership, Control or Influence (FOCI) organization. A FOCI organization includes sole proprietorships, partnerships, and corporations, and the divisions and subsidiaries of the corporation where: (a) 51% or more of the controlling (voting) stock is foreign-owned; or

(b) parent organization is incorporated or otherwise charted in a country foreign to the U.S.; and (c) the organization is not performing a state function (any organization performing a state function falls under IPO authority). A division or subsidiary of an organization having a location in the U.S. is still considered FOCI if the parent corporation is a FOCI. A university, college, or not-for-profit organization that is chartered, incorporated, or otherwise called into being in a country foreign to the U.S. and not performing a state function is FOCI. A FOCI person is a non-U.S. citizen. Resident aliens are considered FOCI for licensing and technology transfer purposes.

Approval by the U.S. Trade Representative may be required prior to executing a contract with a FOCI. If the foreign national has dual citizenship that includes U.S. citizenship, then such individual shall be processed as a Representative of Foreign Interest (RFI). Reporting requirements above to the Contracting Officer and the Army Foreign Disclosure Office/Authority apply to RFIs.

H.8 Protection of Human Subjects

All research involving human subjects shall be conducted in accordance with 32 CFR 219 “The Common Rule”, USC 980 “Limitation on Use of Humans as Experimental Subjects”, DoDI 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” SECNAVINST 3900.39D Department of the

Navy (DON) Human Research Protection Program (HRPP), and Federal Acquisition Regulation (FAR) 252.235-7004 Protection of Human Subjects, which is included in full text within Section I, Contract Clauses. Offerors must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations, recruitment of military research subjects, and informed consent and surrogate consent and chemical and biological agent research. Food and Drug Administration (FDA) regulation and policies, especially as they relate to the use of investigational new drugs/devices (IND) in research may also apply. The contractor shall also comply with all training requirements directed by the command Institutional Review Board/ Human Research Protection Program (HRPP) Administrator and DON HRPP. Any human subjects research performed or supported by non-DoD (contractor) personnel under this contract will need to be approved by the cognizant DON Human Research

Protection Official (HRPO) prior to beginning work. Individual task orders supporting human subjects research will be identified as such within the task order SOW/PWS prior to issuance of the task order and will require HRPO review. Those task orders not supporting human subjects research will thus not require HRPO review.

The cognizant HRPO for NMRC-A is:

LCDR Tyler Warkentien Naval Medical Research Center – Asia 65-6751-2204

H.9 Authorized Changes Only by the Contracting Officer

Except as specified below, no order, statement, or conduct of Government personnel who visit the contractor’s facilities or in any other manner communicates with contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

H.10 Review of Press Releases

The contractor agrees to accurately and factually represent the work conducted under the contract in all press releases. Misrepresenting contract results or releasing information that is injurious to the integrity of the Government may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer has received an advance copy of any press release related to the contract for review and comments in accordance with DFARS clause 252.204-7000 prior to proposed issuance. After receipt of the Government’s comments, the contractor shall provide a copy to the Contracting Officer prior to issuance of the press release. Review by the Government includes the public affairs offices of both ACC-APG NCD and NMRC- A.

H.11 Research Conduct

Research provided under this contract must be conducted in accordance with all state, federal, Department of Defense, Department of the Navy, and command laws, regulations, policies, and procedures that govern the conduct of regulated research. Federal regulations governing current Good Clinical Practice (cGCP) are found in 21 CFR 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice are also standards governing the conduct of research trials.

This is a non-personal services contract for research and development. The Federal Tort Claims Act does not apply.

Therefore, indemnification of the Government by the contractor and medical liability insurance shall be in place before any human subject/patient treatment is…