RFP-NIAID-DMID-NIHAI2016065.pdf

Attachment 1 – Packaging and Delivery of Proposals Page 1 of 3

RFP-NIAID-DMID-NIHAI2016065

ATTACHMENT 1 – PACKAGING AND DELIVERY OF PROPOSALS

I. PROPOSAL SUBMISSION

A. eCPS

1. The National Institute of Allergy and Infectious Diseases (NIAID) requires proposals to be submitted via its electronic Proposal Submission System (eCPS)

2. Submission of proposals by facsimile or e-mail is not acceptable.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/NIAID/home/howto. Please note that creating an account to submit can take up to three (3) business days. Please register early to allow enough time for the registration process.

4. Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal”, in accordance with FAR Clause 52.215- 1 Instructions to Offerors – Competitive Acquisition.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. The Business Proposal must be comprised of the following files:

a. The first file must be a PDF of your Business Proposal, with all attachments, including the Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.” The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned and merged into the Business Proposal PDF file.

b. The remaining file(s) should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF.

Multiple Excel files may be included, as necessary.

3. Each of the proposals, Technical and Business, must be separate and complete in itself, so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

4. File naming convention: It is required that the filenames for both your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number, and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf https://ecps.nih.gov/ https://ecps.nih.gov/NIAID/home/howto

Attachment 1 – Packaging and Delivery of Proposals Page 2 of 3

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

2. Font size must be 10 to 12 points.

3. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

4. Margins must be at least one-inch on all sides.

5. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in entirety.

B. Page limitations:

1. Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section.

2. Pages in excess of this limitation will be removed from the proposal and will not be considered.

NUMBER OF COPIES AND APPLICABLE PAGE LIMITATIONS

Document Number of Copies

Page Limits

Technical Proposal

ONLINE (using the eCPS website) One (1)electronic copy of the Technical Proposal (including all Attachments)

Not to Exceed 200 pages (inclusive of all Attachments, with the exception of the Standard Operating Procedures referenced in the Additional Technical Proposal Instructions. CV’s are not to exceed 3 pages.)

Business Proposal

ONLINE (using the eCPS website) One (1) submission containing two files, as instructed below.

1. One (1) electronic PDF copy of the

Business Proposal (with all Attachments including the PDF rendering of the Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet).

N/A http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

Attachment 1 – Packaging and Delivery of Proposals Page 3 of 3

2. One (1) Electronic Cost Proposal Excel

Workbook See Solicitation Section J, Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

ATTACHMENT 2

Attachment 3 – Statement of Work Page 1 of 10

ATTACHMENT 3: STATEMENT OF WORK

NIAID DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES:

CLINICAL MATERIALS SERVICES

BACKGROUND AND INTRODUCTION

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, diagnostics and devices, which is funded through a variety of research grants and contracts.

The evaluation of new and improved vaccine, therapeutic, diagnostic and device candidates in clinical trials and clinical studies is an essential element of DMID’s efforts. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, and Phase 4 (and occasionally Phase 3) clinical trials for the evaluation of bacterial, viral and parasitic vaccines, other biologics, drugs, diagnostics and devices as preventive, therapeutic, and diagnostic measures against infectious diseases in people of all ages and risk categories. Much of this clinical research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases, including avian influenza and anti-microbial resistance, and those supporting the evaluation of safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm).

In August 2008, NIAID awarded a 7-year contract to Fisher BioServices Corporation (HHSN272200800044C) to provide for the operation of a Clinical Agent and Specimen Repository (CASR) that adheres to current Good Manufacturing Practice (cGMP), for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID-sponsored clinical trials and research programs in the U.S. and abroad.

Clinical agents include investigational study products (drugs, vaccines, therapeutics, diagnostics and devices), commercial products, placebos, syringes, and other protocol/Manual of Procedures (MOP)-mandated supplies to be used in DMID-sponsored clinical trials. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-approved clinical research sites, to be distributed or tested at DMID-approved testing laboratories.

Samples and data will be transferred to any awardee resulting from this solicitation as part of initial transition activities. NIAID recognizes that a single organization or institution may not have the expertise and facilities required to perform all of the activities set forth in the Statement of Work and, consequently, that the Contractor may need to be supported to a certain extent by the expertise and resources of subcontractors to perform some of the tasks required. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractor(s).

Attachment 3 – Statement of Work Page 2 of 10

SCOPE

This contract is for the management and operation of a cGMP-compliant clinical materials services (CMS) facility, including receipt, storage, aliquoting, labeling, packaging, repackaging, shipping, acquiring, testing, and disposition of clinical agents and clinical specimens. All work performed under this contract must be done in compliance with federal and/or local clinical trial related regulations.

TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work as stated herein. Specifically, the Contractor shall:

A. CLINICAL AGENTS

1. Receipt and Storage of Clinical Agents

The Contractor shall receive and store clinical agents from product suppliers as follows:

a. Develop and maintain an electronic clinical agent shipping request form to track and inventory clinical agents shipped to the CMS facility.

b. Upon receipt of a clinical agent shipping request, confirm the regulatory status of the clinical agent. Provide suppliers with written instructions for appropriate shipping and handling to arrange for regulatory compliant shipments.

c. Obtain all required import permits and authorizations for receiving, storing and distributing clinical agents.

d. Perform and document inspection of shipments received and resolve any discrepancies or problems that arise.

e. Track and record contents and condition of each shipment. Electronically document chain of custody, shipment receipt date, condition and results of inspection of clinical agents and shipments.

f. Verify the inclusion of DMID-approved product information document (e.g. Certificate of Analysis (CoA)) with each shipment of clinical agents. Perform and document a review of each CoA and resolve any discrepancies or problems that arise.

g. Store clinical agents at temperatures and conditions indicated by the manufacturer. Monitor and document storage conditions to ensure they are consistently maintained for the duration of storage.

2. Labeling, Packaging and Repackaging Clinical Agents

The Contractor shall label, package and/or repackage clinical agents for distribution to DMID-approved clinical research sites and DMID-approved testing laboratories as follows:

a. Develop an electronic request form for use in review and approval of requests from DMID-approved clinical research sites for labeling, packaging and repackaging of clinical agents.

b. Generate appropriate labels for each clinical agent in compliance with federal and local labeling requirements. Affix approved labels to each clinical agent.

c. Maintain a stock of packaging necessary to comply with protocol requirements.

Attachment 3 – Statement of Work Page 3 of 10

d. Provide and maintain the necessary clean room(s) and equipment for packaging and repackaging of clinical agents, as well as facility space to label under cold chain conditions in compliance with cGMP.

3. Shipping Preparation Procedures and Equipment for Clinical Agents

The Contractor shall use appropriate shipping and packaging procedures and equipment as follows:

a. Provide validation testing of the procedures for the packaging and shipping of clinical agents within 10 business days of receipt of request. Testing must validate appropriate temperatures and conditions as required by the U.S. Pharmacopeia (USP) and compliance with any other agent-specific regulations or requirements.

b. Prepare shipments of clinical agents for domestic and non-domestic DMID-approved clinical research sites and DMID-approved testing laboratories.

4. Shipping and Distribution of Clinical Agents

The Contractor shall ship and distribute clinical agents to DMID-approved clinical research sites and DMID-approved testing laboratories as follows:

a. Prior to processing and shipping a clinical agent request, verify and document the following:

i. Availability of inventory for release

ii. Request approval by COR

iii. Appropriate and current import/export permits

iv. Receipt of regulatory documents by DMID

v. Site approval for the initiation of the clinical trial for DMID-approved clinical research sites.

vi. For international shipments, within 2 days of the request, the facility needs to let the COR know a) what information is required from DMID; and b) the expected timeline for shipment.

b. Ship clinical agents to DMID-approved domestic and non-domestic clinical research sites and

DMID-approved testing laboratories ensuring that domestic shipments are received within 24 hours and international shipments within 3-5 calendar days.

c. Safely deliver clinical agents at temperature and conditions specified in the protocol.

d. Remotely monitor temperature of clinical agents during transit and evaluate data to ensure shipping has been completed within product specifications. Identify and resolve any discrepancies that arise.

e. Provide emergency shipments upon request outside of normal hours of operation in the event of a public health emergency.

5. Documents and Regulations for Shipping Clinical Agents

The Contractor shall obtain and maintain all required permits and authorizations to comply with domestic and non-domestic laws and regulations for shipping and distribution of clinical agents as follows:

a. Generate and obtain all required shipping documents, including: U.S. Department of

Agriculture permits, FDA Investigational New Drug Application (IND) Number assignment, pro forma invoices, letters of donation, Material Transfer Agreements, Clinical Trial Agreements, Clinical Materials Supply Agreements, Certificates of Authenticity (CoAs), Attachment 3 – Statement of Work Page 4 of 10 commercial invoices, Material Safety Data Sheets (MSDS) and Certificates of Pharmaceutical Product.

b. Research the regulations and documents required for shipment of clinical agents to non-domestic countries, and maintain a listing of this information for all countries with DMID-approved clinical research sites. This listing shall be regularly updated by the Contractor and information shall be provided to the COR and other DMID staff upon request.

c. Ensure that all required import and export permits have been received from non-domestic DMID-approved clinical research sites, the shipping agent retained by the DMID-approved clinical research sites, the embassies of those countries, and the customs offices or other pertinent offices of those countries, prior to processing shipments. All import and export documents must be maintained on file at the CMS for the life of the contract.

d. Collaborate with the courier service in providing assistance to non-domestic clinical research sites for obtaining necessary import, export, customs and tax exemption documents.

e. Obtain and maintain appropriate licenses and permits required by local, state, province, domestic, and non-domestic, country-specific government authorities for the safe import, storage, handling, transportation, and distribution of drugs, biologics, controlled substances and devices. Process any document requiring embassy approval through the appropriate embassy. Obtain the appropriate interstate, intrastate and non-domestic import/export shipping licenses and permits for transporting drugs, biologics, controlled substances, and devices.

6. Tracking and Inventory Management of Clinical Agents

The Contractor shall track and inventory clinical agents as follows:

a. Maintain an electronic inventory management system to track, code, and archive information on all clinical agents received, acquired, stored and shipped to and from the CMS including the following information:

vii. Identity of clinical agent

viii. Manufacturer/source of clinical agent

ix. Source point of contact

x. Quantity received

xi. Storage location

xii. Quantity shipped

xiii. Shipping request

xiv. DMID-approved clinical research site or DMID-approved testing laboratory

xv. Protocol number

xvi. Expiration and retest dates

b. Monitor monthly clinical agent use rate documenting low inventories, upcoming expiration or retest dates and notable increases or decreases in amount shipped to DMID-approved clinical research sites and DMID-approved testing laboratories.

c. Perform routine physical inventories of all clinical agents held at the CMS. Identify and document any discrepancies that cannot be reconciled with the current computerized inventory.

d. Monitor all shipment data to capture protocol, clinical agent, lot number, recipient Clinical Principal Investigator, shipment date and clinical research site or testing laboratory.

7. Quarantine and Final Disposition of Clinical Agents

The Contractor shall quarantine and dispose of unused, expired, and/or recalled clinical agents upon request in accordance with 21 CFR 211.204 as follows:

Attachment 3 – Statement of Work Page 5 of 10

a. Establish an onsite final disposition program that meets all U.S. and local public and occupational health, safety and environmental protection regulations.

b. Provide all applicable special handling instructions to DMID-approved clinical research sites for the return of clinical agents to the CMS.

c. Receive recalled, expired or unused clinical agents returned from DMID-approved clinical research sites. Process returns in compliance with local, state and U.S. regulations.

d. Move clinical agents to quarantine when clinical agents have been recalled or are no longer to be shipped to DMID-approved clinical research sites, as well as all returned and expired products.

e. Upon COR request, dispose of returned clinical agents in accordance with local, state, and U.S. regulations.

8. Acquisition and Testing of Clinical Agents

The Contractor shall acquire clinical agents required for the implementation of DMID-funded clinical trials, and perform non-clinical testing on the acquired clinical agents as follows:

a. Acquire clinical agents manufactured in compliance with cGMP regulations.

b. Test acquired clinical agents as outlined in Federal Regulations 21CFR610 and 21CFR211 upon request. Provide for additional in vitro and in vivo safety testing of acquired clinical agents as required on a case-by-case product-specific basis.

B. CLINICAL SPECIMENS

1. Receipt and Short Term Storage of Clinical Specimens

The Contractor shall receive clinical specimens from DMID-approved clinical research sites and provide short-term storage of clinical specimens in support of DMID-approved clinical research as follows:

a. Develop an electronic clinical specimen shipping request form for use when DMID-approved clinical research sites ship clinical specimens to the CMS.

b. Upon receipt of a clinical specimen shipping request to provide short-term storage of clinical specimens, provide instructions for shipping and handling of clinical specimens to DMID-approved clinical research sites to preserve specimen integrity and utility including labeling, storage and shipping requirements for compliance with all domestic and non-domestic laws and regulations.

c. Receive shipments of clinical specimens from domestic and non-domestic DMID-approved clinical research sites.

d. Perform and document inspection and verification of all incoming shipments at the vial level.

Identify and reconcile any discrepancies or problems that arise.

e. Track and record contents and condition of the shipments. Electronically document chain of custody, shipment receipt date, condition and inspection of specimens and shipments, storage and monitoring of clinical specimens from DMID-approved clinical research sites.

f. Store clinical specimens at temperatures and conditions indicated by the documentation provided with the specimens. Monitor and document conditions to ensure they are consistently maintained for the duration of storage.

Attachment 3 – Statement of Work Page 6 of 10

2. Aliquoting and Labeling of Clinical Specimens

The Contractor shall aliquot and label clinical specimens received from DMID-approved clinical research sites as follows:

a. Provide and maintain the necessary clean room(s) and equipment for the aliquoting and labeling of clinical specimens.

b. Aliquot and label clinical specimens for distribution in appropriate containers upon request.

3. Shipping, Distribution and Testing of Clinical Specimens

The Contractor shall ship clinical specimens to DMID-approved testing laboratories in accordance with GLP and GCP regulations and in compliance with domestic and non-domestic laws and regulations as follows:

a. Package and ship components for safe, intact arrival of clinical specimens at temperature and condition specified in protocol.

b. Develop a clinical specimen receipt form to be sent to the DMID-approved testing laboratory for the verification of shipment receipt. This form shall be enclosed in all clinical specimen shipments and shall be returned to the Contractor to confirm receipt and arrival condition of clinical specimen.

c. Ship clinical specimens to DMID-approved testing laboratories for receipt within 24 hours for domestic shipments and within 3-5 calendar days for non-domestic shipments.

d. For international shipments, within 2 days of the request, the facility needs to let the COR know

a) what information is required from DMID; and b) the expected timeline for shipment.

e. Conduct testing of clinical specimens upon request of the COR.

4. Tracking and Electronic Inventory Management of Clinical Specimens

The Contractor shall track and inventory clinical specimens as follows:

a. Maintain an electronic inventory management system to track, code, and archive information on all clinical specimens received, stored, and shipped to and from the CMS including the following information:

i. Protocol number

ii. Specimen identification number

iii. Origination site

iv. DMID program

v. Date of receipt

vi. Number of units received

vii. Number of aliquoted units made

viii. Total number of units

ix. Storage location and storage condition within the CMS

x. Identity and destination of shipping requests

xi. Number of units shipped to each destination

b. Perform routine physical inventories of clinical specimens. Identify and document any discrepancies that cannot be reconciled with the current computerized inventory.

Attachment 3 – Statement of Work Page 7 of 10

5. Final Disposition of Clinical Specimens

a. Within 30 business days of the storage expiration date for clinical specimens at the CMS, provide e-mail notification to the COR.

b. Remove expired clinical specimens from active stock at the CMS and dispose of in accordance with local, state, and U.S. regulations.

C. OVERALL CONTRACT REQUIREMENTS

1. Security, Safety, Monitoring and Maintenance of Facilities and Equipment

The Contractor shall provide safe, secure facilities, monitored 24-hour a day, 7 days a week and equipment for the receipt, storage, quarantine, processing and distribution of clinical agents and clinical specimens that are compliant with cGMP and GLP. Maintain operating hours of 8:30 AM to 5:00 PM Eastern Standard/Daylight Time, Monday through Friday, except for official U.S.

Federal holidays. Establish procedures for emergency closings due to weather conditions or other unexpected closings mandated by local, state and Federal government authorities. Remain open during emergency closings upon request to support critical time-sensitive clinical research activities.

2. Electronic Information Systems, Data Management, and System Security

a. Electronic Information Systems

(i) Inventory Database Management System The Contractor shall maintain and operate an inventory database management system that captures the following features:

Archiving, tracking, and coding all clinical agents and clinical specimens received and stored at the CMS as well as all shipping requests for clinical agents and specimens.

Generation of integrated reports to sort data by various criteria.

Compatibility with information systems used by DMID and DMID clinical research support contractors to ensure accessibility of data.

(ii) Electronic Ordering System and Database Management System

The Contractor shall maintain and operate an integrated electronic ordering system and database management system to be used by DMID-supported investigators and staff and supplies to request shipping of clinical agents as follows:

Provide programming and IT user support for the database management system and the electronic ordering system.

Provide a semi-annual report on potential system modifications and improvements, and implement COR-approved system modifications and improvements.

Integrate the database management system and the electronic ordering system.

b. Data Management

The Contractor shall:

(i) Maintain the capacity and compatibility of the CMS database systems to access, receive, transmit, upload and download specific data from other DMID-owned data management systems.

Attachment 3 – Statement of Work Page 8 of 10

(ii) Ensure the effective and efficient coordination of data to complete specified functions in collaboration with the DMID Regulatory Affairs Support contractor, the DMID Clinical Research Operations Management (CROMS) Support contractor, and the DMID Statistical and Data Coordinating Center (SDCC) contractor. Functions include:

1) Receipt and storage of clinical agents requiring Investigational New Drug (IND) and

Investigational Device Exemption (IDE) Applications: Track regulatory information from the DMID Regulatory Affairs Support Database to verify regulatory status information for each DMID IND or IDE and to determine if the IND or IDE is effective and there are no clinical hold issues, prior to receipt of clinical agent from supplier.

2) Distribution of clinical agents under INDs and IDEs: Track to verify that DMID-approved clinical research sites have submitted all essential regulatory documents required for receiving clinical agents from the CMS and the sites have been approved to initiate clinical protocols, prior to shipping clinical agent to the DMID-funded clinical research sites.

3) Receipt, storage, and distribution of clinical specimens from the CMS to DMID approved testing laboratories: Utilize software to be provided by the SDCC contractor to barcode, scan, identify and track clinical specimens obtained from DMID-approved clinical research sites, prior to receiving or shipping clinical specimens.

c. System Security

The Contractor shall develop and implement approved validation processes and procedures to ensure the accuracy, completeness and integrity of data in the systems.

3. Training of CMS Personnel

The Contractor shall provide and mandate training for CMS personnel in order to safely perform the activities outlined in this Statement of Work as follows:

a. Provide and document completion of training regarding safety measures for handling clinical agents and clinical specimens; maintaining cold chain measures; receipt, storage, and shipping procedures; inventory procedures; labeling/randomization procedures; and final disposition of clinical agents and clinical specimens.

b. Provide and document completion of annual training of CMS personnel for facility security, fire drills, fire suppression system, cGMP, dry ice handling, use of personal protection and protection equipment, employee-monitoring-systems for use in walk-in freezers, and chemical spill clean-up procedures for all personnel with access to the CMS.

c. Provide and document completion of training for CMS personnel in the proper packing and use of validated shipping containers, on the use of standard forms and templates for letters and memoranda, and record keeping practices.

d. Review new Standard Operating Procedures (SOPs) with applicable staff and document by signature to verify that the review has occurred.

e. Provide and document completion of training to CMS personnel in the use of computer systems for databases and software systems required to meet the objectives and functions of the CMS.

f. Establish a regular forum to ensure that CMS personnel are informed and have the opportunity to:

i. Review new and revised SOPs;

ii. Obtain training on new and revised SOPs;

iii. Review established SOPs when breaches in procedures have occurred;

Attachment 3 – Statement of Work Page 9 of 10

iv. Identify protocol-specific issues;

v. Cross-train employees for prevention of impeded work flow;

vi. Brief staff on current issues; and

vii. Identify issues that need to be brought to the attention of the COR.

4. Quality Assurance/ Quality Control (QA/QC)

The Contractor shall develop and implement a Quality Assurance/Quality Control plan to standardize processes and ensure that the conduct of all CMS activities complies with cGMP regulations and meets the requirements of the contract.

5. Project Management

a. Meetings

The Contractor shall participate in the following:

i. Contract Initiation Meeting

ii. Weekly Progress Meetings or Teleconferences

iii. Annual Meetings

iv. Ad Hoc Meetings and Teleconferences

b. Site Visits and Audits

Arrange and conduct site visits and independent audits of Contractor and subcontractor facilities as needed or as requested by the COR, to evaluate compliance with domestic and non-domestic laws and regulations and FDA regulations and guidances, including those required to meet GLP, cGMP, and GCP standards, DMID policies, and the terms of the contract.

6. Final Transition

The Contractor shall design and implement an approved Final Transition Plan within 60 business days prior to the expiration of the contract. The Final Transition Plan shall provide for the efficient, orderly and safe transition of contract activities, data systems, documents and other information to the successor contractor or to the Government, without loss of time or interruption to the conduct of ongoing DMID-supported clinical research or clinical research in development.

1) Maintain full operational capacity until the expiration date of the contract, including implementation of the final transition and all necessary transition and closeout functions.

2) Provide a description of transition activities, timelines, and assigned staff in a Draft Final

Transition Plan and Final Transition Plan, which will be reviewed and approved by the COR and Contracting Officer. The Draft Transition Plan shall be submitted 180 calendar days prior to the expiration date of the contract, and the Final Transition Plan (approved by the COR and Contracting Officer) shall be submitted 60 calendar days prior to the expiration date of the contract.

3) Execute the Final Transition Plan and conduct an orderly, secure, and efficient transition of contract-related materials and activities to the successor contractor or to the Government.

Attachment 3 – Statement of Work Page 10 of 10

4) All import and export documents must be transferred to the subsequent Contractor and/or

DMID upon completion of this contract.

D. OPTIONS

In addition to the services/quantities outlined above to be provided for the base requirement, Options for additional services/quantities under the contract may be exercised at the discretion of the Government and are defined as follows:

A. Option Periods

The Government may extend the contract period of the performance in one-year increments beyond the contract base period. The total period of performance resulting from the base period plus all potential options is five years. If an option period is exercised, the services required will be within the same scope as those provided during the base year.

B. Option Quantities

The Government may exercise options for incremental increases in the level of effort. For each option quantity exercised, the Contractor shall provide an additional 11,180 labor hours. An option quantity may be exercised not more than twice within each contract year, as needed. If an option quantity is exercised, the services required will be within the same scope as those provided for the base level of effort requirement.

SEPTEMBER 2016

[END OF STATEMENT OF WORK]

Attachment 4

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND

OTHER STATEMENTS OF OFFERORS

Updated through FAC 2005-83

Last updated: 07/2015 This SECTION is made up of six parts as follows:

1. Annual Representations and Certifications, FAR 52.204-8

2. Commercial and Government Entity Code Reporting, FAR 52.204-16

3. Information Regarding Responsibility Matters, FAR 52.209-7

4. Cost Accounting Standards

5. Certification Regarding Environmental Tobacco Smoke

6. Certification of Institutional on Financial Conflicts of Interest

7. Disaster or Emergency Area Representation

8. Alternate – Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a

Felony Conviction Under Any Federal Law

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (DEC 2014), FAR Provision 52.204-8

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is [insert NAICS code].

(2) The Small Business Size Standard is [insert size standard].

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in System for Award Management (SAM), and Representations and Certifications section of SAM has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

(i) Paragraph (d) applies.

(ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation. [See Individual Representations and Certifications]

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

ATTACHMENT 4 - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENT OF OFFERORS

http://oamp.od.nih.gov/DGS/rc.html http://oamp.od.nih.gov/DGS/rc.html http://oamp.od.nih.gov/DGS/rc.html

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations— Representation.

(vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii)52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(viii) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(ix) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(x) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xi) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

ATTACHMENT 4 - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENT OF OFFERORS

(xii)52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv)52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA-designated items.

(xvi) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii) 52.225-4, Buy American--Free Trade Agreements—Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its

Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $79,507, the provision with its

Alternate II applies.

(D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its

Alternate III applies.

(xviii)52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-- Certification. This provision applies to all solicitations.

(xx) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following certifications are applicable as indicated by the Contracting Officer: [Contracting Officer check as appropriate.]

(i) 52.204-17, Ownership or Control of Offeror

(ii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

(iii) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification.

(iv) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

(v) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only).

(vi) 52.227-6, Royalty Information.

(A) Basic.

(B) Alternate I.

(vii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause No. Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision) https://www.acquisition.gov/

2. COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING, (JUL 2015) FAR Provision 52.204-16

Note to Offeror: This provision is incorporated by reference and is applicable when the resultant contract will contain FAR Provision 52.204-6 and/or FAR Provision 52.204-7.

3. INFORMATION REGARDING RESPONSIBILITY MATTERS, (JUL 2013) FAR Provision 52.209-7

Note to Offeror: This provision is applicable when the resultant contract is expected to exceed $500,000.

(a) Definitions. As used in this provision—

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options;

and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple- award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror has does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in—

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of

$100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database at www.acquisition.gov (see 52.204-7).

COST ACCOUNTING STANDARDS

4. Cost Accounting Standards Notices and Certification (May 2012), FAR Provision 52.230-1

Note: This notice does not apply to small businesses or foreign governments. This notice is in three parts, identified by Roman numerals I through III.

Offerors shall examine each part and provide the requested information in order to determine Cost Accounting Standards (CAS) requirements applicable to any resultant contract.

If the offeror is an educational institution, Part II does not apply unless the contemplated contract will be subject to full or modified CAS-coverage pursuant to 48 CFR 9903.201- 2(C)(5) or 9903.201-2(c)(6), respectively.

(a) Disclosure Statement -- Cost Accounting Practices and Certification

(2) Any contract in excess of $700,000 resulting from this solicitation will be subject to the requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts which are exempt as specified in 9903.201-1.

(3) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a part of the offeror's proposal under this solicitation unless the offeror has already submitted a Disclosure Statement disclosing the practices used in connection with the pricing of this proposal. If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the requirement for submission by providing the information requested in paragraph (c) of Part I of this http://www.acquisition.gov/ provision.

CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to practice for pricing proposals or accumulating and reporting contract performance cost data.

(4) Check the appropriate box below:

(i) Certificate of Concurrent Submission of Disclosure Statement.

The offeror hereby certifies that, as part of the offer, copies of the Disclosure Statement have been submitted as follows:

• original and one copy to the cognizant Administrative Contracting Officer (ACO), or cognizant Federal agency official authorized to act in that capacity (Federal official), as applicable, and;

• one copy to the cognizant Federal auditor.

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable.. Forms may be obtained from the cognizant ACO or Federal official and/or from the looseleaf version of the Federal Acquisition Regulation).

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the Disclosure Statement.

(ii) Certificate of Previously Submitted Disclosure Statement.

The offeror hereby certifies that the required Disclosure Statement was filed as follows:

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the applicable Disclosure Statement.

(iii) Certificate of Monetary Exemption.

The offeror hereby certifies that the offeror together with all divisions, subsidiaries, and affiliates under common control, did not receive net awards of negotiated prime contracts and subcontracts subject to CAS totaling more than $50 million or more in the cost accounting period immediately preceding the period in which this proposal was submitted.