CRN_AMN_RFP-15-100-SOL-00004.docx

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1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

RFP-15-100-SOL-00004

04/06/2015

6. REQUISITION/PURCHASE NO.

N/A

8. ADDRESS OFFER TO (If other than Item 7)

HHS/OS/ASPR/AMCG

330 Independence Ave, SW, RM G-640 Washington, DC 20201

NOTE: In sealed bid solicitations “offer” and “Offeror” mean “bid” and “bidder.”

SOLICITATION

(Hour) (Date) (Hour)

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 conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Elizabeth Steiner

a. TELEPHONE (NO COLLECT CALLS)

(202) 205-8926

b. E-MAIL ADDRESS Elizabeth.Steiner@hhs.gov

11. TABLE OF CONTENTS

((x)PAGE(S)

SEC.

SEC.

PAGE(S)

PAGE(S)

SEC.

SEC.

PAGE(S)

DESCRIPTION

(x)

DESCRIPTION

XK

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by Offeror)

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ___150___calendar days (60 calendar days unless a differentCALENDAR DAYS

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(Type or Print)

(Type or Print)

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

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

FAR (48 CFR) 53.214©

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/ Contract Form, accounting, appropriation and general information applicable to the contract award.

The contract schedule, set forth in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that will be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

PART I – THE SCHEDULE

Section B – Supplies or Service and Price / Cost

BARDA Chem and RadNuc Animal Model Development

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Request for Proposal (RFP) solicits proposals for an indefinite delivery, indefinite quantity (IDIQ) contract for the acquisition of Animal Model Development capabilities. It is anticipated that fixed-price and cost reimbursement type task orders will be issued to support the development of chemical, radiological, and nuclear (CRN) countermeasures.

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks appropriate Good Laboratory Practices (GLP) facilities that are adequate and available to establish new or existing animal tests and/or models for the development of CRN MCMs. In these models, the challenge dose should be the same as that which produces the human disease or condition and the pathophysiological mechanism of its toxicity should be reasonably well-understood and mimic the human disease/condition as closely as possible. When these models are used to test the efficacy of potential MCMs for CRN agents, the mechanism of action of the countermeasure will need to establish the utility of the animal model as a surrogate for humans.

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical Advanced Research and Development Authority (BARDA) to support development and acquisition of medical countermeasures (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures.

The development of animal models is a key element in the successful development of MCMs for chemical, radiological, and nuclear (CRN) threats, particularly since efficacy of products directed against most of these threats cannot be verified using clinical studies. In 2002, the FDA amended its regulations for drugs and biologics to permit approval or licensure of MCMs based on substantial evidence of effectiveness in animals when adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the “Animal Rule,” made the design and conduct of adequate efficacy studies in appropriate animal models of paramount regulatory importance, since the inference of efficacy in humans necessary for drug approval or licensure is based solely on efficacy data derived in animals. Demonstration of the safety of the medical countermeasure (drug or biologic) is done in normal, healthy adult humans and in some cases safety in a related pathology particularly if the drug or biologic is already approved for the related pathology.

B.2. SPECIFIC REQUIREMENTS

The requirements for the animal models to be developed under this solicitation are listed below:

· a reasonable well-understood pathophysiological mechanism of the toxicity of the substance (agent) and its prevention/reduction by the test product;

· the effect is demonstrated in one or more animal species expected to react with a response predictive of humans;

· an animal study outcome that is clearly related to the desired benefit in humans;

· data on pharmacokinetics/dynamics of the product in animals and humans that allows selection of effective doses in humans;

· allow for the testing and evaluation of candidate medical countermeasures;

· use optimized/validated assays to monitor response and bridge data to humans;

· conducted in accordance with preexisting requirements under the Good Laboratory Practices (GLP) (21 CFR 58) and adherence to Animal Welfare Act (7 U.S.C. 2131). GLP is expected for the definitive/pivotal animal studies but not necessary for the pilot studies.

B.3. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will contain a base period of one year (12 months) and four one year (12 months) option periods for a total maximum contract length of 5 years.

B.3.1. Base Period

Base Period of Performance: __________ through ___________.

Base Period Cost Reimbursement CLIN

TBD*

* Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete nonclinical study services

B.3.2. Option Periods

The final contract will contain Option CLINs agreed upon by the Government and the Offeror:

TBD*

TBD*

TBD*

TBD*

* Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete nonclinical study services

Unless the Government exercises its option pursuant to the option clause referenced in SECTION I, Contract Clauses, this contract consists only of the base period.

B.3.2.1. Option Year One The USG may exercise Option Year One (CLIN 0002) to extend the contract for animal model development from ________________ through _____________. .

B.3.2.2. Option Year Two The USG may exercise Option Year Two (CLIN 0003) to extend the contract for animal model development from ________________ through _____________. .

B.3.2.3. Option Year Three The USG may exercise Option Year Three (CLIN 0004) to extend the contract for animal model development from ________________ through _____________. .

B.3.2.3. Option Year Four The USG may exercise Option Year Four (CLIN 0005) to extend the contract for animal model development from ________________ through _____________. .

B.4. ADVANCE UNDERSTANDINGS

The final contract may contain additional advance understandings between the Government and the Offeror.

B.4.1. Minimum Ordering Amount

The Contractor(s) shall each be reimbursed by the Government a one-time amount not less than a total of $50,000 (regardless of option years exercised).The Government is not obligated to order more than the stated minimum for the entire contract period including option periods.

B.4.2. Maximum Ordering Amount – $100,000,000.00

The Contractor(s) shall not receive payment from the Government in an amount greater than $100,000,000.00 for successful performance under this contract. This contract ceiling is the Government’s most optimistic scenario with respect to the Government’s needs and level of funding.

B.4.3. Minimum Order Guarantee

The total minimum guarantee under this IDIQ contract is $50,000.00 (regardless of option years exercised). This one-time amount will be issued upon award on the base contract. If no Task Orders are received during the base contract, this amount can only be claimed at the end of the period of performance of the base contract if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one Task Order.

B.4.4. Pricing of Task Orders

The Government will issue Requests for Task Order Responses (RTORs) and contractors will compete for Task Orders for nonclinical research services based on the work described in SECTION C of this contract. Upon delivery and acceptance of the services described in each Task Order, the Government shall pay to the Contractor the price, costs or fee set forth in the Task Order.

Individual Task Orders will be issued as requirements occur, and will specify work to be performed. The Contractor shall perform all services in accordance with each task order’s work statement/specifications. The terms and conditions under the base IDIQ contract are incorporated into all task orders issued pursuant to this contract.

See SECTION G.4. for further ordering information and procedures.

B.4.5. Funding

Funds consisting of the total value of the minimum guarantee will be obligated on the base contract. Funds for the services provided will be obligated, at the task order level, as they become available, unilaterally by the Government.

B.4.6. Cost Unallowable Unless Authorized by the Contracting Officer

This section prohibits or restricts the use of contract funds for the following, unless otherwise approved in advance by the Contracting Officer:

a) Acquisition, by purchase or lease, of any interest in real property;

b) Rearrangement or alteration of facilities;

c) Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value;

d) Accountable Government Property;

e) Overtime

f) Travel to attend general scientific meetings/conferences;

g) Foreign Travel Costs;

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

i) Costs to be paid for the performance of a fixed-price subcontract that exceeds $150,000.00;

j) Refreshments and Meal Expenditures.

B.4.7. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

For contract work performed on a cost reimbursement basis, the Contractor agrees to provide a detailed breakdown on invoices of the below cost categories as applicable. A sample invoice form is provided as Attachment #7.

1. Direct Labor - Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.

2. Fringe Benefits - Cite rate and amount

3. Overhead - Cite rate and amount

4. Materials & Supplies - Include detailed breakdown when unit price is over $1,000.

5. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

6. Consultant Fees - Identify individuals and amounts.

7. Subcontracts - Attach subcontractor invoice(s).

8. Equipment - Cite authorization and amount.

9. G&A - Cite rate and amount.

10. Total Cost

11. Fixed Fee

12. Total Cost Plus Fixed Fee (Total CPFF)

For contract work performed on a cost reimbursement basis, monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government. Also note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31. Invoice submission information is provided in SECTION G.6.

Section C – Statement of Objectives (SOO)

C.1. INTRODUCTION/BACKROUND

Within the Federal government, the Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures for the adverse health effects resulting from intentional exposure to CBRN threat agents, pandemics and emerging infectious disease threats. Response and recovery were identified as key elements of national defense in the National Strategy to Combat Weapons of Mass Destruction (http://www.whitehouse.gov/new/releases/2002/12/WMDStrategy.pdf). The lead role of HHS in these endeavors was emphasized in Biodefense for the 21st Century (http://www.whitehouse.gov/homeland/20040430.html) and in the National Strategy for Medical Countermeasures against Weapons of Mass Destruction (http://www.whitehouse.gov/news/releases/2007/02/20070207-2.html). These three documents represent the foundation for addressing the nation’s CBRN medical countermeasure needs.

HHS, through the interagency Public Health Emergency and Medical Countermeasure Enterprise (PHEMCE) is responsible for the integration of requirements for the advanced development and procurement of medical countermeasures for CBRN threats specified by DHS as material threats. The HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy), published in the Federal Register on March 20, 2007 describes the strategic policy goals and objectives for identifying requirements and establishes the priorities for the development of the medical countermeasures. The HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Implementation Plan), published in the Federal Register on April 2007 and updated December 2012, delineates HHS medical countermeasure priorities for research, development and acquisition to address the highest priority CBRN threats.

The definition of animal models is a key element in the development of medical countermeasures for CBRN threats, particularly since efficacy of products against most of these threats cannot be verified using clinical studies. In 2002, the FDA amended its regulations for drugs and biologics to permit approval or licensure of medical countermeasures based on substantial evidence of effectiveness in animals when adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances, and relevant field efficacy trials in humans are not feasible. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the “Animal Rule,” made the design and conduct of adequate efficacy studies in appropriate animal models of paramount regulatory importance, since the inference of efficacy in humans is based on efficacy data derived in animals. The primary demonstration of safety of the medical countermeasure (drug or biologic) is conducted in human clinical studies, although non-clinical data will be used to evaluate safety.

C.2. General Objectives

C.2.1. The United States Government (USG) seeks appropriate Good Laboratory Practices (GLP) facilities that are adequate and available to develop new or existing animal tests and/or models for the development of CRN MCMs to include applicable supporting bioanalytical assays. In these models, the challenge dose generally should be the same as that which produces the human disease or condition and the pathophysiological mechanism of its toxicity should be reasonably well-understood and mimic the human disease/condition as closely as possible. When these models are used to test the efficacy of potential MCMs for CRN agents, the mechanism of action of the countermeasure will be needed to correlate and defend the use of the animal model as a surrogate for humans. Although not every study conducted under this contract will be GLP, Offerors should have previous experience conducting GLP studies in small and large animal models at their facilities.

C.2.2 The USG seeks facilities that have ready access to chemical threat agents through a Bailment Agreement with Edgewood Chemical and Biological Center (ECBC) or equivalent, a Medical Chemical Research, Development and Testing Contract with US Army Medical Research Institute of Chemical Defense (USAMRICD), or qualified laboratories with the requisite experience, facilities, capabilities and personnel to handle chemical threat agents under all applicable laws.

C.2.3. The USG seeks laboratories that have established protocols for routine care and health surveillance for laboratory animals, including on-call veterinary coverage 24 hours per day.

C.2.4. The USG seeks laboratories that can conduct studies to establish the pathophysiology/natural history of CRN threat agents in appropriate animal species.

C.2.5. The USG seeks laboratories that can design a protocol and perform efficacy evaluations in various species on candidate compounds (e.g., drugs and biologics) as specified in the Sample Task Order Statement of Work (Attachment #1 and #2) to permit further product development including, but not limited to, the assessment and optimization of the formulation, route of administration, effective dose level, dose schedule, therapeutic index (i.e. the ratio of the drug/biologic’s adverse event plasma concentration over the plasma concentration sufficient for efficacy), and timing of administration (pre-exposure, post-exposure, delayed administration).

C.2.6. The USG seeks laboratories that can provide analytical support to monitor the progression of disease in animal models and demonstrate prospective endpoints for efficacy evaluation.

C.2.7. The USG seeks laboratories that have adequate statistical and pharmacokinetics support to analyze and predict experimental hypotheses for models, including pharmacokinetic modeling (both individual animal and population approaches using compartmental and non-compartmental methods).

C.2.8. The USG seeks laboratories with the capability of controlled exposure of various animal species to chemical threat agents in order to develop models to evaluate the efficacy of potential countermeasures to nerve agents, vesicants, cyanide, pulmonary agents, and toxic industrial chemicals (TICs) by inhalation, ingestion and percutaneous routes.

C.2.9. The USG seeks laboratories with the capability to perform short to long term (10-180+days) non-GLP and GLP animal studies employing acute radiation exposures from Sr90, Cs-137, Co-60, LINAC, X-ray, or other accepted exposure instrumentation. Well controlled, partial-body and total-body ionizing radiation exposures are required for the lethal range for the selected species, within the constraint of acceptable dose rates within 50 – 100 cGy/min or more, with uniform field flux and field sizes for both small and large animals (e.g. rodents, NHPs, minipigs). Beta sources and low penetrating x-ray exposure are required for skin injury and burn assessment studies with working knowledge of skin-injury measurements and scoring systems. The institution shall have proper assessment tools and procedures, including phantoms, for accurate determination of dosimetry. In addition, the institution shall have reasonable animal throughput and holding capacity to engage all animal irradiations in a single study (i.e., n=~20-100,) within 2-4 months. The site shall have an independent Quality Assurance Unit (QAU) to provide oversight of GLP studies as outlined in 21 CFR 58.35. Institutional lethality probit curves already conducted for selected species are a plus.

C.2.10. The USG seeks laboratories with nimble and flexible capability to prioritize and conduct nonclinical studies in support of countermeasure development in response to any attack or threat, whether known or unknown, novel or reemerging, natural or intentional.

C.2.11. In all cases described above, the USG seeks laboratories with the capability to perform these procedures and studies in animal models of human at-risk and special populations (e.g., pediatric, geriatric, pregnancy, etc).

C.3. Program, Personnel and Risk Management:

C.3.1.The USG seeks laboratories that can provide and implement plans for the overall management, integration and coordination of all contract activities, timelines, and task-linked budgets including the management and coordination of activities carried out under subcontracts. The Offeror(s) shall develop a risk mitigation plan highlighting potential problems and/or issues that may arise during each task order, their impact on cost, performance and timelines, and appropriate remediation plans.

C.3.2. The USG seeks laboratories that can develop a quality control (QC)/quality assurance (QA) monitoring plan that shall ensure appropriate storage conditions of the CRN agent(s) to be tested as well as the appropriate storage conditions and documentation regarding the handling and security for the candidate products (drugs/biologics) being tested for efficacy. The QC/QA program and staff shall also demonstrate responsibility for care and use of animals as defined in C.1.

C.3.3. The USG seeks laboratories or organizations that can provide and maintain a database management system using a software application approved by the COR/CO. The database must support all data types, protocols, and experimental results generated by, or related to, the requirements of the contract. The database shall provide the capability to conduct queries and analyses, export data and in a variety of formats, disseminate data, and submit experimental data to the COR/CO. The database should include an electronic inventory of all products (bioassay reagents, drug/biologic inventories, etc), pathogens, chemical agents, radionuclides, specimens, materials, and reagents received, produced, stored, and shipped that has compound identifiers, amounts available, storage locations, shipping data and other biological and chemical characteristics of the compound(s).

C.3.4. The Offerors shall define confidential data/information and how it will be extracted in a format compatible with programs for publication in technical journals and/or shared in government determined systems.

C.3.5. The USG seeks laboratories that can submit evidence of an effective Regulatory and Quality Management System (QMS) (21 CFR Part 58). Offeror(s) shall ensure that the details in the submitted proposal incorporate: 1) QMS in all aspects of the proposal to fulfill the proposal objectives; 2) a copy of a Quality Plan; 3) a quality reporting structure; 4) an FDA inspection history that provides all observations listed on the FDA Form-483 and associated corrective actions; 5) a regulatory platform that can comply with the evolving regulatory environment regarding requirements for animal research and the FDA regulatory guideline for animal studies in support of approval/ or licensure, such as, 21 CFR Part 58, “Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies,” and 21 CFR Parts 314 and 601 and subparts, “New Drug and Biological Drug Products: Evidence Needed to Demonstrate Effectiveness of medical countermeasures under New Drugs when Human Efficacy Studies Are Not Ethical or Feasible. (i.e., the Animal Rule).

C.3.6. The Offeror(s) shall propose an integrated management plan for the animal model development program including key subcontractors. Management of personnel should include, but is not limited to, providing a list of key individuals and their qualifications to carry out the work detailed in the SOO.

Section D – Packaging, Marking and Shipping

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

Section E – Inspection and Acceptance

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative. Technical inspection and acceptance will be take place at:

Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response 330 Independence Avenue, S.W.

Room G640 Washington, D.C. 20201

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.243-2, Changes – Cost Reimbursement (August 1987)

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

Section F – deliveries or Performance

F.1. PERIOD OF PERFORMANCE

The base period of performance under this contract shall be for twelve (12) months from date of award. The period of performance may be extended with the exercise of option(s), structured as CLINs, as set forth in SECTION B.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this contract and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or their duly authorized representative.

Deliverables will be further defined upon the issuance of specific Task Orders.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents will be delivered electronically (via email to the Contracting Officer) and in original hard copy to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR). Unless otherwise specified by the Contracting Officer all hard copy deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

Contracting Officer

HHS/ASPR/AMCG

200 C St. SW Washington, DC 20024 Email: TBD Contracting Officer

HHS/ASPR/AMCG

330 Independence Ave. SW, Room G640

Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW Washington, DC 20024 Email: TBD Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Ave. SW, Room G640

In addition to those reports required by other terms of this contract, the Contractor(s) shall submit to the CO and the COR technical progress reports as identified in the TO. These reports shall be subject to the technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the formats described in the following section.

F.3.2 Description and Format of Reports

1. Monthly Technical Progress Reports

During periods in which work is being performed under a TO, Monthly Technical Progress Reports are due on the fifteenth (15th) calendar day of each month for the previous calendar month. The Contractor shall submit a report to the COR and the CO. The Contractor shall submit a separate Monthly Technical Progress Report for each TO under which work is being performed. Monthly Technical Progress Reports are not required for periods with no active Task Orders.

The format and type of Monthly Technical Progress Report and Executive Summary will be provided by the COR within fifteen (15) calendar days of contract award. Monthly Technical Progress Reports will include project timelines, milestones and summaries. A Monthly Technical Progress Report will not be required for the period when a Quarterly Technical Report or Final Technical Report is due. The Contractor shall submit one copy of the Monthly Technical Progress Report electronically via e-mail to the COR and the CO.

The report shall be submitted in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project or compatible, editable formats. Technical Progress reports shall, at a minimum, include the following information:

Title Page: The Technical Progress Report title page shall include the contract number and title, the period of performance or milestone being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Distribution List: A list of persons receiving the Technical Progress report.

Introduction/ Background: An introduction covering the purpose and scope of the report.

Summary: A table organized by Task Order summarizing ongoing activities

Progress: The report shall detail, document and summarize, organized by Task Order, the results of work performed, test results and milestones achieved during the period covered. Progress should be represented as % of total project plan completed, as well as % completed for the month based on forecasted for the month. Information supporting the summary shall also be provided.

A summary of work planned for the next reporting period shall be included.

Issues: Issues resolved, new issues and outstanding issues shall be enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned. Revised timelines shall be provided.

Invoices: Summary of any invoices submitted during the reporting period.

Action Items: Summary table of activities or tasks to be accomplished by a certain date and by whom.

Attachments: Each report will include an attachment with an up to date contract history including invoice submission/acceptance dates, and modifications. Results on the project are provided as attachments where appropriate.

1. Quarterly Technical Progress Reports

The format and type of the Quarterly Technical Progress Report and Executive Summary will be provided by the COR within fifteen (15) calendar days of contract award. Quarterly Technical Progress Reports will include project summaries as well as performance metrics for the prime contractor. A Quarterly Technical Progress Report will not be required for the period when the Final Technical Report is due. The Contractor shall submit one copy of the Quarterly Technical Progress Report electronically via e-mail to the COR and CO. The report shall be submitted in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project or compatible, editable formats.

Quarterly Technical Progress Reports are required for periods with no active Task Orders.

Quarterly Technical Progress reports shall, at a minimum, include the following information:

Title Page: The Quarterly Technical Progress Report title page shall include the contract number and title, the period of performance being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Distribution List: A list of persons receiving the Technical Progress report.

Introduction/ Background: An introduction covering the purpose and scope of the report.

Summary: A table organized by Task Order summarizing ongoing activities.

Progress: The report shall summarize, organized by Task Order, the results of work performed. Progress should be represented as % of total project plan completed, as well as % completed for the quarter based on forecasted for the quarter. Information supporting the summary shall also be provided. A summary of work and travel planned for the next reporting period shall also be provided.

Issues: Issues resolved, new issues and outstanding issues shall be enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned. Revised timelines shall be provided.

Invoices: Summary of any invoices submitted during the reporting period.

Action Items: Summary table of activities or tasks to be accomplished by a certain date and by whom.

Attachments: Each report will include an attachment with an up to date contract history including invoice submission/acceptance dates, and modifications. Results on the project are provided as attachments where appropriate.

Executive Summary

The Executive Summary shall accompany each Technical Progress Report, be formatted as a Microsoft PowerPoint presentation, and include the following:

Title page: Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor's name and the date of submission.

Project Progress: Presented as milestone events, test results, tasks and other activities achieved during the reporting period as talking point bullets.

Project Issues: Presented headings and each item as a talking point bullet.

Final Technical Report

For each TO, a Final Technical closeout report will be compiled. The Final Technical Closeout Report will include the following:

Title page: containing Executive Title, the contract number and title, TO Title and period of performance reported, the contractor's name and the date of submission.

Project Progress: presented as milestone target and accomplishment, test results, tasks and other activities achieved during the reporting period as talking point bullets.

Project Issues and Resolutions: presented headings and each item as a talking point bullet.

Final Closeout Report

The Contractor shall submit a comprehensive Final Report that details, documents, and summarizes the results of the entire (base and all option periods) contract work. The report shall explain comprehensively the results achieved. It shall also contain a summary of all Task Orders issued under the contract and a determination that everything under the contract has been completed and accepted. A draft Final Report shall be submitted to the CO and COR for review and comment at least 45 days prior to contract expiration date. Upon final acceptance by the CO, an electronic copy shall be submitted to the CO not later than 30 days following the expiration date of the contract.

F.4. DELIVERABLE SCHEDULE

1.0 Kickoff Meeting/Status Update Meetings/Annual Meeting/Periodic Site Visits/Security and Quality Systems Audits The contractor shall complete a Kickoff meeting after contract award and/or within a month of task/delivery order award to be held at a location determined by the COR. The purpose of the Task/Delivery Order initiation meeting will be to orient the contractor to HHS/BARDA task/delivery order procedures, review contract requirements, and to plan implementation of initial task/delivery order activities.

Status Update Meetings: Plan and conduct meetings of the contractor’s Program Director, Program Team, Contracting Officer’s Representative and Contracting Officer. This will include other BARDA personnel deemed appropriate by the Contracting Officer’s Representative, at a minimum of monthly intervals, either in person or via teleconference, to review protocols, the status of approved work assignments, discuss any matters relevant to the scientific and financial administration of the contract and future activities. The contractor shall prepare and distribute the agenda as well as meeting/teleconference materials to all participants, provide a summary of all meetings, and teleconferences.

Annual Meetings: The contractor shall arrange and may conduct annual site visits for AMCG contract and BARDA program staffs to review and discuss the following items: project progress; problems, obstacles, and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans. These site visits shall be attended by the Principal Investigator, the contractor’s business representative, and all key personnel. The contractor shall be responsible for the following activities:

1.Planning and submitting the agenda to the Contracting Officer’s Representative for approval 2.Developing written and oral presentation materials of all task/delivery orders 3.Presenting summaries of all active task/delivery orders 4.Discussing timelines related to active and future task/delivery orders 5.Discuss methodologies and approaches Periodic Site Visits will include, if applicable, subcontractor facilities.

Security and Quality Systems Audits/QA audits The contractor shall take the necessary corrective action within a timely manner.

Within a month of contract award a Kickoff meeting will be held. Program Review Meetings shall occur at least annually during contract period of performance.

The schedule for Status Update Meetings meetings will be established by the Contracting Officer’s Representative and Contracting Officer after contract award.

Annual Meetings should occur once a year within 30 days of the anniversary of the contract award date.

Periodic Site Visits will occur on an adhoc basis.

Security and Quality Systems Audits/QA audits may be conducted pre-award and on an ad hoc basis. A summary of these audits will be provided within 25 business days to the contractor.

2.0 Biweekly Teleconference

3.0 Monthly/Quarterly/Annual, Task Order/Milestone Technical Progress Reports (Described in F.3.2) The Monthly/Quarterly/Annual Task/Order Technical Progress reports shall address each of the below items and be cross-referenced to the WBS in the Gantt chart.

1. An Executive Summary in MS PowerPoint format, highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory. The Executive Summary should be limited to a few slides, and also highlight only critical issues for that reporting period and resolution approach.

2. Progress in meeting contract milestones - broken out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions. The reports shall detail the planned progress and actual progress during the period covered, explaining occurrences of any differences between the two, and the corrective steps and actions are planned, if behind schedule.

3. The reports shall also include a three month rolling forecast of key planned activities, referencing the WBS.

4. A tracking log of progress on regulatory submissions with the FDA submission number, description of submission, date of submission, status of submission, and next steps.

5. Estimated and Actual Expenses This report shall also contain a narrative statement as to whether there is any discrepancy at this time between the % of work completed and the cumulative costs incurred to date. This section of the report shall also contain estimates for the subcontractors' expenses from the previous month if the subcontractor did not submit a bill in the previous month. These expenses shall be listed for each subcontractor.

If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.

Milestones will be identified for each Task/Delivery Order and progress toward each Milestone will be reported as part of the Technical Progress Report. Separate Milestone reporting is not required.

Reports shall be submitted in an electronic format on the 15th day of each month for the previous calendar month with an Annual Report submitted on the 15th day of the final month of each contract year for the previous twelve calendar months. These reports are subject to the technical inspection and requests for clarification by the Contracting Officer’s Representative. Progress reports are not required for the periods when the Annual Report(s) and Final Report are due.

4.0 Invention Reporting Requirement All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Contracting Officer.

If no invention is disclosed, or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer.

In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

5.0 Technical Documents The contractor shall provide complete technical documents for COR review and approval. All documents shall be duly marked as either 'Draft' or 'Final'. These technical documents shall include, but shall not be limited to, the following:

.1. Non-clinical study overview with flowchart (demonstration of relationship between studies should include clinical study)

2. Draft SOWs to be sent to subcontractors for concept approval, including number of animals

3. Draft protocols and critical reagents

4. Draft and Final Reports

Draft documents shall be submitted to COR for review and comment. COR will provide feedback within 10 business days. Contractor shall submit all final technical documents within 10 business days of completion or as mutually agreed to during the program execution with the Contracting Officer’s Representative

6.0 Draft Final Contract Report

6.1 Final Contract Report

7.0 Standard Operating Procedures

8.0 FDA Correspondence and Mtgs Summaries

8.1 FDA Meetings

8.2 FDA Submissions

Final FDA submissions shall be submitted to COR concurrently or no later than 1 calendar day of its submission to CBER/CDER.

8.3 FDA Audits