RFP-Animal Models v12 17Sep2010 Final.pdf

PAGESPAGES

SOLICITATION, OFFER AND

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 102

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date)(Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

(Date)(Hour)

SEC. PAGE(S) SEC. PAGE(S)

CALENDAR DAYS

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

BARDA 10-100-SOL-00025

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

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

DHHS/ASPR/AMCG

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

See Item 7

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

SOLICITATION

9. Sealed offers in original and 1 copy for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in see item 7 until 4:30pm local time 11/22/2010

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

Jeannett W. Jackman

B.

(202) 420-0829

TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

Jeannett.Jackman@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 43

X B SUPPLIES OR SERVICES AND PRICES/COSTS 3 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 9 X J LIST OF ATTACHMENTS 48

X D PACKAGING AND MARKING 12 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 13 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 14 X K OTHER STATEMENTS OF OFFERORS 49

X G CONTRACT ADMINISTRATION DATA 21 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 50

X H SPECIAL CONTRACT REQUIREMENTS 30 X M EVALUATION FACTORS FOR AWARD 61

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 180 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

K

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

15A. NAME (Type or Print)

AND

ADDRESS

OF

OFFEROR

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

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

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

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

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.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

TABLE OF CONTENTS

PART I – THE SCHEDULE Page #

Section A –Solicitation Form

Section B – Supplies or Services and Price/Costs

Section C – Statement of Objectives

Section D – Packaging and Marking

Section E – Inspection and Acceptance

Section F – Deliveries or Performance

Section G – Contract Administration

Section H – Special Contract Requirements

PART II – CONTRACT CLAUSES

Section I – Contract Clauses

PART III – ATTACHMENTS

Section J – List of Documents, Exhibits, and Other Attachments

PART IV – REPRESENTATIONS AND INSTRUCTIONS

Section K – Representations, Certifications and Other Statements of Offerors

Section L – Instructions, Conditions, and Notices to Offerors

Section M – Evaluation Factors for Award

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN

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, HEREIN, 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 PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND

WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE

IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO

UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B – SUPPLIES OR SERVICE AND PRICE/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for the development of animal models. It is anticipated that cost reimbursement task orders will be issued under this contract. The development of animal models is a key element in the successful development of medical countermeasures for threat agents, particularly since efficacy of products against most of these threats could never be verified using clinical studies.

Through this Request for Proposal (RFP), the Biomedical Advanced Research and Development Authority (BARDA) encourages the development of animal models to meet the threats of CBRN agents, influenza, and emerging infectious diseases in support of the preparedness mission and priorities of the Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), as articulated in the PHEMCE Implementation Plan for CBRN Threats (http://www.hhs.gov/aspr/barda/phemce/index.html) and the HHS Pandemic Influenza Plan (http://www.hhs.gov/pandemicflu/plan).

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. 2. PRICE/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.

A. BASE CONTRACT

The offeror shall provide all labor categories and labor rates for work under the prospective contract. The hourly rates proposed for each labor category shall be fully burdened rates, including any indirect or overhead rates applicable. The fully burdened hourly rates will be incorporated into any resultant contract awards under B.3. Advance Understandings, and must be used for budgeting task orders and reimbursement of labor costs.

(1) BASE PERIODCOST REIMBURSEMENT CLIN

ITEM SUPPLIES/SERVICES Estimated Cost Fee Cost Plus

Fixed Fee 0001 Animal Model Development and Technical Reports on task orders

B. CONTRACT OPTIONS COST REIMBURSEMENT CLINs

ITEM SUPPLIES/SERVICES Estimated Cost Fee Cost Plus Fixed Fee

0002 Option Year One - Animal Model Development and Technical Reports on task orders

0003 Option Year Two - Animal Model Development and

0004 Option Year Three - Animal Model Development and

0005 Option Year Four - Animal Model Development and

B.3. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

In addition, the following advance understandings are applicable to this solicitation:

a. MINIMUM AND MAXIMUM ORDERING ESTIMATES

1. MINIMUM ORDERING AMOUNT: The Government currently has a Minimum, One-Time, Ordering Amount of $50,000 for all contract Task Orders awarded under this solicitation (BARDA 10-100-

SOL-00025). The Government is not obligated to order more than the stated minimum for the entire contract period including option periods.

2. MAXIMUM ORDERING ESTIMATE: The Government currently has an Estimated Maximum Ordering Estimate of $7,500,000 for all contract Task Orders awarded under this solicitation (BARDA 10- 100-SOL-00025). This contract ceiling is the Government’s most optimistic scenario with respect to monetary appropriations, future requirements. This is an estimate. Therefore, it allows for potential growth for increased requirements.

b. Pricing of Task Orders

Individual Task Orders will be issued as requirements occur. Task Orders will specify work to be performed and will reflect the labor rates of the proposed staff in effect when the task order is issued (in accordance with the Advanced Understanding to be included in the contract awards). The Contractor shall perform all services in accordance with each task order’s work statement/specifications. The terms and conditions set forth in the contracts will always apply. All Task Orders will be cost reimbursement.

c. Pricing Table

(a) Offeror shall provide prices for the total estimated support for the task order, including pricing information with labor categories consistent with proposed qualifications for personnel supporting the requirement, fully burdened labor rates, and proposed hours for the full period of performance.

(b) Pricing is to be provided, in the table below, as follows for the ordering period:

PRICE/ORDERING TABLE

Labor Category Estimated Hours Standard Hourly Rate

Total Price

Labor Subtotal

Estimated Other Direct Costs

Estimated Grand Total

d. Provisions Applicable To Direct Costs

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

e. Fulfilling Minimum Ordering Requirements

The Government has no obligation to issue Task Orders to any Contractor beyond the minimum amount specified above. For each successful contractor there will be a one time “minimum guarantee award amount” during the life of the contract which includes all option years, if exercised. This amount can only be claimed at the end of the contract period if the contractor takes advantage of fair opportunity, as described in FAR 16.505, by proposing on at least one Task Order per year.

f. Funding

Funds for the services provided will be obligated, at the task order level, as they become available, or excess funds de-obligated at the task order level, by modification to the task order contracts unilaterally by the Government. The contractor will only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed if the Contractor meets the requirements as stated in B.6.

g. Person in Plant (Facility)

With 7 days advance notice to the contractor, the government may place a man in plant in the contractor’s and/or subcontractor’s facility. The person in plant is restricted to observing, verifying, and surveying the contractor’s performance under this contract.

h. Data Rights/Publication: Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted for BARDA Contracting Officer Technical Representative (“COTR”) review no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication. Contract support shall be acknowledged in all such publications. A “publication” is defined as an issue of printed material offered for distribution or any communication or oral presentation of information. The BARDA COTR will review all manuscripts and abstracts in a period of time not to exceed thirty (30) calendar days for manuscripts and fifteen (15) days for abstracts from receipt and will either agree to the publication/disclosure or recommend changes.

i. Offerors shall provide all draft documents to BARDA for review and comment within 10 days of completion of study report. BARDA will provide feedback within 5 business days. Contractor shall submit all final technical documents within 5 calendar days of completion or as mutually agreed to during the program execution with the COTR.

j. Study Design Review Meetings

For each non-clinical study, the Contractor shall distribute draft study plans and protocols for USG review prior to the conduct of a Study Design Review Meeting between the USG and the contractor as part of the pre-approval process as described in paragraph B.3.(c).

The Contractor shall facilitate a pre-design meeting with the Contractor, Sub-contractor performing the study and the USG for all non-clinical studies. Review meetings will be held at major Milestones at the request of the USG, to enhance communications between the USG and the Contractor.

k. Access to Documentation and Interaction with Regulatory Agencies

The USG shall have physical and electronic access, as requested, to all documentation and data generated during this contract, including but not limited to, all Contractor efforts, all Subcontractor efforts, communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, and all Contractor’s commitments and responses. Contractor shall provide the government with an electronic copy of all written or verbal correspondence with the FDA, or foreign equivalent within 24 hours of the event. The contractor shall notify the USG of all unannounced site visits/audits by regulatory agencies within 24 hours of said agency’s arrival. The contractor shall provide the USG with a non-redacted copy of any FDA Form-482, Form FDA-483, and Establishment Inspection Report (EIR) within 24 hours of receipt. The contractor shall include the USG in all scheduled meetings and teleconferences with regulatory agencies.

Prior to implementation, the contractor shall allow the USG to review and provide comments on all quality agreements and master contracts with sub-contractors. The Contractor shall provide copies of site visits and audit reports of subcontractors to the USG within 25 business days of the visit/audit.

l. Security Plan – Reserved The Contractor agrees to provide data generated from this contract to the Contracting Officer upon request either in the form of an email attachment or via delivery to a secured Government eRoom (shared government internet portal).

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

The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories (as applicable):

1. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, 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 CPFF

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

n. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

o. Equipment

All Equipment purchases in excess of $1,000.00 must receive prior written consent of the Contracting Officer. Upon review of quotes and supporting documentation the Contracting Officer may provide written consent for the equipment purchases.

p. Site Visits and Inspections

At the discretion of the USG and independent of activities conducted by the Contractor, with ten (10) business days notice to the contractor, the USG reserves the right to conduct site visits and inspections on an as needed basis, including collection of product samples and intermediates held by the Contractor, or Subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall coordinate the visit through the Prime Contractor. Under time-sensitive or critical situations, the USG reserves the right to suspend the 10 day notice to the Contractor. The areas included under the site visit could include, but are not limited to: security, regulatory and quality systems, and cGMP/GLP/GCP compliance.

SECTION C - STATEMENT OF OBJECTIVES (SOO)

Independently and not as an agent of the USG, the Offeror(s) shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the USG, as needed to perform the Statement of Objectives, attached hereto and made a part of this Solicitation.

Offeror(s) may propose in response to Chemical, Biological, Radiological, or Nuclear areas of the SOO as defined in Section C.1. Technical Capabilities; Offerors may choose to respond to one or more areas of their choosing and are not expected to respond to the SOO in its entirety.

HHS/BARDA 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 Objectives and, consequently, that the Offeror(s) may need to be supported to a certain extent by the expertise and resources of subcontractors to perform some of the activities required. However, the Offeror(s) shall be responsible for all work performed under this contract including that performed by a subcontractor(s).

C.1 Technical Capabilities

C.1.1. 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 CBRN, pandemic, and emerging disease MCMs. 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 CBRN, pandemic, and emerging disease agents, the mechanism of action of the countermeasure will need to establish the utility of the animal model as a surrogate for humans.

C.1.2. The USG seeks safe facilities that have current approved Federal, State and/or local licenses/certifications for animal work and where applicable, ensure that the select agent regulations through CDC and/or USDA are followed (42 CFR Part 73, 7 CFR Part 331, and/or 9 CFR Part 121).

The USG seeks to conduct work in accordance with all applicable Federal, state and local laws, codes, ordinances and regulations (or if foreign, equivalent regulatory oversight).

C.1.3. 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.1.4. The USG seeks laboratories that can conduct pilot efficacy studies for candidate MCMs using new or existing animal models or tests (see C.1.1.) to establish the pathophysiology/natural history of threat agents in appropriate animal species.

C.1.5. The USG seeks laboratories that can perform efficacy evaluations in various species on candidate compounds (e.g., drugs and biologics) as specified in the Task Order Statement of Work, 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.1.6. The USG seeks laboratories that can provide microbiological support for the pathogens(s) specified in the Task Order Statement of Work, including quality-controlled master and working banks; SOPs for production and characterization of challenge material under standardized media and growth conditions, and master and working banks for cell lines where applicable. The USG seeks laboratories that can develop and/or provide acceptance criteria for the use of challenge material in animal model studies.

C.1.7. The USG seeks laboratories that can provide analytical support to monitor the progression of disease in animal models and demonstrate prospective correlates of protection (e.g., clinical laboratory capabilities and adoption of novel biomarker testing).

C.1.8. 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.1.9. 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 topical routes.

C.1.10. The USG seeks laboratories with the capability to perform radiation exposure studies using Cs-137, Co-60, LINAC, X-ray or other accepted instrumentation for controlled exposures of animals to lethal-ionizing radiation within the constraint of acceptable dose rates (predominant need is ionizing radiation dose rates within 50 – 400 cGy/min), with uniform field flux and field sizes for large and small animals (e.g. minipigs ~90 kg and mice ~25 gm).

C.1.11. 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.2. Program, Personnel and Risk Management

C.2.1. 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.2.2. The USG seeks laboratories that can develop a quality control (QC)/quality assurance (QA) monitoring plan that shall ensure appropriate storage conditions of the select/test CBRN, pandemic, and emerging disease 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 described in C.1.

C.2.3. The USG seeks laboratories or organizations that can provide and maintain a database management system using a software application approved by the Contracting Officer Technical Representative/Contracting Officer (COTR/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 COTR/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.2.4. 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.2.5. Successful Offerors must provide a laboratory 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.2.6. 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.

C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor/FAR Clause 52.227-13, Patent Rights-Ownership by the Government] including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892- 7980 (Telephone: 301-435-1986). 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.

Contracting Officer

DHHS/ASPR/AMCG

Attn.: Contracting Officer 330 Independence Ave., S.W.

Room G644 Washington, D.C. 20201

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 at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA.

SECTION D – PACKAGING AND MARKING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, delivery of the items or reports to be furnished to the government under this contract (including invoices) shall be made by first class mail, overnight carrier, or e-mail.

Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G644 Washington, DC 20201 Email:

Contracting Officer Technical Representative

HHS/ASPR/BARDA

330 Independence Avenue, S.W.

Room G644 Washington, DC 20201 Email:

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE (JULY 1999)

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the designated Contracting Officer’s Technical Representative is the authorized representative of the Contracting Officer.

c. Technical inspection and acceptance will be performed at:

Biomedical Advanced Research and Development Authority

Office of the Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

330 Independence Avenue, S.W., Room G644

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause(s) 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. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov/comp/far/index.html

FAR Source Title and Date

FAR Clause 52.243-2 Changes – Cost Reimbursement (Aug 1987)

FAR Clause 52.246-1 Contractor Inspection Requirements (Apr 1984)

FAR Clause 52.246-5 Inspection of Research and Development – Cost Reimbursement (May 2001)

SECTION F - DELIVERIES OR PERFORMANCE

F.1. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. Upon issuance of task order, deliverables will be defined.

b. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Item Deliverable Description Addresses Delivery Schedule

Technical Task Order Progress Reports

1)

Kickoff Meeting/Status Update Meetings

The contractor shall complete a Kickoff meeting after task order award and shall hold recurring Program Review Meetings.

CO: (1) electronic copy

COTR: One (1) electronic

Within a month of task order issuance, but after submission of a draft IPDP, for Kick Off meeting (Final IPDP revision to be submitted per Deliverable #10). Program Review Meetings shall occur at least annually during task order period of performance.

2) Biweekly Teleconference The Contractor shall participate in biweekly teleconferences with BARDA to discuss the performance of the task order under the contract. The Contractor shall record, maintain and provide draft meeting minutes to the Contracting Officer Technical Representative (“COTR”)for approval within three days after teleconference.

The COTR will approve the draft version. The Contractor shall distribute the final approved version duly marked as final within 3 business days after receipt of BARDA approval.

Same as CO and COTR above

Biweekly or as negotiated by all parties

3) Monthly Task Order Technical Progress Report

2 electronic Same as CO and COTR above

The 15th calendar day of each month following the first full month of the task order. The Monthly Progress Report will not be required on months when an Annual or Quarterly Progress Report is due.

4) Quarterly Task Order Technical Progress Report

2 electronic Same as CO and COTR above

15th calendar day of the month following the end of each 3 month performance period. The Quarterly Progress Report will not be required on months when an Annual Progress Report is due.

5) Annual and Task Order Technical Progress Report

The Annual and Task Order Technical Progress report shall address each of the below items and be cross-referenced to the WBS in the Gantt chart and IPDP.

1. An Executive Summary highlighting the progress, issues, and

Same as CO and COTR above

Reports shall be submitted 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. Progress reports are not required for the periods when the Annual relevant activities in manufacturing, non-clinical, clinical, and regulatory.

The Executive Summary should highlight only critical issues for that reporting period and resolution approach

2. Progress in meeting contract milestones2 - 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/IPDP.

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

a. 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 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.

Report(s) and Final Report is due.

6) Draft Final Technical Progress Report

2 electronic Same as CO and COTR above

30 calendar days before the completion date of the task order

7) Final Technical Progress Report

2 electronic Same as CO and COTR above

On or before the expiration date of the task order

8) Summary of Salient Results 2 electronic Same as CO and COTR above

On or before the expiration date of the task order

Other Technical Reports

9) Draft and Final Non-Clinical Study Report

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

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

3. Draft and Final protocols and critical reagents

4. Draft and Final Reports

Same as CO and COTR above

Draft documents shall be submitted to BARDA for review and comment.

BARDA will provide feedback within 5 business days. Contractor shall submit all final technical documents within 5 calendar days of completion or as mutually agreed to during the program execution with the

COTR.

Final documents shall be submitted 30 calendar days after receipt of BARDA comments.

Other Reports

10) Animal Model protocols developed or refined under this task order

2 electronic Same as CO and COTR above

Within 14 calendar days of task order issuance.

11) Animal Model Raw Data 2 electronic Same as CO and COTR above

To be determined by USG based upon scope of the task order.

12) Draft Study, qualification and Validation Study reports with Statistical Analyses

2 electronic Same as CO and COTR above

Within 14 calendar days of report completion.

13) Final Study, qualification and Validation Study reports with Statistical Analyses

2 electronic Same as CO and COTR above

Within 14 calendar days of report completion.

14) FDA Correspondence and Meeting Summaries

The contractor shall forward initial contractor and CBER-issued draft minutes and final minutes of any meeting with the FDA to BARDA.

All documents shall be duly marked as either 'Draft' or 'Final'.

Same as COTR Within 5 calendar days of receiving correspondence or meeting minutes from the FDA.

15) FDA Meetings The contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings.

Same as CO and COTR above

As and when scheduled during the task order period of performance

16) FDA Submissions The contractor shall provide BARDA the opportunity to review and comment upon all draft regulatory documents before submission to the FDA. Contractor shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either 'Draft' or 'Final'.

Same as CO and COTR above

BARDA shall provide comment within 5 business days after receipt.

Final FDA submissions shall be submitted to BARDA concurrently or no later than 1 calendar day of its submission to CBER and or CDER as appropriate.

17) Invention Report Annual Utilization Report

2 electronic 1 electronic to OPERA.

CO: 1 electronic

Due on or before the 30th of the month following each anniversary date of the task order.

18) Final Invention Report 2 electronic 1 electronic to OPERA. 1 CO: 1 electronic

Due on or before the completion date of the task order.

19) Draft Final Task Order Report

A draft Final Contract Report containing a summation of the work performed and the results obtained for the entire contract period of performance. The draft report shall be duly marked as 'Draft'.

Same as COTR Due 30 days prior to the completion date of the task order.

20) Final Task Order Report The Final Contract Report incorporating the feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire contract period of performance. The final report shall be duly marked as 'Final'. The Contractor shall submit one (1) copy of a comprehensive final report to the Contracting Officer and two (2) copies (one electronically on a CD) to the COTR. This final report shall detail, document and summarize the results of the entire contract work for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved

Same as CO and COTR above

Due on/before the completion of the task order period of performance.

under all milestones.

21) Milestone Report The Contractor shall provide a Milestone Report with final versions of key project documentation, after the completion of each Milestone unless otherwise agreed upon by the COTR and the Contracting Officer. All documents related to Milestone deliverables shall be submitted to BARDA in draft form for review and comments prior to submittal in final form in the final Milestone Report.

All documents shall be duly marked as either 'Draft' or 'Final'. Milestone reports and monthly reports may be combined if agreed by the COTR and the Contracting Officer

Same as CO and COTR above

Draft Milestone report shall be submitted within 15 calendar days after completion of Milestone. BARDA will provide comments on the Draft Milestone Report within 5 business days after receipt. Contractor shall address all BARDA comments and feedback and submit the Final Milestone Report shall be submitted within 15 calendar days from receipt of BARDA comments

22) Standard Operating Procedures

The contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review electronically.

Same as CO and COTR above

Upon request from the COTR/contracting officer

23) Integrated Product Development Plan (IPDP)

The Contractor shall be required to update the IPDP and include within the IPDP a table matrix capturing all program activities that will generate data and the documents that will be generated from each activity. In response to a need to change the IPDP, the contractor shall provide a deviation report identifying the reason for the deviation and request for change in the agreed upon plan and timelines.

Same as CO and COTR above

Within 10 business days after the task order kick off meeting and following any revisions to the IPDP that occur during the contract Period of Performance. A deviation report shall be submitted as soon as the Contractor has sufficient data to support the need for a change from the approved IPDP.

24) Contractor Audit/Site Visits The contractor shall inform the COTR and Contracting Officer in advance of upcoming audits/site visits of subcontractors as part of the bi-weekly communications, including goals and agenda. Upon completion of the audit/site visit, the contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, details regarding addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution

Reports and responses relating to contractor audits/site visits are due to BARDA within 5 business days of completion.

25) Publications Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to BARDA for review prior to submission

Manuscripts should be submitted to BARDA for review 30 calendar days prior to submission. Abstracts should be submitted to BARDA 15 calendar days prior to submission.

26) Press Release The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases.

The contractor shall ensure that the Contracting Officer has received and approved an advanced copy of any press release related to this task order not less than 4 business days prior to the issuance of the press release.

27) Draft Security Plan 2 electronic Security Specialist: 1 electronic

Within 30 calendar days of task order issuance. BARDA will provide comments on the Draft Security Plan within 5 business days after receipt. Contractor shall address

CO: 1 electronic all BARDA comments and feedback and submit the Final security plan shall within 15 calendar days from receipt of BARDA

28) Security Plan The contractor shall report to the USG any activity or incident that is in violation of established security standards or indicates the loss or theft of government products.

Security Specialist: 1 electronic

CO: 1 electronic

The contractor shall notify the USG within 24 hours after occurrence of activity or incident.

b. The above items shall be addressed and delivered to:

Contracting Officer’s address: AMCG 330 Independence Avenue, S.W.

Room G640

Contracting Officer’s Technical Representative’s address: BARDA

330 Independence Avenue, S.W.

BARDA Security Specialist: Office of the Assistant Secretary for Preparedness and Response Office of Public Health Emergency Medical Countermeasures 409 3rd Street, S.W. Suite 320 Washington, DC 20201 E-mail: james.graham@hhs.gov

Address for the Extramural Inventions and Technology Resources Branch (EITRB), Office of Biodefense Research Affairs:

OPERA

NIH

6705 Rockledge Drive Room 1040-A

MSC 7980

Bethesda, Maryland 20892-7980

F.2. Period of Performance

a. The base period of performance of this contract is anticipated to be 1 year from date of award.

b. Options

The Period of Performance for the base Contract is one year (12 months) from the date of Contract award. The Contract also provides for four additional option periods of one year (12 months) each.

F.3. Reporting Requirements

I. Reports The following reports are subject to the technical inspection and requests for clarification by the COTR. All reports required herein shall be submitted in electronic format. In addition, two (2) hardcopies of each report shall be submitted to the Contracting Officer, unless otherwise specified.

a. Technical Task Order Progress Reports

The contractor shall be required to submit a Task Order Progress Report and the frequency will be specified in Task Order Reporting Requirements during the issuance of a Task Order Request. The Contractor shall submit to the Contracting Officer and COTR technical task order reports covering the work accomplished during each reporting period. The report shall detail the planned progress and actual progress during the period covered, explaining why any differences between the two occurred, and if behind schedule what corrective steps and actions are planned. These reports shall be prepared in accordance with the format described below and in accordance with the DELIVERIES ARTICLE in SECTION F.3.

b. Annual Report

The contractor shall be required to submit an annual technical progress report within 15 days after the anniversary of the contract award date. This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. Additional elements to be included in the Annual Report will be discussed with and approved by the Contracting and/or the COTRs. An annual report will not be required for the period when the final report is due.

c. Final Report

Upon final completion of the contract (with a requirement for a draft final report) a final report shall be submitted. This report is to include summation of work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. Additional elements to b e included in the Annual Report will be discussed with and approved by the Contracting and/or the COTRs.

d. Other reports- in addition to the above reports, the following are considered other reports and deliverables under this contract and will be identified in the Task Order Statement of Work.

1. Animal Model protocols developed or refined under this contract

2. Animal Model Raw Data

3. Draft and Final Study, qualification and Validation Study reports with Statistical Analyses

4. Listing of challenge material, master and working cell banks for cell lines.

e. II. Meetings/Teleconferences and Site Visits/Audits

a. Contract Initiation Meeting

b. Monthly Meetings/Teleconferences (or as needed)

The following types of meetings should be expected and the frequency will be specified in the Task Order Statement of Work.

The Contractor shall perform the following tasks:

1. Within 30 calendar days of the effective date of each Task Order award, participate in a Task Order Initiation Meeting with the COTR, the Contracting Officer and other HHS/BARDA personnel designated by the COTR to be held at a location determined by the COTR. The purpose of the Task Order Initiation Meeting will be to orient the Contractor to HHS/BARDA task order procedures, review contract requirements, and to plan implementation of initial task order activities.

2. Plan and conduct meetings of the Contractor’s Program Director and program team with the

Contracting Officer Technical Representative (“COTR”) and Contracting Officer, including other BARDA personnel deemed appropriate by the COTR, at a minimum of monthly…