RFP-BARDA-08-20 FINAL 12-12-08.pdf

RFP No. HHS-BARDA-08-20

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)

PAGES

`SOLICITATION, OFFER AND

AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 76

2. CONTRACT NO.

3. SOLICITATION NO.

HHS-BARDA-08-20

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

12/12/2008

6. REQUISITION/PURCHASE

NO.

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7) Department of Health and Human Services

OS/ASPR/BARDA

330 Independence Ave. SW, Room G640 Washington, DC 20201

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

SOLICITATION

9. Sealed offers in original and 5 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8 , or if handcarried, in the depository located in Block 7 , See Section L.3.A.(2)(B) until 2:00pm local time 01/27/2009

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

Kim L. Hall

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(202) 205-1587

C. E-MAIL ADDRESS

Kim.Hall@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 19

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 4 X J LIST OF ATTACHMENTS 27

X D PACKAGING AND MARKING 10 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 10 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 10 X OTHER STATEMENTS OF OFFERORS 28

X G CONTRACT ADMINISTRATION DATA 13 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 33

X H SPECIAL CONTRACT REQUIREMENTS 15 X M EVALUATION FACTORS FOR AWARD 56

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

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 / PREVIOUS EDITION IS UNUSABLE STANDARD FORM 33 (REV. 9-97) / Prescribed by GSA / FAR (48 CFR) 53.214(c

K mailto:Kim.Hall@hhs.gov�

ADVANCED DEVELOPMENT OF NEXT GENERATION PORTABLE VENTILATORS

SECTION B--SUPPLIES OR SERVICES AND PRICES/COSTS

For the purposes of this solicitation, the U.S. is defined as the fifty states, the District of Columbia and Puerto Rico, and the terms “Government” and “USG” are collectively defined to mean the Federal Government of the U.S.

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This project from the Department of Health and Human Services (HHS), within the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Influenza and Emerging Diseases Division (IEDD), focuses on the advanced development of domestically manufactured next generation portable fully kitted ventilators, at a cost of <$2,000/ fully kitted unit that will advance the technology to provide respiratory support for large numbers of severely ill patients, during a pandemic influenza outbreak or in an all-hazards (chemical, biological, radiological, nuclear (CBRN) or natural weather related) event in which mass casualties may be expected.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

(a) The estimated cost of this contract is $ .

(b) The fixed fee for this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer and subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

(c) The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee, is $ .

(d) Total funds currently available for payment and allotted to this contract are $ , of which $ represents the estimated costs, and of which $ represents the fixed fee. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

(e) It is estimated that the amount currently allotted will cover performance of the contract through .

(f) The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor.

ARTICLE B.3. CONTRACT LINE ITEM NUMBERS (CLINS)

ITEM SUPPLIES / SERVICES QTY/

UNIT

ESTIMATED

COST

FIXED

FEE

TOTAL EST.

CPFF

0001 Milestone 1 1 Job $ $ $ 0001A Product Development Plan N/A Not Separately

Priced (NSP)

NSP NSP

0001B Design for Fully Functional Prototype, with milestone-driven work plan

N/A NSP NSP NSP

0001C Assembled, Fully Functional Prototype

N/A NSP NSP NSP

0001D Regulatory Master Plan N/A NSP NSP NSP 0002 Milestone 2 1 Job $ $ $ 0002A Document listing and describing

Contractor Defined Milestones

N/A NSP NSP NSP

0002B Integrated Performance Evaluation

N/A NSP NSP NSP

0002C Regulatory Plan w/ Critical Pathways and Clinical Trial Discussions, if applicable, w/

FDA

N/A NSP NSP NSP

0002D Manufacturing Plan N/A NSP NSP NSP 0002E Final Ventilator Specs N/A NSP NSP NSP 0002F Accomplishment of Contractor

Defined Milestones

N/A NSP NSP NSP

0002G Summary Report of Accomplishment of Contractor Defined Milestones

N/A NSP NSP NSP

0003 Milestone 3 1 Job $ $ $ 0003A Feasibility Plan to Manufacture, Regulatory Pathways, Marketing Plans, Including Test and Release

N/A NSP NSP NSP

0003B Send written OEM testing protocols for operational, usability and functional performance and software validation to Government designated Independent Third Party Testing facility as per separate Government contract.

N/A NSP NSP NSP

0003C Test Unit for Independent Testing

N/A NSP NSP NSP

0003D Plan for Two Types of ventilator Testing (clinical and non-clinical)

N/A NSP NSP NSP

0003E Design Verification and Validation w/ Risk Analysis

N/A NSP NSP NSP

0003F Proposed Production Schedules N/A NSP NSP NSP 0003G Analysis of Manufacturing

Capacity to Ramp Up Production

N/A NSP NSP NSP

0003H Warranty Requirements N/A NSP NSP NSP 0004 Milestone 4 1 Job $ $ $ 0004A Customer Support Plan to Test usability in Clinical and Non- Clinical environments

N/A NSP NSP NSP

0004B Update on FDA Pre-market Clearance

N/A NSP NSP NSP

0004C Summary report on final device testing under Milestone 4

N/A NSP NSP NSP

0005 Contractor completion of Project & the Advance Toward FDA Pre-market approval or 510(k) Clearance (Milestone 5)

1 Job $ $ $

0006 Progress Reporting 1 Job $ $ $ 0006A Technical Progress Reports 12

Reports Per Year

NSP NSP NSP

0006B Executive Summary 12 Reports Per Year

NSP NSP NSP

0006C Final Report 1 Report NSP NSP NSP

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

This article prohibits the use of contract funds, unless otherwise approved by the Contracting Officer for the following:

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

2) Special rearrangement or alteration of facilities;

3) Purchase of 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

ARTICLE B.5. 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.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

DEFINITIONS – For the purpose of this Section

“Freedom to Operate” – ensures that the commercial production, marketing and use of the Offeror’s new product, process and service do not infringe the intellectual property rights of others.

“Fully Kitted Ventilator” – ventilator with all necessary components and accessories.

“Intuitive User Interface for ease of use” – easily understood, learned, or grasped by intuition rather than by deductive reasoning; instinctively understood without too much effort.

ARTICLE C.1. OBJECTIVES/STATEMENT OF WORK

(a) OBJECTIVES

Using intellectual property (IP) to which the Contractor has unencumbered and documented access including “Freedom to Operate,” the Contractor shall accomplish the following objectives associated with the contract and new technology:

• All aspects of manufacturing and distributing capabilities for the ventilator and subcomponent parts/accessories shall be compliant with FDA Quality System Regulations requirements and must meet all applicable American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) standards for ventilator, and International Electrical Commission (IEC) standards for critical care ventilators.

• The outcome of the contract is to develop a domestically manufactured next generation portable ventilator that has FDA pre-market clearance.

• Must be able to ramp up production to supply at least a monthly average of 1700 fully kitted ventilators to produce at least 10,000 fully kitted units within 6 months.

• The Contractor and subcomponent contractors/suppliers/vendors must have continuity of operations plans in place at their manufacturing facilities to assure the Government that contracts will be honored during the pandemic influenza outbreak.

• Domestic stockpiles of raw materials and /or parts and components or a contingency plan must be in place to assure availability of product so that contracts will be honored during a pandemic influenza outbreak.

• The original equipment manufacture’s (OEM) warranty for these ventilators shall be in effect on delivery and shall extend for a term of no less than 48 months after the time the ventilator is first used on a patient. The conditions of this warranty may or may not be contingent on the USG’s use of the OEM (or designated/approved service provider) for ongoing maintenance and repair of stockpiled units. Specific, identified consumable components (e.g. batteries) may be excluded from the warranty.

(b) STATEMENT OF WORK

(This Statement of Work is a “placeholder”. The Offeror will propose a Statement of Work for substitution in this location, or alternatively, for reference in this location and in Section J and attachment to the contract. The characteristics in the bulleted list in Article C.1(b)(1) below are recommended or desired by the Government. The Offeror’s proposed Statement of Work should include the characteristics or features that the Offeror is proposing, including any or all characteristics from this list.

The Contractor Work Plan and Gantt chart will also be attached to the contract. Markings that restrict disclosure will be removed from documents attached to the contract. HHS will consider novel approaches developed by the Offeror that support the SOW such as accessory battery pack as the back-up power source, blue tooth transmitters for remote communication, oxygen conserving, etc. Other innovative technology may also be proposed.)

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities not otherwise provided by the Government as needed to perform the work described below.

The work performed will be in accordance with the Contractor Work Plan (CWP) that describes the activities to be performed and a single Gantt chart to include all activities described in the CWP. The level of detail contained in the CWP and the corresponding Gantt chart will be sufficient to facilitate management and execution of the contract by the successful Contractor.

Because borders may be closed during the pandemic influenza outbreak, it is required that the Contractor and subcomponent contractors/suppliers/vendors shall have pandemic influenza plans in place at their manufacturing facilities to show continuity of business operations for manufacturing. The Contractor and subcomponent contractors/suppliers/vendors shall have available raw materials/subcomponent supplies and/or accessories in domestic inventory during a pandemic influenza outbreak to ensure the likelihood that 10,000 fully kitted ventilators can be manufactured within six (6) months to assure that Government contracts may be honored. The Government reserves the right to make visits to the manufacturing and storage facilities prior to contract award and during contract performance to verify compliance with this requirement.

The Contractor shall coordinate the necessary resources to:

(1) Design and assemble a product with defined requirements for treatment of respiratory compromised patients during a pandemic influenza outbreak or in an all-hazards event in which mass casualties may be expected, and when shortages of experienced health care providers with respiratory support training, and shortages of ventilators and accessory components may be expected. The device must be able to provide the same standard of performance as current FDA pre-market cleared portable ventilators and shall have the following additional characteristics or features:

• Low sales price of <$2000/fully kitted unit

• Basic volume flow-controlled unit (minimal)

• A filtration device or adaptable valve to protect against exposure during chemical, biological, radiological, or nuclear (CBRN) events

• Light weight battery with extended battery life that lasts for 4 to 12 hours in all operating modes with the capability to recharge in

2 to 4 hours

• Flexibility to accommodate a wide patient population range from neonate to adult

• Intuitive user interface for ease of use so that inexperienced health care providers with limited or no respiratory support training, can safely and easily use the device.

• Small, lighter weight than current portable ventilators and easily transportable, for storage in the Strategic National Stockpile

(SNS)

• Closed-loop inspiratory pressure control system that can operate with minimal time and attention from staff.

• Accommodate breathing circuits and with universal connectors appropriate to patient population.

• Adequate shielding for radio frequency interference (RFI), electromagnetic interference (EMI), and conductive interference, such as a power surge, and must be demonstrated and tested in appropriate environments.

• Software must be easily upgraded to state-of-the-art to extend the product life-cycle.

• Real time integrated monitoring of O2 saturation, CO2, and respiratory rate

• Stable shelf life and minimal maintenance for stockpiling and use

• Easily recognizable and operational audible and visible alarm systems

• Accommodate a heat and moisture exchanger (HME) or humidifier.

(2) Manufacture and distribute products in compliance with Quality System Regulations requirements for manufacturing and designing (both the manufacturer and the subcomponent contractors/suppliers/vendors), and must meet all applicable American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) standards for portable ventilators, and

International Electrical Commission (IEC) for critical care ventilators. The Contractor must employ and follow a documented design control process. The Contractor Work Plan must include the following:

• The design evolution process with design inputs and outputs must be well planned and documented for comprehensive testing and evaluation planning. Plans should include early operational and pathway assessments in appropriate increments.

• The Contractor must build at least two (2) pre-production fully kitted ventilators to demonstrate manufacturing capabilities to ramp up surge capacity for possible delivery of at least 1700 fully kitted ventilators per month, in a manufacturing facility located in the U.S. to meet the surge capacity goal of at least 10,000 fully kitted ventilators in six (6) months.

• The Contractor and/or subcomponent contractor/suppliers/vendors must have domestic stockpiles of raw materials and/or component parts or a contingency plan in place to assure Government contracts may be honored during a pandemic influenza outbreak.

(3) Engage in independent evaluation testing program(s) and other testing that are accepted by USG as follows:

• Provide fully kitted ventilator for independent third party performance testing to testing facility as designated by USG. OEM protocols for operational, usability, and functional performance testing and software validation protocols shall be provided to the testing facility 15 days before the fully kitted ventilator is shipped to the facility for third party testing. Operational, usability, and functional performance tests shall be inclusive for neonate to adult patient populations. Operational performance shall include but not be limited to all electromagnetic (EMI), radio-frequency (RFI) and conductive interference testing and full review of all executed software validation protocols. Usability performance shall include but not be limited to ease of use and set up type testing for inexperienced health care providers with limited or no respiratory support training and outlines all recommended characteristics and specifications incorporated into the design of the ventilator. Functional performance shall include the Performance Protocol with full functional testing of the ventilator. If the ventilator fails initial testing, it will be immediately returned to the OEM for corrective action and returned to the same testing facility for re-test. The ventilator may have one re-test.

If the ventilator fails the re-test, it shall be returned to OEM and funding may end. Following final testing, the test unit will be retained by the U.S. Government.

• Conducting two (2) types of performance testing: functional testing in a clinical environment in all modes of operation under simulated use conditions in the simulated environment in which the device is expected to be used by inexperienced health care providers with limited or no respiratory support training; and testing in a non-clinical environment for ease of set up and performance, including but not limited to differentiation of audible and visible alarm failure modes by a randomly selected naive audience of 20-40 unskilled users in 3 geographically diverse demographic locales. If a high percentage (98-100%) of these inexperienced/unskilled users pass the set up, performance, and can troubleshoot for recognized audible and visible failure alarm modes, it can be assumed that the fully kitted ventilator meet the definition of “intuitive user interface for ease of use”.

• Finished fully kitted ventilators shall be tested in all operational modes for performance under simulated use conditions in the simulated environment in which the device is expected to be used. Requirements for testing this product shall be in accordance with ASTM F 1100-90 (Standard Specifications for Ventilators Intended for Use in Critical Care), ASTM F 1246-91 (Standard Specification for Electrically Powered Home Care Ventilators, Part 1-Positive-Pressure Ventilators and Ventilator Circuits), and IEC 6061-2-12(Standard for Critical Care Ventilators).

• Performance testing data shall be summarized and submitted to the Project Officer.

Milestones

Milestone 1: Within 45 days from contract award, the Contractor shall provide a detailed Product Development Plan for review and acceptance by the USG. Within 4 months from contract award, the Contractor shall design and assemble a fully functional fully kitted prototype for review and acceptance with a refined milestone-driven Work Plan for the next generation portable ventilator. The Work Plan should be inclusive of performance activities completed prior to contract award and those clinical (as necessary) and manufacturing activities to be performed post-contract award. A Regulatory Master Plan shall be included. The Plan should be a high-level overview and include the following:

A. A Gantt chart for timelines and decision gates for assessing progress by meeting pre-determined metrics. Gantt chart should be in

Microsoft Project format.

B. A description of the Contractor’s clearly defined milestones at which times data will be presented summarizing results of prior activities, metrics used at decision gates and new plans and protocols that will be submitted for review and acceptance.

C. Design and software specifications, design drawings and design and software input and expected output requirements to describe the design evolution process, including early operational and pathway assessments.

D. A summary of protocols to demonstrate operational, usability, and functional performance characteristics of the fully kitted prototype with pre-defined metrics for decision gates.

E. Completion of a hazard analysis based on critical thinking about the device design and the impact of any failure of subsystem components, such as alarm functions, interoperability, system communications, software interface, patient safety and take into account usability or human factors by inexperienced user operator limited abilities.

F. A plan and draft protocol of clinical and/or simulated use performance testing of the fully functional fully kitted prototype in normal use settings under simulated use conditions in simulated environment in which the device is expected to be used by inexperienced care providers with limited or no respiratory support training.

G. A plan and draft protocol for fully kitted ventilator testing for ease of set up, performance and audible and visible alarm failure mode recognition by a randomly selected naive audience of 20-40 unskilled users. If high percentages (98-100%) of these unskilled users pass the set up, performance and audible and visible alarm failure mode recognition, it can be assumed that the fully-kitted ventilator meets the definition of “intuitive user interface for ease of use”.

H. A regulatory master plan that focuses on the critical pathways to 510(k) clearance or pre-market application (PMA) submissions, which ever is applicable according to early consultation with the Center for Devices and Radiological Health (CDRH)/FDA for pathway guidance.

I. A definition of responsibilities of all key personnel for implementation of activities and identify interfaces with different groups or activities. Subcomponent contractor/supplier/vendor information and interface activities should also be included.

J. By completion of Milestone 1, the Contractor shall submit in their monthly report data to show compliance with all applicable standards.

Milestone 2: Within 10 months of contract award, the Contractor shall submit for HHS review and acceptance, comprehensive, integrated Contractor defined milestones showing pre-clinical, regulatory with critical pathways and clinical trial discussions, if applicable, in accordance with FDA consultation, manufacturing plans and final fully kitted ventilator specifications. These plans shall address advanced development for the availability of domestically manufactured next generation portable ventilators:

A. A summary of the need for operational and functional performance testing including specifics in regards to consultations with

CDRH/FDA should be incorporated as an appendix to the milestone report.

B. A detailed report of operational, usability, and functional performance testing (completed during this milestone). Performance testing should include simulated use testing of the finished fully kitted ventilator in the simulated environment in which the device is expected to be used. Testing shall include all patient populations, for which the ventilator is designed, e.g., neonate to adult. All components for testing shall be specified and fully documented supporting feasibility for further testing and transfer to production.

C. Plans and critical pathways to achieve final goals for manufacturing and production under U.S. Quality Systems Regulations (21

CFR Part 820; see Medical Device Quality Systems Manual: A Small Entity Compliance Guide, April 14, 1999 available at http://www.fda.gov/cdrh/qsr/01qsreg.html

D. A report with final specifications following optimization of the fully kitted ventilator test system based on operational, usability, and functional performance testing, design controls and software verification. Include projected shelf life of key components that may degrade over time or software which may require upgrading at intervals.

E. A detailed description of regulatory activities shall be integrated with testing and manufacturing activities using the most current and available information, including consultation with CDRH.

Milestone 3: Within 16 months of contract award, the Contractor shall submit for review and acceptance, a milestone-driven Feasibility Plan that integrates simulated use evaluation, manufacturing, regulatory and marketing plans to include testing and release of product. Other activities in this milestone include independent third party testing activities. Plans and activities shall include:

http://www.fda.gov/cdrh/qsr/01qsreg.html�

A. Implementing a clinical protocol for innovative components as needed (reviewed and evaluated by FDA/CDRH) that clearly indicates key outcomes, including neonate to adult populations, study sites, collaborators, analytic strategy, sample size, timelines and key components.

B. Sending written OEM testing protocols for operational, usability, and functional performance testing and software validation to the USG designated independent third party testing facility 15 days before shipping the fully kitted ventilator to the facility for testing.

C. If any discrepancies/failures are revealed at the time of third party testing, the ventilator is immediately returned to the OEM for corrective action. The PO will advise the OEM of the need for corrective action and advise of the timeline for resolution before return for re-testing at the third party testing facility. If ventilator fails a second time, this failure may be an indication under the Termination clause of the contract that the Contractor has failed to make progress so as to endanger performance of the contract.

C. Preparing a report on completed clinical evaluations or simulated use evaluations that may be submitted to FDA.

D. Developing marketing strategy that identifies training needs for inexperienced health care providers with limited or no respiratory support training that addresses issues for integrating use and testing.

E. Developing a plan to analyze and assess the capability for fully kitted ventilator testing for safe and effective use by inexperienced health care providers with limited or no respiratory support training in clinical and non-clinical environments.

F. Analyzing the device design verification and validation and conduct a risk analysis to determine problems that may require design changes.

G. Preparing proposed production schedules including detailed timelines for each production step.

H. Manufacturing capacity analysis to ensure the ability to ramp up production to meet surge requirements.

I. Finalizing warranty requirements that state implicitly that it will be in effect on delivery and shall extend for a term of no less than 48 months after the time the ventilator is first used on a patient. It should state that the conditions of the warranty may or may not be contingent on the USG’s use of the OEM (or designated/approved service provider) for ongoing maintenance and repair of stockpiled units. Specific, identified consumable components (e.g. batteries) may be excluded from the warranty.

Milestone 4: Within 22 months of contract award, the Contractor shall submit for review and acceptance the final testing used in clinical and non-clinical environments.

The Contractor shall submit for review and acceptance a Customer Support Plan. This plan shall be time-phased and the Contractor will work with a health care institution to test the next generation portable ventilator with test lung simulators. The Contractor shall provide all necessary equipment, educational materials, and technical support that targets physicians and nurses who are not trained in respiratory care. The testing will occur over two (2) months in a clinical environment in which the device is intended to be used. Test reports shall include usability and clinical utility information gathered from the participants.

In addition, usability performance testing directed toward a randomly selected naive audience of 20-40 unskilled users in three (3) geographically diverse demographic locales should be conducted but not limited to ease of set up, performance and audible and visible alarm failure mode recognition. If high percentages (98-100%) of these naïve unskilled users pass the set up, performance and recognition for audible and visible alarm failure modes, it can be assumed that the fully kitted ventilator meets the definition of “intuitive user interface for ease of use”.

The Customer Support Plan must include the following:

a.) The design and approach for implementing training b.) Collaborating with clinical experts to develop clinician education materials and inexperienced health care providers with limited or no respiratory support training materials.

c.) Input from clinical and non-clinical testing should be compared and documented accordingly.

d.) A health hazard evaluation and analysis should be incorporated.

The following should be attached to the Customer Support Plan:

a.) Final product labels (including package inserts) and plain English language with illustrated instructions physically attached to the ventilator with a security type mechanism to prevent removal.

b.) DVD and accompanying user instruction manuals for training and educational materials developed to date.

c.) Promotional materials developed.

A summary report must include comparison results from testing the ventilator in clinical and non-clinical environments, collaborative meetings with clinical experts to determine training and educational material requirements in the clinical environment for the inexperienced health care provider with limited or no respiratory support training and the non-clinical environment with the naïve unskilled user; final product labeling, including user instructions in plain English language with illustrated instructions that will be physically attached to the ventilator to prevent removal, DVD and accompanying user instruction manual and other promotional materials. In addition, the Contractor shall provide an update on FDA pre-market clearance activities.

Milestone 5: Within 24 months, the Contractor shall reach completion of the project and shall provide a completed project final report including FDA pre-market approval or 510(k) clearance information.

ARTICLE C.2. REPORTING REQUIREMENTS

In addition to those reports required by other terms of this contract, the Contractor(s) shall submit to the Contracting Officer and the Project Officer technical progress reports covering the work accomplished during each reporting period on a periodic basis as established by the Project Officer. These reports are subject to the technical inspection and requests for clarification by the Project Officer. These reports shall be brief and factual and prepared in accordance with the following format:

I. Technical Progress Reports: On the tenth of each month for the previous calendar month, the Contractor shall submit a report to the Project Officer and Contracting Officer. The format and type of Technical Progress Report and Executive Summary will be provided by the Project Officer. Technical Progress Reports will include project timelines and milestones and summaries of product manufacturing, testing and evaluations. A Technical Progress Report will not be required for the period when the Final Report is due.

The Contractor shall submit one copy of the Technical Progress Report electronically, an original and three paper copies. Reports and their appendices shall be submitted in Microsoft Word, Microsoft Excel, Microsoft Project and/or Adobe Acrobat PDF files. Such reports shall include the following specific information:

A. Title page containing Technical Progress Report, 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;

B. Introduction/Background – An introduction covering the purpose and scope of the contract effort;

C. Progress – The report shall detail, document and summarize the results of work performed, test results and milestones achieved during the period covered. Also to be included is a summary of work planned for the next reporting period.

D. Issues – Issues resolved, new issues and outstanding issues are 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 are provided.

E. A summary of the meetings, conference calls and workshops that have taken place during the reporting period.

F. Invoices – Summary of any invoices submitted during the reporting period including personnel and material charges in keeping with the Work Breakdown Structure for the respective tasks in the overall Work Plan.

G. Action Items – Summary table of activities or tasks by a certain date and by whom.

H. Distribution List – A list of persons receiving the Technical Progress Report.

I. Attachments – Reports (with data) or protocols developed on the project are provided as attachments.

II. The Executive Summary: which shall accompany each Technical Progress Report, shall be formatted in Microsoft Power Point presentation and include the following:

A. Title page containing Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor’s name and the date of the submission;

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

C. Project issues presented headings and each item as a talking point bullet.

III. Final Report: The Final Report shall be submitted to the Project Officer by no later than the contract completion date. The report shall detail, document and summarize the results of the entire contract work and include the following:

A. Summaries of all analytical, pre-clinical, clinical data generated under the contract, with line data attached if not previously provided.

B. Copies (paper and electronic) of protocols, methods, Standard Operating Procedures (SOPs) and other materials generated under the contract.

C. A summary of the Intellectual Property and similar agreements made by the Contractor with outside parties which may impact distribution or commercial use of the device.

D. Final labeling, packaging, product release documentation and other information and materials supporting completion of the objective.

E. Summaries of warranty and future maintenance/service needs and part change outs as required according to manufacturer’s recommendations. Maintenance/service activities shall be presented based on period of time and split out as “required” and “recommended”. The Contractor shall provide a detailed service program that addresses both active periodic use of the ventilator, as well as shelved conditions.

SECTION D – PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. SHIPPING

I. Method of Delivery

Unless otherwise specified by the Contracting Officer or the Contracting Officer’s representative, delivery of items, to be furnished to the Government under this contract (including invoices) shall be made by first class mail. All deliverables shall be marked with the contract number and Contractor name.

II. Addresses – For all contract deliverables.

Project Officer Contracting Officer

HHS/OS/ASPR/BARDA HHS/OS/ASPR/BARDA

330 Independence Avenue, SW 330 Independence Avenue, SW Room G640 Room G640 Washington, DC 20201 Washington, DC 20201

SECTION E – INSPECTION AND ACCEPTANCE

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided under the contract. The contract will identify who will perform inspections and where the inspections will be performed.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

The following clause is incorporated by reference with the same force and effect as if it were given in full text.

FAR Clause No.52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM) (APR 1984)

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract is from the date of contract award to 24 months after contract award.

ARTICLE F.2. TECHNICAL REPORT DISTRIBUTION

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 dates specified below and any SHIPPING specifications stated in SECTION D of this contract:

Item Description Quantity Due Date 0006A Technical Progress Report Original – CO

3 Copies – PO 1 Electronic Copy – PO

1st Report due on/before the 10th day of the month following the month of contract award;

thereafter, due on/before the 10th of the month or milestone following each reporting period in Article C.2. Not due when Final Report is due.

0006B. Executive Summary Original – C.O.

3 Copies – PO 1 Electronic Copy – PO

1st Report due on/before the 10th day of the month following the month of contract award;

thereafter, due on/before the 10th of the month following each reporting period in Article C.2. Not due when Final Report is due.

0006C Final Report Original – CO 3 Copies – PO 1 Electronic Copy – P.O.

Due on/before the completion date of the contract.

ARTICLE F.3. OTHER CONTRACT DELIVERABLES

The items specified below as described in Article C.1 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 dates specified below and any SHIPPING specifications stated in SECTION D of this contract:

[NOTE: Offeror is to propose Due Dates for Items 0002C and 0002D that are no more than 16 months after contract award.]

Item Deliverable Quantity Due Date 0001A Product Development Plan Original – CO

3 Copies – PO 1 Electronic Copy – PO

Within 45 days after contract award

0001B Design for Fully Functional Prototype, with milestone-driven work plan

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within four months after contract award

0001C Assembled, Fully Functional Prototype One (1) Within four months after contract award

0001D Regulatory Master Plan Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within four months after contract award

0002A Document listing and describing Contractor Defined Milestones

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 10 months after contract award

0002B Integrated Performance Evaluation Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 10 months after contract award

0002C Regulatory Plan w/ Critical Pathways and Clinical Trial Discussions, if applicable, w/ FDA

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within ___ months after

0002D Manufacturing Plan Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within ___ months after contract award

0002E Final Ventilator Specs Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after contract award

0002F Summary Report of Accomplishment of Contractor Defined Milestones

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after contract award

0003A Feasibility Plan to Manufacture, Regulatory Pathways, Marketing Plans, Including Test and Release

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after

0003B Send written OEM testing protocols for operational, usability and functional performance and software validation to Government designated Independent Third Party Testing facility as per separate Government contract.

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Send testing protocols to third party testing facility 15 days before sending fully kitted ventilator for testing.

0003C Test Unit for Independent Testing One (1) Within 16 months after contract award, including return to testing facility following return to OEM for failed test

0003D Plan for Two Types of ventilator Testing (clinical and non-clinical)

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after contract award

0003E Design Verification and Validation w/ Risk Analysis

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after

0003F Proposed Production Schedules

Original – CO

1 Electronic Copy – PO

Within 16 months after contract award

0003G Analysis of Manufacturing Capacity to Ramp Up Production

Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after contract award

0003H Warranty Requirements Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 16 months after contract award

0004A Customer Support Plan to Test usability in Clinical and Non-Clinical environments

Original – CO

1 Electronic Copy – PO

Within 22 months after contract award

0004B Update on FDA Pre-market Clearance Original – CO 3 Copies – PO 1 Electronic Copy – PO

Within 22 months after contract award

0005 Contractor completion of Project & the Advance Toward FDA Pre-market approval or 510(k) Clearance

Original – CO

1 Electronic Copy – PO

Within 24 months after

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

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. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FAR CLAUSE 52.242-15, STOP WORK ORDER (AUG 1989) with ALTERNATE I (APR 1984)

SECTION G – CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER

The Contracting Officer is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) legally commit the Government to the expenditure of public funds; (2) direct or negotiate any changes in the statement of work; (3) modify or extend the period of performance; (4) change the delivery schedule; (5) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (6) otherwise change any terms and conditions of this contract.

No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from this contract.

ARTICLE G.2. PROJECT OFFICER

The Government's Project Officer(s) will be identified in the contract.

The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its Project Officer designation.

ARTICLE G.3. KEY PERSONNEL, HHSAR 352.270-5 (JANUARY 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individual(s) are considered to be essential to the work being performed hereunder:

NAME TITLE

[To Be Specified Prior To Award]

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

Invoice/Financing Request instructions are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures to meet the requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment. Addresses for submitting invoices will be included in the contract.

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

ARTICLE G.5. CONTRACT FINANCIAL REPORT

a. Financial reports shall be submitted by the Contractor to the address specified in Block 7 on the face page of the contract.

b. The first financial report shall cover the period consisting of the FIRST FULL THREE CALENDAR MONTHS following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a quarterly basis.

c. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

d. The following is a listing of expenditure categories to be reported:

Expenditure Category

(1) Direct Labor

(a) Principal Investigator

(b) Co-Principal Investigator

(c) Key Personnel (i) (ii) (iii)

(2) Other Professional Personnel

(3) Personnel - Other

(4) Fringe Benefits

(5) Accountable Personal Property

(6) Materials/Supplies

(7) Patient Care Costs

(8) Travel

(9) Consultant Costs

(10) Premium Pay

(11) Computer Costs

(12) Subcontract Costs

(13) Other Direct Costs

(14) Indirect Costs

(15) G&A Expense

(16) Total Cost

(17) Fee

(18) Total Cost Plus Fixed Fee

e. The Government may unilaterally revise the expenditure categories.

ARTICLE G.6. INDIRECT COST RATES

Profit making organizations will negotiate provisional and/or final indirect cost rates with their cognizant Government Agency.

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the pre-award negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, “Contractor's Guide for Control of Government Property”, which can be found at:

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf�

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. Interim and final evaluations will be submitted to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted 30 days to review the document and to submit additional information or a rebutting statement. Copies of the evaluations, Contractor responses and review comments, if any, will be retained as part of the contract file and may be used to support future award decisions.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this contract until the protocol developed in Phase I has been approved by the Department of Health and Human Services, written notice of such approval has been…