SSTD BAA Document 20 June 09

Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development BARDA Science and Technology Announcement Soliciting Advanced Research & Development Proposals

BARDA-BAA-09-100-SOL-0010

Biomedical Advanced Research and Development Authority (BARDA)

330 Independence Avenue, SW, Rm G640

Washington, DC, 20201

TABLE OF CONTENTS

Table Of Contents Overview Information

Introduction Background SSTD Areas of Interest Instructions to Offerors Terms and Conditions Reporting Requirements and Deliverables Evaluation Factors Attachment #1 White Paper Format Attachment #2 Industry Day/Pre-Proposal Conference Overview Information

Agency Name: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201 Issuing Office: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA) 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201 Opportunity Title: Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development. (Innovations BAA) Eligible Applicants: This BAA is open to all responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, Federally Funded Research and Development Centers (FFRDCs), and academic institutions.

Federally Funded Research and Development Centers (FFRDCs) are eligible to respond to this BAA, individually or as a team member of an eligible principal Offeror, as so long as they are permitted under the sponsoring agreement between the Government and the specific FFRDC.

Historically Black Colleges and Universities (HBCU), Minority Institutions (MI), Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUB Zone Small Business concerns are encouraged to submit proposals and to join other entities as team members in submitting proposals. However, this BAA will not be set-aside pursuant to FAR Part 19.502-2.

Awards: BARDA anticipates awarding multiple contracts and/or cooperative agreements for research and development efforts from this BAA that have sufficient potential for success; are of interest to BARDA; and support one or more of the listed SSTD Areas of Interest. The contract type will be selected on most suitable for the effort proposed and with consideration of the Offeror’s request.

Contact/Submission Information: Potential Offerors are encouraged to ask questions regarding this announcement. All correspondence, including white papers and proposal submissions shall be sent to the contracting officer as follows unless otherwise specified.

Anthony S. Kram, Contracting Officer (CO) Phone: 202-205-4709

Fax: 202-205-6061

Email: Anthony.Kram@hhs.gov 330 Independence Avenue, SW, Rm G640

Washington, DC, 20201 Open Period: This BAA is a continuously open valid throughout the period from the date of issuance for 12 consecutive months, unless otherwise amended. Interested parties are encouraged to periodically check the FBO website for updates and amendments.

Introduction This BARDA Research Announcement, a form of Broad Agency Announcement (BAA), solicits innovative science and technology proposals that fall within several broad platform Strategic Science and Technology Division (SSTD) Areas of Interest with application to medical countermeasure (MCM) development. Specific interest exists in the promotion of science and technology advancements focused on (1) product development improvements to enhance the safety, efficacy, and ease of use of medical countermeasures (MCM), (2) reduction in the time and cost of MCM development, evaluation, and manufacturing, and (3) advanced development of innovative diagnostic platforms for the rapid detection of priority pathogens. The specific application of the platform technologies focused on biodefense, chemical, biological, radiological and nuclear (CBRN) agents and emerging infectious disease (EID) threats, including pandemic flu, particularly as applied to candidate products in late stages of product development. BARDA anticipates demonstration of the utility of these novel platforms in biodefense and EID that generate validated data suitable for comparability analysis with candidate products and that have direct application to commercial-scale manufacturing or testing processes. The development activities are to be fully integrated with regulatory activities associated with product development efforts. This BAA is issued pursuant to competitive acquisition procedures as described in paragraph 6.102(d)(2) of the Federal Acquisition Regulation (FAR).

Background The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA’s mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN), in support of the preparedness mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) articulated in the PHEMCE Implementation Plan for CBRN Threats and the National Strategy for Pandemic Influenza. The Implementation Plan for CBRN agents is located on the Assistant Secretary for Preparedness and Response (ASPR) website http://www.hhs.gov/aspr/barda/phemc/index.html and the National Strategy for Pandemic Influenza on the website http://www.pandemicflu.gov.

The Pandemic and All Hazard Preparedness Act (PAHPA) directs BARDA to promote (i) innovations in technologies that may assist countermeasure and product advanced research and development, (ii) research on and development of research tools and other devices and technologies, and (iii) research to promote strategic initiatives. Through this Broad Agency Announcement (BAA), BARDA seeks to advance the technological and scientific advancements of medical countermeasures for biodefense CBRN and emerging infectious disease threats, including pandemic influenza. The PAHPA is located on the ASPR website http://www.hhs.gov/aspr/opsp/pahpa/index.html.

This Broad Agency Announcement (BAA) is specifically designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SSTD) of BARDA and will be open to all responsible Offerors.

SSTD Areas of Interest Through this Broad Agency Announcement, BARDA seeks to promote science and technology advancement in the following applied SSTD Areas of Interest:

SSTD Area of Interest #1: Technologies to accelerate evaluation of candidate vaccines and therapeutics

1.1 In vitro evaluation systems for structural and/or functional characterization of protein modifications (e.g., immunodominant epitopes, neutralizing antibody, etc.) useful for process analytical testing and/or regulatory release of candidate products.

1.2 Evaluation of ex vivo systems to evaluate immune priming and/or functional immunological characterization of responses that are predictive of immunogenicity in vivo concomitant with advanced development activities of product candidates.

SSTD Area of Interest #2: Formulation chemistry, protein stabilization, and vaccine delivery technologies

2.1 Advanced development of novel adjuvants and/or delivery systems to optimize an effective and rapid immune response to candidate products after a single dose.

2.2 Advanced development of candidate product formulation and protein stabilization for vaccines and therapeutics to improve shelf-life of final drug product, including stability at controlled room temperature.

SSTD Area of Interest #3: Innovative methods in bioprocess development and manufacturing

3.1 Novel methods for analytical characterization of biomaterials (e.g., complex proteins) for identity, purity, and potency.

3.2 Innovative platforms for accelerated, high-yield, standardized manufacture of biological vaccines and therapeutics.

SSTD Area of Interest #4: Methods and technologies to advance development of diagnostic tests for rapid diagnosis of human infections

4.1 Development of molecular analyses that facilitate the design, production, and commercialization of diagnostic devices or systems.

4.2 Optimizing the engineering design and integration of instrumentation and analysis algorithms to provide for a rapid and accurate diagnostic test result.

4.3 Optimizing and validating reference materials and analytical methods that can facilitate efficient and economical production of biological reagents for use in diagnostic test systems.

4.4 Characterization and evaluation of novel methods for collecting and processing human specimens for diagnostic testing.

Note: Individual proposals may address any Area of Interest but not multiple areas. Submit a separate proposal for each Area of Interest.

Instructions to Offerors and Proposal Preparation Information

1. White Papers: Offerors shall submit white papers to the Government for an initial assessment and determination of interest and fit within the BARDA mission. The white paper shall summarize the proposed project focusing on the technical description. All white papers shall be prepared in accordance with the instructions contained in Attachment 1. Brochures or other descriptions of general organizational or individual capabilities will not be accepted. Acknowledgement of receipt (electronic) will be made within one week. Offerors will be notified of their status after the cycle review is complete. Offerors whose white papers have a favorable evaluation assessment will be invited to submit a full proposal. White papers may be shared with other Government agencies.

2. White Paper Evaluation: White papers will be evaluated subjectively by a peer review or panel of experts to determine if the proposed technology presents 1) sufficient scientific or technological innovation/merit that is programmatically relevant to BARDA’s mission, 2) fits within one of the identified SSTD Area of Interests, and 3) offers a relatively good potential for success will be invited to provide a full proposal for evaluation.

3. Submission Schedule: White Papers may be submitted at any time during the open period of the BAA. However, BARDA anticipates holding four evaluation cycles per year with submission deadlines of 1 September, 1 December, 1 March, and 1 June. White papers submitted prior to the next sequential deadline will be evaluated in that cycle. White papers submitted at any time during a cycle period shall remain effective for a minimum of 90 days past the next scheduled cycle deadline unless withdrawn.

4. Submission Format: White papers may be submitted electronically by email (preferred) or by mail to the Contracting Officer identified on page 3.

5. Full Proposals: Offerors invited to submit a full proposal will be provided additional instructions at time of invitation regarding submission times, format, restrictions and any special instructions.

6. Bid and Proposal Costs: All proposals submitted are voluntary on the part of the Offeror and costs associated with the white paper and/or proposal process are bourn solely by the Offeror. The Government will not reimburse or pay bid and proposal costs.

7. Security: Classified proposals will not be accepted.

8. Conflict Of Interest: There are certain post employment restrictions on former federal officers and employees, including special government employees (Section 207 of Title 18, U.S.C.). If a prospective Offeror believes a conflict of interest may exist, the Contracting Officer shall be notified of the situation prior to preparing a proposal.

9. Intellectual Property: For issued patents or published patent applications that will be used in the performance of this effort, provide the patent number or patent application publication number, a summary of the patent or invention title, and indicate whether the Offeror is the patent or invention owner.

10. Funding Profile: The Government anticipates making 4-8 awards per fiscal year ranging from $2-10 million each. Dollar amount and quantity of awards may vary depending on scientific merit and available funds. Funding is not currently available.

Terms and Conditions

Terms and conditions will be tailored for each contract award depending on nature of effort proposed, complexity, type of contract, business size/type, applicable laws and consideration of the Offeror’s specific request. However; based on the nature of the field of research and development, the following list of terms and conditions should be expected to be included in all resultant awards of this BAA in some form, if applicable. This list is not all inclusive.

HHSAR 352.270-8 PROTECTION OF HUMAN SUBJECTS (JAN 2006)

(a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Office of Public Health and Science (OPHS). The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

(b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

(c) If at any time during the performance of this contract, the Contracting Officer determines, in consultation with the OHRP, OPHS, ASH, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OHRP, OPHS, ASH, terminate this contract in a whole or in part, and the Contractor’s name may be removed form the list of those contractors with approved Health and Human Services Human Subject Assurances.

HHSAR 352.270-9 CARE OF LIVE VERTEBRATE ANIMALS (JAN 2006)

(a) Before undertaking performance of any contract involving animal related activities the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care and use of any live vertebrate animals used or intended for use in the performance of this contract will conform with the PHS Policy on Humane Care of Use of

HYPERLINK "http://grants.nih.gov/grants/olaw/references/phspol.htm" Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of

HYPERLINK "http://www.nap.edu/readingroom/books/labrats/contents.html" Laboratory Animals prepared by the Institute of Laboratory Animal Resources and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR

HYPERLINK "http://www.access.gpo.gov/nara/cfr/waisidx_03/9cfrv1_03.html" Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall be used.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved PHS Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.

HHSAR 352.270-14 RESTRICTION ON USE OF HUMAN SUBJECTS (JAN 2006)

Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research involving human subjects or engage in any human subjects research activity prior to the receipt by the Contracting Officer of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) designated under the Contractor’s Federal-wide assurance of compliance. This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors.

FAR 52.227-14 Rights in Data—General.

(a) Definitions. As used in this clause—

“Computer database” or “database means” a collection of recorded information in a form capable of, and for the purpose of, being stored in, processed, and operated on by a computer. The term does not include computer software.

“Computer software”—

(1) Means

(i) Computer programs that comprise a series of instructions, rules, routines, or statements, regardless of the media in which recorded, that allow or cause a computer to perform a specific operation or series of operations; and

(ii) Recorded information comprising source code listings, design details, algorithms, processes, flow charts, formulas, and related material that would enable the computer program to be produced, created, or compiled.

(2) Does not include computer databases or computer software documentation.

“Computer software documentation” means owner’s manuals, user’s manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

“Data” means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

“Form, fit, and function data” means data relating to items, components, or processes that are sufficient to enable physical and functional interchangeability, and data identifying source, size, configuration, mating and attachment characteristics, functional characteristics, and performance requirements. For computer software it means data identifying source, functional characteristics, and performance requirements but specifically excludes the source code, algorithms, processes, formulas, and flow charts of the software.

“Limited rights” means the rights of the Government in limited rights data as set forth in the Limited Rights Notice of paragraph (g)(3) if included in this clause.

“Limited rights data” means data, other than computer software, that embody trade secrets or are commercial or financial and confidential or privileged, to the extent that such data pertain to items, components, or processes developed at private expense, including minor modifications.

“Restricted computer software” means computer software developed at private expense and that is a trade secret, is commercial or financial and confidential or privileged, or is copyrighted computer software, including minor modifications of the computer software.

“Restricted rights,” as used in this clause, means the rights of the Government in restricted computer software, as set forth in a Restricted Rights Notice of paragraph (g) if included in this clause, or as otherwise may be provided in a collateral agreement incorporated in and made part of this contract, including minor modifications of such computer software.

“Technical data” means recorded information (regardless of the form or method of the recording) of a scientific or technical nature (including computer databases and computer software documentation). This term does not include computer software or financial, administrative, cost or pricing, or management data or other information incidental to contract administration. The term includes recorded information of a scientific or technical nature that is included in computer databases (See 41 U.S.C. 403(8)).

“Unlimited rights” means the rights of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

(b) Allocation of rights.

(1) Except as provided in paragraph (c) of this clause, the Government shall have unlimited rights in—

(i) Data first produced in the performance of this contract;

(ii) Form, fit, and function data delivered under this contract;

(iii) Data delivered under this contract (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this contract; and

(iv) All other data delivered under this contract unless provided otherwise for limited rights data or restricted computer software in accordance with paragraph (g) of this clause.

(2) The Contractor shall have the right to—

(i) Assert copyright in data first produced in the performance of this contract to the extent provided in paragraph (c)(1) of this clause;

(ii) Use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, unless provided otherwise in paragraph (d) of this clause;

(iii) Substantiate the use of, add, or correct limited rights, restricted rights, or copyright notices and to take other appropriate action, in accordance with paragraphs (e) and (f) of this clause; and

(iv) Protect from unauthorized disclosure and use those data that are limited rights data or restricted computer software to the extent provided in paragraph (g) of this clause.

(c) Copyright—

(1) Data first produced in the performance of this contract.

(i) Unless provided otherwise in paragraph (d) of this clause, the Contractor may, without prior approval of the Contracting Officer, assert copyright in scientific and technical articles based on or containing data first produced in the performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. The prior, express written permission of the Contracting Officer is required to assert copyright in all other data first produced in the performance of this contract.

(ii) When authorized to assert copyright to the data, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number).

(iii) For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly by or on behalf of the Government. For computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public) by or on behalf of the Government.

(2) Data not first produced in the performance of this contract. The Contractor shall not, without the prior written permission of the Contracting Officer, incorporate in data delivered under this contract any data not first produced in the performance of this contract unless the Contractor—

(i) Identifies the data; and

(ii) Grants to the Government, or acquires on its behalf, a license of the same scope as set forth in paragraph (c)(1) of this clause or, if such data are restricted computer software, the Government shall acquire a copyright license as set forth in paragraph (g)(4) of this clause (if included in this contract) or as otherwise provided in a collateral agreement incorporated in or made part of this contract.

(3) Removal of copyright notices. The Government will not remove any authorized copyright notices placed on data pursuant to this paragraph (c), and will include such notices on all reproductions of the data.

(d) Release, publication, and use of data. The Contractor shall have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, except—

(1) As prohibited by Federal law or regulation (e.g., export control or national security laws or regulations);

(2) As expressly set forth in this contract; or

(3) If the Contractor receives or is given access to data necessary for the performance of this contract that contain restrictive markings, the Contractor shall treat the data in accordance with such markings unless specifically authorized otherwise in writing by the Contracting Officer.

(e) Unauthorized marking of data.

(1) Notwithstanding any other provisions of this contract concerning inspection or acceptance, if any data delivered under this contract are marked with the notices specified in paragraph (g)(3) or (g) (4) if included in this clause, and use of the notices is not authorized by this clause, or if the data bears any other restrictive or limiting markings not authorized by this contract, the Contracting Officer may at any time either return the data to the Contractor, or cancel or ignore the markings. However, pursuant to 41 U.S.C. 253d, the following procedures shall apply prior to canceling or ignoring the markings.

(i) The Contracting Officer will make written inquiry to the Contractor affording the Contractor 60 days from receipt of the inquiry to provide written justification to substantiate the propriety of the markings;

(ii) If the Contractor fails to respond or fails to provide written justification to substantiate the propriety of the markings within the 60-day period (or a longer time approved in writing by the Contracting Officer for good cause shown), the Government shall have the right to cancel or ignore the markings at any time after said period and the data will no longer be made subject to any disclosure prohibitions.

(iii) If the Contractor provides written justification to substantiate the propriety of the markings within the period set in paragraph (e)(1)(i) of this clause, the Contracting Officer will consider such written justification and determine whether or not the markings are to be cancelled or ignored. If the Contracting Officer determines that the markings are authorized, the Contractor will be so notified in writing. If the Contracting Officer determines, with concurrence of the head of the contracting activity, that the markings are not authorized, the Contracting Officer will furnish the Contractor a written determination, which determination will become the final agency decision regarding the appropriateness of the markings unless the Contractor files suit in a court of competent jurisdiction within 90 days of receipt of the Contracting Officer’s decision. The Government will continue to abide by the markings under this paragraph (e)(1)(iii) until final resolution of the matter either by the Contracting Officer’s determination becoming final (in which instance the Government will thereafter have the right to cancel or ignore the markings at any time and the data will no longer be made subject to any disclosure prohibitions), or by final disposition of the matter by court decision if suit is filed.

(2) The time limits in the procedures set forth in paragraph (e)(1) of this clause may be modified in accordance with agency regulations implementing the Freedom of Information Act (5 U.S.C. 552) if necessary to respond to a request there under.

(3) Except to the extent the Government’s action occurs as the result of final disposition of the matter by a court of competent jurisdiction, the Contractor is not precluded by paragraph (e) of the clause from bringing a claim, in accordance with the Disputes clause of this contract, that may arise as the result of the Government removing or ignoring authorized markings on data delivered under this contract.

(f) Omitted or incorrect markings.

(1) Data delivered to the Government without any restrictive markings shall be deemed to have been furnished with unlimited rights. The Government is not liable for the disclosure, use, or reproduction of such data.

(2) If the unmarked data has not been disclosed without restriction outside the Government, the Contractor may request, within 6 months (or a longer time approved by the Contracting Officer in writing for good cause shown) after delivery of the data, permission to have authorized notices placed on the data at the Contractor’s expense. The Contracting Officer may agree to do so if the Contractor—

(i) Identifies the data to which the omitted notice is to be applied;

(ii) Demonstrates that the omission of the notice was inadvertent;

(iii) Establishes that the proposed notice is authorized; and

(iv) Acknowledges that the Government has no liability for the disclosure, use, or reproduction of any data made prior to the addition of the notice or resulting from the omission of the notice.

(3) If data has been marked with an incorrect notice, the Contracting Officer may—

(i) Permit correction of the notice at the Contractor’s expense if the Contractor identifies the data and demonstrates that the correct notice is authorized; or

(ii) Correct any incorrect notices.

(g) Protection of limited rights data and restricted computer software.

(1) The Contractor may withhold from delivery qualifying limited rights data or restricted computer software that are not data identified in paragraphs (b)(1)(i), (ii), and (iii) of this clause. As a condition to this withholding, the Contractor shall—

(i) Identify the data being withheld; and

(ii) Furnish form, fit, and function data instead.

(2) Limited rights data that are formatted as a computer database for delivery to the Government shall be treated as limited rights data and not restricted computer software.

(3) [Reserved]

(h) Subcontracting. The Contractor shall obtain from its subcontractors all data and rights therein necessary to fulfill the Contractor’s obligations to the Government under this contract. If a subcontractor refuses to accept terms affording the Government those rights, the Contractor shall promptly notify the Contracting Officer of the refusal and shall not proceed with the subcontract award without authorization in writing from the Contracting Officer.

(i) Relationship to patents or other rights. Nothing contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government.

LABORATORY License Requirements

The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement shall also be included in any subcontract for services under the contract.

Reporting Requirements and Deliverables

Reports and/or deliverables will be tailored for each contract award depending on nature of effort proposed, complexity and the required amount of Government oversight. The following list is an example of reports and their general format that the Government may require. This list is not all inclusive. Offerors will be presented with a list of required reports for a specific effort prior to submitting a final proposal revision and before contract award.

1. Initial Baseline Financial Management Report: The Contractor shall prepare a time-phased baseline initial financial management report, detailing by month how the Contractor plans to incur costs for the total xx-month contract period. The report shall be prepared and submitted in accordance with instructions set forth on the reverse side of the form. The initial baseline financial management report shall be submitted to the CO within 30 business days after the contract effective date.

The total estimated cost and direct labor hours reflected in the baseline report must equal the contract values for the total contract period. The report shall be updated, as required, during the contract performance by submission of revised pages for approval by the Contracting Officer. The baseline financial report shall be revised each time a contract modification is executed which increases or decreases the contract estimated cost, for a reason other than an overrun. The report shall not be revised to include overrun costs.

Minimum reporting categories shall include:

a. Direct Labor Hours

b. Direct Labor Dollars

c. Overhead(s)

d. Subcontract

e. Material

f. Other Direct Cost

g. General and Administrative (G&A)

h. Total Estimated Cost

i. Fixed Fee

j. Total Estimated Cost and Fee

2. Monthly Financial Management Report (FMR): The contractor shall submit a Monthly Financial Management Report. The FMR shall also serve as the Contractor’s invoice. The form shall be prepared and submitted in accordance with the instructions set forth on the reverse side of the form and as further defined below:

a. Due not later than the 10th working day following the close of the Contractor's accounting period being reported.

b. Columns 8.a and b shall be completed using estimates (forecasts) for the succeeding two months.

c. The reporting categories shall be the same as those specified for the Initial Baseline Financial Management Report.

The FMR shall include a narrative explanation for variances exceeding +/- 5 percent between estimated dollars shown in the prior month and actual dollars shown in the current month at the contract level. (For example, the estimated dollars shown for June in column 8a. in the May report and the actual June dollars shown in column 7a. in the June report) Accuracy of financial reporting will be evaluated as part of the annual performance evaluation.

3. Security Plan – This report shall include the negotiated changes developed to protect information from unintended release or compromise and may include software, computer and physical security requirements. Performance of the work under this contract shall be in accordance with this approved Security Plan.

4. Technical Progress Reports (TPR) – The Contractor shall submit technical progress reports monthly. The contractor shall submit the progress reports via e-mail of less than 20 pages in length. Reports shall be in narrative form, informal, and may include additional graphics if needed. The TPR shall contain brief descriptions of what was accomplished since the last reporting, what is planned for the next month, and what are the current or anticipated impediments, technical or otherwise, to accomplishing the planned activities. The TPR is not required in months that an Annual Technical Progress Report or Final Report are required. The general format shall be:

a. A title page containing the heading “Technical Progress Report” that lists the contract number, title, the period of performance being reported, the Contractor's name, address, and other contact information, the author(s), and the date of submission. Include:

b. A brief introduction covering the purpose and scope of the contract effort.

c. A brief description of the progress including work performed, test results, and milestones achieved during the period covered.

d. A brief description of the work proposed for the next reporting period including a summary table of activities or tasks to be accomplished by a certain date and by whom.

e. A brief description of any outstanding problems and issues with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, causes of the differences and, if project activity is delinquent, then what corrective actions were completed, planned or in progress.

f. Manufacturing updates of progress in relation to the Manufacturing plan including attainment of milestones, updates to the product development timeline, lot manufacturing schedules and release dates, and anticipated regulatory inspections and preparation

g. FDA inspections and consultation results.

h. Updated timelines that reflect accurate progress on the schedule/critical path

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

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

k. Attachments – Results or protocols developed on the project must be provided as attachments, preprints/reprints of papers and abstracts.

5. Annual Technical Progress Report (ATPR) – The Contractor shall submit an Annual Technical Progress Report in lieu of a TPR following each anniversary month from the contract effective date. The ATPR shall summarize all of the work completed during the previous year and be suitable for publication. The ATPR shall follow the same format as the TPR with the inclusion of an Executive Summary. An ATPR is not required for the period when the Final Report is required.

6. Study Protocols –Submit all protocols and protocol amendments for approval by the Contracting Officer’s Technical Representative (COTR) prior to submission to the FDA.

7. Final Study Reports – Final Study Reports shall be submitted for non-clinical and clinical studies. The clinical trial reports shall follow the format of International Conference on Harmonization document ICH E3 “Guidelines on Structure and Content of Clinical Study Reports” http://www.fda.gov/CDER/GUIDANCE/iche3.pdf. Draft Final Reports will be submitted to the COTR and CO for review and comment within 30 days of completion of the analysis of the study data. The Contracting Officer shall provide written comments within 30 days after the submission of the Draft Final Report. The comprehensive Final Report will be submitted to the CO and the COTR within 30 days after receiving comments on the Draft Final Report from the CO.

8. FDA Communications and Submissions – Within thirty (30) days of receiving correspondence or meeting with the FDA, submit appropriately formatted electronic copies of the correspondence or meeting minutes/summaries to the COTR.

Within thirty (30) days of an audit related to conformance to FDA regulations and guidance, including adherence to GLP, GMP, or GCP guidelines, the Contractor shall provide copies of the audit report and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report to the COTR.

9. Subcontracting Reports (Ref FAR 52.219-9 APR 2008) - Submit Standard Form 294, Subcontracting Report for Individual Contracts, and Standard Form 295, Summary Subcontractor Report using the Electronic Subcontract Reporting System (eSRS ). Access to eSRS can be found at: http://www.esrs.gov/

10. Federal Contractor Veterans Employment Report -- In compliance with Clause 52.222-37 (SEP 2006), Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans, the Contractor shall submit the Federal Contractor Veterans Employment Reports (VETS-100) as required by this clause.

11. Audit Reports - The Contractor shall provide interim and final audit reports to the COTR and the CO within thirty (30) calendar days of the completion of the audit. BARDA reserves the right to conduct independent audits of the Contractor and its subcontractors as needed to evaluate compliance with the FDA regulations and guidance, including those required to meet GLP, GMP or GCP standards

12. Plan Updates: Any updates or revisions of the plans required by this contract shall be a required deliverable. Plans include but are not limited to the Clinical Development and Regulatory plan, Project and Management plan, Disposition plan, Assay Validation plan, Stability Study plan, Expiration Dating plan, Labeling Plan, Manufacturing plan and Security plan.

13. Final Report – The Contractor shall summarize all of the work done under this contract into a final report suitable for publication as an HHS Contractor Report. The final report may include proprietary information but it must be documented in either a separate Appendix to the final report (which can stand on it’s own without the Appendix) or as a completely separate document. The final report should include tables, graphs, diagrams, curves, sketches, photographs, and drawings in sufficient detail to explain comprehensively the results achieved under the contract. The report shall contain but not be limited to:

a. Executive summary

b. Details of each of the tasks, clinical trials and studies with figures

c. A summary of the progress toward the goals established in the proposal and as modified by the work completed

d. A prioritized suite of enabling technologies with descriptions and roadmaps of the steps needed to achieve the goals of the program

e. The Final Drug (FDP) or Biologic Product’s (FBP) manufacturing history (if applicable) over the life of the contract, compliance requirements (federal, state, and local) and final product specifications including rejection criteria and history

f. Conclusions

g. Any additional research or follow-on activates that may further the science

Evaluation Factors A. Evaluation Criteria:

Proposals will be evaluated based on Technical Capability, Past Performance and Cost Realism/Reasonableness. Technical Capability is comprised of two (2) subfactors, Program Relevance and Overall Scientific and Technical Merits. Technical Capability is significantly more important than Past Performance and when combined, is significantly more important than Cost/Price. Subfactors are relatively equal in importance. Compliance factors may be required in the Full Proposal submission depending on the effort and required laws, regulations and policy. If so, Compliance factors will be identified at time of invitation for Full Proposals and will be evaluated on a Go / No Go basis. Compliance factors must receive a “Go” rating prior to contract award. An example a Compliance factor may be the requirement for a Small Business Plan in accordance with FAR Part 19.

1. Technical Capability

a. Program Relevance (Interest)

1) Innovations in platforms applied to medical countermeasure development that align with the projected near or mid-term objectives identified in the PHEMCE Implementation Plan for CBRN Threats and the National Strategy for Pandemic Influenza (http://www.pandemicflu.gov).

2) Medical countermeasures that focus on diagnosis, post-event prophylaxis, post-exposure treatment/mitigation, and are also effective when administered within the treatment window for that agent.

3) Medical countermeasures that are readily administered during a public health emergency. For instance, oral, self administration is preferred over intra-muscular (i.m.) or subcutaneous (s.c.) injection, and i.m. or s.c. injection is preferred over intravenous administration from a logistical and emergency response perspective. Medical countermeasures whose developmental maturity is commensurate with advanced or applied research.

b. Overall Scientific and Technical Merits

1) The degree of innovation and potential to offer a revolutionary increase in capability or a significant reduction in cost commensurate with the potential risks of the innovative approach.

2) The soundness, feasibility, and validity of the proposed plans, methods, techniques, and procedures of the technical proposal.

3) The Offeror’s understanding of the scope and the technical effort needed to address it.

4) The reasonableness of the proposed schedule.

5) The Offeror’s understanding of the statutory and regulatory requirements for FDA licensure (if applicable).

6) The expertise of technical personnel proposed.

2. Past Performance: The Offeror’s capabilities, related experience, and past performance, including the qualifications, capabilities, and experiences of the proposed key personnel.

a. The Offeror’s experience in relevant efforts with similar resources.

b. The ability to manage the proposed effort.

3. Cost Realism and Reasonableness. Each price / cost response will be reviewed for price / cost realism and reasonableness. The technical approach provided by the Offeror serves as a rationale for the labor mix and labor hours used.

B. Evaluation Techniques.

Selection decisions will be made following peer and/or scientific review of the proposals. Several evaluation techniques are regularly used within BARDA. In all cases proposals are subject to scientific review by disciplined specialists/doctors in the area of the proposal. Some proposals are reviewed entirely in-house, others are evaluated by a combination of in-house and selected external reviewers, while yet others are subject to the full external peer review technique (with due regard for conflict-of-interest and protection of proposal information), such as through assembled panels. The final decisions are made by a BARDA selecting official. A proposal which is scientifically and programmatically meritorious, but not selected for award during its initial review may be included in subsequent reviews unless the Offeror requests otherwise.

C. Evaluation Ratings

Technical Capability and Past Performance will be rated using adjectival ratings and documenting the strengths and weaknesses in accordance with the evaluation criteria. Adjectival ratings and definitions are as follows:

Proposals will be categorized as follows:

CAT I Well conceived, scientifically, and technically sound proposals important to program goals and objectives. Proposals in Category I are priority for award subject to funds availability.

CAT II Scientifically and technically sound proposals important to program goals and objectives however require further development. These offers may be selected for award subject to funds availability. CAT II proposals are at a lower priority than CAT I

CAT III Proposals not technically sound or do not meet program goals and objectives. CAT III proposals will not be further considered for award.

Offerors selected for negotiations may be subject to inspections of their facilities and Quality Assurance/Quality Control (QA/QC) capabilities. The decision to inspect specific facilities will be made by the COTR in coordination with the CO.