BAA-NIAID-DMID-NIH-AI-2015037.pdf

Broad Agency Announcement No. BAA-NIAID-DMID-NIH-AI-2015037

Title: DEVELOPMENT OF THERAPEUTIC PRODUCTS FOR BIODEFENSE AND

EMERGING INFECTIOUS DISEASES

Issue Date: July 14, 2015

Due Date: August 31, 2015

Issuing Office: Office of Acquisitions, Division of Microbiology and Infectious Diseases, DEA, NIAID, NIH, 5601 Fishers Lane, Room 3D39, Rockville, MD 20852

Contracting Officer: George W. Kennedy

Contact Point/Contract Specialist: Alexandra J. Buck

Set-Aside: No

It is requested that you send an early electronic mail message to the Contract Specialist if you intend to respond to this BAA. In your message please indicate the name of the organization, address, telephone, and include the name of the Principal Investigator (“PI”), plus a short description of the scientific fields encompassed by the response.

I. INTRODUCTION

You are invited to submit a proposal in accordance with the requirements of this BROAD AGENCY ANNOUNCEMENT (BAA). The BAA is governed by Federal Acquisition Regulation (FAR) 6.102 and FAR 35.016, as well as the NIH Policy Manual, Manual Chapter 6035, Broad Agency Announcements. A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and by addressing the part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature identifying areas of research interest and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.

Offers submitted in response to this BAA must present detailed technical and business proposals designed to meet the Research and Technical Objectives described herein. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Offeror, not the Government.

Since they are not submitted in accordance with a common SOW issued by the Government, proposals are NOT evaluated against each other. Instead, Research and Technical Objectives are provided in the BAA that describes the research areas in which the Government is interested. Proposals received in response to the BAA will be evaluated in accordance with Evaluation Factors for Award specified in Section VIII of this document.

Multiple awards are anticipated. The amount of resources made available under this BAA will depend on the quality of the proposals received and the availability of funds. The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this BAA, and to make awards without discussions with Offerors. The Government also reserves the right to conduct discussions, if it is later determined to be necessary.

Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award.

In the event NIAID desires to award only portions of a proposal, negotiations may be opened with that Offeror. The Government reserves the right to fund proposals in phases with options for continued work at the end of one or more of the phases.

NIAID estimates that two or more awards may be issued for a total cost (direct and indirect costs combined) of up to $15.3 million in Fiscal Year 2016 for all awards during the first non-severable phase.

Awards are expected to be made on or about June 1, 2016. It is anticipated that the total costs for each award may vary depending upon the scope and capacity of the technical objectives of the award. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The total period of performance comprised of a base period and options proposed by an Offeror should not exceed five (5) years.

II. BACKGROUND AND TECHNICAL OBJECTIVES

A. BACKGROUND

Research supported and conducted by NIAID, National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, with the exception of the human immunodeficiency virus (HIV). This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. NIAID also has a mission to advance the development of new medical countermeasures (MCM) against the biological agents that are most likely to be used in a terror attack on civilian populations as well as emerging and re-emerging infectious diseases such as MERS, Ebola Virus Disease, antibiotic resistant bacterial infections and pandemic influenza.

NIAID has been conducting and supporting much of the research and development for biodefense, targeting multiple pathogens, including NIAID Category A, B, and C priority pathogens (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Pages/CatA.aspx).

This solicitation aims to further advance the translation of promising therapeutic products against priority pathogens and emerging infectious diseases.

These efforts are guided by the current NIAID Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/strategicplan.aspx), which established a strategy for developing new and improved medical countermeasures against a broad array of emerging and re-emerging infectious diseases including NIAID Category A, B and C Priority Pathogens. NIAID’s plan reflects the Institute’s partnerships with the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and Department of Homeland Security. The HHS PHEMCE coordinates interagency efforts aiming to optimize our preparedness for public health emergencies with respect to the creation, stockpiling, and use of medical countermeasures. Led by the Assistant Secretary for Preparedness and Response (ASPR), HHS, PHEMCE consists of the NIH, Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC), and senior leadership from other federal agencies. The PHEMCE Implementation Plan (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) describes the current priorities for medical countermeasure development against advanced, enhanced, or emerging threats.

Furthermore, an Executive Order released by the President of the United States in 2014 (http://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria) and the related National Strategy to Combat Antibiotic- Resistant Bacteria (http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf) highlight one of the most urgent public health threats facing us today – antibiotic resistance – and encourage the development of new and next-generation antibiotics, among other goals.

The goals of this solicitation also reflect the intent of this new guidance.

B. TECHNICAL OBJECTIVES

The objective of this solicitation is the development of therapeutic products for use in post-event settings following the intentional release of a NIAID Category A, B, or C Priority Pathogen or in response to naturally occurring outbreaks of infectious diseases caused by the NIAID Category A, B, and C Priority Pathogens. Only agents identified as NIAID Category A, B and C Priority Pathogens are eligible as proposed candidates/products for this solicitation.

Organizations responding to this BAA must have documented expertise in drug discovery and development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against biological threats identified as NIAID Category A, B and C Priority Pathogens or 2012 HHS PHEMCE Strategy and Implementation Plan (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) and shall complete and submit the Summary of Related Activities form from the following website:

h t t p : / / o a m p . o d . n i h . g o v / s i t e s / d e f a u l t / f i l e s / D G S / c o n t r a c t i n g -f o r m s / s u m m a r y - r e l a t e d - a c t i v i t i e s . p d f .

This BAA solicitation focuses on the development of promising lead therapeutic candidates/products. For the purposes of this BAA, a lead candidate has demonstrated feasibility of manufacturing, in vitro and in vivo evidence of efficacy, and sufficient characterization to allow the development of a draft target product profile.

One category of products being solicited are those with broad spectrum therapeutic activity against viruses or bacterial pathogens. This solicitation also focuses on supporting development of promising anti-toxins as therapeutic candidates/products, particularly small molecule therapeutics with anti-toxin activity. The research and development activities supported through this BAA will allow candidate therapeutic countermeasures to progress through the product development pipeline toward licensure by the FDA.

Broad spectrum activity is a characteristic that enables a particular product to mitigate biological threats across a range or class of agents. There are a number of traditional threats for which effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered antibacterial and antiviral resistance. A limited number of anti-infectives with broad spectrum activity directed at common, invariable, and essential components of different classes of microbes, or directed at host functions that are required by different classes of microbes, could potentially be effective against both traditional and non-traditional threats. This approach would allow a small number of drugs to replace dozens of pathogen-specific drugs for emergency use.

Additionally, strategies to overcome bacterial and viral drug resistance could extend the clinical utility of existing broad spectrum anti-infectives and have immediate benefits.

Moreover, broad spectrum treatments directed towards host targets have the potential to be effective against one or more diseases. For these reasons, proposals on the non-traditional therapeutics are encouraged provided they have demonstrated therapeutic activity when used alone or in combination with an existing licensed product. Therapeutic activity is defined as the cure or mitigation of disease once signs and symptoms of infection are evident.

For the purposes of this BAA, the ideal broad spectrum therapeutic candidate is defined as a single agent that meets all three of the following criteria:

1) A drug (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins) intended for use in the cure, mitigation, or treatment of two or more bacterial or viral pathogens; AND

2) An agent with demonstrated in vivo activity in an appropriate therapeutic model of disease; AND

3) An agent that will complete evaluation in a Phase 1 clinical trial within the 5-year proposed period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports E3 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E3/E3_Guideline.pdf).

Toxins are poisonous substances produced by living cells or organisms that are capable of causing or exacerbating disease when introduced into the body tissues. While bacteria that produce toxins may often be eliminated by the use of antibiotics during an infection, disease may still occur or may progress because of the presence of toxins produced by the pathogen.

In addition, toxins may be isolated and themselves be introduced into body tissues and thereby cause disease and death, as in the case of ricin. Treatments are needed to target specific toxins in order to cure or mitigate disease caused by those toxins.

For the purposes of this BAA, the ideal anti-toxin therapeutic candidate is a single agent, preferably a small molecule, meeting the following criteria/definitions:

1) An agent intended for use in the cure, mitigation or treatment of intoxication; AND

2) An agent that has demonstrated activity against a specific toxin in an in vivo model of disease; AND

3) An agent that will complete evaluation in a Phase 1 clinical trial within the 5-year proposed period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports E3 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E 3_Guideline.pdf).

Therapeutics targeted under this BAA are specified as the following:

Broad spectrum anti-bacterial:

Therapeutic with activity against one of the following bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B.

mallei AND in addition, activity against one other NIAID Category A, B or C bacterial threat agent.

Antibacterial therapeutic with activity against two or more of the urgent, serious, and concerning drug-resistant bacterial threats listed in the 2013 CDC Antibiotic Resistance Threats in the United States report (http://www.cdc.gov/drugresistance/biggest_threats.html).

Broad spectrum anti-viral:

Therapeutic with activity against one of the following viral pathogens: Ebola virus, Marburg virus, Orthopox viruses representative of Variola major, Dengue virus, MERS- CoV, Chikungunya virus AND, in addition, activity against one other NIAID Category A, B or C viral threat agent including activity against discrete strains, species or serotypes within a virus genus.

Therapeutic active against multiple influenza subtypes directed at either viral or host targets.

Anti-toxins:

A therapeutic agent, preferably a small molecule, with activity against one of the following toxins: Botulinum neurotoxin, Staphylococcus enterotoxin B, Bacillus anthracis Protective Antigen, Lethal Factor or Edema Factor, and ricin toxin.

Contracts awarded under this BAA will not target:

Basic research and discovery of new candidates/products Refinement of a lead series to identify a candidate Development of devices, topical products, prophylactic products, or diagnostics Development of candidates/products that have not demonstrated therapeutic activity in a relevant animal model of disease Development of serum-derived products Development of licensed products as new formulations or for additional clinical indications

III. GENERAL PROPOSAL INSTRUCTIONS AND INFORMATION

Separation of Technical and Business Proposals

The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the Offeror's understanding of the project may be evaluated. The Technical Proposal should disclose the technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions and total cost for the work (see http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost- Summ.pdf).

However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions.

Proposals should be direct and concise in presenting information which clearly describes the proposed project. Offerors should realize that a concise and well formulated proposal is usually more effective to communicate project ideas to reviewers versus a voluminous proposal that lacks effective distillation of ideas.

A. PROPOSAL SUBMISSION

1. Receipt Date

The deadline for receipt of proposals submitted in response to this announcement is:

August 31, 2015 at 5:00 P.M. Eastern Time

B. ONLINE SUBMISSION OF ELECTRONIC PROPOSALS

1. eCPS PROPOSAL SUBMISSION PROCESS:

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

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

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

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

2. Creating and Naming Files:

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

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

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

1. The first file must be a PDF of your Business Proposal, with all attachments, including the Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned and merged into the Business Proposal PDF file.

2. The remaining file(s) should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

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

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

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

3. Formatting and Page Limitations:

a. Formatting for proposals:

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

2. Font size must be 10 to 12 points.

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

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

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

b. Page limitations:

1. The Technical Proposal shall not exceed 100 pages, exclusive of appendices and letters signed by the appropriate authority allowing for pre-award site visits. Although no page limit has been placed on the Business Proposal, Offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

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

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

C. NAICS Code and Size Standard

Note: The following information is to be used by the Offeror in preparing its Representations and Certifications, specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATION, FAR Clause 52.219-1.

(1) The North American Industry Classification System (NAICS) code for this acquisition is

541712.

(2) The small business size standard is 500 employees.

THIS REQUIREMENT IS NOT SET ASIDE FOR SMALL BUSINESS. However, the Federal Acquisition Regulation (FAR) requires in every solicitation, (except for foreign acquisitions) the inclusion of the North American Industry Classification System (NAICS) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.

D. Restriction on disclosure and use of data

(1) The proposal submitted in response to this request may contain data (trade secrets;

business data (e.g., commercial information, financial information, cost and pricing data);

and technical data) which the Offeror, including its prospective subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted; provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, as amended, and the Offeror marks the cover sheet of the proposal with the following statements, specifying the particular portions of the proposal which are to be restricted:

"Unless disclosure is required by the Freedom of Information Act, 5 U.S.C. 552, as amended, (the Act) as determined by Freedom of Information (FOI) officials of the

Department of Health and Human Services (HHS), data contained in the portions of this proposal which the Offeror has specifically identified by page number, paragraph, etc. as containing restricted information shall not be used or disclosed except for evaluation purposes.

The Offeror acknowledges that HHS may not be able to withhold a record (e.g. data, document, etc.) nor deny access to a record requested pursuant to the Act and that the HHS's FOI officials must make that determination. The Offeror hereby agrees that the Government is not liable for disclosure if HHS has determined that disclosure is required by the Act.

If a contract is awarded to the Offeror as a result of, or in connection with, the submission of this proposal, the Government shall have right to use or disclose the data to the extent provided in the contract. Proposals not resulting in a contract remain subject to the Act.

The Offeror also agrees that the Government is not liable for disclosure or use of unmarked data and may use or disclose the data for any purpose, including the release of the information pursuant to requests under the Act.

(2) In addition, the Offeror must mark each page of data it wishes to restrict with the following statement: "Use or disclosure of data contained on this page is subject to the restriction on the cover sheet of this proposal or quotation."

(3) Offerors are cautioned that proposals submitted with restrictive statements or statements differing in substance from those cited above may not be considered for award. The Government reserves the right to reject any proposal submitted with a nonconforming statement(s).

E. Communications Prior to Contract Award

Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited at the beginning of this announcement. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

F. Release of Information

Contract selection and award information will be disclosed to Offerors in accordance with regulations applicable to negotiated acquisition. Prompt written notice will be given to unsuccessful Offerors as they are eliminated from the competition, and to all Offerors following award.

G. Preparation Costs

This BAA does not commit the Government to pay for the preparation and submission of a proposal.

H. Promoting Efficient Spending

On September 21, 2011, the Office of Management and Budget issued Memorandum M-

11-35 , entitled, "Eliminating Conference Spending and Promoting Efficiency in Government," emphasizing the President's priority to ensure that the Government operates with the utmost efficiency and eliminates unnecessary or wasteful spending.

This was followed by the Executive Order on Delivering an Efficient, Effective, and Accountable Government ( EO 13576 ) and the Executive Order on Promoting Efficient Spending ( EO 13589 ). On January 3, 2012, the Department of Health and Human Services (DHHS) issued the memorandum "HHS Policy on Promoting Efficient Spending:

Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items, and Printing, and Publications" (See http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html ).

In support of these directives, the NIH issued a January 30, 2012, Memorandum, entitled, "NIH Guidance Related to the HHS Policies on Promoting Efficient Spending: Use of Appropriated Funds for Conferences, Conference Grants and Meetings, Food, Promotional Items, and Printing and Publications." (See http://oamp.od.nih.gov/ )

Any contract awarded as a result of this solicitation will o Specifically prohibit the use of contract funds for the provision of food for meals, light refreshments and beverages for any NIH funded meeting or conference; and o Limit the procurement of meeting space, promotional items, printing and publications

I. Service of Protest (September 2006) - FAR 52.233-2

(1) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

George W. Kennedy, J.D.

Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases DEA, Office of Acquisitions 5601 Fishers Lane, Room 3D39, MSC 9821 Rockville, Maryland 20892-9821

(2) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

J. Institutional Responsibility Regarding Conflicting Interests of Investigators

45 CFR Part 94 promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research to be performed under NIH contracts will be biased by any conflicting financial interest of an Investigator. The Institution shall comply with all requirements of 45 CFR Part 94 at http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=c868ce44081bdf3d09de55d230c9b5b7&r=PART&n=45y1.0.1.

1.51#45:1.0.1.1.51.0.19.4

K. Privacy Act

The contract will require the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform;

and (b) specifies the disposition to be made of such records upon completion of contract performance.

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at:

http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html .

L. Limitations on Use of Appropriated Funds

The Department of Health and Human Services Appropriation Act limits the use of appropriated funds on NIH grant, cooperative agreement, and contract awards as specified below. It is anticipated that these statutory provisions will continue in subsequent fiscal years and be incorporated into any award documents. If selected for negotiations, you will be provided all specific limitations concerning appropriated funds applicable at the time of negotiations.

1) Salary Rate Limitation in Fiscal Year 2015

Offerors are advised that pursuant to P.L. 113-235, signed into law on December 30, 2014, no NIH Fiscal Year 2015 (until September 30, 2015) funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Contractor.

This does not preclude the Offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The salary rate limitation set by P.L 113-235 applies only to Fiscal Year 2015 funds, however, salary rate ceilings for subsequent years may be included in future DHHS appropriation acts. Multi-year contracts awarded pursuant to this solicitation may be subject to unilateral modifications by the Government if an individual's annual salary exceeds any salary rate ceiling established in future appropriations acts. The Executive Schedule, Level II* annual salary rate limitation also applies to individuals proposed under subcontracts, however it does not apply to consultants. P.L. 113-235 states:

"None of the funds appropriated in this title shall be used to pay the salary of an individual through a grant or other extramural mechanism, at a rate in excess of Executive Level II."

LINK TO EXECUTIVE SCHEDULE RATES OF PAY:

http://www.opm.gov/oca/ (For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

*Note to Offerors: The current Fiscal Year Executive Level II Salary Rate shall be adhered to in the preparation of your proposal. All costs associated with any resultant contract award shall be in compliance with the current Fiscal Year Executive Level II Salary rates.

2) Needle Distribution

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

3) Restriction on Abortions

The Contractor shall not use contract funds for any abortion.

4) Continued Ban on Funding of Human Embryo Research

(a) The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).” The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

5) Limitation on Use of Funds for Promotion of Legalization of Controlled Substances

"(a) None of the funds made available in this Act may be used for any activity that promotes the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established by section 202 of the Controlled Substances Act except for normal and recognized executive-congressional communications. (b) The limitation in subsection (a) shall not apply when there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage."

6) Dissemination of False or Deliberately Misleading Scientific

Information

“None of the funds made available in this Act may be used to disseminate scientific information that is deliberately false or misleading.”

7) NIH Public Access Requirement

“The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication:

Provided, that the NIH shall implement the policy in a manner consistent with copyright law.”

Further information on the implementation of NIH’s Public Access Requirement is available in NIH Guide Notice NOT-OD-08-033 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) published on January 11, 2008.

8) Restriction on Pornography on Computer Networks

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

9) Gun Control

The Contractor shall not use contract funds in whole or part, to advocate or promote gun control.

IV. UNIFORM ASSUMPTIONS

For the purposes of estimating costs and preparing the technical proposal, the following POST-AWARD requirements will apply to all awards made under this

BAA.

Offerors are instructed to address responsibility for complying with these requirements in the proposed Statement of Work for the Technical Proposal. Offerors are NOT required to submit documentation to address these post-award requirements in their technical proposals. Instructions for submitting documentation associated with post-award requirements will be provided during negotiations.

A. Audits: Assume three (3) independent QA audits per year for the duration of the contract period of performance.

B. Purchase of Equipment: Cost will NOT be allowed for the purchase of any equipment, hardware, or software under this contract.

C. Alterations and Renovations: Cost will NOT be allowed for any facility construction, alterations, or renovations under this contract.

D. Programmatic Presentations and Meetings

In performance of the work, Offerors are expected to attend the following meetings.

1. Post Award Contract Initiation Meeting

In preparing the proposal, Offerors should include costs for attendance at one Post Award Contract Initiation Meeting. The Contractor will be responsible for arranging a one-day meeting at or near Washington, D.C. or at the contractor site and attendance should include all Key Personnel and all Key Subcontractor personnel.

2. Annual Contract Review Meetings

In preparing the proposal, Offerors should include costs for annual contract review meetings. These meeting are anticipated to be held at the Contractor’s facility and a location at or near Washington D.C. on an alternating-year basis. The meetings are anticipated to be one-day meetings. Offerors should include costs for the attendance of the Key Personnel, members of the External Advisory Group, and Key Subcontractor personnel.

A report of the Post Award Contract Initiation Meeting and Annual Contract Review Meetings shall be prepared by the Contractor and submitted within twenty-one

(21) calendar days following the date of the meetings. These reports shall include the slide presentations and all other meeting materials as well as summaries of all discussions. Minutes of regular, as well as ad hoc teleconferences and meetings shall be provided by the Contractor within two (2) business days following the date of the teleconference or meeting.

3. External Advisory Group Meetings

After contract award and in consultation with the Contracting Officer Representative (COR) and the Contracting Officer, the Contractor will establish an External Advisory Group with the relevant expertise to critically evaluate technical progress in achieving product development objectives and established timelines. It is anticipated that the External Advisory Group will consist of approximately 3-5 members. The membership of the External Advisory Group will be proposed by the Contractor and approved by the COR and Contracting Officer post-award. The specific roles and duties of the External Advisory Group members will be defined by the Contractor and approved by the COR. Compensation for this role will be provided by the Contractor with contract funds as approved by the Contracting

Officer and will be commensurate with the specific roles and duties assigned to the members. The Contractor shall have the External Advisory Group consulting agreements in place within six months of the effective date of the contract.

Reports of all meetings and communications with the External Advisory Group or its individual members will be documented and submitted to the COR and Contracting Officer. Documentation of such meetings/communications will be provided within twenty-one (21) calendar days and will include a summary of the discussions and copies of slide presentations.

NOTE: DO NOT identify or propose External Advisory Group members in the technical or business proposal. Do not contact specific individuals regarding service on the External Advisory Group in advance of contract award.

V. REPORTING REQUIREMENTS AND DELIVERABLES

Reporting Requirements

In performance of the work, the following reporting requirements should be assumed:

A. Monthly Progress Report

This report shall include a description of the technical activities and results during the reporting period and the activities planned for the ensuing reporting period, and shall include a budget summary for costs incurred during the monthly reporting period for the base period and each option and milestone. The funding level will be presented in correlation with percent completion of the activities under the base, option and/or milestone. Monthly Progress Report will not be required when Annual Progress Report is due.

B. Annual Progress Report

This report includes a summation of the technical activities and results for the entire contract period covered, and shall include a description of the technical activities and results during the reporting period, a budget summary for costs incurred during the annual reporting period for the base period and each option and milestone. The funding level will be presented in correlation with percent completion of the activities under the base, option and/or milestone. An Annual Progress Report will not be required for the period when the Final Report is due.

C. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001, applies. Include a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender and race/ethnicity.

D. Final and Draft Reports

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. An annual report will not be required for the period when the Final Report is due. The Contractor shall submit, with the Final Report, a summary (not to exceed 250 words) of salient results achieved during the performance of the contract.

E. Product Development Plan and Work Plan

The Contractor shall update the Product Development Plan and the Work Plan to incorporate the progress from the effective date of the contract. The Contractor shall submit an updated Product Development Plan (PDP) for review within thirty

(30) calendar days of the effective date of the contract and prior to initiation of product development activities, unless otherwise negotiated with the Contracting Officer Representative (COR) and the Contracting Officer. This updated Product Development Plan and Work Plan shall include:

1. Clearly defined goals, product development stages and product development activities.

2. A breakdown of activities by fiscal year and nonseverable stages, Go/No Go decision gates.

3. Quantitative and qualitative criteria and associated data elements for assessing the scientific merit and feasibility of moving to the next stage of product development.

4. A detailed timeline for each stage covering the initiation, conduct and completion of product development activities and a task-linked budget linked (a budget linked to each major activity). A Gantt chart should be provided to outline the proposed activities.

5. The Work Plan shall include a description of the studies to be performed within each stage of the project. The Contractor shall also be required to submit a revised Product Development Plan and associated Work Plan when a change to the approved plans is requested.

6. Risk mitigation strategies for accomplishing the objectives of the contract within the period of performance particularly with respect to adverse experimental or production results, new scientific findings or regulatory guidance from FDA.

NOTE: for purposes of this BAA:

The Product Development Plan describes the critical path and for the proposed candidate/product toward eventual licensure and identifies the decision points/gates for progress of the candidate/product.

The Work Plan describes the studies to be performed at each stage of the project within the 5 year term of award in order to implement the Product Development Plan and advance the product through Phase 1 testing.

F. Milestone Completion/Decision Gate Report

A Decision Gate Report shall be submitted when the Contractor has completed a stage of product development and has reached a Go/No Go decision point, as defined in the Work Plan for the Implementation of the Staged Product Development Plan. These reports shall be in sufficient detail to explain comprehensively the results achieved. The description shall also include pertinent data and/or conclusions resulting from the analysis and scientific evaluation of data accumulated to date under the project. Offerors should propose the timing of these reports to coincide with the decision points specified in their SOW.

Note: Contract activities will be divided into manageable time frames with associated deliverables. Initial funding will be for the Base Period only.

Funding of subsequent deliverables will be funded by Options. Each Option will be fully funded when exercised and will be dependent on successful completion of critical Milestones, including the United States Government acceptance of associated deliverables when applicable. The critical predecessor activities should constitute Go/No Go criteria for successor activities. The contract budget will be aligned with the Base Period, Options and associated tasks identified in the Product Development Plan and associated Gantt chart.

G. Audit Reports

Within thirty (30) calendar days of completion 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.

H. Draft and Final Clinical Trial Protocols

NIAID has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in the NIAID-funded clinical trials. Therefore, as described in the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), the Contractor shall develop a protocol for each clinical trial and submit draft protocols for review and all final protocols and protocol amendments for approval by the COR. Prior to FDA submission and enrollment, an additional review and approval period may be required for changes in the final protocol. Three (3) weeks should be planned for each review period. It is recommended that protocols be submitted using the approved DMID template and include a sample Informed Consent and Clinical Trials Monitoring Plan. The DMID templates and other important information regarding performing human subject research are available at http://www3.niaid.nih.gov/research/resources/DMIDClinRsrch.

I. Draft and Final Clinical Study Report

For each clinical study performed with contract support, a Draft Clinical Study Report shall be provided within thirty (30) calendar days of the completion of the analysis of all data generated in the clinical trial. Final Clinical Study Reports shall follow the ICH guidelines on Structure and Content of Clinical Study Reports E3 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E3/E3_Guideline.pdf).

J. Draft and Final Non-Clinical Study Protocols

Provide electronic copies of protocols for all non-clinical studies for review and approval to the COR at least 10 calendar days before review and finalization of the protocol unless otherwise agreed upon by the COR. The non-clinical study protocols are expected to undergo at least one round of revision and resubmission for final approval.

K. Draft and Final Animal Efficacy Reports

For each animal efficacy study performed with contract support, a Draft Animal Efficacy Study Report should be prepared within thirty (30) calendar days, unless otherwise approved by the COR, of the completion of the analysis of all data and submitted to COR for review. A Final Animal Efficacy Study Report shall be submitted to the COR within thirty (30) calendar days of finalization of the report after the draft reports have been reviewed. At least one round of revision and resubmission for final approval is to be expected. The Animal Efficacy Study Reports shall include a complete description of the experimental design, protocol, methods, reagents, data analysis, and conclusions of studies performed to demonstrate efficacy of therapeutic product for the indication (i.e., post-exposure prophylaxis or treatment) being sought.

L. Copies of FDA Correspondence and Meeting Summaries

Submit electronic copies of the correspondence or meeting within seven (7) calendar days of receiving correspondence from or holding a meeting with the FDA.

M. Human Subject IRB Annual Report (Form OMB No. 0990-0263)

Within thirty (30) calendar days of each anniversary date of the effective contract award, submit Human Subject Annual Report.

N. Invention Reporting

Electronic reporting of inventions shall be required as well as paper copies.

O. Samples of Products

The Contractor shall submit samples of non-GMP candidate therapeutics and GMP material manufactured with contract funding. The type of material and the amount will be specified in the contract.

P. Technology Transfer

Technology Transfer packages shall include complete protocols and critical, assays or procedures developed and/or improved with contract funding.

Q. Institutional Biosafety Approval

The Contractor shall provide documentation of materials submitted for Institutional Biosafety Committee Review and documentation of approval of experiments.

R. Other Reports

Copies of other reports for work generated under the…