TTDRB_OA_Final_BAA.pdf

Broad Agency Announcement

No. NIH-AI-2014007

Title: Targeting Therapeutics Development to Relieve Bottlenecks:

Optimizing Lead Therapeutic Compounds against Infectious Pathogens

Issue Date: 06/13/2014

Due Date: 08/13/2014

Issuing Office: Office of Acquisitions, Division of Microbiology and Infectious Diseases, DEA, NIAID, NIH, 6700-B Rockledge Drive, room 3214, MSC 7612, Bethesda, Maryland 20892-7612

Contact Point/ Contracting Officer: Mr. Sevag Kasparian

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, 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 that 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 the National Institute of Allergy and Infectious Diseases (NIAID) decides 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 three to five contracts may be issued for a total cost (direct and indirect costs combined) of up to $ 4 million in Fiscal Year 2015 for all awards during the first non-severable phase. Awards are expected to be made on or about 08/13/2015. 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 three (3) 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. The 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.

The current NIAID Strategic Plan for Biodefense Research (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/biosp2007.pdf) establishes a strategy for developing new and improved medical countermeasures against a broad array of emerging and re-emerging infectious diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx), which includes NIAID Category A-C Priority Pathogens. The 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 Response (ASPR), HHS, PHEMCE consists of the NIH, Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC), along with ex officio participation from other federal agencies.

The PHEMCE Implementation Plan for Threats Chemical, Biological, Radiological, and

Nuclear (CBRN) (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) sets the current priorities for medical countermeasure development against advanced, enhanced, and emerging threats and advanced agents.

In August 2012 the NIAID held a workshop entitled “Bridging the Gap: Overcoming Bottlenecks in the Development of Therapeutics for Infectious Diseases” This workshop brought together product development experts from industry, government, academia and the non-profit sector to identify and clarify challenges in the development of therapeutics for infectious diseases. One of the areas highlighted by participants was the importance of medicinal chemistry in early drug development, and the need to integrate chemistry and biology as well as computational and structural biology in early drug development. This solicitation is intended to help address this need. The full report from the workshop can be found at:

http://www.niaid.nih.gov/about/organization/dmid/bottlenecks/Pages/summary.aspx

B. Technical Objectives

The primary objective of this BAA is to support the advancement of promising lead therapeutics to the clinical drug candidate stage for the treatment of emerging infectious and biodefense diseases as listed in NIAID Category A, B and C Priority Pathogens (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx).

Only candidate products against NIAID Category A, B and C Priority Pathogens are eligible under this solicitation.

Activities supported under this BAA include medicinal chemistry and preclinical in vitro and in vivo testing of a lead compound series in order to produce profiles of their efficacy, synthetic feasibility, stability, and toxicity, which will be used to identify a novel small molecule drug candidate for future clinical development. Of particular interest are broad-spectrum anti-virals, and broad-spectrum anti-bacterials.

For the purposes of this BAA, the ideal lead compound for development is defined as a small molecule with demonstrated activity in appropriate in vitro assays or in vivo models against one or more selected bacterial or viral pathogens. The lead compound should have a demonstrated path in the synthesis of derivatives at multiple sites on its core molecular scaffold. A lead compound is more advanced in development than hit compounds and lead candidates. Hit compounds are potent modulators that are identified via in vitro or in vivo screening. Lead candidates are selected among the hit compounds for further evaluation.

This evaluation may include determination of the activity, selectivity, ADMET properties as well as chemical synthesis of derivatives in order to develop a structure-activity relationship.

A lead compound is selected among the lead candidates and their derivatives, and a lead compound typically exhibits the best panel of activity, selectivity, ADMET properties and chemical feasibility. Further in vitro and in vivo testing of a lead compound may be performed in order to verify its selection.

Contracts awarded under this BAA will support:

Chemical synthesis of analogs to develop structure-activity relationship profiles Chemical optimization of core molecular scaffolds to improve physiochemical properties to produce more drug-like molecules Synthetic route-scouting towards process development Formulation studies to optimize dosing, pharmacodynamics, product stability and other drug properties In vitro and non-GLP in vivo testing for toxicity, activity, ADME (absorption, distribution, metabolism, and excretion) properties Preclinical non-GLP efficacy testing for biodefense and emerging infectious diseases

Contracts awarded under this BAA will not support:

Screening of compound libraries or compound series for hit identification Development of devices, prophylactic products or diagnostics Development of biopharmaceutical products Development of animal infectious and/or efficacy models Compounds intended to be administered solely as aerosols Manufacturing, characterization and release of cGMP material Conduct of Investigational New Drug (IND)-enabling non-clinical studies Development, submission, and sponsorship of an Investigational New Drug (IND) Clinical studies in humans

Lead compounds with broad spectrum activity are encouraged. Broad spectrum activity is defined as 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 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 use in a biothreat emergency. 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, host receptors, and cellular processes can directly prevent or treat diseases. These approaches could provide clinical utility when used alone or in combination with conventional anti-infectives.

Broad spectrum therapeutics supported under this BAA are specified as the following:

• Broad spectrum anti-bacterial: Therapeutic with activity against more than one of the NIAID Category A, B and C bacterial threat agent AND including activity against at least one of the following bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazeki.

• Broad spectrum anti-viral: Therapeutic with activity against more than one of the NIAID Category A, B and C viral threat agent AND including activity against at least one of the following viral pathogens: Ebola virus, Marburg virus, Variola major, Dengue virus, Chikungunya virus and human influenza virus.

• Host-directed broad spectrum therapeutic: Therapeutic directed at a host response thereby reducing morbidity and mortality from exposure/infection and is effective against more than one of the NIAID Category A, B and C bacterial or viral threat AND including at least one of the following bacterial and viral pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B.

mallei, Rickettsia prowazeki, Ebola virus, Marburg virus, Variola major, Dengue virus, Chikungunya virus and human influenza virus.

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 (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx) 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 (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf)

III. GENERAL PROPOSAL INSTRUCTIONS AND INFORMATION

A. Proposals must be in TWO parts

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 should disclose your 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). 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.

B. Proposal Submission

1. Receipt Date

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

08/13/2014, 3:30 PM EST

2. Proposal Submission

a. The National Institute of Allergy and Infectious Diseases (NIAID) currently requires proposals to be submitted via two methods:

1) Disc (CD or DVD)

2) Online

Notes:

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

Disc and online proposals must be exactly the same.

3. DISCS (i.e., CD or DVD)

a. Delivery Instructions

If Hand Delivery or Express Service If using U.S. Postal Service

Mr. Sevag Kasparian Contracting Officer Office of Acquisitions, DEA, NIAID, NIH 6700B Rockledge Drive, Room 3212, Mr. Sevag Kasparian Contracting Officer Office of Acquisitions, DEA, NIAID, NIH 6700B Rockledge Drive, Room 3212, MSC

MSC 7612

Bethesda, Maryland 20817

Bethesda, Maryland 20892-7612

1) Mark each package with the following items:

The solicitation number: BAA-NIAID-DMID-NIH-AI-2014007

“TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY”

2) All material sent to this office by courier should be sent to the Hand Delivery or Express Service address.

3) The U.S. Postal Service's "Express Mail" does not deliver to the hand delivered (20817 zip code) address. Any package sent to this address via this service will be held at a local post office for pick-up. The Government is not responsible for picking up any mail at a local post office.

4) 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.

b. Discs – Creating and Naming Files:

1) 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.

2) The Business Proposal must be comprised of the following two files:

a) 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” (see 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.

b) The remaining file(s) must 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.

3) A separate Disc must be submitted for the Technical Proposal and Business Proposal. Offerors who submit both Technical and Business Proposals on the same Disc will be required to resubmit the proposals on separate Discs.

4) 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.

5) 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 BAA number, the type of proposal, and the date of the proposal, (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2014007_Technical_Date.pdf Business Proposal: XYZ Company_NIHAI2014007_Business_Date.pdf Excel Workbook: XYZ Company_NIHAI2014007_Business_Date.xlsx

4. Online Submission of Electronic Proposals

a. eCPS PROPOSAL SUBMISSION PROCESS

1) In addition to discs, offerors are required to submit an electronic copy of proposals online through the NIAID electronic Contract Proposal Submission (eCPS) website at https://ecps.niaid.nih.gov.

2) Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at:

https://ecps.niaid.nih.gov/NIAID/Home/HowTo.

5. Formatting, Number of Copies, and Page Limitations

a. Formatting for discs and proposals submitted online through eCPS

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) Pages that are 2-sided will count as two pages.

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

b. Number of copies and applicable page limitations:

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

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

NUMBER OF COPIES AND APPLICABLE PAGE LIMITATIONS

Document Number of Copies Page Limits

Technical Proposal DISC (i.e., CD or DVD) One (1) Disc containing one electronic copy of the Technical Proposal (including all Attachments)

ONLINE (using the eCPS website) One (1)electronic copy of the Technical Proposal (including all Attachments)

Not to Exceed [50 ]pages (inclusive of all Attachments)

Business Proposal DISC (i.e., CD or DVD) One (1) Disc containing two files, as instructed in section II.B above.

ONLINE (using the eCPS website) One (1) submission containing two files, as instructed below.

1. One (1) electronic PDF copy of the Business Proposal (with all Attachments including the PDF rendering of the Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet).

2. One (1) Electronic Cost Proposal Excel Workbook See Solicitation Section J, Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

N/A

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 (January 2007) – FAR 52.215-1

(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 are 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 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

The Government will not pay for the preparation and submission of proposals.

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 the current memorandum dated: December 16, 2013 http://www.hhs.gov/asfr/ogapa/acquisition/policies/promoting-efficient-conference-spending-policy-12-16-2013.html)

Any contract awarded as a result of this BAA 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 for meetings

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:

Mr. Sevag Kasparian, Contracting Officer, Division of Microbiology and Infectious Diseases Branch National Institute of Allergy and Infectious Diseases DEA, Office of Acquisitions 6700-B Rockledge Drive Room 3212, MSC 7612 Bethesda, MD 20892-7612

(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/text-idx?SID=c6cd1f7cece7770f12c306103a90bb1f&node=45:1.0.1.1.52&rgn=div5

K. 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 Limitations

(a) Pursuant to the current and applicable HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual through this contract at a rate in excess the Federal Executive Schedule Level II in effect on the date an expense is incurred.

(b) For purposes of the salary rate limitation, the terms "direct salary," "salary," and "institutional base salary" have the same meaning and are collectively referred to as "direct salary" in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).

Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds.

(c) The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.

(d) See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods.

(End of clause) See the following Web site for 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.)

2) Restriction on Distribution of Sterile Needles

"None of the funds contained in this Act may be used to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any location that has been determined by the local public health or local law enforcement authorities to be inappropriate for such distribution."

3) Restriction on Abortions

“(a) None of the funds appropriated under this Act, and none of the funds in any trust fund to which funds are appropriated in this Act, shall be expended for any abortion. (b) None of the funds appropriated in this Act, and none of the funds in any trust to which funds are appropriated in this Act, shall be expended for health benefits coverage that includes coverage of abortions. (c) The term “health benefits coverage” means the package of services covered by a managed care provider or organization pursuant to a contract or other arrangement.”

4) 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) Restriction on Employment of Unauthorized Alien Workers

The Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien.- As used in this section, the term 'unauthorized alien' means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General."

8) 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.

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 the following requirements in your proposed SOW. 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. Site Visit: Assume three (3) independent site visits through the duration of the contract period of performance.

B. Purchase of Equipment: Costs will NOT be allowed for the purchase of any equipment, hardware, or software.

C. Alterations and Renovations: Costs will NOT be allowed for any facility construction, alterations, or renovations.

D. Programmatic Presentations and Reviews

In performance of the work, offerors are expected to attend the following reviews.

1. Post Award Contract Initiation Review

In preparing the proposal, offerors should include costs for attendance at one Post Award Contract Initiation Review. Offerors should assume a one-day review will be conducted at/near Washington, D.C. or at the contractor site and attendance should include all Key Personnel and all Key Subcontractor personnel.

2. Annual Contract Reviews

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

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

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

V. 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 and quantify the accomplishment of work for the monthly reporting period for the base period and each option and milestone. The obligated funding and the cost incurred will be presented in correlation with percent completion of the activities under the base, option and/or milestone. Performance issues, and any risks to the program should be identified as well as any risk mitigation plans. The format of the monthly report will be finalized as soon as possible upon contract award.

B. Annual Progress Report

This report includes a summation of the technical activities and results for the performance year covered. An Annual Progress Report will not be required for the period when the Final Report is due.

C. 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.

D. Work Plan and Statement of Work

The Contractor shall be required to develop and update the Lead Compound Development Plan (LCDP) and the SOW to incorporate the progress from the effective date of the contract. The Contractor shall submit an updated Plan and SOW for review within sixty (60) calendar days of the effective date of the contract and prior to initiation of product development activities, unless otherwise negotiated with the Contracting Officers Representative (COR) and the Contracting Officer. This updated Plan shall include:

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

2. Activities by fiscal year, Go/No Go criteria and deliverables.

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 (a budget linked to each major activity). The SOW 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 Lead Compound Development Plan and associated SOW when a change to the approved plans is requested.

NOTE: for purposes of this BAA:

The Lead Compound Development Plan describes a synthetic strategy for a compound series, including chemical feasibility of approach that is described by yields, purity, etc. and a plan for conducting studies to refine and optimize a lead compound series to obtain more drug-like properties in order to nominate a compound candidate for further clinical development, and identifies the decision points/gates for progress The SOW describes the activities to be performed within the three (3) year term of award in order to implement the Lead Compound Development Plan and advance the product to selection of a clinical candidate

Note: Contract activities will be divided into manageable non-severable tasks, with duration no longer than two years; preferably less than one year. Initial funding will be for the Base Period only. Funding of subsequent tasks will be funded by Options. Each Option will be fully funded when exercised and will be dependent on successful completion of critical Milestones, including United States Government (USG) acceptance of associated deliverables when applicable. The critical predecessor activities should constitute Go/No Go criteria for successor activities. The contract task-linked budget will be aligned with the Base Period, Options and associated tasks identified in the Lead Compound Development Plan and associated Gantt Chart.

5. Site Visit Reports

Within thirty (30) calendar days of completion of a site visit, the Contractor shall provide copies of the report.

6. Draft and Final Animal Study Protocols

Provide electronic copies of protocols for all animal 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 animal study protocols are expected to undergo at least one round of revision and resubmission for final approval.

7. 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 of receipt of analytical data, 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 activity and/or efficacy of the product for the treatment indication being sought.

8. Copies of FDA Correspondence and Review Summaries

Submit electronic copies of the correspondence or review within five (5) business days of receiving correspondence from or holding a meeting with the

FDA.

9. Invention Reporting

Electronic reporting of inventions shall be required and submitted through iEdison at: https://www.iedison.gov.

10. Technology Transfer

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

11. Other Reports

Copies of other reports for work generated under the BAA may include draft and final reports for Process Development including but not limited to Route Scouting, and Assay Development.

E. DELIVERY SCHEDULE

Delivery of other reports and deliverables will be proposed by the offerors in their technical proposal. They will be developed further after receipt of proposals as a result of finalization of the SOW and other terms and conditions of any resultant contract during negotiations.

F. POST-AWARD REQUIREMENTS

Please note that 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.

1. Contractual Commitments

Upon award of a contract, the contractor shall be required to make legal commitments through acceptance of Government contract clauses. The outline that follows is illustrative of the types of provisions required by the Federal Acquisition Regulations (FAR) that shall be included in the contract.

This is not a complete list of provisions to be included in contracts, nor does it contain specific wording of these clauses. Copies of complete terms and conditions applicable to your contract will be provided during negotiations.

a) Standards of Work. Work performed under the contract must conform to high professional standards.

b) Inspection. Work performed under the contract is subject to Government inspection and evaluation at all times.

c) Termination for Convenience. The Government may terminate the contract at any time for its convenience if it deems termination to be in its best interest, in which case the contractor would be compensated for work performed and for reasonable termination costs.

d) Disputes. Any dispute concerning the contract that cannot be resolved by agreement shall be decided by the Contracting Officer with right of appeal.

e) Equal Opportunity. The contractor will not discriminate against any employee or applicant for employment because of race, color, religion, sex, or national origin.

f) Affirmative Action for Veterans. The contractor will not discriminate against any employee or applicant for employment because he or she is a disabled veteran or veteran of the Vietnam era.

g) Affirmative Action for Handicapped. The contractor will not discriminate against any employee or applicant for employment because he or she is physically or mentally handicapped.

h) Gratuities. The Government may terminate the contract if any gratuities have been offered to any representative of the Government to secure the contract.

i) American-made Equipment and Products. When purchasing equipment or products under a contract award, the contractor shall purchase only American-made items whenever possible.

j) Examination of Records. The Comptroller General (or a duly authorized representative) shall have the right to examine any directly pertinent records of the contractor involving transactions related to this contract.

k) Default. The Government may terminate the contract for default if the contractor fails to perform the work described in the contract and such failure is not the result of excusable delays.

l) Contract Work Hours. The contractor may not require an employee to work more than eight hours a day or forty hours a week unless the employee is compensated accordingly (i.e., overtime pay).

m) Covenant Against Contingent Fees. No person or agency has been employed to solicit or secure the contract upon an understanding for compensation except bona fide employees or commercial agencies maintained by the contractor for the purpose of securing business.

n) Patent Infringement. The contractor shall report each notice or claim of patent infringement based on the performance of the contract.

2. Electronic and Information Technology (SECTION 508)

This is applicable if you are proposing electronic and information technology (EIT) in your proposal:

Electronic and Information Technology Accessibility , HHSAR 352.239-73(a) (January 2010)

a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that, unless an exception applies, all EIT products and services developed, acquired, maintained, or used by any Federal department or agency permit:

1. Federal employees with disabilities to have access to and use information and data that is comparable to the access and use of information and data by Federal employees who are not individuals with disabilities; and

2. Members of the public with disabilities seeking information or services from a Federal agency to have access to and use of information and data that is comparable to the access and use of information and data by members of the public who are not individuals with disabilities.

b. Accordingly, any vendor submitting a proposal/quotations/bid in response to this solicitation must demonstrate compliance with the established EIT accessibility standards. Information about Section 508 visions is available at http://www.section508.gov/ . The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards .

c. The Section 508 accessibility standards applicable to this solicitation are identified in the Statement of Work/Specification/Performance Work Statement. In order to facilitate the Government's evaluation to determine whether EIT products and services proposed meet applicable Section 508 accessibility standards, offerors must prepare an HHS Section 508 Product Assessment Template, in accordance with its completion instructions, and provide a binding statement of conformance. The purpose of the template is to assist HHS acquisition and program officials in determining that EIT products and services proposed support applicable Section 508 accessibility standards. The template allows vendors or developers to self-evaluate their products or services and document in detail how they do or do not conform to a specific Section 508 standard. Instructions for preparing the HHS Section 508 Product Evaluation Template may be found on the HHS Web site ( http://www.hhs.gov/web/508/contracting/technology/vendors.html ).

d. Respondents to this solicitation must also provide any additional detailed information necessary for determining applicable Section 508 standards conformance, as well as for documenting EIT products or services that are incidental to the project, which would constitute an exception to Section 508 requirements.