RFP-NIH-NIAID-DAIDS-99-16

"MICROBIOLOGICAL TUBERCULOSIS DRUG SCREENING"

Request for Proposal No.:

NIH-NIAID-DAIDS-99-16

Issue Date:

September 8, 1998

Issued By:

Ross Kelley, Contract Specialist
AIDS Research Contract Section, NIAID, NIH
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard, MSC 7610
Bethesda, Maryland 20892-7610

Point of Contact:

Ross Kelley, Contract Specialist

Purchase Authority:

Public Law 92-218 as amended

Small Business Set-Aside:

No, SIC Code 8733

Just In Time:

No

Offer Expiration Date:

Offers will be valid for 120 days unless a different period is specified by the Offeror on the form entitled "Proposal Summary and Data Record, NIH 2043."

Proposal Due Date:

November 30, 1998, 4:00 P.M EST

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the requirements of this RFP (NIH-NIAID-DAIDS-99-16) entitled " MICROBIOLOGICAL TUBERCULOSIS DRUG SCREENING." The Government anticipates that one (1) cost reimbursement, completion type contract will be awarded for a period of seven (7) years as a result of this RFP.

The documents included with this electronic RFP package are as follows:

Attachments:

Introduction, Background and Work Statement, dated September 3, 1998

A.1. Safety Control Standards, dated September 3, 1998

A.2. Screening Agreement for Submitting Products to the Division of AIDS (SAMPLE), dated September 3, 1998

Reporting Requirements and Deliverables, dated September 3, 1998
Evaluation Factors for Award, dated September 3, 1998
Specific RFP Instructions and Provisions, dated September 3, 1998
Applicable RFP References, dated September 3, 1998
Proposed Deviation of FAR Clauses FAR 52.227-14 and FAR 52.227-11 After a Determination of Exceptional Circumstances and Revised Clauses, dated September 3, 1998

In addition to the information provided in this document (i.e., The Streamlined RFP), there are five (6) other referenced documents in the Streamlined RFP References that must be retrieved, in whole or in part, in order to submit a proposal. The applicable portions of these referenced documents are explained in Attachment E, Applicable RFP References of this RFP.

If you are unable to download any of the applicable documents, please contact Ross Kelley, Contract Specialist, by phone/fax/Internet. (See contact numbers/addresses below.)

The information contained in this electronic RFP represents all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, the Contracting Officer during discussions will request additional information (if applicable).

Although sufficient information for you or your organization to submit a proposal is provided, if you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Ross Kelley, Contract Specialist, of the NIAID Contracting Office at the Internet address listed below. If you fail to notify the Contracting Office of your interest, you will not receive notice of amendments, which may be issued for this RFP, and this could impact your proposal preparation. All amendments will be posted on the NIH RFP Home Page and the NIAID Contract Management Branch (CMB) Home Page.

The Business and Technical Proposals must be separate from one another in the proposal package as the peer review panel will only receive the Technical Proposal. The Business Proposal must be signed by an authorized official of your organization, and must contain a detailed breakdown of costs by year for each cost category/element. The basis for all costs must be explained and supporting documentation must be submitted with the proposal. (See "STANDARD RFP INSTRUCTIONS AND PROVISIONS," in the NIH RFP Home Page, for more detail on the Business Proposal requirement.)

Within this Web based RFP we have included a template cost spreadsheet in Microsoft Excel. Offerors are requested to complete this spreadsheet and include it with their Business Proposal. This spreadsheet can replace the cost sheets that you ordinarily provide. It is our hope that this spreadsheet will provide you with a useful tool, allow us to more easily understand your cost proposal, and eliminate our need to recreate your spreadsheets. This spreadsheet template is a new approach, and we would appreciate any feedback you could give us about it.

Instructions for delivery of proposals are detailed in Attachment D, Item 5. PLEASE READ THIS ITEM VERY CAREFULLY. The original and five (5) copies of your Technical Proposal and the original and five (5) copies of your Business Proposal must be received by the Contracting Officer no later than November 20, 1998, at 4:00 p.m. local time at the address listed in Attachment D. PLEASE NOTE THAT THE CONTRACTING OFFICE IS THE OFFICIAL ADDRESS FOR RECEIPT OF YOUR TIMELY PROPOSAL. Additionally, fifteen (15) copies of your Technical Proposal must be received by the Scientific Review Program no later than November 30, 1998, at 4:00 p.m. local time at the address listed in Attachment D.

Your attention is further directed to the "Proposal Intent Response Sheet" contained in Attachment D of this document. Please complete this form and return it to this office on or before October 13, 1998. This will allow us to expedite preparations for the peer review of proposals.

The "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your Technical Proposal. It is important that you list all professional personnel and organizations named in the proposal that have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be indicated for every person named. You may use additional sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. This information will be used to ensure that there will be no conflict of interest when selecting review committee members.

Finally, your Technical Proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents" contained in Attachment D of this document.

NOTE: If your proposal is not received by the Contracting Officer or designee at the place and time specified, then it will be considered late and handled in accordance with the PHS CLAUSE 352.215-10, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWAL OF PROPOSALS."

Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction, must be furnished in writing to Ross Kelley, Contract Specialist, at the Internet electronic mail address rk17a@NIH.GOV, or by fax at 301/402-0972. Mr. Kelley can be reached at 301/402-2234. Collect calls will NOT be accepted.

Sincerely,

/s/

Brenda J. Velez
Chief, AIDS Research Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases, NIH

Attachments: A - F

ATTACHMENT A

RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

"MICROBIOLOGICAL TUBERCULOSIS DRUG SCREENING"

INTRODUCTION

The purpose of this contract is to support the National Institute of Allergy and Infectious Diseases (NIAID) in its mission to stimulate research towards discovery of improved therapies for tuberculosis, an opportunistic infection associated with the acquired immunodeficiency syndrome (AIDS) and an increasing health risk to the general population. The rising incidence of tuberculosis, particularly in conjunction with the spread of human immunodeficiency virus (HIV), has contributed to a public health emergency. The emergence of multidrug resistant tuberculosis has produced sizable medical challenges to the treatment and containment of infectious tuberculosis in the face of limited chemotherapeutic options. Active discovery and development efforts for anti-tuberculosis drugs essentially ceased in the 1960's with declining case surveillance and treatment infrastructure.

In order to facilitate the development of improved drugs for the treatment of tuberculosis, and particularly multidrug resistant tuberculosis, the NIAID requires the directed acquisition and evaluation of selected novel synthetic and pure natural product compounds as potential tuberculosis antimicrobials. It is envisioned that compounds will be submitted under confidentiality agreements by pharmaceutical houses or research institutions in exchange for microbiological information on the relative potency of their compounds against Mycobacterium tuberculosis. The goal of this effort will be to encourage the rapid and efficient exploration of new classes of compounds for development as potential anti-tuberculosis agents.

This contract will serve as the central facility for laboratory in vitro testing of novel compounds. Two other contracts (RFP 99-05, RFP 99-15) will provide the facility for coordinating acquisition and data management and for animal efficacy testing, respectively. These three contracts will be highly interactive and will exchange data at least monthly and will formulate directions for testing in conjunction with the Project Officer.

Because of the critical public health need to rapidly identify and develop new candidate drugs to combat tuberculosis, the highly technical nature of the work required, and the numerous microbiological assays producing critical information, close coordination of the Contractors' efforts by the Project Officer will be necessary. At the present time, NIAID has a Microbiological Tuberculosis Screening contract which is scheduled to end on September 30, 1999. The current contractor is through an inter-agency agreement with:

Health Resources and Services Admin., DHHS
Gillis W. Long Hansen’s Disease Center
Y1-AI-5016.

It is anticipated that one contract will be awarded, dependent on availability of funds.

(GENERAL NOTE TO OFFEROR: In responding to this RFP, offerors must describe in detail the responsibilities and level of effort of all proposed personnel who will be assigned to the contract. Documentation shall also be provided on the qualifications, experience, education, competence, availability, and decision-making authority of the Principal Investigator, key personnel, and technical and support staff. Offerors must provide necessary facilities, including all major equipment, and capabilities to perform all the functions of the Work Statement and to safeguard against accidental infection with highly infectious Mycobacterium tuberculosis.

If no single institution has the expertise and facilities required to perform all items in the Work Statement, the Contractor may subcontract a portion of the work. However, the prime Contractor may not subcontract item 1.a. in the Work Statement. If a subcontractor is proposed, similar technical information shall be provided (as part of the proposal) as that required by the prime Contractor (i.e., technical approach, methods, experience, personnel qualifications, facilities, resources, etc.). Cost details shall also be provided by the subcontractor in the Business Proposal. The prime Contractor shall be responsible for all work performed under this contract including that performed by any subcontractor(s) proposed.]

The handling and transportation of all reagents and Government-owned property under this Contract shall be in accordance with all applicable local, state and Federal regulations including health and safety standards (See Attachment A.1 to the Work Statement for details on health and safety standards).]

WORK STATMENT

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

Specifically, the Contractor shall:

1. Evaluate approximately 8000 compounds per year for antimicrobial activity against M. tuberculosis

Screen synthetic and pure natural product compounds per year as potential anti-tuberculosis agents. These compounds shall be provided to the Contractor by the Tuberculosis Antimicrobial Acquisition and Coordinating Facility Contractor and/or by the Project Officer.
Determine the minimal inhibitory concentrations (MIC) of compounds, identified as active in Work Statement 1.a., against virulent, wildtype strains of M. tuberculosis.
Determine the cytotoxicity of compounds, identified as active in Work Statement 1.a., for mammalian cells (IC₅₀).
Determine the MIC and minimal bactericidal concentration (MBC) of compounds, identified as active in Work Statement 1.a., against drug resistant strains of M. tuberculosis.

[NOTE 1 TO OFFEROR: The offeror shall, at the time of proposal, have a validated in vitro system suitable for large scale screening of compounds for potential activity against M. tuberculosis. For determination of the MIC and MBC of compounds against M. tuberculosis in culture, the offeror must document that the proposed methods would be acceptable in accredited clinical microbiology laboratories. For purposes of preparing a cost proposal, the offeror should assume approximately 8,000 compounds will be screened per year under Work Statement 1.a., and that approximately 500 compounds per year will be identified as potentially active through screening and will require further evaluation under 1.b. and 1.c. An advance understanding will be included in any resultant contract stating that all materials supplied to the contractor are to be considered confidential and will be utilized by the contractor solely for research purposes. No unauthorized use of these materials will be permitted.]

2. Evaluate approximately 1000 selected compounds per year for inhibition of replication of intracellular M. tuberculosis.

Evaluate therapeutic agents for efficacy against M. tuberculosis in an in vitro cell culture test system which utilizes intact M. tuberculosis and provides another quantitative assessment of cytotoxicity to human cells for the test therapies. Therapeutic agents will be supplied or approved by the Project Officer for testing.

[NOTE 2 TO OFFEROR: The offeror shall, at the time of proposal, have an in vitro system suitable for evaluation of therapies with potential for treatment of intracellular M. tuberculosis infections in humans. For purposes of preparing a cost proposal, the offeror should assume a total of 1000 therapies will be evaluated per year. Combination studies should not be included in the cost estimations. Quantifiable measures of cytotoxicity due to the test compounds shall be proposed.]

3. Standardize, adopt, and improve new assays for sterilizing activity of compounds against dormant (slowly growing or quiescent) M. tuberculosis organisms.

[NOTE 3 TO OFFEROR: The offeror shall, at the time of proposal, have a proposed in vitro system suitable for evaluation of the effect of therapies against dormant M. tuberculosis. For purposes of preparing a cost proposal, the offeror should assume a total of 100 therapies will be evaluated per year.]

4. Develop and utilize new assays.

Standardize and adopt new assays, as approved by Project Officer, to increase testing efficiency and to employ the latest technological developments.

[NOTE 4 TO OFFEROR: It is conceivable that alternative test systems may emerge in the scientific literature or may need to be developed in order to study specific aspects of candidate therapies. Because the Government does not know if or what alternative assays are likely to be needed, no costs or effort should be included in the cost proposal. It is expected that any necessary modifications of the evaluation system will not increase the negotiated contract cost. The offeror shall include in the proposal some documentation of ability to modify or develop new assays with specific examples of emerging technologies potentially adaptable to microbiological screens.]

5. Provide safe facilities and resources.

Conduct work in accordance with the clause outlined under "SAFETY AND STANDARDS" (See Attachment A.1.).
Conduct work under this contract under Biosafety Level 3 guidelines when appropriate and in accordance with all applicable Federal, state and local laws, codes, ordinances and regulations, and with basic references and related modifications. (See Attachment A.1.)
Provide facilities and equipment to receive, store, and manipulate infectious M. tuberculosis and potentially hazardous compounds and maintain their stability.
Provide protective garments, equipment and sufficient monitoring to assure safe handling of potentially hazardous microorganisms and materials. Specifically, the Contractor shall comply with all applicable health and safety regulations while conducting the work set forth herein.
Insure that no identifiable data on the compounds or products and the results of testing will be kept in files open to the public, and that facilities for computer operation, data entry, and file storage are secure from unauthorized access. Only those contract employees or Government employees directly engaged in this project shall have access to the files of information regarding source and nature of confidential or proprietary materials and results of testing.

[NOTE 5 TO OFFEROR: The offeror shall provide in the Technical Proposal the floor plan of the proposed facility and list equipment and resources dedicated to the project. The offeror shall include a Safety and Health Plan for compliance with Biosafety Level 3 guidelines in the Technical proposal and include a summary of the offeror's safety and health operating procedures manual.

See Attachment A.1 for the DHHS safety and health clause (proposed), which will become part of any resultant contract. Written documentation from a biosafety officer (or equivalent) should be provided (e.g., a safety management program) to assure compliance with all safety guidelines and regulations, training and monitoring of personnel for exposure to infectious or hazardous reagents, and safe disposal of such agents.]

6. Receive, Store, and Record Compounds.

Develop and maintain efficient, effective procedures for documentation of receipt of compound shipments from the acquisition contractor or the Project Officer. Provide for a computerized inventory of compound identifiers, amounts available, storage locations, and standardized microbiological activity.

[NOTE 6 TO OFFEROR: For the purposes of preparing a cost proposal, assume receipt of approximately 12 shipments per year. The offeror shall establish a mechanism for prompt notification of the Project Officer of the dates compounds were received. The offeror shall include details of the proposed notification mechanism and plan in the Technical Proposal.

7. Provide Monthly Reports and Meet with the Project Officer.

Report data generated under this contract to the Project Officer in the form of monthly progress reports and quarterly progress reports as described in the contract Reporting Requirements (written reports and computer files).

To facilitate timely transmission of data and information, the Contractor shall establish and maintain an efficient data management system and electronic communication (electronic mail) with the Project Officer's office and with the Tuberculosis Antimicrobial Acquisition and Coordinating Facility (TAACF).

The Contractor's Principal Investigator and key personnel shall meet with the Project Officer at periodic intervals, to be scheduled after contract award, to review progress, anticipated or existing problems, and discuss the work to be performed.
At least one of the Contractor's key personnel must attend and present information at one NIAID-sponsored meeting per year, at the direction of the Project Officer, on the compounds acquired and analyzed under the Contract.

[NOTE 7 TO OFFEROR: The Offeror should propose a plan for efficient data management and retrieval, as well as for electronic digital communication (including the ability to transmit and receive electronic mail) with the Division of AIDS computer network system. The Government will not authorize purchase of stand-alone computers under this contract for this purpose. The NIAID is connected to the INTERNET and uses IBM-compatible computer hardware for data management and communication. The Offeror should supply an IBM-compatible computer and should submit electronic reports in Microsoft Word version 7.0 for Windows and Microsoft Excel version 7.0 for Windows. For the purpose of preparing a cost proposal, the offeror should assume that monthly reports will be submitted each containing one table of identifiers and data. The offeror should also include costs for quarterly reports and one final report. Guidelines for preparing reports are in Reporting Requirements and Deliverables.

In the Technical Proposal, please list and describe existing computer hardware and software resources available to this project including whether these are Year 2000 compliant or any efforts to provide this capability.

For the purpose of preparing a cost proposal, assume a minimum of 3 visits of one key personnel per year to 6003 Executive Boulevard, Rockville, MD 20852 to meet with the Project Officer for one day and attendance of one key personnel for four days at the annual meeting of the National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections to be held in the greater Washington, D.C. area.]

8. Maintain confidentiality of data.

The Contractor shall be bound by the same terms as the Government with respect to the confidential nature of information provided by contributing suppliers. The Contractor shall provide advance copies of draft manuscripts for publication (including abstracts and public presentations) based on data generated under this contract to the Project Officer, and obtain clearance before submitting for publication or presentation. Support from the Government contract must be acknowledged in all abstracts, presentations, and publications.

[NOTE 8 TO OFFEROR: An Advance Understanding will be inserted in any resultant contract, stating the following: 1. The Contractor agrees that manuscripts/abstracts based on data/information generated under this contract shall not be submitted for publication until written Project Officer clearance has been received.

A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information; and 2. The Contractor agrees they will operate in accordance with the Government regarding the confidential nature of information provided by contributing suppliers or through the Project Officer under the standard "Screening Agreement for Submitting Products to the Division of AIDS' ( See the Sample Screening Agreement Attachment A.2. to the Statement of Work.)]

9. Ensure an orderly transition to a successor Contractor.

By the end of the sixth year of this contract, the Contractor shall have developed and submitted procedures for an orderly transition of data and samples to a subsequent Contractor or to the Government, subject to Project Officer approval, and shall deliver, if requested by the Project Officer and by the expiration date of the Contract, the following items: original data and any necessary information related thereto, and any Government-owned property, if applicable.

ATTACHMENT A.1
RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

SAFETY CONTROLS AND STANDARDS

In order to provide safety controls for protection to the life and health of employees and other persons; for prevention of damage to all property, and for avoidance of work interruptions in the performance of the contract, the Contractor and any subcontractors shall comply with the following standards or subsequent issues or any supplements. In addition, the Contractor shall comply with all applicable Federal, state and local laws, codes, ordinances and regulations, including obtaining of all required licenses and permits in connection with biological and hazardous materials.

(1) The Biosafety Microbiological and Biomedical Laboratory Guidelines, Centers for Disease Control and Prevention and the National Institutes of Health, third edition, HHS Pub. No. (CDC) 93-8395 published by the U.S. Government Printing Office, May 1993, stock number 17-040-00523-7.

(2) Recommendations for the Safe Handling of Cytotoxic Drugs, NIH Publication No. 92-2621.

(3) NIH Guidelines for the Laboratory Use of Chemical Carcinogens, NIH Publication No. 81-2385.

Copies of the above may be obtained from the Government Printing Office or:

Division of Safety
Office of Research Services
National Institutes of Health
Building 31 - Room 1C02
Bethesda, Maryland 20892

301-496-2960

(4) SAFETY AND HEALTH CLAUSE

In order to help ensure the protection of the life and health of all persons, as well as to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State, and local levels (Federal, State, and local regulatory/enforcement agencies).

Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required of performance of any part of work under this contract, an equitable adjustment will be made in accordance with whichever applicable "Changes" Clause as set forth in this contract (FAR 52.243-1, Changes-Fixed Price; FAR 52.243-2, Changes-Cost-Reimbursement; or FAR 52.243-3, Changes-Time and Materials or Labor-Hours).

The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contact and all violations for which the Contractor has been cited by any Federal, State, or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

If the Contractor fails or refuses to comply promptly with the Federal, State, or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.

ATTACHMENT A.2
RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

(SAMPLE)

Screening Agreement for Submitting Products to the Division of AIDS

1. The organization providing compounds for evaluation ____________________ (SUPPLIER) may supply products, patented or unpatented, to the Division of AIDS (DIVISION), which may then screen and test them for possible treatment for tuberculosis. If agreed to in writing by the SUPPLIER and the DIVISION, but not unless such written agreement is obtained, these products may also be entered into screening and testing as anti-viral, anti-bacterial, anti-fungal, anti-parasitic, immunomodulating, and biological modifying agents with potential for treatment of AIDS and associated opportunistic infections.

Using protocols evaluated and approved mutually by the DIVISION and the SUPPLIER, the products will be screened by one or more of the DIVISION's contract testing laboratories (SCREENING CONTRACTORS) but will not be placed in the laboratories of any company in or affiliated with the pharmaceutical or chemical industries without the SUPPLIER's written permission.

2. In order to facilitate record keeping and handling of confidential materials, the following procedures will be used by the DIVISION:

The SUPPLIER shall forward to the acquisition contractor ( ) the products to be tested together with data sheets in duplicate for each product, giving pertinent available data as to chemical constitution, stability, solubility, toxicity, previous biological efficacy and any precautions that need to be followed in handling, storing, shipping and/or testing.
It is clearly understood that no data about the products, whether provided by the SUPPLIER or generated by the DIVISION or ( ), and the results of the testing will be kept in any files open to the public either by the DIVISION, SCREENING CONTRACTORS, or ( ). Only those employees directly engaged in the operation of the DIVISION will have access to the files of information regarding source and nature of confidential materials, and results of testing, except as required pursuant to the Freedom of Information Act, 5 U.S.C. 552. In no case will information properly designated as proprietary or confidential by the SUPPLIER need to be released under this Act.
Whenever possible the SUPPLIER will be given the choice of the DIVISION's SCREENING CONTRACTORS, although at present there is no preference; and it is understood that the DIVISION reserves the right to send the SUPPLIER's products to other SCREENING CONTRACTORS if the need arises. It is furthermore understood that the contracts between the DIVISION and the SCREENING CONTRACTORS will contain provisions to safeguard the SUPPLIER's rights under this Agreement.
Because the DIVISION's screening effort will be accomplished in collaboration with the DIVISION's scientific staff and ( ) project team, as well as the SUPPLIER's own staff, the DIVISION will use its best efforts to facilitate rapid ongoing communications of screening data to the SUPPLIER.

3. Although the SUPPLIER recognizes that the interchange of information is generally desirable in the field of treatment for tuberculosis infections, it is mutually understood that the SUPPLIER, in voluntarily supplying appropriately marked information deemed proprietary, including product and information regarding this product hereunder, is entitled to protection for any such technical information it may furnish.

It is understood and agreed to, subject to applicable law, that the SUPPLIER shall retain all rights to those products in which the SUPPLIER has a proprietary interest. To clarify, the finding of activity in the designated screens does not result in any intellectual property rights for (__________) or the SCREENING CONRACTORS. The DIVISION agrees to notify the SUPPLIER of the names of the SCREENING CONTRACTORS prior to submitting SUPPLIER’S products to them. Subject notwithstanding, to the provision that, with respect only to those products determined by means of the various screening and testing processes to possess such significant activity (strong potential to be scheduled for clinical trial by the DIVISION, using mutually approved protocols), the Government shall have a royalty-free, irrevocable, nonexclusive license for clinical trials under any patent that the SUPPLIER may have or obtain on such product or on a process for use of such product, to manufacture and/or use by or for the Government the invention(s) claimed by the patent(s) only for medical research purposes related to the treatment of tuberculosis.
The DIVISION and SUPPLIER agree that publication of screening results is worthwhile and should be governed by the following: Specifically:

With regard to screening results on compounds in which the SUPPLIER has a proprietary interest, and that the DIVISION deems significant for research on tuberculosis, the SUPPLIER agrees that the DIVISION may publish or otherwise disclose such results only with the written permission of the SUPPLIER, and that the SUPPLIER will not unreasonably withhold such permission. SUPPLIER in that regard agrees to pursue appropriate patent coverage in a timely manner, or to allow the Government to do so.
The SUPPLIER will inform the DIVISION prior to publishing screening data along with the available biological and physical data; appropriate credit shall be given to the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID-NIH).
In no case will the DIVISION publish information identifying the SUPPLIER as the source of a product without written approval from the SUPPLIER; appropriate credit shall be given to the SUPPLIER.

Following the receipt of complete test results by the DIVISION, the SUPPLIER will receive in a timely manner a full report including all screening data. The products scheduled for clinical trial, referred to herein under paragraph 3a, shall be designated by the DIVISION, and the aforementioned report will specify the products so selected. The SUPPLIER has the right to proceed with clinical trials in a timely manner at its own expense. The DIVISION agrees to assist the SUPPLIER with assessing the clinical potential of candidate compounds.

The DIVISION is confident that this agreement will lay the basis for mutually satisfactory cooperation in the field and in the treatment of AIDS and associated diseases.

In agreeing to the above, the SUPPLIER signs below, as well as the attached duplicate of this agreement, and returns both to the DIVISION for countersignature. One original will be returned for the SUPPLIER's files.

______________________	______________________
Director, Division of AIDS NIAID, NIH	Name (Signature)
	______________________
	Title
______________________	______________________
Date	Company
	______________________
	Address
	______________________
	Date

ATTACHMENT B

RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

REPORTING REQUIREMENTS AND DELIVERABLES

The Contractor shall submit technical progress reports covering the work accomplished during each reporting period. Distribution of written reports is listed below in E.

A. Monthly Reports.

A high degree of interaction, cooperation, and communication will be required by the Contractor and the Contractor for the Tuberculosis Antimicrobial Acquisition and Coordinating Facility (TAACF). Therefore, reporting requirements will include reports to be exchanged between the contracts as well as to the Project Officer. The following represent the minimum requirements:

1. The Contractor shall submit a shipment receipt summary to the Contractor for the Tuberculosis Antimicrobial Acquisition and Coordinating Facility and the Project Officer every month by the fifteenth calendar day of the month. This summary will include details of all shipments received during the previous calendar month such as the shipment number, compound code identifiers, condition of compound received (including color), the date of receipt, and microbiological data generated on each compound, and assay identifier(s). This report shall be submitted both as one paper copy and as digital computer files on a 3.5 inch high density diskette or through modem transfer to Contractor for the Tuberculosis Antimicrobial Acquisition and Coordinating Facility and the Project Officer. The computer files must be compatible with the Division of AIDS, Therapeutics Research Program (TRP) Tuberculosis Database software (ISISÔ/Base) and appropriate licensing or software purchases shall be provided by Contractor A for use at Contractor B's site.

B. Quarterly Reports.

By the fifteenth calendar day after completion of each quarter, the Contractor shall submit 2 paper copies of the progress report of work performed in the previous quarter AND 1 copy on magnetic media as computer files in Microsoft Word^TM version 7.0 for Windows for text and Excel^TM version 7.0 for Windows for tables and ISIS/Base^TM format readable using an IBM-type personal computer. It remains the responsibility of the Contractor to assure receipt by the indicated government official listed below of all reports by the established due dates. A quarterly report is not required in the quarter that the final report is due. Quarterly reports will be submitted in addition to monthly reports.

Each quarterly report shall consist of:

A cover page containing:

Contract number and title;
Period of performance being reported;
Contractor's name and address;
Author(s); and
Date of submission.

A table of contents indicating page number for each major section.
Summary of all compounds acquired and test results obtained during the quarter.
Cumulative summary of all compounds acquired and test results obtained under the contract.
Summary of current technical or administrative problems encountered, their resolution or the proposed corrective action.

C. Final Report

The Contractor shall submit 4 paper copies of the final report which documents and summarizes the results of the entire contract for the period of performance AND as 1 copy on digital, magnetic media as computer files in Microsoft Word^TM version 7.0 for Windows for text and Excel^TM version 7.0 for Windows for tables readable using an IBM-type personal computer, or as specified by the Project Officer. This report will provide a final inventory and contain a cover page described in B.1. above and the information required in B.2. through B.5. above. The final report shall be submitted by the completion date of the contract.

D. Other Deliverables.

The Contractor, subject to Project Officer approval shall deliver to the Government or its designee by the completion date of the contract, the following items (with the exception of item (4) which shall be delivered by the end of the sixth year or earlier as directed by the Project Officer).

A computer-generated listing of accurate and updated information on compound inventory, including activities of the Contractor, data files, original data and any necessary information related thereto;
Labeled and inventoried paper files;
Any other government-owned property;
The transition plan required in item #9 of the Work Statement;
One complete copy of the final, updated and verified Tuberculosis Database as a computer file;
A written assurance from the authorized institutional official that all files containing data relating to this contract have been destroyed.

E. Technical Reports Distribution

Report	No. of Copies	Addressee/Distribution	Due Dates
Quarterly	2*	Project Officer, OIRB, TRP Division of AIDS, NIAID Solar Building, Room 6003 Executive Blvd. MSC 7620 Bethesda, MD 20892-7620	Quarterly
Quarterly	Original	Contracting Officer, ARCS CMB, NIAID Solar Building, Room 3C07 6003 Executive Blvd. MSC 7610 Bethesda, MD 20892-7610	Quarterly
Monthly	1*	Same as Project Officer above.	Monthly
Monthly	Original	Same as Contracting Officer above	Monthly
Final	4*	Same as Project Officer above.	Completion date
Final	Original	Same as Contracting Officer above.	Completion date

* plus one copy on 3.5 inch, high density computer diskette or other digital medium approved by the Project Officer.

F. If the Contractor is unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons therefor.

ATTACHMENT C

RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

EVALUATION FACTORS FOR AWARD

1. GENERAL

Selection of an offeror for contract award will be based on an evaluation of proposals against two factors. The factors in order of importance are: technical and cost. Although technical factors are of paramount consideration in the award of the contract, cost/price are also important to the overall contract award decision.

Offerors are advised that award will be made to that offeror whose proposal provides the best overall value to the Government. In accordance with FAR 15.305, proposals will be subject to a cost realism analysis by the Government.

The evaluation will be based on the demonstrated capabilities of the prospective contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Proposals will be judged solely on the written material provided by the offeror.

2. MANDATORY QUALIFICATION CRITERION

The following qualification criterion establishes conditions that must be met at the time the final technical and cost proposal revisions are submitted in order for proposals to be considered for award:

Offerors shall provide documentation that appropriate facilities are available for that portion of the project utilizing virulent M. tuberculosis to be conducted at Biosafety Level 3 as described in The Biosafety Microbiological and Biomedical Laboratory Guidelines, Centers for Disease Control and Prevention and the National Institutes of Health, third edition, HHS Pub. No. (CDC) 93-8395 published by the U.S. Government Printing Office, May 1993, stock number 17-040-00523-7. The documentation shall include a signed statement by the institutional official authorized to commit to a contractual agreement that the proposed work plan, staff biosafety training plan, and risk assessment evaluation have been reviewed and approved by the Institutional Biosafety Committee. A listing of the committee's membership with names, titles, and affiliations and a copy of the approval memorandum or letter from the committee chair must be included.

3. COMPARATIVE IMPORTANCE OF PROPOSALS

The technical proposal will receive paramount consideration in the selection of the Contractor(s) for this acquisition, but not to the exclusion of cost or price. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. During the source selection process, the closer that offerors are determined to be in technical ability, the greater the importance of cost or price. When offerors are considered to be essentially equal in technical ability, a greatest value analysis will be conducted to determine the award.

The Government reserves the right to make an award based on the greatest value to the Government in terms of cost or price, and other factors.

4. PROPOSAL EVALUATION CRITERIA

Proposals submitted in response to this RFP will be evaluated based on the following factors which are listed and weighted in order of their relative importance. Proposals will be judged solely on the written material provided by the offeror. It is anticipated that one award will be made as a result of this acquisition, dependent on the availability of funds.

1. Technical Approach - Total Points = 50

The technical adequacy and feasibility of the approach presented in the technical proposal, as reflected in the documentation provided including the alternative strategies and relevant experience, for:

(a) Understanding of the problem (25 points)

Evidence of understanding of the proposed project and of the disease;
Evidence of understanding of the anti-infective drug development process;
Adequacy of understanding of the metabolism and pathobiology of M. tuberculosis, particularly related to interpretation of preclinical drug evaluations;
Adequacy of plans for protection of confidential and proprietary information;
Demonstrated skill in developing and validating screening assays.

(b) Suitability of procedures (25 points)

Appropriateness, documented reproducibility of screening assay;
Appropriateness, reproducibility of MIC and MBC assays;
Adequacy of plans for coordination of antimicrobial testing;
Technical suitability of intracellular assays;
Interpretation and reporting of results.

2. Personnel Qualifications - Total Points = 40

(a) Principal Investigator: (20 points)

Relevance and quality of recent work;
Demonstrated experience with technical approaches required;
Documented availability for the proposed project;
Documented experience with managing projects of similar complexity.

(b) Other personnel/staffing plan (20 points)

Relevance and extent of experience of other professional and research technical and support staff and their documented capability to conduct proposed studies;
Documented experience in similar projects and appropriate computer skills;
Adequacy of the staffing plan, including clear lines of authority and the time commitment of the professional and technical staff, for the conduct of the project.

3. Facilities and Resources - Total Points = 10

(a) Documented availability of adequate facilities (suitable office, computer, and laboratory space), equipment, and resources necessary to meet the requirements of the RFP.

Note: A detailed floor plan of the proposed facility which shows location of the equipment and resources to be dedicated to this project shall be provided.

(b) Adequacy of plans for compliance with all safety guidelines and regulations, including training and monitoring of personnel for exposure to hazardous chemical and biological agents, and safe disposal of such agents.

(c) Documentation of facilities to receive and store compounds, and maintain their stability.

TOTAL: 100 Points

ATTACHMENT D

RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

SPECIFIC RFP INSTRUCTIONS AND PROVISIONS

NOTICE TO OFFERORS: This attachment contains proposal instructions and information that are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general information, and forms regarding proposal preparation are contained in Attachment E, "Applicable RFP References ."

NUMBER AND TYPE OF AWARD(S)

It is anticipated that one (1) award will be made from this solicitation on/about August 17, 1999.

It is anticipated that the award from this solicitation will be a cost reimbursement completion type contract with a seven (7) year performance period, and that incremental funding will be used.

ESTIMATE OF EFFORT

It is expected that one completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the seven (7) year total effort to be approximately 4,830%, (690% per year). This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

As further assistance, it is estimated that the above total labor effort is constituted as follows:

Labor Category	Annual Effort	Total
Principal Investigator	30%	210%
Co-PI	50%	350%
Professional Staff (Ph.D)	10%	70%
Post-Doctoral	100%	700%
Microbiologists	400%	2,800%
Data Coordinator	100%	700%
TOTAL	690%	4,830%

These percentages are based on a 12-month calendar year.

SIC 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 REPRESENTATIONS, FAR 52.219-1:

The standard industrial classifications (SIC) code for this acquisition is 8733.

(1) The small business size standard is $5,000,000.

(2) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is $5,000,000.

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 Standard Industrial Classification (SIC) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.

SERVICE OF PROTEST (AUG 1996) - FAR 52.233-2

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 General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Hand-Carried Address:

Paul D. McFarlane, Contracting Officer, ARCS
Contract Management Branch, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

Mailing address (U.S.) Postal Service

Paul D. McFarlane, Contracting Officer, ARCS
Contract Management Branch, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

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

PACKAGING AND DELIVERY OF THE PROPOSAL

Your proposal shall be organized in accordance with the guidance provided in "Standard RFP Instructions and Provisions." Shipment and marking shall be as indicated below.

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

"RFP NO. NIH-NIAID-DAIDS-99-16
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES

PLEASE NOTE THAT THE TECHNICAL PROPOSAL SHALL BE SENT IN SPLIT SHIPMENTS TO TWO LOCATIONS. PLEASE READ THE FOLLOWING INFORMATION CAREFULLY.

The number of copies required of each part of your proposal are as specified below.

a. TECHNICAL PROPOSAL: ORIGINAL AND 5 COPIES

BUSINESS PROPOSAL: ORIGINAL AND 5 COPIES

NOTE: The original proposal must be readily accessible for date stamping.

COPIES TO

If hand-delivered or delivery service

Ross Kelley, Contract Specialist, ARCS
Contract Management Branch, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

If using U.S. Postal Service

Ross Kelley, Contract Specialist, ARCS
Contract Management Branch, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

b. TECHNICAL PROPOSAL: 15 COPIES

COPIES TO

If hand-delivered or delivery service

Scientific Review Program (Review Processing Unit) DEA, NIAID, NIH
Solar Building, Room 4C15
6003 Executive Boulevard
Rockville, MD 20852

If using U.S. Postal Service

Scientific Review Program (Review Processing Unit), DEA, NIAID, NIH
Solar Building, Room 4C15
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Rockville, Maryland, address. Any package sent to the Rockville 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. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal," in accordance with PHS 352.215-10, Late Proposals, Modifications of Proposals and Withdrawal of Proposals (NOV 1986).

GOVERNMENT NOTICE FOR HANDLING PROPOSALS

AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS TECHNICAL PROPOSAL.

"This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices which the submitter places on this proposal shall also be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be mad e only to the extent authorized by, and in accordance with, the procedures in HHSAR paragraph 315.608-72."

(For information regarding authorized restrictive notices, offerors should refer to the "Confidentiality of Proposals" section, Item F.6., of the STANDARD RFP INSTRUCTIONS AND PROVISIONS, General Instructions.)

SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUG 1997)

To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State, and local levels (Federal, State, and local regulatory/enforcement agencies).
Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required of performance of any part of work under this contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause as set forth in the contract.
The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contact and all violations for which the Contractor has been cited by any Federal, State, or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.
If the Contractor fails or refuses to comply promptly with the Federal, State, or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.
The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.

PROPOSAL INTENT RESPONSE SHEET

RFP No.: NIH-NIAID-DAIDS-99-16

RFP Title: "MICROBIOLOGICAL TUBERCULOSIS DRUG SCREENING"

Please review the attached Request for Proposals. Furnish the information requested below and return this page by October 13, 1998. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:

Company/Institution Name: ______________________________________

Address: _____________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________

Project Director's Name: ________________________________________

Title: _________________________________________________________

Signature/Date: ________________________________________________

Telephone Number and E-mail Address: ___________________________

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants):

_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________

(Continue list on a separate page if necessary)

RETURN TO:

CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Attn: Ross Kelley
RFP-NIH-NIAID-DAIDS-99-16
FAX# 301/402-0972

Email rk17a@nih.gov

TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT

(NOTE: Instructions to offerors are indicated in parentheses or as footnotes.)

1.	TECHNICAL PROPOSAL COVER SHEET	Page 1
2.	TECHNICAL PROPOSAL TABLE OF CONTENTS	Page 2
3.	SUMMARY OF OBJECTIVES AND METHODS (Abstract)*	Page 3
4.	TECHNICAL PLAN (Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions.)
	STATEMENT OF WORK 1. Objectives 2. Approach 3. Methods 4. Schedule	Page 4 Page _ Page _ Page _
	PERSONNEL (List by name, title, department and organization, and detail each person’s qualifications and role in the Project. Provide narrative.) 1. Principal Investigator/Project Direct Other Investigators Additional Personnel (e.g., technical support, subcontractors, Consultants) (Note: For key personnel, include 2-page biosketch/resume and the form entitled "Summary of Current and Proposed Activities.")	Page _
	FACILITIES/RESOURCES AND DIRECT COSTS (List/describe all equipment, facilities and other resources available for this project; attach "Technical Proposal Cost Information" form, and marked floor plan.)	Page _
	OTHER CONSIDERATIONS (Provide brief narrative of any unique arrangements, safety procedures in place, etc.)	Page _
5.	"Technical Proposal Cost Information" summary spreadsheet	Page _
6.	LITERATURE CITED	Page _
7.	APPENDICES (Protocols, policy manuals, etc. for above Technical Plan; list each Appendix; Appendices must be clear and legible, and easily located.) * State the proposal's broad, long-term objectives and specific aims. Describe concisely the research design and methods for achieving these goals. DO NOT EXCEED ONE PAGE in providing the abstract. Identify the RFP number, institution, and Principal Investigator on the abstract.

ATTACHMENT E
RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

APPLICABLE RFP REFERENCES

This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.

The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as otherwise may be modified by the inclusion of an item from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS".
The following items are applicable from the file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS:"

LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWAL OF PROPOSALS, PHS 352.215-10
SMALL, SMALL DISADVANTAGED AND WOMEN OWNED SMALL BUSINESS SUBCONTRACTING PLAN (does not apply to small business or to work performed in foreign countries)

Note: A Subcontracting Plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due.

The following items/files are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS":

Applicable to Technical Proposal

Applicable to Business Proposal

Proposal Summary and Data Record, NIH-2043
Business Proposal Cost Information
Disclosure of Lobbying Activities, OMB Form SF-LLL
Excel Cost Spreadsheet (Template provided)

To Become Contract Attachments

Invoice/Financing Requests Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1, May 1997
Safety and Health Deviation PHS 352.223-70 (August 1997)
Screening Agreement for Submitting Products to the Division of AIDS
Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984
Form NIH 2706 (Financial Report) and Instructions for Completing Form NIH 2706 Note: Financial reports are not always required. This will be discussed during negotiations.

Other-to be submitted as directed by Contracting Officer

Certificate of Current Cost or Pricing Data, NIH-1397

The "Representations and Certifications" are applicable.
The "Sample Contract Format-General" is applicable. In addition, the following Advance Understandings will be inserted in SECTION B of the resultant contract: (1) The NIAID shall be notified if the Contractor’s conflict of interest status has changed and that a determination shall be made regarding the continuation of the contract. (2) All materials supplied to the Contractor are to be considered confidential and will be utilized by the Contractor solely for research purposes. No unauthorized use of these materials will be permitted. (3)The Contractor accepts the contract with deviation from FAR Clauses 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (June 1989) and 52.227-14, Rights in Data-General (June 1987). The Contractor shall operate in accordance with the Government’s direction regarding the confidential nature of information provided by contributing suppliers (or provided by the Project Officer) under the "Screening Agreement for Submitting Products to the Division of AIDS" (Work Statement Attachment A.2) which shall be used for all suppliers.

ATTACHMENT F

RFP-NIH-NIAID-DAIDS-99-16
September 3, 1998

PROPOSED DEVIATION OF FAR CLAUSES FAR 52.227-11 and FAR 52.227-14 AFTER A DETERMINATION OF EXCEPTIONAL CIRCUMSTANCES

This contract represents one segment of the drug discovery and development program within the Division of AIDS, NIAID. AIDS-associated opportunistic infections such as tuberculosis are difficult to treat with existing antibiotics, and discovery of new drugs is not being actively pursued by the pharmaceutical industry. This project is intended to accelerate development of new therapies by encouraging owners of promising proprietary compositions to submit them for evaluation under this contract. NIAID also intends to shepherd certain compositions (or processes) to the point of commercial development, where it could offer a commercial collaborator an attractive package of intellectual property rights which would give the collaborator the incentive to undertake the substantial investment needed to commercialize the composition or process and make it widely available to the public in the shortest practicable time.

The NIAID seeks to attract suppliers having highly promising compositions for evaluation by making available standardized, validated efficacy testing systems such as will be provided by this contract. This contract will make available testing systems for evaluating candidate antibiotics against certain opportunistic infections and require specialized procedures, biosafety precautions, and technical expertise not usually available to academic, government, and pharmaceutical industry chemists. By providing information on biological activity developed under this contract to suppliers of candidate compositions, the NIAID seeks to stimulate research and development in all sectors of the scientific community.

In addition, newly discovered antibiotic activity may require further testing and preclinical development within other components of the NIAID drug development program. Information on biological activity, physicochemical properties, and chemical structure must be protected in order to safeguard the rights of collaborating parties and thus to facilitate commercialization of new therapeutics for people with AIDS-associated opportunistic infections.

Because the goal of the NIAID drug discovery/development program is to promote the availability of new drugs, it will be necessary to restrict certain rights of the contractor providing the standardized testing to either attract suppliers of proprietary compositions or enable NIAID to offer a package of intellectual property rights to a collaborator for commercialization. It is anticipated that the great majority of compounds submitted to the NIAID for testing will be proprietary, and our experience has demonstrated that suppliers are reluctant to provide new chemical compositions or processes without complete assurance that their intellectual property rights are protected. In addition to the need to protect third party suppliers' proprietary rights, it is also necessary to consolidate into a single package the intellectual property rights that may arise in the performance of multiple contracts within the NIAID drug discovery program. This packaging of rights is much more likely to attract the large capital investment by pharmaceutical companies that is required to bring candidate drugs to market. Furthermore, in order to protect the intellectual property rights, the timing of data publication will need to be restricted in order for patent applications to be filed on inventions arising from the contract. Thus, the NIAID intends to seek a deviation from FAR clause 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (June 1989) and from FAR clause 52.227-14, Rights in Data-General (June 1987).

Pursuant to a determination of exceptional circumstances as required by FAR 27.303, the clause at FAR 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (June 1989) will be modified to restrict the contractor's rights to subject inventions arising under the contract. The modified clause will state that potential drug sponsors (compound suppliers) shall retain all pre-existing rights to those compounds or products in which the drug sponsor has a proprietary interest. Discoveries obtained under the contractor’s routine screening will be assigned to the compound supplier. These requirements will be included in an additional clause, FAR 52.227-11, Patent Rights – Deviation, which will be added to the contract.

Specifically, the contractor will be required to assign to the Government or, if deemed appropriate by the NIAID and subject to certain rights reserved to the Government, to a collaborating party designated by the Government the entire right, title and interest throughout the world to each subject invention, except to the extent that rights are retained by the Contractor under the Greater Rights Determination provision of the clause. The contractor may request greater rights to an identified invention, and the NIH will consider whether granting the requested rights will interfere with rights of the Government or any collaborating party or otherwise impede the ability of the Government or others to develop and commercialize new therapies to improve the treatment of AIDS in a rapid, efficient and cost effective manner. Intellectual property rights for discoveries beyond the scope of the screening activities of the contract or other unanticipated discoveries developed by the Contractor without the use of proprietary compounds will remain with the contractors, and will be subject to the clause at FAR 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (June 1997). Contractors are encouraged to request greater rights where inventions relate to technology outside NIAID's program and where the contractor has negotiated with a supplier of a proprietary composition for the disposition of patent rights concerning a subject invention related to the composition.

Although NIAID encourages the publication of articles on research results, FAR 52.227-14 Rights in Data-General (June 1987) also will be narrowly modified to restrict the Contractor's right to use, release to others, reproduce, distribute, and publish data produced or used by the contractor in the performance of this contract in order to protect the supplier's proprietary rights, to protect data that will be submitted as part of a regulatory filing, and to delay the publication of data as necessary to obtain patent protection. NIAID will reserve the right to coordinate the timing of data publication with the supplier so that appropriate domestic and international invention applications may be filed. In general, a reasonable delay in publishing is expected to be less than six months. An additional FAR clause 52.227-14, Deviation, also will be included in the contract.

FAR 52.227-11 Patent Rights (Deviation)

This clause deviation applies to discoveries resulting from routine screening activities involving the use of proprietary compounds. Discoveries resulting from research activities pertaining to the development of new screening assays or other unanticipated discoveries developed by the Contractor without the use of proprietary compounds will be covered by the standard patent rights clause (FAR 52.227-11, Patent Rights - Retention by the Contractor (Short Form) (June 1997))

(a) Definitions.

(1) "Invention" means any invention or discovery which is or may be patentable or otherwise protectable under title 35 of the United States Code, or any novel variety of plant which is or may be protected under the Plant Variety Protection Act (7 U.S.C. 2321, et. seq.)

(2) "Made" when used in relation to any invention means the conception or first actual reduction to practice of such invention.

(3) "Nonprofit organization" means a university or other institution of higher education or an organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.

(4) "Practical application" means to manufacture, in the case of a composition or product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

(5) "Small business firm" means a small business concern as defined at section 2 of Pub. L. 85-536 (15 U.S.C. 632) and implementing regulations of the Administrator of the Small Business Administration. For the purpose of this clause, the size standards for small business concerns involved in Government procurement and subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively, will be used.

(6) "Subject invention" for the purpose of this clause means any invention of the contractor conceived or first actually reduced to practice in the performance of work under this contract, provided that in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act, 7 U.S.C. 2401(d)) must also occur during the period of contract performance. It does not refer to research activities that lead to the development of new screening assays or other discoveries not directly related to the scope of this contract. These new screening assays or other unanticipated discoveries developed by the Contractor without the use of proprietary compounds will not be subject to the provisions of this deviation but will be covered by the standard Patent Rights Clause which is also incorporated in this contract.

(7) "Compound Suppliers" means any entities or organizations designated by the NIAID that supply to NIAID a product, patented or unpatented, which may be submitted for screening and testing for possible treatment of viral diseases including HIV and associated opportunistic infections.

(8) "NIAID" means the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH).

(9) "NIH" means the National Institutes of Health.

(b) Allocation of principal rights.

(1) Retention of pre-existing rights. Compound Suppliers shall retain all pre-existing rights to those compounds in which the compound supplier has a proprietary interest.

(2) Assignment to the NIH or Compound Supplier. The Contractor agrees to assign to the NIH or to a Compound Supplier designated by NIAID, the entire right, title, and interest throughout the world to each subject invention except to the extent that rights are retained by the Contractor under subparagraph (b)(3) of this clause and subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the United States government to practice or have practiced the subject invention for or on behalf of the United States throughout the world.

(3) Greater Rights Determinations. The Contractor, or an employee-inventor after consultation by the NIAID with the Contractor, may request greater rights to an identified subject invention of the contract in accordance with the procedures of FAR paragraph 27.304-1(b) (and FAR paragraph 27.304-1(c) in the case of an employee-inventor). The NIAID is more likely to grant greater rights if the compound is proprietary to the Government or the supplier is not interested in developing the invention. In addition to the considerations set forth in paragraph 27.304-1(b), NIAID will consider whether granting the requested greater rights will interfere with rights of the Government or any Compound Supplier or otherwise impede the ability of the Government or the Compound Supplier to develop and commercialize new compounds, dosage forms, therapies, technologies or other approaches with potential for the treatment of viral diseases including HIV and associated infections in a rapid, efficient, and cost effective manner. A request for a determination of whether the Contractor or the employee-inventor is entitled to retain such greater rights must be submitted to the NIAID Contracting Officer at the time of the first disclosure of the invention pursuant to subparagraph (c)(1) below, or not later than eight (8) months thereafter, unless a longer period is authorized in writing by the Contracting Officer for good cause shown in writing by the Contractor. Each determination of greater rights under this contract shall be subject to paragraph (c) of the FAR clause at 52.227-13, and to any reservations and conditions deemed to be appropriate by NIAID such as the requirement to assign or exclusively license the rights to subject inventions to the Compound Supplier. A determination by NIAID denying a request by the Contractor for greater rights in a subject invention may be appealed within 30 days of the date the Contractor is notified of the determination to an agency official at a level above the individual who made the determination. If greater rights are granted, the Contractor must file a patent application on the invention. Upon request, the Contractor shall provide the filing date, serial number and title, a copy of the patent application (including an English-language version if filed in a language other than English), and patent number and issue date for any subject invention in any country for which the Contractor has retained title. Upon request, the Contractor shall furnish the Government an irrevocable power to inspect and make copies of the patent application file.

(1) The Contractor will disclose each subject invention to the NIAID Contracting Officer as provided in paragraph (j) within two months after the inventor discloses it in writing to Contractor personnel responsible for patent matters. The disclosure to the NIAID Contracting Officer shall be in the form of a written report and shall identify the contract under which the invention was made and the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electrical characteristics of the invention. The disclosure shall also identify any publication, on sale (offer for sale), or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been accepted for publication at the time of disclosure. In addition, after disclosure to the agency, the Contractor will promptly notify the agency of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the Contractor.

(d) Contractor action to protect the Government's interest in the event greater rights are granted to the Contractor.

(1) The Contractor agrees to execute or to have executed and promptly deliver to the NIH all instruments necessary to--(i) Establish or confirm the rights the Government has throughout the world in subject inventions pursuant to paragraph b.2. above, and (ii) Convey title to the NIH or to a Compound Supplier when requested under paragraph b.2. of this clause and to enable the NIH or a Compound Supplier to obtain patent protection throughout the world in that subject invention.

(2) The Contractor agrees to require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the Contractor each subject invention made under contract in order that the Contractor can comply with the disclosure provisions of paragraph (c) of this clause, and to execute all papers necessary to file patent applications on subject inventions and to establish the Government's rights or a Compound Supplier's rights in the subject inventions. This disclosure format should require, as a minimum, the information required by subparagraph (c)(1) of this clause. The Contractor shall instruct such employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars. The Contractor will notify the NIH of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceeding on a patent, in any country, not less than 30 days before the expiration of the response period required by the relevant patent office.

(3) The Contractor agrees to include, within the specification of any United States patent application it files and any patent issuing thereon covering a subject invention the following statement, "This invention was made with Government support under (identify the Contract) awarded by the National Institute of Allergy and Infectious Diseases. The Government has certain rights in the invention."

(4) The Contractor agrees to provide a final invention statement and certification prior to the close-out of the contract listing all subject inventions or stating that there were none.

(e) Subcontracts.

(1) The Contractor will include this clause, suitably modified to identify the parties, in all subcontracts, regardless of tier, for experimental, developmental, or research work. The subcontractor will retain all rights provided for the Contractor in this clause, and the Contractor will not, as part of the consideration for awarding the contract, obtain rights in the subcontractor's subject inventions.

(2) In the case of subcontracts, at any tier, NIH, the subcontractor, and the Contractor agree that the mutual obligations of the parties created by this clause constitute a contract between the subcontractor and NIH with respect to the matters covered by the clause; provided, however, that nothing in this paragraph is intended to confer any jurisdiction under the Contract Disputes Act in connection with proceedings under paragraph (c) (1) (ii) of FAR clause 52.227-13 which is incorporated by reference in paragraph b.3. of this clause.

(f) Reporting on utilization of subject inventions in the event greater rights are granted to the Contractor. The Contractor agrees to submit, on request, periodic reports no more frequently than annually on the utilization of a subject invention or on efforts at obtaining such utilization that are being made by the Contractor or its licensees or assignees when a request under subparagraph b.3. has been granted by the NIH. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the Contractor, and such other data and information as the agency may reasonably specify. The Contractor also agrees to provide additional reports as may be requested by the NIH in connection with any march-in proceeding undertaken by the NIH in accordance with paragraph (h) of this clause. As required by 35 U.S.C. 202(c)(5), the NIH agrees it will not disclose such information to persons outside the Government without permission of the Contractor.

(g) Preference for United States industry in the event greater rights are granted to the Contractor. Notwithstanding any other provision of this clause, the Contractor agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any subject invention in the United States unless such person agrees that any product embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the NIH upon a showing by the Contractor or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

(h) March-in rights in the event greater rights are granted to the Contractor. The Contractor agrees that, with respect to any subject invention in which it has acquired title through the exercise of the rights specified in subparagraph (b)(3), the NIH has the right in accordance with the procedures in FAR paragraph 27.304-1 and any supplemental regulations of the agency to require the Contractor, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the Contractor, assignee, or exclusive licensee refuses such a request the NIH has the right to grant such a license itself if the NIH determines that--

(l) Such action is necessary because the Contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use;

(2) Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the Contractor, assignee, or their licensees;

(3) Such action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the Contractor, assignee, or licensees; or

(4) Such action is necessary because the agreement required by paragraph (g) of this clause has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of such agreement.

(i) Special provisions for contracts with nonprofit organizations in the event greater rights are granted to the Contractor. If the Contractor is a nonprofit organization, it agrees that--

(1) Rights to a subject invention in the United States may not be assigned without the approval of the NIH, except where such assignment is made to an organization which has as one of its primary functions the management of inventions; provided, that such assignee will be subject to the same provisions as the Contractor;

(2) The Contractor will share royalties collected on a subject invention with the inventor, including Federal employee co-inventors (when the NIH deems it appropriate) when the subject invention is assigned in accordance with 35 U.S.C. 202(e);

(3) The balance of any royalties or income earned by the Contractor with respect to subject inventions, after payment of expenses (including payments to inventors) incidental to the administration of subject inventions will be utilized for the support of scientific research or education; and

(4) It will make efforts that are reasonable under the circumstances to attract licensees of subject inventions that are small business firms, and that it will give a preference to a small business firm when licensing a subject invention if the Contractor determines that the small business firm has plan or proposal for marketing the invention which, if executed, is equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business firms; provided, that the Contractor is also satisfied that the small business firm has the capability and resources to carry out its plan or proposal. The decision whether to give a preference in any specific case will be at the discretion of the contractor. However, the Contractor agrees that the Secretary of Commerce may review the Contractor's licensing program and decisions regarding small business applicants, and the Contractor will negotiate changes to its licensing policies, procedures, or practices with the Secretary of Commerce when the Secretary's review discloses that the Contractor could take reasonable steps to more effectively implement the requirements of this subparagraph.

(j) Communications. All invention disclosures and requests for greater rights shall be sent to the NIAID Contracting Officer. Additionally, a copy of all disclosures, confirmatory licenses to the Government, face page of the patent applications, waivers and other routine communications should be sent to Dr. George Stone, Office of Policy for Extramural Research Administration, Division of Extramural Invention and Technology Resources, National Institutes of Health, Rockledge, II, 6701 Rockledge Drive, Room 3190, MSC 7750, Bethesda, MD 20892-7750.

(End of clause)

FAR 52.227-14 Rights in Data-General (Deviation)
This clause deviation applies to data resulting from routine screening activities involving the use of proprietary compounds. Data resulting from research activities pertaining to the development of new screening assays or other activities involving the use of non-proprietary compounds will be covered by the standard rights in data clause (FAR 52.227-14, Rights in Data- General (June 1987)).

ADD THE FOLLOWING DEFINITION TO PARAGRAPH (a) OF THIS CLAUSE:

"Research compounds" as used in this clause means patented or unpatented products or compounds to be used for screening and testing as anti-viral, anti-bacterial, anti-fungal, anti-parasitic, immunomodulating, and biological modifying agents with potential for the treatment of viral diseases including HIV and associated infections.

MODIFY PARAGRAPH (d) OF THIS CLAUSE TO READ:

(d) Release, publication and use of data. (1) The Contractor shall have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, except to the extent such data may be subject to the Federal export control or national security laws or regulations. However, in order that information concerning possible inventions made under this contract is not prematurely published thereby adversely affecting the ability to obtain patent protection on such inventions, the Contractor will advise the NIAID Contracting Officer of any proposed publications or public disclosures relating to the work performed under this contract. Upon the NIAID Contracting Officer’s request the Contractor agrees to delay the public disclosure of such data or publication of a specified paper for a reasonable time specified by the Contracting Officer, not to exceed 6 months, to allow for the filing of domestic and international patent applications in accordance with Clause 52.227-11, Patent Rights (Deviation).

ADD THE FOLLOWING PARAGRAPH (j) TO THIS CLAUSE:

(j) Research products or compounds. The Contractor agrees that in accordance with paragraph (d)(2) proprietary information on research products or compounds, patented or unpatented, provided through this contract shall be used only for screening and testing as anti-viral, anti-bacterial, anti-fungal, anti-parasitic, immunomodulating, and biological modifying agents with potential for the treatment of viral diseases including HIV and associated infections and for no other purpose.

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Request for Proposal No.:	NIH-NIAID-DAIDS-99-16
Issue Date:	September 8, 1998
Issued By:	Ross Kelley, Contract Specialist AIDS Research Contract Section, NIAID, NIH Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard, MSC 7610 Bethesda, Maryland 20892-7610
Point of Contact:	Ross Kelley, Contract Specialist
Purchase Authority:	Public Law 92-218 as amended
Small Business Set-Aside:	No, SIC Code 8733
Just In Time:	No
Offer Expiration Date:	Offers will be valid for 120 days unless a different period is specified by the Offeror on the form entitled "Proposal Summary and Data Record, NIH 2043."
Proposal Due Date:	November 30, 1998, 4:00 P.M EST