RFP-NIH-NIAID-DAIDS-99-05

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the requirements of this RFP (NIH-NIAID-DAIDS-99-05) entitled "Tuberculosis Drug Development: Tuberculosis Anti-microbial Acquisition and Coordinating Facility." 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:

1. Introduction, Background and Work Statement, dated August 6, 1998
   A.1 Screening Agreement for Submitting Products to the Division of AIDS (SAMPLE), dated August 6, 1998
2. Reporting Requirements and Deliverables, dated August 6, 1998
3. Evaluation Factors for Award, dated August 6, 1998
4. Specific RFP Instructions and Provisions, dated August 6, 1998
5. Applicable RFP References, dated August 6, 1998
6. Proposed Deviation of FAR Clauses FAR 52.227-14 and FAR 52.227-11 After a Determination of Exceptional Circumstances and Revised Clauses, dated August 6, 1998

In addition to the information provided in this document (i.e., The Streamlined RFP), there are five (5) 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 Joyce Sagami, 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 Joyce Sagami, 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 13, 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 13, 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 Joyce Sagami, Contract Specialist, at the Internet electronic mail address js73b@nih.gov, or by fax at 301/402-0972. Ms. Sagami can be reached at 301/496-7118. 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

RFP-NIH-NIAID-DAIDS-99-05
August 6, 1998

INTRODUCTION, BACKGROUND AND WORK STATEMENT

The purpose of this contract is to serve as the central facility for coordinating acquisition and testing of novel compounds. 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 Contractor's efforts by the Project Officer will be necessary.

In order to facilitate the development of improved drugs for the treatment of tuberculosis, and particularly multi-drug resistant tuberculosis, the NIAID supports the directed acquisition and evaluation of selected novel synthetic and pure natural product compounds as potential tuberculosis anti-microbials. 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. At the present time, NIAID has a tuberculosis anti-microbial Acquisition and Coordinating Facility Contract, which is scheduled to end on September 14, 1999. The current Contractor is:

Two other contracts are being competed (RFP NIH-NIAID-DAIDS-99-16 and RFP NIH-NIAID-DAIDS-99-15) which will provide the laboratory facilities for microbiological tuberculosis screening and animal efficacy testing, respectively.

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. Acquire Approximately 4,000 Compounds Per Year for Screening against M. Tuberculosis

1. After consultation with and approval by the Project Officer, selectively acquire synthetic and pure natural product compounds as potential anti-tuberculosis agents from a wide variety of sources and within a wide variety of chemical classes. These are anticipated to consist principally of synthetic compounds or libraries of compounds, although acquisition of pure natural compounds is encouraged. The structures of these compounds shall be verified as new to the National Institute of Allergy and Infectious Diseases (NIAID) tuberculosis chemical database and shall represent at least 10 mg each of compounds available for testing.
2. Initiate and develop liaisons and maintain communication with sources of compounds; provide guidance to suppliers for selection of compounds for testing; present and explain the standard DAIDS "Screening Agreement for Submitting Products to the Division of AIDS" to prospective suppliers. (See Attachment A.1.)
3. Ensure that any identifiable data on the compounds or products and/or the testing results will be safeguarded for confidentiality 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.
4. The Contractor shall explain to prospective suppliers that the Government shall have the right to explore further testing of compounds in consultation with the Contractor and the supplier. In addition, the Government shall have a royalty-free, irrevocable, non-transferable, paid-up license for clinical trials research under any patent on the compound or on a process for use of such compound, to manufacture and/or use by or for the Government the invention claimed by the patent. This license will apply only to medical research purposes related to or connected with the treatment of AIDS and associated infections including tuberculosis.

5. Plan and coordinate compound collection trips. If required, the Contractor shall weigh and aliquot samples at suppliers' facilities.

6. Conduct, organize, and maintain correspondence with compound suppliers. (See also Work Statement Item #7.)

2. Maintain Computerized Inventory and Chemical Database Management Systems.

1. Maintain an accurate, on-going computerized inventory of compounds and amounts available for testing.
2. Maintain a chemical database at the Contractor's site using chemical structures software capable of storing and performing substructure searching between 25,000 and 50,000 structures and capable of transparent integration with and updating of the NIAID Tuberculosis Chemical Database.
3. Enter all acquired chemical structures into the database and quality assure the accuracy of entry. Verify that all structures accepted for testing are new to the NIAID Tuberculosis Chemical Database. Provide updates of all structures acquired and submitted for testing to the Project Officer as computer files.

4. Coordinate integration of data from microbiology testing laboratories into the chemical database. The Contractor will be responsible for efficient and accurate transfer of digitized information into the Contractor's database and ultimate transfer to the NIAID database.
5. Coordinate the efficient and accurate reporting of information to the Project Officer.

6. Mark all data and compound information as 'Proprietary, Confidential' and maintain the confidentiality of and provide security for all data, particularly chemical structures.
7. Provide monthly updates of chemical and microbiological data to the Project Officer.
8. Survey the published literature through scientific journals, Internet search engines, computerized summaries such as MEDLARS from the National Library of Medicine, Index Chemicus® published by the Institute for Scientific Information, Inc., Philadelphia, PA, patent searches, and other sources for compounds with potential for activity against M. tuberculosis. Abstract chemical and biological information from these sources into the database.

3. Coordinate Distribution of Compounds for Biological Evaluations.

1. Coordinate the shipment of compounds (under a labeling code as determined by the Contractor) for microbiological testing to the Contractor performing microbiological tuberculosis screening, and to other testing sites identified by the Project Officer. Provide information on compounds (with documents on solubility, stability, and safety) to the testing facilities. Weigh, prepare, and ship compounds for biological evaluation to the testing laboratories.

2. Provide quality control evaluations of the microbiological screening procedures, using periodic submission of known active compounds under a labeling code.
3. Acquire additional quantities of active compounds for confirmatory and secondary in vitro and in vivo evaluations as authorized by the Project Officer. This activity involves the gathering of facts related to the reacquisition, consultation with Project Officer, and initiating the correspondence to achieve the reacquisition. This responsibility includes tracking of attempts through to the successful reacquisition or until the decision is made to terminate the request by the Project Officer. Notations related to this task shall be included in the NIAID chemical database.

4. Provide Secure and Safe Facilities and Resources:

1. Provide facilities for computer operation, data entry, and file storage which are secure from unauthorized access. The Contractor's facility shall be protected by a security alarm system.
2. Provide protective garments, equipment and sufficient monitoring to assure safe handling of potentially hazardous materials. Specifically, the Contractor shall comply with all applicable safety and health regulations (Federal, State and local) while conducting the work set forth herein.
3. Provide appropriate computer software and guidance to the Contractor performing Microbiological Tuberculosis Screening for the efficient entry of microbiological data into compatible computer files. Update the database at the TB Anti-microbial Acquisition and Coordinating Facility with information from the Microbiological Screening facility.
4. Only those Contractor employees or Government employees directly engaged in this project shall 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.

[NOTE 7 TO OFFEROR: The offeror shall provide in the Technical Proposal the floor plan of the proposed facility and list equipment and resources to be dedicated to the project. The offeror shall include security, safety, and health plans in the Technical Proposal and a summary of the offeror's safety and health operating procedures manual.]

5. Receive and Ship Compounds:

1. Obtain the appropriate licenses and permits required by Federal, State and local authorities for the safe transport, storage, and distribution of compounds.
2. Maintain stability of all shipments received by providing the appropriate temperature control in transit from the airport or other site to the Contractor; provide resources, if necessary, for shipping costs from the suppliers to the contract site.
3. Provide for safe packaging, labeling, and shipping of compounds to biological evaluation sites approved by the Project Officer so that such shipments are coordinated for timely receipt.
4. Use shipping containers for compounds which will comply with domestic and international postal regulations and pertinent International Air Transport Association/International Civil Aviation Organization regulations. The shipping containers shall provide a sufficient margin of safety for maintaining appropriate environmental safeguards and desired refrigeration levels for specific products in transit, depending on the mode of transportation employed.

6. Provide Monthly Computer Updates and Reports and Meet with the Project Officer.

1. Report data generated under this contract to the Project Officer in the form of monthly computer updates and 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.

2. 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.

3. At least one of the Contractor's key personnel shall 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.

7. Maintain and coordinate correspondence with suppliers and testing laboratories.

1. The Contractor shall coordinate direct correspondence with suppliers relating to compound acquisition, explanation and execution of confidentiality agreements, and reporting of testing results.
2. At the direction of the Project Officer, the Contractor shall develop and provide computer-based data-reporting forms, form letters from the Government explaining the test results, and other correspondence forms.
3. The Contractor shall organize and maintain files of correspondence and all other information pertaining to compound submission and testing and shall devise and maintain efficient record retrieval systems at the Contractor's site.

8. 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 a plan for an orderly transition of data and samples to a subsequent Contractor or to the Government, subject to Project Officer approval, and shall deliver, by a date specified by the Project Officer within 6 months of the completion date of the contract, the following items: (1) preserved compounds; (2) computerized listing of and updated information on compound inventory, including activities of the contract, data files, database, original data, and any necessary information related thereto; (3) project-related labeled and inventoried paper files; and any Government-owned property, if applicable.

RFP-NIH-NIAID-DAIDS-99-05
August 6, 1998

(SAMPLE)

Screening Agreement for Submitting Products to the Division of AIDS

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.

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

1. A cover page containing:

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

2. A table of contents indicating page number for each major section.
3. Summary of all compounds acquired and test results obtained during the quarter (Number, supplier, structure, chemical class, activity).
4. Cumulative summary of all compounds acquired and test results obtained under the contract.
5. Summary of current technical or administrative problems encountered, their resolution or the proposed corrective action.

1. 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;
2. Remaining, appropriately preserved compounds;
3. Labeled and inventoried paper files;
4. Any other government-owned property;
5. The transition plan required in Item #8 of the Work Statement;
6. One complete copy of the final, updated and verified Tuberculosis Database as a computer file;
7. A written assurance from the authorized institutional official that all files containing data relating to this contract have either been transferred or destroyed.

E. Technical Reports Distribution

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 therefore.

1. GENERAL

2. MANDATORY QUALIFICATION CRITERION

The following qualification criterion establishes conditions that MUST be met at the time of proposal submission in order for proposals to be considered for award:

3. 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.

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 ."

1. 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.

2. 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 3,920%, (560% 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	10%	70%
Chemists/Data Coordinators	200%	1,400%
Technicians	200%	1,400%
Data Clerks	150%	1,050%
TOTAL	560%	3,920%

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

3. 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:

1. The standard industrial classifications (SIC) code for this acquisition is 8731.

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

(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 500 employees.

2. 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.
4. SERVICE OF PROTEST (AUG 1996) - 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 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.

2. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.
5. 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-99-05
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.

1. 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

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

If using U.S. Postal Service

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

2. 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).

6. 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.)

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

(a)  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).

(b)  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.  

(c)  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.

(d)  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.

(e)  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.

8. PROPOSAL INTENT RESPONSE SHEET

RFP No.: NIH-NIAID-DAIDS-99-05

RFP Title: "Tuberculosis Drug Development: Tuberculosis Anti-microbial Acquisition and Coordinating Facility."

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.

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[ ] DO INTEND TO SUBMIT A PROPOSAL

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

---------------------------------------------------------------------------------------------

---------------------------------------------------------------------------------------------

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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)

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RETURN TO:

CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Attn: Joyce Sagami
RFP-NIH-NIAID-DAIDS-99-05
FAX# 301/402-0972

Email js73b@nih.gov

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9. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT

ATTACHMENT E

APPLICABLE RFP REFERENCES

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

1. 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".
2. 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)

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

• Technical Proposal Cover Sheet
• Technical Proposal Cost Information
• Summary of Current and Proposed Activities

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

• 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.

• Certificate of Current Cost or Pricing Data, NIH-1397

3. The "Representations and Certifications" are applicable.
4. 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" which shall be used for all suppliers.

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)

(a) Definitions.

(b) Allocation of principal rights.

(c) Invention disclosure by Contractor.

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

(e) Subcontracts.

(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--

(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--

(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)

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:

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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