Request for Proposal No.: |
NIH-NIAID-DAIDS-99-05 |
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Issue Date: |
August 12, 1998 |
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Issued By: |
Joyce Sagami, Contract Specialist |
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Point of Contact: |
Joyce Sagami, Contract Specialist |
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Purchase Authority: |
Public Law 92-218 as amended |
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Small Business Set-Aside: |
No, SIC Code 8731 |
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Just In Time: |
No |
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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." |
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Proposal Due Date: |
November 13, 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-99-05) 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:
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
ATTACHMENT A
RFP-NIH-NIAID-DAIDS-99-05
August 6, 1998
INTRODUCTION, BACKGROUND AND WORK STATEMENT
RESTRICTIONS TO COMPETITION
This contract will involve the use of information on compounds, which may be confidential and proprietary. All offerors except those deemed by the Government to have an actual or apparent conflict of interest are eligible to compete. Organizations that are, or subsidiaries to, pharmaceutical or chemical companies (i.e., an organization which sells drugs and/or chemicals to the general public for profit) are examples of organizations that are excluded from competition. Documentation of commercial interests, such as investors' prospectus or recent audit, shall be supplied in an offeror's business proposal. The Government reserves the right to exclude any offeror that falls within the above-stated criteria. If there is ANY question about potential conflicts or APPARENT conflicts contact the Contracting Officer.
An Advance Understanding will be inserted in the resultant contract stating that the National Institute of Allergy and Infectious Diseases (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.
INTRODUCTION AND BACKGROUND
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:
Southern Research Institute
Tuberculosis Anti-microbial and Coordination Facility
N01-AI-45246
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.
Work Statement - Tuberculosis Anti-microbial Acquisition and Coordinating Facility
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.
[GENERAL NOTE TO OFFEROR: In responding to this RFP, offerors shall 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 shall provide necessary facilities, including all major equipment, and capabilities to perform all the functions of the Work Statement and to safeguard confidential and proprietary data.
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 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 compounds and Government-owned property under this contract shall be in accordance with all applicable Federal, State and local regulations including safety and health standards. (See Safety and Health Deviation, Item #7. of Attachment D., Specific RFP Instructions and Provisions of the RFP.)]
Specifically, the Contractor shall:
1. Acquire Approximately 4,000 Compounds Per Year for Screening against M. Tuberculosis
[NOTE 1 TO OFFEROR: The process of identifying promising classes of compounds to pursue for acquisition is an evolving science requiring experienced medicinal chemists. Offerors shall provide, in the professional staffing plan, appropriately qualified chemists holding advanced degrees in medicinal chemistry and with experience in drug development. The variety and quality of compounds acquired will be closely monitored by the Project Officer.
Offerors shall submit plans for compound acquisition from both commercial and academic sources at the rate of approximately 4,000 synthetic and pure natural product compounds per year. A detailed plan for identifying, prioritizing, and acquiring classes of compounds shall be submitted as part of the Technical Proposal. Individual compounds will be acquired gratis from the suppliers, will be selected for tuberculosis screening by the suppliers, and will be verified as new to the NIAID database by the Contractor. Offerors shall discuss in detail their approach to safeguarding the rights of the suppliers in arrangements for the potential commercialization of discoveries made as a result of any awarded contract. 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.]
[NOTE 2 TO OFFEROR: The technical approach to compound acquisition shall include a cost effective plan for interaction with potential suppliers. Although the majority of interactions are anticipated to be through telephone contacts and correspondence, it is recognized that visits by the Contractor's personnel is a highly productive method for acquisition efforts. For the purpose of preparing a cost proposal, assume that 2 trips per month will be required to supplier sites within the contiguous United States.]
2. Maintain Computerized Inventory and Chemical Database Management Systems.
[NOTE 3 TO OFFEROR: The NIAID Tuberculosis Chemical Database is maintained by the NIAID in Rockville, Maryland, on an IBM RS/6000 operating in an AIX environment using ISISTM/Host software, Molecular Design Limited, San Leandro, CA, in a relational database format with ORACLETM RDBMS Ver. 7.0 software, Oracle Corporation, Redwood Shores, CA. The Contractor will be provided with a confidential copy of the NIAID Tuberculosis Database in ISISTM format and will append compounds and biological data acquired under this contract to the database. All data will be submitted to the Project Officer on magnetic media as monthly reports in formats compatible with the NIAID database and with instructions for automatic updating. In the Technical Proposal, please list existing computer hardware and software resources available to this project, and state whether these are year 2000 compliant or if there are any efforts underway to provide this capability.]
[NOTE 4 TO OFFEROR: Offerors shall propose a plan for efficient, accurate, and secure transfer of data. Offerors shall address plans for ensuring the accuracy of updated data.]
3. Coordinate Distribution of Compounds for Biological Evaluations.
[NOTE 5 TO OFFEROR: The shipping rate of compounds to testing laboratories shall be approximately 330 per month or a rate agreed upon by the Contractor, the Project Officer, and the microbiological tuberculosis screening laboratory so as to provide a steady supply to accommodate the work load of the testing laboratories. For purposes of preparing a cost proposal, offerors shall assume that the primary screening laboratory is located in Rockville, Maryland, and that 330 compounds per month will be shipped to the primary screening laboratory. These shipments are anticipated to be standardized, 10 mg aliquots in clear glass containers. Offerors shall further assume that approximately 50 compounds per year will be reacquired from the original supplier and will be shipped in gram amounts to an animal testing laboratory located on the West coast of the United States. (Assume San Francisco, California, for this estimate).]
[NOTE 6 TO OFFEROR: Reacquisition, i.e. the acquisition of samples previously tested for which larger quantities are needed for secondary evaluation, is an important aspect of this project. Sample sizes of 50 to 100 mg or more of synthetics and 25 mg of pure natural products are anticipated for confirmatory in vitro tests; gram quantities will be required for in vivo evaluations.
The offeror shall describe a plan for verifying the identity and purity of the re-acquired compounds, and shall describe assays to be used. The Contractor may subcontract for the performance of assays and evaluation of compounds, if necessary.]
4. Provide Secure and Safe Facilities and Resources:
[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:
[NOTE 8 TO OFFEROR: For the purposes of preparing a cost proposal, assume approximately 30 shipments per year will be made from the Contractor's site to the Microbiological Screening Contractor. (Assume Rockville, Maryland, for this estimate.) Further assume that shipping costs from 10 suppliers to the Contractor's site will be required per year. The offeror shall describe a plan for how compounds will be delivered in a timely and safe manner. The offeror shall establish a mechanism for prompt notification of the Project Officer of the dates compounds were shipped and received by the Microbiological Screening Contractor. The offeror shall include details of a proposed notification mechanism and plan in the Technical Proposal.]
6. Provide Monthly Computer Updates and Reports and Meet with the Project Officer.
[NOTE 9 TO OFFEROR: The offeror shall propose a plan for efficient data management and retrieval, as well as for electronic digital communication (including the ability to transmit electronic mail) with the NIAID computer network system. The Government will not authorize purchase of stand-alone computers under this contract for the purpose of Project Officer communications. NIAID is connected to the Internet and uses IBM-compatible computer hardware for data management and communication. The offeror shall supply an IBM-compatible computer, be able to communicate and supply information in an IBM-compatible format and shall submit electronic documents in Microsoft WordTM version 7.0 for Windows and Microsoft ExcelTM version 7.0 for Windows. For the purpose of preparing a cost proposal, the offeror shall assume that monthly reports will be submitted, each containing one table of identifiers and data. The offeror shall also estimate costs for quarterly and final reports. Guidelines for preparing reports are in Attachment B, Reporting Requirements and Deliverables.]
[NOTE 10 TO OFFEROR: For the purpose of preparing a cost proposal, assume 2 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.]
7. Maintain and coordinate correspondence with suppliers and testing laboratories.
[NOTE 11 TO OFFEROR: An Advance Understanding will be inserted in any resultant contract, stating that (1) 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) and (2) 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 (Attachment A.1).]
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.
ATTACHMENT A.1
RFP-NIH-NIAID-DAIDS-99-05
August 6, 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:
a. 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.
b. 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.
c. 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.
d. 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.
a. 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.
b. The DIVISION and SUPPLIER agree that publication of screening results is worthwhile and should be governed by the following: Specifically:
(1) 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.
(2) 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).
(3) 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.
c. 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 |
Name(Signature) |
NIAID, NIH |
____________________________ |
______________ |
____________________________ |
Date |
Company |
RFP-NIH-NIAID-DAIDS-99-05
August 6, 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 this contract and the Microbiological Tuberculosis Screens testing laboratory. Therefore, reporting requirements will include reports to be exchanged between the contracts as well as Project Officers. The following represent the minimum requirements:
1. The Contractor shall submit packing lists with each shipment to the Microbiological Tuberculosis Screens testing laboratory. In addition, a shipping summary shall be submitted to the Microbiological Tuberculosis Screens testing laboratory and the Project Officer every calendar month. This summary will include details of all shipments during the previous calendar month such as the shipment number, compound code identifiers, quantity of compound shipped, color of compound, and date of shipment. This report shall be submitted as digital computer files on a 3.5 inch high density diskette or other digital medium to the testing laboratory designated by the Project Officer and to the Project Officer by the fifteenth calendar day of each month. The computer files shall be compatible with the NIAID Tuberculosis Database software (ISISTM/Base) and appropriate licensing or software purchases shall be provided by the Contractor for use at the testing laboratory.
2. The Contractor shall submit, to the Project Officer only, monthly updates to the NIAID Tuberculosis Database (chemical and microbiological information), a listing of all compounds acquired during the month, and a listing of all contacts with potential suppliers as one paper copy and as digital computer files on 3.5 inch high density diskettes, or through other digital media specified by the Project Officer.
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 2 copies on magnetic media as computer files in Microsoft WordTM version 7.0 for Windows for text and ExcelTM version 7.0 for Windows for tables and ISISTM/Base format readable using an IBM-type personal computer. It remains the responsibility of the Contractor to assure receipt by the indicated government officials 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 shall be submitted in addition to monthly reports.
Each quarterly report shall consist of:
(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.
C. Final Report
The Contractor shall submit 4 paper copies of the final report which document and summarize the results of the entire contract for the period of performance AND as 2 copies on magnetic media as computer files in Microsoft WordTM version 7.0 for Windows for text and ExcelTM version 7.0 for Windows for tables format readable using an IBM-type personal computer. 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).
E. Technical Reports Distribution
Type of |
No. of |
Addressee/Distribution |
Due Dates |
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Quarterly |
1* |
Project Officer, OIRB, TRP |
Quarterly |
Quarterly |
Original* |
Contracting Officer, ARCS |
Quarterly |
Monthly |
1* |
Same as Project Officer above. |
Monthly |
Monthly |
1* |
Contractor site to be identified. |
Monthly |
Final |
3* |
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 therefore.
RFP-NIH-NIAID-DAIDS-99-05
August 6, 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 of proposal submission in order for proposals to be considered for award:
The offeror must successfully demonstrate to the Government, through the submission of documentation of the offeror's commercial interests (such as an investors' prospectus or audit report) that the offeror has no conflict of interest or APPARENT conflict of interest that may arise from the use of information on compounds (to be provided under this contract) which may be confidential or proprietary.
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.
1. Technical Approach (50 points)
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 |
o Extent of understanding of the proposed tuberculosis project;
o Adequacy of understanding of the drug development process;
o Quality of the plan for identification, acquisition, and prioritization of potential drugs;
o Appreciation of confidential and proprietary information.
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(b)Adequacy of plans for compound acquisition and testing |
15 points |
o Development of resources, skills, and techniques for compound and structure acquisition, and the approach for obtaining a maximum number and diversity of compounds, structures, and related data;
o Maintenance of an uninterrupted flow of materials to the testing laboratories for in vitro and in vivo evaluations;
o Coordination of anti-microbial testing and quality control;
o Literature surveillance and appropriateness of journals and abstract services to be monitored for compounds.
|
(c)Adequacy of plans for data management |
10 points |
o Approach to computer database organization and maintenance;
o Approach to efficient management of correspondence, documentation of samples, and test results.
2. Personnel Qualifications/Organizational Experience (40 points)
(a)Principal Investigator |
15 points |
The principal investigator shall have a Ph.D. or equivalent degree or level of experience in relevant scientific disciplines such as medicinal chemistry or organic chemistry.
o Relevance and quality of recent work;
o Documented experience with technical approaches proposed;
o Documented availability for the proposed project;
o Documented experience with managing projects of similar complexity.
(b)Other personnel/staffing plan/organizational experience |
25 points |
The professional staff shall have advanced academic degrees or equivalent levels of experience in relevant scientific disciplines such as medicinal chemistry and organic chemistry;
o Relevant experience of other professional and technical staff and their documented capability to conduct proposed activities utilizing appropriate computer skills;
o Documented experience in medicinal chemistry on similar projects involving selection of potentially active compounds;
o Adequacy of the staffing plan, including clear lines of authority, and the time commitment of the technical staff for the conduct of the project.
o Adequacy and suitability of the organization's experience and qualifications performing comparable work as evidenced by the ability to maintain industrial liaisons, compound collection, and chemical data management without potential conflict of interest situations arising.
o Adequacy of plans for compliance with all safety guidelines and regulations, including training and monitoring of personnel for exposure to hazardous reagents and safe disposal of such reagents.
3. Facilities and Resources (10 points)
(a) Documented availability of adequate facilities (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 MUST be provided.
(b) Documentation of facilities to receive and store compounds, and maintain their stability.
TOTAL: |
100 points |
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|
RFP-NIH-NIAID-DAIDS-99-05
August 6, 1998
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 ."
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.
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 |
---|---|---|
|
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.
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 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.
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.
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.
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
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).
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.)
(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.
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.
[ ] 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)
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
(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.) |
|
a. STATEMENT OF WORK
|
Page 4 |
|
b. PERSONNEL (List by name, title, department and organization, and detail each person's qualifications and role in the Project. Provide narrative.)
(Note: For key personnel, include 2-page biosketch/resume and the form entitled "Summary of Current and Proposed Activities.") |
Page _ |
|
c. 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 _ |
|
d.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. |
RFP-NIH-NIAID-DAIDS-99-05
August 6, 1998
This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.
Note: A Subcontracting Plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due.
ATTACHMENT F
RFP-NIH-NIAID-DAIDS-99-05
August 6, 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.
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.
(c) Invention disclosure by Contractor.
(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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