MAA/RFP No. NIH-NIAID-DAIDS-96-17 Title: "MASTER AGREEMENT FOR HIV PRECLINICAL VACCINE DEVELOPMENT" Issued by: Kristi Cooper Contract Specialist NIH/NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20982-7610 DATE ISSUED: October 26, 1995 PROPOSAL DATE DUE: December 19, 1995, 4:00 P.M. (EST) Ladies and Gentlemen: You are invited to submit a proposal(s) in accordance with the requirements of the attached MAA/RFP No. NIH-NIAID-DAIDS-96-17. The Division of AIDS is required to seek new sources for this Master Agreement Program annually. This MAA/RFP is being issued to establish additional sources (Master Agreement Holders) capable of conducting preclinical vaccine development through Master Agreement Orders (MAO's). Awards resulting from this Master Agreement Announcement will establish an organization's qualification and ability to compete for the performance of various work categories related to preclinical vaccine development. It is anticipated that multiple Master Agreement awards will result from this MAA/RFP, and that awards will be made in the Spring of 1996, and will be valid for a period of three years. No legal liability on the part of the Government for repayment of any money shall arise as a result of any Master Agreements awarded hereunder. PLEASE NOTE THAT AT THIS TIME BUDGETS ARE NOT REQUIRED. THE MAA/RFP MECHANISM IS FOR THE PURPOSE OF PREQUALIFYING OFFERORS BASED ON TECHNICAL MERIT ALONE. ALL ORGANIZATIONS SUBMITTING PROPOSALS RATED "ACCEPTABLE" WILL BE ADDED TO THE APPROPRIATE MASTER AGREEMENT (MA) POOL(S). AT THE TIME DEFINITIVE REQUIREMENTS ARISE, ALL THOSE WHO HAVE BEEN AWARDED MASTER AGREEMENTS WILL BE ISSUED MAO/RFP's (MASTER AGREEMENT ORDER/REQUEST FOR PROPOSALS). BUDGETS WILL BE REQUIRED AT THAT TIME. NOTE: CURRENT MA HOLDERS FOR THIS PROGRAM ARE NOT REQUIRED TO SUBMIT A PROPOSAL. OFFERORS ARE NOW ONLY RESPONSIBLE FOR RESPONDING TO THE STATEMENT OF WORK FOR THE PARTICULAR MA CATEGORIES IN WHICH THEY ARE INTERESTED. OFFERORS ARE NOT REQUIRED TO RESPOND TO THE "SAMPLE" MAO'S FOR THE VARIOUS WORK CATEGORIES; THESE ARE FOR INFORMATIONAL PURPOSES ONLY. Listed below are the four attachments to this electronic RFP package. These documents represent all the necessary information required for the submission of a proposal for this acquisition. NOTE: The Representations and Certifications must be submitted with the offeror's proposal. (This form can be found under NIH Gopher directory entitled "Instructions for Proposal Submission," subdirectory "Forms Required for Proposal Submission.") Although these documents contain sufficient information for proposal submission, if you or your organization intend to submit a proposal in response to this RFP, IT IS ESSENTIAL THAT YOU IMMEDIATELY NOTIFY KRISTI COOPER OF THE NIAID CONTRACTING OFFICE AT THE FOLLOWING INTERNET ADDRESS: kh22k@nih.gov IF YOU DO NOT NOTIFY THE NIAID CONTRACTING OFFICE OF YOUR INTENT TO SUBMIT A PROPOSAL(S), YOU WILL NOT RECEIVE AMENDMENTS TO THE RFP WHICH MAY AFFECT YOUR PROPOSAL PREPARATION. The documents included with this electronic RFP package are as follows: 1. Introduction, Background and Work Statements, dated October 26, 1995 (Attachment 1). 2. Evaluation Factors for Award, dated October 26, 1995 (Attachment 2). 3. Instructions, Conditions, Notices to Offerors, and Forms, dated October 26, 1995 (Attachment 3) 4. Advance Understanding - "Proprietary Data Confidentiality", October 26, 1995 (Attachment 4) In addition to the information listed above, a listing of the applicable Government clauses/provisions, sample contract format, and terms and conditions which will be incorporated into the eventual contract document may be obtained either through accessing the NIH Gopher system or by sending a request to Kristi Cooper, Contract Specialist, using the internet electronic mail address listed above. Instructions for delivery of proposals are detailed in Attachment 3, item 7. PLEASE READ THIS ITEM VERY CAREFULLY. The original and 2 copies of your technical proposal and the original and 2 copies of your business proposal must be received by the Contracting Officer no later than December 19, at 4:00 p.m. local time at the address listed in Attachment D, Item 7. PLEASE NOTE THAT THE CONTRACTING OFFICE IS THE OFFICIAL ADDRESS FOR RECEIPT OF YOUR TIMELY PROPOSAL. You are reminded that the "Technical Proposal Cover Sheet" (See NIH Gopher subdirectory entitled "Forms Required for Proposal Submission.") must be completed in full detail and used as the cover sheet for each copy of your technical proposal. New policies require submission of more detailed information than has been previously required. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, and 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 technical review committee members. Your attention is further directed to the "Proposal Intent" form contained in the NIH Gopher sub-directory entitled "Forms Required for Proposal Submission." Please complete this form and return it to this office on or before November 20, 1995. Questions concerning any areas of uncertainty which in your opinion require clarification or correction, must be furnished in writing to the Contracting Officer. Your questions should be received on or before November 9, 1995 at the address indicated in Attachment 3, item 7 (fax or e-mail is also acceptable) and marked "Offeror's Questions, RFP-NIH-NIAID-DAIDS-96-17." Funds are not obligated with Master Agreement awards. The Government's obligation under a resulting MAO is contingent upon availability of appropriated funds from which payment for contract purposes can be made. Please note that in addition to the telephone and fax numbers, the INTERNET addresses of the Principal Investigator and the responsible business representative are to be included in the form NIH 2043, "Proposal Summary and Data Record", contained in the NIH Gopher sub-directory entitled "Forms Required for Proposal Submission." If you have any questions regarding this RFP, please contact Kristi Cooper through the internet using the electronic mail address listed above, or by phone 301/496-7288, or fax 301/402-0972. Sincerely, \s\ Toni A. Kuhn Chief, APRCS Contract Management Branch National Institute of Allergy and Infectious Diseases, NIH Attachments: 1-4 ******************************************************************* ******************************************************************* MASTER AGREEMENT ANNOUNCEMENT/RFP 96-17 ATTACHMENT 1: STATEMENT OF WORK OCTOBER 26, 1995 TABLE OF CONTENTS INTRODUCTION AND BACKGROUND GENERAL NOTE TO OFFERORS CATEGORY A: PRODUCTION OF CLINICAL GRADE (GMP or GLP-Produced) VACCINES Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY B: EVALUATION OF AIDS VACCINES IN NON-HUMAN PRIMATE MODELS Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY C: THE USE OF SEVERE COMBINED IMMUNODEFICIENT (SCID) MICE TO ASSESS VACCINE RESPONSES Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY D: THE USE OF OTHER ANIMAL MODELS** FOR AIDS VACCINE DEVELOPMENT Statement of Work for MA Technical Evaluation Criteria for MA **Other than non-human primates or immunodeficient mice CATEGORY E: DETECTION OF ANTIBODIES AND PROTEINS; ISOLATION AND PRODUCTION OF VIRUS Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY F: PRODUCTION AND PURIFICATION OF VIRAL OR CELLULAR PROTEINS Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY G: ASSESSMENT OF HUMORAL IMMUNE RESPONSES Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY H: PRODUCTION OF HUMAN MONOCLONAL ANTIBODIES Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY I: ASSESSMENT OF CELLULAR IMMUNE RESPONSES Statement of Work for MA Technical Evaluation Criteria for MA CATEGORY J: MOLECULAR BIOLOGY SUPPORT FOR DEVELOPMENT AND ASSESSMENT OF VACCINES Statement of Work for MA Technical Evaluation Criteria for MA SAMPLE MAOs AND SAMPLE MAO TECHNICAL EVALUATION CRITERIA ARE PROVIDED IN A SEPARATE DIRECTORY; THESE SAMPLES ARE FOR INFORMATIONAL PURPOSES ONLY AS EXAMPLES OF FUTURE MAO REQUIREMENTS. ********************************* PLEASE NOTE: YOU MAY SUBMIT PROPOSALS FOR ONLY ONE (1) OR UP TO TEN (10) WORK CATEGORIES; HOWEVER, IF YOU ELECT TO SUBMIT FOR MORE THAN ONE WORK CATEGORY, YOU MUST SUBMIT SEPARATE AND COMPLETE TECHNICAL AND BUSINESS PROPOSALS FOR EACH, FOLLOWING THE INSTRUCTIONS CONTAINED IN THE MAA/RFP. ****************************************************************** STATEMENT OF WORK INTRODUCTION The objective of the Master Agreement Program is to enhance the NIAID's ability to move quickly into expeditious development of promising AIDS vaccines. This program will provide a flexible resource which can support a variety of tasks in preclinical development and laboratory analyses of the most promising HIV vaccine candidates. BACKGROUND Progress in HIV vaccine research over the last few years has led to the development of several vaccine strategies and candidate vaccines. Phase I clinical trials are being conducted on several prototype, first generation vaccines. Despite this progress, however, there are several complex problems, such as the ability of a vaccine to generate an immune response which blocks infection by all the HIV isolates in a population, the generation of a long- lasting protective immune response, and the determination of the characteristics of a protective immune response, which still remain to be solved before the goal of an effective, safe AIDS vaccine is achieved. New approaches, combined strategies, and faster development of ongoing research will all be needed to accelerate the progress toward successful HIV vaccine development. The establishment of this Master Agreement Program and the subsequent award of Master Agreement Orders (contracts), will make it possible for the NIAID to respond rapidly and efficiently with resources to accelerate the development of promising vaccine approaches. This program will complement NIAID-supported basic research studies and vaccine evaluation studies being funded through investigator-initiated research grants, National Cooperative Vaccine Development Groups (NCVDGs), AIDS Vaccine Evaluation Units (AVEUs), SIV Vaccine Evaluation Units, other vaccine support contracts, and commercial small business innovative research grants in AIDS vaccine development. It will increase the efficiency and coordination of the NIAID-sponsored AIDS vaccine program and will provide the NIAID with an effective balance between basic and applied research to accelerate efforts aimed at development and licensing of safe and effective AIDS vaccines. The Master Agreement (MA) is a mechanism which provides the flexibility and capability to respond rapidly to changing needs and new developments in pre-clinical AIDS vaccine research. The general process for the Master Agreement is as follows: (1) Offerors submit proposals demonstrating their technical qualifications and capabilities to perform ALL of the requirements in one or more of the following ten work Categories. Because of the requirements of the review process, SEPARATE AND COMPLETE TECHNICAL AND BUSINESS proposals must be submitted for EACH of the Categories. (2) Proposals are evaluated for technical acceptability by a peer review committee, following the process used for standard contract proposals. Proposals will be evaluated for technical acceptability on the basis of written responses to the requirements in the Statement of Work for each Category, using the Technical Evaluation Criteria for the pertinent Category. Technical acceptability will be determined solely on the basis of the material provided by an Offeror in each written proposal. (3) All Offerors submitting technically acceptable proposals will be awarded Master Agreements and will become members of a pool for the appropriate technical Category. There is no limit to the number of MA Holders who can be in the pool for a Category. (4) No funds accompany the Master Agreements. (5) When NIAID determines that there is a requirement to have services performed or products or reagents made, the NIAID will issue a Master Agreement Order (MAO) RFP to all members of the appropriate pool of MA Holders. (Only MA Holders, because they were technically pre-qualified in the initial peer review process, will receive the MAO RFP.) Those MA holders wishing to respond to a MAO/RFP will submit technical and business proposals. (6) Proposals in response to the MAO/RFP will be evaluated by a review committee. (7) A Master Agreement Order (contract) will then be awarded to the Offeror(s) judged to be able to provide the most cost- effective and technically appropriate service to the Government. Funding will accompany the MAO award. Award of an MAO (contract) is anticipated to be made within 3-6 months of issuance of the MAO RFP. (8) While in most cases only one Offeror from the pertinent MA pool will be awarded any given MAO, it is expected that multiple MAOs will be solicited and awarded. It is possible that MA Holders may receive multiple MAOs. There are ten (10) Master Agreement Categories (A-J) for which MA Holder pools will be established. Offerors wishing to become MA Holders for any Category must submit proposals responding to the Statement of Work for that Category, taking into consideration the Technical Evaluation Criteria for the Category. OFFERORS WISHING TO BE CERTIFIED AS TECHNICALLY QUALIFIED IN MORE THAN ONE CATEGORY MUST SUBMIT SEPARATE, COMPLETE PROPOSALS RESPONDING TO THE REQUIREMENTS OF EACH MA CATEGORY. Offerors may only become MA Holders for Categories for which they submit proposals and for which their proposals are judged to be technically acceptable. GENERAL NOTE TO OFFERORS : In responding to the Master Agreement Statement(s) of Work in this RFP, Offerors should respond to all components of the SOW(s), providing a detailed proposal indicating how each aspect of the Statement of Work for each Category covered in the Offeror's proposal is to be accomplished. (For purposes of simplification of the review of proposals, Offerors should indicate which portions of their proposal for a particular Category are in response to which part of the Statement of Work for that Category, i.e., "pages 1-3 of the proposal correspond to Category G Statement of Work paragraph 4".) Each proposal should reflect a clear understanding of the nature of the work being undertaken, including a brief review of work already published or in progress (both by the Offeror and elsewhere). Methodologies proposed to be used should be described in detail. The proposal should indicate the Offeror's level of experience with the methodology, as well as difficulties which might be anticipated to occur and ways of resolving them. Each proposal should include detailed descriptions of facilities, equipment and other resources AVAILABLE for the conduct of the work proposed to be done to carry out the requirements of the Statement of Work. Documentation should also be provided on the qualifications, experience, accomplishments, education, and availability of the Principal Investigator, the other professional staff proposed for the conduct of the work, and relevant technical and administrative support staff. If outside consultants are to be used, the extent to which they would be involved and WRITTEN ASSURANCE of their commitment and availability are to be provided with the technical proposal. Documentation should also include all previous and current projects of a similar nature, including the contract or grant number, the sponsoring agency, the project officer, and description of the project. It is possible that no single institution may have the expertise and facilities required to perform ALL requirements in any given Category's Statement of Work, and it may be necessary for an Offeror to propose a subcontractor to conduct part of the work. If a subcontractor is proposed, complete information on personnel, experience, facilities, methods, resources, etc. to be provided by the subcontractor should be included in the technical proposal so that the subcontractor's portion of the proposal is as complete as the rest of the proposal. For more detailed information on the preparation of the technical proposal and the business proposal, Offerors should carefully read INSTRUCTIONS TO OFFERORS in this Master Agreement Announcement/RFP. ****************************************************************** STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY A PRODUCTION OF CLINICAL GRADE (GMP- OR GLP-PRODUCED) VACCINES NOTE: Offerors shall submit proposals to be certified technically qualified to produce any, but not necessarily all, of the vaccine types specified in item 1. Offerors must respond to Items 2-6 in addition to Item 1. As used here, the term VACCINE refers to the final formulation of an immunogen. Examples might include, but are not limited to: protein plus adjuvant; antigen formulated in liposomes; or recombinant vector alone. Master Agreement Holders shall have the capability to: 1. Produce one or more HIV vaccines for use in human subjects. Types of vaccines which may be required include (but are not limited to) the following: a. Clinical grade recombinant vaccines (vaccinia, avipox, BCG, salmonella, adenovirus, adeno-associated virus, polio, others) which contain and express genes for HIV proteins, as specified by NIAID. b. Clinical grade purified HIV protein vaccines, as specified by NIAID. c. Clinical grade purified HIV peptide vaccines, as specified by NIAID. d. Clinical grade DNA with sequence(s) of HIV genes or portions of HIV genes, as specified by NIAID. e. Clinical grade anti-HIV polyclonal or monoclonal antibodies, as specified by NIAID. f. Clinical grade attenuated live virus HIV vaccines, as specified by NIAID. g. Clinical grade genome-defective or genome-minus HIV virus particle vaccines, as specified by NIAID. h. Clinical grade inactivated whole virus HIV vaccines, as specified by NIAID. 2. Characterize the above constructs as to purity, immunogenicity, and other criteria to be specified by NIAID. 3. Produce, purify, and package into sterile vials the above candidate vaccines in an appropriate (GMP-certified) facility in a quantity and at a titer or concentration adequate for immunization protocols, as specified by NIAID. 4. Test the vial lots of candidate vaccines for purity, sterility, pyrogenicity, and safety, as specified by NIAID. 5. Provide all documentation for a Vaccine Master File(s) and assist in the formulation of NIAID Investigational New Drug (IND) application(s) for the Food and Drug Administration (FDA). 6. Provide all data, including relevant procedures, to the NIAID or to a designated NIAID contractor. TECHNICAL EVALUATION CRITERIA CATEGORY A: PRODUCTION OF CLINICAL GRADE (GMP- OR GLP-PRODUCED) VACCINES WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 40 points Documented experience, qualifications, and availability of scientific, technical, production, and managerial personnel necessary to carry out the production of the specified vaccine. 2. TECHNICAL APPROACH . . . . . . . . . . . . . . . . . 30 points Appropriateness of technical approach and methodology to be used to obtain quantities of purified, well characterized and quality controlled vaccine which could be used in Phase I/II clinical trials in humans. 3. FACILITIES . . . . . . . . . . . . . . . . . . . . . 20 points Documentation of facilities and equipment appropriate to and necessary for the production of the specified vaccine under good manufacturing practices (GMP) or good laboratory practices (GLP) for human use. 4. ORGANIZATIONAL CAPABILITY . . . . . . . . . . . . . . 10 points Organizational capability and/or experience appropriate for the support of the production of the specified vaccine and preparation of documentation for the U.S. Food and Drug Administration (FDA). TOTAL 100 points ******************************************************************B STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY B EVALUATION OF AIDS VACCINES IN NON-HUMAN PRIMATE MODELS NOTE: Successful offerors will form a pool of Master Agreement Holders capable of carrying out defined aspects of HIV, SIV, or SHIV (SIV-HIV chimeras) vaccine studies using non-human primate models. MA Holders may subsequently be requested to submit proposals in response to Master Agreement Order RFPs asking offerors to: immunize non-human primates so that the immunogenicity of candidate vaccine(s) in non-human primates can be determined; immunize non-human primates with candidate vaccine(s) and challenge with infectious virus; determine the in vivo titer of virus stocks; conduct animal-to-animal transmission studies after immunization; or conduct other related tasks as specified. Master Agreement Holders for this category shall have the capability to perform the following tasks: 1. Provide non-human primates. NOTE: Offerors should indicate what species of monkeys or other non-human primates are currently available and should indicate what species could be acquired in response to an NIAID MAO specifying that a project would be carried out using a particular species or subspecies. Species of monkeys to be used in studies may include, but not be limited to, Macaca mulatta, Macaca nemestrina and Macaca fascicularis. Offerors with the capability of providing baboons for vaccine immunogenicity studies are encouraged to submit a proposal. Offerors with the capability of providing chimpanzees for HIV vaccine studies are encouraged to submit a proposal. For purposes of this proposal, Offerors should consider ten (10) monkeys or four (4) baboons or four (4) chimpanzees to be the minimum number of animals which would be required for a future MAO task, and should consider fifty (50) monkeys or ten (10) baboons or ten (10) chimpanzees to be the maximum number of animals which would be required for any one MAO task. 2. Provide housing, care, and routine health surveillance for non-human primates. The MA holder's facilities shall conform to the standards for animal care outlined in the Guide for the Care and Use of Laboratory Animals as published in the DHHS Publication Number (NIH) 85-23 or succeeding editions, and Public Health Service Policy on Humane Care and Use of Laboratory Animals, Revised September 1986. 3. Provide appropriate biocontainment facilities for housing HIV-infected or SIV-infected non-human primates. 4. Immunize non-human primates with candidate SIV, HIV-1, or HIV-2 vaccine(s) according to a protocol to be jointly developed by the Principal Investigator and staff and the NIAID Project Officer and NIAID staff and approved, before implementation by the Project Officer. Vaccines will be provided by or through NIAID, and may include virus-specific antisera or other PASSIVE vaccines. 5. Monitor immunized animals for acute toxicity, and monitor immunized and infected animals for general health status (i.e., weight, standard blood and chemistry profiles, opportunistic infections, or other assessments specified by NIAID in the MAO.) 6. Infect non-human primates with HIV, SIV, or other relevant viruses to: determine viral infectivity and pathogenicity; determine in vivo titers of virus stocks; challenge immunized animals; assess methods of intervention in animal-to-animal transmission; and/or conduct other related experiments according to a protocol jointly developed by the Principal Investigator and staff and the NIAID Project Officer and staff and approved before implementation by the Project Officer. Viruses may be provided by NIAID or obtained from other sources, as specified by NIAID. NOTE: Because baboons are not able to be infected by most strains of HIV or SIV, MA Holders providing baboons may be exempt from this requirement. 7. Draw blood or obtain other fluids or tissue samples from immunized or infected animals for cell culture, immunological assessment and/or virus culture. Samples shall be processed as directed by NIAID and furnished to NIAID or, upon instruction of the Project Officer, sent directly to the holder of the appropriate Category E MAO or other NIAID contractor or specified laboratory. 8. Obtain tissue for biopsy and virus culture or assessment and conduct autopsies or necropsies. 9. Provide appropriate biocontainment facilities for handling virus and virus-containing tissue from HIV, SIV, or other virus-infected animals. 10. Prepare biopsied and/or autopsied tissues for histological or pathological examination or virological assessment. Perform histological and/or pathological analyses. 11. Provide, maintain, operate, and monitor facilities to store and inventory sera, cells, tissues, or other material from immunized and/or infected animals at -70 to -90 degrees C, in liquid nitrogen, or under other appropriate conditions for the duration of the (future) MAO. Ship materials to a repository or other site, as requested by NIAID. Disposition of materials from the study will be as specified by NIAID. 12. Report data and results to NIAID or to a designated NIAID contractor. 13. Dispose of study animals as instructed by NIAID: Ship animals from the study to other sites, as instructed by NIAID, using shipping procedures and containment appropriate for HIV- or SIV- or other virus-infected animals; or perform necropsies and histopathologic evaluation of study animals, as instructed by NIAID. TECHNICAL EVALUATION CRITERIA CATEGORY B: EVALUATION OF AIDS VACCINES IN N0N-HUMAN PRIMATE MODELS WEIGHT 1. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 50 points Documented availability of non-human primates appropriate to the task. Documented availability of appropriate facilities for housing of non-human primates. Documented availability of biocontainment facilities for housing SIV-infected and/or HIV-infected non-human primates. Documented availability of appropriate biosafety facilities for handling virus and tissue from virus- infected animals. 2. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 35 points Documented experience, qualifications and availability of scientific, technical and veterinary staff necessary to carry out the specified procedures. Capability and experience in the housing and care of non-human primates for virological and/or immunological studies. 3. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 15 points Animal husbandry practices appropriate to the task. Appropriateness of methodology to be used for tasks. TOTAL 100 points ******************************************************************C STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY C THE USE OF IMMUNODEFICIENT MICE TO ASSESS VACCINE RESPONSES NOTE: Successful offerors will form a pool of Master Agreement Holders capable of conducting studies using immunodeficient mice to assess the humoral and cellular immune responses made to candidate HIV vaccines by immunized or HIV-infected humans or animals. Master Agreement Holders for this category shall have the capability to: 1. Provide, house and care for immunodeficient mice. The MA Holder's facilities shall conform to the standards for animal care outlined in the Guide for the Care and Use of Laboratory Animals as published in the Health and Human Services (HHS) Publication, National Institutes of Health (NIH) Number 85-23 or succeeding editions, and Public Health Service Policy on Humane Care and Use of Laboratory Animals, revised September 1986. 2. House the immunodeficient mice in biocontainment facilities appropriate for HIV-infected immunodeficient mice and employ animal handling procedures appropriate for HIV-infected immunodeficient mice. 3. Reconstitute the immunodeficient mice with human tissue containing lymphoid and/or myeloid cells and/or other cells which can be infected with HIV in vivo in the mice, assess reconstitution, and conduct infection of the reconstituted mice with HIV, using an HIV virus stock that has been titered in appropriate immunodeficient mice. 4. Administer various polyclonal or monoclonal antibodies or sera to the reconstituted mice and assess their ability to block in vivo infection of the human cells in the mice with HIV. Antibodies and sera will be provided by or through NIAID. 5. Evaluate the ability of cytotoxic T cells from immunized or HIV-infected human volunteers to block in vivo infection of the human cells with HIV. Cells to be evaluated will be provided by or through NIAID. 6. Conduct other experiments using immunodeficient mice for vaccine efficacy evaluation as may be possible as technological advances are made in immunodeficient mouse systems. 7. Report data and results to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY C: THE USE OF IMMUNODEFICIENT MICE TO ASSESS VACCINE RESPONSES WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 40 points Documented experience, qualifications and availability of scientific, technical and veterinary staff necessary to house and care for immunodeficient mice and conduct the specified tasks with the animals. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 35 points Appropriateness of technical approach and methodology proposed for specified tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 25 points Documented availability of immunodeficient mice. Documented availability of facilities for appropriate housing of immunodeficient mice. Documented availability of containment facilities for housing HIV-infected immunodeficient mice. Documented availability of appropriate biosafety laboratory facilities for handling virus and tissues from virus-infected animals. TOTAL 100 Points ******************************************************************D STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY D THE USE OF OTHER ANIMAL MODELS FOR AIDS VACCINE DEVELOPMENT NOTE: Successful offerors will form a pool of Master Agreement Holders capable of using non-primate models for assessment of vaccines to prevent retrovirus infection. Examples of model systems for which proposals may be submitted include, but are not limited to, proposals to (1) conduct research on a vaccine to prevent infection by a lentivirus other than HIV or SIV; examples might include, but are not limited to, FIV (feline immunodeficiency virus) or EIAV (equine infectious anemia virus); or (2) conduct research on a vaccine to prevent HIV infection, using an animal model other than non-human primates. Master Agreement Holders shall have the capability to: 1. Provide, house, and care for animals (non-human primates) appropriate to the proposed model system. The MA holder's facilities shall conform to the standards for animal care outlined in the Guide for the Care and Use of Laboratory Animals as published in the DHHS Publication Number (NIH) 85-23 or succeeding editions, and Public Health Service Policy on Humane Care and Use of Laboratory Animals, Revised September 1986. 2. Immunize the animals with candidate vaccines appropriate to the model system. 3. Infect the animals with virus appropriate to the proposed model system in order to determine viral infectivity and pathogenicity, to determine in vivo titers of virus stocks, to challenge immunized animals, and/or to conduct other related experiments specified by NIAID. Virus stocks will be provided by the (future) MAO Holder. 4. Assess the immune response of immunized and/or infected animals, using ELISA, western blot, or other appropriate assay(s). 5. Determine whether or not animals are infected by (1) attempting virus isolation from peripheral blood or other tissue, using virus culture and detection methods optimized for the model system; and (2) conducting PCR, antigen capture, and/or other assays on blood and/or other tissues from challenged animals to detect viral nucleic acid or protein. 6. Report data and results to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY D: THE USE OF OTHER ANIMAL MODELS FOR VACCINE DEVELOPMENT WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 40 points Documented experience, qualifications, and availability of scientific, technical, and veterinary staff necessary to house and care for the specified animals and conduct the specified tasks with the animals. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 30 points Appropriateness of technical approach and methodology proposed. Appropriateness of the model proposed. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 30 points Documented availability of appropriate animals and of facilities for housing them, including appropriate biocontainment facilities for housing of lentivirus- infected animals. Documented availability of appropriate biosafety laboratory facilities for handling virus and tissues from virus- infected animals. TOTAL 100 points ******************************************************************E STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY E DETECTION OF ANTIBODIES AND PROTEINS; ISOLATION AND PRODUCTION OF VIRUS NOTE: Successful offerors will form a pool of Master Agreement Holders capable of conducting and developing assays to detect the presence of antibodies to HIV, SIV, SHIV, or other relevant viruses, to detect the presence of HIV, SIV, or other relevant proteins, and to isolate and characterize HIV, SIV, SHIV, or other relevant viruses. The Master Agreement Holders may be requested to isolate other relevant viruses, and to conduct assays to detect other proteins (cellular or viral) and antibodies to them if they become relevant to HIV/SIV vaccine studies. Offerors may submit proposals for determination of technical capability to perform all of the following tasks, or may submit proposals to perform some tasks, with the remainder of the tasks to be performed by subcontractor(s). Proposals containing subcontractor(s) must be complete enough so that the technical expertise/competence of any proposed subcontractor(s) can be as thoroughly evaluated as that of the primary Offeror. Regardless of whether or not the proposal contains subcontractor(s), the technical acceptability of the proposal will be judged on the merits of the ENTIRE proposal. ASSAYS TO DETECT ANTIBODIES AND ANTIGENS The Master Agreement Holders shall have the capability to: 1. Conduct assays (such as ELISA and western blots) to detect antibodies to proteins of HIV, SIV (or other proteins or antigens as specified by NIAID ) in the sera or other fluids of persons or animals immunized with HIV or SIV candidate vaccines or infected with HIV, SIV, or other relevant viruses. 2. Develop assays to detect antibodies to the above proteins or antigens if an assay system is not currently available to detect those antibodies or if existing assays are not of sufficient sensitivity or specificity to provide the information required by NIAID. 3. Conduct assays (such as IFA or RIPA) to detect HIV proteins, SIV proteins, or other proteins or antigens specified by NIAID, in tissues of infected animals or in vitro in infected cells. 4. Conduct assays (such as antigen capture assays or reverse transcriptase assays) to detect HIV proteins, SIV proteins, or other proteins or antigens specified by NIAID, in culture supernatant of viral-infected cells. 5. Conduct assays (such as antigen capture assays) to detect viral antigens or other antigens specified by NIAID in the plasma of people infected with HIV or other relevant viruses or animals infected with SIV, HIV, SHIV, or other relevant viruses. 6. Develop assays to detect viral proteins or other antigens specified by NIAID, if an assay system is not available to detect the protein(s) or other antigens or if existing assays are not of sufficient sensitivity or specificity to provide the information required by NIAID. 7. Report data and results to NIAID or to a designated NIAID Contractor. ISOLATION, CHARACTERIZATION AND PRODUCTION OF VIRUS The Master Agreement Holders shall have the capability to: 1. Isolate SIV, HIV, SHIV, or other relevant viruses from PBMC, lymph nodes, or other tissue or samples of infected animals by co-cultivating the cells or tissue with primary simian and/or human peripheral blood cells, other primary cells, and/or cell lines. 2. Isolate HIV from PBMC or other tissues of HIV-infected people by co-cultivation of the cells, tissue, or other samples with primary human peripheral blood cells, other primary cells, and/or cell lines. 3. Confirm virus transmission to the target cells by demonstration of the presence of virus or viral protein(s) in the culture supernatant and/or the presence of viral protein or nucleic acid in the cultured cells. 4. Characterize HIV, SIV, SHIV, or other relevant virus isolates for infectivity, growth, cell tropism or other in vitro biological properties specified by the NIAID. 5. Transmit the isolated virus(es) to a cell line and provide the infected cells to NIAID for further growth, OR provide a stock(s) of the virus(es) grown only in primary cells for subsequent larger-scale growth in primary cells, as specified by NIAID. (These stocks may be provided to other contractors by NIAID for larger-scale growth.) 6. By dilution of virus or virus-infected cells, obtain and provide single cell clones of cells infected with HIV, SIV, or other relevant viruses with the aim of obtaining biological clones, i.e., cell clones producing only one variant of virus. 7. Produce stocks of virus(es) for challenge studies, titer the virus(es) in vitro in primary cells and/or cell lines, and provide to NIAID. 8. Produce and characterize stocks of virus-infected cells for challenge studies and provide to NIAID. 9. Report data and results to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY E: DETECTION OF ANTIBODIES AND PROTEINS; ISOLATION AND PRODUCTION OF VIRUS WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 50 points Documented experience, qualifications, and availability of personnel necessary to carry out the specified assays and/or procedures. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . .30 points Appropriateness of technical approach and methodology to be used for proposed tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . .20 points Documented facilities and equipment appropriate to and necessary to conduct the specified assays and/or procedures, including biocontainment facilities. TOTAL 100 points ******************************************************************F STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY F PRODUCTION AND PURIFICATION OF VIRAL OR CELLULAR PROTEINS NOTE: Successful offerors will form a pool of Master Agreement Holders capable of purifying HIV viral proteins, SIV viral proteins or other viral or cellular proteins. Offerors proposing to purify proteins from recombinant expression systems should specify which systems(s). Offerors may propose to obtain crude preparations of recombinant proteins from a subcontractor with expertise in a given expression system or may propose to obtain concentrated virus/viral lysates from a subcontractor. Proposals must be complete enough so that the technical expertise of any proposed subcontractor(s) can be evaluated as thoroughly as that of the primary Offeror. Regardless of whether or not the proposal includes subcontractor(s), the technical acceptability of the proposal will be judged on the merits of the ENTIRE proposal. Master Agreement Holders shall have the capability to: 1. Provide or construct recombinant expression vectors (for use in bacterial, insect, or mammalian expression systems) containing inserted genes of HIV-1, HIV-2, SIV, or other genes specified by NIAID; modify each construct, as necessary, to optimize expression of the protein encoded by the gene; and characterize the construct by restriction enzyme analysis and/or DNA sequence analysis. Produce and purify the recombinant viral proteins or other proteins in quantities and of a degree of purity to be specified by NIAID; characterize the purified proteins as to purity, immunogenicity, functional and/or biological properties, or other criteria specified by NIAID. Provide the purified protein(s) to the NIAID. 2. Optionally or alternatively, purify native viral proteins from concentrated HIV-1, HIV-2, SIV, SHIV, or other relevant virions or from virus-infected cells and provide to the NIAID. Concentrated virus and/or cell lines shall be provided by the MAO Holder. NOTE: Because the intent of this MA pool category is to have MA Holders capable of purifying proteins, the source of proteins is secondary. Offerors without facilities to handle viral lysates for purification of native viral proteins are not required to respond to item 2. Offerors wishing to respond only to item 2 will not be excluded from the pool, if judged technically acceptable. 3. Provide data and results concerning purification and characterization of the protein(s) to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY F: PRODUCTION AND PURIFICATION OF VIRAL OR CELLULAR PROTEINS WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 50 points Documented experience, qualifications, and availability of personnel necessary to perform the specified tasks. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 30 points Appropriateness of technical approach and methodology to be used for proposed tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 20 points Documented facilities and equipment appropriate to and necessary for performance of proposed tasks. TOTAL 100 points ******************************************************************G STATEMENT OF WORK for MASTER AGREEMENT CATEGORY G ASSESSMENT OF HUMORAL IMMUNE RESPONSES NOTE: Successful offerors will form a pool of qualified Master Agreement Holders able to provide more sophisticated assessment of humoral immune responses than the assays provided in MA Category E. Offerors may submit proposals to be certified technically qualified to perform all of the following tasks, or may submit proposals to perform some tasks, with the remainder of the tasks to be performed by subcontractor(s). Proposals containing subcontractors must be complete enough so that the technical expertise/ competence of any proposed subcontractor(s) can be as thoroughly evaluated as that of the primary Offeror. Regardless of whether or not the proposal contains subcontractor(s), the technical acceptability of the proposal will be judged on the merits of the entire proposal. Master Agreement Holders shall have the capability to: 1. Conduct assays to assess the functional properties of antibodies from immunized and/or infected animals or persons. Assays that may be required to assess the functional properties of antibodies to HIV, SIV, and/or SHIV (or other relevant antibodies, as specified by NIAID) include, but are not limited to : virus neutralization (including neutralization of field isolates of HIV), fusion inhibition, peptide binding activity, ADCC activity, infectivity enhancing activity, or other assays as specified by NIAID. NOTE: For purposes of this proposal, Offerors shall demonstrate the capability to perform, and experience performing, at least two of the above assays. Develop or improve assays (and conduct those assays) to assess functional properties of antibodies if existing assays are not of sufficient sensitivity or specificity to provide the information required by NIAID. 2. Conduct and/or develop and conduct assays to assess other parameters of humoral immune response to immunization (with HIV, SIV, or other vaccines specified by NIAID) and/or to infection (with HIV, SIV, SHIV, or other viruses specified by NIAID). Assays that may be required include, but are not limited to: detection and characterization of antibodies at mucosal sites, identification of epitope(s) recognized by antibodies, determination of the specificity or the affinity of antibodies, evaluation of immune responses to vaccines in small laboratory animals, and generation and characterization of monoclonal antibodies to viral proteins, peptides, or other antigens specified by NIAID. NOTE: For purposes of this proposal, Offerors shall demonstrate the technical capability to perform, and experience in performing, at least one of the above activities. 3. Report data and results to NIAID and/or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY G: ASSESSMENT OF HUMORAL IMMUNE RESPONSES WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 50 points Documented experience, qualifications, and availability of personnel necessary to perform the specified tasks. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 35 points Appropriateness of technical approach and methodology to be used for proposed tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 15 points Facilities and equipment appropriate to and necessary for the performance of proposed tasks. TOTAL 100 points ******************************************************************H STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY H PRODUCTION OF HUMAN MONOCLONAL ANTIBODIES Master Agreement Holders shall have the capability to: 1. Make and characterize human monoclonal antibodies directed against HIV antigens (or other antigens, as specified by NIAID) from HIV-infected persons and/or persons immunized with HIV vaccines; provide the immunoglobulin molecular clones and/or antibody-producing cell clones to NIAID. 2. Produce, characterize, and provide human monoclonal antibodies to NIAID. 3. Report data and results to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY H: PRODUCTION OF HUMAN MONOCLONAL ANTIBODIES WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 50 points Documented experience, qualifications, and availability of personnel necessary to perform the specified tasks. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . .35 points Appropriateness of technical approach and methodology to be used for proposed tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . .15 points Facilities and equipment appropriate to and necessary for performance of proposed tasks. TOTAL 100 points ******************************************************************I STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY I ASSESSMENT OF CELLULAR IMMUNE RESPONSES NOTE: Successful offerors will form a pool of Master Agreement Holders capable of providing assessment of the cellular immune response to HIV, SIV, SHIV, and/or other relevant antigens in immunized and/or infected humans and/or animals. Offerors may submit proposals to be certified technically qualified to perform all of the following tasks, or may submit proposals to perform some tasks, with the remainder of the tasks to be performed by subcontractor(s). Proposals containing subcontractor(s) must be complete enough so that the technical expertise/competence of any proposed subcontractor(s) can be as thoroughly evaluated as that of the primary Offeror. Regardless of whether or not the proposal contains subcontractor(s), the technical acceptability of the proposal will be judged on the merits of the ENTIRE proposal. Master Agreement Holders shall have the capability to: 1. Conduct and/or develop and conduct assays to detect and characterize cytotoxic T cells directed against HIV and/or SIV proteins (or other proteins as directed by NIAID) in immunized and/or infected people or animals. 2. Clone cytotoxic T lymphocytes, determine the epitope recognized by the clone(s), and determine the HLA restriction of the clone(s). Provide the clone(s) to NIAID. 3. Conduct and/or develop and conduct assays to assess other parameters of cellular immune response to immunization (with HIV, SIV, or other vaccines specified by NIAID) and/or to infection (with HIV, SIV, or other viruses specified by NIAID). NOTE: Assays that may be required include, but are not limited to: assessment of anti-viral CD8 suppressor cell activity; assessment of antigen-specific lymphoproliferation; measurement of production and/or release of IL-2 or other cytokines or factors; assessment of macrophage and/or T cell function; phenotyping of CD4 and CD8 lymphocytes; or other assays as specified by NIAID. For purposes of this proposal, Offerors shall demonstrate the technical capability to perform, and experience in performing, at least two assays to assess other parameters of cellular immune response to HIV or SIV. 4. Report data and results to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY I: ASSESSMENT OF CELLULAR IMMUNE RESPONSES WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 50 points Documented experience, qualifications, and availability of personnel necessary to perform the specified tasks. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 35 points Appropriateness of technical approach and methodology to be used for proposed tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 15 points Facilities and equipment appropriate to and necessary for performance of proposed tasks. TOTAL 100 points ******************************************************************J STATEMENT OF WORK FOR MASTER AGREEMENT CATEGORY J MOLECULAR BIOLOGY SUPPORT FOR DEVELOPMENT AND ASSESSMENT OF VACCINES NOTE: Successful offerors will form a pool of qualified Master Agreement Holders able to provide molecular biology services or products. Offerors may submit proposals for determination of technical capability to perform all of the following tasks (1-5), or may submit proposals to perform some of tasks, with the remainder of the tasks to be performed by subcontractor(s). Proposals containing subcontractors must be complete enough so that the technical expertise/competence of any proposed subcontractor(s) can be as thoroughly evaluated as that of the primary Offeror. Regardless of whether or not the proposal contains subcontractor(s), the technical acceptability of the proposal will be judged on the merits of the ENTIRE proposal. Master Agreement Holders shall have the capability to: 1. Conduct and/or develop and conduct assays (such as PCR or restriction endonuclease analysis) to detect and characterize viral nucleic acid sequences (or other specific nucleic acid sequences specified by NIAID), in tissues of HIV-infected people and/or virus-infected animals, in virus-infected cells in culture, or other samples specified by NIAID. 2. Provide molecular cloning capability in support of AIDS vaccine research, as specified by NIAID. NOTE: Types of molecular cloning services which may be required include, but are not limited to, the following activities, in which Offerors would be requested to: a. Molecularly clone HIV and/or SIV genomes or genes (or other genes as specified by NIAID), characterize, and provide the clones to NIAID. b. Construct and characterize mutated, chimeric, or otherwise modified viruses, viral genomes, viral genes, and/or other genes specified by NIAID, and provide them to NIAID. c. Construct and characterize recombinant vaccine vectors containing and expressing viral genes (or other genes specified by NIAID) and provide the recombinants to NIAID. d. Clone genes for immunoglobulins which have specificity for HIV, SIV, and/or other relevant antigens; characterize and provide the clones to NIAID. e. HUMANIZE mouse monoclonal antibodies directed against HIV and/or SIV antigens by constructing mouse-human chimeric antibodies; provide the antibodies to NIAID. For purposes of this proposal, Offerors shall demonstrate the technical capability to perform, and experience in performing, at least one of the above activities. 3. Sequence HIV, SIV, and/or other relevant genomes or portions of genomes, as specified by NIAID. 4. Produce and purify DNA and/or RNA from viral-infected cells, from plasmids, or from other sources, and characterize it, as specified by NIAID. Provide the purified DNA and/or RNA to NIAID. 5. Report data and results to NIAID or to a designated NIAID Contractor. TECHNICAL EVALUATION CRITERIA CATEGORY J: MOLECULAR BIOLOGY SUPPORT FOR DEVELOPMENT AND ASSESSMENT OF VACCINES WEIGHT 1. PERSONNEL . . . . . . . . . . . . . . . . . . . . . . 45 points Documented experience, qualifications, and availability of personnel necessary to perform the specified tasks. 2. TECHNICAL APPROACH/METHODOLOGY . . . . . . . . . . . 40 points Appropriateness of technical approach and methodology to be used for the proposed tasks. 3. RESOURCES AND FACILITIES . . . . . . . . . . . . . . 15 points Facilities and equipment appropriate to and necessary for performance of proposed tasks. TOTAL 100 points ******************************************************************* ******************************************************************* RFP-NIH-NIAID-DAIDS-96-17 ATTACHMENT 2, OCTOBER 26, 1995 SECTION M - EVALUATION FACTORS FOR AWARD 1. GENERAL The technical proposal will receive sole consideration in selecting MA Holders for this acquisition. The evaluation will be based on the demonstrated capabilities of prospective MA Holders in relation to the needs of the project as set forth in the MAA. The merits of each proposal will be evaluated carefully, based on responsiveness to the MAA and the thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Failure to provide the information required to evaluate the proposal may result in the rejection of that proposal without further consideration. The evaluation criteria are used by the technical evaluation committee to evaluate the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. 3. TECHNICAL EVALUATION CRITERIA - MASTER AGREEMENT Attachment 1 (Statements of Work for the ten work categories) details the evaluation criteria per Master Agreement Category. 4. TECHNICAL EVALUATION CRITERIA - SAMPLE MASTER AGREEMENT ORDER (PROVIDED FOR INFORMATION ONLY) ******************************************************************* ******************************************************************* MAA\RFP-NIH-NIAID-DAIDS-96-17 ATTACHMENT 3 10/25/96 INSTRUCTIONS, CONDITIONS, NOTICES TO OFFERORS, AND FORMS GENERAL INFORMATION 1. SOLICITATION DEFINITIONS A MASTER AGREEMENT ANNOUNCEMENT (MAA) is a notice inviting potentially qualified sources to submit their approaches, qualifications and experience to perform research and development studies, support or evaluation studies in a particular scientific/technical area. A MASTER AGREEMENT (MA) is the instrument issued to sources who responded to a MAA, and who were judged to be qualified to compete for future orders issued under the general project area or areas defined in the MA. A MASTER AGREEMENT ORDER/REQUEST FOR PROPOSALS (MAO/RFP) is the solicitation document issued to MA Holders inviting them to compete for the specific study, Research & Development, resource support or evaluation project or projects described in the MAO/RFP. A MASTER AGREEMENT ORDER (MAO) is a bilateral award document issued to the MA Holder who successfully competed for the requirement(s) described in a MAO/RFP. MA TYPE AND GENERAL PROVISIONS: It is contemplated that MAOs awarded under this MA may be either cost reimbursement or fixed price type (See General Information). Any resultant MA shall include the clauses applicable to the selected offeror's organization and type(s) of MAOs expected to be awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed MA. 2. SIC CODE AND SMALL BUSINESS SIZE STANDARD (JANUARY 1991), FAR 52.219-22 (a) The standard industrial classification (SIC) code for this acquisition is 8731. (b) (1) The small business size standard is 500. (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. (c) 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. 3. AWARD A Master Agreement will be awarded to each Technically Acceptable offeror responding to this MAA. It is anticipated that award will be made in the Spring of 1996 for the period ending June 1999. The Master Agreements awarded from this MAA will not be funded. After award, the Master Agreement holders will be invited to compete on appropriate Master Agreement Orders as they are issued. Individual Master Agreement Orders will be issued on either a cost reimbursement or fixed price basis, whichever is deemed appropriate by the Contracting Officer. 4. ESTIMATE OF EFFORT The Government's estimate of effort will be provided with each MAO/RFP. For responding to this MAA/RFP your technical proposal must include estimates of effort that pertinent individuals will be available for this program (your attention is directed to the technical proposal instructions in this section). 5. COMPARATIVE IMPORTANCE OF PROPOSALS You are advised that for MAs, the technical score will be the sole determination if an offeror is selected for award. All technically acceptable proposals will receive an MA award. 6. SERVICE OF PROTEST, (NOVEMBER 1988) - FAR 52.233-2. (a) 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) or the General Services Administration Board of Contract Appeals (GSBCA) shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgement of receipt from: Hand Carried Address: Mr. Lewis Pollack National Institute of Allergy and Infectious Diseases, NIH Contract Management Branch, DEA SOLAR Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 Mailing Address: Mr. Lewis Pollack National Institute of Allergy and Infectious Diseases, NIH Contract Management Branch, DEA SOLAR Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20892-7610 (b) The copy of any protest shall be received in the office designated above on the same day a protest is filed with the GSBCA or within one day of filing a protest with the GAO. ******************************************************************* GENERAL INSTRUCTIONS TO OFFERORS 7. PACKAGING AND DELIVERY OF THE PROPOSAL 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-96-17" "TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY" Number of Copies: ________________ PLEASE NOTE - THE TECHNICAL PROPOSAL SHALL BE SENT IN SPLIT SHIPMENTS TO TWO LOCATIONS. PLEASE READ THE FOLLOWING INFORMATION CAREFULLY: A. TECHNICAL PROPOSAL ONLY ORIGINAL* AND 2 COPIES TO: If hand delivered or delivery service ------------------------------------- Contract Specialist Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 If using U.S. Postal Service ---------------------------- Contract Specialist Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20982-7610 20 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, Maryland 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, Maryland 20982-7610 B. BUSINESS PROPOSAL ORIGINAL* AND 2 COPIES TO: If hand delivered or delivery service ------------------------------------- Contract Specialist Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard Rockville, Maryland 20852 If using U.S. Postal Service ---------------------------- Contract Specialist Contract Management Branch DEA, NIAID, NIH Solar Building, Room 3C07 6003 Executive Boulevard MSC 7610 Bethesda, Maryland 20982-7610 * THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES 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" and handled in accordance with PHSAR 352.215-10 LATE PROPOSALS, MODIFICATIONS OF PROPOSALS AND WITHDRAWALS OF PROPOSALS (NOV 1986). 8. EVALUATION OF PROPOSALS The Government will evaluate MA technical proposals in accordance with the criteria set forth in this MAA (the criteria for the SAMPLE MAO are for information only). 9. CARE OF LIVE VERTEBRATE ANIMALS The following notice is applicable when MAO performance is expected to involve care of Live Vertebrate Animals: PHSAR 352.802-2(a) NOTICE TO OFFERORS OF REQUIREMENT FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS (SEPTEMBER 1985) The PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions establishes a number of requirements for research activities involving animals. Before a PHS award may be made to an applicant organization, the organization shall file, with the Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), PHS, a written Animal Welfare Assurance which commits the organization to comply with provisions of the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources. In accordance with the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, applicant organizations must establish a committee, qualified through the experience and expertise of its members, to oversee the institution's animal program facilities and procedures. No PHS award involving the use of animals shall be made unless the Animal Welfare Assurance has been approved by OPRR. Prior to award, the contracting officer will notify Contractor(s) selected for projects that involve live vertebrate animals that an Animal Welfare Assurance is required. The contracting officer will request that OPRR negotiate an acceptable Animal Welfare Assurance with those Contractor(s). For further information, OPRR may be contacted at NIH, Bethesda, Maryland 20892, 301/496-7041. 10. ADDITIONAL PROPOSAL INSTRUCTIONS A listing of additional instructions and notices required for proposal preparation is provided below. The full text versions of these provisions are contained in the NIH Gopher directory entitled "Instructions for Proposal Submission". - NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE - 52.227-6 ROYALTY INFORMATION (APR 1984) - 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (JUN 1988) - COMMITMENT OF PUBLIC FUNDS (NIH 2455) (JUL 1986) - COMMUNICATIONS PRIOR TO CONTRACT AWARD (NIH 2345) (FEB 1990) - RELEASE OF INFORMATION (NIH 3170) (JUL 1994) - PREPARATION COSTS (NIH 3173) (JUL 1994) - PHSAR 352.215-10 LATE PROPOSALS, MODIFICATIONS OF PROPOSALS AND WITHDRAWALS OF PROPOSALS (NOV 1986) - CONTRACT CLAUSES (NIH 3120) (JUN 1986) - FORMAT AND CONTENT OF PROPOSALS (NIH 3121) (JUL 1994) - SEPARATION OF TECHNICAL AND BUSINESS PROPOSALS (NIH 3122) (JUL 1994) - ALTERNATE PROPOSALS (NIH 3123) (JUL 1994) - CONFIDENTIALITY OF PROPOSALS (NIH 3124) (JUL 1994) - USE OF THE METRIC SYSTEM OF MEASUREMENT (NIH 3126) (JUL 1994) - SELECTION OF OFFERORS (NIH 3130) (JUL 1986) - SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS SUBCONTRACTING PLAN (NIH 3135) (JUL 1986) - REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS (NIH 3165) (JUL 1994) - SALARY RATE LIMITATION INFORMATION FOR OFFERORS (NIH 3101) (OCT 1994) - TECHNICAL PROPOSAL INSTRUCTIONS (NIH 3500) (JUL 1994) - TECHNICAL DISCUSSIONS (NIH 3505) (JUL 1994) - TECHNICAL EVALUATION (NIH 3510) (JUL 1994) - ADDITIONAL TECHNICAL PROPOSAL INFORMATION (NIH 3165) (JUL 1994) - OTHER CONSIDERATIONS (NIH 3520) (JUL 1994) - COST AND PRICING DATA (NIH 3600) (JUL 1994) - QUALIFICATIONS OF THE OFFEROR (NIH 3615) (JUL 1994) - PROPERTY/EQUIPMENT/FACILITIES (NIH 3620) (JUL 1994) - ROYALTIES (NIH 3625) (JUL 1994) - FINANCIAL CAPACITY (NIH 3630) (JUL 1994) - SUBCONTRACTORS (NIH 3635) (JUL 1994) - INCREMENTAL FUNDING (NIH 3640) (JUL 1994) - REPRESENTATIONS AND CERTIFICATIONS (NIH 3645) (JUL 1994) - NOTICE TO OFFERORS - FORMS/FORMATS/ATTACHMENTS (NIH 3145) (JUL 1986) ******************************************************************* ******************************************************************* RFP-NIH-NIAID-DAIDS-96-17 ATTACHMENT D 10/26/95 ADVANCE UNDERSTANDING PROPRIETARY DATA CONFIDENTIALITY Due to the sensitive nature of the data generated through this Program, the MA Holder will be required to keep all data confidential. No data are to be disclosed or disposed of without the consent of the Project Officer. Furthermore, certain data and other information provided to the MA Holder shall require confidential treatment. The data to be treated confidentially pertain to proprietary information provided by the sponsors of therapies and by other researchers. Unless otherwise specified by the Project Officer, all study-related information provided to the MA Holder must be treated as confidential by the MA Holder. An advance understanding will be included in future MAO/RFPs and resulting MAO awards (if deemed appropriate by the Project Officer and Contracting Officer) addressing this issue as follows: "The MA Holder agrees that manuscripts/abstracts based on data/information generated under this MAO will not be submitted for publication until written Project Officer clearance has been received. A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information. MAO support shall be acknowledged in all such publications. "The Project Officer will, within a period of time not to exceed 30 calendar days from receipt, refer the document to the Third Party Supplier of the materials, review the manuscript with respect to accuracy and subject confidentiality, and will either grant clearance for publication/disclosure or recommend changes. The NIAID will use its best efforts to assist and expedite the review process by the Third Party Suppliers wherever possible." ******************************************************************* *******************************************************************