RFP No. NIH-NIAID-DAIDS-97-02
Title: PRECLINICAL EVALUATION OF THERAPIES FOR MICROSPORIDIAL
INFECTION
Issued by: Phillip Hastings
Contract Specialist
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
DATE ISSUED: APRIL 15, 1996
PROPOSAL DATE DUE: AUGUST 15, 1996, 4:30 P.M. (EST)
Ladies and Gentlemen:
You are invited to submit a proposal in accordance with the
requirements of this RFP (NIH-NIAID-DAIDS-97-02) for a PRECLINICAL
EVALUATION OF THERAPIES FOR MICROSPORIDIAL INFECTION. The
Government contemplates the award of one (1), five (5) year,
cost-reimbursement, level-of-effort type Contract as a result of
this RFP.
The documents included with this electronic RFP package are as
follows:
I. Streamlined RFP
a. Introduction and Work Statement, dated April 15, 1996
(Attachment 1)
b. Deliverables and Reporting Requirements, dated April 15,
1996 (Attachment 2)
c. Evaluation Factors for Award, dated April 15, 1996
(Attachment 3)
II. Specific RFP Instructions and Provisions, dated April 15, 1996
(Attachment 4)
III. Applicable RFP References, dated April 15, 1996 (Attachment 5)
IV. Agreement for Submitting Products to the Division of AIDS
(Attachment 6)
In addition to this directory which provides access to this
streamlined RFP, there are five (5) other subdirectories in the
Gopher System (under C. RFP References) which must be retrieved, in
whole or in part, in order to submit a proposal. (These are
detailed in Attachment 5.) If you are unable to download any of
these documents, please contact Phillip Hastings, Contract
Specialist, by phone/fax/internet. (See contact numbers/addresses
below.)
The attachments listed above represent all the necessary
information required for the submission of a proposal for this
acquisition. Following proposal submission and review, additional
information will be requested by the Contracting Officer from all
Offerors which comprise the competitive range.
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, but supporting documentation need not be
submitted with the proposal. (COST AND PRICING DOCUMENTATION WILL
BE REQUESTED AFTER THE COMPETITIVE RANGE IS ESTABLISHED.) See
Standard RFP Instructions and Provisions, in the subdirectory C.
RFP References, for more detail on the BUSINESS PROPOSAL
requirements.
DUE TO THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES'
CURRENT BUDGET RESTRICTIONS, IT IS RECOMMENDED THAT ANY PROPOSED
ANNUAL INCREASE IN COSTS FOR INFLATION BE LIMITED TO NO MORE THAN
4% OF TOTAL COSTS PER YEAR WHICH IS ALSO THE MAXIMUM CURRENTLY
ALLOWED BY THE NIH FOR RESEARCH PROJECTS. FINAL INFLATION
INCREASES WILL BE SUBJECT TO THE NEGOTIATION PROCESS TAKING INTO
CONSIDERATION THE MOST CURRENT CONSUMER PRICE INDEX (CPI).
With the Business Proposal, please submit Form NIH-2043, "Proposal
Summary and Data Record," contained in the NIH Gopher under the
FORMS, FORMATS, AND ATTACHMENTS subdirectory found in C. RFP
REFERENCES. Note that in addition to telephone and fax numbers,
the INTERNET addresses of both the Principal Investigator and the
responsible business representative are to be included on the form.
The format and content of your TECHNICAL PROPOSAL is detailed in
the technical proposal Table of Contents, Attachment 4. BE
ADVISED THAT THE NARRATIVE OF THE WORK STATEMENT, RESOURCES AND
DIRECT COSTS, PERSONNEL, AND OTHER CONSIDERATIONS ARE NOT TO EXCEED
50 PAGES. You are reminded that the "Technical Proposal Cover
Sheet" must be completed in full detail and used as the cover sheet
for each copy of your technical proposal. (A copy of this form is
contained in the NIH Gopher under the FORMS, FORMATS, AND
ATTACHMENTS subdirectory found in C. RFP REFERENCES.) 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, 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.
Your attention is further directed to the "Proposal Intent" form
contained in Attachment 4, item 11. Please complete this form and
return it to this office on or before July 15, 1996. This will
allow us to expedite preparations for the peer review of proposals.
Funds are not presently available for this requirement. The
Government's obligation under a resulting Contract is contingent
upon availability of appropriated funds from which payment for
Contract purposes can be made.
If you intend to submit a proposal in response to this RFP, IT IS
ESSENTIAL THAT YOU IMMEDIATELY NOTIFY MR. PHILLIP HASTINGS,
CONTRACT SPECIALIST, OF THE NIAID CONTRACTING OFFICE AT THE
FOLLOWING INTERNET ADDRESS:
ph23k@nih.gov
IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU
WILL NOT RECEIVE ANY NOTIFICATION OF AMENDMENTS ISSUED TO THE RFP.
HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH GOPHER AND/OR NIH
HOME PAGE.
The original and twenty (20) copies of your technical proposal and
the original and five (5) copies of your business proposal must be
received by the Contract Specialist no later than August 15, 1996,
at 4:30 p.m. local time at the address listed in Attachment 4, item
5.
Questions concerning any areas of uncertainty which in your opinion
require clarification or correction, must be furnished in writing
to Phillip Hastings. Your questions should be received no later
than May 15, 1996, at the address indicated in Attachment 4, item 5
(Fax or E-mail is also acceptable.) and marked "Offeror's
Questions, RFP-NIH-NIAID-DAIDS-97-02."
If you have any additional questions regarding this RFP, please
contact Phillip Hastings at the internet electronic mail address
ph23k@nih.gov, by phone at 301/496-0194, or by fax at 301/402-0972. Collect calls will NOT be accepted.
Sincerely,
/s/
Brenda J. Velez
Chief, AIDS Clinical Research Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases
Attachments: 1 - 6
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RFP-NIH-NIAID-DAIDS-97-02
I. STREAMLINED RFP
-------------------
ATTACHMENT 1
4/15/96
INTRODUCTION
------------
The opportunistic infections (OIs) resulting from advanced HIV
disease are principal causes of morbidity and mortality. Several
species of parasites belonging to the phylum MICROSPORA cause
disease in immunocompromised hosts, including people with AIDS.
Microsporidia have only recently been recognized as human pathogens
and opportunistic infections, thus the field is a very new area of
study. AIDS patients commonly develop chronic diarrhea, and other
clinical manifestations that may include keratitis, nephritis,
pneumonia, hepatitis, peritonitis, and sinusitis. Gastrointestinal
infections comprise the vast majority of microsporidiosis cases.
Prevalence in the US and Europe ranges from 7-50% in various HIV-
infected populations. There are no preventive therapies and no
established or proven treatments for active disease. Therapies for
ocular infections and one GI infection are under investigation,
however these are species-specific and are not always curative or
microbicidal. There is no therapy for ENTEROCYTOZOON BIENEUSI, the
most common of the microsporidial infections causing a debilitating
diarrhea.
The Division of AIDS (DAIDS), NIAID has taken the lead in
supporting OI drug development efforts by providing Contract
resources for evaluating promising new therapies in animals, a
critical component in the drug approval process. This RFP
represents a segment of the Opportunistic Infections Research
Branchþs drug discovery and development program, through which drug
testing resources are made available to scientific investigators
and to companies without comparable resources. The availability of
these test systems will allow DAIDS to provide needed support for
investigator-initiated drug discovery, to stimulate private sector
sponsorship of new drugs, to perform comparison studies of drugs
from different sponsors, and to provide information for selection
of anti-microsporidial drug candidates for design of clinical
studies. At the present time, NIAID does not have any resource for
testing therapies against microsporidia. The new Contract
resulting from this RFP will develop and validate IN VITRO and IN
VIVO models of microsporidial infection that are suitable for
testing new therapies. The IN VITRO and IN VIVO models established
and validated through this Contract will serve to test candidate
antibiotics and provide a standard system to assist pathogenesis,
parasite biology, drug resistance and diagnostics research.
The state-of-the-art of research on this group of pathogens is such
that a few species can be cultured and limited animal models are
under development for ENCEPHALITOZOON-type species. A major
obstacle to progress in this area is that there is no culture
system or animal model of the most common microsporidial pathogen,
ENTEROCYTOZOON BIENEUSI, to support pathogenesis and drug discovery
research. Therefore the emphasis of this Contract is to fill the
gaps in knowledge and methodology regarding research on E.
BIENEUSI. Due to the current limitations of working with this
organism, the first year of the Contract will be used to further
develop proposed IN VITRO and IN VIVO models of E. BIENEUSI
infection. Evaluation of experimental therapies is anticipated for
years 2-5, along with continued efforts to improve the models.
Selected studies using models of another MICROSPORA, such as
SEPTATA (ENCEPHALITOZOON) INTESTINALIS, will be included under
certain conditions described below.
It is anticipated that one Contract will be awarded, dependent upon
availability of funds. We anticipate that one year will be
adequate to focus on E. BIENEUSI model development work. However,
progress will be monitored closely and the Project Officer will
determine the extent to which compound testing will be done with
either the E. BIENEUSI models or the alternative models that have
been validated in the remaining Contract years.
The Government reserves the right to determine whether adequate
progress has been made after the initial year of model development
work and whether the Contract should be continued, reduced,
modified, or terminated for the convenience of the Government.
------------------------------------------------------------
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[GENERAL NOTE TO OFFEROR: IN RESPONDING TO THIS RFP, OFFERORS
SHOULD DESCRIBE IN DETAIL THE TECHNICAL APPROACH AND METHODS
PROPOSED, AND THE RESPONSIBILITIES AND LEVEL OF EFFORT OF ALL
PROPOSED PERSONNEL WHO WILL BE ASSIGNED TO THE CONTRACT.
DOCUMENTATION SHOULD ALSO BE PROVIDED ON THE QUALIFICATIONS,
EXPERIENCE, EDUCATION, COMPETENCE, AVAILABILITY IN RELATION TO
OTHER COMMITMENTS, AND DECISION-MAKING AUTHORITY OF THE PRINCIPAL
INVESTIGATOR, KEY PERSONNEL, AND TECHNICAL AND SUPPORT STAFF.
OFFERORS SHOULD DESCRIBE IN DETAIL AN ADMINISTRATIVE FRAMEWORK
SHOWING CLEAR LINES OF AUTHORITY. A DETAILED WORK PLAN SHOWING
PROPOSED TIME SCHEDULES SATISFACTORY FOR ACHIEVING CONTRACT
OBJECTIVES AND MILESTONES, AND FOR MAINTAINING QUALITY CONTROL OVER
THE IMPLEMENTATION AND OPERATION OF THE CONTRACT SHOULD BE
INCLUDED. OFFERORS SHOULD PROVIDE NECESSARY FACILITIES, INCLUDING
ALL MAJOR EQUIPMENT, AND CAPABILITIES TO PERFORM ALL THE FUNCTIONS
OF THE WORK STATEMENT. IN THE TECHNICAL APPROACH FOR ACCOMPLISHING
THE WORK STATEMENT, DISCUSSION OF POTENTIAL PROBLEMS OF PROPOSED
MODELS, AND SUGGESTED SOLUTIONS SHOULD BE INCLUDED IN THE TECHNICAL
PROPOSAL.
DOCUMENTATION SHOULD BE PROVIDED ON THE QUALIFICATIONS, EXPERIENCE,
EDUCATION, COMPETENCE, AVAILABILITY, AND DECISION-MAKING AUTHORITY
OF THE PRINCIPAL INVESTIGATOR, TECHNICAL AND ADMINISTRATIVE SUPPORT
STAFFS; THE EXTENT TO WHICH OUTSIDE CONSULTANTS SHOULD BE USED AS
WELL AS ASSURANCE OF THEIR AVAILABILITY; AND THE PERCENTAGE OF TIME
EACH STAFF MEMBER (INCLUDING PROPOSED SUBCONTRACTORS AND
CONSULTANTS) WHO SHOULD CONTRIBUTE TO THE PROJECT. RESUMES,
ENDORSEMENTS, AND EXPLANATIONS OF PREVIOUS EFFORTS SHOULD CLEARLY
DEMONSTRATE RELEVANT TRAINING, EXPERIENCE, AND SPECIFIC
ACCOMPLISHMENTS. DOCUMENTATION SHOULD INCLUDE ALL PREVIOUS AND
CURRENT PROJECTS OF A SIMILAR NATURE, INCLUDING THE CONTRACT NUMBER
OR GRANT NUMBER, THE SPONSORING AGENCY, AND THE PROJECT TITLE.
OFFERORS SHOULD ADDRESS PLANS TO INSURE THAT NO IDENTIFIABLE DATA
ON THE COMPOUNDS OR PRODUCTS AND THE RESULTS OF TESTING WILL BE
KEPT IN FILES OPEN TO THE PUBLIC, AND THAT FACILITIES FOR COMPUTER
OPERATION, DATA ENTRY, AND FILE STORAGE ARE SECURE FROM
UNAUTHORIZED ACCESS. ONLY THOSE CONTRACT EMPLOYEES OR GOVERNMENT
EMPLOYEES DIRECTLY ENGAGED IN THIS PROJECT WILL HAVE ACCESS TO THE
FILES OF INFORMATION REGARDING SOURCE AND NATURE OF CONFIDENTIAL OR
PROPRIETARY MATERIALS AND RESULTS OF TESTING.
THE HANDLING AND TRANSPORTATION OF ALL REAGENTS AND GOVERNMENT-
OWNED PROPERTY UNDER ANY RESULTANT CONTRACT SHOULD BE IN ACCORDANCE
WITH ALL APPLICABLE LOCAL, STATE AND FEDERAL REGULATIONS INCLUDING
HEALTH AND SAFETY STANDARDS (SEE ATTACHMENT 4 FOR THE SAFETY AND
HEALTH CLAUSE AND ITEM #10 OF THE WORK STATEMENT).
IF A SUBCONTRACTOR IS PROPOSED, SIMILAR TECHNICAL INFORMATION
SHOULD BE PROVIDED AS PART OF THE PROPOSAL AS THAT REQUIRED OF THE
PRIME CONTRACTOR, I.E., TECHNICAL APPROACH, METHODS, EXPERIENCE,
PERSONNEL QUALIFICATIONS, FACILITIES, RESOURCES, ETC., AND COST
DETAILS SHOULD ALSO BE PROVIDED BY THE SUBCONTRACTOR. THE PRIME
CONTRACTOR SHALL BE RESPONSIBLE FOR ALL WORK PERFORMED UNDER THIS
CONTRACT.]
WORK STATEMENT
______________
Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary technical and administrative
services, qualified personnel, material, equipment, strains of
microorganisms, and facilities, not otherwise provided by the
Government as needed to perform the Work Statement below.
Specifically, to facilitate discovery and development of therapies
against enteric microsporidial infection, the Contractor shall:
1. Improve, standardize and validate a proposed model of E.
BIENEUSI infection in mice that is suitable for evaluation of
potential new therapies for treatment of microsporidial
infections.
The mouse model system shall include the following minimum
requirements:
a. A reproducible course of infection with unambiguous,
quantitative indicators of morbidity that
approximate and have relevance to those seen in
human enteric infections;
b. A protocol for testing therapies against
established E. BIENEUSI infection including an
experimental agent with potential suitability
as a positive control;
c. Quantitative assessments that detect statistically
valid differences between treatment groups of
animals;
d. Histochemical, molecular, microbiological and/or
other methods to document species identity, purity,
severity, pathology and location of infection; and
e. Appropriate measures of general toxicity of the
experimental therapy during efficacy studies.
[NOTE 1 TO OFFEROR: THE OFFEROR SHOULD PROPOSE A CANDIDATE MOUSE
MODEL OF E. BIENEUSI INFECTION AND A THERAPEUTIC PROTOCOL FOR
DEVELOPMENT. THE OFFEROR SHOULD SUBMIT A DETAILED RESEARCH PLAN
AND TIMELINE FOR ACHIEVING A MOUSE MODEL OF E. BIENEUSI INFECTION
AND A TESTING PROTOCOL WITH THE ABOVE CHARACTERISTICS (1. A-E).
THE RESEARCH PLAN SHOULD DESCRIBE EXPERIMENTS THE OFFEROR INTENDS
TO CONDUCT IN ORDER TO DEVELOP, STANDARDIZE AND VALIDATE THE IN
VIVO MODEL, INCLUDING THE IDENTIFICATION OF AN AGENT THAT CAN BE
USED AS A POSITIVE CONTROL IN EFFICACY EVALUATIONS, AND SHOW HOW
WORK WILL BE PHASED TO COMPLETE INITIAL STANDARDIZATION AND
VALIDATION OF THIS MODEL AND PROTOCOL. FOR PURPOSES OF PLANNING
WORK AND PREPARING THE BUSINESS PROPOSAL, THE OFFEROR SHOULD ASSUME
THAT THIS DEVELOPMENT PHASE WILL BE COMPLETE BY THE END OF YEAR 1.
OFFERORS SHOULD CLEARLY IDENTIFY THE YEAR 1 RESEARCH PLAN IN THE
TECHNICAL PROPOSAL AND DOCUMENT A RELIABLE SOURCE OF PARASITES FOR
THIS WORK.
THE OFFEROR SHOULD PROVIDE DOCUMENTATION OF THE METHODS THAT WILL
BE EMPLOYED TO CONFIRM THE MICROBIOLOGICAL PURITY OF THE
EXPERIMENTAL INFECTION AND THE ABSENCE OF OTHER PATHOGENIC
MICROORGANISMS. THE PROPOSED MODEL SHOULD APPROXIMATE THE CLINICAL
MANIFESTATIONS OF THE INFECTION AS IT OCCURS IN AIDS, OR SHOULD
OTHERWISE HAVE DOCUMENTED UTILITY FOR TESTING DRUG EFFICACY. IN
THE TECHNICAL APPROACH FOR ACCOMPLISHING THE WORK STATEMENT,
DISCUSSION OF POTENTIAL PROBLEMS OF THE PROPOSED MODEL, AND
SUGGESTED SOLUTIONS SHOULD ALSO BE INCLUDED IN THE TECHNICAL
PROPOSAL.
FOR THE PURPOSES OF PREPARING THE BUSINESS PROPOSAL, THE OFFEROR
SHOULD BE SPECIFIC IN DESCRIBING THE COSTS FOR DEVELOPMENTAL WORK,
I.E., COSTS FOR THE NUMBER OF EXPERIMENTS, ANIMALS, AND SUPPLIES
DESCRIBED IN THE RESEARCH PLAN FOR YEAR 1.]
2. Evaluate single agents and/or combination therapies for
efficacy in a mouse model of E. BIENEUSI infection using a
standardized, reproducible, validated therapeutic protocol
defined in Item 1. Upon approval by the Project Officer,
alternative microsporidial models may be substituted.
[NOTE 2 TO OFFEROR: THE FIRST YEAR OF THE CONTRACT WILL FOCUS ON
MODEL DEVELOPMENT AND VALIDATION UNDER ITEM 1 ABOVE; THE GOVERNMENT
ANTICIPATES EFFICACY TESTING WILL START AT THE BEGINNING OF YEAR 2
AND CONTINUE FOR THE DURATION OF THE CONTRACT. HOWEVER, PROGRESS
IN ITEM 1 WILL BE MONITORED CLOSELY AND THE PROJECT OFFICER WILL
DETERMINE THE EXTENT TO WHICH COMPOUND TESTING WILL BE DONE WITH
EITHER THE PRIMARY E. BIENEUSI MODEL OR AN ALTERNATIVE VALIDATED
MODEL USING ANOTHER SPECIES OF MICROSPORA.
THE OFFEROR SHOULD HAVE AVAILABLE AT THE TIME OF PROPOSAL A
SUITABLE ALTERNATIVE MODEL AND PROTOCOL FOR TESTING NEW THERAPIES
AGAINST ANOTHER, APPROPRIATE MICROSPORA SPECIES, SUCH AS
ENCEPHALITOZOON INTESTINALIS. THE SELECTION OF THE ALTERNATIVE
ORGANISM MUST BE JUSTIFIED BY A DISCUSSION OF ITS BIOLOGICAL
RELEVANCE TO E. BIENEUSI STUDIES. THE ALTERNATIVE MODEL SHOULD HAVE
THE MINIMUM REQUIREMENTS DESCRIBED IN 1A-E ABOVE, AND WILL BE USED
AS REQUESTED BY THE PROJECT OFFICER IN PLACE OF THE PRIMARY E.
BIENEUSI MODEL FOR TESTING THERAPIES DURING YEARS 2-5. SUITABILITY
OF THE PROPOSED ALTERNATIVE MODEL WILL BE BASED ON FEASIBILITY,
REPRODUCIBILITY, BIOMEDICAL RELEVANCE TO HUMAN INFECTION,
IDENTIFICATION OF A POSITIVE CONTROL, TESTING CAPACITY, AND
PRACTICALITY. PROTOCOLS SHOULD BE DESIGNED FOR TREATMENT OF AN
ESTABLISHED INFECTION AND INCLUDED IN THE TECHNICAL PROPOSAL.
THE OFFEROR SHOULD PROVIDE DOCUMENTATION OF THE METHODS THAT WILL
BE EMPLOYED TO CONFIRM THE MICROBIOLOGICAL PURITY OF THE
EXPERIMENTAL INFECTION AND THE ABSENCE OF OTHER PATHOGENIC
MICROORGANISMS. THE PROPOSED MODEL SHOULD APPROXIMATE THE CLINICAL
MANIFESTATIONS OF THE INFECTION AS IT OCCURS IN AIDS, OR SHOULD
OTHERWISE HAVE DOCUMENTED UTILITY FOR TESTING DRUG EFFICACY. IN THE
TECHNICAL APPROACH FOR ACCOMPLISHING THE WORK STATEMENT, DISCUSSION
OF POTENTIAL PROBLEMS OF PROPOSED MODELS, AND SUGGESTED SOLUTIONS
SHOULD BE ALSO INCLUDED IN THE TECHNICAL PROPOSAL.
FOR THE PURPOSES OF PREPARING THE BUSINESS PROPOSAL, FOR YEARS 2-5
OF THE CONTRACT, ASSUME THAT 10 SINGLE AGENTS PER YEAR WILL BE
EVALUATED AND THAT EACH EFFICACY EXPERIMENT WILL UTILIZE 6 GROUPS
OF ANIMALS TREATED AS IN THE FOLLOWING EXAMPLE:
O A TEST CANDIDATE COMPOUND AT 3 DOSAGES, ADMINISTERED
TWICE DAILY, FOR A DURATION OF TIME APPROPRIATE TO THE
PROPOSED MODEL;
O A POSITIVE CONTROL GROUP, USING A CLINICAL OR
EXPERIMENTAL THERAPY WITH DEMONSTRATED EFFICACY IN THE
MICROSPORIDIAL MODEL;
O A NEGATIVE CONTROL GROUP, I.E. INFECTED ANIMALS RECEIVING
VEHICLE INSTEAD OF THERAPY;
O A TOXICITY CONTROL GROUP, I.E. UNINFECTED ANIMALS THAT
RECEIVE THE HIGHEST DOSAGE OF DRUG.]
3. Improve, standardize and validate a proposed IN VITRO system
to test new therapies against E. BIENEUSI.
This evaluation system shall include the following minimum
requirements:
a. Quantitative methods that correlate with parasite
numbers, can assess parasite viability, and that
detect statistically significant differences between
experimental groups and test concentrations;
b. A drug or other proposed therapy that will
inhibit IN VITRO growth and is suitable for use
as a positive control;
c. A system or method to compare susceptibility of
other pathogenic microsporidia to an experimental
therapy, including parasite isolates from humans,
when requested; and.
d. At least two quantifiable measures of
cytotoxicity to mammalian cells due to the
experimental therapy.
[NOTE 3 TO OFFEROR: THE OFFEROR SHOULD PROPOSE A CANDIDATE IN VITRO
SYSTEM, THAT COULD BE FURTHER DEVELOPED FOR EVALUATION OF
THERAPIES AGAINST E. BIENEUSI INFECTION. THE OFFEROR SHOULD SUBMIT
A DETAILED RESEARCH PLAN AND TIMELINE FOR ACHIEVING AN IN VITRO
MODEL OF E. BIENEUSI INFECTION AND TESTING PROTOCOL WITH THE ABOVE
CHARACTERISTICS (1A-D). THE RESEARCH PLAN SHOULD DESCRIBE WHAT
EXPERIMENTS THE OFFEROR INTENDS TO CONDUCT IN ORDER TO DEVELOP,
STANDARDIZE AND VALIDATE THE IN VITRO MODEL, INCLUDING THE
IDENTIFICATION OF AN AGENT THAT CAN BE USED AS A POSITIVE CONTROL
IN EFFICACY EVALUATIONS, AND SHOW HOW WORK WILL BE PHASED TO
COMPLETE INITIAL STANDARDIZATION AND VALIDATION OF THIS MODEL AND
PROTOCOL BY THE END OF YEAR 1. OFFERORS SHOULD CLEARLY IDENTIFY THE
YEAR 1 RESEARCH PLAN IN THE TECHNICAL PROPOSAL AND DOCUMENT A
RELIABLE SOURCE OF PARASITE MATERIAL FOR THIS WORK. BECAUSE THE
EMPHASIS OF THIS RFP IS ON E. BIENEUSI, OFFERORS SHOULD PROPOSE IN
VITRO TEST SYSTEMS THAT ARE SPECIFIC TO THAT ORGANISM. IN THE
TECHNICAL APPROACH FOR ACCOMPLISHING THE WORK STATEMENT, DISCUSSION
OF POTENTIAL PROBLEMS OF PROPOSED MODELS, AND SUGGESTED SOLUTIONS
SHOULD BE ALSO INCLUDED IN THE TECHNICAL PROPOSAL.
FOR THE PURPOSES OF PREPARING THE BUSINESS PROPOSAL FOR YEAR 1, THE
OFFEROR SHOULD BE SPECIFIC IN DESCRIBING RESEARCH COSTS AS THEY
RELATE TO THE RESEARCH PLAN IN TERMS OF NUMBERS OF EXPERIMENTS,
CELL LINES, REAGENTS, ETC. ]
4. Screen single agents and/or combinations for efficacy against
E. BIENEUSI using a standardized, reproducible, and validated
IN VITRO system defined and developed in Item 3 above. Upon
approval of the Project Officer, an alternative validated IN
VITRO model using another microsporidial species may be used.
[NOTE 4 TO OFFEROR: THE FIRST YEAR OF THE CONTRACT WILL FOCUS ON IN
VITRO MODEL DEVELOPMENT AND VALIDATION UNDER ITEM 3 ABOVE; THE
GOVERNMENT ANTICIPATES THAT EFFICACY TESTING WILL START AT THE
BEGINNING OF YEAR 2 AND CONTINUE FOR THE DURATION OF THE CONTRACT.
HOWEVER, PROGRESS IN ITEM 3 WILL BE MONITORED CLOSELY AND THE
PROJECT OFFICER WILL DETERMINE THE EXTENT TO WHICH COMPOUND TESTING
WILL BE DONE WITH EITHER THE PRIMARY E. BIENEUSI MODEL OR AN
ALTERNATIVE VALIDATED MODEL USING ANOTHER SPECIES OF MICROSPORIDIA.
THE OFFEROR SHOULD HAVE AVAILABLE AT THE TIME OF PROPOSAL A
SUITABLE ALTERNATIVE IN VITRO MODEL AND PROTOCOL FOR TESTING NEW
THERAPIES AGAINST ANOTHER, APPROPRIATE MICROSPORA SPECIES, SUCH AS
ENCEPHALITOZOON INTESTINALIS. THE SELECTION OF THE ALTERNATIVE
ORGANISM SHOULD BE JUSTIFIED BY A DISCUSSION OF ITS BIOLOGICAL
RELEVANCE TO E. BIENEUSI STUDIES. THE ALTERNATIVE MODEL SHOULD HAVE
THE MINIMUM REQUIREMENTS DESCRIBED IN ITEM 3. A-D ABOVE, AND WILL
BE USED AS REQUESTED BY THE PROJECT OFFICER IN PLACE OF THE PRIMARY
E. BIENEUSI MODEL FOR TESTING THERAPIES DURING YEARS 2-5.
SUITABILITY OF THE PROPOSED ALTERNATIVE MODEL WILL BE BASED ON
FEASIBILITY, REPRODUCIBILITY, BIOMEDICAL RELEVANCE TO HUMAN
INFECTION, IDENTIFICATION OF A POSITIVE CONTROL, TESTING CAPACITY,
AND PRACTICALITY. PROTOCOLS SHOULD BE DESIGNED FOR TREATMENT OF AN
ESTABLISHED INFECTION AND INCLUDED IN THE TECHNICAL PROPOSAL.
FOR THE PURPOSES OF PREPARING THE BUSINESS PROPOSAL, ASSUME 35
THERAPIES WILL BE TESTED PER YEAR AND THAT EACH EXPERIMENT WILL
REQUIRE THE FOLLOWING:
O 4 CONCENTRATIONS OF TEST DRUG,
O ONE NEGATIVE CONTROL GROUP USING DRUG VEHICLE ONLY,
O ONE POSITIVE CONTROL GROUP, AND
O A GROUP FOR ASSESSING CYTOTOXICITY TO MAMMALIAN CELLS
USING AT LEAST TWO QUANTITATIVE METHODS. ]
5. With pre-approval from the Project Officer, continue to
improve and validate models and protocols for microsporidial
infection IN VITRO and IN VIVO for evaluating therapies
against E. BIENEUSI (or an appropriate alternative species).
[NOTE 5 TO OFFEROR: BECAUSE THE GOVERNMENT DOES NOT KNOW IF OR WHAT
MODIFICATIONS ARE LIKELY TO BE NEEDED, THIS SECTION SHOULD NOT BE
CONSIDERED AS PART OF THE BUSINESS PROPOSAL. IT IS EXPECTED THAT
ANY NECESSARY MODIFICATIONS OF THE MODEL SYSTEM WILL NOT INCREASE
THE NEGOTIATED CONTRACT COST, BUT THAT EXISTING RESOURCES WILL BE
REDIRECTED TO ACCOMPLISH THIS TASK. HOWEVER, THE OFFEROR SHOULD
DOCUMENT IN THE TECHNICAL PROPOSAL THEIR QUALIFICATIONS, EXPERTISE,
AND ABILITY TO MODIFY MODELS OR DEVELOP NEW MODELS.]
6. Utilize these models, when directed by the Project Officer,
for specialized studies such as testing therapies with
alternative protocols, e.g., using other microsporidial
species, alternate routes of infection, prophylaxis protocols,
or alternate host cell lines.
[NOTE 6 TO OFFEROR: BECAUSE THE GOVERNMENT DOES NOT KNOW IF OR WHAT
SPECIALIZED STUDIES ARE LIKELY TO BE NEEDED, THIS SECTION SHOULD
NOT BE CONSIDERED AS PART OF THE BUSINESS PROPOSAL. IT IS EXPECTED
THAT ANY WORK CONDUCTED UNDER THIS ITEM WILL NOT INCREASE THE
NEGOTIATED CONTRACT COST, BUT THAT EXISTING RESOURCES WILL BE
REDIRECTED TO ACCOMPLISH THIS TASK. HOWEVER, THE OFFEROR MUST
DOCUMENT IN THE TECHNICAL PROPOSAL THEIR QUALIFICATIONS, EXPERTISE,
AND ABILITY TO CONDUCT ORIGINAL RESEARCH ON MICROSPORIDIA,
INCLUDING PUBLICATIONS.]
7. As requested by the Project Officer, provision shall be made
to obtain and preserve samples of purified organisms or animal
tissues and fluids. Samples shall be sent, as directed, to
another laboratory for storage or for additional experiments
and analyses on the samples. The Contractor shall cooperate or
collaborate with other investigators as requested and shall
conform to federal safety regulations on shipping biohazardous
materials.
[NOTE 7 TO OFFEROR: FOR THE PURPOSES OF PREPARING THE BUSINESS
PROPOSAL, THE OFFEROR SHOULD ASSUME THAT 4 SHIPMENTS OF PURIFIED
PARASITE MATERIAL AND 10 SHIPMENTS OF INFECTED ANIMAL TISSUES OR
FLUIDS PER YEAR WILL BE SENT TO BETHESDA, MD.]
8. The Contractor shall submit quarterly reports during the
initial development phase of the Contract documenting progress
made in the proposed IN VITRO and animal model systems to
improve the suitability of these systems for evaluating new
therapies. The Contractor shall report compound test data
generated under this Contract to the Project Officer in the
form of interim progress reports at the completion of each
protocol, and in semi-annual reports as described in the
section entitled, "Reporting Requirements". In order to
facilitate timely transmission of data and information, the
Contractor shall establish and maintain a secure, efficient
data management system including electronic mail with the
Project Officerþs office. The Contractor shall insure that no
identifiable data on the compounds and the results of testing
will be kept in files open to the public, and the facilities
for computer operation, data entry, and file storage are
secure from unauthorized access.
[NOTE 8 TO OFFEROR: FOR THE PURPOSES OF PREPARING THE BUSINESS
PROPOSAL, ASSUME THE FOLLOWING REPORTS WILL BE REQUIRED:
O FOUR QUARTERLY REPORTS IN YEAR 1
O TWO SEMI-ANNUAL REPORTS PER YEAR FOR YEARS 2-5
O SIX INTERIM REPORTS PER YEAR DURING YEARS 2-5
THE OFFEROR SHOULD ASSUME FOUR HARD COPIES AND ONE MAGNETIC
DISKETTE COPY OF EACH REPORT WILL BE SENT AS DESCRIBED IN THE
SECTION þREPORTING REQUIREMENTSþ OF THIS RFP.]
9. The Contractor shall provide to the Project Officer draft
copies of manuscripts for publication including abstracts and
oral presentations based on data generated under this
Contract, and obtain clearance before submitting for
publication or presentation. Support from the Government
Contract must be acknowledged. The Contractor shall be bound
by the same terms as the Government under the Screening and
Confidentiality Agreement used by the Division of AIDS. (A
copy is appended).
10. The Contractor shall conduct work under this contract in
accordance with the following basic references and all related
modifications and updates by the Centers for Disease Control
and Prevention/NIH and state, Federal, and local regulations.
a. Biosafety in Microbiological and Biomedical Laboratory,
published by CDC, third edition, May 1993.
b. Guide for the Care and Use of Laboratory Animals, NIH
Publication No. 86-23, Revised 1985.
c. All etiologic agents, blood, and tissue samples shipped
under this contract shall be packaged, marked and shipped
in accordance with the "Interstate Shipment of Etiologic
Agents (42 CFR, Part 72)" revised July 21, 1980 which
provides for packaging and labelling requirements for
etiologic agents and certain other materials shipped in
interstate traffic. The Contractor shall guarantee that
all required materials shall be delivered in immediate
usable and acceptable condition.
[NOTE 9 TO OFFEROR: SEE ATTACHMENT 4 FOR THE PHS SAFETY AND HEALTH
CLAUSE WHICH WILL BECOME PART OF ANY RESULTANT CONTRACT. A COPY OF
THE GUIDE FOR B. ABOVE MAY BE OBTAINED FROM THE INSTITUTE OF
LABORATORY ANIMAL RESOURCES, NATIONAL RESEARCH COUNCIL, 2101
CONSTITUTION AVENUE, N.W., WASHINGTON, D.C. 20418, TELEPHONE (202)
334-2000. INFORMATION ON THE REGULATION FOR C. ABOVE MAY BE
OBTAINED FROM THE CDC BIOHAZARD CONTROL OFFICER, 1600 CLIFTON ROAD,
ATLANTA, GA, 30333, TELEPHONE (404) 639-3883.]
11. By the end of the fourth year, the Contractor shall have
developed and submitted a plan or written procedures for an
orderly transition of data and samples to a subsequent
Contractor or to the Government, subject to Project Officer
approval, and shall deliver, if requested by the Project
Officer and by the completion date of the Contract, the
following items: accurate and updated protocols and
databases, original data, preserved strains, samples, and any
necessary information related thereto.
12. The Contractþs Principal Investigator and key personnel
shall meet with the Project Officer at periodic
intervals, to be scheduled after Contract award, to
review progress, anticipated or existing problems, and
discuss the work to be performed. At least one of the
Contractorþs key personnel must attend and present
information, at the direction of the Project Officer, on
therapies evaluated under the Contract at one NIAID-
sponsored meeting per year.
[NOTE 10 TO OFFEROR: FOR THE PURPOSE OF PREPARING A BUSINESS
PROPOSAL, ASSUME 2 VISITS OF ONE KEY PERSONNEL PER YEAR TO 6003
EXECUTIVE BLVD, 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.
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-02
ATTACHMENT 2
4/15/96
DELIVERABLES AND REPORTING REQUIREMENTS
---------------------------------------
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. INTERIM PROGRESS REPORTS
The Contractor shall submit interim progress reports on
magnetic media (3.5 inch diskettes) as computer files using
software compatible with that of the Government, (e.g.
Microsoft Word (TM) ver. 6.0 for Windows or WordPerfect 6.1
for Windows and Microsoft Excel (TM) ver. 5.0 for Windows, to
determined by the Project Officer), formats readable using an
IBM-type personal computer, within 21 calendar days of the
completion of each protocol or evaluation conducted under Work
Statements 1 to 6 to the Project Officer. Four hard copies of
each report will also be provided as described below (E.
Technical Reports Distribution). The Project Officer may
approve alternate forms of transmittal of Interim Reports
(such as via modem). It remains the responsibility of the
Contractor to assure receipt by the Project Officer of all
reports by the established due dates. The Project Officer may
require responses to electronic mail described in Work
Statement 6. Interim Progress reports shall include the
following:
1. Cover page containing:
a. Contract number and title;
b. Period of performance being reported;
c. Contractor's name and address;
d. Author (s);
e. Date of submission; and
f. Interim Progress Report number.
2. Background: purpose of experiment, summary of
available information on each therapy which was
considered in designing the protocol, chemical
structures of compounds tested (if known), and brief
description of known biological activity.
3. Study protocol design.
4. Report of results and data from study including
tables, graphs, and statistical analyses.
5. Interpretation and brief discussion of data, based
on literature and other studies done under Contract,
and recommendations for further development or
testing of the therapy.
The Contractor shall retain the original data obtained under
the Contract. The Contractor shall furnish these original
data or copies or photographs thereof if requested by the
Project Officer.
B. QUARTERLY AND SEMI-ANNUAL PROGRESS REPORTS
The Contractor shall submit four paper copies of each
quarterly progress report during the development phase of the
Contract, and four copies of each semi-annual report during
the testing phase of the Contract AND one copy on magnetic
media (3.5 inch, high density diskettes) as computer files
using software compatible with the Government (e.g. Microsoft
Word (TM), Version 6.0 or WordPerfect 6.1 for Windows and
Microsoft Excel (TM) Version 5.0, to be determined by the
Project Officer), formats readable using an IBM-compatible
personal computer. It remains the responsibility of the
Contractor to assure receipt by the indicated government
official listed below of all reports by the established due
dates. Reports shall include the following specific
information:
a. A cover page containing:
1. Contract number and title;
2. Period of performance being reported;
3. Contractor's name and address;
4. Author(s);
5. Date of submission; and
6. Semi-Annual Progress Report number.
b. A Table of Contents listing each experiment with page
numbers for each section.
c. SECTION A: A CONCISE, narrative description of the work
performed during the reporting period and the anticipated
work plan for the following six months.
d. SECTION B: A chronological listing of evaluations
performed during the reporting period (supported by
reference to the data contained within the Interim
Progress Reports described in A), in sufficient detail to
identify the protocol employed, significant results, and
conclusions. Conclusions from statistical analyses and
scientific comparisons of data to previous studies
conducted under the Contract and to studies in the
published literature shall be included in a concise
format.
e. SECTION C: Tables of therapies studied during the
reporting period IN VITRO and IN VIVO, and tables
containing cumulative listings of drugs or therapies
studied IN VITRO and IN VIVO during the entire Contract.
These should be presented in separate tables and include
the name of the therapy (in alphabetical order),
concentrations or doses tested, the test system, a
concise indication of the relative activity, and the date
and number of the Interim Progress Report containing the
complete data.
f. SECTION D: A brief discussion of problems encountered,
their resolution or proposed corrective action, and an
explanation of any differences between planned progress
and actual progress.
g. SECTION E: Copies of manuscripts, abstracts, or
presentations (published or unpublished) derived from
research under the Contract during the reporting period,
and a cumulative list of publications derived from
research under the Contract.
Semi-Annual progress reports are not due for the period in
which the final report falls due.
C. OTHER DELIVERABLES.
The Contractor, subject to Project Officer approval shall deliver
to the Government or its designee by the expiration date of the
Contract, the following items (with the exception of item (4) which
shall be delivered by the end of the fourth year):
(1) A computer-generated listing of accurate and updated
information on compound inventory, including activities
of the Contractor, data files, original data and any
necessary information related thereto;
(2) Labeled and inventoried paper files;
(3) Any other government-owned property; and
(4) The transition plan required in Work Statement #9.
D. FINAL REPORT
The Contractor shall submit four hard copies of the final
report and one copy on magnetic media that provides a summary
of the work accomplished since the last semi-annual report and
the work accomplished during the entire Contract period. The
final report shall be submitted by the completion date of the
Contract. A separate semi-annual progress report will not be
required for the period when the final report is due. Final
reports shall follow the format described above.
E. TECHNICAL REPORTS DISTRIBUTION
Copies of the written technical reports shall be submitted as
follows:
Type of No. of
REPORT COPIES ADDRESSEE DUE DATES
______ ______ _________ _________
Progress 3* Project Officer quarterly,
OIRB, TRP, Div. AIDS semi-annual
Solar Bldg, Rm. 2C24
6003 Executive Boulevard (MSC 7620)
Bethesda, MD 20892-7620
Progress 1 Contracting Officer quarterly,
ACRCS, CMB, DEA, NIAID semi-annual
Solar Bldg., Rm. 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Interim 3* Same as P.O. above within 21
calendar days of
the completion
of each protocol
or evaluation
conducted under
Work items 1 - 6
Interim 1 Same as C.O. above within 21
calendar days of
the completion
of each protocol
or evaluation
conducted under
Work items 1 - 6
Final 3* Same as P.O. above by expiration
date
Final 2 Same as C.O. above by expiration
date
(*Note: the Project Officer also receives a copy of each of the
reports above on a 3.5 inch diskette.)
If the Contractor becomes unable to deliver the reports specified
hereunder within the period of performance because of unforeseen
difficulties, notwithstanding the exercise of good faith and
diligent efforts in performance of the work, the Contractor shall
give the Contracting Officer immediate written notice of
anticipated delays with reasons therefor.
E. Other Deliverables. The Contractor, subject to Project
Officer approval shall deliver to the Government or its
designee by the expiration date of the Contract, the following
items (with the exception of item (4) which shall be delivered
by the end of the fourth year):
(1) A computer-generated listing of accurate and updated
information on compound inventory, including activities
of the Contractor, data files, original data and any
necessary information related thereto;
(2) Labeled and inventoried paper files;
(3) Any other government-owned property; and
(4) The transition plan required in Item #11 of the Work
Statement.
F. Level of Effort
The Government's requirement for the work set forth in the
Work Statement of this solicitation is 1,750% direct labor
effort. It is estimated that the labor effort is constituted
as specified below and will be expended approximately as
follows:
Labor Effort* 5 YR
Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 TOTAL
--------------------------------------------------------------
Professional 65% 65% 65% 65% 65% 325%
Support 285% 285% 285% 285% 285% 1,425%
---- ---- ---- ---- ---- ------
TOTAL 350% 350% 350% 350% 350% 1,750%
*EFFORT IN THE ABOVE CHART WAS BASED ON 100% EFFORT = 2,080
HOURS PER YEAR, WHICH INCLUDES HOLIDAYS AND OTHER PAID
ABSENCES. IF YOU ARE USING A DIFFERENT BASE, PLEASE STATE THE
WORK YEAR USED IN YOUR PROPOSAL. THE ABOVE LEVEL OF EFFORT IS
THE GOVERNMENT'S ESTIMATE OF THE EFFORT THAT WILL BE NECESSARY
TO SATISFACTORILY ACCOMPLISH THE OBJECTIVE OF THESE STUDIES,
AND IT WILL BE USED AS A BASIS FOR NEGOTIATIONS. HOWEVER, YOU
CAN PROPOSE DEVIATIONS FROM THIS ESTIMATED LEVEL OF EFFORT,
WITH JUSTIFICATION.
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-02
ATTACHMENT 3
4/15/96
EVALUATION FACTORS FOR AWARD
----------------------------
PROPOSAL EVALUATION CRITERIA
The technical portion of the proposal will be the most important
single consideration in the award of the Contract and should,
therefore, be as complete and specific as possible. The merits of
each proposal will be carefully evaluated in terms of requirements,
the scientific and administrative capabilities of prospective
Contractors in relation to the needs of the project, and the
reasonableness of the costs shown in relation to this project.
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 rejection of that proposal without further
consideration. In the event that the technical evaluation
identifies two or more Offerors of approximately equal technical
ability, THEN COST SHALL BECOME A FACTOR IN AWARD. In any event the
Government reserves the right to make, or not make, awards to the
best advantage of the Government, cost and programmatic priorities
considered. It is anticipated that one (1) Contract will be
awarded, dependent upon the availability of funds. Award will be
based upon the award criteria in this RFP.
Below are technical evaluation criteria, listed and weighted in
order of their relative importance, which will be used by the
technical evaluation review committee to evaluate technical
proposals submitted in response to this RFP.
PROPOSALS WILL BE JUDGED SOLELY ON THE WRITTEN MATERIAL PROVIDED BY
THE OFFEROR.
TECHNICAL EVALUATION CRITERIA
POINTS
A. TECHNICAL APPROACH TO ANIMAL MODELS 40 PTS
Offerors will be evaluated on the basis of suitability, technical
adequacy, feasibility, and ability to develop alternative
strategies as described in detail in their technical approach.
Specific points of consideration are:
1. QUALITY AND FEASIBILITY OF THE RESEARCH PLAN FOR E. BIENEUSI
MOUSE MODEL DEVELOPMENT, INCLUDING IMPROVING, STANDARDIZING,
AND VALIDATING A PROPOSED MOUSE MODEL OF E. BIENEUSI INFECTION
AND PROTOCOL TO TEST THERAPIES AGAINST ESTABLISHED INFECTIONS.
(25 PTS)
Points to consider include:
o Quality of plans to assess the modelþs reproducibility,
standardization, validation;
o Approximation of the model to the spectrum of clinical
disease seen in AIDS;
o Selection of appropriate, quantitative, unambiguous
indicators and methods to assess morbidity, therapeutic
efficacy, and general toxicity;
o Extent to which a feasible timetable, supported
by detailed plans, convincingly indicates that
the Contract milestones can be achieved;
o Understanding of the limitations of the proposed systems
and adequacy of suggested solutions.
2. AVAILABILITY AND TECHNICAL ADEQUACY OF THE PROPOSED
ALTERNATIVE MODEL AND PROTOCOL UTILIZING AN ALTERNATIVE
SPECIES OF MICROSPORA FOR TESTING NEW THERAPIES. (15 PTS)
Points to consider include:
o Justification for selection including approximation to
the clinical disease seen in AIDS, and the documented
availability of model;
o Selection of appropriate, quantitative, unambiguous
indicators of morbidity, therapeutic efficacy, and
toxicity;
o Suitability, i.e. standardization, reproducibility,
practicality, adequacy of positive control, testing
capacity;
o Quality of validation, data analysis, statistical
approach (e.g. as for an IND application);
o Understanding limitations and potential problems of
alternative model and adequacy of suggested solutions.
.o Quality of research plans to continue
improving, modifying, or further characterizing
the alternative model and the protocol.
B. TECHNICAL APPROACH TO IN VITRO TEST SYSTEMS 30 PTS
1. QUALITY OF RESEARCH PLANS TO DEVELOP, IMPROVE, STANDARDIZE,
AND VALIDATE A PROPOSED IN VITRO SYSTEM TO TEST NEW THERAPIES
AGAINST E. BIENEUSI. (15 PTS)
Points to consider include:
o Quality of plans to develop the proposed system in terms
of suitability and validation criteria;
o Adequacy of selected indicators and methods to assess
efficacy and cytotoxicity;
o Understanding the limitations of the proposed system and
adequacy of suggested solutions;
o Extent to which a feasible timetable, supported
by detailed plans, convincingly indicates that
the Contract milestones can be achieved.
2. QUALITY OF THE PROPOSED IN VITRO TEST SYSTEM AND PROTOCOL
UTILIZING AN ALTERNATIVE SPECIES OF MICROSPORA. (15 PTS)
Points to consider include:
o Justification of selection and documented availability of
test system with demonstrated utility for testing
therapies for microsporidiosis;
o Suitability for testing, i.e. standardization,
reproducibility, practicality, adequacy of positive
control, testing capacity;
o Selection of appropriate, quantitative, unambiguous
indicators of therapeutic efficacy and cytotoxicity;
o Quality of validation, data analysis, statistical
approach (e.g. as for an IND application);
o Quality of research plans to continue
improving, modifying, or further characterizing
the alternative IN VITRO model and the
protocol;
o Understanding limitations and potential problems of the
alternative model and adequacy of suggested solutions.
C. PERSONNEL AND ADMINISTRATIVE FRAMEWORK 20 PTS
1. PRINCIPAL INVESTIGATOR: (10 PTS)
o Relevance and quality of recent work, education,
training, management experience, and documented
availability for the proposed project;
o Past experience with E. BIENEUSI and demonstrated
success in developing models to study microsporidia;
o Demonstrated capability to evaluate therapies and
appropriately modify test systems and protocols.
2. OTHER PERSONNEL AND ADMINISTRATIVE FRAMEWORK.
(10 PTS)
o Relevance and extent of experience of other professional
and research technical and support staff and their
documented capability to conduct proposed studies;
o Logistical adequacy of the staffing plan for the conduct
of the project, including the time commitment and
documented availability of the professional and technical
staff;
o Logistical adequacy of the proposed administrative
framework, including lines of authority and plan
for maintaining quality control over the
implementation and operation of the Contract.
D. FACILITIES AND RESOURCES 10 PTS
o 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 SHOULD be provided.
o Documented source and availability of the animals, the
species and strain(s) of microsporidial parasites, and
specialized reagents described in the technical proposal;
o Documentation of adequate facilities to receive and store
compounds, and maintain their stability. 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.
TOTAL POINTS: 100
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-02
ATTACHMENT 4
4/15/96
II. SPECIFIC RFP INSTRUCTIONS AND PROVISIONS
---------------------------------------------
NOTICE TO OFFERORS: This attachment contains proposal instructions
and information which 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 5,
"Applicable RFP References."
1. SIC CODE AND SMALL BUSINESS SIZE STANDARD (NIH 3150) (JUN
1988)
Note: The following information is to be used by the
Offeror in preparing its Representations and
Certifications (See Attachment 5, item 4. of this RFP.),
specifically in completing the provision entitled, SMALL
BUSINESS PROGRAM REPRESENTATIONS (OCT 1995), FAR 52.219-
1:
(a) The standard industrial classification (SIC) code for
this acquisition is 8733.
(b) (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.
(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.
2. NUMBER AND TYPE OF AWARD(S)(NIH 2980) (APR 1984)
It is anticipated that one (1) award will be made from this
solicitation and that award will be made on or about July 15,
1997.
It is anticipated that the award from this solicitation will
be multiple-year cost reimbursement type level-of-effort
Contract with a period of performance of 5 years, and that
incremental funding will be used [see paragraph (6) of
Business Proposal Instructions, in the "Standard RFP
Instructions and Provisions" of the Gopher RFP].
3. LEVEL OF EFFORT
The Government's requirement for the work set forth in the
Work Statement of this solicitation is 1,750% direct labor
effort. It is estimated that the labor effort is constituted
as specified below and will be expended approximately as
follows:
Labor Effort* 5 YR
Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 TOTAL
--------------------------------------------------------------
Professional 65% 65% 65% 65% 65% 325%
Support 285% 285% 285% 285% 285% 1,425%
---- ---- ---- ---- ---- ------
TOTAL 350% 350% 350% 350% 350% 1,750%
*EFFORT IN THE ABOVE CHART WAS BASED ON 100% EFFORT = 2,080
HOURS PER YEAR, WHICH INCLUDES HOLIDAYS AND OTHER PAID
ABSENCES. IF YOU ARE USING A DIFFERENT BASE, PLEASE STATE THE
WORK YEAR USED IN YOUR PROPOSAL. THE ABOVE LEVEL OF EFFORT IS
THE GOVERNMENT'S ESTIMATE OF THE EFFORT THAT WILL BE NECESSARY
TO SATISFACTORILY ACCOMPLISH THE OBJECTIVE OF THESE STUDIES,
AND IT WILL BE USED AS A BASIS FOR NEGOTIATIONS. HOWEVER, YOU
CAN PROPOSE DEVIATIONS FROM THIS ESTIMATED LEVEL OF EFFORT,
WITH JUSTIFICATION.
4. 52.233-2 SERVICE OF PROTEST (NOV 1988)
(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:
Mr. Bruce Anderson
Hand-Carried Address:
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, Maryland 20852-7610
Mailing Address:
NIH/NIAID
Contract Management Branch
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.
5. PACKAGING AND DELIVERY OF THE PROPOSAL (NIH 2995) (JUL 1994)
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-97-02
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY
Number of Copies:
________________
TECHNICAL PROPOSAL: ORIGINAL AND 20 COPIES
BUSINESS PROPOSAL: ORIGINAL AND 5 COPIES
If hand delivered or delivery service
-------------------------------------
Phillip Hastings
Contract Specialist
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, Maryland 20852-7610
If using U.S. Postal Service
----------------------------
Phillip Hastings
Contract Specialist
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
* 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).
6. PHS 352.223-70 SAFETY AND HEALTH (APRIL 1984)
(a) In order to provide safety controls for protection to the
life and health of employees and other persons; for
prevention of damage to all property; and for avoidance
of work interruptions in the performance of the Contract;
the Contractor will consult, comply with, and include in
all applicable subcontracts, the following standards, as
appropriate:
(1) Biosafety in Microbiological and Biomedical
Laboratories, U.S. Department of Health and Human
Services, Centers for Disease Control (CDC) and the
NIH, HHS Pub. No. (CDC) 93-8395.
(2) Recommendations for Prevention of HIV Transmission
in Health-Care Settings, Morbidity and Mortality
Report, August 21, 1987, Vol. 35, No. 2S.
(3) Update: Universal Precautions for Prevention of
Transmission of Human Immunodeficiency Virus,
Hepatitis B Virus, and Other Bloodborne Pathogens in
Health-Care Settings. Morbidity and Mortality Weekly
Report, June 24, 1988, Vol. 37, No. 24.
(4) Agent Summary Statement for Human Immunodeficiency
Viruses (HIV); Included are GTLV-III, LAV, HIV-1,
and HIV-2. Morbidity and Mortality Weekly Report,
April 1, 1988, Vol. 37, No. S4.
(5) Recommendations for the Safe Handling of Parenteral
Antineoplastic Drugs, NIH Publication No. 83-2621.
(6) NIH Guidelines for the Laboratory Use of Chemical
Carcinogens, NIH Publication No. 81-2385.
The above, (1) - (6), may be obtained from:
Division of Safety
Office of Research Services
National Institutes of Health
Building 31, Room 1CO2
31 CENTER DR MSC 2260
BETHESDA, MARYLAND 20892-2260
(7) Guidelines for Research Involving Recombinant DNA
Molecules (49 FR 46266 or latest revision) and
Administrative Practices Supplement. These may be
obtained from:
Office of Recombinant DNA Activities
Office of Science Policy and Legislation
National Institutes of Health
Building 31, Room B1C34
31 CENTER DR MSC 2250
BETHESDA, MARYLAND 20892-2250
(8) Procedures for the Domestic handling and Transport
of Diagnostic Specimens and Etiologic Agents,
National Committee for Clinical Laboratory
Standards, July 17, 1985, Vol. 5. This may be
obtained from:
National Committee for Clinical
Laboratory Standards
771 East Lancaster Avenue
Villanova, Pennsylvania 19085
Further, the Contractor shall take or cause to be taken
such additional safety measures as the Contracting
Officer may determine to be reasonably necessary;
Provided, that if compliance with such additional safety
measures results in a material increase in the cost or
time of performance of the Contract, an equitable
adjustment will be made in accordance with the clause of
this Contract entitled "Changes."
(b) Prior to commencement of work, the Contractor will submit
in writing its plan for complying with the safety and
health provisions of this Contract, and will meet with
the Contracting Officer or his/her designated
representative to discuss and develop a mutual
understanding relative to administration of the overall
safety program.
(c) During the performance of work under this Contract, the
Contractor shall comply with all procedures prescribed by
the Contracting Officer for the control and safety of
persons visiting the job site and will comply with such
requirements to prevent accidents as may be prescribed by
the Contracting Officer.
(d) The Contractor will maintain an accurate record of, and
report to the Contracting Officer in such manner as the
Contracting Officer may prescribe, all accidents and
incidents resulting in death, traumatic injury,
occupational disease, and/or damage to all property
incident to work performed under the Contract.
(e) The Contracting Officer shall notify (if otherwise,
confirm in writing) the Contractor of any noncompliance
with the provisions of this clause and corrective action
to be taken. After receipt of such notice, the
Contractor shall immediately take such corrective action.
(Such notice, when delivered to the Contractor or its
representative at the site of the work, shall be deemed
sufficient for the purpose.) If the Contractor fails or
refuses to comply promptly, the Contracting Officer may
issue an order stopping all or part of the work until
satisfactory corrective action has been taken. No part
of the time lost due to any such stop order shall be the
subject of claim for extension of time or for costs or
damages by the Contractor.
(f) The Contractor shall insert the substance of this clause
in each subcontract involving the use of hazardous
materials or operations. Compliance with the provisions
of this clause by subcontractors will be the
responsibility of the Contractor.
7. 52.227-6 ROYALTY INFORMATION(APR 1984)
(a) Cost or charges for royalties. When the response to this
solicitation contains costs or charges for royalties
totaling more than $250, the following information shall
be included in the response relating to each separate
item of royalty or license fee:
(1) Name and address of licensor.
(2) Date of license agreement.
(3) Patent numbers, patent application serial numbers,
or other basis on which the royalty is payable.
(4) Brief description, including any part or model
numbers of each Contract item or component on which
the royalty is payable.
(5) Percentage or dollar rate of royalty per unit.
(6) Unit price of Contract item.
(7) Number of units.
(8) Total dollar amount of royalties.
(b) Copies of current licenses. In addition, if specifically
requested by the Contracting Officer before execution of
the Contract, the Offeror shall furnish a copy of the
current license agreement and an identification of
applicable claims of specific patents.
8. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT
(NOTE: INSTRUCTIONS TO OFFERORS ARE INDICATED IN PARENTHESES
OR AS FOOTNOTES.)
SECTION # PAGE #
--------- ------
1. TECHNICAL PROPOSAL COVER SHEET (Format in Section C
of Gopher RFP: FORMS, FORMATS, ATTACHMENTS) ............. 1
2. TECHNICAL PROPOSAL TABLE OF CONTENTS .................... 2
3. SUMMARY OF OBJECTIVES AND METHODS* ...................... 3
4. TECHNICAL PLAN** (Refer to Technical Proposal Instructions,
Section C.1., Standard RFP Instructions and Provisions,
Gopher RFP for more detail)
a. WORK STATEMENT
1. Objectives ...................................... 4
2. Approach .......................................____
3. Methods ........................................____
4. Schedule .......................................____
b. RESOURCES AND DIRECT COSTS (list/describe all equip-
ment, facilities and other resources available for
this project; attach "Technical Proposal Cost
Information" form, and marked laboratory floor plan
in Section 6, below)...............................____
c. PERSONNEL (List by name, title, department and
organization, and detail each person's qualifications
and role in the Project); provide narrative for:
1. Principal Investigator/Project Director ........____
2. Other Investigators ............................____
3. Additional Personnel (technical support/
subcontractors/consultants) .......................____
Note: For personnel, include resumes and the form
entitled "Summary of Current and Proposed Activities"
under Sections 5 and 6 below.
d. OTHER CONSIDERATIONS (provide brief narrative
of any unique arrangements, safety procedures
in place, animal welfare issues etc.)..............____
5. APPENDICES (Literature citations, Protocols, Resumes
policy manuals, etc. for above Technical Plan); list
each Appendix; Appendices must be clear and legible,
and easily located......................................____
6. OTHER ATTACHMENTS:
a. "Summary of Current and Proposed Activities" (All
key personnel must be listed on this form; it is
located in the FORMS, FORMATS, ATTACHMENTS
Directory found in Section C, Gopher RFP)..........____
b. "Technical Proposal Cost Information" form (located
in Section C, Gopher RFP, FORMS, FORMATS, &
ATTACHMENTS).......................................____
c. Laboratory Design and Floor Plan (clearly indicate
the space available for this Project)............ .____
*State the proposal's broad, long-term objectives and specific
aims. Briefly and concisely describe the research design and
methods for achieving these goals (limit to one page).
** Sections 4.a. through 4.d. above MUST NOT EXCEED 50 PAGES (this
does not include copies of resumes and any required forms, but only
the NARRATIVE description of the Technical Plan). The front side
of a page equals one page (front and back of a page equals two
pages). Type density and size must be 10 to 12 points. If
constant spacing is used, there should be no more than 15 cpi,
whereas proportional spacing should provide an average of no more
than 15 cpi. There must be no more than six lines of text within a
vertical inch.
***********************************************************
9. PROPOSAL INTENT RESPONSE SHEET
PROPOSAL INTENT
---------------
RFP No.:NIH-NIAID-DAIDS-97-02
PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE
INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE EARLIEST
PRACTICABLE DATE. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT
WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.
__________________________________________________________________
[] DO INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING:
____________________________________________________
____________________________________________________
[] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING
REASONS:
____________________________________________________
TYPED NAME AND TITLE: ______________________________
INSTITUTION:________________________________________
SIGNATURE:__________________________________________
TELEPHONE NO.:______________________________________
DATE: ______________________________________________
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
COLLABORATORS/CONSULTANTS - Provide name(s) and institution(s):
(Continue list on reverse if necessary)
________________________________________________________________
________________________________________________________________
RETURN TO: CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
Attn: Phillip Hastings
RFP NIH-NIAID-DAIDS-97-01
Fax # 301/402-0972
PLEASE RETURN BY JULY 15, 1996
***********************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-02
ATTACHMENT 5
4/15/96
III. APPLICABLE RFP REFERENCES
-------------------------------
This section identifies the items located in the Gopher directory
"C. RFP REFERENCES" that are applicable to this RFP.
1. The entire file entitled "STANDARD RFP INSTRUCTIONS AND
PROVISIONS" is applicable to this RFP, except as otherwise may
be modified by the inclusion of an item from the "OPTIONAL RFP
INSTRUCTIONS AND PROVISIONS".
2. The following items are applicable from the file entitled"
OPTIONAL RFP INSTRUCTIONS AND PROVISIONS":
(1) LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND
WITHDRAWALS OF PROPOSALS, PHS 352.215-10
(2) NOTICE TO OFFERORS OF REQUIREMENT FOR ADEQUATE ASSURANCE
OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS (SEP 1985),
PHSAR 352.280-2(a)
(3) SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS
SUBCONTRACTING PLAN [NOTE: A Subcontracting Plan is not
due with the initial proposal. The Contracting Officer
will notify Offerors if a plan becomes due.]
3. The following items are applicable from the subdirectory
entitled "FORMS, FORMATS, AND ATTACHMENTS":
Applicable to Technical Proposal
--------------------------------
(1) Technical Proposal Cover Sheet
(2) Technical Proposal Cost Information, Dec 1988
(3) Summary of Current and Proposed Activities, July 1995
Applicable to Business Proposal
-------------------------------
(4) Contract Pricing Proposal, SF-1411, (Rev. 10/95)
(5) Proposal Summary and Data record, NIH-2043 (Rev. 6/82)
(6) Business Proposal Cost Information
(7) Disclosure of Lobbying Activities, OMB SF-LLL
To Become Contract Attachments
------------------------------
(8) Invoice/Financing Requests Instructions for NIH Cost-
Reimbursement Type Contracts, NIH(RC)-1, JUN 1992
(9) Instructions for Completing Form NIH 2706 (Financial
Report
(10) Procurement of Certain Equipment, NIH(RC)-7
Other - to be submitted as directed by Contracting Officer
----------------------------------------------------------
(11) Certificate of Current Cost or Pricing Data, NIH-1397
(12) Subcontracting Plan Format
4. The Representations and Certifications are applicable.
5. The "Sample Contract Format-General" is applicable.
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-02
ATTACHMENT 6
4/15/96
IV. AGREEMENT FOR SUBMITTING PRODUCTS TO THE DIVISION OF AIDS
[SAMPLE]
SCREENING AGREEMENT FOR SUBMITTING PRODUCTS TO THE DIVISION OF
ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, HEREAFTER REFERRED TO AS
THE DIVISION,
BY
_____________________________________________________________,
HEREAFTER REFERRED TO AS THE SUPPLIER.
1. The SUPPLIER may supply products, patented or unpatented, to
the DIVISION which may proceed to screen and test for possible
treatment for AIDS and associated opportunistic infections
including tuberculosis. These products are 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 AIDS and
associated infections, and for no other purpose.
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,
or in any other testing laboratories which may from time to
time be added to the DIVISION's portfolio but in any event
will not be placed in the laboratories of any company in the
pharmaceutical or chemical industries without the SUPPLIER's
written permission.
2. In order to facilitate records keeping and handling of
confidential materials, the DIVISION utilizes the following
procedures:
a. The SUPPLIER shall forward to the [INSERT BRANCH NAME] of
the DIVISION the products to be tested together with data
sheets in duplicate for each product, giving pertinent
available data as to chemical constitution, solubility,
toxicity, previous biological efficacy and any
precautions which need to be followed in handling,
storing, and shipping.
b. It is clearly understood that no data about the products
and the results of the testing will be kept in files open
to the public either by the DIVISION, the testing
laboratories, or the data processing activities. 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
[SAMPLE]
results of testing, except as required pursuant to the
Freedom of Information Act, 5 U.S.C.552.
c. Whenever possible the SUPPLIER will be given the choice
of the DIVISION's Contract testing laboratories, although
at present there is no preference; and it is understood
that the DIVISION reserves the right to send the
SUPPLIER's products to another screening Contractor if
the need arises. It is furthermore understood that the
Contracts between the DIVISION and the testing
laboratories will contain provisions to safe guard 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 academic collaborators, as well as
the SUPPLIER's own staff, the DIVISION will work in
concert to assure rapid ongoing communications of
screening data to the SUPPLIER, and the SUPPLIER will in
turn use its best efforts to keep the DIVISION informed
on the SUPPLIER's own ongoing concomitant studies.
3. Although the SUPPLIER recognizes that the interchange of
information is generally desirable in the field of treatment
for AIDS, 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
compounds or products in which the SUPPLIER has a
proprietary interest. The SUPPLIER understands that
Contractors have the right to elect to retain title to
inventions made under NIAID-supported Contracts [37 CFR
401.14(b)]. The SUPPLIER deserves the right to reach an
agreement with these Contractors concerning the
disposition of these intellectual property rights. The
DIVISION agrees to notify the SUPPLIER of the names of
the Contractors prior to submitting compounds or products
to them.
[SAMPLE]
Subject notwithstanding, to the provision that, with
respect only to those drugs which have been
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 which the SUPPLIER
may have or obtain on such compound or product or on
a process for use of such compound or 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 or connected
with the treatment of AIDS and associated infections
including tuberculosis.
b. The DIVISION agrees that the publication of biological
data on products provided by the SUPPLIER is worthwhile
and shall be encouraged. Specifically:
(1) With regard to screening results on compounds in
which the SUPPLIER has a proprietary interest, and
that the DIVISION deems significant for the research
on therapies for AIDS and associated infections
including tuberculosis, the SUPPLIER agrees that the
DIVISION may publish or otherwise publicly disclose
such results after a period of 6 months from the
date of final reporting of screening and testing
results to the SUPPLIER in order for patent
applications to be filed. The DIVISION will consult
with the SUPPLIER prior to publication within this
period on screening and testing results.
(2) For all other compounds, the SUPPLIER will consult
with the DIVISION prior to publishing screening data
along with the available biological and physical
data; such consent shall not be unreasonably
withheld.
(3) In no case will the DIVISION publish information
identifying the SUPPLIER as the source of the
compound without written approval.
[SAMPLE]
c. As soon as tests are completed and reported to the
[INSERT BRANCH NAME] of the DIVISION, the SUPPLIER will
receive from the DIVISION a full report including all
screening data.
The products scheduled for clinical trial, referred to
herein, shall be designated by the DIVISION, and the
aforementioned report will specify the compounds so
selected. The [INSERT BRANCH NAME] of the DIVISION shall
be consulted whenever the SUPPLIER desires to include
screening data in a publication, and appropriate credit
shall be given to the U.S. Public Health Service.
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.
_____________________________________
Name (Signature)
Director, Division of AIDS
NIAID, NIH
_______________________ ________________________
Date Title
________________________
Organization
________________________
_________________________
Address
_________________________
Date
[SAMPLE]
*******************************************************************