Partnerships for Biodefense

Partnerships for Biodefense is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). This program provides funding for the development of medical countermeasures against biodefense threats, which includes Ebola. While the specific NOFO for 2026 is not detailed, NIAID consistently funds Ebola research and development through such partnerships.

Expired PAR-03-025: BIODEFENSE PARTNERSHIPS: VACCINES, ADJUVANTS, THERAPEUTICS, DIAGNOSTICS, AND RESOURCES This notice has expired. Check the NIH Guide for active opportunities and notices.

BIODEFENSE PARTNERSHIPS: VACCINES, ADJUVANTS, THERAPEUTICS, DIAGNOSTICS, AND RELEASE DATE: November 14, 2002 (see NOT-AI-03-006 ) PA NUMBER: PAR-03-025 (see Notice of Early Termination NOT-AI-03-035 ) (see replacement RFA-AI-03-016 ) National Institute of Allergy and Infectious Diseases (NIAID) ( http://www. niaid. nih.

gov ) Letter of Intent Receipt Dates: December 23, 2002 and May 10, 2003 Application Receipt Dates: January 24, 2003 and June 10, 2003 o Mechanism(s) of Support o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Receipt and Review Schedule o Required Federal Citations: PURPOSE OF THIS PROGRAM ANNOUNCEMENT (PAR) Research of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives.

The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents.

This includes basic biomedical research, such as studies of microbial physiology and antigenic structure; applied research, including the development of diagnostic tests; and clinical trials to evaluate experimental drugs and In response to growing concerns about the use of biological agents in acts of terrorism, NIAID has identified a list of high priority products to be developed for biodefense that includes specific vaccines, adjuvants and immunostimulants, therapeutics, diagnostics, and clinical resources (see http://www2.

niaid. nih. gov/Biodefense/Research/high_priority.

htm ) and is announcing this Partnership Grant Program to meet these needs. The objective of this grant program is to assist the private sector in the further development of these high priority products.

To be responsive to this program, the applicant must have already identified a candidate product or have demonstrated a proven technical approach or platform in one of the high priority areas and propose a plan for its further development.

Since the clinical development of new products spans a spectrum of activities, the further development of products conducted through this program may fall anywhere along a range of activities from characterization of the product, to preclinical evaluation and/or clinical studies (Phase I and/or Phase II clinical trials).

Applications should define the proposed project goal, interim objectives (development milestones), potential ultimate product(s) to be completed during the period of the grant, and provide a schedule or timeline for milestone and goal attainment.

Note: Applications to support basic research or the "discovery" of new targets will not be supported under this initiative, but are supported by other NIAID biodefense programs (see http://www2. niaid. nih.

gov/Biodefense/Research/funding. htm#B ). A key component of this initiative is the development of appropriate partnerships among government and the biotechnology, chemical, or pharmaceutical industries.

For the purpose of this program, "industry" is defined as large and small, domestic or foreign, pharmaceutical, biotechnology, and chemical companies. Since academic organizations are often the source of new candidate products, this program allows the partnering of industry with an academic or non-profit research organization; however, involvement of an academic or non-profit research organization is not a requirement.

All projects must demonstrate substantive involvement by a commercial sector (industry) component.

"Substantive involvement" is defined, for the purpose of this program, as substantive commitment of any one or more of the following resources: funds, personnel, in kind contributions of materials and/or reagents, including but not limited to chemical libraries, innovative biotechnology platforms, (i.e. for screening of drugs and inhibitors), scale up GMP chemical synthesis or production, provision of animal or other laboratory models for evaluation, data management resources, and regulatory support.

The Principal Investigator may be affiliated with any eligible institutions (see below). The Partnership Program is intended to support all phases of development of a candidate product or platform technology including, but not limited to, early validation, pre-clinical stages, scale-up, production, regulatory requirements, and, where appropriate, clinical or field evaluation.

The NIAID recognizes that the inherent nature and demands of the product development process may require funding large, complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., large-scale production of cGMP product) are inherently not innovative.

Recognizing that product development is often an iterative and sequential process, and that steps early in the process may not be successful and may need to be modified or reworked, NIAID staff, through the cooperative agreement grant mechanism, will be actively involved in evaluating the milestones of awardees and determining whether additional investment in the development is warranted.

The National Institutes of Health and other agencies in the DHHS are currently supporting extramural and intramural projects to develop new products to protect the public from the health consequences resulting from the use of biological threat agents.

An NIAID Blue Ribbon Panel on Biodefense convened on February 4-5, 2002 identified the development of new vaccines, adjuvants, therapeutics, immunotherapeutics and diagnostics as one of the highest priorities (the full report can be found at: http://www2. niaid. nih.

gov/biodefense/research/biotresearchagenda. pdf ). Investment by the private sector in the development of biodefense products is essential but remains limited.

It is imperative that candidate vaccines, therapeutics, adjuvants, diagnostics and resources against selected infectious biological threat agents be developed as quickly as possible to reduce the threat of their use in acts of terrorism or war.

The interaction of industry or non-profit organizations with academic organizations (if applicable) and the Government is strongly encouraged to quickly transition candidate products through preclinical development and clinical testing and commercialization.

This Partnership Program will support the clinical development of specific high priority products beginning with the further characterization of the candidate through preclinical development and Phase I and/or Phase II clinical studies.

Applications in response to this program are limited to selected high priority products (see Research Goals and Potential applicants should also be aware of other biodefense research programs at NIAID that have different research scopes and requirements from those solicited in this PAR, including programs for the discovery of new candidate vaccines, drug targets, and the characterization of innate immune molecules that may be used as adjuvants (see http://www2.

niaid. nih. gov/Biodefense/Research/funding.

htm#B ). Research Objectives and Scope To be responsive to this Program, BIODEFENSE PARTNERSHIPS: VACCINES, ADJUVANTS, THERAPEUTICS, DIAGNOSTICS, AND RESOURCES, the application must: o Address one of the NIAID high priority products for biodefense listed at http://www2. niaid.

nih. gov/Biodefense/Research/high_priority. htm ; o Identify a candidate product or the demonstration of a proven technical approach or platform for further development; and, o Demonstrate substantial involvement by a commercial sector (industry) component and focus on the further development of an ultimate product(s) or strategy for product development in one of the specified high priority areas.

Vaccines are the most effective method of protecting the public against infectious diseases. The development of candidate vaccines against biological threat agents that can be administered quickly and can elicit a protective response in a broad range of recipients is a high priority.

Applications for vaccine development in response to this program are limited to the following areas: vaccines against tularemia; plague vaccines; cell- based smallpox vaccines; Rift Valley Fever vaccines; novel influenza vaccines, including cell culture-based and pandemic influenza vaccine strategies; and vaccines against botulinum toxin.

Research approaches should begin with an identified target or vaccine candidate in one of the above areas and develop a sound scientific rationale for the progression of the candidate vaccine through the product development pathway.

Clinical development activities that can be supported under this program include, but are not limited to, the following areas: o Validation of protective epitopes or antigens; o Optimization of production methodology; o Scale up and production of candidate vaccines including GMP production; o Optimization of delivery platforms; o Evaluation of vaccine candidates formulated with or without adjuvants or o Optimization of dose and route of delivery in pre-clinical evaluation; o Performing preclinical testing for safety and efficacy in animal models and other benchmarks required for moving candidate vaccines into Phase I clinical o Optimization of safety and immunogenicity in Phase I clinical trials; and, o Evaluation of dose-ranging and dosing intervals in Phase II clinical trials, including human challenge studies as appropriate.

Applications should focus on the further clinical development and testing of candidate vaccines identified in one of the above areas deemed responsive to this program. The application should include a sound scientific rationale for the clinical development of the product.

A research and development plan must be included that defines the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provides a schedule or timeline for milestone and goal attainment. The development of enhanced immune responses against biological threat agents may require the administration or co-administration of an adjuvant or immunostimulatory compound.

Applications to support the further clinical development or evaluation of molecules with documented ability to enhance the immune response or immunoregulation are responsive to this program, and products capable of enhancing an innate immune response in the lungs or the gastrointestinal tract are particularly encouraged.

This program supports the further clinical development of vaccine adjuvants and immunomodulators against all NIAID Category A, B, and C priority pathogens that have previously been shown to have promise in early stages of development.

The types of adjuvants or immunomodulators that can be supported under this initiative include, but are not limited to, particulate materials (vaccine delivery systems), cytokines, chemokines, or costimulatory molecule expression, and innate immune receptor/ligand leads (immunostimulatory adjuvants).

Applications that focus on adjuvants known to increase the bioavailability of vaccine antigens (e.g., emulsions, microparticles, iscoms, and liposomes) or that target associated antigens to antigen presenting cells, and immunostimulatory adjuvants (e.g., LPS, MLP, or CpG DNA) that directly activate innate immune responses are also of particular interest.

Applications may propose the further clinical development of an adjuvant or immun0modulator as either a stand-alone product or in conjunction with a licensed or investigational vaccine against a NIAID Category A, B, or C priority pathogen.

Clinical development activities supported under this program may include, but are not limited to, one or more of the following areas: o Analysis of lead compounds based upon previous studies of their antigen targeting capability, receptor binding capacity, or effect on immune o Testing of previously-evaluated adjuvants for their capacity to stimulate enhanced immune responses toward specific NIAID category A, B or C priority o Testing mixtures of adjuvants to evaluate additive or synergistic potential to stimulate desired immune responses; o GMP production of candidate adjuvants or immunomodulators; o Optimization of delivery platform(s), including antigen and adjuvant combinations/formulations; o Optimization of dose, dosing interval, and route of delivery in pre- o Performing preclinical testing for safety and efficacy in animal models and other benchmarks required for moving candidate adjuvants into Phase I o Optimization of safety and immunogenicity in Phase I clinical trials; and, o Evaluation of dose-ranging and dosing interval Phase II clinical trials, including human challenge studies as appropriate.

Applications should focus on the further clinical development and testing of a candidate adjuvant or immunomodulator identified in one of the above areas deemed responsive to this program. The application should include a sound scientific rationale for the clinical development of the product.

A research and development plan must be included that defines the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provides a schedule or timeline for milestone and goal attainment. The need for safe and effective, broad-spectrum and specific, antimicrobials for biodefense against threats by highly pathogenic agents or their toxins is a key national priority.

Applications for development of the following products are responsive under this program: novel antivirals against all NIAID Category A, B, and C priority pathogens, (particularly encouraged are antiviral agents against smallpox and viral hemorrhagic fevers); antitoxins to B. anthracis and C.

botulinum; narrow-spectrum antibiotics against anthrax; passive immunotherapies against any NIAID category A, B, or C priority pathogens; and broad spectrum antimicrobials.

The further characterization of immunotherapeutics such as antimicrobial peptides, lectins, or immune modulators with broadly protective or pathogen-specific potential and novel antibodies shown to have high specificity for antigens from NIAID category A, B, or C priority pathogens is also responsive.

Activities to support the further clinical development of previously identified drug candidates may include but are not limited to, one or more of o Performing molecular modeling and/or library screening to optimize candidate compounds for preclinical studies; o Synthesis of sufficient quantities of a lead compound(s) for in vitro o Performing reiterative design, chemical synthesis and in vitro analysis to develop a "mature" lead compound; o Performing preliminary pharmacokinetics and pharmacodynamics; assessing bioavailability and mechanism of action; o Evaluating the potential for the emergence of drug resistance in model o Synthesizing, purifying, and testing drugs/inhibitors for efficacy and toxicity in model assays and preclinical in vivo systems; o Determining drug interactions in host molecular processes; o Performing required benchmarks for moving a drug candidate into Phase I clinical trials ( http://www.

fda. gov/cder/regulatory/default. htm ); o Optimization of safety in Phase I clinical trials; and, o Evaluation of dose-ranging and dosing interval in Phase II clinical trials, including human challenge studies as appropriate.

Applications should focus on the further clinical development and testing of a candidate therapeutic identified in one of the above areas deemed responsive to this program. The application should include a sound scientific rationale for the development of the product.

A research and development plan must be included that defines the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provides a schedule or timeline for milestone and goal attainment.

There is an urgent need for rapid, highly sensitive, specific, easy to use, and cost-effective diagnostics for public health laboratories and point-of- care use to identify or diagnose individuals exposed to biological threat agents or their toxins.

Diagnostics tools that will rapidly distinguish early infection by a biological threat agent from common infections with similar, generalized symptoms and determine drug sensitivity of the agent are also of This program supports the further development of sensitive, specific, and rapid diagnostics and/or diagnostic methods against all NIAID Category A, B, and C priority pathogens, and of platforms that can distinguish these pathogens from common infections.

It is anticipated that applications will focus on technologies that have previously been shown to have promise in early stages of development.

Applications that focus on the following areas are particularly encouraged: o Tests to evaluate antimicrobial resistance, enhanced virulence, or genetic o Tests capable of high throughput screening (e.g. microchip-based platforms) containing microbial signature profiles; o Tests capable of identifying multiple pathogens simultaneously in a single o Novel assays based on human immune or other physiological responses; o Tests capable of identifying novel biomarkers for human immune activation; o In vivo imaging methods and development of contrast reagents for visualization of pathogens or host immune responses in vivo; o Clinical diagnostic tools for human eczema; and, o Diagnostics that can be used in remote settings.

Applications should focus on the further development and validation of a diagnostic test or diagnostic method. Preliminary data should be presented to support the basis of the method. Capabilities of the diagnostics should be described.

Plans for determining the sensitivity, specificity and validation of the diagnostic should be included in the application. The application should include a sound scientific rationale for the development of the product.

A research and development plan must be included that defines the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provides a schedule or timeline for milestone and goal attainment. The availability of research resources and tools is often a critical component in the development of new vaccines, adjuvants, therapeutics, and diagnostics.

Among the resources needed to conduct biodefense research are genomics, proteomics, appropriate in vitro and animal models, validated assays and standardized reagents.

Applications for research resources in response to this PAR are limited to the following areas: o Vaccine delivery systems and platform technologies; o Software development tools for genetic, genomic, and proteomic analysis and modeling of host-pathogen interactions; o Screening tools and services for high throughput antigen identification; o Appropriate standardized cell cultures and animal models for testing and o Validated assays needed for product licensure including assays to measure toxicity, safety, efficacy, immunogenicity and other host responses.

Applications should focus on the further development and testing of one of the above resources or tools deemed responsive to this program. The application should include a sound scientific rationale for the development of the product.

A research and development plan must be included that defines the proposed project goal, interim objectives (development milestones) and potential ultimate product, and provides a schedule or timeline for milestone and goal attainment. This Partnership Program will use the NIH Cooperative Agreement (U01) grant mechanism.

Under a U01 grant mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award" The total project period for applications submitted in response to this program may not exceed five years.

The estimated total funds [direct and facilities and administrative (F&A) costs] available for the first year of support for all awards made under this program will be $100 million in Fiscal Year 2003. In Fiscal Year 2003, the NIAID plans to fund approximately 20-40 awards. Funds available for additional competing awards in Fiscal Year 2004 have not yet been determined.

To ensure that research aims can be met and biohazards can be contained, an applicant may request up to $500,000 for significant alterations and renovations and/or up to $300,000 for major equipment. Funds for these purposes MUST be included in the first year's requested budget.

Although this program is provided for in the financial plans of the NIAID, awards pursuant to this PAR are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds.

You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, o Units of State and local governments o Eligible agencies of the Federal government Both domestic and foreign organizations are eligible.

Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the All applications must include substantive involvement by industry (as defined above).

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Applications in response to this program are limited to the selected NIAID high priority products described above (under Research Objectives and Scope). Each application must propose a research and development project whose goal is to advance a specific vaccine, adjuvant, therapeutic, diagnostic, or research resource as specified above.

Applications must propose clear project goal(s), including one (or more) final product(s) or stage(s) of development to be completed during the award period.

The applicant must clearly state the interim objectives (developmental milestones) to be achieved during the project, identify impediments or critical decision points that could require a revision in the work plan or milestones, and provide a detailed schedule or timeline for the attainment of each milestone and/or goal.

The successful development of these high priority products for biodefense will require substantial involvement and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions.

It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. Intellectual property rights are likely to play an important role in achieving the goals of this program.

To this end, the NIAID requires that at the time of application all applicants must provide a letter ("Proprietary Rights Assurance Letter") containing the following assurances, which is signed by a representative who is duly authorized to provide such assurances on behalf of the applicant o Applicant is solely responsible for the timely acquisition of all proprietary rights, including intellectual property rights, and all materials needed for applicant to perform the project o Applicant acknowledges that prior to, during, and subsequent to the award, the U.S. Government is not required to obtain for applicant any proprietary rights, including intellectual property rights, or any materials needed by applicant to perform the project o Applicant acknowledges the requirement to report to the U.S. Government all inventions made in the performance of the project, as specified at 35 U.S.C.

Apart from the Proprietary Rights Assurance Letter, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit.

In addition, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, reports to the NIAID or other Applicants must state that the participating institutions are in compliance with Select Agent regulations ( http://www. cdc. gov/od/sap/ ) and NIH Guidelines for Research Involving Recombinant DNA Molecules ( http://www4.

od. nih. gov/oba/rac/guidelines/guidelines.

html ). Phase I and/or Phase II Clinical Trials: Any applicant proposing a project that contains or comprises a Phase I and/or Phase II clinical trial must submit a clinical protocol as part of the application, and a mandatory milestone that must be included is the approval of the final clinical protocol by NIAID. Applicants must build this milestone into their application.

For applications that contain or comprise a Phase I and/or Phase II clinical trial, the NIAID will also require the establishment of an Independent Safety Monitor (ISM), a Safety Monitoring Committee (SMC), or a Data and Safety Monitoring Board (DSMB), as deemed appropriate by NIAID, to monitor the safety of participants in the clinical trial(s).

Applicants proposing a project(s) that contains or comprises a clinical trial(s) should discuss this possibility with NIAID Program Staff before submission of the application.

If a DSMB is required, funds to support and convene the DSMB must be included For guidance on protocol format and/or other issues related to clinical studies and monitoring the safety of human subjects, applicants should contact the DMID Office of Clinical Research Affairs (Contact information is The Principal Investigator, one or two key personnel designated by the Principal Investigator, two external advisors, and the NIAID Program Officer will meet once a year to review progress and aid program development.

Proposed budgets must include funds to travel the Principal Investigator, key personnel, and two external advisors (to be named after award by NIAID in consultation with the Principal Investigator) to an annual two-day meeting in Bethesda, Maryland, or at a relevant scientific meeting, as determined by NIAID Program staff. Names of suggested external advisors should not be included in the application.

A critical determinant of success of the project is likely to be the degree of communication among the grantee organization, any collaborating institutions (if applicable), and the NIH and/or other US government agencies. Regular telephone and written communications on the status of progress among collaborators, including the NIAID Program Officer will be important and are strongly encouraged.

Where scientifically appropriate, NIAID may ask grant recipients to collaborate or cooperate with other NIAID funded projects and/or US government agencies, for example, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the United States Department The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award.

These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is the cooperative agreement (U01), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity.

Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partnership role, but it is not to assume direction, prime responsibility, or a dominant role in the activity.

Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Program 1.

Clinical Terms of Award When human subjects or human samples are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to human subjects. Terms and Conditions of Award will be included with awards. The NIAID policy including terms and conditions of award is available at: http://www.

niaid. nih. gov/ncn/pdf/clinterm.

pdf . 2.

Awardee Rights and Responsibilities Awardees may be from industry or academia; however, the industrial portion of the partnership is critical for compliance and substantive involvement by industry directed to the specific project being proposed must be clearly Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the PAR and for performing the scientific activity.

Specifically, awardees have primary responsibility as described below. The awardee must be in compliance with Select Agent Rule ( http://www. cdc.

gov/od/sap/ ) and NIH Guidelines for Research Involving Recombinant DNA Molecules ( http://www4. od. nih.

gov/oba/rac/guidelines/guidelines. html ). The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIAID staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to the award.

The responsibility for the planning, direction, and execution of the proposed project will be solely that of the Principal Investigator.

For research conducted in foreign countries, the awardee must assure compliance with the host country regulations for human subjects, and must assure that the trials are conducted according to one of the following: the US Federal Policy (Common Rule) for the Protection of Human Subjects and/or the US Department of Health and Human Services (HHS) regulations at 45 CFR 46 http://www. hhs. gov/ohrp/humansubjects/guidance/45cfr46.

htm ; the May 1, 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice (ICH-GCP-E6) Sections 1 through 4; The 1993 Council for International Organizations for Biomedical Research Involving Human Subjects; the 1998 Medical Research Council of Canada Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans; the 2000 Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects; or other internationally recognized standards for the protection of Meetings: One mandatory progress review meeting of the awardees will be held annually at the NIH, or at a site designated by the NIH, during which the Principal Investigator and Project Leaders will present significant findings.

The NIAID Program Officer and External Advisors (when applicable) will be present. A critical determinant of success will be the degree of communication between the Principal Investigator, Project Leaders and other significantly involved parties. Therefore, in addition to the one meeting listed above, additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled if justified.

Regular telephone and written communication will be important and are encouraged. Publications: The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Agreement.

The Principal Investigator and Project Leaders are requested to submit manuscripts to the Program Officer within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained and joint press conferences prepared.

Publications or oral presentation of work done under this Agreement is the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major While the NIAID Program Officer has a right of access to the data (see NIAID staff responsibilities below) the awardee will retain custody of and right to the data.

For more information on data sharing go to: http://grants. nih. gov/grants/policy/data_sharing/index.

htm . 3. NIAID Staff Responsibilities The NIAID Program Officer will provide normal stewardship and will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below.

The NIAID Program Officer will serve as a liaison/facilitator between the awardee, pharmaceutical and biotech industries, and other government agencies (e.g., FDA, USDA, CDC), and will serve as a resource of scientific and policy information related to the goals of the awardee's research.

The NIAID Program Officer will facilitate coordination of project activities during the course The NIAID Program Officer will assist the awardee with access to other NIAID- supported resources and services, including resources for preclinical development such as animal models, screening facilities, standardized research reagents, and a genomics resource center, where available. 3.

Collaborative Responsibilities The specific timelines, interim objectives and funding levels agreed to by the awardee and the NIAID shall be included in the terms and conditions of award. Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. The Principal Investigator and NIAID must agree to all such revisions.

Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective. Where scientifically appropriate, NIAID may ask recipients to collaborate or cooperate with other NIAID funded projects