Autism Data Science Initiative Terms and Conditions

Notice

The following terms and conditions were developed as draft language for the Autism Data Science Initiative (ADSI) and provided to Recipients as part of NIH’s negotiation process. These terms are intended to serve as a baseline framework; however, actual award terms may vary on a case-by-case basis. Because the Other Transaction (OT) authority provides NIH with flexibilities not available under traditional assistance mechanisms, the final negotiated terms for each award may differ based on the specific project, Recipient negotiations, and programmatic considerations. Accordingly, the draft terms and conditions should not be interpreted as the final or uniform requirements for all ADSI awards.

ADSI Awards Draft Terms and Conditions

AGREEMENT #: 1OT2OD0XXXXX-01
(Contact) PI: NAME
 

NATIONAL INSTITUTES OF HEALTH (NIH) 
OFFICE OF THE DIRECTOR (OD)
9000 Rockville Pike 
Bethesda, MD 20892

CONCERNING

(insert project name)

WITH

Autism Data Science Initiative (ADSI)

Other Transaction Agreement No.: 
1OT2OD(insert award number)-01
Authority: 42 U.S.C. 282(n)(1)(B)

This Agreement is entered into between the National Institutes of Health (NIH), an agency of the United States Government, and the (insert organization name) pursuant to and under United States Federal law.

Table of Contents Table of Contents

#Article1Article I. Scope of the Agreement

A.    Background
In accordance with the NIH Research/Engagement Opportunity Announcement OTA-25-006, this award supports the NIH Autism Data Science Initiative (ADSI).

Autism Data Science Initiative (ADSI) brings together diverse data resources and community members with lived experience to explore novel contributors and/or to characterize the collective contributions of numerous factors to the causation of autism spectrum disorder (ASD), hereafter referred to as autism, and their potential role in increasing the prevalence of autism. ADSI also seeks to identify how existing treatments/interventions are used and better understand their outcomes to inform the design of future clinical studies. This initiative will achieve these goals through four strategic aims: 1) to create new integrated data resources, by applying innovative approaches across existing data from research studies or other valid data sources, with rigorous privacy protections, for use by the autism research community; 2) to identify and address gaps in available data through targeted data generation; 3) to support the analysis of these integrated data resources that link data on genetic and nongenetic factors (e.g., diagnostic, clinical, behavioral, neurophysiological, pharmaceutical and environmental exposures, complications of pregnancy and peri-natal events) to explore contributors to the causes of autism and/or to identify patterns associated with treatment/intervention outcomes and the use of services for autism; and 4) to provide a venue for replication of these analyses by independent teams to validate findings and increase transparency in the conduct of science. For the purposes of ADSI, a valid data source is defined as any information that is methodologically sound, ethically obtained, and suitable for drawing meaningful and reproducible conclusions pertaining to the questions at hand.

A key challenge driving ADSI is the need for innovative new approaches that reflect an exposomics framework and that apply new analytic and statistical methods to data derived from human epidemiology and clinical settings. These types of research are needed to advance the study of Gene by Environment (GxE) interactions in autism. Observations of altered prenatal and early-life brain development and dysregulation of neuronal and immune function in people on the autism spectrum and in some non-human model systems can provide clues to identify causative factors. In addition, the male bias and sex-related differences in presentation and underlying biology may also be informative. Large datasets from NIH supported research with clinical data, such as neurophysiological (e.g., electroencephalography, evoked responses, magnetoencephalography, functional magnetic resonance imaging) or other biomarkers, can be leveraged for these purposes. The development of new approach methodologies (NAMs), including complex human-based in vitro models (e.g., brain organoids), has shown promise in addressing some of the knowledge gaps in autism etiology by enabling the experimental study of biologic response to potential neurodevelopmental toxicants or pharmacological treatments and their interaction with genetic susceptibility.  
In addition, studies sponsored by the National Institutes of Health (NIH) and other federal and non-governmental organizations have identified multiple factors that may be driving the increased prevalence of ASD including, but not limited to, changes in diagnostic factors, (e.g., diagnostic ascertainment, diagnostic criteria and/or practices), greater parent and practitioner awareness, and increased development and availability of services and supports that motivate families to pursue a diagnosis. The contribution of other factors that may play a role in the rising prevalence are not well studied or understood and include changes in the patterns and composition of prenatal/early life environmental chemical exposures (e.g., air pollution), parental health factors (e.g., obstetric complications, cardiometabolic diagnoses, maternal stress, and infection and immune alterations), and birth factors (e.g., preterm or very preterm birth). One or more of these factors may be influenced by genetics or interact with genetic susceptibility, reflecting gene-environment interactions (GxE factors). One mechanism by which these nongenetic factors may alter risk is by increasing or decreasing gene expression through epigenetic mechanisms. The totality of nongenetic factors over the life course is represented by the concept of the exposome.  

The (insert organization name) project focuses on the following ADSI Task(s):

Tasks I – III, Data Aggregation and/or Generation, and Analysis: (delete if Tasks IV being funded) 
Data Aggregation activities include formation of a novel dataset/s that could address (1) a variety of known or novel contributors to the risk for autism, or (2) patterns of treatment, intervention, and services and associated outcomes through the use of collaborative research to integrate multiple data sources, including the maximum use of existing large-scale datasets that have been created and maintained by multiple national research institutes, agencies, and organizations from the private and non-profit sectors. Data aggregation of only human datasets (clinical, epidemiological, observational etc.) or both human and non-human (animal models, NAMs, etc.) datasets is allowed and the associated data strategy aligns with the relevant components of the NICHD Record Linkage Implementation Checklist in developing this data strategy. The plan for data acquisition and development and preparation for analysis of secondary dataset/s must ensure that all governance considerations of source data are met, that the Recipients are authorized to access the proposed data sets and/or biospecimens, and that appropriate sharing of any new, derived scientific data generated as a result of the research is maximized. Because much of the data will be controlled access, use of controlled access data must adhere to the updated security standards in the NIH Security Best Practices for Users of Controlled-Access Data.      

Data Generation activities include new data generation that addresses an unmet need for additional data to augment existing data and is complementary to the proposed activities under Task III and under Task I (as applicable), including analysis of existing biospecimens in clinical or human epidemiology studies, use of geospatial models for exposure assignment/estimation, qualitative data collection or surveys in a previously identified population, and use of human-centric new approach methodologies (NAMs). Studies using non-human animal models are not allowed. Data must be collected within the first 18 months or less from the beginning of the funding period along with IRB approval for the research protocol and data sharing plan if proposing new data collection from research participants. Maximum sharing of newly collected dataset/s is expected, in alignment with the NIH Data Management and Sharing Policy. 

Data Analysis activities include rich analysis and rigorous evaluation utilizing advanced data science methodologies, such as artificial intelligence (AI), machine learning (ML), and/or other advanced statistical methods, focusing on the analysis of identified human dataset/s or a combination of human and non-human dataset/s. Analysis restricted to non-human dataset/s is not allowed. Projects must include an explicitly stated hypothesis/es to be tested or if the analyses are hypothesis-generating and pre-register planned variables for analysis/methods for automated/machine learning based models for variable identification.  Maximum sharing of newly developed dataset/s is expected, in alignment with NIH Data Management and Sharing Policy, along with use of established repositories to the extent possible for preserving and sharing scientific data. Additionally, the Recipient is required to share scientific data generated through this award with the NIH-assigned validation recipient for the purpose of 3rd party replication.

OR

Task IV – Model Validation or Model Replication: (delete Tasks I-III above if funded for Task IV) replicate the results of the research studies funded through Tasks I – III through independent validation of models and tools, or the unbiased duplication of studies to reproduce results. Model validation establishes that the model is accurately capturing the mechanism it is intended to measure, and that its performance can be relied on to provide a particular interpretation in the specific context. Method replication studies attempt to duplicate as closely as possible the methods employed in the program’s primary research studies to test the reliability of those results and reproducibility of the findings. Replication studies will not be directed toward the reproduction of results from research outside of the initiative nor for use of non-human animal models for model validation or method replication. These efforts use new data (i.e., data not used in the original study) when feasible to test the same scientific hypotheses as a previous study. Application of methods and tools to similar data from different sources determines the robustness of the results beyond the original context. Scientists conducting replication studies must work with Task I-III scientists doing the primary research to determine from the outset: (a) what data (and metadata) are necessary and available to support replication studies, and (b) what methods and technologies are necessary to replicate the research.

B.   Definitions
In this Agreement, the following definitions apply:

• Agreement: The Terms and Conditions and any Attachments or other documents that are expressly incorporated as part of this Agreement.
• Artificial Intelligence (AI) Model: A component of an information system that implements AI technology and uses computational, statistical, or machine-learning techniques to produce outputs from a given set of inputs.
• Autism or Autism Spectrum Disorder (ASD): a complex neurological and developmental disorder that begins early in life and affects how a person acts and interacts with others, communicates, and learns due to the effects on the structure and function of the brain and nervous system.
• Community-engaged research:  the bidirectional relationship between community partners and the research team in guiding the research project and providing necessary transparency that maximizes the potential to make research more relevant to the partners who will use the research, including those who are at high risk for adverse health outcomes.
• Compute: Compute refers to activities, applications or workloads including storage, networking, and computation (including, but not limited to CPU/GPU/neural processing).
• Data: Recorded information, regardless of form or method of recording, which includes but is not limited to, technical data, mask works, text, sound, images, metadata, video files, drawings, designs, forms, diagrams, data files, statistical records, and other research data. The term does not include financial, administrative, cost, pricing or management information, and does not include subject inventions.
• Deliverables: Any tangible or intangible work product including Data, Inventions, Know-How, and Materials (including third party work product including Data, Inventions, Know-How, and Materials) provided by Recipient to the NIH as a result of the performance of work under the Statement of Objectives and Milestones (SOM).
• Exposomics: The study of the exposome, or the measure of all the exposures of an individual in a lifetime and how those exposures related to health.
• Foreign Firm or Institution: A firm or institution organized or existing under the laws of a country other than the United States, its territories, or possessions. The term includes, for purposes of this Agreement, any agency or instrumentality of a foreign government; and firms, institutions or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals.
• Government: The United States of America, as represented by the Office of the Director (OD) / National Institutes of Health (NIH) (an agency under the U.S. Department of Health and Human Services (DHHS)).
• Indirect (Facilities & Administrative (F & A)) Costs: Those costs incurred for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of indirect (F&A) costs. Indirect (F&A) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.
• Intellectual Property: All copyrights and copyrightable subject matter, including any and all worldwide applications, registrations, renewals, and extensions thereof and all rights of reproduction and publication, rights to create derivative works and all of the rights incident to copyright ownership; all inventions, designs, models, mask works, patents, and pending patent applications; all trademarks, tradenames, service marks, logos, and other commercial symbols, whether registered or unregistered, and pending trademark applications.
• Invention: Any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code.
• Key Personnel: The Program Director/Principal Investigator (PD/PI) and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under this agreement. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as Key Personnel.
• Know-How: All information including, but not limited to discoveries, formulas, materials,  ideas, approaches, concepts, techniques, documentation, procedures, technical data, and specifications,.
• Made: Relates to any invention and means the conception or first actual reduction to practice of such invention.
• Milestones: Milestones are objective measures of progress toward program goals.
• New Approach Methodologies (NAMs): complex human-based in vitro models that includes but is not limited to microphysiologic systems, such as brain organoids.
• Notice of Award (NoA): The system-generated document signed by an Other Transactions Agreements Officer that funds an Other Transaction (OT) award or modification; references Federal funding limits and obligations; incorporates the Agreement and any attachments expressly incorporated; and provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.
  Other Transactions Award: The provision of funds by the National Institutes of Health (NIH), based on an approved application and budget or progress report, to an organizational entity to carry out a project or activity.  OT Awards are subject to the OT authority that governs the initiative, the Agreement, and applicable executive orders, legislative, and regulatory mandates.
• Other Transactions Agreements Officer (OTAO): Individual responsible for legally committing the government to an Other Transaction (OT) award and to the Agreement through which terms and conditions are established, and for the administrative and financial aspects of the award.
• Other Transactions Agreements Specialist (OTAS): A designee of the OTAO for administrative and financial aspects of the award.
• Other Transactions Program Official (OTPO): The NIH official responsible for programmatic oversight and direction of the work performed under the Statement of Milestones (SOM).
• Party: Includes the NIH, or the Recipient, or both.
• Practical Application: To manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is capable of being utilized and that its benefits are, to the extent permitted by law or Federal regulations, available to the public on reasonable terms.
• Principal Investigator/Program Director (PI/PD): Individual designated by the Recipient to have the appropriate level of authority and responsibility to direct the project or program supported by the OT award.
• Project: Research and development being conducted by the Recipient, as set forth in Article I, paragraph E.
• Project Advisor: Government official designated and authorized by the OTPO to provide scientific, technical, and programmatic direction to the Recipient on behalf of the government.
• Recipient: [INSTITUTION], the entity responsible for performing the administrative and programmatic activities described in this Agreement.
• Recipient Business Official (RBO): Individual responsible for the legal commitment by the Recipient and for the administrative and financial reporting compliance with terms and conditions of the Agreement. In signing the OT bilateral Agreement, this individual certifies that the Recipient will comply with all applicable assurances and certifications referenced in the Agreement. This individual’s signature further certifies that the Recipient will be accountable both for the appropriate use of funds awarded and for the performance of the OT-supported project or activities. This individual is responsible for ensuring that the Recipient complies with applicable Federal laws and regulations, including required certifications and assurances, its application and terms and conditions of this OT award. All official correspondence must be submitted by the RBO.
• Sub-recipient: A Non-Federal third party that receives a subaward from a pass-through from an OT Recipient to carry out part of the OT Statement of Milestones (SOM).
• Subject Invention: Any invention conceived or first actually reduced to practice in the performance of work under this Agreement.
• Technology: All Data, Know-How, and Materials developed under this Agreement.
• Third Party: An entity that is involved in some way in an interaction that is primarily between two other entities.
• Unlimited Rights: The royalty free, nonexclusive, and irrevocable rights to use, disclose, reproduce, post, link to, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

C.  Award Notice
This award is supported by the Division of Program Coordination, Planning and Strategic Initiatives/Office of the NIH Director pursuant to OTA-25-006. Future award segment costs and duration are dependent on scientific advancements, programmatic needs, and availability of funds.

D.  Authorization
This award is an “Other Transactions” Award made under the Other Transaction Authority (OTA) as authorized by section 402(n) of the Public Health Service Act as amended [42 USC 282(n)(1)(B)]. This agreement is not governed by the Federal Acquisition Regulation (FAR) or Uniform Administrative Requirements, except for those provisions that are specifically deemed to apply by the terms of this Agreement.

 E.  Goals and Objectives
The purpose of this agreement is to support the Autism Data Science Initiative (ADSI). ADSI will bring together diverse data resources and community members with lived experience to explore novel contributors and/or to characterize the collective contributions of numerous factors to the causation of autism spectrum disorder (ASD), hereafter referred to as autism, and their potential role in increasing the prevalence of autism. ADSI will also seek to identify how existing treatments/interventions are used and better understand their outcomes to inform the design of future clinical studies. This initiative will achieve these goals through four strategic aims: 1) to create new integrated data resources, by applying innovative approaches across existing data from research studies or other valid sources,1 with rigorous privacy protections, for use by the autism research community; 2) to identify and address gaps in available data through targeted data generation; 3) to support the analysis of these integrated data resources that link data on genetic and nongenetic factors (e.g., diagnostic, clinical, behavioral, neurophysiological, pharmaceutical and environmental exposures, complications of pregnancy and peri-natal events) to explore contributors to the causes of autism and/or to identify patterns associated with treatment/intervention outcomes and the use of services for autism; and 4) to provide a venue for replication of these analyses by independent teams to validate findings and increase transparency in the conduct of science.

F.  Scope
The Recipient shall perform a coordinated research and development project designed to develop the ADSI. The research shall be carried out in accordance with the Research Opportunity Announcement (OTA-25-006), which is incorporated in its entirety by reference and the “Statement of Milestones” (SOM) incorporated into this Agreement as Attachments 1.

Subject to the availability of funds, the Recipient shall be paid as described in the Article V: Obligation and Payment and Attachment 2: Statement of Budgetary Projections of this award.

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#Article2Article II. Term

A.    Term of this Agreement
The project commences on X/X/2025 with the issuance of the Notice of Award (NoA) and continues until X/X/202X, or until milestones have been successfully completed as mutually agreed to by the Parties, whichever is sooner, subject to the availability of funds. Provisions of this Agreement, which, by their express terms or by necessary implication, apply for periods of time other than specified herein, shall be given effect, notwithstanding this Article. If all funds are expended prior to the project end date, the Parties have no obligation to continue performance and may elect to end this Agreement at that point.

B.    Termination Provisions
If Recipient has failed to materially comply with the terms and conditions of the award, NIH may take one or more enforcement actions, which include disallowing costs, withholding of further awards, or wholly or partly suspending the OT award, pending corrective action. NIH may also terminate the OT award.

NIH may suspend (rather than immediately terminate) the OT award and allow the Recipient an opportunity to take appropriate corrective action before NIH makes a termination decision; however, NIH may decide to terminate the award if the Recipient does not take appropriate corrective action during the period of suspension. NIH may immediately terminate an OT award when necessary, such as to protect the public health and welfare from the effects of a serious deficiency.

A NIH OT award may also be terminated, partially or totally, by the Recipient. If the Recipient decides to terminate a portion of an OT award, NIH may determine that the remaining portion of the award will not accomplish the purposes for which the award was originally made. In any such case, NIH will advise the Recipient of the possibility of termination of the entire OT award and allow the Recipient to withdraw its termination request. If the Recipient does not withdraw its request for partial termination, NIH may initiate procedures to terminate the entire award for cause. The Recipient may terminate this Agreement by giving the NIH ninety (90) days written notification of its intent to do so, provided that such written notice is preceded by consultation between the Parties.

If the NIH decides to terminate an OT award, the termination of the award will be considered a unilateral change, and the Recipient will not have the right to appeal. Although a decision is made to terminate an award, the Recipient must continue to comply with the Record Retention and Access requirements.

1. The NIH may terminate this Agreement by written notice to the Recipient, provided that such written notice is preceded by consultation between the Parties. The Recipient may terminate this Agreement by giving the NIH Other Transactions Agreements Officer (OTAO) ninety (90) days written notification of its intent to do so, provided that such written notice is preceded by consultation between the Parties.
2. The NIH and the Recipient shall negotiate in good faith a reasonable and timely adjustment of all outstanding issues including amounts due between the Parties as a result of termination, which may include non-cancelable commitments.
3. The Recipient will develop a termination transition plan to be approved by NIH, which includes the following terms:
   1. Information security, including confidentiality, integrity, and availability of Data and systems;
   2. Data transfer process for NIH-owned Data, if applicable;
   3. Relevant records and information to effect termination and Data transfer of NIH owned Data; and
   4. Any other terms deemed necessary by both Parties.
4. In the event that this Agreement is terminated, the NIH shall have paid-up rights in Data owned by NIH as described in Article IX. Software and Data Rights.
5. Failure of the Parties to agree to an equitable adjustment shall be resolved pursuant to Article VI, Disputes. The NIH has no obligation to pay the Recipient beyond the last completed and paid milestone.

C.  Flow Down
Unless modified by the OTAO in writing, the terms of Agreement flow down to Sub-recipients. If the Recipient enters into an agreement with a proposed Sub-recipient(s) that was not included in the application, the NIH requires the Recipient to obtain prior approval from the OTAO before the Recipient enters into an agreement. Recipient is solely responsible for ensuring the OT Sub-recipient(s) is compliant with the flow down terms.

D.  Extending the Term
The Parties may extend by mutual written agreement the term of this Agreement if research opportunities within the scope set forth in Article I reasonably warrant. Any extension shall be formalized through revision of the Agreement by the OTAO, in consultation with the NIH OTPO, and the Recipient Business Official (RBO) and shall be subject to the availability of funds.

E.  Changing the Terms & Conditions
Post-award changes to the terms and conditions are negotiated between the OTAO, in consultation with the NIH OTPO, and the RBO. The OT award mechanism allows significant ongoing involvement from the NIH OTPO and provides the NIH the flexibility to alter the course of the project in real-time to meet the overarching goals. This may mean an awarded activity could be expanded, modified, partnered, not supported, or discontinued based on program needs, emerging methods or approaches, performance, or availability of funds. Performance during the award period will be reviewed on an ongoing basis and course corrections will be made as necessary. For Agreement modifications, refer to Article III. Management of the Project.

F.  eRA Commons Registration for the Principal Investigator (PI)
The individual designated as the PI on the proposal must be registered in eRA Commons. The PI must hold a Project Director (PD) eRA Commons role and be affiliated with the applicant organization. The initial registration must be done by a Recipient Business Official (RBO) who has the Signing Official (SO) role in eRA Commons or other authorized accounts administrators at the organization.

Designating the PI/PD role in the eRA Commons provides the individual with the administrative authority needed to see pertinent information regarding an application (e.g., electronic submission status, review assignment, etc.). The PI/PD role within the eRA Commons is necessary to complete the other transaction application process, and if an award is made, to complete required post-award actions (such as the submission of a progress report).

G.  The System for Award Management (SAM)
Recipients must register in the System for Award Management (SAM) and maintain the registration with current information at all times during which it has an award with NIH. SAM is the primary registrant database for the federal government and is the repository into which an entity must provide information required for the conduct of business.

H.  Research Integrity Procedures and Plans
The Recipient, in compliance with Public Health Service (PHS) Title 42 CFR 93, PHS Policies on Research Misconduct, Subpart C, “Responsibilities of Institutions” must develop and file an Assurance of Compliance with the U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI). The assurance must specify the written policies and procedures for addressing allegations of research misconduct in PHS-supported research. The specific filing requirements can be found at https://ori.hhs.gov/.

I.  The Notice of Award (NoA)
NIH notifies the Recipient via email when an award has been issued. In order to allow for the email notification of the NoA, the Recipient must register a valid email address in the NoA email field in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete. Organizations are encouraged to use a unique email address that is not specific to an individual in order to avoid communication problems when personnel change. It is the responsibility of the Recipient to maintain a current and accurate email address for NoAs. NIH will not distribute NoAs other than through this system-generated email notification process. Recipients that do not maintain a current NoA notification email address will be responsible for accessing NoAs via the eRA Commons.

2 CFR Part 180 and 2 CFR Part 376 (NIH implementation), pursuant to which individuals or entities that have been debarred, suspended, or voluntarily excluded are prohibited from receiving federal funds, are deemed to apply to this Agreement. In addition, 42 CFR Part 93, pursuant to which medical professionals found to have committed research misconduct can be debarred or suspended or subject to PHS administrative actions, including removal from awards or ineligibility for future support, is deemed to apply to this Agreement. Institutions are required to certify that all personnel listed are eligible to receive federal funds; no one is currently debarred, suspended, or proposed for debarment, and Institutions must report any relevant findings of misconduct or actions taken against staff, responsibility checks (including past performance and integrity), disqualification if listed on the SAM exclusion list or under active investigation for serious misconduct.

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#Article3Article III. Management of the Project

The Recipient shall be responsible for the overall management of the project, and technical planning and execution shall remain with the Recipient. The NIH OTPO, in consultation with the NIH OTAO, shall provide recommendations for project developments and technical collaboration and be responsible for the review and verification of the completion of milestone objectives and deliverables.

The OT award mechanism allows the flexibility to alter the course of the project to meet the overarching goals. As a result, the NIH reserves the right to:

• Fund projects in increments and/or with options for continued work at the end of one or more stages through the use of funding restrictions;
• Request additional documentation (certifications, etc.);
• Discontinue negotiations of future award consideration should the parties fail to reach a finalized, fully executed agreement prior to a date determined by the NIH, or the Recipient fails to provide requested additional information in a timely manner; and
• Make post award changes authorized by the OTAO and in coordination with the RBO.

A.  Modifications

1. As a result of interactions with the Recipient or at any time during the term of the Agreement, progress or results may indicate that a change in the Statement of Milestones (SOM) would be beneficial to program objectives. Recommendations to modify the SOM and deliverables may be initiated by either Party. The initiating Party will document in writing and submit to the other Party its recommendations for modifying the SOM, including justifications to support the change. The NIH OTAO, in consultation with the NIH OTPO and the RBO may approve any Agreement modification. Changes to the agreement will into effect with the issuance of the revised NOA.
2. The NIH is not obligated to pay for additional or revised future work to be performed until the SOM is formally revised by the NIH OTAO and made part of this Agreement.
3. The NIH OTPO shall be responsible for the review and verification of any recommendations to revise or otherwise modify the SOM, prospective work, or other proposed changes to the terms and conditions of this Agreement.
4. The NIH OTAO will be responsible for documenting, communicating, and securing any necessary NIH approvals related to modifications to this Agreement.
5. All requests for NIH approval of modifications must be made in writing by the RBO no less than thirty (30) days prior to the proposed date of change. Such requests include any proposed significant changes to this Agreement that would impact the timeline of the project periods, changes in the approved facilities/administrative and/or indirect cost rate, equipment purchases greater than $10,000 per unit not previously included in the approved budget, and other changes affecting the cost, etc. 

B.  Prior Approval

Any prior approval request must be submitted by the RBO to the OTAO (or designated OTAS) and OTPO 30 days prior to the proposed change. Examples of prior approval include but are not limited to:

• Change of PI or other Key Personnel
  The Recipient must submit a prior approval request to the OTAO in writing of a change in Key Personnel or their level of effort only for those key personnel listed in this Agreement. Any change in Key Personnel requires the written approval of the OTAO in consultation with the NIH OTPO, and upon approval a notice or modification to the Agreement will be provided to the Recipient.
  
  Key Personnel:
  XXXXXXX
  
  The Recipient is required to submit a prior approval request to the OTAO if: 
  There is a significant change in the status of the PI or other Key Personnel specifically named in this Article including but not limited to withdrawing from the project entirely, being absent from the project during any continuous period of 3 months or more, or reducing time devoted to the project by 25 percent or more from the level that was approved at the time of initial award (for example, a proposed change from 40 percent effort to 30 percent or less effort or in calendar months a change from 4.8 to 3.6 calendar months). Reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more. Once approval has been given for a significant change in the level of effort, then all subsequent reductions are measured against the approved adjusted level.

  • There is a change from a multiple PI model to a single PI model.  
  • There is a change from a single PI model to a multiple PI model.  
  • There is a change in the number or makeup of the PIs on a multiple PI award.

   

  Alternate arrangements proposed by the Recipient, including any replacement of the PI or key personnel named in this Article, and any change in the number of PIs must be submitted to OTAO for approval. The request for prior approval of any additional or substitute PIs or Key Personnel named in this Article, or change from a multiple PI model to a single PI model, must be submitted promptly, and must be accompanied by a strong scientific justification related to the Hub, including any proposed changes in scope, the biographical sketch of any new individuals proposed and other sources of support, and any budget changes resulting from the proposed change. A new or revised Leadership Plan is required if the request is to change from a single PI model to a multiple PI model, or to change the number or makeup of the PIs on a multiple PI award. The Commons ID must be provided for any new PIs.
  
  In addition, because the Recipient is expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research, the request for approval should indicate whether change(s) in PI or Key Personnel is related to concerns about safety and/or work environments (bullying, retaliation, or hostile working conditions). The Recipient is required to notify NIH when individuals identified as PI or other Key Personnel in an NIH award are removed from their position or are otherwise disciplined by the recipient institution due to concerns about harassment, bullying, retaliation, or hostile working conditions.  Notification must be provided by the Recipient Business Official (RBO) within 30 days of the removal or disciplinary action and must be submitted to NIH through a dedicated web form: Inform NIH About Harassment or Discrimination Concerns. All required notifications must include, at a minimum, the name of the RBO submitting the notification, the name of the individual of concern, a description of the concerns, the action(s) taken, and any anticipated impact on the NIH-funded award(s). If the Recipient has determined that the concerns shared with NIH will impact the PI or key personnel's ability to continue as the scientific lead of the project, NIH will require prior approval for a replacement PI or key person. If the arrangements proposed by the Recipient, including the qualifications of any proposed replacement, are not acceptable to the NIH, the award may be terminated. The requirement to obtain NIH prior approval for a change in key personnel pertains only to those key personnel listed in this agreement regardless of whether the applicant organization designates others as senior/key personnel for its own purposes.

• Budget
  Changes that would require an increase in the obligated budget amount, or significant rebudgeting between approved budget categories in excess of 25% of the categories’ total cost awarded.
• Equipment
  Purchase of the new equipment over $10,000.
• Carryover
  All funds remaining from the prior years are automatically carried forward and available for use for approved budget categories in the subsequent years within the allotted project period. Carryover funds may be used to finish up tasks/milestones from prior years or to offset any future funding within the allotted project period.
• Site Changes
  Changes to funded site(s) and/or sub-recipient(s) engaged in clinical research studies under this Agreement.
  XXXXXX
• No Cost Extension
  Any budget or project period extension beyond the initial budget or project period without additional federal funds requires prior approval. To request the No Cost Extension (NCE) the Recipient must submit a request at least 30 days prior to the budget/project period end dates. The Recipient’s request must include a scientific explanation for any delays in progress; outline of the work that will be completed during the interim NCE period; an estimated time that will be needed to realign the science; an anticipated amount of unobligated balance; and an estimated budget that would be spent during the Interim NCE period. The OTPO may recommend the NCE due, and not limited to, milestone incompletion/delays, low funds burn rate, or program restructuring. The Recipient will be informed by the OTAS or OTAO about the NIH’s intention for NCE at least 30 days prior to the end of the budget period.
  All Federal agencies are required by 31 U.S.C. 1552(a) to close fixed year appropriation accounts and cancel any remaining balances by September 30 of the fifth (5th) fiscal year after the year of availability. In order for the NIH to meet its obligation to close these accounts and cancel any remaining balances by September 30, Recipient must report disbursement on the quarterly cash transaction report using the Federal Financial Report (FFR) no later than June 30 of the fifth (5th) fiscal year after the year of availability. At the end of the five (5) years, the funds are cancelled and returned to the Treasury. This provision may limit NIH’s ability to further extend the final budget period.

C. Monitoring
The Recipient is responsible for managing the day-to-day operations of Agreement activities using their established controls and policies. The NIH OTPO will monitor and identify potential problems and areas where technical assistance might be necessary. This monitoring is accomplished through review of reports provided pursuant to the SOM.

D. Management Systems and Procedures
The Recipient must have in use clearly delineated roles and responsibilities for its organization’s staff, both programmatic and administrative; written policies and procedures; training; management controls and other internal controls; performance assessment; administrative simplifications; and information sharing. The Recipient may use its existing systems to manage Agreement funds and activities, provided that policies and procedures are consistently applied across its business functions. Recipient must notify the Government within 5 business days when problems in financial management are identified.

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#Article4Article IV. Agreement Administration

The NIH will actively engage with Recipient to establish a vision and capabilities for the ADSI and to oversee the effort of individual Recipient to achieve the vision. NIH may change its representatives named in this Article by written notification to the Recipient. Recipient may change its Recipient Business Official named in this Article by written notification to NIH. Recipient may change its Principal Investigator (PI)/Program Director (PD) only with prior approval as described in Article III(B) (Prior Approval). The NIH will effect the change as stated in this Agreement.

Unless otherwise provided in this Agreement, approvals permitted or required to be made by NIH may be made only by the NIH OTAO. Administrative and programmatic matters under this Agreement shall be referred to the following representatives of the Parties:

A.  NIH Points of Contact

Other Transactions Agreements Officer (OTAO)
[Name]
[Title]
[Contact Information]

Other Transactions Agreements Specialist (OTAS)
[Name]
[Title]
[Contact Information]

Other Transactions Program Official (OTPO)
[Name]
[Title]
[Contact Information]
 

B.  Recipient Points of Contact

Recipient Business Official (RBO)
[Name]
[Title]
[Contact Information]

Principal Investigator (PI)/Program Director (PD)
[Name]
[Title]
[Contact Information]

Official information from Sponsored Program
[Address]
[Phone]
[Email]

All official communications must be sent from the Recipient Business Official (RBO), and at a minimum must include the OTAO, OTAS, and OTPO.

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#Article5Article V. Obligation and Payment

A.  Obligation
The NOA provides funds for the budget period as appropriate for the negotiated and agreed upon work. Subsequent funding periods represent projections of future funding levels contingent on the availability of funds, achievement of agreed-upon activities, and continued alignment with programmatic goals. The NIH’s liability to make payments to the Recipient is limited to only those funds obligated under the NOA or by modification to the NOA and is subject to availability of funds. NIH may obligate funds to the NOA incrementally. If modification becomes necessary in performance of this Agreement, the NIH OTAO, in consultation with the OTPO and the RBO shall execute a revised SOM.

B.  Payment
The Payment Management System (PMS) is a centralized payment and cash management system, operated by the Department of Health and Human Services (DHHS) Program Support Center (PSC). Agreement payments by the PMS may be made by one of several advance payment methods, including SMARTLINK II/SCH, cash request, or by cash request on a requirement basis. Payments under this program generally are made on a reimbursement basis. These requirements are intended to minimize the time elapsing between the transfer of funds from the Federal Government and disbursement to the Recipient.
Advances made by Recipient to third parties under the Agreement must conform to substantially the same standards of timing and amount that govern advances to the Recipient.
Operational guidance for the Recipient is provided through training from the DHHS PSC. Inquiries regarding drawdown request, cash management rules, and the disbursement of funds through the Federal Financial Report (FFR) SF 425 should be directed to the DHHS PSC (https://pms.psc.gov/grant-recipients/ffr-updates.html).

C.  Earned Interest on Advances
Recipients receiving advance payments must maintain those advanced funds in an interest-bearing account and promptly return any funds not spent within three (3) business days. Interest earned on federal advance payments deposited in interest-bearing accounts must be remitted annually to the Department of Health and Human Services, Payment Management System, 11400 Rockville Pike Rockwall I, Suite 700, Rockville, MD 20852. Interest amounts up to $500 per year may be retained by the Recipient for administrative expenses.

D.  Limitation of Funds
In no case shall the NIH’s financial liability exceed the amount obligated under the NoA.

E.  Appropriation Mandates
This award must comply with NIH fiscal appropriation mandates. Refer to https://grants.nih.gov/grants/policy/appropriations_info.htm for additional guidance.

F.  Close out of Fixed Year Appropriations Amounts
All Federal agencies are required by 31 U.S.C. 1552(a) to close fixed year appropriation accounts and cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability. In order for the NIH to meet its obligation to close these accounts and cancel any remaining balances by September 30, Recipients must report total disbursements no later than June 30 of the fifth fiscal year after the year of availability. At the end of five years, the funds are canceled and returned to the Treasury.

Fixed year appropriation accounts have a five (5)-year availability span. Recipient must draw down all appropriated fiscal year award funds no later than June 30th of the fifth year after the year of availability. At the end of five years, the funds are cancelled and returned to the Treasury. This provision may limit the NIH’s ability to further extend the final budget period.

G.  Financial Records and Reports
The Recipient shall maintain adequate records to account for all funding under this Agreement. Upon completion or termination of this Agreement, whichever occurs earlier, the Recipient shall furnish to the OTAO a copy of any final reports specified in the SOM. The OTAO or designee shall have direct access to sufficient records and information of the Recipient, to ensure full accountability for all funding under this Agreement. Such audit, examination, or access shall be performed during business hours on business days upon prior written notice and shall be subject to the security requirements of the audited party.

The Recipient’s relevant financial records are subject to examination or audit on behalf of the NIH or by the NIH for a period not to exceed three (3) years. For OT awards, the 3-year record retention period will be calculated from the date that the Federal Financial Report (FFR) for the entire competitive segment is submitted. If any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken. These record retention policies apply to both paper and electronic storage of applicable information, including electronic storage of faxes, copies of paper documents, images, and other electronic media.

H.  Comptroller General Access
To the extent that the total Government payment under this Agreement exceeds $5,000,000, the Comptroller General, at its discretion, shall have access to and the right to examine records of any entity that participates in the performance of this Agreement for a period of three (3) years after final payment is made. This requirement shall not apply with respect to any entity that has already entered into any other agreement (contract, grant, cooperative agreement, or “other transaction”) that grants audit access by a Government entity in the year prior to the date of this Agreement. This paragraph only applies to any record that is created or maintained in the ordinary course of business or pursuant to a provision of law. The terms of this paragraph shall be included in all Sub- Agreements of this Agreement.

I.  Undisbursed Obligated Balances and Actual Expenditures
Using the principle of “first-in, first-out” undisbursed obligated funds carried over into a new budget period must be used before newly awarded funds.

J.  Audit
For purposes of this Agreement, the Recipient is deemed subject to the audit requirements of OMB 2 CFR 200, Subpart F-Audit Requirements, as implemented by DHHS 45 CFR Subpart F.

For-profit organizations have two options regarding the type of audit that will satisfy the audit requirements. The recipient either may have (1) a financial-related audit (as defined in, and in accordance with, the Government Auditing Standards (commonly known as the “Yellow Book”), GPO stock 020-000-00-265-4, of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one DHHS program, or (2) an audit that meets the requirements of 45 CFR 75, Subpart F-Audit Requirements.

K.  Financial Management System Standards
The Recipient must have and maintain an established accounting system which complies with Generally Accepted Accounting Principles (GAAP) and accounting and internal control systems must provide for appropriate monitoring of award accounts to ensure that obligations and expenditures are reasonable, allocable, and allowable. In addition, the systems must be able to identify unobligated balances, accelerated expenditures, inappropriate cost transfers, and other inappropriate obligations and expenditures of funds, and Recipient must notify the NIH OTAO when problems are identified. The Recipient’s failure to establish adequate control systems constitutes a material breach of this Agreement and may result in the exercise of available enforcement remedies.

L.  Procurement System Standards and Requirements
Recipients may acquire a variety of goods or services in connection with an OT award-supported project, ranging from those that are routinely purchased goods or services to those that involve substantive programmatic work. Recipients must acquire goods and services under OT awards in compliance with their established policies and procedures and for the negotiated purposes outlined in the SOM.

M.  Cost Principles
This Agreement is subject to reimbursement of actual, allowable costs incurred and must align with generally accepted and established federal cost principles for the entity receiving funding (academic, non-profit, for-profit, etc.). Recipient must exercise proper stewardship over Federal funds and ensure that costs charged to awards are allowable, allocable, reasonable, necessary, and consistently applied.

N.  Payments for Human Subjects Research
This award is issued with the knowledge that human subjects will be involved within the period of support. No human subjects may be involved in any project supported by this award until all requirements for Human Subjects research, OHRP assurance and IRB-approval have been provided to and approved by NIH staff.

O.  Animal Research
The Recipient shall not draw down funds from the payment system and no obligations may be made against Federal funds for research involving animals for the ADSI funded project. Failure to comply will result in the immediate suspension and/or termination of this Agreement.

P.  Salary Rate Limitation
None of the funds in this award shall be used to pay the salary of an individual at a rate more than the current salary cap. See current salary cap levels at the following URL: http://grants.nih.gov/grants/policy/salcap_summary.htm.

1. NIH appropriation mandates that no funds appropriated shall be used to pay a salary (including executive salaries) that exceeds the Executive Level II of the Federal Executive pay scale. Effective October 1, 2024, this limitation applies to direct salaries as well as indirect salaries that are part of the indirect pool used to calculate indirect rates.
2. Recipients may not draw down funds, whether direct or indirect costs, to pay salaries above the salary rate limitation, and recipients must have established policies and procedures that are consistently applied regardless of the source of funds.
3. NIH OT awardees that do not have an approved indirect cost rate that complies with the NIH Salary Rate Limitation requirement must take and document the following actions:
   1. Identify any NIH award where NIH funds are used to pay any salary that exceeds the Salary Rate Limitation using the NIH award. This includes both direct and indirect costs, both in whole and any portion of a salary that at a full-time equivalent exceeds the Salary Rate Limitation.
   2. Have written policies and procedures that ensure the recipient does not draw down NIH award funds, whether as direct or indirect costs, to pay for salaries above the NIH Salary Rate Limitation.
   3. Recipients may pay salaries at a rate higher than the Executive Level II if the amount beyond the SRL is paid with non-federal funds.
       

Q.  Other Support
Pursuant to this Agreement, Recipient shall submit information in accordance with NIH policy on “other support,” which includes all resources made available to all individuals who will make a scientific contribution to the project. These reportable resources include support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the organization the researcher identifies for the current Agreement. This includes resource and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, positions and scientific appointments both domestic and foreign held by senior/Key Personnel that are relevant to an application including affiliations with foreign entities or governments, domestic research collaborations that directly benefit the researcher’s research endeavors, and provision of high-value materials that are not freely available. NIH policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html. Other Support instructions can be found here: https://grants.nih.gov/grants-process/write-application/forms-directory/other-support-format-page.

Commitment overlap occurs when any project-supported personnel (including support staff and key personnel) have time commitments exceeding 100 percent, regardless of how the effort/salary is being supported or funded. Therefore, no individual may reflect over 100 percent in the total effort he/she spends on research and other organizational responsibilities. An investigator may be affiliated with several organizations; however, the combination of appointments cannot exceed 100 percent. Reporting zero percent of effort is not acceptable. The award organization is responsible for ensuring no individual supported by this award exceeds 100 percent committed effort.

R. Recovery of Funds
NIH may identify and administratively recover funds paid to a Recipient at any time during the life cycle of an OT award. Debts may result from cost disallowances, unobligated balances, unpaid share of any required matching or cost-sharing, funds in the account that exceed the final amount determined to be allowable, or other circumstances. NIH is required to collect debts due to the Federal Government and, except where prohibited by law, to charge interest on all delinquent debts owed to the Government by the Recipient.

S. Debt Collection
The debt collection process is governed by the Federal Claims Collection Act, as amended (Public Law [P.L.] 89-508, 80 Stat. 308, July 19, 1966); the Federal Debt Collection Act of 1982 (P.L. 97-365, 96 Stat. 1749, October 25, 1982); the Debt Collection Improvement Act (P. L. 104-134, 110 Stat. 1321, April 26, 1996); and the Federal Claims Collection Standards (31 CFR Parts 900-904), which are implemented for DHHS in 45 CFR 30. NIH is required to collect debts due to the Federal Government and, except where prohibited by law, to charge interest on all delinquent debts owed to NIH by Recipients.

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#Article6Article VI. Disputes

General

The Parties shall communicate with one another in good faith and in a timely and cooperative manner when raising issues under this Article. 

A. Dispute Resolution Procedures

Any disagreement, claim or dispute between NIH and the Recipient concerning questions of fact or law arising from or in connection with this Agreement, and whether or not, involving an alleged breach of this Agreement, may be raised only under this Article. Whenever disputes, disagreements, or misunderstandings arise, the Partiers shall attempt to resolve the issue(s) involved by discussion and mutual agreement as soon as practicable.

Recipient is responsible for managing its relationship and agreements with sub-recipients and other partners. NIH will not intervene or otherwise be involved in any disagreement, claim, dispute, misunderstanding or other conflict the Recipient has with their sub-recipients or other partners. Resolution of any disagreement, claim, dispute, misunderstanding or other conflict the Recipient has with their sub-recipients or other partners must be resolved by following the Recipient’s grievance, mediation or conflict resolution policies and procedures. 

B. Limitation of Damages

Claims for damages of any nature whatsoever pursued under this Agreement shall be limited to direct damages only up to the aggregate amount of NIH funding disbursed as of the time the dispute arises. SUBJECT TO APPLICABLE LAW IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR CLAIMS FOR CONSEQUENTIAL, PUNITIVE, SPECIAL, OR INCIDENTAL DAMAGES, CLAIMS- FOR LOST PROFITS, OR OTHER INDIRECT DAMAGES, IN NO EVENT SHALL A PARTY BE LIABLE FOR THE OTHER PARTY’S OWN GROSS NEGLIGENCE, FRAUD, OR WILLFULL MISCONDUCT. The amount of any loss for which NIH is responsible shall be reduced by any amounts actually and irrevocably recovered by the Recipient including insurance proceeds. 

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#Article7Article VII. Intellectual Property Rights

General

Each Party owns and retains all right, title and interest in and to its intellectual property rights, including all derivative and enhancements thereof, and this Agreement does not grant, by implication, estoppel or otherwise, either Party any right, title, interest, or license in or to the other Party’s intellectual property rights except as expressly provided herein. 

A. Joint Development

The Parties do not intend to jointly conceive or reduce to practice any technology or Intellectual Property rights under this Agreement (“Joint IP”). Notwithstanding the above, in the event Joint IP is created by operation of law, the Parties will own the IP in accordance with the provisions of U.S. patent and copyright law unless alternative terms are mutually agreed to in a separate agreement pertaining thereto. Notwithstanding the foregoing, any work of authorship created by the NIH is a work of the United States Government and copyright may not be established in the United States pursuant to 17 U.S.C. § 105. 

B. Freedom of Action

This Agreement is non-exclusive, and the relationship established by its terms is intended to be non-exclusive. Subject to its obligations of confidentiality and to each Party’s Intellectual Property Rights, as described in the Agreement, in no event shall either party be:

• precluded from developing or providing for itself, or for others, materials that are competitive with the products and services of the other Party, irrespective of their similarity to any products or services offered by the other Party in connection with this Agreement; or
• precluded from entering into similar agreements with others or from developing, selling, or licensing products and services competitive with the products and services of the other Party, except as may be otherwise set forth in a separate agreement between the Parties. 

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#Article8Article VIII. Patent Rights

A. Allocation of Principal Rights

Unless the recipient shall have notified the NIH that the Recipient does not intend to retain title, the Recipient shall retain the entire right, title, and interest throughout the world to each Subject Invention consistent with the provisions of this Article.

With respect to any Subject Invention in which the Recipient retains title, the Government shall have a nonexclusive, nontransferable, irrevocable, royalty-free, paid-up license to practice or have practiced for or on behalf of the United States the Subject Invention throughout the world. 

B. Invention Disclosure, Election of Title, and Filing of Patent Application

The Recipient shall disclose each Subject Invention to NIH within four (4) months after the inventor discloses it in writing to the Recipient personnel responsible for patent matters. The disclosure to NIH shall be in the form of a written report and shall identify the Agreement and circumstances under which the Invention was made and the identity of the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding, to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the Invention. The disclosure shall also identify any publication, sale, or public use of the invention and whether a manuscript describing the Invention has been submitted and/or accepted for publication at the time of disclosure.  

The Recipient will elect whether or not to retain title to any such Invention by notifying the NIH, in writing within two years of disclosure to NIH. However, in any case where publication, sale, or public use has initiated the one-year statutory period wherein valid patent protection can still be obtained in the United States, the period for such notice may be shortened by NIH to a date that is no more than ninety (90) calendar days prior to the end of the statutory period.

The Recipient shall file its initial application on a Subject Invention to which it elects to retain title within one (1) year after election of title or, if earlier, prior to the end of the statutory period wherein valid patent protection can be obtained in the United States after a publication, or sale, or public use.

The Recipient may elect to file patent applications in additional countries, including the European Patent Office and the Patent Cooperation Treaty, within either ten (10) months of the corresponding initial patent application or six (6) months from the date permission is granted by the Commissioner for Patents to file foreign patent applications, where such filing has been prohibited by a Secrecy Order.

The Recipient shall notify NIH of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceedings on a patent, in any country, not less than sixty (60) calendar days before the expiration of the response period required by the relevance patent office.

Requests for extension of the time for disclosure election, and filing under Article VIII, may be granted at NIH’s discretion after considering the circumstances of the Recipient and the overall effect of the extension.  

The Recipient shall submit to NIH annual listings of Subject Inventions (Negative annual reports are not required). At the completion of the Agreement, the Recipient shall submit a comprehensive listing of all Subject Inventions identified during the course of the Agreement and the current status of each. A negative report is required at the completion of the Agreement, if there are no Subject Inventions. If there were no inventions, the form must indicate "None."

C. Conditions When the NIH May Obtain Title

Upon NIH’s written request, the Recipient shall convey title to any Subject Invention to NIH under any of the following conditions:

If the Recipient fails to disclose or elects not to retain title to the Subject Invention within the times specified in this Article;

in those countries in which the Recipient fails to file patent applications within the times specified in this Article; however, if the Recipient has filed a patent application in a country after the times specified in this Article, but prior to its receipt of the written request by NIH, the Recipient shall continue to retain title in that country; or

In any country in which the Recipient decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceedings on, a patent on a Subject Invention. 

D. Minimum Rights to the Recipient and Protection of the Recipient’s Right to File

The Recipient shall retain a nonexclusive, royalty-free, commercial license throughout the world in each Subject invention to which the NIH obtains title, except if the Recipient fails to disclose the Subject Invention within the times specified in this Article. The Recipient’s license extends to its domestic subsidiaries and affiliates, if any, and includes the right to grant licenses of the same scope to the extent that the Recipient was legally obligated to do so at the time the Agreement was awarded. Any extension of the Recipient’s license to its subsidiaries and affiliates that are based outside the United States must comply with all export control laws and other federal laws that may apply. The license is transferrable only with the approval of NIH, except when transferred to the successor of that part of the business to which the Subject Invention pertains. NIH approval for license transfer shall not be unreasonably withheld.

The Recipient’s domestic license may be revoked or modified by NIH to the extent necessary to achieve expeditious practical application of the Subject Invention pursuant to an application for an exclusive license submitted consistent with appropriate provisions at 37 C.F.R. Part 404.

This license shall not be revoked in that field of use or the geographical areas in which the Recipient has achieved practical application and continues to make the benefits of the Subject Invention reasonably accessible to the public. The license in any foreign country may be revoked or modified at the discretion of NIH to the extent the Recipient, its licensees, or the subsidiaries or affiliates have failed to achieve practical application in that foreign country.

Before revocation or modification of the license, NIH shall furnish the Recipient a written notice of its intention to revoke or modify the license, and the Recipient shall be allowed thirty (30) calendar days (or such other time as may be authorized for good cause shown) after the notice to show cause why the license should not be revoked or modified. 

E. Recipient Action to Protect the NIH’s Interest

The Recipient agrees to execute or to have executed and promptly deliver to NIH all instruments necessary to (i) establish or confirm the rights the NIH has throughout the world in those Subject Inventions to which the Recipient elects to retain title, and (ii) convey title to NIH when requested under this Article and to enable the NIH to obtain patent protection throughout the world in that Subject Invention.

The Recipient agrees to require by written agreement with its employees, other than clerical and non- technical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the Recipient each Subject Invention made under this Agreement in order that the Recipient can comply with the disclosure provisions of this Article. The Recipient shall instruct employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to United States or foreign statutory bars.

The Recipient shall include, within the specification of any United States patent application and any patent issuing thereon covering a subject invention, the following statement: “This invention was made with government support under Agreement No: 1OT2OD0XXXXX-01 awarded by the National Institutes of Health. The government has certain rights in the invention.” 

F. Reporting on Utilization of Subject Inventions 

The Recipient agrees to submit, during and after the term of the Agreement, an annual report on the utilization of a Subject Invention or on efforts at obtaining such utilization that are being made by the Recipient or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, and gross royalties received by the Recipient. The Recipient also agrees to provide additional reports as may be requested by NIH in connection with any march-in proceedings undertaken by NIH in accordance with this Article. NIH agrees it shall not disclose such information to persons outside the NIH without permission of the Recipient, unless required by law.

All required reporting shall be accomplished, to the extent possible, using the i-Edison reporting website: https://www.nist.gov/iedison. To the extent any such reporting cannot be carried out by use of i-Edison, reports and communications shall be submitted to the OTAO and OTPO by Additions Tabs in eRA system.

G. Preference for United States Industry

Notwithstanding any other provision of this clause, the Recipient agrees that it shall not grant to any person the exclusive right to use or sell any Subject Invention in the United States unless such person agrees that any product embodying the Subject Invention or produced through the use of the subject invention shall be manufactured substantially in the United States. However, in individual cases, the requirements for such an agreement may be waived by NIH upon a showing by the Recipient that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that, under the circumstances, domestic manufacture is not commercially feasible. 

H. March-in Rights

The Recipient agrees that, with respect to any Subject Invention in which it has retained title, NIH has the right, in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations to require the Recipient, an assignee, or exclusive licensee of a Subject Invention to grant a non-exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the Recipient, assignee, or exclusive licensee refuses such a request, NIH has the right to grant such a license itself if NIH determines that: 

• Such action is necessary because the Recipient or assignee has not taken effective steps, consistent with the intent of this Agreement, to achieve practical application of the Subject Invention;
• Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the Recipient, assignee, or their licensees;
• Such action is necessary to meet requirements for public use and such requirements are not reasonably satisfied by the Recipient, assignee, or licensees; or
• Such action is necessary because the agreement required by this Article has not been obtained or waived or because a licensee of the exclusive right to use or sell any Subject Invention in the United States is in breach of such Agreement. 

I. Background Inventions  

Background Invention means any Invention in which the Recipient or sub-Recipients of any tier has retained title that (1) was not conceived or first actually reduced to practice in the performance of work under this Agreement and (2) was developed at private expense, either exclusively or partially. The Parties agree to the following: 

1. With respect to any Background Invention incorporated into Deliverables or otherwise made available to the Government under this Agreement, the Government shall have a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for any Government purpose, and to authorize others to do so.
2. Incorporated into this Agreement as Attachment 5, the Recipient has disclosed in good faith a table of asserted Background Inventions that identifies for each Background Invention a minimum of the following:
   1. The US Patent or patent application covering the Background Invention; and
   2. The work products to be delivered under this Agreement that incorporate the Background Invention.
3. Any Invention arising under this Agreement or incorporated into work products delivered or otherwise made available to the Government under this Agreement shall be considered a Subject Invention if such Invention has not been asserted by the Recipient to be a Background Invention in Attachment 5.
4. In addition to the assertions made at the time of the execution of this Agreement, other asserted Background Inventions may be identified and added to Attachment 5 after award via mutual agreement of the Parties when based on new information or inadvertent omissions, unless the inadvertent omissions would have materially affected the NIH’s decision to execute this Agreement.  

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#Article9Article IX. Software and Data Rights

The NIH will encourage creating and using available open-source technology and architecture when available and to the extent practicable and justify when this is not practicable. Intellectual property rights asserted by proposers must be aligned with the open-source regime used to distribute software made under the award. Exceptions to open-source technology will be considered only in compelling cases and must be granted in writing. For the avoidance of doubt, software includes all data, algorithms (including AI models), and source code necessary to utilize the software. 

A. Principal Rights

The Parties agree that in consideration for NIH funding, the Recipient intends to reduce to practical application terms, components and processes developed under this Agreement.

The Recipient warrants that Recipient or Sub-recipient are sole author or owner of, or have the right to use and license, any Data, Software, and Data that comprises the Software developed under this Agreement and that any Data or Software provided or developed under this Agreement does not infringe any rights, including Intellectual Property rights of any third party of which the Recipient is aware. With respect to any Data or Software provided or developed under this Agreement, the Recipient will own the Data and Software provided or developed under this award, subject to a royalty-free, nonexclusive, irrevocable license to the Government to use, disclose, reproduce, post, link to, prepare Data and Software, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so on the Government’s behalf anywhere in the world. 

B. Derivative Works

The Recipient grants to the Government a royalty-free, nonexclusive, irrevocable right to use, disclose, reproduce, post, link to, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so on the Government’s behalf anywhere in the world, any derivative works of the Data or Software provided or developed by Recipient under this Agreement. 

C. March-In Rights

In the event the NIH chooses to exercise its March-in Rights with respect to any Subject Inventions (as set forth in Article VIII), the Recipient agrees, upon written request from the NIH, to deliver at no additional cost to the NIH, all Data necessary to achieve practical application within sixty (60) calendar days from the date of the written request. The NIH shall retain Unlimited Rights to this delivered Data. To facilitate any potential deliveries, the Recipient agrees to retain and maintain in good condition until three years after completion or termination of this Agreement, all Data necessary to achieve practical application of any Subject Invention. 

D. Marking of Data

Any Data delivered under this Agreement shall be marked with the following legend: 

The Government may use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly this Data, in any manner and for any purpose allowable under the law, regulations, and NIH policy, and to have or permit others to do so. 

This Agreement aligns with the NIH Data Management and Sharing Policy regarding government use of data generated and delivered under this Agreement, and data must be marked accordingly. 

E. Background Data

Background Data means any Data in which the Recipient holds rights of ownership as recognized by U.S. law which (1) was not generated under this Agreement and (2) was developed at private expense, either exclusively or partially. The NIH recognizes that Background Data may be vital to the Recipient’s commercial success and business interests. At the same time, the NIH may need to obtain certain limited rights in Background Data in order to make effective use of work products delivered or otherwise made available to the Government under this Agreement. In order to balance these interests and distinguish between Background Data and Data generated or developed under this Agreement, the Parties agree to the following:  

1. With respect to any Background Data incorporated into work products delivered under this Agreement, the NIH shall have a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for any Government purpose allowable under the law, regulations, and NIH policy, and to authorize others to do so. Notwithstanding the above, NIH shall not reverse engineer, disassemble, or decompile the Background Data in an attempt to permit re-identification of any individual in any manner, and shall require the same of any other user of the work products.    
2. Incorporated into this Agreement as Attachment X, the Recipient has identified and asserted in good faith a table of all Background Data to be furnished to the Government with restrictions on use, release, or disclosure. This table of asserted Background Data should include the following information for each item of Background Data:
   1. Background Data to be Furnished with Restrictions. The Recipient should identify the Background Data or enter “none” when all Background Data will be submitted without restrictions;
   2. Basis for Assertion. Generally, development at private expense, either exclusively or partially, is the only basis for asserting restrictions. For technical data, other than computer software documentation, development refers to development of the item, component, or process to which the data pertain. The Government's rights in computer software documentation generally may not be restricted. For computer software, development refers to the software. Indicate whether development was accomplished exclusively or partially at private expense. If development was not accomplished at private expense, or for computer software documentation, the Recipient should enter the specific basis for asserting restrictions;
   3. Asserted Rights Category. Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR data generated under another contract, limited, restricted, or government purpose rights under this or a prior contract, or specially negotiated licenses);
   4. Name of Person/Entity Asserting Restrictions. The Recipient should identify the corporation, individual, or other person, as appropriate.
3. The Government shall have Unlimited Rights in any Data, Technology, or Know-How arising under this Agreement or incorporated into work products delivered or otherwise made available to the Government under this Agreement unless the Recipient has identified and asserted the Data, Technology, or Know-How as Background Data in Attachment 5.  
4. In addition to the assertions made at the time of the execution of this Agreement, other asserted Background Data may be identified and added to Attachment 5 after award via mutual agreement of the Parties when based on new information or inadvertent omissions, unless the inadvertent omissions would have materially affected the NIH’s decision to execute this Agreement. 

F. Open Source

Upon publication resulting from this Award or prior to the termination of the award, whichever comes first, the Recipient shall make all Data, Software, models, tools, resources, training materials, technical solutions, and methods provided or developed under this Agreement available to the public under a Creative Commons By (CCBY) or comparable license, or at minimum controlled- access repository, to the extent possible. It is the Recipient’s responsibility to ensure that any PII or protected health information (PHI)(as defined by 45 C.F.R. § 160.103) in any Data, Software, models, tools, resources, training materials, technical solutions, or methods provided or developed under this Agreement be deidentified prior to availability to the public. A suitable repository or repositories selected in concurrence with NIH may be used to facilitate making Data, Software, models, tools, resources, training materials, technical solutions, and methods available to the public. Repositories selected should have a sustainability plan reviewed by NIH.

For AI models trained with PII, /PHI, or other identifiable Background Data protected under federal law (“Identifiable Data”), the NIH encourages the development of code repositories and accompanying publications to permit the sharing of models without any Identifiable Data. If any Identifiable Data from a model cannot be removed, de-identified, or otherwise concealed, Award Recipients should provide details to NIH regarding the owner(s) of all Identifiable Data. In such circumstances, NIH shall enter into any required Data Use Agreements pertaining to the Identifiable Data and shall require the same of any other entities that access such models. 

G. Rights in Data (Publication and Copyrighting)

Any publications, data, or other copyrightable works developed under a ADSI OT award may be copyrighted without NIH approval. Rights in data also extend to students, fellows, or trainees under awards whose primary purpose is educational, with the authors free to copyright works without NIH approval. 

In all cases, NIH must be given a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for Federal purposes. Data developed by a Recipient participant also is subject to this policy. As a means of sharing knowledge, NIH encourages recipient to arrange for publication of NIH-supported original research in primary scientific journals. Recipient also should assert copyright in scientific and technical articles based on data produced under the OT award where necessary to effect journal publication or inclusion in proceedings associated with professional activities. Journal or other copyright practices are acceptable unless the copyright policy prevents the recipient from making copies for its own use or from complying with the NIH Public Access Policy (https://publicaccess.nih.gov/). Recipient must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal money. Each publication, press release, or other document about research supported by an NIH OT award must include: 

• An acknowledgment of NIH OT award support such as: “This research was, in part, funded by the National Institutes of Health (NIH) under other transactions 1OT2OD0XXXXX-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing official policies, either expressed or implied, of the NIH.”
• If the Recipient plans to issue a press release about research supported by an ADSI OT award, it should notify the NIH OTAO, OTPO and OTAS at least thirty (30) days in advance to allow for coordination. Publications resulting from work performed under a ADSI OT award-supported project must be included as part of the interim, annual, or final progress report submitted to the NIH OTAO, OTPO and OTAS.  

H. NIH Public Access Policy

Recipient must comply with the 2024 NIH Public Access Policy.  The 2024 NIH Public Access Policy implements Division F, Section 217 of PL 111-8 (Omnibus Appropriations Act, 2009). The policy ensures that the public has access to the published results of NIH-funded research at the NIH National Library of Medicine (NLM) PubMed Central (PMC), a free digital archive of full-text biomedical and life sciences journal literature (https://pmc.ncbi.nlm.nih.gov/). Under the policy NIH-funded investigators must submit (or have submitted for them) to PMC (https://pubmed.ncbi.nlm.nih.gov/) an electronic version of the final, peer-reviewed manuscript upon acceptance for publication, to be made publicly available no later than the official date of publication. The author's final peer-reviewed manuscript is defined as the final version accepted for journal publication and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this policy.

I. Sharing Research Resources

NIH considers the sharing of research resources (also called research tools) an important means to enhance the value of NIH-sponsored research. Restricting the availability of unique resources can impede the advancement of further research. Therefore, when these resources are developed with NIH funds and the associated research findings have been accepted for publication, or after they have been provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community and the public. Program staff are responsible for overseeing resource sharing policies and for assessing the appropriateness and adequacy of any proposed resource sharing plans. To provide further clarification of the NIH policy on disseminating unique research resources, NIH published Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; https://grants.nih.gov/grants/policy/nihgps/html5/section_8/8.2.3_sharing_research_resources.htm) and Best Practices for the Licensing of Genomic Inventions (70 FR 18413, April 11, 2005; https://www.govinfo.gov/content/pkg/FR-2005-04-11/pdf/05-7247.pdf). These policy documents will assist recipient in determining reasonable terms and conditions for disseminating and acquiring research tools.

The Recipient agrees to comply with the NIH resource sharing policies (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.3_sharing_research_resources.htm). Recipient is required to submit a Resource Sharing Plan that addresses Sharing Model Organisms and Research Tools, as applicable. For more information, see the NIH Model Organism Sharing Policy (https://sharing.nih.gov/other-sharing-policies/model-organism-sharing-policy) and the NIH Research Tools Policy (https://sharing.nih.gov/other-sharing-policies/research-tools-policy). Upon NIH’s issuance of the award, Recipient must implement resource sharing practices as described, and the NIH-approved Resource Sharing Plan is added to this Agreement as Attachment 4.

NIH is committed to maximizing the transparency and utility of AI models and validation/replication studies for biomedical research. In support of these goals, ADSI awards must include a plan and timeline for disseminating the AI model(s) including the named repository where the model(s) will be stored and versioned together with detailed model annotations that include the following:  

• Model Details: Basic information about the purpose of the model and its architecture.
• Model Uses: How the model is intended to be used in different applied contexts, foreseeable users of the model (including those affected by the model), and uses that are considered out of scope or misuse of the model.
• Bias, Risks, Limitations: Identify foreseeable harms, misunderstandings, and technical and sociotechnical limitations. Provide relevant warnings and potential mitigations.
• Training Details: Provide information to describe and replicate training, including the training data and privacy considerations taken for the training data.
• Evaluation: Describe the approach used to evaluate the performance of the model, the testing data used, and the performance characteristics. Include foreseeable characteristics that will influence how the model behaves. 

Standards for AI model annotations are quickly evolving, and NIH may refine these requirements during the award period, taking into consideration community input in developing the standards.

Prior to funding, OTAO may negotiate modifications to the Software and Model Sharing Plan with the Recipient. The Software and Model Sharing Plan represents a commitment by the institution (and its subcontractors, as applicable), to support and abide by the plan. The final version of the accepted Software and Model Sharing Plan will become a condition of the award. 

J. Data Management and Sharing (DMS) Policy

The Recipient agrees to comply with the Data Management and Sharing (DMS) Policy at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html and provide a DMS Plan. For ADSI funded projects and in alignment with the DMS Policy, investigators and institutions are required to plan and budget for the managing and sharing of data, submit a DMS Plan for review when applying for funding, including plans for sharing genomic data under the NIH Genomic Data Sharing Policy, as applicable, and comply with the approved DMS Plan. Upon NIH’s issuance of the award, Recipient must implement data management and sharing practices as described, and the NIH-approved DMS Plan is added to this Agreement as Attachment 4.  

K. NIH Genomic Data Sharing Policy

If applicable to the research, the Recipient agrees to comply with the NIH Genomic Data Sharing Policy at https://sharing.nih.gov/genomic-data-sharing-policy and address genomic data sharing as part of the DMS Plan. The GDS Policy sets forth expectations that ensure the broad and responsible sharing of genomic research data. Sharing research data supports the NIH mission and facilitates the translation of research results into knowledge, products, and procedures that improve human health. The DMS Plan must include elements from both the NIH Data Management and Sharing Policy and the NIH Genomic Data Sharing Policy. Recipients shall provide information on compliance with these plans in the monthly and annual progress reports. 

L. Sharing Model Organisms

Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. For more information, see : Sharing Model Organisms (https://sharing.nih.gov/other-sharing-policies/model-organism-sharing-policy). 

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#Article10Article X. Title to and Disposition of Property

A. Title to Property

Title to each item of property acquired under this Agreement with an acquisition value of $10,000 or less shall vest in the Recipient upon acquisition with no further obligation of the Parties unless otherwise determined by the OTAO. Should any item of property with an acquisition value greater than $10,000 be required, the Recipient shall obtain prior written approval of the OTAO. Title to this property shall also vest in the Recipient upon acquisition. The Recipient shall be responsible for the maintenance, repair, protection, and preservation of all property at its own expense. The Recipient’s deliverable shall not be classified as property. The Recipient shall obtain explicit written authorization from the OTAO for any transfer or disposition of all property. The Government does not accept responsibility for loss or damage to any property or work it has not accepted.

If the agreement is terminated or future years are not funded, the Recipient agrees to: 

• Purchase the equipment at an agreed-upon price (the price to represent fair market value, with the proceeds of the sale being returned to United States Treasury) or
• Transfer to an NIH research facility with title and ownership being transferred to the NIH; or
• Donate to a mutually agreed upon university or technical learning center for research purposes; or
• Any other NIH-approved disposition procedure. 

B. Property Management System Standards

The Recipient may use their own property management policies and procedures for property purchased, constructed, or fabricated as a direct cost using NIH OT award funds. 

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#Article11Article XI. Information Sharing

A. Public Release or Dissemination of Information

A Recipient planning to issue communications such as a press release concerning the outcome of OD-supported research must notify the OTAO, OTAS, and OTPO thirty (30) days in advance, with a copy to the OTPO to allow for coordination. 

B. Publications and Presentations

Publications derived from this research should acknowledge support by the NIH with reference to OTA-25-006 and the award number 1OT2OD0XXXXX-01. In addition, articles for publication or presentation will contain a statement on the title page worded substantially as follows: 

This research was, in part, funded by the National Institutes of Health (NIH) under Other Transactions Number 1OT2OD0XXXXX-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH. 

Recipient is required to fully comply with the NIH Public Access Policy, which ensures that the public has access to the published results of NIH-funded research at the NIH National Library of Medicine PubMed Central (PMC) (https://pmc.ncbi.nlm.nih.gov/). The NIH Public Access Policy is located at https://publicaccess.nih.gov/policy.htm. 

C. Prohibition from Confidential Information Release

The Recipient agrees to exclude any and all confidential information prior to public release of the material. The Parties agree that they shall take appropriate measures to protect Confidential Information received under this Agreement. Confidential Information shall mean information, any form, disclosed by one Party (Disclosing Party) to the other Party (Receiving Party) and marked as confidential or proprietary at the time of disclosure. Receiving Party agrees not to disclose Confidential Information to anyone, other than its employees performing services under this Agreement, or to use Confidential Information for any purpose other than to carry out its role pursuant to this Agreement, except as required by law or a court of competent jurisdiction.

This restriction on disclosure and use of Confidential Information survives the Recipient Party’s withdrawal or termination from this Agreement for five (5) years, unless required by law to be protected for a longer period. The previously stated obligations of confidentiality do not apply to any information that: 

• becomes a matter of public knowledge by means other than a wrongful act, omission or fault of the Recipient Party, its employees, or agents;
• is rightfully received from a third party without restriction;
• is approved for release by the submitting Party; or
• is disclosed pursuant to a court order or as required by law. 

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#Article12Article XII. Foreign Access to Technology

General

Recipient will take no possession of any International Traffic in Arms Regulations (ITAR) controlled information or materials in performance of this agreement. At no time, is any Recipient information technology product, as shipped from Recipient, subject to ITAR, and no information technology products are being provided in performance of this agreement (i.e., no Recipient products are on the United States Munitions List). 

A. Restrictions on Sale or Transfer of Technology to Foreign Firms or Institutions

1. In order to promote the national security interests of the United States and to effectuate the policies that underlie the export and ITAR regulations, the procedures stated below shall apply to any transfer of Technology under this Agreement. For purposes of this paragraph, a transfer includes a sale of the company, and sales or licensing of Technology. Transfers do not include:
   1. Information, software, and data made publicly available or open source, or
   2. sales of products or components, or
   3. licenses of software or documentation related to sales of products or components, or
   4. transfer to foreign subsidiaries of the Recipient for purposes related to this Agreement, or transfer which provides access to Technology to a Foreign Firm or Institution which is an approved source of supply or source for the performance of work under this Agreement provided that such transfer shall be limited to that necessary to allow the firm or institution to perform its approved role under this Agreement. 

Recipient shall provide written notice to the NIH OTAO and OTPO of any proposed transfer to a Foreign Firm or Institution at least sixty (60) calendar days prior to the proposed date of transfer. Such notice shall cite this Article and shall state specifically what is to be transferred and the general terms of the transfer. Within thirty (30) calendar days of receipt of the Recipient’s written notification, the NIH OTAO shall advise the Recipient whether it consents to the proposed transfer. In cases where NIH does not concur or sixty (60) calendar days after receipt and NIH provides no decision, the Recipient may utilize the procedures under Article VI, Disputes. No transfer shall take place until Parties come to an agreement. 

In the event a transfer of Technology to Foreign Firms or Institutions which is NOT approved by NIH takes place, the Recipient shall (a) refund to NIH funds paid for the development of the Technology and (b) the Government shall have a non-exclusive, nontransferable, irrevocable, royalty-free, paid-up license to practice or have practiced on behalf of the United States the Technology throughout the world for Government and any and all other purposes, particularly to effectuate the intent of this Agreement. Upon request of the Government, the Recipient shall provide written confirmation of such licenses. 

B. Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment

Other Transaction (OT) award Recipients and Sub-recipients are prohibited from expending OT funds to: 

1. Procure or obtain;
2. Extend or renew an existing OT award; or
3. Enter into a contract (or extend or renew a contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Public Law 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).
   1. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).
   2. Telecommunications or video surveillance services provided by such entities or using such equipment.
   3. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country (i.e., the People’s Republic of China). 

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#Article13Article XIII. Information Security

The Recipient is responsible for the information security of data generated under this agreement. Recipient’s information systems, electronic or hard copy, which contain Federal data funded under this award must be protected from unauthorized access. For controlled-access data used in this project, Recipients are required to follow NIH Security Best Practices for Users of Controlled-Access Data (https://sharing.nih.gov/sites/default/files/flmngr/NIH-Security-BPs-for-Users-of-Controlled-Access-Data.pdf) in addition to any other applicable security measures, including, but not limited to, those required by the repository or source of the data. 

Federal Information Security Management Act (FISMA)

Determination of the applicability of The Federal Information Security Modernization Act (FISMA) will be determined post-award of this project. If FISMA is determined to be applicable to the award in accordance with the current scope of work or if at any later date the milestones or scope of work change that requires FISMA compliance, the Recipient agrees that the Recipient's information systems, electronic or hard copy, which contain data funded under this award will be maintained in compliance with FISMA. The applicability of FISMA to NIH Recipients applies only when Recipient collects, stores, processes, transmits, or uses information on behalf of HHS or any of its component organizations. For details on FISMA, refer https://www.cisa.gov/federal-information-security-modernization-act. Notwithstanding, the Recipient agrees that all data collected and/or stored under this agreement will be processed and stored with appropriate safeguards to prevent unauthorized use of or access to said data.  In the event the activities supported through the Agreement evolve such that FISMA shall apply, the parties agree to negotiate and modify this Award to include FISMA standards. 

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#Article14Article XIV. Lower Tier Agreements

A. Definitions

1. “Lower Tier Agreement” means a written agreement between the Recipient and a Sub-Recipient.
2. “Sub-Recipient” means any legal entity that, pursuant to a Lower Tier Agreement, uses Federal funds to carry out a purpose consistent with NIH’s statutory authorities, has its performance measured in relation to whether the objectives of the NIH program were met, or has responsibility for programmatic decision making. A Sub-Recipient is distinguished from a contractor providing goods and services within normal business operations for the Recipient’s own use or that are ancillary to the operation of the NIH program, provides similar goods or services to many different purchasers, and normally operates in a competitive environment. The Recipient is responsible for determining whether a legal entity is a Sub-Recipient on a case-by-case basis, consistent with any additional guidance supplied by the NIH to support these determinations. 

B. Authorization

The Recipient is authorized to enter into Lower Tier Agreements with Sub-Recipients. The Recipient is responsible for ensuring the Sub-OT Recipient is compliant with the flow down terms. 

C. General

1. The Recipient shall give the OTAO immediate written notice of any action or suit filed and prompt notice of any claim made against the Recipient by any Sub-OT Recipient that, in the opinion of the Recipient, may result in litigation related in any way to this Agreement.
2. No funds awarded under this Agreement may be used by the Recipient to pay for costs associated with the management or administration of Lower Tier Agreements unless the Recipient has received the prior written approval of the OTAO.
3. Neither the approval nor the non-approval of a Lower Tier Agreement shall relieve the Recipient of responsibility to comply with the terms of this Agreement and perform work pursuant to the SOM. 

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#Article15Article XV. Human Subjects Research

A. Human Subjects Protections

Throughout the duration of this OT that supports human subjects research, the Recipient must obtain a Federalwide Assurance (FWA) accepted by the DHHS Office for Human Research Protections (OHRP) (https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html), and comply with its FWA, 45 CFR 46 (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html), and, as applicable, any relevant FDA regulations (e.g., 21 CFR 11, 50, 54, 56, 312, and 812) (https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs) governing the protection of human subjects and the conduct, management, and oversight of clinical trials. The Recipient shall provide to the OTAO evidence of an active FWA prior to the commencement drawing down of OT funds for, or the engagement in, of any human subject research activities contemplated under this Agreement. Further, Recipient must comply with all applicable laws and regulations relating to conducting human subjects research and the privacy and confidentiality of human subjects.  

This Agreement requires the institution to ensure that all personnel and partners who engage in human subjects research, and prior to their engagement, have completed education on the protection of human subjects described in https://grants.nih.gov/policy/humansubjects/research/training-and-resources.htm   

B. Institutional Review Board Requirements  

The Recipient agrees to provide a certification to the OTAO that the human subjects research has been approved by an appropriate Institutional Review Board (IRB), consistent with 45 CFR 46 and OHRP guidance and, as applicable 21 CFR 50 and 21 CFR 56. IRB approval must have been granted within 12 months before the execution of this Agreement to be valid. Note that the NIH requires the date of final IRB approval; conditional IRB approval is not sufficient.

The Recipient also agrees that all sites participating in a multi-site study will rely on a single Institutional Review Board (sIRB) to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46, e.g., 45 CFR 46.114. Although IRB ethical review at a participating site would be counter to the intent and goal of this provision, this provision does not prohibit any participating site from duplicating the sIRB. 

C. U.S. Food and Drug Administration Investigational New Drug (IND) and Investigational Device Exemption (IDE) Requirements  

As specified in the list below, the NIH must be alerted by the Recipient regarding certain significant communications with FDA concerning a study subject to FDA regulations, such as those clinical trials involving an Investigational New Drug (IND) or Investigational Device Exemption (IDE). The Recipient (either the PD/PI, ABO, or another person acting on behalf of the Recipient) must report to the NIH SPD and AO within 72 hours of receiving a copy of, or upon being informed of, the FDA communication, whichever occurs first. This notification requirement applies to any of the following communications from FDA to the sponsor of the IND or IDE:  

• Warning letters (whether sent to the recipient or to the commercial sponsor);  
• Notices of Initiation of Disqualification Proceedings and Opportunity to Explain;  
• Notice of Opportunity for Hearing;  
• Notice of Disqualification;  
• Consent Agreements; and  
• Clinical hold letters that pertain to breaches of good manufacturing practices, good clinical practices, or other major issue requiring significant changes in the protocol.  

The notification to NIH should be made writing at a minimum but also may be done by telephone if a written notice would delay the notification. The written notification to NIH should include a statement of the action taken or contemplated and the assistance needed to resolve the situation. 

D. Certificates of Confidentiality

Section 301(d) of the PHS Act, as amended by Section 2012 of the 21st Century Cures Act, P.L. 114-255, states that the Secretary shall issue Certificates of Confidentiality (Certificates) to NIH funded investigators or institutions engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected. Recipients that conduct biomedical, behavioral, clinical, or other research that collects or uses identifiable, sensitive information are deemed to be issued a Certificate. The Recipient is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act. Certificates issued in this manner will not be issued as a separate document (https://grants.nih.gov/policy/humansubjects/coc.htm). 

E. Data and Safety Monitoring Plan

The Recipient agrees to comply with the NIH Policy for Data and Safety Monitoring (https://grants.nih.gov/grants/guide/notice-files/not98-084.html and   https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html), which requires oversight and monitoring of all NIH- clinical trials to ensure the safety of participants and the validity and integrity of the data. If the human subjects research funded by this award is a “clinical trial,” Recipient must have a Data/Observational and Safety Monitoring Plan approved by the NIH Program Officer in consultation with other NIH staff members as appropriate. The Monitoring Plan must be commensurate with the size and complexity of the trial, the level of risk to study participants and phase of trial and may require the establishment of a Data Safety and Monitoring Board in certain circumstances.  

F. Reporting of Events and Study Problems

The Recipient agrees to have written procedures for ensuring prompt reporting to the OTPO and OTAO, as the funding agency, of: unanticipated problems involving risks to subjects or others, any serious or continuing noncompliance with 45 CFR 46, the applicable FDA regulations, or IRB requirements or determinations, and/or IRB suspension or termination of approval. This must be reported promptly to the NIH as soon as it is known (within 3 business days). 

Reports to the OTPO and OTAO must include a sufficient statement describing the nature of the unanticipated problem, serious or continuing noncompliance, and/or suspension or termination of IRB approval.   

G. ClinicalTrials.gov Requirements  

Recipient shall ensure that any clinical trial funded under this Agreement is registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting (https://clinicaltrials.gov/).  

The Recipient should familiarize itself with the requirements regarding ClinicalTrials.gov, including:

1. The authorizing statute, as amended (42 U.S.C. 282(j), also known as Sec. 801 of Public Law 110-85 (the FDA Amendments Act of 2007 or FDAAA)),  
2. The implementing regulations (42 CFR Part 11), and  
3. The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. 

In particular, the Recipient should be aware that all NIH-funded clinical trials are subject to the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and such policy is incorporated by reference.  If this award funds a clinical trial, a copy of Recipient’s plan for the dissemination of NIH-funded clinical trial information shall be attached. Without limiting the foregoing, if an applicable clinical trial is funded in whole or in part pursuant to this Agreement, any progress report shall include a certification that the Responsible Party has made all required submissions to ClinicalTrials.gov. Additionally, in general, results of applicable clinical trials are due not later than 12 months after the primary completion date. If this date occurs after the completion or termination of this Agreement, results reporting is still required in accordance with FDAAA and 42 CFR Part 11 (https://www.ecfr.gov/cgi-bin/text-dx?SID=e617ec4da22678f934787ed565bbaa5a&mc=true&node=pt42.1.11&rgn=div5).  

Generally, these regulations and policies require the following by Recipients for NIH-funded clinical trials:  

• Registration in ClinicalTrials.gov no later than 21 days after enrollment of the first participant. There should be only one registration per trial, for multi-site trials.
• Submit results to ClinicalTrials.gov no later than 12 months after the primary completion date (i.e., the date of final data collection for the primary outcome measure). If this date occurs after the completion or termination of this Agreement, results reporting is still required in accordance with FDAAA and 42 CFR Part 11.  
• Post one IRB-approved informed consent form on a public federal website designated for posting such consent forms (ClinicalTrials.gov or regulations.gov) after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

H. Inclusion Monitoring for Human Subjects Research and Clinical Trials

As mandated by the NIH Inclusion of Women and Minorities policy (https://grants.nih.gov/policy/inclusion/women-and-minorities.htm) the Recipient agrees to utilize the Human Subjects System (HSS) to enter PHS Human Subjects and Clinical Trials information for human subjects research and clinical trials funded under this Agreement. The HSS system is a shared system in eRA that enables recipients to electronically report and update their data on human subjects and clinical trials to NIH; and for NIH agency staff to monitor and manage the data. For information about HSS, refer to https://era.nih.gov/help-tutorials/hss.  

I. Investigational New Drug or Investigational Device Exemption Requirements

The Recipient agrees that, consistent with Federal regulations, research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). Exceptions must be granted in writing by the FDA, with copies provided to the NIH Program Officer.  

If the proposed human subjects research will be performed under an IND or IDE, the Recipient must provide the NIH with the name and institution of the IND or IDE sponsor, the date the IND or IDE was filed with the FDA, the FDA IND or IDE number, any written comments from the FDA, and the written responses to those comments. Recipient agrees to invite the OTPO and OTAO to meetings with the FDA regarding the IND or IDE associated with research supported by this Agreement.

The Recipient must notify the NIH Program Officer within 72 hours if the FDA places the study on clinical hold and the Recipient must also provide NIH at that time with any written comments from the FDA, written responses to the comments, and/or written documentation that the hold has been lifted. The Recipient must not use award funds for any activities restricted by the clinical hold. 

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#Article16Article XVI. Animal Welfare

Recipient shall neither expend funds from this award for research involving live vertebrate animals, nor engage in research activities involving live vertebrate animals. 

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#Article17Article XVII. Additional Administrative Requirements

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A. Financial Conflict of Interest

The NIH is committed to preserving the public’s trust that the research we support is conducted without bias and with the highest scientific and ethical standards. The Recipient shall submit their publicly accessible Financial Conflict of Interest policy to NIH via the eRA Commons Institution Profile (IPF) Module. For information about the NIH FCOI policy, refer to https://grants.nih.gov/grants/policy/coi/index.htm.  

B. Organizational Conflicts of Interest (OCI)

Recipient is required to identify and disclose all facts relevant to potential OCIs involving sub- recipients, consultants, etc. Under this section, the Recipient is responsible for providing this disclosure as appropriate when it occurs. The disclosure must include the PI/Collaborators’, and as applicable, proposed member’s OCI mitigation plan. The OCI mitigation plan must include a description of the actions the proposer has taken, or intends to take, to prevent the existence of conflicting roles that might bias the proposer’s judgment and to prevent the proposer from having an unfair competitive advantage.

The government will evaluate OCI mitigation plans to avoid, neutralize, or mitigate potential OCI issues before award issuance and to determine whether it is in the government’s interest to grant a waiver. The government may require proposers to provide additional information to assist the government in evaluating the proposer’s OCI mitigation plan. If the government determines that a proposer failed to fully disclose an OCI or failed to reasonably provide additional information requested by the government to assist in evaluating the proposer’s OCI mitigation plan, the government may reject the Detailed Plan and withdraw it from consideration for award. 

C. Organizational Responsibility Regarding Investigator Financial Conflicts-Of-Interest

The Recipient shall be deemed responsible for compliance with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Principal Investigators and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under this Agreements or proposed for such funding (which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts-of-interest. Further information is available at: 45 CFR Part 94—Responsible Prospective Contractors: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-94  

D. Closeout

The requirement for timely closeout the Recipient’s responsibility. Closeout includes ensuring timely and accurate submission of all required reports and adjustments for amounts due to the Recipient or NIH. The Statement of Milestones (SOM) will outline the specific timeline requirements for submission of the Final Financial Report, the Final Progress Report, and Final Invention Statement and Certification. 

#Article18Article XVIII. Applicable Statutes and Regulations

NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its Recipients. The signature of the Recipient Business Official (RBO) on the application certifies that the organization complies, or intends to comply, with all laws, regulations, and NIH policies applicable to the Recipient and the performance of work outlined in the “Statement of Milestones and Deliverables”. These include, but are not limited to, the following: 

A. Civil Rights Act

This Agreement is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. § 2000d) relating to nondiscrimination in Federally assisted programs. The Recipient represents that it has signed an Assurance of Compliance with the nondiscriminatory provisions of the Act and has submitted it to the HHS Office for Civil Rights (https://www.hhs.gov/civil-rights/index.html).

By accepting this award, including the obligation, expenditure, or drawdown of award funds, recipient certifies as follows:  

1. Recipient is compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., and Recipient will remain compliant for the duration of the Agreement.  
2. The above requirements are conditions of payment that go the essence of the Agreement and are therefore material terms of the Agreement.  
3. Payments under the Agreement are predicated on compliance with the above requirements, and therefore Recipient is not eligible for funding under the Agreement or to retain any funding under the Agreement absent compliance with the above requirements.  
4. Recipient acknowledges that this certification reflects a change in the government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this Agreement.  
5. Recipient acknowledges that a knowing false statement relating to Recipient’s compliance with the above requirements and/or eligibility for the Agreement may subject Recipient to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.  

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply. 

B. Harassment and Discrimination Protections

The Recipient agrees to:  

1. Ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices;  
2. Responding appropriately to allegations of discriminatory practices; and  
3. Adopting and following institutional procedure for requesting NIH prior approval of a change in the status of the Program Director/Principal Investigator (PI/PD) or other senior/key personnel if administrative or disciplinary action is taken that impacts the ability of the PI /PD or other key personnel to continue his/her role on the NIH award (https://www.nih.gov/anti-sexual-harassment/nih-awardee-organizations-those-who-work-there) 

C. No Individuals or Entities on OTA Debarred or Suspended from Receiving Federal Funds

The Recipient certifies that no individuals or entities on this Award are debarred or suspended from receiving Federal funds (https://www.gsa.gov/policy-regulations/policy/acquisition-policy/office-of-acquisition-policy/gsa-acq-policy-integrity-workforce/suspension-debarment-and-agency-protests/suspension-debarment-faq?_gl=1*1qrwsfc*_ga*NDk0NjE4Mjk5LjE3MDQ4MzM4MzQ.*_ga_HBYXWFP794*MTcyMjg3NTYxNi4xNC4xLjE3MjI4NzYyNjIuMC4wLjA & https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.6_debarment_and_suspension.htm). 

D. Lobbying Prohibition

1. No part of any appropriation contained in the Consolidated and Further Continuing Appropriations Act, 2015, or transferred pursuant to Section 4002 of Public Law 111–148 shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any State or local legislature itself, or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any State or local government, except in presentation to the executive branch of any State or local government itself.
2. No part of any appropriation contained in this Act or transferred pursuant to Section 4002 of Public Law 111–148 shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any State government, State legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local or tribal government in policymaking and administrative processes within the executive branch of that government.
3. The prohibitions in subsections (a) and (b) shall include any activity to advocate or promote any proposed, pending or future Federal, State or local tax increase, or any proposed, pending, or future requirement or restriction on any legal consumer product, including its sale or marketing, including but not limited to the advocacy or promotion of gun control. 

E. Additional Public Policy Requirements  

Recipient must comply with the public policy requirements for OT Agreements listed at: https://commonfund.nih.gov/dotm/publicpolicy. 

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#Article19Article XIX. Execution

The NOA supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions among the Parties, whether oral or written, with respect to the subject matter hereof. 

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#Attachment1Attachment 1: Statement of Milestones and Deliverables

TO BE UPDATED

Following is a sample list of possible program milestones to be reported on by the Recipient. The final list of milestones, provided in the submitted proposal and refined/modified during negotiation, will be maintained and reviewed at least monthly and throughout the life of the OT Agreement. 

A. DELIVERABLES AND SUCCESS CRITERIA

The Parties agree that the Recipient’s achievement of deliverables identified in the SOM is an important indicator of performance that will help inform NIH award management decisions, including the decision to make available additional funds as well as the decision to terminate this Agreement. 

1. Satisfaction of Deliverables 

   If the NIH determines, in its sole discretion, that the Recipient has not satisfied a deliverable as set forth in the SOM, the NIH may suspend further funding disbursements until such time as Recipient satisfies the deliverable. Costs incurred by the Recipient that exceed authorized funding levels prior to achievement of the deliverable will be the sole responsibility of the Recipient to be covered by non-NIH contingency funds. 

2. Project Planning

   No later than twenty (20) business days following execution of this Agreement, the Recipient shall submit to the OTAO, OTAS and OTPO a project plan(s) documenting in greater detail how these higher-level milestones will be achieved, including the key underlying tasks, dependencies, and workstreams that may impact participating entities. The Recipient should consider milestones in the table below when creating project plans and Gantt charts. 

3. Milestones and Deliverables

   All deliverables must be submitted to the OTAO, OTAS and OTPO with a copy (CC:) to the ADSI Mailbox ([email protected]). 

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#Attachment2Attachment 2: Statement of Budgetary Projections

TO BE UPDATED

The Recipient is authorized to expend funds up to the amounts reflected in the "Unrestricted Funds” section. It is the responsibility of the Recipient to manage within this level of obligated resources consistent with the overall goals of the Statement of Milestones. 

Human Subjects RESTRICTION:  No funds may be drawn down from the Payment Management System and no obligations may be made against Federal funds for research involving human subjects (as defined by 45 CFR Part 46) until the Recipient provides certification of all FWA and IRB approvals to the NIH consistent with Article XV, Human Subjects Research. 

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#Attachment3Attachment 3: Reporting Requirements

Quarterly status reports must be submitted via email to the assigned Other Transaction Agreement Officer (OTAO), Other Transaction Agreement Specialist (OTAS), the Other Transaction Program Officer (OTPO), and to ADSI Mailbox ([email protected]). Reports must be submitted by the Recipient Business Official (RBO). All reports shall be submitted in a single PDF file.  

Monthly Report Timeline

All reports should be submitted on the 10th business day of the month. 

• January 10, 2026
• April 10, 2026
• July 10, 2026
• October 10, 2026
• January 10, 2027
• April 10, 2027
• July 10, 2027
• October 10, 2027
• January 10, 2028
• April 10, 2028
• July 10, 2028
• October 10, 2028 

Guidance for Progress Meetings and Reports:  

1. Recipient will make the Principal Investigator (PI) and key personnel available monthly for a virtual meeting with the NIH to discuss current status of the project. In addition, the Recipient’s Business Official (RBO) and PI may need to be available for direct discussions with the NIH OTPO and OTAO as needed.  
2. The RBO will submit a single quarterly status report to the OTAO, OTAS and OTPO, consisting of technical information, that provides NIH with sufficient information to monitor the overall progress of the project. This should include:
   1. List work performed and accomplishments of agreed upon milestones.
   2. List current risks and challenges to milestone progress, anticipated impact to timelines, budget, and proposed mitigation strategies and support needed.
   3. Exhibits and appendices should be submitted as appropriate.
3. Funding
   1. List of named personnel, hourly rates, and hours charged as well as expenditures on sub-awards/contracts.
   2. Anticipated funds (total costs) remaining at the end of this reporting period.
   3. Funds spent in the reporting period and actual funds withdrew from PMS.  The table below is recommended for financial reporting. Enter the additional budget categories per approved funded budget:  

Quarterly Review

The Recipient’s schedule and budget performance shall be reviewed quarterly. Based on this review, mutually agreed upon risk mitigation plans may be implemented, objectives and milestones may be modified and/or added, and the budget for the next quarter may be updated.

Final Reporting Timeline: Due within 90 days of the last and final budget period.

Guidance for Final Report 

The recipient shall provide to the NIH the following final reports:

• Final project report that includes a general synopsis of research activity during the entire project period including total costs incurred.
• Final Financial Report: Final Federal Financial Report (FFR), SF-425, for the entire award period. The SF-425 can be accessed at https://www.grants.gov/forms/forms-repository/post-award-reporting-forms. The FFR must be uploaded via eRA. Instructions for submitting the FFR can be accessed here: https://era.nih.gov/erahelp/commons/FFR/Archive_FFR/ffr_submittingForm.htm.
• Final Invention Statement: Final Invention Statement and Certification (Form HHS 568). The HHS 568 form can be located at https://grants.nih.gov/grants/hhs568.pdf. Form HHS 568 should be submitted via eRA. Instructions for submitting the HHS 568 can be accessed here: https://www.era.nih.gov/recipients/submit-final-invention-statement.htm. A negative report is required at the completion of the Agreement, if there are no Subject Inventions. If there were no inventions, the form must indicate “None”. 

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#Attachment4Attachment 4: Data Management Sharing Plan

TO BE ADDED 

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#Attachment5Attachment 5: Background Data

TO BE ADDED 

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