heal-ot-terms-draft-community-engagement.pdf

Page | 1 terms and conditions

*note – this is a draft template, intended to serve as a baseline for Other Transactions agreements awarded by the HEAL Initiative Program. Requests by applicant(s) to modify any of the terms and conditions language will be considered by the Government on a case-by-case basis and negotiated as deemed appropriate. Failure to reach an agreement within a timeframe identified by the NIH may result in the Government not making an award. Highlighted areas within will or may change based on scope and details of proposed work.

A. Background

The purpose of this Agreement is to implement and support activities in the role of the HEAL Research

Dissemination and Engagement Center (R-DEC). The awardee(s) will work closely with the NIH HEAL

Initiative and with other awarded organizations, especially those under the HEAL Data Ecosystem, to meet the needs of the overall program. Given the urgency of the evolving opioid crisis, the results of

HEAL research must reach affected people and communities as quickly as possible. HEAL intends to disseminate findings and data as broadly as possible, including to pain and addiction researchers, the broader research community, and various non-researchers and community groups. The evidence built upon decades of NIH efforts in community-engaged research supports the benefit of enabling a more robust focus on meaningful engagement within the NIH HEAL Initiative infrastructure. To successfully reach these audiences and engage them in meaningful ways, HEAL will fund the R-DEC to interface with the HEAL research community, key partner organizations, and the intended beneficiaries of HEAL research. The R-DEC will work closely with the existing HEAL Data Ecosystem that accelerates sharing of

HEAL-generated data and enabling HEAL data to be searched, analyzed, and used to make new discoveries. Most importantly, this partner will understand and translate data and findings in ways meaningful at the community level, with input from the communities, to address needs and priorities of communities standing to benefit most from HEAL research. The R-DEC will generate, manage, and coordinate processes and products that connect the growing evidence base of HEAL research with communities, organizations, government entities, and other potential beneficiaries of HEAL research results.

B. Authorization

1. This award is made under the Other Transaction Authority (OTA) as authorized by section

402(n) of the Public Health Service Act, 42 U.S.C. 282(n). It is not intended to be, nor shall it be construed as a partnership (in the strict legal sense), corporation, or other business organization. This Agreement is not governed by the Federal Acquisition Regulation (FAR), 2 CFR 200 or the NIH Grants Policy Statement.

2. Research and Development (R&D)

Other Transaction awards issued by the National Institutes of Health (NIH) are deemed to meet the definition of “Research and Development” at 45 CFR Part§ 75.2. As such, auditees should identify NIH awards as part of the R&D cluster on the Schedule of Expenditures of

Federal Awards (SEFA). The auditor should test NIH awards for compliance as instructed in

Page | 2

Part V, Clusters of Programs. NIH recognizes that some awards may have another classification for purposes of indirect costs. The auditor is not required to report the disconnect (i.e., the award is classified as R&D for Federal Audit Requirement purposes but non-research for indirect cost rate purposes), unless the auditee is charging indirect costs at a rate other than the rate(s) specified in the award document(s).

C. Scope

1. The Awardee shall perform a coordinated research and development program resource

(hereafter referred to as “Program”) that shall be carried out in accordance with the

“Statement of Work and Milestones and Deliverables” (SOM) hereby incorporated into this

Agreement as Attachment 1 and Attachment 2.

2. Subject to the availability of funds, the Awardee shall be paid based on funds made available in accordance with the Statement of Budgetary Projections (SBP) Attachment 4 hereby incorporated in this Agreement.

D. Definitions

In this Agreement, the following definitions apply:

Agreement: This Agreement and any Attachments that are expressly incorporated in and made a part of the Agreement, including Attachment 1, Attachment 2, Attachment 3, and

Attachment 4.

Agreement Officer (AO): Individual responsible for legally committing the government to an OT award and to the Agreement through which terms and conditions are established, and for the administrative and financial aspects of the award.

Agreement Officer Representative (AOR): A designee of the Agreement Officer that provides day-to day programmatic oversight, working closely with the Agreements Officer and the Awardee.

Agreement Specialist: A designee of the Agreements Officer for administrative and financial aspects of the award.

Awardee: Renaissance Computing Institute at the University of North Carolina, the entity responsible for the administrative, financial, and programmatic activities described in the

Agreement.

Awardee Business Official (ABO): A designee of the Awardee’s institution who is responsible for legally committing the institution and is authorized to speak on behalf of the institution.

Data: Recorded information, regardless of form or method of recording, which includes but is not limited to, technical data, software, maskworks and trade secrets. The term does not include financial, administrative, cost, pricing or management information and does not include subject inventions.

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.

Page | 3

NIH/HEAL: The United States of America, as represented by the National Institutes of

Health (NIH), Helping to End Addiction Long-term (HEAL).

Invention: Any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code.

Know-How: All information including, but not limited to discoveries, formulas, materials, inventions, processes, ideas, approaches, concepts, techniques, methods, software, programs, documentation, procedures, firmware, hardware, technical data, specifications, devices, apparatus, and machines.

Made: Relates to any invention means the conception or first actual reduction to practice of such invention.

Party: Includes the Government/NIH, or the Awardee, 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.

Program: Research and development being conducted by the Awardee, as set forth in

Scope of Work.

The Program Director/Principal Investigator (PD/Pl): Individual designated by the recipient to have the appropriate level of authority and responsibility to direct the project or program supported by the Other Transaction Agreement award.

Property: Any tangible personal property other than property actually consumed during the execution of work under this Agreement.

Subject Invention: Any invention conceived or first actually reduced to practice in the performance of work under this Agreement.

Technology: Discoveries, innovations, Know-How and inventions, whether patentable or not, including computer software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, maskworks and copyrights developed under this Agreement.

Unlimited Rights: The rights to use, disclose, reproduce, 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.

E. Goals/Objectives [to be refined based on work proposed by successful applicant(s)]

1. Build and maintain trusted partnerships with communities and individuals that are part of and affected by NIH HEAL Initiative research, including but not limited to clinicians and community care providers; advocacy groups with interest in pain, addiction and other research areas relevant to HEAL such as mental and behavioral health; patients and people with lived experience; and service organizations or community-based organizations in

HEAL’s focus areas;

Page | 4

2. Develop resources and provide services to support investigators in the dissemination of study results to the broader community. This includes distilling complex research findings into audience appropriate and culturally appropriate summaries, data visualizations, and other products.

3. Lead and manage the R-DEC, its partnerships and sub-awards using proven project management capabilities

F. Teaming Agreement

Teaming Collaboration with additional partners under HEAL Initiative’s Research Dissemination and Engagement Center (R-DEC) Other Transaction Authority (OTA) Awards

Under this OTA award, it is expected that:

• HEAL R-DEC awardees are required to partner and collaborate to meet their milestones and deliverables

• Collaborative interactions are required amongst all R-DEC awardees and the HEAL Data

Ecosystem awardees;

• HEAL Initiative and NIH staff will provide deep engagement and technical oversight of the project(s), milestones, and deliverables under each award;

• R-DEC awardees will maintain amenability and flexibility to grow, enhance, and change the product(s) developed based on the input and needs of community partners, and/or HEAL investigators as new, diverse projects are onboarded across the Initiative

• Additional partners may be added in the future who would contribute specific relationships and/or capabilities

• Flexible coordination of aligned awards and efforts within the ambit of the HEAL R-DEC, including coordination with the Data Ecosystem as needed, especially to disseminate products and communication materials developed with community partner input

Given the size and complexity of the HEAL Initiative and expected data to be generated by HEAL awardees, it is necessary to ensure alignment across activities conducted by the [INSERT R-DEC awardees] and the HEAL Data Ecosystem awardees (University of Chicago and the Renascence

Computing Institute at University of North Carolina, Chapel Hill and RTI, International (RENCI/RTI, the

HEAL Stewards)), in addition to other awardees that may be onboarded in the future in support of the

HEAL R-DEC and Data Ecosystem.

Expectations and Activities:

It is expected that awardee teams will meet regularly and synergize efforts to address joint challenges that may impede or slow any teams’ deliverables for the HEAL R-DEC, as well as align efforts and prevent unnecessary duplication of efforts. This coordination will require timely sharing of project documentation related to joint activities, clear delegation of task ownership and timelines, regular progress updates, and documentation of risks and challenges. These items should be documented in a shared workspace that is also accessible to HEAL program staff. This teaming collaboration will continue throughout the entire funding period of all HEAL R-DEC awards. Relevant information must be shared and coordination and collaboration should also include HEAL Data Ecosystem awardees under appropriate circumstances. Examples of activities that will require alignment include but are not limited to:

• Final landscape analyses identifying ongoing engagement activities in HEAL and gaps where new activities are needed

• Sharing of materials relevant to understanding the data-related needs of the broad community base and partners

• Sharing of training products, communications, and data visualization-related products to be cross-promoted through Data Ecosystem venues

Page | 5

• Collection, sharing, and integration of community feedback into Data Ecosystem design, operations, user onboarding, training, and general use of Data Ecosystem products

Roles:

• Joint Oversight and Leadership: to be identified upon award

• Joint Management and Facilitation: to be identified upon award

• NIH program staff and HEAL leadership will provide support and guidance as necessary, for example, feedback regarding overall HEAL initiative strategy and mission, related scientific guidance, mitigation of disputes or disagreements, and contact points with the HEAL investigator community or partners when appropriate

• Appropriate subject matter experts and representatives of external partners should be included in discussions and decisions where relevant.

Documentation of Teaming Management:

• Shared documentation and tracking of action items, task owners, timelines, and expected products or outcomes

• Regular report out of joint progress, risks, and next steps. These report practices include sharing with NIH program staff joint meeting notes and action items by EOD after relevant meetings, creating and regularly updating a joint task tracker, and depositing related deliverables within a shared location accessible to NIH program staff and awardee team members.

• Progress, decisions, and/or outcomes included within monthly report/deliverable gantt chart and progress summary

• When required, share documentation with HEAL stakeholders beyond the immediate teams

The above components of the teaming terms are subject to change if future awardees are added as partners.

TERM

A. Term of this Agreement

The Program commences upon the date of the last signature hereon and continues for 60 months or for other such period as mutually agreed to by the Parties, 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 cease development at that point.

B. Funding

This award has been funded in the amount below.

FISCAL YEAR NIH OBLIGATED FUNDING

TBD TBD

The funds listed in the table above are available for use; however, outyear funding and extension of this agreement is based on the successful completion of the milestones as outlined in Attachment 2. Determination of the successful completion of the milestones will be at the sole discretion of the NIH.

Page | 6

No legal liability on the part of the Government for any payment may arise for performance under this agreement beyond the funding established in the Statement of Budgetary Projections as outlined in Attachment 4 unless the Awardee receives notice in writing from the Agreement Officer.

C. NIH Termination

If the NIH decides to terminate this award, the termination of the award will be considered a unilateral termination and the awardee will not have the right to appeal. Although a decision is made to terminate, the Awardee must continue to comply with the Financial Records and Reporting Section of this Agreement.

NIH and the Awardee shall negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties as a result of termination, which may include non-cancelable commitments.

D. Awardee Termination

The Awardee may terminate this Agreement by giving the NIH AO ninety (90) days written notification of their intent to do so, provided that such written notice is preceded by consultation between the Parties.

NIH and the Awardee shall negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties as a result of termination, which may include non-cancelable commitments.

E. Extending the Term

The Parties may extend by mutual written agreement the term of this Agreement as the Goals/Objectives reasonably warrant. Any extension shall be formalized through revision of the Agreement by the AO and the ABO and shall be subject to the availability of funds.

MANAGEMENT OF THE PROJECT

A. Management and Program Structure

The Awardee shall be responsible for the overall technical and program management of the Program, and technical planning and execution shall remain with the Awardee.

NIH Scientific Program Director shall provide recommendations to Awardee on developments and technical collaboration and be responsible for the review and verification of the milestone objectives and deliverables. In signing this Agreement, the ABO certifies that the Awardee will comply with all applicable assurances, and certifications referenced in the Agreement and accompanying award. The ABO’s signature further certifies that the Awardee will be accountable both for the appropriate use of funds awarded and for the performance of the SOM. The ABO is the responsible individual for ensuring that the Awardee complies with applicable Federal laws and regulations, including required certifications and assurances, its application and terms and conditions of the Agreement and accompanying award.

B. Modifications

1. As a result of meeting(s), annual review(s), or at any time during the term of the Agreement, progress or results may indicate that a change in the Goals/Objectives and/or milestones would be beneficial to Program objectives, recommendations to modify the Goals/Objectives and/or milestones may be initiated by either party. The initiating party will document in writing and submit to the other party its recommendations for modifying the Goals/Objectives and/or

Page | 7 milestones, including justifications to support the change. NIH AO and the ABO shall approve any Agreement modification on a bilateral basis.

2. NIH is not obligated to pay for additional or revised future objectives and milestones until the Goals/Objectives and/or milestones is formally revised by the AO and made part of this

3. The Scientific Program Director shall be responsible for the review and verification of any recommendations to revise or otherwise modify the Goals/Objectives and/or milestones, prospective milestones, or other proposed changes to the terms and conditions of this

4. The AO will be responsible for all official approvals related to the award. This includes but is not exclusive of documenting, communicating, and securing any necessary NIH approvals related to modifications to this Agreement.

C. Monitoring

The Awardee is responsible for managing the day-to-day operations of Agreement activities using Awardee’s established controls and policies. However, to fulfill the role in the stewardship of federal funds, the Scientific Program Director and the Scientific Program Lead will monitor and identify potential problems and areas where technical assistance might be necessary. This active monitoring can be accomplished through review of reports and correspondence, audit reports, site visits and other information, which may be requested of the Awardee. Monitoring of a project or activity will continue for as long as NIH retains a financial interest in the activity as a result of property accountability, audit, and other requirements that may continue for a period of time after the Agreement is administratively closed out and is no longer providing active Agreement support. Failure to adhere to this requirement shall constitute a material breach of this Agreement and may result in exercise of available enforcement remedies.

D. Management Systems and Procedures

The Awardee is expected to 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 Awardee may use its existing systems to manage Agreement funds and activities, provided that policies and procedures are consistently applied across its business functions.

E. Notification of Claim Against Awardee

The Awardee shall give the AO immediate written notice of any action or suit filed and prompt notice of any claim made against the Awardee by any Sub-OT Awardee that, in the opinion of the

Awardee, may result in litigation related in any way to this Agreement.

F. Lower Tier Agreement Costs

No funds awarded under this Agreement may be used by the Awardee to pay for costs associated with the management or administration of Lower Tier Agreements unless the Awardee has received the prior written approval of the AO.

Neither the approval nor the non-approval of a Lower Tier Agreement shall relieve the Awardee of responsibility to comply with the terms of this Agreement and perform work pursuant to the SOM.

G. Flow Down of Terms

Page | 8

Lower Tier Agreements must include the following Agreement terms, suitably modified to identify the Parties:

1. Obligation and Payment

2. Disputes

3. Patent Rights

4. Data Rights

5. Applicable Statutes and Regulations

6. Information Sharing

AGREEMENT ADMINISTRATION

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

Points of Contact Agreements Officer (AO):

AO Name: Quintin Hackshaw AO Email Address: quintin.hackshaw@nih.gov AO Phone Number: 301-451-2710

Agreements Specialist (AS):

AS Name: Dianna Bailey AS Email Address: dianna.bailey@nih.gov AS Phone Number: 301-402-5546

Scientific Program Director (SPD):

SPD Name: Jessica Mazerik, PhD SPD Email Address: jessica.mazerik@nih.gov SPD Phone Number: 301-402-5935

Scientific Program Lead (SPL):

SPL Name: Erin Spaniol, MS, OTR, MPH SPL Email Address: erin.spaniol@nih.gov

SPL Phone Number; 301-451-3765

Awardee Points of Contact Awardee Business Official (ABO):

ABO Name:

ABO Email Address:

ABO Phone Number:

Principal Investigator (PI):

PI Name:

PI Email Address:

PI Phone Number:

Each party may change its representatives named in this Article by written notification to the other party.

OBLIGATION AND PAYMENT

mailto:quintin.hackshaw@nih.gov mailto:dianna.bailey@nih.gov mailto:jessica.mazerik@nih.gov mailto:erin.spaniol@nih.gov

Page | 9

A. Obligation

1. The NIH’s liability to make payments to the Awardee is limited to only those funds obligated under the Agreement or by modification to the Agreement and is subject to availability of funds. The NIH may obligate funds to the Agreement incrementally.

2. If modification becomes necessary in performance of this Agreement, the NIH AO and the

ABO shall execute a revised SOM and/or milestones.

B. Payments

Awardee has an established and agrees to maintain an established accounting system which complies with Generally Accepted Accounting Principles and the requirements of this Agreement and shall ensure that appropriate arrangements have been made for receiving, distributing, and accounting for Federal funds. An acceptable accounting system is one in which all cash receipts and disbursements are controlled and documented properly.

Payments shall be made in the amounts set forth in Attachment No. XX, provided the AOR and/or

AO has verified the accomplishment of the Payable Milestones when applicable.

1.

C. Interest Earned on Advances

Awardees receiving advance payments are expected to 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, Rockville, MD 20852. Interest amounts up to $500 per year may be retained by the

Awardee for administrative expenses.

D. Limitation of Funds

In no case shall the NIH’s financial liability exceed the amount obligated under this Agreement.

E. Obligation

The liability to make payments to the Awardee is limited to only those funds obligated under the Agreement or by modification to the Agreement and is subject to availability of funds. NIH may obligate funds to the Agreement incrementally.

If modification becomes necessary in performance of this Agreement, the NIH AO and the ABO shall execute a revised SOM.

F. Appropriation Mandates

This award must comply with NIH fiscal appropriation mandates.

G. Close out of Fixed Year Appropriations Accounts

Page | 10

Fixed year appropriation accounts have a five (5)-year availability span. Awardees must draw down all appropriated fiscal year award funds no later than June 30 of the fifth fiscal 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.

H. Unobligated Balances and Actual Expenditures

Using the principle of “first in-first-out,” unobligated funds are expected to be used before newly awarded funds.

FINANCIAL RECORDS AND REPORTING

A. Financial Management System Standards

The Awardee must have in place accounting and internal control systems that 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 obligation and expenditure of funds, and awardees must notify NIH AO when problems are identified. The Awardee’s failure to establish adequate control systems constitutes a material breach of this Agreement and may result in exercise of available enforcement remedies.

B. Financial Records and Reports

The Awardee shall maintain adequate records to account for all funding under this Agreement.

Upon completion or termination of this Agreement, whichever occurs earlier, the Awardee shall furnish to the AO a copy of any final reports specified in the Goals/Objectives and/or milestones.

The Awardee’s relevant financial records are subject to examination or audit on behalf of the NIH by the NIH for a period not to exceed three (3) years after expiration of the term of this

Agreement. The AO or designee shall have direct access to sufficient records and information of the Awardee, 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.

If any litigation, claim, financial management review, or audit is started before the expiration of the three (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 document, images, and other electronic media. Institutions that rely on an electronic storage system must be able to assure such a system is stable, reliable, and maintains the integrity of the information. When storing electronic images of paper documents, the system must also assure a full, complete, and accurate representation of the original, including all official approvals.

C. Final Reporting

Within 60 days of the end or termination of this Agreement, the Recipient shall provide to the NIH the following final reports:

Final Progress Report: Final progress report that includes a general synopsis of the research activity and any noteworthy accomplishments, milestones achieved summary and including

Page | 11 results disseminated to the community. At the request of the Government, this may include a summary of lessons learned.

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/post-award-reporting-forms.html. 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://era.nih.gov/grantees/submit-final-inventionstatement.

AUDIT

A. Audit Requirements

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

F: https://www.ecfr.gov/cgi-bin/text-idx?SID=c92a1180439e91c819db8c5f87cf1f1f&node=2:1.1.2.2.1.6&rgn=div6.

A non-Federal entity that expends $750,000 or more during the non-Federal entity's fiscal year in

Federal awards must have a single or program-specific audit conducted for that year in accordance with the provisions of this part.

1. A non-Federal entity that expends $750,000 or more during the non-Federal entity's fiscal year in Federal awards must have a single audit conducted in accordance with §200.514

Scope of audit except when it elects to have a program-specific audit conducted in accordance with paragraph (2) of this section.

2. Program-specific audit election. When an auditee expends Federal awards under only one

Federal program (excluding R&D) and the Federal program's statutes, regulations, or the terms and conditions of the Federal award do not require a financial statement audit of the auditee, the auditee may elect to have a program-specific audit conducted in accordance with

§200.507 Program-specific audits. A program-specific audit may not be elected for R&D unless all of the Federal awards expended were received from the same Federal agency, or the same Federal agency and the same pass-through entity, and that Federal agency, or pass-through entity in the case of a subrecipient, approves in advance a program-specific audit.

B. Cost Principles

In general, this Agreement is subject to reimbursement of actual, allowable costs incurred and are expected to align with generally accepted and established federal costs principles for the entity receiving funding (e.g., academic, non-profit, for-profit).

DISPUTES

A. General https://www.grants.gov/forms/post-award-reporting-forms.html https://www.grants.gov/forms/post-award-reporting-forms.html https://era.nih.gov/erahelp/commons/FFR/Archive_FFR/ffr_submittingForm.htm https://grants.nih.gov/grants/hhs568.pdf https://era.nih.gov/grantees/submit-final-inventionstatement https://www.ecfr.gov/cgi-bin/text-idx?SID=c92a1180439e91c819db8c5f87cf1f1f&node=2:1.1.2.2.1.6&rgn=div6 https://www.ecfr.gov/cgi-bin/text-idx?SID=c92a1180439e91c819db8c5f87cf1f1f&node=2:1.1.2.2.1.6&rgn=div6

Page | 12

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

B. Dispute Resolution Procedures

1. Any disagreement claim or dispute between NIH and the Awardee concerning questions of fact or law arising from or in connection with this Agreement, and the Awardee, whether or not involving an alleged breach of this Agreement, may be raised only under this section.

2. Whenever disputes, disagreements, or misunderstandings arise, the Parties shall attempt to resolve the issue(s) involved by discussion and mutual agreement as soon as practicable.

C. 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 the 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.

ROLES AND RESPONSIBILITIES

A. Collaborative Effort

The administrative and funding instrument used for this program is other transactions. Other transaction awards involve substantial NIH programmatic involvement with the Awardee during the period of performance. The NIH role is to support and stimulate the award activities by involvement in a collaborative partnership with the Awardee. All award recipients and partner organizations are required to effectively collaborate and cooperate with the HEAL Program, NIH and other NIH designees. Consistent with this concept, the dominant role and prime responsibility for decisions regarding task implementation and activities will be shared, with NIH having the final decision authority.

B. Principal Director/Principal Investigator

The PD(s)/PI(s) will have the primary responsibility for:

1. Proposing approaches, design, and implementation for task/milestone completion.

2. Ensuring all participating institutions are fully integrated into the project goals.

3. Implementing and maintaining an NIH approved data security plan for all participating institutions.

4. Completing of all tasks/milestones in a timely manner as defined in the terms and conditions of award.

5. Adhering to NIH requested needs for progress review including but not limited to technical/fiscal reports, program visits, conference calls, meetings, and external consultation.

6. Collaborating with additional NIH Program partners as designated by NIH.

7. PD(s)/PI(s) has the ultimate responsibility for implementing the activities as approved by

NIH.

C. The NIH Program Manager and Scientific Program Director

The NIH Scientific Program Lead and Scientific Program Director will:

1. Provide substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

Page | 13

2. Cooperation and coordination with, or assistance in coordinating access to other NIH collaborators and/or resources.

3. Scientific and technical discussions with awardees or actions to facilitate or expedite interactions between the awardee and the HEAL collaborators.

4. Participate on steering/advisory committees as developed by the award institution and/or NIH in order to guide the course of the project.

5. Approve awardee proposed tasks/milestones and timelines.

6. Determine the appropriate means for reviewing progress including but not limited to technical/fiscal reports, program visits, conference calls, meetings, and external consultation.

7. Evaluate the awardee’s tasks/milestones progress and completion.

8. Provide technical assistance and final decisions for award directions and performance.

9. Enforce general statutory, regulatory or policy requirements.

PATENT RIGHTS

A. Allocation of Principal Rights

Unless the Awardee shall have notified NIH, in accordance with subparagraph 2 below, that the

Awardee does not intend to retain title, the Awardee shall retain the entire right, title, and interest throughout the world to each Subject Invention consistent with the provisions of this Article.

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

2. With respect to any software developed, the Awardee will own the software and data developed under this award, subject to the Government’s 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 anywhere in the world. In addition, technical solutions and methods developed under this solicitation will remain the property of the

Awardee, who may freely use them for their own commercial purposes, subject to a nonexclusive, nontransferable, irrevocable, royalty-free, paid-up license to the Government to practice, or have practiced for or on its behalf, the inventions, technical solutions and methods throughout the world.

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

1. The Awardee shall disclose each Subject Invention to NIH within four (4) months after the inventor discloses it in writing to his/her personnel responsible for patent matters. The disclosure to the 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.

2. If the Awardee determines that it does not intend to retain title to any such Invention, the Awardee shall notify NIH, in writing. However, in any case where publication, sale, or public use has initiated the one-year statutory period wherein valid patent protection can still be

Page | 14 obtained in the United States, the period for such notice may be shortened by NIH to a date that is no more than sixty (60) calendar days prior to the end of the statutory period.

3. The Awardee shall file its initial patent 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 Awardee 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.

4. The Awardee shall notify the NIH of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceedings on a patent, in any country, not less than thirty (30) calendar days before the expiration of the response period required by the relevant patent office.

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

6. The Awardee shall submit to the NIH annual listings of Subject Inventions. At the completion of the Agreement, the Awardee shall submit a comprehensive listing of all subject inventions identified during the course of the Agreement and the current status of each.

C. Conditions When the NIH May Obtain Title

1. Upon the NIH’s written request, the Awardee shall convey title to any Subject Invention to the

NIH under any of the following conditions:

a. If the Awardee fails to disclose or elects not to retain title to the Subject Invention within the times specified.

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

c. In any country in which the Awardee 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 Awardee and Protection of the Awardee’s Right to File

1. The Awardee shall retain a nonexclusive, royalty-free license throughout the world in each subject invention to which the NIH obtains title, except if the Awardee fails to disclose the Subject Invention within the times specified in Paragraph B of this Article. The Awardee’s license extends to its domestic subsidiaries and affiliates, including Canada, if any, and includes the right to grant licenses of the same scope to the extent that the Awardee was legally obligated to do so at the time the Agreement was awarded. Any extension of the Awardee’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 transferable only with the approval of the NIH, except when transferred to the successor of

Page | 15 that part of the business to which the Subject Invention pertains. The NIH approval for license transfer shall not be unreasonably withheld.

2. The Awardee’s domestic license may be revoked or modified by the 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.

3. This license shall not be revoked in that field of use or the geographical areas in which the Awardee 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 Awardee, its licensees, or the subsidiaries or affiliates have failed to achieve Practical Application in that foreign country.

4. Before revocation or modification of the license, the NIH shall furnish the Awardee a written notice of its intention to revoke or modify the license, and the Awardee 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. Action to Protect the NIH’s Interest

1. The Awardee 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 Awardee elects to retain title, and (ii) convey title to NIH when requested under Paragraph C of this Article and to enable the NIH to obtain patent protection throughout the world in that Subject Invention.

2. The Awardee 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 Awardee each Subject Invention made under this Agreement in order that the Awardee can comply with the disclosure provisions of Paragraph B of this Article. The Awardee 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.

3. The Awardee shall include, within the specification of any United States patent application and any patent issuing thereon covering a subject invention, the following statement: his invention was made with NIH support under Agreement, awarded by NIH. The NIH has certain rights in the invention.

F. Reporting on Utilization of Subject Inventions

1. The Awardee agrees to submit, during 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 Awardee or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the Awardee. The Awardee also agrees to provide additional reports as may be requested by the NIH in connection with any march-in proceedings undertaken by the NIH in accordance with Paragraph I of this Article. The NIH agrees it shall not disclose such information to persons outside the NIH without permission of the Awardee, unless required by law.

Page | 16

2. All required reporting shall be accomplished, to the extent possible, using the i-Edison reporting website: https://s-edison.info.nih.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 AO.

G. March-in Rights

The Awardee agrees that, with respect to any Subject Invention in which it has retained title, NIH has the right to require the Awardee, 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 Awardee, assignee, or exclusive licensee refuses such a request, NIH has the right to grant such a license itself if NIH determines that:

1. Such action is necessary because the Awardee or assignee has not taken effective steps, consistent with the intent of this Agreement, to achieve practical application of the Subject Invention;

2. Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the Awardee, assignee, or their licensees;

3. Such action is necessary to meet requirements for public use and such requirements are not reasonably satisfied by the Awardee, assignee, or licensees; or

4. Such action is necessary because the agreement 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.

DATA RIGHTS

A. Allocation of Principal Rights

1. The Parties agree that in consideration for NIH funding, the Awardee intends to reduce to Practical Application items, components and processes developed under this Agreement.

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

3. March -In Rights:

a) This article ensures that it obtains an unlimited rights license to all data developed under the OT Agreement and, perhaps crucially, obligates the Awardee to retain and upon request deliver that data. Although this language is flexible, the ability to obtain data and share it, in accordance with applicable controlled access protocols, is often an essential objective of any funded initiative.

B. Marking of Data

1. Pursuant to Paragraph A above, any Data delivered under this Agreement shall be marked with the following legend:

Use, duplication, or disclosure is subject to the restrictions as stated in Agreement XXXX between the Government and the Awardee.

https://s-edison.info.nih.gov/iEdison/

Page | 17

2. 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, and to have or permit others to do so.

C. Termination Data Rights

In the event of a termination of the Agreement, the NIH shall have paid-up rights in Data as described in Data Rights

TITLE TO AND DISPOSITION OF PROPERTY

A. Background Data

Background Data means any Data, Technology, or Know-How in which the Awardee holds rights of ownership as recognized by U.S. law as an intellectual creation which

1. was not reduced to Practical Application 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 Awardee’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, and to authorize others to do so.

2. The Awardee has identified and asserted in good faith all Background Data to be furnished to the Government with restrictions on use, release, or disclosure.

3. Background Data to be Furnished with Restrictions. The Awardee should identify the

Background Data or enter “none” when all Background Data will be submitted without restrictions.

B. 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 Awardee should enter the specific basis for asserting restrictions;

C. Asserted Rights Category.

Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR…