1. Purpose: The objective of this agreement is to establish a collaborative relationship with organizations for The Palliative Care- Heart failure Education And Research Trials (PC-HEART) Collaborative.

2. Goals: The goals of the collaborative are to:

A. Build the evidence base for palliative and supportive care in advanced HF through hypothesis-based collaborative research and clinical trials including:

i. Therapeutic approaches to manage symptoms and to improve quality of life
ii. Identification of common patient and family needs and approaches to meet these needs
iii. Methods and strategies for communication with patients and families about HF and decision-making about goals of care and available treatments to meet those goals
iv. Understanding prognosis, frailty and the course of heart failure with or without specific interventions

B. Create replicable models of care and education for comprehensive care of advanced HF and test those widely through segments of the health care delivery system (hospice, hospitals, outpatient care: HF specialty practice, general cardiology, general medical practices).

i. Utilize rapid cycle improvement to identify effective aspects of care
ii. Evaluate comprehensive care relative to patient and family quality of life

3. Levels of Participation: Collaborative Members chose one level of participation is defined as follows. Please select the level of participation you desire:

A. Research:

Develop & direct projects
Solicit funding for projects
Enroll patients in projects & in registry
Analyze data
Write/publish

B. Heart Failure Care:

Participant in development of projects
Enroll patients in projects & in registry
Design, Test & redesign improvement projects

4. Projects: Collaborative participants will participate in:

A. Research: Pilot studies identified by the collaborative & funded through PC-Heart core funding, collaboratively developed research studies, funded via grants to PC-HEART, individual investigator-developed and funded projects to which sites contribute patients.

B. Quality Improvement Initiatives (with or without funding).

C. Education: Primary Care Provider, patient/family education

5. Publications: All publications, abstracts and papers resulting from the collaborative activities must be reviewed by the manuscripts committee before being submitted for publication. All investigators wishing to be involved in the analysis, interpretation or writing of such manuscripts will be allowed to participate. Authorship will be determined by mutual consent of the involved parties.

6. Mutual Non-disclosure: You agree that elements of this interaction and/or the entire collaborative may be considered proprietary information. The ownership of this information could rest with your or with PC-HEART. Whoever holds ownership/license, you agree not to disclose any information that could jeopardize that proprietary information. PC-HEART and all of its participants will also be bound to the terms of this mutual non-disclosure.

7. Independent Contractors: In conducting clinical trials for the collaborative, you will act as an independent contractor, without the capacity to bind PC-HEART or Patient-centered Education and Research legally, and not as an agent or employee of PC-HEART or Patient-centered Education and Research.

8. Staffing and Certification: You shall not use any person (including Investigators and/or Principal Investigators) debarred or disqualified by the FDA in any capacity in connection with the performance of the services provided hereunder or the Study. Upon the execution of this Agreement, You shall provide PC-HEART and Patient-centered Education and Research with the certification attached hereto as Exhibit A. You shall ensure that all persons under you will be certified with the Responsible Conduct of Research ethics education, as stipulated by the final HHS policy.

9. Acceptance: Your signature on this document serves as formal support for the PC-HEART collaborative. You or your agent can withdraw this support at any time before formal, fiscal contracts are drawn. After such time, withdrawal from the collaborative must be done as stipulated in the terms and conditions of your contract. If these terms are acceptable, please confirm by signing the Agreement and returning it to PC-HEART/Patient-centered Education and Research.

EXHIBIT A

The undersigned hereby certify that it will not or has not employed or otherwise used in any capacity the services of any person debarred or disqualified under section 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act in connection with its activities related to The Palliative Care- Heart failure Education And Research Trials (PC-HEART) Collaborative.