NICKIE BRUCE, BS (Mayo)TERRI EDWARDS, RN (Vanderbilt) LIBBY SALBERG, JD (Vanderbilt)

Project history• Development of contract model• Consortium structure models

“Rolling up our sleeves”• Negotiation of contract terms – focusing on

“best compromise position” for all parties Outreach – CTSA/other groups Differences with prior efforts What’s Next!

Topics of Discussion

Purpose: develop efficient contract model(s) to accelerate contracting processes across the country

Initial Focus: industry-sponsored multicenter clinical trials = ACTA and ACDA

Subgroup of 25 institutions/legal staff• Vision: Obtain agreement on all terms• Draft best compromise position

• Identify required legal terms for clinical trial agreements• Not site-specific or company-specific terms

• Non-negotiable model (legal terms) • Only budget negotiation required

PROJECT INITIATION

ACTA Contract Working GroupMaster Contract Working Group CTSA Institutions

Cincinnati Children’s Hospital Medical Center Tufts Medical Center

Duke University University of Alabama at Birmingham

Harvard Catalyst University of Arkansas for Medical Sciences

Johns Hopkins University University of California, San Francisco

Mayo Clinic University of Iowa

Medical College of Wisconsin University of Massachusetts Medical School, Worcester

The Ohio State University Medical Center University of Michigan

New York University Medical Center University of North Carolina at Chapel Hill

Northwestern University University of Rochester

Oregon Health & Science University Vanderbilt University Medical Center

Stanford University Washington University, St. Louis

Children’s National Medical Center University of Miami

University of California, Office of the President

Option 1: Lead Site Liaison:

• Registers study in ContractShare• Queries other sites’ interest• Each site executes ACDA/ACTA templates• Each site negotiates own budget

Option 2 – more “standard” consortium model: Site Coordinating Center (CC)

• CC negotiates budget on behalf of all sites• Executes ACDA and ACTA with sponsor• Subcontracts with participating sites

Consortium Models

Expediting Contracting

Easiest contract terms to negotiate (with CTSA sites and Industry Sponsors)

…hardest

Harmonizing language across sites, starting with the most feasible components

Indemnification/Limitation of Liability Confidentiality Publication Intellectual Property Subject Injury Others….

Common position → Institutions:• Policies (or statutes) limiting amount of financial

exposure • Consider straight negligence too broad • Preference: gross negligence level OR cap

Common position → Institutions:• Policies (or statutes) limiting amount of financial

exposure • Consider straight negligence too broad • Preference: gross negligence level OR cap

Common position → Industry:• Institutions should agree to all negligence on their

part; should be managing study activities in a responsible manner

Institution agrees to indemnify for 3rd party claims directly caused by Institution’s negligence in its conduct of the study

No cap required• Subject to limits under applicable law

Neither party is liable for special, consequential damages• Carving out both parties’ indemnification obligations

Common position → Institutions:• Usually require mutual confidentiality provision • Policies limiting period of nondisclosure (3 years)

Common position → Institutions:• Usually require mutual confidentiality provision • Policies limiting period of nondisclosure (3 years)

Common position → Industry:• Broader definition protecting company’s

confidential information• Extending period of nondisclosure

Language “one-sided” - protecting only confidential information from sponsor

Requiring marking; however….• Broadly protects information that “by its nature a

reasonable person would consider confidential”

Oral discussions require follow-up in writing • Protection (both parties) regarding what was

discussed/disclosed

Period of non-disclosure identified as 5 years

Common position → Institutions:• Institutions require independent right to publish

(tax-exempt status, AAHRPP compliance, internal policies)

• Policies usually require delay of no more than 12 months after study completion/termination

Common position → Institutions:• Institutions require independent right to publish

(tax-exempt status, AAHRPP compliance, internal policies)

• Policies usually require delay of no more than 12 months after study completion/termination

Common position → Industry:• Publication of aggregate data may take longer

than 12 months

Institutions retain right to independent publication; however: Institution will not publish site data until:

• Multicenter publication is published; or • 18 months after conclusion, abandonment or

termination of study at all sites; or • Sponsor confirms in writing that no multicenter

publication will occur• Prior 30 day review by sponsor, with additional

delays for sponsor to file patent applications

Common position → Institutions:• Position that IP is result of principal

investigator’s knowledge/expertise → retain ownership

• Royalty-bearing license; royalties used to help support additional research efforts

Common position → Institutions:• Position that IP is result of principal

investigator’s knowledge/expertise → retain ownership

• Royalty-bearing license; royalties used to help support additional research efforts

Common position → Industry:• Company-sponsored study; owns product• Usually require assignment of any IP resulting

from conduct of study

Protects both parties’ background IP

Language assigns ownership to sponsor of any inventions that uses/incorporates sponsor’s product

Any “other inventions” determined by U.S. patent law• If an “other invention” should occur, sponsor

granted option to an exclusive, royalty-bearing license to Institution’s rights in that invention

Common position → Institutions:• Policies require sponsor to pay for medically

necessary services related to study injuries• Cannot first seek reimbursement from Medicare/

commercial payers (policies will not allow “discrimination” based on insurance status)

Common position → Institutions:• Policies require sponsor to pay for medically

necessary services related to study injuries• Cannot first seek reimbursement from Medicare/

commercial payers (policies will not allow “discrimination” based on insurance status)

Common position → Industry:• Requirement to include broader carve-outs

limiting obligations

Broader carve-outs than institutions usually agree to:

Sponsor agrees to pay for reasonable expenses, but only to the extent expenses not attributable to: • Institution’s negligence/willful misconduct or• The natural progression of an underlying or pre-

existing condition or events

Site visits → eliminated need for specific timeframe requirements

Site visits → eliminated need for specific timeframe requirements

Termination → removed requirement for site to terminate with/without cause• Limited to patient safety reasons, material

breach, if principal investigator unavailable

Site visits → eliminated need for specific timeframe requirements

Termination → removed requirement for site to terminate with/without cause• Limited to patient safety reasons, material

breach, if principal investigator unavailable Biospecimens → subject to patient’s

informed consent form

Site visits → eliminated need for specific timeframe requirements

Termination → removed requirement for site to terminate with/without cause• Limited to patient safety reasons, material

breach, if principal investigator unavailable Biospecimens → subject to patient’s

informed consent form Governing law → intentionally omitted

Organizations: TransCelerate-very supportive; discussing internally; awaiting final University/Industry Demonstration Project (UIDP) (willing to

help nationalize the ACTA and post the agreement on UIDP website, documenting buy-in from institutions and industry)

AAHRPP-very supportive; language within compliance of domains

Industry: Pfizer (received comments/incorporated revisions) Epizyme (received comments/incorporated revisions) Shire (received comments/incorporated revisions) Eli Lilly (received comments/incorporated revisions) Johnson & Johnson (supportive; didn’t provide any revisions

to the agreement)

Use of standard templates eliminates contract negotiation delays (legal terms): • CTA = Previously 71.2 days (mean)• CDA = Previously 15 days (mean)

Study initiation/patient enrollment considerably earlier than “non-model” processes permit

61 member sites can sign ACTA without furtherlegal negotiation/time-delays required

WHY USE THIS MODEL?

Drafted contract vs. “term library”

Final agreement based on terms both parties ‘usually end up agreeing to’

Buy-in by academic medical centers Discussions with/support by industry partners

Flexibility in model application• Standard consortium model (coordinating center)• “One-on-one” capability

Significant and organized promotion

DIFFERENCES WITH PRIOR EFFORTS

61 Institutions who have accepted the ACTA (57 are CTSA or affiliated)Albert Einstein College of Medicine Stanford University University of Michigan

Boston University Tufts Medical Center University of MinnesotaChildren’s National Medical Center University of Illinois, Chicago University of New Mexico Health Sciences

CenterCincinnati Children’s Hospital Medical Center

University of Alabama at Birmingham University of North Carolina at Chapel Hill

Dartmouth College University of Arkansas for Medical Sciences University of Pennsylvania

Duke University University of California, Davis University of Pittsburgh/University of Pittsburgh Medical Center (UPMC)

Georgia Regents University University of California, Irvine University of Rochester

The Ohio State University University of California, Los Angeles University of Southern California

Indiana University School of Medicine University of California, Riverside University of Texas-Austin

Johns Hopkins University University of California, San Diego University of Texas-Houston

Mayo Clinic University of California, San Francisco University of Texas-Medical Branch

Medical College of Wisconsin University of Chicago University of Texas, San Antonio

Mount Sinai School of Medicine University of Florida Georgetown University

New York University School of Medicine University of Iowa University of Texas-Southwestern Dallas

Northwestern University University of Kansas Medical Center University of Utah

Oregon Health & Science University University of Kentucky Research Foundations

University of Wisconsin – Madison

Penn State Milton S. Hershey Medical Center University of Louisville Vanderbilt University Medical Center

Rockefeller University University of Massachusetts Medical School, Worcester

Washington University, St. Louis

Scripps Health University of Miami Yale University

Case Western University University Hospitals Case Medical Center University of Kansas

Rush University Medical Center 36

Accelerated Clinical Trial Agreement (ACTA)• Company-sponsored, multicenter clinical trials• Option 1 model (site/sponsor)

Web Portal – https://www.ara4us.org/• List of institutions/companies agreeing to terms• House latest version of ACTA

NOW IN PLACE

The terms reflect a “best compromise” position

Continue outreach to Industry and other sites (CTSA and non-CTSA groups): Pfizer, Eli Lilly, Celgene, Merck, Genentech (and others…)

Model Agreements & Guidelines International (MAGI), WIRB/Copernicus group

Patient-Centered Outcomes Research Inst. (PCORI)

Assoc. for Clinical & Translational Science (ACTS)

Website registration/list of participating entities Initiate pilots with Industry

Infraredx, Inc.Currently in discussions….

Revise ACTA as needed for sustainability

What is next?

Future agreements planned:

• CDA (incorporating ACTA terms)• ACTA for CRO arrangements • PI-Initiated version of the ACTA• Prime template with subcontracts (Option 2 model)

• Others……

Coming soon!

Questions?