FR EA

Extract to table

Pull the structured facts out of a document: parties, dates, amounts, obligations.

Extract to table / site-agreement-haverford-003.docx
site-agreement-haverford-003.docx · 1018-00004

Parties

Penterra Pharmaceuticals Corp
Sponsor Obligations Penterra Pharmaceuticals Corp
PROTOCOL CONDUCT AND SA
Initial SA
Sponsor Insurance Penterra Pharmaceuticals Corp
Data Ownership Penterra Pharmaceuticals Corp

Dates

June 28, 2023
January 21, 2019
April 1, 2023
March 31, 2024
August 14, 2023

Amounts

$80,000,000
$52,000
$75,000
$37,500
$40,000
$140,000
$4,200,000
$300,000
$1,230,000
$500,000

Obligations

157823 filed with the United States Food and Drug Administration (the "FDA"); WHEREAS, the MCTA provides that each participating clinical trial site within the Veridian Health Research Network shall execute an Individual Site Agreement in substantially the form attached as Exhibit C to the MCTA, to evidence such site's agreement to be bound by the terms and conditions of the MCTA and to set forth site-specific information, including identification of the principal investigator, enrollment allocation, budget parameters, and applicable institutional review board information; WHEREAS, Haverford Regional Medical Center is a member institution in good standing of the Veridian Health Research Network and desires to participate as Site 003 in the CLARION trial in accordance with the terms of the MCTA and this Agreement; WHEREAS, the total value of the MCTA across all thirty-eight (38) participating Veridian Network sites is approximately Eighty Million Dollars ($80,000,000) over the projected life of the CLARION trial, encompassing site fees, per-patient payments, investigator grants, network coordination fees, technology integration costs, and operational costs over a projected forty-two (42)-month enrollment period and an approximate sixty (60)-month total study duration; and WHEREAS, the Parties desire to memorialize the terms under which Haverford Regional Medical Center shall participate as Site 003 in the CLARION trial and to set forth the site-specific information applicable thereto
2 — Defined Terms Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to such terms in the MCTA
For the avoidance of doubt, all definitions set forth in Article I of the MCTA, including but not limited to the definitions of "Adverse Event," "Confidential Information," "Good Clinical Practice" or "GCP," "Informed Consent Form," "Investigational Product," "Protocol," "Serious Adverse Event," "Study Data," and "Subject," are incorporated herein by reference and shall apply to this Agreement as though set forth in full
All references to the "Site" or "Institution" in this Agreement shall mean Haverford Regional Medical Center, unless the context otherwise requires
3 — Order of Precedence In the event of any conflict, inconsistency, or ambiguity between the terms and conditions of this Agreement and the MCTA, the terms and conditions of the MCTA shall control and take precedence; provided, however, that where such conflict or inconsistency pertains to site-specific information set forth in Appendices A, B, C, or D to this Agreement—including, without limitation, site contact information, investigator identification, enrollment allocation, budget parameters, and IRB information—the site-specific terms set forth in the applicable Appendix shall control to the extent of such conflict
1 — Site Identification The following information identifies the Site for all purposes under the MCTA and this Agreement: All correspondence, investigational product shipments, regulatory documentation, and monitoring visit communications shall be directed to the addresses and contacts identified in Appendix A, unless otherwise specified in writing by the Site