Third Amendment to Clinical Research Agreement, dated November 18, 2022, by and between Artivion, Inc. and Duke University
EX-10.13(C) 6 aort-20221231xexx1013c.htm EX-10.13(C) Document
Exhibit 10.13(c)
CERTAIN INFORMATION HAS BEEN OMITTED OR REDACTED FROM VERSION OF THIS EXHIBIT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION BECAUSE IT BOTH (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Amendment Form
| Amendment No. | 3 | ||||
| Amendment Submission Date: | November 18, 2022 | ||||
| Sponsor: | Artivion, Inc. | ||||
| Study Title: | PROACT Xa - Prospective Randomized On-X Anticoagulation Clinical Trial | ||||
| Sponsor Contact: | Melissa Thalin, Director, New Indications, Clinical Research | ||||
| DCRI Contacts: | Alma Chavez, Project Leader Clinical Operations Dawn Goodwin, Sr. Grants and Proposals Analyst, Grants and Proposals Services | ||||
Artivion, Inc. (“Sponsor”) and Duke University (“Duke” or “DCRI”) entered into a Clinical Research Agreement (the “Agreement”), effective October 10, 2019, to conduct the PROACT Xa - Prospective Randomized On-X Anticoagulation Clinical Trial. This Amendment No. 3 serves as an amendment to the Agreement and provides details related to the scope changes and associated timeline and budget adjustments resulting from the decision to terminate the Study as of September 23, 2022. This Amendment reflects the Parties written Wind Down Plan as of the date above.
Description of Scope Changes: The budget for this Amendment is detailed in Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate,” justification for the changes reflected herein are provided in the “Scope Change Justification” column.
Unused Study Materials: The Parties acknowledge Sponsor’s desire to re-sell or return all unused Study Materials and as such, Sponsor shall, or shall cause its designee to, maintain and not scrap, reject, destroy, or otherwise dispose of all remaining Study Materials unless instructed otherwise by Sponsor in writing.
Principal Investigator Change: Effective November 14, 2022, John Alexander, MD, assumed the role of Coordinating Investigator for the Study, replacing Tracy Wang, MD.
Changes to Study Timeline: This Amendment reflects the final Wind Down Plan for the Study as of the date of this Amendment. The Study is anticipated to end [ ] in accordance with the Revised Study Timeline below.
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Current Study Timeline in the Agreement:
| Study Timeline (Amendment No. 2) | ||||||||
| General Study Milestones | Number of Months | Date | ||||||
Planning/Startup | ||||||||
| Enrollment | ||||||||
| Treatment/Follow-up | ||||||||
| Last CRF In-house/Database Lock | ||||||||
Close Out/Archival/Stat Report | ||||||||
| Final Reporting | ||||||||
| TOTAL PROJECT DURATION: | ||||||||
Revised Study Timeline:
| Revised Study Timeline (Amendment No. 3) | ||||||||
| General Study Milestones | Number of Months | Date | ||||||
| Planning/Startup | ||||||||
| Enrollment | ||||||||
| Treatment/Follow-up | ||||||||
| Last CRF In-house/Database Lock | ||||||||
| Close Out/Archival/Stat Report | ||||||||
| Final Manuscript | ||||||||
| TOTAL PROJECT DURATION: | ||||||||
Description of Budget Change Summary:
| Original SUA Through Amendment No. 2 | Amendment No. 3 | Revised Contract Value | |||||||||
| DCRI Direct Fees | |||||||||||
| Pass-through Costs | |||||||||||
| Total | |||||||||||
The DCRI will invoice completed units on a monthly basis. All payments remain as agreed upon as in the Agreement unless otherwise stated.
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Approval Signatures:
Artivion, Inc.: By: ______________________________ Title:______________________________ Date:______________________________ | Duke University: By: ____________________________ Title: ___________________________ Date:___________________________ | ||||
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Attachment 1: “DCRI Detailed Fees and Pass-through Cost Estimate.”
[Omitted]
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