EX-10.1 2 abio-ex101_151.htm EX-10.1 abio-ex101_151.htm

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended

 

                                                                                                                                                            Exhibit 10.1

 

 

 

Change Order Form

 

 

Change Order No.: 3

 

Change Order Submission Date:10 July 2015

 

Sponsor: ARCA biopharma Inc. (“Sponsor”)

 

Study Drug/Protocol No.: BUC-CLIN-303

 

Study Title:   GENETIC-AF (“Study”)

 

EPM#: 5969

 

SPS#: 200267

 

Sponsor Contact:  

[*]

 

DCRI Contacts:

 

Project Leader:

[*]

 

Business Development:

[*]

 

 

Sponsor and Duke University (“Duke” or “DCRI”) entered in a Clinical Research Agreement (the “Agreement”), effective 05 November 2013, to conduct the above-referenced Project. Change Order No. 1 was executed November 2014 and Change Order No. 2 was executed 10 March 2015. This Change Order No. 3 serves as an amendment to the Agreement and provides details related to scope changes and associated budget adjustments.  

 

Description of Scope Changes:  The budget for this Change Order No. 3 is detailed in Attachment 1:  “DCRI Detailed Fees and Pass-through Cost Estimate,” and an explanation of the change is referenced in the column called “Justification for Revised Scope”.  Unless otherwise noted, the unit costs remain the same.

 


Study Timeline

There are no changes to the timeline.

 

Description of Budget Change Summary:

 

Type

Contract Value through
Change Order No. 2

Change Order
No. 3 Value

Revised Total

DCRI Direct Fees

[*]

[*]

[*]

Pass-through Costs

[*]

[*]

[*]

Total

[*]

[*]

[*]

 

See attached budget file.

The DCRI will invoice completed units on a monthly basis.  All payments remain as agreed upon as in the Agreement unless otherwise stated.

Approval Signature:

 

Sponsor:

 

 

By:  /s/ Brian L. Selby

 

Title: V.P. Finance & Chief Accounting Officer

 

Date: August 10, 2015

Duke University:

 

 

By:  /s/ David S. Hill

 

Title: Assistant Director, Finance – DCRI

 

Date: August 27, 2015

 

 

 

 

 

 

 

 

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended


Attachment 1

 

DCRI Detailed Fees and Pass-through Cost Estimate

 

 

 

[* 4 pages of text omitted]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended