Document:

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 amendedabio-ex102_152.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 10.2

 

 

Change Order Form

 

 

Change Order No.: 4

 

Change Order Submission Date:08 October 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, Change Order No. 2 was executed 10 March 2015, and Change Order No. 3 was executed on 27 August 2015. This Change Order No. 4 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. 4 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.

 

 

 

Description of Budget Change Summary:

 

				
	
Type
	
Contract Value through

Change Order No. 3
	
Change Order

No. 4 Value
	
Revised Total

	
DCRI Direct Fees
	
[*]
	
[*]
	
[*]

	
Pass-through Costs
	
[*]
	
[*]
	
[*]

	
Total
	
[*]
	
[*]
	
[*]

 

See attached timeline and budget files.

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: November 10, 2015
	
Duke University:

 

 

By:  /s/ David S. Hill

 

Title:  Assistant Director, Finance – DCRI

 

Date: November 5, 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

 

 

 

[* 5 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 amendedEX-10.1

 Exhibit 10.1 
  

					
	

	  		  	Grifols S.A.
	  		  	24 Avda. Generalitat, 152- 158
	  		  	Polfgono Can San Joan
	  		  	08174 - Sant Cugat del
	  		  	Valles Spain
			
		  		  	www.grifols.com

 July 20, 2015 

Aradigm Corporation 
 3929 Point Eden Way 

Hayward, CA 94545 
 Attention: Igor Gonda 

 

	 	Re:	Aradigm Corporation Board Observer Rights Agreement  

 Dear Dr. Gonda, 

This letter agreement will confirm our agreement in connect ion to the composition of the board of directors (the “Board”) of
Aradigm Corporation (the “Company”} as set forth in the Governance Agreement dated August 27, 2013 (“Governance Agreement”) by and between the Company and Grifols, S.A (“Grifols”). 

Pursuant to Section 3. (a) of the Governance Agreement, the Board shall consist of the Chief Executive Officer, three Independent
Directors, and two persons selected by Grifols (the second person, the “Second Grifols Designee”). We have agreed that Grifols’ right to appoint a board observer to attend meetings of the Board in a non-voting, observer status
(“Observer”) hereunder shall satisfy the Company’s obligation to nominate the Second Grifols Designee pursuant to Section 3.1 of the Governance Agreement. 

Lafmin Morgan shall resign his current position as a Member of Aradigm’s Board of Directors and shall be thereafter designated as
Grifols’ Observer. Grifols may change the Observer or return to a Second Grifols Designee on the Board at any time upon reasonable prior notice to the Company; provided, however, that any such subsequent action shall be approved by the
Board. 
 Board Observer Rights 
 The
Company will ( i) permit the Observer to attend all meetings of the Board (“Board Meetings”) in a non-voting observer capacity and ( ii} shall provide to the Observer, concurrent ly with the members of the applicable Board, and in the same
manner, notice of each such meeting and a copy of all materials provided to such members in connect ion with Board meetings {the “Board Materials”). The Board Materials shall include all consents and other materials and information
provided to the Board with respect to any written consent in lieu of a meeting. 
 Notwithstanding the foregoing, the Observer may be
excluded from any portion of any Board Meeting and shall not be entitled to receive any Board Materials (i) to the extent necessary to preserve the attorney-client privilege of either of the Company or the Board, or (ii) if the Board
determines in good faith that the matters to be discussed (or otherwise disclosed in the Board Materials, as applicable) are (a) of such a highly confidential and sensitive nature that it would not be in the best interests of the Company for
such matters to be disclosed to the Observer, or (b} that the Observer (or their affiliates) has interests with respect to a matter that are potentially in conflict with the interests of the Company. 

Confidentiality and Non-Disclosure 

Grifols and the Observer agree that any confidential information, knowledge or data concerning or relating to the business or financial affairs
of the Company to which the Observer has been or shall become privy by reason of this letter or the rights it creates, shall be “Confidential Information” of the Company for purposes of Section 11.1 of that 

  
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certain License and Collaboration Agreement entered into as of August 27, 2013 by and between Grifols and the Company (the “Collaboration Agreement”). Grifols and the Observer
agree to hold in confidence and not to use any Confidential Information provided or learned in connection with their rights under this Agreement, except to the extent expressly allowed by the Collaboration Agreement. 

Non-Assignability and Termination 
 The
board observation rights described herein are not assignable by Grifols and shall terminate and be of no further force or effect upon the earlier of (a) when Grifols elects to re-designate the Second Grifols Designee in lieu of the board
observation rights granted herein; and (b) when Grifols no longer has a right to designate the Second Grifols Designee under the Governance Agreement. The confidentiality provisions hereof will survive any such termination. 

 

	
	Very truly yours,
	
	GRIFOLS, S,A.
	
	 /s/ David. I. Bell

	David. I. Bell
	Vice President

  

							
	Accepted and agreed:	 	
		
	ARADIGM CORPORATION	 	
				
	By:	 	 /s/ Igor Gonda
	 		 	
		 	Dr. Igor Gonda, Chief Executive Officer	 		 	
				
	Date:	 	     9/1/15
	 		 	
		
	OBSERVER:	 	
		
	Lafmin Morgan	 	
				
	By:	 	 /s/ Lafmin Morgan
	 		 	
				
	Date:	 	     9/1/15
	 		 	

  
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