ex10-2.htm


Exhibit 10.2 




 

 




 

Page 2 of 3


  

SECTION SF 30 BLOCK 14 CONTINUATION PAGE 

 

SUMMARY OF CHANGES  

 

 

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE 

 

 

 

The following have been added by full text: 

BLOCK 14 DESCRIPTION OF MOD

The subject contract is modified for the following purpose:

 

1) Incorporate (by reference) AcelRx’s revised SOW, dated 30 Nov 2016, which includes the following additions: Develop/test primary and/or secondary packaging changes from reflective white package to non-reflective/non-white package; Conduct additional stability testing; and Prepare for FDA Advisory Committee as a result of FDA's recent Opioid Action Plan requirement.

 

2) Extend the contract period of performance by 11 months from 11-May-2015 thru 09-Mar-2017 to 11-May-2015 thru 28-Feb-2018 to accommodate packaging changes, stability testing, and Advisory Committee preparation.

 

3) Incorporate (by reference) the following AcelRx supporting documents: Issue Summary Report dated 11 Apr 2016 (request item #3); Issue Summary Report dated 30 Nov 2016; Revised Budget Justification dated 30 Nov 2016; Revised Contract timeline dated 30 Nov 2016; and Revised Spend Plan dated 30 Nov 2016.

 

4) Rescind the Key Personnel related language from mod P00004 “the contractor will invoice at the same labor rate for the position”. The overall contract cost will not be impacted due to lower than estimated labor charges for the position in 2015; however, the labor rate will not be the same.

 

As a result of this modification, the total cost and funded amount for this contract will not change. All other terms and conditions remain unchanged. See Summary of Changes for details.

 

  

SECTION A - SOLICITATION/CONTRACT FORM 

  

 

The following have been modified: 

ADDITIONAL INFORMATION

The Contractor’s final proposal dated 13 February 2015 is herein incorporated by reference. 

The Contractor’s final proposal (for LRIP option) dated 16 April 2015 is herein incorporated by reference. 

 

March 2016 (Mod P00005): The ARX-04 clinical program had to be revised based on the outcome of the Contractor’s pre-New Drug Application (NDA) meeting with the U. S. Food and Drug Administration (FDA). The Contractor’s Issue Summary Report (ISR), dated 14 January 2016, is herein incorporated by reference. 

 

March 2017 (Mod P00007): Packaging changes are required. Additional stability testing is required. Based on new requirements in the recently updated FDA “Opioid Action Plan” AcelRx will be required to appear before an expert Advisory Committee prior to NDA approval of the ARX-04 sublingual sufentanil tablet. 

The following AcelRx documents are herein incorporated by reference: 

1. Revised Statement of Work (SOW) dated 30 Nov 2016. 

2. Issue Summary Report dated 11 Apr 2016 (request item #3).

3. Issue Summary Report dated 30 Nov 2016. 

4. Revised Budget Justification dated 30 Nov 2016. 

5. Revised Contract timeline dated 30 Nov 2016. 

6. Revised Spend Plan dated 30 Nov 2016. 

 


 

 




 

Page 3 of 3


  

Government Property:

No Government-furnished property will be used in the performance of this contract. 

No Contractor-acquired, Government-owned property will be purchased for this contract. 

All equipment used in the performance of this contract (except where subcontractors are utilized) will be purchased by AcelRx using their own funds. 

 

 

 

SECTION F - DELIVERIES OR PERFORMANCE 

 

The following Delivery Schedule item for CLIN 0001 has been changed from:

 

	
 
	
DELIVERY DATE 
	
QUANTITY 
	
SHIP TO ADDRESS 
	
DODAAC 

	
 
	
 
	
 
	
 
	
 

	
 
	
POP 11-MAY-2015 TO

09-MAR-2017 
	
N/A 
	
FORT DETRICK-USAMMDA

FORT DETRICK-USAMMDA

1430 FORT DETRICK

FREDERICK MD 21702

FOB: Destination 
	
W806YH 



  

To:

 

	
 
	
DELIVERY DATE 
	
QUANTITY 
	
SHIP TO ADDRESS 
	
DODAAC 

	
 
	
 
	
 
	
 
	
 

	
 
	
POP 11-MAY-2015 TO

28-FEB-2018 
	
N/A 
	
FORT DETRICK-USAMMDA

FORT DETRICK-USAMMDA

1430 FORT DETRICK

FREDERICK MD 21702

FOB: Destination 
	
W806YH 



  

(End of Summary of Changes)